Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): October 27, 2010
BioCryst Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 000-23186 | 62-1413174 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
4505 Emperor Blvd., Suite 200, Durham, North Carolina 27703
(Address of Principal Executive Offices) (Zip Code)
(Address of Principal Executive Offices) (Zip Code)
(Registrant’s telephone number, including area code): (919) 859-1302
2190 Parkway Lake Drive, Birmingham, Alabama 35244
(Former name or former address, if changed since last report)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
| Item 2.02 Results of Operations and Financial Condition | ||||||||
| Item 7.01 Regulation FD Disclosure | ||||||||
| Item 9.01 Financial Statements and Exhibits | ||||||||
| SIGNATURE | ||||||||
| INDEX TO EXHIBITS | ||||||||
| EX-99.1 | ||||||||
| EX-99.2 | ||||||||
Table of Contents
| Item 2.02 | Results of Operations and Financial Condition. |
On October 28, 2010, BioCryst Pharmaceuticals, Inc. (the “Company”) issued a news release
announcing recent corporate developments and its financial results for the quarter ended September
30, 2010, which also referenced a conference call to discuss these recent corporate developments
and financial results. A copy of the news release is furnished as Exhibit 99.1 hereto and is
incorporated herein by reference.
| Item 7.01 | Regulation FD Disclosure |
On October 27, 2010, the Company issued a news release announcing that its partner, Shionogi & Co.,
Ltd., had received approval of an additional indication for use of intravenous peramivir to treat
children and infants with influenza in Japan. A copy of the news release is furnished as Exhibit
99.2 hereto and is incorporated herein by reference.
The information furnished on Exhibit 99.1 and on Exhibit 99.2 is incorporated by reference under
this Item 7.01 as if fully set forth herein.
The information furnished is not deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not
deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit | ||||
| No. | Description | |||
| 99.1 | Press release dated October 28, 2010 entitled “BioCryst
Reports Third Quarter 2010 Financial Results and Provides
Corporate Update” |
|||
| 99.2 | Press release dated October 27, 2010 entitled “BioCryst’s
Partner Shionogi Receives Pediatric Use Indication for
Peramivir in Japan” |
|||
Table of Contents
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BioCryst Pharmaceuticals, Inc. |
||||
| By: | /s/ Alane Barnes | |||
| Name: | Alane Barnes | |||
| Title: | General Counsel, Corporate Secretary | |||
Date: October 28, 2010
Table of Contents
INDEX TO EXHIBITS
| Exhibit | ||||
| No. | Description | |||
| 99.1 | Press release dated October 28, 2010 entitled “BioCryst
Reports Third Quarter 2010 Financial Results and Provides
Corporate Update” |
|||
| 99.2 | Press release dated October 27, 2010 entitled “BioCryst’s
Partner Shionogi Receives Pediatric Use Indication for
Peramivir in Japan” |
|||
Exhibit 99.1
BIOCRYST REPORTS THIRD QUARTER 2010 FINANCIAL RESULTS AND
PROVIDES CORPORATE UPDATE
PROVIDES CORPORATE UPDATE
Research Triangle Park, North Carolina — October 28, 2010 — BioCryst Pharmaceuticals, Inc.
(NASDAQ:BCRX) today announced financial results for the third quarter and nine months ended
September 30, 2010.
Recent Highlights
| • | BioCryst’s partner Shionogi & Co., Ltd. received approval for an additional indication for use of intravenous (i.v.) peramivir to treat children and infants with influenza in Japan, where it is marketed under the commercial name RAPIACTA®. | ||
| • | In August, Green Cross Corporation received regulatory approval for i.v. peramivir under the commercial name PeramiFlu® in Korea to treat patients with influenza. | ||
| • | In September, BioCryst announced positive results from its Phase 2 study of BCX4208 alone and in combination with allopurinol for the treatment of gout. Lower doses of BCX4208 combined with allopurinol demonstrated synergistic effects in serum uric acid (sUA) reduction. | ||
| • | In September, BioCryst reported results from two oral forodesine studies which demonstrated its clinical activity against cutaneous T-cell lymphoma (CTCL) and chronic lymphocytic leukemia (CLL). |
“We are making strong progress in building BioCryst towards sustainability, on a foundation of new
product approvals, advances in key development programs and emerging opportunities from our
discovery engine,” said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst
Pharmaceuticals. “The market authorizations obtained by our partners, the advancement of the gout
program and the decision to move forward with BCX4161 as a potential novel treatment for hereditary
angioedema all enhance our ability to create value over the short- and long-term.”
