Vaxart (NasdaqCM:VXRT) FY Conference February 25, 2026 04:00 PM ET Company ParticipantsCheng Li - Director of Biotech Equity ResearchJames F. Cummings - Chief Medical OfficerSteven Lo - President and CEOCheng LiHello, welcome to Oppenheimer's 36th Annual Healthcare Conference. I am Cheng Li, one of the biotech analysts here at Oppenheimer, and it's a pleasure to welcome you to our next company, Vaxart. It's my honor to introduce Steven Lo, CEO, and James Cummings, CMO at Vaxart. We want to leave probably a ...

Moderna (NASDAQ: MRNA) became a household name during the coronavirus pandemic. There's a good reason for that: Its mRNA technology enabled the rapid development of a vaccine. The financial benefit of that success for Moderna was huge, but what comes next? Moderna hits a home run The onset of the COVID-19 pandemic was a global event and a material shock to the world's healthcare system. Moderna used its mRNA technology to help develop a vaccine in record time. The company's reward was a massive revenue sp ...

Core Insights - Moderna reported fourth-quarter results that exceeded expectations, with shares rising more than 8% intra-day on Friday [1] - The company posted a quarterly loss of $2.11 per share, narrower than analyst estimates of a $2.62 loss, and revenue reached $678 million, down 30% year over year [1] - For full-year 2025, Moderna generated revenue of $1.9 billion, representing a 40% decline from 2024, with a net loss of $2.8 billion or $7.26 per share [2] Financial Performance - Fourth-quarter revenue was $678 million, modestly above the consensus forecast of $662.84 million [1] - Full-year 2025 revenue was $1.9 billion, a 40% decline from 2024 [2] - Cash and investments totaled $8.1 billion at year-end 2025, down from $9.5 billion at the end of 2024 [2] Future Outlook - Moderna reaffirmed its goal of achieving up to 10% revenue growth in 2026, with approximately half expected from U.S. markets and half from international markets [3] - The company expects research and development expenses of approximately $3.0 billion and selling, general, and administrative expenses of about $1.0 billion for 2026 [4] - Year-end cash and investments for 2026 are projected to range between $5.5 billion and $6.0 billion [4] Pipeline Developments - Moderna reported full enrollment in its Phase 3 Norovirus trial, with data anticipated in 2026 [4] - The company also achieved full enrollment in its Phase 2 intismeran autogene study for muscle invasive bladder cancer [4] - The influenza vaccine filing has been accepted for regulatory review in the European Union, Canada, and Australia, but received a Refusal-to-File letter from the U.S. FDA [3]

Core Insights - The company reported fourth quarter revenue of $0.7 billion, with a GAAP net loss of $(0.8) billion and a GAAP EPS of $(2.11) [1] - For the full year, revenue was $1.9 billion, with a GAAP net loss of $(2.8) billion and a GAAP diluted EPS of $(7.26) [1] - The company reiterated its plan to achieve up to 10% revenue growth and reduce GAAP operating expenses by 2026 [1] Regulatory and Clinical Updates - The company announced that its influenza vaccine filing has been accepted for regulatory review in the EU, Canada, and Australia; however, it received a Refusal-to-File letter from the U.S. FDA and has requested a Type A meeting to clarify the path forward [1] - The Norovirus Phase 3 trial is fully enrolled, with data readout expected in 2026 [1] - Full enrollment of the Phase 2 intismeran autogene trial in muscle invasive bladder cancer has been achieved [1] Business Developments - In 2025, the company focused on sharpening its commercial execution, launched its third product, and brought online three international manufacturing sites while advancing its mRNA pipeline [1]

Core Viewpoint - Moderna shares experienced a 14% decline in Frankfurt following the U.S. FDA's refusal to review the company's influenza vaccine approval application [1] Company Summary - Moderna's stock opened 14% lower in Frankfurt, indicating a significant market reaction to the FDA's decision [1] - The trading volume was low, suggesting limited investor activity during this period [1] Industry Summary - The refusal by the U.S. FDA to review the influenza vaccine application may impact the broader vaccine market and investor sentiment towards vaccine developers [1]

Core Insights - The flu season in the U.S. is intensifying, with a new strain raising concerns about the effectiveness of current vaccines against it [3][4][15] - Public health experts indicate that while the flu season is in a high transmission phase, it has not yet peaked, and the increase in cases aligns with historical patterns [3][4][15] - COVID-19 cases remain low, with wastewater monitoring showing virus levels significantly below summer peak levels [3][4][18] Flu Season Dynamics - The current flu season is driven by a new strain of the H3N2 virus, which has become the dominant strain in the U.S. [9][20] - The CDC reports a significant rise in flu-related hospitalizations, emergency visits, and deaths, with projections indicating the peak may occur in February [4][20] - As of now, there are at least 4.6 million flu cases, over 49,000 hospitalizations, and approximately 1,900 deaths reported [20][21] Vaccine Effectiveness Concerns - Experts express concern that the new strain may reduce the effectiveness of the flu vaccine, potentially leading to increased hospitalizations [10][11][20] - Approximately 40% of U.S. adults have received the current flu vaccine, with slightly lower rates among children [21] - Despite the emergence of the new strain, vaccination remains crucial to reduce severe illness and hospitalization risks [21][22] Public Health Recommendations - Public health officials continue to urge the public to complete COVID-19 vaccinations and conduct testing as winter approaches [18] - The flu season is expected to last until March or April, with the potential for severe impacts if vaccination rates do not improve [20][22] - There is a noted increase in flu symptoms among children, highlighting the importance of timely diagnosis and treatment [21][22]

