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欧盟与美国针对仿制药的免关税安排将推动仿制药发展
Shang Wu Bu Wang Zhan· 2025-08-28 15:33
《爱尔兰观察者报》8月23日报道,周四特朗普政府澄清了欧盟药品出口到美国的原始协议,从欧 洲进口到美国的品牌药最高关税将达到15%,针对仿制药将免征关税。仿制药如今已成为爱尔兰制药业 的重要组成部分,全球最大的两家仿制药制造商梯瓦制药(TEVA)和山德士(Sandoz)集团均在爱尔兰 拥有稳固的根基。仿制药占美国处方药的绝大部分,美国食品药品管理局 (FDA) 估计,仿制药占药品 总销量的91%。仿制药零关税与品牌药15%的关税对爱尔兰制药厂的影响将十分重大。许多品牌制药 商,例如强生和辉瑞,已经建立了生产非品牌或仿制药的工厂,以便在其药品专利保护期结束后生产这 些药品。欧盟与美国的免关税安排必然会加速这一趋势。 对爱尔兰政府而言,欧美协议豁免仿制药关税有助于爱尔兰卫生服务管理局(HSE)削减药品支 出。去年,爱尔兰药品支出约为26亿欧元,是医疗预算中最大的支出项目,而仿制药支出仅为6650亿欧 元。但爱尔兰大型品牌制药企业带来的就业和税收普遍增长,也迫使政府对这些公司给予最大程度的支 持。 (原标题:欧盟与美国针对仿制药的免关税安排将推动仿制药发展) ...
Teva Announces FDA Approval and Launch of Generic Saxenda® (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss
Globenewswire· 2025-08-28 12:30
Generic Saxenda® is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the U.S. market.This approval and launch add to Teva’s continued commitment to its complex generic medicine portfolio as part of its Pivot to Growth Strategy.Liraglutide injection is indicated for adults with obesity or overweight (excess weight) who also have weight related medical problems, and pediatric patients (12-17 years) with a weight greater than 60 kg and obesit ...
TEVA Q2 Earnings Beat, Revenues Miss on Lower Generics Sales
ZACKS· 2025-07-31 17:41
Core Insights - Teva Pharmaceutical Industries reported second-quarter 2025 adjusted earnings of 66 cents per share, exceeding the Zacks Consensus Estimate of 63 cents, with an 8% year-over-year increase in adjusted earnings driven by higher operating profits [1][7] - Revenues for the second quarter were $4.18 billion, falling short of the Zacks Consensus Estimate of $4.28 billion, remaining flat year over year on a reported basis and down 1% on a constant currency basis [1][2] Revenue Performance - Revenue growth was impacted as increased sales from branded drugs such as Austedo, Ajovy, and Uzedy were offset by declining generic drug sales in both U.S. and international markets, primarily due to the exit from Japan [2] - U.S. segment sales reached $2.15 billion, a 2% year-over-year increase, driven by branded drugs, although it missed the Zacks Consensus Estimate of $2.19 billion [3] - Generic/biosimilar product revenues in the U.S. declined 6% year over year to $961 million, missing the Zacks Consensus Estimate of $1.05 billion [4] Branded Drug Sales - Austedo sales in the U.S. were $495 million, up 22% year over year, although it missed the Zacks Consensus Estimate of $501.7 million [9] - Ajovy recorded sales of $63 million, a 53% year-over-year increase, surpassing the Zacks Consensus Estimate of $50.8 million [10] - Uzedy generated sales of $54 million, up 120% year over year, driven by volume growth [10] - Copaxone sales were $62 million, down 23% year over year, but exceeded the Zacks Consensus Estimate of $48.8 million [11] International Market Performance - Europe segment revenues were $1.3 billion, a 7% year-over-year increase, driven by higher revenues from Ajovy and generic products, beating the Zacks Consensus Estimate [12] - International Markets segment sales declined 17% year over year to $495 million, missing the Zacks Consensus Estimate of $602.4 million, primarily due to the divestment in Japan [13][14] Margin and Expense Analysis - Adjusted gross margin was 54.6%, up 170 basis points year over year, attributed to higher Austedo revenues and the sale of certain product rights [15] - Adjusted operating income rose 7% year over year to $1.13 billion, with an adjusted operating margin of 27.1% [17] Guidance Updates - Teva expects total revenues in 2025 to be between $16.8 billion and $17.2 billion, raising guidance for Austedo, Ajovy, and Uzedy sales [18][19] - Adjusted EPS is projected to be in the range of $2.5 to $2.65 per share for 2025, compared to the previous expectation of $2.45 to $2.65 [19]
TEVA(TEVA) - 2025 Q2 - Quarterly Report
2025-07-30 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-16174 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Securities registered pursuant to Section 12(b) of the Act: Trading Title of each class American Depositary Shares, each represen ...
