Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid Tumors

On April 29, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment of adults with desmoid tumors.

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"The varegacestat NDA submission marks an important milestone for Immunome. It reflects the strength of the RINGSIDE dataset and the commitment of the team advancing this program," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We believe varegacestat has the potential to provide adults with progressing desmoid tumors with a meaningful new oral treatment option, and we are grateful to the patients, families, investigators and study site teams whose participation made this submission possible."

The NDA is supported by positive results from the global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors.

The trial met its primary endpoint of improving progression-free survival, demonstrating a statistically significant and clinically meaningful improvement vs. placebo, with an 84% reduction in the risk of disease progression or death (hazard ratio (HR) = 0.16, 95% CI: 0.071, 0.375; p<0.0001). The confirmed objective response rate (ORR) based on RECIST v1.1 was 56% with varegacestat vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review.

In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review. In addition, the trial met all key secondary endpoints, with varegacestat achieving statistically significant improvements vs. placebo in landmark tumor volume reduction and worst pain intensity.

Varegacestat was generally well tolerated, with a manageable safety profile consistent with the GSI class. The most common adverse events for participants in the treatment arm were diarrhea (82%), fatigue (44%), rash (43%), nausea (35%) and cough (34%). Most events were grade 1 or 2.

Immunome previously announced that data from RINGSIDE has been selected for presentation in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2, 2026 in Chicago.

About the RINGSIDE Trial

The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (NCT04871282) evaluated the efficacy and safety of varegacestat in patients with progressing desmoid tumors. A total of 156 patients were randomized to receive varegacestat 1.2 mg daily or placebo until disease progression or death, representing the largest randomized study in this population. The primary endpoint of the trial was progression-free survival as assessed by blinded independent central review. Statistically controlled secondary endpoints were confirmed ORR using RECIST v1.1 and change in tumor volume at week 24, both determined by blinded independent central review, as well as change in pain intensity at week 12 as determined using a patient reported outcome instrument. Additional secondary endpoints included duration of response, best reduction in tumor volume, patient-reported outcomes, and safety and tolerability. RINGSIDE includes an open-label extension phase, which is ongoing.

About Desmoid Tumors

Desmoid tumors (also known as aggressive fibromatosis or desmoid-type fibromatosis) are aggressive non-metastatic soft tissue tumors that are prone to recurrence. Approximately 1,000-1,650 people are diagnosed with desmoid tumors each year in the United States, and there are approximately 10,000-11,000 actively managed patients. Those affected face debilitating pain, deformity and, in some cases, life-threatening organ damage. The chronic pain and physical limitations associated with desmoid tumors lead to a high clinical burden and impaired quality of life. Although desmoid tumors are not considered cancerous, they often require systemic treatment to prevent permanent disability and alleviate disease burden.

About Varegacestat

Varegacestat (formerly AL102) is an investigational, oral, once-daily gamma secretase inhibitor. In December 2025, Immunome reported positive topline results for the Phase 3 RINGSIDE trial of varegacestat in adults with progressing desmoid tumors. Data from RINGSIDE have been selected for oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.

(Press release, Immunome, APR 29, 2026, View Source [SID1234664917])

Tempest to Advance Dual-Targeting CAR-T Platform with Clinical Update at ISCT 2026 Annual Meeting

On April 29, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest") reported it will present its most recent clinical data from its lead dual-targeting chimeric antigen receptor T-cell ("CAR-T") therapy product candidate, TPST-2003, at the International Society for Cell & Gene Therapy ("ISCT") Scientific Annual Meeting in Dublin, May 6-9, 2026. Updates will include the latest data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, as well as progress in Tempest’s other dual-targeting CAR-T pipeline programs.

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Earlier this year, Tempest announced positive interim data from REDEEM-1, including a 100% complete response rate among all six efficacy then-evaluable patients according to the International Myeloma Working Group (IMWG) uniform response criteria, as well as a favorable safety profile.

"We look forward to sharing the latest results from REDEEM-1 and updates on our other dual-targeting CAR-T programs at ISCT," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "We believe that the results that we announced earlier this year suggest that TPST-2003 could offer a safe, effective option for patients with relapsed/refractory multiple myeloma ("rrMM"), and we continue to believe that replicating these results in the remainder of the REDEEM-1 trial and in a registrational trial would position TPST-2003 as a class-leading therapy for rrMM."

Presentation Details

REDEEM-1, a multicenter open-label Phase 1/2a study of a BCMA/CD19 dual-targeting CAR-T therapy in patients with relapsed/refractory multiple myeloma including those with extramedullary disease. Abstract #1268. Oral Presentation, May 6, 2026 (12:00-13:00 GMT) & Poster Reception, May 7, 2026 (18:00-19:30 GMT), Immunotherapy Session. Presenter: Dr. Matt Angel.

About TPST-2003

TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma ("rrMM") through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics ("Novatim"). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia.

About REDEEM-1

REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The REDEEM-1 trial has a targeted full enrollment of 29 patients. The REDEEM-1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of eight clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), The First Affiliated Hospital of Nanchang University (Dr. Fei Li), Peking University First Hospital (Dr. Yujin Dong), Henan Cancer Hospital (Dr. Baijun Fang), Shanxi Provincial Cancer Hospital (Dr. Liping Su), The Second Xiangya Hospital of Central South University (Dr. Hongling Peng), The First Affiliated Hospital of China Medical University (Dr. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou).

Additional Clinical Trials Evaluating TPST-2003

A Phase 1/2 IIT (Study no. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su).

