On October 30, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported to have strengthened its financial position through different capital markets activities. As a result, Evaxion now has cash on hand to fund its operations and R&D programs into the second half of 2027, extended from first half of 2027.

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In total, Evaxion has raised $7.2 million in recent weeks, with $4.5 million coming from sale of shares in an at-the-market (ATM) offering and $2.7 million coming from exercise of investor warrants.

The proceeds strengthens both Evaxion’s cash position and equity and follows the influx of $7.5 million paid by MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) when licensing vaccine candidate EVX-B3 in September 2025.

"We are pleased to have bolstered our cash position thereby extending our runway into the second half of 2027, allowing us to fully focus on executing on our strategy and plans," says Thomas Schmidt, CFO of Evaxion.

The recent exercises of investor warrants have reduced the number of outstanding warrants to purchase Evaxion ADSs by 1.0 million. The total number of outstanding warrants is now 2.8 million, including employee warrants, with a weighted average exercise price of $10.94.

Evaxion expects to accumulate an operational cash spend of $14 million in 2025. By the end of the second quarter 2025, Evaxion had cash at hand of $14.7 million. We have since had a gross inflow of cash of $14.7 million as mentioned above.

Evaxion had debt of $9.2 million by the end of the second quarter 2025. The debt was reduced by $4.1 million through a debt-to-equity conversion agreement with the European Investment Bank in July 2025, also bolstering Evaxion’s equity.

(Press release, Evaxion Biotech, OCT 30, 2025, View Source [SID1234657148])

On October 30, 2025 Eli Lilly and Company (NYSE: LLY) reported its financial results for the third-quarter of 2025.

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"Lilly delivered another strong quarter, with 54% revenue growth year-over-year driven by continued demand for our incretin portfolio," said David A. Ricks, Lilly chair and CEO. "We advanced orforglipron through four additional Phase 3 trials, enabling global obesity submissions by year-end, and we achieved U.S. FDA approval of Inluriyo (imlunestrant)—marking key progress across our pipeline. We continue to increase manufacturing capacity, announcing new facilities in Virginia and Texas and an expansion of our site in Puerto Rico."

Financial Results

$ in millions, except

per share data

Third-Quarter

2025

2024

% Change

Revenue

$ 17,600.8

$ 11,439.1

54 %

Net income – Reported

5,582.5

970.3

NM

Earnings per share – Reported

6.21

1.07

NM

Net income – Non-GAAP

6,311.9

1,064.5

NM

Earnings per share – Non-GAAP

7.02

1.18

NM

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Third-Quarter Reported Results
In Q3 2025, worldwide revenue was $17.60 billion, an increase of 54% compared with Q3 2024, driven by a 62% increase in volume, partially offset by a 10% decrease due to lower realized prices. Key Products1 revenue grew to $11.98 billion in Q3 2025, led by Mounjaro and Zepbound.

Revenue in the U.S. increased 45% to $11.30 billion, driven by a 60% increase in volume, partially offset by a 15% decrease due to lower realized prices. Price was negatively impacted by a favorable one-time adjustment to estimates for rebates and discounts in Q3 2024. Excluding this base period effect, U.S. price declined by high single digits.

Revenue outside the U.S. increased 74% to $6.30 billion, driven by a 66% increase in volume and to a lesser extent a 6% favorable impact on foreign exchange rates. The volume increase outside the U.S. was driven primarily by Mounjaro. Revenue included a $200.0 million sales-based milestone payment for Jardiance and $180.0 million of revenue associated with the divestiture of the rights to Cialis in select markets outside of the U.S.

The Company defines Key Products as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio, and Zepbound.

Gross margin increased 57% to $14.59 billion in Q3 2025. Gross margin as a percent of revenue was 82.9%, an increase of 1.9 percentage points. The increase in gross margin percent was primarily driven by favorable product mix, partially offset by lower realized prices.

In Q3 2025, research and development expenses increased 27% to $3.47 billion, or 19.7% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 31% to $2.74 billion in Q3 2025, primarily driven by promotional efforts supporting ongoing and future launches.

In Q3 2025, the company recognized acquired in-process research and development (IPR&D) charges of $655.7 million compared with $2.83 billion in Q3 2024. The Q3 2025 charges primarily related to the acquisition of SiteOne Therapeutics, Inc. The Q3 2024 charges were primarily related to the acquisition of Morphic Holding, Inc.

Asset impairment, restructuring and other special charges of $364.9 million in Q3 2025 were primarily related to a litigation charge, as well as acquisition and integration costs associated with the closing of our acquisition of Verve Therapeutics, Inc. In Q3 2024, there was a charge of $81.6 million, that primarily related to impairment of an intangible asset associated with a molecule in development.

