Company Announcement no. 36/2008
To: OMX Nordic Exchange Copenhagen Hørsholm, Denmark, November 27, 2008
LifeCycle Pharma Announces Interim Report
For the 9 Months Ended September 30, 2008
LifeCycle Pharma has a strong financial position and prepares to enter clinical
Phase 3 for LCP-Tacro
LifeCycle Pharma A/S (OMX:LCP) reported a net loss of DKK 69.1 million for the
first nine months of 2008, compared to a net loss of DKK 87.9 million for the
same period in 2007. This is in line with the expectations for 2008 which were
announced in the Q2 2008 interim report of August 21, 2008.
For the first nine months of 2008 LCP recognized DKK 165.3 million in revenue
compared to DKK 60.7 million in the same period of 2007. Revenue mainly consists
of the USD 29 million (equivalent to DKK 152 million) up-front payment LCP
received from Cowen Healthcare Royalty Partners, L.P. in connection with the
sale of the future royalty stream from FenoglideTM in North America. Additional
revenue consists of payments under LCP's collaboration agreements.
For the first nine months of 2008, LCP's research and development costs amounted
to DKK 192.2 million compared to DKK 120.6 million during the same period in
2007. The higher research and development costs reflect increased activity in
the company's pipeline, primarily costs related to the clinical trials being
carried out, including Phase 2 clinical studies for LCP-Tacro (kidney and liver)
and LCP-AtorFen as well as preparations for Phase 3 clinical studies for both
product candidates.
On September 30, 2008, LCP had cash and cash equivalents of DKK 666.9 million.
During the third quarter of 2008, LCP continued the positive development from
the previous quarters of 2008 and achieved the following major business and
scientific milestones:
LCP announced positive top-line results from a completed Phase 2 clinical study
of LCP-Tacro tablets in stable liver transplant patients. Results are in line
with earlier data announced for stable kidney transplant patients and healthy
volunteer studies. These new data for LCP-Tacro, a once daily immunosuppressive
drug for the prevention of organ rejection following solid organ
transplantation, confirms the potentially best-in-class pharmacokinetic profile
of LCP-Tacro tablets when compared to the currently marketed twice daily
capsule formulation of tacrolimus, Prograf®
LCP announced that the royalty stream in North America related to its first
commercialized product, Fenoglide™, the cholesterol lowering drug (formerly
known as LCP-FenoChol) for the treatment of hyperlipidemia and
hypertriglyceridemia, has been sold to Cowen Healthcare Royalty Partners, L.P.
for a total payment of up to USD 105 million based on certain sales milestones
including an up-front payment of USD 29 million
Further LCP announced that Dr. Michael Beckert has decided to resign as EVP and
CMO of LCP in order to pursue other opportunities outside LCP effective December
31, 2008. Dr. Karin Hamberg, who is currently EVP of Drug Delivery Research and
Alliance & Project Management, will assume responsibility for Clinical,
Regulatory, and Medical Affairs undertaking Dr. Beckert's responsibilities.
Subsequent Events
On October 17, 2008, LCP announced that Dr. Jim New was appointed as President
and CEO with immediate effect. Dr. New is an internationally recognized senior
executive with extensive experience in global business development within the
pharmaceutical industry and was CEO of Abrika Pharmaceuticals. Dr. Jim New was
granted 500,000 warrants at a strike price of DKK 14.5. In addition, LCP
announced that Hans Christian Teisen has decided to resign as EVP and CFO of LCP
in order to take up a position as CFO and partner in PricewaterhouseCoopers,
Denmark, effective December 1, 2008. A search for a new CFO is ongoing.
Expectations for 2008
LCP retains its 2008 guidance with an operating loss of DKK 220 - 250 million
and a net loss of DKK 210 - 240 million.
As of December 31, 2007, the Company's cash position equaled DKK 331.7 million
and the Company's December 31, 2008 cash position is expected to be in the range
of DKK 500 - 540 million.
Research & Development Update
LCP-Tacro Transplant
After having demonstrated positive Phase 2 Pharmacokinetic (PK) data in stable
transplant patients earlier this year, LCP had successful discussions with the
U.S. Food and Drug Administration (FDA) regarding the further development of
LCP-Tacro once-daily tablets. The FDA acknowledged the Company's strategy of
submitting a §505(b)2 application for LCP-Tacro, thereby making use of existing
literature data to support the application for prevention of organ rejection in
kidney and liver transplant patients. To further support the safety database and
potentially best in class pharmacokinetic profile for LCP-Tacro, LCP agreed with
the FDA to perform PK-studies in de novo kidney and liver transplants. These
ongoing studies are expected to confirm the superior pharmacokinetic profile of
LCP-Tacro over existing tacrolimus formulations (Prograf®) in de novo transplant
patients, for which Phase3 pivotal clinical studies for liver and kidney are
expected to begin in 2009. As previously announced, LCP expects to initiate a
Phase 3 clinical study in approximately 300 stable kidney transplant patients in
the second half of 2008, converting patients from Prograf® twice-daily to
LCP-Tacro once-daily with a 30% reduced daily dosage. The pivotal clinical
program in liver patients awaits discussions with FDA in the first half of 2009.
