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Share Name | Share Symbol | Market | Type |
---|---|---|---|
PTC Therapeutics Inc | NASDAQ:PTCT | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
3.21 | 12.59% | 28.70 | 27.50 | 29.00 | 29.27 | 25.67 | 27.00 | 1,645,869 | 00:44:39 |
SOUTH PLAINFIELD, N.J., Aug. 8, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the second quarter ending June 30, 2017.
"Since our founding nearly 20 years ago, it has been our mission to provide treatments to patients living with rare diseases who have limited treatment options," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "I am proud to have introduced Translarna, the first therapy for nonsense mutation Duchenne muscular dystrophy patients and we remain dedicated to working with patients and their families to bring Translarna to the U.S. We are also pleased with the successful early launch of EMFLAZA. Consistent with our mission, we are working to ensure broad access to EMFLAZA to all eligible Duchenne patients regardless of financial or insurance status."
Second Quarter Financial Highlights:
2017 Guidance:
Key Second Quarter and Other Corporate Highlights:
Non-GAAP Financial Measures:
In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial measures exclude stock-based compensation expense and one-time restructuring expenses relating to the reorganization of operations intended to improve efficiency and better align costs and employment structure with PTC's strategic plans. These non-GAAP financial measures are provided as a complement to results reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management's opinion, these non-GAAP financial measures are useful to investors and other users of PTC's financial statements by providing greater transparency into the operating performance at PTC and the company's future outlook. Quantitative reconciliations of GAAP financial measures are included in the tables below.
PTC Therapeutics, Inc Consolidated Statements of Operations (In thousands, except per share data) Unaudited
| |||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||
2017 |
2016 |
2017 |
2016 |
||||||||||
Revenues: |
|||||||||||||
Net product revenue |
$ |
47,891 |
$ |
15,437 |
$ |
74,334 |
$ |
34,314 |
|||||
Collaboration and grant revenue |
71 |
196 |
176 |
214 |
|||||||||
Total revenues |
47,962 |
15,633 |
74,510 |
34,528 |
|||||||||
Operating expenses: |
|||||||||||||
Cost of product sales |
758 |
— |
797 |
— |
|||||||||
Research and development (1) |
30,835 |
28,827 |
58,198 |
60,226 |
|||||||||
Selling, general and administrative (2) |
28,866 |
23,366 |
54,365 |
49,304 |
|||||||||
Total operating expenses |
60,459 |
52,193 |
113,360 |
109,530 |
|||||||||
Loss from operations |
(12,497) |
(36,560) |
(38,850) |
(75,002) |
|||||||||
Interest expense, net |
(3,008) |
(2,060) |
(5,227) |
(4,016) |
|||||||||
Other expense, net |
(1,820) |
(387) |
(2,139) |
(1,107) |
|||||||||
Loss before income tax expense |
(17,325) |
(39,007) |
(46,216) |
(80,125) |
|||||||||
Income tax (expense) benefit |
(150) |
93 |
(316) |
(22) |
|||||||||
Net loss attributable to common stockholders |
$ |
(17,475) |
$ |
(38,914) |
$ |
(46,532) |
$ |
(80,147) |
|||||
Weighted-average shares outstanding: |
|||||||||||||
Basic and diluted (in shares) |
39,621,738 |
34,000,333 |
36,978,528 |
33,959,751 |
|||||||||
Net loss per share—basic and diluted (in dollars |
$ |
(0.44) |
$ |
(1.14) |
$ |
(1.26) |
$ |
(2.36) |
|||||
(1) Research and development reconciliation |
|||||||||||||
GAAP research and development |
$ |
30,835 |
$ |
28,827 |
$ |
58,198 |
$ |
60,226 |
|||||
Less: share-based compensation expense |
3,895 |
4,087 |
8,362 |
8,415 |
|||||||||
Less: one-time restructuring cost |
— |
118 |
— |
834 |
|||||||||
Non-GAAP research and development |
$ |
26,940 |
$ |
24,622 |
$ |
49,836 |
$ |
50,977 |
|||||
(2) Selling, general and administrative |
|||||||||||||
GAAP selling, general and administrative |
$ |
28,866 |
$ |
23,366 |
$ |
54,365 |
$ |
49,304 |
|||||
Less: share-based compensation expense |
3,990 |
4,649 |
8,552 |
9,236 |
|||||||||
Less: one-time restructuring cost |
— |
430 |
— |
1,617 |
|||||||||
Non-GAAP selling, general and administrative |
$ |
24,876 |
$ |
18,287 |
$ |
45,813 |
$ |
38,451 |
PTC Therapeutics, Inc Summary Consolidated Balance Sheets (In thousands, except per share data) Unaudited
| |||||||
June 30, |
December |
||||||
Cash, cash equivalents and marketable securities |
$ |
181,069 |
$ |
231,666 |
|||
Total assets |
$ |
383,078 |
$ |
269,345 |
|||
Total debt |
$ |
141,242 |
$ |
98,216 |
|||
Total deferred revenue |
6,430 |
1,587 |
|||||
Total liabilities |
$ |
213,347 |
$ |
149,762 |
|||
Total stockholders' equity (41,304,008 and 34,169,410 common |
169,731 |
119,583 |
|||||
Total liabilities and stockholders' equity |
$ |
383,078 |
$ |
269,345 |
Upcoming Events:
PTC management will present a company update at the upcoming Citi 12th Annual Biotech Conference on Thursday, September 7th. The presentation will be webcast live on the Events and Presentations page under the Investor Relations section of PTC Therapeutics website at www.ptcbio.com and will be archived for 2 weeks following the presentation. It is recommended that users connect to PTC's website several minutes prior to the start of the webcast to ensure a timely connection. PTC's current Investor Presentation is available at the same website location.
