Healthcare & Pharma

Last Updated: 16 May 2026

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

1. Company Snapshot

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

2. Bull Case vs Bear Case

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

Bull Case

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

Bear Case

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

3. What Does This Company Actually Do?

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

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

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

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

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

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

4. The Business Model

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

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

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

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

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

5. Financial Health

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

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

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

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

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

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

Quarterly breakdown (most recent first):

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

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

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

6. Valuation & Market Data

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

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

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

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

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

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

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

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

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

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

8. Competitive Landscape

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

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

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

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

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

9. Leadership and Ownership

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

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

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

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

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

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

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

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

10. Risks and Challenges

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

11. Recent Developments

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

12. Key Dates Coming Up

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

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Last Updated: 30 Sep 2026

Eli Lilly and Company (NYSE: LLY) is an Indianapolis-based pharmaceutical company, founded in 1876. It discovers, makes and sells medicines for diabetes, obesity, cancer, immunology and neuroscience. Its incretin drugs are now the largest part of the business: tirzepatide, sold as Mounjaro for type 2 diabetes and Zepbound for obesity, and the new once-daily pill Foundayo (orforglipron).

FY2025 revenue rose 45% to $65,179m. Growth then sped up again: Q2 2026 revenue was $22,974m (+48%), and on 5 Aug 2026 Lilly raised its 2026 revenue guidance to $85–87bn. The stock is worth about $1.06 trillion. Mounjaro and Zepbound together were about 65% of H1 2026 revenue, and prices are falling as volume grows.

This refresh draws on Lilly earnings releases (SEC 8-K exhibits), the FY2025 Form 10-K, the Q2 2026 Form 10-Q, SEC XBRL company facts and Form 4 filings, all retrieved on 30 Sep 2026. Follow the price on ChartsView Live Charts.

1. Company Snapshot

Field	Value
Full name	Eli Lilly and Company
Ticker	LLY (NYSE)
Sector	Healthcare & Pharma
Industry	Pharmaceuticals: cardiometabolic, oncology, immunology, neuroscience
Headquarters	Indianapolis, Indiana
Founded	1876 (publicly traded since 1952)
CEO / Leadership	David A. Ricks (Chair and CEO); Lucas Montarce (EVP and CFO)
Market cap	~$1,056bn (891.4m shares × $1,184.63 at the 29 Sep 2026 close)
Revenue (FY2025)	$65,179m (+44.7% YoY)
Net income (FY2025)	$20,640m GAAP; diluted EPS $22.95, non-GAAP EPS $24.21
Employees	About 50,000 at year-end 2025 (about 27,000 outside the US), per the FY2025 10-K
Dividend	$1.73 per quarter ($6.92 annualised), raised 15% for 2026

2. Bull Case vs Bear Case

Distilled from the full report below. Factual only, no ratings.

Bull Case

Incretin market leadership: Mounjaro ($22,965m) and Zepbound ($13,542m) brought in $36.5bn in FY2025. Lilly holds about 60% of the US weight-loss drug market, against about 38% for Novo Nordisk (Motley Fool, 17 Sep 2026).
Guidance raised twice in 2026: Revenue guidance rose from $80–83bn in February to $85–87bn on 5 Aug 2026. Volume grew 60% in Q2 2026, and non-GAAP gross margin was 86.3%.
Deep late-stage pipeline: Foundayo was approved on 1 Apr 2026 and Onswik, a once-weekly insulin, on 24 Sep 2026. Retatrutide produced 20.8% weight loss at 80 weeks in TRIUMPH-2, and a US filing is planned for Q1 2027.
US manufacturing and pricing agreement: Lilly has committed more than $50bn to US manufacturing, including a $6.5bn Houston API plant started on 21 Sep 2026. Its Nov 2025 agreement with the US government gives it three years of tariff relief.

Bear Case

Heavy product concentration: Tirzepatide was about 56% of FY2025 revenue and about 65% of H1 2026 revenue, so a large share of sales depends on one molecule.
Falling prices: Worldwide realised prices fell 13% in Q2 2026 and outside-US prices fell 36% after Mounjaro joined China's national reimbursement list (NRDL). Medicare patients now pay $50 a month for Zepbound, and self-pay prices keep falling.
High valuation multiples: The shares trade at about 40x trailing GAAP earnings and about 13x trailing sales, so any slowdown in growth would weigh heavily.
Oral GLP-1 competition: Novo's Wegovy pill had about 183,000 scripts against about 47,500 for Foundayo (Citi/IQVIA via FiercePharma), and Novo is publishing studies that compare its drugs with Mounjaro.

3. What Does This Company Actually Do?

Lilly develops, makes and sells prescription medicines. It reports one operating segment, human pharmaceutical products. Its main franchises are:

cardiometabolic health: Mounjaro, Zepbound, Foundayo, Trulicity, Jardiance (with Boehringer Ingelheim) and insulins;
oncology: Verzenio, Jaypirca and Inluriyo;
immunology: Taltz, Ebglyss and Olumiant;
neuroscience: Kisunla for early Alzheimer's disease.

Segment / product	% of revenue	What it is
Mounjaro	35.2% ($22,965m)	Tirzepatide injection for type 2 diabetes (GIP/GLP-1 dual agonist)
Zepbound	20.8% ($13,542m)	Tirzepatide for chronic weight management and obstructive sleep apnea
Verzenio	8.8% ($5,723m)	CDK4/6 inhibitor for HR+/HER2- breast cancer
Trulicity	6.6% ($4,276m)	Older once-weekly GLP-1 for type 2 diabetes; sales are declining
Taltz	5.5% ($3,563m)	IL-17A antibody for psoriasis and psoriatic arthritis
Jardiance	5.3% ($3,432m)	SGLT2 inhibitor sold with Boehringer Ingelheim
All other products	17.9% ($11,678m)	Insulins, Olumiant, Emgality, Jaypirca, Ebglyss, Kisunla, Cyramza and others

Shares of FY2025 revenue of $65,179m, per the FY2025 10-K product table. US revenue was $43,481m (66.7%) and outside-US revenue $21,698m (33.3%). In H1 2026 (revenue $42,773m), Mounjaro was $18,605m (43.5%), Zepbound $9,088m (21.2%), Kisunla $291m and Foundayo $98m.

4. The Business Model

How it makes money. Lilly earns high margins on patented medicines; its non-GAAP gross margin was 86.3% in Q2 2026. It reinvests heavily in R&D and, increasingly, in manufacturing. Revenue is roughly 62% US and 38% outside the US (H1 2026). US net prices depend on rebates to pharmacy benefit managers, Medicare and Medicaid terms, and a fast-growing self-pay channel (LillyDirect), where Zepbound multi-dose pens cost $299–$449 a month.

Where the moat sits. Lilly's moat has three parts:

patents: the US compound patent on tirzepatide runs to 2036;
know-how in incretin biology: tirzepatide, orforglipron and the triple agonist retatrutide;
manufacturing scale: hard-to-replicate injectable and API capacity, now being expanded across 10 US sites announced since 2020.

What changed in 2025–2026. Lilly has shifted from supply shortages to volume-led growth at lower prices. Q2 2026 volume rose 60% while realised prices fell 13%. Its 6 Nov 2025 agreement with the US government set Medicare and self-pay prices in exchange for tariff relief. Lilly has also been buying pipeline assets heavily: Verve, SiteOne, Adverum, Ventyx, Centessa (about $7.8bn), Kelonia and AtaiBeckley.

5. Financial Health

Sources: Lilly quarterly and annual earnings releases (SEC 8-K exhibits), the FY2025 Form 10-K, the Q2 2026 Form 10-Q, and SEC XBRL company facts (data.sec.gov) for debt, cash, cash flow, D&A and operating income. Fiscal year ends 31 December.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$28,318m	+15.4%	$6.12	$7.39†	$3.40	$15,346m
FY2022	$28,541m	+0.8%	$6.90	$7.94	$3.92	$14,738m
FY2023	$34,124m	+19.6%	$5.80	$6.32	$4.52	$18,321m
FY2024	$45,043m	+32.0%	$11.71	$12.99	$5.20	$28,527m
FY2025	$65,179m	+44.7%	$22.95	$24.21	$6.00	$40,868m

Adjusted EPS is Lilly's non-GAAP EPS. † The FY2021 figure is as recast in the Feb 2023 release to include acquired IPR&D. FY2020 revenue was $24,540m (the base for the FY2021 YoY). Dividend/share is dividends paid per share in the year. Long-term debt is the noncurrent portion at year-end, from SEC XBRL (LongTermDebtNoncurrent). At 30 Jun 2026, noncurrent long-term debt was $47,858m and short-term borrowings plus current debt, including commercial paper, were $7,050m.

Quarterly results (most recent first)

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026 (to 30 Jun 2026)	$22,974m	$8.38	$7.94
Q1 2026 (to 31 Mar 2026)	$19,799m	$8.55	$8.26
Q4 2025 (to 31 Dec 2025)	$19,292m	$7.54	$7.39
Q3 2025 (to 30 Sep 2025)	$17,601m	$7.02	$6.21
H1 2025 (Q1 + Q2)‡	$28,286m	$9.65	$9.35
FY2025 total	$65,179m	$24.21	$22.95

‡ H1 2025 revenue and GAAP EPS are from the Q2 2025 10-Q. H1 2025 non-GAAP EPS is derived as the FY2025 total less Q3 and Q4, so it is approximate. Both Q2 2026 EPS figures include $3.03 per share of acquired IPR&D charges.

Cash flow and balance sheet.

Cash flow (FY2025).
- Operating cash flow was $16,813m and capital expenditure $7,841m, giving free cash flow of $8,972m.
- Depreciation and amortisation was $1,997m. Operating income was $26,302m (pre-tax income $25,731m plus $571m of net other expense).
Cash flow (H1 2026). Operating cash flow was $16,023m and capex $5,259m. Trailing twelve months (TTM) operating cash flow was about $28.1bn and TTM capex about $9.9bn.
Balance sheet at 30 Jun 2026. Cash and cash equivalents were $8,950m and total debt about $54.9bn. Debt rose after $9bn of notes were issued in May 2026 to fund acquisitions.
2026 guidance (raised 5 Aug 2026):
- revenue of $85–87bn;
- non-GAAP EPS of $35.50–36.50;
- performance margin of 49.0–50.5%;
- a tax rate of 18–19%.
The guidance excludes acquired IPR&D incurred after 30 Jun 2026.

6. Valuation & Market Data

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

Metric	Value
Market cap	~$1,056bn (891.4m shares × $1,184.63 at the 29 Sep 2026 close)
Enterprise value	~$1,102bn. Calculated as market cap ~$1,056bn + total debt ~$54.9bn (noncurrent long-term debt $47.9bn + current debt and commercial paper $7.1bn) − cash ~$9.0bn, per the 30 Jun 2026 balance sheet
Trailing P/E (GAAP)	~39.8x ($1,184.63 / TTM GAAP diluted EPS of $29.79, Q3 2025 to Q2 2026). On TTM non-GAAP EPS of about $31.49 the multiple is ~37.6x
P/E (forward)	~32.9x ($1,184.63 / midpoint of 2026 non-GAAP EPS guidance, $36.00)
P/S (TTM)	~13.3x (market cap / TTM revenue of $79.7bn, Q3 2025 to Q2 2026)
EV/EBITDA (TTM)	~30.8x (EV ~$1,102bn / TTM EBITDA ~$35.7bn). EBITDA = TTM operating income $33.6bn + TTM D&A $2.1bn, from XBRL. Operating income is after about $2.7bn of acquired IPR&D charges in Q2 2026, so EBITDA before those charges would be higher
P/FCF	~58x. Calculated as market cap ~$1,056bn / TTM FCF ~$18.2bn, where FCF = operating CF $28.1bn − capex $9.9bn (FY2025 less H1 2025 plus H1 2026). On FY2025 FCF alone ($8.97bn) the multiple is ~118x
52-week high	$1,292.65
52-week low	$725.31 (GuruFocus; StockAnalysis shows $716.08)
Short interest (% of float)	0.80% (7.52m shares, settlement date 15 Sep 2026, per MarketBeat)
Days to cover	3.4 (MarketBeat, 15 Sep 2026)
Dividend yield	~0.58% ($6.92 annualised / $1,184.63)

Share-price-based metrics use the 29 Sep 2026 close. For live prices see ChartsView Live Charts.

7. What Are They Building

The next wave of obesity medicines.

Foundayo (orforglipron): the once-daily GLP-1 pill was approved for obesity on 1 Apr 2026. It was filed for type 2 diabetes in Q2 2026, is under review in more than 40 countries, and is targeted for a full global rollout in 2027.
Retatrutide: a GIP/GLP-1/glucagon triple agonist. Lilly says the clinical package is complete for obesity, obstructive sleep apnea and knee osteoarthritis pain, with a US filing planned for Q1 2027. TRIUMPH-2 data released on 29 Sep 2026 showed 20.8% weight loss at 80 weeks in people with obesity and type 2 diabetes.

Manufacturing build-out. Lilly has committed more than $50bn to US manufacturing. Projects include:

Houston, Texas: $6.5bn API plant, groundbreaking 21 Sep 2026;
Huntsville, Alabama: $6bn;
Goochland, Virginia: $5bn;
Lehigh Valley, Pennsylvania: more than $3.5bn;
Indiana: a further $4.5bn;
Europe: a $3bn oral-medicines plant.

Capex was $7.8bn in FY2025 and $5.3bn in H1 2026.

Buying new disease areas. Recent deals include:

Centessa (sleep disorders): about $7.8bn, closed Jun 2026;
Kelonia (in-vivo CAR-T): up to $7bn;
AtaiBeckley (psychedelic-derived psychiatry): closed 11 Sep 2026;
three infectious-disease companies: up to $3.9bn;
Merida Biosciences: up to $2.875bn, pending.

On 28 Sep 2026 David Ricks told Bloomberg he expects somewhat larger deals aimed at new disease areas.

8. Competitive Landscape

Peer	Market cap (Sep 2026)	Key 2025 metric
Johnson & Johnson (JNJ)	~$644.8bn	FY2025 sales $94.2bn, +6.0% (J&J Q4 2025 release)
AbbVie (ABBV)	~$465.3bn	FY2025 net revenue $61.2bn; Skyrizi $17.56bn, Rinvoq $8.30bn (AbbVie FY2025 release)
Merck & Co. (MRK)	~$368.3bn	FY2025 sales $65.0bn, +1%; Keytruda $31.7bn (Merck FY2025 results)
Novo Nordisk (NVO)	~$169.2bn	FY2025 sales DKK 309.1bn, +10% at constant exchange rates; operating profit DKK 127.7bn (Novo FY2025 release on SEC)

Market caps are from companiesmarketcap.com, late Sep 2026. Lilly (~$1,056bn) is the world's largest pharmaceutical company by market value. In US obesity drugs Lilly has about 60% share against about 38% for Novo (Motley Fool, 17 Sep 2026). Novo leads in oral GLP-1 scripts with the Wegovy pill.

9. Leadership and Ownership

David A. Ricks is Chair and CEO, and Lucas Montarce has been EVP and CFO since 2024. The Lilly Endowment is the largest holder with about 91.9m shares (about 9.6% per a 20 Apr 2026 Schedule 13G/A). It sells shares from time to time. Every open-market insider transaction found in 2026 was a sale; there were no purchases. Directors receive small monthly stock-unit awards, which are not shown below.

Name	Date	Type	Shares	Price	Value	Plan Type
Patrik Jonsson (EVP, President LLY International)	17 Aug 2026	Sale	6,500	~$1,175.10	~$7.64m	10b5-1 (adopted 17 Feb 2026)
Donald Zakrowski (SVP Finance, CAO)	10 Aug 2026	Sale	2,000	~$1,185.01	~$2.37m	10b5-1 (adopted 11 May 2026)
Anat Hakim (EVP, General Counsel)	07 Aug 2026	Sale	5,000	$1,190.00	~$5.95m	10b5-1 (adopted 10 Feb 2026)
Ilya Yuffa (EVP, President LLY USA)	10 Jun 2026	Sale	2,500	~$1,151	~$2.88m	10b5-1
Lilly Endowment (holder)	06 May 2026	Sale	15,828	~$995.36	~$15.75m	Not confirmed
Lilly Endowment (holder)	07 Jan 2026	Sale	293,446	$1,085–$1,117	~$322.4m	Not confirmed

Sources: SEC Form 4 filings via EDGAR, secform4.com and StockTitan.

10. Risks and Challenges

Product concentration (Operational): Mounjaro and Zepbound were about 65% of H1 2026 revenue. Any safety signal, supply problem or share loss in tirzepatide would hit the whole company.
Pricing pressure (Regulatory): Realised prices fell 13% worldwide in Q2 2026. The US government agreement fixes $50 Medicare copays and self-pay prices, commercial rebates keep rising, and inclusion in China's NRDL cut outside-US prices by 36%.
Patent expiries (Regulatory): Trulicity loses US compound patent and data protection in 2027, and its sales have already fallen from $7.1bn (2023) to $4.3bn (2025). US data protection for Mounjaro and Zepbound ends in 2027, though the compound patent runs to 2036. Cyramza expires in 2026.
Compounded and illegal copies (Competitive): The 10-K lists illegally compounded products as a risk. On 12 Aug 2026 Lilly filed six lawsuits against sellers of unapproved retatrutide.
Litigation (Legal): Open cases include:
- incretin product-liability suits, consolidated in two federal multidistrict litigations (MDLs) in E.D. Pennsylvania;
- the insulin-pricing MDL;
- 340B contract-pharmacy litigation;
- a Texas Medicaid suit;
- a $90m jury verdict for Nektar on 24 Sep 2026.
Oral GLP-1 competition (Competitive): Novo's Wegovy pill leads Foundayo in prescriptions, and more rival incretins are moving through development.
Deal spending and leverage (Financial): Total debt reached about $54.9bn at 30 Jun 2026 after a run of acquisitions. Acquired IPR&D cost $3.03 per share in Q2 2026 alone, and further deals will add more charges.

11. Recent Developments

29 Sep 2026 — Retatrutide TRIUMPH-2 detail. Retatrutide 12mg gave 20.8% weight loss over 80 weeks in adults with obesity and type 2 diabetes. Separate indirect comparisons favoured Zepbound over Wegovy HD and Foundayo over oral semaglutide.
28 Sep 2026 — CEO signals larger deals. David Ricks told Bloomberg he expects somewhat larger acquisitions aimed at new disease areas.
25 Sep 2026 — Olumiant label expanded. The FDA approved Olumiant for severe alopecia areata in patients aged 12 and over.
24 Sep 2026 — Onswik approved. The FDA approved insulin efsitora alfa, a once-weekly basal insulin for type 2 diabetes.
24 Sep 2026 — Nektar verdict. A jury awarded Nektar $90m against Lilly over the rezpegaldesleukin partnership. Nektar had sought about $1bn, and post-trial motions are possible.
21 Sep 2026 — Houston groundbreaking. Construction began on a $6.5bn API plant for Foundayo, expected to create more than 600 jobs.
18 Sep 2026 — Inluriyo combination approved. The FDA cleared Inluriyo plus Verzenio for ESR1-mutated ER+/HER2- advanced breast cancer.
11 Sep 2026 — AtaiBeckley deal closed. Lilly paid $6.75 cash per share plus a contingent value right (CVR) of up to $2.50.
31 Aug 2026 — Merida Biosciences deal. Lilly agreed to buy Merida for up to $2.875bn, with closing expected in Q4 2026.
28 Aug 2026 — Mounjaro cardiovascular label. The FDA approved Mounjaro to reduce cardiovascular risk in adults with type 2 diabetes.
05 Aug 2026 — Q2 2026 results. Revenue was $22,974m (+48%) and non-GAAP EPS $8.38. Revenue guidance was raised to $85–87bn.

12. Key Dates Coming Up

Expected 29 Oct 2026 — Q3 2026 results. Market calendars and a JPMorgan note give this date; Lilly had not published a confirming release at the time of writing.
Expected Oct 2026 — Q4 2026 dividend declaration. The Q4 2025 dividend was declared on 27 Oct 2025.
14 Nov 2026 — ObesityWeek 2026 opens (14–17 Nov, National Harbor, Washington DC).
Expected Dec 2026 — Merida Biosciences acquisition closes (company guidance: Q4 2026).
Expected Mar 2027 — Retatrutide US submission (company guidance: Q1 2027).

Macro events are on the ChartsView Economic Calendar, and you can discuss Eli Lilly on the ChartsView Forum.

Last Updated: 18 Oct 2026

Gilead Sciences (NASDAQ: GILD) is a US biopharmaceutical company built around HIV medicines, led by Biktarvy for treatment and the Descovy and Yeztugo (twice-yearly lenacapavir) franchise for prevention, with further businesses in liver disease, oncology (Trodelvy and Kite cell therapy) and the antiviral Veklury. In 2026 HIV growth has accelerated and full-year product-sales guidance has been raised twice. At the same time Gilead spent about $11bn on the Arcellx, Tubulis and Ouro deals, which pushed reported Q2 2026 earnings deep into loss and cut its cash pile. 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	GILD / NASDAQ
Headquarters	Foster City, California, USA
CEO / Leadership	Daniel O’Day, Chairman & CEO; Andrew Dickinson, CFO; Johanna Mercier, Chief Commercial & Corporate Affairs Officer
Sector	Healthcare — biopharmaceuticals
Employees	~17,000 at 31 Dec 2025 (FY2025 10-K)
Market cap	~$193.7bn ($156.19 at 16 Oct 2026 close × ~1.240bn shares at 31 Jul 2026)
FY2025 Revenue	$29,443m (+2.4%)
FY2025 GAAP net income	$8,510m ($6.78 per diluted share)
FY2025 non-GAAP EPS	$8.15
2026 guidance	Product sales $30.1–$30.4bn (raised on 04 Aug 2026); GAAP EPS −$3.75 to −$3.40 and non-GAAP EPS −$0.65 to −$0.30, both including ~$9.08 per share of acquired IPR&D charges
Dividend	$0.82 per quarter ($3.28 annualised; yield ~2.1%)

2. Bull & Bear Case

Bull Case

HIV franchise accelerating: HIV sales rose 12% to $5,693m in Q2 2026, with Descovy +48%, and management raised 2026 HIV growth guidance to 9–10% from 8%.
Yeztugo PrEP ramp: Twice-yearly Yeztugo sold $232m in Q2 2026, up 40% on Q1, and Gilead now targets about $1bn of Yeztugo sales in 2026, up from $800m in February.
Long Biktarvy runway: Patent settlements with Lupin, Cipla and Laurus mean no US generic Biktarvy is expected before 01 Apr 2036, and the new Bixlenvo tablet (bictegravir/lenacapavir) was approved on 27 Aug 2026.
Restocked pipeline: The Arcellx deal brings anito-cel, a multiple-myeloma CAR-T with a PDUFA date of 23 Dec 2026, and the Tubulis deal adds an antibody-drug conjugate platform.
Strong cash generation: Free cash flow over the twelve months to 30 Jun 2026 was about $12.9bn, against an annual dividend bill of about $4.1bn.

Bear Case

Biktarvy price negotiation: Biktarvy was selected for Medicare price negotiation in Jan 2026, with a negotiated price effective from 2028 that Gilead expects to be “substantially lower” than today’s.
HIV concentration: HIV produced about 70% of FY2025 revenue, so pricing, policy or competitive pressure in one therapy area moves the whole company.
Balance sheet stretched by deals: Cash fell from $10.6bn at 31 Dec 2025 to about $3.2bn at 30 Jun 2026, total debt rose to about $26.2bn, and stockholders’ equity roughly halved to $11.8bn.
Oncology setbacks: ASCENT-07 missed its primary endpoint, EVOKE-03 in lung cancer was discontinued, cell-therapy sales fell 14% in Q2 2026, and Gilead booked a $1.75bn impairment on Immunomedics assets.
Fading Veklury: Veklury sales fell from $1,799m in FY2024 to $911m in FY2025, and 2026 guidance is about $300m after just $23m in Q2 2026.

3. Business Segments

Gilead operates in a single segment and discloses product sales by therapy area. Percentages use FY2025 total revenue of $29,443m from the Q4 2025 earnings release.

Segment / category	% of revenue	What it is
HIV	70.5% ($20,752m)	Biktarvy ($14,333m) for treatment, Descovy ($2,758m) and Yeztugo for prevention, plus Genvoya, Odefsey and other HIV medicines.
Oncology	11.0% ($3,236m)	Trodelvy ($1,397m), an antibody-drug conjugate for breast cancer, and Kite cell therapies Yescarta ($1,496m) and Tecartus ($343m).
Liver Disease	10.9% ($3,217m)	Hepatitis C (including Epclusa), hepatitis B and Livdelzi (seladelpar) for primary biliary cholangitis.
Veklury	3.1% ($911m)	Remdesivir, the intravenous COVID-19 antiviral; demand follows infection waves.
Other products	2.7% ($799m)	Other marketed medicines outside the four main therapy areas.
Royalty, contract and other	1.8% ($527m)	Royalty and collaboration revenue.

4. Business Model & Moat

How it makes money. Gilead discovers, licenses and acquires patented medicines and sells them to wholesalers, specialty pharmacies, hospitals and governments. The US produced $20,816m, or 72%, of FY2025 product sales. GAAP product gross margin was 78.4% in FY2025, and R&D was $5,799m (19.7% of revenue) before a further $1,024m of acquired IPR&D.

