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BioDelivery Sciences Reports Strong Fourth Quarter and Full-Year 2019 Results

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  • BDSI

Full-Year Total Company Net Sales Increased 100% versus Prior Year to $111.4 Million

Full-Year BELBUCA® Net Sales Increased 112% versus Prior Year to $97.5 Million

Fourth Quarter Total Company Net Sales Increased 75% versus Prior Year to $31.6 Million

Fourth Quarter BELBUCA® Net Sales Increased 78% versus Prior Year to $28.3 Million

Conference Call and Webcast Scheduled for 4:30 PM EST Today

RALEIGH, N.C., March 12, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today reported strong financial results for the fourth quarter and full-year ended December 31, 2019, as well as the following operational and performance highlights.

Key Business Highlights

  • Total Company full-year net sales of $111.4 million delivered growth of 100% versus 2018 and was driven by BELBUCA® (buprenorphine buccal film), CIII net sales of $97.5 million, an increase of 112% compared to 2018, and the addition of Symproic® (naldemedine) tablets 0.2mg to the commercial portfolio, which delivered $8.1 million net sales in 2019.

  • Total Company net revenue for the fourth quarter increased by 75% versus the prior year period to a new all-time high of $31.6 million. This growth was driven by BELBUCA sales of $28.3 million, an increase of 78% versus the prior year period, and the addition of Symproic to the commercial portfolio.

  • Total BELBUCA prescriptions of more than 96,000 for the fourth quarter were the highest ever for any three-month period, representing year-over-year prescription volume growth of more than 70% in the quarter.

  • Total Symproic prescriptions reached an all-time high of 16,555 in the fourth quarter, representing more than 36% growth versus the prior year period.

  • Achieved record number of unique prescribers during the quarter for both BELBUCA and Symproic.

  • In addition, as previously released, the Company recently presented the positive results from the BELBUCA Phase I respiratory drive study at the American Academy of Pain Medicine’s (AAPM) 36th Annual Meeting.

“I am very pleased by the continued strong execution during the fourth quarter, culminating in a very successful and transformative year for the Company in 2019,” stated Herm Cukier, CEO of BDSI. “The continued growth of BELBUCA and Symproic, in addition to the commercial and scientific plans we have developed, position us for long-term sustained success. We continue to monitor the COVID-19 pandemic for any potential impact which may arise in this rapidly evolving situation, and remain focused on bringing important clinical value to patients.”

Fourth Quarter 2019 Financial Results

Total Company Net Revenue for the fourth quarter of 2019 was $31.6 million, an increase of 75% compared to $18.0 million in the fourth quarter of 2018, and an increase of 4% compared to $30.3 million in the third quarter of 2019.

BELBUCA Net Sales for the fourth quarter of 2019 were $28.3 million, an increase of 78% compared to $15.9 million in the fourth quarter of 2018, and an increase of 7% compared to $26.5 million in the third quarter of 2019.

Symproic Net Sales for the fourth quarter were $2.7 million, an increase of 25% compared to $2.2 million in the third quarter of 2019.

BUNAVAIL Net Sales for the fourth quarter were ($0.5) million, a reduction of 141.7% compared to $1.2 million in the fourth quarter of 2018. Net sales for the fourth quarter of 2019 reflect $2.3 million of one-time additional revenue related reserves in connection with the March 2020 announcement of the discontinuation of marketing of BUNAVAIL.

Product Royalty Revenue for the fourth quarter was $1.2 million, an increase of $0.2 million compared to $1.0 million in the fourth quarter of 2018 and an increase of $0.5 million compared to the third quarter of 2019.

Total Operating Expenses for the fourth quarter of 2019 were $23.8 million, compared to $23.4 million in the third quarter of 2019 and $18.5 million in the fourth quarter of 2018.

GAAP Net Loss for the fourth quarter of 2019 was $0.7 million compared to GAAP net income of $0.4 million for the third quarter of 2019 and GAAP net loss of $7.0 million in the fourth quarter of 2018.

EBITDA in the fourth quarter of 2019 was $4.1 million, or 13.0% of net sales, compared to $3.5 million in the third quarter of 2019 and ($3.0) million in the fourth quarter of 2018.

Non-GAAP Net Income for the quarter was $6.4 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets, and the non-recurring financial impact of $3.8 million related to the discontinuation of marketing of BUNAVAIL.

Full-Year 2019 Financial Results

Total Net Revenue for full-year 2019 was $111.4 million, an increase of 100% compared to $55.6 million for full-year 2018.

BELBUCA Net Sales for full-year 2019 were $97.5 million, an increase of 112% compared to $46.0 million for full-year 2018.

Symproic Net Sales for full-year 2019 were $8.1 million, reflecting three quarters of sales during 2019.

