Vertex 第三季度营收 34.4 亿美元，povetacicept 待 FDA 月底决定

With its latest earnings report, Vertex Pharmaceuticals generally met Wall Street forecasts while easing some worries around its burgeoning line of kidney disease drugs. 

Vertex recorded $3.44 billion in revenue from July through September, a 12% increase compared to the same three-month period from the year prior. More than 95% of that total came from the company’s arsenal of cystic fibrosis medicines. The newest addition, Alyftrek, posted $706 million, beating the average analyst estimate by more than $50 million.

The performance outside of cystic fibrosis was more mixed. Vertex’s sickle cell therapy Casgevy surpassed expectations by bringing in almost $100 million, whereas the $58 million from its non-opioid pain drug Journavx again fell below analyst predictions. Journavx, notably, was dinged by one-time rebate accounting, so the “softer” quarter shouldn’t raise major concerns about the product, according to RBC Capital Markets analyst Brian Abrahams.

In a note to clients, Abrahams wrote that the “solid” performance from Vertex’s cystic fibrosis drugs “underscores one of the steadiest, high-margin, and likely most durable core large biopharma franchises.” Vertex slightly upped its annual revenue guidance on Monday afternoon, to a range of $13.15 billion to $13.25 billion.

Company shares, meanwhile, were down about 3% by mid-morning Tuesday. In his own note, David Risinger of Leerink Partners pointed out that Vertex’s earnings per share this quarter were 4% below consensus. The operating and financing costs associated with Crinetics — an endocrine drug developer that Vertex just purchased for $10 billion — also put pressure on near-term earnings.

One of the bigger pieces of “good news,” according to Risinger and others, is that company leaders expressed confidence in their ability to launch Vertex’s first kidney product. The Food and Drug Administration could approve that medicine, “povetacicept,” by the end of the month as a treatment for a rare, progressive disease known as IgA nephropathy.

On an earnings call, Vertex’s Chief Commercial Officer Duncan McKechnie said the field team for povetacicept — which is often called “pove” for short — is “fully hired, trained and ready to go.” More than 90% of that team has “deep nephrology experience,” he added, and many have been engaging with and educating nephrologists about this disease since early in the year.

But being marked as an important growth driver has also put a magnifying glass on the potential obstacles to pove’s commercial prospects. For example, a citizen’s petition filed in late October asked the FDA to, for safety reasons, require regular monitoring of antibody levels for patients taking the drug, as well as guidance for managing low levels. Two similar medicines are already available, too.

Additionally, Vertex wants to provide pove as a highly concentrated, low volume shot delivered about once a month via an at-home autoinjector. Developing and scaling the manufacturing for that kind of product is often challenging.

Still, Vertex executives affirmed their conviction. With the FDA’s decision deadline fast-approaching, “we are 100% ready” to sell the product and “are incredibly excited to bring pove to patients,” McKechnie said.

The company “essentially gave bulls what they wanted to hear,” wrote Carter Gould, an analyst at Cantor Fitzgerald, in a note to clients.

“Given that this was arguably one of the last opportunities to potentially reset expectations around approval or the label ahead of the [decision deadline], management's repeated expressions of confidence should be viewed as strongly encouraging,” Gould added.

Earlier this year, when Vertex reported key late-stage data for pove, Gould described the results as “the first major step” to unlocking a renal franchise that could exceed $10 billion in peak annual sales. Such a franchise would go “a long way toward differentiating Vertex’s growth profile [versus its] larger-cap peers.”

Another core piece of that franchise is inaxaplin, which is in testing as a treatment for kidney disease caused by mutations in a gene called APOL1. Analysts noted that Vertex leadership sounded confident in an upcoming trial readout for inaxaplin — another “potentially major catalyst” for the company’s stock, according to Christopher Raymond of Raymond James.