Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 8, 2024

MODERNA, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38753

81-3467528

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)


200 Technology Square
Cambridge, MA						02139
(Address of principal executive offices)						(Zip code)

Registrant’s telephone number, including area code: (617) 714-6500

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17CFR 240.14d-2(b))


☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0001 per share

MRNA

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On January 8, 2024, Moderna, Inc. (the “Company”) issued a press release (the “Press Release”) in connection with the Company’s presentation on the same date at the 42nd Annual J.P. Morgan Healthcare Conference. The Press Release contains certain preliminary financial information as of and for the fiscal year ended December 31, 2023. Specifically, the Press Release states that (i) the Company generated approximately $6.7 billion in product sales (unaudited) for the fiscal year ended December 31, 2023 from sales of its COVID-19 vaccine, including recognition of approximately $0.6 billion of deferred revenue related to the Company’s efforts with GAVI, The Vaccine Alliance, and (ii) the Company’s current expectation with respect to its cash, cash equivalents and investments in marketable securities (unaudited) as of December 31, 2023 were in excess of $13 billion.

The information in this Item 2.02 is unaudited and preliminary, and does not present all information necessary for an understanding of the Company’s results of operations for the fiscal year ended December 31, 2023, or financial condition as of December 31, 2023. The audit of the Company’s financial statements for the year ended December 31, 2023 is ongoing and could result in changes to the information in this Item 2.02.

Item 7.01 Regulation FD Disclosure.

The disclosure in Item 2.02 above is hereby incorporated by reference into this Item 7.01.

The information contained in Items 2.02 and 7.01, as well as Exhibit 99.1, to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


Exhibit
No.						Description
99.1						Press release by Moderna, Inc. dated January 8, 2024
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: January 8, 2024		MODERNA, INC.

	By:	/s/ Shannon Thyme Klinger
		Shannon Thyme Klinger
		Chief Legal Officer

Exhibit 99.1

Moderna Provides Business and Pipeline Updates at 42nd Annual J.P. Morgan Healthcare Conference

Company announces product sales for 2023 of approximately $6.7 billion (unaudited); U.S. COVID-19 market share season to date increased to 48% in 2023, up from 37% in 2022

Company reiterates 2024 expected product sales of approximately $4 billion, planned return to sales growth in 2025 and expectation to break even in 2026 through product launches and disciplined investment

Company highlights nine late-stage programs with anticipated milestones in 2024 and 2025

CAMBRIDGE, MA / ACCESSWIRE / January 8, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced business updates and progress on the Company’s pipeline of transformative mRNA medicines. Moderna enters 2024 with 45 therapeutic and vaccine programs, nine of which are in late-stage development.

“In 2023, we achieved $6.7 billion in product sales and resized our COVID-19 manufacturing footprint for the endemic setting. Our team significantly increased our COVID-19 market share to 48% in the U.S.,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are preparing for the launch of Moderna’s second product, our RSV vaccine. 2024 is going to be an exciting year for the Company with multiple milestones across our nine late-stage programs. Through these product launches, we are focused on returning to sales growth in 2025.”

Jamey Mock, Chief Financial Officer of Moderna, will present an update on the Company and its pipeline of mRNA development programs on Monday, January 8th, 2024, at 3:45 p.m. PT/6:45 p.m. ET at the 42nd Annual J.P. Morgan Healthcare Conference. A live webcast of both the presentation and the question-and-answer session will be available under “Events and Presentations” in the Investors section of Moderna’s website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

Summary of Financial Updates

2023 financial updates: Moderna achieved 2023 COVID-19 vaccine sales of approximately $6.7 billion (unaudited). This includes approximately $6.1 billion of COVID-19 vaccine sales, and recognition of approximately $0.6 billion of deferred revenue related to the Company’s efforts with GAVI, The Vaccine Alliance. Cash, cash equivalents and investments at year-end 2023 were in excess of $13 billion. Full financial details will be reported on the Company’s earnings call on February 22, 2024.

