Veloxis Pharmaceuticals publishes Annual Report 2012

HORSHOLM, Denmark, March 6, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2012. 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 2012 published separately today.

Full Year 2012 Highlights

  • Enrollment completed in the pivotal LCP-Tacro™ Phase III study in de novo kidney transplant patients.
  • Restructuring of the company's operations in order to fully focus its resources on the completion of the development and subsequent commercialization of LCP-Tacro™.  Other pipeline activities will be discontinued, including early phase research activities.
  • Exclusive distribution agreement with Chiesi Farmaceutici S.p.A. for the commercialization and distribution of its novel formulation immunosuppressant drug candidate LCP-Tacro™ in certain countries, including Europe, Turkey and CIS countries (Russia and former USSR republics). Under the terms of the agreement, Veloxis will receive up-front and milestone payments of up to USD 47.5 million (in aggregate). The milestone payments are subject to the achievement of certain regulatory milestones and sales targets.
  • Fully subscribed rights issue of 1,206,779,946 offer shares with a nominal value of DKK 0.10 each at DKK 0.35 per share has been completed. The net proceeds from the rights issue is DKK 409 million.
  • Results of a preliminary analysis from the first 16 patients in its Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO) clinical trial. Results from the first 16 patients demonstrated a trend toward a reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro™.
  • During 2012, Veloxis recognized DKK 6.9 million in revenue compared to no revenue in 2011. Revenue in 2012 consist of up-front and milestone payments under Veloxis' distribution agreement with Chiesi Farmaceutici S.p.A.
  • Research and development costs decreased by DKK 11.3 million, or by 5.1%, from DKK 222.0 million in 2011 to DKK 210.7 million in 2012. Research and development costs are mainly attributable to the ongoing phase III trial in LCP-Tacro™ (de novo patients, Study 3002).
  • Administrative expenses decreased by DKK 10.9 million or by 22.9%, from DKK 47.8 million in 2011 to DKK 36.9 million in 2012. 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 May 2012.
  • Restructuring cost includes salary payments to former employees in connection with the reduction in headcount in May 2012 and a write-down of laboratory equipment and laboratory improvements due to the discontinuation of pipeline activities not related to LCP-Tacro™.
  • During 2012, Veloxis recognized DKK 262.7 million in net loss compared to DKK 252.6 million in 2011. The net loss is in line with management's expectations for 2012 as reported on 22 August 2012 in connection with the second quarter interim report, which projected a net loss of DKK 240 - 270 million.
  • As per 31 December 2012, the balance sheet reflects cash and cash equivalents of DKK 496.8 million compared to DKK 297.7 million as per 31 December 2011. The increase in cash position reflects the total net proceeds from the offering of DKK 409 million, partially offset by expenditures associated with the operating activities in 2012. The cash position is in line with management's expectations for 2012, which projected a cash position at the end of 2012 of DKK 490 - 530 million.

Conference Call

On 6 March, 2013, 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 80 18 Denmark
+44 (0) 1452 555 131 UK
+1 866 682 8490 USA
Access code 13759590

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













DKK'000

2012

2011

2010

2009

2008








Income Statement






Revenue

6,868

-

1,496

2,476

170,122

Research and development costs

(210,739)

(222,053)

(210,426)

(210,140)

(270,875)

Administrative expenses

(36,889)

(47,814)

(52,198)

(62,381)

(73,311)

Operating loss before restructuring cost

(240,760)

(269,867)

(261,128)

(270,045)

(174,064)

Restructuring cost

(21,462)

-

(10,894)

(9,489)

-

Operating loss

(262,222)

(269,867)

(272,022)

(279,534)

(174,064)

Net financial income / (expenses)

(850)

16,048

(759)

8,540

24,285

Loss before tax

(263,072)

(253,819)

(272,781)

(270,994)

(149,779)

Tax for the period

363

1,193

(1,425)

-

-

Net loss for the period

(262,709)

(252,626)

(274,206)

(270,994)

(149,779)








Balance Sheet






Cash and cash equivalents

496,834

297,727

531,519

333,429

600,130

Total assets

509,271

320,927

562,906

379,269

646,293

Share capital

165,932

452,543

452,543

56,568

56,288

Total equity

409,737

255,900

498,238

317,281

572,323

Investment in property, plant and equipment

260

2,981

2,583

11,043

6,571








Cash Flow Statement






Cash flow from operating activities

(205,870)

(234,637)

(238,148)

(251,158)

(102,560)

Cash flow from investing activities

169,712

(169,778)

(2,658)

(11,011)

(6,628)

Cash flow from financing activities

404,304

(5,948)

440,014

729

373,637

Cash and cash equivalents at period end

496,834

297,727

531,519

333,429

600,130








Financial Ratios






Basic and diluted EPS (DKK)

(0.43)

(0.56)

(2.84)

(4.80)

(3.06)

Weighted average number of shares

607,511,489

452,542,480

96,707,708

56,443,701

49,006,500

Average number of employees (FTEs)

48

52

59

93

102

Assets/equity

1.24

1.25

1.13

1.20

1.13

 

Fourth Quarter 2012 Highlights

 

  • Research and development cost were realized at DKK 41.9 million compared to DKK 61.8 million in same period in  2011, and DKK 49.4 million in the previous quarter.

