4
Vifor Pharma Ltd. Half-year Report 2020 4 LETTER TO SHAREHOLDERS “As a result of the H1 2020 performance, we have updated our full-year guidance, and are confident to grow our EBITDA in the range of 20% in 2020.” STEFAN SCHULZE CHIEF EXECUTIVE OFFICER JACQUES THEURILLAT CHAIRMAN OF THE BOARD OF DIRECTORS

LETTER TO SHAREHOLDERS/media/Files/V/Vifor-Pharma/...LETTER TO SHAREHOLDERS “As a result of the H1 2020 performance, we have updated our full-year guidance, and are confident to

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: LETTER TO SHAREHOLDERS/media/Files/V/Vifor-Pharma/...LETTER TO SHAREHOLDERS “As a result of the H1 2020 performance, we have updated our full-year guidance, and are confident to

Vifor Pharma Ltd. Half-year Report 20204

LETTER TO SHAREHOLDERS

“ As a result of the H1 2020 per formance, we have updated our full-year guidance, and are confident to grow our EBITDA in the range of 20% in 2020.”

STEFAN SCHULZECHIEF EXECUTIVE OFFICER

JACQUES THEURILLATCHAIRMAN OF THE BOARD OF DIRECTORS

Page 2: LETTER TO SHAREHOLDERS/media/Files/V/Vifor-Pharma/...LETTER TO SHAREHOLDERS “As a result of the H1 2020 performance, we have updated our full-year guidance, and are confident to

Vifor Pharma Ltd. Half-year Report 2020 5

DEAR SHAREHOLDERS,

Vifor Pharma Group delivered continued growth in the first half of 2020, despite challenges caused by the COVID-19 pandemic. Targeted measures were implemented across the organisa-tion to ensure business continuity and protect our employees, complementing our comprehen-sive resilience planning. These enabled us to avoid product shortages and to ensure continuity of supply. We are proud of the efforts of our employees and partners, and of the sophisticated network of successful collaborations which have helped minimise the consequences of the pandemic for patients who depend on our products.

Temporary challenges to patient access caused by COVID-19 measures affected product demand and net sales in H1 2020. We anticipate it will continue to have a negative impact in certain regions throughout the rest of the year. A number of initiatives to mitigate the profitability impact have been implemented and we are confident that these measures will help us to emerge from this situation even stronger.

In H1 2020, total net sales increased by 4.3%, at constant exchange rates, to CHF 922.5 million, and reported EBITDA went up by 19.8% to CHF 305.1 million compared to CHF 254.6 million in 2019.

The impact of the COVID-19 pandemic reduced revenues of Ferinject®/Injectafer® and Veltassa® in the first half of the year. However, growth was sustained in the nephrology area which was driven by the dialysis business, underlining the success of our therapeutic diversification in recent years. Vifor Pharma Group has updated its full-year guidance for 2020, with net sales expected to grow in the range of 5% at constant exchange rates, and reported EBITDA expected to grow in the range of 20%.

Patient blood management (PBM), which includes proactive identification and treatment of iron deficiency and anaemia, is a major growth area for Ferinject®/ Injectafer®. The COVID-19 pandemic significantly impacted blood donations around the world, putting patients at risk and demonstrating the importance of PBM in improving quality of treatment and ensuring security of supply for blood products. PBM was endorsed by the WHO in February 2020 as part of its strategic action framework for universal access to safe, effective and quality-assured blood products. Further significant growth opportunities for Ferinject®/Injectafer® in areas with high unmet medical need include chronic heart failure, nephrology and women’s health.

A number of lifecycle management activities continued to progress in H1 2020, to demonstrate Ferinject®’s unique safety and tolerability profile in different patient populations. Top-line results for the AFFIRM-AHF study, further evaluating the benefits of Ferinject® in heart failure, are on track and expected by the end of 2020.

Page 3: LETTER TO SHAREHOLDERS/media/Files/V/Vifor-Pharma/...LETTER TO SHAREHOLDERS “As a result of the H1 2020 performance, we have updated our full-year guidance, and are confident to

Vifor Pharma Ltd. Half-year Report 2020

LETTER TO SHAREHOLDERS

6

Vifor Pharma is committed to expanding the availability of our products worldwide, and in February 2020, we announced a strategic partnership with Fresenius Kabi, one of the top 10 multinational pharmaceutical companies in China. A new joint company will focus on the i.v. iron portfolio and PBM in China, which has the largest iron deficiency anaemia population in the world. Following phase-III trial results, a New Drug Application (NDA) submission for Ferinject® was accepted by China’s National Medical Products Administration in June 2020.

