On October 30, 2025 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2025 financial results. Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We delivered another quarter of strong financial performance driven by continued commercial momentum in our launch products, resilience in our MS franchise and our ongoing focus on disciplined cost management. Looking ahead we are further advancing our new Biogen roadmap with a cadence of potentially registrational Phase 3 readouts beginning next year, including data now expected in 2026 from both SLE studies for litifilimab which are fully enrolled. We believe this execution on our strategic objectives, combined with our resilient business model and footprint, positions Biogen to deliver long-term sustainable growth."
Financial Highlights
Q3 ’25 Q3 ’24 △
r (CC*)
Total Revenue (in millions) $2,535 $2,466 3% 2%
GAAP diluted EPS $3.17 $2.66 19% N/A
Non-GAAP diluted EPS $4.81 $4.08 18% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q3 ’25 Q3 ’24 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,062 $1,054 1% —%
Rare disease revenue(2)
$533 $495 8% 6%
Biosimilars revenue $197 $197 —% —%
Other product revenue(3)
$55 $24 129% 130%
Total product revenue $1,847 $1,769 4% 3%
Revenue from anti-CD20 therapeutic programs $494 $446 11% 11%
Alzheimer’s collaboration revenue(4)
$43 $19 130% 129%
Contract manufacturing, royalty and other revenue $151 $232 (35)% (35)%
Total revenue $2,535 $2,466 3% 2%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
NMF = no meaningful figure.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective
January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
2

Expense Summary
(in millions, except effective tax rate) Q3 ’25 Q3 ’24 △
GAAP cost of sales*
$674 $639 (6)%
% of Total Revenue 27% 26%
Non-GAAP cost of sales*
$510 $593 14%
% of Total Revenue 20% 24%
GAAP R&D expense $436 $516 16%
Non-GAAP R&D expense $432 $465 7%
GAAP SG&A expense $595 $588 (1)%
Non-GAAP SG&A expense $592 $556 (6)%
GAAP acquired IPR&D, upfront and milestone expense $2 $27 NMF
Non-GAAP acquired IPR&D, upfront and milestone expense $2 $27 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in third quarter 2025 GAAP cost of sales as a percentage of total revenue was driven primarily by a pre-tax charge related to a judgment on Genentech’s claim for past royalties and interest on sales of TYSABRI, partially offset by favorable product mix, particularly the year-over-year decrease in contract manufacturing revenue. The decrease in third quarter 2025 Non-GAAP cost of sales as a percentage of total revenue was driven primarily by favorable product mix, particularly the year-over-year decrease in contract manufacturing revenue.

•The decrease in third quarter 2025 GAAP and Non-GAAP R&D expense was driven primarily by the favorable impact from the Company’s Fit for Growth initiative and R&D funding received, partially offset by increased investment in late-stage programs including felzartamab and litifilimab.

•The increase in third quarter 2025 GAAP and Non-GAAP SG&A was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•Third quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $2 million.
Other Financial Highlights

•Third quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $87 million, which includes approximately $67 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $21 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. for the commercialization of ZURZUVAE in the U.S.

•Third quarter 2025 GAAP and Non-GAAP other expense was approximately $34 million and approximately $44 million, respectively, primarily driven by net interest expense.

•Third quarter 2025 GAAP and Non-GAAP effective tax rates were 16.3% and 17.2%, respectively. Third quarter 2024 GAAP and Non-GAAP effective tax rates were 13.9% and 13.8%, respectively.
Financial Position

•Third quarter 2025 net cash flow from operations was approximately $1.3 billion. Capital expenditures were approximately $46 million, and free cash flow, a Non-GAAP financial measure defined as net cash flow from operations less capital expenditures, was approximately $1.2 billion.

•As of September 30, 2025, Biogen had cash and cash equivalents totaling approximately $4.0 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $2.3 billion.

