Item 7.01. Regulation FD Disclosure.
On Wednesday, January 15, 2020 at 8:30 am PT at the 38th Annual J.P. Morgan
Healthcare Conference (the "Conference"), PTC Therapeutics, Inc. (the "Company")
presented pursuant to advance notice its 2020 strategic priorities, preliminary
2019 financial results, and 2020 financial guidance. The Company's presentation
has been made available on the Events and Presentations page under the Investors
section of the Company's website. A copy of the slide deck, which the Company
presented to investors at the Conference, is attached as Exhibit 99.1.
The information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise
subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933, as amended, or
the Exchange Act, except as expressly set forth by specific reference in such a
filing.
Item 8.01 Other Events
At the Conference, the Company announced certain preliminary (unaudited)
financial information for its fiscal year ending December 31, 2019, including
that the Company expects to report (i) total unaudited revenue of approximately
$306 million, including net product revenue for the Duchenne muscular dystrophy
franchise of approximately $291 million and a $15 million milestone payment from
F. Hoffmann La Roche Ltd and Hoffmann La Roche Inc. for the risdiplam New Drug
Application ("NDA") acceptance; (ii) net product revenue for Translarna™ of
approximately $190 million, (iii) net product revenue for Emflaza® of
approximately $101 million and (iv) ending cash and cash equivalents of
approximately $686 million. Final results are subject to completion of the
Company's year-end audit and are subject to revision.
The Company also announced certain corporate updates, including that (i) the
Company submitted a Marketing Authorization Application for the potential
approval of a gene therapy treatment, PTC-AADC, for AADC deficiency with the
European Medicines Agency and the Company expects the Committee for Medicinal
Products for Human Use opinion in the second half of 2020, (ii) in a recent
interaction with the U.S. Food and Drug Administration (the "FDA") there was a
request for additional information concerning the use of the commercial delivery
system for PTC-AADC in young patients and the Company anticipates the submission
of a Biologics License Application to the FDA in the second quarter of 2020,
(iii) the Prescription Drug User Fee Act date for a decision by the FDA on the
risdiplam NDA is May 24, 2020 and (iv) in 2020, the Company plans to initiate
three clinical trials in its newly acquired redox platform including potential
registrational trials in mitochondrial epilepsy and Friedreich ataxia with
PTC743 and a Phase 1 trial with PTC857 targeting GBA Parkinson's disease.
Forward Looking Statements: All statements, other than those of historical fact,
contained in this Current Report on Form 8-K, are forward-looking statements,
including preliminary (unaudited) financial information for fiscal year 2019,
expectations with respect to future financial results and statements regarding:
expectations with respect to the Company's gene therapy platform, including any
potential regulatory submissions and manufacturing capabilities; and advancement
of the Company's joint collaboration program in spinal muscular atrophy ("SMA"),
including any potential regulatory submissions, commercialization or royalty or
milestone payments. The Company'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: the preliminary nature of the Company's 2019
financial information, which is subject to completion of the Company's year-end
audit; expectations with respect to the Company's gene therapy platform,
including any potential regulatory submissions and potential approvals,
manufacturing capabilities and the potential financial impact and benefits of
its leased biologics facility and the potential achievement of development,
regulatory and sales milestones and contingent payments that the Company may be
obligated to make; the enrollment, conduct, and results of studies under the SMA
collaboration and events during, or as a result of, the studies that could delay
or prevent further development under the program, including any potential
regulatory submissions and potential commercialization with regards to
risdiplam; and the factors discussed in the "Risk Factors" section of the
Company's Annual Report on Form 10-K for the year ended December 31, 2018,
Quarterly Reports on Form 10-Q for the periods ended March 31, 2019, June 30,
2019 and September 30, 2019 as well as any updates to these risk factors filed
from time to time in the Company's other filings with the Securities and
Exchange Commission. You are urged to carefully consider all such factors. The
forward-looking statements contained herein and the exhibit hereto represent the
Company's views only as of the date of this Current Report on Form 8-K and the
Company 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 Current Report on Form 8-K except as required by law. All
website addresses given in this Current Report on Form 8-K or incorporated
herein by reference are for information only and are not intended to be an
active link or to incorporate any website information into this Report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
Corporate Presentation - 38th Annual J.P. Morgan Healthcare
99.1 Conference
The cover page from this Current Report on Form 8-K, formatted in
104 Inline XBRL
© Edgar Online, source Glimpses