Document

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 5, 2020
 
 
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
 
 
Delaware001-31361 35-2089858
(State or other jurisdiction
of incorporation)
(Commission
File Number)
 
(IRS Employer
Identification No.)
4131 ParkLake Ave., Suite 225 
RaleighNC27612
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: 919-582-9050
Not Applicable
(Former name or former address, if changed since last report)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under any of the following provisions:
 
 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))







Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class 
Trading
Symbol(s)
 
Name of each exchange
on which registered
Common stock, par value $0.001 BDSI The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company  ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 2.02.Results of Operations and Financial Condition.

On August 5, 2020, BioDelivery Sciences International, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2020. A copy of the press release is being furnished as Exhibit 99.1 to this Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
 
Item 9.01.Financial Statements and Exhibits.
 
(i)Exhibits
Exhibit
No.
  Description
99.1    
104  Cover Page Interactive Data File (embedded within the Inline XBRL document contained in Exhibit 104)



SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
August 5, 2020 BIODELIVERY SCIENCES INTERNATIONAL, INC.
 By: /s/ Mary Theresa Coelho
 Name: Mary Theresa Coelho
 Title: Chief Financial Officer and Treasurer


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BioDelivery Sciences Reports Strong Q2 2020 Results
Second Quarter Total Company Net Revenue Increased 23% versus Prior Year to $36.6 Million
Second Quarter BELBUCA® Net Sales Increased 34% versus Prior Year to $32.3 Million
BELBUCA and Symproic® Each Reach All Time High TRx Volume and Market Share
Conference Call and Webcast Scheduled for 8:30 AM EST Today
RALEIGH, N.C., August 5, 2020 - 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 second quarter ended June 30, 2020, as well as the following operational and performance highlights.
Key Business Highlights
Total Company net revenue for the second quarter increased by 23% versus the prior year period to $36.6 million. This growth was driven by BELBUCA net sales of $32.3 million, an increase of 34% versus the prior year period, and Symproic net sales of $3.4 million, an increase of 7% compared to the second quarter of 2019.
Total BELBUCA prescriptions reached an all-time high of 104,687 during the second quarter, representing year-over-year prescription volume growth of 31%.
Total Symproic prescriptions were more than 17,200 in the second quarter, representing growth of 11% versus the prior year.
Appointed Jeffrey A. Bailey as interim Chief Executive Officer (CEO).
Successfully adapted commercial model in response to evolving COVID-19 market conditions, which included a reduction in patient visits to physicians. This was demonstrated by robust brand performance year over year, while also tightly managing expenses to drive positive net income.
“Our business has proven to be extremely resilient during the second quarter as seen with the all-time high TRx volume and market shares achieved for both BELBUCA and Symproic,” stated Jeff Bailey, interim CEO of BDSI. “BDSI is in the best financial position it has ever been from a cash and profitability perspective, and fundamentally the demand for BELBUCA and Symproic is strong, positioning the company well to continue supporting our commercial team with new and enhanced tools adapted for the current environment.”
Second Quarter 2020 Financial Results
Total Company Net Revenue for the second quarter of 2020 was $36.6 million, an increase of 23% compared to $29.7 million in the second quarter of 2019, and a decrease of 4% compared to $38.3 million in the first quarter of 2020.
BELBUCA Net Sales for the second quarter of 2020 were $32.3 million, an increase of 34% compared to $24.1 million in the second quarter of 2019, and a decrease of 3% compared to $33.5 million in the first quarter of 2020.
Symproic Net Sales for the second quarter were $3.4 million, an increase of 7% compared to $3.2 million in the second quarter of 2019, and a decrease of 18% compared to $4.2 million in the first quarter of 2020.
BUNAVAIL Net Sales for the second quarter were $0.7 million, compared to $0.8 million in the second quarter of 2019. In March of this year, the Company announced the planned discontinuation of marketing of BUNAVAIL and ceased shipping product on June 15, 2020.


