Sarepta Therapeutics Announces Third Quarter 2023 Financial Results and Recent Corporate Developments
- Net product revenues for Q3 2023 totaled $69.1 million, a 49% increase over the same quarter of the prior year.
- Total net product revenue for Q3 2023 was $309.3 million, growing 49% over the same quarter last year.
- Non-GAAP earnings stood at approximately $38.0 million in Q3 2023.
- The launch of ELEVIDYS, the first gene therapy for boys with Duchenne muscular dystrophy, was successful, with net product revenue coming in at $69.1 million.
- The topline results from the EMBARK study showed that ELEVIDYS modifies the course of the disease in patients with Duchenne, demonstrating evidence of a clinically meaningful treatment benefit.
- The FDA has confirmed that they are open to label expansion for ELEVIDYS based on the totality of the evidence from the EMBARK study.
- Sarepta Therapeutics achieved profitability on a non-GAAP basis in Q3 2023.
- None.
-
ELEVIDYS net product revenues for the quarter totaled
$69.1 million -
Total revenues, which consist of net product revenues and collaboration revenues, for the third quarter 2023 totaled
$331.8 million -
Net product revenues for the third quarter 2023 totaled
$309.3 million 49% increase over the same quarter of prior year
“The third quarter was a defining moment for Sarepta. We launched ELEVIDYS, our fourth therapy and the first gene therapy for boys with Duchenne muscular dystrophy, we continued to drive great performance of our three PMOs and importantly, on a non-GAAP basis we have achieved profitability, placing us in ever more rarified territory in biotech,” said Doug Ingram, president and CEO, Sarepta Therapeutics. “Reflecting a superb launch, ELEVIDYS net product revenue came in at
Third Quarter 2023 and Recent Development:
- Announced topline results from EMBARK, a global pivotal study of ELEVIDYS gene therapy for Duchenne muscular dystrophy: The topline results from EMBARK support the conclusion that ELEVIDYS modifies the course of the disease in patients with Duchenne. ELEVIDYS-treated patients showed an increase on the North Star Ambulatory Assessment, a measure of motor function, compared to placebo-treated patients at 52 weeks, although the primary endpoint was not met. Robust, statistically significant results on all key functional pre-specified secondary endpoints, including time to rise (p=0.0025), and 10-meter walk test (p=0.0048), demonstrated evidence of a clinically meaningful treatment benefit that was similar in magnitude and statistical significance across all age groups. No new safety signals were observed. Importantly, we have shared the EMBARK topline results with Food and Drug Administration (FDA) leadership and they have confirmed that, based on the totality of the evidence, they are open to such label expansion if supported by review of the data, and that they intend to proceed rapidly with consideration of the submission.
Conference Call
The event will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-presentations and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone.
Financial Results
For the three months ended September 30, 2023, the Company reported a GAAP net loss of
For the nine months ended September 30, 2023, the Company reported a GAAP net loss of
Revenues
For the three months ended September 30, 2023, the Company recorded total revenues of
For the three months ended September 30, 2023, the Company recorded net product revenues of
For both the three and nine months ended September 30, 2023 and 2022, the Company recognized
Cost and Expenses
Cost of sales (excluding amortization of in-licensed rights)
For the three months ended September 30, 2023, cost of sales (excluding amortization of in-licensed rights) was
Research and development
Research and development expenses were
-
$50.5 million -
$1.7 million $5.0 million $0.5 million $3.8 million -
$1.2 million -
$1.9 million -
$2.4 million -
$2.4 million -
$5.7 million -
$6.3 million -
$7.5 million -
$15.3 million -
$12.9 million
Research and development expenses were
-
$39.4 million -
$31.0 million -
$18.0 million -
$13.5 million -
$12.0 million -
$7.8 million -
$3.5 million -
$1.5 million -
$4.9 million $7.8 million $4.5 million $4.5 million $7.8 million $3.9 million -
$86.2 million $53.0 million $17.1 million -
$17.0 million
Non-GAAP research and development expenses were
Selling, general and administrative
Selling, general and administrative expenses were
-
$12.8 million -
$6.6 million -
$3.4 million -
$3.2 million -
$9.9 million
Selling, general and administrative expenses were
-
$42.6 million -
$27.3 million -
$7.3 million -
$6.1 million -
$63.8 million
Non-GAAP selling, general and administrative expenses were
Amortization of in-licensed rights
For the three and nine months ended September 30, 2023, the Company recorded amortization of in-licensed rights of approximately
Gain from Sale of Priority Review Voucher
In June 2023, the Company entered into an agreement to sell the rare pediatric disease Priority Review Voucher (ELEVIDYS PRV) it received from the FDA in connection with the approval of ELEVIDYS for consideration of
Loss on debt extinguishment
On November 14, 2017, the Company issued
Other income (expense), net
For the three months ended September 30, 2023 and 2022, other expense, net was
Income tax expense
Income tax expense for the three and nine months ended September 30, 2023 was approximately
Cash, Cash Equivalents, Restricted Cash and Investments
The Company had approximately
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 income (loss) is defined by the Company as GAAP net loss excluding interest (income) expense, net, income tax expense, 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) expense, net 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 primarily 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 the Company. Although these are recurring charges to operations, the Company 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 the Company’s control. Therefore, the Company 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 impairment of equity investments, loss (gain) on contingent consideration, net, gain from sale of the PRV and loss on debt extinguishment.
