Core Insights - Pfizer and BioNTech received FDA approval for their LP.8.1-adapted monovalent COVID-19 vaccine for adults aged 65 and older, and for individuals aged 5 to 64 with underlying health conditions [1][2][3] Group 1: FDA Approval and Vaccine Details - The FDA's approval is based on extensive evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including data from clinical trials for children aged 5 to 11 [2] - The LP.8.1-adapted vaccine is designed to generate improved immune responses against multiple circulating SARS-CoV-2 sublineages compared to previous vaccine adaptations [2][4] - The LP.8.1 sublineage was selected following FDA guidance, marking it as the preferred option for the upcoming fall 2025 vaccination season [3][6] Group 2: Distribution and Supply - Shipping of the LP.8.1-adapted vaccine will commence immediately, ensuring availability in pharmacies, hospitals, and clinics across the U.S. [3][6] - To date, 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed globally, demonstrating a favorable safety and efficacy profile [4] Group 3: Company Background - Pfizer and BioNTech utilize BioNTech's proprietary mRNA technology for their COVID-19 vaccines, with BioNTech holding marketing authorization in various regions [4][18] - BioNTech is also engaged in developing a diverse portfolio of oncology product candidates alongside its COVID-19 vaccine efforts [18]

Core Insights - CureVac NV has reached a settlement with Pfizer and BioNTech regarding long-term patent disputes over mRNA vaccines, resulting in a payment of up to $500 million to its former partner GlaxoSmithKline (GSK) and a 1% royalty on future vaccine sales [1][2] - The settlement comes as BioNTech seeks to acquire CureVac for approximately $1.25 billion, with GSK set to receive an upfront payment of $370 million and an additional $130 million upon completion of the acquisition [1] - GSK, which previously collaborated with CureVac on COVID-19 vaccine development, will continue to pursue legal action against BioNTech and Pfizer for alleged patent infringements despite the settlement [2] Group 1 - The settlement resolves ongoing litigation between CureVac, Pfizer, and BioNTech but does not conclude GSK's legal actions [2] - GSK had previously restructured its partnership with CureVac, agreeing to pay up to $1.4 billion for rights to mRNA flu and COVID-19 vaccines developed by CureVac [1] - GSK will receive a 1% royalty on sales of flu, COVID-19, and related combination mRNA vaccines sold by Pfizer-BioNTech in the U.S. and an additional 1% on sales outside the U.S. after BioNTech's acquisition of CureVac [1]

Financial Performance - BioNTech reported a narrower second-quarter per-share loss of $1.82 (1.60 euros), compared to a loss of 3.36 euros a year ago, beating the consensus loss estimate of $2.42 per share [1] - The company achieved sales of $295.69 million (260.8 million euros), significantly higher than the 128.7 million euros reported a year ago and exceeding the consensus estimate of $147.90 million [1] Future Guidance - BioNTech reaffirmed its fiscal year 2025 revenue guidance of 1.7 billion to 2.2 billion euros, compared to the consensus estimate of 2.05 billion euros, with revenue expected to be concentrated in the last three to four months of the fiscal year [2] Strategic Developments - The CEO of BioNTech, Ugur Sahin, stated that the company is advancing towards becoming a multiproduct biotechnology company by strengthening its oncology strategy [2] Stock Performance - Following the earnings announcement, BioNTech shares increased by 0.9%, trading at $111.05 [2] Analyst Ratings - B of A Securities analyst Tazeen Ahmad maintained a Buy rating on BioNTech and raised the price target from $126 to $134 [5] - Wells Fargo analyst Mohit Bansal maintained an Overweight rating but lowered the price target from $170 to $150 [5]

