"As we enter the second half of the year, we continue to make
significant progress toward achieving all of our key goals," commented
Research and Development Updates
Vertex today provided the following research and development updates:
KALYDECO® (ivacaftor)
Global Availability of KALYDECO (ivacaftor)
Additional Activities and Clinical Studies Aimed at Increasing the Number of People Eligible for Ivacaftor
Lumacaftor in Combination with Ivacaftor
Planned Regulatory Submissions for People 12 and Older with Two Copies of the F508del Mutation
Orphan Drug Designation
Phase 2 Study in People with One Copy of the F508del Mutation (heterozygous)
VX-661 in Combination with Ivacaftor
Ongoing 12-Week Study in People with Two Copies of the F508del Mutation
Second Quarter 2014 Non-GAAP Financial Results
The second quarter 2014 non-GAAP financial results exclude stock-based
compensation expense, transition and restructuring costs related to the
relocation of our corporate headquarters, a one-time cash payment
received related to a lease agreement, hepatitis C costs and revenue and
other adjustments. The second quarter 2013 non-GAAP financial results
exclude stock-based compensation expense, expenses related to
Total Non-GAAP Revenues: Total non-GAAP revenues for the second
quarter of 2014 were
Three Months Ended |
||||||||||||||
(in millions) | ||||||||||||||
GAAP revenues | HCV related revenues | Non-GAAP revenues | ||||||||||||
Product revenues | ||||||||||||||
KALYDECO revenues, net | $ | 113.1 | $ | — | $ | 113.1 | ||||||||
INCIVEK revenues, net | 9.3 | (9.3 | ) | — | ||||||||||
Total product revenues, net | $ | 122.4 | $ | (9.3 | ) | $ | 113.1 | |||||||
Royalty revenues | 13.0 | (5.7 | ) | 7.3 | ||||||||||
Collaborative revenues | 3.0 | (1.5 | ) | 1.5 | ||||||||||
Total revenues | $ | 138.4 | $ | (16.5 | ) | $ | 121.9 | |||||||
Non-GAAP Operating Expenses: Total non-GAAP operating expenses
for the second quarter of 2014 were
Non-GAAP Net Income (Loss) Attributable to Vertex: Vertex's
second quarter 2014 non-GAAP net loss was
Cash Position at
Cash Position: As of June 30, 2014, Vertex had
2014 Financial Guidance
This section contains forward-looking guidance about the financial
outlook for
Non-GAAP Financial Measures
In this press release, Vertex's financial results and financial guidance
are provided in accordance with accounting principles generally accepted
in
Second Quarter 2014 GAAP Financial Results
Total Revenues: Total revenues for the second quarter of 2014
were
Operating Costs and Expenses: Total operating costs and expenses
for the second quarter of 2014 were
Net Loss Attributable to Vertex: Vertex's second quarter 2014 net
loss was
|
||||||||||||||||||||||
Second Quarter Results | ||||||||||||||||||||||
Condensed Consolidated Statements of Operations Data | ||||||||||||||||||||||
(in thousands, except per share amounts) |
||||||||||||||||||||||
(unaudited) |
||||||||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||||||||
Revenues: | ||||||||||||||||||||||
Product revenues, net | $ | 122,319 | $ | 254,789 | $ | 225,780 | $ | 522,170 | ||||||||||||||
Royalty revenues | 13,015 | 49,120 | 23,748 | 92,693 | ||||||||||||||||||
