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HALF-YEAR REPORT 2019 Worldreginfo - F1b4840d-3Aaa-4093-82D3-3B7d6701d3b7 VIFOR PHARMA HALF-YEAR REPORT 2019 WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 1 05.08.2019 13:10:48 PATIENTS AT OUR CORE About Andy Andy is a chef based in London with his wife Sarah and son Noah. He has lived with iron deficiency since being diagnosed at the age of 16. Despite living with iron deficiency and Crohn’s disease, he leads an active life and has a passion for food. He successfully competes at international cooking competitions. Andy recognises the signs and symptoms of iron deficiency and is able to proactively manage his iron levels with his physician, and the support of his wife. Today, Andy enjoys life without restrictions. WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 2 05.08.2019 13:10:51 TABLE OF CONTENTS 04 Letter to shareholders 27 2019 Outlook and financial guidance 06 Highlights 09 Vision, mission and strategy 28 Consolidated interim financial statements 10 Performance overview 30 Consolidated statement of income 31 Consolidated statement of 12 Our products comprehensive income Key growth drivers 32 Consolidated statement of financial position 14 Ferinject®/Injectafer® 33 Consolidated statement of changes in equity 18 Vifor Fresenius Medical Care Renal Pharma 34 Consolidated statement of cash flows 18 RENAL ANAEMIA MANAGEMENT 35 Notes to the consolidated financial statements 18 – Erythropoiesis-Stimulating Agents (ESAs) 18 – Mircera® 42 Upcoming dates 18 – Retacrit™ 43 Contact information 18 – Venofer® 19 – Vadadustat 19 MINERAL AND BONE MANAGEMENT 19 – Velphoro® 19 – Rayaldee® 20 KIDNEY FUNCTION PRESERVATION 20 – Avacopan 20 – CCX140 20 CONDITIONS ASSOCIATED WITH KIDNEY IMPAIRMENT AND ITS TREATMENT 20 – CR845 22 Veltassa® 24 Other products 24 – Maltofer® 24 – VIT-2763 25 OM PHARMA 25 – Broncho-Vaxom® 25 – Uro-Vaxom® 25 – Doxium® Vifor Pharma Ltd. Half-year Report 2019 3 WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 3 05.08.2019 13:10:51 LETTER TO SHAREHOLDERS Etienne Jornod Stefan Schulze DEAR SHAREHOLDER, Vifor Pharma Group achieved a strong financial 25% and 30%. The progress achieved in the first and operating performance in the first half of half of 2019 also makes us confident to achieve 2019, building on the outstanding progress made our Milestone 2020 targets of more than CHF 2 in 2018. Through sustained focus on the execu- billion net sales and EBITDA in the range of tion of our three strategic growth drivers, we are CHF 700 million. on track to deliver our ambitious financial and business goals, and to realise our vision of Each of our three growth drivers, Ferinject®/ becoming global leader in iron deficiency, Injectafer®, the joint company Vifor Fresenius nephrology and cardio-renal therapies. Medical Care Renal Pharma, and Veltassa® delivered a strong performance in H1 2019. It is now more than two years since we created Vifor Pharma as a stand-alone company. We are very happy to report that the positive momen- FERINJECT®/INJECTAFER® tum continued into 2019 and we are well posi- tioned to achieve our objectives for both the full Ferinject®/Injectafer® expanded its position as year 2019 and Milestone 2020. Furthermore the global leader in intravenous (i.v.) iron in value, we are increasingly focused on the goals of with strong growth particularly in the areas of Objective 2025. gastroenterology in the US, and in chronic heart failure and patient blood management in Europe. During the first half of 2019, Vifor Pharma Group By June 2019, the product was approved in 81 further expanded its global leadership position countries, with more than 10 million years of in iron deficiency and continued to move patient experience. We continue to expect full towards leadership in nephrology and cardio- year reported growth of approximately 20% and renal therapies. Total net sales increased by in-market sales for Ferinject®/Injectafer® of 22.2% to CHF 913.3 million, compared to prior more than CHF 1 billion for the full year 2019. year, and reported EBITDA was up 32.6% at CHF 254.6 million compared to CHF 192.0 million in H1 2018. VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA (VFMCRP) We have raised our full year guidance for 2019 with net sales expected to exceed 15% and The partnership with Fresenius Medical Care reported EBITDA expected to grow between through the joint company VFMCRP is the basis 4 Vifor Pharma Ltd. Half-year Report 2019 WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 4 05.08.2019 13:10:57 of our ambition to become the global leader imbursement negotiations and launches will in nephrology. The VFMCRP portfolio continued continue in line with individual reimbursement to grow in the first six months of 2019, due in timelines across Europe throughout 2019 and particular to the recent outstanding success of 2020. Veltassa® is on track to achieve growth in Velphoro® in the US. 2019 of approximately 50%. Mircera® also continued to perform strongly, We are investing in studies that demonstrate exceeding all expectations, primarily due to Veltassa®’s benefits to both patients and clini- the conversion of existing long-acting erythro- cians. Positive results from the phase-II AMBER poiesis-stimulating agent (ESA) patients within study were announced in May 2019, demonstrat- mid-sized and independent dialysis organisations ing Veltassa®’s potential to help patients with in the US. resistant hypertension and CKD to maintain optimal treatment. The DIAMOND study, evaluat- Venofer® maintained its position as the world’s ing the potential of Veltassa® in combination with leading i.v. iron brand in volume terms, with more renin-angiotensin-aldosterone system inhibitors than 25 million patient years of experience. (RAASi) medications to improve patient out- The publication of the