Summary of Organon Conference Call Company Overview - **Company**: Organon - **Event**: 37th Annual Piper Sandler Healthcare Conference - **Speakers**: Joe Morrissey (Interim CEO), Matt Walsh (CFO) Key Points Internal Investigation and Remediation - An internal investigation focused on sales practices related to Nexplanon and two wholesalers was concluded, identifying a weakness in the "tone at the top" [2][3] - A detailed remediation plan has been approved by the audit committee, emphasizing ethics training and mechanisms for employees to escalate concerns [2][3] - The investigation found that revenue management around quarter-end orders affected less than 1% of annual revenue and 2% in any quarter, confirming that revenue recognition practices were appropriate [3][5] Financial Performance and Cost Discipline - In 2025, Organon achieved a reduction of $200 million in operating expenses, with continued cost discipline expected in 2026 [11][14] - The adjusted EBITDA margin target of 31% for 2026 is considered challenging due to flattening Nexplanon sales and ongoing investments in Vtama [14][18] Research and Development (R&D) Strategy - The primary R&D focus is on maximizing the value of existing products, including Vtama, while deprioritizing larger, longer-term programs [21][28] - Organon aims to evolve into a more commercially focused organization, potentially leading to significant cuts in the R&D budget [28][30] Nexplanon Product Outlook - Nexplanon is expected to face flat to declining sales in the U.S. due to Title X funding challenges and policy changes affecting Planned Parenthood [39][44] - Internationally, Nexplanon continues to grow, with recent reimbursement wins in Brazil [53][41] - The product lost exclusivity in Europe, but generics have not yet entered the market [44][46] Vtama Sales Performance - Vtama's 2025 sales guidance was lowered due to challenges in volume growth and gross-to-net moderation, with access improving from less than 40% to around 70%-80% in preferred tiers [75][80] - The competitive landscape for topical dermatology products is challenging, but Vtama is positioned to compete based on its efficacy and safety profile [100][102] Established Brands and Market Challenges - Respiratory products, particularly Singulair and Dulera, are facing significant headwinds due to price reductions and loss of contracts [122][136] - The impact of Atozet's loss of exclusivity (LOE) is expected to be less than $75 million in 2026, compared to over $200 million in 2025 [154] Growth Opportunities - Emgality is performing well, with expansion into 22 markets, showcasing Organon's capability to leverage its global infrastructure for growth [156][161] - Organon is open to acquiring additional dermatology-focused assets to capitalize on its existing sales force and capabilities [111][112] Biosimilars and Divestitures - Biosimilars are viewed as a growth driver, with successful launches of Hadlima and plans for further expansion [168][172] - Divestitures will be approached opportunistically to improve capital structure and accelerate deleveraging [180][183] Additional Insights - The company is focused on maintaining a strong balance sheet while exploring strategic partnerships and acquisitions that align with its core capabilities [111][162] - The competitive dynamics in the dermatology space and the broader healthcare market are acknowledged as critical factors influencing future performance [100][102]

Core Viewpoint - Eli Lilly and Company (NYSE: LLY) is recognized as one of the best aggressive growth stocks, with a Buy rating and a price target of $960 following a government agreement to expand access to obesity medications [1][5]. Group 1: Government Agreement and Pricing - Starting April 1, 2026, Medicare beneficiaries will pay no more than $50 per month for Zepbound (tirzepatide) and orforglipron, contingent on FDA approval [2]. - The lowest dose of Zepbound will be priced at $299, with higher doses reaching up to $449, which is $50 lower than current prices [3]. - Orforglipron will start at $149 for the lowest dose, with additional doses priced up to $399 [3]. Group 2: Additional Products and Pricing Strategy - Eli Lilly will also offer Emgality (galcanezumab-gnlm), Trulicity (dulaglutide), and Mounjaro (tirzepatide) to self-pay patients at prices 50-60% lower than current list prices [4]. - The pricing deal is expected to accelerate price reductions for these medications, although the long-term impact may be modest due to potential increases in sales and patient adherence [5]. Group 3: Market Position and Future Outlook - Medicare coverage for Zepbound is viewed as a positive development for Eli Lilly, indicating potential growth in patient access and sales [5].