A Phase 1 trial (Study nos. CTR20242409/NCT06518876) is evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. The Phase 1 trial is sponsored and being conducted by Tempest’s partner, Novatim, with a total of three clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), Xuanwu Hospital Capital Medical University (Dr. Wanling Sun), and West China Hospital, Sichuan University (Dr. Yu Wu).

(Press release, Tempest Therapeutics, APR 29, 2026, View Source [SID1234664898])

Pfizer’s ELREXFIO Significantly Improves Progression-Free Survival for Double-Class Exposed Patients with Relapsed or Refractory Multiple Myeloma

On April 29, 2026 Pfizer Inc. (NYSE: PFE) reported positive topline results from the Phase 3 MagnetisMM-5 study evaluating ELREXFIO (elranatamab) as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment. The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression‑free survival (PFS), as assessed by blinded independent central review (BICR), versus standard-of-care daratumumab plus pomalidomide and dexamethasone (DPd). The safety and tolerability of ELREXFIO was consistent with its known safety profile.

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The PFS results exceeded the pre-specified interim analysis target hazard ratio for efficacy, with most ELREXFIO-treated patients remaining progression-free. The trial remains ongoing to assess overall survival, a key secondary endpoint, which was not yet mature at the time of this interim analysis. These data will be discussed with global health authorities, and detailed results from MagnetisMM-5 will be submitted for presentation at a future medical congress.

Multiple myeloma is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow:

It is the second most common type of blood cancer worldwide, with over 36,000 new cases each year in the United States and over 187,000 globally.1,2,3
Despite treatment advances, most patients relapse and develop relapsed or refractory disease, often requiring multiple lines of therapy, with approximately 40% not surviving beyond five years.2,4
Multiple myeloma can significantly impact quality of life, with immune suppression increasing susceptibility to infection, and symptoms such as fatigue, bone pain, and psychological distress making everyday activities more difficult.5-7
"Effective intervention earlier in the course of disease represents a critical opportunity to improve outcomes for people living with multiple myeloma," said Jeff Legos, Chief Oncology Officer, Pfizer. "ELREXFIO has already helped address a significant unmet need in heavily pre‑treated patients, delivering deep, durable, and clinically meaningful responses. The MagnetisMM-5 results reinforce our confidence in ELREXFIO’s potential to benefit patients earlier in their treatment journey and support our comprehensive strategy to evaluate ELREXFIO both as monotherapy and as part of combination approaches across multiple lines of therapy."

ELREXFIO is approved in more than 35 countries worldwide, including in the United States where it received accelerated approval for use in adults with RRMM who have received at least four prior lines of therapy, and in the European Union where it was granted conditional marketing authorization for adults with RRMM who have received at least three prior therapies and have demonstrated disease progression on the last therapy.

MagnetisMM-5 is part of a comprehensive development program in double-class exposed MM patients. The program includes the fully recruited Phase 3 MagnetisMM-32 study, which is designed to evaluate ELREXFIO in patients who have previously received daratumumab as part of standard-of-care front-line MM treatment.

About Multiple Myeloma
Multiple myeloma is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection.6 While disease trajectory varies for each person, relapses are nearly inevitable.9 The goal of therapy for people with relapsing or refractory multiple myeloma is to achieve disease control with acceptable toxicity and improved quality of life.10

About MagnetisMM-5
MagnetisMM-5 is an open-label, multicenter, randomized Phase 3 study to evaluate the efficacy and safety of ELREXFIO versus standard-of-care daratumumab plus oral pomalidomide and dexamethasone in patients with RRMM. The study enrolled 497 patients across 26 countries who have received at least one line of previous treatment, including lenalidomide and a proteasome inhibitor (PI). Participants received subcutaneous ELREXFIO as two step-up priming doses followed by a weekly 76 mg injection, with frequency adjusted to every two weeks after 24 weeks if a partial response was achieved for more than two months, and again to every four weeks for all patients after 48 weeks on treatment. The primary endpoint is progression-free survival (PFS), as assessed by blinded independent central review (BICR). A key secondary endpoint is overall survival.

Pfizer continues to evaluate ELREXFIO both as a monotherapy and as a combination regimen as part of the MagnetisMM clinical trial program.

About ELREXFIO (elranatamab)
ELREXFIO is a subcutaneously delivered B-cell maturation antigen (BCMA)-cluster of differentiation CD3-directed bispecific antibody immunotherapy that binds to BCMA on myeloma cells and CD3 on T cells, activating the T cells to kill myeloma cells.

U.S. Important Safety Information and Indication

ELREXFIO may cause side effects that are serious, life-threatening, or can lead to death, including cytokine release syndrome (CRS) and neurologic problems. CRS is common during treatment with ELREXFIO.

Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS or neurologic problems, including:

fever of 100.4°F (38°C) or higher
trouble breathing
chills
dizziness or light-headedness
fast heartbeat
headache
increased liver enzymes in your blood
agitation, trouble staying awake, confusion or disorientation, or seeing or hearing things that are not real (hallucinations)
trouble speaking, thinking, remembering things, paying attention, or understanding things
problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms
numbness and tingling (feeling like "pins and needles")
burning, throbbing, or stabbing pain
changes in your handwriting
Due to the risk of CRS, you will receive ELREXFIO on a "step-up" dosing schedule and should be hospitalized for 48 hours after the first "step-up" dose and for 24 hours after the second "step-up" dose of ELREXFIO.

