CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Shares of Vertex Pharmaceuticals Inc. (VRTX) were up more than 5 percent in extended trading on Thursday, following strong fourth-quarter and full-year 2019 financial results and rosy outlook.
On a non-GAAP basis, the Company's net income for the fourth quarter of 2019 was $444 million or $1.70 per share on product revenue of $1.26 billion. Wall Street analysts were expecting earnings of $1.20 per share and revenue of $1.01 billion. The non-GAAP net income and product revenue in the fourth quarter of 2018 was $337 million or $1.30 per share and $868 million, respectively.
For full-year 2019, on a non-GAAP basis, Vertex Pharma's net income was $1.39 billion or $5.33 per share on product revenue of $4.00 billion compared to net income of $1.06 billion or $4.08 per share and product revenue of $3.04 billion. The Wall Street analysts' consensus earnings and revenue estimates were $4.77 per share and $3.76 billion, respectively.
Looking ahead to full-year 2020, the Company expects product revenue to range between $5.1 billion and $5.3 billion, well above analysts' consensus estimate of $4.87 billion.
The Company ended the year 2019 with cash, cash equivalents and marketable securities of $3.8 billion.
-- The triple combination regimen of elexacaftor, tezacaftor and ivacaftor for cystic fibrosis is under review by European Medicines Agency. This combo therapy was approved by the FDA, under the brand name Trikafta, in cystic fibrosis patients ages 12 years and older who have at least one F508del mutation, on October 21, 2019.
-- A phase III study evaluating Trikafta in children with cystic fibrosis ages 6 to 11 years who have two F508del mutations and in children who have one F508del mutation and one minimal function mutation is underway. If all goes well as planned, the company plans to submit a supplemental New Drug Application to the FDA in 2020 followed by additional submissions to other global regulatory agencies.
-- A phase II proof-of-concept study evaluating VX-814, the company's first oral small molecule corrector for the treatment of alpha-1 antitrypsin (AAT) deficiency is ongoing, with data expected this year.
-- A phase I study of VX-864, the company's second investigational small molecule corrector for the treatment of AAT deficiency is ongoing in healthy volunteers.
-- Two phase I/II clinical trials evaluating investigational CRISPR/Cas9 gene-editing therapy CTX001 - one in transfusion-dependent beta-thalassemia, dubbed CLIMB-Thal-111, and the other in severe sickle cell disease, known as CLIMB-SCD-121, are ongoing. Positive, interim data from the first two patients with severe hemoglobinopathies treated with CTX001 in the ongoing phase I/II clinical trials were reported last November. Additional data are expected this year.
-- A phase II proof-of-concept study of VX-147 for the treatment of APOL1-mediated kidney diseases is expected to be initiated this year.
Commenting on the results, Reshma Kewalramani, Executive Vice President and Chief Medical Officer of the Company said, 'Entering 2020, Vertex has never been stronger. Going forward, our financial strength will enable us to continue to significantly invest in internal R&D and external innovation, which will provide access to new technologies, programs and expertise that will lead to further growth in the years ahead.'
VRTX closed Thursday's trading at $230.31, down 0.90%. In after-hours, the stock was up over 5% to $243.11.
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