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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________________________
FORM 10-Q
__________________________________
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2020
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period from
to
Commission file number 001-31361
__________________________________
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
__________________________________
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Delaware |
35-2089858 |
(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
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4131 ParkLake Ave., Suite 225, Raleigh, NC
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27612 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number (including area code):
919-582-9050
__________________________________
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
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Trading
Symbol(s) |
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Name of each exchange
on which registered |
Common stock, par value $0.001 |
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BDSI |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing
requirements for the past 90
days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period
that the registrant was required to submit such
files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, or a non-accelerated
filer, a smaller reporting company or an emerging growth company.
See definition of “large accelerated filer”, “accelerated filer”
and “smaller reporting company”, or “emerging growth company” in
Rule 12b-2 of the Exchange Act. (Check one):
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Large Accelerated Filer |
☐ |
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Accelerated Filer
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Non-Accelerated Filer |
☐ |
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Smaller Reporting Company |
☐ |
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Emerging Growth Company |
☐ |
If an emerging growth company, indicate by check mark if the
registrant has elected not 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. ☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange
Act). Yes ☐ No ☒
As of November 5, 2020, there were 101,126,462 shares of
company Common Stock issued and 101,110,971 shares of company
Common Stock outstanding.
BioDelivery Sciences International, Inc. and
Subsidiaries
Quarterly Report on Form 10-Q
TABLE OF CONTENTS
We own various trademark registrations and applications, and
unregistered trademarks, including BioDelivery Sciences
International, Inc., BEMA, BELBUCA, BUNAVAIL, ONSOLIS and our
corporate logo. We have an exclusive license to use and display the
Symproic registered trademark in order to commercialize Symproic in
the United States. All other trade names, trademarks and service
marks of other companies appearing in this prospectus are the
property of their respective holders. Solely for convenience, the
trademarks and trade names in this prospectus may be referred to
without the ® and
™ symbols, but such references should not be construed as any
indicator that their respective owners will not assert, to the
fullest extent under applicable law, their rights thereto. We do
not intend to use or display other companies’ trademarks and trade
names to imply a relationship with, or endorsement or sponsorship
of us by, any other companies.
From time to time, we may use our website, our Facebook page
at
Facebook.com/BioDeliverySI,
on Twitter at @BioDeliverySI and on LinkedIn at
linkedin.com/company/biodeliverysciencesinternational to distribute
material information. Our financial and other material information
is routinely posted to and accessible on the "Investors" section of
our website, available at
www.bdsi.com.
Investors are encouraged to review the Investors section of our
website because we may post material information on that site that
is not otherwise disseminated by us. Information that is contained
in and can be accessed through our website, our Facebook page, our
LinkedIn page and our Twitter posts are not incorporated into, and
does not form a part of, this Quarterly Report.
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE
AMOUNTS)
(Unaudited)
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September 30,
2020 |
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December 31,
2019 |
ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
100,177 |
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$ |
63,888 |
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Accounts receivable, net |
43,830 |
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38,790 |
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Inventory, net |
18,887 |
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11,312 |
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Prepaid expenses and other current assets |
5,754 |
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3,769 |
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Total current assets |
168,648 |
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117,759 |
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Property and equipment, net |
1,485 |
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2,075 |
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Goodwill |
2,715 |
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2,715 |
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License and distribution rights, net |
55,109 |
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60,309 |
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Other intangible assets, net |
— |
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47 |
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Total assets |
$ |
227,957 |
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$ |
182,905 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
$ |
53,409 |
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$ |
53,993 |
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Total current liabilities |
53,409 |
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53,993 |
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Notes payable, net |
78,363 |
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58,568 |
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Other long-term liabilities |
300 |
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580 |
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Total liabilities |
132,072 |
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113,141 |
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Commitments and contingencies (Note 9) |
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Stockholders’ equity: |
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Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting
Convertible Preferred Stock. $0.001 par value, 0 and 2,093,155
shares outstanding at September 30, 2020 and December 31,
2019, respectively; Series B Non-Voting Convertible Preferred
Stock, $0.001 par value, 443 and 618 shares outstanding at
September 30, 2020 and December 31, 2019,
respectively.
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— |
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2 |
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Common Stock, $0.001 par value; 235,000,000 and 175,000,000 shares
authorized at September 30, 2020 and December 31, 2019,
respectively; 101,126,452 and 96,189,074 shares issued; 101,110,961
and 96,173,583 shares outstanding at September 30, 2020 and
December 31, 2019, respectively.
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100 |
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96 |
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Additional paid-in capital |
446,910 |
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436,306 |
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Treasury stock, at cost, 15,491 shares, as of September 30,
2020 and December 31, 2019.
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(47) |
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(47) |
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Accumulated deficit |
(351,078) |
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(366,593) |
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Total stockholders’ equity |
95,885 |
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69,764 |
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Total liabilities and stockholders’ equity |
$ |
227,957 |
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$ |
182,905 |
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See notes to condensed consolidated financial
statements
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE
AMOUNTS)
(Unaudited)
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Three months ended September 30, |
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Nine months ended September 30, |
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2020 |
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2019 |
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2020 |
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2019 |
Revenues: |
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Product sales, net |
$ |
38,785 |
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$ |
29,623 |
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$ |
112,946 |
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$ |
77,438 |
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Product royalty revenues |
658 |
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683 |
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1,358 |
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2,154 |
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Contract revenues |
— |
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— |
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— |
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160 |
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Total Revenues: |
39,443 |
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30,306 |
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114,304 |
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79,752 |
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Cost of sales |
5,376 |
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5,350 |
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16,371 |
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14,325 |
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Expenses: |
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Selling, general and administrative |
22,461 |
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23,360 |
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77,408 |
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62,304 |
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Total Expenses: |
22,461 |
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23,360 |
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77,408 |
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62,304 |
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Income from operations |
11,606 |
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1,596 |
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20,525 |
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3,123 |
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Interest expense, net |
(2,010) |
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(1,234) |
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(4,997) |
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(17,732) |
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Other (expense)/income, net |
(2) |
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(3) |
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6 |
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5 |
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Income/(loss) before income taxes |
$ |
9,594 |
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$ |
359 |
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$ |
15,534 |
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$ |
(14,604) |
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Income tax provision |
(211) |
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(5) |
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(19) |
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(5) |
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Net income/(loss) attributable to common stockholders |
$ |
9,383 |
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$ |
354 |
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$ |
15,515 |
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$ |
(14,609) |
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Basic |
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Weighted average common stock shares outstanding |
101,031,317 |
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89,649,922 |
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99,377,748 |
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81,612,112 |
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Basic earnings/(loss) per share |
$ |
0.09 |
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$ |
— |
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$ |
0.16 |
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$ |
(0.18) |
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Diluted |
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Weighted average common stock shares outstanding |
105,783,568 |
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105,138,894 |
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104,836,493 |
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81,612,112 |
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Diluted earnings/(loss) per share |
$ |
0.09 |
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$ |
— |
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$ |
0.15 |
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$ |
(0.18) |
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See notes to condensed consolidated financial
statements
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE AND PER SHARE
AMOUNTS)
(Unaudited)
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Preferred Stock Series A |
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Preferred Stock Series B |
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Common Stock |
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Additional Paid-In Capital |
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Treasury Stock |
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Accumulated Deficit |
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Total Stockholders’ Equity |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
|
Balances, June 30, 2020 |
— |
|
|
$ |
— |
|
|
443 |
|
|
$ |
— |
|
|
100,916,511 |
|
|
$ |
99 |
|
|
$ |
445,180 |
|
|
$ |
(47) |
|
|
$ |
(360,462) |
|
|
$ |
84,770 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,539 |
|
|
— |
|
|
— |
|
|
1,539 |
|
Stock option exercises |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
68,623 |
|
|
1 |
|
|
191 |
|
|
— |
|
|
— |
|
|
192 |
|
Restricted stock awards |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
141,318 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Net income |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
9,384 |
|
|
9,384 |
|
Balances, September 30, 2020 |
— |
|
|
$ |
— |
|
|
443 |
|
|
$ |
— |
|
|
101,126,452 |
|
|
$ |
100 |
|
|
$ |
446,910 |
|
|
$ |
(47) |
|
|
$ |
(351,078) |
|
|
$ |
95,885 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock Series A |
|
Preferred Stock Series B |
|
Common Stock |
|
Additional Paid-In Capital |
|
Treasury Stock |
|
Accumulated Deficit |
|
Total Stockholders’ Equity |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Balances, June 30, 2019 |
2,093,155 |
|
|
$ |
2 |
|
|
1,716 |
|
|
$ |
— |
|
|
89,535,024 |
|
|
$ |
88 |
|
|
$ |
432,358 |
|
|
$ |
(47) |
|
|
$ |
(366,251) |
|
|
$ |
66,150 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,267 |
|
|
— |
|
|
— |
|
|
1,267 |
|
Stock option exercises |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
52,121 |
|
|
— |
|
|
123 |
|
|
— |
|
|
— |
|
|
123 |
|
Restricted stock awards |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
109,629 |
|
|
2 |
|
|
(2) |
|
|
— |
|
|
— |
|
|
— |
|
Series B conversion to common stock |
— |
|
|
— |
|
|
(18) |
|
|
— |
|
|
100,000 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
354 |
|
|
354 |
|
Balances, September 30, 2019 |
2,093,155 |
|
|
$ |
2 |
|
|
1,698 |
|
|
$ |
— |
|
|