For your first dose, you will receive a smaller "step-up" dose of ELREXFIO on day 1
For your second dose, you will receive a larger "step-up" dose of ELREXFIO, which is usually given on day 4 of treatment
For your third dose, you will receive the first "treatment" dose of ELREXFIO, which is usually given on day 8
If your dose of ELREXFIO is delayed for any reason, you may need to repeat step-up dosing. Before each dose of ELREXFIO during the step-up dosing schedule, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.

ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) Program due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists signs and symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the signs and symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Before taking ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:

have an infection
are pregnant or plan to become pregnant. ELREXFIO may harm your unborn baby. Females who are able to become pregnant should do a pregnancy test before starting treatment with ELREXFIO and should use effective birth control during treatment and for four months after your last dose of ELREXFIO. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with ELREXFIO
are breastfeeding or plan to breastfeed. It is not known if ELREXFIO passes into your breast milk. Do not breastfeed during treatment and for four months after your last dose of ELREXFIO
Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.

Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities during treatment with ELREXFIO:

for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the "step-up dosing schedule" and your first full treatment dose, and
at any time during treatment with ELREXFIO if you develop any new neurologic symptoms, such as dizziness, confusion, shaking (tremors), sleepiness, or any other symptom that impairs consciousness, until the symptoms go away
Infections: Upper respiratory tract infection and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.

Your healthcare provider may prescribe medications for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including: fever of 100.4°F (38°C) or higher, chills, cough, shortness of breath, chest pain, sore throat, pain during urination, or feeling weak or generally unwell
People with active infections should not start ELREXFIO
Decreased white blood cell counts: Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. A fever can occur with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.

Liver problems: ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of a liver problem, including:

tiredness
loss of appetite
pain in your right upper stomach-area
dark urine
yellowing of your skin or the white part of your eyes
The most common side effects of ELREXFIO include:

tiredness
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, and tenderness
diarrhea
muscle and bone pain
decreased appetite
rash
cough
nausea
fever
The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.

Your healthcare provider may temporarily or permanently stop ELREXFIO if you have any of the side effects listed and they are severe. These are not all of the possible side effects of ELREXFIO.

Call your healthcare provider for medical advice about side effects. You may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088.

What is ELREXFIO?

ELREXFIO is a prescription medication used to treat adults with multiple myeloma who:

have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, to treat their multiple myeloma, and
their cancer has come back or did not respond to prior treatment
ELREXFIO was approved based on patient responses and durability of response. There are ongoing studies to confirm its clinical benefit. It is not known if ELREXFIO is safe and effective in children.

Please read full Prescribing Information, including BOXED WARNING, for ELREXFIO.

(Press release, Pfizer, APR 29, 2026, View Source [SID1234664918])

Teva Delivers Strong Q1 2026 Results Driven by Innovative Portfolio Growth and Disciplined Execution

On April 29, 2026 Teva reported Strong Q1 2026 Results Driven by Innovative Portfolio Growth and Disciplined Execution.

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Q1 2026 revenues of ~$4.0 billion increased by 2% in U.S. dollars year-over-year (YoY), and decreased by 3% in local currency terms (LC). Excluding the Japan business venture (BV) results, revenues decreased by 1% in LC. These strong first quarter results were driven by our innovative portfolio growth and disciplined execution, even with lower revenues from lenalidomide capsules (the generic version of Revlimid) due to increased generic competition in the U.S.
Key Innovative brands continued to drive growth and provide value for patients, while transforming Teva’s portfolio mix and financial profile:
AUSTEDO continued to show strong growth, with global revenues of $578 million, growing 41% YoY in LC.
AJOVY global revenues of $196 million, increased by 35% YoY in LC.
UZEDY revenues of $63 million, increased by 62% YoY in LC. Fastest growing long-acting injectable (LAI)1 has nearly doubled the overall risperidone market since launch.
Collectively these brands’ revenues grew by 41% YoY in LC.
Generics revenues are lower in Q1 2026 vs. Q1 2025, mainly due to lenalidomide capsules (the generic version of Revlimid) impact; Biosimilar portfolio increasingly important contributor to performance and on track to deliver $800 in revenues by 2027:
Global generics revenues decreased by 16% YoY in LC, mainly due to lower revenues from generic products in the U.S., primarily lenalidomide capsules (the generic version of Revlimid) due to increased generic competition in the U.S., and the divestment of the business venture in Japan in Q1 2025.
Biosimilar PONLIMSI, received FDA-approval across all indications of the reference product, Prolia (denosumab) and our biosimilar candidate to Xolair (omalizumab) was accepted for review by U.S. FDA and EU EMA (link).
Innovative late-stage pipeline continued to drive transformation:
Four innovative product submissions targeted over the next 5 years.
duvakitug (anti-TL1A) Phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis (UC) and Crohn’s disease (CD); Phase 2b induction data have been accepted for future publication in a leading journal; Phase 3 enrollment currently on target.
olanzapine LAI New Drug Application (NDA) accepted by the FDA in February 2026 for once-monthly treatment of schizophrenia in adults; preparing for the launch of olanzapine LAI in Q4 2026, subject to regulatory approval. EU marketing authorization application (MAA) acceptance expected in Q2 2026.
Teva to acquire Emalex Biosciences, adding NDA-Ready, first-in-class therapy to neuroscience pipeline and accelerating Teva’s Pivot to Growth strategy. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close by the third quarter of 2026 (link).
Continuing to transform and modernize our business through Teva Transformation programs – combined with innovative product growth, expected to achieve 30% non-GAAP operating income margin by 2027. On track to deliver ~$700 million of net savings by 2027.
Teva’s Board of Directors instructed management to plan for a share repurchase program that may be implemented, subject to meeting applicable legal requirements. Execution will be subject to certain factors, such as market conditions, share price and other opportunities to invest capital for growth in alignment with the Company’s Pivot to Growth strategy, and are subject to the approval by Teva’s Board of Directors.

