Moderna Reports Fourth Quarter And Fiscal Year 2020 Financial Results And Provides Business Updates

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.

  • Propionic acidemia (PA) (mRNA-3927): Study start-up activities for the Phase 1/2 study of PA candidate (mRNA-3927) have resumed following COVID-19 related pause and protocol amendment. mRNA-3927 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3927.
  • Methylmalonic acidemia (MMA) (mRNA-3705): Moderna received rare pediatric designation for its next generation MMA candidate (mRNA-3705). The Company plans to file new IND and CTA applications for mRNA-3705 and will focus development efforts on that candidate going forward. mRNA-3705 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3705.
  • Phenylketonuria (PKU) (mRNA-3283): Individuals with PKU have a deficiency in phenylalanine hydroxylase (PAH) resulting in a reduced or complete inability to metabolize the essential amino acid phenylalanine into tyrosine. mRNA-3283 encodes human PAH to restore the deficient or defective intracellular enzyme activity in patients with PKU. mRNA-3283 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3283.
  • Glycogen storage disease type 1a (GSD1a) (mRNA-3745): Individuals with GSD1a have a deficiency in glucose-6-phosphatase resulting in pathological blood glucose imbalance. mRNA-3745 is an IV-administered mRNA encoding human G6Pase enzyme, designed to restore the deficient or defective intracellular enzyme activity in patients with GSD1a. mRNA-3745 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3745.

Information about each development candidate in Moderna’s pipeline can be found on the investor relations page of its website: investors.modernatx.com.

Fourth Quarter and Full Year 2020 Financial Results (Unaudited)

  • Cash Position: Cash, cash equivalents and investments as of December 31, 2020 and 2019 were $5.25 billion and $1.26 billion, respectively.
  • Net Cash Provided by (Used in) Operating Activities: Net cash provided by operating activities was $2.03 billion for the year ended December 31, 2020 compared to net cash used in operating activities of $(459) million for the year ended December 31, 2019.
  • Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $67 million for the year ended December 31, 2020 compared to $32 million for the same period in 2019.
  • Revenue: Total revenue was $571 million for the fourth quarter of 2020 compared to $14 million for the fourth quarter of 2019. Total revenue was $803 million for the year ended December 31, 2020 compared to $60 million for the year ended December 31, 2019. The increases in both periods in 2020 were driven by increases in grant revenue and product sales. The increase in grant revenue was primarily due to the BARDA award to accelerate development of our COVID-19 vaccine. We began to recognize revenue in December 2020 from our COVID-19 vaccine subsequent to its authorization for emergency use by the FDA and Health Canada.
  • Cost of Sales: Costs of sales were $8 million, or 4% of Moderna’s product sales, in 2020, primarily comprised of third-party royalties as the associated inventory costs were expensed previously. If inventory sold during 2020 was valued at cost, Moderna’s cost of sales for 2020 would have been $62 million, or 31% of Moderna’s product sales.
  • Research and Development Expenses: Research and development expenses were $759 million for the fourth quarter of 2020 compared to $118 million for the fourth quarter of 2019. Research and development expenses were $1.37 billion for the year ended December 31, 2020 compared to $496 million for the year ended December 31, 2019. The increases in 2020 were largely attributable to mRNA-1273 clinical development, pre-launch inventory buildup prior to the emergency use authorization from the FDA and to a lesser extent, an increase in personnel related costs, primarily driven by an increase in the number of employees supporting our mRNA-1273 development activities.
  • Selling, General and Administrative Expenses: Selling, general and administrative expenses were $79 million for the fourth quarter of 2020 compared to $26 million for the fourth quarter of 2019. Selling, general and administrative expenses were $188 million for the year ended December 31, 2020 compared to $110 million for the year ended December 31, 2019. The increases in 2020 were mainly due to an increase in personnel costs, and outside services, primarily attributable to increased headcount and mRNA-1273 vaccine candidate commercialization-related activities.
  • Net Loss: Net loss was $272 million for the fourth quarter of 2020 compared to $123 million for the fourth quarter of 2019. Net loss was $747 million for the year ended December 31, 2020 compared to $514 million for the year ended December 31, 2019.

