13.08.2008 05:35:00
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GPC Biotech Reports Financial Results for Second Quarter and First Six Months of 2008
GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today
reported financial results for the second quarter and first six months
ended June 30, 2008.
First six months of 2008 compared to first six months of 2007
Revenues decreased 57% to € 3.1 million for
the six months ended June 30, 2008, compared to €
7.2 million for the same period in 2007. The decrease in revenues is due
to decreased payments from Celgene Corporation relating to the
co-development and license agreement for satraplatin. Research and
development (R&D) expenses decreased 62% to €
10.3 million for the first six months of 2008 compared to €
27.2 million for the same period in 2007. The decrease in R&D expenses
is primarily due to staff reductions as a result of the restructuring
plans implemented in 2007 and the first quarter of 2008, as well as a
decrease in clinical trial costs due to reduced clinical trial volumes.
In the first half of 2008, general and administrative (G&A) expenses
decreased 64% to € 7.6 million compared to €
21.2 million for the same period in 2007. The decrease in G&A expenses
is primarily due to staff reductions and other associated activities as
a result of the restructuring plans implemented in 2007 and the first
quarter of 2008. In addition, in the first half of 2007, the Company
incurred costs in connection with the building of a commercial
infrastructure and legal fees due to the arbitration proceedings. The
Company did not incur such costs in the first half of 2008. Net loss for
the first six months of 2008 improved 66% to €
(13.4) million compared to € (39.3) million
for the first six months of 2007. Basic and diluted loss per share was €
(0.36) for the first six months of 2008 compared to €
(1.10) for the same period in 2007.
Cash position
As of June 30, 2008, cash, cash equivalents, marketable securities and
short-term investments totaled € 44.6 million
(December 31, 2007: € 65.2 million),
including € 1.4 million in restricted cash. Net cash burn for the first six months of 2008 was €
18.7 million with net cash burn of € 10.6
million in the first quarter and € 8.1
million in the second quarter of 2008. Net cash burn, a non-GAAP
measure, is derived by adding net cash used in operating activities and
purchases of property, equipment and licenses. Net cash burn provides
insight regarding the actual cash a company spent in a given period. The
figures used to calculate net cash burn are contained in the Company’s
unaudited consolidated statements of cash flows for the first six months
ended June 30, 2008.
Second quarter of 2008 compared to second quarter of 2007
Revenues for the three months ended June 30, 2008 decreased 56% to €
1.5 million compared to € 3.4 million for the
same period in 2007. R&D expenses decreased 70% to €
4.5 million for the second quarter of 2008 compared to €
15.0 million for the same period in 2007. G&A expenses for the second
quarter of 2008 decreased 65% to € 4.0
million compared to € 11.4 million for the
second quarter of 2007. The Company’s net loss
was € (6.4) million in the second quarter of
2008 compared to € (22.1) million for the
same period in 2007. Basic and diluted loss per share was €
(0.17) for the second quarter of 2008 compared to €
(0.61) for the same period in 2007.
Quarter over quarter results: second quarter 2008 compared to
first quarter 2008
Revenues for the second quarter of 2008 were €
1.5 million compared to € 1.6 million for the
previous quarter. R&D expenses decreased 21% to €
4.5 million for the second quarter of 2008, compared to €
5.7 million in the first quarter of 2008. G&A expenses for the second
quarter of 2008 increased 11% to € 4.0
million compared to € 3.6 million for the
previous quarter. The Company’s net loss
decreased 9% to € (6.4) million in the second
quarter of 2008, compared to € (7.0) million
for the previous quarter. Basic and diluted loss per share was €
(0.17) for the second quarter of 2008 compared to €
(0.19) for the previous quarter.
"We are highly focused on rebuilding the
Company and are working with great intensity on moving forward promising
M&A opportunities,” said Bernd R.
Seizinger, M.D., Ph.D., Chief Executive Officer. "It
is critical that we broaden our oncology pipeline through such
transactional activities while we continue to advance our existing drug
development programs, including our two novel kinase inhibitors.” 2008 financial guidance
The Company confirmed its guidance provided in May 2008 as follows:
Revenues: Revenues for 2008 are
expected to be between € 5 million and €
7 million.
Once the termination of the co-development and license agreement between
GPC Biotech and Celgene Corporation for satraplatin for Europe and
certain other territories is effective, GPC Biotech expects to recognize
all or the majority of remaining deferred revenue related to the
agreement. This deferred revenue is related to cash already received by
GPC Biotech under this agreement. The Company will update revenue
guidance as appropriate.
