XOMA Reports 2011 and Fourth Quarter Financial Results
"While the first half of 2011 included some disappointments, we had a crucial success in attracting a world-class pharmaceutical company,
"As you have seen from us in the early months of 2012, we remain focused on investing in value-creating activities. We believe
For the fourth quarter ended
2012 Organizational Changes to Focus on Value-Creating Activities and Fourth Quarter 2011 Operational Highlights
January 5, 2012, XOMAannounced the appointment of John Varianas Chief Executive Officer, in addition to his continued position as a member of the Board of Directors. Concurrently, Mr. Varianannounced the streamlining of XOMA'soperations to focus on value-creating activities, primarily the expansion of gevokizumab's clinical development program. The streamlining resulted in
- a personnel reduction of 84 positions
- the decision to outsource Phase 3 and commercial-scale manufacturing
- the elimination of internal research functions that were non-differentiated or obtainable cost-effectively through contract service providers
- a reduction in G&A spending of 20% to support the leaner organization
- the decision to complete the biodefense contracts
XOMAhas in place but not actively pursue future contracts.
November 2011, the Company announced the expansion of XOMA'sPhase 3 program for gevokizumab to the broader indication of non-infectious uveitis (NIU). NIU is a broad-spectrum ocular disorder, which includes Behcet's uveitis, affecting an estimated 150,000 people in the United States. The Company expects to begin its global Phase 3 program in the second quarter of 2012.
December 2011, XOMAlaunched a Phase 2 proof-of-concept trial to determine gevokizumab's efficacy in treating moderate to severe inflammatory acne. This study is the first in a series of three proof-of-concept Phase 2 studies that XOMAis conducting to expand the value of gevokizumab.
December 2011, the Company secured a $10 millionterm loan from GE Capital.
October 2011, the Company was awarded a new U.S. government contract for up to $28 millionover five years to develop broad-spectrum antitoxins for the treatment of human botulism poisoning.
December 2011, XOMAchanged its jurisdiction of incorporation from Bermudato Delaware.
The Company reaffirmed the anticipated cash used in ongoing operating activities during 2012 to be approximately
Investor Conference Call and Webcast
About Non-infectious Uveitis
The term uveitis broadly refers to the inflammatory diseases that affect the portion of the eye known as the uvea, which is the middle of three layers that surround the eye. People with uveitis may experience decreased vision, pain, light sensitivity, and floaters. Uveitis may be caused by an infection that is commonly treated with an antimicrobial agent, or by an unknown pathogen triggering inflammation, called non-infectious uveitis.
The most common form of uveitis affects the front of the eye and is known as anterior uveitis. Other forms include intermediate uveitis, posterior uveitis, and pan uveitis. These types differ in that they all include involvement of the back portions of the eye. Posterior uveitis refers to inflammation in the retina and the choroid, and it may result from a different immune response trigger. Pan-uveitis refers to inflammation of all three major parts of the eye. Behcet's uveitis is a well-known form of pan-uveitis. Due to the swelling of tissues critical to vision, intermediate, posterior, and pan-uveitis (which collectively make up NIU) can lead to blindness if not treated.
In order to retain the value of
Through its unique discovery platform, the Company is focused on discovering and developing allosteric modulating antibodies that combine the beneficial pharmacology of small molecule drugs with the target specificity of antibodies. Among these novel discoveries are two new classes of fully human antibodies: XMetA partially activates the insulin receptor, and XMetS sensitizes the insulin receptor. These two programs represent distinct and potentially breakthrough therapeutic approaches to the treatment of patients with diabetes. XOMA is headquartered in
Certain statements contained herein concerning timing of initiation of clinical trials, availability of clinical trial results, continued sales of approved products, regulatory approval of unapproved product candidates and anticipated levels of cash utilization, 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 timing of initiation of and availability of results of clinical trials may be delayed or may never occur as a result of actions or inaction by regulators or present or future collaboration partners, complications in the design, implementation or third-party approval of clinical trials, complications in the collection or interpretation of statistical data or unanticipated safety issues; continued sales of approved products may be impacted by
These and other risks, including those related to current economic and financial market conditions; the results of discovery and 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
** Tables Follow **
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
Three months ended
|License and collaborative fees||$ 1,266||$ 433||$ 17,991||$ 2,182|
|Contract and other revenue||8,560||9,150||40,037||27,174|
|Research and development||16,659||19,134||68,137||77,413|
|Selling, general and administrative||5,235||6,557||24,014||23,332|
|Total operating expenses||21,894||25,691||92,151||100,745|
|Loss from operations||(12,047)||(16,090)||(33,955)||(67,104)|
|Other income (expense):|
|Other income (expense):||956||(1,554)||3,689||(1,240)|
|Net loss before taxes||(11,735)||(17,748)||(32,728)||(68,729)|
|Provision for income tax expense||--||(10)||(15)||(27)|
|Net loss||$ (11,735)||$ (17,758)||$ (32,743)||$ (68,756)|
|Basic and diluted net loss per share of common stock||$ (0.34)||$ (0.84)||$ (1.04)||$ (3.69)|
Shares used in computing basic and diluted net loss per
share of common stock
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$ 48,344||$ 37,304|
|Trade and other receivables, net||12,332||20,864|
|Prepaid expenses and other current assets||2,019||712|
|Total current assets||62,695||58,880|
|Property and equipment, net||12,709||14,869|
|Total assets||$ 78,036||$ 74,252|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable||$ 2,128||$ 3,581|
|Accrued and other liabilities||10,012||10,658|
|Interest bearing obligations - current||2,796||--|
|Total current liabilities||21,010||35,528|
|Deferred revenue — long-term||7,539||1,086|
|Interest bearing obligations — long-term||33,524||13,694|
|Other liabilities - long term||952||353|
|Total liabilities and stockholders' equity||$ 78,036||$ 74,252|
XOMA Ltd.Company and Investor Contact: Carol DeGuzman510-204-7270 firstname.lastname@example.org Juliane Snowden The Oratorium Group, LLCjsnowden@oratoriumgroup.com Media Contact: Canale Communications Pam Lord619-849-6003 email@example.com
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