Buying the next growth leg. Gilead has used acquisitions to diversify beyond HIV: Immunomedics (Trodelvy), Kite (cell therapy), Interius (in vivo CAR-T) in 2025, then Arcellx, Tubulis and Ouro Medicines in Apr–Jun 2026. Management has said no further sizeable M&A is planned for 2026.

Moat. Gilead’s strength is a long-lived HIV platform: Biktarvy is protected in the US to 2036 under settlements, and lenacapavir patents run to 2037. Its capsid-inhibitor science supports dosing every six months, with a once-yearly version in trials. That gives it a lead in long-acting HIV prevention, backed by scale in HIV prescribing and payer relationships.

5. Financial Health

Annual figures are from Gilead’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	$27,305m	+10.6%	$4.93	$7.28†	$2.84	$25,179m
FY2022	$27,281m	−0.1%	$3.64	$7.26	$2.92	$22,957m
FY2023	$27,116m	−0.6%	$4.50	$6.72	$3.00	$23,189m
FY2024	$28,754m	+6.0%	$0.38	$4.62	$3.08	$24,896m
FY2025	$29,443m	+2.4%	$6.78	$8.15	$3.16	$22,129m

Adjusted EPS is Gilead’s non-GAAP diluted EPS as reported in each Q4 release. † FY2021 as originally reported; from 2022 Gilead stopped excluding acquired IPR&D from non-GAAP results, and FY2021 was revised to $7.18. FY2024 GAAP operating income fell to $1,662m (SEC XBRL), which depressed EPS that year. 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	$7,803m	−$6.75	−$8.45
Q1 2026	$6,960m	$2.03	$1.61
Q4 2025	$7,925m	$1.86	$1.74
Q3 2025	$7,769m	$2.47	$2.43
FY2025 total	$29,443m	$8.15	$6.78

Q2 2026 includes a $9.08 per share charge for $11.2bn of acquired IPR&D (Arcellx $7.0bn, Tubulis $3.1bn, Ouro $1.0bn) and a $1.75bn IPR&D impairment. Gilead says non-GAAP EPS excluding the deals and a one-off $156m of royalty revenue was $2.27. Q3 2025 revenue included about $400m of one-off IP-sale revenue. Over the four quarters to 30 Jun 2026 revenue was about $30,457m and GAAP EPS about −$2.67.

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

Operating cash flow: $10.02bn in FY2025; ~$13.55bn trailing twelve months to 30 Jun 2026 (H1 2026 $6.12bn against H1 2025 $2.58bn).
Capital expenditure: $0.56bn in FY2025; ~$0.61bn trailing twelve months.
Depreciation & amortisation: $2.76bn in FY2025 (depreciation $0.37bn plus intangible amortisation $2.39bn); ~$2.76bn trailing twelve months.
Debt at 30 Jun 2026: non-current long-term debt $23,832m and current portion $2,414m, $26,246m in total, after $3.0bn of new senior notes and a $1.1bn term loan in Q2 2026.
Cash at 30 Jun 2026: cash, cash equivalents and restricted cash of $3,179m, with no marketable securities, down from $10.6bn of cash and marketable securities at 31 Dec 2025. Stockholders’ equity was $11,829m.

6. Valuation

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

Metric	Value
Market cap	~$193.7bn (price $156.19 at 16 Oct 2026 close × ~1.240bn shares)
Enterprise value	~$216.7bn (market cap ~$193.7bn + total debt ~$26.2bn − cash ~$3.2bn per 30 Jun 2026 balance sheet; total debt = non-current long-term debt $23.83bn + current portion $2.41bn)
Trailing P/E (GAAP)	n/m — TTM GAAP EPS is ~−$2.67 (Q3 2025–Q2 2026) because of the Q2 2026 acquired IPR&D charge; on FY2025 GAAP EPS of $6.78 the multiple is ~23.0x
P/E (forward)	n/m on 2026 non-GAAP EPS guidance of −$0.65 to −$0.30; on Gilead’s illustrative $8.50–$8.85 excluding the deal charges, the multiple is ~18.0x at the $8.675 midpoint
P/S (TTM)	~6.4x ($193.7bn / ~$30.46bn TTM revenue)
EV/EBITDA (TTM)	Distorted: GAAP TTM EBITDA is only ~$0.26bn (operating loss ~$2.50bn + D&A ~$2.76bn) after $11.2bn of acquired IPR&D and a $1.75bn impairment. Adding back those two Q2 2026 charges gives ~$13.2bn and ~16.4x; on FY2025 EBITDA of ~$12.78bn (operating income $10.02bn + D&A $2.76bn) it is ~17.0x
P/FCF	~15.0x (market cap ~$193.7bn / TTM FCF ~$12.94bn; FCF = operating CF $13.55bn − capex $0.61bn); on FY2025 FCF of ~$9.46bn ($10.02bn − $0.56bn) it is ~20.5x
Price/book	~16.4x ($193.7bn / stockholders’ equity $11.8bn at 30 Jun 2026)
Dividend yield	~2.1% ($3.28 annualised / $156.19)
52-week high	$160.51 (15 Oct 2026, intraday)
52-week low	$114.02 (31 Oct 2025, intraday)
Short interest (% of float)	~1.5% (18.3m shares at 15 Sep 2026 settlement, MarketBeat); FINRA data show ~21.8m shares at 30 Sep 2026, ~1.8% of shares outstanding
Days to cover	~3.4–3.7 days

7. What Are They Building

Gilead is extending its HIV lead into longer-acting medicines while building oncology and inflammation businesses through acquisitions.

Long-acting HIV prevention: Yeztugo (twice-yearly lenacapavir) is ramping, with more than 70% of users returning for their six-month injection. A once-weekly oral Yeztugo tablet for PrEP has a PDUFA date of 02 Feb 2027, and once-yearly lenacapavir (PURPOSE 365) has completed enrolment, with an update in 2027 and a potential 2028 launch.
Next-generation HIV treatment: Bixlenvo (bictegravir/lenacapavir) was approved on 27 Aug 2026. Once-weekly islatravir/lenacapavir with Merck posted positive Phase 3 ISLEND-1 and ISLEND-2 results, with filing and potential launch in 2027. A twice-yearly lenacapavir plus two broadly neutralising antibodies regimen is entering Phase 3.
Cell therapy: Anito-cel, acquired with Arcellx on 28 Apr 2026, has a PDUFA date of 23 Dec 2026 in fourth-line-plus multiple myeloma, and the iMMagine-3 second-line trial could support a filing from 2027. Interius adds in vivo CAR-T technology.
Antibody-drug conjugates: Trodelvy won US approval in first-line metastatic TNBC on 24 Jun 2026 and an expanded EU label on 24 Aug 2026; the ASCENT-GYN endometrial update is due in 2026. Tubulis’ lead ADC, GS-8824, showed a 61% confirmed response rate in platinum-resistant ovarian cancer.
Liver and inflammation: Livdelzi sales more than doubled to $167m in Q2 2026 after a positive Phase 3 IDEAL result, and Phase 2 readouts are due in 2026 for GS-1427 (SWIFT) and edecesertib (COSMIC).

8. Competitive Landscape

Gilead competes with GSK’s ViiV Healthcare and Merck in HIV, and with other large-cap biopharma groups in oncology, cell therapy and liver disease. Market caps are mid-Oct 2026 figures. Metrics come from each company’s FY2025 results release.

Peer	Market cap (Oct 2026)	Key 2025 metric
AbbVie (ABBV)	~$504bn	FY2025 net revenues $61,160m, per AbbVie Q4 2025 release
Merck & Co. (MRK)	~$360bn	FY2025 sales ~$65.0bn, including Keytruda $31.7bn, per Merck Q4 2025 release
AstraZeneca (AZN)	~$257bn	FY2025 total revenue ~$58.7bn, per AstraZeneca FY2025 20-F
Amgen (AMGN)	~$234bn	FY2025 revenue ~$36.8bn, per Amgen Q4 2025 release
Vertex (VRTX)	~$127bn	FY2025 revenue ~$12.0bn, per Vertex Q4 2025 release
Bristol Myers Squibb (BMY)	~$122bn	FY2025 revenue ~$48.2bn, per BMS Q4 2025 release
GSK (GSK), owner of ViiV	~$99bn	FY2025 HIV sales £7.7bn (+11%), including Dovato £2.7bn, per GSK FY2025 results
Regeneron (REGN)	~$81bn	FY2025 revenue ~$14.3bn, per Regeneron Q4 2025 release

9. Leadership & Insider Activity

Daniel O’Day is Chairman and CEO, and Andrew Dickinson is CFO. Johanna Mercier is Chief Commercial & Corporate Affairs Officer, Dietmar Berger is Chief Medical Officer, and Cindy Perettie leads Kite. Keeley Cain Wettan became EVP and General Counsel on 18 Dec 2025. No C-suite changes were found for 2026. Form 4 filings show no open-market insider purchases in 2026; all transactions were sales, many after option exercises, and the filings checked state Rule 10b5-1 plans. A selection is below.

Name	Date	Type	Shares	Price	Value	Plan Type
Andrew Dickinson (CFO)	15 Oct 2026	Sale	3,000	$156.22	~$0.47m	Rule 10b5-1 plan adopted 29 Aug 2024 (monthly sales)
Daniel O’Day (Chairman & CEO)	01 Oct 2026	Sale	15,000	~$147.90	~$2.22m	Rule 10b5-1 plan adopted 25 Feb 2026 (monthly sales)
Anthony Welters (Director)	26 Aug 2026	Option exercise and sale	18,000	~$148.62	~$2.68m	Rule 10b5-1 plan adopted 27 May 2026
Jeffrey Bluestone (Director)	20 Aug 2026	Option exercise and sale	5,000	$145.02	~$0.73m	Rule 10b5-1 plan adopted 20 May 2026
Johanna Mercier (Chief Commercial & Corporate Affairs Officer)	17 Aug 2026	Option exercise and sale	28,000	$137.64	~$3.85m	Rule 10b5-1 plan adopted 20 Feb 2025
Daniel O’Day (Chairman & CEO)	05 Feb 2026	Option exercise and sale	115,640	$150.00	~$17.35m	Rule 10b5-1 plan adopted 28 Feb 2025

10. Key Risks

Medicare price negotiation (Regulatory): Biktarvy, Gilead’s largest product at $14.3bn of FY2025 sales, was selected for IRA negotiation on 27 Jan 2026. The negotiation period ends 01 Nov 2026 and the price takes effect from 01 Jan 2028; Gilead expects it to be substantially lower than the current Medicare price.
US pricing and coverage policy (Regulatory): Gilead signed a most-favoured-nation pricing agreement in Dec 2025 that gives Medicaid access to MFN prices, and the expiry of enhanced ACA subsidies slowed HIV treatment market growth in Q2 2026.
Exclusivity losses outside HIV treatment (Commercial): Descovy loses EU protection in 2027, Tecartus its US protection in 2027 and Trodelvy its US protection in 2028, while Veklury and cell-therapy sales are already falling.
Deal and pipeline execution (Operational): About $11bn was spent on Arcellx, Tubulis and Ouro in 2026, and their value depends on the anito-cel approval and launch and on early-stage ADC and inflammation assets. Recent setbacks include ASCENT-07, EVOKE-03 and a $1.75bn impairment.
Leverage after the deal spree (Financial): Cash fell to about $3.2bn at 30 Jun 2026 against $26.2bn of debt, including $2.4bn due within a year, and stockholders’ equity fell to $11.8bn. Debt reduction now competes with the $4.1bn annual dividend.
HIV concentration (Commercial): HIV produced $20.8bn, about 70% of FY2025 revenue, and Biktarvy alone about 49%. Competition from GSK’s ViiV Healthcare, the largest other HIV supplier (FY2025 HIV sales £7.7bn), or a pricing shock in this one therapy area would affect the whole company.

11. Recent Developments

15 Oct 2026 — Q3 date set. Gilead will release Q3 2026 results on Thursday 29 Oct 2026 after the market close, with a webcast at 4:30pm ET. The shares hit a 52-week high of $160.51 the same day.
29 Sep 2026 — Dividend paid. Gilead paid its $0.82 quarterly dividend to holders of record on 15 Sep 2026.
16 Sep 2026 — Once-yearly lenacapavir access planning. Gilead extended its six royalty-free lenacapavir voluntary licences to cover investigational once-yearly lenacapavir in 120 countries.
15 Sep 2026 — PAHO agreement. An agreement with the Pan American Health Organization will widen access to twice-yearly lenacapavir PrEP across Latin America and the Caribbean.
27 Aug 2026 — Bixlenvo approved. The FDA approved Bixlenvo (bictegravir 75mg/lenacapavir 50mg), a once-daily single tablet for virologically suppressed adults with HIV, including people on complex regimens.
24 Aug 2026 — Trodelvy EU label expanded. The European Commission expanded Trodelvy’s first-line metastatic TNBC approval to cover patients regardless of PD-L1 status.
04 Aug 2026 — Q2 2026 results. Revenue rose 10% to $7,803m, and GAAP EPS was −$8.45 and non-GAAP EPS −$6.75 after $11.2bn of acquired IPR&D. Full-year product-sales guidance was raised to $30.1–$30.4bn.
03 Aug 2026 — TDF litigation win. The California Supreme Court ruled for Gilead in the state-court TDF litigation and directed judgment for Gilead on all claims.
24 Jun 2026 — Trodelvy US first-line approval. The FDA approved Trodelvy for first-line metastatic triple-negative breast cancer.
04 Jun 2026 — Ouro deal closed. Gilead completed its Ouro Medicines transaction ($1.675bn upfront, shared equally with Lakefront), after closing Tubulis on 21 May 2026 and Arcellx on 28 Apr 2026.

12. Key Dates

21 Oct 2026 — IDWeek 2026 opens in Washington, DC (to 24 Oct)
29 Oct 2026 — Q3 2026 results after the market close, webcast at 4:30pm ET
01 Nov 2026 — Medicare price negotiation period for Biktarvy ends (CMS third cycle)
05 Nov 2026 — AASLD The Liver Meeting opens in Denver (to 09 Nov)
12 Dec 2026 — ASH annual meeting opens in New Orleans (to 15 Dec)
23 Dec 2026 — FDA PDUFA date for anito-cel in relapsed/refractory multiple myeloma
02 Feb 2027 — FDA PDUFA date for once-weekly oral Yeztugo (lenacapavir 300mg tablets) for PrEP
01 Jan 2028 — Medicare negotiated price for Biktarvy takes effect

The Q4 2026 dividend declaration and its dates have not been announced. Gilead has said the ASCENT-GYN Trodelvy update and the SWIFT and COSMIC Phase 2 readouts are due before the end of 2026, without exact dates.

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Last Updated: 28 Sep 2026

UnitedHealth Group (NYSE: UNH) is the largest US health insurer and one of the largest US healthcare services companies. Its business has two platforms. UnitedHealthcare provides health benefits. Optum covers care delivery (Optum Health), data and technology (Optum Insight) and pharmacy benefit management (Optum Rx).

FY2025 revenue was $447.6bn, but adjusted EPS fell to $16.35 from $27.66 as medical costs ran well above pricing. Stephen Hemsley returned as CEO in May 2025, and 2026 has been a repair year. Q2 2026 adjusted EPS was $6.38 against $4.08 a year earlier, the medical care ratio improved to 86.7%, and in July management raised 2026 adjusted EPS guidance to $19.50–$20.00.

Formal DOJ criminal and civil requests about Medicare Advantage practices remain unresolved. This refresh draws on UnitedHealth press releases, SEC 10-K/10-Q/8-K filings, SEC XBRL company facts and Form 4 filings, all retrieved on 28 Sep 2026. Follow the price on ChartsView Live Charts.

1. Company Snapshot

Field	Value
Full name	UnitedHealth Group Incorporated
Ticker	UNH (NYSE)
Sector	Healthcare & Pharma
Industry	Managed care, health services and pharmacy benefit management
CEO / Leadership	Stephen Hemsley (Chair and CEO since May 2025); Wayne DeVeydt (CFO since Sep 2025); Patrick Conway (CEO, Optum); Tim Noel (CEO, UnitedHealthcare)
Market cap	~$338.4bn (share price $377.02 at the 25 Sep 2026 close)
Revenue (FY2025)	$447,567m (+11.8% YoY), per FY2025 10-K
Net income (FY2025)	$12,056m GAAP attributable to UnitedHealth shareholders
Employees	More than 390,000 at 31 Dec 2025, including nearly 165,000 clinical professionals, per FY2025 10-K
People served	UnitedHealthcare served 48.5m people at 30 Jun 2026
Dividend	$2.32 per quarter ($9.28 annualised) since Jun 2026

2. Bull Case vs Bear Case

Distilled from the full report below. Factual only, no ratings.

Bull Case

Earnings recovery under way: Q2 2026 adjusted EPS was $6.38 against $4.08 in Q2 2025. The 2026 adjusted EPS guide was raised twice, from more than $17.75 in January to $19.50–$20.00 in July.
Medical cost ratio back under control: The medical care ratio improved to 86.7% in Q2 2026 from 89.4% a year earlier. UnitedHealthcare's operating earnings rose to $3,942m from $2,075m.
High-margin Optum businesses: Optum Insight earned a 25.3% operating margin in Q2 2026 and Optum Rx earned $1,490m. Management targets a 6–8% Optum Health margin by 2028.
Cash generation and capital return: H1 2026 operating cash flow was $19,964m against capex of $1,562m. Management plans at least $5bn of buybacks in 2026, and the quarterly dividend is $2.32.

Bear Case

Unresolved federal investigations: UNH is complying with formal DOJ criminal and civil requests about its Medicare Advantage practices, first disclosed on 24 Jul 2025. A Senate report in January 2026 criticised its coding practices, and an HHS-OIG audit on 17 Sep 2026 found estimated overpayments of $46.9m.
Lower-quality earnings mix in Q2: The 86.7% medical care ratio included $860m of favourable prior-period reserve development. Full-year 2026 guidance is for 88.1% ± 25bp.
Optum Health reset: Optum Health revenue fell 5% in Q2 2026 as about 700k fewer patients were served under value-based care. Management guides to a margin of about 2% in 2026.
Government-funding dependence: Medicare, Medicaid and ACA funding rules, Star ratings and RADV coding audits directly drive revenue. Management expects Medicaid margins, near −1.1%, to trough in 2026.

3. What Does This Company Actually Do?

UnitedHealthcare sells health benefits in four markets:

employer-sponsored plans;
individual plans;
Medicare Advantage and other Medicare products;
Medicaid plans run on contract for states.

Optum sells services to UnitedHealthcare and to outside payers, employers, providers and government. Optum Health runs clinics, physician groups, home health (including Amedisys, acquired August 2025) and value-based care arrangements. Optum Insight provides data, analytics, software and revenue-cycle services, including Change Healthcare's claims network. Optum Rx is a pharmacy benefit manager and pharmacy operator.

Segment	% of revenue	What it is
UnitedHealthcare	55.5% of gross segment revenue ($344,903m FY2025)	Health benefits. FY2025 revenue by market: Employer & Individual $79.2bn, Medicare & Retirement $171.3bn, Community & State (Medicaid) $94.4bn
Optum Rx	24.9% ($154,726m)	Pharmacy benefit management and pharmacy services. 1.66bn adjusted scripts in FY2025
Optum Health	16.4% ($101,957m)	Care delivery: clinics, physician groups, home and community care, value-based care
Optum Insight	3.1% ($19,417m)	Data, analytics, software and revenue-cycle technology, including Change Healthcare

Shares are of gross segment revenue of $621,003m, before inter-segment and corporate eliminations of $173,436m that reconcile to consolidated revenue of $447,567m. From 1 Jan 2026, Optum Financial moved from Optum Health to Optum Insight; on that basis FY2025 revenue was $100,051m for Optum Health and $21,034m for Optum Insight. Source: Q4 2025 earnings release (SEC 8-K, 27 Jan 2026) and Q1 2026 release.

4. The Business Model

How it makes money. Risk-based premiums are close to 80% of revenue, per the 10-K. UnitedHealthcare collects fixed premiums from employers, individuals and government programmes and pays members' medical and pharmacy claims. Its margin is the gap between premiums and medical costs (the medical care ratio) less operating costs. Optum earns fees, capitated payments and product revenue, much of it from UnitedHealthcare and the rest from outside clients.

Where the moat sits. The moat is scale and vertical integration. UnitedHealthcare's 48.5m members give it bargaining power with providers and a large data set. Optum's claims network, analytics and PBM purchasing volumes serve the insurer and outside clients alike. There are also high regulatory and capital barriers to entry in Medicare Advantage and Medicaid. The same integration draws regulatory scrutiny, including DOJ conditions on the Amedisys deal and the investigations described in Section 10.

What changed in 2025–2026. Medical cost trend ran well ahead of pricing in 2025, especially in Medicare Advantage. FY2025 adjusted EPS fell to $16.35 from $27.66, and Q4 2025 included a $1.6bn after-tax charge ($1.78 per share) for restructuring, cyberattack costs and portfolio actions.

Management's repair plan has five parts:

2026 repricing;
exits from unprofitable markets, such as the Louisiana Medicaid plan;
right-sizing Optum Health's value-based care book;
a transparent, fee-based Optum Rx model with 100% rebate pass-through by 1 Jan 2028;
a multi-billion-dollar AI and automation cost programme.

5. Financial Health

Sources: UnitedHealth quarterly and annual earnings releases (SEC 8-K), the FY2025 Form 10-K, and SEC XBRL company facts (data.sec.gov) for debt, cash flow, D&A and operating income.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$287,597m	+11.8%	$18.08	$19.02	$5.60	$42,383m
FY2022	$324,162m	+12.7%	$21.18	$22.19	$6.40	$54,513m
FY2023	$371,622m	+14.6%	$23.86	$25.12	$7.29	$58,263m
FY2024	$400,278m	+7.7%	$15.51†	$27.66	$8.18	$72,359m
FY2025	$447,567m	+11.8%	$13.23†	$16.35	$8.73	$72,320m

† FY2024 GAAP EPS includes an ~$8.3bn loss, mainly on the sale of the Brazil operations. FY2025 GAAP EPS includes a $1.78 per share Q4 charge covering restructuring, cyberattack costs and portfolio actions. Dividend/share is the calendar-year sum of quarterly payments. Long-term debt is the noncurrent portion at year-end. Current debt was a further $6,069m at FY2025 year-end.

Quarterly results (most recent first)

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026	$112,032m	$6.38	$6.04
Q1 2026	$111,721m	$7.23	$6.90
Q4 2025	$113,215m	$2.11	$0.01
Q3 2025	$113,161m	$2.92	$2.59
Q2 2025	$111,616m	$4.08	$3.74
Q1 2025	$109,575m	$7.20	$6.85
FY2025 total	$447,567m	$16.35	$13.23

Cash flow and balance sheet.

Cash flow.
- FY2025 operating cash flow was $19,697m and capital expenditure was $3,622m, giving free cash flow of $16,075m.
- FY2025 depreciation and amortisation was $4,361m, and operating income was $18,964m.
- For H1 2026, operating cash flow was $19,964m, capex $1,562m and operating income $16,981m.
Balance sheet at 30 Jun 2026.
- Cash and cash equivalents were $28,585m and short-term investments $2,883m.
- Current debt was $3,827m and long-term debt $69,501m.
- Debt-to-capital was 41.2%, and management targets about 40% by Q4.
2026 guidance (updated 16 Jul 2026): GAAP EPS $18.45–$18.95, adjusted EPS $19.50–$20.00, operating earnings above $25.45bn, operating cash flow about $24bn and capex about $3.8bn.

6. Valuation & Market Data

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

Metric	Value
Market cap	~$338.4bn (share price $377.02 at the 25 Sep 2026 close, per MarketBeat)
Enterprise value	~$380.3bn. Calculated as market cap ~$338.4bn + total debt ~$73.3bn (current debt $3.8bn + long-term debt $69.5bn) − cash and short-term investments ~$31.5bn, per the 30 Jun 2026 10-Q balance sheet. Long-term investment portfolios held against insurance liabilities are not deducted.
Trailing P/E (GAAP)	~24.2x. Calculated as $377.02 / TTM GAAP diluted EPS of $15.56 (FY2025 $13.23 − H1 2025 $10.61 + H1 2026 $12.94). On TTM adjusted EPS of $18.64 (Q3 2025 to Q2 2026) the multiple is ~20.2x.
P/E (forward)	~19.1x ($377.02 / 2026 adjusted EPS guidance midpoint of $19.75)
P/S (TTM)	~0.75x. Calculated as market cap / TTM revenue of $450.1bn (FY2025 $447.6bn − H1 2025 $221.2bn + H1 2026 $223.8bn)
EV/EBITDA (TTM)	~14.6x (EV ~$380.3bn / EBITDA ~$26.0bn). EBITDA = TTM operating income $21.7bn + TTM depreciation and amortisation $4.3bn. The TTM window includes the Q4 2025 restructuring, cyberattack and portfolio charges.
P/FCF	~21.1x. Calculated as market cap ~$338.4bn / FY2025 FCF ~$16.1bn, where FCF = operating CF $19.70bn − capex $3.62bn per the FY2025 cash flow statement. On TTM FCF of ~$23.6bn the multiple is ~14.3x; operating cash flow can swing with the timing of CMS payments.
52-week high	$461.62
52-week low	$255.96
Short interest (% of float)	1.48% (13.22m shares, settlement date 15 Sep 2026, per MarketBeat; 1.7% at 31 Aug 2026)
Days to cover	2.47 (MarketBeat, 15 Sep 2026)
Dividend yield	~2.5% ($9.28 annualised / $377.02)

Share-price-based metrics use the 25 Sep 2026 close. For live prices see ChartsView Live Charts.

