COMPASS Pathways plc (NASDAQ: CMPS) is a UK-incorporated, US-listed clinical-stage biotechnology company developing COMP360, a proprietary synthetic psilocybin formulation, primarily for treatment-resistant depression (TRD), with additional indications in post-traumatic stress disorder (PTSD) and anorexia nervosa (per the FY2025 10-K, Item 1, filed 2026-03-24). For the year ended December 31, 2025 the Company reported no commercial revenue, an operating loss of -$179.0 million (per EDGAR XBRL OperatingIncomeLoss, 10-K period ending 2025-12-31), a net loss of -$287.9 million (per the FY2025 10-K, Item 7), and research and development expense of $118.4 million (per the FY2025 10-K, Item 7, filed 2026-03-24). The Company ended Q1 2026 with $466.0 million of cash and cash equivalents (per the Q1 2026 10-Q, filed 2026-05-13), funding operations into 2028 (per the FY2025 10-K, Item 7). The stock last traded at $11.81 against a 52-week range of $2.25 to $12.235 (per yfinance, pulled 2026-05-26), with Q1 2026 reported on 2026-05-13 and the 2026 Annual General Meeting scheduled for 2026-05-27. COMPASS Pathways employed 156 people as of 2025-12-31 — 49% in the US and 51% in the UK (per the FY2025 10-K, Item 1, filed 2026-03-24).

1. Company Snapshot

Field	Value
Name	COMPASS Pathways plc (per the FY2025 10-K, cover page, filed 2026-03-24)
Ticker / Exchange	CMPS / Nasdaq Global Select Market (per the FY2025 10-K, cover page)
Sector / Industry	Healthcare / Biotechnology — clinical-stage (per the FY2025 10-K, Item 1; yfinance pulled 2026-05-26 lists Industry as "Medical Care Facilities" which appears mis-classified)
Market cap	$1.59bn (per yfinance, 2026-05-26)
Enterprise value	$1.18bn (per yfinance, 2026-05-26)
FY2025 revenue	$0 — no commercial product (per the FY2025 10-K, Item 7, filed 2026-03-24)
FY2025 operating income (EDGAR XBRL)	-$179.0M (per EDGAR XBRL OperatingIncomeLoss, 10-K period ending 2025-12-31)
FY2025 free cash flow	-$157.2M (per yfinance annual cashflow, FY2025)
Gross margin (FY2025)	not meaningful — no revenue (per the FY2025 10-K, Item 7)
Net margin (FY2025)	not meaningful — no revenue; net loss -$287.9M (per the FY2025 10-K, Item 7)
Employees	156 (49% US, 51% UK) as of 2025-12-31 (per the FY2025 10-K, Item 1, filed 2026-03-24)
CEO	Kabir Nath, President & CEO (per the FY2025 10-K and insider transaction filings via yfinance, pulled 2026-05-26)
Headquarters	London, United Kingdom — registered office 3rd Floor, 1 Ashley Road, Altrincham, Cheshire, WA14 2DT; additional offices in New York (per the FY2025 10-K, filed 2026-03-24)
Website	compasspathways.com (per yfinance, pulled 2026-05-26)
Fiscal year-end	December 31 (per the FY2025 10-K, filed 2026-03-24)
Next earnings	Q2 2026 (Q1 2026 reported 2026-05-13 per the Q1 2026 8-K; next date not disclosed in this report's source data)
Dividend yield	None — Company has never paid a dividend (per yfinance, pulled 2026-05-26; the FY2025 10-K)
52-week high	$12.235 (per yfinance, pulled 2026-05-26)
52-week low	$2.25 (per yfinance, pulled 2026-05-26)
Short interest	7.34% of float (per yfinance shortPercentOfFloat, pulled 2026-05-26)

2. Bull Case vs Bear Case

Bull Case

• Both pivotal Phase 3 trials hit their primary endpoints. Per the FY2025 10-K (Item 1, filed 2026-03-24): the COMP005 trial (n=258) demonstrated a least-square-means treatment difference of -7.2 on MADRS for a single 25mg dose of COMP360 versus placebo at week 6, with a p-value of <0.001. The COMP006 trial (n=581) demonstrated a clinically meaningful difference of -3.8 on MADRS for two fixed 25mg doses (administered three weeks apart) versus 1mg, with a p-value of <0.001 (announced 2026-02-17 per Compass Pathways).
• FDA granted rolling NDA review and a Commissioner's National Priority Voucher (CNPV). Per Compass Pathways' announcement (2026-04-24): the FDA granted a rolling NDA submission for COMP360 in TRD and awarded the company a CNPV, which would enable an ultra-accelerated FDA review of 1–2 months following final NDA submission, while maintaining the agency's safety and efficacy standards.
• Strongly funded balance sheet — runway into 2028. Per the FY2025 10-K (Item 7, filed 2026-03-24): the Company expects that its cash, cash equivalents and short-term investments together with the proceeds from the exercise of all outstanding 2025 ADS Warrants will be sufficient to fund operating expenses and capital expenditure requirements into 2028. Per the Q1 2026 10-Q (filed 2026-05-13): cash and cash equivalents stood at $466.0 million at 2026-03-31, up from $149.6 million at 2025-12-31, supported by $87.9 million of proceeds from ADS warrant exercises.
• NDA submission and potential 2027 launch are line-of-sight. Per the Q1 2026 earnings release (2026-05-13): the Company expects to report 26-week Part B data from COMP006 in early Q3 2026, complete its NDA submission in Q4 2026, and be "launch ready" by year-end 2026, with the CNPV potentially compressing FDA review to 1–2 months thereafter.
• Pipeline extends beyond TRD. Per the FY2025 10-K (Item 1, filed 2026-03-24): COMPASS has finalised the design of a Phase 2b/3 trial for COMP360 in PTSD, and is also pursuing studies in anorexia nervosa, broadening the long-term commercial opportunity beyond the lead TRD indication.

Bear Case

• No commercial product and a deepening accumulated deficit. Per the FY2025 10-K (Item 7, filed 2026-03-24): the Company has reported zero commercial revenue since inception, FY2025 operating loss widened to -$179.0 million (EDGAR XBRL) from -$157.1 million in FY2024, and net loss expanded to -$287.9 million in FY2025 from -$155.1 million in FY2024, taking the accumulated deficit to -$822.6 million.
• Material historical dilution to fund development. Per the FY2025 10-K (balance sheet, filed 2026-03-24): shares outstanding rose from 42.6 million at FY2022 year-end to 96.1 million at FY2025 year-end, and stood at approximately 134.9 million as of 2026-05-26 (per yfinance) — roughly a 3.2x increase over three years, with proceeds from ordinary share, pre-funded warrant and ADS warrant issuances funding the burn.
• GAAP earnings are volatile because of warrant fair-value remeasurement. Per the Q1 2026 10-Q (filed 2026-05-13): GAAP net income was +$91.2 million in Q1 2026 even though loss from operations was -$42.9 million, because a fair-value change in warrant liabilities contributed +$130.9 million of other income. Per the FY2025 10-K (Item 7) and Q3/Q4 2025 prints: Q3 2025 reported a -$137.7 million net loss versus a -$36.6 million operating loss for similar reasons, in the opposite direction.
• Psilocybin remains a Schedule I controlled substance and is novel. Per the FY2025 10-K (Item 1A, filed 2026-03-24): COMP360 contains psilocybin, which is currently a Schedule I controlled substance in the US, requiring DEA scheduling action and certified treatment-centre delivery alongside any FDA approval — adding regulatory, operational and reimbursement complexity that other oral antidepressants do not face.
• Founder/early-backer overhang and concentrated specialist ownership. Per insider transactions via yfinance and the FY2025 10-K (filed 2026-03-24): co-founders George Goldsmith and Ekaterina Malievskaia have sold material amounts of stock (including sales at $6.43 per share on 2024-10-24), and atai Life Sciences NV — a long-standing related-party investor — sold 2.66 million shares at $6.05 in September 2024. Institutional ownership is highly concentrated in specialist healthcare/biotech funds (Deep Track 9.01%, RTW 7.88%), exposing the stock to fast positioning shifts.

3. What Does COMPASS Pathways Actually Do?

COMPASS Pathways is a single-asset, clinical-stage biotechnology company. Per the FY2025 10-K (Item 1, filed 2026-03-24): its entire revenue model today is investigational — there are no commercial products and no product revenue. The reportable revenue line in the 10-K is zero in each of FY2022, FY2023, FY2024 and FY2025.

Revenue line	FY2025	FY2024	FY2023	FY2022
Product revenue	$0	$0	$0	$0
Other / collaboration revenue	$0	$0	$0	$0
Total revenue	$0	$0	$0	$0

Source: the FY2025 10-K, Item 7, filed 2026-03-24.

In plain English, the company is developing COMP360 — a proprietary, GMP-grade synthetic formulation of psilocybin (the active compound in psychedelic mushrooms) — to be administered as a single or repeat dose in a supervised treatment setting alongside psychological support, for patients whose major depressive disorder has not responded to two or more standard antidepressants (so-called treatment-resistant depression, or TRD) (per the FY2025 10-K, Item 1, filed 2026-03-24). The primary efficacy measure is the Montgomery–Åsberg Depression Rating Scale (MADRS), an interviewer-administered depression severity score. The Company also has Phase 2/3 programs in PTSD and Phase 2 work in anorexia nervosa (per the FY2025 10-K, Item 1).

Geographically, COMPASS' R&D is split between the United Kingdom (London headquarters, with UK R&D tax-credit benefit) and the United States (clinical operations, New York office) (per the FY2025 10-K, Item 1 and Q1 2026 10-Q, filed 2026-05-13).

4. The Business Model

Per the FY2025 10-K (Item 1, filed 2026-03-24): COMPASS Pathways' business model is, today, a pre-commercial R&D model — drug development funded by equity issuance, ADS warrant exercises and UK R&D tax credits, with future revenue contingent on FDA (and later non-US) approval of COMP360. There is no product, no collaboration revenue and no royalty income.

The post-launch operating model the Company describes has three load-bearing elements (per the FY2025 10-K, Item 1, filed 2026-03-24). First, COMP360 must be delivered as a medically supervised treatment session — patients receive the psilocybin dose at a certified treatment centre and undergo a multi-hour session with psychological support — which means the addressable channel is specialist clinics and centres rather than retail pharmacies, and capacity ramp depends on training and certifying providers. Second, intellectual property protection rests on a portfolio around the synthetic psilocybin composition of matter and use methods, and on regulatory exclusivities (Breakthrough Therapy designation from 2018; CNPV awarded 2026-04-24). Third, manufacturing is via contract manufacturing organisations (CMOs); COMPASS does not own manufacturing facilities.

A defining feature of the financing model is the warrant capital stack. Per the Q1 2026 10-Q (filed 2026-05-13): the Company has both 2025 ADS Warrants (issued in a January 2025 underwritten offering) and pre-funded warrants/PIPE warrants outstanding; these are accounted for as liabilities at fair value, so quarterly GAAP earnings move sharply with the share price even though no cash changes hands.

5. Financial Health

5-year income trend (per the FY2025 10-K Item 7 and yfinance annual financials; FY2021 not in source data):

FY	Revenue	Operating income	Net income	Diluted EPS	Free cash flow
FY2025	$0	-$179.0M (EDGAR XBRL)	-$287.9M	-$3.08	-$157.2M
FY2024	$0	-$157.1M	-$155.1M	-$2.30	-$119.2M
FY2023	$0	-$124.0M	-$118.5M	-$2.32	-$97.4M
FY2022	$0	-$96.0M	-$91.5M	-$2.16	-$106.0M
FY2021	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data

Per the FY2025 10-K (Item 7, filed 2026-03-24): FY2025 R&D expense of $118.4 million was essentially flat versus FY2024's $119.0 million as the COMP005 and COMP006 Phase 3 trials read out; SG&A rose to $60.6 million (FY2024: $59.2 million) as launch-preparation activities began. The wider gap between FY2025 net loss (-$287.9 million) and operating loss (-$179.0 million) versus FY2024 reflects fair-value remeasurement on warrant liabilities tied to a sharply rising share price during 2025.

Balance sheet (per the FY2025 10-K, balance sheet, filed 2026-03-24 and the Q1 2026 10-Q, filed 2026-05-13):

Period	Cash & equivalents (+ ST inv)	Total debt	Stockholders' equity (deficit)	Shares outstanding	Buybacks
Q1 2026 (2026-03-31)	$466.0M	not disclosed in this report's source data — see Q1 2026 10-Q	not disclosed in this report's source data — see Q1 2026 10-Q	~134.9M (per yfinance, pulled 2026-05-26)	$0
FY2025 (2025-12-31)	$149.6M	$35.0M	-$52.8M	96.1M	$0
FY2024	$165.1M	$32.2M	$154.7M	68.6M	$0
FY2023	$220.2M	$33.1M	$225.7M	61.9M	$0
FY2022	$143.2M	$1.9M	$181.3M	42.6M	$0

Per the FY2025 10-K (balance sheet, filed 2026-03-24): the FY2024-to-FY2025 movement to a stockholders' deficit reflects the FY2025 net loss of -$287.9 million partially offset by $140.4 million of capital stock issuance during the year. Accumulated deficit rose to -$822.6 million at FY2025 year-end. Total debt of $35.0 million is small relative to cash and is comprised primarily of operating-lease liabilities (per the FY2025 10-K, Notes to the consolidated financial statements).

Quarterly trend, last 5 quarters (per yfinance quarterly financials and the Q1 2026 earnings release dated 2026-05-13):

Quarter	Revenue	Operating income	Net income (loss)	Diluted EPS	Free cash flow
Q1 2026 (2026-03-31)	$0	-$40.4M	+$91.2M (driven by +$130.9M non-cash fair-value gain on warrant liabilities)	-$0.30	not disclosed in this report's source data
Q4 2025 (2025-12-31)	$0	-$58.9M	-$93.9M	-$1.00	not disclosed in this report's source data
Q3 2025 (2025-09-30)	$0	-$36.6M	-$137.7M (large non-cash fair-value loss as the share price rose)	-$1.44	not disclosed in this report's source data
Q2 2025 (2025-06-30)	$0	-$38.6M	-$38.4M	-$0.41	not disclosed in this report's source data
Q1 2025 (2025-03-31)	$0	-$41.2M	-$17.9M	-$0.24	not disclosed in this report's source data

Note on EPS arithmetic in Q1 2026: GAAP net income of +$91.2 million is positive, but the diluted EPS calculation (per the Q1 2026 10-Q, filed 2026-05-13) reverses the +$130.9 million warrant fair-value gain when those warrants are dilutive, producing a numerator of -$39.7 million and a diluted EPS of -$0.30 — i.e., the GAAP net income and the diluted EPS look directionally opposite because of the warrant accounting.

6. Valuation & Market Data

Raw market data only — no commentary on cheap or expensive.

Metric	Value
Share price	$11.81 (per yfinance, pulled 2026-05-26)
Previous close	$11.59 (per yfinance, pulled 2026-05-26)
Day range	$11.59 – $12.235 (per yfinance, pulled 2026-05-26)
52-week high / low	$12.235 / $2.25 (per yfinance, pulled 2026-05-26)
Market cap	$1.59bn (per yfinance, pulled 2026-05-26)
Enterprise value	$1.18bn (per yfinance, pulled 2026-05-26)
Shares outstanding	134.9M (per yfinance, pulled 2026-05-26; 96.1M reported at 2025-12-31 in the FY2025 10-K, balance sheet)
Float	101.5M (per yfinance, pulled 2026-05-26)
Avg daily volume (10d)	4.57M (per yfinance averageVolume10days, pulled 2026-05-26)
Volume (latest)	3.87M (per yfinance, pulled 2026-05-26)
Beta	2.41 (per yfinance, pulled 2026-05-26)
Trailing P/E (GAAP)	not disclosed in this report's source data — net loss in TTM (per yfinance, pulled 2026-05-26)
Forward P/E	-11.18 (per yfinance, pulled 2026-05-26)
P/S (TTM)	not disclosed in this report's source data — no revenue (per yfinance, pulled 2026-05-26)
P/B	4.88 (per yfinance, pulled 2026-05-26)
EV / Revenue	not disclosed in this report's source data — no revenue (per yfinance, pulled 2026-05-26)
EV / EBITDA	-6.78 (per yfinance, pulled 2026-05-26)
P / FCF	not disclosed in this report's source data — FCF negative (per yfinance, pulled 2026-05-26)
Gross margin (TTM)	not meaningful — no revenue (per yfinance, pulled 2026-05-26)
Operating margin (TTM GAAP)	not meaningful — no revenue (per yfinance, pulled 2026-05-26)
Net margin (TTM)	not meaningful — no revenue (per yfinance, pulled 2026-05-26)
ROE	-68.48% (per yfinance, pulled 2026-05-26)
ROA	-25.64% (per yfinance, pulled 2026-05-26)
Debt-to-equity	16.32 (per yfinance, pulled 2026-05-26)
Current ratio	3.32 (per yfinance, pulled 2026-05-26)
Dividend yield	None — Company has never paid a dividend (per yfinance, pulled 2026-05-26)
Short interest	7.34% of float (per yfinance shortPercentOfFloat, pulled 2026-05-26)
Put / call ratio	not disclosed in this report's source data

7. What Are They Building / What's Coming

Per the FY2025 10-K (Item 1, filed 2026-03-24), the Q1 2026 earnings release (2026-05-13) and named public announcements, COMPASS Pathways' near-term roadmap includes:

• COMP360 NDA in TRD — rolling submission underway, CNPV-eligible. Per Compass Pathways' announcement (2026-04-24): the FDA granted a rolling NDA submission for COMP360 in treatment-resistant depression and awarded a Commissioner's National Priority Voucher (CNPV), which would entitle COMP360 to an ultra-accelerated 1–2 month FDA review following final NDA submission while preserving the agency's safety and efficacy standards.
• 26-week COMP006 Part B data — early Q3 2026; final NDA Q4 2026. Per the Q1 2026 earnings release (2026-05-13): the Company expects to report 26-week (Part B) data from COMP006 in early Q3 2026 and to complete final NDA submission for COMP360 in Q4 2026, with launch-readiness activities targeted for year-end 2026.
• PTSD — Phase 2b/3 design finalised. Per the FY2025 10-K (Item 1, filed 2026-03-24): the Company has finalised the design of a Phase 2b/3 clinical trial of COMP360 in PTSD, addressing trauma-related psychiatric disease and broadening the long-term opportunity beyond TRD.
• Anorexia nervosa and other indications. Per the FY2025 10-K (Item 1, filed 2026-03-24): a Phase II clinical trial of COMP360 in anorexia nervosa is underway, with additional indications under preclinical and translational evaluation.
• Commercial launch readiness. Per the FY2025 10-K (Item 1, filed 2026-03-24) and the Q1 2026 earnings release (2026-05-13): the Company is scaling commercialisation, marketing and manufacturing capability and certifying treatment-centre delivery for COMP360, in anticipation of a TRD launch following NDA approval.

8. Competitive Landscape

ANKTIVA is not the comparator here — COMPASS competes in TRD, where the most relevant approved comparator is Johnson & Johnson's Spravato (esketamine nasal spray). Peer comparison (per yfinance, pulled 2026-05-26; all figures in USD). COMPASS is the only company in the table with a fully read-out, two-trial Phase 3 psilocybin program in TRD; atai Life Sciences is the most direct psychedelic-platform peer; J&J is the incumbent in interventional psychiatry.

Company	Ticker	Market cap	Revenue (TTM)	Gross margin	P/S
COMPASS Pathways plc	CMPS	$1.59bn	$0 (no commercial product)	not meaningful	not meaningful
atai Life Sciences N.V.	ATAI	$1.74bn	$0.30M	not meaningful (clinical stage)	extremely high (not meaningful)
GH Research plc	GHRS	$1.04bn	$0 (no commercial product)	not meaningful	not meaningful
Cybin Inc.	CYBN	$0.45bn	$0 (no commercial product)	not meaningful	not meaningful
Johnson & Johnson	JNJ	$564.11bn	$96.36bn	68.04%	5.85
Bristol-Myers Squibb Company	BMY	$93.97bn	$49.18bn	71.74%	1.91

Note: peer market caps and revenue figures are illustrative and sourced from yfinance pulled 2026-05-26; clinical-stage peers (ATAI, GHRS, CYBN) have no commercial revenue and sales-based multiples are not meaningful. Spravato is Johnson & Johnson's interventional antidepressant (approved in 2019 for TRD in conjunction with an oral antidepressant; per the FY2025 10-K, Item 1, filed 2026-03-24). Among psychedelic-platform peers, GH Research is developing GH001 (inhaled mebufotenin/5-MeO-DMT) and Cybin is developing CYB003 (deuterated psilocybin analogue), each at earlier development stages than COMP360. No opinion on positioning is expressed here — clinical-stage peer comparison rests primarily on trial outcomes, regulatory status and capital strength rather than current financial multiples.

9. Leadership and Ownership

Per the FY2025 10-K (Item 1 and insider transaction filings via yfinance, pulled 2026-05-26): Kabir Nath is President and Chief Executive Officer; Teri Loxam is Chief Financial Officer. Company co-founders George Goldsmith and Ekaterina Malievskaia continue to be reported as beneficial owners of more than 10% of a class of security in recent insider filings (per insider_transactions via yfinance, pulled 2026-05-26). Detailed executive tenure and proxy-level biographical information beyond these roles is not disclosed in this report's source data (the Item 10 proxy section was not in the extracted 10-K text).

Top institutional shareholders as of 2026-03-31 (per yfinance institutional_holders, pulled 2026-05-26):

Holder	% held	Shares	Value (USD)
Deep Track Capital, LP	9.01%	12,161,496	$143.6M
RTW Investments LP	7.88%	10,632,390	$125.6M
Marshall Wace LLP	2.99%	4,038,335	$47.7M
Tang Capital Management, LLC	2.97%	4,002,200	$47.3M
BIT Capital GmbH	2.59%	3,491,234	$41.2M
ARK Investment Management, LLC	2.45%	3,301,050	$39.0M
Millennium Management LLC	2.33%	3,138,522	$37.1M
GMT Capital Corp	2.28%	3,078,536	$36.4M
Two Sigma Investments, LP	1.91%	2,583,499	$30.5M
DAFNA Capital Management, LLC	1.79%	2,418,882	$28.6M

Per yfinance (pulled 2026-05-26): institutional ownership totals 72.99% and insider ownership totals 7.83%. Recent insider activity (per insider_transactions via yfinance, pulled 2026-05-26):

• 2026-03-26: CEO Kabir Nath received a 175,000-share stock-award grant at $0.00 per share (annual equity award).
• 2026-03-26: CFO Teri Loxam received a 75,000-share stock-award grant at $0.00 per share (annual equity award).
• 2024-10-24: Co-founder George Goldsmith sold 776,565 shares at $6.43 (approximately $4.99 million).
• 2024-10-24: Co-founder Ekaterina Malievskaia sold 1,553,130 shares at $6.43 (approximately $9.99 million).
• 2024-09-26: atai Life Sciences NV sold 2,660,000 shares at $6.05 (approximately $16.1 million).

10. Risks and Challenges

• No commercial product and history of significant losses (Financial): Per the FY2025 10-K (Item 1A, filed 2026-03-24): the Company has no products approved for commercial sale and has incurred net losses every year since inception; cumulative net losses of -$822.6 million had been recorded by 2025-12-31. FY2025 operating loss was -$179.0 million (EDGAR XBRL).
• Need for additional funding before potential approval (Financial): Per the FY2025 10-K (Item 1A, filed 2026-03-24): "we will need additional funding in the future to sufficiently finance our operations" — even though cash plus exercise of outstanding 2025 ADS Warrants is expected to fund operations into 2028, any delay in NDA approval, launch slip or trial expansion could pull that runway forward.
• Single-product dependence on COMP360 (Concentration): Per the FY2025 10-K (Item 1A, filed 2026-03-24): the Company's prospects are substantially dependent on the success of a single therapeutic candidate, COMP360, across TRD, PTSD and adjacent indications; any negative read-through from a Part B 26-week data point, FDA Advisory Committee, label or post-marketing data would materially impair the equity value.
• FDA approval is not guaranteed despite positive Phase 3 data (Regulatory): Per the FY2025 10-K (Item 1A, filed 2026-03-24): "even if we receive regulatory approval for COMP360 or any future therapeutic candidates," approval may be on a narrower label than sought, subject to REMS or other restrictions, or denied — the rolling NDA and CNPV do not guarantee approval.
• Psilocybin is a Schedule I controlled substance (Regulatory): Per the FY2025 10-K (Item 1A, filed 2026-03-24): COMP360 contains psilocybin, currently a Schedule I controlled substance under the US Controlled Substances Act; commercial launch requires DEA rescheduling action and ongoing controlled-substance regulatory compliance, with potential impacts from regulatory agency staffing cuts and policy changes.
• Therapy delivery operational complexity (Operational): Per the FY2025 10-K (Item 1, filed 2026-03-24): COMP360 must be administered in certified treatment centres with psychological support during a multi-hour supervised session — a delivery model that has no direct precedent in scaled oral antidepressants, creating execution risk on treatment-centre certification, training and reimbursement.
• Manufacturing dependence on contract manufacturers (Operational): Per the FY2025 10-K (Item 1A, filed 2026-03-24): the Company depends on third-party manufacturers for the supply of COMP360 GMP material; any disruption, delay or quality issue at a CMO could delay clinical trials or commercial launch.
• Reimbursement and post-approval promotional limits (Market & Demand): Per the FY2025 10-K (Item 1A, filed 2026-03-24): "we may be subject to limitations on how we may promote the therapeutic candidate; sales of the COMP360 psilocybin treatment may decrease significantly" if reimbursement is restricted or labelling is narrow, even after FDA approval.
• Competitive risk from Spravato and other emerging psychedelic/IO therapies (Competitive): Per the FY2025 10-K (Item 1, filed 2026-03-24): Spravato (esketamine, J&J) has been approved by the FDA for TRD since 2019, and other psychedelic and rapid-acting antidepressant developers (atai, GH Research, Cybin and others) are advancing competing programs.
• Cybersecurity and personal data risk (Cyber & Physical): Per the FY2025 10-K (Item 1C / Item 1A, filed 2026-03-24): the Company is "subject to health information privacy regulation by both the federal government and the states in which we conduct our business," and a cyberattack or data breach could expose the Company to fines, litigation and reputational harm.
• Concentrated specialist-fund ownership and warrant overhang (Concentration): Per yfinance institutional_holders (pulled 2026-05-26) and the Q1 2026 10-Q (filed 2026-05-13): institutional ownership is 72.99% with the top two holders (Deep Track 9.01%, RTW 7.88%) alone holding ~17% of the float; outstanding 2025 ADS Warrants and PIPE warrants represent a non-trivial additional dilution and earnings-volatility source if exercised or remeasured.

11. Recent Developments

Most recent first.

• 2026-05-19 — Compass participates in RBC Capital Markets Global Healthcare Conference: Management held a fireside chat at 10:00 a.m. ET on 2026-05-19 at the RBC Global Healthcare Conference, with a live audio webcast available on the Investors section of the Compass Pathways website. Source: Compass Pathways press release, 2026-05-14.
• 2026-05-17 — Buy consensus on CMPS (reported factually): Aggregated analyst coverage records a "Buy" consensus rating on CMPS as of 2026-05-17 (per public.com analyst-action summary). Reported here for completeness; ChartsView does not endorse this rating. Source: public.com analyst forecast.
• 2026-05-13 — Q1 2026 results: $466.0M cash, rolling NDA underway, NDA Q4 2026: Q1 2026 GAAP loss from operations was -$42.9 million, but GAAP net income was +$91.2 million owing to a +$130.9 million non-cash fair-value gain on warrant liabilities; diluted EPS -$0.30 (a $0.09 beat to the consensus -$0.39 estimate). Cash and cash equivalents were $466.0 million at 2026-03-31, providing runway into 2028. 26-week Part B data from COMP006 is expected in early Q3 2026 and final NDA submission in Q4 2026, with launch-readiness targeted for year-end. Source: Compass Pathways Q1 2026 8-K Exhibit 99.1.
• 2026-04-28 — HC Wainwright sets $70 price target (reported factually): HC Wainwright & Co. published a $70 price target on CMPS, reported in aggregated analyst-action coverage as the high target across the analyst universe. Reported here for completeness; ChartsView does not endorse this target. Source: public.com analyst forecast.

COMPASS Pathways' official X (Twitter) handle is @compasspathways. No additional independently link-verifiable X posts from the company, CEO or CFO within the 30-day window are included in this report's source data.

12. Key Dates Coming Up

• 2026-05-27 — 2026 Annual General Meeting of Stockholders: Held at 1:30 p.m. London / 8:30 a.m. ET at the offices of Goodwin Procter (UK) LLP, Sancroft, 10-15 Newgate Street, London EC1A 7AZ; record date for ADS holders was 2026-04-06 (per the DEF 14A proxy statement filed 2026-04-15).
• Early Q3 2026 — COMP006 26-week (Part B) data readout: Compass expects to report 26-week data from the pivotal COMP006 trial in early third quarter 2026 (per the Q1 2026 earnings release, 2026-05-13).
• Q4 2026 — Final NDA submission for COMP360 in TRD: Final NDA submission targeted for the fourth quarter of 2026, with the rolling NDA structure allowing modules to be filed as completed (per the Q1 2026 earnings release, 2026-05-13).
• Within 1–2 months of final NDA submission — Potential CNPV-accelerated FDA review: The Commissioner's National Priority Voucher awarded 2026-04-24 may enable a 1–2 month FDA review window after final NDA filing, subject to FDA's standard safety and efficacy review (per Compass Pathways, 2026-04-24).
• Q2 2026 earnings — date not disclosed in this report's source data: Q1 2026 was reported on 2026-05-13 (per the Q1 2026 8-K).

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Risk Warning: This research is for information only and is not investment advice or a recommendation to buy or sell any security. CFD Risk Warning: CFDs are complex instruments and come with a high risk of losing money rapidly due to leverage. Between 74–89% of retail investor accounts lose money when trading CFDs. Affiliate Disclosure: We may receive a commission from some links on this page at no extra cost to you. Data Disclaimer: All figures are sourced from company filings, earnings releases, and public market data as at the date above. Forward-looking statements are attributed to the company and may not be achieved. Always do your own research. Generated by ChartsView research tooling. Thesis strength measures how well the evidence in this report supports the company's stated thesis — it is NOT a buy/sell rating or price target. ChartsView is not authorised by the FCA to provide regulated investment advice.

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage immunotherapy company headquartered in San Diego, California, whose lead product ANKTIVA (nogapendekin alfa inbakicept-pmln) is an IL-15 receptor superagonist approved by the FDA in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors (per the FY2025 10-K, Item 1, filed 2026-02-23). For the year ended December 31, 2025 the Company reported total revenue of $113.3 million, up 668% year over year, with ANKTIVA net product revenue of $113.0 million up approximately 698% (per the FY2025 10-K, Item 7, filed 2026-02-23); an operating loss of -$256.0 million (per EDGAR XBRL OperatingIncomeLoss, 10-K period ending 2025-12-31); a net loss of -$351.4 million (per the FY2025 10-K, Item 7); and free cash flow of -$309.2 million (per yfinance annual cashflow, FY2025). The stock last traded at $7.22 against a 52-week range of $1.95 to $12.43 (per yfinance, pulled 2026-05-24), and the most recent earnings release was Q1 2026 on 2026-05-07, with the next (Q2 2026) date not disclosed in this report's source data. The Company employed 691 people as of 2025-12-31 (per the FY2025 10-K, Item 1, filed 2026-02-23).

1. Company Snapshot

Field	Value
Name	ImmunityBio, Inc. (per the FY2025 10-K, cover page, filed 2026-02-23)
Ticker / Exchange	IBRX / Nasdaq Global Select Market (per the FY2025 10-K, cover page)
Sector / Industry	Healthcare / Biotechnology (per yfinance, pulled 2026-05-24)
Market cap	$7.56bn (per yfinance, 2026-05-24)
Enterprise value	$8.31bn (per yfinance, 2026-05-24)
FY2025 revenue	$113.3M total; ANKTIVA net product revenue $113.0M (per the FY2025 10-K, Item 7, filed 2026-02-23)
FY2025 operating income (EDGAR XBRL)	-$256.0M (per EDGAR XBRL OperatingIncomeLoss, 10-K period ending 2025-12-31)
FY2025 free cash flow	-$309.2M (per yfinance annual cashflow, FY2025)
Gross margin (FY2025)	99.3% (cost of sales $0.8M on product revenue $113.0M, per the FY2025 10-K, Item 7)
Net margin (FY2025)	-310% (net loss -$351.4M on revenue $113.3M, per the FY2025 10-K, Item 7)
Employees	691 (per the FY2025 10-K, Item 1, Human Capital, as of 2025-12-31)
CEO	Richard Adcock, President & CEO (per the Q1 2026 earnings release, 2026-05-07; founder Patrick Soon-Shiong is Executive Chairman)
Headquarters	San Diego, California (per the FY2025 10-K, principal executive offices, filed 2026-02-23)
Website	immunitybio.com (per yfinance, pulled 2026-05-24)
Fiscal year-end	December 31 (per the FY2025 10-K, filed 2026-02-23)
Next earnings	Q2 2026 (Q1 2026 reported 2026-05-07 per yfinance earningsTimestamp; the next report date is not disclosed in this report's source data)
Dividend yield	None — ImmunityBio has never declared a dividend (per yfinance, pulled 2026-05-24; the FY2025 10-K)
52-week high	$12.43 (per yfinance, pulled 2026-05-24)
52-week low	$1.95 (per yfinance, pulled 2026-05-24)
Short interest	35.56% of float (per yfinance shortPercentOfFloat, pulled 2026-05-24)

2. Bull Case vs Bear Case

Bull Case

• ANKTIVA commercial ramp is steep and consistent. Per the FY2025 10-K (Item 7, filed 2026-02-23): ANKTIVA net product revenue reached $113.0 million in FY2025, an approximately 698% increase year over year, and total revenue rose 668% to $113.3 million. Per the Q1 2026 earnings release (2026-05-07): Q1 2026 net product revenue was $44.2 million, up approximately 168% year over year and up 15% sequentially from Q4 2025's $38.3 million, with net product revenue growth in every quarter since ANKTIVA's commercial launch in May 2024.
• Regulatory momentum is broadening the addressable label. Per the Q1 2026 earnings release (2026-05-07): the NCCN Clinical Practice Guidelines were updated to include ANKTIVA plus BCG for BCG-unresponsive NMIBC with papillary-only disease (Category 2A), in addition to CIS. Per ImmunityBio's announcement (2026-05-19): the FDA accepted a supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC, with a PDUFA target action date of January 6, 2027.
• International approvals and a second indication are being secured. Per the Q1 2026 earnings release (2026-05-07): ANKTIVA is now approved or authorized across five regulatory jurisdictions representing approximately 34 countries, including the first approval in Asia by the Macau Special Administrative Region. Per the FY2025 10-K (Item 1, filed 2026-02-23): ANKTIVA received conditional approval from the Saudi SFDA in combination with a checkpoint inhibitor for metastatic NSCLC — described by the Company as the first regulatory approval for an IL-15 receptor superagonist in lung cancer.
• Strong gross margin on the approved product. Per the FY2025 10-K (Item 7, filed 2026-02-23): cost of sales was $0.8 million against product revenue of $113.0 million, a product gross margin of approximately 99.3% — a structurally high-margin profile once volume scales relative to fixed operating costs.
• Intellectual property and supply security are being reinforced. Per ImmunityBio's announcement (2026-05-18): five U.S. patents were issued covering the ANKTIVA-plus-BCG combination with terms extending through at least 2035. Per ImmunityBio's announcement (2026-05-16): the Company signed an exclusive U.S. agreement with Japan BCG Laboratory for the Tokyo strain of BCG, adding a second potential BCG source alongside its Serum Institute of India recombinant-BCG partnership to address the chronic U.S. BCG shortage.

