Company Announcement no. 6/2011


To: NASDAQ OMX Copenhagen A/S
Hørsholm, Denmark, 10 May, 2011



LifeCycle Pharma announces result for the first quarter 2011

and confirms second quarter 2011 timing for Phase 3 results



Highlights:


-- On target for release of phase 3 top line data in June 2011 for LCP-Tacro™
in kidney transplant patients (stable patients, Study 3001).

-- LCP reported a net loss of DKK 65.8 million for the first quarter of 2011
compared to a net loss of DKK 80.0 million for the same period in 2010. The
reported net loss is in line with the expectations for 2011, which were
announced in the annual report for 2010, published on 1 March 2011.

-- For the first quarter of 2011, LCP's research and development costs
amounted to DKK 52.3 million compared to DKK 56.3 million during the same
period in 2010.

-- On 31 March, 2011, LCP had cash and cash equivalents of DKK 462.3 million.

Outlook for 2011

LCP maintains its 2011 outlook with an operating loss of DKK 250-280 million
and likewise a net loss of DKK 250-280 million. The Company's position of cash
and cash equivalents as at 31 December, 2011 is expected to be in the range of
DKK 250-300 million.


Research & development update

LCP-Tacro™ in kidney transplant patients (stable patients, Study 3001)


The clinical Phase 3 program in stable kidney transplant patients was initiated
in December 2008, and full patient enrollment was finalized early January 2010
with 326 patients. The primary endpoint for the study is a non-inferiority
comparison of LCP-Tacro™ to Prograf® with the traditional composite endpoint
of: Biopsy Proven Acute Rejection (“BPAR”), graft failure, loss to follow up or
death. Secondary endpoints include assessments of safety/tolerability measures
and renal function. Patients were evaluated on treatment every few months over
a 12-month treatment duration plus a safety follow-up visit at month 13.


The clinical trial is progressing according to plan, and all patients have
completed their treatment. LCP expects to announce topline results of this key
study in June 2011.





LCP-Tacro™ in kidney transplant patients (de novo patients, Study 3002)


The clinical Phase 3 program in de novo kidney transplant patients was
initiated in October 2010. Patient enrollment is ongoing, and will include
approximately 540 patients in total.


The study is expected to be ready for filing in the U.S. and EU in the first
quarter of 2013.


The LCP Study 3002 is a randomized, double-blind, multicenter study that will
compare once-daily LCP-Tacro™ against twice-daily Prograf® in de novo adult
kidney transplant patients. The primary endpoint of the study, a composite
endpoint (BPAR, graft failure, loss to follow up or death), will be evaluated
after a 12-month treatment period to demonstrate the non-inferiority of
LCP-Tacro™ compared to Prograf®. Secondary endpoints will include safety,
tolerability and renal function assessments. The study will be conducted at
approximately 100 transplant centers, primarily in the U.S and Europe. Patients
will participate in a 12-month extension period on treatment for follow-up
safety assessments.







Financial Highlights

Q1 Q1 Year
2011 2010 2010
DKK'000 DKK'000 DKK'000
--------------------------------------------------------------------------------

Income Statement
Revenue - 623 1,496
Research and development costs (52,261) (56,349) (210,426)
Administrative expenses (11,724) (13,157) (52,198)
One-off restructuring cost - (10,894) (10,894)
Operating loss (63,985) (79,777) (272,022)
Net financial income / (expenses) (1,850) (212) (759)
Loss before tax (65,835) (79,989) (272,781)
Tax for the period - - (1,425)
Net loss for the period (65,835) (79,989) (274,206)
--------------------------------------------------------------------------------

Balance Sheet
Cash and cash equivalents 462,319 261,918 531,519
Total assets 490,578 302,353 562,906
Share capital 452,543 56,568 452,543
Total equity 436,200 240,383 498,238
Investment in property, plant and equipment 621 493 2,583
--------------------------------------------------------------------------------

Cash Flow Statement
Cash flow from operating activities (65,396) (69,812) (238,148)
Cash flow from investing activities (299,602) (583) (2,658)
Cash flow from financing activities (1,407) (1,095) 440,014
Cash and cash equivalents at period end 462,319 261,918 531,519
--------------------------------------------------------------------------------

Financial Ratios
Basic and diluted EPS (0.15) (1.41) (2.84)
Weighted average number of shares 452,542,480 56,567,810 96,707,708
Average number of employees (FTEs) 54 69 59
Assets/equity 1.12 1.26 1.13
--------------------------------------------------------------------------------


The interim report is unaudited.



