After racking up not one but two FDA approvals last year, Epizyme’s freshly minted cancer med Tazverik hit the market with big sales expectations. The pandemic blunted that trajectory, in a story familiar to many companies that launched new drugs in 2020.
But analysts think Tazverik’s slow uptake may run deeper than COVID-19.
Tazverik snagged $4.5 million in the fourth quarter, a 33% increase over the $3.4 million it generated in the third quarter. After launching in February of 2020, the EZH2 inhibitor managed to rake in $11.5 million for the full year. While the company says it’s pleased with that performance in light of COVID-19, Tazverik’s sales came nowhere near the heights analysts were predicting last winter.
The drug's growth in epithelioid sarcoma, the rare soft tissue cancer for which the drug was first approved last January, started to “plateau” in the second half of the year, Chief Commercial Officer Vicki Vakiener said during the company's earnings call this week.
Meanwhile, new treatment starts for all therapies in the drug’s second indication—relapsed or refractory follicular lymphoma—continued to hover 20% to 30% below pre-COVID-19 levels in the fourth quarter, she said.
The other major hurdle, to hear Vakiener tell it, was a lack of face-to-face interaction with physicians. When the drug was approved in epithelioid sarcoma, the company had a runway of about two months before the full effects of the pandemic set in. Its follicular lymphoma launch, which followed an FDA green light in June, has been “almost entirely virtual,” she said.
Epizyme has kicked off educational and promotional programs, virtual speaker events, workshops and more to target physicians in the increasingly digital pandemic era. It’s also teamed up with patient advocacy groups and invested in a mix of traditional, online and social media to help get the word out, Vakiener said.
Those efforts have borne fruit, too, with the company reporting a more than 50% increase in new prescribing accounts from the third quarter.
But Tazverik’s launch could have problems beyond COVID-19, analysts figure.
The drug is approved for EZH2-positive follicular lymphoma patients who’ve tried at least two other therapies, but it's also cleared for other patients who don't have satisfactory alternatives. It's a label that can "require some explanation," Vekiener admitted, but it does open the drug up for a bigger population.
Still, the drug works best in follicular lymphoma patients with EZH2 mutations, SVB Leerink’s Andrew Berens wrote in a note to clients this week. And despite that fact, Epizyme is too “laser focused” on a strategy of promoting the drug for patients who either don't have the mutation or haven't been tested for it, the analyst figures.
The strategy of focusing beyond EZH2 mutations doesn't just overlook the drug's natural target market; it doesn’t seem to be winning over physicians, either, Berens added.
In fact, Tazverik has charted the most growth in third-line and later patients. Berens figures that means doctors are primarily interested in using the drug “in a more targeted manner for patients that would derive the largest benefit.”
Earlier this month, the National Comprehensive Cancer Network amended its guidelines to endorse Tazverik in patients whose EZH2 status hasn’t been tested—a move that would seem to support Epizyme's approach, but is “unlikely to materially change the addressable market for the drug,” Berens wrote.
His team predicts peak Tazverik sales will land below consensus at $551 million by 2029, working off the theory that it will mainly be used in patients with EZH2-positive tumors, rather than the wild-type and untested patients Epizyme is also pursuing.
Overall, Epizyme totted up revenues of $8.4 million for the fourth quarter, with full year sales landing at $15.8 million.