Financial Performance - Revenue for Q3 2025 was $1602 million, a 1% increase compared to Q3 2024[13] - Adjusted EBITDA for Q3 2025 was $518 million, with a 323% Adjusted EBITDA margin[13] - Adjusted diluted EPS for Q3 2025 was $101, compared to $087 in Q3 2024, a 16% increase[13] - The full-year revenue range is revised to $6200 million - $6250 million, with an Adjusted EBITDA margin guidance revised to approximately 310%[13] - Free Cash Flow before one-time costs YTD September 2025 was $813 million, compared to $693 million in 2024[32] Revenue Analysis by Segment - Total Women's Health revenue was $429 million in Q3 2025, a decrease of 3% compared to Q3 2024[17] However, year-to-date Women's Health revenue increased by 3% to $1354 million[15,17] - Nexplanon revenue was $223 million in Q3 2025, a decrease of 8% compared to Q3 2024[17] - Total Biosimilars revenue was $196 million in Q3 2025, a 19% increase compared to Q3 2024[20] Year-to-date Biosimilars revenue increased by 2% to $510 million[20] - Hadlima revenue increased by 57% to $63 million in Q3 2025[20] - Total Established Brands revenue was $956 million in Q3 2025, a 1% increase compared to Q3 2024[24] Year-to-date Established Brands revenue decreased by 5% to $2778 million[24] Geographic Performance - United States revenue increased by 2% to $406 million in Q3 2025[56] - Europe and Canada revenue decreased by 4% to $417 million in Q3 2025[56] - Latin America, Middle East, Russia and Africa revenue increased by 18% to $286 million in Q3 2025[56] Guidance - Full-year revenue guidance is revised to $6200 million - $6250 million, representing a nominal revenue growth of (32%) - (24%)[39] - Adjusted EBITDA margin guidance is revised to approximately 310%[39]

Core Insights - Trump announced agreements with pharmaceutical giants Novo Nordisk and Eli Lilly to reduce the prices of their popular weight loss drugs [3][4] - Novo Nordisk plans to set the monthly price for the lowest dose of Wegovy at $149, expanding this pricing strategy to all patient-facing products [3] - Eli Lilly's lowest dose of Zepbound will start at $299, with the highest dose at $449, approximately $50 lower than current direct-to-patient prices [3] Pricing Strategies - Novo Nordisk will lower prices for its injectable drugs, including Wegovy and Ozempic, under Medicare Part D, Medicaid, and self-pay channels [3] - Eli Lilly's new oral weight loss drug, Orforglipron, will also have a minimum dose price of $149, pending federal approval [3] Market Impact - The U.S. Department of Health and Human Services Secretary stated that this initiative will significantly impact all citizens, including those without insurance, by providing equal access to GLP-1 drugs [4] - It is projected that by next year, the cumulative weight loss among Americans could reach 125 million pounds (approximately 56 million kilograms) due to increased accessibility to weight loss medications [4]

Core Points - The U.S. government has reached a price control agreement with Eli Lilly and Novo Nordisk for obesity medications, which will be available through the TrumpRx direct drug sales channel [1][3] - Novo Nordisk's semaglutide injection price will drop from $1,350 to an average of $350 per month, while Eli Lilly's tirzepatide injection and the pending oral drug Orforglipron will decrease from $1,086 to an average of $346 per month [3] - Medicare and Medicaid will now reimburse obesity medications for patients, allowing Novo Nordisk and Eli Lilly to exchange price reductions for increased volume [4] Pricing and Investment Details - Under the agreement, all doses of GLP-1 injections from Novo Nordisk and Eli Lilly will be priced at $245, with Medicare beneficiaries only paying $50 per month after reimbursement [4] - The GLP-1 injections will also be reduced to $245 in the TrumpRx channel over the next two years [4] - Novo Nordisk has committed to invest an additional $10 billion in the U.S., including local production of oral semaglutide once approved [4] Market Reactions - Following the announcement, Novo Nordisk's stock fell by 4%, while Eli Lilly's stock rose by 1.26% [5]

Core Viewpoint - The U.S. government has reached a drug price control agreement with Eli Lilly and Novo Nordisk, allowing discounted drugs to be sold through the "TrumpRx" direct sales channel [1] Group 1: Agreement Details - Novo Nordisk's semaglutide injection price will drop from $1,350 per month to an average of $350 [7] - Eli Lilly's tirzepatide injection and the pending oral drug (Orforglipron) will decrease from $1,086 per month to an average of $346 [7] - If the FDA approves the oral version of semaglutide or other oral drugs from both companies, pricing will start at $150 per month [7] Group 2: Insurance Coverage and Financial Implications - Medicare and Medicaid will reimburse obesity medications for the first time, representing a "price for volume" trade for both companies [8] - Under U.S. insurance coverage, all doses of Novo Nordisk and Eli Lilly's GLP-1 injections will be priced at $245, with beneficiaries paying only $50 per month after reimbursement [9] - The GLP-1 injections will also be priced at $245 in the "TrumpRx" channel over the next two years [10] Group 3: Additional Commitments and Investments - Novo Nordisk has committed to invest an additional $10 billion in the U.S., including local production of the oral semaglutide once approved [11] - The agreement is expected to have a "low single-digit" negative impact on global sales growth in 2026 [11] - Both companies will receive a three-year grace period from tariffs on drug imports following the agreement with the White House [12]

