SAN DIEGO, Nov. 7, 2011 /PRNewswire/ -- Anadys
Pharmaceuticals, Inc. (Nasdaq: ANDS), a biopharmaceutical company
dedicated to improving patient care by developing novel medicines
for the treatment of hepatitis C, today reported its program
highlights and financial results for the third quarter ended
September 30, 2011.
Acquisition by Roche in Progress
- On October 17, 2011, Anadys
announced that it had entered into a definitive merger agreement to
be acquired by Roche (SIX: RO, ROG; OTCQX: RHHBY). Under the terms
of the merger agreement, Roche has commenced an all cash tender
offer for all outstanding shares of common stock of Anadys at
USD 3.70 per share. The tender
offer is expected to close within the fourth quarter of 2011.
"With Roche's considerable capabilities and experience in HCV,
we believe the acquisition of Anadys by Roche provides the best
chance for our development-stage agents to reach patients," said
Steve Worland, Ph.D, President and
CEO of Anadys. "We look forward to an expeditious close and
the continuing advancement of our agents within the Roche
portfolio."
Recent Setrobuvir Program Highlights
- On October 13, 2011, Anadys
released positive interim antiviral response and safety data from
an ongoing Phase IIb study of setrobuvir in combination with
pegylated interferon and ribavirin (P/R) in genotype 1 hepatitis C
patients. Through 12 weeks in the treatment-naïve and prior
partial responders/ relapsers groups, setrobuvir plus P/R
demonstrated strong antiviral response and the incidence of viral
breakthrough rate was low. Response in the partial
responders/ relapsers group was comparable to response in the
treatment-naïve group. Through a median dosing duration of 19
weeks, setrobuvir was generally well tolerated and demonstrated a
favorable safety profile with adverse events comparable to the
control group.
- Setrobuvir was selected by independent experts at Windhover
Information and Herndon Company as one of Windhover's Top 10 Most
Interesting Infectious Disease Projects to Watch. As a selected
company, Anadys will present at Windhover's 6th Annual Therapeutic
Area Partnerships conference November
30-December 2, 2011 in Boston,
MA.
Financial Results and Highlights
As of September 30, 2011, Anadys'
cash, cash equivalents and securities available-for-sale totaled
$19.2 million compared to
$38.0 million as of December 31, 2010. The decrease in cash,
cash equivalents and securities available-for-sale is the result of
cash utilization to fund operations during the first nine months of
2011. Cash utilization during the third quarter totaled
$6.6 million.
Total operating expenses were $9.7
million for the third quarter of 2011, compared to
$4.0 million for the third quarter of
2010. Included as a component of Anadys' operating expenses
were non-cash, share-based expense of $0.4
million and $0.5 million for
the third quarter of 2011 and 2010, respectively.
Research and development expenses were $8.0 million for the third quarter of 2011,
compared to $2.5 million for the
third quarter of 2010. The $5.5
million increase was primarily attributable to a
$5.0 million increase in setrobuvir
development costs and, to a lesser extent, $0.6 million increase in ANA773 development
costs.
General and administrative expenses were $1.7 million for the third quarter of 2011,
compared to $1.5 million for the
third quarter of 2010. This increase can be primarily attributed to
higher legal costs incurred in connection with the Company's
pending merger with Roche.
The net loss was $9.1 million for
the third quarter of 2011, compared to a net loss of $4.7 million for the third quarter of 2010.
Included as a component of net loss were a non-cash gain of
$0.5 million and a non-cash loss of
$0.8 million for the third quarter of
2011 and 2010, respectively, resulting from a decrease (increase)
in the liability associated with our common stock warrants. The
fluctuation in our liability associated with our common stock
warrants is directly attributable to the fluctuation in our stock
price during those periods. The warrants were issued in
connection with a "registered direct" offering in June 2009.
Basic and diluted net loss per common share was $0.16 in the third quarter of 2011, compared to
$0.11 in the third quarter of
2010. Non-cash share-based expense resulted in a $0.01 increase in basic and diluted net loss per
share for the third quarter of 2011 and 2010.
For the nine months ended September 30,
2011, Anadys reported a net loss of $23.2 million, compared to $13.9 million for the same period last
year. Basic and diluted net loss per common share were
$0.41 for the nine months ended
September 30, 2011 compared to
$0.35 for the same period last
year.
Condensed
Consolidated Financial Statements
|
|
|
|
Anadys
Pharmaceuticals, Inc.
