UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~September 30, 2019~~March 31, 2020


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number 001-31361

BioDelivery Sciences International, Inc.

(Exact name of registrant as specified in its charter)


Delaware			35-2089858
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

4131 ParkLake Ave., Suite 225, Raleigh, NC			27612
(Address of principal executive offices)			(Zip Code)

Registrant’s telephone number (including area code): 919-582-9050

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, a smaller reporting company or an emerging growth company. See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company”, or “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

Large Accelerated Filer

☐

Accelerated Filer

☒

Non-Accelerated Filer

☐

Smaller Reporting Company

☐

Emerging Growth Company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not 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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of ~~November 12, 2019,~~May 7, 2020, there were ~~89,928,219~~99,904,302 shares of company Common Stock issued and ~~89,912,728~~99,888,811 shares of company Common Stock outstanding.

Table of contents

BioDelivery Sciences International, Inc. and Subsidiaries

Quarterly Report on Form 10-Q

TABLE OF CONTENTS


		Page
Part I. Financial Information
Item 1.	Financial Statements (unaudited)
	Condensed Consolidated Balance Sheets as of ~~September~~March ~~30, 2019~~3 1 , 20 20 and December 31, ~~2018~~2019	1
	Condensed Consolidated Statements of Operations for the three ~~and~~ ~~nine~~months ended ~~September~~March ~~30, 2019~~3 1 , 20 20 and ~~2018~~2019	2
	Condensed Consolidated Statements of Stockholders’ Equity for the three ~~and~~ ~~nine~~months ended ~~September~~March ~~30, 2019~~3 1 , 20 20 and ~~2018~~2019	3
	Condensed Consolidated Statements of Cash Flows for the ~~nine~~three months ended ~~September~~March ~~30, 2019~~3 1 , 20 20 and ~~2018~~2019	54
	Notes to Condensed Consolidated Financial Statements	65
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2719
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	2925
Item 4.	Controls and Procedures	2925
Cautionary Note on Forward -Looking Statements			3025
Part II. Other Information			3026
Item 1.	Legal Proceedings	3026
Item 1A.	Risk Factors	3026
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	3227
Item 3.	Defaults upon Senior Securities	3227
Item 4.	Mine Safety Disclosures	3227
Item 5.	Other Information	3227
Item 6.	Exhibits	3327
Signatures			S-1

Certifications

We own various trademark registrations and applications, and unregistered trademarks, including BioDelivery Sciences International, Inc., BEMA, BELBUCA, BUNAVAIL, ONSOLIS and our corporate logo. We have an exclusive license to use and display the Symproic registered trademark in order to commercialize Symproic in the United States. All other trade names, trademarks and service marks of other companies appearing in this prospectus are the property of their respective holders. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

From time to time, we may use our website, our Facebook page at Facebook.com/BioDeliverySI, ~~and~~ on Twitter at @BioDeliverySI and on LinkedIn at linkedin.com/company/biodeliverysciencesinternational to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.bdsi.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website, our Facebook page and our Twitter posts are not incorporated into, and does not form a part of, this Quarterly Report.

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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)


		September 30, 2019		December 31, 2018			March 31, 2020		December 31, 2019
ASSETS	ASSETS					ASSETS
Current assets:	Current assets:					Current assets:
Cash and cash equivalents	Cash and cash equivalents	$	55,863	$	43,822	Cash and cash equivalents	$	70,613	$	63,888
Accounts receivable, net	Accounts receivable, net	33,422		13,627		Accounts receivable, net	45,114		38,790
Inventory, net	Inventory, net	10,766		5,406		Inventory, net	15,003		11,312
Prepaid expenses and other current assets	Prepaid expenses and other current assets	4,874		3,188		Prepaid expenses and other current assets	2,600		3,769
Total current assets	Total current assets	104,925		66,043		Total current assets	133,330		117,759
Property and equipment, net	Property and equipment, net	3,713		3,072		Property and equipment, net	1,995		2,075
Goodwill	Goodwill	2,715		2,715		Goodwill	2,715		2,715
License and distribution rights, net	License and distribution rights, net	62,044		36,000		License and distribution rights, net	58,576		60,309
Other intangible assets, net	Other intangible assets, net	211		703		Other intangible assets, net	—		47
Total assets	Total assets	$	173,608	$	108,533	Total assets	$	196,616	$	182,905
LIABILITIES AND STOCKHOLDERS’ EQUITY	LIABILITIES AND STOCKHOLDERS’ EQUITY					LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:	Current liabilities:					Current liabilities:
Accounts payable and accrued liabilities	Accounts payable and accrued liabilities	$	46,545	$	21,539	Accounts payable and accrued liabilities	$	60,931	$	53,993
Total current liabilities	Total current liabilities	46,545		21,539		Total current liabilities	60,931		53,993
Notes payable, net	Notes payable, net	58,515		51,652		Notes payable, net	58,634		58,568
Other long-term liabilities	Other long-term liabilities	654		5,600		Other long-term liabilities	463		580
Total liabilities	Total liabilities	105,714		78,791		Total liabilities	120,028		113,141
Commitments and contingencies (Note 11)	Commitments and contingencies (Note 11)					Commitments and contingencies (Note 11)
Stockholders’ equity:	Stockholders’ equity:					Stockholders’ equity:
Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock. $.001 par value, 2,093,155 shares outstanding at both September 30, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value, 1,698 and 3,100 shares outstanding at September 30, 2019 and December 31, 2018, respectively.		2		2
Common Stock, $.001 par value; 175,000,000 shares authorized at September 30, 2019 and 125,000,000 shares authorized at December 31, 2018, respectively; 89,796,774 and 70,793,725 shares issued;89,781,283 and 70,778,234 shares outstanding at September 30, 2019 and December 31, 2018, respectively.		90		71
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 March 31, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at March 31, 2020 and December 31, 2019, respectively.						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 March 31, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at March 31, 2020 and December 31, 2019, respectively.	—		2
Common Stock, $0.001 par value; 175,000,000 shares authorized at March 31, 2020 and December 31, 2019, respectively; 99,821,408 and 96,189,074 shares issued; 99,805,917 and 96,173,583 shares outstanding at March 31, 2020 and December 31, 2019, respectively.						Common Stock, $0.001 par value; 175,000,000 shares authorized at March 31, 2020 and December 31, 2019, respectively; 99,821,408 and 96,189,074 shares issued; 99,805,917 and 96,173,583 shares outstanding at March 31, 2020 and December 31, 2019, respectively.	99		96
Additional paid-in capital	Additional paid-in capital	433,746		381,004		Additional paid-in capital	438,163		436,306
Treasury stock, at cost, 15,491 shares		(47)		(47)
Treasury stock, at cost,15,491 shares, as of March 31, 2020 and December 31, 2019.						Treasury stock, at cost,15,491 shares, as of March 31, 2020 and December 31, 2019.	(47)		(47)
Accumulated deficit	Accumulated deficit	(365,897)		(351,288)		Accumulated deficit	(361,627)		(366,593)
Total stockholders’ equity	Total stockholders’ equity	67,894		29,742		Total stockholders’ equity	76,588		69,764
Total liabilities and stockholders’ equity	Total liabilities and stockholders’ equity	$	173,608	$	108,533	Total liabilities and stockholders’ equity	$	196,616	$	182,905

See notes to condensed consolidated financial statements

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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 September 30, Nine months ended September 30,
2019 2018 2019 2018
Revenues:
Product sales $ 29,623 $ 13,763 $ 77,438 $ 34,367
Product royalty revenues 683 370 2,154 2,197
Contract revenues — 23 160 1,047
Total Revenues: 30,306 14,156 79,752 37,611
Cost of sales 5,350 3,779 14,325 11,760
Expenses:
Research and development — 699 — 4,038
Selling, general and administrative 23,360 13,489 62,304 41,013
Total Expenses: 23,360 14,188 62,304 45,051
Income (loss) from operations 1,596 (3,811) 3,123 (19,200)
Interest expense (1,234) (2,567) (17,732) (7,598)
Other (expense) income, net (3) (2) 5 (8)
Income (loss) before income taxes $ 359 $ (6,380) $ (14,604) $ (26,806)
Income tax expense (5) — (5) (53)
Net income (loss) $ 354 $ (6,380) $ (14,609) $ (26,859)
Beneficial conversion feature of convertible preferred stock — (12,500) — (12,500)
Net income (loss) attributable to common stockholders $ 354 $ (18,880) $ (14,609) $ (39,359)
Basic
Weighted average common stock shares outstanding 89,649,922 64,900,007 81,612,112 60,599,456
Basic earnings (loss) per share $ — $ (0.29) $ (0.18) $ (0.65)
Diluted
Weighted average common stock shares outstanding 105,138,894 64,900,007 81,612,112 60,599,456
Diluted earnings (loss) per share $ — $ (0.29) $ (0.18) $ (0.65)


	Three months ended March 31,
	2020		2019
Revenues:
Product sales	$	37,715	$	19,759
Product royalty revenues	563		2
Contract revenues	—		8
Total Revenues:	38,278		19,769
Cost of sales	5,560		4,052
Expenses:
Selling, general and administrative	26,736		16,989
Total Expenses:	26,736		16,989
Income (loss) from operations	5,982		(1,272)
Interest expense	(1,293)		(2,561)
Other expense, net	(1)		—
Income (loss) before income taxes	$	4,688	$	(3,833)
Income tax benefit	278		—
Net income (loss) attributable to common stockholders	$	4,966	$	(3,833)
Basic
Weighted average common stock shares outstanding	97,118,267		71,344,831
Basic earnings (loss) per share	$	0.05	$	(0.05)
Diluted
Weighted average common stock shares outstanding	106,965,762		71,344,831
Diluted earnings (loss) per share	$	0.05	$	(0.05)

See notes to condensed consolidated financial statements

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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)

(Unaudited)

Preferred Stock
Series A Preferred Stock
Series B Common Stock Additional
Paid-In
Capital Treasury
Stock Accumulated
Deficit Total
Stockholders’
Equity
Shares Amount Shares Amount Shares Amount
Balances, June 30, 2018 2,093,155 $ 2 5,000 $ — 59,459,446 $ 59 $ 366,123 $ (47) $ (325,400) $ 40,737
Stock-based compensation — — — — — — 892 — — 892
Stock option exercises — — — — 116,387 — 222 — — 222
Restricted stock awards — — — — 467,298 1 (1) — — —
Series B issuance, net of issuance cost — — — — — — 99 — — 99
Series B conversion to common stock — — (1,900) — 10,555,556 11 (11) — — —
Series B beneficial conversion feature — — — — — — 12,500 — (12,500) —
Net loss — — — — — — — — (6,380) (6,380)
Balances, September 30, 2018 2,093,155 $ 2 3,100 $ — 70,598,687 $ 71 $ 379,824 $ (47) $ (344,280) $ 35,570


	Preferred Stock Series A				Preferred Stock Series B					Common Stock						Additional Paid-In Capital		Treasury Stock	Accumulated Deficit	Total Stockholders’ Equity
	Shares	Amount		Shares	Amount		Shares	Amount
Balances, January 1, 2020	2,093,155	$	2	618	$	—	96,189,074	$	96	$	436,306	$	(47)	$	(366,593)	$	69,764
Stock-based compensation	—	—		—	—		—	—		1,520		—		—		1,520
Stock option exercises	—	—		—	—		107,287	—		338		—		—		338
Restricted stock awards	—	—		—	—		459,670	—		—		—		—		—
Series A conversion to common stock	(2,093,155)	(2)		—	—		2,093,155	2		(1)		—		—		(1)
Series B conversion to common stock	—	—		(175)	—		972,222	1		—		—		—		1
Net loss	—	—		—	—		—	—		—		—		4,966		4,966
Balances, March 31, 2020	—	$	—	443	$	—	99,821,408	$	99	$	438,163	$	(47)	$	(361,627)	$	76,588

~~Table of contents~~

Preferred Stock
Series A Preferred Stock
Series B Common Stock Additional
Paid-In
Capital Treasury
Stock Accumulated
Deficit Total
Stockholders’
Equity
Shares Amount Shares Amount Shares Amount
Balances, January 1, 2019 2,093,155 $ 2 3,100 $ — 70,793,725 $ 71 $ 381,004 $ (47) $ (351,288) $ 29,742
Stock-based compensation — — — — — — 3,978 — — 3,978
Stock option exercises — — — — 412,500 — 1,193 — — 1,193
Restricted stock awards — — — — 801,661 1 (1) — — —
Series B conversion to common stock — — (1,402) — 7,788,888 8 (8) — — —
Equity offering, net of finance costs — — — — 10,000,000 10 47,580 — — 47,590
Net loss — — — — — — — — (14,609) (14,609)
Balances, September 30, 2019 2,093,155 $ 2 1,698 $ — 89,796,774 $ 90 $ 433,746 $ (47) $ (365,897) $ 67,894

Preferred Stock
Series A Preferred Stock
Series B Common Stock Additional
Paid-In
Capital Treasury
Stock Accumulated
Deficit Total
Stockholders’
Equity
Shares Amount Shares Amount Shares Amount
Balances, January 1, 2018 2,093,155 $ 2 — $ — 55,904,072 $ 56 $ 313,922 $ (47) $ (305,056) $ 8,877
Stock-based compensation — — — — — — 4,896 — — 4,896
Stock option exercises — — — — 285,403 — 528 — — 528
Restricted stock awards — — — — 1,733,731 2 (2) — — —
Common stock issuance upon retirement — — — — 2,119,925 2 (2) — — —
Series B issuance, net of issuance costs — — 5,000 — — — 47,993 — — 47,993
Series B conversion to Common Stock — — (1,900) — 10,555,556 11 (11) — — —
Series B beneficial conversion feature — — — — — — 12,500 — (12,500) —
Cumulative effect of accounting change — — — — — — — — 135 135
Net loss — — — — — — — — (26,859) (26,859)
Balances, September 30, 2018 2,093,155 $ 2 3,100 $ — 70,598,687 $ 71 $ 379,824 $ (47) $ (344,280) $ 35,570


