XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, today announced 2013
operational highlights and financial results for the fourth quarter
and year ended December 31, 2013.
2013 Operational Highlights
- Announced the selection of pyoderma gangrenosum (PG) as its
next Phase 3 indication for gevokizumab based upon the compelling
results generated from 6 patients enrolled in the Company's PG
clinical pilot program. In March 2014, the results will be shared
with the FDA to determine the Phase 3 clinical protocol at an End
of Phase 2 meeting. PG is one of a cluster of diseases under the
umbrella of neutrophilic dermatosis.
- Reported Phase 2 data from the Company's gevokizumab study in
patients with moderate to severe inflammatory acne and completed a
thorough analysis of the acne market. Rather than pursuing the
broader acne indication, the Company will consider focusing on less
prevalent but more severe acne indications that also are considered
indications under the neutrophilic dermatosis umbrella.
- Reported promising results in October 2013, from the Day 84
pain and function endpoint in the Company's gevokizumab Phase 2
study in patients with erosive osteoarthritis of the hand (EOA) and
elevated C-reactive protein (CRP). Completed enrollment in a
supplemental study in patients with EOA and non-elevated CRP. On
March 4, 2014, XOMA reported that despite early positive results,
the top-line data at Day 168 in the initial study, as well as at
Day 84 in the supplemental study, were not positive and led to the
Company's decision not to pursue the broad EOA indication for Phase
3 testing. The Company will continue to review the data to
determine if there is a specific segment of the EOA population that
could benefit from gevokizumab therapy.
- Increased the pace of enrollment at 70 U.S. study sites
participating in the gevokizumab EYEGUARD™-A and EYEGUARD-C
studies.
- XOMA's partner, SERVIER, continued to enroll patients in
EYEGUARD-B, which is studying gevokizumab in patients who have
non-infectious uveitis with underlying Behçet's disease, a rare
indication.
- As of yearend, SERVIER had obtained approvals in 15 countries
to conduct the EYEGUARD-A and -C clinical trials. These countries
represent 53 clinical study centers.
- SERVIER initiated enrollment in three of its independent
gevokizumab POC studies: polymyositis/dermatomyositis, Schnitzler's
syndrome, and giant cell arteritis.
- Strengthened the Company's financial position by raising $83.0
million in two public equity offerings, after deducting offering
fees and out of pocket expenses.
- Received $8.6 million in milestone payments from 2
collaborators and licensees.
- Was awarded a patent for XOMA's flexible manufacturing
system.
"In 2013, our Proof-of-Concept program has provided us the
evidence to support what we have known for some time, that
gevokizumab has strong biological activity. In every patient
population we have studied, we see a biological response to our
compound, even if the results are not strong enough to pursue Phase
3 development in large patient populations. We were extremely
excited by the dramatic results we achieved in the first six
patients with pyoderma gangrenosum and have chosen this indication
for pivotal development. We are looking forward to receiving the
FDA's feedback on the data and its requirements for a Phase 3
clinical program in this underserved patient population," stated
John Varian, Chief Executive Officer of XOMA. "We have identified
other indications under the neutrophilic dermatoses classification
that we hope to study in similar pilot studies with the goal of
identifying others that are of value to pursue in Phase 3
development.
"The Proof-of-Concept program was designed to allow gevokizumab
to point us to the right indications to pursue for pivotal
development, while at the same time identifying the indications
that we should not. The program has done that by pointing us to
pyoderma gangrenosum and steering us away from EOA. The decisions
we have made and continue to make are bringing us closer to
realizing our vision of becoming a commercial company, selling
XOMA's products to the U.S. specialist prescriber."
Financial Results
XOMA recorded total revenues of $35.5 million for the twelve
months ended December 31, 2013, compared with $33.8 million during
the same period of 2012. For the three months ended December 31,
2013, XOMA recorded revenues of $12.5 million compared to $7.4
million during the corresponding period of 2012. The increase in
the fourth quarter and full-year 2013 revenues was due primarily to
the receipt of license and collaboration fees, which were offset by
reductions in contract revenue and related expenses from NIAID
government contracts and from reimbursements by Servier for
gevokizumab-related activities.
For the year ended December 31, 2013, XOMA had a net loss of
$124.1 million, or $1.43 per share, compared with a net loss of
$71.1 million, or $1.10 per share, in the year ended December 31,
2012. The full-year net losses in 2013 and 2012 included $61.0
million and $9.2 million, respectively, in non-cash revaluation of
contingent warrant liabilities, which resulted primarily from the
appreciation of XOMA's stock price. Excluding those revaluations,
the net loss for 2013 was $63.0 million, or $0.72 per share, and
the net loss for 2012 was $61.9 million, or $0.96 per share. For
the three months ended December 31, 2013, XOMA reported a net loss
of $52.3 million, or $0.55 per share, of which $35.3 million, or
$0.37 per share, was related directly to the revaluation of
contingent warrant liabilities. For the three months ended December
31, 2012, XOMA had a net income of $2.4 million, or $0.03 per
share, due primarily to a $16.6 million revaluation of contingent
warrant liabilities. Excluding the non-cash revaluation of
contingent warrant liabilities, the net loss for the three months
ended December 31, 2013, was $17.0 million, or $0.18 per share.
