GlobeNewswire Inc | Nov 3, 2021 08:00AM EDT

November 03, 2021

Total Net Revenue of $41.1 Million, an Increase of 4% versus Prior Year

Strong profitability with GAAP EPS of $0.07, EBITDA Margin of 27% and $7.0 million Operating Cash Flow

Closed acquisition of ELYXYB, the first FDA-approved, ready-to-use oral solution for acute migraine with potential long-term peak sales opportunity of $350 - $400 million

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

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 netsales 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 Incomefor 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. Reddys 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 Companys 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.

Conference Call & Webcast Details

BioDelivery Scienceswill host a conference call and webcast today,November 3, 2021, at8:30 a.m. ETto present third quarter 2021 results and to provide a business update. Dial-in details are as follows:

Date: Wednesday, November 3, 2021Time: 8:30 AM Eastern TimeDomestic: 877-407-0789International: 201-689-8562Conference ID: 13723637Webcast: http://public.viavid.com/index.php?id=146730

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 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.

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 the Securities and Exchange Commission. Actual results including, without limitation, the expectations for: net revenue, BELBUCA net sales, operating expenses, EBITDA and operating cash flows for 2021, the planned launch of ELYXYB, including net sales of ELYXYB and potential expansion opportunities for ELYXYB, 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 COVID-19 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 2020 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 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, and the financial impact of certain one-time items that are non-recurring, including the discontinuation of Bunavail, and costs associated with the CEO transition in Q2 2020.

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 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 SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)(Unaudited)

September 30, December 31, 2021 2020ASSETS Current assets: Cash and cash equivalents $ 100,710 $ 111,584 Accounts receivable, net 57,572 48,150 Inventory, net 23,075 17,443 Prepaid expenses and other current assets 6,904 5,208 Total current assets 188,261 182,385 Property and equipment, net 1,525 1,418 Goodwill 2,715 2,715 License and distribution rights, net 63,569 53,376 Total assets $ 256,070 $ 239,894 LIABILITIES AND STOCKHOLDERS? EQUITY Current liabilities: Accounts payable and accrued liabilities $ 74,580 $ 52,995 Notes payable, current 3,077 ? Total current liabilities 77,657 52,995 Notes payable, less current maturities 55,638 78,452 Other long-term liabilities ? 213 Total liabilities 133,295 131,660 Commitments and contingencies Stockholders? equity: Preferred Stock, 5,000,000 shares authorized;Series B Non-Voting Convertible Preferred Stock,$0.001 par value, 443 shares outstanding at ? ? September30, 2021 and December31, 2020,respectively.Common Stock, $0.001 par value; 235,000,000shares authorized at September30, 2021 andDecember31, 2020, respectively; 102,057,290 and 104 104 101,417,441 shares issued; 98,791,606 and101,354,447 shares outstanding at September30,2021 and December31, 2020, respectively.Additional paid-in capital 454,738 449,264 Treasury stock, at cost, 3,265,684 and 62,994shares, as of September30, 2021 and December 31, (12,155 ) (252 ) 2020, respectively.Accumulated deficit (319,912 ) (340,882 ) Total stockholders? equity 122,775 108,234 Total liabilities and stockholders? equity $ 256,070 $ 239,894

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

Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020Revenues: Product sales $ 41,072 $ 38,785 $ 122,398 $ 112,946 Productroyalty 20 658 1,151 1,358 revenuesTotal 41,092 39,443 123,549 114,304 Revenues:Cost of sales 6,365 5,376 16,470 16,371 Expenses: Selling,general and 25,468 22,461 79,007 77,408 administrativeTotal 25,468 22,461 79,007 77,408 Expenses:Income from 9,259 11,606 28,072 20,525 operationsInterest (1,984 ) (2,010 ) (5,962 ) (4,997 ) expense, netOther(expense)/ ? (2 ) (1 ) 6 income, netIncome before $ 7,275 $ 9,594 $ 22,109 $ 15,534 income taxesIncome tax (606 ) (211 ) (1,139 ) (19 ) provisionNet incomeattributable $ 6,669 $ 9,383 $ 20,970 $ 15,515 to commonstockholdersBasic Weightedaverage common 98,699,857 101,031,317 99,485,399 99,377,748 stock sharesoutstandingBasic earnings $ 0.07 $ 0.09 $ 0.21 $ 0.16 per shareDiluted Weightedaverage common 102,430,883 105,783,568 103,473,967 104,836,493 stock sharesoutstandingDilutedearnings per $ 0.07 $ 0.09 $ 0.20 $ 0.15 share

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

Nine months ended September 30, 2021 2020Operatingactivities: Net income $ 20,970 $ 15,515 Adjustments to reconcile net income to net cash flows from operating activitiesDepreciation and amortization 97 467 Accretion of debt discount and loan costs 264 231 Amortization of intangible assets 5,262 5,248 Provision for/(release of) inventory obsolescence 1,100 (297 ) Stock-based compensation expense 5,024 7,845 Net change in operating lease assets and (30 ) ? liabilitiesChanges in assets and liabilities: Accounts receivable (9,422 ) (5,040 ) Inventories (6,731 ) (7,278 ) Prepaid expenses and other assets (1,856 ) (1,985 ) Accounts payable and accrued liabilities 12,005 (701 ) Taxes payable 606 (40 ) Net cash flows provided by operating activities 27,289 13,965 Investing activities: Product acquisitions (6,456 ) ? Acquisitions of property, plant and equipment (415 ) ? Net cash flows used in investing activities (6,871 ) ? Financing activities: Payment on notes payable (20,000 ) ? Proceeds from notes payable ? 20,000 Proceeds from exercise of stock options 611 2,761 Payment on share repurchase (11,903 ) ? Payment on deferred financing fees ? (437 ) Net cash flows (used in)/provided by financing (31,292 ) 22,324 activitiesNet change in cash and cash equivalents (10,874 ) 36,289 Cash and cash equivalents at beginning of period 111,584 63,888 Cash and cash equivalents at end of period $ 100,710 $ 100,177

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

Three Months Ended Nine Months Ended September 30, September30,Reconciliation ofGAAP net income to 2021 2020 2021 2020EBITDA (non-GAAP)GAAP net income $ 6,669 $ 9,383 $ 20,970 $ 15,515 Add back/ (subtract):Income tax 606 211 1,139 19 provisionNet interest 1,984 2,012 5,962 4,991 expenseDepreciation and 1,837 1,754 5,359 5,715 amortizationEBITDA $ 11,096 $ 13,360 $ 33,430 $ 26,240 Reconciliation ofGAAP net income to Non-GAAP netincomeGAAP net income $ 6,669 $ 9,383 $ 20,970 $ 15,515 Non-GAAP adjustments:Stock-basedcompensation 1,837 1,473 5,024 4,424 expenseAmortization of 1,795 1,734 5,262 5,248 intangible assetsNon-recurringfinancial impact ? 67 ? 5,078 of CEO transitionNon-recurringfinancial impact ? ? ? 295 of BUNAVAILdiscontinuationNon-GAAP net $ 10,301 $ 12,657 $ 31,256 $ 30,560 income