Company Announcement no. 13/2010

To: NASDAQ OMX Copenhagen Hørsholm, Denmark, 18 August, 2010

LifeCycle Pharma announces result for the first half 2010 in line with
expectations

Major achievement in reaching agreement with FDA on the pivotal phase 3 study
for LCP- Tacro™

Highlights:

• LCP has entered into an agreement with the U.S. Food and Drug Administration
(FDA) on a Special Protocol Assessment (SPA) of its pivotal Phase 3 study, for
LCP-Tacro™ in patients, who have just received a kidney transplant (“de novo”
transplant patients).

• Positive results have been obtained from a Phase 2 clinical trial for
LCP-TacroTM in de novo kidney transplant patients. These data confirm the
previous positive experience with LCP-Tacro™ in stable kidney and liver
transplant patients and support comparability of LCP's extended release tablet
formulation of tacrolimus when compared to twice daily Prograf® capsules.
Further, the results indicate that LCP-Tacro™ tablets may be safely and
efficaciously administered once daily immediately following a kidney
transplant.

• Edward E. Koval and Dr. John Weinberg have joined LCP's senior management
team as Senior Vice President, Business Development and Strategic Corporate
Development, and Senior Vice President, Commercial Development and Strategic
Planning, respectively. Subsequently Johnny Stilou has been promoted to Chief
Financial Officer.

• LCP reported a net loss of DKK 132.2 million for the first half of 2010
compared to a net loss of DKK 144.3 million for the same period in 2009. The
reported net loss is in line with the expectations for 2010 which were
announced in the annual report for 2009 published on 24 February, 2010.

• For the first half of 2010, LCP's research and development costs amounted to
DKK 96.0 million compared to DKK 120.4 million during the same period in 2009.

• On 30 June, 2010, LCP had cash and cash equivalents of DKK 205.1 million.

William J Polvino, president and CEO said: “The SPA Agreement for LCP-TacroTM
pivotal phase 3 study is a very significant achievement for LCP. We have now
received a formal green light from the FDA as to our proposed clinical study
design and are now well-positioned to move forward with the study start.
Further, we have achieved increased clarity on the costs and timing to
regulatory approval. “

A conference call will be held today, 18 August, 2010 at 5:30 PM CET (Denmark).
Please refer to page 7 for further details.


Outlook for 2010
LCP maintains its 2010 outlook with an operating loss of DKK 260-290 million
and likewise a net loss of DKK 260-290 million.

The Company's 31 December, 2010 cash position is expected to be in the range of
DKK 50-100 million.

Research & development update
LCP-Tacro™ in kidney patients (stable patients)
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 clinical trial is progressing according to plan, and
approx. 100 patients have currently completed their treatment. We expect as
previously announced to complete the treatment in stable kidney patients in
first quarter of 2011.

LCP-Tacro™ in kidney patients (de novo patients)
As announced we have entered into an agreement with the U.S. Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA) of the pivotal
Phase 3 study, for LCP-Tacro™ in patients, who have just received a kidney
transplant (“de novo” transplant patients).

The study is a randomized, double-blind, multicenter study that will compare
once-daily LCP-Tacro™ against the current market leading comparator,
twice-daily Prograf® in de novo kidney transplant patients. A 12-month
treatment period will be followed by a 12-month blinded extension. The primary
endpoint of the study will be to demonstrate the non-inferiority of LCP-Tacro™,
compared to Prograf®, on kidney graft function (biopsy proven acute rejection,
graft failure, death, or loss to follow up) at 12 months. Secondary endpoints
will include safety, tolerability and renal function assessments. The study
will be conducted at approximately 75-100 transplant centers, primarily in the
United States and Europe, and entail the enrollment of 540 patients.

Study initiation is anticipated in the third quarter of this year.



