On July 30, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported an update on its activities for the quarter ended 30 June 2025 (Q4 FY25) (Press release, Immutep, JUL 30, 2025, View Source [SID1234654646]).

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EFTI DEVELOPMENT PROGRAM IN ONCOLOGY

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC
Immutep’s pivotal TACTI-004 Phase III trial is on track and continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries, with now 78 sites and 23 countries having received regulatory approval, following the successful dosing of the first patient at Calvary Mater Newcastle Hospital in Australia in March 2025.

The TACTI-004 trial evaluates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA and chemotherapy as first line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial with efti will randomize approximately 756 patients at more than 150 clinical sites and trial results will inform a potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology.

In late May, Immutep presented a Trial-in-Progress poster for TACTI-004 at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the United States. We have observed encouraging support from the investigators participating in the study in our meetings to date including those held at ASCO (Free ASCO Whitepaper) 2025, ELCC 2025, and an investigator meeting in Budapest, Hungary. Consistent feedback has been that the efficacy and the safety data collected thus far from the TACTI-002 and INSIGHT-003 trials are impressive and address the unmet medical needs seen by many key opinion leaders.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC
In May, Immutep announced a high 60.8% response rate and 90.2% disease control rate (N=51), according to RECIST1.1, had been achieved in the investigator-initiated INSIGHT-003 trial as of the data cut-off date of 6 May 2025. INSIGHT-003 is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).

In patients with TPS <50% (N=47), who represent a high unmet need and over two-thirds of the 1L NSCLC population, the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8% from KEYTRUDA and chemotherapy.3 Safety continues to be favourable with no new safety signals. Data from this trial are expected to be presented at a medical conference later in CY2025.

HEAD AND NECK CANCER

TACTI-003 (KEYNOTE-C34) Cohort B – Phase IIb Trial in 1L HNSCC with CPS <1
In May, Immutep announced an excellent median Overall Survival (OS) of 17.6 months had been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This part of the Phase II study evaluates efti in combination with KEYTRUDA as first line therapy in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below one (Combined Positive Score [CPS] <1).

The mature 17.6-months median OS in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches in the United States for 1L HNSCC patients with CPS <1 including 10.7-months from cetuximab + chemotherapy and 11.3-months from anti-PD-1 therapy + chemotherapy, as well as 7.9-months from anti-PD-1 monotherapy.1,2

Immutep requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps including potential paths to approval for 1L HNSCC with PD-L1 CPS <1.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
In May, Immutep announced the investigator-initiated EFTISARC-NEO Phase II trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable STS.

The EFTISARC-NEO study is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program.

The trial’s investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present results from the study at a medical meeting later in CY2025.

BREAST CANCER

AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer
Immutep is continuing the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors.

Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA. Patient follow up, data cleaning and analysis is ongoing and an update is anticipated later in CY2025.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial
Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system by enhancing the "brake" function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.

In June, Immutep announced positive initial efficacy data and continued favourable safety data from the first-in-human Phase I study. Through the highest dosing level of IMP761 to date (0.9 mg/kg), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases.

Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg. Additional data from the Phase I is expected to follow later in CY 2025.

INTELLECTUAL PROPERTY
During the quarter, Immutep was granted four new patents. Immutep was granted two new patents for efti in combination with a PD-1 pathway inhibitor by the New Zealand Intellectual Property Office. In addition, two new patents were granted for IMP761, one by the Intellectual Property Office of the Philippines and the other by the Korean Intellectual Property Office.

CORPORATE & FINANCIAL SUMMARY

Senior Management Changes
Immutep’s Acting Chief Medical Officer, Stephan Winckels M.D, Ph.D., has been appointed to the permanent position of Chief Medical Officer. Stephan has over 15 years of experience in oncology drug development and has been working on efti trials as Medical Monitor or Data Monitoring Committee member for more than nine years.

Cash Flow Summary
During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761.

