Release Details
PTC Therapeutics Reports First Quarter 2017 Financial Results and Provides Corporate Update
"We are thrilled to bring EMFLAZA to Duchenne muscular dystrophy patients in
First Quarter Financial Highlights:
- Translarna net product sales were
$26.4 million for the first quarter of 2017, representing 40% growth over$18.9 million reported in the first quarter of 2016. - Total revenues for the first quarter of 2017 were
$26.5 million compared to$18.9 million in the same period of 2016. The change in total revenue was a result of the expanded commercial launch of Translarna. - GAAP R&D expenses were
$27.4 million for the first quarter of 2017 compared to$31.4 million for the same period in 2016. Non-GAAP R&D expenses were$22.9 million for the first quarter of 2017, excluding$4.5 million in non-cash, stock-based compensation expense, compared to$26.4 million for the same period in 2016, excluding$4.3 million in non-cash, stock-based compensation expense and one-time restructuring costs of$0.7 million . The decrease in R&D expense for the first quarter of 2017 as compared to the prior year period was primarily due to the completion of our ACT CF study at the end of 2016 and the ongoing reduction of clinical trial expenses. - GAAP SG&A expenses were
$25.5 million for the first quarter of 2017 compared to$25.9 million for the same period in 2016. Non-GAAP SG&A expenses were$20.9 million for the first quarter of 2017, excluding$4.6 million in non-cash, stock-based compensation expense, compared to$20.2 million for the same period in 2016, excluding$4.6 million in non-cash, stock-based compensation expense and one-time restructuring costs of$1.2 million . SG&A expenses were relatively flat for the first quarter of 2017 as compared to the same period in 2016. - Net interest expense for the first quarter of 2017 was
$2.2 million compared to net interest expense of$2.0 million in the same period in 2016. The increase in net interest expense is primarily a result of reduced interest income from investments. - Net loss for the first quarter of 2017 was
$29.1 million compared to a net loss of$41.2 million for the same period in 2016. - Cash, cash equivalents, and marketable securities totaled approximately
$202.6 million atMarch 31, 2017 compared to approximately$231.7 million atDecember 31, 2016 . - Shares issued and outstanding as of
March 31, 2017 were 34.6 million, which includes 0.3 million shares of unvested restricted stock.
2017 Guidance:
- Translarna net sales for 2017 are now anticipated to be between
$115 and$130 million , an increase from prior guidance of$105 to$125 million . This guidance assumes the current exchange rates and the continued commercial expansion for Translarna in nmDMD outside of theU.S. Taking into account the time to achieve reimbursement and other launch-related factors, PTC anticipates EMFLAZA net sales for 2017 to be between$5 and$10 million . PTC also anticipates a potential$20 million milestone payment in 2017 related to the SMA program for total 2017 revenues between$120 and$160 million . - GAAP operating expenses for full year 2017 are anticipated to be between
$250 to$260 million . Excluding estimated non-cash, stock-based compensation expense of approximately$40 million , full year 2017 non-GAAP operating expenses are anticipated to be between$210 and$220 million . These operating expenses are expected to be primarily in support of the commercial availability of Translarna outside of theU.S. and in support of the pending commercial launch of EMFLAZA in theU.S. , as well as the continued research and clinical development of other product pipeline candidates. - PTC recently closed on a
$60 million senior secured term loan facility withMidCap Financial , of which$40 million was drawn at close. As a result of the$75 million in cash utilized in the EMFLAZA acquisition, partially offset by the$40 million draw-down of term-loan financing fromMidCap Financial , PTC now expects to end 2017 with cash and cash equivalents of approximately$100 million .
