On October 30, 2025 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the third quarter ended September 30, 2025 and provided a business update.

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"The third quarter of 2025 celebrated the FDA approval of BRINSUPRI and the availability of our second commercial product, underscoring our team’s dedication to bringing forward a first-in-disease therapy for patients with non-cystic fibrosis bronchiectasis. While still early in the U.S. BRINSUPRI launch, we are very encouraged by positive feedback received from both physicians and patients," said Will Lewis, Chair and Chief Executive Officer of Insmed. "This achievement is just the beginning of numerous commercial and clinical catalysts anticipated over the next 18 months across our late-stage programs – ARIKAYCE, brensocatib, and TPIP – and our growing clinical pipeline of first- or best-in-class therapies. With these opportunities ahead, our team is more dedicated than ever to transforming the lives of patients with serious diseases."

Recent Progress and Anticipated Milestones by Program:

ARIKAYCE

•
ARIKAYCE global revenue grew 22% in the third quarter of 2025 compared to the third quarter of 2024, reflecting year-over-year growth across all geographic regions.

•
The Company anticipates the topline readout of the Phase 3 ENCORE trial in the first half of 2026 in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.

•
Assuming successful results from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.

Brensocatib

•
In August 2025, the FDA approved the Company’s New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis (NCFB). BRINSUPRI (brensocatib 25mg and 10mg tablets) was subsequently launched commercially in the U.S.

•
In October 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of BRINSUPRI (brensocatib 25mg tablets) for the treatment of NCFB in the European Union (EU).

•
Regulatory submissions for brensocatib for patients with bronchiectasis in the United Kingdom (UK) and Japan have been accepted. Insmed anticipates commercial launches for the EU, UK, and Japan in 2026, pending approval in each territory.

•
Insmed expects to report topline data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by early January 2026.

•
In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed now expects to report topline data from CEDAR in the first half of 2026.

TPIP

•
Insmed anticipates initiating PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.

•
Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.

•
The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

Gene Therapy

•
Insmed completed dosing of the first cohort in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

•
The Company’s Investigational New Drug (IND) filing for INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic lateral sclerosis (ALS), has been cleared by the FDA.

•
Insmed’s third gene therapy candidate targeting Stargardt disease is currently advancing toward the clinic, with an IND filing expected in the first half of 2026.

Pre-Clinical Programs

•
Insmed’s research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.

•
The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.

•
Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

Corporate Updates

•
In September 2025, Insmed presented seven abstracts from across its portfolio at the European Respiratory Society (ERS) Congress 2025.

•
In October 2025, Insmed presented six abstracts from across its portfolio at the American College of Chest Physicians (CHEST) 2025 Annual Meeting.

•
In October 2025, Insmed announced that it has earned the No. 1 ranking in Science’s 2025 Top Employers Survey, marking the fifth consecutive year in which Insmed achieved the top ranking. The annual survey polls employees in biotechnology, pharmaceutical, and related industries to determine the 20 best employers, as well as their driving characteristics.

Third-Quarter 2025 Financial Results

The following table summarizes Insmed’s third-quarter and year-to-date 2025 and 2024 revenues and revenue growth across all commercial regions:

Three Months Ended
September 30,

Nine Months Ended
September 30,

(in millions)

2025

2024

Growth

2025

2024

Growth

ARIKAYCE

U.S.

$
74.0

$
66.9

11
%

$
206.9

$
187.0

11
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
114.3

$
93.4

22
%

$
314.5

$
259.3

21
%
BRINSUPRI

U.S.

$
28.1

$
–

N/A

$
28.1

$
–

N/A

International

–

–

N/A

–

–

N/A

Total

$
28.1

$
–

N/A

$
28.1

$
–

N/A

Total Revenues

U.S.

$
102.0

$
66.9

53
%

$
235.0

$
187.0

26
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
142.3

$
93.4

52
%

$
342.6

$
259.3

32
%

•
Cost of product revenues (excluding amortization of intangibles) was $29.4 million for the third quarter of 2025, compared to $21.2 million for the third quarter of 2024. The increase in cost of product revenues primarily reflects growth in ARIKAYCE sales and BRINSUPRI sales.

