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Sarepta Therapeutics Announces Second Quarter 2018 Financial Results and Recent Corporate Developments
08/08/18 4:02 PM EDT
“We are very pleased to report another strong quarter, marrying our vision to become one of the most meaningful precision genetic medicine companies globally with a strong focus on execution against both our near- and long-term range goals,” stated
Mr. Ingram continued, “We have entered into our next gene therapy collaboration, with Lacerta Therapeutics, gaining access to world-leading talent, next-generation tools, and three additional gene therapy programs, one focused on Pompe Disease and two additional CNS-targeted programs, with the purpose of supporting our strategic expansion. Over the remainder of 2018, we have much to do and also numerous catalysts that have the potential to solidify us as a leader in precision genetic medicine and a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare, genetic-based disease.”
Second Quarter 2018 and Recent Corporate Developments
Lacerta Therapeutics Partnership : After the close of the quarter, onAugust 8, 2018 , Sarepta signed a long-term strategic partnership with Lacerta Therapeutics, a spin out of theUniversity of Florida , one of the top gene therapy research centers of excellence. Under the terms of the agreement, Sarepta will receive exclusive rights to Lacerta’s program focused on CNS-targeted gene therapy to treat Pompe Disease, along with an option to two additional rare CNS-targeted gene therapy programs. Lacerta will manage the majority of the pre-clinical development while Sarepta will lead clinical development and commercialization. Sarepta will owe development and sales-based milestones to Lacerta and pay single-digit royalties on net sales. Sarepta will make an equity investment of$30 million .
- Positive Preliminary Phase 1/2a Gene Therapy Micro-dystrophin Trial Results in DMD Patients: At Sarepta’s first R&D Day held on
June 19, 2018 ,Jerry Mendell , M.D. of Nationwide Children’s Hospital presented positive preliminary results from its Phase 1/2a gene therapy clinical trial assessing AAVrh74.MHCK7.micro-Dystrophin in individuals with DMD. In all three patients, the three-month biopsy results showed robust gene expression as measured by Western blot and immunohistochemistry and unprecedented drops in levels of creatine kinase, an enzyme associated with muscle damage which is a hallmark of Duchenne muscular dystrophy.
- Executive Leadership Appointments: Gilmore O’Neill, M.B., M.M.Sc. was appointed as Sarepta’s chief medical officer on
June 7, 2018 . Dr. O’Neill leads all clinical development, medical affairs, pharmacovigilance, and regulatory affairs. At Biogen, he held leadership roles of increasing responsibility over a 15-year period in research and development, most recently as senior vice president responsible for all late-stage clinical development, and oversaw development programs for Alzheimer’s disease, movement disorders, acute neurology, multiple sclerosis, pain, neuromuscular disease, gene and cell therapy, and rare diseases. He played a leadership role in seeking, receiving and maintaining global marketing approvals for Tecfidera®, Zinbryta®, Plegridy® and Spinraza®.
- CHMP Opinion: On
June 1, 2018 , TheCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA), adopted a negative opinion for the eteplirsen Marketing Authorization Application (MAA), as anticipated. Sarepta has commenced a re-examination of the CHMP opinion and CHMP is convening aScientific Advisory Group (SAG), made up of neuromuscular experts, in the fall of 2018 to review the MAA. A final decision is expected by year-end 2018.
Brammer Bio Partnership : Sarepta signed a long-term strategic manufacturing partnership with Brammer Bio, granting Sarepta access to clinical and commercial manufacturing capacity for its micro-dystrophin DMD gene therapy program and a manufacturing platform for future gene therapy programs.
Sarepta has adopted a hybrid internal and external development and manufacturing model. Under this model, Sarepta will continue to build internal expertise in all aspects of AAV-based manufacturing while partnering with Brammer Bio to provide scalable best-in-class manufacturing capabilities. The collaboration model will integrate process development, clinical production and testing, and commercial manufacturing with the goal of bringing micro-dystrophin gene therapies to the patient community urgently and in sufficient supply.
