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更新于：2025-07-31
Ustekinumab biosimilar (Alvotech)
乌司奴单抗生物类似药（Alvotech）
更新于：2025-07-31
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Ustekinumab Biosimilar、USTEKINUMAB-AEKN、乌司奴单抗生物类似药 + [5] |
作用方式 抑制剂 |
作用机制 IL-12p40抑制剂(白细胞介素-12β亚基抑制剂)、IL-23抑制剂(白细胞介素-23复合体抑制剂) |
在研适应症 |
非在研适应症- |
原研机构- |
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
Sequence Code 143665H
来源: *****
Sequence Code 143874L
来源: *****
关联
2
项与 乌司奴单抗生物类似药（Alvotech） 相关的临床试验NCT04930042
A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis
开始日期2021-06-03 |
申办/合作机构 |
NCT04744363
Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara® in Healthy Adult Subjects
Protocol Title:
A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects
Short Title:
A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects
Rationale:
Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.
A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects
Short Title:
A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects
Rationale:
Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.
开始日期2021-05-25 |
申办/合作机构 Alvotech Swiss AG [+1] |
100 项与 乌司奴单抗生物类似药（Alvotech） 相关的临床结果
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100 项与 乌司奴单抗生物类似药（Alvotech） 相关的转化医学
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100 项与 乌司奴单抗生物类似药（Alvotech） 相关的专利（医药）
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4
项与 乌司奴单抗生物类似药（Alvotech） 相关的文献（医药）2024-07-01·Clinical Drug Investigation
AVT04: An Ustekinumab Biosimilar
Review
作者: Blair, Hannah A
AVT04 (Uzpruvo®) is a biosimilar of the reference anti-interleukin (IL)-12 and IL-23 monoclonal antibody ustekinumab. It is approved in the EU for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn's disease as per the reference product. AVT04 has similar physicochemical characteristics to those of reference ustekinumab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate to severe chronic plaque psoriasis. AVT04 demonstrated clinical efficacy similar to that of reference ustekinumab in patients with moderate to severe chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT04 were similar to those of reference ustekinumab, and switching from reference ustekinumab to AVT04 had no impact on efficacy, safety or immunogenicity. The role of reference ustekinumab in the management of inflammatory diseases is well established and AVT04 provides an effective biosimilar alternative for patients requiring ustekinumab therapy.
2023-08-03·Expert opinion on biological therapy
Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis
Article
作者: Otto, Hendrik ; Berti, Fausto ; Stroissnig, Heimo ; Feldman, Steven R ; Haliduola, Halimu N ; Duijzings, Paul ; Leutz, Steffen ; Ruffieux, Ruth ; Reznichenko, Nataliya
BACKGROUND:
This study compared efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity between AVT04 and reference product (RP) ustekinumab (Stelara®) in patients with moderate-to-severe chronic plaque psoriasis (PsO).
PATIENTS AND METHODS:
This multicenter, double-blind, 52-week study randomized patients in 1:2 ratio to AVT04 or RP. At week 16, responsive patients (≥50% improvement in psoriasis area and severity index (PASI)) previously on AVT04 continued on AVT04, while those on RP were re-randomized 1:1 to switch to AVT04 or stay on RP. The primary endpoint was a percent improvement in PASI from baseline to week 12. Therapeutic equivalence was demonstrated if the confidence interval (CI) for the adjusted difference in means was contained within the equivalence margins; ±10% (90%CI).
RESULTS:
Of the 581 patients initially randomized (AVT04:RP, 194:387), 575 completed week 16 and 544 completed end of study visit. The percent PASI improvement for AVT04 vs RP was 87.3% vs 86.8% (CI: -2.14%, 3.01%); study met its primary endpoint. Efficacy, safety and PK profiles were comparable across treatment arms throughout the entire study duration, and the incidence of antibodies to ustekinumab had no clinically meaningful impact.
CONCLUSION:
This study demonstrates the therapeutic equivalence between AVT04 and RP in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.
TRIAL REGISTRATION:
NCT04930042; EudraCT Number: 2020-004,493-22.
2023-05-04·Expert opinion on investigational drugs
A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults
Article
作者: Otto, Hendrik ; Hamilton, Paul ; Haliduola, Halimu N ; Wynne, Christopher ; Duijzings, Paul ; McLendon, Kristi ; Smith, Matthew ; Berti, Fausto ; Stroissnig, Heimo ; Sattar, Abid ; Ruffieux, Ruth ; Leutz, Steffen
BACKGROUND:
This study assessed pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT04, a candidate biosimilar, compared with reference product (RP) ustekinumab (EU-approved and US-licensed Stelara®).
METHODS:
Healthy subjects (N = 298) were randomized 1:1:1 to receive one 45 mg dose of AVT04, EU-RP, or US-RP. The primary PK parameters were Cmax and AUC0-inf. PK similarity was demonstrated if the 90% confidence intervals (CI) for the ratio of geometric means were all contained within the prespecified margins of 80% and 125%. Additional PK parameters, including AUC0-t, were also assessed. Safety and immunogenicity were also assessed until Day 92.
RESULTS:
After pre-specified protein content normalization, the 90% CI for the ratio of geometric means for primary PK parameters were all contained within the pre-specified bioequivalence margins of 80% and 125%, supporting demonstration of PK similarity between AVT04 and both EU- and US-RP. Secondary PK parameters supported the analysis. Safety and immunogenicity profiles were comparable across all three treatment arms, although the study was not powered to detect small differences in these parameters.
