Moderna Reports Third Quarter 2023 Financial Results and Provides Business Updates
- Moderna expects 2023 revenues of at least $6 billion, driven by Spikevax sales and strong market share.
- The company anticipates revenue of approximately $4 billion in 2024, with a return to growth in 2025.
- Moderna has improved its future cost of sales by resizing its manufacturing capacity.
- The late-stage pipeline includes six Phase 3 programs, indicating potential future growth.
- The company expects to break even in 2026 through product launches and disciplined investment.
- The company reported a net loss of $3.6 billion in Q3 2023, primarily due to non-cash charges related to resizing and tax valuation allowance.
- Third quarter 2023 revenues of
$1.8 billion ; Company expects 2023 revenues of at least$6 billion - Spikevax U.S. market share to date increased to
45% from36% in 2022 - Company anticipates 2024 revenue of approximately
$4 billion and return to growth in 2025 - Company has significantly improved future cost of sales by resizing its manufacturing capacity, contributing to a third quarter net loss of
$3.6 billion , primarily driven by mostly non-cash charges of$3.1 billion related to resizing and a tax valuation allowance - Company's late-stage pipeline has six Phase 3 programs
- Company expects to break even in 2026 through product launches and disciplined investment
CAMBRIDGE, MA / ACCESSWIRE / November 2, 2023 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the third quarter of 2023.
"Through this quarter, we demonstrated our ability to increase share in the U.S. market, and we now expect this year's vaccination rate to be similar to last fall," said Stéphane Bancel, Chief Executive Officer of Moderna. "In the third quarter, we significantly resized our manufacturing infrastructure to make our COVID-19 franchise profitable for 2024 and beyond. We are preparing to launch multiple products through 2025, including our RSV vaccine. We expect to return to sales growth in 2025 and, through disciplined investment, to break even in 2026."
Recent progress includes:
2023 Commercial Updates
COVID-19: The Company reported
The Company continues to focus on public health efforts to increase vaccination rates globally. In the United States, the Company has undertaken significant marketing and awareness campaigns, working closely with vaccinators and others to drive a robust vaccination season, including by activating the medical community, supporting and re-engaging customers (including those who deferred updated vaccination due to recent infections) and amplifying the voices of credible influencers.
RSV: The Company continues to expect the launch of its RSV vaccine in 2024 with a potential best-in-class profile. Moderna has submitted marketing authorization applications globally for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older. The Company filed for a Biologics License Application (BLA) with the FDA and used a Priority Review Voucher (PRV) to accelerate review.
The regulatory applications are based on positive data from the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults, 60 years or older. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of
Moderna is preparing for the marketing launch of mRNA-1345 and believes its U.S. COVID-19 market share to date demonstrates the Company's ability to compete in the commercial market. The Company is encouraged by early indications of strong consumer awareness and demand in the RSV market. Moderna believes that clinical data for its RSV vaccine supports a best-in-class profile and that its ready-to-use pre-filled syringes (PFS) offer another competitive differentiator over currently licensed products, which require multiple preparatory steps by pharmacists and clinicians. Feedback from clinicians and customers in the COVID-19 market, where Moderna has a similar presentation, validates the benefits of PFS administration. The Company's pre-launch activities at this time are largely focused on scientific exchanges and public health engagements.
Third Quarter 2023 Financial Results
Revenue: Total revenue for the third quarter of 2023 was
Cost of Sales: Cost of sales for the third quarter of 2023 was
Research and Development Expenses: Research and development expenses for the third quarter of 2023 increased by
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of 2023 increased by
Income Taxes: Income taxes for the third quarter of 2023 were
Net Income (Loss): Net loss was
Earnings (Loss) Per Share: Diluted loss per share was
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments were
2023 Financial Framework
Product Sales: The Company now expects product sales of at least
Cost of Sales: The Company now expects cost of sales to be approximately
Respiratory Cost of Sales Framework: The Company's manufacturing resizing is expected to drive more predictable cost of sales going forward. Write-downs/charges are expected to be less than
Research and Development (R&D) and Selling, General and Administrative (SG&A): The Company now expects full-year 2023 expenses of approximately
Income Taxes: The Company now anticipates a full-year tax expense of approximately
Capital Expenditures: The Company expects capital expenditures for 2023 of approximately
Moderna Operating Principles
The Company expects its COVID-19 franchise to be profitable in its anticipated sales scenarios for 2024 and beyond. While Moderna plans to continue to invest in its business to drive an unparalleled opportunity for organic sales growth, the Company will be disciplined and will adjust its investments in R&D and SG&A based on its sales performance. Moderna expects to break even in 2026 through product launches and disciplined investments. The Company's current balance sheet is sufficient to fund its planned investments without raising additional equity.