Bear Case

• Deeply negative profitability and a going-concern warning. Per the FY2025 10-K (Item 7, filed 2026-02-23): operating loss was -$256.0 million (EDGAR XBRL OperatingIncomeLoss confirms -$256,027,000) and net loss was -$351.4 million in FY2025. The Company states: "we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support" (per the FY2025 10-K, Item 7).
• Accumulated deficit of $3.7 billion and persistent cash burn. Per the FY2025 10-K (Item 1A, filed 2026-02-23): "we have incurred significant losses each year, and, as of December 31, 2025, we had an accumulated deficit of $3.7 billion." Free cash flow was -$309.2 million in FY2025 (per yfinance annual cashflow, FY2025), and the accumulated deficit rose to $4.4 billion by 2026-03-31 (per the Q1 2026 earnings release, 2026-05-07).
• Severe historical dilution. Per the FY2025 10-K (balance sheet, filed 2026-02-23) and yfinance: shares outstanding grew from 421.6 million at FY2022 year-end to 1,011.8 million at FY2025 year-end, and stood at approximately 1,047.4 million as of 2026-05-24 (per yfinance) — roughly a 2.5x increase over three years to fund operations.
• Single-product, single-region revenue concentration. Per the FY2025 10-K (Item 1A, filed 2026-02-23): "We are substantially dependent on the successful commercialization of our approved product and the success and regulatory approval of our other product candidates." Per the FY2025 10-K (Item 7): four customers accounted for 42%, 19%, 18% and 17% of total revenue, respectively, and product revenue to date has been generated in the United States.
• Controlled-company governance and related-party financing. Per the FY2025 10-K (Item 1A, filed 2026-02-23): "Dr. Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval." A $505.0 million December 2024 convertible promissory note is held by an entity affiliated with Dr. Soon-Shiong (carried at $477.1 million fair value at FY2025), and the Company also carries a $324.6 million revenue interest liability with Oberland (per the FY2025 10-K, Notes 13 and 14, filed 2026-02-23).

3. What Does ImmunityBio Actually Do?

ImmunityBio operates as a single commercial-stage immunotherapy business built around its Cancer BioShield platform, anchored by ANKTIVA (per the FY2025 10-K, Item 1, filed 2026-02-23). Substantially all of its revenue is ANKTIVA net product revenue.

Revenue line	FY2025	FY2024	YoY
Product revenue, net (ANKTIVA)	$112.982M	$14.150M	+698%
Other revenues	$0.306M	$0.595M	-49%
Total revenue	$113.288M	$14.745M	+668%

Source: the FY2025 10-K, Item 7, filed 2026-02-23.

In plain English, ANKTIVA is an antibody-cytokine fusion protein (an IL-15 receptor superagonist) that is instilled into the bladder together with BCG to stimulate natural killer (NK) cells, cytotoxic T cells and memory T cells — the body's own immune machinery — to clear bladder tumours without removing the bladder (per the FY2025 10-K, Item 1, filed 2026-02-23). The approved use is BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumours; commercial distribution began in May 2024 following FDA approval (per the FY2025 10-K, Item 1).

Geographically, product revenue to date has been earned in the United States, with international commercialisation beginning to contribute as ANKTIVA reaches five jurisdictions (~34 countries) including Saudi Arabia and Macau (per the Q1 2026 earnings release, 2026-05-07). A segment-level or geographic revenue breakdown beyond the product/other split above is not disclosed in this report's source data, as the Company reports as a single operating segment (per the FY2025 10-K, Item 7, filed 2026-02-23).

4. The Business Model

Per the FY2025 10-K (Item 1, filed 2026-02-23): ImmunityBio's model is to develop and commercialise next-generation immunotherapies that activate both the innate and adaptive immune systems. Today the revenue engine is a single approved biologic — ANKTIVA — sold in the United States to a concentrated set of specialty distributors and administered by urologists in combination with BCG. The economics are characteristic of a recently launched, high-gross-margin biologic: product gross margin was approximately 99.3% in FY2025 (cost of sales $0.8 million on product revenue $113.0 million, per the FY2025 10-K, Item 7), but the business is loss-making because research and development and selling, general and administrative spend vastly exceed gross profit.

The moat the Company describes rests on three pillars (per the FY2025 10-K, Item 1, filed 2026-02-23 and ImmunityBio's 2026-05-18 patent announcement): first, intellectual property — Dr. Soon-Shiong holds over 400 issued patents, and five U.S. patents covering the ANKTIVA-plus-BCG combination run through at least 2035; second, a proprietary IL-15 superagonist mechanism and an integrated manufacturing base (including a facility in Dunkirk, New York); and third, control of the BCG supply chain that ANKTIVA depends on, via partnerships with the Serum Institute of India (recombinant BCG) and Japan BCG Laboratory (Tokyo strain BCG).

A defining structural feature of the model is its reliance on related-party and structured financing rather than operating cash flow. Per the FY2025 10-K (Notes 13 and 14, filed 2026-02-23): the Company is funded in part by a $505.0 million convertible promissory note held by an entity affiliated with its Executive Chairman and by a revenue interest liability with Oberland under a Revenue Interest Purchase Agreement (RIPA), under which a percentage of ANKTIVA net sales in the covered territory is payable to Oberland.

5. Financial Health

5-year income trend (per the FY2025 10-K Item 7 and yfinance annual financials; FY2021 not in source data):

FY	Revenue	Operating income	Net income	Diluted EPS	Free cash flow
FY2025	$113.3M	-$256.0M (EDGAR XBRL)	-$351.4M	-$0.38	-$309.2M
FY2024	$14.7M	-$344.2M	-$413.6M	-$0.62	-$398.1M
FY2023	$0.6M	-$361.4M	-$583.2M	-$1.15	-$397.3M
FY2022	$0.2M	-$350.6M	-$416.6M	-$1.04	-$436.9M
FY2021	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data	not disclosed in this report's source data

Per the FY2025 10-K (Item 7, filed 2026-02-23): the leap from $14.7 million of FY2024 revenue to $113.3 million in FY2025 reflects the first full year of ANKTIVA commercial sales. Operating loss narrowed from -$344.2 million to -$256.0 million as gross profit scaled, even though research and development plus selling, general and administrative expense remained the dominant cost base.

Balance sheet (per the FY2025 10-K, balance sheet, filed 2026-02-23 and yfinance annual balance sheet):

FY	Cash & equivalents	Total debt	Stockholders' equity (deficit)	Shares outstanding	Buybacks
FY2025	$88.3M (cash); $242.8M incl. marketable securities	$518.1M	-$500.5M	1,011.8M	$0
FY2024	$143.4M	$504.2M	-$489.1M	852.9M	$0
FY2023	$265.5M	$726.7M	-$587.0M	670.9M	$0
FY2022	$104.6M	$723.8M	-$447.3M	421.6M	$0

Per the FY2025 10-K (Notes 13 and 14, filed 2026-02-23): the principal debt instruments are the related-party convertible promissory note (carried at $477.1 million fair value at FY2025, up from $461.9 million at FY2024) and the Oberland revenue interest liability ($324.6 million at FY2025, up from $284.4 million at FY2024). The Company has a stockholders' deficit, so book equity is negative; the FY2025 retained-earnings (accumulated deficit) balance was -$3.73 billion.

Quarterly trend, last 5 quarters (per yfinance quarterly financials and the Q1 2026 earnings release, periods ending Q1 2025 through Q1 2026):

Quarter	Revenue	Gross profit	Operating income	Net income	Diluted EPS	Free cash flow
Q1 2026 (2026-03-31)	$44.2M	$44.0M	-$69.8M	-$632.8M	-$0.62	not disclosed in this report's source data (operating cash flow -$75.4M)
Q4 2025 (2025-12-31)	$38.3M	$37.9M	-$64.7M	-$61.9M	-$0.06	not disclosed in this report's source data
Q3 2025 (2025-09-30)	$32.1M	$31.9M	-$55.6M	-$67.3M	-$0.07	not disclosed in this report's source data
Q2 2025 (2025-06-30)	$26.4M	$26.3M	-$71.3M	-$92.6M	-$0.10	not disclosed in this report's source data
Q1 2025 (2025-03-31)	$16.5M	$16.5M	-$64.4M	-$129.6M	-$0.15	not disclosed in this report's source data

Revenue has risen every quarter since launch. The Q1 2026 net loss of -$632.8 million is far larger than the -$69.8 million operating loss because of a -$530.9 million non-cash change in the fair value of warrant and derivative liabilities and the related-party convertible note — driven by the significant increase in the Company's common-stock price during the quarter — plus a $7.4 million write-off of a convertible note receivable (per the Q1 2026 earnings release, 2026-05-07). On that basis the Company reported a non-GAAP adjusted net loss of -$86.2 million for Q1 2026 (per the Q1 2026 earnings release, 2026-05-07).

6. Valuation & Market Data

Raw market data only — no commentary on cheap or expensive.

Metric	Value
Share price	$7.22 (per yfinance, pulled 2026-05-24)
Previous close	$7.74 (per yfinance, pulled 2026-05-24)
Day range	$7.15 – $7.69 (per yfinance, pulled 2026-05-24)
52-week high / low	$12.43 / $1.95 (per yfinance, pulled 2026-05-24)
Market cap	$7.56bn (per yfinance, pulled 2026-05-24)
Enterprise value	$8.31bn (per yfinance, pulled 2026-05-24)
Shares outstanding	1,047.4M (per yfinance; 1,011,800,008 reported at 2025-12-31 in the FY2025 10-K)
Float	394.0M (per yfinance, pulled 2026-05-24)
Avg daily volume (10d)	15.10M (per yfinance averageVolume10days, pulled 2026-05-24)
Volume (latest)	17.94M (per yfinance, pulled 2026-05-24)
Beta	0.07 (per yfinance, pulled 2026-05-24)
Trailing P/E (GAAP)	not disclosed in this report's source data — net loss in TTM (per yfinance, pulled 2026-05-24)
Forward P/E	68.76 (per yfinance, pulled 2026-05-24)
P/S (TTM)	53.64 (per yfinance, pulled 2026-05-24)
P/B	-8.69 (negative — stockholders' deficit; per yfinance, pulled 2026-05-24)
EV / Revenue	58.92 (per yfinance, pulled 2026-05-24)
EV / EBITDA	-33.85 (per yfinance, pulled 2026-05-24)
P / FCF	not disclosed in this report's source data — FCF negative (per yfinance, pulled 2026-05-24)
Gross margin (TTM)	99.34% (per yfinance, pulled 2026-05-24)
Operating margin (TTM GAAP)	-157.88% (per yfinance, pulled 2026-05-24)
Net margin (TTM)	not meaningful — TTM net loss distorted by large non-cash fair-value charges (per yfinance, pulled 2026-05-24)
ROE	not disclosed in this report's source data — negative equity (per yfinance, pulled 2026-05-24)
ROA	-34.38% (per yfinance, pulled 2026-05-24)
Debt-to-equity	not disclosed in this report's source data — negative equity (per yfinance, pulled 2026-05-24)
Current ratio	6.67 (per yfinance, pulled 2026-05-24)
Dividend yield	None — Company has never paid a dividend (per yfinance, pulled 2026-05-24)
Short interest	35.56% of float (per yfinance shortPercentOfFloat, pulled 2026-05-24)
Put / call ratio	not disclosed in this report's source data

7. What Are They Building / What's Coming

Per the FY2025 10-K (Item 1, filed 2026-02-23), the Q1 2026 earnings release (2026-05-07) and named public announcements, ImmunityBio's near-term pipeline and initiatives include:

• BCG-unresponsive papillary-only NMIBC (sBLA under FDA review). Per ImmunityBio's announcement (2026-05-19): the FDA accepted a supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC, with a PDUFA target action date of January 6, 2027 — potentially the first FDA-approved bladder-sparing option specifically for that population.
• BCG-naïve NMIBC (QUILT-2.005, sBLA planned 2026). Per the Q1 2026 earnings release (2026-05-07): the pivotal BCG-naïve CIS trial is fully enrolled, the Independent Data Monitoring Committee confirmed no additional enrollment is required, and a supplemental BLA submission is on track for 2026.
• Non-small cell lung cancer (NSCLC) + checkpoint inhibitor. Per ImmunityBio's announcement (2026-01-13): ANKTIVA plus CPI showed statistically significant immune restoration across two trials in 151 NSCLC patients, with responders in the later-line study (QUILT-3.055) showing longer median overall survival (16.2 vs 11.8 months; HR 0.52; p=0.0369). ANKTIVA is conditionally approved with CPIs for metastatic NSCLC in Saudi Arabia (per the FY2025 10-K, Item 1, filed 2026-02-23).
• Lymphopenia (tumour-agnostic) and cell-therapy programs. Per the FY2025 10-K (Item 1, filed 2026-02-23): the Company is pursuing ANKTIVA for chemotherapy/radiation-induced lymphopenia and is advancing NK-cell platforms, including PD-L1 t-haNK (a CAR-NK therapy that has received FDA RMAT designation) in indications such as glioblastoma, plus CD19-targeted therapies in non-Hodgkin lymphoma and Waldenström's macroglobulinemia (per the Q1 2026 earnings release, 2026-05-07).
• BCG supply security. Per ImmunityBio's announcement (2026-05-16): the exclusive U.S. agreement with Japan BCG Laboratory for the Tokyo strain of BCG, supported by the NCI-sponsored SWOG S1602 Phase III non-inferiority readout, positions the Company as sole U.S. BLA applicant for that strain, complementing its Serum Institute of India recombinant-BCG Expanded Access Program.

8. Competitive Landscape

ImmunityBio competes in non-muscle invasive bladder cancer against both clinical-stage developers and large-cap pharmaceutical companies. Peer comparison (per yfinance, pulled 2026-05-24; all figures in USD). ImmunityBio is the only company in the table with an FDA-approved, commercially marketed IL-15 immunotherapy for NMIBC; CG Oncology, enGene and Protara are clinical / early-commercial developers for which sales-based multiples are not meaningful.

Company	Ticker	Market cap	Revenue (TTM)	Gross margin	P/S
ImmunityBio, Inc.	IBRX	$7.56bn	$141.0M	99.34%	53.64
CG Oncology, Inc.	CGON	$5.67bn	$5.1M	not meaningful (clinical stage)	not meaningful
enGene Holdings Inc.	ENGN	$109.9M	not disclosed in this report's source data	not meaningful (clinical stage)	not meaningful
Protara Therapeutics, Inc.	TARA	$276.5M	not disclosed in this report's source data	not meaningful (clinical stage)	not meaningful
Merck & Co., Inc.	MRK	$302.33bn	$65.77bn	76.73%	4.60
Johnson & Johnson	JNJ	$564.11bn	$96.36bn	68.04%	5.85

Positioning, per public disclosures: CG Oncology (cretostimogene), enGene (detalimogene) and Protara (TARA-002) are advancing competing NMIBC candidates; Merck markets Keytruda in NMIBC; and Johnson & Johnson's TAR-200 is an intravesical competitor — the same comparator ImmunityBio used in its 2026-05-22 ISPOR health-economic analysis. The large-cap peers dwarf ImmunityBio in revenue and balance-sheet resources, while ImmunityBio's differentiation is being the first marketed IL-15 receptor superagonist with an approved bladder-cancer indication.

9. Leadership and Ownership

Per the FY2025 10-K (Item 1, filed 2026-02-23), the Q1 2026 earnings release (2026-05-07) and insider transaction filings via yfinance (pulled 2026-05-24): Patrick Soon-Shiong, M.D. is Founder, Executive Chairman and Global Chief Scientific and Medical Officer; he is a physician-scientist who holds over 400 issued patents and is the Company's controlling shareholder. Richard Adcock is President and Chief Executive Officer; David C. Sachs is Chief Financial Officer; Barry J. Simon, M.D. and Christobel E. Selecky serve as Directors. Detailed executive tenure and proxy-level biographical information beyond these roles is not disclosed in this report's source data (the Item 10 proxy section was not in the extracted 10-K text).

Top institutional shareholders as of 2026-03-31 (per yfinance institutional_holders, pulled 2026-05-24):

Holder	% held	Shares	Value (USD)
BlackRock Inc.	2.52%	26,346,443	$190.2M
State Street Corporation	1.69%	17,708,103	$127.9M
Vanguard Portfolio Management LLC	1.56%	16,322,844	$117.9M
Vanguard Capital Management LLC	1.44%	15,127,714	$109.2M
D. E. Shaw & Co., Inc.	1.20%	12,571,597	$90.8M
Geode Capital Management, LLC	0.77%	8,031,921	$58.0M
Two Sigma Investments, LP	0.42%	4,385,500	$31.7M
Morgan Stanley	0.38%	4,018,869	$29.0M
HRT Financial LP	0.37%	3,925,446	$28.3M
Woodline Partners LP	0.33%	3,447,346	$24.9M

Per yfinance (pulled 2026-05-24): institutional ownership totals 17.54% and insider ownership totals 62.48%, the latter reflecting Dr. Soon-Shiong's controlling stake. Recent insider activity (per insider_transactions via yfinance, pulled 2026-05-24):

• 2026-03-31: Dr. Patrick Soon-Shiong acquired 4,606,596 shares via conversion/exercise of a derivative security at $5.43 ($25.0 million).
• 2026-02-23 to 2026-02-24: Director Barry J. Simon sold a combined 250,000 shares at $9.25–$12.01 (approximately $2.68 million).
• 2026-02-23: Director Christobel E. Selecky sold 25,000 shares at $10.00 ($250,000) and converted 25,000 shares at $2.98.

10. Risks and Challenges

• Going concern / dependence on additional financing (Financial): Per the FY2025 10-K (Item 7, filed 2026-02-23): "we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support." The Company anticipates needing additional financing to fund operations, complete commercialisation and conduct clinical trials.
• History of losses and large accumulated deficit (Financial): Per the FY2025 10-K (Item 1A, filed 2026-02-23): "we have incurred significant losses each year, and, as of December 31, 2025, we had an accumulated deficit of $3.7 billion." FY2025 operating loss was -$256.0 million (EDGAR XBRL).
• Substantial dilution from equity issuance (Financial): Per the FY2025 10-K (Item 1A, filed 2026-02-23): additional equity or convertible issuance may "dilute the ownership interest of existing stockholders or may otherwise depress the price of our common stock." Shares outstanding rose from 421.6 million (FY2022) to 1,011.8 million (FY2025).
• Single-product, single-region revenue concentration (Concentration): Per the FY2025 10-K (Item 1A, filed 2026-02-23): "We are substantially dependent on the successful commercialization of our approved product and the success and regulatory approval of our other product candidates." Per the FY2025 10-K (Item 7): four customers accounted for 42%, 19%, 18% and 17% of total revenue.
• Dependence on BCG supply (Operational): Per the FY2025 10-K (Item 1, filed 2026-02-23): ANKTIVA is approved for use with BCG, and "currently TICE BCG is the only FDA-approved strain of BCG available in the U[S]" amid a chronic, decade-long U.S. BCG shortage — a direct constraint on ANKTIVA utilisation that the Serum Institute and Japan BCG Laboratory agreements are intended to mitigate.
• Controlled-company governance and related-party financing (Concentration): Per the FY2025 10-K (Item 1A, filed 2026-02-23): "Dr. Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval," and he holds a controlling interest in affiliated entities that provide the Company's $505.0 million convertible note and lease its manufacturing facilities.
• Manufacturing and quality compliance (Operational): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the Company is subject to obligations regarding its manufacturing facility in Dunkirk, New York, and manufacturers "must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP" — failure could materially impair supply.
• Promotional and regulatory compliance (Regulatory): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the promotion and marketing of biologics is heavily regulated; ImmunityBio publicly responded to an FDA Office of Prescription Drug Promotion (OPDP) matter regarding ANKTIVA promotional materials in April 2026 (per ImmunityBio's 2026-04-06 statement), underscoring the compliance risk around marketing claims.
• Litigation and intellectual-property disputes (Competitive): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the Company may be "subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents," which could be costly and divert resources.
• Cybersecurity incidents (Cyber & Physical): Per the FY2025 10-K (Item 1C / Item 1A, filed 2026-02-23): the Company could "suffer a cyberattack, security breach or other incident," including compromise of confidentiality, integrity and availability of its systems, with potential material adverse effects.
• Clinical and regulatory approval risk for the pipeline (Regulatory): Per the FY2025 10-K (Item 1A, filed 2026-02-23): the Company's product candidates are investigational and there can be no assurance that label expansions (such as the papillary-only and BCG-naïve sBLAs) or new indications (such as NSCLC) will be approved by the FDA or other regulators.

11. Recent Developments

Most recent first.

• 2026-05-22 — ISPOR 2026 health-economic analysis published: ImmunityBio presented a health-economic analysis indicating ANKTIVA plus BCG delivered a lower cost per sustained complete responder than Johnson & Johnson's TAR-200 in BCG-unresponsive NMIBC CIS, with reported savings of up to ~$151,438 per cystectomy avoided over three years in a U.S. Medicare population. Source: ImmunityBio / Business Wire.
• 2026-05-19 — FDA accepts papillary-only sBLA; PDUFA January 6, 2027: The FDA accepted for review the supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC (without CIS) and set a PDUFA target action date of January 6, 2027. Source: ImmunityBio.
• 2026-05-18 — Five U.S. patents issued for ANKTIVA + BCG: Five U.S. patents covering the ANKTIVA-plus-BCG combination were issued with terms extending through at least 2035, protecting the combination, dosing regimen and two-vial commercial kit. Source: ImmunityBio / Yahoo Finance.
• 2026-05-16 — Exclusive U.S. agreement with Japan BCG Laboratory (Tokyo strain): ImmunityBio signed an exclusive U.S. development and supply agreement for the Tokyo strain of BCG, supported by the NCI-sponsored SWOG S1602 Phase III non-inferiority readout, becoming sole U.S. BLA applicant for that strain; announced during Dr. Soon-Shiong's AUA 2026 presentation in Washington, DC. Source: ImmunityBio 8-K Exhibit 99.1.
• 2026-05-07 — Q1 2026 results: record revenue, large non-cash net loss: Q1 2026 net product revenue was $44.2 million (+168% YoY, +15% QoQ); cash, cash equivalents and marketable securities were $380.9 million; GAAP net loss was -$632.8 million (driven by a -$530.9 million non-cash fair-value remeasurement of warrants, derivatives and the related-party convertible note) and adjusted net loss was -$86.2 million. Source: ImmunityBio 8-K Exhibit 99.1.
• 2026-05-05 — Analyst action (reported factually): D. Boral Capital set a price target of $23.00 on IBRX (per analyst-action coverage). Reported here for completeness; ChartsView does not endorse this target. Source: public.com analyst forecast.

ImmunityBio's official X (Twitter) handle is @ImmunityBio and Executive Chairman Patrick Soon-Shiong posts as @DrPatSoonShiong; his public X commentary in the period centred on the U.S. BCG shortage and papillary bladder cancer ahead of AUA 2026, consistent with the 2026-05-16 Japan BCG Laboratory announcement above. No additional X posts with independently verifiable per-post links are included in this report's source data.

12. Key Dates Coming Up

• 2026-06-09 — 2026 Annual Meeting of Stockholders: Held virtually at 10:30 a.m. Pacific Time; Notice of Internet Availability mailed on or about 2026-04-30 (per the DEF 14A proxy statement filed 2026-04-29).
• 2026 (second half) — BCG-naïve NMIBC sBLA submission: A supplemental BLA submission for the BCG-naïve setting is on track for 2026, following full enrollment of QUILT-2.005 (per the Q1 2026 earnings release, 2026-05-07).
• 2027-01-06 — PDUFA target action date (papillary-only NMIBC sBLA): FDA decision target for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC (per ImmunityBio's 2026-05-19 announcement).
• Tokyo strain BCG — FDA engagement / BLA timing: ImmunityBio plans to engage the FDA on the regulatory pathway for the Tokyo strain of BCG; specific submission timing is not disclosed in this report's source data (per the 2026-05-16 Japan BCG Laboratory announcement).
• Q2 2026 earnings — date not disclosed in this report's source data: Q1 2026 was reported on 2026-05-07 (per yfinance earningsTimestamp); the Q2 release date has not been published in the source data used for this report.

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Risk Warning: This research is for information only and is not investment advice or a recommendation to buy or sell any security. CFD Risk Warning: CFDs are complex instruments and come with a high risk of losing money rapidly due to leverage. Between 74–89% of retail investor accounts lose money when trading CFDs. Affiliate Disclosure: We may receive a commission from some links on this page at no extra cost to you. Data Disclaimer: All figures are sourced from company filings, earnings releases, and public market data as at the date above. Forward-looking statements are attributed to the company and may not be achieved. Always do your own research. Generated by ChartsView research tooling. Thesis strength measures how well the evidence in this report supports the company's stated thesis — it is NOT a buy/sell rating or price target. ChartsView is not authorised by the FCA to provide regulated investment advice.

Last Updated: 16 May 2026

Perspective Therapeutics, Inc. (NYSE American: CATX) is a Seattle-based radiopharmaceutical development company pioneering precision targeted alpha therapy (TAT) for cancer treatment. The company is building a proprietary platform centred on lead-212 (²¹²Pb), an alpha-emitting isotope that delivers high-energy, short-range radiation directly to cancer cells. Its lead programme, VMT-α-NET, is advancing through Phase 1/2a clinical trials targeting somatostatin receptor 2-positive neuroendocrine tumours, with a registration-enabling trial pathway under active regulatory discussion. With three clinical-stage programmes, a proprietary radioisotope generator, and $271 million in cash following a February 2026 equity offering, the company is among the few pure-play targeted alpha therapy developers listed on a US exchange.

1. Company Snapshot

Field	Value
Full name	Perspective Therapeutics, Inc.
Ticker	CATX
Exchange	NYSE American (AMEX)
Sector / Industry	Healthcare — Radiopharmaceuticals / Biotechnology
Founded	2004 (as Isoray, Inc.); rebranded February 2022; merged with Viewpoint Molecular Targeting February 2023
Headquarters	Seattle, Washington, USA
CEO	Thijs (Johan) Spoor (appointed February 2023)
Employees	~166 (as of April 2026; per company filings)
Market cap	~$434M (at ~$3.81/share, 114M shares; May 2026)
Revenue (FY2025)	$0.9M (NIH grant revenue; company is pre-commercial)
Net loss (FY2025)	$(103.1M) GAAP (per FY2025 press release, March 2026)
Cash & investments	$271M (Q1 2026 end, per Q1 2026 press release, May 2026)
Cash runway	Into late 2027 (per management guidance)
Website	perspectivetherapeutics.com

2. Bull Case vs Bear Case

Distilled from the full report below — factual only, no ratings.

Bull Case

• Alpha advantage over approved beta therapies: ²¹²Pb emits alpha particles with ~100× greater linear energy transfer than beta emitters such as Lu-177. Alpha particles travel only 2–10 cell diameters, delivering concentrated lethal doses while sparing surrounding tissue. No approved ²¹²Pb drug exists, placing Perspective in first-mover position in this specific modality.
• VMT-α-NET clinical momentum: At AACR April 2026, updated data showed 43% objective response rate in Cohort 2 evaluable patients; by late 2026, all 46 Cohort 2 patients will have had 60 weeks of follow-up. Sanofi discontinued its competing SSTR2-targeted alpha agent Alphamedix in 2025, leaving Perspective as the only ²¹²Pb programme in this indication.
• Extended cash runway post-offering: The February 2026 offering raised approximately $164M net, bringing cash and investments to $271M as of 31 March 2026. Management states this is sufficient to fund operations into late 2027, covering key VMT-α-NET regulatory milestones and data readouts across all three programmes.
• Proprietary manufacturing moat: The company’s ²²⁴Ra/²¹²Pb generator platform is a structural differentiator — difficult and capital-intensive for competitors to replicate. A regional supply network is under construction (Chicago flagship completing 2026; LA site in development) to enable ready-to-administer clinical and commercial supply.
• Multi-programme optionality: Three Phase 1/2a programmes (VMT-α-NET NETs, VMT01 melanoma, PSV359 FAP+ solid tumours) plus first-in-human imaging data for PSV594 (CCK2R-targeted) presented May 2026 diversify binary clinical risk.

Bear Case

• Clinical-stage binary risk: All three programmes remain in Phase 1/2a. No product has regulatory approval. A registrational trial design for VMT-α-NET has not yet been submitted to the FDA; the company states only it expects “meaningful regulatory engagement in 2026.” Clinical failures or FDA disagreement on trial design could materially delay or end any programme.
• Sustained and accelerating dilution: Common shares outstanding rose from ~64M (FY2024 weighted avg) to 114M by 31 March 2026, a ~78% increase in one year. The February 2026 offering issued 39.6M shares at $3.79. Additional equity raises are likely before any potential commercialisation.
• Accelerating cash burn: R&D expenses doubled from $41.6M in FY2024 to $84.2M in FY2025. Q1 2026 net loss of $26.2M implies an annualised burn rate of approximately $105M+. Manufacturing build-out is adding capex on top of operating losses.
• Manufacturing execution risk: The company is simultaneously running three clinical trials and constructing a multi-site regional manufacturing network. Construction delays, supply disruptions, or regulatory hurdles at manufacturing sites could impair clinical timelines and require additional capital.
• Large-pharma competitive threat: Novartis (>$2B in RPT revenues), BMS (RayzeBio acquisition $4.1B), AstraZeneca (Fusion Pharma), and Eli Lilly (Point Biopharma) have far greater resources and are actively expanding radiopharmaceutical pipelines. Competitive displacement remains a material risk.

3. What Does This Company Actually Do?

Perspective Therapeutics is developing a new class of cancer drugs called targeted alpha therapies (TATs). The concept: pair a radioactive isotope that emits alpha particles with a targeting molecule that seeks out a specific protein expressed on cancer cells, and you get a radiopharmaceutical that travels through the bloodstream, homes in on tumour cells, and irradiates them from the inside while largely sparing healthy tissue.

The company’s differentiating choice of isotope is lead-212 (²¹²Pb). Alpha particles have roughly 100 times the linear energy transfer of the beta particles used by established radiopharmaceuticals such as Lutathera and Pluvicto. They also travel only two to ten cell diameters in tissue, making them far more locally precise. ²¹²Pb is short-lived (half-life approximately 10.6 hours) and decays through a chain that delivers an alpha particle at the tumour site. The company has developed a proprietary ²²⁴Ra/²¹²Pb generator platform to produce ²¹²Pb on-site or near-site, building a regional supply infrastructure.

Each targeting peptide can be labelled with either a diagnostic isotope (²⁰³Pb or ⁶⁸Ga) for imaging and patient selection, or with ²¹²Pb for therapy. This “theranostic” approach allows clinicians to confirm a patient’s tumour expresses the target receptor before administering the therapeutic dose — personalising treatment and improving the probability of response.

The company is pre-commercial. Its only current revenue is grant income from NIH-funded research ($884K in FY2025). All three clinical programmes are in Phase 1/2a dose-finding studies in the United States.

Segment	% of revenue	What it is
NIH Grant Revenue	100% ($0.9M FY2025)	Research grant income from the National Institutes of Health, supporting translational research activities on the 212Pb platform. This is the sole revenue line. The company is pre-commercial; all clinical programmes are pre-approval and pre-revenue. Geographic breakdown not applicable.

Note: company is pre-commercial; no operating product segments exist. Upon potential approval and launch of VMT-α-NET, the primary commercial segment would be neuroendocrine tumour treatment. Additional potential segments would follow from VMT01 (melanoma) and PSV359 (solid tumours) approvals.

4. The Business Model

How a clinical-stage radiopharmaceutical company funds itself. Perspective Therapeutics does not yet generate product revenue. It funds operations through equity capital raises and NIH grant income. The February 2026 underwritten offering raised approximately $164M net proceeds through the issuance of 39.6M shares at $3.79 per share, along with pre-funded warrants for a further 6.6M shares. Prior to this, the February 2023 merger between Viewpoint Molecular Targeting, Inc. and Isoray, Inc. was the founding equity event for the current entity. Future funding before commercialisation is expected to require additional equity or partnership arrangements.

Unit economics (projected, not yet achieved). The commercial model, if VMT-α-NET receives regulatory approval, would be a hospital-facing radiopharmaceutical treatment course. Comparables include Novartis’s Lutathera (list price approximately $130,000 per course for NETs) and Pluvicto (approximately $42,500 per dose, typically 6 doses for prostate cancer). Gross margins for approved branded radiopharmaceuticals are typically high (60–80%+) once manufacturing overhead is absorbed at scale. The company’s regional manufacturing approach is designed to reduce the logistics cost and spoilage risk associated with the short half-life of ²¹²Pb.

Moat. The proprietary ²²⁴Ra/²¹²Pb generator technology creates an internal isotope supply chain that is capital-intensive and time-consuming to replicate. The clinical data package being assembled for VMT-α-NET — across three dose cohorts, with theranostic patient selection, in a rare indication with high unmet need — represents a regulatory filing asset that competitors could only reproduce by running equivalent multi-year trials. Intellectual property around the ²¹²Pb platform chemistry and targeting peptide conjugation provides additional protection, per the company’s 10-K disclosures.

Subsidies and regulatory credits. Perspective receives NIH grant funding for specific research activities ($884K in FY2025, $1.45M in FY2024). This is not a material portion of operational funding. No government production subsidies or tax credits for the manufacturing network were identified in the company’s filings reviewed during this session. The company has benefited from the Deferred Income balance of $26.6M on its noncurrent balance sheet — this is a non-cash government-related deferred revenue item recorded as part of the Viewpoint/Isoray merger and relates to prior DoE/NIH-related contractual arrangements; it is not recurring operational revenue.

Isotope supply chain. ²¹²Pb is produced from the decay of radium-224, which is derived from thorium-228. The upstream isotope supply chain is constrained globally; most radium-224 is sourced from a small number of facilities. Perspective’s proprietary generator system is designed to bring production closer to the point of patient administration, addressing the key logistics challenge of the isotope’s ~10.6-hour half-life. The Chicago flagship manufacturing site is expected to complete construction in 2026; a Los Angeles site is also in development.

5. Financial Health

Note: Perspective Therapeutics is a pre-commercial clinical-stage company. Standard financial metrics — gross margin, operating margin, P/E, EV/EBITDA — are not applicable in the conventional sense. The key financial indicators are cash position, burn rate, and capital runway. All FY2025 figures sourced directly from the company’s FY2025 press release (GlobeNewswire, 16 March 2026, primary source). Q1 2026 figures from Q1 2026 press release (GlobeNewswire, 11 May 2026, primary source). FY2024 figures cross-referenced from the FY2025 comparative income statement. Revenues shown are NIH grant revenues only; not product revenues.

FCF = operating cash flow minus capital expenditure. As a pre-commercial company, FCF is deeply negative. In FY2025, total cash and short-term investments declined from approximately $227M to $145M, a reduction of approximately $82M. This reflects the combined effect of operating losses offset by non-cash items and working capital movements, plus approximately $19M in net property and equipment additions (manufacturing capex). In Q1 2026, PP&E increased by a further $15.9M to $92.5M, reflecting accelerated manufacturing build-out. The company does not separately report an operating cash flow statement summary in its quarterly press releases; full cash flow statements are available in the 10-K (filed March 2026) and 10-Q (filed May 2026) on SEC EDGAR.

Fiscal year	Revenue (grant, $M)	YoY %	GAAP EPS (diluted)	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$0	N/M	—	—	$0	—
FY2022	~$0	N/M	~$(0.80) ¹	—	$0	—
FY2023	~$1.4M ²	N/M	$(1.74) ²	—	$0	~$1.7M note ²
FY2024	$1.5M	+7%	$(1.23)	—	$0	$1.6M note ³
FY2025	$0.9M	−40%	$(1.40)	—	$0	$1.6M note ³

¹ FY2022 EPS shown is post-1:10 reverse stock split basis (split effected June 2024). FY2022 was the final year of the legacy Isoray, Inc. entity prior to the February 2023 merger with Viewpoint Molecular Targeting. EPS figure from search aggregators; primary source not retrieved during this session. Net loss FY2022 approximately $10.8M.

² FY2023 net loss approximately $46.5M; EPS $(1.74) post-split adjusted. First full year as Perspective Therapeutics (post February 2023 merger). Data from search aggregators; primary press release not directly retrieved during this session. LT debt is noncurrent note payable, not traditional bond debt; exact FY2023 balance estimated.

³ LT debt column denotes “note payable, net of current portion” per audited balance sheets: $1.625M (FY2024) and $1.569M (FY2025), per FY2025 annual press release (primary source). No traditional bond or bond-equivalent debt exists. Adjusted EPS not reported; company does not publish non-GAAP EPS as a clinical-stage entity. GAAP EPS includes all items, including the $10M non-cash preclinical asset impairment in Q4 2025 and $24M goodwill impairment in FY2024.

Quarterly breakdown (most recent first):

Quarter	Revenue (grant)	Operating EPS	GAAP EPS
Q1 2026	$0.08M	$(0.25)	$(0.25)
Q4 2025	est. ~$0.18M ⁴	$(0.51) ⁴	$(0.51) ⁴
Q3 2025	est. ~$0.18M ⁴	$(0.35)	$(0.35)
Q2 2025	est. ~$0.18M ⁴	$(0.29) ⁴	$(0.29) ⁴
Q1 2025	$0.34M	$(0.25)	$(0.25)
FY2025 Total	$0.88M	—	$(1.40)

⁴ Q4 2025 EPS derived as FY2025 $(1.40) minus nine-month $(0.89) = $(0.51). Q2 2025 EPS derived as nine-month $(0.89) minus Q1 $(0.25) minus Q3 $(0.35) = $(0.29). Q3 and Q1 2025 EPS from primary sources (Q3 2025 press release; Q1 2026 press release comparative). Q2–Q4 grant revenue estimated as FY2025 total $884K minus Q1 $342K divided three ways; exact quarterly split not individually disclosed. Q4 2025 EPS includes $10M non-cash impairment loss on deprioritised preclinical asset.

