Moderna Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Provides Business Updates
Moderna reported fourth quarter 2022 revenues of $5.1 billion and full-year revenues of $19.3 billion. The company achieved a GAAP net income of $1.5 billion for Q4, with a corresponding diluted EPS of $3.61, marking a year-over-year decline. Among its notable developments, Moderna expects approximately $5 billion in contracted COVID-19 sales for 2023, alongside advancements in its mRNA-1345 RSV vaccine, which received FDA Breakthrough Therapy Designation. The company plans to elevate R&D investments to $4.5 billion in 2023 while announcing corporate leadership changes.
- Full-year 2022 revenues increased to $19.3 billion, up from $18.5 billion in 2021.
- Contracted COVID-19 sales for 2023 expected to be approximately $5 billion.
- mRNA-1345 received FDA Breakthrough Therapy Designation.
- R&D investment planned to increase to $4.5 billion in 2023.
- Q4 2022 revenue decreased by 29% compared to Q4 2021.
- Net income for Q4 dropped 70% year-over-year.
- Significant costs related to inventory write-downs and unutilized manufacturing capacity.
Fourth quarter 2022 revenues of
Full-year 2022 revenues of
Company reiterating approximately
Company will file for regulatory approval for mRNA-1345, Moderna's investigational RSV vaccine for older adults, in the first half of 2023. mRNA-1345 was recently granted FDA Breakthrough Therapy Designation
mRNA-1010 Phase 3 flu vaccine interim efficacy analysis expected to be reviewed by an independent DSMB before the end of the first quarter
mRNA-4157, Moderna's investigational personalized cancer vaccine in combination with Keytruda®, was granted Breakthrough Therapy Designation; full data set to be shared at upcoming medical oncology meeting and in peer reviewed publication
Company R&D investments planned to increase to
CAMBRIDGE, MA / ACCESSWIRE / February 23, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the fourth quarter and fiscal year 2022.
"2022 was another impressive year for Moderna, with over
Moderna is also announcing that Juan Andres, currently President, Strategic Partnerships and Enterprise Expansion, will be retiring from the Company in May after more than six years.
"Juan has played a tremendous role since joining Moderna in 2017. Juan served as Chief Technical Operations and Quality Officer and led our manufacturing from an early-stage clinical development company to a commercial company. In 2020 and 2021, Juan did a historic job with his team to scale Moderna for a global commercial launch, during a pandemic. It is unbelievable that he led the team from having made less than 100,000 doses across our entire portfolio in 2019 to more than 800 million doses in 2021 of our COVID-19 vaccine globally, all during a pandemic," said Mr. Bancel. "Very few manufacturing leaders could have led such an achievement during such a challenging time. We, and the hundreds of millions of people across the globe who received the Moderna COVID-19 vaccine, owe Juan our gratitude."
Recent Progress Includes:
Respiratory Vaccines
Approved and Phase 3 trials
- Spikevax Bivalent BA.4/BA.5 authorized under EUA in the U.S. as a booster dose for all age groups from 5 months.
- RSV vaccine in older adults (mRNA-1345) met its primary efficacy endpoint and received Breakthrough Therapy Designation from FDA. mRNA-1345 demonstrated vaccine efficacy of
83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms, and82.4% with 3 or more symptoms in older adults. mRNA-1345 was generally well-tolerated, with no safety concerns identified by the Data Safety Monitoring Board (DSMB). Based on these results, Moderna expects to submit a Biologics License Application (BLA) for mRNA-1345 to the FDA in the first half of 2023. The pediatric Phase 1 trial of mRNA-1345 is fully enrolled. - Flu (mRNA-1010) interim analysis from Phase 3 immunogenicity and safety trial demonstrated mRNA-1010 achieved superiority on seroconversion rates for A/H3N2 and A/H1N1, superiority on geometric mean titer ratios for A/H3N2, and non-inferiority on geometric mean titer ratios for A/H1N1. Non-inferiority was not met for seroconversion rates, and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains. mRNA-1010 was found to be generally well-tolerated.
