Ended quarter with $3.1 billion in cash, cash
equivalents and investments
Moderna has received approximately $400 million
of customer deposits as of July 31, 2020 for potential supply of
mRNA-1273
Moderna updates 2020 guidance to reflect
investments into mRNA-1273; the Company now expects net cash used
in operating activities and for purchases of property and equipment
to be between $0.65 to $0.85 billion, including the benefit of
customer deposits received as of July 31, 2020
Phase 3 study of mRNA-1273 being conducted in
collaboration with NIH and BARDA on track to complete enrollment in
September 2020
Positive 12-month interim results after third
and final dose from Phase 1 study of CMV vaccine candidate
(mRNA-1647) study
Safety and immunogenicity data for all dose
cohorts of Phase 1 study of Zika vaccine candidate (mRNA-1893)
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines to create a new
generation of transformative medicines for patients, today reported
financial results and provided business updates for the second
quarter of 2020 and highlighted pipeline progress.
“The second quarter marked a new growth phase for Moderna as we
started to build our commercial team, a historic moment for those
of us who have worked at the company for many years since it was a
breakthrough research enterprise. We would like to thank the entire
Moderna team for their commitment to our mission of delivering on a
new class of medicines for patients,” said Stéphane Bancel,
Moderna’s Chief Executive Officer. “In the second quarter, we began
discussions with several countries for supply agreements for
mRNA-1273 and as of July 31, we have received approximately $400
million of customer deposits for potential supply. As we pivot to a
commercial stage company, we recognize the need for responsible
pricing in the face of the pandemic. We look forward to continuing
our progress as we prepare for the Phase 3 readout and the expected
subsequent filing of our BLA.”
New updates and recent progress include:
Infectious Diseases
- Phase 2 study of COVID-19 vaccine candidate (mRNA-1273) fully
enrolled; Phase 3 study of 30,000 volunteers in the U.S. being
conducted with NIH and BARDA began on July 27, on track to complete
enrollment in September, 2020; interim analysis of NIH-led Phase 1
study published in NEJM, results from non-human primate preclinical
viral challenge study published in NEJM
- Positive 12-month interim results from Phase 1 CMV vaccine
candidate (mRNA-1647) study
- Positive interim results from Phase 1 Zika vaccine candidate
(mRNA-1893) study
Oncology
- Data from the ongoing Phase 1 study of OX40L/IL-23/IL-36γ
(Triplet) (mRNA-2752) as a monotherapy and in combination with
durvalumab presented at the 2020 American Society of Clinical
Oncology (ASCO) Annual Meeting
Rare Diseases
- Phase 1 study evaluating escalating doses of antibody against
the chikungunya virus (mRNA-1944) administered via intravenous
infusion in healthy adults restarted after COVID-19
disruptions
- Due to COVID-19, enrollment and new site initiation continue to
be paused for methylmalonic acidemia (MMA; mRNA-3704) and propionic
acidemia (PA; mRNA-3927) clinical trials. During the pause, the
Company is implementing changes that the Company believes will
ultimately help to accelerate clinical development.
Moderna currently has 23 mRNA development candidates in its
portfolio with 13 in clinical studies. Across Moderna’s pipeline,
more than 2,000 healthy volunteers and patients have been enrolled
in clinical studies prior to enrolling the Phase 3 study of
mRNA-1273. The Company’s updated pipeline can be found at
www.modernatx.com/pipeline. Moderna and collaborators have
published more than 50 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.
