annual
report
2023
Table of
Contents
A letter from
our CEO
Advancing mRNA
respiratory vaccines
A new frontier
in cancer care
Pipeline
Building
our team
Digitizing
everywhere
Responsibility
Leadership Awards and
recognition
Financials
by
the numbers
In 2023,
we impacted more than
100 million
people.
moderna 2023 annual report
02
Delivering commercial impact
$6.7B
48%
in net product
sales in 2023
U.S. COVID retail
market share
in fall 2023
$13.3B
in cash, cash equivalents
and investments as
of December 31, 2023
Advancing our pipeline
45
4
therapeutic
areas
development
programs
9
late-stage
programs
Creating a unique and diverse organization
5,600
49%
39%
employees
in 19 markets
women in
our workforce
of executives
are women
Celebrating our culture
2nd
9
consecutive year of equal
pay for equal work study
showing no significant
differences in pay
years in a row
as a Science
top employer
No. 1
ranked large
company in
BioSpace Best
Places to Work
03
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Table of
Contents
A letter from
our CEO
Advancing mRNA
respiratory vaccines
A new frontier
in cancer care
Pipeline
Building
our team
Digitizing
everywhere
Responsibility
Leadership Awards and
recognition
Financials
Table of contents
05 A letter from our CEO
22 Digitizing everywhere
14 Advancing mRNA
respiratory vaccines
15 A new frontier
in cancer care
17 Pipeline
20 Building our team
23 Responsibility
26 Leadership
27 Awards and recognition
28 Financials
moderna 2023 annual report
04
A letter from our CEO
January 2, 2024
Cambridge, Mass., U.S.A.
“
As we reflect on the past year, our commitment
to leveraging mRNA to deliver transformative
medicines for patients has never been stronger. ”
Stéphane Bancel,
Chief Executive Officer
Dear fellow shareholders,
Our mRNA platform is working.
Today, we are seeing the high-case scenario from our 2018 five-year, long-
range plan unfold. We have demonstrated the potential for clinical benefit in
multiple infectious disease vaccines, in skin cancer and in three different rare
genetic diseases. Based on these clinical successes, we have advanced a
broad and diverse pipeline.
Now, it is up to us to bring these mRNA medicines to market for patients, and
consequently to drive value for our shareholders.
As we reflect on the past year, our commitment to leveraging mRNA to deliver
transformative medicines for patients has never been stronger. We have
the platform, technology, resources and the team to establish a new era of
We advanced nine programs into late-stage development, including one
approved, one filed for approval, and three more that have completed Phase 3
enrollment. We are many steps closer to reaching millions more people with
unmet medical needs.
medicine.
A Year of Transition
Through more than a decade of progress and investment in science, Moderna
has led in establishing the field of mRNA medicine. The team has built a
remarkable platform to scale Moderna at a pace not seen before in our industry.
In 2023, SARS-CoV-2 continued to evolve. The virus that causes COVID-19 is
clearly here to stay—just like influenza. Our business has also adapted to a more
predictable, seasonal endemic market.
05
A letter from our CEO
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Managing the transition took significant effort in 2023. As you know, we rapidly
Additionally, we announced a strategic partnership with the Coalition for
scaled our manufacturing capabilities during the pandemic to play a critical role
Epidemic Preparedness Innovations (CEPI), harnessing the power and speed of
in combatting COVID-19 with our vaccine. We knew that this surge capacity
Moderna's mRNA platform to accelerate the development of mRNA vaccines
may not be required in the endemic market, but we felt obligated to ensure we
against viral disease outbreaks that pose global public health threats. The
protected as many lives as we could during the pandemic.
expansion of our mRNA Access program reinforces our dedication to public
During 2023, it became clear that demand for vaccines had entered a new
stage of the endemic setting and we pivoted to significantly resize our
manufacturing infrastructure to help ensure our COVID-19 franchise would be
profitable in 2024 and beyond. Although undervaccination has been observed in
health by providing researchers with our mRNA technology in the development
of vaccines for emerging and neglected infectious diseases. We believe this
program can play a key role in helping the next generation of researchers and
engineers to advance mRNA science.
the first endemic season, we believe this will settle out over the coming years as
We also announced the acquisition of Japan-based OriCiro Genomics, which
the impact of the virus and vaccine during endemic periods becomes evident
we now have integrated into Moderna as Moderna Enzymatics. That technology
and may affect future levels of vaccination.
At the same time, we invested in our people, processes, and digital systems
to help us build Moderna for the long term. We opened a technology
hub in Seattle and welcomed Brad Miller as Chief Information Officer,
emphasizing our continued focus on building digital-first and investing in
AI because of the profound impact it will have on our Mission. To further
advance our mRNA science, we also entered into a partnership with IBM to
explore quantum computing and generative AI. We believe that AI will be as
transformational to any business as the desktop computer was when it entered
the corporate world.
will enable us to reduce manufacturing cycle times and improve quality. We also
established strategic collaborations with CytomX, Generation Bio, Immatics and
Life Edit, to enhance our internal research and development.
06
A letter from our CEO
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Delivering the Greatest Possible Impact
Last year, we provided external guidance for Spikevax sales of at least $6 billion. We continued to focus on public health efforts to increase vaccination rates globally,
and in the U.S. we achieved 48 percent market share for the 2023 fall season, compared to 37 percent in fall 2022—demonstrating our ability to compete in the
commercial market. Recognizing that COVID is not going away, we are making it an important piece of our business with our vaccines against COVID-19 and our
investigational combination vaccine against flu and COVID.
