Key Takeaways Moderna is expected to beat Q4 estimates, with sales projected at $661.4M and a loss of $2.60 per share.COVID-19 vaccines are expected to drive most sales, while the RSV vaccine mResvia faces tough competition.Investors await updates on intismeran studies and FDA resubmission plans for the COVID-flu combo vaccine.We expect Moderna (MRNA) to surpass expectations when it reports fourth-quarter and full-year 2025 results on Feb. 13, before the opening bell. The company’s earnings beat estimates b ...

Core Viewpoint - Recordati has entered into a collaboration and license agreement with Moderna to develop and commercialize mRNA-3927, an investigational product for treating propionic acidemia, leveraging Moderna's mRNA technology and Recordati's commercial infrastructure [1][6]. Group 1: Collaboration Details - The agreement allows Moderna to lead the development of mRNA-3927, while Recordati will handle global commercialization if the product is approved [1]. - Recordati will pay Moderna an upfront payment of USD 50 million, with potential additional payments of up to USD 110 million based on development and regulatory milestones [4]. - The transaction is subject to customary closing conditions, including U.S. antitrust clearance expected within 30 days [5]. Group 2: Product Information - mRNA-3927 aims to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia, a rare inherited metabolic disorder characterized by toxic metabolite buildup [2][7]. - Interim clinical data published in Nature indicates early signs of clinical improvement, with a potential data readout expected by the end of 2026 [3][10]. - mRNA-3927 is designed as a targeted disease-modifying therapy and is currently in a registrational clinical study to reduce metabolic decompensation events [3][10]. Group 3: Market Context - Propionic acidemia affects approximately 1 in 100,000-150,000 individuals globally and currently lacks effective therapies targeting the disease's root cause [7]. - The collaboration aims to address the significant unmet medical need for disease-modifying treatment options in this patient population [6].

Core Viewpoint - Moderna's stock has experienced a significant decline of 91% since its peak during the pandemic, but recent positive developments in cancer vaccine trials may signal a potential recovery for the company [2][10]. Group 1: Stock Performance and Market Sentiment - Shares of Moderna rose by 16% on January 21 following encouraging results from a skin cancer vaccine developed in partnership with Merck [3]. - The stock is currently trading 40% above Wall Street's average price target of approximately $30, indicating skepticism about further price increases [6]. - 18.8% of Moderna's shares are sold short, suggesting that if the company can diversify its offerings beyond its declining Covid franchise, there may be upward pressure on the stock price [6]. Group 2: Clinical Trials and Product Pipeline - Moderna and Merck are conducting multiple clinical trials to explore the potential of their mRNA technology in treating various cancers, including lung, kidney, and bladder cancers [4]. - The Phase 3 trial results for a personalized skin cancer vaccine showed a 49% reduction in recurrence or death after five years among high-risk melanoma patients [8]. - The market potential for the skin cancer vaccine is substantial, with peak sales projected to reach billions, particularly as the American Cancer Society estimates that around 112,000 people in the U.S. will be diagnosed with melanoma in 2026 [9]. Group 3: Future Scenarios and Analyst Perspectives - Analysts present three potential scenarios for Moderna's stock: a status quo scenario with stock prices stabilizing between $30 and $50, a pessimistic scenario with prices dropping to $15 to $20 if the cancer vaccine fails, and an optimistic scenario where prices could rise to between $100 and $190 if the cancer vaccine is successful [12][13]. - The average price target among analysts is $29, reflecting mixed views on the company's future performance [14]. - An optimistic outlook hinges on the effectiveness of the cancer vaccine, with potential implications for commercialization in other cancer types [15]. However, some analysts remain cautious, citing challenges in similar treatments and logistical hurdles [16].

