Acadia Pharmaceuticals Inc., of San Diego, said net sales grew in the third quarter to $94.6 million, a 62% increase over the same period last year. Net sales guidance for the year rose from $330 million to $340 million. Wainwright analyst Andrew Fein said in a report that he "continue[s] to be encouraged by Nuplazid [pimavanserin] commercial traction with capacity for continued growth. Specifically, with management's mention of current mid-to-high teens market penetration in Parkinson's disease psychosis (PDP), we believe the growth opportunity remains far from saturated for this patient population. We therefore support continued education efforts in PDP including the integrated consumer awareness campaign along with direct-to-consumer commercial initiatives." As of Sept. 30, Acadia had cash and investments totaling 683.8 million.
Amag Pharmaceuticals Inc., of Waltham, Mass., reported third-quarter sales of Makena (hydroxyprogesterone) of $34.3 million as compared to consensus estimates of $37.8 million. Feraheme (ferumoxytol) sold $44 million and Intrarosa (prasterone) $5.6 million, both aligned with consensus. Management lowered 2019 guidance for revenues to a range of $320 million to $330 million, but raised guidance for the GAAP operating loss (-$278 million to -$268 million), and adjusted. EBITDA (-$75 million to -$65 million). Adjusted earnings before interest, tax, depreciation and amortization of -$8.3 million was slightly better than the consensus of -$13.5 million, driven primarily by lower selling, general and administrative expenses, noted Leerink analyst Ami Fadia in a report. Last week, an FDA adcom voted 9-7 to recommend that Makena, which had received accelerated approval for use in preterm birth eight years ago, should be removed from the market after a confirmatory study failed to show benefit. (See BioWorld, Oct. 30, 2019.)
United Therapeutics Inc., of Silver Spring, Md., reported third-quarter revenue of $401.5 million. Wainwright analyst Andrew Fein said the company is "losing [its] grip on [its] pulmonary arterial hypertension franchise [due to generic competition] and lacking an anchor in the developmental pipeline." Among United's marketed products, Remodulin (treprostinil pump) sold $168.3 million, Tyvaso (treprostinil inhaled) $110.8 million, and Orenitram (treprostinil extended release tablets) $62 million.