Core Insights - Eli Lilly and Company (LLY) reported third-quarter 2025 adjusted earnings per share (EPS) of $7.02, exceeding the Zacks Consensus Estimate of $6.02 per share, and significantly up from $1.18 per share in the same quarter last year [1][9] - Revenues reached $17.60 billion, a 54% increase year over year, driven by strong sales of GLP-1 drugs, Mounjaro and Zepbound, surpassing the Zacks Consensus Estimate of $16.01 billion [2][9] Revenue and Sales Performance - Mounjaro sales were $6.52 billion, up 109% year over year, beating the Zacks Consensus Estimate of $5.48 billion [3] - Zepbound recorded sales of $3.59 billion, a 185% increase year over year, exceeding the Zacks Consensus Estimate of $3.45 billion [4] - Trulicity generated revenues of $1.05 billion, down 19% year over year, in line with estimates [6] - Jardiance sales rose 40% to $959 million, surpassing the Zacks Consensus Estimate of $687 million [6] - Taltz brought in sales of $901.5 million, up 2% year over year, but missed the Zacks Consensus Estimate [7] - Verzenio generated sales of $1.47 billion, up 7% year over year, but also missed estimates [7] - Emgality revenues were $175.7 million, down 13% year over year, while Olumiant sales were $268.9 million, up 7% [8] Market Dynamics and Competition - Mounjaro and Zepbound are gaining market share from Novo Nordisk's Ozempic and Wegovy, despite facing strong competition [5] - The company is investing in obesity treatments and has several new molecules in clinical development, including orforglipron and retatrutide [14] Guidance and Future Outlook - Lilly raised its 2025 revenue guidance to $63.0 billion to $63.5 billion, up from a previous range of $60.0 billion to $62.0 billion, and increased EPS guidance to $23.00 to $23.70 [11][13] - The company is expanding its portfolio beyond GLP-1 drugs into cardiovascular, oncology, and neuroscience areas, with recent acquisitions to enhance its pipeline [17][18] Stock Performance - Following the strong third-quarter results and guidance increase, Lilly's shares rose more than 5% in pre-market trading, with a year-to-date increase of 5.3% compared to the industry average of 3.3% [13]

Core Insights - Eli Lilly and Company (LLY) is set to report its Q3 2025 earnings on October 30, with sales and earnings estimates at $16.01 billion and $6.02 per share respectively [1][7] - Earnings estimates for 2025 have decreased from $23.15 per share to $22.73 per share over the past month [1] Earnings Performance - The company's performance has been mixed, exceeding earnings expectations in two of the last four quarters while missing in the other two, resulting in an average earnings surprise of negative 2.31% [3] - In the last reported quarter, LLY achieved a positive earnings surprise of 12.48% [3] Earnings Expectations - LLY has an Earnings ESP of -0.66% and holds a Zacks Rank 3 (Hold) [4] - Companies with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have a higher likelihood of beating earnings estimates [5] Key Growth Drivers - The primary drivers for LLY's top-line growth in Q3 are expected to be its GLP-1 drugs, Mounjaro and Zepbound, which have seen high demand [6][7] - Sales estimates for Mounjaro and Zepbound are $5.48 billion and $3.45 billion respectively, with LLY's own estimates at $5.33 billion and $3.46 billion [8] Competitive Landscape - CVS Caremark has excluded Zepbound from its preferred drug list, which negatively impacted prescriptions in July and is expected to affect growth in Q3 [9] - Competitive dynamics have also hurt sales of Trulicity, with patient switches to Mounjaro and lower realized prices affecting revenues [11] Product Performance - Sales estimates for other key drugs include Trulicity at $1.05 billion, Taltz at $919 million, Verzenio at $1.58 billion, Jardiance at $687 million, Olumiant at $263 million, and Emgality at $196 million [11] - Newer products like Ebglyss, Jaypirca, Kisunla, and Omvoh are anticipated to contribute to sales growth [12] Strategic Initiatives - LLY is diversifying beyond GLP-1 drugs into cardiovascular, oncology, and neuroscience areas, with several M&A deals announced in 2025 [25] - The acquisition of Adverum Biotechnologies aims to enhance LLY's pipeline with gene therapies for vision loss [26] Market Position - LLY's stock has increased by 6.9% this year, outperforming the industry average of 5.6% [14] - Despite facing pricing pressures and competition, LLY remains the largest drugmaker with strong growth prospects [30]

