GlobeNewswire Inc | Mar 10, 2021 08:00AM EST

March 10, 2021

Total Company Net Revenue Increased 40% versus Prior Year to Reach an All-Time High of $156.5 Million

Record Level Profitability with Net Income of $25.7 Million, Full-Year EBITDA Margin of 26% and Operating Cash Generation of $25 Million

Conference Call and Webcast Scheduled for 8:30 AM EST Today

RALEIGH, N.C., March 10, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc.(NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the fourth quarter and full-year ended December 31, 2020, as well as the following operational and performance highlights.

Key Business Highlights

-- Total Company full-year net revenue of $156.5 million delivered growth of 40% versus 2019 mainly driven by BELBUCA(buprenorphine buccal film) CIII net sales of $136.1 million, an increase of 40% compared to 2019, and Symproic (naldemedine) net sales of $14.7 million in 2020, an increase of 83% over 2019. -- Total Company net revenue for the fourth quarter increased by 33% versus the prior year period to $42.2 million.This growth was driven by BELBUCA netsales of $35.6 million, an increase of 26% versus the prior year period, and Symproic net sales of $3.7 million, an increase of 35% compared to the fourth quarter of 2019. -- BELBUCA reached all-time high prescription volume and market share, with total BELBUCA prescriptions of close to 119,000 during the fourth quarter, representing year-over-year prescription volume growth of 21%. -- Symproic reached all-time high prescription volume and market share, with total Symproic prescriptions of close to 19,000 in the fourth quarter, representing growth of 10% versus the prior year. -- Achieved significant profitability delivering $10.2 million of GAAP Net Income and an attractive 34% EBITDA margin in the fourth quarter of 2020, as well as full year GAAP net income of $25.7 million, or $0.26 per share, and a 26% EBITDA margin. -- The Company initiated share repurchases late in the fourth quarter under the previously announced share buyback program, completing purchases of 48,000 shares in the fourth quarter, and approximately 660,000 additional share purchases in the first quarter through March 8th, for approximately $2.9 million in total. -- Terry Coelho promoted to Executive Vice President and Chief Financial Officer.

The impressive momentum and growth of our innovative products has persisted through the fourth quarter and full year 2020. Our high performing commercial team has been responding effectively to the evolving market conditions during the pandemic, and focused execution during the fourth quarter drove strong prescription trends for both BELBUCA and Symproic, stated Jeff Bailey, CEO of BDSI. Our brands continued to capture market share in 2020 and the Company is poised for continued success as the selling environment improves in 2021.

Fourth Quarter 2020 Financial Results

Total Company Net Revenue for the fourth quarter of 2020 was a record $42.2 million, an increase of 33% compared to $31.6 million in the fourth quarter of 2019, and an increase of 7% compared to $39.4 million in the third quarter of 2020.

BELBUCA Net Sales for the fourth quarter of 2020 were $35.6 million, an increase of 26% compared to $28.3 million in the fourth quarter of 2019, and an increase of 2% compared to $34.8 million in the third quarter of 2020. BELBUCA gross to net deductions increased in the fourth quarter as anticipated, primarily due to typical increases seen for Medicare coverage gap.

Symproic Net Sales for the fourth quarter were $3.7 million, an increase of 35% compared to $2.7 million in the fourth quarter of 2019, and an increase of 6% compared to $3.5 million in the third quarter of 2020.

BUNAVAIL Net Revenue for the fourth quarter was $2.4 million, reflecting the release of a portion of the sales returns reserves taken at the time discontinuation was announced. In June 2020, the Company discontinued marketing of BUNAVAIL.

Total Operating Expenses for the fourth quarter of 2020 were $21.4 million, compared to $23.8 million in the fourth quarter of 2019 and $22.5 million in the third quarter of 2020.

GAAP Net Incomefor the fourth quarter of 2020 was $10.2 million, or $0.10 per share, compared to GAAP net loss of $0.7 million, or $0.01 per share, in the fourth quarter of 2019 and GAAP net income of $9.4 million, or $0.09 per share, in the third quarter of 2020.

EBITDA for the fourth quarter of 2020 was $14.3 million, or 34% of net sales, compared to $4.1 million or 13% of net sales, in the fourth quarter of 2019.