89,796,774 |
|
|
$ |
90 |
|
|
$ |
433,746 |
|
|
$ |
(47) |
|
|
$ |
(365,897) |
|
|
$ |
67,894 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock
Series A |
|
Preferred Stock
Series B |
|
Common Stock |
|
Additional
Paid-In
Capital |
|
Treasury
Stock |
|
Accumulated
Deficit |
|
Total
Stockholders’
Equity |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Balances, January 1, 2020 |
2,093,155 |
|
|
$ |
2 |
|
|
618 |
|
|
$ |
— |
|
|
96,189,074 |
|
|
$ |
96 |
|
|
$ |
436,306 |
|
|
$ |
(47) |
|
|
$ |
(366,593) |
|
|
$ |
69,764 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
7,845 |
|
|
— |
|
|
— |
|
|
7,845 |
|
Stock option exercises |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,159,347 |
|
|
1 |
|
|
2,760 |
|
|
— |
|
|
— |
|
|
2,761 |
|
Restricted stock awards |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
712,654 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Series A conversion to common stock |
(2,093,155) |
|
|
(2) |
|
|
— |
|
|
— |
|
|
2,093,155 |
|
|
2 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Series B conversion to common stock |
— |
|
|
— |
|
|
(175) |
|
|
— |
|
|
972,222 |
|
|
1 |
|
|
(1) |
|
|
— |
|
|
— |
|
|
— |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
15,515 |
|
|
15,515 |
|
Balances, September 30, 2020 |
— |
|
|
$ |
— |
|
|
443 |
|
|
$ |
— |
|
|
101,126,452 |
|
|
$ |
100 |
|
|
$ |
446,910 |
|
|
$ |
(47) |
|
|
$ |
(351,078) |
|
|
$ |
95,885 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock
Series A |
|
Preferred Stock
Series B |
|
Common Stock |
|
Additional
Paid-In
Capital |
|
Treasury
Stock |
|
Accumulated
Deficit |
|
Total
Stockholders’
Equity |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Balances, January 1, 2019 |
2,093,155 |
|
|
$ |
2 |
|
|
3,100 |
|
|
$ |
— |
|
|
70,793,725 |
|
|
$ |
71 |
|
|
$ |
381,004 |
|
|
$ |
(47) |
|
|
$ |
(351,288) |
|
|
$ |
29,742 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
3,978 |
|
|
— |
|
|
— |
|
|
3,978 |
|
Stock option exercises |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
412,500 |
|
|
— |
|
|
1,193 |
|
|
— |
|
|
— |
|
|
1,193 |
|
Restricted stock awards |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
801,661 |
|
|
1 |
|
|
(1) |
|
|
— |
|
|
— |
|
|
— |
|
Series B conversion to Common Stock |
— |
|
|
— |
|
|
(1,402) |
|
|
— |
|
|
7,788,888 |
|
|
8 |
|
|
(8) |
|
|
— |
|
|
— |
|
|
— |
|
Equity offering, net of finance costs |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
10,000,000 |
|
|
10 |
|
|
47,580 |
|
|
— |
|
|
— |
|
|
47,590 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(14,609) |
|
|
(14,609) |
|
Balances, September 30, 2019 |
2,093,155 |
|
|
$ |
2 |
|
|
1,698 |
|
|
$ |
— |
|
|
89,796,774 |
|
|
$ |
90 |
|
|
$ |
433,746 |
|
|
$ |
(47) |
|
|
$ |
(365,897) |
|
|
$ |
67,894 |
|
See notes to condensed consolidated financial
statements
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. DOLLARS, IN THOUSANDS)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
|
2020 |
|
2019 |
Operating activities: |
|
|
|
Net income/(loss) |
$ |
15,515 |
|
|
$ |
(14,609) |
|
Adjustments to reconcile net income/(loss) to net cash flows from
operating activities |
|
|
|
Depreciation |
467 |
|
|
253 |
|
Accretion of debt discount and loan costs |
231 |
|
|
11,441 |
|
Amortization of intangible assets |
5,248 |
|
|
5,084 |
|
Provision for inventory obsolescence |
(297) |
|
|
57 |
|
Stock-based compensation expense |
7,845 |
|
|
3,978 |
|
Changes in assets and liabilities: |
|
|
|
Accounts receivable |
(5,040) |
|
|
(19,795) |
|
Inventories |
(7,278) |
|
|
(5,416) |
|
Prepaid expenses and other assets |
(1,985) |
|
|
(1,686) |
|
Accounts payable and accrued liabilities |
(701) |
|
|
14,844 |
|
Taxes payable |
(40) |
|
|
— |
|
Net cash flows provided by/(used in) operating
activities |
13,965 |
|
|
(5,849) |
|
Investing activities: |
|
|
|
Product acquisitions |
— |
|
|
(20,674) |
|
Acquisitions of equipment |
— |
|
|
(79) |
|
Net cash flows used in investing activities |
— |
|
|
(20,753) |
|
Financing activities: |
|
|
|
Proceeds from issuance of common stock |
— |
|
|
48,000 |
|
Equity issuance costs |
— |
|
|
(410) |
|
Proceeds from notes payable |
20,000 |
|
|
60,000 |
|
Proceeds from exercise of stock options |
2,761 |
|
|
1,193 |
|
Payment on note payable |
— |
|
|
(67,346) |
|
Loss on refinancing of former debt |
— |
|
|
(2,794) |
|
Payment on deferred financing fees |
(437) |
|
|
— |
|
Net cash flows provided by financing activities |
22,324 |
|
|
38,643 |
|
Net change in cash and cash equivalents |
36,289 |
|
|
12,041 |
|
Cash and cash equivalents at beginning of period |
63,888 |
|
|
43,822 |
|
Cash and cash equivalents at end of period |
$ |
100,177 |
|
|
$ |
55,863 |
|
Cash paid for interest |
$ |
5,037 |
|
|
$ |
3,831 |
|
See notes to condensed consolidated financial
statements
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
1. Organization, basis of presentation and summary of significant
policies:
Overview
BioDelivery Sciences International, Inc., together with its
subsidiaries (collectively, the “Company”) is a rapidly growing
specialty pharmaceutical company dedicated to patients living with
serious and complex chronic conditions. The Company has built a
portfolio of products that includes utilizing its novel and
proprietary BioErodible MucoAdhesive ("BEMA") drug-delivery
technology to develop and commercialize new applications of proven
therapies aimed at addressing important unmet medical needs. The
Company commercializes its products in the U.S. using its own sales
force while working in partnership with third parties to
commercialize its products outside the U.S.
The accompanying unaudited condensed consolidated financial
statements include all adjustments (consisting of normal and
recurring adjustments) necessary for a fair presentation of these
financial statements. The condensed consolidated balance sheet at
December 31, 2019 has been derived from the Company’s audited
consolidated financial statements included in its annual report on
Form 10-K for the year ended December 31, 2019. Certain
footnote disclosures normally included in financial statements
prepared in accordance with GAAP have been condensed or omitted
pursuant to the Securities and Exchange Commission rules and
regulations. It is recommended that these condensed consolidated
financial statements be read in conjunction with the consolidated
financial statements and notes thereto included in the Company’s
annual report on Form 10-K for the year ended
December 31, 2019.
As used herein, the Company’s common stock, par value $0.001 per
share, is referred to as the “Common Stock” and the Company’s
preferred stock, par value $0.001 per share, is referred to as the
“Preferred Stock”.
Principles of consolidation
The condensed consolidated financial statements include the
accounts of the Company, Arius Pharmaceuticals, Inc. and Arius Two,
Inc. All significant inter-company balances and transactions have
been eliminated.
Use of estimates in financial statements
The preparation of the accompanying condensed consolidated
financial statements requires management to make estimates and
assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at
the date of the condensed consolidated financial statements and the
reported amounts of revenues and expenses during the period. Actual
results could differ from those estimates. The Company reviews all
significant estimates affecting the condensed consolidated
financial statements on a recurring basis and records the effect of
any necessary adjustments prior to their issuance. Significant
estimates made by the Company include: revenue recognition
associated with sales allowances such as government program
rebates, customer voucher redemptions, commercial contracts,
rebates and chargebacks; sales returns reserves; sales bonuses;
stock-based compensation; and deferred income taxes.
Cash and cash equivalents
Cash and cash equivalents consist of operating and money market
accounts. Cash equivalents are carried at cost which approximates
fair value due to their short-term nature. The Company considers
all highly-liquid investments with an original maturity of 90 days
or less to be cash equivalents.
The Company maintains cash equivalent balances with financial
institutions that management believes are of high credit quality.
The Company’s cash and cash equivalents accounts at times may
exceed federally insured limits. The Company has not experienced
any losses in such accounts. The Company believes it is not exposed
to any significant credit risk from cash and cash
equivalents.
Inventory
Inventories are stated at the lower of cost or net realizable value
with costs determined for each batch under the first-in, first-out
method and specifically allocated to remaining
inventory. Inventory consists of raw materials, work in
process and finished goods. Raw materials include amounts of active
pharmaceutical ingredient for a product to be manufactured; work in
process
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
includes the bulk inventory of laminate (the Company’s drug
delivery film) prior to being packaged for sale; and finished goods
include pharmaceutical products ready for commercial
sale.
On a quarterly basis, the Company analyzes its inventory levels and
records allowances for inventory that has become obsolete,
inventory that has a cost basis in excess of the expected net
realizable value and inventory that is in excess of expected demand
based upon projected product sales. Inventory obsolescence reserves
at September 30, 2020 and December 31, 2019 were $0.1 million
and $0.4 million, respectively.
Revenue recognition
The main types of revenue contracts are:
•Product
sales-Product
sales amounts relate to sales of BELBUCA, Symproic and BUNAVAIL.
The Company discontinued marketing of BUNAVAIL in August 2020. The
Company recognizes revenue on product sales when control of the
promised goods is transferred to its customers in an amount that
reflects the consideration expected to be received in exchange for
transferring those goods. The Company accounts for a contract when
it has approval and commitment from both parties, the rights of the
parties are identified, payment terms are identified, the contract
has commercial substance and collectability of consideration is
probable. When determining whether the customer has obtained
control of the goods, the Company considers any future performance
obligations. Generally, there is no post-shipment obligation on
product sold.
•Product
royalty revenues-Product
royalty revenue amounts are based on sales revenue of the PAINKYL
product under the Company’s license agreement with TTY and the
BREAKYL product under the Company’s license agreement with Meda AB,
which was acquired by Mylan N.V. (which we refer to herein as
Mylan). Product royalty revenues are recognized when control of the
product is transferred to the license partner in an amount that
reflects the consideration expected to be received. Supplemental
sales-based product royalty revenue may also be earned upon the
subsequent sale of the product at agreed upon contractual
rates.
•Contract
revenue-Contract
revenue amounts are related to milestone payments under the
Company’s license agreements with its partners.
Performance obligations
A performance obligation is a promise in a contract to transfer a
distinct good or service to the customer. A contract’s transaction
price is allocated to each distinct performance obligation and
recognized as revenue when, or as, the performance obligation is
satisfied. The majority of the Company’s product sales contracts
have a single performance obligation as the promise to transfer the
individual goods is not separately identifiable from other promises
in the contracts and, therefore, not distinct. The Company’s
performance obligations are satisfied at a point in time. The
multiple performance obligations are not allocated based off of the
obligations but based off of standard selling price.
Transaction price, including variable consideration
Revenue from product sales is recorded at the net sales price,
which includes estimates of variable consideration for which
reserves are established. Components of variable consideration
include trade discounts and allowances, product returns, government
chargebacks, discounts and rebates, and other incentives, such as
voucher programs, and other fee for service amounts that are
detailed within contracts between the Company and its customers
relating to the Company’s sale of its products.
The Company establishes allowances for estimated rebates,
chargebacks and product returns based on numerous qualitative and
quantitative factors, including:
•specific
contractual terms of agreements with customers;
•estimated
levels of inventory in the distribution channel;
•historical
rebates, chargebacks and returns of products;
•direct
communication with customers;
•anticipated
introduction of competitive products or generics;
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
•anticipated
pricing strategy changes by the Company and/or its
competitors;
•analysis
of prescription data gathered by third-party prescription data
providers;
•the
impact of changes in state and federal regulations;
and
•the
estimated remaining shelf life of products.
Revenue from product sales is recorded after considering the impact
of the following variable consideration amounts at the time of
revenue recognition:
Product returns-Consistent
with industry practice, the Company offers contractual return
rights that allow its customers to return the products within an
18-month period that begins six months prior to and ends twelve
months after expiration of the products.
Government rebates and chargebacks-Government
rebates and chargebacks include mandated discounts under Medicaid,
Medicare, U.S. Department of Veterans Affairs and other government
agencies ("Government Payors"). The Company estimates the rebates
and chargebacks to Government Payors based upon a range of possible
outcomes that are probability-weighted for the estimated payor mix.
These reserves are recorded in the same period the revenue is
recognized, resulting in a reduction of product revenue and the
establishment of a current liability, which is included in accrued
expenses and other current liabilities on the condensed
consolidated balance sheets. In addition, the pricing of covered
products under Medicaid is subject to complex calculations and
involves interpretation of government rules, regulations and
policies as well as adjustments based on current trends in
utilization. For Medicare, the Company also estimates the number of
patients in the prescription drug coverage gap for whom the Company
will owe an additional liability under the Medicare Part D program.
The Company estimates the rebates and chargebacks that it will
provide to Government Payors based upon (i) the government-mandated
discounts applicable to government-funded programs, (ii)
information obtained from its customers and (iii) information
obtained from other third parties regarding the payor mix for its
products. The Company’s liability for these rebates consists of
estimates of claims for the current quarter and estimated future
claims that will be made for product shipments that have been
recognized as revenue, but remain in the distribution channel
inventories at the end of each reporting period.
Commercial Contracts-The
Company’s estimates of rebates arising from commercial contracts
are based on its estimated mix of various third-party payers, which
are contractually entitled to discounts from the Company’s listed
prices of its products. If the mix across third-party payers is
different from the Company’s estimates, the Company may be required
to pay higher or lower total price adjustments and/or chargebacks
than it had estimated.
Voucher program-The
Company, from time to time, offers certain promotional
product-related incentives to eligible patients. The Company has
voucher programs for BELBUCA and Symproic whereby the Company
offers a point-of-sale subsidy to retail consumers. The Company
estimates its liabilities for these voucher programs based on the
current utilization and historical redemption rates as reported to
the Company by a third-party claims processing organization. The
Company accounts for the costs of these special promotional
programs as price adjustments, which are a reduction of gross
revenue.
Trade discounts and distribution fees-Trade
discounts relate to prompt settlement discounts provided to
customers. In addition, the Company compensates its customers for
distribution of its products and the provision of data. The Company
has determined that such services received to date are not distinct
from its sale of products and may not reasonably represent fair
value for these services. Therefore, estimates of these payments
are recorded as a reduction of revenue based on contractual
terms.
