27.11.2007 19:00:00
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LifeCycle Pharma: Interim Report For the 9 Months Ended 30 September 2007
LifeCycle Pharma A/S (OMX: LCP):
LCP-Tacro, LifeCycle Pharma’s proprietary,
once-daily tacrolimus tablet for the treatment of organ transplant
patients, has demonstrated a best in class profile when compared to both
Prograf® and Advagraf®,
the only two other tacrolimus products currently marketed. Interim
results from the ongoing Phase II clinical trial in kidney transplant
patients show that LCP-Tacro has a superior profile when compared to
Prograf, including better pharmacokinetics, once-a-day tablet
formulation and higher bioavailability. In addition, the completed Phase
I head-to-head clinical trial of LCP-Tacro versus Advagraf for the
prevention of organ rejection after transplantation confirmed that
LCP-Tacro has approximately 50% higher bioavailability, a flatter
product profile, and potential for administration at lower daily doses
when compared to Advagraf.
Dear Shareholder,
For the third quarter of 2007, LifeCycle Pharma reported a net loss of
DKK 2.2 million (approximately EUR 0.3 million) compared to a net loss
of DKK 36.9 million (approximately EUR 5.0 million) for the same period
in 2006. Combined with the net loss for the first half of 2007,
Lifecycle Pharma has reported a net loss of DKK 87.9 million
(approximately EUR 11.8 million) for the first nine months of 2007. The
corresponding net loss for the first nine months of 2006 was DKK 101.0
million (approximately EUR 13.6 million). During the first nine months
of 2007, LifeCycle Pharma recognized DKK 60.7 million (approximately EUR
8.1 million) in revenues compared to DKK 4.0 million (approximately EUR
0.5 million) in the same period of 2006. Milestone payments of USD 9
million under the LCP-FenoChol collaboration with Sciele Pharma were
recognized as revenues in the third quarter of 2007.
For the first nine months of 2007, LifeCycle Pharma’s
research and development costs amounted to DKK 120.6 million
(approximately EUR 16.2 million) compared to DKK 87.9 million
(approximately EUR 11.8 million) during the same period in 2006. The
higher research and development costs reflect the increased activity in
the company’s pipeline, primarily the costs
related to the clinical trials carried out, including two Phase II
clinical studies for LCP-Tacro and LCP-AtorFen, but also costs related
to the increased number of employees working within research and
development. Administrative expenses increased from DKK 16.8 million
(approximately EUR 2.2 million) in the first nine months of 2006 to DKK
38.1 million (approximately EUR 5.1 million) in the first nine months of
2007. This increase is attributable to the general strengthening of
administrative functions following the company’s
IPO in November 2006, leading to increased personnel expenses and
warrant compensation costs. Further, the company has established an
investor relation function and a subsidiary in the US.
At 30 September 2007, LifeCycle Pharma had cash and cash equivalents of
DKK 397.4 million (approximately EUR 53.3 million).
Outlook for 2007
Based on the results for the nine months ended 30 September 2007,
LifeCycle Pharma has improved its financial guidance for the year.
In earlier disclosed financial guidance for 2007, expressed in the
Annual Report for 2006, Lifecycle Pharma projected an operating loss of
DKK 260 to 285 million and a net loss in the range of DKK 255 to 280
million.
Even though the company has already fulfilled most of the clinical and
regulatory milestones set up for 2007, it has been able to demonstrate
significant cost savings compared to the original guidance. Accordingly,
the company is now projecting an operating loss for 2007 of DKK 160 to
185 million and a net loss in the range of DKK 145 to 170 million. The
improved expectations for the year’s result
arise from general savings in the clinical studies and a lower USD-rate
than anticipated, combined with higher financial income, and the ability
of meeting the company’s business and
scientific milestones with a lower number of employees than anticipated.
Further, the cash position is positively affected by higher proceeds
from the exercise of employee warrants.
Previously, the company’s cash position at
year end was expected to be in the range of DKK 215 to 240 million.
Based on the above changes in the financial guidance, the company is now
expecting a 31 December 2007 cash position in the range of DKK 315 to
340 million.
