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Veloxis Pharmaceuticals publishes Annual Report 2012
Submitted by admin on 3/6/2013 @ 5:23 AM
Companies mentioned in this article:
Veloxis Pharmaceuticals A/S
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(TM) 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(TM). 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(TM) 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(TM).
-- 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(TM) (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(TM).
-- 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(TM) and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP-Tacro(TM) 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(TM) 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