BioNTech (BNTX) Q4 2024 Earnings Call March 10, 2025 08:17 PM 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 DirectorTazeen Ahmad - MD - US Equity ResearchHarry Gillis - Vice President - Pharmaceuticals Equity ResearchCory Kasimov - Senior Managing Director Conference Call Participa ...

BioNTech SE (NASDAQ:BNTX) Q4 2024 Earnings Conference Call March 10, 2025 8:00 AM ET Company Participants Michael Horowicz - Director, Investor Relations Ugur Sahin - Co-Founder and Chief Executive Officer Ozlem Tureci - Co-Founder and Chief Medical Officer Jens Holstein - Chief Financial Officer Ryan Richardson - Chief Strategy Officer Conference Call Participants Daina Graybosch - Leerink Partners Akash Tewari - Jefferies Chris Shibutani - Goldman Sachs Tazeen Ahmad - Bank of America Securities Terence Fl ...

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech's expected revenues and net profit/(loss) related to sales of BioNTech's COVID-19 vaccine, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech's collaboration partners, particularly for those figures that are derived from ...

BioNTech SE exceeded earnings expectations with strong oncology pipeline development, despite reduced vaccine revenue.Biopharmaceutical company BioNTech SE (BNTX -1.85%) reported fourth-quarter and full-year 2024 earnings on Monday, March 10, that topped analysts' consensus expectations. It reported revenue of 1.19 billion euros, ahead of estimates for 1.14 billion but down nearly 43% from the prior year's quarter. Earnings per share (EPS) stood at 1.08 euros against the expected 0.42 euros, a significant o ...

COVID-19 Vaccine Demand and Revenue - Demand for the COVID-19 vaccine is expected to decrease in the near future, impacting revenue heavily reliant on vaccine sales [30]. - The company has experienced significant reductions in demand for COVID-19 vaccination as the virus has entered an endemic stage [31]. - Future revenues from the COVID-19 vaccine are expected to decrease as overall demand for vaccination wanes, prompting the company to invest heavily in research and development to diversify its therapeutic area footprint [100]. - The company continues to generate revenue from sales of its COVID-19 vaccine, with expectations to maintain revenue, although future demand is uncertain due to factors like new virus variants and public health measures [91]. - The company faces risks related to catastrophic global events, including natural disasters and political crises, which could adversely affect operations and supply chains [129]. Regulatory and Compliance Risks - The company is subject to ongoing regulatory oversight, which may reveal new safety issues affecting commercialization efforts [41]. - The company faces significant risks related to regulatory compliance, which could lead to product recalls, suspensions, or fines if not adhered to [43]. - The overall regulatory approval pathway for the company's product candidates is complex, expensive, and lengthy, with no guarantee of success [167]. - The company acknowledges that mRNA drug development carries substantial clinical and regulatory risks, with limited prior approvals for mRNA immunotherapies [147]. - The company faces challenges in obtaining favorable pricing and reimbursement for its products in various jurisdictions, particularly in the European Union where pricing is subject to governmental control [89]. Financial Performance and Market Conditions - Reported commercial revenue is based on preliminary estimates from Pfizer, which may change and affect financial results [35]. - The market price of the company's ADSs may decline if revenues or financial metrics do not meet investor expectations [34]. - The company has incurred tax losses in Germany and the United States, which may limit the ability to utilize net operating losses (NOLs) and tax credits until assessed by tax authorities [104]. - The company anticipates significant and increasing operating expenses as it continues to expand research, clinical trials, and manufacturing capabilities [101]. - The company may require substantial additional financing to achieve its goals, with potential delays or reductions in product development if capital is not obtained on acceptable terms [109]. Product Development and Commercialization Challenges - Successful commercialization of product candidates is heavily dependent on obtaining adequate reimbursement from governmental and private payors [44]. - Market acceptance of products is uncertain and depends on factors such as efficacy, pricing, and third-party reimbursement availability [74]. - The company faces challenges in scaling up manufacturing processes for mRNA therapies, which may lead to batch failures and delays in clinical trials [160]. - Clinical trials are lengthy and expensive, with potential delays due to various factors, including patient recruitment difficulties and unforeseen events [161]. - The company is dependent on the successful development and regulatory approval of product candidates, with the marketing approval process being expensive and time-consuming [138]. Competition and Market Dynamics - Competition in the COVID-19 vaccine market is intense, with several manufacturers having greater resources and experience [56]. - The company’s COVID-19 vaccine is sensitive to storage conditions, which could lead to supply chain challenges and affect market competitiveness [59]. - The market opportunities for some product candidates may be limited due to the rarity of diseases targeted, impacting profitability [67]. - Future profitability depends on the company's ability and that of its collaborators to penetrate global markets, facing regulatory burdens and uncertainties [72]. - The company faces significant risks in clinical trials, with many product candidates potentially failing to demonstrate safety and efficacy, impacting future development efforts [42]. Insurance and Liability Concerns - The company has received product liability claims related to the COVID-19 vaccine and expects to continue facing such claims [41]. - The company has clinical trial and product liability insurance, but coverage may not be adequate as the pipeline moves towards commercialization [206]. - The company maintains insurance coverage for various risks, but increasing costs and potential inadequacies in coverage could adversely affect financial condition [133]. - Product liability claims related to the COVID-19 vaccine have been received, with expectations for additional claims in the future, which could incur substantial liabilities [205]. Environmental, Social, and Governance (ESG) Factors - The company has set near-term science-based emissions reduction targets for its operations and supply chain, validated by the Science Based Targets initiative (SBTi) in early February 2024 [214]. - Companies are increasingly judged on their ESG performance, and failure to comply with standards could have a material adverse effect on reputation and financial condition [218]. - The company faces unexpected costs and reputational harm due to evolving ESG expectations, which could adversely affect its financial condition and cash flows [212]. - Increasing regulatory requirements regarding human rights risks are being addressed, including compliance with the German LkSG and potential EU legislation [215]. - The company is subject to heightened ESG-related transparency and reporting obligations, including the EU Corporate Sustainability Reporting Directive and potential SEC rules [216].