Brammer Bio will partner with Sarepta to design and build dedicated commercial manufacturing capacity within their facility with cutting-edge capabilities. Once complete, the facility is expected to provide robust manufacturing capacity to support the unusually high demands for systemic administration of the micro-dystrophin therapy for Duchenne muscular dystrophy.
Conference Call
The Company will be hosting a conference call at
Financial Results
On a GAAP basis, Sarepta reported a net loss of
On a GAAP basis, for the six months ended
Net Revenues
For the three months ended
Cost and Operating Expenses
Cost of sales (excluding amortization of in-licensed rights)
For the three months ended
Research and development
Research and development expenses were
$38.0 million increase in up-front and milestone payments. The Company made an up-front payment of$60.0 million to Myonexus Therapeutics (Myonexus) upon execution of the partnership agreement inMay 2018 . InMay 2017 , the Company made a milestone payment of$22.0 million toSummit (Oxford) Ltd. (Summit) as the milestone of the last patient dosed in the safety arm cohort to the PhaseOut DMD study was achieved;$7.8 million increase in clinical and manufacturing expenses primarily due to increased patient enrollment in the on-going ESSENCE trial as well as a ramp-up of manufacturing activities for golodirsen, casimersen and our PPMO platform. These increases were partially offset by a ramp-down of clinical trials in eteplirsen primarily because the PROMOVI trial has been fully enrolled;$6 .0 million increase in compensation and other personnel expenses primarily due to a net increase in headcount;$2.9 million increase in collaboration cost sharing with Summit on its utrophin platform;$2.8 million in stock-based compensation expense primarily driven by change in headcount as well as achievement of a milestone related to theSeptember 2016 restricted stock awards with performance condition;$2.5 million increase in preclinical expenses primarily due to the continuing ramp-up of toxicology studies in our PPMO platform as well as golodirsen and casimersen;$1.6 million increase in professional services primarily due to accelerated company growth as a result of expansion of our R&D pipeline; and$1.4 million increase in facility-related expenses due to our continuing expansion.
Research and development expenses were
$38.0 million increase in up-front and milestone payments. The Company made an up-front payment of$60.0 million to Myonexus upon execution of the warrant to purchase common stock agreement inMay 2018 . InMay 2017 , the Company made a milestone payment of$22.0 million to Summit as the milestone of the last patient dosed in the safety arm cohort to the PhaseOut DMD study was achieved;$12.2 million increase in clinical and manufacturing expenses primarily due to increased patient enrollment in the on-going ESSENCE trial as well as a ramp-up of manufacturing activities for golodirsen, casimersen and our PPMO platform. These increases were partially offset by a ramp-down of clinical trials in eteplirsen primarily because the PROMOVI trial has been fully enrolled;$8.6 million increase in compensation and other personnel expenses primarily due to a net increase in headcount;$6.1 million increase in collaboration cost sharing with Summit on its utrophin platform;$4.1 million increase in preclinical expenses primarily due to the continuing ramp-up of toxicology studies in our PPMO platform as well as golodirsen and casimersen;$4.0 million increase in professional services primarily due to accelerated company growth as a result of expansion of our R&D pipeline;$3.0 million increase in stock-based compensation expense primarily driven by change in headcount as well as achievement of a milestone related to theSeptember 2016 restricted stock awards with performance condition;$2.1 million increase in facility-related expenses due to our continuing expansion efforts; and$1.4 million increase in sponsored research with institutions such asDuke University and Genethon.
Non-GAAP research and development expenses were
Selling, general and administration
Selling general and administrative expenses were
$8.3 million increase in compensation and other personnel expenses primarily due to a net increase in headcount;$5.6 million increase in professional services primarily due to continuing global expansion;$4.2 million increase in stock-based compensation primarily due to an increase in headcount and the achievement of a milestone related to theSeptember 2016 restricted stock awards with performance condition;$4.6 million decrease in restructuring expenses due to the relief of cease-use liabilities as a result of the termination of the rental agreement for our Corvallis facility; and$3.4 million decrease in severance expense as a result of termination of our former CEO inJune 2017 .