Core Insights - Organon reported fiscal Q2 2025 results with GAAP revenue of $1.59 billion, exceeding analyst expectations, but both revenue and earnings declined compared to the previous year [1][2] - The company is focusing on new product growth while facing challenges with its legacy product portfolio [1][4] Financial Performance - GAAP revenue for Q2 2025 was $1.59 billion, slightly down from $1.61 billion in Q2 2024, but above estimates by $42 million [2][5] - Non-GAAP adjusted EPS was $1.00, beating the consensus estimate of $0.95, but down 11% from $1.12 in Q2 2024 [2][5] - Net income (GAAP) fell to $145 million from $195 million year-over-year, a decline of 25.6% [2][10] - Adjusted EBITDA (non-GAAP) increased by 1.8% to $522 million, with a margin improvement to 32.7% [2][9] Business Segments - Women's Health segment generated $462 million in sales, up 3%, driven by a 15% increase in fertility treatments [5][6] - Biosimilars revenue rose 5% to $173 million, primarily due to Hadlima, which contributed $50 million [6][8] - Established brands revenue was $936 million, down 3% year-over-year, with notable declines in Atozet and Singulair due to competition [7][8] Strategic Focus - Organon is prioritizing growth in women's health, diversifying its biosimilars portfolio, and managing its mature product lines amid generic competition [4][12] - The company aims to launch new products and expand internationally while managing costs and reducing debt [4][11] Outlook - Full-year revenue guidance for 2025 was raised to $6.275 billion–$6.375 billion, reflecting improved expectations due to foreign exchange factors [12] - Adjusted EBITDA margin guidance remains at 31.0%–32.0%, with a focus on achieving a net leverage ratio below 4.0x by year-end 2025 [12][13]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $1.6 billion, down 1% at constant currency, primarily due to the loss of exclusivity of Adazet in the EU [5][20] - Adjusted EBITDA for the quarter was $522 million, representing a 32.7% margin, with year-to-date adjusted EBITDA at $1 billion or 32.4% margin [5][6] - The company is raising its revenue guidance by $100 million at the midpoint for the full year based on year-to-date performance and foreign currency movements [5][33] Business Line Data and Key Metrics Changes - Women's health franchise grew 2% at constant currency, with the fertility business growing 15% in Q2 2025 [7][8] - Sales of Nexplanon declined 1% at constant currency in Q2, with a 5% decline in the U.S. but a 10% growth outside the U.S. [10][11] - Biosimilars, particularly HEDLEMA, performed better than expected, generating nearly $100 million, up 68% year-over-year [12][13] Market Data and Key Metrics Changes - The U.S. market for Nexplanon is facing funding constraints from federal and state programs, impacting purchasing decisions [10][11] - Pricing pressure was noted primarily from the loss of exclusivity of Adazet and certain mature products in the U.S. [21][22] - Volume increased by $90 million in Q2, representing a growth of about 5.6%, driven by fertility, HEDLEMA, Emgality, and VITAMMA [22] Company Strategy and Development Direction - The company is focused on reducing its debt burden, having repaid approximately $350 million of long-term debt in Q2 [6][31] - Aiming for a net leverage ratio below four times by year-end and further improvements to 3.5 times or below by 2026 [6][31] - The company is committed to building Nexplanon into a billion-dollar franchise and expanding its market presence [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving free cash flow of over $900 million before one-time costs in 2025 [6][41] - The company is optimistic about the growth potential of VITAMMA and expects to achieve significant access improvements by early 2026 [15][18] - Management acknowledged challenges in the U.S. market due to federal funding issues but remains confident in Nexplanon's long-term growth potential [11][53] Other Important Information - The company expects to see a modest decline in adjusted gross margin in the second half of the year but aims to land closer to the high end of the 60% to 61% range [36][39] - One-time costs related to restructuring are expected to decline, improving free cash flow conversion in the coming years [60][61] Q&A Session Summary Question: Can you talk about incremental sales and marketing investment for VITAMMA? - The company has started new telehealth and DTC campaigns and added more sales representatives, totaling over 125 in the field [44][45] Question: Can you elaborate on the federal funding headwinds for Nexplanon? - The decline in U.S. Nexplanon sales is attributed to both purchase timing and underlying pressures, with confidence in growth despite market confusion [48][52] Question: What is the expected impact of tariffs on margins in 2026? - It is too early to speculate on tariff impacts for 2026, but the EU is the largest import exposure for the company [56][57] Question: How should we think about free cash flow conversion and one-time items? - Free cash flow should grow in line with the business, with a continued reduction in one-time costs expected [60][61] Question: What is the status of the 6219 endometriosis program? - The company has decided to discontinue the program due to lack of efficacy signals [80][82] Question: Will the FDA update the guidance for generics regarding Nexplanon? - The company is working closely with the FDA for the new labeling for the five-year indication, but the FDA will make its own assessment [82][86]