May 4, 2022, 6:52 a.m. EDT

Moderna Reports First Quarter 2022 Financial Results and Provides Business Updates

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May 04, 2022 (ACCESSWIRE via COMTEX) -- First quarter 2022 revenues of $6.1 billion; GAAP net-income of $3.7 billion and GAAP diluted EPS of $8.58

Moderna reiterates its 2022 signed advance purchase agreements of approximately $21 billion

Company expects to have four programs in Phase 3 in the second quarter: Omicron-containing bivalent COVID booster, flu, RSV, CMV

CAMBRIDGE, MA / ACCESSWIRE / May 4, 2022 / Moderna, Inc . /zigman2/quotes/205619834/composite MRNA +0.76% , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the first quarter of fiscal year 2022.

"The Moderna team delivered a strong Q1 performance and I am thankful for the progress our team continues to make as we advance our pipeline of mRNA medicines. Today, we are reiterating our signed advanced purchase agreements for 2022 of $21 billion. In the second quarter, we expect to have four programs in late-stage Phase 3 studies including our Omicron-containing bivalent COVID booster, seasonal flu, RSV and CMV vaccine candidates.Beginning in the fall of 2022, our robust Phase 3 pipeline could lead to three respiratory commercial launches over the next two to three years. We also look forward to advancing our therapeutic programs and sharing proof-of-concept readouts on our rare genetic disease programs for propionic acidemia and methylmalonic acidemia, and on our personalized cancer vaccine program this year," said Stéphane Bancel, Chief Executive Officer of Moderna. "I would like to thank the global Moderna team for their commitment to our mission. mRNA has changed the future of medicine and I look forward to continuing our impact on human health. This is just the beginning."

Recent progress includes:

Respiratory Vaccines

  • Submitted a EUA request to U.S. FDA for a 25 μg two-dose primary series of mRNA-1273 in children 6 months to under 6 years of age; similar requests underway with international regulatory authorities

  • Positive initial data on booster dose of bivalent candidate based on the wild-type and Beta variant (mRNA-1273.211)

  • Positive Phase 2 interim analysis of seasonal flu vaccine candidate (mRNA-1010); Phase 3 study in the Southern Hemisphere expected to begin in the second quarter

  • Moderna continues to progress respiratory vaccine pipeline with positive Phase 1 data on next-generation, refrigerator-stable COVID vaccine candidate (mRNA-1283), a new combination respiratory vaccine candidate (mRNA-1230) against SARS-CoV-2 virus, influenza virus and RSV and a new vaccine candidate (mRNA-1287) against the four endemic human coronaviruses (HCoV-229E, -NL63, -OC43 and -HKU1)

Latent Vaccines

  • First participants dosed in Phase 1 study of HIV vaccine candidate with germline targeting approach (mRNA-1644)

  • First participants dosed in Phase 1 study of HIV trimer mRNA vaccine candidate (mRNA-1574)

Public Health Vaccines

  • The U.S. FDA completed its review of the investigational new drug (IND) application of Moderna's Nipah virus vaccine candidate (mRNA-1215), allowing it to proceed to clinic

Therapeutics

  • The first cohort of the Phase 1/2 Paramount study of propionic acidemia candidate (mRNA-3927) is fully enrolled. Moderna is enrolling patients into additional cohorts. All five patients eligible for the Open Label Extension (OLE) study have elected to participate.

  • The first cohort of the Phase 1/2 Landmark study of methylmalonic acidemia candidate (mRNA-3705) is fully enrolled. Moderna is enrolling patients into additional cohorts. The one patient eligible to participate in the OLE study has elected to participate.

Moderna now has 46 programs in development across 43 development candidates [1] , of which 29 are currently in active clinical trials. The Company's updated pipeline can be found at www.modernatx.com/pipeline . Moderna and collaborators have published more than 115 peer reviewed manuscripts.

First Quarter 2022 Financial Results

  • Revenue: Total revenue was $6.1 billion for the first quarter of 2022, compared to $1.9 billion for the same period in 2021. The increase in 2022 was primarily due to increased product sales. Product sales for the first quarter of 2022 were $5.9 billion from sales of the Company's COVID vaccine, compared to $1.7 billion in the first quarter of 2021.

  • Cost of Sales: Cost of sales was $1.0 billion, or 17%, of product sales for the first quarter of 2022, including third-party royalties of $207 million. Cost of sales was $193 million, or 11%, of product sales, for the first quarter of 2021. The increase in cost of sales as a percentage of product sales in 2022 was mainly driven by the lack of the pre-launch inventory benefit (that impacted the first quarter of 2021), coupled with inventory write-downs and a current period expense related to firm purchase commitments. The increase was partially offset by a favorable customer mix, and benefits from the scale up of our manufacturing processes. If inventory sold for the three months ended March 31, 2021 was valued at cost, Moderna's cost of sales for the period would have been $377 million, or 22%, of the Company's product sales.