•For the third quarter of 2025 the Company’s weighted average diluted shares were approximately 147 million.
Full Year 2025 Financial Guidance

Biogen is updating its guidance for full year 2025 to reflect a stronger business outlook since July 2025 and the impact of business development transactions that are expected to close in the fourth quarter of 2025. Full year 2025 Non-GAAP diluted EPS range is expected as follows:
Full Year 2025 Non-GAAP Diluted EPS
Prior Guidance (July 2025) $15.50 to $16.00
Benefit from stronger business outlook +$0.25
Revised business outlook (October 2025) $15.75 to $16.25
Approx. impact from BD transactions expected to close in Q4’25 ~($1.25)
Updated Guidance $14.50 to $15.00

This updated Non-GAAP diluted EPS guidance range reflects a $0.25 EPS benefit from an expected stronger business outlook for the full year, partially offset by the expected ~($1.25) EPS impact from business development transactions expected to close in the fourth quarter of 2025.
For 2025 as compared to 2024, Biogen now expects total revenue to be approximately flat to increasing 1%, at constant currency. This reflects the strong revenue performance year-to-date, including the resilient performance of the U.S. MS business. Biogen expects increased competitive pressures on the ex-U.S. MS business in the fourth quarter of 2025, particularly for TECFIDERA in Europe. Due to planned campaign timing of contract manufacturing versus Biogen innovator product manufacturing, Biogen expects manufacturing revenue in the fourth quarter of 2025 of between $10 million and $20 million.

The Fit for Growth program is expected to generate approximately $1 billion of gross savings and $800 million net of reinvestment by the end of 2025. In 2025, Biogen plans to make additional investments in R&D to enable acceleration and expansion of the clinical development activities, primarily in support of rare disease, as well as additional investments in spend to support launch products. Biogen expects combined Non-GAAP R&D expense and Non-GAAP SG&A expense to total approximately $1.1 billion in the fourth quarter of 2025.
This financial guidance incorporates the Company’s view that Biogen’s 2025 financial outlook is not currently expected to be materially impacted by potential tariffs announced by the U.S. Administration during 2025, even if the exemption for pharmaceuticals were to be removed. This expectation is based on both a significant proportion of U.S. revenue being derived from products which have manufacturing operations in the U.S., and the Company’s current global inventory positions. The U.S. and international tariff landscape remains uncertain, and this guidance does not include contemplation of any new tariffs.
This financial guidance also assumes that foreign exchange rates as of October 24, 2025, will remain in effect for the remainder of the year, net of hedging activities.
Unless expressly stated above, this financial guidance does not include any impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are hard to predict. Some other financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2025 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.
Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Other Key Recent Events

•In October 2025, Biogen announced a license agreement granting Biogen exclusive worldwide rights to Vanqua Bio’s preclinical, oral C5aR1 antagonist designed to modulate neutrophil-driven inflammation, a central mechanism underlying many inflammatory diseases. Under the terms of the agreement, Vanqua Bio will receive a $70 million upfront payment.

•In September 2025, Biogen announced it entered into a definitive agreement to acquire Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ThecaFlex DRx, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of antisense oligonucleotides. Under the terms of the agreement, Biogen has agreed to acquire Alcyone Therapeutics for an upfront cash payment of $85 million plus certain milestones payable related to the development and regulatory approval of ThecaFlex DRx with nusinersen and additional pipeline products, securing all rights to ThecaFlex DRx. The transaction is subject to customary closing conditions.

Conference Call and Webcast

The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:30 a.m. ET on October 30, 2025 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, OCT 30, 2025, View Source [SID1234657141])

On October 30, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conferences next month:

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Stifel 2025 Healthcare Conference
November 12, 2025
10:40 a.m. ET – fireside chat

TD Cowen’s Immunology & Inflammation Summit
November 13, 2025
5 p.m. ET – fireside chat

A simultaneous webcast of the event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

(Press release, Nkarta, OCT 30, 2025, View Source [SID1234657160])

On October 30, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, reported that eBioMedicine, a Lancet Discovery Science journal, has published the Company’s phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers. The full text article, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," can be viewed via Online First 105980 October 29, 2025.

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Jacob Stephen Thomas, M.D. Assistant Professor of Clinical Medicine at Keck School of Medicine of the University of Southern California (USC) and medical oncologist with USC’s Norris Comprehensive Cancer Center, is the first author. Anthony El-Khoueiry, M.D., Associate Director for Clinical Research and Chief of Section of Developmental Therapeutics/Phase I Program at USC Norris, is the senior and corresponding author.

