Pharming Reports on Financial Results for the First Nine Months of 2014

FINANCIAL RESULTS 

In the first nine months of 2014, the Company generated revenue from sales of Ruconest® of €2.2 million (9M 2013: €0.6 million). The increase in revenue from sales reflects the underlying increased demands for Ruconest® in the EU markets, compared to 9M 2013. Costs of revenues amounted to €2.6 million (2013: €0.4) including impairments of inventories amounting to €0.5 million. Licensing fees decreased to €1.6 million (9M 2013: €5.4 million) as a result of last year's receipt of a US$5 million payment by our US partner Santarus (now Salix Pharmaceuticals: NASDAQ: SLXP "Salix").

Loss from operating activities increased to €9.7 million (9M 2013 €3.7 million), predominantly as a result of the receipt of the one- off milestone payment of US$5 million in 2013, the increase of operating costs and a €0.5 million impairment on inventory, reflecting the current low yield on EU sales.

Financial income and expenses increased to €9.2 million (9M 2013: €7.4 million), as a result of the (non-cash) increase of the fair value of our outstanding warrants, reflecting the increase of our share price in 9M 2014; while the 9M 2013 costs were related to the January 2013 €16.35 million convertible bond.

As a result of the above items, the net loss for the first nine months of 2014 increased to €18.9 million from €11.1 million in the same period of 2013.

Cash outflows from operations increased by €6.6 million to €13.7 million in 3Q 2014 (9M 2013: €7.1 million), mainly as a result of the increase in manufacturing activities for Ruconest®, ahead of the anticipated US launch in 4Q 2014.

FINANCIAL POSITION 

Total cash and cash equivalents (including restricted cash) increased to €23.8 million at 30 September 2014 from €19.2 million at year end 2013. The increase is a result of net cash outflows from operations of €13.7 million and €0.5 million used in investing activities, with net cash inflows from financing activities amounting to €19.4 million and net cash outflows from financing activities amounting to €0.6 million.

Financing cash inflows mainly result from the proceeds of the private equity placement of €14.7 million in April 2014 and the exercise of (2012 and 2013) warrants during 9M 2014, which yielded €4.7 million in cash.

EQUITY POSITION 

The equity position increased by €10.9 million versus year-end 2013 (€5.0 million) to €15.9 million (9M 2013: €1.6 million negative).

Pharming continues to monitor the development of its equity standing under International Financial Reporting Standards (IFRS). Notably, the Company reports that the negative equity position at the end of 2011 was mainly caused by the inability to recognize the €19.7 million upfront payments and milestones received from Sobi and Santarus as equity (at 30 September 2014 the deferred license fees income amounted to €12.8 million).

The number of outstanding shares as of 30 October 2014 is 407,686,599 and the fully diluted number of shares is 475.9 million

FINANCIAL GUIDANCE 2014 

As result of the continuing regulatory review process in Turkey, the prevailing unrest in Israel and the announcement of direct commercialization by Pharming in Austria, Germany and Netherlands, revenues from Ruconest® sales for 2014 (not including US sales) are now expected to increase from €1.0 million in 2013 to €2.8 million, instead of the previously expected €3.0 million.

No additional financial guidance is provided.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in the USA, Israel, all 27 EU countries plus Norway, Iceland and Liechtenstein. Ruconest® is commercialized by Pharming in Austria, Germany and Netherlands. 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 partnered with Salix Pharmaceuticals Inc. (NASDAQ: SLXP) in North America.

Ruconest® is also being investigated in a randomized Phase II clinical trial for prophylaxis of HAE and evaluated for various additional follow-on indications. Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell based technologies. Leads for enzyme replacement therapy in Pompe's, Fabry's and Gaucher's diseases are under early evaluation.The platform is partnered with Shanghai Institute for Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre- clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilize this platform for the development of rh-FVIII for the treatment of Haemophilia-A. Additional information is available on the Pharming website; http://www.pharming.com.

This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.  

PHARMING GROUP N.V. 