Key Figures

YTD YTD Q2 Q2 Year
2010 2009 2010 2009 2009
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000

Income Statement
Revenue 1,494 1,847 871 1,499 2,476
Research and development costs (95,973) (120,414) (39,625) (57,604) (210,140)
Administrative expenses (25,930) (33,338) (12,773) (16,357) (62,381)
One-off restructuring cost (10,894) - - - (9,489)
Operating loss (131,303) (151,905) (51,527) (72,462) (279,534)
Net financial income / (expenses) (526) 7,630 (313) (2,105) 8,540
Loss before tax (131,829) (144,275) (51,840) (74,567) (270,994)
Tax for the period (395) - (395) - -
Net loss for the period (132,224) (144,275) (52,235) (74,567) (270,994)

Balance Sheet
Cash and cash equivalents 205,136 439,809 205,136 439,809 333,429
Total assets 245,345 500,455 245,345 500,455 379,269
Share capital 56,568 56,439 56,568 56,439 56,568
Total equity 189,958 436,727 189,958 436,727 317,281
Investment in property, plant and equipment 594 9,664 101 7,149 11,043

Cash Flow Statement
Cash flow from operating
activities (125,471) (149,644) (55,659) (71,872) (251,158)
Cash flow from investing activities (829) (9,664) (246) (7,064) (11,011)
Cash flow from financing activities (2,446) 2,488 (1,351) 2,593 729
Cash and cash equivalents at period end 205,136 439,809 205,136 439,809
333,429

Financial Ratios
Basic and diluted EPS (2.34) (2.56) (0.92) (1.32) (4.80)
Weighted average number of shares 56,567,810 56,368,329 56,567,810
56,438,320 56,443,701
Average number of employees (FTEs) 65 101 60 99 93
Assets/equity 1.29 1.15 1.29 1.15 1.20

The interim report is unaudited.


Revenue
For the first half of 2010 LCP recognized DKK 1.5 million in revenues compared
to DKK 1.8 million in the same period of 2009. Revenue consists of payments
under LCP's collaboration agreements.

Research and development costs
For the first half of 2010, LCP's research and development costs amounted to
DKK 96.0 million compared to DKK 120.4 million during the same period in 2009.
The decrease is mainly due to fluctuations in activity in connection with the
ongoing Phase 3 trial for LCP-TacroTM (Stable kidney transplant patients),
combined with the effect of the reduction in force that has taken place during
the past 12 months.

Administrative expenses
For the first half of 2010, LCP's administrative cost amounted to DKK 25.9
million compared to DKK 33.3 million during the same period 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 past 12 months.

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 half of 2010, a total of DKK 5.0 million was recognized as
share-based compensation. The cost is included in R&D and G&A. The comparable
cost for 2009 was DKK 7.4 million.

In the second quarter of 2010, a total of 150,000 warrants were granted to
employees at a strike price of DKK 4.87. In the second quarter of 2010, a total
of 429,759 warrants have been cancelled.

As of 30 June, 2010, there were a total of 4,345,917 warrants outstanding at an
average strike price of DKK 17.1. Members of the Board of Directors held
350,667 warrants at an average strike price of DKK 21.8. Members of the
Executive Management held 807,572 warrants at an average strike price of DKK
12.8, while other current and former employees held 3,187,678 warrants at an
average strike price of DKK 17.7.

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 half of 2010 was DKK 131.3 million compared
to DKK 151.9 million in the corresponding period of 2009.

Financial income
During the first half of 2010, the Company recognized net financial expenses of
DKK 0.5 million compared to an income of DKK 7.6 million in the corresponding
period of 2009. The decrease in financial income is a reflection of lower
earned interest on a lower cash position during the period and currency loss
related to the increased DKK/USD rate.


Net loss
LCP's net loss for the first half of 2010 was DKK 132.2 million compared to DKK
144.3 million in the corresponding period of 2009.

Cash flow
As per 30 June, 2010, the balance sheet reflects cash and cash equivalents to
DKK 205.1 million compared to DKK 333.4 million as per 31 December, 2009. This
represents a decrease of DKK 128.3 million primarily related to the Company's
operating activities for the period.

