Healthcare & Pharma

Last Updated: 23 June 2026

IDEXX Laboratories (Nasdaq: IDXX) is the global leader in veterinary diagnostics, supplying in-clinic analysers, consumables, reference-laboratory testing and practice-management software to companion-animal vets, plus water-microbiology and livestock/poultry/dairy testing. The company runs a razor-and-blade model with deep recurring revenue and an estimated 60–65% share of North American in-clinic diagnostics. FY2025 revenue was $4.30 billion (+10%) with GAAP EPS up 23% to $13.08. The shares have pulled back meaningfully from a 52-week high near $770 to the mid-$500s, leaving a high-quality compounder trading at a premium but more reasonable multiple. This report uses only primary-source company filings.

1. Company Snapshot

Field	Value
Company	IDEXX Laboratories, Inc.
Ticker	IDXX (Nasdaq)
Sector	Healthcare — Veterinary Diagnostics
CEO	Michael Erickson (President & CEO since 12 May 2026; Jay Mazelsky is Executive Chair)
Headquarters	Westbrook, Maine, USA
Employees	~11,000
Market cap	~$43.1bn (June 2026)
Revenue (FY2025)	$4,303.7M ($4.30bn)
Net income (FY2025)	$1,059.5M
GAAP diluted EPS (FY2025)	$13.08
Dividend	None (no dividend; capital returned via buybacks)

2. Bull / Bear Case

Bull Case

• Dominant, durable franchise: ~60–65% share of North American in-clinic diagnostics with a large, growing installed base of premium analysers driving recurring consumable revenue.
• Recurring, high-margin revenue: CAG Diagnostics recurring revenue is the engine, supporting gross margins above 60% and consistent double-digit EPS growth.
• Innovation cycle: the IDEXX inVue Dx cellular analyser and IDEXX Cancer Dx (lymphoma plus new canine mast cell tumour testing) extend the menu into high-value oncology and cytology.
• Strong cash generation: FY2025 operating cash flow of $1.18bn and ~$1.06bn free cash flow fund buybacks and reinvestment without a dividend drag.

Bear Case

• Premium valuation: even after the pull-back the stock trades around 42x trailing earnings and ~29x EV/EBITDA, leaving little room for disappointment.
• Soft vet-visit volumes: US clinical visit volumes have been pressured, making organic growth more reliant on price and new instruments than on underlying traffic.
• Intensifying competition: Mars (Antech, Heska/Element) and Zoetis (Vetscan) are building integrated, sometimes lower-priced diagnostics alternatives.
• Leadership transition: a new CEO took over in May 2026 amid a multi-year succession, adding execution uncertainty at the top.

3. Segment Breakdown

IDEXX reports three segments. Figures below are FY2025 segment revenue and share of the $4.30bn total; CAG (Companion Animal Group) dominates the mix.

Segment	% of revenue (FY2025)	What it is
Companion Animal Group (CAG)	~92% ($3,953M)	In-clinic analysers and consumables, reference-lab testing, rapid assays and veterinary software for companion animals.
Water	~5% ($201M)	Microbiology testing products for detecting contaminants in drinking and environmental water.
Livestock, Poultry & Dairy (LPD)	~3% ($132M)	Diagnostic tests for production animals and herd-health management.
Other	~0.4% ($17M)	Out-licensing arrangements and smaller product lines.

4. Business Model

IDEXX operates a razor-and-blade model centred on the veterinary clinic. It places premium diagnostic instruments into vet practices, then earns the majority of its revenue from the recurring consumables, test cartridges, reference-laboratory services and software subscriptions those instruments and practices consume every day.

How it makes money: the company's most important metric is CAG Diagnostics recurring revenue — the steady stream of consumables and lab tests tied to the installed base. New instrument placements (a record was set in Q4 2025) seed future recurring revenue, while software and rapid assays deepen the relationship with each clinic.

Unit economics and moat: the moat comes from a vast captive installed base, proprietary test menus, an integrated reference-lab network, switching costs created by software and workflow integration, and scale in R&D. These let IDEXX sustain 60%+ gross margins, ~31% operating margins and pricing power, reinvesting cash flow into new diagnostics and buybacks rather than a dividend.

5. Financial Health

The annual table covers FY2021–FY2025; the quarterly table shows the most recent five quarters, most recent first. IDEXX reports a single GAAP diluted EPS and guides on a "comparable" growth basis only, so the Adjusted EPS column mirrors GAAP EPS.

Fiscal Year	Revenue ($M)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Total debt (YE, $M)
2021	$3,215M	—	$8.60	$8.60	$0.00	—
2022	$3,367M	+4.7%	$8.03	$8.03	$0.00	—
2023	$3,661M	+8.7%	$9.90	$9.90	$0.00	$698M
2024	$3,898M	+6.5%	$10.67	$10.67	$0.00	$618M
2025	$4,304M	+10.4%	$13.08	$13.08	$0.00	$450M

Total debt shown is year-end current plus long-term debt per the consolidated balance sheet. IDEXX pays no dividend; FY2025 EPS growth included roughly a 7-point benefit from comparison with the prior year's discrete litigation accrual.

Quarter	Revenue ($M)	Adjusted EPS	GAAP EPS
Q1 2026	$1,140.8M	$3.47	$3.47
Q4 2025	$1,091M	$3.08	$3.08
Q3 2025	$1,105M	$3.40	$3.40
Q2 2025	$1,109M	$3.63	$3.63
Q1 2025	$999M	$2.97	$2.97
FY2025 total	$4,304M	$13.08	$13.08

FY2025 operating cash flow was $1,181.8M and free cash flow ~$1,057M (operating CF less capex of $124.7M). The company carries modest leverage, ending FY2025 with total debt of ~$450M against $180M of cash. See Live Charts for current price action.

6. Valuation

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

Metric	Value
Market cap	~$43.1bn (≈78.9M shares × ~$545.73, 22 Jun 2026)
Enterprise value	~$43.3bn (market cap $43.1bn + total debt $0.45bn − cash $0.18bn, per FY2025 balance sheet 31 Dec 2025)
Trailing P/E (GAAP)	~41.7x (price $545.73 / FY2025 GAAP diluted EPS $13.08)
P/E (forward)	~37.2x (price $545.73 / FY2026 EPS guidance midpoint $14.68)
P/S (TTM)	~9.7x (market cap $43.1bn / TTM revenue $4.45bn)
EV/EBITDA (TTM)	~28.9x (EV $43.3bn / FY2025 EBITDA ~$1.50bn; EBITDA = operating income $1,360M + D&A ~$140M)
P/FCF	~40.7x (market cap $43.1bn / FY2025 FCF $1.06bn; FCF = operating CF $1,181.8M − capex $124.7M)
52-week high	$769.98
52-week low	$506.91
Short interest (% of float)	Low single-digit; not separately reported this settlement — verify at Nasdaq / Finviz
Days to cover	n/a — see Nasdaq short-interest page

7. What They're Building

IDEXX's innovation agenda is anchored on expanding its diagnostic menu and instrument platform. The IDEXX inVue Dx cellular analyser saw record placements in late 2025, with FNA (fine-needle aspirate) cytology added in Q4 2025 and broad availability expanding through 2026. The IDEXX Cancer Dx panel, which launched for canine lymphoma, is being extended to canine mast cell tumour detection from mid-2026 in North America — together addressing more than one-third of canine cancer cases. The company continues to invest in reference-laboratory capabilities, rapid assays, AI-enabled diagnostic interpretation and veterinary software, reinforcing the recurring-revenue flywheel that links new instruments to long-tail consumable and lab demand.

8. Competitive Landscape

IDEXX is the clear leader in veterinary diagnostics, but faces well-capitalised integrated rivals. Mars Petcare (Antech reference labs, plus Heska/Element analysers acquired in 2023) and Zoetis (Vetscan point-of-care) are the most direct competitors, with Thermo Fisher and bioMérieux active in broader diagnostics.

Peer	Market cap (Jun 2026)	Key 2025 metric
Zoetis (ZTS)	~$49.6bn	Animal-health leader; Vetscan point-of-care diagnostics is the closest public-company rival
Thermo Fisher Scientific (TMO)	~$184bn	Broad diagnostics & life-sciences; lab instruments and reagents
Antech Diagnostics (Mars, private)	n/a — private	Largest US reference-lab competitor via VCA network and Heska/Element analysers

9. Leadership & Ownership

IDEXX is led by President & CEO Michael Erickson, who took the role on 12 May 2026; long-serving CEO Jay Mazelsky moved to Executive Chair and intends to retire after the May 2027 annual meeting. There has been no material open-market insider buying or selling in 2026 — activity has been limited to routine equity-compensation grants and vesting.

Name	Date	Type	Shares	Price	Value	Plan Type
Lawrence D. Kingsley (Director)	07 May 2026	RSU vesting	339	—	—	Comp award
Karen Peacock (Director)	2026	DSU / option grant	234 DSUs / 525 opt	—	—	Comp award
Michael Erickson (then EVP, now CEO)	12 Feb 2026	Option grant	13,667 options	—	—	Comp award

10. Key Risks

• Premium valuation (Financial): at ~42x earnings the shares price in continued execution; multiple compression is the largest downside risk.
• Soft vet-visit volumes (Macro): pressured US clinical visit traffic makes growth more dependent on price and new instruments.
• Competitive intensity (Operational): Mars/Antech and Zoetis offer integrated, sometimes cheaper diagnostics alternatives.
• New-instrument adoption (Operational): returns depend on continued inVue Dx and Cancer Dx placement and utilisation ramps.
• FX exposure (Macro): international revenue exposes results to currency swings.
• Leadership transition (Operational): a new CEO from May 2026 introduces execution and strategy-continuity risk.

11. Recent Developments

• 29 Apr 2026 — Q1 FY2026 results beat; guidance raised. Revenue rose 14.3% to $1.14bn and management lifted FY2026 EPS guidance to $14.45–14.90.
• 12 May 2026 — CEO transition. Michael Erickson became President & CEO; Jay Mazelsky transitioned to Executive Chair.
• 02 Feb 2026 — Q4 & FY2025 results. FY revenue $4.30bn (+10%) and GAAP EPS $13.08 (+23%); 2026 guidance introduced.
• 15 Jan 2026 — Cancer Dx expansion. Canine mast cell tumour testing added to the Cancer Dx panel, rolling out mid-2026 in North America.
• Q4 2025 — Record inVue Dx placements. Over 1,900 placements in the quarter and the launch of FNA cytology on the inVue Dx analyser.

12. Key Dates

• Expected Aug 2026 — Q2 FY2026 earnings (early August, per prior-year pattern)
• Expected Nov 2026 — Q3 FY2026 earnings
• Expected Feb 2027 — Q4 & full-year 2026 results

Track macro catalysts on the Economic Calendar and discuss this name in the 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: 21 June 2026

DexCom is a pure-play leader in continuous glucose monitoring (CGM), the wearable biosensor technology that has transformed diabetes care and is now expanding into the much larger market of people not on insulin. The company pairs strong double-digit revenue growth with rapidly improving profitability, and in 2025 it crossed $4.6bn of revenue while launching its 15-day G7 sensor and previewing a next-generation G8 platform. This report examines DexCom's financials, valuation, competitive position and risks using only primary-source filings and company press releases. For live pricing see our Live Charts, scheduled catalysts on the Economic Calendar, and discussion in the Forum.

1. Company Snapshot

Field	Value
Company	DexCom, Inc.
Ticker / Exchange	DXCM (Nasdaq)
Sector	Healthcare — Medical Devices
Market cap	~$28bn (June 2026)
Share price	~$72 (19 June 2026)
Revenue (FY2025)	$4.66bn
Net income (FY2025)	$836m
GAAP EPS (FY2025)	$2.09
Non-GAAP EPS (FY2025)	$2.09
Dividend	None — DexCom pays no dividend
Employees	~10,000+ (global)
CEO	Jake Leach (President & CEO since 1 January 2026)
Headquarters	San Diego, California, USA
Next earnings	Q2 2026 — expected late July 2026

2. Bull & Bear Case

Bull Case

• Durable double-digit growth: revenue grew 16% to $4.662bn in 2025 and management guides 11–13% growth in 2026 ($5.16–$5.25bn), underpinned by a large, expanding diabetes and pre-diabetes population.
• Margins inflecting upward: GAAP operating margin rose to 19.6% in 2025 from ~15%, with Q1 2026 hitting 21.4%; non-GAAP operating margin is guided to 23–23.5% for 2026.
• Product cadence and TAM expansion: the G7 15-day sensor, the over-the-counter Stelo platform for non-insulin users, and the previewed G8 widen both accuracy leadership and addressable market.
• Strong balance sheet: ~$2.4bn of cash and marketable securities against ~$1.24bn of convertible notes gives net cash and ample capacity to fund manufacturing expansion.
• Highly cash-generative: FY2025 free cash flow of roughly $1bn supports continued reinvestment without external financing.

Bear Case

• Formidable competition from Abbott: Abbott's FreeStyle Libre franchise is larger by revenue (~$5.3bn in 2024) and competes hard on price and extended wear, pressuring share and pricing.
• Premium valuation: a ~34x trailing GAAP P/E and high-20s price-to-free-cash-flow leave little margin for error if growth decelerates.
• Reimbursement and pricing risk: CGM economics depend on payer coverage and pharmacy channel pricing, which can compress as volumes scale and competition intensifies.
• One-off boost to 2025 earnings: FY2025 GAAP net income was flattered by a ~$78m gain on equity investments, overstating the underlying earnings run-rate.
• New leadership and crowded field: a CEO transition (Jake Leach from 1 January 2026) coincides with new entrants (Senseonics implantables, Biolinq microneedles, Medtronic interoperability) crowding the CGM space.

3. Business Segments

DexCom operates as a single reportable segment (continuous glucose monitoring). The table below disaggregates FY2025 revenue by geography, which is how the company reports its sales mix.

Segment	% of revenue	What it is
United States	~72%	Sales of Dexcom CGM (G7/G6, Stelo OTC) in the US, predominantly through distributors and the pharmacy channel. FY2025 revenue $3.33bn.
International	~28%	CGM sales outside the US across Europe, Asia-Pacific and other regions, via both direct and distributor channels. FY2025 revenue $1.33bn.

By channel, distributors accounted for roughly $3.96bn (about 85%) of FY2025 revenue and direct sales for about $0.70bn (about 15%).

4. Business Model

DexCom sells wearable glucose biosensors and the software that turns their data into actionable insight. The model is a razor-and-blade variant: customers adopt the system, then buy disposable sensors on a recurring basis.

How it makes money: the overwhelming majority of revenue is recurring sensor sales. A sensor is worn for up to 10–15 days and then replaced, so an installed base of users generates predictable, repeat demand. Revenue flows mainly through distributors and pharmacies, with a growing direct channel for the OTC Stelo product.

Unit economics: gross margins are high (GAAP gross margin ~62.9% in Q1 2026) and improve with manufacturing scale and automation in Arizona, Ireland and Malaysia. Because demand is recurring, customer lifetime value is large relative to acquisition cost once a patient is on the platform and reimbursed.