	Preferred Stock Series A				Preferred Stock Series B					Common Stock						Additional Paid-In Capital		Treasury Stock	Accumulated Deficit	Total Stockholders’ Equity
	Shares	Amount		Shares	Amount		Shares	Amount
Balances, January 1, 2019	2,093,155	$	2	3,100	$	—	70,793,725	$	71	$	381,004	$	(47)	$	(351,288)	$	29,742
Stock-based compensation	—	—		—	—		—	—		1,141		—		—		1,141
Stock option exercises	—	—		—	—		150,275	—		472		—		—		472
Restricted stock awards	—	—		—	—		500,366	(1)		1		—		—		—
Series B conversion to Common Stock	—	—		(700)	—		3,888,888	4		(4)		—		—		—
Net loss	—	—		—	—		—	—		—		—		(3,833)		(3,833)
Balances, March 31, 2019	2,093,155	$	2	2,400	$	—	75,333,254	$	74	$	382,614	$	(47)	$	(355,121)	$	27,522

See notes to condensed consolidated financial statements

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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(U.S. DOLLARS, IN THOUSANDS)

(Unaudited)


		Nine months ended September 30,							Three months ended March 31,
		2019		2018			2020		2019
Operating activities:	Operating activities:					Operating activities:
Net loss		$	(14,609)	$	(26,859)
Net income (loss)						Net income (loss)	$	4,966	$	(3,833)
Adjustments to reconcile net loss to net cash flows from operating activities	Adjustments to reconcile net loss to net cash flows from operating activities					Adjustments to reconcile net loss to net cash flows from operating activities
Depreciation and amortization		253		685
Impairment loss on equipment		—		78
Depreciation						Depreciation	21		85
Accretion of debt discount and loan costs	Accretion of debt discount and loan costs	11,441		2,953		Accretion of debt discount and loan costs	65		634
Amortization of intangible assets	Amortization of intangible assets	5,084		3,868		Amortization of intangible assets	1,781		1,289
Provision for inventory obsolescence	Provision for inventory obsolescence	57		396		Provision for inventory obsolescence	405		149
Stock-based compensation expense	Stock-based compensation expense	3,978		4,896		Stock-based compensation expense	1,520		1,141
Changes in assets and liabilities, net of effect of acquisition:
Changes in assets and liabilities:						Changes in assets and liabilities:
Accounts receivable	Accounts receivable	(19,795)		(3,581)		Accounts receivable	(6,324)		(2,381)
Inventories	Inventories	(5,416)		261		Inventories	(4,096)		(2,002)
Prepaid expenses and other assets	Prepaid expenses and other assets	(1,686)		(545)		Prepaid expenses and other assets	1,169		218
Accounts payable and accrued liabilities	Accounts payable and accrued liabilities	14,844		(427)		Accounts payable and accrued liabilities	6,920		1,814
Net cash flows used in operating activities		(5,849)		(18,275)
Taxes payable						Taxes payable	(40)		—
Net cash flows provided by (used in) operating activities						Net cash flows provided by (used in) operating activities	6,387		(2,886)
Investing activities:	Investing activities:					Investing activities:
Product acquisitions		(20,674)		(1,951)
Acquisitions of equipment		(79)		(155)
Disposal of property and equipment						Disposal of property and equipment	—		(79)
Net cash flows used in investing activities	Net cash flows used in investing activities	(20,753)		(2,106)		Net cash flows used in investing activities	—		(79)
Financing activities:	Financing activities:					Financing activities:
Proceeds from issuance of common stock		48,000		—
Proceeds from issuance of Series B preferred stock		—		50,000
Equity issuance costs		(410)		(1,410)
Proceeds from notes payable		60,000		—
Proceeds from exercise of stock options	Proceeds from exercise of stock options	1,193		528		Proceeds from exercise of stock options	338		472
Payment on note payable		(67,346)		—
Loss on refinancing of former debt		(2,794)		—
Payment of deferred financing fees		—		(450)
Net cash flows provided by financing activities	Net cash flows provided by financing activities	38,643		48,668		Net cash flows provided by financing activities	338		472
Net change in cash and cash equivalents	Net change in cash and cash equivalents	12,041		28,287		Net change in cash and cash equivalents	6,725		(2,493)
Cash and cash equivalents at beginning of period	Cash and cash equivalents at beginning of period	43,822		21,195		Cash and cash equivalents at beginning of period	63,888		43,822
Cash and cash equivalents at end of period	Cash and cash equivalents at end of period	$	55,863	$	49,482	Cash and cash equivalents at end of period	$	70,613	$	41,329
Cash paid for interest	Cash paid for interest	$	5,339	$	4,645	Cash paid for interest	$	1,442	$	1,931

See notes to condensed consolidated financial statements

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BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

(Unaudited)

1. Organization, basis of presentation and summary of significant policies:

Overview

BioDelivery Sciences International, Inc., together with its subsidiaries (collectively, the “Company”) is a rapidly growing ~~commercial-stage~~ specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions. The Company ishas built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive ~~(BEMA)~~("BEMA"), drug-delivery technology ~~and other drug delivery technologies~~ to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. The Company commercializes in the ~~United States~~U.S. using its own sales force while working in partnership with third parties to commercialize its products outside the ~~United States.~~

In April 2019, the Company entered into an exclusive license agreement for the commercialization of Symproic (naldemedine tosylate) in the United States including Puerto Rico for opioid-induced constipation in adult patients with chronic non-cancer pain (Note 6).U.S.

The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at December 31, ~~2018~~2019 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K for the year ended December 31, ~~2018.~~2019. Certain footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the Securities and Exchange Commission rules and regulations. It is recommended that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, ~~2018.~~2019.

Operating results for the ~~three- and nine-month periods~~three month period ended ~~September 30, 2019~~March 31, 2020 are not necessarily indicative of results for the full year or any other future periods.

As used herein, the Company’s common stock, par value $0.001 per share, is referred to as the “Common Stock” and the Company’s preferred stock, par value $0.001 per share, is referred to as the “Preferred Stock”.

Principles of consolidation

The condensed consolidated financial statements include the accounts of the Company, Arius Pharmaceuticals, Inc. (“Arius”), and Arius Two, Inc. (“Arius Two”) ~~and Bioral Nutrient Delivery, LLC (“BND”)~~. ~~For each period presented, BND has been an inactive subsidiary.~~ All significant inter-company balances and transactions have been eliminated.

Use of estimates in financial statements

The preparation of the accompanying condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the condensed consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates made by the Company include: revenue recognition associated with sales allowances such as returns of product sold, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks; sales bonuses; stock-based compensation; ~~determination of fair values of assets and liabilities relating to business combinations;~~ and deferred income taxes.

Cash and cash equivalents

Cash and cash equivalents consist of operating and money market accounts. Cash equivalents are carried at cost which approximates fair value due to their short-term nature. The Company considers all highly-liquid investments with an original maturity of 90 days or less to be cash equivalents.

~~Table ofContents~~

~~BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES~~

~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~

~~(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)~~

~~(Unaudited)~~

The Company maintains cash equivalent balances with financial institutions that management believes are of high credit quality. The Company’s cash and cash equivalents accounts at times may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk from cash and cash equivalents.

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(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

(Unaudited)

Inventory

Inventories are stated at the lower of cost or net realizable value with costs determined for each batch under the first-in, first-out method and specifically allocated to remaining inventory. Inventory consists of raw materials, work in process and finished goods. Raw materials include amounts of active pharmaceutical ingredient for a product to be manufactured, work in process includes the bulk inventory of laminate (the Company’s drug delivery film) prior to being packaged for sale, and finished goods include pharmaceutical products ready for commercial sale.

On a quarterly basis, the Company analyzes its inventory levels and records allowances for inventory that has become obsolete, inventory that has a cost basis in excess of the expected net realizable value and inventory that is in excess of expected demand based upon projected product sales. ~~The Company reserved $0.2 million for inventory~~Inventory obsolescence ~~as of both September 30, 2019~~reserves at March 31, 2020 and December 31, ~~2018.~~2019 were $0.8 million and $0.4 million, respectively.

Revenue recognition

The main types of revenue contracts are:

•Product sales-Product sales amounts relate to sales of BELBUCA, Symproic and BUNAVAIL. ~~These~~In March 2020 the Company announced it will discontinue marketing of BUNAVAIL in 2020. The Company recognizes revenue on product sales ~~are recognized as revenue~~ when control of the promised goods is transferred to ~~the wholesaler~~its customers in an amount that reflects the consideration expected to be ~~received.~~received in exchange for transferring those goods. The Company accounts for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. When determining whether the customer has obtained control of the goods, the Company considers any future performance obligations. Generally, there is no post-shipment obligation on product sold.

•Product royalty revenues-Product royalty revenue amounts are based on sales revenue of the PAINKYL product under the Company’s license agreement with TTY and the BREAKYL product under the Company’s license agreement with Meda AB, which was acquired by Mylan N.V. (which we refer to herein as Mylan). Product royalty revenues are recognized when control of the product is transferred to the license partner in an amount that reflects the consideration expected to be received. Supplemental sales-based product royalty revenue may also be earned upon the subsequent sale of the product at agreed upon contractual rates.

•Contract revenue-Contract revenue amounts are related to milestone payments under the Company’s license agreements with its partners.

The Company recognizes revenue on product sales when control of the promised goods is transferred to its customers in an amount that reflects the consideration expected to be received in exchange for transferring those goods. The Company accounts for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. When determining whether the customer has obtained control of the goods, the Company considers any future performance obligations. Generally, there is no post-shipment obligation on product sold.

Performance obligations

A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The majority of the Company’s product sales contracts have a single performance obligation as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and, therefore, not distinct. The Company’s performance obligations are satisfied at a point in time. The multiple performance obligations are not allocated based off of the obligations but based off of standard selling price.

Transaction price, including variable consideration

Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, government chargebacks, discounts and rebates, and other incentives, such as voucher programs, and other fee for service amounts that are detailed within contracts between the Company and its customers relating to the Company’s sale of its products.

The Company establishes allowances for estimated rebates, chargebacks and product returns based on numerous qualitative and quantitative factors, including:

•the number of and specific contractual terms of agreements with customers;

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(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

(Unaudited)

~~Adjustments to product sales~~

The Company recognizes product sales net of estimated allowances for rebates, price adjustments, returns, chargebacks, vouchers and prompt payment discounts. A significant majority of the Company’s adjustments to gross product revenues are the result of accruals for its commercial contracts, retail consumer subsidy programs, and Medicaid and Medicare rebates.

~~The Company establishes allowances for estimated rebates, chargebacks and product returns based on numerous qualitative and quantitative factors, including:~~

•~~the number of and specific contractual terms of agreements with customers;~~

•estimated levels of inventory in the distribution channel;

•historical rebates, chargebacks and returns of products;

•direct communication with customers;

•anticipated introduction of competitive products or generics;

•anticipated pricing strategy changes by the Company and/or its competitors;

•analysis of prescription data gathered by a third-party prescription data provider;

•the impact of changes in state and federal regulations; and

•the estimated remaining shelf life of products.

~~The Company uses prescription data purchased~~Revenue from ~~a third-party data provider to develop estimates of historical inventory channel sell-through. The Company utilizes an internal analysis to compare historical net~~ product ~~shipments to estimated historical prescriptions written. Based on that analysis, management develops an estimate~~sales is recorded after considering the impact of the quantity of product in the channel which may be subject to various rebate, chargeback and product return exposures. To estimate months of ending inventory in the Company’s distribution channel, the Company divides estimated ending inventory in the distribution channel by the Company’s recent prescription data, not considering any future anticipated demand growth beyond the succeeding quarter. Monthly for each product line, the Company prepares an internal estimate of ending inventory units in the distribution channel by adding estimated inventory in the channelfollowing variable consideration amounts at the ~~beginning~~time of the period, plus net product shipments for the period, less estimated prescriptions written for the period. This is done for each product line by applying a rate of historical activity for rebates, chargebacks and product returns, adjusted for relevant quantitative and qualitative factors discussed above, to the potential exposed product estimated to be in the distribution channel. In addition, the Company receives daily information from the wholesalers regarding their sales and actual on hand inventory levels of the Company’s products. This enables the Company to execute accurate provisioning procedures.revenue recognition:

Product returns-Consistent with industry practice, the Company offers contractual return rights that allow its customers to return the products within an 18-month period that begins six months prior to and ends twelve months after expiration of the products.

~~Rebates-~~Government rebates and chargebacks- Government rebates and chargebacks include mandated discounts under Medicaid, Medicare, U.S Department of Veterans Affairs and other government agencies ("Government Payors"). The Company estimates the rebates and chargebacks to Government Payors based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates and chargebacks that it will provide to Government Payors based upon (i) the government-mandated discounts applicable to government-funded programs, (ii) information obtained from its customers and (iii) information obtained from other third parties regarding the payor mix for its products. The Company’s liability for ~~government program~~these rebates ~~is calculated based on historical~~consists of estimates of claims for the current quarter and ~~current rebate redemption and utilization rates contractually submitted by~~estimated future claims that will be made for product shipments that have been recognized as revenue, but remain in the distribution channel inventories at the end of each ~~program’s administrator.~~reporting period.

~~Price adjustments and chargebacks-~~Commercial Contracts-The Company’s estimates of ~~price adjustments and chargebacks~~rebates arising from commercial contracts are based on its estimated mix of ~~sales to~~ various third-party payers, which are ~~entitled either~~ contractually ~~or statutorily~~entitled to discounts from the Company’s listed prices of its products. If the ~~sales~~ mix toacross third-party payers is different from the Company’s estimates, the Company may be required to pay higher or lower total price adjustments and/or chargebacks than it had ~~estimated, and such differences may be significant.~~estimated.

Voucher program: The Company, from time to time, offers certain promotional product-related incentives to ~~its customers.~~eligible patients. The Company has voucher programs for BELBUCA, Symproic and BUNAVAIL whereby the Company offers a point-of-sale subsidy to retail consumers. The Company estimates its liabilities for these voucher programs based on the current utilization and historical redemption rates as reported to the Company by a third-party claims processing organization. The Company accounts for the costs of these special promotional programs as price adjustments, which are a reduction of gross revenue.

Trade discounts and distribution fees: Trade discounts relate to prompt settlement discounts provided to customers. In addition, the Company compensates its customers for distribution of its products and data. The Company has determined that such services received to date are not distinct from its sale of products and may not reasonably represent fair value for these services. Therefore, estimates of these payments are recorded as a reduction of revenue based on contractual terms.

