Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision
genetic medicine for rare diseases, today reported financial
results for the third quarter of 2019.
“EXONDYS 51® (eteplirsen) enjoyed another strong
quarter, with third quarter 2019 revenues of $99.0 million, a 26%
increase over the same quarter in 2018. Based on
current performance, we have raised our full-year 2019 guidance
from a range of $365 to $375 million to $370 to $380 million,”
stated Doug Ingram, Sarepta’s President and CEO.
Mr. Ingram continued, “We have also made
significant progress advancing our gene therapy platform. In the
quarter, we increased the study enrollment size of our current
double-blind, placebo-controlled trial, significantly increasing
study power. We are now actively screening and dosing patients at
two sites, with the goal of completing all dosing by year end. We
have also made progress on gene therapy manufacturing capacity,
analytical development and process development and remain on track
to initiate our next trial, using commercial process supply, by
mid-2020. We also announced positive nine-month functional
results from a cohort of three limb-girdle muscular dystrophy Type
2E clinical trial participants who received our investigational
gene therapy candidate, SRP-9003. As reported at the World
Muscle Conference in Copenhagen on October 5th, at Day 270 all
three participants showed improvements from baseline across all
functional measures, including the modified NSAA, time to rise,
four-stair climb, 100-meter walk test and 10-meter walk test, and
no new safety signals were observed.”
Mr. Ingram concluded, “While not without its
challenges, 2019 has been one marked by a significant advancement
of our platform. We continued to exceed revenue expectations,
built our pipeline and advanced our programs, reported additional
positive and validating clinical data, advanced our manufacturing
strategy, and expanded and enhanced the expertise of our team of
Sarepta employees. Through these efforts we have taken great
strides toward our goal to be among the world’s leaders in genetic
medicine for those with life-limiting and too often life-ending
rare diseases.”
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 8998299. Please specify to the operator
that you would like to join the “Sarepta Third 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 $126.3 million and $76.4 million, or $1.70 and $1.15 per basic
and diluted share for the third quarter of 2019 and 2018,
respectively. On a non-GAAP basis, the net loss for the third
quarter of 2019 was $84.4 million, or $1.14 per basic and diluted
share, compared to a net loss of $37.1 million, or $0.56 per basic
and diluted share for the same period of 2018.
On a GAAP basis, for the nine months ended
September 30, 2019, the Company reported a net loss of $479.4
million, or $6.54 per basic and diluted share, compared to a net
loss of $221.0 million, or $3.38 per basic and diluted share for
the same period of 2018. On a non-GAAP basis, the net loss for the
nine months ended September 30, 2019 was $199.4 million, or $2.72
per basic and diluted share, compared to a net loss of $83.1
million, or $1.27 per basic and diluted share for the same period
of 2018.
Net Revenues
For the three months ended September 30, 2019,
the Company recorded net revenues of $99.0 million, compared to net
revenues of $78.5 million for the same period of 2018, an increase
of $20.5 million. For the nine months ended September 30, 2019, the
Company recorded net revenues of $280.7 million, compared to net
revenues of $216.6 million for nine months ended September 30,
2018, an increase of $64.1 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 September 30, 2019,
cost of sales (excluding amortization of in-licensed rights) was
$13.0 million, compared to $8.7 million for the same period of
2018. For the nine months ended September 30, 2019, cost of sales
(excluding amortization of in-licensed rights) was $41.0 million,
compared to $21.1 million for the same period of 2018. The
increases primarily reflect royalty payments to BioMarin
Pharmaceuticals (BioMarin) and University of Western Australia
(UWA), and higher product costs as a result of increasing demand
for EXONDYS 51. Prior to the approval of EXONDYS51, 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 nine months ended September 30, 2018
compared with the same period of 2019.