Core Insights - BioNTech is shifting its focus back to oncology, leveraging its mRNA technology for cancer treatment [2][5] - Goldman Sachs upgraded BioNTech from Neutral to Buy, citing the company's potential in cancer treatment [2][5] - BioNTech has a substantial cash reserve of $17 billion to support late-stage development [2][5] Company Performance - BioNTech has delivered five billion doses of its COVID-19 vaccine globally, reaching over 180 countries [3][5] - The company is conducting 25 clinical trials with 16 clinical programs currently in progress [3][5] - Despite a recent stock price decrease of 2.80%, the current price is $106.07, with a market capitalization of approximately $25.51 billion [4]

Summary of Moderna's Presentation at the JPMorgan Healthcare Conference Company Overview - **Company**: Moderna - **Event**: 44th Annual JPMorgan Healthcare Conference - **CEO**: Stéphane Bancel Key Points Industry and Company Strategy - Moderna aims to build a respiratory vaccine franchise to generate cash for investments in oncology and rare disease assets [2][3] - The company has three FDA-approved products and two products submitted for regulatory approval (flu and flu plus COVID) [2][3] - A focus on diversifying away from COVID-19 vaccines to ensure future growth [3] Financial Performance - Sales guidance for 2025 was initially $1.62 billion, but the company expects to achieve around $1.9 billion, exceeding the midpoint of the range by $100 million [3] - Cash costs have been significantly reduced from $6.3 billion in 2024 to an expected $4.3-$4.5 billion by the end of 2025, a reduction of nearly $2 billion [5][6] - The company ended 2025 with a cash balance of $8.1 billion, including a credit facility providing liquidity of $9 billion [7] Growth Drivers - **Geographic Diversification**: Partnerships in the U.K., Canada, and Australia to build dedicated factories, ensuring long-term volume commitments [8] - **New Product Launches**: Introduction of mRESVIA, a higher efficacy COVID vaccine, which has achieved a 24% market share in retail and 32% in the elderly segment [9] - Anticipation of re-entering the European market for COVID vaccines post-2026 due to the expiration of Pfizer's partnership with the EU [10][11] Pipeline and R&D - A robust oncology pipeline with 10 clinical studies ongoing for mRNA-4157 combined with Keytruda, including three phase three studies [14][15] - Potential for significant breakthroughs in oncology with mRNA-4359 and mRNA-2808, targeting metastatic settings and multiple myeloma, respectively [15][37] - Upcoming readouts expected in 2026 for various oncology products, including phase three data for mRNA-4157 [18][23] Market Dynamics - The company anticipates a potential sales growth of up to 10% in 2026, driven by both U.S. and international markets [38] - The U.S. market is experiencing a decrease in COVID vaccine volume, but the introduction of new products and partnerships is expected to stabilize sales [39][40] - The flu vaccine (mRNA-1010) is expected to launch in 2027, with minimal sales anticipated in 2026 due to regulatory timelines [44][45] Cost Management and Profitability - Continued focus on cost discipline to achieve cash break-even by 2028, with a reduction in R&D costs as existing phase three commitments sunset [21][22] - Gross margin improvements expected through increased volume, productivity enhancements, and internal manufacturing capabilities [50][51] Conclusion - Moderna is positioned for growth through strategic diversification, innovative product launches, and effective cost management, with a strong focus on oncology and respiratory vaccines as key areas for future development [22][25]

Core Viewpoint - Arcturus Therapeutics is positioned as a high-potential biotech stock under $10, with expectations of a 404% increase by 2026 due to promising clinical data and a clear development pipeline [1]. Company Overview - Arcturus Therapeutics (ARCT) focuses on developing mRNA-based medicines and vaccines, aiming to address root causes of diseases rather than just symptoms [2]. - The company is currently valued at $194.3 million and experienced a 64% decline in stock value last year, contrasting with a 16% gain in the S&P 500 Index, although the stock has risen by 10% this year [2]. Product Development and Pipeline - Arcturus has developed the world's first approved self-amplifying mRNA Covid-19 vaccine, KOSTAIVE, and is collaborating on mRNA vaccines for Covid-19 variants and pandemic influenza [3]. - The company is advancing ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis (CF), with interim Phase 2 data showing safety and reductions in mucus burden in patients [4]. - A 12-week safety and preliminary efficacy study for ARCT-032 is planned for the first half of 2026, with a higher dose cohort being enrolled to refine the dose-response profile [5]. Additional Therapeutic Developments - Arcturus is also developing ARCT-810 for ornithine transcarbamylase (OTC) deficiency, with plans to collaborate with regulatory agencies on trial designs in 2026 [6]. - The company's mRNA platform is validated through its vaccine programs, with significant immune responses and safety profiles observed in ongoing trials for Covid-19 and pandemic influenza candidates [6].

