Veloxis Pharmaceuticals Publishes Annual Report 2011

HORSHOLM, Denmark, March 7, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2011. 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 Veloxis' annual report 2011 published separately today.

Full Year 2011 Highlights

  • Positive phase III results in the LCP-Tacro™ Trial in stable kidney transplant patients which met all primary efficacy and safety endpoints.

  • Award of a DKK 3.9 million grant from The Danish National Advanced Technology Foundation to support development of an oral chemotherapy agent.

  • Company name changed from LifeCycle Pharma.

  • Licensing of US commercial Fenoglide® (fenofibrate) rights to Santarus and settlement of Impax patent litigation.

  • Veloxis and Athena Drug Delivery Solutions Pvt. Ltd. partnership to develop, manufacture and commercialize Veloxis' investigational drug AtorFen™ (Fenofibrate-Atorvastin fixed dose combination) in certain emerging markets.

  • During 2011, Veloxis had no revenue compared to DKK 1.5 million in 2010. Revenue in 2010 consisted of payments under Veloxis' collaboration agreements.

  • Research and development costs increased by DKK 11.6 million, or by 5.5%, from DKK 210.4 million in 2010 to DKK 222.0 million in 2011. Research and development costs are mainly attributable to the two phase lll trials of LCP-Tacro™. These costs include the finalization of the phase lll study in kidney transplant patients (stable patients, Study 3001) along with costs associated with the ongoing phase lll study in kidney transplant patients (de novo patients, Study 3002).

  • Administrative expenses decreased by DKK 4.4 million or by 8.4%, from DKK 52.2 million in 2010 to DKK 47.8 million in 2011. The reduction in cost is attributable to the continued focus on reducing overall cost.

  • During 2011, Veloxis recognized DKK 252.6 million in net loss compared to DKK 274.2 million in 2010. The net loss is in line with management's expectations for 2011, which projected a net loss of DKK 250 - 280 million.

  • As per 31 December 2011, the balance sheet reflects cash and cash equivalents of DKK 297.7 million compared to DKK 531.5 million as per 31 December 2010. The decrease in cash position reflects the changes in operating activities in 2011. The cash position is in line with management's expectations for 2011, which projected a cash position at the end of 2011 of DKK 250 - 300 million.

Conference Call

On 7 March, 2012, Veloxis' Management will host a conference call, at 2:00 PM CET (Denmark); 1:00 PM GMT (London), 8:00 AM ET (New York), 5:00 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 57134951

Following the conference call, a recording will be available on the company's website www.veloxis.com. A presentation will be available on Veloxis' website (under 'Investors') one hour prior to the scheduled time of the conference call.


Financial Highlights















2011

2010

2009

2008

2007



DKK'000

DKK'000

DKK'000

DKK'000

DKK'000








Income Statement






Revenue

-

1,496

2,476

170,122

64,705

Research and development costs

(222,053)

(210,426)

(210,140)

(270,875)

(183,608)

Administrative expenses

(47,814)

(52,198)

(62,381)

(73,311)

(54,033)

One-off restructuring cost

-

(10,894)

(9,489)

-

-

Operating loss

(269,867)

(272,022)

(279,534)

(174,064)

(172,936)

Net financial income / (expenses)

16,048

(759)

8,540

24,285

12,697

Loss before tax

(253,819)

(272,781)

(270,994)

(149,779)

(160,239)

Tax for the period

1,193

(1,425)

-

-

-

Net loss for the period

(252,626)

(274,206)

(270,994)

(149,779)

(160,239)








Balance Sheet






Cash and cash equivalents

297,727

531,519

333,429

600,130

331,740

Total assets

320,927

562,906

379,269

646,293

381,912

Share capital

452,543

452,543

56,568

56,288

31,771

Total equity

255,900

498,238

317,281

572,323

325,689

Investment in property, plant and equipment

2,981

2,583

11,043

6,571

5,900








Cash Flow Statement






Cash flow from operating activities

(234,637)

(238,148)

(251,158)

(102,560)

(129,291)

Cash flow from investing activities

(169,778)

(2,658)

(11,011)

(6,628)

(7,298)

Cash flow from financing activities

(5,948)

440,014

729

373,637

3,769

Cash and cash equivalents at period end

297,727

531,519

333,429

600,130

331,740








Financial Ratios






Basic and diluted EPS (DKK)

(0.56)

(2.84)

(4.80)

(3.06)

(5.19)

Weighted average number of shares

452,542,480

96,707,708

56,443,701

49,006,500

30,875,434

Average number of employees (FTEs)

52

59

93

102

64

Assets/equity

1.25

1.13

1.20

1.13

1.17




Fourth Quarter 2011 Highlights

  • Research and development cost were realized at DKK 61.8 million compared to DKK 48.3 million in same period in  2010, and DKK 43.1 million in the previous quarter.

  • Administrative expenses were realized at DKK 11.4 million compared to DKK 13.4 million in same period in 2010, and DKK 12.6 million in the previous quarter.