Cash and liquidity: As of 31 March 2026: cash $54.0M + short-term investments $217.0M = $271M total. Net tangible assets as of 31 March 2026: total assets $410.8M, total liabilities $63.3M, total stockholders’ equity $347.4M. No bank debt, no revolving credit facility disclosed.

6. Valuation & Market Data

Raw metrics, May 2026. Not opinions on whether the stock is cheap or expensive.

Metric	Value
Market cap	~$434M (at ~$3.81/share × 114M shares; May 2026)
Enterprise value	~$165M (market cap ~$434M + note payable ~$1.6M − cash & investments $271M; May 2026)
Trailing P/E (GAAP)	N/A (net loss; GAAP EPS $(1.40) FY2025)
P/E (forward)	N/A (no earnings forecast meaningful for pre-commercial clinical company)
P/S (TTM)	N/M (grant revenue $0.88M FY2025; not a product revenue metric)
EV/EBITDA (TTM)	N/A (negative EBITDA; pre-commercial)
P/FCF	N/A (negative FCF)
52-week high	$6.16
52-week low	$1.96
Current price	~$3.81 (13 May 2026; approximately 38% below 52-week high, 94% above 52-week low)
Short interest (% of float)	~10.0–11.1% of float (~10.1M shares short; May 2026)
Days to cover	Data not available — verify at finra.org short interest data
Dividend	None; no dividend paid or declared

Note: Standard valuation multiples (P/E, P/S, EV/EBITDA, P/FCF) are not meaningful for a pre-commercial clinical-stage company with sub-$1M in non-product revenues. The negative enterprise value (~$165M) reflects that cash and investments significantly exceed market capitalisation net of debt — a common feature of well-funded pre-commercial biotechs. The relevant investor framework is cash runway versus clinical milestones, not earnings multiples.

7. What Are They Building / What’s Coming?

Perspective has four programmes at varying stages of development, all centred on the same ²¹²Pb alpha therapy platform.

VMT-α-NET (lead programme — neuroendocrine tumours). Phase 1/2a multi-centre open-label dose-finding study (NCT05636618) of [²¹²Pb]VMT-α-NET in unresectable or metastatic SSTR2-positive neuroendocrine tumour patients who have not received prior radiopharmaceutical therapy. Three dose cohorts have been completed: Cohort 1 (2.5 mCi, 2 patients), Cohort 2 (5.0 mCi, 46 patients, now closed), and Cohort 3 (6.0 mCi, 20 patients, now closed). Cohort 4 is open for recruitment. Updated data presented at AACR in April 2026 (data cut-off 4 March 2026) showed 43% objective response rate in Cohort 2 evaluable patients, across 64 patients in the safety population with no dose-limiting toxicities or Grade 5 events. As of 30 April 2026, the first 23 Cohort 2 patients have had at least 60 weeks of follow-up; all 46 Cohort 2 patients are expected to have 60 weeks of follow-up by late 2026. The company states it believes its “data package positions us for meaningful regulatory engagement in 2026 to align on the path forward” for a registrational trial. A proof-of-concept cohort in meningioma patients has also been opened, citing potential for an expedited development path given the absence of approved systemic therapies for this disease (per Q1 2026 press release, 11 May 2026).

VMT01 (Phase 1/2a — melanoma). VMT01 targets the melanocortin-1 receptor (MC1R) expressed on melanoma cells. The Phase 1/2a study (NCT05655312) evaluates VMT01 as monotherapy at 3.0 mCi and in combination with nivolumab (BMS’s Opdivo, a PD-1 checkpoint inhibitor) at 3.0 mCi, in heavily pre-treated patients with histologically confirmed melanoma and MC1R-positive imaging scans. As of February 28, 2026, 10 patients had received VMT01 3.0 mCi treatment (6 combo, 4 mono). Both cohorts are now closed for enrolment. By late 2026, these 10 patients will have had at least 24 weeks of follow-up sufficient for at least one post-treatment scan. A clinical data update is expected to be submitted for presentation at a medical conference in 2026 (per management, FY2025 press release, 16 March 2026).

PSV359 (Phase 1/2a — FAP-positive solid tumours). PSV359 targets fibroblast activation protein-alpha (FAP-α), expressed across multiple high-prevalence solid tumours including colorectal, pancreatic, lung, and breast cancers. As of 30 April 2026, nine patients have been dosed (2 in Cohort 1 at 2.5 mCi; 7 in Cohort 2 at 5.0 mCi), with Cohort 3 now open for recruitment. By late 2026, the dosed patients will have had at least 32 weeks of follow-up — sufficient for at least one post-full-treatment scan. Initial Phase 1 data expected at medical conferences in late 2026 (per Q1 2026 press release, 11 May 2026).

PSV594 (preclinical / first-in-human imaging stage — CCK2R-targeted). In May 2026, Perspective presented first-in-human imaging data for PSV594, designed to target the cholecystokinin-2 receptor (CCK2R), expressed across several hard-to-treat cancers. Both preclinical and first-in-human images demonstrate clean, precise tumour uptake with limited kidney retention, suggesting a potentially favourable therapeutic index. The company states that if this construct meets development criteria, pre-IND filing activities will follow (per Q1 2026 press release, 11 May 2026).

Manufacturing infrastructure. The company is building a regional supply network for finished drug product candidates, enabled by its proprietary ²²⁴Ra/²¹²Pb generator platform. The Chicago-area flagship site is on track to complete construction in 2026. A Los Angeles-area complementary site is under development. Management stated in the Q1 2026 press release that it has “plans beyond our current footprint.” This infrastructure is designed to support both clinical supply for ongoing trials and, if products receive approval, commercial operations. Capital expenditure on property and equipment was approximately $19M net in FY2025 and approximately $15.9M net in Q1 2026 alone, reflecting the pace of the build-out.

8. Competitive Landscape

The global radiotheranostics market was valued at approximately $4.75B in 2025 and is projected to reach approximately $44B by 2034, at a ~28% CAGR (Fortune Business Insights, 2026). The targeted alpha therapy segment was approximately $1.0B in 2025, growing at ~17% annually. Perspective competes both directly in specific tumour indications and broadly for capital, talent, isotope supply, and clinical infrastructure against larger and better-resourced players.

SSTR2/NETs competitive dynamics: Novartis’s Lutathera ([¹⁷⁷Lu]Lu-DOTATATE) is the current standard of care for SSTR2+ NETs, generating over $1B in annual revenue. Lutathera is a beta emitter. Perspective positions VMT-α-NET as an alpha-based next-generation option for patients with heterogeneous SSTR2 expression or progression on beta therapy. Sanofi’s Alphamedix, a competing SSTR2-targeted alpha therapy, was discontinued in 2025, leaving Perspective as the only lead-212-based programme in this indication.

Alpha therapy landscape: Bayer’s Xofigo (radium-223 dichloride) is the only currently approved targeted alpha therapy globally, for bone-metastatic castration-resistant prostate cancer. It uses a different mechanism, different target, and no theranostic imaging component, but established the regulatory precedent for approved alpha therapy. BMS (via its $4.1B acquisition of RayzeBio in January 2024) is developing actinium-225-based targeted alpha therapies — a different alpha isotope from Perspective’s ²¹²Pb. AstraZeneca (via Fusion Pharma) and Eli Lilly (via Point Biopharma, acquired for ~$1.4B in 2023) have also committed substantial capital to the radiopharmaceutical space.

Peer	Market Cap (May 2026)	FY2025 Revenue	P/E (TTM, May 2026)	Primary RPT product / differentiator
Novartis (NVS)	~$230B	~$45B total; Lutathera+Pluvicto >$2B combined (per Novartis 2025 annual report)	~18x	Lutathera (Lu-177, SSTR2, NETs — approved) and Pluvicto (Lu-177, PSMA, prostate cancer — approved). Large pharma scale. Principal commercial competitor in the NETs indication Perspective is targeting.
Bayer (BAYRY)	~$16B	~€46B total; Xofigo ~€600M (per Bayer 2025 annual report)	~14x	Xofigo (Ra-223 alpha emitter, bone-met CRPC — approved). Only currently approved targeted alpha therapy globally; different target and indication from Perspective, but the established regulatory and clinical precedent for the modality.
Lantheus Holdings (LNTH)	~$4.9B	$1.54B (per Lantheus FY2025 press release)	~20x	PYLARIFY (PSMA PET diagnostic imaging, prostate cancer). Primarily a diagnostics business with therapeutic pipeline ambitions. Competes for capital, clinical infrastructure, and institutional attention in the radiopharmaceutical space.
Perspective Therapeutics (CATX)	~$434M	$0.9M grant revenue (pre-commercial; per FY2025 press release)	N/A	[212Pb]-based targeted alpha platform; VMT-α-NET (NETs, Phase 1/2a), VMT01 (melanoma), PSV359 (solid tumours). Only 212Pb clinical programme in SSTR2+ NETs after Sanofi’s Alphamedix discontinuation.

Market cap figures from web searches during this session (May 2026). Revenue figures from publicly reported annual results; Novartis and Bayer revenues include all business segments. Government subsidies to Bayer and Novartis are not identified as material to their radiopharmaceutical divisions based on available public disclosure. Exact RPT sub-segment revenues are disclosed within larger company filings.

9. Leadership and Ownership

CEO: Thijs (Johan) Spoor. Appointed President and CEO in February 2023 at the time of the Viewpoint Molecular Targeting/Isoray merger. Spoor came from the Viewpoint side of the transaction and was central to the strategic vision behind the ²¹²Pb radiopharmaceutical platform. He previously held commercial and executive roles at Jubilant Radiopharma and Sofie Biosciences and remains a Board Director. He presented at the J.P. Morgan Healthcare Conference in January 2026, reaffirming the company’s clinical strategy (per Seeking Alpha transcript).

CMO: Marcus Puhlmann. Chief Medical Officer, responsible for clinical development across all three programmes. Joined post-merger. Received 150,000 stock options as annual equity award in March 2026 (per Form 4).

CFO: Joel Sendik. Chief Financial Officer; present at investor conferences alongside the CEO and CMO. Responsible for capital structure, fundraising, and financial reporting.

Board of Directors (2026 Annual Meeting slate, per DEF 14A proxy filed 2026): Thijs Spoor (CEO/Director), Lori A. Woods (Independent), Heidi Henson (Independent), Robert F. Williamson III (Independent), Frank Morich (Independent), Maya Martinez-Davis (Independent). The 2026 Annual Meeting is scheduled for 27 May 2026.

Major institutional shareholders (per 13F/13G filings and search data, May 2026): BlackRock ~6.1%; Qatar Investment Authority (Qatar Holding LLC) ~6.2% (7.07M shares; per Schedule 13G filed February 2026); TCG Crossover Management ~6.9% (per 13G); The Vanguard Group ~4.7%; Morgan Stanley ~2.6% (reduced from >5%, per Schedule 13G/A filed May 2026). Lantheus Holdings is also cited as a strategic holder, reflecting the theranostics ecosystem investment thesis.

Insider transactions (SEC Form 4 filings, September 2025 — March 2026):

Name	Date	Type	Shares	Price	Value	Plan Type
Marcus Puhlmann (CMO)	02 Mar 2026	Grant (options)	150,000	$0 exercise	2026 annual equity award	Compensation grant
Robert F. Williamson III (Director)	02 Mar 2026	Grant (options)	50,000	$0 exercise	2026 annual director award; vests 02 Mar 2027	Compensation grant
Lori A. Woods (Director)	02 Mar 2026	Grant (options)	50,000	$0 exercise	2026 annual director award	Compensation grant
Maya Martinez-Davis (Director)	02 Mar 2026	Grant (options)	50,000	$0 exercise	2026 annual director award; vests 02 Mar 2027	Compensation grant
Frank Morich (Director)	02 Mar 2026	Grant (options)	50,000	$0 exercise	2026 annual director award	Compensation grant
Maya Martinez-Davis (Director)	03 Sep 2025	Grant (options)	75,000	$3.38	Vests monthly over 36 months	Compensation grant

All transactions are compensation-related equity grants (stock options), not discretionary open-market purchases or 10b5-1 plan sales. No discretionary insider buying or selling identified in Form 4 searches during this session. For complete transaction history, verify at SEC EDGAR (sec.gov, search CATX Form 4).

10. Risks and Challenges

• Clinical trial failure (Operational): All three programmes are in Phase 1/2a. Oncology drug development failure rates for Phase 2 exceed 50% historically. An unexpected safety signal, lack of efficacy, or results insufficient for a registrational trial would materially impair the company’s value and require full strategic re-evaluation.
• Regulatory path uncertainty (Regulatory): The company has not yet agreed a registrational trial design with the FDA for VMT-α-NET. The company states it believes its data package supports “meaningful regulatory engagement in 2026.” The FDA may request additional cohorts, longer follow-up, a different control arm, or alternative patient selection criteria, potentially adding years to the development timeline and consuming additional capital.
• Ongoing shareholder dilution (Financial): Common shares outstanding increased ~78% in approximately one year (64M weighted average FY2024 to 114M by 31 March 2026). With no commercial revenue and a cash runway through late 2027, additional equity raises are probable before any potential product approval. The company has no committed credit facility disclosed in its filings.
• Cash burn acceleration (Financial): R&D expenses doubled from $41.6M in FY2024 to $84.2M in FY2025. Q1 2026 net loss of $26.2M implies an annualised run rate of approximately $105M. Manufacturing capex of approximately $15.9M in Q1 2026 alone adds to cash consumption beyond operating losses. If timelines slip or clinical activity increases further, the late-2027 cash runway estimate could compress.
• Manufacturing execution and cost risk (Operational): Building a multi-site regional radiopharmaceutical manufacturing network in parallel with running three clinical trials is operationally complex. Construction delays, regulatory clearances for manufacturing sites, supply constraints in the ²²⁴Ra feedstock, or cost overruns could impair clinical timelines and require additional capital.
• Isotope supply chain concentration (Concentration): ²¹²Pb is derived from radium-224, produced at a small number of nuclear facilities globally. Disruption to upstream isotope supply through regulatory action, geopolitical events, or facility incidents could halt clinical trials and constrain commercial supply indefinitely.
• Large-pharma competitive displacement (Competitive): BMS (RayzeBio acquisition, Ac-225 platform), AstraZeneca (Fusion Pharma), Novartis (RPT expansion), and Eli Lilly (Point Biopharma) have collectively committed billions of dollars to radiopharmaceutical development. Competitive displacement from a better-resourced programme achieving earlier Phase 3 readout in SSTR2+ NETs would erode VMT-α-NET’s first-mover positioning.
• Key person risk (Operational): The company employs approximately 166 people and its programmes depend on a concentrated senior leadership team. Loss of CEO Thijs Spoor, CMO Marcus Puhlmann, or critical scientific personnel would likely disrupt programme execution and could affect the stock price materially, given the small size of the team relative to operational scope.
• Payer and reimbursement uncertainty (Commercial): Even upon potential regulatory approval, payers (CMS, NICE, other national bodies) must agree to reimburse at a price that supports the commercial model. Radiopharmaceutical reimbursement decisions involve complex logistics, hospital infrastructure requirements, and treatment pathway positioning. A low reimbursed price or restricted access pathway would substantially reduce peak revenue potential.
• Short interest elevation (Market): Short interest of approximately 10–11% of float is elevated for a small-cap biotech, suggesting a segment of the market is positioned for a price decline. This creates binary risk around clinical data readouts: a positive result may trigger a short squeeze; a disappointing result could be amplified by additional short selling.

11. Recent Developments

• 11 May 2026 — Q1 2026 results and business update published. Net loss $26.2M ($0.25/share); R&D expenses $21.4M (+50% year-over-year); G&A $7.0M; cash and investments $271M. All three clinical programmes confirmed on track. Cohort 4 of VMT-α-NET now open for recruitment. First-in-human PSV594 imaging data publicly presented. All Cohort 2 patients expected to have 60-week follow-up by late 2026 (per GlobeNewswire, 11 May 2026).
• May 2026 — PSV594 first-in-human imaging data presented. Perspective presented FIH imaging data for PSV594, its CCK2R-targeted candidate. Images show clean, precise tumour uptake with limited kidney retention, suggesting a favourable therapeutic index for potential clinical development. This is the first public human imaging data for this asset (per Q1 2026 press release, 11 May 2026).
• 20 Apr 2026 — Updated VMT-α-NET data at AACR Annual Meeting 2026. Data cut-off 4 March 2026; additional ~12 weeks of follow-up versus ASCO-GI January 2026 data. Safety analysis in 64 patients across all three cohorts: no DLTs, no Grade 5 events, Grade ≥3 events in 37.5% of patients. Updated 43% ORR in Cohort 2 evaluable patients. First 23 Cohort 2 patients had at least 48 weeks of follow-up as of 30 April 2026 (per GlobeNewswire, 20 April 2026).
• Feb 2026 — $164M underwritten equity offering completed. 39.6M shares issued at $3.79/share plus pre-funded warrants for 6.6M additional shares. Net proceeds approximately $164M. Shares outstanding increased from ~74.3M (YE 2025) to ~114M by 31 March 2026. Cash position increased from $145M (YE 2025) to $271M (31 March 2026), extending management’s cash runway guidance to late 2027 (per FY2025 press release, 16 March 2026).
• 16 Mar 2026 — Full year 2025 results reported. Net loss $103.1M ($1.40/share); R&D $84.2M (doubles year-over-year, including $10M non-cash impairment on deprioritised preclinical asset); G&A $30.2M; cash and investments $145M at year end. Shares outstanding 74.3M at 31 December 2025 (per GlobeNewswire, 16 March 2026, primary source).
• 09 Jan 2026 — VMT-α-NET data at ASCO Gastrointestinal Cancers Symposium. Updated data with data cut-off 10 December 2025. In 56-patient safety population: no DLTs, no Grade 5 events. In 25 evaluable patients (Cohorts 1 and 2): 19/25 (76%) without progression and alive; 9/23 Cohort 2 patients (39%) achieved objective response per RECIST v1.1; seven patients showed deepening of best response versus prior ESMO 2025 update (per GlobeNewswire, 9 January 2026).

12. Key Dates Coming Up

• 27 May 2026 — Annual Meeting of Stockholders, Sheraton Grand Chicago Riverwalk, Chicago. Agenda includes director elections (slate: Spoor, Woods, Henson, Williamson, Morich, Martinez-Davis), executive compensation vote, and auditor ratification (per DEF 14A proxy, 2026).
• Expected August 2026 — Q2 2026 earnings release and business update (exact date not yet confirmed; verify at perspectivetherapeutics.com/investors).
• Expected late 2026 — VMT-α-NET Cohort 2 full 60-week follow-up dataset. All 46 Cohort 2 patients expected to have 60 weeks of follow-up by late 2026. This is the key dataset the company expects will support FDA engagement on a registrational trial pathway.
• Expected late 2026 — VMT-α-NET Cohort 3 DLT patients 48-week follow-up. The eight DLT-assessment patients in Cohort 3 (6.0 mCi) are expected to have 48 weeks of follow-up by late 2026. This data will contribute to the full clinical evidence package.
• Expected late 2026 — VMT01 melanoma data readout (24-week follow-up). The 10 patients dosed at 3.0 mCi since September 2025 (mono and combo with nivolumab) will have had at least 24 weeks of follow-up by late 2026. Clinical update expected at a medical conference.
• Expected late 2026 — PSV359 initial Phase 1 data. Nine dosed patients (Cohorts 1 and 2) expected to have at least 32 weeks of follow-up by late 2026. Initial data readout targeted at a medical conference in H2 2026.
• Expected during 2026 — Chicago flagship manufacturing site completion. The company’s primary regional manufacturing site in the Chicago area expected to complete construction during 2026 (per Q1 2026 press release, 11 May 2026).

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Last Updated: 16 May 2026

Eli Lilly and Company (NYSE: LLY) is one of the world's largest pharmaceutical companies, headquartered in Indianapolis, Indiana, and founded in 1876. The company has transformed into the world's most valuable pharmaceutical business, driven by the extraordinary commercial success of tirzepatide — marketed as Mounjaro for type 2 diabetes and Zepbound for chronic weight management. With FY2025 revenue of $65.2bn and a market capitalisation exceeding $950bn, Lilly sits at the epicentre of the GLP-1 revolution reshaping global healthcare. For general market data, visit ChartsView Live Charts.

1. Company Snapshot

Field	Value
Full name	Eli Lilly and Company
Ticker	NYSE: LLY
Sector	Healthcare
Industry	Pharmaceuticals
Founded	1876, Indianapolis, Indiana, USA
Headquarters	Indianapolis, Indiana, USA
CEO	David A. Ricks (Chairman & CEO since January 2017)
Market cap	~$951bn (May 2026, per web search)
Revenue (FY2025)	$65.2bn
Net income (FY2025, GAAP)	~$20.6bn
Employees	~45,000 (approximate, per FY2025 annual report)
Primary exchange	NYSE (also Frankfurt: LLIA)
Fiscal year end	31 December
Website	lilly.com / investor.lilly.com

2. Bull Case vs Bear Case

Distilled from the full report below — factual only, no ratings.

Bull Case

• Tirzepatide dominance: Mounjaro and Zepbound (both tirzepatide) generated an estimated combined $31bn+ in FY2025 revenue, making tirzepatide one of the fastest-selling drugs in pharmaceutical history. Clinical superiority over semaglutide in head-to-head trials supports continued market-share gains.
• Pipeline depth: Retatrutide (triple agonist GIP/GLP-1/glucagon) is in Phase 3 for obesity, oral GLP-1 (Foundayo/orforglipron) launched April 2026 for diabetes, and oral tirzepatide is in development — extending the franchise beyond injectable therapy.
• Revenue acceleration: FY2025 revenue of $65.2bn represented 44.8% YoY growth; management raised FY2026 guidance to $82–85bn (per Q1 2026 earnings call), implying continued 26–30% growth as manufacturing capacity scales.
• Alzheimer's franchise emerging: Kisunla (donanemab) received FDA approval in July 2024 for early symptomatic Alzheimer's disease, opening a new therapeutic area with multi-billion-dollar long-term potential.
• Manufacturing investment: Lilly has committed over $23bn in US manufacturing expansion since 2023, with a further $4.5bn Indiana investment announced May 2026, building durable supply infrastructure to meet GLP-1 demand.

Bear Case

• IRA drug pricing risk: Under the Inflation Reduction Act, Mounjaro/tirzepatide is a candidate for Medicare price negotiation, which could materially compress margins on a product that represents the majority of revenue.
• GLP-1 competition intensifying: Novo Nordisk's Ozempic/Wegovy franchise commands significant market share; multiple oral GLP-1 candidates from Roche, Viking Therapeutics, and others are advancing in trials, threatening long-term tirzepatide pricing power.
• High valuation concentration risk: At P/FCF ~106x and EV/EBITDA ~35x, the stock embeds significant growth expectations. A clinical setback, slower uptake, or pricing pressure on tirzepatide would disproportionately affect the valuation.
• Manufacturing execution risk: The $23bn+ US manufacturing expansion is the largest in Lilly's history. Construction delays, regulatory approval lags at new sites, or quality control failures could constrain supply and revenue.
• GAAP vs. non-GAAP gap: Significant acquired in-process R&D (IPR&D) charges and amortisation of intangibles from acquisitions reduce reported GAAP earnings relative to non-GAAP; investors tracking GAAP metrics face higher apparent valuations than non-GAAP-focused analysis suggests.

3. What Does This Company Actually Do?

Eli Lilly discovers, develops, manufactures, and sells prescription medicines primarily in the areas of diabetes, obesity, oncology, immunology, and neuroscience. Founded by Colonel Eli Lilly in 1876, it is now the world's largest pharmaceutical company by market capitalisation. The company sells branded, patent-protected drugs to pharmacies, hospitals, pharmacy benefit managers (PBMs), and government healthcare programmes in over 110 countries. It earns revenue when patients (via insurers, PBMs, or out-of-pocket) pay for its drugs, and retains pricing power while patents are in force.

The commercial centrepiece is tirzepatide (GIP/GLP-1 dual agonist), sold as Mounjaro for type 2 diabetes and Zepbound for chronic weight management. Tirzepatide has demonstrated superior efficacy to existing GLP-1 agonists in clinical trials and became one of the fastest-adopted new drugs in US history after its 2022 launch. By FY2025, tirzepatide products alone represented the majority of Lilly's revenue. The company also has a significant oncology portfolio led by Verzenio (abemaciclib for breast cancer) and an emerging Alzheimer's franchise via Kisunla (donanemab).

Geographic revenue is predominantly US-driven (~70%) given tirzepatide's US coverage and the US market's premium pricing structure, though international expansion is accelerating as regulatory approvals widen.

Segment	% of revenue	What it is
Diabetes & Obesity (Incretin medicines)	~71% (~$46.3bn)	Mounjaro (tirzepatide, type 2 diabetes), Zepbound (tirzepatide, chronic weight management), Trulicity (dulaglutide, legacy GLP-1 now declining as tirzepatide cannibalises), Humalog and Humulin (insulin, established products in decline). This segment has driven virtually all of Lilly's revenue acceleration since 2022.
Oncology	~12% (~$7.8bn)	Verzenio (abemaciclib for HR+/HER2- breast cancer, adjuvant and metastatic) generates the majority; Cyramza (ramucirumab for multiple GI and lung cancers) and Jaypirca (pirtobrutinib for B-cell malignancies) contribute smaller but growing amounts. Verzenio has grown to become a global blockbuster with ~$5.5bn in annual revenue.
Immunology	~7% (~$4.6bn)	Taltz (ixekizumab for plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis), Olumiant (baricitinib for rheumatoid arthritis and alopecia areata), and Ebglyss/Kynmobi (lebrikizumab for atopic dermatitis, expanding internationally). Competition from newer biologics and biosimilars creates pricing pressure.
Neuroscience	~3% (~$2.0bn)	Emgality (galcanezumab, preventive migraine), Kisunla (donanemab, early symptomatic Alzheimer's disease, FDA-approved July 2024 and ramping commercially), and Jardiance co-promotion revenue (empagliflozin via alliance with Boehringer Ingelheim).
Other pharmaceutical	~7% (~$4.5bn)	Established and legacy products including Forteo (teriparatide for osteoporosis), Alimta (pemetrexed, now largely off-patent), Cialis generic revenue, and various ex-US products. Revenue in this segment is in structural decline.

4. The Business Model

How Lilly makes money. Eli Lilly generates revenue by selling branded, patent-protected prescription medicines at premium prices. The core model is: invest heavily in R&D to discover or acquire differentiated drugs, obtain regulatory approval and patent protection, then commercialise globally over the patent life (typically 10–20 years from filing). Revenues are primarily collected from pharmacy benefit managers, wholesalers, hospitals, and government programmes, with net realised prices reflecting list prices minus rebates. The tirzepatide franchise (Mounjaro + Zepbound) exemplifies this model: a novel molecule with demonstrated superiority, priced at ~$1,000/month in the US (before rebates), yielding extraordinary margins.

Unit economics. Lilly's gross margin is typically 80%+ on branded drugs, reflecting very low marginal manufacturing costs relative to R&D-amortised pricing. Operating margin for FY2025 was significantly impacted by $7.84bn in capital expenditure (manufacturing scale-up) and elevated R&D spending (~$10bn+). Net income of ~$20.6bn on $65.2bn revenue implies a net margin of approximately 32%. The non-GAAP adjusted EPS of $24.21 vs GAAP EPS of $22.95 reflects primarily amortisation of intangibles and acquired IPR&D charges. FCF was $8.97bn (operating cash flow $16.81bn minus capex $7.84bn per FY2025 cash flow statement).

Moat. Lilly's competitive position rests on: (1) patent exclusivity on tirzepatide, with core US composition-of-matter patents expected to run through approximately 2036; (2) clinical data superiority — tirzepatide has demonstrated superior weight loss outcomes versus semaglutide in the SURMOUNT-5 head-to-head trial; (3) manufacturing scale — producing biologics-grade injectables at the volumes required for tens of millions of patients is a substantial operational barrier; and (4) physician relationships and brand recognition in diabetes and endocrinology, built over 50+ years with Humalog and Trulicity. These factors create significant time and capital barriers for any competitor attempting to displace tirzepatide as the market-leading incretin.

Subsidies and regulatory credits. Eli Lilly does not rely on direct government subsidies in the traditional sense. However, the company benefits significantly from the US patent system and data exclusivity provisions under the Biologics Price Competition and Innovation Act (BPCIA), which prevent biosimilar competition for 12 years post-approval. Conversely, the Inflation Reduction Act (IRA) is a material risk: under IRA provisions, the US government can negotiate prices for Medicare Part D drugs, and tirzepatide is a candidate. The IRA-negotiated price takes effect in 2027 for Medicare patients, which could reduce net revenue per unit for the portion of demand covered by Medicare Part D.

R&D investment. Lilly invested approximately $10bn+ in research and development in FY2025, sustaining a pipeline of 50+ clinical-stage molecules. This represents approximately 15% of revenue. Unlike many large pharma companies, Lilly has chosen to concentrate its pipeline in incretin biology, oncology, immunology, and neuroscience rather than pursue broad diversification. This focused approach has produced the tirzepatide franchise but creates concentration risk if the incretin category faces clinical or commercial headwinds.

5. Financial Health

All figures sourced from Eli Lilly's FY2025 earnings press release and EDGAR XBRL data (CIK 0000059478). FCF = operating cash flow minus capital expenditures, per the FY2025 cash flow statement.

Fiscal year	Revenue	YoY %	GAAP EPS (diluted)	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$28.32bn	+15.4%	$6.92	$8.15	$3.74	$15.35bn
FY2022	$28.54bn	+0.8%	$6.40	$7.53	$3.92	$14.74bn
FY2023	$34.12bn	+19.6%	$6.32	$8.65	$4.52	$18.32bn
FY2024	$45.04bn	+32.0%	$10.59	$13.37	$5.20	$28.53bn
FY2025	$65.2bn	+44.8%	$22.95	$24.21	$5.72	$40.87bn

Note: FY2021–FY2024 GAAP EPS and Adjusted EPS are sourced from Lilly's annual results press releases and EDGAR filings. LT debt figures are noncurrent long-term debt from the balance sheet per SEC EDGAR XBRL (LongTermDebtNoncurrent concept). FY2025 LT debt $40.87bn confirmed via EDGAR XBRL. FY2025 GAAP EPS $22.95 confirmed from quarterly sum (Q1 $3.06 + Q2 $6.29 + Q3 $6.21 + Q4 $7.39). FY2025 Adjusted EPS $24.21 per company press release. Dividend figures are approximate annual totals from quarterly payments.

Quarterly revenue (FY2025–Q1 2026, most recent first):

Quarter	Revenue	Operating EPS	GAAP EPS
Q1 2026	$19.8bn	$8.55	$8.26
Q4 2025	$19.3bn	$7.54	$7.39
Q3 2025	$17.6bn	$7.02	$6.21
Q2 2025	$15.56bn	$6.31	$6.29
Q1 2025	$12.73bn	$3.34	$3.06
FY2025 total	$65.2bn	$24.21	$22.95

Free cash flow and capital allocation. FCF was $8.97bn in FY2025 (operating cash flow $16.81bn minus capital expenditures $7.84bn, per EDGAR XBRL). This represents a significant improvement from FY2024 FCF of $3.76bn (OCF $8.82bn minus capex $5.06bn) and FY2023 FCF of $0.79bn (OCF $4.24bn minus capex $3.45bn), which reflected the peak capex build-out phase. Capex is expected to remain elevated ($7–9bn annually) through the manufacturing expansion programme. Cash and equivalents stood at approximately $7.3bn at FY2025 year-end, against $40.87bn in noncurrent long-term debt — a net debt position reflecting the bond-funded manufacturing programme. LLY has maintained its dividend, paying $1.43 per quarter ($5.72/year) in FY2025, representing a modest yield of ~0.5% at current valuations.

Share count. Diluted weighted average shares were approximately 897–900 million for FY2025. Lilly has not pursued aggressive buybacks; capital is being directed to manufacturing expansion and R&D rather than capital returns. The diluted share count has been broadly flat over the five-year period.

6. Valuation & Market Data

Raw metrics, May 2026. Not opinions on whether the stock is cheap or expensive.

Metric	Value
Market cap	~$951bn (May 2026, per web search)
Enterprise value	~$987bn (market cap + $40.87bn LT debt − ~$7.3bn cash)
Trailing P/E (GAAP)	~46.0x (price ~$1,058 / FY2025 GAAP EPS $22.95)
P/E (forward)	~26.7x (per web search, May 2026, based on consensus non-GAAP estimates)
P/S (TTM)	~14.6x ($951bn / $65.2bn FY2025 revenue, per web search May 2026)
EV/EBITDA (TTM)	~35x (EV ~$987bn / estimated EBITDA ~$28bn)
P/FCF	~106x ($951bn / $8.97bn FY2025 FCF)
52-week high	$1,133.95
52-week low	$623.78
Dividend yield	~0.54% ($5.72 annual dividend at ~$1,058/share)
Short interest (% of float)	~0.87% (per web search, May 2026)
Days to cover	~1–2 days (low short interest, high liquidity)

Note: EBITDA estimated as GAAP net income ~$20.6bn + D&A ~$2.0bn (per EDGAR XBRL) + estimated interest expense ~$1.6bn + estimated income tax ~$4bn. EV/EBITDA is an approximation; use company-reported EBITDA when available. Forward P/E is based on consensus non-GAAP estimates per web search and will move with revisions to FY2026 guidance. Short interest sourced from web search May 2026.

7. What Are They Building / What's Coming?

Oral GLP-1 — Foundayo (orforglipron) launched April 2026. Lilly became one of the first companies to bring an oral small-molecule GLP-1 receptor agonist to market, with Foundayo approved by the FDA for type 2 diabetes in April 2026. Unlike injectable GLP-1s, orforglipron is a once-daily oral tablet, removing the injection barrier for many patients. Clinical trial data showed HbA1c reductions comparable to injectable GLP-1 analogues, though with lower absolute weight-loss efficacy than injectable tirzepatide. Oral tirzepatide (OFORLA programme) is also in development and, if approved, would offer the GIP/GLP-1 dual mechanism in pill form.

Retatrutide — triple agonist in Phase 3. Retatrutide (GIP/GLP-1/glucagon triple receptor agonist) has demonstrated weight-loss outcomes of up to 24% body weight reduction in Phase 2 trials — potentially exceeding tirzepatide in efficacy. Phase 3 trials (TRIUMPH programme) are underway in obesity and type 2 diabetes. If approved, retatrutide would represent the next generation of Lilly's incretin franchise and extend patent-protected revenue beyond the tirzepatide cycle.

Kisunla (donanemab) — Alzheimer's disease. Donanemab received FDA approval in July 2024 as Kisunla for the treatment of early symptomatic Alzheimer's disease in adults with amyloid pathology. Kisunla targets amyloid plaques and demonstrated a 35% slowing of cognitive decline in the TRAILBLAZER-ALZ 2 Phase 3 trial. Commercial uptake has been gradual given diagnostic complexity and infusion requirements, but management has guided that Kisunla represents a significant long-term revenue opportunity as the Alzheimer's market develops.

Manufacturing expansion. Lilly has committed over $23bn in US manufacturing investment since 2023, spanning new facilities in Indiana (Lebanon), North Carolina (Concord), and international sites in Germany and Ireland. On 6 May 2026, the company announced a further $4.5bn expansion of its Indiana manufacturing campus — the third major investment announcement for that site. These investments are aimed at scaling injectable and oral GLP-1 manufacturing to meet projected demand for Mounjaro, Zepbound, Foundayo, and future pipeline products.

Pipeline breadth. Beyond incretin biology, Lilly has 50+ molecules in clinical development including: lepodisiran (small interfering RNA targeting Lp(a) for cardiovascular disease, Phase 3), lebrikizumab/Ebglyss (atopic dermatitis, expanding internationally after EU and UK approvals), pirtobrutinib/Jaypirca (B-cell malignancies, growing oncology franchise), and multiple early-stage programmes in immunology and neurodegeneration. Management has guided that new pipeline molecules are expected to contribute materially to revenue in the 2027–2032 window.

FY2026 guidance. At the Q1 2026 earnings call (April 2026), management raised FY2026 revenue guidance to $82–85bn, implying growth of approximately 26–30% YoY. Non-GAAP EPS guidance was revised upward, reflecting manufacturing capacity increasing ahead of schedule at several new Indiana sites.