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS  

FOR THE NINE MONTHS ENDED 30 SEPTEMBER 2014 

Consolidated Statement of Financial Position

Consolidated Statement of Income

Consolidated Statement of Comprehensive Income

Consolidated Statement of Cash Flows

Consolidated Statement of Changes in Equity

Notes to the Condensed Consolidated Interim Financial Statements

CONSOLIDATED STATEMENT OF FINANCIAL POSITION  

At 30 September 2014 (unaudited - amounts in €'000) 

   
                                           30 September  31 December
                                                   2014         2013

    Intangible assets                              321          405
    Property, plant and equipment       5        5,776        6,228
    Restricted cash                     8          176          176
    Non-current assets                           6,273        6,809

    Inventories                         6        9,191        4,763
    Trade and other receivables         7        1,667          860
    Restricted cash                     8            -        2,008
    Cash and cash equivalents           8       23,632       16,968
    Current assets                              34,490       24,599

    Total assets                                40,763       31,408

    Share capital                                4,077        3,346
    Share premium                              282,261      254,901
    Other reserves                              16.525       14,874
    Accumulated deficit                      (286,982)    (268,111)
    Total equity                        9       15,881        5,010

    Deferred license fees income                10,572       12,222
    Finance lease liabilities                    1,076        1,207
    Other liabilities                               22           44
    Non-current liabilities                     11,670       13,473

    Deferred license fees income                 2,200        2,200
    Derivative financial liabilities   10        4,682        4,147
    Trade and other payables           11        5,868        5,812
    Finance lease liabilities                      462          766
    Current liabilities                         13,212       12,925

    Total equity and liabilities                40,763       31,408

Notes on pages 11-15 are an integral part of these condensed consolidated interim financial statements.

CONSOLIDATED STATEMENT OF INCOME 

For the nine months ended 30 September 2014 (unaudited - amounts in €'000, except per share data) 

   
                                                   30 September 30 September
                                            Note         2014         2013

    Continuing operations:

    License fees                                         1,650        5,353
    Product sales                                        2,193          614
    Revenues                                             3,843        5,967
    Costs of product sales                             (2,189)        (419)
    Inventory impairments                                (474)            -
    Gross profit                                         1,180        5,548

    Income from grants                                      92           79
    Other income                                            92           79

    Research and development                           (9,165)      (7,554)
    General and administrative                         (1,770)      (1,754)
    Costs                                             (10,935)      (9,308)

    Result from operating activities           12      (9,663)      (3,681)

    Financial income                           13          144          588
    Financial expenses                         14      (9,352)      (8,002)
    Financial income and expenses                      (9,208)      (7,414)

    Net result from continuing operations             (18,871)     (11,095)

    Attributable to:
    Net result from continuing operations             (18,871)     (11,095)
    Owners of the parent                              (18,871)     (11,095)

    Share information:
    Basic and diluted net loss per share
    (EUR)                                               (0.05)       (0.06)
    Weighted average shares outstanding            388,245,868  175,368,600

Notes on pages 11-15 are an integral part of these condensed consolidated interim financial statements.

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME  

For the nine months ended 30 September 2014 (unaudited - amounts in €'000) 

   
                                                   30 September 30 September
                                                           2014         2013

    Net result                                         (18,871)     (11,095)

    Currency translation differences                          -            -
    Items that will be subsequently reclassified
    to profit or loss                                         -            -

    Other comprehensive income, net of tax                    -            -

    Total comprehensive income                         (18,871)     (11,095)

    Attributable to:
    Equity owners of the parent                        (18,871)     (11,095)

Notes on pages11-15 are an integral part of these condensed consolidated interim financial statements.

