Full Press Release Details
SOUTH PLAINFIELD, N.J. , Aug. 7, 2014 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the second quarter ended June 30, 2014.
"This has been an exciting quarter for PTC. In May we received a positive opinion from the CHMP for marketing approval for Translarna™ (ataluren) an investigational new drug in the US, for nonsense mutation Duchenne muscular dystrophy and we recently received the approval from the European Commission granting the conditional marketing authorization. It is an honor to bring the world's first therapy for Duchenne muscular dystrophy to patients who have been waiting too long for a treatment. We are actively focused on providing Translarna to patients as quickly as possible and are working aggressively to prepare for launch across the EU," stated Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "In addition to our efforts in nmDMD, we recently initiated our confirmatory Phase 3 clinical trial in nonsense mutation cystic fibrosis and it is our goal to initiate a Phase 2 proof-of-concept study for Translarna in a new indication, MPS I caused by a nonsense mutation, later this year. We expect the second half of the year will be a transformative time at PTC, as we expand our global commercial organization focused on our mission of bringing new therapies to patients with rare and neglected disorders."
Corporate Highlights:
Second Quarter 2014 Financial Highlights:
Today's Conference Call and Webcast Reminder The PTC management team will host a conference call to discuss the company's financial results and recent and upcoming developments today, Thursday, August 7, 2014 , at 8:30 a.m. ET . The call 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 75347535.
The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors Relations" section of the company's website at ir.ptcbio.com . A replay of the webcast will be archived on the PTC website for 30 days following the call.
About PTC Therapeutics, Inc. PTC is a biopharmaceutical company focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders, oncology and infectious diseases. PTC has developed proprietary technologies that it applies in its drug discovery activities and in collaborations with leading biopharmaceutical companies. For more information on the company, please visit our website www.ptcbio.com
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, including statements regarding the future expectations, plans and prospects for PTC; the timing and scope of our commercial launch; our Phase 3 clinical trials for ataluren in nmDMD and nmCF; our Phase 2 proof of concept trial in MPS I; our collaboration in SMA with Roche and the SMA Foundation; our current and planned regulatory filings; our earlier stage programs including BMI1 and our antibacterial program; our strategy, future operations, future financial position, future revenues or projected costs; the development of and potential market for PTC's product candidates; and objectives of management, are forward-looking statements. 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.
Our actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements we make as a result of a variety of risks and uncertainties, including those related to the initiation and conduct of clinical trials, availability of data from clinical trials, expectations for regulatory approvals, our scientific approach and general development progress, the availability or commercial potential of our product candidates and the factors discussed in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission. You are urged to carefully consider all such factors. The forward-looking statements contained herein represent PTC's views only as of the date of this press release, and we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this release except as required by law.
| PTC Therapeutics, Inc. | |||||||
| Statements of Operations | |||||||
| (In thousands, except per share data) | |||||||
| Three Months Ended | Six Months Ended | ||||||
| June 30, | June 30, | ||||||
| 2014 | 2013 | 2014 | 2013 | ||||
| Revenues: | |||||||
| Collaboration revenue | $1,418 | $5,868 | $10,565 | $11,940 | |||
| Grant revenue | 259 | 986 | 329 | 2,056 | |||
| Total revenues | 1,677 | 6,854 | 10,894 | 13,996 | |||
| Operating expenses: | |||||||
| Research and development (1) | 18,313 | 14,712 | 34,202 | 25,969 | |||
| General and administrative (1) | 8,733 | 6,595 | 16,273 | 11,056 | |||
| Total operating expenses | 27,046 | 21,307 | 50,475 | 37,025 | |||
| Loss from operations | (25,369) | (14,453) | (39,581) | (23,029) | |||
| Interest income (expense), net | 248 | (114) | 419 | (6,276) | |||
| Other income (expense), net | 17 | (19) | (40) | 34 | |||
| Net loss | (25,104) | (14,586) | (39,202) | (29,271) | |||
| Deemed dividend | — | — | — | (18,249) | |||
| Gain on exchange of convertible preferred stock in | |||||||
| connection with recapitalization | — | — | — | 3,391 | |||
| Net loss attributable to common shareholders | ($25,104) | ($14,586) | ($39,202) | ($44,129) | |||
| Weighted-average shares outstanding (in shares): | |||||||
| Basic and diluted | 29,332,227 | 2,648,832 | 27,976,847 | 1,326,679 | |||
| Net loss per share applicable to common | |||||||
| stockholders - basic and diluted (in dollars per share) | ($0.86) | ($5.51) | ($1.40) | ($33.26) | |||
| (1) Non-cash share-based compensation expense | |||||||
| included in operating expenses are as follows: | |||||||
| Research and development | $2,209 | $1,107 | $4,153 | $1,364 | |||
| General and administrative | 2,069 | 774 | 3,830 | 1,138 | |||
| Total share-based compensation expense | $4,278 | $1,881 | $7,983 | $2,502 |
| PTC Therapeutics, Inc. | |||
| Summary Balance Sheet | |||
| (In thousands, except share amounts) | |||
| June 30, | December 31, | ||
| 2014 | 2013 | ||
| Cash, cash equivalents and marketable securities | $226,859 | $142,467 | |
| Total assets | $237,558 | $151,903 | |
| Total debt | — | 49 | |
| Total deferred revenue | 242 | 878 | |
| Total liabilities | $13,802 | $15,361 | |
| Total stockholders' equity (29,340,577 and 23,803,282 common shares | |||
| issued and outstanding at June 30, 2014 and December 31, 2013, respectively) | 223,756 | 136,542 | |
| Total liabilities and stockholders' equity | $237,558 | $151,903 |
SOURCE PTC Therapeutics, Inc.