Vertex Reports Full-Year and Fourth Quarter 2015 Financial Results

-Full-year 2015 total non-GAAP revenues of $1.01 billion, including net product revenues of $351 million for ORKAMBI® (lumacaftor/ivacaftor) and $632 million for KALYDECO® (ivacaftor) in cystic fibrosis-

-Vertex reiterates 2016 financial guidance for KALYDECO net product revenues of $670 to $690 million and for non-GAAP operating expenses of $1.18 to $1.23 billion-

-Phase 3 study of ORKAMBI in children ages 6 to 11 meets primary endpoint and supports planned supplemental New Drug Application in the second quarter of 2016; Approximately 2,400 children ages 6 to 11 would be eligible for treatment with ORKAMBI in the U.S.-

BOSTON -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the quarter ended December 31, 2015. Vertex also reiterated its financial guidance for total 2016 KALYDECO® (ivacaftor) net revenues and non-GAAP operating expenses. Key financial results include:

 
Three Months Ended December 31,
 
 
 
Twelve Months Ended December 31,
 
 
 
2015
 
2014
 
% Change
 
2015
 
2014
 
% Change
 
(in millions, except per share and percentage data)
ORKAMBI product revenues, net
$
220

 
$

 
N/A

 
$
351

 
$

 
N/A

KALYDECO product revenues, net
$
181

 
$
124

 
45
 %
 
$
632

 
$
464

 
36
 %
GAAP net loss
$
(76
)
 
$
(177
)
 
(57
)%
 
$
(558
)
 
$
(739
)
 
(24
)%
GAAP net loss per share
$
(0.31
)
 
$
(0.74
)
 
(58
)%
 
$
(2.31
)
 
$
(3.14
)
 
(26
)%
Non-GAAP net income (loss)
$
43

 
$
(132
)
 
N/A

 
$
(268
)
 
$
(511
)
 
(48
)%
Non-GAAP net income (loss) per share
$
0.17

 
$
(0.55
)
 
N/A

 
$
(1.11
)
 
$
(2.17
)
 
(49
)%

"Entering 2016, Vertex is in a strong financial position to support continued investment in our business to create future medicines for serious diseases and value for our shareholders," said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex. "We look forward to multiple important milestones over the coming year that will mark continued progress toward our goal of discovering and developing potential new medicines for all people with CF."


On January 10, 2016, Vertex provided a comprehensive update on its development programs in cystic fibrosis (CF) and other serious diseases. The company today provided the following updates and highlighted upcoming milestones:


1

The following information was filed by Vertex Pharmaceuticals Inc Ma (VRTX) on Wednesday, January 27, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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