UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

On May 7, 2025 UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC (Press release, UroGen Pharma, MAY 7, 2025, View Source [SID1234652658]).

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The ODAC meeting will provide an opportunity for independent clinicians and other experts to evaluate the UGN-102 data and make a recommendation to the FDA as to whether the NDA should be approved and under what conditions. The FDA carefully considers the advice of the Advisory Committee, but is not bound by its recommendations. The FDA has stated in its correspondence to the Company that they intend to complete their review in time to meet the Prescription Drug User Fee Act (PDUFA) target action date of June 13, 2025.

"We are excited to discuss our data with the Advisory Committee and broader medical community as we continue our mission to bring innovative solutions to patients suffering from bladder cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "We believe UGN-102 represents a meaningful advancement for patients facing the recurrent and challenging nature of LG-IR-NMIBC, and we look forward to the opportunity to discuss its potential."

UGN-102 is in development as a therapeutic option for patients with recurrent LG-IR-NMIBC, a condition for which there are no FDA-approved drugs. The NDA is supported by results from the pivotal Phase 3 ENVISION trial which demonstrated a 79.6% complete response (CR) rate at 3 months after first instillation of UGN-102, and duration of response of 82.5% at 12 months after 3-month CR by Kaplan-Meier analysis.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102, scheduled an ODAC meeting for May 21, 2025, and assigned a PDUFA target action date of June 13, 2025.

About Low-Grade Non-Muscle Invasive Bladder Cancer (NMIBC)

In the U.S., bladder cancer is the second most common urologic cancer in men and primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. More specifically, LG-IR-NMIBC represents approximately 23,000 newly diagnosed bladder cancer patients each year and an estimated 59,000 recurrences annually among patients diagnosed in previous years. Guideline recommendations for the management of NMIBC include trans-urethral resection of bladder tumor (TURBT) as the standard of care. Up to 70% of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures.

IN8bio Reports First Quarter 2025 Financial Results and Recent Business Highlights

On May 7, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported financial results and business highlights for the first quarter ended March 31, 2025 and recent corporate highlights (Press release, In8bio, MAY 7, 2025, View Source [SID1234652657]).

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"IN8bio stands at the forefront of gamma-delta T cell innovation, pioneering transformative therapies for cancer patients with urgent unmet needs. Driven by our commitment to scientific excellence, we are advancing our mission of Cancer ZeroTM with elegant, cutting-edge approaches. Our clinical data showcases robust activity, delivering extended progression-free survival and a unique safety profile across challenging cancers to date. As the biopharmaceutical industry excitedly embraces novel T cell engagers, IN8bio is once again redefining the landscape with our innovative INB-600 TCE platform. The preclinical data unveiled at AACR (Free AACR Whitepaper) represents a leap forward," said William Ho, CEO & co-founder, IN8bio. "Harnessing our deep expertise, we’ve engineered a breakthrough technology that achieves picomolar potency, enhances immune surveillance, and potentially mitigates some of the safety risks associated with conventional CD3-targeted TCEs. We’re excited to advance this platform into both oncology and autoimmune indications and continue building a differentiated pipeline that promises to reshape the future of medicine."

Corporate Highlights and Recent Developments
Expanded Pipeline with INB-600 Gamma-Delta T Cell Engager Platform

Presented new preclinical data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting the INB-600 platform, including lead candidates INB-619 (targeting CD19) and INB-633 (targeting CD33).
Preclinical studies demonstrated strong, antigen-specific cytotoxicity against leukemia cells and primary B cells with minimal inflammatory cytokine release, potentially addressing key limitations of conventional CD3-based TCEs.
INB-600 TCE platform significantly expands both Vδ1+ and Vδ2+ subsets to address the reduced cell counts that have limited earlier γδ TCE therapies in cancer patients.
Targeted B cell elimination (INB-619) highlights potential applications in B cell–driven autoimmune diseases as well as oncology indications.
Demonstrated Additional Clinical Progress Across Gamma-Delta T Cell Therapy Pipeline

Presented Positive Phase 1 data (February 2025) for INB-100 (Allogeneic Gamma-Delta T Cell Therapy for High-Risk AML and Leukemias) at the 2025 Transplantation & Cellular Therapy (TCT) Annual Meeting showing durable remissions, with 100% of treated AML patients remaining relapse-free with 20.1 month median follow-up as of January 17, 2025.
Observed a favorable safety profile, with no cases of cytokine release syndrome (CRS) or neurotoxicity (ICANs) reported to date.
1-Year Survival Rates Exceeded Real-World Control Groups: The 1-year progression-free survival (PFS) rate across all leukemia patients is 90.9% and 1-year overall survival (OS) is 100%, outperforming comparative real-world historical control data obtained from both the Center for International Blood & Marrow Transplant Research (CIBMTR) and from the University of Kansas Cancer Center.
Participation at Immuno-Oncology 360° (IO360°) Conference

William Ho, Chief Executive Officer and co-founder of IN8bio, Co-Chaired Day 2 of the Immuno-Oncology 360° (IO360°) Conference on March 25, 2025, delivering opening remarks, leading the "State of the IO Market, Investments and Deals Plenary" session, and presenting on the promise of gamma-delta T cell engagers for oncology and autoimmune diseases, including INB-619.
Upcoming Anticipated Pipeline Milestones and Events

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting (May 30, 2025):

Upcoming oral presentation: "INB-200: Phase 1 Study of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ)" will present updated clinical data from IN8bio’s Phase 1 trial of INB-200. The data will be featured in the Central Nervous System Tumors Oral Abstract Session.

International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting (May 9, 2025):

Upcoming oral presentation: "From Donor to Therapy: How Robust Manufacturing Shapes the TCR Repertoire and Cytotoxic Power of Donor-Derived Allogeneic ex vivo Expanded and Activated γδ T Cell Products" will highlight the power of the company’s gamma-delta T cell manufacturing platform. The data will demonstrate the TCR diversity, genomic profiling and cytotoxic function of donor-derived clinical gamma-delta T cell therapies. Mariska ter Haak, Senior Director, Analytical Development at IN8bio, will present during the Oral Abstract Session – Immunotherapy.

