SARS-CoV-2 Variant Booster Program
Update: Single booster dose of 50 µg of mRNA-1273 or
mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and
two Variants of Concern (B.1.351, P.1) in previously vaccinated
clinical trial participants
TeenCOVE Study Update: Initial analysis
of the Phase 2/3 TeenCOVE study of mRNA-1273 showed vaccine
efficacy against COVID-19 of 96%; mRNA-1273 was generally well
tolerated with no serious safety concerns identified to date
2021 and 2022 Vaccine Manufacturing:
Company increased its 2021 supply forecast to between 800 million
and 1 billion doses; Company making investments to increase global
supply for COVID-19 Vaccine to up to 3 billion doses in 2022
Company plans to initiate rolling submission
for BLA in the U.S. this month
First patient dosed in Phase 1/2 study of
propionic acidemia (PA) candidate (mRNA-3927); Company now has
infectious disease, cardiovascular, oncology and rare disease
programs in the clinic
Company increases R&D investments in
infectious diseases and other therapeutic areas to increase new
development candidates from the lab to the clinic
First GAAP profitable quarter in Company
history
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today reported
financial results and provided business updates for the first
quarter 2021 and highlighted pipeline progress.
“In the first quarter, the Moderna team delivered on its supply
commitments to many governments and helped protect more than 100
million people. This accomplishment translated into our first
profitable quarter in the company’s history, after 10 years of
scientific innovation and several billion dollars invested to make
our mRNA platform a reality,” said Stéphane Bancel, Chief Executive
Officer of Moderna. “Based on these first quarter accomplishments
and our current manufacturing scale-up trajectory, we were pleased
to again increase our base plan for 2021 to 800 million doses. The
Moderna team and our manufacturing partners are working hard to get
as close to 1 billion doses in 2021 as we can. The feedback from
governments around the world requesting high-efficacy mRNA vaccines
and variant boosters is overwhelming. We are now actively engaged
in discussions and agreements for 2022 with all of the governments
we are currently supplying for 2021. On top of that, new
partnerships, like COVAX, for up to 466 million doses in 2022 and
discussions with new governments in Asia, Middle East, Africa and
Latin America, make us believe that our total advance purchase
agreements for 2022 should be higher than those in 2021.”
New updates and recent progress include:
COVID-19 Vaccine Development
- Increased 2021 supply forecast to between 800 million and 1
billion doses; making additional investments to increase global
supply for COVID-19 Vaccine to up to 3 billion doses in 2022
(depending on the mix)
- Company recently announced data supporting 3-month refrigerated
(2-8°C) stable formulation
- New data shows a single booster dose of 50 µg of mRNA-1273 or
mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and
two variants of concern (B.1.351, P.1) in previously vaccinated
clinical trial participants
- Initial analysis of Phase 2/3 TeenCOVE study of mRNA-1273 in
adolescents ages 12 to 17 years showed vaccine efficacy against
COVID-19 of 96%; mRNA-1273 was generally well tolerated with no
serious safety concerns identified to date
- Phase 3 study of mRNA-1273 in adults with a kidney or liver
transplant is ongoing
- Company plans to initiate rolling submission for BLA in the
U.S. this month
Infectious Diseases
- Positive interim data from Phase 1 study of RSV vaccine
candidate (mRNA-1345) in younger adults (ages 18-49 years)
- Positive seven-month interim data from Phase 2 study of
cytomegalovirus (CMV) vaccine candidate (mRNA-1647) announced
during Vaccines Day on April 14; Moderna preparing for pivotal
Phase 3 study expected to begin in 2021
Rare Diseases
- First patient dosed in Propionic Acidemia (mRNA-3927) Phase 1/2
Paramount study
Moderna currently has 24 mRNA development programs in its
portfolio with 14 having entered clinical studies. The Company’s
updated pipeline can be found at www.modernatx.com/pipeline.
Moderna and collaborators have published more than 65 peer-reviewed
papers.
Summary of Program Highlights by Modality
Core Modalities
Prophylactic Vaccines: Moderna is developing vaccines
against viral diseases where there is unmet medical need –
including complex vaccines with multiple antigens for common
diseases, as well as vaccines against threats to global public
health. The Company’s global public health portfolio is focused on
epidemic and pandemic diseases for which funding has been sought
from governments and non-profit organizations.
