Annual Statements Open main menu
  1. Annual Statements
  2. » Companies
  3. » Moderna, Inc.
  4. » Quarter Report: 2024 June (Form 10-Q)

Moderna, Inc. - Quarter Report: 2024 June (Form 10-Q)

Total revenue    Operating expenses:Cost of sales    Research and development    Selling, general and administrative    Total operating expenses    Loss from operations()()()()Interest income    Other (expense) income, net() ()()Loss before income taxes()()()()Provision for (benefit from) income taxes () ()Net loss$()$()$()$()Net loss per share:
Basic and diluted
$()$()$()$()
Weighted average common shares used in calculation of net loss per share:
Basic and diluted
    


The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
Table of Contents
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited, in millions)
Common StockAdditional
Paid-In
Capital		Accumulated Other Comprehensive LossRetained EarningsTotal
Stockholders’
Equity
SharesAmount
Balance at March 31, 2024 $ $ $()$ $ 
Exercise of options to purchase common stock —  — —  
Issuance of common stock under employee stock purchase plan— —  — —  
Stock-based compensation— —  — —  
Other comprehensive income, net of tax— — —  —  
Net loss— — — — ()()
Balance at June 30, 2024 $ $ $()$ $ 


Common StockAdditional
Paid-In
Capital		Accumulated
Other
Comprehensive
Loss		Retained EarningsTotal
Stockholders’
Equity
SharesAmount
Balance at March 31, 2023 $ $ $()$ $ 
Exercise of options to purchase common stock —  — —  
Issuance of common stock under employee stock purchase plan— —  — —  
Stock-based compensation— —  — —  
Other comprehensive income, net of tax— — —  —  
Repurchase of common stock()— ()— — ()
Net loss— — — — ()()
Balance at June 30, 2023 $ $ $()$ $ 



8
Table of Contents


Common StockAdditional
Paid-In
Capital		Accumulated
Other
Comprehensive
Loss		Retained EarningsTotal
Stockholders’
Equity
SharesAmount
Balance at December 31, 2023 $ $ $()$ $ 
Vesting of restricted common stock — — — — — 
Exercise of options to purchase common stock —  — —  
Issuance of common stock under employee stock purchase plan— —  — —  
Stock-based compensation— —  — —  
Other comprehensive income, net of tax— — —  —  
Net loss— — — — ()()
Balance at June 30, 2024 $ $ $()$ $ 


Common StockAdditional
Paid-In
Capital		Accumulated
Other
Comprehensive
Loss		Retained EarningsTotal
Stockholders’
Equity
SharesAmount
Balance at December 31, 2022 $ $ $()$ $ 
 ) 

Payments and returns related to sales made in current period  
Payments and returns related to sales made in prior year
 Balance at June 30, 2024$()

 $ $ $ Collaboration revenue    
Licensing and royalty revenue
    Total other revenue$ $ $ $ 

Grant Revenue

In April 2020, we entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), for an award of up to $ million to accelerate development of mRNA-1273. The agreement has been subsequently amended to provide for additional commitments to support various late-stage clinical development efforts of our original COVID-19 vaccine, mRNA-1273, including a participant Phase 3 study, pediatric clinical trials, adolescent clinical trials and pharmacovigilance studies. The maximum award from BARDA, inclusive of all amendments, was approximately $ billion. All contract options have been exercised. As of June 30, 2024, the remaining available funding, net of revenue earned was $ million.

In June 2024, we were awarded up to $ million through the Rapid Response Partnership Vehicle (RRPV), funded by BARDA, to accelerate the development of mRNA-based pandemic influenza vaccines. The project award will support the late-stage development of an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against the H5 influenza virus. This subtype of the influenza virus causes a highly infectious and severe disease in birds known as avian influenza and poses a risk of spillover into the human population. The agreement also includes additional options to prepare for and accelerate responses to future public health threats. We had not recognized any revenue under this agreement as of June 30, 2024.