Research and development
Research and development expenses were $133.9
million for the third quarter of 2019, compared to $86.6 million
for the same period of 2018, an increase of $47.3 million. The
increase in research and development expenses primarily reflects
the following:
- $35.8 million increase in clinical and manufacturing expenses
primarily due to a continuing ramp-up of the Company’s
micro-dystrophin program, the Company’s ESSENCE program and
initiation of certain post-market studies for EXONDYS 51. The
increases were offset by a ramp-down of the PROMOVI trial in
EXONDYS 51 and the Phase 1/2 trial in golodirsen;
- $7.7 million increase in compensation and other personnel
expenses primarily due to a net increase in headcount;
- $7.3 million increase in facility- and technology-related
expenses due to the Company’s continuing global expansion efforts
as well as a change in methodology in allocation of technology
expense;
- $3.7 million increase in stock-based compensation expense
primarily driven by increases in headcount and stock price;
- $3.0 million increase in professional services primarily due to
continuing accelerated company growth as a result of expansion of
the Company’s research and development pipeline;
- $2.5 million increase in research and other primarily driven by
an increase in lab supplies as a result of an increase in headcount
as well as sponsored research with academic institutions;
- $5.9 million decrease in up-front, milestone, and other
expenses primarily due to $10.0 million of an up-front payment due
as a result of execution of a license agreement during the third
quarter of 2019, as compared with a $10.0 million milestone payment
to Myonexus Therapeutics, Inc. (“Myonexus”) as a result of the
achievement of a development milestone in September 2018 as well as
$8.0 million related to the purchase of a license to develop,
manufacture and commercialize a pre-clinical Pompe product
candidate under the license agreement with Lacerta Therapeutics,
Inc. (“Lacerta”) in August 2018;
- $5.3 million decrease in pre-clinical expenses primarily due to
completion of certain toxicology studies in the Company’s PPMO
platform; and
- $1.6 million decrease in collaboration cost sharing with Summit
(Oxford) Ltd. (“Summit”) as it is winding down activities on its
Utrophin platform.
Research and development expenses were $337.8
million for the nine months ended September 30, 2019, compared to
$255.6 million for the same period of 2018, an increase of $82.2
million. The increase in research and development expenses
primarily reflects the following:
- $71.1 million increase in clinical and manufacturing expenses
primarily due to a continuing ramp-up of the Company’s
micro-dystrophin program, the Company’s ESSENCE program and
initiation of certain post-market studies for EXONDYS 51. The
increases were offset by a ramp-down of the PROMOVI trial in
EXONDYS 51 and the Phase 1/2 trial in golodirsen;
- $29.1 million increase in compensation and other personnel
expenses primarily due to a net increase in headcount;
- $22.9 million increase in facility- and technology-related
expenses due to the Company’s continuing expansion efforts as well
as a change in methodology in allocation of technology
expense;
- $8.6 million increase in stock-based compensation expense
primarily driven by increases in headcount and stock price;
- $8.5 million increase in research and other primarily driven by
an increase in lab supplies as a result of an increase in headcount
as well as sponsored research with academic institutions;
- $4.2 million increase in professional services primarily due to
continuing accelerated company growth as a result of expansion of
the Company’s research and development pipeline;
- $49.7 million decrease in up-front, milestone, and other
expenses primarily due to $25.5 million of up-front payments as a
result of license agreements executed during the nine months ended
September 30, 2019, as compared with an up-front payment of $60.0
million to Myonexus upon execution of the warrant to purchase
common stock agreement in May 2018, a milestone payment of $10.0
million to Myonexus upon achievement of a development milestone in
September 2018 and $8.0 million related to the purchase of a
license to develop, manufacture and commercialize a pre-clinical
Pompe product candidate under the license agreement with Lacerta in
August 2018;
- $7.2 million decrease in collaboration cost sharing with Summit
as it is winding down activities on its Utrophin platform; and
- $5.4 million decrease in pre-clinical expenses primarily due to
completion of certain toxicology studies in the Company’s PPMO
platform.
Non-GAAP research and development expenses were
$110.5 million and $64.2 million for the third quarter of 2019 and
2018, respectively, an increase of $46.3 million. Non-GAAP research
and development expenses were $279.4 million and $164.5 million for
the nine months ended September 30, 2019 and 2018, respectively, an
increase of $114.9 million.