BUNAVAIL Net Sales for full-year 2019 were $2.3 million, a reduction of 57.4% compared to $5.4 million for full-year 2018.

Product Royalty Revenue for full-year 2019 was $3.5 million, compared to $4.2 million for full-year 2018.

Total Operating Expenses for full-year 2019 were $86.1 million, compared to $63.5 million for full-year 2018.

GAAP Net Loss for full-year 2019 was $15.3 million compared to GAAP net loss of $33.9 million for full-year 2018.

EBITDA for full-year of 2019 was $12.5 million, or 11.2% of net sales compared to ($17.5) million, or (31.4)% of net sales for full-year 2018.

Non-GAAP Net Income for full-year 2019 was $13.2 million and reflects GAAP net income excluding stock-based compensation, non-cash amortization of intangible assets and certain warrant discount costs, one-time expenses related to our debt refinancing in May 2019, and the non-recurring financial impact related to the discontinuation of the marketing of BUNAVAIL.

Cash Position: As of December 31, 2019, cash and cash equivalents were approximately $63.9 million, compared to cash and cash equivalents of $43.8 million as of December 31, 2018, and $55.9 million in the third quarter of 2019, reflecting positive cash flow of $8.0 million in the fourth quarter of 2019, and $20.1 million for full-year 2019.

Conference Call & Webcast Details

BioDelivery Sciences will host a conference call and webcast today, March 12, 2020, at 4:30 p.m. ET to present fourth quarter 2019 results and to provide a business update. Dial-in details are as follows:

Date:

Thursday, March 12, 2020

Time:

4:30 PM EST

Domestic:

877-407-0789

International:

201-689-8562

Conference ID:

13699178

Webcast:

http://public.viavid.com/index.php?id=138131

ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

BioDelivery Sciences International, Inc. (BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products address serious and debilitating conditions, including chronic pain, 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 BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the continued growth in BELBUCA net sales and total company net revenue in 2020 may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI’s control) including the risk that the current coronavirus pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as those set forth in our 2019 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

Non-GAAP Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States, or GAAP, including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

Non-GAAP net income adjusts for one-time and non-cash charges by excluding the following from GAAP net income: stock-based compensation expense, amortization of intangible assets, amortization of certain warrant discount costs, and the financial impact of certain one-time items that are non-recurring, including our debt refinancing in May 2019 and the discontinuation of marketing of BUNAVAIL.

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

The Company's management and board of directors utilize these non-GAAP financial measures to evaluate the Company's performance. The Company provides these non-GAAP measures of the Company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of our liquidity.

A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

© 2020 BioDelivery Sciences International, Inc. All rights reserved.

Contact:

Tirth Patel
Director of Investor Relations
(919) 582-0294
tpatel@bdsi.com


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

December 31,

2019

2018

ASSETS

Current assets:

Cash

$

63,888

$

43,822

Accounts receivable, net

38,790

13,627

Inventory, net

11,312

5,406

Prepaid expenses and other current assets

3,769

3,188

Total current assets

117,759

66,043

Property and equipment, net

2,075

3,072

Goodwill

2,715

2,715

License and distribution rights, net

60,309

36,000

Other intangible assets, net

47

703

Total assets

$

182,905

$

108,533

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$

53,993

$

21,539

Total current liabilities

53,993

21,539

Notes payable, net

58,568

51,652

Other long-term liabilities

580

5,600

Total liabilities

113,141

78,791

Commitments and contingencies

Stockholders’ equity:

Preferred Stock, 5,000,000 shares authorized; 2,714,300 shares issued; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 2,093,155 shares outstanding at both December 31, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 618 and 3,100 shares outstanding at December 31, 2019 and December 31, 2018 respectively.

2

2

Common Stock, $.001 par value; 175,000,000 and 125,000,000 shares authorized at December 31, 2019 and December 31, 2018 respectively; 96,189,074 and 70,793,725 shares issued;96,173,583 and 70,778,234 shares outstanding at December 31, 2019 and December 31, 2018, respectively.

96

71

Additional paid-in capital

436,306

381,004

Treasury stock, at cost, 15,491 shares

(47

)

(47

)

Accumulated deficit

(366,593

)

(351,288

)

Total stockholders’ equity

69,764

29,742

Total liabilities and stockholders’ equity

$

182,905

$

108,533



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

Year Ended December 31,

2019

2018

2017

Revenues:

Product sales

$

107,888

$

51,410

$

34,922

Product royalty revenues

3,341

3,389

5,070

Research and development reimbursements

799

Contract revenue

160

841

21,194

Total revenues

111,389

55,640

61,985

Cost of sales

21,590

15,783

19,496

Expenses:

Research and development

4,903

13,040

Selling, general and administrative

86,063

58,602

58,869

Total expenses

86,063

63,505

71,909

Income (loss) from operations

3,736

(23,648

)

(29,420

)

Interest expense

(19,040

)

