Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 8, 2018

 

 

BioDelivery Sciences International, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-31361   35-2089858

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS 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

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under any of the following provisions:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 8.01.

Other Information.

On November 8, 2018, BioDelivery Sciences International, Inc. (the “Company”) issued a press release announcing financial results for the quarter ended September 30, 2018 and providing an update on the Company’s business operations, recent accomplishments, financial and company highlights, and anticipated milestones. A copy of the press release is attached as Exhibit 99.1 hereto.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

99.1    Press release, dated November 8, 2018, announcing the Company’s September 30, 2018 financial results.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K, the press release included herein (and the conference call referred to in such press release), and any statements of representatives and partners of the Company 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 Company’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 Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the continued growth in revenue and BELBUCA prescription, and the implementation and success of our BELBUCA strategic plan) may differ significantly from those set forth 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 Company’s control). The Company undertakes 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.

ONSOLIS®, BUNAVAIL® and BELBUCA® are registered trademarks of the Company. BUNAVAIL and BELBUCA logos are trademarks owned by the Company. All other trademarks and tradenames are owned by their respective owners.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

November 8, 2018     BIODELIVERY SCIENCES INTERNATIONAL, INC.
    By:  

/s/ Ernest R. De Paolantonio

    Name:   Ernest R. De Paolantonio
    Title:   Chief Financial Officer, Secretary and Treasurer
EX-99.1

Exhibit 99.1

 

LOGO

BioDelivery Sciences Reports Strong Third Quarter 2018 Financial Results

 

   

BELBUCA® continued on an accelerated growth trajectory, with revenue increasing 92% YOY and 27% versus prior quarter

 

   

BELBUCA total prescriptions experienced its largest quarter over quarter increase since launch

Conference Call And Webcast Scheduled For 4:30 PM ET Today

Raleigh, North Carolina – Nov. 08, 2018 — BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial stage specialty pharmaceutical company dedicated to patients living with chronic pain, today reported record financial results for the third quarter ending September 30, 2018, as well as the following operational and performance highlights:

Third Quarter Operational Highlights Include

 

   

Achieved strong BELBUCA® revenue performance with sales increasing to $12.4 million, up 92% YOY and 27% versus prior quarter

 

   

Sustained robust BELBUCA prescription growth achieving a new high of 44,180 TRxs, up 95% versus prior year and 25% versus prior quarter. The quarterly increase of 8,690 scripts versus prior quarter was the highest for the product since launch

 

   

Secured expanded market access for Belbuca to an additional 25 million lives, bringing the total population with preferred coverage to more than 75 million covered lives

 

   

Successfully began implementing its four point Belbuca strategic plan for sustained growth, including expanding the sales organization by more than 30% and starting to build the new medical team

 

   

Strengthened the executive leadership team with appointment of James Vollins as Company General Counsel, Chief Compliance Officer and Corporate Secretary

“I am very pleased by the results achieved during the third quarter across the organization,” stated Herm Cukier, CEO of BDSI. “Our continued focus on commercial execution enabled us to achieve very robust growth for BELBUCA and created a sizeable foundation to further build shareholder value for the long term. We also started implementing our previously announced four point BELBUCA strategic plan during the quarter, and were thrilled to strengthen our leadership team with the hiring of our new General Counsel. These elements of growth momentum and continued progress put us in a strong position to finish the year strong and build for future success.”

With the performance achieved through the first three quarters, and a strong balance sheet supporting the execution of the BELBUCA growth plan, the company is expecting total year 2018 financial performance for BELBUCA and total Company net revenue to be in the upper end of previous guidance.


LOGO

 

Third Quarter 2018 Financial Results

Total Net Revenue. Total net revenue for the third quarter ended September 30, 2018, was $14.2 million, an increase of 16% compared to $12.2 million in the second quarter of 2018, and an increase of 26% compared to $11.3 million in the third quarter of 2017.

BELBUCA® Net Revenue. BELBUCA net revenue in the third quarter ended September 30, 2018, was $12.4 million, an increase of 27% compared to second quarter 2018 revenue of $9.7 million, and an increase of 92% compared to third quarter 2017 revenue of $6.4 million.

Total Operating Expenses. Total operating expenses for the third quarter ended September 30, 2018, were $14.2 million, compared to second quarter 2018 expenses of $14.9 million, and third quarter 2017 expenses of $16.9 million.

Non-GAAP Net Loss for the third quarter of 2018 was $6.4 million or ($0.10) per share, compared to second quarter 2018 net loss of $9.8 million, or ($0.16) per diluted share, and a third quarter 2017 net loss of $12.0 million, or ($0.21) per diluted share.

GAAP Net Loss for the third quarter ended September 30, 2018 was $18.9 million, or ($0.29) per basic and diluted share, including a one-time non-cash charge of $12.5 million for the beneficial conversion feature of the Series B Preferred Stock.

Cash Position. At September 30, 2018, BDSI had cash and cash equivalents of approximately $49.5 million.