Cost of sales
Cost of sales includes the direct costs attributable to the
production of BELBUCA, Symproic and BUNAVAIL. It includes raw
materials, production costs at the Company’s contract manufacturing
sites, quality testing directly related to the products, and
depreciation on equipment that the Company has purchased to produce
BELBUCA, Symproic and BUNAVAIL. It also includes the costs for
any batches not meeting specifications and raw material yield
losses. Yield losses and batches not meeting specifications
are expensed as incurred. Cost of sales is recognized when sold to
the wholesaler from our distribution center.
For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough
cancer pain therapies), cost of sales includes all costs related
to creating the product at the Company’s contract
manufacturing location in Germany. The Company’s
contract
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
manufacturer bills the Company for the final product, which
includes materials, direct labor costs, and certain overhead costs
as outlined in applicable supply agreements.
Cost of sales also includes royalty expenses that the Company owes
to third parties.
Recent accounting pronouncements-adopted
Measurement of Credit Losses of Financial Instruments
In June 2016, the FASB issued ASU No. 2016-13, Financial
Instruments – Credit Losses (Topic 326): Measurement of Credit
Losses of Financial Instruments; in November 2018 the FASB issued a
subsequent amendment ASU No. 2018-19, Codification Improvements to
Topic 326, Financial Instruments—Credit Losses; in April 2019 the
FASB issued ASU No. 2019-04, Codification Improvements to Topic
326, Financial Instruments—Credit Losses. In May 2019 the FASB
issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic
326): Targeted Transition Relief; and in November 2019 the FASB
issued ASU No. 2019-11, Codification Improvements to Topic 326,
Financial Instruments—Credit Losses. The new guidance changes the
methodology for measuring credit losses on financial instruments
and the timing of when such losses are recorded. In November 2019
the FASB issued ASU No. 2019-10, Financial Instruments—Credit
Losses (Topic 326). The Company adopted Topic 326 during the nine
months ended September 30, 2020 and determined that the new
guidance has no material impact on its condensed consolidated
financial statements.
The Company is exposed to credit losses primarily through its
product sales. The Company assesses each counterparty’s ability to
pay for the products it sells by conducting a credit review. The
credit review considers the Company's expected billing exposure and
timing for payment and the counterparty’s established credit rating
or the Company's assessment of the counterparty’s creditworthiness
based on the Company's analysis of their financial statements when
a credit rating is not available. The Company also considers
contract terms and conditions, and business strategy in its
evaluation. A credit limit is established for each counterparty
based on the outcome of this review.
The Company monitors its ongoing credit exposure through active
review of counterparty balances against contract terms and due
dates. The Company's activities include timely account
reconciliations, dispute resolution and payment confirmations. The
Company may employ collection agencies and legal counsel to pursue
recovery of defaulted receivables.
As of September 30, 2020, the Company reported
$43.8 million of trade receivables within accounts receivable.
Based on an aging analysis at September 30, 2020, 98% of the
Company's accounts receivable were outstanding less than 30 days.
There was no change to the allowance for doubtful accounts and
credit losses between September 30, 2020 or December 31, 2019.
The Company writes off accounts receivable when management
determines they are uncollectible and credits payments subsequently
received on such receivables to bad debt expense in the period
received.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement
(Topic 820): Disclosure Framework-Changes to the Disclosure
Requirements for Fair Value Measurement, which modifies the
disclosure requirements on fair value measurements. This guidance
is effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2019 and early adoption
is permitted. The new guidance does not have a material impact on
its consolidated financial statements.
In November 2018, the FASB issued ASU 2018-18, Collaborative
Arrangements (Topic 808): Clarifying the Interaction between Topic
808 and Topic 606, which amends ASC 808 to clarify ASC 606 should
apply in entirety to certain transactions between collaborative
arrangement participants. This guidance is effective for fiscal
years, and interim periods within those fiscal years, beginning
after December 15, 2019. The Company has determined that the new
guidance does not have a material impact on its consolidated
financial statements.
Recent accounting pronouncements-not yet adopted
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic
740)—Simplifying the Accounting for Income Taxes, which is intended
to simplify accounting for income taxes. It removes certain
exceptions to the general principles in Topic 740 and amends
existing guidance to improve consistent application. This guidance
is effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2020 and early adoption
is permitted. The Company is currently evaluating but does not
expect the new guidance to have a material impact on its
consolidated financial statements.
Fair Value of Financial Instruments
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
The Company measures the fair value of instruments in accordance
with GAAP which defines fair value, establishes a framework for
measuring fair value, and expands disclosures about fair value
measurements.
GAAP defines fair value as the exchange price that would be
received for an asset or paid to transfer a liability (an exit
price) in the principal or most advantageous market for the asset
or liability in an orderly transaction between market participants
on the measurement date. GAAP also establishes a fair value
hierarchy, which requires an entity to maximize the use of
observable inputs and minimize the use of unobservable inputs when
measuring fair value. The Company considers the carrying amount of
its cash and cash equivalents to approximate fair value due to
short-term nature of this instrument. GAAP describes three levels
of inputs that may be used to measure fair value:
Level 1 – quoted prices in active markets for identical assets
or liabilities
Level 2 – quoted prices for similar assets and liabilities in
active markets or inputs that are observable
Level 3 – inputs that are unobservable (for example cash flow
modeling inputs based on assumptions)
The following table summarizes the financial instruments measured
at fair value on a recurring basis as of September 30,
2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Balance at September 30, 2020 |
Cash and cash equivalents |
$ |
100,177 |
|
|
$ |
— |
|
|
— |
|
$ |
100,177 |
|
The cash and cash equivalent balance as of September 30, 2020
includes investments in various money market accounts and cash held
in interest bearing accounts.
2. Inventory:
The following table represents the components of inventory as
of:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2020 |
|
December 31,
2019 |
Raw materials |
$ |
3,497 |
|
|
$ |
624 |
|
Work-in-process |
10,025 |
|
|
6,198 |
|
Finished goods |
5,452 |
|
|
4,874 |
|
Obsolescence reserve |
(87) |
|
|
(384) |
|
Total inventories |
$ |
18,887 |
|
|
$ |
11,312 |
|
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
3. Accounts payable and accrued liabilities:
The following table represents the components of accounts payable
and accrued liabilities as of:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2020 |
|
December 31,
2019 |
Accounts payable |
$ |
8,244 |
|
|
$ |
11,704 |
|
Accrued rebates |
28,156 |
|
|
28,528 |
|
Accrued compensation and benefits |
5,603 |
|
|
5,545 |
|
Accrued returns |
6,947 |
|
|
4,438 |
|
Accrued royalties |
684 |
|
|
535 |
|
Accrued legal |
1,564 |
|
|
1,484 |
|
Accrued regulatory expenses |
1,252 |
|
|
331 |
|
Accrued other |
959 |
|
|
1,428 |
|
Total accounts payable and accrued liabilities |
$ |
53,409 |
|
|
$ |
53,993 |
|
4. Property and equipment:
Property and equipment, summarized by major category, consist of
the following as of:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2020 |
|
December 31,
2019 |
Machinery & equipment |
$ |
4,683 |
|
|
$ |
5,635 |
|
Right of use, building lease |
536 |
|
|
720 |
|
Computer equipment & software |
259 |
|
|
437 |
|
Office furniture & equipment |
174 |
|
|
174 |
|
Leasehold improvements |
43 |
|
|
43 |
|
Idle equipment |
679 |
|
|
679 |
|
Construction in progress |
61 |
|
|
— |
|
Total |
6,435 |
|
|
7,688 |
|
Less accumulated depreciation and amortization |
(4,950) |
|
|
(5,613) |
|
Total property and equipment, net |
$ |
1,485 |
|
|
$ |
2,075 |
|
Depreciation expense for the three-month periods ended
September 30, 2020 and September 30, 2019, was
approximately $0.02 million and $0.08 million, respectively.
Depreciation expense for the nine-month periods ended
September 30, 2020 and September 30, 2019, was
approximately $0.5 million and $0.2 million, respectively.
Depreciation expense for the nine-month period ended
September 30, 2020 includes a $0.3 million one-time
charge due to BUNAVAIL equipment write-off.
5. Intangible assets:
Other intangible assets, net, consisting of product rights and
licenses are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
Gross Carrying
Value |
|
Accumulated
Amortization |
|
Intangible Assets,
net |
|
Product rights |
|
$ |
6,050 |
|
|
$ |
(6,050) |
|
|
$ |
— |
|
|
BELBUCA license and distribution rights |
|
45,000 |
|
|
(16,875) |
|
|
28,125 |
|
|
Symproic license and distribution rights |
|
30,636 |
|
|
(3,652) |
|
|
26,984 |
|
|
Total intangible assets |
|
$ |
81,686 |
|
|
$ |
(26,577) |
|
|
$ |
55,109 |
|
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019 |
|
Gross Carrying
Value |
|
Accumulated
Amortization |
|
Intangible Assets,
net |
Product rights |
|
$ |
6,050 |
|
|
$ |
(6,003) |
|
|
$ |
47 |
|
BELBUCA license and distribution rights |
|
45,000 |
|
|
(13,500) |
|
|
31,500 |
|
Symproic license and distribution rights |
|
30,636 |
|
|
(1,827) |
|
|
28,809 |
|
Total intangible assets |
|
$ |
81,686 |
|
|
$ |
(21,330) |
|
|
$ |
60,356 |
|
6. Notes payable:
On May 23, 2019, the Company entered into a Loan Agreement
with BPCR LIMITED PARTNERSHIP (the successor-in-interest to
Biopharma Credit plc), for a senior secured credit facility
consisting of a term loan of $60.0 million (the “Term Loan”), with
the ability to draw an additional $20 million within twelve months
of the closing date, which the Company drew down on May 22,
2020.
The loan facility carries a 72-month term with interest
only payments on the term loan for the first 36 months. The Term
Loan will mature in May 2025 and bears an interest rate of 7.5%
plus the LIBOR rate on the first day for the quarter, with a floor
of 2% plus the LIBOR rate. (LIBOR effective rate as of July 1, 2020
was 0.30%.) The Term Loan is subject to mandatory prepayment
provisions that require prepayment upon change of
control.
The debt balance has been categorized within Level 2 of the fair
value hierarchy. The notes payable debt balance as of
September 30, 2020 approximates its fair value based on
prevailing interest rates as of the balance sheet
date.
The following table represents future maturities of the notes
payable obligation as of September 30, 2020:
|
|
|
|
|
|
|
|
|
|
2020 |
— |
|
|
2021 |
— |
|
|
2022 |
18,462 |
|
|
2023 |
24,615 |
|
|
2024 |
24,615 |
|
|
2025 |
12,308 |
|
|
Total maturities |
$ |
80,000 |
|
|
Unamortized discount and loan costs |
(1,637) |
|
|
Total notes payable obligation |
$ |
78,363 |
|
7. Net sales by product:
The Company’s business is classified as a single reportable
segment.
However, the following table presents net sales by
product:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30,
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
BELBUCA |
$ |
34,758 |
|
|
$ |
26,514 |
|
|
$ |
100,572 |
|
|
$ |
69,277 |
|
% of net product sales |
90 |
% |
|
90 |
% |
|
89 |
% |
|
89 |
% |
Symproic |
3,453 |
|
|
2,172 |
|
|
11,046 |
|
|
5,348 |
|
% of net product sales |
9 |
% |
|
7 |
% |
|
10 |
% |
|
7 |
% |
BUNAVAIL |
574 |
|
|
937 |
|
|
1,328 |
|
|
2,813 |
|
% of net product sales |
1 |
% |
|
3 |
% |
|
1 |
% |
|
4 |
% |
Net product sales |
$ |
38,785 |
|
|
$ |
29,623 |
|
|
$ |
112,946 |
|
|
$ |
77,438 |
|
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
In June 2020, we discontinued distribution of BUNAVAIL in the U.S.
The revenue reflected in the three months ended September 30, 2020
for BUNAVAIL reflects the release of certain reserves taken at the
time the discontinuation was announced.
8. Stockholders’ equity:
Common Stock
On July 23, 2020, in connection with the Company’s 2020 Annual
Meeting of Stockholders, the Company’s stockholders approved, among
other matters, an amendment to the Company’s Certificate of
Incorporation to increase the number of authorized shares of Common
Stock from 175,000,000 to 235,000,000.