Spikevax U.S. Retail Administrations Market Share (%)
51
52
53
53
53
51
52
51
50
48
49
47
37
48
44
37
37
38
39
39
38
39
39
39
38
36
37
36
2023
2022
39
35
42
29
32
27
9/15
9/22
9/29
10/6
10/13 10/20 10/27
11/3
11/10
11/17
11/24
12/1
12/8
12/15
12/22
12/29
Source : Based on information licenced from IQVIA: IQVIA RAPID Weekly Audit for September-December 2022 and September-December 2023, reflecting estimates of
real-word activity. 2022 figures have been aligned to closest corresponding 2023 figures, based on weeks following approval/launch. All rights reserved.
Cumulative
percentage
(season to date)
In parallel, we prepared for the potential 2024 launch of our investigational RSV
on clinical trial data and ready-to-use pre-filled syringes when compared to two
vaccine for adults, which is expected to further strengthen our financial position
recently launched products. In addition, the mRNA vaccine technology that our
and further demonstrate the commercial potential of our mRNA platform. We
believe our RSV vaccine candidate has a potentially best-in-class profile based
RSV vaccine uses has a well-established safety and tolerability profile, having
been used in more than a billion COVID-19 vaccine doses.
07
A letter from our CEO
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Table of
Contents
A letter from
our CEO
Advancing mRNA
respiratory vaccines
A new frontier
in cancer care
Pipeline
Building
our team
Digitizing
everywhere
Responsibility
Leadership Awards and
recognition
Financials
“
We have an exciting late-stage
pipeline, and we expect to double
the number of programs in Phase 3
by 2025 and launch up to 15 products
in five years. ”
moderna 2023 annual report
08
A letter from our CEO
Turning to the rest of our pipeline, positive clinical trial results across cancer, rare disease and infectious disease were shared during our annual R&D Day in September,
when we announced our intent to launch up to 15 products in five years.
I will highlight a few notable 2023 milestones from across our 45 development programs.
The image above depicts Moderna’s pipeline as a cell map, reflecting the new development candidates, Lyme, Mpox and Norovirus, added in 2023 to Moderna’s infectious disease vaccines modality.
Respiratory Franchise
In 2023, we advanced our COVID, RSV and flu respiratory disease programs to
positive Phase 3 data. We received U.S. FDA approval of our updated COVID-19
vaccine and filed a Biologics License Application (BLA) for our RSV vaccine.
Additionally, our seasonal flu vaccine candidate met its primary endpoint in a
Phase 3 trial, and consultations with regulators on a potential licensing package
are ongoing.
Our combination vaccine candidates, which can also provide substantial public
health benefits, address respiratory viruses associated with the largest disease
burden in the category and are designed for higher compliance, increased
uptake, consumer convenience and benefits to healthcare systems. Enrollment
was completed in our combination trials for flu/COVID-19 (Phase 1/2), flu/RSV
(Phase 1), and flu/COVID-19/ RSV (Phase 1). We also recently initiated a Phase 3
trial of our combination vaccine against seasonal flu and COVID-19 with the
intention to have a combination vaccine available as early as 2025.
09
A letter from our CEO
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO “
We were excited to see such a robust clinical benefit
with our mRNA therapy, and to launch a new Phase 3 trial
with non-small cell lung cancer patients in December. ”
Latent Franchise
We continued to develop vaccines against six latent and other viruses with
unmet or underserved needs, including cytomegalovirus (CMV), Epstein-Barr
virus, herpes simplex virus, varicella zoster virus, norovirus and HIV. The pivotal
Phase 3 study, CMVictory, of our CMV vaccine candidate fully enrolled with
adults to evaluate the efficacy, safety and immunogenicity of the vaccine in the
prevention of primary infection in women of childbearing age. The Phase 3 study
is event-based but given the number of cases we have already seen, we could
have CMV Phase 3 data in 2024. CMV is the most common infectious cause
of birth defects in the U.S. and CMV has been designated a top priority in new
vaccine development by the U.S. National Academy of Medicine for more than
two decades.
Oncology Franchise
In 2023, we reported additional data from our Phase 2b trial evaluating our
individualized neoantigen therapy (INT) in combination with Merck’s KEYTRUDA®
in melanoma patients compared to KEYTRUDA alone. The treatment continued
to show significant and clinically meaningful improvement in recurrence-free
survival and reduced the risk of recurrence or death by 49 percent. These data,
with a median follow-up of approximately three years, demonstrate the durability
of the therapy.
We were excited to see such a robust clinical benefit with our mRNA therapy,
and to launch a new Phase 3 trial with non-small cell lung cancer patients
in December. To support this continued progress, we have been investing in
building a factory in Marlborough, Massachusetts, and in building out our people
capability, which will enable the commercial launch for INT.
Rare Disease Franchise
Our rare disease portfolio, which includes therapies targeting methylmalonic
acidemia (MMA), propionic acidemia (PA), glycogen storage disease and
Phenylketonuria, continued to show promise. The Phase 1/2 trial for our
MMA therapy candidate has dosed 11 participants with a total of 221 doses
administered and all participants have opted into the Open-Label Extension
study. A global Phase 1/2 trial for our PA candidate, which is our most advanced
rare disease program, is enrolling patients in the dose confirmation arm, and
most patients who have completed the treatment period of the main study have
opted to enter a long-term extension study.