Early Thoughts on 2024 and 2025 Sales
Moderna is projecting approximately
Clinical Updates
Moderna's mRNA platform is positioned to continue to deliver significant impact with our mRNA medicines. The Company is anticipating up to 15 launches in the next five years and provided a comprehensive overview of its pipeline and clinical programs at R&D Day in September. Moderna currently has therapeutics in development across four therapeutic areas, with a total of 43 development programs. Other notable updates are provided below.
Respiratory : Moderna has advanced three respiratory disease programs to positive Phase 3 data (COVID-19, RSV, Influenza).
Moderna also recently announced positive interim results from the Phase 1/2 trial of mRNA-1083, an investigational combination vaccine against seasonal influenza and COVID-19. Moderna's investigational combination vaccines are designed to deliver value to individuals, providers and healthcare systems through higher compliance, easier administration and greater convenience.
The ongoing Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT05827926) is a randomized, observer blind study evaluating the safety and immunogenicity of mRNA-1083 compared to a standard dose influenza vaccine, Fluarix, in adults 50-64 years of age and against an enhanced influenza vaccine, Fluzone HD, in adults 65-79 years of age. For both age groups, mRNA-1083 was compared against Spikevax booster.
The Company also recently announced that it has initiated a Phase 3 trial of mRNA-1083 in 2023 and is targeting initial regulatory approval for the combination vaccine in 2025. The Phase 3 study will evaluate the immunogenicity, safety, and reactogenicity of mRNA‐1083 as compared with active control, co‐administered licensed influenza and SAR‐CoV‐2 vaccines in 8,000 healthy adults 50 years of age or older.
mRNA‐1083 has the potential to efficiently reduce the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza and SARS‐CoV‐2 viruses in a single injection. mRNA‐1083 offers greater convenience and has the potential to lead to increased compliance with vaccine recommendations. This approach could benefit public health by synergistically increasing coverage rates against influenza and SARS‐CoV‐2 viruses.
Latent: The pivotal Phase 3 study of Moderna's CMV vaccine candidate (mRNA-1647), known as CMVictory, is fully enrolled including an adolescent cohort. The trial evaluates the efficacy, safety and immunogenicity of mRNA-1647 in the prevention of primary infection in women of childbearing age.
INT: In April 2023, Moderna and Merck reported the results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV). In the overall intention-to-treat population, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) and reduced the risk of recurrence or death by
Merck and Moderna announced the initiation of a pivotal Phase 3 study (V940-001) to evaluate the safety and efficacy of mRNA-4157 (V940) in combination with KEYTRUDA in people with resected high-risk (Stage IIB-IV) melanoma compared to KEYTRUDA alone. The primary endpoint of the study is recurrence-free survival, and secondary endpoints include distant metastasis-free survival, overall survival and safety. That trial is underway globally.
The Companies will also imminently commence a Phase 3 trial in non-small cell lung cancer (NSCLC) in patients with resected stage II-IIIB NSCLC who have received adjuvant chemotherapy, with no recurrence. The primary endpoint is disease free survival compared to pembrolizumab. Secondary endpoints are overall survival, distant metastasis-free survival, and safety. The trial is expected to enroll approximately 868 patients.
Moderna and Merck plan to expand the INT development program to additional tumor types.
Moderna is scaling manufacturing to support clinical development and commercial markets. The Company is also currently building a manufacturing site in Marlborough, MA as a commercial INT manufacturing facility.