Cost of sales

Cost of sales includes the direct costs attributable to the production of BELBUCA, Symproic and BUNAVAIL. It includes raw materials, production costs at the Company’s contract manufacturing sites, quality testing directly related to the products, and depreciation on equipment that the Company has purchased to produce BELBUCA, Symproic and BUNAVAIL. It also

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(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

(Unaudited)

~~Prompt payment discounts~~-The Company typically offers its wholesale customers a prompt payment discount of 2% as an incentive to remit payments within a prescribed number of days after the invoice date depending on the customer and the products purchased.

~~Gross to net accruals~~-A significant majority of the Company’s gross to net adjustments to gross product revenues are the result of accruals for its voucher program and rebates related to Medicare Part D, Part D Coverage Gap, Medicaid and commercial contracts, with most of those programs having an accrual to payment cycle of anywhere from ~~one~~ to three months. In addition to this relatively short accrual to payment cycle, the Company receives daily information from the wholesalers regarding their sales of the Company’s products and actual on hand inventory levels of its products. This enables the Company to execute accurate provisioning procedures. Consistent with the pharmaceutical industry, the accrual to payment cycle for returns is longer and can take several years depending on the expiration of the related products.

~~Cost of sales~~

~~Cost of sales~~ includes the ~~direct~~ costs attributable to the production of BELBUCA and BUNAVAIL. It includes raw materials, production costs at the Company’s three contract manufacturing sites, quality testing directly related to the products, and depreciation on equipment that the Company has purchased to produce BELBUCA and BUNAVAIL. It also includesfor any batches not meeting specifications and raw material yield losses. Yield losses and batches not meeting specifications are expensed as incurred. Cost of sales is recognized when sold to the wholesaler from our distribution center.

~~Since April 2019, cost of sales has also included direct costs attributable to the production of Symproic.~~

For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough cancer pain therapies), cost of sales includes all costs related to creating the product at the Company’s contract manufacturing location in Germany. The Company’s contract manufacturer bills the Company for the final product, which includes materials, direct labor costs, and certain overhead costs as outlined in applicable supply agreements.

Cost of sales also includes royalty expenses that the Company owes to third parties.

Recent accounting pronouncements-adopted

Measurement of Credit Losses of Financial Instruments

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. In May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326). The Company adopted Topic 326 during the three months ended March 31, 2020 and determined that the new guidance has no material impact on its condensed consolidated financial statements.

The Company is exposed to credit losses primarily through its product sales. The Company assesses each counterparty’s ability to pay for the products it sells by conducting a credit review. The credit review considers the Company's expected billing exposure and timing for payment and the counterparty’s established credit rating or the Company's assessment of the counterparty’s creditworthiness based on the Company's analysis of their financial statements when a credit rating is not available. The Company also considers contract terms and conditions, and business strategy in its evaluation. A credit limit is established for each counterparty based on the outcome of this review.

The Company monitors its ongoing credit exposure through active review of counterparty balances against contract terms and due dates. The Company's activities include timely account reconciliations, dispute resolution and payment confirmations. The Company may employ collection agencies and legal counsel to pursue recovery of defaulted receivables.

As of March 31, 2020, the Company reported $44.8 million of trade receivables within accounts receivable. Based on an aging analysis at March 31, 2020, 98% of the Company's accounts receivable were outstanding less than 30 days. There was no change to the allowance for doubtful accounts and credit losses between March 31, 2020 or December 31, 2019. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received.

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019 and early adoption is permitted. The new guidance does not have a material impact on its consolidated financial statements.

In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company has determined that the new guidance does not have a material impact on its consolidated financial statements.

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(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

(Unaudited)

Recent accounting pronouncements-not yet adopted

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 and early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements.

Fair Value of Financial Instruments

The Company measures the fair value of instruments in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.

GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of its cash and cash equivalents to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value:

Level 1 – quoted prices in active markets for identical assets or liabilities

Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions)

The following table summarizes the cash and cash equivalents measured at fair value on a recurring basis as of ~~September 30, 2019:~~March 31, 2020:

Level 1 Level 2 Level 3 Balance at September 30, 2019
Cash and cash equivalents $ 55,863 — — $ 55,863


	Level 1		Level 2	Level 3	Balance at March 31, 2020
Cash and cash equivalents	$	70,613	—	—	$	70,613

The cash and cash equivalent balance as of ~~September 30, 2019~~March 31, 2020 includes investments in various money market accounts and cash held in interest bearing accounts.

2. Inventory:

The following table represents the components of inventory as of:


	March 31, 2020		December 31, 2019
Raw materials & supplies	$	1,794	$	624
Work-in-process	7,255		6,198
Finished goods	6,743		4,874
Obsolescence reserve	(789)		(384)
Total inventories	$	15,003	$	11,312

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(Unaudited)

~~Research and development~~

As of January 1, 2019, the Company has focused entirely on commercialized products rather than research and development. As such, there were 0 expenses incurred in research and development during the nine months ended September 30, 2019. Research and development expense for the nine months ended September 30, 2018 totaled $4.0 million.

~~2. Leases:~~

~~The components of lease expense were as follows:~~

Three months ended September 30, Nine months ended September 30,
2019 2018 2019 2018
Lease Cost
Operating lease cost
Operating lease $ 82 $ 81 $ 246 $ 244
Variable lease costs 3 1 10 1
Total lease cost $ 85 $ 82 $ 256 $ 245

Nine months ended September 30,
2019 2018
Other Information
Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 261 $ 245

Nine months ended September 30,
2019 2018
Lease Term and Discount Rate
Weighted-average remaining lease term Operating leases 3.0 years 4.0 years
Weighted-average discount rate Operating leases 11.8 % 11.8 %

~~Maturity of Lease Liabilities~~

~~Future minimum lease payments under non-cancellable leases as of September 30, 2019 were as follows:~~

Maturity of Lease Liabilities
2019 $ 89
2020 360
2021 370
2022 219
Total lease payments $ 1,038
Less: Interest (152)
Present value of lease liabilities $ 886

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~~(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)~~

~~(Unaudited)~~

~~Components of Lease Assets and Liabilities~~


	September 30, 2019
~~Assets~~
~~Property and equipment, net Operating lease-right of use asset~~	$	~~777~~
~~Liabilities~~
~~Current liabilities Operating lease- current liability~~	$	~~271~~
~~Other long-term liabilities Operating lease- noncurrent liability~~	~~615~~
~~Total lease liabilities~~	$	~~886~~

3. ~~Inventory:~~

~~The following table represents the components of inventory as of:~~

September 30,
2019 December 31,
2018
Raw materials & supplies $ 638 $ 645
Work-in-process 6,894 2,093
Finished goods 3,478 2,855
Obsolescence reserve (244) (187)
Total inventories $ 10,766 $ 5,406

4. Accounts payable and accrued liabilities:

The following table represents the components of accounts payable and accrued liabilities as of:


		September 30, 2019		December 31, 2018			March 31, 2020		December 31, 2019
Accounts payable	Accounts payable	$	2,175	$	3,166	Accounts payable	$	17,699	$	11,704
Accrued rebates	Accrued rebates	24,625		12,261		Accrued rebates	29,172		28,528
Accrued compensation and benefits	Accrued compensation and benefits	4,662		3,814		Accrued compensation and benefits	3,768		5,545
Accrued acquisition costs		9,970		318
Accrued returns	Accrued returns	1,477		715		Accrued returns	6,248		4,438
Accrued royalties	Accrued royalties	419		159		Accrued royalties	733		535
Accrued clinical trial costs		—		464
Accrued legal	Accrued legal	556		70		Accrued legal	1,554		1,484
Accrued interest expense		1,508		—
Accrued regulatory expenses	Accrued regulatory expenses	282		—		Accrued regulatory expenses	547		331
Accrued other	Accrued other	871		572		Accrued other	1,210		1,428
Total accounts payable and accrued liabilities	Total accounts payable and accrued liabilities	$	46,545	$	21,539	Total accounts payable and accrued liabilities	$	60,931	$	53,993

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~~(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)~~

~~(Unaudited)~~

5.4. Property and equipment:

Property and equipment, summarized by major category, consist of the following as of:


		September 30, 2019		December 31, 2018			March 31, 2020		December 31, 2019
Machinery & equipment	Machinery & equipment	$	5,635	$	5,635	Machinery & equipment	$	5,635	$	5,635
Right of use, building lease	Right of use, building lease	777		—		Right of use, building lease	661		720
Computer equipment & software	Computer equipment & software	437		406		Computer equipment & software	437		437
Office furniture & equipment	Office furniture & equipment	161		155		Office furniture & equipment	174		174
Leasehold improvements	Leasehold improvements	43		43		Leasehold improvements	43		43
Idle equipment	Idle equipment	679		679		Idle equipment	679		679
Total	Total	7,732		6,918		Total	7,629		7,688
Less accumulated depreciation and amortization	Less accumulated depreciation and amortization	(4,019)		(3,846)		Less accumulated depreciation and amortization	(5,634)		(5,613)
Total property and equipment, net	Total property and equipment, net	$	3,713	$	3,072	Total property and equipment, net	$	1,995	$	2,075

Depreciation expense for the three-month periods ended ~~September 30,~~March 31, 2020 and March 31, 2019, ~~and September 30, 2018,~~ was approximately ~~$0.08~~$0.02 million and ~~$0.2 million, respectively. Depreciation expense for the nine-month periods ended September 30, 2019 and September 30, 2018, was approximately $0.2 million and $0.7~~$0.1 million, respectively.

6.5. License agreements and acquired product rights:

Shionogi license and supply agreement

On April 4, 2019 (the “Effective Date”), the Company and Shionogi Inc. (“Shionogi”) entered into an exclusive license agreement (the “License Agreement”) for the commercialization of Symproic in the United States including Puerto Rico (the “Territory”) for opioid-induced constipation in adult patients with chronic non-cancer pain (the “Field”).

Pursuant to the terms of the License Agreement, the Company paid Shionogi a $20 million up-front payment on the Effective Date and paid Shionogi a $10 million payment on the six-month anniversary of the Effective Date on October 4, 2019. ~~Furthermore, the~~The Company ~~will pay~~also pays quarterly tiered royalty payments on ~~potential~~ net sales of Symproic in the Territory that range from 8.5% to 17.5% (plus an additional 1% of net sales on a pass-through basis to a third party licensor of Shionogi) of net sales based on volume of net sales and whether Symproic is being sold as an authorized generic. Assets acquired as part of the License Agreement include: intellectual property, inventory, trademarks and tradenames.

The Company and Shionogi also entered into a customary supply agreement under which Shionogi will supply Symproic to the Company at cost plus an agreed upon markup for an initial term of up to two years. In the event the Company elects to source Symproic from a third party supplier, Shionogi would continue to supply the Company with naldemedine tosylate for use in Symproic at cost plus such agreed upon markup for the duration of the License Agreement. The Company and Shionogi also entered into a Pharmacovigilance agreement that required ongoing cooperation on adverse event reporting for the duration of License Agreement.

The Company accounted for the Symproic purchase as an asset acquisition under ASC 805-10-55-5b, which provides guidance for asset acquisitions. Under the guidance, if substantially all the acquisition is made up of one asset or several similar assets, then the acquisition is an asset acquisition. The Company believes that the licensing agreement and other assets acquired from Shionogi are similar and consider them all to be intangible assets.

~~The~~ total purchase price was allocated to the acquired asset based on their relative estimated fair values, as follows:

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(Unaudited)


Symproic license	$	30,000
Transaction expenses	636
Total value	$	30,636

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~~(Unaudited)~~

Additionally, the Company also purchased from Shionogi $0.4 million of Symproic samples, which have been recorded in selling, general and administrative expenses in the accompanying condensed consolidated statement of operations for the nine months ended September 30, 2019.

The Company is amortizing the Symproic license over the life of the underlying patent, which the earliest date of generic entry for Symproic is November 2031 based on the expiration date of US patent # 9,108,975.

7.6. Other intangible assets:

Other intangible assets, net, consisting of product rights and licenses are summarized as follows:


September 30, 2019		Gross Carrying Value		Accumulated Amortization		Intangible Assets, net
March 31, 2020								March 31, 2020	Gross Carrying Value		Accumulated Amortization		Intangible Assets, net
Product rights	Product rights	$	6,050	$	(5,864)	$	186	Product rights	$	6,050	$	(6,050)	$	—
BELBUCA license and distribution rights	BELBUCA license and distribution rights	45,000		(12,374)		32,626		BELBUCA license and distribution rights	45,000		(14,625)		30,375
Symproic license and distribution rights	Symproic license and distribution rights	30,636		(1,218)		29,418		Symproic license and distribution rights	30,636		(2,435)		28,201
Licenses		1,900		(1,875)		25
Total intangible assets	Total intangible assets	$	83,586	$	(21,331)	$	62,255	Total intangible assets	$	81,686	$	(23,110)	$	58,576


December 31, 2018		Gross Carrying Value		Accumulated Amortization		Intangible Assets, net
December 31, 2019								December 31, 2019	Gross Carrying Value		Accumulated Amortization		Intangible Assets, net
Product rights	Product rights	$	6,050	$	(5,442)	$	608	Product rights	$	6,050	$	(6,003)	$	47
BELBUCA license and distribution rights	BELBUCA license and distribution rights	45,000		(9,000)		36,000		BELBUCA license and distribution rights	45,000		(13,500)		31,500
Licenses		1,900		(1,805)		95
Symproic license and distribution rights								Symproic license and distribution rights	30,636		(1,827)		28,809
Total intangible assets	Total intangible assets	$	52,950	$	(16,247)	$	36,703	Total intangible assets	$	81,686	$	(21,330)	$	60,356

8.7. Notes payable:

On May 23, 2019, the Company entered into a Loan Agreement (the “Loan Agreement”) with Biopharma Credit plc (“Pharmakon”), for a senior secured credit facility consisting of a term loan of $60.0 million (the “Term Loan”), with the ability to draw an additional $20.0 million within twelve months of the closing date. The Loan Agreement replaced the Company’s previous Term Loan Agreement ~~(the “Original Loan Agreement”)~~ with CRG Servicing LLC ~~(“CRG”~~("CRG").

The Company utilized $60.0 million of the initial loan proceeds under the Loan Agreement, plus an additional $1.8 million to repay all of the outstanding loan balance owed by the Company under the Original Loan Agreement. The Company also used existing cash on hand to pay a $5.6 million backend facility fee to CRG. Upon the repayment of all amounts owed by the Company under the CRG Original Loan Agreement, all commitments to CRG were terminated and all security interests granted by the Company and its subsidiary guarantors under the CRG Original Loan Agreement were released.

