XOMA Reports 2012 Operational Highlights and Fourth Quarter and Full-Year Financial Results
2012 Operational Highlights
- Initiated a global Phase 3 gevokizumab clinical trial program, termed EYEGUARD™, in non-infectious intermediate, posterior or pan-uveitis ("NIU"):
- EYEGUARD-A in patients with active NIU, sponsored by
- EYEGUARD-C in patients with controlled NIU also sponsored by
- EYEGUARD-B in patients with Behçet's uveitis sponsored by
XOMA'sdevelopment and commercialization partner Les Laboratories Servier ("Servier")
Advanced the Phase 2 proof-of-concept ("POC") program to identify the next Phase 3 indication for gevokizumab. Two of the three studies in the POC program, the moderate-to-severe acne study and the erosive arthritis of the hand study ("EOA"), enrolled patients during 2012. The third indication, non-infectious anterior scleritis, was selected, and
XOMAis working with the National Eye Institute("NEI"), one of the National Institutes of Health, to finalize the study protocol.
Received Orphan Drug Designation from the
U.S. Food and Drug Administration("FDA") for gevokizumab in the NIU indication.
Entered into a technology and process transfer agreement with Boehringer Ingelheim and
Servierfor the commercial manufacture of gevokizumab.
John Varianhad accepted the position of Chief Executive Officer and Paul Rubin, M.D., had been promoted to Senior Vice President, Research and Development, and Chief Medical Officer.
$79.2 millionin two public equity offerings.
$17.0 millionreduction in internal expense reflecting streamlined operations to focus exclusively on value-creating activities.
"2012 was focused on identifying ways to create and capture value from gevokizumab," stated
"2013 will find the
For the year ended
The company announced its anticipated cash used in ongoing operating activities during 2013 will be approximately
Investor Conference Call and Webcast
Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine that has been shown to be involved in non-infectious uveitis, including Behçet's uveitis, cardiovascular disease, and other auto-inflammatory diseases. By binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation. Gevokizumab has been studied in over 500 patients, with approximately 300 patients on treatment for six months, and has been shown to be well-tolerated. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov.
More detailed information can be found at www.xoma.com.
The XOMA Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5960
More information is available at: www.servier.com.
Certain statements contained in this press release including, but not limited to, statements related to anticipated timing of initiation and completion of clinical trials, proof-of-concept trials, anticipated size of clinical trials, continued sales of approved products, regulatory approval of unapproved product candidates, anticipated restructuring charges, sufficiency of our cash resources 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, and 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. Potential risks to
|CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|(in thousands, except per share amounts)|
Three months ended
|License and collaborative fees||$ 1,062||$ 1,266||$ 5,727||$ 17,991|
|Contract and other||6,043||8,560||26,852||40,037|
|Net product sales||249||--||1,044||--|
|Research and development||15,732||16,659||68,324||68,137|
|Selling, general and administrative||3,947||5,235||16,865||24,014|
|Cost of sales||33||--||143||--|
|Total operating expenses||20,011||21,894||90,406||92,151|
|Loss from operations||(12,619)||(12,047)||(56,624)||(33,955)|
|Other income (expense):|
|Other (expense) income||(414)||439||(956)||(177)|
|Revaluation of contingent warrant liabilities||16,574||517||(9,172)||3,866|
|Net loss before taxes||2,365||(11,735)||(71,139)||(32,728)|
|Provision for income tax benefit (expense)||--||--||74||(15)|
|Net loss||$ 2,365||$ (11,735)||$ (71,065)||$ (32,743)|
|Basic and diluted net income (loss) per share of common stock||$ 0.03||$ (0.34)||$ (1.10)||$ (1.04)|
|Shares used in computing basic net income (loss) per share of common stock||77,703||34,420||64,629||31,590|
|Shares used in computing diluted net income (loss) per share of common stock||93,862||34,420||64,629||31,590|
|Net unrealized gains on available-for-sale securities||1||--||8||--|
|Comprehensive loss||$ 2,366||$ (11,735)||$ (71,057)||$ (32,743)|
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share amounts)|
|Cash and cash equivalents||$ 45,345||$ 48,344|
|Trade and other receivables, net||8,249||12,332|
|Prepaid expenses and other current assets||2,256||2,019|
|Total current assets||95,837||62,695|
|Property and equipment, net||8,143||12,709|
|Total assets||$ 105,676||$ 78,036|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable||$ 3,867||$ 2,128|
|Accrued and other liabilities||13,166||10,012|
|Interest bearing obligation — current||3,391||2,796|
|Total current liabilities||23,833||20,631|
|Deferred revenue — long-term||6,315||7,539|
|Interest bearing obligations — long-term||37,653||33,524|
|Contingent warrant liabilities||15,001||379|
|Other liabilities - long-term||1,407||952|
|Additional paid-in capital||977,962||900,801|
|Accumulated comprehensive income||8||--|
|Total stockholders' equity||21,467||15,011|
|Total liabilities and stockholders' equity||$ 105,676||$ 78,036|
XOMA Corporation Companyand Investor Contact: Ashleigh Barreto510-204-7482 firstname.lastname@example.org Juliane Snowden The Oratorium Group, LLCjsnowden@oratoriumgroup.com Media Contact: Canale Communications Carolyn Hawley619-849-5375 email@example.com
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