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TEVA Files NDA With FDA for Olanzapine LAI for Schizophrenia
ZACKS· 2025-12-10 15:46
Core Insights - Teva Pharmaceutical Industries Limited has submitted a new drug application (NDA) to the FDA for olanzapine, a long-acting subcutaneous injectable for treating adults with schizophrenia [1][7] - The NDA is backed by phase III SOLARIS study data, demonstrating olanzapine LAI's efficacy, safety, and tolerability in adults aged 18 to 64 with schizophrenia [2][7] - If approved, olanzapine LAI could fill a significant treatment gap for schizophrenia patients, offering a once-monthly formulation [3][9] Teva's Market Performance - Year-to-date, Teva's shares have increased by 29.6%, outperforming the industry average rise of 27.9% [4] - Teva's existing product Uzedy, a long-acting subcutaneous atypical antipsychotic, has contributed significantly to revenue, with sales increasing by 82% year-over-year to $136 million in the first nine months of 2025 [8] Future Revenue Potential - Teva anticipates that its long-acting schizophrenia franchise, including Uzedy and olanzapine LAI, could generate peak sales of $1.5 to $2.0 billion [9] - The company expects to generate over $5 billion in revenues from its branded products by 2030 [12] Branded Drug Pipeline - Teva has seen growth in its branded drugs, with Austedo sales rising by 33% in the first nine months of 2025, and expectations for annual revenues to exceed $2.5 billion by 2027 [10] - The company is also advancing its pipeline with duvakitug, an anti-TL1A therapy for inflammatory bowel diseases, in partnership with Sanofi [11]
Teva Stock Trading Above 200- & 50-Day SMA for 2 Months: How to Play
ZACKS· 2025-12-09 17:16
Core Insights - Teva Pharmaceutical Industries Limited's stock has shown bullish momentum, trading above its 50-day and 200-day simple moving averages since late October, with a golden cross achieved in mid-September, indicating potential for a sustained upward trend [1][2][7] Stock Performance and Drivers - The 50-day SMA remains above the 200-day SMA, signaling positive future gains for the stock [2] - A significant factor contributing to Teva's stock performance was the conclusion of pricing negotiations under the Inflation Reduction Act for its key drug, Austedo, which is set for Medicare price setting starting in 2027. Teva raised its 2025 sales expectations for Austedo and maintains a revenue target of over $2.5 billion by 2027, with projections to exceed $3 billion by 2030 [2][6] Product Performance - Teva's newest branded drugs, including Austedo, Ajovy, and Uzedy, have collectively seen a 33% year-over-year sales increase, reaching $800 million in the third quarter [5] - Austedo sales rose 33% in the first nine months of 2025, with expectations for annual revenues exceeding $2.5 billion by 2027 and over $3 billion by 2030. The launch of Austedo XR, a new formulation, is expected to further boost sales [6] - Ajovy sales increased by 27% in the first nine months of 2025, with anticipated growth from patient expansion and international launches [8] - Uzedy, launched in May 2023, achieved sales of approximately $136 million in the first nine months of 2025, with total sales expected between $190 million and $200 million for the year [9] Pipeline and Future Growth - Teva's branded pipeline includes promising products like olanzapine and duvakitug, with ongoing phase III studies for duvakitug in collaboration with Sanofi [10] - The company anticipates generating over $5 billion in revenues from its branded products by 2030 [11] - Teva's generics and biosimilars pipeline is strengthening, with successful launches of several high-value complex generics and biosimilars [12][13] Market Position and Valuation - Teva's U.S. generics/biosimilars business showed a 15% increase in 2024, although sales were nearly flat in the first nine months of 2025 due to competitive pressures [15] - The stock has risen 28.6% year-to-date, outperforming the industry average of 28.2%, and is trading at a forward price/earnings ratio of 10.39, lower than the industry average of 14.37 [20][23] Financial Outlook - The Zacks Consensus Estimate for earnings has increased from $2.55 to $2.61 per share for 2025, with stability at $2.73 for 2026 [26] - Despite headwinds, Teva's newer drugs are driving top-line growth, and the company is focused on cost savings and margin improvements, targeting an adjusted operating margin of 30% by 2027 [29][30]
TEVA(TEVA) - 2025 FY - Earnings Call Transcript
2025-12-04 16:32
Teva Pharmaceutical Industries (NYSE:TEVA) FY 2025 Conference December 04, 2025 10:30 AM ET Company ParticipantsTraver Davis - Healthcare Sector SpecialistRichard Francis - President and CEOTraver DavisJust continuing on the third and final day of our Citi Global Healthcare Conference. I'm Traver Davis, Healthcare Sector Specialist at Citi, and we're delighted to have Teva with us. From the company, we have Richard Francis, President and CEO. Thanks for joining us. Maybe to start, just hand the floor to you ...