LCP-Siro
Formulation activities with LCP-Siro are ongoing with the aim of testing the
product in Phase 1 clinical trials. Clinical Phase 1 data are expected to become
available in 2009.
LCP-3301
First clinical Phase 1 results have been received for LCP-3301. The clinical
data confirms the extended release profile of the product. Further optimization
of the formulation continues with the objective of selecting a final formulation
based on Phase 1 studies, planned to be conducted in 2009.
LCP-Tacro Autoimmune Hepatitis
The enrolment of patients in the ongoing Phase 2 trial for LCP-Tacro in
Autoimmune Hepatitis is behind the expected schedule as fewer patients than
expected are available for treatment by referral centers. Patients enrolled
continue in the trial while LCP is evaluating potential actions.
LCP-AtorFen
LCP recently presented positive Phase 2 data on LCP-AtorFen, its combination of
atorvastatin and low-dose fenofibrate for the treatment of mixed dyslipidemia,
at the 2008 American Heart Association Scientific Sessions. The open-label
extension study for one year of the Phase 2 program is ongoing, and results from
this study are expected in the first half of 2009.
Based on this positive outcome of Phase 2, LCP has initiated discussions with
the FDA to prepare for the pivotal Phase 3 development program. LCP is presently
exploring various strategies for LCP-AtorFen, aiming to find a partner in the
first half of 2009. Meanwhile LCP continues its preparations for the pivotal
Phase 3 program as planned.
LCP-AtorFen is targeted to address all three angles of the atherogenic triad,
decreasing significantly LDL-cholesterol (the “bad” cholesterol) and
triglycerides while increasing significantly HDL-cholesterol (the “good”
cholesterol).
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| Key Figures | | | | | |
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--------------------------------------------------------------------------------
| | | Q3 | Q3 | YTD | YTD | Year |
--------------------------------------------------------------------------------
| | | 2008 | 2007 | 2008 | 2007 | 2007 |
--------------------------------------------------------------------------------
| | | DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 |
--------------------------------------------------------------------------------
| | | | | | | |
--------------------------------------------------------------------------------
| Income Statement | | | | | |
--------------------------------------------------------------------------------
| Revenue | 154,433 | 53,668 | 165,313 | 60,702 | 64,705 |
--------------------------------------------------------------------------------
| Research and development | (69,738 | (46,464 | (192,19 | (120,60 | (183,60 |
| costs | ) | ) | 1) | 1) | 8) |
--------------------------------------------------------------------------------
| Administrative expenses | (18,626 | (12,662 | (55,025 | (38,087 | (54,033 |
| | ) | ) | ) | ) | ) |
--------------------------------------------------------------------------------
| Operating loss | 66,069 | (5,458) | (81,903 | (97,986 | (172,93 |
| | | | ) | ) | 6) |
--------------------------------------------------------------------------------
| Net financial income / | 5,150 | 3,221 | 12,778 | 10,068 | 12,697 |
| (expenses) | | | | | |
--------------------------------------------------------------------------------
| Net loss for the period | 71,219 | (2,237) | (69,125 | (87,918 | (160,23 |
| | | | ) | ) | 9) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Balance Sheet | | | | | |
--------------------------------------------------------------------------------
| Cash and cash equivalents | 666,895 | 397,369 | 666,895 | 397,369 | 331,740 |
--------------------------------------------------------------------------------
| Total assets | 708,915 | 448,184 | 708,915 | 448,184 | 381,912 |
--------------------------------------------------------------------------------
| Share capital | 56,288 | 31,771 | 56,288 | 31,771 | 31,771 |
--------------------------------------------------------------------------------
| Total equity | 648,456 | 393,176 | 648,456 | 393,176 | 325,689 |
--------------------------------------------------------------------------------
| Investment in property, | 1,205 | 513 | 5,212 | 2,570 | 5,900 |
| plant and equipment | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash Flow Statement | | | | | |
--------------------------------------------------------------------------------
| Cash flow from operating | 79,503 | (26,231 | (34,973 | (69,191 | (130,72 |
| activities | | ) | ) | ) | 7) |
--------------------------------------------------------------------------------
| Cash flow from investing | (1,205) | (1,851) | (5,212) | (3,908) | (7,298) |
| activities | | | | | |
--------------------------------------------------------------------------------
| Cash flow from financing | 463 | 6,972 | 375,290 | 4,472 | 3,769 |
| activities | | | | | |
--------------------------------------------------------------------------------
| Cash and cash equivalents | 666,895 | 397,369 | 666,895 | 397,369 | 331,740 |
| at period end | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Financial Ratios | | | | | |
--------------------------------------------------------------------------------
| Basic and diluted EPS | 1.27 | (0.07) | (1.48) | (2.88) | (5.19) |
--------------------------------------------------------------------------------
| Weighted average number of | 56,135, | 30,800, | 46,561, | 30,573, | 30,875, |
| shares | 241 | 894 | 782 | 731 | 434 |
--------------------------------------------------------------------------------
| Average number of | 113 | 69 | 105 | 58 | 64 |
| employees (FTEs) | | | | | |
--------------------------------------------------------------------------------
| Assets/equity | 1.09 | 1.14 | 1.09 | 1.14 | 1.17 |
--------------------------------------------------------------------------------
The interim report is unaudited.