Selling general and administrative expenses were
$13.6 million increase in compensation and other personnel expenses primarily due to a net increase in headcount;$12.0 million and$1.2 million increase in professional services and facility related expenses, respectively, primarily due to continuing global expansion;$8.8 million increase in stock-based compensation primarily due to an increase in headcount, the achievement of a milestone related to theSeptember 2016 restricted stock awards granted with a performance condition, as well as the impact of a revised forfeiture rate assumption for equity awards granted to officers and directors;$4.8 million decrease in restructuring expenses associated with our Corvallis facility; and$3.4 million decrease in severance expense as a result of termination of our former CEO inJune 2017 .
Non-GAAP selling, general and administrative expenses were
EXONDYS 51 litigation and license charges
As a result of the execution of the settlement and license agreements with
Amortization of in-licensed rights
Amortization of in-licensed rights was
Other (loss) Income
Gain from sale of Priority Review Voucher
In connection with the completion of the sale of the Priority Review Voucher (PRV) in
Interest (expense) income and other, net
For the three and six months ended
Cash, Cash Equivalents, Investments and Restricted 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 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, restructuring 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, restructuring 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, restructuring 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. Restructuring expenses
The Company believes that adjusting for these items more closely represents the Company’s ongoing operating performance and financial results.
4. 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 relates 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 the aforementioned gain from the sale of the Company’s PRV and up-front and milestone payments.
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 Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit www.sarepta.com.
Forward-Looking Statements
In order to provide Sarepta’s investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “may,” “intends,” “prepares,” “looks,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to Sarepta’s future operations, financial performance and projections, business plans, priorities and development of product candidates including: Sarepta’s vision to become one of the most meaningful precision genetic medicine companies globally with a strong focus on execution against both its near- and long-term range goals; the benefits of EXONDYS 51 and Sarepta’s ability as a fully integrated, commercial-stage genetic medicine company to support its therapies in the community and deliver on its commitments; the transactions with Lacerta providing Sarepta with access to world-leading talent, next-generation tools, and three additional gene therapy programs, one focused on Pompe Disease and two additional CNS-targeted programs, with the purpose of supporting Sarepta’s strategic expansion; the potential of Sarepta’s numerous catalysts to solidify Sarepta as a leader in precision genetic medicine and a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare, genetic-based disease; the potential benefits of the transactions with Lacerta and payments that Sarepta is expected to make in connection with these transactions; Sarepta’s plan to make an equity investment of $30 in Lacerta; Sarepta’s expectation that a SAG will be convened in the fall of 2018 and that a final CHMP decision will be made by year-end 2018; Sarepta’s plan to continue to build internal expertise in all aspects of AAV-based manufacturing while partnering with Brammer Bio to provide scalable best-in-class manufacturing capabilities; Sarepta’s goal of bringing micro-dystrophin gene therapies to the patient community urgently and in sufficient supply; Sarepta’s plan to partner with Brammer Bio to design and build dedicated commercial manufacturing capacity within Brammer Bio’s facility with cutting-edge capabilities; and the expectation that the facility will provide robust manufacturing capacity to support the unusually high demands for systemic administration of the micro-dystrophin therapy for DMD.
