IRVINE, Calif., March 20 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI) today reported financial results for the fourth quarter and full year ended December 31, 2007. Financial information presented represents the consolidated results of IDM Pharma, Inc. and its subsidiary, IDM Pharma S.A.
Total revenues in the quarter ended December 31, 2007 were $5.6
million, and net loss was $2.7 million or $0.11 per share for the quarter.
Total revenues for the year ended December 31, 2007 were $14.6 million, and
net loss was $18.3 million or $0.87 per share for the year. Revenues in
both the quarter and year ended December 31, 2007 included $2.4 million of
deferred revenue recognized by the Company as a result of the decision by
sanofi-aventis to terminate its participation in the UVIDEM development
program in December 2007. Cash and cash equivalents was $28.4 million as of
December 31, 2007 compared to $33.2 million on September 30, 2007 and $10.2
million on December 31, 2006. We believe that our existing cash resources
are sufficient to meet our cash requirements, based on our current
development and operating plan, into the first half of 2009.
-- The European Committee for Medicinal Products for Human Use, or CHMP,
determined in a non-binding opinion in late January 2008 that
L-MTP-PE suggested a possible clinical benefit in terms of survival
and granted the Company a clock stop, or time extension.
-- The Company expects to receive a final opinion regarding L-MTP-PE from
the CHMP in the third quarter of 2008 and a final decision from the
European Commission in the fourth quarter of 2008.
-- The Company expects to file an amendment to the L-MTP-PE new drug
application, or NDA, to the FDA in the fourth quarter of 2008.
-- Updated Phase 3 data on L-MTP-PE was presented at the Connective
Tissue Oncology Society, or CTOS, meeting in November 2007. Also,
data from our L-MTP-PE compassionate use program was presented at the
November 2007 meeting of the International Society of Pediatric
Oncology, or SIOP.
-- Announced Phase 3 Mifamurtide (L-MTP-PE) study demonstrating improved
survival was published in the Journal of Clinical Oncology in February
2008. Children's Oncology Group report shows the addition of L-MTP-PE
to chemotherapy reduced the risk of death by 30% in osteosarcoma
-- In June 2007, we completed a registered direct offering of our common
stock, and warrants to purchase common stock, and received
approximately $25.0 million in gross proceeds, and finished 2007 with
$28.4 million, providing cash for operations into the first half of
"We made significant progress over the past year in our efforts to bring our lead product candidate, L-MTP-PE, to market in Europe," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "We are developing L-MTP-PE for the treatment of osteosarcoma, the most common type of bone cancer affecting adolescents. We believe our updated survival data from the L-MTP-PE Phase 3 trial, demonstrating statistically superior overall survival in long-term patient follow-up, were critical to the recent non-binding opinion of the Committee for Medicinal Products for Human Use in Europe that L-MTP-PE suggested a possible clinical benefit in terms of survival. We remain committed to resolving the remaining items of the L-MTP-PE European Marketing Authorization Application and working at the same time to advance this important potential treatment through its U.S. regulatory path."
Details of Financial Results
Total revenues in the quarter ended December 31, 2007 were $5.6 million compared to total revenues of $3.0 million for the quarter ended December 31, 2006. Total revenues were $14.6 million for the year ended December 31, 2007, compared to total revenues of $11.3 million for the year ended December 31, 2006. Revenues in all periods were primarily in connection with the Company's collaboration agreement with sanofi-aventis.
Research and development (R&D) expenses in the quarter ended December 31, 2007 decreased to $4.8 million from $5.3 million in the prior year period. For the year ended December 31, 2007, R&D expenses decreased to $21.8 million for the year ended December 31, 2007 from $22.3 million in 2006. Increased R&D spending during the periods related to L-MTP-PE and UVIDEM development was offset by reductions in development activities related to IDM-2101 and other development candidates that the Company has put on hold, as well as reductions associated with lower headcount and termination of a lease agreement for certain of the Company's Paris facilities.