Revenues
LCP recognized DKK 165.3 million in revenue compared to DKK 60.7 million during
the same period of 2007. Revenue mainly consists of the USD 29 million
(equivalent to DKK 152 million) up-front payment LCP received from Cowen
Healthcare Royalty Partners, L.P. in connection with sales of the future royalty
stream from FenoglideTM in North America. Additional revenue consists of
payments under LCP's collaboration agreements.
Research and Development Costs
For the first nine months of 2008, LCP's research and development costs amounted
to DKK 192.2 million compared to DKK 120.6 million during the same period in
2007. The higher research and development costs reflect increased activity in
the company's pipeline, primarily costs related to the clinical trials being
carried out, including Phase 2 clinical studies for LCP-Tacro (kidney and liver)
and LCP-AtorFen as well as preparations for Phase 3 clinical studies for both
product candidates.
Research and development costs in the third quarter of 2008 were realized at the
same level as the previous quarter with DKK 69.7 million compared to 69.5
million in the second quarter of 2008.
Administrative Expenses
Administrative expenses increased from DKK 38.1 million in the first nine months
of 2007 to DKK 55.0 million in the first nine months of 2008. This increase is
attributable to the general strengthening of administrative functions following
the company's IPO in November 2006, and the follow-on offering completed in
April 2008, along with the overall increase in activity.
Administrative expenses in the third quarter of 2008 were realized at the same
level as the previous quarter with DKK 18.6 million compared to 18.9 million in
the second quarter of 2008.
Share-based Compensation Costs
For the first nine months of 2008, a total of DKK 12.5 million were recognized
as share-based compensation. The comparable number for 2007 was DKK 13.6
million.
In the third quarter of 2008, a total of 80,000 warrants were granted to members
of the Executive Management at an average strike price of DKK 25.5, while other
employees were granted a total of 152,000 warrants at an average strike price of
DKK 25.5. Additionally up to 177,000 warrants were granted to a consultant at an
average strike price of DKK 25.5. In the third quarter of 2008, a total of
818,281 warrants have been cancelled, and a total of 194,563 warrants have been
exercised at an average exercise price of DKK 9.40.
As per September 30, 2008, there were a total of 5,220,779 warrants were
outstanding at an average strike price of DKK 28.5. Members of the Board of
Directors held 237,842 warrants at an average strike price of DKK 30.2. Members
of the Executive Management held 664,003 warrants at an average strike price of
DKK 30.2, while other current and former employees held 4,318,934 warrants at an
average strike price of DKK 28.1.
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 nine months of 2008 was DKK 81.9 million
compared to DKK 98.0 million in the corresponding period of 2007.
Financial Income
During the first nine months of 2008, the company recognized net financial
income of DKK 12.8 million compared to DKK 10.1 million in the first nine months
of 2007.
Net Loss
LCP's net loss for the first nine months of 2008 was DKK 69.1 million compared
to DKK 87.9 million in the corresponding period of 2007.
Cash Flow
As per September 30, 2008, the balance sheet reflects cash and cash equivalents
to DKK 666.9 million compared to DKK 331.7 million as per December 31, 2007. The
net increase reflects the proceeds from the follow-on offering in April 2008 and
the operating activities for the period, including the up-front payment from the
sale of the future royalty stream from FenoglideTM to Cowen Healthcare Royalty
Partners, L.P.
Balance Sheet
As per September 30, 2008, total assets were DKK 708.9 million compared to DKK
381.9 million at the end of 2007.
Shareholders' equity equalled DKK 648.5 million as of September 30, 2008,
compared to DKK 325.7 million at the end of 2007.
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 OMX Nordic Exchange Copenhagen's financial reporting requirements for listed
companies.
The accounting policies used for the interim report are consistent with the
accounting policies used in the company's latest annual report. The interim
report is unaudited.
Financial Review
LCP publishes 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 September
30, 2008, which was EUR 1.00 = DKK 7.4611.
Grant of Warrants
At a board meeting held on November 27, 2008, the Board of Directors decided to
issue 196,500 warrants to new employees of the Company and the Company's US
subsidiary.