•
Research and development (R&D) expenses were $186.4 million for the third quarter of 2025, compared to $150.8 million for the third quarter of 2024. The increase in R&D expenses was primarily related to increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as clinical development and research costs, and manufacturing costs.

•
Selling, general and administrative (SG&A) expenses for the third quarter of 2025 were $186.4 million, compared to $118.9 million for the third quarter of 2024. The increase in SG&A expenses was primarily related to increases in professional fees and other external expenses, as well as increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, both driven by commercial readiness and commercial activities for BRINSUPRI.

•
For the third quarter of 2025, Insmed reported a net loss of $370.0 million, or $1.75 per share, compared to a net loss of $220.5 million, or $1.27 per share, for the third quarter of 2024.

Balance Sheet, Financial Guidance, and Planned Investments

•
As of September 30, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.7 billion.

•
Insmed is raising its full-year 2025 global ARIKAYCE revenue guidance to a range of $420 million to $430 million, from a range of $405 million to $425 million previously, representing a range of 15% to 18% year-over-year growth compared to 2024.

•
The Company plans to continue to invest in the following key activities in 2025:

(i)
commercialization and expansion of BRINSUPRI in the U.S., with advancement of regulatory submissions for brensocatib in Europe, the UK, and Japan;

(ii)
commercialization and expansion of ARIKAYCE globally;

(iii)
advancement of clinical trial programs for brensocatib, including the ongoing Phase 2b BiRCh study in patients with CRSsNP and the Phase 2b CEDAR study in patients with HS;

(iv)
advancement of the Phase 3 ENCORE study for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung disease;

(v)
advancement of clinical development programs for TPIP, including the initiation of a Phase 3 study in patients with PH-ILD and preparations for separate Phase 3 studies in patients with PAH, PPF, and IPF;

(vi)
advancement of the Phase 1 ASCEND study for INS1201 in DMD; and

(vii)
continued development of its pre-clinical research programs.

Conference Call

Insmed will host a conference call beginning today, October 30, 2025, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through November 6, 2025, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

(Press release, Insmed, OCT 30, 2025, View Source [SID1234657153])

On October 30, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that it has been invited to present a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, at the 2025 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), being held November 5-7, 2025 in Cape Town, South Africa.

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IMNN-001, based on IMUNON’s proprietary TheraPlas technology platform, is an interleukin-12 (IL-12) DNA plasmid vector incorporated in a nanoparticle delivery system, enabling cell transfection followed by persistent, local production and secretion of the IL-12 protein in the tumor microenvironment. IMNN-001 is the first therapy to achieve a clinically effective response in advanced (stage IIIC/IV) ovarian cancer including benefits in both progression-free survival (PFS) and overall survival (OS) in a first-line treatment setting when used with standard of care chemotherapy.

"We are very pleased that we have been invited to present on our ongoing OVATION 3 Study at two prestigious conferences in the oncology field," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "It is very encouraging to see the strong interest in our promising and novel IMNN-001 DNA-mediated immunotherapy among the global scientific community, and the acceptance of our TiP poster at both IGCS and ESMO (Free ESMO Whitepaper) 2025 is further validation of our therapy’s significant potential to transform the treatment of advanced ovarian cancer. Our clinical success thus far has attracted increasing interest from both clinical investigators and patients, and we continue to make meaningful progress as we advance enrollment in the Phase 3 trial as quickly as possible."

The Company treated the first patient in the pivotal Phase 3 OVATION 3 Study in July 2025 and is working with trial investigators to expand clinical sites and accelerate enrollment. Four sites have been activated to date and are open for patient enrollment, with up to 46 additional sites being considered for activation.