Balance sheet
As per 30 June, 2010, total assets were DKK 245.3 million compared to DKK 379.3
million at the end of 2009.

Shareholders' equity equalled DKK 190.0 million as of 30 June, 2010, compared
to DKK 317.3 million at the end of 2009.


Accounting policies
The interim report is prepared in compliance with International Accounting
Standard No. 34 (IAS 34), “Interim Financial Reporting” and in accordance with
the NASDAQ OMX Copenhagen's financial reporting requirements for listed
companies.

There have been no changes in accounting policies used for the interim report
compared to the accounting policies used in the preparation of LifeCycle Pharma
group's annual report for 2009.

The line “one-off restructuring cost” includes major restructuring costs,
mainly salary to former employees and is shown separately to facilitate the
comparability of the income statement between periods.

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 30 June,
2010, which was EUR 1.00 = DKK 7.4488.

Major shareholders
Lfi A/S 28.2%
Novo A/S 23.8%
Alta Partners 6.3%



Grant of warrants

At a board meeting held on 18 August, 2010, the Board of Directors decided to
issue 372,000 warrants to the Board of Directors and employees of the LCP.
Of the total granted warrants, 120,000 warrants were granted to the Board of
Directors, 100,000 warrants were granted to Edward E. Koval, Senior Vice
President, Business Development and Strategic Corporate Development, 100,000
warrants were granted to Dr. John Weinberg, Senior Vice President, Commercial
Development and Strategic Planning and 25,000 warrants were granted to Johnny
Stilou, Chief Financial Officer.

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 19 August, 2010, thus ensuring that the
exercise price reflects the fair market price per share following the
disclosure of the interim report for the first half of 2010.

By application of the Black-Scholes formula, the market value of the warrant
program can be calculated as DKK 1.6 per warrant assuming an exercise price of
DKK 4.05, equal to the closing price of the Company's share at the NASDAQ OMX
Copenhagen on 17 August, 2010, based on an interest rate of 1.12% and a
volatility of the Company's shares set to 48%.

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


Conference Call
Today, 18 August, 2010, LCP's Management will host a conference call, at 5:30
PM CET (Denmark); 4:30 PM GMT (London), 11:30 AM ET (New York), 8:30 AM PT (San
Francisco).

To access the live conference call, please dial one of the following numbers:
+45 32 71 35 00 Denmark
+44 (0)20 7138 0844 UK
+1 212 444 0896 USA
Access code 1264445

A call audio replay of the conference call will be available on
www.lcpharma.com from tomorrow Thursday, 19 August, 2010 at 18:00 PM CET
(Denmark); 17:00 PM GMT (London), 12:00 PM ET (New York), 9:00 AM PT (San
Francisco), through Friday, 10 September, 2010 by dialing +45 32 71 09 13 (DK),
+44 (0) 20 7111 1244 (UK) or +1 347 366 9565 (US), and entering access code
1264445#.

Additional information:
Dr. William J. Polvino
President and CEO
+1 (917) 647 9107
[email protected]




The forward looking statements and targets contained herein are based on
LifeCycle Pharma A/S' management's current view and assumptions. Such
statements involve known and unknown risks and uncertainties that may cause
actual results, performance or events to differ materially from those
anticipated herein. LifeCycle Pharma A/S expressly disclaim any obligation or
undertaking to update or revise any forward looking statements, targets or
estimates contained in this interim report to reflect any change in events,
conditions, assumptions, or circulations on which any such statements are based
unless required by applicable law.