The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 30 June 2025 of approximately A$129.69 million, which is greater than budgeted as at the beginning of FY2025, while progressing our clinical programs within announced timeframes. The total balance consists of: 1) a cash and cash equivalent balance of A$67.41 million and 2) bank term deposits totalling A$62.28 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q4 FY25, cash receipts from customers were A$6k. The net cash used in G&A activities in the quarter was A$1.44 million, compared to A$704k in Q3 FY25. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$307k.

The net cash used in R&D activities during the quarter was A$15.66 million, compared to A$13.6 million in Q3 FY25. The increase is in line with increased clinical trial activities.

Payment for staff costs was A$2.5 million in the quarter, the same as for Q3 FY25. Total net cash outflows used in operating activities in the quarter were A$18.92 million compared to A$16.26 million in Q3 FY25.

Total cash outflows used in investing activities for the quarter was A$8.16 million, mainly due to the net increase of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the company transferred back A$12.92 million from short-term investments that had matured to cash at bank and invested A$21.05 million in short-term investments.

In July, US-based Ridgeback Capital Investments L.P. exercised its last remaining convertible notes and warrants in the Company. The cashless exercise resulted in the issuance of 7,475,208 ordinary shares. The Company is now free of any convertible debt, warrants or options.

On July 30, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its collaboration partner, PeriNess Ltd. ("PeriNess"), has entered into a Clinical Study Agreement (the "Agreement") to support an exploratory clinical study of DNase I in combination with anti-CD19 CAR T cells in patients with large B cell lymphoma (Press release, Xenetic Biosciences, JUL 30, 2025, View Source [SID1234654644]).

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Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the Tel Aviv Sourasky Medical Center ("Sourasky Center"), will act as the principal investigator of the study.

The primary objective of this study is to explore the safety and tolerability of DNase I in combination with anti-CD19 CAR T therapy in subjects with stable or progressive large B-cell lymphoma when DNase I is given in an adjuvant setting. Secondary objectives include efficacy to be evaluated by the measure of complete response rate post CAR T infusion, duration of response and overall survival. The study has the potential for a strong translational component with a complex assessment of biomarker response and analysis of anti-CD19 CAR T expansion and persistence.

"Our data suggests that the degradation of Neutrophil Extracellular Traps (NETs) by DNase I plays a crucial role in maintaining CAR T-cell function and preventing premature CAR T-cell exhaustion. Our preclinical studies conducted show that co-administration of DNase I with anti-CD19 CAR T cells significantly reduce tumor burden, delay tumor relapse and substantially prolong survival compared to the anti-CD19 CAR T cell monotherapy groups in various syngeneic and xenogeneic experimental models of lymphoma and leukemia," stated Alexey Stepanov, PhD, Institute Investigator at the Scripps Research Institute, and a member of Xenetic’s Scientific Steering Committee.

"Progression of large B cell lymphoma (LBCL) is the major obstacle for the success of CAR T therapies, with approximately 40-60% of the patients relapsing in the first year, and 25-35% within 3 months after CAR T infusion, depending on the CAR T product used. While patients with partial or complete response before CAR T infusion have a 1-year progression free survival of 60-80%, those with stable or progressive disease at the time of CAR T infusion have a 1-year progression free survival of 20-30%. NETs facilitate several hallmarks of cancer biology at various stages, including progression, invasion, metastasis, immunosuppression, immune escape, and resistance to therapy. A high content of NETs in lymphoma tissue and blood of patients was associated with a negative outcome. The goal of this clinical study is to improve clinical response by administering DNase I to abrogate the negative effects of NETs on the performance of immune system and CAR T cells," added Dr. Ram.

James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic concluded, "We are pleased with the continued progress of our DNase I program and the expansion of its development in another exploratory study to further evaluate its potential in various oncology indications. We look forward to garnering additional data to realize the full potential of DNase I."

As previously announced, in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator-initiated studies of recombinant DNase I as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.

On July 30, 2025 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported results for the quarter ended June 30, 2025 (Press release, Teva, JUL 30, 2025, View Source [SID1234654643]).