The manuscript includes the following data results:

In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved:
A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months
In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months

In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient’s total tumour burden ("TTB") compared to those treated with less than 40% of their TTB, the:
Disease control rate was 83.3% (40/48) compared to 50% (8/16)
Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001 (see Figure 1 below)
Improved survival was consistent across a range of low to high tumor burden and tumor sizes

Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects
Fifteen of 64 patients survived for more than 21 months
INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment
No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events
Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors
"INT230-6 is a local treatment that kills cancer using a diffusion process following direct injection into tumors. The trial demonstrated favorable safety and promising efficacy in patients with advanced metastatic cancers who had failed a median of three prior lines of therapy. The disease control rates and median survival compare favorably to those historically seen for such a diverse set of refractory cancer types in a phase 1/2 study," said Jacob S. Thomas, M.D. "There were also several learnings about INT230-6 dosing and safety gained during this trial. The pharmacokinetic data indicated that high rates of the drug are absorbed by the injected tumor, with minimal leakage, even at doses as high as 175 mL administered to a single tumor. These results are consistent with the low incidence of grade 3 adverse events observed."

"The mechanism by which cancer is killed through the diffusion of cytotoxic agents following intratumoral injection of INT230-6 and systemic immune activation, as observed in preclinical models, translated well in the human setting. Uninjected tumors shrinking from a locally administered therapy, referred to as abscopal effects, are generally rare for local therapies. Yet, an abscopal effect was observed in at least 20% of 48 patients who received drug volumes above 40% of their tumor burden. In addition, in thirteen of fourteen matched pair biopsy slides, a notable increase in activated CD4+ and CD8+ T cells was observed in the tumor microenvironment in response to INT230-6 treatment. Representative images can be found in the paper," said Anthony El-Khoueiry M.D. "The abscopal effects and immune cell infiltration observed in this study highlight this intratumoral therapy’s potential to drive both a local and systemic anti-cancer activity."

"This comprehensive paper is the culmination of over a decade of nonclinical and clinical research. The article describes the development of a new technology to destroy tumors using molecular agents that can disperse potent anti-cancer compounds within injected tumors and deliver them into cancer cells. We believe these are the first clinical results where a locally administered therapy used alone could potentially extend survival for patients with metastatic disease," said Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics, Inc. "As Drs. Thomas and El-Khoueiry noted, our paper reports that INT230-6 injected into visible tumors in metastatic patients at an amount based on the size of the injected tumors supports the hypothesis that INT230-6 causes immunologic cancer cell death, even in cancers that are considered immunologically cold. Given the drug’s mechanism of action and the data reported in this paper from over 20 types of metastatic solid cancers, such as breast, sarcoma, pancreatic, lung, and head and neck, we believe the study results show the potential of INT230-6 to achieve clinical benefit for metastatic patients of multiple cancer types with or without the use of radiation, systemic drugs or immunotherapy. As a result, we have initiated randomized controlled studies, including a Phase 3 study in sarcoma (NCT06263231)."

The Company will be hosting a conference call featuring two key authors of the study on Friday, October 31, 2025 at 9:00AM ET to discuss the results. Interested parties can access the call by clicking here: View Source Participants are encouraged to log on at least 10 minutes prior to the start of the event.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, OCT 30, 2025, View Source [SID1234657177])

About Study Intensity’s Clinical Study IT-01
IT-01 was Intensity’s first-in-human, open-label, single-arm phase 1/2 study (NCT03058289) using INT230-6. The study was conducted in patients with advanced, refractory, or metastatic solid tumors at six clinical sites in addition to USC. Other investigators were from Johns Hopkins University, Princess Margaret Hospital in Toronto, Columbia Presbyterian in New York, The Fox Chase Cancer Center in Philadelphia, Houston Methodist, and UMass Memorial. The study was comprised of adults with histologically or cytologically confirmed advanced or metastatic solid tumors who did not respond to or were not candidates for standard therapies and had accessible superficial and/or deep tumors for injection. Dose escalation was achieved by increasing the initial and subsequent total dose volumes (total injected amount), the maximum injected volume per any single tumor, the ratio of drug-volume to tumor-size, the number of injected tumors per session, and the dose frequency (once per month vs. every 2 weeks). Maintenance dosing was added in protocol amendments. A tumor’s dose was set as a percentage of the volume of the target tumor, which was calculated from radiologic measurements. There were six monotherapy dose cohorts.

