RALEIGH, N.C., May 15, 2017 /PRNewswire/ -- BioDelivery Sciences
International, Inc. (BDSI) today reported financial results for the
first quarter ended March 31, 2017
and provided a corporate update.
"We are very pleased with the financial results of the first
quarter, particularly what we were able to accomplish with
BELBUCA® in our hands," said Dr. Mark A. Sirgo, President and Chief Executive
Officer of BDSI. "We completed a swift and effective
transition of BELBUCA following the early January close of the
transaction with Endo Pharmaceuticals (Endo), and by the end of the
quarter, we were generating sufficient product revenue to offset
the expense of our commercial business unit. In fact, we
recorded the highest net sales revenue for BELBUCA since the
product was launched over a year ago, and albeit early in the
relaunch, it appears our focused selling approach and commercial
strategy are working. These efforts led to first quarter
sales of $4.6 million in comparison
to what would have been approximately $640
thousand in royalties had we not reacquired the
product. Importantly, the impact of the BELBUCA license
termination and reacquisition has resulted in $43.3 million in value that is added to BDSI's
balance sheet. This gain in value arises out of the very favorable
terms on which BDSI reacquired BELBUCA. In addition, we are
vigorously pursuing potential licensing agreements and remain
focused on securing up to two ex-U.S. partnerships for BELBUCA in
the coming months."
"As for BUNAVAIL®, we will continue to focus our
efforts on our current prescribers while working to secure new
managed contracts where BUNAVAIL is in a favorable position.
BUNAVAIL generated $3.2 million in
revenue for the quarter."
"Finally, to support our currently planned activities into the
second half of 2018, we recently completed a debt financing for a
total of up to $75 million,
$45 million of which was funded in
February 2017. We believe this has allowed us to take the
appropriate steps, in a non-dilutive fashion, to strengthen our
balance sheet, which allows us to now put our full attention on
growing the business."
First Quarter 2017 Financial Highlights
Net revenue for the first quarter ended March 31, 2017, was approximately $29.5 million. Total net sales of BELBUCA
(buprenorphine) buccal film (CIII) and BUNAVAIL (buprenorphine and
naloxone) buccal film (CIII) in the first quarter were $4.6 million and $3.2
million, respectively. This compares to BUNAVAIL total
net revenue of approximately $2.1
million in the first quarter of 2016. The $20 million of contract revenues recorded in the
three months ended March 31, 2017, is
related to the release of deferred revenue for BELBUCA upon the
reacquisition from Endo. This deferred revenue was part
of the $50 million NDA approval
milestone payment received by BDSI from Endo. The $20 million had been deferred because it was tied
to the entry of any generic competition between 2020 and 2027.
Total operating expenses for the first quarter ended
March 31, 2017, were $15.9 million, compared to $18.4 million in the first quarter of 2016, with
the reduction in operating expenses being attributable to reduced
research and development spending.
Net income for the first quarter ended March 31, 2017 was $48.3
million, or $0.89 per basic
and $0.87 per diluted share, compared
to a net loss of $18.7 million, or
($0.36) per basic and diluted share,
in the same period of 2016. The increase in net income was
attributable principally to the impact of the valuation of the
licensing and distribution agreement for BELBUCA and recognition of
deferred revenue associated with the license termination and
reacquisition of BELBUCA.
BDSI had cash and cash equivalents of approximately $35.2 million at March 31,
2017, including net proceeds of $13.7
million from the initial funding under the CRG facility
in February 2017. This compares to cash and cash
equivalents of approximately $32.0
million at December 31, 2016.
BDSI also began recognizing revenue using the sell-in method,
which records sales based on product sold to wholesalers versus
sell-through method previously. As such, we recognized
$1.7 million of the $3.2 million of BUNAVAIL sales for product
shipped to wholesalers prior to January
1, 2017.
Recent Company Milestones
Commercial
- Closed on an agreement with Endo Pharmaceuticals, terminating
Endo's licensing of rights for BELBUCA and returning worldwide
rights to the product back to BDSI.
