$VRTX (Vertex Pharmaceuticals Incorporated)

$VRTX {{ '2015-07-29T20:52:53+0000' | timeago}} • Announcement

$VRTX 2Q15 PR: Vertex now expects 2015 KALYDECO net revenues of $575-590MM vs. prior range of $560-580MM. The company reiterated its guidance for combined non-GAAP R&D and SG&A expenses in 2015 of $1.05-1.10Bil. Expected combined non-GAAP R&D and SG&A expenses exclude stock-based compensation expense and certain other expenses recorded in 2015.

$VRTX {{ '2017-09-06T14:56:39+0000' | timeago}} • Announcement

$VRTX has announced the appointment of Tom Graney as SVP and CFO with effect from Sept 13, 2017.  He will report to EVP and COO Ian Smith.  Graney will be responsible for the development and execution of the financial strategies and operations of Vertex's business plans. He was the CFO and SVP of Finance and Corporate Strategy at $IRWD.

$VRTX {{ '2017-08-24T16:02:41+0000' | timeago}} • Announcement

Biotechnology firm $VRTX said the FDA and the European Medicines Agency have accepted its application for use of the tezacaftor/ivacaftor treatment in patients suffering from certain types of cystic fibrosis. Earlier, two phase-3 studies on the effectiveness of the drug combination had returned positive results.

$VRTX {{ '2017-08-01T19:57:27+0000' | timeago}} • Announcement

FDA approved $VRTX's Kalydeco for more than 600 people ages 2 and older with cystic fibrosis (CF) who have certain residual function mutations. After this, $VRTX lifted 2017 Kalydeco revenue guidance to $770-800MM from $740-770MM, and total CF product revenue outlook to $1.87-2.1Bil from $1.84-2.07Bil. This includes Orkambi guidance of $1.1-1.3Bil.

$VRTX {{ '2017-08-01T19:52:18+0000' | timeago}} • Announcement

$VRTX got FDA nod for cystic fibrosis (CF) drug Kalydeco for use in more than 600 people ages 2 and older with CF who have certain residual function mutations. This was based on phase 3 clinical data for Kalydeco in these mutations and follows the FDA's approval of the drug in May 2017 for 23 other residual function mutations.

$VRTX {{ '2017-07-26T20:38:11+0000' | timeago}} • Announcement

$VRTX also reviewed its recent progress toward treating all people with cystic fibrosis, including the completion of an asset purchase agreement with Concert Pharmaceuticals for worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis.

$VRTX {{ '2017-07-26T20:36:21+0000' | timeago}} • Announcement

$VRTX lifted 2017 non-GAAP combined research & development and selling, general & administrative expenses outlook to $1.33-1.36Bil from $1.25-1.30Bil, and GAAP combined R&D and SG&A expenses estimate to $1.79-1.92 from $1.55-1.70. The updated forecast reflects the progression of the company's cystic fibrosis portfolio.

$VRTX {{ '2017-07-26T20:33:48+0000' | timeago}} • Announcement

$VRTX expects 2017 total cystic fibrosis product revenue of $1.84-2.07Bil, comprised of Orkambi and Kalydeco product revenues. $VRTX still expects 2017 product revenue for Orkambi of $1.1-1.3Bil and for Kalydeco of $740-770MM.

$VRTX {{ '2017-07-26T20:30:18+0000' | timeago}} • Announcement

$VRTX's net product revenues from cystic fibrosis therapy Orkambi for 2Q17 increased to $324.4MM from $245.5MM last year. This was primarily driven by the continued uptake in the medicine globally and additional uptake in people with cystic fibrosis ages 6 to 11 in the U.S., where approval was received in September 2016.

$VRTX {{ '2017-07-26T20:26:38+0000' | timeago}} • Announcement

$VRTX reported net income for 2Q17 of $31.17MM or $0.07 per share compared to a loss of $64.53MM or $0.26 per share last year. This swing in results was driven by higher revenue as well as a decline in interest expenses. Revenue grew to $544.14MM from $431.61MM. Non-GAAP EPS increased to $0.39 from $0.24.

