Antigenics Reports Fourth Quarter and Year-End 2008 Financial Results
Listen to a webcast of this event
NEW YORK February 19, 2009 Antigenics Inc. (NASDAQ: AGEN) reported results
today for the three months and year ended December 31, 2008. For the three months ended
December 31, 2008, the company reported net income attributable to common stockholders of
$5.1 million, or $0.08 per share, basic and diluted, compared with a net loss attributable to
common stockholders of $7.7 million, or $0.16 per share, basic and diluted, for the same period
in 2007. For the year ended December 31, 2008, Antigenics incurred a net loss attributable to
common stockholders of $29.5 million, or $0.47 per share, basic and diluted, compared with a
net loss attributable to common stockholders of $37.6 million, or $0.81 per share, basic and
diluted, for the year ended December 31, 2007.
During the quarter ended December 31, 2008, the company paid $2.9 million to repurchase $11.8
million of its convertible notes, resulting in a gain of $8.6 million. This will reduce annual
interest expense by $0.6 million. In addition, the company sold certain patent technology
resulting in a gain of $4.6 million. Cash, cash equivalents and short-term investments amounted
to $34.5 million as of December 31, 2008.
The company's net cash burn (cash used in operating activities plus capital expenditures, debt
repayments and dividend payments) for the year ended December 31, 2008 was $32.8 million,
which represented an increase from the net cash burn of $27.5 million for the year ended
December 31, 2007. The increase in cash burn is primarily due to registration and
commercialization efforts for Oncophage in Russia and the European Union coupled with
reduced QS-21 revenues.
Corporate Update
Oncophage® (vitespen)
-
In November 2008, final results from a Phase 1 investigator-sponsored trial of
Oncophage® (vitespen) in recurrent, high-grade glioma were presented at the Society for
Neuro-Oncology.s 13th Annual Scientific Meeting. All patients enrolled in the trial had
at least one recurrence of brain cancer prior to enrollment and more than half of the
patients had more than one recurrence. The Oncophage vaccination following brain
tumor resection resulted in overall median survival of approximately 10.5 months, with
four patients surviving up to and beyond 12 months with one patient surviving almost 2.5
years. This is compared to a historical median survival of only 6.5 months post surgery.
A tumor-specific response was detected after vaccination in all 12 patients.
-
The study also observed a correlation between immune response and overall survival as a
result of treatment with Oncophage (n=12; P < .001). The responses were validated by
using three separate immune techniques and showed that Oncophage evoked a tumorspecific
immune response by producing activated T-cells and natural killer cells that can
potentially destroy tumor cells.
-
The Phase 2 portion of the investigator-sponsored study of Oncophage in glioma
continues to enroll patients. This study is being supported by the NIH.s Brain Tumor
Specialized Programs of Research Excellence (SPORE) program.
-
The European Medicines Agency continues to review the marketing application for
Oncophage as an adjuvant treatment in early-stage renal cell carcinoma (RCC; the most
common type of kidney cancer).
-
The company continues to make progress toward the commercial launch of Oncophage in
Russia. The current key focus of activities in Russia pertains to obtaining government
reimbursement for Oncophage in 2009.
QS-21 Stimulon® Adjuvant
-
The company's licensees, including GlaxoSmithKline (GSK) and Elan, continue to
advance clinical development of over 15 vaccines that contain the company's QS-21
vaccine adjuvant.
-
In December 2008, GSK published two studies in The New England Journal of Medicine
detailing results from its Phase 2 clinical trials testing their QS-21-containing malaria
vaccine candidate in African infants and young children. The data reaffirms earlier study
results and support the ongoing efforts, pending regulatory approvals, to launch a
potentially pivotal Phase 3 study with the QS-21-containing adjuvant system in 2009.
-
GSK recently presented Phase 1 data in healthy volunteers (n=180) of a candidate HIV
vaccine formulated with or without a QS-21-containing adjuvant system. The highest
frequencies of HIV antigen-specific CD4+ T cells and responder rates were observed in
the adjuvanted vaccine formulations. Furthermore, the vaccine showed an acceptable
safety and reactogenicity profile and no vaccine related serious adverse events were
reported.
Corporate
-
In February 2009, Antigenics initiated a restructuring to reduce operating expenses in
light of current market conditions and to focus its resources on near-term commercial
opportunities. The restructuring resulted in a workforce reduction of approximately 20%.
The company has taken other measures to reduce its 2009 cash burn, including the
elimination of cash bonuses and its 401(k) match program. In addition, Antigenics'
chairman and CEO elected to receive 30% of his base salary in stock.
-
As part of Antigenics. restructuring plan and decision to focus on near-term commercial
opportunities, it has put on hold its Aroplatin. and AG-707 development programs. The
company will focus its current activities on the commercialization of Oncophage in
Russia and Europe and sustaining its cash resources until the maturity of the pipeline of
vaccines containing QS-21. The earlier-stage development program of Oncophage in
glioma will continue and will be supported financially from outside organizations.