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|
Condensed
Consolidated Statements of Operations
|
|
(In
thousands except per share amounts)
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|
(Unaudited)
|
|
|
Three Months
Ended
September 30,
|
Nine Months
Ended
September 30,
|
|
|
2011
|
2010
|
2011
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
7,991
|
|
$
|
2,488
|
|
$
|
19,999
|
|
$
|
9,273
|
|
|
General and
administrative
|
|
1,670
|
|
|
1,510
|
|
|
4,739
|
|
|
4,752
|
|
|
Total operating expenses (1)
|
|
9,661
|
|
|
3,998
|
|
|
24,738
|
|
|
14,025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income and other,
net
|
|
26
|
|
|
22
|
|
|
106
|
|
|
115
|
|
|
Gain (loss) from valuation
of common stock warrant liability
|
|
497
|
|
|
(767)
|
|
|
1,421
|
|
|
(13)
|
|
|
Total other income (expense), net
|
|
523
|
|
|
(745)
|
|
|
1,527
|
|
|
102
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (1)
|
$
|
(9,138)
|
|
$
|
(4,743)
|
|
$
|
(23,211)
|
|
$
|
(13,923)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic
and diluted (1)
|
$
|
(0.16)
|
|
$
|
(0.11)
|
|
$
|
(0.41)
|
|
$
|
(0.35)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating
net loss per share,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
basic and
diluted
|
|
57,176
|
|
|
43,214
|
|
|
57,159
|
|
|
39,970
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
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|
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(1) Includes
non-cash share-based expenses of $433 and $495 or approximately
$0.01 and $0.01 effect on basic and diluted net loss per common
share for the three months ended September 30, 2011 and 2010,
respectively. Research and development expense and general and
administrative expense includes $234 and $199, respectively, of
non-cash share-based expenses for the three months ended September
30, 2011. Research and development expense and general and
administrative expense includes $206 and $289, respectively, of
non-cash share-based expenses for the three months ended September
30, 2010. Includes non-cash share-based expenses of $1,290
and $1,457 or approximately $0.02 and $0.04 effect on basic and
diluted net loss per common share for the nine months ended
September 30, 2011 and 2010, respectively. Research and
development expense and general and administrative expense includes
$606 and $684, respectively, of non-cash share-based expenses for
the nine months ended September 30, 2011. Research and
development expense and general and administrative expense includes
$643 and $814, respectively, of non-cash share-based expenses for
the nine months ended September 30, 2010.
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|
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|
|
Anadys
Pharmaceuticals, Inc.
|
|
Condensed
Consolidated Balance Sheets
|
|
(In
thousands)
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
|
|
2011
|
|
2010
|
|
|
|
|
|
|
(Unaudited)
|
|
(Audited)
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
securities available-for-sale
|
|
$
|
19,164
|
|
$
|
37,984
|
|
Other current
assets
|
|
|
902
|
|
|
1,319
|
|
Noncurrent
assets
|
|
|
107
|
|
|
234
|
|
Total assets
|
|
$
|
20,173
|
|
$
|
39,537
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
$
|
6,912
|
|
$
|
2,970
|
|
Common stock warrant
liability
|
|
|
460
|
|
|
1,881
|
|
Other long-term
liabilities
|
|
|
1
|
|
|
13
|
|
Stockholders'
equity
|
|
|
12,800
|
|
|
34,673
|
|
Total liabilities and stockholders' equity
|
|
$
|
20,173
|
|
$
|
39,537
|
|
|
|
|
|
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About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company
dedicated to improving patient care by developing novel medicines
for the treatment of hepatitis C. The Company believes
hepatitis C represents a large unmet medical need in which
meaningful improvements in treatment outcomes may be attainable
with the introduction of new medicines. Anadys is conducting
a Phase IIb study of setrobuvir (ANA598), the Company's DAA, added
to current standard of care for the treatment of hepatitis C.
The Company is also developing ANA773, the Company's oral,
small-molecule inducer of endogenous interferons that acts via the
Toll like receptor 7, or TLR7, pathway in hepatitis C.
ADDITIONAL INFORMATION AND WHERE TO FIND IT
THE TENDER OFFER DESCRIBED IN THIS PRESS RELEASE HAS COMMENCED,
BUT THIS PRESS RELEASE IS FOR INFORMATIONAL PURPOSES ONLY AND IS
NEITHER AN OFFER TO PURCHASE NOR A SOLICITATION OF AN OFFER TO SELL
SHARES OF ANADYS COMMON STOCK. THE TENDER OFFER IS BEING MADE
PURSUANT TO A TENDER OFFER STATEMENT ON SCHEDULE TO AND RELATED
MATERIALS. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH
THE TENDER OFFER STATEMENT AND RELATED MATERIALS AND THE
SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE TENDER OFFER
BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND
CONDITIONS OF THE OFFER. THE TENDER OFFER STATEMENT AND RELATED
MATERIALS, INCLUDING AN OFFER TO PURCHASE AND LETTER OF
TRANSMITTAL, HAVE BEEN FILED BY ROCHE WITH THE SECURITIES AND
EXCHANGE COMMISSION (SEC), AND THE SOLICITATION/RECOMMENDATION
STATEMENT HAS BEEN FILED BY ANADYS WITH THE SEC. INVESTORS AND
SECURITY HOLDERS MAY OBTAIN A FREE COPY OF THESE STATEMENTS AND
OTHER DOCUMENTS FILED BY ROCHE AND ANADYS WITH THE SEC AT THE
WEBSITE MAINTAINED BY THE SEC AT WWW.SEC.GOV. INVESTORS AND
SECURITY HOLDERS MAY ALSO OBTAIN FREE COPIES OF THE
SOLICITATION/RECOMMENDATION STATEMENT AND THE TENDER OFFER
STATEMENT AND RELATED MATERIALS BY CONTACTING MACKENZIE PARTNERS,
INC., THE INFORMATION AGENT FOR THE TENDER OFFER, AT (800)
322-2885.
Safe Harbor for Forward-Looking Statements
Statements in this press release that relate to future results
and events are forward-looking statements based on Anadys' current
expectations regarding the tender offer and transactions
contemplated by the merger agreement. Actual results and events in
future periods may differ materially from those expressed or
implied by these forward-looking statements because of a number of
risks, uncertainties and other factors. There can be no assurances
that a transaction will be consummated at all or on a timely basis.
Other risks, uncertainties and assumptions include the risk that
Anadys may not satisfy one or more closing conditions, including
because a material adverse event outside the control of Anadys
occurs; that the merger agreement may be terminated; and other
risks that are described in Anadys' most recent Form 10-Q filed
with the Securities and Exchange Commission. Anadys undertakes no
obligation to update these forward-looking statements except to the
extent otherwise required by law.
SOURCE Anadys Pharmaceuticals, Inc.