QuidelOrtho (NasdaqGS:QDEL) Q4 2025 Earnings call February 11, 2026 05:00 PM ET Speaker10Good morning or good afternoon. Welcome to the QuidelOrtho fourth quarter and full year 2025 financial results conference call and webcast. At this time, all participants are in a listen-only mode. For those of you participating in the conference call, there will be an opportunity for your questions at the end of today's prepared remarks. Please note this conference call is being recorded. An audio replay of the confere ...

Core Insights - Lexicon Pharmaceuticals (NASDAQ:LXRX) is recognized as a rapidly growing penny stock, with significant advancements in its product pipeline highlighted at the Jefferies London Healthcare Conference 2025 [1][2]. Pipeline Development - The company is preparing for an end-of-phase two meeting with the US FDA regarding pilavapadin, a drug aimed at treating neuropathic pain [2]. - Lexicon is accelerating patient enrollment in the SONATA trial, which focuses on hypertrophic cardiomyopathy (HCM) [2]. - The company plans to resubmit Zynquista for type 1 diabetes to the FDA in early 2026 [2]. Clinical Results - At the American Heart Association Annual Scientific Sessions 2025, Lexicon presented topline results for sotagliflozin, indicating significant improvements in heart failure patients with preserved ejection fraction [3]. - The study on sotagliflozin is noted as the first to demonstrate clinical benefits for heart failure patients without diabetes [4]. Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical firm that specializes in discovering, developing, and commercializing treatments for serious and chronic diseases, focusing on cardiometabolic and neuroscience conditions [5].

Financial Data and Key Metrics Changes - The company has a strong financial profile with significant cash flow and a growing balance sheet, indicating a robust near to medium-term outlook [5] Business Line Data and Key Metrics Changes - The company is focusing on the development of targeted therapies in the oncology and immunology sectors, particularly in myeloproliferative neoplasms (MPNs) and immune-mediated skin conditions [5][12] - The company plans to launch Jakafi XR in 2026, which is expected to preserve some revenue from Jakafi during the transition period [10][11] Market Data and Key Metrics Changes - The estimated market for essential thrombocythemia (ET) is approximately $5 billion, with a significant portion of that market being relevant for targeted therapies like 989 [21] - The total addressable market (TAM) for therapies targeting MPNs is projected to be around $7.5 billion, with potential penetration rates varying between 2% and 5.5% [45] Company Strategy and Development Direction - The company aims to establish a new standard of care for MPNs through the development of targeted therapies, with a focus on five different therapies currently under development [12][13] - The company is also exploring expansion opportunities in the immunology sector, particularly with Opsilura and Povo, which are expected to grow significantly in the coming years [52][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for product flow and the ability to build the company over the next decade, emphasizing the depth of scientific expertise within the organization [5][6] - The management team is optimistic about the upcoming data releases and the potential for pivotal trials in ET and myelofibrosis [16][20] Other Important Information - The company is actively engaging with regulatory bodies like the FDA to discuss pivotal trial designs and endpoints for their therapies [26][28] - The company has a backup plan for its 617F program, ensuring that it remains committed to addressing the needs of patients with MPNs [51] Q&A Session Summary Question: What is the opportunity in essential thrombocythemia (ET)? - Management highlighted that while ET is considered indolent, it is not benign, and there is a significant market opportunity for targeted therapies, particularly for high-risk patients [21][23] Question: What are the plans for pivotal trial design in ET? - The company is considering a straightforward design for pivotal trials in ET, focusing on complete hematologic response and potentially incorporating novel endpoints [25][26] Question: How does the company view the safety of combination therapies? - Management expressed confidence that the combination of their therapies with Jakafi would not present significant safety liabilities, based on preclinical data [42][43] Question: What is the growth potential for Opsilura and Povo? - The company anticipates double-digit growth for Opsilura and sees significant potential for Povo in the HS market, with plans for NDA submission in early 2026 [52][54] Question: What is the strategy for business development? - The company is focused on hematology, oncology, and immunology, with a clear strategy to build a portfolio rather than pursuing isolated assets [61][64]

