LEIDEN, Netherlands, May 17, 2017 /PRNewswire/ --
Operating profitability achieved, with a 794% increase in revenues from product sales, demonstrating the benefits of reacquiring RUCONEST(R) commercialisation rights in the US
Pharming Group N.V. ("Pharming" or "the Company") presents its (unaudited) financial report for the quarter ended 31 March 2017.
- Strategic decision to reacquire commercial rights to sell RUCONEST(R) in North
America accelerated the delivery of operating profitability
- On track with investment in US commercialization team
- On schedule to complete transition of services from Valeant Pharmaceuticals
International, Inc. in the second quarter
- Positive EMA amendment to the marketing authorization in Europe to allow
self-administration of RUCONEST(R) for HAE attacks with a new custom-designed RUCONEST
(R) Administration Kit
- Net product sales increased by 794% to EUR15.2 million (2016: EUR1.7 million),
mainly as a result of the combined effect of receiving all of the revenue from US
product sales instead of the previous 30% supply share of net sales, as well as a
significant underlying increase of US sales volumes.
- Total revenues increased by 605% to EUR15.5 million (including EUR0.3 million of
license revenue) from EUR2.2 million in 2016 (including EUR0.5 million in license
- Operating results improved to a profit of EUR3.9 million from a loss of EUR3.2 million
in 2016, and a loss of EUR11.5 million over the whole of 2016, despite a considerable
increase in commercialization activities, especially in the US
- The net result was a loss of EUR5.7 million, compared with a loss of EUR3.4 million in
2016, mainly as a result of non-cash financing expenses required to be shown under
IFRS associated with the Amortising Convertible Bonds 2017/2018
- The equity position improved from EUR27.5 million in December 2016 to EUR28.9 million
at the end of March 2017, mainly due to the conversion of the early installments of
the Amortizing Convertible Bond into shares and despite the net loss of EUR5.7 million
- Inventories changed from EUR17.9 million in 2016 to EUR18.9 million in 2017, largely
due to the need to cover the improving sales level in the US and to preparation for
the launch of the self-administration kits in Europe, as well as raw materials for the
new forms of RUCONEST(R) in development
- Conversions by some bondholders during the quarter, together with scheduled repayments,
meant that the amount of Amortizing Bonds outstanding prior to the refinance was
reduced from EUR45.0 million to EUR36.6 million. No cash payment was required for the
first installment of the Bonds due on 1 February 2017, only EUR125,000 was required
for the second installment, paid on 1 March 2017, and EUR1.3 million was required for
the third installment, paid on 31 March 2017.
- The Company's cash position decreased from EUR32.1 million at year-end 2016 to EUR27.6
million at 31 March 2017 (EUR27.5 million at 31 March 2016), largely due to delayed
receipt of some trade payments for the quarter, which were received after the quarter
end in April, balanced by the lower-than-expected cash installments paid on the
Amortizing Bonds. If these trade payments had been received during the quarter, the
cash position would have increased, showing positive net cash generation.
Post period highlights
- The refinance of the Company's debt by means of 48 months senior secured debt from
Orbimed Advisors has enabled the Company to recover 115.0 million shares net of new
warrants, which were previously reserved for conversion and/or repayment of the
Amortizing Bonds due in 2018, and has eliminated the need to repay part of these Bonds
in shares at a significant discount to the current market price
- As expected, the refinancing will have a one-time negative impact on the net result
for the second quarter as a result of the costs of the exercise as adjusted by the
reversal of certain IFRS accounting entries in respect of the instruments which were
refinanced. This will be rapidly recovered during the year as the benefits of the
lower cash cost of debt and the recovery of the conversion shares, which could
otherwise have been issued for less than the current market price of the Pharming
shares, are realized
- The refinancing is currently structured as a bridge facility, and is expected to be
replaced by a full facility with Orbimed Advisors within 60 days. The transaction has
had almost no effect on Pharming's cash position as at the reporting date. For more
details see the relevant press release dated Tuesday 16 May 2017 on the Company's
website at http://www.pharming.com
The first quarter was very active for Pharming and importantly, it was the first full quarter in which we received all of the benefits of the acquisition of commercialization rights for RUCONEST(R) in North America from certain subsidiaries of Valeant Pharmaceuticals International, Inc. (Valeant). As part of our rationale for this transformational transaction, we identified the significant impact it would have on accelerating operating profitability for Pharming. As such, I am very happy to report that we have already delivered an operating profit during the first full quarter after the transaction. As mentioned above, we are currently generating cash from operations, and with the new long term financing we expect to continue to do so.