Annual research and development (R&D) expenses for 2013 were
$74.9 million compared to $68.5 million in 2012. For the
three-month periods ended December 31, 2013 and 2012, R&D
expenses were $22.9 million and $15.8 million, respectively. The
increases in both of the 2013 periods reflect the increased
external clinical trial costs associated with XOMA's gevokizumab
clinical development programs. Selling, general and administrative
expenses (SG&A) were $18.5 million for the full year of 2013
compared to $16.9 million incurred during 2012, primarily
reflecting consulting expenses during 2013. For the three-month
periods ended December 31, 2013 and 2012, SG&A expenses were
$5.0 million and $3.9 million, respectively.
On December 31, 2013, XOMA had cash, cash equivalents, and
short-term investments of $121.6 million, compared with $85.3
million at December 31, 2012. On December 18, 2013, the Company
announced the closing of the offering of 10,925,000 shares of its
common stock, including 1,425,000 shares of common stock that were
issued upon the exercise in full of the underwriters' option to
purchase additional shares, at a price to the public of $5.25 per
share. XOMA received $53.6 million in net proceeds from the
offering after deducting the underwriting discount and offering
expenses.
2014 Guidance
XOMA announced its anticipated cash used in ongoing operating
activities during 2014 will be approximately $55.0 million to $60.0
million, primarily reflecting the costs associated with conducting
the gevokizumab three Phase 3 clinical trials in the EYEGUARD
program and the costs associated with conducting a Phase 3 clinical
trial in patients with pyoderma gangrenosum.
Investor Conference Call and Webcast
XOMA will host a conference call and webcast today, March 4,
2014, at 6:00 p.m. ET / 3:00 PT. The webcast can be accessed via
the Investors and Media section of XOMA's website at
http://investors.xoma.com/events.cfm and will be available for
replay until close of business on May 4, 2014.
Telephone numbers for the live audiocast are 877-369-6589
(U.S./Canada) and 408-337-0122 (international).
About Gevokizumab
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, and modulates the cellular signaling
events that produce inflammation. IL-1 beta has been shown to be
involved in diverse array of disease states, including
non-infectious uveitis (including Behçet's uveitis), cardiovascular
disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in a global Phase 3
clinical program, termed EYEGUARD™, which is being conducted by
SERVIER and XOMA. This program is designed to determine
gevokizumab's ability to treat acute non-infectious uveitis (NIU)
in EYEGUARD-A, to prevent disease flares in patients with Behçet's
uveitis in EYEGUARD-B, and to prevent disease flares in NIU
patients who are controlled with steroids and immunosuppressants in
EYEGUARD-C.
XOMA has a Proof-of-Concept (POC) program underway in which the
Company is exploring or has explored the efficacy and safety of
gevokizumab in multiple indications: pyoderma gangrenosum, pustular
psoriasis, moderate to severe inflammatory acne, erosive
osteoarthritis of the hand, active non-infectious scleritis,
autoimmune inner ear disease. Separately, SERVIER initiated a Phase
2 study to determine gevokizumab's ability to reduce arterial wall
inflammation in patients with marked atherosclerotic plaque
inflammation and who have experienced an acute coronary syndrome in
the previous twelve months, as well as POC studies in
polymyositis/dermatomyositis, Schnitzler syndrome, and giant cell
arteritis. Information about gevokizumab clinical studies can be
found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu
About XOMA
XOMA has built a portfolio of innovative therapeutic antibodies,
both in late-stage clinical development and in preclinical
research. XOMA focuses its antibody research and development on
allosteric modulation, which offers opportunities for new classes
of therapeutic antibodies to treat a wide range of human diseases.
XOMA's lead product candidate, gevokizumab (IL-1 beta modulating
antibody), is in a global Phase 3 program in non-infectious uveitis
with its partner SERVIER and multiple proof-of-concept studies in
other IL-1-mediated diseases. XOMA's scientific research also
produced the XMet program, which consists of three classes of
preclinical antibodies, including Selective Insulin Receptor
Modulators (SIRMs) that could have a significant effect on the
treatment of diabetes.
More detailed information can be found at www.xoma.com
About Servier
"Since the company's creation, all of our profits are ploughed
back into research," Jacques Servier, Founding President of the
Group.
Founded in 1954, Servier is an independent French pharmaceutical
research company. Its development is based on the continuous
pursuit of innovation in the therapeutic areas of cardiovascular,
metabolic, neurologic, psychiatric, bone and joint diseases, as
well as cancer. With a strong international presence in 140
countries, Servier employs more than 22,000 people worldwide. In
2012, the company recorded revenue of 3.9 billion euros, and 92% of
Servier drugs are consumed internationally. The Servier Group
contributed 57% to the 2012 French trade surplus in the
pharmaceuticals sector. The Company reinvested 25% of its revenues
into R&D in 2012.