Expenses: Total expenses for 2008
are expected to be below € 35 million.
Cash Burn: Current cash reserves
are expected to be sufficient to fund currently planned business
operations until approximately the end of 2010. The cash burn for 2008
will include several one-time costs, including severance and other
payments related to the corporate restructurings in 2007 and early 2008.
The majority of these one–time costs were
incurred in the first half of 2008.
This guidance does not include any potential M&A or other major
transactions, and, should such an event or events occur this year, the
Company’s financial expectations would likely
change significantly.
Conference call scheduled
The Company has scheduled a conference call to which participants may
listen via live webcast, accessible through the GPC Biotech Web site at www.gpc-biotech.com
or via telephone. A replay will be available on the Web site following
the live event. The call, which will be conducted in English, will be
held on August 13th at 14:00 CET/8:00 AM ET.
The dial-in numbers for the call are as follows:
Participants from Europe:
0049 (0)89 9982 99911 0044 (0)20 7806 1955
Participants from the U.S.:
1-718-354-1388
Please dial in 10 minutes before the beginning of the meeting.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on
anticancer drugs. GPC Biotech's lead product candidate is satraplatin,
an oral platinum compound. The Company has various anti-cancer programs
in research and development that leverage its expertise in kinase
inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich
(Germany) and has a wholly owned U.S. subsidiary in Princeton, New
Jersey. For additional information, please visit GPC Biotech's Web site
at www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech,
including statements about the Company’s
future cash position. Such statements are based on current
expectations and are subject to risks and uncertainties, many of which
are beyond our control, that could cause future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Actual results could differ materially depending on a number of factors,
and we caution investors not to place undue reliance on the
forward-looking statements contained in this press release. We
direct you to GPC Biotech’s Annual Report on
Form 20-F for the fiscal year ended December 31, 2007 and other reports
filed with the U.S. Securities and Exchange Commission for additional
details on the important factors that may affect the future results,
performance and achievements of GPC Biotech. Forward-looking statements
speak only as of the date on which they are made and GPC Biotech
undertakes no obligation to update these forward-looking statements,
even if new information becomes available in the future. – Financials follow – GPC Biotech AG
Condensed Consolidated Statements of Operations (U.S. GAAP)
Three months ended June 30,
Six months ended June 30,
in thousand €, except share and per
share data
2008 (unaudited)
2007 (unaudited)
2008 (unaudited)
2007 (unaudited)
Collaborative revenues
1,491
3,320
3,005
7,082
Grant revenues
42
67
97
144
Total revenues 1,533 3,387 3,102 7,226
Research and development expenses
4,533
14,976
10,282
27,214
General and administrative expenses
3,968
11,389
7,567
21,196
Amortization of intangible assets
17
90
35
181
Total operating expenses
8,518
26,455
17,884
48,591
Operating loss (6,985 ) (23,068 ) (14,782 ) (41,365 )
Other income (expense), net
83
(68
)
359
89
Interest income
474
1,049
1,079
2,077
Interest expense
(14
)
(40
)
(44
)
(67
)
Net Loss (6,442 ) (22,127 ) (13,388 ) (39,266 )
Basic and diluted loss per share
(0.17
)
(0.61
)
(0.36
)
(1.10
)
Shares used in computing basic and diluted loss per share
36,836,853 36,106,533 36,836,853 35,776,752
See accompanying notes to unaudited condensed consolidated
financial statements. GPC Biotech AG
Condensed Consolidated Balance Sheets
in thousand €, except share data and per
share data
June 30, December 31, Assets
2008 (unaudited)
2007
Current assets
Cash and cash equivalents
43,117
49,681
Marketable securities and short-term investments
113
14,077
Accounts receivable
348
984
Prepaid expenses
899
874
Other current assets
1,805
2,229
Restricted Cash
1,205
1,269
Total current assets 47,487 69,114
Property and equipment, net
2,272
3,070
Intangible assets, net
119
164
Other assets, non-current
753
851
Restricted cash
187
187
Total assets 50,818 73,386 Liabilities and shareholders' equity
Current liabilities
Accounts payable
2,368
2,826
Accrued expenses and other current liabilities
6,307
10,445
Current portion of deferred revenue
3,810
4,332
Total current liabilities 12,485 17,603
Deferred revenue, net of current portion
12,004
13,989
