Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision
genetic medicine for rare diseases, today reported financial
results for the three months ended March 31, 2019.
“Having built out our multi-platform portfolio
of genetic medicine in the prior two years and set out our ambition
for Sarepta, we stated at the commencement of 2019 that this would
be a year of execution. While we have much left to accomplish in
2019, I am pleased to report and quite proud that the Sarepta team
executed brilliantly in the first quarter,” stated Doug Ingram,
Sarepta’s president and chief executive officer.
Mr. Ingram continued, “Our Q1 2019 and recent
accomplishments include the following: we continued to deliver on
Exondys 51 and serve the Duchenne community; having fulfilled our
commitment to commence our clinical process placebo-controlled
trial for our micro-dystrophin gene therapy program by the fourth
quarter of 2018, we made great progress on enrollment and dosing
and are on track to complete dosing in the second quarter; we
announced impressive results for our first LGMD2E cohort,
particularly encouraging when one considers that the dose was one
quarter of our micro-dystrophin program, reflecting the elegance of
our construct and the potential for read through to other programs;
fulfilling our promise to build a positive, science-driven
relationship with the FDA and define an accelerated approval
pathway for our RNA technology, the FDA accepted for filing our
golodirsen package, informed us there would be no advisory
committee at this time, and gave us priority review; we announced
positive results for our third RNA program for casimersen; and we
advanced our gene therapy manufacturing platform, moving to the
late stage process development for our micro-dystrophin program,
securing a dedicated 75,000 square foot manufacturing facility with
Brammer, which we plan to be operational in 2019, and are working
with Paragon and Catalent to deepen our relationship and create,
either through a joint venture or otherwise, a second dedicated
gene therapy facility. And beyond that, we continue to build our
vision as an enduring genetic medicine leader; today we announced a
new partnership with Nationwide Children’s Hospital to advance a
gene therapy treatment for LGMD2A, the most common type of LGMD, a
program perfectly aligned with our strategy to build out an
enduring multi-therapeutic gene therapy engine.”
First Quarter 2019 and Recent Corporate
Developments
- Agreement with Nationwide Children’s Hospital for
Rights to its Gene Therapy Program to Treat Limb Girdle Muscular
Dystrophy Type 2A (May 8, 2019): Sarepta announced
an agreement with the Research Institute at Nationwide Children’s
for the exclusive option to gene therapy candidate, calpain 3
(CAPN-3), to treat Limb-girdle muscular dystrophy type 2A (LGMD2A)
also known as calpainopathy. LGMD2A is caused by mutations in the
CAPN-3 gene and is the most common type of LGMD, accounting for
almost a third of cases. Like Sarepta’s micro-dystrophin and five
other LGMD programs, the LGMD2A program employs the AAVrh74 vector,
designed to systematically and robustly deliver treatment to
skeletal muscle, including the diaphragm, without promiscuously
crossing the blood brain barrier, making it an ideal candidate to
treat muscle disease. The CAPN-3 program is currently in
pre-clinical trials and is led by Zarife Sahenk, M.D., Ph.D., an
attending neurologist at Nationwide Children's, Director of
Clinical and Experimental Neuromuscular Pathology at The Research
Institute at Nationwide Children's and Professor of Pediatrics,
Pathology and Neurology at The Ohio State University College of
Medicine.
- LGMD2E Clinical Data Accepted for Late-breaking Oral
Presentation at the 2019 MDA Clinical and Scientific Conference
(April 8, 2019): Sarepta’s positive clinical data
from the Company’s Limb-girdle muscular dystrophy (LGMD) Type 2E
gene therapy program was accepted as a late-breaker oral
presentation at the Muscular Dystrophy Association (MDA) Clinical
and Scientific Conference in Orlando, Fla. Louise Rodino-Klapac,
Ph.D., Sarepta’s Senior Vice President of Gene Therapy, presented.
In addition to the late-breaking oral presentation, six posters
highlighting data from Sarepta’s RNA and gene therapy programs for
Duchenne muscular dystrophy (DMD) and LGMD2D were also presented.
