08.11.2007 06:41:00
|
GPC Biotech Reports Financial Results for Third Quarter and First Nine Months of 2007
GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDax 30; NASDAQ: GPCB)
today reported financial results for the third quarter and first nine
months ended September 30, 2007.
First nine months of 2007 compared to first nine months of 2006
Revenues decreased 9% to € 16.1 million for
the nine months ended September 30, 2007, compared to €
17.6 million for the same period in 2006. Revenues were affected by
lower development funding received under the co-development and license
agreement with Pharmion for satraplatin in Europe and certain other
territories, as well as the expiration of various research collaboration
arrangements with ALTANA Pharma. The Company booked as revenue a €
5.9 million milestone payment from Pharmion in the third quarter of 2007
as a result of the acceptance of the Marketing Authorization Application
(MAA) for satraplatin by the European Medicines Agency (EMEA). Research
and development (R&D) expenses decreased 11% to €
43.7 million for the first nine months of 2007 compared to €
49.1 million for the same period in 2006. R&D expenses for the third
quarter 2007 include Spectrum’s portion of the €
5.9 million milestone payment from Pharmion. In the first nine months of
2007, general and administrative (G&A) expenses increased 130% to €
37.2 million compared to € 16.2 million for
the first nine months of 2006. The increase in G&A expenses is primarily
due to the formation of a sales and marketing organization in the first
half of 2007 in preparation for the potential launch of satraplatin that
was originally planned to occur in late 2007, as well as legal expenses.
For the first nine months of 2007, The Company reported restructuring
charges of € 1.7 million. These charges are
related to employee severance and termination costs related to the
closing of the Company’s Massachusetts
facility, announced in May 2007, and additional restructuring activities
in August 2007 that included a staff reduction in the U.S. The
restructuring charges are included in R&D and G&A expenses. Net loss for
the first nine months of 2007 increased 34% to €
(62.8) million compared to € (46.8) million
for the first nine months of 2006. Basic and diluted loss per share was €
(1.75) for the first nine months of 2007 compared to €
(1.44) for the same period in 2006.
Quarter over quarter results: third quarter 2007
compared to second quarter 2007
Revenues increased 162% to € 8.9 million for
the third quarter of 2007 compared to € 3.4
million for the previous quarter. R&D expenses decreased 3% to €
15.1 million for the third quarter of 2007, compared to €
15.5 million in the second quarter of 2007. G&A expenses for the third
quarter of 2007 increased 11% to € 13.8
million compared to € 12.4 million for the
previous quarter. The Company’s net loss
decreased 16% to € (20.0) million in the
third quarter of 2007, compared to € (23.7)
million for the previous quarter. Basic and diluted loss per share was €
(0.55) for the third quarter of 2007 compared to €
(0.66) for the previous quarter.
Comparison to previous year: third quarter 2007
compared to third quarter 2006
Revenues for the three months ended September 30, 2007 increased 35% to €
8.9 million compared to € 6.6 million for the
same period in 2006. R&D expenses decreased 25% for the third quarter of
2007 to € 15.1 million compared to €
20.1 million for the same period in 2006. G&A expenses for the third
quarter of 2007 increased 126% to € 13.8
million compared to € 6.1 million for the
same quarter in 2006. Net loss for the third quarter of 2007 increased
7% to € (20.0) million compared to €
(18.7) million for the third quarter of 2006. Basic and diluted loss per
share was € (0.55) for the third quarter of
2007 compared to € (0.56) for the same period
in 2006.
Cash position
As of September 30, 2007, cash, cash equivalents, marketable securities
and short-term investments totaled € 77.1
million (December 31, 2006: € 97.1 million),
including € 1.5 million in restricted cash.
Net cash burn for the first nine months of 2007 was €
58.6 million with net cash burn of € 19.4
million in the first quarter, € 22.6 million
in the second quarter and € 16.6 million in
the third quarter of 2007. Net cash burn is derived by adding net cash
used in operating activities and purchases of property, equipment and
licenses. The figures used to calculate net cash burn are contained in
the Company’s unaudited consolidated
statements of cash flows for the nine-month period ended September 30,
2007.
