Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was approximately $383 million, reflecting a reported growth of 3.7% and an organic decline of 3.5% compared to the previous year [7][23] - Adjusted EPS for the quarter was $0.41, down 25% compared to 2024 [23] - Gross margins were 52.2%, down 220 basis points from 2024, impacted by manufacturing variances and increased network optimization spending [24] - Adjusted EBITDA margins were 16.6%, down 290 basis points compared to 2024 [24] - Operating cash flow for Q1 was negative $11.3 million [24] Business Line Data and Key Metrics Changes - Codman Specialty Surgical (CSS) segment reported revenues of $281 million, with a reported growth of 9.4% and an organic decline of 1.1% [25] - Tissue Technologies revenues were $102 million, down approximately 9% on both a reported and organic basis [28] - The ENT business saw approximately $29 million in revenue from the Aclaren acquisition, with organic growth being flat due to supply constraints [25] Market Data and Key Metrics Changes - Global neurosurgery revenues declined 4.7% organically, primarily due to ship holds affecting several product lines [25] - International performance within CSS declined by high single digits, attributed to the timing and duration of ship holds [27] - Sales in wound reconstruction were down due to Integra Skin and ship holds on other products [28] Company Strategy and Development Direction - The company is focused on a turnaround strategy, emphasizing portfolio prioritization and disciplined program management to enhance operational execution [9][10] - A compliance master plan is in place to address quality system regulations and FDA observations, with significant progress reported in site assessments [12][14] - Investments are being made in manufacturing infrastructure to support long-term sustainable growth [8][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the specialized product portfolio despite current challenges [8] - The anticipated revenue headwinds from ship holds are within the assumptions made when setting guidance [20] - The company expects a revenue range of $390 million to $400 million for Q2 2025, reflecting a decline due to ship holds [19][35] Other Important Information - The company identified additional ship holds for certain products, now expecting total ship holds for the year to be between $55 million and $70 million [13][36] - The impact of recently announced global tariffs has been incorporated into the updated 2025 guidance, estimated at approximately $22 million [20][33] Q&A Session Summary Question: Guidance for Q2 and confidence in the second half of the year - Management acknowledged the impact of newly identified ship holds on Q2 guidance but noted that the guidance reflects improved production and normal seasonality [44][45] Question: Tariff impact and mitigation efforts - Management confirmed that several mitigation strategies are being pursued, including tariff exemptions and sourcing optimization, but did not include their impacts in the current guidance [47][49] Question: Demand for private label products - Management anticipates a step-up in private label demand in the second half of the year, although the forecast has been adjusted to reflect a low single-digit decline for the full year [53] Question: Remediation efforts and FDA compliance - Management is on track to complete assessments and remediation plans by year-end, with ongoing dialogue with the FDA regarding compliance [78][80] Question: Impact of ship holds on revenue guidance - Management indicated that the updated guidance allows for additional supply disruptions while still achieving the high end of the revenue range [71]

Financial Data and Key Metrics Changes - The company reported quarterly revenue of $145.5 million, with $134 million attributed to Orlodayo, marking a significant increase from the previous year [6][28] - Annual revenue guidance for Orlodayo has been raised to between $580 million and $600 million, reflecting a growth of 33% to 37% over last year [6][29] - Operating profit for Q1 2025 was $21.2 million, with net income reported as slightly positive [29] - Cash at the end of the quarter stood at $317 million, and the company reduced its outstanding debt by $75 million, bringing it down to $249 million [28][30] Business Line Data and Key Metrics Changes - The U.S. commercial team successfully transitioned patients from free drug to paid status, achieving a 10 percentage point increase in the paid patient rate, now at 84% [10][12] - The paid rate among Medicare patients improved significantly, with 89% now receiving paid therapy [93] - The gross to net ratio improved, with expectations to maintain it around 15% for the full year [14][51] Market Data and Key Metrics Changes - The company noted a strong demand for Orlodayo, with new prescriptions slightly exceeding the best quarter from the previous year [8][10] - The percentage of U.S. patients who strongly prefer oral prophylaxis increased to 70%, up from 51% in 2023 [10] - The company anticipates reaching $1 billion in global revenue by 2029, with a more profitable path than previously expected [13][64] Company Strategy and Development Direction - The company is focusing on expanding its pipeline, with significant milestones achieved, including the submission of a pediatric NDA for Orlodayo [16] - The company aims to capture more revenue from Orlodayo as the patient base continues to grow, with a long-term goal of 85% paid therapy [12][13] - The company is committed to disciplined capital allocation to create sustainable long-term revenue growth while reducing debt [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of the paid rate improvement, viewing 84% as a new floor for future performance [118] - The company is optimistic about the impact of the Inflation Reduction Act on patient affordability and access to Orlodayo [11][57] - Management highlighted the importance of real-world evidence in convincing payers of the drug's efficacy, which has improved payer conversations [94] Other Important Information - The company is preparing for the launch of a pediatric formulation of Orlodayo, with expectations for rapid deployment following approval [106] - The company is also advancing its clinical pipeline, with a focus on rare diseases and the potential for transformative treatments [16][18] Q&A Session Summary Question: What is the potential impact of the pediatric launch on Orlodayo? - Management expects the pediatric launch to be a significant tailwind, with around 500 pediatric patients in the U.S. potentially appropriate for prophylactic therapy [35][36] Question: Can you elaborate on the improvements in getting patients onto paid drug? - The team made investments in the reauthorization process and improved their execution, leading to a higher paid rate [46][47] Question: What benchmarks are being set for the DME program? - The company is looking for a clear reduction in retinal edema as a benchmark for moving forward with the DME program [41][97] Question: How sustainable is the paid rate improvement? - Management believes the paid rate improvement is sustainable, with 84% being a new baseline for future performance [118] Question: What is the expected timeline for the pediatric formulation launch? - The company aims to minimize the lag time between approval and market availability, similar to previous launches [106][107]

