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Vertex (VRTX) Outperforms Industry Year to Date: Here's Why

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Vertex Pharmaceuticals Incorporated (VRTX - Free Report) enjoys a dominant position in the cystic fibrosis (CF) market. Vertex’s CF sales continue to grow, driven by its triple therapy, Trikafta/Kaftrio. New reimbursement agreements in ex-U.S. markets and label expansions in younger age groups are driving Trikafta/Kaftrio sales higher, a trend expected to continue in the second half of the year.

While CF remains the main area of focus, Vertex is also developing treatments for sickle cell disease (SCD), beta thalassemia (TDT), acute and neuropathic pain, APOL1-mediated kidney disease, type I diabetes and alpha-1 antitrypsin deficiency. It has earlier-stage programs in diseases such as muscular dystrophies.

This year is expected to be a catalyst-rich year for Vertex. Several important clinical milestones are expected over the next 12 months in its CF and non-CF portfolio.

So far this year, the stock has risen 21.6% against the industry’s 12.8% decline.

Zacks Investment Research
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Vertex is evaluating its CF medicines in younger patient populations and aims to have small-molecule treatments for most people with CF.

In the CF franchise, all eyes will be on the triple combination of vanzacaftor, a CFTR potentiator, deutivacaftor, a CFTR corrector and tezacaftor. Vertex is developing the triple combination CF regimen for patients 12 year and older. Vertex has completed enrollment in two pivotal phase III on the triple combination regimen. This new once-a-day combination medicine has the potential to offer enhanced patient benefits than Trikafta. It can potentially treat CF patients who have discontinued Trikafta or other Vertex CF medicines. It can also improve dosing (once daily) and lower the royalty burden. The studies are expected to be completed by the end of 2023 with phase III data readouts expected in early 2024.

Additionally, Vertex is developing a mRNA therapeutic, VX-522, in partnership with Moderna (MRNA - Free Report) for approximately 5,000 people with CF who cannot benefit from its CFTR modulators. Vertex and Moderna are conducting a single ascending dose (SAD) clinical study on VX-522, after the FDA cleared the investigational new drug application in December 2022. Vertex and Moderna expect to complete SAD and initiate the multiple ascending dose study in 2023.

Many of its non-CF candidates represent multibillion-dollar opportunities. Six of the programs are past the proof-of-concept stage.

Vertex has co-developed a gene-editing treatment, exa-cel, in partnership with CRISPR Therapeutics (CRSP - Free Report) , for two devastating diseases — SCD and TDT. Vertex and CRISPR Therapeutics have submitted a BLA to the FDA for exa-cel in SCD and TDT indications, with a final decision expected by Dec 8, 2023 (priority review) and Mar 30, 2024, respectively. Vertex and CRISPR Therapeutics’ submissions on exa-cel in the European Union and the United Kingdom are under review. Vertex expects exa-cel to be its next commercial launch. Vertex believes exa-cel has the potential to be a one-time functional cure for SCD and TDT patients, with an estimated patient population of approximately 32,000.

Investors are paying a lot of attention to pain asset VX-548, which, they believe, has blockbuster potential. VX-548, a novel first-in-class, non-opioid NaV1.8 inhibitor, is being evaluated in two pivotal phase III acute pain studies, one following bunionectomy surgery and the other following abdominoplasty surgery. The pivotal program is expected to be completed in late 2023 or early 2024. Vertex initiated a phase II study of VX-548 in diabetic peripheral neuropathy, a form of peripheral neuropathic pain, in 2022. The neuropathic pain study is also expected to be completed by the end of 2023. Data from these studies are expected in late 2023 or early 2024.

Zacks Rank and Stock to Consider

Vertex currently carries a Zacks Rank #3 (Hold).

A better-ranked biotech stock is Corcept Therapeutics (CORT - Free Report) , with a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 62 cents to 78 cents. The consensus estimate for Corcept’s 2024 earnings per share has also improved from 61 cents to 83 cents. Shares of CORT have climbed 61.6% so far this year.

CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.

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