annual report 2020 at a glance - vifor pharma

VIFORPHARMA

ANNUAL REPORT 2020AT A GLANCE

T A B L E O F C O N T E N T S

Vifor Pharma Ltd. Annual Report 20202

4 Letter to Shareholders6 Financial highlights 8 Company highlights10 Our company18 Performance overview

50 Members of the Executive Committee 52 Members of the Board of Directors54 Group structure and shareholders56 Structure of the share capital

C O N S O L I D A T E D F I N A N C I A L S T A T E M E N T S

46 Consolidated statement of income47 Consolidated statement of financial position48 Consolidated statement of cash flows49 2021 Outlook and financial guidance

G O V E R N A N C E

P O R T F O L I O

H I G H L I G H T S

F I N A N C E

5 8 U P C O M I N G D A T E S

5 9 C O N T A C T I N F O R M A T I O N

I R O N D E F I C I E N C Y

20 Ferinject®/Injectafer®29 Maltofer®N E P H R O L O G Y

31 Mircera®31 Retacrit®31 Venofer® 32 Vadadustat 34 Velphoro®35 Rayaldee® 36 Avacopan38 ANG-377738 DifelikefalinC A R D I O - R E N A L

40 Veltassa® O T H E R I R O N T H E R A P I E S

44 VIT-2763

Vifor Pharma Ltd. Annual Report 2020 3

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S T E F A N S C H U L Z E

CHIEF EXECUTIVE OFFICER

J A C Q U E S T H E U R I L L A T

CHAIRMAN OF THE BOARD

OF DIRECTORS

L E T T E R T O S H A R E H O L D E R SH I G H L I G H T S

Two words encapsulate the performance of Vifor Pharma Group in 2020: continuity and adaptability.“

“

D E A R S H A R E H O L D E R S ,

Despite the extraordinary challenges of COVID-19, our employees and partners ensured Vifor Pharma’s therapies continued to reach the patients who depend on them without disruption. We are proud of these efforts and would like to thank our employees for their ongoing dedication to helping patients, caregivers and communities around the world during the pandemic.

In challenging market conditions, we contin-ued to grow our leadership position in iron deficiency and nephrology. Our strategy to expand our nephrology portfolio in recent years has been very successful. The planned read-outs of our own clinical trials and those of our partners occurred despite COVID-19 restrictions. We progressed with launch preparations for our pipeline of innovative new therapies, formed exciting new partner-ships, and expanded our global presence.

The Ferinject®/ Injectafer® business was significantly impacted by the pandemic, with i.v. iron utilization highly correlated with the intensity of lockdown measures during the course of the year. Infusion centers were temporarily closed, elective surgeries can-celled, and high risk patient populations postponed visits to physicians and administra-tion sites for infusions. Direct contact with healthcare providers to discuss the benefits of products such as Veltassa® was not possible. Clinical trials were re-evaluated and patient recruitment and office visits were adjusted in line with regulatory guidance, as we sought to protect patients and caregivers involved.


Despite this backdrop, and the related impact of a much stronger Swiss franc against the US Dollar, Vifor Pharma Group reported contin-ued strong profit growth. EBITDA was almost 19% higher at CHF 575.8 million, helped by disciplined cost control. Excluding the 2019 one-off IAS19 income, the rise in EBITDA was 36% at constant exchange rates. Revenues were up 3.7% at constant exchange rates compared to prior year but down 1% on a reported basis to CHF 1,705.6 million.

Sales of our blockbuster i.v. iron product Ferinject®/ Injectafer® returned quickly to projected growth levels in the summer after declines in Q2, as COVID-19 restrictions eased in many markets. With a second wave of COVID-19 again slowing sales towards year-end, the strong recovery demonstrated in Q3 provides high confidence that growth will return to expected levels as soon as restrictions ease. Venofer® benefited from strong US growth, particularly in the hospital sector, and Velphoro® became a global leader in the calcium-free phosphate binder market. Ferinject® was launched in Japan and re-ceived regulatory submission acceptance in China.

Although the market hasn’t grown in line with our expectations, Veltassa® continued to be a global leader in the hyperkalemia market. It was launched in Canada and received favour-able reimbursement decisions in many European countries, as well as support for an important label change, confirming its ability to enable RAAS (renin-angiotensin-al-dosterone system) inhibitor treatment in a key cohort of patients.

Major progress was made in building Vifor Pharma’s leadership in our strategic core areas of expertise, reinforced by the success-ful divestment of OM Pharma.

Following positive phase-III results, we expanded our license for difelikefalin (KORSUVATM) in the US and our partner Cara Therapeutics filed for US approval. A new

collaboration was established in China with Fresenius Kabi AG for Ferinject® as well as Veltassa®. Avacopan, a promising new therapy for rare kidney diseases, was submitted for approval in Europe.

By acquiring rights to ANG-3777, we are expanding our leading nephrology presence into transplantation and acute kidney injury. Positive trial results for vadadustat for anemia in CKD patients on dialysis, and progress in the phase-II trial of VIT-2763 in beta-thalas-semia added to confidence in our pipeline.

Our strong momentum will continue in 2021. Potential approvals include Ferinject® in China, difelikefalin (KORSUVATM) in the US and avacopan in Europe, with respective market launches in preparation. We’re looking forward to readouts from the key trials of ANG-3777.

We want to thank everyone at Vifor Pharma and our partners for facing the unprecedent-ed challenges of 2020 with flexibility and imagination, and to thank all our shareholders for their continued support and confidence.

With a portfolio of innovative nephrology treatments on track to be launched from the end of 2021 onwards, the continuing expan-sion of our global presence, and a reputation as a go-to industry partner for in- and out- licensing, we can look to the future with great confidence and optimism.

Yours sincerely,

Stefan Schulze Chief Executive Officer

Jacques Theurillat Chairman of the Board of Directors


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1,705.6NET SALES

EBITDA

575.8

4.99CHF

CORE EARNINGS¹ PER SHARE FROM CONTINUING OPERATIONS

+28.7%

Core earnings are defined as reported earnings after minorities adjusted for proportionate amortization and impairment of intangible assets.

1

423.8MILLION CHF

CASH FLOW FROM OPERATING ACTIVITIES

–101.0 MILLION CHF

77.1%

EQUITY RATIO

+1.4 P.P.

–1.1% (+3.7% AT CONSTANT EXCHANGE RATES)

+18.7% (+29.4% AT CONSTANT EXCHANGE RATES)

MILLION CHF

MILLION CHF

F I N A N C I A L H I G H L I G H T S 2 0 2 0


MIRCERA®/ RETACRIT® NET SALES

VENOFER® NET SALES

524.3

136.2

552.2TOTAL FERINJECT®/ INJECTAFER® NET SALES



+2.9% (+8.4% AT CONSTANT EXCHANGE RATES)

MILLION CHF

MILLION CHF

MILLION CHF


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C O M P A N Y H I G H L I G H T S 2 0 2 0

2020 has been a successful year. Through new partnerships, global expansion and innovative treatment therapies, we have continued to help patients worldwide.

Successful sale of OM Pharma

S E P T E M B E R

Gregory Oakes appointed as President North America

S E P T E M B E R

Vifor Pharma and Cara Therapeutics sign license agreement for i.v. difelikefalin in US

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VFMCRP & ChemoCentryx announce EMA accepts to review MAA for avacopan

N O V E M B E R

Vifor Pharma and Fresenius Kabi form joint venture in China

F E B R U A R Y

Lee Heeson appointed as President International

F E B R U A R Y

Vifor Pharma Group reports continued growth in H1 2020

A U G U S T

Dr Klaus Henning Jensen appointed as Chief Medical Officer

J A N U A R Y

20

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VFMCRP and Cara Therapeutics announce positive results from global KALM-2 pivotal phase-III trial of difelikefalin injection

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Vifor Pharma and Angion sign license agreement for ANG-3777 in DGF and CSA-AKI

N O V E M B E R

VFMCRP and Fresenius Kabi expand collaboration in nephrology in China with Veltassa® agreement

N O V E M B E R

Full results from AFFIRM-AHF study presented at AHA

N O V E M B E R

Iron Deficiency Day 2020 highlights global impact on health and gender inequality

N O V E M B E R

Stefan Schulze appointed Chief Executive Officer

92nd Annual General Meeting Jacques Theurillat elected as the new Chairman of the Board of Directors

Etienne Jornod appointed Honorary Chairman

Vifor Pharma announce Akebia’s positive top-line results from INNO2VATE studies, a global phase-III program of vadadustat

M A Y

M A Y

M A Y

20

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Topline results from the ACCOLADE trial for avacopan

D E C E M B E R


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O U R C O M P A N YH I G H L I G H T S

O U R C O M P A N Y

At Vifor Pharma, patients are at the center of everything we do, and we go where only few go to find the right treatment solutions for them. Over the last three decades, we have proven our ability to identify and serve key therapeutic areas with significant unmet medical need, successfully building on our experience and track record to create new markets.

We are the third largest Swiss pharmaceutical company and a global leader in the treatment of iron deficiency. We have established a leading position in the nephrology market

and aim for global leadership in the segment of cardio-renal therapies. Our continued success is underpinned by a strong, diversi-fied portfolio of commercial products and an exciting pipeline.

We are proud to be a partner of choice for pharmaceuticals and innovative patient- focused solutions worldwide. By leveraging our unique competitive strengths to in-license promising new products and compounds, we continue to build strong partnerships and alliances to drive our vision forward.

We strive to help patients around the world with severe and chronic diseases lead better, healthier lives.

O U R M I S S I O N

O U R V I S I O N

To be global leader in iron deficiency, nephrology and cardio-renal therapies.


Sarah is an ANCA-vasculitis and chronic kidney disease patient

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O U R C O M P A N YH I G H L I G H T S

O U R S T R A T E G Y

Vifor Pharma is dedicated to identifying and supporting under-served therapeutic areas. As pioneers in iron-based therapies, we have, and continue to demonstrate strong scientific, regulatory and commercial expertise to identi-fy opportunities that help create, develop and mature markets. We understand what it means to take calculated risks, and to determine the next best breakthrough for our patients and our innovative medical treatments.

As a respected industry partner, our unique business model enables us to target specific geographies and achieve direct access to patients through the capabilities, skills and infrastructure of our global partnerships. We have product license agreements with both large healthcare and small biotechnology companies, and constantly review opportuni-ties to further broaden our portfolio. Our pioneering spirit and our partnership-driven business model go hand-in-hand: we identify the biggest opportunities of unmet medical needs, and together with our partnerships make a positive difference for patients.

Our ability to work successfully with key partners across the world has enabled us to strengthen ties with patients, healthcare professionals and payers – to drive innovation, build awareness and allow patients access to the treatments they need and deserve. We know that our most valuable resource in helping patients is our people, and so seek to cultivate a unique, resilient and agile culture, bringing our values of Entrepreneurship, Respect and Teamwork to life. By listening to the patients we serve, and enabling our employees to achieve their full potential, we can accomplish our vision of becoming global leader in iron deficiency, nephrology and cardio-renal therapies.