Convertible bonds
2,181
3,191
Shareholders' equity
Ordinary shares, € 1 non-par, notional
value:
Shares authorized: 70,383,150 at June 30, 2008 and December 31, 2007
Shares issued and outstanding: 36,836,853 at June 30, 2008 and
December 31, 2007
36,837
36,837
Additional paid-in capital
369,048
369,521
Accumulated other comprehensive loss
(5,634
)
(5,040
)
Accumulated deficit
(376,103
)
(362,715
)
Total shareholders' equity
24,148
38,603
Total liabilities and shareholders' equity 50,818 73,386
See accompanying notes to unaudited condensed consolidated
financial statements. GPC Biotech AG
Condensed Consolidated Statements of Cash Flows Six months ended June 30,
in thousand €
2008 (unaudited)
2007 (unaudited) Cash flows from operating activities:
Net loss
(13,388
)
(39,266
)
Adjustments to reconcile net loss to net cash provided by (used in)
operating activities:
Depreciation
521
862
Amortization
35
180
Compensation (reversal)/cost for stock option plans, convertible
bonds and SAR's
(463
)
2,267
Loss accrual on sublease contract and contract termination fee
110
(100
)
Change in accrued interest income on marketable securities
and short-term investments
-
(351
)
Other than temporary impairment on marketable securities
277
-
Bond premium amortization
19
105
Gain on disposal of property and equipment
(281
)
(43
)
Impairment of property and equipment
16
-
Changes in operating assets and liabilities:
Accounts receivable
636
(10,655
)
Other assets, current and non-current
412
117
Accounts payable
(373
)
1,473
Deferred revenue
(2,507
)
4,574
Other liabilities and accrued expenses, current and non-current
(3,744
)
144
Net cash used in operating activities (18,730 ) (40,693 )
Cash flows from investing activities:
Purchases of property, equipment and licenses
(15
)
(1,269
)
Proceeds from the sale of property and equipment
509
45
Proceeds from the sale or maturity of marketable securities and
short-term investments
13,830
11,000
Net cash provided by investing activities 14,324 9,776
Cash flows from financing activities:
Proceeds from issuance of shares, net of payments for cost of
transaction
-
32,633
Proceeds from issuance of convertible bonds
-
345
Repayment of convertible bonds
(1,250
)
(24
)
Proceeds from exercise of stock options and convertible bonds
-
5,384
Net cash (used in) provided by financing activities (1,250 ) 38,338
Effect of exchange rate changes on cash
(885
)
(784
)
Changes in restricted cash
(23
)
(35
)
Net (decrease) increase in cash and cash equivalents
(6,564
)
6,602
Cash and cash equivalents at the beginning of the period
49,681
38,337
Cash and cash equivalents at the end of the period 43,117 44,939
See accompanying notes to unaudited condensed consolidated
financial statements. GPC Biotech AG Consolidated Statements of Changes in Shareholders' Equity (in thousand €, except share data)
Ordinary shares
Additional Accumulated Other Total Subscribed Paid-in Comprehensive Accumulated Shareholders' Shares Amount Shares Capital Loss Deficit Equity
Balance at December 31, 2006
33,895,444
33,895
334
328,171
(1,755
)
(293,470
)
67,175
Components of comprehensive loss:
Net loss
(39,266
)
(39,266
)
Change in unrealized gain/(loss) on available-for-sale securities
146
146
Accumulated translation adjustments
(641
)
(641
)
Total comprehensive loss
(39,761
)
Issuance of shares
1,564,587
1,565
31,068
32,633
Exercise of stock options and conversion of convertible bonds
793,022
793
1,195
3,725
5,713
Compensation cost for stock options and convertible bonds
1,850
1,850
Balance at June 30, 2007 (unaudited)
36,253,053
36,253
1,529
364,814
(2,250
)
(332,736
)
67,610
Balance at December 31, 2007
36,836,853
36,837
-
369,521
(5,040
)
(362,715
)
38,603
Components of comprehensive loss:
Net loss
(13,388
)
(13,388
)
Change in unrealized gain/(loss) on available-for-sale securities
and other-than-temporary impairment
162
162
Accumulated translation adjustments
(756
)
(756
)
Total comprehensive loss
(13,982
)
Compensation cost for stock options and convertible bonds
(473
)
(473
)
Balance at June 30, 2008 (unaudited)
36,836,853
36,837
-
369,048
(5,634
)
(376,103
)
24,148
GPC Biotech AG Notes to the Unaudited Condensed Consolidated Financial Statements 1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements
of GPC Biotech AG (the "Company”)
have been prepared in accordance with accounting principles generally
accepted in the United States ("U.S. GAAP”),
applicable to interim financial reporting, specifically Accounting
Principles Board Opinion No. 28, Interim Financial Reporting, ("APB
28”). These unaudited condensed
consolidated financial statements do not include all information and
disclosures required for a complete set of financial statements.
