Exhibit 99.1
(ANADYS PHARMACEUTICALS, INC. LOGO)
CONTACT:
Michael Kamdar Trista Morrison
Sr. VP, Corporate Development and Finance Media Relations
Anadys Pharmaceuticals, Inc. Atkins + Associates
(858) 530-3667 (858) 527-3490
cc@anadyspharma.com tmorrison@irpr.com
ANADYS PHARMACEUTICALS REPORTS FIRST QUARTER 2004 FINANCIAL RESULTS
Initial Public Offering Occurred in March 2004
SAN DIEGO, CA, MAY 13, 2004 - Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), a
biopharmaceutical company committed to advancing patient care by discovering,
developing and commercializing novel small molecule, anti-infective medicines
for the treatment of hepatitis C virus, hepatitis B virus and bacterial
infections, today reported its financial results for the quarter ended March 31,
2004.
"The first quarter of 2004 was very productive for Anadys. We continued to
advance our clinical and pre-clinical programs surrounding the isatoribine
family of compounds, including the continuation of the on-going clinical trial
of isatoribine itself. Interim results of the isatoribine study have
demonstrated proof of concept through hepatitis C virus reduction. In addition,
we have initiated clinical trials of the first oral prodrug of isatoribine,"
said Kleanthis G. Xanthopoulos, Ph.D., Anadys' President and Chief Executive
Officer. "The isatoribine family of compounds continues to be a significant
focus of our development efforts. We are on track to nominate a second oral
prodrug of isatoribine, with optimized pharmaceutical properties, during the
second quarter of 2004. We also are advancing our discovery programs to continue
building a pipeline of compounds for the treatment of HCV, HBV and antibacterial
infections. Our achievements during the first quarter culminated in our initial
public offering, which closed on March 31, 2004."
RECENT HIGHLIGHTS
- Anadys initiated a Phase I clinical trial of ANA971, its first oral
prodrug of isatoribine. Anadys previously announced interim results
from an on-going clinical trial of isatoribine which established
proof of concept that a compound interacting with TLR-7 can reduce
viral load in HCV infected patients.
- Anadys exercised an exclusive option with LG Life Sciences ("LGLS")
and entered into a joint development and license agreement with LGLS
for the global development of ANA380 (LB80380), a compound for the
treatment of HBV infection, which is currently in Phase II clinical
trials.
- Anadys announced the achievement of its first research milestone
under its drug discovery collaboration with Amgen.
- Anadys closed its initial public offering of common stock, raising
gross proceeds of approximately $49 million.
- Anadys and LGLS recently announced the completion of a Phase I/IIa
clinical trial of ANA380 (LB80380), results of which provide further
encouragement for the continued development of ANA380 (LB80380) as a
therapy for chronic HBV infection.
FINANCIAL RESULTS
The Company reported revenues of $683,000 for the first quarter of 2004 compared
to $562,000 for the first quarter of 2003. The net loss applicable to common
stockholders was $7.6 million for the first quarter of 2004, compared with the
net loss applicable to common stockholders of $7.7 million for the same period
in the prior year. Basic and diluted net loss per common share was $3.77 in the
first quarter of 2004, compared to $6.00 for the same period in 2003. Pro forma
basic and diluted net loss per common share (assuming that the conversion of
preferred stock to common stock that was automatically effected in conjunction
with the IPO took place as of the original date of issuance) was $0.49 in the
first quarter of 2004, compared to $0.56 for the same period in 2003.
Cash, cash equivalents and securities available-for-sale totaled $51.1 million
at March 31, 2004 compared to $14.5 million as of December 31, 2003, an increase
of $36.6 million. This increase resulted primarily from our initial public
offering of 6,250,000 shares of common stock for proceeds to us of $39.0
million, net of underwriting discounts and offering expenses. In addition on
March 31, 2004, we closed the sale of an additional 215,000 shares of our common
stock pursuant to the exercise by the underwriters of an over-allotment option
which resulted in additional net proceeds to us of $1.4 million. Subsequent to
March 31, 2004, we sold an additional 528,950 shares of common stock pursuant to
the exercise by the underwriters of the over-allotment option, bringing the
total net proceeds from the initial public offering to $43.9 million.
Anadys will be hosting both a conference call and webcast to discuss first
quarter 2004 financial results and highlights from the quarter on Thursday, May
13, 2004, at 4:30 PM Eastern Time (1:30 PM Pacific Time).