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Mr. Richard Francis, Teva’s President and CEO, said, "Teva’s performance this quarter stands as a testament to the exceptional strength of our innovative portfolio, which remains the primary engine driving our revenue growth. Our key innovative products delivered a 26% increase in local currency, demonstrating their impact on our financial trajectory and value to patients. As we execute our Pivot to Growth strategy, our focus on innovation is unwavering, placing us firmly on track to achieve a 30% operating profit margin by 2027. The rapid advancement of our transformation programs is already unlocking ~$140 million in annual run-rate savings in 2025, a critical milestone toward our overall ~$700 million net savings target by 2027."

Mr. Francis added, "While our relentless commitment to advancing our innovative portfolio now truly sets Teva apart, our generics business continues to provide a stable foundation despite headwinds. The momentum behind our OTC products and biosimilars, together with our current portfolio and pipeline, reinforce our ambition to double biosimilars’ revenues by 2027."

Pivot to Growth Strategy

In Q2 2025, we continued to execute on the four key pillars of our Pivot to Growth strategy, announced in May 2023, and entered into its second phase – "Accelerate Growth." During this phase we expect to focus on growing our innovative portfolio, aligning capital allocation to invest in higher value activities, reinforcing our commitment to patients, and optimizing our organization and operations.

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 ~26% in Q2 2025 YoY in local currency. We raised the 2025 revenue outlook for these products by $95 million at the midpoint: AUSTEDO raised to $2,000 million – $2,050 million, AJOVY raised to $630 million – $640 million and UZEDY raised to $190 million -$200 million. This growth is driven by the strength of the product profiles, continued promotional activities in the U.S., and focused execution by our sales and marketing teams globally.
Stepping Up Innovation – on the second pillar, we continued to accelerate the development of certain key pipeline assets. We anticipate filing olanzapine LAI’s NDA in Q4 2025 and target full enrollment for DARI’s (Dual-action Asthma Rescue Inhaler) Phase 3 trial at the end of 2025, as well the announcement of the start of the Phase 3 Crohn’s disease and ulcerative colitis programs for duvakitug in Q4 2025. Additionally, on June 16, 2025, Teva and Fosun Pharma announced collaboration in Asia for TEV-56278, Teva’s internally-discovered Anti-PD1/IL-2 ATTENUKINE asset, which is expected to accelerate its development, while also freeing up additional resources to accelerate the development of Teva’s key pipeline assets.
Sustaining Our Generics Powerhouse – on the third pillar, we remain focused on strengthening our world-class global generics business with a streamlined portfolio of high-value complex generics and biosimilars; a robust pipeline, as well as an integrated global manufacturing and commercial footprint. In the past few quarters, we achieved several successful launches of biosimilars and other high-value complex generics including octreotide (the generic version of Standostatin LAR Depot), SELARSDITM (ustekinumab-aekn), EPYSQLI (eculizumab-aagh). On July 15, 2025, we also launched fidaxomicin tablets (the generic version of Dificid) in the U.S.
Focusing our Business – Lastly, on the fourth pillar, to accelerate our growth, we are actively transforming our business through portfolio and global manufacturing footprint optimization. On May 7, 2025, we announced the Teva Transformation programs which are expected to generate ~$700 million of net savings through 2027. Under these programs we expect to achieve ~$70 million net savings in 2025, or ~$140 million on a full year run-rate basis, reflecting ~20% of the total programs savings. Our ongoing efforts to allocate capital in a disciplined manner include, among others: debt repayment of ~$1.4 billion at maturity in the first half of 2025 and refinancing of an additional ~$2.3 billion of debt, 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 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 the 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.
Second Quarter 2025 Consolidated Results

Revenues in the second quarter of 2025 were $4,176 million, flat in U.S. dollars, or a decrease of 1% in local currency terms compared to the second quarter of 2024. This decrease was mainly due to a decrease from generic products in our International Markets segment associated with the divestment of our business venture in Japan, as well as in our U.S. segment, and a decrease in revenues from COPAXONE, partially offset by an increase in revenues from our key innovative products. Exchange rate movements during the second quarter of 2025, net of hedging effects, positively impacted revenues by $49 million, compared to the second quarter of 2024.

