Full Press Release Details
SOUTH PLAINFIELD, N.J. , Feb. 27, 2015 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2014 .
"2014 was a transformative year for PTC. We are now a growing commercial-stage biopharma company, focused on delivering and developing RNA-targeted therapies in the rare disease space," stated Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "We are proud to bring the first treatment for Duchenne muscular dystrophy to patients who suffer from this devastating disorder. Concurrent with our ongoing launch activities in Europe and around the world, we are beginning to build out our commercial infrastructure in the US in preparation for a potential launch in 2016. We are equally focused on bringing additional innovative therapies to patients by moving our earlier stage pipeline forward. Importantly, we completed two successful public equity financings in 2014, providing us with a strong cash position to advance our ongoing commercial and clinical efforts."
Key 2014 Achievements:
Upcoming Events:
PTC will participate in the following conferences in the first quarter:
Fourth Quarter and Full year 2014 Financial Highlights:
| PTC Therapeutics, Inc. | |||||||
| Consolidated Statements of Operations | |||||||
| (In thousands, except per share data) | |||||||
| Three Months Ended | Twelve Months Ended | ||||||
| December 31, | December 31, | ||||||
| 2014 | 2013 | 2014 | 2013 | ||||
| Revenues: | |||||||
| Net product revenue | $636 | — | $717 | — | |||
| Collaboration revenue | 10,966 | 3,931 | 22,246 | 31,326 | |||
| Grant revenue | 1,056 | 480 | 2,282 | 3,370 | |||
| Total revenues | 12,658 | 4,411 | 25,245 | 34,696 | |||
| Operating expenses: | |||||||
| Research and development (1) | 26,871 | 15,020 | 79,838 | 54,875 | |||
| General and administrative (1) | 18,017 | 7,483 | 44,820 | 25,219 | |||
| Total operating expenses | 44,888 | 22,503 | 124,658 | 80,094 | |||
| Loss from operations | (32,230) | (18,092) | (99,413) | (45,398) | |||
| Interest income (expense), net | 406 | 166 | 1,180 | (6,084) | |||
| Loss on extinguishment of debt | — | — | — | (130) | |||
| Other income (expense), net | (138) | 41 | (213) | 38 | |||
| Loss from operations before tax benefit | (31,962) | (17,885) | (98,446) | (51,574) | |||
| Net tax benefit | 4,693 | — | 4,693 | — | |||
| Net loss | (27,269) | (17,885) | (93,753) | (51,574) | |||
| Deemed dividend | — | — | — | (18,249) | |||
| Gain on exchange of convertible preferred stock in | — | ||||||
| connection with recapitalization | — | — | — | 3,391 | |||
| Net loss attributable to common shareholders | ($27,269) | ($17,885) | ($93,753) | ($66,432) | |||
| Weighted-average shares outstanding (in shares): | |||||||
| Basic and diluted | 32,274,729 | 23,803,282 | 31,565,310 | 12,829,411 | |||
| Net loss per share applicable to common | |||||||
| stockholders - basic and diluted (in dollars per share) | ($0.84) | ($0.75) | ($2.97) | ($5.18) | |||
| (1) Non-cash share-based compensation expense | |||||||
| included in operating expenses are as follows: | |||||||
| Research and development | $3,221 | $1,577 | $9,739 | $4,312 | |||
| General and administrative | 3,483 | 1,708 | 9,571 | 4,115 | |||
| Total share-based compensation expense | $6,704 | $3,285 | $19,310 | $8,427 |
| PTC Therapeutics, Inc. | |||
| Consolidated Summary Balance Sheet | |||
| (In thousands, except share amounts) | |||
| December 31, | December 31, | ||
| 2014 | 2013 | ||
| Cash, cash equivalents and marketable securities | $315,241 | $142,467 | |
| Total assets | $333,219 | $151,903 | |
| Total debt | - | 49 | |
| Total deferred revenue | 3,354 | 878 | |
| Total liabilities | $34,752 | $15,361 | |
| Total stockholders' equity (32,898,392 and 23,803,282 common shares issued and outstanding at December 31, 2014 and December 31, 2013, respectively) | |||
| 298,467 | 136,542 | ||
| Total liabilities and stockholders' equity | $333,219 | $151,903 |
Today's Conference Call and Webcast Reminder 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 85749873.
A live, listen-only webcast of the conference call can be accessed 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 and 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 molecule is copied from DNA through the transcription process. PTC has received conditional marketing authorization in the European Economic Area for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. 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
For More Information Please Contact : Investors: Emily Hill +1 (908) 912-9327 [email protected]
Media: Jane Baj +1 (908) 912-9167 [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, including statements regarding the future expectations, plans and prospects for PTC; the timing and scope of PTC's commercial and early access program launches; the rate and degree of market acceptance and clinical utility of Translarna; 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 and conduct of PTC's clinical trials of Translarna for the treatment of nmDMD, nmCF and nmMPS I, as well as trials in its SMA collaboration with Roche and the SMA Foundation and its cancer stem cell program, including statements regarding the timing of initiation, enrollment and completion of the trials and the period during which the results of the trials will become available; our current and planned regulatory filings, including with the FDA and in the European Union; our strategy, future operations, future financial position, future revenues or projected costs; 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.
PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to its ability to commercialize Translarna in general and specifically as a treatment for nmDMD, including its ability to successfully negotiate favorable pricing and reimbursement processes on a timely basis in the countries in which it may obtain regulatory approval, including the countries in the European Economic Area; the initiation, conduct and availability of data from clinical trials; expectations for regulatory approvals; PTC's scientific approach and general development progress; the eligible patient base and commercial potential of Translarna and PTC's other product candidates and the factors discussed in the "Risk Factors" section of PTC's most recent Quarterly Report on Form 10-Q as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. 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 PTC does 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.
SOURCE PTC Therapeutics, Inc.