On October 30, 2025 Bristol Myers Squibb (NYSE: BMY) reported results for the third quarter of 2025.

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"We delivered strong results this quarter as a result of continued execution across the business and ongoing Growth Portfolio momentum," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "We’re focused on building for the future by accelerating innovation, advancing our pipeline, staying agile and delivering more transformational medicines to more patients."

Third Quarter Results
$ in millions, except per share amounts 2025 2024 Change
Change Excl. FX**
Total Revenues $12,222 $11,892 3 % 2 %
Earnings/(Loss) Per Share – GAAP* 1.08 0.60 81 % N/A
Earnings/(Loss) Per Share – Non-GAAP* 1.63 1.80 (9) % N/A
Acquired IPRD Charges and Licensing Income Net Impact on Earnings/(Loss) Per Share (0.20) (0.09) N/A N/A

*GAAP and Non-GAAP earnings/(loss) per share include the net impact of Acquired IPRD charges and licensing income.
**See "Use of Non-GAAP Financial Information".

1

THIRD QUARTER RESULTS
All comparisons are made versus the same period in 2024 unless otherwise stated.
•Growth Portfolio revenues of $6.9 billion increased 18%, or 17% Ex-FX. Revenue growth was primarily driven by our immuno-oncology (IO) portfolio, Reblozyl, Camzyos and Breyanzi.
•Legacy Portfolio revenues of $5.4 billion decreased 12%, or 13% Ex-FX. Demand increased for Eliquis, which was more than offset by expected continued generic impact across the remainder of the Legacy Portfolio.
•Total revenues of $12.2 billion increased 3%, or 2% Ex-FX.
◦U.S. revenues of $8.3 billion increased 1%.
◦International revenues of $3.9 billion increased 6%, or 3% Ex-FX.
THIRD QUARTER PRODUCT REVENUE HIGHLIGHTS(d)

($ amounts in millions) Quarter Ended September 30, 2025
% Change from Quarter Ended September 30, 2024
% Change from Quarter Ended September 30, 2024 Ex-FX**

U.S.
Int’l
WW(c)
U.S.
Int’l
WW(c)
Int’l
WW(c)
Growth Portfolio
Opdivo $ 1,454 $ 1,077 $ 2,532 6 % 8 % 7 % 6 % 6 %
Opdivo Qvantig 60 7 67 N/A N/A N/A N/A N/A
Orencia 721 243 964 2 % 6 % 3 % 3 % 2 %
Yervoy 455 284 739 14 % 17 % 15 % 13 % 14 %
Reblozyl 494 121 615 38 % 35 % 37 % 31 % 37 %
Opdualag 259 40 299 20 % 122 % 28 % 115 % 27 %
Breyanzi 251 109 359 45 % 115 % 60 % 104 % 58 %
Camzyos 238 57 296 76 % 177 % 89 % 168 % 88 %
Zeposia 113 48 161 8 % 13 % 9 % 6 % 7 %
Abecma 51 86 137 (34) % 80 % 9 % 71 % 6 %
Sotyktu 51 29 80 — % 91 % 21 % 87 % 20 %
Krazati 48 5 53 52 % 144 % 58 % 133 % 57 %
Cobenfy 43 — 43 N/A N/A N/A N/A N/A
Other Growth Products(a)
195 319 514 8 % 22 % 16 % 21 % 16 %
Total Growth Portfolio
4,432 2,425 6,857 17 % 20 % 18 % 17 % 17 %
Legacy Portfolio
Eliquis 2,631 1,115 3,746 29 % 16 % 25 % 11 % 23 %
Revlimid 485 89 575 (60) % (55) % (59) % (56) % (59) %
Pomalyst/Imnovid 596 79 675 (15) % (61) % (25) % (61) % (25) %
Sprycel 69 49 119 (69) % (24) % (59) % (25) % (59) %
Abraxane 24 50 74 (84) % (50) % (71) % (49) % (70) %
Other Legacy Products(b)
92 85 177 (11) % (29) % (21) % (30) % (21) %
Total Legacy Portfolio 3,897 1,468 5,365 (12) % (11) % (12) % (14) % (13) %
Total Revenues $ 8,329 $ 3,893 $ 12,222 1 % 6 % 3 % 3 % 2 %