Poster Presentation: "Selection and Implementation of the Electronic Quality Management System for High Complexity Clinical Stage Cellular Therapy Company." This will be presented by Guoling Chen, Senior Director, Quality Operations.

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2025 Annual Meeting (May 17, 2025):

Upcoming oral presentation: "Decoding the Molecular Signature of Expanded Gamma Delta T Cell Products; TCR and Immune Gene Expression from Allogeneic Derived Products" will present new data characterizing the TCR repertoire and immune gene expression profiles of IN8bio’s clinical expanded gamma-delta T cell products. This data will show the robustness and reproducibility of the in-house developed manufacturing platform at IN8bio. Mariska ter Haak, Senior Director, Analytical Development, will deliver the presentation at the New Orleans Ernest N. Morial Convention Center.

Poster Presentation: "INB-600: A Novel T Cell Engager Platform Specific for gamma-delta (γδ) T cells" will demonstrate the use of the novel CD19 γδ TCE for driving deep B cell depletion and potential application in autoimmune disease including Lupus. This will be presented by Lawrence Lamb, Ph.D., Co-Founder and Chief Scientific Officer.

First Quarter 2025 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $3.0 million for the three months ended March 31, 2025, compared with $4.9 million in the prior year. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation. The change was primarily due to decreased but some remaining clinical trial-related activities for the INB-400 program and a decrease in personnel-related costs, in each case as a result of the Company’s pipeline prioritization announced in September 2024.
General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended March 31, 2025, compared with $3.7 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services.
Net loss: The company reported a net loss of $5.6 million, or $0.07 per basic and diluted common share, for the three months ended March 31, 2025, compared with a net loss of $8.6 million, or $0.20 per basic and diluted common share, for the comparable prior year period.
Cash position: As of March 31, 2025, the Company had cash of $11.9 million, compared with $13.0 million for the comparable prior year. Subsequently, in April 2025, the Company received aggregate gross proceeds of $1.9 million from the exercise of its Series A and Series B common stock warrants.

Xencor Reports First Quarter 2025 Financial Results

On May 7, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2025 and provided a review of recent business and program updates (Press release, Xencor, MAY 7, 2025, View Source [SID1234652654]).

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"Recently presented interim Phase 1 results support XmAb942 as a high potency investigational anti-TL1A antibody and an every 12-week subcutaneous dosing regimen during the maintenance treatment period, which is a more convenient regimen for patients when compared to first-generation anti-TL1A antibodies. We are on track to initiate the Phase 2b XENITH-UC study of XmAb942 in ulcerative colitis later this year. We also expect to advance an XmAb TL1A x IL23p19 bispecific antibody candidate into Phase 1 in 2026," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Throughout 2025, we will continue to have a number of updates across our oncology and autoimmune pipelines."

Additionally, Nancy Valente, M.D., is retiring from her role as chief development officer (CDO) and transitioning to a senior advisor role in June 2025. Following her career in biopharmaceutical product development at Genentech, Dr. Valente was appointed to Xencor’s Board of Directors in September 2022 and then joined the management team as CDO in May 2023 to advance the Company’s clinical development strategy and organization and to lead the long-term positioning of its oncology programs. The Company’s senior leaders for oncology and autoimmune clinical development will continue in their roles and report to the CEO.

"I would like to thank Nancy on behalf of the entire company for her many contributions to Xencor as a Board member and CDO. She has reshaped our clinical strategy for our oncology programs and recruited a strong team to lead the work. We are delighted she will remain active as a senior advisor and will continue to help guide us," said Dr. Dahiyat.

Recent Program Updates

XmAb942 (Xtend TL1A): XmAb942 is a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD). The first generation of anti-TL1A antibodies have reduced disease activity in patients with UC and CD in multiple clinical studies, demonstrating the potential of this new drug class. Interim Phase 1 results for XmAb942 from a dose-escalation study in healthy volunteers were announced in April 2025. The results showed that XmAb942 was well tolerated at single and multiple doses. Pharmacokinetic analysis of the single dose cohorts estimated a human half-life of greater than 71 days, which supports a 12-week dosing interval during maintenance treatment. Xencor expects to start the XENITH-UC Study, a Phase 2b study of XmAb942 in UC, in the second half of 2025. XENITH-UC will be a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy.

XmAb TL1A x IL23p19: Xencor is conducting lead selection studies and has begun good manufacturing practice (GMP) production campaigns for a TL1A x IL-23p19 bispecific antibody, that is designed to target two important inflammatory pathways for autoimmune and inflammatory disease while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. In vitro studies show that several lead candidates match the target inhibition potency of monospecific antibodies to these targets, in a simple IgG bispecific format. Xencor anticipates initiating first-in-human studies during 2026.
Recent Partnership Developments

Incyte Corporation: In December 2024, Incyte announced positive full results from the pivotal study of tafasitamab in combination with lenalidomide and rituximab in relapsed or refractory follicular lymphoma and submitted a supplemental Biologics License Application, which was accepted for review by the U.S. Food and Drug Administration in February 2025. Xencor earned a $12.5 million regulatory milestone payment in addition to non-cash royalty revenue from sales of Monjuvi/Minjuvi for the first quarter of 2025. Monjuvi and Minjuvi are registered trademarks of Incyte.

Vir Biotechnology, Inc.: Vir is developing tobevibart, a neutralizing antibody that uses XmAb Fc technologies, for the treatment of patients with chronic hepatitis delta (CHD) and patients with chronic hepatitis B. In March 2025, Vir initiated a Phase 3 study of tobevibart in combination for people living with CHD. We earned a $2.0 million development milestone payment from Vir for the first quarter of 2025.
Additional Corporate Updates

In March, Xencor appointed Todd Simpson to its board of directors. Mr. Simpson is an accomplished finance and operations executive with broad experience in corporate strategy. He has more than 40 years of experience in chief financial officer (CFO) roles at multiple biopharmaceutical companies and in public accounting, and most recently he served as CFO at Seagen through its acquisition by Pfizer in 2023.
Financial Guidance: Based on current operating plans, Xencor expects to end 2025 with between $535 million and $585 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2028.

