Vertex Pharmaceuticals, Inc. (NASDAQ: VRTX) stock rose over 2% in the pre-market session on April 27th, 2018.
Going forward, the group forecasts to move one or more potential medicines from their internal research programs into clinical development in other disease in 2018. They made a positive start in 2018 while the first quarter 2018 financials was driven by the SYMDEKO launch in the U.S.
Revenues first, total CF product revenues surged 33% yoy to $638 million in the first quarter of 2018 from the $481 million during the first quarter 2017.
Their total product revenues continued to grow during each quarter with the number of patients treating with their approved medicines. The group forecasts over 34,000 patients which are eligible for their medicines of which about half are being treated. The number of patients continue to grow throughout 2018, thus driving revenue growth.
The group reported the initiation of two Phase 3 studies of VX-659, tezacaftor and ivacaftor, during the quarter as an investigational triple combination regimen for people with CF. The first study is evaluating the VX-659 triple-combination regimen as compared to the placebo in over 360 patients ages 12 and older who have a minimal function mutation.
The SYMDEKO launch also started positive in the U.S. while forecasts an approval in the EU in the second half of this year. The number of people eligible for one of their approved CF medicines has grown to 34,000 worldwide and about half of these patients are currently on treatment. With the launch of SYMDEKO the group is positioned to witness an ongoing solid revenue and earnings growth in 2018.
The group also started Phase 3 development for their second next-generation corrector, VX-445, as part of a triple combination regimen in the same groups of patients that they are evaluating with VX-659. They are reporting the initial Phase 2 data for VX-445 in triple combination in F508del homozygous patients. The efficacy observed was impressive and the safety profile of VX-445 was similar to that observed in earlier reported parts of this study. This Phase 2 study evaluated VX-445 or placebo in combination with tezacaftor and ivacaftor for four weeks after a four-week run-in of tezacaftor in combination with ivacaftor. FDA has requested a further dose ranging for VX-561, including potential evaluations of monotherapy before allowing evaluation of VX-561 in late-stage development.