However, in the opinion of management, all adjustments (consisting of
normal recurring adjustments) considered necessary for a fair
presentation have been included. Operating results for the three month
and six month period ended June 30, 2008, are not necessarily indicative
of results to be expected for the full year ending December 31, 2008.
The balance sheet at December 31, 2007, has been derived from the
audited consolidated financial statements at that date, but does not
include all of the information required by U.S. GAAP for complete
financial statements. For further information, please refer to the
consolidated financial statements and footnotes thereto for the year
ended December 31, 2007.
2. Business Developments
In July, 2008, Celgene Corporation withdrew the Marketing Authorization
Application MAA for satraplatin plus prednisone for the treatment of
hormone-refractory prostate cancer patients whose prior chemotherapy has
failed. Following the withdrawal of the MAA, in August 2008, GPC Biotech
received notice from Celgene of its decision to terminate its
co-development and license agreement with GPC Biotech for satraplatin in
Europe, Turkey, the Middle East, Australia and New Zealand. All rights
to these territories will be returned to GPC Biotech. The effects of
this decision on the Company’s financial
position and results of operations will be determined and reflected in
the consolidated financial statements when the termination has become
effective..
At this time, all currently ongoing trials with satraplatin are
continuing. The Company plans to talk further with Yakult, its partner
for the development and commercialization of satraplatin for Japan, to
evaluate the future of satraplatin and the direction in which the
Company should move with the compound.
3. New Accounting Pronouncements Accounting Pronouncements Adopted in the First Half of 2008
In September 2006, the Financial Accounting Standards Board ("FASB”)
issued Statement of Financial Accounting Standards No. 157, Fair
Value Measurements, ("SFAS 157”).
SFAS 157 defines fair value, establishes a framework for measuring fair
value in GAAP and expands disclosures about fair value measurements. In
February 2007, the FASB issued Statement of Financial Accounting
Standards No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, ("SFAS 159”).
SFAS 159 permits entities to choose to measure many financial
instruments and certain items at fair value that are not currently
required to be measured at fair value. The Company adopted these two
standards as of January 1, 2008. SFAS 157 affected the Company only to
the extent of its marketable securities and short-term investments
carried on a recurring basis at fair value using quoted prices in active
markets for identical assets, which is the Level 1 input in the SFAS 157
hierarchy. As of June 30, 2008, the fair value of marketable securities
and short-term investments amounted to € 0.1
million as included in the consolidated balance sheet. The Company did
not elect to measure other financial instruments and certain items at
fair value that were not currently required to be measured at fair
value, therefore, the adoption of SFAS 159 did not have a material
impact on its consolidated financial statements.
On June 14, 2007, the FASB ratified Emerging Issues Task Force 07-3, Accounting
for Non-Refundable Advance Payments for Goods or Services to Be Used in
Future Research and Development Activities, ("EITF
07-3”). EITF 07-3 requires that all
non-refundable advance payments for research and development activities
that will be used in future periods be capitalized until used. In
addition, the deferred research and development costs need to be
assessed for recoverability. EITF 07-3 is applicable for fiscal years
beginning after December 15, 2007 and is to be applied prospectively for
new contracts entered into on or after the effective date of this Issue.
The Company adopted this issue as of January 1, 2008 and it did not have
a material impact on its consolidated financial statements.
Accounting Pronouncements Not Yet Adopted
On December 12, 2007, the FASB ratified Emerging Issues Task Force 07-1, Accounting
for Collaborative Arrangements, ("EITF
07-1”). EITF 07-1 requires participants in a
collaborative arrangement to present the results of activities for which
they act as the principal on a gross basis and to report any payments
received from (made to) other collaborators based on other applicable
GAAP or, in the absence of other applicable GAAP, based on analogy to
authoritative or a reasonable, rational, and consistently applied
accounting policy election. Significant disclosures of the collaborative
agreements are also required. EITF 07-1 will be effective for annual
periods beginning after December 15, 2008, and is to be applied
retrospectively for collaborative arrangements existing at December 15,
2008, as a change of accounting principle. The Company does not expect
this issue to have a material effect on its consolidated financial
statements.