Financial Results for the First Quarter Ended March 31, 2025

Cash, cash equivalents and marketable debt securities totaled $693.5 million as of March 31, 2025, compared to $706.7 million as of December 31, 2024.

Revenue for the first quarter ended March 31, 2025 was $32.7 million, compared to $16.0 million for the same period in 2024. Revenue earned in the first quarter of 2025 was primarily non-cash royalty revenue from Alexion and Incyte and milestone revenue from Incyte and Vir, compared to the same period in 2024, which was primarily non-cash royalty revenue from Alexion and Incyte.

Research and development (R&D) expenses for the first quarter ended March 31, 2025 were $58.6 million, compared to $56.9 million for the same period in 2024. Increased R&D spending for the first quarter of 2025 compared to 2024 is primarily due to increased spending on XmAb819 (ENPP3 x CD3), XmAb541 (CLDN6 x CD3) and XmAb657 (CD19 x CD3), partially offset by reduced wind-down costs on terminated programs.

General and administrative (G&A) expenses for the first quarter ended March 31, 2025 were $17.3 million, compared to $13.8 million for the same period in 2024. Increased G&A spending for the first quarter of 2025 compared to 2024 is primarily due to increased spending on professional fees.

Other expense, net, for the first quarter ended March 31, 2025 was $5.1 million, compared to $19.5 million for the same period in 2024. Decreased other expense, net, for the first quarter of 2025, compared to 2024, is primarily due to lower asset impairment charges.

Net loss attributable to Xencor for the first quarter ended March 31, 2025 was $48.4 million, or $(0.66) on a fully diluted per share basis, compared to net loss of $73.4 million, or $(1.20) on a fully diluted per share basis, for the same period in 2024.

Upcoming Investor Conferences

Company management will participate at multiple upcoming investor conferences:

BofA Securities Health Care Conference
Date: Tuesday, May 13, 2025
Presentation Time: 6:40 p.m. ET / 3:40 p.m. PT

RBC Capital Markets Global Healthcare Conference
Date: Tuesday, May 20, 2025
Presentation Time: 9:00 a.m. ET / 6:00 a.m. PT
Live webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Replays of the events will be available on the Xencor website for at least 30 days following the presentations.

Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved

On May 7, 2025 Teva reported Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved (Press release, Teva, MAY 7, 2025, View Source [SID1234652652]).

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On track for 30% operating profit margin by 2027 in line with our Pivot to Growth Strategy; Q1 2025 shows ninth consecutive quarter of revenue growth, excluding revenues recorded for Sanofi collaboration.
Q1 2025 revenues of $3.9 billion, an increase of 5%; net of $100 million foreign exchange impact, reported revenues growth of 2%.
AUSTEDO – shows continued strong growth, with worldwide revenues of $411 million in Q1 2025, an increase of 39% in local currency terms compared to Q1 2024; increasing 2025 full-year revenue outlook from ~$1.9-2.05 billion to $1.95-2.05 billion.
AJOVY – global revenues of $139 million in Q1 2025, an increase of 26% in local currency terms compared to Q1 2024. Reaffirming $600M 2025 revenue outlook.
UZEDY continues strong momentum – global revenues of $39 million in Q1 2025.
The generics business grew across all regions – increased by 5% in the U.S., 1% in Europe and 2% in International Markets, all in local currency terms, as compared to Q1 2024.
Duvakitug (Anti-TL1A) Phase 3 ready; program initiation expected in H2 2025; preparing for olanzapine LAI FDA NDA submission in H2 2025.
Transforming Teva: Targeted programs to deliver~$700 million of net savings, after incremental reinvestment behind growth, to transform Teva into a modern biopharmaceutical company and achieving 30% operating margin target in 2027.
Current, confirmed U.S. tariffs expected to have immaterial impact; absorbed in updated 2025 non-GAAP outlook.
Teva to host Innovation & Strategy Day on Thursday, May 29 in New York, NY.
Q1 2025 Highlights:

Revenues of $3.9 billion
GAAP diluted EPSof $0.18
Non-GAAP diluted EPS of $0.52, an increase of $0.04 or 8% year-over-year
Cash flow used in operating activities of $105 million
Free cash flow of $107 million
Underlying full-year outlook increased, excluding the impact of the Japan BV divestiture which closed on March 31, 2025 full year 2025 business outlook(1)(2)revised:
Revenues of $16.8 ‐ $17.2 billion (-$200 million impact from at the high-end)
Non‐GAAP operating income of $4.3‐$4.6 billion (+$200 million at the low-end; mid-point increased by $100 million)
Adjusted EBITDA of $4.7 ‐ $5.0 billion(+$200 million at the low-end; same as above)
Non‐GAAP diluted EPS of $2.45 ‐ $2.65 (+$0.10 at the low-end, mid-point increased by $0.10)
Free cash flow of $1.6 ‐ $1.9 billion (unchanged)
(1) Revised 2025 outlook now includes no contribution from the Japan BV after Q1 and continues to include a full year contribution from Teva API, as well as exclude the expected income from development milestone payments from Sanofi in connection with the Phase 3 ulcerative colitis and Crohn’s Disease initiations for duvakitug.

(2) This outlook is based on the existing tariff and trade environment as of May 7, 2025, and does not reflect any policy shifts, including pharmaceutical sector tariffs, that could impact business.

TEL AVIV, May 07, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended March 31, 2025.

Mr. Richard Francis, Teva’s President and CEO, said, "Teva had a solid start to the year, with its ninth consecutive quarter of revenue growth, delivering global revenues of $3.9 billion, an increase of 5% in local currency terms compared to the first quarter of 2024. Our key innovative growth drivers continue to show strong momentum, collectively generating revenues of $589 million while each growing more than 25% year over year. We also achieved solid generics performance across all regions with biosimilars rounding out the portfolio."

Mr. Francis continued, "Now entering the Acceleration Phase of our Pivot to Growth Strategy, we have a clear roadmap to continue Teva’s transformation into a leading biopharmaceutical company with an expected 30% operating margin and today have announced ~$700 million net savings by 2027. We’re accelerating innovative growth and strengthening our generics business, while streamlining our operations, sharpening our business and optimizing processes. With these results, we are revising our 2025 outlook and reaffirming our 2027 targets."

