What competition? Vertex touts Trikafta’s competitive edge after strong 2021

Vertex ended 2021 strong, crushing analysts’ sales expectations for the full year. CEO Reshma Kewalramani, MD says the company’s well-established position in the cystic fibrosis space, where Vertex expects to maintain its lead for years to come, is worth it.

Vertex captured $7.57 billion in product revenue for 2021, reporting a 22% year-over-year increase. For 2022, the company expects to achieve sales of $8.4 billion to $8.6 billion. For now, this growth is firmly tied to Vertex’s CF franchises.

The company’s forecast for 2022 suggests that “penetration of additional cystic fibrosis patients will occur faster than expected with increasing age and the full-year impact of reimbursements outside of the United States,” RBC Capital Markets’ Brian Abrahams wrote in a note to clients on Wednesday.

During its call on Wednesday, Vertex repeated its estimates that more than 25,000 patients could benefit from newcomer Trikafta and are not yet on treatment. The company divides these patients into three groups: those who have not yet started Trikafta in countries where the drug has recently been reimbursed, patients in territories where the drug has not been reimbursed, and younger patients, which Vertex aims to address with the future Trikafta. label extensions.

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Meanwhile, the $8.4 billion to $8.6 billion range presented by Vertex seems “notoriously conservative,” Evercore ISI’s Liisa Bayko wrote in a note to clients. “[W]We expect VRTX to beat and rise throughout the year,” she added.

Trikafta, for its part, carried the bulk of the sales weight last year, bringing in $1.69 billion for the final three months of 2021. The drug earned around $1.09 billion during the same period in 2020. Trikafta achieved sales of $5.69 billion in 2022. marking a blockbuster-worthy increase from the $3.86 billion achieved in 2020.

Former CF med Kalydeco proved to be the company’s next best seller, albeit by a significantly lower margin, with sales of $152 million in the fourth quarter. The drug made $684 million for the year. Orkambi earned $147 million for the quarter – down slightly from $215 million in 2020 – and $772 for the year, while Symdeko pulled in $80 million in the fourth quarter and $420 million for all of 2021.

Vertex is trying to diversify from its CF base, and analysts seem to share the company’s hopes for stage 1/2 type 1 diabetes candidate VX-880. This drug could potentially unlock a “multi-billion dollar opportunity, comparable to CF and almost entirely on the upside in our model,” RBC’s Abrahams said. CF forms the backbone of Vertex’s pharmaceuticals business, and investors have long pushed the company to diversify.

Vertex has also pinned its hopes on its gene-editing program for sickle cell disease and beta-thalassemia, CTX001, in its next commercial launch, Kewalramani said. The company sees “enormous potential” for the treatment, and Vertex has already kicked off preparations for launch ahead of global regulatory submissions expected later this year. The company is expanding market access, patient support and its physician teams, as well as finalizing its manufacturing and supply chain network, the company said on its earnings call.

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Still, when it comes to CF, Vertex are confident they can hold on to their top spot, Kewalramani said.

“More patients worldwide are being treated with a Vertex CFTR modulator today than ever before, and the vast majority of them are with Trikafta,” which has “remarkable” clinical trial data, the CEO said. . “If there is a drug that competes with Trikafta, it has to compete with Trikafta in clinical trials.

“It needs to have enhanced benefits and you need to have long-term data,” she added.

The only company that currently has it is Vertex, and Trikafta’s “most advanced” competitor is the triple combo of tezecaftor and experimental VX-121 and VX-561, which is in Phase 3 testing.

Kewalramani pointed to Trikafta’s recent real-world data, collected from more than 16,000 US patients, which showed the drug led to an 87% reduction in lung transplant risk, 77% fewer lung exacerbations and a 74% reduction in the risk of death.

That said, the company is “on the cusp of a critical external event that should settle the viability of VRTX’s dominance in CF…that’s ABBV’s tripled data,” Evercore’s Bayko said. The consensus opinion points to “lackluster” data from AbbVie, but “it would be a nasty surprise if the data were comparable to Trikafta,” the analyst added.

AbbVie’s combo, which is in stage 2 test, comes from the company purchase of the CF Galapagos pipeline for $45 million at the end of 2018.

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