Corporate Updates
- Moderna announced strategic partnerships with Immatics and CARsgen
- Moderna announced positive clinical results across cancer, rare disease and infectious disease at its 8th annual R&D Day
Company Accolades:
- Moderna was ranked as one of the top employers in the global biopharmaceutical industry by Science and Science Careers' 2023 Top Employers Survey (ninth consecutive year on the list)
- Moderna was named to the Boston Business Journal's annual list of the Most Charitable Companies in Massachusetts (first year on the list)
- Moderna was recognized as a top-scoring company on the Disability: IN's Disability Equality Index (second consecutive year on the list)
Key 2023 Investor and Analyst Event Dates
- Digital Day: November 8
- 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 November 2, 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/BI9ee4891809624391a5618bb9e2ca440f
- 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-19 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 nine years. To learn more, visit www.modernatx.com.
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in millions, except per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Revenue: | |||||||||||
Net product sales | $ | 1,757 | $ | 3,120 | $ | 3,878 | $ | 13,576 | |||
Other revenue1 | 74 | 244 | 159 | 603 | |||||||
Total revenue | 1,831 | 3,364 | 4,037 | 14,179 | |||||||
Operating expenses: | |||||||||||
Cost of sales | 2,241 | 1,100 | 3,764 | 3,498 | |||||||
Research and development | 1,160 | 820 | 3,439 | 2,084 | |||||||
Selling, general and administrative | 442 | 278 | 1,079 | 757 | |||||||
Total operating expenses | 3,843 | 2,198 | 8,282 | 6,339 | |||||||
(Loss) income from operations | (2,012) | 1,166 | (4,245) | 7,840 | |||||||
Interest income | 105 | 58 | 318 | 113 | |||||||
Other expense, net | (51) | (7) | (85) | (33) | |||||||
(Loss) income before income taxes | (1,958) | 1,217 | (4,012v | 7,920 | |||||||
Provision for income taxes | 1,672 | 174 | 919 | 1,023 | |||||||
Net (loss) income | $ | (3,630) | $ | 1,043 | $ | (4,931) | $ | 6,897 | |||
(Loss) earnings per share: | |||||||||||
Basic | $ | (9.53) | $ | 2.67 | $ | (12.89) | $ | 17.41 | |||
Diluted | $ | (9.53) | $ | 2.53 | $ | (12.89) | $ | 16.46 | |||
Weighted average common shares used in calculation of (loss) earnings per share: | |||||||||||
Basic | 381 | 390 | 382 | 396 | |||||||
Diluted | 381 | 412 | 382 | 419 |
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1 Includes grant revenue and collaboration revenue
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions)
September 30, | December 31, | ||||
2023 | 2022 | ||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 2,932 | $ | 3,205 | |
Investments | 4,641 | 6,697 | |||
Accounts receivable, net | 1,866 | 1,385 | |||
Inventory | 487 | 949 | |||
Prepaid expenses and other current assets | 873 | 1,195 | |||
Total current assets | 10,799 | 13,431 | |||
Investments, non-current | 5,273 | 8,318 | |||
Property, plant and equipment, net | 1,952 | 2,018 | |||
Right-of-use assets, operating leases | 765 | 121 | |||
Deferred tax assets | - | 982 | |||
Other non-current assets | 661 | 988 | |||
Total assets | $ | 19,450 | $ | 25,858 | |
Liabilities and Stockholders' Equity | |||||
Current liabilities: | |||||
Accounts payable | $ | 494 | $ | 487 | |
Accrued liabilities | 2,224 | 2,101 | |||
Deferred revenue | 1,372 | 2,038 | |||
Income taxes payable | 56 | 48 | |||
Other current liabilities | 239 | 249 | |||
Total current liabilities | 4,385 | 4,923 | |||
Deferred revenue, non-current | 166 | 673 | |||
Operating lease liabilities, non-current | 697 | 92 | |||
Financing lease liabilities, non-current | 575 | 912 | |||
Other non-current liabilities | 172 | 135 | |||
Total liabilities | 5,995 | 6,735 | |||
Stockholders' equity: | |||||
Additional paid-in capital | 277 | 1,173 | |||
Accumulated other comprehensive loss | (211) | (370) | |||
Retained earnings | 13,389 | 18,320 | |||
Total stockholders' equity | 13,455 | 19,123 | |||
Total liabilities and stockholders' equity | $ | 19,450 | $ | 25,858 |
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)
Nine Months Ended September 30, | |||||
2023 | 2022 | ||||
Operating activities | |||||
