BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a
rapidly growing specialty pharmaceutical company dedicated to
patients living with serious and complex chronic conditions, today
reported strong financial results for the fourth quarter and
full-year ended December 31, 2019, as well as the following
operational and performance highlights.
Key Business Highlights
- Total Company full-year net sales of $111.4 million delivered
growth of 100% versus 2018 and was driven by
BELBUCA® (buprenorphine buccal film), CIII net sales of $97.5
million, an increase of 112% compared to 2018, and the addition of
Symproic® (naldemedine) tablets 0.2mg to the commercial portfolio,
which delivered $8.1 million net sales in 2019.
- Total Company net revenue for the fourth quarter increased by
75% versus the prior year period to a new all-time high
of $31.6 million. This growth was driven by
BELBUCA sales of $28.3 million, an increase of 78% versus the
prior year period, and the addition of Symproic to the commercial
portfolio.
- Total BELBUCA prescriptions of more than 96,000 for the fourth
quarter were the highest ever for any three-month period,
representing year-over-year prescription volume growth of more than
70% in the quarter.
- Total Symproic prescriptions reached an all-time high of 16,555
in the fourth quarter, representing more than 36% growth versus the
prior year period.
- Achieved record number of unique prescribers during the quarter
for both BELBUCA and Symproic.
- In addition, as previously released, the Company recently
presented the positive results from the BELBUCA Phase I respiratory
drive study at the American Academy of Pain Medicine’s (AAPM) 36th
Annual Meeting.
“I am very pleased by the continued strong execution during the
fourth quarter, culminating in a very successful and transformative
year for the Company in 2019,” stated Herm Cukier, CEO of BDSI.
“The continued growth of BELBUCA and Symproic, in addition to the
commercial and scientific plans we have developed, position us for
long-term sustained success. We continue to monitor the
COVID-19 pandemic for any potential impact which may arise in this
rapidly evolving situation, and remain focused on bringing
important clinical value to patients.”
Fourth Quarter 2019 Financial Results
Total Company Net Revenue for the fourth
quarter of 2019 was $31.6 million, an increase of 75% compared to
$18.0 million in the fourth quarter of 2018, and an increase of 4%
compared to $30.3 million in the third quarter of 2019.
BELBUCA Net Sales for the fourth quarter of
2019 were $28.3 million, an increase of 78% compared to $15.9
million in the fourth quarter of 2018, and an increase of 7%
compared to $26.5 million in the third quarter of 2019.
Symproic Net Sales for the fourth quarter were
$2.7 million, an increase of 25% compared to $2.2 million in the
third quarter of 2019.
BUNAVAIL Net Sales for the fourth quarter were
($0.5) million, a reduction of 141.7% compared to $1.2 million in
the fourth quarter of 2018. Net sales for the fourth quarter
of 2019 reflect $2.3 million of one-time additional revenue related
reserves in connection with the March 2020 announcement of the
discontinuation of marketing of BUNAVAIL.
Product Royalty Revenue for the fourth quarter
was $1.2 million, an increase of $0.2 million compared to $1.0
million in the fourth quarter of 2018 and an increase of $0.5
million compared to the third quarter of 2019.
Total Operating Expenses for the fourth quarter
of 2019 were $23.8 million, compared to $23.4 million in the third
quarter of 2019 and $18.5 million in the fourth quarter of
2018.
GAAP Net Loss for the fourth quarter of
2019 was $0.7 million compared to GAAP net income of $0.4 million
for the third quarter of 2019 and GAAP net loss of $7.0 million in
the fourth quarter of 2018.
EBITDA in the fourth quarter of 2019 was $4.1
million, or 13.0% of net sales, compared to $3.5 million in the
third quarter of 2019 and ($3.0) million in the fourth quarter of
2018.
Non-GAAP Net Income for the quarter was $6.4
million and reflects GAAP net income excluding stock-based
compensation, non-cash amortization of intangible assets, and the
non-recurring financial impact of $3.8 million related to the
discontinuation of marketing of BUNAVAIL.