CONSOLIDATED STATEMENT OF CASH FLOWS  

For the nine months ended 30 September 2014 (unaudited - amounts in €'000) 

   
                                                            30 September 30 September
                                                       Note         2014         2013

    Receipts from license partners                                 1,651        4,804
    Receipts of Value Added Tax                                      712          572
    Interest received                                                136            6
    Other receipts                                                   283          848
    Payments of third party fees and expenses,
    including Value Added Tax                                    (5,471)      (8,708)
    Payments of third party manufacturing expenses               (7,684)        (347)
    Net compensation paid to board members and
    employees                                                    (1,707)      (1,460)
    Payments of pension premiums, payroll taxes and
    social securities, net of grants settled                     (1,604)      (1,585)
    Restructuring payments                                             -      (1,245)
    Net cash flows used in operating activities           8     (13,684)      (7,115)

    Proceeds from sale of assets                                       -          262
    Purchase of property, plant and equipment                      (500)         (21)
    Net cash flows provided by/(used in) investing
    activities                                            8        (500)          241

    Proceeds of convertible bonds issued                               -       16,023
    Proceeds of equity and warrants issued                        19,375            -
    Payments of transaction fees and expenses                      (697)      (1,368)
    Payments of finance lease liabilities                          (139)        (478)
    Net cash flows from financing activities              8       18,539       14,177

    Increase cash                                                  4,355        7,303
    Exchange rate effects on cash                                    301        (123)
    Cash at 1 January                                     8       19,152        6,314
    Cash at 30 September                                          23,808       13,494

    Cash composition:
    Restricted cash (non-current)                                    176          176
    Restricted cash (current)                                          -          618
    Cash and cash equivalents                                     23,632       12,700
    Cash at 30 September                                          23,808       13,494

Notes on pages 11-15 are an integral part of these condensed consolidated interim financial statements.

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY  

For the nine months ended 30 September 2014 (unaudited - amounts in €'000) 

   
                                                                  Accu-     Share-
                            Number    Share   Share    Other      mulated   holders' Total
                  Note   of shares  capital premium reserves      deficit   equity   equity

    Balance at 1
    January 2013       100,918,910   10,092 231,866   14,144    (263,754)  (7,652)  (7,652)
    Loss for the
    period                       -        -       -        -     (11,095) (11,095) (11,095)
    Other
    comprehensive
    income for
    the period                   -        -       -        -            -        -        -
    Total
    comprehensive
    income for
    the period                   -        -       -        -     (11,095) (11,095) (11,095)
    Share-based
    compensation                 -        -       -      224            -      224      224
    Bonuses
    settled in
    shares           9   1,281,777       12     176        -            -      188      188
    Repayments of
    bonds 2013       9 127,369,529    2,896  13,824        -            -   16,720   16,720
    Warrants
    exercised              300,000        3      19        -            -       22       22
    Adjustment
    nominal value
    per share                    - (10,704)       -        -       10,704        -        -
    Total
    transactions
    with owners,
    recognized
    directly in
    equity             128,951,306  (7,793)  14,019      224       10,704   17,154   17,154

    Balance at 30
    September
    2013               229,870,216    2,299 245,885   14,368    (264,145)  (1,593)  (1,593)

    Balance at 1
    January 2014       334,655,224    3,346 254,901   14,874    (268,111)    5,010    5,010
    Loss for the
    period                       -        -       -        -     (18,871) (18,871) (18,871)
    Other
    comprehensive
    income for
    the period                   -        -       -        -            -        -        -
    Total
    comprehensive
    income for
    the period                   -        -       -        -     (18,871) (18,871) (18,871)
    Share-based
    compensation                 -        -       -    1,651            -    1,651    1,651
    Bonuses
    settled in
    shares
                           963,066       10     440        -            -      450      450
    Shares issued
    for cash         9  30,000,000      300  13,704        -            -   14,004   14,004
    Warrants
    exercised/
    issued           9  42,012,059      420  13,213        -            -   13,633   13,633
    Options
    exercised               56,250        1       3        -            -        4        4
    Total
    transactions
    with owners,
    recognized
    directly in
    equity              73,031,375      731  27,360    1,651            -   29,742   29,742

    Balance at 30
    September
    2014               407,686,599    4,077 282,261   16,525    (286,982)   15,881   15,881

Notes on pages 11-15 are an integral part of these condensed consolidated interim financial statements.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 

For the nine months ended 30 September 2014 

1.     Company information 

Pharming Group N.V. ('Pharming' or 'the Company') is a limited liability public company which is listed on NYSE Euronext Amsterdam, with its headquarters and registered office located at:

Darwinweg 24

2333 CR Leiden

The Netherlands

Pharming focuses on the development, production and commercialization of human therapeutic proteins to be used as highly innovative therapies. The Company's products are aimed at treatments for genetic disorders and surgical and traumatic bleeding. Pharming's technologies include novel transgenic platforms for the production of biopharmaceuticals, as well as technology and processes for the purification and formulation of these biopharmaceuticals.