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 OMX Nordic Exchange on November 27, 2008, thus ensuring that the
exercise price reflects the fair market price per share following the disclosure
of the interim report for the first nine months of 2008.
By application of the Black-Scholes formula, the market value of the warrant
program can be calculated as DKK 4.1 per warrant assuming an exercise price of
DKK 12.0, equal to the closing price of the Company's share at the OMX Nordic
Exchange on November 26, 2008, based on an interest rate of 3.98% and a
volatility of the Company's shares set to 35%.
Conference Call
On November 27, 2008, at 3.00 PM (CET), LCP will be hosting a conference call.
To access the call, please dial one of the following numbers: +1 866 966 5335
(US), +44 2030 032 666 (UK), +45 8088 8649 (DK). Subsequently, a recording will
be available on the company's website www.lcpharma.com.
Additional information: Jim New
President & CEO
Telephone +45 70 33 33 00
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 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 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, November 27, 2008
Executive Management
Jim New Hans Christian Teisen Peter G. Nielsen
President & CEO Executive Vice President & CFO Executive Vice President
Karin Jexner Hamberg Michael Beckert
Executive Vice President Executive Vice President
Board of Directors
Claus Braestrup Kurt Anker Nielsen Thomas Dyrberg
(Chairman)
Jean Deleage Gérard Soula Paul Edick
Anders Götzsche
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| Quarterly Numbers | | | | | | | | |
| in DKK | | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| | | Q3 | Q2 | Q1 | | Q4 | Q3 | Q2 | Q1 |
--------------------------------------------------------------------------------
| | | 2008 | 2008 | 2008 | | 2007 | 2007 | 2007 | 2007 |
--------------------------------------------------------------------------------
| | | DKK' | DKK' | DKK'0 | | DKK'0 | DKK'0 | DKK'0 | DKK'0 |
| | | 000 | 000 | 00 | | 00 | 00 | 00 | 00 |
--------------------------------------------------------------------------------
| | | | | | | | | | |
--------------------------------------------------------------------------------
| Income Statement | | | | | | | | |
--------------------------------------------------------------------------------
| Revenue | 154, | 7,95 | 2,928 | | 4,003 | 53,66 | 3,245 | 3,789 |
| | 433 | 2 | | | | 8 | | |
--------------------------------------------------------------------------------
| Research and | (69, | (69, | (52,9 | | (63,0 | (46,4 | (42,0 | (32,0 |
| development costs | 738) | 537) | 16) | | 07) | 64) | 41) | 96) |
--------------------------------------------------------------------------------
| Administrative | (18, | (18, | (17,5 | | (15,9 | (12,6 | (15,0 | (10,4 |
| expenses | 626) | 854) | 45) | | 46) | 62) | 25) | 00) |
--------------------------------------------------------------------------------
| Operating loss | 66,0 | (80, | (67,5 | | (74,9 | (5,45 | (53,8 | (38,7 |
| | 69 | 439) | 33) | | 50) | 8) | 21) | 07) |
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| Net financial | 5,15 | 5,30 | 2,323 | | 2,630 | 3,221 | 3,241 | 3,605 |
| income / | 0 | 5 | | | | | | |
| (expenses) | | | | | | | | |
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| Net loss for the | 71,2 | (75, | (65,2 | | (72,3 | (2,23 | (50,5 | (35,1 |
| period | 19 | 134) | 10) | | 20) | 7) | 80) | 02) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Balance Sheet | | | | | | | | |
--------------------------------------------------------------------------------
| Cash and cash | 666, | 588, | 265,5 | | 331,7 | 397,3 | 417,1 | 432,5 |
| equivalents | 895 | 001 | 01 | | 40 | 69 | 41 | 68 |
--------------------------------------------------------------------------------
| Total assets | 708, | 634, | 311,8 | | 381,9 | 448,1 | 464,5 | 475,8 |
| | 915 | 100 | 92 | | 12 | 84 | 71 | 29 |
--------------------------------------------------------------------------------
| Share capital | 56,2 | 56,0 | 32,10 | | 31,77 | 31,77 | 30,51 | 30,51 |
| | 88 | 93 | 5 | | 1 | 1 | 4 | 4 |
--------------------------------------------------------------------------------
| Total equity | 648, | 571, | 266,2 | | 325,6 | 393,1 | 381,7 | 427,8 |
| | 456 | 863 | 77 | | 89 | 76 | 58 | 04 |
--------------------------------------------------------------------------------
| Investment in | 1,20 | 3,20 | 801 | | 5,900 | 513 | 1,917 | 140 |
| property, plant | 5 | 7 | | | | | | |
| and equipment | | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash Flow | | | | | | | | |
| Statement | | | | | | | | |
--------------------------------------------------------------------------------
| Cash flow from | 79,5 | (48, | (66,2 | | (61,5 | (26,2 | (11,8 | (31,0 |
| operating | 03 | 231) | 44) | | 36) | 31) | 69) | 91) |
| activities | | | | | | | | |
--------------------------------------------------------------------------------
| Cash flow from | (1,2 | (3,2 | (801) | | (3,28 | (513) | (3,36 | (140) |
| investing | 05) | 07) | | | 5) | | 0) | |
| activities | | | | | | | | |
--------------------------------------------------------------------------------