Non-GAAP Net Income for the fourth quarter of 2020 was $13.7 million and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets. This reflects an increase of $7.3 million as compared to non-GAAP net income of $6.4 million in the fourth quarter of 2019, excluding the same items plus the non-recurring financial impact of discontinuation of the marketing of BUNAVAIL.

Full-Year 2020 Financial Results

Total Net Revenue for full-year 2020 was $156.5 million, an increase of 40% compared to $111.4 million for full-year 2019.

BELBUCA Net Sales for full-year 2020 were $136.1 million, an increase of 40% compared to $97.5 million for full-year 2019.

Symproic Net Sales for full-year 2020 were $14.7 million, an increase of 83% compared to 2019. The Company acquired Symproic in April 2019 and generated net sales of $8.1 million during the period from April to December 2019.

BUNAVAIL Net Revenue for full-year 2020 was $3.7 million, compared to $2.3 million for full-year 2019, and includes the release of certain sales returns reserves of $2.4 million following the discontinuation of marketing in June 2020.

Product Royalty Revenue for full-year 2020 was $1.9 million, compared to $3.5 million for full-year 2019.

Total Operating Expenses for full-year 2020 were $98.8 million, compared to $86.1 million for full-year 2019.

GAAP Net Incomefor full-year 2020 was $25.7 million, or $0.26 per share, an increase of $41.0 million compared to GAAP net loss of $15.3 million, or $(0.18) per share, for full-year 2019.

EBITDA for full-year 2020 was $40.5 million, or 26% of net sales, an increase of $28.0 million compared to $12.5 million, or 11% of net sales for full-year 2019.

Non-GAAP Net Income for full-year 2020 was $44.2 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets, one-time expenses related to the CEO transition were incurred in 2020, and the non-recurring financial impact related to the discontinuation of the marketing of BUNAVAIL.

Cash Position As of December 31, 2020, cash and cash equivalents were approximately $111.6 million, compared to $63.9 million as of December 31, 2019. The total cash flow generation over 2020 of $47.7 million includes operating cash generation of $25 million, $3.4 million in proceeds from the exercise of options, and net proceeds of $19.6 million from the draw down in May 2020 of $20 million from our existing debt facility, partially offset by $0.2 million used to repurchase shares in the quarter.

Financial Guidance

The Company expects full year 2021 total net sales of$170 - $180 million, including full year 2021 BELBUCA net sales of$155 - $165 million. These estimates incorporate the expected impact in Q1 2021 from the winter storms in the South-Central region, which affected some of the Companys most productive territories. Total operating expenses are expected to be in the range of $115 - $120 million, as the Company continues to invest to support the growth of its brands, and EBITDA is expected to be in the range of $40 - $50 million in 2021. The Company expects to continue being operating cash flow positive throughout 2021.

Im proud of how the BDSI team really pulled together, and also thrived, during 2020 in what was a challenging year for the industry due to the pandemic. I would like to recognize the efforts and contributions of all BDSI employees. I have great confidence that, with the strength of this team, high-growth brands, and a strong balance sheet, BDSI will continue to drive long-term shareholder value, stated Jeff Bailey.

Conference Call & Webcast Details

BioDelivery Scienceswill host a conference call and webcast today,March 10, 2021, at8:30 a.m. ETto present fourth quarter and full-year 2020 results and to provide a business update. Dial-in details are as follows:

Date: Wednesday, March 10, 2021Time: 8:30 AM Eastern TimeDomestic: 877-407-0789International: 201-689-8562Conference ID: 13715530Webcast: http://public.viavid.com/index.php?id=143193

ABOUTBIODELIVERY 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 products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain and opioid-induced constipation.

CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS

This press release and any statements of employees, representatives, and partners ofBioDelivery 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 BDSIs 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 BDSIs management and are subject to significant risks and uncertainties, including those detailed in BDSIs filings with theSecurities and Exchange Commission. Actual results (including, without limitation, the expectations for total company net sales, BELBUCA net sales, operating expenses, EBITDA and operating cash flows in 2021) 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 BDSIs 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 theUS Securities and Exchange Commissionand 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 the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense, non-cash 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 financial impact of the debt refinancing in 2019, the discontinuation of marketing of BUNAVAIL, and costs associated with the CEO transition in 2020.