On May 22, 2008, the FASB issued Statement on Financial Accounting
Standards No. 162, The Hierarchy of Generally Accepted Accounting
Principles, ("SFAS 162”).
SFAS 162 identifies the sources of accounting principles and the
framework for selecting the principles to be used in the preparation of
financial statements of non-governmental entities that are presented in
conformity with U.S. GAAP (the GAAP hierarchy).The effective date of
SFAS 162 has yet to be determined; it becomes effective for both SEC
registrants and nonpublic entities 60 days after the SEC approves the
PCAOB’s amendments to AU Section 411, The
Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principals, of the AICPA Professional Standards, the
codified version of Statements of Accounting Standards 69. The Company
does not expect this statement to have a material effect on its
consolidated financial statements.
During its June 2008 meeting, the FASB ratified EITF 07-5, Determining
Whether an Instrument (or an Embedded Feature) Is Indexed to an Entity's
Own Stock, ("EITF 07-5”).
This Issue addresses the determination of whether an instrument (or an
embedded feature) is indexed to an entity's own stock, which is the
first part of the scope exception in paragraph 11(a) of FAS 133. If an
instrument (or an embedded feature) that has the characteristics of a
derivative instrument under paragraphs 6–9 of
FAS 133 is indexed to an entity's own stock, it is still necessary to
evaluate whether it is classified in stockholders' equity (or would be
classified in stockholders' equity if it were a freestanding
instrument). For example, a net-cash-settled stock purchase warrant may
be indexed to an entity's own stock, but it is not classified in
stockholders' equity. Other applicable authoritative accounting
literature, including Issues 00-19 and 05-2, provides guidance for
determining whether an instrument (or an embedded feature) is classified
in stockholders' equity (or would be classified in stockholders' equity
if it were a freestanding instrument). This Issue does not address that
second part of the scope exception in paragraph 11(a) of FAS 133. No
transition is required with respect to the evaluation of contingent
exercise provisions, because the Task Force affirmed the existing
consensus in Issue 01-6. However, when evaluating a settlement amount to
determine whether an instrument or embedded feature is indexed to an
entity's own stock, the FASB staff recommends that a consensus be
effective for financial statements issued for fiscal years beginning
after December 15, 2008, and interim periods within those fiscal years.
Early application is not permitted. The guidance in this Issue shall be
applied to outstanding instruments as of the beginning of the fiscal
year in which the Issue is initially applied. The Company is evaluating
the impact of this Issue on its consolidated financial statements.
4. Contingencies
From time to time, the Company may be party to certain legal proceedings
and claims which arise during the ordinary course of business. Legal
proceedings are subject to various uncertainties and the outcomes are
difficult to predict. GPC Biotech may incur significant expense in
defending these and future lawsuits. In the opinion of management, the
ultimate outcome of these matters, will not have material adverse
effects on the Company’s financial position,
results of operations or cash flows. In accordance with Statement of
Financial Accounting Standards No. 5, Accounting for Contingencies,
("SFAS 5”), the
Company makes a provision for a liability when it is both probable that
a liability has been incurred and when the amount of the loss is
reasonably estimable.
Shareholder Litigation
In July 2007, the Company and certain of its current and former officers
were sued in the United States District Court for the Southern District
of New York in three separate securities fraud class action lawsuits on
behalf of all persons who purchased the securities of GPC Biotech
between December 5, 2005 and July 24, 2007, inclusive. The suits have
since been consolidated and a lead plaintiff has been appointed. The
lead plaintiff's consolidated complaint was filed on March 12, 2008. The
consolidated complaint alleges that GPC Biotech violated U.S. federal
securities laws by making misleading public statements relating to the
prospects of its most advanced product candidate, satraplatin, and
thereby artificially inflating the price of GPC Biotech securities. The
consolidated complaint also names Bernd R. Seizinger (CEO) and three
former members of the Company's Management Board, Mirko Scherer, Elmar
Maier, and Sebastian Meier-Ewert, as defendants. The Company filed a
motion to dismiss the consolidated complaint on May 14, 2008 and the
plaintiff filed an opposition to said motion on June 30, 2008. The
Company filed a reply to the opposition on August 8, 2008.