Moat and strategy: the moat is accuracy, clinical evidence, regulatory clearances, payer coverage and integration with insulin pumps (Tandem, Insulet, Beta Bionics). Strategy is to defend accuracy leadership with G7 15-day and G8, while expanding the addressable market into the far larger non-insulin and wellness population through Stelo.

5. Financial Health

DexCom combines rapid revenue growth with a recent step-change in profitability. The five-year record below reflects the four-for-one stock split effected in June 2022 (all per-share figures are split-adjusted). FY2025 GAAP and non-GAAP diluted EPS both landed at $2.09, with GAAP including a one-off equity-investment gain. Figures are from DexCom's annual and quarterly earnings press releases.

Fiscal Year	Revenue ($bn)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE, $m)
FY2021	2.45	—	$0.53	—	None	—
FY2022	2.91	+18.8%	$0.82	—	None	—
FY2023	3.62	+24.5%	$1.30	—	None	—
FY2024	4.03	+11.4%	$1.42	$1.64	None	1,237
FY2025	4.66	+15.6%	$2.09	$2.09	None	1,241

The most recent five quarters show steady mid-teens revenue growth and sharply higher margins. Q3 2025 GAAP EPS of $0.70 exceeded non-GAAP EPS because it included the ~$78m equity-investment gain.

Quarter	Revenue ($m)	Adjusted EPS	GAAP EPS
Q1 2026	1,191.9	$0.56	$0.51
Q4 2025	1,259.6	$0.68	$0.68
Q3 2025	1,209.0	$0.61	$0.70
Q2 2025	1,157.0	$0.48	$0.45
Q1 2025	1,036.0	$0.32	$0.27
FY2025 total	4,662.0	$2.09	$2.09

6. Valuation

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

Metric	Value
Market cap	~$28bn (June 2026)
Enterprise value	~$26.6bn (market cap ~$28bn + total debt ~$1.24bn − cash & marketable securities ~$2.42bn, per 31 Mar 2026 balance sheet)
Trailing P/E (GAAP)	~34x (price ~$72 / FY2025 GAAP EPS $2.09; note FY2025 EPS includes a ~$78m one-off equity-investment gain)
P/E (forward)	n/a — DexCom does not issue EPS guidance
P/S (TTM)	~5.8x (market cap ~$28bn / TTM revenue ~$4.82bn)
EV/EBITDA (TTM)	~23x (EV ~$26.6bn / FY2025 EBITDA ~$1.16bn; EBITDA = operating income $911.8m + D&A $251.8m; on adjusted EBITDA of $1.35bn, ~20x)
P/FCF	~27x (market cap ~$28bn / FY2025 free cash flow ~$1.04bn; FCF = operating CF ~$1.4bn − capex ~$0.36bn)
52-week high	$89.98
52-week low	$54.11
Short interest (% of float)	~2.6% (≈9.1m shares, 2026)
Days to cover	~1 day (approx., on recent average volume)

7. What Are They Building

DexCom is pushing on hardware and software simultaneously. On hardware, the headline 2026 development is the G7 15-day sensor, which extends wear time with a new algorithm, better accuracy and smoother data, and connects to Insulet and Beta Bionics pumps (with Tandem to follow). At its 2026 Investor Day the company unveiled the next-generation Dexcom G8, described as roughly half the size of the G7, with a 15-day standard wear and a sensor that self-calibrates to the user over its life.

On software and market expansion, the over-the-counter Stelo platform targets the large population of people not on insulin; a redesigned, FDA-cleared Stelo app launched in 2026 with pattern recognition, AI coaching and personalised summaries. The company also continues to build clinical evidence, presenting CONNECT randomised-trial results at the ADA 2026 Scientific Sessions in June and one-year registry data showing A1C improvement in non-insulin type 2 diabetes. Capacity expansion in Ireland and Malaysia underpins the volume ramp.

8. Competitive Landscape

DexCom competes primarily with Abbott in CGM, alongside Medtronic in integrated insulin-pump systems and a growing set of niche entrants.

Peer	Market cap (June 2026)	Key 2025 metric
Abbott Laboratories (ABT)	~$230bn	FreeStyle Libre CGM franchise ~$5.3bn revenue (2024), the largest in CGM
Medtronic (MDT)	~$115bn	~12% integrated insulin-pump share; MiniMed 780G cleared for type 2 use in 2025
Senseonics (SENS)	~$0.6bn	Eversense 365 implantable CGM; Q1 2026 revenue $11.7m, up 87% YoY

Abbott is the principal rival by scale; DexCom differentiates on accuracy, pump integrations and clinical evidence. The broader CGM market was valued at roughly $13bn in 2025 and is projected to grow at a mid-teens CAGR, leaving room for multiple players. Peer market caps are approximate as of June 2026.

9. Leadership & Ownership

Jake Leach became President and Chief Executive Officer on 1 January 2026, having previously served as chief operating officer; long-time CEO Kevin Sayer moved to an executive chair role. The leadership team is deep in CGM technology and commercial execution. No material insider open-market transactions beyond routine equity compensation and scheduled Rule 10b5-1 activity were identified in recent Form 4 filings during this review.

DexCom is broadly institutionally owned, typical of a US large-cap medical-device company, with index funds and growth managers among the largest holders. The absence of a dividend means total shareholder return depends on share-price appreciation and the company's continued reinvestment in growth.

10. Risks

• Competition (Operational): Abbott's larger Libre franchise and new entrants (Senseonics, Biolinq, Medtronic interoperability) could erode share and pricing.
• Valuation (Financial): a premium multiple means any growth or margin disappointment could trigger an outsized share-price reaction.
• Reimbursement (Regulatory): changes to payer coverage, pharmacy pricing or government reimbursement policy could compress revenue and margins.
• Regulatory & clinical (Regulatory): new products such as G8 and Stesto features depend on timely FDA clearances; delays or label limitations would slow growth.
• Concentration (Operational): revenue is concentrated in CGM and flows heavily through a small number of large distributors, creating channel and product-concentration risk.
• Manufacturing & supply (Operational): rapid capacity expansion in multiple countries carries execution, quality and supply-chain risk that could affect availability or cost.

11. Recent Developments

• 30 Apr 2026 — Q1 2026 results. Revenue grew 15% to $1.192bn, GAAP operating margin reached 21.4%, GAAP EPS $0.51 and non-GAAP EPS $0.56; full-year operating-margin and adjusted-EBITDA-margin guidance were raised.
• 12 Feb 2026 — FY2025 results. Full-year revenue grew 16% to $4.662bn with GAAP operating income of $911.8m (19.6% margin) and GAAP EPS of $2.09.
• 06 Jun 2026 — CONNECT trial at ADA 2026. DexCom presented randomised controlled trial data at the American Diabetes Association Scientific Sessions supporting CGM benefits.
• 01 Jan 2026 — CEO transition. Jake Leach became President and CEO, with Kevin Sayer moving to executive chair.

12. Key Dates

• Expected 30 Jul 2026 — Q2 2026 earnings release (date to be confirmed)
• Expected H2 2026 — continued G7 15-day rollout and Dexcom G8 development milestones
• Expected Feb 2027 — Q4 and full-year 2026 results

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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: 17 Oct 2026

Bristol Myers Squibb (NYSE: BMY) is a US biopharmaceutical company focused on oncology, haematology, immunology, cardiovascular disease and neuroscience. It reports a “Growth Portfolio” of newer medicines (Opdivo, Reblozyl, Breyanzi, Camzyos, Cobenfy and others) and a “Legacy Portfolio” led by Eliquis, Revlimid and Pomalyst. The 2026 story is a strong year that has prompted a sharp guidance raise, set against a looming wall of losses of exclusivity for Eliquis and Opdivo in 2028 and a run of mixed pipeline readouts. This refreshed report covers results through Q2 2026, the balance sheet at 30 Jun 2026, valuation and risks, using company releases and SEC filings only.

1. Company Snapshot

Field	Value
Ticker / Exchange	BMY / NYSE
Headquarters	Princeton, New Jersey, USA
CEO / Leadership	Christopher Boerner, Ph.D., Board Chair & CEO; David V. Elkins, EVP & CFO
Sector	Healthcare — biopharmaceuticals
Employees	~32,500 in 43 countries at 31 Dec 2025 (FY2025 10-K)
Market cap	~$122.1bn ($59.75 at 16 Oct 2026 close × ~2.043bn shares at 22 Jul 2026)
FY2025 Revenue	$48,194m (−0.2%)
FY2025 GAAP net income	$7,054m ($3.46 per diluted share)
FY2025 non-GAAP EPS	$6.15
2026 guidance	Revenue ~$49.0–$50.0bn and non-GAAP EPS $6.75–$7.00 (both raised on 30 Jul 2026 from ~$46.0–$47.5bn and $6.05–$6.35)
Dividend	$0.63 per quarter ($2.52 annualised; yield ~4.2%)

2. Bull & Bear Case

Bull Case

• Growth Portfolio carrying the business: Growth Portfolio revenue rose 15% to $7,560m in Q2 2026, about 58% of the total, with Breyanzi +41%, Camzyos +60% and Reblozyl +29%.
• Big 2026 guidance raise: On 30 Jul 2026 BMS lifted revenue guidance to ~$49.0–$50.0bn and non-GAAP EPS to $6.75–$7.00, helped by Eliquis growth now guided at 20–25%.
• Haematology pipeline delivering: The FDA approved ZENBEXUS (iberdomide) on 13 Aug 2026, and the Phase 3 EXCALIBER-RRMM trial showed median PFS of 42 months against 20 months (hazard ratio 0.49).
• New Phase 3 wins: In Oct 2026, RYZ101 met its PFS endpoint in the ACTION-1 neuroendocrine-tumour trial and admilparant met its primary endpoint at 60mg in ALOFT-IPF.
• Strong cash cover: Trailing-twelve-month free cash flow was about $11.4bn against an annual dividend bill of about $5.1bn, and net debt was about $31.7bn at 30 Jun 2026.

Bear Case

• Exclusivity cliff: Revlimid sales fell 49% and Pomalyst 71% in Q2 2026. Eliquis loses EU protection in Nov 2026 and US exclusivity in 2028, Opdivo’s US exclusivity ends in 2028, and management has flagged a $1.5–$2bn Eliquis step-down in 2027.
• Pipeline setbacks: Milvexian failed in Librexia ACS, Cobenfy’s ARISE adjunctive trial failed in 2025, autoimmune CAR-T enrolment was paused in Sep 2026, and the 120mg admilparant dose missed.
• Price controls: Eliquis has carried a Medicare negotiated price since 01 Jan 2026, Pomalyst follows in 2027 and Orencia in 2028, on top of Medicaid most-favoured-nation pricing.
• Celgene CVR suit revived: On 13 Aug 2026 the 2nd Circuit revived UMB Bank’s lawsuit over the Celgene contingent value rights, a claim of about $6.4bn.
• Slow Cobenfy ramp: Cobenfy generated only $63m in Q2 2026, and its Alzheimer’s psychosis readouts are not due until 2027.

3. Business Segments

BMS operates in a single segment and splits revenue into a Growth Portfolio and a Legacy Portfolio. Percentages use FY2025 revenue of $48,194m from the Q4 2025 earnings release. In FY2025 the Growth Portfolio rose 17% to $26,409m and the Legacy Portfolio fell 15% to $21,785m.

Segment / category	% of revenue	What it is
Growth — Opdivo	20.9% ($10,049m)	PD-1 immuno-oncology antibody across lung, melanoma, kidney, bladder and other cancers, now including the subcutaneous Opdivo Qvantig.
Growth — other brands	33.9% ($16,360m)	Orencia ($3,705m), Yervoy ($2,900m), Reblozyl ($2,327m), Breyanzi ($1,358m), Opdualag ($1,185m), Camzyos ($1,068m), plus Sotyktu, Krazati, Cobenfy and others.
Legacy — Eliquis	30.0% ($14,443m)	Oral anticoagulant co-marketed with Pfizer; BMS records the product revenue.
Legacy — Revlimid	6.1% ($2,951m)	Multiple myeloma drug facing full US generic competition since 31 Jan 2026.
Legacy — Pomalyst	5.7% ($2,733m)	Multiple myeloma drug that lost US exclusivity in Q1 2026.
Legacy — other	3.4% ($1,658m)	Remaining established brands in the Legacy Portfolio (derived from disclosed totals).

4. Business Model & Moat

How it makes money. BMS develops, licenses and acquires patented medicines and sells them to wholesalers, hospitals, specialty pharmacies and governments; the US accounted for $33,279m (69%) of FY2025 revenue. GAAP gross margin was 71.3% in Q2 2026, and the cash funds R&D, acquisitions and a dividend paid for 94 consecutive years.

Buying the next portfolio. BMS has relied on deals to replace its blockbusters: Celgene in 2019, then Mirati (Krazati), Karuna (Cobenfy) and RayzeBio (actinium radioligands) in 2024, the BioNTech pumitamig partnership and the May 2026 Hengrui licence. It is running a ~$2.0bn annual cost-savings programme due by end-2027 to fund the pipeline.

Moat. Patents and regulatory exclusivity, deep haematology and cell-therapy manufacturing know-how (Breyanzi, arlo-cel) and established oncology relationships protect each franchise until its exclusivity ends. The moat is product by product, so the company’s value depends on refilling the pipeline before Eliquis and Opdivo exclusivity expires in 2028.

5. Financial Health

Annual figures are from BMS’s Q4 earnings releases and SEC XBRL filings. Long-term debt is the non-current balance-sheet amount at year end.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$46,385m	+9.1%	$3.12	$7.51†	$2.01	$39,605m
FY2022	$46,159m	−0.5%	$2.95	$7.70	$2.19	$35,056m
FY2023	$45,006m	−2.5%	$3.86	$7.51	$2.31	$36,653m
FY2024	$48,300m	+7.3%	−$4.41	$1.15	$2.42	$47,603m
FY2025	$48,194m	−0.2%	$3.46	$6.15	$2.49	$42,850m

Adjusted EPS is BMS’s non-GAAP EPS as reported in each Q4 release. † FY2021 as originally reported; from 2022 BMS stopped excluding acquired IPR&D, and FY2021 was restated to $7.16. FY2024 GAAP and non-GAAP EPS include a −$6.39 per share acquired IPR&D charge, mainly for Karuna. Dividends are declared per share (SEC XBRL). The FY2024 debt step-up funded the Karuna, RayzeBio and Mirati deals.

Quarterly progression, most recent first, with the FY2025 total in bold:

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026	$12,973m	$2.04	$1.62
Q1 2026	$11,489m	$1.58	$1.31
Q4 2025	$12,502m	$1.26	$0.53
Q3 2025	$12,222m	$1.63	$1.08
FY2025 total	$48,194m	$6.15	$3.46

Acquired IPR&D cut EPS by $0.20 in Q3 2025, $0.60 in Q4 2025 and $0.03 in Q1 2026. Over the four quarters to 30 Jun 2026, revenue was about $49,186m, GAAP EPS about $4.54 and non-GAAP EPS about $6.51.