Collaborative revenues | 3,087 | 6,841 | 7,344 | 24,255 | ||||||||||||||||||
Total revenues | 138,421 | 310,750 | 256,872 | 639,118 | ||||||||||||||||||
Costs and expenses: | ||||||||||||||||||||||
Cost of product revenues | 9,655 | 24,695 | 18,227 | 55,650 | ||||||||||||||||||
Royalty expenses | 7,645 | 13,236 | 14,549 | 25,024 | ||||||||||||||||||
Research and development expenses (R&D) | 224,780 | 222,455 | 463,743 | 440,550 | ||||||||||||||||||
Sales, general and administrative expenses (SG&A) | 77,446 | 106,521 | 151,658 | 199,400 | ||||||||||||||||||
Restructuring expenses | (270 | ) | 776 | 5,918 | 815 | |||||||||||||||||
Intangible asset impairment charge (Note 1) | — | — | — | 412,900 | ||||||||||||||||||
Total costs and expenses | 319,256 | 367,683 | 654,095 | 1,134,339 | ||||||||||||||||||
Loss from operations | (180,835 | ) | (56,933 | ) | (397,223 | ) | (495,221 | ) | ||||||||||||||
Interest expense, net | (15,585 | ) | (6,551 | ) | (31,302 | ) | (10,016 | ) | ||||||||||||||
Other income (expense), net (Note 2) | 37,731 | (27 | ) | 38,182 | (1,214 | ) | ||||||||||||||||
Loss before provision for (benefit from) income taxes | (158,689 | ) | (63,511 | ) | (390,343 | ) | (506,451 | ) | ||||||||||||||
Provision for (benefit from) income taxes (Note 1) | 693 | (1,799 | ) | 1,496 | (132,112 | ) | ||||||||||||||||
Net loss | (159,382 | ) | (61,712 | ) | (391,839 | ) | (374,339 | ) | ||||||||||||||
Net loss attributable to noncontrolling interest (Note 3) | — | 4,547 | — | 9,158 | ||||||||||||||||||
Net loss attributable to Vertex | $ | (159,382 | ) | $ | (57,165 | ) | $ | (391,839 | ) | $ | (365,181 | ) | ||||||||||
Net loss per share attributable to Vertex common shareholders: | ||||||||||||||||||||||
Basic | $ | (0.68 | ) | $ | (0.26 | ) | $ | (1.68 | ) | $ | (1.67 | ) | ||||||||||
Diluted | $ | (0.68 | ) | $ | (0.26 | ) | $ | (1.68 | ) | $ | (1.67 | ) | ||||||||||
Shares used in per share calculations: | ||||||||||||||||||||||
Basic | 233,808 | 222,053 | 233,353 | 218,795 | ||||||||||||||||||
Diluted | 233,808 | 222,053 | 233,353 | 218,795 | ||||||||||||||||||
Consolidated Revenues | |||||||||||||||||||||||||
(in millions) |
|||||||||||||||||||||||||
(unaudited) |
|||||||||||||||||||||||||
Three Months Ended | |||||||||||||||||||||||||
2014 |
2014 |
2013 |
2013 |
2013 |
|||||||||||||||||||||
Product revenues | |||||||||||||||||||||||||
KALYDECO revenues, net | $ | 113.1 | $ | 99.5 | $ | 109.5 | $ | 101.1 | $ | 99.0 | |||||||||||||||
INCIVEK revenues, net | 9.3 | 3.9 | 19.3 | 85.6 | 155.8 | ||||||||||||||||||||
Total product revenues, net | 122.4 | 103.5 | 128.8 | 186.7 | 254.8 | ||||||||||||||||||||
Royalty revenues | 13.0 | 10.7 | 36.9 | 27.0 | 49.1 | ||||||||||||||||||||
Collaborative revenues | 3.0 | 4.3 | 185.4 | 8.0 | 6.8 | ||||||||||||||||||||
Total revenues | $ | 138.4 | $ | 118.5 | $ | 351.2 | $ | 221.7 | $ | 310.8 | |||||||||||||||
Reconciliation of GAAP to |
|||||||||||||||||||||||||||||
(in thousands, except per share amounts) |
|||||||||||||||||||||||||||||
(unaudited) |
|||||||||||||||||||||||||||||
Three Months Ended |
Adjustments | ||||||||||||||||||||||||||||
GAAP |
Stock-based compensation expense (Note 4) |
Corporate headquarters relocation (Note 5) |