COVID-19 Vaccine Development
- Moderna COVID-19 Vaccine: The Company shared an update
on the Phase 3 COVE study of the Moderna COVID-19 Vaccine
(mRNA-1273) at its annual Vaccines Day on April 14, 2021. An
updated review of adjudicated cases identified over 900 cases of
COVID-19 in the COVE study as of April 9th, including over 100
cases of severe COVID-19, as defined in the protocol, with a median
follow-up of approximately 6 months post dose 2. Vaccine efficacy
starting two weeks following the second dose and based on the
updated adjudicated cases remains consistent with prior updates,
including greater than 90% efficacy against all cases of COVID-19,
and greater than 95% efficacy against severe cases of COVID-19. The
COVE study is ongoing and reported results remain preliminary.
Throughout the year, Moderna will be sharing updated data from the
Phase 3 COVE study including efficacy against asymptomatic
infection, genotyping data, additional antibody persistence data
and information regarding potential correlates of protection.
Moderna has also received emergency (or other conditional, interim
or provisional) authorization for use of its COVID-19 vaccine from
health agencies in Canada, Israel, the European Union, the United
Kingdom, Switzerland, Singapore, Qatar, Taiwan, the World Health
Organization (WHO), and the Philippines. The Company plans to
initiate rolling submission for a Biologics License Application
(BLA) for the vaccine in the U.S. this month. Moderna is working
with additional health agencies on the authorization of its vaccine
in additional jurisdictions. BARDA, part of the Office of the
Assistant Secretary for Preparedness and Response (ASPR) within the
U.S. Department of Health and Human Services (HHS), partially
supported the research and development of the Moderna COVID-19
Vaccine with federal funding under Contract no. 75A50120C00034.
Moderna retains worldwide rights to develop and commercialize the
Moderna COVID-19 Vaccine.
- Temperature Stability Update: Moderna recently announced
that ongoing development data related to the current formulation of
the Moderna COVID-19 Vaccine (mRNA-1273) could support a 3-month
refrigerated (2-8°C) shelf life for the vaccine in alternative
formats to facilitate easier distribution to doctor’s offices and
other smaller settings, if authorized. Currently, the Moderna
COVID-19 Vaccine is approved for storage up to 1 month at
refrigerated temperatures (2-8°C) and up to 7 months in a standard
freezer (-20°C). The Moderna COVID-19 Vaccine is also the only
authorized mRNA vaccine that does not require on-site dilution. The
Company also announced that it is working on formulations of
mRNA-1273 and a next generation vaccine (mRNA-1283) that it
believes will extend refrigerated shelf life even further.
- Publication of Note: Antibody persistence data out to 6
months following the second dose of the Moderna COVID-19 Vaccine
were recently published in The New England Journal of Medicine.
This study analyzed 33 healthy adult participants in the NIH-led
Phase 1 study of Moderna’s COVID-19 Vaccine at 6 months following
the second 100 μg dose (day 209). As detected by three distinct
serologic assays, antibodies elicited by the Moderna COVID-19
Vaccine persisted through 6 months after the second dose. Antibody
decay was estimated using two approaches and was consistent with
published observations of convalescent patients with COVID-19
through 8 months after symptom onset.
- Addressing Variants of Concern: On February 24, Moderna
announced that it completed manufacturing of clinical trial
material for its variant-specific vaccine candidate, mRNA-1273.351,
against the SARS-CoV-2 variant known as B.1.351 first identified in
the Republic of South Africa and has shipped doses to the NIH for a
Phase 1 clinical trial that will be led and funded by the NIH’s
NIAID. The Company also provided an update on its strategy for
addressing SARS-CoV-2 variants of concern.
- Publication of Note: Initial data from Moderna’s Phase 2
study showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351
given as a booster to previously vaccinated individuals increased
neutralizing antibody titer responses against SARS-CoV-2 and two
variants of concern, B.1.351 (first identified in South Africa) and
P.1 (first identified in Brazil). A booster dose of mRNA-1273.351,
the Company’s strain-matched booster, achieved higher neutralizing
antibody titers against the B.1.351 variant of concern than a
booster dose of mRNA-1273. Safety and tolerability profiles
following third dose booster injections of 50 µg of mRNA-1273 or
mRNA-1273.351 were generally comparable to those observed after the
second dose of mRNA-1273 in the previously reported Phase 2 and
Phase 3 studies.
- Publication of Note: Preclinical data on the Company’s
variant booster vaccine candidates have been submitted as a
preprint to bioRxiv showed that both mRNA-1273.351 and
mRNA-1273.211 increase neutralizing titers against SARS-CoV-2
variants of concern in mice. Specifically, this preclinical data
confirms improved neutralizing titers with the mRNA-1273.351
vaccine primary series. The multi-valent vaccine provided the
broadest level of immunity. A boost at 6 months with mRNA-1273.351
closed the neutralizing titer gap for the variants of concern.