- The ongoing mRNA-1010 Phase 3 efficacy study (P302) conducted in the Northern Hemisphere has accrued more than 200 PCR-confirmed cases. The first per-protocol interim analysis of efficacy is expected to be reviewed by an independent DSMB before the end of the first quarter.
Latent Vaccines
Phase 3 trials
- CMV vaccine (mRNA-1647) pivotal Phase 3 study, known as CMVictory, is ongoing, with enrollment more than
40% complete. CMV vaccine candidate mRNA-1647 adolescent trial dosed its first participants.
Early clinical
- First participants, adults 50 years of age or older, dosed in Phase 1/2 trial of varicella-zoster virus (VZV) candidate mRNA-1468. VZV causes chickenpox, commonly affecting children and young adults, and shingles in adults.
Therapeutics
Immuno-oncology
- Personalized cancer vaccine (PCV) Phase 2 evaluating mRNA-4157/V940 in combination with KEYTRUDA®, Merck's anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma reported positive topline data, showing a
44% reduction of recurrence or death versus Keytruda alone. - The companies have received Breakthrough Therapy Designation for mRNA-4157/V940.
- As previously announced on October 12, Merck exercised its option to jointly develop and commercialize mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement, and Moderna received
$250 million from Merck in the fourth quarter in connection with the option exercise. The companies plan to discuss results with regulatory authorities, initiate a Phase 3 study in adjuvant melanoma in 2023, and rapidly expand to additional tumor types, including non-small cell lung cancer (NSCLC).
Rare diseases
- The Phase 1/2 Paramount study of propionic acidemia (PA) candidate (mRNA-3927) is enrolling patients in cohort 5 (0.9mg/kg). Encouraging clinical benefit has been observed to date and all eligible participants continue to opt-in to the Open Label Expansion. Next step is dose selection for the expansion arm of the Phase 1/2 study.
- Moderna's partner, Vertex, initiated Phase 1 trial for VX-522, an mRNA therapy targeted at treating the underlying cause of cystic fibrosis (CF) lung disease for those who cannot benefit from a cystic fibrosis transmembrane conductance regulator (CFTR) modulator. VX-522 is Moderna's first inhaled mRNA to enter the clinic.
Cardiovascular disease
- Phase 1B trial of heart failure treatment candidate, mRNA-0184 was initiated. mRNA-0184 is designed to produce the naturally occurring cardioprotective hormone relaxin.
Moderna now has 48 programs 1 in development across 45 development candidates, of which 38 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 140 peer-reviewed publications.
Fourth Quarter and Full Year 2022 Financial Results
Revenue: Total revenue for the fourth quarter of 2022 was
Cost of Sales: Cost of sales was
Research and Development Expenses: Research and development expenses for the fourth quarter of 2022 increased by
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of 2022 increased by
Effective Tax Rate: The effective tax rate was
Net Income: Net income decreased by
Earnings Per Share: Diluted EPS decreased by
Full Year 2022
Revenue: Total revenue was
Cost of Sales: Cost of sales was
Research and Development Expenses: Research and development expenses increased by
Selling, General and Administrative Expenses: Selling, general and administrative expenses increased by
Provision for Income Taxes: The effective tax rate was
Net Income: Net income decreased by
Earnings Per Share: Diluted EPS decreased by
Cash Position: Cash, cash equivalents and investments as of December 31, 2022 and December 31, 2021 were
Net Cash Provided By Operating Activities: Net cash provided by operating activities was
Cash Used for Purchases of Property, Plant and Equipment: Cash used for purchases of property and equipment was
Cash Used for Repurchases of Common Stock: Cash used for repurchases of common stock was
2023 Financial Framework
Advance Purchase Agreements (APAs): The Company has COVID vaccine sales of approximately
Cost of Sales: Cost of sales for the full year are expected to be in the range of 35
Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses : Full-year expenses are expected to be approximately
Income Tax Provision: The Company expects a negligible provision for income taxes in 2023.
Capital Expenditures: The Company expects capital investments for 2023 of approximately
Share Repurchase Program
The
Corporate Updates
- Continued Growth: Moderna had approximately 3,900 employees as of December 31, 2022, compared to approximately 2,700 employees as of December 31, 2021.
