Full Press Release Details
SOUTH PLAINFIELD, N.J. , March 6, 2014 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported its financial results for the fourth quarter and full-year ended December 31, 2013.
"2013 was a landmark year for PTC with significant accomplishments achieved across the organization. Our private financing early in the year combined with a very successful IPO positioned us to execute on our strategy of leveraging our scientific platform to bring potentially disease-modifying therapies to patients suffering from rare disorders," stated Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "As we look ahead to 2014, we are excited to complete enrollment in our confirmatory Phase 3 ACT DMD clinical trial in nonsense mutation Duchenne muscular dystrophy, initiate our confirmatory Phase 3 clinical trial in nonsense mutation cystic fibrosis, and advance our SMA program, partnered with Roche and the SMA Foundation, into clinical development. We also plan to pursue additional indications for ataluren beyond nmDMD and nmCF and expect to initiate a proof-of-concept study for a third indication this year."
Recent Achievements
Fourth Quarter and Year-End Financial Results
2014 Financial Guidance
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, March 6, 2014 , at 4:30 p.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 3360375.
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 which form the basis for 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, our Phase 3 clinical trials for ataluren in nmDMD and nmCF, our collaboration in SMA with Roche and the SMA Foundation, our current and planned regulatory filings with the EMA, the timing of the re-examination of the CHMP opinion, our earlier stage programs, including our initiation of a potential proof-of-concept study, 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 final prospectus dated February 12, 2014 for our public offering completed in February 2014 , 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.
| PTC Therapeutics, Inc. | |||||||
| Statements of Operations | |||||||
| (In thousands, except share amounts) | |||||||
| Three Months Ended | Twelve Months Ended | ||||||
| December 31, | December 31, | ||||||
| 2013 | 2012 | 2013 | 2012 | ||||
| Revenues: | |||||||
| Collaboration revenue | $3,931 | $5,918 | $31,326 | $28,779 | |||
| Grant revenue | 480 | 722 | 3,370 | 5,167 | |||
| Total revenues | 4,411 | 6,640 | 34,696 | 33,946 | |||
| Operating expenses: | |||||||
| Research and development (1) | 15,020 | 9,450 | 54,875 | 46,139 | |||
| General and administrative (1) | 7,483 | 3,224 | 25,219 | 14,615 | |||
| Total operating expenses | 22,503 | 12,674 | 80,094 | 60,754 | |||
| Loss from operations | (18,092) | (6,034) | (45,398) | (26,808) | |||
| Interest (expense) income, net | 166 | (203) | (6,084) | (1,210) | |||
| Loss on extinguishment of debt | — | — | (130) | — | |||
| Other income (expense), net | 41 | (35) | 38 | 1,783 | |||
| Net loss | (17,885) | (6,272) | (51,574) | (26,235) | |||
| Deemed dividend | — | — | (18,249) | — | |||
| Gain on exchange of convertible preferred stock in | |||||||
| connection with recapitalization | — | — | 3,391 | 159,954 | |||
| Less beneficial conversion charge | — | — | — | (378) | |||
| Net (loss) income attributable to common stockholders | ($17,885) | ($6,272) | ($66,432) | $133,341 | |||
| Weighted-average shares outstanding (in shares): | |||||||
| Basic | 23,803,282 | 4,545 | 12,829,411 | 3,328 | |||
| Diluted | 23,803,282 | 4,545 | 12,829,411 | 17,205 | |||
| Net (loss) income per share applicable to common | |||||||
| stockholders - basic (in dollars per share) | ($0.75) | ($1,380.13) | ($5.18) | $219.76 | |||
| Net (loss) income per share applicable to common | |||||||
| stockholders - diluted (in dollars per share) | ($0.75) | ($1,380.13) | ($5.18) | $42.50 | |||
| (1) Non-cash share-based compensation expense | |||||||
| included in operating expenses are as follows: | |||||||
| Research and development | $662 | $150 | $2,040 | $804 | |||
| General and administrative | 2,623 | 322 | 6,387 | 1,484 | |||
| Total share-based compensation expense | $3,285 | $472 | $8,427 | $2,288 |
| PTC Therapeutics, Inc. | |||
| Summary Balance Sheet | |||
| (In thousands, except share amounts) | |||
| December 31, | December 31, | ||
| 2013 | 2012 | ||
| Cash, cash equivalents and marketable securities | $142,468 | $2,726 | |
| Total assets | $151,903 | $13,072 | |
| Total debt | 49 | 4,883 | |
| Total deferred revenue | 877 | 17,432 | |
| Total liabilities | $15,360 | $31,889 | |
| Total stockholders' equity (deficit) (23,803,282 and 4,526 common shares | |||
| issued and outstanding at December 31, 2013 and 2012, respectively) | 136,542 | (99,641) | |
| Total liabilities, convertible preferred stocks and stockholders' (deficit) equity | $151,903 | $13,072 |
SOURCE PTC Therapeutics, Inc.