On July 31, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2025 (Press release, Amplia Therapeutics, JUL 31, 2025, View Source [SID1234654649]).

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Key Highlights

• The ACCENT trial achieved a key activity threshold with 17 confirmed partial responses (PRs), showing a 31% response rate for narmafotinib combined with chemotherapy, which is superior to chemotherapy alone (23%).
• Two patients achieved complete responses, including one patient with undetectable cancer lesions for over two months and another with a rare pathological complete response in metastatic pancreatic cancer, garnering significant media attention.
• Progress has been made in initiating a second trial of narmafotinib, combining it with FOLFIRINOX chemotherapy in the USA and Australia, with ethics approvals now secured for both regions.
• Dr Jason Lickliter was appointed Chief Medical Officer in May, bringing extensive experience as a medical oncologist and clinical triallist, having advised Amplia since 2021.
• ACCENT trial data was presented for the initial 26-patient cohort at the prestigious American Association of Cancer Research annual meeting in April. • $27.5m capital raise announced in July 2025, funding the company into 2027

Operations Update

Significant developments in the ACCENT trial were achieved over this quarter. In May we reported that we had achieved the key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of our best-in-class FAK inhibitor narmafotinib with chemotherapy was superior to chemotherapy alone. At the time of writing we now have reported 17 confirmed PR’s, which equates to a response rate of 31%, superior to the 23% response rate observed for chemotherapy alone.

In June we announced that two (2) patients from the trial had achieved complete responses. In one patient, the cancer lesions had decreased in size over the course of treatment to become no longer detectable for over a 2-month period. In the second patient, surgical removal of tissue that appeared to be residual tumour was shown by pathology to be non-malignant tissue, meaning that the patient had achieved a pathological complete response. This latter finding is extremely rare in metastatic pancreatic cancer and resulted in significant media attention for the patient and the hospital where the treatment was delivered.

Further progress has been made towards initiation of the second trial of narmafotinib in pancreatic cancer, this time combining the drug with a different chemotherapy called FOLFIRINOX. This trial, to will be conducted in the USA and Australia, is designed to demonstrate that narmafotinib can also improve the response to FOLFIRINOX. In June we announced that ethics approval had been received from the central US Institutional Review Board (IRB), a critical approval required before sites can initiate patient recruitment. We have now also received similar ethics approval for the Australian sites. The first stage of the trial, where different doses of narmafotinib will be trialled in combination with FOLFIRINOX, is due to start imminently.

In May, the Company announced the appointment of Dr Jason Lickliter as Chief Medical Officer. Dr Lickliter is a highly experienced medical oncologist and clinical triallist and joins the Company in a part- time capacity, whilst retaining a CMO role at clinical trials organisation Nucleus Network. Dr Lickliter has been acting in the role of clinical adviser to Amplia since 2021 and has a deep knowledge of our clinical program and data.

In April, the Company presented ACCENT trial data for the initial cohort of 26 patients at the American Association of Cancer Research annual meeting, a highly prestigious cancer meeting that attracts scientists, clinicians and representatives from pharma and biotech from across the globe.

Outlook and future activities

The Company will continue to collect, analyse and report data from the ongoing ACCENT trial over the coming months. Initiation and progression of the FOLFIRINOX and narmafotinib combination trial, being conducted in the USA and Australia, will also be a major focus of the Amplia team. Interactions with regulatory agencies, in particular the US FDA, is also planned in the coming months.

Capital Raise

On 23 July the Company announced a capital raise of $27.5 million (before costs) to support the ongoing clinical activities and additional planned activities, funding the Company into 2027. The capital raise comprises a successful institutional placement raising $25.0 million (before costs) and a Share Purchase Plan seeking to raise an additional $2.5 million. The Placement was strongly supported by existing and new institutional and sophisticated investors in Australia and offshore.

Financial update

Amplia finished the June 2025 quarter with a cash position of $7.0 million (March 2025: $10.9 million).

During the quarter, the Company had net operating cash outflows of $3.8 million in relation to operating activities (March 2025: $2.7 million). Operating cashflows included:

• Outflows of $0.9 million for staff and administration/corporate costs; and • Outflows of $3.0 million for research and development costs, which primarily related to trial costs, Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the ACCENT Phase 2 clinical trial for narmafotinib (AMP945) with gemcitabine and Abraxane and initiation costs with its AMPLICITY Phase 2 study clinical trial for narmafotinib (AMP945) with FOLFIRINOX.

