Welcome!

News Feed Item

Veloxis Pharmaceuticals publishes Annual Report 2013

HORSHOLM, Denmark, March 5, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2013. 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 2013 published separately today.

Full Year 2013 Highlights

  • Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® for the prevention of organ rejection in kidney transplant recipients.
  • Granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants. The designation is to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases.
  • Dosing of the first patient in ASERTAA (A Study of Extended Release Tacrolimus in African-Americans) Phase IIIb study of Envarsus® in kidney transplant recipients. The ASERTAA study is designed to compare the pharmacokinetics (PK) of Envarsus®, a once-daily tacrolimus tablet, to generic twice daily tacrolimus capsules in stable African-American renal transplant patients.
  • The trade name for LCP-Tacro™ is Envarsus®.
  • Envarsus® successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf® as the comparator, met its primary efficacy and primary safety endpoints.
  • The European Medicines Agency (EMA) accepted for review the company's Marketing Authorization Application (MAA) to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union. Veloxis expects the decision from the European Union in 2014.
  • Data from the STRATO study demonstrates the potential for Envarsus® to improve tacrolimus-induced tremors in stable kidney transplant patients.
  • Submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union.
  • During 2013, Veloxis recognized deferred revenue of DKK 38.2 million as revenue compared to DKK 6.9 million in 2012. Deferred revenue consist of up-front and milestone payments under Veloxis' distribution agreement with Chiesi Farmaceutici S.p.A. and is recognized in the income statement based on planned development periods.
  • Research and development costs decreased by DKK 64.2 million, or by 30.5%, from DKK 210.7 million in 2012 to DKK 146.5 million in 2013. Research and development costs are mainly attributable to the phase III trial in Envarsus® (de novo patients, Study 3002). The reduction in cost between the two periods is mainly related to effect from the executed restructuring and discontinuation of other pipeline activities in May 2012.
  • Administrative expenses decreased by DKK 9.1 million or by 24.7%, from DKK 36.9 million in 2012 to DKK 27.8 million in 2013. 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.
  • During 2013, Veloxis recognized DKK 139.3 million in net loss compared to DKK 262.7 million in 2012. The net loss is better than management's expectations for 2013 as reported on 13 November 2013 in connection with the third quarter interim report, which projected a net loss of DKK 160 - 190 million. The positive deviation is mainly driven by the granted orphan drug status which has reduced regulatory costs.
  • As per 31 December 2013, the balance sheet reflects cash and cash equivalents of DKK 328.7 million compared to DKK 496.8 million as per 31 December 2012. The decrease in cash position reflects the changes in operating activities in 2013. The cash position is in line with management's expectations for 2013, which projected a cash position at the end of 2013 of DKK 310 - 340 million.

Conference Call
On 5 March, 2014, Veloxis' Management will host a conference call, at 2:00 PM CET (Denmark); 1:00 PM GMT (London), 8:00 AM ET (New York).

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 1728236

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').


 


Financial Highlights













DKK'000

2013

2012

2011

2010

2009








Income Statement






Revenue

38,148

6,868

-

1,496

2,476

Research and development costs

(146,512)

(210,739)

(222,053)

(210,426)

(210,140)

Administrative expenses

(27,771)

(36,889)

(47,814)

(52,198)

(62,381)

Operating loss before restructuring cost

(136,135)

(240,760)

(269,867)

(261,128)

(270,045)

Restructuring cost

-

(21,462)

-

(10,894)

(9,489)

Operating loss

(136,135)

(262,222)

(269,867)

(272,022)

(279,534)

Net financial income / (expenses)

(4,426)

(850)

16,048

(759)

8,540

Loss before tax

(140,561)

(263,072)

(253,819)

(272,781)

(270,994)

Tax for the period

1,250

363

1,193

(1,425)

-

Net loss for the period

(139,311)

(262,709)

(252,626)

(274,206)

(270,994)








Balance Sheet






Cash and cash equivalents

328,652

496,834

297,727

531,519

333,429

Total assets

348,863

509,271

320,927

562,906

379,269

Share capital

166,057

165,932

452,543

452,543

56,568

Total equity

279,042

409,737

255,900

498,238

317,281

Investment in property, plant and equipment

1,055

260

2,981

2,583

11,043








Cash Flow Statement






Cash flow from operating activities

(157,747)

(205,870)

(234,637)

(238,148)

(251,158)

Cash flow from investing activities

(1,055)

169,712

(169,778)

(2,658)

(11,011)

Cash flow from financing activities

(3,227)

404,304

(5,948)

440,014

729

Cash and cash equivalents at period end

328,652

496,834

297,727

531,519

333,429








Financial Ratios






Basic and diluted EPS (DKK)

(0.08)

(0.43)

(0.56)

(2.84)

(4.80)

Weighted average number of shares

1,660,353,248

607,511,489

452,542,480

96,707,708

56,443,701

Average number of employees (FTEs)

26

48

52

59

93

Assets/equity

1.25

1.24

1.25

1.13

1.20

 

Fourth Quarter 2013 Highlights

  • Research and development cost were realized at DKK 29.5 million compared to DKK 41.9 million in same period in  2012, and DKK 35.2 million in the previous quarter.
  • Administrative expenses were realized at DKK 6.5 million compared to DKK 10.2 million in same period in 2012, and DKK 6.7 million in the previous quarter.
  • Operating loss amounted to DKK 23.8 million, while net loss was realized at DKK 24.7 million.

