Moderna Reports First Quarter 2022 Financial Results and Provides Business Updates – Moderna Investor Relations

First quarter 2022 revenues of $6.1 billion; GAAP net-income of $3.7 billion and GAAP diluted EPS of $8.58
Moderna reiterates its 2022 signed advance purchase agreements of approximately $21 billion
Company expects to have four programs in Phase 3 in the second quarter: Omicron-containing bivalent COVID booster, flu, RSV, CMV
CAMBRIDGE, MA / ACCESSWIRE / May 4, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the first quarter of fiscal year 2022.
“The Moderna team delivered a strong Q1 performance and I am thankful for the progress our team continues to make as we advance our pipeline of mRNA medicines. Today, we are reiterating our signed advanced purchase agreements for 2022 of $21 billion. In the second quarter, we expect to have four programs in late-stage Phase 3 studies including our Omicron-containing bivalent COVID booster, seasonal flu, RSV and CMV vaccine candidates.Beginning in the fall of 2022, our robust Phase 3 pipeline could lead to three respiratory commercial launches over the next two to three years. We also look forward to advancing our therapeutic programs and sharing proof-of-concept readouts on our rare genetic disease programs for propionic acidemia and methylmalonic acidemia, and on our personalized cancer vaccine program this year,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I would like to thank the global Moderna team for their commitment to our mission. mRNA has changed the future of medicine and I look forward to continuing our impact on human health. This is just the beginning.”
Recent progress includes:
Respiratory Vaccines
Latent Vaccines
Public Health Vaccines
Therapeutics
Moderna now has 46 programs in development across 43 development candidates1, of which 29 are currently in active clinical trials. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 115 peer reviewed manuscripts.
First Quarter 2022 Financial Results
2022 Financial Framework
Management Updates
Corporate Updates
Key 2022 Investor and Analyst Event Dates
Summary of Program Highlights by Modality2
Core Modalities
Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is an unmet medical need, including vaccines against respiratory infections and vaccines against latent viruses.
Vaccines against acute respiratory infections
Vaccines against latent viruses
Public health vaccines
Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.
Cancer Vaccines: These programs focus on stimulating a patient’s immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.
Intratumoral Immuno-Oncology : These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.
Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.
Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.
Inhaled Pulmonary Therapeutics
Information about each development candidate in Moderna’s pipeline can be found at investors.modernatx.com.
Investor Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, May 4, 2022. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 2083116. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: anticipated sales under advanced purchase agreements in 2022 and the associated dollar amounts to be received, which should not be construed as expected 2022 revenue; Moderna’s ongoing discussions with countries regarding additional advanced purchase agreements; COVID market dynamics and anticipated timing of sales in 2022; the number of programs Moderna expects to have in Phase 3 studies in the second quarter of 2022; timing of new data on Moderna’s therapeutics development candidates in rare genetic diseases and oncology; timing of initial data on mRNA-1273.214; timing of submissions to regulators and review periods with respect to Moderna’s COVID-19 vaccine; the ability of mRNA-1283 to elicit a robust anti-SARS-CoV-2 neutralizing antibody response; Moderna’s 2022 financial framework; Moderna’s appointments of executive officers; Moderna’s plans to construct mRNA manufacturing facilities in Kenya, Canada and Australia; Moderna’s mRNA Access initiative to allow researchers access to Moderna’s mRNA platform; the potential for superiority of mRNA-1010 to standard dose vaccine for influenza A strains and non-inferiority to standard dose vaccine in influenza B strains; the potential for the Company’s seasonal flu vaccine candidates to provide broader coverage of protection and to improve immunity against seasonal flu; expected enrollment in Moderna’s pivotal Phase 3 study of RSV in older adults; Moderna’s plans to pursue longer-term potential indications for mRNA-1195; Moderna’s expectations regarding the administration of mRNA-0184; and timing of the Phase 2 data readout for mRNA-4157. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
Colleen Hussey
Senior Director, Corporate Communications
617-335-1374
Colleen.Hussey@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
1 Includes separate COVID Vaccine (mRNA-1273) programs in development for adults, pediatrics & adolescents and separate RSV vaccine (mRNA-1345) programs in development for adults and pediatrics
2 Unless otherwise specified, Moderna owns commercial worldwide rights to each of the programs described here.
3 BARDA, part of ASPR within the U.S. HHS is supporting the continued research and development of the Company’s COVID vaccine development efforts with federal funding under contract no. 75A50120C00034 BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.
4 Saade A et al, Infect Dis Now (2021), https://doi.org/10.1016/j.idnow.2021.07.005
5 Jacobs M et al, Mult Scler. (2020), https://doi.org/10.1177/1352458520907901
SOURCE: Moderna, Inc.
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