We have invested in additional experienced hereditary angioedema (HAE)/rare disease sales force members, medical science liaison professionals and a very seasoned management team, with expertise in marketing, sales, managed care, reimbursement, commercial activity and patient support, to drive future growth. The result of this will mean higher sales and marketing costs in the rest of the year, but it will also allow full development of RUCONEST(R) sales in the US market, as well as in Europe and other markets where Pharming sells RUCONEST(R) directly.
In February, the European Medicines Agency (EMA) confirmed that the RUCONEST(R) label would be amended, allowing for home treatment by patients themselves, with a custom-designed self-administration kit, which was confirmed by the EMA with the appropriate label adjustment early in 2017. This EU approval of self-administration is further to the US approval received in 2014.
In order to continue to improve the convenience of RUCONEST(R) administration, our R&D scientists have formulated a highly-concentrated vial of RUCONEST(R) with the intention of entering clinical trials with intra-muscular and/or sub-cutaneous administration of smaller injections of RUCONEST(R) within the next twelve months, as well as marketing a much smaller and therefore quicker version for intravenous on-demand use in acute HAE attacks.
After the reporting date, we successfully redeemed our potentially-dilutive Amortizing Convertible Bonds, which were issued during the RUCONEST(R) rights acquisition from Valeant, with a new single debt financing facility on more favourable terms. In order to give the new lenders a charge over the assets of the Company as collateral for the loan, it was also necessary to re-finance the senior loan facility taken out at the same time as the Amortizing Convertible Bonds. Although this transaction was associated with significant one-off costs, it has reduced the fully diluted share capital by 115 million shares and the cost will be more than compensated for by large reductions in both cash payments to debt interest and repayments over the next two years and the (non-cash) IFRS-related financing costs reflecting effective rather than actual interest. This transaction has eliminated the potential for at least 24% dilution in the event that the bonds were converted or repaid in shares. The new debt facility allows us to invest in RUCONEST(R) commercialization and pipeline development further to accelerate sales activity.
I look forward with confidence to continuing growth of Pharming in the rest of 2017, with increased sales, an exciting pipeline and new opportunities to enhance shareholder value.
3 months to 31 March
2017 2016 %
Amounts in EURm except per share data Change
Revenue from product sales 15.2 1.7 794%
Other revenue 0.3 0.5 (67%)
Total revenue 15.5 2.2 605%
Gross profit 13.8 1.6 763%
Operating result 3.9 (3.2) 222%
Net result (5.7) (3.4) (68%)
Cash & marketable securities 27.6 27.7 (0%)
Earnings per share before dilution
(EUR) (0.012) (0.008) (50)%
For the remainder of 2017, the Company expects:
- Continued growth in revenues from sales of RUCONEST(R), mainly driven by the US
- Achievement of positive quarterly Operating Results in the course of the year.
- Continued investment in the production of RUCONEST(R) in order to ensure continuity of
supply to the growing markets in the US, Europe and the rest of the world
- Investment in the approval or further clinical trial development for RUCONEST(R) in
prophylaxis of HAE and the development of a small, fast IV version and new
intramuscular and subcutaneous versions of RUCONEST(R)
- We will also continue to invest carefully in the new pipeline programs in Pompe
disease and Fabry's disease, and additional development opportunities and assets as
- Increasing marketing activity where profitable for Pharming, such as in our current
major territories of the US, Austria, France, Germany, the UK and the Netherlands
- We will continue to support patients in all territories, as we continue to believe
that RUCONEST(R) represents the fastest, most effective, most reliable and safest
therapy option available to HAE patients
No further financial guidance for 2017 is provided.
Although the requirement to produce quarterly reports has been discontinued under the new EU Transparency Directive and the Amended Transparency Directive Implementation Act, Pharming intends to continue to provide quarterly operating and financial reports on a voluntary basis.