  • Research and Development Expenses: Research and development expenses were $554 million for the first quarter of 2022, compared to $401 million for the same period in 2021. The increase in spending in 2022 was mainly due to increases in personnel-related costs, clinical trial expenses, technology and facility-related costs, and consulting and outside services.

  • Selling, General and Administrative Expenses: Selling, general and administrative expenses were $268 million for the first quarter of 2022, compared to $77 million for the same period in 2021. The growth in spending in 2022 was mainly due to an endowment to the Moderna Charitable Foundation and increases in distributor fees, personnel-related costs, and consulting and outside services.

  • Provision for Income Taxes: The effective tax rate was 14% for the first quarter of 2022, compared to 3% for the same period in 2021. Income taxes were $572 million for the first quarter of 2022, compared to $39 million for the same period in 2021. The increase in income tax provision was primarily due to an increase in pre-tax income and a higher effective tax rate in 2022, as 2021 included tax benefits related to the release of the valuation allowance on the majority of our deferred tax assets.

  • Net Income: Net income was $3.7 billion for the first quarter of 2022, compared to $1.2 billion for the same period in 2021.

  • Earnings Per Share: Diluted EPS was $8.58 for the first quarter of 2022, compared to $2.84 for the same period in 2021.

  • Cash Position: Cash, cash equivalents and investments as of March 31, 2022 and December 31, 2021 were $19.3 billion and $17.6 billion, respectively.

  • Net Cash Provided by Operating Activities: Net cash provided by operating activities was $2.8 billion for the three months ended March 31, 2022, compared to $3.0 billion for the same period in 2021. Net cash provided by operating activities decreased in 2022, primarily attributable to revenue recognized from deferred revenue in excess of customer deposits received, partially offset by increased product sales and higher collection of receivables.

  • Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $132 million for the three months ended March 31, 2022, compared to $35 million for the same period in 2021. The increase was primarily driven by the Company's business expansion.

  • Cash Used for Repurchase of Common Stock: Cash used for repurchases of common stock was $623 million for the three months ended March 31, 2022. Moderna did not conduct share repurchases prior to the fourth quarter of 2021. From the end of the third quarter of 2021 to the end of the first quarter of 2022, the Company repurchased 7 million shares, reducing the number of common shares outstanding from 405 million to 400 million, more than offsetting 2 million shares of common stock issued in connection with equity compensation over this period.

2022 Financial Framework

  • Advanced Purchase Agreements (APAs): Moderna's 2022 APAs for product sales are approximately $21 billion. Moderna believes that COVID market dynamics will result in sales slightly larger in the second half of 2022 than in the first half.

  • Cost of Sales: Cost of sales as percentage of product sales are expected to be in the low-to-mid 20s percentage range.

  • Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses : Full year expenses expected to be approximately $4 billion.

  • Tax Rate: The Company expects an effective tax rate for the full year in the mid-teen percentage range.

  • Capital Expenditures: Expect capital investments for 2022 in the range of $0.6-$0.8 billion.

  • Share Repurchase Program: As announced last quarter, the Board of Directors authorized a share repurchase program for $3 billion in February 2022 to return excess capital to shareholders. The previous program of $1 billion announced in August 2021 has been fully utilized as of the end of January 2022.

Management Updates

  • Jorge Gomez will join Moderna as Chief Financial Officer effective May 9, 2022. He will serve on Moderna's Executive Committee and report to Chief Executive Officer, Stéphane Bancel. Mr. Gomez joins Moderna from Dentsply Sirona, Inc. /zigman2/quotes/204544124/composite XRAY -0.08% where he served as Executive Vice President & Chief Financial Officer since August 2019. At Dentsply Sirona, he was responsible for leading the global finance organization, including strategic finance, FP&A, Accounting, Treasury, Tax, Corporate Audit and Investor Relations, and the Information Technology function. In addition, Mr. Gomez was responsible for leading Dentsply Sirona's sustainability and ESG program. David Meline, Moderna's current CFO, has decided to retire and will remain with the Company as a consultant to ensure a smooth transition of the CFO role to Mr. Gomez.

    "I am very thankful to David for having decided to come out of retirement for two years in the spring of 2020 to help us get Moderna ready for commercialization in record time. Moderna was an early-stage development, U.S. focused company when David joined us. He goes back into retirement after having helped transform Moderna into a global commercial company. He has built a great team and strong financial business processes. It has been a pleasure to work with him, and I wish him and his wife a wonderful time," said Stéphane Bancel.

