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Moderna Reports First Quarter 2020 Financial Results and Provides Business Updates

May 7, 2020 7:00 AM

Progress on novel coronavirus vaccine (mRNA-1273) includes FDA clearance to proceed with Phase 2 study

Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020

Awarded up to $483 million funding from BARDA for accelerated development of mRNA-1273

Entered strategic collaboration with Lonza Ltd. to manufacture up to one billion doses of mRNA-1273 per year

Up to $2.4 billion to invest, including cash and investments of $1.7 billion and up to $0.7 billion in potentially available grants and awards; reconfirms 2020 guidance that net cash used in operating activities and for purchases of property and equipment is expected to be approximately $500 million

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 reported financial results and provided business updates for the first quarter of 2020 and highlighted pipeline progress.

“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021. We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We also are continuing to progress our development pipeline and invest in our future. We are very pleased with Vertex’s decision, based on our preclinical progress, to extend our strategic collaboration working to develop the technology to allow for delivery of mRNA in the lung.”

New updates and recent progress include:

Infectious Diseases

Oncology

Rare Diseases

Research Update

Moderna currently has 23 mRNA development candidates in its portfolio with 13 in clinical studies. Across Moderna’s pipeline, more than 1,900 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 45 peer-reviewed papers.

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 governments 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.

Research Update

Management Updates

Corporate Updates

Financial Guidance

Key 2020 Investor and Analyst Event Dates

First Quarter 2020 Financial Results (Unaudited)

MODERNA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except share and per share data)

Three Months Ended March 31,

2020

2019

Revenue:

Collaboration revenue

$

4,457

$

14,115

Grant revenue

3,932

1,910

Total revenue

8,389

16,025

Operating expenses:

Research and development

115,137

130,413

General and administrative

24,114

27,253

Total operating expenses

139,251

157,666

Loss from operations

(130,862

)

(141,641

)

Interest income

7,852

10,972

Other expense, net

(1,154

)

(1,931

)

Loss before income taxes

(124,164

)

(132,600

)

Provision for (benefit from) income taxes

66

(24

)

Net loss

$

(124,230

)

$

(132,576

)

Net loss per share, basic and diluted

$

(0.35

)

$

(0.40

)

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

353,105,021

328,809,986

MODERNA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

(Unaudited, in thousands)

March 31,

December 31,

2020

2019

Cash, cash equivalents and investments

$

1,720,180

$

1,262,987

Total assets

2,067,541

1,589,422

Total liabilities

426,667

414,612

Total stockholders’ equity

1,640,874

1,174,810

Total liabilities and stockholders’ equity

2,067,541

1,589,422

Three Months Ended March 31,

2020

2019

Net cash used in operating activities

$

106,191

$

144,268

Cash used for purchases of property and equipment

6,223

7,595

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 7, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 6698719. 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. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

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.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., 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) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

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 impact of the SARS-CoV-2 pandemic on the Company’s clinical trials and operations, including mRNA-1653, mRNA-3704, mRNA-3927, mRNA-3630 and mRNA-1944; the status, timing and results of the Phase 1 trial of mRNA-1273 being conducted by the NIH; the timing of and proposed design for the planned Phase 2 study of mRNA-1273; the next steps, including the Phase 3 study design and the timing thereof, and ultimate commercial plan for mRNA-1273; the ability to scale dosing capacity for mRNA-1273; the size of the potential market opportunity for mRNA-1273; the timing and results of the Phase 2 dose confirmation study of mRNA-1647; the timing and design of the Phase 3 study of mRNA-1647; the Company’s intention to create a combination therapy with mRNA-1345 and mRNA-1653 against RSV, hMPV and PIV3; the timing and status of the Phase 1 study of mRNA-6231 in healthy volunteers; the continuing success of the extended strategic collaboration with Vertex; the probability of success of the Company’s vaccines individually and as a portfolio; and the ability of the Company to accelerate the research and development timeline for any individual product or the platform as a whole. 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-1893 will be predictive of study results and any future clinical studies for mRNA-1893 or other development candidates; 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 commercial product using mRNA technology has been approved , 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 the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; 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.

Media:

Colleen Hussey

Senior Manager, Corporate Communications

203-470-5620

[email protected]

Dan Budwick

1AB

973-271-6085

[email protected]

Investors:

Lavina Talukdar

Head of Investor Relations

617-209-5834

[email protected]

Source: Moderna, Inc.

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