Financial Data and Key Metrics Changes - For Q2 2025, total revenues reached approximately €261 million, a significant increase from €129 million in Q2 2024, primarily driven by higher revenues from the COVID-19 vaccine collaboration [40] - Research and development expenses decreased to approximately €585 million from €709 million in the prior year, reflecting a reprioritization of clinical trials [41] - The company reported a net loss of €387 million for Q2 2025, compared to a net loss of €88 million in the same period last year [42] - Basic and diluted loss per share improved to €1.6 from €3.3 year-over-year [42] - Cash and cash equivalents stood at €16 billion, providing flexibility for long-term strategy execution [42] Business Line Data and Key Metrics Changes - The company is focusing on two priority pan-tumor programs: mRNA cancer immunotherapies and bispecific antibody BNT327, with significant investments in clinical development [9][10] - The acquisition of BioThese has fully integrated BNT327 into the pipeline, enhancing its clinical development capabilities [10] - The collaboration with Bristol Myers Squibb (BMS) aims to establish BNT327 as a new standard of care across multiple tumor types [11][16] Market Data and Key Metrics Changes - The company is preparing for the global commercial rollout of a new variant-adapted COVID-19 vaccine, pending regulatory approvals, indicating ongoing market engagement [13] - The partnership with the UK government aims to invest up to £1 billion over the next decade to accelerate clinical trials for personalized mRNA immunotherapies [13] Company Strategy and Development Direction - The overarching vision is to build an immunotherapy powerhouse and become a fully integrated biopharmaceutical company with multiple approved therapies [7] - The strategy includes developing combination therapies that address various cancer stages, focusing on both early and late-stage cancers [8] - The company is enhancing its commercial infrastructure and manufacturing capabilities to support future launches in key markets [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of BNT327 to improve patient outcomes in high unmet medical need areas, with ongoing clinical trials expected to yield meaningful data [20][21] - The company anticipates lower COVID-19 vaccination rates compared to previous years but remains optimistic about maintaining market share and pricing [47] - Future growth is expected to be driven by the oncology pipeline and the ongoing development of combination therapies [49] Other Important Information - The company reaffirmed its financial guidance for 2025, expecting revenues between €1.7 billion and €2.2 billion, with R&D expenses projected between €2.6 billion and €2.8 billion [46] - The collaboration with BMS is expected to significantly strengthen the company's cash position and P&L for the coming years [43][45] Q&A Session Summary Question: Clarity on vaccine development and vaccination rates - Management acknowledged lower vaccination rates but emphasized the ongoing priority of the COVID-19 vaccine business alongside oncology development [56][57] Question: Details on BNT327 trial doses and data release - Management confirmed that details on doses for the Phase II portion will be shared later this year, with top-line data expected before year-end [62][63] Question: BNT327 in frontline triple-negative breast cancer - Management highlighted the potential of BNT327 in combination with ADCs and the encouraging data generated so far [66] Question: R&D spending post-Bristol collaboration - Management indicated that R&D spending will increase in priority areas while decreasing in less prioritized programs [71] Question: COVID-19 vaccination revenue guidance - Management expects lower vaccination rates but maintains that pricing and market share will remain stable [78]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 reached approximately €261 million, a significant increase from €129 million in Q2 2024, primarily driven by higher revenues from the COVID-19 vaccine collaboration [41] - Research and development expenses decreased to approximately €585 million in Q2 2025 from €709 million in the prior year, reflecting a reprioritization of clinical trials [42] - The net loss for Q2 2025 was €387 million, compared to a net loss of €88 million in Q2 2024, with a basic and diluted loss per share of €1.6 compared to €3.3 in the prior year [43] Business Line Data and Key Metrics Changes - The company is focusing on two priority pan-tumor programs: mRNA cancer immunotherapies (Sigvec and INEST) and bispecific antibody BNT327, which are expected to enhance patient outcomes across multiple cancer indications [8][10] - The acquisition of BioThese has fully integrated BNT327 into the pipeline, with a global co-development collaboration with BMS initiated to accelerate its clinical development [10][14] Market Data and Key Metrics Changes - The company anticipates lower COVID-19 vaccination rates in the U.S. compared to the previous year, estimating around 20% vaccination rates, which may impact revenue guidance [47][58] - Despite lower vaccination rates, the company expects to maintain similar market share and pricing as compared to 2024 [47] Company Strategy and Development Direction - The overarching vision is to build an immunotherapy powerhouse and become a fully integrated biopharmaceutical company with multiple approved therapies, focusing on combination therapies to improve cancer treatment outcomes [7] - The company is investing significantly in clinical development and commercial infrastructure to support future launches in key markets [9][10] - A strategic transaction to acquire QVAC aims to enhance capabilities in mRNA design and manufacturing [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of BNT327 to establish new standards of care across multiple tumor types, with ongoing clinical trials expected to yield meaningful data [19][20] - The company is preparing for the global commercial rollout of a new variant-adapted COVID-19 vaccine, pending regulatory approvals, and has expanded partnerships to enhance R&D activities [13][14] Other Important Information - The company maintains a strong financial position with €16 billion in cash and securities, providing flexibility to pursue long-term strategies [43] - The anticipated financial implications of the collaboration with BMS include an upfront cash payment of $1.5 billion and potential milestone payments totaling up to $7.6 billion [45][46] Q&A Session Summary Question: Clarity on vaccine development and future vaccination rates - Management acknowledged lower vaccination rates and emphasized the continued priority of the COVID-19 vaccine business while exploring next-generation concepts and combination vaccines [56][58] Question: Details on the BNT327 trial and data release timing - Management confirmed that details on doses for the Phase II portion of the BNT327 trial will be discussed later this year, with top-line data expected before year-end [64][65] Question: Insights on BNT327 in frontline TNBC and ADC combinations - Management highlighted the potential of BNT327 in triple-negative breast cancer (TNBC) and ongoing studies to evaluate its efficacy in combination with ADCs [67][68] Question: R&D spending evolution post-Bristol collaboration - Management indicated that R&D spending will increase in priority areas, particularly for late-stage programs, while decreasing in non-priority areas [71][73] Question: Assumptions on lower vaccination rates and revenue guidance - Management reiterated expectations for lower vaccination rates but maintained revenue guidance, anticipating a phased revenue recognition towards the end of the year [78][80]

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)

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]

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。 ...

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。 ...

（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。 ...