Conference Call & Webcast Details

BioDelivery Sciences will host a conference call and audio webcast today, November 8, 2018 at 4:30 p.m. ET to present third quarter 2018 results and provide a business update. Dial-in details are as follows:

 

Domestic:

   800-479-1004

International:

   323-794-2599

Passcode:

   9394131

Webcast:

   http://public.viavid.com/index.php?id=131852

Replays available through November 22, 2018

 

Domestic:    844-512-2921
International:    412-317-6671
Conference ID:    9394131

About BioDelivery Sciences International, Inc.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain. BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology and other drug delivery technologies 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.


LOGO

 

BDSI’s marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain and opioid dependence. BDSI’s headquarters is in Raleigh, North Carolina.

For more information, please visit or follow us:

 

Internet:    www.bdsi.com
Facebook:    Facebook.com/BioDeliverySI
Twitter:    @BioDeliverySI

BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) and BELBUCA® (buprenorphine) buccal film (CIII) are marketed in the U.S. by BioDelivery Sciences. For full prescribing information and important safety information on BDSI products please visit www.bdsi.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at (800) 469-0261. For full prescribing and safety information on BELBUCA, please visit www.BELBUCA.com and for full prescribing and safety information on BUNAVAIL, please visit www.bunavail.com.

Cautionary Note on Forward-Looking Statements

This press release, the presentation described herein, 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 revenue and Belbuca prescription, and the implementation and success of our Belbuca strategic plan) may differ significantly 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). 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.

BDSI®, BEMA®, ONSOLIS®, BUNAVAIL® and BELBUCA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences, BUNAVAIL and BELBUCA logos are trademarks owned by BioDelivery Sciences International, Inc. All other trademarks and tradenames are owned by their respective owners.

© 2018 BioDelivery Sciences International, Inc. All rights reserved.


LOGO

 

Contacts

Mary Coleman

Vice President, Investor Relations

BioDelivery Sciences International, Inc.

919-582-9050

mcoleman@bdsi.com

Monique Kosse

Managing Director

LifeSci Advisors

212-915-3820

monique@lifesciadvisors.com


BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(U.S. dollars, in thousands, except share and per share amounts)

(Unaudited)

 

     September 30,     December 31,  
     2018     2017  
ASSETS             

Current assets:

    

Cash and cash equivalents

   $ 49,482     $ 21,195  

Accounts receivable

     12,568       8,852  

Inventory

     5,434       6,091  

Prepaid expenses and other current assets

     4,155       3,610  
  

 

 

   

 

 

 

Total current assets

     71,639       39,748  

Property and equipment, net

     3,170       3,778  

Goodwill

     2,715       2,715  

BELBUCA license and distribution rights, net

     37,125       40,500  

Other intangible assets, net

     867       1,360  
  

 

 

   

 

 

 

Total assets

   $ 115,516     $ 88,101  
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY             

Current liabilities:

    

Accounts payable and accrued liabilities

   $ 23,919     $ 26,149  
  

 

 

   

 

 

 

Total current liabilities

     23,919       26,149  

Notes payable, net

     50,516       47,660  

Other long-term liabilities

     5,511       5,415  
  

 

 

   

 

 

 

Total liabilities

     79,946       79,224  

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 September 30, 2018 and December 31, 2017, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value, 3,100 and 0 shares outstanding at September 30, 2018 and December 31, 2017, respectively.

     2       2  

Common Stock, $.001 par value; 125,000,000 and 75,000,000 shares authorized at September 30, 2018 and December 31, 2017, respectively; 70,598,687 and 55,904,072 shares issued;70,583,196 and 55,888,581 shares outstanding at September 30, 2018 and December 31, 2017, respectively.

     71       56  

Additional paid-in capital

     379,824       313,922  

Treasury stock, at cost, 15,491 shares

     (47     (47

Accumulated deficit

     (344,280     (305,056
  

 

 

   

 

 

 

Total stockholders’ equity

     35,570       8,877  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 115,516     $ 88,101  
  

 

 

   

 

 

 


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,

 
     2018     2017     2018     2017  

Revenues:

        

Product sales

   $ 13,763     $ 8,118     $ 34,367     $ 23,798  

Product royalty revenues

     370       1,409       2,197       3,682  

Research and development reimbursements

     —         532       —         799  

Contract revenue

     23       1,194       1,047       21,194  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Revenues:

     14,156       11,253       37,611       49,473  
  

 

 

   

 

 

   

 

 

   

 

 

 

Cost of sales

     3,779       4,445       11,760       14,261  
  

 

 

   

 

 

   

 

 

   

 

 

 

Expenses:

        

Research and development:

     699       1,986       4,038       6,246  

Sales, general and administrative

     13,489       14,867       41,013       44,094  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Expenses:

     14,188       16,853       45,051       50,340  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (3,811     (10,045     (19,200     (15,128

Interest expense

     (2,567     (1,893     (7,598     (6,657

Other expense, net

     (2     (13     (8     (28

Bargain purchase gain

     —         —         —         27,336  
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income before income taxes

