Last month an FDA panel recommended that the watchdog agency approve the Lutonix device, which is designed to treat peripheral artery disease, voting unanimously that it is safe, effective and its benefits outweigh its risks.
John DeFord, Bard’s senior vice president of science, technology & clinical affairs, told analysts during a conference call yesterday that publication of the Levant 2 clinical trial comparing treatment with Lutonix to treatment with a non-drug-coated balloon is undergoing review at a "targeted journal."
"The authors informed us this week that they received communication from a targeted journal, which required revisions, as is typical in the process. The authors plan to respond in the coming weeks, and we’re pleased with the process and it’s moving forward, but we can’t predict the timing or the outcome here as it’s really outside of our control," DeFord said. "And though the panel was an important milestone, we’re focused on continuing to expand sizes and indications worldwide. We completed enrollment in our Levant 2 Japan study in June, and we expect to submit next year for approval."
Bard posted losses of -$119.4 million, or -$1.59 per share, on sales of $827.1 million during the 3 months ended June 30, paring losses by 26.1% on sales growth of 8.8% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were $2.06, up 22.0% over Q2 2013 and a full nickel ahead of expectations on Wall Street.
"Once again we exceeded our expectations for revenue growth this quarter. We continue to believe that executing our investment plan will accelerate the sustainable growth rate of the overall portfolio and put us in a position to provide revenue growth in the mid-to-high single digits with attractive returns for shareholders," chairman & CEO Timothy Ring said in prepared remarks.
CFO Christopher Holland yesterday said that Bard is raising its full-year sales and earnings guidance. The company now expects to post adjusted EPS of $8.25 to $8.35, up from $8.20 to $8.30, on constant-currency sales growth of 8%-9% (up from prior guidance of 6%-8%).
Third-quarter adjusted EPS are forecast in the $2.07 to $2.11 range, on constant-currency sales growth of 7%-9%, Holland said.
The strong results sent BCR shares up 0.2% today to $147.29 apiece as of about 10 a.m. Eastern.