"This is the most challenging time that our
Company has faced in its ten-year history,”
said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "We
are finalizing a strategic plan for moving the Company forward, and we
will implement that plan in the weeks ahead. Part of that process will
involve a substantial restructuring to position the Company for future
success.”
Mirko Scherer, Ph.D., Senior Vice President and Chief Financial Officer
said, "We continue to expect to have around €
60 million in cash and equivalents at the end of 2007. We anticipate
that this amount will be sufficient to support our business operations
for approximately two years.” Updated financial guidance
GPC Biotech provided the following financial guidance.
Revenues for the full year 2007 expected to be in the range of €
17 to 19 million. This is consistent with previous guidance provided
in August.
Year-end 2007 cash, cash equivalents and available-for-sale securities
position expected to be approximately € 60
million. This is consistent with previous guidance provided in August.
Numerous cost-cutting measures to be implemented shortly, including a
significant workforce reduction.
Conference call scheduled
As previously announced, 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 via the Web site following
the live event. The call, which will be conducted in English, will be
held on November 8th at 15:00 CET/9:00 AM ET. The dial-in numbers for
the call are as follows:
Participants from Europe: 0049-(0)89-9982-99913 or 0044-(0)20-7806-1961
Participants from the U.S.: 1-718-354-1391
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
discovering, developing and commercializing new 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 headquartered 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 financial projections and forecasts relating to our operations
and financial situation. 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, 2006 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. GPC Biotech AG
Condensed Consolidated Statements of Operations
Three months ended September 30,
Nine months ended September 30,
in thousand €, except share and per share
data
2007 (unaudited)
2006 (unaudited)
2007 (unaudited)
2006 (unaudited)
Collaborative revenues (a)
8,848
6,480
15,930
17,303
Grant revenues
69
86
213
280
Total revenues 8,917 6,566 16,143 17,583
Research and development expenses
15,128
20,072
43,695
49,126
General and administrative expenses
13,833
6,070
37,232
16,247
Amortization of intangible assets
19
70
200
213
Total operating expenses
28,980
26,212
81,127
65,586
Operating loss (20,063 ) (19,646 ) (64,984 ) (48,003 )
Other income (expense), net
(664
)
(105
)
(575
)
(2,252
)
Interest income
785
1,084
2,862
3,120
Interest expense
(31
)
(21
)
(98
)
(65
)
Net loss before cumulative effect of change in accounting principle (19,973 ) (18,688 ) (62,795 ) (47,200 )
Cumulative effect of change in accounting principle
-
-
-
433
Net loss (19,973 ) (18,688 ) (62,795 ) (46,767 )
Loss per share before change in accounting principle
(0.55
)
(0.56
)
(1.75
)
(1.45
)
Cumulative effect of change in accounting principle
-
-
-
0.01
Basic and diluted loss per share (0.55 ) (0.56 ) (1.75 ) (1.44 )
Shares used in computing basic and diluted loss per share
36,375,359 33,208,042 35,978,772 32,554,200
(a) Revenues from related party
Collaborative revenues
-
2,483
-
5,827
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
September 30, December 31, Assets
2007 (unaudited)
2006 Current assets
Cash and cash equivalents
29,341
38,336
Marketable securities and short-term investments
46,302
57,186
Accounts receivable
2,986
11
Accounts receivable, related party
-
395
Prepaid expenses
1,199
1,299
Other current assets
3,283
2,970
Restricted Cash
1,293
-
Total current assets 84,404 100,197
Property and equipment, net
3,814
4,259
Intangible assets, net
188
405
Other assets, non-current
946
1,127
Restricted cash
187
1,531
Total assets 89,539 107,519 Liabilities and shareholders' equity
Current liabilities
Accounts payable
1,269
2,262
Accrued expenses and other current liabilities
13,469
14,346
Current portion of deferred revenue
5,385
7,240
Current portion of deferred revenue, related party
-
896
Total current liabilities 20,123 24,744
Deferred revenue, net of current portion
14,140
9,103
Convertible bonds
3,649
3,108
Other liabilities, non-current
-
3,389
Shareholders' equity
Ordinary shares, € 1 non-par, notional
value:
Shares authorized: 70,383,150 at September 30, 2007 and 62,695,630
at December 31, 2006
Shares issued and outstanding: 36,664,973 at September 30, 2007
and 33,895,444 at December 31, 2006