Q1 2026 Highlights:

Revenues of $4.0 billion
GAAP diluted EPS of $0.31
Non-GAAP diluted EPS of $0.53
Cash flow used in operating activities of $40 million
Free cash flow of $188 million

2026 Business Outlook maintained; updated exclusively for Emalex transaction:

Revenues of $16.4 – $16.8 billion
Non-GAAP operating income of $3.80 – $4.0 billion ($4.55 – $4.8 billion stand-alone), impacted by an expected $700 million IPR&D charge and $75 million to reflect Emalex’s operating expenses and transaction-related expenses.
Adjusted EBITDA of $4.23 – $4.53 billion ($5.0 – $5.3 billion stand-alone)
Non-GAAP diluted EPS of $1.91 – $2.11 ($2.57 – $2.77 stand-alone)
Free cash flow of $2.0 – $2.4 billion
________________
1 IQVIA Monthly NPA, March 2026 MAT vs PY

TEL AVIV, Israel, April 29, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended March 31, 2026.

Mr. Richard Francis, Teva’s President and CEO, said: "Our first quarter results are driven by strong growth in our key innovative products, continuing to shift Teva’s portfolio mix and support improvement in its financial profile. These results reflect disciplined execution of our Pivot to Growth strategy, and our focus remains unchanged: growing our innovative portfolio, improving margins and advancing key value-unlocking portfolio milestones expected during 2026 and beyond.

Mr. Francis added, "In parallel, biosimilars are becoming an increasingly important growth contributor, alongside new product launches in generics, reinforcing the foundational importance of Teva’s generic powerhouse.

Pivot to Growth Strategy

In the first quarter of 2026, we continued to execute on the four key pillars of our "Pivot to Growth" strategy, announced in May 2023:

Delivering on our growth engines – Teva’s key innovative brands delivered strong performance. In Q1 2026, AUSTEDO, AJOVY, and UZEDY revenues collectively grew by 41% YoY in LC to $838 million compared to Q1 2025. Based on our 2026 Outlook, these products are expected to generate an annual 4-year compound growth rate of ~38% and comprise ~21% of Teva’s total revenues.
Stepping up innovation – We continued to advance our innovative late-stage pipeline. In February 2026, we shared topline results from the maintenance period of our Phase 2b study of duvakitug in UC and CD. The data demonstrated robust, durable efficacy over the course of 44 weeks, and positions duvakitug to potentially be the "best-in-class" anti-TL1A. Phase 3 enrollment is currently on target. Teva’s NDA for olanzapine LAI was accepted by the FDA in February 2026. Teva is preparing for the anticipated launch of olanzapine LAI in Q4 2026, subject to receiving regulatory approval. During the remainder of 2026, Teva expects meaningful data updates on five other key innovative programs, including: emrusolmin in MSA, IL-15 (TEV-‘408) in Celiac disease and vitiligo, DARI (Dual-action Asthma Rescue Inhaler) in asthma, and Anti-PD-1/IL-2 in oncology.
Sustaining our generics powerhouse – Recently launched biosimilars, including SELARSDI (ustekinumab-aekn) the biosimilar to Stelara and EPYSQLI(eculizumab-aagh) the biosimilar to Soliris, along with the rest of our biosimilar portfolio, showed continued strong growth in the Q1 2026. In March 2026, PONLIMSI (denosumab-adet) has been approved by the FDA as a biosimilar to Prolia, and Teva’s applications for a proposed biosimilar candidate to Xolair (omalizumab) have been accepted by both the U.S. FDA and the European Medicines Agency (EMA).
Focusing our business – We are actively transforming and modernizing our business through Teva Transformation programs. On May 7, 2025, we announced that these programs are expected to generate ~$700 million of net savings through 2027, and expect to realize two-thirds of the targeted savings in 2026. In April 2026, Teva entered into a definitive agreement to acquire Emalex Biosciences, including its lead asset ecopipam. Emalex has completed Phase 3 development of ecopipam for the treatment of Tourette syndrome in a pediatric population. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close by the third quarter of 2026 (link).

First Quarter 2026 Consolidated Results

Revenues in the first quarter of 2026 were $3,982 million, an increase of 2% in U.S. dollars, or a decrease of 3% in local currency terms compared to the first quarter of 2025. This decrease in local currency terms was mainly due to lower revenues from generic products, primarily lenalidomide capsules (the generic version of Revlimid) in our U.S. segment as well as the divestment of our business venture in Japan in our International Markets segment, partially offset by higher revenues from our key innovative products, primarily AUSTEDO.

Exchange rate movements during the first quarter of 2026, including hedging effects, positively impacted revenues by $219 million, compared to the first quarter of 2025.

Gross profit in the first quarter of 2026 was $1,972 million, an increase of 5% compared to $1,877 million in the first quarter of 2025. Gross profit margin was 49.5% in the first quarter of 2026, compared to 48.2% in the first quarter of 2025. Non-GAAP gross profit was $2,108 million in the first quarter of 2026, an increase of 3% compared to $2,054 million in the first quarter of 2025. Non-GAAP gross profit margin was 52.9% in the first quarter of 2026, compared to 52.8% in the first quarter of 2025. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to higher revenues from AUSTEDO, partially offset by lower revenues from generic products in our United States segment, primarily lenalidomide capsules (the generic version of Revlimid).