Details of the IGCS 2025 poster presentation are as follows:

Abstract Title: OVATION-3: A randomized phase III trial evaluating the safety and efficacy of intraperitoneal IL-12 gene therapy administered in combination with standard neoadjuvant and adjuvant chemotherapy in newly-diagnosed patients with advanced epithelial ovarian cancer

Presenting Author: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON

Poster Number: TP014/#750

About the OVATION 3 Study
OVATION 3 is IMUNON’s pivotal Phase 3 study of IMMN-001, an IL-12 gene-mediated immunotherapy, in women with advanced epithelial ovarian cancer. The study is supported with unprecedented OS data from a large, 112-patient, randomized Phase 2 study showing the following:

Median 13-month increase in OS (HR 0.70) and median 3-month increase in PFS (HR 0.79) in IMNN-001 treatment arm compared to standard of care alone.
Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect.
Use of poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in the IMNN-001 treatment arm as patients surpass 5 years since randomization in the trial compared to median OS of 37 months on standard of care (HR 0.42).

The results from the OVATION 2 Study have resulted in invitations to present data from the Phase 2 Study at both the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) annual meetings in 2025 and in the peer-reviewed journal Gynecologic Oncology.

The OVATION-3 trial is a robustly designed clinical study with at least 95% statistical power on the primary endpoint of overall survival. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for FDA submission of an IMNN-001 BLA if the primary endpoint reaches statistical significance. OVATION 3 is currently enrolling patients at four trial sites with up to 46 additional sites being considered for activation.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response score.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, OCT 30, 2025, View Source [SID1234657152])

On October 30, 2025 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the third quarter of fiscal year 2025.

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"I am pleased to announce that the Illumina team delivered Q325 results that exceeded the high-end of our guidance range for revenue and earnings, driven by revenue acceleration in clinical, our largest market segment," said Jacob Thaysen, Chief Executive Officer. "During the quarter, we returned to growth ex-China and are executing on our strategic pillars that support our long-range financial targets."

Third quarter results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q3 2025 Q3 2024 Q3 2025 Q3 2024
Revenue
$ 1,084 $ 1,080 $ 1,084 $ 1,080
Gross margin
67.6 % 68.9 % 69.2 % 70.5 %
Research and development (R&D) expense $ 229 $ 253 $ 228 $ 249
Selling, general and administrative (SG&A) expense $ 277 $ 239 $ 256 $ 268
Legal contingency and settlement $ — $ (488) $ — $ —
Operating profit
$ 227 $ 741 $ 265 $ 244
Operating margin 21.0 % 68.6 % 24.5 % 22.6 %
Tax provision $ 70 $ 77 $ 47 $ 48
Tax rate 31.8 % 10.8 % 18.6 % 21.0 %
Net income $ 150 $ 642 $ 206 $ 181
Diluted EPS $ 0.98 $ 4.03 $ 1.34 $ 1.14

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.

Capital expenditures for free cash flow purposes were $31 million for Q3 2025. Cash flow provided by operations was $284 million, compared to $316 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $253 million for the quarter, compared to $284 million in the prior year period. Depreciation and amortization expense was $67 million for Q3 2025. At the close of the quarter, the company held $1.28 billion in cash, cash equivalents and short-term investments.

Key announcements since our last earnings release
•Launched 5-base solution, enabling simultaneous genomic and epigenomic insights
•Introduced Constellation mapped read technology, uncovering hard-to-see genomic variants in GeneDx pilot
•Launched BioInsight, a new business to accelerate technology and data-driven discovery initiatives
•Expanded personalized cancer care efforts through new pharmaceutical development partnerships enabled on the TruSight Oncology (TSO) Comprehensive genomic profiling test
•Welcomed Alnylam Pharmaceuticals to the Alliance for Genomic Discovery (AGD), broadening the consortium’s diverse clinical genomic dataset and utilizing it to inform development of ‘gene silencing’ medicines
•Introduced Illumina Protein Prep, driving deeper proteomic insights to enhance drug discovery and development, with a streamlined sample-to-insights solution for discovery and clinical research

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, 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.

