BDSI BioDelivery Sciences International Inc

BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions, today reported strong financial results for the second quarter ended June 30, 2019, as well as the following operational and performance highlights:

Key Business Highlights

• Total company net revenue increased by 144% versus the prior year period to a new all-time high of $29.7 million.  This growth was driven by BELBUCA® (buprenorphine buccal film), CIII sales of $24.1 million, an increase of 147% versus the prior year period, and the addition of Symproic® (naldemedine) tablets 0.2 mg to the commercial portfolio. 
• Total BELBUCA prescriptions of more than 80,000 for the quarter was the highest ever for any three-month period.  In addition, prescription growth for BELBUCA reached an all-time year-over-year record increase of 44,560 prescriptions, representing a 125% increase year-over-year and a 23% increase versus the prior quarter. 
• Achieved a new all-time high of 6,579 unique BELBUCA prescribers during the quarter. 
• Delivered highest ever number of quarterly prescriptions for Symproic achieving greater than 14% quarter-over-quarter growth and 40% growth versus prior year. 
• Significantly strengthened financial position through debt refinancing, dramatically lowering cost of capital and extending maturity.

“The second quarter was highlighted by dramatic accomplishments across our entire organization and has positioned us to further build upon our commercial success,” stated Herm Cukier, Chief Executive Officer of BDSI.  “We have significant momentum with our core products and have strengthened the company’s financial position.  Our excellent performance in the second quarter is the fifth consecutive quarter of sustained and rapid growth.  I believe our future is very promising, and as we raise our full-year BELBUCA and total company net sales expectations for the second time this year, we have great confidence in our growth trajectory into 2020 and beyond.” 

The company again increased its expectations for full-year 2019 BELBUCA net sales to $90 - $93 million, from the previous level of $83 - $88 million.  The company also raised its total 2019 net sales expectations to $101 - $105 million, from the previous level of $92 – $100 million.  Total net revenue expectations include $7 - $9 million of forecasted Symproic net sales, which is in line with the company’s previous expectation.  

With the strong performance achieved over the last five consecutive quarters, coupled with a solid balance sheet supporting the execution of the commercial growth plan, the company is raising its long-term combined net sales expectations for BELBUCA and Symproic to $425 - $500 million.

Second Quarter 2019 Financial Results

Total Net Revenue.  Total net revenue for the second quarter ended June 30, 2019, was $29.7 million, an increase of 50%, compared to $19.8 million in the first quarter of 2019, and an increase of 144%, compared to $12.2 million in the second quarter of 2018.

Total Net Product Sales.  Total net product sales in the second quarter were $28.1 million, an increase of 42%, compared to $19.8 million in the first quarter of 2019 and an increase of 161% compared to $10.8 million in the second quarter of 2018.  This includes net product sales of Symproic of $3.2 million in the initial quarter of commercialization following the acquisition of the product. 

BELBUCA Net Sales. BELBUCA net sales in the second quarter were $24.1 million, an increase of 29%, compared to $18.7 million in the first quarter of 2019 and an increase of 147%, compared to $9.7 million in the second quarter of 2018.

Total Operating Expenses.  Total operating expenses in the quarter ended June 30, 2019, were $22.0 million, compared to $17.0 million in the first quarter of 2019 and $14.9 million in the second quarter of 2018.

GAAP Net Loss.  GAAP net loss for the quarter was $11.1 million, or ($0.13) per share, compared to the loss of $3.8 million, or ($0.05) per share, for the first quarter of 2019 and a GAAP net loss of $9.8 million, or ($0.16) per share, in the second quarter of 2018. The increase in net loss is driven by the one-time debt refinancing costs of $11.9 million.

EBITDA.  EBITDA in the second quarter of 2019 was $4.8 million or 16.1% of total net revenue, compared to $0.1 million in the first quarter of 2019 and ($5.6) million in the second quarter of 2018.