Research and Development (R&D) expenses, net in the first quarter of 2026, were $222 million, a decrease of 10% compared to $247 million in the first quarter of 2025. Our lower R&D expenses, net in the first quarter of 2026 compared to the first quarter of 2025, were mainly due to a decrease in our generics pipeline and in our late-stage innovative pipeline in neuroscience, partially offset by an increase in immunology projects. Our R&D expenses, net in the first quarter of 2026 and 2025, were also impacted by reimbursements and cost sharing from our strategic partnerships and collaborations entered into in recent years.

Selling and Marketing (S&M) expenses in the first quarter of 2026, were $696 million, an increase of 12% compared to the first quarter of 2025. This increase was mainly due to promotional activities related to our key innovative products in our US segment, primarily AUSTEDO, as well as a negative impact from exchange rate fluctuations.

General and Administrative (G&A) expenses in the first quarter of 2026 were $304 million, an increase of 2% compared to the first quarter of 2025.

Other Income (Loss) in the first quarter of 2026 was $9 million, compared to other loss of $5 million in the first quarter of 2025.

Operating Income in the first quarter of 2026 was $652 million, compared to $519 million in the first quarter of 2025. Operating income as a percentage of revenues was 16.4% in the first quarter of 2026, compared to 13.3% in the first quarter of 2025. This increase was mainly due to lower intangible assets impairments and higher gross profit, partially offset by higher S&M expenses. Non-GAAP operating income in the first quarter of 2026 was $956 million representing a non-GAAP operating margin of 24.0% compared to $946 million representing 24.3%, respectively, in the first quarter of 2025. The decrease in non-GAAP operating margin in the first quarter of 2026 was due to higher S&M expenses as a percentage of revenues, partially offset by higher gross profit margin, as discussed above.

Exchange rate movements in the first quarter of 2026, including hedging effects, had a positive impact of $71 million on our operating income and non-GAAP operating income compared to the first quarter of 2025.

Financial expenses, net in the first quarter of 2026, were $216 million, mainly comprised of net interest expenses of $201 million. In the first quarter of 2025, financial expenses, net were $225 million, mainly comprised of net interest expenses of $212 million.

In the first quarter of 2026, we recognized a tax expense of $67 million, on pre-tax income of $437 million. In the first quarter of 2025, we recognized a tax expense of $74 million, on pre-tax income of $294 million.

Tax rate in the first quarter of 2026 was 15.5% compared to a tax rate of 25.1% for the first quarter of 2025. Non-GAAP tax rate in the first quarter of 2026 was 17.5%, same as in the first quarter of 2025. Our tax rate and non-GAAP tax rate in the first quarter of 2026 was mainly affected by the generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate, infrequent or non-recurring items, including internal legal entities reorganization. Our tax rate and 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.

We expect our annual non-GAAP tax rate for 2026 to be between 20%-23% (16%-19% stand-alone), higher than our non-GAAP tax rate for 2025, which was 15.8%.

Net income attributable to Teva and diluted earnings per share in the first quarter of 2026 were $369 million and $0.31, respectively, compared to $214 million and $0.18, respectively, in the first quarter of 2025. This increase was mainly due to higher operating income as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the first quarter of 2026 were $621 million and $0.53, respectively, compared to $602 million and $0.52, respectively, in the first quarter of 2025.

Adjusted EBITDA was $1,055 million in the first quarter of 2026, an increase of 1%, compared to $1,041 million in the first quarter of 2025.

As of March 31, 2026 and 2025, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,192 million shares and 1,178 million shares, respectively.

Non-GAAP information: non-GAAP adjustments in the first quarter of 2026 were $252 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the first quarter of 2026 were adjusted to exclude the following items:

Amortization of purchased intangible assets of $137 million, of which $128 million is included in cost of sales and the remaining $9 million in S&M expenses;
Legal settlements and loss contingencies of $72 million;
Restructuring expenses of $25 million;
Impairment of long-lived assets of $9 million;
Contingent consideration expenses of $5 million;
Gain on sale of business of $5 million;
Equity compensation expenses of $43 million;
Financial expenses of $13 million;
Other non-GAAP items of $17 million; and
Corresponding tax effects and unusual tax items of $65 million.

We believe that excluding such items facilitates investors’ understanding of our business including underlying 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 2026 was $40 million compared to $105 million in the first quarter of 2025. The lower cash flow used in operating activities in the first quarter of 2026 was mainly due to favorable timing and mix of sales and collections in our U.S. segment as well as lower payments of interest, partially offset by higher performance incentive payments to employees.

During the first quarter of 2026, we generated free cash flow of $188 million, which we define as comprising $40 million in cash flow used in operating activities, $354 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $42 million of proceeds from sale of businesses and long-lived assets, partially offset by $168 million in cash used for capital investments. 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 sale of businesses and long-lived assets, partially offset by $127 million in cash used for capital investments. The increase in the first quarter of 2026 resulted mainly from lower cash flow used in operating activities, as discussed above.

As of March 31, 2026, our debt was $16,627 million, compared to $16,807 million as of December 31, 2025. This decrease was mainly due to $174 million of exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2026 was 16% compared to 11% as of December 31, 2025. Our financial leverage, which is the ratio between our debt and the sum of our debt and equity, was 67% as of March 31, 2026, compared to 68% as of December 31, 2025. Our average debt maturity was approximately 5.4 years as of March 31, 2026, compared to 5.6 years as of December 31, 2025.