Cash flow and balance sheet. All figures are from SEC XBRL filings (FY2025 10-K and Q2 2026 10-Q).

• Operating cash flow: $14.16bn in FY2025; ~$12.78bn trailing twelve months to 30 Jun 2026.
• Capital expenditure: $1.31bn in FY2025; ~$1.34bn trailing twelve months.
• Depreciation & amortisation: $4.12bn in FY2025 (depreciation $0.62bn plus intangible amortisation $3.50bn; the narrower cash-flow add-back was $4.01bn); ~$3.31bn trailing twelve months. Amortisation fell from $9.0bn in FY2024 as Celgene-era intangibles ran off.
• Debt at 30 Jun 2026: non-current long-term debt $42,093m and short-term borrowings including current maturities $1,027m, about $43.1bn in total.
• Cash at 30 Jun 2026: cash and equivalents $8,722m plus current marketable debt securities $2,345m. Stockholders’ equity was $22,319m.

6. Valuation

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

Metric	Value
Market cap	~$122.1bn (price $59.75 at 16 Oct 2026 close × ~2.043bn shares)
Enterprise value	~$154.1bn (market cap ~$122.1bn + total debt ~$43.1bn − cash and current marketable securities ~$11.1bn per 30 Jun 2026 balance sheet; total debt = long-term debt $42.09bn + short-term borrowings $1.03bn)
Trailing P/E (GAAP)	~13.2x ($59.75 / ~$4.54 TTM GAAP EPS, Q3 2025–Q2 2026); on TTM non-GAAP EPS of ~$6.51 the multiple is ~9.2x
P/E (forward)	~8.7x ($59.75 / $6.875, the midpoint of 2026 non-GAAP EPS guidance of $6.75–$7.00)
P/S (TTM)	~2.5x ($122.1bn / ~$49.19bn TTM revenue)
EV/EBITDA (TTM)	~9.4x (EV ~$154.1bn / EBITDA ~$16.44bn; BMS reports no operating-income line, so EBITDA = TTM pre-tax income $11.91bn + interest expense $1.73bn − interest income $0.51bn + total D&A $3.31bn, using depreciation plus intangible amortisation; it is after acquired IPR&D charges)
P/FCF	~10.7x (market cap ~$122.1bn / TTM FCF ~$11.44bn; FCF = operating CF $12.78bn − capex $1.34bn); on FY2025 FCF of ~$12.85bn ($14.16bn − $1.31bn) it is ~9.5x
Price/book	~5.5x ($122.1bn / stockholders’ equity $22.3bn at 30 Jun 2026)
Dividend yield	~4.2% ($2.52 annualised / $59.75)
52-week high	$68.64 (Aug 2026)
52-week low	$42.52 (Oct 2025)
Short interest (% of float)	~2.3% (~45.8m shares short at 30 Sep 2026 settlement, Yahoo Finance data; MarketBeat showed 2.16% at 31 Aug 2026)
Days to cover	~4.0 days

7. What Are They Building

BMS is trying to build enough new revenue before 2028 to offset the loss of Eliquis and Opdivo exclusivity.

• Myeloma franchise: ZENBEXUS (iberdomide) won accelerated approval on 13 Aug 2026, and full EXCALIBER-RRMM data come at ASH in Dec 2026. Mezigdomide has a PDUFA date of 13 May 2027, and arlo-cel (GPRC5D CAR-T) hit its registrational Phase 2 endpoint, with a filing planned.
• Radiopharmaceuticals: RYZ101, an actinium-225 radioligand from RayzeBio, met its PFS endpoint at an interim analysis of ACTION-1 in neuroendocrine tumours after prior Lu-177 therapy, and BMS is discussing next steps with the FDA.
• Neuroscience: The Cobenfy ADEPT programme in Alzheimer’s disease psychosis reads out through 2027, with possible ADEPT-1 interim and ADEPT-3 data later in 2026.
• Cardiovascular: Milvexian’s Librexia AF readout has moved to Q1 2027 and Librexia STROKE to 2027, after Librexia ACS failed. Camzyos won a paediatric label expansion on 30 Sep 2026.
• Fibrosis and immunology: Admilparant met its ALOFT-IPF primary endpoint at 60mg, with ALOFT-PPF data due in early 2027. Sotyktu lupus trials are nearing primary completion, and Reblozyl in myelofibrosis anaemia has a PDUFA date of 11 Mar 2027.
• Next-generation oncology: Pumitamig (BNT327, a PD-L1xVEGF bispecific with BioNTech) is in a Phase 3 portion against pembrolizumab in lung cancer, and iza-bren posted positive Phase 3 interim data in China in TNBC and oesophageal cancer.

8. Competitive Landscape

BMS competes with the other global large-cap pharmaceutical groups across oncology, haematology, immunology and cardiovascular medicine. Market caps are mid-Oct 2026 figures. Metrics come from each company’s FY2025 results release.

Peer	Market cap (Oct 2026)	Key 2025 metric
Johnson & Johnson (JNJ)	~$616bn	FY2025 sales ~$94.2bn, +6.0%, per J&J Q4 2025 release
AbbVie (ABBV)	~$504bn	FY2025 net revenues $61,160m, +8.6%, per AbbVie Q4 2025 release
Merck & Co. (MRK)	~$360bn	FY2025 sales ~$65.0bn, +1%, per Merck Q4 2025 release
AstraZeneca (AZN)	~$257bn	FY2025 total revenue $58,739m, +8% at constant exchange rates, per AstraZeneca FY2025 results
Amgen (AMGN)	~$234bn	FY2025 revenue ~$36.8bn, +10%, per Amgen Q4 2025 release
Gilead Sciences (GILD)	~$194bn	FY2025 revenue ~$29.4bn, +2%, per Gilead Q4 2025 release
Pfizer (PFE)	~$169bn	FY2025 revenue $62,579m, −2%, per Pfizer Q4 2025 release

9. Leadership & Insider Activity

Christopher Boerner, Ph.D., is Board Chair and CEO, and David V. Elkins is EVP and CFO. Cristian Massacesi leads development as Chief Medical Officer, and Adam Lenkowsky is Chief Commercialization Officer. No leadership changes were found for Aug–Oct 2026. In 2026, Form 4 filings show three open-market sales by officers and no insider purchases. Other filings were director deferred-share awards (02 Oct 2026) and tax withholding on vesting.

Name	Date	Type	Shares	Price	Value	Plan Type
Cristian Massacesi (EVP, Chief Medical Officer)	09 Sep 2026	Sale	6,249	$64.57	~$0.40m	Open market; no 10b5-1 footnote
Phil Holzer (SVP, Controller)	25 Aug 2026	Sale	500	$67.50	~$0.03m	Open market; not under 10b5-1
David V. Elkins (EVP & CFO)	01 Apr 2026	Sale	30,000	~$61.67 (weighted)	~$1.85m	Rule 10b5-1 plan adopted 03 Jun 2025

10. Key Risks

• Loss of exclusivity (Commercial): Revlimid and Pomalyst face full US generic competition in 2026. Eliquis loses EU composition-of-matter and SPC protection in Nov 2026 and faces Japan generics in 2026 and US generics in 2028. Opdivo exclusivity ends in the US in 2028, the EU in 2030 and Japan in 2031, and Yervoy loses EU exclusivity in 2026.
• US drug pricing (Regulatory): IRA maximum fair prices apply to Eliquis from 2026 and Pomalyst from 01 Jan 2027, and Orencia was selected for 2028. Medicaid most-favoured-nation pricing, free Eliquis for Medicaid and direct sales via TrumpRx add further pressure.
• Pipeline execution (Operational): Librexia ACS failed, the Librexia AF readout has slipped to Q1 2027, and autoimmune CAR-T enrolment is paused after inflammatory events. The late-decade outlook depends on milvexian, Cobenfy in Alzheimer’s psychosis and the myeloma assets.
• Litigation (Legal): The Celgene CVR lawsuit, revived by the 2nd Circuit on 13 Aug 2026, seeks about $6.4bn over the delayed approval of a Celgene-era drug.
• Leverage (Financial): About $43.1bn of total debt at 30 Jun 2026 after the 2024 acquisition spree, with TTM interest expense of about $1.73bn. Deleveraging competes with dividends and business development.
• Eliquis 2027 step-down (Commercial): Management has guided to a $1.5–$2bn fall in Eliquis revenue in 2027, after a 2026 that was boosted by unusually strong Eliquis growth.

11. Recent Developments

• 12 Oct 2026 — ALOFT-IPF meets primary endpoint. Admilparant 60mg slowed lung-function decline (FVC at week 52) in idiopathic pulmonary fibrosis; the 120mg dose did not reach significance.
• 12 Oct 2026 — RYZ101 hits PFS in ACTION-1. The actinium-225 radioligand met its PFS endpoint at an interim analysis in gastroenteropancreatic neuroendocrine tumours after Lu-177 therapy. The shares jumped about 6.5% before the open but closed about 2.6% lower.
• 08 Oct 2026 — EXCALIBER-RRMM PFS. Iberdomide regimen median PFS was 42 months against 20 months (hazard ratio 0.49); full data come at ASH.
• 30 Sep 2026 — Camzyos paediatric approval. The FDA expanded Camzyos to paediatric obstructive HCM patients weighing at least 30kg, on the PDUFA date.
• 18 Sep 2026 — Q3 date set. BMS will report Q3 2026 results on 29 Oct 2026, with a call at 8:00am ET.
• 16 Sep 2026 — Dividend declared. The board declared $0.63 per share, payable 02 Nov 2026 to holders of record on 02 Oct 2026.
• 08 Sep 2026 — Arlo-cel registrational win. The QUINTESSENTIAL Phase 2 study of the GPRC5D CAR-T met its overall-response primary endpoint; the shares fell 3.2% that day.
• 02 Sep 2026 — Autoimmune CAR-T enrolment paused. BMS paused new enrolment in zola-cel autoimmune trials after transient, reversible inflammatory events, with no deaths reported.
• 29 Aug 2026 — Librexia ACS fails. Full data at ESC showed milvexian did not reduce cardiovascular events after acute coronary syndrome (5.4% against 5.1%).
• 13 Aug 2026 — ZENBEXUS approved; CVR suit revived. The FDA granted accelerated approval to iberdomide with daratumumab and dexamethasone in relapsed myeloma. The 2nd Circuit revived the Celgene CVR lawsuit.
• 30 Jul 2026 — Q2 2026 results. Revenue was $12,973m (+6%), GAAP EPS $1.62 and non-GAAP EPS $2.04 (+40%), and full-year revenue and EPS guidance was raised.

12. Key Dates

• 23 Oct 2026 — ESMO 2026 opens in Madrid (to 27 Oct)
• 29 Oct 2026 — Q3 2026 results and conference call (8:00am ET)
• 02 Nov 2026 — payment date for the $0.63 quarterly dividend
• Expected Nov 2026 — Eliquis EU composition-of-matter patents and SPCs expire
• 12 Dec 2026 — ASH annual meeting opens in New Orleans (to 15 Dec), with full EXCALIBER-RRMM data
• 01 Jan 2027 — Medicare negotiated price for Pomalyst takes effect
• Expected Q1 2027 — Librexia AF readout for milvexian
• 11 Mar 2027 — FDA PDUFA date for Reblozyl in myelofibrosis-associated anaemia
• 13 May 2027 — FDA PDUFA date for mezigdomide in relapsed/refractory multiple myeloma

BMS has usually declared its dividend increase in December; no date has been announced. The date for Q4 2026 results and 2027 guidance has not been announced.

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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: 18 Oct 2026

Moderna (NASDAQ: MRNA) is a US biotechnology company that develops messenger RNA (mRNA) medicines. Its revenue still comes almost entirely from COVID-19 vaccines (Spikevax and mNEXSPIKE), alongside the RSV vaccine mRESVIA. Revenue has fallen every year since the 2022 pandemic peak, and losses remain heavy. In 2026, however, Moderna won US approval for the first mRNA flu vaccine (mFLUSIVA), and its personalised cancer therapy with Merck met its Phase 3 primary endpoint in melanoma. The shares rose roughly sevenfold over twelve months. This refreshed report covers results through Q2 2026, the balance sheet at 30 Jun 2026, valuation and risks, using company releases and SEC filings only.

1. Company Snapshot

Field	Value
Ticker / Exchange	MRNA / NASDAQ (Nasdaq-100 member since 09 Oct 2026)
Headquarters	Cambridge, Massachusetts, USA
CEO / Leadership	Stéphane Bancel, CEO; Stephen Hoge, President; James (Jamey) Mock, CFO; Juan Andres, COO (from 05 Oct 2026)
Sector	Healthcare — biotechnology (mRNA vaccines and therapeutics)
Employees	~4,700 full-time in 18 countries at 31 Dec 2025 (FY2025 10-K), down from ~5,800 a year earlier
Market cap	~$87.0bn ($218.01 at 16 Oct 2026 close × ~399.2m shares at 24 Jul 2026)
FY2025 Revenue	$1,944m (−39.9%)
FY2025 GAAP net loss	−$2,822m (−$7.26 per diluted share)
2026 guidance	Revenue growth of up to 10% on 2025, split about half US and half international; year-end cash and investments $4.7–$5.2bn (set on 31 Jul 2026, before the $2.6bn convertible-note issue)
Dividend	None paid

2. Bull & Bear Case

Bull Case

• First mRNA flu vaccine approved: The FDA approved mFLUSIVA (mRNA-1010) for adults aged 50 and over in Aug 2026, Moderna’s fifth approved product globally, and the EU approved the flu/COVID combination mCOMBRIAX in Apr 2026.
• Oncology Phase 3 success: INTerpath-001, testing intismeran autogene with Merck’s KEYTRUDA in resected melanoma, met its recurrence-free survival primary endpoint and a key secondary endpoint at an interim analysis. The data are a late-breaking abstract at ESMO on 24 Oct 2026.
• Cost base coming down: Q2 2026 R&D fell 7% and SG&A 6% year on year. Cash costs are targeted at about $4.2bn in 2026 and $3.5–$3.9bn in 2027, and cash breakeven is targeted for 2028.
• Funded runway: Cash and investments were $6.9bn at 30 Jun 2026, before net proceeds of about $2.56bn from 0% convertible notes due 2032. Further draws are available on the Ares credit facility.
• Onshore manufacturing partnerships: Moderna-owned plants in the UK, Canada and Australia supply long-term government contracts, which brings stand-ready revenue and steadier international demand.