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, 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 CHMP may render a negative final decision and we may not be able to obtain regulatory approval for eteplirsen from the EMA; the expected benefits and opportunities related to the transactions with Lacerta may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development; the partnership with Lacerta may not result in any viable treatments suitable for clinical research or commercialization due to a variety of reasons including 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 or may never become commercialized products due to other various reasons including any potential future inability of the parties to fulfill their commitments and obligations under the agreements, including any inability by us to fulfill our financial commitments to Lacerta; the expected benefits and opportunities related to the agreement with Brammer Bio may not be realized or may take longer to realize than expected; Sarepta’s dependence on Brammer Bio 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; if Brammer Bio were to cease providing quality manufacturing and related services to Sarepta, and Sarepta is not able to engage appropriate replacements in a timely manner, Sarepta’s ability to manufacture its gene therapy product candidates in sufficient quality and quantity would adversely affect Sarepta’s various product research, development and commercialization efforts; 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; Sarepta’s ongoing research and development efforts may not result in any viable treatments suitable for commercialization due to a variety of reasons, some of which may be outside of Sarepta’s control, including the results of future research may fail to meet regulatory approval requirements for the safety and efficacy of product candidates, 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 even if Sarepta’s programs result in new commercialized products, Sarepta may not achieve any significant revenues from the sale of such products; 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, 2017 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. Consolidated Statements of Operations (unaudited, in thousands, except per share amounts) |
||||||||||||||||
| For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
|||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product, net | $ | 73,529 | $ | 35,011 | $ | 138,133 | $ | 51,353 | ||||||||
| Total revenues | 73,529 | 35,011 | 138,133 | 51,353 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of sales (excluding amortization of in-licensed rights) | $ | 6,735 | 506 | $ | 12,317 | 729 | ||||||||||
| Research and development | 122,848 | 58,908 | 169,052 | 88,027 | ||||||||||||
| Selling, general and administrative | 47,156 | 36,069 | 90,497 | 62,285 | ||||||||||||
| EXONDYS 51 litigation and license charges | — | 2,839 | — | 2,839 | ||||||||||||
| Amortization of in-licensed rights | 217 | 28 | 433 | 57 | ||||||||||||
| Total costs and expenses | 176,956 | 98,350 | 272,299 | 153,937 | ||||||||||||
| Operating loss | (103,427 | ) | (63,339 | ) | (134,166 | ) | (102,584 | ) | ||||||||
| Other (loss) income: | ||||||||||||||||
| Gain from sale of Priority Review Voucher | — | — | — | 125,000 | ||||||||||||
| Interest (expense) income and other, net | (5,218 | ) | 184 | (9,703 | ) | 519 | ||||||||||
| Other (loss) income | (5,218 | ) | 184 | (9,703 | ) | 125,519 | ||||||||||
| (Loss) income before income tax expense (benefit) | (108,645 | ) | (63,155 | ) | (143,869 | ) | 22,935 | |||||||||
| Income tax expense (benefit) | 622 | (109 | ) | 761 | 1,891 | |||||||||||
| Net (loss) income | (109,267 | ) | (63,046 | ) | (144,630 | ) | 21,044 | |||||||||
| Net (loss) income per share | ||||||||||||||||
| Basic (loss) earnings per share | $ | (1.67 | ) | $ | (1.15 | ) | $ | (2.22 | ) | $ | 0.38 | |||||
| Diluted (loss) earnings per share | $ | (1.67 | ) | $ | (1.15 | ) | $ | (2.22 | ) | $ | 0.37 | |||||
| Weighted average number of shares of common stock used in computing: | ||||||||||||||||
| Basic (loss) earnings per share | 65,484 | 54,976 | 65,060 | 54,913 | ||||||||||||
| Diluted (loss) earnings per share | 65,484 | 54,976 | 65,060 | 56,176 | ||||||||||||
| 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, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| GAAP net (loss) income | $ | (109,267 | ) | $ | (63,046 | ) | $ | (144,630 | ) | $ | 21,044 | |||||
| Interest expense (income), net | 4,689 | (83 | ) | 9,192 | (112 | ) | ||||||||||
| Income tax expense (benefit) | 622 | (109 | ) | 761 | 1,891 | |||||||||||