7. What Are They Building

AI and automation. The Q2 2026 release says targeted investments in infrastructure, AI and care delivery drove an operating cost ratio of 12.7%. Specific initiatives include:

Optum Insight products for autonomous coding and digital prior authorisation;
a UnitedHealthcare AI Companion for members, launched 26 Mar 2026;
full automation of Optum's finance function by the end of 2027, as described at the Wells Fargo healthcare conference on 9 Sep 2026.

Resetting Optum Health. Optum Health is shrinking its value-based care book, serving about 700k fewer patients, and expects around 4.1m fully accountable patients in 2026. It targets a 6–8% margin by 2028, from about 2% in 2026 and about 4% in 2027. In September 2026 it sold an interest in some Florida WellMed clinics to TPG.

Pharmacy model changes. On 11 May 2026 Optum Rx announced a transparent, fee-based model with no spread pricing, and it has committed to 100% rebate pass-through by 1 Jan 2028.

Prior authorisation reform. UnitedHealthcare aims to cut prior-authorisation volume by 30% by the end of 2026. About 1,700 codes come off prior authorisation from 1 Oct 2026.

Portfolio. Recent moves:

The Alegeus acquisition (consumer-directed accounts) closed on 2 Jul 2026.
The Optum UK sale completed in Q1 2026.
The about $1bn sale of Banmedica (South America) to Patria is expected to close in H2 2026.

Management has said it will re-engage in M&A in value-based care and Optum Insight. Capex is guided at about $3.8bn for 2026.

8. Competitive Landscape

Peer	Market cap (Sep 2026)	Key 2025 metric
CVS Health (CVS)	~$114.0bn	FY2025 revenue $402.1bn, +7.8%; adjusted EPS $6.75 (CVS FY2025 release)
Elevance Health (ELV)	~$85.9bn	FY2025 operating revenue $197.6bn, +13%; adjusted EPS $30.29 (Elevance Q4 2025 release)
Cigna Group (CI)	~$72.3bn	FY2025 revenue $274.9bn, +11%; adjusted EPS $29.84 (Cigna FY2025 release)
Humana (HUM)	~$47.7bn	FY2025 revenue $129,664m; adjusted EPS $17.14, GAAP EPS $9.84 (Humana Q4 2025 release)
Centene (CNC)	~$30.8bn	FY2025 revenue $194,777m; GAAP EPS −$13.53, adjusted EPS $2.08 (Centene FY2025 release)

Market caps are from MarketBeat quote pages, 22–25 Sep 2026.

Where UnitedHealth competes with each peer:

Medicare Advantage: mainly Humana, CVS (Aetna) and Elevance.
Medicaid: Centene, Elevance and Molina.
Pharmacy benefit management: Optum Rx against CVS Caremark and Cigna's Express Scripts.
Care delivery: large health systems, physician groups and retailer-owned clinic chains.

9. Leadership and Ownership

Stephen Hemsley returned as Chair and CEO on 13 May 2025, replacing Andrew Witty. Other management changes:

Wayne DeVeydt (Elevance CFO from 2007 to 2016) became CFO on 2 Sep 2025.
About half of the top-100 leadership roles have been refreshed.
Jodee Kozlak became Chief Administrative Officer from 28 Sep 2026.

The board added a Public Responsibility Committee and a Lead Independent Director, and Scott Gottlieb joined on 18 Nov 2025. Hemsley held 1,055,339 shares directly as of 22 Sep 2026. Berkshire Hathaway, which disclosed a stake in August 2025, had sold it entirely by Q1 2026.

Name	Date	Type	Shares	Price	Value	Plan Type
Wayne DeVeydt (CFO)	02 Sep 2026	Shares withheld for tax	1,209	$399.66	~$0.48m	Tax withholding, not a market trade
Patrick Conway (CEO, Optum)	21 Aug 2026	Open-market sale	1,169	$390.00	$455,910	Not marked 10b5-1 on Form 4
Patrick Conway (CEO, Optum)	05 Aug 2026	Sale	500	$410.00	$205,000	Not confirmed
Patrick Conway (CEO, Optum)	23 Apr 2026	Sale	800	$355.00	$284,000	Not confirmed
Stephen Hemsley (Chair and CEO)	16 May 2025	Open-market purchase	86,700	$288.57 (avg)	~$25.0m	Discretionary purchase
John Rex (then CFO)	16 May 2025	Open-market purchase	17,200	$291.12	~$5.0m	Discretionary purchase
Kristen Gil (Director)	15 May 2025	Open-market purchase	3,700	$271.17	~$1.0m	Discretionary purchase
Timothy Flynn (Director)	14 May 2025	Open-market purchase	1,533	$320.80	~$0.49m	Discretionary purchase

Sources: SEC Form 4 filings (via secform4.com and EDGAR) and contemporaneous reporting of the May 2025 purchases. No open-market insider purchases were found in 2026.

10. Risks and Challenges

Government investigations (Legal/Regulatory): DOJ criminal and civil requests about Medicare Advantage practices remain open. Reports say the criminal probe also covers Optum Rx billing and physician pay. Under the False Claims Act, penalties and possible programme exclusion are among the stated risks.
Medical cost trend (Financial): Risk-based premiums are close to 80% of revenue, so misjudging utilisation, costs or reserves feeds straight into earnings, as happened in 2025.
Government funding and coding audits (Regulatory): Revenue depends on Medicare Advantage benchmarks and risk-adjustment rules, Star ratings (four or more stars earn quality bonuses), Medicaid redeterminations, ACA subsidies and RADV recoupments. The 17 Sep 2026 HHS-OIG audit is a live example.
PBM reform (Regulatory): Legislative or regulatory changes to pharmacy benefit management could hit Optum Rx economics while the business moves to a transparent pass-through model.
Cyber and data (Operational): The 2024 Change Healthcare cyberattack cost a further $799m in Q4 2025. UNH holds sensitive health data for a large share of the US population.
Execution on the turnaround (Operational): Delivering the Optum Health margin reset, the AI cost programme and market exits while keeping members and providers happy is a multi-year task under new leadership.

11. Recent Developments

24 Sep 2026 — New Chief Administrative Officer. UNH named Jodee Kozlak Chief Administrative Officer, effective 28 Sep 2026.
17 Sep 2026 — HHS-OIG audit of UnitedHealthcare of Wisconsin. The audit estimated $46.9m of Medicare Advantage overpayments for 2020–21 based on unsupported diagnosis codes. UnitedHealthcare disputes the methodology.
15 Sep 2026 — Q3 date set. UNH will report Q3 2026 results on 13 Oct 2026.
09 Sep 2026 — Wells Fargo healthcare conference. Management said:
- Medicare Advantage margins are tracking in the upper half of the 2–4% range.
- Medicaid margins, near −1.1%, should trough in 2026.
- Optum Health is targeting a 6–8% margin by 2028.
- Buybacks will be at least $5bn.
08 Sep 2026 — TPG invests in Florida WellMed clinics. Optum sold an interest in some Florida WellMed clinics to TPG on undisclosed terms. The shares fell about 3% on 9 Sep.
01 Sep 2026 — Prior authorisation cut. UnitedHealthcare said about 1,700 codes will no longer need prior authorisation from 1 Oct 2026.
12 Aug 2026 — Dividend declared. The board declared a $2.32 per share quarterly dividend, paid 22 Sep 2026.
16 Jul 2026 — Q2 2026 results and guidance raised.
- Revenue was $112,032m, GAAP EPS $6.04 and adjusted EPS $6.38.
- The medical care ratio was 86.7%, including $860m of favourable prior-period development.
- 2026 adjusted EPS guidance was raised to $19.50–$20.00.

12. Key Dates Coming Up

01 Oct 2026 — About 1,700 codes come off UnitedHealthcare's prior-authorisation list.
Expected Oct 2026 — CMS publishes 2027 Medicare Advantage Star ratings. The exact date has not been confirmed.
13 Oct 2026 — Q3 2026 results before the market open, with the conference call at 8:00am ET. The replay is available until 27 Oct 2026.
15 Oct 2026 — The Medicare Annual Enrollment Period opens.
Expected H2 2026 — Closing of the Banmedica (South America) sale to Patria.
TBC — Next dividend declaration. UNH typically announces dividends in Feb, Jun, Aug and Nov.

Macro events are on the ChartsView Economic Calendar, and you can discuss UnitedHealth on the ChartsView Forum.

Last Updated: 28 Sep 2026

Johnson & Johnson (NYSE: JNJ) is a diversified healthcare company that has operated as two segments, Innovative Medicine and MedTech, since it separated its consumer business (Kenvue) in 2023. FY2025 sales were $94.2bn, and in July 2026 management raised full-year 2026 guidance for the second time, to reported sales of $100.8–101.4bn and adjusted EPS of $11.60–11.75. The company is managing the loss of exclusivity on Stelara, growing Darzalex, Tremfya and Carvykti, and preparing to separate its orthopaedics business (DePuy Synthes). In July 2026 it also proposed a $5.5bn resolution of the remaining ovarian talc claims. This refresh draws on J&J press releases, SEC 10-K/10-Q/8-K filings, SEC XBRL company facts and Form 4 filings, all retrieved on 28 Sep 2026. Follow the price on ChartsView Live Charts.

1. Company Snapshot

Field	Value
Full name	Johnson & Johnson
Ticker	JNJ (NYSE)
Sector	Healthcare & Pharma
Industry	Pharmaceuticals and medical devices
Incorporated	New Jersey, 1887 (per FY2025 10-K)
CEO / Leadership	Joaquin Duato (Chairman and CEO); Joseph Wolk (EVP, CFO); Tom Cavanaugh succeeded Jennifer Taubert as head of Innovative Medicine from September 2026
Market cap	~$653.6bn (share price $271.22 at the 25 Sep 2026 close)
Revenue (FY2025)	$94,193m (+6.0% YoY), per FY2025 10-K
Net income (FY2025)	$26,804m GAAP, lifted by a ~$6.9bn talc reserve reversal in Q1 2025 (see Section 5)
Employees	~140,800 at 28 Dec 2025 (~138,200 full-time equivalents), per FY2025 10-K
Dividend	$1.34 per quarter ($5.36 annualised)
Fiscal year end	Sunday closest to 31 December (FY2025 ended 28 Dec 2025)

2. Bull Case vs Bear Case

Distilled from the full report below. Factual only, no ratings.

Bull Case

Guidance raised twice in 2026: The 2026 reported-sales midpoint has moved from $100.5bn (January) to $101.1bn (July), and the adjusted EPS midpoint from $11.53 to $11.68. Q2 2026 sales rose 6.6% to $25,310m and adjusted EPS rose 4.7% to $2.90.
Growth brands are outrunning Stelara's decline: In Q2 2026, Darzalex grew 18.9% to $4,207m, Tremfya 72.5% to $2,046m, Carvykti 49.4% to $657m and Caplyta 70.9% to $361m. Innovative Medicine still grew 7.8% despite a 55.2% fall in Stelara.
Path to closing out talc: On 27 Jul 2026 J&J proposed a $5.5bn resolution of about 76,000 remaining ovarian talc claims. No more than $3bn is payable in 2027 and nothing further before 2028. The company says about 95% of filed mesothelioma suits are already settled.
Regulatory approvals are coming through: Recent approvals include ICOTYDE (oral icotrokinra, FDA 18 Mar 2026), OTTAVA robotic system (FDA De Novo, 22 Jul 2026) and IMAAVY for wAIHA (FDA, 24 Aug 2026). CAPLYTA's Phase 3 in bipolar mania met its primary endpoint on 21 Sep 2026.
Cash generation and dividend record: FY2025 operating cash flow was $24,530m against capex of $4,832m. Dividends paid per share have risen every year in the table below, from $4.19 in FY2021 to $5.14 in FY2025.

Bear Case

Price pressure on mature brands: Stelara sales fell 41.3% in FY2025 to $6,078m. Xarelto, Stelara and Imbruvica are under Medicare negotiated prices from 2026 and Erleada is on the 2028 list. J&J's January 2026 agreement with the US government commits it to most-favoured-nation pricing.
Talc resolution is not yet done: The $5.5bn proposal needs at least 95% of ovarian claimants to participate. Trials are still producing verdicts, for example a $10m mesothelioma verdict in Louisiana on 24 Aug 2026. J&J's earlier bankruptcy route (Red River Talc) was dismissed on 31 Mar 2025.
Concentration in one drug: Darzalex was about 15% of FY2025 sales and its US patents expire in 2029. J&J pays Genmab royalties of 12–20% on Darzalex sales (about $2.4bn in 2025).
Higher debt and separation execution: Long-term debt (noncurrent) rose from $30,651m at FY2024 year-end to $39,438m at FY2025 year-end after the Intra-Cellular and Halda deals. The orthopaedics separation cost $377m pre-tax in H1 2026, and whether it will be a spin-off or a sale is still open.

3. What Does This Company Actually Do?

J&J discovers, develops, makes and sells prescription medicines and medical devices. Innovative Medicine covers oncology, immunology, neuroscience, pulmonary hypertension, infectious diseases and cardiovascular/metabolism. MedTech has four franchises: Cardiovascular (electrophysiology, Abiomed heart pumps, Shockwave intravascular lithotripsy, neurovascular), Orthopaedics (DePuy Synthes), Surgery (including Ethicon and Mentor) and Vision (ACUVUE contact lenses, TECNIS intraocular lenses). Customers are wholesalers, hospitals, health systems, pharmacies and government purchasers. Per the 10-K, about 43% of sales are made outside the US.

Segment	% of revenue	What it is
Innovative Medicine	64.1% ($60,401m FY2025, +6.0%)	Prescription drugs. FY2025 franchise sales: Oncology $25,380m (Darzalex $14,351m, Carvykti $1,887m, Erleada, Rybrevant, Tecvayli, Talvey), Immunology $15,728m (Stelara $6,078m, Tremfya $5,155m), Neuroscience $7,837m (Spravato $1,696m, Caplyta $700m), Pulmonary Hypertension $4,437m
MedTech	35.9% ($33,792m FY2025, +6.1%)	Medical devices in four franchises. In Q2 2026: Cardiovascular $2,404m (electrophysiology $1,533m, Abiomed $440m, Shockwave $335m), Surgery $2,653m, Orthopaedics $2,418m, Vision $1,451m

Segment figures are from the Q4 2025 earnings release and its sales exhibit (SEC 8-K, January 2026). MedTech franchise figures are for Q2 2026, per the Q2 2026 sales exhibit.

4. The Business Model

How it makes money. In Innovative Medicine, J&J earns revenue from patented medicines, net of rebates, chargebacks and government pricing programmes. These products carry high gross margins while their patents last. In MedTech, revenue comes from devices and consumables used in procedures, so it follows surgical volumes, hospital capital budgets and the installed base of systems such as electrophysiology mapping and Abiomed pumps.

Where the moat sits. In pharma, the moat is patents and regulatory exclusivity, backed by very large late-stage development capacity. R&D expense was $14,665m in FY2025 (15.6% of sales). In MedTech, it is surgeon training and preference, long hospital contracts and a broad catalogue. Scale also matters: the 10-K lists 63 manufacturing plants.

Capital allocation. Management is using acquisitions to replace revenue lost to patent expiries. Recent deals include Intra-Cellular Therapies (closed 2 Apr 2025), Halda Therapeutics ($3.05bn, closed 29 Dec 2025) and Firefly Bio ($1bn, closed 29 Jul 2026). It has also committed more than $55bn to US manufacturing, R&D and technology over the four years to 2029. The quarterly dividend is $1.34 per share.

Policy exposure. The Inflation Reduction Act sets Medicare prices for selected drugs. J&J's January 2026 agreement with the US administration traded most-favoured-nation pricing and TrumpRx participation for tariff relief. Both affect how much revenue each prescription generates in the US.

5. Financial Health

Sources: FY2025 and FY2023 Form 10-K income statements (SEC XBRL R5/R9), J&J quarterly earnings releases filed on Form 8-K, and SEC XBRL company facts (data.sec.gov) for debt, cash flow and D&A. All figures are for continuing operations, excluding Kenvue.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$78,740m	n/a‡	$6.66	n/a‡	$4.19	$29,985m
FY2022	$79,990m	+1.6%	$6.14	$8.93	$4.45	$26,886m
FY2023	$85,159m	+6.5%	$5.20	$9.92	$4.70	$25,881m
FY2024	$88,821m	+4.3%	$5.79	$9.98	$4.91	$30,651m
FY2025	$94,193m	+6.0%	$11.03†	$10.79	$5.14	$39,438m

† FY2025 GAAP EPS includes other income of $7,209m, mostly a ~$6.9bn talc reserve reversal in Q1 2025. ‡ FY2021 figures are the continuing-operations restatement in the FY2023 10-K. J&J has not restated FY2020 or FY2021 adjusted EPS on that basis, so no YoY figure or adjusted EPS is shown for FY2021; as originally reported including Consumer, FY2021 sales were $93.8bn and adjusted EPS was $9.80. Dividend/share is cash dividends paid per share. Long-term debt is the noncurrent portion at year-end. Short-term borrowings, including the current portion of long-term debt, were a further $8,495m at FY2025 year-end.

Quarterly results (most recent first)

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026	$25,310m (+6.6%)	$2.90	$2.27
Q1 2026	$24,062m (+9.9%)	$2.70	$2.14
Q4 2025	$24,564m (+9.1%)	$2.46	$2.10
Q3 2025	$23,993m (+6.8%)	$2.80	$2.12
Q2 2025	$23,743m	$2.77	$2.29
Q1 2025	$21,893m	$2.77	$4.54
FY2025 total	$94,193m	$10.79	$11.03

Q4 2025 GAAP and adjusted EPS both include a $0.10 charge for the Halda acquisition.

Cash flow and balance sheet.

FY2025 operating cash flow was $24,530m and capital expenditure was $4,832m, giving free cash flow of $19,698m.
FY2025 depreciation and amortisation was $7,503m.
For H1 2026, operating cash flow was $11,130m and capex $2,370m.
At 28 Jun 2026, cash and cash equivalents were $20,422m and current marketable securities $336m.
Against that, short-term borrowings were $11,692m and long-term debt $37,344m.
Shareholders' equity was $84,971m.
R&D expense was $14,665m in FY2025 and $7,180m in H1 2026.

6. Valuation & Market Data

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

Metric	Value
Market cap	~$653.6bn (share price $271.22 at the 25 Sep 2026 close, per stockanalysis.com and companiesmarketcap)
Enterprise value	~$681.9bn. Calculated as market cap ~$653.6bn + total debt ~$49.0bn (short-term borrowings $11.7bn + long-term debt $37.3bn) − cash and current marketable securities ~$20.8bn, per the 28 Jun 2026 10-Q balance sheet
Trailing P/E (GAAP)	~31.5x. Calculated as $271.22 / TTM GAAP diluted EPS of $8.62 (FY2025 $11.03 − H1 2025 $6.82 + H1 2026 $4.41). On TTM adjusted EPS of $10.86 (Q3 2025 to Q2 2026) the multiple is ~25.0x.
P/E (forward)	~23.2x ($271.22 / 2026 adjusted EPS guidance midpoint of $11.68)
P/S (TTM)	~6.7x. Calculated as market cap / TTM revenue of $97.9bn (FY2025 $94.2bn − H1 2025 $45.6bn + H1 2026 $49.4bn)
EV/EBITDA (TTM)	~20.1x (EV ~$681.9bn / EBITDA ~$34.0bn). J&J does not report an operating income line, so EBITDA is calculated as: TTM pre-tax income $25.2bn + interest expense $1.0bn + depreciation and amortisation $7.75bn (cash flow statement total). Interest income is not netted out. The TTM window excludes the Q1 2025 talc reserve reversal but includes separation, litigation and in-process R&D charges.
P/FCF	~33.2x. Calculated as market cap ~$653.6bn / FY2025 FCF ~$19.7bn, where FCF = operating CF $24.53bn − capex $4.83bn per the FY2025 cash flow statement. On TTM FCF of ~$22.2bn the multiple is ~29.4x.
52-week high	$281.07
52-week low	$175.91 (one other source shows $177.32)
Short interest (% of float)	0.88% (21.19m shares, settlement date 15 Sep 2026, per MarketBeat)
Days to cover	3.7 (MarketBeat; stockanalysis.com shows 3.42)
Dividend yield	~2.0% ($5.36 annualised / $271.22)

Share-price-based metrics use the 25 Sep 2026 close. For live prices see ChartsView Live Charts.

7. What Are They Building

Immunology after Stelara.

TREMFYA is growing quickly, with Q2 2026 sales of $2,046m. It gained a structural-damage label in psoriatic arthritis in Q2 2026 and met its primary endpoint in an axial PsA study on 25 Sep 2026.
ICOTYDE (icotrokinra), an oral IL-23 receptor peptide, was FDA-approved for plaque psoriasis on 18 Mar 2026 and approved in China on 27 Aug 2026. It is also in ulcerative colitis trials.
IMAAVY (nipocalimab) is approved in generalised myasthenia gravis and, since 24 Aug 2026, in warm autoimmune hemolytic anemia. Phase 2 work continues in lupus and Sjögren's.

Oncology.

Multiple myeloma: DARZALEX, CARVYKTI, TECVAYLI and TALVEY. TECVAYLI plus DARZALEX FASPRO was approved in Q1 2026 for patients as early as second line. On 25 Sep 2026 J&J reported that half of early-line CARVYKTI patients were in treatment-free remission at five years.
Lung cancer: RYBREVANT FASPRO (subcutaneous amivantamab) with LAZCLUZE. At WCLC on 14 Sep 2026, RYBREVANT plus chemotherapy showed the longest median overall survival reported in EGFR exon 20 lung cancer.
Bladder cancer: INLEXZO (TAR-200) was approved in Q3 2025.
Newer platforms: Halda's HLD-0915 and Firefly Bio's degrader-antibody conjugates.

Neuroscience. SPRAVATO sales grew 40.8% in Q2 2026. CAPLYTA gained an MDD adjunctive approval in Q4 2025 and a schizophrenia relapse-prevention approval in Q2 2026. Its bipolar mania Phase 3 was positive on 21 Sep 2026.

MedTech. The OTTAVA soft-tissue surgical robot received FDA De Novo authorisation for upper-abdominal general surgery on 22 Jul 2026. The Cardiovascular franchise (electrophysiology, Abiomed, Shockwave) is MedTech's largest growth engine. Management plans to separate Orthopaedics (DePuy Synthes, about $9.3bn of sales) and says a mid-2027 timeline is intact. On 11 Sep 2026, Bloomberg reported talks with Apollo about a sale for close to $20bn.

Manufacturing. The more-than-$55bn US commitment includes a $2bn+ biologics plant in Wilson, North Carolina and a $1bn+ cell therapy site in Pennsylvania. A new supply-chain restructuring programme costing $650–750m runs to 2029.

8. Competitive Landscape

Peer	Market cap (Sep 2026)	Key 2025 metric
Eli Lilly (LLY)	~$1.06tn	FY2025 revenue $65.2bn, +45% (Lilly Q4 2025 release)
AbbVie (ABBV)	~$467bn	FY2025 net revenue $61.16bn, +8.6% (AbbVie FY2025 release)
Merck & Co. (MRK)	~$367bn	FY2025 sales $65.0bn, +1%; Keytruda $31.7bn (Merck FY2025 release)
Roche (ROG)	~$360bn	FY2025 group sales CHF 61.5bn, +7% at constant exchange rates (Roche FY2025 release)
Novartis (NVS)	~$276bn	FY2025 net sales $54.5bn, +8% (Novartis FY2025 release)
Pfizer (PFE)	~$163bn	FY2025 revenue $62.6bn, −2% (Pfizer FY2025 release)
Medtronic (MDT)	~$113bn	FY ended 24 Apr 2026 revenue $36.4bn, +8.4% (Medtronic FY2026 release)

Market caps are from companiesmarketcap.com, about 25–26 Sep 2026.

J&J competes with a different set of companies in each business:

Multiple myeloma: Bristol Myers Squibb, Pfizer and others.
Immunology: AbbVie (Skyrizi, Rinvoq) and Lilly, plus biosimilar makers taking Stelara volume.
MedTech: Medtronic, Boston Scientific (electrophysiology), Stryker and Zimmer Biomet (orthopaedics), and Intuitive Surgical (robotics).

9. Leadership and Ownership

Joaquin Duato is Chairman and CEO. Joseph Wolk is CFO. Jennifer Taubert, EVP and head of Innovative Medicine, is retiring and was succeeded by Tom Cavanaugh from September 2026 (announced 4 Aug 2026; Cavanaugh filed a Form 3 on 1 Sep 2026). Recent Form 4 filings show option exercises and sales by senior executives. No open-market insider purchases were found in 2026.