$VRTX {{ '2017-07-25T21:51:58+0000' | timeago}} • Announcement

$VRTX and $CNCE completed an asset purchase agreement, under which $VRTX gained worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis. $CNCE received $160MM in cash upon closing and is eligible to receive up to $90MM in additional milestones.

$VRTX {{ '2017-07-13T12:31:35+0000' | timeago}} • Announcement

$VRTX announced that the Italian Medicines Agency has agreed to reimburse ORKAMBI (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older who have two copies of the F508del mutation. Effective immediately, hundreds of eligible patients in Italy will have access to this medicine.

$VRTX {{ '2017-06-09T09:55:40+0000' | timeago}} • Announcement

$VRTX shareholders have elected Alan M Garber as an independent member of its board of directors. Garber is provost of Harvard University, the Mallinckrodt Professor of Health Care Policy at Harvard Medical School, a Professor of Economics in the Faculty of Arts and Sciences and a Professor of Public Policy in the Harvard Kennedy School of Govt.

$VRTX {{ '2017-05-18T12:30:41+0000' | timeago}} • Announcement

$VRTX said the U.S. Food and Drug Administration has approved Kalydeco (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator gene. $VRTX lifted outlook for 2017 product revenue of Kalydeco to $740-770MM from $710-730MM.

$VRTX {{ '2017-04-27T21:59:58+0000' | timeago}} • Webcast

In March 2017, $VRTX agreed to acquire CTP-656 (a therapy for the treatment of cystic fibrosis) from Concert Pharmaceuticals in a $160MM deal. The company is in the review period now and it has withdrawn and refiled pre-merger notification with the U.S. regulatory authorities.

$VRTX {{ '2017-04-27T21:35:40+0000' | timeago}} • Webcast

For 2017, $VRTX said that there is an uncertainty, mainly related to the timing of reimbursements in Europe. In France, there is an uncertainty because of the election. However, France is the largest contributor outside the U.S. for the company's 2017 revenues.

$VRTX {{ '2017-04-27T21:16:31+0000' | timeago}} • Webcast

$VRTX said that it is evaluating four next-generation correctors (VX-152, VX-440, VX-659 and VX-445), which will help in treating cystic fibrosis. The company expects to have data from the studies for the first three in 1H17 and from the fourth one in early 2018.

$VRTX {{ '2017-04-27T20:35:56+0000' | timeago}} • Announcement

$VRTX reiterated its FY17 guidance for ORKAMBI revenues and increased the guidance for KALYDECO. The company expects ORKAMBI FY17 total product revenues to be about $1.1-1.3Bil and increased FY17 product revenue guidance for KALYDECO to $710-730MM, from $690-710MM.

$VRTX {{ '2017-04-27T20:32:19+0000' | timeago}} • Announcement

Pharma company $VRTX reported 1Q17 net income of $247.8MM, or $0.99 per share, compared to net loss of $41.6MM, or $0.17 per share during 1Q16. On non-GAAP basis, $VRTX earned $0.41 per share. Revenue increased 79.5% to $714.7MM, helped by increased net product revenues from ORKAMBI.

$VRTX {{ '2017-03-29T11:23:47+0000' | timeago}} • Announcement

$VRTX posted that Tezacaftor/Ivacaftor combination treatment met primary endpoints in two phase 3 studies, regarding the treatment of people with cystic fibrosis. Vertex plans to submit a new drug application to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 3Q17.

$SNH {{ '2017-03-27T14:26:05+0000' | timeago}} • Announcement

The property included in the new JV with a sovereign institutional investor was acquired by $SNH in May 2014 for $1.125Bil. The two buildings are 95% leased to $VRTX through 2028. SNH expects to use cash proceeds from this transaction to repay a portion of the amounts outstanding under its revolving credit facility.

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