# EDGAR Filing Document

**Accession Number:** 0001682852
**File Stem:** 0001308179-23-000065
**Filing Date:** 2023-2
**Character Count:** 20610
**Document Hash:** 188251318efca9d9e0f2c66789427eb6
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001308179-23-000065.hdr.sgml**: 20230227

**ACCESSION NUMBER**: 0001308179-23-000065

**CONFORMED SUBMISSION TYPE**: ARS

**PUBLIC DOCUMENT COUNT**: 1

**CONFORMED PERIOD OF REPORT**: 20221231

**FILED AS OF DATE**: 20230227

**DATE AS OF CHANGE**: 20230227

**EFFECTIVENESS DATE**: 20230227

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Moderna, Inc.
- **CENTRAL INDEX KEY:** 0001682852
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 813467528
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** ARS
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38753
- **FILM NUMBER:** 23670094

**BUSINESS ADDRESS:**
- **STREET 1:** 200 TECHNOLOGY SQUARE
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02139
- **BUSINESS PHONE:** 6177146500

**MAIL ADDRESS:**
- **STREET 1:** 200 TECHNOLOGY SQUARE
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02139

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Moderna Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20160822

### Attached PDF Documents

**Attachment 1:** `lmrna2023_ars.pdf`

# 20
annual
report
22

moderna

# Moderna by the numbers

**2010**
founding year

**3,900+**
team members
worldwide
(up from 2,700 last year)

**Cambridge, MA**
headquarters

50%

**women** in
our workforce

41%

of executives
**are women**
(up from 39%
last year)

8

**years in a row**
as a *Science*
top employer

5

**Medical areas**
of focus

- Infectious Diseases
- Immuno-Oncology
- Rare Diseases

- Cardiovascular Diseases
- Autoimmune Diseases

Development programs
in active clinical trials

![img-0.jpeg](img-0.jpeg)

Development
programs

![img-1.jpeg](img-1.jpeg)

All figures as of December 31, 2022.

**17 locations** across North America, Europe and Asia Pacific where Moderna employees live and work

![img-2.jpeg](img-2.jpeg)

## Table of contents

**05** A letter from our CEO

**18** Pipeline

**24** Accelerating our progress

**25** Building our team

**27** Responsibility

**30** Leadership

**31** Awards and recognition

**32** Financials

moderna 2022 annual report | 03

# An update from our CEO

February 27, 2023

Since I shared my annual letter on January 3, the Moderna team has continued to make significant progress at speed. As we work to advance our new mission, I am pleased to provide a few updates.

## Progressing our RSV vaccine program

On January 17, we announced that our investigational mRNA vaccine targeting respiratory syncytial virus (RSV) met primary efficacy endpoints in our ConquerRSV Phase 3 trial. mRNA-1345 demonstrated vaccine efficacy of 83.7 percent against RSV lower respiratory tract disease, as defined by two or more symptoms in older adults. The data are encouraging, and we look forward to publishing the full data set and sharing the results at an upcoming infectious disease medical conference.

Further, mRNA-1345 was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in late January. This designation for mRNA-1345 further emphasizes the significant health impact of RSV in older adults and the high unmet need. We look forward to productive conversations with the FDA in the hopes of bringing our RSV vaccine candidate for older adults to the market safely and quickly.

Moderna's mRNA platform has now demonstrated two positive Phase 3 infectious disease trial results. We continue to advance a portfolio of respiratory mRNA vaccines targeting the most serious diseases.

## Investing in our platform

With our infectious disease franchise continuing to accelerate, and recent breakthroughs in the development of our personalized cancer vaccine, which was recently granted Breakthrough Therapy Designation by the U.S. FDA, as well as our rapid advancement in rare diseases and promising cardiology programs, the Moderna platform is delivering across several modalities. Our progress is meeting the high expectations we set out a few years ago, and we are accelerating our investments to deliver

the greatest possible impact to people through mRNA medicines. Our board has approved a significant increase to our R&D investments, with a budget for 2023 of around $4.5 billion, which is approximately 10x that of 2019. I cannot wait to see our pipeline two to three years from now.