Following the mRNA-1273.351 boost, neutralizing titers were
comparable between the ancestral strain (Wuhan) and the new B.1.351
variant.
- Further Clinical Studies of mRNA-1273
- Phase 2/3 “TeenCOVE” study of mRNA-1273 in adolescents:
The Phase 2/3 study of mRNA-1273 in adolescents ages 12-17 years
has completed enrollment in the U.S. An initial analysis of 3,235
participants randomized 2:1 in TeenCOVE Study showed a vaccine
efficacy rate of 96% in seronegative participants who received at
least one injection. The analysis included 12 cases starting 14
days after first dose and based on the CDC definition of COVID-19,
which requires one COVID-19 symptom and paired with a
nasopharyngeal (NP) swab or saliva sample positive for SARS-CoV-2
by RT-PCR. Because the incidence rate of COVID-19 is lower in
adolescents, the case definition is less stringent than for COVE,
resulting in vaccine efficacy against milder disease. The median
duration for follow-up in this initial analysis was 35 days
following the second dose. mRNA-1273 was generally well tolerated.
The majority of adverse events were mild or moderate in severity.
No serious safety concerns have been identified to date. The most
common solicited local adverse event was injection site pain. The
most common solicited systemic adverse events after the second dose
of mRNA-1273 were headache, fatigue, myalgia and chills. The
Company is continuing to collect data in TeenCOVE and is in
discussions with regulators about a potential amendment to its
regulatory filings.
- Phase 2 “KidCOVE” study of mRNA-1273 in young children:
The Phase 2 study of mRNA-1273 in pediatric population ages 6
months to 11 years is ongoing.
- Phase 1/2 study of mRNA-1273 in Japan: The Phase 1/2
study of Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or
TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd is
ongoing.
- Phase 3 “COVE Transplant” study of mRNA-1273: The Phase
3 study of mRNA-1273 in adults with a kidney or liver transplant is
ongoing.
- Next-generation vaccine against COVID-19 (mRNA-1283):
The Phase 1 study of mRNA-1283 is ongoing. mRNA-1283 is a
next-generation vaccine candidate against COVID-19 that encodes for
the portions of the SARS-CoV-2 spike protein critical for
neutralization, specifically the Receptor Binding Domain (RBD) and
N-terminal Domain (NTD). The encoded mRNA-1283 antigen is shorter
than mRNA-1273 and is being developed as a potential refrigerator
stable mRNA vaccine that will facilitate easier distribution and
administration by healthcare providers. mRNA-1283 is intended to be
evaluated for use as a booster dose for previously vaccinated or
infected individuals as well as in a primary series for
seronegative individuals.
Vaccines requiring complex antigens and against highly prevalent
infections
- Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive
seven-month data from the Phase 2 study assessing the safety,
reactogenicity, and immunogenicity of different dose levels (50 μg,
100 μg and 150 μg) of mRNA-1647 were presented at Moderna’s annual
Vaccines Day on April 14, 2021. mRNA-1647 was generally well
tolerated. The most common solicited local adverse reaction (AR)
was injection site pain and the most common solicited systemic ARs
were headache, fatigue, myalgia, arthralgia and chills. Rates of
Grade 3 solicited ARs after the third vaccination were similar to,
or lower than the rates of Grade 3 solicited ARs after the second
vaccination. In CMV-seronegative participants in mRNA-1647
treatment groups after the third vaccination, neutralizing antibody
geometric mean titers (GMTs) against epithelial cell infection were
at least 20-fold higher than the baseline GMT of the
CMV-seropositive group and neutralizing antibody GMTs against
fibroblast infection approximated the baseline GMT of the
CMV-seropositive group. In CMV positive participants in mRNA-1647
treatment groups after the third vaccination: neutralizing antibody
GMTs against epithelial cell infection increased to at least
6.8-fold over baseline and neutralizing antibody GMTs against
fibroblast infection increased to approximately 2-fold over
baseline. Based on the interim analysis of the Phase 2 study, the
100 μg dose has been chosen for the Phase 3 pivotal study, which is
expected to begin in 2021. Moderna owns worldwide commercial rights
for mRNA-1647.
- Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189
is a vaccine against EBV containing five mRNAs that encode viral
proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna’s
CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are
expressed in their native membrane-bound form for recognition by
the immune system. Moderna is planning to begin a Phase 1 study of
mRNA-1189 in 2021. There is no approved vaccine for EBV. Moderna
owns worldwide commercial rights to mRNA-1189.
Vaccines against respiratory infections
- Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3)
vaccine (mRNA-1653): Moderna is enrolling seropositive
pediatric participants (12-36 months of age) in the Phase 1 study
of hMPV/PIV3 study (mRNA-1653). The first cohort in this study has
been fully enrolled. Moderna owns worldwide commercial rights to
mRNA-1653.