Exagen (XGN) Q1 2025 Earnings Call May 05, 2025 08:30 AM ET Speaker0 Greetings, and welcome to the Exagen Inc. First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Ryan Douglas, Investor Relations for Exagen Inc. Thank you. You may begin. Speaker1 Good morning, and th ...

Financial Data and Key Metrics Changes - In 2024, the company's full year revenue increased by 32%, reaching $45 billion, with fourth quarter revenue growing by 45% [19] - The company invested nearly $11 billion in R&D, representing about 24% of its revenue, with an 18% year-over-year increase [19] - A new $15 billion share repurchase program was announced, marking the seventh consecutive year of a 15% increase in quarterly dividends [19] Business Line Data and Key Metrics Changes - The performance of Monjaro, Zepbound, and Verzenio significantly contributed to revenue growth [16] - The company launched five new medicines since 2022, including Evolus, Jaypirca, Kisunla, Monjaro, Zepbound, and Omvoh, enhancing patient reach [18] Market Data and Key Metrics Changes - The company expanded its manufacturing capacity to meet increasing demand and opened new facilities, including the Lilly Seaport Innovation Center in Boston and a Lilly Gateway Lab in the UK [20][21] - A major investment in the United States was announced, bringing total manufacturing commitments since 2020 to over $50 billion [21] Company Strategy and Development Direction - The company remains focused on solving serious healthcare problems and aims to deliver life-changing medicines to millions [16] - The long-term balanced growth strategy includes advancements in obesity, diabetes, oncology, neuroscience, and immunology [16] - The company is complementing its pipeline through acquisitions and collaborations, such as acquiring Morphic Therapeutics and partnering with OpenAI [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for significant growth from late-stage readouts in 2025 [17] - The company is committed to enhancing supply chain resilience and creating high-paying jobs through its investments [21] - Management emphasized the importance of their workforce and collaborations in achieving their goals [22] Other Important Information - The proposals to amend the articles of incorporation regarding the board structure and voting provisions did not receive the required votes [15] Q&A Session Summary Question: Does the compensation committee use the compensation actually paid total in setting the CEO target total compensation award for the coming year? - Management clarified that the compensation actually paid is not used to set the target compensation, as it reflects a mark-to-market value rather than actual compensation [26][28] Question: How much training is provided to employees to prevent clicking on links resulting in malware or breaks in cybersecurity? - Management confirmed that a comprehensive cybersecurity program is in place, including training to prevent incidents related to malware [29]

Twist Bioscience (TWST) Q2 2025 Earnings Call May 05, 2025 08:00 AM ET Company Participants Angela Bitting - SVP - Corporate Affairs & Chief Corporate Responsibility OfficerEmily Leproust - CEO and Co-FounderPatrick Finn - President & COOAdam Laponis - Chief Financial OfficerSubbu Nambi - Managing DirectorDoug Schenkel - Managing DirectorPuneet Souda - Senior MDTom Peterson - Senior Research Associate Conference Call Participants Luke Sergott - AnalystMatthew Sykes - AnalystVijay Kumar - AnalystMatt Larew - ...

