BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today
financial results for the fourth quarter and full year ended
December 31, 2016. In a separate press release issued earlier
today, BioCryst announced positive results from an interim analysis
of its APeX-1 clinical trial of BCX7353 for the treatment of HAE
attacks.
Fourth Quarter Financial Results
For the three months ended December 31, 2016,
total revenues increased to $9.0 million from $4.6 million in
the fourth quarter of 2015. This increase, compared to the fourth
quarter of 2015, resulted from higher peramivir royalty revenue and
inventory sales to Seqirus, and was slightly offset by lower
collaborative revenue in the fourth quarter of 2016.
Research and Development (R&D) expenses of
$12.2 million decreased in the fourth quarter of 2016, as compared
to R&D expense of $19.0 million in the fourth quarter of
2015. The decrease was due primarily to lower spending on the
Company’s HAE portfolio of compounds associated with the
discontinuation of avoralstat development in 2016.
Selling, general and administrative (SG&A)
expenses of $2.6 million in the fourth quarter of 2016 decreased
slightly from the $2.7 million in the fourth quarter of
2015.
Interest expense was $2.1 million for the
fourth quarter of 2016 and $1.3 million in the fourth quarter of
2015. Also, a $5.7 million mark-to-market gain on the
Company’s foreign currency hedge was recognized in the fourth
quarter of 2016, compared to a $229,000 mark-to-market gain in the
fourth quarter of 2015. These gains result from periodic
changes in the U.S. dollar/Japanese yen exchange rate and the
related mark-to-market valuation of our underlying hedge
arrangement.
The net loss for the fourth quarter of 2016 was
$4.5 million, or $0.06 per share, compared to a net loss of
$18.1 million, or $0.25 per share for the fourth quarter of
2015.
2016 Financial Results
For the year ended December 31, 2016, total
revenues decreased to $26.4 million from $48.3 million in
2015. The decrease in 2016 revenues, as compared to 2015, was
primarily due to the RAPIVAB out-licensing transaction to Seqirus,
which resulted in the recognition of $21.8 million of collaborative
revenue in 2015 and a $4.0 million decrease in 2016 RAPIVAB product
sales, as well as a reduction in collaboration revenue associated
with lower galidesivir development activity in 2016. All of these
decreases were slightly offset by a $7.3 million increase in 2016
peramivir royalty revenue derived from BioCryst’s commercial
partners. A component of the peramivir royalty revenue was $5.7
million of Japanese government stockpiling revenue that is
available for general corporate use. Although these orders
provided a significant cash infusion, stockpiling royalty revenues
may not recur on an annual basis as they are subject to the
Japanese government’s appropriation and stockpiling process, which
is difficult to predict.
R&D expenses decreased to $61.0 million
for 2016 from $72.8 million for 2015. This decrease was
primarily due to lower spending on the Company’s HAE portfolio of
compounds associated with the discontinuation of avoralstat
development in 2016.
SG&A expenses decreased to
$11.3 million in 2016 from $13.0 million in 2015, due
primarily to lower unrestricted grants awarded to HAE patient
advocacy groups, as well as a general reduction of administrative
expenses.
Interest expense was $6.5 million in 2016
and $5.2 million in 2015. In addition, a $1.7 million
mark-to-market loss on the Company’s foreign currency hedge was
recognized in 2016, compared to a $564,000 million mark-to-market
loss in 2015. These gains result from periodic changes in the
U.S. dollar/Japanese yen exchange rate and the related
mark-to-market valuation of our underlying hedge arrangement.
During 2016 and 2015, the Company also realized currency hedge
gains of $811,000 in 2016 and $1.7 million in 2015 from the
exercise of a U.S. Dollar/Japanese yen currency option.
The Company’s 2016 net loss increased to
$55.1 million, or $0.75 per share, compared to a net loss of
$43.0 million, or $0.59 per share for 2015.
Cash, cash equivalents and investments totaled
$65.1 million at December 31, 2016 and represented a $35.8 million
decrease from $100.9 million at December 31, 2015. Net operating
cash use for 2016 was $61.9 million. In September 2016, the Company
closed a $23 million senior credit facility that allowed it to
extend its forecasted cash runway into 2018.
