Quarterly Report • May 17, 2017
Quarterly Report
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Operating profitability achieved, with a 794% increase in revenues from product sales, demonstrating the benefits of reacquiring RUCONEST® commercialisation rights in the US
Leiden, The Netherlands, 17 May 2017: Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) presents its (unaudited) financial report for the quarter ended 31 March 2017.
from €45.0 million to €36.6 million. No cash payment was required for the first installment of the Bonds due on 1 February 2017, only €125,000 was required for the second installment, paid on 1 March 2017, and €1.3 million was required for the third installment, paid on 31 March 2017.
The Company's cash position decreased from €32.1 million at year-end 2016 to €27.6 million at 31 March 2017 (€27.5 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.
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® 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® sales in the US market, as well as in Europe and other markets where Pharming sells RUCONEST® directly.
In February, the European Medicines Agency (EMA) confirmed that the RUCONEST® label would be amended, allowing for home treatment by patients themselves, with a custom-designed selfadministration 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® administration, our R&D scientists have formulated a highly-concentrated vial of RUCONEST® with the intention of entering clinical trials with intra-muscular and/or sub-cutaneous administration of smaller injections of RUCONEST® 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® 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® 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 €m except per share data | Change | ||
| Income Statement | |||
| 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%) |
| Balance Sheet | |||
| Cash & marketable securities | 27.6 | 27.7 | (0%) |
| Share Information | |||
| Earnings per share before dilution (€) | (0.012) | (0.008) | (50)% |
For the remainder of 2017, the Company expects:
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.
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 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® 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 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: 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.
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
Leon Melens, Tel: +31 6 53 81 64 27
| Amounts in €'000, except per share data | Q1 | Q1 |
|---|---|---|
| 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) |
| Attributable to: | ||
| Owners of the parent | (5,748) | (3,385) |
| Total net result | (5,748) | (3,385) |
| Basic earnings per share (€) from continuing operations | (0.012) | (0.008) |
| Amounts in € '000 | 31 March 2017 | 31 December |
|---|---|---|
| Non-current assets | 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 |
| Current assets | ||
| 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 |
| Equity | ||
| 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 |
| Non-current liabilities | ||
| 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 |
| Current liabilities | ||
| 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 |
For the first quarter ended 31 March
| Amounts in €'000 | 2017 | 2016 |
|---|---|---|
| Operating result | 3,872 | (3,170) |
| Non-cash adjustments: | ||
| 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 | (9,353) | (5) |
| 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 |
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