Full-Year 2019 Financial Results
Total Net Revenue for full-year 2019 was $111.4
million, an increase of 100% compared to $55.6 million for
full-year 2018.
BELBUCA Net Sales for full-year 2019 were $97.5
million, an increase of 112% compared to $46.0 million for
full-year 2018.
Symproic Net Sales for full-year 2019 were $8.1
million, reflecting three quarters of sales during 2019.
BUNAVAIL Net Sales for full-year 2019 were $2.3
million, a reduction of 57.4% compared to $5.4 million for
full-year 2018.
Product Royalty Revenue for full-year 2019 was
$3.5 million, compared to $4.2 million for full-year 2018.
Total Operating Expenses for full-year 2019
were $86.1 million, compared to $63.5 million for full-year
2018.
GAAP Net Loss for full-year 2019 was $15.3
million compared to GAAP net loss of $33.9 million for full-year
2018.
EBITDA for full-year of 2019 was $12.5 million,
or 11.2% of net sales compared to ($17.5) million, or (31.4)% of
net sales for full-year 2018.
Non-GAAP Net Income for full-year 2019 was
$13.2 million and reflects GAAP net income excluding stock-based
compensation, non-cash amortization of intangible assets and
certain warrant discount costs, one-time expenses related to
our debt refinancing in May 2019, and the non-recurring
financial impact related to the discontinuation of the marketing of
BUNAVAIL.
Cash Position: As of December 31, 2019, cash
and cash equivalents were approximately $63.9 million, compared to
cash and cash equivalents of $43.8 million as of December 31, 2018,
and $55.9 million in the third quarter of 2019, reflecting positive
cash flow of $8.0 million in the fourth quarter of 2019, and $20.1
million for full-year 2019.
Conference Call & Webcast Details
BioDelivery Sciences will host a conference call and
webcast today, March 12, 2020, at 4:30 p.m. ET to
present fourth quarter 2019 results and to provide a business
update. Dial-in details are as follows:
Date: |
Thursday, March 12, 2020 |
Time: |
4:30 PM EST |
Domestic: |
877-407-0789 |
International: |
201-689-8562 |
Conference ID: |
13699178 |
Webcast: |
http://public.viavid.com/index.php?id=138131 |
ABOUT BIODELIVERY SCIENCES INTERNATIONAL,
INC.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a
commercial-stage specialty pharmaceutical company dedicated to
patients living with chronic conditions. BDSI has built a portfolio
of products that includes utilizing its novel and proprietary
BioErodible MucoAdhesive (BEMA®) technology to develop and
commercialize, either on its own or in partnership with third
parties, new applications of proven therapies aimed at addressing
important unmet medical needs. BDSI's marketed products address
serious and debilitating conditions, including chronic pain, opioid
dependence, and opioid-induced constipation.
CAUTIONARY NOTE ON FORWARD-LOOKING
STATEMENTS
This press release and any statements of
employees, representatives, and partners of BioDelivery
Sciences International, Inc. (“BDSI”) related thereto contain,
or may contain, among other things, certain “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements involve
significant risks and uncertainties. Such statements may include,
without limitation, statements with respect to BDSI’s plans,
objectives, projections, expectations and intentions and other
statements identified by words such as “projects,” “may,” “will,”
“could,” “would,” “should,” “believes,” “expects,” “anticipates,”
“estimates,” “intends,” “plans,” “potential” or similar
expressions. These statements are based upon the current beliefs
and expectations of BDSI’s management and are subject to
significant risks and uncertainties, including those detailed in
BDSI’s filings with the Securities and Exchange Commission.