- Generated total product revenue of $9.5
million in the first quarter of 2017
-
- Achieved the highest net sales level for BELBUCA since the
product was launched.
- Achieved profitability in commercial business unit in the month
of March, although not full enterprise profitability.
Regulatory
- Received approval from the U.S. Food and Drug Administration's
(FDA) for a Supplemental New Drug Application (sNDA) expanding the
indication for BUNAVAIL to include induction of buprenorphine
treatment for opioid dependence. Induction is the first step to
assist a patient in discontinuing or markedly reducing their use of
opioids.
- Received FDA acceptance of the Investigational New Drug (IND)
for Sustained Release Buprenorphine Injection, allowing initiation
of the clinical development program.
Intellectual Property
- Strengthened the intellectual property surrounding BELBUCA,
BUNAVAIL and ONSOLIS®, with the granting of two new patents listed
in FDA's Orange Book
Corporate
- Secured a $75 million senior
credit facility with affiliates of CRG LP, a healthcare-focused
investment firm, to retire existing credit facility and provide
additional working capital into the second half of 2018.
Key Anticipated 2017 Milestones
- Opportunity to execute up to two commercial transactions for
ex-U.S. rights to BELBUCA in the coming months.
- Anticipated approval of BELBUCA in Canada in June
2017.
- Initiation of, and initial results from, an ascending, single
dose pharmacokinetic study of sustained release buprenorphine
injection. Results from the first dosing cohort expected to be
available in the fourth quarter.
- Planned regulatory submission later this year to qualify the
new manufacturer for ONSOLIS (product licensed to Collegium
Pharmaceutical) and, if approved, allows the product to return to
market early in the first half of 2018.
Conference Call & Webcast
Monday, May 15
@ 4:30 PM Eastern Time
|
Domestic:
|
888-437-9364
|
International:
|
719-325-2133
|
Passcode:
|
7698100
|
Webcast:
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http://public.viavid.com/index.php?id=124144
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Replays available
through May 29th:
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Domestic:
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844-512-2921
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International:
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412-317-6671
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Conference
ID:
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7698100
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About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a
specialty pharmaceutical company with a focus in the areas of pain
management and addiction medicine. BDSI is utilizing its
novel and proprietary BioErodible MucoAdhesive (BEMA®)
technology and other drug delivery technologies to develop and
commercialize, either on its own or in partnership with third
parties, new applications of proven therapies aimed at addressing
important unmet medical needs.
BDSI's development strategy focuses on the utilization of the
FDA's 505(b)(2) approval process. This regulatory pathway creates
the potential for more timely and efficient approval of new
formulations of previously approved therapeutics.
BDSI's area of focus is the development and commercialization of
products in the areas of pain management and addiction. These are
areas where BDSI believes its drug delivery technologies and
products can best be applied to address critical unmet medical
needs. BDSI's marketed products and those in development
address serious and debilitating conditions such as breakthrough
cancer pain, chronic pain, painful diabetic neuropathy and opioid
dependence. BDSI's headquarters is in Raleigh, North
Carolina.
For more information,
please visit or follow us:
|
Internet:
|
www.bdsi.com
|
Facebook:
|
Facebook.com/BioDeliverySI
|
Twitter:
|
@BioDeliverySI
|
BUNAVAIL® (buprenorphine and naloxone) buccal film
(CIII) and BELBUCA® (buprenorphine) buccal film (CIII)
are marketed in the U.S. by BioDelivery Sciences.
ONSOLIS® (fentanyl buccal soluble film) (CII) is
licensed in the U.S. to Collegium Pharmaceutical pursuant to the
U.S. licensing and development agreement between BDSI and
Collegium. For full prescribing information and important safety
information on BDSI products, including BOXED WARNINGS for ONSOLIS,
please visit www.bdsi.com where the Company promptly
posts press releases, SEC filings and other important information
or contact the Company at (800) 469-0261. For full
prescribing and safety information on BELBUCA, please visit
www.belbuca.com and for full prescribing and safety
information on BUNAVAIL, please visit www.bunavail.com.