  • Arpa Garay will join Moderna as Chief Commercial Officer effective May 31, 2022. She will serve on Moderna's Executive Committee and report to Chief Executive Officer, Stéphane Bancel. Ms. Garay joins Moderna from Merck & Co., Inc. (MRK) where she most recently served as Chief Marketing Officer for Merck's Human Health business; she reported to Merck's Chief Executive Officer and was a member of Merck's Executive Committee. Additionally, she was responsible for data & analytics, digital marketing, and precision medicine worldwide. She also served as President of Global Pharmaceuticals, Analytics, and Digital Marketing; SVP & Head of U.S. Vaccines; and General Manager of Merck & Co. in Norway.

    "I am very pleased to welcome Arpa to Moderna as our Chief Commercial Officer and to the Executive Committee. Arpa brings extensive experience leading commercial teams at global biopharmaceutical companies in an evolving global healthcare environment. Arpa is an innovative thinker with digital expertise and broad international experience, having lived in many countries. I look forward to partnering with Arpa as we advance our mission of delivering on the promise of mRNA medicines for people around the world."

Corporate Updates

  • Continued Growth: Moderna now has approximately 3,200 full time employees, compared to approximately 1,500 employees as of March 31, 2021.

  • Moderna Enterprise Solutions Hub in Atlanta: Moderna announced plans to establish an Enterprise Solutions Hub in Atlanta, Georgia. Moderna's Atlanta office will initially host finance, human resources, procurement, and digital functions.

  • mRNA Manufacturing Facility in Canada: Moderna announced plans to build a state-of-the-art mRNA vaccine manufacturing facility in Quebec that will support a long-term strategic partnership with the Government of Canada to enhance pandemic preparedness.

  • mRNA Facility in Australia: Moderna announced the finalization of a strategic partnership with the Australian Federal Government to establish a state-of-the-art, domestic mRNA vaccine manufacturing facility in Australia.

  • mRNA Manufacturing Facility in Kenya: Moderna announced it has entered into a Memorandum of Understanding with the Government of the Republic of Kenya to establish Kenya as the location for the Company's mRNA manufacturing facility.

  • Global Public Health Strategy: Moderna announced its global public health strategy through four new initiatives aimed at advancing mRNA vaccines for the prevention of infectious diseases, including a new program, that will offer researchers use of Moderna's mRNA technology to explore new vaccines against emerging or neglected infectious disease

  • Company Recognition: Moderna was named one of TIME Magazine's most influential companies of 2022.

Key 2022 Investor and Analyst Event Dates

  • Science Day: May 17

  • R&D Day: September 8

  • ESG Day: November 10

Summary of Program Highlights by Modality2

Core Modalities

Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is an unmet medical need, including vaccines against respiratory infections and vaccines against latent viruses.

Vaccines against acute respiratory infections

  • Moderna COVID Vaccine (mRNA-12733, Spikevax ®): The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID in individuals 18 years of age and older.

  • Moderna COVID Vaccine for adolescents and children: Moderna has received regulatory authorizations for the use of the 100 µg Moderna COVID vaccine primary series for adolescents 12 to 17 years of age in more than 40 countries. The Company has received authorization for a two-dose 50 µg primary series of mRNA-1273 in children ages 6 to 11 in more than 35 countries. Moderna submitted a request for emergency use authorization (EUA) for a 25 μg two-dose primary series of mRNA-1273 in children 6 months to 6 years of age to the U.S. FDA; similar requests are underway with international regulatory authorities. The Company has initiated an EUA submission with the U.S. FDA for a 50 μg two-dose primary series of mRNA-1273 in children 6-11 years of age. For the adolescent age group, Moderna recently expanded its previous EUA submission for a two-dose 100 μg primary series of mRNA-1273 with a follow-up of clinical safety and efficacy data at FDA's request, which is now under review. These submissions will be completed in approximately 2 weeks with the submission of the statistical packages.

  • Next-generation vaccine against COVID (mRNA-1283): In a Phase 1 study of mRNA-1283, preliminary results indicate that when administered as primary series at lower doses levels (10 µg, 30 µg), mRNA-1283 elicits a robust anti-SARS-CoV-2 neutralizing antibody response comparable to the 100 µg mRNA-1273 primary series. The frequency of local and systemic solicited adverse reactions of the mRNA-1283 primary series administered at lower dose levels (10 µg, 30 µg) was overall comparable to mRNA-1273. Enrollment is complete in a Phase 2 study evaluating booster doses of mRNA-1283, mRNA-1283.211, and mRNA-1283.529. mRNA-1283 is a next-generation vaccine candidate against COVID that encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain (NTD). The encoded mRNA-1283 antigen is shorter than mRNA-1273 and is being developed as a potential refrigerator-stable mRNA vaccine that will facilitate easier distribution and administration by healthcare providers.

/zigman2/quotes/205619834/composite
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June 27, 2022 4:00p
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Market Cap
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Rev. per Employee
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