 

  • Administrative expenses were realized at DKK 10.2 million compared to DKK 11.4 million in same period in 2011, and DKK 7.0 million in the previous quarter.

 

  • Operating loss amounted to DKK 45.3 million, while net loss was realized at DKK 46.5 million.

 

Financial Highlights









Quarterly Numbers in DKK




















Q4

Q3

Q2

Q1

Q4

Q3

Q2

Q1



2012

2012

2012

2012

2011

2011

2011

2011



DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000











Income Statement









Revenue

6,868

-

-

-

-

-

-

-

Research and development costs

(41,890)

(49,362)

(56,639)

(62,848)

(61,763)

(43,079)

(64,951)

(52,261)

Administrative expenses

(10,235)

(6,961)

(9,462)

(10,231)

(11,385)

(12,568)

(12,137)

(11,724)

Operating loss before restructuring cost

(45,257)

(56,323)

(66,101)

(73,079)

(73,148)

(55,647)

(77,088)

(63,985)

Restructuring cost

-

-

(21,462)

-

-

-

-

-

Operating loss

(45,257)

(56,323)

(87,563)

(73,079)

(73,148)

(55,647)

(77,088)

(63,985)

Net financial income / (expenses)

(2,302)

993

2,051

(1,592)

4,528

11,363

2,008

(1,850)

Loss before tax

(47,559)

(55,330)

(85,512)

(74,671)

(68,620)

(44,284)

(75,080)

(65,835)

Tax for the period

1,034

(223)

(130)

(318)

373

1,120

(300)

-

Net loss for the period

(46,525)

(55,553)

(85,642)

(74,989)

(68,247)

(43,164)

(75,380)

(65,835)











Balance Sheet









Cash and cash equivalents

496,834

86,683

152,720

213,786

297,727

348,252

402,213

462,319

Total assets

509,271

99,590

167,799

235,187

320,927

370,865

426,860

490,578

Share capital

165,932

45,254

45,254

452,543

452,543

452,543

452,543

452,543

Total equity

409,737

42,103

98,968

182,545

255,900

322,516

363,606

436,200

Investment in property,









plant and equipment

43

-

126

91

1,123

602

635

621











Cash Flow Statement









Cash flow from operating activities

(399)

(62,707)

(62,400)

(80,364)

(52,139)

(60,481)

(56,621)

(65,396)

Cash flow from investing activities

56,619

59,486

24,174

29,433

26,101

25,878

77,845

(299,602)

Cash flow from financing activities

410,149

(3,450)

(1,085)

(1,310)

(1,670)

(1,445)

(1,426)

(1,407)

Cash and cash equivalents









at period end

496,834

86,683

152,720

213,786

297,727

348,252

402,213

462,319











Financial Ratios









Basic and diluted EPS

(0.08)

(0.12)

(0.19)

(0.17)

(0.15)

(0.10)

(0.17)

(0.15)

Weighted average number of shares

607,511,489

452,542,480

452,542,480

452,542,480

452,542,480

452,542,480

452,542,480

452,542,480

Average number of employees (FTEs)

33

49

55

55

51

51

52

54

Assets/equity

1.24

2.37

1.70

1.29

1.25

1.15

1.17

1.12











The quarterly numbers have not been audited.







Outlook for 2013

Veloxis is expecting an operating loss of DKK 170 - 200 million compared to the realized operating loss of DKK 262 million in 2012. The net loss is likewise expected to be in the range of DKK 170 - 200 million compared to the net loss of DKK 263 million in 2012. As of 31 December 2012, the Company's cash position equaled DKK 497 million and the Company's 31 December 2013 cash position is expected to be in the range of DKK 270 - 310 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.

For more information, please contact:




Veloxis Pharmaceuticals A/S




John D. Weinberg

Johnny Stilou

Executive Vice President & CCO

Executive Vice President & CFO

Mobile: +1 732 321 3208

Phone: + 45 21 227 227

Email: jdw@veloxis.com

Email: jst@veloxis.com

About LCP-Tacro™ and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP-Tacro™ is an investigational drug that is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak-to-trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.

About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is LCP‐Tacro™ for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low‐scale up costs.  Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Santarus, Inc. 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



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