EBITDA excludes net interest, including both interest expenses and interest income, provision for (benefit from) income taxes, 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 incomeand 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 incomeand 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.

2021BioDelivery Sciences International, Inc. All rights reserved.

Contact:

Bob YedidLifeSci Advisors646-597-6989Bob@LifeSciAdvisors.com

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIESUNAUDITED CONSOLIDATED BALANCE SHEETS(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

December December 31, 31, 2020 2019ASSETS Current assets: Cash and cash equivalents $ 111,584 $ 63,888 Accounts receivable, net 48,150 38,790 Inventory, net 17,443 11,312 Prepaid expenses and other current assets 5,208 3,769 Total current assets 182,385 117,759 Property and equipment, net 1,418 2,075 Goodwill 2,715 2,715 License and distribution rights, net 53,376 60,309 Other intangible assets, net ? 47 Total assets $ 239,894 $ 182,905 LIABILITIES AND STOCKHOLDERS? EQUITY Current liabilities: Accounts payable and accrued liabilities $ 52,995 $ 53,993 Total current liabilities 52,995 53,993 Notes payable, net 78,452 58,568 Other long-term liabilities 213 580 Total liabilities 131,660 113,141 Commitments and contingencies Stockholders? equity: Preferred Stock, 5,000,000 shares authorized;2,714,300 shares issued; Series ANon-Voting Convertible Preferred Stock. $0.001 parvalue, 0 and 2,093,155 sharesoutstanding at December31, 2020 and December31, ? 2 2019, respectively; Series BNon-Voting Convertible Preferred Stock, $0.001 parvalue, 443 and 618 sharesoutstanding at December31, 2020 and December31,2019 respectively.Common Stock, $.001 par value; 235,000,000 and175,000,000 shares authorized atDecember31, 2020 and December31, 2019 respectively;101,417,441 and 104 96 96,189,074 shares issued; 101,354,447 and 96,173,583shares outstanding atDecember31, 2020 and December31, 2019,respectively.Additional paid-in capital 449,264 436,306 Treasury stock, at cost, 62,994 and 15,491 shares asof December 31, 2020 and (252 ) (47 )December 31, 2019, respectivelyAccumulated deficit (340,882 ) (366,593 )Total stockholders? equity 108,234 69,764 Total liabilities and stockholders? equity $ 239,894 $ 182,905

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIESUNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

Quarter Ended December 31, Year Ended December 31, 2020 2019 2020 2019Revenues: Product sales $ 41,628 $ 30,450 $ 154,574 $ 107,888 Product royalty 539 1,187 1,897 3,341 revenuesContract revenues ? ? ? 160 Total Revenues: 42,167 31,637 156,471 111,389 Cost of sales 8,294 7,265 24,665 21,590 Expenses: Selling, general and 21,418 23,759 98,827 86,063 administrativeTotal Expenses: 21,418 23,759 98,827 86,063 Income from 12,455 613 32,979 3,736 operationsInterest expense, (2,028 ) (1,308 ) (7,013 ) (19,040 )netOther (expense)/ 3 (1 ) (3 ) 4 income, netIncome/(loss) before 10,430 (696 ) 25,963 (15,300 )income taxesIncome tax benefit (233 ) ? (252 ) (5 )Net income/(loss) 10,197 (696 ) 25,711 (15,305 )Net income/(loss)attributable to $ 10,197 $ (696 ) $ 25,711 $ (15,305 )commonstockholdersBasic Weighted averagecommon stock shares 101,178,994 92,118,497 99,830,520 83,213,704 outstandingBasic earnings/ $ 0.10 $ (0.01 ) $ 0.26 $ (0.18 )(loss) per shareDiluted Weighted averagecommon stock shares 105,648,727 92,118,497 105,062,522 83,213,704 outstandingDiluted earnings/ $ 0.10 $ (0.01 ) $ 0.24 $ (0.18 )(loss) per share

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS (U.S. DOLLARS, IN THOUSANDS)