Name	Date	Type	Shares	Price	Value	Plan Type
T. Schmid (EVP, MedTech)	02 Sep 2026	Option exercise and sale	33,597	$274.74	~$9.23m	Not marked 10b5-1 on Form 4
Jennifer Taubert (EVP, Innovative Medicine)	17 Aug 2026	Option exercise and sale	15,000	$263.36	~$3.95m	Not marked 10b5-1 on Form 4
Joaquin Duato (Chairman and CEO)	13 Aug 2026	Option exercise and sale	123,291	~$261–262	~$32.2m	Not marked 10b5-1 on Form 4
E. Forminard (EVP, Chief Legal Officer)	06 Aug 2026	Option exercise and sale	15,918	~$256–258	~$4.09m	Not marked 10b5-1 on Form 4
Joaquin Duato (Chairman and CEO)	05 Aug 2026	Sale	48,480	~$258.1–258.7	~$12.5m	Not marked 10b5-1 on Form 4
Joseph Wolk (EVP, CFO)	17 Feb 2026	Sale	84,654	~$242.7–243.0	~$21.7m	Not verified on EDGAR (reported by Investing.com)

The August–September 2026 rows were checked against Form 4 XML filings on SEC EDGAR, and none has the 10b5-1 box ticked.

10. Risks and Challenges

Talc litigation (Legal): The $5.5bn ovarian proposal depends on at least 95% participation. J&J carries no third-party product-liability insurance and uses a captive insurer. Individual verdicts are still being handed down.
Loss of exclusivity (Competitive): Stelara is losing sales to biosimilars. Darzalex, about 15% of FY2025 sales, has US patents expiring in 2029, and J&J pays Genmab royalties on it.
US drug pricing (Regulatory): Medicare negotiated prices apply to Xarelto, Stelara and Imbruvica from 2026, with Erleada from 2028. There are also Part D redesign costs, 340B exposure and the most-favoured-nation pricing agreement.
Orthopaedics separation (Execution): The spin-off or sale of DePuy Synthes may slip, cost more than planned ($377m pre-tax already in H1 2026) or deliver fewer benefits than expected.
Tariffs and geopolitics (Macro): Trade measures and US–China tensions are risks, and about 43% of sales are outside the US, which brings currency exposure.
Manufacturing and supply (Operational): J&J runs 63 plants, and complex cell therapies such as CARVYKTI need specialised capacity. Disruption would constrain sales.
Pipeline setbacks (R&D): Not every programme succeeds. A partnered Phase 2 depression drug (with Contineum) missed its goal on 14 Sep 2026.

11. Recent Developments

25 Sep 2026 — TREMFYA and CARVYKTI data. TREMFYA met its primary endpoint in axial psoriatic arthritis. CARVYKTI data showed 50% of early-line patients in treatment-free remission at five years.
21 Sep 2026 — CAPLYTA bipolar mania Phase 3 positive. The study met its primary endpoint, supporting a further indication.
14 Sep 2026 — RYBREVANT survival data; partnered depression miss. At WCLC, RYBREVANT plus chemotherapy showed the longest reported median overall survival in EGFR exon 20 lung cancer. On the same day, Contineum's depression drug developed with J&J missed its Phase 2 goal.
11 Sep 2026 — DePuy Synthes sale talks reported. Bloomberg reported that Apollo is in talks to buy the orthopaedics business for close to $20bn. No agreement had been announced by 28 Sep 2026, and a spin-off remains possible.
24 Aug 2026 — IMAAVY approved for wAIHA. The FDA approved nipocalimab as the first treatment for warm autoimmune hemolytic anemia. The same day, a Louisiana jury returned a $10m talc mesothelioma verdict.
04 Aug 2026 — Innovative Medicine leadership change. Jennifer Taubert is to retire, with Tom Cavanaugh taking over from September.
29 Jul 2026 — Firefly Bio acquisition closed. The $1bn cash deal adds a degrader-antibody conjugate oncology platform.
27 Jul 2026 — $5.5bn ovarian talc resolution proposed. The proposal covers about 76,000 claims and needs at least 95% participation. No more than $3bn is payable in 2027.
22 Jul 2026 — OTTAVA authorised. The FDA granted De Novo authorisation for the OTTAVA robotic surgical system in upper-abdominal general surgery.
15 Jul 2026 — Q2 2026 results and guidance raised. Sales were $25,310m (+6.6%), GAAP EPS $2.27 and adjusted EPS $2.90. The 2026 guidance midpoints moved to $101.1bn sales and $11.68 adjusted EPS.

12. Key Dates Coming Up

13 Oct 2026 — Q3 2026 results, with the conference call at 8:30am ET.
08 Dec 2026 — Enterprise Business Review investor event, per the Q1 2026 release.
TBC — Next quarterly dividend declaration. The last was $1.34 per share, paid 08 Sep 2026.
Expected 2027 — First payment under the proposed ovarian talc resolution (no more than $3bn), if the participation threshold is met.
Expected mid-2027 — Target timing for separating the Orthopaedics business (DePuy Synthes), per CFO comments in July 2026.

Macro events are on the ChartsView Economic Calendar, and you can discuss J&J on the ChartsView Forum.

Last Updated: 25 September 2026

AstraZeneca goes into the final quarter of 2026 with a different US listing and a franchise mix in transition. Since 2 February 2026 its ordinary shares have traded directly on the New York Stock Exchange, replacing the Nasdaq American Depositary Shares. Its oncology business now brings in close to half of Total Revenue, and its largest single medicine, Farxiga, faces US generic competition that began in the second quarter. Management reconfirmed full-year guidance on 27 July 2026 and says the ambition of $80bn of revenue by 2030 is on track. Since then the late-stage pipeline has had approvals and failures in quick succession, and the Chief Executive has bought £7.26m of shares in the open market. This report sets out what the company's own results announcements, Form 20-F and regulatory news filings show. Every valuation input is shown as a calculation.

1. Company Snapshot

Field	Value
Company	AstraZeneca PLC, headquartered in Cambridge, United Kingdom
Ticker / exchange	AZN on the New York Stock Exchange (ordinary shares, trading since 2 February 2026), the London Stock Exchange and Nasdaq Stockholm. The Nasdaq ADS listing ended on 30 January 2026 and the ADR facility is closed
CEO / Leadership	Pascal Soriot (Executive Director and Chief Executive Officer); Dr Aradhana Sarin (Chief Financial Officer); Michel Demaré (Chair)
Employees	Approximately 96,100 in 2025, up from 94,300 in 2024 (Annual Report 2025)
Revenue (FY2025)	Total Revenue $58,739m, up 8.6% year on year (+8% at constant exchange rates)
Net income (FY2025)	Profit after tax $10,233m; reported diluted EPS $6.54; Core EPS $9.16
Revenue (trailing twelve months to 30 June 2026)	$61,366m
Market cap	~$255.2bn (1,550.9m shares at the $164.56 NYSE close of 24 September 2026)
Dividend	$3.20 per share declared for FY2025; the Board intends $3.30 for FY2026. The first interim dividend of $1.06 was paid on 8 September 2026
Most recent reported period	H1 and Q2 2026, reported 27 July 2026. Q3 2026 results are due on 30 October 2026

Live price action for AZN and the rest of the pharmaceutical sector can be followed on the ChartsView Live Charts page.

2. Bull Case and Bear Case

Bull Case

Oncology scale is still compounding: Oncology Total Revenue reached $25,619m in FY2025, 43.6% of the group, and rose to 46% of revenue in H1 2026. Imfinzi grew 29% to $6,063m and Enhertu 40% to $2,775m in FY2025.
Delivery against guidance: H1 2026 Total Revenue was $30,672m, up 9% (6% at constant exchange rates), and Core EPS was $5.21, up 12%. On 27 July 2026 management reconfirmed guidance for FY2026: Total Revenue up by a mid-to-high single-digit percentage and Core EPS up by a low double-digit percentage. It also described the $80bn 2030 revenue ambition as on track.
A productive regulatory year: 2026 has brought US approvals for Baxfendy (baxdrostat) in hypertension on 18 May, Datroway in first-line triple-negative breast cancer on 26 May and Etcamah (camizestrant) on 4 September. Tozorakimab was positive across three Phase III COPD trials. Management points to more than twenty high-value readouts over the next eighteen months.
Insiders are buying with their own money: Pascal Soriot bought 60,000 shares at £121.02 on 14 September 2026, about £7.26m, and the Chair bought 2,500 shares on the same day. These were open-market purchases, not share-plan vestings.
Positioned for US policy: AstraZeneca has committed $50bn to US manufacturing and R&D by 2030, including a $4.5bn Virginia plant. Its October 2025 pricing agreement with the US government carries a three-year tariff exemption. The direct NYSE listing lets US funds hold the ordinary shares.

Bear Case

The largest product is going generic: Farxiga was the single biggest medicine at $8,405m in FY2025. US generics launched in Q2 2026, and together with Chinese volume-based procurement they pushed Farxiga revenue down 6% in H1 2026.
Late-stage setbacks are accumulating: Wainua's CARDIO-TTRansform trial failed on 9 July 2026. eVOLVE-Lung02 for volrustomig was discontinued on 17 August. On 14 September SERENA-4 missed its progression-free survival endpoint in first-line breast cancer, which narrows camizestrant's commercial scope.
Debt is rising with deal spending: net debt rose from $23,374m at 31 December 2025 to $26,912m at 30 June 2026. Purchases of intangible assets, mostly licensing upfronts, were $3,333m in H1 2026 alone. The company priced a $2bn bond in February and a €2.55bn bond in August.
US pricing reform is now a margin line: the H1 2026 announcement names implementation of the US government pricing agreement as a gross-margin headwind. Farxiga was selected for Medicare negotiation under the Inflation Reduction Act, and the company lost its legal challenge to that selection.
China is both growth and legal exposure: China was 11% of FY2025 revenue at $6,654m. In February 2026 the Chinese unit and former China head Leon Wang were indicted, and dapagliflozin faces 33 patent invalidation challenges there.

3. Business Segments

AstraZeneca reports one operating segment, the discovery, development and commercialisation of medicines, but discloses Total Revenue by therapy area. The FY2025 split is below and adds to the reported total of $58,739m. By region, the United States was $25,450m (43%), Europe $12,739m (22%), Emerging Markets $15,303m (26%, of which China $6,654m) and Established Rest of World $5,247m (9%).

Segment / therapy area	% of revenue	What it is
Oncology	43.6% ($25,619m)	Tagrisso ($7,254m), Imfinzi ($6,063m), Calquence ($3,518m), Lynparza ($3,279m), Enhertu ($2,775m, alliance with Daiichi Sankyo) and Datroway
Cardiovascular, Renal and Metabolism (CVRM)	21.9% ($12,861m)	Farxiga ($8,405m), Crestor ($1,218m) and the new hypertension medicine Baxfendy (baxdrostat)
Rare Disease	15.5% ($9,126m)	Complement-inhibitor and enzyme-replacement medicines: Ultomiris ($4,718m), Soliris ($1,837m) and Strensiq ($1,678m)
Respiratory and Immunology (R&I)	15.1% ($8,866m)	Symbicort ($2,885m), Fasenra ($1,981m), Breztri ($1,199m) and Tezspire ($1,131m)
Vaccines and Immune Therapies (V&I)	2.2% ($1,268m)	Vaccines and antibodies against respiratory infections; reported as Infectious Disease from 2026 ($312m in H1 2026)
Other medicines	1.7% ($999m)	Older primary-care and legacy brands, plus collaboration and other revenue not attributed to a therapy area

4. Business Model and Moat

How it makes money. AstraZeneca discovers or licenses molecules and takes them through clinical trials. It then sells the approved medicines to hospitals, pharmacies, insurers and state health systems worldwide. Almost all revenue is Product Sales. The rest is Alliance and Collaboration Revenue, mainly its share of Enhertu and Datroway profits with Daiichi Sankyo. Pricing is set by negotiation with payers, so the economics depend on patent life, clinical differentiation and each country's reimbursement rules.

Where the durable advantage sits. The advantage lies in how broad and how long-dated the patent-protected portfolio is. The company has a leading position in EGFR-mutated lung cancer through Tagrisso and in front-line CLL through Calquence. Its antibody-drug conjugate franchise with Daiichi Sankyo is expanding into earlier lines of breast and lung cancer. The Rare Disease unit adds complement-inhibitor medicines such as Ultomiris, which sell at high prices to small patient populations. FY2025 Core operating profit of $18,478m on $58,739m of revenue funds a large R&D budget, and the global commercial footprint turns approvals into sales quickly.

Where the model is fragile. Every medicine eventually loses exclusivity, and Farxiga shows how fast that happens. Growth depends on replacing revenue with new launches that must succeed in Phase III. Pricing is increasingly set by governments: US Medicare negotiation and the 2025 pricing agreement, and Chinese volume-based procurement. The company also funds much of its pipeline by buying licences, which adds debt and intangible assets to the balance sheet before any revenue arrives.

5. Financial Health

All figures are in US dollars and come from AstraZeneca's full-year results announcements and Form 20-F, cross-checked against the company's SEC XBRL filings. Fiscal years end on 31 December. AstraZeneca reports under IFRS; "GAAP EPS" below is reported diluted EPS, and "Adjusted EPS" is the company's Core EPS.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	37,417	+40.6%	$0.08	$5.29	$2.87	$28,134m
FY2022	44,351	+18.5%	$2.11	$6.66	$2.90	$22,965m
FY2023	45,811	+3.3%	$3.81	$7.26	$2.90	$22,365m
FY2024	54,073	+18.0%	$4.50	$8.21	$3.10	$26,506m
FY2025	58,739	+8.6%	$6.54	$9.16	$3.20	$24,715m

† Long-term debt is non-current interest-bearing loans and borrowings at year end, per the balance sheet and the SEC XBRL LongtermBorrowings tag, excluding lease liabilities. Current interest-bearing borrowings were a further $3,104m at 31 December 2025. FY2021 revenue growth is against FY2020 Total Revenue of $26,617m; the FY2021 reported EPS of $0.08 was depressed by acquisition-related charges in that year. ‡ Core EPS is AstraZeneca's own adjusted measure. It excludes amortisation and impairment of intangibles, restructuring and certain legal and fair-value items.

Cash generation and balance sheet: FY2025 net cash from operating activities was $14,575m against purchases of property, plant and equipment of $2,810m and purchases of intangible assets of $3,095m. Depreciation, amortisation and impairment was $5,733m and reported operating profit $13,743m. In H1 2026 operating cash flow was $6,224m, PP&E purchases $1,310m and intangible purchases $3,333m, including the roughly $1.1bn CSPC obesity upfront. At 30 June 2026 cash and cash equivalents were $4,893m and other current investments $75m. Interest-bearing borrowings were $29,491m, made up of $5,808m current and $23,683m non-current, plus $2,748m of leases, leaving net debt of $26,912m.

Quarter / Half	Revenue ($m)	Adjusted EPS	GAAP EPS
Q2 2026	15,384	$2.63	$1.61
Q1 2026	15,288	$2.58	$1.99
Q4 2025	15,503	$2.12	$1.50
Q3 2025	15,191	$2.38	$1.64
Q2 2025	14,457	$2.17	$1.58
Q1 2025	13,588	$2.49	$1.88
FY2025 total	58,739	$9.16	$6.60

Quarterly reported EPS is basic EPS as presented in the quarterly results announcements, so the FY2025 total of $6.60 is basic; the diluted figure in the annual table is $6.54. H1 2026 totals: Total Revenue $30,672m, Core EPS $5.21, reported EPS $3.60 (diluted $3.58).

Q2 2026 Total Revenue of $15,384m was 6.4% above Q2 2025. The Q2 Core EPS of $2.63 compares with $2.17 a year earlier. The lower reported EPS reflects amortisation and higher intangible charges linked to the licensing deals of the first half.

6. Valuation Metrics

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

Metric	Value
Market cap	~$255.2bn (1,550.9m ordinary shares at the $164.56 NYSE close of 24 September 2026)
Trailing P/E (GAAP)	~24.6x (price $164.56 / trailing twelve-month reported diluted EPS $6.68 = FY2025 $6.54 − H1 2025 $3.44 + H1 2026 $3.58). On trailing Core EPS of $9.71 (Q3 2025 to Q2 2026) the multiple is ~16.9x
P/E (forward)	~16x (price $164.56 / ~$10.1 to $10.4 implied FY2026 Core EPS, which is FY2025 Core EPS of $9.16 grown at the low-double-digit percentage guided on 27 July 2026 at constant exchange rates). This is a company-guidance calculation, not a consensus estimate
P/S (TTM)	~4.2x (market cap $255.2bn / trailing Total Revenue $61.37bn)
Enterprise value	~$279.7bn (market cap $255.2bn + interest-bearing borrowings $29.5bn − cash and current investments $5.0bn, per the 30 June 2026 balance sheet). Including $2.7bn of lease liabilities would give ~$282.4bn
EV/EBITDA (TTM)	~13.8x (EV $279.7bn / EBITDA $20.33bn; EBITDA = trailing reported operating profit $13.97bn + depreciation, amortisation and impairment $6.36bn, on the wider cash-flow-statement basis that includes impairment)
P/FCF	~23.9x (market cap $255.2bn / free cash flow $10.67bn; FCF = trailing operating cash flow $13.70bn − PP&E purchases $3.03bn). If trailing intangible purchases of $4.62bn, mostly licensing upfronts, are also deducted, FCF is $6.04bn and the multiple is ~42x
Dividend yield	~1.9% on the $3.20 FY2025 dividend; ~2.0% on the intended $3.30 for FY2026
52-week high	$212.71 (February 2026, NYSE)
52-week low	$145.80 (September 2025). US prices before 2 February 2026 are former ADS prices restated to one ordinary share, since two ADSs equalled one share
Short interest (% of float)	0.13% of float, being 2,087,754 shares short at the 15 September 2026 settlement date (2,895,178 shares at 31 August 2026)
Days to cover	~0.7 days at the 15 September 2026 settlement date

The gap between reported and Core earnings is the most important thing in this table. Amortisation and impairment of acquired intangibles puts about $3 per share between the two EPS lines. Which figure a reader relies on largely decides whether the shares look like a high-teens or a mid-twenties multiple.

7. What Are They Building

Cardiovascular and metabolic. Baxfendy (baxdrostat), the first aldosterone synthase inhibitor for hypertension, was approved in the US on 18 May 2026. The oral PCSK9 inhibitor laroprovstat (AZD0780) is in the Phase III AZURE programme, while Merck's oral PCSK9 competitor was approved in July 2026. In obesity, the oral GLP-1 elecoglipron produced 10.5% weight loss at 26 weeks and 11.8% at 36 weeks in the Phase IIb VISTA study presented at ADA in June 2026. A once-monthly injectable portfolio licensed from CSPC in January 2026 cost $1.2bn upfront, with up to $3.5bn in milestones.

Oncology. Datroway gained US approval in first-line triple-negative breast cancer on 26 May 2026 and EU approval on 31 July. The AVANZAR first-line lung readout is due in the second half of 2026. Etcamah (camizestrant) received EU approval on 23 July and US accelerated approval on 4 September for ESR1-mutated breast cancer. The negative SERENA-4 result on 14 September limits it to that biomarker-selected setting for now. DESTINY-Lung04 extended Enhertu's benefit into first-line HER2-mutant lung cancer. Eight-year ADAURA data showed 79% of Tagrisso patients alive against 64% on placebo. Cell therapy is being built through AbelZeta's C-CAR031 GPC3 CAR-T, and the Dizal licence for Zegfrovy completed on 1 September 2026.

Respiratory and immunology. Tozorakimab, an anti-IL-33 antibody, was positive in the OBERON, TITANIA and PROSPERO COPD trials, with full data presented at ERS on 8 September 2026. It is under FDA priority review. Tezspire met its primary endpoints in the CROSSING trial on 27 August 2026, and Trixeo was approved in the EU for asthma on 23 September 2026.

Manufacturing and footprint. AstraZeneca plans to invest $50bn in US manufacturing and R&D by 2030, including a $4.5bn plant in Virginia, and expects the US to be about half of its targeted $80bn of 2030 revenue. It has also announced $15bn of investment in China through 2030. FY2026 capital expenditure is guided up by about one third.

8. Competitive Landscape

Market capitalisations were re-checked live on 24 September 2026. The revenue figures come from each company's own FY2025 results announcement.

Peer	Market cap (September 2026)	Key 2025 metric
Eli Lilly (LLY)	~$1,053bn	FY2025 revenue $65.2bn, up 45%, driven by its incretin obesity and diabetes franchise
AbbVie (ABBV)	~$468bn	FY2025 net revenue $61.16bn
Merck & Co (MRK)	~$365bn	FY2025 worldwide sales $65.0bn
Roche (RHHBY)	~$349bn	FY2025 group sales CHF 61.5bn across pharmaceuticals and diagnostics
Novartis (NVS)	~$273bn	FY2025 net sales $54.53bn with a 40% core operating margin
Pfizer (PFE)	~$162bn	FY2025 revenue $62.6bn

AstraZeneca's FY2025 Total Revenue of $58.7bn puts it in the same size band as AbbVie, Merck, Pfizer and Novartis. Its market value is the sixth largest in the group, below Roche and above Novartis. Lilly's incretin franchise has taken it into a valuation class of its own, and this is where AstraZeneca's obesity programme will be measured.

9. Insider Activity

AstraZeneca is a UK-incorporated company, so director dealings are disclosed as PDMR notifications on the London Stock Exchange rather than on SEC Form 4. Chief Executive Pascal Soriot and Chair Michel Demaré made the only discretionary open-market purchases of 2026 on 14 September 2026. The other entries are share-plan grants and vestings, which carry no signal about sentiment. Daily "Transaction in own shares" buyback notices are excluded.

Name	Date	Type	Shares	Price	Value	Plan Type
Pascal Soriot (CEO)	14 Sep 2026	Open-market purchase	60,000	—	—	Discretionary
Michel Demaré (Chair)	14 Sep 2026	Open-market purchase	2,500	—	—	Discretionary
Aradhana Sarin (CFO)	14 Sep 2026	Dividend-equivalent shares	73	Nil cost	n/a	Share plan
Aradhana Sarin (CFO)	17 Aug 2026	Vesting of 2021 award (net)	11,133	—	—	Performance Share Plan
Pascal Soriot (CEO)	14 May 2026	Vesting of 2021 award at 88% (net)	18,359	—	—	Performance Share Plan
Pascal Soriot (CEO)	04 Mar 2026	Award grant	103,581	—	—	Deferred Bonus Plan (13,970) and Performance Share Plan (89,611)
Aradhana Sarin (CFO)	04 Mar 2026	Award grant	42,393	—	—	Deferred Bonus Plan (5,258) and Performance Share Plan (37,135)

After the purchase, Soriot's disclosed direct holding was 941,175 shares.

10. Key Risks

US pricing policy: the October 2025 agreement with the US government is already a named gross-margin headwind in H1 2026. Farxiga is subject to Medicare price negotiation under the Inflation Reduction Act, and in December 2025 the company sued over Calquence's classification as a qualifying single-source drug. The US is 43% of revenue, and the company is targeting about half of 2030 revenue there.
Loss of exclusivity: Farxiga, the largest medicine at $8,405m in FY2025, lost US exclusivity in Q2 2026 and is exposed to Chinese volume-based procurement. Growth depends on newer medicines outgrowing these declines every year.
Pipeline execution: three late-stage programmes, Wainua in ATTR cardiomyopathy, volrustomig in lung cancer and camizestrant in first-line use, missed or were stopped between July and September 2026. The $80bn 2030 ambition assumes a high success rate across more than twenty readouts over the next eighteen months.
China legal and commercial exposure: the Chinese subsidiary and former China president Leon Wang were indicted in February 2026 on illegal-trade and personal-data charges. The company has also committed $15bn of new investment in China, where 11% of revenue is generated.
Balance-sheet load from business development: net debt rose $3.5bn in six months to $26,912m at 30 June 2026. Licensing upfronts of up to $1.2bn per deal, and milestone commitments running into billions, are added to a capital expenditure budget guided up by about one third for 2026.
340B and US litigation: AstraZeneca is litigating 340B drug-discount contract-pharmacy laws in about 21 US states with mixed results. It has adverse rulings under appeal in Arkansas and Colorado and a preliminary injunction in its favour in Oklahoma.