Infections transmitted from mother to baby
- Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive data
from the 12-month interim analysis (six months after the third and
final vaccination) of the 30, 90 and 180 µg dose levels in the
Phase 1 study assessing the safety, reactogenicity, and
immunogenicity of different dose levels of mRNA-1647 are now
available. In both seronegative and seropositive participants,
durable neutralizing antibody responses were observed. In
seronegative participants at 12 months, neutralizing antibody
titers against epithelial cell infection at the 90 μg and 180 μg
doses were 3.6-fold and 3.9-fold higher than CMV-seropositive
baseline titers. In addition, seven-month interim safety data from
the 300 µg dose level after the third and final vaccination show
solicited adverse reactions increased with the higher dose and were
higher in seropositive participants. The most commonly reported
adverse events were pain at the injection site, headache, fatigue,
myalgia and chills for seronegative participants, with fever and
arthralgia as more common adverse events in seropositive
participants. At the 300 µg dose there continue to be no serious
adverse events reported. Despite COVID-19 disruptions, the Company
expects that it is on track for an interim data readout from the
Phase 2 study expected in the third quarter of 2020. Manufacturing
and planning are underway for the pivotal Phase 3 study, which is
designed to evaluate the efficacy of mRNA-1647 against primary CMV
infection in women of childbearing age and is expected to start in
2021. Additional feedback from regulators following meetings at the
conclusion of the Phase 2 study will help further inform the
clinical development plan and the trial protocol for the Phase 3
study. Moderna owns worldwide commercial rights for mRNA-1647.
- Zika virus vaccine (mRNA-1893): All dose cohorts (10,
30, 100 and 250 µg) in the Phase 1 study of mRNA-1893 have
completed enrollment. Positive data from an interim analysis are
now available for the 100 µg and 250 µg dose cohorts after the
second vaccination (Day 57). Interim data show all dose levels
induce a strong neutralizing ZIKV-specific antibody response in
both flavivirus infection naive (seronegative) participants and in
participants with pre-existing flavivirus antibodies
(seropositive). Notably, 100% seroconversion of baseline
seronegative participants was observed after the 2-dose series at
both the 100 μg dose level and the 250 μg dose level. Both the 100
µg and 250 µg dose levels were generally well-tolerated. There was
a trend towards more observations of local erythema and
swelling/induration at the injection site with higher dose levels
after the second vaccine administration, as well as a trend of more
solicited systemic adverse events with the 250 µg dose after the
second administration. In April 2020, Moderna announced positive
interim Phase 1 data showing the 10 µg and 30 µg dose levels of
mRNA-1893 induced a neutralizing antibody response in both
seronegative and seropositive participants and were generally
well-tolerated, with no vaccine-related serious adverse events
(SAEs) or adverse events of special interest (AESI). mRNA-1893 is
being developed in collaboration with the U.S. Biomedical Advanced
Research and Development Authority (BARDA) within the Office of the
Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services. Moderna owns worldwide
commercial rights to mRNA-1893.
Vaccines against respiratory infections
- COVID-19 vaccine (mRNA-1273): The Phase 3 COVE study,
being conducted in collaboration with the NIH and BARDA, began on
July 27; enrollment is on track to complete in September. The
Company will provide an update when enrollment is complete. Results
from a non-human primate preclinical viral challenge study
evaluating mRNA-1273 were recently published in The New England
Journal of Medicine and showed a two-dose vaccination schedule of
mRNA-1273 led to rapid protection against SARS-CoV-2 infection in
both the lungs and nose of non-human primates, without evidence of
vaccine-associated enhanced respiratory disease (VAERD). On July
14, an interim analysis of the original cohorts in the NIH-led
Phase 1 study evaluating a two-dose vaccination schedule of
mRNA-1273 across three dose levels (25, 100, 250 µg) in 45 healthy
adults ages 18-55 years was published in The New England Journal of
Medicine and shows mRNA-1273 induced rapid and strong immune
responses against SARS-CoV-2. mRNA-1273 was generally safe and well
tolerated with no serious adverse events reported through Day 57.
On May 29, the first participants in each age cohort: healthy
adults ages 18-55 years (n=300) and older adults ages 55 years and
above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July
8, the Phase 2 study completed enrollment. The Biomedical Advanced
Research and Development Authority (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 mRNA-1273 with federal
funding under Contract no. 75A50120C00034. A summary of the
company’s work to date on COVID-19 can be found here.
- Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3)
vaccine (mRNA-1653): Due to the pandemic, the Company
previously decided to pause new enrollment of participants in the
ongoing hMPV/PIV3 study (mRNA-1653), which had been actively
enrolling seropositive pediatric participants (12-36 months of
age). The Company intends to work with appropriate medical and site
personnel to determine when to resume new enrollment. Moderna owns
worldwide commercial rights to mRNA-1653.