TEVA(TEVA) - 2025 FY - Earnings Call Transcript
2025-12-04 16:30
Financial Data and Key Metrics Changes - The company has transitioned from a generics-focused business to a biopharma company, showing significant progress in financials and business setup over the past three years [2][4] - The gross margin is expected to grow from approximately 48% in Q1 2023 to around 54% by the end of the year, with projections of 57%-58% by 2027 [10][11] Business Line Data and Key Metrics Changes - Austedo, a key product, is projected to exceed $2 billion in sales this year, with peak sales expected to surpass $3 billion [2][17] - The innovative product portfolio has grown by 33% in Q3, contributing significantly to revenue [11] - The company has committed to growing EBITDA despite losing over $1 billion in sales from the generic Revlimid [7][9] Market Data and Key Metrics Changes - The generics business has stabilized and grown over the last three years, despite challenges [4] - The company anticipates a flat or slight decline in top-line revenue due to the loss of Revlimid sales, but is focused on EBITDA growth [9] Company Strategy and Development Direction - The "Pivot to Growth" strategy aims to enhance the innovative product pipeline and increase market share in biopharma [2][4] - The company is focused on maintaining price discipline while ensuring access to its products, emphasizing long-term value creation [21][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $2.5 billion in sales for Austedo by 2027, highlighting the significant untreated market opportunity [23][28] - The company is optimistic about the upcoming product launches, including Olanzapine and Duvakitug, which are expected to drive future growth [36][48] Other Important Information - The company is actively pursuing biosimilars and aims to have a portfolio of 25 biosimilars, with a focus on both the US and European markets [58][59] - Management believes that the removal of phase three trial requirements for biosimilars will serve as a tailwind for growth [56][60] Q&A Session Summary Question: How should we think about 2026 in terms of pushes and pulls? - Management indicated that 2026 is crucial as the company will lose significant sales from generic Revlimid but is committed to growing EBITDA through innovative products and cost-saving programs [7][9] Question: What are the underlying drivers for the $2.5 billion guidance for Austedo? - The company highlighted the large untreated market and the importance of patient education and adherence programs as key drivers for growth [23][25] Question: How does the company plan to maintain price discipline with Uzedy? - Management emphasized the importance of value over access, stating that maintaining price discipline has proven beneficial for the product's market performance [43] Question: What is the potential impact of the label expansion into bipolar for Uzedy? - While the label expansion may not significantly impact peak sales, it enhances the brand's overall perception and could contribute positively to its trajectory [45] Question: What are the expectations for the Duvakitug product? - Management expressed high expectations for Duvakitug, projecting it could become a $3-$5 billion product based on its competitive positioning and multiple indications [48][50] Question: What are the thoughts on capital allocation moving forward? - The company plans to focus capital on innovative products and efficient manufacturing to drive growth and shareholder value [66]
Teva Pharmaceutical Industries (NYSE:TEVA) FY Conference Transcript
2025-12-03 17:02
Summary of Teva Pharmaceutical Industries FY Conference Call Company Overview - **Company**: Teva Pharmaceutical Industries (NYSE: TEVA) - **Date of Conference**: December 03, 2025 Key Industry Insights - **Medicare Part D and IRA Negotiated Discounts**: The recent negotiations regarding Medicare Part D discounts are a significant focus for the company, impacting both Medicare and commercial business segments. The company has modeled the financial implications and finds them manageable, expecting to achieve $2.5 billion in revenue by 2027 based on these discounts [3][4][5]. Core Product Insights Austedo - **Market Opportunity**: There are approximately 800,000 patients with tardive dyskinesia (TD), with only 15% diagnosed and 5-6% receiving treatment. This indicates a substantial growth opportunity for Austedo [4]. - **Growth Expectations**: The company anticipates continued growth in the TD population due to increased utilization of atypical antipsychotics, which will drive demand for Austedo [5][6]. - **Prescription Growth**: In Q3, there was an 11% growth in total prescriptions (TRx) and a 25% growth in milligram sales, attributed to the extended-release (XR) formulation of Austedo [8]. Uzedy - **Performance Metrics**: Uzedy has shown a remarkable 119% year-over-year growth in TRx, primarily attracting patients switching from oral medications [13]. - **Product Advantages**: Uzedy's subcutaneous administration and rapid dosing capabilities make it appealing to both