HCV related costs (Note 6) |
Other adjustments (Note 7) |
Non-GAAP | ||||||||||||||||||||||||
Income (loss) from operations | $ | (180,835 | ) | $ | 42,444 | $ | 12,761 | $ | (2,323 | ) | $ | 1,467 | $ | (126,486 | ) | ||||||||||||||
Other income (expense), net | 22,146 | — | (36,685 | ) | — | — | (14,539 | ) | |||||||||||||||||||||
Income (loss) before provision for (benefit from) incomes taxes | (158,689 | ) | 42,444 | (23,924 | ) | (2,323 | ) | 1,467 | (141,025 | ) | |||||||||||||||||||
Provision for (benefit from) income taxes | 693 | — | — | — | — | 693 | |||||||||||||||||||||||
Net income (loss) | $ | (159,382 | ) | $ | 42,444 | $ | (23,924 | ) | $ | (2,323 | ) | $ | 1,467 | $ | (141,718 | ) | |||||||||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 8) | $ | (0.68 | ) | $ | (0.61 | ) | |||||||||||||||||||||||
Three Months Ended |
Adjustments | |||||||||||||||||||||||||||
GAAP |
Stock-based compensation expense (Note 4) |
|
HCV related costs (Note 6) |
Other adjustments (Note 7) |
Non-GAAP | |||||||||||||||||||||||
Income (loss) from operations | $ | (56,933 | ) | $ | 41,263 | $ | 7,007 | $ | 5,083 | $ | 776 | $ | (2,804 | ) | ||||||||||||||
Other income (expense), net | (6,578 | ) | — | (183 | ) | — | 3,908 | (2,853 | ) | |||||||||||||||||||
Income (loss) before provision for (benefit from) incomes taxes | (63,511 | ) | 41,263 | 6,824 | 5,083 | 4,684 | (5,657 | ) | ||||||||||||||||||||
Provision for (benefit from) income taxes | (1,799 | ) | — | 2,357 | — | — | 558 | |||||||||||||||||||||
Net income (loss) | (61,712 | ) | 41,263 | 4,467 | 5,083 | 4,684 | (6,215 | ) | ||||||||||||||||||||
Net loss (income) attributable to noncontrolling interest ( |
4,547 | — | (4,547 | ) | — | — | — | |||||||||||||||||||||
Net income (loss) attributable to Vertex | $ | (57,165 | ) | $ | 41,263 | $ | (80 | ) | $ | 5,083 | $ | 4,684 | $ | (6,215 | ) | |||||||||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 8) | $ | (0.26 | ) | $ | (0.03 | ) | ||||||||||||||||||||||
Reconciliation of GAAP to |
|||||||||||
(in thousands) |
|||||||||||
(unaudited) |
|||||||||||
Three Months Ended |
|||||||||||
2014 | 2013 | ||||||||||
GAAP total costs and expenses | $ | 319,256 | $ | 367,683 | |||||||
Adjustments: | |||||||||||
Cost of product revenues and royalty expenses | (17,300 | ) | (37,931 | ) | |||||||
Stock-based compensation expense (Note 4) | (42,444 | ) | (41,263 | ) | |||||||
Corporate headquarters relocation (Note 5) | (12,761 | ) | — | ||||||||
HCV related costs (Note 6) | (7,889 | ) | — | ||||||||
|
— | (7,007 | ) | ||||||||
Other adjustments (Note 7) | (1,467 | ) | (776 | ) | |||||||
Non-GAAP operating costs and expenses | $ | 237,395 | $ | 280,706 | |||||||
GAAP research and development expenses | $ | 224,780 | $ | 222,455 | |||||||
Adjustments: | |||||||||||
Stock-based compensation expense (Note 4) | (27,253 | ) | (25,700 | ) | |||||||
Corporate headquarters relocation (Note 5) | (9,382 | ) | — | ||||||||
HCV related costs (Note 6) | (5,049 | ) | — | ||||||||
|
— | (5,566 | ) | ||||||||
Other adjustments (Note 7) | (3,584 | ) | — | ||||||||
Non-GAAP research and development expenses | $ | 179,512 | $ | 191,189 | |||||||