- The Company excludes from its non-GAAP results the impairment of any equity investments as it is a non-cash item and is not considered to be a normal operating expense due to the variability of amount and lack of predictability as to the occurrence and/or timing of such impairments.
- The Company excludes from its non-GAAP results the loss (gain) on contingent consideration, net related to regulatory-related contingent payments meeting the definition of a derivative to Myonexus selling shareholders as well as to academic institutions under separate license agreements as it is a non-cash item and is not considered to be normal operating expenses due to its variability of amounts and lack of predictability as to occurrence and/or timing.
- The Company excludes from its non-GAAP results the gain from sale of the PRV obtained as a result of the FDA approval of ELEVIDYS in June 2023 as it is a non-recurring event and is not indicative of the performance of the Company’s core operations, which accordingly would make it difficult to compare the Company’s results to peer companies that also provide non-GAAP disclosures.
- The Company excludes from its non-GAAP results the loss on debt extinguishment, which is considered to be a non-recurring event as it is associated with a distinct financing decision and is not indicative of the performance of the Company’s core operations, which accordingly would make it difficult to compare the Company’s results to peer companies that also provide non-GAAP disclosures.
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 net income (loss), and non-GAAP diluted net earnings (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 (eteplirsen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion, or “skipping”, 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.
EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 51 skipping.
This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval may be contingent upon verification of a clinical benefit in confirmatory trials.
EXONDYS 51 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
Important Safety Information About EXONDYS 51
Hypersensitivity reactions, bronchospasm, chest pain, cough, tachycardia, and urticaria 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 Duchenne patients (N=8) treated with EXONDYS 51 30 mg or 50 mg/kg/week by intravenous (IV) infusion with an incidence of at least
The following adverse reactions have been identified during observational studies that were conducted as part of the clinical development program and continued post approval.
In open-label observational studies, 163 patients received at least one intravenous dose of EXONDYS 51, with doses ranging between 0.5 mg/kg (0.017 times the recommended dosage) and 50 mg/kg (1.7 times the recommended dosage). All patients were male and had genetically confirmed Duchenne muscular dystrophy. Age at study entry was 6 months to 19 years. Most (
The most common adverse reactions from observational clinical studies (N=163) seen in greater than
For further information, please see the full Prescribing Information.
About VYONDYS 53
VYONDYS 53 (golodirsen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 53 of dystrophin pre-mRNA, resulting in exclusion, or “skipping,” of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 53 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping.
This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval may be contingent upon verification of a clinical benefit in confirmatory trials.
VYONDYS 53 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
Important Safety Information for VYONDYS 53
Hypersensitivity reactions, including rash, pyrexia, pruritus, urticaria, dermatitis, and skin exfoliation have occurred in VYONDYS 53-treated patients, some requiring treatment. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting the VYONDYS 53 therapy.
Kidney toxicity was observed in animals who received golodirsen. Although kidney toxicity was not observed in the clinical studies with VYONDYS 53, the clinical experience with VYONDYS 53 is limited, and kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking VYONDYS 53. Because of the effect of reduced skeletal muscle mass on creatinine measurements, creatinine may not be a reliable measure of kidney function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting VYONDYS 53. Consider also measuring glomerular filtration rate using an exogenous filtration marker before starting VYONDYS 53. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein-to-creatinine ratio every three months. Only urine expected to be free of excreted VYONDYS 53 should be used for monitoring of urine protein. Urine obtained on the day of VYONDYS 53 infusion prior to the infusion, or urine obtained at least 48 hours after the most recent infusion, may be used. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, as this reagent has the potential to cross react with any VYONDYS 53 that is excreted in the urine and thus lead to a false positive result for urine protein.
If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation.
Adverse reactions observed in at least
Other adverse reactions that occurred at a frequency greater than
For further information, please see the full Prescribing Information.