patients and physicians, enhancing its market penetration [15][16]. LAI Olanzapine - **Market Potential**: The company sees significant potential in transitioning patients from oral olanzapine to long-acting injectable (LAI) formulations, with about 20% of oral prescriptions in the U.S. being olanzapine [17]. - **Strategic Positioning**: The company plans to leverage its existing commercial infrastructure to support the launch of LAI olanzapine, enhancing its competitive position in the market [19]. Pipeline Developments Duvakitug - **Phase 3 Trials**: Duvakitug is moving into Phase 3 trials for Crohn's disease and ulcerative colitis, with a focus on patient-centric design and rapid enrollment [22][23]. - **Competitive Edge**: The company claims Duvakitug has the most potent profile among TL1A agents, with low anti-drug antibody rates, positioning it favorably against competitors [27][28]. ICS-SABA Combination Product - **Market Readiness**: The ICS-SABA combination product is expected to complete enrollment by the end of 2026, with results anticipated in early 2027. This product aligns with GINA guidelines, indicating a strong market opportunity [35][36]. Emmer Solman - **Accelerated Pathway Potential**: The ongoing Phase 2 study for Emmer Solman in multiple system atrophy could potentially qualify for accelerated approval if positive results are observed [37]. Additional Considerations - **Disease Awareness Initiatives**: The company emphasizes the importance of increasing awareness among healthcare providers regarding treatable conditions like tardive dyskinesia, which remains underdiagnosed [6][7]. - **Commercial Strategy**: Teva is focused on leveraging insights from existing products to enhance the launch and market penetration of new therapies, ensuring a robust commercial strategy across its CNS portfolio [19]. This summary encapsulates the key points discussed during the conference call, highlighting Teva's strategic focus on product growth, market opportunities, and pipeline developments.
Teva Pharmaceutical Industries (NYSE:TEVA) FY Conference Transcript
2025-12-03 14:22
Teva Pharmaceutical Industries FY Conference Summary Company Overview - **Company**: Teva Pharmaceutical Industries (NYSE: TEVA) - **Date of Conference**: December 03, 2025 Key Points Industry and Product Insights - **Austedo Pricing**: Teva successfully positioned Austedo at the lowest price on the HHS list, which was a strategic decision based on thorough justification and stakeholder engagement [1][2] - **Intellectual Property (IP) Timeline**: The IP for the once-daily formulation of Austedo extends to 2040-2041, while the BID formulation is set to expire in 2033. Teva anticipates a smooth transition to the XR formulation [2] - **Product Pipeline**: By 2033, Teva expects to have multiple products in the market, including Uzedy, olanzapine, Emrysulmin, and Duvakitug, indicating a diversified product portfolio beyond Austedo [2][3] Financial Performance and Projections - **EBITDA Growth**: Teva aims to drive EBITDA growth through innovative products, with expectations of Austedo contributing significantly through the 2030s [3][4] - **2026 Financial Outlook**: Teva anticipates a decline in revenue due to the loss of Revlimid revenue but is committed to growing EBITDA and cash flow in 2026. The innovative portfolio grew by 33% in Q3, contributing over $800 million quarterly [10][11] - **Cost Savings Program**: Teva is on track to achieve two-thirds of its $700 million savings target by the end of 2026, with significant headcount reductions planned [12][13] Product Launches and Market Strategy - **Olanzapine Launch**: Teva is preparing for the launch of long-acting olanzapine, emphasizing the importance of obtaining the right label from the FDA to maximize market potential. The product is expected to generate $1.5-$2 billion in revenue [14][15][20] - **Market Positioning**: Unlike Austedo, which faced a competitive landscape, olanzapine will enter a market with no incumbent brands, presenting a significant opportunity for growth [20][21] Future Growth and Investment Grade Aspirations - **EBITDA Aspirations**: Teva projects that EBITDA could exceed $6 billion, driven by successful product launches and a disciplined approach to operational expenses [26][28] - **Investment Grade Status**: Teva aims to achieve investment-grade status by the second half of next year, supported by diligent debt repayment and EBITDA growth [28][29] Additional Considerations - **Patient Compliance**: Teva's products, including Uzedy and olanzapine, target a significant portion of the schizophrenia patient population, emphasizing the importance of compliance for treatment efficacy [24] - **Securitization and Cash Flow**: Teva's cash flow is projected to reach approximately $2.7 billion by 2027 and over $3 billion by 2030, indicating a strong financial trajectory [32] This summary encapsulates the critical insights from Teva Pharmaceutical Industries' FY conference, highlighting the company's strategic positioning, financial outlook, and product pipeline developments.
