BioNTech SE · NASDAQ:BNTX
BioNTech — Q2 2022 Earnings Presentation
32 slides from BioNTech's earnings presentation, Aug 8, 2022
Slide 1: 2nd Quarter 2022 Financial Results & Corporate Update
2nd Quarter 2022 Financial Results & Corporate Update August 8, 2022 Exhibit 99.2
Slide 2: Forward-looking statements
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: our expected revenues and net profit related to sales of our COVID-19 vaccine, referred to as COMIRNATY®
Slide 3: COMIRNATY EU authorization and important safety information
COMIRNATY® ▼(the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorization (CMA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 5 yrs of age. The vaccine is administered as a 2-dose series, 3 weeks apart. In addition, the CMA has
Slide 4: Safety Information: Authorized use in the U.S.
Safety Information AUTHORIZED USE IN THE U.S. • COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 yrs of age and older
Slide 5: Safety information: myocarditis and side effects
• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 yrs of age than among females and older males. In most of these people, symptoms began within a
Slide 6: Agenda
Corporate Outlook Ryan Richardson, Chief Strategy Officer Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO 2nd Quarter 2022 Highlights Ugur Sahin, CEO 6
Slide 7: Advancing Toward Our Vision
Advancing Toward Our Vision Oncology Infectious diseases 5 randomized Phase 2 trials 1 marketed vaccine Market leader in COVID-19 vaccines 10+ preclinical programs, 4 FIH trials to start 1 Phase 1 program18 programs in 23 clinical trials Maintain and deepen COVID-19 vaccine leadership Multiple produ
Slide 8: Highlights in Q2: Corporate & Oncology Pipeline
Highlights in Q2: Corporate & Oncology Pipeline • Reported Q2 total revenues of €3.2 bn1 and year-to-date revenues of €9.6 bn1 • Began construction of first BioNTainer mRNA vaccine manufacturing facility in Africa • Signed new equal share cost/profit collaboration agreement with Genmab for joint dev
Slide 9: Highlights in Q2: COVID-19 Vaccine / COMIRNATY
Highlights in Q2: COVID-19 Vaccine / COMIRNATY • FDA granted EUA for primary series in children 6 months through 4 yrs of age and for booster dose in children 5 through 11 yrs of age Pediatric label now includes1: • 6 mo. to <5 yrs (3 µg) • 5 yrs to <12 yrs (10 µg) • 12 yrs+ (30 µg) • More than 3.6
Slide 10: SARS-CoV-2 Epidemiology Changes Quickly: Vaccine Updates Need Timely Adaptation
SARS-CoV-2 Epidemiology Changes Quickly: Vaccine Updates Need Timely Adaptation With the Pace of Virus CMC, chemistry, manufacturing and controls GISAID Initiative database: https://www.gisaid.org/ (accessed June 20, 2022). ~8 months ~3 months Clinical (current) Pre-clinical/CMC (proposed) Variant v
Slide 11: Regulators recommended Omicron-adapted bivalent vaccines
FDA, EMA and other regulators recommended Omicron-adapted bivalent vaccines Submissions ongoing worldwide for both BA.1- and BA.4/5-adapted bivalent vaccines • FDA: Provided guidance for bivalent vaccine encoding Omicron BA.4/5 spike protein • EMA: Omicron BA.1-adapted bivalent vaccine submission fi
Slide 12: Agenda
Corporate Outlook Ryan Richardson, Chief Strategy Officer04 03 Financial Results Jens Holstein, CFO Pipeline Update Özlem Türeci, CMO 01 2nd Quarter 2022 Highlights Ugur Sahin, CEO 12
Slide 13: Omicron BA.1 Adapted Vaccines as 4th Dose Elicit Improved Neutralization
F F R N T 5 0 501.1 822.0 771.3 678.1 78.4 145.3 226.3 137.2 10 100 1,000 10,000 OMI 30 μg… OMI 60 μg… Bivalent 30 μg… Bivalent 60 μg… BA.1 BA.4/5 LOD Omicron-BA.1 Adapted Vaccines as 4th Dose Elicit Improved Omicron Neutralization Response Internal data. FFRNT, fluorescent foci reduction neutraliza
Slide 14: Omicron BA.4/5 RBD and NTD Sequences Distinct From BA.1 and BA.2
NTD RBDNTD RBD Omicron BA.4/5 RBD and NTD Sequences are distinct From BA.1 and BA.2 14 RBD, receptor binding domain; NTD, N-terminal domain Stalls et al., Cryo-EM structures of SARS-CoV-2 Omicron BA.2 spike. Cell reports, 2022
Slide 15: Omicron BA.4/5 Boosters in Mice Increase Neutralization Responses
Omicron BA.4/5 Monovalent and Bivalent Boosters in Mice Substantially Increase Omicron Neutralization Responses to All Tested Omicron Variants Compared to Monovalent OMI BA.1, BA.4/5 neutralizing titers increase by ~11.3 fold (mono BA.4/5) or ~4.8 fold (bivalent BA.4/5) OMI BA.1 OMI BA.4/5 BNT162b2
Slide 16: Pursuing Multiple Novel COVID-19 Vaccine Approaches
Pursuing Multiple Novel COVID-19 Vaccine Approaches to Provide Durable and High-Level Protection against Evolving Variants T cell enhancing vaccine candidate Designed to stimulate and enhance T cell immunity Pan-SARS-CoV-2 vaccine candidate Potential for greater, more durable protection to manage fu