Exchange rate movements during the second quarter of 2025, net of hedging effects, had a negligible impact on our operating income and non-GAAP operating income compared to the second quarter of 2024.

Gross profit in the second quarter of 2025 was $2,102 million, an increase of 4% compared to $2,024 million in the second quarter of 2024. Gross profit margin was 50.3% in the second quarter of 2025, compared to 48.6% in the second quarter of 2024. Non-GAAP gross profit was $2,278 million in the second quarter of 2025, an increase of 3% compared to $2,205 million in the second quarter of 2024. Non-GAAP gross profit margin was 54.6% in the second quarter of 2025, compared to 52.9% in the second 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, the sale of certain product rights in our Europe Segment, and the divestment of our business venture in Japan, partially offset by lower revenues from COPAXONE.

Research and Development (R&D) expenses, net in the second quarter of 2025 were $244 million, a decrease of 9% compared to $269 million in the second quarter of 2024. Our lower R&D expenses, net in the second quarter of 2025 compared to the second quarter of 2024, were mainly due to a decrease in non-recurring milestone payments related to certain biosimilar projects, and a decrease in our generics projects.

Selling and Marketing (S&M) expenses in the second quarter of 2025 were $654 million, flat compared to the second quarter of 2024.

General and Administrative (G&A) expenses in the second quarter of 2025 were $305 million, an increase of 8% compared to the second quarter of 2024. This increase was mainly due to costs related to optimization activities of our global organization and operations in connection with Teva’s Transformation programs.

Operating Income in the second quarter of 2025 was $455 million, compared to an operating loss of $5 million in the second quarter of 2024. Operating income as a percentage of revenues was 10.9% in the second quarter of 2025, compared to an operating loss as a percentage of revenues of 0.1% in the second quarter of 2024. This increase was mainly due to a goodwill impairment charge recorded in the second quarter of 2024, as well as higher gross profit in the second quarter of 2025, partially offset by higher legal settlements and loss contingencies in the second quarter of 2025. Non-GAAP operating income in the second quarter of 2025 was $1,133 million representing a non-GAAP operating margin of 27.1% compared to non-GAAP operating income of $1,056 million representing a non-GAAP operating margin of 25.3% in the second quarter of 2024. The increase in non-GAAP operating margin in the second quarter of 2025 was mainly due to higher gross profit margin as well as lower operating expenses as a percentage of revenues.

Financial expenses, net in the second quarter of 2025, were $252 million, mainly comprised of net-interest expenses of $203 million. In the second quarter of 2024, financial expenses, net were $241 million, mainly comprised of net-interest expenses of $233 million.

In the second quarter of 2025, we recognized a tax benefit of $78 million, on a pre-tax income of $203 million. In the second quarter of 2024, we recognized a tax expense of $630 million, on a pre-tax loss of $246 million.

Non-GAAP tax rate in the second quarter of 2025 was 16.4%, compared to 15.4% in the second quarter of 2024. Our non-GAAP tax rate in the second quarter of 2025 was mainly affected by releases of uncertain tax positions, foreign exchange impact on deferred tax positions and interest and inflation adjustments related to the agreement with the Israeli Tax Authorities ("ITA"). Our non-GAAP tax rate in the second quarter of 2024 was mainly affected by 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 a 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 second quarter of 2025 were $282 million and $0.24, respectively, compared to net loss attributable to Teva and loss per share of $846 million and $0.75, respectively, in the second quarter of 2024. This change was mainly due to higher income taxes in the second quarter of 2024, as well as higher operating income in the second quarter of 2025, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the second quarter of 2025 were $769 million and $0.66, respectively, compared to $697 million and $0.61, respectively, in the second quarter of 2024.