| Cash flow from | 463 | 373, | 897 | | (703) | 6,973 | (1,64 | (859) |
| financing | | 930 | | | | | 2) | |
| activities | | | | | | | | |
--------------------------------------------------------------------------------
| Cash and cash | 666, | 588, | 265,5 | | 331,7 | 397,3 | 417,1 | 432,5 |
| equivalents at | 895 | 001 | 01 | | 40 | 69 | 41 | 68 |
| period end | | | | | | | | |
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--------------------------------------------------------------------------------
| Financial Ratios | | | | | | | | |
--------------------------------------------------------------------------------
| Basic and diluted | 1.27 | (1.4 | (2.05 | | (2.28 | (0.07 | (1.66 | (1.15 |
| EPS | | 6) | ) | | ) | ) | ) | ) |
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| Weighted average | 56,1 | 51,6 | 31,83 | | 31,77 | 30,80 | 30,51 | 30,40 |
| number of shares | 35,2 | 11,7 | 3,188 | | 0,705 | 0,894 | 4,048 | 1,868 |
| | 41 | 13 | | | | | | |
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| Average number of | 113 | 101 | 93 | | 64 | 69 | 59 | 45 |
| employees (FTEs) | | | | | | | | |
--------------------------------------------------------------------------------
| Assets/equity | 1.09 | 1.11 | 1.17 | | 1.17 | 1.14 | 1.22 | 1.11 |
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| Quarterly Numbers | | | | | | | | |
| in Euro | | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| | | Q3 | Q2 | Q1 | | Q4 | Q3 | Q2 | Q1 |
--------------------------------------------------------------------------------
| | | 2008 | 2008 | 2008 | | 2007 | 2007 | 2007 | 2007 |
--------------------------------------------------------------------------------
| | | EUR' | EUR' | EUR'0 | | EUR'0 | EUR'0 | EUR'0 | EUR'0 |
| | | 000 | 000 | 00 | | 00 | 00 | 00 | 00 |
--------------------------------------------------------------------------------
| | | | | | | | | | |
--------------------------------------------------------------------------------
| Income Statement | | | | | | | | |
--------------------------------------------------------------------------------
| Revenue | 20,6 | 1,06 | 392 | | 537 | 7,193 | 435 | 508 |
| | 98 | 6 | | | | | | |
--------------------------------------------------------------------------------
| Research and | (9,3 | (9,3 | (7,09 | | (8,44 | (6,22 | (5,63 | (4,30 |
| development costs | 47) | 20) | 2) | | 5) | 7) | 5) | 2) |
--------------------------------------------------------------------------------
| Administrative | (2,4 | (2,5 | (2,35 | | (2,13 | (1,69 | (2,01 | (1,39 |
| expenses | 96) | 27) | 2) | | 7) | 7) | 4) | 4) |
--------------------------------------------------------------------------------
| Operating loss | 8,85 | (10, | (9,05 | | (10,0 | (732) | (7,21 | (5,18 |
| | 5 | 781) | 1) | | 45) | | 4) | 8) |
--------------------------------------------------------------------------------
| Net financial | 690 | 711 | 311 | | 352 | 432 | 434 | 483 |
| income / | | | | | | | | |
| (expenses) | | | | | | | | |
--------------------------------------------------------------------------------
| Net loss for the | 9,54 | (10, | (8,74 | | (9,69 | (300) | (6,77 | (4,70 |
| period | 5 | 070) | 0) | | 3) | | 9) | 5) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Balance Sheet | | | | | | | | |
--------------------------------------------------------------------------------
| Cash and cash | 89,3 | 78,8 | 35,58 | | 44,46 | 53,25 | 55,90 | 57,97 |
| equivalents | 83 | 09 | 5 | | 3 | 9 | 9 | 6 |
--------------------------------------------------------------------------------
| Total assets | 95,0 | 84,9 | 41,80 | | 51,18 | 60,06 | 62,26 | 63,77 |
| | 15 | 87 | 2 | | 7 | 9 | 6 | 5 |
--------------------------------------------------------------------------------
| Share capital | 7,54 | 7,51 | 4,303 | | 4,258 | 4,258 | 4,090 | 4,090 |
| | 4 | 8 | | | | | | |
--------------------------------------------------------------------------------
| Total equity | 86,9 | 76,6 | 35,68 | | 43,65 | 52,69 | 51,16 | 57,33 |
| | 12 | 46 | 9 | | 2 | 7 | 6 | 8 |
--------------------------------------------------------------------------------
| Investment in | 161 | 430 | 107 | | 791 | 69 | 257 | 19 |
| property, plant | | | | | | | | |
| and equipment | | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash Flow | | | | | | | | |
| Statement | | | | | | | | |
--------------------------------------------------------------------------------
| Cash flow from | 10,6 | (6,4 | (8,87 | | (8,24 | (3,51 | (1,59 | (4,16 |
| operating | 56 | 64) | 9) | | 8) | 6) | 1) | 7) |
| activities | | | | | | | | |
--------------------------------------------------------------------------------
| Cash flow from | (161 | (430 | (107) | | (440) | (69) | (450) | (19) |
| investing | ) | ) | | | | | | |
| activities | | | | | | | | |
--------------------------------------------------------------------------------
| Cash flow from | 62 | 50,1 | 120 | | (94) | 935 | (220) | (115) |
| financing | | 17 | | | | | | |
| activities | | | | | | | | |
--------------------------------------------------------------------------------