CONCLUSION:
Results supported a demonstration of PK similarity between candidate biosimilar AVT04, US-RP and EU-RP. Similar safety and immunogenicity were also shown.Clinical trial registration: www.clinicaltrials.gov identifier is NCT04744363.
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项与 乌司奴单抗生物类似药（Alvotech） 相关的新闻（医药）2025-07-30
More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, the company's CFO, Eli Kalif, said Wednesday.
As more drugmakers begin to report second-quarter earnings against the backdrop of the first material pharmaceutical tariff reveal from the Trump administration, Teva Pharmaceuticals isn’t sweating the situation.The Israel-based generics and innovative medicines hybrid has “absorbed the already confirmed tariffs into our 2025 guidance,” Teva’s CFO, Eli Kalif, said on a call with analysts Wednesday.More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, Kalif pointed out. Further, the company has “very limited exposures” in India and China, with Kalif attributing Teva’s lack of reliance on the latter country to the closure of its API business there four years back.“All in all, when we are looking at our supply chain, our ability to actually build inventory and to manage our manufacturing steps, we don’t see here, currently, any meaningful impact for the short term,” Kalif said. The CFO’s comments came after pharmaceutical import tariffs finally surfaced in a new trade deal struck between the U.S. and the European Union (EU) on Sunday. Under the current terms of the deal, the tariff rate stands at 15% for pharmaceutical imports—and those of many other goods—entering the U.S. from Europe.Many unknowns still surround the EU tariffs, including how the U.S.’ Section 232 investigation into the national security implications of pharmaceutical imports could influence the current rate, if at all. Further, in a potentially key carveout for Teva, certain generic drugs will be excluded from the tariffs, though it’s currently unclear which ones.Teva has “done very comprehensive work to understand how we can mitigate the impact [of tariffs] on our business,” the company’s CEO, Richard Francis, said on the call. He cautioned, however, that “there’s a lot of ambiguity about what really occurred with these tariffs,” referring to the 15% duties in the U.S.-EU accord.“I think the way we’ve always played this on tariffs is to be very conservative,” Francis added. “[W]e think about this comprehensively, and probably with a more glass-half-empty approach.”Francis noted that the company has several mitigation plans prepped that Teva can roll out once more details on the Trump administration’s pharmaceutical tariffs become clear.Teva has good reason to want to keep those tariffs from impacting its business as it continues a sales growth rebound and innovative medicines pivot under a multi-year turnaround strategy dubbed “Pivot to Growth.”While Teva is continuing to make good on many different aspects of its plan, the company’s performance in the second quarter was a bit more mixed than it has been in other recent earnings periods.All told, Teva’s revenue grew 1% at constant currencies to $4.2 billion after taking sales from the company’s generics joint venture with Takeda out of the mix. Late last year, Teva and Takeda decided to divest the Japan business to better focus on their own innovative medicine ambitions.When including the Japan JV sales, Teva’s total revenue for the period was flat year over year, according to a company earnings presentation (PDF).Nevertheless, Teva’s focus on its innovative portfolio continues to pay off, with the company now raising its full-year sales guidance for all three of its key marketed meds: Austedo, Uzedy and Ajovy.Teva’s chief drug, Austedo—approved in Huntington’s disease and tardive dyskinesia—grew sales 19% to $498 million for the quarter and is now expected to bring home sales between $2 billion and $2.05 billion for the year, compared to a previous range of $1.95 billion to $2.05 billion.Ajovy for migraine prevention, which delivered second-quarter sales growth of 31% to $155 million, is now pegged to reach sales between $630 million and $640 million, versus a prior projection of roughly $600 million.And Teva’s long-acting risperidone product for schizophrenia, Uzedy, is now in the running to secure $190 million to $200 million in 2025 sales after growing 120% in Q2 to $54 million.Uzedy has fared well in the risperidone and long-acting markets, but Teva now aims to “compete in the broader market of schizophrenia,” Francis said on the call. “So, we’ll be looking for patients to benefit from this on other molecules currently,” he explained.The CEO reiterated that Teva aims to launch the anticipated second half of its long-acting schizophrenia portfolio—long-acting olanzapine—in 2026. Together, the company estimates that the long-acting schizophrenia franchise can deliver combined peak sales of $1.5 billion to $2 billion.The consistent growth of Teva’s innovative drug trio helps affirm the company’s multiyear turnaround thesis, Francis said.When Teva first telegraphed its new growth strategy some two years back, “there was a question mark,” Francis said in an interview following the company’s earnings call. “Can Teva sell innovative drugs? And now we continue to show quarter on quarter we can.” He added that “there’s no secret sauce to this,” explaining that the company is simply hitting on commercialization fundamentals and doing them well. The company’s generics business, meanwhile, fell 2% for the period. Teva called the comparison “flat,” as Francis attributed it to both the timing of shipments of generic Revlimid and a tough comparison to Teva’s second quarter in 2024, when the company benefited from the launch of its Victoza GLP-1 copycat.The company’s biosimilars business, on the other hand, is booming.“We’ve seen some really good sales momentum in the U.S., and that’s been driven by our established brands, as well as our new launches with Selarsdi and generic Soliris that we launched in Q1 this year,” Francis said on Teva's earnings call. Selarsdi is Teva’s biosimilar to Johnson & Johnson’s Stelara.Teva is planning two more biosimilar launches before the year is out. “I think the thing that I’m seeing people take away is the transition from Teva as pure play generics to a biopharma company seemed like it was fiction two years ago,” Francis said in the interview with Fierce.“How could it be done,” he continued. “What we’re seeing now, with our ability to handle a flat generics quarter, because of our innovative growth, shows we’re well on our way to doing that, and I think that’s really exciting.” Editor's note: This story was updated with additional comments from an interview with Teva's CEO at 1:38 pm ET on July 30.
