Tarsus Shelves TP03 Filings In Europe And Japan, Citing Most-Favored-Nation Pricing Rules
The eye-care drugmaker also lifted its 2026 Xdemvy sales outlook to $715 million to $730 million after third-quarter sales of $194.6 million.
Tarsus Pharmaceuticals, which sells the Demodex blepharitis eye drop Xdemvy, has decided to defer regulatory filings for its TP03 drug in Europe and Japan because of most-favored-nation pricing rules, Chief Financial Officer Jeff Farrow said on the company's earnings call Tuesday.
Europe and Japan on hold
Farrow said that, "similar to other companies," Tarsus made the call "in light of the current implications of most favored nation regulations." In China, he said, the company's partner has launched TP03.
Tarsus is a commercial-stage biopharmaceutical company; Xdemvy is its marketed product, and TP03 is the same active ingredient behind it, lotilaner, according to its annual report profile.
A higher Xdemvy outlook
Farrow said Xdemvy net product sales were $194.6 million in the third quarter. He put the 2026 sales outlook at $715 million to $730 million, citing stronger patient demand, deeper use by eye care professionals and better returns on advertising.
Chief Commercial Officer Neera Klase said weekly prescriptions hit an all-time high in the quarter and that the momentum has continued into the fourth quarter. She said the company is adding $5 million to direct-to-consumer spending, bringing the full-year total to about $95 million.
The company also booked $632 million of acquired in-process research and development charges in the quarter, Farrow said: $81 million for Irenix and $551 million for Alkias. Cash and equivalents ended the quarter at about $310 million.
Taking consensus "with a grain of salt"
An analyst from Jefferies noted that consensus has sales at $900 million next year, then $1.1 billion in 2028 and $1.25 billion in 2029, reaching $2 billion only in 2035. The analyst argued that implies growth must slow sharply.
Farrow replied that the company has not given specific guidance on its peak. "Consensus might have us at 2035 for the $2 billion peak," he said, "so I would take that with a grain of salt as well." Klase said she is confident in Xdemvy's potential to exceed "$2 billion plus" in peak annual sales.
Pipeline dates
Farrow said top-line results for TP04 in ocular rosacea and TP05 in Lyme disease prevention are expected in the first half of 2027. Tarsus's market value was $3.4 billion as of the report on Tuesday.
Top-line results for TP04 and TP05 are both due in the first half of 2027, Farrow said.