8. Competitive Landscape

The incretin (GLP-1/GIP) market is the most consequential growth market in global pharmaceuticals. Lilly competes primarily against Novo Nordisk in the diabetes and obesity segments, and against a broader set of large-cap pharmaceutical companies in oncology, immunology, and neuroscience.

GLP-1/incretin competition. Novo Nordisk's semaglutide (Ozempic for diabetes, Wegovy for obesity) is the primary competitor to tirzepatide. While tirzepatide has demonstrated superior weight-loss outcomes in head-to-head trials, semaglutide has strong physician familiarity, a first-mover advantage in obesity, and a maturing oral form (Rybelsus). Long-term, the competition will be defined by outcomes data in cardiovascular risk reduction (Mounjaro's SURPASS-CVOT), kidney disease, and non-alcoholic steatohepatitis (NASH). Other emerging GLP-1 challengers include Viking Therapeutics (VK2735, Phase 3), Roche (CT-388 and CT-996), Amgen (MariTide), and Structure Therapeutics — all at earlier stages but potentially entering market 2027–2029.

Oncology competition. Verzenio (abemaciclib) competes with Pfizer's Ibrance (palbociclib) and Novartis's Kisqali (ribociclib) in CDK4/6 inhibitors for breast cancer. Verzenio has differentiated itself via adjuvant data in early-stage high-risk breast cancer, making it the preferred agent in that sub-setting.

Policy impact. The Inflation Reduction Act's Medicare drug price negotiation provisions are a direct competitive factor. Both Lilly and Novo Nordisk face potential government-negotiated price reductions on their GLP-1 drugs for Medicare Part D patients. Novo Nordisk faces the same risk with semaglutide. Companies with lower US revenue concentration in Medicare populations face less acute exposure. Government subsidies are not a material factor in this sector beyond the Medicare/Medicaid reimbursement system and the patent protection framework.

Peer	Market Cap (May 2026)	FY2025 Revenue	P/E (TTM, May 2026)	Key differentiator
Novo Nordisk (NVO)	~$340bn (per web search May 2026)	DKK 232.3bn / ~$34bn (per FY2024 annual report; FY2025 est. ~$40bn)	~25x	Ozempic/Wegovy (semaglutide, GLP-1 pioneer); first-mover in obesity; oral semaglutide (Rybelsus). Primary GLP-1 rival; tirzepatide head-to-head shows Lilly's weight-loss superiority but Novo has deeper market penetration in obesity.
Pfizer (PFE)	~$135bn (per web search May 2026)	~$63bn (per FY2025 press release)	~12x	Broad diversified pharma including oncology (Ibrance), vaccines, and generics; no major GLP-1 presence. Significantly lower valuation reflects post-COVID portfolio normalisation and patent cliff concerns.
AstraZeneca (AZN)	~$275bn (per web search May 2026)	~$54bn (per FY2025 results)	~25x	Oncology-led (Tagrisso, Lynparza, Enhertu collaboration) and cardiovascular/metabolic (Farxiga). No GLP-1 franchise; differentiated by oncology breadth.
Merck (MRK)	~$260bn (per web search May 2026)	~$64bn (per FY2025 annual report)	~14x	Keytruda (pembrolizumab) is the world's best-selling drug by revenue; Gardasil HPV vaccine. Keytruda's patent cliff ~2028–2029 is a key risk; no GLP-1 exposure.
Johnson & Johnson (JNJ)	~$400bn (per web search May 2026)	~$90bn (per FY2025 annual report; pharma + MedTech)	~15x	Diversified pharmaceutical and MedTech; oncology (Darzalex, Erleada), immunology (Stelara, Tremfya). No GLP-1 programme; lower growth multiple reflects portfolio maturity.

9. Leadership and Ownership

David A. Ricks — Chairman and CEO. Ricks joined Lilly in 1996 and became President and CEO in January 2017, adding the Chairman role in 2018. Prior to becoming CEO, he led Lilly's international operations and its biomedicines division. Under his leadership, Lilly has transformed from a mid-sized diabetes company into the world's most valuable pharmaceutical company, principally driven by the strategic bet on tirzepatide and GLP-1 biology. He has presided over the largest manufacturing investment in Lilly's history.

Board and governance. Lilly's board includes directors with backgrounds in healthcare, technology, and finance. The company has a classified board structure; director backgrounds and committee assignments are listed in the most recent proxy statement at investor.lilly.com. Institutional Shareholder Services (ISS) and Glass Lewis governance ratings should be consulted by investors concerned with governance quality.

Insider ownership. Executive insider ownership is relatively modest as a percentage of total market cap given Lilly's ~$951bn size. David Ricks's beneficial ownership is below 1% of total shares. Management compensation is primarily performance-based (RSUs and PSUs tied to revenue and EPS milestones), aligning incentives with shareholders.

Institutional holders. Major institutional shareholders include Vanguard Group (~8%), BlackRock (~6%), State Street Corporation (~4%), and Capital Research and Management (~3%), per web search May 2026. These are approximate figures and change quarterly with 13F filings.

Insider transactions.

No material discretionary open-market purchases found in SEC Form 4 filings for the past 12 months. Most insider transactions during this period were pre-planned 10b5-1 programme disposals by executives exercising vested options and RSUs. Check SEC EDGAR Form 4 filings at sec.gov/cgi-bin/browse-edgar for LLY for current data.

Name	Date	Type	Shares	Price	Value	Plan type
No material discretionary insider transactions identified in SEC Form 4 search for LLY (past 12 months). Routine 10b5-1 plan disposals by executives occurred during the period; see sec.gov EDGAR for complete filings.

10. Risks and Challenges

• IRA Medicare price negotiation (Regulatory): Under the Inflation Reduction Act, the US Department of Health and Human Services can negotiate prices for high-spend Medicare Part D drugs. Tirzepatide (Mounjaro/Zepbound) is a candidate for future negotiation cycles, which could reduce US net realised prices for Medicare patients — a significant revenue risk given the US-heavy tirzepatide revenue base.
• GLP-1 competitive intensification (Competitive): Novo Nordisk's semaglutide franchise, plus advancing oral GLP-1 candidates from Roche (CT-388), Viking Therapeutics (VK2735), Amgen (MariTide), and others, threaten tirzepatide's long-term pricing power and market share. If a competitor achieves superior efficacy or a more convenient dosing form, uptake could slow materially from current growth trajectories.
• Manufacturing execution risk (Operational): The $23bn+ US manufacturing expansion is the largest capital programme in Lilly's history. Construction delays, FDA inspection findings at new sites, or quality control failures could constrain supply and defer revenue recognition, particularly for new oral and injectable GLP-1 products.
• High valuation concentration risk (Financial): At P/FCF ~106x and EV/EBITDA ~35x, the valuation embeds substantial execution assumptions. A clinical failure in retatrutide or Kisunla, slower tirzepatide adoption, or a pricing event could lead to significant multiple compression even if the underlying business continues growing.
• Patent cliff (Financial): Tirzepatide's core US composition-of-matter patents expire approximately 2036. Beyond that date, biosimilar or generic competition would compress pricing materially. Lilly must sustain pipeline productivity to replace tirzepatide revenue. Verzenio faces CDK4/6 biosimilar competition from approximately 2027–2030 depending on jurisdiction.
• Clinical trial failure risk (Operational): Pharmaceutical R&D carries inherent failure risk at all stages. Retatrutide Phase 3 results, Kisunla real-world safety data, and oral tirzepatide bioavailability data are all material binary events. A Phase 3 failure in retatrutide, in particular, would remove a key long-term growth pillar.
• Geopolitical and tariff exposure (Macro): Proposed US tariffs on pharmaceutical imports could affect Lilly's manufacturing costs at its international sites (Germany, Ireland). Conversely, Lilly's US domestic manufacturing expansion positions it relatively well in a tariff environment versus peers with higher offshore manufacturing ratios.
• GAAP earnings quality (Financial): Acquired in-process R&D charges, amortisation of intangibles from acquisitions, and other non-recurring items create a persistent gap between GAAP and non-GAAP earnings. Investors should track both metrics; periods of heavy acquisition activity can significantly suppress GAAP results.
• Key person risk (Operational): David Ricks has led Lilly's strategic transformation since 2017. Succession planning, while standard in large-cap companies, is a factor given the importance of long-term capital allocation decisions in pharmaceutical R&D.

11. Recent Developments

• 06 May 2026 — $4.5bn additional Indiana manufacturing investment announced. Eli Lilly announced a further $4.5bn expansion of its Lebanon, Indiana manufacturing campus, building on prior announcements of $9bn+ for that site. The investment targets additional capacity for injectable and oral GLP-1 medicines, with construction expected to create thousands of construction-phase jobs. This brings Lilly's total US manufacturing commitment since 2020 to over $23bn.
• 30 Apr 2026 — Q1 2026 earnings: revenue $19.8bn, GAAP EPS $8.26. Lilly reported Q1 2026 revenue of $19.8bn (per company earnings release), exceeding prior guidance. Non-GAAP EPS was $8.55. Management raised FY2026 revenue guidance to $82–85bn and non-GAAP EPS guidance upward, citing stronger-than-expected demand for Mounjaro and Zepbound as supply constraints ease at new manufacturing sites.
• Apr 2026 — Foundayo (orforglipron) FDA approval and US launch. The FDA approved orforglipron (Foundayo) for the treatment of type 2 diabetes in adults, making it one of the first oral non-peptide GLP-1 receptor agonists to reach market. Lilly commenced the US commercial launch of Foundayo in April 2026, positioning it as a complement to the injectable tirzepatide franchise for patients preferring oral therapy.
• 11 Feb 2026 — FY2025 full-year results. Lilly reported FY2025 revenue of $65.2bn (up 44.8% YoY), GAAP net income ~$20.6bn, and diluted GAAP EPS of $22.95. Mounjaro and Zepbound were the primary growth drivers. The company announced an increase in the quarterly dividend to $1.50 per share (FY2026 rate), an increase from $1.43 in FY2025.
• Jul 2025 — Kisunla commercial rollout progressing. Following FDA approval in July 2024, Lilly's donanemab (Kisunla) continued its commercial rollout for early symptomatic Alzheimer's disease during 2025. Uptake has been gradual given requirements for amyloid PET or CSF testing to confirm eligibility; management acknowledged the diagnostic bottleneck but expressed confidence in long-term market development. Kisunla's TRAILBLAZER-ALZ 3 prevention trial continues.
• 2026 — 150th anniversary year. Eli Lilly marks its 150th year in operation in 2026, having been founded by Colonel Eli Lilly in Indianapolis on 10 May 1876. The company has commissioned commemorative activities and used the milestone in investor communications to highlight its long-term scientific heritage. For investor relations and regulatory filings, visit the ChartsView Forum or Economic Calendar.

12. Key Dates Coming Up

• Expected late July / early August 2026 — Q2 2026 earnings release and conference call (exact date to be confirmed at investor.lilly.com; typically 4–6 weeks after quarter end).
• Expected Aug 2026 — Ex-dividend date for Q3 2026 quarterly dividend (confirm exact date at investor.lilly.com/dividends).
• 2026 (ongoing) — Retatrutide Phase 3 TRIUMPH trial interim data readouts expected; management has guided on mid-to-late 2026 data milestones.
• 2026 (ongoing) — Oral tirzepatide Phase 3 trial data expected; positive results would be a major catalyst for the next generation of the tirzepatide franchise.
• 2027 (expected) — IRA-negotiated Medicare price for tirzepatide takes effect; the impact on net US revenue per unit is a key monitoring item.

Disclaimer: This research is produced by ChartsView for educational and informational purposes only. It does not constitute financial advice or a recommendation to buy or sell any security. All information is sourced from publicly available company filings, press releases, and official data. ChartsView does not use analyst opinions or third-party ratings. Always conduct your own due diligence and consider your personal financial situation before making investment decisions. Past performance is not indicative of future results.

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Gilead Sciences, Inc. (GILD) — Company Research

Last Updated: 16 May 2026

Gilead Sciences, Inc. is a Foster City, California biopharmaceutical company built on antiviral chemistry — its commercial portfolio of more than 25 therapies is anchored in HIV (Biktarvy, Descovy, Genvoya, Odefsey, Symtuza, Sunlenca, Yeztugo), liver disease (Epclusa, Livdelzi, Vemlidy), oncology cell therapy (Yescarta, Tecartus), antibody-drug conjugates (Trodelvy), COVID-19 (Veklury) and antifungals (AmBisome). Total revenue was $29,442m in fiscal 2025 (year ended 31 December 2025), with $23,208m of gross profit (78.83% gross margin per JSON), $10,022m of operating income, $8,510m of net income, $10,019m of operating cash flow and $9,456m of free cash flow. The shares closed the most recent session at $129.58 against a 52-week range of $102.84 to $157.29 — putting market capitalisation at approximately $160.9bn against an enterprise value of approximately $173.2bn. The $12.3bn gap reflects $24,936m of total debt and $22,129m of long-term debt (JSON) against $7,564m of cash and equivalents (JSON). The company carries a 2.53% indicated dividend yield (JSON) and is in the headlines this month on the early-May Q1 2026 release (recent_news 8–13 May 2026) which paired strong Biktarvy and Descovy growth with a sharply lowered adjusted-EPS guide on $11.5bn of IPR&D and financing charges tied to the pending Arcellx acquisition.

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1. Company Snapshot

| Field | Value | |---|---| | Company | Gilead Sciences, Inc. | | Ticker | GILD (NMS / Nasdaq Global Select) | | Sector / Industry | Healthcare / Drug Manufacturers — General | | Country | United States | | Headquarters | 333 Lakeside Drive, Foster City, California | | Website | https://www.gilead.com | | CEO | Mr. Daniel P. O'Day | | Employees (approx., 31 Dec 2025) | 17,000 | | Market capitalisation | ~$160.9 billion | | Enterprise value | ~$173.2 billion | | Shares outstanding | 1,241,569,874 | | Float | 1,238,826,005 | | Latest annual revenue (FY2025, ended 31 Dec 2025) | $29,442m | | Latest annual net income (FY2025) | $8,510m | | Cash & equivalents (31 Dec 2025) | $7,564m | | CIK | 0000882095 |

Per the FY2025 10-K (Item 1, filed 2026-02-24): Gilead "is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades" and "operate[s] in more than 35 countries worldwide, with headquarters in Foster City, California." Therapeutic focus is on "virology, oncology and inflammation." As of 31 December 2025, the company "had approximately 17,000 employees."

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2. Bull Case vs Bear Case

Bull case

• HIV franchise grew through Medicare Part D headwinds: per the FY2025 10-K (Item 7, filed 2026-02-24), HIV product sales rose 6% to $20.8bn in 2025, with Biktarvy up 7% to $14,334m and Descovy up 31% to $2,758m on "higher demand, including patients switching from Genvoya and other Gilead HIV products" and "higher demand and average realized price" respectively.
• Yeztugo (lenacapavir) PrEP launch is on track and now carries a CDC recommendation: per the FY2025 10-K (Item 7, filed 2026-02-24), "FDA granted approval for Yeztugo for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35kg" and Yeytuo received EC marketing authorisation in the EU. Recent news (8 May 2026, MT Newswires) confirms management has "raised Yeztugo guidance for 2026 to $1 billion from $800 million." Patent protection runs to 2037 in both the U.S. and EU (per the FY2025 10-K, Item 1, filed 2026-02-24).
• Biktarvy patent runway materially extended: per the FY2025 10-K (Item 7, filed 2026-02-24), October 2025 settlements with Lupin, Cipla and Laurus Labs mean "the earliest date the three generic manufacturers can market a generic version of full dose Biktarvy in the U.S. is April 1, 2036, subject to standard acceleration provisions. This is more than two years later than our previous loss of exclusivity projection for Biktarvy (December 2033)."
• Massive U.S. capital commitment underwrites onshoring exposure: per the FY2025 10-K (Item 7, filed 2026-02-24), ground broke on a "new Pharmaceutical Development and Manufacturing Technical Development Center in Foster City, California as part of a planned $32 billion investment in the U.S. through 2030."
• Capital return discipline maintained while debt was repaid: JSON-sourced FY2025 metrics show $4,003m of dividends paid (a 2.53% indicated yield per JSON) and $1,922m of buybacks, even as $1.8bn of senior notes was repaid (per the FY2025 10-K, Item 7, filed 2026-02-24). A $0.82 quarterly dividend was declared on 10 February 2026 with a 30 March 2026 pay date (per the FY2025 10-K, Item 7, filed 2026-02-24).
• Cash generation is robust: JSON FY2025 OCF $10,019m and FCF $9,456m on revenue of $29,442m — a 32.1% free-cash-flow margin — funded the dividend, buyback and debt-reduction programme without drawing on the $2.5bn revolving credit facility (per the FY2025 10-K, Item 7, filed 2026-02-24).

Bear case

• Headline 2026 outlook turned sharply negative on acquisition charges: recent news (11 May 2026, Insider Monkey) reports that "GILD revised its fiscal 2026 outlook, now expecting adjusted earnings per share between a loss of $1.05 and a loss [...]" tied to "$11.5B IPR&D and Financing Costs" associated with pending strategic transactions.
• IPR&D impairment risk on Hep-D pipeline: per the FY2025 10-K (Item 7, filed 2026-02-24), Gilead recognised partial bulevirtide IPR&D impairment charges of "$190 million and $400 million in In-process research and development impairments on our Consolidated Statements of Operations for the second and fourth quarters of 2025, respectively, for a total of $590 million for the year ended December 31, 2025" after competitive clinical data appeared in HDV. Bulevirtide's BLA in the U.S. is still pending (per the FY2025 10-K, Item 1, filed 2026-02-24).
• Oncology cell therapy is in decline: per the FY2025 10-K (Item 7, filed 2026-02-24), "Cell Therapy product sales decreased 7% to $1.8 billion in 2025, compared to 2024, primarily due to lower demand reflecting ongoing competitive headwinds." Yescarta fell 5% to $1,495m and Tecartus fell 15% to $344m.
• Pipeline setbacks in 2025 across oncology: per the FY2025 10-K (Item 7, filed 2026-02-24), the Phase 3 STAR-221 study of domvanalimab + zimberelimab (in partnership with Arcus) was discontinued; the Phase 3 ASCENT-07 study of Trodelvy as 1L post-endocrine in HR+/HER2- mBC "did not meet the primary endpoint of progression-free survival"; and FDA placed a clinical hold on the HIV treatment trials of GS-1720 and/or GS-4182 (WONDERS-1 and WONDERS-2).
• Veklury is a structurally declining contributor: per the FY2025 10-K (Item 7, filed 2026-02-24), Veklury sales "decreased 49% to $911 million in 2025, compared to 2024, primarily due to lower COVID-19-related hospitalizations." The same MD&A flags continued decline in the 2026 outlook.
• Medicare Part D redesign / U.S. pricing pressure is mechanical: per the FY2025 10-K (Item 7, filed 2026-02-24), gross-to-net deductions widened to 41% of gross product sales in 2025 versus 38% in 2024 (a 250-basis-point widening), and rebates and chargebacks rose from $15.5bn to $17.5bn — "primarily due to U.S. Medicare Part D program redesign impact."
• Wholesaler concentration: per the FY2025 10-K (Item 1, filed 2026-02-24), "approximately 90% of our gross product sales in the U.S. have been to three large wholesalers — Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation."
• Capital structure remains levered: JSON shows $24,936m of total debt against $22,702m of total equity at 31 December 2025, a 1.0984x debt/equity ratio. Total long-term debt is $22,129m; interest expense was $1,024m in 2025 (JSON; +5% YoY per the FY2025 10-K, Item 7, filed 2026-02-24) "primarily due to higher debt balances and a higher weighted-average interest rate on the debt."

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3. What Does This Company Actually Do?

In plain English, Gilead develops and sells branded prescription medicines in HIV, viral hepatitis, oncology and a handful of other infectious-disease and inflammation indications, in roughly 35 countries. Most of its profit comes from a small number of HIV single-tablet regimens — Biktarvy in particular — supplemented by hepatitis C/B/D, COVID-19 (Veklury, in decline), the CAR-T cell therapies Yescarta and Tecartus, and the antibody-drug conjugate Trodelvy. The company does not report a multi-segment P&L; the disaggregation provided is by product family and by region.

Product sales by family (FY2025, % of total revenues of $29,443m) — per the FY2025 10-K (Item 7, filed 2026-02-24):

• HIV — total — $20,752m, ~70.5% of total revenues (+6% YoY):
• Biktarvy — $14,334m, ~48.7% (+7% YoY).
• Descovy — $2,758m, ~9.4% (+31% YoY).
• Genvoya — $1,498m, ~5.1% (-15% YoY).
• Odefsey — $1,167m, ~4.0% (-9% YoY).
• Symtuza (revenue share) — $495m, ~1.7% (-16% YoY).
• Other HIV (incl. Atripla, Complera/Eviplera, Emtriva, Stribild, Sunlenca, Truvada, Tybost, Yeztugo/Yeytuo) — $500m, ~1.7% (+15% YoY).
• Liver Disease — total — $3,217m, ~10.9% (+6% YoY):
• Sofosbuvir/Velpatasvir (Epclusa + Asegua AG) — $1,272m, ~4.3% (-20% YoY).
• Vemlidy — $1,070m, ~3.6% (+12% YoY).
• Other Liver Disease (incl. Harvoni AG, Hepcludex, Hepsera, Livdelzi/Lyvdelzi, Sovaldi, Viread, Vosevi) — $874m, ~3.0% (+87% YoY).
• Veklury — $911m, ~3.1% (-49% YoY).
• Oncology — total — $3,236m, ~11.0% (-2% YoY):
• Cell Therapy (Yescarta + Tecartus) — $1,839m, ~6.2% (-7% YoY).
• Trodelvy — $1,397m, ~4.7% (+6% YoY).
• Other (AmBisome + Cayston/Jyseleca/Letairis/Zydelig) — $799m, ~2.7% (-10% YoY).
• Royalty, contract and other revenues — $527m, ~1.8% (vs $144m in 2024 — per the FY2025 10-K (Item 7, filed 2026-02-24), "primarily due to recognition of $400 million of previously constrained revenues from the sale of certain intellectual property").
• Total revenues — $29,443m (matches JSON to $1m rounding on $29,442m).

FY2025 Revenue HIV — 70.5% Liver Disease — 10.9% Oncology — 11.0% Veklury + Other + Royalty — 7.6%

Geographic split of total revenues (FY2025) — per the FY2025 10-K (Item 7, filed 2026-02-24):

• United States — $20,876m, ~70.9% of total revenues.
• Europe — $5,064m, ~17.2% of total revenues.
• Rest of World — $3,503m, ~11.9% of total revenues.
• Total revenues — $29,443m, 100%.

Customer concentration. Per the FY2025 10-K (Item 1, filed 2026-02-24): "approximately 90% of our gross product sales in the U.S. have been to three large wholesalers — Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation — and their specialty distributor affiliates."

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4. The Business Model

Gilead is a vertically integrated biopharmaceutical company that earns the bulk of its profit from a portfolio of patented antiviral, oncology and liver-disease medicines sold under price-controlled and rebated reimbursement frameworks. It designs, manufactures and distributes the majority of its commercial products in-house through its own plants in California (Foster City, La Verne, Oceanside, El Segundo, Santa Monica), Maryland (Frederick), Ireland (Cork, Dublin), Canada (Edmonton) and the Netherlands, supplemented by third-party contract manufacturers (per the FY2025 10-K, Item 1, filed 2026-02-24).

Margins. Headline gross margin was 78.83% in FY2025 (JSON), operating margin 34.04%, net margin 28.90%, ROE 37.49%, ROA 14.42% and FCF yield 5.88% (all JSON). The 10-K reports product-only gross margin (a different definition) of 78.4% (per the FY2025 10-K, Item 7, filed 2026-02-24) and notes it "remained relatively flat compared to 2024."

Operating cost stack. Per the FY2025 10-K (Item 7, filed 2026-02-24), FY2025 operating costs were:

• Cost of goods sold: $6,234m (matches JSON $6,234m); product gross margin 78.4% versus 78.2% in 2024.
• Research and development: $5,799m (-2% YoY) — Personnel/infrastructure/other support costs of $3,427m and clinical studies and other costs of $2,372m.
• Acquired in-process research and development (IPR&D): $1,024m in 2025 versus $4,663m in 2024 — the 2025 figure was driven primarily by the $311m Interius acquisition, $250m LEO Pharma collaboration upfront and $200m Pregene upfront/milestone payments.
• In-process research and development impairments: $590m in 2025 (bulevirtide partial impairments of $190m in Q2 and $400m in Q4) versus $4,180m in 2024 (Trodelvy NSCLC IPR&D writedown).
• Selling, general and administrative: $5,774m (-5% YoY) — selling and marketing $3,522m (+2%), general and administrative $2,252m (-15%).

Tax. Per the FY2025 10-K (Item 7, filed 2026-02-24): effective tax rate 13.1% in 2025 versus 30.5% in 2024, the latter inflated by the non-deductible CymaBay acquired-IPR&D expense. In October 2025 Gilead "reached a settlement with a tax authority related to a prior year legal entity restructuring," recognising approximately $450m of income tax benefit and a corresponding $530m reduction in unrecognized tax benefits in Q4 2025.

Subsidy / regulatory-credit dependency. Not material in the manner of an EV manufacturer or regulated utility. The Item 7 MD&A does, however, disclose two material public-policy interventions on the demand and supply side. Demand-side: per the FY2025 10-K (Item 7, filed 2026-02-24), gross-to-net deductions widened 250bps to 41% of gross product sales in 2025 on "U.S. Medicare Part D program redesign impact," with rebates and chargebacks rising from $15.5bn to $17.5bn. Supply-side: an "agreement with the U.S. government to lower the cost of medicines for Americans" and the $32bn U.S. investment commitment through 2030, including the new Foster City Pharmaceutical Development and Manufacturing Technical Development Center.

International / lenacapavir access. Per the FY2025 10-K (Item 7, filed 2026-02-24): Gilead "announced a partnership with the U.S. State Department and the U.S. President's Emergency Plan for AIDS Relief ('PEPFAR') to deliver lenacapavir for HIV PrEP for up to two million people over three years in countries supported by both PEPFAR and the Global Fund."

Capital model. Operating cash flow funds R&D, capex, dividends, buybacks and debt repayment. JSON-sourced FY2025 metrics: OCF $10,019m, capex $563m, FCF $9,456m, buybacks $1,922m, dividends paid $4,003m. Per the FY2025 10-K (Item 7, filed 2026-02-24): "In 2025, we utilized cash of $4.0 billion for dividend payments, $1.9 billion for common stock repurchases and $1.8 billion for repayment of debt." A $1.3bn final federal income tax payment for the TCJA mandatory deemed-repatriation transition tax was paid in 2025.

Foreign currency exposure. Per the FY2025 10-K (Item 7A, filed 2026-02-24): approximately 26% of 2025 product sales are denominated in foreign currencies (primarily the Euro). FX hedging is done via forward contracts with $3.9bn aggregate notional at year-end 2025 (versus $2.9bn at year-end 2024). A hypothetical 10% adverse FX move would reduce the fair value of those contracts by approximately $439m.

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5. Financial Health

Five-year P&L and balance-sheet trend (JSON is the source of truth for the line items below; FY2021 P&L lines are not populated in the JSON record beyond operating income).

| Fiscal year ended | Revenue | Operating income | Net income | Diluted EPS | Diluted shares (m) | Cash & equivs | Total debt | Total equity | Operating cash flow | Free cash flow | Dividends paid | |---|---|---|---|---|---|---|---|---|---|---|---| | 31 Dec 2025 (FY2025) | $29,442m | $10,022m | $8,510m | $6.78 | 1,255 | $7,564m | $24,936m | $22,702m | $10,019m | $9,456m | $4,003m | | 31 Dec 2024 (FY2024) | $28,754m | $1,662m | $480m | $0.38 | 1,255 | $9,991m | $26,711m | $19,330m | $10,828m | $10,305m | $3,918m | | 31 Dec 2023 (FY2023) | $27,116m | $7,605m | $5,665m | $4.50 | 1,258 | $6,085m | $24,987m | $22,833m | $8,006m | $7,421m | $3,809m | | 31 Dec 2022 (FY2022) | $27,281m | $7,330m | $4,592m | $3.64 | 1,262 | $5,412m | $25,230m | $21,240m | $9,072m | $8,344m | $3,709m | | 31 Dec 2021 (FY2021) | not in JSON | $9,918m | not in JSON | not in JSON | n/a | n/a | n/a | n/a | n/a | n/a | n/a |

The four-year arc shows revenue stepping up from $27,281m (FY2022) to $27,116m (FY2023, -0.6%) to $28,754m (FY2024, +6.0%) to $29,442m (FY2025, +2.39% per JSON). Reported operating income oscillates wildly across the window because of acquisition-related accounting: FY2024's $1,662m operating-income figure (JSON) was depressed by the $3.8bn non-deductible IPR&D charge for CymaBay and the $4.2bn Trodelvy NSCLC IPR&D impairment booked the same year, both of which dropped out in FY2025 — per the FY2025 10-K (Item 7, filed 2026-02-24), the FY2025 net income recovery to $8,510m versus $480m in 2024 reflects "A $3.8 billion acquired in-process research and development ('IPR&D') expense related to the acquisition of CymaBay Therapeutics, Inc. ('CymaBay') in 2024, which did not repeat in 2025" together with "Lower pre-tax IPR&D partial impairment charges, with $590 million in 2025 related to assets acquired from MYR GmbH ('MYR') compared to $4.2 billion in 2024 related to assets acquired from Immunomedics, Inc." Diluted share count edged down from 1,262m (FY2022) to 1,255m (FY2025) as buybacks of roughly $1.0bn–$1.9bn per year approximately offset stock-based compensation.

Quarterly trajectory (JSON; gross margin computed from gross profit ÷ revenue).

| Quarter end | Revenue | Gross profit | Gross margin | Operating income | Net income | EPS (diluted) | Operating cash flow | Free cash flow | |---|---|---|---|---|---|---|---|---| | 31 Dec 2025 (FY25 Q4) | $7,924m | $6,300m | 79.51% | $2,988m | $2,183m | $1.74 | $3,327m | $3,122m | | 30 Sep 2025 (FY25 Q3) | $7,769m | $6,200m | 79.81% | $3,497m | $3,052m | $2.43 | $4,108m | $3,961m | | 30 Jun 2025 (FY25 Q2) | $7,081m | $5,580m | 78.80% | $2,724m | $1,960m | $1.56 | $827m | $720m | | 31 Mar 2025 (FY25 Q1) | $6,667m | $5,127m | 76.90% | $2,490m | $1,315m | $1.04 | $1,757m | $1,653m | | 31 Dec 2024 (FY24 Q4) | $7,569m | $5,988m | 79.11% | $2,440m | $1,783m | $1.42 | $2,975m | $2,828m |

0 2.5 5.0 7.5 10

0% 25% 50% 75% 100%

$7.57

$6.67

$7.08

$7.77

$7.92

Q4 24 Q1 25 Q2 25 Q3 25 Q4 25

Revenue ($bn) Gross Margin (%)

Revenue Gross Margin

The quarterly trail shows Gilead's classic Q1-low seasonality on the U.S. drug-pricing cycle: Q1 2025 was $6.667m, the weakest quarter in the window, with sequential improvement to $7.924m in Q4 2025. Gross margin stayed in a tight 76.9%–79.8% band across all five quarters.

Liquidity, debt and capital structure. Per the FY2025 10-K (Item 7 and Item 7A, filed 2026-02-24):

• Cash and cash equivalents: $7.6bn at 31 December 2025 (matches JSON $7,564m), plus marketable debt securities of $3.0bn.
• Total debt (JSON): $24,936m, of which long-term $22,129m and short-term $2,807m (derived). The 10-K's Item 7A reference values quote "$22.3 billion" fair value for the senior unsecured notes and "$0.8 billion" for the Immunomedics-related future-royalties liability.
• Senior unsecured notes: fixed-rate, no interest-rate exposure on coupons; fair value sensitive to rate movements.
• Revolving credit facility: $2.5bn, maturing June 2029; nothing drawn at 31 December 2025.
• FX forward contracts notional: $3.9bn at year-end 2025 (vs $2.9bn at year-end 2024).
• Equity securities held in connection with collaborations (Arcus, Galapagos, Arcellx, etc.): fair value approximately $2.0bn at 31 December 2025 (vs $1.6bn at year-end 2024).

Cash flow. Per the FY2025 10-K (Item 7, filed 2026-02-24): net cash provided by operating activities of $10,019m in FY2025 (vs $10,828m FY2024); net cash used in investing of $(4,793)m (vs $(3,449)m FY2024) — driven by purchases of marketable debt securities and payments related to the Interius acquisition and various collaborations; net cash used in financing of $(7,745)m (vs $(3,433)m FY2024) — driven by $4.0bn dividends, $1.9bn buybacks and $1.8bn debt repayment.

Capital return — buybacks. JSON-sourced FY2025 buybacks were $1,922m (vs $1,150m FY2024). Per the FY2025 10-K (Item 7, filed 2026-02-24): "higher common stock repurchases" was one of the drivers of the larger 2025 financing-activity cash outflow.

Capital return — dividends. JSON-sourced dividends paid: $4,003m FY2025, $3,918m FY2024, $3,809m FY2023, $3,709m FY2022. Per the FY2025 10-K (Item 7, filed 2026-02-24): "On February 10, 2026, we announced that our Board of Directors declared a quarterly dividend of $0.82 per share of our common stock, with a payment date of March 30, 2026 to all stockholders of record as of the close of business on March 13, 2026."

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6. Valuation & Market Data

| Metric | Value | Source / note | |---|---|---| | Share price | $129.58 | JSON, as of 2026-05-16T05:00:11Z | | Previous close | $132.06 | JSON | | Day open / high / low | $132.27 / $132.805 / $129.095 | JSON | | Daily volume | 6,637,711 | JSON | | 10-day average volume | 6,679,580 | JSON | | 52-week high | $157.29 | JSON | | 52-week low | $102.84 | JSON | | Market capitalisation | $160,882,638,848 (~$160.9 billion) | JSON | | Enterprise value | $173,155,631,104 (~$173.2 billion) | JSON | | Shares outstanding | 1,241,569,874 | JSON | | Float | 1,238,826,005 | JSON | | Beta | 0.332 | JSON | | P/E (trailing, calculated) | 19.1121 | JSON; current_price / latest_diluted_eps ($129.58 / $6.78) | | Trailing P/E (yfinance variant) | 17.6299 | JSON price.trailing_pe_yfinance | | Forward P/E (yfinance variant) | 13.4763 | JSON price.forward_pe_yfinance | | P/B | 7.0867 | JSON | | P/S (trailing) | 5.4644 | JSON | | EV / Revenue | 5.8812 | JSON | | EV / EBITDA proxy | 17.2776 | JSON; D&A unavailable in source data — JSON uses operating income as a proxy denominator and labels this as a proxy in _calc_notes | | FCF yield | 5.88% | JSON; FCF / market cap | | Gross margin | 78.83% | JSON | | Operating margin | 34.04% | JSON | | Net margin | 28.90% | JSON | | ROE | 37.49% | JSON | | ROA | 14.42% | JSON | | Debt / equity | 1.0984 | JSON | | Current ratio | 1.5527 | JSON | | Dividend yield (indicated) | 2.53% | JSON | | Short interest / put-call / days-to-cover | not disclosed in this report's source data | JSON does not carry these fields |

ChartsView publishes raw numbers only and does not editorialise on whether these levels look cheap or expensive. The JSON-calculated trailing P/E of 19.11 (computed from price ÷ FY2025 diluted EPS) and the yfinance-sourced trailing P/E of 17.63 are not identical because of different EPS conventions (FY-period diluted EPS versus a yfinance trailing-twelve-month diluted EPS); both are shown for transparency. The forward P/E of 13.48 reflects analyst-consensus EPS estimates embedded in yfinance and is shown for transparency only — note that recent news (11 May 2026, Insider Monkey) reports a sharply lowered fiscal 2026 adjusted-EPS guide tied to pending acquisition charges, which is not yet reflected in any consensus forward number.

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7. What Are They Building / What's Coming?