Actual results (including, without limitation, the continued growth
in BELBUCA net sales and total company net revenue in 2020 may
differ materially from those set forth or implied in the
forward-looking statements. These forward-looking statements
involve certain risks and uncertainties that are subject to change
based on various factors (many of which are beyond BDSI’s control)
including the risk that the current coronavirus pandemic impacts on
our supply chain, commercial partners, patients and their
physicians and the healthcare facilities in which they work, and
our personnel are greater than we anticipate, as well as those set
forth in our 2019 annual report on Form 10-K filed with the US
Securities and Exchange Commission and subsequent filings.
BDSI undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future presentations or otherwise, except as required by applicable
law.
Non-GAAP Financial Measures
This press release includes information about certain financial
measures that are not prepared in accordance with generally
accepted accounting principles in the United States, or GAAP,
including non-GAAP net income and EBITDA. These non-GAAP measures
are not based on any standardized methodology prescribed by GAAP
and are not necessarily comparable to similar measures presented by
other companies.
Non-GAAP net income adjusts for one-time and non-cash charges by
excluding the following from GAAP net income: stock-based
compensation expense, amortization of intangible assets,
amortization of certain warrant discount costs, and the financial
impact of certain one-time items that are non-recurring, including
our debt refinancing in May 2019 and the discontinuation of
marketing of BUNAVAIL.
EBITDA excludes net interest, including both interest expenses
and interest income, provision for (benefit from) income taxes and
depreciation and amortization.
The Company's management and board of directors utilize these
non-GAAP financial measures to evaluate the Company's performance.
The Company provides these non-GAAP measures of the Company's
performance to investors because management believes that these
non-GAAP financial measures, when viewed with the Company's results
under GAAP and the accompanying reconciliations, are useful in
identifying underlying trends in ongoing operations. However,
non-GAAP net income and EBITDA are not measures of financial
performance under GAAP and, accordingly, should not be considered
as alternatives to GAAP measures as indicators of operating
performance. Further, non-GAAP net income and EBITDA should
not be considered measures of our liquidity.
A reconciliation of certain GAAP to non-GAAP financial measures
has been provided in the tables included in this press release.
© 2020 BioDelivery Sciences International,
Inc. All rights reserved.
Contact:
Tirth PatelDirector of Investor Relations(919)
582-0294tpatel@bdsi.com
BIODELIVERY SCIENCES INTERNATIONAL, INC.
AND SUBSIDIARIESCONSOLIDATED BALANCE
SHEETS(U.S. DOLLARS, IN THOUSANDS, EXCEPT SHARE
AND PER SHARE AMOUNTS)
|
December 31, |
|
2019 |
|
2018 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
63,888 |
|
|
|
$ |
43,822 |
|
|
Accounts receivable, net |
38,790 |
|
|
|
13,627 |
|
|
Inventory, net |
11,312 |
|
|
|
5,406 |
|
|
Prepaid expenses and other
current assets |
3,769 |
|
|
|
3,188 |
|
|
Total current assets |
117,759 |
|
|
|
66,043 |
|
|
Property and equipment, net |
2,075 |
|
|
|
3,072 |
|
|
Goodwill |
2,715 |
|
|
|
2,715 |
|
|
License and distribution rights,
net |
60,309 |
|
|
|
36,000 |
|
|
Other intangible assets, net |
47 |
|
|
|
703 |
|
|
Total assets |
$ |
182,905 |
|
|
|
$ |
108,533 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued
liabilities |
$ |
53,993 |
|
|
|
$ |
21,539 |
|
|
Total current liabilities |
53,993 |
|
|
|
21,539 |
|
|
Notes payable, net |
58,568 |
|
|
|
51,652 |
|
|
Other long-term liabilities |
580 |
|
|
|
5,600 |
|
|
Total liabilities |
113,141 |
|
|
|
78,791 |
|
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred Stock, 5,000,000
shares authorized; 2,714,300 shares issued; Series A Non-Voting
Convertible Preferred Stock. $0.001 par value, 2,093,155 shares
outstanding at both December 31, 2019 and December 31,
2018, respectively; Series B Non-Voting Convertible Preferred
Stock, $0.001 par value, 618 and 3,100 shares outstanding at
December 31, 2019 and December 31, 2018
respectively. |
2 |
|
|
|
2 |
|
|
Common Stock, $.001 par value;
175,000,000 and 125,000,000 shares authorized at December 31,
2019 and December 31, 2018 respectively; 96,189,074 and
70,793,725 shares issued;96,173,583 and 70,778,234 shares
outstanding at December 31, 2019 and December 31, 2018,
respectively. |
96 |
|
|
|
71 |
|
|
Additional paid-in
capital |
436,306 |
|
|
|
381,004 |
|
|
Treasury stock, at cost, 15,491
shares |
(47 |
) |
|
|
(47 |
) |
|
Accumulated deficit |
(366,593 |
) |
|
|
(351,288 |
) |
|
Total stockholders’ equity |
69,764 |
|
|
|
29,742 |
|
|
Total liabilities and
stockholders’ equity |
$ |
182,905 |
|
|
|
$ |
108,533 |
|
|
BIODELIVERY SCIENCES INTERNATIONAL, INC.
AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF
OPERATIONS(U.S. DOLLARS, IN THOUSANDS, EXCEPT
SHARE AND PER SHARE AMOUNTS)
|
Year Ended December 31, |
|
2019 |
|
2018 |
|
2017 |
Revenues: |
|
|
|
|
|
Product sales |
$ |
107,888 |
|
|
|
$ |
51,410 |
|
|
|
$ |
34,922 |
|
|
Product royalty revenues |
3,341 |
|
|
|
3,389 |
|
|
|
5,070 |
|
|
Research and development
reimbursements |
— |
|
|
|
— |
|
|
|
799 |
|
|
Contract revenue |
160 |
|
|
|
841 |
|
|
|
21,194 |
|
|
Total revenues |
111,389 |
|
|
|
55,640 |
|
|
|
61,985 |
|
|
Cost of sales |
21,590 |
|
|
|
15,783 |
|
|
|
19,496 |
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
Research and development |
— |
|
|
|
4,903 |
|
|
|
13,040 |
|
|
Selling, general and
administrative |
86,063 |
|
|
|
58,602 |
|
|
|
58,869 |
|
|
Total expenses |
86,063 |
|
|
|
63,505 |
|
|
|
71,909 |
|
|
Income (loss) from
operations |
3,736 |
|
|
|
(23,648 |
) |
|
|
(29,420 |
) |
|
Interest expense |
(19,040 |
) |
|
|
(10,192 |
) |
|
|
(8,577 |
) |
|
Bargain purchase gain |
— |
|
|
|
— |
|
|
|
27,336 |
|
|
Other income (expense), net |
4 |
|
|
|
(14 |
) |
|
|
(26 |
) |
|
Loss before income taxes |
(15,300 |
) |
|
|
(33,854 |
) |
|
|
(10,687 |
) |
|
Income tax (expense) benefit |
(5 |
) |
|
|
(13 |
) |
|
|
15,972 |
|
|
Net (loss) income |
(15,305 |
) |
|
|
(33,867 |
) |
|
|
5,285 |
|
|
Beneficial conversion feature of
convertible preferred stock |
— |
|
|
|
(12,500 |
) |
|
|
— |
|
|
Net (loss) income attributable to
common stockholders |
$ |
(15,305 |
) |
|
|
$ |
(46,367 |
) |
|
|
$ |
5,285 |
|
|
Basic: |
|
|
|
|
|
Weighted average common stock
shares outstanding |
83,213,704 |
|
|
|
63,165,063 |
|
|
|
55,355,802 |
|
|
Basic (loss) earnings per
share |
$ |
(0.18 |
) |
|
|
$ |
(0.73 |
) |
|
|
$ |
0.10 |
|
|
Diluted: |
|
|
|
|
|
Diluted weighted average common
stock shares outstanding |
83,213,704 |
|
|
|
63,165,063 |
|
|
|
56,402,479 |
|
|
Diluted (loss) earnings per
share |
$ |
(0.18 |
) |
|
|
$ |
(0.73 |
) |
|
|
$ |
0.09 |
|
|
BIODELIVERY SCIENCES INTERNATIONAL, INC.
AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH
FLOWS(U.S. DOLLARS, IN THOUSANDS)
|
Year Ended December 31, |
|
2019 |
|
2018 |
|
2017 |
Operating activities: |
|
|
|
|
|
Net (loss) income |
$ |
(15,305 |
) |
|
|
$ |
(33,867 |
) |
|
|
$ |
5,285 |
|
|
Adjustments to reconcile net
(loss) income to net cash flows provided by (used in) operating
activities |
|
|
|
|
|
Depreciation |
1,846 |
|
|
|
740 |
|
|
|
693 |
|
|
Accretion of debt discount and
loan costs |
11,508 |
|
|
|
4,138 |
|
|
|
2,392 |
|
|
Amortization of intangible
assets |
6,981 |
|
|
|
5,157 |
|
|
|
5,425 |
|
|
Provision for (recovery from)
inventory obsolescence |
197 |
|
|
|
(56 |
) |
|
|
243 |
|
|
Impairment loss on equipment |
— |
|
|
|
78 |
|
|
|
— |
|
|
Stock-based compensation
expense |
5,416 |
|
|
|
5,941 |
|
|
|
14,801 |
|
|
Deferred income taxes |
— |
|
|
|
40 |
|
|
|
(15,972 |
) |
|
Bargain purchase gain |
— |
|
|
|
— |
|
|
|
(27,336 |
) |
|
Changes in assets and
liabilities, net of effect of acquisition: |
|
|
|
|
|
Accounts receivable |
(25,163 |
) |
|
|
(4,640 |
) |
|
|
(5,884 |
) |
|
Inventories |
(6,102 |
) |
|
|
741 |
|
|
|
2,448 |
|
|
Prepaid expenses and other
assets |
(581 |
) |
|
|
422 |
|
|
|
526 |
|
|
Accounts payable and accrued
expenses |
32,275 |
|
|
|
(2,807 |
) |
|
|
6,644 |
|
|
Deferred revenue |
— |
|
|
|
— |
|
|
|
(21,716 |
) |
|
Net cash flows provided by (used
in) operating activities |
11,072 |
|
|
|
(24,113 |
) |
|
|
(32,451 |
) |
|
Investing activities: |
|
|
|
|
|
Product acquisitions |
(30,685 |
) |
|
|
(1,951 |
) |
|
|
(5,853 |
) |
|
Acquisitions of equipment |
(79 |
) |
|
|
(112 |
) |
|
|
(11 |
) |
|
Net cash flows used in investing
activities |
(30,764 |
) |
|
|
(2,063 |
) |
|
|
(5,864 |
) |
|
Financing activities: |
|
|
|
|
|
Proceeds from exercise of stock
options |
2,321 |
|
|
|
670 |
|
|
|
439 |
|
|
Proceeds from issuance of common
stock, less underwriters discount |
48,000 |
|
|
|
— |
|
|
|
— |
|
|
Proceeds from issuance of Series
B preferred stock |
— |
|
|
|
50,000 |
|
|
|
— |
|
|
Payment on note payable |
(67,346 |
) |
|
|
— |
|
|
|
(30,000 |
) |
|
Proceeds from notes payable |
59,987 |
|
|
|
— |
|
|
|
60,000 |
|
|
Equity finance costs |
(410 |
) |
|
|
(1,417 |
) |
|
|
— |
Payment of deferred financing
fees |
— |
|
|
|
(450 |
) |
|
|
(2,948 |
) |
|
Loss on refinancing of former
debt |
(2,794 |
) |
|
|
— |
|
|
|
— |
|
|
Net cash flows provided by
financing activities |
39,758 |
|
|
|
48,803 |
|
|
|
27,491 |
|
|
Net change in cash and cash
equivalents |
20,066 |
|
|
|
22,627 |
|
|
|
(10,824 |
) |
|
Cash and cash equivalents at
beginning of year |
43,822 |
|
|
|
21,195 |
|
|
|
32,019 |
|
|
Cash and cash
equivalents at end of year |
$ |
63,888 |
|
|
|
$ |
43,822 |
|
|
|
$ |
21,195 |
|
|
Reconciliations of non-GAAP metrics to most directly
comparable U.S. GAAP financial measures:
The following tables reconcile net income/(loss)earnings and
computations (in thousands) under GAAP to a Non-GAAP basis.
