01—Abstract
Summary
Summary of the 10-Q filed May 7, 2020. Cited figures are marked; the original filing is the authoritative source.
Moderna, Inc. (MRNA) filed its 10-Q for the period ending March 31, 2020, on May 7, 2020.
The filing highlights the company's significant cash position ($1.72 billiona) which management believes is sufficient to fund operations for at least the next 12 months. However, the company is still in the early stages of drug development and has incurred substantial losses since its inception, anticipating continued losses for the foreseeable future. A major focus is the development of mRNA-1273, a potential vaccine for COVID-19, which is in early clinical stages and receiving significant government funding and collaboration.
The company emphasizes that the success of mRNA-1273, and indeed any mRNA drug, faces substantial clinical development and regulatory risks, as no mRNA drug has been approved to date. The report extensively details numerous risks, including the ongoing COVID-19 pandemic's impact on clinical trials and operations, supply chain disruptions, potential delays in regulatory pathways, and the need for significant future funding.
Moderna also flags competition, intellectual property challenges, reliance on third parties for manufacturing and trials, and the inherent uncertainties of developing a novel class of medicines. Investors should note that the company has no product sales revenue and is not yet profitable, with future success heavily dependent on successful clinical development and regulatory approvals.
02—Key points
Key Highlights
- Moderna reported $1.72 billion in cash, cash equivalents, and investments as of March 31, 2020, which is expected to fund operations for at least the next 12 months.
- The company is actively developing mRNA-1273, a potential vaccine for COVID-19, with significant collaborations and government funding (e.g., BARDA, NIAID).
- Despite progress, Moderna has incurred significant losses since inception and anticipates continued losses for the foreseeable future, with no product sales revenue generated to date.
- The development of mRNA-based therapies faces substantial clinical, regulatory, and manufacturing risks, as no mRNA drug has yet been approved by regulatory agencies.
- The COVID-19 pandemic poses significant risks, including delays in clinical trials, manufacturing disruptions, and potential impacts on global financial markets and access to capital.
- The company faces numerous other risks including competition, intellectual property challenges, reliance on third-party manufacturers and collaborators, and the inherent uncertainties of novel drug development.
03—One dollar
04—Financials
Financial Highlights
Figures from 10-QQ1 FY2020filed May 7, 2020Financial Statements
Q1 FY2020 against Q1 FY2019
| Line item | Q1 FY2020Q1 FY2019 | Change |
|---|---|---|
| Revenue | $8.00M$16.02M | −50.1% |
| Cost of Revenue | $0— | — |
| Gross Profit | $8.00M— | — |
| R&D Expenses | $115.00M$130.41M | −11.8% |
| Operating Expenses | $139.00M$157.67M | −11.8% |
| Operating Income | -$131.00M-$141.64M | +7.5% |
| Net Income | -$124.00M-$132.58M | +6.5% |
| EPS (Basic) | $-0.35$-0.40 | +12.5% |
| EPS (Diluted) | $-0.35— | — |
| Shares Outstanding (Basic) | 353.00M328.81M | +7.4% |
| Shares Outstanding (Diluted) | 353.00M— | — |
05—Questions
Frequently Asked Questions
What is Moderna's current financial position and funding outlook?
As of March 31, 2020, Moderna held approximately $1.72 billion in cash, cash equivalents, and investments. The company believes this is sufficient to fund its operations for at least the next 12 months. However, it anticipates continued significant losses and expects to finance future needs through equity/debt offerings, structured financings, government funding, and strategic alliances, noting that additional capital may not always be available on reasonable terms.
What is the status and outlook for Moderna's COVID-19 vaccine candidate (mRNA-1273)?
Moderna is rapidly pursuing the development and clinical testing of mRNA-1273, a potential vaccine for COVID-19. The development is in early stages, involving collaborations with the National Institute of Allergy and Infectious Diseases (NIAID). While significant funding and partnerships are in place (e.g., from BARDA and CEPI), the company emphasizes that it may be unable to produce a successful vaccine in a timely manner, if at all. The scalability of manufacturing and regulatory pathway also present key challenges.
What are the primary risks highlighted in this filing?
The filing extensively details numerous risks. Key among them are the ongoing impact of the COVID-19 pandemic on clinical trials and operations, the inherent risks of developing novel mRNA medicines (including lack of prior approvals), manufacturing and supply chain challenges, intense competition, intellectual property disputes, reliance on third-party collaborators and manufacturers, and the need for significant future funding. The company has a history of net losses and expects this to continue.
Has Moderna generated any revenue from product sales?
No, Moderna has not generated any revenue from product sales to date and anticipates significant operating losses for the foreseeable future. Its operations have been financed primarily through equity securities sales, strategic alliances, and grants.
06—Continue