During the nine months ended September 30, 2019, the Company expensed one-time events of $5.2 million in unamortized deferred loan fees, $3.9 million in unamortized warrant discount costs and $2.8 million in loan prepayment fees and realized losses arising out of the CRG Term Loan and recorded as interest expense in the accompanying consolidated statement of operations.

The new facility carries a 72-month term with interest only payments on the term loan for the first 36 months. The Term Loan will mature in May 2025 and bears an interest rate of 7.5% plus the LIBOR rate on the first day for the quarter (LIBOR effective rate as of ~~July~~January 1, ~~2019~~2020 was ~~2.33%~~2.00%.) The Term Loan is subject to mandatory prepayment provisions that require prepayment upon change of control.

The debt balance had been categorized within Level 2 of the fair value hierarchy. The carrying amount of the debt approximates its fair value based on prevailing interest rates as of the balance sheet date.

The following table represents future maturities of the notes payable obligation as of March 31, 2020:

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(Unaudited)

~~The following table represents future maturities of the notes payable obligation as of September 30, 2019:~~


2019		—
2020	2020	—		2020	—
2021	2021	—		2021	—
2022	2022	13,846		2022	13,846
2023	2023	18,462		2023	18,462
2024	2024	18,462		2024	18,462
2025	2025	9,230		2025	9,230
Total maturities	Total maturities	$	60,000	Total maturities	$	60,000
Unamortized discount and loan costs	Unamortized discount and loan costs	(1,485)		Unamortized discount and loan costs	(1,366)
Total notes payable obligation	Total notes payable obligation	$	58,515	Total notes payable obligation	$	58,634

9.8. Net sales by product:

The Company’s business is classified as a single reportable segment.

However, the following table presents net sales by product:


		Three months ended September 30,						Nine months ended September 30,									Three months ended March 31,
		2019		2018		2019		2018			2020			2019
BELBUCA	BELBUCA	$	26,514	$	12,358	$	69,277	$	30,128	BELBUCA	$	33,469		$	18,703
% of net product sales										% of net product sales	89		%	95		%
Symproic	Symproic	2,172		—		5,348		—		Symproic	4,179			—
% of net product sales										% of net product sales	11		%	—
BUNAVAIL	BUNAVAIL	937		1,405		2,813		4,239		BUNAVAIL	67			1,056
% of net product sales										% of net product sales	—		%	5		%
Net product sales	Net product sales	$	29,623	$	13,763	$	77,438	$	34,367	Net product sales	$	37,715		$	19,759

In March 2020 the company announced it will discontinue marketing of BUNAVAIL in the U.S. in 2020.

~~10.~~

9. Stockholders’ equity:

~~Public Offering~~

On April 15, 2019 the Company completed an underwritten public offering by the Company and a selling stockholder of 12,000,000 shares of common stock at a public offering price of $5.00 per share. The gross proceeds from the Company’s portion of the offering (10,000,000 shares), before deducting the underwriter discounts and commission and other offering expenses, was $50.0 million. The net proceeds were $47.6 million. The gross proceeds to the selling stockholder were approximately $19.0 million, which includes shares sold pursuant to the underwriters’ exercise of their option to purchase an additional 1,800,000 shares of common stock at the public offering price.

~~Common Stock~~

On July 25, 2019, in connection with the Company’s 2019 Annual Meeting of Stockholders (“the Annual Meeting”), the Company’s stockholders approved, among other matters, an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of Common Stock from 125,000,000 to 175,000,000. Shareholders also approved the Company’s 2019 Stock Option and Incentive Plan (the “2019 Plan”), which reserves 14,000,000 shares of stock for issuance under the 2019 Plan.

Stock-based compensation

During the ~~nine~~three months ended ~~September 30, 2019,~~March 31, 2020, a total of ~~2,267,904~~2,260,505 options to purchase Common Stock, with an aggregate fair market value of approximately ~~$9.5~~$13.3 million, were granted to employees, officers and ~~directors~~a director of the Company. Options have a term of 10 years from the grant date. Options granted to employees, officers and directors vest ratably over a three-year ~~period and options~~

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~~(Unaudited)~~

~~granted to members of the Board of Directors vest ratably through 2022.~~period. The fair value of each option is amortized as compensation expense evenly through the vesting period.

The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on implied volatilities from historical volatility of the Common Stock, and other factors estimated over the expected term of the options.

Expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term.

The key assumptions used in determining the fair value of options granted during the ~~nine~~three months ended ~~September 30, 2019 follows:~~


~~Expected price volatility~~			~~61.80%-64.10%~~
~~Risk-free interest rate~~			~~1.36%-2.66%~~
~~Weighted average expected life in years~~			~~6 years~~
~~Dividend yield~~			—

~~Option activity during the nine months ended September 30, 2019 was as follows:~~

Number of
shares Weighted average
exercise price per
share Aggregate
intrinsic
value
Outstanding at January 1, 2019 4,406,004 $ 3.19 $ 4,172
Granted in 2019:
Officers and Directors 1,132,109 3.93
Employees 1,135,795 4.46
Exercised (412,500) 4.60
Forfeitures (490,342) 3.97
Outstanding at September 30, 2019 5,771,066 $ 3.53 $ 5,627

As of September 30, 2019, options exercisable totaled 1,903,370. There are approximately $5.6 million of unrecognized compensation cost related to non-vested share-based compensation awards, including options and restricted stock units (“RSUs”) granted. These costs will be expensed through 2022.

~~Restricted stock units~~

During the nine months ended September 30, 2019, a cumulative total of 360,250 RSUs were granted to the Company’s executive officers, members of senior management, a former officer and directors with a fair market value of approximately $1.6 million. The fair value of restricted units is determined using quoted market prices of the Common Stock and the number of shares expected to vest.

~~RSU grants are time-based, all of which generally vest from a one to three-year period. The RSU grant to the former officer vested on his retirement date April 30, 2019.~~

~~Restricted stock activity during the nine months ended September 30, 2019 was as~~March 31, 2020 follows:

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Number of
restricted
shares Weighted
average fair
market value
per RSU
Outstanding at January 1, 2019 2,166,102 $ 2.59
Granted:
Executive officers 223,250 4.44
Directors 90,000 4.85
Employees 47,000 4.67
Vested (801,661) 4.80
Forfeitures (87,132) 2.30
Outstanding at September 30, 2019 1,637,559 $ 3.23


Expected price volatility			59.00%-61.76%
Risk-free interest rate			0.51%-1.68%
Weighted average expected life in years			6 years
Dividend yield			—

~~Preferred Stock~~

~~During~~Option activity during the ~~nine~~three months ended ~~September 30, 2019, 1,402 shares of Series B Preferred Stock (“Series B”) were converted into 7,788,888 shares of Common Stock.~~ March 31, 2020 was as follows:


	Number of shares	Weighted average exercise price per share		Aggregate intrinsic value
Outstanding at January 1, 2020	5,496,971	$	3.64	$	15,455
Granted in 2020:
Officers and Directors	1,074,998	6.08
Employees	1,185,517	5.67
Exercised	(107,287)	3.15
Forfeitures	(171,060)	3.68
Outstanding at March 31, 2020	7,479,139	$	4.32	$	3,336

As of ~~September 30, 2019, 1,698 shares~~March 31, 2020, options exercisable totaled 2,369,440. There are approximately $12.7 million of ~~Series B are outstanding. As of September 30, 2019, 2,093,155 shares of Series A Preferred Stock~~unrecognized compensation costs related to non-vested share-based compensation awards, including options and restricted stock units (“~~Series A”~~RSUs”) ~~are outstanding. There were 0 conversions of Series A during the nine months ended September 30, 2019.~~granted. These costs will be expensed through 2023.

~~Earnings Per Share~~Restricted stock units

Three months ended September 30, Nine months ended September 30,
2019 2018 2019 2018
Basic:
Net income (loss) $ 354 $ (6,380) $ (14,609) $ (26,859)
Less deemed dividend related to beneficial conversion feature on Series B Preferred Stock — (12,500) — (12,500)
Net earnings (loss) attributable to common stockholders $ 354 $ (18,880) $ (14,609) $ (39,359)
Weighted average common shares outstanding 89,649,922 64,900,007 81,612,112 60,599,456
Basic earnings (loss) per common share $ — $ (0.29) $ (0.18) $ (0.65)
Diluted:
Effect of dilutive securities:
Net income (loss) attributable to common stockholders, diluted $ 354 $ (18,880) $ (14,609) $ (39,359)
Weighted average common shares outstanding 89,649,922 64,900,007 81,612,112 60,599,456
Effect of dilutive options and warrants 15,488,972 — — —
Dilutive weighted average common shares outstanding 105,138,894 64,900,007 81,612,112 60,599,456
Diluted earnings (loss) per common share $— $(0.29) $(0.18) $(0.65)

During the three months ended ~~September 30, 2019, outstanding~~March 31, 2020, a cumulative total of 229,769 RSUs were granted to the Company’s executive officers, a member of senior management, and a director with a fair market value of approximately $1.3 million. The fair value of restricted units is determined using quoted market prices of the Common Stock and the number of shares expected to vest. RSU grants are time-based, all of which generally vest from a one to three-year period.

Restricted stock ~~options, RSUs, warrants and preferred shares of 15,488,972 were included in the computation of diluted earnings per common share. During~~activity during the three months ended ~~September 30, 2018, outstanding stock options, RSUs,~~March 31, 2020 was as follows:


	Number of restricted shares	Weighted average fair market value per RSU
Outstanding at January 1, 2020	1,648,559	$	3.86
Granted:
Executive officers	201,314	5.52
Directors	16,000	4.46
Employees	12,455	5.52
Vested	(459,670)	4.36
Forfeitures	(407,217)	3.45
Outstanding at March 31, 2020	1,011,441	$	3.66

Warrants:

The Company has granted warrants ~~and preferred~~to purchase shares of ~~25,745,108~~Common Stock. Warrants may be granted to affiliates in connection with certain agreements. There were ~~not included in~~no warrants issued during the ~~computation~~three months ended March 31, 2020 and as of March 31, 2020, a cumulative of 2,136,019 warrants remain outstanding.

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~~of diluted earnings per common share, because to do so would have had an antidilutive effect.~~ Preferred Stock

During the ~~nine~~three months ended ~~September 30, 2019 and 2018,~~March 31, 2020, 175 shares of Series B Preferred Stock (“Series B”) were converted into 972,222 shares of Common Stock. As of March 31, 2020, 443 shares of Series B are outstanding.

During the three months ended March 31, 2020, 2,093,155 shares of Series A Preferred Stock (“Series A”) were converted on a one-for-one basis into shares of Common Stock. There are 0 remaining outstanding shares of Series A as of March 31, 2020.

Earnings Per Share


	Three months ended March 31,
	2020		2019
Basic:
Net income (loss) attributable to common stockholders	$	4,966	$	(3,833)
Weighted average common shares outstanding	97,118,267		71,344,831
Basic earnings (loss) per common share	$	0.05	$	(0.05)
Diluted:
Effect of dilutive securities:
Net income (loss) attributable to common stockholders, diluted	$	4,966	$	(3,833)
Weighted average common shares outstanding	97,118,267		71,344,831
Effect of dilutive options and warrants	9,847,495		—
Dilutive weighted average common shares outstanding	106,965,762		71,344,831
Diluted earnings (loss) per common share	$0.05		$(0.05)

During the three months ended March 31, 2020, outstanding stock options, RSUs, warrants and preferred shares of ~~15,260,949~~9,847,495 were included in the computation of diluted earnings per common share. During the three months ended March 31, 2019, outstanding stock options, RSUs, warrants and ~~18,917,774, respectively,~~preferred shares of 24,743,605 were not included in the computation of diluted earnings per common share, because to do so would have had an antidilutive effect. ~~Included in the three and nine months ended September 30, 2019 and 2018 are the Series B shares as converted to common stock.~~

~~11.~~10. Commitments and contingencies:

The Company is involved from time to time in routine legal matters incidental to our business. Based upon available information, the Company believes that the resolution of such matters will not have a material adverse effect on its condensed consolidated financial position or results of operations. Except as discussed below, the Company is not the subject of any pending legal proceedings and, to the knowledge of management, no proceedings are presently contemplated against the Company by any federal, state or local governmental agency.

Indivior (formerly RB Pharmaceuticals Ltd.) and Aquestive Therapeutics (formerly MonoSol Rx)

The following disclosure regarding the Company’s ongoing litigations with Aquestive Therapeutics, Inc. (formerly MonoSol Rx, “Aquestive”) and Indivior PLC (formerly RB Pharmaceuticals Limited, “Indivior”) is intended to provide some background and an update on the matter as ~~required by the rules~~per disclosure requirements of the SEC. Additional details regarding the past procedural history of the matter can be found in the Company’s previously filed periodic filings with the SEC.

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Litigation related to BUNAVAIL

On October 29, 2013, Reckitt Benckiser, Inc., Indivior, and Aquestive (collectively, the “RB Plaintiffs”) filed an action against the Company relating to its BUNAVAIL product in the United States District Court for the Eastern District of North Carolina (“EDNC”) for alleged patent infringement. BUNAVAIL is a drug approved for the maintenance treatment of opioid dependence. The RB Plaintiffs claim that the formulation for BUNAVAIL, which has never been disclosed publicly, infringes its US Patent No. 8,475,832 (the “‘832 Patent”). On May 21, 2014, the Court granted the Company’s motion to dismiss.

On January 22, 2014, Aquestive initiated an inter partes review (“IPR”) on U.S. Patent No. 7,579,019, the (“‘019 Patent”). The PTAB upheld all claims of the Company’s ‘019 Patent in 2015 and this decision was not appealed by Aquestive.

On September 20, 2014, the Company proactively filed a declaratory judgment action in the United States District Court for the EDNC requesting the Court to make a determination that the Company’s BUNAVAIL product does not infringe the ‘832 Patent, US Patent No. 7,897,080 (the “‘080 Patent”) and US Patent No. 8,652,378 (the “‘378 Patent”). The Company invalidated the “‘080 Patent” in its entirety in an inter partes reexamination proceeding. The Company invalidated all relevant claims of the ‘832 Patent in an IPR proceeding. And, in an IPR proceeding for the ‘378 Patent, in its decision not to institute the IPR proceeding, the PTAB construed the claims of the ‘378 Patent narrowly. Shortly thereafter, by joint motion of the parties, the ‘378 Patent was subsequently removed from the action.