Teva CEO: Our supply chain puts us in a strong position
CNBC Television· 2025-07-30 16:40
Financial Performance - Teva Pharmaceuticals reported an earnings beat in Q2 and raised revenue guidance for the year end [1] - Teva's innovative drugs grew by 27% this quarter [3] - AJOVY grew at 31%, AUSTEDO is up 120%, and AJOVY is up 22% in the US [7] - AUSTEDO is expected to achieve $2 billion in sales this year and is growing at 22% in the US [9] - The company is focused on paying down debt, growing the top line, and increasing profitability to achieve investment grade [11][12] - Earnings per share are up [12] Market Dynamics and Pipeline - Tariffs could put pressure on drug makers and their manufacturing overseas [1] - Approximately 43% of branded drugs sold in the US come from Europe, and about 18% of generics [2] - Teva has limited exposure to tariffs emerging from China and India due to its supply chain [4] - Teva is transforming from a pure play generics player to a biopharma player [13] - Teva plans to file lanzipene with the FDA towards the end of this year, bring a treatment for asthma to market in 2027, and a treatment for oscillitis and Crohn's disease to market in 2028-2029 [15]
Compared to Estimates, Teva Pharmaceutical Industries (TEVA) Q2 Earnings: A Look at Key Metrics
ZACKS· 2025-07-30 14:36
Core Insights - Teva Pharmaceutical Industries Ltd. reported revenue of $4.18 billion for the quarter ended June 2025, reflecting a year-over-year increase of 0.3% but a revenue surprise of -2.47% compared to the Zacks Consensus Estimate of $4.28 billion [1] - The earnings per share (EPS) for the quarter was $0.66, surpassing the consensus estimate of $0.63, resulting in an EPS surprise of +4.76% [1] Financial Performance Metrics - Teva's stock has returned -0.6% over the past month, while the Zacks S&P 500 composite has increased by +3.4% [3] - The company holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3] Geographic Revenue Breakdown - Revenue from Europe was $1.3 billion, exceeding the average estimate of $1.25 billion, with a year-over-year change of +7% [4] - Revenue from International Markets was $495 million, below the average estimate of $602.4 million, representing a year-over-year decline of -16.5% [4] - Revenue from the United States was $2.15 billion, slightly below the estimated $2.19 billion, with a year-over-year increase of +1.9% [4] - Revenue from Anda in the United States was $365 million, surpassing the average estimate of $358.28 million, but showing a year-over-year decline of -2.1% [4] - Revenue from COPAXONE in Europe was $50 million, exceeding the average estimate of $40.5 million, with a year-over-year decline of -5.7% [4] - Revenue from respiratory products in Europe was $55 million, in line with the estimate of $55.07 million, reflecting a year-over-year decrease of -3.5% [4] - Revenue from generic products in International Markets was $410 million, below the average estimate of $478.57 million, with a year-over-year decline of -15.6% [4] - Revenue from COPAXONE in International Markets was $7 million, significantly below the estimate of $10.83 million, representing a year-over-year decline of -50% [4] - Revenue from AJOVY in the United States was $63 million, exceeding the average estimate of $50.8 million, with a year-over-year increase of +50% [4] - Total revenue from COPAXONE was $119 million, above the average estimate of $101.85 million, but showing a year-over-year decline of -19.6% [4] - Total revenue from other sources was $232 million, below the average estimate of $259.03 million, with a year-over-year increase of +118.9% [4] - API sales to third parties amounted to $135 million, below the average estimate of $156.49 million, with a year-over-year decline of -10.6% [4]
TEVA(TEVA) - 2025 Q2 - Earnings Call Transcript
2025-07-30 13:02
