Spark Therapeutics (ONCE) Tops Q3 EPS by 74c, Miss on Revenues

Spark Therapeutics (NASDAQ: ONCE) reported Q3 EPS of ($1.07), $0.74 better than the analyst estimate of ($1.81). Revenue for the quarter came in at $1.3 million versus the consensus estimate of $1.46 million.

Additional highlights

Advanced investigational LUXTURNA for the treatment of biallelic RPE65-mediated IRD:

• U.S. Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee unanimously recommended (16-0) approval of LUXTURNA
• Completed FDA pre-approval inspections with no critical observations cited
• Marketing Authorization Application (MAA) has been validated by European Medicines Agency (EMA)

Progressed hemophilia programs:

• Dosed two additional participants in SPK-8011 Phase 1/2 clinical trial - a second participant at 1e12 vg/kg and a first participant at a third dose of 2e12 vg/kg, bringing the number of participants enrolled to five
• SPK-8011 data and SPK-9001 interim data accepted for oral presentations at American Society of Hematology (ASH) annual meeting on Dec. 11, 2017
• Entered into an amendment to the license agreement for SPK-9001 with Pfizer; will receive from Pfizer initial $10 million cash payment and up to an additional $15 million in potential milestone payments upon completion of certain transition activities

Bolstered human capital, technology platform and financial position as we expand our fully integrated organization:

• Entered into a licensing agreement with Genethon for the development and commercialization of an adeno-associated viral (AAV) gene therapy targeting the liver to address a rare genetic disease
• Appointed Federico Mingozzi, Ph.D., as chief scientific officer
• Strong balance sheet with $574.9 million in cash, cash equivalents and marketable securities as of Sept. 30, 2017

For earnings history and earnings-related data on Spark Therapeutics (ONCE) click here.

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