   $ (6,380   $ (11,951   $ (26,806   $ 5,523  
  

 

 

   

 

 

   

 

 

   

 

 

 

Income tax benefit

     —         —         (53     15,972  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income

   $ (6,380   $ (11,951   $ (26,859   $ 21,495  
  

 

 

   

 

 

   

 

 

   

 

 

 

Beneficial conversion feature of convertible preferred stock

     (12,500     —         (12,500     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income attributable to common stockholders

   $ (18,880   $ (11,951   $ (39,359   $ 21,495  
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic:

        

Basic (loss) income per share:

   $ (0.29   $ (0.21   $ (0.65   $ 0.39  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common stock shares outstanding:

     64,900,007       55,604,708       60,599,456       55,170,569  
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted:

        

Diluted (loss) income per share:

   $ (0.29   $ (0.21   $ (0.65   $ 0.38  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common stock shares outstanding:

     64,900,007       55,604,708       60,599,456       56,204,358  
  

 

 

   

 

 

   

 

 

   

 

 

 


BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(U.S. DOLLARS, IN THOUSANDS)

(Unaudited)

 

     Nine Months Ended September 30,  
     2018     2017  

Operating activities:

    

Net (loss) income

   $ (26,859   $ 21,495  

Depreciation

     685       465  

Accretion of debt discount and loan costs

     2,953       1,941  

Amortization of intangible assets

     3,868       4,103  

Impairment loss on equipment

     78       —    

Provision for inventory obsolescence

     396       —    

Stock-based compensation expense

     4,896       10,223  

Deferred income taxes

     —         (15,972

Bargain purchase gain

     —         (27,336

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

    

Accounts receivable

     (3,581     (7,222

Inventories

     261       2,314  

Prepaid expenses and other assets

     (545     1,826  

Accounts payable and accrued expenses

     (427     8,998  

Deferred Revenue

     —         (21,716
  

 

 

   

 

 

 

Net cash flows from operating activities

     (18,275     (20,881
  

 

 

   

 

 

 

Investing activities:

    

BELBUCA acquisition

     (1,951     (3,902

Purchase of equipment

     (155     (5
  

 

 

   

 

 

 

Net cash flows from investing activities

     (2,106     (3,907
  

 

 

   

 

 

 

Financing activities:

    

Proceeds from issuance of Series B preferred stock

     50,000       —    

Equity financing costs

     (1,410     —    

Proceeds from notes payable

     —         45,000  

Proceeds from exercise of stock options

     528       313  

Payment of notes payable

     —         (30,000

Payment of deferred financing fees

     (450     (2,798
  

 

 

   

 

 

 

Net cash flows from financing activities

     48,668       12,515  
  

 

 

   

 

 

 

Net change in cash and cash equivalents

     28,287       (12,273

Cash and cash equivalents at beginning of year

     21,195       32,019  
  

 

 

   

 

 

 

Cash and cash equivalents at end of year

   $ 49,482     $ 19,746  
  

 

 

   

 

 

 

Cash paid for interest

   $ 4,645     $ 3,816  
  

 

 

   

 

 

 


BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

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

(Unaudited)

 

    

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
     2018     2017     2018     2017  

Basic:

        

Net (loss) income under GAAP

   $ (18,880   $ (11,951   $ (39,359   $ 21,495  

Adjustment to beneficial conversion feature of convertible preferred stock

     12,500       —         12,500       —    

Net (loss) income attributable to common stockholders’ Non-GAAP

     (6,380     (11,951     (26,859     21,495  

Weighted average common stock shares outstanding:

     64,900,007       55,604,708       60,599,456       55,170,569  
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic (loss) income per common share

   $ (0.10   $ (0.21   $ (0.44   $ 0.39  
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted:

        

Net (loss) income under GAAP

   $ (18,880   $ (11,951   $ (39,359   $ 21,495  

Adjustment to beneficial conversion feature of convertible preferred stock

     12,500       —         12,500       —    

Net (loss) income attributable to common stockholders’ Non-GAAP

     (6,380     (11,951     (26,859     21,495  

Weighted average common stock shares outstanding:

     64,900,007       55,604,708       60,599,456       55,170,569  

Effect of dilutive options and warrants

     —         —         —         1,033,789  
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted weighted average common shares outstanding

     64,900,007       55,604,708       60,599,456       56,204,358  
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted (loss) income per common share

   $ (0.10   $ (0.21   $ (0.44   $ 0.38  
  

 

 

   

 

 

   

 

 

   

 

 

 


BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

(Unaudited)

 

    

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
     2018     2017     2018     2017  

Diluted EPS under GAAP

   $ (0.29   $ (0.21   $ (0.65   $ 0.38  

Diluted EPS adjustment to beneficial conversion feature of convertible preferred stock

     0.19       —         0.21       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted EPS Non-GAAP

   $ (0.10   $ (0.21   $ (0.44   $ 0.38