Our joint company with Fresenius Medical Care, Vifor Fresenius Medical Care Renal Pharma (VFMCRP), is the main driver of our growing and diversified nephrology portfolio. During the COVID-19 pandemic, dialysis and other potentially life-saving treatments continued to be adminis-tered to millions of chronic kidney disease (CKD) patients worldwide.

In another milestone for our portfolio, Velphoro® became a global leader by value in the phosphate binder area in H1, with in-market sales up by 53% to CHF 397 million for MAT Q1 2020. Velphoro® was launched in Canada by Otsuka Canada Pharmaceutical Inc., and in South Korea by Fresenius Medical Care in the first half of 2020.

Venofer® maintained its position as a world leading i.v. iron by volume, with almost 29 million patient years of experience by the end of June 2020.

In April 2020, VFMCRP and Cara Therapeutics announced positive results from the KALM-2 global pivotal phase-III trial in haemodialysis patients with moderate-to-severe CKD-associated pruritus, confirming the outcome of the KALM-1 study. Filing of an NDA in the US for CR845 is expected in the second half of the year.

In May 2020, together with our partner Akebia, we announced positive top-line results from the INNO²VATE studies, which evaluated the safety and efficacy of vadadustat versus darbepoetin alfa for the treatment of anaemia due to CKD in adult patients on dialysis. In February, Vifor Pharma acquired a Priority Review Voucher which, subject to agreement with Akebia, is intended to be use for the filing of vadadustat.

In June 2020, Reference Member State Germany announced the completion of the regulatory decentralised assessment procedure for Rayaldee® in our selected EU countries. National marketing authorisations are expected in countries throughout Europe in the second half of 2020.

With our continued focus on execution, we are confident that our new kidney disease therapies CR845, vadadustat, Rayaldee® and avacopan have the potential to generate significant growth, helping to further establish Vifor Pharma Group as a global leader in nephrology.

Veltassa® is our innovation for the long-term management of hyperkalaemia in chronic heart failure and CKD patients. In H1 2020, COVID-19 measures impacted the number of patients visiting nephrologist practices and face-to-face promotion was temporarily suspended, slowing new patient uptake.

We continue to invest in studies demonstrating Veltassa®’s benefits in chronic heart failure to further build market awareness and help patients with hyperkalaemia. The screening and random-isation of new patients into the DIAMOND study, designed to evaluate Veltassa® in combination with RAAS inhibitors, was temporarily discon-tinued in H1 in line with guidance issued by the FDA to minimise patient exposure to COVID-19. We have monitored the situation closely and re-initiated screening and randomisation in certain regions towards the end of June.

Page 4: LETTER TO SHAREHOLDERS/media/Files/V/Vifor-Pharma/...LETTER TO SHAREHOLDERS “As a result of the H1 2020 performance, we have updated our full-year guidance, and are confident to

Vifor Pharma Ltd. Half-year Report 2020 7

Reimbursement approvals for Veltassa® were received in Finland and Portugal during the first half of the year. Our partner Otsuka Canada Pharmaceutical Inc., launched Veltassa® in Canada in May. Full formulary access in England, Wales and Northern Ireland was achieved as a result of the NICE technology appraisal guidance.

In May 2020, Etienne Jornod stepped down after 25 years of highly distinguished service as Executive Chairman. We sincerely thank Etienne for his extensive contribution to Vifor Pharma’s success. His long-standing and successful leadership has been recognised by his appoint-ment as Honorary Chairman.

We are grateful to our shareholders for their confidence and support as we seek to build on Etienne’s legacy, and take up the roles of Chairman of the Board of Directors and CEO. We look forward with optimism to the future, and continue to execute on our strategy to make Vifor Pharma the global leader in iron deficiency, nephrology and cardio-renal therapies, and further develop our plans for sustained mid and long-term profitable growth.

Thank you to our employees for their continued hard work and dedication, and our shareholders for their support during these unprecedented times for our company and our communities. Vifor Pharma remains committed to delivering our company mission, helping patients around the world with severe and chronic diseases lead better, and healthier lives.

Yours sincerely,

Stefan Schulze Jacques Theurillat Chief Executive Officer Chairman of the Board of Directors

“ We are proud of the efforts of our employ-ees and partners, and of the sophisticated network of successful collabor ations which have helped minimise the consequences of the pandemic for patients who depend on our products.”