BioDelivery Sciences International, Inc. (BDSI - Free Report) recorded adjusted earnings of 6 cents per share for second-quarter 2019 against the Zacks Consensus Estimate of a loss of 6 cents. In the year-ago quarter, the company had incurred an adjusted loss of 12 cents per share.
Revenues totaled $29.7 million, up 143.44% from the year-ago period figure and 50% sequentially. The uptick was mainly driven by higher sales of Belbuca. The top line also outpaced the Zacks Consensus Estimate of $25.3 million.
So far this year, shares of BioDelivery have gained 8.9% against the industry’s 2.5% decrease.
Quarter in Detail
BioDelivery’s marketed portfolio includes three drugs — Belbuca for chronic pain, Bunavail, for treating opioid dependence and Symproic for opioid induced constipation. The company added Symproic to its portfolio by acquiring U.S. commercial rights to the drug from Japanese pharma company, Shionogi.
Net product sales were up 161% year over year to $28.1 million.
BioDelivery’s chronic pain drug, Belbuca, generated revenues of $24.1 million in the quarter, up 29% sequentially. On a year-over-year basis, the top line surged 147%. Sales of the drug have witnessed a strong uptrend since 2018. The momentum continued into the first half of 2019. This trend is likely to continue in the rest of the year. Notably, the company re-acquired worldwide rights to Belbuca in early 2017 from Endo International (ENDP - Free Report) .
Symproic sales in the second quarter, the first quarter after the acquisition and launch of the drug in May, added $3.2 million to the top line.
Sales of Bunavail, indicated for the treatment of opioid dependence, were $0.82 million in the second quarter, reflecting a decline of 19.5% year over year.
Meanwhile, operating expenses increased 47.6% to $22 million and 29.4% sequentially. The increase was due to continued investment in commercialization efforts for Belbuca and acquisition of Symproic.
BioDelivery recorded all-time high prescription volumes of almost 80,000 prescriptions for Belbuca in the second quarter. Prescription volume for Belbuca expanded 23% sequentially and 125% year over year. The company added approximately 6,579 new patients to Belbuca treatment during the quarter, an all-time high. In the first quarter, it had added 1,260 new patients. Management seems confident about Belbuca’s strong performance in the second half of 2019. Moreover, the settlement of the patent litigation with Teva Pharmaceuticals (TEVA - Free Report) in 2018 will keep generic competition at bay till mid-2027.
BioDelivery has been expanding the preferred coverage for Belbuca by adding it to the list of several pharmacy benefit managers. In July, the company announced that several prominent regional U.S. insurance plans enhanced Belbuca’s coverage to preferred status or initiated coverage for the drug. These enhancements have brought additional six million patients under coverage with access to Belbuca. These deals along with the addition of Belbuca to a preferred formulary of Cigna Healthcare — the managed care division of Cigna Corporation (CI - Free Report) — in February gave more than 165 million covered patients, representing 90% of the U.S. commercial insurance market, access to Belbuca.
Please note that in 2017, Aquestive Therapeutics had filed a complaint for patent infringement by Belbuca. Earlier this month, United States District Court for the Eastern District of North Carolina ruled in favor of BioDelivery in the litigation related to Belbuca. However, the ruling allows Aquestive to re-file a similar complaint against Belbuca. This ruling may have led to a decline in share price in pre-market trading.
BioDelivery raised its 2019 guidance for total revenues to the range of $101-$105 million from $92-$100 million predicted earlier. This upside can be attributed to the strong demand for Belbuca and addition of Symproic to the company’s commercial portfolio.
Following the encouraging performance of Belbuca in the second quarter, the company again raised guidance for the drug’s sales. Sales of Belbuca are expected to be between $90 million and $93 million compared with $83 million and $88 million anticipated earlier. Symproic sales guidance was maintained in the $7-$9 million band.
Furthermore, the company anticipates combined sales of Belbuca and Symproic to reach $425 - $500 million over the long term.
BioDelivery currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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