Full Press Release Details
SOUTH PLAINFIELD, N.J. , Nov. 9, 2015 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the third quarter ending September 30, 2015 .
"We recently reported results from our Phase 3 ACT DMD clinical trial and are now actively finalizing our regulatory submissions to both the FDA and EMA, which we plan to complete by the end of this year," said Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "Our ongoing launch of Translarna for Duchenne muscular dystrophy across Europe and other parts of the world continues to perform well, and based on the consistently positive feedback we are receiving from key opinion leaders, physicians, and patient advocacy groups regarding our ACT DMD results, we expect this momentum to build."
Key Third Quarter 2015 Corporate Highlights:
Upcoming Events:
PTC will participate in the following conferences in the fourth quarter:
Third Quarter 2015 Financial Highlights:
| PTC Therapeutics, Inc. | |||||||
| Consolidated Statements of Operations | |||||||
| (In thousands, except per share data) | |||||||
| Three Months Ended | Nine Months Ended | ||||||
| September 30, | September 30, | ||||||
| 2015 | 2014 | 2015 | 2014 | ||||
| Revenues: | |||||||
| Net product revenue | $ 9,772 | $ 81 | $ 21,002 | $ 81 | |||
| Collaboration revenue | 2 | 716 | 547 | 11,280 | |||
| Grant revenue | 2 | 897 | 2,483 | 1,226 | |||
| Total revenues | 9,776 | 1,694 | 24,032 | 12,587 | |||
| Operating expenses: | |||||||
| Research and development (1) | 30,640 | 18,765 | 86,768 | 52,967 | |||
| Selling, general and administrative (1) | 21,368 | 10,530 | 56,193 | 26,803 | |||
| Total operating expenses | 52,008 | 29,295 | 142,961 | 79,770 | |||
| Loss from operations | (42,232) | (27,601) | (118,929) | (67,183) | |||
| Interest (expense)/income | (852) | 354 | 170 | 774 | |||
| Other expense, net | (51) | (35) | (507) | (75) | |||
| Loss before income tax expense | (43,135) | (27,282) | (119,266) | (66,484) | |||
| Income tax expense | (88) | — | (233) | — | |||
| Net loss | $ (43,223) | $ (27,282) | $ (119,499) | $ (66,484) | |||
| Weighted-average shares outstanding (in shares): | |||||||
| Basic and diluted | 33,908,853 | 29,351,693 | 33,528,833 | 28,441,827 | |||
| Net loss per share - basic and diluted (in dollars per share) | $ (1.27) | $ (0.93) | $ (3.56) | $ (2.34) | |||
| (1) Non-cash share-based compensation expense | |||||||
| included in operating expenses are as follows: | |||||||
| Research and development | $ 3,828 | $ 2,363 | $ 12,452 | $ 6,517 | |||
| Selling, general and administrative | 4,226 | 2,258 | 13,678 | 6,088 | |||
| Total share-based compensation expense | $ 8,054 | $ 4,621 | $ 26,130 | $ 12,605 |
| PTC Therapeutics, Inc. | |||
| Summary Consolidated Balance Sheet | |||
| (In thousands, except share amounts) | |||
| September 30, | December 31, | ||
| 2015 | 2014 | ||
| Cash, cash equivalents and marketable securities | $ 371,521 | $ 315,241 | |
| Total assets | $ 396,100 | $ 333,219 | |
| Total debt | $ 93,198 | $ - | |
| Total deferred revenue | - | 3,354 | |
| Total liabilities | $ 126,949 | $ 34,752 | |
| Total stockholders' equity (33,915,059 and 32,898,392 common shares | |||
| issued and outstanding at September 30, 2015 and December 31, 2014, respectively) | $ 269,151 | $ 298,467 | |
| Total liabilities and stockholders' equity | $ 396,100 | $ 333,219 |
Today's Conference Call and Webcast Reminder Today's call will take place at 4:30 p.m. (ET) and can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 60395335. The accompanying slide presentation will be posted on the investor relations section of the PTC website at www.ptcbio.com .
A webcast replay of the call will be available approximately two hours after completion of the call. The webcast and slide presentation will be archived on the company's website for two weeks.
About PTC Therapeutics, Inc. PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of orally administered, proprietary small molecule drugs targeting an area of RNA biology we refer to as post-transcriptional control. Post-transcriptional control processes are the regulatory events that occur in cells during and after a messenger RNA, or mRNA, molecule is copied from DNA through the transcription process. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders, oncology and infectious diseases. PTC has discovered all of its compounds currently under development using its proprietary technologies. PTC plans to continue to develop these compounds both on its own and through selective collaboration arrangements with leading pharmaceutical and biotechnology companies. For more information on the company, please visit our website www.ptcbio.com
About Translarna™ (ataluren) Translarna, discovered and developed by PTC Therapeutics, Inc., is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. A nonsense mutation is an alteration in the genetic code that prematurely halts the synthesis of an essential protein. The resulting disorder is determined by which protein cannot be expressed in its entirety and is no longer functional, such as dystrophin in Duchenne muscular dystrophy. Translarna is licensed in the European Economic Area for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. Translarna is an investigational new drug in the United States . The development of Translarna has been supported by grants from Cystic Fibrosis Foundation Therapeutics Inc. (the nonprofit affiliate of the Cystic Fibrosis Foundation); Muscular Dystrophy Association; FDA's Office of Orphan Products Development; National Center for Research Resources; National Heart, Lung, and Blood Institute; and Parent Project Muscular Dystrophy.
For More Information Please Contact :
Investors: Emily Hill +1 (908) 912-9327 [email protected]
Media: Justine O'Malley +1 (908) 912-9551 [email protected]
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements, other than those of historical fact, contained in this release, are forward-looking statements, including statements regarding the future expectations, plans and prospects for PTC; the timing of PTC's planned regulatory filings, including with the FDA, the EMA and other regulatory bodies outside of the United States and European Economic Area, or EEA; the clinical utility and potential advantages of Translarna; the timing and scope of PTC's commercial and early access program launches; the rate and degree of market acceptance; PTC's estimates regarding the potential market opportunity for Translarna, including the size of eligible patient populations and PTC's ability to identify such patients; the timing, results and conduct of PTC's clinical trials and studies of Translarna for the treatment CF, MPS I and aniridia caused by nonsense mutation, as well its Phase 2 MOONFISH study under its SMA collaboration with Roche and the SMA Foundation and its Phase 1 study under its cancer stem cell program, including statements regarding the timing of initiation, evaluation, enrollment and completion of the trials and studies and the period during which the results of the trials and studies will become available; our strategy, future operations, future financial position, future revenues or projected costs; and objectives of management. Other forward-looking statements may be identified by the words "plan," "guidance," "anticipate," "believe," "estimate," "expect," "intend," "may," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.
SOURCE PTC Therapeutics, Inc.