Clinical Development Update
- On February 27th, the Company reported statistically
significant and clinically meaningful reductions in attack
frequency from an interim analysis of its ongoing APeX-1 clinical
trial in patients with HAE.
- On January 30th, the Company announced that the European
Medicines Agency (EMA) accepted the Company’s filing of its
peramivir Marketing Authorization Application (MAA) for treatment
of symptoms typical of influenza in adults 18 years and
older. The acceptance of the MAA begins the review process by
the EMA under the centralized licensing procedure for all 28 member
states of the European Union, Norway and Iceland.
- On January 8th, the Company announced that Health Canada
approved RAPIVAB® (peramivir injection), for
intravenous (I.V.) treatment of acute, uncomplicated influenza.
Peramivir is being commercialized by Seqirus on a worldwide basis,
excluding Japan, Taiwan, Korea and Israel.
- On October 26, 2016, the Company announced positive results
from a study of galidesivir (formerly BCX4430) administered to
Rhesus monkeys infected with the Zika virus at a late-breaker oral
presentation at IDWeek 2016 in New Orleans.
Financial Outlook for
2017
Based upon development plans and our awarded
government contracts, BioCryst expects its 2017 net operating cash
use to be in the range of $30 to $50 million, and its 2017
operating expenses to be in the range of $53 to $73 million.
Our operating expense range excludes equity-based compensation
expense due to the difficulty in reliably projecting this expense,
as it is impacted by the volatility and price of the Company’s
stock, as well as by vesting of the Company’s outstanding
performance-based stock options.
Conference Call and Webcast
BioCryst's leadership team will host a
conference call and webcast today, February 27, 2017 at 9:00 a.m.
Eastern Time, to discuss its APeX-1 interim analysis and to respond
to questions on its full year 2016 financial results. To
participate in the conference call, please dial 1-877-303-8027
(United States) or 1-760-536-5165 (International). No
passcode is needed for the call. The webcast can be accessed
by logging onto www.BioCryst.com. Please connect to the
website at least 15 minutes prior to the start of the conference
call to ensure adequate time for any software download that may be
necessary.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and
develops novel small molecule drugs that block key enzymes involved
in rare diseases. BioCryst currently has several ongoing
development programs: BCX7353 and second generation oral inhibitors
of plasma kallikrein for hereditary angioedema, and galidesivir, a
broad spectrum viral RNA polymerase inhibitor that is a potential
treatment for filoviruses. Peramivir, a viral neuraminidase
inhibitor, is approved for the treatment of influenza, in the U.S.,
Canada, Japan, Taiwan and Korea. Post-marketing commitment
development activities are ongoing, as well as other activities to
support additional peramivir regulatory approvals. For more
information, please visit the Company's website at
www.BioCryst.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements regarding future results,
performance or achievements. These statements involve known and
unknown risks, uncertainties and other factors which may cause
BioCryst’s actual results, performance or achievements to be
materially different from any future results, performances or
achievements expressed or implied by the forward-looking
statements. These statements reflect our current views with respect
to future events and are based on assumptions and are subject to
risks and uncertainties. Given these uncertainties, you should not
place undue reliance on these forward-looking statements. Some of
the factors that could affect the forward-looking statements
contained herein include: developing any HAE drug candidate may
take longer or may be more expensive than planned; ongoing and
future preclinical and clinical development of HAE second
generation drug candidates (including APeX-1) may not have positive
results; that BioCryst may not be able to enroll the required
number of subjects in planned clinical trials of product
candidates; that the Company may not advance human clinical trials
with product candidates as expected; that the FDA may require
additional studies beyond the studies planned for product
candidates, or may not provide regulatory clearances which may
result in delay of planned clinical trials, or may impose a
clinical hold with respect to such product candidate, or withhold
market approval for product candidates; that BioCryst may not
receive additional government funding to further support the
development of galidesivir; that galidesivir development may not be
successful; that BARDA and/or NIAID may further condition, reduce
or eliminate future funding; that revenue from peramivir is
unpredictable and commercialization of peramivir may never result
in significant revenue for the Company; that the Company may not be
able to continue development of ongoing and future development
programs; that such development programs may never result in future
products; that actual financial results may not be consistent with
expectations, including that 2017 operating expenses and cash usage
may not be within management’s expected ranges. Please refer
to the documents BioCryst files periodically with the Securities
and Exchange Commission, specifically BioCryst’s most recent Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current
Reports on Form 8-K, all of which identify important factors that
could cause the actual results to differ materially from those
contained in BioCryst’s projections and forward-looking
statements.