36,665
33,895
Additional paid-in capital
373,492
328,171
Subscribed shares
1,470
334
Accumulated other comprehensive loss
(3,735
)
(1,755
)
Accumulated deficit
(356,265
)
(293,470
)
Total shareholders' equity
51,627
67,175
Total liabilities and shareholders' equity 89,539 107,519
See accompanying notes to unaudited condensed consolidated
financial statements. Condensed Consolidated Statements of Cash Flows
Nine months ended September 30,
in thousand €
2007 (unaudited)
2006 (unaudited) Cash flows from operating activities
Net loss
(62,795
)
(46,767
)
Adjustments to reconcile net loss to net cash used in operating
activities:
Depreciation
1,284
1,324
Amortization
200
213
Compensation cost for stock option plans and convertible bonds
8,845
5,124
Loss accrual on sublease contract
(381
)
1,956
Cumulative effect of change in accounting principle
-
(433
)
Change in accrued interest income on marketable securities
and short-term investments
(405
)
(328
)
Bond premium amortization
159
468
Other than temporary impairment on marketable securities
-
390
(Gain)/loss on disposal of property and equipment
(17
)
(23
)
Changes in operating assets and liabilities:
Accounts receivable
(2,986
)
31,326
Accounts receivable, related party
395
1,436
Other assets, current and non-current
(154
)
959
Accounts payable
(910
)
(814
)
Deferred revenue
3,183
(11,356
)
Deferred revenue, related party
(896
)
(4,450
)
Other liabilities and accrued expenses, current and non-current
(2,651
)
3,791
Net cash (used in) provided by operating activities (57,129 ) (17,184 )
Cash flows from investing activities
Purchases of property, equipment and licenses
(1,479
)
(979
)
Proceeds from the sale of property and equipment
45
45
Proceeds from the sale or maturity of marketable securities and
short-term investments
11,000
20,445
Purchases of marketable securities and
short-term investments
-
(19,906
)
Net cash provided by (used in) investing activities 9,566 (395 )
Cash flows from financing activities
Proceeds from issuance of shares, net of payments for cost of
transaction
32,633
36,080
Proceeds from issuance of convertible bonds
1,006
140
Payments for cancellation of convertible bonds
(24
)
-
Proceeds from exercise of stock options and convertible bonds
5,154
1,032
Cash received for subscribed shares
2,080
-
Net cash provided by financing activities 40,849 37,252
Effect of exchange rate changes on cash
(2,229
)
(490
)
Changes in restricted cash
(52
)
(47
)
Net increase/(decrease) in cash and cash equivalents
(8,995
)
19,136
Cash and cash equivalents at the beginning of the period
38,336
30,559
Cash and cash equivalents at the end of the period 29,341 49,695
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 Shares
Amount Additional Paid-in Capital Subscribed Shares Accumulated Other Comprehensive Loss Accumulated Deficit Total Shareholders' Equity
Balance at December 31, 2005
30,151,757
30,152
284,931
-
(2,093
)
(229,457
)
83,533
Components of comprehensive loss:
Net loss
(46,767
)
(46,767
)
Change in unrealized gain on
available-for-sale securities
636
636
Accumulated translation
adjustments
(130
)
(130
)
Total comprehensive loss
(46,261
)
Issuance of shares
2,860,000
2,860
33,220
36,080
Exercise of stock options and
convertible bonds
251,641
252
874
1,126
Cumulative effect of change
in accounting principle
(433
)
(433
)
Compensation cost for stock options
and convertible bonds
5,124
5,124
Balance at September 30, 2006 (unaudited)
33,263,398
33,264
323,716
-
(1,587
)
(276,224
)
79,169
Balance at December 31, 2006
33,895,444
33,895
328,171
334
(1,755
)
(293,470
)
67,175
Components of comprehensive loss:
Net loss
(62,795
)
(62,795
)
Change in unrealized gain on
available-for-sale securities
(129
)
(129
)
Accumulated translation
adjustments
(1,851
)
(1,851
)
Total comprehensive loss
(64,775
)
Issuance of shares
1,564,587
1,565
31,068
32,633
Exercise of stock options and
convertible bonds
1,204,942
1,205
5,333
1,136
7,674
Compensation cost for stock options
and convertible bonds
8,920
8,920
Balance at September 30, 2007 (unaudited)
36,664,973
36,665
373,492
1,470
(3,735
)
(356,265
)
51,627
See accompanying notes to unaudited condensed consolidated
financial statements 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". 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 nine-month periods ended September 30, 2007, are not
necessarily indicative of results to be expected for the full year
ending December 31, 2007. The balance sheet at December 31, 2006 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, refer to the
consolidated financial statements and footnotes thereto for the year
ended December 31, 2006.