Selling and marketing and general and administrative (SG&A) expenses were $2.9 million for the quarter ended December 31, 2007 compared with $2.8 million in the prior year period. SG&A expenses increased to $12.6 million for the year ended December 31, 2007 from $10.0 million for the year ended December 31, 2006. The higher expenses in 2007 include $0.5 million in fees paid to an investment advisor in connection with the private placement completed in February 2007, $1.1 million associated with accrued severance benefits, $0.5 million in bonus accruals, and $0.4 million due to higher headcounts and consultant costs in the sales and marketing area.
Restructuring expenses were $1.1 million for both the quarter and year ended December 31, 2007, which included $0.5 million of severance benefits and $0.6 million of fixed asset impairments related to the decision to close the Company's operations in France following notification of sanofi-aventis' decision in December 2007 to terminate its participation in the UVIDEM development program.
Interest income increased to $0.4 million for the three months ended December 31, 2007 from $0.1 million in the prior year period. Interest income increased to $1.1 million for the year ended December 31, 2007 from $0.5 million in 2006. These increases in interest income were the result of higher investment cash balances.
Interest expense for the quarter ended December 31, 2007 was a negative expense of $1.1 million compared with no interest expense in the prior year period. Interest expense for the year ended December 31, 2007 was a negative expense of $3.9 million compared to no interest expense for the year ended December 31, 2006. The negative expense in both the quarter and year ended December 31, 2007 was to record the net decrease in the fair value of warrants issued in February and June 2007.
The foreign exchange loss, which results from changes in the value of the dollar versus the Euro on the dollar denominated inter-company loan between the Company's subsidiaries, was $0.4 million in the fourth quarter of 2007, compared to $0.9 million in the prior year period. This foreign exchange loss was $1.7 million in the year ended December 31, 2007, compared to $2.6 million in 2006.
Net loss for the fourth quarter of 2007 was $2.7 million, or $0.11 per basic and diluted share, compared to a net loss of $5.9 million, or $0.44 per share in the corresponding period in 2006. Net loss for the year ended December 31, 2007 was $18.3 million, or $0.87 per basic and diluted loss per share compared to a net loss of $23.5 million, or $1.75 per share in the year ended December 31, 2006.
Update on L-MTP-PE Regulatory Status
The Company recently announced that following presentation of data at an oral explanation hearing before the Committee for Medicinal Products for Human Use (CHMP), the CHMP determined in a non-binding opinion that L-MTP-PE suggested a possible clinical benefit in terms of survival and granted the Company a clock stop, or time extension. The clock stop will allow the Company additional time to respond to all the remaining questions regarding the marketing authorization application for L-MTP-PE (MAA). The CHMP has requested clarification of the existing data in order to gain assurance about the quality of the data before drawing any final conclusions from the data presented. In addition, the Company is required to address a number of remaining questions relating to chemistry, manufacturing and controls (CMC). The Company expects to receive a final opinion from the CHMP in the third quarter and a final decision from the European Commission in the fourth quarter of 2008.
As previously announced, in the United States the Company continues to work with the Children's Oncology Group as well as external experts and advisors to gather patient follow up data from the Phase 3 clinical trial of L-MTP-PE and to respond to other questions in the non-approvable letter the Company received from the U.S. Food and Drug Administration (FDA). The Company expects to submit the amended new drug application (NDA) in the fourth quarter of 2008.
L-MTP-PE was granted orphan drug status in the United States in 2001 and in Europe in 2004. In Europe, the MAA was filed in November 2006 and in the U.S., the NDA was submitted to FDA in October 2006 and was accepted for review in December 2006.
As previously announced, the Company is evaluating the Company's research and development programs, including related assets and costs, and strategic alternatives available to the Company.
About IDM Pharma
IDM Pharma is focused on the development of innovative cancer products that either destroy cancer cells by activating the immune system or prevent tumor recurrence by triggering a specific adaptive immune response. IDM Pharma is dedicated to maximizing the full therapeutic and commercial potential of each of its innovative products to address the needs of patients and the physicians who treat these patients.
For more information about the company and its products, visit http://www.idm-pharma.com.