Pivot to Growth Strategy

In Q1 2025, we continued to execute on the four key pillars of our Pivot to Growth strategy, which we announced in May 2023.

Delivering on our Growth Engines – on the first pillar, we continued to demonstrate strong performance of our key innovative products – AUSTEDO, AJOVY, and UZEDY. Collectively, these products grew ~39% year-over-year in the first quarter. This growth is driven by the strength of their product profiles, continued investments to promote awareness and access, and focused execution by our sales and marketing teams globally.
Stepping Up Innovation – on the second pillar, we accelerated the development of certain key pipeline assets, including the recent positive Phase 2b results for duvakitug (anti-TL1A) in Crohn’s Disease and ulcerative colitis. We anticipate upcoming milestones for olanzapine LAI (NDA filing in 2025) and for DARI (Dual-action Asthma Rescue Inhaler; Phase 3 full enrollment in 2025 and potential Phase 3 event-driven read-out in 2026), as well the announcement of the start of the Phase 3 IBD programs for duvakitug in H2 2025.
Sustaining Our Generics Powerhouse – under the third pillar, we remained focused on strengthening our position as a global leader in generic medicines with a streamlined portfolio, robust pipeline, integrated manufacturing and global commercial footprint. In the past few quarters, we achieved several successful launches of biosimilars and other high-value complex generics including liraglutide, octreotide, SIMLANDI (adalimumab-ryvk), SELARSDITM (ustekinumab-aekn) and Epysqli (eculizumab-aagh).
Focusing our Business – Lastly, on our fourth pillar, to accelerate our growth we are actively transforming our business through portfolio and global manufacturing footprint optimization. Our ongoing efforts to allocate capital appropriately include debt repayment of $1.4 billion at maturity, our recently completed divestment of our business venture in Japan, our intention to divest our API business through a sale, and ongoing programs to improve working capital efficiency.
Teva is moving into the second phase of our Pivot to Growth strategy – Acceleration. We will focus on growing our innovative portfolio, modernizing and simplifying our organization and operations, reinforcing our commitment to patents, and aligning capital allocation to invest in the highest value activities.
Teva continues in its effort to sell its active-pharmaceutical ingredient (API) business and is engaged with prospective purchasers. The timing and structure of the planned transaction are subject to ongoing consideration and the consummation of the sale remains contingent on reaching a definitive agreement, subject to approval by Teva’s Board of Directors. On December 31, 2024, Teva classified its API business (including its R&D, manufacturing and commercial activities) as held for sale.
First Quarter 2025 Consolidated Results

Revenues in the first quarter of 2025 were $3,891 million, an increase of 2% in U.S. dollars or 5% in local currency terms, compared to the first quarter of 2024. This increase was mainly due to higher revenues from AUSTEDO in our United States segment, from generic products in all our segments, from AJOVY in all our segments, as well as from UZEDY in our U.S. segment, partially offset by lower revenues from the sale of mature innovative product rights in 2024. Exchange rate movements during the first quarter of 2025, including hedging effects, negatively impacted revenues by $101 million, compared to the first quarter of 2024.

Exchange rate movements during the first quarter of 2025, including hedging effects, negatively impacted our operating income by $50 million and non-GAAP operating income by $51 million compared to the first quarter of 2024.

Gross profit in the first quarter of 2025 was $1,877 million, an increase of 6% compared to $1,771 million in the first quarter of 2024. Gross profit margin was 48.2% in the first quarter of 2025, compared to 46.4% in the first quarter of 2024. Non-GAAP gross profit was $2,054 million in the first quarter of 2025, an increase of 5% compared to $1,963 million in the first quarter of 2024. Non-GAAP gross profit margin was 52.8% in the first quarter of 2025, compared to 51.4% in the first quarter of 2024. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to a favorable mix of products, primarily driven by higher revenues from AUSTEDO, partially offset by a negative impact from foreign exchange rate movements including hedging effects.

Research and Development (R&D) expenses, net in the first quarter of 2025 were $247 million, an increase of 2% compared to $242 million in the first quarter of 2024. Our higher R&D expenses, net in the first quarter of 2025 compared to the first quarter of 2024, were mainly due to an increase in immunology and in immuno-oncology projects, as well as in our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), partially offset by the non-recurrence of milestone payments related to certain biosimilar projects in the first quarter of 2025.

Selling and Marketing (S&M) expenses in the first quarter of 2025 were $622 million, an increase of 2% compared to the first quarter of 2024. This increase was mainly to support revenue growth.

General and Administrative (G&A) expenses in the first quarter of 2025 were $297 million, an increase of 7% compared to the first quarter of 2024.

Other loss in the first quarter of 2025 was $5 million, compared to $1 million in the first quarter of 2024.

Operating Income in the first quarter of 2025 was $519 million, compared to an operating loss of $218 million in the first quarter of 2024. Operating income as a percentage of revenues was 13.3% in the first quarter of 2025, compared to an operating loss as a percentage of revenues of 5.7% in the first quarter of 2024. This increase was mainly due to other asset impairments, restructuring and other items in the first quarter of 2024 as well as higher gross profit in the first quarter of 2025. Non-GAAP operating income in the first quarter of 2025 was $946 million representing a non-GAAP operating margin of 24.3% compared to non-GAAP operating income of $892 million representing a non-GAAP operating margin of 23.4% in the first quarter of 2024. The increase in non-GAAP operating margin in the first quarter of 2025 was due to higher gross profit margin, partially offset by an increase of operating expenses as a percentage of revenues.

Financial expenses, net in the first quarter of 2025, were $225 million, mainly comprised of net-interest expenses of $212 million. In the first quarter of 2024, financial expenses, net were $250 million, mainly comprised of net-interest expenses of $233 million.

In the first quarter of 2025, we recognized a tax expense of $74 million, on a pre-tax income of $294 million. In the first quarter of 2024, we recognized a tax benefit of $52 million, on a pre-tax loss of $467 million.

