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Spark Therapeutics, Inc. (ONCE) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Spark Therapeutics, Inc.

CIK: 1609351 Ticker: ONCE


Exhibit 99.1
 
 
Spark Therapeutics Reports 2018 Financial Results and Recent Business Progress

PHILADELPHIA, Feb. 19, 2019
(GLOBE NEWSWIRE)- Spark Therapeutics (NASDAQ: ONCE), a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, announced today corporate and financial results for 2018 and recent business progress.

“In 2018, we successfully launched LUXTURNA® (voretigene neparvovec-rzyl) in the U.S. and have demonstrated first-of-its-kind commercial expertise, including establishing the ability to deliver a gene therapy while securing patient access. We also obtained marketing authorization for LUXTURNA in the EU,” said Jeffrey D. Marrazzo, chief executive officer of Spark Therapeutics. “Additionally, we advanced our global hemophilia A franchise, with SPK-8011 entering Phase 3 and SPK-8016 entering Phase 1/2 clinical trials. In parallel, we proceeded with preparations to have two more investigational gene therapies ready for clinical trials in 2019, including SPK-3006 for Pompe disease.”

“Throughout this progress, we have built unique competencies in the discovery, development and delivery of genetic medicines that guide our portfolio strategy - from how we discover and develop gene therapies, to how we select targets and prioritize our programs, to how we manufacture and commercialize these novel therapies globally,” said Marrazzo. “We believe these competencies increase our ability to successfully break barriers by transforming the research in our labs into life-altering gene therapy products for patients and position us well for continued growth and success.

2018 and recent business highlights
Launched LUXTURNA, the first gene therapy for a genetic disease and only pharmacologic treatment for inherited retinal disease in the U.S. and secured EU marketing authorization
Pioneered innovative pricing and distribution models in U.S. that secured access for patients and families
Shipped 75 vials of LUXTURNA in the U.S.
Entered into a licensing and supply agreement granting Novartis Pharmaceuticals exclusive rights to commercialize LUXTURNA in markets outside the U.S.

Expanded hemophilia portfolio to include multiple investigational gene therapies, with three programs now in clinical trials
Presented updated preliminary data, with a Nov. 2, 2018, data cutoff, on the first 12 participants in the ongoing Phase 1/2 clinical trial of SPK-8011 in hemophilia A at an oral presentation at the American Society of Hematology annual meeting
No inhibitors, no thrombotic events and no persistent or unresolved transaminase elevations were observed across a cumulative 9.7 years of data follow-up



The following information was filed by Spark Therapeutics, Inc. (ONCE) on Tuesday, February 19, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Spark Therapeutics, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations And Other Comprehensive Income (Loss)
Consolidated Statements Of Stockholders' Equity
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Schedule Of Accrued Expenses (Details)
Background
Background - Additional Information (Details)
Business Acquisition Of Genable And Impairment Of Acquired In-Process Research And Development
Business Acquisition Of Genable And Impairment Of Acquired In-Process Research And Development (Tables)
Business Acquisition Of Genable And Impairment Of Acquired In-Process Research And Development - Additional Information (Details)
Business Acquisition Of Genable And Impairment Of Acquired In-Process Research And Development - Allocation Of Purchase Price (Details)
Collaboration And License Agreements
Collaboration And License Agreements Collaboration And License Agreements - Novartis (Details)
Collaboration And License Agreements Collaboration And License Agreements - Pfizer (Details)
Collaboration And License Agreements Collaboration And License Agreements - Selecta (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Debt
Debt (Tables)
Debt - Additional Information (Details)
Debt - Schedule Of Debt (Details)
Development-Stage Risks
Development-Stage Risks - Additional Information (Details)
Fair Value Of Financial Instruments
Fair Value Of Financial Instruments (Tables)
Fair Value Of Financial Instruments - Summary Of Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
Income Taxes (Tables)
Income Taxes - Components Of Income Tax Expense (Benefit) (Details)
Income Taxes - Deferred Tax Assets (Details)
Income Taxes - Effective Rate Reconciliation (Details)
Income Taxes - Loss From Domestic And Foreign Operations (Details)
Income Taxes - Narrative (Details)
Income Taxes - Unrecognized Tax Benefits (Details)
Income Taxes Income Taxes
Inventory
Inventory (Details)
Inventory (Tables)
Marketable Securities
Marketable Securities (Tables)
Marketable Securities - Schedule Of Available-For-Sale Securities (Details)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Schedule Of Property And Equipment, Net (Details)
Related-Party Transactions
Related-Party Transactions - Additional Information (Details)
Sale Of Priority Review Voucher Sale Of Priority Review Voucher
Sale Of Priority Review Voucher Sale Of Priority Review Voucher (Details)
Selected Quarterly Financial Data (Unaudited)
Selected Quarterly Financial Data (Unaudited) (Details)
Selected Quarterly Financial Data (Unaudited) (Tables)
Stock Incentive Plans
Stock Incentive Plans (Tables)
Stock Incentive Plans - Additional Information (Details)
Stock Incentive Plans - Compensation Expense (Details)
Stock Incentive Plans - Summary Of Restricted Common Stock Activity (Details)
Stock Incentive Plans - Summary Of Stock Option Activity (Details)
Stock Incentive Plans - Summary Of Weighted-Average Assumptions (Details)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information (Details)
Stockholders' Equity - Summary Of Restricted Stock Activity (Details)
Subsequent Events
Subsequent Events - Additional Information (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Accumulated Other Comprehensive Loss (Details)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Schedule Of Antidilutive Securities Excluded From Computation Of Diluted Weighted Average Shares Outstanding (Details)
Ticker: ONCE
CIK: 1609351
Form Type: 10-K Annual Report
Accession Number: 0001609351-19-000042
Submitted to the SEC: Thu Feb 28 2019 5:00:36 PM EST
Accepted by the SEC: Thu Feb 28 2019
Period: Monday, December 31, 2018
Industry: Biological Products No Disgnostic Substances

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