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BioNTech SE(BNTX) - 2025 Q2 - Quarterly Report
2025-08-04 12:01
Unaudited Interim Condensed Consolidated Financial Statements [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) BioNTech reported increased revenues and reduced net loss for H1 2025, maintaining strong assets despite a shift to operating cash outflow [Statements of Profit or Loss](index=5&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Profit%20or%20Loss) BioNTech's H1 2025 revenues increased to **€443.6 million**, with operating and net losses significantly reduced Consolidated Statements of Profit or Loss (Six Months Ended June 30) | Indicator | 2025 (in millions €) | 2024 (in millions €) | | :--- | :--- | :--- | | **Revenues** | **443.6** | **316.3** | | Cost of sales | (160.2) | (118.9) | | Research and development expenses | (1,034.7) | (1,092.1) | | General and administrative expenses | (224.6) | (287.9) | | **Operating loss** | **(1,035.2)** | **(1,473.4)** | | Loss before tax | (848.1) | (1,137.6) | | **Net loss** | **(802.4)** | **(1,122.9)** | | **Basic and diluted loss per share** | **(3.33)** | **(4.67)** | [Statements of Financial Position](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Financial%20Position) As of June 30, 2025, BioNTech's total assets slightly decreased to **€21.64 billion**, primarily due to reduced current assets Consolidated Statements of Financial Position | Indicator | June 30, 2025 (in millions €) | December 31, 2024 (in millions €) | | :--- | :--- | :--- | | **Total assets** | **21,637.6** | **22,529.7** | | Cash and cash equivalents | 10,269.5 | 9,761.9 | | Total current assets | 15,929.1 | 18,803.5 | | **Total liabilities** | **3,132.5** | **3,118.6** | | **Total equity** | **18,505.1** | **19,411.1** | [Statements of Cash Flows](index=10&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for H1 2025 was **€634.2 million**, a significant shift from prior year's inflow Consolidated Statements of Cash Flows (Six Months Ended June 30) | Activity | 2025 (in millions €) | 2024 (in millions €) | | :--- | :--- | :--- | | Net cash flows from / (used in) operating activities | (634.2) | 1,309.9 | | Net cash flows from / (used in) investing activities | 1,182.4 | (2,545.8) | | Net cash flows used in financing activities | (27.1) | (30.7) | | **Net increase / (decrease) in cash and cash equivalents** | **521.1** | **(1,266.6)** | [Selected Explanatory Notes to the Financial Statements](index=11&type=section&id=Selected%20Explanatory%20Notes%20to%20the%20Financial%20Statements) Notes detail BioNTech's increased revenues, Biotheus acquisition, BMS partnership, and ongoing IP litigations [Note 3: Revenues from Contracts with Customers](index=13&type=section&id=Note%203%3A%20Revenues%20from%20Contracts%20with%20Customers) Total revenues for H1 2025 increased to **€443.6 million**, primarily driven by a **46%** rise in COVID-19 vaccine revenues Disaggregation of Revenues (Six Months Ended June 30) | Revenue Stream | 2025 (in millions €) | 2024 (in millions €) | | :--- | :--- | :--- | | COVID-19 vaccine revenues | 286.3 | 196.1 | | Other revenues | 157.3 | 120.2 | | **Total** | **443.6** | **316.3** | - The increase in COVID-19 vaccine revenues was largely driven by a **higher volume of doses sold** compared to the prior year period[34](index=34&type=chunk)[35](index=35&type=chunk) [Note 4: Income and Expenses](index=14&type=section&id=Note%204%3A%20Income%20and%20Expenses) H1 2025 saw decreased R&D and G&A expenses, with other operating results significantly improving due to the absence of prior-year contractual dispute costs - Research and development expenses decreased by **5%** for the six months ended June 30, 2025, mainly driven by the reprioritization of clinical trials towards focus programs[39](index=39&type=chunk) - General and administrative expenses decreased by **22%** for the six-month period, primarily due to a reduction in external services[40](index=40&type=chunk) - The total other operating result improved by **90%** for the six-month period, mainly because the prior year period included significant costs from contractual disputes (**€239.1 million**), which were not repeated in the current period[41](index=41&type=chunk) [Note 5: Business Combination](index=16&type=section&id=Note%205%3A%20Business%20Combination) BioNTech acquired Biotheus for **€280.1 