| Cash and cash | 89,3 | 78,8 | 35,58 | | 44,46 | 53,25 | 55,90 | 57,97 |
| equivalents at | 83 | 09 | 5 | | 3 | 9 | 9 | 6 |
| period end | | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Financial Ratios | | | | | | | | |
--------------------------------------------------------------------------------
| Basic and diluted | 0.17 | (0.2 | (0.27 | | (0.31 | (0.01 | (0.22 | (0.15 |
| EPS | | 0) | ) | | ) | ) | ) | ) |
--------------------------------------------------------------------------------
| Weighted average | 56,1 | 51,6 | 31,83 | | 31,77 | 30,80 | 30,51 | 30,40 |
| number of shares | 35,2 | 11,7 | 3,188 | | 0,705 | 0,894 | 4,048 | 1,868 |
| | 41 | 13 | | | | | | |
--------------------------------------------------------------------------------
| Average number of | 113 | 101 | 93 | | 64 | 69 | 59 | 45 |
| employees (FTEs) | | | | | | | | |
--------------------------------------------------------------------------------
| Assets/equity | 1.09 | 1.11 | 1.17 | | 1.17 | 1.14 | 1.22 | 1.11 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Income Statement | | | Consolid | | |
| | | | ated | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| (DKK'000) | Q3 | Q3 | YTD | YTD | Year |
--------------------------------------------------------------------------------
| | | 2008 | 2007 | 2008 | 2007 | 2007 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Revenue | 154,433 | 53,668 | 165,313 | 60,702 | 64,705 |
--------------------------------------------------------------------------------
| Research and | (69,738) | (46,464) | (192,191 | (120,601 | (183,608 |
| development costs | | | ) | ) | ) |
--------------------------------------------------------------------------------
| Administrative | (18,626) | (12,662) | (55,025) | (38,087) | (54,033) |
| expenses | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Operating loss | 66,069 | (5,458) | (81,903) | (97,986) | (172,936 |
| | | | | | ) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Financial income | 7,714 | 5,421 | 18,422 | 14,018 | 18,553 |
--------------------------------------------------------------------------------
| Financial expenses | (2,564) | (2,200) | (5,644) | (3,950) | (5,856) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Loss before tax | 71,219 | (2,237) | (69,125) | (87,918) | (160,239 |
| | | | | | ) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Tax for the period | - | - | - | - | - |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Net loss for the | 71,219 | (2,237) | (69,125) | (87,918) | (160,239 |
| period | | | | | ) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Basic and diluted EPS | 1.27 | (0.07) | (1.48) | (2.88) | (5.19) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Weighted average | 56,135,2 | 30,800,8 | 46,561,7 | 30,573,7 | 30,875,4 |
| number of shares | 41 | 94 | 82 | 31 | 34 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Assets | | | | Consolid | | |
| | | | | ated | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| (DKK'000) | | Sep. 30 | | Sep. 30 | | Dec. 31 |
--------------------------------------------------------------------------------
| | | | 2008 | | 2007 | | 2007 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Licenses and rights | | 692 | | 742 | | 729 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Intangible assets | | 692 | | 742 | | 729 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Property, plant and equipment | | 21,420 | | 21,300 | | 21,837 |
--------------------------------------------------------------------------------
| Leasehold improvements | | 5,395 | | 5,288 | | 6,220 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Property, plant and equipment | | 26,815 | | 26,588 | | 28,057 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Non-current assets | | 27,507 | | 27,330 | | 28,786 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Trade receivables | | 6,854 | | 4,022 | | 3,842 |
--------------------------------------------------------------------------------
| Other receivables | | 6,722 | | 18,018 | | 14,379 |
--------------------------------------------------------------------------------
| Prepayments | | 937 | | 1,445 | | 3,165 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Receivables | | 14,513 | | 23,485 | | 21,386 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash and cash equivalents | | 666,895 | | 397,369 | | 331,740 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Current assets | | 681,408 | | 420,854 | | 353,126 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Assets | | 708,915 | | 448,184 | | 381,912 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Equity & Liabilities | | | | Consolid | | |
| | | | | ated | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| (DKK'000) | | Sep. 30 | | Sep. 30 | | Dec. 31 |
--------------------------------------------------------------------------------
| | | | 2008 | | 2007 | | 2007 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Share capital | | 56,288 | | 31,771 | | 31,771 |
--------------------------------------------------------------------------------
| Share premium | | 1,079,2 | | 724,645 | | 724,645 |
| | | 14 | | | | |