- Respiratory syncytial virus (RSV) vaccine (mRNA-1345):
mRNA-1345 is a vaccine against RSV encoding for a prefusion F
glycoprotein, which elicits a superior neutralizing antibody
response compared to the postfusion state. RSV is the leading cause
of respiratory illness in young children. Older adults (65+) are at
high risk for severe RSV infections. mRNA-1345 uses the same lipid
nanoparticle (LNP) as Moderna’s authorized COVID-19 vaccine and
contains optimized protein and codon sequences. The Phase 1 study
of mRNA-1345 to evaluate the tolerability and reactogenicity of
mRNA-1345 in younger adults, older adults and children is ongoing.
All four cohorts of younger adults (ages 18-49 years) are fully
enrolled. Dosing in the older adult cohort (ages 65-79 years) is
ongoing. The age range of toddlers in this de-escalation Phase 1
study is 12-59 months. The Company shared the first interim
analysis of the Phase 1 study of mRNA-1345, through 1-month
post-vaccination, of the younger adult cohorts at its annual
Vaccines Dayon April 14, 2021. The Company also intends to evaluate
the potential of combinations of mRNA-1345 with its vaccines
against other respiratory pathogens in children and separately in
older adults. There is no approved vaccine for RSV. Moderna owns
worldwide commercial rights to mRNA-1345.
- Seasonal influenza vaccine (mRNA-1010, mRNA-1020,
mRNA-1030): Seasonal flu (type A and type B) epidemics occur
seasonally and vary in severity each year, causing respiratory
illnesses and placing substantial burden on healthcare systems. The
World Health Organization (WHO) estimates approximately 3-5 million
severe cases of flu each year globally, and 290,000-650,000
flu-related respiratory deaths. Approximately 8% of the U.S.
population experiences symptoms from flu each year. In the U.S.,
the estimated average economic burden of flu is approximately $11
billion per year. Current flu vaccines are only approximately
40-60% effective and their formulation is decided 9 months before
the vaccines are intended to be used. Egg-based vaccine production
also has the potential to cause unintended antigenic change to the
vaccine virus. The Company plans to explore potential combination
vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus
(hMPV). The Company’s first-generation flu program will evaluate
multiple candidates comprising multiple antigen combinations
against the four seasonal viruses recommended by the WHO. The
Company expects to begin a Phase 1 clinical trial for the program
in 2021.
Public health vaccines
- Zika virus vaccine (mRNA-1893):Moderna is preparing for
a Phase 2 study of mRNA-1893, which is expected to begin in 2021.
mRNA-1893 is being developed in collaboration with BARDA. Moderna
owns worldwide commercial rights to mRNA-1893.
- HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the
virus responsible for acquired immunodeficiency syndrome (AIDS), a
lifelong, progressive illness with no effective cure. Approximately
38 million people worldwide are currently living with HIV with 1.2
million in the U.S. Approximately 2 million new infections of HIV
are acquired worldwide every year and approximately 690,000 people
die annually due to complications from HIV/AIDS. The primary routes
of transmission are sexual intercourse and IV drug use, putting
young adults at the highest risk of infection. From 2000 to 2015, a
total of $562.6 billion globally was spent on care, treatment and
prevention of HIV, representing a significant economic burden.
mRNA-1644, a collaboration with the International AIDS Vaccine
Initiative (IAVI) and the Bill and Melinda Gates Foundation, is a
novel approach to HIV vaccine strategy in humans designed to elicit
broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1 study for
mRNA-1644 will use iterative human testing to validate the approach
and antigens and multiple novel antigens will be used for
germline-targeting and immuno-focusing. A second approach,
mRNA-1574, is being evaluated in collaboration with the NIH and
includes multiple native-like trimer antigens. The Company expects
to begin Phase 1 studies for both mRNA-1644 and mRNA-1574 in
2021.
- Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic
virus transmitted to humans from animals, contaminated food, or
through direct human-to-human transmission and causes a range of
illnesses including fatal encephalitis. Severe respiratory and
neurologic complications of NiV have no treatment other than
intensive supportive care. The case fatality rate among those
infected is estimated at 40-75%. NiV outbreaks cause significant
economic burden to impacted regions due to loss of human life and
interventions to prevent further spread, such as the slaughter of
infected animals. NiV has been identified as the cause of isolated
outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000
and is included on the WHO R&D Blueprint list of epidemic
threats needing urgent R&D action. mRNA-1215 was co-developed
by Moderna and the NIH’s Vaccine Research Center (VRC).
- Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions
regarding funding the Company’s pandemic influenza/H7N9 vaccine
program through approval are ongoing.
Systemic Secreted & Cell Surface Therapeutics: In
this modality, mRNA is delivered systemically to create proteins
that are either secreted or expressed on the cell surface.
- Antibody against the chikungunya virus (mRNA-1944):
Positive interim data from the Phase 1 study evaluating escalating
doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication
cohort and two doses of 0.3 mg/kg (without steroid premedication)
given one week apart cohort were presented at Moderna’s annual
R&D Day in September and demonstrated dose-dependent increases
in levels of antibody against chikungunya. Safety and increased
CHKV-IgG production in the two-dose regimen shows the platform’s
ability for repeat dosing.
- IL-2 (mRNA-6231): mRNA-6231 is an mRNA encoding for a
long-acting tolerizing IL-2. This autoimmune development candidate
is designed to preferentially activate and expand the regulatory T
cell population. The Company plans to conduct a Phase 1 study of
mRNA-6231 in healthy adult volunteers. mRNA-6231 uses the same LNP
formulation as mRNA-1944. The Phase 1 study of mRNA-6231 will be
the first clinical demonstration of subcutaneous administration of
this delivery technology. Moderna owns worldwide commercial rights
to mRNA-6231.
- PD-L1 (mRNA-6981): mRNA-6981 is an mRNA encoding for
PD-L1. This autoimmune development candidate is designed to augment
cell surface expression of PD-L1 on myeloid cells to provide
co-inhibitory signals to self-reactive lymphocytes. As an initial
step to addressing a range of autoimmune indications, the Company
intends to pursue proof-of-concept in a Phase 1 study of mRNA-6981
in type 1 autoimmune hepatitis (AIH), a condition that involves
liver inflammation and can lead to cirrhosis and liver failure.
mRNA-6981 uses the same LNP formulation as mRNA-1944. Moderna owns
worldwide commercial rights to mRNA-6981.
- Relaxin (AZD7970): Moderna has regained all rights to
the Relaxin development candidate from AstraZeneca. Moderna now
owns worldwide commercial rights to this development
candidate.
Exploratory Modalities
Cancer Vaccines: These programs focus on stimulating a
patient’s immune system with antigens derived from tumor-specific
mutations to enable the immune system to elicit a more effective
anti-tumor response.
- Personalized cancer vaccine (PCV) (mRNA-4157): The
randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in
combination with Merck’s pembrolizumab (KEYTRUDA®), compared to
pembrolizumab alone, for the adjuvant treatment of high-risk
resected melanoma is ongoing. Phase 1 in multiple cohorts is
ongoing. The upsized head & neck cohort is recruiting
additional patients. Moderna shares worldwide commercial rights to
mRNA-4157 with Merck.
- Mutant KRAS vaccine (mRNA-5671 or V941): The Phase 1
open-label, multi-center study to evaluate the safety and
tolerability of mRNA-5671 both as a monotherapy and in combination
with pembrolizumab, led by Merck, is ongoing. Moderna shares
worldwide commercial rights to mRNA-5671 with Merck.
Intratumoral Immuno-Oncology: These programs aim to drive
anti-cancer T cell responses by injecting mRNA therapies directly
into tumors.
- OX40L (mRNA-2416): The Phase 1/2 study of mRNA-2416
alone and in combination with durvalumab (IMFINZI®) is ongoing. The
Phase 2 dose expansion study of mRNA-2416 in combination with
durvalumab in ovarian cancer patients is enrolling and the first
patients have been dosed. Moderna owns worldwide commercial rights
to mRNA-2416.
- OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The Phase 1
trial evaluating mRNA-2752 as a single agent and in combination
with durvalumab in patients with advanced solid tumor malignancies
and lymphoma is ongoing. mRNA-2752 is an investigational mRNA
immuno-oncology therapy that encodes a novel combination of three
immunomodulators. Moderna owns worldwide commercial rights to
mRNA-2752.
- IL-12 (MEDI1191): The Phase 1 open-label, multi-center
study of intratumoral injections of MEDI1191 alone and in
combination with durvalumab in patients with advanced solid tumors,
led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for
IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide
commercial rights to MEDI1191 with AstraZeneca.
Localized Regenerative Therapeutics: Localized production
of proteins has the potential to be used as a regenerative medicine
for damaged tissues.
- VEGF-A (AZD8601): The Phase 2a study of AZD8601 VEGF-A,
which is being developed for patients with ischemic heart disease
undergoing coronary artery bypass grafting (CABG) surgery with
moderately impaired systolic function, led by AstraZeneca, is
ongoing. Moderna has licensed worldwide commercial rights to
AZD8601 to AstraZeneca.
