Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision
genetic medicine for rare diseases, today reported financial
results for the second quarter of 2019.
“As we pass through mid-2019, we are very
pleased to announce strong performance and solid execution against
our goals. EXONDYS 51®(eteplirsen) continues to perform, with
second quarter sales at $94.7 million, 29% growth quarter over same
quarter last year. In our RNA franchise, we advanced our VYONDYS
53™(golodirsen) application, with an FDA PDUFA date of August 19,
are preparing to submit for casimersen, with a target PDUFA date in
the first half of 2020, and have commenced dosing our PPMO SRP-5051
MAD trial. With respect to our gene therapy platform, we have
completed the dosing of the 24 patients in our placebo-controlled
micro-dystrophin trial as forecasted, made significant progress in
the build out of our commercial micro-dystrophin process and
manufacturing facility, advanced our gene therapy engine, and
through internal development and partnering have added a number of
new programs to our pipeline. Beyond the LGMD 2A program
announced during the quarter, in collaboration with industry
leading gene therapy experts we are now pursuing additional gene
therapies for Rett Syndrome, cardiomyopathy, Emery-Dreifuss
muscular dystrophy type 1, and, moving outside of rare disease,
multiple sclerosis,” stated Doug Ingram, Sarepta’s President and
CEO.
Mr. Ingram continued, “With respect to our most
advanced gene therapy programs, we are in a privileged leadership
position in 2019, both from our own execution and from the
evolution of external programs. That privilege, however,
comes with an enhanced responsibility to the patient community we
serve. We have much to do in the second half of 2019, and we intend
to perform with the same level of attention to detail and urgency
as has become our reputation.”
Second Quarter 2019 and Recent Corporate
Developments
- First Patient Dosed in MOMENTUM, a Phase 2 Clinical
Trial Investigating SRP-5051: The first patient was dosed
in MOMENTUM (Study 5051-201), a global Phase 2 clinical trial of
SRP-5051, a next-generation treatment for patients with Duchenne
muscular dystrophy who are amenable to exon 51 skipping. SRP-5051
is the first investigational treatment using Sarepta’s
next-generation PPMO platform, which is designed around a
proprietary cell-penetrating peptide conjugated to the
phosphorodiamidate morpholino oligomer (PMO) backbone with the goal
of increasing drug concentration in muscle tissue. MOMENTUM is a
multi-arm, ascending dose study designed to identify the maximum
tolerated dose of SRP-5051. Informed by Study 5051-101, a
single-ascending dose study of SRP-5051, patients in the MOMENTUM
study will receive monthly intravenous (IV) infusions of SRP-5051.
The study will enroll up to 24 patients, both ambulant and
non-ambulant, between the ages of 7-21 at sites in the U.S.,
Canada, Australia and European Union. Primary and secondary
endpoints include dystrophin expression and functional and clinical
endpoints.
- Dosed 24 Patients in Study 102: 24 patients
have been dosed in Study SRP-9001-102, a blinded,
placebo-controlled trial using Sarepta’s micro-dystrophin gene
therapy candidate for Duchenne muscular dystrophy, SRP-9001.
- Conditional Approval of the Brand Name for Golodirsen
(SRP-4053) Received by U.S. Food and Drug Administration:
Sarepta received FDA’s conditional approval of VYONDYS 53™ as the
brand name for golodirsen. VYONDYS 53 (golodirsen) is Sarepta’s
phosphorodiamidate morpholino oligomer (PMO) engineered to treat
individuals with Duchenne muscular dystrophy who have genetic
mutations amenable to skipping exon 53 of the dystrophin gene.
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 5789017. Please specify to the operator
that you would like to join the “Sarepta Second 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 $276.4 million and $109.3 million, or $3.74 and $1.67 per basic
and diluted share for the second quarter of 2019 and 2018,
respectively. On a non-GAAP basis, the net loss for the second
quarter of 2019 was $61.2 million, or $0.83 per basic and diluted
share, compared to a net loss of $28.0 million for the same period
of 2018, or $0.43 per basic and diluted share.
On a GAAP basis, for the six months ended June
30, 2019, Sarepta reported a net loss of $353.0 million, or $4.85
per basic and diluted share, compared to a net loss of $144.6
million reported for the same period of 2018, or $2.22 per basic
share and diluted share. On a non-GAAP basis, the net loss for the
six months ended June 30, 2019 was $115.0 million, or $1.58 per
share, compared to a net loss of $46.0 million for the same period
of 2018, or $0.71 per share.