2.     Basis of presentation 

These condensed consolidated interim financial statements do not include all of the information required for full annual financial statements and should be read in conjunction with Pharming's Annual Report 2013. In addition, the notes to these condensed consolidated interim financial statements are presented in a condensed format.

These condensed consolidated interim financial statements have not been reviewed or audited. The Board of Management has approved these condensed consolidated interim financial statements on 29 October 2014.

Going Concern Assessment 

The Board of Management of Pharming has, upon preparing and finalizing these financial statements, assessed the Company's ability to fund its operations for a period of at least one year after the date of signing these financial statements.

Based on the above assessment, the Company has concluded that funding of its operations for a period of well in excess of one year after the date of the signing of these financial statements is realistic and achievable. In arriving at this conclusion, the following main items and assumptions have been taken into account:

• cash and cash equivalents of approximately €22.9 million as per the date of these financial statements (30 October 2014);
• the projected, however undisclosed sales revenues for the period involved, related to the markets in which the Company already has market approval;
• the Company's operating cash outflows, its investments in (in)tangible assets for one year after the end of the financial statements; The cash outflow is expected to increase as a result of the increase in manufacturing expenses;
• the anticipated receipt of US$20.0 million in cash from our US partner Salix following the recent market approval of Ruconest® by the U.S. FDA

Pharming has not taken into account other potential sources of cash income, including, but not limited to the following:

• proceeds from the exercise of warrants or options outstanding as per the date of these condensed consolidated financial interim statements;
• capital raised by means of an additional capital markets transaction, such as non-dilutive (debt) financing, issuance of equity or a combination thereof.
• other receipts from existing or new license partners.

In addition, the Company may decide to cancel and/or defer certain activities in order to limit cash outflows until sufficient funding is available to resume them. Deferrals substantially relate to the timing of manufacturing-related and/or planned future clinical development activities for additional indications carried out on the initiative of Pharming.

Notwithstanding the above, the Board of Management of the Company emphasizes that the funding of the Company's operations beyond one year after these financial statements is largely affected by its ability to increase product sales and/or license fee payments from both existing and new partnerships to generate positive cash flows in the future.

With regards to its ability to generate operating cash flows from product sales and/or license fee payments, the following uncertainties (individually or combined) have been identified:

• the commercial success of Ruconest® in the US,
• the commercial success of Ruconest® in the EU.

Overall, based on the outcome of this assessment, these financial statements have been prepared on a going concern basis. Notwithstanding their belief and confidence that Pharming will be able to continue as a going concern, the Board of Management emphasizes that the actual cash flows for various reasons may ultimately (significantly) deviate from their projections. Therefore, in a negative scenario (actual cash inflows less than projected and/or actual cash outflows higher than projected) the going concern of the Company could be at risk in the period beyond 12 months as per the date of these financial statements.

3.     Summary of significant accounting policies 

The applied accounting principles are consistent with those as described in Pharming's Annual Report 2013.

Significant accounting estimates and judgments 

The preparation of financial statements requires judgments and estimates that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities at the date of the condensed consolidated interim financial statements. The resulting accounting estimates will, by definition, seldom equal the actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amount of assets and liabilities within the next financial year are addressed below.

Property, plant and equipment 

At the end of the first nine months of 2014, Pharming has property, plant and equipment with a net carrying value of €5.8 million. These assets are dedicated to the production of Ruconest® inventories (€4.6 million) and other corporate purposes (€1.2 million). It is assumed these asset groups will continue to be used in ongoing production, research and development or general and administrative activities over its anticipated lifetime.