11. Recent Developments

23 Sep 2026 — Trixeo approved in the EU for asthma. The triple-combination inhaler, previously approved for COPD, gained an asthma indication. This extends the Breztri and Trixeo franchise, which recorded $1,199m of FY2025 revenue.
21 Sep 2026 — CHMP positive opinions for Klygefa and Enhertu. The EU committee recommended gefurulimab (Klygefa) in generalised myasthenia gravis and Enhertu in post-neoadjuvant early breast cancer, moving Enhertu into the curative-intent setting.
14 Sep 2026 — SERENA-4 missed its primary endpoint. Camizestrant plus a CDK4/6 inhibitor did not significantly improve progression-free survival in first-line HR-positive breast cancer. The same day, eight-year ADAURA data showed 79% overall survival with adjuvant Tagrisso against 64% on placebo.
14 Sep 2026 — CEO and Chair bought shares. Pascal Soriot bought 60,000 shares at £121.02, about £7.26m, and Michel Demaré bought 2,500 shares at £121.21.
08 Sep 2026 — Tozorakimab data at ERS and Imfinzi survival result. Full Phase III COPD data for tozorakimab were presented. Separately, Imfinzi combined with Imdelltra improved overall survival in small cell lung cancer.
07 Sep 2026 — Etcamah granted US accelerated approval. The FDA action on 4 September covers camizestrant with a CDK4/6 inhibitor for ESR1-mutated HR-positive, HER2-negative advanced breast cancer, based on SERENA-6.
01 Sep 2026 — Zegfrovy licence completed and Enhertu approved in the EU. The Dizal agreement ($600m upfront, up to $900m further) closed; Enhertu won EU approval in first-line HER2-positive metastatic breast cancer; and Wan Ling Martello joined the Board.
27 Aug 2026 — Tezspire CROSSING trial met its primary endpoints. The result adds to the evidence base for the anti-TSLP antibody, which recorded $1,131m of FY2025 revenue.
17 Aug 2026 — Mixed Phase III news in lung cancer. DESTINY-Lung04 showed improved progression-free survival for Enhertu in first-line HER2-mutant lung cancer, and Tagrisso plus Orpathys improved survival. However, the eVOLVE-Lung02 trial of volrustomig was discontinued.
02 Aug 2026 — Merger report hit the shares. The Financial Times reported talks between AstraZeneca and Bristol Myers Squibb on a combination valued at about $400bn, and the shares fell sharply in London. A Reuters source subsequently said no discussions were under way.
27 Jul 2026 — H1 2026 results and guidance reconfirmed. Total Revenue was $30,672m, up 9%, and Core EPS was $5.21, up 12%. FY2026 guidance and the $3.30 dividend intention were reaffirmed, and the first interim dividend was declared at $1.06.

12. Key Dates to Watch

26 Oct 2026 — AstraZeneca "Meet the Management" investor event at the ESMO 2026 congress.
30 Oct 2026 — 9M and Q3 2026 results announcement.
Expected Feb 2027 — FY2026 results and declaration of the second interim dividend. The Board intends a total of $3.30 for FY2026, of which $1.06 has been paid. The exact date has not yet been announced.
Expected Mar 2027 — payment of the second interim FY2026 dividend, in line with the company's usual March payment cycle.
TBC — US FDA decision on tozorakimab in COPD, under priority review; press reports point to the first quarter of 2027.
TBC — AVANZAR Phase III readout for Datroway in first-line non-small cell lung cancer, guided to the second half of 2026.
TBD — 2027 Annual General Meeting. The 2026 AGM was held on 9 April 2026.

Macro releases that move defensive healthcare stocks and sterling are listed on the ChartsView Economic Calendar. Reader discussion of these dates continues in the Forum.

Last Updated: 19 August 2026

Biogen is a company in the middle of a controlled handover. Its legacy multiple sclerosis franchise — TECFIDERA, TYSABRI, AVONEX, PLEGRIDY and VUMERITY — still supplied 40.8 per cent of FY2025 revenue but is shrinking at a double-digit rate, and generic and biosimilar entrants have now reached even TYSABRI. Against that, management has been buying and building a replacement: the $5.6bn Apellis acquisition closed on 14 May 2026 and added SYFOVRE and EMPAVELI; the FDA approved a subcutaneous at-home LEQEMBI autoinjector on 13 July 2026; and a high-dose SPINRAZA regimen was cleared on 30 March 2026. Whether the new portfolio outruns the old decline is the whole question. This report sets out what the filings say, with every figure traced to a company release, a 10-K, a 10-Q or a regulator, and no analyst ratings or price targets anywhere in it.

1. Company Snapshot

Field	Value
Company	Biogen Inc.
Ticker / Exchange	BIIB / NASDAQ
Headquarters	Cambridge, Massachusetts, United States
Founded	1978 (as Biogen N.V.)
Sector	Biotechnology and Pharmaceuticals
CEO / Leadership	Christopher A. Viehbacher, President and Chief Executive Officer (since November 2022). Robin Kramer, Executive Vice President and Chief Financial Officer (since March 2025). Dr Priya Singhal, Executive Vice President and Head of Development.
Employees	Approximately 7,500 as of 31 December 2025, down roughly 105 on the prior year, following net headcount reductions of about 1,400 under the Fit for Growth programme. Excludes staff added with Apellis and RayThera in 2026.
Revenue (FY2025)	$9,890.6m, up 2.2 per cent on FY2024 — the first annual increase since 2019
Net income (FY2025)	$1,292.9m, GAAP diluted EPS $8.79; non-GAAP diluted EPS $15.28
Market cap	Approximately $31.4bn (19 August 2026)
Share price	$212.55 (18 August 2026 close)
Reportable segments	One. Biogen manages the business as a single operating segment and discloses revenue by product category.
Dividend	None. Biogen has never paid a dividend on the common stock and did not initiate one in 2025 or the first half of 2026.

2. Bull and Bear Case

Bull Case

The growth portfolio has overtaken the legacy book: in Q2 2026 Biogen's stated growth portfolio — EMPAVELI, QALSODY, SKYCLARYS, SPINRAZA, SYFOVRE, VUMERITY, ZURZUVAE plus its 50 per cent LEQEMBI share — reached $1.06bn, up 24 per cent year on year, and is now larger than the legacy multiple sclerosis portfolio at $767m. FY2025 revenue rose for the first time since 2019.
At-home LEQEMBI dosing removes a real adoption barrier: the FDA approved LEQEMBI IQLIK as an initiation dose on 13 July 2026, following approval of the maintenance dose in August 2025. It is the first and only anti-amyloid therapy anywhere that permits at-home dosing across the entire treatment course, using two 250mg injections of about 15 seconds each. The US launch is set for late August 2026.
Apellis broadens the base into ophthalmology and nephrology: the acquisition closed on 14 May 2026 for roughly $5.6bn plus a contingent value right of up to $4 per share, adding SYFOVRE and EMPAVELI with $689m of combined 2025 net product revenue and a nephrology commercial platform. Management guides to at least $250m of run-rate synergies exiting 2027 and non-GAAP EPS accretion from 2027.
A dense catalyst calendar with five registrational readouts inside four quarters: both litifilimab Phase 3 studies in systemic lupus read out by the end of 2026, felzartamab Phase 3 in antibody-mediated rejection and litifilimab in cutaneous lupus in the first half of 2027, and zorevunersen in Dravet syndrome in Q3 2027. Salanersen received FDA Breakthrough Therapy Designation for spinal muscular atrophy on 4 June 2026.

Bear Case

Legacy erosion is severe and now reaching the last defended franchise: Q2 2026 multiple sclerosis product revenue of $963m fell 13 per cent year on year, with TECFIDERA down 53 per cent and PLEGRIDY down 20 per cent. Sandoz launched TYRUKO, the first US TYSABRI biosimilar, in November 2025 at roughly a 20 per cent discount, attacking a $1.67bn franchise that had been the stable part of the base.
LEQEMBI's commercial ramp is modest relative to the thesis: global in-market sales of $184m in Q2 2026 annualise to roughly $736m after three years on the US market, and Biogen books only its 50 per cent share — $63.7m in the quarter. Uptake remains gated by amyloid confirmation testing, MRI monitoring for amyloid-related imaging abnormalities, ApoE genotyping and the CMS coverage-with-evidence-development registry.
Earnings quality has deteriorated sharply: the Q2 2026 gap between GAAP diluted EPS of $0.66 and non-GAAP of $3.60 was $2.94 per share, comprising $200.6m of inventory step-up amortisation, $153.6m of intangible amortisation and $170.5m of restructuring. Reported FY2026 non-GAAP guidance was cut to $12.00 to $13.00 from $15.25 to $16.25, on roughly $3.00 of acquired in-process research charges and about $0.85 of Apellis financing dilution.
The balance sheet is materially more levered and more intangible-heavy: total debt rose from $6.3bn at 31 December 2025 to about $8.1bn at 30 June 2026 while cash fell from $3.0bn to $1.29bn and marketable securities went to zero. Intangible assets of $13.52bn plus goodwill of $6.99bn now stand at $20.5bn against $18.8bn of total equity, so a SYFOVRE or felzartamab disappointment becomes a write-down event as well as a revenue event.

3. Business Segments

Biogen manages and reports the business as a single operating segment, so the table below sets out the disclosed revenue categories for FY2025 rather than reportable segments. Percentages are of total revenue of $9,890.6m. A seventh category, specialised immunology, was added from Q2 2026 following the Apellis acquisition and contributed $127.8m in that quarter.

Segment / category	% of revenue	What it is
Multiple Sclerosis product revenue	40.8% ($4,038.9m)	TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. The historic core of the company, now in structural decline from generic and biosimilar entry.
Rare Disease	21.8% ($2,154.2m)	SPINRAZA for spinal muscular atrophy ($1,546.8m), SKYCLARYS for Friedreich's ataxia ($520.5m) and QALSODY for SOD1-ALS ($86.9m).
Anti-CD20 equity income and royalties	18.8% ($1,860.6m)	Royalties on Roche's OCREVUS ($1,414.9m) plus Biogen's share of US pre-tax profit on RITUXAN, GAZYVA and LUNSUMIO ($420.2m). High-margin income Biogen does not control commercially.
Contract manufacturing, royalty and other	7.4% ($732.9m)	Third-party manufacturing at Biogen's biologics facilities, plus miscellaneous royalty streams.
Biosimilars	7.4% ($729.1m)	BENEPALI, IMRALDI, FLIXABI, BYOOVIZ and TOFIDENCE, sourced through the Samsung Bioepis relationship. Being wound down — US and Canadian rights transferred as of 31 December 2025.
Other product revenue	2.0% ($197.2m)	Principally ZURZUVAE for postpartum depression ($195.1m), plus residual ADUHELM and FUMADERM.
Alzheimer's collaboration revenue	1.8% ($177.7m)	Biogen's 50 per cent share of LEQEMBI net revenue and cost of sales under the Eisai collaboration. Up 197 per cent on FY2024's $59.9m.

4. Business Model and Moat

How it makes money. Biogen sells specialty biologics and small molecules into neurology, rare disease and now ophthalmology and nephrology, largely through specialty pharmacy and hospital channels rather than retail. A meaningful slice of profit is not sold by Biogen at all: 18.8 per cent of FY2025 revenue came from royalties and profit shares on anti-CD20 antibodies commercialised by Roche and Genentech, and the LEQEMBI line is a 50 per cent share of a collaboration in which Eisai leads development, regulatory strategy and final decision-making. That structure is capital-light on the way up and gives Biogen very little control on the way down.

Where the moat comes from. The durable advantage is regulatory and clinical rather than commercial. SPINRAZA, QALSODY and salanersen all depend on antisense oligonucleotide chemistry and intrathecal delivery expertise that took two decades to build. Rare-disease indications carry orphan exclusivity, small and identifiable prescriber bases, and payer dynamics that reward first movers. In Alzheimer's, the diagnostic and monitoring infrastructure that slows LEQEMBI's launch — amyloid confirmation, MRI surveillance, genotyping — is also a barrier to anyone arriving later.

Where the model is exposed. Biogen's central problem is that its highest-margin revenue is either eroding or not under its control. The multiple sclerosis book is being competed away product by product; the anti-CD20 royalty stream belongs to Roche; LEQEMBI is Eisai's to steer; and the biosimilars economics sit with Samsung Bioepis. The replacement portfolio — SYFOVRE, EMPAVELI, felzartamab, litifilimab — has largely been bought rather than discovered, which is why goodwill and intangibles have grown to exceed total equity.

Cost discipline. The Fit for Growth programme targeted roughly $1.0bn of gross operating expense savings with about $300m reinvested, for net savings of around $700m, achieved through a net headcount reduction of approximately 1,400. It is visible in the numbers: FY2025 GAAP research and development spend fell 10 per cent to $1,778.6m. For live pricing and technical context on the shares, see the ChartsView Live Charts page.

5. Financial Health

All figures below are taken from Biogen's quarterly earnings releases and Forms 10-K and 10-Q, cross-checked against the company's XBRL filings with the SEC. Biogen's financial year ends on 31 December.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	10,981.7	-18.3%	$10.40	$19.22	$0.00	$6,274.0m
FY2022	10,173.4	-7.4%	$20.87	$17.67	$0.00	$6,281.0m
FY2023	9,835.6	-3.3%	$7.97	$14.72	$0.00	$6,788.2m
FY2024	9,675.9	-1.6%	$11.18	$16.47	$0.00	$4,547.2m
FY2025	9,890.6	+2.2%	$8.79	$15.28	$0.00	$6,286.8m

Adjusted EPS is Biogen's reported non-GAAP diluted earnings per share. Long-term debt is the non-current portion of notes payable at each year end, per the SEC XBRL tag LongTermDebt; a further $999.1m, $0m, $150.0m, $1,748.6m and $0m respectively sat in current liabilities at each of those dates. FY2022 GAAP EPS of $20.87 is flattered by a large one-off gain on the sale of Biogen's equity stake in the Samsung Bioepis joint venture.

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
Q2 2026 (to 30 Jun 2026)	$2,736.0m	$3.60	$0.66
Q1 2026 (to 31 Mar 2026)	$2,477.8m	$3.57	$2.15
Q4 2025 (to 31 Dec 2025)	$2,279.4m	$1.99	-$0.33
Q3 2025 (to 30 Sep 2025)	$2,534.7m	$4.81	$3.17
FY2025 total	$9,890.6m	$15.28	$8.79

Q2 2026 revenue includes SYFOVRE ($97.4m) and EMPAVELI ($30.4m) only from the 14 May 2026 Apellis completion date; on a full-quarter basis those products generated $162m and $46m respectively. Q4 2025 revenue is derived as FY2025 total less the three reported quarters and fell 7 per cent year on year.

Cash generation remains solid and is the counterweight to the earnings-quality complaints. Biogen produced operating cash flow of $2,204.6m in FY2025 against capital expenditure of only $153.8m, giving free cash flow of $2,050.8m — a 20.7 per cent free cash flow margin on revenue. Q2 2026 operating cash flow was $448.9m against $40.9m of capex. What has changed is the balance sheet: to fund Apellis, total debt rose to approximately $8.1bn at 30 June 2026 ($800m current plus $7,290m long-term), cash fell to $1,285.0m and marketable securities were run to zero, leaving net debt of roughly $6.8bn. First-half 2026 investing outflow was $4.05bn against a financing inflow of $1.25bn.

6. Valuation Metrics

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

Metric	Value
Market cap	Approximately $31.4bn (share price $212.55 × 147,753,998 shares outstanding). Weighted average diluted shares in Q2 2026 were 148.7m.
Trailing P/E (GAAP)	Approximately 37.8x on trailing-twelve-month GAAP diluted earnings per share of $5.63 (Q3 2025 $3.17 + Q4 2025 -$0.33 + Q1 2026 $2.15 + Q2 2026 $0.66). On Biogen's own non-GAAP measure the same four quarters total $13.97, putting the shares on roughly 15.2x adjusted earnings — a gap of well over 2x that reflects acquisition accounting, inventory step-up and restructuring rather than operating performance.
P/E (forward)	Approximately 17.0x on the midpoint of Biogen's own FY2026 reported non-GAAP guidance of $12.00 to $13.00 per share, issued 29 July 2026. On the company's "underlying" guidance of $15.85 to $16.85, which excludes acquired in-process research charges and Apellis financing dilution, the multiple is approximately 13.0x.
P/S (TTM)	Approximately 3.1x (market cap $31.4bn / trailing-twelve-month revenue $10,027.9m, being Q3 2025 $2,534.7m + Q4 2025 $2,279.4m + Q1 2026 $2,477.8m + Q2 2026 $2,736.0m).
EV/EBITDA (TTM)	Approximately 11.4x (enterprise value $38.2bn / trailing-twelve-month EBITDA of approximately $3,359m). Cross-checked on an FY2025 basis: operating income of $2,469.0m plus depreciation and amortisation of $779.9m gives EBITDA of $3,248.9m and a multiple of approximately 11.8x. The FY2025 D&A figure is the SEC tag DepreciationDepletionAndAmortization and ties exactly to depreciation of $272.8m plus intangible amortisation of $507.1m.
P/FCF	Approximately 15.3x on an FY2025 basis (market cap $31.4bn / free cash flow $2,050.8m; FCF = operating cash flow $2,204.6m less capital expenditure $153.8m per the FY2025 cash flow statement). Biogen's capital intensity is unusually low for a large biologics manufacturer, at about 1.6 per cent of revenue.
Enterprise value	Approximately $38.2bn (market cap $31.4bn + total debt $8,090m − cash and equivalents $1,285m; marketable securities were nil at 30 June 2026, having been liquidated to help fund the Apellis acquisition).
52-week high	$219.72
52-week low	$131.52
Short interest (% of float)	Approximately 3.9 to 4.1 per cent. MarketBeat reports 5,723,194 shares short at the 30 June 2026 settlement, or 3.89 per cent of float, up 10.3 per cent from the 15 June reading. Yahoo Finance shows 5,453,901 shares and 4.11 per cent. Short interest has risen roughly 50 per cent from its March 2026 trough of 3.83m shares.
Days to cover	Approximately 3.8 to 4.1 days, on average daily volume of roughly 1.27m to 1.42m shares.

7. What Are They Building

Biogen spent $1,778.6m on research and development in FY2025 on a GAAP basis, down 10 per cent, and $1,730.5m on a non-GAAP basis, down 7 per cent, with the reduction attributed primarily to Fit for Growth and to Royalty Pharma research funding. Separately, acquired in-process research and development, upfront and milestone expense was $471.8m in FY2025 against $61.5m in FY2024, and is guided at $290m to $320m in Q3 2026 alone. Management describes five registrational readouts arriving within four quarters and ten further potentially registrational studies over four years.

Lupus and immunology. Litifilimab is the nearest large catalyst, with both Phase 3 systemic lupus studies due to read out by the end of 2026 and the cutaneous lupus study in the first half of 2027; the FDA granted Breakthrough Therapy Designation in the cutaneous indication in February 2026. Felzartamab, acquired with HI-Bio, is in Phase 3 for antibody-mediated rejection in kidney transplant with a first-half 2027 readout, and a Phase 2 in Graves' disease is planned; Greater China rights were licensed to TJ Biopharma on 20 April 2026. Partner UCB published positive Phase 3 results for dapirolizumab pegol in systemic lupus in The Lancet on 1 June 2026.

Neuromuscular and rare disease. Salanersen received FDA Breakthrough Therapy Designation for spinal muscular atrophy on 4 June 2026, with Phase 1b data expected in Q3 2026, and additional data presented in March 2026 showed new motor milestones in children previously treated with gene therapy. Zorevunersen, partnered with Stoke Therapeutics, is in Phase 3 for Dravet syndrome with a Q3 2027 readout.

Alzheimer's. Diranersen, previously BIIB080, is a tau-targeting antisense oligonucleotide. Its Phase 2 CELIA study read out on 14 May 2026 and missed its primary endpoint of dose-response on change in CDR-SB, but the 60mg arm slowed decline by 0.54 points, or 26 per cent, on CDR-SB with supportive results on ADAS-Cog13, MMSE and modified iADRS and robust reductions in cerebrospinal fluid tau and tau-PET signal. Biogen is proceeding to Phase 3. On LEQEMBI itself, lecanemab is now approved in 53 countries, intravenous maintenance dosing is cleared in eight including the United States, China and the United Kingdom, and subcutaneous filings are pending in Japan and China.

Discontinued. BIIB122, the LRRK2 inhibitor partnered with Denali, failed its Phase 2b LUMA study in early-stage Parkinson's disease and development in idiopathic Parkinson's was discontinued in May 2026. Denali continues the Phase 2a BEACON study in carriers of a pathogenic LRRK2 variant independently. Biogen also added RayThera on 6 August 2026, a small-molecule immunology company whose lead asset entered Phase 1 in July 2026, for up to $1bn largely contingent on milestones.

8. Competitive Landscape

Biogen competes on two distinct fronts: against Eli Lilly in Alzheimer's, where Kisunla is the direct rival to LEQEMBI, and against a broad set of large-cap biopharma companies for the specialty and rare-disease franchises it is building. Eisai appears here as both partner and lead party on lecanemab. Market capitalisations below were retrieved live on 19 August 2026.

Peer	Market cap (August 2026)	Key 2025 metric
Eli Lilly and Company (LLY)	$1,093.0bn	FY2025 revenue of $65.18bn with net income of $20.64bn. Markets Kisunla (donanemab), the principal competitor to LEQEMBI in early symptomatic Alzheimer's disease.
Roche Holding AG (RHHBY)	$354.0bn	FY2025 group sales of CHF 63,356m. Controls OCREVUS, on which Biogen earned $1,414.9m of royalties in FY2025, and is developing trontinemab in Alzheimer's after discontinuing gantenerumab.
Novartis AG (NVS)	$293.8bn	FY2025 revenue of $56.67bn with net income of $13.98bn. Markets Zolgensma, a direct competitor to SPINRAZA in spinal muscular atrophy.
Amgen Inc. (AMGN)	$230.1bn	FY2025 revenue of $36.75bn with net income of $7.71bn. A direct competitor in biosimilars and large-molecule specialty medicine.
Vertex Pharmaceuticals Incorporated (VRTX)	$133.9bn	FY2025 revenue of $12.00bn with net income of $3.95bn. The clearest comparator for a rare-disease-led specialty model at scale.
Eisai Co., Ltd. (4523.T)	¥1,359.2bn	Revenue of ¥825.4bn for the year ended 31 March 2026. Lead partner on lecanemab with final decision-making authority, forecasting ¥143.5bn of LEQEMBI revenue for the year to March 2027, up 63 per cent.

9. Insider Activity

Christopher Viehbacher has been President and Chief Executive Officer since November 2022 and was quoted by name in the Q2 2026 results release on 29 July 2026. The pattern in Biogen's Form 4 filings over the past twelve months is a quiet one: there has been effectively no meaningful open-market insider buying, and the selling that has occurred is small in absolute terms, totalling under $1.3m across the transactions below. Routine tax-withholding and option-award rows, which dominate the filing history, are excluded. The Chief Executive's own 2026 activity — a 38,015-share option award on 13 February and an exercise of 24,461 shares on 6 February with 10,980 withheld for tax — is compensation rather than discretionary dealing.

Name	Date	Type	Shares	Price	Value	Plan Type
Lloyd Minor (Director)	04 Aug 2026	Sale	593	$200.96	$119,169	Rule 10b5-1 plan
Lloyd Minor (Director)	03 Aug 2026	Sale	593	$203.34	$120,581	Rule 10b5-1 plan
Nicole Murphy (Head of Pharmaceutical Operations and Technology)	12 Feb 2026	Purchase	3	$195.03	$585	Not stated, de minimis
Priya Singhal (Head of Development)	09 Feb 2026	Sale	2,660	$199.83	$531,548	Not stated
Priya Singhal (Head of Development)	02 Feb 2026	Sale	748	$179.30	$134,116	Not stated
Priya Singhal (Head of Development)	29 Aug 2025	Sale	517	$133.55	$69,045	Not stated
Rachid Izzar (Head of Global Product Strategy)	08 Jul 2025	Sale	2,223	$135.00	$300,105	Not stated

Biogen's share repurchase authorisation from October 2020 had approximately $2.1bn remaining at 31 December 2025, but treasury stock was unchanged at $2,977.1m at 31 December 2024, 31 December 2025 and 30 June 2026 — meaning effectively nothing was repurchased in 2025 or the first half of 2026. Capital went to acquisitions and debt service instead.

10. Key Risks

Legacy multiple sclerosis erosion: Q2 2026 MS product revenue of $963m fell 13 per cent year on year, and MS was still 40.8 per cent of FY2025 revenue. TECFIDERA has faced US generics since August 2020 and fell 53 per cent year on year in Q2 2026. Sandoz launched the first US TYSABRI biosimilar in November 2025 at roughly a 20 per cent discount, putting a $1.67bn franchise into the same trajectory.
SPINRAZA competition: FY2025 revenue of $1,546.8m was broadly flat to down and Q4 2025 fell 15 per cent year on year, against Roche's Evrysdi and Novartis's Zolgensma. The high-dose regimen approved on 30 March 2026 is the principal defence and is only two quarters into its conversion, so the durability of that fix is unproven.
LEQEMBI safety and label risk: lecanemab carries a boxed warning for amyloid-related imaging abnormalities, with symptomatic ARIA in 3 per cent of patients, serious ARIA in 0.7 per cent, and intracerebral haemorrhage greater than 1cm in 0.7 per cent against 0.1 per cent on placebo, including fatal cases. ApoE e4 homozygotes, roughly 15 per cent of Alzheimer's patients, show ARIA rates of about 45 per cent. Any post-marketing signal arising from unsupervised at-home subcutaneous dosing would be material given the IQLIK launch is imminent.
Intangible and goodwill impairment exposure: intangible assets of $13.52bn and goodwill of $6.99bn at 30 June 2026 total $20.5bn against total equity of $18.8bn. FY2025 already carried $11.4m of intangible impairment plus a $52.9m right-of-use asset impairment on the inherited Reata lease in Plano, Texas, and FY2024 carried $60.2m of acquired-intangible impairment. A clinical or commercial setback at SYFOVRE or felzartamab becomes a write-down as well as a revenue miss.
Leverage and financing cost: total debt roughly tripled relative to net cash position in six months, from $6.3bn of debt against $3.0bn of cash and $1.24bn of securities at 31 December 2025, to about $8.1bn of debt against $1.29bn of cash and nil securities at 30 June 2026. Q2 2026 non-GAAP other expense rose to $60m driven primarily by net interest, and Apellis financing accounts for roughly $0.85 of FY2026 EPS dilution. $800m of notes payable now sits in current liabilities.
Dependence on partners Biogen does not control: Eisai holds final decision-making authority over lecanemab; Roche and Genentech control OCREVUS, whose royalties were 14.3 per cent of FY2025 revenue and are the fastest-growing large line in the accounts; Samsung Bioepis controls the biosimilars economics, to which Biogen paid $219m of profit-sharing expense in FY2025; and Supernus co-commercialises ZURZUVAE.
Pipeline attrition: two of Biogen's three highest-profile 2026 readouts disappointed. The diranersen CELIA study missed its primary endpoint on 14 May 2026, and BIIB122 failed the Phase 2b LUMA study and was discontinued in idiopathic Parkinson's disease in May 2026. The litifilimab Phase 3 lupus readouts due by the end of 2026 are correspondingly higher stakes.
Litigation: on 30 September 2025 the US District Court for the Northern District of California ordered Biogen to pay Genentech $88,348,123 in unpaid Cabilly-patent royalties, with a further $35,903,701 of interest stipulated on 3 October 2025. This flowed through FY2025 as a $104.8m GAAP cost-of-sales charge plus $131.0m within GAAP other expense, roughly $236m in total.