Adjusted EBITDA was $1,233 million in the second quarter of 2025, an increase of 6%, compared to $1,168 million in the second quarter of 2024.

As of June 30, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,179 million shares and 1,167 million shares, respectively.

Non-GAAP information: non-GAAP adjustments in the second quarter of 2025 were $486 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the second quarter of 2025 were adjusted to exclude the following items:

Amortization of purchased intangible assets of $148 million, of which $138 million is included in cost of sales and the remaining $10 million in S&M expenses;
Impairment of long lived assets of $99 million;
Legal settlements and loss contingencies of $166 million;
Contingent consideration expenses of $19 million;
Equity compensation expenses of $38 million;
Restructuring expenses of $154 million;
Financial expenses of $37 million;
Other non-GAAP items of $53 million;
Corresponding tax effects and unusual tax items of $228 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 generated from operating activities during the second quarter of 2025 was $227 million, compared to $103 million in the second quarter of 2024. The higher cash flow generated from operating activities in the second quarter of 2025 resulted mainly from higher profit in our U.S. segment, and a positive impact from accounts receivables, net of SR&A, mainly due to collection timing, partially offset by higher sequential inventory levels, as well as higher tax payments.

During the second quarter of 2025, we generated free cash flow of $476 million, which we define as comprising $227 million in cash flow generated from operating activities, $336 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $9 million of proceeds from divestitures of businesses and other assets, partially offset by $96 million in cash used for capital investment. During the second quarter of 2024, we generated free cash flow of $324 million, which we define as comprising $103 million in cash flow generated from operating activities, $317 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $1 million in divestitures of businesses and other assets, partially offset by $97 million in cash used for capital investment. The increase in the second quarter of 2025 resulted mainly from higher cash flow generated from operating activities.

As of June 30, 2025, our debt was $17,227 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 $780 million of exchange rate fluctuations. Additionally, during the second quarter of 2025, we repurchased $2,290 million aggregate principal amount of notes upon consummation of a cash tender offer, and issued $2,305 million of senior notes, net of discount and issuance costs. The portion of total debt classified as short-term as of June 30, 2025 was 3% compared to 10% as of December 31, 2024. Our average debt maturity was approximately 5.95 years as of June 30, 2025, compared to 5.5 years as of December 31, 2024.

Segment Results for the Second Quarter of 2025

United States Segment

The following table presents revenues, expenses and profit for our United States segment for the three months ended June 30, 2025 and 2024:

Three months ended June 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 2,151 100% $ 2,110 100%
Cost of sales 901 41.9% 943 44.7%
Gross profit 1,250 58.1% 1,167 55.3%
R&D expenses 152 7.0% 170 8.1%
S&M expenses 279 13.0% 270 12.8%
G&A expenses 113 5.2% 100 4.7%
Other § § (1) §
Segment profit* $ 706 32.8% $ 629 29.8%
* 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 United States segment in the second quarter of 2025 were $2,151 million, an increase of $41 million, or 2%, compared to the second quarter of 2024. This increase was mainly due to higher revenues from our innovative products, mainly AUSTEDO, UZEDY and AJOVY, partially offset by lower revenues from generic products and COPAXONE.

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 June 30, 2025 and 2024:

Three months ended
June 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)

Generic products (including biosimilars) $ 961 $ 1,023 (6%)
AJOVY 63 42 53%
AUSTEDO 495 407 22%
BENDEKA and TREANDA 40 41 (3%)
COPAXONE 62 81 (23%)
UZEDY 54 24 120%
Anda 365 373 (2%)
Other 111 119 (7%)
Total $ 2,151 $ 2,110 2%

Generic products (including biosimilars) revenues in our United States segment in the second quarter of 2025 were $961 million, a decrease of 6% compared to the second quarter of 2024. This decrease was mainly driven by lower revenues from lenalidomide capsules (the generic version of Revlimid) and liraglutide injection 1.8mg (an authorized generic of Victoza), driven primarily by increased competition, 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 second quarter of 2025 were lenalidomide capsules (the generic version of Revlimid), epinephrine injectable solution (the generic equivalent of EpiPen and EpiPen Jr) and Truxima (the biosimilar to Rituxan). In the second quarter of 2025, our total prescriptions were approximately 266 million (based on trailing twelve months), representing 6.9% of total U.S. generic prescriptions, compared to approximately 303 million (based on trailing twelve months), representing 7.9% of total U.S. generic prescriptions in the second quarter of 2024, all according to IQVIA data.