PIVOTAL study results in comes, enrolled its first patient in May 2019. Q4 2018 helped to confirm the tolerability of Venofer® as a key differentiator, one of the main reasons the brand retains strong demand after FERROPORTIN many decades on the market. Vifor Pharma also made important progress with In April, we further expanded our partnership its own in-house developed product. In January, with Akebia in the US for vadadustat, creating we reported positive phase-I results from VIT-2763, an opportunity for it to be provided to up to 60% an oral ferroportin inhibitor, which aims to of US dialysis patients, subject to FDA approval. treat diseases related to iron overload. This has provided a strong basis for a phase-II study Velphoro® grew significantly in the US in the first planned to begin in the second half of 2019. half of 2019. This growth was driven by the update of the KDIGO (Kidney Disease Improving Global Outcomes) guidelines in 2017, to recommend the ORGANISATION use of non-calcium-based phosphate binders. The Board of Directors was further strengthened In May, our partner Cara Therapeutics, Inc. in May by the election of Dr Sue Mahony and announced positive results from the first US Kim Stratton to the Board of Directors. We would phase-III trial of CR845 in haemodialysis patients like to express our gratitude to Daniela Boss- with moderate-to-severe pruritus associated with hardt-Hengartner, Dr Sylvie Grégoire and Fritz chronic kidney disease (CKD). The results showed Hirsbrunner who stepped down after many statistically significant improvements in both the years of distinguished service. primary and secondary endpoints, with top-line results from a second global phase-III trial Our success in the first half of 2019 was made expected in H2 2019. possible due to the support of our shareholders and dedicated, talented employees across Vifor Pharma Group, who continue to deliver our VELTASSA® company mission – helping patients around the world with severe and chronic diseases, lead Veltassa®, our third strategic growth driver, better, healthier lives. continued to transform the treatment of patients with hyperkalaemia in the first half of the year. By Yours sincerely, the end of June, Veltassa® had been prescribed to over 100,000 patients since launch in the US, and is among the fastest growing nephrology drugs in the last ten years. In May 2019, the Act on the Reform of the Market Etienne Jornod Stefan Schulze for Medicinal Products (AMNOG) process Executive Chairman of President of the for Veltassa® in Germany was completed, with the Board of Directors Executive Committee Veltassa® now fully reimbursed. Further re- and COO Vifor Pharma Ltd. Half-year Report 2019 5 WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 5 05.08.2019 13:10:57 HIGHLIGHTS NET SALES MILLION CHF 913.3+22.2% EBITDA MILLION CHF 254.6+32.6% CORE EARNINGS¹ CASH FLOW FROM PER SHARE OPERATING ACTIVITIES EQUITY RATIO 2.11 CHF 197.9 MILLION CHF 74.0% –20.7% +159.6 million CHF –0.8 p.p. 1 Core earnings are defined as reported earnings after minorities adjusted for proportionate amortisation of intangible assets. 6 Vifor Pharma Ltd. Half-year Report 2019 WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 6 05.08.2019 13:10:57 TOTAL FERINJECT®/ INJECTAFER® NET SALES MILLION CHF 273.4+19.4% MIRCERA® NET SALES MILLION CHF 276.2+29.0% VELTASSA® NET SALES MILLION CHF 62.6+69.9% Vifor Pharma Ltd. Half-year Report 2019 7 WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 7 05.08.2019 13:10:57 8 Vifor Pharma Ltd. Half-year Report 2019 WorldReginfo - f1b4840d-3aaa-4093-82d3-3b7d6701d3b7 Half Year Report 2019_English_1 8 05.08.2019 13:10:58 VISION, MISSION AND STRATEGY Our vision To be global leader in iron deficiency, nephrology and cardio-renal therapies. The partner of choice for specialty pharmaceuticals and innovative, patient-focused solutions. Our mission We strive to help patients around the world with severe and chronic diseases lead better, healthier lives.
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  • How to Take Your Phosphate Binders
    How to take your phosphate binders Information for renal patients Oxford Kidney Unit Page 2 What are phosphate binders? To reduce the amount of phosphate you absorb from your food you may have been prescribed a medicine called a phosphate binder. Phosphate binders work by binding (attaching) to some of the phosphate in food. This will reduce the amount of phosphate being absorbed into your blood stream. A list of phosphate binders and how to take them is shown below. Phosphate binder How to take it Calcichew (calcium carbonate) Chew thoroughly 10-15 minutes before or immediately before food Renacet (calcium acetate) Phosex (calcium acetate) Osvaren (calcium acetate and magnesium carbonate) Swallow whole after the first Renagel 2-3 mouthfuls of food (sevelemer hydrochloride) Renvela tablets (sevelemer carbonate) Alucaps (aluminium hydroxide) Renvela powder Dissolve in 60ml of water and (sevelemer carbonate) take after the first 2-3 mouthfuls of food Fosrenol tablets Chew thoroughly towards the (lanthanum carbonate) end/immediately after each meal Fosrenol powder Mix with a small amount of (lanthanum carbonate) food and eat immediately Velphoro Chew thoroughly after the first (sucroferric oxyhydroxide) 2-3 mouthfuls The phosphate binder you have been prescribed is: ……………………………………………………………………………………………………………………………………………………….. Page 3 How many phosphate binders should I take? You should follow the dose that has been prescribed for you. Your renal dietitian can advise how best to match your phosphate binders to your meal pattern, as well as which snacks require a phosphate binder. What happens if I forget to take my phosphate binder? For best results, phosphate binders should be taken as instructed.
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