More information is available at: www.servier.com
Forward-Looking Statements
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, regulatory approval of
unapproved product candidates, sufficiency of our cash resources
and anticipated levels of cash utilization, or statements 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 XOMA meeting these expectations are
described in more detail in XOMA's most recent filing on Form 10-K
and in other SEC filings. Consider such risks carefully when
considering XOMA's prospects. Any forward-looking statement in
this press release represents XOMA's views only as of the date of
this press release and should not be relied upon as representing
its views as of any subsequent date. XOMA disclaims any obligation
to update any forward-looking statement, except as required by
applicable law.
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XOMA
Corporation |
CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS |
(in thousands, except
per share amounts) |
|
|
|
|
|
|
Three months
ended December 31, |
Year ended
December 31, |
|
2013 |
2012 |
2013 |
2012 |
Revenues: |
|
|
|
|
License and collaborative
fees |
$ 8,450 |
$ 1,062 |
$ 11,028 |
$ 5,727 |
Contract and other |
4,084 |
6,330 |
24,423 |
28,055 |
Total revenues |
12,534 |
7,392 |
35,451 |
33,782 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and
development |
22,946 |
15,765 |
74,851 |
68,467 |
Selling, general and
administrative |
5,049 |
3,947 |
18,477 |
16,865 |
Restructuring |
119 |
299 |
328 |
5,074 |
Total operating expenses |
28,114 |
20,011 |
93,656 |
90,406 |
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|
|
|
|
Loss from operations |
(15,580) |
(12,619) |
(58,205) |
(56,624) |
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|
|
Other (expense) income: |
|
|
|
|
Interest expense |
(1,137) |
(1,176) |
(4,631) |
(4,387) |
Other expense |
(287) |
(414) |
(197) |
(956) |
Revaluation of contingent
warrant liabilities |
(35,294) |
16,574 |
(61,039) |
(9,172) |
Net (loss) income before
taxes |
(52,298) |
2,365 |
(124,072) |
(71,139) |
|
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|
|
Provision for income tax (expense)
benefit |
(1) |
-- |
14 |
74 |
|
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|
|
|
Net (loss) income |
$ (52,299) |
$ 2,365 |
$ (124,058) |
$ (71,065) |
|
|
|
|
|
Basic and diluted net (loss) income per share
of common stock |
$ (0.55) |
$ 0.03 |
$ (1.43) |
$ (1.10) |
|
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|
|
Shares used in computing basic net (loss)
income per share of common stock |
95,048 |
77,703 |
86,938 |
64,629 |
Shares used in computing diluted net (loss)
income per share of common stock |
95,048 |
93,862 |
86,938 |
64,629 |
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Other comprehensive (loss) income: |
|
|
|
|
Net (loss) income |
(52,299) |
2,365 |
(124,058) |
$ (71,065) |
Net unrealized (loss)
gain on available-for-sale securities |
(1) |
1 |
(9) |
8 |
Comprehensive (loss)
income |
$ (52,300) |
$ 2,366 |
$ (124,067) |
$ (71,057) |
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XOMA
Corporation |
CONSOLIDATED BALANCE
SHEETS |
(in thousands, except
share and per share amounts) |
|
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December
31, |
|
2013 |
2012 |
ASSETS |
Current assets: |
|
|
Cash and cash equivalents |
$ 101,659 |
$ 45,345 |
Short-term investments |
19,990 |
39,987 |
Trade and other receivables,
net |
3,781 |
8,249 |
Prepaid expenses and other
current assets |
1,630 |
2,256 |
Total current assets |
127,060 |
95,837 |
Property and equipment, net |
6,456 |
8,143 |
Other assets |
1,266 |
1,696 |
Total assets |
$ 134,782 |
$ 105,676 |
|
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|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY |
|
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Current liabilities: |
|
|
Accounts payable |
$ 9,616 |
$ 3,867 |
Accrued and other
liabilities |
9,934 |
13,045 |
Deferred revenue |
2,218 |
3,409 |
Interest bearing obligation –
current |
5,835 |
3,391 |
Accrued interest on
interest bearing obligation – current |
2,042 |
121 |
Total current liabilities |
29,645 |
23,833 |
Deferred revenue – long-term |
4,105 |
6,315 |
Interest bearing obligations – long-term |
35,150 |
37,653 |
Contingent warrant liabilities |
69,869 |
15,001 |
Other liabilities - long-term |
-- |
1,407 |
Total liabilities |
138,769 |
84,209 |
|
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Stockholders' (deficit) equity: |
|
|
Common stock, $0.0075 par
value, 138,666,666 shares authorized, 105,386,216 and 82,447,274
shares outstanding at December 31, 2013 and 2012, respectively |
787 |
615 |
Additional paid-in capital |
1,076,403 |
977,962 |
Accumulated comprehensive
(loss) income |
(1) |
8 |
Accumulated deficit |
(1,081,176) |
(957,118) |
Total stockholders' (deficit)
equity |
(3,987) |
21,467 |
Total liabilities and
stockholders' (deficit) equity |
$ 134,782 |
$ 105,676 |
CONTACT: Company and Investor Contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Canale Communications
Carolyn Hawley
619-849-5375
Carolyn@canalecomm.com
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