Segment Results for the First Quarter of 2026

United States Segment

In alignment with our Pivot to Growth strategy, commencing January 1, 2026, Anda is no longer reported under our United States segment. This shift allows the United States segment to continue to manage its entire product portfolio in the region, while strengthening focus on its biopharmaceutical business, growth engines and innovation. As a result, from that date, Anda is reported as part of the Company’s Other Activities. Prior period amounts have been recast to reflect this change.

The following table presents revenues, expenses and profit for our United States segment for the three months ended March 31, 2026 and 2025:

Three months ended March 31,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,534 100% $ 1,536 100%
Cost of sales 496 32.3% 523 34.1%
Gross profit 1,038 67.7% 1,013 65.9%
R&D expenses 147 9.6% 154 10.1%
S&M expenses 298 19.4% 244 15.9%
G&A expenses 90 5.9% 95 6.2%
Other (4) § 3 §
Segment profit* $ 507 33.0% $ 518 33.7%

* 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 2026 were $1,534 million, flat compared to the first quarter of 2025, mainly due to lower revenues from our generic products, primarily lenalidomide capsules (the generic version of Revlimid), offset by higher revenues from our key innovative products, primarily AUSTEDO.

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, 2026 and 2025:

Three months ended
March 31, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including biosimilars) $ 612 $ 849 (28%)
AJOVY 87 53 64%
AUSTEDO 559 396 41%
BENDEKAand TREANDA 27 36 (26%)
COPAXONE 62 54 16%
UZEDY 63 39 62%
Other* 123 109 13%
Total $ 1,534 $ 1,536 §

*Other revenues in the first quarter of 2026 include the sale of certain product rights.
§ Represents an amount less than 0.5%.

Generic products (including biosimilar products) revenues in our United States segment in the first quarter of 2026 were $612 million, a decrease of 28% compared to the first quarter of 2025. This decrease was mainly driven by lower revenues from lenalidomide capsules (the generic version of Revlimid) due to increased generic competition in the U.S., partially offset by higher revenues from our portfolio of biosimilar products.

Among the most significant generic products we sold in the United States in the first quarter of 2026 were Truxima (the biosimilar to Rituxan), epinephrine injectable solution (the generic equivalent of EpiPen and EpiPen Jr) and SIMLANDI (the biosimilar to Humira). In the first quarter of 2026, our total prescriptions were approximately 246 million (based on trailing twelve months), representing 6.3% of total U.S. generic prescriptions, compared to approximately 273 million (based on trailing twelve months), representing 7.1% of total U.S. generic prescriptions in the first quarter of 2025, all according to IQVIA data.

AJOVY revenues in our United States segment in the first quarter of 2026 were $87 million, an increase of 64% compared to the first quarter of 2025, mainly due to a reduction in sales allowance. In the first quarter of 2026, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 32.0% out of the subcutaneous injectable anti- CGRP class, compared to 30.2% in the first quarter of 2025.

AUSTEDO revenues (which include AUSTEDO XR) in our United States segment in the first quarter of 2026 were $559 million, an increase of 41%, compared to in the first quarter of 2025. This increase was mainly due to growth in volume.

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 doses of 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 twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the first quarter of 2026 were $63 million, an increase of 62% compared to the first quarter of 2025, mainly due to growth in volume.

BENDEKA and TREANDA combined revenues in our United States segment in the first quarter of 2026 were $27 million, a decrease of 26% compared to the first quarter of 2025, mainly due to competition from alternative therapies, as well as from generic bendamustine products.

COPAXONE revenues in our United States segment in the first quarter of 2026 were $62 million, an increase of 16% compared to the first quarter of 2025, mainly due to a reduction in sales allowance, partially offset by lower volumes. COPAXONE continues to face competition from existing alternative therapies, generic versions of COPAXONE, and generic treatments for multiple sclerosis, injectable products, as well as from monoclonal antibodies.

United States Gross Profit

Gross profit from our United States segment in the first quarter of 2026 was $1,038 million, an increase of 2%, compared to the first quarter of 2025.

Gross profit margin for our United States segment in the first quarter of 2026 increased to 67.7%, compared to 65.9% in the first quarter of 2025. This increase was mainly due to higher revenues from AUSTEDO, partially offset by lower revenues from generic products, primarily lenalidomide capsules (the generic version of Revlimid).

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 2026 was $507 million, a decrease of 2% compared to the first quarter of 2025. This decrease was mainly due to higher S&M expenses, partially offset by 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, 2026 and 2025:

Three months ended March 31,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,340 100% $ 1,194 100%
Cost of sales 606 45.2% 536 44.9%
Gross profit 734 54.8% 658 55.1%
R&D expenses 45 3.4% 60 5.1%
S&M expenses 215 16.0% 199 16.7%
G&A expenses 73 5.4% 69 5.8%
Other § § § §
Segment profit* $ 401 29.9% $ 329 27.6%
* 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 Europe segment in the first quarter of 2026 were $1,340 million, an increase of 12%, compared to the first quarter of 2025. In local currency terms, revenues decreased by 1% compared to the first quarter of 2025, mainly due to lower revenues from generic products, partially offset by higher revenues from AJOVY.

In the first quarter of 2026, revenues were positively impacted by exchange rate fluctuations of $159 million, including hedging effects, compared to the first quarter of 2025. Revenues in the first quarter of 2026 included $10 million from a positive hedging impact, which is included in "Other" in the table below. 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 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, 2026 and 2025:

Three months ended
March 31, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 1,089 $ 989 10%
AJOVY 76 58 31%
COPAXONE 40 42 (4%)
Respiratory products 59 55 8%
Other* 76 50 52%
Total $ 1,340 $ 1,194 12%

* Other revenues in the first quarter of 2026 and 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our Europe segment in the first quarter of 2026 were $1,089 million, an increase of 10% compared to the first quarter of 2025. In local currency terms, revenues decreased by 1%, mainly due to lower sales of seasonal OTC products, partially offset by higher revenues from recently launched products.