GAAP sales, general and administrative expenses | $ | 77,446 | $ | 106,521 | |||||||
Adjustments: | |||||||||||
Stock-based compensation expense (Note 4) | (15,191 | ) | (15,563 | ) | |||||||
Corporate headquarters relocation (Note 5) | (1,706 | ) | — | ||||||||
HCV related costs (Note 6) | (2,666 | ) | — | ||||||||
|
— | (1,441 | ) | ||||||||
Non-GAAP sales, general and administrative expenses | $ | 57,883 | $ | 89,517 | |||||||
Reconciliation of GAAP to Non-GAAP Financial Information-Six Month | ||||||||||||||||||||||||||||
(in thousands, except per share amounts) |
||||||||||||||||||||||||||||
(unaudited) |
||||||||||||||||||||||||||||
Six Months Ended |
Adjustments | |||||||||||||||||||||||||||
GAAP |
Stock-based compensation expense (Note 4) |
Corporate headquarters relocation (Note 5) |
HCV related costs (Note 6) |
Other adjustments (Note 7) |
Non-GAAP | |||||||||||||||||||||||
Income (loss) from operations | $ | (397,223 | ) | $ | 89,024 | $ | 32,370 | $ | 8,999 | $ | 5,123 | $ | (261,707 | ) | ||||||||||||||
Other income (expense), net | 6,880 | — | (36,685 | ) | — | — | (29,805 | ) | ||||||||||||||||||||
Income (loss) before provision for (benefit from) incomes taxes | (390,343 | ) | 89,024 | (4,315 | ) | 8,999 | 5,123 | (291,512 | ) | |||||||||||||||||||
Provision for (benefit from) income taxes | 1,496 | — | — | — | — | 1,496 | ||||||||||||||||||||||
Net income (loss) | $ | (391,839 | ) | $ | 89,024 | $ | (4,315 | ) | $ | 8,999 | $ | 5,123 | $ | (293,008 | ) | |||||||||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 8) | $ | (1.68 | ) |
|
||||||||||||||||||||||||
Six Months Ended |
Adjustments | |||||||||||||||||||||||||||
GAAP |
Stock-based compensation expense (Note 4) |
|
HCV related costs (Note 6) |
Other adjustments (Note 7) |
Non-GAAP | |||||||||||||||||||||||
Income (loss) from operations | $ | (495,221 | ) | $ | 72,416 | $ | 12,296 | $ | 417,983 | $ | 815 | $ | 8,289 | |||||||||||||||
Other income (expense), net | (11,230 | ) | — | (175 | ) | — | 3,908 | (7,497 | ) | |||||||||||||||||||
Income (loss) before provision for (benefit from) incomes taxes | (506,451 | ) | 72,416 | 12,121 | 417,983 | 4,723 | 792 | |||||||||||||||||||||
Provision for (benefit from) income taxes | (132,112 | ) | — | 5,783 | 127,586 | — | 1,257 | |||||||||||||||||||||
Net income (loss) | (374,339 | ) | 72,416 | 6,338 | 290,397 | 4,723 | (465 | ) | ||||||||||||||||||||
Net loss (income) attributable to noncontrolling interest ( |
9,158 | — | (9,158 | ) | — | — | — | |||||||||||||||||||||
Net income (loss) attributable to Vertex | $ | (365,181 | ) | $ | 72,416 | $ | (2,820 | ) | $ | 290,397 | $ | 4,723 | $ | (465 | ) | |||||||||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 8) | $ | (1.67 | ) |
|
||||||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Information-Six Month | |||||||||||
(in thousands) |
|||||||||||
(unaudited) |
|||||||||||
Six Months Ended |
|||||||||||
2014 | 2013 | ||||||||||
GAAP total costs and expenses | $ | 654,095 | $ | 1,134,339 | |||||||
Adjustments: | |||||||||||
Cost of product revenues and royalty expenses | (32,776 | ) | (80,674 | ) | |||||||
Stock-based compensation expense (Note 4) | (89,024 | ) | (72,416 | ) | |||||||