The above estimates are subject to possible change primarily due to the
timing and variation of clinical activities, related costs and
fluctuating exchange rates. Also, no further outlicense agreements are
expected this year.
Highlights for the Third Quarter of 2007
During the third quarter of 2007, LifeCycle Pharma continued the
positive development from the first half year and achieved the following
major business and scientific milestones:
On 12 July 2007, LifeCycle Pharma announced the initiation of a US
Phase II clinical trial program using LCP-AtorFen, a fixed-dose
combination of atorvastatin and fenofibrate, for the treatment of
patients with mixed dyslipidemia. LCP-AtorFen will be a powerful and
safe treatment of high cholesterol levels, addressing three primary
cardiovascular risk factors: low density lipoprotein cholesterol
(LDL-C), high density lipoprotein cholesterol (HDL-C) and
triglycerides (TG).
In August 2007, LifeCycle Pharma received US FDA approval for its
novel formulation of fenofibrate in 120 mg and 40 mg dosage strengths
for the treatment of hyperlipidemia and hypertriglyceridemia. This
fenofibrate utilizes LifeCycle Pharma’s
MeltDose technology which is designed to provide enhanced absorption
and greater bioavailability for certain orally delivered products. The
FDA approval triggered a milestone payment to LifeCycle Pharma of USD
4 million, which, together with the upfront payment of USD 5 million
received when signing the agreement with Sciele Pharma, was recognized
as revenues in the third quarter of 2007.
Subsequent Events
On 26 October 2007, LifeCycle Pharma announced positive interim Phase II
clinical trial results for LCP-Tacro for the treatment of kidney
transplant patients. The interim results based on 10 patients showed
that LCP-Tacro had a superior profile when compared to Prograf,
including better pharmacokinetics (PK), once-a-day tablet formulation
and higher bioavailability. Prograf is currently marketed worldwide by
Astellas Pharma as twice-a-day capsules of tacrolimus.
On 7 November 2007, LifeCycle Pharma announced results from a Phase I
head-to-head clinical trial comparing LCP-Tacro to Advagraf, currently
marketed in a few European countries as a once-daily capsule version of
tacrolimus. The results of the trial, which was designed as a multi-dose
trial enrolling 19 healthy volunteers, confirmed that LCP-Tacro has
approximately 50% higher bioavailability, a flatter product profile
(i.e. a lower Cmax/Cmin, or peak-to-trough ratio), and potential for
administration at lower daily doses when compared to Advagraf.
On 20 November 2007, LifeCycle Pharma announced that it had completed
patient enrollment in its Phase II clinical trial of LCP-AtorFen for the
treatment of mixed dyslipidemia to compare LCP-AtorFen with Lipitor®
(40 mg atorvastatin calcium tablets) and Tricor®
(145 mg fenofibrate tablets). In addition, the company announced that it
has initiated a 52-week, open-label extension study in order to capture
additional safety and efficacy data on the use of LCP-AtorFen in
patients with mixed dyslipidemia.
Product Pipeline
During the third quarter of 2007 LifeCycle Pharma continued to develop
its broad portfolio of products in various stages of development. As per
end of September 2007 the clinical pipeline includes six product
candidates.
1. LCP-FenoChol (containing 120 mg / 40 mg active substance)
is a tablet formulation of fenofibrate, a cholesterol-lowering
therapeutic substance, indicated for the treatment of hyperlipidemia and
hypertriglyceridemia. LCP-FenoChol was approved by the US FDA in August
2007.
Under the existing Iicense agreement with Sciele Pharma, Inc. regarding
the rights to market fenofibrate in 120 mg and 40 mg strengths in the
US, Canada, and Mexico, Sciele Pharma has expressed that they expect to
launch the product before year end.
2. LCP-Tacro (organ transplant) is being developed as a
proprietary, best-in-class (once-daily) tacrolimus tablet. Tacrolimus is
a market leading immunosuppressant used to prevent the body from
rejecting a transplanted organ.