On November 4, 2020, the Board of Directors authorized the
repurchase of up to $25 million of the Company's shares of
Common Stock. The timing and amount of any shares purchased on the
open market will be determined based on the Company's evaluation of
market conditions, share price and other factors. The Company plans
to utilize existing cash on hand to fund the share repurchase
program.
Stock-based compensation
During the nine months ended September 30, 2020, a total of
2,639,978 options to purchase Common Stock, with an aggregate fair
market value of approximately $6.8 million, were granted to
employees, officers, a director and the Interim Chief Executive
Officer of the Company. Options have a term of 10 years from the
grant date. Options granted to employees, officers and the director
will vest ratably over a three-year period. Of the aforementioned
option grants, 160,000 options, estimated to be valued at
approximately $0.3 million, offered to the Chief Executive Officer
("CEO") in connection with his role as Interim Chief Executive
Officer fully vested on November 4, 2020 upon his appointment
to permanent CEO on that date. In addition, 840,000 options,
estimated to be valued at approximately $1.7 million, were granted
to the CEO on November 4, 2020 in connection with his
appointment to the role, and vest ratably over three years. Options
previously granted to the former Chief Executive Officer vested
upon his termination as Chief Executive Officer, and will be
exercisable for a period of three years. The fair value of each
option is amortized as compensation expense evenly through the
vesting period.
The fair value of each option award is estimated on the grant date
using the Black-Scholes valuation model that uses assumptions for
expected volatility, expected dividends, expected term, expected
rate of forfeiture and the risk-free interest rate. Expected
volatilities are based on implied volatilities from historical
volatility of the Common Stock, and other factors estimated over
the expected term of the options.
Expected term of options granted is derived using the “simplified
method” which computes expected term as the average of the sum of
the vesting term plus contract term. The risk-free rate is based on
the U.S. Treasury yield curve in effect at the time of grant for
the period of the expected term.
The key assumptions used in determining the fair value of options
granted during the nine months ended September 30, 2020
follows:
|
|
|
|
|
|
Expected price volatility |
59.00%-61.76%
|
Risk-free interest rate |
0.25%-1.68%
|
Weighted average expected life in years |
6 years |
Dividend yield |
— |
|
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
Option activity during the nine months ended September 30,
2020 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
shares |
|
Weighted average
exercise price per
share |
|
Aggregate
intrinsic
value |
Outstanding at January 1, 2020 |
5,496,971 |
|
|
$ |
3.64 |
|
|
$ |
15,455 |
|
Granted in 2020: |
|
|
|
|
|
Officers and Directors |
1,430,801 |
|
|
$ |
5.64 |
|
|
|
Employees |
1,209,177 |
|
|
$ |
5.65 |
|
|
|
Exercised |
(1,159,347) |
|
|
$ |
2.38 |
|
|
|
Forfeitures |
(365,188) |
|
|
$ |
4.37 |
|
|
|
Outstanding at September 30, 2020 |
6,612,414 |
|
|
$ |
4.62 |
|
|
$ |
1,620 |
|
As of September 30, 2020, options exercisable totaled
3,008,632. There are approximately $7.6 million of
unrecognized compensation costs related to non-vested share-based
compensation awards, including options and restricted stock units
(“RSUs”) granted. These costs will be expensed through
2023.
Restricted stock units
During the nine months ended September 30, 2020, a cumulative
total of 302,404 RSUs were granted to the Company’s executive
officers, a member of senior management, directors and the Interim
Chief Executive Officer in connection with his role as Interim
Chief Executive Officer with a fair market value of approximately
$1.5 million. Of the aforementioned RSU grants, 40,000 RSUs,
estimated to be valued at approximately $0.2 million, granted to
the Chief Executive Officer ("CEO") in connection with his role as
Interim Chief Executive Officer fully vested on November 4,
2020 upon his appointment to permanent CEO on that date. In
addition, 160,000 RSUs, valued at approximately $0.6 million, were
granted to the CEO upon his appointment on November 4, 2020,
and vest ratably over three years. The fair value of restricted
units is determined using quoted market prices of the Common Stock
and the number of shares expected to vest. RSU grants are
time-based, all of which generally vest from a
one to three-year period.
Restricted stock activity during the nine months ended
September 30, 2020 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
restricted
shares |
|
Weighted
average fair
market value
per RSU |
Outstanding at January 1, 2020 |
1,648,559 |
|
|
$ |
3.86 |
|
Granted in 2020: |
|
|
|
Officers and Directors |
289,949 |
|
|
$ |
5.17 |
|
Employees |
12,455 |
|
|
$ |
5.50 |
|
Vested |
(712,654) |
|
|
$ |
2.72 |
|
Forfeitures |
(407,217) |
|
|
$ |
4.31 |
|
Outstanding at September 30, 2020 |
831,092 |
|
|
$ |
3.82 |
|
Warrants
The Company has granted warrants to purchase shares of Common
Stock. Warrants may be granted to affiliates in connection with
certain agreements. There were no warrants issued during the nine
months ended September 30, 2020 and as of September 30, 2020,
a cumulative of 2,136,019 warrants remain outstanding.
Preferred Stock
During the nine months ended September 30, 2020, 175 shares of
Series B Preferred Stock (“Series B”) were converted into 972,222
shares of Common Stock. As of September 30, 2020, 443 shares
of Series B are outstanding.
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
During the nine months ended September 30, 2020, 2,093,155
shares of Series A Preferred Stock (“Series A”) were converted on a
one-for-one basis into shares of Common Stock. There are no
remaining outstanding shares of Series A as of September 30,
2020.
Earnings Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Basic: |
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders,
basic |
$ |
9,383 |
|
|
$ |
354 |
|
|
$ |
15,515 |
|
|
$ |
(14,609) |
|
Weighted average common shares outstanding |
101,031,317 |
|
|
89,649,922 |
|
|
99,377,748 |
|
|
81,612,112 |
|
Basic earnings (loss) per common share |
$ |
0.09 |
|
|
$ |
— |
|
|
$ |
0.16 |
|
|
$ |
(0.18) |
|
Diluted: |
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders,
diluted |
$ |
9,383 |
|
|
$ |
354 |
|
|
$ |
15,515 |
|
|
$ |
(14,609) |
|
Weighted average common shares outstanding |
101,031,317 |
|
|
89,649,922 |
|
|
99,377,748 |
|
|
81,612,112 |
|
Effect of dilutive options and warrants |
4,752,251 |
|
|
15,488,972 |
|
|
5,458,745 |
|
|
— |
|
Dilutive weighted average common shares outstanding |
105,783,568 |
|
|
105,138,894 |
|
|
104,836,493 |
|
|
81,612,112 |
|
Diluted earnings (loss) per common share |
$0.09 |
|
$— |
|
$0.15 |
|
$(0.18) |
During the three months ended September 30, 2020 and the nine
months ended September 30, 2020, outstanding stock options, RSUs,
warrants and preferred shares of 4,752,251 and 5,458,745,
respectively, were included in the computation of diluted earnings
per common share.
During the three months ended September 30, 2019, outstanding stock
options, RSUs, warrants and preferred shares of 15,488,972 were
included in the computation of diluted earnings per common share.
During the nine months ended September 30, 2019, outstanding stock
options, RSUs, warrants and preferred shares of 15,260,949 were not
included in the computation of diluted earnings per common share,
because to do so would have had an antidilutive
effect.
9. Commitments and contingencies:
The Company is involved from time to time in routine legal
matters incidental to our business. Based upon available
information, the Company believes that the resolution of such
matters will not have a material adverse effect on its condensed
consolidated financial position or results of operations. Except as
discussed below, the Company is not the subject of any pending
legal proceedings and, to the knowledge of management, no
proceedings are presently contemplated against the Company by any
federal, state or local governmental agency.
Indivior (formerly RB Pharmaceuticals Ltd.) and Aquestive
Therapeutics (formerly MonoSol Rx)
The following disclosure regarding the Company’s ongoing
litigations with Aquestive Therapeutics, Inc. (formerly MonoSol Rx,
“Aquestive”) and Indivior PLC (formerly RB Pharmaceuticals Limited,
“Indivior”) is intended to provide some background and an update on
the matter as per disclosure requirements of the SEC. Additional
details regarding the past procedural history of the matter can be
found in the Company’s previously filed periodic filings with the
SEC.
Litigation related to BUNAVAIL
On October 29, 2013, Reckitt Benckiser, Inc., Indivior, and
Aquestive (collectively, the “RB Plaintiffs”) filed an action
against the Company relating to its BUNAVAIL product in the United
States District Court for the Eastern District of North Carolina
(“EDNC”) for alleged patent infringement. BUNAVAIL is a drug
approved for the maintenance treatment of opioid
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
dependence. The RB Plaintiffs claim that the formulation for
BUNAVAIL, which has never been disclosed publicly, infringes its US
Patent No. 8,475,832 (the “‘832 Patent”). On May 21, 2014, the
Court granted the Company’s motion to dismiss.
On January 22, 2014, Aquestive initiated an inter partes review
(“IPR”) on U.S. Patent No. 7,579,019, the (“‘019 Patent”). The PTAB
upheld all claims of the Company’s ‘019 Patent in 2015 and this
decision was not appealed by Aquestive.
On September 20, 2014, the Company proactively filed a declaratory
judgment action in the United States District Court for the EDNC
requesting the Court to make a determination that the Company’s
BUNAVAIL product does not infringe the ‘832 Patent, US Patent No.
7,897,080 (the “‘080 Patent”) and US Patent No. 8,652,378 (the
“‘378 Patent”). The Company invalidated the “‘080 Patent” in its
entirety in an inter partes reexamination proceeding. The Company
invalidated all relevant claims of the ‘832 Patent in an IPR
proceeding. And, in an IPR proceeding for the ‘378 Patent, in its
decision not to institute the IPR proceeding, the PTAB construed
the claims of the ‘378 Patent narrowly. Shortly thereafter, by
joint motion of the parties, the ‘378 Patent was subsequently
removed from the action.
On June 6, 2016, in an unrelated case in which Indivior and
Aquestive asserted the ‘832 Patent against other parties, the
Delaware District Court entered an order invalidating other claims
in the ‘832 Patent. Indivior and Aquestive cross-appealed all
adverse findings in that decision to the Court of Appeals for the
Federal Circuit in Case No. 17-2587. The Company’s declaratory
judgment action remains stayed pending the outcome of that
cross-appeal by Indivior and Aquestive.
On September 22, 2014, the RB Plaintiffs filed an action against
the Company (and the Company’s commercial partner) relating to the
Company’s BUNAVAIL product in the United States District Court for
the District of New Jersey for alleged patent infringement. The RB
Plaintiffs claim that BUNAVAIL, whose formulation and manufacturing
processes have never been disclosed publicly, infringes its patent
U.S. Patent No. 8,765,167 (the “‘167 Patent”). The Company believes
this is an anticompetitive attempt by the RB Plaintiffs to distract
the Company’s efforts from commercializing BUNAVAIL.
On December 12, 2014, the Company filed a motion to transfer the
case from New Jersey to North Carolina and a motion to dismiss the
case against its commercial partner. On October 28, 2014, the
Company filed multiple IPR petitions on certain claims of the ‘167
Patent. The USPTO instituted three of the four IPR petitions. The
PTAB upheld the claims and denied collateral estoppel applied to
the PTAB decisions in March 2016. The Company appealed to Court of
Appeals for the Federal Circuit. The USPTO intervened with respect
to whether collateral estoppel applied to the PTAB.
On June 19, 2018, the Company filed a motion to remand the case for
further consideration by the PTAB in view of intervening authority.
On July 31, 2018, the Federal Circuit vacated the decisions, and
remanded the ‘167 Patent IPRs for further consideration on the
merits.
On February 7, 2019, the PTAB issued three decisions on remand
purporting to deny institution of the three previously instituted
IPRs of the ‘167 patent. On March 11, 2019, the Company timely
appealed the PTAB decisions on remand to U.S. Court of Appeal for
the Federal Circuit. On March 20, 2019, Aquestive and Indivior
moved to dismiss the appeal, and the Company opposed that
motion.