## Acquiring OriCiro

In January, Moderna acquired Japan-based OriCiro Genomics for $85 million. With this acquisition, we obtain best-in-class tools for cell-free synthesis and amplification of plasmid DNA, a key building block in mRNA manufacturing. OriCiro's technology strategically complements our manufacturing expertise and further accelerates our research and development engine. We look forward to welcoming the OriCiro team to Moderna.

## Building our team

Since we started the new year, the Moderna team has grown to more than 4,000 people across 17 locations worldwide. We are rapidly expanding and investing in people and resources to scale our company, and we recently announced our intention to hire approximately 2,000 more team members by the end of 2023. By building out our technical development, manufacturing operations and digital teams in Massachusetts and beyond, we can produce more mRNA medicines quickly and at the highest quality to make an even bigger impact on human health.

2023 will continue to be a very exciting year for Moderna, and most importantly, for patients. I encourage you to read through the pages that follow and look forward to our continued journey together.

Cheers,

04 | moderna 2022 annual report

# A letter from our CEO

January 3, 2023

Cambridge, Mass., USA

![img-3.jpeg](img-3.jpeg)

> “Today, we have the technology, the resources, and the team to change medicine forever.”

Stéphane Bancel, Chief Executive Officer

## Dear fellow shareholders,

When the world was disrupted by a global pandemic, a new technology played a critical role in protecting and restoring human health. Bringing hope during a time of suffering. Bringing relief during a time of anxiety.

That technology was mRNA.

mRNA is a very special molecule in the body. It exists there, hundreds of thousands of mRNA molecules in each one of your cells. It can help prevent and fight disease.

While others are just recognizing the potential of injecting mRNA as a medicine, as the pioneers, we’ve been at this for more than a decade. Although it may be new to much of the world, the technology is already several generations into its existence to us.

Since the beginning, it has been our mission to deliver on the promise of mRNA technology for

patients. And we delivered at speed with our mRNA vaccine against COVID-19. As our first approved product, it has impacted hundreds of millions of lives around the world.

Today, we have the technology, the resources, and the team to change medicine forever. With 48 mRNA programs in our pipeline and 35 development candidates in active clinical trials, I believe this is just the beginning.

## 2022 was a Pivotal Year

In 2022, we matured to a company with multiple products on the market, and an extensive research pipeline across multiple modalities. Indeed, after 12 years of hard work on the science, we reached the most important pivot point in our company’s history.

moderna 2022 annual report | 05

A letter from our CEO

## “ Our platform technology also delivered the world’s first-ever mRNA cancer treatment to show efficacy in a randomized Phase 2 study.”

We delivered again in the fight against COVID with two authorized Omicron-targeting bivalent vaccines, mRNA-1273.214 and mRNA-1273.222, bringing the latter to market in less than two months. Today, our COVID-19 vaccines have been approved in more than 70 countries as we continue to build our respiratory franchise.

Our platform technology also delivered the world’s first-ever mRNA cancer treatment to show efficacy in a randomized Phase 2 study. By making an individualized medicine for each unique patient, we are pioneering a new frontier in the fight against cancer with cancer treatments. And in another important advancement this year, we are seeing early promise in two rare disease programs.

Additionally, with the announcement of our Global Public Health strategy in 2022, we expanded our portfolio with a commitment to develop vaccines against priority pathogens that threaten global health including HIV, tuberculosis, malaria and neglected tropical diseases. We will continue to transparently report on our progress in our ESG Report, the first of which published last June.

To support our accelerated growth and to further deliver on our mission, we have stood up operations in 17 countries and we are building manufacturing plants around the world. At the same time, we are entering into partnerships

with overseas governments, including a recently announced 10-year strategic partnership with the UK, to bring pandemic response capabilities as well as mRNA research, development and manufacturing to their broader health and science ecosystem.

We brought on new leaders in 2022 who will help us scale during our next phase of growth as we prepare for several upcoming new product launches. The Moderna team is now approximately 3,900 strong, all working together to positively impact human health globally.

Reflecting on our 2022 strategic priorities, we set out to advance our pan-respiratory booster vaccine; develop first-in-class vaccines against the most important latent viruses; bring to market therapeutics based on mRNA-encoded proteins; and bring to market innovative therapeutics based on mRNA-encoded gene editing enzymes. Our team has made important progress on these priorities to deliver on our mission for patients and create value for our shareholders, our employees, our communities and our partners.

