On November 3, 2022 Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported financial results and provided business updates for the third quarter of fiscal year 2022 (Press release, Moderna Therapeutics, NOV 3, 2022, View Source [SID1234623098]).

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"Today’s earnings continue to show strong corporate momentum. With $13.6 billion in product sales through the first three quarters of the year, and advance purchase agreements for anticipated delivery this year now expected to produce around $18 to $19 billion of product sales, we continue to have a strong financial position as we prepare for multiple upcoming global product launches," said Stéphane Bancel, Chief Executive Officer of Moderna. "It has never been clearer that the future of medicine is upon us. As a platform company with scale and resources, Moderna is uniquely positioned to execute on exciting programs in flu, RSV, rare diseases and immuno-oncology, where we have an imminent Phase 2 data read-out. We were also just named a Top Employer by Science for the eighth consecutive year, reflective of the deep commitment of our now more than 3,700 employees globally. There has never been a more promising time for Moderna."

Recent Progress Includes:

Respiratory Vaccines

Received authorization for mRNA-1273.214 booster targeting the BA.1 Omicron subvariant in the United Kingdom, Switzerland, Australia, Canada, European Union and Japan. mRNA-1273.214 induced significantly higher titers than mRNA-1273 against the BA.1 and BA.4/5 Omicron subvariants in a clinical trial conducted before the fall booster season.
mRNA-1273.222 booster, targeting the BA.4/5 Omicron subvariant, is authorized in the United States, European Union, Taiwan and Japan. Phase 2/3 data is expected to be available in the fourth quarter of 2022.
Moderna continues to progress its respiratory vaccine pipeline, including vaccine candidates against influenza, RSV, and combination vaccines. Influenza (mRNA-1010) Phase 3 studies are ongoing. The southern hemisphere immunogenicity study of mRNA-1010 is fully enrolled with approximately 6,000 adult participants, and the data readout is expected in the first quarter of 2023. Initial regulatory feedback supports an accelerated pathway for approval based on this study.
Older adult RSV pivotal Phase 3 trial (mRNA-1345), known as ConquerRSV, is ongoing. Trial has enrolled >35,500 participants. Primary endpoints are safety and vaccine efficacy. The trial data could read out this winter,depending on the number of cases accrued and vaccine effectiveness. Pediatric RSV (mRNA-1345) is in Phase 1 and is now fully enrolled.
Combination COVID + flu (mRNA-1073) Phase 1/2 fully enrolled; combination COVID + flu + RSV (mRNA-1230) has started Phase 1; combination RSV + influenza (mRNA-1045), a new vaccine candidate, has started Phase 1/2 trial.
Latent & Public Health Vaccines:

CMV vaccine (mRNA-1647) pivotal Phase 3 study, known as CMVictory, is ongoing.
Therapeutics

Immuno-oncology

Personalized cancer vaccine (PCV) Phase 2 study evaluating mRNA-4157/V940 in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma is fully enrolled, with the primary efficacy analysis expected in the fourth quarter of 2022. As announced on October 12, Merck has exercised its option to jointly develop and commercialize mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement, and Moderna has received $250 million from Merck in the fourth quarter in connection with the option exercise.
After a portfolio review, AstraZeneca returns rights to the IL-12 program; Moderna is evaluating next steps for the program.
Rare diseases

Phase 1/2 Paramount study of propionic acidemia (PA) candidate (mRNA-3927) isongoing and enrolling additional cohorts. As reported on R&D Day, six patient-years of experience were accrued on drug as of September 8, 2022, with all eligible participants electing to continue on Open Label Extension study. mRNA-3927 has been generally well-tolerated to date and encouraging data has shown a decrease in the number of metabolic decompensation events (MDEs) among participants; initial discussions with regulators are supportive of MDE as a primary endpoint for a pivotal study.
mRNA-3139, for ornithine transcarbamylase (OTC) deficiency, a rare genetic disorder, is in preclinical development.
Moderna now has 48 programs in development across 45 development candidates[1], of which 35 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 130 peer reviewed manuscripts.

