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Moderna Reports 2019 Fourth Quarter and Full Year Financial Results and Highlights Advancements in Core Modalities

February 26, 2020 7:00 AM

Two of three dose cohorts in Phase 2 CMV vaccine (mRNA-1647) dose-confirmation study completed enrollment; third and final cohort rapidly enrolling

Up to $2 billion to invest, including cash and investments, financing proceeds and potentially available grants; reiterates guidance that net cash used in operating activities and for purchases of property and equipment is expected to total between $490 million and $510 million in 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today provided business updates and reported financial results for the fourth quarter and full year of 2019 and highlighted pipeline progress.

New updates and recent progress include:

Infectious Diseases

Rare Diseases

Corporate Updates

“The Moderna team continues to execute our strategy, including our CMV Phase 2 study enrolling ahead of plan, shipping the coronavirus Phase 1 clinical materials to NIH/NIAID in just 42 days, and announcing five new development candidates in the last two months,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We have up to $2 billion of capital to invest in the Company, a great team, a powerful mRNA platform and a state-of-the-art manufacturing site. I am more energized than ever about our future.”

Moderna currently has 24 mRNA development candidates in its portfolio with 12 in clinical studies. Across Moderna’s pipeline, more than 1,700 participants have been enrolled in clinical studies. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 40 peer-reviewed papers, including 21 in 2019.

Summary of Program Highlights by Modality

Core Modalities

Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company’s global public health portfolio is focused on epidemic and pandemic diseases for which funding has been sought from government and non-profit organizations.

Infections transmitted from mother to baby

Vaccines against respiratory infections

Vaccines against highly prevalent viral infections

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.

Exploratory Modalities

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.

Information about each development candidate in Moderna’s pipeline, including those discussed in this press release, can be found on the investor relations page of its website: investors.modernatx.com.

Corporate Updates

The Company has established a wide range of strategic alliances with leading biopharmaceutical companies, as well as grants from government-sponsored and private organizations focused on global health initiatives. As of December 31, 2019, Moderna had up to $185 million in additional funding available from grants (including amounts not yet committed)1.

With the offering proceeds, access to additional grant funding, and cash and investments of $1.26 billion as of December 31, 2019, Moderna has access to up to $2 billion in capital to invest in the business.

Key 2020 Investor and Analyst Event Dates

Fourth Quarter and Full Year 2019 Financial Results (Unaudited)

Reiterating Financial Guidance

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, February 26, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 3639288. 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 30 days following the call.

About Moderna

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators. Moderna has 24 mRNA development candidates in its portfolio across all modalities, with 12 in clinical studies. Four of these programs are in or preparing for Phase 2 studies and the Company is preparing for its first Phase 3 study.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. (Nasdaq: AZN) and Merck, Inc. (Nasdaq: MRK), as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

1 Biomedical Advanced Research and Development Authority (BARDA), Defense Advanced Research Projects Agency (DARPA), The Bill and Melinda Gates Foundation (BMGF) and the Coalition for Epidemic Preparedness Innovations. Additional funding is subject to agreement on scope of additional projects.

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, but not limited to, statements concerning: the closing of the sale of additional shares to the underwriters in connection with the Company’s recent public offering, and the net proceeds of the offering following such closing; initiating clinical trial sites outside of the U.S. for mRNA-3704; study start-up for mRNA-3927; finalization of a dose-confirmation Phase 2 study and planning for a pivotal Phase 3 study for mRNA-1647; the availability of additional funding from grants (including amounts not yet committed); the planned Phase 1 clinical trial for mRNA-1273 to be conducted by NIH; the dosing of the final cohorts in the near term for mRNA-1944; the expected initiation of Phase 1 clinical trials for mRNA-6231 and mRNA-6981; and the Company’s expected net cash used in operating activities and for purchases of property and equipment in 2020. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “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: whether the interim Phase 1 results for mRNA-1944 will be predictive of any future clinical studies for mRNA-1944 or other development candidates with the same LNP formulation, including mRNA-3704 and mRNA-3927; preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no mRNA drug has been approved in this new potential class of medicines, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our or filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; and 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 hereof.

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands)

Three Months Ended
December 31,

Years Ended December 31,

2019

2018

2019

2018

Revenue:

Collaboration revenue

$

10,553

$

32,816

$

48,036

$

122,512

Grant revenue

3,502

2,605

12,173

12,556

Total revenue

14,055

35,421

60,209

135,068

Operating expenses:

Research and development

118,754

150,429

496,309

454,082

General and administrative

25,857

38,023

109,620

94,252

Total operating expenses

144,611

188,452

605,929

548,334

Loss from operations

(130,556

)

(153,031

)

(545,720

)

(413,266

)

Interest income

7,984

8,894

38,530

27,023

Other (expense) income, net

(1,837

)

2,879

(7,526

)

1,835

Loss before (benefit from) provision for income taxes

(124,409

)

(141,258

)

(514,716

)

(384,408

)

(Benefit from) provision for income taxes

(169

)

168

(695

)

326

Net loss

$

(124,240

)

$

(141,426

)

$

(514,021

)

$

(384,734

)

Net loss attributable to common stockholders

$

(124,240

)

$

(144,099

)

$

(514,021

)

$

(401,857

)

Net loss per share attributable to common stockholders,
basic and diluted

$

(0.37

)

$

(1.14

)

$

(1.55

)

$

(4.95

)

Weighted average common shares used in net loss per
share attributable to common stockholders, basic and
diluted

334,392,128

126,298,266

330,802,136

81,114,183

MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

(Unaudited, in thousands)

December 31,

2019

2018

Cash, cash equivalents and investments

$

1,262,987

$

1,694,417

Total assets

1,589,422

1,962,149

Total liabilities

414,612

431,908

Total stockholders’ equity

1,174,810

1,530,241

Years Ended December 31,

2019

2018

Net cash used in operating activities

$

(458,968

)

$

(330,865

)

Cash used for purchases of property and equipment (1)

(31,554

)

(105,766

)

(1) Includes $14.6 million and $94.5 million for the years ended December 31, 2019 and 2018, respectively, related to our Moderna Technology Center manufacturing facility.

Moderna

Media:

Colleen Hussey

Senior Manager, Corporate Communications

203-470-5620

[email protected]

Investors:

Lavina Talukdar

Head of Investor Relations

617-209-5834

[email protected]

Source: Moderna, Inc.

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