In the LGMD2E study, two patients had elevated liver enzymes, one
of which was designated a serious adverse event (SAE), as the
patient had associated transient increase in bilirubin. These
events occurred as patient tapered off oral steroids. Following
supplemental steroid treatment, both patients returned to baseline
and symptoms resolved within days. No other clinically significant
laboratory findings or decreases in platelet counts were
observed.
- Positive Expression Results from the Casimersen
(SRP-4045) Arm of the ESSENCE Study (March 28, 2019):
Sarepta announced results of its interim analysis of muscle biopsy
endpoints comparing casimersen treatment to placebo in the ESSENCE
study, also known as study 4045-301. Patients amenable to exon 45
skipping were randomized to receive a once-weekly intravenous (IV)
infusion of casimersen dosed at 30mg/kg (N=27) or placebo (N=16)
for 96 weeks. The interim analysis was performed on data from
biopsies of the bicep muscle at baseline and on-treatment at Week
48. In the casimersen arm, mean dystrophin protein (% normal
dystrophin as measured by western blot) increased to 1.736% of
normal compared to a mean baseline of 0.925% of normal
(p<0.001). A statistically significant difference in the mean
change from baseline to week 48 in dystrophin protein was observed
between the casimersen-treated arm compared to the placebo arm
(p=0.009). Of the 22 patients receiving casimersen who have been
tested for increased exon-skipping mRNA using reverse transcription
polymerase chain reaction (RT-PCR), all have displayed an increase
in skipping exon 45 (p<0.001) over their baseline levels,
representing a 100% response rate. A statistically significant
positive correlation between exon 45 skipping and dystrophin
production was observed. The study is ongoing and remains blinded
to collect additional efficacy and safety data.
- Micro-dystrophin Study 101 Update
(March 25, 2019): On March 25,
2019, Sarepta held a conference call regarding encouraging 9-month
functional and creatine kinase (CK) data from baseline for the 4
patients in the Phase 1 open-label study of the Company’s
micro-dystrophin gene therapy candidate for Duchenne muscular
dystrophy.
Conference CallThe Company will
be hosting a conference call at 4:30 p.m. Eastern Time to discuss
Sarepta’s financial results and provide a corporate update. The
conference call may be accessed by dialing (844) 534-7313 for
domestic callers and (574) 990-1451 for international callers. The
passcode for the call is 5198075. Please specify to the operator
that you would like to join the “Sarepta First Quarter 2019
Earnings Call." The conference call will be webcast live under the
investor relations section of Sarepta's website at www.sarepta.com
and will be archived there following the call for 90 days. Please
connect to Sarepta's website several minutes prior to the start of
the broadcast to ensure adequate time for any software download
that may be necessary.
Financial Results
On a GAAP basis, the Company reported a net loss
of $76.6 million and $35.4 million, or $1.07 and $0.55 per basic
and diluted share for the first quarter of 2019 and 2018,
respectively. On a non-GAAP basis, the net loss for the first
quarter of 2019 was $53.8 million, or $0.75 per basic and diluted
share, compared to a net loss of $17.9 million for the same period
of 2018, or $0.28 per basic and diluted share.
Net Revenues
For the three months ended March 31, 2019, the
Company recorded net revenues of $87.0 million, compared to net
revenues of $64.6 million for the same period of 2018, an increase
of $22.4 million. The increases primarily reflect the continuing
increase in demand for EXONDYS 51 in the U.S.
Cost and Operating Expenses
Cost of sales (excluding amortization of
in-licensed rights)For the three months ended March 31, 2019, cost
of sales (excluding amortization of in-licensed rights) was $12.1
million, compared to $5.6 million for the same period of 2018. The
increase primarily reflects royalty payments to BioMarin
Pharmaceuticals (BioMarin) and higher product costs as a result of
increasing demand for EXONDYS 51, as well as an inventory write-off
related to certain batches of product not meeting the Company’s
quality specifications. Prior to the approval of EXONDYS 51, the
Company expensed related manufacturing and material costs as
research and development expenses. As a result, the Company sold
more product with no cost during the first quarter of 2018 compared
with the same period of 2019.