Financial Highlights








Quarterly Numbers in DKK




















Q4

Q3

Q2

Q1

Q4

Q3

Q2

Q1



2013

2013

2013

2013

2012

2012

2012

2012



DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000

DKK'000











Income Statement









Revenue

12,206

12,206

6,868

6,868

6,868

-

-

-

Research and development costs

(29,546)

(35,247)

(42,772)

(38,947)

(41,890)

(49,362)

(56,639)

(62,848)

Administrative expenses

(6,457)

(6,703)

(6,834)

(7,777)

(10,235)

(6,961)

(9,462)

(10,231)

Operating loss before restructuring cost

(23,797)

(29,744)

(42,738)

(39,856)

(45,257)

(56,323)

(66,101)

(73,079)

Restructuring cost

-

-

-

-

-

-

(21,462)

-

Operating loss

(23,797)

(29,744)

(42,738)

(39,856)

(45,257)

(56,323)

(87,563)

(73,079)

Net financial income / (expenses)

(1,425)

(4,655)

(2,253)

3,907

(2,302)

993

2,051

(1,592)

Loss before tax

(25,222)

(34,399)

(44,991)

(35,949)

(47,559)

(55,330)

(85,512)

(74,671)

Tax for the period

522

242

241

244

1,034

(223)

(130)

(318)

Net loss for the period

(24,700)

(34,157)

(44,750)

(35,704)

(46,525)

(55,553)

(85,642)

(74,989)











Balance Sheet









Cash and cash equivalents

328,652

380,179

399,743

456,216

496,834

86,683

152,720

213,786

Total assets

348,863

388,982

409,371

465,939

509,271

99,590

167,799

235,187

Share capital

166,057

166,057

166,057

166,057

165,932

45,254

45,254

452,543

Total equity

279,042

302,307

334,686

377,276

409,737

42,103

98,968

182,545

Investment in property,









plant and equipment

1,055

-

-

-

43

-

126

91











Cash Flow Statement









Cash flow from operating activities

(47,417)

(14,040)

(51,165)

(45,125)

(399)

(62,707)

(62,400)

(80,364)

Cash flow from investing activities

(1,055)

-

-

-

56,619

59,486

24,174

29,433

Cash flow from financing activities

(319)

(401)

(2,555)

48

410,149

(3,450)

(1,085)

(1,310)

Cash and cash equivalents









at period end

328,652

380,179

399,743

456,216

496,834

86,683

152,720

213,786











Financial Ratios









Basic and diluted EPS

(0.01)

(0.02)

(0.03)

(0.02)

(0.08)

(0.12)

(0.19)

(0.17)

Weighted average number of shares

1,660,572,426

1,660,572,426

1,660,572,426

1,659,683,537

607,511,489

452,542,480

452,542,480

452,542,480

Average number of employees (FTEs)

23

26

27

29

33

49

55

55

Assets/equity

1.25

1.29

1.22

1.24

1.24

2.37

1.70

1.29

Outlook for 2014
Veloxis is expecting an operating loss of DKK 60 - 90 million compared to the realized operating loss of DKK 136 million in 2013. Net loss is expected to be in the range of DKK 55 - 85 million compared to the net loss of DKK 139 million in 2013. As of 31 December 2013, the Company's cash position equaled DKK 329 million and the Company's 31 December 2014 cash position is expected to be in the range of DKK 230 - 270 million.

The above estimates are subject to possible changes primarily due to the timing of regulatory approvals and associated milestone payments along with variation of clinical activities and fluctuating exchange rates.

Important events following the balance sheet date
On 8 January, Veloxis announced that United States Patent and Trademark Office had issued a Notice of Allowance for U.S. Application Serial Number 13/167,420, a patent which covers the diurnal-independent administration of Envarsus®.

For more information, please contact:

Veloxis Pharmaceuticals A/S




John D. Weinberg

Executive Vice President & CCO

Mobile: +1 732 321 3208

Email: [email protected]  

Johnny Stilou

Executive Vice President & CFO

Phone: + 45 21 227 227

Email: [email protected]

About Envarsus® and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after transplantation. Envarsus® 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 is a specialty pharmaceutical company. The company's lead product candidate is Envarsus® 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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
"Peak 10 is a national cloud data center solutions managed services provider, and part of that is disaster recovery. We see a growing trend in the industry where companies are coming to us looking for assistance in their DR strategy," stated Andrew Cole, Director of Solutions Engineering at Peak 10, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Judith Hurwitz is president and CEO of Hurwitz & Associates, a Needham, Mass., research and consulting firm focused on emerging technology, including big data, cognitive computing and governance. She is co-author of the book Cognitive Computing and Big Data Analytics, published in 2015. Her Cloud Expo session, "What Is the Business Imperative for Cognitive Computing?" is scheduled for Wednesday, June 8, at 8:40 a.m. In it, she puts cognitive computing into perspective with its value to the busin...
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, discussed the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docker c...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
Everyone wants to use containers, but monitoring containers is hard. New ephemeral architecture introduces new challenges in how monitoring tools need to monitor and visualize containers, so your team can make sense of everything. In his session at @DevOpsSummit, David Gildeh, co-founder and CEO of Outlyer, will go through the challenges and show there is light at the end of the tunnel if you use the right tools and understand what you need to be monitoring to successfully use containers in your...
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...