Pfizer’s heart drug tafamidis, now marketed as Vyndaqel and Vyndamax, landed on the scene bearing blockbuster expectations. And those expectations might just be too low.
After polling a dozen cardiologists, one team of analysts figures the Street's 2024 sales estimate of $1.5 billion should move up a notch—or several.
Cantor Fitzgerald analyst Louise Chen and her team made that comment in a Tuesday note to investors. Their reason? The Pfizer treatment's lower cost compared with its eventual rivals, for one thing. But, more important is a large population of patients with ATTR cardiomyopathy—1 million in the U.S. alone—that may be largely untapped now, but probably won't remain so for long.
“The cardiologists were highly confident that there will be a significant increase in treating both familial/hereditary and wild-type ATTR cardiomyopathy (ATTR-CM) over the next 12 months,” Chen said.
Some 100,000 U.S. patients suffer from the disorder, but the diagnosis rate is less than 1%, per Pfizer’s estimate. But physicians Cantor interviewed believe that the actual patient population is far larger. By Cantor’s calculation, patients with wild-type ATTR-CM could number around 600,000 to 700,000, and up to 200,000 U.S. patients could be living with the hereditary form of the disease.
The lack of ATTR-CM treatment options and the use of invasive heart biopsies to diagnose it have held down diagnosis rates, Angela Hwang, group president of Pfizer Biopharmaceuticals, said on the company’s first-quarter earnings call in April.
But Pfizer is determined to change that by using other “symptom recognition tools that will get physicians to think about cardiomyopathy in patients who until now may have been misdiagnosed,” Credit Suisse analyst Vamil Divan said in a May 15 note, after a lunch with Pfizer management, including CEO Albert Bourla and Hwang. The company is looking to drive diagnosis rates well above the 30%-40% level seen with other rare diseases, according to Divan.
One way to do that is by increasing noninvasive diagnostic methods such as scintigraphy. About half of the doctors Cantor interviewed use scintigraphy to diagnose ATTR-CM, but these cardiologists already treat the disease routinely and are familiar with Vyndaqel, and Alnylam’s and Ionis’ rival meds Onpattro and Tegsedi, according to Cantor’s survey criteria.
Still, these physicians expect the use of scintigraphy will increase. Over the next 12 months, they expect to increase their treatment of patients with hereditary ATTR-CM by 75% and wild-type by 83%, according to Cantor.
When compared with those two competitor injections that list at $450,000 a year, the Pfizer meds are pills that come with a far cheaper list price of $225,000 per year.
Combine that with a winning label on efficacy and safety, and Cantor’s Chen figures peak sales of Vyndaqel/Vyndamax could be “meaningfully higher” than the $1.5 billion consensus. And according to Credit Suisse’s Divan, “it appears that Pfizer may have much higher internal revenue expectations” than the forecast as well.