- Company Accolades
- Moderna named a Top Employer by Science and Science Careers for an eighth consecutive year.
- Moderna named Top Employer by BioSpaces Best Places to Work for Second Consecutive Year.
- Executive Committee Update
- Juan Andres, President, Strategic Partnerships has announced that he will retire from the Company in May 2023.
- Moderna previously announced that Jerh Collins joined the Company in October as Chief Technical Operations and Quality Officer.
- On December 7, Brad Miller was appointed Chief Information Officer of Moderna. At the same time, Marcello Damiani, who was serving in the role as Chief Digital Officer, announced that he would retire from the Company after seven and a half years.
Key 2023 Investor and Analyst Event Dates
- Vaccines Day: April 11
- R&D Day: September 13
- ESG Day: December 7
Investor Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, February 23, 2023. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.
- Telephone: https://register.vevent.com/register/BI7d95b0c10db64ef48ce2960a272f006a
- Webcast: https://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 and integrated manufacturing facilities that allow 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 eight years. To learn more, visit www.modernatx.com
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(Unaudited, in millions, except per share data)
Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue: | ||||||||||||||||
Product sales | $ | 4,859 | $ | 6,935 | $ | 18,435 | $ | 17,675 | ||||||||
Other revenue 1 | 225 | 276 | 828 | 796 | ||||||||||||
Total revenue | 5,084 | 7,211 | 19,263 | 18,471 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of sales | 1,918 | 952 | 5,416 | 2,617 | ||||||||||||
Research and development | 1,211 | 648 | 3,295 | 1,991 | ||||||||||||
Selling, general and administrative | 375 | 201 | 1,132 | 567 | ||||||||||||
Total operating expenses | 3,504 | 1,801 | 9,843 | 5,175 | ||||||||||||
Income from operations | 1,580 | 5,410 | 9,420 | 13,296 | ||||||||||||
Interest income | 87 | 7 | 200 | 18 | ||||||||||||
Other expense, net | (12 | ) | (7 | ) | (45 | ) | (29 | ) | ||||||||
Income before income taxes | 1,655 | 5,410 | 9,575 | 13,285 | ||||||||||||
Provision for income taxes | 190 | 542 | 1,213 | 1,083 | ||||||||||||
Net income | $ | 1,465 | $ | 4,868 | $ | 8,362 | $ | 12,202 | ||||||||
Earnings per share: | ||||||||||||||||
Basic | $ | 3.81 | $ | 12.03 | $ | 21.26 | $ | 30.31 | ||||||||
Diluted | $ | 3.61 | $ | 11.29 | $ | 20.12 | $ | 28.29 | ||||||||
Weighted average common shares used in calculation of earnings per share: | ||||||||||||||||
Basic | 385 | 405 | 394 | 403 | ||||||||||||
Diluted | 405 | 431 | 416 | 431 |
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions, except per share data)
December 31, | December 31, | |||||||
2022 | 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 3,205 | $ | 6,848 | ||||
Investments | 6,697 | 3,879 | ||||||
Accounts receivable | 1,385 | 3,175 | ||||||
Inventory | 949 | 1,441 | ||||||
Prepaid expenses and other current assets | 1,195 | 728 | ||||||
Total current assets | 13,431 | 16,071 | ||||||
Investments, non-current | 8,318 | 6,843 | ||||||
Property, plant and equipment, net | 2,018 | 1,241 | ||||||
Right-of-use assets, operating leases | 121 | 142 | ||||||
Deferred tax assets | 982 | 326 | ||||||
Other non-current assets | 988 | 46 | ||||||
Total assets | $ | 25,858 | $ | 24,669 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 487 | $ | 302 | ||||
Accrued liabilities | 2,101 | 1,472 | ||||||
Deferred revenue | 2,038 | 6,253 | ||||||
Income taxes payable | 48 | 876 | ||||||
Other current liabilities | 249 | 225 | ||||||
Total current liabilities | 4,923 | 9,128 | ||||||
Deferred revenue, non-current | 673 | 615 | ||||||
Operating lease liabilities, non-current | 92 | 106 | ||||||
Financing lease liabilities, non-current | 912 | 599 | ||||||