2. New Accounting Pronouncements
As of January 1, 2007, GPC Biotech adopted FASB Interpretation No. 48,
"Accounting for Uncertainty in Income Taxes,
an interpretation of FASB Statement No. 109”
(FIN 48). The Company has certain deferred tax assets as a result of
several years of losses from operations. Management determined that it
was not probable that sufficient future taxable income would be
available to realize those deferred tax assets, therefore, management
recognized a full valuation allowance for those deferred tax assets.
The Company’s policy is to accrue interest
and penalties on the tax obligations and classify them as current or
non-current depending on when the amount is anticipated to be paid.
Currently, the Company does not take any other tax positions nor has any
interest or penalties.
On June 14, 2007, the Financial Accounting Standards Board ("FASB")
ratified EITF 07-3, "Accounting for
Non-Refundable Advance Payments for Goods or Services to Be Used in
Future Research and Development Activities”.
EITF 07-3 requires that all non-refundable advance payments for R&D
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
without the option of early application. The Company will evaluate the
impact, if any, of EITF 07-3 on its financial statements.
3. Related Party Disclosures
ALTANA Pharma AG ("ALTANA Pharma”)
is no longer a related party to the Company because the board membership
of Dr. Bernd Seizinger at ALTANA Pharma ended December 31, 2006.
Therefore, transactions consummated with ALTANA Pharma from and after
January 1, 2007, are no longer classified as transactions with a related
party.
4. Commitments and Contingencies Contingent Commitments and Contingent Losses
From time to time, the Company may be party to certain legal proceedings
and claims which arise during the ordinary course of business. The
Company also has other contingencies relating to potential milestone
payments. Legal proceedings and contingent commitments are subject to
various uncertainties and the outcomes are difficult to predict. GPC
Biotech may incur significant expense in defending these or future legal
proceedings and in fulfilling these contingencies, however, 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 SFAS No. 5, "Accounting for
Contingencies”, the Company makes a
provision for a liability when it is both probable that a liability has
been incurred at the date of the financial statements and when the
amount of the loss is reasonably estimable. With respect to a number of
the items listed below, management has determined that a loss is not
probable or the amount of the loss is not reasonably estimable, or both.
Arbitration Proceedings
On December 12, 2006, the Company was notified by Spectrum
Pharmaceuticals Inc. ("Spectrum”),
that Spectrum had initiated an arbitration proceeding with the American
Arbitration Association in the United States to resolve a dispute
between the companies under the co-development and license agreement for
satraplatin. In the course of the arbitration proceedings, Spectrum has
made several claims of breach of contract, including (1) an assertion
that it is entitled to a payment from GPC Biotech of approximately €
9.0 million relating to payments received by GPC Biotech under the
co-development and license agreement between GPC Biotech and Pharmion
GmbH entered on December 19, 2005, (2) a claim that GPC Biotech has not
used commercially reasonable efforts to obtain regulatory approval and
to promote the distribution of satraplatin in Japan, and (3) a claim
that GPC Biotech has not negotiated with Spectrum in good faith
regarding the co-promotion of satraplatin in the United States. Spectrum
is also seeking a declaration that GPC Biotech’s
alleged breaches of contract provide a basis for termination of the
co-development and license agreement. The Company believes that Spectrum’s
claims have no merit and is therefore contesting such claims vigorously.
