HeartWare International Inc. (NSDQ:HTWR) closed 2009 on a high note, with soaring sales and slashed losses, even as it announced the early conclusion of enrollment in a clinical trial to gauge the effectiveness of its miniature heart pump (with some help from the Food & Drug Administration).
The Framingham, Mass.-based firm posted sales of $12.2 million during the three months ended Dec. 31, 2009, up a whopping 4,900 percent compared with $244,000 during the same period in 2009. Fourth-quarter net losses plunged 51.4 percent, to $1.9 million (or 176 cents per share) compared with $3.9 million (44 cents per share) during Q4 2008.
HeartWare‘s top line fared even better during the full year, soaring 7,180 percent to $24.2 million compared with $332,000 in 2008. Annual net losses were down 12 percent to $20.9 million ($2.15 per share) in 2009, compared with $23.8 million ($3.00 per share) during the prior year.
President and CEO Doug Godshall said the commencement of international sales of its left-ventricular assist device, designed to help weakened hearts pump during end-stage heart failure, in March of last year drove the turnaround. HeartWare won CE Mark approval in the European Union for its HVAD device in January 2009.
"Since our first international commercial sale in March 2009, we have continued to receive positive physician feedback — both in approved international markets, where physician acceptance continues to build, and also in the U.S., where the pace of enrollment in our clinical study accelerated toward year end," Godshall said in prepared remarks. "Today we have 20 sites implanting the HeartWare HVAD pumps internationally and, importantly, our U.S. bridge-to-transplant trial recently completed enrollment, paving the way for a submission to the FDA for pre-market approval in the second half of this year."
HeartWare said the results also got a boost from the failure of its defunct, $282 million merger with competitor Thoratec Corp. (NSDQ:THOR), which got the kaibosh from the Federal Trade Commission on anti-trust grounds.
Godshall said the company is doubling down on the HVAD, putting more investment behind marketing and customer service for the device and beefing up its reimbursement and patient outcome management efforts. Having netted about $59 million in a public offering earlier this month, he said, the company is also in good shape to develop its product pipeline. The company had cash and equivalents of $50.8 million on hand as of the end of the year, excluding the cash it brought in from the offering.
The HVAD device got an assist of its own from the FDA, which asked HeartWare to change the criteria for listing patients enrolled in its Advance trial.
Godshall said the federal watchdogs asked his company to change the study’s protocol to list as "enrolled" patients who signed on for the trial, instead of patients who signed on and met its inclusion and exclusion criteria. The study is examining whether the device is suitable as a so-called "bridge to transplant" therapy for patients with severe heart disease who are waiting for a heart transplant. HeartWare said the final two implants, slated to be done by Feb. 25, would mean that all 140 patients enrolled in the trial will be set to meet the trial’s endpoint of 180 days by August.
That pushes up the timeline for submitting a pre-market approval application to the FDA, which HeartWare said could happen as soon as early December. The company is also asking the FDA to expand the trial to additional patients and has applied for permission to conduct another study, of using the device as a so-called "destination therapy" for patients who aren’t eligible for a transplant. If the agency gives the go-ahead, that trial could begin during the second quarter, HeartWare said.