Research and developmentResearch and development
expenses were $90.6 million for the first quarter of 2019, compared
to $46.2 million for the same period of 2018, an increase of $44.4
million. The increase in research and development expenses
primarily reflects the following:
- $18.8 million increase in clinical and manufacturing expenses
primarily due to a ramp-up of manufacturing activities for our
micro-dystrophin program and initiation of certain post-marketing
studies for EXONDYS 51. The increases were partially offset by a
ramp-down of the PROMOVI trial in EXONDYS 51 and the Phase 1/2
trials in golodirsen;
- $11.4 million increase in compensation and other personnel
expenses primarily due to a net increase in headcount;
- $8.3 million increase in facility- and technology-related
expenses due to our continuing expansion efforts as well as change
in methodology in allocation of technology expense;
- $3.0 million increase in stock-based compensation expense
primarily driven by increases in headcount and stock price;
- $2.2 million increase in pre-clinical expenses primarily due to
the continuing ramp-up of toxicology studies in our PPMO
platform;
- $1.2 million increase in sponsored research with institutions
such as Nationwide Children’s Hospital; and
- $2.9 million decrease in collaboration cost sharing with Summit
as it is winding down activities on its Utrophin platform.
Non-GAAP research and development expenses were
$81.4 million and $43.3 million for the first quarter of 2019 and
2018, respectively, an increase of $38.1 million.
Selling, general and administrationSelling
general and administrative expenses were $60.6 million for the
first quarter of 2019, compared to $43.3 million for the same
period of 2018, an increase of $17.3 million. The increase in
selling, general and administrative expenses primarily reflects the
following:
- $10.4 million increase in compensation and other personnel
expenses primarily due to an increase in headcount;
- $3.2 million increase in facility- and technology-related
expense primarily due to continuing global expansion offset by a
decrease in technology expense due to a change in allocation
methodology; and
- $2.6 million increase in stock-based compensation primarily due
to increases in headcount and stock price.
Non-GAAP selling, general and administrative
expenses were $47.8 million and $33.7 million for the first quarter
of 2019 and 2018, respectively, an increase of $14.1 million.
Amortization of in-licensed rightsFor both the
three months ended March 31, 2019 and 2018, the Company recorded
amortization of in-licensed rights of approximately $0.2
million
Other loss
Interest expense and other, net
For the three months ended March 31, 2019 and
2018, the Company recorded $0.2 million and $4.5 million,
respectively, of interest expense and other, net. The decrease
primarily reflects increases in interest income from higher
balances of cash, cash equivalents and investments and amortization
of investment discount as a result of an increase in interest
rates.
Cash, Cash Equivalents,
Investments and Restricted
Cash and
Investments
The Company had approximately $1.4 billion in
cash, cash equivalents and investments as of March 31, 2019
compared to $1.0 billion as of March 31, 2018. The increase is
primarily driven by the proceeds of the public offering of common
stock in March 2019 offset by cash used to fund the Company’s
ongoing operations during the first quarter of 2019.
Use of Non-GAAP Measures
In addition to the GAAP financial measures set
forth in this press release, the Company has included certain
non-GAAP measurements. The non-GAAP loss is defined by the Company
as GAAP net loss excluding interest expense/(income), income tax
expense/(benefit), depreciation and amortization expense,
stock-based compensation expense and other items. Non-GAAP research
and development expenses are defined by the Company as GAAP
research and development expenses excluding depreciation and
amortization expense, stock-based compensation expense and other
items. Non-GAAP selling, general and administrative expenses are
defined by the Company as GAAP selling, general and administrative
expenses excluding depreciation and amortization expense,
stock-based compensation expense and other items.
1. Interest, tax, depreciation and
amortization
Interest income and expense amounts can vary
substantially from period to period due to changes in cash and debt
balances and interest rates driven by market conditions outside of
the Company’s operations. Tax amounts can vary substantially
from period to period due to tax adjustments that are not directly
related to underlying operating performance. Depreciation expense
can vary substantially from period to period as the purchases of
property and equipment may vary significantly from period to period
and without any direct correlation to the Company’s operating
performance. Amortization expense associated with in-licensed
rights as well as patent costs are amortized over a period of
several years after acquisition or patent application or renewal
and generally cannot be changed or influenced by management.