On August 29, 2019, a three-judge panel of the Court of Appeals for
the Federal Circuit granted the motion and dismissed the Company’s
appeal. On September 30, 2019, the Company filed a petition for an
en banc rehearing of the order dismissing the Company’s appeal by
the full Federal Circuit Court of Appeals.
On January 13, 2020, by the Court of Appeals for the Federal
Circuit denied BDSI’s petition for en banc rehearing of the
dismissal of BDSI’s appeal relating to inter partes review
proceedings on the ’167 patent. On June 11, 2020, BDSI filed a
petition for certiorari seeking U.S. Supreme Court review of the
Federal Circuit’s decision. On October 5, 2020, the U.S. Supreme
Court denied the Company’s petition for certiorari.
Litigation related to BELBUCA
On January 13, 2017, Aquestive filed a complaint in the United
States District Court for the District of New Jersey alleging
BELBUCA infringes the ‘167 Patent. In lieu of answering the
complaint, the Company filed motions to dismiss the complaint and,
in the alternative, to transfer the case to the EDNC. On July 25,
2017, the New Jersey Court administratively terminated the case
pending the parties submission of a joint stipulation of transfer
because the District of New Jersey was an
inappropriate
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
venue. This case was later transferred to the Delaware District
Court. On October 31, 2017, the Company filed motions to dismiss
the complaint and, in the alternative, to transfer the case to the
EDNC. On October 16, 2018, denying the motion to dismiss as moot,
the Delaware District Court granted the Company’s motion to
transfer the case to the EDNC. On November 20, 2018, the Company
moved the EDNC to dismiss the complaint for patent infringement for
failure to state a claim for relief.
On August 6, 2019, the EDNC granted the Company’s motion to
dismiss, and dismissed the complaint without prejudice. On or about
November 11, 2019, Aquestive refiled a complaint in the EDNC
against the Company alleging that BELBUCA infringes the ‘167
Patent. The Company strongly refutes as without merit Aquestive’s
assertion of patent infringement and will vigorously defend the
lawsuit.
Teva Pharmaceuticals USA (formerly Actavis)
On February 8, 2016, the Company received a notice relating to a
Paragraph IV certification from Teva Pharmaceuticals USA, or
(formerly Actavis, “Teva”) seeking to find invalid three Orange
Book listed patents relating specifically to BUNAVAIL. The
Paragraph IV certification related to an ANDA filed by Teva with
the FDA for a generic formulation of BUNAVAIL. The patents subject
to Teva’s certification were the ‘019 Patent, U.S. Patent No.
8,147,866 (the “‘866 Patent”) and 8,703,177 (the “‘177
Patent”).
On March 18, 2016, the Company asserted three different patents
against Teva, the ‘019 Patent, the ‘866 Patent, and the ‘177
Patent. Teva did not raise non-infringement positions about the
‘019 and the ‘866 Patents in its Paragraph IV certification. Teva
did raise a non-infringement position on the ‘177 Patent but the
Company asserted in its complaint that Teva infringed the ‘177
Patent either literally or under the doctrine of
equivalents.
On December 20, 2016 the USPTO issued U.S. Patent No. 9,522,188
(the “‘188 Patent””), and this patent was properly listed in the
Orange Book as covering the BUNAVAIL product. On February 23, 2017
Teva sent a Paragraph IV certification adding the 9,522,188 to its
ANDA. An amended Complaint was filed, adding the ‘188 Patent to the
litigation.
On January 31, 2017, the Company received a notice relating to a
Paragraph IV certification from Teva relating to Teva’s ANDA on
additional strengths of BUNAVAIL and on March 16, 2017, the Company
brought suit against Teva and its parent company on these
additional strengths. On June 20, 2017, the Court entered orders
staying both BUNAVAIL suits at the request of the
parties.
On May 23, 2017, the USPTO issued U.S. Patent 9,655,843 (the “‘843
Patent”) relating to the BEMA technology, and this patent was
properly listed in the Orange Book as covering the BUNAVAIL
product.
Finally, on October 12, 2017, the Company announced that it had
entered into a settlement agreement with Teva that resolved the
Company’s BUNAVAIL patent litigation against Teva pending in the
U.S. District Court for the District of Delaware. As part of the
Settlement Agreement, which is subject to review by the U.S.
Federal Trade Commission and the U.S. Department of Justice, the
Company has entered into a non-exclusive license agreement with
Teva that permits Teva to first begin selling its generic version
of BUNAVAIL in the U.S. on July 23, 2028 or earlier under certain
circumstances. Other terms of the agreement are
confidential.
The Company received notices regarding Paragraph IV certifications
from Teva on November 8, 2016, November 10, 2016, and December 22,
2016, seeking to find invalid two Orange Book listed patents
relating specifically to BELBUCA. The Paragraph IV certifications
relate to three ANDAs filed by Teva with the FDA for a generic
formulation of BELBUCA. The patents subject to Teva’s certification
were the ‘019 Patent and the ‘866 Patent. The Company filed
complaints in Delaware against Teva on December 22, 2016 and
February 3, 2017 in which it asserted against Teva the ‘019 Patent
and the ‘866 Patent. Teva did not contest infringement of the
claims of the ‘019 Patent and did not contest infringement of the
claims of the ‘866 Patent. The ‘019 Patent had already been the
subject of an unrelated IPR before the USPTO under which the
Company prevailed, and all claims of the ‘019 Patent survived.
Aquestive’s request for rehearing of the final IPR decision
regarding the ‘019 Patent was denied by the USPTO on December 19,
2016. Aquestive did not file a timely appeal at the Federal
Circuit.
On May 23, 2017, the USPTO issued U.S. Patent 9,655,843 (the “‘843
Patent”) relating to the BEMA technology, and this patent was
properly listed in the Orange Book as covering the BELBUCA
product.
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
On August 28, 2017, the Court entered orders staying both BELBUCA
suits at the request of the parties.
In February 2018, the Company announced that it had entered into a
settlement agreement with Teva that resolved the Company’s BELBUCA
patent litigation against Teva pending in the U.S. District Court
for the District of Delaware. As part of the settlement agreement,
which is subject to review by the U.S. Federal Trade Commission and
the U.S. Department of Justice, the Company has granted Teva a
non-exclusive license (for which the Company will receive no
current or future payments) that permits Teva to first begin
selling the generic version of the Company’s BELBUCA product in the
U.S. on January 23, 2027 or earlier under certain circumstances
(including, for example, upon (i) the delisting of the
patents-in-suit from the U.S. FDA Orange Book, (ii) the granting of
a license by us to a third party to launch another generic form of
BELBUCA at a date prior to January 23, 2027, or (iii) the
occurrence of certain conditions regarding BELBUCA market share).
Other terms of the Agreement are confidential.
Alvogen
On September 7, 2018, the Company filed a complaint for patent
infringement in Delaware against Alvogen Pb Research &
Development LLC, Alvogen Malta Operations Ltd., Alvogen Pine Brook
LLC, Alvogen, Incorporated, and Alvogen Group, Incorporated
(collectively, “Alvogen”), asserting that Alvogen infringes the
Company’s Orange Book listed patents for BELBUCA®, including U.S.
Patent Nos. 8,147,866 and 9,655,843, both expiring in July of 2027,
and U.S. Patent No. 9,901,539, expiring in December of 2032. This
complaint follows receipt by the Company on July 30, 2018 of a
Paragraph IV Patent Certification from Alvogen stating that Alvogen
had filed an ANDA with the FDA for a generic version of BELBUCA®
Buccal Film (75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg
and 900 mcg). Because the Company initiated a patent infringement
suit to defend the patents identified in the Paragraph IV notice
within 45 days after receipt of the Paragraph IV Certification, the
FDA is prevented from approving the ANDA until the earlier of 30
months or a decision in the case that each of the patents is not
infringed or invalid. Alvogen’s notice letter also does not provide
any information on the timing or approval status of its
ANDA.
In its Paragraph IV Certification, Alvogen does not contest
infringement of at least several independent claims of each of the
’866, ’843, and ’539 patents. Rather, Alvogen advances only
invalidly arguments for these independent claims. The Company
believes that it will be able to prevail on its claims of
infringement of these patents, particularly as Alvogen does not
contest infringement of certain claims of each patent.
Additionally, as the Company has done in the past, it intends to
vigorously defend its intellectual property against assertions of
invalidity. Each of the three patents carry a presumption of
validity, which can only be overcome by clear and convincing
evidence.
The Court has scheduled a bench trial to commence on November 9,
2020 to adjudicate issues concerning the validity of the Orange
Book patents listed for BELBUCA. On October 6, 2020, the Court
rescheduled the bench trial with Alvogen to commence on March 1,
2021.
2018 Arkansas Opioid Litigation
On March 15, 2018, the State of Arkansas, and certain counties and
cities in that State, filed an action in the Circuit Court of
Arkansas, Crittenden County against multiple manufacturers,
distributors, retailers, and prescribers of opioid analgesics,
including the Company. The Company was served with the complaint on
April 27, 2018. The complaint specifically alleged that it licensed
its branded fentanyl buccal soluble film ONSOLIS to Collegium, and
Collegium is also named as a defendant in the lawsuit. ONSOLIS is
not presently sold in the United States and the license agreement
with Collegium was terminated prior to Collegium launching ONSOLIS
in the United States. Therefore, on June 28, 2018, the Company
moved to dismiss the case against it and most recently, on July 6,
2018, the plaintiffs filed a notice to voluntarily dismiss us from
the Arkansas case, without prejudice.
Chemo Research, S.L
On March 1, 2019, the Company filed a complaint for patent
infringement in Delaware against Chemo Research, S.L., Insud Pharma
S.L., IntelGenx Corp., and IntelGenx Technologies Corp.
(collectively, the “Chemo Defendants”), asserting that the Chemo
Defendants infringe its Orange Book listed patents for BELBUCA,
including U.S. Patent Nos. 8,147,866 and 9,655,843, both expiring
in July of 2027, and U.S. Patent No. 9,901,539 expiring December of
2032. This complaint follows a receipt by the Company on January
31, 2019, of a Notice Letter from Chemo Research S.L. stating that
it has filed with the
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
FDA an ANDA containing a Paragraph IV Patent Certification, for a
generic version of BELBUCA Buccal Film in strengths 75 mcg, 150
mcg, 300 mcg, 450 mcg, and 900 mcg. Because the Company initiated a
patent infringement suit to defend the patents identified in the
Notice Letter within 45 days after receipt, the FDA is prevented
from approving the ANDA until the earlier of 30 months or a
decision in the case that each of the patents is not infringed or
invalid. Chemo Research S.L.’s Notice Letter also does not provide
any information on the timing or approval status of its ANDA. On
March 15, 2019, the Company filed a complaint against the
Defendants in New Jersey asserting the same claims for patent
infringement made in the Delaware lawsuit. On April 19, 2019,
Defendants filed an answer to the Delaware complaint wherein they
denied infringement of the ‘866, ‘843 and ‘539 patents and asserted
counterclaims seeking declaratory relief concerning the alleged
invalidity and non-infringement of such patents.
On April 25, 2019, the Company voluntarily dismissed the New Jersey
lawsuit given Defendants’ consent to jurisdiction in
Delaware.
The Court has scheduled a bench trial to commence on November 9,
2020 (jointly with Alvogen) to adjudicate issues concerning the
validity of the Orange Book patents listed for BELBUCA. On October
6, 2020, the Court rescheduled the bench trial with Chemo and
Alvogen to adjudicate issues concerning the validity of the Orange
Book patents listed for BELBUCA to commence on March 1, 2021. The
Court has scheduled a bench trial to commence on May 3, 2021 to
adjudicate issues concerning the Chemo Defendants’ infringement of
the Orange Book patents.
The Company believes that it will be able to prevail in this
lawsuit. As it has done in the past, the Company intends to
vigorously defend its intellectual property against assertions of
invalidity.