11. Recent Developments

06 Feb 2026 — Q4 and full year 2025 results beat guidance but Q4 was weak. FY2025 revenue of $9,890.6m rose 2.2 per cent and non-GAAP EPS of $15.28 exceeded the $14.50 to $15.00 guidance range, but Q4 revenue fell 7 per cent and Q4 GAAP EPS was negative $0.33. Initial FY2026 guidance called for a mid-single-digit revenue decline.
30 Mar 2026 — FDA approves the high-dose SPINRAZA regimen. This followed an earlier FDA rejection and is the key defence of a $1.5bn franchise. Conversion has since been described by management as running ahead of company expectations in all launched geographies.
31 Mar 2026 — Biogen agrees to acquire Apellis Pharmaceuticals. $41 per share in cash, roughly $5.6bn, plus a contingent value right of up to $4 per share tied to SYFOVRE sales thresholds. Adds SYFOVRE in geographic atrophy and EMPAVELI in paroxysmal nocturnal haemoglobinuria and C3 glomerulopathy, with $689m of combined 2025 net product revenue.
14 May 2026 — Diranersen Phase 2 CELIA results miss the primary endpoint. The tau antisense oligonucleotide failed on dose-response in CDR-SB change from baseline, but the 60mg arm slowed decline by 26 per cent on CDR-SB with supportive secondary results and clear tau-pathology reduction. Biogen is advancing to Phase 3 regardless.
14 May 2026 — Apellis acquisition completes. 105,687,831 shares, or 82.4 per cent, were tendered; the merger closed under DGCL section 251(h) and Apellis was delisted from Nasdaq.
21 May 2026 — BIIB122 discontinued in idiopathic Parkinson's disease. The Phase 2b LUMA study of the LRRK2 inhibitor, partnered with Denali Therapeutics and enrolling 648 patients, missed both its primary and secondary endpoints and did not slow disease progression versus placebo. Denali continues the Phase 2a BEACON study in LRRK2 variant carriers independently.
04 Jun 2026 — Salanersen receives FDA Breakthrough Therapy Designation in spinal muscular atrophy, following March 2026 data showing new motor milestones in children previously treated with gene therapy.
17 Jun 2026 — Biogen agrees to acquire RayThera. Up to $1bn, predominantly contingent on clinical and regulatory milestones, adding multiple small-molecule immunology programmes. The transaction completed on 6 August 2026.
13 Jul 2026 — FDA approves LEQEMBI IQLIK as an initiation dose. The regimen is 500mg once weekly as two 250mg subcutaneous injections of roughly 15 seconds each, and patients may switch between intravenous and subcutaneous at any point. It is the first anti-amyloid therapy anywhere permitting at-home dosing across the entire treatment course. US launch is set for late August 2026.
14 Jul 2026 — Real-world LEADER study presented at AAIC. More than 75 per cent of early Alzheimer's patients remained stable and approximately 7 per cent improved over an average of 17 months of LEQEMBI treatment. Subcutaneous autoinjector data showed efficacy and safety similar to intravenous dosing.
29 Jul 2026 — Q2 2026 results raise revenue guidance but cut reported EPS guidance. Revenue of $2,736.0m rose 3 per cent and the growth portfolio reached $1.06bn, up 24 per cent and now larger than legacy MS. FY2026 revenue guidance moved from a mid-single-digit decline to a mid-single-digit increase and underlying EPS guidance rose $0.60 to $15.85 to $16.85, but reported guidance fell to $12.00 to $13.00 on roughly $3.00 of acquired in-process research charges and $0.85 of Apellis dilution. Biogen also announced Phase 2 proof of concept for BIIB091 in relapsing-remitting multiple sclerosis.
06 Aug 2026 — RayThera acquisition completes. The lead asset had entered Phase 1 in July 2026.

12. Key Dates and Catalysts

Expected August 2026 — US commercial launch of the LEQEMBI IQLIK initiation dose through specialty pharmacy, guided by the company to late August 2026.
Expected September 2026 — Phase 1b salanersen data in spinal muscular atrophy, guided to Q3 2026.
Expected September 2026 — the guided $290m to $320m of acquired in-process research and milestone expense, worth roughly $1.75 to $1.95 per share, lands in Q3 2026 reported earnings.
Expected October 2026 — Q3 2026 results. Biogen's investor relations events page listed no upcoming events as of 19 August 2026. Precedent: Q3 2025 was reported on 30 October 2025 and Q2 2026 on 29 July 2026. Track confirmed release dates on the ChartsView Economic Calendar.
Expected December 2026 — registrational Phase 3 readouts from both litifilimab studies in systemic lupus erythematosus. This is the single largest binary event on the four-quarter calendar.
Expected June 2027 — Phase 3 felzartamab readout in antibody-mediated rejection, and Phase 3 litifilimab readout in cutaneous lupus erythematosus, both guided to the first half of 2027.
Expected September 2027 — Phase 3 zorevunersen readout in Dravet syndrome, guided to Q3 2027.
Expected December 2027 — Apellis run-rate synergies of at least $250m to be achieved exiting 2027, with the acquisition guided to be accretive to non-GAAP earnings per share in that year.

No PDUFA dates are currently outstanding: the two 2026 action dates, on high-dose SPINRAZA and the LEQEMBI IQLIK initiation dose, resolved in approval on 30 March and 13 July 2026 respectively. Subcutaneous lecanemab filings are pending in Japan and China with no disclosed action dates. No investor day is scheduled. Readers comparing notes on biopharma names can do so in the ChartsView Forum.

Last Updated: 23 September 2026

OXB plc — legally still Oxford Biomedica plc — is a contract development and manufacturing organisation (CDMO) for cell and gene therapies. It makes the viral vectors, principally lentiviral and adeno-associated virus (AAV) vectors, that biotech and pharma clients use to deliver genetic material into patients' cells, and it earns fees for developing processes and manufacturing batches under contract. 2026 has been a year of sharp swings: the board rejected four take-private proposals from EQT in January and February, then on 7 August cut full-year revenue guidance to £180–200m from £220–240m. This report sets out the figures from the company's own results announcements, with no analyst opinions and no price targets.

1. Company Snapshot

Field	Value
Legal name	Oxford Biomedica plc, trading as OXB since September 2024
Exchange / ticker	London Stock Exchange Main Market, OXB (OXB.L)
Sector	Healthcare — cell and gene therapy CDMO (viral vector development and manufacturing)
Sites	Oxfordshire, UK; Lyon and Strasbourg, France; Bedford, Massachusetts and Durham, North Carolina, US
CEO / Leadership	Dr Frank Mathias, Chief Executive Officer. CFO Dr Lucinda Crabtree; Chair Dr Roch Doliveux; COO Eric Schmidhäuser (joined August 2026)
Employees	1,017 at 30 June 2026 (986 at 31 December 2025)
Revenue (FY2025)	£168.7m, up 31% reported
Net income (FY2025)	Loss after tax £30.6m; basic EPS (26.92)p
Shares in issue	121,049,785 at 31 August 2026, none in treasury
Client book	50 clients and 59 programmes as at September 2026, including 3 commercial agreements
Reporting currency / year end	Pounds sterling; 31 December. Half-yearly results with trading updates

OXB earns most of its revenue in US dollars from US clients but reports in sterling, so the constant-currency figures it quotes alongside reported numbers differ slightly. The company pays no dividend.

2. Bull Case and Bear Case

Bull Case

Revenue is growing again: revenue rose 31% to £168.7m in FY2025 and a further 9% to £79.8m in H1 2026. About £168m of the guided FY2026 revenue was covered by contracts as at September 2026.
A broadening client base: OXB added 17 new clients in H1 2026 and 4 more after the period end, taking the book to 50 clients and 59 programmes, up from 40 clients and 48 programmes in March 2026. Its non-risk-adjusted pipeline is about $713m, up roughly 30% year on year.
Multi-site, multi-vector capacity now in place: Durham's GMP facility is online with its first GMP run complete, the French AAV and lentiviral suites are GMP-qualified, and Oxfordshire's capacity expansion was completed in H1 2026. The company offers both lentiviral and AAV work on two continents.
Management's stated medium-term trajectory: revenue growth of 25–30% in both FY2027 and FY2028, at least double-digit EBITDA margin in FY2027, and an ambition of about £500m of revenue in 2030.
Strategic value was tested by a bidder: EQT made four take-private proposals in January and February 2026, all rejected by the board as undervaluing the company, before walking away on 25 February.

Bear Case

Guidance has already been cut once: on 7 August 2026 FY2026 revenue guidance fell from £220–240m to £180–200m, and the EBITDA margin target dropped from about 10% to mid-single digits excluding one-offs, citing client deferrals, staged ordering and a six-month delay at Durham.
Heavy client concentration: the two largest clients provided about 71% of H1 2026 revenue (£42.0m and £14.2m), up from about 62% in FY2025. A single client's procurement change was one of the reasons for the guidance cut.
Still loss-making and burning cash: the H1 2026 loss after tax was £37.0m and net cash used in operating activities was £17.4m. Cash fell from £96.9m at the year end to £66.8m at 31 August 2026.
Short sellers are building positions: the FCA aggregated net short position rose from 2.02% on 9 July to 7.67% on 21 September 2026.

3. Revenue Segments

OXB reports revenue by type of service. The FY2025 split is below; in H1 2026 manufacturing rose to 54% of revenue, development was 34%, procurement 10.6% and licences 1.5%.

Segment	% of revenue	What it is
Manufacturing — £81.1m	48.1%	GMP production of viral vector batches for clinical trials and commercial supply, including commercial lentiviral vector supply under a multi-year agreement with BMS signed in February 2026
Development — £60.1m	35.6%	Process and analytical development work that takes a client's vector from research towards a manufacturable, regulator-ready process
Procurement and storage — £22.3m	13.2%	Raw materials procured and recharged to clients, plus storage of client material
Licences, milestones and royalties — £5.2m	3.1%	Income from licensing OXB's vector technology and intellectual property to partners

By client location in FY2025, the US accounted for 83.9% of revenue (£141.6m), Europe 14.2%, the UK 1.8% and the rest of the world 0.1%.

4. Business Model & Moat

How it makes money. OXB is a service business. Clients pay for development work, for manufacturing runs, and for materials procured on their behalf. Revenue is recognised as work progresses, so it rises and falls with clients' clinical timetables. Early-stage programmes bring development fees; programmes that reach late-stage trials and commercial approval bring recurring manufacturing revenue. Of the 59 programmes in the book in September 2026, 50 were pre-clinical to early clinical, 6 late-stage clinical and 3 commercial.

What protects it. Viral vector manufacturing is technically demanding and heavily regulated. OXB's platforms include LentiVector and the TetraVecta fourth-generation lentiviral system, the inAAVate dual-plasmid AAV platform and stable producer cell lines, plus an FDA-approved commercial-scale site in Durham. Once a client has run a trial on vector from a particular process and site, switching manufacturer means re-validating, which creates stickiness for programmes that progress.

Operating leverage cuts both ways. The cost base — people, cleanrooms and leases — is largely fixed. Gross margin fell to 37% in H1 2026 from 43% a year earlier as new capacity in Durham and France carried costs ahead of revenue. Management targets an EBITDA margin approaching 30% by FY2030/31 if utilisation rises as planned.

Where the model is weakest. Revenue depends on a small number of large clients and on biotech funding conditions that determine whether clinical programmes proceed. The August 2026 guidance cut showed how quickly deferrals translate into lower revenue.

5. Financial Health

All figures below come from OXB's own preliminary and interim results announcements. Revenue is in pounds sterling; EPS in pence.

Fiscal Year	Revenue (£m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	142.8	+62.8%	22.77p	22.77p†	Nil	Nil
FY2022	140.0	-2.0%	(41.29)p	(41.29)p†	Nil	£39.8m
FY2023	89.5	-36.1%	(163.11)p	(163.11)p†	Nil	£38.5m
FY2024	128.8	+43.9%	(41.75)p	(41.75)p†	Nil	£39.8m
FY2025	168.7	+31.0%	(26.92)p	(26.92)p†	Nil	£41.5m

† OXB does not report adjusted EPS; the Adjusted EPS column repeats basic IFRS EPS. The FY2021 YoY figure is against FY2020 revenue of £87.7m; FY2021 revenue was lifted by manufacturing of the Oxford/AstraZeneca COVID-19 vaccine. Long-term debt is non-current loans (the Oaktree facility) and excludes lease liabilities, which were £100.6m non-current at 31 December 2025.

OXB reports half-yearly. The table below runs most recent period first, with the FY2025 total in bold.

Quarter / Half	Revenue	Adjusted EPS	GAAP EPS
H1 2026 (to 30 Jun 2026)	£79.8m	(30.39)p†	(30.39)p
H2 2025 (derived)‡	£95.5m	~(1.57)p†	~(1.57)p
H1 2025 (to 30 Jun 2025)	£73.2m	(25.35)p†	(25.35)p
H2 2024 (derived)‡	£78.0m	~(10.87)p†	~(10.87)p
FY2025 total	£168.7m	(26.92)p†	(26.92)p

† No adjusted EPS is reported; basic EPS is repeated. ‡ Second-half figures are derived by subtracting the reported first half from the full year. Derived EPS is approximate because the share count rose after the August 2025 placing.

Profitability. FY2025 operating EBITDA, on OXB's own definition, was £2.3m reported (£8.1m at constant currency), including a one-off £9.9m gain on the Durham acquisition; the operating loss was £22.5m. In H1 2026 operating EBITDA was a loss of £7.8m (adjusted £(2.5)m, excluding Durham pre-revenue and integration costs, Bedford redundancies and one-offs) and the operating loss widened to £29.1m, including a £7.6m impairment of French property, plant and equipment.

Cash flow, FY2025. Net cash generated from operating activities was £0.5m after a £5.1m R&D tax credit receipt. Purchases of property, plant and equipment were £4.8m, so free cash flow was about negative £4.3m. Depreciation was £17.6m and amortisation £2.3m, a combined £19.8m. Lease payments were a further £12.4m, and the August 2025 placing at 431p raised £58.1m net.

Cash flow, H1 2026. Net cash used in operating activities was £17.4m and capex £6.9m. OXB's own net cash outflow measure, which also includes interest and leases, was £34.3m.

Balance sheet. Cash was £96.9m at 31 December 2025, £75.3m at 30 June 2026 and £66.8m at 31 August 2026. Non-current loans under the Oaktree facility were £53.8m at 30 June 2026 ($75m drawn of a facility of up to $125m maturing August 2029), with no current borrowings. Lease liabilities totalled £104.8m. Net assets fell to £58.1m from £91.3m. The board states that the group would continue to comply with its Oaktree covenants beyond December 2027 even if all downside scenarios crystallised, and that if base-case cash flows do not materialise it will begin mitigating actions by the end of Q4 2026.

Guidance (reiterated 22 September 2026). FY2026 revenue £180–200m at constant currency; EBITDA margin mid-single-digit % excluding one-off costs and low-single-digit % reported; FY2027 and FY2028 revenue growth of 25–30%; FY2027 EBITDA margin at least double-digit; about £50m of capex across 2026–27, then £20–25m a year.

6. Valuation Metrics

Share prices, and figures worked out from them, are not shown for London-listed companies on ChartsView.

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

Metric	Value
Short interest (% of float)	7.67% of issued share capital, FCA aggregated net short position at 21 September 2026, up from 2.02% on 9 July 2026. The FCA reports against issued share capital, not free float

7. What Are They Building

A four-country manufacturing network. OXB has spent 2025–26 turning a UK lentiviral specialist into a multi-site, multi-vector CDMO. Durham, North Carolina — bought from a Resilience subsidiary for $4.5m in October 2025 — is an FDA-approved commercial-scale site; GMP is now online there and the first GMP run is complete, with commercial AAV manufacturing and fill-finish to follow, about six months later than originally planned. In France, AAV and 200-litre lentiviral suites are GMP-qualified, with the first full-scale GMP runs due in H2 2026. Oxfordshire completed a GMP capacity expansion in H1 2026. Bedford, Massachusetts has been refocused on process and analytical development only.

Platforms. The technology stack includes LentiVector and the TetraVecta fourth-generation lentiviral system, the inAAVate dual-plasmid AAV platform with a multi-serotype purification toolbox, AdenoVate, stable producer and packaging cell lines, and process work for in vivo CAR-T lentiviral vectors. A fast-track offering launched on 13 April 2026 promises AAV to GMP in as little as seven months and lentiviral vectors in as little as nine.

Commercial pipeline. OXB signed a multi-year commercial lentiviral supply agreement with BMS on 4 February 2026, a licensing and option agreement with VVMF in Australia on 18 March, and an AAV process development and GMP agreement with Plowshare Therapies on 16 July, to be run at Durham. The client book stood at 50 clients and 59 programmes in September 2026. The June 2026 Capital Markets Event set out an ambition of about £500m of revenue in 2030 and an EBITDA margin approaching 30% by FY2030/31, with capex of about £50m across 2026–27.

8. Peer Comparison

Peer	Key 2025 metric
OXB (OXB.L)	FY2025 revenue £168.7m, +31%; operating EBITDA £2.3m (company results, 26 Mar 2026)
Lonza (LONN.SW)	FY2025 sales CHF 6.5bn, +21.7% at constant exchange rates; CORE EBITDA margin 31.6% (company release, 28 Jan 2026)
Samsung Biologics (207940.KS)	FY2025 revenue KRW 4,557bn; operating profit KRW 2.07tn (company release)
Fujifilm Holdings (4901.T), parent of Fujifilm Diosynth	Group revenue ¥3,357.0bn for the year to March 2026; biologics CDMO revenue is not separately disclosed in the release reviewed
Charles River Laboratories (CRL)	FY2025 revenue $4.02bn, down 0.9% (company release)

OXB is a fraction of the size of the diversified CDMOs above, each of which spans far more modalities. Its direct viral-vector competitors are mostly private or divisions of larger groups: AGC Biologics is a subsidiary of AGC Inc and Genezen is privately held. That scarcity of listed pure-play vector manufacturers is one reason OXB attracted private-equity interest in early 2026.

9. Insider Activity

CEO Dr Frank Mathias and CFO Dr Lucinda Crabtree received long-term incentive and deferred bonus awards in April 2026; neither has made an open-market purchase or sale in 2026. The market sales below were by other senior managers (PDMRs) on exercising options and vested awards. Figures are from OXB's PDMR dealing RNS announcements; values are derived from shares multiplied by price.

Name	Date	Type	Shares	Plan Type
Lisa Doman (CPO)	22 May 2026	Exercise + sale	3,564	Deferred bonus plan
Natalie Walter (CLO)	22 May 2026	Exercise + sale	3,816	Deferred bonus plan
Kathleen Miller (Head of HR)	18 May 2026	Vest + sale	4,486 vested; 1,578 sold	Restricted stock units
Lisa Doman (CPO)	12 May 2026	Exercise + sale	13,300	Deferred bonus plan and ESOS options
Natalie Walter (CLO)	12 May 2026	Exercise + sale	3,057	SAYE options (exercise price 294.4p)
Dr Frank Mathias (CEO)	07 Apr 2026	Award	478,119 LTIP + 71,891 DBP	2026 LTIP and deferred bonus plan; 2024 and 2025 LTIP awards of 43,790 and 46,195 also reinstated
Dr Lucinda Crabtree (CFO)	07 Apr 2026	Award	156,884 LTIP + 47,179 DBP	2026 LTIP and deferred bonus plan

Substantial-holder movements have been more significant than director dealings. Vulpes Investment Management cut its holding to 5.78% from 6.56% (RNS 3 September 2026), and Irenic Capital Management disclosed a 5.41% interest on 17 September 2026, of which 5.35% is held through financial instruments rather than shares.

10. Key Risks

Client concentration (Commercial): the two largest clients provided about 71% of H1 2026 revenue. A change in procurement or approval pathway at one larger client contributed directly to the August 2026 guidance cut.
Programme deferrals and staged ordering (Commercial): clients deferring programmes or ordering work in smaller stages reduce near-term revenue visibility; OXB names failure to convert opportunities and rapid technological change among its principal risks.
Execution of the site network (Operational): Durham's GMP readiness slipped by six months and the French operation required a £7.6m impairment in H1 2026. Both the US and French cost centres missed budget.
Cash burn and covenant headroom (Financial): cash fell from £96.9m to £66.8m between December 2025 and August 2026. The board says covenants remain met in its downside case but has flagged possible investment cuts, site rationalisation and workforce reductions from the end of Q4 2026 if base-case cash flows do not materialise.
Quality and regulatory (Regulatory): as a GMP manufacturer of material for patients, OXB is exposed to batch failures, inspection findings and product-quality claims; outdated GMP documentation and quality records are listed among its risks.
Currency (Financial): about 84% of revenue comes from US clients and the Oaktree loan is dollar-denominated, while the company reports in sterling.

11. Recent Developments

22 Sep 2026 — H1 2026 interim results. Revenue £79.8m, up 9% (10% at constant currency). Operating EBITDA £(7.8)m; adjusted £(2.5)m. Loss after tax £37.0m, including a £7.6m impairment of French assets. Cash £75.3m at 30 June. FY2026 guidance of £180–200m revenue reiterated; 17 new clients in the half and 4 since.
21 Sep 2026 — Short position reaches 7.67%. The FCA's aggregated net short position for OXB rose to 7.67% at 21 September, from 3.71% on 7 August.
17 Sep 2026 — Irenic Capital discloses 5.41%. The interest is almost entirely held through financial instruments (5.35%), announced by RNS on 21 September.
03 Sep 2026 — Vulpes reduces stake. Vulpes Investment Management's holding fell to 5.78% from 6.56% in July.
07 Aug 2026 — Half-year trading update and guidance cut. FY2026 revenue guidance lowered to £180–200m from £220–240m and EBITDA margin guidance to mid-single digits excluding one-offs, citing client programme deferrals, staged ordering, a procurement change at a larger client and a six-month Durham delay.
16 Jul 2026 — Plowshare Therapies agreement. AAV process development and GMP manufacturing agreement, to be carried out at Durham.
02 Jun 2026 — Capital Markets Event. OXB set an ambition of about £500m of revenue in 2030 and an EBITDA margin approaching 30% by FY2030/31.
26 Mar 2026 — FY2025 results. Revenue £168.7m, up 31%; operating EBITDA £2.3m; loss after tax £30.6m; cash £96.9m at 31 December 2025.
25 Feb 2026 — EQT walks away. EQT confirmed it would not make an offer after the board rejected four take-private proposals as undervaluing OXB.

For the macro and rate backdrop that drives biotech funding, see the ChartsView Economic Calendar.

12. Key Dates to Watch

24 Sep 2026 — management presentation to retail investors on the Investor Meet Company platform, following the interim results
Expected Q4 2026 — business update per the company's investor calendar; also the point by which the board has said it would start mitigating actions if base-case cash flows do not materialise. No date published
Expected Feb 2027 — FY2026 trading update, the first read on whether revenue landed within the £180–200m guidance. No date published
Expected Mar 2027 — FY2026 preliminary results. FY2025 results were published on 26 March 2026; no FY2026 date has been announced
Expected May 2027 — Annual General Meeting; the 2026 AGM was held on 7 May 2026
Expected Aug 2029 — maturity of the Oaktree senior secured facility of up to $125m

Discuss this research with other investors in the ChartsView Forum.

Last Updated: 2 September 2026

Hims & Hers Health sells prescription and non-prescription treatment on a recurring subscription, across sexual health, hair loss, dermatology, mental health, hormone health, weight loss and, since 2025, at-home diagnostics. It has grown revenue from $271.9m in FY2021 to $2,347.6m in FY2025, and the trailing twelve months to 30 June 2026 reached $2,578.1m. It is also, in 2026, a company being sued by the Federal Trade Commission, investigated by the Securities and Exchange Commission's enforcement division, referred to the Department of Justice, placed under a Visa monitoring programme, and running GAAP losses for the first time in two years while integrating a $1.15bn acquisition. Both halves of that description are true simultaneously, and this report sets out what the filings say about each — without ratings or price targets.

