Exhibit
99.1
CONTACT:
Pamela L. Dull, Sonus Pharmaceuticals, Inc., (425) 487-9500, Ext. 255
SONUS PHARMACEUTICALS
HIGHLIGHTS CORPORATE PROGRESS AND REPORTS THIRD QUARTER FINANCIAL RESULTS
Company achieves key milestones
in TOCOSOL® Paclitaxel development
Quarterly
conference call today at 1:30 P.M. PT/4:30 P.M. ET
BOTHELL,
Washington, November 8, 2005—Sonus Pharmaceuticals, Inc.
(NASDAQ:SNUS) today reported financial results for the third quarter ended
September 30, 2005 and updated year-to-date progress on 2005 strategic
objectives, including the clinical and regulatory development of TOCOSOL® Paclitaxel,
the Company’s lead oncology candidate.
“During the third quarter and recent weeks,
we continued to make very strong progress with the development of TOCOSOL
Paclitaxel,” said Michael A. Martino, president and chief executive officer of
Sonus Pharmaceuticals. “Following completion
of a Special Protocol Assessment with the FDA in June, we initiated the pivotal
Phase 3 trial of TOCOSOL Paclitaxel in September for the potential treatment of
metastatic breast cancer. Our goal is to
complete patient enrollment in this trial within one year. We recently entered into a global licensing
agreement for TOCOSOL Paclitaxel with Schering AG (known as Berlex in the
U.S.). We believe this collaboration is
an outstanding strategic fit that puts our two companies in the strongest
possible position to develop TOCOSOL Paclitaxel on a global basis and maximize its
commercial potential.”
Corporate Highlights:
• Announced partnership agreement
with Schering AG for TOCOSOL Paclitaxel, consisting of an equity purchase
agreement and a worldwide, exclusive license agreement.
— Under the purchase
agreement, Schering has taken a 15% ownership position in Sonus with an equity
investment of $15.7 million (3.9 million shares at a market price of $4.02) and
acquired five-year warrants to purchase 975,000 additional shares of Sonus
common stock at an exercise price of $4.42.
More...
— Under the terms
of the worldwide licensing agreement, which is subject to Hart-Scott-Rodino
(HSR) regulatory clearance:
• Schering has paid Sonus an
upfront fee of $20 million (in escrow pending HSR clearance).
• Sonus and Schering will
equally share the costs of the pivotal Phase 3 trial in metastatic breast
cancer as well as additional trials to support launch of the product in the
U.S. The two companies may also pursue
other trials for TOCOSOL Paclitaxel. The
design and cost of these trials will be determined by a joint Steering Committee
who will prioritize and oversee the development and commercialization of
TOCOSOL Paclitaxel.
• Schering will fund all
clinical trials required to gain regulatory approvals outside the U.S.
• Sonus will receive up to
$132 million upon the achievement of certain clinical and regulatory milestones
in the U.S., the European Union and Japan.
• Upon U.S. commercialization,
Schering will pay Sonus royalties of 15% to 30% on net sales, depending on the
level of sales achieved. For sales
outside the U.S., Sonus will receive royalties of 15%.
• Sonus may also receive
one-time sales milestone payments up to $35 million if specific annual global
sales thresholds are reached.
• Initiated pivotal Phase 3
trial of TOCOSOL Paclitaxel in September 2005.
This trial is intended to serve as the basis for approval of the product
by the FDA. The trial will enroll
approximately 800 women with metastatic breast cancer, who will receive either
TOCOSOL Paclitaxel or Taxol® on a weekly dosing schedule. Patients will be enrolled at clinical sites
in North America, Western and Eastern Europe, South Africa and Israel.
• Continued to advance
preclinical development of the Company’s second oncology product candidate, a proprietary
camptothecin compound, designated as SN2310 Emulsion. Formulated with Sonus’ TOCOSOL technology,
SN2310 is a novel conjugate of SN38, the active metabolite of irinotecan, which
is a marketed camptothecin product. SN2310
Emulsion is intended to provide a prolonged circulation time and greater
exposure to active drug, which may lead to better anti-tumor effect. Encouraging preclinical results for SN2310
Emulsion will be presented on November 15 at the AACR-NCI-EORTC international
cancer conference in Philadelphia. Camptothecins
are an important and rapidly growing class of anti-cancer drugs that are
currently used in the treatment of colon, lung and ovarian cancers.
2
Third Quarter Financial Results
For the third quarter of 2005, Sonus reported
a net loss of $8.9 million, or $0.37 per share, compared with a net loss of
$3.6 million, or $0.17 per share, for the third quarter of 2004. For the first nine months of 2005, the
Company reported a net loss of $17.8 million, or $0.80 per share, compared with
a net loss of $11.0 million, or $0.55 per share for the same period of
2004. The higher net loss for the
year-to-date financial results primarily reflected an increased level of
spending as Sonus continues to execute the clinical and regulatory plans for TOCOSOL
Paclitaxel.
During the third quarter, the Company strengthened its balance sheet
with the completion of a private placement in August that generated net
proceeds of $16.6 million. Cash and
marketable securities totaled $23.4 million at September 30, 2005. Sonus expects that its net cash burn rate
will average approximately $1.8 million per month in 2005, including expenses
related to the Phase 3 pivotal trial for TOCOSOL Paclitaxel.