Non-GAAP Net Income.  Non-GAAP net income for the quarter was $4.4 million and reflects GAAP net loss excluding the non-recurring costs of the debt refinancing, stock-based compensation and non-cash amortization of intangible assets and warrant discounts.

Cash Position.  BDSI had cash and cash equivalents of approximately $57.2 million as of June 30, 2019. Based on current guidance, the company anticipates having positive operating cash flow by the fourth quarter of 2019.

Conference Call & Webcast Details

BioDelivery Sciences will host a conference call and webcast today, August 8, 2019, at 4:30 p.m. ET to present second quarter 2019 results and to provide a business update.  Dial-in details are as follows:

Date:	Thursday, August 8, 2019
Time:	4:30 PM EDT
Domestic:	800-347-6311
International:	720-543-0197
Passcode:	868 4665
Webcast:	http://public.viavid.com/index.php?id=135544

ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products and those in development address serious and debilitating conditions such as chronic pain, breakthrough cancer pain, opioid dependence, and opioid-induced constipation.

CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS

This press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the BDSI’s management and are subject to significant risks and uncertainties, including those detailed in the BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the continued growth in BELBUCA net revenues and total net revenues in 2019 and the implementation and success of our Symproic strategic plan) may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the BDSI’s control) including those set forth in our 2019 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

© 2019 BioDelivery Sciences International, Inc.  All rights reserved.

Contact:

Mary ColemanVice President, Investor Relations and Corporate CommunicationsBioDelivery Sciences International, Inc.mcoleman@bdsi.com

	BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
	CONDENSED CONSOLIDATED BALANCE SHEETS
	(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
	(Unaudited)
		June 30,			December 31,
			2019			2018
	ASSETS
	Current assets:
	Cash and cash equivalents	$	57,215		$	43,822
	Accounts receivable, net.		24,879			13,627
	Inventory, net		9,974			5,406
	Prepaid expenses and other current assets		3,298			3,188
	Total current assets		95,366			66,043
	Property and equipment, net		3,853			3,072
	Goodwill		2,715			2,715
	License and distribution rights, net		63,778			36,000
	Other intangible assets, net		375			703
	Total assets	$	166,087		$	108,533
	LIABILITIES AND STOCKHOLDERS' EQUITY
	Current liabilities:
	Accounts payable and accrued liabilities	$	40,762		$	21,539
	Total current liabilities		40,762			21,539
	Notes payable, net		58,448			51,652
	Other long-term liabilities		727			5,600
	Total liabilities		99,937			78,791
	Commitments and contingencies
	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 June 30, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value, 1,716 and 3,100 shares outstanding at June 30, 2019 and December 31, 2018, respectively.		2			2
	Common Stock, $.001 par value; 125,000,000 shares authorized at June 30, 2019 and December 31, 2018, respectively; 89,535,024 and 75,793,725 shares issued;89,519,533 and 70,778,234 shares outstanding at June 30, 2019 and December 31, 2018, respectively.		88			71
	Additional paid-in capital		432,358			381,004
	Treasury stock, at cost, 15,491 shares		(47	)		(47	)
	Accumulated deficit		(366,251	)		(351,288	)
	Total stockholders' equity		66,150			29,742
	Total liabilities and stockholders' equity	$	166,087		$	108,533

 

	BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
	CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
	(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
	(Unaudited)
		Three Months Ended June 30,							Six Months Ended June 30,
			2019			2018				2019			2018
	Revenues:
	Product sales	$	28,056		$	10,766			$	47,815		$	20,604
	Product royalty revenues		1,461			1,386				1,471			1,826
	Contract revenue		160			23				160			1,026
	Total Revenues:		29,677			12,175				49,446			23,456
	Cost of sales		4,923			4,566				8,975			7,981
	Expenses:
	Research and development:		-			854				-			3,338
	Sales, general and administrative		21,955			14,021				38,944			27,526
	Total Expenses:		21,955			14,875				38,944			30,864
	Income (loss) from operations		2,799			(7,266	)			1,527			(15,389	)
	Interest expense		(13,937	)		(2,525	)			(16,498	)		(5,030	)
	Other (expense) income, net		8			1				8			(6	)
	Loss before income taxes	$	(11,130	)	$	(9,790	)		$	(14,963	)	$	(20,425	)
	Income tax benefit (expense)		-			20				-			(54	)
	Net loss attributable to common stockholders	$	(11,130	)	$	(9,770	)		$	(14,963	)	$	(20,479	)
	Basic and diluted
	Weighted average common stock shares outstanding:		83,821,811			59,400,317				77,571,003			58,735,351
	Basic and diluted loss per share:	$	(0.13	)	$	(0.16	)		$	(0.19	)	$	(0.35	)

 

		BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
		CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
		(U.S. DOLLARS, IN THOUSANDS)
		(Unaudited)
				Six Months Ended June 30,
					2018			2018
	Operating activities:
		Net loss		$	(14,963	)	$	(20,479	)
			Depreciation and amortization		168			456
			Impairment loss on equipment		-			78
			Accretion of debt discount and loan costs		11,374			1,782
			Amortization of intangible assets		3,187			2,578
			Provision for inventory obsolescence		149			412
			Stock-based compensation expense		2,711			4,004
		Changes in assets and liabilities, net of effect of acquisition:
			Accounts receivable		(11,252	)		(423	)
			Inventories		(4,716	)		(489	)
			Prepaid expenses and other assets		(110	)		1,454
			Accounts payable and accrued expenses		9,078			(1,118	)
		Net cash flows from operating activities			(4,374	)		(11,745	)
	Investing activities:
			Product acquisitions		(20,674	)		(1,951	)
			Acquisitions of equipment		(79	)		(122	)
		Net cash flows from investing activities			(20,753	)		(2,073	)
	Financing activities:
			Proceeds from issuance of common stock		48,000			-
			Proceeds from issuance of Series B preferred stock		-			50,000
			Equity financing costs		(410	)		(1,509	)
			Proceeds from notes payable		60,000			-
			Proceeds from exercise of stock options		1,070			306
			Payment of notes payable		(67,346	)		-
			Loss on refinancing of former debt		(2,794	)		-
			Payment of deferred financing fees		-			(450	)
		Net cash flows from financing activities			38,520			48,347
	Net change in cash and cash equivalents				13,393			34,529
	Cash and cash equivalents at beginning of year				43,822			21,195
	Cash and cash equivalents at end of year			$	57,215		$	55,724

 

	BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
	RECONCILIATION OF NON-GAAP METRICS
	(U.S. DOLLARS, IN THOUSANDS)
	(Unaudited)
	Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP)		Three Months Ended June 30,							Six Months Ended June 30,
				2019			2018				2019			2018
	GAAP net income/(loss)		$	(11,130	)	$	(9,770	)		$	(14,963	)	$	(20,479	)
	Add back:
	Provision for income taxes			-			(20	)			-			53
	Net interest expense			13,929			2,525				16,490			5,037
	Depreciation and amortization			1,981			1,679				3,356			3,199
	EBITDA		$	4,780		$	(5,586	)		$	4,883		$	(12,190	)
	Reconciliation of GAAP net income/(loss) to non-GAAP net income/(loss)
	GAAP net income/(loss)		$	(11,130	)	$	(9,770	)		$	(14,963	)	$	(20,479	)
	Non-GAAP adjustments:
	Stock-based compensation expense			1,569			1,084				2,712			4,005
	Amortization of intangible assets			1,898			1,289				3,187			2,578
	Amortization of warrant discount			179			269				448			538
	Non-recurring financial impact of debt refinance			11,866			-				11,866			-
	Non-GAAP net income/(loss)		$	4,382		$	(7,128	)		$	3,250		$	(13,358	)