The Company is also expecting to receive its Research and Development Tax Incentive refund for the year ended 31 March 2025 of $3.8m in the September 2025 quarter.

On July 31, 2025 Immunophotonics, Inc., a clinical-stage biotech company developing novel immunostimulatory drugs to improve efficacy of routine tumor destruction techniques, reported the completion of treatment of the last patient in its INJECTABL-1 multicenter Phase 1b/2a clinical trial of IP-001 for advanced solid tumors (Press release, Immunophotonics, JUL 31, 2025, View Source [SID1234654693]). The 41-patient trial, which focused on three distinct cancer types — colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma— was conducted in France, Germany, Switzerland, the UK, and the US.

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The INJECTABL-1 trial was designed to evaluate the systemic immune-mediated anti-cancer effects of IP-001 following tumor ablation, which aims to destroy all cells in targeted tumor lesions in patients with advanced solid tumors but fails to induce robust anti-tumor immunity. Tumor ablation is an approved and well-established procedure that is readily available at most hospitals and clinics. IP-001 is a novel immunotherapy administered by injection into the ablation zone. It works by retaining tumor debris, including tumor antigens, and by activating the patient’s own immune system to allow systemic tumor surveillance. Such immune surveillance enables the patient’s own defense mechanisms to recognize and destroy tumor cells that had escaped the destroyed metastatic lesion.

Prof. Dr. Markus Jörger, Principal Investigator for the trial at the Cantonal Hospital St. Gallen Clinic for Medical Oncology and Hematology, commented: "We are proud to announce the completion of treatment of the last patient in our INJECTABL-1 Phase 1b/2a clinical trial. This significant milestone brings us closer to potentially providing a new treatment option for patients with advanced solid tumors."

"Immunophotonics is committed to leading the field of Interventional Immuno-Oncology through a therapeutic approach intended to reduce tumor recurrence after standard-of-care local ablation therapy, which remains a significant unmet medical need. With the completion of our INJECTABL-1 trial, we will evaluate data to assess IP-001’s ability to transform ablation into something more powerful as we continue to advance the clinical development of our proprietary novel asset. Early signals are positive, and the company has expanded clinical collaborations to further assess the efficacy of this novel therapy," stated Lu Alleruzzo, Immunophotonics co-founder and CEO.

About IP-001
IP-001 is a proprietary glycan polymer that generates tumor antigen depots and acts as a potent, multimodal immune stimulant intended to induce immunological responses to eradicate cancer. IP-001 is designed to (1) prolong the availability of the targeted tumor antigens, (2) facilitate the recruitment and activation of innate immune cells such as antigen-presenting cells (APCs), (3) increase the uptake of the tumor antigens into the APCs, and (4) lead to a downstream adaptive immune response against the tumor cells. Activation of a systemic, adaptive immune response allows immune effector cells to seek out and eliminate tumor cells throughout the body.

On July 31, 2025 Biogen Inc. (NASDAQ: BIIB) reported second quarter 2025 financial results (Press release, Biogen, JUL 31, 2025, View Source [SID1234654669]). Commenting on the results, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We delivered another quarter of strong execution against our strategy to transform our portfolio and build the new Biogen. Our performance reflects robust financial results, ongoing cost discipline, continued growth of our launch products, and meaningful strides expanding and advancing our late-stage pipeline. We are now progressing salanersen to registrational studies in SMA following exciting interim Phase 1b results, and have initiated all three Phase 3 studies for felzartamab in rare kidney disease. These achievements reinforce our commitment to building a stronger company, with the potential for sustainable growth and long-term value for our shareholders."

Financial Highlights
Q2 ’25 Q2 ’24 △
r (CC*)
Total Revenue (in millions) $2,646 $2,465 7% 8%
GAAP diluted EPS $4.33 $4.00 8% N/A
Non-GAAP diluted EPS $5.47 $5.28 4% 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.

Second quarter 2025 GAAP and Non-GAAP diluted EPS reflects the approximately ($0.26) impact from $47 million of acquired IPR&D, upfront and milestone expense.