The effective tax rate was 22.8% in Q3 2025 compared with 38.9% in Q3 2024. The effective tax rates for Q3 2025 and Q3 2024 were both unfavorably impacted by non-deductible acquired IPR&D charges, with a larger impact occurring in Q3 2024. Additionally, the effective tax rate for Q3 2025 was unfavorably impacted by U.S. tax law changes enacted during the quarter.

In Q3 2025, net income and earnings per share (EPS) were $5.58 billion and $6.21, respectively, compared with net income of $970.3 million and EPS of $1.07 in Q3 2024. EPS in Q3 2025 and Q3 2024 included acquired IPR&D charges of $0.71 and $3.08, respectively.

Third-Quarter Non-GAAP Measures
On a non-GAAP basis, Q3 2025 gross margin increased 56% to $14.71 billion. Gross margin as a percent of revenue was 83.6%, an increase of 1.4 percentage points. The increase in gross margin percent was primarily driven by favorable product mix, partially offset by lower realized prices.

The non-GAAP effective tax rate was 17.7% in Q3 2025 compared with 37.6% in Q3 2024. The effective tax rates for Q3 2025 and Q3 2024 were both unfavorably impacted by non-deductible acquired IPR&D charges, with a larger impact occurring in Q3 2024.

On a non-GAAP basis, Q3 2025 net income and EPS were $6.31 billion and $7.02, respectively, compared with net income of $1.06 billion and EPS of $1.18 in Q3 2024. Non-GAAP EPS in Q3 2025 and Q3 2024 included acquired IPR&D charges of $0.71 and $3.08, respectively.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Third-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 6.21

$ 1.07

NM

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other
special charges

.36

.07

Net losses (gains) on investments in equity
securities

(.04)

(.09)

U.S. Tax Law Change

.39

—

Earnings per share (non-GAAP)

$ 7.02

$ 1.18

NM

Acquired IPR&D

.71

3.08

(77) %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Third-Quarter

Year-to-Date

Selected Products

2025

2024

%
Change

2025

2024

%
Change

Mounjaro

$ 6,515.1

$ 3,112.7

109 %

$ 15,555.8

$ 8,010.0

94 %

Zepbound

3,588.1

1,257.8

185 %

9,281.3

3,018.4

NM

Verzenio

1,470.2

1,369.3

7 %

4,118.3

3,751.5

10 %

Total Revenue

17,600.8

11,439.1

54 %

45,887.0

31,509.9

46 %

NM – not meaningful

Mounjaro
For Q3 2025, worldwide Mounjaro revenue increased 109% to $6.52 billion. U.S. revenue was $3.55 billion, an increase of 49%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $2.97 billion compared with $728.0 million in Q3 2024, primarily driven by volume growth.

Zepbound
For Q3 2025, U.S. Zepbound revenue increased 184% to $3.57 billion, compared with $1.26 billion in Q3 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q3 2025, worldwide Verzenio revenue increased 7% to $1.47 billion. U.S. revenue was $880.3 million, compared with $878.8 million in Q3 2024, reflecting an increase in volume which was offset by lower realized prices. Revenue outside the U.S. was $589.8 million, an increase of 20%, primarily driven by volume growth and, to a lesser extent, favorable impact on foreign exchange rates.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Lilly’s Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis (announcement)

Lilly’s Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer’s disease (announcement)

U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer (announcement)

Lilly’s olomorasib receives U.S. FDA’s Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers (announcement)

Clinical

Lilly’s Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis (announcement)

Lilly’s EBGLYSS (lebrikizumab-lbkz) delivered durable disease control when administered once every eight weeks in patients with moderate-to-severe atopic dermatitis (announcement)

Lilly’s baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial (announcement)

Lilly’s Verzenio (abemaciclib) prolonged survival in HR+, HER2-, high-risk early breast cancer with two years of treatment (announcement)

Lilly’s oral GLP-1, orforglipron, demonstrated superior glycemic control in two successful Phase 3 trials, reconfirming its potential as a foundational treatment in type 2 diabetes (announcement)

Lilly’s Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 antagonist to show four years of sustained, corticosteroid-free comprehensive patient outcomes in ulcerative colitis (announcement)

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, reduced A1C by an average of 2.2% in a Phase 3 trial of children and adolescents with type 2 diabetes (announcement)

Lilly’s oral GLP-1, orforglipron, superior to oral semaglutide in head-to-head trial (announcement)

Lilly’s oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results published in The New England Journal of Medicine (announcement)

Lilly’s Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, significantly improved progression-free survival in patients with treatment-naïve CLL/SLL (announcement)

