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LifeCycle Pharma Publishes Annual Report 2010

01-03-11 kl. 1/3 2011 16:20 | Veloxis Pharmaceuticals 0,90 (+4,65%)

Company Announcement no. 2/2011


To: NASDAQ OMX Copenhagen A/S
Hørsholm, Denmark, 1 March 2011




LifeCycle Pharma Publishes Annual Report 2010


LifeCycle Pharma A/S (OMX:LCP) (‘LCP') today published the annual report of
LifeCycle Pharma A/S for the financial year 2010. 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 2010 published separately today.


Full Year 2010 Highlights


-- Positive results of phase 2 clinical trial for LCP-Tacro™ in de novo kidney
transplant patients.


-- Received Special Protocol Assessment (SPA) from FDA for LCP-Tacro™ pivotal
phase 3 study in de novo kidney transplant patients.


-- First patient dosed in LCP-Tacro™ pivotal phase 3 study in de novo kidney
transplant patients.


-- Fully subscribed offering of 395,974,670 new shares of DKK 1 nominal value
each subscribed at DKK 1.20 per share.


-- Positive one-year top-line results of phase 2 clinical trial for
LCP-Tacro™ in de novo liver transplant patients.


-- During 2010, LCP recognized DKK 1.5 million in revenue compared to DKK 2.5
million in 2009. Revenue consists of payments under LCP's collaboration
agreements.


-- Research and development costs are in line with 2009 with DKK 210.1 million
in 2009 and DKK 210.4 million in 2010. Although total research and
development costs increased only slightly between the periods, the increase
in costs due to the increased research and development costs related to the
Phase 3 clinical study for LCP-Tacro in stable kidney transplant patients,
was almost completely offset by the decrease in costs due to the reduction
in the number of employees that took place in August 2009 and in January
2010.


-- Administrative expenses decreased by DKK 10.2 million or by 16.4%, from DKK
62.4 million in 2009 to DKK 52.2 million in 2010. The reduction in cost is
attributable to the continued focus of reducing overall cost, combined with
the effect of the reduction in the number of employees that took place in
August 2009 and January 2010.


-- One-off restructuring cost mainly includes salary payments to former
employees in connection with the reduction in the number of employees in
August 2009 and in January 2010.


-- During 2010, LCP recognized DKK 272.0 million in operating loss compared to
DKK 279.5 million in 2009, and DKK 274.2 million in net loss compared to
DKK 271.0 million in 2009. The net loss is in line with management's
expectations for 2010, which projected a net loss of DKK 260-290 million.


-- As per 31 December 2010, the balance sheet reflects cash and cash
equivalents of DKK 531.5 million compared to DKK 333.4 million as per 31
December 2009. The increase in cash position reflects the total net
proceeds from the Offering of approximately DKK 445 million, partially
offset by expenditures associated with LCP's business activities.



Conference Call

On 2 March, 2011, LCP's Management will host a conference call, at 4:00 PM CET
(Denmark); 3:00 PM GMT (London), 10:00 AM ET (New York), 7:00 AM PT (San
Francisco).


To access the live conference call, please dial one of the following numbers:

+45 32 72 76 25 Denmark

+44 (0) 1452 555 566 UK

+1 631 510 7498 USA

Access code 48073383


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

2010 2009 2008 2007 2006
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
--------------------------------------------------------------------------------

Income Statement
Revenue 1,496 2,476 170,122 64,705 9,740
Research and (210,426) (210,140) (270,875) (183,608) (129,403)
development costs
Administrative (52,198) (62,381) (73,311) (54,033) (29,395)
expenses
One-off (10,894) (9,489) - - -
restructuring cost
Operating loss (272,022) (279,534) (174,064) (172,936) (149,058)
Net financial income (759) 8,540 24,285 12,697 1,345
/ (expenses)
Loss before tax (272,781) (270,994) (149,779) (160,239) (147,713)
Tax for the period (1,425) - - - -
Net loss for the (274,206) (270,994) (149,779) (160,239) (147,713)
period
--------------------------------------------------------------------------------

Balance Sheet
Cash and cash 531,519 333,429 600,130 331,740 464,658
equivalents
Total assets 562,906 379,269 646,293 381,912 507,057
Share capital 452,543 56,568 56,288 31,771 30,370
Total equity 498,238 317,281 572,323 325,689 458,083
Investment in 2,583 11,043 6,571 5,900 7,222
property, plant and
equipment
--------------------------------------------------------------------------------

Cash Flow Statement
Cash flow from (238,148) (251,158) (102,560) (129,291) (125,813)
operating
activities
Cash flow from (2,658) (11,011) (6,628) (7,298) (7,222)
investing
activities
Cash flow from 440,014 729 373,637 3,769 510,469
financing
activities
Cash and cash 531,519 333,429 600,130 331,740 464,658
equivalents at
period end
--------------------------------------------------------------------------------

Financial Ratios
Basic and diluted (2.84) (4.80) (3.06) (5.19) (7.65)
EPS (DKK)
Weighted average 96,707,708 56,443,701 49,006,500 30,875,434 19,313,737
number of shares
Average number of 59 93 102 64 44
employees (FTEs)
Assets/equity 1.13 1.20 1.13 1.17 1.11
--------------------------------------------------------------------------------

Fourth Quarter 2010 Highlights


-- Research and development cost were realized at DKK 48.3 million compared to
DKK 45.7 million in same period in 2009, and DKK 66.2 million in the
previous quarter.


-- Administrative expenses were realized at DKK 13.4 million compared to DKK
14.7 million in same period in 2009, and DKK 12.8 million in the previous
quarter.