AJOVY revenues in our Europe segment in the first quarter of 2026 were $76 million, an increase of 31% compared to the first quarter of 2025. In local currency terms revenues increased by 17% due to growth in volume.

COPAXONE revenues in our Europe segment in the first quarter of 2026 were $40 million, a decrease of 4% compared to the first quarter of 2025. In local currency terms revenues decreased by 14%, mainly due to price reductions and lower volumes resulting from the availability of alternative therapies.

Respiratory products revenues in our Europe segment in the first quarter of 2026 were $59 million, an increase of 8% compared to the first quarter of 2025. In local currency terms, revenues decreased by 2%, mainly due to net price reductions and lower volumes.

Europe Gross Profit

Gross profit from our Europe segment in the first quarter of 2026 was $734 million, an increase of 12% compared to the first quarter of 2025.

Gross profit margin for our Europe segment in the first quarter of 2026 decreased to 54.8%, compared to 55.1% in the first quarter of 2025.

Europe Profit

Profit from 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 2026 was $401 million, an increase of 22%, compared to the first quarter of 2025. This increase was mainly due to higher 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, and branded generics-oriented markets, such as Russia and certain Latin America markets.

On March 31, 2025, we divested our Teva-Takeda business venture in Japan, which included generic products and legacy products. Since the establishment of the business venture and until the completion of its sale, Teva held 51% of the outstanding common stock of the business venture. On March 31, 2025, we deconsolidated the business venture from our financial statements.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended March 31, 2026 and 2025:

Three months ended March 31,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 524 100% $ 582 100%
Cost of sales 280 53.6% 304 52.3%
Gross profit 243 46.4% 278 47.7%
R&D expenses 22 4.3% 25 4.3%
S&M expenses 117 22.3% 118 20.2%
G&A expenses 39 7.5% 39 6.7%
Other § § (1) §
Segment profit* $ 65 12.3% $ 97 16.7%

* 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 2026 were $524 million, a decrease of 10% compared to the first quarter of 2025. In local currency terms, revenues decreased by 19% compared to the first quarter of 2025, mainly due to the divestment of our business venture in Japan.

In the first quarter of 2026, revenues were positively impacted by exchange rate fluctuations of $50 million, including hedging effects, compared to the first quarter of 2025. Revenues in the first quarter of 2026 included $1 million from a positive hedging impact, compared to a negative hedging impact of $15 million in the first quarter of 2025, which are included in "Other" in the table below.

The following table presents revenues for our International Markets segment by major products and activities for the three months ended March 31, 2026 and 2025:

Three months ended
March 31, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 386 $ 468 (18%)
AJOVY 33 28 20%
AUSTEDO 19 15 30%
COPAXONE 6 10 (43%)
Other* 79 61 30%
Total $ 524 $ 582 (10%)

*Other revenues in the first quarter of 2026 and 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment in the first quarter of 2026 were $386 million, a decrease of 18% compared to the first quarter of 2025. In local currency terms, revenues decreased by 23%, mainly due to the divestment of our business venture in Japan.

AJOVY revenues in our International Markets segment in the first quarter of 2026 were $33 million, an increase of 20%, compared to $28 million in the first quarter of 2025. In local currency terms, revenues increased by 15%, mainly due to growth in existing markets in which AJOVY was launched. AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. In April 2026, we announced a strategic partnership for the marketing and distribution of AJOVY in China with Neurogen (Zhuhai) Pharmaceutical Company Ltd.

AUSTEDO revenues in our International Markets segment in the first quarter of 2026 were $19 million an increase of 30%, compared to the first quarter of 2025. In local currency terms, revenues increased by 22% compared to the first quarter of 2025. 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 with Jiangsu Nhwa Hexin Pharmaceutical Marketing Co., Ltd. In April 2025, AUSTEDO received marketing authorization in South Korea. We continue to evaluate additional submissions in various other markets.

COPAXONE revenues in our International Markets segment in the first quarter of 2026 were $6 million a decrease of 43% compared to the first quarter of 2025.

International Markets Gross Profit

Gross profit from our International Markets segment in the first quarter of 2026 was $243 million, a decrease of 12% compared to the first quarter of 2025.

Gross profit margin for our International Markets segment in the first quarter of 2026 decreased to 46.4%, compared to 47.7% in the first quarter of 2025. This decrease was mainly due to unfavorable mix of products, partially offset by a positive impact from hedging activities.

International Markets Profit

Profit from 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 2026 was $65 million, a decrease of 33%, compared to the first quarter of 2025. 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.

In alignment with our Pivot to Growth strategy, commencing January 1, 2026, Anda is no longer reported under our United States segment. This shift allows the United States segment to continue to manage its entire product portfolio in the region, while strengthening focus on its biopharmaceutical business, growth engines and innovation. As a result, from that date, Anda is reported as part of the Company’s Other Activities. Prior period amounts were recast to reflect this change.

Our revenues from other activities in the first quarter of 2026 were $584 million, an increase of 1% compared to the first quarter of 2025. In local currency terms, revenues decreased by 1% compared to the first quarter of 2025.