We recognize our wider responsibilities as a global pharmaceutical company and are committed to conducting business with

integrity. By engaging with patients, valuing our employees, caring for the environment and supporting communities, we demonstrate our determination to lead by example and to remain at the forefront of our industry.

During the COVID-19 pandemic, we demon-strated the spirit of innovation, flexibility and forward-thinking on which Vifor Pharma has built its success. It underlined our commit-ment to putting patient health and quality of life at the heart of everything we do. We rapidly implemented measures to protect patients by securing continuity of product supplies, at the same time as ensuring the health and wellbeing of our employees and partners, and the communities in which we operate. We are proud of the dedication of our colleagues in manufacturing, quality control, supply chain and many other func-tions, whose hard work ensured our medicines continued to reach patients and healthcare providers in such challenging conditions. We also took steps to protect patients and caregivers involved in clinical trials, fully complying with regulatory guidance.

Vifor Pharma worked closely with the Europe-an Federation of Pharmaceutical Industries and Associations (EFPIA) and other partners to help meet the health challenges of COVID-19. Our Patient Advocacy team offered support and guidance to patient organizations, and we launched a global fund to support patient groups, with particular emphasis on improv-ing patients’ health and quality of life while restrictions were in place.

O U R M A R K E T S

Around one in three people worldwide is affected by iron deficiency1 and the market for therapies has grown substantially over the past 25 years. Vifor Pharma is committed to driving further growth by raising awareness of the symptoms and serious health conse-quences of iron deficiency, ensuring that many


more patients receive appropriate treatment. Nephrology is also a large and expanding market, with chronic kidney disease (CKD) affecting more than one in ten of the global population1. Vifor Pharma and our joint company Vifor Fresenius Medical Care Renal Pharma (VFMCRP) are dedicated to meeting the significant unmet needs of patients living with comorbidities linked to CKD. The car-dio-renal patient population is a natural extension of our existing therapy area focus in both nephrology and cardiology. Vifor Pharma is well positioned to unlock significant growth potential, by addressing underserved co-mor-bidities such as iron deficiency and hyperkale-mia in cardio-renal patients.

O U R B U S I N E S S M O D E L

Partnering and in-licensing is the cornerstone of Vifor Pharma’s growth strategy. Our therapies are sold in more than 100 countries through our own commercial expertise in key markets and best-in-class partnerships that increase our global reach. Working with others also enables us to continually expand our innovative portfolio of iron deficiency,

1 PLOS ONE. 2016 Jul 6;11(7):1–18.

nephrology and cardio-renal therapies, acquiring and in-licensing novel late-stage assets and creating mutually beneficial joint ventures. This approach complements our own early-stage R&D capabilities in iron chemistry and biology.

We have formed successful collaborations with leading pharmaceutical companies including American Regent, Inc., Daiichi Sankyo Co. Ltd, F. Hoffmann-La Roche AG, Fresenius Medical Care AG & Co KGaA, Fresenius Kabi AG, Janssen Pharmaceuticals, Inc., Kissei Pharmaceutical Co., Ltd, Pfizer, Inc., and Zeria Pharmaceutical Co., Ltd, and with innovative biotechs such as Akebia Therapeu-tics, Inc., Angion Biomedica Corp., Cara Therapeutics, Inc., Chemo Centryx, Inc., Evotec SE and OPKO Health Inc.

Our leading position in nephrology is built on our unique joint company VFMCRP, which for over ten years, has combined Vifor Pharma’s extensive and growing portfolio of nephrolo-gy medicines with Fresenius Medical Care’s global leadership in dialysis clinics and services. VFMCRP’s distinctive model in turn makes it a highly attractive commercial partner for companies with innovative ne-phrology therapies.


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O U R T H E R A P Y A R E A S


Vifor Pharma has pioneered the development of iron-based products and established itself as a global leader in the treatment of iron deficiency. Our leadership is built on our scientific, regulatory and commercial exper-tise, resulting in the creation of globally-trust-ed brands including Venofer® and Maltofer® and our strategic growth driver Ferinject®, known as Injectafer® in the US.

Iron is a fundamental mineral needed to produce hemoglobin, a protein in red blood cells that carries oxygen around the body, and a key element of energy metabolism. Iron plays a vital role in the process by which cells make energy. Human cells require iron in order to convert energy from food, and low iron means less energy can be produced. This is often why people feel tired and fatigued.

If iron levels fall too low and are not repleted, the body is unable to produce adequate amounts of hemoglobin and healthy red blood cells. Iron Deficiency is a highly preva-lent and potentially very serious condition that can have a significant negative impact on health and wellbeing. Iron deficiency and iron deficiency anemia affect those suffering from chronic diseases such as chronic heart failure, chronic kidney disease (CKD) and inflammato-ry bowel diseases. Women of reproductive age, and those who are pregnant or have recently given birth, are especially suscepti-ble. Despite high prevalence and potentially serious consequences, iron deficiency and iron deficiency anemia remain under-diag-nosed and under-treated.

Vifor Pharma believes there are significant opportunities to further expand the use of our intravenous and oral iron products, both in key therapy areas and geographically. With our partners, we are committed to increasing awareness of iron deficiency and iron deficien-cy anemia and the impact on people’s lives.

We are continuously strengthening our medical education activities to better inform clinicians about treatment options. We are also generating extensive clinical data in areas of high unmet medical need, including those with major growth potential such as chronic heart failure, CKD and patient blood manage-ment (PBM). Iron deficiency and iron deficien-cy anemia management plays a key role in PBM. It is a fast-growing field, designed to improve surgical and medical outcomes by optimally managing and preserving a patient’s blood.

N E P H R O L O G Y

Vifor Pharma is committed to helping nephrol-ogy patients around the world by offering the widest range of innovative products and solutions for conditions related to declining renal function. These include renal anemia management; mineral and bone disease management; kidney protection; and condi-tions associated with kidney impairment and its treatment. Our highly diversified portfolio includes Ferinject®/Injectafer®, Veltassa®, Venofer®, Mircera®, Retacrit®, vadadustat, Velphoro®, Rayaldee®, Invokana®, avacopan, difelikefalin and most recently ANG-3777.

CKD is common among adults, with preva-lence of up to 13.4%2 and rising as the popula-tion ages. Diabetes and hypertension are the main contributors to the risk factors for CKD, which cannot be reversed. Medication is often used to treat complications and slow further kidney damage.

Our presence in the global nephrology market is primarily through the unique joint company VFMCRP, combining our pharmaceuticals expertise with the skills and infrastructure of Fresenius Medical Care, the world’s leading

2 Hill NR et al PLOS ONE, DOI:10.1371/journal.pone.0158765

H I G H L I G H T S


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Rayaldee®

vadadustat

avacopan

difelikefalin

ANG-3777

I R O N D E F I C I E N C Y N E P H R O L O G Y C A R D I O - R E N A L

L E A D I N G P O R T F O L I O


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O U R T H E R A P Y A R E A S

provider of products and services for people with chronic kidney failure. The collaboration gives Vifor Pharma access to an extensive patient pool, with patient management systems ensuring the best outcomes for patients as well as improving standards of care for future generations.

C A R D I O - R E N A L

Vifor Pharma aims to become a significant provider of cardio-renal therapies, initially through Ferinject®/Injectafer® and Veltassa®.

Cardio-renal addresses the interplay between the heart and kidneys, where the condition or treatment of one organ can impact the other. A multi-specialty approach involving cardiolo-gists, nephrologists and internal medical physicians is key to delivering optimal out-comes for patients. Co-morbidities, such as iron deficiency and hyperkalemia, are recog-nized as common and important clinical issues for cardio-renal patients.

Ferinject®/Injectafer® has a proven record in the treatment of iron deficiency and iron deficiency anemia in heart failure3 and CKD4. Iron deficiency affects approximately 50% of people with heart failure and up to 70% of those with CKD. Iron deficiency increases morbidity and mortality risk in cardio-renal patients. Treatment of iron deficiency in cardio-renal patients5 with Ferinject® has resulted not only in improvement to symp-toms, quality of life and exercise capacity6, but also significantly reduces the risk of subsequent hospitalizations in patients with heart failure.7

3 Klip IT et al Am Heart J. 2013 Apr;165(4): 575–582.e34 Fishbane S et al Clin J Am Soc Nephrol 2009 Jan:

4(1): 57–615 Klip IT Eur J Heart Fail 2014 doi:10.1002/ejhf.846 Ponikowski P Eur J Heart Fail 2015 doi: 10.1002/ejhf.2297 Anker, S.,D. (2018). Effects of ferric carboxymaltose on

hospitalisations and mortality rates in iron-deficient heart failure patients: an individual patient meta-analysis. Eur J Heart fail. 20(1):125-133. doi: 1002/ejhf.823

In the AFFIRM-AHF study, despite narrowly missing statistical significance on the primary endpoint, treatment of iron deficiency in cardio-renal patients with Ferinject® was associated with a reduced risk of subsequent hospitalizations in stabilized patients hospital-ized for acute heart failure.

Vifor Pharma is focused on the treatment of hyperkalemia with Veltassa®, the first therapy for the condition approved in the US and Europe. Hyperkalemia is a significant market opportunity for Vifor Pharma, with an esti-mated three million patients affected in both the US8 and Europe9, and a further one million in Japan10.

Hyperkalemia, or abnormally elevated levels of potassium in the blood, is a serious prob-lem for cardio-renal patients. It can lead to cardiac arrhythmias, cardiac arrest and death, with a mortality rate of up to 30%. Recurrent hyperkalemia occurs frequently in CKD patients who also suffer from hypertension or diabetes, with or without heart failure.11 It is often triggered by treatment with RAASi (renin-angiotensin-aldosterone system) inhibitors, a cornerstone of treatment for conditions12 including hypertension and heart failure. As a consequence, RAASi therapy is often reduced or discontinued, compromising cardio-renal protection. A key goal of treat-ment with Veltassa® is to enable patients to remain on RAASi therapy by managing their chronic hyperkalemia.

8 USRDS 2013 ADR, CDC.9 De Nicola et al Nephrol Dial Transplant (2016) House

AJKD Vol 72 | Iss 2 | August 2018. 31: 335–33610 Saito Y et al. PLoS ONE 12 (9): e0184402. 2008

ESC Heart Failure 2016; 3: 145–151 31: 335–33611 Einhorn LM et al Arch Intern Med. 2009;169(12):

1156–116212Ponikowski P Eur J Heart Fail 2015 doi: 10.1002/ejhf.229



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P E R F O R M A N C E O V E R V I E W

K E Y P R O F I T O R L O S S F I G U R E S 1

Vifor Pharma Group reported net sales of CHF 1,705.6 million, a decline of 1.1% com-pared to the previous year, or an increase of 3.7% at constant exchange rates (CER). The growth was impacted by COVID-19 restrictions which mainly affected Ferinject®, with patients requested not go to hospitals, temporary closures of administration sites and delays in elective surgeries.

EBITDA increased to CHF 575.8 million compared to CHF 485.0 million in the previous year, an increase of 18.7%, or 29.4% at CER. The growth was driven by a combination of the growth in net sales at CER, cost containment measures, and the increase in other income from partnering activities and the disposal of non-core products. In the second half of 2019, the Group made changes to its defined benefit pension plan (IAS 19) which resulted in a positive one-off EBITDA impact of CHF 22.4 million in 2019. Excluding the IAS 19 impact, the EBITDA grew by 35.7% at CER compared to prior year.