Group 1 - The National Health Commission emphasizes the importance of flu vaccination as an effective preventive measure against influenza, particularly for vulnerable groups such as the elderly, children, and those with chronic illnesses [1] - Flu vaccination services are becoming more accessible, with many community health service centers offering convenient appointment options, encouraging higher vaccination rates for better community protection [1] - Common mild side effects of flu vaccination should not deter individuals from getting vaccinated, as the benefits outweigh the risks [1] Group 2 - Good hygiene practices are essential, including using tissues or elbows to cover coughs and sneezes, maintaining hand hygiene, and avoiding touching the face with unclean hands [2] - It is recommended to wash hands and change clothes upon returning home, especially after being in public, to minimize the risk of spreading infections [2] - Creating a fresh indoor environment through regular ventilation and cleaning, as well as disinfecting frequently touched surfaces, is crucial for health [2] Group 3 - Special precautions are advised for elderly individuals during rainy or snowy weather to prevent falls, including wearing non-slip shoes and walking slowly [3] - Outdoor workers, such as sanitation workers and delivery personnel, should take extra care to stay warm and protected from the cold, and are encouraged to get vaccinated against the flu [3] - Staying informed about weather forecasts and warnings is important for maintaining health and safety during winter [3]

Summary of the Conference Call on China's Plasma Industry Industry Overview - The conference call focused on the plasma product industry in China, specifically the performance of seven A-share listed plasma product companies in Q3 2025 [1][2]. Key Points Revenue Growth - The combined revenue growth of the seven listed plasma product companies turned positive, attributed to three M&A transactions since Q4 2024 [1]. - However, on a comparable basis, revenue growth remains negative for these companies [1]. Albumin Market Dynamics - Lot release volumes of albumin increased by 6% in the first nine months of 2025 [9]. - Despite the increase in volume, terminal prices of albumin have continued to decline, indicating an oversupply situation [1][19]. Policy Impact - Demand for plasma products is negatively affected by policy factors such as DRG/DIP reform, tighter medical insurance cost control, and enhanced monitoring of off-label use [1]. Company-Specific Performance - Hualan's Q3 2025 revenue was Rmb1,581 million, down 14% year-over-year, and net profit was Rmb269 million, down 44% year-over-year, missing Goldman Sachs estimates [25]. - The decline in Hualan's performance was attributed to seasonal fluctuations in influenza vaccine sales and lower-than-expected plasma product sales [25]. New Product Launch - Oryzogen's rice-derived recombinant albumin was approved for market launch, with production costs expected to decrease as capacity expands [19][20]. - The seven listed companies noted differences between plasma-derived and recombinant albumin, particularly in immunogenicity and production costs, with plasma-derived products holding advantages [20]. Industry Consolidation - The trend of mergers and acquisitions in the plasma industry is increasing, with no new plasma product companies approved since 2001, leading to higher industry concentration [23]. - Notable M&A transactions include Boya Biopharm selling shares to China Resource and Hualan's acquisition of a subsidiary from CSL [24]. Financial Estimates and Risks - Hualan's target price was revised to Rmb18 from Rmb19, reflecting earnings revisions and industry trends [25]. - Key risks include stricter controls on albumin prescriptions, rising accounts receivable days, and intensified competition in the influenza vaccine market [30]. Additional Insights - Inventory turnover days for most listed companies declined, indicating that inventories are not currently a burden [15]. - However, accounts receivable days peaked in Q3 2025, suggesting that distributors may be taking on more inventory due to sales pressure [16]. This summary encapsulates the critical insights from the conference call regarding the plasma product industry in China, highlighting both opportunities and challenges faced by the companies involved.

Core Viewpoint - Australian biotech CSL has announced that it will not complete the spin-off of its vaccine division in fiscal 2026 due to increased volatility in the U.S. influenza vaccine market [1] Company Summary - CSL's decision to delay the spin-off reflects concerns over market conditions, particularly in the U.S. influenza vaccine sector [1]

Core Insights - Moderna, Inc. is recognized as one of the top AI-powered biotech stocks to consider for investment [1] - The company specializes in mRNA therapeutics and vaccines, with a focus on expanding its pipeline beyond COVID-19 [2] Company Overview - Moderna, Inc. is based in Cambridge and is a leader in mRNA technology, particularly known for its COVID-19 vaccine [2] - The company is diversifying its vaccine offerings to include influenza, RSV, CMV, Zika, and combination vaccines, as well as mRNA therapeutics for oncology, rare diseases, and cardiovascular conditions [2] - Moderna operates globally, with manufacturing facilities in the U.S. and Europe, and utilizes strategic alliances and technology transfers to enhance its operations [2] Market Challenges - In September 2025, Moderna's stock experienced a nearly 7% decline due to reports linking COVID-19 vaccines to approximately 25 child deaths, which raised investor concerns despite the lack of scientific consensus [3] - Policy changes, such as Florida's removal of vaccine mandates, have further complicated near-term demand forecasts for the company [3] Commitment to Safety - The company emphasizes transparency and scientific rigor, citing that over a billion doses of its vaccines have been administered globally, which supports public trust and regulatory engagement [4] Innovation and Technology - Moderna is advancing its mRNA applications beyond COVID-19, integrating AI and machine learning into its R&D pipeline to enhance mRNA design, optimize vaccine formulations, and predict immune responses [5] - This combination of scientific rigor and technological innovation positions Moderna favorably among biotech stocks that are adapting to future healthcare needs [5]