- Pediatric respiratory syncytial virus (RSV) vaccine
(mRNA-1345): mRNA-1345 is a vaccine against RSV in young
children encoding for a prefusion F glycoprotein, which elicits a
superior neutralizing antibody response compared to the postfusion
state. The Company intends to combine mRNA-1345 with mRNA-1653, its
vaccine against hMPV and PIV3, to create a combination vaccine
against RSV, hMPV and PIV3. There is no approved vaccine for RSV.
Moderna owns worldwide commercial rights to the combined
mRNA-1345/mRNA-1653 vaccine.
- RSV vaccine (mRNA-1172 or V172): The Phase 1 study of
mRNA-1172 led by Merck is ongoing. Moderna has licensed worldwide
commercial rights to mRNA-1172 to Merck.
- Influenza H7N9 vaccine (mRNA-1851): Discussions
regarding funding the Company’s influenza H7N9 vaccine program
through approval are ongoing.
Vaccines against highly prevalent viral infections
- 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. There is no approved vaccine for EBV. Moderna
owns worldwide commercial rights to mRNA-1189.
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): The
Phase 1 study evaluating escalating doses of mRNA-1944 administered
via intravenous infusion in healthy adults has restarted after
COVID-19 disruptions. Both cohorts, one cohort at the 0.6 mg/kg
dose with steroid premedication and one cohort with two doses of
0.3 mg/kg (without steroid premedication) given one week apart, are
fully enrolled and all participants have been dosed.
- IL-2 (mRNA-6231): mRNA-6231 is an mRNA encoding for a
long-acting tolerizing IL-2. This new 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 new 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): Partnered with AstraZeneca, AZD7970
is in preclinical development for the treatment of heart failure.
Under the terms of the collaboration, AstraZeneca would sponsor the
Phase 1 trial to assess safety, tolerability and duration of
systemic exposure to the Relaxin protein. Moderna shares worldwide
commercial rights to AZD7970 with AstraZeneca.
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. The Phase 1 study is ongoing. 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 now actively recruiting.
The Company is evaluating the impact of COVID-19-related challenges
that are leading to delays in enrollment. 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. Data from the Phase 1 study of mRNA-2752 alone
and in combination with durvalumab were presented at the 2020
American Society of Clinical Oncology (ASCO) Annual Meeting and
support the ongoing testing of the mRNA-2752/durvalumab
combination. 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.
- Methylmalonic acidemia (MMA) (mRNA-3704): Due to the
COVID-19 pandemic, Moderna previously decided to pause new
enrollment and new site initiation for its Phase 1/2 study of
mRNA-3704 to ensure the safety of these pediatric patients and
their caregivers. No patients have been dosed to date. During the
pause, the Company is implementing changes that the Company
believes will ultimately help to accelerate clinical development.
mRNA-3704 uses the same LNP formulation as mRNA-1944. Moderna owns
worldwide commercial rights to mRNA-3704.
- Propionic acidemia (PA) (mRNA-3927): Due to the COVID-19
pandemic, Moderna previously decided to pause new enrollment and
new site initiation for its Phase 1/2 study of mRNA-3927 to ensure
the safety of these pediatric patients and their caregivers. No
patients have been dosed to date. During the pause, the Company is
implementing changes that the Company believes will ultimately help
to accelerate clinical development. mRNA-3927 uses the same LNP
formulation as mRNA-1944. Moderna owns worldwide commercial rights
to mRNA-3927.
- MMA and PA Natural History Study (MaP): This is a
global, multi-center, non-interventional study for patients with
confirmed diagnosis of MMA due to MUT deficiency or PA and is
designed to identify and correlate clinical and biomarker endpoints
for these disorders. Enrollment in the study has been
completed.
- 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, including those discussed in this press release, can be
found on the investor relations page of its website:
investors.modernatx.com.
Management Updates
- David Meline joined Moderna as Chief Financial Officer on June
4. Mr. Meline previously served as Chief Financial Officer and EVP
at Amgen (Nasdaq: AMGN) from 2014 through 2019. Prior to Amgen, Mr.
Meline spent six years at 3M Company (NYSE: MMM), where he most
recently served as CFO and Senior Vice President and was
responsible for all 3M financial activities across 70 countries of
operation.