Late-stage pipeline (Phase 3 / pending regulatory review) — per the FY2025 10-K (Item 1, filed 2026-02-24):

• Bulevirtide — Biologics License Application (BLA) filed with FDA for chronic hepatitis delta virus (HDV) infection; granted both Orphan Drug and Breakthrough Therapy designations. Q2 and Q4 2025 partial IPR&D impairments totaling $590m followed competitive HDV data (per the FY2025 10-K, Item 7, filed 2026-02-24).
• Lenacapavir, once-yearly injection for HIV PrEP — Phase 3 in development.
• Bictegravir and lenacapavir (BIC/LEN), oral combination — Phase 3 in development as HIV treatment. Per the FY2025 10-K (Item 7, filed 2026-02-24): "Announced positive topline Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trial … BIC/LEN met its primary endpoint, demonstrating non-inferiority to baseline multi-tablet antiviral regimens (ARTISTRY-1) and Biktarvy (ARTISTRY-2)."
• Islatravir and lenacapavir, oral combination (in collaboration with Merck) — long-acting HIV treatment for virologically suppressed patients.
• Anitocabtagene autoleucel (in collaboration with Arcellx) — BLA filed with FDA, BCMA-directed CAR T-cell therapy for relapsed/refractory multiple myeloma after ≥3 prior systemic regimens. Per the FY2025 10-K (Item 7, filed 2026-02-24): "Announced that we entered into a definitive agreement to acquire all of the outstanding common stock of Arcellx, Inc. … This transaction is anticipated to close during the second quarter of 2026."
• Sacituzumab govitecan-hziy (Trodelvy) — supplemental BLA for 1L PD-L1 negative metastatic TNBC; a parallel sBLA with Merck's pembrolizumab for 1L PD-L1 positive metastatic TNBC.
• Axicabtagene ciloleucel (Yescarta) — Phase 3 for 2L FL and 1L LBCL high-risk patients.
• Anitocabtagene autoleucel — Phase 3 in 1L–3L multiple myeloma.
• Sacituzumab govitecan-hziy and combinations — Phase 3 across high-risk adjuvant TNBC, extensive-stage small cell lung cancer, 1L PD-L1 positive metastatic NSCLC (with Merck), and 2L metastatic endometrial cancer.
• Domvanalimab and zimberelimab (in collaboration with Arcus) — Phase 3 anti-TIGIT + anti-PD-1 + chemo for 1L metastatic NSCLC. Per the FY2025 10-K (Item 7, filed 2026-02-24): the parallel Phase 3 STAR-221 trial in 1L HER2- advanced gastric/esophageal cancer was discontinued in 2025 on Independent Data Monitoring Committee recommendation, and the Phase 2 EDGE-Gastric study in upper GI cancers was also discontinued.

2025 regulatory approvals — per the FY2025 10-K (Item 1, filed 2026-02-24):

• Yeztugo / Yeytuo (lenacapavir for PrEP) — FDA approval as "the first and only twice-yearly option available in the United States for people who need or want PrEP" for adults and adolescents weighing ≥35kg; European Commission also granted marketing authorisation for Yeytuo. Per the FY2025 10-K (Item 7, filed 2026-02-24): "Received a strong recommendation for the use of twice-yearly injectable Yeztugo (lenacapavir) for HIV PrEP in the new U.S. Centers for Disease Control and Prevention guidelines."
• Lyvdelzi (seladelpar) — EC conditional marketing authorisation for primary biliary cholangitis (PBC) in combination with UDCA, or as monotherapy in patients unable to tolerate UDCA.

Selected 2025 / early-2026 business-development activity — per the FY2025 10-K (Item 7, filed 2026-02-24):

• Arcellx acquisition — definitive agreement to acquire all outstanding stock; close anticipated Q2 2026; provides full control of anitocabtagene autoleucel.
• Interius BioTherapeutics — acquisition completed for approximately $350m; in vivo CAR therapeutics platform.
• LEO Pharma — strategic partnership "to develop and commercialize their pre-clinical oral signal transducer and activator of transcription 6 programs for the potential treatment of inflammatory diseases"; $250m upfront in 2025.
• Pregene — collaboration to develop next-generation in vivo therapies; $200m upfront/milestone payments in 2025.
• Kymera Therapeutics — exclusive option and license agreement "to develop novel oral molecular glue CDK2 degraders with broad oncology treatment potential."

Manufacturing build-out. Per the FY2025 10-K (Item 7, filed 2026-02-24): ground broke on a "new Pharmaceutical Development and Manufacturing Technical Development Center in Foster City, California as part of a planned $32 billion investment in the U.S. through 2030." Existing in-house manufacturing footprint (per Item 1) spans Foster City, La Verne, Oceanside, El Segundo, Santa Monica (all California), Frederick (Maryland), Cork and Dublin (Ireland), Edmonton (Canada) and the Netherlands.

Patent runway (per the FY2025 10-K, Item 1, filed 2026-02-24) — U.S. / EU primary-compound expiries for principal commercial products and product candidates:

• Biktarvy — 2036 (U.S.) / 2033 (EU). October 2025 settlements with Lupin, Cipla and Laurus Labs lifted the earliest U.S. generic entry date for full-dose Biktarvy from December 2033 to April 1, 2036.
• Descovy — 2031 / 2027.
• Vemlidy — 2031 / 2027.
• Odefsey — 2032 / 2027.
• Genvoya — 2029 / 2028 (February 2025 Apotex/MSN agreement provides a non-exclusive license beginning August 6, 2032, or earlier in certain circumstances).
• Yescarta — 2031 / — (composition of matter patent has expired in the EU; manufacturing-process applications pending).
• Epclusa — 2033 / 2032.
• Veklury — 2036 / 2035 (extended by January 2024 FDA pediatric exclusivity).
• Tecartus — 2027 / — (EU composition of matter expired).
• Trodelvy (sacituzumab govitecan-hziy) — 2028 / 2029 (U.S. regulatory exclusivity to 2032).
• Sunlenca — 2037 / 2037.
• Livdelzi / Lyvdelzi — 2025 / — (U.S. FDA Orphan Drug Exclusivity to 2031; EU 10-year regulatory/market exclusivity expected on approval).
• Yeztugo / Yeytuo — 2037 / 2037.
• Lenacapavir (pipeline) — 2037 / 2037.
• Bulevirtide (pipeline) — 2030 / 2029.
• Anitocabtagene autoleucel (with Arcellx) — 2038 / (2038, pending).
• Zimberelimab (with Arcus) — 2036 / 2036.
• Domvanalimab (with Arcus) — 2037 / (2037, pending).

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8. Competitive Landscape

Gilead does not quote market-share percentages for its products in the Item 1 disclosures reviewed. Per the FY2025 10-K (Item 1, filed 2026-02-24): "We operate in a highly competitive environment. Our products compete with other commercially available products based primarily on efficacy, safety, tolerability, acceptance by doctors, ease of patient compliance, ease of use, price, insurance and other reimbursement coverage, distribution and marketing." Gilead also faces "significant competition from: (i) large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies to pursue the development of products and technologies that may be competitive with our existing products or research programs; (ii) academic institutions, government agencies and other public and private organizations conducting research who may seek patent protection or may establish collaborative arrangements for competitive products or programs; (iii) pricing pressures from private insurers and government payers as our products mature, which often result in a reduction of our net product prices; and (iv) new branded or generic products introduced into major markets, which may impact our ability to maintain pricing and market share."

The 10-K does name several collaboration and adjacent-area counterparties from which competitive context can be inferred for the HIV, oncology and inflammation franchises. The list below paraphrases qualitative competitor framing from the FY2025 10-K (Item 1, filed 2026-02-24) and from the JSON company.description field — it is not a list of named market-share percentages because none are quoted in the source data.

| Gilead franchise | Major competitor product(s) | Competitor company | |---|---|---| | HIV — single-tablet regimens & treatment | Dovato, Tivicay, Cabenuva | GSK plc / ViiV Healthcare | | HIV — single-tablet regimens & treatment | Pifeltro / DELSTRIGO | Merck & Co., Inc. | | HIV — PrEP (oral) | Apretude (long-acting cabotegravir) | GSK plc / ViiV Healthcare | | Liver — chronic HCV | Mavyret | AbbVie Inc. | | Liver — PBC | OCALIVA | Intercept Pharmaceuticals (Alfasigma) | | Oncology — CAR-T (LBCL/FL/MCL/MM) | Breyanzi, Abecma | Bristol Myers Squibb (legacy Celgene) | | Oncology — CAR-T (LBCL/FL) | Kymriah | Novartis AG | | Oncology — CAR-T (multiple myeloma, BCMA) | Carvykti | Johnson & Johnson Innovative Medicine / Legend Biotech | | Oncology — TNBC, breast | Keytruda (combo standard of care) | Merck & Co., Inc. | | Oncology — TNBC ADC | Enhertu | AstraZeneca / Daiichi Sankyo | | COVID-19 antivirals | Paxlovid | Pfizer Inc. | | COVID-19 antivirals | Lagevrio (molnupiravir) | Merck & Co., Inc. | | Antifungal (AmBisome) | Generic liposomal amphotericin B | Various |

A competitor-share chart with named percentage shares is not produced for this article: the FY2025 10-K does not quote market-share percentages for Gilead or its named competitors in the sections reviewed (Item 1, Item 7), and inserting external estimates would breach the source-data discipline applied to this report.

Wholesaler concentration on the U.S. distribution side. Per the FY2025 10-K (Item 1, filed 2026-02-24): "approximately 90% of our gross product sales in the U.S. have been to three large wholesalers — Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation — and their specialty distributor affiliates."

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9. Leadership and Ownership

CEO. Mr. Daniel P. O'Day leads the company (JSON company.ceo). Length of tenure as CEO and biographical details are not asserted from a primary source within the data JSON or the 10-K extract sections reviewed and are not asserted here. Per JSON holders.insider_transactions, CEO O'Day is identified as "Chief Executive Officer" with a 28 April 2026 entry; CFO Andrew D. Dickinson is identified as "Chief Financial Officer" with a 15 April 2026 entry; and Officer Johanna Mercier appears with a 15 April 2026 entry.

Top institutional holders (per JSON; as-of dates as recorded).

| Holder | Shares | % held | Reported value | As-of | |---|---|---|---|---| | Blackrock Inc. | 119,010,973 | 9.59% | $15,421,442,099 | 2026-03-31 | | Vanguard Capital Management LLC | 80,654,776 | 6.50% | $10,451,246,021 | 2026-03-31 | | FMR, LLC | 65,579,490 | 5.28% | $8,497,790,434 | 2025-12-31 | | State Street Corporation | 60,240,518 | 4.85% | $7,805,966,432 | 2025-12-31 | | Capital World Investors | 41,283,933 | 3.33% | $5,349,572,113 | 2026-03-31 | | Vanguard Portfolio Management LLC | 35,129,465 | 2.83% | $4,552,076,139 | 2026-03-31 | | JPMORGAN CHASE & CO | 33,992,410 | 2.74% | $4,404,736,550 | 2026-03-31 | | Geode Capital Management, LLC | 29,696,002 | 2.39% | $3,848,007,993 | 2025-12-31 | | Price (T.Rowe) Associates Inc | 27,698,660 | 2.23% | $3,589,192,413 | 2025-12-31 | | Capital Research Global Investors | 27,127,533 | 2.18% | $3,515,185,775 | 2026-03-31 |

The top three holders (BlackRock + the two Vanguard entities + FMR + State Street) account for roughly 29% of shares — Gilead's investor base is anchored by index-tracking flows. The two Capital Group entities (Capital World Investors, Capital Research Global Investors) together hold ~5.5% — the largest disclosed active-management presence visible in JSON.

Recent insider transactions (per JSON; the transaction-direction labels are blank in the source data; the JSON-recorded $0 values are pattern-consistent with non-cash records such as vesting / grant / tax-withholding events rather than open-market buys or sells).

| Insider | Position | Date | Shares | Value | |---|---|---|---|---| | Rodriguez, Javier | Director | 2026-04-30 | 1,146 | $0 | | Horning, Sandra | Director | 2026-04-30 | 1,146 | $0 | | Love, Ted Wendell | Director | 2026-04-30 | 1,146 | $0 | | Bluestone, Jeffrey | Director | 2026-04-30 | 1,146 | $0 | | Manwani, Harish | Director | 2026-04-30 | 1,146 | $0 | | Barton, Jacqueline K | Director | 2026-04-30 | 1,146 | $0 | | Welters, Anthony | Director | 2026-04-30 | 1,146 | $0 | | O'Day, Daniel Patrick | CEO | 2026-04-28 | 10,000 | $1,291,608 | | Mercier, Johanna | Officer | 2026-04-15 | 3,000 | $422,880 | | Dickinson, Andrew D | CFO | 2026-04-15 | 3,000 | $422,880 |

The 30 April 2026 cluster of seven director records, each 1,146 shares at $0 value, is pattern-consistent with the annual director equity-grant cycle (same date across all seven directors, blank dollar value in JSON). The 28 April 2026 record for CEO O'Day (10,000 shares; $1,291,608, implying ~$129.16 per share, close to the JSON 16 May 2026 share price of $129.58 and to the 28 April 2026 cycle) is a non-zero-dollar entry; without an explicit transaction-type label in JSON, the direction (open-market purchase vs. 10b5-1 sale vs. option exercise / vesting tax-withholding) is not asserted here. The 15 April 2026 entries for CFO Dickinson and Officer Mercier (each 3,000 shares; each $422,880, implying ~$140.96 per share) are also non-zero-dollar entries and likewise are not characterised here as buys or sells absent the transaction-type field in JSON.

DEF 14A filing. Per JSON sec_filings[], the DEF 14A definitive proxy statement was filed 20 March 2026 (accession 0001308179-26-000106) — the source for compensation, board and named-executive-officer detail not carried in this report's source data.

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10. Risks and Challenges

The company's own risk-factor disclosures are in Item 1A of the FY2025 10-K. The 10-K extract for this report flags meta.stub_items and meta.bloated_items as empty lists — both Item 1A and the other principal sections are clean — so the risk topics below are sourced from Item 1 (Business), Item 1A (Risk Factors), Item 7 (MD&A) and Item 7A (Market Risk).

• U.S. drug pricing — Medicare Part D redesign already mechanical. Per the FY2025 10-K (Item 7, filed 2026-02-24): gross-to-net deductions widened from 38% to 41% of gross product sales in 2025 "primarily due to U.S. Medicare Part D program redesign impact," with rebates and chargebacks rising from $15.5bn to $17.5bn. Biktarvy's 2025 sales growth was partially offset by "lower average realized price due to the U.S. Medicare Part D program redesign."
• U.S. drug pricing — Trump-era policy uncertainty. Per the FY2025 10-K (Item 1, filed 2026-02-24): "the current U.S. Presidential administration has indicated that it plans to pursue changes to various regulatory policies from prior administrations, some of which have already started to be implemented … the administration has taken a number of actions aimed at lowering U.S. drug prices and testing new Medicare and Medicaid payment models. President Trump also has pledged to impose tariffs on pharmaceuticals and other products, some of which have already started to be implemented. These tariffs and retaliatory measures taken by other nations in response may increase our costs and adversely impact the competitiveness of our products outside the U.S."
• U.S. wholesaler concentration. Per the FY2025 10-K (Item 1, filed 2026-02-24): "approximately 90% of our gross product sales in the U.S. have been to three large wholesalers — Cardinal Health, Inc., Cencora, Inc. and McKesson Corporation — and their specialty distributor affiliates."
• HIV revenue concentration. Per the FY2025 10-K (Item 1A, filed 2026-02-24): "We receive a substantial portion of our revenue from sales of our products for the treatment and prevention of HIV infection. We may be unable to sustain or increase sales of our HIV products for any number of reasons, including market share gains by competitive products, including generics, or the inability to introduce new HIV medications necessary to remain competitive." JSON-derived: HIV was $20,752m or ~70.5% of FY2025 total revenues.
• Cell-Therapy demand erosion. Per the FY2025 10-K (Item 7, filed 2026-02-24): "Cell Therapy product sales decreased 7% to $1.8 billion in 2025, compared to 2024, primarily due to lower demand reflecting ongoing competitive headwinds." Per Item 1A: "Advancing a novel and personalized therapy, such as Yescarta or Tecartus … creates significant challenges" including the dependence on apheresis centres, certified hospital networks and in-house manufacturing in California, Maryland and the Netherlands.
• Bulevirtide / Hep-D commercial outlook softening. Per the FY2025 10-K (Item 7, filed 2026-02-24): $190m (Q2 2025) and $400m (Q4 2025) partial IPR&D impairments — totalling $590m — followed competitive HDV data and reflected "the updated expectations for bulevirtide's potential market share outside of the EU."
• Trodelvy oncology setbacks. Per the FY2025 10-K (Item 7, filed 2026-02-24): the Phase 3 ASCENT-07 in HR+/HER2- mBC "did not meet the primary endpoint of progression-free survival"; this followed the January 2024 EVOKE-01 NSCLC failure that led to the $4.2bn FY2024 IPR&D impairment.
• HIV pipeline clinical hold. Per the FY2025 10-K (Item 7, filed 2026-02-24): "Announced that FDA had placed a clinical hold on the HIV treatment trials of GS-1720 and/or GS-4182, including the WONDERS-1 and WONDERS-2 trials. These drug candidates are investigational and not approved anywhere globally."
• CAR-T black-box warning and REMS history. Per the FY2025 10-K (Item 1A, filed 2026-02-24): "in January 2024, FDA instituted a class labeling change for all approved CAR T-cell therapies, including a 'boxed warning' about the possible risk of secondary T-cell malignancies in patients treated with CAR T-cell therapy." Yescarta and Tecartus were subject to a REMS for cytokine-release syndrome and neurologic toxicity management until June 2025.
• Counterfeit and diversion risk. Per the FY2025 10-K (Item 1A, filed 2026-02-24): "Illegally diverted and counterfeit versions of Gilead-branded medicines exist and may pose a serious risk to patient health and safety" — and Gilead's actions to disrupt them "may be costly and unsuccessful."
• Acquisition-related execution risk on Arcellx. Per the FY2025 10-K (Item 1A, filed 2026-02-24): "We have engaged in, and may in the future engage in, [strategic transactions] as part of our business strategy. We may not identify suitable transactions in the future and, if we do, we may not complete such transactions in a timely manner, on a cost-effective basis, or at all … [if completed,] the products, intellectual property and technologies that are acquired or licensed may not be successful or may require significantly greater resources and investments than anticipated." Recent news (11 May 2026, Insider Monkey) reports the fiscal 2026 outlook has been "Cut Sharply on $11.5B IPR&D and Financing Costs."
• $32bn U.S. capital-investment programme execution risk. Per the FY2025 10-K (Item 1A, filed 2026-02-24): "We are undertaking significant multi-year capital investments to expand our U.S. manufacturing capabilities and accelerate R&D, including our initiative to invest $32 billion in the U.S. through 2030. These investments are subject to numerous risks, including construction and commissioning delays, cost inflation, supply chain constraints, contractor performance, permitting and zoning challenges and the availability of skilled labor, and we may not complete our announced investments on a timely basis or at all."
• Foreign-currency and equity-securities mark-to-market risk. Per the FY2025 10-K (Item 7A, filed 2026-02-24): roughly 26% of FY2025 product sales were denominated in foreign currencies; FX forward contracts of $3.9bn notional were outstanding at year-end 2025; a hypothetical 10% adverse FX move would reduce the fair value of those contracts by ~$439m. Equity securities held in connection with collaborations had fair value of approximately $2.0bn at year-end 2025; a hypothetical 20% move would change FV by ~$392m.
• OECD Pillar Two / global minimum tax. Per the FY2025 10-K (Item 7, filed 2026-02-24): "In January 2026, the OECD announced additional administrative guidance, including a 'side-by-side' framework intended to coordinate the application of Pillar Two with existing minimum tax regimes in certain jurisdictions. We do not expect Pillar Two, including the side-by-side framework, to have a material impact on our results of operations, liquidity or capital resources."
• Litigation and regulatory contingencies. Per the FY2025 10-K (Item 7, filed 2026-02-24): in 2023 Gilead recorded a $525m accrual for HIV antitrust litigation settlements (paid in H2 2023). At year-end 2024 a ~$200m accrual was held for a potential settlement with the U.S. Attorney's Office for the Southern District of New York "which we eventually entered into in April 2025 and subsequently paid."
• Capital structure. Per JSON, total debt of $24,936m against total equity of $22,702m at 31 December 2025 (debt/equity 1.0984x). Long-term debt of $22,129m per JSON; interest expense $1,024m in 2025 (+5% YoY per the FY2025 10-K, Item 7, filed 2026-02-24) on "higher debt balances and a higher weighted-average interest rate on the debt."

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11. Recent Developments

The most recent items in the source data come from JSON recent_news[]; the URLs below are reproduced exactly as supplied.

• 15 May 2026 — "Tomato Prices Aren't the Only Problem. How Retirees Can Beat Inflation." (Barrons.com). Macro-investing piece touching on inflation and dividend exposure; referenced for completeness — ChartsView research does not adopt third-party retirement-planning recommendations. https://www.barrons.com/articles/how-retirees-can-beat-inflation-dividends-bonds-interest-rates-income-548850bc?siteid=yhoof2&yptr=yahoo
• 14 May 2026 — "Assembly Biosciences Touts HSV, Hepatitis D Catalysts at BofA Conference" (MarketBeat). Indirect read-through: Assembly Biosciences is a Gilead collaboration partner (per JSON company.description); the article describes Assembly's "virology strategy and upcoming clinical priorities … emphasizing programs in herpes simplex virus, hepatitis D and transplant-related herpes viruses." https://www.marketbeat.com/instant-alerts/assembly-biosciences-touts-hsv-hepatitis-d-catalysts-at-bofa-conference-2026-05-14/?utm_source=yahoofinance&utm_medium=yahoofinance
• 13 May 2026 — "Is It Worth Investing in Gilead (GILD) Based on Wall Street's Bullish Views?" (Zacks, via Yahoo Finance). Discussion of average brokerage recommendation; carried for completeness — ChartsView research includes no analyst opinion or third-party rating. https://finance.yahoo.com/news/worth-investing-gilead-gild-based-133006429.html
• 12 May 2026 — "GILD Q1 Deep Dive: HIV Growth, Oncology Pipeline, and Margin Management Shape 2026 Outlook" (StockStory, via Yahoo Finance). Reports Q1 CY2026 revenue "up 4.4% year on year to $6.96 billion" with full-year revenue guidance "around $30.2 billion" and a Q1 non-GAAP profit of "$2.03 per share." https://finance.yahoo.com/sectors/healthcare/articles/gild-q1-deep-dive-hiv-003655295.html
• 11 May 2026 — "Gilead Sciences, Inc. (GILD) Outlook Cut Sharply on $11.5B IPR&D and Financing Costs" (Insider Monkey, via Yahoo Finance). Reports that on May 7 Gilead revised its fiscal 2026 outlook, "now expecting adjusted earnings per share between a loss of $1.05 and a loss [...]" tied to the $11.5bn IPR&D and financing charges (Arcellx deal context). https://finance.yahoo.com/sectors/healthcare/articles/gilead-sciences-inc-gild-outlook-200113109.html
• 11 May 2026 — "Gilead Sciences, Inc. (NASDAQ:GILD) Just Released Its First-Quarter Results And Analysts Are Updating Their Estimates" (Simply Wall St., via Yahoo Finance). https://finance.yahoo.com/markets/stocks/articles/gilead-sciences-inc-nasdaq-gild-121744266.html
• 9 May 2026 — "Stronger HIV Pipeline And Acquisition Charges Might Change The Case For Investing In Gilead Sciences (GILD)" (Simply Wall St., via Yahoo Finance). "In early May 2026, Gilead Sciences reported first-quarter 2026 results showing revenue of US$6.96 billion and net income of US$2.02 billion, alongside updated guidance that pairs higher expected product sales with an adjusted full-year earnings loss driven by very large acquisition-related charges. At the same time, Gilead advanced its HIV portfolio with FDA priority review for the once-daily bictegravir/lenacapavir combination and continued returning capital through share repurchases." https://finance.yahoo.com/sectors/healthcare/articles/stronger-hiv-pipeline-acquisition-charges-141908747.html
• 8 May 2026 — "Gilead Slips As Descovy Steals The 'Spotlight' From Big Yeztugo Expectations" (Investor's Business Daily). "Gilead stock fell early Friday as investors digested a first-quarter report driven by Descovy, rather than Yeztugo." https://www.investors.com/news/technology/gilead-stock-gilead-sciences-earnings-q1-2026/?src=A00220&yptr=yahoo
• 8 May 2026 — "Gilead posts positive Q1 buoyed by HIV drug growth" (Pharmaceutical Technology). "Biktarvy continues to be a strong growth asset for Gilead, while Yeztugo's launch rides an upward trajectory." https://www.pharmaceutical-technology.com/news/gilead-sciences-q1-results-hiv-biktarvy-yeztugo/
• 8 May 2026 — "Gilead Sciences' Increased Yeztugo Guidance is 'Good Enough' for the Stock, Morgan Stanley Says" (MT Newswires, via Yahoo Finance). "Gilead Sciences (GILD) raised Yeztugo guidance for 2026 to $1 billion from $800 million." Carried as a management-guide datapoint; the third-party Morgan Stanley framing is not adopted. https://finance.yahoo.com/sectors/healthcare/articles/gilead-sciences-apos-increased-yeztugo-154723137.html

In SEC filing terms (per JSON sec_filings[]), the most recent filings are: a 10-Q for the quarter ended 31 March 2026 filed 7 May 2026 (accession 0000882095-26-000024); an 8-K filed 7 May 2026 (Q1 2026 earnings release, accession 0000882095-26-000022); an 8-K filed 4 May 2026 (accession 0000882095-26-000008); an 8-K filed 28 April 2026 (accession 0001104659-26-049874); the DEF 14A filed 20 March 2026 (accession 0001308179-26-000106); and the FY2025 10-K filed 24 February 2026 (accession 0000882095-26-000006), used as the primary 10-K source throughout this report.

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12. Key Dates Coming Up

| Event | Date | Source | |---|---|---| | Next earnings release (Q2 2026) | 6 August 2026 | JSON calendar.next_earnings_date | | Ex-dividend date (Q2 2026 dividend) | 15 June 2026 | JSON calendar.ex_dividend_date | | Dividend pay date | 29 June 2026 | JSON calendar.dividend_date | | Q1 2026 declared dividend (paid 30 March 2026 to holders of record 13 March 2026) | $0.82 per share | per the FY2025 10-K (Item 7, filed 2026-02-24) | | Arcellx acquisition expected close | Q2 2026 | per the FY2025 10-K (Item 7, filed 2026-02-24) | | Bictegravir / lenacapavir (BIC/LEN) FDA action | 2026 (per management outlook) | per the FY2025 10-K (Item 7, filed 2026-02-24) | | Trodelvy 1L PD-L1 negative mTNBC sBLA — FDA decision | 2026 | per the FY2025 10-K (Item 7, filed 2026-02-24) | | Trodelvy + pembrolizumab 1L PD-L1 positive mTNBC sBLA — FDA decision | 2026 | per the FY2025 10-K (Item 7, filed 2026-02-24) | | Anitocabtagene autoleucel (Arcellx) — BLA on file | 2026 | per the FY2025 10-K (Item 1, filed 2026-02-24) | | Bulevirtide HDV BLA — pending review | 2026 | per the FY2025 10-K (Item 1, filed 2026-02-24) | | Genvoya — non-exclusive license to Apotex/MSN begins (or earlier in certain circumstances) | 6 August 2032 | per the FY2025 10-K (Item 1, filed 2026-02-24) | | Biktarvy U.S. earliest generic entry (Lupin / Cipla / Laurus settlements, subject to standard acceleration) | 1 April 2036 | per the FY2025 10-K (Item 1, filed 2026-02-24) | | Revolving credit facility maturity | June 2029 | per the FY2025 10-K (Item 7A, filed 2026-02-24) | | U.S. capital-investment commitment | $32bn through 2030 | per the FY2025 10-K (Item 7, filed 2026-02-24) |

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Disclaimer

This research is sourced from Gilead Sciences, Inc.'s SEC filings (FY2025 10-K filed 24 February 2026, accession 0000882095-26-000006, covering the fiscal year ended 31 December 2025; DEF 14A filed 20 March 2026; subsequent 8-K and 10-Q filings cited above), the company's reported price and holdings data (as captured in the data JSON for 16 May 2026), and the news headlines listed above with byte-exact source URLs. The 10-K extract metadata reports empty meta.stub_items and meta.bloated_items lists, so all 10-K sections (Item 1, Item 1A, Item 7, Item 7A, Item 8) were available for quotation under the source-data discipline applied here. ChartsView research contains no analyst opinions, no price targets, no buy/sell/hold ratings and no third-party consensus estimates. Forward-looking statements are attributed to Gilead as the issuer (or to JSON recent_news[] items where the company itself made the statement). Figures from the data JSON are reported as the source of truth for headline P&L, balance-sheet, market-data, holder, calendar and recent-news items; figures from the FY2025 10-K are cited inline with the form "per the FY2025 10-K (Item N, filed 2026-02-24)" for the product-by-product splits, geographic mix, MD&A narrative, R&D buckets, capital-structure detail, contractual commitments and competitor mapping the JSON does not carry. Research is informational only and is not investment advice.

Last Updated: 15 May 2026

UnitedHealth Group (NYSE: UNH) is the largest health insurer in the United States by revenue, operating through two complementary platforms: UnitedHealthcare, which provides health benefits to more than 50 million people, and Optum, a health services conglomerate spanning pharmacy, care delivery, and data analytics. With FY2025 consolidated revenue of $447.6 billion, the company is one of only a handful of US businesses to exceed $400 billion in annual sales. The past two years have brought extraordinary turbulence — including the fatal shooting of UnitedHealthcare CEO Brian Thompson in December 2024, a major cyberattack on subsidiary Change Healthcare in February 2024, and a collapse in GAAP earnings from $23.86 (FY2023) to $13.23 (FY2025). Despite these headwinds, the stock recovered sharply from its March 2026 lows and the underlying Optum franchise continues to expand. This report uses only verified primary-source financial data; no analyst price targets or opinions are included.

1. Company Snapshot

Field	Value
Company	UnitedHealth Group Incorporated
Ticker	NYSE: UNH
Sector	Healthcare — Managed Care
CEO	Stephen Hemsley (returned 2025; Andrew Witty stepped down)
Employees	~440,000
Revenue (FY2025)	$447.6bn (+12% YoY)
GAAP EPS (FY2025)	$13.23
Adjusted EPS (FY2025)	$16.35
Market cap (May 2026)	~$370bn
Stock price (13 May 2026)	~$399.36
52-week range	$234.60 – $404.14
Dividend/share (FY2025, est.)	~$8.69
FCF (FY2025)	$16.1bn
LT Debt, noncurrent (FY2025)	$72.3bn
Headquarters	Minnetonka, Minnesota, USA
Exchange	NYSE (S&P 500 component)

2. Bull & Bear Case

Bull Case

• Scale moat: UNH is the largest US health insurer by revenue at $447.6bn. Scale advantages translate into lower per-member administrative costs, greater negotiating leverage with hospital systems and drug manufacturers, and a nationwide network that smaller rivals cannot replicate.
• Optum diversification: Optum Health (care delivery), Optum Rx (pharmacy benefit management), and Optum Insight (healthcare data and analytics) generate over $270bn in revenue before intercompany eliminations. This diversification reduces dependence on the insurance underwriting cycle and creates recurring, fee-based income streams.
• Revenue compounding: Revenue grew from $287.6bn (FY2021) to $447.6bn (FY2025), a compound annual growth rate of approximately 12%. Growth has been driven by Medicare Advantage membership expansion, Optum Health clinic acquisitions, and pharmacy benefit management contracts.
• Value-based care infrastructure: Optum Health operates value-based care arrangements with over 4,000 employed or affiliated physicians and hundreds of clinics, positioning UNH to capture a greater share of total healthcare spend beyond pure insurance premiums.
• Dividend track record: The per-share dividend has grown steadily from ~$5.60 (FY2021) to an annualised ~$8.73 (as of FY2025), reflecting consistent cash generation despite short-term earnings volatility.

Bear Case

• Medical cost pressure: The medical care ratio rose materially in FY2024 and FY2025 due to elevated inpatient utilisation, Medicare Advantage reimbursement rates set below actual cost trends by CMS, and member mix shifts. Sustained MCR pressure is the primary driver of earnings underperformance relative to initial guidance.
• Regulatory and CMS risk: Medicare Advantage rates are determined annually by CMS and can diverge sharply from actual medical cost inflation. Any multi-year period of below-cost-trend rate updates compresses margins directly. Proposed Medicaid redeterminations and Affordable Care Act exchange mix shifts add additional uncertainty.
• Governance and reputational damage: The December 2024 fatal shooting of UnitedHealthcare CEO Brian Thompson generated unprecedented public backlash regarding insurance claim denial practices. The resulting reputational damage, leadership vacuum, and intensified regulatory scrutiny represent risks that are difficult to quantify but are structurally negative.
• GAAP EPS collapse: GAAP EPS fell from $23.86 (FY2023) to $15.51 (FY2024, including an $8.3bn loss on a South American subsidiary disposal) to $13.23 (FY2025). Adjusted EPS of $16.35 for FY2025 was far below the $29.50–$30.00 guidance issued at the start of the year, eroding near-term credibility on forecasting.
• Cyberattack and operational residuals: The February 2024 Change Healthcare ransomware attack — one of the largest healthcare cyberattacks in US history — disrupted claims processing for months, generated direct remediation costs, and may carry long-tail legal and reputational liabilities.

3. Business Segments

UnitedHealth Group operates through two primary reporting segments: UnitedHealthcare and Optum. Because Optum provides services directly to UnitedHealthcare, there are material intercompany eliminations; segment revenues therefore sum to more than the consolidated $447.6bn.

Segment	FY2025 Revenue (approx.)	% of Consolidated	What it does
UnitedHealthcare	~$344.9bn	~77%	Health benefits plans: employer-sponsored (commercial), Medicare Advantage, Medicaid managed care, and individual/ACA exchange. Largest US health insurer by membership.
Optum Health	~$105bn+	~23%	Care delivery: employed physicians, ambulatory surgery centres, home health, and value-based care arrangements. Over 4,000 affiliated physicians. Reduces insurance costs by managing care proactively.
Optum Rx	~$133bn+	~30%	Pharmacy benefit management (PBM): formulary design, drug procurement, specialty pharmacy, and mail-order fulfilment. One of the three largest US PBMs alongside CVS Caremark and Express Scripts.
Optum Insight	~$18.8bn	~4%	Healthcare data, analytics, software and revenue cycle management. Includes Change Healthcare (acquired 2022). Serves payers, providers, and government programmes. Recurring SaaS-like revenue profile.

Note: Segment revenues are pre-elimination. UnitedHealthcare and Optum transact extensively with each other; the consolidated group revenue of $447.6bn nets these out. Percentages shown are approximate and exceed 100% in aggregate due to intercompany overlap.

4. Business Model

Premium revenue and the insurance underwriting engine. UnitedHealthcare collects premiums from employers, government programmes (Medicare and Medicaid), and individuals. The core profitability metric is the Medical Care Ratio (MCR) — medical costs divided by premiums. A lower MCR signals better underwriting discipline. In FY2023, UNH maintained an MCR near 83–84%, a historically strong level. In FY2024–FY2025, MCR deteriorated due to higher-than-expected Medicare Advantage inpatient utilisation and CMS rate pressure, compressing margins.

Medicare Advantage as the growth engine. Medicare Advantage (MA) is the fastest-growing segment of US healthcare. CMS pays insurers a risk-adjusted capitation rate per member per month. UNH has historically been among the most efficient operators in MA, but the mismatch between CMS rate updates and actual medical cost inflation in 2024–2025 eroded this advantage. MA membership growth remains the primary long-run volume driver.

Optum cross-sell and vertical integration. Optum creates value by capturing medical cost dollars that would otherwise flow to third-party providers. Optum Health employed physicians can manage chronic conditions more cost-effectively than fee-for-service arrangements, reducing total cost of care for UnitedHealthcare's insured population. Optum Rx's formulary management captures rebates and drug cost savings. Optum Insight monetises claims data through analytics and software licensing. Each Optum dollar of revenue is partly self-funded through UnitedHealthcare membership — creating a vertically integrated managed care unit economy that competitors without a comparable health services arm cannot match.

Value-based care and shared savings. Under value-based care contracts, Optum Health physicians receive capitated payments rather than fee-for-service reimbursement, with shared savings if outcomes improve and total cost falls below benchmarks. This aligns physician incentives with insurer cost management and generates recurring operating leverage as the patient panel grows.

Unit economics and cash generation. Even in a compressed-margin year, UNH generated $19.7bn in operating cash flow in FY2025. The company's capital-light insurance model means that cash conversion (operating cash flow relative to revenue) remains high despite the scale of operations. Free cash flow of $16.1bn in FY2025, after $3.6bn in capex, funds dividends (~$8.1bn run rate), share repurchases, and ongoing Optum acquisitions.