Antigenics executives will host a conference call at 11:00 a.m. Eastern Time today. To access
the live call, dial 877.762.5772 (domestic) or 706.643.6986 (international); the access code is
85080217. The call will also be webcast and will be accessible from the company's website at
www.antigenics.com/webcast/. A replay will be available approximately two hours after the call
through midnight Eastern Time on March 5, 2009. The replay number is 800.642.1687
(domestic) or 706.645.9291 (international), and the access code is 85080217. The replay will
also be available on the company's website approximately two hours after the live call.
About Antigenics
Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for
cancers and infectious diseases. The company’s investigational product portfolio includes
Oncophage® (vitespen), a patient-specific therapeutic cancer vaccine being evaluated in several
indications; and QS-21 Stimulon®, an adjuvant being evaluated by Antigenics’ collaborative
partners in approximately 15 clinical stage vaccines. For more information, please visit www.antigenics.com.
This earnings release contains forward-looking statements, including statements regarding the
development programs and clinical trial activities, funding, and timelines of Antigenics and its
licensees and partners, the potential effects of the company.s recent restructuring efforts,
anticipated interest income expense reductions and other cost containment measures, and
commercialization efforts and potential reimbursement timelines for Oncophage in Russia and
other territories. These forward-looking statements are subject to risks and uncertainties that
could cause actual results to differ materially. These risks and uncertainties include, among
others, decisions by our licensees and partners, regulatory authorities, physicians and patients;
the possibility that results from future treatments with Oncophage or studies with our other
product candidates will not be as favorable as prior results; the inability to secure local
distributors and payment mechanisms in Russia or any other jurisdiction in which Antigenics
may obtain product approval; the ability to sustain cash resources and finance future
development of Oncophage; the potential that we may not be able to maintain our listing on the
NASDAQ Global Market or meet the requirements of the NASDAQ Capital Market; and the
factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission for the period ended September 30, 2008.
Antigenics cautions investors not to place considerable reliance on the forward-looking
statements contained in this release. These statements speak only as of the date of this document,
and Antigenics undertakes no obligation to update or revise the statements. All forward-looking
statements are expressly qualified in their entirety by this cautionary statement. Antigenics'
business is subject to substantial risks and uncertainties, including those identified above. When
evaluating Antigenics' business and securities, investors should give careful consideration to
these risks and uncertainties.
Summary Consolidated Financial Information
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data) (unaudited)
| |
Three months ended December 31, |
|
Year ended December 31, |
| |
2008 |
|
2007 |
|
2008 |
|
2007 |
| |
|
|
|
|
|
|
|
| Revenue |
$521 |
|
$ 893 |
|
$ 2,651 |
|
$ 5,552 |
| |
|
|
|
|
|
|
|
| Operating expenses: |
|
|
|
|
|
|
|
| Research and development |
3,698 |
|
3,643 |
|
20,663 |
|
21,789 |
| General and administrative |
3,690 |
|
3,730 |
|
19,832 |
|
17,041 |
| |
|
|
|
|
|
|
|
| Operating loss |
(6,867) |
|
(6,480) |
|
(37,844) |
|
(33,278) |
| |
|
|
|
|
|
|
|
| Other income (expense), net |
12,125 |
|
(980) |
|
9,146 |
|
(3,517) |
| |
|
|
|
|
|
|
|
| Net loss |
5,258 |
|
(7,460) |
|
(28,698) |
|
(36,795) |
| |
|
|
|
|
|
|
|
Dividends on Series A convertible
preferred stock |
(197) |
|
(197) |
|
(790) |
|
(790) |
| |
|
|
|
|
|
|
|
| Net loss attributable to common stockholders |
$ 5,061 |
|
$ (7,657) |
|
$ (29,488) |
|
$ (37,585) |
| |
|
|
|
|
|
|
|
| Per common share data, basic: |
|
|
|
|
|
|
|
| Net income (loss) attributable to common stockholders |
$ 0.08 |
|
$ (0.16) |
|
$ (0.47) |
|
$ (0.81) |
Weighted average number of common
shares outstanding, diluted |
66,391 |
|
47,655 |
|
63,249 |
|
46,512 |
| Per common share data, basic: |
|
|
|
|
|
|
|
| Net income (loss) attributable to common stockholders |
$ 0.08 |
|
$ (0.16) |
|
$ (0.47) |
|
$ (0.81) |
Weighted average number of common
shares outstanding, diluted |
75,165 |
|
47,655 |
|
63,249 |
|
46,512 |
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
| |
|
December 31, 2008 |
|
December 31, 2007 |
| Cash, cash equivalents and short-term investments |
|
$ 34,461 |
|
$18,679 |
| Total assets |
|
56,945 |
|
44,537 |
| Total stockholders’ (defecit) |
|
(23,918) |
|
(47,060) |
|