BioNTech (BNTX) Q1 2025 Earnings Call May 05, 2025 08:00 AM ET Company Participants Michael Horowicz - Director - IRUgur Sahin - Co-Founder, CEO & Chair of the Management BoardÖzlem Türeci - Co-Founder, Chief Medical Officer & Member of Management BoardJens Holstein - CFORyan Richardson - Chief Strategy OfficerAkash Tewari - Managing DirectorCory Kasimov - Senior Managing DirectorMohit Bansal - Managing DirectorKarina Rabayeva - VP - Biotech Equity ResearchHarry Gillis - Vice President - Pharmaceuticals Equ ...

Freshpet (FRPT) Q1 2025 Earnings Call May 05, 2025 08:00 AM ET Speaker0 Greetings and welcome to Freshpet's First Quarter twenty twenty five Earnings Call. At this time, participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Rachel Ulsh, Vice President, Investor Relations. Thank you. You may begin. Speaker1 Good morning, and welcome to Freshpet's First Quarter twenty twent ...

Henry Schein (HSIC) Q1 2025 Earnings Call May 05, 2025 08:00 AM ET Speaker0 Good morning, ladies and gentlemen. Welcome to Henry Schein's First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in listen only mode. Later, we'll conduct a question and answer session. Please press the star key followed by one on your touch tone phone if you'd like to ask a question at the end of the call. If anyone should require operator assistance during the call, please press the star ...

Recursion Pharmaceuticals (RXRX) Q1 2025 Earnings Call May 05, 2025 08:00 AM ET Speaker0 Hi, everybody. My name is Chris Gibson, cofounder and CEO of Recursion, and I'm delighted to welcome you to our learnings call this morning. We're gonna go ahead and get started. Perfect. So, of course, important to note that we're gonna be providing forward looking information today, so please understand all of these important caveats. So I wanna begin by just talking a little bit about Recursion's mission, which is to ...

Financial Data and Key Metrics Changes - Total product revenues for Q1 2025 were $121.5 million, representing a year-over-year growth of 62% compared to $75 million in Q1 2024 [16][17] - Net loss for Q1 2025 was $59.4 million or $1.22 per share, an improvement from a net loss of $68.4 million or $1.44 per share in Q1 2024 [20] - Cash and cash equivalents at the end of Q1 2025 were $300.9 million, down from $315.4 million at year-end [20] Business Line Data and Key Metrics Changes - Avelity net product sales were $96.2 million for Q1 2025, representing 80% year-over-year growth from $53.4 million in Q1 2024 [17] - Sunosi net product revenues were $25.2 million for Q1 2025, a 17% year-over-year increase from $21.6 million in Q1 2024 [17][18] - Avelity led the market in TRx growth in Q1 with approximately 167,000 prescriptions, reflecting 76% year-over-year growth [21] Market Data and Key Metrics Changes - Avelity coverage remained stable in Q1 with 78% of all lives covered across channels and 63% in the commercial segment [22] - Sunosi total prescriptions were over 46,000, representing a 12% growth versus Q1 2024 [23] - Payer coverage for Sunosi was stable with 83% of lives covered across channels [25] Company Strategy and Development Direction - The company aims to advance three novel NDA stage product candidates: AXS-fourteen for fibromyalgia, AXS-five for Alzheimer's disease agitation, and AXS-twelve for narcolepsy [6][10] - The company is focused on executing multiple Phase III clinical programs to broaden the potential of current products and candidates [6] - The company anticipates a strong launch for Cymbravo, with positive feedback from healthcare providers regarding its clinical profile [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate trade policy developments, stating that any potential impact would be immaterial [13] - The company expects 2025 to be a catalyst-rich year with potentially five marketed products across six indications by 2026 [15] - Management remains optimistic about achieving cash flow positivity based on the current operating plan [20][96] Other Important Information - The company has submitted an NDA for AXS-fourteen and anticipates a decision in Q2 2025 [7] - AXS-five has been granted breakthrough therapy designation by the FDA, with an sNDA submission planned for Q3 2025 [9] - The company is closely monitoring the competitive landscape, particularly regarding new entrants in the narcolepsy treatment space [35] Q&A Session Summary Question: Recent interactions with the FDA regarding developmental agents - Management indicated that dialogue with the FDA remains status quo and no changes have been noted regarding review teams or agency responsiveness [30] Question: DTC advertising plans for Avelity - A national campaign is expected to launch later this year, with a focus on engaging patients [34] Question: Coverage expectations for Avelity - Management aims to increase the number of covered lives and reduce utilization management barriers [68] Question: Expected cadence of coverage for Cymbravo - Management is focused on securing access quickly, acknowledging the competitive market [48] Question: Sales potential for AXS-fourteen in fibromyalgia - Management is enthusiastic about the market opportunity, with approximately 17 million people diagnosed in the U.S. [63] Question: Profitability outlook for 2025 - Management remains confident in achieving cash flow positivity but has not provided specific guidance on timing for profitability [96]