Licensing and Royalty Revenue

In April 2024, we entered a non-exclusive out-licensing agreement with a pharmaceutical company based in Japan for mRNA COVID-19-related intellectual property for the territory of Japan. Under the terms of the agreement, we received an upfront payment of $ million, which included a $ million prepayment creditable against future royalties. Additionally, we are entitled to receive low double-digit royalties on the net sales of the company’s COVID-19 product.

 million of the upfront payment as other revenue in our condensed consolidated statements of operations. The remaining $ million was recorded as deferred revenue in our condensed consolidated balance sheets. Royalty revenue will be recognized when the underlying sales occur.

14
Table of Contents
 million. Following this exercise, the Merck Participation Term commenced. Pursuant to the agreement, we and Merck have agreed to collaborate on further development and commercialization of INT, with costs and any profits or losses to be shared equally on a worldwide basis.

For the three and six months ended June 30, 2024, we recognized expenses, net of Merck's reimbursements, of $ million and $ million, respectively, related to the INT collaboration under the Merck Participation Term. For the three and six months ended June 30, 2023, these expenses were $ million and $ million, respectively.

Additionally, for the three and six months ended June 30, 2024, the net cost recovery for capital expenditures was $ million and $ million, respectively. For the three and six months ended June 30, 2023, the net cost recovery for capital expenditures was $ million and $ million, respectively. These amounts were applied to reduce the capitalized cost of the assets.

We have other collaborative and licensing arrangements that we do not consider to be individually significant to our business at this time. Pursuant to these agreements, we may be required to make upfront payments and payments upon achievement of various development, regulatory and commercial milestones, which in the aggregate could be significant. Future milestone payments, if any, will be reflected in our consolidated financial statements when the corresponding events have occurred. In addition, we may be required to pay significant royalties on future sales if products related to these arrangements are commercialized.

Development and Commercialization Funding Arrangement with Blackstone Life Sciences (Blackstone)

In March 2024, we entered into a development and commercialization funding arrangement with Blackstone, under which Blackstone has committed to providing up to $ million in funding to us. This funding supports the development of our investigational mRNA-based influenza vaccine. Contingent upon regulatory approval in the U.S. and only if the approval is dependent on data from the funded activities, Blackstone will be entitled to receive low single-digit percentage royalties and up to $ million in sales milestone payments. These payments are based on net sales of our future influenza and combination vaccines, with sales milestone payments contingent upon achieving specified cumulative net sales targets.


15
Table of Contents
 $ $ $ $ $ $ Available-for-sale:Certificates of deposit       U.S. treasury bills       U.S. treasury notes  ()    Corporate debt securities  ()    Government debt securities  ()    Total$ $ $()$ $ $ $ December 31, 2023Amortized
CostUnrealized
GainsUnrealized
LossesEstimated Fair ValueCash and
Cash
EquivalentsCurrent
Marketable
SecuritiesNon-
Current
Marketable
SecuritiesCash and cash equivalents$ $ $ $ $ $ $ Available-for-sale:Certificates of deposit       U.S. treasury bills       U.S. treasury notes  ()    Corporate debt securities  ()    Government debt securities  ()    Total$ $ $()$ $ $ $ 

 $ Due after one year through five years  Total$ $ 

December 31, 2023
Amortized
Cost		Estimated
Fair Value
Due in one year or less$ $ 
Due after one year through five years  
Total$ $ 

In accordance with our investment policy, we place investments in investment grade securities with high credit quality issuers, and generally limit the amount of credit exposure to any one issuer. We evaluate securities for impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation.
16
Table of Contents
t recognize any impairment charges related to available-for-sale securities for the three and six months ended June 30, 2024 and 2023. We did t record any credit-related allowance for available-for-sale securities as of June 30, 2024 and December 31, 2023.

 $ $ $ $ $ U.S. treasury notes() () () Corporate debt securities() () () Government debt securities  () () Total$()$ $()$ $()$ 
As of December 31, 2023:

Accounts receivable, net$ $ 

Prepaid Expenses and Other Current Assets

 $ 
Down payments and prepayments related to manufacturing and materials
  Income tax receivable  Collaboration receivable  Interest receivable  Value added tax receivable  
Prepaid income tax
  Other current assets  Prepaid expenses and other current assets$ $ 

20
Table of Contents
 $ 
Inventory, non-current(1)
  
Goodwill
  
Finite-lived intangible asset
  Equity investments  Other  Other non-current assets$ $ 
_______

Accrued Liabilities

 $ Compensation-related  Manufacturing  Other external goods and services  Clinical trials  Property, plant and equipment  Development operations  Raw materials  
Commercial
  Royalties  
Loss on future firm purchase commitments(1)
  Accrued liabilities$ $ 
______
(1)Related to losses that are expected to arise from firm, non-cancellable, commitments for future raw material purchases (Note 7).