Other non-current liabilities | 135 | 76 | ||||||
Total liabilities | 6,735 | 10,524 | ||||||
Stockholders' equity: | ||||||||
Additional paid-in capital | 1,173 | 4,211 | ||||||
Accumulated other comprehensive loss | (370 | ) | (24 | ) | ||||
Retained earnings | 18,320 | 9,958 | ||||||
Total stockholders' equity | 19,123 | 14,145 | ||||||
Total liabilities and stockholders' equity | $ | 25,858 | $ | 24,669 |
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)
Years Ended December 31, | ||||||||
2022 | 2021 | |||||||
Operating activities | ||||||||
Net income | $ | 8,362 | $ | 12,202 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||
Stock-based compensation | 226 | 142 | ||||||
Depreciation and amortization | 348 | 232 | ||||||
Amortization/accretion of investments | 31 | 54 | ||||||
Deferred income taxes | (559 | ) | (318 | ) | ||||
Other non-cash items | 28 | - | ||||||
Changes in assets and liabilities: | ||||||||
Accounts receivable | 1,790 | (1,784 | ) | |||||
Prepaid expenses and other assets | (1,699 | ) | (489 | ) | ||||
Inventory | 492 | (1,394 | ) | |||||
Right-of-use assets, operating leases | 21 | (58 | ) | |||||
Accounts payable | 240 | 204 | ||||||
Accrued liabilities | 612 | 989 | ||||||
Deferred revenue | (4,157 | ) | 2,824 | |||||
Income taxes payable | (828 | ) | 876 | |||||
Operating lease liabilities | (14 | ) | 17 | |||||
Other liabilities | 88 | 123 | ||||||
Net cash provided by operating activities | 4,981 | 13,620 | ||||||
Investing activities | ||||||||
Purchases of marketable securities | (11,435 | ) | (12,652 | ) | ||||
Proceeds from maturities of marketable securities | 3,151 | 1,338 | ||||||
Proceeds from sales of marketable securities | 3,548 | 3,105 | ||||||
Purchases of property, plant and equipment | (400 | ) | (284 | ) | ||||
Investment in convertible notes and equity securities | (40 | ) | (30 | ) | ||||
Net cash used in investing activities | (5,176 | ) | (8,523 | ) | ||||
Financing activities | ||||||||
Proceeds from issuance of common stock through equity plans | 65 | 124 | ||||||
Repurchase of common stock | (3,329 | ) | (857 | ) | ||||
Changes in financing lease liabilities | (184 | ) | (140 | ) | ||||
Net cash used in financing activities | (3,448 | ) | (873 | ) | ||||
Net (decrease) increase in cash, cash equivalents and restricted cash | (3,643 | ) | 4,224 | |||||
Cash, cash equivalents and restricted cash, beginning of year | 6,860 | 2,636 | ||||||
Cash, cash equivalents and restricted cash, end of period | $ | 3,217 | $ | 6,860 |
1 Includes grant revenue and collaboration revenue
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, including the timing of sales, under advance purchase agreements for delivery in 2023 and the associated dollar amounts to be received, which should not be construed as expected 2023 revenue; COVID market dynamics and potential additional sales in key markets; Moderna's plans to file for regulatory approval for mRNA-1345 (RSV for older adults) in the first half of 2023; timing for review of the mRNA-1010 (seasonal flu) Phase 3 interim efficacy analysis; the repurchase by Moderna of shares of its common stock under its repurchase programs; Moderna's collaboration with Merck to jointly develop and commercialize mRNA-4157/V940, plans to initiate a Phase 3 in adjuvant melanoma in 2023 and plans to expand into additional cancer types; timing for presentation of full data from the Phase 2 study of mRNA-4157/V940; plans for dose selection and study expansion for Moderna's propionic acidemia therapeutic; and Moderna's 2023 financial framework, including Moderna's anticipated spending on R&D in 2023. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each 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:
Chris Ridley
Vice President, Corporate Communications & Media
617-800-3651
Chris.Ridley@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.
SOURCE: Moderna, Inc.
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