The Framingham, Mass.-based heart pump maker reported losses of -$22.0 million, or -$1.33 per share, on sales of $53.1 million for the 3 months ended Dec. 31, 2013. Although that represents whopping sales growth of 62.4%, it’s a slight increase in net losses and well ahead of Wall Street’s forecast, even accounting for 1-time items. Adjusted losses per share were -92¢, compared with the -79¢ consensus on The Street.
Full-year losses were -$52.0 million, or -$3.69 per share, on sales of $207.9 million, representing a 32.4% loss reduction on 87.5% sales growth. But adjusted losses per share again eclipsed the outlook on The Street at -$3.24 per share, compared with the -$3.13 analysts were looking for.
"We experienced strong market adoption of the HeartWare ventricular assist system during our first full year of U.S. commercialization, with nearly 1,000 units sold and a total of 96 U.S. customers at the close of the year," president & CEO Doug Godshall said in prepared remarks. "In addition, we continue to receive enthusiastic support from markets outside of the U.S., with the addition of 28 international customers in new and existing markets. We are proud to have finished the year with 230 customers worldwide, an increase of nearly 50% in 2013."
"Our strong commercial growth was complemented by advances made in the clinical development of the HeartWare system," Godshall added. "During 2013, we initiated enrollment in the U.S. for our supplemental cohort study for destination therapy, received approval to commence enrollment in our trial in Japan, and we obtained conditional approval from the FDA for our U.S. thoracotomy trial. We are eagerly anticipating the upcoming initiation of first-in-human testing of our next generation MVAD pump and Pal peripherals, which is expected to precede the commencement of a 63-patient, CE Mark study at 9 international hospital sites.
"The acquisition of CircuLite, developer of the Synergy circulatory support system, in December 2013, provides an opportunity for us to expand our core business into the partial-support market segment, through the treatment of heart failure patients who are less sick," he said. "Our team is working diligently to make refinements to this device in order to position the Synergy system for re-launch at select European sites and to enhance the Synergy endovascular system when it enters the clinic."
HTWR shares were down 2.8% to $96.25 apiece as of about 1 p.m. today.