2. Stock-based compensation expenses
Stock-based compensation expenses represent
non-cash charges related to equity awards granted by Sarepta.
Although these are recurring charges to operations, management
believes the measurement of these amounts can vary substantially
from period to period and depend significantly on factors that are
not a direct consequence of operating performance that is within
management's control. Therefore, management believes that excluding
these charges facilitates comparisons of the Company’s operational
performance in different periods.
3. Other items
The Company evaluates other items of expense and
income on an individual basis. It takes into consideration
quantitative and qualitative characteristics of each item,
including (a) nature, (b) whether the items relate to the Company’s
ongoing business operations, and (c) whether the Company expects
the items to continue on a regular basis. These other items include
up-front and milestone payments. The Company excludes up-front and
milestone expenses associated with its license and collaboration
agreements from its financial results and research and development
expenses because the Company does not consider them to be normal
operating expenses due to their nature, variability of amounts, and
lack of predictability as to occurrence and/or timing. Up-front
payments are made at the commencement of a collaborative
relationship or a license agreement anticipated to continue for a
multi-year period and provide the Company with intellectual
property rights, option rights and other rights with respect to
particular programs. Milestone payments are made when certain
development, regulatory and sales milestone events are achieved.
The variability of amounts and lack of predictability of
collaboration- and license-related up-front and milestone payment
makes the identification of trends in the Company’s ongoing
research and development activities more difficult. The Company
believes the presentation of adjusted research and development,
which does not include license- and collaboration-related up-front
and milestone expenses, provides useful and meaningful information
about its ongoing research and development activities by enhancing
investors’ understanding of the Company’s normal, recurring
operating research and development expenses and facilitates
comparisons between periods and with respect to projected
performance.
The Company uses these non-GAAP measures as key
performance measures for the purpose of evaluating operational
performance and cash requirements internally. The Company also
believes these non-GAAP measures increase comparability of
period-to-period results and are useful to investors as they
provide a similar basis for evaluating the Company’s performance as
is applied by management. These non-GAAP measures are not intended
to be considered in isolation or to replace the presentation of the
Company’s financial results in accordance with GAAP. Use of the
terms non-GAAP research and development expenses, non-GAAP selling,
general and administrative expenses, non-GAAP other income and loss
adjustments, non-GAAP income tax expense, non-GAAP net loss, and
non-GAAP basic and diluted net loss per share may differ from
similar measures reported by other companies, which may limit
comparability, and are not based on any comprehensive set of
accounting rules or principles. All relevant non-GAAP measures are
reconciled from their respective GAAP measures in the attached
table "Reconciliation of GAAP Financial Measures to Non-GAAP
Financial Measures.”
About EXONDYS 51
EXONDYS 51 uses Sarepta’s proprietary
phosphorodiamidate morpholino oligomer (PMO) chemistry and
exon-skipping technology to skip exon 51 of the dystrophin gene.
EXONDYS 51 is designed to bind to exon 51 of dystrophin pre-mRNA,
resulting in exclusion of this exon during mRNA processing in
patients with genetic mutations that are amenable to exon 51
skipping. Exon skipping is intended to allow for production of an
internally truncated dystrophin protein.
Important Safety Information About
EXONDYS 51
Hypersensitivity reactions, including rash and
urticaria, pyrexia, flushing, cough, dyspnea, bronchospasm, and
hypotension, have occurred in patients who were treated with
EXONDYS 51. If a hypersensitivity reaction occurs, institute
appropriate medical treatment and consider slowing the infusion or
interrupting the EXONDYS 51 therapy.
Adverse reactions in DMD patients (N=8) treated
with EXONDYS 51 30 or 50 mg/kg/week by intravenous (IV) infusion
with an incidence of at least 25% more than placebo (N=4) (Study 1,
24 weeks) were (EXONDYS 51, placebo): balance disorder (38%, 0%),
vomiting (38%, 0%) and contact dermatitis (25%, 0%). The most
common adverse reactions were balance disorder and vomiting.
