Company Announcement no. 2/2010
To: NASDAQ OMX Copenhagen Hørsholm, Denmark, 24 February 2010
LifeCycle Pharma Publishes Annual Report 2009
LifeCycle Pharma A/S (OMX:LCP) (‘LCP') today published the annual report of
LifeCycle Pharma A/S for the financial year 2009. The annual report has been
prepared in accordance with International Financial Reporting Standards as
adopted by the EU and additional Danish disclosure requirements for annual
reports of listed companies.
This company announcement should be read in conjunction with LCP's annual
report 2009 published separately today.
Full Year 2009 Highlights
• Submission of the Phase 3 protocol to the Food and Drug Administration in the
U.S. (FDA) for LCP-Tacro™ in de novo kidney transplant patients.
• Patent granted by the U.S. Patent and Trademark Office related to Fenoglide®.
• Dr. William Polvino was appointed President and Chief Executive Officer.
• During 2009, LCP recognized DKK 2.5 million in revenue compared to DKK 170.1
million in 2008. Revenue 2008 included up-front payment in connection with
sales of the future royalty stream from Fenoglide® in North America.
• Research and development costs decreased by DKK 60.8 million, or by 22%, from
DKK 270.9 million in 2008 to DKK 210.1 million in 2009. The reduced research
and development costs reflect the fluctuations in activity related to the
ongoing Phase 3 study regarding LCP-Tacro™ (kidney), along with cost reductions
in connection with the reduction in force that has taken place during the year.
Further we have reversed patent and enforcement provisions of DKK 10.5 million
as these obligations have been meet in connection with the grant of the patent
in the U.S. related to Fenoglide®.
• Administrative expenses decreased from DKK 73.3 million in 2008 to DKK 62.4
million in 2009. 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 year.
• During 2009, LCP recognized DKK 279.5 million in operating loss compared to
DKK 174.1 million in 2008, and DKK 271.0 million in net loss compared to DKK
149.8 million in 2008.
• As per 31 December 2009, the balance sheet reflects cash and cash equivalents
of DKK 333.4 million compared to DKK 600.1 million as per 31 December 2008. The
cash position was in connection with the Q3 2009 report announced on 11
November 2009 estimated to be in the range of DKK 300-330 million; the main
reason for the slight net increase compared to previous guidance relates to
timing of R&D expenses for LCP-Tacro™, which now are expected to incur in the
first half of 2010.
• For 2010, LCP projects an operating loss of DKK 260-290 million and a net
loss likewise in the range of DKK 260-290 million. At the end of 2010, LCP's
cash position is expected to be in the range of DKK 50-100 million.
Conference Call
On 25 February 2010, at 10:00 AM (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). Following the conference call,
a recording will be available on the company's website www.lcpharma.com. A
presentation will be available on LCP's website (under ‘Investors') one hour
prior to the scheduled time of the conference call.