Non-GAAP tax rate in the first quarter of 2025 was 17.5%, compared to 15.0% in the first quarter of 2024. Our non-GAAP tax rate in the first quarter of 2025 was mainly affected by the generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate as well as infrequent or non-recurring items. Our non-GAAP tax rate in the first quarter of 2024 was mainly affected by deferred tax benefits resulting from IP-related integration plans, the generation of profits in various jurisdictions with different tax rates, tax benefits in Israel and other countries, as well as infrequent or non-recurring items.

We expect our annual non-GAAP tax rate for 2025 to be between 15%-18%, slightly higher than our non-GAAP tax rate for 2024, which was 15.3%, mainly due to net tax benefit related to deferred tax assets resulting from intellectual property-related integration plans in 2024.

Net income attributable to Teva and diluted earnings per share in the first quarter of 2025 were $214 million and $0.18, respectively, compared to net loss attributable to Teva and loss per share of $139 million and $0.12, respectively, in the first quarter of 2024. This change was mainly due to higher operating income in the first quarter of 2025, partially offset by higher net loss attributable to redeemable and non-redeemable non-controlling interests in the first quarter of 2024 as well as higher income taxes in the first quarter of 2025, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the first quarter of 2025 were $602 million and $0.52, respectively, compared to $548 million and $0.48, respectively, in the first quarter of 2024.

Adjusted EBITDA was $1,041 million in the first quarter of 2025, an increase of 4%, compared to $1,005 million in the first quarter of 2024.

As of March 31, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,178 million shares and 1,167 million shares, respectively.

Non-GAAP information: net non-GAAP adjustments in the first quarter of 2025 were $388 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the first quarter of 2025 were adjusted to exclude the following items:

Amortization of purchased intangible assets of $145 million, of which $135 million is included in cost of sales and the remaining $10 million in S&M expenses;
Impairment of long-lived assets in the amount of $77 million;
Legal settlements and loss contingencies of $83 million;
Contingent consideration expenses of $11 million;
Equity compensation expenses of $34 million;
Restructuring expenses of $14 million;
Financial expenses of $14 million;
Other non-GAAP items of $63 million;
Items attributable to redeemable non-controlling interests of $2 million; and
Corresponding tax effects and unusual tax items of $55 million;
We believe that excluding such items facilitates investors’ understanding of our business including underlying performance trends, thereby improving the comparability of our business performance results between reporting periods.

For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow used in operating activities during the first quarter of 2025 was $105 million, compared to $124 million of cash flow used in operating activities in the first quarter of 2024. The lower cash flow used in operating activities in the first quarter of 2025 resulted mainly from higher profit in our U.S. segment, partially offset by higher tax payments. Net changes in working capital items were neutral.

During the first quarter of 2025, we generated free cash flow of $107 million, which we define as comprising $105 million in cash flow used in operating activities, $322 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $17 million proceeds from divestitures of businesses and other assets, partially offset by $127 million in cash used for capital investment. During the first quarter of 2024, we generated free cash flow of $32 million, which we define as comprising $124 million in cash flow used in operating activities, $295 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program), partially offset by $124 million in cash used for capital investment and $15 million in cash used for acquisition of businesses, net of cash acquired. The increase in 2025 resulted mainly from higher proceeds from divestitures of businesses and other assets and lower cash used for acquisition of businesses, net of cash acquired, as well as from lower cash flow used in operating activities.

As of March 31, 2025, our debt was $16,651 million, compared to $17,783 million as of December 31, 2024. This decrease was mainly due to repayment at maturity of $1,368 million of our senior notes, partially offset by $233 million of exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2025 was 3% compared to 10% as of December 31, 2024.

Our average debt maturity was approximately 5.7 years as of March 31, 2025, compared to 5.5 years as of December 31, 2024.

Segment Results for the First Quarter of 2025

United States Segment

The following table presents revenues, expenses and profit for our United States segment for the three months ended March 31, 2025 and 2024:

Three months ended March 31,

2025

2024

(U.S. $ in millions / % of Segment Revenues)

Revenues

$

1,910

100%

$

1,725

100%

Cost of sales

851

44.6%

867

50.2%

Gross profit

1,058

55.4%

858

49.8%

R&D expenses

154

8.1%

154

8.9%

S&M expenses

273

14.3%

261

15.1%

G&A expenses

96

5.0%

93

5.4%

Other

3

§

1

§

Segment profit*

$

532

27.9%

$

350

20.3%

* Segment profit does not include amortization and certain other items.
§ Represents an amount less than 0.5%.

Revenues from our United States segment in the first quarter of 2025 were $1,910 million, an increase of $184 million, or 11%, compared to the first quarter of 2024. This increase was mainly due to higher revenues from our innovative products, mainly AUSTEDO and UZEDY, as well as higher revenues from generic products.

Revenues by Major Products and Activities

The following table presents revenues for our United States segment by major products and activities for the three months ended March 31, 2025 and 2024:



Three months ended
March 31,


Percentage
Change


2025


2024


2025-2024


(U.S. $ in millions)



Generic products (including biosimilars)


$

849


$

808


5%

AJOVY


53


45


18%

AUSTEDO


396


282


40%

BENDEKA and TREANDA


36


46


(20%)

COPAXONE


54


30


79%

UZEDY


39


15


156%

Anda


373


381


(2%)

Other


109


117


(7%)

Total


$

1,910


$

1,725


11%


Generic products (including biosimilars) revenues in our United States segment in the first quarter of 2025 were $849 million, an increase of 5% compared to the first quarter of 2024. This increase was mainly driven by higher revenues from lenalidomide capsules (the generic version of Revlimid) and the launch of SIMLANDI (adalimumab-ryvk) injection (the biosimilar to Humira).

Among the most significant generic products we sold in the United States in the first quarter of 2025 were lenalidomide capsules (the generic version of Revlimid), Truxima (the biosimilar to Rituxan) and epinephrine injectable solution (the generic equivalent of EpiPen and EpiPen Jr). In the first quarter of 2025, our total prescriptions were approximately 273 million (based on trailing twelve months), representing 7.1% of total U.S. generic prescriptions, compared to approximately 314 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions in the first quarter of 2024, all according to IQVIA data.

On February 21, 2025, Teva launched SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older. On May 5, 2025, Teva and Alvotech announced that the FDA has approved SELARSDI (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025.