10
A letter from our CEO
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Table of
Contents
A letter from
our CEO
Advancing mRNA
respiratory vaccines
A new frontier
in cancer care
Pipeline
Building
our team
Digitizing
everywhere
Responsibility
Leadership Awards and
recognition
Financials
“
Staying true to our Mission, we will
also continue to invest in science to
expand the field of mRNA medicine
into new frontiers. ”
moderna 2023 annual report
11
A letter from our CEO
Focusing on Execution
Acting Responsibly
As you can see, we have built significant momentum across our business and
Our commitment to corporate social responsibility remains strong, as evidenced
our pipeline. Across our respiratory, latent, oncology and rare franchises, we are
by the publication of our second annual ESG Report in June. As a company,
aiming to launch up to 15 new products over the next five years. We are excited
we care deeply about our patients, our employees, the environment and
by the near future and focused on execution to deliver for patients.
our communities, and we recognize that we have an opportunity to change
Staying true to our Mission, we will also continue to invest in science to expand
the field of mRNA medicine into new frontiers. For example, in partnership with
Vertex, we are advancing an investigational inhaled mRNA therapy in the lung
medicine for all. We will continue to engage, listen and understand what our
stakeholders expect from us as a sustainable, responsible business and leader
in mRNA medicines.
to treat the underlying cause of cystic fibrosis, which we expect to read out
This leadership is made possible by our people, who are the driving force behind
in 2024.
Over the same five-year period, we expect to advance many new candidate
medicines into clinical trials across established and new modalities. To do this,
we will continue to lead with our Values, our Mindsets and a deep sense of
purpose in everything we do.
our progress and our culture. I am proud of our team and award-winning culture,
which earned Moderna recognition from Science as a top employer for the ninth
consecutive year, from BioSpace as the #1 large employer in its Best Places to
Work report for the third year in a row, and from the Human Rights Campaign
Foundation as an Equality 100 company for the first time in 2023.
Download our 2022 ESG Report
12
A letter from our CEO
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO “
This leadership is made possible by our people, who are
the driving force behind our progress and our culture. ”
Looking Ahead
With these priorities, we are completing our strategy to accelerate the growth
of our business, a journey we have been on since mid-2021. We expect to break
Our focus for 2024 and 2025 is to drive sales growth and profitability. To achieve
even in 2026, as revenue grows and late-stage R&D costs recede, when the
that, we are focusing on three priorities.
current large Phase 3 clinical trials wind down and result in many potential new
Priority one is commercial execution. Our recent market share gain in the U.S.
product launches.
demonstrates that we can compete with large established players. We expect
Along the way, we will continue to invest in our people—the changemakers
COVID sales to stabilize in a fully endemic market, and we will build on our
who help us maximize our impact on human health. I am so grateful for their
current momentum to grow our market share for Spikevax in 2024.
dedication to our Mission and their relentless work. I am also thankful to all
To support this, we made the decision at the end of 2023 to flatten our
commercial organization to help us accelerate decisions and increase customer
understanding as we prepare for multiple product launches. With the expected
the people and organizations that partner with us on this journey to advance
our Mission to deliver the greatest possible impact to people through mRNA
medicines.
launch of our RSV vaccine candidate in 2024, and potential launch of our flu/
Thank you all for your ongoing trust and support as we work to deliver value to
COVID combination vaccine as early as 2025,
we believe Moderna will experience sales growth in 2025.
all our stakeholders, and bring mRNA medicines to the world.
We are excited about 2024. This is just the beginning…
Priority two is disciplined investment. We will continue to review our
manufacturing costs, product pipeline, and deliver efficiencies. Our upcoming
respiratory product launches in 2024 and 2025 will also achieve efficiencies from
Warmest regards,
a growing pipeline.
Priority three is executing on our late-stage pipeline to drive organic sales
growth. We have an exciting late-stage pipeline, and we expect to double the
number of programs in Phase 3 by 2025 and launch up to 15 products in five
years. Up to four of those launches could come by 2025.
Stéphane Bancel
Chief Executive Officer
13
A letter from our CEO
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Advancing mRNA respiratory vaccines
Follow-up data from a Phase 3 RSV study with a median follow-up duration of
8.6 months, with a range of 15 days to 530 days, and including subjects from the
Northern and Southern Hemispheres was recently presented at the RSVVW'24
conference. In this supplemental analysis, mRNA-1345 maintained durable
efficacy, with sustained VE of 63.3% (95.88% CI: 48.7%, 73.7%) against RSV-LRTD
including two or more symptoms. VE was 74.6% (95% CI, 50.7-86.9) against
RSV-LRTD with ≥2 symptoms, including shortness of breath and 63.0% (95% CI,
37.3-78.2) against RSV-LRTD including three of more symptoms. The stringent
statistical criterion of the study, a lower bound on the 95% CI of >20%, continued
to be met for both endpoints.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms.
Most people recover within a week or two, but infants and older adults, who are
more vulnerable, can develop severe complications leading to hospitalization.
The rising global incidence of severe RSV in older adults has highlighted the
urgent need for better prevention strategies.
We are well-prepared for the launch of our second respiratory
vaccine, RSV (mRNA-1345), which will build upon the success of
our commercial efforts in the fall COVID-19 market.
We are encouraged by early indications of widespread consumer awareness
and established demand in the RSV market, which we will enter with a strong
competitive profile with robust efficacy data, a well-established safety and
tolerability profile, and as the only pre-filled syringe (PFS) product available at the
time of launch.
With a substantial number of U.S. RSV vaccines given to date in the pharmacy
setting, PFS presentation offers ease of use, time savings and the potential to
reduce medical errors. Given the labor shortage in the retail pharmacy channel,
we anticipate our PFS presentation will be welcomed by pharmacists during the
busy respiratory vaccine season, where pharmacists need, in addition to their
regular tasks, to administer flu, COVID and RSV vaccines.