Systemic Intracellular Therapeutics: These programs aim
to deliver mRNA into cells within target organs as a therapeutic
approach for diseases caused by a missing or defective protein.
- Propionic acidemia (PA) (mRNA-3927): The first patient
in the Phase 1/2 Paramount studyof mRNA-3927 has been dosed.
mRNA-3927 uses the same LNP formulation as mRNA-1944. This is the
Company’s first development candidate in its systemic intracellular
therapeutics modality to enter the clinic. Moderna owns worldwide
commercial rights to mRNA-3927.
- Methylmalonic acidemia (MMA) (mRNA-3705): Moderna
received rare pediatric designation for its next generation MMA
candidate (mRNA-3705). The Company plans to file new IND and CTA
applications for mRNA-3705 and will focus development efforts on
that candidate going forward. mRNA-3705 uses the same LNP
formulation as mRNA-1944. Moderna owns worldwide commercial rights
to mRNA-3705.
- Phenylketonuria (PKU) (mRNA-3283): Individuals with PKU
have a deficiency in phenylalanine hydroxylase (PAH) resulting in a
reduced or complete inability to metabolize the essential amino
acid phenylalanine into tyrosine. mRNA-3283 encodes human PAH to
restore the deficient or defective intracellular enzyme activity in
patients with PKU. mRNA-3283 is in preclinical development. Moderna
owns worldwide commercial rights to mRNA-3283.
- Glycogen storage disease type 1a (GSD1a) (mRNA-3745):
Individuals with GSD1a have a deficiency in glucose-6-phosphatase
resulting in pathological blood glucose imbalance. mRNA-3745 is an
IV-administered mRNA encoding human G6Pase enzyme, designed to
restore the deficient or defective intracellular enzyme activity in
patients with GSD1a. mRNA-3745 is in preclinical development.
Moderna owns worldwide commercial rights to mRNA-3745.
Information about each development candidate in Moderna’s
pipeline can be found on the investor relations page of its
website: investors.modernatx.com.
First Quarter 2021 Financial Results
- Revenue: Total revenue was $1.9 billion for the three
months ended March 31, 2021 compared to $8 million for the same
period in 2020. Total revenue increased in the first quarter of
2021, resulting from a full quarter of commercial sales of the
Company’s COVID-19 vaccine in the U.S. and an initial ramp up of
international sales. A total of 102 million doses were recognized
as revenue. Product sales were $1.7 billion for the three months
ended March 31, 2021 from sales of the Company’s COVID-19 vaccine.
The increase in grant revenue of $190 million was primarily driven
by an increase in revenue from BARDA related to the Company’s
COVID-19 vaccine development.
- Cost of Sales: Costs of sales were $193 million, or 11%,
of product sales the three months ended March 31, 2021, including
third-party royalties of $84 million. A portion of the inventory
costs associated with the Company’s products sales for the three
months ended March 31, 2021 was expensed as pre-launch inventory
costs in 2020. If inventory sold in the three months ended March
31, 2021 was valued at cost, the Company’s cost of sales for the
quarter would have been $377 million, or 22% of product sales.
- Research and Development Expenses: Research and
development expenses were $401 million for the three months ended
March 31, 2021 compared to $115 million for the same period in
2020. The growth in spending was mainly due to increases in
clinical trial expenses, manufacturing expenses, personnel related
costs, and consulting and outside services, largely driven by
mRNA-1273 clinical development and increased headcount.
- Selling, General and Administrative Expenses: Selling,
general and administrative expenses were $77 million for the three
months ended March 31, 2021 compared to $24 million for the same
period in 2020. The growth in spending was mainly due to increases
in consulting and outside services, personnel-related costs, legal
and other licensing expenses, and marketing and other expenses,
primarily attributable to increased headcount and the Company’s
COVID-19 vaccine commercialization-related activities.
- Net Income (Loss): Net income was $1.2 billion for the
three months ended March 31, 2021 compared to a net loss of $(124)
million for the same period in 2020.
- Cash Position: Cash, cash equivalents and investments as
of March 31, 2021 and December 31, 2020 were $8.2 billion and $5.2
billion, respectively.
- Net Cash Provided by (Used in) Operating Activities: Net
cash provided by operating activities was $3.0 billion for the
three months ended March 31, 2021 compared to $(106) million used
in operating activities for the same period in 2020. Net cash
provided by operating activities increased significantly in 2021,
mainly due to net income of $1.2 billion and additional customer
deposits received in the first quarter for supply of the Company’s
COVID-19 vaccine.