Core Insights - Moderna has submitted regulatory filings for its seasonal influenza vaccine mRNA-1010 in the US, EU, Canada, and Australia, targeting adults aged 50 and above, with plans to commercialize by next year [1][7] - The submissions are supported by late-stage study data indicating that mRNA-1010 generates immune responses comparable to existing flu vaccines from GSK and Sanofi [2][7] - Following the announcement, Moderna's stock rose over 4%, reflecting investor optimism regarding the potential product launch [3] Regulatory and Development Updates - The recent filings may also facilitate a future resubmission of Moderna's investigational COVID-19 and influenza combination vaccine, mRNA-1083, which had previously been withdrawn due to requests for additional efficacy data [4][7] - Moderna has faced challenges, including a 32% decline in stock over the past year, contrasting with a 15% growth in the industry [5][9] - The company has experienced setbacks, including the termination of a $766 million contract for a bird flu vaccine and the failure of its CMV vaccine in a late-stage study [9][10] Market Sentiment - The latest developments are seen as part of Moderna's strategy to improve negative market sentiment surrounding its stock [8]

Core Insights - Moderna, Inc. (NASDAQ: MRNA) is recognized for its mRNA technology, which was pivotal in the development of COVID-19 vaccines, and competes with major pharmaceutical companies like Pfizer and BioNTech [1] - Jefferies has set a price target of $30 for Moderna, indicating a modest potential increase of 1.28% from its current price of $29.62 [1][5] Investment Activity - Amundi has reduced its stake in Moderna by 31.9%, selling 425,861 shares, leaving it with 909,429 shares valued at $27.5 million, which is about 0.23% of Moderna [2] - In contrast, Natixis Advisors LLC increased its stake by 70.7%, now holding 17,761 shares valued at $504,000 [2] - Charles Schwab Investment Management Inc. expanded its position in Moderna by 12.2%, owning 2,629,865 shares worth $74.6 million [3] Stock Performance - Despite the varying investment strategies, Moderna's stock price has seen a 2.03% increase, reaching $29.62 [3][5] - The stock has fluctuated between $28.87 and $29.66 today, with a 52-week high of $48.92 and a low of $22.28 [4] - Moderna's market capitalization is approximately $11.57 billion, with a trading volume of 7,159,436 shares on the NASDAQ exchange [4][5]

Core Thesis - CureVac N.V. is positioned as a credible non-U.S. mRNA platform with a strong foundation in intellectual property (IP) and process know-how, enabling it to achieve "toll-road" economics [2][4] Company Advantages - The company benefits from a robust stack of sequence engineering, codon optimization, and templating IP that enhances antigen expression and durability, along with advanced process control and quality control analytics that ensure manufacturing reproducibility [2][3] - CureVac's tight in-vitro transcription, purification, and lipid nanoparticle (LNP) formulation processes lead to lower batch variability and cost of goods sold (COGS) reductions, which are crucial for seasonal and global vaccine tenders [2][3] Strategic Partnerships - The partnership model with GSK allows CureVac to share wet-lab risks while maintaining upside potential, and its integration within the EU's academic and public health networks accelerates the transition from trials to tenders [3][4] Financial Position - Following a restructuring, CureVac has a multi-year cash runway, providing the company with the opportunity to pursue Gen-2 vaccine and oncology programs while managing IP litigation and negotiations effectively [3][4] Key Challenges - The company faces bottlenecks in sequence-to-expression translation, manufacturing scale and purity, and IP navigation, but its accumulated tacit knowledge offers a defensible position in these areas [3][4] Near-term Catalysts - Upcoming catalysts include milestones in IP monetization, Gen-2 clinical data, improvements in COGS, and progress in new partnerships [4] Market Context - CureVac's asymmetric setup, characterized by platform IP optionality, lean R&D, and strategic partnerships, presents multiple avenues for value creation in the mRNA landscape [4]

Core Insights - The core mission of the company is to leverage mRNA medicine to create significant impacts on public health, focusing on collaboration with stakeholders [1] Seasonal Vaccine Franchise - The company has established a seasonal vaccine franchise aimed at high-risk populations, with three approved products currently [2] - Positive Phase III results have been achieved for flu and flu plus COVID vaccines, while the Norovirus vaccine is in the Phase III enrollment stage [2] Oncology and Rare Disease Therapeutics - The company plans to utilize cash generated from the seasonal vaccine franchise to invest in oncology and rare disease therapeutics [1] - A significant year for oncology is anticipated in 2026, with numerous data releases expected [2]