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Veloxis Pharmaceuticals publishes Annual Report 2013

March 5, 2014

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(TM) 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                    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 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


Source: PR Newswire



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