AJOVY revenues in our United States segment in the first quarter of 2025 were $53 million, an increase of 18% compared to the first quarter of 2024, mainly due to growth in volume. In the first quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 30.2% compared to 27.4% in the first quarter of 2024.

AUSTEDO revenues in our United States segment in the first quarter of 2025 increased by 40%, to $396 million, compared to $282 million in the first quarter of 2024. This increase was mainly due to growth in volume, including the approval of AUSTEDO XR one pill, once-daily treatment in May 2024.

AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in 18 mg in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, which is additional to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.

On January 17, 2025, the Centers for Medicare and Medicaid Services ("CMS") released a list of prescription medicines selected for price-setting discussions, which included AUSTEDO and AUSTEDO XR. The price-setting process has commenced, and the revised prices set by the government, which will apply to eligible Medicare patients, are expected to become effective on January 1, 2027. As the price-setting process is still in its early stages, the extent to which prices for AUSTEDO and AUSTEDO XR will change as a result of such discussions remains uncertain.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the first quarter of 2025 were $39 million, an increase of 156% compared to the first quarter of 2024, mainly due to growth in volume. UZEDY (risperidone) extended-release injectable suspension was approved by the FDA on April 28, 2023 for the treatment of schizophrenia in adults, and was launched in the U.S. in May 2023. UZEDY is a subcutaneous, long-acting formulation of risperidone that controls the steady release of risperidone. UZEDY is protected by four Orange Book patents expiring between 2027 and 2040. UZEDY is protected by regulatory exclusivity until April 28, 2026. We are moving forward with plans to launch UZEDY in other countries around the world. UZEDY faces competition from multiple other products.

BENDEKA and TREANDA combined revenues in our United States segment in the first quarter of 2025 were $36 million, a decrease of 20% compared to the first quarter of 2024, mainly due to competition from alternative therapies, as well as the entry of generic bendamustine products into the market. The orphan drug exclusivity that had attached to bendamustine products expired in December 2022.

COPAXONE revenues in our United States segment in the first quarter of 2025 were $54 million, an increase of 79% compared to the first quarter of 2024, mainly due to reduction in sales allowance, partially offset by market share erosion and competition.

Anda revenues from third-party products in our United States segment in the first quarter of 2025 were $373 million, a decrease of 2%, compared to $381 million in the first quarter of 2024. This decrease was mainly due to lower volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.

United States Gross Profit

Gross profit from our United States segment in the first quarter of 2025 was $1,058 million, an increase of 23%, compared to $858 million in the first quarter of 2024.

Gross profit margin for our United States segment in the first quarter of 2025 increased to 55.4%, compared to 49.8% in the first quarter of 2024. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from AUSTEDO.

United States Profit

Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items. Profit from our United States segment in the first quarter of 2025 was $532 million, an increase of 52% compared to $350 million in the first quarter of 2024. This increase was mainly due to higher gross profit, as discussed above.

Europe Segment

Our Europe segment includes the European Union, the United Kingdom and certain other European countries.

The following table presents revenues, expenses and profit for our Europe segment for the three months ended March 31, 2025 and 2024:


Three months ended March 31,


2025


2024


(U.S. $ in millions / % of Segment Revenues)

Revenues

$

1,194

100%

$

1,272

100%

Cost of sales


536

44.9%


534

42.0%

Gross profit


658

55.1%


738

58.0%

R&D expenses


60

5.1%


56

4.4%

S&M expenses


199

16.7%


194

15.2%

G&A expenses


69

5.8%


65

5.1%

Other


§

§


1

§

Segment profit*

$

329

27.6%

$

423

33.2%

* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our Europe segment in the first quarter of 2025 were $1,194 million, a decrease of 6%, or $78 million, compared to the first quarter of 2024. In local currency terms, revenues decreased by 2% compared to the first quarter of 2024, mainly due to lower revenues from COPAXONE and from the sale of mature innovative product rights in 2024, partially offset by higher revenues from AJOVY.

In the first quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $55 million, including hedging effects, compared to the first quarter of 2024. Revenues in the first quarter of 2025, included $12 million from a negative hedging impact, which is included in "Other" in the table below. Revenues in the first quarter of 2024 included $8 million from a positive hedging impact, which is included in "Other" in the table below.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended March 31, 2025 and 2024:


Three months ended
March 31,


Percentage
Change


2025


2024


2025-2024


(U.S. $ in millions)


Generic products (including OTC and biosimilars)


$

989


$

1,004


(1%)

AJOVY


58


51


14%

COPAXONE


42


57


(27%)

Respiratory products


55


66


(18%)

Other


50


94


(46%)

Total


$

1,194


$

1,272


(6%)


Generic products revenues (including OTC and biosimilar products) in our Europe segment in the first quarter of 2025, were $989 million, a decrease of 1% compared to the first quarter of 2024. In local currency terms, revenues increased by 1%, mainly due to higher volumes and price increases as a result of market conditions such as inflationary pressures in certain markets, as well as revenues from recently launched products.

AJOVY revenues in our Europe segment in the first quarter of 2025 increased by 14% to $58 million, compared to $51 million in the first quarter of 2024. In local currency terms revenues increased by 18% due to growth in volume.

COPAXONE revenues in our Europe segment in the first quarter of 2025 were $42 million, a decrease of 27% compared to the first quarter of 2024. In local currency terms revenues decreased by 24%, due to price reductions and a decline in volume resulting from the availability of alternative therapies and competing glatiramer acetate products.

In certain countries, Teva remains in litigation against generic companies regarding COPAXONE.

Respiratory products revenues in our Europe segment in the first quarter of 2025 were $55 million, a decrease of 18% compared to the first quarter of 2024. In local currency terms, revenues decreased by 16%, mainly due to net price reductions and lower volumes.

Europe Gross Profit

Gross profit from our Europe segment in the first quarter of 2025 was $658 million, a decrease of 11% compared to $738 million in the first quarter of 2024.

Gross profit margin for our Europe segment in the first quarter of 2025 decreased to 55.1%, compared to 58.0% in the first quarter of 2024. This decrease was mainly due to a negative impact from hedging activities and unfavorable mix of products.

