Total 2021 Net Revenue expected in the range of
BELBUCA 2021 Net Sales expected to be in the range of
2021 EBITDA expected to be in the
“The fourth quarter was transformative for the company on many fronts. Our pain franchise, led by BELBUCA, once again demonstrated resilience in growth and strong cash flow generation, and prevailed in a critical patent case maintaining BELBUCA patent exclusivity against a potential generic competitor through December 2032,” stated
“We grew our BELBUCA revenues, managed operating expenses efficiently in the face of COVID and prepared the groundwork for launching ELYXYB, all while generating approximately
“We own three FDA-approved, patented drugs, our cash generation engine is robust, and coupled with our strong balance sheet, should enable us to continue investment in strategic growth drivers and maximize shareholder value,”
Base Business Remains Strong and Growing
“Despite the impact COVID-19 is having on new patient visits to physicians, we are pleased to see the strong performance of BELBUCA in the fourth quarter,” stated
During the fourth quarter of 2021, BELBUCA achieved Total Prescription (TRx) market share of 5.0%, a record for BDSI, and volumes were at an all-time high of 122,000 TRx. For the full year 2021, BELBUCA TRx volumes were up a solid 8.8% year-over-year despite headwinds reported earlier this year. Symproic® (naldemedine) similarly achieved an all-time high 13.0% TRx share and volumes of 19,000 for Q4 2021, an increase of 5.3% year-over-year.
“We announced further good news for our BELBUCA franchise on
Migraine Opportunity
In the fourth quarter, the Company prepared for the upcoming launch of ELYXYB, the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. “This will be our first entry into the adjacent and complementary market of neurology, representing a new source of future revenue growth. With projected peak sales outlook of
“We are enthusiastic to see our differentiated products continue to achieve record levels for both the fourth quarter and full year 2021, reflecting persistent excellent execution by the Company’s sales and marketing teams,” said
Updated full year 2021 Guidance
Total Company Net Revenue for 2021 is expected to be in the range of
BELBUCA Net Sales for 2021 are expected to be in the range of
Total Operating Expenses for 2021 are expected to be in the range
EBITDA for the full-year 2021 is expected to be in the
ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in
EBITDA excludes net interest, including both interest expense and interest income, provision for (benefit from) income taxes, depreciation, and amortization.
The Company's management and board of directors utilize this non-GAAP financial measure to evaluate the Company's performance. The Company provides this non-GAAP measure of the Company's performance to investors because management believes that this non-GAAP financial measure, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, EBITDA is not a measure of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, EBITDA should not be considered a measure of our liquidity.
ELYXYB INDICATION AND USAGE
ELYXYB is indicated in adults for the acute treatment of migraine with or without aura.
Limitations of Use: ELYXYB is not indicated for the preventive treatment of migraine.
ELYXYB IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events
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ELYXYB is contraindicated in patients with:
- Known hypersensitivity to celecoxib, any components of the drug product, or sulfonamides (4)
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
- In the setting of CABG surgery (4)
To minimize the potential risk for an adverse cardiovascular (CV) event in NSAID-treated patients, use ELYXYB for the fewest number of days per month as needed, based on individual treatment goals. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
Avoid the use of ELYXYB in patients with a recent myocardial infarction (MI) unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ELYXYB is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
NSAIDs, including ELYXYB, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with celecoxib. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.
Avoid the use of ELYXYB in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If ELYXYB is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs, including ELYXYB.
Long-term administration of NSAIDs, including celecoxib, the active ingredient in ELYXYB, has resulted in renal papillary necrosis and other renal injury.
No information is available from controlled clinical studies regarding the use of celecoxib in patients with severe renal impairment. The renal effects of celecoxib may hasten the progression of renal dysfunction in patients with preexisting renal disease.
Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month), including ELYXYB, may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.
NSAIDs, including ELYXYB, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet drugs (e.g., aspirin), SSRIs, and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.
Most common adverse reaction (at least 3% and greater than placebo) is dysgeusia.
These are not all the side effects associated with ELYXYB.
Please see Patient Information, Instructions For Use, Medication Guide and Full Prescribing Information for ELYXYB
(https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf)
© 2022 BioDelivery Sciences International, Inc. All rights reserved.
Contact:
646-597-6989
Bob@LifeSciAdvisors.com
Source:
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