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): May 6, 2019

 

 

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.  ☐

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 Capital Market

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On May 6, 2019, BioDelivery Sciences International, Inc. (the “Company”) announced its financial results for the first quarter ended March 31, 2019. A copy of the press release is being furnished as Exhibit 99.1 to this Form 8-K.

The information in this Form 8-K (including Exhibit 99.1) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.
  

Description

99.1    Press release issued by the Company on May 6, 2019, furnished herewith.

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 BELBUCA net revenue and total net revenue in 2019 and the implementation and success of our Symproic 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. The Company has an exclusive license to use and display the Symproic registered trademark in order to commercialize Symproic in the United States. 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.

 

May 6, 2019     BIODELIVERY SCIENCES INTERNATIONAL, INC.
    By:  

/s/ Mary Theresa Coelho

    Name:   Mary Theresa Coelho
    Title:   Chief Financial Officer and Treasurer
EX-99.1

Exhibit 99.1

 

LOGO

BioDelivery Sciences Reports Strong First Quarter 2019 Results and Raises BELBUCA® Full-Year Expectations

BELBUCA® Net Sales Increased by 134% versus Prior Year to All-time High of $18.7 million

Symproic® Acquisition and Commercial Integration Successfully Completed

Company Raises Full-Year BELBUCA Net Sales Expectations to $83 - $88 Million

Confirms Full-Year Net Sales Expectations of $92 - $100 Million Including Symproic

Conference Call and Webcast scheduled for 4:30 PM ET Today

Raleigh, North Carolina – May 6, 2019 — 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 first quarter ended March 31, 2019, as well as the following operational and performance highlights:

Key Business Highlights:

 

   

BELBUCA® (buprenorphine buccal film) CIII prescription growth experienced an all-time year-over-year record increase of 141% as well as a 16% increase versus prior quarter. The 65,230 prescriptions during the quarter also represents a record level for any three-month period.

 

   

Total company revenue increased by 75% versus prior year to an all-time high of $19.8 million. Growth versus prior year was driven by strength of BELBUCA performance, partially offset by decline in Bunavail sales and timing of ex-US royalties.

 

   

Achieved record quarter over quarter growth in unique prescribers during the first quarter, reaching an all-time high of nearly 6,000.

 

   

Acquired rights to commercialize Symproic® (naldemedine) tablets 0.2 mg in the U.S. on April 4, with BDSI’s sales force fully trained and actively promoting Symproic as of May 2.

 

   

Successfully raised $50 million of gross proceeds in an underwritten public equity offering in April.

“We had an outstanding start to the year as demonstrated by the continued strong growth momentum of BELBUCA and the recent acquisition of Symproic,” stated Herm Cukier, Chief Executive Officer of BDSI. “The ability to seamlessly acquire and integrate a new product into our portfolio while achieving record-setting sales performance is a testament to the strong operational capabilities of our organization and gives me utmost confidence in our ability to sustain growth momentum for rest of year.”


LOGO

 

The company has increased its expectations for full-year 2019 BELBUCA net sales to $83 - $88 million from previous level of $80 - $85 million. The company also reiterated its total 2019 net sales expectations of $92 - $100 million, including Symproic 2019 net sales expectations of $7 - $9 million, and the expectation to have positive cash flow from operations by year end.

First Quarter 2019 Financial Results

Total Net Revenue. Total net revenue for the first quarter ended March 31, 2019, was $19.8 million, an increase of 10% compared to $18.0 million in the fourth quarter of 2018, and an increase of 75% compared to $11.3 million in the first quarter of 2018.

BELBUCA Net Sales. BELBUCA net sales in the first quarter ended March 31, 2019, was $18.7 million, an increase of 18% compared to $15.9 million in the fourth quarter 2018, and an increase of 134% compared to $8.0 million in the first quarter 2018.

Total Operating Expenses. Total operating expenses for the first quarter ended March 31, 2019, were $17.0 million, compared to $18.5 million in the fourth quarter of 2018, and $16.0 million in the first quarter of 2018.

Net Loss. Net loss for the first quarter ended March 31, 2019 was $3.8 million, or ($0.05) per share, compared to a loss of $7.0 million, or ($0.10) per share in the fourth quarter of 2018 and a loss of $10.7 million or ($0.18) per diluted share in the first quarter of 2018.

Conference Call & Webcast Details

BioDelivery Sciences will host a conference call and webcast today, May 6, 2019, at 4:30 p.m. ET to present first quarter 2019 results and to provide a business update. Dial-in details are as follows:

Conference Call Dial-In & Webcast Information:

 

Date:   Monday, May 6, 2019
Time:   4:30 PM Eastern Time
Domestic:   877-407-0789
International:   201-689-8562
Passcode:   13690336
Webcast:   http://public.viavid.com/index.php?id=134355


LOGO

 

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 conditions. 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. 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. For more information, please visit us at www.bdsi.com or follow us on Facebook.com/BioDeliverySI or Twitter BDSI @BioDeliverySI.