Conference call information
The conference call will begin at 1:30 pm Pacific Time (4:30 pm Eastern Time) on Thursday, October 30, 2025. Interested parties may access the live webcast via the Investor Info section of Illumina’s website or directly through the following link – View Source To ensure timely connection, please join at least ten minutes before the scheduled start of the call. A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

(Press release, Illumina, OCT 30, 2025, View Source [SID1234657151])

On October 30, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported its third quarter 2025 results of operations.

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"We continue to deliver on Gilead’s robust portfolio with a strong start for Yeztugo, rapidly growing uptake of Biktarvy, Descovy and Livdelzi, and positive data for Trodelvy in 1L metastatic triple negative breast cancer," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "With multiple potential product launches in 2026, the strongest clinical pipeline in Gilead’s history, and no major loss of exclusivity expected until 2036, we are well-positioned to drive positive impact for patients and continued growth of our business."
Third Quarter 2025 Financial Results
•Total third quarter 2025 revenues increased 3% to $7.8 billion compared to the same period in 2024, broken down as follows:
◦Total third quarter 2025 product sales decreased 2% to $7.3 billion compared to the same period in 2024, primarily driven by lower Veklury (remdesivir) and Cell Therapy sales, partially offset by higher HIV and Livdelzi (seladelpar) sales.
◦Total third quarter 2025 royalty, contract and other revenues increased by approximately $400 million compared to the same period in 2024, primarily driven by revenue related to a previous sale of intellectual property not expected to reoccur.
•Diluted earnings per share ("EPS") was $2.43 in the third quarter 2025 compared to $1.00 in the same period in 2024. The increase was primarily driven by a prior year pre-tax in-process research and development ("IPR&D") impairment charge of $1.75 billion that did not repeat in the current period, as well as the $400 million increase in other revenue mentioned above, lower acquired IPR&D expenses and higher net unrealized gains on equity investments in the current period, partially offset by higher tax expense.
•Non-GAAP diluted EPS of $2.47 in the third quarter 2025 compared to $2.02 in the same period in 2024. The increase was primarily driven by the $400 million increase in other revenue mentioned above and lower acquired IPR&D expenses.
•As of September 30, 2025, Gilead had $9.4 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024.
•During the third quarter 2025, Gilead generated $4.1 billion in operating cash flow.
•During the third quarter 2025, Gilead paid dividends of $1.0 billion and repurchased $435 million of common stock.
Third Quarter 2025 Product Sales
Total third quarter 2025 product sales decreased 2% to $7.3 billion compared to the same period in 2024. Total third quarter 2025 product sales excluding Veklury increased 4% to $7.1 billion compared to the same period in 2024, primarily due to higher HIV and Livdelzi sales, partially offset by lower Cell Therapy sales.

October 30, 2025

HIV product sales increased 4% to $5.3 billion in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price.
•Biktarvy (bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 6% to $3.7 billion in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price.
•Descovy (FTC 200mg/TAF 25mg) sales increased 20% to $701 million in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand.
The Liver Disease portfolio sales increased 12% to $819 million in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand for Livdelzi.
Veklury sales decreased 60% to $277 million in the third quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations.
Cell Therapy product sales decreased 11% to $432 million in the third quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds.
•Yescarta (axicabtagene ciloleucel) sales decreased 10% to $349 million in the third quarter 2025 compared to the same period in 2024, primarily driven by lower demand.
•Tecartus (brexucabtagene autoleucel) sales decreased 15% to $83 million in the third quarter 2025 compared to the same period in 2024, primarily reflecting lower demand.
Trodelvy (sacituzumab govitecan-hziy) sales increased 7% to $357 million in the third quarter 2025 compared to the same period in 2024, primarily driven by higher demand.
Third Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin remained relatively flat at 78.6% in the third quarter 2025 compared to 79.1% in the same period in 2024. Non-GAAP product gross margin also remained relatively flat at 86.5% in the third quarter 2025 compared to 86.8% in the same period in 2024.
•Research and development ("R&D") expenses and non-GAAP R&D expenses were $1.3 billion in the third quarter 2025 compared to $1.4 billion in the same period in 2024, decreasing primarily due to lower study-related and clinical manufacturing expenses.
•Acquired IPR&D expenses were $170 million in the third quarter 2025, primarily related to a $120 million upfront payment related to our collaboration with Shenzhen Pregene Biopharma Co., Ltd. ("Pregene").
•Selling, general and administrative ("SG&A") expenses and non-GAAP SG&A expenses of $1.4 billion in the third quarter 2025 remained relatively flat compared to the same period in 2024, with lower corporate expenses being largely offset by higher HIV promotional expenses.
•The effective tax rate ("ETR") was 16.2% in the third quarter 2025 compared to (31.1)% in the same period in 2024, primarily driven by the prior year impact of a legal entity restructuring and the aforementioned IPR&D impairment charge that did not repeat in the current period. The non-GAAP ETR was 17.5% in both the third quarter 2025 and the same period in 2024.