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) Q2 ’25 Q2 ’24 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,107 $1,150 (4)% (4)%
Rare disease revenue(2)
$543 $534 2% 3%
Biosimilars revenue $182 $198 (8)% (8)%
Other product revenue(3)
$47 $18 169% 170%
Total product revenue $1,879 $1,900 (1)% (1)%
Revenue from anti-CD20 therapeutic programs $467 $445 5% 5%
Alzheimer’s collaboration revenue(4)
$55 $12 NMF NMF
Contract manufacturing, royalty and other revenue $245 $109 124% 119%
Total revenue $2,646 $2,465 7% 8%

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.
Expense Summary
(in millions) Q2 ’25 Q2 ’24 △
GAAP cost of sales*
$605 $546 (11)%
% of Total Revenue 23% 22%
Non-GAAP cost of sales*
$554 $504 (10)%
% of Total Revenue 21% 20%
GAAP R&D expense $399 $505 21%
Non-GAAP R&D expense $394 $455 13%
GAAP SG&A expense $584 $554 (5)%
Non-GAAP SG&A expense $579 $542 (7)%
GAAP acquired IPR&D, upfront and milestone expense $47 $9 NMF
Non-GAAP acquired IPR&D, upfront and milestone expense $47 $9 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

2

•The increase in second quarter 2025 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix, particularly the year-over-year increase in contract manufacturing revenue driven in-part by accelerated batch production in preparation for expected plant maintenance shutdowns in the fourth quarter of 2025, partially offset by an increase in launch product revenue.

•The decrease in second quarter 2025 GAAP and Non-GAAP R&D expense was driven primarily by savings from the Company’s R&D prioritization, Fit for Growth initiatives and R&D funding received.

•The increase in second 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.

•Second quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $47 million and includes a $30 million milestone to MorphoSys AG as part of the initiation of the Phase 3 trial of felzartamab in IgA nephropathy and a $16 million upfront payment as part of a strategic research agreement with City Therapeutics, Inc.
Other Financial Highlights

•Second quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $75 million, which includes approximately $57 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $18 million related to Biogen’s collaboration with Sage Therapeutics, Inc. and the commercialization of ZURZUVAE in the U.S.

•Second quarter 2025 GAAP other expense was approximately $49 million, primarily driven by net interest expense and impacts from foreign currency. Second quarter 2025 Non-GAAP other expense was approximately $57 million, primarily driven by net interest expense.

•Second quarter 2025 GAAP and Non-GAAP effective tax rates were 14.7% and 13.5%, respectively. Second quarter 2024 GAAP and Non-GAAP effective tax rates were 16.5% and 15.9%, respectively.
Financial Position

•Second quarter 2025 net cash flow from operations was approximately $161 million and includes the impact of cash tax payments of approximately $745 million. Capital expenditures were approximately $27 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $134 million.

•As of June 30, 2025, Biogen had cash and cash equivalents totaling approximately $2.8 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $3.5 billion.

•For the second quarter of 2025 the Company’s weighted average diluted shares were approximately 147 million.

On July 31, 2025 Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") reported that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative drug CS231295 tablet for the treatment of advanced solid tumors (Press release, Shenzhen Chipscreen Biosciences, JUL 31, 2025, View Source [SID1234654694]). This significant milestone marks a key step forward in the global development strategy for CS231295.

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Malignant tumors remain one of the leading causes of death worldwide. Despite continuous advancements in clinical treatments and efficacy, most cancers remain incurable. Drug resistance, recurrence, and metastasis pose significant threats to long-term patient survival. In particular, due to the presence of the blood-brain barrier, primary brain tumors and brain metastases not only pose a severe danger to life but also serve as natural barriers to effective drug therapy. Thus, developing novel brain-penetrant anti-cancer drugs has become a pressing challenge and a key research focus.

CS231295 is a next-generation brain-penetrant Aurora B selective inhibitor discovered through years of mechanism-based research by Chipscreen Biosciences. On one hand, it precisely inhibits tumor-specifically overexpressed Aurora B kinase to induce synthetic lethality, directly targeting the genetic vulnerability of hard-to-treat cancers such as those with RB1 deletion. On the other hand, due to its strong blood-brain barrier permeability, it shows significant therapeutic potential for both primary and metastatic brain tumors. Furthermore, this molecule also exhibits broad-spectrum anti-tumor activity, which improves the tumor microenvironment. It is expected to provide a novel solution for tumors with similar genetic defects and the global challenge of brain metastases. Currently, there is no similar compound with this design that has entered clinical trials globally.