Management assessed the prospect of an unfavorable outcome of this
arbitration as less than probable. The hearing was completed on July 13,
2007 and closing arguments were held at the end of August 2007. On
November 5, 2007, the Company announced the arbitration panel issued its
decision. Please refer to footnote 10 "Subsequent
Events” for further details.
Fees which the Company pays to its external legal advisors and for other
services associated with this arbitration process are expensed in the
period when such legal and other services are rendered.
Shareholder Litigation
On July 27, 2007, the Company announced that it had been sued in the
United States District Court for the Southern District of New York,
purportedly in a class action lawsuit on behalf of all persons who
purchased or acquired securities of GPC Biotech between December 5, 2005
and July 24, 2007 inclusive. The suit also named the Company’s
Chief Executive Officer and two other executives of the Company. The
complaint alleges that GPC Biotech violated U.S. federal securities laws
by making materially false public statements relating to satraplatin,
thereby inflating the price of GPC Biotech securities. Since the date of
that announcement two other similar lawsuits have been filed against the
Company. Other similar lawsuits may be filed.
The complaints in these lawsuits seek monetary damages in an unspecified
amount. GPC Biotech believes the allegations in the complaints to be
without merit and intends to vigorously defend the Company. GPC Biotech
cannot predict the outcome of any of these suits and is not currently
able to estimate the possible cost to the Company from these suits,
given the early stage of the proceedings.
Marketing Approval of Satraplatin in Europe
Upon receiving marketing approval for satraplatin in Europe, the Company
is required to make the following payments:
Under the Company’s agreement with
Spectrum, GPC Biotech is obligated to make a milestone payment for
this approval in the total amount of approximately €
2.1 million.
The Company has a cash bonus plan to retain the Company’s
employees in which the total payout may lead to an increase in
personnel expenses of up to € 0.6 million.
The Company issued stock appreciation rights (SARs) to senior
management, the members of the Supervisory Board, and certain
employees. These SARs would entitle the holder to cash payments if the
performance condition were to be met.
The Company records the expense associated with these milestones as the
events become probable.
Acceptance of NDA Filing
On April 16, 2007, the U.S. Federal Drug Administration (FDA) accepted
the Company’s filing of the New Drug
Application (NDA) for satraplatin for patients with hormone-refactory
prostate cancer (HRPC) whose prior chemotherapy has failed. In
connection with this acceptance, the Company was required to pay
approximately € 2.9 million to Spectrum.
This payment was made in May 2007, however, charged to research and
development expense in 2006 when the occurrence of this event was deemed
probable.
On July 30, 2007, the Company announced that it had withdrawn the
satraplatin capsules NDA filed for accelerated approval for the
treatment of hormone-refractory prostate cancer patients whose prior
chemotherapy has failed. The Company based its decision on the vote by
the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug
Administration (FDA) on July 24, 2007 that the FDA should wait for the
final survival analysis of the SPARC trial before deciding whether
satraplatin is approvable.
On October 31, 2007, the Company announced that the SPARC trial did not
achieve the endpoint of overall survival. Please refer to footnote 10 "Subsequent
Events” for further details.
Acceptance of MAA by EMEA
In July 2007, the European Medicines Agency (EMEA) accepted Pharmion’s
filing of the Marketing Authorization Application (MAA) for satraplatin
in combination with prednisone for the treatment of patients with
metastatic hormone refractory prostate cancer whose prior chemotherapy
has failed. As a result of the MAA acceptance by the EMEA, GPC Biotech
received a € 5.9 million milestone payment
from Pharmion. Also, under the terms of GPC Biotech’s
agreement with Spectrum, the acceptance of the MAA by the EMEA triggered
payments by GPC Biotech to Spectrum in the total amount of approximately €
2.4 million, representing a direct milestone payment plus Spectrum’s
portion of the € 5.9 million milestone
payment from Pharmion.