Moderna is at an exciting stage with a growing mRNA platform, including three Phase 3 trials ongoing for new drugs, upcoming proof-of-concept data in rare diseases, significant commercial momentum and a strong financial position.

06 | moderna 2022 annual report

A letter from our CEO

![img-4.jpeg](img-4.jpeg)

moderna 2022 annual report | 07

A letter from our CEO

Looking ahead, we will continue to lead with our Values, our Mindsets and a deep sense of purpose embedded in everything we do. Our focus is to use our mRNA platform and the infrastructure we have built to address infectious and serious diseases. We will measure our success on the impact we make on improving human health.

## Evolving Our Mission

When we set out in 2010, our Mission was “to deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.” Just as our company evolves in this new age of medicine, so too must our mission.

Moderna has delivered on the promise of mRNA science.

Our team is using this knowledge to bring new drugs to the clinic and our platform is coming to life with multiple investigational drugs within modalities. Now we possess the necessary data, experience and expertise needed to quickly develop innovative medicines that continue to perpetually deliver on the promise of mRNA science.

With this, we can continue to build Moderna into the company we want it to be. We are harnessing the power of mRNA to create a new category of medicines and a company that maximizes its impact on human health.

Our new Mission: Deliver the greatest possible impact to people through mRNA medicines.

## Delivering the Greatest Possible Impact through mRNA Medicines

Now that we know our mRNA medicines can have a profound impact on human health, we will continue to focus on relentless execution of our goals. I will share a few highlights of our recent progress and anticipated milestones in this letter and you can learn more from our September 2022 R&D Day announcement.

## Respiratory Vaccines

As we build our respiratory franchise, we are applying our experience and using our mRNA platform to develop medicines that can help prevent hospitalizations and deaths from the top respiratory viruses. By pursuing combination products to protect against a range of diseases, we can potentially help decrease morbidity and mortality from respiratory disease, lower healthcare costs and increase health security globally.

Our late-stage respiratory vaccine pipeline continues to progress. The Phase 3 immunogenicity and safety study of one of our seasonal influenza vaccine candidates in the Southern Hemisphere is fully enrolled with approximately 6,000 participants. We also initiated a Phase 3 efficacy trial in the Northern Hemisphere to test the vaccine’s efficacy compared to a currently licensed seasonal influenza vaccine.

08 | moderna 2022 annual report

A letter from our CEO

# Our Mission: Deliver the greatest possible impact to people through mRNA medicines.

moderna 2022 annual report | 09

A letter from our CEO

# “ We are excited to develop novel mRNA medicines to address the significant unmet medical needs of heart failure patients, joining our existing clinical candidates in infectious diseases, oncology and rare diseases.”

The Phase 3 study of our RSV vaccine candidate in adults over 60 years of age has enrolled more than 36,000 of the 37,000-participant target. The study has been designed to provide an efficacy readout expected in the 2023 winter season. Since RSV also imposes a significant disease burden on children, we are studying our RSV vaccine candidate in an ongoing Phase 1 trial in pediatric populations.

We are also progressing several combination respiratory vaccine candidates. A Phase 1/2 study of our combination vaccine candidate targeting SARS-CoV-2 and influenza is fully enrolled and ongoing. We further initiated a clinical trial for a combination vaccine candidate targeting SARS-CoV-2, influenza, and RSV this year.

### Latent Vaccines

Once a human is infected by a latent virus, the virus remains in the body and can lead to lifelong medical complications. We are committed to developing a portfolio of vaccine and therapeutic candidates against latent viruses, including cytomegalovirus (CMV), Epstein-Barr virus (EBV), human immunodeficiency virus (HIV) and varicella-zoster virus (VZV). To date, we have enrolled approximately 40 percent of anticipated

participants in the Phase 3 study of our CMV vaccine candidate and enrollment is ongoing in the U.S. and internationally.

### Public Health Vaccines

We have also focused on developing a global health vaccine program since our inception and with our recently announced Global Public Health Strategy, we are expanding our work to develop vaccines against 15 priority pathogens that threaten global health by 2025. We are committed to bringing the full force of our mRNA vaccine platform to combat infectious diseases of public health concern and we look forward to working with global partners to prevent future pandemics and help millions of people worldwide.