Bear Case

• Shrinking core revenue: Revenue fell from $19,263m in FY2022 to $1,944m in FY2025. Q2 2026 revenue was just $145m, and US product sales fell to $70m from $88m a year earlier.
• Heavy losses and cash burn: The FY2025 net loss was $2,822m. Over the twelve months to 30 Jun 2026, operating cash outflow was about $1.07bn and free cash flow about −$1.24bn, and Moderna paid $950m in Jul 2026 to settle with Arbutus/Genevant.
• US vaccine policy uncertainty: The 2026-27 COVID vaccines are approved only for adults aged 65 and over and higher-risk younger people, and ACIP has issued no flu or COVID recommendations for the season while litigation over its reconstitution continues.
• Valuation after a sevenfold rally: The shares rose from a 52-week low of $22.28 to $242.29, about 39x trailing sales, while senior executives sold stock under 10b5-1 plans.
• Patent litigation: GSK suits go to trial in 2027, a Bayer (Monsanto) suit was allowed to proceed on 28 Sep 2026, and the EPO revoked a key Moderna patent Moderna had asserted against Pfizer/BioNTech.

3. Business Segments

Moderna operates in a single segment. Percentages use FY2025 total revenue of $1,944m: net product sales were $1,818m and other revenue $126m. By geography, total revenue was about $1.2bn in the US and $745m internationally.

Segment / category	% of revenue	What it is
COVID-19 vaccines	93.1% ($1,810m)	Spikevax and the next-generation mNEXSPIKE, reported together, sold to governments, wholesalers, distributors and retail pharmacies.
RSV vaccine	0.4% ($8m)	mRESVIA, approved for older and at-risk adults; an EU joint-procurement contract covers up to 24m doses for six countries.
Other revenue	6.5% ($126m)	Grants, collaboration, licensing and royalty income, plus stand-ready manufacturing revenue from government partnerships.

4. Business Model & Moat

How it makes money. Moderna sells seasonal respiratory vaccines through US wholesalers, distributors and retailers and through government contracts and tenders abroad. Sales cluster in the second half of the year: 55% of 2026 second-half revenue is expected in Q3. Product gross margin swings widely, from about 79% in Q3 2025 to near zero in Q2 2026, when $93m cost of sales included $41m of inventory write-downs and $23m of unutilised capacity.

Platform economics. One mRNA platform and shared manufacturing support every product. The aim is to add flu, combination and norovirus vaccines and individualised cancer therapies to the same plant network. Since 2022 Moderna has exited eight contract manufacturers and built its own plants in Laval (Canada), Harwell (UK) and Clayton (Australia), plus Norwood and Marlborough in Massachusetts.

Moat. Moderna’s edge is a decade of mRNA design, lipid-nanoparticle and manufacturing know-how, which lets it develop new vaccines quickly. Its intellectual property is contested, though: it paid $950m to settle the Arbutus/Genevant case and faces GSK and Bayer suits, so the platform is defensible but not exclusive.

5. Financial Health

Annual figures are from Moderna’s Q4 earnings releases and SEC XBRL filings. Long-term debt is the non-current balance-sheet amount at year end.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$18,471m	+2,200.2%	$28.29	$28.29†	Nil	Nil‡
FY2022	$19,263m	+4.3%	$20.12	$20.12†	Nil	Nil‡
FY2023	$6,848m	−64.4%	−$12.33	−$12.33†	Nil	Nil‡
FY2024	$3,236m	−52.7%	−$9.28	−$9.28†	Nil	$0m
FY2025	$1,944m	−39.9%	−$7.26	−$7.26†	Nil	$590m

† Moderna reports GAAP results only and publishes no adjusted EPS, so the GAAP figure is repeated. ‡ Moderna had no borrowings before its Ares term loan of up to $1.5bn, which closed on 20 Nov 2025 with $600m drawn; FY2024 non-current long-term debt was $0m in SEC XBRL. FY2021 growth is measured against FY2020 revenue of $803m, before COVID vaccine sales began at scale. Moderna has never paid a dividend; it repurchased $3,329m of stock in 2022 and $1,153m in 2023.

Quarterly progression, most recent first, with the FY2025 total in bold:

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026	$145m	−$1.97†	−$1.97
Q1 2026	$389m	−$3.40†	−$3.40
Q4 2025	$678m	−$2.11†	−$2.11
Q3 2025	$1,016m	−$0.51†	−$0.51
FY2025 total	$1,944m	−$7.26†	−$7.26

Q1 2026 GAAP EPS includes a −$2.22 per share hit from the Arbutus/Genevant settlement, booked mainly in cost of sales ($878m). Over the four quarters to 30 Jun 2026, revenue was about $2,228m and GAAP EPS about −$7.99.

Cash flow and balance sheet. All figures are from SEC XBRL filings (FY2025 10-K and Q2 2026 10-Q).

• Operating cash flow: −$1.87bn in FY2025; ~−$1.07bn trailing twelve months to 30 Jun 2026.
• Capital expenditure: $0.19bn in FY2025; ~$0.17bn trailing twelve months, against 2026 guidance of $0.2–$0.3bn.
• Depreciation & amortisation: $0.21bn in FY2025; ~$0.23bn trailing twelve months.
• Debt at 30 Jun 2026: $591m of non-current long-term debt (the Ares term loan), with no current portion. After the quarter, Moderna issued $2.6bn of 0.00% convertible senior notes due 01 Mar 2032 (conversion price ~$210.58), priced on 28 Aug 2026.
• Cash at 30 Jun 2026: cash and equivalents $1,723m, current investments $3,415m and non-current investments $1,772m, $6.91bn in total. Moderna paid $950m to Arbutus/Genevant in Jul 2026. Stockholders’ equity was $6,761m.

6. Valuation

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

Metric	Value
Market cap	~$87.0bn (price $218.01 at 16 Oct 2026 close × ~399.2m shares)
Enterprise value	~$80.7bn (market cap ~$87.0bn + total debt ~$0.59bn − cash and investments ~$6.91bn per 30 Jun 2026 balance sheet). Adjusted for the $950m Jul 2026 settlement payment and the $2.6bn Sep 2026 convertible notes (net proceeds ~$2.56bn), it is ~$81.7bn
Trailing P/E (GAAP)	n/m — TTM GAAP EPS is ~−$7.99 (Q3 2025–Q2 2026)
P/E (forward)	n/m — Moderna gives no EPS guidance, and its cost and cash guidance implies continued losses in 2026, with cash breakeven targeted for 2028
P/S (TTM)	~39.1x ($87.0bn / ~$2.23bn TTM revenue)
EV/EBITDA (TTM)	n/m — TTM EBITDA is ~−$3.09bn (operating loss ~−$3.32bn + D&A ~$0.23bn), including the ~$0.9bn Q1 2026 settlement charge
P/FCF	n/m — TTM FCF is ~−$1.24bn (operating CF −$1.07bn − capex $0.17bn); FY2025 FCF was ~−$2.07bn (−$1.87bn − $0.19bn)
Price/book	~12.9x ($87.0bn / stockholders’ equity $6.76bn at 30 Jun 2026)
52-week high	$242.29 (15 Oct 2026, intraday)
52-week low	$22.28 (21 Nov 2025, intraday)
Short interest (% of float)	~8.7% (30.9m shares at 30 Sep 2026 settlement, MarketBeat; FINRA data show ~7.7% of shares outstanding), down from a peak of 71.5m shares on 30 Jan 2026
Days to cover	~1.8 days

7. What Are They Building

Moderna is trying to turn a single-product COVID business into a broader respiratory-vaccine and oncology company before cash breakeven in 2028. It targets up to six approved seasonal products by 2028 and up to three new launches in 2027–28.

• Seasonal respiratory vaccines: mFLUSIVA (flu) won US approval in Aug 2026, with traditional approval for ages 50–64 and accelerated approval for 65 and over. mCOMBRIAX (flu plus COVID, mRNA-1083) is approved in the EU and under review in Japan, Canada and Australia, while Moderna awaits FDA guidance on refiling in the US.
• Individualised cancer therapy: Intismeran autogene (mRNA-4157, with Merck) is in nine Phase 2/3 trials across melanoma, lung, bladder and kidney cancer. INTerpath-001 was positive in melanoma, Phase 3 work in Stage I lung cancer has started, and a dedicated plant in Marlborough, MA has been built for commercial supply.
• Norovirus: The mRNA-1403 Phase 3 did not meet the criteria for early success at its interim analysis. The trial stays blinded and Moderna is preparing to enrol an additional cohort.
• Rare disease: The registrational study of mRNA-3927 in propionic acidemia is fully enrolled, and partner Recordati expects data by the end of 2026. The pivotal-trial decision for mRNA-3705 (methylmalonic acidemia) waits on those data.
• Pruned programmes: The congenital CMV vaccine was discontinued after its Phase 3 failure, HSV and VZV vaccines will not advance to Phase 3, and several flu combination candidates are paused. Smaller programmes include pandemic flu (mRNA-1018, with CEPI) and a Bundibugyo Ebola vaccine (mRNA-1469) that entered Phase 1 on 04 Aug 2026.

8. Competitive Landscape

Moderna competes with Pfizer/BioNTech in COVID vaccines, with GSK, Sanofi, CSL Seqirus and Pfizer in flu and RSV, and with Novavax’s protein-based COVID shot. Merck is also its oncology partner. Market caps are mid-Oct 2026 figures, and metrics come from each company’s FY2025 results release.

Peer	Market cap (Oct 2026)	Key 2025 metric
Merck & Co. (MRK)	~$360bn	FY2025 worldwide sales $65.0bn, including Gardasil ~$5.2bn (−39%), per Merck Q4 2025 release
Pfizer (PFE)	~$169bn	FY2025 revenue ~$62.6bn, per Pfizer FY2025 results release
GSK (GSK)	~$99bn	FY2025 total sales £32.7bn, including vaccines £9.2bn, per GSK FY2025 results
Sanofi (SNY)	~$97bn	FY2025 Beyfortus (RSV antibody) sales ~€1.8bn, per Sanofi FY2025 results
CSL (CSL.AX), owner of Seqirus	~US$64bn	FY2025 (year to Jun 2025) group revenue ~US$15.6bn, per CSL results
BioNTech (BNTX)	~$22.7bn	FY2025 revenue €2,869.9m, per BioNTech FY2025 results release
Novavax (NVAX)	~$1.9bn	FY2025 total revenue $1,123m, per Novavax FY2025 results release

9. Leadership & Insider Activity

Stéphane Bancel is CEO and a director. Stephen Hoge is President and since 16 Jun 2026 has had operating oversight of R&D, manufacturing and commercial. James (Jamey) Mock has been CFO since Sep 2022. In 2026 David Berman became Chief Development Officer (02 Mar) and Ester Banque Chief Commercial Officer (15 Jun). Former Biogen CFO Michael McDonnell joined the board on 08 Jul. Juan Andres returned as Chief Operating Officer on 05 Oct, when Jerh Collins retired. Form 4 filings show no open-market insider purchases in 2026; the recent sales below are mostly under Rule 10b5-1 plans.

Name	Date	Type	Shares	Price	Value	Plan Type
Stephen Hoge (President)	15 Oct 2026	Option exercise and sale	39,145	$220.72	~$8.64m	Rule 10b5-1 plan adopted 15 Jun 2026
Stephen Hoge (President)	14 Oct 2026	Option exercise and sale	39,224	~$213.47–$214.15	~$8.37m	Rule 10b5-1 plan adopted 15 Jun 2026
Stephen Hoge (President)	15 Sep 2026	Sale	40,281	$146.07	~$5.88m	Rule 10b5-1 plan adopted 15 Jun 2026
Stephen Hoge (President)	14 Sep 2026	Sale	40,294	$144.13	~$5.81m	Rule 10b5-1 plan adopted 15 Jun 2026
James Mock (CFO)	10 Sep 2026	Option exercise and sale	34,836	$134.49	~$4.69m	Rule 10b5-1 plan adopted 09 Jun 2026
Shannon Thyme Klinger (General Counsel)	01 Sep 2026	Sale	3,471	$139.95	~$0.49m	Plan status not verified
Stéphane Bancel (CEO)	05 Aug 2026	Option exercise and sale	499,246	~$57.52 (weighted)	~$28.7m	Rule 10b5-1 plan adopted 04 May 2026; cashless exercise of options expiring 10 Aug 2026

10. Key Risks

• US vaccine policy (Regulatory): A Mar 2026 court order stayed the appointments and votes of the reconstituted ACIP, and the First Circuit heard the appeal on 06 Oct 2026. There is no federal flu or COVID recommendation for 2026-27, and FDA labels for the new COVID vaccines are limited to adults aged 65 and over and higher-risk younger people.
• Cash burn (Financial): Operating cash outflow was $1.16bn in H1 2026, and Moderna paid the $950m settlement in Jul 2026. Year-end cash guidance of $4.7–$5.2bn predates the convertible notes, and breakeven is not targeted until 2028.
• Leverage and dilution (Financial): Moderna now carries the $591m Ares loan plus $2.6bn of convertible notes due 2032, convertible at about $210.58 per share. The capped call offsets dilution only up to $392.62.
• Patent litigation (Legal): GSK’s Spikevax and mRESVIA suits go to trial in Delaware in Jul and Aug 2027. A Delaware judge let Bayer’s mRNA patent suit proceed on 28 Sep 2026, and in Sep 2026 the EPO revoked EP 3 590 949, the patent Moderna had asserted against Pfizer/BioNTech.
• COVID demand and concentration (Commercial): COVID vaccines were 93% of FY2025 revenue. US COVID demand keeps falling, inventory write-downs were $291m in FY2025, and mRESVIA sold only $8m that year.
• Clinical and launch execution (Operational): Much of the valuation rests on the full INTerpath-001 data, on regulators accepting intismeran, and on the mFLUSIVA launch. The norovirus vaccine already missed at its interim analysis, and the 65-and-over flu approval needs a confirmatory trial.

11. Recent Developments

• 16 Oct 2026 — Shares pull back. The stock fell 7.8% to $218.01, a day after setting a 52-week intraday high of $242.29.
• 14 Oct 2026 — President sells under plan. Stephen Hoge sold about 78,000 shares on 14–15 Oct under his Rule 10b5-1 plan, worth about $17m.
• 13 Oct 2026 — Q3 date set. Moderna will report Q3 2026 results on Friday 06 Nov 2026, with a call at 8:00am ET.
• 09 Oct 2026 — Joins the Nasdaq-100. Moderna replaced Warner Bros. Discovery in the index, as announced by Nasdaq on 01 Oct.
• 30 Sep 2026 — New COO. Juan Andres returned as Chief Operating Officer, a new role leading manufacturing, effective 05 Oct; Jerh Collins is retiring.
• 28 Sep 2026 — Bayer suit proceeds. A Delaware federal judge refused to dismiss Bayer’s mRNA-stabilisation patent suits against Moderna and Pfizer/BioNTech.
• 21 Sep 2026 — ESMO late-breaker. INTerpath-001 Phase 3 data were selected as LBA1 in the ESMO 2026 Presidential Symposium on 24 Oct.
• 28 Aug 2026 — $2.6bn convertible priced. Moderna priced upsized 0.00% convertible senior notes due 2032 at a 47.5% conversion premium, with net proceeds of about $2.56bn.
• 27 Aug 2026 — 2026-27 COVID vaccines approved. The FDA approved the updated Spikevax and mNEXSPIKE for adults aged 65 and over and for higher-risk younger people.
• 19 Aug 2026 — INTerpath-001 positive. Merck and Moderna said intismeran autogene plus KEYTRUDA met the recurrence-free survival primary endpoint and the distant-metastasis-free survival secondary endpoint at an interim analysis in 1,137 patients.
• 05 Aug 2026 — mFLUSIVA approved. The FDA approved mRNA-1010, the first mRNA flu vaccine, for adults aged 50 and over, after a unanimous VRBPAC vote in Jun.
• 31 Jul 2026 — Q2 2026 results. Revenue was $145m and GAAP EPS −$1.97, and cash and investments were $6.9bn. The norovirus Phase 3 missed the interim criteria for early success.