This press release includes forward-looking statements that reflect
management's current views of future events including statements regarding
the timeframe in which the Company's cash will be sufficient to meet
planned operations, the Company's plans to address the remaining questions
with respect to the MAA during the clock-stop granted by the CHMP, and the
expected timing of a final opinion from the CHMP and of a final regulatory
decision regarding the MAA in the European Union, as well as the Company's
plans to collect, analyze and submit additional Phase 3 data in an amended
NDA for L-MTP-PE, including the expected timing for such amended NDA, and
to respond to other matters raised by the FDA and plans to evaluate
strategic alternatives. Actual results may differ materially from the
forward-looking statements due to a number of important factors, including,
but not limited to, whether the Company will be able to provide assurance
regarding the quality of the existing data and to respond to the remaining
issues with regard to the MAA, including verification of data quality and
CMC items, to the satisfaction of the CHMP, whether the final opinion of
the CHMP will be consistent with the non-binding opinion of the CHMP,
whether the European Commission will follow the final opinion of the CHMP
once issued, whether the timing for the final opinion of the CHMP and the
regulatory decision in Europe will occur as expected by the Company, the
possibility that additional data from the Phase 3 clinical trial of
L-MTP-PE and other information in any amendment to the NDA for L-MTP-PE
submitted by the Company may not provide adequate support for regulatory
approval of L-MTP-PE in the United States within the timeframe expected by
the Company, if at all, whether the Company will be able to manufacture and
commercialize L-MTP-PE even if it is approved by regulatory authorities,
and whether the cash resources of the Company will be sufficient to fund
operations as planned. These and other risks affecting the Company and its
drug development programs, intellectual property rights, personnel and
business are more fully discussed in the Company's Quarterly Report on Form
10-Q filed with the SEC for the quarter ended September 30, 2007 and other
periodic reports filed with the SEC. The Company expressly disclaims any
intent or obligation to update these forward-looking statements, except as
required by law.
IDM PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Quarter Ended December 31, Ended December 31,
2007 2006 2007 2006
revenue $5,252,000 $2,919,000 $14,246,000 $11,147,000
Research grants and
contract revenue - 28,000 55,000 96,000
other revenues 299,000 11,000 329,000 43,000
Total revenues 5,551,000 2,958,000 14,630,000 11,286,000
Costs and expenses:
development 4,796,000 5,297,000 21,828,000 22,329,000
licenses 416,000 95,000 511,000 592,000
marketing 576,000 208,000 1,024,000 605,000
administrative 2,319,000 2,585,000 11,535,000 9,402,000
Restructuring 1,092,000 - 1,092,000 -
Total costs and
expenses 9,199,000 8,185,000 35,990,000 32,928,000
operations (3,648,000) (5,227,000) (21,360,000) (21,642,000)
Interest income 360,000 76,000 1,118,000 503,000
Interest expense 1,053,000 - 3,878,000 -
Other income, net 23,000 - - -
loss (381,000) (861,000) (1,680,000) (2,559,000)
Loss before income
tax (2,593,000) (6,012,000) (18,044,000) (23,698,000)
Income tax (expense)
benefit (89,000) 64,000 (306,000) 243,000
Net loss $(2,682,000) $(5,948,000) $(18,350,000) $(23,455,000)
number of shares
outstanding 25,148,380 13,401,071 21,075,738 13,366,002
Basic and diluted
loss per share $(0.11) $(0.44) $(0.87) $(1.75)
Net loss $(2,682,000) $(5,948,000) $(18,350,000) $(23,455,000)
gain 403,000 1,157,000 2,041,000 3,545,000
$(2,279,000) $(4,791,000) $(16,309,000) $(19,910,000)
IDM PHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, December 31,
Cash and cash equivalents $28,382,000 $10,181,000
Other current assets 4,786,000 4,973,000
Total current assets 33,168,000 15,154,000
Property and equipment, net 513,000 1,711,000
Patents, trademarks and other licenses, net 2,734,000 3,323,000
Goodwill 2,812,000 2,812,000
Other long-term assets 832,000 1,382,000
Total Assets $40,059,000 $24,382,000
LIABILITIES AND STOCKHOLDERS' EQUITY
Common stock warrants $450,000 $-
Other current liabilities 11,712,000 10,636,000
Other liabilities 1,874,000 3,550,000
Stockholders' equity 26,023,000 10,196,000
Total liabilities and stockholders'
equity $40,059,000 $24,382,000
|SOURCE IDM Pharma, Inc.|
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