Net Revenues
For the three months ended June 30, 2019, the
Company recorded net revenues of $94.7 million, compared to net
revenues of $73.5 million for the same period of 2018, an increase
of $21.2 million. For the six months ended June 30, 2019, the
Company recorded net revenues of $181.7 million, compared to net
revenues of $138.1 million for six months ended June 30, 2018, an
increase of $43.5 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 June 30, 2019, cost
of sales (excluding amortization of in-licensed rights) was $15.9
million, compared to $6.7 million for the same period of 2018. For
the six months ended June 30, 2019, cost of sales (excluding
amortization of in-licensed rights) was $28.0 million, compared to
$12.3 million for the same period of 2018. The increase primarily
reflects 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, 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 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 six months
ended June 30, 2018 compared with the same period of 2019.
Research and developmentResearch and development
expenses were $113.3 million for the second quarter of 2019,
compared to $122.8 million for the same period of 2018, a decrease
of $9.6 million. The decrease in research and development expenses
primarily reflects the following:
- $44.9 million decrease in up-front and milestone payments
primarily due to $14.4 million of up-front payments as a result of
execution of certain license agreements during the second quarter
of 2019, offset by an up-front payment of $60.0 million to Myonexus
upon execution of the warrant to purchase common stock agreement in
May 2018;
- $2.7 million decrease in collaboration cost sharing with Summit
as it is winding down activities on its Utrophin platform;
- $2.2 million decrease in pre-clinical expenses primarily due to
completion of certain toxicology studies in our PPMO platform;
- $16.5 million increase in clinical and manufacturing expenses
primarily due to a continuing ramp-up of our micro-dystrophin
program, our ESSENCE program and initiation of certain post-market
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
trial in golodirsen;
- $9.9 million increase in compensation and other personnel
expenses primarily due to a net increase in headcount;
- $7.4 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;
- $1.9 million increase in stock-based compensation expense
primarily driven by increases in headcount and stock price;
and
- $3.4 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.
Research and development expenses were $203.8
million for the six months ended June 30, 2019, compared to $169.1
million for the same period of 2018, an increase of $34.8 million.
The increase in research and development expenses primarily
reflects the following:
- $35.3 million increase in clinical and manufacturing expenses
primarily due to a continuing ramp-up of our micro-dystrophin
program, our ESSENCE program and initiation of certain post-market
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
trial in golodirsen;
- $21.3 million increase in compensation and other personnel
expenses primarily due to a net increase in headcount;
- $15.7 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;
- $4.9 million increase in stock-based compensation expense
primarily driven by increases in headcount and stock price;
- $43.8 million decrease in up-front and milestone payments
primarily due to $15.5 million of up-front payments as a result of
license agreements executed during the second quarter of 2019,
offset by an up-front payment of $60 million to Myonexus upon
execution of the warrant to purchase common stock agreement in May
2018;
- $5.6 million decrease in collaboration cost sharing with Summit
as it is winding down activities on its Utrophin platform; and
- $5.9 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.
Non-GAAP research and development expenses were
$87.5 million and $57.0 million for the second quarter of 2019 and
2018, respectively, an increase of $30.6 million. Non-GAAP research
and development expenses were $168.9 million and $100.3 million for
the six months ended June 30, 2019 and 2018, respectively.
Selling, general and administrationSelling
general and administrative expenses were $67.4 million for the
second quarter of 2019, compared to $47.2 million for the same
period of 2018, an increase of $20.2 million. The increase in
selling, general and administrative expenses primarily reflects the
following:
- $8.9 million increase in compensation and other personnel
expenses primarily due to an increase in headcount;
- $3.9 million increase in professional services primarily due to
continuing global expansion;
- $3.8 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;
- $2.6 million increase in stock-based compensation primarily due
to increases in headcount and stock price; 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 our Corvallis facility recorded during the
second quarter of 2018.
Selling general and administrative expenses were
$128.0 million for the six months ended June 30, 2019, compared to
$90.5 million for the same period of 2018, an increase of $37.5
million. The increase in selling, general and administrative
expenses primarily reflects the following:
- $19.3 million increase in compensation and other personnel
expenses primarily due to an increase in headcount;
- $5.3 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;
- $5.2 million increase in stock-based compensation primarily due
to increases in headcount and stock price;
- $4.6 million increase in professional services primarily due to
continuing global expansion; 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 our Corvallis facility recorded during the
second quarter of 2018.
Non-GAAP selling, general and administrative
expenses were $52.3 million and $37.3 million for the second
quarter of 2019 and 2018, respectively, an increase of $14.9
million. Non-GAAP selling, general and administrative expenses were
$100.1 million and $71.0 million for the six months ended June 30,
2019 and 2018, respectively, an increase of $29.1 million.
Acquired in-process research and development
As a result of the Myonexus acquisition, we
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 the three
and six months ended June 30, 2019, and 2018, we recorded
amortization of in-licensed rights of approximately $0.2 million
and $0.4 million, respectively.
