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 first quarter ended March
31, 2020, as well as the following operational and performance
highlights.
Key Business Highlights
- Total Company net revenue for the first quarter increased by
94% versus the prior year period to a record level of $38.3
million. This growth was driven by BELBUCA sales of $33.5
million, an increase of 79% versus the prior year period, and
Symproic® sales of $4.2 million.
- Total BELBUCA prescriptions reached an all-time high of 99,400
during the first quarter, representing year-over-year prescription
volume growth of more than 52%.
- Total Symproic prescriptions were more than 16,100 in the first
quarter, representing growth of 19% versus the prior year
period.
- Achieved record number of unique prescribers during the quarter
for both BELBUCA and Symproic.
- Continued to expand BELBUCA Medicare patient access with the
addition of more than two million covered lives, the vast majority
of which have preferred access to BELBUCA, through a national
PBM.
- Expanded BELBUCA commercial coverage within two important
regional plans representing nearly 900,000 lives that can receive
BELBUCA without being required to first fail two CII long-acting
opioids.
- Strong financial position driven by performance and positive
cash flow of $6.7 million in the quarter.
“I am very pleased by the success and momentum we achieved
during the first quarter,” stated Herm Cukier, CEO of BDSI. “Both
BELBUCA and Symproic prescriptions were experiencing considerable
growth before the start of the COVID-19 pandemic, helping deliver
strong first quarter results. I am also very proud of how the
organization rapidly transitioned our efforts to virtual
connectivity with our prescribers, ensured continuity of supply,
and continued to provide valuable service to patients. While these
are unprecedented and uncertain times, I remain very confident in
the clinical value of our products and the long-term prospects for
the company.”
First Quarter 2020 Financial Results
Total Company Net Revenue for the first quarter
of 2020 was $38.3 million, an increase of 94% compared to $19.8
million in the first quarter of 2019, and an increase of 21%
compared to $31.6 million in the fourth quarter of 2019.
BELBUCA Net Sales for the first quarter of 2020
were $33.5 million, an increase of 79% compared to $18.7 million in
the first quarter of 2019, and an increase of 18% compared to $28.3
million in the fourth quarter of 2019.
Symproic Net Sales for the first quarter were
$4.2 million, an increase of 54% compared to $2.7 million in the
fourth quarter of 2019.
BUNAVAIL Net Sales for the first quarter were
$0.1 million compared to $1.1 million in the first quarter of 2019.
In March of this year, the Company announced the planned
discontinuation of marketing of BUNAVAIL in 2020.
Total Operating Expenses for the first quarter
of 2020 were $26.7 million, compared to $23.8 million in the fourth
quarter of 2019 and $17.0 million in the first quarter of 2019.
GAAP Net Income for the first quarter of
2020 was $5.0 million, or $0.05 per share, compared to GAAP
net loss of $0.7 million, or ($0.01) per share, for the fourth
quarter of 2019 and GAAP net loss of $3.8 million, or ($0.05) per
share, in the first quarter of 2019.
EBITDA in the first quarter of 2020 was $7.8
million, or 20% of net sales, compared to $4.1 million in the
fourth quarter of 2019 and $0.1 million in the first quarter of
2019.
Non-GAAP Net Income for the quarter was $8.3
million and reflects GAAP net income excluding stock-based
compensation and non-cash amortization of intangible assets.
Cash Position: As of March 31, 2020, cash and
cash equivalents were approximately $70.6 million, compared to
$63.9 million in the fourth quarter of 2019, reflecting positive
cash flow of $6.7 million in the first quarter of 2020.
2020 Net Sales Guidance:
Given the uncertainty surrounding the COVID-19 pandemic, the
Company is withdrawing its 2020 BELBUCA and Total Company net sales
guidance, previously introduced in November 2019.