Revenue

For the first quarter of 2011 LCP had no revenue compared to DKK 0.6 million in
revenues in the same period of 2010. Revenue in 2010 consisted of payments
under LCP's collaboration agreements.


Research and development costs

For the first quarter of 2011, LCP's research and development costs amounted to
DKK 52.3 million compared to DKK 56.3 million during the same period in 2010.
Research and development costs are mainly attributable to the two ongoing phase
3 trials in LCP-Tacro™. In the period cost is included to the finalization of
the phase 3 study in kidney transplant patients (stable patients, Study 3001),
along with costs associated to the ramp up in the phase 3 study in kidney
transplant patients (de novo patients, Study 3002).


Administrative expenses

For the first quarter of 2011, LCP's administrative cost amounted to DKK 11.7
million compared to DKK 13.2 million during the same period in 2010 and DKK
13.4 million in the previous quarter. The reduction in cost reflects the cost
reduction initiatives which have taken place during 2010.


One-off restructuring cost

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


Compensation costs

For the first three months of 2011, a total of DKK 3.5 million was recognized
as share-based compensation. The cost is included in R&D and G&A. The
comparable cost for 2010 was DKK 3.1 million.


In the first quarter of 2011, a total of 1,260,052 warrants were granted to a
member of the Executive Management at a strike price of DKK 1.23, while other
employees were granted a total of 1,352,000 warrants at a strike price of DKK
1.23. In the first quarter of 2011, a total of 1,675,278 warrants have been
cancelled.


As of 31 March, 2011, there were a total of 28,511,698 warrants outstanding at
an average strike price of DKK 3.2. Members of the Board of Directors held
578,976 warrants at an average strike price of DKK 9.8. Members of the
Executive Management held 8,788,122 warrants at an average strike price of DKK
2.2, while other current and former employees held 19,144,600 warrants at an
average strike price of DKK 3.5.


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 2011 was DKK 64.0 million
compared to DKK 79.8 million in the corresponding period of 2010.


Financial income

During the first three months of 2011, the Company recognized net financial
expenses of DKK 1.9 million compared to net financial expenses of DKK 0.2
million in the first three months of 2010. The loss is mainly due to currency
losses following the decline in the USD / DKK currency rate.



Net loss

LCP's net loss for the first three months of 2011 was DKK 65.8 million compared
to DKK 80.0 million in the corresponding period of 2010.


Cash flow

As per 31 March, 2011, the balance sheet reflects cash and cash equivalents to
DKK 462.3 million compared to DKK 531.5 million as per 31 December, 2010. This
represents a decrease of DKK 69.2 million primarily related to the Company's
operating activities for the period.


Balance sheet

As per 31 March, 2011, total assets were DKK 490.6 million compared to DKK
562.9 million at the end of 2010.


Shareholders' equity equalled DKK 436.2 million as of 31 March, 2011, compared
to DKK 498.2 million at the end of 2010.







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 2010.


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
2011, which was EUR 1.00 = DKK 7.4567.





Grant of warrants





At a board meeting held on 10 May 2011, the Board of Directors decided to issue
250,000 warrants to the Board of Directors of LCP.


By application of the Black-Scholes formula, the market value of the warrant
program can be calculated as DKK 0.5 per warrant assuming an exercise price of
DKK 1.16, equal to the closing price of the Company's share at the NASDAQ OMX
Copenhagen on 10 May 2011, based on an interest rate of 2.56% and a volatility
of the Company's shares of 52%.


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







Conference Call

On 11 May, 2011, LCP's Management will host a conference call, at 3:00 PM CET
(Denmark); 2:00 PM GMT (London), 9:00 AM ET (New York), 6:00 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 64356225


Following the conference call, a recording will be available on the company's
website www.lcpharma.com.