Other Current Liabilities

 $ Other  Other current liabilities$ $ 
21
Table of Contents

 $ $()$ Grant revenue    Collaboration revenue  () 
Licensing and royalty revenue
    Total deferred revenue$ $ $()$ 

main campuses in Massachusetts, our Cambridge campus and our Moderna Technology Center (MTC), an industrial technology center located in Norwood. We also lease various parcels of land, and office and lab spaces across the globe for our business operations.

Cambridge Campus

Our Cambridge campus consists of multiple leased properties, including office and research laboratory spaces totaling approximately  square feet, including the Moderna Science Center.

Moderna Science Center

In September 2021, we entered into a lease agreement for a building in Cambridge, Massachusetts, comprising approximately square feet. This facility, which includes our principal executive offices along with additional office and laboratory spaces, is referred to as the Moderna Science Center (MSC). After an approximately building project, the lease term is years, with options for additional extensions. During the third quarter of 2023, we commenced the lease and recognized the related right-of-use asset and lease liability on our condensed consolidated balance sheets.

Following the commencement of the MSC lease, we amended the expiration dates of our existing leases at Technology Square in the fourth quarter of 2023. Originally scheduled to expire ranging from 2024 to 2029, these leases have been adjusted to conclude by early 2025. All our Cambridge leases are classified as operating leases.

Moderna Technology Center

Our Moderna Technology Center is composed of buildings, MTC South, MTC North and MTC East, totaling approximately square feet. Our MTC leases expire in 2042 and we have the option to extend the term for extension periods of each. All of our MTC leases are classified as finance leases.

22
Table of Contents
 $ 
Right-of-use assets, financing, net(3) (4)
  Total$ $ Liabilities:Current:
Operating lease liabilities(5)
$ $ 
______
(1)Includes certain optional lease term extensions, predominantly related to the MTC leases, which represent a total of $ million of undiscounted future lease payments.


23
Table of Contents
t experienced any material losses related to these indemnification obligations, and material claims were outstanding. We do not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and related reserves were established.

Purchase Commitments and Purchase Orders

We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services. As of June 30, 2024, we had $ billion of non-cancelable purchase commitments related to raw materials and manufacturing agreements, which are expected to be paid through 2029. As of June 30, 2024, we had $ million of non-cancelable purchase commitments related to clinical services and other goods and services which are expected to be paid through 2030. These amounts represent our minimum contractual obligations, including termination fees.

In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors. Certain agreements provide for termination rights subject to termination fees or winddown costs. Under such agreements, we are contractually obligated to make certain payments to vendors, mainly, to reimburse them for their unrecoverable outlays incurred prior to cancellation. As of June 30, 2024, we had cancelable open purchase orders of $ billion in total under such agreements for our significant clinical operations and support and contract manufacturing. These amounts represent only our estimate of those items for which we had a contractual commitment to pay as of June 30, 2024, assuming we would not cancel these agreements. The actual amounts we pay in the future to the vendors under such agreements may differ from the purchase order amounts.

Licenses to Patented Technology

We have patent license agreements with Cellscript, LLC and its affiliate, mRNA RiboTherapeutics, Inc., and the National Institute of Allergy and Infectious Diseases. Under these agreements, we are required to pay royalties and certain milestone payments. For further information on our licensing and royalty payments, please refer to our 2023 Form 10-K under the heading “Business—Intellectual Property—In-licensed intellectual property” and Note 11 to our consolidated financial statements contained therein.

For the three and six months ended June 30, 2024, we recognized $ million and $ million, respectively, of royalty expenses associated with our product sales. For the three and six months ended June 30, 2023, we recognized $ million and $ million, respectively, of royalty expenses associated with our product sales. These royalty expenses were recorded to cost of sales in our condensed consolidated statements of operations.

