Pharming Group Interim Report on Financial Results for the First Quarter 2018

Pharming Group Interim Report on Financial Results for the First Quarter 2018

PR Newswire

LEIDEN, Netherlands, May 17, 2018

LEIDEN, Netherlands, May 17, 2018 /PRNewswire/ --

93% increase in revenues from product sales and 110% increase in operating profit compared with the First Quarter 2017 

Delivered net profitability for the first time  

Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) presents its (unaudited) financial report for the quarter ended 31 March 2018.

Operational highlights 

Financial highlights  


Chief Executive Officer of Pharming, Sijmen de Vries, commented:  

"The remarkable growth reported in 2017 has continued into 2018 and I am delighted to report our first quarter of net profitability, which is another significant achievement for Pharming. Investment in our commercial team and continued underlying demand for RUCONEST® in the US are driving this growth. We are also seeing good patient retention rates following the stabilization of competitor product supply, which is a testament to the efficacy of RUCONEST®. We are confident that with our increasing patient reach and advancing pipeline, we will be able to continue to deliver significant value to our patients and other stakeholders."  

Commentary 

The first quarter of 2018 was very positive for Pharming. We emerged from the high pressure on production and supply in Q4 2017 when both leading prophylaxis product suppliers in the USA had supply problems (which in one case extended to Europe). This resulted in extra sales and donated product supplies in the end of Q4 2017. As a responsible pharmaceutical partner, we have continued to supply RUCONEST® on prescription (including free supply) to ensure no patients were left without a C1 esterase inhibitor product where this was prescribed by their physician. These patients have been able to see for themselves the reliability, safety and effectiveness of RUCONEST®. As a testament to its efficacy, many have continued on RUCONEST® therapy despite the stabilisation of the crisis in supplies of the blood plasma-derived products in December 2017. We continue to make good progress in growth in the treatment of acute hereditary angioedema (HAE) attacks.  As a result, sales in the US were ahead of the last quarter ($34.3 million compared with $33.8 million for Q4 2017). Importantly, this strong sales performance resulted in Pharming recording a net profit for the quarter for the first time.  

Pharming is investing to improve the convenience of RUCONEST® administration further. Our R&D scientists have developed new forms of RUCONEST® to take into clinical trials to demonstrate effectiveness for intra-muscular and sub-cutaneous administration of smaller injections and other more convenient applications of RUCONEST® soon.  

We mentioned at our 2017 full year results that we are examining additional indications for RUCONEST®, and the purpose of the 21 June Capital Markets Briefing is to give clear details of progress with RUCONEST ® in HAE and of prospects for these new indications, including contributions from leading physicians in the relevant specialties, with explanations of why we believe RUCONEST® could provide all or part of the solutions to these currently unmet medical needs. We will also be setting out our clinical plans and timelines for the studies involved as well as providing an update on our Pompe disease pipeline programme.

We also record and report our results in US dollars for the first time, with the statements shown in US dollars on pages 10-12 below.

We look forward with confidence to continuing growth of Pharming in the rest of 2018, with increased sales, a new and very exciting pipeline, and new opportunities to enhance shareholder value.

    Financial summary - Euros
    3 months to 31 March
   
                                                   
    Amounts in EURm except per share data   2018      2017        %
                                                               Change

    Income Statement                        29.3      15.2       93%
    Revenue from product sales               0.2       0.3     (33%)
    Other revenue                           29.5      15.5       90%
    Total revenue                           24.5      13.8       78%
    Gross profit                             8.2       3.9      110%
    Operating result                         3.3     (5.7)      158%
    Net result                              
    Balance Sheet                           59.8      27.6      117%
    Cash & marketable securities           
    Share Information                      0.006   (0.012)      150%
    Earnings per share before dilution(EUR) 

Outlook 

For the remainder of 2018, the Company expects:

No further financial guidance for 2018 is provided.

About Pharming Group N.V. 

Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. Pharming's lead product, RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of acute Hereditary Angioedema ("HAE") attacks in patients in Europe, the US, Israel and South Korea. The product is available on a named-patient basis in other territories where it has not yet obtained marketing authorization.