Because of the small numbers of patients, these represent crude
frequencies that may not reflect the frequencies observed in
practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is
not recommended.
In the 88 patients who received ≥30 mg/kg/week
of EXONDYS 51 for up to 208 weeks in clinical studies, the
following events were reported in ≥10% of patients and occurred
more frequently than on the same dose in Study 1: vomiting,
contusion, excoriation, arthralgia, rash, catheter site pain, and
upper respiratory tract infection.
For further information, please see the full
Prescribing Information.
About Sarepta Therapeutics Sarepta is at
the forefront of precision genetic medicine, having built an
impressive and competitive position in Duchenne muscular dystrophy
(DMD) and more recently in gene therapies for 6 Limb-girdle
muscular dystrophy diseases (LGMD), Charcot-Marie-Tooth (CMT), MPS
IIIA, Pompe and other CNS-related disorders, totaling over 20
therapies in various stages of development. The Company’s programs
and research focus span several therapeutic modalities, including
RNA, gene therapy and gene editing. Sarepta is fueled by an
audacious but important mission: to profoundly improve and extend
the lives of patients with rare genetic-based diseases. For more
information, please visit www.sarepta.com.
Forward-Looking Statements
In order to provide Sarepta’s investors with an
understanding of its current results and future prospects, this
press release contains statements that are forward-looking. Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Words such as “believes,” “anticipates,” “plans,” “expects,”
“will,” “may,” “intends,” “prepares,” “looks,” “potential,”
“possible” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements
include statements relating to Sarepta being on track to complete
dosing in our micro-dystrophin gene therapy program in the second
quarter of 2019; the potential for read through of our first LGMD
2E cohort results to other programs; our plan that the
manufacturing facility with Brammer be operational in 2019; our
plan to deepen our relationship with Paragon and Catalent and
create, either through a joint venture or otherwise, a second
dedicated gene therapy facility; our goal to build out an enduring
multi-therapeutic gene therapy engine; the AAVrh74 vector’s design
to systematically and robustly deliver treatment to skeletal
muscle, including the diaphragm, without promiscuously crossing the
blood brain barrier, making it an ideal candidate to treat muscle
disease; exon skipping’s design to allow for production of an
internally truncated dystrophin protein; and our mission to
profoundly improve and extend the lives of patients with rare
genetic-based diseases.
These forward-looking statements involve risks
and uncertainties, many of which are beyond Sarepta’s control.
Actual results could materially differ from those stated or implied
by these forward-looking statements as a result of such risks and
uncertainties. Known risk factors include the following: we may not
be able to meet expectations with respect to EXONDYS 51 sales or
attain the net revenues we anticipate for 2019, profitability or
positive cash-flow from operations; we may not be able to comply
with all FDA post-approval commitments and requirements with
respect to EXONDYS 51 in a timely manner or at all; the expected
benefits and opportunities related to the agreement with Nationwide
Children’s pertaining to CAPN-3 may not be realized or may take
longer to realize than expected due to challenges and uncertainties
inherent in product research and development; Sarepta’s dependence
on certain manufacturers to produce its product candidates,
including any inability on Sarepta’s part to accurately anticipate
product demand and timely secure manufacturing capacity to meet
product demand, may impair the availability of product to
successfully support various programs; success in preclinical
testing and early clinical trials, especially if based on a small
patient sample, does not ensure that later clinical trials will be
successful, and initial results from a clinical trial do not
necessarily predict final results; our data for golodirsen,
casimersen, SRP-9001, the LGMD programs and/or other programs may
not be sufficient for obtaining regulatory approval; if the actual
number of patients suffering from DMD, LGMD, pompe disease, CMT
and/or MPS IIIA is smaller than estimated, our revenue and ability
to achieve profitability may be adversely affected; Sarepta may not
be able to execute on its business plans, including meeting its
expected or planned regulatory milestones and timelines, research
and clinical development plans, and bringing its product candidates
to market, for various reasons, some of which may be outside of
Sarepta’s control, including possible limitations of company
financial and other resources, manufacturing limitations that may
not be anticipated or resolved for in a timely manner, and
regulatory, court or agency decisions, such as decisions by the
United States Patent and Trademark Office with respect to patents
that cover Sarepta’s product candidates; and those risks identified
under the heading “Risk Factors” in Sarepta’s most recent Annual
Report on Form 10-K for the year ended December 31, 2018 and most
recent Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) as well as other SEC filings made by the
Company which you are encouraged to review.