Europe Profit

Profit of our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the first quarter of 2025 was $329 million, a decrease of 22%, compared to $423 million in the first quarter of 2024. This decrease was mainly due to lower gross profit, as discussed above.

International Markets Segment

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries.

The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, branded generics-oriented markets, such as Russia and certain Latin America markets and hybrid markets, such as Japan.

On March 31, 2025, we closed the sale of our Teva-Takeda business venture in Japan. The business venture included generic products and legacy products.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended March 31, 2025 and 2024:


Three months ended March 31,


2025


2024


(U.S. $ in millions / % of Segment Revenues)

Revenues

$

582

100%

$

597

100%

Cost of sales


304

52.3%


300

50.3%

Gross profit


278

47.7%


297

49.7%

R&D expenses


25

4.3%


28

4.6%

S&M expenses


118

20.2%


118

19.8%

G&A expenses


39

6.7%


35

5.8%

Other


(1)

§


§

§

Segment profit*

$

97

16.7%

$

117

19.6%

* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.


Revenues from our International Markets segment in the first quarter of 2025 were $582 million, a decrease of 2% compared to the first quarter of 2024. In local currency terms, revenues increased by 5% compared to the first quarter of 2024. This decrease was mainly due to higher revenues from AJOVY as well as generic products in most markets, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.

In the first quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $44 million, including hedging effects, compared to the first quarter of 2024. Revenues in the first quarter of 2025 included $15 million from a negative hedging impact, compared to a positive hedging impact of $4 million in the first quarter of 2024, which are included in "Other" in the table below.

Revenues by Major Products and Activities

The following table presents revenues for our International Markets segment by major products and activities for the three months ended March 31, 2025 and 2024:



Three months ended
March 31,


Percentage
Change


2025


2024


2025-2024


(U.S. $ in millions)


Generic products (including OTC and biosimilars)


$

468


$

477


(2%)

AJOVY


28


17


65%

AUSTEDO


15


14


4%

COPAXONE


10


12


(11%)

Other*


61


77


(21%)

Total


$

582


$

597


(2%)

* Other revenues in the first quarter of 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $468 million in the first quarter of 2025, a decrease of 2% compared to the first quarter of 2024. In local currency terms, revenues increased by 2% compared to the first quarter of 2024, mainly due to higher revenues in most markets, largely driven by price increases as a result of higher costs due to inflationary pressure in certain markets and higher volumes, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.

AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the first quarter of 2025 were $28 million, compared to $17 million in the first quarter of 2024, due to growth in existing markets in which AJOVY was launched.

AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China. We continue to pursue additional submissions in various other markets.

AUSTEDO revenues in our International Markets segment in the first quarter of 2025 were $15 million compared to $14 million in the first quarter of 2024. In local currency terms, revenues increased by 6%, substantially due to the launch of a strategic partnership in China.

COPAXONE revenues in our International Markets segment in the first quarter of 2025 were $10 million compared to $12 million in the first quarter of 2024.

International Markets Gross Profit

Gross profit from our International Markets segment in the first quarter of 2025 was $278 million, a decrease of 6% compared to $297 million in the first quarter of 2024.

Gross profit margin for our International Markets segment in the first quarter of 2025 decreased to 47.7%, compared to 49.7% in the first quarter of 2024. This decrease was mainly due to a negative hedging impact, as well as regulatory price reductions and generic competition to off-patented products in Japan.

International Markets Profit

Profit of our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items. Profit from our International Markets segment in the first quarter of 2025 was $97 million, a decrease of 17%, compared to $117 million in the first quarter of 2024. This decrease was mainly due to lower gross profit, as discussed above.

Other Activities

We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above.

On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all.

Revenues from other activities in the first quarter of 2025 were $206 million, a decrease of 9% in U.S. dollars or 8% in local currency terms, compared to the first quarter of 2024, mainly due to a decrease in revenues from contract manufacturing services in the first quarter of 2025.

API sales to third parties in the first quarter of 2025 were $130 million, reflecting an increase of 2% in both U.S. dollars and local currency terms, compared to the first quarter of 2024.

Outlook for 2025 Non-GAAP Results

$ billions, except EPS or as noted


January 2025 Outlook


May 2025 Outlook

Revenues*


$16.8 – $17.4


$16.8 – $17.2

AUSTEDO ($m)*


1,900-2,050


1,950-2,050

AJOVY ($m)*


~600


~600

UZEDY ($m)*


~160


~160

COPAXONE ($m)*


~370


~370

Operating Income


4.1 – 4.6


4.3 – 4.6

Adjusted EBITDA


4.5 – 5.0


4.7 – 5.0

Tax Rate


15%-18%


15%-18%

Finance Expenses


~0.9


~0.9

Diluted EPS ($)


2.35 – 2.65


2.45 – 2.65

Free Cash Flow**


1.6 – 1.9


1.6 – 1.9

CAPEX*


~0.5


~0.5

Foreign Exchange


Volatile swings in FX can negatively impact revenue and income

* Revenues and CAPEX presented on a GAAP basis.
** Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Wednesday, May 7, 2025 at 8:00 a.m. ET to discuss its first quarter 2025 financial results and overall business environment.

A question & answer session will follow.

In order to participate, please register in advance here to obtain a local or toll‐free phone number and your personal pin.

A live webcast of the call will be available on Teva’s website at: www.tevapharm.com

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website.

Syndax Announces Publication of Pivotal Revumenib Data in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia in the Journal Blood

On May 7, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that data from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) have been published in Blood (Press release, Syndax, MAY 7, 2025, View Source [SID1234652651]).

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"We are thrilled to publish the first positive pivotal dataset in patients with an NPM1 mutation, the most common genetic alteration observed in AML," said Neil Gallagher, M.D., Ph.D., President, Head of Research and Development at Syndax. "These important data support the safety and efficacy of revumenib in relapsed or refractory mNPM1 AML and serve as the foundation for the sNDA we submitted to the FDA under its RTOR program."