Third Quarter 2022 Financial Results

Revenue: Total revenue for the third quarter of 2022 was $3.4 billion compared to $5.0 billion in the same period in 2021, mainly due to a decline in sales of the Company’s COVID-19 vaccines. Product sales for the third quarter of 2022 were $3.1 billion, a decrease of 35%, compared to the same period in 2021, primarily driven by lower sales volume due to the timing of market authorizations for our COVID-19 bivalent boosters and the related manufacturing ramp up.
Cost of Sales: Cost of sales was $1.1 billion, or 35% of product sales, for the third quarter of 2022, including third-party royalties of $106 million. Cost of sales, as a percentage of product sales, increased by 20 percentage points, from 15% in the same period in 2021. This includes a charge of $333 million for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, an expense for unutilized manufacturing capacity of $209 million, and a loss on firm purchase commitments and related cancellation charges of $102 million. These charges are driven by a shift in product demand to our Omicron-targeting COVID-19 bivalent boosters and costs associated with surplus production capacity.
Research and Development Expenses: Research and development expenses for the third quarter of 2022 increased 57% to $820 million, in comparison to the same quarter of 2021. The growth in spending was mainly due to an increase in clinical trial-related expenses, largely driven by increased clinical development activities, particularly with respect to our COVID-19 vaccines, RSV, flu and CMV programs, and increased headcount.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of 2022 increased 65% to $278 million, in comparison to the same quarter of 2021. The growth in spending was mainly due to increased headcount and external spend driven by commercial activities and to accelerate the Company’s build-out.
Effective Tax Rate: The effective tax rate was 14% for the third quarter of 2022, compared to 6% for the same period in 2021. The increase in 2022 was primarily due to the benefit recorded in 2021 related to the release of the valuation allowance on the majority of our deferred tax assets.
Net Income: Net income decreased by 69% to $1.0 billion in the third quarter of 2022, compared to the same period in 2021.
Earnings Per Share: Diluted EPS decreased by 67% to $2.53 in the third quarter of 2022, compared to the same period in 2021.
Cash Position: Cash, cash equivalents and investments as of September 30, 2022 and December 31, 2021 were $17.0 billion and $17.6 billion, respectively.
Net Cash Provided By Operating Activities: Net cash provided by operating activities was $3.3 billion for the nine months ended September 30, 2022, compared to $10.3 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 and increased income tax payments, 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 $308 million for the nine months ended September 30, 2022, compared to $164 million for the same period in 2021. The increase was primarily driven by the Company’s business expansion of its manufacturing and research facilities.
Cash Used for Repurchases of Common Stock: Cash used for repurchases of common stock was $2.9 billion for the nine months ended September 30, 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 third quarter of 2022, the Company repurchased 24 million shares, reducing the number of common shares outstanding from 405 million to 387 million, more than offsetting 5 million shares of common stock issued in connection with equity compensation over this period.
2022 Financial Framework

Advance Purchase Agreements (APAs): Revenue from Moderna’s APAs for product sales for anticipated delivery in 2022 are expected to be $18-19 billion, reflecting deferrals of $2-$3 billion to 2023.
Cost of Sales: Cost of sales as a percentage of product sales are now expected to be 26-28% of sales, with the upper end of the range potentially driven by further charges due to product updates.
Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: Full-year expenses are expected to be approximately $4 billion.
Tax Rate: The Company expects an effective tax rate for the full year in the low- to mid-teen percentage range.
Capital Expenditures: The Company expects capital investments for 2022 of approximately $0.5 billion.
2023 Advanced Purchase Agreements

Confirmed APAs, as well as previously deferred product sales, currently represent $4.5-$5.5 billion in anticipated product sales in 2023. The Company expects additional sales in key markets, including the U.S., E.U., Japan, Middle East, Latin America and Asia Pacific in 2023.
Share Repurchase Program

The $3 billion share repurchase program announced in February 2022 was completed early in the fourth quarter 2022. The Company has commenced repurchases from the additional $3 billion program announced in August 2022.
Corporate Updates

Continued Growth: Moderna had approximately 3,700 employees as of September 30, 2022, compared to approximately 2,400 employees as of September 30, 2021.
Top Employer: Moderna named a Top Employer by Scienceand Science Careers for eighth consecutive year.
R&D Day: On September 8, Moderna held its annual R&D Day to review clinical trial programs across the portfolio, noting early clinical benefits in two rare disease programs, upcoming PCV data and preparation for multiple global product launches.
Executive Committee Appointments and Expansion
On September 6, Jamey Mock was appointed Chief Financial Officer of Moderna, following the retirement of David Meline.
On September 29, Moderna announced that it was expanding its Executive Committee to prepare for new product launches. As part of this expansion, Juan Andres will assume a new role as President, Strategic Partnerships and Enterprise Expansion. Jerh Collins has joined Moderna from Novartis and will succeed Juan Andres as Moderna’s Chief Technical Operations and Quality Officer. These changes will take effect on January 1, 2023.
Key 2022 Investor and Analyst Event Dates

ESG Day: November 10
Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, November 3, 2022.

To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: https://register.vevent.com/register/BI50e67285a997429fb4ca40ef36765c8a
Webcast: View Source
The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.