October 30, 2025

Guidance and Outlook
For the full-year, Gilead expects:
(in millions, except per share amounts)
October 30, 2025 Guidance
Low End High End Comparison to Prior Guidance
Product sales $ 28,400 $ 28,700
Previously $28,300 to $28,700
Product sales excluding Veklury $ 27,400 $ 27,700
Previously $27,300 to $27,700
Veklury $ 1,000 $ 1,000
Unchanged
Diluted EPS $ 6.65 $ 6.85
Previously $5.85 to $6.15
Non-GAAP diluted EPS $ 8.05 $ 8.25
Previously $7.95 to $8.25

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.
Key Updates Since Our Last Quarterly Release
Virology
•Announced settlement agreements to resolve Biktarvy patent litigation with generic manufacturers Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd. Under the agreements, the earliest date the three generic manufacturers can market a generic version of full dose Biktarvy in the U.S. is April 1, 2036, subject to standard acceleration provisions. This is more than two years later than our previous loss of exclusivity projection for Biktarvy (December 2033).
•Received a strong recommendation for the use of twice-yearly injectable Yeztugo (lenacapavir) for HIV pre-exposure prophylaxis ("PrEP") in the new U.S. Centers for Disease Control and Prevention guidelines.
•Announced a partnership with the U.S. State Department and the U.S. President’s Emergency Plan for AIDS Relief ("PEPFAR") to deliver lenacapavir for HIV PrEP for up to two million people over three years in countries supported by both PEPFAR and the Global Fund.
•Received European Commission marketing authorization for Yeytuo (lenacapavir) for use as PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk.
Oncology
•Presented Phase 3 ASCENT-03 data for Trodelvy in 1L metastatic triple-negative breast cancer ("mTNBC") patients who are not candidates for PD-1/PD-L1 checkpoint inhibitors at the 2025 European Society for Medical Oncology ("ESMO") Congress. Trodelvy is not approved in this setting.
•Presented overall survival results at ESMO (Free ESMO Whitepaper) from Arm A1 of the Phase 2 EDGE-Gastric study evaluating combination treatment of the Fc-silent anti-TIGIT domvanalimab plus the anti-PD-1 zimberelimab and chemo in people with advanced gastric or esophageal cancer that has spread or cannot be removed with surgery. Domvanalimab and zimberelimab are investigational and not approved in this setting.
Cell Therapy
•Announced the acquisition of Interius BioTherapeutics, Inc. ("Interius"), a privately held biotechnology company developing in vivo therapeutics.
Corporate
•The Board declared a quarterly dividend of $0.79 per share of common stock for the fourth quarter of 2025. The dividend is payable on December 30, 2025, to stockholders of record at the close of business on December 15, 2025. Future dividends will be subject to Board approval.

