Full year revenues from product sales were up over 51% on 2017 to €134.3 million, reflecting strong growth in both the USA and Europe. Including deferred license income, total revenues were €135.1 million – an increase of almost 51% on 2017
Fourth quarter product sales of €36.7m (US$41.9 million) – as guided; in similar range to Q3 2018
2018 US product sales triggered first $20 million milestone payment to Valeant, paid earlier this month
Full year net profits, including financing costs and non-cash adjustments, were €25.0 million
Full year unadjusted operating profit (EBIT) of €40.6 million (US$48.0 million), before a non-cash adjustment to take previously capitalised development costs for a superseded new form of RUCONEST® through the income statement,, resulting in a final figure of €38.0 million (US$44.9 million)
Cash ended at €81.5 million, an increase of €21.5 million versus year end 2017
Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) presents its preliminary (unaudited) financial report for the full year ended 31 December 2018. The Company will hold a conference call at 13.00 CET/07.00 EST today. Dial in details can be found on page 11 of this report.
“Throughout 2018, as for 2017, we continue to see consistent growth in the numbers of patients benefitting from RUCONEST® in acute attacks of hereditary angioedema (“HAE”). The initial significant surge in growth was caused by patients starting RUCONEST® therapy after we had provided unrestricted emergency treatments free of charge, to cope with the supply shortages of competitor plasma C1 inhibitor products. We retained many of these patients and added new patients throughout the year. The increasing sales from our growing patient base resulted in Pharming’s first year of net profit, despite intense competitive pressure resulting from recent product launches. It also enabled us to increase investment to expand our pipeline, embarking on ambitious development plans for improved delivery methods for RUCONEST® in HAE and for new larger indications. We also continued to advance our existing pipeline programs for Pompe disease and Fabry’s disease. We are confident that with our increasing patient reach and advancing pipeline, we will to continue to deliver significant value to all our stakeholders.”
2018 was an exciting year for Pharming. We built on the strong foundations of the successful re-launch of RUCONEST® in the USA in 2017, continuing impressive product sales growth from €88.7 million in 2017 to €134.3 million in 2018, an increase of 51%. As well as strong growth in the USA, we continued to develop RUCONEST® in all key markets. In Europe, direct sales grew well during the year, particularly in the major markets of Western Europe, resulting in strong gains in France and the UK and continued growth in Germany, Austria and the Netherlands.
As result of the steady sales growth, the Company was profitable at the net level in every quarter and for the year as a whole. Total net profit for the year ended at €25.0 million, representing a net margin of 19% and well ahead of analysts’ forecasts. Operating profit for the year (i.e. EBIT), before a one-off small non-cash correction, almost doubled to €40.6 million (2017: €21.9 million on the same basis), representing an improved operating margin of 30% (2017: 24%). This was achieved despite significant investments in providing free-of-charge emergency support to patients during the stock outages of competitors at the start of the year.
As a result of the continued sales growth in the USA, we achieved the sales level required to trigger the first US$20 million milestone payment due to Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals International, Inc.) which was duly made earlier this week. If sales growth continues at or near the current level, the remaining US$45 million milestones will also be triggered in this or future years.
As a result, we have prudently made a (non-cash) provision for additional fair value of the contingent consideration in the balance sheet, and a corresponding charge to the profit and loss account, of €21.2 million ($25.0 million).
In addition, the increasing profitability of Pharming means that we are likely to be able to use all of our accumulated net operating tax losses, and so we have increased the deferred tax asset which recognises these by a net amount of €25.6 million (2017: €9.4 million), being mainly the tax effect of the total accumulated losses to date in the Netherlands. These two provisions reflect our strong confidence in the performance of our US and EU commercial teams and patients’ increasing confidence in the use of RUCONEST® as their therapy of choice to treat attacks of HAE.
The HAE market remains dynamic, and patient choice continues to increase as new products enter the market for prophylaxis. RUCONEST® has a unique potential competitive advantage in that it is currently the only product with the future potential to be approved for both prophylaxis and treatment of attacks of HAE. Furthermore, in order to increase the convenience of RUCONEST® for patients, we are developing new forms of RUCONEST® with new routes of administration to address both acute attacks and prophylaxis of HAE, such as (painless) intradermal, sub-cutaneous and intramuscular dosage forms with a new ready-mixed liquid vial.