Today's Conference Call and Webcast Reminder:
Today's conference call will take place at 4:30 PM 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 58898313. 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
PTC is a global biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines using our expertise in RNA biology. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders and oncology. PTC has discovered all of its compounds currently under development using its proprietary technologies. Since its founding nearly 20 years ago, PTC's mission has focused on developing treatments to fundamentally change the lives of patients living with rare genetic disorders. The company was founded in 1998 and is headquartered in South Plainfield, New Jersey. For more information on the company, please visit our website www.ptcbio.com.
For More Information:
Investors:
Emily Hill
+ 1 (908) 912-9327
ehill@ptcbio.com
Media:
Jane Baj
+1 (908) 912-9167
jbaj@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 are forward-looking statements, including the information provided under the heading "2017 Guidance" and statements regarding: the future expectations, plans and prospects for PTC; the size of the DMD patient population eligible for EMFLAZA treatment in the U.S.; the PDUFA date and FDA advisory committee meeting date for the Translarna NDA; advancement of PTC's joint collaboration program in SMA, including whether and when Sunfish or Firefish may transition into the pivotal part of the applicable study and whether and when a milestone payment to PTC from Roche may be triggered; PTC's strategy, future operations, future financial position, future revenues or projected costs; and the objectives of management. Other forward-looking statements may be identified by the words "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "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: PTC's ability to realize the anticipated benefits of the acquisition of EMFLAZA, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition of EMFLAZA, as well as other business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the outcome of pricing, coverage and reimbursement negotiations with third party payors for EMFLAZA and Translarna; whether, and to what extent, third party payors impose additional requirements before approving EMFLAZA prescription reimbursement; PTC's ability to resolve the matters set forth in the Refuse to File letter it received from the FDA in connection with its NDA for Translarna for the treatment of nmDMD, including whether PTC's filing of the NDA over protest with the FDA will result in a timely or successful review of the NDA, and whether PTC will be required to perform additional clinical and non-clinical trials or analyses at significant cost, which, if successful, could potentially support the approval of the NDA filed over protest or a new NDA submission; the recommendation the advisory committee provides to the FDA for Translarna for the treatment of nmDMD; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in the European Economic Area (EEA), including whether the European Medicines Agency (EMA) determines in future annual renewal cycles that the benefit-risk balance of Translarna authorization supports renewal of such authorization; PTC's ability to enroll, fund, complete and timely submit to the EMA the results of Study 041, a randomized, 18-month, placebo-controlled clinical trial of Translarna for the treatment of nmDMD followed by an 18-month open label extension, which is a specific obligation to continued marketing authorization in the EEA; the eligible patient base and commercial potential of Translarna, EMFLAZA and PTC's other product candidates; the enrollment and conduct of studies under the SMA collaboration and events during, or as a result of, the studies that could delay or prevent further development of under the program; PTC's scientific approach and general development progress; PTC's ability to satisfy its obligations under the terms of the senior secured term loan facility with MidCap Financial; the sufficiency of PTC's cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures; 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.
As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including Translarna or EMFLAZA.
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 press release except as required by law.
View original content:http://www.prnewswire.com/news-releases/ptc-therapeutics-reports-second-quarter-2017-financial-results-and-provides-corporate-update-300501432.html
SOURCE PTC Therapeutics, Inc.
Copyright 2017 PR Newswire
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