Positive interim Phase II data for LCP-Tacro for the treatment of kidney
transplant patients demonstrates a superior profile for LCP-Tacro when
compared to Prograf, including better pharmacokinetics (PK), once-a-day
tablet formulation and higher bioavailability. The study is designed as
a three sequence, open-label, multi-center, prospective, conversion
study in stable kidney transplant patients to assess and compare the
pharmacokinetics and safety of LCP-Tacro tablets once-a-day versus
Prograf capsules twice-a-day. Phase II clinical data are expected by
year end 2007 or early 2008.
LifeCycle Pharma has completed a Phase I head-to-head clinical trial
comparing LCP-Tacro to Advagraf, currently marketed in Europe by
Astellas Pharma as a once-daily capsule version of tacrolimus. The data
confirmed that LCP-Tacro demonstrated approximately 50% higher
bioavailability, flatter product profile and potential for
administration at lower daily doses when compared to Advagraf.
A Phase II clinical study in liver transplant recipients has been
initiated and the treatment of the first patients with LCP-Tacro is
planned for the end of November 2007.
3. LCP-Tacro (autoimmune) is designed to be a strong
immunosuppressant that LifeCycle Pharma believes may be effica?cious
not only in preventing organ rejection after transplantation but also in
a number of autoimmune diseases. In many of these disease categories,
patients today risk disability or death. Physicians can currently, often
as last resorts, only offer expensive, injectable antibody therapy,
long-term, high-dose steroid therapy or other drugs with severe side
effects. The efficacy of tacrolimus has been shown in several of these
indications, but Lifecycle Pharma believes the usage of tacrolimus has
been hampered by the inconve?nience,
variability and unwanted side effects associ?ated
with the current formulation. Issues that the company believes could be
eliminated with LCP-Tacro.
Based on the positive results from the clinical programmes with
LCP-Tacro, LifeCycle Pharma is currently evaluating development and
registration strategies for a number of potential indications, and
expects to initiate Phase II studies in one autoimmune therapy area
before the end of 2007. Where appropriate, LifeCycle Pharma may seek
orphan drug status.
4. LCP-AtorFen is a fixed-dose combination therapy for the
treatment of high cholesterol levels, combining atorvastatin (the active
ingredient of Lipi?tor®
currently marketed by Pfizer) and the lowest dose of fenofibrate without
food effect. LCP-AtorFen is designed to be a once daily tablet offering
a powerful and safe treatment of high cholesterol levels, addressing
three primary cardiovascular risk factors: low density lipoprotein
cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and
triglycerides (TG).
220 patients has been enrolled in a Phase II double-blind, randomized,
active controlled study to compare LCP-AtorFen with Lipitor and Tricor
in patients with mixed dyslipidemia over 12 weeks followed by an
open-label extension study for one year.
5. LCP-Lerc is an oral formulation of lercanidipine, a
Calcium Channel Blocker (CCB) used in the treatment of hypertension. The
product is being developed in collaboration with Recordati as a
follow-on product to Zanidip/Lercadip. By applying LifeCycle Pharma’s
MeltDose technology to lercanidipine, thereby forming LCP-Lerc, the
intention is to increase bioavailability in order to reduce the dose
needed and the food effect so that patients can take the product without
regard to meals. LCP-Lerc has successfully completed Phase I. Assuming
progress as currently expected, an application for marketing
authorization (MAA) is expected to be submitted by Recordati in 2008.
6. LCP-Feno (containing 145 mg / 48 mg active substance)
is being developed as a potential AB-rated, substitutable version of
Tricor 145 mg and 48 mg, which is currently marketed in the US by Abbott
and in Europe by Solvay under the name Lipanthyl.
The AB rated product is defined by the FDA as therapeutically equivalent
to the branded one, meaning that is has the same expected clinical
effect and safety profile when given as defined in the product labelling.
LifeCycle Pharma has entered into collaboration with Sandoz for the US
market and with Mylan for the European market. Our partners are
currently considering when to initiate clinical studies for LCP-Feno.
Key Figures
The following key figures and financial ratios have been calculated in
accordance with the recommendations of the Association of Danish
Financial Analysts.