million** on **January 31, 2025**, gaining full global rights to BNT327 - The acquisition of Biotheus closed on **January 31, 2025**, supporting BioNTech's oncology strategy by providing full global rights to the bispecific antibody BNT327[45](index=45&type=chunk)[47](index=47&type=chunk) Biotheus Acquisition Purchase Price Allocation (in millions €) | Item | Fair Value | | :--- | :--- | | Total identifiable net assets at fair value | 295.1 | | Bargain from the acquisition | (15.0) | | **Total consideration** | **280.1** | | *Details of Consideration* | | | Upfront payment | 767.8 | | Contingent consideration (milestones) | 79.6 | | Payments in connection with pre-existing relationships | (567.3) | [Note 8: Financial Assets and Financial Liabilities](index=20&type=section&id=Note%208%3A%20Financial%20Assets%20and%20Financial%20Liabilities) BioNTech formed a global strategic partnership with Bristol-Myers Squibb for BNT327, eligible for a **$1.5 billion** upfront payment - On **June 2, 2025**, BioNTech and Bristol-Myers Squibb (BMS) entered a global strategic partnership for the bispecific antibody BNT327[64](index=64&type=chunk) - Under the BMS agreement, BioNTech is eligible for a **$1.5 billion** upfront payment, **$2.0 billion** in non-contingent anniversary payments through 2028, and up to **$7.6 billion** in milestone payments[64](index=64&type=chunk) [Note 11: Contingent Liabilities](index=26&type=section&id=Note%2011%3A%20Contingent%20Liabilities) BioNTech faces numerous intellectual property disputes related to its Comirnaty vaccine, classified as contingent liabilities without provisions - The company faces an increasing number of intellectual property, product-related, and shareholder disputes, but has recorded **no provision** for any of them as of June 30, 2025, deeming them contingent liabilities[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - Key ongoing legal proceedings include patent infringement lawsuits from **Alnylam, CureVac, Moderna, Arbutus/Genevant, GSK, and Promosome**, all related to the Comirnaty vaccine[89](index=89&type=chunk)[92](index=92&type=chunk)[104](index=104&type=chunk)[117](index=117&type=chunk) [Note 13: Events after the Reporting Period](index=34&type=section&id=Note%2013%3A%20Events%20after%20the%20Reporting%20Period) Key management changes include a new CFO and CSO departure, with new patent infringement lawsuits filed by GlaxoSmithKline post-period - **Ramón Zapata** was appointed to the Management Board as **Chief Financial Officer**, effective **July 1, 2025**[129](index=129&type=chunk) - **Ryan Richardson** will step down as **Chief Strategy Officer** on **September 30, 2025**[130](index=130&type=chunk) - After the reporting period, **GlaxoSmithKline** filed new patent infringement lawsuits in **Ireland** (July 7, 2025) and the **Unified Patent Court** (July 23, 2025) concerning Comirnaty[133](index=133&type=chunk)[134](index=134&type=chunk) Operating and Financial Review and Prospects [Operating Results](index=36&type=section&id=Operating%20Results) BioNTech focuses on its oncology pipeline and next-gen COVID-19 vaccine, reporting a **40%** revenue increase and reduced net loss for H1 2025 - The company's primary focus is on **oncology**, with a strategy to address the full continuum of cancer by combining complementary treatment modalities like mRNA immunotherapies, targeted antibodies, and cell therapies[142](index=142&type=chunk)[164](index=164&type=chunk) - BioNTech is preparing for the 2025/2026 vaccination season with an **LP.8.1-adapted monovalent COVID-19 vaccine**, following recommendations from the WHO, EMA, and FDA[153](index=153&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) - Key oncology pipeline updates include: - **iNeST (autogene cevumeran):** First data from the Phase 2 trial in adjuvant colorectal cancer is expected in late 2025 or early 2026 - **FixVac (BNT111):** The Phase 2 trial in advanced melanoma met its primary endpoint of improved Objective Response Rate (ORR) - **BNT327 (bispecific antibody):** Multiple Phase 2 and Phase 3 trials are ongoing globally across various solid tumors, including lung cancer and breast cancer[168](index=168&type=chunk)[176](index=176&type=chunk)[181](index=181&type=chunk) Financial Performance Comparison (Six Months Ended June 30) | Indicator | 2025 (in millions €) | 2024 (in millions €) | Change (%) | | :--- | :--- | :--- | :--- | | Total revenues | 443.6 | 316.3 | +40% | | Research and development expenses | 1,034.7 | 1,092.1 | -5% | | General and administrative expenses | 224.6 | 287.9 | -22% | | Net loss | (802.4) | (1,122.9) | +29% (improvement) | [Liquidity and Capital Resources](index=64&type=section&id=Liquidity%20and%20Capital%20Resources) BioNTech maintained a strong liquidity position of **€16.0 billion** as of June 30, 2025, prioritizing R&D and global expansion - As of June 30, 2025, the company held a total of **€15,989.3 million** in cash, cash equivalents, and security investments[290](index=290&type=chunk) Summary of Cash Flows (Six Months Ended June 30) | Activity | 2025 (in millions €) | 2024 (in millions €) | | :--- | :--- | :--- | | Operating activities | (634.2) | 1,309.9 | | Investing activities | 1,182.4 | (2,545.8) | | Financing activities | (27.1) | (30.7) | - The capital allocation strategy focuses on **advancing the oncology pipeline**, **developing next-gen COVID-19 vaccines**, **building a global development organization**, and **enhancing capabilities through acquisitions and infrastructure investments**[288](index=288&type=chunk)[289](index=289&type=chunk) [Risk Factors](index=69&type=section&id=Risk%20Factors) BioNTech faces significant risks including declining COVID-19 vaccine demand, patent litigations, clinical development uncertainties, and manufacturing challenges - A significant risk is the expected **decrease in demand for the COVID-19 vaccine**, which will impact revenue that is currently heavily dependent on these sales[312](index=312&type=chunk)[315](index=315&type=chunk) - The company faces **numerous patent litigations** from competitors like Moderna, CureVac, and others, which could result in substantial liabilities and negatively affect operations[314](index=314&type=chunk)[612](index=612&type=chunk) - Clinical development involves a **lengthy, expensive, and uncertain process**, and the novel nature of mRNA drug development carries **substantial regulatory risks** due to limited regulatory experience[316](index=316&type=chunk)[447](index=447&type=chunk)[461](index=461&type=chunk) - Manufacturing of novel and complex mRNA-based products presents **challenges in scaling, product release, shelf life, and supply chain management**, which could delay or halt production[316](index=316&type=chunk)[522](index=522&type=chunk)
BioNTech SE(BNTX) - 2025 Q2 - Earnings Call Presentation
2025-08-04 12:00
Financial Performance - Second quarter 2025 revenues reached €261 million, compared to €129 million in the second quarter of 2024[61] - First half 2025 revenues totaled €444 million, an increase from €316 million in the first half of 2024[61] - The company reported a net loss of €387 million for the second quarter of 2025, compared to a net loss of €808 million for the same period in 2024[61] - Research and Development expenses for the second quarter of 2025 were €509 million, compared to €585 million for the second quarter of 2024[61] - Cash and cash equivalents plus security investments reached approximately €160 billion as of June 30, 2025[12,61] Strategic Collaboration - BioNTech and Bristol Myers Squibb (BMS) entered into a strategic collaboration for BNT3271, with an upfront cash payment of $15 billion expected in Q3 2025[12,62] - The collaboration with BMS includes non-contingent anniversary cash payments of $20 billion from 2026 to 2028[62] - Potential development, regulatory, and commercial milestone cash payments from BMS could reach up to $76 billion[62] Pipeline Development - A Phase 2 study of BNT3271 combined with chemotherapy in 1L ES-SCLC showed an objective response rate (ORR) of 854% and a median overall survival (OS) of 168 months[29] - In a Phase 1b/2a study, BNT3271 monotherapy in 1L NSCLC (EGFR & ALK WT) showed an ORR of 47% and a median PFS of 136 months[34] - A Phase 1/2 study of BNT3271 combined with chemotherapy in 1L TNBC showed an ORR of 738% and a median PFS of 135 months[35]
BioNTech二季度亏损收窄 新冠疫苗收入实现增长
Ge Long Hui A P P· 2025-08-04 11:54
格隆汇8月4日|德国生物科技公司BioNTech公布财报显示,第二季度营收增长超过一倍,达2.6亿欧元 (约合3亿美元),这得益于新冠疫苗带来的收入增长。该公司季度净亏损为3.87亿欧元,较去年同期 的8亿欧元净亏损大幅收窄。 ...
BioNTech财报亏损收窄,新冠疫苗收入实现增长
Di Yi Cai Jing· 2025-08-04 11:39
该公司第二季度净亏损为3.87亿欧元,较去年同期的8亿欧元净亏损大幅收窄。 8月4日,德国生物科技公司BioNTech公布财报显示,第二季度营收增长超过一倍,达2.6亿欧元(约合3 亿美元),这得益于新冠疫苗带来的收入增长。该公司季度净亏损为3.87亿欧元,较去年同期的8亿欧 元净亏损大幅收窄。 ...
