With a new CEO stepping in to steer the ship, some have wondered whether the move could lead to a slowdown at Vertex. The company's response? We’re still on track—and our pipeline is coming along, too.
Vertex’s Symdeko, a dual-drug cystic fibrosis (CF) med marketed as Symkevi abroad, nearly doubled its second-quarter sales over the previous year to $362 million—a 94.6% increase in the drug’s first year on the market.
Vertex has positioned Symdeko, which received an FDA nod in February 2018, as the successor for the drugmaker’s flagship CF med Orkambi, which saw a meager 1.6% increase in sales on the quarter to $316 million.
Part of Symdeko’s success has come from significant physician uptake tied to the drug’s broad label and positive phase 3 efficacy data over Orkambi showing an increase in FEV1, a measure of lung capacity, of more than 4%. Orkambi’s label, meanwhile, lists a benefit of more than 2.8%.
And the company is expecting big things from Symdeko—which combines compound tezacaftor with ivacaftor, a previously approved solo under the name Kalydeco—abroad, too.
“Given the strength of the clinical data we have, the demand is likely to be really, really strong (in overseas launches),” said Stuart Arbuckle, Vertex’s chief commercial officer, in a Wednesday earnings call to investors. “Those levels of efficacy are truly incredible.”
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With Symdeko performing well, Vertex is planning to hand the reins from CEO Jeffrey Leiden, who engineered the company’s push into the CF market, to Chief Medical Officer Reshma Kewalramani. But at least one analyst—Geoffrey Porges of SVB Leerink—said the move could forecast stagnant growth in the company’s near future.
In a note to investors last week, Porges expressed concerns that Leiden’s move away from the CEO role could lead to more top execs leaving the fold at a time when the drugmaker is pushing hard for an FDA approval for its CF triple-combo candidate, VX-445. At issue for Porges, despite Kewalramani’s long history leading clinical trials, is her lack of experience in a CEO role—a tough transition for a company looking to take its place in the big leagues.
“The experience of leading and executing large clinical trials is not necessarily evidence of preparedness for the complexity of leading a large public company,” Porges said.
In a few short months, Kewalramani will not only be tasked with heading the potential approval of VX-445, for which the company submitted a New Drug Application to the FDA last week, but also heading up the drugmaker’s push into at least seven new disease fields in its pipeline.
The drugmaker is currently working on candidates in alpha-1 antitrypsin, sickle cell disease and beta thalassemia, APOL1-mediate kidney disease, Duchenne muscular dystrophy and others.
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Vertex has also faced pushback abroad for Orkambi from England’s cost watchdog over its price, and it decided early this year not to pursue placement on the U.K.’s National Health Service for Symdeko despite widespread calls for a negotiated peace from CF advocates.
On the whole, Vertex generated $940 million on the quarter and raised its full-year revenue forecast to between $3.6 billion and $3.7 billion.