UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 21, 2019
Vertex Pharmaceuticals Incorporated
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
(617 ) 341-6100
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act: | ||||
Title of each class | Trading Symbol | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On October 21, 2019, the U.S. Food and Drug Administration approved TRIKAFTATM (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for treatment of cystic fibrosis in patients 12 years of age and older who have at least one F508del mutation.
We have established a wholesale acquisition cost for TRIKAFTA in the United States of $311,503 on an annual basis ($23,896 per 28-day pack).
With the early approval of TRIKAFTA, we are increasing our guidance for full-year 2019 CF net product revenues to $3.70 billion - $3.75 billion. Our previous guidance for full-year 2019 total CF net product revenues was $3.60 billion - $3.70 billion.
Special Note Regarding Forward-Looking Statements.
This report contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including the guidance we are providing regarding total CF net product revenues. While we believe the forward-looking statements contained in this report are accurate, these forward-looking statements represent our beliefs only as of the date of this report and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that expectations regarding our CF net product revenues may be incorrect (including because one or more of the assumptions underlying our expectations may not be realized) and other risks listed under Risk Factors in our annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through our website at www.vrtx.com. We disclaim any obligation to update the information contained in this report as new information becomes available.
SEC Information.
The information set forth in this Item 7.01 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
VERTEX PHARMACEUTICALS INCORPORATED | |
(Registrant) | |
Date: October 21, 2019 | /s/ Michael Parini |
Michael Parini Executive Vice President, Chief Legal and Administrative Officer | |