Third Quarter Financial Results
For the three months ended September 30, 2010, total revenues increased to $12.0 million compared
to $10.5 million for the three months ended September 30, 2009. This $1.5 million increase was
driven by higher revenue from the contract with the Department of Health &
Human Services (HHS) for
the continued development of i.v. peramivir, offset by lower revenue from the Company’s
collaboration with Shionogi & Co., Ltd.
Research and development (R&D) expenses increased to $19.2 million for the third quarter of 2010
from $18.2 million in the same quarter of last year. This increase was driven by higher
development costs of $2.8 million associated with the BCX4208 program for the treatment of gout,
partially offset by decreases in development costs of $1.9 million associated with the forodesine
and peramivir clinical programs.
General and administrative (G&A) expenses increased to $3.8 million for the third quarter of 2010
from $3.1 million in the same quarter as last year. This increase was primarily due to higher
consulting fees and personnel related costs.
The Company’s net loss for the three months ended September 30, 2010 was $10.9 million, or $0.24
per share, compared to a net loss of $10.6 million, or $0.28 per share for the three months ended
September 30, 2009.
Year to Date Financial Results
For the nine months ended September 30, 2010, total revenues increased to $45.7 million compared to
$19.7 million for the nine months ended September 30, 2009. This $26.0 million increase was driven
primarily by a $12.4 million increase in revenue from the contract with HHS, as well as the receipt
of a $7.0 million milestone payment from the Company’s partner, Shionogi and the sale of $6.4
million of peramivir active pharmaceutical ingredient (API) to collaborators Shionogi and Green
Cross Corp. during the first quarter 2010.
R&D expenses increased to $58.9 million for the first nine months of 2010 from $40.7 million in the
same period as last year. The $18.2 million increase was primarily due to an increase of $6.5
million in development costs associated with the peramivir program, $6.3 million of manufacturing
costs related to production of peramivir API for Shionogi and Green Cross Corp., $6.3 million in
higher development costs associated with the BCX4208 program and $1.0 million in higher
pre-clinical program costs. These increases in R&D expenses were partially offset by a decrease of
$2.1 million in development costs associated with the forodesine program.
G&A expenses increased to $10.8 million for the nine months ended September 30, 2010 from $7.8
million for the nine months ended September 30, 2009, primarily due to increases in consulting fees
and personnel related costs.
The net loss for the nine months ended September 30, 2010 was $23.7 million, or $0.53 per share,
compared to a net loss of $28.6 million, or $0.75 per share for the nine months ended September 30,
2009.
As of September 30, 2010, the Company held cash, cash equivalents and securities of $72.0 million,
a decrease of $22.2 million as compared to December 31, 2009.
During the August 2010 quarterly update, we projected 2010 cash use to be within, but at the high
end of its previous guidance range of $25 to $30 million. Initiation of the modified Phase 3
program for peramivir will lead to a ramp up in development expenses during the fourth quarter of
2010. This creates a timing effect on our 2010 cash use, as these expenses will be reimbursed
by HHS during the first quarter of 2011. As a result, we now expect our cash use for 2010 to be
approximately $33 million.
Clinical Development Update & Outlook
| • | The Phase 2 study to evaluate the efficacy and safety of BCX4208 alone and in combination with allopurinol in gout patients met its primary endpoint related to sUA reduction. A dose-response was demonstrated for both BCX4208 and allopurinol, and the combination of BCX4208 and allopurinol was shown to be superior to either drug alone in sUA reduction. In five of these nine combination groups, 80 percent or more of the patients achieved a sUA concentration of less than 6 mg/dL. Combinations of lower doses of BCX4208 with allopurinol showed synergistic effects in sUA reduction. The doses of BCX4208 alone and in combination with allopurinol evaluated in the study were generally safe and well-tolerated. | |
| • | In the pivotal Phase 2 study of 200 mg once-daily forodesine in the treatment of CTCL, eleven percent of late-stage patients (Stage IIB to IVA) achieved a partial cutaneous response. An interim analysis of the ongoing exploratory Phase 2 study evaluating 200 mg of forodesine twice-daily in 25 patients with CLL showed that three patients demonstrated a confirmed partial response to forodesine. Final results from this study are expected later in 2010, and the Company plans to present these results at an upcoming medical meeting. BioCryst is exploring the interest level of potential partners as a possible path forward for the future development of forodesine in the U.S. | |
| • | BioCryst has submitted a contract modification to HHS/Biomedical Advanced Research and Development Authority (BARDA), to include an additional efficacy study and Government funding to complete the Phase 3 development of i.v. peramivir. Start-up activities for the upcoming flu season have been approved by HHS/BARDA under the existing contract and are underway. | |
| • | BioCryst has recently presented new clinical safety and influenza B virologic data for i.v. peramivir at two medical meetings, ICAAC and IDSA. | |