Key First Quarter and other Corporate Highlights:
- Commercial launch of EMFLAZA for the treatment of Duchenne muscular dystrophy. PTC is preparing for the commercial launch of EMFLAZA in the
U.S. , which is expected to begin in the coming weeks. PTC has established programs with the goal of ensuring that eligible patients will have access to EMFLAZA regardless of financial or insurance status. Over 900 patients, about 10% of the 9,000 eligible Duchenne patients in theU.S. , have already been prescribed EMFLAZA and submitted START forms. - Review of the Translarna NDA for nonsense mutation Duchenne muscular dystrophy by the
FDA in progress. TheFDA acknowledged PTC's filing over protest of the New Drug Application (NDA) for Translarna for the treatment of nmDMD and assigned the company a Prescription Drug User Fee Act (PDUFA) target date ofOctober 24, 2017 . - Two SMA clinical trials on track to advance into pivotal studies in 2017. The spinal muscular atrophy (SMA) program, a joint collaboration with Roche and the
SMA Foundation , is expected to advance into two pivotal studies in 2017. The SUNFISH study in Type 2/3 patients and the FIREFISH study in Type 1 patients are both enrolling the initial dose escalation part of the respective studies. Initiation of the pivotal second part of both studies is expected in the second half of 2017 and initiation of the first pivotal study will trigger a single$20 million milestone payment to PTC from Roche. Data from the first part of the studies is expected to be presented at scientific meetings later this year and early next year.
Non-GAAP Financial Measures:
In this press release, PTC's financial results and financial guidance are provided in accordance with accounting principles generally accepted in
Consolidated Statements of Operations (In thousands, except per share data) | ||||||||
Three Months Ended |
||||||||
2017 |
2016 |
|||||||
Revenues: |
||||||||
Net product revenue................................................................................. |
$ |
26,442 |
$ |
18,878 |
||||
Collaboration and grant revenue.............................................................. |
105 |
17 |
||||||
Total revenues.............................................................................................. |
26,547 |
18,895 |
||||||
Operating expenses: |
||||||||
Cost of product sales............................................................................... |
39 |
— |
||||||
Research and development (1)............................................................... |
27,363 |
31,399 |
||||||
Selling, general and administrative (2).................................................... |
25,500 |
25,938 |
||||||
Total operating expenses............................................................................. |
52,902 |
57,337 |
||||||
Loss from operations................................................................................... |
(26,355) |
(38,442) |
||||||
Interest expense, net................................................................................... |
(2,219) |
(1,956) |
||||||
Other expense, net...................................................................................... |
(318) |
(721) |
||||||
Loss before income tax expense................................................................. |
(28,892) |
(41,119) |
||||||
Income tax expense...................................................................................... |
(165) |
(114) |
||||||
Net loss attributable to common stockholders.......................................... |
$ |
(29,057) |
$ |
(41,233) |
||||
Weighted-average shares outstanding: |
||||||||
Basic and diluted (in shares).................................................................... |
34,305,948 |
33,919,169 |
||||||
Net loss per share—basic and diluted (in dollars per share)....................... |
$ |
(0.85) |
$ |
(1.22) |
||||
(1) Research and development expense reconciliation |
||||||||
GAAP research and development |
$ |
27,363 |
$ |
31,399 |
||||
Less: share-based compensation |
4,467 |
4,328 |
||||||
Less: one-time restructuring cost |
— |
716 |
||||||
Non-GAAP research and development expense |
$ |
22,896 |
$ |
26,355 |
||||
(2) Selling, general and administrative expense reconciliation |
||||||||
GAAP selling, general and administrative |
$ |
25,500 |
$ |
25,938 |
||||
Less: share-based compensation |
4,562 |
4,587 |
||||||
Less: one-time restructuring cost |
— |
1,187 |
||||||
Non-GAAP selling, general and administrative expense |
$ |
20,938 |
$ |
20,164 |
||||
Summary Consolidated Balance Sheets (In thousands, except per share data) | |||||||
|
|
||||||
Cash, cash equivalents and marketable securities............................................ |
$ |
202,577 |
$ |
231,666 |
|||
Total assets..................................................................................................... |
$ |
248,645 |
$ |
269,345 |
|||
Total debt............................................................................................................ |
$ |
99,895 |
$ |
98,216 |
|||
Total deferred revenue....................................................................................... |
2,194 |
1,587 |
|||||
Total liabilities................................................................................................. |
$ |
147,818 |
$ |
149,762 |
|||
Total stockholders' equity (34,316,836 and 34,169,410 common shares |
100,827 |
119,583 |
|||||
Total liabilities and stockholders' equity.................................................. |
$ |
248,645 |
$ |
269,345 |
Today's Conference Call and Webcast Reminder
Today's conference call will take place at
About
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
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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; timing of the pending commercial launch in the
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 preparations for a commercial launch of EMFLAZA in the
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.
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