Development and Supply Agreement
GPC Biotech is the owner and licensee of certain technology and patent
rights regarding the monoclonal antibody known as 1D09C3. In March 2007,
GPC Biotech entered into a development and supply agreement with a
biologics supplier under which the biologics supplier agreed to: (1)
develop a high-productivity cell line and develop and scale-up a robust
manufacturing process and (2) produce quantities of 1D09C3 bulk drug
substance for clinical development and commercial supply. Pursuant to
the agreement, GPC Biotech is required to make certain payments over a
period of 7 (seven) years. These payments are charged to research and
development expenses as services are rendered. In the third quarter 2007
the Company decided to not make additional financial commitments to its
1D09C3 monoclonal antibody program at this time. However, the Company
plans to maintain the capability to accelerate this program at a later
date.
Contingent Gains
The Company is entitled to receive a milestone payment from Pharmion
(net of licensing fee paid to Spectrum) of approximately €
11.6 million upon the approval of the MAA for satraplatin with the EMEA.
Gross receipt will be recognized as revenue upon milestone achievement.
5. Loss per Share
Basic loss per common share is computed using the weighted average
number of common shares outstanding during the period. Diluted net loss
per common share is computed using the weighted average number of common
and dilutive common equivalent shares from stock options and convertible
debt 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 common stock issuable upon the exercise of
stock options and convertible debt would be antidilutive.
6. Comprehensive Loss
Comprehensive loss was € 64.8 million and € 46.2
million for the nine months ended September 30, 2007 and 2006,
respectively. Comprehensive loss is composed of net loss, unrealized
gains and losses on marketable securities and short-term investments and
cumulative foreign currency translation adjustments. Accumulated other
comprehensive loss at September 30, 2007 and 2006 reflected € 0.3
million and € 0.4 million of unrealized
gains on marketable securities and short-term investments and € 4.0
million and € 2.0 million of cumulative
foreign currency translation loss adjustments, respectively.
7. Shareholders’ Equity
On January 24, 2007, the Company issued 1,564,587 new ordinary shares at € 21.50
per share for a total net amount of € 32.6
million through a private placement. GPC Biotech received the proceeds
from the placement in February 2007.
At September 30, 2007, employees of the Company had subscribed to
166,000 ordinary shares with a total value of €
1.5 million, which has been included in shareholders’
equity. The subscribed shares represent amounts paid for exercises of
stock options for which ordinary shares have not been issued at
September 30, 2007. The ordinary shares are expected to be registered
and issued by December 31, 2007.
During the nine months ended September 30, 2007, members of the
Management Board and employees of the Company exercised some of their
fully vested stock options and convertible bonds, receiving 1,204,942
new ordinary shares of the Company.
8. Additional Disclosures General and Administrative Expenses
General and administrative (G&A) expenses for the nine months ended
September 30, 2007 increased 130% to € 37.2
million compared to € 16.2 million for the
same period in 2006. The increase in G&A expenses is primarily due to
the formation of a sales and marketing organization in the first half of
2007 in preparation of the potential product launch of satraplatin in
the U.S. as well as various legal expenses. However, the Company has
since implemented certain restructuring measures, including the
restructuring plan announced on August 23, 2007 as described below.
Share-Based Compensation
For the nine months ended September 30, 2007 and 2006, the Company
incurred share-based compensation cost of € 8.8
million and € 5.1 million, respectively.
This increase is the result of additional stock option and convertible
bond grants combined with the recognition of certain stock appreciation
rights.
Product Candidate Licensing Activities
On June 25, 2007, the Company entered into a license agreement with
Yakult Honsha Co. Ltd. ("Yakult")
for satraplatin in Japan. Under the terms of the agreement, Yakult gains
exclusive commercialization rights to satraplatin for Japan and will
take the lead in developing the drug in Japan. Under the agreement,
Yakult was required to make an upfront payment of ¥1.2
billion (€ 7.4 million) to the Company as
reimbursement for past satraplatin development expenses. Payment was
received in July 2007, net of a withholding tax payment to the Japanese
government totalling €0.7 million which was
recorded in Other Income (Expense), net.