Other income grew to CHF 96.4 million from CHF 37.0 million in the previous year. The increase was primarily related to the partner-ing of Ferinject® in China, Veltassa® in China and Canada, Velphoro® in Canada, and the disposal of non-core products in Spain and Portugal.

Cost of sales amounted to CHF 701.2 million compared to CHF 700.8 million in the previous year, resulting in a gross profit margin of 61.1% compared to 60.2% in the previous year. The margin improvement was driven by the higher contribution from other income.

Marketing and distribution expenses amounted to CHF 403.8 million compared to CHF 435.7 million in the previous year, down 7.3%. The additional investments in pre-launch activities for our pipeline products were more than offset by cost containment measures.

1 On 30 September 2020, the Group completed the sale of OM Pharma. Therefore OM Pharma is presented as a discontinued operation and the prior period profit or loss figures are restated accordingly.

Investments in research and development amounted to CHF 250.0 million compared to CHF 212.0 million in the previous year. The increase was attributable to the impairment of the CCX140 intangible asset of CHF 56.2 million. Excluding this impairment, investment in research and development declined by 8.6%, mainly driven by a temporary COVID-19 halt in the enrolment of patients to the Veltassa® DIAMOND clinical trial.

General and administration expenses amounted to CHF 155.7 million compared to CHF 137.6 million in the previous year. The increase was mainly attributable to higher legal costs from patent litigations of CHF 9.8 million, as well the portion of the previously mentioned changes the Group made to its defined benefit pension plan in 2019. This contributed to one-time lower general and administration costs of CHF 4.3 million in the prior year.

The average number of full-time employees (FTE) amounted to 2,429 in 2020, compared to 2,438 in 2019. This slight reduction was achieved despite the investments required to support the forthcoming launches of the pipeline products.

Depreciation, amortization, and impair-ment amounted to CHF 284.4 million com-pared to CHF 209.1 million in the previous year. Of these amounts, CHF 192.1 million and CHF 173.8 million, respectively, are recorded under cost of sales. The increase of CHF 75.3 million compared to 2019 is due to the aforementioned impairment of the CCX140 intangible asset of CHF 56.2 million, higher amortization related to product intangible assets of CHF 7.1 million and higher deprecia-tion of production equipment and IT infra-structure of CHF 5.3 million.

The net financial result amounted to an expense of CHF 22.7 million, compared to CHF 15.0 million in the previous year. The increase of financial expenses compared to previous year is mainly due to unrealized USD foreign currency losses on cash positions of CHF 21.2 million.

H I G H L I G H T S


Tax expense amounted to CHF 27.1 million compared to CHF 38.1 million in the previous year. The decrease is mainly due to the fact that the deferred tax assets at the end of 2019 needed to be revalued as a consequence of the Swiss tax reform. This resulted in a negative tax expense of CHF 12.5 million in 2019. The effective tax rate amounted to 10.2% in 2020 (2019: 14.6%).

Net profit attributable to non-controlling interests decreased from CHF 114.7 million to CHF 98.9 million, mainly due to the propor-tionate impact of impairing the CCX140 intangible asset which was partly offset with a higher contribution from other income.

Net profit after minorities increased to CHF 359.6 million compared to CHF 159.1 million in the previous year. The significant increase was mainly driven by the post-tax gain on sale of OM Pharma of CHF 190.6 million.

Core earnings per share from continuing operations amounted to CHF 4.99, an increase of 28.7% compared to CHF 3.88 in 2019 mainly due to strong operational performance. Core earnings are defined as reported earnings after minorities adjusted for propor-tionate amortization and impairment of intangible assets of CHF 185.0 million in 2020 (2019: CHF 143.5 million).

O M P H A R M A S A L E

On 30 September 2020 the sale of OM Pharma was successfully completed for a purchase consideration of CHF 435.0 million, leading to a post-tax gain on sale of CHF 190.6 million. In addition, an earn out agreement was entered into with the buyer granting Vifor Pharma the right to participate in 20% of the potential future value increase of the OM Pharma business. The earn out asset was recognized in the balance sheet at a fair value of CHF 50.0 million, this was calculated on a probability adjusted net present value basis.

C A S H F L O W S

Cash flow from operating activities amounted to CHF +423.8 million compared to CHF +524.8 million in the previous year.

The decrease is mainly due to investments in networking capital, namely increased trade receivables from phasing of payments due from major customers and a planned inventory build.

Cash flow from investing activities amounted to CHF +52.4 million. The cash inflow of CHF 400.0 million from the sale of OM Pharma was largely reinvested in upfront and milestone payments for in-licensing agreements of CHF –193.5 million as well as the Priority Review Voucher of CHF –107.7 million.

Cash flow from financing activities amount-ed to CHF –268.4 million and was mainly influenced by dividend distributions of CHF –219.6 million, whereof CHF –90.0 million was paid to Fresenius Medical Care and CHF –129.6 million was distributed to share-holders of Vifor Pharma.

F I N A N C I A L P O S I T I O N

Vifor Pharma Group achieved a net cash position of CHF 190.6 million at the end of 2020 compared to a net cash position of CHF 5.7 million at the end of 2019. The increase is mainly from the aforementioned strong operating cash flow and sale of OM Pharma, more than offsetting the dividend distributions and investments.

Goodwill and intangible assets amounted to CHF 2,454.5 million at the end of 2020 compared to CHF 2,584.5 million at the end of 2019, representing 47.1% of total assets (2019: 52.4%). The decrease is mainly due to the disposal of intangible assets of CHF 156.6 million with the sale of OM Pharma.

Financial assets amounted to CHF 725.7 million at the end of 2020 compared to CHF 510.7 million at the end of 2019. The increase is mainly due to the fair value gain on our equity investments in ChemoCentryx, Inc. as well as the additional investment in Cara Therapeutics as part of the license agreement which was announced in October.

With CHF 4,017.6 million of shareholders’ equity, Vifor Pharma Group had a strong equity ratio of 77.1% at the end of 2020 (2019: 75.7%).


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F E R I N J E C T ® / I N J E C T A F E R ®

Ferinject®/Injectafer® (ferric carboxymaltose) is a world-leading intravenous (i.v.) iron therapy with market approval in 83 countries and 49.5% share by value in the i.v. iron segment of the iron market1 by value in 20202. In the US and Belgium, Ferinject® is commer-cialized under the brand name Injectafer®. The product’s blockbuster status was con-firmed in 2020, despite the global impact of the COVID-19 pandemic.

Ferinject®/ Injectafer® continues to address the significant unmet medical need for treatment of patients with iron deficiency and iron deficiency anemia in key therapy areas, including chronic heart failure, patient blood management (PBM), nephrology, gastroenter-ology, oncology and women’s health. Affect-ing up to one third of the global population, iron deficiency and iron deficiency anemia are serious conditions with a wide range of debilitating symptoms which can result in a significant impact on patients’ quality of life.

More than 16 million patient years of experi-ence have helped to establish Ferinject®/ Injectafer® as a trusted brand, with clinical benefits demonstrated by its efficacy and safety data3. To deliver i.v. iron to the body, Ferinject®/Injectafer® is designed as a complex nanomedicine consisting of nano-particles, with an iron core wrapped by a carbohydrate shell. These nanomedicines are even bigger and more complex in structure

1 Without prejudice to market definition.2 Unlike volume data, value data are unrepresentative of

competitive dynamics because they sum different types of prices for different medicines.

3 Scott Drugs. 2018 Mar;78(4):479–493. doi: 10.1007/s40265-018-0885-7.

than biologics. The term “Non-Biological- Complex-Drugs” (NBCDs) was therefore introduced for this category of medicines.

In contrast to small molecules or biologics, nanomedicine products have a physico- chemical structure which is hard to character-ize and best defined by the manufacturing process. In addition to the chemical composi-tion of Ferinject®/Injectafer®, the particles’ physical properties define its interaction with the human body and therefore its therapeutic benefit. This complex set of physical chemical characteristics is dependent on Vifor Pharma’s well-established proprietary manufacturing process, and as a consequence, clinical data developed with Ferinject®/ Injectafer® cannot just be extrapolated to other i.v. iron complexes.

Nanomedicines are recognized by regulatory authorities, including the FDA in the US, as harder-to-copy complex products with potential regulatory or scientific issues which should be addressed during the approval procedure for follow-on products.4,5 Euro pean Regulatory Authorities acknowledged the complexity of nanomedicines and recently applied the hybrid pathway to grant marketing authorization for follow-on products of nanomedicines.6 This “hybrid” regulatory

4 U.S. Food and Drug Administration: Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines. Available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-2019- efforts-advance-development-complex-generics

5 EMA/CHMP/SWP/620008/20126 Klein, K., Stolk, P., De Bruin, M. L., Leufkens, H. G. M.,

Crommelin, D. J. A., & De Vlieger, J. S. B. (2019). The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations. European Journal of Pharmaceutical Sciences. 15;133:228–235.

P O R T F O L I O

FERINJECT®/INJECTAFER® SHARE BY VALUE IN THE I.V. IRON SEGMENT OF THE IRON MARKET

49.5%


https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-2019-efforts-advance-development-complex-generics

pathway authorization depends partly on the results of tests on the reference medicine, and partly on new data.7

I M P A C T O F C O V I D - 1 9

In 2020, countries around the world imposed social and economic restrictions in response to the COVID-19 pandemic, impacting all industry sectors including healthcare. Thanks to business continuity plans and inventory procedures, Vifor Pharma was able to ensure uninterrupted supply of key medicines while keeping its employees, communities and partners safe.

The pandemic resulted in fewer patients visiting healthcare providers, temporary closures of administration sites for i.v. iron infusion and delays in elective surgeries. During the course of the year, key therapy areas were impacted to varying degrees, with

7 ema.europa.eu/en/human-regulatory/marketing-authori-sation/generic-hybrid-medicines

treatment for patients with life-threatening conditions or requiring emergency proce-dures prioritized over those with non-life threatening conditions.

Treatment for women with peri- and postpartum iron deficiency anemia remained largely unaffected, as did treatment for essential medical procedures, such as non- dialysis CKD patients and those undergoing oncologic therapy. Major elective surgeries were reduced in 2020, impacting Ferinject® sales in Patient Blood Management (PBM). Treatment of iron deficiency and iron deficiency anemia in chronic heart failure patients was impacted to a similar extent. As a consequence, overall sales of Ferinject®/ Injectafer® were below expectations to continue strong growth in the high double digit millions, in both hospital and retail settings. With a strong correlation between i.v. iron utilization and the intensity of lockdown measures in 2020, we expect a return to pre-pandemic growth rates as soon as restrictions are lifted.


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https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/generic-hybrid-medicines

N E T S A L E S I N 2 0 2 0

Net sales of Ferinject®/Injectafer® decreased to CHF 552.2 million in 2020, down –1.6% from CHF 561.0 million in the previous year, and growing 3.0% at constant exchange rates.