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Total Operating Expenses for the second quarter of 2020 were $28.2 million, compared to $26.7 million in the first quarter of 2020 and $22.0 million in the second quarter of 2019. Second quarter costs declined $3.6 million compared to the first quarter of 2020, excluding the $5.1 million of non-recurring costs related to the CEO transition.
GAAP Net Income for the second quarter of 2020 was $1.2 million, or $0.01 per share, compared to GAAP net income of $5.0 million, or $0.05 per share, for the first quarter of 2020 and GAAP net loss of $11.1 million, or ($0.13) per share, in the second quarter of 2019.
EBITDA for the second quarter of 2020 was $5.1 million, or 14% of net sales, compared to $7.8 million in the first quarter of 2020 and $4.8 million in the second quarter of 2019.
Non-GAAP Net Income for the second quarter of 2020 was $9.6 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets, non-recurring financial impact of the BUNAVAIL discontinuation and the non-recurring financial impact of the CEO transition.
Cash Position: As of June 30, 2020, cash and cash equivalents were approximately $91.0 million, compared to $63.9 million at December 31, 2019, reflecting the generation of $5.0 million of positive operating cash flow and $2.5 million in proceeds from the exercise of options, together with $19.6 million of net proceeds from increasing our existing credit facility.
“A very important objective through this COVID-19 pandemic has been on the health and safety of our employees and the communities we serve,” stated Jeff Bailey. “Lastly, I’d like to thank the entire BDSI team for their commitment and continued focus on meeting patient needs.”
Conference Call & Webcast Details
BioDelivery Sciences will host a conference call and webcast today, August 5, 2020, at 8:30 a.m. ET to present second quarter 2020 results and to provide a business update.  Dial-in details are as follows:
Date: Wednesday, August 5, 2020
Time:8:30 AM Eastern Time
Domestic:866-248-8441
International:720-452-9102
Conference ID:9339657
Webcast:http://public.viavid.com/index.php?id=141000
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 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 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


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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 and Symproic 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 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, amortization of intangible assets, amortization of certain warrant discount costs in second quarter 2019, and the financial impact of certain one-time items that are non-recurring, including the financial impact of the debt refinancing in second quarter 2019, the discontinuation of marketing of BUNAVAIL, and costs associated with the CEO transition.
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 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.
Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com


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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
(Unaudited)
June 30,
2020
December 31,
2019
ASSETS
Current assets:
Cash and cash equivalents$91,009 $63,888 
Accounts receivable, net48,126 38,790 
Inventory, net17,774 11,312 
Prepaid expenses and other current assets2,099 3,769 
Total current assets159,008 117,759 
Property and equipment, net1,508 2,075 
Goodwill2,715 2,715 
License and distribution rights, net56,842 60,309 
Other intangible assets, net— 47 
Total assets$220,073 $182,905 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities$56,646 $53,993 
Total current liabilities56,646 53,993 
Notes payable, net78,274 58,568 
Other long-term liabilities383 580 
Total liabilities135,303 113,141 
Commitments and contingencies
Stockholders’ equity:
Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 0 and 2,093,155 shares outstanding at June 30, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at June 30, 2020 and December 31, 2019, respectively.— 
Common Stock, $0.001 par value; 175,000,000 shares authorized at June 30, 2020 and December 31, 2019, respectively; 100,916,511 and 96,189,074 shares issued; 100,901,020 and 96,173,583 shares outstanding at June 30, 2020 and December 31, 2019, respectively.99 96 
Additional paid-in capital445,180 436,306 
Treasury stock, at cost,15,491 shares, as of June 30, 2020 and December 31, 2019.(47)(47)
Accumulated deficit(360,462)(366,593)
Total stockholders’ equity84,770 69,764 
Total liabilities and stockholders’ equity$220,073 $182,905 