RUCONEST® is distributed by Pharming in Austria, France, Germany, Luxembourg, the Netherlands, the United Kingdom and the United States of America. Pharming holds commercialisation rights in Algeria, Andorra, Bahrain, Belgium, Ireland, Jordan, Kuwait, Lebanon, Morocco, Oman, Portugal, Qatar, Syria, Spain, Switzerland, Tunisia, United Arab Emirates and Yemen. In some of these countries this is done in association with the HAEi Global Access Program (GAP).

RUCONEST® is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine.

RUCONEST® is distributed in Argentina, Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Megapharm.

RUCONEST® is also being examined for approval for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications.

Pharming's technology platform includes a unique, GMP-compliant, validated process for the production of pure recombinant human proteins that has proven capable of producing industrial quantities of high quality recombinant human proteins in a more economical and less immunogenetic way compared with current cell-line based methods. Leads for enzyme replacement therapy ("ERT") for Pompe and Fabry's diseases are being optimized at present, with additional programs not involving ERT also being explored at an early stage at present.

Pharming has a long term partnership with the China State Institute of Pharmaceutical Industry ("CSIPI"), a Sinopharm company, for joint global development of new products, starting with recombinant human Factor VIII for the treatment of Haemophilia A. Pre-clinical development and manufacturing will take place to global standards at CSIPI and are funded by CSIPI. Clinical development will be shared between the partners with each partner taking the costs for their territories under the partnership.

Pharming has declared that the Netherlands is its "Home Member State" pursuant to the amended article 5:25a paragraph 2 of the Dutch Financial Supervision Act.

Additional information is available on the Pharming website: http://www.pharming.com

Forward-looking Statements 

This press release of Pharming Group N.V. and its subsidiaries ("Pharming", the "Company" or the "Group") may contain forward-looking statements including without limitation those regarding Pharming's financial projections, market expectations, developments, partnerships, plans, strategies and capital expenditures. 

The Company cautions that such forward-looking statements may involve certain risks and uncertainties, and actual results may differ. Risks and uncertainties include without limitation the effect of competitive, political and economic factors, legal claims, the Company's ability to protect intellectual property, fluctuations in exchange and interest rates, changes in taxation laws or rates, changes in legislation or accountancy practices and the Company's ability to identify, develop and successfully commercialize new products, markets or technologies. 

As a result, the Company's actual performance, position and financial results and statements may differ materially from the plans, goals and expectations set forth in such forward-looking statements. The Company assumes no obligation to update any forward-looking statements or information, which should be taken as of their respective dates of issue, unless required by laws or regulations. 



    Consolidated Statement of Income
    For the period, in Euros:
                                                                         Q1            Q1
                                                                        2018          2017

    Amounts in EUR '000                                              
    Product sales                                                     29,281        15,192
    License fees                                                         202           268
    Revenues                                                          29,483        15,460

    Costs of sales                                                   (5,022)       (1,697)

    Gross profit                                                      24,461        13,763

    Other income                                                         149            84

     Research and development                                         (5,737)       (4,689)
    General and administrative                                       (2,463)       (1,375)
    Marketing and sales                                              (8,205)       (3,911)
     Costs                                                           (16,405)       (9,975)

    Operating result                                                   8,205         3,872

     Fair value gain (loss) on revaluation derivatives                  (961)       (2,426)
     Other financial income and expenses                              (3,121)       (7,194)
    Financial income and expenses                                    (4,082)       (9,620)

     Result before income tax                                           4,123       (5,748)

    Income tax credit/(expense)                                        (796)            -

    Net result for the year                                            3,327       (5,748)
    Attributable to:
    Owners of the parent                                               3,327       (5,748)
     Total net result                                                   3,327       (5,748)
    Basic earnings per share (EUR)                                     0.006       (0.012)



    Consolidated Statement of Comprehensive Income
    For the period, in Euros
   
                                                           Q1         Q1
                                                          2018       2017
    Amounts in EUR '000
    Net result for the year                               3,327     (5,748)
    Currency translation differences                    (1,423)        (20)
    Items that may be subsequently reclassified to
    profit or loss                                      (1,423)        (20)
    Other comprehensive income, net of tax              (1,423)        (20)
    Total comprehensive income for the year               1,904     (5,768)
    Attributable to:                                      1,904     (5,768)
    Owners of the parent                               