上市批准生物类似药
2025-07-30
On track for 30% operating profit margin by 2027 in line with our Pivot to Growth Strategy.Q2 2025 shows 10th consecutive quarter of year-over-year (YoY) revenue growth; Revenues of $4.2 billion, +1% in local currencyterms (“LC“)excluding Japan BV revenues; United States segment +2%; Europe segment +3% in LC; International Markets segment -4% inLCand excluding Japan BV revenues. Innovative portfolio continues to fuel strong growth and provide value to diverse and critical patient populations: AUSTEDO® – shows continued strong growth with global revenues of $498 million in Q2 2025, +19% in LC compared to Q2 2024; U.S. revenues +22% compared to Q2 2024. Increasing 2025 revenue outlook to $2,000 million - $2,050 million.AJOVY® – global revenues of $155 million in Q2 2025, +31% in LC compared to Q2 2024. Increasing 2025 revenue outlook to $630 million - $640 million.UZEDY® continues to accelerate in 2025 – revenues of $54 million in Q2 2025, +120% compared to Q2 2024. Increasing 2025 revenue outlook to $190 million - $200 million.
Stable generics performance – global generics -2% in LC YoY excluding Japan BV; Generics product revenues -6% in the U.S., +1% in Europe and -1% in International Markets, all in LC and excluding Japan BV revenues, as compared to Q2 2024. Strong biosimilars performance with growth from existing and newly launched products. Expecting two new launches in the second half of 2025. On track to double biosimilar revenues from 2024 to 2027. Teva Transformation programs – combined with innovative product growth - drive our progress towards our 30% operating margin target by 2027. On track to deliver ~$700 million of net savings, expecting achievement of ~$70 million net savings in 2025, or ~$140 million on a full year run-rate basis, reflecting ~20% of the total savings targeted by the programs. Innovative pipeline assets accelerated with submission of U.S. NDA for olanzapine LAI, andduvakitug’s (anti-TL1A) UC and CD program initiations, both expected in Q4 2025.TAPI – Negotiations ongoing; Focused on delivering the best outcome for our shareholders. Q2 2025 Highlights: Revenues of $4.2 billionGAAP diluted EPS of $0.24Non-GAAP diluted EPS of $0.66, an increase of $0.05 or 9% year-over-yearCash flow generated from operating activities of $227 millionFree cash flow of $476 million, an increase of 47% year-over-yearIncrease of 2025 key innovative products revenues and EPS outlook and reaffirms all other outlook components (1)(2): Revenues of $16.8 ‐ $17.2 billion (reaffirmed)Non‐GAAP operating income of $4.3 ‐ $4.6 billion (reaffirmed)Adjusted EBITDA of $4.7 ‐ $5.0 billion (reaffirmed)Non‐GAAP diluted EPS of $2.50 ‐ $2.65 (+$0.05 at the low-end) Free cash flow of $1.6 ‐ $1.9 billion (reaffirmed)
(1) Revised 2025 outlook excludes contribution from the Japan BV after Q1 and continues to include a full year contribution from Teva API, and excludes the expected income from development milestone payments from Sanofi in connection with the Phase 3 ulcerative colitis and Crohn’s disease initiations for duvakitug. (2) This outlook is based on the existing tariff and trade environment as of July 30, 2025, and does not reflect any policy shifts, including pharmaceutical sector tariffs, that could impact our business. TEL AVIV, Israel, July 30, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended June 30, 2025. 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$2,151100% $2,110100%Cost of sales 90141.9% 94344.7%Gross profit 1,25058.1% 1,16755.3%R&D expenses 1527.0% 1708.1%S&M expenses 27913.0% 27012.8%G&A expenses 1135.2% 1004.7%Other §§ (1)§Segment profit*$70632.8% $62929.8%* 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$1,298100% $1,213100%Cost of sales 58144.8% 53644.2%Gross profit 71755.2% 67755.8%R&D expenses 594.6% 625.1%S&M expenses 22817.5% 20917.2%G&A expenses 665.1% 645.3%Other §§ §§Segment profit*$36428.0% $34228.2%* 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$495100% $593100%Cost of sales 25150.8% 30751.7%Gross profit 24349.2% 28648.3%R&D expenses 244.9% 305.1%S&M expenses 11423.0% 14524.5%G&A expenses 326.6% 386.4%Other (1)§ §§Segment profit*$7414.9% $7312.3%* 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 OutlookJuly 2025 OutlookRevenues* $16.8 - $17.4 $16.8 - $17.2$16.8 - $17.2AUSTEDO ($m)* 1,900-2,050 1,950-2,0502,000-2,050AJOVY ($m)* ~600 ~600630-640UZEDY ($m)* ~160 ~160190-200COPAXONE ($m)* ~370 ~370~370Operating Income 4.1 - 4.6 4.3 - 4.64.3 - 4.6Adjusted EBITDA 4.5 - 5.0 4.7 - 5.04.7 - 5.0Tax Rate 15%-18% 15%-18%15%-18%Finance Expenses ~0.9 ~0.9~0.9Diluted EPS ($) 2.35 - 2.65 2.45 - 2.652.50 - 2.65Free Cash Flow** 1.6 – 1.9 1.6 – 1.91.6 – 1.9CAPEX* ~0.5 ~0.5~0.5Foreign 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. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com. Some amounts in this press release may not add up due to rounding. All percentages have been calculated using unrounded amounts. Non-GAAP Financial Measures This press release contains certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("GAAP"). These non-GAAP financial measures, including, but not limited to, non-GAAP operating income, non-GAAP operating margin, non-GAAP gross profit, non-GAAP gross profit margin, Adjusted EBITDA, free cash flow, non-GAAP tax rate, non-GAAP net income (loss) attributable to Teva and non-GAAP diluted EPS, are presented in order to facilitate investors' understanding of our business. We utilize certain non-GAAP financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize the non-GAAP measures: our management and board of directors use the non-GAAP measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management; our annual budgets are prepared on a non-GAAP basis; and senior management’s annual compensation is derived, in part, using these non-GAAP measures. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP measures. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. We are not providing forward looking guidance for GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP measure because we are unable to predict with reasonable certainty the ultimate outcome of certain significant items including, but not limited to, the amortization of purchased intangible assets, legal settlements and loss contingencies, impairment of long-lived assets and goodwill impairment, without unreasonable effort. These items are uncertain, depend on various factors, and could be material to our results computed in accordance with GAAP. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. These forward-looking statements include statements concerning our plans, strategies, objectives, future performance and financial and operating targets, and any other information that is not historical information. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; competition faced by our generic medicines from other pharmaceutical companies and changes in regulatory policy that may result in additional costs and delays; delays in launches of new generic products; our ability to develop and commercialize additional pharmaceutical products; competition for our innovative medicines; our ability to achieve expected results from investments in our product pipeline; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines, and to execute on our organizational transformation and to achieve expected cost savings; and the effectiveness of our patents and other measures to protect our intellectual property rights, including any potential challenges to our Orange Book patent listings in the U.S.;our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all;our business and operations in general, including: the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; effectiveness of our optimization efforts; significant disruptions of information technology systems, including cybersecurity attacks and breaches of our data security; interruptions in our supply chain or problems with internal or third party manufacturing; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism, such as the ongoing conflict between Russia and Ukraine and the state of war declared in Israel; our ability to attract, hire, integrate and retain highly skilled personnel; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets or business units and close or divest plants and facilities, as well as our ability to successfully and cost-effectively consummate such sales and divestitures, including our planned divestiture of our API business;compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; the effects of governmental and civil proceedings and litigation which we are, or in the future become, party to; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage , including as a result of the One Big Beautiful Bill signed into law in the U.S. in July 2025 (“OBBBA”), which is expected to result in stricter Medicaid eligibility requirements and work requirements, which may result in reduced Medicaid enrollment and a resulting decline in coverage for purchases of our medicines, and U.S. Executive Orders issued in April and May 2025 intended to reduce the prices paid by Americans for prescription medicines, including most-favored-nation pricing; increased legal and regulatory action in connection with public concern over the abuse of opioid medications; our ability to timely make payments required under our nationwide opioids settlement agreement and provide our generic version of Narcan® (naloxone hydrochloride nasal spray) in the amounts and at the times required under the terms of such agreement; scrutiny from competition and pricing authorities around the world, including our ability to comply with and operate under our deferred prosecution agreement (“DPA”) with the U.S. Department of Justice (“DOJ”); potential liability for intellectual property right infringement; product liability claims; failure to comply with complex Medicare, Medicaid and other governmental programs reporting and payment obligations; compliance with sanctions and trade control laws; environmental risks; and the impact of ESG issues;the impact of the state of war declared in Israel and the military activity in the Middle East, including the risk of disruptions to our operations and facilities, such as our manufacturing and R&D facilities, located in Israel, the impact of our employees who are military reservists being called to active military duty, and the impact of the war on the economic, social and political stability of Israel;other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our long-lived assets; the impact of geopolitical conflicts including the state of war declared in Israel and the conflict between Russia and Ukraine; potential significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; our exposure to changes in international trade policies, including the imposition of tariffs in the jurisdictions in which we operate, and the effects of such developments on sales of our products and the pricing and availability of our raw materials; and the impact of any future failure to establish and maintain effective internal control over our financial reporting; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Consolidated Statements of Income(U.S. dollars in millions, except share and per share data)(Unaudited)
Three months ended Six months ended June 30, June 30, 2025 2024 2025 2024 Net revenues 4,176 4,164 8,067 7,983 Cost of sales 2,074 2,140 4,088 4,188 Gross profit 2,102 2,024 3,979 3,795 Research and development expenses 244 269 490 511 Selling and marketing expenses 654 656 1,276 1,265 General and administrative expenses 305 283 603 561 Intangible assets impairments 42 61 163 141 Goodwill impairment - 400 - 400 Other asset impairments, restructuring and other items 232 280 210 954 Legal settlements and loss contingencies 166 83 252 188 Other loss (income) 4 (2) 9 (1) Operating income (loss) 455 (5) 975 (223) Financial expenses, net 252 241 477 491 Income (loss) before income taxes 203 (246) 497 (713) Income taxes (benefit) (78) 630 (4) 578 Share in (profits) losses of associated companies, net (1) (2) (1) 2 Net income (loss) 283 (874) 503 (1,294) Net income (loss) attributable to redeemable and non-redeemable non-controlling interests § (29) 6 (309) Net income (loss) attributable to Teva 282 (846) 497 (985)
Earnings (loss) per share attributable to Teva:Basic ($)0.25 (0.75) 0.43 (0.87) Diluted ($)0.24 (0.75) 0.43 (0.87) Weighted average number of shares (in millions):Basic1,147 1,133 1,142 1,128 Diluted1,161 1,133 1,159 1,128
Non-GAAP net income attributable to Teva for diluted earnings per share:* 769 697 1,371 1,245
Non-GAAP earnings per share attributable to Teva:*Diluted ($)0.66 0.61 1.18 1.09
Non-GAAP average number of shares (in millions):Diluted1,161 1,151 1,159 1,146
Amounts may not add up due to rounding.