Financial Data and Key Metrics Changes - Revenues increased to $4.2 billion, up 1%, marking the tenth consecutive quarter of growth [8][10] - Adjusted EBITDA rose by 7%, and non-GAAP EPS increased by 10% [9] - Net debt to EBITDA ratio is just over 3 times [9][46] Business Line Data and Key Metrics Changes - AUSTEDO revenue reached approximately $495 million, up 22% [13] - ECETI revenue surged by 120% to $54 million [12] - AJOVY revenue grew by 31% to $155 million [12] - Global Generics business declined by 2%, reflecting strong prior year comparisons [21] - TAPI revenue decreased by 11%, attributed to seasonality and timing of shipments [12] Market Data and Key Metrics Changes - U.S. generics business showed a decline due to tough prior year comparisons and timing of shipments [22][24] - EU generics business grew by 8% in the prior year, but growth has slowed due to product launches and competitive stockouts [24] Company Strategy and Development Direction - The company is focused on a "pivot to growth" strategy initiated in 2023, emphasizing innovative products and generics stability [6][27] - A target of $700 million in net savings by 2027 has been set, with 20% of this already achieved [27][40] - The company aims to achieve a 30% operating margin by 2027 [40][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2025 guidance despite uncertainties around U.S. tariffs on pharmaceuticals [41][52] - The innovative portfolio is expected to over-deliver, with raised guidance for AUSTEDO, YEUSEDI, and AJOVY [30][51] - The company anticipates a flat to low single-digit growth in generics for the full year [25][52] Other Important Information - The company has divested its Japanese business, which is consistent with its strategy to focus on profitable growth [42] - Free cash flow grew by 47% to $476 million, driven by higher net income and working capital improvements [45] Q&A Session Summary Question: Insights on AUSTEDO and IRA negotiations - Management refrained from commenting on IRA negotiations due to ongoing discussions with CMS [63][64] Question: Impact of tariffs announced in Europe - Management is assessing the details of the tariffs and believes they have mitigated potential impacts on the business [65][66] Question: AUSTEDO BID to XR conversion timeline - Management indicated that while new patients are converting to XR, it will take time for the majority of patients to transition [72][75] Question: Clarification on tariff impacts and exclusions - Management acknowledged uncertainty regarding the specifics of tariff exclusions and is awaiting further clarity [81][84] Question: Updates on DUVAKITU and Phase II data - Management confirmed that Phase III studies for DUVAKITU are on track and Phase II data will be presented in 2026 [90][91] Question: Revenue guidance related to generic Revlimid - Management clarified that revenue guidance is influenced by the performance of generic Revlimid, particularly in Q4 [103]
TEVA(TEVA) - 2025 Q2 - Earnings Call Transcript
2025-07-30 13:00
Financial Data and Key Metrics Changes - Revenues increased to $4.2 billion, up 1%, marking the tenth consecutive quarter of growth [7][8] - Adjusted EBITDA rose by 7%, and non-GAAP EPS increased by 10% [7][41] - Net debt to EBITDA ratio is just over 3 times [7][44] Business Line Data and Key Metrics Changes - AUSTEDO revenue reached approximately $495 million, up 22% [11] - YUCEDDI revenue increased by 120% to $190 million to $200 million [12] - AJOVY revenue guidance raised to $630 million to $640 million, reflecting a strong 31% growth [16] - Global Generics business declined by 2%, impacted by strong prior year comparisons [10][20] Market Data and Key Metrics Changes - U.S. generics business growth was hindered by prior year comparisons and timing of shipments [21][22] - EU generics business