About LifeCycle Pharma A/S (LCP)
Based in Hørsholm, Denmark, with an office in New York, LCP is an emerging
specialty pharmaceutical company. Clinical development is the core of LCP's
effort to develop a product portfolio which includes products for
immunosuppression, specifically organ transplantation, and products to combat
certain cardiovascular diseases. As a fully integrated company, LCP adapts new
technologies on a fast commercial timetable. LCP's unique, patented delivery
technology, MeltDose®, can improve absorption and bioavailability - at
low-scale up costs - not only for a broad spectrum of drugs already on the
market but also for new chemical entities. LCP has a cholesterol-lowering
product, Fenoglide™, currently on the U.S. market and a diversified near- and
medium-term pipeline with four product candidates in clinical trials and a
number of projects in preclinical development. LCP is listed on the NASDAQ OMX
Copenhagen under the trading symbol (OMX: LCP). For further information, please
visit www.lcpharma.com.

Executive Management's and the Board of Directors' Statement on the Interim
Report


The Executive Management and the Board of Directors have considered and adopted
the Interim Report of LifeCycle Pharma A/S.

The Interim Report is prepared in accordance with International Accounting
Standard No. 34 (IAS 34), “Interim Financial Reporting” and additional Danish
disclosure requirements for financial reporting of listed companies.

We consider the applied accounting policies to be appropriate and, in our
opinion, the Interim Report gives a true and fair view of the assets and
liabilities, financial position, results of the operation and cash flow of the
group for the period under review. Furthermore, in our opinion the management
review includes a fair review of the development and performance of the
business and the financial position of the group, together with a description
of the material risks and uncertainties the group faces. The group does not
face any material risks or uncertainties relating to the financial statements.


Hørsholm, 18 August, 2010

Executive Management

Dr. William J. Polvino Peter G. Nielsen
President and CEO Executive Vice President

Board of Directors

Paul Edick Thomas Dyrberg Kurt Anker Nielsen
(Chairman) (Deputy Chairman)



Jean Deleage Gérard Soula Anders Götzsche




Mette Kirstine Agger



Quarterly Numbers in DKK

Q2 Q1 Q4 Q3 Q2 Q1
2010 2010 2009 2009 2009 2009
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000 DKK'000

Income Statement
Revenue 871 623 182 447 1,499 349
Research and development costs (39,625) (56,349)
(45,740) (43,986) (57,604) (62,810)
Administrative expenses (12,773) (13,157) (14,713) (14,330) (16,357) (16,981)
One-off restructuring cost - (10,894) - (9,489) - -
Operating loss (51,527) (79,777) (60,271) (67,358) (72,462) (79,443)
Net financial income / (expenses) (313) (212) 516 394 (2,105) 9,735
Loss before tax (51,840) (79,989) (59,755) (66,964) (74,567) (69,708)
Tax for the period (395) - - - - -
Net loss for the period (52,235) (79,989) (59,755) (66,964) (74,567) (69,708)

Balance Sheet
Cash and cash equivalents 205,136 261,918 333,429 392,133 439,809
520,228
Total assets 245,345 302,353 379,269 444,915 500,455 574,148
Share capital 56,568 56,568 56,568 56,568 56,439 56,439
Total equity 189,958 240,383 317,281 373,583 436,727 507,712
Investment in property, plant and equipment 101 493 489 890 7,149 2,515

Cash Flow Statement
Cash flow from operating activities (55,659) (69,812)
(56,800) (44,714) (71,872) (77,772)
Cash flow from investing activities (246) (583) (504) (843) (7,064) (2,600)
Cash flow from financing activities (1,351) (1,095) (1,312) (446) 2,593 (105)
Cash and cash equivalents at period end 205,136 261,918 333,429 392,133
439,809 520,228

Financial Ratios
Basic and diluted EPS (0.92) (1.41) (1.06) (1.19) (1.32) (1.24)
Weighted average number of shares 56,567,810 56,567,810 56,443,701
56,467,878 56,438,320 56,297,561
Average number of employees (FTEs) 60 69 77 88 99 102
Assets/equity 1.29 1.26 1.20 1.19 1.15 1.13