Anda revenues from third-party products in the first quarter of 2026 were $378 million, an increase of 1%, compared to the first quarter of 2025. Anda, our distribution business in the United States operates independently and distributes generic and innovative medicines and OTC pharmaceutical products from various manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda competes in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.

API sales to third parties in the first quarter of 2026 were $109 million, a decrease of 17% in both U.S. dollars and local currency terms, compared to the first quarter of 2025. This decrease was mainly due to price reductions and lower demand due to market dynamics.

Revenues from additional other activities, mainly from Medis and certain contract manufacturing services, in the first quarter of 2026 were $97 million, an increase of 28% in U.S. dollars compared to the first quarter of 2025. In local currency terms, revenues increased by 16% compared to the first quarter of 2025, mainly due to higher demand.

2026 Financial Outlook

$ billions, except diluted
EPS or as noted Stand-Alone Outlook
(Jan. 2026) Emalex April 2026
Revenues 16.4 – 16.8 16.4 – 16.8
AUSTEDO ($m) 2,400 – 2,550 2,400 – 2,550
AJOVY ($m) 750 – 790 750 – 790
UZEDY ($m) 250 – 280 250 – 280
Operating Income* 4.55 – 4.8 (0.77) 3.8 – 4.0
Adjusted EBITDA* 5.0 – 5.3 (0.77) 4.23 – 4.53
Finance Expenses* ($m) ~800 ~800
Tax Rate* 16% – 19% (+400 bps to ETR) 20% – 23%
Diluted EPS* ($) 2.57 – 2.77 (0.66) 1.91 – 2.11
Free Cash Flow* 2.0 – 2.4 2.0 – 2.4
CAPEX 0.5 0.5
Foreign Exchange Volatile swings in FX can negatively impact revenue and income

*Certain items above are non-GAAP financial measures. For more information, see "Non-GAAP Financial Measures" below. 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, April 29, 2026 at 8:00 a.m. ET to discuss its first quarter 2026 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.

(Press release, Teva, APR 29, 2026, View Source [SID1234664899])

OPTIMAL-PSMA Trial of TLX597-Tx Next Generation RLT Presented at IPCS 2026 Highlighting Therapeutic Potential in Prostate Cancer

On April 29, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported dosimetry results from the randomized Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration-resistant prostate cancer (mCRPC), presented at the 2026 International Prostate Cancer Symposium (IPCS 2026) held in Lugano, Switzerland. These findings support TLX597-Tx’s potential to deliver a treatment that overcomes quality-of-life challenges that currently limit the clinical utility of existing RLTs in earlier-stage metastatic prostate cancer.

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TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) is a novel PSMA-targeting small molecule RLT candidate with a highly favorable dosimetry profile. Significantly reduced radiation exposure to healthy organs, including the salivary glands and kidneys5, may lower the incidence of xerostomia (dry mouth) and renal toxicity and support better tolerability for patients. This dosimetry profile combined with higher tumor uptake compared to existing PSMA RLTs may deliver a wider therapeutic window and enable dose intensification to maximize tumor control while preserving patient quality-of-life.

OPTIMAL-PSMA is an open-label, multi-center, randomized, Phase 2 investigator-initiated trial (IIT) led by Professor Louise Emmett at St Vincent’s Hospital in Sydney, Australia. The study is evaluating the safety, dosimetry, and efficacy of an intensified dosing regimen of TLX597-Tx compared with a standard dose schedule in 120 men with advanced mCRPC, randomized on a 2:1 basis. The novel dose-intensification regimen delivers higher activity per cycle (8.5 GBq), delivered on day 1, day 3 and day 15, followed by 10-weekly dosing for three further cycles. The study aims to confirm that a dose intensified TLX597-Tx regimen will maximize the radiation dose to cancerous lesions when they are most vulnerable to damage and therefore improve overall response to treatment.

Telix believes these dosimetry data support further evaluation of TLX597-Tx in earlier-stage disease and is initiating OPTIMAL-E, a Phase 2 study in androgen pathway-sensitive prostate cancer (mHSPC).

Principal Investigator for OPTIMAL-PSMA, Professor Louise Emmett, commented, "The goal of OPTIMAL-PSMA is to identify a dose regimen for TLX597-Tx that leads to deeper and longer responses without increasing toxicity for men with metastatic prostate cancer. We look forward to starting the Phase 2 OPTIMAL-E trial soon."

Dr. David N. Cade, Group Chief Medical Officer at Telix, added, "These encouraging dosimetry results from OPTIMAL-PSMA, combined with earlier exploratory work6, are very promising and highlight TLX597-Tx’s potential to substantially increase the tumor dose while minimizing radiation to sensitive organs. For people living with earlier-stage metastatic disease, preserving quality-of-life alongside effective cancer control is mandatory. These findings support further study in mHSPC and reinforce Telix’s strategy to develop differentiated PSMA-targeting therapies, so clinicians may be able to tailor treatment choice to the patient’s disease stage and individual condition."

TLX597-Tx is being developed alongside TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), Telix’s lead antibody-based prostate cancer therapy candidate, currently the subject of the Phase 3 ProstACT Global7 trial in mCRPC, which is actively dosing patients in jurisdictions with regulatory approval and recently reported data from a safety and dosimetry lead-in8. TLX591-Tx and TLX597-Tx exhibit complementary modes-of-action, suggesting the potential for distinct applications in mCRPC and mHSPC settings as part of Telix’s portfolio approach to treating prostate cancer. TLX591-Tx and TLX597-Tx have not received marketing authorization in any jurisdiction.

(Press release, Telix Pharmaceuticals, APR 29, 2026, View Source [SID1234664920])