For more information, please contact:


John Weinberg, M.D.
Johnny Stilou

SVP, Commercial Operations & Investor Relations
CFO

Phone: +1 732 321 3208
Phone: +45 20 55 38 52

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.











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, 10 May, 2011



Executive Management



Dr. William J. Polvino Peter G. Nielsen

President and CEO Executive Vice President



Board of Directors



Kim Björnstrup Thomas Dyrberg
Kurt Anker Nielsen

(Chairman) (Deputy Chairman)



Anders Götzsche Mette Kirstine Agger


















Financial
Highlights
Quarterly Numbers
in DKK

Q1 Q4 Q3 Q2 Q1
2011 2010 2010 2010 2010
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
--------------------------------------------------------------------------------

Income Statement
Revenue - - 3 871 623
Research and (52,261) (48,302) (66,150) (39,625) (56,349)
development costs
Administrative (11,724) (13,439) (12,829) (12,773) (13,157)
expenses
One-off - - - - (10,894)
restructuring cost
Operating loss (63,985) (61,741) (78,976) (51,527) (79,777)
Net financial (1,850) 461 (695) (313) (212)
income /
(expenses)
Loss before tax (65,835) (61,281) (79,671) (51,840) (79,989)
Tax for the period - (168) (862) (395) -
Net loss for the (65,835) (61,448) (80,533) (52,235) (79,989)
period
--------------------------------------------------------------------------------

Balance Sheet
Cash and cash 462,319 531,519 134,022 205,136 261,918
equivalents
Total assets 490,578 562,906 163,651 245,345 302,353
Share capital 452,543 452,543 56,568 56,568 56,568
Total equity 436,200 498,238 111,902 189,958 240,383
Investment in 621 1,548 441 101 493
property, plant
and equipment
--------------------------------------------------------------------------------

Cash Flow Statement
Cash flow from (65,396) (45,568) (67,109) (55,659) (69,812)
operating
activities
Cash flow from (299,602) (1,548) (281) (246) (583)
investing
activities
Cash flow from (1,407) 444,519 (2,059) (1,351) (1,095)
financing
activities
Cash and cash 462,319 531,519 134,022 205,136 261,918
equivalents at
period end
--------------------------------------------------------------------------------

Financial Ratios
Basic and diluted (0.15) (0.64) (1.42) (0.92) (1.41)
EPS
Weighted average 452,542,480 96,707,708 56,567,810 56,567,810 56,567,810
number of shares
Average number of 54 54 51 60 69
employees (FTEs)
Assets/equity 1.12 1.13 1.46 1.29 1.26
--------------------------------------------------------------------------------



Financial
Highlights
Quarterly Numbers
in EUR

Q1 Q4 Q3 Q2 Q1
2011 2010 2010 2010 2010
EUR'000 EUR'000 EUR'000 EUR'000 EUR'000
--------------------------------------------------------------------------------

Income Statement
Revenue - - 117 84
Research and (7,009) (6,478) (8,871) (5,314) (7,557)
development costs
Administrative (1,572) (1,802) (1,720) (1,713) (1,765)
expenses
One-off - - - - (1,461)
restructuring cost
Operating loss (8,581) (8,280) (10,591) (6,910) (10,699)
Net financial (248) 62 (93) (42) (28)
income /
(expenses)
Loss before tax (8,829) (8,218) (10,684) (6,952) (10,727)
Tax for the period - (22) (116) (53) -
Net loss for the (8,829) (8,240) (10,800) (7,005) (10,727)
period
--------------------------------------------------------------------------------

Balance Sheet
Cash and cash 62,001 71,281 17,973 27,510 35,125
equivalents
Total assets 65,790 75,490 21,947 32,903 40,548
Share capital 60,689 60,689 7,586 7,586 7,586
Total equity 58,498 66,817 15,007 25,475 32,237
Investment in 83 208 59 14 66
property, plant
and equipment
--------------------------------------------------------------------------------