2024 – 2026 financial framework: The Company expects its COVID-19 franchise to be profitable in its anticipated sales scenarios for 2024 and beyond. Moderna continues to project approximately $4 billion in product sales in 2024, mostly in the second half of the year, primarily due to COVID-19 vaccine sales and the launch of its RSV vaccine. The Company anticipates returning to organic sales growth in 2025 and expects to break even in 2026 through product launches and disciplined investment.

Summary of Upcoming Late-Stage Pipeline Milestones

Moderna expects numerous product milestones in 2024 and 2025 across its vaccines and therapeutics portfolio.

Respiratory vaccines:

•Respiratory syncytial virus (RSV) vaccine: Moderna has filed for regulatory approvals for its vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults ages 60 years or older (mRNA-1345). The Company expects regulatory approvals beginning in the first half of 2024. Moderna will enter the RSV market with a strong competitive profile as the only pre-filled syringe product available at the time of launch, along with robust efficacy data, a well-established safety and tolerability profile, and widespread consumer awareness and demand established in 2023.

•Next-generation COVID-19 vaccine: Moderna’s next-generation, refrigerator-stable COVID-19 vaccine (mRNA-1283) is currently in its pivotal Phase 3 study. The Company anticipates data from the study in the first half of 2024.

•Seasonal flu vaccine: Moderna’s seasonal flu vaccine (mRNA-1010) demonstrated consistently acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 trial (P303), mRNA-1010 met all immunogenicity endpoints, demonstrating higher titers compared to a currently licensed vaccine. mRNA-1010 has also shown higher or comparable titers compared to a currently licensed enhanced vaccine (Fluzone HD®) in a separate Phase 1/2 study. The Company is in discussions with regulators and intends to file in 2024.

•Seasonal flu + COVID vaccine: Moderna’s Phase 3 trial of its combination vaccine against seasonal flu and COVID-19 (mRNA-1083) is fully enrolled. The Company anticipates data from the study in 2024.

Latent and other vaccines:

•Cytomegalovirus (CMV) vaccine: The pivotal Phase 3 study of Moderna's CMV vaccine candidate (mRNA-1647) is fully enrolled and accruing cases, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. The Company anticipates potential efficacy data from the study in 2024.

Oncology therapeutics:

•Individualized Neoantigen Therapy (INT): Moderna continues to demonstrate the potential clinical benefit of its INT program (mRNA-4157). In partnership with Merck, Phase 3 trials continue to enroll in resected high-risk (stage III/IV) melanoma and completely resected stage II, IIIA or IIIB non-small cell lung cancer. Moderna and Merck plan to rapidly expand their clinical studies to additional tumor types in 2024.

The Company recently announced results of a three-year analysis of its Phase 2b study evaluating INT in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma. Compared to KEYTRUDA alone, this combination continued to show an improvement in recurrence-free survival, reducing the risk of recurrence or death by 49%, as well as in distant metastasis-free survival, reducing the risk of developing distant metastasis or death by 62%.

Rare disease therapeutics:

•Propionic acidemia (PA) & methylmalonic acidemia (MMA): The Company expects to advance its PA (mRNA-3705) and MMA (mRNA-3927) programs into pivotal studies in 2024.

Key 2024 Investor and Analyst Event Dates

•Q4 and FY 2023 Earnings Call: February 22, 2024

•Vaccines Day: March 27, 2024

•R&D Day: September 12, 2024

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

SpikeVax® is a registered trademark of Moderna.
Fluzone® is a registered trademark of Sanofi Pasteur.
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 anticipated future revenues, sales growth, profitability and margins; the potential timing for future product approvals and commercial launches; and the advancement of Moderna’s pipeline and late-stage programs, including the commencement of additional clinical trials. 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 those other 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.

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

SOURCE: Moderna, Inc.

Cover	Jan. 08, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Jan. 08, 2024
Entity Registrant Name	MODERNA, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-38753
Entity Tax Identification Number	81-3467528
Entity Address, Address Line One	200 Technology Square
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02139
City Area Code	617
Local Phone Number	714-6500
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, par value $0.0001 per share
Trading Symbol	MRNA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001682852
Amendment Flag	false