Sales returned to growth in Q3 after declines in Q2, as COVID-19 restrictions eased in many markets improving patient access to infusions. In the final quarter of the year, sales were again impacted by heightened restrictions across much of Europe following a second wave of infections. I.v. iron utilization was highly correlated with the intensity of lockdown measures throughout 2020, and recovery is expected as COVID-19 restrictions are lifted.

I N - M A R K E T S A L E S I N 2 0 2 0

Vifor Pharma closely monitors in-market sales to determine actual growth rates of Ferinject®/Injectafer®. The latest available data showed global in-market sales of CHF 1.005 billion in 2020, up 0.1% from the previous year. In-market sales of Injectafer® in the US were CHF 448.3 million in 2020, down from CHF 502.4 million in 2019.

I N J E C T A F E R ® ( U S )

In the US, Injectafer® continues to be a market leader by volume in the treatment of iron deficiency anemia in hematology, oncology and gastroenterology, with growth potential in areas of heart failure, women’s health and nephrology. Vifor Pharma’s US partner American Regent, Inc., a Daiichi Sankyo Group company, recorded net sales of USD 415.5 million in 2020, a slight decline of –6.6% compared to the prior year. This was due to state and federal lockdown restrictions and limitations on infusion procedures due to the pandemic. As a result, Vifor Pharma reported net sales of CHF 138.3 million in 2020.

Injectafer® continued to demonstrate utiliza-tion in iron deficiency anemia in all key therapy areas of internal medicine, gastro enterology and nephrology. There is still a significant opportunity for market growth in the US, and American Regent has continued work to build future growth in multiple therapeutic areas, including heart failure and women’s health.

T H E R A P Y A R E A S W I T H H I G H U N M E T N E E D

Chronic Heart FailureVifor Pharma continues to invest in additional clinical studies to demonstrate the efficacy and safety of Ferinject®/Injectafer® treatment in different patient groups. One in every two chronic heart failure patients has iron deficien-cy or iron deficiency anemia, associated with reduced quality of life, reduced exercise capacity and increased risk of hospitalization. With the majority of heart failure patients with the condition either not diagnosed or inade-quately treated, this therapy area is a key focus for ongoing further campaigns to increase disease awareness and utilization of Ferinject® as a guideline recommended treatment.8

A major milestone for Vifor Pharma in 2020 was the successful completion of the AFFIRM-AHF study. In November, results from the AFFIRM-AHF trial were presented at the 2020 American Heart Association (AHA) Scientific Sessions virtual congress. Simulta-neously, results were also published in the peer-reviewed medical journal “The Lancet”.

The study evaluated the effect of Ferinject® on heart failure hospitalizations and cardio-vascular mortality in iron-deficient patients after hospital stabilization for acute heart failure (AHF). Recently admitted patients with AHF are among the most fragile patients, with poor prognosis and frequent re-admissions to hospital. The study reported a clinically

8 Ponikowski P, et al. Eur Heart J. 2016;37(27):2129−2200.



83

F E R I N J E C T ® / I N J E C T A F E R ® A P P R O V E D I N 8 3 C O U N T R I E S W O R L D W I D E

16MILLIONYEARS OF PATIENT EXPERIENCE(APPROX.)

P A T I E N T S

1.005BILLIONFERINJECT®/INJECTAFER® GLOBAL IN-MARKET SALES

M A R K E T S A L E S

I R O N P R O D U C T S

Vifor Pharma has been a pioneer in the development of iron-based products and has established itself as a global leader in the treatment of iron deficiency and iron deficiency anemia.

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23Vifor Pharma Ltd. Annual Report 2020

significant reduction in hospital readmissions due to heart failure among patients treated with Ferinject® compared to placebo. After 52 weeks, patients who received iron supple-mentation were 26% less likely to be re-admit-ted to hospital for heart failure compared to placebo, after only one or two injections of Ferinject® [RR 0.74; 95% CI 0.58-0.94; p=0.013]. Overall, AFFIRM-AHF narrowly missed the conventional 5% statistical significance on the primary composite endpoint, but numerically reduced total cardiovascular death and heart failure re-hospitalization events by 21% [RR 0.79; 95% CI 0.62-1.01; p=0.059]. Total mortali-ty and death from cardiovascular causes were similar between groups [RR 0.96; 95% CI 0.70-1.32]. The COVID-19 pandemic resulted in signifi-cant disruption to the healthcare systems, with a 40% reduction in heart failure hospitaliza-tions in Europe between March and June 2020. Heart failure patients are particularly at risk from COVID-19. Therefore, as the trial was partially conducted during the COVID-19

pandemic, a sensitivity analysis to account for the impact of COVID-19 on the study results was pre-specified prior to study unblinding. The pre-specified analysis revealed a statisti-cally significant difference in favor of Ferinject® on the composite endpoint of cardiovascular mortality and hospitalization for heart failure.

This is the first study demonstrating the benefits of iron supplementation initiated in stabilized patients hospitalized for AHF. The study showed that administration of Ferinject® in stabilized AHF patients with iron deficiency significantly reduces the risk of subsequent HF hospitalizations, and highlights the need for AHF patients to be more frequently screened for iron deficiency.

FAIR-HF29 is an investigator-initiated study led by the University Medical Center Hamburg- Eppendorf in Germany as sponsor and supported by the German Centre for Cardio-

9 Clinicaltrials.gov



https://clinicaltrials.gov/

vascular Research, and by two research grants from Vifor Pharma to these institutions. The objective of the study is to show that treat-ment of patients with systolic heart failure and iron deficiency with i.v. iron (Ferric Carboxy-maltose, FCM) versus placebo (i.v. NaCl) can reduce the rate of the combined endpoint of recurrent heart failure hospitalizations and cardiovascular death during at least 12 months of follow up.

Vifor Pharma’s US partner American Regent is also conducting one of the largest studies of i.v. iron in heart failure, the HEART-FID study. HEART-FID is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the efficacy and safety of Injectafer® in the treatment of patients with heart failure with reduced ejection fraction in iron deficiency patients. Enrolment in this study continued in 2020, and is expected to be completed in 2022.10

Patient Blood ManagementPatient blood management (PBM) is key therapy area with high growth potential. It is designed to improve surgical and medical patient outcomes by optimally managing and preserving patients’ blood. Proactive identification and treatment of iron deficiency anemia in patients scheduled for elective surgery has been asociated with a reduced need for blood transfusion, reduced the length of hospital stay, and improved medical outcomes. Vifor Pharma aims to be a key partner for hospitals to support PBM imple-mentation and to make it a standard of care practice. It is estimated that about 1.9 million patients could benefit from PBM in the EU’s five largest countries.

10 Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID) (2019). Available at https://clinicaltrials.gov/ct2/show/NCT03037931

Vifor Pharma is conducting a real-world evidence study analyzing the clinical and economic impact of implementing PBM measures with Ferinject®. Approximately 31,000 patients are enrolled from four Europe-an countries, including the UK, Germany, Italy and Spain. Vifor Pharma plans to generate definitive evidence to show the beneficial impact of Ferinject® on a number of clinical and Health economics and outcomes research (HEOR) indicators. Preliminary results are expected at the end of 2021. Following results, the expectation is to launch a multi-channel campaign for disseminating the benefits of PBM, addressing multiple stakeholders such as HCPs, payers and hospital managers.

The COVID-19 pandemic reduced the number of patients undergoing elective surgeries in 2020. It also resulted in a dramatic reduction in blood donations around the world, poten-tially putting the lives of patients who needed blood at risk. This has led to organizations including the European Centre for Disease Control (ECDC), the Society for the Advance-ment of Blood Management (SABM) and the American Society of Anesthesiologists (ASA)11 recommending PBM principles be followed. They have also highlighted anemia manage-ment and iron replacement therapies as key interventions to overcome blood shortages caused by the pandemic. Vifor Pharma continuously emphasizes the importance of implementing PBM to improve clinical outcomes by optimally managing patients’ blood and works to educate governments and healthcare providers of its value.

In February 2020, the World Health Organiza-tion released an updated strategic action framework to advance universal access to safe blood, including PBM as one of their six strategic objectives. In addition, the European

11 Off-label in the US


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https://clinicaltrials.gov/ct2/show/NCT03037931

Commission announced plans to revise the EU Blood Directive in 2021. Vifor Pharma will continue to highlight the importance of including PBM in the directive. In the UK, pre-operative iron deficiency screening and treatment was promoted by the NHS’ Com-missioning for Quality and Innovation.

Nephrology Vifor Pharma launched an accredited online medical education campaign via Medscape in 2020, to raise awareness of the risks associat-ed with iron deficiency and the benefits of i.v. iron treatment in patients with non-dialysis dependent chronic kidney disease (ND-CKD). Attendance and program completion by nephrologists exceeded the company’s set target and the industry benchmark for online CME programs. A continuing Medical Educa-tion (CME) Satellite Symposium at the virtual European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) meeting in June 2020 was supported by Vifor Pharma. The symposium educated nephrologists about treating iron deficiency early in patients with CKD and concomitant heart failure.

Medical education continued throughout 2020, and included medical publications and a multichannel digital campaign in selected European countries. In the second half, Vifor Pharma launched two more online CME modules, further emphasizing the importance of treating iron deficiency in ND-CKD patients. The company continues to invest in real-world evidence generation to show improved health economic outcomes in patients treated with Ferinject® compared to patients treated with either oral iron or low-dose iron, including ongoing studies in France and Italy.

Women’s Health Vifor Pharma supported Women Political Leaders Global Forum in 2020 with the launch of a gender-sensitive information toolkit addressing the impact of iron deficiency and iron deficiency anemia in women. An analysis of current disease burden and management strategies shows insufficient awareness of the issue and inadequate resources dedicated to dealing with it. In nearly all countries, iron deficiency and iron deficiency anemia remain a moderate to severe health risk, dispropor-tionately affecting women. Up to 50% of pregnant women are iron-deficient, and 42% of pregnant women and 30% of non-pregnant women live with iron deficiency anemia.

The toolkit was launched at the Reykjavik Global Forum – Women Leaders 2020 during a session on Driving Equality for a Healthy Society. Vifor Pharma was proud to participate in this event, which marked one of the most important conferences aimed at improving gender equality in 2020. The Vifor Pharma- sponsored session saw the participation of patient advocates, physicians and policy makers, who discussed ways of improving standards of care for women impacted by bleeding disorders and during pregnancy.

Other disease awareness initiativesOn Iron Deficiency Day, 26 November 2020, Vifor Pharma’s annual international awareness initiative was promoted in 27 countries around the world. Running for the sixth year, this global campaign is designed to educate patients, key opinion leaders, healthcare pro viders and the general public to #TakeIronSeriously and understand the symptoms and treatment options for iron deficiency and iron deficiency anemia. Vifor Pharma partnered with a range of international organizations, including the European Kidney Health Alliance, The Heart Failure Policy Network, Croi, Global Heart Failure Hub and the Anemia Community.