12. Key Dates

• 23 Oct 2026 — ESMO Congress 2026 opens in Madrid (to 27 Oct)
• 24 Oct 2026 — INTerpath-001 Phase 3 presentation (LBA1, 10:30am EDT), followed by an investor webcast at 1:00pm EDT
• 06 Nov 2026 — Q3 2026 results and conference call (8:00am ET)
• 12 Nov 2026 — Moderna Analyst Day
• Expected by end of 2026 — registrational data for mRNA-3927 in propionic acidemia (per partner Recordati)
• TBC — First Circuit ruling on the ACIP litigation (argued 06 Oct 2026)
• 19 Jul 2027 — GSK v. Moderna Spikevax patent trial begins in Delaware
• 23 Aug 2027 — GSK v. Moderna mRESVIA patent trial begins in Delaware
• 01 Mar 2032 — maturity of the $2.6bn 0.00% convertible senior notes

Regulatory decisions on mRNA-1010 in the EU, Canada and Australia and on mRNA-1083 in Japan, Canada and Australia are pending, with no dates announced. No pending US PDUFA date has been disclosed.

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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: 17 Oct 2026

AbbVie (NYSE: ABBV) is a US biopharmaceutical group whose sales are led by the immunology drugs Skyrizi and Rinvoq, a fast-growing neuroscience franchise (Vraylar, Botox Therapeutic, the migraine drugs and the newly approved Parkinson’s drug JUVMO), oncology and the Allergan aesthetics business. The 2026 story is whether Skyrizi and Rinvoq can keep more than replacing lost Humira sales while AbbVie absorbs IRA price setting, a heavier debt load after the $10.9bn Apogee deal and recurring in-process R&D charges. This refreshed report covers results through Q2 2026, the balance sheet at 30 Jun 2026, valuation and risks, using company releases and SEC filings only.

1. Company Snapshot

Field	Value
Ticker / Exchange	ABBV / NYSE
Headquarters	1 North Waukegan Road, North Chicago, Illinois, USA
CEO / Leadership	Robert A. Michael, Chairman & CEO; Scott T. Reents, EVP & CFO
Sector	Healthcare — biopharmaceuticals and medical aesthetics
Employees	~57,000 in more than 70 countries at 31 Dec 2025 (FY2025 10-K)
Market cap	~$504.4bn ($285.42 at 16 Oct 2026 close × ~1.767bn shares at 27 Jul 2026)
FY2025 Revenue	$61,160m net revenues (+8.6%)
FY2025 GAAP net income	$4,226m ($2.36 per diluted share)
FY2025 adjusted EPS	$10.00 (after a −$2.76 per share IPR&D and milestones impact)
2026 guidance	Adjusted EPS $13.76–$13.96 (lowered on 05 Oct 2026 for $216m of Q3 IPR&D; started the year at $14.37–$14.57)
Dividend	$1.73 per quarter ($6.92 annualised; yield ~2.4%)

2. Bull & Bear Case

Bull Case

• Skyrizi and Rinvoq still compounding: Q2 2026 Skyrizi sales were $5,505m (+24.4%) and Rinvoq $2,525m (+24.5%), lifting Immunology to $8,786m (+15.1%) even as Humira fell 35.9%.
• Long patent runway: US composition-of-matter patents on Skyrizi and Rinvoq run to 2033, and generic settlements mean no US Rinvoq generic before Apr 2037 (FY2025 10-K).
• Neuroscience is a second engine: Neuroscience revenue rose 20.3% to $3,228m in Q2 2026, and the FDA approved JUVMO (tavapadon) for Parkinson’s disease on 28 Sep 2026.
• Cash generation covers the dividend: Trailing-twelve-month free cash flow to 30 Jun 2026 was about $18.2bn against an annual dividend bill of about $12.2bn, and the quarterly payout was raised 5.5% to $1.73 from Feb 2026.
• Deep late-stage pipeline: Temab-A won two FDA Breakthrough Therapy Designations on 07 Oct 2026, etentamig and epcoritamab both hit Phase 3 endpoints in Sep–Oct 2026, and the Apogee deal added IL-13 antibody zumilokibart.

Bear Case

• Debt and negative equity: Total debt was about $70.8bn at 30 Jun 2026 before about $10bn of new notes issued in Aug 2026 for Apogee, and stockholders’ equity was −$5.9bn.
• Erosion and price setting: Humira (−35.9%) and Imbruvica (−29.4%) are still shrinking, Imbruvica has carried a Medicare negotiated price since 01 Jan 2026, and Vraylar, Linzess (2027) and Botox (2028) follow.
• Two-drug concentration: Skyrizi and Rinvoq made up about 47% of Q2 2026 net revenues, so any safety, competitive or pricing setback in immunology would weigh on the whole group.
• IPR&D charges keep cutting guidance: Year-to-date IPR&D reached $1,251m by 05 Oct 2026, and the 2026 adjusted EPS guidance midpoint has fallen from $14.47 in February to $13.86 as those charges were added.
• Aesthetics and oncology lagging: Aesthetics revenue fell 6.1% in FY2025 and was flat (+0.3%) in Q2 2026, while Oncology fell 1.5% in Q2 2026.

3. Business Segments

AbbVie reports one global business segment. Revenue is disclosed by therapeutic area and key product. Percentages use FY2025 net revenues of $61,160m from the Q4 2025 earnings release. From 2026 the product tables no longer show a separate Eye Care line.

Segment / category	% of revenue	What it is
Immunology	49.7% ($30,406m)	Skyrizi ($17,562m), Rinvoq ($8,304m) and Humira ($4,540m, −49.5%) for psoriasis, arthritis and inflammatory bowel disease.
Neuroscience	17.6% ($10,767m)	Vraylar, Botox Therapeutic, Ubrelvy and Qulipta for migraine, Vyalev for Parkinson’s disease.
Oncology	10.9% ($6,655m)	Venclexta, Imbruvica, Elahere, Epkinly and Emrelis in blood cancers and solid tumours.
Aesthetics	7.9% ($4,860m)	Botox Cosmetic, Juvederm fillers and other Allergan Aesthetics products.
Other key products	6.1% ($3,736m)	Mavyret (hepatitis C), Creon (pancreatic enzymes) and Linzess (gastrointestinal).
Eye Care	3.4% ($2,109m)	Alphagan, Combigan and other ophthalmic drugs; no longer shown as a separate line from 2026.
All other	4.3% (~$2,627m)	Remaining products not listed in the key-product tables (derived from disclosed totals).

4. Business Model & Moat

How it makes money. AbbVie discovers, licenses and acquires patented medicines and aesthetic products and sells them to wholesalers, pharmacies, hospitals and clinics worldwide, with the US the largest market. The adjusted gross margin was 84.7% and the adjusted operating margin 48.3% in Q2 2026, which funds R&D, business development and a dividend of $6.92 per share a year.

Replacing Humira by design. AbbVie built Skyrizi and Rinvoq to take over from Humira, which now faces US biosimilar competition. FY2025 Humira sales were $4,540m, while Skyrizi and Rinvoq together reached $25,866m. Acquisitions and licences, most recently Apogee and the Gubra amylin programme, add further growth options.

Moat. Patents and regulatory exclusivity protect pricing on each product until expiry, backed by large-scale biologics manufacturing and an established commercial presence in immunology. The Allergan aesthetics brands add a consumer-facing franchise with no patent cliff, though it is more sensitive to consumer spending.

Policy positioning. In Jan 2026 AbbVie signed a voluntary three-year pricing agreement with the US administration covering Medicaid and TrumpRx pricing. It is paired with a $100bn, 10-year US R&D and capital commitment in return for tariff relief and exemption from future pricing mandates.

5. Financial Health

Annual figures are from AbbVie’s Q4 earnings releases and SEC XBRL filings. Long-term debt is the non-current balance-sheet amount of long-term debt and finance lease obligations at year end.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$56,197m	+22.7%	$6.45	$12.70	$5.31	$64,189m
FY2022	$58,054m	+3.3%	$6.63	$13.77	$5.71	$59,135m
FY2023	$54,318m	−6.4%	$2.72	$11.11	$5.99	$52,194m
FY2024	$56,334m	+3.7%	$2.39	$10.12	$6.29	$60,340m
FY2025	$61,160m	+8.6%	$2.36	$10.00	$6.65	$58,941m

Adjusted EPS is as reported in each Q4 release. AbbVie does not exclude acquired IPR&D and milestone charges from adjusted EPS; they cut FY2025 adjusted EPS by $2.76. Dividends are declared per share (SEC XBRL).

Quarterly progression, most recent first, with the FY2025 total in bold:

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026	$16,990m	$3.65	$2.03
Q1 2026	$15,002m	$2.65	$0.39
Q4 2025	$16,618m	$2.71	$1.02
Q3 2025	$15,776m	$1.86	$0.10
FY2025 total	$61,160m	$10.00	$2.36

IPR&D and milestone charges cut adjusted EPS by $1.50 in Q3 2025, $0.71 in Q4 2025, $0.41 in Q1 2026 and $0.17 in Q2 2026. Over the four quarters to 30 Jun 2026, revenue was about $64,386m, GAAP EPS about $3.54 and adjusted EPS about $10.87.

Cash flow and balance sheet. All figures are from SEC XBRL filings (FY2025 10-K and Q2 2026 10-Q).

• Operating cash flow: $19.03bn in FY2025; ~$19.51bn trailing twelve months to 30 Jun 2026.
• Capital expenditure: $1.21bn in FY2025; ~$1.30bn trailing twelve months.
• Depreciation & amortisation: $8.14bn in FY2025 (depreciation $0.76bn plus intangible amortisation $7.38bn); ~$7.87bn trailing twelve months.
• Debt at 30 Jun 2026: non-current long-term debt and finance leases $62,481m plus current portion $8,341m, about $70.8bn in total. About $10bn of senior notes (2028–2066) followed on 18 Aug 2026 to fund Apogee.
• Cash at 30 Jun 2026: cash and equivalents $6,569m. Stockholders’ equity was −$5,935m.

6. Valuation

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

Metric	Value
Market cap	~$504.4bn (price $285.42 at 16 Oct 2026 close × ~1.767bn shares)
Enterprise value	~$568.6bn (market cap ~$504.4bn + total debt ~$70.8bn − cash ~$6.6bn per 30 Jun 2026 balance sheet; total debt = non-current $62.48bn + current $8.34bn). Including the Aug 2026 Apogee notes and the ~$10.9bn cash paid in Sep 2026, pro forma EV is roughly $579bn
Trailing P/E (GAAP)	~80.6x ($285.42 / ~$3.54 TTM GAAP EPS, Q3 2025–Q2 2026, depressed by IPR&D charges and intangible amortisation); on TTM adjusted EPS of ~$10.87 the multiple is ~26.3x
P/E (forward)	~20.6x ($285.42 / $13.86, the midpoint of 2026 adjusted EPS guidance of $13.76–$13.96)
P/S (TTM)	~7.8x ($504.4bn / ~$64.39bn TTM revenue)
EV/EBITDA (TTM)	~23.0x (EV ~$568.6bn / EBITDA ~$24.74bn; EBITDA = TTM GAAP operating income $16.87bn + total D&A $7.87bn, using depreciation plus intangible amortisation; operating income is after IPR&D and milestone charges)
P/FCF	~27.7x (market cap ~$504.4bn / TTM FCF ~$18.21bn; FCF = operating CF $19.51bn − capex $1.30bn); on FY2025 FCF of ~$17.82bn ($19.03bn − $1.21bn) it is ~28.3x
Price/book	n/m — stockholders’ equity was negative (−$5.9bn) at 30 Jun 2026
Dividend yield	~2.4% ($6.92 annualised / $285.42)
52-week high	$291.40 (intraday, 15 Oct 2026)
52-week low	$190.75
Short interest (% of float)	~1.0% (~16.3m shares short at 30 Sep 2026 settlement, Yahoo Finance data)
Days to cover	~3.9 days

7. What Are They Building

AbbVie’s pipeline aims to extend immunology beyond Skyrizi and Rinvoq, deepen neuroscience and rebuild oncology around antibody-drug conjugates and bispecifics.

• Immunology label expansion: Skyrizi subcutaneous induction in Crohn’s disease was filed in the US in Apr 2026 (decision expected later in 2026) and in the EU in Aug 2026. US filings for Rinvoq in vitiligo and alopecia areata are pending after EU approvals in Jul 2026.
• Apogee assets: Zumilokibart (APG777), a long-acting IL-13 antibody, reported positive Phase 2 APEX Part B data in atopic dermatitis on 30 Sep 2026. APG273 (IL-13/TSLP) targets asthma.
• Neuroscience: JUVMO (tavapadon) launches in the US in Oct 2026. Atogepant posted positive Phase 3 data in menstrual migraine, and a new Phase 2 of emraclidine is recruiting after the 2024 schizophrenia trials failed.
• Oncology: Temab-A (ABBV-400, a c-Met ADC) is in multiple Phase 3 studies and won Breakthrough designations in colorectal and lung cancer. Etentamig (ABBV-383) succeeded in the Phase 3 CERVINO myeloma trial, and epcoritamab plus R-CHOP met its PFS endpoint in first-line DLBCL.
• Obesity: ABBV-295, a long-acting amylin analogue licensed from Gubra, started a ~360-patient Phase 2 in Aug 2026.
• Aesthetics: The FDA accepted a Botox Cosmetic filing for masseter muscle prominence on 04 Aug 2026. TrenibotE awaits resubmission after an Apr 2026 manufacturing-only complete response letter.

8. Competitive Landscape

AbbVie competes with other global large-cap pharmaceutical groups, and directly with J&J, Lilly, Pfizer and Amgen in immunology. Market caps are mid-Oct 2026 figures. Metrics come from each company’s FY2025 results release.