### Therapeutics

#### Cancer

Personalized cancer vaccines target an individual patient's unique tumor mutations to selectively treat their cancer. Moderna's personalized cancer vaccine program is being developed in partnership with Merck and is designed to stimulate an immune response by boosting T cells, which are believed to be necessary for recurrence-free survival.

10 | moderna 2022 annual report

Table of Content

* Filed herewith.

† Pursuant to 17 C.F.R. §§230.406 and 230.83, the confidential portions of this exhibit have been omitted and are marked accordingly.

# Indicates a management contract or any compensatory plan, contract or arrangement.

+ The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certifications 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.

(1) Incorporated by reference to the Registration Statement on Form S-1 (File No. 333-228300) filed with the Securities and Exchange Commission on November 9, 2018.
(2) Incorporated by reference to the Current Report on Form 8-K (File No. 001-38753) filed with the Securities and Exchange Commission on December 14, 2018.
(3) Incorporated by reference to the Quarterly Report on Form 10-Q (File No. 001-38753) filed with the Securities and Exchange Commission on November 6, 2019.
(4) Incorporated by reference to the Quarterly Report on Form 10-Q (File No. 001-38753) filed with the Securities and Exchange Commission on May 6, 2021.
(5) Incorporated by reference to the Quarterly Report on Form 10-Q (File No. 001-38753) filed with the Securities and Exchange Commission on October 30, 2020.
(6) Incorporated by reference to the Annual Report on Form 10-K (File No. 001-38752) filed with the Securities and Exchange Commission on February 27, 2020.
(7) Incorporated by reference to the Annual Report on Form 10-K (File No. 001-38752) filed with the Securities and Exchange Commission on February 25, 2022.
(8) Incorporated by reference to the Current Report on Form 8-K/A (File No. 001-38753) filed with the Securities and Exchange Commission on May 13, 2022.
(9) Incorporated by reference to the Current Report on Form 8-K/A (File No. 001-38753) filed with the Securities and Exchange Commission on June 1, 2022.
(10) Incorporated by reference to the Quarterly Report on Form 10-Q (File No. 001-38753) filed with the Securities and Exchange Commission on November 3, 2022.

157

Table of Content

# **Item 16. Form 10-K Summary**

Not applicable.

158

Table of Content

# **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:
February 24, 2023

By: /s/ Stéphane Bancel

Stéphane Bancel
Chief Executive Officer and Director

159

Table of Content

# **POWER OF ATTORNEY AND SIGNATURES**

Each individual whose signature appears below hereby constitutes and appoints each of Stéphane Bancel and James M. Mock as such person’s true and lawful attorney-in-fact and agent with full power of substitution and resubstitution, for such person in such person’s name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that any said attorney-in-fact and agent, or any substitute or substitutes of any of them, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

| Signature | Title | Date |
| --- | --- | --- |
| /s/ Stéphane Bancel Stéphane Bancel | Chief Executive Officer and Director (Principal Executive Officer) | February 24, 2023 |
| /s/ James M. Mock James M. Mock | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) | February 24, 2023 |
| /s/ Noubar B. Afeyan, Ph.D. Noubar B. Afeyan, Ph.D. | Chairman and Director | February 24, 2023 |
| /s/ Stephen Berenson Stephen Berenson | Director | February 24, 2023 |
| /s/ Sandra Horning, M.D. Sandra Horning M.D. | Director | February 24, 2023 |
| /s/ Robert Langer, Sc.D. Robert Langer, Sc.D. | Director | February 24, 2023 |
| /s/ Francois Nader, M.D. Francois Nader M.D. | Director | February 24, 2023 |
| /s/ Elizabeth Nabel, M.D. Elizabeth Nabel, M.D. | Director | February 24, 2023 |
| /s/ Paul Sagan Paul Sagan | Director | February 24, 2023 |
| /s/ Elizabeth Tallett Elizabeth Tallett | Director | February 24, 2023 |

160

![img-0.jpeg](img-0.jpeg)

**Corporate headquarters**

200 Technology Square, Cambridge, MA 02139
phone 617 714 6500 | fax 617 583 1998

modernatx.com

**Transfer Agent:**

Computershare Trust Company, N.A.

**Audit Firm:**

Ernst & Young, LLP