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G E O G R A P H I C E X P A N S I O N

ChinaIn February 2020, Vifor Pharma announced a strategic partnership with Fresenius Kabi in China, expanding its existing alliance with the Fresenius Group and gaining improved access to the second largest pharmaceutical market in the world. As part of the agreement, Vifor Pharma and Fresenius Kabi created a joint company to focus on marketing, market access and medical affairs activities for Vifor Pharma’s i.v. iron portfolio. The joint company is 55% owned by Vifor Pharma and 45% by Fresenius Kabi.

The focus of the partnership is on PBM to benefit both patients and the healthcare system in China, with an estimated 3-5 million patients undergoing elective surgery each year. Fresenius Kabi will be fully responsible for the sales of Vifor Pharma’s i.v. iron portfolio, covering more than 20,000 anesthesiologists and 25,000 surgeons in more than 2,000 large scale hospitals to support PBM, as well as working with healthcare professionals for other indications including nephrology.

There is a high unmet medical need for Vifor Pharma’s i.v. iron products in China, which has the world’s largest iron deficiency anemia population, with an estimated prevalence of 20%. Following positive phase-III trial results, a New Drug Application (NDA) for Ferinject® was filed and the submission was accepted by China’s National Medical Products Administra-tion in June 2020.

JapanIn Japan, our partner Zeria Pharmaceutical Co., Ltd. was granted reimbursement in August 2020, and launched Ferinject® commercially in September.

Recent data estimates the number of patients diagnosed with iron deficiency anemia in Japan at 4.9 million a year. Of these, some

2.2 million patients are treated with oral and i.v. iron preparations by specialists in gynecology, gastroenterology, cardiovascular and kidney internal medicine.12 Until recently, only one low-dose i.v. iron formulation has been avail-able in Japan, limiting treatment options and highlighting a significant unmet medical need.

Despite launching during pandemic-related restrictions, with limited hospital access and a decline in the number of patients visiting practitioners, positive feedback has been received from early prescribers who recognize the clinical benefits of Ferinject® on their patients. This signals high satisfaction and further adoption in the market. The fast correction of both haemoglobin and ferritin, the reduction of symptoms and limited number of administrations, are considered revolutionary in a country where iron deficien-cy anemia has often been considered chronic or inevitable. Ongoing investment is being made in medical education to raise aware-ness of the importance to treat and correct iron deficiency anemia, and expectations on patients’ quality of life and well-being.

12 Japan Medical Data Center (JMDC) P-Market (April 2018-March 2019).


STRATEGIC PARTNERSHIP WITH FRESENIUS KABI IN CHINA

WITH PARTNER ZERIA PHARMACEUTICAL

GEOGRAPHICEXPANSION


M A LT O F E R ®

Maltofer® is the originator oral iron polymaltose complex (IPC), and plays an important role in the management of patients with iron defi-ciency. Registered in 79 countries, Maltofer® is a widely accepted and well-tolerated therapy for infants, children, adolescents and pregnant women. It is a market leading oral iron product in a fragmented market, with over 3,000 global suppliers. In 2020, the products global share by value13 was 7.8% in the oral iron segment of the iron market14.

In 2020, net sales of Maltofer® increased by 4.7% compared to the prior year to CHF 62.8 million. This increase was primarily driven by strong growth in Saudi Arabia and Australia.

A new global campaign called “Your Iron Counts” was launched in the second half of 2020, with the intention to empower women during pregnancy and in postpartum to take their iron levels seriously, and to encourage physicians to monitor iron levels consistently. The campaign is expected to positively impact the product’s performance.

13 Unlike volume data, value data are unrepresentative of competitive dynamics because they sum different types of prices for different medicines.

14 Without prejudice to market definition.

MALTOFER® GLOBAL SHARE BY VALUE IN THE ORAL IRON SEGMENT OF THE IRON MARKET

7.8%

COUNTRIES

79REGISTERED IN


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O U R P O R T F O L I O

N E P H R O L O G Y

N E P H R O L O G Y

Vifor Pharma’s highly diversified nephrology portfolio is built around five primary disease areas, focusing on distinct comorbidities and complications in chronic kidney disease (CKD) patients. This includes renal anemia manage-ment, mineral and bone disease management, kidney protection and improvement, CKD- associated complications, acute kidney injury and transplantation.

Our expanding presence in the global nephrology market is primarily built around the unique joint company Vifor Fresenius Medical Care Renal Pharma (VFMCRP), which for the last ten years, has combined Vifor Pharma’s expertise in pharmaceuticals with the skills and infrastructure of Fresenius Medical Care. Fresenius Medical Care has access to almost 350,000 patients in its global network of over 4,000 dialysis clinics, and is the world’s leading provider of products and services for people with chronic kidney failure. The joint company’s objective is to provide a portfolio of products and innovative services addressing the major therapeutic needs of CKD patients, focusing on the nephrologist as the main specialist.

In 2020, the overall impact of COVID-19 on our commercial products in the nephrology portfolio was low. Dialysis and other potentially life-saving procedures have remained essen-tial for millions of chronic kidney disease patients worldwide who have continued to receive treatment. Our priority has been to maintain continuity of product supply to serve the patients who depend on us, and to

progress ongoing clinical trials in a safe environment for both patients and caregivers in accordance with health authorities’ guid-ance and recommendations. We have contin-ued to support our partner Fresenius Medical Care, to ensure delivery of dialysis to late stage CKD patients during the pandemic.

The portfolio of products which encompasses the five primary disease areas is detailed below:

R E N A L A N E M I A M A N A G E M E N T

E R Y T H R O P O I E S I S - S T I M U L A T I N G A G E N T ( E S A ) P O R T F O L I O

VFMCRP commercializes products for the treatment of anemia in patients with chronic kidney disease. The joint company’s ESA portfolio includes both short-acting and long-acting ESAs to offer customers a full range of treatment options to support patient needs.

Erythropoietin (EPO), a natural hormone produced by the kidneys, is essential for the regulation of red blood cell production. In CKD patients, kidney dysfunction often results in a deficit in the production of EPO, leading to a decline in the production of healthy red blood cells, and consequent anemia. In these cases, treatment with exogenous erythropoie-tin analogues or ESAs is recommended. While short-acting ESAs are typically administered two to three times per week, long-acting ESAs have been designed to have a much longer- lasting effect, allowing for dosing once or twice a month.


M I R C E R A®

Mircera® (methoxy polyethylene glycol-epoe-tin beta) is a long-acting ESA licensed from F. Hoffmann-La Roche AG in 2015 to treat symptomatic anemia associated with CKD. Mircera® is a core element of Vifor Pharma’s renal anemia strategy and is currently sup-plied to over 3,500 dialysis clinics in the US and its territories.

Net sales of Mircera® decreased by –8.6% to CHF 478.4 million in 2020 from CHF 523.4 million in 2019 and decreasing –3.6% at constant exchange rates. This decrease was mainly due to price consolidation in the mid-sized and independent market in the US, however its impact was partially offset by the addition of new customers in this space. An additional negative impact can be attributed to exchange rate fluctuations.

R E T A C R I T ®

Retacrit® (epoetin alfa-epbx) is a short-acting ESA approved by the US FDA in May 2018 for all indications of its reference drug, epoetin alfa. It is the first biosimilar ESA approved for use in the United States. Vifor Pharma licensed rights from Pfizer Inc. in 2015 to commercialize Retacrit® in certain channels, including the US dialysis and the majority of the non-hospital market.

Vifor Pharma’s net sales of Retacrit® grew to CHF 45.8 million in 2020, as more customers continued to adopt Retacrit® as their pre-ferred short-acting ESA. Following availability of multi-dose vials in late 2020, additional incremental growth is expected.

V E N O F E R ®

Venofer® (iron sucrose [iron (III)-hydroxide sucrose complex]) is the originator intrave-nous (i.v.) iron sucrose product, used for i.v. treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Robust clinical data and clinical experi-ence make Venofer® the trusted and preferred iron sucrose treatment in iron therapy for anemic dialysis patients. It continues to be a leading i.v. iron brand in terms of volume worldwide, with over 30 million patient years of experience by the end of 2020.

DIALYSIS CLINICS IN THE US

SUPPLIED TO OVER

3,500

MIRCERA® NET SALES

478.4MILLION CHF


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ucts can have a different efficacy and safety profile, as well as a different clinical perfor-mance, compared with Venofer®. In light of this scientific evidence, European regulatory agencies are no longer providing generic mar-keting authorizations for i.v. iron follow-on products, but approve them as nanosimilars.23 As a result, these iron sucrose similars cannot be assumed to be therapeutically equivalent to Venofer® without data to demonstrate therapeutic equivalence between Venofer® and iron sucrose similars.

V A D A D U S T A T I N D E V E L O P M E N T

Vadadustat is an investigational oral hypox-ia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in development by Akebia Therapeu-tics, Inc., a NASDAQ-listed, US bio-pharma-ceutical company. Vadadustat is in develop-ment for the treatment of anemia due to chronic kidney disease (CKD).

Pursuant to a License Agreement with Akebia, Vifor Pharma has been granted an exclusive license to sell vadadustat to Fresenius Kidney Care dialysis centers and to specific third-party dialysis organizations that together account for approximately 60% of the dialysis patients in the US. The license is subject to vadadustat’s approval by the US FDA, the earlier of reim-bursement under Transitional Drug Add-on Payment Adjustment (TDAPA) or inclusion in the Centers for Medicare and Medicaid (CMS) End-Stage Renal Disease Prospective Payment System (ESRD PPS), and a milestone payment from Vifor Pharma. If granted for vadadustat, the TDAPA is expected to be in effect for a two-year period, after which the product would be expected to be reimbursed under the ESRD PPS.

23 Public Assessment Report (2018) Sucrofer 20 mg iron/ml, Solution for injection/infusion (iron sucrose). Medicines & Healthcare products Regulatory Agency

Reported net sales of Venofer® increased to CHF 136.2 million in 2020, up 2.9% from CHF 132.4 million in 2019 and growing 8.4% at constant exchange rates. Sales of Venofer® totaled CHF 68.2 million in 2020 in the US, where it is a market-leading i.v. iron in hemo-dialysis. Global in-market sales data for Venofer® represent 22.3% share by value15 of the i.v. iron segment of the iron market16.

Venofer® is a nanomedicine recognized by the US FDA as a harder-to-copy complex product17. The complex structure, surface, composition, and sophisticated manufactur-ing of Venofer® define its individual behavior and therefore clinical outcome. It is therefore considered a non-biologic complex drug (NBCD). This is in contrast to small-molecule drugs where the physico-chemical structure cannot be fully characterized and is best defined by their proprietary manufacturing process. Emerging scientific evidence 18, 19, 20,

21, 22 has demonstrated that follow-on prod-

15 Unlike volume data, value data are unrepresentative of competitive dynamics because they sum different types of prices for different medicines.

