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Press Release

PTC Therapeutics Reports Second Quarter 2017 Financial Results and Provides Corporate Update

PTC Therapeutics
Posted on: 09 Aug 17

SOUTH PLAINFIELD, N.J., Aug. 8, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the second quarter ending June 30, 2017.

"Since our founding nearly 20 years ago, it has been our mission to provide treatments to patients living with rare diseases who have limited treatment options," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "I am proud to have introduced Translarna, the first therapy for nonsense mutation Duchenne muscular dystrophy patients and we remain dedicated to working with patients and their families to bring Translarna to the U.S. We are also pleased with the successful early launch of EMFLAZA. Consistent with our mission, we are working to ensure broad access to EMFLAZA to all eligible Duchenne patients regardless of financial or insurance status."

Second Quarter Financial Highlights:

Translarna net product sales were $45.8 million for the second quarter of 2017, representing 197% growth over $15.4 million reported in the second quarter of 2016.

EMFLAZA net product sales were $2.1 million for the second quarter of 2017.

Total revenues for the second quarter of 2017 were $48.0 million compared to $15.6 million in the same period of 2016. The change in total revenue was a result of the expanded commercial launch of Translarna and the successful U.S. EMFLAZA launch.

GAAP R&D expenses were $30.8 million for the second quarter of 2017 compared to $28.8 million for the same period in 2016. Non-GAAP R&D expenses were $26.9 million for the second quarter of 2017, excluding $3.9 million in non-cash, stock-based compensation expense, compared to $24.6 million for the same period in 2016, excluding $4.1 million in non-cash, stock-based compensation expense and one-time restructuring costs of $0.1 million. The increase in R&D expense for the second quarter of 2017 as compared to the prior year period was primarily due to start-up of clinical activities and regulatory spend, partially offset by the decreased costs due to the completion of our CF program at the end of 2016.

GAAP SG&A expenses were $28.9 million for the second quarter of 2017 compared to $23.4 million for the same period in 2016. Non-GAAP SG&A expenses were $24.9 million for the second quarter of 2017, excluding $4.0 million in non-cash, stock-based compensation expense, compared to $18.3 million for the same period in 2016, excluding $4.6 million in non-cash, stock-based compensation expense and one-time restructuring costs of $0.4 million. The increase in SG&A expenses primarily related to the expansion of the U.S. commercial sales team in support of the launch of EMFLAZA.

Net interest expense for the second quarter of 2017 was $3.0 million compared to net interest expense of $2.1 million in the same period in 2016. The increase in net interest expense is primarily a result of increased interest expense related to the $40 million secured loan facility which we closed during the quarter partially offset by reduced interest income from investments.

Net loss for the second quarter of 2017 was $17.5 million compared to a net loss of $38.9 million for the same period in 2016.

Cash, cash equivalents, and marketable securities totaled approximately $181.1 million at June 30, 2017 compared to approximately $231.7 million at December 31, 2016.

Shares issued and outstanding as of June 30, 2017, were 41.3 million, which includes 0.1 million shares of unvested restricted stock awards.

2017 Guidance:

Translarna net sales for 2017 are now anticipated to be between $120 and $140 million, an increase from prior guidance of $115 to $130 million. PTC anticipates EMFLAZA net sales for 2017 to be between $15 and $20 million. PTC also anticipates a $20 million milestone payment in 2017 related to the SMA program for total 2017 revenues between $155 and $180 million.

GAAP operating expenses for the 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 million and $220 million. These expenses will be primarily in support of the commercial availability of Translarna globally, the commercial launch of EMFLAZA in the U.S. and the continued research and clinical development of other product pipeline candidates.

PTC expects to end 2017 with over $120 million of cash and cash equivalents.

Key Second Quarter and Other Corporate Highlights:

EMFLAZA™ for the treatment of Duchenne muscular dystrophy successfully launched in the U.S. with establishment of EMFLAZACares Program. PTC has successfully launched EMFLAZA in the U.S. with over 1,200 patients receiving therapy only 12 weeks into the launch. We estimate that there are 9,000 Duchenne patients in the U.S. over the age of five. EMFLAZACares is a program designed to enable all eligible patients to have access to EMFLAZA regardless of financial or insurance status. Based on progress to date, we are raising our 2017 guidance to $15-20M from $5-10M.
 

Translarna™ revenue of $45.8 M in second quarter, which represents a 197% growth over 2Q2016. PTC continues to expand on its strong global footprint in Duchenne muscular dystrophy, with sales generated in over 25 countries. Market access discussions regarding funding on a country-by-country basis are ongoing. This strong performance reflects continued uptake, sustainable pricing levels, and high (> 90%) compliance to treatment.
 

NDA for Translarna under FDA review with PDUFA date of October 24, 2017. The FDA has assigned the New Drug Application (NDA) for ataluren (Translarna™) a Prescription Drug User Fee Act (PDUFA) date of October 24, 2017. The company is preparing for the Advisory Committee Meeting, which is tentatively scheduled for September 28, 2017.
 

SMA clinical program on track to advance to a pivotal phase in the second half of 2017. The spinal muscular atrophy (SMA) program, a joint collaboration with Roche and the SMA Foundation, is expected to advance into pivotal studies in the second half of 2017. Commencement of the pivotal portion of either study will trigger a $20 million milestone payment to PTC from Roche. Preliminary data from the first cohort of the SUNFISH trial was presented at the CureSMA Conference and demonstrated a dose dependent increase up to 400% in SMN2 transcript. In addition, no toxicities requiring patients' withdrawal had been observed in the clinic to date.

Non-GAAP Financial Measures:
In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial measures exclude stock-based compensation expense and one-time restructuring expenses relating to the reorganization of operations intended to improve efficiency and better align costs and employment structure with PTC's strategic plans. These non-GAAP financial measures are provided as a complement to results reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management's opinion, these non-GAAP financial measures are useful to investors and other users of PTC's financial statements by providing greater transparency into the operating performance at PTC and the company's future outlook. Quantitative reconciliations of GAAP financial measures are included in the tables below.

For more information:
www.prnewswire.com/news-releases/ptc-therapeutics-reports-second-quarter-2017-financial-results-and-provides-corporate-update-300501432.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 09/08/2017

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