Full Press Release Details
BioCryst Reports Fourth Quarter and Full Year 2017 Financial Results
Updates Investors Regarding Proposed
Merger with Idera Pharmaceuticals, Inc.
Research Triangle Park, North Carolina
- February 27, 2018 - BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today financial results for the fourth
quarter and year ended December 31, 2017.
"Our team made significant progress
in 2017 and we are off to a strong start in 2018," said Jon P. Stonehouse, President & Chief Executive Officer. "We
are keenly focused on continuing that momentum by advancing our pipeline, adding additional programs and driving our BCX7353 oral
prophylactic program toward approval and launch. We are on track to report top-line results from the APeX-2 pivotal trial of BCX7353
and to initiate a Phase 1 clinical trial for our recently unveiled ALK2 inhibitor program for treating FOP in the first half of
Mr. Stonehouse continued, "In January,
we announced our proposed merger with Idera Pharmaceuticals, Inc. ("Idera") that we believe will build greater and
more sustainable value for the benefit of stockholders as well as patients with rare diseases beyond what we could achieve alone.
The BioCryst Board determined this combination was compelling from both a strategic and financial perspective following a careful
evaluation of a range of strategies to enhance long-term stockholder value. The transaction will create a leading rare disease
company with a robust pipeline including two promising Phase 3 programs and combines synergistic discovery engines that will not
only expand the number of rare diseases we can target but create meaningful opportunities for differentiation in the market through
joint small molecule and oligo treatments. Importantly, joining with Idera will also enable us to achieve cost synergies and increase
our financial strength and flexibility."
Fourth Quarter Financial Results
months ended December 31, 2017, total revenues were $3.9 million, compared to $9.0 million in the fourth quarter of 2016. The decrease
in revenue was primarily due to the recognition of $2.3 million of RAPIVAB product sales to commercial partners
in 2016 that did not recur in 2017 and approximately a $2.5 million decline in collaborative revenue in 2017, associated
with a decrease in development activity under U.S. Government development contracts.
Research and Development (R&D) expenses
for the fourth quarter of 2017 increased to $16.9 million from $12.2 million in the fourth quarter of 2016, primarily due
to additions in R&D personnel, as well as increased spending to advance the Company's hereditary angioedema (HAE) portfolio.
These increases were partially offset by a decrease in the Company's galidesivir development expenses in 2017.
General and administrative (G&A) expenses
for the fourth quarter of 2017 increased to $4.7 million, compared to $2.6 million in the fourth quarter of 2016. The increase
was primarily due to approximately $1.5 million of merger-related costs associated with the Company's previously announced
definitive merger agreement with Idera Pharmaceuticals, Inc. (Idera).
Interest expense was $2.2 million
in the fourth quarter of 2017, compared to $2.1 million in the fourth quarter of 2016. Also, a $71,000 mark-to-market gain
on the Company's foreign currency hedge was recognized in the fourth quarter of 2017, as compared to a $5.7 million mark-to-market
gain in the fourth quarter of 2016. These changes result from periodic changes in the U.S. dollar/Japanese yen exchange rate.
Net loss for the fourth quarter of 2017
was $19.5 million, or $0.20 per share, compared to a net loss of $4.5 million, or $0.06 per share, for the fourth quarter
Full Year 2017 Financial Results
For the year ended December 31, 2017, total
revenues decreased to $25.2 million from $26.4 million in 2016. The decrease in 2017 revenue was primarily due to lower collaborative
revenue under U.S. Government development contracts as well as lower revenue from product sales to corporate partners. These decreases
were largely offset by $7.0 million in milestone payments associated with U.S. pediatric and Canadian regulatory approvals of RAPIVAB.
R&D expenses for 2017 increased to
$67.0 million from $61.0 million in 2016, primarily due to increased spending on the Company's HAE program, partially
associated with the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical
trial, as well as an increase in R&D personnel. These increases were partially offset by a decrease in galidesivir development
expenses under U.S. Government development contracts.
G&A expenses for 2017 increased to
$13.9 million, compared to $11.3 million in 2016. The increase was due primarily to the achievement of a performance-based
stock option grant related to the successful completion of the APeX-1 clinical trial as well as merger-related costs associated
with the Company's definitive merger agreement with Idera.
Interest expense was $8.6 million
in 2017, compared to $6.5 million in 2016. The increase in interest expense was due primarily to the closing of the Company's
$23 million senior credit facility in September 2016. A $1.8 million mark-to-market loss on the Company's foreign currency
hedge was recognized in 2017, as compared to a $1.7 million mark-to-market loss in 2016. These losses result from periodic changes
in the U.S. dollar/Japanese yen exchange rate. During 2017 and 2016, the Company also realized currency gains of $966,000 and $811,000,
respectively, from the exercise of a U.S. Dollar/Japanese yen currency option within its foreign currency hedge.
Net loss for 2017 was $65.8 million,
or $0.78 per share, compared to a net loss of $55.1 million, or $0.75 per share for the same period last year.
Cash, cash equivalents and investments
totaled $159.0 million at December 31, 2017, and reflect an increase from $65.1 million at December 31, 2016. Net operating cash
use for 2017 was $41.8 million, which excludes $134.0 million of net proceeds from the March and September 2017 public offerings.
Clinical Development Update & Outlook
Financial Outlook for 2018
Based upon development plans and the Company's
awarded government contracts, on a stand-alone basis, BioCryst expects its 2018 net operating cash use to be in the range of $67
to $90 million, and its 2018 operating expenses to be in the range of $85 to $110 million. The Company's 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 the vesting of the Company's outstanding performance-based
Company and Idera File Joint Preliminary Proxy Statement
/ Prospectus and Updated Merger Presentation
The Company also today provided an updated investor presentation
regarding the proposed merger with Idera Pharmaceuticals, which was announced on January 22, 2018. The presentation and a joint
preliminary proxy statement / prospectus were filed today with the U.S. Securities and Exchange Commission (the "SEC"),
and both can be accessed by visiting the "Investors" section of the Company's website at www.BioCryst.com.
Conference Call and Webcast
BioCryst's leadership team will host a
conference call and webcast Tuesday, February 27, 2018 at 11:00 a.m. Eastern Time to discuss these financial results and recent
corporate developments. 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 live or in archived form in the "Investors" section
of the Company's website at www.BioCryst.com. An accompanying slide presentation may also be accessed via the BioCryst website.
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.
Discovered by BioCryst, BCX7353 is a novel,
oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema
attacks in patients diagnosed with HAE. BCX7353 has been generally safe and well tolerated in the Phase 2 APeX-1 clinical trial.
BioCryst is also conducting the ongoing ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing
an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes
and develops novel small-molecule medicines that address both common and rare conditions. BioCryst has several ongoing development
programs including BCX7353, an oral treatment for hereditary angioedema, galidesivir, a potential treatment for filoviruses, and
a preclinical program to develop oral Alk-2 inhibitors for the treatment of fibrodysplasia ossificans progressive (FOP). RAPIVAB
(peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and
has received regulatory approval in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing,
as well as activities to support regulatory approvals in other territories. For more information, please visit the Company's website
at www.BioCryst.com.
Forward-Looking Statements