** See "Use of Non-GAAP Financial Information".
(a) Includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.
(b) Includes other mature brands.
(c) Worldwide (WW) includes U.S. and International (Int’l).
(d) For the above table and all subsequent tables, certain totals may not sum due to rounding. Percentages have been calculated using unrounded amounts.

2

THIRD QUARTER COST & EXPENSES
All comparisons are made versus the same period in 2024 unless otherwise stated.
The table below presents selected line-item information.

Three Months Ended September 30, 2025 Three Months Ended September 30, 2024
($ amounts in millions)
GAAP
Specified Items**
Non-GAAP
GAAP
Specified Items**
Non-GAAP
Cost of products sold
$ 3,435 (122) $ 3,312 $ 2,957 (101) $ 2,856
Gross margin(a)
71.9 % 72.9 % 75.1 % 76.0 %
Selling, general and administrative
1,789 (1) 1,788 1,983 (7) 1,976
Research and development
2,528 (95) 2,433 2,374 (21) 2,353
Acquired IPRD
633 — 633 262 — 262
Amortization of acquired intangible assets
831 (831) — 2,406 (2,406) —
Other (income)/expense, net
(108) (98) (206) 234 (275) (41)
Effective tax rate
29.5 % (7.2) % 22.3 % 27.5 % (9.0) % 18.5 %

**See "Use of Non-GAAP Financial Information" and refer to the Specified Items schedule below for further detail.
(a) Represents revenue minus cost of products sold divided by revenue.

•Gross margin on a GAAP and non-GAAP basis was 71.9% and 72.9% in 2025, and 75.1% and 76.0% in 2024, respectively, reflecting the change in product mix.
•Selling, general and administrative expenses of $1.8 billion decreased 10% on a GAAP and non-GAAP basis, primarily driven by our ongoing strategic productivity initiative.
•Research and development expenses of $2.5 billion increased 6% on a GAAP basis, primarily due to an IPRD impairment charge. Non-GAAP research and development expenses of $2.4 billion increased 3%, primarily due to the impact of recent acquisitions, partially offset by our ongoing strategic productivity initiative.
•Acquired IPRD charges of $633 million increased from $262 million on a GAAP and non-GAAP basis, primarily driven by the Philochem licensing arrangement and achievement of a milestone under the SystImmune collaboration. Licensing income increased from $25 million to $107 million on a GAAP and non-GAAP basis, primarily reflecting the execution of an out-licensing arrangement in 2025.
•Amortization of acquired intangible assets of $831 million decreased 65% on a GAAP basis, primarily due to lower amortization expense related to Revlimid.
•Effective tax rate increased from 27.5% to 29.5% on a GAAP basis, and from 18.5% to 22.3% on a non-GAAP basis. The increase in the non-GAAP effective tax rate was driven by jurisdictional earnings mix.
•Net income attributable to Bristol Myers Squibb of $2.2 billion, or $1.08 per share, increased from $1.2 billion, or $0.60 per share, on a GAAP basis. On a non-GAAP basis, net income attributable to Bristol Myers Squibb of $3.3 billion, or $1.63 per share, decreased from $3.7 billion, or $1.80 per share. GAAP and non-GAAP EPS include the impacts of Acquired IPRD charges and licensing income.

PRODUCT AND PIPELINE UPDATES
Entries organized by date and inclusive of third quarter and recent updates.
Asset(s)
Date Announced
Milestone
Sotyktu (deucravacitinib)
October 27
52-week data from the pivotal Phase 3 POETYK PsA-1 trial demonstrated that Sotyktu improved and maintained meaningful clinical responses, inhibition of radiographic progression and patient-reported outcomes in adults with active psoriatic arthritis.

