PTC Therapeutics Reports First Quarter 2017 Financial Results And Provides Corporate Update

SOUTH PLAINFIELD, N.J., May 8, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the first quarter ending March 31, 2017.

“We are thrilled to bring EMFLAZA to Duchenne muscular dystrophy patients in the United States,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. “The acquisition of EMFLAZA supports our commitment to providing new treatment options for Duchenne patients. We plan to launch EMFLAZA in the coming weeks and are focused on providing access to all eligible patients. We are also pleased with Translarna’s continued sales growth outside the U.S. with another strong quarter. With Translarna and EMFLAZA, we now have two of the three approved Duchenne drugs globally.”

First Quarter Financial Highlights:

• Translarna net product sales were $26.4 million for the first quarter of 2017, representing 40% growth over $18.9 million reported in the first quarter of 2016.
• Total revenues for the first quarter of 2017 were $26.5 million compared to $18.9 million in the same period of 2016. The change in total revenue was a result of the expanded commercial launch of Translarna.
• GAAP R&D expenses were $27.4 million for the first quarter of 2017 compared to $31.4 million for the same period in 2016. Non-GAAP R&D expenses were $22.9 million for the first quarter of 2017, excluding $4.5 million in non-cash, stock-based compensation expense, compared to $26.4 million for the same period in 2016, excluding $4.3 million in non-cash, stock-based compensation expense and one-time restructuring costs of $0.7 million. The decrease in R&D expense for the first quarter of 2017 as compared to the prior year period was primarily due to the completion of our ACT CF study at the end of 2016 and the ongoing reduction of clinical trial expenses.
• GAAP SG&A expenses were $25.5 million for the first quarter of 2017 compared to $25.9 million for the same period in 2016. Non-GAAP SG&A expenses were $20.9 million for the first quarter of 2017, excluding $4.6 million in non-cash, stock-based compensation expense, compared to $20.2 million for the same period in 2016, excluding $4.6 million in non-cash, stock-based compensation expense and one-time restructuring costs of $1.2 million. SG&A expenses were relatively flat for the first quarter of 2017 as compared to the same period in 2016.
• Net interest expense for the first quarter of 2017 was $2.2 million compared to net interest expense of $2.0 million in the same period in 2016. The increase in net interest expense is primarily a result of reduced interest income from investments.
• Net loss for the first quarter of 2017 was $29.1 million compared to a net loss of $41.2 million for the same period in 2016.
• Cash, cash equivalents, and marketable securities totaled approximately $202.6 million at March 31, 2017 compared to approximately $231.7 million at December 31, 2016.
• Shares issued and outstanding as of March 31, 2017 were 34.6 million, which includes 0.3 million shares of unvested restricted stock.

2017 Guidance:

• Translarna net sales for 2017 are now anticipated to be between $115 and $130 million, an increase from prior guidance of $105 to $125 million. This guidance assumes the current exchange rates and the continued commercial expansion for Translarna in nmDMD outside of the U.S. Taking into account the time to achieve reimbursement and other launch-related factors, PTC anticipates EMFLAZA net sales for 2017 to be between $5 and $10 million. PTC also anticipates a potential $20 million milestone payment in 2017 related to the SMA program for total 2017 revenues between $120 and $160 million.
• GAAP operating expenses for full year 2017 are anticipated to be between $250 to $260 million. Excluding estimated non-cash, stock-based compensation expense of approximately $40 million, full year 2017 non-GAAP operating expenses are anticipated to be between $210 and $220 million. These operating expenses are expected to be primarily in support of the commercial availability of Translarna outside of the U.S. and in support of the pending commercial launch of EMFLAZA in the U.S., as well as the continued research and clinical development of other product pipeline candidates.
• PTC recently closed on a $60 million senior secured term loan facility with MidCap Financial, of which $40 million was drawn at close. As a result of the $75 million in cash utilized in the EMFLAZA acquisition, partially offset by the $40 million draw-down of term-loan financing from MidCap Financial, PTC now expects to end 2017 with cash and cash equivalents of approximately $100 million.

Key First Quarter and other Corporate Highlights:

• Commercial launch of EMFLAZA for the treatment of Duchenne muscular dystrophy. PTC is preparing for the commercial launch of EMFLAZA in the U.S., which is expected to begin in the coming weeks.

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