Any of the foregoing risks could materially and
adversely affect the Company’s business, results of operations and
the trading price of Sarepta’s common stock. You should not place
undue reliance on forward-looking statements. Sarepta does not
undertake any obligation to publicly update its forward-looking
statements based on events or circumstances after the date hereof,
except to the extent required by applicable law or SEC rules.
Internet Posting of
Information
We routinely post information that may be
important to investors in the 'For Investors' section of our
website at www.sarepta.com. We encourage investors and
potential investors to consult our website regularly for important
information about us.
|
|
Sarepta Therapeutics, Inc. |
|
Condensed Consolidated Statements of Operations |
|
(unaudited, in thousands, except per share amounts) |
|
|
|
|
For the Three Months EndedMarch
31, |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
Product, net |
$ |
87,011 |
|
|
$ |
64,604 |
|
Total revenues |
|
87,011 |
|
|
|
64,604 |
|
Cost and expenses: |
|
|
|
|
|
|
|
Cost of sales (excluding amortization of in-licensed
rights) |
|
12,063 |
|
|
|
5,582 |
|
Research and development |
|
90,553 |
|
|
|
46,204 |
|
Selling, general and administrative |
|
60,566 |
|
|
|
43,341 |
|
Amortization of in-licensed rights |
|
216 |
|
|
|
216 |
|
Total cost and expenses |
|
163,398 |
|
|
|
95,343 |
|
Operating loss |
|
(76,387 |
) |
|
|
(30,739 |
) |
Other loss: |
|
|
|
|
|
|
|
Interest expense and other, net |
|
(172 |
) |
|
|
(4,485 |
) |
Other loss |
|
(172 |
) |
|
|
(4,485 |
) |
|
|
|
|
|
|
|
|
Loss before income tax
expense |
|
(76,559 |
) |
|
|
(35,224 |
) |
Income tax expense |
|
84 |
|
|
|
139 |
|
Net loss |
$ |
(76,643 |
) |
|
$ |
(35,363 |
) |
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
$ |
(1.07 |
) |
|
$ |
(0.55 |
) |
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock used in computing basic and diluted
net loss per share |
|
71,731 |
|
|
|
64,631 |
|
|
|
|
|
|
|
|
|
|
|
Sarepta Therapeutics, Inc. |
|
Reconciliation of GAAP Financial Measures to Non-GAAP Financial
Measures |
|
(unaudited, in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
GAAP net loss |
$ |
(76,643 |
) |
|
$ |
(35,363 |
) |
Interest expense, net |
|
642 |
|
|
|
4,503 |
|
Income tax expense |
|
84 |
|
|
|
139 |
|
Depreciation and amortization expense |
|
4,880 |
|
|
|
2,252 |
|
Stock-based compensation expense |
|
16,139 |
|
|
|
10,526 |
|
Up-front and milestone payments |
|
1,122 |
|
|
|
— |
|
Non-GAAP net loss |
$ |
(53,776 |
) |
|
$ |
(17,943 |
) |
|
|
|
|
|
|
|
|
Non-GAAP net loss per
share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.75 |
) |
|
$ |
(0.28 |
) |
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock outstanding for computing: |
|
|
|
|
|
|
|
Basic and diluted |
|
71,731 |
|
|
|
64,631 |
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
GAAP research and development
expenses |
$ |
90,553 |
|
|
$ |
46,204 |
|
Up-front and milestone payments |
|
(1,122 |
) |
|
|
— |
|
Stock-based compensation expense |
|
(5,087 |
) |
|
|
(2,060 |
) |
Depreciation and amortization expense |
|
(2,962 |
) |
|
|
(848 |
) |
Non-GAAP research and
development expenses |
$ |
81,382 |
|
|
$ |
43,296 |
