BioDelivery Sciences beats Q2 rev estimates, misses on EPS

Shares in BioDelivery Sciences International (NSDQ:BDSI) fell today after the pharmaceutical company beat sales estimates but missed earnings expectations on Wall Street with its second quarter results.

The Raleigh, N.C.-based company posted a net loss of -$14.9 million on sales of $8.7 million for the 3 months ended June 30, paring losses by 9.7% on sales growth of 75% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were -27¢, behind earnings estimates on The Street. Analysts were looking for sales of $8.5 million.

“The U.S. currently faces a very serious crisis with regard to prescription opioid abuse, addiction and overdose.  Our two buprenorphine-containing products provide important options to address the needs of those with chronic pain and opioid dependence, and we believe this is becoming increasingly recognized by healthcare providers, and that these dynamics are likely aiding our commercial performance with Belbuca,” president & CEO Mark Sirgo said in prepared remarks.  “Our strong start with our focused commercial effort behind Belbuca continued in the second quarter, with solid 44% growth in Belbuca net sales to $6.6 million compared to net sales of $4.6 million in the first quarter.  This is accentuated by sales from May onward that exceeded the previous sales peak reached by our former commercial partner Endo in December 2016. The increasing number of both prescriptions and number of Belbuca prescribers provide us with the confidence that our commercial strategy is working, and we anticipate continued growth. We also believe that the addition of government payers, such as Medicare Part D, which represents nearly 40% of the total prescriptions for long-acting opioids, provides further opportunity for growth as we look ahead to 2018.”

“We also achieved important progress with our Belbuca licensing efforts outside the U.S.  Our second quarter marketing approval for Belbuca by Health Canada was followed shortly thereafter by our licensing agreement with Purdue (Canada) for the licensing, distribution, marketing, and sale of Belbuca in Canada.  We anticipate the launch will take place early next year.  Beyond this agreement, we are focused on advancing toward additional commercial transactions for ex-U.S. rights to Belbuca this year, which will further support sustained future growth and our expansion strategy for this important product,” Sirgo added.

“Our cash on hand, in combination with expected Belbuca and Bunavail revenue, provide us the capital runway to support our current operating plan into the second half of 2018.  In addition, this runway does not include our ability to access up to an additional $30 million from our current CRG loan, the availability of which is dependent upon BDSI achieving certain funding conditions.”

BDSI shares were trading at $2.92 apiece today in morning activity, down -7.1%.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

DeviceTalks Boston 2018 is Bigger and Better than ever! Join us Oct. 8-10 for the 7th annual DeviceTalks Boston, back in the city where it all began. DeviceTalks offers three days of world-class education, networking, and a technology exhibition featuring the leading companies in the industry. Early Registration is now open.