    Consolidated Balance Sheet
    As at date shown, in Euros
   
                                               31 March   31 December
    Amounts in EUR '000                          2018          2017
    Non-current assets
    Intangible assets                           56,272        56,631
    Property, plant and equipment                7,970         8,234
    Long-term prepayments                        2,116         2,296
    Restricted cash                              1,305         1,336
    Deferred tax asset                           8,581         9,442
    Total non-current assets                    76,244        77,939

    Current assets
    Inventories                                 21,611        18,334
    Trade and other receivables                 14,370        11,260
    Cash and cash equivalents                   58,456        58,657
    Total current assets                        94,437        88,251

    Total assets                               170,681       166,190

    Equity
    Share capital                                6,017         5,790
    Share premium                              381,042       370,220
    Legal reserves                             (2,361)         (938)
    Accumulated deficit                      (353,091)     (356,270)
    Shareholders' equity                        31,607        18,802
    Non-current liabilities
    Loans and borrowings                        50,089        58,684
    Deferred license fees income                 1,267         1,467
    Finance lease liabilities                      279           390
    Other financial liabilities                 28,319        28,319
    Total non-current liabilities               79,954        88,860
    Current liabilities
    Loans and borrowings                        27,945        21,962
    Deferred license fees income                   802           804
    Derivative financial liabilities             1,125         8,301
    Trade and other payables                    28,968        27,198
    Finance lease liabilities                      280           263
    Total current liabilities                   59,120        58,528

    Total equity and liabilities               170,681       166,190


    Consolidated Statement of Cash Flows
    For the period, in Euros
   
                                                                Q1          Q1

    Amounts in EUR'000                                         2018        2017
    Operating result                                          8,205       3,872
    Non-cash adjustments:
    Depreciation, amortization                                  944         839
    Accrued employee benefits                                   458         564
    Deferred license fees                                     (202)       (268)
    Operating cash flows before changes in working
    capital                                                   9,405       5,007
    Changes in working capital:
    Inventories                                             (3,277)       (960)
    Trade and other receivables                             (3,110)    (11,221)
    Payables and other current liabilities                  (4,684)       2,828
    Total changes in working capital                       (11,071)     (9,353)
    Changes in non-current assets, liabilities and
    equity                                                      705       (581)
    Cash generated from (used in) operations before
    interest and taxes                                        (961)     (4,927)
    Interest received                                             -           -
    Net cash flows generated from (used in) operating
    activities                                                (961)     (4,927)
    Capital expenditure for property, plant and
    equipment                                                 (517)       (654)
    Investment intangible assets                              (353)       (180)
    Net cash flows generated from (used in) investing
    activities                                                (870)       (834)
    Proceeds of loans and borrowings                              -       4,444
    Redemption on bonds                                     (2,238)     (2,413)
    Interest on loans                                       (2,592)       (775)
    Proceeds of equity and warrants                           6,556          -
    Net cash flows generated from (used in) financing
    activities                                                1,726       1,256
    Increase (decrease) of cash                               (105)     (4,505)
    Exchange rate effects                                     (127)        (26)
    Cash and cash equivalents at 1 January                   59,993      32,137
    Total cash and cash equivalents at 31 March              59,761      27,606



                           US Dollar Statements
Consolidated Statement of Income  
For the period, in US dollars
   
                                                      Q1            Q1
    Amounts in $ '000                                2018          2017
    Product sales                                   35,934        16,169
    License fees                                       248           285
    Revenues                                        36,182        16,454

    Costs of sales                                 (6,163)       (1,806)

    Gross profit                                    30,019        14,648

    Other income                                       183            89

    Research and development                       (7,040)       (4,991)
    General and administrative                     (3,022)       (1,463)
    Marketing and sales                           (10,070)       (4,162)
    Costs                                         (20,132)      (10,616)

    Operating result                                10,070         4,121

    Fair value gain (loss) on
    revaluation derivatives                        (1,179)       (2,582)
    Other financial income and expenses            (3,813)       (7,681)
    Financial income and expenses                  (4,992)      (10,263)

    Result before income tax                         5,078       (6,142)

    Income tax credit/(expense)                      (977)            -

    Net result for the year                          4,101       (6,142)
    Attributable to:
    Owners of the parent                             4,101       (6,142)
    Total net result                                 4,101       (6,142)
    Basic earnings per share ($)                     0.006       (0.012)
Please note the 2017 figures are estimates for information only, and are not  presented as
 true comparable figures at this stage.