16 Without prejudice to market definition.17 U.S. Food and Drug Administration: Statement from FDA

Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines. Available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-2019-ef-forts-advance-development-complex-generics

18 Di Francesco, T., Sublet, E., Borchard, G. (2019). Nanomed-icines in clinical practice: Are colloidal iron sucrose ready-to-use intravenous solutions interchangeable? European Journal of Pharmaceutical Sciences. 131, 69–74.,

19 Rottembourg, J., Kadri, A., Leonard, E., Dansaert, A., Lafuma, A. (2011). Do two intravenous iron sucrose preparations have the same efficacy? Nephrology Dialysis Transplantation. 26, 3262–3267.,

20 Agüera, M.L, Martin-Malo, A., Alvarez-Lara, M. A.,Gar-cia-Montemayor, V. E., Canton, P., Soriano, S., Alijama, P. (2015) Efficiency of original versus generic intravenous Iron formulations in patients on Haemodialysis. PLOS ONE. 10, e0135967.

21 Lee, E. S., Park, B. R., Kim, J.S., Choi, G.Y., Lee, J. J., Lee, I. S. (2013) Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Current Medical Research and Opinion. 29, 141–147.,

22 Bailie, G. R., et al. (2015) Data from the Dialysis Outcomes and Practice Patterns Study validate an association between high intravenous iron doses and mortality. Kidney International. 87, 162–168.,

N E P H R O L O G Y


https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-2019-efforts-advance-development-complex-generics

Akebia recently completed the global phase-III clinical development program for vadadustat. In May 2020, Akebia announced positive top-line results from INNO2VATE, its phase-III program which evaluated the safety and efficacy of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis. Within INNO2VATE, vadadustat achieved the primary and key secondary efficacy endpoints, demonstrating non-inferiority to darbepoetin alfa as mea-sured by a mean change in haemoglobin between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also achieved its primary safety endpoint, defined as time-to-first occurrence of major adverse cardiovascular events (MACE), and achieved key secondary safety endpoints including expanded MACE, cardiovascular MACE, cardiovascular mortality, and all-cause mortality.

In September 2020, Akebia announced results from its global phase-III PRO2TECT program, evaluating vadadustat’s safety and efficacy versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients not on dialysis. Vadadustat achieved the PRO2TECT program’s primary and key secondary efficacy endpoints; however, vadadustat did not meet the program’s primary safety endpoint. Pursuant to the License Agreement with Akebia Therapeutics, Vifor Pharma does not have rights to sell the product outside of the dialysis setting.

Akebia plans to submit to the FDA a New Drug Application (NDA) for vadadustat in mid-Q2 2021, for the treatment of anemia due to CKD for adult patients on dialysis and not on dialysis.


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M I N E R A L A N D B O N E M A N A G E M E N T

V E L P H O R O ®

Velphoro® (Polynuclear Iron (III)–Oxyhydroxide, Sucroferric Oxyhydroxide) is a non- calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood in adults with chronic kidney disease (CKD) on dialysis. Launched in 30 countries, over 100,000 patients are now estimated to benefit from Velphoro® on a yearly basis. In 2020, Velphoro® became a global leader by value in the calcium-free phosphate binder market.24

Velphoro® remained strong with net sales of CHF 177.7 million in 2020, a slight decrease of –2.2% from CHF 181.7 million in 2019 and growing 3.6% at constant exchange rates. Reported net sales were impacted by order patterns of a major customer in the US. Overall, in-market growth continues, with global in-market sales up by 24.8% to CHF 439.3 million in 2020, mainly driven by the US and Japan. While face-to-face contacts with physicians were significantly reduced during the pandemic, the brand maintained momentum with continued promotion and customer contacts via virtual channels.

In the first half of 2020, Velphoro® was launched in Canada by our partner Otsuka Canada Pharmaceutical Inc., and in South Korea by our partner Fresenius Medical Care Korea Ltd. In the second half of the year, Velphoro® was launched in Saudi Arabia. VFMCRP is working towards regulatory approvals in a number of South East Asian markets, with launches planned in 2021. In China, a phase-III clinical trial is expected to be completed by end of 2021, with commer-cial launch planned for H2 2023.

24 Monthly IQVIA MIDAS panel, INSIGHT Health & DN, GERS, DLI, Farminform | 03.2020

Growing real-world evidence continues to demonstrate the benefits of Velphoro® for patients, with approximately twice as many achieving and maintaining target serum phosphate levels with half the pill burden, when switched from other phosphate binders. This was confirmed in a two-year retrospective study published in the “Kidney Medicine“ in March 2020.25 The real-life data also suggests a 25% reduction in the risk for hospitalization (incidence rate per 100 patient-years).

The European Post Authorization Safety Study VERIFIE, which assessed the safety and effectiveness of Velphoro® post launch, was successfully completed in 2019. The study results also confirmed safety and effectiveness of Velphoro® in a real-life setting by doubling the patients with controlled phosphate levels 12 months after initiation. Related updates to

25 Coyne, D. W., et al. (2020) Sucroferric Oxyhydroxide in Maintenance Hemodialysis: A Retrospective, Compara-tive Cohort Study. Kidney Medicine.

GLOBAL IN-MARKET SALES UP

VELPHORO® - LEADER IN GLOBAL PHOSPHATE BINDER MARKET

VELPHORO® LAUNCHED IN CANADA AND SOUTH KOREA.

24.8%

1#

GEOGRAPHICEXPANSION

N E P H R O L O G Y


the risk management plan and the Summary of Product Characteristics were approved by the European regulatory authorities in May 2020. Post balance sheet reporting February 2021, the results were published in “Clinical Kidney Journal.”

In the US, additional patents have been listed in the Orange Book with expiration in 2028 and 2034, further strengthening the IP protection for Velphoro®. In 2018, Abbreviated New Drug Applications (ANDAs) were filed with the US Food and Drug Administration (FDA) for generic versions of Velphoro®. All disputes have been settled with the exception of one generic company, for which a trial took place in January 2021 with respect to VFMCRP’s 2030 expiring patent. A further trial is due to follow in 2022 with respect to VFMCRP’s 2028 patents. So far, no FDA approval has been issued for any generic copy.

In the European Union, Velphoro® received an extension of the indication for use in pediatric patients, and linked with this, one additional year of marketing protection with exclusivity until August 2025.

R A Y A L D E E ®P R E - C O M M E R C I A L

Rayaldee® is an orally administered, extended- release26 formulation of calcifediol, a pro-hormone of the active form of vitamin D3, for the treatment of secondary hyperparathy-roidism (SHPT) in patients with chronic kidney disease (CKD) with vitamin D insufficiency. VFMCRP obtained the rights from OPKO Health Inc. for this indication in Europe and selected markets outside the US.

SHPT is a chronic progressive disease which increases in severity as CKD worsens. It is

26 Rayaldee® is approved with the terminology “extended- release” in the US and as “prolonged-release” in the EU.

characterized by excessive secretion of parathy-roid hormone (PTH) by the parathyroid glands in response to low blood calcium levels (hypocalcemia), with resultant hyperplasia of these glands. It is estimated to affect between 40% and 82% of patients with stage three or four CKD.27 Prolonged elevations in PTH levels increase the risk of bone disease, fractures, vascular and soft tissue calcification, and therefore morbidity and mortality.28, 29, 30 Furthermore, hyperplasia of the parathyroid glands leads to increasing autonomy of parathy-roid tissues, resulting in sustained elevations in PTH, and is also accompanied by treatment resistance.31 There is currently no established standard of care for the treatment of SHPT in non-dialysis (ND-CKD) patients across Europe.

Rayaldee®’s unique extended-release formulation of calcifediol (ERC) raises serum 25-hydroxyvitamin D gradually to levels needed in CKD patients for the control of SHPT, and lowers blood levels of PTH. At the same time, it has an inconsequential effect on serum calcium and phosphate levels. This allows for the early and efficient management of SHPT without exposing the patient to significant risk of hypercalcemia and hypo-phosphatemia.

27 Levin, A., Bakris, G. L., Molitch, M., Smulders, M., Tian, J., Williams, L. A. & Andress, D. L. (2007). Prevalence of abnormal serum vitamin D, PTH, calcium, and phosphorus in patients with chronic kidney disease: Results of the study to evaluate early kidney disease. Kidney International, 71(1), 31–38.

28 Cunningham J, Locatelli F, Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options. Clin J Am Soc Nephrol. 2011;6(4):913−921.

29 Nigwekar SU, Tamez H, Thadhani RI. Vitamin D and chronic kidney disease-mineral bone disease (CKD-MBD). Bonekey Rep. 2014;3:498.

30 Lishmanov A, Dorairajan S, Pak Y, et al. Elevated serum parathyroid hormone is a cardiovascular risk factor in moderate chronic kidney disease. Int Urol Nephrol. 2012;44(2):541−547.

31 Rodriguez M, Nemeth E, Martin D. The calcium-sensing receptor: a key factor in the pathogenesis of secondary hyperparathyroidism. Am J Physiol Renal Physiol. 2005;288(2):F253−264.


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A recent study32 in the US found that clinical effectiveness and safety in a real-world setting is consistent with data reported from random-ized clinical trials. In contrast to nutritional and active vitamin D, only ERC was associated with a statistically significant decrease in PTH. In addition, patients treated with ERC saw the greatest increase in serum 25-hydroxyvitamin vitamin D levels, without a statistically signifi-cant impact on key safety outcomes (serum calcium and phosphate).33

During H2 2020, Rayaldee® received national marketing authorizations in selected Europe-an countries, including Germany, Spain, Italy and Switzerland. Vifor Pharma plans to initiate launch of Rayaldee® in late 2021/early 2022.

K I D N E Y P R O T E C T I O N

A V A C O P A NU N D E R R E G U L A T O R Y R E V I E W

Avacopan is an orally-administered, highly selective inhibitor of C5aR1 (the complement C5a receptor1), which is central to the underly-ing inflammatory cycle that drives blood vessel damage in ANCA-associated vasculitis (anti-neutrophil cytoplasmic auto-antibody-as-sociated vasculitis) or AAV. It is currently being developed for the treatment of orphan and rare renal diseases including AAV and C3 glomerulopathy (C3G). Previous studies have shown the clinical and patient experience benefits of selectively blocking C5aR1, which is responsible for pathophysiological pro-in-flammatory responses.

VFMCRP has a licensing agreement with ChemoCentryx, Inc., to commercialize

32 Germain MJ, et al. Poster presented at ERA-EDTA Virtual Congress, 6–9 June 2020.

33 Germain M, et al. Real-world assessment: clinical effectiveness and safety of vitamin D therapies in ND-CKD patients. Presented at ERA-EDTA virtual annual meeting 2020.

avacopan outside the US. Following positive topline data from the pivotal phase-III ADVOCATE trial in the treatment of AAV at the end of 2019, VFMCRP filed a Marketing Authorization Application (MAA) for the treatment of patients with AAV with the European Medicines Agency (EMA) in October 2020.

In November 2020, the EMA accepted to review the MAA for avacopan for the treat-ment of patients with AAV, granulomatosis with polyangitis (GPA) and microscopic polyangiitis (MPA), a group of rare and severe autoimmune diseases with high need for targeted therapies. The EMA is reviewing the application under the centralized marketing authorization procedure. Approval is expect-ed in H2 2021. If approved, avacopan will receive marketing authorization in all EU mem-ber states, followed by launch in late 2021/ early 2022. Avacopan would be the first orally administered C5aR1 inhibitor for the treat-ment of patients with AAV.

