Insight on Financial & Corporate Actions - Report on PTC Therapeutics, Inc.

Jul 22, 2015, 09:15 ET from www.aciassociation.com

NEW YORK, July 22, 2015 /PRNewswire/ --

ACI Association has initiated research coverage on PTC Therapeutics, Inc. (NASDAQ: PTCT). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.

Today, membership is open to readers on a complementary basis at the following URL: http://www.aciassociation.com/?c=PTCT

Highlights from our PTCT Report include:

  • Strong First Quarter 2015 Results: In a press release dated May 4, 2015, PTC Therapeutics, Inc. reported about its corporate actions and financial results for the first quarter 2015. During the quarter, total revenues amounted to c. $7.5 million, including $5.1 million in Translarna product sales revenue and $2.4 million in grants and collaborations revenue, compared to total revenue of c. $9.2 million reported in Q1 2014. This decrease in total revenue was due to recognition of a $7.5 million milestone payment from Roche in Q1 2014 related to PTC Therapeutics' SMA collaboration, partially offset by Translarna product sales. Net loss came in at $37.9 million compared to a net loss of $14.1 million in Q1 2014.
  • Ongoing clinical trials lifts R & D expenditure in Q1 2015 - The Company's Research and development expenses were $27.9 million, including $4.7 million in non-cash, stock-based compensation expense, compared to $15.9 million in Q1 2014, including $1.9 million in non-cash, stock-based compensation expense. The Company has attributed this increase in R&D expense to additional costs incurred during the ongoing clinical trials and supply chain activities in support of the launch of Translarna as well as in conjunction with its expanding clinical-stage pipeline.
  • Expected Trial Results and Planned Commercial Launch- On Operational front, the Company highlighted that it aims to release the top-line data from its ongoing Phase 3 ACT DMD trial by Q4 2015 and it expects the results to form the basis for finalizing its New Drug Application for the approval of Translarna in nonsense mutation DMD. Additionally, the Company has also begun working upon its US commercial team and infrastructure in preparation for a potential US launch in the first half of 2016. PTC Therapeutics also aims to file for approval of Translarna for the treatment of nonsense mutation cystic fibrosis in the EU in the second half of 2015.
  • Clinical trials on track - PTC plans to initiate a Phase 2 proof-of-concept study in nonsense mutation aniridia by the end of 2015. PTC is also commencing a proof-of-concept Phase 2 study of Translarna in nonsense mutation MPS I in addition to its ongoingPhase 3 trials in nonsense mutation DMD and nonsense mutation CF. According to the Company, due to its mechanism of action, Translarna has the potential to address numerous disorders caused by a nonsense mutation. The Company continues to evaluate additional indications to fully capture Translarna's potential.

To find out how this influences our rating on PTC Therapeutics, Inc., read the full report in its entirely here: http://www.aciassociation.com/?c=PTCT

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