This agreement has more than one deliverable and has been accounted for
following the guidance provided by EITF 00-21. In accordance with EITF
00-21, all of the revenue associated with this agreement has been
deferred and will be recognized over the Company’s
period of substantial involvement in this agreement which was determined
to coincide with the Yakult’s product
development plan of 48 months. However, due to the recent topline
overall survival results for the double-blinded, randomized satraplatin
Phase 3 registrational trial, the SPARC trial, the Company determined
that adjustments may be necessary to that original estimate and will
continue to defer all revenues associated with the agreement until its
impact can be reliably determined.
Also, according to the license agreement with Yakult, Yakult is
obligated to make additional payments to the Company based on the
achievement of certain regulatory filing and approval milestones. These
revenues (if any) will be recognized when the milestone is achieved. In
addition, the Company will receive a minimum of 21.1% royalties on net
sales of satraplatin in Japan.
Costs Associated with Exit Activities
On May 3, 2007, the Company announced the consolidation of its drug
discovery efforts to one location, resulting in the closing of the
facility in Waltham, Massachusetts, USA along with a total workforce
reduction of approximately 16%. The Company has accounted for this
restructuring in accordance with SFAS No. 146, "Accounting
for Costs Associated with Exit or Disposal Activities” (FAS 146). Under FAS 146, the Company incurred a
restructuring charge of € 0.9 million in the
second quarter of 2007 and minimal costs in the third quarter of 2007,
primarily relating to employee severance and termination costs. These
charges are included in both Research and Development and General and
Administrative expenses at September 30, 2007.
In addition, the Company has incurred and will continue to incur certain
contract termination costs relating to the closing of the Waltham
facility. Prior to the announcement of the reorganization the Company
had a remaining sublease loss liability relating to the same facility
totaling € 4.0 million which was charged to
expense in prior years in accordance with FAS 146. Because this
liability was deemed adequate to cover all contract termination costs
and professional fees associated with this restructuring, no additional
amounts have been charged to expense in the current year. However,
during the third quarter of 2007, the Company adjusted this liability
down as the Company’s facility closing costs
and legal expenses are believed to be lower than originally anticipated.
This reduction was recorded to General and Administrative Expense.
The Company expects to complete this reorganization by December 31,
2007, incurring a total charge of approximately €
1.0 million. These charges are included in both Research and Development
and General and Administrative expenses at September 30, 2007.
During the third quarter 2007, the Company recorded an impairment charge
of approximately €0.5 million which
represents the carrying value of the fixed assets that were disposed of
at the Waltham facility. This charge primarily related to laboratory
equipment and furniture and was recorded in General and Administrative
expense in accordance with FAS 144 "Accounting
for the Impairment or Disposal of Long-Lived Assets”.
On August 23, 2007, the Company announced a restructuring plan that
involved a staff reduction of 46 out of 316 employees, or approximately
15% of the total workforce. All affected staff were based in the U.S.,
with reductions in the commercialization, drug development and general
and administrative groups. The Company also accounted for this
reorganization under FAS 146, incurring a total restructuring charge of €
0.7 million in the third quarter of 2007, primarily relating to employee
severance and termination costs. This restructuring was completed on
August 31, 2007. The charges are included in both Research and
Development and General and Administrative expenses for the nine months
ending September 30, 2007.
A summary of the significant components of the restructuring liability
is as follows (in thousand €):
Employee
Facility
Termination Closing Benefits Costs Total
January 1, 2007 balance
-
3,967
3,967
Amortization of sublease loss including interest
-
(381
)
(381
)
Restructuring charges
1,655
-
1,655
Restructuring payments
(687
)
-
(687
)
Adjustments / Changes in estimates
-
(506
)
(506
)
Exchange differences
(64
)
(246
)
(310
)
September 30, 2007 balance 904
2,834
3,738
Supervisory Board
At the Company’s Annual Shareholders Meeting
on May 25, 2007, Donald Soltysiak was elected to its Supervisory Board.
Mr. Soltysiak succeeded Dr. Prabhavathi Fernandes, whose term ended on
the same day.
9. Disclosures Required by the Frankfurt Stock Exchange Number of Employees
As of September 30, 2007 and 2006, the number of employees totalled 248
and 228, respectively.
Shareholdings of Management
As of September 30, 2007, 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 Shares
Number of Stock Options
Number of Convertible Bonds
Number of Stock Appreciation Rights Management Board
Bernd R. Seizinger, M.D., Ph.D. (Chairman)
61,500
789,000
1,413,501
-
Elmar Maier, Ph.D.
170,000
95,000
358,000
-
Sebastian Meier-Ewert, Ph.D.
194,405
189,000
424,375
-
Mirko Scherer, Ph. D.
7,776
215,000
413,000
-
Supervisory Board
Jürgen Drews, M.D. (Chairman)
26,900
10,000
12,500
80,000
Michael Lytton (Vice Chairman)
7,500
10,000
31,500
60,000
Metin Colpan, Ph.D.
19,400
10,000
10,000
45,000
Donald Soltysiak
-
-
-
10,000
James Frates
1,000
-
-
60,000
Peter Preuss
87,500
-
22,500
50,000
10. Subsequent Events SPARC Trial
On October 31, 2007, the Company announced topline overall survival
results for the double-blinded, randomized satraplatin Phase 3
registrational trial, the SPARC trial. The trial evaluated satraplatin
plus prednisone versus placebo plus prednisone as a second-line
treatment in 950 patients with HRPC. The Company reported that the trial
did not achieve the endpoint of overall survival (p=0.80, stratified log
rank analysis). The median was 61.3 weeks for the satraplatin arm
compared to 61.4 weeks for the control group and the hazard ratio was
0.97 (95% CI: 0.83, 1.13). The Company is currently conducting
pre-specified subset analyses. Based on the results, GPC Biotech is
re-evaluating its development plans for satraplatin.
Arbitration Decision
On November 5, 2007, the Company announced that a three-arbitrator panel
of the American Arbitration Association, which was appointed to resolve
a dispute over claims raised by Spectrum against GPC Biotech regarding
the co-development and license agreement for satraplatin, issued its
decision in favor of GPC Biotech. The panel unanimously rejected all of
Spectrum’s claims and found no violations of
the agreement by GPC Biotech. The decision of the panel included the
following key rulings:
• Spectrum is not entitled to any portion of
the up-front payments that GPC Biotech received from Pharmion
Corporation or from Yakult;
• Spectrum does not have a contractual right
to co-promote satraplatin in the United States and GPC Biotech did not
violate any obligation to negotiate in good faith a co-promotion
agreement; and
• GPC Biotech did not violate its obligation
to use commercially reasonable efforts to commercialize satraplatin in
Japan.
Although the panel ruled for GPC Biotech on the merits, it did not award
GPC Biotech re-imbursement of attorneys’ fees
and costs.
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
JETZT DEVISEN-CFDS MIT BIS ZU HEBEL 30 HANDELN
Handeln Sie Devisen-CFDs mit kleinen Spreads. Mit nur 100 € können Sie mit der Wirkung von 3.000 Euro Kapital handeln.
82% der Kleinanlegerkonten verlieren Geld beim CFD-Handel mit diesem Anbieter. Sie sollten überlegen, ob Sie es sich leisten können, das hohe Risiko einzugehen, Ihr Geld zu verlieren.
Nachrichten zu Genuine Parts Co.mehr Nachrichten
Analysen zu Genuine Parts Co.mehr Analysen
Aktien in diesem Artikel
Genuine Parts Co. | 113,55 | -0,22% |
Indizes in diesem Artikel
S&P 500 | 6 061,48 | 0,39% | |
FTSE GLOB AUTOS | 2 979,46 | 0,05% |