In December 2020, VFMCRP and ChemoCentryx, Inc. announced top-line data from the ACCOLADE clinical study, the largest, randomized, blinded, placebo-con-trolled phase-II trial in the ultra-rare kidney disease C3G to date. Avacopan demonstrat-ed statistically significant improvement in renal function as measured by eGFR com-pared to placebo over 26 weeks of blinded treatment. The change from baseline to week 26 in C3 glomerulopathy histologic index (C3G HI) for disease activity (primary end-point) was not statistically different between the two treatment groups, while the C3G HI for disease chronicity, measuring progression of fibrosis, showed significant benefit for avacopan versus placebo. Avacopan also appeared safe and well-tolerated in patients with C3G. VFMCRP plans to discuss the registration pathway with regulatory agencies in the EU.

N E P H R O L O G Y


Post balance sheet reporting March 2021, Kissei Pharmaceutical Co., Ltd. submitted the Japanese new drug application for the treatment of AAV.

AAV awareness and collaboration VFMRCP is committed to understanding the significant unmet medical need and patient burden of AAV. In 2020, the company contin-ued to work with key stakeholder organiza-tions, including non-governmental patient alliances and national vasculitis patient groups across Europe. The joint company is also supporting a number of activities together with the European Vasculitis Society, research-ers and national vasculitis professional groups which address key topics such as medical education, clinical registry initiatives and investigator-initiated research studies. Additionally, a managed access program continued to be rolled out in 2020, allowing ADVOCATE sites in certain countries to request continued treatment with avacopan for specific AAV patients on the basis of their medical benefit-risk assessment.

VFMCRP advanced its publication activities for AAV in 2020 with numerous scientific presen-tations related to clinical outcomes, burden of disease and related healthcare costs at virtual national and international conferences. Further scientific data was disseminated, with high-profile presentations by investigators at the virtual European ERA-EDTA nephrology

and EULAR rheumatology congresses in June 2020. Additional presentations addressing the disease burden followed in November 2020 at the ASN and ACR.

An online HCP disease education platform – understandaav.com, has been expanded through multiple European languages, attracting more than 50,000 visitors since launch in early 2020. This powerful initiative has highlighted the importance of anticipat-ing new forms of multichannel engagement, especially during the global pandemic.

As a member of the European Organization for Rare Diseases (EURORDIS) Round Table of Pharmaceutical Companies, VFMCRP has engaged in a voluntary, early dialogue-based approach with payers and patient groups through the Mechanism of Coordinated Access to Orphan medicinal Products (MoCa). In 2020, VFMCRP provided support to vasculitis patient advocacy groups through the umbrella organization Vasculitis Interna-tional. Our collaboration with the community has led to the co-creation of the SEE ME | HEAR ME disease awareness initiative created by and for patients and carers. Since its launch on Rare Disease Day in February 2020, the vasculitis community digital platform – myancavasculitis.com, has had more than 30,000 visitors.


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https://www.understandaav.com/

https://www.myancavasculitis.com/

In May 2020, VFMCRP marked the first World Vasculitis Awareness Day together with vasculitis experts and patient representatives, promoting media outreach to raise awareness of the disease management challenges and unmet needs across Europe.

C C X 1 4 0D I S C O N T I N U E D CCX140 is an orally-administered small molecule that is a highly potent and selective inhibitor of the chemokine receptor CCR2. In May 2020, Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc., reported top-line data of the phase-II LUMINA-1 study, which enrolled 46 focal segmental glomerulosclerosis (FSGS) patients with moderate-to-severe protein loss in primary or genetic FSGS.

CCX140 did not demonstrate a meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment. In light of top-line data from the phase-II LUMINA-1 study, CCX140 development in FSGS has been discontinued.

A C U T E K I D N E Y I N J U R Y

A N G - 3 7 7 7I N D E V E L O P M E N T

In November 2020, Vifor Pharma and Angion Biomedica Corp. (Angion) signed a world-wide license agreement, excluding Greater China, for the commercialization of late-stage development product ANG-3777. The product is currently being developed for treatment of delayed graft function (DGF) and cardiac surgery-associated acute kidney injury (CSA-AKI). ANG-3777 is a first-in-class small molecule engineered to mimic the biological activity of hepatocyte growth factor (HGF), activating critical pathways in the body’s natural organ repair process following an acute organ injury.

The agreement further expands Vifor Pharma’s nephrology product pipeline into transplanta-tion and acute kidney injury, leveraging our established infrastructure and significant commercial expertise. ANG-3777 is a highly promising, innovative treatment with a unique mode of action addressing a significant unmet need in DGF and CSA-AKI. There are currently no effective or approved therapies for either of these critical conditions. Under the terms of the agreement, Vifor Pharma will receive an exclusive global license, excluding China, Taiwan, Hong Kong and Macau, for all ANG-3777 nephrology indications. Angion will be responsible for conducting the ongoing nephrology-focused clinical development programs. Angion and Vifor Pharma will share responsibilities for regulatory filings in the licensed territories, and Vifor Pharma will be responsible for all commercialization activities related to nephrology indications in all licensed territo-ries. Addressable patients with DGF is estimated to be about 26,000 and approxi-mately 110,000 with CSA-AKI in the US and EU5 combined each year.

The ongoing clinical trials of ANG-3777 include a placebo-controlled phase-III registration trial in transplant-associated acute kidney injury, also known as DGF, and a phase-II proof-of-concept trial for the treatment of AKI associated with cardiac surgery involving cardiopulmonary bypass surgery. Data read-out for the phase-III trial in DGF is expected at the end of 2021. Data read-out for the phase-II trial in CSA AKI is expected in H2 2021.

N E P H R O L O G Y


C H R O N I C K I D N E Y D I S E A S E A S S O C I A T E D C O M P L I C A T I O N S

D I F E L I K E F A L I NF I L E D I N T H E U S

Difelikefalin, developed by Cara Therapeutics Inc., is a peripherally-restricted kappa opioid receptor agonist which targets the body’s peripheral nervous system. It has been developed as a treatment for chronic kidney disease-associated pruritus (CKD-aP), and has been specifically designed to mitigate side effects typically observed with opiates. Moderate-to-severe CKD-aP is a debilitating systemic itch that impacts up to 40% of dialysis patients around the world.34

CKD-aP is a condition associated with poor quality of life, reduced social interactions and depression. It is also identified as an independent predictor of mortality among hemodialysis patients. There are no approved therapies in Europe or the US for the treat-ment of CKD-aP, with current treatment options (not indicated for the treatment of CKD-aP) linked to limited efficacy and/or unfavorable toler ability.

In April 2020, VFMCRP and Cara Therapeutics announced positive results from the KALM-2 global pivotal phase-III trial, confirming the positive outcome of the KALM-1 study published in 2019. The study showed statisti-cally significant improvement in primary and key secondary endpoints. Difelikefalin was generally well tolerated, with a safety profile consistent with that seen in KALM-1 and in the rest of the clinical program in hemodialysis patients with CKD-aP.

Cara Therapeutics and VFMCRP signed an initial license agreement in May 2018 to develop and commercialize difelikefalin for the treatment of CKD-aP in hemodialysis and peritoneal dialysis patients worldwide, excluding the US, Japan and South Korea. In

34 Rayner HC, et al. Clin J Am Soc Nephrol 2017;12:2000–7.

the US, Cara Therapeutics and VFMCRP agreed to promote difelikefalin to Fresenius Medical Care North America (FMCNA) dialysis clinics under a profit-sharing arrangement.

In October 2020, Vifor Pharma and Cara Therapeutics signed a license agreement for the commercialization of difelikefalin injection for the treatment of CKD-aP in the US dialysis market for non-Fresenius Medical Care clinics under a profit-sharing arrangement. Under the terms of the agreement, Cara will receive an upfront milestone payment and an equity investment from Vifor Pharma, which now has an 8.3% stake in the company. Commercializa-tion rights for difelikefalin in the full dialysis segment will enable Vifor Pharma to expand its nephrology presence in the US, with non-FMC dialysis clinics representing approxi-mately 66% of the total market. The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection.

Cara Therapeutics submitted the New Drug Application (NDA) in the US for difelikefalin for the treatment of moderate-to-severe CKD-aP in December 2020. Subject to approval, US launch is expected in H2 2021. VFMCRP is planning to submit its initial MAA in Europe in early 2021, followed by applications in Canada, Switzerland and Australia in H2 2021 through consortium filing. Approval in Europe is expected in Q2 2022, followed by first European launches in mid-H2 2022. Subject to approvals, difelikefalin would be the first medicine indicated for the treatment of CKD-aP in the US and Europe.

Market preparations were undertaken during 2020, with a focus on disease education and stakeholder engagement to ensure aware-ness of the unmet need, burden of disease and the value of difelikefalin for dialysis patients with CKD-aP. Based on the principles of value- based medicine, VFMCRP is now investigating how the quality of life of dialysis patients with CKD-aP can be improved, including diagnosis, treatment and evaluation of outcome measures.


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C A R D I O - R E N A LO U R P O R T F O L I O

V E LT A S S A®

Veltassa® (patiromer), is the first product to offer effective35 and well-tolerated36 long-term treatment of hyperkalemia (elevated blood potassium levels) in chronic kidney disease (CKD) and chronic heart failure patients.

Hyperkalemia is a serious medical condition characterized by elevated levels of potassium in the blood and can be associated with life-threatening consequences. Patients with CKD and heart failure, especially those treated with RAAS (renin-angiotensin-aldosterone system) inhibitors are at particular risk of developing hyperkalemia. As a consequence, RAASi therapy, the cornerstone of treatment for CKD and heart failure, is often reduced or discontinued, compromising cardio-renal protection. Veltassa® enables patients to remain on RAASi therapy by effectively managing their chronic hyperkalemia.

In 2020, Vifor Pharma continued to create awareness of the unmet medical need for the treatment of patients with hyperkalemia and the new option to chronically manage hyperkalemia, permitting patients to stay on an optimal dose of their life-saving RAASi medications. Growth is expected to be driven by further clinical data from ongoing life cycle management activities and disease awareness initiatives.

R E P O R T E D N E T S A L E S

Net sales of Veltassa® decreased by –10.6% to CHF 118.3 million in 2020 from CHF 132.3 million in 2019, –5.1% at constant exchange rates.

35 Agarwal R, et al. Lancet 2019;394:1540–50.36 Veltassa® EU SmPC 2019

Veltassa® has experienced steady and sustained growth since FDA approval alaunch in 2015, helping to drive the global expansion of the potassium binder market from CHF 185.6 million in 2016 to CHF 431.0 million in 2020. Overall, the market has not grown to expectations, which in 2020 is in part due to the impact of the global COVID-19 pandemic, and market access headwinds in the US. Vifor Pharma continues to be a market share leader among nephrologists and cardiologists.

Vifor Pharma continues to create disease awareness to accelerate market growth, establish positive clinical differentiation and improve up-take of prescriptions. Through ongoing clinical studies, we hope to demon-strate strong outcome data with the opportu-nity to accelerate growth and further improve product distinction to establish acceptance for RAASi enabling concept.