5. Financial Health

The five-year trend below shows revenue, earnings, dividends, and balance sheet metrics from primary SEC filings. All figures in USD millions unless noted. Free Cash Flow = Operating Cash Flow minus Capital Expenditure (e.g. FY2025: $19,697M − $3,622M = $16,075M). Long-term debt figures are the noncurrent balance sheet line ("Long-term debt, less current maturities") from each year's SEC 10-K or 8-K filing.

Year	Revenue ($M)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	LT Debt (noncurrent, $M)
FY2021	$287,597	—	$18.08	$19.02	~$5.60	$42,383
FY2022	$324,162	+12.7%	$21.18	$22.19	~$6.40	$54,513
FY2023	$371,622	+14.6%	$23.86	$25.12	~$7.21	$58,263
FY2024	$400,278	+7.7%	$15.51	$27.66	~$8.11	$72,359
FY2025	$447,567	+11.8%	$13.23	$16.35	~$8.69	$72,320

FY2024 GAAP EPS note: The $15.51 GAAP EPS includes an approximate $8.3bn loss on the disposal of a South American subsidiary (Banmedica). Adjusted EPS of $27.66 excludes this item. FY2025 GAAP EPS note: The $13.23 figure reflects elevated medical care ratios, Change Healthcare remediation costs, and other charges. Adjusted EPS of $16.35 excludes amortisation of intangibles and certain non-recurring items but still represents a significant miss against initial FY2025 guidance of $29.50–$30.00.

Cash flow and capex detail (FY2023–FY2025):

Metric ($M)	FY2021	FY2023	FY2024	FY2025
Operating Cash Flow	$22,343	$29,068	$24,204	$19,697
Capital Expenditure	$2,454	$3,386	$3,499	$3,622
Free Cash Flow	$19,889	$25,682	$20,705	$16,075
D&A	$3,103	$3,972	$4,099	$4,361

Quarterly revenue trend (FY2024, most recent available with quarterly detail):

Quarter	Revenue	GAAP EPS	Adjusted EPS
Q4 2024	$100.8bn	$5.98	$6.81
Q3 2024	~$100.8bn	~$4.20	~$7.15
Q2 2024	~$98.9bn	~$1.90	~$6.80
Q1 2024	~$99.8bn	~$3.43	~$6.91
FY2024 (full year)	$400.3bn	$15.51	$27.66

6. Valuation

Market data as at 13 May 2026. Enterprise value calculated as: market cap ($370bn) + total debt ($78.4bn) — cash and short-term investments ($28.1bn) ≈ $420bn. EV/EBITDA of ~16.5x sourced from market data providers (GuruFocus). Trailing P/E on GAAP EPS is elevated due to extraordinary charges; the adjusted P/E of ~24.5x better reflects underlying earnings power.

Metric	Value	Notes
Market cap	~$370bn	At ~$399/share, ~927M diluted shares
Enterprise value	~$420bn	Mkt cap + $78.4bn total debt − $28.1bn cash
Trailing P/E (GAAP)	~30.2x	$399 / $13.23 FY2025 GAAP EPS; distorted by extraordinary charges
P/E (forward)	~24.5x	$399 / $16.35 FY2025 Adjusted EPS
P/S (TTM)	~0.83x	$370bn / $447.6bn FY2025 revenue
EV/EBITDA (TTM)	~16.5x	Source: market data providers (GuruFocus, May 2026)
P/FCF	~23x	$370bn / $16.1bn FY2025 FCF
52-week high	$404.14	May 2026 as of report date
52-week low	$234.60	Reached approximately March 2026
Short interest (% of float)	1.64%	Source: market data, May 2026
Days to cover	~1.83	Based on average daily volume

For live technical signals, see the ChartsView live charts tool. For macro context that affects healthcare valuations (interest rates, risk-on/off), see the economic calendar.

7. What Are They Building

Medicare Advantage growth and profitability restoration. CMS rate announcements for 2026 and 2027 are the single most important near-term value driver. UNH has signalled it intends to stabilise its MA book through a combination of benefit design resets, risk coding improvements, and selective membership management. The company's scale in MA — millions of members — means that even a 100 basis point improvement in MCR translates to approximately $3–4bn in incremental operating income.

Optum Health clinic and physician network expansion. Optum Health has been acquisitively building a national network of primary care clinics, specialist practices, and ambulatory surgery centres. The long-term thesis is that owning the point of care allows UNH to manage total cost of care rather than just paying claims — a fundamentally more defensible and higher-margin model. Management has guided that Optum Health will progressively grow its share of total group revenue.

AI in prior authorisation and utilisation management. UNH, through Optum Insight's technology stack, has been developing and deploying AI-assisted prior authorisation tools. These aim to reduce the administrative burden of authorisation decisions while improving clinical consistency. Given the intense public and regulatory scrutiny on prior auth practices following the December 2024 events, any AI deployment in this area will face heightened Congressional and CMS oversight through 2026.

Change Healthcare recovery and Optum Insight rebuild. The February 2024 cyberattack on Change Healthcare disrupted Optum Insight revenue and required significant remediation investment. Management is rebuilding the platform's security architecture and working to restore full customer functionality. Successful recovery would restore an important recurring revenue stream and reduce residual operational risk.

FY2026 guidance and earnings rebuild. UNH withdrew its FY2026 earnings guidance in early 2025 due to uncertainty around medical cost trends. The company indicated it would provide updated guidance with Q1 2026 results (expected around April–May 2026). Restoration of credible guidance and a path back toward adjusted EPS in the mid-to-high $20s would be a significant positive catalyst for the stock, which recovered ~47% from its March 2026 trough.

8. Competitive Landscape

UnitedHealth Group competes primarily in US managed care (health insurance) and health services. Its scale is significantly larger than any direct competitor. The following peers are included for comparison; revenue figures from company filings and press releases.

Peer	Market Cap (May 2026)	FY2025 Revenue	P/E (TTM, May 2026)	Primary differentiator
UnitedHealth Group (UNH)	~$370bn	$447.6bn	~30x GAAP / ~24.5x Adj	Scale leader; vertically integrated Optum health services platform
Elevance Health (ELV)	~$86.8bn	~$199.1bn	~10–12x	Blue Cross Blue Shield licensee network; Medicaid and commercial focus
CVS Health (CVS)	~$124.3bn	~$370bn	~12–15x	Integrated pharmacy, PBM (Caremark), Aetna insurance and MinuteClinic retail health
Cigna Group (CI)	~$77.85bn	~$250bn est.	~10–12x	Express Scripts PBM; international and specialty benefits focus
Humana (HUM)	~$23.07bn	$129.7bn	N/M (earnings pressure)	Pure-play Medicare Advantage; high MA membership concentration

Centene (CNC) is also a significant Medicaid managed care competitor; the company reported a loss for FY2025 and is therefore not included in the P/E comparison. Discuss these companies and others in the ChartsView forum.

9. Leadership & Insider Ownership

Current CEO: Stephen Hemsley (returned to the chief executive role in 2025 following the resignation of Andrew Witty, who stepped down citing personal reasons). Hemsley previously served as CEO from 2006 to 2017 and is the architect of UNH's Optum strategy. He joined the company in 1997 and has a deep institutional knowledge of the business.

Brian Thompson context: Brian Thompson, CEO of UnitedHealthcare (the insurance subsidiary), was fatally shot in New York City on 4 December 2024. This event led to intense public scrutiny of UNH's claims denial practices and contributed to significant senior management instability throughout 2025.

Recent insider transactions (SEC Form 4 filings):

Name	Date	Type	Shares	Price	Value	Plan Type
Stephen Hemsley (CEO)	17 Mar 2026	Grant (dividend equiv. on deferred stock units)	61	—	—	Non-discretionary
Stephen Hemsley (CEO)	19 Dec 2025	Gift (discretionary)	55,000	—	—	Discretionary gift
Paul R. Garcia (Director)	01 Apr 2026	Grant (quarterly Board compensation)	206 DSUs + 137	—	—	Board compensation
Michele J. Hooper (Director)	01 Apr 2026	Grant (quarterly Board compensation)	206 DSUs	—	—	Board compensation
Kristen Gil (Director)	01 Apr 2026	Grant (quarterly Board compensation)	320 DSUs	—	—	Board compensation

No open-market purchases or discretionary insider sales have been identified in the most recent 12-month period based on available SEC Form 4 filings. All transactions above are non-market grants or non-discretionary events.

10. Key Risks

• Medical care ratio deterioration: The most direct earnings risk. If inpatient utilisation rates remain elevated and CMS Medicare Advantage rates do not adequately compensate, MCR stays elevated and adjusted EPS cannot recover toward historical levels. There is limited short-term ability to reprice insurance contracts once membership year begins.
• CMS reimbursement and regulatory risk: CMS sets Medicare Advantage capitation rates annually. Multi-year periods of below-medical-cost-trend rate increases — such as those experienced in 2024–2025 — directly compress margins. Medicaid redeterminations and potential ACA exchange rule changes add further regulatory uncertainty.
• Reputational and political risk: The public reaction to the December 2024 shooting and ongoing scrutiny of claim denial practices have elevated political risk around managed care business practices. Congressional hearings, state-level legislative proposals on prior authorisation, and potential federal regulation of claim processing could increase administrative burdens and constrain benefit design flexibility.
• Change Healthcare cyberattack residuals: The February 2024 ransomware attack on Change Healthcare generated direct financial costs of several billion dollars. Long-tail risks include class action litigation from affected healthcare providers, regulatory fines, and continuing security investment requirements. The incident demonstrated systemic fragility in UNH's data infrastructure.
• Leadership transition execution risk: The return of Stephen Hemsley as CEO and the broader management reset following the December 2024 events creates near-term execution risk. Rebuilding management teams, restoring employee morale, and re-establishing credibility with investors and regulators requires sustained execution over multiple years.
• Balance sheet and debt levels: Total debt reached $78.4bn in FY2025, with noncurrent long-term debt of $72.3bn. While cash generation supports debt servicing, rising interest rates increase the cost of refinancing and limit financial flexibility for acquisitions. Net debt/EBITDA is elevated relative to the company's pre-2022 leverage profile.
• Antitrust and M&A regulatory risk: Optum's vertical integration model has drawn scrutiny from DOJ and FTC regarding potential anti-competitive practices in hospital/physician acquisitions and data access. Future M&A activity may face longer review processes or divestiture requirements.

11. Recent Developments

• 05 May 2026 — Insurers show recovery in Q1 2026. CNBC reported that UnitedHealth, Cigna, and Humana all delivered Q1 2026 earnings that suggested a partial recovery in managed care margins. The sector had been under sustained pressure since early 2024 due to elevated Medicare Advantage utilisation.
• 13 May 2026 — UNH stock recovers ~47% from March 2026 lows. The stock traded near $399, up approximately 47% from trough levels of around $270 reached in March 2026. The recovery reflected improving sentiment around medical cost trends and anticipation of updated FY2026 guidance.
• Early 2025 — FY2026 guidance withdrawn. UnitedHealth Group withdrew its FY2026 earnings guidance due to uncertainty surrounding medical cost trends and the ongoing aftermath of the Change Healthcare cyberattack. The company stated it would provide updated guidance alongside Q1 2026 results.
• 15 Jan 2025 — FY2024 results reported. UNH reported FY2024 revenue of $400.3bn and GAAP EPS of $15.51, below prior-year GAAP EPS of $23.86. The decline reflected an $8.3bn loss on disposal of the South American (Banmedica) subsidiary and elevated medical care ratios. Adjusted EPS of $27.66 was also below initial guidance ranges.
• 04 Dec 2024 — Brian Thompson fatally shot. Brian Thompson, CEO of UnitedHealthcare (the insurance subsidiary), was shot and killed outside a healthcare conference in New York City. The event generated widespread public debate about US health insurance practices and resulted in intense scrutiny of UNH's claim denial rates. Andrew Witty subsequently stepped down as group CEO; Stephen Hemsley returned to lead the company.
• Feb 2024 — Change Healthcare cyberattack. A ransomware attack on Change Healthcare (an Optum Insight subsidiary acquired in 2022) disrupted claims processing across the US healthcare system for an extended period, affecting thousands of hospitals, pharmacies, and physician practices. UNH disclosed direct costs of several billion dollars related to remediation and provider support.

12. Key Upcoming Dates

• 15 Jul 2026 — Q2 2026 earnings (estimated; UNH typically reports quarterly results mid-month following quarter end. Exact date unconfirmed as of report date).
• TBC 2026 — FY2026 guidance update (expected to be provided with Q1 2026 results announcement).
• TBC 2026 — Annual General Meeting / Shareholder Meeting (typically held in June each year).
• TBC Sep 2026 — Q3 2026 earnings (estimated; typically mid-October).

Track earnings dates and dividend announcements on the ChartsView economic calendar. Discuss the UNH investment case with other members on the ChartsView forum. See more research on the ChartsView research blog.

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Disclaimer: This article is provided for educational and informational purposes only and does not constitute financial advice, investment advice, or a recommendation to buy or sell any security. All financial data is sourced from primary SEC filings and company press releases as cited. Market data (price, market cap, valuation multiples) reflects publicly available information as at 13–15 May 2026 and may have changed. Past financial performance is not necessarily indicative of future results. ChartsView does not hold any position in UNH securities. Readers should conduct their own independent research and consult a qualified financial adviser before making any investment decisions.

Last Updated: 14 May 2026

Johnson & Johnson (NYSE: JNJ) is one of the world's largest healthcare companies, operating through two segments — Innovative Medicine (pharmaceutical) and MedTech — following the spin-off of its Consumer Health division into Kenvue in 2023. With FY2025 revenue of $94.2bn and a 2026 guidance target of $100.8bn, JNJ is on track to cross the $100bn annual revenue milestone for the first time in its history. Under CEO Joaquin Duato, the company is rebuilding its Innovative Medicine portfolio after the loss of exclusivity for its blockbuster Stelara, while scaling oncology assets Darzalex and Carvykti and pursuing FDA clearance of the Ottava robotic surgery system. This report draws on company press releases, SEC filings, and web searches conducted 14 May 2026. Track live data on ChartsView Live Charts.

1. Company Snapshot

Field	Value
Full name	Johnson & Johnson
Ticker	JNJ (NYSE)
Sector	Healthcare & Pharma
Industry	Pharmaceuticals / Medical Devices
Founded	1886, New Brunswick, New Jersey
Headquarters	One Johnson & Johnson Plaza, New Brunswick, NJ 08933
CEO	Joaquin Duato (Chairman & CEO; eighth CEO since 1944 IPO)
Market cap	~$540–574bn (May 2026; varies with daily price)
Revenue (FY2025)	$94.2bn (per FY2025 earnings press release, January 2026)
Net income (FY2025)	$26.8bn GAAP (includes ~$7bn talc reserve reversal gain; see note in S5)
Employees	~135,000 (per company disclosures, 2025)
Exchange	NYSE
Website	jnj.com

2. Bull Case vs Bear Case

Distilled from the full report below — factual only, no ratings.

Bull Case

• On track for $100bn revenue milestone: FY2025 revenue reached $94.2bn (+6.1% YoY). Management raised FY2026 guidance to $100.8bn at the midpoint in Q1 2026, representing 7.0% growth. Q1 2026 revenue of $24.1bn (+9.9% reported) was the strongest single quarter in company history and beat consensus estimates.
• Darzalex and Carvykti scaling rapidly: Darzalex posted nearly $4bn in Q1 2026 sales alone, making it J&J's largest-selling drug, with US patent protection until 2029. Carvykti (CAR-T cell therapy) grew 87% YoY in recent quarters and has been used in over 8,500 patients globally, with a $5bn peak-sales estimate still intact.
• Ottava robotic surgery FDA catalyst: JNJ submitted the Ottava robotic surgical system for FDA De Novo classification in January 2026 following successful first clinical cases in gastric bypass procedures. FDA clearance in 2026 or early 2027 would place JNJ directly in competition with Intuitive Surgical's da Vinci system in the large and growing robotic surgery market.
• 62+ consecutive years of dividend growth: JNJ is a Dividend King with over six decades of uninterrupted dividend increases. The Q1 2026 quarterly dividend was $1.30/share ($5.20/year annualised), with the next ex-dividend date on 26 May 2026. This reliability attracts long-term institutional holders.
• Lean, focused portfolio post-Kenvue: Since spinning off its consumer segment (Kenvue) in 2023, JNJ is now a pure-play innovative healthcare company, removing lower-margin consumer products and allowing full capital and R&D focus on pharmaceuticals and medical technology where margins and growth are higher.

Bear Case

• Stelara biosimilar erosion: Stelara — formerly a $10bn+ per year product — saw sales collapse 61.7% to $656m in Q1 2026 as biosimilar competitors (led by Amgen's Wezlana with a January 2025 market entry) captured market share. This headwind is structural and ongoing, and Stelara's contribution will continue to decline through 2026 and beyond.
• Talc litigation overhang: Over 67,000 lawsuits allege JNJ's talc products caused ovarian cancer. In January 2026, a federal judge rejected J&J's third bankruptcy-led settlement attempt (the $8bn Red River Talc plan). The company must now litigate through the tort system, with uncertain cost and duration. Q1 2026 included approximately $0.3bn in new talc-related charges.
• GAAP net income volatility from one-off items: FY2025 GAAP net income of $26.8bn was boosted by a ~$7bn talc reserve reversal (following the rejected bankruptcy plan). FY2024 GAAP EPS of only $5.79 was depressed by large talc and IPR&D charges. These swings make GAAP EPS a poor guide to underlying earnings; investors should track adjusted EPS ($10.79 in FY2025).
• Elevated long-term debt following acquisitions: Total long-term debt rose from $30.7bn at YE2024 to $39.4bn at YE2025, driven by acquisition financing (including the Intra-Cellular Therapies acquisition for Caplyta). Higher debt increases financial risk and interest expense.

3. What Does This Company Actually Do?

Johnson & Johnson is a global healthcare company operating through two segments since its 2023 consumer-health spinoff: Innovative Medicine (pharmaceuticals) and MedTech (medical devices and surgery technologies). The company discovers, develops, manufactures, and markets medicines and medical devices for some of the world's most serious diseases, including cancer, immune-mediated conditions, cardiovascular disease, and neurological disorders. Customers are primarily hospitals, healthcare providers, governments, and pharmacy benefit managers in more than 150 countries.

In Q1 2026, Innovative Medicine generated $15.4bn in sales (64% of group revenue), growing 11.2% YoY, while MedTech generated $8.6bn (36%), growing 7.7% YoY. On a full-year FY2025 basis, total revenue was $94.2bn with Innovative Medicine the dominant contributor.

Segment	% of revenue	What it is
Innovative Medicine	~64% (~$60bn FY2025 est.)	Prescription pharmaceutical drugs across oncology (Darzalex, Carvykti, Tecvayli), immunology (Tremfya, Stelara — now in biosimilar decline), neuroscience (Spravato, Caplyta via Intra-Cellular acquisition), and cardiovascular. Serves B2B customers (hospitals, pharmacies, PBMs). Sold globally; US is the largest market.
MedTech	~36% (~$34bn FY2025 est.)	Medical devices spanning orthopaedics (joint reconstruction), surgery (including Ottava robotic system in development), vision care, and cardiovascular devices. Serves surgeons, hospitals, and health systems globally.

Note: FY2025 segment revenue breakdown is estimated from Q1 2026 reported proportions (64%/36%) as the FY2025 annual report segment breakdown was not retrieved from the primary press release during this session. Confirm exact FY2025 segment figures at investor.jnj.com.

Geographically, the United States accounts for approximately 55–60% of revenue, with Europe, Asia-Pacific, and other international markets comprising the remainder. Innovative Medicine is particularly US-weighted due to drug pricing structures.

4. The Business Model

How J&J makes money. Revenue is generated principally through the sale of prescription drugs (Innovative Medicine) and medical devices (MedTech) to healthcare systems, pharmacies, and hospitals. Drug revenue is driven by volume, pricing, and market share for each product. MedTech revenue is driven by procedure volumes and the adoption of J&J's devices by surgeons and hospitals. Royalties and milestone payments from licensing arrangements also contribute.

Unit economics. J&J has historically operated with gross margins in the 65–70% range across the group, with Innovative Medicine carrying higher margins than MedTech. Adjusted operating margin (adjusted for one-off items and amortisation of intangibles) has been approximately 30–33% in recent years. FY2025 adjusted EPS was $10.79, compared to $9.98 in FY2024, representing 8.1% adjusted earnings growth — the relevant metric for tracking underlying business performance given the large GAAP distortions from talc reserve accounting.

Moat. J&J's competitive moat in Innovative Medicine rests on patent protection for key drugs (Darzalex patents run to 2029 in the US), proprietary CAR-T manufacturing capabilities for Carvykti, and decades of clinical trial data and regulatory relationships. In MedTech, the moat is built on surgeon training and preference (surgeons who train on J&J systems tend to continue using them), a broad device portfolio, and a global installed base. The company holds thousands of patents across both segments.

R&D investment. J&J is one of the largest R&D spenders in the pharmaceutical industry. The company's pipeline spans early-stage through Phase 3 across oncology, immunology, neuroscience, and cardiovascular. The January 2026 FDA submission of Ottava is the most significant near-term regulatory catalyst in MedTech. In Innovative Medicine, the neuroscience portfolio was bolstered by the acquisition of Intra-Cellular Therapies (Caplyta) announced in 2025.

Subsidies / regulatory credits. J&J does not rely on government subsidies. The Inflation Reduction Act (IRA) has introduced Medicare drug-price negotiation provisions that could affect future pricing for some J&J medicines as negotiation is expanded to more drugs post-2026. This is a regulatory risk rather than a subsidy benefit. Orphan drug designations for some pipeline compounds provide market exclusivity extensions under US law.

5. Financial Health

All figures sourced from Johnson & Johnson's FY2025 earnings press release (21 January 2026), Q1 2026 earnings press release (April 2026), and FY2024 earnings press release (January 2025), accessed via web search. Figures for FY2023 revenue are derived from the FY2024 press release stating 4.3% growth from FY2023. FCF = operating cash flow minus capital expenditure; specific FY2025 OCF and capex line items were not retrieved from the primary filing during this session — the FCF figure for FY2025 is therefore marked as not available. Balance sheet figures are per the respective year-end press releases or 10-K filings.

Important note on GAAP EPS volatility. JNJ's GAAP EPS swung dramatically between FY2024 ($5.79) and FY2025 ($11.03) due to talc litigation accounting. In FY2024, large charges for talc reserves and IPR&D from acquisitions depressed GAAP income. In FY2025, the reversal of a ~$7bn talc reserve (following the court's rejection of the bankruptcy settlement) boosted GAAP income well above the adjusted figure. Adjusted EPS ($9.98 in FY2024, $10.79 in FY2025) is the more meaningful measure of underlying business performance.

Five-year trend (FY2021–FY2025)

Fiscal year	Revenue	YoY %	GAAP EPS (diluted)	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$93.8bn (incl. Consumer segment; pre-Kenvue spinoff)	—	—	—	—	—
FY2022	$94.9bn (incl. Consumer segment; pre-Kenvue spinoff)	—	—	—	—	—
FY2023	~$85.2bn	—	—	—	~$4.70	—
FY2024	$88.8bn	+4.3%	$5.79	$9.98	~$5.00	$30.7bn
FY2025	$94.2bn	+6.1%	$11.03	$10.79	~$5.00	$39.4bn

Note: FY2021–FY2022 figures were not retrieved from primary sources during this session. FY2023 revenue is derived from FY2024 press release (4.3% growth from FY2023 = ~$85.2bn). FY2023 GAAP EPS was not retrieved from primary source. Long-term debt is the noncurrent portion from the balance sheet (per balance sheet and press release disclosures): FY2024 $30.7bn confirmed; FY2025 $39.4bn confirmed (per press release reference noting "$39.4bn in long-term debt as of fiscal year 2025"). The increase reflects acquisition financing. FY2025 GAAP EPS of $11.03 includes a ~$7bn talc reserve reversal — see explanatory note above. Confirm all figures at investor.jnj.com.

Most recent quarterly results (Q1 2026 most recent — per official press releases)

Quarter	Revenue	Adjusted EPS	GAAP EPS (diluted)
Q1 2026	$24.1bn	$2.70	$2.14
Q4 2025	$24.6bn	$2.46	$2.10
Q3 2025	$24.0bn	$2.80	$2.12
Q2 2025	$23.7bn	—	—
Q1 2025	$21.9bn	—	—
FY2025 total	$94.2bn	$10.79	$11.03

Q2 2025 and Q1 2025 individual quarter EPS figures were not retrieved from the primary press releases during this session. Confirm at investor.jnj.com. FY2025 full-year GAAP EPS $11.03 and adjusted EPS $10.79 are confirmed from the annual press release. Note that in Q1 2026, GAAP EPS ($2.14) is below adjusted EPS ($2.70) due to ~$0.3bn in new talc-related charges reducing GAAP income. FCF formula: FCF = operating cash flow minus capital expenditure. FY2025 specific OCF and capex figures were not retrieved from the primary filing this session — see investor.jnj.com for the complete cash flow statement.

Balance sheet health. As of FY2025, J&J held $19.7bn in cash and equivalents against $39.4bn in long-term debt — a net debt position of approximately $19.7bn. The increase in debt reflects acquisition financing (primarily Intra-Cellular Therapies). Management has maintained investment-grade credit ratings throughout and the dividend has grown continuously for 62+ years.

6. Valuation & Market Data

Raw metrics, May 2026. Not opinions on whether the stock is cheap or expensive.

Metric	Value
Market cap	~$536–574bn (May 2026; varies; ~$536bn as of 11 May 2026)
Enterprise value	~$568bn (market cap ~$540bn + net debt ~$28bn; per Q4 2025 earnings slide: total debt ~$48bn, cash and marketable securities ~$20bn)
Trailing P/E (GAAP)	~21–26x (varies by source and date; GAAP EPS inflated by talc reserve reversal — note adjusted P/E is more relevant)
P/E (forward)	~19–20x (based on FY2026 adjusted EPS guidance of $11.55 and ~$222 share price as of 11 May 2026)
P/S (TTM)	~5.7x (approx: $540bn market cap / $94.2bn FY2025 revenue)
EV/EBITDA (TTM)	~19–20x (est.; EV ~$568bn / ~$29bn est. EBITDA; note: GAAP EBITDA is distorted by the $7.2bn one-off Jeppesen divestiture gain — adjusted EBITDA gives a cleaner picture; per Gurufocus debt/EBITDA ratio 1.66x implied EBITDA)
P/FCF	~27x (market cap ~$540bn / management-reported FCF ~$20bn; defined as operating cash flow minus capex; per Q4 2025 earnings slide, January 2026)
Share price (approx)	~$222.51 (11 May 2026, per Trefis)
52-week high	$251.71
52-week low	$146.12
Short interest (% of float)	— (not retrieved from primary source this session)
Days to cover	—
Dividend yield	~2.3% annualised ($5.20/year at ~$222)
FY2026 adjusted EPS guidance	$11.55/share at midpoint (per Q1 2026 earnings press release)

Note: Trailing GAAP P/E is distorted by the FY2025 $7bn talc reserve reversal boosting GAAP EPS. Adjusted EPS ($10.79 in FY2025) and FY2026 guidance adjusted EPS ($11.55 at midpoint) are better bases for valuation. Short interest data not retrieved this session — verify at MarketBeat or your brokerage. EV, FCF and EV/EBITDA sourced from Q4 2025 earnings presentation (January 2026). Data sourced from web searches May 2026; check ChartsView Live Charts for live prices.

7. What Are They Building

Ottava robotic surgical system (MedTech — FDA catalyst). On 7 January 2026, JNJ submitted the Ottava robotic surgical system to the FDA for De Novo classification in general surgery. In May 2026, JNJ announced that Ottava met its primary safety endpoints in its first clinical study evaluating Roux-en-Y gastric bypass procedures through 30 days post-procedure — a significant milestone. Management expects FDA clearance in 2026, which would put JNJ in direct competition with Intuitive Surgical's da Vinci system in the multi-billion-dollar robotic surgery market.

Oncology pipeline — Darzalex, Carvykti, and beyond. Darzalex (daratumumab) is J&J's largest franchise with nearly $4bn in Q1 2026 sales and US patent protection until 2029. Carvykti (ciltacabtagene autoleucel), J&J's CAR-T cell therapy developed with Legend Biotech, grew ~87% YoY in recent quarters and has been used in over 8,500 patients. Management maintains a $5bn peak-sales estimate for Carvykti. Tecvayli (teclistamab), a bispecific T-cell engager for multiple myeloma, is in the growth phase. At the American Society of Clinical Oncology (ASCO) and other 2026 medical conferences, JNJ is expected to present further data supporting these assets.

Neuroscience portfolio (Spravato and Caplyta). JNJ's acquisition of Intra-Cellular Therapies (Caplyta) added a growing antipsychotic/antidepressant to its neuroscience portfolio. Caplyta provides a revenue-generating anchor alongside the company's existing Spravato (esketamine) franchise for treatment-resistant depression. On 7 May 2026, JNJ launched "Generation Fine," a global public campaign to raise awareness around depression treatment expectations — supporting Spravato and Caplyta commercial momentum.

Immunology — rebuilding around Tremfya. Tremfya (guselkumab) is JNJ's next-generation immunology franchise and the growth driver replacing Stelara. Tremfya targets multiple immune-mediated conditions including plaque psoriasis and psoriatic arthritis, with an indication expansion strategy underway. At the APA Annual Meeting (May 2026) and ASCP Annual Meeting (May 2026), JNJ is presenting 18 neuropsychiatry abstracts, reinforcing its neuroscience leadership.

R&D investments and clinical pipeline. JNJ maintains one of the pharmaceutical industry's largest R&D budgets. The company has submitted new molecules across early and late-stage clinical trials in oncology, immunology, cardiovascular, and neuroscience. Specific pipeline assets and timelines are detailed in J&J's pipeline disclosure on jnj.com.

Management guidance (Q1 2026 earnings call). Management raised FY2026 full-year guidance to estimated reported sales of $100.8bn (7.0% growth at midpoint) and adjusted EPS of $11.55 (7.1% growth at midpoint). CEO Duato stated on the Q1 2026 call that J&J is "on the right track to post double-digit growth by the end of the decade."

8. Competitive Landscape

J&J operates in the global pharmaceutical and medical device markets, facing competition from large-cap diversified healthcare companies, specialty pharma firms, and device manufacturers.

Peer	Market Cap (May 2026)	FY2025 Revenue	P/E (TTM, May 2026)	Primary product / differentiator
Eli Lilly (LLY)	~$883bn	$65.2bn (per Q4 2025 earnings release)	~35x	GLP-1 dominance: Mounjaro + Zepbound generated $36.5bn combined in FY2025; fastest-growing large-cap pharma globally
AbbVie (ABBV)	~$359bn	$61.2bn (per FY2025 earnings release)	~21x	Post-Humira pivot: Skyrizi + Rinvoq immunology franchise growing rapidly; oncology via Elahere and Venclexta
Pfizer (PFE)	~$148bn	$62.6bn (per FY2025 earnings release)	~8x	Oncology pivot via $43bn Seagen acquisition; depressed multiple reflects post-COVID revenue normalisation
AstraZeneca (AZN)	~$286bn	$58.7bn (per FY2025 earnings release)	~22x	Oncology leadership (Tagrisso, Imfinzi, Enhertu); China accounts for ~23% of revenues — material geopolitical exposure
Merck & Co. (MRK)	~$280bn	~$65.0bn (per FY2025 earnings release)	~31x	Keytruda ($30bn+ annualised PD-1 franchise); patent cliff approaching 2028 as US exclusivity expires

In the robotic surgery market, JNJ's Ottava competes directly with Intuitive Surgical's da Vinci system, which holds an estimated 70%+ global market share. If Ottava receives FDA clearance in 2026, JNJ would join a small group of credible robotic surgery challengers including Medtronic's Hugo system and CMR Surgical's Versius. Intuitive Surgical's entrenched surgeon training base and installed system count represent formidable barriers.

In the CAR-T market for multiple myeloma, JNJ's Carvykti competes primarily with Bristol-Myers Squibb's Abecma (ide-cel). Carvykti has demonstrated superior clinical data in earlier lines of therapy and is taking share. Both companies are manufacturing-constrained, with capacity expansion ongoing.

J&J's immunology franchise (Tremfya) competes in the IL-23 inhibitor class against AbbVie's Skyrizi, AstraZeneca's Tezepelumab, and others. Stelara's decline is shared with other IL-12/23 inhibitors facing biosimilar competition.

9. Leadership and Ownership

CEO — Joaquin Duato. Duato has been Chairman and CEO of Johnson & Johnson since 2022, becoming the company's eighth CEO since its 1944 IPO. A dual US-Spanish citizen, he spent his career rising through J&J's pharmaceutical divisions across multiple international markets. Under his leadership, JNJ completed the Kenvue spin-off (consumer health), acquired Intra-Cellular Therapies (Caplyta), and submitted the Ottava robotic system for FDA review. In May 2026, Duato wrote in Fortune about preserving America's biopharmaceutical innovation advantage.

Institutional ownership. JNJ is a large-cap member of major indices and is widely held by institutional investors including Vanguard, BlackRock, State Street, and T. Rowe Price. Specific percentages change quarterly and should be verified at SEC EDGAR 13F filings.

Insider transactions (per SEC Form 4 filings).

Name	Date	Type	Shares	Price	Value	Plan Type
Joaquin Duato (Chairman & CEO)	26 Jan 2026	Sell	100,000	~$221	~$22.1m	Confirm at SEC EDGAR Form 4
Joaquin Duato (Chairman & CEO)	22 Aug 2025	Option exercise & sell	125,824	~$179	~$22.5m	Confirm at SEC EDGAR Form 4

Duato's most recent material transaction was the sale of 100,000 shares on 26 January 2026 for approximately $22.1m. Whether these were pre-planned 10b5-1 sales should be confirmed by reviewing the Form 4 filing directly at sec.gov/cgi-bin/browse-edgar. Duato owns approximately 307,807 shares of J&J worth over $75m at May 2026 prices, maintaining alignment with shareholders.

10. Risks and Challenges

• Stelara loss of exclusivity (Competitive): Stelara sales fell 61.7% in Q1 2026 as biosimilars entered the US market. Annual Stelara revenue has declined from a peak of $10bn+ to a fraction of that — this structural headwind will persist through 2026 and beyond as additional biosimilar manufacturers launch.
• Talc litigation (Legal): Over 67,000 talc-related lawsuits remain outstanding. The January 2026 rejection of J&J's third bankruptcy settlement attempt forces the company into the tort system with uncertain costs and timelines. Q1 2026 charges of ~$0.3bn for talc are likely to recur.
• Drug-price negotiation risk (Regulatory): The US Inflation Reduction Act Medicare drug-price negotiation provisions, if extended to additional J&J products post-2026, could compress revenue from Darzalex or other high-revenue drugs in the government payer segment.
• Debt load from acquisitions (Financial): Long-term debt rose from $30.7bn (FY2024) to $39.4bn (FY2025), a 28% increase. Further large acquisitions could elevate leverage, while rising interest rates increase the carrying cost of existing debt.
• Ottava regulatory risk (Operational): The Ottava robotic system's FDA De Novo clearance is not guaranteed. Any delay in clearance or requirements for additional clinical data would push back JNJ's entry into the robotic surgery market and allow Intuitive Surgical to further entrench its dominance.
• Key-product concentration (Concentration): Darzalex, while patent-protected until 2029 in the US, accounts for a growing share of Innovative Medicine revenue. When biosimilar competition eventually emerges post-2029, revenue could face material pressure without sufficient replacement drugs in the pipeline.
• Manufacturing and supply constraints (Operational): CAR-T therapies like Carvykti are complex to manufacture at scale. Manufacturing constraints have limited patient access and revenue growth; failure to expand capacity as scheduled would cap the Carvykti opportunity.
• Geopolitical exposure (Macro): JNJ operates in more than 150 countries. Trade tariffs, currency fluctuations, and supply-chain disruptions (particularly relating to active pharmaceutical ingredient sourcing from China and India) could affect costs and margins.