Key figures comply with the requirements under IFRS and the Danish
financial reporting requirements. All key figures and financial ratios
are in conformity with the current accounting policies. The figures have
been stated in thousands, except for the financial ratios.
Key Figures
9 Months ended 30 September Third Quarter 2007
2006 2007
2006 (Unaudited) DKK'000 DKK'000 DKK'000 DKK'000
Income Statement
Revenue
60,702
3,990
53,668
1,782
Research and development costs
(120,601)
(87,887)
(46,464)
(29,037)
Administrative expenses
(38,087)
(16,753)
(12,662)
(9,354)
Operating loss
(97,986)
(100,650)
(5,458)
(36,609)
Net financial income / (expenses)
10,068
(358)
3,221
(333)
Net loss for the period
(87,918)
(101,008)
(2,237)
(36,942)
Balance Sheet
Cash and cash equivalents
397,369
7,387
397,369
7,387
Total assets
448,184
51,418
448,184
51,418
Share capital
31,771
17,720
31,771
17,720
Total equity
393,176
(1,610)
393,176
(1,610)
Cash Flow Statement
Cash flow from operating activities
(69,191)
(83,380)
(26,231)
(26,811)
Cash flow from investing activities
(2,570)
(7,088)
(513)
(1,757)
Cash flow from financing activities
4,472
10,631
6,973
(459)
Cash and cash equivalents at period end
397,369
7,387
397,369
7,387
Financial Ratios (in DKK)
Basic and diluted EPS
(2.88)
(5.70)
(0.07)
(2.08)
Weighted average number of shares
30,573,731
17,719,381
30,800,894
17,719,816
Average number of employees (FTEs)
58
42
69
45
Assets/equity
1.14
(31.93)
1.14
(31.93)
Financial Review
LifeCycle Pharma publishes its financial statements in Danish Kroner
(DKK). Solely for the convenience of the reader, this Interim Report
contains a conversion of certain DKK amounts into Euro (EUR) at a
specified rate. These converted amounts should not be construed as
representations that the DKK amounts actually represent such EUR amounts
or could be converted into EUR at the rate indicated or at any other
rate.
Unless otherwise indicated, conversion herein of financial information
into EUR has been made using the Danish Central Bank’s
spot rate on 30 September 2007, which was EUR 1.00 = DKK 7.4544.
Revenues
In the third quarter of 2007, LifeCycle Pharma recognized DKK 53.7
million in revenues, generated under the company’s
collaboration agreements. Total revenues for the first nine months of
2007 amounts DKK 60.7 million compared to DKK 4.0 million in the same
period of 2006. Upon market approval of LCP-FenoChol by the FDA,
LifeCycle Pharma earned full right to the upfront milestone payment of
USD 5 million received from Sciele Pharma when signing the license
agreement. This approval was received in August 2007 and the USD 5
million was, together with an additional milestone payment of USD 4
million triggered by the approval, recognized as revenue in the third
quarter of 2007.
Research and Development Costs
Research and development costs were DKK 120.6 million for the first nine
months of 2007 compared to DKK 87.9 million for the same period 2006.
The higher research and development costs reflect the increased activity
in the company’s pipeline, primarily the
costs related to the clinical trials carried out, but also costs related
to the increased number of employees working within research and
development. Over the course of 2007, the number of employees working
within research and development has increased from 35 to 56.
Further, LifeCycle Pharma has established a subsidiary in the US to
monitor the clinical activities in the US and to maintain a close
contact to the US authorities and market. Currently, all our clinical
trials are being conducted in the US and Canada.
Administrative Expenses
Administrative expenses were DKK 38.1 million in the first nine months
of 2007 compared to DKK 16.8 million in the similar period of 2006. This
increase is attributable to the general strengthening of administrative
functions following the company’s IPO in
November 2006, leading to increased personnel expenses and warrant
compensation costs. Further, the company has established an investor
relation function and a subsidiary in the US.
Warrant Compensation Costs
During the first nine months of 2007, a total of DKK 13.6 million was
recognized as share-based compensation. DKK 4.7 million was recognized
for the third quarter. The comparable figures for 2006 were DKK 6.9
million for the first nine months, of which DKK 4.5 million were
recognized in the third quarter.
The warrant compensation costs for the first nine months of 2007 were
allocated to research and development costs at DKK 5.6 million and to
administrative expenses at DKK 8.0 million.
Operating Loss
LifeCycle Pharma’s operating loss for the
first nine months of 2007 was DKK 98.0 million compared to DKK 100.7
million in the corresponding period of 2006. The operating loss for the
third quarter was DKK 5.5 million compared to DKK 36.6 million in the
third quarter of 2006.
Financial Income
During the first nine months of 2007, the company recognized net
financial income of DKK 10.1 million compared to net financial expenses
of DKK 0.4 million in the first nine months of 2006. The increasing
financial income is a reflection of the interest on the net proceeds
from the company’s IPO in November 2006.
Net Loss
Net loss for the first nine months of 2007 was DKK 87.9 million compared
to DKK 101.0 million in the same period 2006.
Cash Flow
As of 30 September 2007, the balance sheet reflects cash and cash
equivalents of DKK 397.4 million compared to DKK 464.7 million as of 31
December 2006. This represents a decrease of DKK 67.3 million, primarily
related to the company’s operating activities
for the period.
The operating activities required cash flows of DKK 69.2 million
compared to DKK 83.4 million in the corresponding period of 2006. The
operating cash flow for the first nine months of 2007 is, however,
positively affected by the revenues which were significantly higher in
2007 compared to 2006.
Balance Sheet
As of 30 September 2007, total assets were DKK 448.2 million compared to
DKK 507.1 million at the end of 2006.
Shareholders’ equity equalled DKK 393.2
million as of 30 September 2007 compared to DKK 458.1 million at the end
of 2006.
The forward looking statements and targets contained herein are based on
LifeCycle Pharma A/S’s management’s
current view and assumptions. Such statements involve known and unknown
risks and uncertainties that may cause actual results, performance or
events to differ materially from those anticipated herein. LifeCycle
Pharma A/S expressly disclaim any obligation or undertaking to update or
revise any forward looking statements, targets or estimates contained in
this interim report to reflect any change in events, conditions,
assumptions or circulations on which any such statements are based
unless so required by applicable law.
Executive Management’s and the Board of
Directors’ Statement on the Interim Report
The Executive Management and the Board of Directors have today
considered and adopted the Interim Report of LifeCycle Pharma A/S for
the 9 months ended 30 September 2007.
The Interim Report is prepared in accordance with the Copenhagen Stock
Exchange’s financial reporting requirements
for listed companies. The Interim Report is in compliance with
International Accounting Standard No. 34 (IAS 34), "Interim
Financial Reporting” and additional Danish
disclosure requirements for financial reporting of listed companies.
We consider the applied accounting policies to be appropriate and, in
our opinion, the Interim Report gives a true and fair view of the assets
and liabilities, financial position, results of operation and cash flow
of the Group.
Horsholm, 27 November 2007
Executive Management
Flemming 0rnskov
Michael Wolff Jensen
Board of Directors
Claus Braestrup
Kurt Anker Nielsen
Thomas Dyrberg
(Chairman)
Jean Deleage
Gerard Soula
Income Statement
9 Months ended 30 September Third Quarter 9 Months ended 30 September Third Quarter 2007
2006 2007
2006 2007
2006 2007
2006 DKK'000 DKK'000 DKK'000 DKK'000 EUR'000 EUR'000 EUR'000 EUR'000
Revenue
60,702
3,990
53,668
1,782
8,143
535
7,200
239
Research and development costs
(120,601)
(87,887)
(46,464)
(29,037)
(16,178)
(11,790)
(6,233)
(3,895)
Administrative expenses
(38,087)
(16,753)
(12,662)
(9,354)
(5,109)
(2,247)
(1,699)
(1,255)
Operating loss (97,986) (100,650) (5,458) (36,609) (13,144) (13,502) (732) (4,911)
Financial income
14,018
764
5,421
128
1,881
102
727
17
Financial expenses
(3,950)
(1,122)
(2,200)
(461)
(531)
(150)
(295)
(62)
Loss before tax (87,918) (101,008) (2,237) (36,942) (11,794) (13,550) (300) (4,956)
Tax for the period
-
-
-
-
-
-
-
-
Net loss for the period (87,918) (101,008) (2,237) (36,942) (11,794) (13,550) (300) (4,956)
Basic and diluted EPS (in DKK / EUR)
(2.88)
(5.70)
(0.07)
(2.08)
(0.39)
(0.76)
(0.01)
(0.28)
Weighted average number of shares
30,573,731
17,719,381
30,800,894
17,719,816
30,573,731
17,719,381
30,800,894
17,719,816
Balance Sheet – Assets
30 September 31 December 30 September 30 September 31 December 30 September 2007 2006 2006 2007 2006 2006 DKK'000 DKK'000 DKK'000 EUR'000 EUR'000 EUR'000
Licenses and rights
742
779
792
100
105
106
Intangible assets 742 779 792 100 105 106
Property, plant and equipment
21,300
23,264
15,632
2,857
3,120
2,097
Leasehold improvements
5,288
5,848
6,068
709
785
814
Prepayments for property, plant and equipment
-
-
9,426
-
-
1,264
Property, plant and equipment 26,588 29,112 31,126 3,566 3,905 4,175 Non-current assets 27,330 29,891 31,918 3,666 4,010 4,281
Trade receivables
4,022
6,707
2,685
540
900
360
Other receivables
18,018
5,430
4,165
2,417
728
559
Prepayments
1,445
371
5,263
194
50
706
Receivables 23,485 12,508 12,113 3,151 1,678 1,625 Cash and cash equivalents 397,369 464,658 7,387 53,307 62,333 991 Current assets 420,854 477,166 19,500 56,458 64,011 2,616 Assets 448,184 507,057 51,418 60,124 68,021 6,897 Balance Sheet – Equity and
Liabilities
30 September 31 December 30 September 30 September 31 December 30 September 2007 2006 2006 2007 2006 2006 DKK'000 DKK'000 DKK'000 EUR'000 EUR'000 EUR'000
Share capital
31,771
30,370
17,720
4,262
4,074
2,377
Share premium
724,645
717,039
229,567
97,210
96,190
30,796
Other reserves
431
-
-
58
-
-
Retained earnings/loss
(363,671)
(289,326)
(248,897)
(48,786)
(38,813)
(33,389)
Equity 393,176 458,083 (1,610) 52,744 61,451 (216)
Finance lease
20,859
24,665
25,075
2,798
3,309
3,364
Non-current liabilities 20,859 24,665 25,075 2,798 3,309 3,364
Finance lease
5,352
6,081
5,956
718
816
799
Trade payables
17,720
11,957
17,738
2,377
1,604
2,380
Deferred revenue
-
373
746
-
50
100
Debt to shareholders
-
166
-
-
22
-
Other payables
11,077
5,732
3,513
1,487
769
470
Current liabilities 34,149 24,309 27,953 4,582 3,261 3,749
Liabilities 55,008 48,974 53,028 7,380 6,570 7,113
Equity and liabilities 448,184 507,057 51,418 60,124 68,021 6,897 Cash Flow Statement
9 months ended 30 September 9 months ended 30 September 2007
2006 2007
2006 DKK'000 DKK'000 EUR'000 EUR'000
Operating loss (97,986) (100,650) (13,144) (13,502)
Share-based payment
13,573
6,932
1,821
930
Depreciation and amortization
5,130
3,416
688
458
Changes in working capital
(138)
7,280
(19)
977
Cash flow from operating activities before interest (79,421) (83,022) (10,654) (11,137)
Interest received
13,245
764
1,777
102
Interest paid
(3,015)
(1,122)
(404)
(150)
Corporate tax paid
-
-
-
-
Cash flow from operating activities (69,191) (83,380) (9,281) (11,185)
Purchase of property, plant and equipment
(2,570)
(7,088)
(345)
(950)
Cash flow from investing activities (2,570) (7,088) (345) (950)
Proceeds from bank borrowings and finance lease
-
4,245
-
569
Installments on bank borrowings and finance lease
(4,535)
(3,539)
(608)
(475)
Proceeds from issuance of shares, net
9,007
9,925
1,208
1,331
Cash flow from financing activities 4,472 10,631 600 1,425
Increase/(decrease) in cash and cash equivalents (67,289) (79,837) (9,026) (10,710)
Cash and cash equivalents at beginning of period
464,658
87,224
62,333
11,701
Cash and cash equivalents at end of period 397,369 7,387 53,307 991
Cash and cash equivalents at end of period comprise:
Restricted bank deposit
1,443
-
194
-
Deposit on demand and cash
395,926
7,387
53,113
991
397,369 7,387 53,307 991 Statement of Changes in Equity
Number of shares Share capital Share premium Other reserves Retained earnings Total Total
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000 EUR'000
Equity as of 1 January 2006 4,428,569 4,429 242,822 0 (154,821) 92,430 12,399
Comprehensive income:
Net loss for the period
(101,008)
(101,008)
(13,550)
Total comprehensive income
(101,008)
(13,550)
Warrant exercises
1,385
1
42
43
6
Share-based payment
6,932
6,932
930
Bonus Shares
13,289,862
13,290
(13,290)
0
0
Costs related to capital increases
(7)
(7)
(1)
Equity as of 30 September 2006 17,719,816 17,720 229,567 0 (248,897) (1,610) (216)
Comprehensive income:
Net loss for the period
(46,705)
(46,705)
(6,265)
Total comprehensive income
(46,705)
(6,265)
Issuance of shares
12,650,000
12,650
543,950
556,600
74,667
Share-based payment
6,276
6,276
842
Costs related to capital increases
(56,478)
(56,478)
(7,577)
Equity as of 31 December 2006 30,369,816 30,370 717,039 0 (289,326) 458,083 61,451
Comprehensive income:
Net loss for the period
(87,918)
(87,918)
(11,794)
Total comprehensive income
(87,918)
(11,794)
Warrant exercises
1,400,889
1,401
7,663
9,064
1,216
Share-based payment
13,573
13,573
1,821
Costs related to capital increases
(57)
(57)
(8)
Exchange rate adjustment of investments in subsidiaries
431
431
58
Equity as of 30 September 2007 31,770,705 31,771 724,645 431 (363,671) 393,176 52,744
The share capital is not available for distribution, while other
reserves are distributable for dividend purposes subject to the
provision of the Danish Public Company Act.
Note 1. Accounting Policies
The interim report has been prepared in accordance with the Copenhagen
Stock Exchange’s financial reporting
requirements for listed companies. The interim report is in compliance
with International Accounting Standard No. 34 (IAS 34), "Interim
Financial Reporting”.
Effective from 1 January 2007, the group has adopted the new and amended
standards issued by the International Accounting Standards Board with
effective dates as of 1 January 2007. The adoption of these new and
amended standards has not affected the financial reporting of the group
for any periods presented in this interim report.
Except for the adoption of the new and amended standards issued by the
IASB, the accounting policies used for the interim report are consistent
with the accounting policies used in the company’s
latest annual report, which was prepared in accordance with the IFRS as
adopted by the EU and the additional Danish disclosure requirements for
financial reporting of listed companies.
The interim report has been prepared in Danish Kroner (DKK), which is
the functional currency of the company and the group.
Note 2. Warrants
LifeCycle Pharma has established warrant programs for board members,
members of executive management, employees, consultants and advisors.
All warrants have been issued by the company’s
shareholders or by the board of directors pursuant to valid
authorizations in LifeCycle Pharma’s articles
of association.
Vesting Conditions
Warrants issued during the period 2003 to 2005 vest in general at 1/36
per month from the date of grant. However, some warrants are not subject
to vesting conditions, but vest in full at the time of grant.
Effective from 2006, warrants generally vest at 1/48 per month from the
date of grant. However, some warrants are not subject to vesting
conditions but vest in full at the time of grant.
Warrants granted prior to 1 July 2004 cease to vest upon termination of
the employment relationship regardless of the reason for such
termination. Warrants granted after 1 July 2004 cease to vest from the
date of termination in the event that (i) a warrant
holder resigns without this being due to the company’s
breach of contract, or (ii) if LifeCycle Pharma terminates the
employment relationship where the employee has given the company good
reason to do so. The warrant holder will, however, be entitled to
exercise vested warrants in the first coming exercise period after
termination.
Exercise of warrants issued to board members, consultants and other
advisors are conditional upon the warrant holder being connected to
LifeCycle Pharma on the date of exercise. However, if the warrant holder’s
position has been terminated without this being attributable to the
warrant holder’s actions or omissions, the
warrant holder shall be entitled to exercise vested warrants in the
pre-determined exercise periods.
Exercise Periods
Vested warrants may generally be exercised during two three-week periods
following publication of LifeCycle Pharma’s
preliminary annual report and LifeCycle Pharma’s
interim report for the first six months of the relevant financial year,
respectively.
Adjustments
Warrant holders are entitled to an adjustment of the number of warrants
issued and/or the exercise price applicable in the event of certain
changes to LifeCycle Pharma’s share capital
at a price other than the market price and in the event of payments of
dividends in a given year in excess of 10% of the company’s
equity.
The number of warrants issued and the applicable exercise price was
adjusted on 27 July 2006 to take into account the issue of bonus shares
in the ratio 1:3, as resolved at the general meeting on 27 July 2006.
Please refer to LifeCycle Pharma’s latest
annual report for additional details of the company’s
warrant programs.
Warrant Activity
The following table specifies the warrant activity during the first nine
months of 2007:
Employees Executive management Board of directors Other external Total
Outstanding as of 1 January 2006 1,237,796 1,140,500 373,528 42,000 2,793,824
Granted in the period
572,000
1,564,757
-
8,000
2,144,757
Exercised in the period
(5,540)
-
-
-
(5,540)
Cancelled in the period
(26,460)
(211,250)
-
-
(237,710)
Outstanding as of 30 September 2006 1,777,796 2,494,007 373,528 50,000 4,695,331
Granted in the period
96,000
32,381
-
-
128,381
Change between categories
870,966
(650,966)
(323,528)
103,528
-
Outstanding as of 31 December 2006 2,744,762 1,875,422 50,000 153,528 4,823,712
Granted in the period
590,000
-
55,000
-
645,000
Exercised in the period
(718,077)
(654,580)
-
(28,232)
(1,400,889)
Cancelled in the period
(50,181)
-
-
-
(50,181)
Outstanding as of 30 September 2007 2,566,504 1,220,842 105,000 125,296 4,017,642
In total, as of 30 September 2007, a total of 4,017,642 warrants were
outstanding with a weighted average exercise price of DKK 34.24.
2,355,357 of these warrants had vested as of 30 September 2007. For
comparison, as of 30 September 2006, a total of 4,695,331 warrants were
outstanding with a weighted average exercise price of DKK 22.81.
Warrant Compensation Costs
Warrant compensation costs are calculated at the date of grant by use of
the Black-Scholes valuation model with the following assumptions: (i) a
volatility of 35%, determined as the average of the stock price
volatility for a group of Danish an European pharma and biotech
companies over 3 years; (ii) no payment of dividends; (iii) a risk free
interest rate equalling the interest rate on a 5-year government bond on
the date of grant; and (iv) a life of the warrants determined as the
average of the date of becoming exercisable and the date of expiry.
Warrant compensation costs are recognized in the income statement over
the vesting period of the warrants granted.
During the first nine months of 2007, a total of DKK 13.6 million was
recognized as share-based compensation, of which DKK 4.7 million was
recognized for the third quarter. The comparable figures for the first
nine months of 2006 were 6.9 million of which DKK 4.6 million was
recognized in the third quarter.
The warrant compensation costs for the first nine months of 2007 were
allocated to research and development costs at DKK 5.6 million and to
administrative expenses at DKK 8.0 million.
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