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): August 8, 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))

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

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 2.02.

Results of Operations and Financial Condition.

On August 8, 2019, BioDelivery Sciences International, Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 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 August 8, 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 long-term combined BELBUCA and Symproic net sales and BELBUCA and total company net sales 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 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.

 

August 8, 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

BioDelivery Sciences Reports Strong Second Quarter 2019 Results and Raises Net Sales Expectations

BELBUCA® Net Sales Increased 147% versus Prior Year to All-Time High of $24.1 Million

Raises Full-Year BELBUCA Net Sales Expectations to $90 – $93 Million

Raises Full-Year Total Company Net Sales Expectations to $101 – $105 Million

Raises Long-Term Combined Net Sales Expectations for BELBUCA and Symproic® to $425 – $500 Million

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

RALEIGH, N.C., August 8, 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 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 Coleman

Vice President, Investor Relations and Corporate Communications

BioDelivery 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  
  

 

 

   

 

 

 


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

Net disposals and purchase 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