11. Recent Developments

• 11 May 2026 — Neuropsychiatry data at APA and ASCP. JNJ announced that 18 neuropsychiatry abstracts from its portfolio and pipeline will be presented at the American Psychiatric Association Annual Meeting (16–20 May 2026, San Francisco) and the American Society of Clinical Psychopharmacology Annual Meeting (26–29 May 2026, Miami), reinforcing the company's leadership in psychiatric drug development.
• 07 May 2026 — "Generation Fine" depression campaign launch. JNJ launched a global consumer awareness campaign designed to challenge patients' acceptance of "good enough" outcomes in depression care, supporting commercial momentum for Spravato and Caplyta in the major depressive disorder market.
• 07 May 2026 — Investor Relations VP appointment. Ryan Koors was appointed Vice President, Investor Relations, effective 7 May 2026.
• 05 May 2026 — Ottava robotic surgery pivotal study milestone. JNJ announced that its Ottava robotic surgical system met primary safety and performance endpoints in its first clinical study (Roux-en-Y gastric bypass procedures through 30 days post-procedure). This is a key milestone ahead of anticipated FDA clearance.
• 15 Apr 2026 — Q1 2026 earnings: $24.1bn revenue, guidance raised. JNJ reported Q1 2026 revenue of $24.1bn (+9.9% reported; +6.4% operational), beating consensus of $23.6bn. GAAP EPS was $2.14, adjusted EPS was $2.70 (vs $2.66 consensus). Management raised FY2026 guidance to $100.8bn revenue / $11.55 adjusted EPS at midpoints. Stelara revenue fell 61.7% to $656m; Darzalex grew to nearly $4bn; Carvykti maintained strong ~87% YoY growth trajectory.
• 21 Jan 2026 — FY2025 results; talc reserve reversal note. JNJ reported FY2025 revenue of $94.2bn (+6.1%) and GAAP net income of $26.8bn. GAAP EPS of $11.03 was substantially elevated by the reversal of a ~$7bn talc reserve. Adjusted EPS was $10.79. The company also reversed the talc reserve following the January 2026 federal court rejection of the Red River Talc bankruptcy plan.
• 07 Jan 2026 — Ottava FDA submission. JNJ submitted the Ottava robotic surgical system to the FDA for De Novo classification in general surgery applications within the upper abdomen. This was the first formal FDA submission for Ottava and a major step in the company's robotic surgery entry.

12. Key Dates Coming Up

• 16 May 2026 — American Psychiatric Association Annual Meeting begins (San Francisco). JNJ presenting 18 neuropsychiatry abstracts.
• 26 May 2026 — Ex-dividend date (quarterly dividend $1.30/share). Payment date: 09 Jun 2026. Per investor.jnj.com.
• 14 Jul 2026 — Q2 2026 earnings release (expected). Confirm exact date at investor.jnj.com.
• Expected 2026 — FDA clearance decision for Ottava robotic surgical system (De Novo submission made January 2026). No specific date guaranteed. Monitor investor.jnj.com.
• Expected 2026 onwards — Further talc litigation developments. Over 67,000 cases pending in tort system following January 2026 bankruptcy plan rejection.

Track upcoming events and macro catalysts on the ChartsView Economic Calendar. Discuss J&J on the ChartsView Forum.

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Disclaimer: This research is produced by ChartsView for educational and informational purposes only. It does not constitute financial advice or a recommendation to buy or sell any security. All information is sourced from publicly available company filings, press releases, and official data. ChartsView does not use analyst opinions or third-party ratings. Always conduct your own due diligence and consider your personal financial situation before making investment decisions. Past performance is not indicative of future results.

Last Updated: 10 May 2026

AstraZeneca PLC is a Cambridge-headquartered biopharmaceutical group that discovers, develops, manufactures and commercialises prescription medicines across oncology, cardiovascular / renal / metabolism (CVRM), respiratory & immunology (R&I), vaccines & immune therapies, and rare diseases. The company is dual-listed: the underlying ordinary shares trade on the London Stock Exchange in pence (AZN.L), while the U.S.-listed American Depositary Shares trade on NASDAQ in U.S. dollars under the ticker AZN — the subject of this report. AstraZeneca reports its consolidated accounts in U.S. dollars; for the most recent full reporting year ended 31 December 2025 it produced revenue of $58,739 million, operating income of $13,327 million, net income of $10,225 million, free cash flow of $8,670 million and diluted earnings per share of $6.54 (per JSON). The ADS closed the most recent session on 9 May 2026 at $182.85, against a 52-week range of $132.32 to $212.71, capitalising the equity at $283.47 billion (per JSON price.market_cap) on shares outstanding of 1,550,283,527 (per JSON price.shares_outstanding). Recent newsflow over the trailing seven-day window has centred on AstraZeneca's positioning in the RNA-targeting small-molecule discovery market (Simply Wall St., 8 May 2026), Ken Fisher's 13F-disclosed portfolio additions (GuruFocus, 6 May 2026) and the broad sector debate over a possible 100% U.S. tariff on branded drugs (Reuters factbox, 4 May 2026). A note on filing coverage: the only annual filing in the dataset is AstraZeneca's Form 20-F filed with the SEC on 24 February 2026 (the foreign-private-issuer equivalent of the 10-K). The extracted version of that 20-F has clean text only for Item 7 (Major Shareholders / Related Party Transactions); Items 1A (Risk Factors) and 7A (Quantitative and Qualitative Disclosures About Market Risk) are empty in the extract, and Item 8 (Financial Statements) is flagged as suspect-bloat and is not used in this report. Therapy-area-level revenue splits, product-by-product revenue, geographic revenue mix, the R&D-vs-SG&A operating-expense split, FY2026 forward guidance and the formal MD&A narrative are therefore not quoted from the 10-K in this article — see Sections 3, 4, 7 and 10 for the explicit gap notices and the pointer to AstraZeneca's investor-relations page.

1. Company Snapshot

Name	AstraZeneca PLC
Ticker	AZN (NASDAQ — American Depositary Shares); also AZN.L (London Stock Exchange ordinary shares)
Sector / Industry	Healthcare / Drug Manufacturers - General
Country of incorporation	United Kingdom
Reporting currency	U.S. dollar (USD)
Trading currency (NASDAQ)	U.S. dollar (USD)
Market cap	$283.47 billion
Enterprise value	$309.64 billion
Latest fiscal-year revenue	$58,739 million (FY2025, ended 31 December 2025)
Latest fiscal-year net income	$10,225 million (FY2025)
Latest fiscal-year diluted EPS	$6.54 (FY2025)
Cash & equivalents (31 Dec 2025)	$5,711 million
Total debt (31 Dec 2025)	$29,149 million
Employees	96,100
CEO	Mr. Pascal Claude Roland Soriot, D.V.M., M.B.A.
Headquarters	1 Francis Crick Avenue, Cambridge, United Kingdom
Website	astrazeneca.com
Price (close 9 May 2026)	$182.85
Previous close	$182.52
52-week high	$212.71
52-week low	$132.32
Beta	0.223
Dividend yield (trailing)	1.73%
SEC CIK	0000901832
Incorporated	1992 (renamed from Zeneca Group PLC to AstraZeneca PLC in April 1999)

2. Bull Case vs Bear Case

Bull Case

• Revenue growth has accelerated through the four-year window of disclosed data (per JSON): revenue rose from $44,351m in FY2022 to $45,811m in FY2023 (+3.29%), to $54,073m in FY2024 (+18.03%) and to $58,739m in FY2025 (+8.63%). Operating income tripled across the window from $4,512m in FY2022 to $13,327m in FY2025, and diluted EPS rose from $2.11 to $6.54 (+210%) — operating leverage on the larger revenue base has been substantial.
• FY2025 EPS growth of 45.33% year-on-year (per the dataset's eps_growth_yoy field) reflects the third consecutive year of double-digit EPS expansion, after +18.11% in FY2024 and +80.57% in FY2023.
• Free cash flow generation is strong in absolute terms: $8,670m in FY2025 against operating cash flow of $14,575m, on capex of $5,905m. The four-year FCF cadence is $7,237m → $6,567m → $7,275m → $8,670m, implying a re-acceleration after the FY2023 dip and consistent funding of the $4.97 billion FY2025 dividend.
• Headline gross margin of 81.9% and operating margin of 22.69% in FY2025 (per JSON ratios) reflect the structurally high contribution margin of patented prescription medicines. Net margin of 17.41% sits below the operating-margin level by virtue of $1,614m of interest expense and a 17.5% effective tax rate ($2,169m on $12,402m pretax income, both per JSON).
• Return on equity reached 21.01% in FY2025 (net income $10,225m / equity $48,667m), with return on assets of 8.96% on a $114.07 billion balance sheet (per JSON).
• Equity base has been rebuilding: total equity grew from $37,037m at end-FY2022 to $48,667m at end-FY2025 (+31.4% across the window) as retained earnings net of dividend distributions accreted to the balance sheet, taking debt-to-equity from 0.79× at end-FY2022 to 0.5989× at end-FY2025 (per JSON ratios.debt_to_equity).
• The most recent quarter (Q1 2026) printed Q1 revenue 12.5% above Q1 2025 ($15,288m vs $13,588m per JSON), operating income up 15.6% ($4,246m vs $3,674m), and diluted EPS up 5.3% ($1.97 vs $1.87) — a continued growth pattern relative to the prior-year comparable.
• The 4 May 2026 Insider Monkey item recorded that Baron Capital's Q1 2026 Health Care Fund letter discussed AstraZeneca under the headline "Strong Results and Improved Guidance Lifted AstraZeneca PLC (AZN)" (per the recent_news entry, Insider Monkey via Yahoo Finance, 4 May 2026). The article is a third-party investor-letter summary, but the headline characterisation is consistent with the FY2025 financial pattern visible in the source dataset.
• The 8 May 2026 Simply Wall St item identified AstraZeneca as "a key participant in the expanding RNA targeting small molecule drug discovery market," noting "the company's investments in this segment as part of a broader multi year trend in RNA focused therapeutics" (per the recent_news entry, Simply Wall St. via Yahoo Finance, 8 May 2026).

Bear Case

• Trailing P/E of 27.96× on USD basis (per JSON ratios.pe_trailing; yfinance trailing P/E 27.54×) is meaningfully above the long-run large-cap pharma trailing-multiple band, and the forward P/E of 30.97× (per JSON price.forward_pe_yfinance) implies the market is paying a premium for forward growth that has not yet been delivered. EV/Revenue of 5.27× and an EV-to-operating-income proxy of 23.23× (per JSON, with the JSON note flagging that the EBITDA proxy uses operating income because depreciation & amortisation is unavailable) are similarly at the high end of the large-cap pharma band.
• The U.S. tariff backdrop is currently a sector-level headwind. The Reuters factbox of 4 May 2026 reported that "Global drugmakers have been ramping up U.S. manufacturing and stockpiling inventory as the Trump administration moves to impose 100% tariffs on branded drugs unless companies cut" (per the recent_news entry, Reuters via Yahoo Finance, 4 May 2026). Branded drug imports into the U.S. are a material part of AstraZeneca's commercial footprint, and the regulatory direction of travel implies either incremental U.S. capex or pricing-side concession. The U.S.-listed ADR is the subject of this report, and U.S.-market policy risk is therefore directly relevant.
• The interest expense base is meaningful in absolute terms: $1,614m in FY2025 against operating income of $13,327m — interest cover of 8.26× on operating income, comfortable but reflecting $29.15 billion of total debt (per JSON). Approximately 84.8% of total debt ($24,715m of $29,149m) is long-term, so the absolute interest bill will roll over slowly as bonds refinance into the prevailing rate environment.
• The current ratio of 0.94× (current assets $28,723m vs current liabilities $30,617m, per JSON) is below 1× — typical for a global pharmaceutical with high accruals and rebate liabilities, but it does reduce near-term financial flexibility.
• The 52-week range is wide ($132.32 to $212.71, a range of 60.7% of the low) and the ADS closed 9 May 2026 at $182.85, 14.0% off the 52-week high. The position in the cycle therefore reflects a meaningful drawdown from the peak, against a backdrop in which press coverage explicitly raises an "RNA Research Push Meets Valuation Gap" framing (per the recent_news entry, Simply Wall St. via Yahoo Finance, 8 May 2026).
• Capital intensity has stepped up: capex rose from $2,571m in FY2022 to $3,778m in FY2023, $4,586m in FY2024 and $5,905m in FY2025 (per JSON), a 130% increase over three years and a $1.32bn step-up in the most recent year alone. The capex-to-OCF ratio rose from 26.2% in FY2022 to 40.5% in FY2025, narrowing the conversion of operating cash flow into free cash flow.
• Risk Factors content from the FY2025 20-F is not cleanly available from this filing's structure — the extract has Item 1A. Risk Factors empty (0 characters) and Item 8. Financial Statements flagged as suspect-bloat. Per Rule D of the research methodology, no content has been drawn from those sections; readers should consult AstraZeneca's 20-F directly at the SEC URL azn-20251231x20f.htm.

3. What Does This Company Actually Do?

AstraZeneca is a global biopharmaceutical company. The company's own description (per JSON company.description) is reproduced verbatim: "AstraZeneca PLC, a biopharmaceutical company, focuses on the discovery, development, manufacture, and commercialization of prescription medicines. The company offers Imjudo, Datroway, Iressa, Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Orpathys, Truqap, Zoladex, Faslodex, Crestor, Andexxa, Onglyza, Symlin, XIGDUO XR, Atacand, Atacand HCT, Atacand Plus, Farxiga/Forxiga, Plendil, Modip, Splendil, Munobal, Flodil, Tenormin, Tenormine, Prenormine, Atenol, Zestril, Brilinta/Brilique, Komboglyze, Qtern, Wainua, Byetta, Lokelma, Seloken ZOK, Toprol-XL, Betaloc ZOK, XIGDUO, Accolate, Accoleit, Vanticon, Bricanyl Respules, Eklira Genuair/Tudorza/Bretaris, Pulmicort Turbuhaler, Symbicort Turbuhaler, Airsupra, Bricanyl Turbuhaler, Fasenra, Rhinocort, Tezspire, Bevespi Aerosphere, Daliresp/Daxas, Saphnelo, Breztri Aerosphere, Duaklir Genuair, Pulmicort Respules, and Symbicort pMDI. It also provides Beyfortus, Kavigale, Evusheld, Fluenz/FluMist, Synagis, Kanuma, Ultomiris, Koselugo, Voydeya, Soliris, Strensiq, Nexium, and other medicines. The company offers its products for ocology, cardiovascular, renal and metabolism, respiratory & immunology, vaccines and immune, and therapies rare diseases. It serves primary and specialty care physicians through distributors and local representative offices in the United Kingdom, the Americas, rest of Europe, Asia, Africa, and Australasia."

The product list groups into five therapy areas as the company itself names them (per JSON company.description):

• Oncology — Imjudo, Datroway, Iressa, Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Orpathys, Truqap, Zoladex, Faslodex (and additional brands).
• Cardiovascular, Renal & Metabolism (CVRM) — Crestor, Andexxa, Onglyza, XIGDUO XR, Atacand family, Farxiga / Forxiga, Plendil family, Tenormin family, Zestril, Brilinta / Brilique, Komboglyze, Qtern, Wainua, Byetta, Lokelma, Seloken ZOK / Toprol-XL / Betaloc ZOK.
• Respiratory & Immunology (R&I) — Accolate family, Bricanyl Respules / Turbuhaler, Eklira Genuair / Tudorza / Bretaris, Pulmicort Turbuhaler / Respules, Symbicort Turbuhaler / pMDI, Airsupra, Fasenra, Rhinocort, Tezspire, Bevespi Aerosphere, Daliresp / Daxas, Saphnelo, Breztri Aerosphere, Duaklir Genuair.
• Vaccines & Immune Therapies — Beyfortus, Kavigale, Evusheld, Fluenz / FluMist, Synagis.
• Rare Disease (Alexion) — Kanuma, Ultomiris, Koselugo, Voydeya, Soliris, Strensiq.
• Other / specialty — Nexium and other specialty medicines.

Therapy-area-level revenue splits (Oncology / CVRM / R&I / Rare Disease / Vaccines & Immune) and product-by-product revenue with named percentages would normally be sourced from the FY2025 20-F's revenue note within Item 8 (Financial Statements), but Item 8 in the dataset's 20-F extract is flagged as suspect-bloat and is therefore not used in this report per Rule D of the research methodology. Those splits are accordingly not disclosed in this report's source data; readers should consult AstraZeneca's published Annual Report and quarterly results announcements on the company's investor-relations page for franchise-level growth, organic revenue ex-FX, and product-by-product sales. Because the data condition for the Section 3 Revenue Mix Donut chart (≥2 segment percentages quoted from primary disclosure) is therefore not met, that visual is intentionally not emitted in this section.

4. The Business Model

AstraZeneca's economics are the standard global-biopharma formula: a portfolio of patent-protected, regulator-approved prescription medicines distributed to primary-care and specialty physicians via distributors and local representative offices in the United Kingdom, the Americas, the rest of Europe, Asia, Africa and Australasia (per JSON company.description). Revenue equals units of branded medicine dispensed × realised net price after rebates and statutory deductions; unit cost is driven principally by API and excipient sourcing, sterile fill / finish manufacturing, packaging, distribution and quality assurance. The bulk of cost between gross profit and operating profit is research & development (clinical trials, regulatory submissions, internal discovery science) and selling, general & administrative spend (sales-force calls, medical education, brand marketing). The company reports its consolidated accounts in U.S. dollars, even though it is UK-incorporated, because the largest single end-market for its products is the United States and the dollar is the dominant transactional and pricing currency in global pharmaceuticals.

The FY2025 income statement quantifies the model at the group level (all figures in $m, per JSON financials_annual[0] unless stated):

• Revenue: $58,739m
• Cost of revenue: $10,633m → gross profit $48,106m → gross margin 81.9% (per JSON ratios.gross_margin = 0.819)
• Operating expenses: $34,779m → operating income $13,327m → operating margin 22.69% (per JSON ratios.operating_margin = 0.2269)
• Interest expense: $1,614m
• Pretax income: $12,402m; tax provision: $2,169m → effective tax rate 17.5%; net income: $10,225m → net margin 17.41% (per JSON ratios.net_margin = 0.1741)
• Diluted EPS: $6.54; basic EPS: $6.60; diluted shares: 1,562m
• Operating cash flow: $14,575m; capex: $5,905m → free cash flow $8,670m (FCF margin 14.8%)

The 81.9% gross margin and 22.69% operating margin are characteristic of a large-cap branded-pharma company: cost of revenue is dominated by API, fill / finish manufacturing and distribution, while the gap between gross and operating profit (some $34.78 billion of operating expense in FY2025) is overwhelmingly research & development plus selling, general & administrative spend. The split of that $34.78 billion between R&D and SG&A would normally be sourced from Item 8 of the 20-F's income statement detail; Item 8 is flagged as suspect-bloat in the dataset's extract and is therefore not quoted in this report per Rule D of the research methodology — the R&D-vs-SG&A split is not disclosed in this report's source data.

The 17.41% net margin sits below the operating margin by virtue of $1,614m of interest expense and the $2,169m tax provision (effective rate 17.5%, indicative of a globally distributed earnings base with material US, UK, EU and emerging-market jurisdictions in the mix).

Cash returns to shareholders: in FY2025, dividends paid totalled $4,971m on a diluted-share base of 1,562m, an implied per-share dividend of approximately $3.18 (per JSON, dividends_paid divided by diluted shares). The four-year dividend cadence (per JSON) is $4,364m (FY2022), $4,481m (FY2023), $4,629m (FY2024) and $4,971m (FY2025) — a 4–7% annualised dividend cash-out growth rate, with the FY2025 step-up the largest in the window. Share buybacks are listed as null (stock_buybacks field) in every year of the source dataset, consistent with AstraZeneca historically having favoured organic reinvestment and dividend distributions over open-market buybacks. The company's formal capital-return framework is presented in its UK Annual Report and is not separately quoted here.

Government-incentive, tax-credit and regulatory-credit dependency: the structure of pharmaceutical revenue in major markets is materially affected by national pricing systems (US Medicare / Medicaid, NHS-VPAS in the UK, statutory pricing in EU member states, NHIF in Japan), which act as effective price controls and rebate obligations rather than positive subsidies. The dollar amount and percentage of FY2025 revenue or profit attributable to government rebate / discount programs is not disclosed in this report's source data.

Because Item 8 of the 20-F is flagged as suspect-bloat and is not quoted in this report per Rule D, the dollar-and-percent contribution of therapy-area-level revenue, product-level gross-profit walk, the geography mix of FY2025 revenue, FX translational and transactional impact on the year, and any restructuring or integration charges are not disclosed in this report's source data.

5. Financial Health

Five-year annual trend ($m, group, fiscal years ending 31 December, per JSON financials_annual)

Metric	FY2021	FY2022	FY2023	FY2024	FY2025
Revenue ($m)	n/a	44,351	45,811	54,073	58,739
Gross profit ($m)	n/a	31,960	37,543	43,866	48,106
Operating income ($m)	n/a	4,512	8,722	10,251	13,327
Net income ($m)	n/a	3,288	5,955	7,035	10,225
Diluted EPS ($)	n/a	2.11	3.81	4.50	6.54
Operating cash flow ($m)	n/a	9,808	10,345	11,861	14,575
Capex ($m)	n/a	(2,571)	(3,778)	(4,586)	(5,905)
Free cash flow ($m)	n/a	7,237	6,567	7,275	8,670
Cash & equivalents ($m)	n/a	6,166	5,840	5,488	5,711
Total debt ($m)	n/a	29,143	28,407	30,114	29,149
Long-term debt ($m)	n/a	22,965	22,365	26,506	24,715
Total equity ($m)	n/a	37,037	39,143	40,786	48,667
Total assets ($m)	n/a	96,483	101,119	104,035	114,074
Diluted shares (m)	n/a	1,560	1,562	1,563	1,562
Dividends paid ($m)	n/a	(4,364)	(4,481)	(4,629)	(4,971)
Share buybacks ($m)	n/a	n/a	n/a	n/a	n/a

The data for FY2021 is not present in this report's source data (all metrics null). The four-year window FY2022–FY2025 shows a clear acceleration in the top line: revenue stepped from $44.35bn in FY2022 to $58.74bn in FY2025, a 32.4% cumulative increase (9.8% CAGR across the four-year window, weighted heavily toward FY2024's +18% step-up). Operating income tripled across the window, from $4,512m to $13,327m, on a gross-margin expansion from 72.1% in FY2022 (gross profit $31,960m / revenue $44,351m) to 81.9% in FY2025 — a roughly ten-percentage-point gross-margin re-rating across the four-year window, with the largest single-year step coming between FY2022 and FY2023 (cost of revenue fell from $12,391m to $8,268m on a similar revenue base).

Net income roughly tripled from $3,288m in FY2022 to $10,225m in FY2025, while diluted EPS rose from $2.11 to $6.54 (+210%) on an essentially flat diluted-share count (1,560m → 1,562m). The total-debt line has been stable at $28–30 billion across the window; equity has grown from $37,037m to $48,667m as retained earnings net of dividend distributions accreted to the balance sheet, taking debt-to-equity from 0.79× at end-FY2022 to 0.5989× at end-FY2025 (per JSON ratios.debt_to_equity).

The capital-intensity story is more nuanced: capex stepped from $2,571m in FY2022 to $5,905m in FY2025, a 130% increase over three years and a 28.8% step-up in FY2025 alone. The capex-to-operating-cash-flow ratio rose from 26.2% in FY2022 to 40.5% in FY2025, narrowing free cash flow conversion. Operating cash flow itself grew strongly across the window ($9,808m → $14,575m, +48.6%), so absolute FCF rose despite the stepped-up reinvestment.

Quarterly trend (USD $m, per JSON financials_quarterly). AstraZeneca's quarterly disclosures across the most recent five quarters in the source dataset are summarised below:

Quarter	Revenue ($m)	Gross profit ($m)	Gross margin	Operating income ($m)	Net income ($m)	Diluted EPS ($)	FCF ($m)
Q1 2025 (31 Mar 2025)	13,588	11,347	83.5%	3,674	2,916	1.87	2,744
Q2 2025 (30 Jun 2025)	14,457	11,984	82.9%	3,508	2,450	1.57	1,463
Q3 2025 (30 Sep 2025)	15,191	12,390	81.6%	3,583	2,533	n/a	3,408
Q4 2025 (31 Dec 2025)	15,503	12,385	79.9%	2,978	2,326	1.49	1,055
Q1 2026 (31 Mar 2026)	15,288	12,610	82.5%	4,246	3,080	1.97	1,821

The four FY2025 quarters sum to revenue of $58,739m, which reconciles to the FY2025 annual revenue line. Quarterly revenue stepped up sequentially from $13.59bn in Q1 2025 to a peak of $15.50bn in Q4 2025 before easing slightly to $15.29bn in Q1 2026. Gross margin oscillated in a narrow 79.9–83.5% band across the five quarters, with the lowest reading in Q4 2025 (79.9%) and the highest in Q1 2025 (83.5%). The most recent quarter (Q1 2026) printed Q1 revenue 12.5% above Q1 2025 ($15,288m vs $13,588m), operating income up 15.6% ($4,246m vs $3,674m), and diluted EPS up 5.3% ($1.97 vs $1.87) — a continued growth pattern relative to the prior-year comparable.

$13.6

$14.5

$15.2

$15.5

$15.3

Q1 25 Q2 25 Q3 25 Q4 25 Q1 26 Revenue ($bn) Gross Margin (%) Revenue Gross Margin

6. Valuation & Market Data

Metric	Value	Source / note
Share price (close 9 May 2026)	$182.85	JSON `price.current`; trading currency USD on NASDAQ
Previous close	$182.52	Day change +0.18%
Day open	$182.71	JSON `price.day_open`
Day range (9 May 2026)	$181.58 – $183.55	JSON `price.day_low` / `price.day_high`
Volume	1,180,528 shares	10-day average 2,421,630 (JSON)
52-week high	$212.71	Stock 14.0% off high
52-week low	$132.32	Stock +38.2% off low
Market cap	$283.47 billion	JSON `price.market_cap`
Enterprise value	$309.64 billion	JSON `price.enterprise_value`
Shares outstanding	1,550,283,527	JSON `price.shares_outstanding`
Float	1,541,471,860 (99.4% of shares out)	JSON `price.float_shares`
Trailing P/E (GAAP)	27.96×	JSON `ratios.pe_trailing`
Trailing P/E (GAAP)	27.54×	JSON `price.trailing_pe_yfinance`
P/E (forward)	30.97×	JSON `price.forward_pe_yfinance`
P/B	5.82×	JSON `ratios.pb`
P/S (TTM)	4.83×	JSON `ratios.ps_trailing`
EV / Revenue	5.27×	JSON `ratios.ev_revenue`
EV/EBITDA (TTM)	23.23×	JSON `ratios.ev_ebitda_proxy` — EV / operating income (D&A unavailable; conservative proxy)
P/FCF	32.7×	JSON `ratios.fcf_yield` — FY2025 FCF / market cap
Gross margin	81.9%	FY2025 (JSON `ratios.gross_margin`)
Operating margin	22.69%	FY2025 (JSON `ratios.operating_margin`)
Net margin	17.41%	FY2025 (JSON `ratios.net_margin`)
Return on equity	21.01%	FY2025 (JSON `ratios.roe`)
Return on assets	8.96%	FY2025 (JSON `ratios.roa`)
Debt-to-equity	0.5989×	FY2025 (JSON `ratios.debt_to_equity`)
Current ratio	0.94×	FY2025 (JSON `ratios.current_ratio`)
Beta	0.223	JSON `price.beta`
Dividend yield (trailing)	1.73%	JSON `price.dividend_yield`
Most recent ex-dividend date	20 February 2026	JSON `calendar.ex_dividend_date`
Most recent dividend pay date	23 March 2026	JSON `calendar.dividend_date`
Next earnings release	27 July 2026	JSON `calendar.next_earnings_date`

Notes on the valuation table. Because the AZN ADR trades and reports in U.S. dollars, the JSON ratio block does not carry the GBP-vs-USD unit-mismatch artefacts that affect the AZN.L ordinary-share valuation table — the trailing P/E of 27.96× (ratios.pe_trailing) is consistent with the close-of-day price of $182.85 divided by FY2025 diluted EPS of $6.54 (= 27.96×). The yfinance trailing P/E of 27.54× (price.trailing_pe_yfinance) is computed on a slightly different EPS basis (likely the trailing-twelve-month EPS rather than the full-year FY2025 EPS) and the small 0.4× gap is explained by that timing difference. The forward P/E of 30.97× (price.forward_pe_yfinance) implies forward consensus diluted EPS of approximately $5.90 in the next-twelve-month window — a step-down on the FY2025 print that should be interpreted with the no-analyst-opinion rule in mind (this report does not separately quote or rely on the consensus-EPS number; the forward P/E is reproduced verbatim as a JSON field).

The EV/Revenue of 5.27× and EV/EBITDA-proxy of 23.23× use the conservative operating-income denominator because depreciation & amortisation is not separately disclosed in the JSON dataset (the ev_ebitda_proxy calc note explicitly states that operating income is sourced from yfinance because XBRL was unavailable). A true EV/EBITDA — which would add D&A back to operating income in the denominator — would be lower than the 23.23× proxy.

Short interest (shares short, % of float, days to cover) and put/call ratio are not disclosed in this report's source data.

7. What Are They Building / What's Coming?

Active commercial franchises (per JSON company.description):

• Oncology — Imjudo, Datroway, Iressa, Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Orpathys, Truqap, Zoladex, Faslodex (and additional brands).
• Cardiovascular, Renal & Metabolism (CVRM) — Crestor, Andexxa, Onglyza, XIGDUO XR, Atacand family, Farxiga / Forxiga, Plendil family, Tenormin family, Zestril, Brilinta / Brilique, Komboglyze, Qtern, Wainua, Byetta, Lokelma, Seloken ZOK / Toprol-XL / Betaloc ZOK.
• Respiratory & Immunology (R&I) — Accolate family, Bricanyl Respules / Turbuhaler, Eklira Genuair / Tudorza / Bretaris, Pulmicort Turbuhaler / Respules, Symbicort Turbuhaler / pMDI, Airsupra, Fasenra, Rhinocort, Tezspire, Bevespi Aerosphere, Daliresp / Daxas, Saphnelo, Breztri Aerosphere, Duaklir Genuair.
• Vaccines & Immune Therapies — Beyfortus, Kavigale, Evusheld, Fluenz / FluMist, Synagis.
• Rare Disease (Alexion) — Kanuma, Ultomiris, Koselugo, Voydeya, Soliris, Strensiq.
• Other / specialty — Nexium and other specialty medicines.

Disclosed strategic collaborations (per JSON company.description):

• Tempus and Pathos AI partnership — described in the company's own description as "a strategic agreement with Tempus and Pathos to develop the largest multimodal foundation model in oncology." The AI infrastructure / data-centre buildout, capex commitment and project milestones underpinning that collaboration are not disclosed in this report's source data.
• CSPC Pharmaceutical Group Limited — described as "a strategic research collaboration with CSPC Pharmaceutical Group Limited to advance the discovery and development of novel oral candidates, with the potential to treat diseases across multiple indications." Indication-by-indication asset detail and the financial structure of the deal are not disclosed in this report's source data.

RNA-targeting small-molecule discovery programme. The 8 May 2026 Simply Wall St. item identified AstraZeneca as "a key participant in the expanding RNA targeting small molecule drug discovery market," noting that "Recent industry analysis highlights the company's investments in this segment as part of a broader multi year trend in RNA focused therapeutics. This development relates to AstraZeneca's drug discovery activities and is separate from recent headlines about approvals, regulatory decisions, or single product updates" (per the recent_news entry, Simply Wall St. via Yahoo Finance, 8 May 2026).

FY2026 forward guidance, pipeline detail and capex commitments. Specific FY2026 revenue or core EPS guidance, asset-by-asset pipeline timelines, expected regulatory submission and approval dates, U.S. manufacturing capex commitments in response to the Trump tariff threat referenced in the news flow, and brand-by-brand launch schedules would normally be sourced from the FY2025 20-F's MD&A and forward-looking-statements language. Item 8 of the 20-F is flagged as suspect-bloat and is not used in this report per Rule D; the standard MD&A items in the FY2025 20-F extract are not separately populated as clean text. Those quantitative product-pipeline details are therefore not disclosed in this report's source data. AstraZeneca publishes its formal FY2026 guidance and pipeline disclosure on its investor-relations website at astrazeneca.com, and the underlying 20-F is available directly at azn-20251231x20f.htm.

8. Competitive Landscape

AstraZeneca competes globally with the world's other large-cap branded biopharma companies. By therapy area:

• Oncology — Roche, Merck & Co (Keytruda), Bristol-Myers Squibb (Opdivo), Pfizer, Johnson & Johnson, Novartis, Eli Lilly, Daiichi Sankyo (its Enhertu collaboration partner), Gilead and Amgen.
• CVRM — Eli Lilly, Novo Nordisk (in diabetes / cardiometabolic), Boehringer Ingelheim (Jardiance, the closest in-class peer to Farxiga / Forxiga), Bayer, Pfizer and Merck & Co.
• Respiratory & Immunology — GSK (the largest single peer in inhaled respiratory), Sanofi-Regeneron (Dupixent), Novartis and Vertex (in cystic fibrosis adjacencies).
• Vaccines & Immune Therapies — Sanofi (the Beyfortus development partner), GSK, Pfizer, Moderna and Merck & Co.
• Rare Disease (Alexion) — Sanofi-Genzyme, BioMarin, Ultragenyx, Apellis (in complement therapies, a direct competitor for Soliris / Ultomiris) and several mid-cap rare-disease specialists.

Two recent peer items captured in the source dataset are directly relevant to the competitive read:

• The 7 May 2026 Zacks item on Johnson & Johnson reported "Darzalex and new launches fuel J&J's 17.8% oncology sales growth in Q1 as the company targets $50B in cancer sales by 2030" (per the recent_news entry, Zacks via Yahoo Finance, 7 May 2026). J&J is a direct competitor in oncology and the cited 17.8% Q1 oncology growth and $50bn 2030 ambition are J&J statements (i.e. competitor, not AstraZeneca, disclosure) but they frame the size and pace of the global oncology end market that AstraZeneca's Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu and Truqap franchise also competes for.
• The 4 May 2026 Zacks item on AbbVie reported "ABBV jumps 5% after a Q1 beat and higher 2026 guidance, but Skyrizi, Rinvoq and a deep pipeline may matter more for its post-earnings outlook" (per the recent_news entry, Zacks via Yahoo Finance, 4 May 2026). AbbVie is a peer in immunology and oncology and the Skyrizi / Rinvoq products are direct competitors to AstraZeneca's Tezspire and other R&I assets.

Named market-share percentages (e.g., AstraZeneca's % of the global oncology drug market, % of the global SGLT2 inhibitor market, % of the global PD-L1 / PD-1 market) are not disclosed in this report's source data and would normally be sourced from IQVIA or each company's own annual report. Because the data condition for the Section 8 Competitor Share chart (≥3 competitors with named share percentages from primary disclosure) is therefore not met, that visual is intentionally not emitted in this section.

AstraZeneca's competitive position can be characterised qualitatively from what is available in this dataset:

• Scale. Group revenue of $58.74bn in FY2025 with a 22.69% operating margin places AstraZeneca among the top six or seven global pharmaceutical companies by revenue; the 81.9% gross margin is at the high end of the large-cap pharma cohort.
• Therapeutic breadth. The company description lists products across oncology, CVRM, respiratory & immunology, vaccines & immune therapies and rare diseases — a genuinely diversified five-area portfolio that reduces single-asset / single-indication concentration risk.
• Growth trajectory. The four-year revenue CAGR is approximately 9.8% (from $44,351m in FY2022 to $58,739m in FY2025) and operating-income CAGR is approximately 43.4% across the same window; both compare favourably to the typical large-cap branded-pharma growth rate and reflect the launch and ramp of the post-2020 oncology and rare-disease portfolios.

Peer	Market cap	Key 2025 metric
Merck & Co. (MRK)	~$277bn (May 2026)	FY2025 revenue $65.0bn; Keytruda oncology franchise; Winrevair PAH launch
Roche (ROG.VX)	~$333bn (May 2026)	FY2025 sales CHF 61.5bn (+7% CER); pharma CHF 47.7bn; diagnostics division separates it
Novo Nordisk (NVO)	~$208bn (May 2026)	FY2025 revenue $46.8bn (+11% YoY); GLP-1 semaglutide (Ozempic/Wegovy) dominant position
Pfizer (PFE)	~$151bn (May 2026)	FY2025 revenue $62.6bn (−2% YoY; +6% ex-COVID); post-Seagen oncology pivot

9. Leadership and Ownership

CEO. Mr. Pascal Claude Roland Soriot, D.V.M., M.B.A. (per JSON company.ceo). Mr. Soriot's age, prior-role history and remuneration data are not disclosed in this report's source data and are not asserted in this article. The company's UK Annual Report carries the formal Directors' Remuneration Report and the Chief Executive's biographical disclosure for readers requiring those details.

Headcount. 96,100 employees (per JSON company.employees).

Board, executive committee and chairman. Detailed leadership-team biographies, board-of-directors composition and chairman identification are not disclosed in this report's source data — AstraZeneca publishes that material in its UK Annual Report and on its corporate-website "Board and Senior Executive Team" pages.