Slide 17: Oncology Pipeline: Significant Progress and Expansion in 2022
SMIM, small molecule immunomodulators. 1 Investigator-initiated Phase 1 trial; 2 Collaboration with Genentech; 3 Collaboration with Sanofi; 4 Collaboration with Genmab. Oncology Pipeline: Significant Progress and Expansion in 2022 Drug class Platform Product candidate Indication (targets) Pre-clinic
Slide 18: FixVac BNT116: Phase 1 Trial in Advanced NSCLC
FixVac ǀ BNT116: Phase 1 Trial in Patients with Advanced NSCLC NSCLC, non-small-cell lung cancer; TPS, tumor proportion score *Regeneron’s Libtayo® Clinicaltrials.gov: NCT05142189. Advanced or metastatic non-small-cell lung cancer FPD in July 2022Primary: Safety and tolerability Secondary: Clinical
Slide 19: RiboMabs: Nucleoside-modified mRNA Encoding Antibody Formats
Titelmasterformat durch Klicken bearbeitenRiboMabs: Nucleoside-modified mRNA Encoding Variable Antibody Formats for in vivo Translation In vivo translation and systemic availability of active drug at therapeutically relevant plasma concentrations • mRNA backbone designed for minimal immunogenicity •
Slide 20: iNeST Autogene Cevumeran (BNT122) for Adjuvant Pancreatic Cancer
iNeST ǀ Autogene Cevumeran (BNT122) Phase 1 for Adjuvant Treatment of Pancreatic Cancer iNeST is being developed in collaboration with Genentech. RFS, recurrence-free survival Balachandran VP, et al. ASCO Annual Meeting 2022; Poster presentation 2516. Investor-initiated single-center study sponsored
Slide 21: Expanding Strategic Collaboration With Genmab
Expanding Strategic Collaboration With Genmab 1 Collaboration with Genmab based on 50/50 sharing of costs and profits 2 HexaBody® technology owned by Genmab Next-generation immunomodulators designed to prime and activate anti-tumor T cell and Natural Killer cell function Phase 1/2: Advanced solid tu
Slide 22: Agenda
Corporate Outlook Ryan Richardson, Chief Strategy Officer04 Financial Results Jens Holstein, CFO 02 Pipeline Update Özlem Türeci, CMO 01 2nd Quarter 2022 Highlights Ugur Sahin, CEO 22
Slide 23: Key Highlights for Q2 2022
€3.2 bn €2.2 bn €9.3 bn + €10.4 bn 1 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2021 as well as the Quarterly Report as of and for the three and six months en
Slide 24: Q2 and H1 2022 COVID-19 Vaccine Revenues
Q2 and H1 2022 COVID-19 Vaccine Revenues 1 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2021 as well as the Quarterly Report as of and for the three and six mon
Slide 25: Q2 and H1 2022 Financial Results – Profit or Loss
Q2 and H1 2022 Financial Results – Profit or Loss (in millions, except per share data)1 Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Commercial revenues2 €3,166.3 €5,280.5 €9,528.5 €7,308.0 Research & development revenues 30.2 28.0 42.6 48.9 Total revenues €3,196.5 €5,30
Slide 26: 2022 Financial Year Guidance Reiterated
2022 Financial Year Guidance Reiterated 1 Ranges reflect current base case projections and do not include potential effects caused by or driven from additional collaborations or potential M&A transactions. 2 BioNTech Group estimated annual effective income tax rate decreased from 31.6% (FY 2021) to
Slide 27: Agenda
Corporate Outlook Ryan Richardson, Chief Strategy Officer 03 Financial Results Jens Holstein, CFO 02 Pipeline Update Özlem Türeci, CMO 01 2nd Quarter 2022 Highlights Ugur Sahin, CEO 27
Slide 28: Strong Position and Outlook for Global COVID-19 Vaccine Franchise
Strong Position and Outlook for Global COVID-19 Vaccine Franchise 1 As of beginning of July 2022 2 Cumulative Share of Doses from January 1, 2022 to July 20, 2022 in markets in which Pfizer and BioNTech operate and that report market share data 3 Incl. all markets in Developed Markets(4) plus Emergi
Slide 29: Delivering on Commitment to Provide Equitable Access to Medicines
Delivering on Commitment to Provide Equitable Access to Medicines • End-to-end mRNA production units with capacity of up to >50 million doses/year • First manufacturing facility to become a node in decentralized and robust African end-to-end manufacturing network • Construction of facility underway
Slide 30: Selected 2022 Pipeline Milestones
Titelmasterformat durch Klicken bearbeiten Selected 2022 Pipeline Milestones Milestones Anticipated Timing COVID-19 vaccine: Follow on and Next Gen Vaccines Omicron BA.4/5-adapted bivalent vaccine trial start August 2022 BNT162b5: Next-generation bivalent vaccine, enhanced SARS-CoV-2 encoding ancest
Slide 31: Outlook 2022 and Beyond
Outlook 2022 and Beyond Further development of COVID-19 vaccine Accelerate late- stage oncology programs Advance infectious disease portfolio Pursue complementary acquisitions Transform & expand global organization Once in a generation opportunity to transform medicine Bring long-term value to patie
Slide 32: Thank You
THANK YOU BIONT=Crf