Other loss
Other expense, net
For the three and six months ended June 30,
2019, other expense, net was approximately $0.9 million and $1.0
million, respectively. For the three and six months ended June 30,
2018, other expense, net was approximately $5.2 million and $9.7
million, respectively. The decrease primarily reflected 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 $1.1 billion in
cash, cash equivalents and investments as of June 30, 2019 compared
to $1.2 billion as of December 31, 2018. The decrease 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 half 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 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 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 the potential benefits of our
product, product candidates and programs, including those with
strategic partners; an expected FDA PDUFA date for golodirsen of
August 19, 2019; a target PDUFA date for casimersen in the first
half of 2020; our gene therapy position in 2019 and our plans to
perform with the same level of attention to detail and urgency;
PPMO’s potential to increase drug concentration in muscle tissue;
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 our programs and
collaborations 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 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 EndedJune
30, |
|
|
For the Six Months EndedJune
30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product, net |
|
$ |
94,668 |
|
|
$ |
73,529 |
|
|
$ |
181,679 |
|
|
$ |
138,133 |
|
Total revenues |
|
|
94,668 |
|
|
|
73,529 |
|
|
|
181,679 |
|
|
|
138,133 |
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excluding amortization of in-licensed
rights) |
|
|
15,919 |
|
|
|
6,735 |
|
|
|
27,982 |
|
|
|
12,317 |
|
Research and development |
|
|
113,266 |
|
|
|
122,848 |
|
|
|
203,819 |
|
|
|
169,052 |
|
Selling, general and administrative |
|
|
67,393 |
|
|
|
47,156 |
|
|
|
127,959 |
|
|
|
90,497 |
|
Acquired in-process research and development |
|
|
173,240 |
|
|
|
— |
|
|
|
173,240 |
|
|
|
— |
|
Amortization of in-licensed rights |
|
|
217 |
|
|
|
217 |
|
|
|
433 |
|
|
|
433 |
|
Total cost and expenses |
|
|
370,035 |
|
|
|
176,956 |
|
|
|
533,433 |
|
|
|
272,299 |
|
Operating loss |
|
|
(275,367 |
) |
|
|
(103,427 |
) |
|
|
(351,754 |
) |
|
|
(134,166 |
) |
Other loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
|
(862 |
) |
|
|
(5,218 |
) |
|
|
(1,034 |
) |
|
|
(9,703 |
) |
Other loss |
|
|
(862 |
) |
|
|
(5,218 |
) |
|
|
(1,034 |
) |
|
|
(9,703 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
expense |
|
|
(276,229 |
) |
|
|
(108,645 |
) |
|
|
(352,788 |
) |
|
|
(143,869 |
) |
Income tax expense |
|
|
174 |
|
|
|
622 |
|
|
|
258 |
|
|
|
761 |
|
Net loss |
|
|
(276,403 |
) |
|
|
(109,267 |
) |
|
|
(353,046 |
) |
|
|
(144,630 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted |
|
$ |
(3.74 |
) |
|
$ |
(1.67 |
) |
|
$ |
(4.85 |
) |
|
$ |
(2.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock used in computing basic and diluted net loss
per share |
|
|
73,958 |
|
|
|
65,484 |
|
|
|
72,850 |
|
|
|
65,060 |
|
Sarepta Therapeutics, Inc. |
|
Reconciliation of GAAP Financial Measures to Non-GAAP Financial
Measures |
|
(unaudited, in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(276,403 |
) |
|
$ |
(109,267 |
) |
|
$ |
(353,046 |
) |
|
$ |
(144,630 |
) |
Interest expense, net |
|
|
741 |
|
|
|
4,689 |
|
|
|
1,383 |
|
|
|
9,192 |
|
Income tax expense |
|
|
174 |
|
|
|
622 |
|
|
|
258 |
|
|
|
761 |
|
Depreciation and amortization expense |
|
|
6,233 |
|
|
|
2,873 |
|
|
|
11,113 |
|
|
|
5,125 |
|
Stock-based compensation expense |
|
|
19,762 |
|
|
|
15,279 |
|
|
|
35,901 |
|
|
|
25,805 |
|
Restructuring expense |
|
|
— |
|
|
|
(2,222 |
) |
|
|
— |
|
|
|
(2,222 |
) |
Up-front, milestone, and other expenses |
|
|
15,078 |
|
|
|
60,000 |
|
|
|