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
GAAP selling, general and
administrative expenses |
$ |
60,566 |
|
|
$ |
43,341 |
|
Stock-based compensation expense |
|
(11,052 |
) |
|
|
(8,466 |
) |
Depreciation and amortization expense |
|
(1,702 |
) |
|
|
(1,188 |
) |
Non-GAAP selling, general and
administrative expenses |
$ |
47,812 |
|
|
$ |
33,687 |
|
|
|
|
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Sarepta Therapeutics, Inc. |
|
Condensed Consolidated Balance Sheets |
|
(unaudited, in thousands, except share and per share data) |
|
|
|
|
As ofMarch
31,2019 |
|
|
As ofDecember
31,2018 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
732,190 |
|
|
$ |
370,829 |
|
Short-term investments |
|
612,018 |
|
|
|
803,083 |
|
Accounts receivable |
|
50,510 |
|
|
|
49,044 |
|
Inventory |
|
140,467 |
|
|
|
125,445 |
|
Other current assets |
|
136,238 |
|
|
|
77,782 |
|
Total current assets |
|
1,671,423 |
|
|
|
1,426,183 |
|
Property and equipment, net of
accumulated depreciation of $32,612 and $28,149 as of March
31, 2019, and December 31, 2018, respectively |
|
106,280 |
|
|
|
97,024 |
|
Intangible assets, net of
accumulated amortization of $4,276 and $3,852 as of March 31,
2019, and December 31, 2018, respectively |
|
11,781 |
|
|
|
11,574 |
|
Right of use asset, net of
accumulated amortization of $1,491 and nil as of March 31,
2019 and December 31, 2018, respectively |
|
41,098 |
|
|
|
— |
|
Other assets |
|
133,313 |
|
|
|
107,294 |
|
Total assets |
$ |
1,963,895 |
|
|
$ |
1,642,075 |
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
26,499 |
|
|
$ |
33,829 |
|
Accrued expenses |
|
100,120 |
|
|
|
134,095 |
|
Deferred revenue |
|
3,985 |
|
|
|
3,303 |
|
Other current liabilities |
|
6,762 |
|
|
|
2,463 |
|
Total current liabilities |
|
137,366 |
|
|
|
173,690 |
|
Long-term debt |
|
425,752 |
|
|
|
420,554 |
|
Lease liabilities |
|
52,165 |
|
|
|
— |
|
Deferred rent and other |
|
48 |
|
|
|
15,555 |
|
Total liabilities |
|
615,331 |
|
|
|
609,799 |
|
Commitments and contingencies
(Note 15) |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Preferred stock, $0.0001 par
value, 3,333,333 shares authorized; none issued and
outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par
value, 99,000,000 shares authorized; 74,133,521 and
71,071,887 issued and outstanding at March 31, 2019, and
December 31, 2018, respectively |
|
7 |
|
|
|
7 |
|
Additional paid-in
capital |
|
3,004,107 |
|
|
|
2,611,294 |
|
Accumulated other
comprehensive income (loss) |
|
19 |
|
|
|
(99 |
) |
Accumulated deficit |
|
(1,655,569 |
) |
|
|
(1,578,926 |
) |
Total stockholders’ equity |
|
1,348,564 |
|
|
|
1,032,276 |
|
Total liabilities and stockholders’ equity |
$ |
1,963,895 |
|
|
$ |
1,642,075 |
|
|
|
|
|
|
|
|
|
(1) As of January 1, 2019, the Company adopted the
requirements of Accounting Standards Codification 842, Leases,
using the modified retrospective method as of the effective date,
and as a result, Other Assets and Liabilities are not comparable to
the prior periods presented.
Source: Sarepta Therapeutics, Inc.
Sarepta Therapeutics, Inc.Investors: Ian Estepan, 617-274-4052
iestepan@sarepta.com Media: Tracy Sorrentino, 617-301-8566
tsorrentino@sarepta.com
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