§ Represents an amount less than $0.5 million.
* See reconciliation attached.
CONSOLIDATED BALANCE SHEETS (U.S. dollars in millions, except for share data) (Unaudited)
June 30, December 31,
2025 2024 ASSETS
Current assets:
Cash and cash equivalents $2,161 $3,300 Accounts receivables, net of allowance for credit losses of $84 million and $78 million as of June 30, 2025 and December 31, 2024, respectively. 3,564 3,059 Inventories 3,497 3,007 Prepaid expenses 1,084 1,006 Other current assets 472 409 Assets held for sale 1,842 1,771 Total current assets 12,620 12,552 Deferred income taxes 1,781 1,799 Other non-current assets 470 462 Property, plant and equipment, net 4,810 4,581 Operating lease right-of-use assets, net 358 367 Identifiable intangible assets, net 4,142 4,418 Goodwill 15,949 15,147 Total assets $40,131 $39,326
LIABILITIES AND EQUITY
Current liabilities:
Short-term debt $464 $1,781 Sales reserves and allowances 4,050 3,678 Accounts payables 2,498 2,203 Employee-related obligations 481 624 Accrued expenses 3,095 2,792 Other current liabilities 940 1,020 Liabilities held for sale 334 698 Total current liabilities 11,861 12,796
Long-term liabilities:
Deferred income taxes 440 483 Other taxes and long-term liabilities 3,938 4,028 Senior notes and loans 16,763 16,002 Operating lease liabilities 296 296 Total long-term liabilities 21,436 20,809 Redeemable non-controlling interests — 340
Equity:
Teva shareholders’ equity: 6,827 5,373 Non-controlling interests 7 7 Total equity 6,834 5,380 Total liabilities and equity $40,131 $39,326
Amounts may not add up due to rounding.
TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. dollars in millions) (Unaudited)
Three months ended Six months ended June 30, June 30, 2025 2024 2025 2024 Operating activities:
Net income (loss)$
283
(874) $
503
(1,294) Adjustments to reconcile net income (loss) to net cash provided by operations:
Depreciation and amortization
251
259
494
531 Impairment of goodwill
-
400
-
400 Impairment of long-lived assets and assets held for sale
99
130
177
809 Net change in operating assets and liabilities
(336)
(10)
(1,035)
(507) Deferred income taxes – net and uncertain tax positions
(211)
(424)
(183)
(613) Stock-based compensation
38
32
72
60 Other items*
105
592
94
594 Net loss (gain) from sale of business and long-lived assets
(2)
(1)
-
(1) Net cash provided by (used in) operating activities
227
103
122
(21)
Investing activities:
Beneficial interest collected in exchange for securitized trade receivables
336
317
658
612 Purchases of property, plant and equipment and intangible assets
(96)
(97)
(223)
(221) Proceeds from sale of business and long-lived assets, net
9
1
26
1 Acquisition of businesses, net of cash acquired - - - (15) Purchases of investments and other assets
(16)
(43)
(27)
(55) Other investing activities
3
-
3
- Net cash provided by (used in) investing activities
236
178
437
322
Financing activities:
Repayment of senior notes and loans and other long-term liabilities (2,300)
(956)
(3,668)
(956) Proceeds from senior notes, net of issuance costs
2,305
-
2,305
- Purchase of shares from redeemable and non-redeemable non-controlling interests
-
-
(38)
(64) Dividends paid to redeemable and non-redeemable non-controlling interests
-
-
(340)
(78) Other financing activities
1
(10)
3
(19) Net cash provided by (used in) financing activities
6
(966)
(1,738)
(1,117)
Translation adjustment on cash and cash equivalents
(5)
(49)
40
(153)
Net change in cash and cash equivalents
464
(733)
(1,139)
(969) Balance of cash, cash equivalents at beginning of period
1,697
2,991
3,300
3,227
Balance of cash, cash equivalents at end of period$
2,161
2,258 $ 2,161
2,258
Non-cash financing and investing activities:
Beneficial interest obtained in exchange for securitized accounts receivables$
329
320 $
641
632
*Adjustment in the three months period ended June 30, 2024 was mainly related to an agreement with the Israeli Tax Authorities.
Amounts may not add up due to rounding. The accompanying notes are an integral part of the financial statements.
Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva
Three months ended Six months ended
June 30, June 30, ($ in millions except per share amounts) 2025 2024 2025 2024 Net income (Loss) attributable to Teva($)282 (846) ($)497 (985) Increase (decrease) for excluded items:
Amortization of purchased intangible assets 148 146 292 298 Legal settlements and loss contingencies(1) 166 83 249 188 Goodwill impairment(2) - 400 - 400 Impairment of long-lived assets(3) 99 130 177 809 Restructuring costs(4) 154 18 168 31 Equity compensation 38 32 72 60 Contingent consideration(5) 19 192 30 271 Accelerated depreciation - - - 7 Financial expenses 37 12 51 24 Redeemable and non-redeemable non-controlling interests(6) - (33) 2 (317) Other non-GAAP items(7) 53 59 116 106 Corresponding tax effects and unusual tax items(8) (228)503 ($)(283)353 Non-GAAP net income attributable to Teva($)769 697 1,371 1,245 Non-GAAP tax rate(9) 16.4% 15.4% ($)16.9% 15.2% GAAP diluted earnings (loss) per share attributable to Teva($)0.24 (0.75) 0.43 (0.87) EPS difference(10) 0.42 1.35 ($)0.75 1.96 Non-GAAP diluted EPS attributable to Teva(10)($)0.66 0.61 1.18 1.09 Non-GAAP average number of shares (in millions)(10) 1,161 1,151 1,159 1,146
(1)For the three and six months ended June 30, 2025, adjustments of legal settlements and loss contingencies mainly consisted of (a) an update to the estimated settlement provision for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments) in the amount of $47 million and $97 million, respectively (b) an update to the estimated provision recorded for the claims brought by attorneys general representing states and territories throughout the United States in the generic drug antitrust litigation in the amount of $55 million. (2)A goodwill impairment charge of $400 million related to our Teva’s API reporting unit was recognized in the three and six months ended June 30, 2024. (3)For the three months ended June 30, 2025, the adjustment for impairment of long-lived assets consisted of (a) impairment of long-lived assets of $42 million mainly related to products in the U.S. and Europe, and (b) $55 million related to the held for sale measurement of the API business (including its R&D, manufacturing and commercial activities), which includes a favorable impact related to the expected gain from the reclassification of currency translation adjustments. For the six months ended June 30, 2025, the adjustment for impairment of long-lived assets was mainly related to products in the U.S. and Europe. For the six months ended June 30, 2024, adjustments for impairment of long-lived assets primarily consisted of $644 million related to the classification of our business venture in Japan as held for sale. (4)In the three and six months ended June 30, 2025, Teva recorded $154 million and $168 million, respectively, of restructuring expenses primarily related to optimization activities in connection with Teva's Transformation programs related to Teva’s global organization and operations mainly through headcount reduction. (5)In the three and six months ended June 30, 2024, adjustments for contingent consideration primarily related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (the generic version of Revlimid®), of $174 million and $238 million, respectively. (6)For the six months ended June 30, 2024, the adjustment is related to non-controlling interests portion of long-lived assets impairment of $644 million related to the classification of our business venture in Japan as held for sale. (7)Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, accelerated depreciation, certain inventory write-offs, material litigation fees and other unusual events. (8)Adjustments for corresponding tax effects and unusual tax items exclusively consisted of the tax impact directly attributable to the pre-tax items that are excluded from non-GAAP net income included in the other adjustments to this table. For the three months ended June 30, 2024, adjustments of $503 million mainly related to the settlement agreement with the ITA to settle certain litigation with respect to taxes payable for the Company’s taxable years 2008 through 2020, in an amount of $495 million. (9)Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above. (10)EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares.
Reconciliation of gross profit to Non-GAAP gross profit (Unaudited)
Three months ended Six months ended
June 30, June 30, ($ in millions) 2025 2024 2025 2024 Gross profit$2,102 2,024 $3,979 3,795 Gross profit margin 50.3%48.6% 49.3%47.5% Increase (decrease) for excluded items: (1)
Amortization of purchased intangible assets 138 136 273 273 Equity compensation 6 7 12 13 Other non-GAAP items 32 37 69 87 Non-GAAP gross profit$2,278 2,205 $4,332 4,168 Non-GAAP gross profit margin (2) 54.6%52.9% 53.7%52.2%
(1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table. (2) Non-GAAP gross profit margin is non-GAAP gross profit as a percentage of revenue.
Reconciliation of operating income (loss) to Non-GAAP operating income (loss) (Unaudited)
Three months ended Six months ended
June 30, June 30, ($ in millions) 2025 2024 2025 2024 Operating income (loss)($)455 (5) ($)975 (223) Operating margin 10.9%(0.1%) 12.1%(2.8%) Increase (decrease) for excluded items: (1)
Amortization of purchased intangible assets 148 146 292 298 Legal settlements and loss contingencies 166 83 249 188 Goodwill impairment - 400 - 400 Impairment of long-lived assets 99 130 177 809 Restructuring costs 154 18 168 31 Equity compensation 38 32 72 60 Contingent consideration 19 192 30 271 Loss (gain) on sale of business - - 13 § Other non-GAAP items 53 59 103 113 Non-GAAP operating income (loss)($)1,133 1,056 ($)2,079 1,948 Non-GAAP operating margin(2) 27.1%25.3% 25.8%24.4%
§ Represents an amount less than $0.5 million. (1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table. (2) Non-GAAP operating margin is Non-GAAP operating income as a percentage of revenues.
Reconciliation of net income (loss) to adjusted EBITDA (Unaudited) Three months ended Six months ended June 30, June 30, ($ in millions) 2025 2024 2025 2024 Net income (loss) $283 (874) $503 (1,294) Increase (decrease) for excluded items:(1)
Financial expenses 252 241 477 491 Income taxes (78)630 (4)578 Share in profits (losses) of associated companies –net(1)(2) (1)2 Depreciation 103 113 201 233 Amortization 148 146 292 298 EBITDA 705 254 1,468 308 Legal settlements and loss contingencies166 83 249 188 Goodwill impairment - 400 - 400 Impairment of long lived assets 99 130 177 809 Restructuring costs 154 18 168 31 Equity compensation 38 32 72 60 Contingent consideration 19 192 30 271 Other non-GAAP items 50 59 110 106 Adjusted EBITDA$1,233 1,168 2,274 2,173
(1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table.
Segment Information (Unaudited)
United States Europe International Markets Three months ended June 30, Three months ended June 30, Three months ended June 30, 2025 2024 2025 2024 2025 2024
(U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions)
Revenues$2,151 $2,110 $1,298 $1,213 $495 $593Cost of sales 901 943 581 536 251 307Gross profit 1,250 1,167 717 677 243 286R&D expenses 152 170 59 62 24 30S&M expenses 279 270 228 209 114 145G&A expenses 113 100 66 64 32 38Other § (1) § § (1) §Segment profit$706 $629 $364 $342 $74 $73
§ Represents an amount less than $0.5 million.