On April 7 2025, Teva and Samsung Bioepis Co., Ltd. announced the availability of, and subsequently launched, EPYSQLI (eculizumab-aagh), a biosimilar to Soliris (eculizumab) in the U.S., for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

AJOVY revenues in our United States segment in the second quarter of 2025 were $63 million, an increase of 53% compared to the second quarter of 2024, mainly due to an increase in sales allowance due to a non-recurring item in the second quarter of 2024 and growth in volume in the second quarter of 2025. In the second quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 31.0% of the subcutaneous injectable anti- CGRP class, compared to 28.6% in the second quarter of 2024.

AUSTEDO revenues in our United States segment in the second quarter of 2025 were $495 million, an increase of 22%, compared to $407 million in the second quarter of 2024. This increase was mainly due to growth in volumes, including the approval of AUSTEDO XR as a one pill, once-daily treatment in 2024.

AUSTEDO XR (deutetrabenazine) extended-release tablets were 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 U.S. 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 second quarter of 2025 were $54 million, an increase of 120% compared to the second quarter of 2024, mainly due to growth in volume.

BENDEKA and TREANDA combined revenues in our United States segment in the second quarter of 2025 were $40 million, a decrease of 3% compared to the second quarter of 2024, mainly due to competition from alternative therapies, as well as from generic bendamustine products.

COPAXONE revenues in our United States segment in the second quarter of 2025 were $62 million, a decrease of 23% compared to the second quarter of 2024, mainly due to market share erosion and competition.

Anda revenues from third-party products in our United States segment in the second quarter of 2025 were $365 million, a decrease of 2%, compared to $373 million in the second 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.

United States Gross Profit

Gross profit from our United States segment in the second quarter of 2025 was $1,250 million, an increase of 7%, compared to $1,167 million in the second quarter of 2024.

Gross profit margin for our United States segment in the second quarter of 2025 increased to 58.1%, compared to 55.3% in the second 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 second quarter of 2025 was $706 million, an increase of 12% compared to $629 million in the second 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 June 30, 2025 and 2024:

Three months ended June 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,298 100% $ 1,213 100%
Cost of sales 581 44.8% 536 44.2%
Gross profit 717 55.2% 677 55.8%
R&D expenses 59 4.6% 62 5.1%
S&M expenses 228 17.5% 209 17.2%
G&A expenses 66 5.1% 64 5.3%
Other § § § §
Segment profit* $ 364 28.0% $ 342 28.2%
* 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 second quarter of 2025 were $1,298 million, an increase of 7%, or $85 million, compared to the second quarter of 2024. In local currency terms, revenues increased by 3% compared to the second quarter of 2024, mainly due to the sale of certain product rights, higher revenues from AJOVY and higher revenues from generic products.

In the second quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $46 million, net of hedging effects, compared to the second quarter of 2024. Revenues in the second quarter of 2025, included $25 million from a negative hedging impact, which is included in "Other" in the table below. Revenues in the second quarter of 2024 included $3 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 June 30, 2025 and 2024:

Three months ended
June 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 1,040 $ 970 7%
AJOVY 71 52 38%
COPAXONE 50 53 (6%)
Respiratory products 55 57 (3%)
Other* 81 81 1%
Total $ 1,298 $ 1,213 7%
*Other revenues in the second quarter of 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our Europe segment in the second quarter of 2025, were $1,040 million, an increase of 7% compared to the second quarter of 2024. In local currency terms, revenues increased by 1%, mainly due to OTC price increases, as well as revenues from recently launched products, partially offset by lower volumes.