In addition, data from an integrated analysis of the Phase 2 PAISLEY-SLE and PAISLEY long-term extension studies supported the safety and efficacy with up to four years of Sotyktu treatment for moderate-to-severe systemic lupus erythematosus (SLE).
CD19 NEX-T (BMS-986353)
October 25
Announced positive, updated data and early results from the Phase 1 Breakfree-1 study evaluating BMS-986353, an investigational, autologous CD19-targeted NEX-T CAR T cell therapy, across the systemic sclerosis, SLE and idiopathic inflammatory myopathies cohorts. The preliminary Phase 1 safety and efficacy results are consistent with the potential for immune reset, showing robust CAR T cell expansion, complete B cell depletion and re-emergence of a naive B cell phenotype across all three cohorts.
izalontamab brengitecan
(iza-bren)
October 17
First disclosure of safety and efficacy data presented with SystImmune from the global Phase I US-Lung-101 study of iza-bren, a potentially first-in-class EGFR x HER3 bispecific antibody-drug conjugate, demonstrated promising antitumor activity in heavily pre-treated patients across multiple tumor types, as well as a manageable safety profile.
BMS-986446 October 1
The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BMS-986446, a potential best-in-class, anti-microtubule binding region-tau antibody currently in Phase 2 development for the treatment of early Alzheimer’s disease.
Sotyktu September 25
Announced an expansion of the company’s direct-to-patient offerings, providing eligible U.S. patients with steeply discounted prices for Sotyktu via the new BMS Patient Connect platform, beginning January 2026.
iberdomide September 23
The Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint.
pumitamig (BNT327 / BMS-986545)
September 8
First disclosure of data presented with BioNTech SE from the global randomized Phase 2 trial (NCT06449209) evaluating pumitamig, an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer demonstrated encouraging anti-tumor responses with a positive trend in the secondary endpoint of progression free survival.

Additionally, this week pivotal studies for pumitamig and chemotherapy combinations are now initiating in first-line (1L) microsatellite stable colorectal cancer and 1L gastric cancer.
Camzyos (mavacamten)
August 29
Results from the global, retrospective COLLIGO-HCM study showed that Camzyos was associated with reductions in left ventricular outflow tract obstruction and improvements in symptom burden in a racially diverse population of patients with symptomatic obstructive hypertrophic cardiomyopathy treated in an international, real-world setting.

iza-bren
August 18
The FDA granted Breakthrough Therapy Designation to iza-bren for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy.
Breyanzi (lisocabtagene maraleucel)
August 4
The FDA accepted the supplemental biologics license application for Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act goal date of December 5, 2025.

Business Development
In October 2025, the company announced a definitive agreement to acquire Orbital Therapeutics. The acquisition includes OTX-201, Orbital’s lead RNA immunotherapy preclinical candidate currently in IND-enabling studies. This investigational, next-generation CAR T-cell therapy is designed to reprogram cells in vivo and has the potential to offer a best-in-class profile for treating autoimmune diseases, aligned with Bristol Myers Squibb’s overall immune reset strategy. This in vivo approach, in which the patient’s own body serves as the manufacturer of CAR T-cells, has the potential to offer a reduced treatment burden, added convenience and improved accessibility compared to ex vivo CAR T-cell therapies. Bristol Myers Squibb will also gain access to Orbital’s differentiated RNA technology platform that integrates advanced RNA engineering and delivery methods, offering the potential to expand therapeutic applications and address additional diseases. The transaction is subject to the satisfaction of customary closing conditions.

Financial Guidance
Bristol Myers Squibb is increasing its full-year 2025 non-GAAP revenue guidance from a range of approximately $46.5 billion to $47.5 billion, to a range of approximately $47.5 billion to $48.0 billion. This update primarily reflects the continued strong performance of our Growth Portfolio.
Full-year other income and expense in 2025 is now expected to be approximately $500 million of income due to higher-than-anticipated royalties and licensing income, as well as favorable interest income.
Non-GAAP EPS is now expected to be in the range of $6.40 – $6.60, inclusive of an $(0.80) per share net impact related to Acquired IPRD charges and licensing income.
Non-GAAP2,3