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(R) (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(R) is commercialized by Pharming in Algeria, Andorra, Austria, Bahrain, Belgium, France, Germany, Ireland, Jordan, Kuwait, Lebanon, Luxembourg, Morocco, the Netherlands, Oman, Portugal, Qatar, Syria, Spain, Switzerland, Tunisia, the United Arab Emirates, the United Kingdom, the United States of America and Yemen.
RUCONEST(R) 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(R) 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(R) is also being investigated in a Phase II clinical trial 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 Pompé 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
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 first quarter ended 31 March
Amounts in EUR'000, except per share data 2017 2016
Product sales 15,192 1,662
Amortised License fee income 268 552
Revenues 15,460 2,214
Costs of product sales (1,705) (657)
Inventory impairments 8 -
Costs of sales (1,697) (657)
Gross profit 13,763 1,557
Other income 84 126
Research and development (4,689) (3,695)
General and administrative (1,375) (941)
Marketing and sales (3,911) (217)
Costs (9,975) (4,853)
Operating result 3,872 (3,170)
Fair value gain/(loss) on revaluation
derivatives (2,426) 367
Other financial income and expenses (7,194) (582)
Financial income and expenses (9,620) (215)
Result before income tax (5,748) (3,385)
Income tax expense - -
Net result for the year (5,748) (3,385)
Owners of the parent (5,748) (3,385)
Total net result (5,748) (3,385)
Basic earnings per share (EUR) from
continuing operations (0.012) (0.008)
CONSOLIDATED BALANCE SHEET
As at date shown
Amounts in EUR '000 31 March 2017 2016
Intangible assets 56,148 56,680
Property, plant and equipment 6,442 6,043
Long-term prepayments 2,495 1,622
Restricted cash 248 248
Total non-current assets 65,333 64,593
Inventories 18,901 17,941
Trade and other receivables 19,846 12,360
Cash and cash equivalents 27,358 31,889
Total current assets 66,105 62,190
Total assets 131,438 126,783
Share capital 4,789 4,556
Share premium 308,320 301,876
Legal reserves 40 60
Accumulated deficit (284,209) (279,025)
Shareholders' equity 28,940 27,467
Loans and borrowings 33,566 40,395
Deferred license fees income 2,068 2,270
Finance lease liabilities 599 599
Other provisions 4,674 4,674
Total non-current liabilities 40,907 47,938
Loans and borrowings 31,229 26,136
Deferred license fees income 877 943
Derivative financial liabilities 12,407 9,982
Trade and other payables 16,882 14,054
Finance lease liabilities 196 263
Total current liabilities 61,591 51,378
Total equity and liabilities 131,438 126.783
Consolidated statement of cash flows
For the first quarter ended 31 March
Amounts in EUR'000 2017 2016
Operating result 3,872 (3,170)
Depreciation, amortization 839 151
Accrued employee benefits 564 457
Deferred license fees (268) (552)
Operating cash flows before changes in working
capital 5,007 (3,114)
Changes in working capital:
Inventories (960) (1,621)
Trade and other receivables (11,221) (657)
Payables and other current liabilities 2,828 2,273
Total changes in working capital
Changes in non-current assets, liabilities and
equity (581) 182
Net cash flows used in operating activities (4,927) (2,937)
Capital expenditure for property, plant and
equipment (654) (240)
Investment intangible assets (180) -
Net cash flows used in investing activities (834) (240)
Redemption and interest on borrowings (2,413) -
Repayment and interest on loans (775) (273)
Proceeds from debt capital 4,444 -
Net cash flows from financing activities 1,256 (273)
Increase (decrease) of cash (4,505) (3,450)
Exchange rate effects (26) (687)
Cash and cash equivalents at 1 January 32,137 31,843
Total cash and cash equivalents at 31 March 27,606 27,706
Pharming Group N.V.
Sijmen de Vries, CEO, Tel: +31-71-524-7400
Robin Wright, CFO, Tel: +31-71-524-7432
Julia Phillips/ Victoria Foster Mitchell, Tel: +44-203-727-1136
Lifespring Life Sciences Communication
Leon Melens, Tel: +31-6-53-81-64-27