"These are impressive, landmark results which underscore the potential for revumenib to meaningfully advance the standard of care for patients with R/R mNPM1 AML, a difficult to treat disease with a poor prognosis," said Martha L. Arellano, M.D., Professor of Hematology and Oncology, Winship Cancer Institute of Emory University, and Principal Investigator in the AUGMENT-101 trial. "In the older, heavily pretreated population enrolled in this trial, it is very encouraging to observe that nearly 50% of patients achieved an overall response and that revumenib was generally well-tolerated. These findings add to the growing body of evidence supporting revumenib’s paradigm-changing potential as treatment for a significant subset of acute leukemias."

In November 2024, revumenib was FDA approved as Revuforj for the treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older. In April 2025, Syndax completed the submission of a supplemental New Drug Application (sNDA) for revumenib in R/R mNPM1 AML under the FDA’s Real-Time Oncology Review (RTOR) program. The sNDA is supported by the positive pivotal data reported from the Phase 2 portion of the AUGMENT-101 trial.

About the published data

The publication entitled "Menin inhibition with revumenib for NPM1-mutated (NPM1m) relapsed or refractory acute myeloid leukemia: AUGMENT-101" reports results from patients with R/R mNPM1 AML who received revumenib in the pivotal Phase 2 portion of the AUGMENT-101 trial.

The protocol-defined efficacy-evaluable population for the primary analysis included the first 64 adult patients with R/R mNPM1 AML. In this efficacy population, the median age was 65 (range: 19, 84). Patients were heavily pretreated with 36% having received three or more prior lines of therapy and 22% having received four or more prior lines of therapy (median prior lines: 2). 75% of patients were previously treated with venetoclax.

The study met the primary efficacy endpoint with a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23% (15/64; 95% confidence interval [CI]: 14%-36%; one-sided p-value =0.0014). The median time to first CR+CRh was 2.76 months (range: 1.8-8.8) and the median duration of CR+CRh was 4.7 months (95% CI: 1.2-8.2). Responses were observed across the various subgroups assessed, including patients with multiple prior lines of therapy, prior venetoclax exposure, prior HSCT, and prior FLT3 inhibitor use.

The overall response rate (ORR)1 was 47% (30/64). Of the responders, 17% (5/30) proceeded to hematopoietic stem cell transplant (HSCT) while in remission, with three patients resuming revumenib after HSCT. The duration of therapy with revumenib post-transplant ranged from 2 to 60 weeks.

In this single-arm trial, the median overall survival (OS) observed was 4.0 months (95% CI: 2.5-7.2) among all 64 adults in the primary efficacy analysis based on the Kaplan-Meier estimate. The median OS observed was 23.3 months (95% CI: 7.2-not reached) among the 15 CR+CRh responders based on the Kaplan-Meier estimate.

The safety population included 84 adult and pediatric patients with R/R mNPM1 AML. The safety profile observed with revumenib in this population was consistent with previously reported data. Treatment-emergent serious adverse events that occurred in ≥5% of patients included: febrile neutropenia (21%), differentiation syndrome (13%), sepsis (13%), pneumonia (8%), anemia (7%), and QTc prolongation (7%). TEAEs leading to dose reduction or treatment discontinuations occurred in 12% (10/84) and 30% (25/84) of patients, respectively.

About Mutant NPM1 (mNPM1) Acute Myeloid Leukemia (AML)

Mutations in the NPM1 gene are the most common genetic alteration in adult AML and are observed in approximately 30% of cases. Patients with relapsed or refractory mNPM1 AML have a poor prognosis and high unmet need. Similar to KMT2A-rearranged acute leukemia, mNPM1 AML is highly dependent on the expression of specific developmental genes shown to be negatively impacted by inhibitors of the menin-KMT2A interaction. mNPM1 AML is routinely diagnosed through currently available screening techniques. There are currently no approved targeted therapies for mNPM1 AML.

About Revuforj (revumenib)

Revuforj (revumenib) is an oral, first-in-class, selective menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.

Revumenib is in development for the treatment of R/R acute myeloid leukemia (AML) with a nucleophosmin 1 mutation (mNPM1). Positive pivotal data from the AUGMENT-101 trial in this population with revumenib as a monotherapy were recently reported and the Company submitted a supplemental NDA for revumenib in R/R mNPM1 AML in April 2025. Additionally, multiple trials of revumenib in combination with standard-of-care agents in mNPM1 AML or KMT2A-rearranged acute leukemia are ongoing or planned across the treatment landscape, including in newly diagnosed patients.

Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS

Differentiation syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, and/or hypotension. In clinical trials, DS occurred in 39 (29%) of 135 patients treated with Revuforj. DS was Grade 3 or 4 in 13% of patients and fatal in one. The median time to onset was 10 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10-mg IV every 12 hours in adults or dexamethasone 0.25-mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc interval prolongation: In the clinical trials, QTc interval prolongation was reported as an adverse reaction in 39 (29%) of 135 patients treated with Revuforj. QTc interval prolongation was Grade 3 in 12% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 8%, and the increase from baseline QTcF was greater than 60 msec in 18%. Revuforj dose reduction was required for 5% of patients due to QTc interval prolongation. QTc prolongation occurred in 16% of the 31 patients less than 17 years old, 33% of the 88 patients 17 years to less than 65 years old, and in 50% of the 16 patients 65 years or older.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.
Embryo-fetal toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 4 (3%) patients who received Revuforj, including 2 with differentiation syndrome, 1 with hemorrhage, and 1 with sudden death.

Serious adverse reactions were reported in 99 (73%) patients. The most frequent serious adverse reactions (≥5%) were infection (24%), febrile neutropenia (19%), bacterial infection (17%), differentiation syndrome (12%), hemorrhage (9%), and thrombosis (5%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were hemorrhage (53%), nausea (51%), phosphate increased (50%), musculoskeletal pain (42%), infection (41%), aspartate aminotransferase increased (37%), febrile neutropenia (35%), alanine aminotransferase increased (33%), parathyroid hormone intact increased (33%), bacterial infection (31%), diarrhea (30%), differentiation syndrome (29%), electrocardiogram QT prolonged (29%), phosphate decreased (25%), triglycerides increased (25%), potassium decreased (24%), decreased appetite (24%), constipation (23%), edema (23%), viral infection (23%), fatigue (22%), and alkaline phosphatase increased (21%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

Strong CYP3A4 inhibitors: reduce Revuforj dose
Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec.
SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNING.