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Jazz Pharmaceuticals Announces Third Quarter 2025 Financial Results and Updates 2025 Financial Guidance

On November 5, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the third quarter of 2025 and updated financial guidance for 2025.

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"Achieving the highest revenue quarter in Jazz’s history speaks to the strength of our diversified portfolio and the outstanding performance of our team. We were pleased to once again deliver solid execution across our sleep, epilepsy and oncology portfolios, led by double-digit percentage growth from Epidiolex and Xywav," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "In addition, we achieved several key milestones that will enhance our commercial portfolio, including receiving FDA approvals for Modeyso as well as the Zepzelca and atezolizumab first-line maintenance combination. We remain confident in the opportunity presented by zanidatamab and look forward to sharing the top-line data readout from the Phase 3 HERIZON-GEA-01 trial before the end of the year. With a proven portfolio and strong financial foundation, we are well-positioned to accelerate our evolution and deliver meaningful value for patients and shareholders alike."

Key Highlights

•Modeyso received accelerated approval from the FDA ahead of its PDUFA date; initiated commercial launch in August 2025 with strong initial uptake and sales of $11.0 million in 3Q25.
•Zepzelca and atezolizumab combination received FDA approval for 1L maintenance treatment of ES-SCLC based on positive data from the Phase 3 IMforte trial.
•Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25; updated intent-to-treat population for PFS to include all patients enrolled in the trial.
•Narrowed 2025 total revenue guidance range to $4.175 – $4.275 billion from $4.150 – $4.300 billion.
•Announced the appointment of Dr. Ted Love to the Board of Directors.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Net product sales increased 11% to $431.4 million in 3Q25 compared to 3Q24.
•Meaningful net patient adds in 3Q25 of approximately 450 patients. There were approximately 15,675 active patients exiting the quarter comprised of approximately 10,725 narcolepsy patients and approximately 4,950 idiopathic hypersomnia (IH) patients.

Epidiolex/Epidyolex (cannabidiol):
•Net product sales increased 20% to $302.6 million in 3Q25 compared to 3Q24.
•In 3Q25, volumes increased by 10%, driven by demand, and net product sales benefitted from lower gross to net deductions in the U.S.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Net product sales increased 1% to $99.9 million in 3Q25 compared to 3Q24.

Zepzelca (lurbinectedin):
•Net product sales decreased 8% to $79.3 million in 3Q25 compared to 3Q24.
•Zepzelca and atezolizumab combination was included in National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.

Ziihera (zanidatamab-hrii):
•Net product sales were $8.3 million in 3Q25 following product launch in December 2024.
•Updated the intent-to-treat population for the primary PFS (progression-free survival) and interim overall survival analyses of the HERIZON-GEA-01 trial to include the full patient population enrolled in the trial.

Modeyso (dordaviprone):
•Net product sales were $11.0 million in 3Q25 following product launch in August 2025.
•Modeyso was made commercially available quickly following FDA accelerated approval on August 6, ensuring patients with H3 K27M-mutant diffuse midline glioma (DMG) had access to the first and only targeted drug therapy for this ultra-rare and aggressive brain tumor.
•Modeyso was included in the NCCN Clinical Practice Guidelines in Oncology.

Corporate Development:
•The Company announced a global licensing agreement with Saniona to develop and commercialize SAN2355, a highly differentiated, subtype selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy and other potential indications.

Financial Highlights
Three Months Ended
September 30, Nine Months Ended
September 30,
(In thousands, except per share amounts) 2025 2024 2025 2024
Total revenues $ 1,126,107 $ 1,054,969 $ 3,069,660 $ 2,980,777
GAAP net income (loss) $ 251,412 $ 215,055 $ (559,599) $ 369,005
Non-GAAP adjusted net income1
$ 500,653 $ 412,359 $ 101,037 $ 951,445
GAAP earnings (loss) per share $ 4.08 $ 3.42 $ (9.18) $ 5.63
Non-GAAP adjusted earnings per share1
$ 8.13 $ 6.54 $ 1.63 $ 14.25

(Press release, Jazz Pharmaceuticals, NOV 5, 2025, View Source [SID1234659464])

Geron Corporation Reports Third Quarter 2025 Financial Results and Recent Business Highlights

On November 5, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the third quarter of 2025 and recent business highlights.

"The high unmet need in lower-risk MDS is well known, and RYTELO is a therapy with a novel mechanism of action and the potential to significantly impact the treatment paradigm. There is work ahead of us to fully maximize the value of this therapy and ensure RYTELO reaches more patients," said Harout Semerjian, President and Chief Executive Officer of Geron. "Geron is positioned, with our realigned leadership team, to strengthen commercial execution, increase both physician and patient awareness, and drive RYTELO sales in the U.S. We look forward to presenting meaningful data at ASH (Free ASH Whitepaper), enhancing our partnerships with the MDS community and conducting the interim analysis for the IMpactMF trial. Our actions are focused on creating value for our patients and shareholders."

Recent Business Highlights

RYTELO

Achieved net product revenue of $47.2 million in the third quarter of 2025.
Demand was down 3% quarter-over-quarter, with opportunities to elevate brand awareness and clinical value communications.
Number of ordering accounts is now approximately 1,150, an increase of approximately 150 quarter-over-quarter.
Increased RYTELO presence at major hematology forums, such as the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting.
Announced that two abstracts highlighting data from the IMerge clinical trial in lower-risk MDS were accepted for presentation at the ASH (Free ASH Whitepaper) 2025 Annual Meeting, including one oral presentation on the potential correlation between imetelstat clinical response rates and treatment-emergent cytopenias.
Clinical Pipeline

Completed enrollment of 320 patients in the IMpactMF Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis in September 2025.
Expect IMpactMF interim analysis readout for overall survival in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis in the second half of 2028 (when approximately 50% of patient events have occurred).
Announced three abstracts were accepted at the ASH (Free ASH Whitepaper) 2025 Annual Meeting highlighting clinical data from Geron’s IMbark and IMproveMF clinical trials and the investigator-sponsored IMpress clinical trial.
Corporate Updates

Announced the appointment of Ahmed ElNawawi ("Nawawi") as Executive Vice President, Chief Commercial Officer to advance the company’s strategic priorities, including driving growth, maximizing the potential of RYTELO, and strengthening the foundation for potential future portfolio expansion.
Appointed three additional executives with expertise across technical operations, investor relations and corporate affairs, and portfolio management, further strengthening the company’s commercial, operational and development capabilities.
Third Quarter 2025 Financial Results

Cash and Marketable Securities

As of September 30, 2025, Geron had approximately $421.5 million in cash, cash equivalents, restricted cash and marketable securities, compared to $502.9 million as of December 31, 2024.

Net Loss

For the three months ended September 30, 2025, the Company reported a net loss of $18.4 million, or $0.03 per share, compared to $26.4 million, or $0.04 per share, for the three months ended September 30, 2024.

Revenues

Total product revenue, net for the three months ended September 30, 2025, was $47.2 million, compared to $28.2 million for the three months ended September 30, 2024.

Total revenues for the three months ended September 30, 2025 was $47.2 million, compared to $28.3 million for the three months ended September 30, 2024. Total revenues include license fees and royalties in addition to product revenue, net.

Costs and Operating Expenses

Total costs and operating expenses for the three months ended September 30, 2025 were $61.1 million, compared to $56.5 million for the three months ended September 30, 2024.

Cost of goods sold was approximately $1.0 million for the three months ended September 30, 2025, compared to $456,000 for the three months ended September 30, 2024, which consisted of costs to manufacture and distribute RYTELO.

Research and development expenses for the three months ended September 30, 2025 were $21.1 million, compared to $20.2 million for the same period in 2024. The increase in research and development expenses for the three months ended September 30, 2025, compared to the same period in 2024, was primarily due to increased chemistry, manufacturing, and controls (CMC) and personnel-related expenses. Geron expects research and development expenses to increase in the remaining quarter of 2025 over 2024 levels, primarily due to ongoing investments to support the Company’s CMC strategy.

Selling, general and administrative expenses for the three months ended September 30, 2025 were $39.0 million, compared to $35.9 million for the same period in 2024. The increase in selling, general and administrative expenses was primarily due to an increase in sales and marketing full-time employees and additional investment in marketing programs.

2025 Financial Guidance

For fiscal year 2025, the Company expects total operating expenses will be between $250 million and $260 million, compared to previously announced guidance of approximately $270 million to $285 million. Total operating expenses include non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

Based on current operating plans and assumptions, the Company believes that its existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Wednesday, November 5, 2025, to discuss business updates and third quarter 2025 financial results.

A live webcast of the conference call and accompanying presentation will be available on the "Investors & Media" page of the Company’s website at www.geron.com. A replay of the webcast will be archived and available on the Company’s website.

(Press release, Geron, NOV 5, 2025, View Source [SID1234659463])

Genmab to Participate in a Fireside Chat at the Jefferies Global Healthcare Conference in London

On November 5, 2025 Genmab A/S (Nasdaq: GMAB) reported that its Chief Executive Officer Jan Van de Winkel and Chief Financial Officer Anthony Pagano will participate in a fireside chat at the Jefferies Global Healthcare Conference in London at 12:00 PM GMT (7:00 AM EST) on November 19, 2025. A webcast of the fireside chat will be available on Genmab’s website at View Source

(Press release, Genmab, NOV 5, 2025, View Source [SID1234659462])

Foghorn Therapeutics Provides Third Quarter 2025 Financial and Corporate Update

On November 5, 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 a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended September 30, 2025. The Company also announced that Chief Financial Officer, Kristian Humer, will be departing to pursue another opportunity.

"This quarter marked continued execution across our portfolio, reinforcing our leadership in developing novel precision therapies with broad applicability across cancers," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "FHD-909, in collaboration with Lilly, is advancing in a Phase 1 dose escalation trial for the treatment of SMARCA4-mutated cancers with a focus on NSCLC. Based on our preclinical monotherapy and combination data, we are enthusiastic about the development of FHD-909 with the goal of developing it as a front-line therapy in NSCLC. Our strategic collaboration with Lilly provides the necessary strategic and financial resources to develop FHD-909."

Mr. Gottschalk continued, "Momentum is strong for our wholly-owned, first-in-class selective degrader programs targeting CBP, EP300 and ARID1B with program updates highlighted during our recent virtual investor event. Our Selective CBP degrader, with potential in ER+ breast cancer, entered non-GLP toxicology studies in Q4 2025 and is advancing towards IND in 2026, and our Selective EP300 degrader continues to show broad spectrum efficacy across hematological malignancies and favorable tolerability in preclinical studies, differentiating it from dual CBP/EP300 approaches. Our Selective ARID1B degrader is progressing towards in vivo proof-of-concept in 2026 with potential in up to 5% of all solid tumors including endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer. Backed by our strong balance sheet and a cash runway into 2028, we are focused on delivering breakthrough therapies that harness the broad therapeutic potential of protein degradation and chromatin regulation. Finally, I want to thank Kristian for his leadership and commitment during his time at Foghorn. He has been a valued member of the team, and I wish him well in his future endeavors."

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely-related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors.
•Phase 1 trial enrolling well. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909, with NSCLC as the primary target population, is progressing well and the study remains on track.
•Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data demonstrates enhanced anti-tumor activity of FHD-909 in combination with standard-of-care (SoC) chemotherapies, anti-PD-1 pembrolizumab and several novel KRAS inhibitors in NSCLC animal models. The combination data will inform further development plans of FHD-909.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a U.S. 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs.

Selective CBP degrader program. Foghorn’s Selective CBP degrader selectively targets CBP, an acetyltransferase closely related to EP300 designed to target a synthetic relationship 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 between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. CBP lineage dependencies are also established in several cancers, including ER+ breast cancer.
•Selective CBP degrader program, IND-ready anticipated in 2026. In October 2025, preclinical data for Selective CBP degrader with potential in EP300-mutated cancers and in ER+ breast cancer was presented during a Foghorn virtual investor event which included:
•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
•Long Acting Injectable (LAI) formulation optimized for subcutaneous injection weekly or every other week for convenient administration
Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in multiple myeloma (MM) and diffuse large b-cell lymphoma (DLBCL).
•Selective EP300 Degrader program, with a focus in MM and DLBCL, IND-enabling studies expected in 2026. In October 2025 Foghorn presented efficacy and safety of Selective EP300 degraders in preclinical models of hematological malignancies which included:
•Broad anti-tumor activity in over 70% of all heme sub-lineages tested
•VHL based selective degrader shows impressive efficacy in MM without hematological toxicities including thrombocytopenia
•EP300 degraders show full efficacy in IMiD-resistant MM cell lines
•Tolerability profile with widespread potential for combinations
ARID1B degrader program. Foghorn’s Selective ARID1B degrader selectively targets and degrades ARID1B in ARID1A-mutated cancers. 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 several types of cancer, including endometrial, gastric, gastroesophageal junction, bladder and 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. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors.
•Selective ARID1B degrader program advancing towards in vivo proof of concept in 2026. In October 2025, data for Selective ARID1B degrader was presented at the TPD and Induced Proximity Summit and during a Foghorn virtual investor event which included:
•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

Degrader Platform. Foghorn continues to advance its degrader platform with investments in novel ligases, long-acting injectables, oral delivery, and induced proximity.

Corporate Update

Leadership. Chief Financial Officer, Kristian Humer, will be departing from the company, with his last day being November 14, 2025. A formal search for a successor has begun.

Third Quarter 2025 Financial Highlights

•Collaboration Revenue. Collaboration revenue was $8.2 million for the three months ended September 30, 2025, compared to $7.8 million for the three months ended September 30, 2024. The increase was driven by the continued advancement of programs under the Lilly Collaboration Agreement.

•Research and Development Expenses. Research and development expenses were $20.0 million for the three months ended September 30, 2025, compared to $24.7 million for the three months ended September 30, 2024. The decrease is attributed to a decrease in FHD-286 costs, decreases in personnel-related costs, early development and other research external costs and facilities and IT-related expenses, partially offset by an increase in Lilly-partnered programs.

•General and Administrative Expenses. General and administrative expenses were $6.7 million for the three months ended September 30, 2025, compared to $7.0 million for the three months ended September 30, 2024. This decrease was primarily due to lower facilities and IT related expenses.

•Net Loss. Net loss was $15.8 million for the three months ended September 30, 2025, compared to a net loss of $19.1 million for the three months ended September 30, 2024.

•Cash, Cash Equivalents, and Marketable Securities. As of September 30, 2025, the Company had $180.3 million in cash, cash equivalents, and marketable securities, providing cash runway into 2028.

About FHD-909
FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models.

(Press release, Foghorn Therapeutics, NOV 5, 2025, View Source [SID1234659461])

Bristol Myers Squibb Prices €5 Billion of Senior Unsecured Notes

On November 5, 2025 Bristol Myers Squibb (NYSE: BMY) reported that it has priced a public offering (the "Offering") of senior unsecured notes in a combined aggregate principal amount of €5 billion (collectively, the "Notes"). The Notes will be issued by Bristol Myers Squibb’s wholly-owned subsidiary, BMS Ireland Capital Funding Designated Activity Company, in five tranches: (i) €750,000,000 aggregate principal amount of 2.973% Notes due 2030, (ii) €1,150,000,000 aggregate principal amount of 3.363% Notes due 2033, (iii) €1,150,000,000 aggregate principal amount of 3.857% Notes due 2038, (iv) €750,000,000 aggregate principal amount of 4.289% Notes due 2045, and (v) €1,200,000,000 aggregate principal amount of 4.581% Notes due 2055. The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by Bristol-Myers Squibb Company. Bristol Myers Squibb expects that the closing of the Offering will occur on November 10, 2025, subject to the satisfaction of customary closing conditions.

On November 3, 2025, Bristol Myers Squibb commenced a tender offer (the "Tender Offer") to purchase, for cash, various series of its outstanding notes (the "Tender Offer Notes"). Bristol Myers Squibb intends to use the net proceeds of the Offering, together with approximately $3.0 billion of cash on hand, (i) to fund the Tender Offer and/or other repurchase, repayment or redemption of the notes subject to the Tender Offer, (ii) to pay fees and expenses in connection therewith and with the Offering and (iii) to the extent of any remaining proceeds, for general corporate purposes. The Offering is not contingent on the consummation of the Tender Offer or the purchase of any of the Tender Offer Notes in connection therewith.

Citigroup Global Markets Limited, Barclays Bank PLC, BNP PARIBAS, J.P. Morgan Securities plc and Société Générale are acting as joint lead managers and joint book-running managers for the Offering.

The Offering of the Notes is being made pursuant to an effective shelf registration statement (including a prospectus and preliminary prospectus supplement) (File Nos. 333-283810 and 333-283810-01) filed with the U.S. Securities and Exchange Commission (the "SEC"). You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Bristol Myers Squibb, any underwriter or any dealer participating in the Offering will arrange to send you the prospectus and the preliminary prospectus supplement (or, if available, the prospectus supplement) if you request it by contacting Bristol Myers Squibb Investor Relations or Citigroup Global Markets Limited at +1 800-831-9146, Barclays Bank PLC at +1 888-603-5847, BNP PARIBAS at +44 0-20-7595-8222, J.P. Morgan Securities plc (for non-U.S. investors) at +44-20 7134-2468 or J.P. Morgan Securities LLC (for U.S. investors) at (212) 834-4533 (call collect) and Société Générale at +1 855-881-2108.

(Press release, Bristol-Myers Squibb, NOV 5, 2025, View Source [SID1234659460])