Year Ended December 31, 2020 2019 2018Operating activities: Net income (loss) $ 25,711 $ (15,305 ) $ (33,867 )Adjustments to reconcile net income(loss) to net cash flows used in operating activitiesDepreciation 538 1,846 740 Accretion of debt discount and loan 320 11,508 4,138 costsAmortization of intangible assets 6,981 6,981 5,157 Provision for (recovery from) inventory 1,870 197 (56 )obsolescenceImpairment loss on equipment ? ? 78 Stock-based compensation expense 9,595 5,416 5,941 Deferred income taxes ? ? 40 Changes in assets and liabilities, net of effect of acquisition:Accounts receivable (9,360 ) (25,163 ) (4,640 )Inventories (8,001 ) (6,102 ) 741 Prepaid expenses and other assets (1,439 ) (581 ) 422 Accounts payable and accrued expenses (1,234 ) 32,275 (2,807 )Net cash flows used in operating 24,981 11,072 (24,113 )activitiesInvesting activities: Product acquisitions ? (30,685 ) (1,951 )Acquisitions of equipment (13 ) (79 ) (112 )Net cash flows used in investing (13 ) (30,764 ) (2,063 )activitiesFinancing activities: Proceeds from exercise of stock options 3,369 2,321 670 Proceeds from issuance of common stock,less underwriters fee ? 48,000 ? discountProceeds from issuance of Series B ? ? 50,000 preferred stockPayment on note payable ? (67,346 ) ? Proceeds from notes payable 20,000 59,987 ? Equity finance costs ? (410 ) (1,417 )Payment of deferred financing fees (436 ) ? (450 )Loss on refinancing of former debt ? (2,794 ) ? Payment on share repurchase (205 ) ? ? Net cash flows from financing 22,728 39,758 48,803 activitiesNet change in cash and cash equivalents 47,696 20,066 22,627 Cash and cash equivalents at beginning 63,888 43,822 21,195 of yearCash and cash equivalents at end of $ 111,584 $ 63,888 $ 43,822 year

BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIESUNAUDITED RECONCILIATION OF NON-GAAP METRICS(U.S. DOLLARS, IN THOUSANDS)

Year Ended December 31,Reconciliation of GAAP net income/(loss) to 2020 2019 2018EBITDA (non-GAAP)GAAP net income/(loss) $ 25,711 $ (15,305 ) $ (33,867 ) Add back/(subtract): Income tax provision 252 5 14 Net interest expense 7,013 19,036 10,206 Depreciation and amortization 7,521 8,748 6,188 EBITDA $ 40,497 $ 12,484 $ (17,459 )Reconciliation of GAAP net income/(loss) toNon-GAAP net income/(loss)GAAP net income/(loss) 25,711 (15,305 ) (33,867 ) Non-GAAP adjustments: Stock-based compensation expense 6,107 5,416 5,941 Amortization of intangible assets 6,982 6,981 5,157 Amortization of warrant discount ? 448 1,076 Non-recurring financial impact of debt ? 11,866 ? refinanceNon-recurring financial impact of BUNAVAIL 295 3,750 ? discontinuationNon-recurring financial impact of CEO 5,145 ? ? transitionNon-GAAP net income/(loss) $ 44,240 $ 13,156 $ (21,693 )

Quarter Ended,Reconciliation of GAAP net income/(loss) to December September DecemberEBITDA (non-GAAP) 31, 30, 31, 2020 2020 2019GAAP net income/(loss) $ 10,197 $ 9,383 $ (696 )Add back: Provision for income taxes 233 211 1 Net interest expense 2,022 2,012 1,308 Depreciation and amortization 1,806 1,754 3,491 EBITDA $ 14,258 $ 13,360 $ 4,104 Reconciliation of GAAP net income/(loss) toNon-GAAP net income/(loss)GAAP net income/(loss) 10,197 9,383 (696 )Non-GAAP adjustments: Stock-based compensation expense 1,750 1,473 1,438 Amortization of intangible assets 1,733 1,734 1,899 Non-recurring financial impact of BUNAVAIL ? ? 3,750 discontinuationNon-recurring financial impact of CEO ? 67 ? transitionNon-GAAP net income $ 13,680 $ 12,657 $ 6,391