Derivative Litigation
On July 2, 2018, the Company filed a Schedule 14A Proxy Statement
(the “Proxy”) with the U.S. Securities and Exchange Commission (the
“SEC”) in connection with its 2018 Annual Meeting. Proposals 1 and
2 of the Proxy sought stockholder approval to amend the Company’s
Certificate of Incorporation by deleting Article TWELFTH of the
Company’s Certificate of Incorporation in its entirety and
replacing it with a new Article TWELFTH that, among other things
(i) provided for the declassification of the Company’s Board in
phases, with the full declassification to be achieved in 2020 (the
“Declassification Amendment”) and (ii) changed the voting standard
for the uncontested election of directors to the Board from a
plurality standard to the majority of votes cast standard as set
forth in the bylaws of the Company (the “Election Amendment” and
together with the “Declassification Amendment”, the
“Amendments”).
On August 2, 2018, the Company held the 2018 Annual Meeting, at
which time the stockholders voted on the Amendments. Following the
2018 Annual Meeting, based on consultation with the Company’s
advisors, the Company determined that the Amendments had been
adopted by the requisite vote of stockholders and effected the
Amendments by filing a Certificate of Amendment to the Certificate
of Incorporation with the Secretary of State of the State of
Delaware on August 6, 2018.
On September 11, 2019, two purported stockholders of the Company
filed a putative class action against the Company and our directors
in the Court of Chancery of the State of Delaware, captioned
Drachman v. BioDelivery Sciences International, Inc., et al., C.A.
No. 2019-0728-AGB (Del. Ch.) (the “Complaint”). The Complaint
alleges that the Amendments did not receive the requisite vote of
stockholders at the 2018 Annual Meeting and asserts claims for
violation of the Delaware General Corporation Law, breach of
fiduciary duties, and declaratory judgment. The Complaint seeks,
inter alia, a declaration that the Amendments were not validly
approved and invalidation of the Amendments, including altering the
one-year terms of all directors duly elected at the 2018 and 2019
Annual Meetings to three-year terms. The Complaint also seeks costs
and disbursements, including attorneys’ fees. On July 1, 2020, the
Company filed its response to the Complaint and denied the claims
asserted therein.
On November 5, 2019, the Board determined that ratifying the
declassification of the Board and the change in the voting standard
as set forth in the Amendments, as well as ratifying the filing and
effectiveness of the Amendments, is in the best interests of the
Company and its stockholders. The Board thus approved resolutions
ratifying such acts and the filing and effectiveness of the
Amendments under Section 204 of the Delaware General Corporation
Law. On July 23, 2020, the stockholders of the Company approved the
ratification of the declassification of the Board and the change in
the voting standard as set forth in the Amendments as well as the
filing and effectiveness of the Amendments. On July 23, 2020, the
Company filed a Certificate of Validation with the Delaware
Secretary of State.
BIODELIVERY SCIENCES INTERNATIONAL, INC. AND
SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. DOLLARS, IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
On October 8, 2020, the Court entered an agreed-to order dismissing
the plaintiffs’ claims for violation of the Delaware General
Corporation Law.
On October 13, 2020, plaintiffs filed an amended complaint,
asserting individual, class and derivative claims for breach of
fiduciary duties against our directors.
On October 26, 2020, the Company and our directors filed a motion
to dismiss the amended complaint.
The Company intends to continue to defend against the litigation
vigorously.
Item 2. Management’s Discussion and
Analysis of Financial Condition and Results of
Operations.
The following discussion and analysis should be read in conjunction
with the Condensed Consolidated Financial Statements and Notes
thereto included elsewhere in this Quarterly Report. This
discussion contains certain forward-looking statements that involve
risks and uncertainties. Our actual results and the timing of
certain events could differ materially from those discussed in
these forward-looking statements as a result of certain factors,
including, but not limited to, those set forth herein and elsewhere
in this Quarterly Report and in our other filings with the SEC. See
“Cautionary Note Regarding Forward-Looking Statements”
below.
Overview
Strategy
Our strategy is evolving with the establishment of our commercial
footprint in the management of chronic conditions. We seek to
continue to build a well-balanced, diversified, high-growth
specialty pharmaceutical company. Through our industry-leading
commercialization infrastructure, we are executing the
commercialization of our existing products. As part of our
corporate growth strategy, we have licensed, and will continue to
explore opportunities to acquire or license, additional products
that meet the needs of patients living with debilitating chronic
conditions and treated primarily by therapeutic specialists. As we
gain access to these drugs and technologies, we plan to employ our
commercialization experience to bring them to the marketplace. With
a strong commitment to patient access and a focused
business-development approach for transformative acquisitions or
licensing opportunities, we plan to leverage our experience and
apply it to developing new partnerships that enable us to
commercialize novel products that can change the lives of people
suffering from debilitating chronic conditions.
Our commercial strategy for BELBUCA is to further drive continued
adoption in the large long-acting opioid market based on its unique
profile coupled with growing physician interest, policy tailwinds,
and expanding payer access. We aim to leverage the specialized
commercial infrastructure we established for BELBUCA as a vehicle
to enable commercial growth in Symproic, which is increasingly seen
as a complementary asset.
Our Products
Our product portfolio currently consists of four products that are
approved by the FDA. Three of our products utilize our patented
BioErodible MucoAdhesive (“BEMA") thin film drug-delivery
technology.
BELBUCA
BELBUCA® (buprenorphine buccal film), CIII is a buccal film that
contains the Schedule III opioid buprenorphine, which was approved
by the FDA in October 2015 for use in patients with pain severe
enough to require daily, around-the-clock, long-term opioid
treatment for which alternative options are inadequate. BELBUCA is
differentiated from other opioids and has the potential to address
some of the most critical issues facing healthcare providers
treating chronic pain with prescription opioids – abuse, misuse,
addiction, and the risk of overdose. Compared to currently marketed
products and products under development, we believe that BELBUCA is
differentiated based on the following features:
•strong
and durable efficacy in both opioid naïve and opioid experienced
patients;
•Schedule
III designation by DEA, which indicates less abuse and addiction
potential compared to Schedule II opioids, which include oxycodone,
hydrocodone and morphine;
•in
published studies, investigators observed that respiratory
depression from buprenorphine administration reached a plateau, and
we believe this ceiling effect may result in a lower risk of
overdose death related to respiratory depression;
•favorable
tolerability with a low incidence of constipation and low
discontinuation rate;
•flexible
dosing options with seven available strengths; and
•buccal
administration to optimize drug bioavailability.
We believe that there are long-term growth opportunities for
BELBUCA, and we focus our commercial efforts primarily on BELBUCA.
Our sales force is focused on current BELBUCA prescribers, chronic
pain management specialists, and clinicians we believe have the
greatest opportunity to be adopters of BELBUCA. As of October 2020,
BELBUCA had formulary coverage for more than 94% of commercial
lives.
Additionally, we recently completed a Phase I placebo-controlled
study to compare the effects of BELBUCA and oral oxycodone
hydrochloride (a full μ-opioid receptor agonist) on respiratory
drive, as measured by the ventilatory response to hypercapnia (VRH)
after drug administration. While analyses of the data is currently
ongoing, our primary endpoint showed
that there was no significant change in respiratory drive compared
to placebo for any dose of BELBUCA (300, 600, or 900 mcg) and there
was a dose-dependent worsening of respiratory drive compared to
placebo for oxycodone, and it was statistically significant at the
60mg dose.
The risks to our company associated with BELBUCA include: (i)
inability to continue to manufacture adequate supplies for
commercial use; (ii) unexpected product safety issues; (iii)
failure of our sales force to effectively sell the product and,
(iv) inadequate reimbursement. A technical or commercial failure of
BELBUCA would have a material adverse effect on our future revenue
potential and would negatively affect investor confidence in our
company and our public stock price.
SYMPROIC
Symproic® is a peripherally acting mu-opioid receptor antagonist
("PAMORA"), and was approved by the FDA on March 23, 2017 for the
treatment of opioid-induced constipation ("OIC") in adult patients
with chronic non-cancer pain, including patients with chronic pain
related to prior cancer or its treatment who do not require
frequent (e.g., weekly) opioid dosage escalation. OIC occurs
primarily via activation of enteric mu-receptors in the small
intestine and proximal colon, which results in harder stool and
less frequent and less effective defecation. Because OIC results
from the specific effects of opioids, it differs mechanistically
from other forms of constipation, and deserves dedicated medical
management. Compared to currently marketed products and products
under development for OIC, we believe that Symproic is
differentiated based on the following features:
•strong
and durable efficacy observed in randomized, double-blind, placebo
controlled clinical trials of 12-weeks and 52-weeks duration in OIC
patients;
•OIC
relief that was more frequent, more complete, and with less
straining than patients taking placebo;
•recommended
by the American Gastroenterological Association for patients with
laxative refractory OIC;
•adverse
event profile comparable to placebo, with low rates of abdominal
pain observed across the Phase III program; and
•the
only prescription OIC medication with the convenience of once-daily
dosing, with only one tablet strength, and that can be taken with
or without food and with or without laxatives.
Because of the durable efficacy, tolerability and convenience
benefits, we believe that Symproic is a best-in-class PAMORA that
reliably provides durable relief of OIC, which allows both the
patient and the healthcare provider to focus on managing the issue
of chronic pain.
We believe that there are long-term growth opportunities for
Symproic. According to data from Symphony Health, in 2019 Symproic
prescription volume grew over 60%, capturing 10% of the PAMORA
market. In 2019 the PAMORA market declined by 3%, with over 585,000
PAMORA prescriptions dispensed. The growth rate of the PAMORAs has
slowed, driven by a decline in opioid prescription rates. As of
January 2020, Symproic had formulary coverage for more than 95% of
commercial lives.
The risks to our company associated with Symproic include: (i)
unexpected product safety issues; (ii) inability to continue to
supply product in adequate quantities to meet the commercial
demand; (iii) inability to manufacture adequate supplies for
commercial use; (iv) failure of our sales force to effectively sell
the product, (v) inadequate reimbursement, and (vi) a possible
decrease in the OIC market.
BUNAVAIL
In June 2014, BUNAVAIL® (buprenorphine and naloxone buccal film)
was approved by the FDA for the maintenance treatment of opioid
dependence as part of a complete treatment plan to include
counseling and psychosocial support. BUNAVAIL contains the partial
opioid agonist buprenorphine, which binds to the same receptors as
opiate drugs but has a higher affinity, and naloxone, an opioid
antagonist, and an abuse deterrent. The Company discontinued all
marketing of BUNAVAIL in August 2020.
ONSOLIS
In July 2009, ONSOLIS® (fentanyl buccal soluble film) was approved
for the management of pain that “breaks through” the effects of
other medications being used to control persistent pain, or
breakthrough pain, in cancer patients 18 years of age and older who
are already receiving and who are tolerant to opioid therapy for
their underlying persistent cancer pain. We refer to breakthrough
cancer pain in opioid tolerant patients as BTCP. ONSOLIS provides
significant reduction in pain for patients suffering from BTCP in a
convenient formulation with a range of doses to allow patients to
titrate to an adequate level of pain control. We are not currently
assessing options for U.S. commercialization of ONSOLIS. Given the
current declining market
conditions, we have no plans to introduce the product in the U.S.
at this time. The product is no longer a strategic asset for the
Company.
We will continue to seek additional license agreements. We
anticipate that funding for the next several years will come
primarily from earnings from sales of BELBUCA and Symproic, and
milestone payments and royalties from Mylan and TTY.
Results of Operations
Comparison of the three months ended September 30, 2020 and
2019
Product Sales.
We recognized $38.8 million and $29.6 million in product sales
during the three months ended September 30, 2020 and 2019,
respectively. The increase in 2020 is principally due to BELBUCA
and Symproic product sales which have been driven by increased paid
prescriptions from the utilization of managed care wins, along with
growth in the Medicare channel, and offset by lower BUNAVAIL
product sales resulting from our discontinuation of marketing
activities. While BELBUCA gross to net deductions did increase in
the third quarter as anticipated, based primarily on typical
increases seen for coverage gap along with increased Medicaid
costs, those increases were favorably impacted by updates to our
channel estimates reflected in the third quarter of 2020. BUNAVAIL
net revenue in the quarter reflects the release of a portion of the
returns reserves taken at the time discontinuation was
announced.
Product Royalty Revenues.
We recognized $0.7 million in product royalty revenue during each
of the three months ended September 30, 2020 and 2019,
respectively, related to PAINKYL royalty revenue under our license
agreement with TTY.
Cost of Sales.