--------------------------------------------------------------------------------
| Translation reserves | | 1,162 | | 431 | | 821 |
--------------------------------------------------------------------------------
| Retained earnings/loss | | (488,20 | | (363,671 | | (431,548 |
| | | 8) | | ) | | ) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Equity | | 648,456 | | 393,176 | | 325,689 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Provisions | | 10,492 | | - | | - |
--------------------------------------------------------------------------------
| Finance lease | | 17,094 | | 20,859 | | 20,416 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Non-current liabilities | | 27,586 | | 20,859 | | 20,416 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Finance lease | | 4,619 | | 5,352 | | 5,092 |
--------------------------------------------------------------------------------
| Trade payables | | 13,669 | | 17,720 | | 15,066 |
--------------------------------------------------------------------------------
| Deferred revenue | | - | | - | | 1,716 |
--------------------------------------------------------------------------------
| Other payables | | 14,585 | | 11,077 | | 13,933 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Current liabilities | | 32,873 | | 34,149 | | 35,807 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Liabilities | | 60,459 | | 55,008 | | 56,223 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Equity and liabilities | | 708,915 | | 448,184 | | 381,912 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash Flow Statement | | | Consolid | | |
| | | | ated | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| (DKK'000) | Q3 | Q3 | YTD | YTD | Year |
--------------------------------------------------------------------------------
| | | 2008 | 2007 | 2008 | 2007 | 2007 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Operating loss | 66,069 | (5,458 | (81,902) | (97,986 | (172,93 |
| | | ) | | ) | 6) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Share-based payment | 3,905 | 4,715 | 12,465 | 13,573 | 18,017 |
--------------------------------------------------------------------------------
| Depreciation and | 2,283 | 1,804 | 6,497 | 5,130 | 7,004 |
| amortization | | | | | |
--------------------------------------------------------------------------------
| Net loss on sale of fixed | - | - | - | - | 60 |
| assets | | | | | |
--------------------------------------------------------------------------------
| Changes in working capital | 2,187 | (31,12 | 15,392 | (138) | 3,558 |
| | | 1) | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash flow from operating | 74,444 | (30,06 | (47,548) | (79,421 | (144,29 |
| activities before interest | | 0) | | ) | 7) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Interest received | 7,649 | 5,095 | 18,146 | 13,245 | 17,914 |
--------------------------------------------------------------------------------
| Interest paid | (2,590 | (1,266 | (5,571) | (3,015) | (4,344) |
| | ) | ) | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash flow from operating | 79,503 | (26,23 | (34,973) | (69,191 | (130,72 |
| activities | | 1) | | ) | 7) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Purchase of property, plant | (1,205 | (513) | (5,212) | (2,570) | (5,900) |
| and equipment | ) | | | | |
--------------------------------------------------------------------------------
| Net loss on sale of | - | - | - | - | (60) |
| property, plant and | | | | | |
| equipment | | | | | |
--------------------------------------------------------------------------------
| Cash transfer to restricted | - | (1,338 | - | (1,338) | (1,338) |
| security deposit | | ) | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash flow from investing | (1,205 | (1,851 | (5,212) | (3,908) | (7,298) |
| activities | ) | ) | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Proceeds from bank | - | - | - | - | 1,118 |
| borrowings and finance | | | | | |
| lease | | | | | |
--------------------------------------------------------------------------------
| Installments on bank | (1,281 | (1,535 | (3,795) | (4,535) | (6,356) |
| borrowings and finance | ) | ) | | | |
| lease | | | | | |
--------------------------------------------------------------------------------
| Proceeds from issuance of | 1,744 | 8,507 | 379,085 | 9,007 | 9,007 |
| shares, net | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash flow from financing | 463 | 6,972 | 375,290 | 4,472 | 3,769 |
| activities | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Increase/(decrease) in cash | 78,762 | (21,11 | 335,105 | (68,627 | (134,25 |
| and cash equivalents | | 0) | | ) | 6) |
--------------------------------------------------------------------------------
| Cash and cash equivalents | 586,74 | 417,14 | 330,402 | 464,658 | 464,658 |
| at beginning of period | 6 | 1 | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash and cash equivalents | 665,50 | 396,03 | 665,507 | 396,031 | 330,402 |
| at end of period | 7 | 1 | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Cash and cash equivalents | | | | | |