Corporate headquarters relocation (Note 5) | (32,370 | ) | — | ||||||||
HCV related costs (Note 6) | (23,441 | ) | — | ||||||||
|
— | (12,296 | ) | ||||||||
Other adjustments (Note 7) | (5,123 | ) | (413,715 | ) | |||||||
Non-GAAP operating costs and expenses | $ | 471,361 | $ | 555,238 | |||||||
GAAP research and development expenses | 463,743 | 440,550 | |||||||||
Adjustments: | |||||||||||
Stock-based compensation expense (Note 4) | (60,153 | ) | (44,973 | ) | |||||||
Corporate headquarters relocation (Note 5) | (21,583 | ) | — | ||||||||
HCV related costs (Note 6) | (14,046 | ) | — | ||||||||
|
— | (9,614 | ) | ||||||||
Other adjustments (Note 7) | (6,909 | ) | — | ||||||||
Non-GAAP research and development expenses | 361,052 | 385,963 | |||||||||
GAAP sales, general and administrative expenses | $ | 151,658 | $ | 199,400 | |||||||
Adjustments: | |||||||||||
Stock-based compensation expense (Note 4) | (28,871 | ) | (27,443 | ) | |||||||
Corporate headquarters relocation (Note 5) | $ | (3,906 | ) | — | |||||||
HCV related costs (Note 6) | (8,572 | ) | — | ||||||||
|
— | (2,682 | ) | ||||||||
Non-GAAP sales, general and administrative expenses | $ | 110,309 | $ | 169,275 | |||||||
Condensed Consolidated Balance Sheets Data | ||||||||||
(in thousands) |
||||||||||
(unaudited) |
||||||||||
|
|
|||||||||
Assets | ||||||||||
Cash, cash equivalents and marketable securities | $ | 1,219,161 | $ | 1,465,076 | ||||||
Accounts receivable, net | 81,842 | 85,517 | ||||||||
Inventories | 11,982 | 14,147 | ||||||||
Other current assets | 34,399 | 23,836 | ||||||||
Restricted cash | 129 | 130 | ||||||||
Property and equipment, net | 730,000 | 696,911 | ||||||||
Goodwill | 30,992 | 30,992 | ||||||||
Other non-current assets | 9,315 | 2,432 | ||||||||
Total assets | $ | 2,117,820 | $ | 2,319,041 | ||||||
Liabilities and Shareholders' Equity | ||||||||||
Other liabilities | $ | 388,020 | $ | 422,377 | ||||||
Accrued restructuring expense | 18,984 | 28,353 | ||||||||
Deferred revenues | 65,279 | 70,969 | ||||||||
Construction financing lease obligation | 473,268 | 440,937 | ||||||||
Shareholders' equity | 1,172,269 | 1,356,405 | ||||||||
Total liabilities and shareholders' equity | $ | 2,117,820 | $ | 2,319,041 | ||||||
Common shares outstanding | 237,331 | 233,789 | ||||||||
Note 1: The company determined that the value of VX-222 had
become impaired and that the fair value of VX-222 was zero as of
Note 2: The company recorded the effect of a one-time cash payment received related to a lease agreement in Other income (expense), net during the second quarter of 2014.
Note 3: The company consolidated the financial statements of its
collaborator
Note 4: Stock-based compensation expense in the three and six
months ended
Note 5: In the three and six months ended
Note 6: In the three and six months ended
Note 7: In the three and six months ended
Note 8: Shares used in non-GAAP net income (loss) per diluted
share attributable to Vertex common shareholders were 233,808,000 and
222,053,000 for the three months ended
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO (ivacaftor)
Ivacaftor (150 mg tablets) is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.