We incurred $5.4 million in cost of sales during each of the three
months ended September 30, 2020 and 2019, respectively. Cost of
sales includes product cost, royalties paid, depreciation, yield
adjustments and quarterly minimum royalty payments to CDC IV, LLC
(“CDC”).
Selling, General and Administrative Expenses.
During the three months ended September 30, 2020 and 2019, selling,
general and administrative expenses totaled $22.5 million and $23.4
million, respectively. Selling, general and administrative costs
include all costs not related to the manufacturing of product. The
decrease in selling, general and administrative expenses during the
three months ended September 30, 2020 as compared to the same
period in the prior year is primarily due to lower spend associated
with cost management measures that have been put in place in
response to Covid-19, particularly over select marketing programs.
In addition, we have continued to see a reduction in travel
expenses due to elimination of live presence at conferences and
restrictions in visiting doctor's offices.
Interest expense, net .
During the three months ended September 30, 2020, we had net
interest expense of $2.0 million, which consisted of $1.9 million
of scheduled interest payments, and $0.1 million of amortization of
discount and loan costs.
During the three months ended September 30, 2019, we had net
interest expense of $1.2 million, which includes interest expense
of $1.5 million and $0.06 million of amortization of discount and
loan costs. During the three months ended September 30, 2019, we
also had interest income of $0.3 million.
Comparison of the nine months ended September 30, 2020 and
2019
Product Sales.
We recognized $112.9 million and $77.4 million in product sales
during the nine months ended September 30, 2020 and 2019,
respectively. The increase in 2020 is principally due to
increased BELBUCA and Symproic product sales from higher patient
utilization, the impact of managed care wins, the impact of our
price increase on January 1, 2020, and the full period impact of
Symproic, partially offset by lower BUNAVAIL product
sales.
Product Royalty Revenues.
During the nine months ended September 30, 2020 and 2019, we
recognized $1.4 million and $2.2 million in PAINKYL and BREAKYL
product royalty revenue under our license agreements with TTY and
Mylan, respectively. Product royalty revenue related to PAINKYL and
BREAKYL is primarily via government demand in the Ex-U.S. countries
where the products are sold by TTY and Mylan,
respectively.
Contract Revenues.
We recognized $0.2 million in contract revenues during the nine
months ended September 30, 2019 related to our license agreements
TTY. There were no such contract revenues during the same period of
2020.
Cost of Sales.
We incurred $16.4 million and $14.3 million in cost of sales during
the nine months ended September 30, 2020 and 2019,
respectively. Cost of sales includes product cost, royalties
paid, depreciation, yield adjustments and quarterly minimum royalty
payments to CDC. Cost of sales for the nine months ended
September 30, 2020 includes a $0.3 million one-time
depreciation charge due to BUNAVAIL equipment
write-off.
Selling, General and Administrative Expenses.
During the nine months ended September 30, 2020 and 2019, selling,
general and administrative expenses totaled $77.4 million and
$62.3 million, respectively. Selling, general and
administrative
costs include all other costs not connected to the manufacturing of
product. The increase in selling, general and administrative
expenses during the nine months ended September 30, 2020 is due
primarily to increased marketing efforts during the first quarter
2020, higher legal costs, and severance costs associated with the
termination of the former CEO. These increased costs have been
partially offset by cost management measures that were put in place
during the second quarter of 2020 in response to the pandemic, such
as reductions in select marketing programs as well as a significant
reduction in travel expenses resulting from the various "stay at
home" orders across the country.
Interest expense, net.
During the nine months ended September 30, 2020, we had net
interest expense of $5.0 million, which includes interest
expense of $5.0 million and $0.2 million of amortization
of discount and loan costs. During the nine months ended September
30, 2020, we also had interest income of
$0.2 million.
During the nine months ended September 30, 2019, we had net
interest expense of $17.7 million, consisting of $11.9 million
of one-time costs associated with the refinancing of our term loan
in May 2019, $5.3 million of scheduled interest payments relating
to both loans, $0.1 million of related amortization of discount and
loan costs for both the old and new debt arrangements, and $0.4
million of warrant interest expense associated with the former CRG
loan. During the nine months ended September 30, 2019, we also had
interest income of $0.6 million.
The one-time expenses related to the payoff of the CRG loan in May
2019 consisted of $5.2 million in unamortized deferred loan fees,
$3.9 million in unamortized warrant discount costs and $2.8 million
in loan prepayment fees and realized losses, for a cumulative total
of $11.9 million in one-time costs.
Trends and Uncertainties
Potential Impact of the COVID-19 Pandemic
The recent COVID-19 pandemic is understood to have originated in
Wuhan, China in December 2019 and has since spread globally,
including to the United States and European countries. The
continued spread of COVID-19 has adversely impacted our operations,
including our efforts to market BELBUCA and Symproic. Any decrease
in sales or interruption in supply of any of our products could
increase our operating expenses and have a material adverse effect
on our business and financial results.
In addition, COVID-19 has resulted in significant governmental
measures being implemented to control the spread of the virus,
including quarantines, travel restrictions, social distancing and
business shutdowns. We have taken temporary precautionary measures
intended to help minimize the risk of the virus to our employees,
including temporarily requiring all home-office employees to work
remotely. We have suspended non-essential travel worldwide for our
employees and are discouraging employee attendance at other
gatherings. These measures could negatively affect our business.
For instance, temporarily requiring all employees to work remotely
may induce absenteeism, disrupt our operations or increase the risk
of a cybersecurity incident. COVID-19 has also caused volatility in
the global financial markets and threatened a slowdown in the
global economy, which may negatively affect our ability to raise
additional capital on attractive terms or at all.
In addition, a recurrence or "second wave" of COVID-19 cases could
cause other widespread or more severe impacts depending on where
infection rates are highest. The extent to which COVID-19 will
continue to impact our business will depend on future developments,
which are highly uncertain and cannot be predicted with confidence,
such as the duration of the pandemic, the severity of COVID-19 or
the effectiveness of actions to contain and treat COVID-19,
particularly in the geographies where we or our third party
suppliers and contract manufacturers or contract research
organizations operate. If we or any of the third parties with whom
we engage experience shutdowns or other business disruptions, our
ability to conduct our business in the manner and on the timelines
presently planned could be materially and negatively affected,
which could have a material adverse impact on our business and our
results of operations and financial condition.
Non-GAAP Financial Information:
We report our condensed consolidated financial results in
accordance with GAAP; however, we believe that earnings before
interest, taxes, depreciation and amortization (“EBITDA”) and other
non-GAAP results should not be considered in isolation of or as an
alternative for, earnings measures prepared in accordance with
GAAP. Management uses these non-GAAP measures internally to measure
the ongoing operating performance of our Company along with other
metrics, and for planning and forecasting purposes. In addition,
when evaluating non-GAAP results, we exclude certain items that are
considered to be non-cash and if applicable, non-recurring, in
nature.
EBITDA and Non-GAAP Income/(Loss):
We have presented EBITDA because it is a key measure used by
our management and board of directors to understand and evaluate
our operating performance and to develop operational goals for
managing our business. We believe this financial
measure helps identify underlying trends in our business that could
otherwise be masked by the effect of the expenses that we exclude.
In particular, we believe that the exclusion of the expenses
eliminated in calculating EBITDA can provide a useful measure
for period-to-period comparisons of our core operating performance.
Accordingly, we believe that EBITDA provides useful
information to investors and others in understanding and evaluating
our operating results, enhancing the overall understanding of our
past performance and future prospects, and allowing for greater
transparency with respect to key financial metrics used by our
management in its financial and operational
decision-making.
EBITDA is not prepared in accordance with GAAP, and should not
be considered in isolation of, or as an alternative to, measures
prepared in accordance with GAAP. There are a number of limitations
related to the use of EBITDA rather than net income/(loss),
which is the nearest GAAP equivalent. Some of these limitations
are:
•EBITDA excludes
depreciation and amortization and, although these are non-cash
expenses, the assets being depreciated or amortized may have to be
replaced in the future, the cash requirements for which are not
reflected in EBITDA;
•EBITDA does
not reflect provision for (benefit from) income taxes or the cash
requirements to pay taxes; and
•EBITDA
excludes net interest, including both interest expense and interest
income.
Non-GAAP net income/(loss) is an alternative view of our
performance that we are providing because management believes this
information enhances investors’ understanding of our results as it
permits investors to better understand the ongoing operations of
the business, the impact of any non-recurring one-time events, the
cash results of the organization and is an additional measure used
by management to assess performance.
Non-GAAP net income/(loss) is not prepared in accordance with
GAAP, and should not be considered in isolation of, or as an
alternative to, measures prepared in accordance with GAAP. There
are a number of limitations related to the use of non-GAAP net
income/(loss) rather than net income/(loss), which is the nearest
GAAP equivalent. Some of these limitations are:
•The
expenses and other items that we exclude in our calculation of
non-GAAP net income/(loss) may differ from the expenses and
other items, if any, that other companies may exclude from non-GAAP
net income/(loss) when they report their operating results
since non-GAAP income/(loss) is not a measure determined in
accordance with GAAP, and it has no standardized meaning prescribed
by GAAP;
•We
exclude stock-based compensation expense from non-GAAP net
income/(loss) although (a) it has been, and will likely
continue to be for the foreseeable future, a significant recurring
expense for our business and an important part of our compensation
strategy and (b) if we did not pay out a portion of our
compensation in the form of stock-based compensation, the cash
salary expense included in operating expenses would likely be
higher, which would affect our cash position;
•We
exclude amortization of intangible assets from non-GAAP net
income/(loss) due to the non-cash nature of this expense and
although it has been and will continue to be for the foreseeable
future a recurring expense for our business, these expenses do not
affect our cash position; and
•We
exclude the financial impact of debt refinancing, the CEO
termination costs and the BUNAVAIL equipment write-off, because
they are each non-recurring in nature.
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
Reconciliation of GAAP net income/(loss) to EBITDA
(non-GAAP) |
2020 |
2019 |
|
2020 |
2019 |
GAAP net income/(loss) |
$ |
9,383 |
|
$ |
354 |
|
|
$ |
15,515 |
|
$ |
(14,609) |
|
Add back/(subtract): |
|
|
|
|
|
Income tax provision |
211 |
|
4 |
|
|
19 |
|
4 |
|
Net interest expense |
2,012 |
|
1,237 |
|
|
4,991 |
|
17,727 |
|
Depreciation and amortization |
1,754 |
|
1,904 |
|
|
5,715 |
|
5,259 |
|
EBITDA |
$ |
13,360 |
|
$ |
3,499 |
|
|
$ |
26,240 |
|
$ |
8,381 |
|
Reconciliation of GAAP net income/(loss) to Non-GAAP net
income/(loss) |
|
|
|
|
|
GAAP net income/(loss) |
$ |
9,383 |
|
$ |
354 |
|
|
$ |
15,515 |
|
$ |
(14,609) |
|
Non-GAAP adjustments: |
|
|
|
|
|
Stock-based compensation expense |
1,473 |
|
1,267 |
|
|
4,424 |
|
3,978 |
|
Amortization of intangible assets |
1,734 |
|
1,898 |
|
|
5,248 |
|
5,084 |
|
Amortization of warrant discount |
— |
|
— |
|
|
— |
|
448 |
|
Non-recurring financial impact of debt refinance |
— |
|
— |
|
|
— |
|
11,866 |
|
Non-recurring financial impact of CEO transition |
67 |
|
— |
|
|
5,078 |
|
— |
|
Non-recurring financial impact of BUNAVAIL
discontinuation |
— |
|
— |
|
|
295 |
|
— |
|
Non-GAAP net income/(loss) |
$ |
12,657 |
|
$ |
3,519 |
|
|
$ |
30,560 |
|
$ |
6,767 |
|
Liquidity and Capital Resources
Since inception, we have financed our operations principally from
the sale of equity securities, proceeds from borrowings,
convertible notes, and notes payable, funded research arrangements,
revenue generated as a result of our worldwide license and
development agreements and the commercialization of our BELBUCA,
Symproic and BUNAVAIL products. We intend to finance our
commercialization and working capital needs from existing cash,
earnings from the commercialization of BELBUCA and Symproic,
royalty revenue, new sources of debt and equity financing, existing
and new licensing and commercial partnership agreements and,
potentially, through the exercise of outstanding common stock
options and warrants to purchase common stock.