(10,192

)

(8,577

)

Bargain purchase gain

27,336

Other income (expense), net

4

(14

)

(26

)

Loss before income taxes

(15,300

)

(33,854

)

(10,687

)

Income tax (expense) benefit

(5

)

(13

)

15,972

Net (loss) income

(15,305

)

(33,867

)

5,285

Beneficial conversion feature of convertible preferred stock

(12,500

)

Net (loss) income attributable to common stockholders

$

(15,305

)

$

(46,367

)

$

5,285

Basic:

Weighted average common stock shares outstanding

83,213,704

63,165,063

55,355,802

Basic (loss) earnings per share

$

(0.18

)

$

(0.73

)

$

0.10

Diluted:

Diluted weighted average common stock shares outstanding

83,213,704

63,165,063

56,402,479

Diluted (loss) earnings per share

$

(0.18

)

$

(0.73

)

$

0.09



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

Year Ended December 31,

2019

2018

2017

Operating activities:

Net (loss) income

$

(15,305

)

$

(33,867

)

$

5,285

Adjustments to reconcile net (loss) income to net cash flows provided by (used in) operating activities

Depreciation

1,846

740

693

Accretion of debt discount and loan costs

11,508

4,138

2,392

Amortization of intangible assets

6,981

5,157

5,425

Provision for (recovery from) inventory obsolescence

197

(56

)

243

Impairment loss on equipment

78

Stock-based compensation expense

5,416

5,941

14,801

Deferred income taxes

40

(15,972

)

Bargain purchase gain

(27,336

)

Changes in assets and liabilities, net of effect of acquisition:

Accounts receivable

(25,163

)

(4,640

)

(5,884

)

Inventories

(6,102

)

741

2,448

Prepaid expenses and other assets

(581

)

422

526

Accounts payable and accrued expenses

32,275

(2,807

)

6,644

Deferred revenue

(21,716

)

Net cash flows provided by (used in) operating activities

11,072

(24,113

)

(32,451

)

Investing activities:

Product acquisitions

(30,685

)

(1,951

)

(5,853

)

Acquisitions of equipment

(79

)

(112

)

(11

)

Net cash flows used in investing activities

(30,764

)

(2,063

)

(5,864

)

Financing activities:

Proceeds from exercise of stock options

2,321

670

439

Proceeds from issuance of common stock, less underwriters discount

48,000

Proceeds from issuance of Series B preferred stock

50,000

Payment on note payable

(67,346

)

(30,000

)

Proceeds from notes payable

59,987

60,000

Equity finance costs

(410

)

(1,417

)

Payment of deferred financing fees

(450

)

(2,948

)

Loss on refinancing of former debt

(2,794

)

Net cash flows provided by financing activities

39,758

48,803

27,491

Net change in cash and cash equivalents

20,066

22,627

(10,824

)

Cash and cash equivalents at beginning of year

43,822

21,195

32,019

Cash and cash equivalents at end of year

$

63,888

$

43,822

$

21,195



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.

Year Ended December 31,

Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP)

2019

2018

2017

GAAP net income/(loss)

$

(15,305

)

$

(33,867

)

$

5,285

Add back:

Provision for income taxes

5

14

(15,972

)

Net interest expense

19,036

10,206

(18,733

)

Depreciation and amortization

8,748

6,188

6,119

EBITDA

$

12,484

$

(17,459

)

$

(23,301

)

Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)

GAAP net income/(loss)

(15,305

)

(33,867

)

5,285

Non-GAAP adjustments:

Stock-based compensation expense

5,416

5,941

14,800

Amortization of intangible assets

6,981

5,157

5,425

Amortization of warrant discount

448

1,076

832

Non-recurring financial impact of debt refinance

11,866

Non-recurring financial impact of BUNAVAIL discontinuation

3,750

0

0

Non-recurring financial impact of bargain purchase gain

0

0

(27,336

)

Non-GAAP net income/(loss)

$

13,156

$

(21,693

)

$

(994

)



Quarter Ended December 31,

Reconciliation of GAAP net income/(loss) to EBITDA (non-GAAP)

2019

2018

GAAP net income/(loss)

$

(696

)

$

(7,008

)

Add back:

Provision for income taxes

1

(40

)

Net interest expense

1,308

2,600

Depreciation and amortization

3,491

1,470

EBITDA

$

4,104

$

(2,978

)

Reconciliation of GAAP net income/(loss) to Non-GAAP net income/(loss)

GAAP net income/(loss)

(696

)

(7,008

)

Non-GAAP adjustments:

Stock-based compensation expense

1,438

1,045

Amortization of intangible assets

1,899

1,289

Amortization of warrant discount

269

Non-recurring financial impact of BUNAVAIL discontinuation

3,750

Non-GAAP net income/(loss)

$

6,391

$

(21,693

)