Segment Information Unaudited
United States Europe International Markets Six months ended June 30, Six months ended June 30, Six months ended June 30, 2025 2024 2025 2024 2025 2024
(U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions)
Revenues$4,060 $3,835 $2,492 $2,485 $1,077 $1,190 Cost of sales 1,752 1,809 1,117 1,070 556 607 Gross profit 2,308 2,025 1,374 1,415 521 583 R&D expenses 306 324 120 118 49 58 S&M expenses 552 530 427 403 232 263 G&A expenses 208 193 135 130 72 73 Other income 3 (1) § § (2) (1)Segment profit$1,239 $979 $693 $764 $171 $190
§ Represents an amount less than $0.5 million.
Reconciliation of our segment profit to consolidated income (loss) before income taxes
Three months ended June 30,
2025 2024
(U.S.$ in millions)
United States profit $706 $629 Europe profit 364 342 International Markets profit 74 73 Total reportable segment profit 1,144 1,043 Profit (loss) of other activities (11) 12 Total segment profit 1,133 1,056 Amounts not allocated to segments:
Amortization 148 146 Other asset impairments, restructuring and other items 232 280 Goodwill impairment - 400 Intangible asset impairments 42 61 Legal settlements and loss contingencies 166 83 Other unallocated amounts 91 91 Consolidated operating income (loss) 455 (5) Financial expenses - net 252 241 Consolidated income (loss) before income taxes $203 $(246)
Reconciliation of our segment profit to consolidated income (loss) before income taxes
Six months ended June 30, 2025 2024
(U.S.$ in millions)
United States profit $1,239 $979 Europe profit 693 764 International Markets profit 171 190 Total reportable segment profit 2,102 1,933 Profit (loss) of other activities (23) 15 Total segment profit 2,079 1,948 Amounts not allocated to segments:
Amortization 292 298 Other asset impairments, restructuring and other items210 954 Goodwill impairment - 400 Intangible asset impairments 163 141 Legal settlements and loss contingencies 249 188 Other unallocated amounts 190 190 Consolidated operating income (loss) 975 (223) Financial expenses - net 477 491 Consolidated income (loss) before income taxes $497 $(713)
Segment revenues by major products and activities(Unaudited)
Three months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) United States segment
Generic products (including biosimilars) $961 $1,023 (6%)AJOVY 63 42 53%AUSTEDO 495 407 22%BENDEKA and TREANDA 40 41 (3%)COPAXONE 62 81 (23%)UZEDY 54 24 120%Anda 365 373 (2%)Other 111 119 (7%)Total 2,151 2,110 2%
Three months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) Europe segment
Generic products (including OTC and biosimilars) $1,040 $970 7%AJOVY 71 52 38%COPAXONE 50 53 (6%)Respiratory products 55 57 (3%)Other* 81 81 1%Total 1,298 1,213 7%
*Other revenues in the second quarter of 2025 include the sale of certain product rights.
Three months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) International Markets segment
Generic products (including OTC and biosimilars) $410 $486 (16%)AJOVY 20 22 (7%)AUSTEDO 3 12 (76%)COPAXONE 7 14 (50%)Other* 55 59 (6%)Total 495 593 (17%)
Segment revenues by major products and activities(Unaudited)
Six months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) United States segment
Generic products $1,809 $1,831 (1%)AJOVY 117 87 34%AUSTEDO 891 689 29%BENDEKA / TREANDA 76 87 (12%)COPAXONE 116 111 5%UZEDY 93 40 134%Anda 738 754 (2%)Other 220 237 (7%)Total 4,060 3,835 6%
Six months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) Europe segment
Generic products $2,029 $1,974 3%AJOVY 129 102 26%COPAXONE 92 110 (17%)Respiratory products 110 123 (11%)Other* 132 175 (25%)Total 2,492 2,485 0%
*Other revenues in the first six months of 2025 include the sale of certain product rights.
Six months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) International Markets segment
Generic products $878 $963 (9%)AJOVY 48 39 25%AUSTEDO 18 26 (33%)COPAXONE 17 25 (32%)Other* 116 136 (15%)Total 1,077 1,190 (9%)
*Other revenues in the first six months of 2025 include the sale of certain product rights.
Free cash flow reconciliation (Unaudited)
Three months ended June 30, 2025 2024
(U.S. $ in millions)
Net cash provided by (used in) operating activities 227 103 Beneficial interest collected in exchange for securitized accounts receivables 336 317 Capital investment (96) (97)Proceeds from divestitures of businesses and other assets, net 9 1 Free cash flow$476 $324
Free cash flow reconciliation (Unaudited)
Six months ended June 30, 2025 2024
(U.S. $ in millions)
Net cash provided by (used in) operating activities 122 (21)Beneficial interest collected in exchange for securitized trade receivables 658 612 Capital investment (223) (221)Proceeds from divestitures of businesses and other assets, net 26 1 Acquisition of businesses, net of cash acquired - (15) Free cash flow$583 $356
Teva Media Inquiries TevaCommunicationsNorthAmerica@tevapharm.com Teva Investor Relations Inquires TevaIR@Tevapharm.com A PDF accompanying this announcement is available at http://ml-eu.globenewswire.com/Resource/Download/626fd803-b4ed-4646-b41e-cf6b0e93ecff
临床3期财报生物类似药上市批准
2025-07-09
REYKJAVIK, Iceland and BURGDORF, Switzerland, July 09, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the expansion of its capacity for assembly and packaging with the acquisition of Ivers-Lee Group (“Ivers-Lee”), a family owned business with headquarters in Burgdorf, Switzerland specializing in providing high-quality assembly and packaging services for the pharmaceutical sector. While Ivers-Lee will remain a separate legal entity, its operations will be integrated into Alvotech’s Technical Operations division, supporting Alvotech’s ambitious plans for growth.