At September 30, 2020, we had cash and cash equivalents of
approximately $100.2 million. We generated $14.0 million of cash in
operations during the nine months ended September 30, 2020 . We
believe that we have sufficient cash to manage the business as
currently planned.
Additional capital may be required to support the continued
commercialization of our BELBUCA and Symproic products, or other
products which may be acquired or licensed by us, and for general
working capital requirements. Based on agreements with our
partners, the ability to scale up or reduce personnel and
associated costs are factors considered throughout the product life
cycle. Available resources may be consumed more rapidly than
currently anticipated, potentially resulting in the need for
additional funding.
Accordingly, we anticipate that we may be required to raise
additional capital, which may be available to us through a variety
of sources, including:
•public
equity markets;
•private
equity financings;
•commercialization
agreements and collaborative arrangements;
•sale
of product royalty;
•grants
and new license revenues;
•bank
loans;
•equipment
financing;
•public
or private debt; and
•exercise
of existing warrants and options.
Readers are cautioned that additional funding, capital or loans
(including, without limitation, milestone or other payments from
commercialization agreements) may be unavailable on favorable
terms, if at all. If adequate funds are not available, we may be
required to significantly reduce or refocus our operations or to
obtain funds through arrangements that may require us to relinquish
rights to certain technologies and drug formulations or potential
markets, either of which could have a material adverse effect on
us, our financial condition and our results of operations in 2020
and beyond. To the extent that additional capital is raised through
the sale of equity or convertible debt securities, the issuance of
such securities would result in ownership dilution to existing
stockholders.
Contractual Obligations and Commercial Commitments
Our contractual obligations as of September 30, 2020 are as
follows in thousands:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
Total |
Less than
1 year |
1-3 years |
3-5 years |
More than
5 years |
Lease obligations |
$ |
681 |
|
$ |
368 |
|
$ |
313 |
|
$ |
— |
|
$ |
— |
|
Secured loan facility |
80,000 |
|
— |
|
36,923 |
|
43,077 |
|
— |
|
Interest on secured loan facility |
25,049 |
|
7,706 |
|
13,186 |
|
4,157 |
|
— |
|
Minimum royalty expenses* |
10,125 |
|
1,500 |
|
3,000 |
|
3,000 |
|
2,625 |
|
Purchase obligations** |
958 |
|
804 |
|
154 |
|
— |
|
— |
|
Total contractual cash obligations |
$ |
116,813 |
|
$ |
10,378 |
|
$ |
53,576 |
|
$ |
50,234 |
|
$ |
2,625 |
|
* Minimum royalty expenses represent a
contractual floor that we are obligated to pay CDC and NB Athyrium
LLC regardless of actual sales. The minimum payment is
$0.4 million per quarter or $1.5 million per year until
patent expiry on July 23, 2027.
** Purchase obligations represent an
agreement for the supply of active pharmaceutical ingredient for
use in production.
Off-Balance Sheet Arrangements
As of September 30, 2020, we had no off-balance sheet
arrangements.
Effects of Inflation
We do not believe that inflation has had a material effect on our
financial position or results of operations. However, there can be
no assurance that our business will not be affected by inflation in
the future.
Critical Accounting Policies
For information regarding our critical accounting policies and
estimates, please refer to “Management’s Discussion and Analysis of
Financial Condition and Results of Operations – Critical Accounting
Policies and Estimates” contained in our annual report on Form 10-K
for the year ended December 31, 2019.
Item 3. Quantitative and Qualitative
Disclosures About Market Risk
Interest rate risk
Our cash includes all highly liquid investments with an original
maturity of three months or less. Because of the short-term
maturities of our cash, we do not believe that an increase in
market rates would have a significant impact on the realized value
of our investments. We place our cash on deposit with financial
institutions in the U.S. The Federal Deposit Insurance Corporation
covers $0.25 million for substantially all depository accounts. As
of September 30, 2020, we had approximately
$100.3 million, which exceeded these insured
limits.
Foreign currency exchange risk
We currently have, and may in the future have increased,
commercial, manufacturing and clinical agreements which are
denominated in Euros or other foreign currencies. As a result, our
financial results could be affected by factors such as a change in
the foreign currency exchange rate between the U.S. dollar or Euro
or other applicable currencies, or by weak economic conditions in
Europe or elsewhere in the world. Such amounts are currently
immaterial to our financial position or results of operations. We
are not currently engaged in any foreign currency hedging
activities.
Market Risk
We do not engage in speculative transactions nor do we hold or
issue financial instruments for trading purposes. In connection
with the recapitalization of our business, we have entered into a
secured credit facility consisting of a term loan. Our term loan
note bears interest which includes fluctuating interest rates based
on LIBOR.
There is currently uncertainty around whether LIBOR will continue
to exist after 2021. However, if LIBOR ceases to exist, we will not
be required to renegotiate our loan documents with our current
lender.
Item 4. Controls and
Procedures
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report, our
management, with the participation of our Interim Chief Executive
Officer (our principal executive officer) and Chief Financial
Officer (our principal financial officer) (the “Certifying
Officers”), conducted evaluations of our disclosure controls and
procedures. As defined under Sections 13a-15(e) and 15d-15(e) of
the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), the term “disclosure controls and procedures” means controls
and other procedures of an issuer that are designed to ensure that
information required to be disclosed by the issuer in the reports
that it files or submits under the Exchange Act is recorded,
processed, summarized and reported, within the time periods
specified in the rules and forms of the SEC. Disclosure controls
and procedures include without limitation, controls and procedures
designed to ensure that information required to be disclosed by an
issuer in the reports that it files or submits under the Exchange
Act is accumulated and communicated to the issuer’s management,
including the Certifying Officers, to allow timely decisions
regarding required disclosures.
Readers are cautioned that our management does not expect that our
disclosure controls and procedures or our internal control over
financial reporting will necessarily prevent all fraud and material
error. An internal control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that
the objectives of the control system are met. Because of the
inherent limitations in all control systems, no evaluation of
controls can provide absolute assurance that all control issues and
instances of fraud, if any, within our control have been detected.
The design of any system of controls also is based in part upon
certain assumptions about the likelihood of future events, and
there can be no assurance that any control design will succeed in
achieving its stated goals under all potential future conditions.
Over time, controls may become inadequate because of changes in
conditions, or the degree of compliance with the policies or
procedures may deteriorate.
Based on this evaluation, the Certifying Officers have concluded
that our disclosure controls and procedures were effective as of
September 30, 2020.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial
reporting during our third quarter of 2020 that materially
affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
Certain information set forth in this Quarterly Report on Form
10-Q, including in Item 2, “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” (and the “Liquidity
and Capital Resources” section thereof) and elsewhere may address
or relate to future events and expectations and as such constitutes
“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 our plans, objectives, projections, expectations and intentions
and other statements identified by words such as “projects,” “may,”
“could,” “would,” “should,” “believes,” “expects,” “anticipates,”
“estimates,” “will,” “potential,” “intends,” “plans” or similar
expressions. These statements are based upon the current beliefs
and expectations of our management and are subject to significant
risks and uncertainties, including those detailed in our filings
with the U.S. Securities and Exchange Commission. Actual results,
including, without limitation: (i) actual sales results (including
the results of our continuing commercial efforts with BELBUCA and
Symproic), (ii) the application and availability of corporate funds
and our need for future funds, (iii) the FDA’s review of our
products and any regulatory filings related thereto, or (iv) the
results of our ongoing intellectual property litigations and patent
office proceedings, may differ materially from those set forth or
implied in the forward-looking statements. Such forward-looking
statements also involve other factors which may cause our actual
results, performance or achievements to materially differ from any
future results, performance, or achievements expressed or implied
by such forward-looking statements and to vary significantly from
reporting period to reporting period. Such factors include, among
others, the impact of the COVID-19 pandemic on our business and
results of operations, those listed under Item 1A of our most
recent Annual Report on Form 10-K filed with the SEC on March 12,
2020 and under Item 1A of this Quarterly Report on Form 10-Q and
other factors detailed from time to time in our other filings with
the U.S. Securities and Exchange Commission. Although management
believes that
the assumptions made and expectations reflected in the
forward-looking statements are reasonable, there is no assurance
that the underlying assumptions will, in fact, prove to be correct
or that actual future results will not be different from the
expectations expressed in this Quarterly Report. We undertake 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.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
See Note 9, Commitments and Contingencies, to our condensed
consolidated financial statements included in Part I, Item I of
this Quarterly Report on Form 10-Q, which is incorporated into this
item by reference.
Item 1A. Risk Factors.
COVID-19 may materially and adversely affect our business and our
financial results.
The recent COVID-19 pandemic is understood to have originated in
Wuhan, China in December 2019 and has since spread globally,
including to the United States and European countries. The
continued spread of COVID-19 has adversely impacted our operations,
including our efforts to market BELBUCA and Symproic. Any decrease
in sales or interruption in supply of any of our products could
increase our operating expenses and have a material adverse effect
on our business and financial results.
In addition, COVID-19 has resulted in significant governmental
measures being implemented to control the spread of the virus,
including quarantines, travel restrictions, social distancing and
business shutdowns. We have taken temporary precautionary measures
intended to help minimize the risk of the virus to our employees,
including temporarily requiring all home-office employees to work
remotely. We have suspended non-essential travel worldwide for our
employees and are discouraging employee attendance at other
gatherings. These measures could negatively affect our business.
For instance, temporarily requiring all employees to work remotely
may induce absenteeism, disrupt our operations or increase the risk
of a cybersecurity incident. COVID-19 has also caused volatility in
the global financial markets and threatened a slowdown in the
global economy, which may negatively affect our ability to raise
additional capital on attractive terms or at all.
In addition, a recurrence or "second wave" of COVID-19 cases could
cause other widespread or more sever impacts depending on where
infection rates are highest. The extent to which COVID-19 will
continue to impact our business will depend on future developments,
which are highly uncertain and cannot be predicted with confidence,
such as the duration of the pandemic, the severity of COVID-19 or
the effectiveness of actions to contain and treat COVID-19,
particularly in the geographies where we or our third party
suppliers and contract manufacturers or contract research
organizations operate. If we or any of the third parties with whom
we engage experience shutdowns or other business disruptions, our
ability to conduct our business in the manner and on the timelines
presently planned could be materially and negatively affected,
which could have a material adverse impact on our business and our
results of operations and financial condition.
Item 2. Unregistered Sales of Equity
Securities and Use of Proceeds.
On November 4, 2020, the Board of Directors authorized the
repurchase of up to $25 million of the Company's shares of Common
Stock. The timing and amount of any shares purchased on the open
market will be determined based on the Company's evaluation of
market conditions, share price and other factors. The Company plans
to utilize existing cash on hand to fund the share repurchase
program.
Item 3. Defaults upon Senior
Securities.
None.
Item 4. Mine Safety
Disclosures.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits.
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Number |
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Description |
31.1 |
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31.2 |
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32.1 |
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32.2 |
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101.ins |
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XBRL Instance Document. |
101.sch |
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XBRL Taxonomy Extension Schema Document. |
101.cal |
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XBRL Taxonomy Calculation Linkbase Document. |
101.def |
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XBRL Taxonomy Definition Linkbase Document. |
101.lab |
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XBRL Taxonomy Label Linkbase Document. |
101.pre |
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XBRL Taxonomy Presentation Linkbase Document. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL
document contained in Exhibit 101).* |
*Filed herewith, a signed original of this written statement
required by Section 906 has been provided to the Company and
will be retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request.
#This certification will 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 liability of that
section. Such certification will not be deemed to be incorporated
by reference into any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except to the extent specifically
incorporated by reference into such filing.
SIGNATURES
Pursuant to the requirements of the Exchange Act, the registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
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BIODELIVERY SCIENCES INTERNATIONAL, INC. |
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Date: November 5, 2020 |
By: |
/s/ Jeffrey Bailey |
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Jeffrey Bailey |
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Director and Chief Executive Officer |
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(Principal Executive Officer) |
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Date: November 5, 2020 |
By: |
/s/ Mary Theresa Coelho |
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Mary Theresa Coelho |
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Treasurer and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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