1. Company Snapshot

Field	Value
Company	Hims & Hers Health, Inc.
Ticker / exchange	HIMS, New York Stock Exchange
Sector	Healthcare — consumer telehealth and direct-to-consumer pharmacy
Market cap	~$6.64bn at the close on 1 September 2026
Share price	$28.44 (close, 1 September 2026)
Revenue (FY2025)	$2,347.6m, up 59.0% year on year; trailing twelve months to 30 June 2026 $2,578.1m
Net income (FY2025)	$128.4m. The trailing twelve months to 30 June 2026 is a net loss of ~$142.0m.
GAAP diluted EPS (FY2025)	$0.51
Adjusted EBITDA (FY2025)	$318.0m; trailing twelve months $249.3m
Subscribers	2,891,000 at 30 June 2026, up 19% year on year
CEO / Leadership	Andrew Dudum, co-founder and Chief Executive Officer since September 2016; Oluyemi "Yemi" Okupe, Chief Financial Officer; Dr Patrick Carroll, Global Chief Medical Officer
Employees	2,442 as at 31 December 2025 per the FY2025 Form 10-K, up around 49% year on year. This predates the Eucalyptus acquisition completed on 2 June 2026, and no post-acquisition figure has been disclosed.
Shares outstanding	233,297,933 at 30 June 2026 (224,920,310 Class A plus 8,377,623 Class V)
Dividend	None. Hims & Hers has never paid a dividend.
Fiscal year end	31 December

Cross-reference: this report also links to the ChartsView Live Charts tool and the Economic Calendar.

2. The Bull and Bear Case

Bull Case

Growth re-accelerated hard in the June quarter: revenue rose 38% to $753.2m in Q2 2026 after only 4% growth in Q1 2026, and management raised full-year 2026 revenue guidance from $2.8–3.0bn to $3.1–3.3bn. Subscribers reached 2.891 million, up 19%.
International is now material and growing from nothing: rest-of-world revenue was $131.4m in Q2 2026 against $7.5m a year earlier, and is 17.4% of group revenue. Management expects at least $600m of international revenue in 2026, with the United Kingdom, Australia and Germany each above a $100m annualised run rate.
Unit economics are improving even as gross margin falls: monthly revenue per average subscriber rose from $76 to $92, up 21%, while marketing fell from 40.0% to 34.8% of revenue. The company is extracting more from each customer while spending proportionally less to acquire them.
The Novo Nordisk relationship has been repaired and made commercial: on 9 March 2026 Hims announced access to branded Ozempic and Wegovy injections and tablets, and Novo simultaneously dismissed its patent lawsuit. The single largest overhang from 2025 has been converted into a supply arrangement.
Vertical integration is real and on the balance sheet: property, equipment and software stood at $364.2m at 30 June 2026, reflecting owned pharmacy and fulfilment capacity, a California peptide manufacturing facility and the Trybe Labs and YourBio diagnostics assets — an unusually heavy asset base for a business often described as pure telehealth.

Bear Case

The Federal Trade Commission is suing the subscription model itself: the complaint filed on 29 July 2026 attacks health-data sharing with advertising platforms, cancellation flows, and charging customers before they have spoken to a provider. It seeks permanent injunctive relief, monetary relief, disgorgement and civil penalties. The shares fell 14.73% on the day.
Profitability has reversed: gross margin fell from 76% in Q2 2025 to 64% in Q2 2026 and from 74% for FY2025, and the company reported net losses of $92.1m and $86.3m in the two 2026 quarters against profits of $49.5m and $42.5m a year earlier. The trailing twelve months is a GAAP loss of roughly $142.0m.
The 2030 target requires a step-change nobody has demonstrated: at least $6.5bn of revenue and $1.3bn of Adjusted EBITDA implies a 20% margin against the 9–10% guided for 2026. Reaffirming a target three times is not the same as showing the operating leverage that delivers it.
Debt has replaced a debt-free balance sheet, and dilution is masked: convertible senior notes went from zero at the end of FY2024 to $972.6m at the end of FY2025 and $1,365.3m at 30 June 2026. Because the 2026 quarters are loss-making, all dilutive instruments are antidilutive and drop out of the reported diluted count — which fell from 256.8m to 231.7m shares even as the underlying obligation grew.
Manufacturer disintermediation is the structural threat: Eli Lilly launched its oral GLP-1 Foundayo across LillyDirect, Amazon Pharmacy, GoodRx, Ro and WeightWatchers on 9 April 2026 — pointedly not through Hims — and Lilly has stated it has no affiliation with the company. Novo runs its own NovoCare Pharmacy channel. Amazon bundled screening, prescription, monitoring and delivery through One Medical in April 2026.

3. Revenue Segments

Hims & Hers reports a single operating segment. The disaggregation it publishes changed in 2026: through FY2025 the company split revenue into Online and Wholesale, and from Q1 2026 it discloses only United States versus Rest of the World. Both are set out below, each on its own basis.

Segment / category	% of revenue	What it is
United States	82.6% in Q2 2026 ($621.8m); 94.3% for FY2025	The core direct-to-consumer subscription business across all specialties. Grew 16% year on year in Q2 2026 after declining 8% in Q1 2026 on the weight-loss transition.
Rest of the world	17.4% in Q2 2026 ($131.4m); 5.7% for FY2025	United Kingdom, Germany, France, Ireland, Spain, Canada, Australia and Japan, assembled through the ZAVA, Medici and Eucalyptus acquisitions. Up more than sixteenfold year on year.
Online revenue	98.5% of FY2025 ($2,311.4m); disclosure discontinued from 2026	Subscription revenue billed directly to consumers on a recurring 30 or 90-day cadence, net of refunds, credits and chargebacks.
Wholesale revenue	1.5% of FY2025 ($36.2m); disclosure discontinued from 2026	Non-prescription product sold to retailers and third-party platforms. Shrinking in absolute terms, from $38.6m in FY2024.

The company does not publish a revenue breakdown by specialty. What management has disclosed is that personalised offerings represented over 70% of United States revenue in 2025, against roughly half in 2024; that the Hers brand is on track to exceed $1bn of revenue in 2026; and that testosterone is the fastest-growing specialty outside weight loss and is expected to become the sixth United States specialty above a $100m annual run rate. Any specialty-level revenue table circulating elsewhere is a third-party estimate, not a company disclosure.

4. Business Model and Moat

How it makes money. A customer completes an online intake, is connected to a licensed provider through an affiliated professional medical corporation, and where a prescription is issued receives medication on an automatically billed recurring cadence. Around 98–99% of revenue is this online subscription flow. The company's own definition is explicit that subscribers are customers who have agreed to be automatically billed on a recurring basis at a defined cadence — which is precisely the mechanic the Federal Trade Commission's negative-option claims are aimed at.

Where the defensibility is claimed to sit. Vertical integration is the central argument. Hims owns and operates affiliated pharmacy and fulfilment facilities, a California peptide manufacturing plant acquired in February 2025, the Trybe Labs at-home testing facility acquired the same month, and YourBio Health's capillary blood-sampling technology. Owning the pharmacy lets the company control cost, formulation and delivery in a way a pure marketplace cannot, and $364.2m of property, equipment and software at 30 June 2026 is the balance-sheet evidence of it.

Personalisation, and its limits. The stated differentiator has been dosing and formulation tailored per patient. That claim carried the compounded-GLP-1 business through 2025, and it is also exactly what Novo Nordisk attacked in June 2025 as a false guise for mass compounding. After the 9 March 2026 strategic shift the personalisation pitch has migrated toward the flexible dosing and form factors already available within the branded assortment — a narrower and more durable version of the same argument.

The AI layer is the 2026 narrative. Since April 2026 the company has framed AI as the operating system for care: Labs AI launched on 7 May 2026, a rebuilt Hers app with a doctor-led AI-native care experience and a connected smart scale on 6 August 2026, and the Chief Financial Officer attributes meaningful cost efficiencies to it. Whether that constitutes a moat or a user interface is not yet answerable from the filings.

5. Financial Health

All figures below are taken from the company's own earnings releases and Form 10-K and 10-Q filings, and from its XBRL company facts on SEC EDGAR. Hims & Hers publishes Adjusted EBITDA and adjusted net income but does not publish an adjusted earnings per share figure.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	271.9	+82.8%	$(0.58)	$(0.58) †	Nil	$0m
FY2022	526.9	+93.8%	$(0.32)	$(0.32) †	Nil	$0m
FY2023	872.0	+65.5%	$(0.11)	$(0.11) †	Nil	$0m
FY2024	1,476.5	+69.3%	$0.53	$0.53 †	Nil	$0m
FY2025	2,347.6	+59.0%	$0.51	$0.51 †	Nil	$972.6m

† Hims & Hers does not report an adjusted earnings per share figure. It reports Adjusted EBITDA of $(30.1)m, $(15.8)m, $49.5m, $176.9m and $318.0m for FY2021 to FY2025 respectively, and adjusted net income separately. The GAAP figure is repeated so the column is not left blank. ‡ The long-term debt column is convertible senior notes, net, per the XBRL tag ConvertibleDebtNoncurrent. The company was genuinely debt-free through FY2024; it issued $1.0bn of 0.00% convertible senior notes due 15 May 2030 in May 2025 and approximately $402.5m of 0.00% convertible notes due 2032 in May 2026, taking the carrying value to $1,365.3m at 30 June 2026.

Quarter / Half	Revenue ($m)	Adjusted EPS	GAAP EPS
Q2 2026 (to 30 Jun 2026)	753.2	$(0.37) †	$(0.37)
Q1 2026 (to 31 Mar 2026)	608.1	$(0.40) †	$(0.40)
Q4 2025 (to 31 Dec 2025)	617.8	$0.08 †	$0.08
Q3 2025 (to 30 Sep 2025)	599.0	$0.06 †	$0.06
FY2025 total	2,347.6	$0.51 †	$0.51

The corresponding Adjusted EBITDA figures are $60.3m for Q2 2026, $44.3m for Q1 2026, $66.3m for Q4 2025 and $78.4m for Q3 2025, giving $249.3m for the trailing twelve months against $318.0m for FY2025. The swing to a GAAP loss in Q2 2026 is largely identifiable: legal contingencies of $47.5m in the quarter and $62.5m for the half, acquisition and transaction costs of $28.8m, restructuring of $4.6m, and depreciation and amortisation tripling to $29.5m on the Eucalyptus intangibles. General and administrative expense rose from $67.3m to $165.4m year on year. Separately, Q1 2026 absorbed a $28.5m non-cash inventory write-down inside cost of revenue as the compounded-GLP-1 inventory was written off.

On cash: FY2025 operating cash flow was $300.0m against capital expenditure of $242.6m, giving free cash flow of $57.4m. For the trailing twelve months to 30 June 2026, operating cash flow was $263.5m and capital expenditure $201.8m, giving free cash flow of approximately $61.7m. The first half of 2026 was free-cash-flow negative at minus $15.2m. At 30 June 2026 the company held $609.8m of cash and $231.2m of short-term investments against $1,365.3m of convertible notes; total stockholders' equity had fallen from $540.9m at the end of 2025 to $324.1m, and goodwill had risen from $278m to $1,101.7m on the Eucalyptus acquisition. A further $537.4m of current and $165.6m of non-current deferred acquisition payable, plus $81.4m current and $81.6m non-current earn-out consideration, sits on the balance sheet as the unpaid portion of that deal.

6. Valuation Metrics

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

Metric	Value
Market cap	~$6.64bn at $28.44 per share, the close on 1 September 2026, across 233.3m Class A and Class V shares
Trailing P/E (GAAP)	n/m — the trailing twelve months to 30 June 2026 produced a GAAP net loss of approximately $142.0m (Q3 2025 +$15.8m, Q4 2025 +$20.6m, Q1 2026 −$92.1m, Q2 2026 −$86.3m), so there are no trailing earnings to capitalise. On FY2025 GAAP diluted EPS of $0.51 the historic multiple would have been ~55.8x. The company publishes no adjusted EPS.
P/E (forward)	~28.4x on a consensus forward EPS of approximately $1.00. Hims & Hers guides revenue and Adjusted EBITDA only and issues no EPS guidance, so this is a third-party consensus input rather than a company figure.
P/S (TTM)	2.57x (market cap ~$6.64bn / trailing twelve-month revenue $2,578.1m, being Q3 2025 $599.0m + Q4 2025 $617.8m + Q1 2026 $608.1m + Q2 2026 $753.2m)
Enterprise value	~$7.16bn (market cap ~$6.64bn + convertible senior notes $1,365.3m − cash $609.8m and short-term investments $231.2m, per the 30 June 2026 balance sheet). Treating the $703.0m of deferred acquisition payable and $163.0m of earn-out consideration as debt-like would take enterprise value to roughly $8.0bn.
EV/EBITDA (TTM)	n/m on a GAAP basis — trailing operating income is a loss of approximately $154.5m, which even after adding back $87.2m of depreciation and amortisation leaves EBITDA negative at roughly −$67.3m. On the company's own Adjusted EBITDA of $249.3m for the trailing twelve months the multiple is ~28.7x, and on the $300m midpoint of 2026 guidance it is ~23.9x. Adjusted EBITDA excludes stock-based compensation, the $62.5m of legal contingencies and $38.1m of restructuring charges booked in the first half.
P/FCF	~108x (market cap ~$6.64bn / free cash flow ~$61.7m; free cash flow = trailing operating cash flow $263.5m − capital expenditure $201.8m). On FY2025 free cash flow of $57.4m the multiple would be ~116x. The first half of 2026 was free-cash-flow negative.
52-week high	$65.30
52-week low	$13.74
Short interest (% of float)	~27.5% — 58,674,597 shares short at the 14 August 2026 settlement date against a float of 213,682,422 shares. One of the most heavily shorted mid-caps on the New York Stock Exchange, though down from a reported peak of roughly 43% of float earlier in 2026.
Days to cover	~4.0 days on the trailing average daily volume used by the primary data provider; a second provider computes 5.51 days for the same 14 August 2026 settlement. Either figure implies genuine two-way squeeze risk on news.

7. What Are They Building

An international platform, bought rather than built. The 2025 and 2026 acquisitions are the strategy. ZAVA, completed by 9 July 2025, brought the United Kingdom, Germany, France, Ireland and Spain. Medici Technologies, acquired in November 2025, brought Canada. Eucalyptus, announced in February 2026 at $1.15bn and completed on 2 June 2026, brought Australia and Japan and deepened the United Kingdom, Germany and Canada. The Hims brand launched to Australian consumers on 31 August 2026, the first visible commercial output of that deal.

Diagnostics as an acquisition funnel. Trybe Labs, a New Jersey at-home lab-testing facility acquired in February 2025, and YourBio Health's capillary whole-blood sampling technology underpin the Labs by Hims & Hers product launched on 13 November 2025 and the Labs AI care agent launched on 7 May 2026. The logic is that a cheap whole-body test both acquires the customer and identifies which specialties to sell them.

Peptides. The California peptide manufacturing facility acquired in February 2025 is a manufacturing asset whose value depends directly on how the Food and Drug Administration regulates peptide therapy. The company has published three policy posts on the subject in 2026 — applauding regulatory clarity in April, welcoming progress on a safer access pathway in July, and defending peptides as a class the same month. This is an open regulatory front with a plant attached to it.

Generic GLP-1 arbitrage. On 21 May 2026 Hims launched access to generic semaglutide for Canadian customers, following it on 29 May with a price reduction. Canada was chosen explicitly as one of the first markets expected to have generic semaglutide. As patents expire in other jurisdictions the same play becomes available — a lawful version of the compounding economics the company lost in the United States.

8. Competitive Position

Peer	Market cap (September 2026)	Key 2025/2026 metric
Eli Lilly (LLY)	~$1,034bn	Launched the oral GLP-1 Foundayo across the United States from 9 April 2026 through LillyDirect, Amazon Pharmacy, GoodRx, Ro and WeightWatchers. Lilly has stated it has no affiliation with Hims & Hers. Trailing twelve-month revenue $79.7bn.
Novo Nordisk (NVO)	~$199bn	Trailing twelve-month revenue $329.4bn Danish kroner equivalent as reported by the data provider. Runs NovoCare Pharmacy, its own direct-to-consumer self-pay channel, while simultaneously supplying branded Ozempic and Wegovy to the Hims platform under the 9 March 2026 arrangement.
Teladoc Health (TDOC)	~$1.14bn	Trailing twelve-month revenue $2.49bn, marginally below Hims & Hers on a comparable basis, but contracting: revenue declined roughly 2% year on year in Q2 2026. The incumbent telehealth platform, now smaller by market value than Hims by a factor of nearly six.
LifeMD (LFMD)	~$149m	Q2 2026 revenue $47.3m with a GAAP loss of $(0.16) per share, and full-year 2026 guidance cut to revenue of $205.5–212.5m and Adjusted EBITDA of minus $6.0m to breakeven, from $220–230m and plus $12–17m previously.
Amazon (AMZN)	~$2,750bn	Bundled GLP-1 screening, prescription, monitoring and pharmacy delivery through One Medical in April 2026, with same-day delivery in nearly 3,000 areas expanding to 4,500 municipalities by the end of 2026. Also the fulfilment partner for LillyDirect home delivery.
Ro	Private — last disclosed valuation $7bn (February 2022)	A distribution partner for Eli Lilly's Foundayo through LillyDirect from 9 April 2026, a channel Hims & Hers does not have. Approximately $1.03bn raised in total.

The competitive read in 2026 is that the threat is not other telehealth start-ups — Teladoc is shrinking and LifeMD has just cut guidance — but manufacturer disintermediation. Novo and Lilly both now sell direct to patients, and Amazon has bundled the entire stack from screening to delivery. Hims & Hers' answer is scale, international breadth and an AI-native experience rather than price. WeightWatchers, which filed a prepackaged Chapter 11 in May 2025 and emerged as a private entity on 24 June 2025 having eliminated $1.15bn of debt, is also now a LillyDirect distribution partner.

9. Insider Activity

Chief Executive Andrew Dudum remains the company's largest individual holder, with roughly 8.23 million shares across direct and trust holdings after the August 2026 transfers. Insider activity in 2026 is entirely one-directional: zero open-market purchases by any insider, and every discretionary sale executed under a Rule 10b5-1 plan. The two very large August movements by Dudum are estate-planning transfers at zero consideration, not sales, and should not be read as selling.

Name	Date	Type	Shares	Price	Value	Plan Type
Andrew Dudum, CEO and Director	27 Aug 2026	Trust distribution (J)	977,566 Class A	Nil	Nil — no consideration	Not under a plan; estate planning
Andrew Dudum, CEO and Director	25 Aug 2026	Bona fide gift (G)	463,289 Class A	Nil	Nil — no consideration	Not under a plan; estate planning
Soleil Boughton, Chief Legal Officer	19 Aug 2026	Sale (S)	25,111 Class A	$27.55	$691,808	Rule 10b5-1 adopted 21 May 2026
Oluyemi Okupe, CFO	19 Aug 2026	Option exercise and sale (M/S)	4,938 Class A	$29.99 weighted average	$148,092	Rule 10b5-1 adopted 21 May 2025
Deborah Autor, Chief Policy Officer and Director	18 Aug 2026	Sale (S)	16,773 Class A	$27.85	$467,128	Rule 10b5-1 adopted 20 May 2026
Andrew Dudum, CEO and Director	14 Aug 2026	Tax withholding on vesting	78,859 Class A	~$27.90	~$2.2m	Non-discretionary
Oluyemi Okupe, CFO	17 Jul 2026	Option exercise and sale (M/S)	7,163 Class A	$31.99 weighted average	$229,167	Rule 10b5-1 adopted 21 May 2025
Dr Patrick Carroll, Global Chief Medical Officer	18 Jun 2026	Sale (S)	23,726 Class A	$35.00	$830,410	Rule 10b5-1

The realised prices trace the year: $36.49 on 6 July, $31.99 on 17 July, then $27.55 to $30.00 across 18 and 19 August. Insiders have been selling into a falling tape under plans adopted in May, before the Federal Trade Commission action. One governance point is worth flagging alongside this: Chief Accounting Officer Irene Becklund is departing in October 2026, with Chief Financial Officer Yemi Okupe assuming those responsibilities on an interim basis, at the same time as an SEC enforcement investigation into the company's disclosures is live.

10. Key Risks

Material litigation and enforcement: the Federal Trade Commission, joined by the State of Utah and Los Angeles County on behalf of the People of California, filed suit in the Northern District of California on 29 July 2026 seeking a permanent injunction, monetary relief, disgorgement of profits and civil penalties under Section 5 of the FTC Act and the Restore Online Shoppers' Confidence Act. Running alongside it are an SEC Division of Enforcement investigation into the company's disclosures on compounded semaglutide, disclosed in the FY2025 Form 10-K, and a Department of Justice referral announced by the Department of Health and Human Services General Counsel in February 2026. Together these attack the subscription billing mechanic, the data practices and the public statements simultaneously.
Regulatory closure of the compounding pathway: the Food and Drug Administration issued more than 50 warning letters to telehealth firms and compounders in March 2026 and has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B Bulks List, with the comment docket closed on 29 June 2026. If finalised, large-scale compounding of all three molecules is permanently foreclosed.
Payment-processor sanction: Hims & Hers was enrolled in Visa's Acquirer Monitoring Program in August 2026 after July card-dispute rates in the weight-loss subscription business breached Visa's 1.5% threshold. The weight-loss business generated 75% of disputes. The company must hold below the threshold for three consecutive months to exit, and pays an $8 surcharge per dispute.
Margin compression is structural, not one-off: gross margin has fallen from 82% in FY2023 to 79%, then 74%, then 64% in Q2 2026. Selling branded Novo GLP-1s at prices matching other telehealth firms is a materially lower-margin activity than compounding was, and the mix is shifting toward it.
Integration and acquisition risk: goodwill quadrupled to $1,101.7m in six months on the $1.15bn Eucalyptus deal, against total stockholders' equity of $324.1m. A further $703.0m of deferred acquisition payable and $163.0m of earn-out consideration remains unpaid. An impairment against that goodwill would exceed the entire equity base.
Supplier concentration and counterparty history: the branded GLP-1 supply that now underpins the United States weight-loss business comes from a counterparty that publicly accused the company of illegal mass compounding and deceptive marketing in June 2025 and sued it for patent infringement in February 2026. That suit was dismissed without prejudice, meaning it can be refiled.
Securities class-action exposure: putative class actions filed in 2025 on behalf of purchasers between 29 April and 23 June 2025 remain in active litigation with no class certified and no settlement announced, and a fresh wave of investigations opened after the FTC filing, including a Pomerantz investor alert dated 1 September 2026.
Dilution obscured by loss-making periods: $1,365.3m of zero-coupon convertible notes and outstanding equity awards drop out of the reported diluted share count while the company is loss-making, which is why the diluted count fell from 256.8m to 231.7m shares year on year. The obligation has not gone away; only its visibility in the earnings-per-share denominator has.

11. Recent Developments

09 Mar 2026 — Strategic shift on United States weight loss, and peace with Novo Nordisk. Hims announced access to branded Ozempic and Wegovy injections and tablets, agreed to stop advertising compounded GLP-1s entirely, and Novo Nordisk simultaneously dismissed its patent lawsuit without prejudice.
23 Apr 2026 — Full range of FDA-approved GLP-1s live on the platform. Completion of the March transition, with the branded assortment fully available.
07 May 2026 — Labs AI launched. The company's first AI care agent, layered on the diagnostics business built from the Trybe Labs and YourBio acquisitions.
11 May 2026 — Q1 2026 results. Revenue of $608.1m grew only 4%, the company reported its first quarterly GAAP loss in years at $(92.1)m or $(0.40) per share, gross margin fell to 65%, and full-year revenue guidance was nonetheless raised to $2.8–3.0bn. The company also moved from a quarterly to an annual shareholder letter.
21 May 2026 — Generic semaglutide launched in Canada. Followed on 29 May by a price reduction, exploiting Canada's earlier patent expiry.
02 Jun 2026 — Eucalyptus acquisition completed for $1.15bn. Adds Australia and Japan and deepens the United Kingdom, Germany and Canada. Goodwill quadrupled to $1.10bn as a result.
29 Jul 2026 — Federal Trade Commission sues, and the shares fall 14.73%. The FTC, Utah and Los Angeles County filed in the Northern District of California over health-data sharing with Meta and Snap, obscured cancellation flows, and charging customers before a provider consultation. The stock closed at $25.00.
06 Aug 2026 — New Hers app launched. A doctor-led, AI-native care experience including an AI-powered weight-loss programme with a connected smart scale.
10 Aug 2026 — Q2 2026 results and a guidance raise. Revenue of $753.2m grew 38%, subscribers reached 2.89 million, Adjusted EBITDA was $60.3m and the net loss $(86.3)m. International revenue rose more than sixteenfold to $131.4m and full-year guidance was raised to $3.1–3.3bn.
24 Aug 2026 — Visa places the company under monitoring. Enrolment in the Acquirer Monitoring Program after July card-dispute rates in weight-loss subscriptions exceeded Visa's threshold, with roughly $75,000 of surcharges falling due in September. The shares slumped.
31 Aug 2026 — Hims launches to consumers in Australia. The first visible commercial output of the Eucalyptus acquisition.
01 Sep 2026 — A fresh securities-litigation front opens. Pomerantz LLP issued an investor alert announcing an investigation of claims on behalf of Hims & Hers investors, joining several other firms with open investigations following the FTC action.