“Ivers-Lee has been an Alvotech preferred partner in assembly and packaging for several years. We know and trust each other very well, having worked closely together. As Alvotech prepares for the launch of three new biosimilars in 2025 and sales growth in global markets, the integration of Ivers-Lee into our Technical Operations, provides added flexibility and capacity to meet increased global demand for our biosimilars, maintaining the highest level of quality and service,” said Robert Wessman, founder, chairman and CEO of Alvotech.
Ivers-Lee was founded in Burgdorf, Switzerland in 1947, to supply innovative packaging services for the pharmaceutical sector. In addition to the site in Burgdorf, Ivers-Lee also operates a strategic business unit in Lörrach, Germany.
Managing director Peter Schüpbach, grandson of Ivers-Lee’s founder, will remain managing director and member of the Board of Directors of Ivers-Lee Group. Furthermore, he will join the Technical Operations senior leadership team of Alvotech following the acquisition.
“Alvotech offers the Ivers-Lee Group financial strength and development opportunities in a growth market, that we as a founding family cannot offer. This change brings stability both for Ivers-Lee and its employees,” said Peter Schüpbach.
Ivers-Lee’s site in Burgdorf is GMP licensed, and FDA approved. Among the capabilities that will be integrated with Alvotech’s operations are assembly and packaging of autoinjectors, pre-filled syringes and safety devices and packaging of vials. Ivers-Lee has an international customer base and will also continue servicing other existing clients and providing CMO services, including blister and stick-pack activities as well as clinical supplies and QP services, provided by the unit in Lörrach.
About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.
Alvotech Forward-Looking StatementsCertain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to successfully integrate the operations of its subsidiaries with its core operations, including Ivers Lee; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.
ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONSBenedikt Stefansson, VPalvotech.ir@alvotech.com
SWISS MEDIA CONTACTPeter Schüpbach, MD Ivers-Leep.schuepbach@iverslee.com
并购上市批准生物类似药
100 项与 乌司奴单抗生物类似药（Alvotech） 相关的药物交易
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| 活动性重度克罗恩病 | 挪威 | 2024-01-05 | |
| 克罗恩病 | 加拿大 | 2023-11-01 | |
| 银屑病关节炎 | 日本 | 2023-09-25 | |
| 斑块状银屑病 | 日本 | 2023-09-25 |
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临床结果
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适应症
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 927 | Ustekinumab 45 mg (PsA STUDY 1) | 鹹鑰網築衊選網鬱餘餘(夢鹹觸壓艱繭鏇夢齋構) = 構淵築蓋餘醖廠簾網窪 簾窪顧鬱鬱願鏇構衊顧 (觸鹽築壓艱範壓壓艱蓋 ) 更多 | 积极 | 2024-04-16 | ||
Ustekinumab90 mg (PsA STUDY 1) | 鹹鑰網築衊選網鬱餘餘(夢鹹觸壓艱繭鏇夢齋構) = 築壓鏇衊製醖艱醖構遞 簾窪顧鬱鬱願鏇構衊顧 (觸鹽築壓艱範壓壓艱蓋 ) 更多 | ||||||
临床3期 | 2,069 | Placebo (Ps STUDY 1 + Adult) | 願糧鏇選鏇膚淵繭壓願(鑰膚鏇獵願齋鹹鑰顧範) = 夢膚壓廠壓繭鏇齋鏇衊 壓積獵網鏇蓋糧鏇鹽膚 (鏇繭憲鑰製膚膚觸製淵 ) 更多 | 积极 | 2024-04-16 | ||
Ustekinumab 45 mg (Ps STUDY 1 + Adult) | 願糧鏇選鏇膚淵繭壓願(鑰膚鏇獵願齋鹹鑰顧範) = 鑰製製窪積鹽遞積蓋構 壓積獵網鏇蓋糧鏇鹽膚 (鏇繭憲鑰製膚膚觸製淵 ) 更多 | ||||||
临床3期 | 581 | 鑰觸網艱壓顧窪簾鹽糧(壓衊構壓餘範糧醖蓋淵) = 蓋廠願鏇觸壓壓衊築鏇 網艱構糧觸膚鑰鬱膚獵 (網鑰顧鹽餘築簾憲鹹鬱 ) | 积极 | 2023-07-12 | |||
Reference product ustekinumab (Stelara®) | 鑰觸網艱壓顧窪簾鹽糧(壓衊構壓餘範糧醖蓋淵) = 艱網構鬱膚範蓋齋夢顧 網艱構糧觸膚鑰鬱膚獵 (網鑰顧鹽餘築簾憲鹹鬱 ) | ||||||
临床3期 | 581 | 壓鑰壓壓願網淵醖選繭(繭構鹹鹽壓鬱觸積醖齋) = 淵鏇觸鑰艱願顧壓鹹網 製顧醖簾襯願廠選糧餘 (蓋構壓壓餘醖獵積願窪 ) 更多 | - | 2023-03-17 | |||
Reference Ustekinumab | 壓鑰壓壓願網淵醖選繭(繭構鹹鹽壓鬱觸積醖齋) = 餘遞獵廠窪遞築築鏇遞 製顧醖簾襯願廠選糧餘 (蓋構壓壓餘醖獵積願窪 ) 更多 |
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