BioNTech财报亏损收窄 新冠疫苗收入实现增长
Di Yi Cai Jing· 2025-08-04 11:36
(文章来源:第一财经) 8月4日,德国生物科技公司BioNTech公布财报显示,第二季度营收增长超过一倍,达2.6亿欧元(约合3 亿美元),这得益于新冠疫苗带来的收入增长。该公司季度净亏损为3.87亿欧元,较去年同期的8亿欧 元净亏损大幅收窄。 ...
BioNTech Announces Second Quarter 2025 Financial Results and Corporate Update
Globenewswire· 2025-08-04 10:45
Core Insights - BioNTech reported significant advancements in its oncology strategy, including collaborations and acquisitions aimed at enhancing its product pipeline and capabilities [2][6][30] - The company experienced a substantial increase in revenues for the second quarter of 2025, driven primarily by its COVID-19 vaccine collaboration [3][4] - BioNTech's financial position remains strong, with substantial cash reserves and expected cash inflows from strategic partnerships [10][11][14] Financial Performance - Revenues for Q2 2025 reached €260.8 million, up from €128.7 million in Q2 2024, while total revenues for the first half of 2025 were €443.6 million compared to €316.3 million in the prior year [3][4] - The net loss for Q2 2025 was €386.6 million, a significant reduction from a net loss of €807.8 million in Q2 2024, with a total net loss of €802.4 million for the first half of 2025 compared to €1,122.9 million in the same period last year [7][8] - Basic and diluted loss per share improved to €1.60 for Q2 2025 from €3.36 in Q2 2024, and for the first half of 2025, it was €3.33 compared to €4.67 in the prior year [8][41] Research and Development - R&D expenses for Q2 2025 were €509.1 million, down from €584.6 million in Q2 2024, with total R&D expenses for the first half of 2025 at €1,034.7 million compared to €1,092.1 million in the previous year [4][5] - The company is focusing on its oncology pipeline, including the development of BNT327, a bispecific antibody candidate, and has initiated several clinical trials for various cancer treatments [6][23][27] Strategic Developments - BioNTech entered a collaboration with Bristol Myers Squibb (BMS) for the co-development of BNT327, which includes an upfront cash payment of $1.5 billion and potential milestone payments totaling up to $7.6 billion [10][11][12] - The acquisition of CureVac is expected to enhance BioNTech's capabilities in mRNA technology, complementing its existing product offerings [2][6][30] - The company has received approval for a new variant-adapted COVID-19 vaccine, with preparations for launch underway [6][22] Financial Guidance - BioNTech reaffirmed its revenue guidance for the full year 2025, expecting revenues to be between €1,700 million and €2,200 million, with a focus on late-stage development and commercialization in oncology [14][16] - Planned expenses for 2025 include R&D expenses of €2,600 million to €2,800 million and SG&A expenses of €650 million to €750 million [15][16]
Pandemic darlings Moderna, BioNTech are now on two different paths
CNBC· 2025-07-31 11:00
Core Insights - The Covid-19 pandemic significantly elevated the profiles of Moderna and BioNTech, but the two companies have since diverged in their strategic directions and stock performances [3][5]. Company Strategies - Moderna has focused on expanding its mRNA pipeline, investing in vaccines for flu, RSV, and other viruses, while BioNTech has diversified into cancer technologies and other areas [4][6][13]. - BioNTech's strategy includes acquiring promising cancer technologies, such as a bispecific antibody targeting PD-L1 and VEG-F, which could rival existing successful cancer drugs like Merck's Keytruda [14][15]. Financial Performance - Both companies generated approximately $45 billion in sales from Covid vaccines, with each earning around $20 billion since late 2020 [3]. - Moderna currently holds about $8.4 billion in cash, while BioNTech has €15.9 billion (approximately $18.2 billion) [4]. Stock Performance - Over the past year, Moderna's stock has decreased by about 72%, whereas BioNTech's shares have increased by nearly 29% [5]. Future Outlook - Moderna is seeking FDA approval for an mRNA flu shot and is focused on a Phase 3 trial for a personalized cancer treatment for melanoma, with potential data release as early as next year [17][18]. - BioNTech is awaiting results from its own studies and ongoing Phase 3 trials, which could impact its stock performance significantly [16][18].