-- Operating loss amounted to DKK 61.7 million, while net loss was realized at
DKK 61.4 million.





Financ
ial
Highl
ights
Quarte
rly
Numbe
rs in
DKK
Q4 Q3 Q2 Q1 Q4 Q3
Q2 Q1
2010 2010 2010 2010 2009 2009
2009 2009
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
DKK'000 DKK'000
--------------------------------------------------------------------------------
----------------------
Income
State
ment
Revenu - 3 871 623 182 447
1,499 349
e
Resear (48,302) (66,150) (39,625) (56,349) (45,740) (43,986)
(57,604) (62,810)
ch and
devel
opment
costs
Admini (13,439) (12,829) (12,773) (13,157) (14,713) (14,330)
(16,357) (16,981)
strati
ve
expen
ses
One-of - - - (10,894) - (9,489)
- -
f
restr
ucturi
ng
cost
Operat (61,741) (78,976) (51,527) (79,777) (60,271) (67,358)
(72,462) (79,443)
ing
loss
Net 461 (695) (313) (212) 516 394
(2,105) 9,735
finan
cial
incom
e /
(expe
nses)
Loss (61,281) (79,671) (51,840) (79,989) (59,755) (66,964)
(74,567) (69,708)
befor
e tax
Tax (168) (862) (395) - - -
- -
for
the
perio
d
Net (61,448) (80,533) (52,235) (79,989) (59,755) (66,964)
(74,567) (69,708)
loss
for
the
perio
d
--------------------------------------------------------------------------------
----------------------
Balanc
e
Sheet
Cash 531,519 134,022 205,136 261,918 333,429 392,133
439,809 520,228
and
cash
equiv
alents
Total 562,906 163,651 245,345 302,353 379,269 444,915
500,455 574,148
asset
s
Share 452,543 56,568 56,568 56,568 56,568 56,568
56,439 56,439
capit
al
Total 498,238 111,902 189,958 240,383 317,281 373,583
436,727 507,712
equit
y
Invest
ment
in
prope
rty,
plant 1,548 441 101 493 489 890
7,149 2,515
and
equip
ment
--------------------------------------------------------------------------------
----------------------
Cash
Flow
State
ment
Cash (45,568) (67,109) (55,659) (69,812) (56,800) (44,714)
(71,872) (77,772)
flow
from
opera
ting
activ
ities
Cash (1,548) (281) (246) (583) (504) (843)
(7,064) (2,600)
flow
from
inves
ting
activ
ities
Cash 444,519 (2,059) (1,351) (1,095) (1,312) (446)
2,593 (105)
flow
from
finan
cing
activ
ities
Cash 531,519 134,022 205,136 261,918 333,429 392,133
439,809 520,228
and
cash
equiv
alents
at
perio
d end
--------------------------------------------------------------------------------
----------------------
Financ
ial
Ratio
s
Basic (0.64) (1.42) (0.92) (1.41) (1.06) (1.19)
(1.32) (1.24)
and
dilut
ed EPS
Weight 96,707,708 56,567,810 56,567,810 56,567,810 56,443,701 56,467,878
56,438,320 56,297,561
ed
avera
ge
numbe
r of
share
s
Averag 54 51 60 69 77 88
99 102
e
numbe
r of
emplo
yees
(FTEs
)
Assets 1.13 1.46 1.29 1.26 1.20 1.19
1.15 1.13
/equit
y
--------------------------------------------------------------------------------
----------------------
The quarterly
numbers have not
been audited.







Outlook for 2011

LCP is expecting an operating loss of DKK 250-280 million compared to the
realized operating loss of DKK 272.0 million in 2010. The net loss is likewise
expected to be in the range of DKK 250-280 million compared to the net loss of
DKK 274.2 million in 2010. As of 31 December 2010, the Company's cash position
equaled DKK 531.5 million and the Company's 31 December 2011 cash position is
expected to be in the range of DKK 250-300 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 exchange rates.



Important Events following the Balance Sheet Date

Following the balance sheet date no material events have occurred, and
consequently no material stock exchange announcements have been issued.



Grant of Warrants

At a Board meeting held on 1 March 2011, the Board of Directors decided to
issue 2,612,052 warrants to employees of LCP. Of the total number of warrants
granted, 1,260,052 was granted to the President & CEO William J. Polvino, and
752,000 was granted to SVP, Commercial Development and Strategic Planning, John
Weinberg.


By application of the Black-Scholes formula, the market value of the warrant
program can be calculated as DKK 0.55 per warrant assuming an exercise price of
DKK 1.23, equal to the closing price of LCP's share at the NASDAQ OMX
Copenhagen on 1 March 2011, based on an interest rate of 2.47 % and a
volatility of LCPs shares set to 55%.


The volatility is based on the Company's historical share prices since its IPO
in November 2006.



For more information, please contact:



LifeCycle Pharma A/S Johnny Stilou
John Weinberg, M.D. CFO
SVP, Commercial Development and Strategic Planning Phone: + 45 2055 3817
Phone: +1 732 321 3208 Email: [email protected]
Email: [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 Jersey, LCP is a specialty
pharmaceutical company. Clinical development is the core of LCP's efforts to
develop a product portfolio which includes the Company's lead product
candidate, LCP-Tacro™, for immunosuppression, specifically organ
transplantation, and products to combat certain cardiovascular diseases. 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 lipid-lowering product,
Fenoglide®, currently on the U.S. market and a diversified near and medium-term
pipeline with three clinical stage product candidates 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.




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