Peer	Market cap (Oct 2026)	Key 2025 metric
Eli Lilly (LLY)	~$1,120bn	FY2025 revenue ~$65.2bn, +45%, per Lilly Q4 2025 release
Johnson & Johnson (JNJ)	~$610bn	FY2025 sales ~$94.2bn, +6.0%, per J&J Q4 2025 release
Merck & Co. (MRK)	~$358bn	FY2025 sales ~$65.0bn, +1%, per Merck Q4 2025 release
AstraZeneca (AZN)	~$261bn	FY2025 total revenue $58,739m, +8% at constant exchange rates, per AstraZeneca FY2025 results
Amgen (AMGN)	~$235bn	FY2025 revenue ~$36.8bn, +10%, per Amgen Q4 2025 release
Pfizer (PFE)	~$168bn	FY2025 revenue $62,579m, −2%, per Pfizer Q4 2025 release
Bristol Myers Squibb (BMY)	~$122bn	FY2025 revenue $48,194m, roughly flat, per BMS Q4 2025 release

9. Leadership & Insider Activity

Robert A. Michael is Chairman and CEO, and Scott T. Reents is EVP and CFO; no leadership changes were announced between Aug and Oct 2026. Form 4 filings in 2026 show open-market sales by three officers and no open-market purchases. Other filings were annual equity awards (18 Feb 2026), tax-withholding share dispositions on vesting (27 Feb 2026) and director stock awards.

Name	Date	Type	Shares	Price	Value	Plan Type
Nicholas Donoghoe (EVP, Chief Business & Strategy Officer)	14 Aug 2026	Sale (after option exercise)	32,710	$250.00	~$8.18m	Open market; Form 4 indicates not under 10b5-1
David Purdue (SVP, Controller)	04 Mar 2026	Sale	5,230	$233.56	~$1.22m	Open market; plan status not stated
Perry Siatis (EVP, General Counsel)	02 Mar 2026	Sale	18,668	$234.39	~$4.38m	Open market; plan status not stated
Robert A. Michael (Chairman & CEO)	27 Feb 2026	Tax withholding	36,523	$232.08	~$8.48m	Shares withheld on vesting; not an open-market sale
Perry Siatis (EVP, General Counsel)	25 Feb 2026	Sale (after option exercise)	22,381	$230.00	~$5.15m	Open market; plan status not stated

10. Key Risks

• Humira and Imbruvica erosion (Commercial): Humira sales fell 49.5% in FY2025 and 35.9% in Q2 2026, and Imbruvica fell 29.4% in Q2 2026 under its first Medicare negotiated price.
• US drug pricing (Regulatory): IRA prices apply to Imbruvica from 2026, to Vraylar and Linzess from 01 Jan 2027 and to Botox from 01 Jan 2028, and more products could be selected. The voluntary pricing agreement and the 340B Rebate Model Pilot add further price concessions.
• Leverage (Financial): Total debt of about $70.8bn at 30 Jun 2026, plus about $10bn of Apogee notes, against negative stockholders’ equity. Apogee is guided to dilute EPS by $0.14 in 2026 and $0.46 in 2027.
• Immunology concentration (Commercial): Skyrizi and Rinvoq made up about 47% of Q2 2026 revenue, so new competing immunology drugs, safety label changes or price pressure on either brand would hit the core of the business.
• IPR&D volatility (Financial): Acquired IPR&D and milestone payments are not excluded from adjusted EPS, so licensing deals repeatedly reduce guidance ($1,251m year to date by 05 Oct 2026).
• Litigation (Legal): Humira antitrust claims (trimmed on 01 Oct 2026 but not dismissed), Niaspan antitrust, the Allergan Biocell breast-implant suits and AndroGel post-trial matters remain open.
• Pipeline execution (Operational): Emraclidine’s Phase 2 failure led to a $3.5bn impairment, and the confirmatory Emrelis lung-cancer trial is reported to have slipped to Dec 2028.

11. Recent Developments

• 15 Oct 2026 — Record high. The shares hit an intraday high of $291.40, up from $259.93 on 01 Oct, and closed at $285.42 on 16 Oct. 15 Oct was also the ex-dividend and record date for the $1.73 dividend.
• 13 Oct 2026 — IBD data at ACG. AbbVie presented Skyrizi and Rinvoq inflammatory bowel disease data, including the Phase 3 AFFIRM study of Skyrizi subcutaneous induction.
• 07 Oct 2026 — Two Breakthrough designations for Temab-A. The FDA granted Breakthrough Therapy Designation in third-line-plus colorectal cancer with bevacizumab and in second-line-plus c-Met-positive, EGFR-wildtype NSCLC.
• 05 Oct 2026 — Guidance trimmed for IPR&D. 2026 adjusted EPS guidance moved to $13.76–$13.96 (from $13.87–$14.07) for $216m of Q3 IPR&D. The same day, epcoritamab plus R-CHOP met its PFS endpoint in the Phase 3 EPCORE DLBCL-2 trial.
• 02 Oct 2026 — 340B pilot. AbbVie joined the federal 340B Rebate Model Pilot.
• 01 Oct 2026 — Q3 date and Humira suit. AbbVie set its Q3 2026 results for 30 Oct. A judge dismissed all but one claim in the Sheet Metal Workers Humira antitrust suit.
• 30 Sep 2026 — Zumilokibart Phase 2 positive. APEX Part B data in atopic dermatitis were presented at EADV, alongside Phase 1 ABBV-295 data at EASD.
• 28 Sep 2026 — FDA approves JUVMO. Tavapadon was approved for Parkinson’s disease, with a US launch expected in Oct 2026.
• 22 Sep 2026 — Rinvoq EU approval in pJIA. The European Commission approved Rinvoq for polyarticular juvenile idiopathic arthritis.
• 10 Sep 2026 — Migraine data and dividend. Atogepant met its Phase 3 endpoints in menstrual migraine, and the board declared a $1.73 quarterly dividend payable 16 Nov 2026.
• 03 Sep 2026 — Apogee closes; CERVINO positive. AbbVie completed the ~$10.9bn Apogee acquisition at $135.11 per share and reported positive Phase 3 CERVINO results for etentamig in relapsed/refractory multiple myeloma.

12. Key Dates

• Expected Oct 2026 — US commercial launch of JUVMO (tavapadon)
• 30 Oct 2026 — Q3 2026 results before the market opens, webcast at 8:00am CT
• 16 Nov 2026 — payment date for the $1.73 quarterly dividend
• Expected late 2026 — FDA decision on Skyrizi subcutaneous induction in Crohn’s disease (guided as later in 2026; exact date not disclosed)
• 01 Jan 2027 — Medicare negotiated prices for Vraylar and Linzess take effect
• 01 Jan 2028 — Medicare negotiated price for Botox takes effect
• TBC — US decisions on Rinvoq in vitiligo and alopecia areata, and on Botox Cosmetic for masseter muscle prominence

AbbVie has announced dividend increases alongside Q3 results in most recent years. Any change will be set out in the 30 Oct release. The date for Q4 2026 results and 2027 guidance has not been announced.

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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: 16 Oct 2026

Merck & Co. (NYSE: MRK), known as MSD outside the US and Canada, is a global biopharmaceutical company built around Keytruda, the world’s best-selling cancer immunotherapy, alongside vaccines, cardiometabolic and infectious-disease medicines and an Animal Health business. The 2026 story is Merck spending heavily to diversify ahead of Keytruda’s 2028 US compound-patent expiry: the Cidara and Terns acquisitions pushed GAAP results into loss in H1 2026, while new launches such as Winrevair, Welireg, the subcutaneous Keytruda Qlex and the oral PCSK9 Lipfendra are growing quickly. This refreshed report covers results through Q2 2026, the balance sheet at 30 Jun 2026, valuation and risks, using company releases and SEC filings only.

1. Company Snapshot

Field	Value
Ticker / Exchange	MRK / NYSE
Headquarters	Rahway, New Jersey, USA
CEO / Leadership	Robert M. Davis, Chairman & CEO; Caroline Litchfield, EVP & CFO
Sector	Healthcare — pharmaceuticals, vaccines and animal health
Employees	~75,000 at 31 Dec 2025, of which ~73,000 full-time (FY2025 10-K)
Market cap	~$358.2bn ($145.19 at 15 Oct 2026 close × ~2.47bn shares)
FY2025 Revenue	$65,011m (+1.3%; +2% ex-FX)
FY2025 GAAP net income	$18,254m ($7.28 per diluted share)
FY2025 non-GAAP EPS	$8.98
2026 guidance	Sales $66.3–$67.3bn (raised 04 Aug 2026); non-GAAP EPS $2.66–$2.76, including $5.93 per share of Cidara and Terns charges
Dividend	$0.85 per quarter ($3.40 annualised; yield ~2.3%)

2. Bull & Bear Case

Bull Case

• New growth engines scaling: In Q2 2026 Winrevair sales rose 75% to $588m and Welireg 67% to $271m, Ohtuvayre added $204m, and the FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, in Jul 2026.
• Keytruda lifecycle extension: Subcutaneous Keytruda Qlex reached $463m of Q2 2026 sales, is approved in the EU and (from 21 Sep 2026) Japan across all Keytruda indications, and carries a US patent listed to 2043.
• Late-stage oncology wins: Phase 3 INTerpath-001 (intismeran plus Keytruda in melanoma) and TroFuse-005 (sac-TMT in endometrial cancer) were both positive and take three Presidential Symposium slots at ESMO 2026.
• Strong cash generation: Trailing-twelve-month operating cash flow was about $20.0bn and free cash flow about $16.1bn to 30 Jun 2026, funding a dividend raised to $0.85 a quarter.
• Guidance moving up: 2026 sales guidance was raised to $66.3–$67.3bn on 04 Aug 2026 from $65.8–$67.0bn.

Bear Case

• Keytruda concentration: Keytruda was 49% of 2025 sales; its US compound patent expires in 2028 and Merck expects it to be selected for IRA price-setting in 2027, effective 01 Jan 2029, after which US sales would “decline materially”.
• Gardasil slump: Gardasil sales fell 39% in 2025 on China and Japan weakness, and Merck expects revenue under the revised China supply contract to be immaterial in 2026.
• Deal charges crush GAAP earnings: The $9.0bn Cidara and $5.7bn Terns IPR&D charges produced an H1 2026 GAAP net loss of $5,575m and cut 2026 non-GAAP EPS guidance to $2.66–$2.76.
• Rising debt: Non-current long-term debt rose from $34.5bn at the end of 2024 to $51.1bn at 30 Jun 2026, helped by a $6.0bn bond issue in May 2026.
• Pipeline setbacks: LITESPARK-012, KEYNOTE-975 and KEYNOTE-866 missed their primary endpoints, and the ifinatamab deruxtecan small-cell lung cancer BLA was withdrawn on 25 Sep 2026.

3. Business Segments

Merck reports two operating segments. Percentages use FY2025 sales of $65,011m from the Q4 2025 earnings release.

Segment	% of revenue	What it is
Pharmaceutical	89.4% ($58,142m)	Human health medicines and vaccines: Keytruda and Keytruda Qlex ($31,680m), Gardasil/Gardasil 9 ($5,233m), Januvia/Janumet ($2,544m), ProQuad/M-M-R II/Varivax ($2,451m), Bridion ($1,841m), Lynparza and Lenvima alliance revenue, Winrevair ($1,443m), Prevymis, Vaxneuvance, Capvaxive and Welireg.
Animal Health	9.8% ($6,354m)	Livestock ($3,896m) and companion-animal ($2,458m) medicines, vaccines and monitoring, including the Bravecto parasiticide franchise.
Other revenues	0.8% ($515m)	Third-party manufacturing and other non-segment revenue.

4. Business Model & Moat

How it makes money. Merck discovers, develops, licenses and acquires patented medicines and vaccines and sells them to wholesalers, hospitals, governments and pharmacies worldwide. Non-GAAP gross margin was 81.5% in 2025, and the cash funds a large R&D budget, acquisitions and the dividend.

Buying the post-Keytruda portfolio. Merck is using its balance sheet to add late-stage assets: Verona Pharma (Ohtuvayre, closed 07 Oct 2025), Cidara (long-acting flu antiviral, about $9.2bn, Jan 2026), Terns (CML drug MK-4208, $6.8bn, 05 May 2026) and a SciBrunch KRAS G12D licence ($400m upfront, Sep 2026).

Moat. Patents, regulatory exclusivity, complex biologic and vaccine manufacturing, and Keytruda’s position as the backbone of many cancer combinations protect pricing. The subcutaneous Qlex formulation and new combination indications are designed to extend the franchise beyond the 2028 compound-patent expiry.

Cost and capital programme. A restructuring announced in Jul 2025 expects about $3.0bn of pre-tax costs and about $1.7bn of annual savings, substantially realised by end-2027. Merck has also committed more than $70bn to US capital and R&D spending, and the ADVANCE bioanalytical facility in West Point, Pennsylvania opened on 14 Oct 2026.

5. Financial Health

Annual figures are from Merck’s Q4 earnings releases and SEC XBRL filings. Long-term debt is the non-current balance-sheet amount at year end. Merck calls its adjusted measure non-GAAP EPS.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$48,704m	+17%	$5.14†	$6.02†	$2.64	$30,690m
FY2022	$59,283m	+21.7%	$5.71	$7.48	$2.80	$28,745m
FY2023	$60,115m	+1.4%	$0.14	$1.51	$2.96	$33,683m
FY2024	$64,168m	+6.7%	$6.74	$7.65	$3.12	$34,462m
FY2025	$65,011m	+1.3%	$7.28	$8.98	$3.28	$46,750m

† FY2021 revenue is continuing operations after the Jun 2021 Organon spin-off. FY2021 GAAP EPS of $5.14 includes discontinued operations; continuing-operations GAAP EPS was $4.86. FY2021 non-GAAP EPS is as originally reported; the FY2022 release restated it to $5.37. FY2023 GAAP and non-GAAP EPS include $6.21 per share of business-development charges, mainly the Prometheus acquisition. Dividends are declared per share.

Quarterly progression, most recent first, with the FY2025 total in bold:

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026	$16,607m	−$0.13	−$0.54
Q1 2026	$16,286m	−$1.28	−$1.72
Q4 2025	$16,400m	$2.04	$1.19
Q3 2025	$17,276m	$2.58	$2.32
FY2025 total	$65,011m	$8.98	$7.28

Q1 2026 includes the $9.0bn Cidara charge ($3.62 per share) and Q2 2026 the $5.7bn Terns charge ($2.31 per share), both booked as R&D with no tax benefit. Over the four quarters to 30 Jun 2026, revenue was about $66,569m, GAAP EPS about $1.25 and non-GAAP EPS about $3.21. The SciBrunch licence adds a $400m (about $0.13 per share) charge to Q3 2026.

Cash flow and balance sheet. All figures are from SEC XBRL filings (FY2025 10-K and Q2 2026 10-Q).

• Operating cash flow: $16.47bn in FY2025; ~$19.97bn trailing twelve months to 30 Jun 2026.
• Capital expenditure: $4.11bn in FY2025; ~$3.90bn trailing twelve months.
• Depreciation & amortisation: $5.85bn in FY2025 (depreciation $3.05bn, including accelerated restructuring depreciation, plus intangible amortisation $2.80bn).
• Debt at 30 Jun 2026: non-current long-term debt $51,081m and loans payable plus current portion of long-term debt $2,825m, about $53.9bn in total.
• Cash at 30 Jun 2026: cash and equivalents $6,849m plus short-term investments $292m.