With its unique mechanism and chemical structure, CS231295 demonstrates synergistic effects when combined with chemotherapy, targeted therapy, and cancer immunotherapy. In preclinical studies, CS231295 has shown remarkable pharmacodynamic activity, ideal pharmacokinetic properties, and a favorable safety profile.

Notably, CS231295 completed the first patient enrollment in its Phase I first-in-human clinical trial in China in May 2025, providing preliminary evidence to support the scientific rationale and feasibility of global multicenter clinical development. The FDA’s IND approval will further accelerate the initiation and implementation of its clinical research in the United States.

On July 31, 2025 Bristol Myers Squibb (NYSE: BMY) reported results for the second quarter of 2025 (Press release, Bristol-Myers Squibb, JUL 31, 2025, View Source [SID1234654670]).

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"We are making good progress rewiring the company for long-term growth. In the second quarter, we delivered strong results across our Growth Portfolio, continued to optimize our cost structure, and added to our innovative pipeline with strategic partnerships," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "In the back half of the year, we’re focused on advancing transformational medicines and delivering on our Growth Portfolio and important pipeline opportunities to shape our growth trajectory."

Second Quarter Results
$ in millions, except per share amounts 2025 2024 Change
Change Excl. FX**
Total Revenues $12,269 $12,201 1 % 0 %
Earnings/(Loss) Per Share – GAAP* 0.64 0.83 (22) % N/A
Earnings/(Loss) Per Share – Non-GAAP* 1.46 2.07 (29) % N/A
Acquired IPRD Charge and Licensing Income Net Impact on Earnings/(Loss) Per Share (0.57) (0.04) N/A N/A

SECOND QUARTER RESULTS
All comparisons are made versus the same period in 2024 unless otherwise stated.
•Growth Portfolio revenues of $6.6 billion increased 18%, or 17% Ex-FX. Revenue growth was primarily driven by our immuno-oncology (IO) portfolio, Breyanzi, Reblozyl and Camzyos, and reflects the continued strength of Cobenfy.
•Legacy Portfolio revenues of $5.7 billion decreased 14%, or 15% Ex-FX. Demand increased for Eliquis, offset by expected continued generic impact across the remainder of the Legacy Portfolio, as well as the impacts from U.S. Medicare Part D redesign.
•Total revenues of $12.3 billion increased 1%, and were relatively flat Ex-FX.
◦U.S. revenues of $8.5 billion decreased 3%.
◦International revenues of $3.8 billion increased 10%, or 8% Ex-FX.
SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS(d)

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

U.S.
Int’l
WW(c)
U.S.
Int’l
WW(c)
Int’l
WW(c)
Growth Portfolio
Opdivo $ 1,506 $ 1,053 $ 2,560 7 % 7 % 7 % 7 % 7 %
Opdivo Qvantig 28 1 30 N/A N/A N/A N/A N/A
Orencia 711 252 963 (4) % 23 % 2 % 20 % 1 %
Yervoy 451 277 728 12 % 22 % 16 % 21 % 15 %
Reblozyl 453 114 568 30 % 51 % 34 % 46 % 33 %
Opdualag 252 32 284 13 % 161 % 21 % 155 % 20 %
Breyanzi 255 88 344 110 % 183 % 125 % 167 % 122 %
Camzyos 214 46 260 65 % >200% 87 % >200% 86 %
Zeposia 105 46 150 (5) % 15 % — % 10 % (2) %
Abecma 47 40 87 (14) % (1) % (8) % (7) % (11) %
Sotyktu 43 27 70 5 % 116 % 31 % 109 % 29 %
Krazati 47 2 48 58 % (32) % 51 % (33) % 51 %
Cobenfy 35 — 35 N/A N/A N/A N/A N/A
Other Growth Products(a)
201 269 470 15 % 56 % 35 % 55 % 35 %
Total Growth Portfolio
4,348 2,248 6,596 15 % 24 % 18 % 23 % 17 %
Legacy Portfolio
Eliquis 2,654 1,027 3,680 4 % 18 % 8 % 12 % 6 %
Revlimid 732 106 838 (37) % (44) % (38) % (44) % (38) %
Pomalyst/Imnovid 584 124 708 (18) % (49) % (26) % (51) % (27) %
Sprycel 68 52 120 (80) % (38) % (72) % (38) % (72) %
Abraxane 33 72 105 (79) % (7) % (55) % (5) % (54) %
Other Legacy Products(b)
100 123 223 5 % (4) % (1) % (5) % (1) %
Total Legacy Portfolio
4,171 1,503 5,673 (17) % (6) % (14) % (9) % (15) %
Total Revenues $ 8,519 $ 3,750 $ 12,269 (3) % 10 % 1 % 8 % — %