At the end of 2017, we explained our strategy for sales growth in HAE based on creating an optimized sales infrastructure for our needs. During 2018 we have been able to develop this strategy further to add programs for new routes of administration for RUCONEST® and preparation for expansion of rhC1INH into other larger indications, specifically pre-eclampsia and acute kidney injury. We also continued preparation of a clinical trial program for α-glucosidase for Pompe disease. This enhanced strategy and developing pipeline provides Pharming with excellent potential to deliver strong sustainable growth for the long term in these very large areas of unmet medical needs.
None of these achievements and development programs would be possible without the support, expertise and hard work of all our employees. I would like to take this opportunity once again to thank all Pharming employees as well as all of our investors, partners and debt providers for their support and commitment throughout 2018, which enabled us to execute on the commercial development of the Company to create a platform for continued growth.
I look forward with confidence to continuing the upward trajectory of Pharming in 2019, with sales increasing further, new exciting pipeline projects and new opportunities for enhanced shareholder value.
Leiden, 7 March 2019
Sijmen de Vries
Chief Executive Officer and Chairman of the Board of Management
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 Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Megapharm.
RUCONEST® has recently completed a clinical trial for the treatment of HAE in young children (2-13 years of age) and is also 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.
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
Tel: +31 6 53 81 64 27
The full press release is available for download on the Pharming website.
全年未经调整的营业利润（ EBIT ）为4060万欧元（4800万美元），在进行非现金调整之前，通过损益表将先前已资本化的开发成本转换为新形式的 RUCONEST ®之前，得出最终数字为3800万欧元（4490万美元）
Pharming Group N.V .（“ Pharming ”或“本公司”）（ Euronext Amsterdam ： PHARM ）提交其截至2018年12月31日止年度的初步（未经审计）财务报告。本公司将于今日（东部时间）下午13:00召开电话会议。详情可在本报告第11页找到。
“整个2018年，就2017年而言，我们继续看到受益于 RUCONEST ®的患者数量在遗传性血管水肿（“ HAE ”）的急性发作中持续增长。在我们免费提供不受限制的紧急治疗后，为了应对竞争对手血浆 C1抑制剂产品的供应短缺，患者开始使用 RUCONEST ®疗法，导致了最初的显著增长。我们保留了许多这些病人，并在一年中增加了新的病人。尽管近期产品上市带来了激烈的竞争压力，但由于我们不断增长的客户群的销售增加， Pharming 实现了第一年的净利润。它还使我们能够增加投资，以扩大我们的管道，开始雄心勃勃的发展计划，改进在 HAE 的 RUCONEST ®的交付方法和新的更大的适应症。我们还继续推进现有的蓬佩病和法布里病管道项目。我们相信，随着我们的病人人数不断增加和管道的推进，我们将继续为我们的所有利益相关者带来重大价值。”