- Cash Used for Purchases of Property and Equipment: Cash
used for purchases of property and equipment was $35 million for
the three months ended March 31, 2021 compared to $6 million for
the same period in 2020.
2021 Updated Financial Framework
- Advance Purchase Agreements (APAs): The Company has
already signed APAs for scheduled delivery in 2021, for a total of
$19.2 billion in anticipated product sales, including sales already
recorded in the three months ended March 31, 2021.
- Q2 Delivered Doses: The Company expects doses delivered
in the second quarter 2021 to be in the range of 200-250 million
doses.
- Cost of Sales: Cost of sales as percentage of product
sales are expected to be approximately 20% for fiscal year
2021.
- 2021 Research & Development (R&D) and Selling,
General & Administrative (SG&A) Expenses: Expect
quarter over quarter cost increases in R&D and SG&A
expenses during 2021 as commercial and research and development
activities and expenses ramp up.
- Tax Rate: Effective tax rate expected in the low-teens
as a result of the forecasted global sales mix and utilization of
the accumulated net operating loss carry-forward of $2.3 billion,
based on current tax rates.
- Capital Expenditures: $450-550 million of capital
investments currently planned for 2021 including the planned
capacity expansion.
2022 and 2023 Vaccine Access Discussions
- The Company has already signed APAs with Israel and Switzerland
for 2022, and Switzerland has options for further deliveries in
2023. Through its recent agreement with COVAX, the Company has
committed up to 466 million doses to COVAX for 2022. The Company is
having ongoing discussions for 2022 APAs with all governments that
have 2021 APAs. The Company is also having ongoing discussions to
supply new geographies in Asia, Latin America and Africa in 2022
that it could not supply in 2021 due to manufacturing supply
constraints. In response to feedback from governments for their
desire to procure more high efficacy mRNA vaccines, the Company
recently announced manufacturing investments to facilitate supply
of up to 3 billion doses in 2022. The Company is also engaged in
discussions with some governments for supply in 2023.
Management Updates
- Shannon Thyme Klinger will join the Company as Chief Legal
Officer and Corporate Secretary, effective June 1, 2021. Ms.
Klinger joins Moderna from Novartis (NYSE: NVS), where she served
as Chief Legal Officer and a member of the Novartis Executive
Committee since 2018. Previously, she served as Chief Ethics, Risk
& Compliance Officer. During her ten-year tenure at Novartis,
she held other roles of increasing responsibility, including as
Chief Ethics and Compliance Officer and Global Head of Litigation,
General Counsel and Global Head of Legal at Sandoz, a Novartis
division.
Corporate Updates
- Full-Time Employees: Over the last year, the Company
nearly doubled the size of its workforce. As of March 31, 2021,
Moderna had approximately 1,500 employees, compared to
approximately 830 employees as of March 31, 2020.
- Vaccines Day: Moderna hosted its annual Vaccines Day on
April 14, 2021.
- Corporate Social Responsibility (CSR): Moderna CEO
Stéphane Bancel published a letter on the Company’s commitment to
CSR on April 27, 2021.
- Company Recognition: Moderna was named as a top company
on Fast Company’s annual list of the World’s Most Innovative
Companies for 2021 and was named to TIME’s inaugural list of the
TIME100 Most Influential Companies.
Key 2021 Investor and Analyst Event Dates
- Science Day – May 27
- R&D Day – September 9
Investor Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00
a.m. ET on Thursday, May 5, 2021. To access the live conference
call, please dial 866-922-5184 (domestic) or 409-937-8950
(international) and refer to conference ID 7487119. A webcast of
the call will also be available under “Events and Presentations” in
the Investors section of the Moderna website at
investors.modernatx.com. The archived webcast will be available on
Moderna’s website approximately two hours after the conference call
and will be available for one year following the call.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. Moderna’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing the Company the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases, cardiovascular diseases, and
autoimmune and inflammatory diseases, independently and with
strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca PLC
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense; the Biomedical Advanced Research and Development Authority
(BARDA), a division of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS) and the Coalition for Epidemic
Preparedness Innovations (CEPI). Moderna has been named a top
biopharmaceutical employer by Science for the past six years. To
learn more, visit www.modernatx.com.