Lilly’s Verzenio (abemaciclib) increases overall survival in HR+, HER2-, high-risk early breast cancer with two years of therapy (announcement)

Lilly’s oral GLP-1, orforglipron, is successful in third Phase 3 trial, triggering global regulatory submissions this year for the treatment of obesity (announcement)

Other

Lilly announces more than $1.2 billion investment in Puerto Rico facility to boost oral medicine manufacturing capacity in the United States (announcement)

LillyDirect and Walmart Pharmacy launch first retail pick-up option with direct-to-consumer pricing for Zepbound (announcement)

Lilly partners with NVIDIA to build the industry’s most powerful AI supercomputer, supercharging medicine discovery and delivery for patients (announcement)

Lilly announces roster of Team USA athletes for the Olympic and Paralympic Games Milano Cortina 2026, pledges to translate U.S. Olympic and Paralympic milestones into meaningful community impact (announcement)

Lilly to Acquire Adverum Biotechnologies (announcement)

Lilly opens newest Gateway Labs site in San Diego to boost local biotechnology ecosystem (announcement)

Lilly plans to build a new $6.5 billion facility to manufacture active pharmaceutical ingredients in Texas (announcement)

Lilly announces plans to build $5 billion manufacturing facility in Virginia (announcement)

Lilly launches TuneLab platform to give biotechnology companies access to AI-enabled drug discovery models built through over $1 billion in research investment (announcement)

Anne White to Retire as Executive Vice President and President, Lilly Neuroscience (announcement)

For information on important public announcements, visit the news section of Lilly’s website.

2025 Financial Guidance
The company has increased full-year revenue guidance to be in the range of $63.0 billion to $63.5 billion, primarily driven by strong underlying business performance across the portfolio and foreign exchange rates.

The performance margin2 is now expected to be in the range of 43.5% and 44.5% on a reported basis and 45.0% and 46.0% on a non-GAAP basis. Both ratios reflect the increase in revenue guidance.

Other income (expense) on a reported basis is now expected to be expense in the range of $700 million to $600 million due to a decrease in net losses on investments in equity securities and is still expected to be expense in the range of $700 million to $600 million on a non-GAAP basis.

The 2025 estimated effective tax rate on a reported basis and a non-GAAP basis remain unchanged at approximately 19% and 17%, respectively.

Based on these changes, EPS guidance has been increased to be in the range of $21.80 to $22.50 on a reported basis and $23.00 to $23.70 on a non-GAAP basis. The company’s updated 2025 financial guidance reflects adjustments shown in the reconciliation table below.

2025

Guidance

Earnings per share (reported)

$21.80 to $22.50

U.S. tax legislation

.39

Amortization of intangible assets

.43

Asset impairment, restructuring, and other special charges

.39

Net losses on investments in equity securities

—

Earnings per share (non-GAAP)

$23.00 to $23.70

Numbers may not add due to rounding

The Company defines performance margin as gross margin less R&D, Marketing, Selling, and Administrative and Asset Impairment, Restructuring and Other Charges divided by Revenue.

The following table summarizes the company’s updated 2025 financial guidance:

Prior

Revenue

$60.0 to $62.0 billion

$63.0 to $63.5 billion

Performance Margin(4)

(reported)

42.0% to 43.5%

43.5% to 44.5%

(non-GAAP)

43.0% to 44.5%

45.0% to 46.0%

Other Income/(Expense) (reported)

($750) to ($650) million

($700) to ($600) million

Other Income/(Expense) (non-GAAP)

($700) to ($600) million

Unchanged

Tax Rate (reported)

Approx. 19%

Unchanged

Tax Rate (non-GAAP)

Approx. 17%

Unchanged

Earnings per Share (reported)

$20.85 to $22.10

$21.80 to $22.50

Earnings per Share (non-GAAP)

$21.75 to $23.00

$23.00 to $23.70

(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.

(2) Guidance includes acquired IPR&D charges through Q3 2025 of $2.38 billion or $2.57 on a per share basis. Guidance does not include acquired IPR&D either incurred, or expected to be incurred, after Q3 2025.

(3) This guidance is based on the existing tariff and trade environment as of October 30, 2025, and does not reflect any policy shifts, including pharmaceutical sector tariffs, that could impact business.

(4) The Company defines performance margin as gross margin less R&D, Marketing, Selling, and Administrative, and Asset Impairment, Restructuring and Other Charges divided by Revenue.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q3 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

(Press release, Eli Lilly, OCT 30, 2025, View Source [SID1234657147])

On October 30, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the third quarter ended September 30, 2025, and provides an overview of recent and upcoming business highlights.