Financial Performance - BioNTech is expected to report fourth-quarter earnings of $0.25 per share, a significant decrease from $1.90 per share in the same period last year [1] - The company projects quarterly revenue of $1.15 billion, down from $1.48 billion a year earlier [1] Regulatory Developments - The U.S. FDA has placed a clinical hold on BioNTech's Investigational New Drug application for the RNA-based vaccine BNT165e, which is intended for malaria prevention [2] - Following the FDA's announcement, BioNTech shares fell by 3.4%, closing at $110.83 [2] Analyst Ratings - Wells Fargo analyst Mohit Bansal initiated coverage with an Overweight rating and a price target of $172 [4] - Canaccord Genuity analyst William Maughan maintained a Buy rating and slightly increased the price target from $171 to $171.44 [4] - JP Morgan analyst Jessica Fye maintained a Neutral rating and reduced the price target from $124 to $122 [4] - Evercore ISI Group analyst Cory Kasimov upgraded the stock from In-Line to Outperform, raising the price target from $110 to $125 [4] - Morgan Stanley analyst Terence Flynn upgraded the stock from Equal-Weight to Overweight, increasing the price target from $93 to $145 [4]

Group 1 - The FDA's vaccine advisory committee meeting scheduled for March 13 has been canceled, marking the second disruption since Robert F. Kennedy Jr. became the Health and Human Services secretary [1][2][5] - The agenda for the canceled meeting was to select influenza virus strains for the 2025-26 flu season, and the cancellation suggests that strain selection will not occur this year due to the six-month production timeline [2][3] - The Advisory Committee on Immunization Practices (ACIP) also postponed a three-day meeting that was supposed to discuss various vaccines, including a new meningitis vaccine and shots for Chikungunya, RSV, and influenza [5] Group 2 - The ongoing 2024-25 flu season has reported a total of 19,000 deaths, including 86 children, making it one of the worst seasons in recent years according to CDC data [6]

Group 1 - Stocks of COVID vaccine manufacturers, including Moderna, Pfizer, Novavax, and BioNTech, experienced an increase due to reports of a new bat coronavirus discovered in China [1][5] - The newly identified coronavirus, HKU5-Cov-2, has the potential to be transmitted to humans and belongs to the same family as SARS-CoV-2, which caused the COVID-19 pandemic [2] - HKU5-Cov-2 shares similarities with viruses causing MERS and exhibits symptoms such as fever, cough, and breathlessness, but has not yet been found in humans [3] Group 2 - The rise in stock prices for Moderna (5.3%), Pfizer (1.5%), Novavax (0.9%), and BioNTech (1.8%) reflects market anticipation of potential future demand for vaccines due to the new virus [5] - Despite the potential for HKU5-Cov-2 to infect humans, the likelihood of it causing a pandemic is considered low due to its lower efficiency in binding to human ACE2 compared to SARS-CoV-2 [6] - Current Zacks Rank indicates that Moderna, Novavax, and Pfizer hold a rank of 3 (Hold), while BioNTech has a rank of 2 (Buy) [7]

Core Viewpoint - BioNTech SE will announce its financial results for Q4 and full year 2024 on March 10, 2025, and will host a conference call and webcast for stakeholders to discuss these results and provide a corporate update [1]. Group 1: Financial Results Announcement - The financial results for Q4 and the full year 2024 will be disclosed on March 10, 2025 [1]. - A conference call and webcast will take place at 8:00 a.m. EDT (1:00 p.m. CET) on the same day [1]. Group 2: Accessing the Conference Call - Participants can register for the live conference call via a provided link, with dial-in numbers and a PIN sent after registration [2]. - It is recommended to register at least one day in advance for the call [2]. - The slide presentation and audio of the webcast will be accessible through a specified link [2]. Group 3: Company Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and serious diseases [4]. - The company utilizes a variety of computational discovery and therapeutic drug platforms for rapid biopharmaceutical development [4]. - BioNTech's oncology product portfolio includes mRNA-based therapies, CAR T cells, protein-based therapeutics, and small molecules [4]. - The company is also developing multiple mRNA vaccine candidates for infectious diseases alongside its oncology pipeline [4]. - BioNTech has established collaborations with various global pharmaceutical companies, including Pfizer and Genentech [4].

Core Viewpoint - BioNTech SE has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][4]. Earnings Estimates and Stock Ratings - The Zacks rating system is primarily based on a company's changing earnings picture, with the Zacks Consensus Estimate tracking EPS estimates from sell-side analysts [2]. - The Zacks rating upgrade for BioNTech reflects an optimistic earnings outlook, likely leading to increased buying pressure and a rise in stock price [4][6]. Impact of Earnings Estimate Revisions - Changes in a company's future earnings potential, as shown by earnings estimate revisions, are strongly correlated with near-term stock price movements, particularly due to institutional investors' reliance on these estimates for fair value calculations [5][7]. - Rising earnings estimates for BioNTech suggest an improvement in its underlying business, which should encourage investors to drive the stock price higher [6]. Zacks Rank System Performance - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [8]. - BioNTech's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10][11]. Current Earnings Estimates for BioNTech - For the fiscal year ending December 2024, BioNTech is expected to earn -$3.80 per share, reflecting a year-over-year change of -191.6%, although analysts have raised their estimates by 1.4% over the past three months [9].