- Ray Jordan joined Moderna as Chief Corporate Affairs Officer on
June 15. Mr. Jordan served as Senior Vice President, Corporate
Affairs at Amgen (Nasdaq: AMGN) from 2012 through 2019. Prior to
Amgen, Mr. Jordan spent nine years at Johnson & Johnson (NYSE:
JNJ), where he led corporate communications and public affairs for
more than 250 operating companies in 60 countries.
Corporate Updates
- In May 2020, the Company raised approximately $1.30 billion in
net proceeds through a public equity offering.
- The Company was added to the MSCI US Equity Indexes on May 29,
2020.
- The Company joined the NASDAQ-100 Index on July 20, 2020.
Financial Guidance
- The Company ended the quarter with $3.1 billion in cash, cash
equivalents and investments.
- Moderna updates 2020 guidance to reflect investments into
mRNA-1273, the Company now expects net cash used in operating
activities and for purchases of property and equipment to be
between $0.65 to $0.85 billion; this includes approximately $400
million of customer deposits received as of July 31, 2020 for
potential supply of mRNA-1273.
- The increase in expected investment levels is primarily driven
by the supply network expansion both in the U.S. and outside the
U.S.
Key 2020 Investor and Analyst Event Dates
- R&D Day – September 17 (virtual)
Second Quarter 2020 Financial Results (Unaudited)
- Cash Position: Cash, cash equivalents and investments as
of June 30, 2020 and December 31, 2019 were $3.07 billion and $1.26
billion, respectively.
- Net Cash Used in Operating Activities: Net cash used in
operating activities was $130.1 million for the six months ended
June 30, 2020 compared to $252.9 million for the same period in
2019. Net cash used in operating activities decreased significantly
in 2020 mainly due to an increase in deferred revenue attributable
to deposits of $75.0 million received in the second quarter of 2020
for potential supply of mRNA-1273. Net cash used in operating
activities includes $22.0 million for the six months ended June 30,
2019, of in-licensing payments to Cellscript, LLC to sublicense
certain patent rights.
- Cash Used for Purchases of Property and Equipment: Cash
used for purchases of property and equipment was $24.9 million for
the six months ended June 30, 2020 compared to $18.2 million for
the same period in 2019.
- Revenue: Total revenue was $66.4 million for the three
months ended June 30, 2020 compared to $13.1 million for the same
period in 2019. Total revenue was $74.7 million for the six months
ended June 30, 2020 compared to $29.1 million for the same period
in 2019. Total revenue increased for both three and six month
periods in 2020, due to increases in both collaboration revenue and
grant revenue. The collaboration revenue increases in both three
and six month periods were mainly attributable to an increase in
revenue in the second quarter, particularly from AstraZeneca. The
increases in grant revenue for both periods were primarily due to
our BARDA agreement, related to our mRNA-1273 vaccine candidate
development.
- Research and Development Expenses: Research and
development expenses were $151.9 million for the three months ended
June 30, 2020 compared to $128.3 million for the same period in
2019. Research and development expenses were $267.0 million for the
six months ended June 30, 2020 compared to $258.7 million for the
same period in 2019. The increases for both three and six month
periods in 2020 were mainly due to increases in personnel related
costs, an increase in consulting and outside services, and an
increase in stock compensation expenses, largely driven by
increased headcount and mRNA-1273 clinical development.
- General and Administrative Expenses: General and
administrative expenses were $36.6 million for the three months
ended June 30, 2020 compared to $28.5 million for the same period
in 2019. General and administrative expenses were $60.7 million for
the six months ended June 30, 2020 compared to $55.7 million for
the same period in 2019. The increases for both three and six month
periods in 2020 were mainly due to an increase in personnel related
costs and an increase in legal related costs, primarily
attributable to increased headcount and mRNA-1273 vaccine candidate
development related activities.
- Net Loss: Net loss was $116.7 million for the three
months ended June 30, 2020 compared to $134.9 million for the same
period in 2019. Net loss was $240.9 million for the six months
ended June 30, 2020 compared to $267.5 million for the same period
in 2019.