Cautionary Note on Forward-Looking Statements
This press release and any statements of employees,
representatives and partners of BioDelivery Sciences International,
Inc. (the "Company") related thereto (including, without
limitation, at the presentation described herein) contain, or may
contain, among other things, certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such forward-looking statements involve significant
risks and uncertainties. Such statements may include, without
limitation, statements with respect to the Company's plans,
objectives, projections, expectations and intentions and other
statements identified by words such as "projects," "may," "will,"
"could," "would," "should," "believes," "expects," "anticipates,"
"estimates," "intends," "plans," "potential" or similar
expressions. These statements are based upon the current
beliefs and expectations of the Company's management and are
subject to significant risks and uncertainties, including those
detailed in the Company's filings with the Securities and Exchange
Commission. Actual results (including, without limitation,
the results of commercialization efforts for the Company's approved
products and the clinical trials for, and regulatory review of, the
Company's products in development) may differ significantly from
those set forth in the forward-looking statements. These
forward-looking statements involve certain risks and uncertainties
that are subject to change based on various factors (many of which
are beyond the Company's control). The Company undertakes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future presentations or
otherwise, except as required by applicable law.
BDSI®, BEMA®, ONSOLIS®,
BUNAVAIL® and BELBUCA® are registered
trademarks of BioDelivery Sciences International, Inc. The
BioDelivery Sciences, BUNAVAIL and BELBUCA logos are trademarks
owned by BioDelivery Sciences International, Inc. All other
trademarks and tradenames are owned by their respective owners.
© 2017 BioDelivery Sciences International, Inc. All rights
reserved.
BIODELIVERY
SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(U.S. dollars, in
thousands, except share and per share amounts)
|
(Unaudited)
|
|
March
31,
|
December
31,
|
|
2017
|
2016
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
35,219
|
$
32,019
|
Accounts
receivable
|
7,102
|
3,569
|
Inventory
|
8,145
|
3,368
|
Prepaid expenses and other
current assets
|
3,942
|
4,136
|
Total current
assets
|
54,408
|
43,092
|
|
|
|
Property and
equipment, net
|
4,549
|
4,230
|
Goodwill
|
2,715
|
2,715
|
BELBUCA license and
distribution rights intangible
|
45,000
|
-
|
Other intangible
assets, net
|
918
|
2,285
|
Total assets
|
$
107,590
|
$
52,322
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
Current
liabilities:
|
|
|
Accounts payable and accrued
liabilities
|
$
30,521
|
$
18,174
|
Deferred revenue,
current
|
-
|
1,716
|
Total current
liabilities
|
30,521
|
19,890
|
|
|
|
Notes payable,
current maturities, net
|
34,800
|
29,272
|
Deferred revenue,
long term
|
-
|
20,000
|
Other long-term
liabilities
|
4,050
|
825
|
Total liabilities
|
69,371
|
69,987
|
|
|
|
Commitments and
contingencies (Notes 11 and 14)
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
Preferred Stock,
$.001 par value; 5,000,000 shares authorized; 2,093,155 and
2,093,155
shares of Series A
Non-Voting Convertible Preferred Stock outstanding at both March
31,
2017 and December 31,
2016 and 2015, respectively.
|
2
|
2
|
Common Stock, $.001
par value; 75,000,000 shares authorized; 55,341,463 and
54,133,511
shares issued;
55,325,972 and 54,118,020 shares outstanding at March 31, 2017
and
December 31, 2016,
respectively.