BCRXW
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BIOCRYST PHARMACEUTICALS, INC. |
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CONSOLIDATED FINANCIAL
SUMMARY |
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(in thousands, except per share) |
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Statements of Operations (Unaudited) |
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Three Months Ended |
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Twelve Months Ended |
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December 31, |
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December 31, |
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2016 |
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2015 |
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2016 |
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2015 |
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Revenues: |
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Product
sales, net |
$ |
|
2,269 |
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$ |
55 |
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$ |
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2,269 |
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$ |
6,291 |
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Royalty
revenue |
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3,662 |
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|
610 |
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9,682 |
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2,386 |
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Collaborative and other research and development |
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3,052 |
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3,937 |
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14,402 |
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39,580 |
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Total revenues |
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8,983 |
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4,602 |
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26,353 |
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48,257 |
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Expenses: |
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Cost of
goods sold |
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2,297 |
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7 |
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2,297 |
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1,368 |
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Research
and development |
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12,158 |
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19,047 |
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61,008 |
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72,758 |
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Selling,
general and administrative |
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|
2,561 |
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|
2,721 |
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|
11,253 |
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13,047 |
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Royalty |
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|
155 |
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|
21 |
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|
402 |
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|
528 |
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Total expenses |
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|
17,171 |
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|
21,796 |
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|
74,960 |
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|
87,701 |
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Loss from
operations |
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|
(8,188 |
) |
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(17,194 |
) |
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(48,607 |
) |
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(39,444 |
) |
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Interest and other
income |
|
|
98 |
|
|
|
168 |
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|
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|
793 |
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|
535 |
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Interest expense |
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(2,131 |
) |
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|
(1,338 |
) |
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|
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(6,487 |
) |
|
|
(5,200 |
) |
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Gain (Loss) on foreign
currency derivative |
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|
5,718 |
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|
|
229 |
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(843 |
) |
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1,090 |
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Net loss |
$ |
|
(4,503 |
) |
|
$ |
(18,135 |
) |
|
$ |
|
(55,144 |
) |
|
$ |
(43,019 |
) |
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Basic and diluted net
loss per common share |
$ |
|
(0.06 |
) |
|
$ |
(0.25 |
) |
|
$ |
|
(0.75 |
) |
|
$ |
(0.59 |
) |
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Weighted average shares
outstanding |
|
|
73,764 |
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|
73,345 |
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|
73,699 |
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|
72,901 |
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Balance Sheet
Data (in thousands) |
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December 31, 2016 |
|
December 31, 2015 |
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(Unaudited) |
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(Note 1) |
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Cash, cash equivalents
and investments |
|
$ |
63,576 |
|
|
|
|
$ |
99,246 |
|
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Restricted cash |
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|
1,546 |
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|
|
1,612 |
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Receivables from
collaborations |
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|
8,768 |
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|
6,243 |
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Total assets |
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89,847 |
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|
|
122,359 |
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Non-recourse notes
payable (Note 2) |
|
|
28,243 |
|
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|
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|
27,804 |
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Senior credit
facility |
|
|
22,777 |
|
|
|
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|
- |
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Accumulated
deficit |
|
|
(566,061 |
) |
|
|
|
|
(510,917 |
) |
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Stockholders’
equity |
|
|
1,578 |
|
|
|
|
|
47,724 |
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Note 1: Derived
from audited financial statements. |
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Note
2: Reflects retrospective application of ASU 2015-03,
Simplifying the Presentation of Debt Issuance Costs |
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CONTACT: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910
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