| at end of period comprise: | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Restricted bank deposit | 1,388 | 1,338 | 1,388 | 1,338 | 1,338 |
--------------------------------------------------------------------------------
| Deposit on demand and cash | 665,50 | 396,03 | 665,507 | 396,031 | 330,402 |
| | 7 | 1 | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| | | 666,89 | 397,36 | 666,895 | 397,369 | 331,740 |
| | | 5 | 9 | | | |
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--------------------------------------------------------------------------------
| Consolidated | | | | | | | |
| Equity | | | | | | | |
--------------------------------------------------------------------------------
| | | Number of | Share | Share | Transl | Retain | Total |
| | | Shares | Capita | Premiu | ation | ed | |
| | | | l | m | Reserv | Earnin | |
| | | | | | es | gs | |
--------------------------------------------------------------------------------
| | | | | DKK'00 | DKK'00 | DKK'00 | DKK'00 | DKK'00 |
| | | | | 0 | 0 | 0 | 0 | 0 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Equity as of 1 | 30,369 | | 30,370 | 717,03 | - | (289,3 | 458,08 |
| January 2007 | ,816 | | | 9 | | 26) | 3 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Comprehensive | | | | | | | |
| income: | | | | | | | |
--------------------------------------------------------------------------------
| | Net loss for | | | | | | (87,91 | (87,91 |
| | the period | | | | | | 8) | 8) |
--------------------------------------------------------------------------------
| | Exchange rate | | | | | | | |
| | adjustment of | | | | | | | |
--------------------------------------------------------------------------------
| | investments | | | | | 431 | | 431 |
| | in | | | | | | | |
| | subsidiaries | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Total | | | | | | | (87,48 |
| comprehensive | | | | | | | 7) |
| income | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Warrant exercises | 1,400, | | 1,401 | 7,663 | | | 9,064 |
| | 889 | | | | | | |
--------------------------------------------------------------------------------
| Share-based | | | | | | 13,573 | 13,573 |
| payment | | | | | | | |
--------------------------------------------------------------------------------
| Costs related to | | | | (57) | | | (57) |
| capital increases | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Equity as of | 31,770 | | 31,771 | 724,64 | 431 | (363,6 | 393,17 |
| September 30, 2007 | ,705 | | | 5 | | 71) | 6 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| | Net loss for | | | | | | (72,32 | (72,32 |
| | the period | | | | | | 1) | 1) |
--------------------------------------------------------------------------------
| | Exchange rate | | | | | | | |
| | adjustment of | | | | | | | |
--------------------------------------------------------------------------------
| | investments | | | | | 390 | | 390 |
| | in | | | | | | | |
| | subsidiaries | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Total | | | | | | | (71,93 |
| comprehensive | | | | | | | 1) |
| income | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Share-based | | | | | | 4,444 | 4,444 |
| payment | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Equity as of | 31,770 | | 31,771 | 724,64 | 821 | (431,5 | 325,68 |
| December 31, 2007 | ,705 | | | 5 | | 48) | 9 |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Comprehensive | | | | | | | |
| income: | | | | | | | |
--------------------------------------------------------------------------------
| | Net loss for | | | | | | (69,12 | (69,12 |
| | the period | | | | | | 5) | 5) |
--------------------------------------------------------------------------------
| | Exchange rate | | | | | | | |
| | adjustment of | | | | | | | |
--------------------------------------------------------------------------------
| | investments | | | | | 341 | | 341 |
| | in | | | | | | | |
| | subsidiaries | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Total | | | | | | | (68,78 |
| comprehensive | | | | | | | 4) |
| income | | | | | | | |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Issuance of shares | 24,322 | | 24,322 | 385,73 | | | 410,05 |
| | ,240 | | | 1 | | | 3 |
--------------------------------------------------------------------------------
| Warrant exercises | 194,56 | | 195 | 1,633 | | | 1,828 |
| | 2 | | | | | | |
--------------------------------------------------------------------------------
| Share-based | | | | | | 12,465 | 12,465 |
| payment | | | | | | | |
--------------------------------------------------------------------------------
| Costs related to | | | | (32,79 | | | (32,79 |
| capital increases | | | | 5) | | | 5) |
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
| Equity as of | 56,287 | | 56,288 | 1,079, | 1,162 | (488,2 | 648,45 |
| September 30, 2008 | ,507 | | | 214 | | 08) | 6 |
--------------------------------------------------------------------------------
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.
LifeCycle Pharma Announces Interim Report For the 9 Months Ended September 30, 2008
| Source: Veloxis Pharmaceuticals A/S
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