|
55
|
54
|
Additional paid-in
capital
|
300,225
|
292,667
|
Treasury stock, at
cost, 15,491 shares
|
(47)
|
(47)
|
Accumulated
deficit
|
(262,016)
|
(310,341)
|
Total stockholders' equity
(deficit)
|
38,219
|
(17,665)
|
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
$
107,590
|
$
52,322
|
BIODELIVERY
SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(U.S. DOLLARS, IN
THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
|
(Unaudited)
|
|
|
|
|
Three Months Ended
March 31,
|
|
2017
|
2016
|
Revenues:
|
|
|
Product sales
|
$
7,795
|
$
2,102
|
Product royalty
revenues
|
1,661
|
934
|
Research and development
reimbursements
|
22
|
4
|
Contract revenue
|
20,000
|
-
|
Total Revenues:
|
29,478
|
3,040
|
|
|
|
Cost of
sales
|
5,645
|
2,550
|
|
|
|
Expenses:
|
|
|
Research and
development:
|
2,671
|
5,377
|
Sales, general and
administrative
|
13,259
|
13,055
|
Total Expenses:
|
15,930
|
18,432
|
|
|
|
Income (loss) from
operations
|
7,903
|
(17,942)
|
Interest expense,
net
|
(2,886)
|
(778)
|
Other expense,
net
|
-
|
(13)
|
Bargain purchase
gain
|
27,336
|
-
|
Income
(loss)
|
$
32,353
|
$
(18,733)
|
|
|
|
Income tax
benefit
|
15,972
|
$
-
|
Net income (loss)
attributable to common stockholders
|
$
48,325
|
$
(18,733)
|
|
|
|
Basic:
|
|
|
Basic income (loss)
per share
|
$
0.59
|
$
(0.36)
|
Weighted average
common stock shares outstanding
|
54,519,574
|
52,230,648
|
|
|
|
Diluted:
|
|
|
Diluted income (loss)
per share
|
$
0.58
|
$
(0.36)
|
Weighted average
common stock shares outstanding
|
55,431,628
|
52,230,648
|
|
BIODELIVERY
SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
(U.S. DOLLARS, IN
THOUSANDS)
|
|
(Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2017
|
2016
|
Operating
activities:
|
|
|
|
Net income
(loss)
|
$
48,325
|
$
(18,733)
|
|
|
Depreciation
|
111
|
86
|
|
|
Accretion of debt
discount and loan costs
|
1,040
|
99
|
|
|
Amortization of
Intangible Assets
|
1,369
|
243
|
|
|
Stock-based
compensation expense
|
3,070
|
4,111
|
|
|
Deferred income
taxes
|
(15,972)
|
-
|
|
|
Bargain purchase
gain
|
(27,336)
|
-
|
|
Changes in assets and
liabilities:
|
|
|
|
|
Accounts
receivable
|
(3,531)
|
356
|
|
|
Inventories, net of
effect of acquisition
|
633
|
(2,263)
|
|
|
Prepaid expenses and
other assets
|
194
|
118
|
|
|
Accounts payable and
accrued expenses, net of effect of acquisition
|
4,811
|
(438)
|
|
|
Deferred
Revenue
|
(21,716)
|
(235)
|
|
Net cash flows from
operating activities
|
(9,002)
|
(16,656)
|
|
|
|
|
|
Investing
activities:
|
|
|
|
|
Purchase of
equipment
|
-
|
(236)
|
|
Net cash flows from
investing activities
|
-
|
(236)
|
|
|
|
|
|
Financing
activities:
|
|
|
|
|
Proceeds from notes
payable
|
45,000
|
-
|
|
|
Payment of notes
payable
|
(30,000)
|
-
|
|
|
Payment of deferred
financing fees
|
(2,798)
|
-
|
|
|
Equity financing
costs
|
-
|
40
|
|
|
Proceeds from
exercise of stock options
|
-
|
225
|
|
|
Proceeds form
issuance of common stock
|
-
|
2,460
|
|
Net cash flows from
financing activities
|
12,202
|
2,725
|
Net change in cash
and cash equivalents
|
3,200
|
(14,167)
|
Cash and cash
equivalents at beginning of year
|
32,019
|
83,560
|
Cash and cash
equivalents at end of year
|
$
35,219
|
$
69,392
|
Cash paid for
interest
|
$
946
|
$
679
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/biodelivery-sciences-reports-first-quarter-2017-financial-results-and-provides-corporate-update-300457765.html
SOURCE BioDelivery Sciences International, Inc.