Selling, general and administrationSelling
general and administrative expenses were $75.4 million for the
third quarter of 2019, compared to $53.0 million for the same
period of 2018, an increase of $22.4 million. The increase in
selling, general and administrative expenses primarily reflects the
following:
- $8.4 million increase in compensation and other personnel
expenses primarily due to a net increase in headcount;
- $5.4 million increase in stock-based compensation primarily due
to increases in headcount and stock price;
- $5.2 million increase in professional services primarily due to
continuing global expansion; and
- $4.3 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.
Selling, general and administrative expenses
were $203.4 million for the nine months ended September 30, 2019,
compared to $143.5 million for the same period of 2018, an increase
of $59.9 million. The increase in selling, general and
administrative expenses primarily reflects the following:
- $27.7 million increase in compensation and other personnel
expenses primarily due to a net increase in headcount;
- $10.6 million increase in stock-based compensation primarily
due to increases in headcount and stock price;
- $9.7 million increase in professional services primarily due to
continuing global expansion;
- $7.9 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
- $2.2 million decrease in restructuring credits due to the
relief of cease-use liabilities as a result of the termination of
the rental agreement for the Company’s Corvallis facility recorded
during the second quarter of 2018.
Non-GAAP selling, general and administrative
expenses were $59.6 million and $42.5 million for the third quarter
of 2019 and 2018, respectively, an increase of $17.1 million.
Non-GAAP selling, general and administrative expenses were $159.7
million and $113.5 million for the nine months ended September 30,
2019 and 2018, respectively, an increase of $46.2 million.
Acquired in-process research and development
As a result of the Myonexus acquisition, the
Company recorded acquired in-process research and development
expense of approximately $173.2 million during the second quarter
of 2019. There was no such transaction during the same period of
2018.
Amortization of in-licensed rightsFor both the
three and nine months ended September 30, 2019, and 2018, the
Company recorded amortization of in-licensed rights of
approximately $0.2 million and $0.6 million, respectively.
Other expense, net
For the three and nine months ended September
30, 2019, other expense, net was approximately $2.5 million and
$3.5 million, respectively. For the three and nine months ended
September 30, 2018, other expense, net was approximately $7.0
million and $16.7 million, respectively. The decrease primarily
reflected a decrease in term loan termination expense and an
increase in 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 $1.1 billion in
cash, cash equivalents and investments as of September 30, 2019
compared to $1.2 billion as of December 31, 2018. The decrease is
primarily driven by cash used to fund the Company’s ongoing
operations during the first three quarters of 2019 offset by the
proceeds of the public offering of common stock in March 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 and acquired in-process research
and development expense. The Company excludes up-front, milestone,
and acquired in-process research and development 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. As a result of the Myonexus acquisition, the Company
recorded acquired in-process research and development expense,
which represents a non-recurring expense and, therefore, was
treated as a non-GAAP adjustment item. 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 Limb-girdle muscular dystrophy diseases (LGMD), 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 our full-year 2019 guidance of $370