Financial highlights
2009 2008 2007 2006 2005
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
Income Statement
Revenue 2,476 170,122 64,705 9,740 2,754
Research and development costs (210,140) (270,875) (183,608) (129,403) (80,919)
Administrative expenses (62,381) (73,311) (54,033) (29,395) (16,170)
One-off restructuring cost (9,489) - - - -
Operating loss (279,534) (174,064) (172,936) (149,058) (94,335)
Net financial income / (expenses) 8,540 24,285 12,697 1,345 (834)
Net loss for the year (270,994) (149,779) (160,239) (147,713) (95,169)
Balance Sheet
Cash and cash equivalents 333,429 600,130 331,740 464,658 87,224
Total assets 379,269 646,293 381,912 507,057 136,357
Share capital 56,568 56,288 31,771 30,370 4,429
Total equity 317,281 572,323 325,689 458,083 92,430
Investment in property, plant and equipment 489 6,571 5,900 7,222 13,572
Cash Flow Statement
Cash flow from operating
activities (251,158) (102,560) (129,291) (125,813) (86,771)
Cash flow from investing activities (11,011) (6,628) (7,298) (7,222) (13,572)
Cash flow from financing activities 729 373,637 3,769 510,469 187,558
Cash and cash equivalents at period end 333,429 600,130 331,740 464,658
87,224
Financial Ratios
Basic and diluted EPS (DKK) (4.80) (3.06) (5.19) (7.65) (6.81)
Weighted average number of shares 56,443,701 49,006,500 30,875,434
19,313,737 13,965,252
Average number of employees (FTEs) 93 102 64 44 35
Assets/equity 1.20 1.13 1.17 1.11 1.48
Fourth Quarter 2009 Highlights
• Revenue amounted to DKK 0.2 million compared to DKK 0.4 million in the
previous quarter
• Research and development cost were realized at DKK 45.7 million compared to
DKK 78.7 million in same period in 2008, and DKK 44.0 million in the previous
quarter
• Administrative expenses were realized at DKK 14.7 million compared to DKK
18.3 million in same period in 2008, and DKK 14.3 million in the previous
quarter
• Operating loss amounted to DKK 60.3 million, while net loss was realized at
DKK 59.8 million
Quarterly Numbers
Q4 Q3 Q2 Q1 Q4 Q3 Q2 Q1
2009 2009 2009 2009 2008 2008 2008 2008
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
Income Statement
Revenue 182 447 1,499 349 4,809 154,433 7,952 2,928
Research and development
costs (45,740) (43,986) (57,604) (62,810) (78,684) (69,738) (69,537) (52,916)
Administrative
expenses (14,713) (14,330) (16,357) (16,981) (18,286) (18,626) (18,854) (17,545)
One-off restructuring cost - (9,489) - - - - - -
Operating loss (60,271) (67,358) (72,462) (79,443) (92,161) 66,069
(80,439) (67,533)
Net financial income / (expenses) 516 394 (2,105) 9,735 11,507 5,150 5,305
2,323
Net loss for the period (59,755) (66,964) (74,567) (69,708) (80,654) 71,219
(75,134) (65,210)
Balance Sheet
Cash and cash equivalents 333,429 392,133 439,809 520,228 600,130 666,895
588,001 265,501
Total assets 379,269 444,915 500,455 574,148 646,293 708,915 634,100
311,892
Share capital 56,568 56,568 56,439 56,439 56,288 56,288 56,093 32,105
Total equity 317,281 373,583 436,727 507,712 572,323 648,456 571,863
266,277
Investment in property,
plant and equipment 489 890 7,149 2,515 6,571 1,205 3,207 801
Cash Flow Statement
Cash flow from operating
activities (56,800) (44,714) (71,872) (77,772) (68,616) 80,250
(48,362) (65,832)
Cash flow from investing
activities (504) (843) (7,064) (2,600) (1,415) (1,205) (3,207) (801)
Cash flow from financing activities (1,313) (446) 2,593 (105) (1,653) 463
373,930 897
Cash and cash equivalents at period end 333,429 392,133 439,809 520,228
600,130 666,895 588,001 265,501
Financial Ratios
Basic and diluted EPS (1.06) (1.19) (1.32) (1.24) (1.43) 1.27 (1.46) (2.05)
Weighted average number of shares 56,443,701 56,467,878 56,438,320
56,297,561 56,287,507 56,135,241 51,611,713 31,833,188
Average number of employees (FTEs) 77 88 99 102 107 113 101 93
Assets/equity 1.20 1.19 1.15 1.13 1.13 1.09 1.11 1.17
Outlook for 2010
LCP is projecting an operating loss of DKK 260-290 million compared to the
realized operating loss of DKK 279.5 million in 2009. The net loss is likewise
expected to be in the range of 260-290 million compared to the net loss of DKK
271.0 million in 2009. As of 31 December 2009, the Group's cash position
equaled DKK 333.4 million, and the Group's 31 December 2010 cash position is
expected to be in the range of DKK 50-100 million.
The above estimates are subject to possible changes primarily due to the timing
and variation of clinical activities, related costs, royalty and other partner
income, and fluctuating currency exchange rates.