| Depreciation and amortization expense | 2,873 | 1,772 | 5,125 | 3,409 | ||||||||||||
| Stock-based compensation expense | 15,279 | 10,465 | 25,805 | 16,177 | ||||||||||||
| Restructuring expense | (2,222 | ) | 2,524 | (2,222 | ) | 2,760 | ||||||||||
| Up-front and milestone payments | 60,000 | 22,000 | 60,000 | 22,000 | ||||||||||||
| Gain from sale of Priority Review Voucher | — | — | — | (125,000 | ) | |||||||||||
| Non-GAAP net loss (1) | $ | (28,026 | ) | $ | (26,477 | ) | $ | (45,969 | ) | $ | (57,831 | ) | ||||
| Non GAAP net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.43 | ) | $ | (0.48 | ) | $ | (0.71 | ) | $ | (1.05 | ) | ||||
| Weighted average number of shares of common stock outstanding for computing: | ||||||||||||||||
| Basic and diluted | 65,484 | 54,976 | 65,060 | 54,913 | ||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| GAAP research and development expenses | 122,848 | 58,908 | 169,052 | 88,027 | ||||||||||||
| Up-front and milestone payments | (60,000 | ) | (22,000 | ) | (60,000 | ) | (22,000 | ) | ||||||||
| Stock-based compensation expense | (5,029 | ) | (2,195 | ) | (7,089 | ) | (4,069 | ) | ||||||||
| Depreciation and amortization expense | (853 | ) | (517 | ) | (1,701 | ) | (1,029 | ) | ||||||||
| Restructuring expense | — | (104 | ) | — | (174 | ) | ||||||||||
| Non-GAAP research and development expenses (1) | 56,966 | 34,092 | 100,262 | 60,755 | ||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| GAAP selling, general and administrative expenses | 47,156 | 36,069 | 90,497 | 62,285 | ||||||||||||
| Stock-based compensation expense | (10,250 | ) | (8,270 | ) | (18,716 | ) | (12,108 | ) | ||||||||
| Depreciation and amortization expense | (1,803 | ) | (1,198 | ) | (2,991 | ) | (2,323 | ) | ||||||||
| Restructuring credit (expense) | 2,222 | (2,420 | ) | 2,222 | (2,586 | ) | ||||||||||
| Non-GAAP selling, general and administrative expenses (1) | 37,325 | 24,181 | 71,012 | 45,268 | ||||||||||||
(1) Commencing in the first quarter of 2018, the Company has excluded interest expense (income), net, and depreciation and amortization expense from the computation of its non-GAAP financial measures. The Company has revised prior year presentation in the tables above in order to conform to the current year presentation.
| Sarepta Therapeutics, Inc. Consolidated Balance Sheets (unaudited, in thousands, except share and per share data) |
||||||||
| As of June 30, 2018 |
As of December 31, 2017 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 410,375 | $ | 599,691 | ||||
| Short-term investments | 538,769 | 479,369 | ||||||
| Accounts receivable | 42,985 | 29,468 | ||||||
| Inventory | 104,126 | 83,605 | ||||||
| Other current assets | 42,989 | 36,511 | ||||||
| Total current assets | 1,139,244 | 1,228,644 | ||||||
| Property and equipment, net of accumulated depreciation of $22,124 and $18,022 as of June 30, 2018 and December 31, 2017, respectively |
57,624 | 43,156 | ||||||
| Intangible assets, net of accumulated amortization of $5,100 and $4,145 as of June 30, 2018 and December 31, 2017, respectively |
14,857 | 14,355 | ||||||
| Other assets | 35,435 | 21,809 | ||||||
| Total assets | $ | 1,247,160 | $ | 1,307,964 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 17,382 | $ | 8,467 | ||||
| Accrued expenses | 72,477 | 68,982 | ||||||
| Current portion of long-term debt | 9,514 | 6,175 | ||||||
| Deferred revenue | 3,303 | 3,316 | ||||||
| Other current liabilities | 2,011 | 1,392 | ||||||
| Total current liabilities | 104,687 | 88,332 | ||||||
| Long-term debt | 429,925 | 424,876 | ||||||
| Deferred rent and other | 13,501 | 5,539 | ||||||
| Total liabilities | 548,113 | 518,747 | ||||||
| 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; 66,346,248 and 64,791,670 issued and outstanding at June 30, 2018 and December 31, 2017, respectively |
7 | 6 | ||||||
| Additional paid-in capital | 2,061,039 | 2,006,598 | ||||||
| Accumulated other comprehensive loss | (361 | ) | (379 | ) | ||||
| Accumulated deficit | (1,361,638 | ) | (1,217,008 | ) | ||||
| Total stockholders’ equity | 699,047 | 789,217 | ||||||
| Total liabilities and stockholders’ equity | $ | 1,247,160 | $ | 1,307,964 | ||||
Source: Sarepta Therapeutics, Inc.
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Rachel Hutman, 301-801-5540
rhutman@w2ogroup.com
Source: Sarepta Therapeutics, Inc.
This section of our website may contain dated or archived information which should not be considered current and may no longer be accurate. For current information, you are encouraged to review our most recent official corporate documents on file with the U.S. Securities and Exchange Commission.