to $380 million; our goal of completing all dosing in our current
double-blind, placebo-controlled trial by year end; our plan to
initiate our next micro-dystrophin gene therapy trial, using
commercial process supply, by mid-2020; our goal to be among the
world’s leaders in genetic medicine for those with life-limiting
and ending rare diseases; 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; 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 early results from a clinical trial do not
necessarily predict final results; our data for golodirsen,
casimersen, SRP-9001, SRP-9003 and/or other programs may not be
sufficient for obtaining regulatory approval; if the actual number
of patients suffering from the diseases we aim to treat 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 EndedSeptember
30, |
|
|
For the Nine Months EndedSeptember
30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product, net |
|
$ |
99,041 |
|
|
$ |
78,486 |
|
|
$ |
280,720 |
|
|
$ |
216,619 |
|
Total revenues |
|
|
99,041 |
|
|
|
78,486 |
|
|
|
280,720 |
|
|
|
216,619 |
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excluding amortization of in-licensed
rights) |
|
|
13,037 |
|
|
|
8,741 |
|
|
|
41,019 |
|
|
|
21,058 |
|
Research and development |
|
|
133,949 |
|
|
|
86,584 |
|
|
|
337,768 |
|
|
|
255,636 |
|
Selling, general and administrative |
|
|
75,429 |
|
|
|
53,044 |
|
|
|
203,388 |
|
|
|
143,541 |
|
Acquired in-process research and development |
|
|
— |
|
|
|
— |
|
|
|
173,240 |
|
|
|
— |
|
Amortization of in-licensed rights |
|
|
216 |
|
|
|
216 |
|
|
|
649 |
|
|
|
649 |
|
Total cost and expenses |
|
|
222,631 |
|
|
|
148,585 |
|
|
|
756,064 |
|
|
|
420,884 |
|
Operating loss |
|
|
(123,590 |
) |
|
|
(70,099 |
) |
|
|
(475,344 |
) |
|
|
(204,265 |
) |
Other loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
|
(2,510 |
) |
|
|
(6,968 |
) |
|
|
(3,544 |
) |
|
|
(16,671 |
) |
Other loss |
|
|
(2,510 |
) |
|
|
(6,968 |
) |
|
|
(3,544 |
) |
|
|
(16,671 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
expense |
|
|
(126,100 |
) |
|
|
(77,067 |
) |
|
|
(478,888 |
) |
|
|
(220,936 |
) |
Income tax expense
(benefit) |
|
|
226 |
|
|
|
(674 |
) |
|
|
484 |
|
|
|
87 |
|
Net loss |
|
$ |
(126,326 |
) |
|
$ |
(76,393 |
) |
|
$ |
(479,372 |
) |
|
$ |
(221,023 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
|
$ |
(1.70 |
) |
|
$ |
(1.15 |
) |
|
$ |
(6.54 |
) |
|
$ |
(3.38 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock used in computing basic and diluted net loss
per share |
|
|
74,177 |
|
|
|
66,209 |
|
|
|
73,298 |
|
|
|
65,454 |
|
Sarepta Therapeutics, Inc.Reconciliation of
GAAP Financial Measures to Non-GAAP Financial Measures(unaudited,
in thousands, except per share amounts)
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(126,326 |
) |
|
$ |
(76,393 |
) |
|
$ |
(479,372 |
) |
|
$ |
(221,023 |
) |
Interest expense, net |
|
|
2,136 |
|
|
|
6,909 |
|
|
|
3,519 |
|
|
|
16,101 |
|
Income tax expense (benefit) |
|
|
226 |
|
|
|
(674 |
) |
|
|
484 |
|
|
|
87 |
|
Depreciation and amortization expense |
|
|
6,741 |
|
|
|
3,593 |
|
|
|
17,854 |
|
|
|
8,718 |
|
Stock-based compensation expense |
|
|
20,637 |
|
|
|
11,484 |
|
|
|
56,538 |
|
|
|
37,289 |
|
Restructuring benefit |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,222 |
) |
Up-front, milestone, and other expenses |
|
|
12,146 |
|
|
|
18,000 |
|
|
|
28,346 |
|
|
|
78,000 |
|
Acquired in-process research and development |
|
|
— |
|
|
|
— |
|
|
|
173,240 |
|
|
|
— |
|
Non-GAAP net loss |
|
$ |
(84,440 |
) |
|
$ |
(37,081 |
) |
|
$ |
(199,391 |
) |
|
$ |
(83,050 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(1.14 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.72 |