Teva Pharmaceutical Industries (NYSE:TEVA) 2025 Conference Transcript
2025-11-18 12:02
Teva Pharmaceutical Industries Conference Summary Company Overview - **Company**: Teva Pharmaceutical Industries (NYSE: TEVA) - **Event**: Jefferies London Healthcare Conference - **Date**: November 18, 2025 Key Points Pivot to Growth Strategy - Teva is in a three-stage pivot to growth strategy: 1. **Return to Growth**: Achieved 11 consecutive quarters of growth 2. **Accelerate Growth**: Focus on innovative business to enhance growth 3. **Maintain Growth**: Currently in this phase with expectations for further advancements based on innovative products and pipeline [3][4][5] Financial Performance and Guidance - Innovative business sales reached over $800 million in Q3, growing by 33% [4] - Key products driving growth include: - **Austedo**: 38% growth - **Uzedy**: 24% growth - **Ajovy**: 19% growth [5] - Anticipated loss of $1 billion in revenue from generic Revlimid in 2026, but EBITDA is expected to grow due to innovative business growth and operational efficiency [9][10] - Organizational effectiveness plan aims to save $700 million by 2027, with two-thirds of savings expected by the end of 2026 [9][10] Innovative Portfolio Highlights - **Austedo**: - 2027 guidance of at least $2.5 billion in sales, with peak sales projected over $3 billion [11][12] - 85% of patients with tardive dyskinesia remain untreated, presenting a significant growth opportunity [15] - **Uzedy**: - Long-acting treatment for schizophrenia, forecasted to generate $200 million this year, with potential franchise sales of $1.5 billion to $2 billion [24][25] - **Olanzapine**: - Long-acting formulation expected to launch in late 2026, with potential for significant market impact [26][32] Pipeline and Future Catalysts - Teva has a robust late-stage pipeline with several upcoming data readouts and product launches: - **Duvakitug**: Targeting multiple indications, partnered with Sanofi for broader market reach [41][42] - **Anti-IL-15**: Expected data readouts in vitiligo and celiac disease [34] - **Emrysoma**: Treatment for MSA with futility analysis upcoming [34] - The company aims for a $5 billion-plus innovative portfolio by 2030 [33] Market Position and Competitive Landscape - Teva emphasizes a disciplined approach to balancing access and value in a competitive market [18][19] - The company is focused on maintaining operational excellence while expanding its innovative portfolio [22] Investor Sentiment - Current investor sentiment may not fully appreciate the value of Teva's pipeline and innovative products, with a call for better recognition of their potential [38][39] Conclusion Teva Pharmaceutical Industries is strategically positioned for growth through its innovative portfolio and operational efficiency. The company is focused on maintaining momentum in its growth trajectory while navigating challenges in the market, particularly with the anticipated loss of revenue from Revlimid. The upcoming product launches and pipeline developments are expected to significantly contribute to Teva's long-term success and shareholder value.