AJOVY revenues in our Europe segment in the second quarter of 2025 increased by 38% to $71 million, compared to $52 million in the second quarter of 2024. In local currency terms, revenues increased by 30% due to growth in volume.

COPAXONE revenues in our Europe segment in the second quarter of 2025 were $50 million, a decrease of 6% compared to the second quarter of 2024. In local currency terms revenues decreased by 11%, due to price reductions and a decline in volume resulting from the availability of alternative therapies and competing glatiramer acetate products.

Respiratory products revenues in our Europe segment in the second quarter of 2025 were $55 million, a decrease of 3% compared to the second quarter of 2024. In local currency terms, revenues decreased by 8%, mainly due to net price reductions and lower volumes.

Europe Gross Profit

Gross profit from our Europe segment in the second quarter of 2025 was $717 million, an increase of 6% compared to $677 million in the second quarter of 2024.

Gross profit margin for our Europe segment in the second quarter of 2025 decreased to 55.2%, compared to 55.8% in the second quarter of 2024. This decrease was mainly due to a negative impact from hedging activities, and an unfavorable mix of products, partially offset by the sale of certain product rights.

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 second quarter of 2025 was $364 million, an increase of 6%, compared to $342 million in the second quarter of 2024. This increase was mainly due to higher gross profit, partially offset by higher S&M expenses.

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.

As previously disclosed, on March 31, 2025, we closed the agreement with JKI Co. Ltd., established by the fund managed and operated by private equity firm J-Will Partners Co. Ltd., to sell our Teva-Takeda business venture in Japan, which includes generic and legacy products.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended June 30, 2025 and 2024:

Three months ended June 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 495 100% $ 593 100%
Cost of sales 251 50.8% 307 51.7%
Gross profit 243 49.2% 286 48.3%
R&D expenses 24 4.9% 30 5.1%
S&M expenses 114 23.0% 145 24.5%
G&A expenses 32 6.6% 38 6.4%
Other (1) § § §
Segment profit* $ 74 14.9% $ 73 12.3%
* 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 second quarter of 2025 were $495 million, a decrease of 17% compared to the second quarter of 2024. In local currency terms, revenues decreased by 16% compared to the second quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan.

In the second quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $2 million, including hedging effects, compared to the second quarter of 2024. Revenues in the second quarter of 2025 included $8 million from a negative hedging impact, compared to a negative hedging impact of $5 million in the second quarter of 2024, 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 June 30, 2025 and 2024:

Three months ended
June 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 410 $ 486 (16%)
AJOVY 20 22 (7%)
AUSTEDO 3 12 (76%)
COPAXONE 7 14 (50%)
Other 55 59 (6%)
Total $ 495 $ 593 (17%)

Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $410 million in the second quarter of 2025, a decrease of 16%, in both U.S. dollars and local currency terms compared to the second quarter of 2024, mainly due to the divestment of our business venture 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 second quarter of 2025 were $20 million, compared to $22 million in the second quarter of 2024, mainly due to timing of shipments.

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. In April 2025, AUSTEDO received marketing authorization in South Korea. We continue to pursue additional submissions in various other markets.

AUSTEDO revenues in our International Markets segment in the second quarter of 2025 were $3 million compared to $12 million in the second quarter of 2024. In local currency terms, revenues decreased by 75%, mainly due to timing of shipments.

COPAXONE revenues in our International Markets segment in the second quarter of 2025 were $7 million compared to $14 million in the second quarter of 2024.

International Markets Gross Profit

Gross profit from our International Markets segment in the second quarter of 2025 was $243 million, a decrease of 15% compared to $286 million in the second quarter of 2024.