Cash Flow Statement
Cash flow from (8,770) (6,111) (9,000) (7,464) (9,362)
operating
activities
Cash flow from (40,179) (208) (38) (33) (78)
investing
activities
Cash flow from (189) 59,613 (276) (181) (147)
financing
activities
Cash and cash 62,001 71,281 17,973 27,510 35,125
equivalents at
period end
--------------------------------------------------------------------------------

Financial Ratios
Basic and diluted (0.02) (0.09) (0.19) (0.12) (0.19)
EPS
Weighted average 452,542,480 96,707,708 56,567,810 56,567,810 56,567,810
number of shares
Average number of 54 54 51 60 69
employees (FTEs)
Assets/equity 1.12 1.13 1.46 1.29 1.26
--------------------------------------------------------------------------------

Statements of comprehensive income



Income Statement Consolidated

(DKK'000) Q1 Q1 Year
2011 2010 2010
------------------------------------------------------------------------------

Revenue - 623 1,496
Research and development costs (52,261) (56,349) (210,426)
Administrative expenses (11,724) (13,157) (52,198)
One-off restructuring cost - (10,894) (10,894)
------------------------------------------------------------------------------

Operating loss (63,985) (79,777) (272,022)
------------------------------------------------------------------------------

Financial income 1,645 699 3,635
Financial expenses (3,495) (911) (4,394)
------------------------------------------------------------------------------

Loss before tax (65,835) (79,989) (272,781)
------------------------------------------------------------------------------

Tax for the period - - (1,425)
------------------------------------------------------------------------------

Net loss for the period (65,835) (79,989) (274,206)
------------------------------------------------------------------------------




Basic and diluted EPS (0.15) (1.41) (2.84)
------------------------------------------------------------------------------

Weighted average number of shares 452,542,480 56,567,810 96,707,708
------------------------------------------------------------------------------




Statements of comprehensive income Consolidated

(DKK'000) Q1 Q1 Year
2011 2010 2010
------------------------------------------------------------------------------

Net loss for the period (65,835) (79,989) (274,206)
Other comprehensive income:
Currency translation differences 271 12 136
------------------------------------------------------------------------------

Other comprehensive income for the period 271 12 136
------------------------------------------------------------------------------

Total comprehensive income for the period (65,564) (79,977) (274,070)
------------------------------------------------------------------------------

Balance sheet



Assets Consolidated

(DKK'000) 31 Mar. 31 Mar. 31 Dec.
2011 2010 2010
-------------------------------------------------------------

Patent rights and software 2,035 836 1,938
-------------------------------------------------------------

Intangible assets 2,035 836 1,938
-------------------------------------------------------------


Property, plant and equipment 11,099 17,074 11,950
Leasehold improvements 5,317 7,218 5,858
-------------------------------------------------------------

Property, plant and equipment 16,416 24,292 17,808
-------------------------------------------------------------

Non-current assets 18,451 25,128 19,746
-------------------------------------------------------------


Trade receivables - 303 -
Other receivables 6,325 6,206 8,590
Prepayments 3,483 8,798 3,051
-------------------------------------------------------------

Receivables 9,808 15,307 11,641
-------------------------------------------------------------

Securities 299,039 - -
Cash 163,281 261,918 531,519

-------------------------------------------------------------
Cash and cash equivalents 462,319 261,918 531,519
-------------------------------------------------------------

Current assets 472,127 277,225 543,160
-------------------------------------------------------------

Assets 490,578 302,353 562,906
-------------------------------------------------------------

Balance sheet



Equity & Liabilities Consolidated

(DKK'000) 31 Mar. 31 Mar. 31 Dec.
2011 2010 2010
--------------------------------------------------------

Share capital 452,543 56,568 452,543
Share premium (18,708) 181,845 43,601
Translation reserves 2,365 1,970 2,094
--------------------------------------------------------

Equity 436,200 240,383 498,238
--------------------------------------------------------

Finance lease 7,118 12,755 8,532
--------------------------------------------------------

Non-current liabilities 7,118 12,755 8,532
--------------------------------------------------------