Quarterly Numbers in Euro

Q2 Q1 Q4 Q3 Q2 Q1
2010 2010 2009 2009 2009 2009
EUR'000 EUR'000 EUR'000 EUR'000 EUR'000 EUR'000

Income Statement
Revenue 117 84 24 60 201 47
Research and development costs (5,320) (7,565) (6,140) (5,905) (7,734) (8,432)
Administrative expenses (1,714) (1,766) (1,975) (1,924) (2,195) (2,280)
One-off restructuring cost - (1,462) - (1,274) - -
Operating loss (6,917) (10,709) (8,091) (9,043) (9,728) (10,665)
Net financial income / (expenses) (42) (29) 69 53 (283) 1,307
Loss before tax (6,959) (10,738) (8,022) (8,990) (10,011) (9,358)
Tax for the period (53) - - - - -
Net loss for the period (7,012) (10,738) (8,022) (8,990) (10,011) (9,358)

Balance Sheet
Cash and cash equivalents 27,539 35,162 44,763 52,644 59,044 69,840
Total assets 32,937 40,591 50,917 59,730 67,186 77,079
Share capital 7,594 7,594 7,594 7,594 7,577 7,577
Total equity 25,502 32,271 42,595 50,153 58,630 68,160
Investment in property, plant and equipment 14 66 66 120 960 338

Cash Flow Statement
Cash flow from operating activities (7,472) (9,372)
(7,625) (6,003) (9,649) (10,441)
Cash flow from investing activities (33) (78) (68) (113) (948) (349)
Cash flow from financing activities (181) (147) (176) (60) 348 (14)
Cash and cash equivalents at period end 27,539 35,162 44,763 52,644
59,044 69,840

Financial Ratios
Basic and diluted EPS (0.12) (0.19) (0.14) (0.16) (0.18) (0.17)
Weighted average number of shares 56,567,810 56,567,810 56,443,701
56,467,878 56,438,320 56,297,561
Average number of employees (FTEs) 60 69 77 88 99 102
Assets/equity 1.29 1.26 1.20 1.19 1.15 1.13


Income Statement Consolidated

(DKK'000) YTD YTD Q2 Q2 Year
2010 2009 2010 2009 2009

Revenue 1,494 1,847 871 1,499 2,476
Research and development costs (95,973) (120,414) (39,625) (57,604) (210,140)
Administrative expenses (25,930) (33,338) (12,773) (16,357) (62,381)
One-off restructuring cost (10,894) - - - (9,489)

Operating loss (131,303) (151,905) (51,527) (72,462) (279,534)

Financial income 1,183 17,844 485 2,631 21,391
Financial expenses (1,709) (10,214) (798) (4,736) (12,851)

Loss before tax (131,829) (144,275) (51,840) (74,567) (270,994)

Tax for the period (395) - (395) - -

Net loss for the period (132,224) (144,275) (52,235) (74,567) (270,994)




Basic and diluted EPS (2.34) (2.56) (0.92) (1.32) (4.80)

Weighted average number of shares 56,567,810 56,368,329 56,567,810
56,438,320 56,443,701




Statements of comprehensive income Consolidated

(DKK'000) YTD YTD Q2 Q2 Year
2010 2009 2010 2009 2009

Net loss for the period (132,224) (144,275) (52,235) (74,567) (270,994)
Other comprehensive income:
Currency translation differences (56) 368 (68) 63 215

Other comprehensive income for the period (56) 368 (68) 63 215

Total comprehensive income for the
period (132,280) (143,907) (52,303) (74,504) (270,779)


Assets Consolidated

(DKK'000) 30 June 30 June 31 Dec.
2010 2009 2009

Patent rights and software 812 654 860

Intangible assets 812 654 860


Property, plant and equipment 15,225 22,198 18,753
Leasehold improvements 6,688 8,457 7,506

Property, plant and equipment 21,913 30,655 26,259

Non-current assets 22,725 31,309 27,119


Trade receivables - 751 302
Other receivables 6,590 12,338 4,390
Prepayments 10,894 16,248 14,029