Financial Data and Key Metrics Changes - The company experienced a 50% increase in revenues from selling goods compared to the same period last year [3] - Revenues from selling goods were $15.4 million for Q2 2025, an increase of $2.1 million or 16% compared to $13.3 million for Q2 2024 [12] - Net income for Q2 2025 was approximately $164,000 or $0 per share, compared to a net loss of approximately $2.2 million or $0.03 per share for the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by sales of Elfabrio to Chiesi, with an increase of $8 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Brazil and $1.2 million in sales to Pfizer [12] - Research and development expenses increased by $3 million or 100% to approximately $6 million in Q2 2025, primarily due to preparations for the planned Phase II clinical trial of PRX-115 [14] Market Data and Key Metrics Changes - The global market for Fabry disease is approximately $2.3 billion in 2025 and is forecasted to reach approximately $3.2 billion by 2030 [4] - The company anticipates El Fabryo royalties exceeding $100 million by 2030 based on a projected 15% to 20% market share of the estimated $3.2 billion Fabry total market [6] Company Strategy and Development Direction - The company is focused on building its product development pipeline, particularly in early-stage development assets and therapeutic areas related to renal rare diseases [8] - The company plans to initiate a Phase II study for PRX-115 in 2025 and enroll the first patient in Q4 2025 [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic plan and the foundation being built for future growth, emphasizing the excitement around the Phase II program for PRX-115 [18] - The management noted that Chiesi has been performing better than expected in the marketplace, with significant growth in patient acquisition [28] Other Important Information - The company had $33.4 million in cash and cash equivalents and short-term bank deposits as of June 30, 2025 [16] - Eyal Rubens, the Chief Financial Officer, is stepping down after six years, and Gilad Mambloc will succeed him [9][10] Q&A Session Summary Question: Comments on Chiesi's planned study called Pagasso - Management confirmed it is part of Chiesi's phase four program to enhance the merits and strengths of the program [22][23] Question: Details on the Phase II trial for PRX-115 - The company plans to operate between 20 to 30 sites for the trial, primarily in the U.S. [24][25] Question: Market share held by Chiesi in Fabry disease - Management stated they do not disclose specific market share numbers but assured that Chiesi is performing well and growing its market share [27][28] Question: Utilization of Gilad's experience in business development - Management clarified that while Gilad has significant experience, the company is currently not planning any mergers or acquisitions and is focusing on growing its pipeline [30][32]

Financial Data and Key Metrics Changes - Total product revenues for Q2 reached $1,060 million, a 17% increase year over year, driven by strong demand for Jakafi and Opsilura, as well as contributions from Nictimvo's launch [20][21] - Total revenues were $1,220 million, up 16% compared to the same period last year [20] - Jakafi net product revenue was $764 million for Q2, representing an 8% growth year over year [20] - Opsilura's net product revenue for Q2 was $164 million, a 35% increase year over year [21] - The company raised its full-year revenue guidance for Jakafi to a range of $3,000 million to $3,050 million [21] Business Line Data and Key Metrics Changes - Opsilura showed strong growth across atopic dermatitis and vitiligo, with nearly 20,000 prescribers and potential for new indications [7][21] - Nictimvo generated $36 million in net product revenues in Q2, with rapid adoption among BMT centers [23] - Other hematology-oncology products saw net revenues of $131 million, a 66% year over year increase, driven by the Nectinvo launch and higher demand for ZYNES [25] Market Data and Key Metrics Changes - U.S. net product revenue for Opsilura was $132 million, up 19% year over year, while ex-U.S. revenues were $32 million, driven by uptake in France, Germany, and recent launches in Italy, Spain, and Canada [22] - Nictimvo achieved approximately 82% account penetration in BMT centers across the U.S. [23] Company Strategy and Development Direction - The company aims to build a comprehensive plan for acceleration, focusing on R&D productivity, operating expenses, and capital allocation [9][17] - Strategic priorities include taking care of core products, accelerating product development, and careful capital allocation [9][14] - The company recognizes the importance of converting scientific advancements into regulatory approvals and business results [9][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for new product flow and emphasized the importance of execution in driving growth [5][18] - The company expects FDA approval for Opsilura in pediatric patients by September and is on track with pivotal trials for povastatinib [18] - Management highlighted the need to manage expenses in a disciplined manner while focusing on growth [17][28] Other Important Information - The company recorded a benefit of $242 million from a contract dispute settlement with Novartis, leading to a reduction in COGS [25] - R&D expenses for Q2 were $495 million, with an increase of 8% year over year, driven by investments in late-stage development assets [26] Q&A Session Summary Question: Importance of therapeutic areas at Incyte - Management indicated that MPNs are the most important therapeutic area, with a significant opportunity to transform treatment in this space [43][44] Question: Read-through from Kallar data for ET and expectations for MF - Management noted that the mechanism of action for the mutant CalR antibody suggests a high probability of success in MF based on ET data [52][53] Question: Initial data for six seventeen F and its delay - The delay was attributed to the need for higher doses and longer follow-up to obtain sufficient data [56][59] Question: Dynamics of Nictimvo's launch and inventory impact - Management reported a 10% penetration in the third-line market and noted that inventory accounted for less than 5% of Q2 sales [70][75] Question: Balancing investment in pipeline advancement and external opportunities - Management emphasized the importance of capital allocation and the need to make informed decisions based on facts and analysis [96][99]