On June 6, 2016, in an unrelated case in which Indivior and Aquestive asserted the ‘832 Patent against other parties, the Delaware District Court entered an order invalidating other claims in the ‘832 Patent. Indivior and Aquestive cross-appealed all adverse findings in that decision to the Court of Appeals for the Federal Circuit in Case No. 17-2587. The Company’s declaratory judgment action remains stayed pending the outcome of that cross-appeal by Indivior and Aquestive.

On September 22, 2014, the RB Plaintiffs filed an action against the Company (and the Company’s commercial partner) relating to the Company’s BUNAVAIL product in the United States District Court for the District of New Jersey for alleged patent infringement. The RB Plaintiffs claim that BUNAVAIL, whose formulation and manufacturing processes have never been disclosed publicly, infringes its patent U.S. Patent No. 8,765,167 (the “‘167 Patent”). The Company believes this is an anticompetitive attempt by the RB Plaintiffs to distract the Company’s efforts from commercializing BUNAVAIL. On December 12, 2014, the Company filed a motion to transfer the case from New Jersey to North Carolina and a motion to dismiss the case against its commercial partner.

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On October 28, 2014, the Company filed multiple IPR petitions on certain claims of the ‘167 Patent. The USPTO instituted three of the four IPR petitions. The PTAB upheld the claims and denied collateral estoppel applied to the PTAB decisions in March 2016. The Company appealed to Court of Appeals for the Federal Circuit. The USPTO intervened with respect to whether collateral estoppel applied to the PTAB. On June 19, 2018, the Company filed a motion to remand the case for further consideration by the PTAB in view of intervening authority. On July 31, 2018, the Federal Circuit vacated the decisions, and remanded the ‘167 Patent IPRs for further consideration on the merits. On February 7, 2019, the PTAB issued three decisions on remand purporting to deny institution of the three previously instituted IPRs of the ‘167 patent. On March 11, 2019, the Company timely appealed the PTAB decisions on remand to U.S. Court of Appeal for the Federal Circuit. On March 20, 2019, Aquestive and Indivior moved to dismiss the appeal, and the Company opposed that motion. On August 29, 2019, a three-judge panel of the Court of Appeals for the Federal Circuit granted the motion and dismissed the Company’s appeal. On September 30, 2019, the Company filed a petition for an en banc rehearing of the order dismissing the Company’s appeal by the full Federal Circuit Court of Appeals.

Litigation related to BELBUCA

On January 13, 2017, Aquestive filed a complaint in the United States District Court for the District of New Jersey alleging BELBUCA infringes the ‘167 Patent. In lieu of answering the complaint, the Company filed motions to dismiss the complaint and, in the alternative, to transfer the case to the EDNC. On July 25, 2017, the New Jersey Court administratively terminated the case pending the parties submission of a joint stipulation of transfer because the District of New Jersey was an inappropriate venue. This case was later transferred to the Delaware District Court. On October 31, 2017, the Company filed motions to dismiss the complaint and, in the alternative, to transfer the case to the EDNC. On October 16, 2018, denying the motion to dismiss as moot, the Delaware District Court granted the Company’s motion to transfer the case to the EDNC. On November 20, 2018, the Company moved the EDNC to dismiss the complaint for patent infringement for failure to state a claim for relief.

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On August 6, 2019, the EDNC granted the Company’s motion to dismiss, and dismissed the complaint without prejudice. On or about November 11, 2019, Aquestive refiled a complaint in the EDNC against the Company alleging that BELBUCA infringes the ‘167 Patent. The Company strongly refutes as without merit Aquestive’s assertion of patent infringement and will vigorously defend the lawsuit.

Teva Pharmaceuticals USA (formerly Actavis)

On February 8, 2016, the Company received a notice relating to a Paragraph IV certification from Teva Pharmaceuticals USA, or (formerly Actavis, “Teva”) seeking to find invalid three Orange Book listed patents relating specifically to BUNAVAIL. The Paragraph IV certification related to an ANDA filed by Teva with the FDA for a generic formulation of BUNAVAIL. The patents subject to Teva’s certification were the ‘019 Patent, U.S. Patent No. 8,147,866 (the “‘866 Patent”) and 8,703,177 (the “‘177 Patent”).

On March 18, 2016, the Company asserted three different patents against Teva, the ‘019 Patent, the ‘866 Patent, and the ‘177 Patent. Teva did not raise non-infringement positions about the ‘019 and the ‘866 Patents in its Paragraph IV certification. Teva did raise a non-infringement position on the ‘177 Patent but the Company asserted in its complaint that Teva infringed the ‘177 Patent either literally or under the doctrine of equivalents.

On December 20, 2016 the USPTO issued U.S. Patent No. 9,522,188 (the “‘188 Patent””), and this patent was properly listed in the Orange Book as covering the BUNAVAIL product. On February 23, 2017 Teva sent a Paragraph IV certification adding the 9,522,188 to its ANDA. An amended Complaint was filed, adding the ‘188 Patent to the litigation.

On January 31, 2017, the Company received a notice relating to a Paragraph IV certification from Teva relating to Teva’s ANDA on additional strengths of BUNAVAIL and on March 16, 2017, the Company brought suit against Teva and its parent company on these additional strengths. On June 20, 2017, the Court entered orders staying both BUNAVAIL suits at the request of the parties.

On May 23, 2017, the USPTO issued U.S. Patent 9,655,843 (the “‘843 Patent”) relating to the BEMA technology, and this patent was properly listed in the Orange Book as covering the BUNAVAIL product.

Finally, on October 12, 2017, the Company announced that it had entered into a settlement agreement with Teva that resolved the Company’s BUNAVAIL patent litigation against Teva pending in the U.S. District Court for the District of Delaware. As part of the Settlement Agreement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department

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of Justice, the Company has entered into a non-exclusive license agreement with Teva that permits Teva to first begin selling its generic version of BUNAVAIL in the U.S. on July 23, 2028 or earlier under certain circumstances. Other terms of the agreement are confidential.

The Company received notices regarding Paragraph IV certifications from Teva on November 8, 2016, November 10, 2016, and December 22, 2016, seeking to find invalid two Orange Book listed patents relating specifically to BELBUCA. The Paragraph IV certifications relate to three ANDAs filed by Teva with the FDA for a generic formulation of BELBUCA. The patents subject to Teva’s certification were the ‘019 Patent and the ‘866 Patent. The Company filed complaints in Delaware against Teva on December 22, 2016 and February 3, 2017 in which it asserted against Teva the ‘019 Patent and the ‘866 Patent. Teva did not contest infringement of the claims of the ‘019 Patent and did not contest infringement of the claims of the ‘866 Patent. The ‘019 Patent had already been the subject of an unrelated IPR before the USPTO under which the Company prevailed, and all claims of the ‘019 Patent survived. Aquestive’s request for rehearing of the final IPR decision regarding the ‘019 Patent was denied by the USPTO on December 19, 2016. Aquestive did not file a timely appeal at the Federal Circuit.

On August 28, 2017, the Court entered orders staying both BELBUCA suits at the request of the parties.

In February 2018, the Company announced that it had entered into a settlement agreement with Teva that resolved the Company’s BELBUCA patent litigation against Teva pending in the U.S. District Court for the District of Delaware. As part of the settlement agreement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice,

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the Company has granted Teva a non-exclusive license (for which the Company will receive no current or future payments) that permits Teva to first begin selling the generic version of the Company’s BELBUCA product in the U.S. on January 23, 2027 or earlier under certain circumstances (including, for example, upon (i) the delisting of the patents-in-suit from the U.S. FDA Orange Book, (ii) the granting of a license by us to a third party to launch another generic form of BELBUCA at a date prior to January 23, 2027, or (iii) the occurrence of certain conditions regarding BELBUCA market share). Other terms of the Agreement are confidential.

Alvogen

On September 7, 2018, the Company filed a complaint for patent infringement in Delaware against Alvogen Pb Research & Development LLC, Alvogen Malta Operations Ltd., Alvogen Pine Brook LLC, Alvogen, Incorporated, and Alvogen Group, Incorporated (collectively, “Alvogen”), asserting that Alvogen infringes the Company’s Orange Book listed patents for BELBUCA®, including U.S. Patent Nos. 8,147,866 and 9,655,843, both expiring in July of 2027, and U.S. Patent No. 9,901,539, expiring in December of 2032. This complaint follows receipt by the Company on July 30, 2018 of a Paragraph IV Patent Certification from Alvogen stating that Alvogen had filed an ANDA with the FDA for a generic version of BELBUCA® Buccal Film (75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg and 900 mcg). Because the Company initiated a patent infringement suit to defend the patents identified in the Paragraph IV notice within 45 days after receipt of the Paragraph IV Certification, the FDA is prevented from approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid. Alvogen’s notice letter also does not provide any information on the timing or approval status of its ANDA.

In its Paragraph IV Certification, Alvogen does not contest infringement of at least several independent claims of each of the ’866, ’843, and ’539 patents. Rather, Alvogen advances only invalidly arguments for these independent claims. The Company believes that it will be able to prevail on its claims of infringement of these patents, particularly as Alvogen does not contest infringement of certain claims of each patent. Additionally, as the Company has done in the past, it intends to vigorously defend its intellectual property against assertions of invalidity. Each of the three patents carry a presumption of validity, which can only be overcome by clear and convincing evidence.

2018 Arkansas Opioid Litigation

On March 15, 2018, the State of Arkansas, and certain counties and cities in that State, filed an action in the Circuit Court of Arkansas, Crittenden County against multiple manufacturers, distributors, retailers, and prescribers of opioid analgesics,

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including the Company. The Company was served with the complaint on April 27, 2018. The complaint specifically alleged that it licensed its branded fentanyl buccal soluble film ONSOLIS to Collegium, and Collegium is also named as a defendant in the lawsuit. ONSOLIS is not presently sold in the United States and the license agreement with Collegium was terminated prior to Collegium launching ONSOLIS in the United States. Therefore, on June 28, 2018, the Company moved to dismiss the case against it and most recently, on July 6, 2018, the plaintiffs filed a notice to voluntarily dismiss us from the Arkansas case, without prejudice.

Chemo Research, S.L

On March 1, 2019, the Company filed a complaint for patent infringement in Delaware against Chemo Research, S.L., Insud Pharma S.L., IntelGenx Corp., and IntelGenx Technologies Corp. (collectively, “Defendants”), asserting that the Defendants infringe its Orange Book listed patents for BELBUCA, including U.S. Patent Nos. 8,147,866 and 9,655,843, both expiring in July of 2027, and U.S. Patent No. 9,901,539 expiring December of 2032. This complaint follows a receipt by the Company on January 31, 2019, of a Notice Letter from Chemo Research S.L. stating that it has filed with the FDA an ANDA containing a Paragraph IV Patent Certification, for a generic version of BELBUCA Buccal Film in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, and 900 mcg. Because the Company initiated a patent infringement suit to defend the patents identified in the Notice Letter within 45 days after receipt, the FDA is prevented from approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid. Chemo Research S.L.’s Notice Letter also does not provide any information on the timing or approval status of its ANDA. On March 15, 2019, the Company filed a complaint against the Defendants in New Jersey asserting the same claims for patent infringement made in the Delaware lawsuit. On April 19, 2019, Defendants filed an answer to the Delaware complaint wherein they denied infringement of the ‘866, ‘843 and ‘539 patents and asserted counterclaims seeking declaratory relief concerning the alleged invalidity and non-infringement of such patents.

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(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)

(Unaudited)

On April 25, 2019, the Company voluntarily dismissed the New Jersey lawsuit given Defendants’ consent to jurisdiction in Delaware.

The Company believes that it will be able to prevail in this lawsuit. As it has done in the past, the Company intends to vigorously defend its intellectual property against assertions of invalidity.

Derivative Litigation

On July 2, 2018, the Company filed a Schedule 14A Proxy Statement (the “Proxy”) with the U.S. Securities and Exchange Commission (the “SEC”) in connection with its 2018 Annual Meeting. Proposals 1 and 2 of the Proxy sought stockholder approval to amend the Company’s Certificate of Incorporation by deleting Article TWELFTH of the Company’s Certificate of Incorporation in its entirety and replacing it with a new Article TWELFTH that, among other things (i) provided for the declassification of the Company’s Board in phases, with the full declassification to be achieved in 2020 (the “Declassification Amendment”) and (ii) changed the voting standard for the uncontested election of directors to the Board from a plurality standard to the majority of votes cast standard as set forth in the bylaws of the Company (the “Election Amendment” and together with the “Declassification Amendment”, the “Amendments”).

On August 2, 2018, the Company held the 2018 Annual Meeting, at which time the stockholders voted on the Amendments. Following the 2018 Annual Meeting, based on consultation with the Company’s advisors, the Company determined that the Amendments had been adopted by the requisite vote of stockholders and effected the Amendments by filing a Certificate of Amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware on August 6, 2018.

On September 11, 2019, two purported stockholders of the Company filed a putative class action against the Company and our directors in the Court of Chancery of the State of Delaware, captioned Drachman v. BioDelivery Sciences International, Inc., et al., C.A. No. 2019-0728-AGB (Del. Ch.) (the “Complaint”). The Complaint alleges that the Amendments did not receive the requisite vote of stockholders at the 2018 Annual Meeting and asserts claims for violation of the Delaware General Corporation Law, breach of fiduciary duties, and declaratory judgment. The Complaint seeks, inter alia, a declaration that the Amendments were not validly approved and invalidation of the Amendments, including altering the one-year terms of all directors duly elected at the 2018 and 2019 Annual Meetings to three-year terms. The Complaint also seeks costs and disbursements, including attorneys’ fees. The Company will respond to the complaint ~~by the December 6, 2019 deadline set by the Court~~ and defend against it vigorously.

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~~BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES~~

~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~

~~(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)~~

~~(Unaudited)~~

On November 5, 2019, the Board determined that ratifying the declassification of the Board and the change in the voting standard as set forth in the Amendments, as well as ratifying the filing and effectiveness of the Amendments, is in the best interests of the Company and its stockholders. The Board thus approved resolutions ratifying such acts and the filing and effectiveness of the Amendments under Section 204 of the Delaware General Corporation Law. The Company will submit the ratification to its stockholders for their adoption in accordance with Section 204 at its 2020 Annual Meeting.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis should be read in conjunction with the Condensed Consolidated Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. Our actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in our other filings with the SEC. See “Cautionary Note Regarding Forward-Looking Statements” below.