Receivables 17,484 29,337 18,721

Cash and cash equivalents 205,136 439,809 333,429

Current assets 222,620 469,146 352,150

Assets 245,345 500,455 379,269


Equity & Liabilities Consolidated

(DKK'000) 30 June 30 June 31 Dec.
2010 2009 2009

Share capital 56,568 56,439 56,568
Share premium 1,080,263 1,079,554 1,080,263
Translation reserves 1,902 2,111 1,958
Retained earnings/loss (948,775) (701,377) (821,508)

Equity 189,958 436,727 317,281

Provisions - 10,492 -
Finance lease 11,441 16,820 14,091

Non-current liabilities 11,441 27,312 14,091

Finance lease 5,590 5,245 5,387
Trade payables 12,462 10,216 19,794
Deferred revenue - - 120
Other payables 25,894 20,955 22,596

Current liabilities 43,946 36,416 47,897

Liabilities 55,387 63,728 61,988

Equity and liabilities 245,345 500,455 379,269


Cash Flow Statement Consolidated

(DKK'000) YTD YTD Q2 Q2 Year
2010 2009 2010 2009 2009

Operating loss (131,303) (151,905) (51,527) (72,462) (279,534)

Share-based payment 4,957 7,355 1,878 3,529 13,934
Depreciation and amortization 5,006 4,891 2,513 2,594 10,455
Changes in working capital (3,798) (19,526) (7,855) (3,381) (3,188)

Cash flow from operating activities before
interest (125,138) (159,185) (54,991) (69,720) (258,333)

Interest received 962 19,858 351 2,703 8,366
Interest paid (532) (10,317) (256) (4,855) (1,191)
Corporate tax paid (763) - (763) - -

Cash flow from operating
activities (125,471) (149,644) (55,659) (71,872) (251,158)


Purchase of property, plant and equipment (594) (9,664) (101) (7,149) (11,043)
Cash transfer to restricted security deposit (235) - (145) 85 32

Cash flow from investing activities (829) (9,664) (246) (7,064) (11,011)


Installments on bank borrowings and finance lease (2,446) 1,533 (1,351) 2,603
(1,055)
Proceeds from issuance of shares, net - 955 - (10) 1,784

Cash flow from financing activities (2,446) 2,488 (1,351) 2,593 729


Increase/(decrease) in cash and cash
equivalents (128,746) (156,820) (57,256) (76,343) (261,440)
Cash and cash equivalents at beginning of period 332,066 598,735 260,466
518,749 598,735
Exchange gains/(losses) on cash and cash equivalent 219 (3,501) 329
(3,992) (5,229)

Cash and cash equivalents at end of period 203,539 438,414 203,539 438,414
332,066


Cash and cash equivalents at end of period comprise:

Restricted bank deposit 1,597 1,395 1,597 1,395 1,363
Deposit on demand and cash 203,539 438,414 203,539 438,414 332,066

205,136 439,809 205,136 439,809 333,429


Consolidated Equity
Number of Shares Share Capital Share Premium Translation
Reserves Retained Earnings Total
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000

Equity as of 1 January 2009 56,287,507 56,288 1,078,740 1,743
(564,448) 572,323

Total comprehensive income 368 (144,275) (143,907)

Warrant exercises 150,813 151 814 965
Share-based payment 7,346 7,346

Equity as of 30 June 2009 56,438,320 56,439 1,079,554 2,111
(701,377) 436,727

Total comprehensive income (153) (126,719) (126,872)

Warrant exercises 129,490 129 709 838
Share-based payment 6,588 6,588

Equity as of 31 December 2009 56,567,810 56,568 1,080,263 1,958
(821,508) 317,281

Total comprehensive income (56) (132,224) (132,280)

Share-based payment 4,957 4,957

Equity as of 30 June 2010 56,567,810 56,568 1,080,263 1,902
(948,775) 189,958

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 half year report 2010.pdf