Conference Call
Information
The third quarter
conference call will be web cast live on November 8, 2005 at 1:30 Pacific
Time/4:30 P.M. Eastern Time and can be accessed at
www.sonuspharma.com/events.html. An
archive of the call will be available through the same link. A telephone replay will be available from
November 8, 4:30 P.M. Pacific Time/7:30 P.M. Eastern Time, for one week at
(800) 405-2236 or (303) 590-3000 for international calls; Conference ID
11041345.
About Sonus Pharmaceuticals
Headquartered near Seattle, Sonus
Pharmaceuticals, Inc. is focused on the development of novel drugs for the
oncology market that may offer improved administration, tolerability, safety
and effectiveness. The Company’s lead
product candidate is TOCOSOL Paclitaxel, a new formulation of the widely
prescribed anti-cancer drug paclitaxel.
TOCOSOL Paclitaxel has shown promising safety and anti-tumor activity in
Phase 2 clinical trials in a variety of solid tumors, including breast, lung,
ovarian and bladder cancers, and the product is currently in a Phase 3 pivotal
study for the potential treatment of metastatic breast cancer. Sonus recently announced the signing of a
development and commercialization agreement for TOCOSOL Paclitaxel with
Schering AG, a worldwide leader in the pharmaceutical industry. For additional information on Sonus,
including news releases, please visit www.sonuspharma.com.
3
Safe Harbor
Certain statements made in this press release
are forward-looking such as those, among others, relating to the development, safety
and efficacy of drug delivery products and potential applications for these
products. As discussed in Sonus
Pharmaceuticals’ filings with the Securities and Exchange Commission, including
its Annual Report on Form 10-K filed on March 23, 2005 and Form 10-Qs for the
first two quarters of 2005, actual results could differ materially from those
projected in the forward-looking statements as a result of the following
factors, among others: the Company’s
products will require extensive clinical testing and approval by regulatory
authorities; such approvals are lengthy and expensive and may never occur;
risks that the Company will not be able to complete the Phase 3 clinical trial
for TOCOSOL Paclitaxel; risks that clinical studies with TOCOSOL Paclitaxel will
not be successful; risks that the FDA may not approve the Company’s proposed
New Drug Application; risks of successful development of additional drug
delivery products; risks that the Company may not be successful in obtaining
funding from third parties or completing a financing necessary to support the
costs and expenses of clinical studies as well as research and development
activities; and risks that the Company will not obtain regulatory clearance of
the license agreement with Schering AG under the Hart-Scott-Rodino Antitrust
Improvements Act. The Company undertakes
no obligation to update the forward-looking statements contained herein or to
reflect events or circumstances occurring after the date hereof.
###
Taxol® is a registered trademark of
Bristol-Myers Squibb Company.
4
Condensed Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
2005
|
|
2004
|
|
2005
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
7,979
|
|
2,401
|
|
13,971
|
|
7,630
|
|
|
General and administrative
|
|
1,064
|
|
1,291
|
|
4,102
|
|
3,493
|
|
|
Total operating expenses
|
|
9,043
|
|
3,692
|
|
18,073
|
|
11,123
|
|
|
Operating loss
|
|
(9,043
|
)
|
(3,692
|
)
|
(18,073
|
)
|
(11,123
|
)
|
|
Other income, net
|
|
135
|
|
80
|
|
299
|
|
171
|
|
|
Loss before income taxes
|
|
(8,908
|
)
|
(3,612
|
)
|
(17,774
|
)
|
(10,952
|
)
|
|
Income taxes
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|
Net loss
|
|
$
|
(8,908
|
)
|
$
|
(3,612
|
)
|
$
|
(17,774
|
)
|
$
|
(10,952
|
)
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.37
|
)
|
$
|
(0.17
|
)
|
$
|
(0.80
|
)
|
$
|
(0.55
|
)
|
|
Diluted
|
|
$
|
(0.37
|
)
|
$
|
(0.17
|
)
|
$
|
(0.80
|
)
|
$
|
(0.55
|
)
|
|
Shares used in
calculation:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
23,832
|
|
21,313
|
|
22,187
|
|
19,776
|
|
|
Diluted
|
|
23,832
|
|
21,313
|
|
22,187
|
|
19,776
|
|
Condensed
Balance Sheets
(in
thousands)
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
2005
|
|
2004
|
|
|
|
|
(unaudited)
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
Cash and marketable securities
|
|
$
|
23,443
|
|
$
|
20,580
|
|
|
Other current assets
|
|
141
|
|
459
|
|
|
Property and equipment, net
|
|
1,108
|
|
1,480
|
|
|
Other assets
|
|
52
|
|
52
|
|
|
Total assets
|
|
$
|
24,744
|
|
$
|
22,571
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity:
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
5,493
|
|
3,177
|
|
|
Lease obligations
|
|
49
|
|
121
|
|
|
Deferred rent
|
|
148
|
|
196
|
|
|
Stockholders’ equity
|
|
19,054
|
|
19,077
|
|
|
Total liabilities and
stockholders’ equity
|
|
$
|
24,744
|
|
$
|
22,571
|
|
5