We have filed for regulatory approvals of our vaccine for the prevention of RSV-
associated lower respiratory tract disease (RSV-LRTD) and acute respiratory
disease (ARD) in adults ages 60 years or older. The regulatory applications
are based on positive data from the pivotal ConquerRSV study, a randomized,
double-blind, placebo-controlled study of approximately 37,000 adults, 60 years
or older. The trial met both its primary efficacy endpoints, with a vaccine
efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD
as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%,
95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. Most
solicited adverse reactions were mild to moderate, and no cases of Guillain-
Barre Syndrome (GBS) have been reported with mRNA-1345 in the Phase 3
RSV trial. These data were published in the New England Journal of Medicine
in December 2023.
14
Advancing mRNA respiratory vaccines
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO A new frontier in cancer care
We, along with our partner Merck, are pioneering a new frontier in the
fight against cancer by researching an mRNA-based investigational
individualized neoantigen therapy (INT) with the goal of targeting
each patient’s unique cancer cells.
Our INT, mRNA-4157, marks an advancement at the intersection of immunology
and cancer biology, leveraging a combination of technological, digital, and
biological innovations. At its heart, this approach is patient-focused, utilizing
next-generation sequencing to identify tumor-specific mutations from a patient’s
blood sample. These mutations are analyzed by a proprietary algorithm to select
up to 34 neoantigens, which are then used to create an individualized mRNA
treatment aimed at training the patient's immune system to recognize and fight
cancer cells. This entire process can be achieved within about six weeks.
mRNA-4157 (V940) in combination with Pembrolizumab reduced the risk of recurrence or death by 44% compared to Pembrolizumab alone
)
%
(
S
F
R
100
80
60
40
20
0
0
12-month
RFS
18-month
RFS
83.4%
78.6%
Events,
% (n/N)
Hazard Ratio
(95% CI)a
mRNA- 4157 (V940) +
Pembrolizumab
22.4 (24/107)
Pembrolizumab
40.0 (20/50)
0.561 (0.309-1.017)
P = 0.0266
20
40
60
80
100
120
140
160
Time from first dose of Pembrolizumab (weeks)
Number at risk
mRNA-4157 (V940) +
Pembrolizumab
Pembrolizumab
107
50
92
42
85
40
73
37
49
28
24
13
20
6
8
1
1
0
1. Khattak A, et al. Presented at the American Association for
Cancer Research® (AACR) Annual Meeting; April 14-19, 2023;
Orlando, FL, USA. Oral presentation CT001.
2. Khattak A, et al. Presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago,
IL, USA. Oral presentation CI, confidence interval; mRNA,
messenger RNA; RFS, recurrence-free survival.aThe hazard
ratio and 95% CI for mRNA-4157 (V940) plus pembrolizumab
versus pembrolizumab is estimated using a Cox proportional
hazards model with treatment group as a covariate, stratified
by disease stage (stages IIIB or IIIC or IIID vs stage IV) used
for randomization. The P value is based on a 1-sided log-rank
test stratified by disease stage (stages IIIB or IIIC or IIID vs
stage IV) used for randomization.
15
A new frontier in cancer care
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO
We made great strides in our INT program in 2023. We announced that in our
Phase 2 study, mRNA-4157, in combination with pembrolizumab, demonstrated
a clinically meaningful improvement in recurrence-free survival and distant
metastasis-free survival compared to standard of care in high-risk resected
melanoma. We saw a 49% reduction in the risk of recurrence or death and
a 62% reduction in the risk of distant metastasis or death compared to
pembrolizumab alone with a median of three years of follow-up, and a Phase 3
pivotal study has begun enrolling.
We have also initiated a Phase 3 trial in non-small cell lung cancer that is actively
enrolling and plan to expand the development program to additional tumor types.
To supply product to these trials and in preparation for the future, we announced
that we are building a manufacturing site in Marlborough, MA as a commercial
INT manufacturing facility.
We believe an individualized neoantigen therapy can be a catalyst for innovation
and drive us toward the next frontier of cancer care. By harnessing the power
of mRNA, we hope to bring this potential therapy to the patients who need it as
Manufacturing site in Marlborough, MA.
quickly as possible.
16
A new frontier in cancer care
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Pipeline
Below is Moderna’s pipeline as of February 22, 2024.