About AMONDYS 45
AMONDYS 45 (casimersen) uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to bind to exon 45 of dystrophin pre-mRNA, resulting in exclusion, or “skipping,” of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 45 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein.
AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 45 skipping.
This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45. Continued approval may be contingent upon verification of a clinical benefit in confirmatory trials.
AMONDYS 45 has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
Important Safety Information for AMONDYS 45
CONTRAINDICATION:
Known hypersensitivity to casimersen or any of the inactive ingredients. Instances of hypersensitivity including angioedema and anaphylaxis have occurred.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients who were treated with AMONDYS 45. If a hypersensitivity reaction occurs, institute appropriate medical treatment, and consider slowing the infusion, interrupting, or discontinuing the AMONDYS 45 infusion and monitor until the condition resolves.
Kidney Toxicity: Kidney toxicity was observed in animals who received casimersen. Although kidney toxicity was not observed in the clinical studies with AMONDYS 45, kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking AMONDYS 45. Because of the effect of reduced skeletal muscle mass on creatinine measurements, creatinine may not be a reliable measure of kidney function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting AMONDYS 45. Consider also measuring glomerular filtration rate using an exogenous filtration marker before starting AMONDYS 45. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein-to-creatinine ratio (UPCR) every three months. Only urine expected to be free of excreted AMONDYS 45 should be used for monitoring of urine protein. Urine obtained on the day of AMONDYS 45 infusion prior to the infusion, or urine obtained at least 48 hours after the most recent infusion, may be used. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, as this reagent has the potential to cross react with any AMONDYS 45 that is excreted in the urine and thus lead to a false positive result for urine protein.
If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation.
Adverse Reactions: Adverse reactions occurring in at least
Other adverse reactions that occurred in at least
For further information, please see the full Prescribing Information.
About ELEVIDYS (delandistrogene moxeparvovec-rokl)
ELEVIDYS is indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. This indication is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin observed in patients treated with ELEVIDYS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
ELEVIDYS has met the full statutory standards for safety and effectiveness and as such is not considered investigational or experimental.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION:
ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene.
WARNINGS AND PRECAUTIONS:
Acute Serious Liver Injury:
- Acute serious liver injury has been observed with ELEVIDYS. Administration of ELEVIDYS may result in elevations of liver enzymes (e.g., GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks.
- Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled.
- Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT and total bilirubin levels return to near baseline levels).
- Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, a consultation with a specialist is recommended.
Immune-mediated Myositis:
- In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness including dysphagia, dyspnea and hypophonia were observed.
- Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene between exons 1 to 17 and exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction.
- Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea or hypophonia as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient’s clinical presentation and medical history if these symptoms occur.
Myocarditis:
- Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials.
- Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath.
- Advise patients to contact a physician immediately if they experience cardiac symptoms.
Pre-existing Immunity against AAVrh74:
- In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all subjects developed anti-AAVrh74 antibodies.
- Perform baseline testing for the presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration.
- ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400.
Adverse Reactions:
-
The most common adverse reactions (incidence ≥
5% ) reported in clinical studies were vomiting, nausea, liver function test increased, pyrexia, and thrombocytopenia.
Sarepta is responsible for global development and manufacturing for ELEVIDYS, and distribution within the
For further information, please see the full Prescribing Information.
About Sarepta Therapeutics
Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.
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 future operations, financial performance and projections, business plans, market opportunities, priorities and research and development programs and technologies; the potential benefits of our technologies and scientific approaches; the potential benefits of ELEVIDYS, including its potential to modify the course of Duchenne; our understanding that FDA, based on the totality of the evidence, is open to a label expansion if supported by the review of the data and intend to proceed rapidly with consideration of the submission for ELEVIDYS; and expected plans and milestones.
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 comply with all FDA post-approval commitments and requirements with respect to our products in a timely manner or at all; success in preclinical and clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; certain programs may never advance in the clinic or may be discontinued for a number of reasons, including regulators imposing a clinical hold and us suspending or terminating clinical research or trials; 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; because we are developing product candidates for the treatment of certain diseases in which there is little clinical experience and we are using new endpoints or methodologies, there is increased risk that the FDA, the EMA or other regulatory authorities may not consider the endpoints of our clinical trials to provide clinically meaningful results and that these results may be difficult to analyze; we may not be able to execute on our business plans, including meeting our expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing our product candidates to market, for various reasons, some of which may be outside of our 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 our product candidates; and those risks identified under the heading “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2022 and our 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.