October 30, 2025

•Moody’s has affirmed Gilead’s A3 senior unsecured rating and upgraded the company’s outlook to positive from stable, citing the momentum in the product pipeline.
•Announced ground-breaking on a new Pharmaceutical Development and Manufacturing Technical Development Center in Foster City, California as part of a planned $32 billion investment in the U.S. through 2030.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.
Conference Call
At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

(Press release, Gilead Sciences, OCT 30, 2025, View Source [SID1234657150])

On October 30, 2025 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported updates for its Selective ARID1B, Selective CBP, and Selective EP300 degrader programs, which will be presented during a Foghorn-hosted virtual investor event.

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"We have made significant progress across our degrader portfolio, further highlighting our ability to address challenging and prevalent targets," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "Earlier this week, we presented new preclinical data at the TPD and Induced Proximity Summit demonstrating significant progress for our first-in-class Selective ARID1B degrader, with potential as a new therapy for endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer. Our Selective CBP degrader, with potential in EP300-mutant cancers and ER+ breast cancer, is advancing towards IND in 2026 and on track for non-GLP toxicology studies this quarter. Additionally, our Selective EP300 degrader shows encouraging anti-tumor efficacy with favorable tolerability in hematological malignancies in preclinical studies. This is particularly exciting in multiple myeloma where we believe we are significantly differentiated versus dual CBP/ EP300 programs. These advancements along with our continued innovation and disciplined execution are positioning Foghorn at the forefront in the field of targeted protein degradation."

Steven Bellon, Chief Scientific Officer of Foghorn, added, "ARID1B has long been difficult to selectively drug due to its high homology to ARID1A, lack of enzymatic activity, and its largely unstructured nature. Our demonstration of selective degradation of ARID1B represents a major scientific breakthrough that underscores the strength of our protein degrader capabilities to overcome challenges that have historically limited the field."
The live webcast for the investor presentation will be available under the Events & Presentations section of Foghorn’s website, and a replay of the event and presentation will be available immediately following the event.
Selective ARID1B Degrader Program

ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in up to 5% of all solid tumors including endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer (NSCLC). Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target.

Foghorn is developing a Selective ARID1B degrader that is advancing towards in vivo proof of concept in 2026. Key program updates include:
•Developed VHL and cereblon based bifunctional degraders with potential for oral delivery
•Selective degradation of ARID1B achieved
•Modulation of downstream target genes following ARID1B degradation
Data presented at the TPD and Induced Proximity Summit is available under the Science section of the Company’s website.
Selective CBP Degrader Program
CBP is an acetyltransferase that selectively targets a synthetic relationship established in EP300-mutated cancers, which includes endometrial, cervical, ovarian, bladder and colorectal cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity with EP300, and dose-limiting toxicities associated with dual inhibition of both CBP and EP300. CBP lineage dependencies are established in several cancers, including ER+ breast cancer.
Foghorn is advancing a Selective CBP degrader, on track to be Investigational New Drug (IND)-ready in 2026. Key updates include:
•Highly potent and selective lead candidate CBPd-171 advancing to dose range finding toxicology studies in Q4 2025
•Anti-tumor activity in EP300-mutant solid tumors and in CBP-dependent cancers, including promising potential in ER+ breast cancer
•No significant impact on platelet counts and megakaryocytes spared with CBPd-171 dosing
•Long Acting Injectable (LAI) formulation optimized for subcutaneous injection weekly or every
other week for convenient administration
Selective EP300 Degrader Program
EP300 is an acetyltransferase that is implicated in hematological malignancies such as multiple myeloma (MM) and diffuse large b-cell lymphoma (DLBCL), and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity with CBP, and dose-limiting toxicities associated with dual inhibition of both CBP and EP300.
Foghorn is advancing a Selective EP300 degrader program, with an initial focus in MM and DLBCL, on track for IND-enabling studies in 2026. Key updates include:
•Broad anti-tumor activity in over 70% of all heme sub-lineages tested
•VHL based selective degrader shows efficacy in MM without hematological toxicities, including thrombocytopenia
•EP300 degraders show efficacy in IMiD-resistant MM cell lines
•Tolerability profile with widespread potential for combinations

(Press release, Foghorn Therapeutics, OCT 30, 2025, View Source [SID1234657149])