Investor Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00
a.m. ET on Wednesday, August 5, 2020. To access the live conference
call, please dial 866-922-5184 (domestic) or 409-937-8950
(international) and refer to conference ID 2673189. 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. A replay of the webcast will be archived
on Moderna’s website for one year following the presentation.
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 five years. To
learn more, visit www.modernatx.com.
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
expectations regarding net cash used in operating activities and
for purchases of property and equipment, expected timing of
enrollment completion for the Phase 3 study of mRNA-1273, the
timing of a potential BLA approval for mRNA-1273; the timing of
interim results from the Phase 2 study of mRNA-1647; the timing and
design of the Phase 3 study of mRNA-1647; the Company’s intention
to create a combination therapy with mRNA-1345 and mRNA-1653
against RSV, hMPV and PIV3; the Company’s intention regarding a
Phase 1 study of mRNA-6981 in type 1 autoimmune hepatitis; the
timing and status of the Phase 1 study of mRNA-6231 in healthy
volunteers; the Company’s intentions regarding resumption of
enrollment and the implementation of changes for paused clinical
studies; the probability of success of the Company’s vaccines
individually and as a portfolio; and the ability of the Company to
accelerate the research and development timeline for any individual
product or the platform as a whole. 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: preclinical and clinical
development is lengthy and uncertain, especially for a new class of
medicines such as mRNA, and therefore our preclinical programs or
development candidates may be delayed, terminated, or may never
advance to or in the clinic; no commercial product using mRNA
technology has been approved and may never be approved; mRNA drug
development has substantial clinical development and regulatory
risks due to the novel and unprecedented nature of this new class
of medicines; 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; the fact that the rapid response technology in use by
Moderna is still being developed and implemented; the fact that the
safety and efficacy of mRNA-1273 has not yet been established;
potential adverse impacts due to the global COVID-19 pandemic such
as delays in clinical trials, preclinical work, overall operations,
regulatory review, manufacturing and supply chain interruptions,
adverse effects on healthcare systems and disruption of the global
economy; and those risks and uncertainties described under the
heading “Risk Factors” in Moderna’s most recent Quarterly Report on
Form 10-Q 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.
MODERNA, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited, in thousands,
except share and per share data)
Three Months Ended June
30,
Six Months Ended June
30,
2020
2019
2020
2019
Revenue:
Collaboration revenue
$
28,442
$
10,030
$
32,899
$
24,145
Grant revenue
37,909
3,053
41,841
4,963
Total revenue
66,351
13,083
74,740
29,108
Operating expenses:
Research and development
151,856
128,305
266,993
258,718
General and administrative
36,622
28,487
60,736
55,740
Total operating expenses
188,478
156,792
327,729
314,458
Loss from operations
(122,127)
(143,709)
(252,989)
(285,350)
Interest income
7,092
10,322
14,944
21,294
Other expense, net
(1,530)
(1,877)
(2,684)
(3,808)
Loss before income taxes
(116,565)
(135,264)
(240,729)
(267,864)
Provision for (benefit from) income
taxes
148
(324)
214
(348)
Net loss
$
(116,713)
$
(134,940)
$
(240,943)
$
(267,516)
Net loss per share, basic and diluted
$
(0.31)
$
(0.41)
$
(0.66)
$
(0.81)
Weighted average common shares used in net
loss per share, basic and diluted
380,531,488
329,176,107
366,818,254
328,994,058
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS AND STATEMENTS OF CASH FLOWS DATA
(Unaudited, in
thousands)
June 30,
December 31,
2020
2019
Cash, cash equivalents and investments
$
3,071,929
$
1,262,987
Total assets
3,486,006
1,589,422
Total liabilities
539,121
414,612
Total stockholders’ equity
2,946,885
1,174,810
Total liabilities and stockholders’
equity
3,486,006
1,589,422
Six Months Ended June
30,
2020
2019
Net cash used in operating activities
$
130,066
$
252,853
Cash used for purchases of property and
equipment
24,855
18,181
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200805005476/en/
Moderna
Media: Colleen Hussey Senior Manager, Corporate
Communications 617-335-1374 Colleen.Hussey@modernatx.com
Dan Budwick 1AB 973-271-6085 Dan@1abmedia.com
Investors:
Lavina Talukdar Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
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