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.
|
||||||||||||||||
|
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Products, net |
|
$ |
309,322 |
|
|
$ |
207,774 |
|
|
$ |
779,805 |
|
|
$ |
607,836 |
|
Collaboration |
|
|
22,495 |
|
|
|
22,495 |
|
|
|
66,750 |
|
|
|
66,750 |
|
Total revenues |
|
|
331,817 |
|
|
|
230,269 |
|
|
|
846,555 |
|
|
|
674,586 |
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales (excluding amortization of in-licensed rights) |
|
|
37,026 |
|
|
|
39,952 |
|
|
|
106,167 |
|
|
|
109,190 |
|
Research and development |
|
|
194,301 |
|
|
|
216,707 |
|
|
|
681,870 |
|
|
|
663,286 |
|
Selling, general and administrative |
|
|
120,893 |
|
|
|
104,787 |
|
|
|
350,171 |
|
|
|
330,943 |
|
Amortization of in-licensed rights |
|
|
439 |
|
|
|
178 |
|
|
|
796 |
|
|
|
535 |
|
Total cost and expenses |
|
|
352,659 |
|
|
|
361,624 |
|
|
|
1,139,004 |
|
|
|
1,103,954 |
|
Operating loss |
|
|
(20,842 |
) |
|
|
(131,355 |
) |
|
|
(292,449 |
) |
|
|
(429,368 |
) |
Other loss, net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gain from sale of Priority Review Voucher |
|
|
— |
|
|
|
— |
|
|
|
102,000 |
|
|
|
— |
|
Loss on debt extinguishment |
|
|
— |
|
|
|
(125,441 |
) |
|
|
(387,329 |
) |
|
|
(125,441 |
) |
Other (expense) income, net |
|
|
(12,332 |
) |
|
|
378 |
|
|
|
17,309 |
|
|
|
(33,848 |
) |
Total other loss, net |
|
|
(12,332 |
) |
|
|
(125,063 |
) |
|
|
(268,020 |
) |
|
|
(159,289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss before income tax expense |
|
|
(33,174 |
) |
|
|
(256,418 |
) |
|
|
(560,469 |
) |
|
|
(588,657 |
) |
Income tax expense |
|
|
7,763 |
|
|
|
1,320 |
|
|
|
21,163 |
|
|
|
5,587 |
|
Net loss |
|
$ |
(40,937 |
) |
|
$ |
(257,738 |
) |
|
$ |
(581,632 |
) |
|
$ |
(594,244 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share — basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(2.94 |
) |
|
$ |
(6.56 |
) |
|
$ |
(6.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of shares of common
|
|
|
88,889 |
|
|
|
87,628 |
|
|
|
88,609 |
|
|
|
87,465 |
|
Sarepta Therapeutics, Inc.
|
||||||||||||||||
|
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP net loss |
|
$ |
(40,937 |
) |
|
$ |
(257,738 |
) |
|
$ |
(581,632 |
) |
|
$ |
(594,244 |
) |
Interest (income) expense, net |
|
|
(17,593 |
) |
|
|
6,521 |
|
|
|
(46,565 |
) |
|
|
34,390 |
|
Income tax expense |
|
|
7,763 |
|
|
|
1,320 |
|
|
|
21,163 |
|
|
|
5,587 |
|
Impairment of equity investments |
|
|
27,500 |
|
|
|
— |
|
|
|
27,821 |
|
|
|
— |
|
Loss (gain) on contingent consideration, net |
|
|
2,000 |
|
|
|
(6,700 |
) |
|
|
1,200 |
|
|
|
(6,700 |
) |
Gain from sale of Priority Review Voucher |
|
|
— |
|
|
|
— |
|
|
|
(102,000 |
) |
|
|
— |
|
Loss on debt extinguishment |
|
|
— |
|
|
|
125,441 |
|
|
|
387,329 |
|
|
|
125,441 |
|
Depreciation and amortization expense |
|
|
10,928 |
|
|
|
10,703 |
|
|
|
33,025 |
|
|
|
31,311 |
|
Stock-based compensation expense |
|
|
48,061 |
|
|
|
50,418 |
|
|
|
136,688 |
|
|
|
182,508 |
|
Non-GAAP net income (loss) |
|
$ |
37,722 |
|
|
$ |
(70,035 |
) |
|
$ |
(122,971 |
) |
|
$ |
(221,707 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-GAAP net earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Diluted Non-GAAP net earnings (loss) per share* |
|
$ |
0.37 |
|
|
$ |
(0.80 |
) |
|
$ |
(1.39 |
) |
|
$ |
(2.53 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of shares of common
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Diluted |
|
|
101,722 |
|
|
|
87,628 |
|
|
|
88,609 |
|
|
|
87,465 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