RESPIRATORY VACCINES
Program Indication
ID #
Preclinical
Development
Phase 1
Phase 2
Phase 3
Commercial
Moderna rights
RESPIRATORY VACCINES
COVID-19 vaccine
Spikevax® (mRNA-1273)
Flu vaccine
ADULTS
Older adults RSV vaccine
Flu + COVID vaccine
mRNA-1283
mRNA-1010
mRNA-1020
mRNA-1030
mRNA-1011
mRNA-1012
mRNA-1345
mRNA-1083
Flu + COVID + RSV vaccine
mRNA-1230
Flu + RSV vaccine
Endemic HCoV vaccine
Pandemic Flu
RSV + hMPV vaccine
mRNA-1045
mRNA-1287
mRNA-1018
mRNA-1365
ADOLESCENTS
AND PEDIATRICS
COVID-19 vaccine (adolescents)
mRNA-1273.815
COVID-19 vaccine (pediatrics)
mRNA-1273.815
TeenCOVE
KidCOVE
Pediatric RSV vaccine
mRNA-1345
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Abbreviations:
BARDA: Biomedical Advanced Research
and Development Authority
CMV: cytomegalovirus
CN-1: Crigler-Najjar syndrome type 1
EBV: Epstein-Barr Virus
GSD1a: glycogen storage disease type 1a
HCoV: human coronavirus
HIV: human immunodeficiency virus
hMPV: human metapneumovirus
HSV: herpes simplex virus
IAVI: International AIDS Vaccine Initiative
IL-23: interleukin 23
IL-36 γγ: interleukin 36 gamma
ILCM: Institute for Life Changing Medicine
MMA: methylmalonic acidemia
NIH: National Institutes of Health
NSCLC: non-small cell lung cancer
OTC: ornithine transcarbamylase deficiency
PA: propionic acidemia
PKU: phenylketonuria
RSV: respiratory syncytial virus
VZV: varicella-zoster virus
moderna 2023 annual report
17
Pipeline
Table of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Program Indication
ID #
Preclinical
Development
Phase 1
Phase 2
Phase 3
Commercial
Moderna rights
LATENT & OTHER VACCINES
LATENT VACCINES & OTHER VACCINES
LATENT
VACCINES
CMV vaccine
EBV vaccine
(to prevent infectious mononucleosis)
EBV vaccine
(to address EBV sequelae)
HSV vaccine
VZV vaccine
HIV vaccines
ENTERIC
Norovirus vaccines
BACTERIAL
Lyme vaccines
PUBLIC HEALTH
VACCINES
Zika vaccine
Nipah vaccine
Mpox vaccine
mRNA-1647
mRNA-1189
mRNA-1195
mRNA-1608
mRNA-1468
mRNA-1644
mRNA-1574
mRNA-1403
mRNA-1405
mRNA-1975
mRNA-1982
mRNA-1893
mRNA-1215
mRNA-1769
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide (IAVI funded)
Worldwide (IAVI/others funded)
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide (BARDA funded)
Worldwide (NIH funded)
Worldwide
Abbreviations:
BARDA: Biomedical Advanced Research and
Development Authority
CMV: cytomegalovirus
CN-1: Crigler-Najjar syndrome type 1
EBV: Epstein-Barr Virus
GSD1a: glycogen storage disease type 1a
HCoV: human coronavirus
HIV: human immunodeficiency virus
hMPV: human metapneumovirus
HSV: herpes simplex virus
IAVI: International AIDS Vaccine Initiative
IL-23: interleukin 23
IL-36 γγ: interleukin 36 gamma
ILCM: Institute for Life Changing Medicine
MMA: methylmalonic acidemia
NIH: National Institutes of Health
NSCLC: non-small cell lung cancer
OTC: ornithine transcarbamylase deficiency
PA: propionic acidemia
PKU: phenylketonuria
RSV: respiratory syncytial virus
VZV: varicella-zoster virus
moderna 2023 annual report
18
Pipeline
Table of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Program Indication
ID #
Preclinical
Development
Phase 1
Phase 2
Phase 3
Commercial
Moderna rights
THERAPEUTICS
THERAPEUTICS
SYSTEMIC SECRETED
& CELL SURFACE
THERAPEUTICS
Relaxin
Heart failure
PD-L1
Autoimmune hepatitis
CANCER VACCINES
& THERAPEUTICS
Individualized neoantigen therapy (INT)
–adjuvant melanoma
Individualized neoantigen therapy (INT)
–adjuvant NSCLC
KRAS vaccine
mRNA-0184
mRNA-6981
mRNA-4157
mRNA-4157
mRNA-5671
Checkpoint vaccine
mRNA-4359
INTRATUMORAL
IMMUNO-ONCOLOGY
OX40L/IL-23/IL-36 (Triplet)
Solid tumors/lymphoma
RARE DISEASE
INTRACELLULAR
THERAPEUTICS
PA
MMA
GSD1a
OTC
PKU
CN-1
INHALED PULMONARY
THERAPEUTICS
Cystic fibrosis
mRNA-2752
mRNA-3927
mRNA-3705
mRNA-3745
mRNA-3139
mRNA-3210
mRNA-3351
mRNA-3692 /
VX-522
Worldwide
Worldwide
50-50 global profit sharing with Merck
50-50 global profit sharing with Merck
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Provided to ILCM free of charge
Vertex to pay milestones and royalties
Abbreviations:
BARDA: Biomedical Advanced Research and
Development Authority
CMV: cytomegalovirus
CN-1: Crigler-Najjar syndrome type 1
EBV: Epstein-Barr Virus
GSD1a: glycogen storage disease type 1a
HCoV: human coronavirus
HIV: human immunodeficiency virus
hMPV: human metapneumovirus
HSV: herpes simplex virus
IAVI: International AIDS Vaccine Initiative
IL-23: interleukin 23
IL-36 γγ: interleukin 36 gamma
ILCM: Institute for Life Changing Medicine
MMA: methylmalonic acidemia
NIH: National Institutes of Health
NSCLC: non-small cell lung cancer
OTC: ornithine transcarbamylase deficiency
PA: propionic acidemia
PKU: phenylketonuria
RSV: respiratory syncytial virus
VZV: varicella zoster virus
moderna 2023 annual report
19
Pipeline
Table of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Building our team
Creating a Unique Organization
We continue to focus on the elements of our culture to create an
environment where everyone can have an impact. Our Mission, Values
and Mindsets support our ways of working and unite our people in our
shared goal to change how medicines are made and delivered.
As part of our efforts to scale our culture, we introduced the concept of our
'People Platform' in 2023. This concept involves regularly reviewing the programs
we provide for our employees, the systems that underpin them, and the data and
insights they generate. We aim to ensure that every employee, regardless of their
location or level, experiences the same employee journey and that our culture is
embedded throughout this journey.
We emphasize learning and development. In 2023, we focused on upskilling
our teams on topics such as artificial intelligence (AI) and how AI and machine
learning can help ensure we are digitizing everywhere.
Leading with Belonging
In addition to system-level improvements, we focus heavily on the individual.