Additionally, we have other in-license agreements with third parties which require us to make future development, regulatory and commercial milestone payments and sales-based royalties for specified products associated with the agreements. The achievement of these milestones have not yet occurred as of June 30, 2024.

24
Table of Contents
 $ $ $ 
Restricted Stock Units (RSUs) and Performance Stock Units (PSUs)
    Employee Stock Purchase Plan (ESPP)    
Total
$ $ $ $ Cost of sales$ $ $ $ Research and development    Selling, general and administrative    
Total
$ $ $ $ 

As of June 30, 2024, there was $ billion of total unrecognized compensation cost related to unvested stock-based compensation with respect to options, RSUs and PSUs granted. That cost is expected to be recognized over a weighted-average period of years as of June 30, 2024.

Share Repurchase Programs

As of June 30, 2024, $ billion of our Board of Directors’ authorization for repurchases of our common stock (the 2022 Repurchase Programs) remains outstanding, with no expiration date. The timing and actual number of shares repurchased under the 2022 Repurchase Programs will depend on a variety of factors, including price, general business and market conditions, and other investment opportunities, and shares may be repurchased through open market purchases through the use of trading plans intended to qualify under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended.

shares repurchased.

)$()$()$()Provision for (benefit from) income taxes$ $()$ $()Effective tax rate % %()% %

The effective tax rate for the three and six months ended June 30, 2024 was higher than the statutory rate, due to certain of our foreign subsidiaries that have taxable income, while we incurred a net loss before income taxes on a consolidated basis. We cannot recognize tax benefits from the loss due to our global valuation allowance, which we continue to maintain against the majority of our global deferred tax assets. The changes in our effective tax rate, compared to the same periods in 2023, primarily result from the continued application of our valuation allowance and adjustments of our valuation allowance, which was initially established in the third quarter of 2023. For additional details regarding our deferred tax assets and the policies governing our valuation allowance, please refer to Note 13 to our consolidated financial statements in our 2023 Form 10-K.
25
Table of Contents


)$()$()$()Denominator:
Basic and diluted weighted-average common shares outstanding
    
Basic and Diluted EPS
$()$()$()$()
Common stock equivalents excluded from the EPS computation above because their inclusion would have been anti-dilutive
    

26
Table of Contents
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited financial information and related notes included in this Form 10-Q and our consolidated financial statements and related notes and other financial information in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission (the SEC) on February 23, 2024 (the 2023 Form 10-K).

Overview

We are a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases, independently and with our strategic collaborators.

Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. We have a diverse and extensive development pipeline of 40 development candidates across our 47 development programs, of which 43 are in clinical studies currently.

Our COVID-19 vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®. Our original vaccine, mRNA-1273, targeted the SARS-CoV-2 ancestral strain, and we have leveraged our mRNA platform to rapidly adapt our vaccine to emerging SARS-CoV-2 strains to provide protection as the virus evolves and regulatory guidance is updated. In May 2024, the U.S. Food and Drug Administration (FDA) granted approval for mRESVIA® (mRNA-1345), our mRNA vaccine against respiratory syncytial virus (RSV), to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection. This marks our second approved mRNA product and underscores our ongoing commitment to delivering solutions for patients by addressing global public health threats related to infectious diseases.

Business Highlights

RSV

In May 2024, the FDA approved mRESVIA to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks our second approved mRNA product. Subsequently, the Advisory Committee on Immunization Practices (ACIP) issued a recommendation for all unvaccinated people 75 years of age and older and unvaccinated people ages 60-74 who are at increased risk for RSV to receive the vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD).

In June 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for mRESVIA in the European Union. We have filed for mRNA-1345 approval with regulators in multiple markets around the world.
27
Table of Contents

The FDA’s approval of mRESVIA was based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found mRNA-1345 had a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). A follow-up analysis of the primary endpoint was performed during FDA review, including cases that started before the primary analysis cut-off date but were not confirmed until afterward. The results were consistent with the primary analysis [VE 78.7% (CI 62.9%, 87.8%)] and were included in the U.S. package insert. An additional longer-term analysis showed mRNA-1345 had continued protection against RSV LRTD over 8.6 months median follow-up.