12. Key Dates to Watch

Expected Sep 2026 — first Visa dispute-surcharge invoice of approximately $75,000 falls due, and the first of three consecutive months in which the card-dispute rate must be held below 1.5% for the company to exit the Acquirer Monitoring Program
Expected Oct 2026 — the customary press release confirming the Q3 2026 reporting date, on the pattern of the 13 October 2025 announcement for the Q3 2025 results. Chief Accounting Officer Irene Becklund also departs during October 2026.
Expected Nov 2026 — Q3 2026 results. Third-party earnings calendars indicate around 9 November 2026; this is a consensus estimate and has not been confirmed by the company. Q3 2025 was reported on 3 November 2025. Guidance for the quarter is revenue of $880–900m and Adjusted EBITDA of $75–95m.
Expected Feb 2027 — Q4 and FY2026 results and the FY2026 Form 10-K, on the pattern of the 23 February 2026 release. This is now also the annual shareholder letter, following the move away from quarterly letters announced in May 2026.
15 Nov 2029 — holders of the $1.0bn of 0.00% convertible senior notes may convert at will from this date
15 May 2030 — maturity of the $1.0bn of 0.00% convertible senior notes; a further approximately $402.5m of 0.00% notes mature in 2032
TBD — case-management and hearing dates in FTC v. Hims & Hers Health, Inc. in the Northern District of California, filed 29 July 2026. No schedule has been published.
TBD — final Food and Drug Administration determination on excluding semaglutide, tirzepatide and liraglutide from the 503B Bulks List. The comment docket closed on 29 June 2026 and no decision date has been announced.

Three matters are open-ended with no timetable disclosed: the SEC Division of Enforcement investigation, on which the company states it is unable to predict when or how the matter will be concluded; the Department of Justice referral; and class certification in the 2025 securities actions. The deferred acquisition payable and earn-out consideration from the Eucalyptus deal also have no disclosed settlement dates. Readers tracking the schedule may find the ChartsView Economic Calendar useful, and discussion continues on the ChartsView Forum.

Last Updated: 6 September 2026

Rocket Pharmaceuticals is a Cranbury, New Jersey gene-therapy developer that spent eight years and roughly $1.4bn of cumulative losses getting a first medicine approved — and reached that milestone in March 2026 with a market capitalisation of under half a billion dollars. The company sits at an unusual junction. It now owns an FDA-approved therapy, KRESLADI, and has already converted the priority review voucher that came with it into $180m of cash. It has also just restarted the pivotal trial that a patient death shut down in May 2025, with three patients through the safety window and no repeat of the complication. Against that, it still recognises no revenue at all, burns roughly $170m a year, and trades at an enterprise value materially below the cash on its balance sheet. This report sets out what the filings say, without opinions on whether the shares are cheap.

1. Company Snapshot

Field	Value
Legal name	Rocket Pharmaceuticals, Inc.
Ticker / exchange	RCKT, Nasdaq Global Market
Headquarters	Cranbury, New Jersey, United States
Sector	Healthcare — clinical-stage gene therapy (AAV and lentiviral)
Market cap	~$424m (109.8m shares at the $3.86 close on 4 September 2026)
Revenue (FY2025)	$0m — no revenue recognised in any year since 2018
Net loss (FY2025)	$223.1m, or $(2.01) per diluted share
Cash and investments	$283.7m at 30 June 2026; runway guided into Q2 2028
Borrowings	Nil. No debt outstanding since 2021
Employees	202 full-time at 31 December 2025 (195 US, 6 Spain, 1 Italy)
CEO / Leadership	Gaurav Shah, M.D., co-founder and Chief Executive Officer since January 2018; Aaron Ondrey, Chief Financial Officer since March 2024
Approved products	One — KRESLADI (marnetegragene autotemcel), accelerated approval 27 March 2026

Sources: Rocket Pharmaceuticals FY2025 Form 10-K (filed 26 February 2026), Q2 2026 results release (10 August 2026), and SEC XBRL company facts.

2. Bull Case and Bear Case

Bull Case

An approval finally in hand: KRESLADI received FDA accelerated approval on 27 March 2026 for paediatric severe leukocyte adhesion deficiency-I, after a June 2024 complete response letter on manufacturing. Eight years of platform work now has a regulatory precedent behind it.
The voucher was monetised immediately: the rare paediatric disease priority review voucher awarded on approval was sold for $180m gross, closing 12 June 2026. That is non-dilutive cash worth roughly 42% of the entire current market capitalisation.
Danon is back on track with clean safety: all three patients dosed under the modified Phase 2 protocol at the recalibrated 3.8x10^13 GC/kg dose completed the protocol-defined observation period with no thrombotic microangiopathy and no capillary leak syndrome — the exact complication that caused the May 2025 hold.
Enterprise value below net cash: with $283.7m of cash and investments, no borrowings and a $424m market capitalisation, the enterprise value is roughly $140m. The market is currently attributing very little to an approved product plus four clinical programmes.
Cost base cut hard and runway extended: the July 2025 reorganisation removed about 30% of staff; FY2025 R&D fell to $142.0m from $171.2m and G&A to $86.5m from $102.0m. Guided runway moved from "into Q2 2027" in February 2026 to "into Q2 2028" by August 2026.

Bear Case

Still no revenue whatsoever: the income statement has shown $0 of revenue every year from 2018 through 2025, and KRESLADI patient onboarding is not expected to begin until Q4 2026. LAD-I is an ultra-rare condition, so even a successful launch will not produce meaningful scale.
Danon is not de-risked, only restarted: Rocket is still "engaging the FDA" on dosing additional patients. Three patients is a small safety sample, and a further serious adverse event in the lead programme would be difficult to recover from.
The AAV sector is in a sentiment downturn: Sarepta's Elevidys deaths, the FDA's suspension request and its revocation of Sarepta's platform-technology designation have chilled investor appetite for adeno-associated virus gene therapy across the board through 2025 and 2026.
Burn still exceeds the balance sheet on a two-year view: trailing twelve-month operating cash outflow was $170.3m against $283.7m of cash. A $100m at-the-market equity facility with Cantor Fitzgerald was put in place in March 2026, and at a $3.86 share price any use of it is heavily dilutive.
Optionality was deliberately narrowed: the Fanconi anaemia programme lost its EU marketing application in July 2025 and its US biologics licence application in October 2025, and the pyruvate kinase deficiency programme was deprioritised. Two late-stage shots on goal were removed to fund the cardiovascular platform.

3. Revenue Segments

Rocket manages the business as a single operating segment and recognises no revenue, so the table below sets out the therapeutic categories the company reports against rather than a revenue split. Every line is currently 0% of revenue.

Segment / category	% of revenue	What it is
AAV cardiovascular platform	0% — no revenue recognised	The company's declared strategic priority since July 2025. Adeno-associated virus therapies delivered by intravenous infusion for inherited cardiomyopathies: RP-A501 (Danon disease), RP-A601 (PKP2-ACM) and RP-A701 (BAG3-DCM).
Lentiviral haematology — commercial	0% — no revenue recognised	KRESLADI (marnetegragene autotemcel), the approved ex vivo lentiviral therapy for paediatric severe LAD-I. Commercial availability and patient onboarding anticipated to begin in Q4 2026 through a limited network of qualified treatment centres.
Lentiviral haematology — deprioritised	0% — no revenue recognised	RP-L102 for Fanconi anaemia (both regulatory filings withdrawn in 2025, partnering under consideration) and RP-L301 for pyruvate kinase deficiency (Phase 1 complete, RMAT designated, no committed timeline).
Non-operating cash generation	0% — recorded as other income, not revenue	The $180m sale of the KRESLADI priority review voucher, which closed on 12 June 2026 and produced a $178.2m gain in the Q2 2026 income statement. Voucher sales are one-off and are not classified as revenue.

4. Business Model and Moat

How it makes money. Today, it does not. Rocket has no product revenue, no collaboration revenue and no royalty stream. Every dollar spent since 2018 has been funded by equity issuance, and more recently by the one-off $180m voucher sale. The intended model is orphan-drug economics: single-administration curative gene therapies for conditions affecting a few thousand people worldwide, priced in the seven figures per patient and delivered through a small number of specialist treatment centres. KRESLADI is the first test of whether that model closes for Rocket.

What the moat is supposed to be. Two things. First, manufacturing: Rocket built its own 50,000 sq ft AAV cGMP facility inside a 103,720 sq ft Cranbury campus, which matters because the June 2024 complete response letter on KRESLADI was a chemistry-and-manufacturing rejection, not an efficacy one. Owning the process is what allowed the resubmission. Second, disease selection: the company deliberately targets monogenic conditions where the causal gene is unambiguous and there is either no approved therapy or only a transplant option, which limits the number of competitors willing to invest.

Why the moat is contested. Regulatory precedent in AAV gene therapy is not owned by anyone, and the FDA demonstrated in 2025 that a platform-technology designation can be revoked. Rocket's remaining defensive asset is therefore its data and its manufacturing know-how rather than any structural barrier. In practice, the binding constraint is capital: a clinical-stage company with a two-year cash runway competes for the same rare-disease patients as Ultragenyx and Krystal Biotech, both of which already fund development from product revenue.

5. Financial Health

Rocket has never recognised revenue. The annual series below is therefore a loss-and-liquidity table rather than a growth table, and the per-share figures are the meaningful line. All figures are taken from the company's own results releases and from SEC XBRL company facts filed with the Form 10-K.

Fiscal Year	Revenue ($m)	YoY %	GAAP EPS	Adjusted EPS	Dividend/share	Long-term debt (YE)
FY2021	$0m	n/a	$(2.67)	$(2.67)†	Nil	$0m‡
FY2022	$0m	n/a	$(3.26)	$(3.26)†	Nil	$0m‡
FY2023	$0m	n/a	$(2.92)	$(2.92)†	Nil	$0m‡
FY2024	$0m	n/a	$(2.73)	$(2.73)†	Nil	$0m‡
FY2025	$0m	n/a	$(2.01)	$(2.01)†	Nil	$0m‡

† Rocket publishes no adjusted or non-GAAP earnings measure in any period. The GAAP figure is repeated so the column is not left blank.

‡ Rocket has had no borrowings outstanding since its convertible notes were extinguished during 2021 (the XBRL convertible-note balance falls to zero at 30 June 2021 and stays there). The balance sheet does carry a finance-lease obligation on the Cranbury facility of $21.3m at 30 June 2026 and operating-lease liabilities of $3.5m; neither is debt in the borrowing sense. Aggregator "total debt" figures of roughly $24.8m are that lease total.

Quarter / Half	Revenue ($m)	Adjusted EPS	GAAP EPS
Q2 2026 (to 30 Jun 2026)	$0m	$1.08†	$1.08
Q1 2026 (to 31 Mar 2026)	$0m	$(0.42)†	$(0.42)
Q4 2025 (to 31 Dec 2025)	$0m	$(0.38)†	$(0.38)
Q3 2025 (to 30 Sep 2025)	$0m	$(0.45)†	$(0.45)
Q2 2025 (to 30 Jun 2025)	$0m	$(0.62)†	$(0.62)
FY2025 total	$0m	$(2.01)†	$(2.01)

The Q2 2026 profit is entirely non-operating. Reported net income was $123.2m, driven by a $178.2m gain on the priority review voucher sale; underneath it, R&D was $29.5m and G&A $17.4m, both sharply below the $42.7m and $25.0m of Q2 2025. Basic EPS was $1.09 and diluted $1.08. On a trailing twelve-month basis the company remains loss-making at $(0.17) per diluted share, and generated an operating cash outflow of $170.3m against capital expenditure of only $0.1m. Depreciation and amortisation over the same twelve months was $7.6m. Cash and investments moved from $188.9m at 31 December 2025 to $144.4m at 31 March 2026 and then to $283.7m at 30 June 2026 on receipt of the voucher proceeds.

6. Valuation Metrics

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

Metric	Value
Market cap	~$424m (109,774,597 shares at the $3.86 close on 4 September 2026)
Enterprise value	~$140m (market cap ~$424m + borrowings $0m − cash and short-term investments $283.7m per the 30 June 2026 balance sheet). Enterprise value sits below net cash because the equity is capitalised at less than the cash it holds plus a negative value for the burn.
Trailing P/E (GAAP)	n/m — trailing twelve-month diluted EPS is $(0.17), a loss. The only profitable quarter in the series, Q2 2026, was produced by a one-off $178.2m voucher gain rather than by operations.
P/E (forward)	n/m — consensus forward EPS is $(1.30), a loss. Rocket issues no earnings guidance.
P/S (TTM)	n/m — the company recognises no revenue, so the ratio has no denominator.
EV/EBITDA (TTM)	n/m — trailing twelve-month EBITDA is negative $184.0m (operating loss $191.6m plus depreciation and amortisation of $7.6m, the wider cash-flow-statement figure). A negative denominator makes the multiple meaningless.
P/FCF	n/m — trailing twelve-month free cash flow is negative $170.4m (operating cash flow $(170.3)m less capital expenditure of $0.1m). Capital spending has collapsed from $16.4m in FY2023 to $0.4m in FY2025 as the build-out finished.
52-week high	$5.45 intraday; $5.30 on a closing basis
52-week low	$2.53 intraday; $2.60 on a closing basis
Short interest (% of float)	16.4% (14,391,319 shares short against a 87,545,241-share free float), settlement date 14 August 2026. Short interest has roughly doubled as a proportion of the float over the past twelve months.
Days to cover	9.7 days on the same 14 August 2026 settlement, using average daily volume. This is unusually high and reflects thin liquidity rather than a large absolute short position.
Price/book	~1.1x (market cap ~$424m against shareholders' equity of $368.8m at 30 June 2026)

Price action can be followed on the ChartsView Live Charts page.

7. What Are They Building

RP-A501 for Danon disease. The lead asset and the reason the share price is where it is. An AAV9 gene therapy delivered by single intravenous infusion for an X-linked cardiomyopathy that typically kills male patients in their teens or twenties without a heart transplant. On 23 May 2025 the FDA placed the pivotal Phase 2 trial on clinical hold after a treated patient developed capillary leak syndrome with complement activation and subsequently died of an acute systemic infection. Rocket's investigation pointed at a novel immunosuppressive agent that had been added to the pre-treatment regimen specifically for the AAV9 Danon programme. The FDA lifted the hold on 20 August 2025, under three months later, authorising resumption at a recalibrated dose of 3.8x10^13 GC/kg in three sequential patients with a minimum four-week interval and an immunomodulatory regimen closer to the earlier paediatric cohort. All three were dosed and, as disclosed on 10 August 2026, all three cleared the protocol-defined observation window with no thrombotic microangiopathy and no capillary leak syndrome. A global natural history study has now enrolled more than 50 patients.

KRESLADI for LAD-I. Approved on 27 March 2026 under accelerated approval for paediatric patients with severe leukocyte adhesion deficiency-I caused by biallelic ITGB2 variants who lack an HLA-matched sibling donor. This is an ex vivo lentiviral therapy: the patient's own haematopoietic stem cells are harvested, corrected and reinfused. The route to approval was not smooth — the FDA issued a complete response letter in June 2024 over chemistry and manufacturing deficiencies, and the resubmission was only accepted in October 2025 with a 28 March 2026 goal date.

RP-A601 for PKP2-ACM. A Phase 1 AAV programme in plakophilin-2 arrhythmogenic cardiomyopathy, still enrolling to cover a broader severity range. Data presented at the American Society of Gene and Cell Therapy meeting in May 2025, from an April 2025 cutoff, showed increased PKP2 protein expression on cardiac biopsy in all three initial patients, improved desmosomal localisation, directional improvements in arrhythmia measures and right-ventricular function, and no dose-limiting toxicities through up to twelve months of follow-up. An FDA update on pivotal study design is guided for the second half of 2026.

RP-A701 for BAG3 dilated cardiomyopathy. The newest programme, using an AAVrh.74 capsid. The IND was cleared in 2025 and screening is under way for a multicentre dose-escalation study in adults; first patient dosing is now guided for the second half of 2026, having previously been indicated for mid-2026. BAG3-associated dilated cardiomyopathy is estimated to affect around 30,000 people in the United States with no disease-specific approved therapy. The programme arrived with the December 2022 acquisition of Renovacor and its Temple University licence.

What is no longer being built. RP-L102 for Fanconi anaemia lost its European marketing authorisation application in July 2025 and its US biologics licence application in October 2025, in both cases by voluntary withdrawal for strategic rather than safety reasons; Rocket says it will consider external partnerships. RP-L301 for pyruvate kinase deficiency completed Phase 1 with RMAT designation and encouraging haemoglobin responses in the paediatric cohort, but carries no committed development timeline.

8. Competitive Landscape

Peer	Market cap (September 2026)	Key 2025/2026 metric
Krystal Biotech (KRYS)	~$10.6bn	Trailing revenue of ~$440m from VYJUVEK, the approved topical gene therapy for dystrophic epidermolysis bullosa. The clearest illustration of what a commercialised rare-disease gene therapy is worth relative to a pre-revenue one.
uniQure (QURE)	~$3.1bn	Trailing revenue of ~$19m. The nearest large AAV-focused pure-play, with programmes in Huntington's disease and haemophilia B; valued at more than seven times Rocket on a comparable pre-commercial revenue base.
Beam Therapeutics (BEAM)	~$3.1bn	Trailing revenue of ~$156m, almost all collaboration income. A base-editing platform company rather than a conventional AAV developer, included as the benchmark for what platform optionality is priced at.
Sarepta Therapeutics (SRPT)	~$2.4bn	Trailing revenue of ~$1.97bn, yet capitalised at under 1.3x sales after the FDA requested suspension of Elevidys distribution, placed limb-girdle trials on hold following three patient deaths, revoked the company's platform-technology designation, and the company cut roughly 36% of staff.
Ultragenyx Pharmaceutical (RARE)	~$1.5bn	Trailing revenue of ~$717m across multiple approved rare-disease products. A diversified commercial rare-disease company now capitalised at roughly twice Rocket's cash balance.

The read-across from Sarepta matters more than the individual comparisons. A company with nearly $2bn of revenue trading at 1.3 times sales tells you what the market currently pays for AAV gene-therapy risk after a cluster of patient deaths. Rocket's own clinical hold arrived in the same window, and its equity has re-rated to an enterprise value below net cash as a result. Set against that, Krystal at roughly 24 times sales shows the sector is not uniformly derated — commercialised, safe and growing is still valued generously.

9. Insider Activity

Chief Executive Gaurav Shah, who co-founded Rocket and has led it since January 2018, is the only named officer with disclosed 2026 Form 4 activity found in this review. All of the transactions below are dispositions connected to equity compensation rather than discretionary open-market selling: two are shares withheld or sold to satisfy tax on restricted stock unit vesting, and the third covers the exercise cost and tax on an option exercise that simultaneously increased his holding by 76,490 shares. No open-market purchases by any insider were identified.

Name	Date	Type	Shares	Price	Value	Plan Type
Gaurav Shah (CEO)	18 Aug 2026	Disposition	2,293	$3.381	~$7,753	RSU tax withholding
Gaurav Shah (CEO)	13 Aug 2026	Disposition	2,837	$3.381	~$9,592	RSU tax withholding
Gaurav Shah (CEO)	21 May 2026	Sale to cover	55,684	~$3.09	~$171,840	Option exercise cost and tax
Gaurav Shah (CEO)	21 May 2026	Acquisition	76,490	Exercise price	~$129,344	Stock option exercise

Shares outstanding have grown steadily from 106,453,818 at 31 December 2024 to 109,539,424 at 30 June 2026 — a little under 3% over eighteen months, which is modest for a pre-revenue biotech and reflects the fact that the December 2024 offering and pre-funded warrant placement, not 2026 issuance, did the heavy lifting.

10. Key Risks

Liquidity and dilution: Rocket recognises no revenue and burned $170.3m of operating cash over the last twelve months against $283.7m of cash and investments. Guided runway reaches into Q2 2028, which means a financing decision arrives well before the Danon programme could plausibly be approved. A $100m at-the-market facility with Cantor Fitzgerald has been in place since March 2026, and issuing equity near a $3.86 share price would be materially dilutive.
Repeat safety events in the lead programme: the May 2025 patient death produced a three-month clinical hold and a permanent reset of the Danon protocol. Only three patients have been dosed under the revised regimen. A further serious adverse event would very likely end the programme that accounts for most of the equity's optionality.
Regulatory pathway not yet agreed: the FDA lifted the hold but Rocket is still "engaging" the agency on dosing additional patients and completing the pivotal trial. The size, endpoints and duration of that trial are undetermined, and the guided update is only a general commitment to the second half of 2026.
Commercial execution on an ultra-rare indication: KRESLADI treats a condition affecting a very small number of children. Patient onboarding does not begin until Q4 2026, will run through a limited network of qualified treatment centres, and depends on payer reimbursement for a one-time high-cost therapy. Approval does not guarantee uptake.
Sector-wide AAV sentiment and FDA posture: the Sarepta episode showed the FDA is willing to suspend distribution of an approved gene therapy, halt multiple trials and revoke a platform designation. That regulatory temperature applies to Rocket's entire cardiovascular pipeline regardless of its own data.
Concentrated pipeline after the reorganisation: the July 2025 restructuring removed about 30% of the workforce and shelved the Fanconi anaemia and pyruvate kinase deficiency programmes. The company is now effectively a bet on three AAV cardiac assets plus one approved ultra-orphan product.
Thin liquidity and elevated short interest: 16.4% of the free float is sold short with 9.7 days to cover. In a sub-$500m company that combination amplifies moves in both directions and can make orderly financing harder.

11. Recent Developments

10 Aug 2026 — Q2 2026 results and a clean Danon safety readout. Net income of $123.2m ($1.09 basic, $1.08 diluted) driven by the $178.2m voucher gain; R&D down to $29.5m and G&A to $17.4m; cash and investments $283.7m; runway extended to "into Q2 2028". All three patients dosed under the modified RP-A501 protocol cleared the safety observation period with no thrombotic microangiopathy or capillary leak syndrome.
12 Jun 2026 — Priority review voucher sale closes. The rare paediatric disease voucher awarded with the KRESLADI approval was sold for $180m in gross proceeds, transforming the balance sheet without issuing a share.
07 May 2026 — Q1 2026 results. Net loss of $47.6m, or $(0.42) per share; R&D $31.5m; G&A $17.1m; cash and investments down to $144.4m. The definitive agreement to sell the voucher was announced alongside.
27 Mar 2026 — FDA approves KRESLADI. Accelerated approval for marnetegragene autotemcel in paediatric patients with severe LAD-I, delivered on the 28 March 2026 goal date. Rocket's first approved product in eight years as a gene-therapy developer.
26 Feb 2026 — FY2025 results and Form 10-K. Full-year net loss of $223.1m, or $(2.01) per share, down from $258.7m; R&D $142.0m against $171.2m; cash and investments $188.9m; runway then guided only "into Q2 2027". Headcount disclosed at 202 full-time employees.
06 Nov 2025 — Q3 2025 results. Net loss of $50.3m, or $(0.45) per share, with R&D down to $34.1m from $42.3m a year earlier as the restructuring took effect. Rocket also confirmed it had voluntarily withdrawn the US biologics licence application for RP-L102 in Fanconi anaemia on strategic grounds, with no complete response letter involved.
13 Oct 2025 — FDA accepts the KRESLADI resubmission. The agency accepted the resubmitted biologics licence application and set a 28 March 2026 goal date. The filing was supported by Phase 1/2 data showing 100% overall survival at twelve months post-infusion with all primary and secondary endpoints met.
20 Aug 2025 — FDA lifts the RP-A501 clinical hold. Under three months after imposition, with a recalibrated 3.8x10^13 GC/kg dose, sequential dosing of three patients at four-week intervals and a revised immunomodulatory regimen.
24 Jul 2025 — Strategic reorganisation. Roughly 30% of the workforce cut, about 80 people, at a cost of around $3.5m mostly in severance, with twelve-month operating expenses guided down by nearly 25%. The pipeline was reprioritised onto the AAV cardiovascular platform, and the European marketing application for RP-L102 was withdrawn.
23 May 2025 — Clinical hold after a patient death. The FDA halted the pivotal Danon disease trial after a treated patient developed capillary leak syndrome with complement activation and later died of an acute systemic infection. This is the event from which the current share price descends.

12. Key Dates

10 Sep 2026 — Dr Gaurav Shah takes part in a fireside chat at the 2026 Cantor Global Healthcare Conference, 1:00 PM Eastern, webcast via the investor relations site.
15 Sep 2026 — Fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference, 9:15 AM Eastern, with management investor meetings alongside.
Expected 2H 2026 — FDA regulatory-pathway update on RP-A501 covering the dosing of additional Danon patients and completion of the pivotal trial.
Expected 2H 2026 — Investor webinar giving a comprehensive Danon disease programme update, confirmed as on track in the Q2 2026 release.
Expected 2H 2026 — FDA update on the planned pivotal study design for RP-A601 in PKP2-ACM, and first patient dosing in the RP-A701 BAG3-DCM Phase 1.
Expected Nov 2026 — Q3 2026 results. No date has been announced; Q3 2025 was reported on 6 November 2025.
Expected Q4 2026 — KRESLADI commercial availability and the start of patient onboarding through qualified treatment centres.

There is no outstanding PDUFA date for any Rocket programme following the March 2026 KRESLADI approval. Scheduled macro events that move healthcare and small-cap biotech more broadly are listed on the ChartsView Economic Calendar, and readers can discuss this report in the ChartsView Forum.

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