Our strategy for diversity and inclusion starts with belonging. We believe that
employees can only thrive and innovate when they feel they belong and can be
their authentic selves.
One achievement we take immense pride in is our commitment to pay equity.
We ensure equal pay for equal work, a commitment we have upheld for the
second year running.
Race & Ethnicity 1
28.0%
21.2%
1/20
12/23
Asian
1. U.S. Only.
8.7%
5.1%
1/20
12/23
Hispanic/
Latinx
7.2%
3.5%
1/20
12/23
Black &
African
American
We also care deeply about our employees' well-being and understand that
each employee has unique needs that change over time. Therefore, we provide
Our workforce demographics show that 49 percent of our employees are
programs that focus on meeting employees where they are and that are tailored
women, with 39 percent female representation in executive roles as of
to their needs. Recently introduced programs include enhanced mental health
December 2023. Although this represents a slight decline from the prior year,
and life insurance benefits.
we are proud of these figures, and have made significant strides in our race and
ethnicity demographics by focusing on our early talent pipeline. Of our inaugural
group of MBA interns, 43 percent identified with races or ethnicities that are
underrepresented.
Our focus remains on creating an inclusive environment where every individual
can thrive and contribute to our mission. We are committed to continuous
learning and improvement in this area, always striving to do better for our people.
20
Building our team
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Celebrating Our Culture
Moderna ranked 9th among
biopharmaceutical companies in this
year’s Science survey. Marking our
ninth consecutive year on this list, we
were recognized for our commitment
to innovative leadership, respect for
employees and corporate social
responsibility.
Additionally, BioSpace named Moderna
the number one large employer in its
Best Places to Work report for the third
year in a row. We were also recognized
by the Human Rights Campaign
Foundation as an Equality 100 company
for the first time in 2023—a proud
moment for Moderna as we continue to
build a culture of belonging.
“
We believe that employees can only thrive and innovate when
they feel they belong and can be their authentic selves. ”
21
Building our team
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Digitizing everywhere
In 2021, when we developed the Moderna Mindsets to help encode our culture,
We are well-positioned to scale our manufacturing and our business overall using
we articulated our commitment to digitizing everywhere possible. Digital
AI because we are a platform company. AI training is required of all Moderna
technology has been part of our programs since our early days and we have
team members and we facilitate this training at a corporate level through our
built our own AI models for protein and mRNA engineering, assay data analyses,
AI Academy. We have challenged everyone across all our business functions
regulatory interaction and many other use cases. As a recent example, we used
to incorporate AI into their everyday workflows. Our AI implementation is
AI to develop an internal scheduling algorithm to optimize our manufacturing
accelerating throughout Moderna, where our secure large language model usage
process for our investigational INT program to account for manufacturing
has grown rapidly to approximately 81 percent of our employee base since its
capacity and target dosing dates for all active patients in our Phase 3 trials
introduction in May 2023.
targeting melanoma and non-small cell lung cancer globally, taking a highly
patient-centric approach.
Percentage of Moderna employees who are active mChat users
100%
80%
60%
40%
20%
81% at
the end
of 2023
4/30
5/14
5/28
6/11
6/25
7/9
7/23
8/6
8/20
9/3
9/17
10/1
10/15
10/29
11/12
11/26
12/10
12/24
22
Digitizing everywhere
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Responsibility
We are guided by our unwavering belief that our mRNA platform can solve
we design our clinical trials to reflect the global community, particularly those
the world’s greatest health challenges—from diseases impacting millions to
disproportionately affected by diseases. We continue to make significant strides
medicines personalized to the individual level. We also operate with a deep
in including medically underserved communities and diverse populations and
sense of purpose and care for our patients, our employees, the environment,
and our communities. We underscored our commitment to responsible
corporate citizenship through the publication of our second annual ESG Report
in June 2023.
Prioritizing Inclusive Research
have set a standard in our healthy volunteer clinical trials with at least 37 percent
of trial participants from global ethnic majority groups, at least half being female,
and representation across all age groups. We are proud to not just meet industry
expectations but set and exceed them in every demographic category.
To sustain our drive toward inclusive research, we concentrate our efforts around
three pillars: increasing awareness, bringing trials into communities, and providing
In 2023, we remained steadfast in our commitment to inclusive research,
flexible participation options. This approach has led to increased enrollment,
developing mRNA-based investigational therapies and vaccines that are
retention, and participant satisfaction. At its core, our commitment to innovative
equitable for all. Recognizing the importance of diversity for scientific excellence,
and inclusive clinical trials helps to ensure that potential medicines of tomorrow
are accessible to all.
Focusing on Global Public Health
In 2023, we continued to leverage our mRNA platform to address potential global
public health threats and build pandemic preparedness, addressing priority
pathogens that represent high disease burden, especially in low- and middle-
income countries.
23
Responsibility
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Our mRNA Access global partners1:
1. non-exhaustive
Moderna's global public health portfolio, launched in 2022, continues to evolve,
with advanced clinical trials against diseases such as Zika, Mpox, HIV, and Nipah.
Our focus has expanded to include other respiratory threats like pandemic
influenza, with our mRNA-1018 program making strides in clinical testing. Through
our mRNA Access program, we have increased collaborations and opened
preclinical production capabilities to more academic institutions worldwide,
decentralizing the research and development of mRNA vaccines. We are also
developing new manufacturing sites in Australia, Canada and the U.K. to enhance
our ability to swiftly respond to potential regional and global pandemic outbreaks.