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 2018 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.


BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

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

(Unaudited)

 

     March 31,     December 31,  
     2019     2018  
ASSETS     

Current assets:

    

Cash

   $ 41,329     $ 43,822  

Accounts receivable, net.

     16,008       13,627  

Inventory, net

     7,259       5,406  

Prepaid expenses and other current assets

     2,970       3,188  
  

 

 

   

 

 

 

Total current assets

     67,566       66,043  

Property and equipment, net

     3,952       3,072  

Goodwill

     2,715       2,715  

BELBUCA license and distribution rights, net

     34,875       36,000  

Other intangible assets, net

     539       703  
  

 

 

   

 

 

 

Total assets

   $ 109,647     $ 108,533  
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable and accrued liabilities

   $ 23,484     $ 21,539  
  

 

 

   

 

 

 

Total current liabilities

     23,484       21,539  

Notes payable, net

     52,286       51,652  

Other long-term liabilities

     6,355       5,600  
  

 

 

   

 

 

 

Total liabilities

     82,125       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 March 31, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value, 2,400 and 3,100 shares outstanding at March 31, 2019 and December 31, 2018, respectively.

     2       2  

Common Stock, $.001 par value; 125,000,000 shares authorized at March 31, 2019 and December 31, 2018, respectively; 75,333,254 and 75,793,725 shares issued;75,317,763 and 70,778,234 shares outstanding at March 31, 2019 and December 31, 2018, respectively.

     74       71  

Additional paid-in capital

     382,614       381,004  

Treasury stock, at cost, 15,491 shares

     (47     (47

Accumulated deficit

     (355,121     (351,288
  

 

 

   

 

 

 

Total stockholders’ equity

     27,522       29,742  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 109,647     $ 108,533  
  

 

 

   

 

 

 


BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

     Three Months Ending March 31,  
     2019     2018  

Revenues:

    

Product sales

     19,759       9,838  

Product royalty revenues

     2       440  

Contract revenue

     8       1,003  
  

 

 

   

 

 

 

Total Revenues

     19,769       11,281  
  

 

 

   

 

 

 

Cost of sales

     4,052       3,415  
  

 

 

   

 

 

 

Expenses:

    

Research and development:

     —         2,484  

Selling, general and administrative

     16,989       13,505  
  

 

 

   

 

 

 

Total expenses

     16,989       15,989  
  

 

 

   

 

 

 

Loss from operations

     (1,272     (8,123
  

 

 

   

 

 

 

Interest expense, net

     (2,561     (2,505

Other expense, net

     —         (7
  

 

 

   

 

 

 

Loss before income taxes

   $ (3,833   $ (10,635
  

 

 

   

 

 

 

Income tax expense

     —         (74
  

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (3,833   $ (10,709
  

 

 

   

 

 

 

Basic and diluted:

    

Weighted average common stock shares outstanding

     71,344,831       58,062,997  
  

 

 

   

 

 

 

Basic and diluted loss per share

   $ (0.05   $ (0.18
  

 

 

   

 

 

 


BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(U.S. DOLLARS, IN THOUSANDS)

 

     Three Months Ending March 31,  
     2019     2018  

Operating activities:

    

Net loss

   $ (3,833   $ (10,709

Adjustments to reconcile net loss to net cash flows from operating activities

    

Depreciation

     85       230  

Accretion of debt discount and loan costs

     634       625  

Amortization of Intangible Assets

     1,289       1,289  

Provision (benefit) for inventory obsolescence

     149       (66

Stock based compensation expense

     1,141       2,921  

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

    

Accounts receivable

     (2,381     864  

Inventories

     (2,002     716  

Prepaid expenses and other assets

     218       782  

Accounts payable and accrued expenses

     1,814       (3,413

Deferred revenue

     —         —    
  

 

 

   

 

 

 

Net cash flows from operating activities

     (2,886     (6,761
  

 

 

   

 

 

 

Investing activities:

    

BELBUCA Acquisitions

     —         (1,951

Purchase of equipment

     —         (73

Disposal of property and equipment

     (79     —    
  

 

 

   

 

 

 

Net cash flows from investing activities

     (79     (2,024
  

 

 

   

 

 

 

Financing activities:

    

Proceeds from exercise of stock options

     472       130  

Payment of deferred financing fees

     —         (450
  

 

 

   

 

 

 

Net cash flows from (used in) by financing activities

     472       (320
  

 

 

   

 

 

 

Net change in cash and cash equivalents

     (2,493     (9,105

Cash and cash equivalents at beginning of year

     43,822       21,195  
  

 

 

   

 

 

 

Cash and cash equivalents at end of year

   $ 41,329     $ 12,090  
  

 

 

   

 

 

 

Cash paid for interest

   $ 1,931     $ 1,880