Net (loss) income | $ | (4,931) | $ | 6,897 | |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | |||||
Stock-based compensation | 226 | 164 | |||
Depreciation and amortization | 419 | 268 | |||
Amortization/accretion of investments | (41) | 35 | |||
Loss on equity investments, net | 16 | - | |||
Deferred income taxes | 934 | (473) | |||
Other non-cash items | 25 | 36 | |||
Changes in assets and liabilities, net of acquisition of business: | |||||
Accounts receivable, net | (481) | 480 | |||
Prepaid expenses and other assets | 772 | (669) | |||
Inventory | 462 | (636) | |||
Right-of-use assets, operating leases | (657) | 29 | |||
Accounts payable | (8) | 89 | |||
Accrued liabilities | 63 | 354 | |||
Deferred revenue | (1,173) | (2,691) | |||
Income taxes payable | 8 | (810) | |||
Operating lease liabilities | 605 | (27) | |||
Other liabilities | 21 | 273 | |||
Net cash (used in) provided by operating activities | (3,740) | 3,319 | |||
Investing activities | |||||
Purchases of marketable securities | (2,097) | (8,925) | |||
Proceeds from maturities of marketable securities | 4,711 | 2,222 | |||
Proceeds from sales of marketable securities | 2,725 | 2,918 | |||
Purchases of property, plant and equipment | (487) | (308) | |||
Acquisition of business, net of cash acquired | (85) | - | |||
Investment in convertible notes and equity securities | (23) | (35) | |||
Net cash provided by (used in) investing activities | 4,744 | (4,128) | |||
Financing activities | |||||
Proceeds from issuance of common stock through equity plans | 31 | 40 | |||
Repurchase of common stock, including excise tax | (1,153) | (2,927) | |||
Changes in financing lease liabilities | (146) | (123) | |||
Net cash used in financing activities | (1,268) | (3,010) | |||
Net decrease in cash, cash equivalents and restricted cash | (264) | (3,819) | |||
Cash, cash equivalents and restricted cash, beginning of year | 3,217 | 6,860 | |||
Cash, cash equivalents and restricted cash, end of period | $ | 2,953 | $ | 3,041 |
SpikeVax® is a registered trademark of Moderna.
Fluzone® is a registered trademark of Sanofi Pasteur.
Fluarix® is a registered trademark of the GlaxoSmithKline group of companies.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp.
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: Moderna's expected revenues in 2023 and 2024; Moderna's ability to launch multiple products in 2024 and 2025 and return to sales growth in 2025; Moderna's future cost of sales; Moderna's expectation to break even in 2026; the sufficiency of Moderna's current cash balances to fund future plans, and Moderna's plans not to raise additional equity; the 2023 U.S. vaccination rate; Spikevax's market share and the ability to continue to gain market share; Moderna's ability to compete in the broader respiratory vaccine commercial market; the anticipated profitability of Moderna's COVID-19 franchise for 2024 and beyond; Moderna's anticipated launches of its RSV vaccine in 2024 with a potential best-in-class profile and its COVID + flu combination vaccine in 2025; Moderna's 2023 through 2025 financial framework; the potential for Moderna to launch up to 15 products in the next five years; the anticipated benefits of combination vaccines; the anticipated initial regulatory approval for mRNA-1083 in 2025; the expectation that Moderna will provide additional data from its Phase 2 INT study in the fourth quarter of 2023; Moderna's and Merck's Phase 3 study of mRNA-4157 in melanoma patients and expected commencement of a Phase 3 trial in NSCLC patients; and Moderna's and Merck's plans to expand the INT development program to additional tumor types. 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, 2022, 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.
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Moderna Contacts
Media:
Chris Ridley
Vice President, Communications
617-800-3651
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
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1 Based on information licensed from IQVIA: IQVIA RAPID Weekly Audit for September/October 2023, reflecting estimates of real-world activity. All rights reserved.
SOURCE: Moderna, Inc.
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