In October 2023, we entered into a strategic partnership with the Coalition
for Epidemic Preparedness Innovations (CEPI) with the goal of harnessing
Moderna's mRNA platform to accelerate the development of vaccines against
viral disease outbreaks that threaten global health. The work undertaken as
part of this partnership could expand the infectious disease targets for mRNA
vaccine technology and strengthen pandemic preparedness and public health
efforts in alignment with the 100 Days Mission, a global goal to compress vaccine
development timelines to 100 days.
Building the Moderna Charitable Foundation
The Moderna Charitable Foundation continues to make a positive impact in our
communities locally and globally. Through philanthropic giving, employee gift
matching, and humanitarian relief, the Moderna Foundation supported nonprofit
organizations with $8.5 million in grants in 2023, with a significant focus on
improving health systems in sub-Saharan Africa. Partnerships with organizations
such as Science Club for Girls, CDC Foundation, Imperial College London, and
Amref Health Africa further advance the Foundation’s mission to promote public
health, advance scientific education, and advocate for diversity and inclusion.
24
Responsibility
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Giving Back to the Community
Protecting the Environment
Our commitment to serve the communities where we live and work has always
In 2023, we advanced our environmental sustainability efforts underlined by a
been part of our identity, and we constantly strive to extend our impact on
strategy focused on Sustainability by Design, Natural Resource Conservation,
society. Each year between Giving Tuesday and International Volunteer Day,
and Value Chain Decarbonization. We have launched initiatives like a climate
we organize a company-wide Volunteer Week. 2023 marked our fifth annual
risk and scenario analysis, increased public greenhouse gases (GHG) emissions
Volunteer Week, and hundreds of Moderna team members participated in
disclosures, and incorporated energy-saving technologies in new constructions.
organized activities across 15 countries, up from six in 2022, to make a substantial
We are also working to reduce Scope 3 emissions with suppliers and promoting
impact with community partners around the world.
green employee transport. As Moderna prepares for 2024, we aim to further
All our team members receive eight hours of paid time off each year to dedicate
toward volunteering, and our Dollars for Doers program matches additional
volunteer time at a specific hourly rate. Additionally, the Moderna Charitable
Foundation matches monetary donations that employees have made to qualified
charitable organizations. In 2023, our collective efforts supported more than
2,000 nonprofits around the world, with 70 percent of our workforce engaging in
giving and/or volunteering.
integrate climate risk management, validate our GHG emissions reduction
roadmap by Science Based Targets initiative (SBTi), and enhance energy,
emissions, and waste programs, reinforcing our commitment to environmental
stewardship as part of our healthcare mission.
25
Responsibility
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Leadership
Executive Committee
In order left to right
Stephen Hoge, MD | President
Stéphane Bancel | Chief Executive Officer
Tracey Franklin | Chief Human Resources Officer
Kate Cronin | Chief Brand Officer
Jerh Collins, PhD | Chief Technical Operations
and Quality Officer
Shannon Thyme Klinger | Chief Legal Officer
and Corporate Secretary
Brad Miller | Chief Information Officer
Jamey Mock | Chief Financial Officer
Board of Directors
Noubar Afeyan, PhD | Co-founder and
Chairman, Moderna; Chief Executive
Officer, Flagship Pioneering
Stéphane Bancel | Chief Executive
Officer, Moderna
Stephen Berenson | Managing Partner,
Flagship Pioneering
Sandra Horning, MD | Former Chief
Medical Officer and Global Head of
Product Development, Roche
Robert Langer, ScD | Academic
Co-Founder, Moderna; David H. Koch
Institute Professor, MIT
Elizabeth Nabel, MD | Former President,
Brigham Health
François Nader, MD | Former President,
CEO and Executive Director, NPS
Pharmaceuticals
Paul Sagan | Catalyst Advisor,
General Catalyst
Elizabeth Tallett | Former Principal,
Hunter Partners
In Memoriam, Henri Termeer |
Retired Chairman, President and CEO
of Genzyme
26
Leadership
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Table of
Contents
A letter from
our CEO
Advancing mRNA
respiratory vaccines
A new frontier
in cancer care
Pipeline
Building
our team
Digitizing
everywhere
Responsibility
Leadership Awards and
recognition
Financials
Awards and recognition highlights
BioSpace Best
Places to Work
Ranked no. 1
large company
on 2024 list
Boston Consulting
Group’s 50 Most
Innovative Report
Ranked no. 6
on 2023 list
Deloitte's Technology
Fast 500 List
Ranked no. 4
on the 2023 list
Disability Equality
Index’s Best Places
to Work
Scored 100/100
in 2023
Edison Gold Award
Awarded in 2023 for
Advanced Drug Delivery:
COVID-19 Vaccine
Financial Times
Americas’ Fastest
Growing Companies
Ranked no. 5
in 2023
Fortune 500 List
Ranked no. 211
on the 2023 list
Fortune’s World’s
Most Admired
Companies
Ranked no. 37
on 2024 list
Great Place to Work
Certified in U.S. in 2023
Human Rights
Campaign Foundation’s
Corporate Equality
Index
Scored 100/100 in 2023
Science Careers’
Top Employers
Ranked for nine
consecutive years;
no. 9 on 2023 list
Vaccine Industry
Excellence Award
Awarded for Best COVID
Vaccine in 2023
Moderna's locations around the world
Canada
United States
Norway
Sweden
Denmark
Poland
Germany
Switzerland
Netherlands
United
Kingdom
France
Spain
Italy
South Korea
Japan
Hong Kong
Taiwan
Singapore
Australia
moderna 2023 annual report
27
Awards and recognition highlights
Consolidated Balance Sheets
(in millions)
Assets
Current assets:
Cash and cash equivalents
Investments
Accounts receivable, net
Inventory
Prepaid expenses and other current assets
Total current assets
Investments, non-current
Property, plant and equipment, net
Right-of-use assets, operating leases
Deferred tax assets
Other non-current assets
Total assets
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
Accrued liabilities
Deferred revenue
Income taxes payable
Other current liabilities
Total current liabilities
Deferred revenue, non-current
Operating lease liabilities, non-current
Financing lease liabilities, non-current
Other non-current liabilities
Total liabilities
Stockholders’ equity:
Additional paid-in capital
Accumulated other comprehensive loss
Retained earnings
Total stockholders’ equity
Total liabilities and stockholders’ equity
$
$
$
December 31,
2023
2022
2,907 $
5,697
892
202
627
10,325
4,677
1,945
713
81
685
3,205
6,697
1,385
949
1,195
13,431
8,318
2,018
121
982
988
18,426 $
25,858
520 $
1,798
568
63
66
3,015
83
643
575
256
4,572
371
(123)
13,606
13,854
487
2,101
2,038
48
249
4,923
673
92
912
135
6,735
1,173
(370)
18,320
19,123
$
18,426 $
25,858
The Consolidated Balance Sheets have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K.