BioNTech SE Sponsored ADR (BNTX) Is Up 4.81% in One Week: What You Should Know
ZACKS· 2025-07-30 17:00
Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Group 1: Company Overview - BioNTech SE Sponsored ADR (BNTX) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The company has a Zacks Rank of 1 (Strong Buy), suggesting a favorable outlook based on historical performance metrics [4] Group 2: Performance Metrics - Over the past week, BNTX shares increased by 4.81%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 1.8% [6] - In the last quarter, BNTX shares rose by 17.67%, and over the past year, they increased by 28.52%, while the S&P 500 saw gains of 14.96% and 18.01%, respectively [7] Group 3: Trading Volume - BNTX's average 20-day trading volume is 603,221 shares, which serves as a bullish indicator when combined with rising stock prices [8] Group 4: Earnings Outlook - In the past two months, five earnings estimates for BNTX have been revised upwards, with no downward revisions, leading to an increase in the consensus estimate from -$6.68 to -$3.91 [10] - For the next fiscal year, four estimates have also moved higher, indicating positive sentiment regarding future earnings [10] Group 5: Conclusion - Given the strong performance metrics and positive earnings outlook, BNTX is positioned as a promising investment opportunity with a Momentum Score of A [12]
从“扫货”管线到争当IPO基石:外资加码中国创新药
Di Yi Cai Jing· 2025-07-29 10:31
Core Insights - The Chinese pharmaceutical industry is experiencing a resurgence after three years of stagnation, driven by high-value licensing deals from multinational pharmaceutical companies [1][2] - There is a significant interest from overseas investors in Chinese biopharmaceutical companies, with a notable increase in licensing agreements and IPO activities [2][8] - The trend of "licensing out" Chinese drug candidates to foreign companies is becoming more common, providing Chinese firms with milestone payments and a share of sales revenue [4][6] Group 1: Market Dynamics - As of mid-July, approximately 288 companies are waiting for IPOs in Hong Kong, many of which are biopharmaceutical firms seeking to list under the 18A rule [1][8] - The Hong Kong medical sector has seen a 54% increase this year, significantly outperforming the MSCI China Index, which rose by 17% [8] - The average price-to-earnings (PE) ratio for the sector is around 30 times, placing it in the 15th percentile of its valuation range over the past five years [8] Group 2: Investment Trends - U.S. investment banks are playing a crucial role in facilitating these licensing deals and IPOs, with cornerstone investors contributing 42% of IPO financing this year, two-thirds of which comes from overseas [1][12] - The trend of U.S. pharmaceutical companies seeking to lower costs through partnerships with Chinese firms is expected to continue, especially in light of U.S. drug pricing policies [2][6] Group 3: Licensing Agreements - The number of licensing transactions from China has increased significantly, with 35 deals in 2023 and projected to reach 43 in 2024, alongside a total upfront payment of $2.957 billion in 2023 [3][6] - Notable licensing agreements include Akeso's ivonescimab, which was licensed to Summit Therapeutics for a total value of $5 billion, marking one of the largest overseas licensing deals in Chinese biopharmaceutical history [7][6] Group 4: Future Outlook - Chinese biopharmaceutical companies are increasingly able to produce globally recognized clinical data, particularly in competitive fields like oncology and immunology [2][6] - The shift from merely selling drug pipelines to achieving global commercialization is essential for the future growth of Chinese pharmaceutical companies [13][15] - There is a need for Chinese firms to enhance their innovation capabilities and international execution to compete effectively on a global scale [14][15]
Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-Adapted COVID-19 Vaccine in the European Union
Globenewswire· 2025-07-25 06:30
Core Viewpoint - Pfizer and BioNTech have received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY LP.8.1, aimed at preventing COVID-19 in individuals aged 6 months and older, in response to the evolving SARS-CoV-2 variants [1][2][6]. Group 1: Vaccine Development and Approval - The LP.8.1-adapted vaccine is designed to improve immune responses against multiple circulating SARS-CoV-2 lineages, including XFG and NB.1.8.1, compared to previous vaccine formulations [2][6]. - The European Commission is expected to make a final decision on the marketing authorization soon, with manufacturing already initiated to ensure supply readiness for the upcoming vaccination season [1][6]. - Over a billion doses of the Pfizer-BioNTech COVID-19 vaccine have been administered globally, demonstrating a favorable safety and efficacy profile supported by extensive data [6]. Group 2: Regulatory and Market Context - The CHMP's recommendation is based on a comprehensive body of evidence, including clinical, non-clinical, and real-world data, affirming the safety and efficacy of the vaccine [2][4]. - The companies are actively monitoring the epidemiology of COVID-19 to adapt to global public health needs and have submitted data for the updated vaccine to regulatory authorities worldwide [3][4]. - The LP.8.1-adapted vaccine will be available for individuals aged 6 months and older upon authorization by the European Commission [6].