Moderna’s COVID-19 Vaccine Supply Agreements & Regulatory Updates

Moderna has confirmed the following supply agreements of committed orders:

  • United States: 300 million doses with options to purchase an additional 200 million doses; the U.S. Food and Drug Administration (FDA) has authorized emergency use in individuals 18 years of age and older
  • European Union: 310 million doses with option to purchase an additional 150 million doses in 2022; the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna in individuals 18 years of age and older1
  • Japan: 50 million doses
  • Canada: 44 million doses; Health Canada authorized COVID-19 Vaccine Moderna for the immunization of people 18 years of age and older under an Interim Order
  • Republic of Korea: 40 million doses
  • United Kingdom: 17 million doses; the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the COVID-19 Vaccine Moderna for use under Regulation 174, a temporary authorization
  • Switzerland: 13.5 million doses; Swissmedic, the Swiss Agency for Therapeutic Products, authorized the COVID-19 Vaccine Moderna in Switzerland
  • Colombia: 10 million doses
  • Israel: 6 million doses; Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna
  • Taiwan: 5 million doses
  • Singapore: (undisclosed); the Singapore Health Sciences Authority (HSA) approved the interim authorization of the COVID-19 Vaccine Moderna for use under the Pandemic Special Access Route (PSAR)
  • Qatar (undisclosed); the Qatar Ministry of Public Health issued an emergency use authorization for the COVID-19 Vaccine Moderna

Management Updates

  • Moderna’s Chief Medical Officer (CMO), Tal Zaks, M.D., Ph.D., will be leaving the Company in late September after six years of service. The Company has retained Russell Reynolds to recruit for a new CMO with global and commercial experience as the Company scales up the launch of its COVID-19 Vaccine and prepares to file several biologics license applications (BLAs) over the next few years.

“I would like to thank Tal for his tremendous impact on Moderna’s success over the last six years. Tal joined us when we were a pre-clinical company. His guidance and contributions were important in helping Moderna get to where we are today. Through his leadership over the past year in Moderna’s response to the COVID-19 pandemic, Tal has made a contribution that extends beyond Moderna to all of society. I have enjoyed having him as my partner and wish him all the best as he embarks on the next leg of his career,” said Stéphane Bancel.

  • Corinne Le Goff, Pharm.D., M.B.A., joined Moderna as the Company’s first Chief Commercial Officer on January 19, 2021. Dr. Le Goff previously served as SVP and President U.S. Business Organization at Amgen (Nasdaq: AMGN). During her nearly 6-year tenure at Amgen, she also served as SVP of the Europe Region and oversaw 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for innovative, high-quality and affordable healthcare.

2020 Commercial Network

The Company started to build a global commercial network. This infrastructure will enable Moderna’s entire portfolio, which means that Moderna can commercialize its entire pipeline without a large pharmaceutical partner. The Company now has subsidiaries, distributors or partners in the following geographies:

  • Moderna USA
  • Moderna Canada
  • Moderna France
  • Moderna Germany
  • Moderna Italy
  • Japan (Partner: Takeda)
  • Moderna Spain
  • Moderna UK
  • Moderna Switzerland

Corporate Updates

  • Shareholder letter: Moderna CEO Stéphane Bancel published a letter to shareholders on January 4, 2021.
  • Annual Meeting of Shareholders: The Moderna Annual Meeting of Shareholders will be held on April 28, 2021 at 8:00 a.m. ET. The meeting will be held virtually at www.virtualshareholdermeeting.com/MRNA2021. The record date for voting or attendance as a stockholder is 4:00 p.m. ET on March 1, 2021.

2021 Financial Considerations

  • Advance Purchase Agreements (APAs): Already signed APAs for scheduled delivery in 2021, reflecting a total of $18.4 billion in anticipated product sales. Additional discussions ongoing with several governments relating to APAs for scheduled deliveries in 2021 and 2022. Moderna responded to a tender to UNICEF to supply COVAX in 2021 and 2022 and discussions are ongoing with COVAX/UNICEF.
  • Cost of Sales: Expected at approximately 20% of product sales for fiscal year 2021.
  • 2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: For the first quarter 2021, expect low double-digit percent increase versus adjusted fourth quarter 2020 results of $0.5 billion. The fourth quarter 2020 reported expense was $0.8 billion. Adjusted Q4 expense, totaling $0.5 billion, excludes $0.3 billion of reported expenses, which are now capitalized and expensed through cost of sales, based on our change from a research and development to a commercial organization.
  • Tax Rate: Effective tax rate expected in the mid-teen percentage level as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of $2.3 billion.
  • Capital Expenditures: $350-400 million of capital investments currently planned for 2021.
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