BioDelivery Sciences International, Inc. announced an updated financial guidance for full-year 2021. The company expects total net product revenues, including net sales of Belbuca, at the upper end of its previously provided guided range. The company also expects EBITDA to be above the earlier projection.
BioDelivery expects total net product revenues for full-year 2021 in the range of $165-$167 million, whose lower limit has been raised from the previous projection of $162-$167million. The new guidance indicates 6.1% year-over-year growth at the mid-point of the range.
BioDelivery currently has three FDA-approved drugs in its portfolio. While two products — Belbuca (for chronic pain) and Symproic (for opioid induced constipation) — are presently being marketed by the company, the third drug Elyxyb (for acute treatment of migraine) is expected to be launched in first-quarter 2022.
We note that the launch of Elyxyb marks BioDelivery’s entry into the neurology market. Elyxyb was approved by the FDA for acute treatment of migraine with or without aura in adult patients in May 2020.
BioDelivery expects global net sales of Belbuca for full-year 2021 in the range of $147-$148 million, whose lower limit has been raised from the previous projection of $144-$148 million despite the negative impact of the ongoing COVID-19 pandemic. The new guidance suggests an 8.4% year-over-year rise at the mid-point of the range.
The company now expects total operating expenses for 2021 in the range of $106-$110 million, down from the previous guidance of $115-$120 million. BioDelivery expects EBITDA for 2021 in the range of $40-$45 million, much higher than the prior expectation of lower than $40 million. These figures include the launch costs for Elyxyb.
Excluding Elyxyb launch costs, BioDelivery expects EBITDA for 2021 in the range of $45-$50 million, marking a rise from the lower limit of the previous guidance of $40-$50 million.
Shares of BioDelivery rose 6% following the above announcement. Yet, the stock has declined 24.5% in the past year in comparison with the
industry’s decline of 38.1%. Image Source: Zacks Investment Research
The company also discussed some other preliminary numbers. Per the press release, Belbuca achieved a 5% market share in total prescriptions (TRx) while Symproic gained 13% in TRx market share during the fourth quarter.
During fourth-quarter 2021, BioDelivery recorded Belbuca prescriptions of approximately 122,000, representing prescription volume growth of 8.8%, partially offset by the sale of Belbuca’s generic version by Alvogen.
In September 2021, BioDelivery filed a motion against Alvogen for marketing the generic version of Belbuca through compendia/price reporting services despite a court order barring Alvogen from launching the same. Last month, the company received a favorable opinion from the U.S. District Court of Delaware, allowing it to hold market exclusivity for Belbuca against Alvogen till 2032.
BioDelivery’s total Symproic prescriptions during the fourth quarter were up 5.3% year over year to approximately 19,000.
For the financial year 2022, BioDelivery expects to see growth in net sales for Belbuca following potential de-escalation of the pandemic situation, as patients start visiting physicians for treatment.
Zacks Rank & Key Picks
BioDelivery carries a Zacks Rank #4 (Sell) at present. Some better-ranked stocks in the overall healthcare sector include
Alkermes ( ALKS Quick Quote ALKS - Free Report) , AnaptysBio ( ANAB Quick Quote ANAB - Free Report) and BioNTech ( BNTX Quick Quote BNTX - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see . the complete list of today’s Zacks #1 Rank stocks here
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