Overview

Strategy

Our strategy is evolving with the establishment of our commercial footprint in the management of chronic ~~conditions.~~pain. We seek to continue to build a well-balanced, diversified, high-growth specialty pharmaceutical company. Through our industry-leading commercialization infrastructure, we are executing the commercialization of our existing products. As part of our corporate growth strategy, we have licensed, and will continue to explore opportunities to acquire or license, additional products that meet the needs of patients living with debilitating chronic conditions and treated primarily by therapeutic specialists. As we gain access to these drugs and technologies, we ~~intend~~plan to employ our commercialization experience to bring them to the marketplace. With a strong commitment to patient access and a focused business-development approach for transformative acquisitions or licensing opportunities, we ~~intend~~plan to leverage our experience and apply it to developing new partnerships that enable us to commercialize novel products that can change the lives of people suffering from debilitating chronic conditions.

~~Third~~Our commercial strategy for BELBUCA is to further drive continued adoption in the large long-acting opioid market based on its unique profile coupled with growing physician interest, policy tailwinds, and expanding payer access. We aim to leverage the specialized commercial infrastructure we established for BELBUCA as a vehicle to enable commercial growth in Symproic, which is increasingly seen as a complementary asset.

First Quarter and Recent Highlights

•On ~~July 1, 2019,~~January 6, 2020, we ~~were added to~~announced the ~~broad-market Russell 3000® Index~~appointment of Kevin Ostrander as ~~well as the Russell 2000® Index at the conclusion~~Senior Vice President of Business Development and member of the ~~2019 Russell indexes annual reconstitution.~~Company Executive Leadership Team.

•On ~~July 9, 2019,~~February 27, 2020, we ~~announced that several regional health care plans improved patient access to BELBUCA during~~presented at the ~~second quarter~~American Academy of this year. The regional U.S. insurance plans enhance BELBUCA’s coverage to preferred status or initiated coverage for BELBUCA, which means that an additional six million covered lives now have access to BELBUCA. These six million covered lives bringsPain Medicine’s (AAPM) 36th Annual Meeting, positive results of a study titled, “A Phase I Placebo-Controlled Trial Comparing the ~~total number~~Effect of ~~commercial lives with access to BELBUCA to more than 165 million, representing more than 90% of the U.S. commercial insurance market.~~Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory Drive”.

•On August. 28, 2019, we reported the acceptance of five scientific abstracts highlighting data supporting our portfolio of products that address the unmet need of chronic conditions at the PAINWeek® 2019 National Conference on Pain for Frontline Practitioners which took place in September in Las Vegas, NV.

•~~On October 1, 2019,~~March 9, 2020, we announced ~~that a major pharmacy benefits manager ("PBM") begin providing improved patient access~~the appointment of Jeffrey A. Bailey to ~~BELBUCA and Symproic starting October 1, 2019, with full plan adoption expected by January 1, 2020. The addition~~our Board of this large national PBM will increase the number of covered lives to approximately 14 million covered lives within both commercial and health exchange plans that have access to BELBUCA as either the preferred or preferred exclusive buprenorphine product within their respective plans and Symproic as the preferred exclusive product within its class. Further, this addition brings the total number of covered lives with preferred access to BELBUCA to more than 104 million (out of more than 165 million with coverage) and the total number of covered lives with access to Symproic to more than 76 million.Directors.

Our Products ~~and Related Trends~~

Our product portfolio currently consists of four products that are approved by the FDA. Three of our products utilize our patented BEMA thin film drug delivery technology.

BELBUCA

BELBUCA (buprenorphine buccal film) is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate. BELBUCA is differentiated from other opioids and has the potential to address some of the most critical issues facing healthcare providers treating chronic pain with prescription opioids – abuse, misuse, addiction and the risk of overdose. Compared to currently marketed products and products under development, we believe that BELBUCA is differentiated based on the following features:

•strong and durable efficacy in both opioid naïve and opioid experienced patients;

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•Schedule III designation by DEA, which indicates less abuse and addiction potential compared to Schedule II opioids, which include oxycodone, hydrocodone and morphine;

•in published studies, investigators observed that respiratory depression from buprenorphine administration reached a plateau, and we believe this ceiling effect may result in a lower risk of overdose related respiratory depression;

•favorable tolerability with a low incidence of constipation and low discontinuation rate;

•flexible dosing options with seven available strengths; and

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•buccal administration to optimize buprenorphine delivery.

We believe that there are long-term growth opportunities for BELBUCA and we focus our commercial efforts primarily on BELBUCA. Our sales force is focused on current BELBUCA prescribers, chronic pain management specialists, and clinicians we believe have the greatest opportunity to be adopters of BELBUCA. As of January ~~2019,~~2020, BELBUCA had formulary coverage for more than ~~92%~~96% of commercial lives.

Additionally, we recently completed a Phase I placebo-controlled study to compare the effects of BELBUCA and oral oxycodone hydrochloride (a full μ-opioid receptor agonist) on respiratory drive, as measured by the ventilatory response to hypercapnia (VRH) after drug administration. While analyses of the data is currently ongoing, our primary endpoint showed there was no significant change in respiratory drive compared to placebo for any dose of BELBUCA (300, 600, or 900 mcg) and there was worsening respiratory drive compared to placebo for oxycodone, and it was statistically significant at the 60mg dose.

The risks to our company associated with BELBUCA include: (i) inability to continue to manufacture adequate supplies for commercial use; (ii) unexpected product safety issues; (iii) failure of our sales force to effectively sell the product and, (iv) inadequate reimbursement. A technical or commercial failure of BELBUCA would have a material adverse effect on our future revenue potential and would negatively affect investor confidence in our company and our public stock price.

SYMPROIC

Symproic is a peripherally acting mu-opioid receptor antagonist ~~or PAMORA,~~("PAMORA"), and was approved by the FDA on March 23, 2017 for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. OIC occurs primarily via activation of enteric mu-receptors in the small intestine and proximal colon, which results in harder stool and less frequent and less effective defecation. Because OIC results from the specific effects of opioids, it differs mechanistically from other forms of constipation, and deserves dedicated medical management. Compared to currently marketed products and products under development for OIC, we believe that Symproic is differentiated based on the following features:

•strong and durable efficacy observed in randomized, double-blind, placebo controlled clinical trials of 12 week and 52 week duration in OIC patients;

•OIC relief that was more frequent, more complete, with less straining than patients taking placebo

•recommended by the American Gastroenterological Association for patients with laxative refractory OIC;

•adverse event profile comparable to placebo, with low rates of abdominal pain observed across the phase III program; and

•the only prescription OIC medication with the convenience of once daily dosing, with only a tablet strength, and that can be taken with or without food and with or without laxatives.

Because of the durable efficacy, tolerability and convenience benefits, we believe that Symproic is a best-in-class PAMORA that reliably provides durable relief of OIC, which frees both the patient and the healthcare provider to focus on treating the patient’s chronic pain.

We believe that there are long-term growth opportunities for Symproic. ~~In 2018, according~~According to data from Symphony Health, in 2019 Symproic prescription volume grew over 60%, capturing 10% of the PAMORA market. In 2019 the PAMORA market ~~for PAMORAs included~~declined by 3%, with over ~~550,000~~585,000 PAMORA prescriptions dispensed. ~~This represents a 1% growth in prescription volume from 2017.~~ The growth rate of the PAMORAs has slowed, ~~since 2017,~~ driven by a decline in opioid prescription rates. As of January 2020, Symproic had formulary coverage for more than 95% of commercial lives.

The risks to our company associated with Symproic include: (i) unexpected product safety issues; (ii) inability to continue to supply product in adequate quantities to meet the commercial demand; (iii) inability to manufacture adequate supplies for commercial use; (iv) failure of our sales force to effectively sell the product and, (v) inadequate reimbursement.

BUNAVAIL

In June 2014, BUNAVAIL (buprenorphine and naloxone buccal film) was approved by the FDA for the maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

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BUNAVAIL contains the partial opioid agonist buprenorphine, which binds to the same receptors as opiate drugs but has a

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higher affinity, and naloxone, an opioid antagonist and an abuse deterrent.

~~BUNAVAIL provides an alternative treatment utilizing the advanced BEMA drug delivery technology. BUNAVAIL has approximately twice the bioavailability of sublingual buprenorphine-containing products~~ In March 2020, we announced that we are discontinuing marketing for ~~opioid dependence, allowing for effective treatment with half the dose when compared to Suboxone film. Additionally,~~ BUNAVAIL offers convenient and discrete buccal administration and avoids the need for patients to avoid talking and swallowing during administration. BUNAVAIL has demonstrated an excellent tolerability profile, with a 68% reduction in the ~~incidence of constipation at the end of 12 weeks~~U.S. in a Phase 3 trial in patients converted from Suboxone sublingual tablets or film to BUNAVAIL. The impact of a growing generic Suboxone market has resulted in declining market conditions, and as such, BUNAVAIL is no longer a core strategic asset for our Company.2020.

ONSOLIS

In July 2009, ONSOLIS (fentanyl buccal soluble film) was approved for the management of pain that “breaks through” the effects of other medications being used to control persistent pain, or breakthrough pain, in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. We refer to breakthrough pain in opioid tolerant patients with cancer as BTCP. ONSOLIS provides significant reduction in pain for patients suffering from BTCP in a convenient formulation with a range of doses to allow patients to titrate to an adequate level of pain control. We are not currently assessing options for U.S. commercialization of ONSOLIS. Given current declining market conditions, we have no plans to introduce the product in the USU.S. at this time. The product is no longer a strategic asset for the Company.

We will continue to seek additional license agreements. We anticipate that funding for the next several years will come primarily from earnings from sales of BELBUCA and Symproic, and milestone payments and royalties from Mylan and TTY.

Results of Operations

Comparison of the three months ended ~~September 30,~~March 31, 2020 and 2019 ~~and 2018~~

Product Sales. We recognized ~~$29.6~~$37.7 million and ~~$13.8~~$19.8 million in product sales during the three months ended ~~September 30,~~March 31, 2020 and 2019, ~~and 2018,~~ respectively. The increase in ~~2019~~2020 is principally due to increased BELBUCA product sales from higher patient utilization, the ~~utilization~~impact of managed care wins, along with a price increase taken on January 1, 2020, and the acquisition of Symproic, offset by lower BUNAVAIL product sales.

Product Royalty Revenues. We recognized ~~$0.7~~$0.6 million in PAINKYL ~~product royalty revenue during the three months ended September 30, 2019 under our license agreement with TTY. We recognized $0.4 million in~~and BREAKYL product royalty revenue during the three months ended ~~September 30, 2018,~~March 31, 2020 under our license ~~agreement~~agreements with ~~Meda.~~TTY and Mylan, respectively. We recognized $0.002 million in product royalty revenue during the three months ended March 31, 2019, under agreements related to previous research and development contracts. Product royalty revenue related to PAINKYL and BREAKYL is primarily via government demand in the Ex-U.S. countries where the products are sold by TTY and Mylan, respectively.

Contract Revenues. We recognized ~~$0.02~~$0.008 million in contract revenues during the three months ended ~~September 30, 2018~~March 31, 2019 related to our license agreements ~~with Purdue Canada (“Purdue”) and~~ TTY. There ~~was~~were no such contract revenues during the same period of ~~2019.~~2020.

Cost of Sales. We incurred ~~$5.4~~$5.6 million and ~~$3.8~~$4.1 million in cost of sales during the three months ended ~~September 30,~~March 31, 2020 and 2019, ~~and 2018,~~ respectively. Cost of sales includes product cost, royalties paid, depreciation, yield adjustments and quarterly minimum royalty payments to CDC IV, LLC (“CDC”).

Selling, General and Administrative Expenses. During the three months ended ~~September 30,~~March 31, 2020 and 2019, ~~and 2018,~~ selling, general and administrative expenses totaled ~~$23.4~~$26.7 million and ~~$13.5~~$17.0 million, respectively. Selling, general and administrative costs include commercialization costs for BELBUCA, BUNAVAIL and Symproic, legal, accounting and management wages, consulting and professional fees, travel costs, stock based compensation and amortization. The increase in selling, general and administrative expenses during the three months ended ~~September 30, 2019~~March 31, 2020 is due to the increase in compensation expense related to our expansion efforts and increased marketing ~~efforts and expenses related to the acquisition of Symproic.~~efforts.

~~Research and Development.~~ We recognized $0.7 million of research and development expense during the three months ended September 30, 2018 related to allocated wages and compensation to approved products and product candidates. There was no such research and development expense during the three months ended September 30, 2019 due to the Company focusing entirely on commercialization of products beginning in 2019.

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Interest expense, net. During the three months ended ~~September 30, 2019,~~March 31, 2020, we had net interest expense of ~~$1.2~~$1.3 million, which includes interest expense of ~~$1.5~~$1.4 million and $0.06 million of amortization of discount and loan ~~costs, both related to~~costs. During the ~~new debt arrangement.~~three months ended March 31, 2020, we also had interest income of $0.2 million.

During the three months ended ~~September 30,~~March 31, 2019, ~~we also had interest income of $0.3 million.~~

~~During the three months ended September 30, 2018,~~ we had net interest expense of $2.6 million, consisting of ~~$1.4~~$1.9 million of scheduled interest payments ~~$0.9~~and $0.6 million of related amortization of ~~discount~~loan discounts and ~~loan~~deferred finance costs ~~and $0.3 million of warrant interest expense, all~~ related to the ~~former debt arrangement.~~February 2017 term loan agreement from CRG.

~~Comparison~~Trends and Uncertainties

Potential Impact of the ~~nine months ended September 30, 2019 and 2018~~

~~Product Sales~~. We recognized $77.4 million and $34.4 million in product sales during the nine months ended September 30, 2019 and 2018, respectively. The increase in 2019 is principally due to increased BELBUCA product sales from the utilization of managed care wins and the acquisition of Symproic, offset by lower BUNAVAIL product sales.

~~Product Royalty Revenues~~. We recognized $2.2 million in product royalty revenue during each of the nine months ended September 30, 2019 and 2018, respectively. Of the aforementioned amounts, $1.0 million and $1.3 million, respectively, can be attributed to royalty revenue from BREAKYL under our license agreement with Meda. We recognized $1.2 million and $0.9 million during the nine months ended September 30, 2019 and 2018, respectively, in PAINKYL royalty revenue under our license agreement with TTY.