|
Year Ended December 31, |
Reconciliation of GAAP
net income/(loss) to EBITDA (non-GAAP) |
2019 |
2018 |
2017 |
GAAP net income/(loss) |
$ |
(15,305 |
) |
|
$ |
(33,867 |
) |
|
$ |
5,285 |
|
|
Add back: |
|
|
|
Provision for income
taxes |
5 |
|
|
14 |
|
|
(15,972 |
) |
|
Net interest expense |
19,036 |
|
|
10,206 |
|
|
(18,733 |
) |
|
Depreciation and
amortization |
8,748 |
|
|
6,188 |
|
|
6,119 |
|
|
EBITDA |
$ |
12,484 |
|
|
$ |
(17,459 |
) |
|
$ |
(23,301 |
) |
|
Reconciliation of GAAP
net income/(loss) to Non-GAAP net income/(loss) |
|
|
|
GAAP net income/(loss) |
(15,305 |
) |
|
(33,867 |
) |
|
5,285 |
|
|
Non-GAAP adjustments: |
|
|
|
Stock-based compensation
expense |
5,416 |
|
|
5,941 |
|
|
14,800 |
|
|
Amortization of intangible
assets |
6,981 |
|
|
5,157 |
|
|
5,425 |
|
|
Amortization of warrant
discount |
448 |
|
|
1,076 |
|
|
832 |
|
|
Non-recurring financial impact
of debt refinance |
11,866 |
|
|
— |
|
|
— |
|
|
Non-recurring financial impact
of BUNAVAIL discontinuation |
3,750 |
|
|
0 |
|
|
0 |
|
|
Non-recurring financial impact
of bargain purchase gain |
0 |
|
|
0 |
|
|
(27,336 |
) |
|
Non-GAAP net
income/(loss) |
$ |
13,156 |
|
|
$ |
(21,693 |
) |
|
$ |
(994 |
) |
|
|
Quarter Ended December 31, |
Reconciliation of GAAP
net income/(loss) to EBITDA (non-GAAP) |
2019 |
2018 |
GAAP net income/(loss) |
$ |
(696 |
) |
|
$ |
(7,008 |
) |
|
Add back: |
|
|
Provision for income
taxes |
1 |
|
|
(40 |
) |
|
Net interest expense |
1,308 |
|
|
2,600 |
|
|
Depreciation and
amortization |
3,491 |
|
|
1,470 |
|
|
EBITDA |
$ |
4,104 |
|
|
$ |
(2,978 |
) |
|
Reconciliation of GAAP
net income/(loss) to Non-GAAP net income/(loss) |
|
|
GAAP net income/(loss) |
(696 |
) |
|
(7,008 |
) |
|
Non-GAAP adjustments: |
|
|
Stock-based compensation
expense |
1,438 |
|
|
1,045 |
|
|
Amortization of intangible
assets |
1,899 |
|
|
1,289 |
|
|
Amortization of warrant
discount |
— |
|
|
269 |
|
|
Non-recurring financial impact
of BUNAVAIL discontinuation |
3,750 |
|
|
— |
|
|
Non-GAAP net
income/(loss) |
$ |
6,391 |
|
|
$ |
(21,693 |
) |
|
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