RALEIGH, N.C., Nov. 03, 2021 (GLOBE NEWSWIRE) — BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported solid financial results for the third quarter ended September 30, 2021, including the following operational and performance highlights.
Key Business Highlights
- Net sales of BELBUCA® and Symproic® combined grew 7.5% year-over-year. This growth was driven by record BELBUCA net sales of $36.9 million, which increased 6.3%, and Symproic net sales of $4.1 million, which increased 20%.
- BELBUCA delivered an all-time high quarterly market share of 4.9%, despite the situation with Alvogen which was described in our 8K filing on September 21, 2021.
- Total BELBUCA prescriptions were over 121,000 during the third quarter, a new record high and representing year-over-year prescription volume growth of 7.7%.
- Total Symproic prescriptions were over 19,200 in the third quarter, delivering 7.6% year-over-year growth and reflecting record high TRx volume, record high NRx volume of over 11,100 leading to a record NRx share of 14.3%.
- Continued to achieve strong profitability, delivering $6.7 million of GAAP Net Income, an attractive 27% EBITDA margin in the third quarter of 2021, GAAP EPS of $0.07, as well as generating $7.0 million in operating cash.
- Acquisition of ELYXYB for the treatment of acute migraine closed on September 9, 2021.
“Sales of BELBUCA and Symproic remain solid as we prepare for additional revenue growth associated with the launch of ELYXYB in the first quarter of 2022. ELYXYB, with patent protection to 2036, diversifies our portfolio, takes advantage of the synergies between pain and neurology, and leverages our current commercial infrastructure to manage ELYXYB in a very efficient way,” stated Jeff Bailey, CEO of BDSI. “Moreover, we continue our business development activities for product acquisitions and licensing opportunities, especially in the Neurology space.”
Third Quarter 2021 Financial Results
Total Company Net Revenue for the third quarter of 2021 was $41.1 million, an increase of 4.2% compared to $39.4 million in the third quarter of 2020. Net sales of BELBUCA and Symproic combined grew 7.5% year over year.
BELBUCA Net Sales for the third quarter of 2021 were $36.9 million, an increase of 6.3% compared to $34.8 million in the third quarter of 2020. Third quarter 2020 net sales were positively impacted by the gross to net channel refresh.
Symproic Net Sales for the third quarter were $4.1 million, an increase of 20% compared to $3.5 million in the third quarter of 2020.
Other Revenue for the third quarter totaled $20 thousand of royalty revenue, compared to $1.2 million in the third quarter of 2020, which included royalty revenue of approximately $0.7 million and approximately $0.6 million of Bunavail net sales.
Total Operating Expenses for the third quarter of 2021 were $25.5 million, compared to $22.5 million in the third quarter of 2020.
GAAP Net Income for the third quarter of 2021 was $6.7 million, or $0.07 per share, compared to GAAP net income of $9.4 million, or $0.09 per share, in the third quarter of 2020.
EBITDA for the third quarter of 2021 was $11.1 million, or 27% of net sales, compared to $13.4 million or 34% of net sales, in the third quarter of 2020.
Non-GAAP Net Income for the third quarter of 2021 was $10.3 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets as compared to non-GAAP net income of $12.7 million in the third quarter of 2020, excluding the same items.
Cash Position: As of September 30, 2021, cash and cash equivalents were approximately $100.7 million, compared to $111.6 million as of December 31, 2020. The change in year-to-date cash of ($10.9) million reflects operating cash flow generation of $27.3 million, $11.9 million in share buybacks, the prepayment of $20.0 million of debt, as well as the $6.0 million upfront payment for ELYXYB and $0.4 million in transaction related costs. For the third quarter, total cash on hand decreased by $19.1 million versus June 30, 2021, with operating cash flow generation of $7.0 million being partially offset by $20.0 million used towards an early, penalty-free debt repayment of our term loan and a $6.0 million upfront payment to Dr. Reddy’s for ELYXYB, along with $0.4 million in transaction related costs. The $20.0 million pre-payment will result in approximately $4.4 million of interest savings over the course of the remaining loan period.
Financial Guidance
For 2021 financial guidance, the Company is lowering its full year 2021 total net revenue guidance range to $162 – $167 million from $170 – $180 million previously communicated. The situation with Alvogen is a factor contributing to our amended guidance. BDSI now expects BELBUCA net sales for 2021 to be in the range of $144 – $148 million dollars. The Company continues to estimate total operating expenses for the ongoing business to be in the range of $115 – $120 million, including pre-launch investments to support the first quarter 2022 launch of ELYXYB. EBITDA for the ongoing business, excluding ELYXYB, is projected to be at the lower end of the $40 – $50 million range in 2021. Following the acquisition of ELYXYB, total EBITDA is expected to be less than $40 million in 2021 due to the Company’s investments to prepare for the first quarter 2022 launch.
“We are investing in our future by entering into the attractive acute migraine space while driving the growth of our robust pain franchise,” stated Jeff Bailey. “We expect ELYXYB to be financially accretive within 24 months after its launch, and to be a differentiated and exciting new treatment option for both prescribers and patients. Our balance sheet remains strong and we will continue to invest to grow our current products and, through the establishment of a dedicated neurology sales force, we will be able to leverage our current infrastructure to manage the addition of ELYXYB in a very efficient way.”
ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of differentiated pain and neurology products and leverages its experienced sales and marketing organization to educate prescribers on their unique features. BDSI’s products address serious and debilitating conditions, including chronic pain, acute migraine and opioid-induced constipation.