6. Valuation

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

Metric	Value
Market cap	~$358.2bn (price $145.19 at 15 Oct 2026 close × ~2.47bn shares)
Enterprise value	~$405.0bn (market cap ~$358.2bn + total debt ~$53.9bn − cash and short-term investments ~$7.1bn per 30 Jun 2026 balance sheet; total debt = long-term debt $51.08bn + current debt $2.83bn)
Trailing P/E (GAAP)	~116x ($145.19 / ~$1.25 TTM GAAP EPS, Q3 2025–Q2 2026, distorted by ~$14.7bn of Cidara and Terns IPR&D charges); on TTM non-GAAP EPS of ~$3.21 the multiple is ~45x, which carries the same charges
P/E (forward)	~54x ($145.19 / $2.71, the midpoint of 2026 non-GAAP EPS guidance of $2.66–$2.76); adding back the $5.93 per share of one-time Cidara and Terns charges gives ~$8.64 and ~16.8x
P/S (TTM)	~5.4x ($358.2bn / ~$66.57bn TTM revenue)
EV/EBITDA (TTM)	~15.0x (EV ~$405.0bn / EBITDA ~$27.06bn; EBITDA = FY2025 operating income ~$21.22bn, derived as sales less cost of sales, SG&A, R&D and restructuring, + D&A $5.85bn; FY2025 used because TTM GAAP EBITDA is distorted by the H1 2026 acquired-IPR&D charges)
P/FCF	~22.3x (market cap ~$358.2bn / TTM FCF ~$16.06bn; FCF = operating CF $19.97bn − capex $3.90bn); on FY2025 FCF of ~$12.36bn ($16.47bn − $4.11bn) it is ~29.0x
Dividend yield	~2.3% ($3.40 annualised / $145.19)
52-week high	$156.92
52-week low	$82.01
Short interest (% of float)	~1.2% (~30.3m shares short at 31 Aug 2026 settlement, MarketBeat; Yahoo Finance data show ~1.15% at 30 Sep 2026)
Days to cover	~2.2 days at 31 Aug 2026 (MarketBeat); ~2.9 days at 30 Sep 2026 (Yahoo Finance)

7. What Are They Building

Merck’s pipeline is aimed at replacing Keytruda revenue from 2028 onward across oncology, cardiometabolic, infectious disease and immunology.

• Oncology: Sac-TMT (TROP2 ADC, with Kelun) is in 17 global Phase 3 trials and holds an FDA national priority voucher; intismeran (V940, with Moderna) was positive in Phase 3 INTerpath-001; calderasib (KRAS G12C) has Breakthrough Therapy designation; MK-4208 from Terns targets CML; and SPR2015 adds an oral KRAS G12D (ON) inhibitor.
• Cardiometabolic: Lipfendra (enlicitide) cut LDL-C by 56–59% placebo-adjusted at week 24 in the CORALreef trials and was approved in Jul 2026. Winrevair gained the HYPERION label on 22 Sep 2026, and a Phase 3 is planned in CpcPH-HFpEF after a positive Phase 2.
• Infectious disease: IDVYNSO (doravirine/islatravir) was approved in Apr 2026; once-weekly islatravir/lenacapavir (with Gilead) was positive in Phase 3; once-monthly oral PrEP alimatravir is in Phase 3; and MK-1406 from Cidara is a long-acting flu preventive in Phase 3.
• Immunology and ophthalmology: Anti-TL1A tulisokibart was positive in the ATLAS-UC Phase 3 induction study and a Phase 2b in hidradenitis suppurativa, but failed in SSc-ILD; remigromig met its pivotal endpoint in diabetic macular edema.

8. Competitive Landscape

Merck competes with the other global large-cap pharmaceutical groups, and with Bristol-Myers Squibb, AstraZeneca and Roche in immuno-oncology in particular. Market caps are at the 15 Oct 2026 close. Metrics come from each company’s FY2025 results release.

Peer	Market cap (Oct 2026)	Key 2025 metric
Eli Lilly (LLY)	~$1,116bn	FY2025 revenue $65,179m, +45%, per Lilly Q4 2025 release
Johnson & Johnson (JNJ)	~$610bn	FY2025 sales ~$94.2bn, +6.0%, per J&J Q4 2025 release
AbbVie (ABBV)	~$501bn	FY2025 net revenue $61,160m, +8.6%, per AbbVie Q4 2025 release
AstraZeneca (AZN)	~$259bn	FY2025 total revenue $58,739m, +8% at constant exchange rates; core EPS $9.16, per AstraZeneca FY2025 results
Pfizer (PFE)	~$168bn	FY2025 revenue $62,579m, −2% operationally, per Pfizer Q4 2025 release
Bristol-Myers Squibb (BMY)	~$124bn	FY2025 revenue ~$48.2bn, roughly flat; non-GAAP EPS $6.15, per BMS Q4 2025 release

9. Leadership & Insider Activity

Robert M. Davis is Chairman and CEO and Caroline Litchfield is EVP and CFO. Paul J. Diaz joined the board on 13 Oct 2026. After the share price recovery that followed the Q2 results, several executive officers sold stock in Aug 2026, about $30m in total, mostly after exercising options; no open-market purchases were reported. Davis received his annual equity award (187,421 shares) on 05 May 2026 and made no open-market trades in the period reviewed. Plan type is not shown in the filing summaries reviewed.

Name	Date	Type	Shares	Price	Value	Plan Type
Chirfi Guindo (EVP, Access, Policy & Comms)	13 Aug 2026	Sale	10,000	$135.00	~$1.35m	Open market; plan status not stated
Jennifer Zachary (EVP & General Counsel)	12 Aug 2026	Sale	80,315	$133.46	~$10.72m	Open market after option exercise; plan status not stated
Richard DeLuca (EVP, President Animal Health)	10 Aug 2026	Sale	45,320	$131.12	~$5.94m	Open market; plan status not stated
Richard DeLuca (EVP, President Animal Health)	06 Aug 2026	Sale	6,050	$130.38	~$0.79m	Open market; plan status not stated
Chirfi Guindo (EVP, Access, Policy & Comms)	06 Aug 2026	Sale	15,000	$131.00	~$1.97m	Open market; plan status not stated
David Williams (EVP, Chief Information & Digital Officer)	05 Aug 2026	Sale	52,847	$128.77	~$6.81m	Open market after option exercise; plan status not stated
David Maraldo (EVP, President MMD)	05 Aug 2026	Sale	18,706	$128.72	~$2.41m	Open market after option exercise; plan status not stated

10. Key Risks

• Keytruda exclusivity and IRA (Regulatory): The US compound patent expires in 2028, with two further patents to 2029 that Merck expects to be litigated; exclusivity runs to 2031 in the EU and 2028 in China. Expected IRA selection in 2027 would set a Medicare price from 01 Jan 2029. Lenvima’s set price applies from 01 Jan 2028.
• Wider loss of exclusivity (Commercial): Januvia/Janumet and Bridion lose exclusivity in 2026 (Januvia/Janumet sales fell 31% in Q2 2026), followed by Bravecto, Lynparza and Winrevair’s compound patent in 2027 and Gardasil in 2028.
• Gardasil in China (Commercial): Shipments were suspended in Feb 2025; limited shipments resumed in Q2 2026 under a revised Zhifei contract, but Merck expects the revenue to be immaterial in 2026.
• Leverage and deal integration (Financial): Non-current long-term debt reached $51.1bn at 30 Jun 2026 and net interest expense is rising, while three acquisitions and a licence in nine months must deliver to justify about $15bn of 2026 IPR&D charges.
• Pipeline execution (Operational): Recent Phase 3 misses (LITESPARK-012, KEYNOTE-975, KEYNOTE-866) and the I-DXd BLA withdrawal show the risk that replacement assets fall short.
• Pricing and tariffs (Regulatory): Merck’s voluntary agreement with the US government covers most-favoured-nation pricing and a direct-to-patient programme in return for a three-year Section 232 tariff delay; the detailed pricing terms are not disclosed.

11. Recent Developments

• 14 Oct 2026 — ADVANCE facility opens. Merck inaugurated its ADVANCE bioanalytical facility on the West Point, Pennsylvania campus, part of its US investment commitment.
• 13 Oct 2026 — Three ESMO Presidential Symposium slots. Merck will present INTerpath-001 (intismeran plus Keytruda in melanoma), TroFuse-005 (sac-TMT in endometrial cancer) and KEYNOTE-C93 at ESMO 2026.
• 13 Oct 2026 — New director. Paul J. Diaz was elected to Merck’s board of directors.
• 10 Oct 2026 — Remigromig one-year data. One-year BRUNELLO results in diabetic macular edema were presented at AAO 2026, after the pivotal trial met its primary endpoint on 24 Sep 2026.
• 30 Sep 2026 — Tulisokibart Phase 2b success. The anti-TL1A antibody met its primary and key secondary endpoints in hidradenitis suppurativa.
• 28 Sep 2026 — SciBrunch KRAS G12D licence. Merck licensed preclinical oral inhibitor SPR2015 for $400m upfront and up to $2.13bn in total, adding a $400m charge to Q3 2026.
• 25 Sep 2026 — FDA approves Welireg plus Lenvima. The combination was approved for certain previously treated advanced clear-cell renal cell carcinoma based on LITESPARK-011.
• 25 Sep 2026 — I-DXd BLA withdrawn. The application for ifinatamab deruxtecan (with Daiichi Sankyo) in extensive-stage small-cell lung cancer was voluntarily withdrawn after the FDA said the Phase 2 data did not support accelerated approval.
• 22 Sep 2026 — Winrevair label update. The FDA approved adding Phase 3 HYPERION data in newly diagnosed pulmonary arterial hypertension.
• 21 Sep 2026 — Keytruda Qlex approved in Japan. The subcutaneous formulation was approved for all Keytruda indications.
• 04 Aug 2026 — Q2 2026 results. Sales rose 5% to $16,607m; GAAP EPS was −$0.54 and non-GAAP EPS −$0.13 after the $2.31 per share Terns charge. Sales guidance was raised.

12. Key Dates

• 23 Oct 2026 — ESMO 2026 opens in Madrid (to 27 Oct), with Merck’s three Presidential Symposium presentations including INTerpath-001 as LBA1
• 26 Oct 2026 — Merck Oncology Investor Event at ESMO (1:00pm EDT)
• 29 Oct 2026 — Q3 2026 results and conference call (9:00am ET)
• Expected Feb 2027 — Q4 and full-year 2026 results with 2027 guidance (FY2025 results were released on 03 Feb 2026)
• 22 Mar 2027 — FDA PDUFA date for the Enflonsia (clesrovimab) second-RSV-season label expansion

The next quarterly dividend declaration date has not yet been announced; the last $0.85 payment was made on 07 Oct 2026.

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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: 16 Oct 2026

Pfizer (NYSE: PFE) is one of the world’s largest biopharmaceutical companies, selling medicines and vaccines across primary care, specialty care, oncology and hospital markets. The investment story in 2026 is a race between new growth drivers (Seagen oncology assets, the Metsera obesity programme, a PD-1xVEGF bispecific and a string of new launches) and a heavy loss-of-exclusivity cliff for Eliquis, Ibrance, Xtandi and other blockbusters, while COVID revenue keeps shrinking. This refreshed report covers results through Q2 2026, the balance sheet at 28 Jun 2026, valuation and risks, using company releases and SEC filings only.

1. Company Snapshot

Field	Value
Ticker / Exchange	PFE / NYSE
Headquarters	66 Hudson Boulevard East, New York, NY, USA
CEO / Leadership	Dr. Albert Bourla, Chairman & CEO; Cecile Guegan, Interim CFO since 16 Aug 2026 (Dave Denton left 15 Aug 2026)
Sector	Healthcare — biopharmaceuticals and vaccines
Employees	~75,000 at 31 Dec 2025 (FY2025 10-K)
Market cap	~$167.8bn ($29.44 at 15 Oct 2026 close × ~5.70bn shares)
FY2025 Revenue	$62,579m (−1.6%; +6% operationally excluding Comirnaty and Paxlovid)
FY2025 GAAP net income	$7,771m ($1.36 per diluted share)
FY2025 adjusted EPS	$3.22
2026 guidance	Revenue $60.5–$62.5bn (raised 04 Aug 2026); adjusted EPS $2.80–$3.00 (reaffirmed)
Dividend	$0.43 per quarter ($1.72 annualised; yield ~5.8%)

2. Bull & Bear Case

Bull Case

• Insiders buying the dip: CEO Albert Bourla bought 38,000 shares (~$1.0m) on 12 Aug 2026, and directors Mortimer Buckley and Ronald Blaylock each bought close to $1.0m of stock on 05 Aug 2026 after the Q2 report.
• Non-COVID growth is real: Excluding Comirnaty and Paxlovid, Q2 2026 revenue grew 5% operationally, launched and acquired products grew 18%, and full-year revenue guidance was raised to $60.5–$62.5bn.
• Oncology launches landing: Padcev sales rose 23% in Q2 2026 after its July 2026 muscle-invasive bladder cancer approval, and Tukysa won FDA approval as first-line HER2+ maintenance therapy on 07 Oct 2026.
• Large obesity and bispecific bets: Pfizer plans 10 Phase 3 studies in 2026 for monthly GLP-1 berobenatide (from Metsera) and is running pivotal trials of PD-1xVEGF bispecific tivunatamig in lung, colorectal and endometrial cancer.
• Dividend backed by cash flow: Trailing-twelve-month free cash flow of ~$11.0bn to 28 Jun 2026 exceeds the ~$9.8bn annual dividend bill, and the 06 Oct 2026 declaration was Pfizer’s 352nd consecutive quarterly dividend.

Bear Case

• Patent cliff: US basic patents for Xeljanz, Prevnar 13 and Adcetris expire in 2026 and Ibrance and Xtandi in 2027, while settled Eliquis generic entry is 01 Apr 2028; 2026 guidance already absorbs about $1.1bn of LOE revenue loss.
• COVID franchise fading: Paxlovid sales fell 95% and Comirnaty 34% in Q2 2026, and COVID revenue guidance was cut to about $4bn from about $5bn.
• Write-downs hit GAAP earnings: Q2 2026 carried $4.3bn of impairments ($3.8bn for sigvotatug vedotin after its Phase 3 overall-survival miss, $525m for Oxbryta), leaving trailing GAAP EPS at about $0.76.
• Heavy debt, no buybacks: Total debt was about $63.2bn at 28 Jun 2026, and guidance assumes no share repurchases in 2026.
• US price controls: Medicare negotiated prices apply to Eliquis from 2026 and to Ibrance and Xtandi from 01 Jan 2027, on top of the voluntary most-favoured-nation pricing agreement signed in Sep 2025.