) |
|
$ |
(1.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock outstanding for computing: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
74,177 |
|
|
|
66,209 |
|
|
|
73,298 |
|
|
|
65,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
GAAP research and development
expenses |
|
$ |
133,949 |
|
|
$ |
86,584 |
|
|
$ |
337,768 |
|
|
$ |
255,636 |
|
Up-front, milestone, and other expenses |
|
|
(12,146 |
) |
|
|
(18,000 |
) |
|
|
(28,346 |
) |
|
|
(78,000 |
) |
Stock-based compensation expense |
|
|
(6,972 |
) |
|
|
(3,260 |
) |
|
|
(18,982 |
) |
|
|
(10,349 |
) |
Depreciation and amortization expense |
|
|
(4,365 |
) |
|
|
(1,092 |
) |
|
|
(11,052 |
) |
|
|
(2,793 |
) |
Non-GAAP research and
development expenses |
|
$ |
110,466 |
|
|
$ |
64,232 |
|
|
$ |
279,388 |
|
|
$ |
164,494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
GAAP selling, general and
administrative expenses |
|
$ |
75,429 |
|
|
$ |
53,044 |
|
|
$ |
203,388 |
|
|
$ |
143,541 |
|
Stock-based compensation expense |
|
|
(13,665 |
) |
|
|
(8,224 |
) |
|
|
(37,556 |
) |
|
|
(26,940 |
) |
Depreciation and amortization expense |
|
|
(2,160 |
) |
|
|
(2,285 |
) |
|
|
(6,153 |
) |
|
|
(5,276 |
) |
Restructuring benefit |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,222 |
|
Non-GAAP selling, general and
administrative expenses |
|
$ |
59,604 |
|
|
$ |
42,535 |
|
|
$ |
159,679 |
|
|
$ |
113,547 |
|
Sarepta Therapeutics, Inc.Condensed Consolidated
Balance Sheets(unaudited, in thousands, except share and per share
data)
|
|
As ofSeptember
30,2019 |
|
|
As ofDecember
31,2018 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
724,829 |
|
|
$ |
370,829 |
|
Short-term investments |
|
|
324,063 |
|
|
|
803,083 |
|
Accounts receivable |
|
|
68,032 |
|
|
|
49,044 |
|
Inventory |
|
|
166,360 |
|
|
|
125,445 |
|
Other current assets |
|
|
79,015 |
|
|
|
77,782 |
|
Total current assets |
|
|
1,362,299 |
|
|
|
1,426,183 |
|
Property and equipment, net of
accumulated depreciation of $44,701 and $28,149 as of
September 30, 2019, and December 31, 2018, respectively |
|
|
119,532 |
|
|
|
97,024 |
|
Intangible assets, net of
accumulated amortization of $5,091 and $3,852 as of September
30, 2019, and December 31, 2018, respectively |
|
|
11,975 |
|
|
|
11,574 |
|
Right of use asset, net |
|
|
39,493 |
|
|
|
— |
|
Other assets |
|
|
169,171 |
|
|
|
107,294 |
|
Total assets |
|
$ |
1,702,470 |
|
|
$ |
1,642,075 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
81,946 |
|
|
$ |
33,829 |
|
Accrued expenses |
|
|
121,663 |
|
|
|
134,095 |
|
Deferred revenue |
|
|
3,303 |
|
|
|
3,303 |
|
Other current liabilities |
|
|
8,944 |
|
|
|
2,463 |
|
Total current liabilities |
|
|
215,856 |
|
|
|
173,690 |
|
Long-term debt |
|
|
436,421 |
|
|
|
420,554 |
|
Lease liabilities |
|
|
49,741 |
|
|
|
— |
|
Deferred rent and other |
|
|
5,248 |
|
|
|
15,555 |
|
Total liabilities |
|
|
707,266 |
|
|
|
609,799 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
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; 74,504,835 and 71,071,887
issued and outstanding at September 30, 2019, and December 31,
2018, respectively |
|
|
7 |
|
|
|
7 |
|
Additional paid-in
capital |
|
|
3,053,420 |
|
|
|
2,611,294 |
|
Accumulated other
comprehensive income (loss) |
|
|
75 |
|
|
|
(99 |
) |
Accumulated deficit |
|
|
(2,058,298 |
) |
|
|
(1,578,926 |
) |
Total stockholders’ equity |
|
|
995,204 |
|
|
|
1,032,276 |
|
Total liabilities and stockholders’ equity |
|
$ |
1,702,470 |
|
|
$ |
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 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
Sarepta Therapeutics (NASDAQ:SRPT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sarepta Therapeutics (NASDAQ:SRPT)
Historical Stock Chart
From Sep 2023 to Sep 2024