Rising Kalydeco (ivacaftor) sales carried Vertex Pharmaceuticals Inc.'s second quarter revenue 20 percent higher, giving the company confidence to raise projected sales of the cystic fibrosis (CF) drug as it anticipates expanding its geographic reach and label to reach additional patients.
Despite higher net losses, the company's consensus-beating performance boosted shares (NASDAQ:VRTX) 7.8 percent, or $9.84, to $135.46 by the close of trading Thursday.
Net sales of Kalydeco hit $154.9 million during the quarter, a 37 percent increase from the $113.1 million in sales the drug logged during the second quarter of 2014. Contributions from the hepatitis C drug Incivek (telaprevir) contributed $11.2 million, rounding out total quarterly revenue of $166.1 million.
Vertex now expects full-year Kalydeco net revenues of $575 million to $590 million in 2015. The company's prior range, first provided on Jan. 28, was for net revenues of $560 million to $580 million for the year.
Vertex's second quarter net loss of $188.8 million, or 78 cents per share, compared with a year-earlier loss of $159.4 million, or 68 cents a share, as it ramped up expenditures to launch Orkambi, a new CF drug approved by the FDA earlier this month that combines Kalydeco with lumacaftor to treat patients, 12 and older, with the homozygous F508del mutation. (See BioWorld Today, July 6, 2015.)
Vertex CEO Jeff Leiden called the drug's approval "a big step forward" in meeting the company's goal of treating more CF patients, a mission the company is also advancing through development of VX-661, a CF transmembrane conductance regulation (CFTR) corrector candidate being tested in combination with ivacaftor in four ongoing pivotal phase III trials. Vertex also plans to move a "next-generation" CFTR corrector into the clinic by the end of 2015.
Though convinced by projections of solid Orkambi uptake, H.C. Wainwright & Co. analyst Andrew Fein expressed concern over medium-term threats to the drug's potential commercial success. Inability to predict clinical response to the drug – Vertex has said it will have a wholesale acquisition price of $259,000 for a year of treatment – and "the proliferation of viable competitors" could both "begin to eat away at the Orkambi share in the medium term," he wrote in in Thursday earnings update.
As of June 30, Vertex had $1 billion in cash, cash equivalents and marketable securities
In other earnings news:
Acorda Therapeutics Inc., of Ardsely, N.Y., reported that sales of Ampyra (dalfampridine) continue to grow, rising 21 percent since the second quarter of 2014 to hit $105.5 million during the second quarter of this year. The company recorded net income of $1 million in the second quarter, or 2 cents per share, as compared to $4.7 million in the second quarter of 2014. It reported having $301.7 million in cash and cash equivalents as of June 30. Acorda shares (NASDAQ:ACOR) closed 45 cents higher on Thursday, at $34.23.
Alexion Pharmaceuticals Inc., of Cheshire, Conn., said sales of its lead product, Soliris (eculizumab), grew to $636 million, a 24 percent increase as compared to $512.5 million for the same period in 2014. The company reported diluted earnings per share for the second quarter of 83 cents, impacted by acquisition and restructuring costs resulting from its $8.4 billion purchase of Synageva Biopharma Corp. Net income was $170.2 million, vs. $166.5 million in the year-ago quarter. The company reported cash and cash equivalents of $1.3 billion. Alexion shares (NASDAQ:ALXN) closed 53 cents higher on Thursday, at $199.29. (See BioWorld Today, May 7, 2015.)
Alkermes plc, of Dublin, reported second quarter revenue of $151.4 million, compared to $153.4 million for the same period in the prior year. Net losses totaled $46.1 million for the quarter compared to net income of $3.7 million during the second quarter of 2014. At June 30, Alkermes had cash and total investments of $832.4 million. Shares (NASDAQ:ALKS) closed Thursday down 86 cents at $67.53.
Depomed Inc., of Newark, Calif., added some drama to Thursday's earnings roll, rejecting an unsolicited bid by Dublin-based Horizon Pharma plc. while simultaneously reporting record sales and cash flow during the second quarter. The company's sales reached $94.3 million, as compared to $28.2 million in the year-ago second quarter, and the firm raised its guidance for 2015 revenue to between $320 million and $340 million from an earlier $310 million to 335 million, based on strong sales of products from its Nucynta (tapentadol) pain drug franchise, acquired from New Brunswick, N.J.-based Johnson & Johnson earlier this year. The company reported cash and equivalents of $122.6 million as of June 30. Depomed shares (NASDAQ:DEPO) closed down $1.34 at $30.53 on Thursday. (See BioWorld Today, Jan. 20, 2015, and July 8, 2015.)
Dyax Corp., of Burlington, Mass., reported second quarter sales of $$26.4 million, as compared to $19.6 million for the comparable quarter in 2014, with revenue primarily from sales of Kalbitor (ecallantide). The company said it expects quarterly and annual revenues from the drug to fluctuate primarily due to variability in the rate at which individual patients utilize it to treat acute hereditary angioedema attacks. The company saw a net loss of $8.4 million for the second quarter vs. a loss of about $3.1 million in the second quarter of 2014. It reported cash, cash equivalents and investments of $394.2 million as of June 30. Shares (NASDAQ:DYAX) fell 23 cents to $24.03.
Theravance Inc., of South San Francisco, somewhat disappointed shareholders by the commercialization and financial management-focused company's results, sending its shares (NASDAQ:THRX) down 8.7 percent, or $1.36, to a $14.26 close on Thursday after reporting a loss of $7.8 million, or 7 cents per share, during its second quarter, missing analyst estimates by 1 cent. Despite the losses, Theravance management pointed to progress in the company's ongoing evolution in the wake of the mid-2014 separation of its late-stage partnered respiratory assets into the independent company Theravance Biopharma in mid-2014. During the second quarter of 2015, its total revenue was $10.7 million, which primarily resulted from royalties of $13.9 million from growing net sales of Relvar/Breo Ellipta (fluticasone furoate/vilanterol) and Anoro Ellipta (umeclidinium/vilanterol) by London-based Glaxosmithkline plc. Theravance reported having cash and cash equivalents, short-term investments and marketable securities of $229.3 million as of June 30.
Vanda Pharmaceutical Inc., of Washington, said its total second quarter revenues grew 25 percent to $27.6 million, as compared to $10.9 million during the second quarter of 2014. Sales included $17.6 million from antipsychotic drug Fanapt (iloperidone), while sales of Hetlioz (tasimelteon), the company's treatment of non-24-hour sleep-wake disorder, which affects the majority of totally blind individuals, rose to about $10 million, as compared to $1.6 million in the second quarter of last year. The company booked a net loss of $5.4 million, or 13 cents per share during the quarter, a 75 percent decrease as compared with its net loss of $21.6 million, or 64 cents per share, for the same period in 2014. Vanda shares (NASDAQ:VNDA) rose 93 cents to close at $12.07 on Thursday.