~~Contract Revenues~~. We recognized $0.2 million in PAINKYL contract revenue during the nine months ended September 30, 2019 under our license agreement with TTY. We recognized $1.0 million in contract revenue during the nine months ended September 30, 2018 related to our former license agreement with Purdue, which was for the Canadian commercial launch and related milestones.

~~Cost of Sales~~. We incurred $14.3 million and $11.8 million in cost of sales during the nine months ended September 30, 2019 and 2018, respectively. Cost of sales includes product cost, royalties paid, depreciation, yield adjustments and quarterly minimum royalty payments to CDC.

~~Selling,GeneralandAdministrativeExpenses~~. During the nine months ended September 30, 2019 and 2018, selling, general and administrative expenses totaled $62.3 million and $41.0 million, respectively. Selling, general and administrative costs include commercialization costs for BELBUCA, BUNAVAIL and Symproic, management wages and stock-based compensation, legal, accounting and other professional fees, travel costs, and the amortization of our intangible assets including the license and distribution rights from the reacquisition of BELBUCA and the acquisition of Symproic. During the normal course of business, we accrue additional expenses for certain legal matters from time to time, including legal matters related to the protection and enforcement of our intellectual property. The amounts accrued for such legal matters are recorded within accrued expenses on the balance sheet. The increase in selling, general and administrative expenses during 2019 is due to the increase in compensation expense related to our expansion efforts, increased marketing efforts and expenses related to the acquisition of Symproic.

~~Research and Development.~~ We recognized $4.0 million of research and development expense during the nine months ended September 30, 2018 related to allocated wages and compensation to approved products and product candidates. There was no such research and development expense during the nine months ended September 30, 2019 due to the Company focusing entirely on commercialization of products beginning in 2019.

~~Interest expense, net~~. During the nine months ended September 30, 2019, we had net interest expense of $17.7 million, consisting of $11.9 million of one-time costs associated with the refinancing of our debt, $5.3 million of scheduled interest payments relating to both loans, $0.1 million of related amortization of discount and loan costs for both the old and new debt arrangements, and $0.4 million of warrant interest expense associated with the former CRG loan.

The one-time expenses related to the payoff of the CRG loan consisted of $5.2 million in unamortized deferred loan fees, $3.9 million in unamortized warrant discount costs and $2.8 million in loan prepayment fees and realized losses, for a cumulative total of $11.9 million in one-time costs.

~~During the nine months ended September 30, 2019, we also had interest income of $0.6 million.~~

COVID-19 Pandemic

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~~During~~In December 2019, a strain of novel coronavirus (now commonly known as COVID-19) was reported to have surfaced in Wuhan, China. COVID-19 has since spread rapidly throughout many countries, and, on March 12, 2020, the ~~nine months ended September 30, 2018, we~~World Health Organization declared COVID-19 to be a global pandemic. In an effort to contain and mitigate the spread of COVID-19, many countries, including the U.S., have imposed unprecedented restrictions on travel and businesses, and there have been business closures and a substantial reduction in economic activity in countries that have had ~~net interest expense~~significant outbreaks of ~~$7.6 million, consisting~~COVID-19.

COVID-19 may have a material adverse impact on our results of ~~$4.6 million of scheduled interest payments, $2.2 million of related amortization of discount and loan~~operations, including, but not limited to, product sales, revenue, costs, and ~~$0.8 million of warrant interest expense, all related~~product supply. However, significant uncertainty remains as to the ~~former debt arrangement.~~

~~Revenues~~

~~The following table summarizes net product sales~~potential impact of the COVID-19 pandemic on our operations, and on the global economy as a whole. It is currently not possible to predict how long the pandemic will last or the time that it will take for economic activity to return to prior levels. We do not yet know the ~~three~~full extent of any impact on our business or our operations, however, we will continue to monitor the COVID-19 situation closely and ~~nine month periods ended September 30 in thousands:~~

Three months ended September 30, Nine months ended September 30,
2019 2018 2019 2018
BELBUCA $ 26,514 $ 12,358 $ 69,277 $ 30,128
% of net product sales 90 % 90 % 89 % 88 %
Symproic 2,172 — 5,348 —
% of net product sales 7 % — % 7 % — %
BUNAVAIL 937 1,405 2,813 4,239
% of net product sales 3 % 10 % 4 % 12 %
Net product sales $ 29,623 $ 13,763 $ 77,438 $ 34,367
intend to follow health and safety guidelines as they evolve.

Non-GAAP Financial Information:

We report our condensed consolidated financial results in accordance with GAAP; however, we believe that earnings before interest, taxes, depreciation and amortization (“EBITDA”) and other non-GAAP results should not be considered in isolation of or as an alternative for, earnings measures prepared in accordance with GAAP. Management uses these non-GAAP measures internally to measure the ongoing operating performance of our Company along with other metrics, and for planning and forecasting purposes. In addition, when evaluating non-GAAP results, we exclude certain items that are considered to be non-cash and if applicable, non-recurring, in nature.

EBITDA and Non-GAAP Income/(Loss):

We have presented EBITDA because it is a key measure used by our management and board of directors to understand and evaluate our operating performance and to develop operational goals for managing our business. We believe this financial measure helps identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude. In particular, we believe that the exclusion of the expenses eliminated in calculating EBITDA can provide a useful measure for period-to-period comparisons of our core operating performance. Accordingly, we believe that EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

EBITDA is not prepared in accordance with GAAP, and should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of adjusted EBITDA rather than net income/(loss), which is the nearest GAAP equivalent. Some of these limitations are:

•EBITDA excludes depreciation and amortization and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in EBITDA;

•EBITDA does not reflect provision for (benefit from) income taxes or the cash requirements to pay taxes; and

•EBITDA excludes net interest, including both interest expense and interest income.

Non-GAAP net income/(loss) is an alternative view of our performance that we are providing because management believes this information enhances investors’ understanding of our results as it permits investors to better understand the ongoing operations of the business, the impact of any non-recurring one-time events, the cash results of the organization and is an additional measure used by management to assess performance.

Non-GAAP net income/(loss) is not prepared in accordance with GAAP, and should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of non-GAAP net income/(loss) rather than net income/(loss), which is the nearest GAAP equivalent. Some of these limitations are:

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•Non-GAAP income/(loss) excludes certain one-time items because of the nature of the items and the impact that those have on the analysis of underlying business performance and trends. Specifically, in the presentation of non-GAAP income/(loss) for the nine months periods September 30, 2019, we have excluded the financial impact of our debt refinancing which closed in May 2019, as it is non-recurring. This excluded item is a significant component in understanding and assessing ongoing financial performance. The one-time expenses related to the payoff of the CRG loan consisted of $5.2 million in unamortized deferred loan fees, $3.9 million in unamortized warrant discount costs and $2.8 million in loan prepayment fees and realized losses, for a cumulative total of $11.9 million in one-time costs;

•The expenses and other items that we exclude in our calculation of non-GAAP net income/(loss) may differ from the expenses and other items, if any, that other companies may exclude from non-GAAP net income/(loss) when they report their operating results since non-GAAP income/(loss) is not a measure determined in accordance with GAAP, and it has no standardized meaning prescribed by GAAP;

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•We exclude stock-based compensation expense from non-GAAP net income/(loss) although (a) it has been, and will likely continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy and (b) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would likely be higher, which would affect our cash position;

•We exclude amortization of intangible assets from non-GAAP net income/(loss) due to the non-cash nature of this expense and although it has been and will continue to be for the foreseeable future a recurring expense for our business, these expenses do not affect our cash position; and

•~~Amortization of warrant discount costs associated with the CRG loan which was dissolved in May 2019 are excluded given these expenses did not affect our cash position;~~

Reconciliations of non-GAAP metrics to most directly comparable U.S. GAAP financial measures:

The following tables reconcile net income/(loss)earnings and computations (in thousands) under GAAP to a Non-GAAP basis.

Three Months Ended
September 30, Nine Months Ended
September 30,
Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP) 2019 2018 2019 2018
GAAP net income/(loss) $ 354 $ (6,380) $ (14,609) $ (26,859)
Add back:
Provision for income taxes 4 — 4 53
Net interest expense 1,237 2,569 17,727 7,606
Depreciation and amortization 1,904 1,519 5,259 4,718
EBITDA $ 3,499 $ (2,292) $ 8,381 $ (14,482)
Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)
GAAP net income/(loss) 354 (6,380) (14,609) (26,859)
Non-GAAP adjustments:
Stock-based compensation expense 1,267 892 3,978 4,896
Amortization of intangible assets 1,898 1,289 5,084 3,868
Amortization of warrant discount — 269 448 807
Non-recurring financial impact of debt refinance — — 11,866 —
Non-GAAP net income/(loss) $ 3,519 $ (3,930) $ 6,767 $ (17,288)


	Three Months Ended March 31,
Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP)	2020		2019
GAAP net income/(loss)	$	4,966	$	(3,833)
Add back:
Provision for income taxes	(278)		—
Net interest expense	1,294		2,561
Depreciation and amortization	1,802		1,375
EBITDA	$	7,784	$	103
Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)
GAAP net income/(loss)	4,966		(3,833)
Non-GAAP adjustments:
Stock-based compensation expense	1,520		1,142
Amortization of intangible assets	1,781		1,289
Amortization of warrant discount	—		269
Non-GAAP net income/(loss)	$	8,267	$	(1,133)

Liquidity and Capital Resources

Since inception, we have financed our operations principally from the sale of equity securities, proceeds from borrowings, convertible notes, and notes payable, funded research arrangements, revenue generated as a result of our worldwide license and development agreements and the commercialization of our BELBUCA, Symproic and BUNAVAIL products. We

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intend to finance our commercialization and working capital needs from existing cash, earnings from the commercialization of BELBUCA ~~Symproic~~ and ~~BUNAVAIL,~~Symproic, royalty revenue, new sources of debt and equity financing, existing and new licensing and commercial partnership agreements and, potentially, through the exercise of outstanding common stock options and warrants to purchase common stock.

At ~~September 30, 2019,~~March 31, 2020, we had cash and cash equivalents of approximately ~~$55.9~~$70.6 million. We ~~used $5.8~~generated $6.4 million of cash in operations during the ~~nine~~three months ended ~~September 30, 2019.~~March 31, 2020. We believe that we have sufficient cash to manage the business as currently planned.

Additional capital may be required to support the continued commercialization of our BELBUCA and Symproic ~~and BUNAVAIL~~ products, ~~as well as~~or other products which may be acquired or licensed by us, and for general working capital requirements. Based on ~~product development timelines and~~ agreements with our partners, the ability to scale up or reduce personnel and associated costs are factors considered throughout the product life cycle. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. ~~Additional funding, capital or loans (including, without limitation, milestone or other payments from commercialization agreements) may be unavailable on favorable terms, if at all.~~

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Accordingly, we anticipate that we may be required to raise additional capital, which may be available to us through a variety of sources, including:

•public equity markets;

•private equity financings;

•commercialization agreements and collaborative arrangements;

•sale of product royalty;

•grants and new license revenues;

•bank loans;

•equipment financing;

•public or private debt; and

•exercise of existing warrants and options.

Readers are cautioned that additional funding, capital or loans (including, without limitation, milestone or other payments from commercialization agreements) may be unavailable on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain technologies and drug formulations or potential markets, either of which could have a material adverse effect on us, our financial condition and our results of operations in ~~2019~~2020 and beyond. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in ownership dilution to existing stockholders.

Contractual Obligations and Commercial Commitments

Our contractual obligations as of ~~September 30, 2019~~March 31, 2020 are as follows in thousands:


		Payments Due by Period																			Payments Due by Period
		Total		Less than 1 year		1-3 years		3-5 years		More than 5 years			Total		Less than 1 year		1-3 years		3-5 years		More than 5 years
Lease obligations	Lease obligations	$	1,038	$	267	$	740	$	31	$	—	Lease obligations	$	861	$	363	$	498	$	—	$	—
Secured loan facility	Secured loan facility	60,000		—		4,615		55,385		—		Secured loan facility	60,000		—		4,615		55,385		—
Interest on secured loan facility	Interest on secured loan facility	25,440		5,997		11,846		7,597		—		Interest on secured loan facility	21,684		5,779		10,893		5,012		—
Minimum royalty expenses*	Minimum royalty expenses*	11,625		1,500		3,000		3,000		4,125		Minimum royalty expenses*	10,875		1,500		3,000		3,000		3,375
Purchase obligations**	Purchase obligations**	1,885		1,363		522		—		—		Purchase obligations**	1,026		872		154		—		—
Total contractual cash obligations	Total contractual cash obligations	$	99,988	$	9,127	$	20,723	$	66,013	$	4,125	Total contractual cash obligations	$	94,446	$	8,514	$	19,160	$	63,397	$	3,375

* Minimum royalty expenses represent a contractual floor that we are obligated to pay CDC and NB Athyrium LLC regardless of actual sales. The minimum payment is $0.4 million per quarter or $1.5 million per year until patent expiry on July 23, 2027.

** Purchase obligations represent an agreement for the supply of active pharmaceutical ingredient for use in production.

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Off-Balance Sheet Arrangements

As of ~~September 30, 2019,~~March 31, 2020, we had no off-balance sheet arrangements.

Effects of Inflation

We do not believe that inflation has had a material effect on our financial position or results of operations. However, there can be no assurance that our business will not be affected by inflation in the future.

Critical Accounting Policies

For information regarding our critical accounting policies and estimates, please refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates” contained in our annual report on Form 10-K for the year ended December 31, ~~2018~~2019 (the ~~“2018~~“2019 Annual Report”).

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

Interest rate risk

Our cash includes all highly liquid investments with an original maturity of three months or less. Because of the short-term maturities of our cash, we do not believe that an increase in market rates would have a significant impact on the realized value of our investments. We place our cash on deposit with financial institutions in the U.S. The Federal Deposit Insurance Corporation covers $0.25 million for substantially all depository accounts. As of March 31, 2020, we had approximately $70.6 million, which exceeded these insured limits.

Foreign currency exchange risk

We currently have, and may in the future have increased, commercial, manufacturing and clinical agreements which are denominated in Euros or other foreign currencies. As a result, our financial results could be affected by factors such as a change in the foreign currency exchange rate between the U.S. dollar or Euro or other applicable currencies, or by weak economic conditions in Europe or elsewhere in the world. Such amounts are currently immaterial to our financial position or results of operations. We are not currently engaged in any foreign currency hedging activities.