Gross profit margin for our International Markets segment in the second quarter of 2025 increased to 49.2%, compared to 48.3% in the second quarter of 2024. This increase was primarily due to a favorable mix of products, mainly in connection with the divestment of our business venture 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 second quarter of 2025 was $74 million, an increase of 1%, compared to $73 million in the second quarter of 2024. This increase was mainly due to lower operating expenses, partially offset by a decrease in gross profit, mainly as a result of the divestment of our business venture in Japan.

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 second quarter of 2025 were $232 million, a decrease of 7% in U.S. dollars compared to the second quarter of 2024. In local currency terms, revenues decreased by 9%.

API sales to third parties in the second quarter of 2025 were $135 million, reflecting a decrease of 11% in both U.S. dollars and local currency terms, compared to the second quarter of 2024, mainly due to lower demand and timing of shipments.

Outlook for 2025 Non-GAAP Results

$ billions, except EPS or as noted January 2025 Outlook May 2025 Outlook July 2025 Outlook
Revenues* $16.8 – $17.4 $16.8 – $17.2 $16.8 – $17.2
AUSTEDO ($m)* 1,900-2,050 1,950-2,050 2,000-2,050
AJOVY ($m)* ~600 ~600 630-640
UZEDY ($m)* ~160 ~160 190-200
COPAXONE ($m)* ~370 ~370 ~370
Operating Income 4.1 – 4.6 4.3 – 4.6 4.3 – 4.6
Adjusted EBITDA 4.5 – 5.0 4.7 – 5.0 4.7 – 5.0
Tax Rate 15%-18% 15%-18% 15%-18%
Finance Expenses ~0.9 ~0.9 ~0.9
Diluted EPS ($) 2.35 – 2.65 2.45 – 2.65 2.50 – 2.65
Free Cash Flow** 1.6 – 1.9 1.6 – 1.9 1.6 – 1.9
CAPEX* ~0.5 ~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, July 30, 2025 at 8:00 a.m. ET to discuss its second 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.

On July 30, 2025 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer patients, reported that clinical data from the dose expansion cohort of the Phase 1/2 trial of solnerstotug alone and in combination with Libtayo (cemiplimab), Regeneron’s PD-1 inhibitor, will be presented in a mini oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held October 17-21, 2025 in Berlin, Germany (Press release, Sensei Biotherapeutics, JUL 30, 2025, View Source [SID1234654642]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Presentation Details:

Title: Results from a Phase 1 expansion cohort of solnerstotug (pH-selective anti-VISTA antibody) combined with cemiplimab in patients with advanced solid tumors resistant to prior PD-(L)1 therapy
Presenter: Dr. Kyriakos Papadopoulos, Co-Director of Clinical Research at START, San Antonio
Abstract Number: 3933
Presentation Date & Time: Friday, October 17, 2025 from 2:00 – 3:30 CEST

On July 30, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported the entry into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 928,596 shares of common stock of the Company originally issued in December 2024 and January 2025, having exercise prices between $2.00 and $3.00 per share (Press release, Phio Pharmaceuticals, JUL 30, 2025, View Source [SID1234654641]). Warrants to purchase 100,000 shares of common stock at the existing exercise price of $2.00 per share will be exercised at their existing exercise price of $2.00 per share and warrants to purchase 828,596 shares of common stock will be exercised at a reduced exercise price of $2.485 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statement on Form S-1 (No. 333-284381). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $2.5 million, prior to deducting placement agent fees and offering expenses.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash and the payment of additional $0.125 per new unregistered warrant (additional $232,149 in the aggregate, which are included in the gross proceeds to the Company), the exercising holders will receive new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The new warrants will be exercisable for an aggregate of up to 1,857,192 shares of common stock, at an exercise price of $2.485 per share and will be immediately exercisable upon issuance and (i) will have a term of twenty-four months with respect to new warrants to purchase up to 1,538,596 shares of common stock and (ii) will have a term of five years with respect to new warrants to purchase up to 318,596 shares of common stock, in each case, following the effective date of the resale registration statement registering the shares of common stock issuable upon exercise of the new warrants.

The offering is expected to close on or about July 28, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.