UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1
on
FORM 8-K/A
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 12, 2005
XOMA LTD.
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(Exact name of registrant as specified in its charter)
BERMUDA
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(State or other jurisdiction of incorporation)
0-14710 52-2154066
(Commission File Number) (IRS Employer Identification No.)
2910 Seventh Street, Berkeley, California 94710
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(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code (510) 204-7200
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(Former name or former address, if changed since last report)
Item 1.01. Entry into a Material Definitive Agreement
On January 21, 2005, XOMA Ltd. announced additional details about the
accounting treatment and financial impact of the recent restructuring of its
RAPTIVA(R) agreement with Genentech, Inc., which took effect January 1, 2005.
A copy of the press release is attached hereto as Exhibit 2 and is
incorporated herein by reference.
Item 9.01. Exhibits
1. Press Release dated January 12, 2005.*
2. Press Release dated January 21, 2005.
____________________________
* Previously filed.
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 hereunto duly authorized.
Dated: January 21, 2005 XOMA LTD.
By: /s/ Christopher J. Margolin
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Christopher J. Margolin
Vice President, General
Counsel and Secretary
EXHIBIT INDEX
Number Description
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1. Press Release dated January 12, 2005.*
2. Press Release dated January 21, 2005.
____________________________
* Previously filed.
Exhibit 2
Investor and Media Contacts:
Ellen M. Martin
Kureczka/Martin Associates
Investor Relations
Tel: (510) 832-2044
Deb McManus, APR
Media
(510) 204-7240
XOMA PROVIDES FURTHER DETAILS OF THE ACCOUNTING IMPACT OF
CHANGES TO RAPTIVA(R) ARRANGEMENT
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BERKELEY, CA - January 21, 2005 - XOMA Ltd. (NASDAQ: XOMA) today announced
additional details about the accounting treatment and financial impact of the
recent restructuring of its RAPTIVA(R) agreement with Genentech, Inc., which
took effect January 1, 2005.
o The discharge of the $40 million development loan plus accrued
interest will be recognized by XOMA as income in the first quarter of
2005.
o The overall RAPTIVA(R) impact included in XOMA's reported statement of
operations for the nine month period ended September 30, 2004 was a
net expense of approximately $16.0 million, which consisted of
collaboration agreement expense of $12.3 million, research and
development expense of an additional $3.0 million, and interest
expense of $0.7 million. XOMA has previously stated that it
anticipated additional losses on RAPTIVA(R) beyond the third quarter
of 2004. Under the terms of the new agreement, XOMA will be entitled
to royalties on worldwide sales of RAPTIVA(R) beginning in the first
quarter of 2005, and will be compensated by Genentech for any future
RAPTIVA(R) development work that is requested. There will be no
further collaboration agreement expense or interest expense on the
development loan.
"Because of the importance of the restructuring of this agreement to XOMA's
financial results, we felt it would be helpful to give investors a clearer
picture of the positive financial impact compared with previously reported
trends," said Peter B. Davis, chief financial officer of XOMA. "As we have
stated pre-
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viously, this restructuring will immediately benefit our financial results
beginning in the first quarter of 2005, by making RAPTIVA(R) profitable to XOMA
and by strengthening our balance sheet. This is an important step in our goal of
making XOMA profitable within three years."
- About XOMA
XOMA is a biopharmaceutical company focused on the development and
commercialization of antibody and other protein-based biopharmaceuticals for
disease targets that include cancer, immunological and inflammatory disorders,
and infectious diseases. XOMA's proprietary and collaborative product
development programs include: RAPTIVA(R) for moderate to severe plaque psoriasis
(marketed) and other indications with Genentech, Inc.; MLN 2222, a recombinant
protein for reducing the incidence of post-operative events in coronary artery
bypass graft surgery patients with Millennium Pharmaceuticals, Inc. (Phase I);
CHIR-12.12, an anti-CD40 antibody for treating B-cell tumors and additional
product candidates in connection with an antibody oncology collaboration with
Chiron Corporation (preclinical); a TPO mimetic antibody to treat
chemotherapy-induced thrombocytopenia in collaboration with Alexion
Pharmaceuticals, Inc. (preclinical); and anti-gastrin antibody product
candidates in conjunction with the antibody collaboration for the treatment of
gastrointestinal cancers with Aphton Corporation (preclinical). Licensing
agreements include: ING-1, XOMA's proprietary, anti-tumor monoclonal antibody
for the treatment of various adenocarcinomas in conjunction with a licensing
arrangement with Triton BioSystems, Inc.; and XOMA's
bactericidal/permeability-increasing protein (BPI), including NEUPREX, for
product commercialization in conjunction with an exclusive licensing agreement
with Zephyr Sciences, Inc. For more information about XOMA's product pipeline
and antibody product development capabilities and technologies, please visit
XOMA's website at http://www.xoma.com/.
Certain statements contained herein concerning the Company's potential for
profitability and future sales of RAPTIVA(R), or that otherwise relate to future
periods, are forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
These statements are based on assumptions that may not prove accurate. Actual
results could differ materially from those anticipated due to certain risks
inherent in the biotechnology industry and for companies engaged in the
development of new products in a regulated market.
Among other things, the Company's ability to achieve profitability will depend
on the success of the sales efforts for RAPTIVA(R), the Company's ability to
effectively anticipate and manage its expenditures and the availability of
capital market and other financing, and the sales efforts for RAPTIVA(R) may not
be successful if Genentech or its partner, Serono SA, fails to meet its
commercialization goals, due to the strength of the competition, if physicians
do not adopt the product as treatment for their patients or if important
remaining regulatory approvals are not obtained. These and other risks,
including those related to the results of pre-clinical testing, the timing or
results of pending and future clinical trials (including the design and progress
of clinical trials; safety and efficacy of the products being tested; action,
inaction or delay by the FDA, European or other regulators or their advisory
bodies;
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and analysis or interpretation by, or submission to, these entities or others of
scientific data), changes in the status of the existing collaborative
relationships, the ability of collaborators and other partners to meet their
obligations, market demand for products, scale up and marketing capabilities,
competition, international operations, share price volatility, availability of
additional licensing or collaboration opportunities, uncertainties regarding the
status of biotechnology patents, uncertainties as to the cost of protecting
intellectual property and risks associated with XOMA's status as a Bermuda
company, are described in more detail in the Company's most recent annual report
on Form 10-K and in other SEC filings.
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