  • Operating loss amounted to DKK 73.1 million, while net loss was realized at DKK 68.2 million.

Financial Highlights 

Quarterly Numbers in DKK 













Q4

Q3

Q2

Q1

Q4

Q3

Q2

Q1



2011

2011

2011

2011

2010

2010

2010

2010



DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000











Income Statement









Revenue

-

-

-

-

-

3

871

623

Research and development costs

(61,763)

(43,079)

(64,951)

(52,261)

(48,302)

(66,150)

(39,625)

(56,349)

Administrative expenses

(11,385)

(12,568)

(12,137)

(11,724)

(13,439)

(12,829)

(12,773)

(13,157)

One-off restructuring cost

-

-

-

-

-

-

-

(10,894)

Operating loss

(73,148)

(55,647)

(77,088)

(63,985)

(61,741)

(78,976)

(51,527)

(79,777)

Net financial income / (expenses)

4,527

11,363

2,008

(1,850)

461

(695)

(313)

(212)

Loss before tax

(68,620)

(44,284)

(75,080)

(65,835)

(61,281)

(79,671)

(51,840)

(79,989)

Tax for the period

373

1,120

(300)

-

(168)

(862)

(395)

-

Net loss for the period

(68,247)

(43,164)

(75,380)

(65,835)

(61,448)

(80,533)

(52,235)

(79,989)











Balance Sheet









Cash and cash equivalents

297,727

348,252

402,213

462,319

531,519

134,022

205,136

261,918

Total assets

320,927

370,865

426,860

490,578

562,906

163,651

245,345

302,353

Share capital

452,543

452,543

452,543

452,543

452,543

56,568

56,568

56,568

Total equity

255,900

322,516

363,606

436,200

498,238

111,902

189,958

240,383

Investment in property,









plant and equipment

1,123

602

635

621

1,548

441

101

493











Cash Flow Statement









Cash flow from operating activities

(52,139)

(60,481)

(56,621)

(65,396)

(45,568)

(67,109)

(55,659)

(69,812)

Cash flow from investing activities

26,101

25,878

77,845

(299,602)

(1,548)

(281)

(246)

(583)

Cash flow from financing activities

(1,670)

(1,445)

(1,426)

(1,407)

444,519

(2,059)

(1,351)

(1,095)

Cash and cash equivalents









at period end

297,727

348,252

402,213

462,319

531,519

134,022

205,136

261,918











Financial Ratios









Basic and diluted EPS

(0.15)

(0.10)

(0.17)

(0.15)

(0.64)

(1.42)

(0.92)

(1.41)

Weighted average number of shares

452,542,480

452,542,480

452,542,480

452,542,480

96,707,708

56,567,810

56,567,810

56,567,810

Average number of employees (FTEs)

51

51

52

54

54

51

60

69

Assets/equity

1.25

1.15

1.17

1.12

1.13

1.46

1.29

1.26










The quarterly numbers have not been audited.



Outlook for 2012

Veloxis is expecting an operating loss of DKK 220 – 250 million compared to the realized operating loss of DKK 270 million in 2011. The net loss is likewise expected to be in the range of DKK 220 – 250 million compared to the net loss of DKK 253 million in 2011. As of 31 December 2011, the Company's cash position equaled DKK 298 million and the Company's 31 December 2012 cash position is expected to be in the range of DKK 40 - 80 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. The outlook for 2012 does not include any effect from eventual milestone, royalty or partner arrangements.

Management is focused on securing additional funds beyond 2012 by either partner agreements, debt or equity, or a mix thereof.

Important events following the balance sheet date

On 4 January Veloxis announced Initiation of STRATO Study of LCP-Tacro™ in Kidney Transplant Recipients Experiencing Tremors. The STRATO study is designed to explore whether a conversion of patients who have symptomatic tremor from treatment with standard immediate release twice-daily tacrolimus capsules to extended release once-daily LCP-Tacro™ tablets leads to a measurable improvement in tremor.

For more information, please contact:




Veloxis Pharmaceuticals A/S




John D. Weinberg

Johnny Stilou

SVP, Commercial Operations and Investor Relations

CFO

Mobile: +1 732 321 3208

Phone: + 45 21 227 227

Email: jdw@veloxis.com

Email: jst@veloxis.com



The forward looking statements and targets contained herein are based on Veloxis Pharmaceuticals 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. Veloxis Pharmaceuticals 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 Veloxis Pharmaceuticals A/S (Veloxis)

Based in Horsholm, Denmark, with an office in New Jersey, Veloxis is a specialty pharmaceutical company. Clinical development is the core of Veloxis' 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. Veloxis adapts new technologies on a fast commercial timetable. Veloxis' 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. Veloxis 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. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO. For further information, please visit www.veloxis.com

SOURCE Veloxis Pharmaceuticals A/S



RELATED LINKS
http://www.veloxis.com

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