To access the webcast via the Internet, log on to www.anadyspharma.com under the
"Investor Relations" section of the website. Please connect to the company's
website at least 15 minutes prior to the conference call to ensure adequate time
for any software download that may be needed to hear the webcast. Alternatively,
please call 1-800-901-5213 (U.S.) or 1-617-786-2962 (international) and dial the
participant passcode 35481348 to access the call. Telephone replay is available
approximately two hours after the call through May 20, 2004. To access, please
call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international) and dial the
participant passcode 94909363. The webcast will be archived on
www.anadyspharma.com through May 31, 2004.
Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical
company committed to advancing patient care by discovering, developing and
commercializing novel small molecule, anti-infective medicines for the treatment
of hepatitis C virus, hepatitis B virus and bacterial infections. Anadys is
advancing its anti-infective portfolio through the development of its two
clinical programs, the isatoribine family of compounds and ANA380. In addition,
Anadys' anti-infective therapeutic platform is designed to advance a strong and
continual pipeline of drug candidates into the clinic.
SAFE HARBOR STATEMENT
Statements in this press release that are not strictly historical in nature
constitute "forward-looking statements." Anadys cautions investors not to place
undue reliance on the forward-looking statements contained in this press
release, which speak only as of the date hereof. Such statements include, but
are not limited to references to the believed mechanism of action of
isatoribine, expectations regarding timing of future pre-clinical and clinical
milestones, activities expected to occur in connection with Anadys' business
relationship with LGLS, the effects of administration of ANA380 (LB80380) in HBV
infected patients and Anadys' ability to maintain its drug development pipeline.
Such forward-looking statements involve known and unknown risks, uncertainties
and other factors which may cause the actual results of Anadys to be materially
different from historical results or from any results expressed or implied by
such forward-looking statements. In particular, the results of initial clinical
trials may not be
predictive of future results. In addition, Anadys' results may be affected by
risks related to implementation of its relationship with LG Life Sciences, Ltd.,
competition from other biotechnology and pharmaceutical companies, its
effectiveness at managing its financial resources, its ability to successfully
develop and market products, difficulties or delays in its clinical trials,
difficulties or delays in manufacturing its clinical trials materials, the scope
and validity of patent protection for its products, regulatory developments
involving future products and its ability to obtain additional funding to
support its operations. These and other factors that may cause actual results to
differ are detailed in greater detail in Anadys' Securities and Exchange
Commission filings, including Anadys' Prospectus filed on March 26, 2004. All
forward-looking statements are qualified in their entirety by this cautionary
statement, and Anadys undertakes no obligation to revise or update any
forward-looking statements contained in this document as a result of new
information, future events or otherwise.
ANADYS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
THREE MONTHS ENDED MARCH 31,
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2004 2003
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Revenues $ 683 $ 562
Operating expenses 8,083 8,147
Interest income (expense) (42) 37
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Net loss (7,442) (7,548)
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Accretion to redemption value of
redeemable convertible preferred
stock (175) (165)
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Net loss applicable to common stockholders $ (7,617) $ (7,713)
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Net loss per share, basic and diluted $ (3.77) $ (6.00)
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Shares used in calculating net loss per share,
basic and diluted 2,021 1,285
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Pro forma net loss per share, basic and diluted $ (0.49) $ (0.56)
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Pro forma shares used in calculating net loss
per share, basic and diluted 15,154 13,382
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In connection with our initial public offering each share of Series C redeemable
convertible preferred stock was automatically converted to common stock at a
ratio of one share of common stock for 5.10 shares of preferred stock. Each
share of Series A-1, A-2, A-3, A-4, A-5, and B of convertible preferred stock
was automatically converted to common stock at a ratio of one share of common
stock for approximately 11.92, 11.92, 10.62, 7.38, 3.36, and 2.35 shares of
preferred stock, respectively. Accordingly, pro forma basic and diluted net loss
per common share has been calculated assuming the preferred stock was converted
as of the original date of issuance of the preferred stock.
ANADYS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
MARCH 31, DECEMBER 31,
2004 2003
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(UNAUDITED) (AUDITED)
Assets
Cash, cash equivalents and securities
available-for-sale $ 51,088 $ 14,499
Other current assets 816 1,693
Noncurrent assets 3,768 4,050
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Total assets $ 55,672 $ 20,242
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Liabilities and stockholders' equity
Current liabilities $ 3,883 $ 3,888
Long-term liabilities 1,325 1,401
Redeemable convertible preferred stock -- 45,012
Stockholders' equity 50,464 (30,059)
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Total liabilities and stockholders' equity $ 55,672 $ 20,242
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