Inventories 

At the end of the first nine months of 2014, the Company has capitalized Ruconest® product and milk with an aggregate net carrying value of €9.2 million.

The Company has planned for additional inventory investments after the end of the reporting period. These inventories are available for use in commercial, preclinical and clinical activities.

Estimates have been made with respect to the ultimate use or sale of the product, taking into account current and expected preclinical and clinical programs for both the HAE project and other indications of Ruconest® as well as sales projections. In doing so, best estimates have been made with respect to the timing of such events in view of both the existing and expected lifetimes of the product involved.

Due to the early stage commercialization cycle of Ruconest® the actual cash proceeds from these product sales are currently difficult to predict in terms of volumes, timing and reimbursement amounts. In addition, further inventory investments and execution of pre-clinical and clinical activities are subject to availability of sufficient financial resources.

Derivative financial liabilities 

At 30 September 2014, the Company has presented derivative financial liabilities with a carrying value of €4.7 million. These liabilities primarily represent the fair values of warrants issued. These fair values are based on models using assumptions with respect to, amongst others, the exercise of the warrants on or before maturity dates as well as (historical) volatility. Actual share price developments may trigger exercise of these warrants on a different moment than anticipated in the model and also cause transfer of assets to warrant holders under conditions that are (much) more or (much) less favorable than anticipated at 30 September 2014. As a result, the difference between the value of assets transferred to warrant right holders upon exercise and the carrying value at 30 September 2014 as charged to the statement of income may be material.

Share price developments may also result in the warrants expiring unexercised while the fair value of warrants unexercised may fluctuate (significantly) until expiration. Fair value changes of warrant rights unexercised between 30 September 2014 and subsequent reporting dates are charged to the statement of income.

4.     Cyclicality 

In view of the Company's line of business, revenues and cash income from operating activities are subject to the timing of entering into commercial activities as well as the underlying mechanisms of the deal structure (e.g. achievement of milestones). Expenses incurred for research and development activities as well as their associated cash flows highly depend on the phase of research or development. Such items may vary significantly from period to period (i.e. from quarter to quarter) due to the timing and extent of commercial activities as well as research and development activities and are partially beyond control of the Company.

5.     Property, plant and equipment 

The carrying value of Pharming's property, plant decreased from €6.2 million at year end 2013 to €5.8 million at 30 September 2014 due to depreciation of these assets.

6.     Inventories 

Pharming's inventories increased from €4.8 million at 31 December 2013 to €9.2 million at 30 September 2014.

7.     Trade and other receivables 

The increase of trade and other receivables to €1.7 million at 30 September 2014 from €0.9 million at 31 December 2013 mainly results from an increase in trade receivables of €0.3 million and other receivables of €0.5 million related to the investing activities.

8.     Restricted cash, cash and cash equivalents, cash flows 

The overall net cash position for the first nine months ended 30 September 2014 and 30 September 2013 is as follows:

   
                                            30 September 30 September
     Amounts in EUR'000                             2014         2013

    Non-current restricted cash                      176          176
    Current restricted cash                            -          618
    Cash and cash equivalents                     23,632       12,700
    Balance at 30 September                       23,808       13,494
    Balance at 1 January                          19,152        6,314
    Increase for the period                        4,656        7,180

Restricted cash represent the value of banker's guarantees issued with respect to (potential) commitments towards third parties and are primarily related to the rent of the Company's offices.

The main cash flow items for the first nine months of 2014 and 2013 can be summarized as follows:

   
                                                       30 September 30 September
    Amounts in EUR'000                                         2014         2013

    Net cash flows used in operating activities            (13,684)      (7,115)
    Net cash flows provided by/(used in) investing
    activities                                                (500)          241
    Net cash flows from financing activities                 18,539       14,177
    Exchange rate effects on cash                               301        (123)
    increase for the period                                   4,656        7,180

Cash flows used in operating activities increased by €6.6 million, which is entirely related to the increase of third party manufacturing expenses, regarding the build-up of Ruconest® inventories.

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