COVID-19

Consistent with guidance from regulators, we have updated our COVID-19 vaccine to target the KP.2 and JN.1 strains of the SARS-CoV-2 virus, and are prepared to meet the anticipated 2024-2025 season demand. We anticipate supplying our vaccine targeting the KP.2 strain to the U.S. and Canadian markets, consistent with guidance from U.S. and Canadian regulators, respectively. Our vaccine targeting the JN.1 strain will be available to support other markets where regulators are targeting JN.1, subject to regulatory approvals. We have submitted data to regulators worldwide to support registration and supply of the Spikevax 2024-2025 formula in time for the upcoming vaccination season, which will commence in the third quarter.


Pandemic influenza

In June 2024, we were awarded up to $176 million through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines. The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The project award will support the late-stage development of an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against the H5 influenza virus. This subtype of the influenza virus causes a highly infectious and severe disease in birds known as avian influenza and poses a risk of spillover into the human population. The agreement also includes additional options to prepare for and accelerate responses to future public health threats.

In 2023, we initiated a Phase 1/2 study to generate safety and immunogenicity data for our investigational pandemic influenza vaccine (mRNA-1018) in healthy adults aged 18 years and older. The study includes vaccine candidates against the H5 and H7 avian influenza viruses.

Japan

In July 2024, we entered into a joint agreement with Mitsubishi Tanabe Pharma Corporation regarding the co-promotion of our mRNA respiratory vaccine portfolio in Japan, including Spikevax. Under the agreement, we will handle the manufacturing, sales, medical education and distribution of our mRNA respiratory vaccines. Both companies will engage in activities to enable broad access to our mRNA respiratory portfolio to have the maximum impact on public health in Japan.

In April 2024, we entered a non-exclusive out-licensing agreement with a pharmaceutical company based in Japan for mRNA COVID-19-related intellectual property for the territory of Japan. We received an upfront payment of $50 million, which included a $20 million prepayment creditable against future royalties. Additionally, we are entitled to low double-digit royalties on the net sales of the company’s COVID-19 product.

Net product sales and Net loss per share

For the second quarter of 2024, we recognized net product sales of $184 million from sales of our COVID-19 vaccine, compared to $293 million for the second quarter of 2023. Net loss per share was $(3.33) for the second quarter of 2024, compared to $(3.62) for the second quarter of 2023.

Recent Program Developments

Next-generation COVID-19 vaccine

•In June 2024, we announced that our next-generation COVID-19 vaccine candidate (mRNA-1283) met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax in participants 12 years of age and older. Higher efficacy was observed in adults 18 years of age and older compared to Spikevax (mRNA-1273), with a consistent trend observed in the subset of adults age 65 and older.

28
Table of Contents
Combination vaccine against influenza and COVID-19

•In June 2024, we announced that our combination vaccine candidate against influenza and COVID-19 (mRNA-1083) met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older. mRNA-1083 comprises components of mRNA-1010, our vaccine candidate for seasonal influenza, and mRNA-1283, our next-generation COVID-19 vaccine candidate. Each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results.

Individualized neoantigen therapy (INT)

•In June 2024, we and our collaborator, Merck, announced additional 3-year data showing that our investigational INT mRNA-4157 (V940) in combination with KEYTRUDA® demonstrated sustained improvement in recurrence-free survival and distant metastasis-free survival versus KEYTRUDA alone in patients with high-risk stage III/IV melanoma following complete resection. In the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, at a median planned follow-up of 34.9 months, the combination therapy reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to KEYTRUDA alone. The 2.5-year recurrence-free survival rate was 74.8% for the combination therapy versus 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups.

•We and Merck have initiated Phase 3 randomized clinical trials evaluating mRNA-4157 (V940) in combination with KEYTRUDA as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma and non-small cell lung cancer. Both trials are actively enrolling. In 2024, we and Merck also initiated three new randomized clinical studies in additional tumor types, including: a Phase 2 adjuvant treatment in patients with renal cell carcinoma, or kidney cancer; a Phase 2 adjuvant treatment in patients with high-risk muscle-invasive bladder cancer; and a Phase 2/3 neoadjuvant and adjuvant treatment in patients with cutaneous squamous cell carcinoma, the second most common form of skin cancer.

