Quarterly Report • May 17, 2018
Quarterly Report
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Leiden, The Netherlands, 17 May 2018: Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) presents its (unaudited) financial report for the quarter ended 31 March 2018.
provide additional capacity to cover further potential stock shortages by competitors. This resulted in a greater proportion of inventories being held in final dosage forms of product rather than raw materials which are recognized at a lower carrying value per unit.
"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."
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.
3 months to 31 March
| 2018 | 2017 | % | |
|---|---|---|---|
| Amounts in €m except per share data | Change | ||
| Income Statement | |||
| Revenue from product sales | 29.3 | 15.2 | 93% |
| Other revenue | 0.2 | 0.3 | (33%) |
| Total revenue | 29.5 | 15.5 | 90% |
| Gross profit | 24.5 | 13.8 | 78% |
| Operating result | 8.2 | 3.9 | 110% |
| Net result | 3.3 | (5.7) | 158% |
| Balance Sheet | |||
| Cash & marketable securities | 59.8 | 27.6 | 117% |
| Share Information | |||
| Earnings per share before dilution (€) | 0.006 | (0.012) | 150% |
For the remainder of 2018, the Company expects:
Continued investment in the production of RUCONEST® in order to ensure continuity of supply to the growing markets in the US, Europe and the rest of the world.
Investment in RUCONEST® in prophylaxis of HAE (following approval) and in the development of new intramuscular and subcutaneous versions of RUCONEST®.
No further financial guidance for 2018 is provided.
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: 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
For the period, in Euros:
| Amounts in € '000 | Q1 | Q1 |
|---|---|---|
| 2018 | 2017 | |
| 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 (€) | 0.006 | (0.012) |
For the period, in Euros
| Amounts in € '000 | Q1 | Q1 |
|---|---|---|
| 2018 | 2017 | |
| 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: | ||
| Owners of the parent | 1,904 | (5,768) |
As at date shown, in Euros
| Amounts in € '000 | 31 March | 31 December |
|---|---|---|
| 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 |
For the period, in Euros
| Amounts in €'000 | Q1 | Q1 |
|---|---|---|
| 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 |
For the period, in US dollars
| Amounts in \$ '000 | Q1 | Q1 |
|---|---|---|
| 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.
As at date shown, in US dollars
| Amounts in \$ '000 | 31 March | 31 December |
|---|---|---|
| 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.
For the period, in US dollars
| Amounts in \$'000 | Q1 | Q1 |
|---|---|---|
| 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.
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