*Non-GAAP earnings per share is calculated using diluted shares whereas non-GAAP net loss per share is calculated using basic shares as all other instruments are anti-dilutive. There was a |
|
|||||||||||||||
|
|
|||||||||||||||
|
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
GAAP research and development expenses |
|
$ |
194,301 |
|
|
$ |
216,707 |
|
|
$ |
681,870 |
|
|
$ |
663,286 |
|
Stock-based compensation expense |
|
|
(22,325 |
) |
|
|
(14,795 |
) |
|
|
(60,315 |
) |
|
|
(42,330 |
) |
Depreciation and amortization expense |
|
|
(8,109 |
) |
|
|
(8,166 |
) |
|
|
(24,794 |
) |
|
|
(23,700 |
) |
Non-GAAP research and development expenses |
|
$ |
163,867 |
|
|
$ |
193,746 |
|
|
$ |
596,761 |
|
|
$ |
597,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
GAAP selling, general and administrative expenses |
|
$ |
120,893 |
|
|
$ |
104,787 |
|
|
$ |
350,171 |
|
|
$ |
330,943 |
|
Stock-based compensation expense |
|
|
(25,736 |
) |
|
|
(35,623 |
) |
|
|
(76,373 |
) |
|
|
(140,178 |
) |
Depreciation and amortization expense |
|
|
(2,380 |
) |
|
|
(2,359 |
) |
|
|
(7,435 |
) |
|
|
(7,076 |
) |
Non-GAAP selling, general and administrative expenses |
|
$ |
92,777 |
|
|
$ |
66,805 |
|
|
$ |
266,363 |
|
|
$ |
183,689 |
|
Sarepta Therapeutics, Inc.
|
||||||||
|
|
As of
|
|
|
As of
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
541,932 |
|
|
$ |
966,777 |
|
Short-term investments |
|
|
1,191,610 |
|
|
|
1,022,597 |
|
Accounts receivable |
|
|
318,855 |
|
|
|
214,628 |
|
Inventory |
|
|
244,011 |
|
|
|
203,968 |
|
Other current assets |
|
|
154,441 |
|
|
|
149,891 |
|
Total current assets |
|
|
2,450,849 |
|
|
|
2,557,861 |
|
Property and equipment, net |
|
|
212,367 |
|
|
|
180,037 |
|
Right of use assets |
|
|
133,454 |
|
|
|
64,954 |
|
Non-current inventory |
|
|
176,112 |
|
|
|
162,545 |
|
Other non-current assets |
|
|
136,925 |
|
|
|
162,969 |
|
Total assets |
|
$ |
3,109,707 |
|
|
$ |
3,128,366 |
|
|
|
|
|
|
|
|
||
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
87,948 |
|
|
$ |
95,875 |
|
Accrued expenses |
|
|
322,350 |
|
|
|
418,996 |
|
Deferred revenue, current portion |
|
|
22,494 |
|
|
|
89,244 |
|
Other current liabilities |
|
|
17,951 |
|
|
|
15,489 |
|
Total current liabilities |
|
|
450,743 |
|
|
|
619,604 |
|
Long-term debt |
|
|
1,236,755 |
|
|
|
1,544,292 |
|
Lease liabilities, net of current portion |
|
|
134,752 |
|
|
|
57,578 |
|
Deferred revenue, net of current portion |
|
|
485,000 |
|
|
|
485,000 |
|
Contingent consideration |
|
|
38,100 |
|
|
|
36,900 |
|
Other non-current liabilities |
|
|
— |
|
|
|
42 |
|
Total liabilities |
|
|
2,345,350 |
|
|
|
2,743,416 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
|
5,256,854 |
|
|
|
4,296,841 |
|
Accumulated other comprehensive loss, net of tax |
|
|
(638 |
) |
|
|
(1,664 |
) |
Accumulated deficit |
|
|
(4,491,868 |
) |
|
|
(3,910,236 |
) |
Total stockholders’ equity |
|
|
764,357 |
|
|
|
384,950 |
|
Total liabilities and stockholders’ equity |
|
$ |
3,109,707 |
|
|
$ |
3,128,366 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231101211984/en/
Investor Contact:
Ian Estepan, 617-274-4052
iestepan@sarepta.com
Media Contact:
Tracy Sorrentino, 617-301-8566
tsorrentino@sarepta.com
Source: Sarepta Therapeutics, Inc.
FAQ
What were Sarepta Therapeutics' net product revenues for Q3 2023?
What was the total revenue for Sarepta Therapeutics in Q3 2023?
Did Sarepta Therapeutics achieve profitability in Q3 2023?
What is ELEVIDYS?
What were the topline results from the EMBARK study?
What did the FDA say about label expansion for ELEVIDYS?