MODERNA, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited, in
millions, except per share data)
Three Months Ended March
31,
2021
2020
Revenue:
Product sales
$
1,733
$
—
Grant revenue
194
4
Collaboration revenue
10
4
Total revenue
1,937
8
Operating expenses:
Cost of sales
193
—
Research and development
401
115
Selling, general and administrative
77
24
Total operating expenses
671
139
Income (loss) from operations
1,266
(131)
Interest income
4
8
Other expense, net
(10)
(1)
Income (loss) before income taxes
1,260
(124)
Provision for income taxes
39
—
Net income (loss)
$
1,221
$
(124)
Earnings per share
Basic
$
3.05
$
(0.35)
Diluted
$
2.84
$
(0.35)
Weighted average common shares used in
calculation of earnings per share
Basic
400
353
Diluted
430
353
MODERNA, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA
(Unaudited, in millions)
March 31,
December 31,
2021
2020
Cash, cash equivalents and investments
$
8,203
$
5,247
Total assets
12,694
7,337
Total liabilities
8,856
4,776
Total stockholders’ equity
3,838
2,561
Total liabilities and stockholders’
equity
12,694
7,337
Three Months Ended March
31,
2021
2020
Net cash provided by (used in) operating
activities
$
2,971
$
(106)
Cash used for purchases of property and
equipment
(35)
(6)
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including statements regarding: the Company’s
development of the Moderna COVID-19 Vaccine (mRNA-1273); the number
of doses of the Moderna COVID-19 Vaccine that the Company
anticipates being able to manufacture in 2021 and 2022 and on a
quarterly basis, and investments to facilitate that manufacturing;
the Company’s efforts to continue developing vaccines against
COVID-19, including efforts to develop vaccines against variant
strains of SARS-CoV-2 and for booster doses, and the anticipated
efficacy of those vaccines; the Company’s plans to submit for a
Biologics License Application for mRNA-1273; the Company’s plans to
share additional data regarding its COVE Study of the Moderna
COVID-19 Vaccine and the conduct of ongoing and future clinical
trials; the development of additional COVID-19 vaccine candidates
that may be refrigerator stable; the conditions under which
mRNA-1273 or future vaccine candidates can be shipped and stored;
the efficacy of mRNA vaccines and their potential for regulatory
approval or authorization; the ability of the Moderna COVID-19
Vaccine to provide protection against COVID-19 over time; the
Company’s investments in increased research and development for
infectious diseases and other therapeutic areas; the potential
efficacy of vaccines against RSV and CMV and future clinical trials
for those vaccines; the status of developments for programs in the
Company’s pipeline, including with respect to the timing,
enrollment and potential results of clinical trials; future growth
prospects for the Company; the Company’s commercial rights to its
development candidates; future research and development expenses;
future sales, general and administrative expenses, and capital
expenditures, as well as other expenses; orders for the Company’s
Moderna COVID-19 Vaccine, both inside and outside the U.S.;
anticipated doses to be delivered under advance purchase agreement
in 2021 and 2022 and the associated dollar amounts to be received,
which should not be construed as expected 2021 or 2022 revenue; the
anticipated cost of sales associated with the Moderna COVID-19
Vaccine; the Company’s future tax rate; and personnel recruitment
efforts. In some cases, forward-looking statements can be
identified by terminology such as “will,” “may,” “should,” “could,”
“expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue,” or the negative
of these terms or other comparable terminology, although not all
forward-looking statements contain these words. The forward-looking
statements in this press release 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,
among others: the fact that there has never been a commercial
product utilizing mRNA technology approved for use; the fact that
the rapid response technology in use by Moderna is still being
developed and implemented; the safety, tolerability and efficacy
profile of the Moderna COVID-19 Vaccine observed to date may change
adversely in ongoing analyses of trial data or subsequent to
commercialization; the Moderna COVID-19 Vaccine may prove less
effective against variants of the SARS-CoV-2 virus, or the Company
may be unsuccessful in developing future versions of its vaccine
against these variants; despite having ongoing interactions with
the FDA or other regulatory agencies, the FDA or such other
regulatory agencies may not agree with the Company’s regulatory
approval strategies, components of our filings, such as clinical
trial designs, conduct and methodologies, or the sufficiency of
data submitted; Moderna may encounter delays in meeting
manufacturing or supply timelines or disruptions in its
distribution plans for the Moderna COVID-19 Vaccine; whether and
when any biologics license applications and/or additional emergency
use authorization applications may be filed in various
jurisdictions and ultimately approved by regulatory authorities;
potential adverse impacts due to the global COVID-19 pandemic such
as delays in regulatory review, manufacturing and clinical trials,
supply chain interruptions, adverse effects on healthcare systems
and disruption of the global economy; and those other risks and
uncertainties described under the heading “Risk Factors” in
Moderna’s most recent Annual Report on Form 10-K 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 press release 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 hereof.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210506005630/en/
Moderna Contacts
Media: Colleen Hussey Director, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President &
Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
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