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"Our team continues to execute solidly across the three most important business verticals: diagnostics, therapeutics, and capital structure," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "In the fourth quarter, we plan to build on growing momentum in these three areas as we expand our commercial team and footprint for CNSide, seek to clarify our clinical development and pivotal plan for REYOBIQ with the FDA, and bolster our financial position in the capital markets."

Q3 2025 AND RECENT HIGHLIGHTS

Corporate

•
Received additional $1.9 million advance payment from Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally, as part of the Company’s previously awarded non-dilutive $17.6 million grant for leptomeningeal cancer targeted radiotherapeutic development
•
Regained compliance with applicable Nasdaq listing criteria, including both Market Value of Listing Securities standard and alternative stockholder’s equity threshold

REYOBIQ Clinical Trials

•
Presented positive ReSPECT-LM Phase 1 single dose escalation trial results at SNO/ASCO CNS Metastases Conference. The data demonstrated treatment of leptomeningeal metastases (LM) with REYOBIQ is feasible, has favorable safety profile, and shows promising efficacy signal

CNSide CSF Assay Platform

•
Expanded commercial readiness and purpose driven footprint for CNSide to support commercial scale up and patient-led innovative research. Appointed new leadership in commercial strategy and technical operations, in addition to new hires, to meet commercial and operational targets
•
Announced first of planned national coverage agreements, with UnitedHealthcare effective September 15, 2025 covering over 51 million people throughout the U.S., to provide the CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test (LDT)
•
Received successful accreditation and certification from Centers for Medicare and Medicaid Services (CMS) under the Clinical Lab Improvement Amendments (CLIA) for the Houston Texas laboratory, which has met all requirements for proficiency testing, personnel qualifications, and quality control. The certification also paves the way for state licensing, commercial payor coverage, access to Medicare/Medicaid, and payment coding expansion
•
Presented positive CNSide CSF assay platform results at the 2025 SNO/ASCO CNS Metastases Conference. Data from a retrospective, multi-center analysis of 613 CNSide assays showed that CNSide can quantify LM over time and monitor changes in the expression of multiple targetable mutations. CNSide may also catalyze LM treatment initiation, allowing physicians to adapt treatment with real time shifts in tumor biology
•
Provided a CNSide Diagnostics launch update, with our CSF assay platform and testing services commercially available in Texas in August 2025. Initial commercial focus will be on National Cancer Institute Designated Cancer Centers, which treat the highest number of patients at risk for leptomeningeal metastases and previously used CNSide

Q3 2025 FINANCIAL RESULTS

•
The Company’s cash and investments balance was $16.6 million on September 30, 2025, up from $6.9 million on June 30, 2025 and $3.6 million on December 31, 2024
•
Recognized $1.4 million in grant revenue in the third quarter of 2025 compared to $1.5 million in the same quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM
•
Total operating loss for the third quarter of 2025 was $4.5 million compared to a loss of $3.8 million in the same quarter of 2024 with the increase primarily attributed to compensation expense and professional fees
•
Net loss for the third quarter of 2025 was $4.4 million, or loss of $0.04 per share, compared to a net loss of $2.9 million, or loss of $0.37 per share, for the same quarter in the prior year; the change in the net loss for the quarter was primarily due to $1 million of change in fair value of derivative instruments in Q3 2024

(Press release, Plus Therapeutics, OCT 30, 2025, View Source [SID1234657146])

On October 30, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported the presentation of new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

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CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).

"The RedTail platform represents a major advance in virotherapy and genetic medicines," said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "RedTail allows for systemically administered genetic medicines that avoid immune clearance, are tropic for tumor cells, induce tumor lysis and immunologically prime the TME, and can deliver a genetic payload."

"In our syngeneic models, CLD-401 can reach metastatic sites when administered systemically where it can destroy tumor cells through a novel mechanism that also induces an immune priming effect," added Eric Poma, PhD, Chief Executive Officer. "CLD-401 builds on these mechanisms by also delivering high levels of IL-15 superagonist to the TME to activate a potent T-cell and NK cell response to the tumor."

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026. The company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

CLD-401 Presentation

Meeting: SITC (Free SITC Whitepaper) 40th Anniversary Annual Meeting, November 7–9, 2025, National Harbor, MD
Title: In Situ Tumor Delivery of IL-15 Superagonist via RedTail Gene Therapy Achieves Durable Tumor Clearance
Abstract Number: 1175
Presentation Time: Friday, November 7, 2025, 12:15–1:45 PM and 5:35–7:00 PM

(Press release, Calidi Biotherapeutics, OCT 30, 2025, View Source [SID1234657145])

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])