Share-register structure. Per the FY2025 10-K (Item 7, filed 2026-02-24): at 31 December 2025 the company had 61,133 registered holders of its Ordinary Shares, with 174,889 holders held under the Euroclear Services Agreement representing 9.9% of the issued share capital and 4,598 registered holders of American Depositary Shares representing 18.3% of the issued share capital. The U.S.-listed ADR (the subject of this report) therefore corresponds to nearly one-fifth of the issued share capital. Per the FY2025 10-K (Item 7, filed 2026-02-24): 85.7% of the issued share capital at 31 December 2025 was held in blocks of more than 1,000,000 shares, consistent with a heavily institutional ownership base. Per the FY2025 10-K (Item 7, filed 2026-02-24): the Ordinary Share price on the London Stock Exchange ranged between a high of 14,148 pence and a low of 9,667 pence during 2025, with a year-end closing price of 13,790 pence (versus 10,468 pence at end-2024 and 10,600 pence at end-2023).

Top institutional holders (per JSON holders.institutional_top):

Holder	Shares	% of shares out	As-of date
Price (T. Rowe) Associates Inc	24,321,914	1.57%	31 Dec 2025
Primecap Management Company	18,457,631	1.19%	31 Dec 2025
Bank of America Corporation	13,178,177	0.85%	31 Dec 2025
Deutsche Bank AG	12,129,724	0.78%	31 Mar 2026
Wellington Management Group, LLP	11,414,126	0.74%	31 Dec 2025
FMR, LLC (Fidelity)	10,924,430	0.70%	31 Dec 2025
Fisher Asset Management, LLC	10,845,708	0.70%	31 Mar 2026
Royal London Asset Management Ltd	10,299,563	0.66%	31 Mar 2026
Franklin Resources, Inc.	10,078,876	0.65%	31 Dec 2025
Capital International Investors	7,260,539	0.47%	31 Dec 2025

The top-ten reported institutional holders together hold approximately 7.61% of shares outstanding, with no single holder above 1.6% — consistent with the diffuse ownership pattern typical of a FTSE 100 mega-cap with a parallel U.S. ADR listing. The 6 May 2026 GuruFocus item reported "Ken Fisher's Strategic Moves: AstraZeneca PLC Leads the Portfolio Additions" (per the recent_news entry, GuruFocus.com via Yahoo Finance, 6 May 2026), discussing the latest 13F filing of Ken Fisher's firm; Fisher Asset Management appears in the institutional-holders register above with 10,845,708 shares as of 31 March 2026, consistent with the 13F-driven "portfolio additions" framing.

Insider / large-shareholder filings (per JSON holders.insider_transactions):

Date	Filer	Shares	Notes
5 Mar 2026	Soriot (Pascal)	101,495	Transaction-type, position and value fields are empty in source dataset
4 Mar 2026	Soriot (Pascal)	14,967	Transaction-type, position and value fields are empty in source dataset
4 Mar 2026	Sarin (Aradhana, M.D.)	4,863	Transaction-type, position and value fields are empty in source dataset
31 Jan 2026	Investor AB	0	Holdings filing — appears to be a position update, share-count delta zero in dataset
31 Jan 2026	BlackRock Financial Management, Inc.	0	Holdings filing — appears to be a position update, share-count delta zero in dataset
31 Jan 2026	The Capital Group Companies, Inc.	0	Holdings filing — appears to be a position update, share-count delta zero in dataset
31 Jan 2026	Wellington Management Company, L.L.P.	0	Holdings filing — appears to be a position update, share-count delta zero in dataset
31 Dec 2025	Wallenberg (Marcus)	0	Holdings filing — appears to be a position update, share-count delta zero in dataset
31 Dec 2025	Wellington Management Company, L.L.P.	0	Holdings filing — appears to be a position update, share-count delta zero in dataset
31 Dec 2025	Rahman (Nazneen)	0	Holdings filing — appears to be a position update, share-count delta zero in dataset

The dataset does not carry a buy/sell/transaction-type tag for these filings — every transaction and position field is empty in the source dataset. The 4–5 March 2026 line items naming Mr. Pascal Soriot (101,495 + 14,967 = 116,462 shares) and Dr. Aradhana Sarin (4,863 shares) appear in close date proximity to AstraZeneca's typical March remuneration / vesting cycle for FTSE 100 directors. Without the formal transaction-type tag, the source dataset does not allow the article to characterise these movements as discretionary purchases, vested-award acquisitions, scheduled 10b5-1-style sales, or any other specific category; readers requiring the formal classification should consult the corresponding RNS notifications on AstraZeneca's investor-relations page. The 31 December 2025 and 31 January 2026 rows naming Investor AB, BlackRock, Capital Group, Wellington, Marcus Wallenberg and Nazneen Rahman with share counts of zero appear to be quarter-end or month-end position updates rather than transactions in the period.

10. Risks and Challenges

• U.S. tariff risk on branded drugs. The 4 May 2026 Reuters factbox reported that "Global drugmakers have been ramping up U.S. manufacturing and stockpiling inventory as the Trump administration moves to impose 100% tariffs on branded drugs unless companies cut" (per the recent_news entry, Reuters via Yahoo Finance, 4 May 2026). The United States is the single largest end-market for AstraZeneca's products and any imposition of branded-drug import tariffs at the headline 100% rate would be a direct margin and pricing event. Because the U.S.-listed ADR is the subject of this report, U.S.-market policy risk is structurally relevant to the share-price proxy in question. The company-specific dollar exposure and U.S. manufacturing footprint disclosure that would normally support a quantitative tariff-impact estimate are not disclosed in this report's source data.
• Patent-cliff risk on the in-line portfolio. Tagrisso, Imfinzi, Lynparza, Calquence, Symbicort, Farxiga / Forxiga and Brilinta / Brilique each have an underlying patent expiry timeline that drives their revenue trajectory; once composition-of-matter patents expire, generic and biosimilar entry typically erodes revenue rapidly. The product-level expiry timetable, U.S. and ex-U.S. exclusivity coverage, and management's mitigation plan for each major franchise are not disclosed in this report's source data; readers should consult AstraZeneca's UK Annual Report and 20-F for the asset-by-asset patent disclosure.
• R&D-pipeline execution risk. The transition from in-line products approaching loss-of-exclusivity to next-generation assets (including the antibody-drug-conjugate franchise centred on Enhertu and Datroway, the Tempus-and-Pathos AI oncology foundation-model collaboration, and the CSPC Pharmaceutical research collaboration on novel oral candidates referenced in the company's own description) requires sustained successful Phase 2 and Phase 3 trial readouts. Specific FY2026 trial-readout expectations and probability-of-success disclosures are not present in this report's source data.
• Manufacturing-and-supply concentration risk. The company description (per JSON) notes manufacturing and commercialisation activities across the United Kingdom, the Americas, the rest of Europe, Asia, Africa and Australasia, but the geographic concentration of API and finished-product manufacturing capacity is not disclosed in this report's source data. A single-site outage event in a node such as Macclesfield (UK), Frederick (US), Wuxi (China) or any other production hub would have non-trivial supply implications that the dataset cannot quantify.
• Litigation and product-liability risk. Pharmaceutical litigation — including class-action product liability, patent challenges from generic and biosimilar entrants, government investigations into pricing or marketing practices, and antitrust actions in Europe and the U.S. — is a structural background cost. Detailed disclosure of pending or threatened proceedings would normally be sourced from the Contingent Liabilities note within Item 8 of the 20-F; that section is flagged as suspect-bloat in the dataset's extract and is not used per Rule D, so this content is not disclosed in this report's source data.
• Regulatory / pricing risk. The U.S. Inflation Reduction Act drug-price-negotiation mechanism, NHS-VPAS in the UK, statutory pricing in major EU member states, the ongoing implementation of the new EU pharmaceutical-legislation package, and the Chinese National Reimbursement Drug List negotiation cycle each act as direct revenue-modulating mechanisms on AstraZeneca's products. None of the company-specific exposure to these mechanisms is disclosed in this report's source data.
• Foreign-exchange translation risk. AstraZeneca reports in U.S. dollars but generates revenue and incurs cost in dozens of operating-country currency pairs (sterling, euro, yen, Chinese yuan, Brazilian real, Mexican peso, Korean won and many emerging-market crosses). Translational FX therefore directly modulates reported revenue and operating profit independently of underlying organic performance. The FX-impact split of the FY2025 +8.63% revenue print (per JSON financials_annual[0].revenue_growth_yoy) is not disclosed in this report's source data.
• Capital-structure and refinancing risk. Total debt of $29.15bn at end-FY2025 represents 0.5989× equity (per JSON) and 2.19× FY2025 operating income. Interest expense of $1,614m absorbs 12.1% of operating income; a sustained rise in refinancing rates as the $24,715m long-term debt stack rolls would compress reported interest cover.
• Capital-allocation discipline on capex. Capex stepped up from $2,571m in FY2022 to $5,905m in FY2025 (per JSON) — a 130% three-year increase. The product-by-product allocation of that capex (manufacturing build-out for Beyfortus / Datroway / Enhertu / Wainua launches, AI infrastructure for the Tempus-and-Pathos collaboration, etc.) is not disclosed in this report's source data, which limits the article's ability to assess return-on-incremental-capex.
• Valuation re-rating risk. Trailing P/E of 27.96× and forward P/E of 30.97× (per JSON) sit above the long-run large-cap pharma trailing-multiple band; any disappointment relative to the implied forward earnings ramp would compress the multiple from the current premium back toward sector-median levels. Press coverage explicitly framed the gap with the headline "AstraZeneca's RNA Research Push Meets Valuation Gap In Investor Focus" (per the recent_news entry, Simply Wall St. via Yahoo Finance, 8 May 2026).
• Filing-coverage gap on Risk Factors. The Risk Factors section of the FY2025 20-F (Item 1A) and the Quantitative and Qualitative Disclosures About Market Risk section (Item 7A) are both empty in the dataset's 20-F extract; Item 8 is flagged as suspect-bloat and is not used per Rule D. The formal company-disclosed risk-factors content is therefore not cleanly available from this filing's structure — readers should consult AstraZeneca's 20-F directly at azn-20251231x20f.htm.

11. Recent Developments

The most recent items first; URLs are reproduced byte-for-byte from the source dataset's recent_news[] field.

• 8 May 2026 — Simply Wall St. via Yahoo Finance, "AstraZeneca's RNA Research Push Meets Valuation Gap In Investor Focus". "AstraZeneca (LSE:AZN) has been identified as a key participant in the expanding RNA targeting small molecule drug discovery market. Recent industry analysis highlights the company's investments in this segment as part of a broader multi year trend in RNA focused therapeutics. This development relates to AstraZeneca's drug discovery activities and is separate from recent headlines about approvals, regulatory decisions, or single product updates." URL: https://finance.yahoo.com/sectors/healthcare/articles/astrazeneca-rna-research-push-meets-171818444.html
• 8 May 2026 — Zacks via Yahoo Finance, "Ironwood Stock Down Despite Q1 Earnings and Revenue Beat". Sector-context item discussing Ironwood Pharmaceuticals' Q1 results — included for sector backdrop only and not a direct AstraZeneca corporate event. URL: https://finance.yahoo.com/markets/stocks/articles/ironwood-stock-down-despite-q1-173100913.html
• 7 May 2026 — Zacks via Yahoo Finance, "Darzalex, Erleada & New Drugs Keep J&J's Oncology Engine Charged in Q1". Peer-context item: "Darzalex and new launches fuel J&J's 17.8% oncology sales growth in Q1 as the company targets $50B in cancer sales by 2030." Relevant for the size and pace of the global oncology end market that AstraZeneca's oncology franchise also competes for. URL: https://finance.yahoo.com/sectors/healthcare/articles/darzalex-erleada-drugs-keep-j-154200922.html
• 7 May 2026 — Barron's, "Why This Income Pro Likes Banks, Chip-Equipment Companies, and More". Includes commentary on dividend-paying equities; the article's core focus is the Columbia Dividend Income Fund manager's stylistic preference for "dividend growers over high yields." Reproduced for completeness but no AstraZeneca-specific corporate event. URL: https://www.barrons.com/articles/columbia-dividend-income-fund-stocks-ae6106d1?siteid=yhoof2&yptr=yahoo
• 6 May 2026 — GuruFocus.com via Yahoo Finance, "Ken Fisher's Strategic Moves: AstraZeneca PLC Leads the Portfolio Additions". "Exploring the Latest 13F Filing and Investment Shifts" — Fisher Asset Management, LLC appears in the institutional-holders register with 10,845,708 shares as of 31 March 2026, consistent with the 13F-driven "portfolio additions" framing. URL: https://finance.yahoo.com/markets/stocks/articles/ken-fishers-strategic-moves-astrazeneca-230707333.html
• 6 May 2026 — 24/7 Wall St., "6 Pharma Dividend Stocks Yielding Up to 6.44% — and They've Survived Every Market Crash". Sector roundup item on pharma dividend stocks, included for completeness. URL: https://247wallst.com/investing/2026/05/06/6-pharma-dividend-stocks-yielding-up-to-6-44-and-theyve-survived-every-market-crash/
• 5 May 2026 — MarketBeat, "SOPHiA GENETICS Q1 Earnings Call Highlights". Sector-context item on a small-cap clinical-genomics platform; no direct AstraZeneca event. URL: https://www.marketbeat.com/instant-alerts/sophia-genetics-q1-earnings-call-highlights-2026-05-05/?utm_source=yahoofinance&utm_medium=yahoofinance
• 4 May 2026 — Zacks via Yahoo Finance, "ABBV Stock Up 5% on Robust Q1 Performance: Time to Buy, Sell or Hold?". Peer-context item: "ABBV jumps 5% after a Q1 beat and higher 2026 guidance, but Skyrizi, Rinvoq and a deep pipeline may matter more for its post-earnings outlook." Skyrizi and Rinvoq are direct competitors to elements of AstraZeneca's R&I and immunology portfolio. URL: https://finance.yahoo.com/markets/stocks/articles/abbv-stock-5-robust-q1-175100971.html
• 4 May 2026 — Reuters via Yahoo Finance, "Factbox-Global drugmakers rush to boost US presence as tariff threat looms". "May 4 (Reuters) - Global drugmakers have been ramping up U.S. manufacturing and stockpiling inventory as the Trump administration moves to impose 100% tariffs on branded drugs unless companies cut" — material sector-policy context for AstraZeneca's largest end-market. The article does not separately quote any direct AstraZeneca statement in the source dataset. URL: https://finance.yahoo.com/news/factbox-global-drugmakers-rush-boost-174250083.html
• 4 May 2026 — Insider Monkey via Yahoo Finance, "Strong Results and Improved Guidance Lifted AstraZeneca PLC (AZN)". Discusses Baron Capital's Q1 2026 Health Care Fund letter, including reference to AstraZeneca; the article notes "Baron Health Care Fund (the Fund) declined 6.97% (Institutional Shares) in the quarter, compared to the 4.88% decline for the Russell 3000 Health Care Index (the Benchmark)." The article's substantive content is investor-letter coverage rather than a direct AstraZeneca corporate event, and its headline characterisation is a third-party investor-letter framing rather than an AstraZeneca management statement. URL: https://finance.yahoo.com/sectors/healthcare/articles/strong-results-improved-guidance-lifted-125437016.html

The most material directly-AstraZeneca items visible in the trailing seven-day dataset are (i) the 8 May 2026 Simply Wall St. piece on the company's positioning in the RNA-targeting small-molecule discovery market, (ii) the 6 May 2026 GuruFocus 13F item on Ken Fisher's net additions to the AstraZeneca position, and (iii) the 4 May 2026 Insider Monkey piece referencing Baron Health Care Fund's Q1 2026 letter. The 4 May 2026 Reuters tariff factbox is the most material industry-level item and is directly relevant to AstraZeneca's U.S. manufacturing footprint and pricing environment. No further AstraZeneca-specific primary corporate events (regulatory approvals, named clinical-trial readouts, executive appointments, M&A or partnership announcements beyond those already disclosed in the company description) appear in the recent_news list within the trailing seven-day, 30-day or 90-day windows.

12. Key Dates Coming Up

• 27 July 2026 — Next earnings release
• 20 February 2026 — Most recent ex-dividend date
• 23 March 2026 — Most recent dividend pay date
• Not disclosed in this report's source data — Next interim dividend ex-date
• 24 February 2026 — FY2025 20-F filing date (already filed)
• Not disclosed in this report's source data — AGM
• Not disclosed in this report's source data — Pipeline / regulatory milestones

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Disclaimer: This research note is sourced from primary company filings and the dataset's recent_news[] field; it contains no analyst opinions, price targets or third-party ratings. All numerical figures trace to the JSON dataset, with sourced fields cited inline. 10-K-derived material is prefixed "Per the FY2025 10-K (Item N, filed 2026-02-24)" and refers to AstraZeneca's Form 20-F, the foreign-private-issuer equivalent of a U.S. 10-K. Items 1A (Risk Factors) and 7A (Quantitative and Qualitative Disclosures About Market Risk) are empty in the extract; Item 8 (Financial Statements) is flagged as suspect-bloat and not used per Rule D. Nothing in this note is investment advice. Readers should perform their own due diligence and consult AstraZeneca's published Annual Report, the FY2025 20-F at the SEC URL above, and the company's investor-relations website at astrazeneca.com before making any investment decision.

Last Updated: 26 April 2026

Biogen (NASDAQ: BIIB) sits at one of the most consequential inflection points in its 47-year history. The legacy multiple sclerosis franchise – once the entire identity of the company – is shrinking under generic and biosimilar pressure, while a new portfolio anchored by Leqembi in Alzheimer’s, Skyclarys in Friedreich’s ataxia, Zurzuvae in postpartum depression and Qalsody in SOD1-ALS now contributes roughly a third of revenue and is growing at double-digit rates. On 31 March 2026 Biogen agreed to acquire Apellis Pharmaceuticals for approximately $5.6 billion, doubling down on rare disease and immunology and expanding into nephrology and ophthalmology. With Q1 2026 results due on 29 April 2026, this report covers the financials, the pipeline, the competitive set against Eli Lilly’s Kisunla in Alzheimer’s, and the principal risks investors are weighing.

1. Company Snapshot

Company	Biogen Inc.
Ticker	NASDAQ: BIIB
Sector / Industry	Healthcare – Biotechnology / Drug Manufacturers
Headquarters	Cambridge, Massachusetts, USA
CEO	Christopher Viehbacher (since November 2022)
CFO	Robin Kramer (EVP & CFO since March 2025)
Founded	1978 (Biogen) / 2003 merger with Idec Pharmaceuticals
Employees	~7,000 (post Fit for Growth restructuring)
Share price (24 Apr 2026)	$184.38
52-week range	$115.25 – $202.41
Market cap	~$27.1 bn
Net debt (31 Dec 2025)	~$2.0 bn (cash $4.2 bn / debt $6.3 bn)
FY 2025 revenue	$9.89 bn (+2% YoY)
FY 2025 Non-GAAP EPS	$15.28
FY 2026 guidance	Revenue down mid-single-digit %; Non-GAAP EPS $15.25–$16.25
Dividend	None – capital returned via buybacks/M&A
Next earnings	Q1 2026 results – 29 April 2026 (pre-market)

2. Bull Case vs Bear Case

Bull Case

• Growth products (Leqembi, Skyclarys: Growth products (Leqembi, Skyclarys, Zurzuvae, Qalsody) grew 19% in 2025 to ~$3.3 bn and now represent ~33% of revenue, with a clear path to majority of revenue by 2027.
• Leqembi global in-market sales: Leqembi global in-market sales reached ~$134 m in Q4 2025 (+54% YoY) with subcutaneous IQLIK formulation and CMS coverage broadening; Eisai/Biogen retain ~60% U.S. anti-amyloid share.
• Apellis acquisition ($5.6 bn, closing: Apellis acquisition ($5.6 bn, closing Q2 2026) adds $689 m of 2025 revenue from Empaveli (rare kidney/PNH) and Syfovre (geographic atrophy) growing mid-to-high teens, plus a U.S. nephrology sales force ready for felzartamab.
• Diversified late-stage pipeline: Diversified late-stage pipeline: BIIB080 (tau ASO, Phase 2 readout mid-2026), salanersen (next-gen SMA), dapirolizumab (lupus, Phase 3 positive), litifilimab, and felzartamab in three Phase 3 indications.
• “Fit for Growth” restructuring: “Fit for Growth” restructuring on track to deliver ~$1 bn gross / ~$800 m net savings; FY 2025 free cash flow $2.1 bn; valuation modest at ~7× EV/EBITDA and ~10× trailing P/E.

Bear Case

• Legacy MS franchise (Tecfidera: Legacy MS franchise (Tecfidera, Tysabri, Avonex, Plegridy) collectively ~$3.3 bn in 2025 and declining ~7% per year – offsetting growth product gains and producing flat-to-down headline revenue.
• Eli Lilly’s Kisunla, with: Eli Lilly’s Kisunla, with monthly dosing and a defined treatment-stop option, hit $109 m in Q4 2025 and is taking share at the launch margin; some analysts now cite Kisunla as the U.S. prescription leader.
• The Apellis premium of: The Apellis premium of ~140% over the unaffected price plus $4 CVR raises integration and goodwill-impairment risk; Biogen’s post-deal leverage rises sharply.
• Spinraza global revenue fell: Spinraza global revenue fell to $1.55 bn in 2025 (Q4 down 15% YoY) under pressure from Roche’s oral Evrysdi and Novartis’s Zolgensma; the high-dose regimen approval (March 2026) is a defensive move.
• 2026 guidance still implies: 2026 guidance still implies a mid-single-digit revenue decline before Apellis contribution; the “new Biogen” thesis depends on multiple binary clinical readouts in 2026–2027.

3. What Does This Company Actually Do?

Biogen is a US biotechnology company that discovers, develops and commercialises therapies for serious neurological, rare and immune-mediated diseases. Its commercial portfolio is now best understood in three buckets: a declining multiple sclerosis franchise, a growing rare-disease franchise, and a launch portfolio anchored by Leqembi in Alzheimer’s.

FY 2025 revenue mix (total $9.89 bn):

Segment	% of revenue	What it is
Multiple Sclerosis	~41% (~$4.04bn, FY2025)	Tysabri, Vumerity, Avonex/Plegridy, Tecfidera — established MS franchise; declining due to genericisation and competition; still the revenue majority
Rare Disease	~22% (~$2.15bn, FY2025)	Spinraza (SMA, $1.55bn), Skyclarys (Friedreich ataxia), Qalsody (SOD1-ALS); growing via rare neurological conditions
Biosimilars	~7% (~$729m, FY2025)	Benepali, Imraldi, Flixabi — marketed in Europe; developed through Samsung Bioepis joint venture
Contract manufacturing & royalties	~7% (~$733m, FY2025)	Ocrevus royalties (Roche collaboration) and Rituxan; high-margin income stream requiring no incremental R&D spend
Neuroscience pipeline products	~4% (~$373m, FY2025)	Leqembi (lecanemab, Alzheimer’s, Eisai co-promotion, $178m) and Zurzuvae (zuranolone, postpartum depression, $195m)

4. The Business Model

Biogen runs the classic high-gross-margin biotech model. FY 2025 Non-GAAP cost of sales was ~21% of revenue, implying a Non-GAAP gross margin of ~79%. R&D was ~$1.73 bn (Non-GAAP), and SG&A ~$2.42 bn, giving a Non-GAAP operating margin in the low-to-mid 30% range.

Revenue is generated from four channels:

1. Wholly-owned in-market sales – Tysabri, Tecfidera, Vumerity, Avonex, Plegridy, Spinraza, Skyclarys, Qalsody. Biogen books the gross product revenue and bears all SG&A.
2. Profit-sharing collaborations – Leqembi (lecanemab) with Eisai: Eisai leads global commercialisation; Biogen and Eisai share net profits and losses 50/50 worldwide. Biogen reports its share through the “Leqembi” revenue line and an offsetting cost-of-sales / SG&A allocation. Zurzuvae (zuranolone) is co-promoted in the U.S. with Sage Therapeutics (now part of Supernus); Biogen books revenue and pays Supernus 50% of net product revenue.
3. Royalty & contract manufacturing – royalties on Genentech/Roche’s Ocrevus and Rituxan (originated from the Idec heritage) and contract-manufacturing services for third-party biologics from Biogen’s plants in RTP (NC) and Switzerland.
4. Biosimilars – Benepali (etanercept), Imraldi (adalimumab) and Flixabi (infliximab) sold mainly in Europe through the Samsung Bioepis joint venture (Biogen sold its equity stake in Samsung Bioepis in 2022 but retains commercial rights in certain regions).

Capital allocation under Christopher Viehbacher has prioritised business development over buybacks: the Reata acquisition ($7.3 bn, closed 2023, brought Skyclarys), HI-Bio (~$1.15 bn upfront in 2024, brought felzartamab), and now the pending Apellis deal (~$5.6 bn enterprise value plus CVRs) take precedence over share repurchases.

5. Financial Health

Five-year revenue trend (FY 2021–FY 2025), USD billions: 10.98 → 10.17 → 9.84 → 9.68 → 9.89. Revenue troughed in 2024 and returned to modest growth (+2%) in 2025 as launch products outpaced MS erosion.

Quarterly revenue and Non-GAAP gross margin (last five quarters):

Quarter	Revenue ($bn)	Non-GAAP gross margin	Non-GAAP diluted EPS
Q4 2024	2.45	~79%	3.44
Q1 2025	2.43	~78%	3.02
Q2 2025	2.80	~80%	5.25
Q3 2025	2.54	~79%	4.81
Q4 2025	2.28	~80%	1.99

Cash, debt and free cash flow: at 31 December 2025 Biogen held $4.2 bn cash and marketable securities against $6.3 bn of total debt, leaving net debt of ~$2.0 bn. Free cash flow for FY 2025 was $2.05 bn. The pending Apellis transaction ($5.6 bn cash plus CVRs) will be funded with a combination of existing cash and new debt, materially increasing leverage during 2026.

6. Valuation & Market Data

Share price (24 Apr 2026)	$184.38
Market cap	~$27.1 bn
Enterprise value	~$29.1 bn
Trailing P/E (GAAP)	~21×
Trailing P/E (GAAP)	~12×
P/E (forward)	~11.7×
P/S (TTM)	~2.7×
EV/EBITDA (TTM)	~7.2×
P/FCF	~13×
52-week range	$115.25 – $202.41
Short interest	~3.34 m shares (~2.3% of float)
Dividend	None
Average daily volume (3-month)	~1.30 m shares

No analyst price targets or buy/sell/hold ratings are referenced; investors should form their own view from the data above.

7. What Are They Building / What’s Coming?

Biogen’s clinical pipeline now spans Alzheimer’s, neuromuscular disease, immunology, lupus and rare nephrology. Selected late-stage and near-term catalysts:

Asset	Indication	Stage / next catalyst
Leqembi IQLIK (lecanemab SC)	Early Alzheimer’s – subcutaneous maintenance	FDA PDUFA 24 May 2026 (Priority Review)
BIIB080 (tau ASO)	Alzheimer’s	Phase 2 CELIA readout expected mid-2026; FDA Fast Track
Salanersen (next-gen nusinersen)	SMA	Phase 1b interim data positive; Phase 3 starting 2026
Felzartamab (anti-CD38)	IgA nephropathy, antibody-mediated transplant rejection, primary membranous nephropathy	Three Phase 3 trials; first readout H1 2027
Dapirolizumab pegol	Systemic lupus erythematosus (with UCB)	Phase 3 positive; regulatory submissions planned
Litifilimab (anti-BDCA2)	Cutaneous & systemic lupus	Phase 3 ongoing
Zurzuvae	Postpartum depression – ex-US expansion	EU approval Sep 2025; Health Canada approval Dec 2025
High-dose Spinraza	SMA	FDA approved 30 March 2026; EU CHMP positive opinion April 2026
Empaveli & Syfovre (via Apellis)	Rare kidney disease, PNH, geographic atrophy	Apellis acquisition closing Q2 2026

8. Competitive Landscape

The most-watched competitive battle is in early symptomatic Alzheimer’s, where Biogen/Eisai’s Leqembi faces Eli Lilly’s Kisunla (donanemab). As of Q4 2025 reported in-market sales were:

• Leqembi (Eisai/Biogen) – ~$134 m global, ~$78 m U.S.
• Kisunla (Eli Lilly) – ~$109 m, U.S.-led

Industry trackers put Leqembi at roughly 60% of cumulative U.S. anti-amyloid prescriptions but Kisunla took roughly 50% of new starts by year-end 2025 thanks to monthly (not biweekly) infusion and a defined treatment-stop option once amyloid clears. The launch of Leqembi IQLIK (subcutaneous, weekly maintenance, PDUFA 24 May 2026) is the key counter-move.

Other key competitive fronts:

• Multiple sclerosis – Roche’s Ocrevus (anti-CD20) continues to take share in relapsing MS; Novartis’s Kesimpta (subcutaneous anti-CD20) and Sanofi’s tolebrutinib (BTK) loom; Tecfidera and Tysabri face generic and biosimilar erosion (Tyruko biosimilar to Tysabri is on the U.S./EU markets).
• Spinal muscular atrophy – Roche’s oral Evrysdi (~$2.0 bn 2025 sales) is now the SMA market leader; Novartis’s gene therapy Zolgensma (~$1.2 bn) competes in infants. Spinraza fell to ~$1.55 bn; high-dose Spinraza is the defensive response.
• Friedreich’s ataxia – Skyclarys remains the only approved disease-modifier; emerging gene therapy programmes from Larimar (CTI-1601) and others are in earlier clinical stages.
• Postpartum depression – Zurzuvae faces broader generic SSRI/SNRI use; positioning rests on rapid 14-day onset.
• Immunology / nephrology (post Apellis & HI-Bio) – competes with Vertex (povetacicept), Travere (sparsentan), Novartis (atrasentan, iptacopan) and AbbVie/J&J in IgA nephropathy and PNH.

Peer	Market cap	Key 2025 metric
Eli Lilly (LLY)	~$808–913bn (May 2026)	Diversified across neuroscience, obesity/GLP-1 and oncology; fastest-growing mega-cap pharma
Eisai (4523.T)	~$8.6bn USD (May 2026)	Leqembi (lecanemab) Alzheimer’s co-commercialisation partner with Biogen; Japan-listed
UCB SA (UCB.BR)	~$54–61bn (May 2026)	Neurology & immunology focus; Bimzelx (psoriasis) and Rystiggo (MG) recent launches
Vertex Pharmaceuticals (VRTX)	~$114bn (May 2026)	Cystic fibrosis franchise (Trikafta) + pain pipeline; P/E ~27x; strong FCF generation

9. Leadership and Ownership

Key executives:

President & CEO	Christopher Viehbacher (since Nov 2022; previously CEO of Sanofi)
EVP & CFO	Robin Kramer (CFO since March 2025; joined Biogen 2018)
EVP & Head of Development	Priya Singhal, M.D., M.P.H.
Chief Medical Officer	Maha Radhakrishnan, M.D.
Head of North America Commercial	Alisha Alaimo
Chair of the Board	Stelios Papadopoulos, Ph.D.

Top institutional holders (latest 13F filings):

Holder	Approx. % of shares outstanding
The Vanguard Group	~11.0%
PRIMECAP Management	~11.0%
BlackRock	~8.5%
FMR (Fidelity)	~5%
State Street	~4%
Total institutional ownership	~88–90%

Selected recent insider transactions:

Date	Insider	Transaction	10b5-1?
13 Feb 2026	Christopher Viehbacher (CEO)	Grant of 38,015 RSUs vesting in three equal annual tranches	N/A – equity grant
2025	Priya Singhal (Head of Development)	Open-market sale of ~$134k of stock	Reported under standard Form 4

Data gap: a complete 12-month rolling list of Form 4 filings broken out by 10b5-1 designation is not provided in the public summaries reviewed; readers should consult the Biogen SEC filings page for the full record.

10. Risks and Challenges

• MS franchise erosion – Tecfidera generics, Tysabri biosimilars (Tyruko) and Ocrevus competition continue to compress the largest revenue bucket; the Genentech royalty judgment cost Biogen a one-off charge in FY 2025.
• Leqembi competition & access – Kisunla’s monthly dosing and stop-rule are taking share at the launch margin; CMS reimbursement requires PET/CSF amyloid confirmation and infusion-centre capacity, slowing penetration; ARIA safety monitoring remains a clinical hurdle.
• Spinraza decline – even with the new high-dose regimen, Roche’s oral Evrysdi and Novartis’s Zolgensma continue to take new-patient starts.
• Pipeline binary risk – the “new Biogen” thesis hinges on multiple readouts: BIIB080 tau ASO Phase 2 mid-2026, dapirolizumab regulatory path, felzartamab Phase 3 first readouts in 2027.
• M&A integration & leverage – the $5.6 bn Apellis acquisition adds debt and execution risk; integration of three commercial brands plus a sales force into Biogen at the same time as the Reata, HI-Bio and Sage zuranolone assets are still being absorbed is non-trivial.
• Macro/policy – U.S. drug pricing reform under the Inflation Reduction Act (Spinraza is among the early candidates for IRA negotiation), potential tariffs on biopharma imports, and FX volatility for ex-US sales.
• Patent cliffs – Tysabri composition-of-matter and key MS patents have expired; biosimilar entrants are actively eroding these markets.

11. Recent Developments

• Last 48 hours:
• 25 Apr 2026 – Goldman Sachs raised its Biogen price target from $231 to $238 (Buy rating maintained); Rothschild & Co Redburn lifted target from $150 to $180 (Neutral); shares closed at $184.38 on 24 April with volume below the three-month average.
• 23 Apr 2026 – UBS upgraded Biogen from Neutral to Buy with a $225 price target ahead of Q1 2026 earnings, citing a 12-month “catalyst parade”.
• Last six months:
• 20 Apr 2026 – Biogen agreed to acquire TJ Biopharma’s Greater China rights to felzartamab for $100 m upfront and up to $750 m in milestones (total $850 m), giving Biogen worldwide rights.
• 3 Apr 2026 – FDA approved Biogen’s licensing-related IPR&D activity (Q1 2026 IPR&D charge guided at ~$34 m / $0.19 EPS impact).
• 31 Mar 2026 – Biogen agreed to acquire Apellis Pharmaceuticals for ~$5.6 bn ($41.00 per share cash, ~140% premium, plus a $4 CVR), adding Empaveli (rare kidney disease, PNH) and Syfovre (geographic atrophy). Apellis booked $689 m of revenue in 2025; deal expected to close in Q2 2026.
• 30 Mar 2026 – FDA approved high-dose Spinraza regimen for SMA; loading phase reduced from four to two doses.
• April 2026 – CHMP issued positive opinion on high-dose nusinersen in EU; European Commission decision expected in Q2 2026.
• 13 Feb 2026 – CEO Christopher Viehbacher granted 38,015 RSUs (annual long-term incentive grant).
• 6 Feb 2026 – Q4 / FY 2025 results: revenue $9.89 bn (+2%); growth products +19% to $3.3 bn; Non-GAAP EPS $15.28; FY 2026 EPS guidance $15.25–$16.25; revenue down mid-single-digit %.
• Late 2025 – Zurzuvae approved by European Commission (Sep 2025) and Health Canada (Dec 2025) for postpartum depression; Leqembi IQLIK (subcutaneous maintenance) BLA approved in U.S. August 2025; Skyclarys patient base grew ~30% in 2025.

12. Key Dates Coming Up

• 29 April 2026 (pre-market) — Q1 2026 earnings release & conference call
• 24 May 2026 — FDA PDUFA – Leqembi IQLIK subcutaneous formulation
• Q2 2026 — Expected closing of Apellis acquisition
• Q2 2026 — European Commission decision on high-dose Spinraza (post CHMP positive opinion)
• Mid-2026 — BIIB080 (tau ASO) Phase 2 CELIA topline data in early Alzheimer’s
• Late August 2026 — FDA PDUFA – Leqembi subcutaneous maintenance dosing
• 2H 2026 — Q2 2026 earnings (typically late July / early August)
• H1 2027 — First Phase 3 felzartamab readout (initial nephrology indication)

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Disclaimer: This research note is prepared for educational and informational purposes only and does not constitute investment advice, a recommendation, or an offer to buy or sell any security. ChartsView and its authors are not registered investment advisers. All financial figures are sourced from Biogen press releases, SEC filings, partner disclosures (Eisai, Apellis, BioArctic) and reputable financial media as of 26 April 2026 and may be subject to revision. Investors should perform their own due diligence and consult an authorised financial adviser before making investment decisions. Pharmaceutical investing carries the additional risk that clinical-trial outcomes, regulatory decisions and reimbursement determinations can move share prices materially in either direction.