Conference Call & Webcast Details
BioDelivery Sciences will host a conference call and
webcast today, May 7, 2020, at 4:30 p.m. ET to
present first quarter 2020 results and to provide a business
update. Dial-in details are as follows:
|
Date: |
Thursday, May
7, 2020 |
| Time: |
4:30 PM Eastern Time |
| Domestic: |
800-289-0571 |
| International: |
720-543-0206 |
| Conference ID: |
6176462 |
| Webcast: |
http://public.viavid.com/index.php?id=139300 |
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
the impact of 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 SUBSIDIARIESCONDENSED
CONSOLIDATED BALANCE SHEETS(U.S. DOLLARS, IN
THOUSANDS, EXCEPT SHARE AND PER SHARE
AMOUNTS)(Unaudited)
| |
March 31, 2020 |
|
December 31, 2019 |
|
ASSETS |
|
|
|
| Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
70,613 |
|
|
$ |
63,888 |
|
|
Accounts receivable, net |
45,114 |
|
|
38,790 |
|
|
Inventory, net |
15,003 |
|
|
11,312 |
|
|
Prepaid expenses and other current assets |
2,600 |
|
|
3,769 |
|
|
Total current assets |
133,330 |
|
|
117,759 |
|
| Property and equipment, net |
1,995 |
|
|
2,075 |
|
| Goodwill |
2,715 |
|
|
2,715 |
|
| License and distribution rights,
net |
58,576 |
|
|
60,309 |
|
| Other intangible assets, net |
— |
|
|
47 |
|
|
Total assets |
$ |
196,616 |
|
|
$ |
182,905 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
| Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
$ |
60,931 |
|
|
$ |
53,993 |
|
|
Total current liabilities |
60,931 |
|
|
53,993 |
|
| Notes payable, net |
58,634 |
|
|
58,568 |
|
| Other long-term liabilities |
463 |
|
|
580 |
|
|
Total liabilities |
120,028 |
|
|
113,141 |
|
| Commitments and
contingencies |
|
|
|
| Stockholders’ equity: |
|
|
|
|
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 March 31, 2020 and December 31,
2019, respectively; Series B Non-Voting Convertible Preferred
Stock, $0.001 par value, 443 and 618 shares outstanding at
March 31, 2020 and December 31, 2019, respectively. |
— |
|
|
2 |
|
|
Common Stock, $0.001 par value; 175,000,000 shares authorized at
March 31, 2020 and December 31, 2019, respectively;
99,821,408 and 96,189,074 shares issued; 99,805,917 and 96,173,583
shares outstanding at March 31, 2020 and December 31,
2019, respectively. |
99 |
|
|
96 |
|
|
Additional paid-in capital |
438,163 |
|
|
436,306 |
|
|
Treasury stock, at cost,15,491 shares, as of March 31, 2020
and December 31, 2019. |
(47 |
) |
|
(47 |
) |
|
Accumulated deficit |
(361,627 |
) |
|
(366,593 |
) |
|
Total stockholders’ equity |
76,588 |
|
|
69,764 |
|
| Total liabilities and
stockholders’ equity |
$ |
196,616 |
|
|
$ |
182,905 |
|
| |
|
|
|
|
|
|
|
BIODELIVERY SCIENCES INTERNATIONAL, INC.
AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS(U.S. DOLLARS, IN THOUSANDS, EXCEPT
SHARE AND PER SHARE
AMOUNTS)(Unaudited)
| |
Three months ended |
| |
March 31, 2020 |
|
Dec. 31, 2019 |
March 31, 2019 |
| Revenues: |
|
|
|
|
|
Product sales |
$ |
37,715 |
|
|
$ |
30,450 |
|
$ |
19,759 |
|
|
Product royalty revenues |
563 |
|
|
|
1,187 |
|
2 |
|
|
Contract revenues |
— |
|
|
|
— |
|
8 |
|
|
Total Revenues: |
38,278 |
|
|
|
31,637 |
|
19,769 |
|
| Cost of sales |
5,560 |
|
|
|
7,264 |
|
4,052 |
|
| Expenses: |
|
|
|
|
|
Selling, general and administrative |
26,736 |
|
|
|
23,759 |
|
16,989 |
|
|
Total Expenses: |
26,736 |
|
|
|
23,759 |
|
16,989 |
|
| Income (loss) from
operations |
5,982 |
|
|
|
614 |
|
(1,272 |
) |
| Interest expense |
(1,293 |
) |
|
|
(1,308 |
) |
(2,561 |
) |
| Other expense, net |
(1 |
) |
|
|
(1 |
) |
— |
|
| Income (loss) before income
taxes |
$ |
4,688 |
|
|
$ |
(695 |
) |
$ |
(3,833 |
) |
| Income tax benefit |
278 |
|
|
|
(1 |
) |
— |
|
| Net income (loss) attributable to
common stockholders |
$ |
4,966 |
|
|
$ |
(696 |
) |
$ |
(3,833 |
) |
| Basic |
|
|
|
|
| Weighted average common stock
shares outstanding |
97,118,267 |
|
|
|
92,118,497 |
|
71,344,831 |
|
| Basic earnings (loss) per
share |
$ |
0.05 |
|
|
$ |
(0.01 |
) |
$ |
(0.05 |
) |
| Diluted |
|
|
|
|
| Weighted average common stock
shares outstanding |
106,965,762 |
|
|
|
92,118,497 |
|
71,344,831 |
|
| Diluted earnings (loss) per
share |
$ |
0.05 |
|
|
$ |
(0.01 |
) |
$ |
(0.05 |
) |
| |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
BIODELIVERY SCIENCES INTERNATIONAL, INC.
AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS(U.S. DOLLARS, IN
THOUSANDS)(Unaudited)
| |
Three months ended |
| |
March 31, 2020 |
|
Dec. 31, 2019 |
March 31, 2019 |
| Operating activities: |
|
|
|
|
|
Net income (loss) |
$ |
4,966 |
|
|
$ |
( 696 |
) |
$ |
(3,833 |
) |
|
Adjustments to reconcile net loss to net cash flows from operating
activities |
|
|
|
|
|
Depreciation |
21 |
|
|
|
1,592 |
|
85 |
|
|
Accretion of debt discount and loan costs |
65 |
|
|
|
67 |
|
634 |
|
|
Amortization of intangible assets |
1,781 |
|
|
|
1,896 |
|
1,289 |
|
|
Provision for inventory obsolescence |
405 |
|
|
|
140 |
|
149 |
|
|
Stock-based compensation expense |
1,520 |
|
|
|
1,438 |
|
1,141 |
|
|
Changes in assets and liabilities: |
|
|
|
|
|
Accounts receivable |
(6,324 |
) |
|
|
(5,368 |
) |
(2,381 |
) |
|
Inventories |
(4,096 |
) |
|
|
(685 |
) |
(2,002 |
) |
|
Prepaid expenses and other assets |
1,169 |
|
|
|
1,106 |
|
218 |
|
|
Accounts payable and accrued liabilities |
6,920 |
|
|
|
17,432 |
|
1,814 |
|
|
Taxes payable |
(40 |
) |
|
|
— |
|
|
Net cash flows provided by (used in) operating activities |
6,387 |
|
|
|
16,922 |
|
(2,886 |
) |
| Investing activities: |
|
|
|
|
|
Product Acquisitions |
— |
|
|
|
(10,011 |
) |
— |
|
|
Disposal of property and equipment |
— |
|
|
|
— |
|
(79 |
) |
|
Net cash flows used in investing activities |
— |
|
|
|
(10,011 |
) |
(79 |
) |
| Financing activities: |
|
|
|
|
|
Proceeds from exercise of stock options |
338 |
|
|
|
1,127 |
|
472 |
|
|
Debt issuance costs |
— |
|
|
|
(13 |
) |
— |
|
|
Net cash flows provided by financing activities |
338 |
|
|
|
1,114 |
|
472 |
|
| Net change in cash and cash
equivalents |
6,725 |
|
|
|
8,025 |
|
(2,493 |
) |
| Cash and cash equivalents at
beginning of period |
63,888 |
|
|
|
55,863 |
|
43,822 |
|
| Cash and cash
equivalents at end of period |
$ |
70,613 |
|
|
$ |
63,888 |
|
$ |
41,329 |
|
| |
|
|
|
|
|
|
|
|
|
|
BIODELIVERY SCIENCES INTERNATIONAL, INC.
AND SUBSIDIARIES RECONCILIATION OF NON-GAAP
METRICS (U.S. DOLLARS, IN
THOUSANDS) (Unaudited)
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 |
| Reconciliation of GAAP
net income/(loss) to EBITDA (non-GAAP) |
March 31, 2020 |
Dec. 31, 2019 |
March 31, 2019 |
|
GAAP net income/(loss) |
$ |
4,966 |
|
$ |
(696 |
) |
$ |
(3,833 |
) |
|
Add back: |
|
|
|
|
Provision for income taxes |
(278 |
) |
|
1 |
|
— |
|
|
Net interest expense |
1,294 |
|
|
1,308 |
|
2,561 |
|
|
Depreciation and amortization |
1,802 |
|
|
3,491 |
|
1,375 |
|
| EBITDA |
$ |
7,784 |
|
$ |
4,104 |
|
$ |
103 |
|
| Reconciliation of GAAP
net income/(loss) to Non-GAAP net income/(loss) |
|
|
|
|
GAAP net income/(loss) |
4,966 |
|
|
(696 |
) |
(3,833 |
) |
|
Non-GAAP adjustments: |
|
|
|
|
Stock-based compensation expense |
1,520 |
|
|
1,438 |
|
1,142 |
|
|
Amortization of intangible assets |
1,781 |
|
|
1,899 |
|
1,289 |
|
|
Amortization of warrant discount |
— |
|
|
— |
|
269 |
|
|
Non-recurring financial impact – BUNAVAIL discontinuation |
— |
|
|
3,750 |
|
— |
|
| Non-GAAP net
income/(loss) |
$ |
8,267 |
|
$ |
6,391 |
|
$ |
(1,133 |
) |
| |
|
|
|
|
|
|
|
|
|
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