Market Risk

We do not engage in speculative transactions nor do we hold or issue financial instruments for trading purposes. In connection with the recapitalization of our business, we have entered into a secured credit facility consisting of a term loan. Our term loan note bears interest which includes fluctuating interest rates based on LIBOR.

There is currently uncertainty around whether LIBOR will continue to exist after 2021. IfHowever, if LIBOR ceases to exist, we ~~may need~~will not be required to renegotiate our loan documents ~~and we cannot predict what alternative index would be negotiated~~ with our lenders. As a result, our interest expense could increase, in which event we may have difficulties making interest payments and funding our other fixed costs, and our available cash flow for general corporate requirements may be adversely affected.

Our fixed rate debt exposes our Company to changes in market interest rates reflected in the fair value of the debt and to the risk that we may need to refinance maturing debt with new debt at a higher rate.current lender.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Quarterly Report, our management, with the participation of our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer) (the “Certifying Officers”), conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the term “disclosure controls and procedures” means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including the Certifying Officers, to allow timely decisions regarding required disclosures.

Readers are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any control

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design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.

Based on this evaluation, the Certifying Officers have concluded that our disclosure controls and procedures were effective as of ~~September 30, 2019.~~March 31, 2020.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during our ~~third~~first quarter of ~~2019~~2020 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS

Certain information set forth in this Quarterly Report on Form 10-Q, including in Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” (and the “Liquidity and Capital Resources” section thereof) and elsewhere may address or relate to future events and expectations and as such constitutes “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to our plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans” or similar expressions. These statements are based upon the current beliefs and expectations of our management and are subject to significant risks and uncertainties, including those detailed in our filings with the SEC. Actual results, including, without limitation: (i) actual sales results (including the results of our continuing commercial efforts with BELBUCA, Symproic and BUNAVAIL), (ii) the application and availability of corporate funds and our need for future funds, (iii) the timing for completion, and results of, scheduled or additional clinical trials and the FDA’s review and/or approval and commercial activities for our products and product candidates and regulatory filings related to the same or (iv) the results of our ongoing intellectual property litigations and patent office proceedings, may differ significantly from those set forth or anticipated in the forward-looking statements. Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and to vary significantly from reporting period to reporting period. Such factors include, among others, the impact of COVID-19 on our business and results of operations, those listed under Item 1A of our ~~2018~~most recent Annual Report on Form 10-K filed with the SEC on March 12, 2020 and under Item 1A of this Quarterly Report on Form 10-Q and other factors detailed from time to time in our other filings with the SEC. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations expressed in this Quarterly Report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings.

See Note 11, Commitments and Contingencies, to our condensed consolidated financial statements included in Part I, Item I of this Quarterly Report on Form 10-Q, which is incorporated into this item by reference.

Item 1A. Risk Factors.

COVID-19 may materially and adversely affect our business and our financial results.

The recent COVID-19 pandemic is understood to have originated in Wuhan, China in December 2019 and has since spread globally, including to the United States and European countries. The continued spread of COVID-19 could adversely impact our operations, including our efforts to market BELBUCA and Symproic. Any decrease in sales or interruption in supply of any of our products could increase our operating expenses and have a material adverse effect on our business and financial results.

In addition, COVID-19 has resulted in significant governmental measures being implemented to control the spread of the virus, including quarantines, travel restrictions, social distancing and business shutdowns. We have taken temporary precautionary measures intended to help minimize the risk of the virus to our employees, including temporarily requiring all employees to work remotely. We have already suspended non-essential travel worldwide for our employees and are ~~dependent~~discouraging employee attendance at other gatherings. These measures could negatively affect our business. For instance, temporarily requiring all employees to work remotely may induce absenteeism, disrupt our operations or increase the risk of a cybersecurity incident. COVID-19 has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which may negatively affect our ability to raise additional capital on attractive terms or at all.

The extent to which COVID-19 may impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, the severity of COVID-19 or the effectiveness of actions to contain and treat COVID-19, particularly in the geographies where we or our third party suppliers ~~for key components~~and contract manufacturers or contract research organizations operate. We cannot presently predict the scope and severity of any potential business shutdowns or disruptions. If we or any of the third parties with whom we engage, however, were to experience shutdowns or other business disruptions, our ~~delivery technologies, products~~ability to conduct our business in the manner and ~~product candidates.~~

Key components of our drug delivery technologies, products and product candidates, including for BELBUCA, Symproic and BUNAVAIL, may be provided by sole or limited numbers of suppliers, and supply shortages or loss of these suppliers could result in interruptions in supply or increased costs. Certain components used in our development activities, such ason the active pharmaceutical ingredients, or API, of our products, are currently purchased from a single or a limited number of outside sources. The reliance on a sole or limited number of suppliers could result in:

•~~delays associated with development and non-clinical and clinical trials due to an inability to timely obtain a single or limited source component;~~

•~~inability to timely obtain a sufficient quantities of API and an adequate supply of required components; and~~

•~~reduced control over pricing, quality and timely delivery.~~

timelines presently

3026

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Our relationships with our manufacturers and suppliers are particularly important to us and any loss of or material diminution of their capabilities due to factors such as regulatory issues, accidents, acts of God or any other factor would have a material adverse effect on our company. Any loss of or interruption in the supply of components from our suppliers or other third-party suppliers would require us to seek alternative sources of supply or require us to manufacture these components internally, which we are currently not able to do.

If the supply of any components is lost or interrupted, API, product or components from alternative suppliers may not be available in sufficient quality or in volumes within required time frames, if at all, to meet our or our partners’ needs. This could delay our ability to complete clinical trials, obtain approval for commercialization or commence marketing or cause us to lose sales, force us into breach of other agreements, incur additional costs, delay new product introductions or harm our reputation. Furthermore, product or components from a new supplier may not be identical to those provided by the original supplier. Such differences could have material effects on our overall business plan and timing, could fall outside of regulatory requirements, affect product formulations or the safety and effectiveness of our products that are being developed.

If our competitors are successful in obtaining approval for Abbreviated New Drug Applications for products that have the same active ingredients as BELBUCA, Symproic or BUNAVAIL, sales of BELBUCA, Symproic or BUNAVAIL may be adversely affected.

Our competitors may submit for approval certain Abbreviated New Drug Applications, or ANDAs, which provide for the marketing of a drug product that has the same active ingredients in the same strengths and dosage form as a drug product already listed with the FDA, and which has been shown to be bioequivalent to such FDA-listed drug. Drugs approved in this way are commonly referred to as generic versions of a listed drug and can often be substituted by pharmacists under prescriptions written for an original listed drug. Any applicant filing an ANDA is required to make patent certifications to the FDA, such as certification to the FDA that the new product subject to the ANDA will not infringe an already approved product’s listed patents or that such patents are invalid (otherwise known as a Paragraph IV Certification).

In February 2016, we announced that a generic competitor, Teva Pharmaceutical Industries Ltd., or Teva, had filed a Paragraph IV Certification challenging certain of our BUNAVAIL-related patents and we received notices regarding Paragraph IV certifications from Teva in November and December 2016, seeking to find invalid two Orange Book listed patents relating specifically to BELBUCA. The filing of this certification required us to initiate costly litigation against Teva. In addition, a number of our competitor companies have filed Paragraph IV Certifications challenging the patent for Suboxone® film, the market leader in the field in which we are seeking to generate sales of BUNAVAIL. To the extent that any company is successful in challenging the validity of certain patents covering BUNAVAIL or Suboxone® ~~film under a Paragraph IV Certification, it could result in FDA approval of a drug that is lower in price to BUNAVAIL or Suboxone~~® film. Such a new drug could make it more difficult for BUNAVAIL to gain any significant market share in an increasingly generic marketplace, which would have a material adverse effect on our results of operations, cash flow, reputation and stock price.

In October 2017, we announced that we had entered into a settlement agreement with Teva that resolved our BUNAVAIL patent litigation against Teva pending in the U.S. District Court for the District of Delaware. As part of the Settlement Agreement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, we entered into a non-exclusive license agreement with Teva that permits Teva to first begin selling its generic version of BUNAVAIL in the U.S. on July 23, 2028 or earlier under certain circumstances. Other terms of the agreement are confidential.

In February 2018, we announced that we had entered into a Settlement Agreement with Teva that resolves our previously reported BELBUCA, patent litigation against Teva pending in the United States District Court for the District of Delaware. As part of the settlement agreement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, we entered into a non-exclusive license agreement with Teva that permits Teva to first begin selling its generic version of BELBUCA in the U.S. on January 23, 2027 or earlier under certain circumstances. Other terms of the agreement are confidential.

~~As such, we have been and may continue to be subject to ANDA-related litigation, which is costly and distracting and has the potential to impair the long-term value of our products.~~

We are presently a party to lawsuits by third parties who claim that our products, methods of manufacture or methods of use infringe on their intellectual property rights, and we may be exposed to these types of claims in the future.

We are presently, and may continue to be, exposed to litigation by third parties based on claims that our technologies, processes, formulations, methods, or products infringe the intellectual property rights of others or that we have misappropriated the trade secrets of others. This risk is exacerbated by the fact that the validity and breadth of claims covered in pharmaceutical

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patents is, in most instances, uncertain and highly complex. Any litigation or claims against us, whether or not valid, would result in substantial costs, could place a significant strain on our financial and human resources and could harm our reputation. Such a situation may force us to do one or more of the following:

•~~incur significant costs in legal expenses for defending against an intellectual property infringement suit;~~

•delay the launch of, or cease selling, making, importing, incorporating or using one or more or all of our technologies and/or formulations or products that incorporate the challenged intellectual property, which would adversely affect our revenue;

•~~obtain a license from the holder of the infringed intellectual property right, which license may be costly or may not be available on reasonable terms, if at all; or~~

•~~redesign our formulations or products, which would be costly and time-consuming.~~

With respect to our BEMA delivery technology, the thin film drug delivery technology space is highly competitive. There is a risk that a court of law in the United States or elsewhere could determine that one or more of our BEMA based products conflicts with or covered by external patents. This risk presently exists in our litigation with Reckitt Benckiser, Inc., RB Pharmaceuticals Limited, and Aquestive Therapeutics, Inc. (formerly known as MonoSol Rx LLC, or Aquestive) relating to our BUNAVAIL product which was filed in September 2014 and in our litigation with Aquestive relating to our BELBUCA product which was filed in January 2017. If the courts in these cases were to rule against us and our partner in these cases, weplanned could be ~~forced to license technology from Aquestive or be prevented from marketing BUNAVAIL or BELBUCA, or otherwise incur liability for damages,~~materially and negatively affected, which could have a material adverse ~~effect~~impact on our ~~ability for us or~~business and our ~~partners to market~~results of operations and ~~sell BUNAVAIL or BELBUCA.~~

We have been granted non-exclusive license rights to European Patent No. 949 925, which is controlled by LTS to market BELBUCA and ONSOLIS within the countries of the European Union. We are required to pay a low single digit royalty on sales of products that are covered by this patent in the European Union. We have not conducted freedom to operate searches and analyses for our other proposed products. Moreover, the possibility exists that a patent could issue that would cover one or more of our products, requiring us to defend a patent infringement suit or necessitating a patent validity challenge that would be costly, time consuming and possibly unsuccessful.

Our lawsuits with Aquestive and RB Pharmaceuticals have caused us to incur significant legal costs to defend ourselves, and we would be subject to similar costs if we are a party to similar lawsuits in the future. Furthermore, if a court were to determine that we infringe any other patents and that such patents are valid, we might be required to seek one or more licenses to commercialize our BEMA products. We may be unable to obtain such licenses from the patent holders, which could materially and adversely impact our business.financial condition.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

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Item 6. Exhibits.


Number	Description


31.1		Certification of Principal Executive Officer Pursuant To Sarbanes-Oxley Section 302. *

31.2		Certification of Principal Financial Officer Pursuant To Sarbanes-Oxley Section 302. *

32.1		Certification Pursuant To 18 U.S.C. Section 1350. #

32.2		Certification Pursuant To 18 U.S.C. Section 1350. #

101.ins	XBRL Instance Document.

101.sch	XBRL Taxonomy Extension Schema Document.

101.cal	XBRL Taxonomy Calculation Linkbase Document.

101.def	XBRL Taxonomy Definition Linkbase Document.

101.lab	XBRL Taxonomy Label Linkbase Document.

101.pre	XBRL Taxonomy Presentation Linkbase Document.

*Filed herewith, a signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

#This certification will 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 liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.

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SIGNATURES

Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


	BIODELIVERY SCIENCES INTERNATIONAL, INC.

Date: ~~November 12, 2019~~May 7, 2020	By:	/s/ Herm Cukier
		Herm Cukier
		Chief Executive Officer and Director
		(Principal Executive Officer)

Date: ~~November 12, 2019~~May 7, 2020	By:	/s/ Mary Theresa Coelho
		Mary Theresa Coelho
		Treasurer and Chief Financial Officer
		(Principal Financial and Accounting Officer)

S-1


Maturity of Lease Liabilities
2019	$	89
2020	360
2021	370
2022	219
Total lease payments	$	1,038
Less: Interest	(152)
Present value of lease liabilities	$	886


	Number of restricted shares	Weighted average fair market value per RSU
Outstanding at January 1, 2019	2,166,102	$	2.59
Granted:
Executive officers	223,250	4.44
Directors	90,000	4.85
Employees	47,000	4.67
Vested	(801,661)	4.80
Forfeitures	(87,132)	2.30
Outstanding at September 30, 2019	1,637,559	$	3.23


	Three Months Ended September 30,						Nine Months Ended September 30,
Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP)	2019		2018		2019		2018
GAAP net income/(loss)	$	354	$	(6,380)	$	(14,609)	$	(26,859)
Add back:
Provision for income taxes	4		—		4		53
Net interest expense	1,237		2,569		17,727		7,606
Depreciation and amortization	1,904		1,519		5,259		4,718
EBITDA	$	3,499	$	(2,292)	$	8,381	$	(14,482)
Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)
GAAP net income/(loss)	354		(6,380)		(14,609)		(26,859)
Non-GAAP adjustments:
Stock-based compensation expense	1,267		892		3,978		4,896
Amortization of intangible assets	1,898		1,289		5,084		3,868
Amortization of warrant discount	—		269		448		807
Non-recurring financial impact of debt refinance	—		—		11,866		—
Non-GAAP net income/(loss)	$	3,519	$	(3,930)	$	6,767	$	(17,288)