July
(Prior) October
(Updated)
Total Revenues
(Reported & Ex-FX)
~$46.5 – $47.5 billion ~$47.5 – $48.0 billion
Gross Margin % ~72% No change
Operating Expenses1
~$16.5 billion No change
Other income/(expense) ~$250 million ~$500 million
Effective tax rate ~18% No change
Diluted EPS $6.35 – $6.65 $6.40 – $6.60
Acquired IPRD Charges and Licensing Income Included in Diluted EPS $(0.60) $(0.80)

1 Operating Expenses = SG&A and R&D.
2 See "Use of Non-GAAP Financial Information."
3 July was calculated using foreign exchange rates as of July 25, 2025, and October was calculated using foreign
exchange rates as of October 28, 2025.

The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, including Orbital Therapeutics, which is expected to close in the fourth quarter of 2025, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges and licensing income. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website, www.bms.com, in the "Investors" section. Non-GAAP guidance assumes exchange rates as of the date noted. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

(Press release, Bristol-Myers Squibb, OCT 30, 2025, View Source [SID1234657142])

On October 30, 2025 Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, reported it will give an oral late-breaker as well as a poster presentation of additional results from a Phase 1b/2 trial evaluating NOUS-209 in Lynch Syndrome (LS) carriers at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting being held in National Harbor, MD, USA on November 5-9, 2025. The company will also present further data validating NOUS-209 mechanism of action (MoA) in LS carriers at the SITC (Free SITC Whitepaper) meeting.

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Oral Presentation Details:

Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers: Annual Revaccination Boosts T Cell Immunity Informing Future Cancer Interception Strategies

Session: Clinical Oral Abstract Session 2
Date & Time: Saturday, November 8, 2025, 1:45 PM – 3:00 PM ET
Location: Gaylord National Resort & Convention Center, Potomac Ballroom

Poster Presentations Details:

Poster #118 – NOUS-209 Mechanism of Action Validation
Title: NOUS-209 Enables Broad Targeting of Primary and Metachronous Tumors in Lynch Syndrome

Session: Poster Hall
Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
Location: Prince George’s ABC

Poster #1336 – NOUS-209 Clinical Data
Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers

Session: Poster Hall
Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
Location: Prince George’s ABC

All abstracts are available on the SITC (Free SITC Whitepaper) website View Source

LS is a common inherited condition caused by DNA repair gene mutations. It affects approximately 1 in 300 people, leading to a significantly increased lifetime cancer risk of up to 80%. While current LS disease management relies on frequent screenings or preventive surgery, cancer interception with NOUS-209 aims to train the immune system to recognize and eliminate cancerous cells before they fully develop, grow and spread.

NOUS-209 is an off-the-shelf immunotherapy designed to target tumors with specific genetic deficiencies known as mismatch repair deficiency (dMMR) and/or microsatellite instability (MSI). These tumors produce unique markers known as frameshift peptide (FSP) neoantigens, which serve as tumor-specific neoantigens. Because these FSPs are exclusively found in cancerous cells, they are readily recognizable by the immune system and therefore are ideal targets for immunotherapy. NOUS-209 encodes 209 unique FSP neoantigens shared across multiple MSI tumor types, enabling its potential to treat a broad range of MSI-associated cancers.

Following positive Type B and C meetings with the US Food and Drug Administration (FDA), Nouscom has a clear path forward for the advancement of NOUS-209 into a registration-enabling Phase 2/3 clinical study for cancer interception in LS carriers.

The clinical trial NCT05078866 was led by researchers at The University of Texas MD Anderson Cancer Center, in collaboration with the Cancer Prevention Clinical Trials Network (CP-CTNet) and sponsored by the National Cancer Institute (grant # UG1CA242609). The activities are coordinated by the iCAN-PREVENT consortium of MD Anderson Cancer Center.

(Press release, NousCom, OCT 30, 2025, View Source;utm_medium=rss&utm_campaign=nouscom-to-present-new-positive-phase-1b-2-clinical-and-translational-data-on-nous-209-immunogenicity-and-cancer-interception-potential-in-lynch-syndrome-carriers-at-sitc-2025 [SID1234657161])