Rare Disease and Other Therapeutics

•Methylmalonic Acidemia (MMA): In June 2024, the FDA selected our investigational therapeutic for MMA (mRNA-3705) for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. The START pilot program was initiated by the FDA in September 2023 to accelerate the development of novel treatments addressing unmet medical needs in rare diseases, with an initial selection of up to seven novel treatments, three by the Center for Drug Evaluation and Research (CDER) and four by the Center for Biologics Evaluation and Research (CBER). The milestone-driven initiative is intended to help the progression to pivotal clinical studies or pre-BLA/NDA meeting stages by enhancing communications between manufacturers and the FDA. Selected manufacturers are expected to benefit from rapid, ad hoc FDA interactions to support clinical development, such as study design, patient population, and statistical methods, beyond standard formal meetings. The program is designed to generate high-quality, reliable data to support marketing approvals, ensuring promising treatments advance efficiently through regulatory milestones.


29
Table of Contents
Our Pipeline

The following chart shows our current pipeline of 47 development programs across our six modalities.
SEC FIling - Full pipeline chart - 2Q24_072424.jpg
Abbreviations: BARDA, Biomedical Advanced Research and Development Authority; CMV, cytomegalovirus; cSCC, cutaneous squamous cell carcinoma; EBV, Epstein-Barr virus; HCoV, human coronaviruses; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; HSV, herpes simplex virus; IAVI, International AIDS Vaccine Initiative; ILCM, Institute for Life Changing Medicines; IL-23, interleukin 23; IL-36γ, interleukin-36 gamma; IM, infectious mononucleosis; NIH, National Institutes of Health; NSCLC, non-small cell lung cancer; OX40L, wildtype OX40 ligand; RCC, renal cell carcinoma; RSV, respiratory syncytial virus; VZV, varicella-zoster virus.

30
Table of Contents
Results of operations

The following table summarizes our condensed consolidated statements of operations for the periods presented (in millions):
Three Months Ended June 30,
Change 2024 vs. 2023
20242023$%
Revenue:
Net product sales$184 $293 $(109)(37)%
Other revenue57 51 6 12%
Total revenue241 344 (103)(30)%
Operating expenses:
Cost of sales115 731 (616)(84)%
Research and development1,221 1,148 73 6%
Selling, general and administrative268 332 (64)(19)%
Total operating expenses1,604 2,211 (607)(27)%
Loss from operations(1,363)(1,867)504 (27)%
Interest income111 104 7 7%
Other (expense) income, net(27)14 (41)293%
Loss before income taxes(1,279)(1,749)470 (27)%
Provision for (benefit from) income taxes— (369)369 (100)%
Net loss$(1,279)$(1,380)$101 (7)%
Six Months Ended June 30,
Change 2024 vs. 2023
20242023$%
Revenue:
Net product sales$351 $2,121 $(1,770)(83)%
Other revenue57 85 (28)(33)%
+

The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
40
Table of Contents

SIGNATURES
Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
                                
MODERNA, INC.
Date:By:/s/ Stéphane Bancel
August 1, 2024
Stéphane Bancel
Chief Executive Officer and Director
(Principal Executive Officer)
Date:By:/s/ James M. Mock
August 1, 2024
James M. Mock
Chief Financial Officer
(Principal Financial Officer)

41

Similar companies

See also AMGEN INC - Annual report 2024 (10-K 2024-12-31) Annual report 2025 (10-Q 2025-03-31)
See also GILEAD SCIENCES, INC. - Annual report 2022 (10-K 2022-12-31) Annual report 2023 (10-Q 2023-09-30)
See also BioNTech SE
See also BIOGEN INC. - Annual report 2023 (10-K 2023-12-31) Annual report 2025 (10-Q 2025-03-31)
See also Seagen Inc. - Annual report 2022 (10-K 2022-12-31) Annual report 2023 (10-Q 2023-09-30)