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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
(Unaudited)
Three months ended June 30,Six months ended June 30,
2020201920202019
Revenues:
Product sales$36,445 $28,056 $74,161 $47,815 
Product royalty revenues137 1,461 700 1,471 
Contract revenues— 160 — 160 
Total Revenues:36,582 29,677 74,861 49,446 
Cost of sales5,435 4,923 10,995 8,975 
Expenses:
Selling, general and administrative28,211 21,955 54,948 38,944 
Total Expenses:28,211 21,955 54,948 38,944 
Income/(loss) from operations2,936 2,799 8,918 1,527 
Interest expense, net(1,693)(13,937)(2,987)(16,498)
Other income, net
Income/(loss) before income taxes$1,251 $(11,130)$5,939 $(14,963)
Income tax recovery/(provision)(86)— 192 — 
Net income/(loss) attributable to common stockholders$1,165 $(11,130)$6,131 $(14,963)
Basic
Weighted average common stock shares outstanding100,136,893 83,821,811 98,541,877 77,571,003 
Basic earnings/(loss) per share$0.01 $(0.13)$0.06 $(0.19)
Diluted
Weighted average common stock shares outstanding108,111,201 83,821,811 107,062,161 77,571,003 
Diluted earnings/(loss) per share$0.01 $(0.13)$0.06 $(0.19)














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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. DOLLARS, IN THOUSANDS)
(Unaudited)
Six months ended June 30
20202019
Operating activities:
Net income/(loss)$6,131 $(14,963)
Adjustments to reconcile net income/(loss) to net cash flows from operating activities
Depreciation and amortization446 168 
Accretion of debt discount and loan costs142 11,374 
Amortization of intangible assets3,515 3,187 
Provision for inventory obsolescence72 149 
Stock-based compensation expense6,306 2,711 
Changes in assets and liabilities:
Accounts receivable(9,336)(11,252)
Inventories(6,534)(4,716)
Prepaid expenses and other assets1,670 (110)
Accounts payable and accrued liabilities2,617 9,078 
Taxes payable(40)— 
Net cash flows provided by/(used in) operating activities4,989 (4,374)
Investing activities:
Product acquisitions— (20,674)
Acquisitions of equipment— (79)
Net cash flows used in investing activities— (20,753)
Financing activities:
Proceeds from issuance of common stock— 48,000 
Equity issuance costs— (410)
Proceeds from notes payable20,000 60,000 
Proceeds from exercise of stock options2,569 1,070 
Payment on note payable— (67,346)
Loss on refinancing of former debt— (2,794)
Payment on deferred financing fees(437)— 
Net cash flows provided by financing activities22,132 38,520 
Net change in cash and cash equivalents27,121 13,393 
Cash and cash equivalents at beginning of period63,888 43,822 
Cash and cash equivalents at end of period$91,009 $57,215 







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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP METRICS
(U.S. DOLLARS, IN THOUSANDS)
(Unaudited)
Three Months Ended
June 30,
Three Months Ended March 31,
Six Months Ended
June 30,
Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP)20202019202020202019
GAAP net income/(loss)$1,165 $(11,130)$4,966 $6,131 $(14,963)
Add back/(subtract):
Income tax recovery/(provision)86 — (278)(192)— 
Net interest expense1,685 13,929 1,2942,97916,490 
Depreciation and amortization2,159 1,981 1,8023,9603,356 
EBITDA$5,095 $4,780 $7,784 $12,878 $4,883 
Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)
GAAP net income/(loss)$1,165$(11,130)$4,966 $6,131$(14,963)
Non-GAAP adjustments:
Stock-based compensation expense1,364 1,569 1,5206,3052,712 
Amortization of intangible assets1,734 1,898 1,781933,187 
Amortization of warrant discount— 179 — 448 
Non-recurring financial impact of debt refinance— 11,866 — 11,866 
Non-recurring financial impact of CEO transition5,078 — — 5,078— 
Non-recurring financial impact of BUNAVAIL discontinuation295 — — 295— 
Non-GAAP net income/(loss)$9,636 $4,382 $8,267 $17,902 $3,250