3. Business Segments

Pfizer’s only reportable segment is Biopharma (97.8% of FY2025 revenue); Pfizer CentreOne contract manufacturing and the wind-down Pfizer Ignite unit make up the rest. Inside Biopharma, revenue is disclosed by customer category. Percentages use FY2025 revenue of $62,579m from the Q4 2025 earnings release. From 01 Jan 2026 a separate Hospital & Biosimilars category is also reported.

Segment / category	% of revenue	What it is
Biopharma — Primary Care	42.9% ($26,820m)	Eliquis ($7,961m), the Prevnar pneumococcal vaccine family ($6,494m), Comirnaty ($4,367m), Paxlovid ($2,362m), Nurtec ODT/Vydura and Abrysvo.
Biopharma — Specialty Care	28.0% ($17,546m)	The Vyndaqel ATTR-CM family ($6,380m), Xeljanz ($1,087m), inflammation, immunology, rare-disease and hospital products.
Biopharma — Oncology	26.9% ($16,834m)	Ibrance ($4,122m), Xtandi ($2,194m), Padcev ($1,940m) and the wider Seagen antibody-drug conjugate portfolio.
Pfizer CentreOne	2.1% ($1,338m)	Contract development and manufacturing for third parties.
Pfizer Ignite	0.1% ($41m)	Biotech R&D services unit, now being wound down.

4. Business Model & Moat

How it makes money. Pfizer discovers, develops, licenses and acquires patented medicines and vaccines, then sells them to wholesalers, hospitals, governments and pharmacies worldwide. Gross margins on patented drugs are high, and the cash funds R&D (adjusted R&D guidance $10.5–$11.5bn for 2026), deal-making and one of the sector’s largest dividend bills.

Replacing lost revenue by deal. Pfizer has bought growth to refill the LOE gap: Seagen in 2023 (funded by about $31bn of notes), Metsera in Nov 2025 (up to about $10bn including a CVR), the 3SBio PD-1xVEGF licence in 2025 and an Innovent oncology licence that closed on 10 Jul 2026 ($650m upfront, up to $9.85bn in milestones).

Moat. Patents, regulatory exclusivity, global manufacturing scale and vaccine know-how protect pricing until each product’s exclusivity ends. Prevnar 20 is protected to 2035 in the US, and a settlement puts effective Vyndamax US expiry at 01 Jun 2031. The moat is product-by-product, so it has to be rebuilt continually through the pipeline.

Cost discipline. Cost programmes now target $6.7bn of net savings through 2029 plus $3.0bn of manufacturing savings, and a further $2.5bn of productivity savings for 2027–2029 was announced with Q2 2026 results.

5. Financial Health

Annual figures are from Pfizer’s Q4 earnings releases and SEC XBRL filings. Long-term debt is the non-current balance-sheet amount at year end.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$81,288m	+95.2%	$3.85	$4.42†	$1.57	$36,195m
FY2022	$100,330m	+23.4%	$5.47	$6.58	$1.61	$32,884m
FY2023	$58,496m	−41.7%	$0.37	$1.84	$1.65	$61,538m
FY2024	$63,627m	+8.8%	$1.41	$3.11	$1.69	$57,405m
FY2025	$62,579m	−1.6%	$1.36	$3.22	$1.72	$61,641m

† FY2021 adjusted EPS as originally reported; the FY2022 release restated it to $4.06. FY2021 and FY2022 revenue were inflated by Comirnaty and Paxlovid. The FY2023 debt step-up reflects about $31bn of notes issued for Seagen. Dividends are declared per share.

Quarterly progression, most recent first, with the FY2025 total in bold:

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026	$15,034m	$0.77	−$0.04
Q1 2026	$14,451m	$0.75	$0.47
Q4 2025	$17,557m	$0.66	−$0.29
Q3 2025	$16,654m	$0.87	$0.62
FY2025 total	$62,579m	$3.22	$1.36

Q2 2026 GAAP EPS absorbed $4.3bn of intangible impairments; Q3 2025 GAAP EPS absorbed a $1.35bn acquired IPR&D charge for the 3SBio licence. Over the four quarters to 28 Jun 2026, revenue was about $63,696m, GAAP EPS about $0.76 and adjusted EPS about $3.05.

Cash flow and balance sheet. All figures are from SEC XBRL filings (FY2025 10-K and Q2 2026 10-Q).

• Operating cash flow: $11.70bn in FY2025; ~$13.40bn trailing twelve months to 28 Jun 2026.
• Capital expenditure: $2.63bn in FY2025; ~$2.42bn trailing twelve months.
• Depreciation & amortisation: $6.59bn in FY2025 (total D&A including $4.87bn of intangible amortisation); ~$6.58bn trailing twelve months.
• Debt at 28 Jun 2026: non-current long-term debt $60,495m and short-term borrowings including current maturities $2,699m, about $63.2bn in total. No new long-term debt was issued in H1 2026 and $1.25bn was repaid.
• Cash at 28 Jun 2026: cash $976m plus short-term investments $10,723m.

6. Valuation

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

Metric	Value
Market cap	~$167.8bn (price $29.44 at 15 Oct 2026 close × ~5.70bn shares)
Enterprise value	~$219.3bn (market cap ~$167.8bn + total debt ~$63.2bn − cash and short-term investments ~$11.7bn per 28 Jun 2026 balance sheet; total debt = long-term debt $60.50bn + short-term borrowings $2.70bn)
Trailing P/E (GAAP)	~38.7x ($29.44 / ~$0.76 TTM GAAP EPS, Q3 2025–Q2 2026, depressed by impairments and IPR&D charges); on TTM adjusted EPS of ~$3.05 the multiple is ~9.7x
P/E (forward)	~10.2x ($29.44 / $2.90, the midpoint of 2026 adjusted EPS guidance of $2.80–$3.00)
P/S (TTM)	~2.6x ($167.8bn / ~$63.70bn TTM revenue)
EV/EBITDA (TTM)	~10.5x (EV ~$219.3bn / EBITDA ~$20.84bn; EBITDA = FY2025 operating income ~$14.24bn, derived as revenue less cost of sales, SI&A, R&D, acquired IPR&D, amortisation and restructuring, + total D&A $6.59bn; latest full year used because Pfizer does not report an operating-income line)
P/FCF	~15.3x (market cap ~$167.8bn / TTM FCF ~$10.99bn; FCF = operating CF $13.40bn − capex $2.42bn); on FY2025 FCF of ~$9.08bn ($11.70bn − $2.63bn) it is ~18.5x
Dividend yield	~5.8% ($1.72 annualised / $29.44)
52-week high	$29.88 (15 Oct 2026)
52-week low	$23.62
Short interest (% of float)	~2.65% (~150.2m shares short at 30 Sep 2026 settlement, MarketBeat)
Days to cover	~4.4 days

7. What Are They Building

Pfizer’s pipeline is built to replace roughly the revenue it loses to generics and price controls between 2026 and 2028.

• Obesity: Berobenatide (PF’3944, formerly MET-097i), a monthly injectable GLP-1 from Metsera, reported Phase 2b VESPER data in Jun 2026. Pfizer plans 10 Phase 3 studies in 2026 within a programme of more than 20 obesity trials, and has also in-licensed YaoPharma’s oral GLP-1 YP05002.
• PD-1xVEGF bispecific: Tivunatamig (PF-08634404), licensed from 3SBio, is in pivotal studies in first-line non-small cell lung, colorectal and endometrial cancer, with updated lung data due at ESMO 2026.
• Antibody-drug conjugates: Padcev and Tukysa label expansions in 2026; sigvotatug vedotin continues in a first-line Phase 3 with pembrolizumab despite the second-line miss; 12 Innovent oncology programmes added in Jul 2026.
• Breast and prostate cancer: Atirmociclib (CDK4 inhibitor) is in a first-line Phase 3; Talzenna plus Xtandi in HRR-mutated mCSPC has a priority-review FDA decision due in Q4 2026; mevrometostat is in prostate cancer studies.
• Immunology and vaccines: Tilrekimig (IL-4/IL-13/TSLP trispecific) is moving to Phase 3 in atopic dermatitis and asthma; Litfulo filings are planned in vitiligo; a 25-valent pneumococcal vaccine began paediatric Phase 3 in May 2026; and the Lyme vaccine with Valneva is under EMA review.

8. Competitive Landscape

Pfizer competes with the other global large-cap pharmaceutical groups. Market caps are at the 15 Oct 2026 close. Metrics come from each company’s FY2025 results release.

Peer	Market cap (Oct 2026)	Key 2025 metric
Eli Lilly (LLY)	~$1,116bn	FY2025 revenue ~$65.2bn, +45%, per Lilly Q4 2025 release
Johnson & Johnson (JNJ)	~$610bn	FY2025 sales ~$94.2bn, +6.0%, per J&J Q4 2025 release
AbbVie (ABBV)	~$501bn	FY2025 net revenue $61,160m, +8.6%, per AbbVie Q4 2025 release
Merck & Co. (MRK)	~$358bn	FY2025 sales $65,011m, +1%, per Merck Q4 2025 release
AstraZeneca (AZN)	~$259bn	FY2025 total revenue $58,739m, +8% at constant exchange rates, per AstraZeneca FY2025 results
Bristol-Myers Squibb (BMY)	~$124bn	FY2025 revenue ~$48.2bn, roughly flat, per BMS Q4 2025 release

9. Leadership & Insider Activity

Dr. Albert Bourla is Chairman and CEO. Cecile Guegan became Interim CFO on 16 Aug 2026 after Dave Denton left; a permanent CFO search is ongoing. In 2026 Form 4 filings show open-market purchases by the CEO and two directors after the Q2 results, and two small sales by the Controller. Bourla’s purchase left him with 429,173 shares held directly. Other Sep–Oct 2026 filings were routine director deferred-stock awards and phantom-unit credits.

Name	Date	Type	Shares	Price	Value	Plan Type
Albert Bourla (Chairman & CEO)	12 Aug 2026	Purchase	38,000	$26.34	~$1.00m	Open market; no 10b5-1 indication
Mortimer J. Buckley (Director)	05 Aug 2026	Purchase	37,632	$25.52	~$0.96m	Open market; new position
Ronald E. Blaylock (Director)	05 Aug 2026	Purchase	39,231	$25.46	~$1.00m	Open market
Jennifer B. Damico (SVP & Controller)	05 Aug 2026	Sale	3,278	$25.40	~$0.08m	Open market; no 10b5-1 indication
Jennifer B. Damico (SVP & Controller)	09 Jun 2026	Sale	2,000	$25.70	~$0.05m	Open market; plan status not stated

10. Key Risks

• Loss of exclusivity (Commercial): Xeljanz, Prevnar 13, Adcetris and the Vyndaqel family face 2026 US expiries, Ibrance and Xtandi 2027, and Eliquis generics are settled for 01 Apr 2028. If the Eliquis formulation patent were invalidated, generics could launch as early as 21 Nov 2026.
• US drug pricing (Regulatory): IRA negotiated prices cover Eliquis (2026), Ibrance and Xtandi (2027) and Xeljanz (2028). The voluntary most-favoured-nation agreement and TrumpRx participation trade price concessions for a three-year Section 232 tariff grace period tied to about $70bn of US investment.
• Pipeline and impairment (Operational): The $3.8bn sigvotatug vedotin write-down shows how acquired assets can fail. The obesity programme must compete against established GLP-1 incumbents in a costly Phase 3 build-out.
• Leverage (Financial): Total debt of about $63.2bn and H1 2026 interest expense of $1,336m limit flexibility; the ~$9.8bn dividend absorbs most free cash flow and no buybacks are planned.
• Litigation (Legal): The Depo-Provera meningioma MDL 3140 heads to a first bellwether trial in Dec 2026, and Q2 2026 legal charges were $842m.
• COVID revenue run-off (Commercial): COVID products are guided to about $4bn in 2026 after the cut from about $5bn, with Paxlovid nearly gone in Q2.
• Leadership transition (Operational): The CFO role has been held on an interim basis since 16 Aug 2026 during a large cost-cutting and restructuring programme, including about 330 job cuts in Catania, Italy.

11. Recent Developments

• 15 Oct 2026 — New 52-week high. The shares reached $29.88 in a sector-wide rally, closing at $29.44, after setting a new 12-month high the day before.
• 14 Oct 2026 — IDWeek line-up. Pfizer said it will present more than 50 abstracts at IDWeek on 21–24 Oct, including Phase 3 VALOR results for its Lyme disease vaccine and RSV data.
• 07 Oct 2026 — FDA approves Tukysa regimen. Tukysa with trastuzumab and pertuzumab was approved as first-line maintenance for HER2+ metastatic breast cancer; median progression-free survival was 24.9 months against 16.3 months in HER2CLIMB-05.
• 07 Oct 2026 — Catania job cuts confirmed. Talks at Italy’s Industry Ministry ended with about 330 of 550 job cuts and the closure of the penicillin unit confirmed; further talks are set for 10 Nov.
• 06 Oct 2026 — Q4 dividend declared. The board declared $0.43 per share, Pfizer’s 352nd consecutive quarterly dividend, payable 07 Dec 2026 to holders of record on 06 Nov 2026.
• 02 Oct 2026 — Litfulo vitiligo data. Detailed Phase 3 results showed Litfulo significantly improved facial and total-body repigmentation in nonsegmental vitiligo.
• 01 Oct 2026 — Tilrekimig Phase 2. The IL-4/IL-13/TSLP trispecific showed significant skin clearance in a Phase 2 atopic dermatitis study.
• 28 Sep 2026 — ESMO preview. Pfizer will present 45 abstracts at ESMO, including late-breaking SigVie-002 overall-survival data for sigvotatug vedotin and updated tivunatamig lung data.
• 22 Sep 2026 — Q3 date set. Pfizer will publish Q3 2026 results and hold its call on 03 Nov 2026.
• 04 Aug 2026 — Q2 2026 results. Revenue was $15,034m (+3%), adjusted EPS $0.77 and GAAP EPS −$0.04 after $4.3bn of impairments. Revenue guidance was raised and adjusted EPS guidance of $2.80–$3.00 reaffirmed.

12. Key Dates

• 21 Oct 2026 — IDWeek opens (to 24 Oct), with Phase 3 Lyme vaccine data
• 23 Oct 2026 — ESMO 2026 opens in Madrid (to 27 Oct); SigVie-002 late-breaker on 25 Oct
• 03 Nov 2026 — Q3 2026 results and conference call (10:00am ET)
• 06 Nov 2026 — record date for the $0.43 quarterly dividend
• 10 Nov 2026 — next round of Catania labour talks
• 21 Nov 2026 — Eliquis US composition patent expires (settled generic entry 01 Apr 2028)
• Expected Dec 2026 — FDA decision on Talzenna plus Xtandi in HRR-mutated mCSPC (Q4 2026 PDUFA) and first Depo-Provera bellwether trial
• 07 Dec 2026 — quarterly dividend payment date
• 01 Jan 2027 — Medicare negotiated prices for Ibrance and Xtandi take effect

The date for Q4 2026 results and 2027 guidance has not yet been announced.

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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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