Finance lease 5,749 5,628 5,742
Trade payables 12,045 12,832 23,528
Other payables 29,466 30,755 26,866
--------------------------------------------------------

Current liabilities 47,260 49,215 56,136
--------------------------------------------------------

Liabilities 54,378 61,970 64,668
--------------------------------------------------------

Equity and liabilities 490,578 302,353 562,906
--------------------------------------------------------

Cash flow statements



Cash Flow Statement Consolidated

(DKK'000) Q1 Q1 Year
2011 2010 2010
--------------------------------------------------------------------------------

Operating loss (63.985) (79.777) (272.022)

Share-based payment 3.526 3.079 9.810
Depreciation and amortization 1.899 2.493 9.957
Changes in working capital (6.649) 4.057 14.835
--------------------------------------------------------------------------------

Cash flow from operating activities before (65.209) (70.148) (237.420)
interest

Interest received 1.047 612 1.689
Interest paid (1.234) (276) (992)
Corporate tax paid - - (1.425)
--------------------------------------------------------------------------------

Cash flow from operating activities (65.396) (69.812) (238.148)
--------------------------------------------------------------------------------


Purchase of property, plant and equipment (621) (493) (2.583)
Investments in and sale of bonds (299.039) - -
Cash transfer to restricted security deposit 58 (90) (75)
--------------------------------------------------------------------------------

Cash flow from investing activities (299.602) (583) (2.658)
--------------------------------------------------------------------------------


Installments on bank borrowings and finance (1.407) (1.095) (5.203)
lease
Proceeds from issuance of shares, net - - 445.217
--------------------------------------------------------------------------------

Cash flow from financing activities (1.407) (1.095) 440.014
--------------------------------------------------------------------------------


Increase/(decrease) in cash (366.405) (71.490) 199.208
Cash at beginning of period 530.081 332.066 332.066
Exchange gains/(losses) on cash (1.775) (110) (1.193)
--------------------------------------------------------------------------------

Cash at end of period 161.901 260.466 530.081
--------------------------------------------------------------------------------


Cash and cash equivalents at end of period
comprise:

Restricted bank deposit 1.379 1.452 1.438
Securities 299.039 - -
Deposit on demand and cash 161.901 260.466 530.081
--------------------------------------------------------------------------------

462.319 261.918 531.519
--------------------------------------------------------------------------------

Statement of changes in equity



Consol
idated
Equit
y
Number of Share Share Translation Retained Total
Shares Capital Premium Reserves Earnings
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
--------------------------------------------------------------------------------

Equity 56.567.810 56.568 1.080.263 1.958 (821.508) 317.281
as of
1
Janua
ry
2010
--------------------------------------------------------------------------------

Total 12 (79.989) (79.977)
compr
ehensi
ve
incom
e

Share- 3.079 3.079
based
payme
nt
Transf (898.418) 898.418 -
er of
retai
ned
earni
ngs
--------------------------------------------------------------------------------

Equity 56.567.810 56.568 181.845 1.970 - 240.383
as of
31
March
2010
--------------------------------------------------------------------------------

Total 124 (194.217) (194.093)
compr
ehensi
ve
incom
e

Issuan 395.974.670 395.975 79.195 475.170
ce of
share
s
Share- 6.731 6.731
based
payme
nt
Costs (29.953) (29.953)
relat
ed to
capit
al
incre
ases
Transf (187.486) 187.486 -
er of
retai
ned
earni
ngs
--------------------------------------------------------------------------------

Equity 452.542.480 452.543 43.601 2.094 - 498.238
as of
31
Decem
ber
2010
--------------------------------------------------------------------------------

Total 271 (65.835) (65.564)
compr
ehensi
ve
incom
e

Share- 3.526 3.526
based
payme
nt
Transf (62.309) 62.309 -
er of
retai
ned
earni
ngs
--------------------------------------------------------------------------------

Equity 452.542.480 452.543 (18.708) 2.365 - 436.200
as of
31
March
2011
--------------------------------------------------------------------------------


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.

100511 LifeCycle Pharma Result First Three Months 2011.pdf