BioDelivery Sciences Reports Strong Q1 2020 Results
First Quarter Total Company Net Sales Increased 94% versus Prior Year to
First Quarter BELBUCA® Net Sales Increased 79% versus Prior Year to
Conference Call and Webcast Scheduled for
Key Business Highlights
Total Companynet revenue for the first quarter increased by 94% versus the prior year period to a record level of $38.3 million. This growth was driven by BELBUCA sales of $33.5 million, an increase of 79% versus the prior year period, and Symproic® sales of $4.2 million.
- Total BELBUCA prescriptions reached an all-time high of 99,400 during the first quarter, representing year-over-year prescription volume growth of more than 52%.
- Total Symproic prescriptions were more than 16,100 in the first quarter, representing growth of 19% versus the prior year period.
- Achieved record number of unique prescribers during the quarter for both BELBUCA and Symproic.
- Continued to expand BELBUCA Medicare patient access with the addition of more than two million covered lives, the vast majority of which have preferred access to BELBUCA, through a national PBM.
- Expanded BELBUCA commercial coverage within two important regional plans representing nearly 900,000 lives that can receive BELBUCA without being required to first fail two CII long-acting opioids.
- Strong financial position driven by performance and positive cash flow of
$6.7 millionin the quarter.
“I am very pleased by the success and momentum we achieved during the first quarter,” stated
First Quarter 2020 Financial Results
Total Company Net Revenue for the first quarter of 2020 was
BELBUCA Net Sales for the first quarter of 2020 were
Symproic Net Sales for the first quarter were
BUNAVAIL Net Sales for the first quarter were
Total Operating Expenses for the first quarter of 2020 were
GAAP Net Income for the first quarter of 2020 was
EBITDA in the first quarter of 2020 was
Non-GAAP Net Income for the quarter was
Cash Position: As of
2020 Net Sales Guidance:
Given the uncertainty surrounding the COVID-19 pandemic, the Company is withdrawing its 2020
Conference Call & Webcast Details
BioDelivery Sciences will host a conference call and webcast today, May 7, 2020, at 4:30 p.m. ET to present first quarter 2020 results and to provide a business update. Dial-in details are as follows:
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 Securities and Exchange Commission. Actual results (including, without limitation, the continued growth in BELBUCA net sales and total company net revenue in 2020 may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2019 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
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
Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense, amortization of intangible assets, amortization of certain warrant discount costs, and the financial impact of certain one-time items that are non-recurring, including the impact of the discontinuation of marketing of BUNAVAIL.
EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes and depreciation and amortization.
The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of the Company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity.
A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
© 2020 BioDelivery Sciences International, Inc. All rights reserved.
Director of Investor Relations
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||70,613||$||63,888|
|Accounts receivable, net||45,114||38,790|
|Prepaid expenses and other current assets||2,600||3,769|
|Total current assets||133,330||117,759|
|Property and equipment, net||1,995||2,075|
|License and distribution rights, net||58,576||60,309|
|Other intangible assets, net||—||47|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||60,931||$||53,993|
|Total current liabilities||60,931||53,993|
|Notes payable, net||58,634||58,568|
|Other long-term liabilities||463||580|
|Commitments and contingencies|
|Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock.
|Additional paid-in capital||438,163||436,306|
|Total stockholders’ equity||76,588||69,764|
|Total liabilities and stockholders’ equity||$||196,616||$||182,905|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended
|Product royalty revenues||563||1,187||2|
|Cost of sales||5,560||7,264||4,052|
|Selling, general and administrative||26,736||23,759||16,989|
|Income (loss) from operations||5,982||614||(1,272||)|
|Other expense, net||(1||)||(1||)||—|
|Income (loss) before income taxes||$||4,688||$||(695||)||$||(3,833||)|
|Income tax benefit||278||(1||)||—|
|Net income (loss) attributable to common stockholders||$||4,966||$||(696||)||$||(3,833||)|
|Weighted average common stock shares outstanding||97,118,267||92,118,497||71,344,831|
|Basic earnings (loss) per share||$||0.05||$||(0.01||)||$||(0.05||)|
|Weighted average common stock shares outstanding||106,965,762||92,118,497||71,344,831|
|Diluted earnings (loss) per share||$||0.05||$||(0.01||)||$||(0.05||)|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three months ended
|Net income (loss)||$||4,966||$||( 696||)||$||(3,833||)|
|Adjustments to reconcile net loss to net cash flows from operating activities|
|Accretion of debt discount and loan costs||65||67||634|
|Amortization of intangible assets||1,781||1,896||1,289|
|Provision for inventory obsolescence||405||140||149|
|Stock-based compensation expense||1,520||1,438||1,141|
|Changes in assets and liabilities:|
|Prepaid expenses and other assets||1,169||1,106||218|
|Accounts payable and accrued liabilities||6,920||17,432||1,814|
|Net cash flows provided by (used in) operating activities||6,387||16,922||(2,886||)|
|Disposal of property and equipment||—||—||(79||)|
|Net cash flows used in investing activities||—||(10,011||)||(79||)|
|Proceeds from exercise of stock options||338||1,127||472|
|Debt issuance costs||—||(13||)||—|
|Net cash flows provided by financing activities||338||1,114||472|
|Net change in cash and cash equivalents||6,725||8,025||(2,493||)|
|Cash and cash equivalents at beginning of period||63,888||55,863||43,822|
|Cash and cash equivalents at end of period||$||70,613||$||63,888||$||41,329|
RECONCILIATION OF NON-GAAP METRICS
Reconciliations of non-GAAP metrics to most directly comparable
The following tables reconcile net income/(loss)earnings and computations (in thousands) under GAAP to a Non-GAAP basis.
|Three Months Ended
|Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP)||Dec. 31, 2019
|GAAP net income/(loss)||$||4,966||$||(696||)||$||(3,833||)|
|Provision for income taxes||(278||)||1||—|
|Net interest expense||1,294||1,308||2,561|
|Depreciation and amortization||1,802||3,491||1,375|
|Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)|
|GAAP net income/(loss)||4,966||(696||)||(3,833||)|
|Stock-based compensation expense||1,520||1,438||1,142|
|Amortization of intangible assets||1,781||1,899||1,289|
|Amortization of warrant discount||—||—||269|
|Non-recurring financial impact – BUNAVAIL discontinuation||—||3,750||—|
|Non-GAAP net income/(loss)||$||8,267||$||6,391||$||(1,133||)|
Source: BioDelivery Sciences International