| • | BioCryst is finalizing plans for a 12 week, randomized, controlled study of BCX4208 as add-on therapy in gout patients who have failed to adequately respond to allopurinol. The 200+ subject study is expected to begin enrollment in early 2011. The Company also plans to initiate a long-term safety study in 2011. | |
| • | During BioCryst’s Investor Day event in September, the Company announced plans to conduct additional pre-clinical development activities to support the advancement of BCX4161 as a potential novel plasma kallikrein inhibitor for the treatment of hereditary angioedema. |
Conference Call and Web Cast
BioCryst’s management team will host a conference call and Web cast on Thursday, October 28, 2010
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 Web
cast can be accessed by logging onto http://www.biocryst.com. Please connect to the Web site 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
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that
block key enzymes involved in infectious diseases, inflammatory diseases and cancer. BioCryst
currently has three novel late-stage compounds in development: peramivir, a neuraminidase inhibitor
for the treatment of influenza, BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor for the
treatment of gout, and forodesine, an orally-available PNP inhibitor for hematological
malignancies. Utilizing crystallography and structure-based drug design, BioCryst continues to
discover additional compounds and to progress others through pre-clinical and early development to
address the unmet medical needs of patients and physicians. For more information, please visit the
Company’s Web site 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 our 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 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: that to the
extent peramivir is used as a treatment for H1N1 flu (or other strains of flu), there can be no
assurance that it will prove effective; that HHS may further condition, reduce or eliminate future
funding of the peramivir program; that ongoing peramivir clinical trials or our peramivir program
in general may not be successful; that development and commercialization of forodesine may not be
successful; that ongoing and future pre-clinical and clinical development of BCX4208 may not have
positive results; that we or our licensees may not be able to enroll the required number of
subjects in planned clinical trials of our product candidates and that such clinical trials may not
be successfully completed; that BioCryst or its licensees may not commence as expected additional
human clinical trials with our product candidates; that our product candidates may not receive
required regulatory clearances from the FDA; that ongoing and future pre-clinical and clinical
development may not have positive results; that we or our licensees may not be able to continue
future development of our current and future development programs; that our development programs
may never result in future product, license or royalty payments being received by BioCryst; that
BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for
further development of its
product candidates or it may not reach favorable agreements with
potential pharmaceutical and biotechnology partners for further development of its product
candidates; that our actual cash burn rate may not be consistent with our expectations; that
BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing
or distribution of its products
and that additional funding, if necessary, may not be available at all or on terms acceptable to
BioCryst. 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 our projections and
forward-looking statements.
###
BCRXW
CONTACT:
|
Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910 (Investors) Catherine Kyroulis, WCG, +1-212-301-7174 (Media) |
BIOCRYST PHARMACEUTICALS, INC.
FINANCIAL SUMMARY
FINANCIAL SUMMARY
Statements of Operations (Unaudited)
(in thousands, except per share)
(in thousands, except per share)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenues: |
||||||||||||||||
Product sales |
$ | — | $ | — | $ | 325 | $ | — | ||||||||
Royalties |
— | — | 711 | — | ||||||||||||
Collaborative and other research and development |
12,000 | 10,548 | 44,651 | 19,694 | ||||||||||||
Total revenues |
12,000 | 10,548 | 45,687 | 19,694 | ||||||||||||
Expenses: |
||||||||||||||||
Cost of products sold |
— | — | 86 | — | ||||||||||||
Research and development |
19,197 | 18,181 | 58,851 | 40,683 | ||||||||||||
General and administrative |
3,793 | 3,064 | 10,799 | 7,834 | ||||||||||||
Total expenses |
22,990 | 21,245 | 69,736 | 48,517 | ||||||||||||
Loss from operations |
(10,990 | ) | (10,697 | ) | (24,049 | ) | (28,823 | ) | ||||||||
Interest and other income |
126 | 70 | 397 | 220 | ||||||||||||
Net loss |
$ | (10,864 | ) | $ | (10,627 | ) | $ | (23,652 | ) | $ | (28,603 | ) | ||||
Basic and diluted net loss per common share |
$ | (0.24 | ) | $ | (0.28 | ) | $ | (0.53 | ) | $ | (0.75 | ) | ||||
Weighted average shares outstanding |
44,884 | 38,460 | 44,445 | 38,300 | ||||||||||||
Balance Sheet Data (in thousands)
| September 30, 2010 | December 31, 2009 | |||||||
| (Unaudited) | (Note 1) | |||||||
Cash, cash equivalents and
securities |
$ | 72,042 | $ | 94,259 | ||||
Receivables from collaborations |
25,564 | 33,722 | ||||||
Total assets |
111,354 | 142,190 | ||||||
Accumulated deficit |
(286,372 | ) | (262,720 | ) | ||||
Stockholders’ equity |
74,349 | 86,266 | ||||||
Note 1: Derived from audited financial statements.