   

    

Consolidated Balance Sheet  
As at date shown, in US dollars
   
                                               31 March   31 December
    Amounts in $ '000                            2018          2017
    Non-current assets
    Intangible assets                           69,361        67,827
    Property, plant and equipment                9,824         9,862
    Long-term prepayments                        2,608         2,749
    Restricted cash                              1,608         1,600
    Deferred tax asset                          10,578        11,309
    Total non-current assets                    93,979        93,347

    Current assets
    Inventories                                 26,638        21,958
    Trade and other receivables                 17,712        13,487
    Cash and cash equivalents                   72,052        70,254
    Total current assets                       116,402       105,699

    Total assets                               210,381       199,046

    Equity
    Share capital                                7,416         6,935
    Share premium                              469,673       443,412
    Legal reserves                              (2,911)       (1,124)
    Accumulated deficit                       (435,220)     (426,703)
    Shareholders' equity                        38,958        22,520
    Non-current liabilities
    Loans and borrowings                        61,740        70,286
    Deferred license fees income                 1,561         1,757
    Finance lease liabilities                      344           467
    Other financial liabilities                 34,906        33,918
    Total non-current liabilities               98,551       106,428
    Current liabilities
    Loans and borrowings                        34,445        26,304
    Deferred license fees income                   988           962
    Derivative financial liabilities             1,387         9,942
    Trade and other payables                    35,707        32,575
    Finance lease liabilities                      345           315
    Total current liabilities                   72,872        70,098

    Total equity and liabilities               210,381       199,046
Please note the 2017 figures are estimates for information only, and are not presented as
true comparable figures at this stage.




Consolidated Statement of Cash Flows
For the period, in US dollars
   
                                                                Q1          Q1

    Amounts in $'000                                           2018        2017
    Operating result                                         10,070       4,121
    Non-cash adjustments:
    Depreciation, amortization                                1,158         893
    Accrued employee benefits                                   562         600
    Deferred license fees                                     (248)       (285)
    Operating cash flows before changes in working
    capital                                                  11,542       5,329
    Changes in working capital:
    Inventories                                              (4,680)     (1,259)
    Trade and other receivables                              (4,225)    (12,410)
    Payables and other current liabilities                   (4,824)      3,146
    Total changes in working capital                        (13,729)    (10,523)
    Changes in non-current assets, liabilities and
    equity                                                      865       (618)
    Cash generated from (used in) operations before
    interest and taxes                                       (1,322)     (5,812)
    Interest received                                             -           -
    Net cash flows generated from (used in) operating
    activities                                               (1,322)    (5,812)
    Capital expenditure for property, plant and
    equipment                                                 (634)       (696)
    Investment intangible assets                              (433)       (192)
    Net cash flows generated from (used in) investing
    activities                                               (1,067)      (888)
    Proceeds of loans and borrowings                              -      5,000
    Redemption on bonds                                      (2,744)    (2,568)
    Interest on loans                                        (3,186)      (825)
    Proceeds of equity and warrants                           8,081           -
    Net cash flows generated from (used in) financing
    activities                                                2,151      1,607
    Increase (decrease) of cash                               (238)     (5,093)
    Exchange rate effects                                   (1,569)         670
    Cash and cash equivalents at 1 January                   71,854      33,920
    Total cash and cash equivalents at 31 March              73,661      29,497
Please note the 2017 figures are estimates for information only, and are not presented as                                
true comparable figures at this stage.


Contacts: 
Pharming Group N.V. 
Sijmen de Vries, CEO
Tel:+31-71-524-7400

Robin Wright, CFO
Tel:+31-71-524-7432

FTI Consulting: 
Julia Phillips/Victoria Foster Mitchell
Tel:+44-203-727-1136

Lifespring Life Sciences Communication 
Leon Melens
Tel:+31-6-53-81-64-27

 

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