Third Quarter 2020
Total Page:16
File Type:pdf, Size:1020Kb
March 31, 2020 Third Quarter 2020 Corporate update and financial results November 10, 2020 Forward-looking statements Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, including the Company's views with respect to the potential for mRNA and other pipeline therapeutics; BioNTech's efforts to combat COVID-19; the collaborations between BioNTech and Pfizer and Fosun to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our continuing Phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data for BNT162, BNT311 and our other product candidates, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any potential approval or Emergency Use Authorization with respect to our BNT162 program; the timing for submission of BNT162 manufacturing data to the FDA; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021 and orders received to-date; the planned next steps in BioNTech's pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech's product candidates and expectations for data announcements with respect to BioNTech's product candidates; BioNTech's expectations with respect to interactions with regulatory authorities such as FDA and EMA, including the potential approval of BioNTech's or its collaborators' current or future drug candidates; expected royalty and milestone payments in connection with BioNTech's collaborations; BioNTech's anticipated cash usage for fiscal year 2020 and beyond; the creation of long-term value for BioNTech shareholders; and the impact of COVID-19 on clinical trials and business operations, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "expects," "plans," "potential," "target," "continue" and variations of these words or similar expressions are intended to identify forward-looking statements. Such statements are based on the current beliefs and assumptions of the management team of BioNTech and on the information currently available to the management team of BioNTech and are subject to change. The Company will not necessarily inform you of such changes. These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause the Company's actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the Company's ability to discover and develop its novel product candidates and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates; actions of the Company's collaborators regarding continued product development and product commercialization; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical trials or the ability of the Company to obtain marketing authorization for its product candidates; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of our ongoing BNT162 trial or in larger, more diverse populations upon commercialization; the Company's ability to obtain, maintain and protect its intellectual property; the Company's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; competition from others using technology similar to the Company's and others developing products for similar uses; the Company's ability to manage operating expenses; the Company's ability to obtain additional funding to support its business activities and establish and maintain its existing and future collaborations and new business initiatives; the Company's dependence on collaborators and other third parties for development, manufacture, marketing, sales and distribution of products; the outcome of litigation; and unexpected expenditures. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements. The mRNA vaccines and other product candidates discussed in this slide presentation are investigational products being developed by BioNTech and its collaborators and are not currently approved by the FDA, EMA or any other regulatory authority. 2 Agenda • Q3 Highlights • BNT162 (COVID-19 vaccine program) • Oncology Pipeline Update • Financial Update and Outlook 3 Q3 2020 Highlights • Achieved Success in First Interim Analysis from Phase 3 Study BNT 162 COVID-19 Vaccine Program • No serious adverse events with mild to moderate tolerability profile observed to date • Rolling submissions ongoing to EMA, MHRA (UK) and Health Canada • On track for Emergency Use Authorization submission to FDA as early as the third week of November • Initiated clinical trials in Japan and China to support potential local approval • Acquired GMP facility in Marburg, Germany intended to increase production capacity in 2021 • Commercial launch planning underway with global partners Pfizer and Fosun Pharma • Promising early Phase 1 data for Next Gen Immunomodulator (BNT311) at SITC 2020 Oncology Pipeline • Early Phase 1 data presented for BNT131 (SAR441000) at SITC and BNT114 at ESMO • IND approval granted for randomized Phase 2 trial of iNeST (BNT122) in adjuvant CRC • First patient dosed in Phase 1/2a trial of BNT411 in SCLC Financial Update • Closed equity and debt financings and secured grant commitments of approximately 1 and Outlook $1.2 billion (€1.0 billion) in combined gross proceeds, resulting in net cash receipts of $0.8 billion1 (€0.6 billion) in the third quarter • Cash position of $1.2 billion1 (€1.0 billion) on the balance sheet at end of Q3 2020 1 4 Amounts translated using the exchange rate published by the German Central Bank (Deutsche Bundesbank) in effect as of the date of transaction, if closed; otherwise as of September 30, 2020 Agenda • Q3 Highlights • BNT162 (COVID-19 vaccine program) • Oncology Pipeline Update • Financial Update and Outlook 5 COVID-19 vaccine development timeline Primary Efficacy Endpoint: Initiated To evaluate the efficacy of Pivotal Phase prophylactic BNT162b2 against Candidate/ 2b / 3 Trial confirmed COVID-19 in participants Dose July 27, 2020 Start with (and without) evidence of Selection with up to 44,000 infection before vaccination BNT162b2 subjects COVID-19 mRNA July 24, 2020 Vaccine Program Initiation January 27, 2020 Interim analysis finds evidence of efficacy SARS-CoV-2 Collaborations Phase 1 / 2a Trial FDA Fast Track Initiated Rolling Submissions November 9, 2020 Genetic Sequence Fosun Pharma: Germany Started April 23, 2020 designation • Up to 200 subjects EMA: October 6, 2020 Made Public March 16, 2020 July 13, 2020 Interim analysis finds more than aged 18 – 55 Canada: October 7, 2020 January 12, 2020 90% effective in preventing UK: October 9, 2020 Pfizer: U.S. Started May 4, 2020 COVID-19 in participants without March 17, 2020 • Up to 360 subjects evidence of prior SARS-CoV-2 aged 18 – 85 infection 6 BNT162b2 Phase 3 trial Up to 44,000 participants Primary Efficacy Objectives 21 days apart Efficacy against confirmed COVID-19 in participants without evidence of Healthy participants infection before vaccination Vaccinated group 18-85 (+16-17,12-15) yrs of age Placebo group Efficacy against confirmed COVID-19 in participants with and without 162b2 BNT evidence of infection before Active surveillance vaccination 43,538 participants enrolled for potential COVID-19 symptoms TRIGGERING telehealth or in- 38,955 received 2nd dose person visit and nasal swab Number of confirmed COVID-19 cases ≥ day 7 post dose 2 Overall Race/Ethnicity Study Asian 5% • Interim analysis of unblinded data by independent data monitoring committee on Nov 8, 2020 : Black 10% - 94 disease cases accrued, split of disease cases indicates >90% Vaccine Efficacy Hispanic/Latinx 26% - Benign safety profile Native American 0.8% • Final efficacy analysis at 164 disease cases expected end of November, 2020 Data as of November 08th, 2020 • Vaccinated participants will continue to be monitored for up to 2 years 7 Titelmasterformat durch Klicken bearbeiten BNT162: Global development program expanded to additional regions Phase 2/31 1 Phase 2/3 Phase 1/2 Phase 1 Phase 2/3 Phase 2/3 Regulatory submissions on a rolling basis Phase 2/3 Ongoing trials Phase 2/3 Regulatory submission on a rolling basis to EMA, MHRA (UK) and Health Canada initiated in October 8 1Phase 1/2 remains ongoing in U.S.