Exhibit 99.2
BIOCRYST’S PARTNER SHIONOGI RECEIVES APPROVAL FOR PEDIATRIC USE OF PERAMIVIR IN JAPAN
Research Triangle Park, North Carolina — October 27, 2010 — BioCryst Pharmaceuticals, Inc.
(NASDAQ:BCRX) today announced that its partner, Shionogi & Co., Ltd. has received approval for an
additional indication for use of intravenous (i.v.) peramivir to treat children and infants with
influenza in Japan. In January 2010, Shionogi received the world’s first approval for i.v.
peramivir and launched it under the commercial name RAPIACTA® in Japan. It was
initially approved for the treatment of adults with uncomplicated seasonal influenza, as well as
those at high-risk for complications associated with influenza.
“We congratulate Shionogi on receiving the expanded approval for pediatric use of i.v.
peramivir in Japan. Parents and medical practitioners in Japan desire an additional option to
treat pediatric influenza infections, as children with influenza can be at risk of severe symptoms
and complications,” said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst.
“BioCryst is currently advancing its Phase 3 i.v. peramivir studies toward completion, with the
goal of regulatory filing for approval in the U.S.”
Shionogi has stated it intends to secure an adequate supply of RAPIACTA® to treat
approximately 1,000,000 people during the upcoming influenza season. In addition, Shionogi is
taking steps to ensure its manufacturing capability and a stable supply to meet urgent demands.
About peramivir
Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly
delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir
inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of
influenza within a host. In laboratory tests, peramivir has shown activity against multiple
influenza strains, including pandemic H1N1 swine origin flu viral strains. In January 2010,
Shionogi & Co., Ltd. launched intravenous (i.v.) peramivir in Japan under the name
RAPIACTA® to treat patients with influenza and in August 2010, Green Cross Corporation
announced that it had received marketing and manufacturing authorization for i.v. peramivir in
Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more
information about peramivir please visit BioCryst’s Web site at http://www.biocryst.com/peramivir.
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that
block key enzymes involved in infectious diseases, inflammatory diseases and cancer. BioCryst
currently has three novel late-stage compounds in development: peramivir, a neuraminidase inhibitor
for the treatment of influenza, BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor for the
treatment of gout, and forodesine, an orally-available PNP inhibitor for hematological
malignancies. Utilizing crystallography and structure-based drug design, BioCryst continues to
discover additional compounds and to progress others through pre-clinical and early development to
address the unmet medical needs of patients and physicians. For more information, please visit the
Company’s Web site 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 our 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 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:
that to the extent peramivir is used as a treatment for H1N1 flu (or other strains of flu), there
can be no assurance that it will prove effective; that HHS may further condition, reduce or
eliminate future funding of the peramivir program; that ongoing peramivir clinical trials or our
peramivir program in general may not be successful; that we or our licensees may not be able to
enroll the required number of subjects in planned clinical trials of our product candidates and
that such clinical trials may not be successfully completed; that BioCryst or its licensees may not
commence as expected additional human clinical trials with our product candidates; that our product
candidates may not receive required regulatory clearances from the FDA; that ongoing and future
pre-clinical and clinical development may not have positive results; that we or our licensees may
not be able to continue future development of our current and future development programs; that our
development programs may never result in future product, license or royalty payments being received
by BioCryst; that BioCryst may not be able to retain its current pharmaceutical and biotechnology
partners for further development of its product candidates or it may not reach favorable agreements
with potential pharmaceutical and biotechnology partners for further development of its product
candidates; that our actual cash burn rate may not be consistent with our expectations; that
BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing
or distribution of its products and that additional funding, if necessary, may not be available at
all or on terms acceptable to BioCryst. 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
our projections and forward-looking statements.
###
BCRXW |
||
CONTACT:
|
Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910 (investors) Catherine Collier Kyroulis, WCG, +1-212-301-7174 (media) |