grew by 8% in the prior year, but growth has slowed due to product launches and competitive stockouts [22] Company Strategy and Development Direction - The company is focused on a pivot to growth strategy, emphasizing innovation and a strong pipeline [5][25] - A transformation program aims to generate $700 million in net savings by 2027 [25][46] - The company is transitioning to a biopharma model, with a target of achieving a 30% operating margin by 2027 [37][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2025 guidance despite uncertainties around U.S. tariffs on pharmaceuticals [38][50] - The innovative portfolio is expected to over-deliver, with combined revenue guidance for AUSTEDO, YUCEDDI, and AJOVY raised by approximately $95 million [28][49] - Management remains optimistic about the long-term growth trajectory, driven by innovative products and a stable generics business [55][58] Other Important Information - The company has seen a significant improvement in its balance sheet, with credit rating upgrades from major agencies [37][44] - Free cash flow grew by 47% to $476 million, driven by higher net income and working capital improvements [43] Q&A Session Summary Question: Insights on AUSTEDO and IRA negotiations - Management declined to comment on IRA negotiations due to ongoing discussions with CMS [62][63] Question: Impact of tariffs announced in Europe - Management indicated that they are assessing the details of the tariffs and have prepared mitigation plans [64][66] Question: AUSTEDO's BID to XR conversion - Management noted that while new patients are converting to XR, it will take time for the majority of patients to switch [72][75] Question: Clarification on tariff impacts and generics - Management stated that they do not foresee a meaningful short-term impact from tariffs due to their flexible supply chain [79][80] Question: Updates on DUVAKITU and Phase II data - Management confirmed that the Phase III studies for DUVAKITU are on track and that Phase II data will be presented in 2026 [90][91] Question: Revenue guidance for generic Revlimid - Management acknowledged that revenue guidance is fluid and will depend on the performance of generic Revlimid in the latter half of the year [103]
TEVA(TEVA) - 2025 Q2 - Earnings Call Presentation
2025-07-30 12:00
Financial Performance - Teva's Q2 2025 revenues remained flat at $4176 million compared to Q2 2024, but excluding Japan BV, revenues increased by 2%[87] - Non-GAAP EPS increased by 10% to $066 in Q2 2025 compared to $061 in Q2 2024[87] - Free cash flow increased significantly by 47% to $476 million in Q2 2025 from $324 million in Q2 2024[87] - The company is on track to achieve a 30% operating profit margin (OPM) by 2027 through its transformation program[85, 91] Product Performance - AUSTEDO U S revenues grew by 22% year-over-year to $495 million in Q2 2025[26] - UZEDY revenues increased significantly by 120% year-over-year to $54 million in Q2 2025[22, 31] - AJOVY global revenues increased by 31% year-over-year to $155 million in Q2 2025[22, 34] - Global generics revenues declined by 2%[22], and in local currency, global generics revenues decreased 5% vs Q2'24 including Japan BV[23] Pipeline and Strategy - The company expects to submit olanzapine LAI for U S NDA in Q4 2025[36, 55, 62] - Teva is targeting peak sales of $15-2 billion for the LAI franchise (UZEDY and olanzapine LAI)[102] - The company anticipates the start of Phase 3 trials for duvakitug in ulcerative colitis (UC) and Crohn's disease (CD) by Sanofi in Q4 2025[68] - Teva transformation in '25 well on track to deliver annualized ~20% of total $700 million savings[105]
TEVA(TEVA) - 2025 Q2 - Quarterly Results
2025-07-30 11:06
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. 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 ...