Yahoo Finance 5 Things You'll Want to Know From Vertex Pharmaceuticals' Q1 Conference Call
You've probably heard by now that Vertex Pharmaceuticals (NASDAQ: VRTX) once again hit the ball out of the park with its 2018 first-quarter results. Year-over-year revenue growth of 33% and adjusted earnings-per-share growth of 85% is the kind of performance that makes investors happy campers.
The bigger story, though, is what the biotech's management team had to say about those results and what's coming up next. Here are five things you'll want to know from Vertex's Q1 conference call.
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1. Symdeko is off to a great start
Over one-fifth of Vertex's year-over-year revenue increase came from new cystic fibrosis (CF) drug Symdeko. The drug generated revenue of $34 million, and that's an impressive start. What's even more impressive is that Symdeko was only on the market for seven weeks during the quarter.
Vertex CEO Ian Smith said that the majority of payers in the U.S. are already providing coverage for the drug. While some patients are switching to Symdeko from Vertex's other CF drugs, Kalydeko and Orkambi, Vertex Chief Commercial Officer Stuart Arbuckle said that the biotech is also seeing patients who had not used previous therapies begin treatment with Symdeko.
The good news for Symdeko could get even better. Vertex expects to win European approval for the CF drug in the second half of 2018.
2. Why one triple-drug combo won't advance to phase 3 just yet
Perhaps the only negative in Vertex's entire Q1 update related to news that one of its triple-drug combos won't move into phase 3 clinical testing yet. The company reported phase 2 results for its combination of VX-561, VX-659, and tezecaftor. Did problems in this phase 2 study prevent the triple-drug combo from advancing to late-stage testing? Nope.
The issue, in this case, is that the FDA considers VX-561 a new chemical entity, even though it's basically a deuterated version of already-approved drug Kalydeco. As a result, the FDA wants Vertex to conduct more studies of VX-561 as a monotherapy and more studies of dose ranging of the drug.
Vertex really likes what it saw with the phase 2 study of the VX-561 triple-drug combo. The company still plans to move forward with testing the combo with the intent to ultimately win FDA approval as a once-per-day CF therapy.
3. Other triple-drug combos are zipping along
Despite the delay for the VX-561 combo, Vertex's other triple-drug combos are moving along quite nicely. The first patients have been dosed in the phase 3 study evaluating a combination of VX-659, tezacaftor, and ivacaftor.
Vertex also announced that it has initiated two phase 3 studies to evaluate VX-445, tezacaftor, and ivacaftor. One of those studies targets patients who have one copy of the F508del mutation and one minimal function mutation, while the other targets patients with two copies of the F508del mutation.
Investors will be glad to know that these studies should wrap up quickly. If all goes well, Vertex plans to prepare regulatory submissions for the VX-659 and VX-445 triple-drug combos in patients with one F508del mutation and one minimal function mutation based on data from a four-week primary efficacy analysis and safety data through 12 weeks. Regulatory submissions for the combos in patients with two F508del mutations will be based on four-week primary efficacy analysis and 24-week safety data.
There's also another reason why investors should be eager for the triple-drug combos to win approval. Vertex CEO Jeff Leiden said earlier this year that the newer combos should be more profitable than Kalydeco, Orkambi, or Symdeko. That's because Vertex renegotiated its agreement with Cystic Fibrosis Foundation Therapeutics Incorporated to pay lower royalties on its triple-drug combos.
4. What's coming next from the pipeline
Could more combo therapies of next-generation correctors for CF be on the way? Leiden said that the decision will come down to whether or not a given candidate is clearly better than the biotech's other triple-drug combos.
Vertex definitely hopes to receive good news from the experimental pain drugs in its pipeline. The company has already reported encouraging data for VX-150 in treating osteoarthritis and acute pain. Leiden said that data from phase 2 studies should be available later in 2018 and in early 2019. Based on those results, the biotech will decide how to move forward. Vertex also recently started a phase 1 study of VX-128 in treating pain.
Perhaps the most significant pipeline news outside of CF was that Vertex and partner CRISPR Therapeutics (NASDAQ: CRSP) plan to move with Phase 1/2 studies of gene-editing therapy CTX001 in treating beta-thalassemia and sickle cell disease. The clinical studies targeting beta-thalassemia should begin in Europe this year. Vertex and CRISPR will submit for U.S. approval to begin phase 1 testing of CTX001 in patients with sickle cell disease within the next couple of months. This is a big deal because the beta-thalassemia study will likely be the first testing of gene editing in humans ever.
5. The kinds of business development deals to expect
Vertex reported a cash stockpile, including cash, cash equivalents, and marketable securities, of nearly $2.5 billion at the end of the first quarter. Jeff Leiden said that the company will be active on the business development front. Vertex's cash and ability to generate even more provides plenty of flexibility for business-development efforts.
What kinds of deals might Vertex make? Leiden said to expect more agreements similar to the collaborations Vertex has forged with CRISPR Therapeutics and Moderna Therapeutics. Both of those deals involved upfront payments plus the potential for future milestone payments and royalties. Vertex also bought a stake in CRISPR Therapeutics.
Don't look for major acquisitions, though. Ian Smith said that the company prefers to look at earlier-stage assets. There's a reason why: Vertex still has plenty of growth opportunities ahead in its core CF market. And nobody is doing it better in CF right now than Vertex.
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Keith Speights has no position in any of the stocks mentioned. The Motley Fool recommends Vertex Pharmaceuticals. The Motley Fool has a disclosure policy.