The plaintiffs seek monetary damages in an unspecified amount. GPC
Biotech believes the allegations to be without merit and intends to
vigorously defend the Company. GPC Biotech cannot predict the outcome of
the suit and is not currently able to estimate the possible cost to the
Company from this suit.
Retention Plan
In 2008, the Company introduced a retention plan to retain key
employees. This retention plan consists of a cash bonus of approximately €440,000
to certain employees who continue to be employed through March 2009,
which is payable in the first quarter of 2009 and is being recognized
ratably over the future service period; and 906,000 stock options which
are being accounted for in accordance with SFAS 123R.
5. Loss per Share
Basic loss per ordinary share is computed using the weighted average
number of ordinary shares outstanding during the period. Diluted net
loss per ordinary share is computed using the weighted average number of
ordinary and dilutive ordinary equivalent shares from stock options and
convertible bonds where the dilutive effect of options and warrants was
calculated using the treasury stock method. For all periods presented,
diluted net loss per share is the same as basic net loss per share, as
the inclusion of weighted average shares of ordinary stock issuable upon
the exercise of stock options and convertible bonds would be
antidilutive.
6. Comprehensive Loss
Comprehensive loss was € 14.0 million and € 39.7
million for the six months ended June 30, 2008 and 2007, respectively.
Comprehensive loss is composed of net loss, unrealized gains and losses
on available-for-sale securities and cumulative foreign currency
translation adjustments. Accumulated other comprehensive loss on June
30, 2008, reflected € 5.6 million of
cumulative foreign currency translation loss adjustments. Accumulated
other comprehensive loss on June 30, 2007, reflected € 0.6
million of unrealized gains on marketable securities and short-term
investments and € 2.8 million of cumulative
foreign currency translation loss adjustments.
During the three months ended June 30, 2008, a loss was recognized in
the statement of operations for available-for-sale marketable equity
securities that were deemed to be other-than-temporarily impaired.
Accordingly, a loss in the amount of approximately €
277,000 was reclassified out of other comprehensive loss into other
income (expense), net, on the statement of operations.
7. Additional Disclosures Convertible Bonds
Convertible bonds for the six months ended June 30, 2008, decreased
35.3% to € 2.2 million compared to €
3.4 million as of December 31, 2007. The decrease in convertible bonds
is primarily due to the Company’s repayment
of convertible bonds as a result of the restructuring plans implemented
in 2007 and the first quarter of 2008; as described in detail in Note 10
of the consolidated financial statements as of December 31, 2007, and
below. As of June 30, 2008, and December 31, 2007, approximately €
0.2 million of convertible bonds are in other current liabilities due to
planned repayment of these bonds.
Revenue
Revenues for the six months ended June 30, 2008, decreased 56.9% to €
3.1 million compared to € 7.2 million for the
same period in 2007. The decrease in revenues is due to decreased
payments from Celgene relating to the on-going trials under the
co-development and license agreement for satraplatin.
Research and Development Expense
Research and development ("R&D”)
expenses for the six months ended June 30, 2008, decreased 62.1% to €
10.3 million compared to € 27.2 million for
the same period in 2007. The decrease in R&D expenses is primarily due
to staff reductions as a result of the restructuring plans implemented
in 2007 and the first quarter of 2008, as well as a decrease in clinical
trial costs due to reduced clinical trial volumes. Restructuring plans
are described in detail in Note 10 of the consolidated financial
statements as of December 31, 2007, and below.
General and Administrative Expenses
General and administrative ("G&A”)
expenses for the six months ended June 30, 2008, decreased 64.2% to €
7.6 million compared to € 21.2 million for
the same period in 2007. The decrease in G&A expenses is primarily due
to staff reductions and other associated activities as a result of the
restructuring plans implemented in 2007 and the first quarter of 2008.
In addition, in the first half of 2007, the Company incurred costs in
connection with the building of a commercial infrastructure and legal
fees due to the arbitration proceedings. The Company did not incur such
costs in the first half of 2008. Restructuring plans are described in
detail in Note 10 to the consolidated financial statements as of
December 31, 2007, and below.
Share-Based Compensation
For the six months June 30, 2008 and 2007, the Company recorded a credit
to share-based compensation cost of € (0.5)
million and incurred € 2.3 million in costs,
respectively. The 2008 credit is the result of the termination of stock
options and convertible bonds relating to the restructuring plans
implemented during 2007 and the first quarter of 2008. Upon termination,
compensation expense for awards for which the requisite service period
has not been rendered is reversed.
