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 $19 billion in revenue and significant clinical breakthroughs across our portfolio. We continue to provide our Omicron-targeting bivalent vaccines worldwide, with the latest real-world evidence highlighting the continued protection of our vaccines against hospitalization and death," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our infectious disease platform continues to progress with positive Phase 3 data in RSV for older adults. We are investing to scale Phase 3 manufacturing for personalized cancer vaccines so that we can run several Phase 3 studies simultaneously. With planned R&D investments of $4.5 billion for the year, I am excited about the new medicines we believe we will bring to patients in the coming few years."
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
Latent Vaccines
Phase 3 trials
Early clinical
Therapeutics
Immuno-oncology
Rare diseases
Cardiovascular disease
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 $5.1 billion, compared to $7.2 billion in the same period in 2021, mainly due to a decrease in sales of the Company's COVID-19 vaccines. Product sales for the fourth quarter of 2022 were $4.9 billion, a decrease of 30% compared to the same period in 2021, primarily driven by lower sales volume, compared to overall higher demand in the prior year and the related manufacturing ramp up in the fourth quarter of 2021.
Cost of Sales: Cost of sales was $1.9 billion, or 39% of product sales, for the fourth quarter of 2022, including third-party royalties of $604 million, of which $400 million related to a catch-up payment to the National Institute of Allergy and Infectious Diseases (NIAID) for a new royalty-bearing license agreement executed in December. The agreement provides for low single-digit royalties on future COVID-19 vaccine sales. Cost of sales, as a percentage of product sales, increased by 25 percentage points, from 14% in the same period in 2021. The increase was driven by increased royalties, a charge of $297 million for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, a loss on firm purchase commitments and related cancellation charges of $281 million, and an expense for unutilized manufacturing capacity and related contract manufacturing organization charges of $376 million. These charges, other than royalties, are driven by costs associated with surplus production capacity, overall lower demand and a shift to our most recent Omicron-targeting COVID-19 bivalent booster, mRNA-1273.222
Research and Development Expenses: Research and development expenses for the fourth quarter of 2022 increased by 87% to $1.2 billion, in comparison to the same quarter of 2021. The growth in spending was mainly due to an increase in clinical trial-related expenses, largely driven by increased clinical development activities, particularly with respect to our RSV, seasonal flu and CMV programs. The growth was also driven by the acquisition of a Priority Review Voucher and an increase in personnel-related costs due to increased headcount to support our increased research and development efforts.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of 2022 increased by 87% to $375 million, in comparison to the same quarter of 2021. The growth in spending was primarily due to increased external and marketing spend, driven by commercial activities in support of the Company's marketed products and build-out.
Effective Tax Rate: The effective tax rate was 11% for the fourth quarter of 2022, remained relatively flat, compared to 10% for the same period in 2021.
Net Income: Net income decreased by 70% to $1.5 billion in the fourth quarter of 2022, compared to the same period in 2021.
Earnings Per Share: Diluted EPS decreased by 68% to $3.61 in the fourth quarter of 2022, compared to the same period in 2021.
Full Year 2022
Revenue: Total revenue was $19.3 billion for the full year 2022, compared to $18.5 billion in 2021. Total revenue increased in 2022, primarily due to increased sales of the Company's COVID-19 vaccines. Product sales for 2022 were $18.4 billion, an increase of 4%, compared to 2021, primarily driven by a higher average selling price due to customer mix.
Cost of Sales: Cost of sales was $5.4 billion, or 29% of the product sales for 2022, including third-party royalties of $1.1 billion. Cost of sales, as a percentage of product sales, increased by 14 percentage points, from 15% in 2021. The increase was mainly due to a charge of $1.3 billion for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, a loss on firm purchase commitments and related cancellation charges of $725 million, and an expense for unutilized manufacturing capacity and related contract manufacturing organization charges of $776 million. These charges are driven by overall lower demand, in particular from low-income countries, a shift in product demand to our Omicron-targeting COVID-19 bivalent boosters and costs associated with surplus production capacity.
Research and Development Expenses: Research and development expenses increased by 65% to $3.3 billion for 2022, compared to 2021. The growth in spending in 2022 was mainly due to increases in clinical trial expenses, clinical manufacturing expenses, personnel-related costs, and consulting and outside services, largely driven by the Company's late-stage clinical studies for the RSV, seasonal flu and CMV vaccine programs, as well as continued development of the Company's pipeline.
Selling, General and Administrative Expenses: Selling, general and administrative expenses increased by 100% to $1.1 billion for 2022, compared to 2021. The growth in spending in 2022 was mainly due to increases in consulting and outside services, marketing expense, and personnel-related costs, primarily attributable to the Company's continued corporate expansion, particularly in the commercial area and to a lesser extent, in support functions.
Provision for Income Taxes: The effective tax rate was 13% for 2022, compared to 8% for 2021. The increase in 2022 was primarily due to the benefit recorded in 2021 related to the release of the valuation allowance on the majority of our deferred tax assets.
Net Income: Net income decreased by 31% to $8.4 billion for the full year 2022, compared to 2021.
Earnings Per Share: Diluted EPS decreased by 29% to $20.12 for the full year 2022, compared to 2021.
Cash Position: Cash, cash equivalents and investments as of December 31, 2022 and December 31, 2021 were $18.2 billion and $17.6 billion, respectively.
Net Cash Provided By Operating Activities: Net cash provided by operating activities was $5.0 billion for the full year 2022, compared to $13.6 billion for the same period in 2021. Net cash provided by operating activities decreased in 2022, primarily attributable to revenue recognized from deferred revenue in excess of customer deposits received and increased income tax payments, partially offset by higher collection of receivables.
Cash Used for Purchases of Property, Plant and Equipment: Cash used for purchases of property and equipment was $400 million for the full year 2022, compared to $284 million for the same period in 2021. The increase was primarily driven by the Company's continued business expansion of its manufacturing and research facilities.
Cash Used for Repurchases of Common Stock: Cash used for repurchases of common stock was $3.3 billion for the full year 2022. Moderna did not conduct share repurchases prior to the fourth quarter of 2021. From the end of the third quarter of 2021 to the end of the fourth quarter of 2022, the Company repurchased 27 million shares, reducing the number of common shares outstanding from 405 million to 385 million, more than offsetting 7 million shares of common stock issued in connection with equity compensation over this period.
2023 Financial Framework
Advance Purchase Agreements (APAs): The Company has COVID vaccine sales of approximately $5 billion currently contracted for 2023 delivery, with potential additional sales opportunities in the United States (endemic private and government markets), Europe, Japan, and other key markets. The Company expects product sales in the first half of 2023 of approximately $2.0 billion.
Cost of Sales: Cost of sales for the full year are expected to be in the range of 35-40% of sales, which includes approximately 5% of sales for combined royalties to Cellscript and NIAID.
Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses : Full-year expenses are expected to be approximately $6.0 billion, with approximately $4.5 billion in R&D.
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 $1.0 billion.
Share Repurchase Program
The $3 billion share repurchase program announced in February 2022 was completed early in the fourth quarter 2022. The Company has commenced repurchases from the additional $3 billion program announced in August 2022, and currently has $2.8 billion remaining under this latest authorization.
Corporate Updates
Key 2023 Investor and Analyst Event Dates
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.
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
This email address is being protected from spambots. You need JavaScript enabled to view it.
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
This email address is being protected from spambots. You need JavaScript enabled to view it.
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.
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