In
Ivacaftor is not effective in patients with CF with 2 copies of the F508del mutation (F508del/F508del) in the CFTR gene. The safety and efficacy of ivacaftor in children with CF younger than 6 years of age have not been established.
Elevated liver enzymes (transaminases; ALT and AST) have been reported in patients receiving ivacaftor. It is recommended that ALT and AST be assessed prior to initiating ivacaftor, every 3 months during the first year of treatment, and annually thereafter. Patients who develop increased transaminase levels should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal. Following resolution of transaminase elevations, consider the benefits and risks of resuming ivacaftor dosing.
Use of ivacaftor with medicines that are strong CYP3A inducers, such as the antibiotics rifampin and rifabutin; seizure medications (phenobarbital, carbamazepine, or phenytoin); and the herbal supplement St. John's Wort, substantially decreases exposure of ivacaftor and may diminish effectiveness. Therefore, co-administration is not recommended.
The dose of ivacaftor must be adjusted when used concomitantly with strong and moderate CYP3A inhibitors or when used in patients with moderate or severe hepatic disease.
Ivacaftor can cause serious adverse reactions including abdominal pain and high liver enzymes in the blood. The most common side effects associated with ivacaftor include headache; upper respiratory tract infection (the common cold), including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; and dizziness. These are not all the possible side effects of ivacaftor. A list of the adverse reactions can be found in the product labeling for each country where ivacaftor is approved. Patients should tell their healthcare providers about any side effect that bothers them or does not go away.
Please see KALYDECO U.S. Prescribing Information, EU Summary of Product Characteristics, Canadian Product Monograph, Australian Consumer Medicine Information and Product Information, Swiss Prescribing Information and Patient Information, and the New Zealand Datasheet and Consumer Medicine Information.
Indication and Important Safety Information for INCIVEK (telaprevir)
INCIVEK® (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.
Important Safety Information
INCIVEK® (telaprevir) should always be used in combination with peginterferon alfa and ribavirin. INCIVEK combination treatment may cause serious side effects including skin rash and serious skin reactions, anemia (low red blood cell count) that can be severe, and birth defects or death of an unborn baby.
Skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become serious, require treatment in a hospital, and may lead to death. Patients should call their healthcare provider right away if they develop any skin changes or itching during treatment with INCIVEK. Their healthcare provider will decide if they need treatment or if they need to stop INCIVEK or any of their other medicines. Patients should not stop taking INCIVEK combination treatment without talking with their healthcare provider first.
Patients' healthcare providers will do blood tests regularly to check for anemia. If anemia is severe, the healthcare providers may tell them to stop taking INCIVEK.
INCIVEK combined with peginterferon alfa and ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Females who can become pregnant and females whose male partner takes these medicines must have a negative pregnancy test before starting treatment, every month during treatment, and for 6 months after treatment ends. Patients must use two forms of effective birth control during treatment and for 6 months after all treatment has ended. These two forms of birth control should not contain hormones, as these may not work during treatment with INCIVEK.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life-threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of INCIVEK combination treatment include itching, nausea, diarrhea, vomiting, anal or rectal problems (including hemorrhoids, discomfort, burning or itching around or near the anus), taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare provider about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information including Boxed Warning, and the Medication Guide for INCIVEK available at www.INCIVEK.com.
About Vertex
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including, without
limitation, Dr. Leiden's statements in the second paragraph of the press
release, the information provided in the section captioned "2014
Financial Guidance," and the information provided regarding (i) the
European Commission's review of the CHMP's positive opinion recommending
the approval of KALYDECO for people with CF who have one of eight
mutations; (ii) Vertex's sNDA in the U.S. and an MAA variation in
Conference Call and Webcast
The company will host a conference call and webcast today at
(VRTX-GEN)
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