Management continues to focus on securing sufficient funds for the operations
and expects to bring additional funds into the company in 2010 by either
partner agreements, debt or equity, or a mix thereof.
Important Events following the Balance Sheet Date
On 18 January 2010, LCP announced plans to refocus its organization to optimize
value creation. The organization will be strengthened in the areas of late
stage development and business development during the first half of 2010 with
up to 10 new employees. In parallel, LCP did at the end of January 2010 reduce
its organization by 26 employees in the area of CMC (Chemistry, Manufacturing
and Control) and in LCP's administrative functions.
Patent on LCP-TacroTM in Europe
In February 2010, LCP was 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.
Research and Development Update
LCP-Tacro™ Transplant
The clinical Phase 3 program in stable kidney transplant patients was initiated
in December 2008 and the planned patient enrollment was finalized early January
2010.
This program consists of a conversion (switch) study in which patients randomly
either stay on treatment with Prograf® or switch to LCP-Tacro™. This first
Phase 3 study includes patients at more than 53 centers in North America and 5
European countries. We expect to complete the Phase 3 study in stable kidney
patients in first quarter of 2011.
In December 2009, the protocol for LCP-Tacro™ in de novo kidney patients was
submitted to the FDA. We continue to expect to enroll the first patient for
this study around mid 2010.
As previously announces 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
is expected during H1 2010 for the kidney program and H2 for the liver program.
LCP-3301
A Phase 1 study was initiated in 2008, formulation activities continues and LCP
is assessing the commercial potential of the drug.
LCP-Feno
LCP has produced clinical supplies for a pivotal bioequivalence study and is
currently evaluating the timing and content of such a study aiming at
conducting the study later in 2010.
LCP-AtorFen
Results from a Phase 2 clinical one year extension study were released in May
2009 and confirmed the previous results achieved in 2008 in the initial Phase 2
program. An ‘end of Phase 2' meeting has been held with the FDA; a Phase 3
clinical study protocol has during 2009 been prepared accordingly, and drug
material for a clinical Phase 3 study has been prepared. LCP is currently in
active dialogue with several companies regarding a potential collaboration on
the clinical Phase 3 development as well as a licensing agreement for
commercialization of LCP-AtorFen.
Other preclinical projects
- Internal preclinical projects
LCP has worked on a number of initiatives to bring forward internal projects in
preclinical development by applying LCP's suite of technologies to these
compounds. LCP is currently advancing on such projects.
- Preclinical projects with external partners
LCP has a range of product formulation agreements with external partners in
regard to LCP's technology base, including the Meltdose® technology and also
the LLT (Liquid Loadable Tablet) technology.
LCP has a policy of announcing details of preclinical projects once these enter
clinical development.
Grant of Warrants
At a Board meeting held on 24 February 2010, the Board of Directors decided to
issue 588,000 warrants to employees of the Company and the Company's
subsidiary. Of the 588,000 warrants granted, 50,000 was granted to the EVP
Peter G. Nielsen.
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 24 February 2010, thus ensuring that the
exercise price reflects the fair market price per share following the
disclosure of the annual report 2009.
By application of the Black-Scholes formula, the market value of the warrant
program can be calculated as DKK 2.6 per warrant assuming an exercise price of
DKK 6.05, equal to the closing price of LCP's share at the NASDAQ OMX
Copenhagen on 24 February 2010, based on an interest rate of 2.72 % and a
volatility of LCPs shares set to 50%.
For more information, please contact:
LifeCycle Pharma A/S
Dr. William J. Polvino
President & Chief Executive Officer
Phone: +45 7033 3300
Email: WJP@lcpharma.com
or
Peter Schøtt Knudsen
Head of Investor Relations & General Counsel
Phone: + 45 2055 3817
Email: PSK@lcpharma.com
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. LCP adapts new technologies on a fast
commercial timetable. One of LCP's unique, patented delivery technologies,
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 one in
preclinical development. LCP is listed on NASDAQ OMX Copenhagen under the
trading symbol (OMX: LCP). For further information, please visit
www.lcpharma.com.