TEVA Q3 Earnings & Revenues Beat, Austedo Sales View Raised, Stock Up
ZACKS· 2025-11-06 17:20
Core Insights - Teva Pharmaceutical Industries reported third-quarter 2025 adjusted earnings of 78 cents per share, exceeding the Zacks Consensus Estimate of 68 cents, with a year-over-year increase of 14% driven by higher operating profits [1][7] - Revenues for the third quarter reached $4.48 billion, surpassing the Zacks Consensus Estimate of $4.35 billion, reflecting a 3% increase from the previous year on a reported basis and a 1% increase on a constant currency basis [1][7] Revenue Breakdown - The top line was supported by strong performance in branded drugs such as Austedo, Ajovy, and Uzedy, alongside increased revenues from generic products in the U.S., including biosimilars, although partially offset by lower revenues in European generics and reduced proceeds from certain product rights [2][5] - U.S. segment sales amounted to $2.48 billion, a 12% year-over-year increase, driven by higher revenues from generic products and the branded drug Austedo, exceeding the Zacks Consensus Estimate of $2.25 billion [5][7] - Generic and biosimilar product revenues in the U.S. rose 7% year over year to $1.18 billion, bolstered by the company's biosimilar portfolio [6][7] Key Product Performance - Austedo sales in the U.S. reached $601 million, up 38% year over year, primarily due to volume growth, and significantly exceeded the Zacks Consensus Estimate of $524 million [7][8] - Ajovy recorded sales of $73 million, a 27% increase year over year, surpassing the Zacks Consensus Estimate of $65 million [8] - Uzedy generated sales of $43 million, up 24% year over year, while Copaxone sales were $62 million, down 9% year over year but still beating the Zacks Consensus Estimate of $41.5 million [9] International Market Performance - The Europe segment reported revenues of $1.24 billion, down 2% year over year, with a 10% decline on a constant currency basis, missing the Zacks Consensus Estimate of $1.30 billion [10] - International Markets segment sales fell 9% year over year to $557 million, with a 10% decrease in constant currency terms, missing the Zacks Consensus Estimate of $593 million [11] Margin and Expense Analysis - Adjusted gross margin for the quarter was 55.3%, an increase of 160 basis points year over year, primarily due to higher Austedo revenues [13] - Adjusted operating income rose 6.6% year over year to $1.29 billion, with an adjusted operating margin of 28.9% [14] Guidance Updates - Teva tightened its total revenue guidance for 2025 to a range of $16.8-$17.0 billion, while raising the guidance for Austedo sales to $2.05-$2.15 billion [15][18] - The company maintained its full-year guidance for Ajovy sales at $630-$640 million and for Uzedy at $190-$200 million [18] - Adjusted EPS guidance for 2025 was raised to a range of $2.55-$2.65 per share [18]
Teva (TEVA) Hits Multi-Year High as Q3 Strengthens FY25 Profitability Expectations
Yahoo Finance· 2025-11-06 17:18
Core Insights - Teva Pharmaceutical Industries Ltd. has shown significant stock performance, reaching a multi-year high and closing up by 20.23% at $24.60 after intra-day trading peaked at $25, driven by strong Q3 results that bolster expectations for a profitable full-year 2025 [1][3]. Financial Performance - The company reported a net income of $460 million in Q3, a remarkable 211% improvement compared to a net loss of $390 million in the same quarter last year [2]. - Revenues increased by 3.4% year-on-year, reaching $4.48 billion, up from $4.33 billion, supported by strong sales growth in its brands: Austedo (up 38%), Ajovy (up 19%), and Uzedy (up 24%) [3]. Revenue Outlook - Teva has adjusted its revenue growth outlook, lowering the upper range to $17 billion from $17.2 billion, while maintaining the lower end at $16.8 billion [4]. - The company expects adjusted EBITDA to be between $4.8 billion and $5 billion, which is an increase from the previous lower end of $4.7 billion [4].
Teva Pharma's Key Branded Drugs Fuel Strong Revenue Growth, Lifts Full-Year Profit Outlook
Benzinga· 2025-11-05 16:30
Financial Performance - Teva Pharmaceutical Industries Ltd. reported total revenue of $4.48 billion for Q3 2025, exceeding analysts' expectations of $4.35 billion [1] - Revenues increased by 3% year-over-year in U.S. dollars, or 1% in local currency [1] - Adjusted earnings were reported at 78 cents per share, surpassing the consensus of 66 cents and up from 69 cents a year ago [4] Key Product Performance - Sales of Austedo, a drug for Huntington's disease, rose by 38% to $618 million, with an increased revenue outlook for 2025 of $2.05 billion to $2.15 billion [2] - Ajovy, a migraine treatment, achieved sales of $168 million, reflecting a 19% increase in local currency year-over-year, with a reaffirmed 2025 revenue outlook of $630 million to $640 million [2] - Uzedy, a schizophrenia drug, generated revenues of $43 million, up 24%, with a reaffirmed 2025 revenue outlook of $190 million to $200 million [3] Guidance and Outlook - Teva raised its fiscal year 2025 adjusted earnings guidance from $2.50-$2.60 per share to $2.55-$2.65, compared to the consensus of $2.58 [5] - The company narrowed its 2025 sales guidance from $16.8 billion-$17.2 billion to $16.8 billion-$17 billion, against a consensus of $16.89 billion [5] Market Position and Stock Performance - Teva's stock increased by 18.23% to $24.19 following the earnings report [6] - The CEO indicated that the company is well-positioned for potential U.S. tariffs, with nine manufacturing plants in operation [6]