28
Consolidated Balance Sheets
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Consolidated Statements of Operations
(in millions, except per share data)
Revenue:
Net product sales
Other revenue1
Total revenue
Operating expenses:
Cost of sales
Research and development
Selling, general and administrative
Total operating expenses
(Loss) income from operations
Interest income
Other expense, net
(Loss) income before income taxes
(Benefit from) provision for income taxes
Net (loss) income
(Loss) earnings per share:
Basic
Diluted
Weighted average common shares used in calculation of (loss) earnings per share:
Basic
Diluted
1.
Includes grant revenue and collaboration revenue
Years Ended December 31,
2023
2022
$
6,671 $
177
6,848
4,693
4,845
1,549
11,087
(4,239)
421
(124)
(3,942)
772
(4,714) $
(12.33) $
(12.33) $
382
382
$
$
$
18,435
828
19,263
5,416
3,295
1,132
9,843
9,420
200
(45)
9,575
1,213
8,362
21.26
20.12
394
416
The Consolidated Statements of Operations have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K.
29
Consolidated Statements of Operations
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Consolidated Statements of Cash Flows
Years Ended December 31,
(in millions)
Operating activities
Net (loss) income
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:
2023
$
(4,714) $
Stock-based compensation
Depreciation and amortization
Amortization/accretion of investments
Loss on equity investments, net
Deferred income taxes
Other non-cash items
Changes in assets and liabilities, net of acquisition of business:
Accounts receivable, net
Prepaid expenses and other assets
Inventory
Right-of-use assets, operating leases
Accounts payable
Accrued liabilities
Deferred revenue
Income taxes payable
Operating lease liabilities
Other liabilities
Net cash (used in) provided by operating activities
Investing activities
Purchases of marketable securities
Proceeds from maturities of marketable securities
Proceeds from sales of marketable securities
Purchases of property, plant and equipment
Acquisition of business, net of cash acquired
Investment in convertible notes and equity securities
Net cash provided by (used in) investing activities
Financing activities
Proceeds from issuance of common stock through equity plans
Repurchase of common stock, including excise tax
Changes in financing lease liabilities
Net cash used in financing activities
Net decrease in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash, beginning of year
Cash, cash equivalents and restricted cash, end of period
305
621
(61)
35
828
7
493
974
747
(605)
13
(340)
(2,060)
15
551
73
(3,118)
(3,760)
5,575
3,206
(707)
(85)
(23)
4,206
46
(1,153)
(270)
(1,377)
(289)
3,217
2,928 $
$
2022
8,362
226
348
31
—
(559)
28
1,790
(1,699)
492
21
240
612
(4,157)
(828)
(14)
88
4,981
(11,435)
3,151
3,548
(400)
—
(40)
(5,176)
65
(3,329)
(184)
(3,448)
(3,643)
6,860
3,217
The Consolidated Statements of Cash Flows have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K.
30
Consolidated Statements of Cash Flows
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO Forward-Looking Statements Disclaimer
This annual report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the potential of Moderna’s mRNA
platform; Moderna’s ability to bring medicines to market; Moderna’s expectation that its COVID-19 franchise will be profitable for 2024 and beyond; Moderna’s ability to compete in the commercial
market and future market share; the potential 2024 launch of Moderna’s RSV vaccine for adults with a potentially best-in-class profile; our ability to compete in the RSV market, and the advantages
of our PFS presentation; the safety and tolerability profile of Moderna’s mRNA vaccine technology; Moderna’s intent to launch up to 15 products in five years; the potential for approval of Moderna’s
seasonal flu vaccine candidate and the timing for that approval; the anticipated benefits of combination vaccines, and Moderna’s intent to have a flu/COVID combination vaccine available as early as
2025; the clinical benefit observed with Moderna’s mRNA cancer therapy; Moderna's plans to expand INT to additional tumor types; Moderna’s construction of a factory to support INT; the promise of
Moderna’s rare disease franchise; the expected read out in 2024 for Moderna’s mRNA therapy for cystic fibrosis and potential readout for CMV; Moderna’s ability to scale its manufacturing and business
overall using AI; Moderna’s expectation to be in sales growth by 2025 and to break even in 2026; Moderna’s expectation to double the number of programs in Phase 3 by 2025; and the timing and scale
for Moderna’s planned investments in research and development. The forward-looking statements in this annual report are neither promises nor guarantees, and you should not place undue reliance
on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual
results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under
the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent
filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this annual report in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current
expectations and speak only as of the date of this annual report.
31
moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO