LifeCycle Pharma announces result for the first quarter 2010 and maintains its outlook for 2010.
12-05-10 kl. 12/5 2010 15:00 | Veloxis Pharmaceuticals 0,90 (+4,65%)
Company Announcement no. 8/2010
To: NASDAQ OMX Copenhagen Hørsholm, Denmark, 12 May, 2010
LifeCycle Pharma announces result for the first quarter 2010
and maintains its outlook for 2010.
LifeCycle Pharma A/S (OMX:LCP) today announced the Interim Report for the 3
months ended 31 March, 2010.
Highlights:
? LCP has been granted its first European patent relating to LCP-TacroTM. The
European patent relates to the pharmaceutical composition and oral dosage form
comprising tacrolimus in a vehicle mixture of polyethylene glycol and a
poloxamer. The patent is the first patent ever granted to LCP in Europe and
also the first patent granted for LCP-TacroTM in a major market. LCP has also
LCP-TacroTM product patents in China and India.
? In 2009 and in the first quarter of 2010 LCP has focused its organization to
optimize value creation. The organization is being strengthened in the areas of
late stage drug development and business development during 2010 with up 10 new
employees.
? LCP reported a net loss of DKK 80.0 million for the first quarter of 2010,
which included one-off restructuring costs related to salary payments to former
employees in connection with the reduction in force in January 2010. In the
same period in 2009 the net loss was DKK 69.7 million. The reported net loss is
in line with the expectations for 2010 which were announced in the annual
report for 2009 published on 24 February, 2010.
? For the first quarter of 2010, LCP's research and development costs amounted
to DKK 56.3 million compared to DKK 62.8 million during the same period in
2009.
? For the first quarter of 2010, LCP's had a net financial expense of DKK 0.2
million compared to an income of DKK 9.7 million in the same period in 2009.
The decrease in financial income is a reflection of lower earned interest on a
declining cash position during the period and currency loss related to the
increased DKK/USD rate.
? On 31 March, 2010, LCP had cash and cash equivalents of DKK 261.9 million.
A conference call will be held today, 12 May, 2010 at 5:30 PM CET (Denmark).
Please refer to page 7 for further details.
Outlook for 2010
LCP maintains its 2010 outlook with an operating loss of DKK 260-290 million
and likewise a net loss of DKK 260-290 million.
As of 31 December, 2009, the Company's cash position equaled DKK 333.4 million
and the Company's 31 December, 2010 cash position is expected to be in the
range of DKK 50-100 million.
Research & development update
LCP-Tacro? in kidney patients
The clinical Phase 3 program in stable kidney transplant patients was initiated
in December 2008. The patient enrollment was finalized early January 2010 with
326 patients. The clinical trial is progressing according to plan, and the
patients are now all enrolled in a 52 (excluding a 4 week follow-up period)
week trial. We expect as previously announced to complete the treatment in
stable kidney patients in first quarter of 2011.
As previously announced we submitted the protocol for LCP-Tacro? in de novo
kidney patients to the United States Food and Drug Administration (FDA) in
December 2009. We have had a constructive dialogue and submitted the protocol
for a Special Protocol Assessment in late March 2010 and expect to have a
feedback on the design of the Phase 3 protocol this quarter, and still expect
to enroll the first patient for this trial around the mid 2010.
The phase 2 PK clinical studies in de novo kidney and liver transplant patients
were successfully completed in April 2009 for de novo kidney patients and in
August 2009 for de novo liver patients. Both studies will have a one year
extension phase and the results from the extension phases are still expected
during this quarter for the kidney program and Q3 2010 for the liver program.
Legal update
On 28 April 2010, Shionogi Pharma, Inc. and LCP jointly filed in the US
District Court for the district of Delaware, a patent infringement lawsuit
against Impax Laboratories Ltd. (Impax) in response to their Abbreviated New
Drug Application (ANDA) for a proposed generic Fenoglide® (fenofibrate) 40 and
120 milligram tablets. Impax has generic versions approved in the United
States of higher doses of fenofibrate products (200 mg capsules and 160 mg
tablets). In their ANDA, Impax requests approval to sell generic Fenoglide®
tablets following the approval by the FDA. Shionogi and LCP's lawsuit asserts
that Impax, if permitted to market generic Fenoglide® tablets following a
potential approval of the ANDA, will infringe LCP's patent covering Fenoglide®
(patent number US 7,658,944 which expires in 2024) and requests that the Court
enter an injunction barring the sale of the Impax ANDA product until the
expiration of the LCP patent. The trial in the US District Court has not yet
been scheduled.
Key Figures
Q1 Q1 Year
2010 2009 2009
DKK'000 DKK'000 DKK'000
Income Statement
Revenue 623 349 2,476
Research and development costs (56,349) (62,810) (210,140)
Administrative expenses (13,157) (16,982) (62,381)
One-off restructuring cost (10,894) - (9,489)
Operating loss (79,777) (79,443) (279,534)
Net financial income / (expenses) (212) 9,735 8,540
Net loss for the period (79,989) (69,708) (270,994)
Balance Sheet
Cash and cash equivalents 261,918 520,228 333,429
Total assets 302,353 574,148 379,269
Share capital 56,568 56,439 56,568
Total equity 240,383 507,712 317,281
Investment in property, plant and equipment 493 2,515 11,043
Cash Flow Statement
Cash flow from operating activities (69,812) (77,772) (251,158)
Cash flow from investing activities (583) (2,600) (11,011)
Cash flow from financing activities (1,095) (105) 729
Cash and cash equivalents at period end 261,918 520,228 333,429
Financial Ratios
Basic and diluted EPS (1.41) (1.24) (4.80)
Weighted average number of shares 56,567,810 56,297,561 56,443,701
Average number of employees (FTEs) 69 102 93
Assets/equity 1.26 1.13 1.20
The interim report is unaudited.
Revenue
For the first quarter of 2010 LCP recognized DKK 0.6 million in revenues
compared to DKK 0.3 million in the same period of 2009. Revenue consists of
payments under LCP's collaboration agreements.
Research and development costs
For the first quarter of 2010, LCP's research and development costs amounted to
DKK 56.3 million compared to DKK 62.8 million during the same period in 2009.
The decrease is mainly due to fluctuations in activity in connection with the
ongoing Phase 3 trial for LCP-TacroTM (Stable kidney transplant patients).
Administrative expenses
For the first quarter of 2010, LCP's administrative cost amounted to DKK 13.2
million compared to DKK 17.0 million during the same period in 2009 and DKK
14.7 million in the previous quarter. The reduction in cost is attributable to
the continued focus of reducing overall cost, combined with the effect of the
reduction in force that has taken place during the past 9 months.
One-off restructuring cost
One-off restructuring cost includes provisions for salary payments to former
employees in connection with the reduction in January 2010.
Compensation costs
For the first three months of 2010, a total of DKK 3.1 million was recognized
as share-based compensation. The cost is included in R&D and G&A. The
comparable cost for 2009 was DKK 3.8 million.
In the first quarter of 2010, a total of 50,000 warrants were granted to a
member of the Executive Management at a strike price of DKK 6.05, while other
employees were granted a total of 538,000 warrants at a strike price of DKK
6.05. In the first quarter of 2010, a total of 499,929 warrants have been
cancelled.
As of 31 March, 2010, there were a total of 4,625,676 warrants outstanding at
an average strike price of DKK 18.2. Members of the Board of Directors held
350,667 warrants at an average strike price of DKK 21.8. Members of the
Executive Management held 807,572 warrants at an average strike price of DKK
12.8, while other current and former employees held 3,467,437 warrants at an
average strike price of DKK 19.1.
Please refer to LCP's latest annual report for additional details on the
Company's warrant programs.
Operating loss
LCP's operating loss for the first three months of 2010 was DKK 79.8 million
compared to DKK 79.4 million in the corresponding period of 2009.
Financial income
During the first three months of 2010, the Company recognized net financial
expenses of DKK 0.2 million compared to an income of DKK 9.7 million in the
first three months of 2009. The decrease in financial income is a reflection of
lower earned interest on a declining cash position during the period and
currency loss related to the increased DKK/USD rate.
Net loss
LCP's net loss for the first three months of 2010 was DKK 80.0 million compared
to DKK 69.7 million in the corresponding period of 2009.
Cash flow
As per 31 March, 2010, the balance sheet reflects cash and cash equivalents to
DKK 261.9 million compared to DKK 333.4 million as per 31 December, 2009. This
represents a decrease of DKK 71.5 million primarily related to the Company's
operating activities for the period.
Balance sheet
As per 31 March, 2010, total assets were DKK 302.4 million compared to DKK
379.3 million at the end of 2009.
Shareholders' equity equalled DKK 240.4 million as of 31 March, 2010, compared
to DKK 317.3 million at the end of 2009.
Accounting policies
The interim report is prepared in compliance with International Accounting
Standard No. 34 (IAS 34), "Interim Financial Reporting? and in accordance with
the NASDAQ OMX Copenhagen's financial reporting requirements for listed
companies.
There have been no changes in accounting policies used for the interim report
compared to the accounting policies used in the preparation of LifeCycle Pharma
group's annual report for 2009.
The line "one-off restructuring cost? includes major restructuring costs,
mainly salary to former employees and is shown separately to facilitate the
comparability of income statement and to provide a better picture of the
operational result.
Financial review
LCP reports its financial statements in Danish Kroner (DKK), which is the
functional currency of the Company and the group. 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 31 March,
2010, which was EUR 1.00 = DKK 7.4447.
Grant of warrants
At a board meeting held on 12 May, 2010, the Board of Directors decided to
issue 150,000 warrants to employees of the LCP. Of the total granted warrants,
Tim Melkus, Senior Vice President, Development Operations was granted 100,000
warrants.
Each warrant entitles the holder to subscribe one share of nominal DKK 1 in the
Company against cash contribution equal to the closing price of the Company's
shares at the NASDAQ OMX Copenhagen on 13 May, 2010, thus ensuring that the
exercise price reflects the fair market price per share following the
disclosure of the interim report for the first three months of 2010.
By application of the Black-Scholes formula, the market value of the warrant
program can be calculated as DKK 2.0 per warrant assuming an exercise price of
DKK 4.87, equal to the closing price of the Company's share at the NASDAQ OMX
Copenhagen on 11 May, 2010, based on an interest rate of 2.22% and a volatility
of the Company's shares set to 49%.
The volatility is based on the Company's historical share prices since its IPO
in November 2006.
Conference Call
Today, 12 May, 2010, LCP's Management will host a conference call, at 5:30 PM
CET (Denmark); 4:30 PM GMT (London), 11:30 AM ET (New York), 8:30 AM PT (San
Francisco).
To access the live conference call, please dial one of the following numbers:
+45 32 71 47 75 Denmark Toll
+1 212 444 0481 USA Toll
+44 (0)20 7136 2051 UK Toll
An audio replay of the conference call will be available on www.lcpharma.com
from tomorrow Thursday, 13 May, 2010 at 18:00 PM CET (Denmark); 17:00 PM GMT
(London), 12:00 PM ET (New York), 9:00 AM PT (San Francisco), through Friday,
11 June, 2010 by dialing +45 32 71 09 13 (DK), +44 (0) 20 7111 1244 (UK) or +1
347 366 9565 (US), and entering access code 2534991#.
Additional information:
Dr. William J. Polvino Peter Schøtt Knudsen
President and CEO General Counsel and Head of Investor Relations
+1 (917) 647 9107 +45 20 55 38 17
[email protected] [email protected]
The forward looking statements and targets contained herein are based on
LifeCycle Pharma A/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 required by applicable law.
About LifeCycle Pharma A/S (LCP)
Based in Hørsholm, Denmark, with an office in New York, LCP is an emerging
specialty pharmaceutical company. Clinical development is the core of LCP's
effort to develop a product portfolio which includes products for
immunosuppression, specifically organ transplantation, and products to combat
certain cardiovascular diseases. As a fully integrated company, LCP adapts new
technologies on a fast commercial timetable. LCP's unique, patented delivery
technology, MeltDose®, can improve absorption and bioavailability - at
low-scale up costs - not only for a broad spectrum of drugs already on the
market but also for new chemical entities. LCP has a cholesterol-lowering
product, Fenoglide?, currently on the U.S. market and a diversified near- and
medium-term pipeline with four product candidates in clinical trials and a
number of projects in preclinical development. LCP is listed on the NASDAQ OMX
Copenhagen under the trading symbol (OMX: LCP). For further information, please
visit www.lcpharma.com.
Executive Management's and the Board of Directors' Statement on the Interim
Report
The Executive Management and the Board of Directors have considered and adopted
the Interim Report of LifeCycle Pharma A/S.
The Interim Report is prepared in accordance 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 the operation and cash flow of the
group for the period under review. Furthermore, in our opinion the management
review includes a fair review of the development and performance of the
business and the financial position of the group, together with a description
of the material risks and uncertainties the group faces. The group does not
face any material risks or uncertainties relating to the financial statements.
Hørsholm, 12 May, 2010
Executive Management
Dr. William J. Polvino Peter G. Nielsen
President and CEO Executive Vice President
Board of Directors
Paul Edick Thomas Dyrberg Kurt Anker Nielsen
(Chairman) (Deputy Chairman)
Jean Deleage Gérard Soula Anders Götzsche
Mette Kirstine Agger
Quarterly Numbers in DKK
Q1 Q4 Q3 Q2 Q1
2010 2009 2009 2009 2009
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
Income Statement
Revenue 623 182 447 1,499 349
Research and development costs (56,349) (45,740) (43,986) (57,604) (62,810)
Administrative expenses (13,157) (14,713) (14,330) (16,357) (16,981)
One-off restructuring cost (10,894) - (9,489) - -
Operating loss (79,777) (60,271) (67,358) (72,462) (79,443)
Net financial income / (expenses) (212) 516 394 (2,105) 9,735
Net loss for the period (79,989) (59,755) (66,964) (74,567) (69,708)
Balance Sheet
Cash and cash equivalents 261,918 333,429 392,133 439,809 520,228
Total assets 302,353 379,269 444,915 500,455 574,148
Share capital 56,568 56,568 56,568 56,439 56,439
Total equity 240,383 317,281 373,583 436,727 507,712
Investment in property, plant and equipment 493 489 890 7,149 2,515
Cash Flow Statement
Cash flow from operating activities (69,812)
(56,800) (44,714) (71,872) (77,772)
Cash flow from investing activities (583) (504) (843) (7,064) (2,600)
Cash flow from financing activities (1,095) (1,312) (446) 2,593 (105)
Cash and cash equivalents at period end 261,918 333,429 392,133 439,809
520,228
Financial Ratios
Basic and diluted EPS (1.41) (1.06) (1.19) (1.32) (1.24)
Weighted average number of shares 56,567,810 56,443,701 56,467,878
56,438,320 56,297,561
Average number of employees (FTEs) 69 77 88 99 102
Assets/equity 1.26 1.20 1.19 1.15 1.13
Quarterly Numbers in Euro
Q1 Q4 Q3 Q2 Q1
2010 2009 2009 2009 2009
EUR'000 EUR'000 EUR'000 EUR'000 EUR'000
Income Statement
Revenue 84 24 60 201 47
Research and development costs (7,569) (6,144) (5,908) (7,738) (8,437)
Administrative expenses (1,767) (1,976) (1,925) (2,196) (2,281)
One-off restructuring cost (1,463) - (1,275) - -
Operating loss (10,715) (8,096) (9,048) (9,733) (10,671)
Net financial income / (expenses) (29) 69 53 (283) 1,308
Net loss for the period (10,744) (8,027) (8,995) (10,016) (9,363)
Balance Sheet
Cash and cash equivalents 35,182 44,787 52,673 59,077 69,879
Total assets 40,613 50,945 59,763 67,223 77,122
Share capital 7,598 7,598 7,598 7,581 7,581
Total equity 32,289 42,618 50,181 58,663 68,198
Investment in property, plant and equipment 66 66 120 960 338
Cash Flow Statement
Cash flow from operating activities (9,377) (7,630) (6,006) (9,654) (10,447)
Cash flow from investing activities (78) (68) (113) (949) (349)
Cash flow from financing activities (147) (176) (60) 348 (14)
Cash and cash equivalents at period end 35,182 44,787 52,673 59,077
69,879
Financial Ratios
Basic and diluted EPS (0.19) (0.14) (0.16) (0.18) (0.17)
Weighted average number of shares 56,567,810 56,443,701 56,467,878
56,438,320 56,297,561
Average number of employees (FTEs) 69 77 88 99 102
Assets/equity 1.26 1.20 1.19 1.15 1.13
Income Statement Consolidated
(DKK'000) Q1 Q1 Year
2010 2009 2009
Revenue 623 349 2,476
Research and development costs (56,349) (62,810) (210,140)
Administrative expenses (13,157) (16,982) (62,381)
One-off restructuring cost (10,894) - (9,489)
Operating loss (79,777) (79,443) (279,534)
Financial income 699 15,213 21,391
Financial expenses (911) (5,478) (12,851)
Loss before tax (79,989) (69,708) (270,994)
Tax for the period - - -
Net loss for the period (79,989) (69,708) (270,994)
Basic and diluted EPS (1.41) (1.24) (4.80)
Weighted average number of shares 56,567,810 56,297,561 56,443,701
Statements of comprehensive income Consolidated
(DKK'000) Q1 Q1 Year
2010 2009 2009
Net loss for the period (79,989) (69,708) (270,994)
Other comprehensive income:
Currency translation differences 12 305 215
Other comprehensive income for the period 12 305 215
Total comprehensive income for the period (79,977) (69,403) (270,779)
Assets Consolidated
(DKK'000) 31 Mar. 31 Mar. 31 Dec.
2010 2009 2009
Patent rights and software 836 667 860
Intangible assets 836 667 860
Property, plant and equipment 17,074 21,165 18,753
Leasehold improvements 7,218 4,939 7,506
Property, plant and equipment 24,292 26,104 26,259
Non-current assets 25,128 26,771 27,119
Trade receivables 303 3,240 302
Other receivables 6,206 5,164 4,390
Prepayments 8,798 18,745 14,029
Receivables 15,307 27,149 18,721
Cash and cash equivalents 261,918 520,228 333,429
Current assets 277,225 547,377 352,150
Assets 302,353 574,148 379,269
Equity & Liabilities Consolidated
(DKK'000) 31 Mar. 31 Mar. 31 Dec.
2010 2009 2009
Share capital 56,568 56,439 56,568
Share premium 1,080,263 1,079,554 1,080,263
Translation reserves 1,970 2,048 1,958
Retained earnings/loss (898,418) (630,329) (821,508)
Equity 240,383 507,712 317,281
Provisions - 10,492 -
Finance lease 12,755 14,955 14,091
Non-current liabilities 12,755 25,447 14,091
Finance lease 5,628 4,507 5,387
Trade payables 12,832 11,178 19,794
Deferred revenue - - 120
Other payables 30,755 25,304 22,596
Current liabilities 49,215 40,989 47,897
Liabilities 61,970 66,436 61,988
Equity and liabilities 302,353 574,148 379,269
Cash Flow Statement Consolidated
(DKK'000) Q1 Q1 Year
2010 2009 2009
Operating loss (79,777) (79,443) (279,534)
Share-based payment 3,079 3,827 13,934
Depreciation and amortization 2,493 2,297 10,455
Changes in working capital 4,057 (16,147) (3,188)
Cash flow from operating activities before interest (70,148) (89,466) (258,333)
Interest received 612 17,155 8,366
Interest paid (276) (5,461) (1,191)
Cash flow from operating activities (69,812) (77,772) (251,158)
Purchase of property, plant and equipment (493) (2,515) (11,043)
Cash transfer to restricted security deposit (90) (85) 32
Cash flow from investing activities (583) (2,600) (11,011)
Installments on bank borrowings and finance lease (1,095) (1,070) (1,055)
Proceeds from issuance of shares, net - 965 1,784
Cash flow from financing activities (1,095) (105) 729
Increase/(decrease) in cash and cash equivalents (71,490) (80,477) (261,440)
Cash and cash equivalents at beginning of period 332,066 598,735 598,735
Exchange gains/(losses) on cash and cash equivalent (110) 491 (5,229)
Cash and cash equivalents at end of period 260,466 518,749 332,066
Cash and cash equivalents at end of period comprise:
Restricted bank deposit 1,452 1,479 1,363
Deposit on demand and cash 260,466 518,749 332,066
261,918 520,228 333,429
Consolidated Equity
Number of Shares Share Capital Share Premium Translation
Reserves Retained Earnings Total
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
Equity as of 1 January 2009 56,287,507 56,288 1,078,740 1,743
(564,448) 572,323
Total comprehensive income 305 (69,708) (69,403)
Warrant exercises 150,813 151 814 965
Share-based payment 3,827 3,827
Equity as of 31 March 2009 56,438,320 56,439 1,079,554 2,048
(630,329) 507,712
Total comprehensive income (90) (201,286) (201,376)
Warrant exercises 129,490 129 709 838
Share-based payment 10,107 10,107
Equity as of 31 December 2009 56,567,810 56,568 1,080,263 1,958
(821,508) 317,281
Total comprehensive income 12 (79,989) (79,977)
Share-based payment 3,079 3,079
Equity as of 31 March 2010 56,567,810 56,568 1,080,263 1,970
(898,418) 240,383
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.
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