- Pfizer's new heart drug nearly quadrupled Wall Street sales expectations in its first full quarter of sales in the U.S., quickly carving out a spot in a therapeutic market that features rival therapies from Alnylam Pharmaceuticals and Ionis Pharmaceuticals.
- Vyndaqel posted $156 million in global sales across the three months of July, August and September, with $79 million coming from the U.S. market. Wall Street's consensus estimate was $21 million in U.S. sales, according to Evercore ISI analyst Umer Raffat, who also pointed out a faster-than-expected rate of diagnosis for the rare disease treated by Vyndaqel.
- Vyndaqel was approved in the U.S. in May to treat wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM). The Food and Drug Administration initially rejected the drug in 2012 as a therapy for familial amyloid polyneuropathy, while dozens of other countries approved it for that indication.
While Vyndaqel (tafamidis) sales were boosted by the U.S. launch, Pfizer's total revenues for the third quarter dropped 5% from a year ago.
But that decline may be acceptable and expected for the company, as it narrows its business focus to biopharmaceuticals. Pfizer shed its consumer healthcare unit on July 31 and expects to close a deal next year with Mylan to separate its Upjohn legacy business.
That will leave Pfizer as "a smaller, science-based company," CEO Albert Bourla said in a Tuesday statement. And that core biopharma business posted 7% year-over-year growth for the third quarter, according to the company.
Through the first nine months of 2019, sales of Vyndaqel totaled $259 million. Yet the third quarter surge isn't just due to growth in the U.S. market, SVB Leerink analyst Mani Foroohar wrote in a Tuesday note to investors.
Foroohar said the revenue spike comes from "robust growth in all markets, including ongoing TTR-CM launches in U.S. and Japan and increased use of Vyndaqel in Europe, likely driven by increased use in mixed phenotype patients."
Pfizer also noted it launched Vyndamax (tafamidis), a variant of Vyndaqel, in September. While Vyndaqel is taken once-daily as four capsules, Vyndamax is a single pill. The FDA approved both types in May.
Pfizer's therapy has a slightly different indication than the competing therapies in Alnylam's Onpattro (patisiran) and Ionis' Tegsedi (inotersen), both approved to treat peripheral nerve damage from hereditary ATTR.
The therapies are some of the most expensive in medicine, with average annual list prices set at $225,000 for Vyndaqel and an average of $450,000 for Onpattro or Tegsedi.
Pfizer's stock was up 3% in early morning trading.