** See "Use of Non-GAAP Financial Information".
(a) Includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenue.
(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

SECOND 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 June 30, 2025 Three Months Ended June 30, 2024
($ amounts in millions)
GAAP
Specified Items**
Non-GAAP
GAAP
Specified Items**
Non-GAAP
Cost of products sold
$ 3,372 (16) $ 3,356 $ 3,267 (296) $ 2,971
Gross margin(a)
72.5 % 72.6 % 73.2 % 75.6 %
Selling, general and administrative
1,713 (22) 1,691 1,928 (6) 1,922
Research and development
2,580 (318) 2,263 2,899 (604) 2,295
Acquired IPRD
1,508 — 1,508 132 — 132
Amortization of acquired intangible assets
830 (830) — 2,416 (2,416) —
Other (income)/expense, net
494 (602) (108) 273 (277) (4)
Effective tax rate
25.9 % (9.8) % 16.1 % (30.9) % 45.0 % 14.1 %

**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 decreased from 73.2% to 72.5% on a GAAP basis, and from 75.6% to 72.6% on a non-GAAP basis, primarily due to product mix.
•Selling, general and administrative expenses of $1.7 billion decreased 11% on a GAAP basis and 12% on a non-GAAP basis, primarily driven by our ongoing strategic productivity initiative.
•Research and development expenses of $2.6 billion decreased 11% on a GAAP basis, primarily due to lower IPRD impairment charges. Non-GAAP research and development expenses of $2.3 billion decreased 1%, primarily driven by our ongoing strategic productivity initiative.
•Acquired IPRD charges of $1.5 billion increased from $132 million on a GAAP and non-GAAP basis, primarily driven by the execution of a strategic partnership with BioNTech in June 2025.
•Amortization of acquired intangible assets of $830 million decreased 66% on a GAAP basis, primarily due to lower amortization expense related to Revlimid.
•Effective tax rate in 2025 on a GAAP and non-GAAP basis was 25.9% and 16.1%, respectively. The 2024 GAAP effective tax rate was impacted by the release of income tax reserves.
•Net income attributable to Bristol Myers Squibb of $1.3 billion, or $0.64 per share, decreased from $1.7 billion, or $0.83 per share, on a GAAP basis. On a non-GAAP basis, net income attributable to Bristol Myers Squibb of $3.0 billion, or $1.46 per share, decreased from $4.2 billion, or $2.07 per share. GAAP and non-GAAP EPS include the impacts of Acquired IPRD.

PRODUCT AND PIPELINE UPDATES
Entries organized by date and inclusive of second quarter and recent updates.
Asset(s)
Date Announced
Milestone
Sotyktu (deucravacitinib)
July 21
The U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Sotyktu based on positive results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials for the treatment of adults with active psoriatic arthritis. The FDA assigned a Prescription Drug User Fee Act goal date of March 6, 2026.

In addition, China’s Center for Drug Evaluation of National Medical Products Administration and Japan’s Ministry of Health, Labour and Welfare accepted sNDAs for Sotyktu in the same indication. The European Medicines Agency (EMA) has also validated the Type II variation application to expand the indication for Sotyktu to include this disease.
Reblozyl (luspatercept)
July 18
The Phase 3 INDEPENDENCE trial evaluating Reblozyl with concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusions did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within the first 24 weeks of treatment, compared to placebo. Patients saw a numerical and clinically meaningful improvement in RBC transfusion independence favoring Reblozyl, in line with previous results from the Phase 2 trial.