16,200 |
|
|
|
60,000 |
|
Acquired in-process research and development |
|
|
173,240 |
|
|
|
— |
|
|
|
173,240 |
|
|
|
— |
|
Non-GAAP net loss |
|
$ |
(61,175 |
) |
|
$ |
(28,026 |
) |
|
$ |
(114,951 |
) |
|
$ |
(45,969 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.83 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.58 |
) |
|
$ |
(0.71 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock outstanding for computing: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
73,958 |
|
|
|
65,484 |
|
|
|
72,850 |
|
|
|
65,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
GAAP research and development
expenses |
|
$ |
113,266 |
|
|
$ |
122,848 |
|
|
$ |
203,819 |
|
|
$ |
169,052 |
|
Up-front, milestone, and other expenses |
|
|
(15,078 |
) |
|
|
(60,000 |
) |
|
|
(16,200 |
) |
|
|
(60,000 |
) |
Stock-based compensation expense |
|
|
(6,923 |
) |
|
|
(5,029 |
) |
|
|
(12,010 |
) |
|
|
(7,089 |
) |
Depreciation and amortization expense |
|
|
(3,725 |
) |
|
|
(853 |
) |
|
|
(6,687 |
) |
|
|
(1,701 |
) |
Non-GAAP research and
development expenses |
|
$ |
87,540 |
|
|
$ |
56,966 |
|
|
$ |
168,922 |
|
|
$ |
100,262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
GAAP selling, general and
administrative expenses |
|
$ |
67,393 |
|
|
$ |
47,156 |
|
|
$ |
127,959 |
|
|
$ |
90,497 |
|
Stock-based compensation expense |
|
|
(12,839 |
) |
|
|
(10,250 |
) |
|
|
(23,891 |
) |
|
|
(18,716 |
) |
Depreciation and amortization expense |
|
|
(2,291 |
) |
|
|
(1,803 |
) |
|
|
(3,993 |
) |
|
|
(2,991 |
) |
Restructuring expense |
|
|
— |
|
|
|
2,222 |
|
|
|
— |
|
|
|
2,222 |
|
Non-GAAP selling, general and
administrative expenses |
|
$ |
52,263 |
|
|
$ |
37,325 |
|
|
$ |
100,075 |
|
|
$ |
71,012 |
|
Sarepta
Therapeutics, Inc. |
Condensed
Consolidated Balance Sheets |
(unaudited, in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As ofJune
30,2019 |
|
|
As ofDecember
31,2018 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
808,591 |
|
|
$ |
370,829 |
|
Short-term investments |
|
|
294,478 |
|
|
|
803,083 |
|
Accounts receivable |
|
|
56,981 |
|
|
|
49,044 |
|
Inventory |
|
|
156,569 |
|
|
|
125,445 |
|
Other current assets |
|
|
110,799 |
|
|
|
77,782 |
|
Total current assets |
|
|
1,427,418 |
|
|
|
1,426,183 |
|
Property and equipment, net of
accumulated depreciation of $38,398 and $28,149
as of June 30, 2019, and December 31, 2018, respectively |
|
|
117,201 |
|
|
|
97,024 |
|
Intangible assets, net of
accumulated amortization of $4,685 and $3,852 as of
June 30, 2019, and December 31, 2018, respectively |
|
|
11,825 |
|
|
|
11,574 |
|
Right of use asset, net |
|
|
39,449 |
|
|
|
— |
|
Other assets |
|
|
151,860 |
|
|
|
107,294 |
|
Total assets |
|
$ |
1,747,753 |
|
|
$ |
1,642,075 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
44,045 |
|
|
$ |
33,829 |
|
Accrued expenses |
|
|
107,328 |
|
|
|
134,095 |
|
Deferred revenue |
|
|
3,303 |
|
|
|
3,303 |
|
Other current liabilities |
|
|
7,413 |
|
|
|
2,463 |
|
Total current liabilities |
|
|
162,089 |
|
|
|
173,690 |
|
Long-term debt |
|
|
431,040 |
|
|
|
420,554 |
|
Lease liabilities |
|
|
50,209 |
|
|
|
— |
|
Deferred rent and other |
|
|
5,248 |
|
|
|
15,555 |
|
Total liabilities |
|
|
648,586 |
|
|
|
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; 74,327,767 and
71,071,887 issued and outstanding at June 30, 2019, and
December 31, 2018, respectively |
|
|
7 |
|
|
|
7 |
|
Additional paid-in
capital |
|
|
3,031,050 |
|
|
|
2,611,294 |
|
Accumulated other
comprehensive income (loss) |
|
|
82 |
|
|
|
(99 |
) |
Accumulated deficit |
|
|
(1,931,972 |
) |
|
|
(1,578,926 |
) |
Total stockholders’ equity |
|
|
1,099,167 |
|
|
|
1,032,276 |
|
Total liabilities and stockholders’ equity |
|
$ |
1,747,753 |
|
|
$ |
1,642,075 |
|
Note: 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
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