Product Candidate Licensing Activities
As discussed in Note 4 to the consolidated financial statements as of
December 31, 2007, in June 2007, the Company entered into a license
agreement with Yakult Honsha Co. Ltd. for development and
commercialization of satraplatin in Japan. The upfront license payment
of €7.4 million was included in deferred
revenue, non-current, as of June 30, 2008 and December 31, 2007, as the
Company was not able to estimate the period of substantial involvement
as of these balance sheet dates. The Company will continue to defer the
revenue until the timing of the satraplatin development plan, which
approximates the period of substantial involvement, can be reliably
determined.
Restructuring Activities
In February 2008, the Company announced a corporate restructuring to
sharpen its focus on oncology clinical development and to further reduce
costs. The restructuring was mainly focused on the Company’s
early-stage research activities in Munich and resulted in a reduction in
the total workforce of approximately 38% or 38 employees. The Company
recognized a restructuring charge of € 2.0
million during the first half of 2008. These charges primarily consisted
of employee severance and termination benefits and were included in both
research and development and general and administrative expenses. The
Company expects to incur an additional charge of €
0.1 million in 2008 relating to the February 2008 restructuring plan. In
addition, the Company recorded an adjustment reducing its 2007
restructuring accrual by € 161,000 due to
employee terminations that occurred earlier than initially determined.
Also in February 2008, Elmar Maier, Ph.D., Chief Operating
Officer/Martinsried and Senior Vice President, Business Development, and
Sebastian Meier-Ewert, Ph.D., Senior Vice President and Chief Scientific
Officer retired from their positions on the Management Board of the
Company by mutual consent, to allow for an appropriate resizing of the
Board, given the reduced size of the Company. Both Dr. Maier and Dr.
Meier-Ewert remain dedicated to the Company as advisors. Included in the
restructuring charge of € 2.0 million during
the first half of 2008, as mentioned above, is the accrual relating to
severance for these former Management Board members, which was paid in
April 2008.
A summary of the significant components of the restructuring liability
at June 30, 2008, is as follows (in thousand €):
Employee
Lease
Termination
Termination
Benefits
Costs
Total
January 1, 2008 Balance
2,327
2,214
4,541
Amortization of Lease Loss
-
(110
)
(110
)
Restructuring Charges
1,851
110
1,961
Restructuring Payments
(3,348
)
(1,349
)
(4,697
)
Adjustments / Changes in estimates
(161
)
-
(161
)
Exchange Differences
301
(223
)
78
June 30, 2008 Balance
970
642
1,612
A restructuring liability of € 1.6 million
and € 4.5 million as of June 30, 2008 and
December 31, 2007, respectively, is included in accrued expenses and
other current liabilities in the accompanying condensed consolidated
balance sheets. For further information, please refer to Note 10 to the
consolidated financial statements and footnotes thereto for the year
ended December 31, 2007.
Gain on Disposal of Property and Equipment
During the first half of 2008, the Company sold some of its assets
(mainly laboratory equipment and office furniture) majority of which had
been impaired in 2007, at both the Princeton and Munich facilities.
These assets had a historical cost of approximately €
1.6 million and a net book value of approximately €
0.3 million. The Company recorded a gain of approximately €
0.3 million relating to the sale of these assets.
8. Disclosures Required by the Frankfurt Stock Exchange Number of Employees
As of June 30, 2008 and 2007, the number of employees totalled 86 and
286, respectively.
Shareholdings of Management
As of June 30, 2008, the members of the Management Board and Supervisory
Board held shares, stock options, convertible bonds and stock
appreciation rights in the amounts set forth in the table below:
Number of Number of Number of Stock Number of Stock Convertible Appreciation
Shares
Options
Bonds
Rights Management Board
Bernd R. Seizinger, M.D., Ph.D. (Chairman)
111,499
789,000
1,413,501
-
Torsten Hombeck, Ph. D.
-
172,700
45,000
-
Supervisory Board
Jürgen Drews, M.D. (Chairman)
26,900
10,000
-
80,000
Michael Lytton (Vice Chairman)
7,500
10,000
-
60,000
Metin Colpan, Ph.D.
19,400
10,000
-
45,000
Donald Soltysiak
-
-
-
10,000
James Frates
1,000
-
-
60,000
Peter Preuss
87,500
-
-
50,000
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