2018年对法明来说是激动人心的一年。我们在成功于2017年在美国重新推出 RUCONEST ®的坚实基础上，继续保持了令人印象深刻的产品销售增长，从2017年的8870万欧元增至2018年的1.343亿欧元，增长了51%。随着美国市场的强劲增长，我们继续在所有主要市场开发 RUCONEST ®产品。在欧洲，本年度直接销售增长良好，尤其是在西欧主要市场，导致法国和英国强劲增长，德国、奥地利和荷兰继续增长。
由于销售稳步增长，本公司于各季度及全年均实现净利润水平。该年度的净利润总额为2,500万欧元，净利润率为19%，远高于分析师的预期。在一次性小额非现金修正之前，本年度的营业利润（如 EBIT ）几乎翻了一番，达到4060万欧元（2017年：2190万欧元，按相同基准计算），提高了30%（2017年：24%）。尽管在年初竞争对手的库存中断期间对向患者提供免费紧急支持进行了大量投资，但还是实现了这一目标。
由于美国销售持续增长，我们实现了首笔2000万美元里程碑付款所需的销售水平，这是由于本周早些时候正式支付的 Bausch Health Companies Inc .（前威朗（Valeant） Pharmaceuticals International , Inc .）。如果销售增长保持在或接近当前水平，剩余的4500万美元里程碑也将在今年或未来几年触发。
此外， Pharming 盈利能力的不断增强意味着我们可能能够使用我们所有的累计净营业税收损失，因此我们增加了确认这些损失的净额2560万欧元（2017年：940万欧元）的递延税项资产。主要是荷兰迄今累计损失总额的税务影响。这两项条款反映了我们对美国和欧盟商业团队的表现的强烈信心，以及患者对使用 RUCONEST ®作为治疗港机工程攻击首选疗法的信心日益增强。
港机工程市场仍然充满活力，随着新产品进入预防市场，病人的选择继续增加。RUCONEST ®具有独特的潜在竞争优势，因为它是目前唯一具有未来潜力的产品，可用于预防和治疗港机工程的攻击。此外，为了提高 RUCONEST ®对患者的便利性，我们正在开发新形式的 RUCONEST ®，采用新的给药途径，以解决急性发作和预防性的 HAE ，如（无痛的）皮肤内、皮下和肌内剂型，配有新的混合液体小瓶。
于二零一七年年底，我们根据为我们的需要建立优化的销售基础设施，解释我们在港机工程的销售增长策略。2018年，我们能够进一步制定这一战略，为 RUCONEST ®的新给药途径增加计划，并为 rhC1INH 扩展到其他更大的适应症（特别是子痫前期和急性肾损伤）做好准备。我们还继续为庞贝病的α-葡萄糖苷酶临床试验计划的准备。这一加强的战略和发展的管道为 Pharming 提供了极好的潜力，在这些未得到满足的医疗需求非常大的领域实现长期的强劲可持续增长。
如果没有我们所有员工的支持、专业知识和辛勤工作，这些成就和发展计划都不可能实现。我谨借此机会再次感谢 Pharming 全体员工以及我们的所有投资者、合作伙伴和债务提供商在2018年全年的支持和承诺，使我们能够在公司的商业发展上执行，为持续增长创造平台。
我充满信心地期待着 Pharming 在2019年继续上行，随着销售进一步增长，新的令人兴奋的管道项目和新的机会，提高股东价值。
Sijmen de Vries
药明医药是一家专业医药公司，为罕见病的安全、有效治疗和未满足的医疗需求开发创新产品。Pharming 的主导产品 RUCONEST ®（ conestat alfa ）是一种重组人 C1酯酶抑制剂，用于治疗欧洲、美国、以色列和韩国的急性遗传性血管水肿（ HAE ）发作。该产品在其他尚未获得营销授权的地区以指定患者为基础提供。
RUCONEST ®由 Pharming 在阿尔及利亚、安道尔、奥地利、巴林、比利时、法国、德国、爱尔兰、约旦、科威特、黎巴嫩、卢森堡、摩洛哥、荷兰、阿曼、葡萄牙、卡塔尔、叙利亚、西班牙、瑞士、突尼斯、阿拉伯联合酋长国、联合王国、美利坚合众国和也门进行商业化。
RUCONEST ®由瑞典孤儿 Biovitrum AB （ pull ）（ SS ： SOBI ）在其他欧盟国家和阿塞拜疆、白俄罗斯、佐治亚、冰岛、哈萨克斯坦、列支敦士登、挪威、俄罗斯、塞尔维亚和乌克兰发行。
RUCONEST ®由 Cytobieck 在哥伦比亚、哥斯达黎加、多米尼加共和国、巴拿马和委内瑞拉发行，在韩国由 HyupJin 公司发行，在以色列由 Megaphaarm 发行。
RUCONEST ®最近完成了一项治疗年轻儿童（2-13岁）的 HAE 的临床试验，并对各种附加的后续适应症进行了评估。
Pharming 的技术平台包括一种独特的、符合 GMP 要求的、经过验证的纯重组人蛋白生产工艺，与目前基于细胞系的方法相比，该工艺已证明能够以更经济、更少免疫遗传学的方式生产出大量高质量的重组人蛋白。目前正在优化用于 Pomp é和 Fabry's 疾病的酶替代治疗（“ ERT ”）的方法，目前还在探索不涉及 ERT 的其他方案。
Pharming 与国药（Sinopharm）一致下属的中国医药工业国家研究所（“ CSPI ”）建立长期合作关系，共同开发新产品。从治疗血友病 A 的重组人凝血因子 VIII 开始。临床前的开发和制造将按照 CSPI 的全球标准进行，并由 CSPI 提供资金。临床开发将由合作伙伴与每个合作伙伴共同承担各自区域在合作伙伴关系下的费用。
更多信息请访问 Pharming 网站:\160; www.pharming.com
本 Pharming Group N.V .及其子公司（“ Pharming ”、“本公司”或“本集团”）的新闻稿可能包含前瞻性陈述，包括但不限于有关 Pharming 的财务预测、市场预期、发展、合作伙伴关系、计划、战略和资本支出的声明。
Sijmen de Vries ，首席执行官
首席财务官 Robin Wright
Julia Phillips / Victoria Foster Mitchell