The company will engage with the FDA and EMA, and plans to engage other health authorities to discuss the submission of marketing applications.
Eliquis (apixaban)
July 17
The BMS-Pfizer Alliance announced a new direct-to-patient option for purchasing Eliquis via the Alliance’s patient resource, Eliquis 360 Support. This option offers uninsured, underinsured or self-pay patients an opportunity to significantly lower out-of-pocket costs for Eliquis.
Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel)
June 26
The FDA approved label updates for CAR T cell therapies Breyanzi and Abecma that reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that were in place since each product was initially approved.
Breyanzi June 16
Primary analysis results of the marginal zone lymphoma cohort of the Phase 2 TRANSCEND FL study evaluating Breyanzi in patients with relapsed or refractory disease demonstrated high rates of durable responses and a consistent safety profile in a fifth cancer type.
Subcutaneous formulation of Opdivo (nivolumab)
May 28
The European Commission (EC) approved a new Opdivo formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form, and a new strength. Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
Opdivo
May 16
The EC approved the perioperative regimen of neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.

Business Development
The company recently entered into multiple transactions that enhanced its portfolio and pipeline.
In June 2025, the company entered into an agreement with BioNTech for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.
Also in June 2025, RayzeBio, Inc., a Bristol Myers Squibb company, entered into a definitive agreement under which Philochem AG, a wholly-owned subsidiary of the Philogen Group, will license the exclusive worldwide rights to develop, manufacture and commercialize OncoACP3, a clinical-stage therapeutic and diagnostic agent targeting prostate cancer, to RayzeBio. The transaction is expected to close in the third quarter of 2025 following the receipt of necessary regulatory approvals and the satisfaction of other customary closing conditions.
In July 2025, the company announced the creation of a new, independent biopharmaceutical company with Bain Capital focused on developing new therapies for autoimmune diseases that address significant unmet needs of patients. The newly formed company launches with five immunology assets in-licensed from Bristol Myers Squibb and a $300 million financing commitment that was led by Bain Capital.
Financial Guidance
Bristol Myers Squibb is increasing its full-year 2025 non-GAAP revenue guidance from a range of approximately $45.8 billion to $46.8 billion, to a range of approximately $46.5 billion to $47.5 billion, reflecting the strength of the Growth Portfolio, better-than-expected Legacy Portfolio sales in the second quarter, and a favorable impact of approximately $200 million related to foreign exchange rates.
Full-year operating expense expectations are now approximately $16.5 billion, reflecting the investment behind recent business development transactions and the identification of additional investment opportunities within our Growth Portfolio. The company now anticipates other income and expense in 2025 to be approximately $250 million of income due to higher-than-anticipated royalties and favorable interest income.
Non-GAAP EPS is now expected to be in the range of $6.35 – $6.65, inclusive of an unfavorable $(0.57) per share impact from the BioNTech Acquired IPRD charge this quarter.
5

Non-GAAP2,3

April
(Prior)
July
(Updated)4
Total Revenues
(Reported & Ex-FX)
~$45.8 – $46.8 billion
~$46.5 – $47.5 billion
Gross Margin %
~72%
No change
Operating Expenses1
~$16.2 billion
~$16.5 billion
Other income/(expense)
~$100 million
~$250 million
Effective tax rate
~18%
No change
Diluted EPS $6.70 – $7.00
$6.35 – $6.65
BioNTech Acquired IPRD Charge Included in Diluted EPS
— $(0.57)

1 Operating Expenses = SG&A and R&D.
2 See "Use of Non-GAAP Financial Information."
3 April was calculated using foreign exchange rates as of April 23, 2025, and July was calculated using foreign
exchange rates as of July 25, 2025.
4 Guidance includes Acquired IPRD charges through Q2 2025, and does not include Acquired IPRD either incurred,
or expected to be incurred, after June 30, 2025.

The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges and licensing income, including any potential Acquired IPRD charges associated with the Philochem transaction, which is expected to close in the third quarter of 2025, subject to customary closing conditions. 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.

A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on
6

various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."

Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, July 31, 2025, at 8:00 a.m. ET, during which company executives will review financial results with the investment community.
Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source Materials related to the call will be available at View Source prior to the start of the conference call.
A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.