L I F E C Y C L E M A N A G E M E N T A N D I N V E S T I N G I N T H E F U T U R E O F V E LT A S S A®

Vifor Pharma is committed to investing in data generation programs to drive evidence-based care using Veltassa® in chronic kidney disease (CKD) and heart failure (HF) patients. After the positive results of the phase-II AMBER study in resistant hypertension and CKD, Vifor Pharma undertook a major investment in the DIAMOND phase-IIIb study. This reflects the company’s belief in the potential of Veltassa® in treating hyperkalemia and enabling life-saving medications in CKD and heart failure patients. DIAMOND is an out-come-driven study in patients with chronic heart failure, designed to support the further use of Veltassa® by effectively controlling blood potassium levels, and evaluating


whether this will lead to optimized RAASi therapy, thereby improving survival and reducing hospitalization.

The study is a global, multicenter, double- blind, placebo-controlled trial aiming to enroll approximately 2,400 patients in over 400 sites. DIAMOND will include patients with heart failure (with or without CKD) and either current hyperkalemia at screening, or a history of hyperkalemia in the past year, leading to a reduction or discontinuation of RAASi therapy. The primary endpoint of the study is the time to first occurrence of cardiovascular death or cardiovascular hospitalization. In the first half of 2020, Vifor Pharma temporarily halted enrolment of new patients, and in agreement with the study steering committee, to minimize risk of COVID-19 to the patients in the study. In June 2020, recruitment was re-ini-tiated. By the end of the year, the majority of participating countries had opened planned trial sites, or re-opened the temporarily halted sites. Several initiatives to facilitate the safe recruitment of patients to the trial have been implemented. All study patients are expected to be enrolled in the trial by the end of 2021,

however the impact of the pandemic on recruitment and trial operations worldwide remains uncertain. Vifor Pharma’s first priority remains the safety and well-being of the patients in the trial.

PLATINUM is a randomized, double-blinded, placebo-controlled phase-IV study with 300 patients enrolled. The study is designed to evaluate the efficacy and safety of Veltassa® in combination with standard of care treat-ment in emergency department (ED) patients with hyperkalemia. The key primary endpoint evaluates the need of additional potassium- related medical interventions at six hours after initial treatment with insulin, glucose and albuterol to shift potassium to the cells. Given the lack of consistency in hyperkalemia treatment in the ED and the high cost associat-ed with ED stay and emergency hemodialysis, there is a need for the development and systematic evaluation of a treatment protocol to maintain normalized potassium levels after emergency treatment, by the removal of potassium from the body with a potassium binder. Topline results are expected in H1 2022.


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In November 2020, the EMA approved two significant additions to the SmPC for Veltassa®. This included results of the phase-II AMBER study, providing novel evidence on Veltassa® RAASi enabling in a relevant population of patients with resistant hypertension and CKD. AMBER results showed that administration of Veltassa® significantly increased the propor-tion of patients who remained on spironolac-tone and reduced the risk for hyperkalemia during spironolactone therapy. The precau-tions for storage were also clarified, allowing the room temperature storage period to also be applied to settings such as hospitals, where product is not stored by patients themselves. This provides increased convenience for HCPs, limiting the competitive disadvantage of refrigerated storage requirements.

Due to the sophisticated structure of patiromer complex active pharmaceutical ingredient and its complex route of delivery as a locally acting gastro intestinal drug, Veltassa® belongs to the FDA’s Harder-to-Copy Complex Products category and is considered a Non-Biologic Complex Drug (NBCD). These are in contrast to small molecules drugs were the physico- chemical structure cannot be fully character-ized and are best defined by their pro prietary manufacturing process.

G L O B A L E X P A N S I O N , R E I M B U R S E M E N T A N D R E G U L A T O R Y A P P R O V A L S

In January 2020, Veltassa® received reim-bursement approval in Finland, followed by Portugal and Switzerland. Our partner, Otsuka Canada Pharmaceutical Inc., launched Veltassa® in Canada in May 2020. Formulary access in England, Wales and Northern Ireland was fully achieved as a result of the National Institute for Health and Care Excellence (NICE) technology appraisal guidance in February 2020.

In Japan, Vifor Pharma has a licensed Veltassa® to Zeria Pharmaceutical Co., Ltd., granting Zeria exclusive rights to develop the necessary clinical data to support Veltassa®’s regulatory and reimbursement approval. In line with Vifor Pharma’s commitment to make Veltassa® available to patients worldwide, a phase-II trial was initiated in Japan in 2019 and completed enrolment during the first half of 2020. The study remains on track with read-out expected in H1 2021.

In November 2020, Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Fresenius Kabi announced an agreement to develop, register and distribute Veltassa® for the treatment of hyperkalemia in the People’s Republic of China. Under the agreement, Fresenius Kabi will have the exclusive right to distribute and sell Veltassa® across China. By bringing Veltassa® to China, VFMCRP and Fresenius Kabi will deliver a treatment that will enable patients to remain on RAASi therapy by managing their chronic hyperkalemia. A local phase-III study in China is planned to start in Q3 2021, with expected read-out in H1 2024. Following positive trial results, a

REIMBURSEMENT APPROVAL IN FINLAND, PORTUGAL AND SWITZERLAND

GLOBAL EXPANSION

VFMCRP AND FRESENIUS KABI PARTNERSHIP BRINGS VELTASSA® TO CHINA

C A R D I O - R E N A L


New Drug Application (NDA) would be filed for regulatory approval in mid-2024.

Fresenius Kabi is a global healthcare company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. Veltassa® will benefit from Fresenius Kabi’s market-leading nephrology patient access in China alongside Velphoro® and Venofer®. There is a high prevalence of CKD and heart failure in China37 and hyperkalemia is one of the most common complications associated with these two conditions. As a result there is a high demand for an effective, proven hyperkalemia treatment.

37 Zhang et al. Lancet. 2012 Mar 3;379(9818):815-22; Guo et al. Int J Environ Res Public Health 2016; 13: E770; Guo et al. Curr Cardiol Rev. 2013 May; 9(2): 112–122.

O T H E R D I S E A S E A W A R E N E S S I N I T I A T I V E S

In line with our commitment to expand awareness, Vifor Pharma is proud to support people living with hyperkalemia and to partner with the American Association of Kidney Patients (AAKP), the largest and oldest fully independent kidney patient organization in the US. In May 2020, AAKP initiated a national educational “Are You O-K+” campaign aimed at increasing awareness of hyper-kalemia. This national campaign, supported by Vifor Pharma as an inaugural sponsor, is also known as National High Potassium Awareness Day.


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O T H E R I R O N T H E R A P I E S

V I T- 2 7 6 3 I N D E V E L O P M E N T

Beta-thalassemia is an inherited rare blood disorder that reduces the production of functional haemoglobin in red blood cells, which can lead to a lack of oxygen in many parts of the body and potentially cause anemia. Beta-thalassemia is often treated with blood transfusions, which may lead to excess levels of iron in the body, known as iron overload. The condition is estimated to affect around 25,000 patients in both the US and Europe. In June 2019, both the FDA and the EMA granted orphan drug designations for VIT-2763 in beta-thalassemia.

Following positive phase-I study results, Vifor Pharma initiated a phase-II trial in non-trans-fusion-dependent beta-thalassemia (NTDT) with the first patient first visit in Q2 2020. The main objective of this randomized, controlled, multinational trial is to investigate the safety, tolerability and efficacy of VIT-2763 in NTDT patients.

In addition, VIT-2763 has shown promising results in a preclinical model of sickle cell disease (SCD), a condition where formation of aberrant haemoglobin causes a variety of complications, including painful vaso-occlu-sive crisis and organ damage.

SCD is a group of inherited red blood cell disorders, and is a genetic condition present at birth. In this disease, red blood cells carry abnormal haemoglobin, which makes them prone to rupture, causing adhesion of sickle cells and inflammatory cells to the blood vessels. This ultimately leads to an obstruction of blood flow and organ damage. VIT-2763 blocks the ferroportin protein, which transports iron from inside the cells into the blood-stream. As iron is needed for the formation of haemoglobin, this relative decrease in iron availability is expected to reduce the concen-tration of abnormal haemoglobin in red blood cells and prevent ensuing unfavorable events. Ferroportin inhibition is expected to allow better blood flow and to improve both the symptoms and clinical outcomes of the disease. There are an estimated 150,000 patients in both Europe and the US living with the condition. Post balance sheet reporting January 2021, the FDA granted orphan drug designation for VIT-2763 in SCD, and the EMA issued a positive opinion on an orphan designation for the same.

Activities for a phase-II trial in SCD have been initiated, with the aim to start recruitment in 2021.

Vifor Pharma is using its expertise in understanding the chemistry and biology of iron to develop VIT-2763, the first oral ferroportin inhibitor with the potential to treat diseases with ineffective erythropoiesis and iron overload, such as beta-thalassemia.

O U R P O R T F O L I O


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in million CHF 20202019

Restated*

Net sales 1,705.6 1,725.0

Other income 96.4 37.0

Cost of sales (701.2) (700.8)

Gross profit 1,100.8 1,061.2

Marketing and distribution (403.8) (435.7)

Research and development (250.0) (212.0)

General and administration (155.7) (137.6)

Operating profit (EBIT) 291.4 275.9

› Financial income 17.5 11.8

› Financial expenses (40.2) (26.9)

Net financial result (22.7) (15.0)

Share of net result from joint venture (4.0) -

Profit before income taxes (EBT) 264.7 260.9

Income taxes (27.1) (38.1)

Profit from continuing operations 237.6 222.8

Profit from discontinued operations 220.9 50.9

Net profit 458.6 273.8

Attributable to:

› Shareholders of Vifor Pharma Ltd. 359.6 159.1

› Non-controlling interests 98.9 114.7

Earnings per share in CHF

Basic earnings per share 5.54 2.45

Diluted earnings per share 5.53 2.45

Earnings per share from continuing operations in CHF

Basic earnings per share 2.14 1.67

Diluted earnings per share 2.13 1.66

C O N S O L I D A T E D S T A T E M E N T O F I N C O M E



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TSC O N S O L I D A T E D S T A T E M E N T

O F F I N A N C I A L P O S I T I O N

in million CHF2020

31.12.2019

31.12.

Cash and cash equivalents 730.0 544.9

Financial assets 8.3 0.3

Trade and other receivables 487.7 471.9

Income tax receivables 4.7 7.2

Inventories 339.8 348.6

Prepaid expenses and accrued income 38.4 34.2

Current assets 1,609.0 1,407.1

Property, plant and equipment 240.8 282.4

Right-of-use assets 62.0 68.6

Intangible assets 2,454.5 2,584.5

Investment in joint venture 23.1 -

Financial assets 717.4 510.3

Deferred tax assets 65.7 39.7

Employee benefit assets 39.2 41.7

Non-current assets 3,602.7 3,527.3

Assets 5,211.7 4,934.4

Financial liabilities 8.9 0.9

Lease liabilities 14.1 16.8

Trade and other payables 162.1 107.9

Income tax payables 102.5 89.3

Accrued expenses and deferred income 249.1 321.4

Provisions 7.3 4.9

Current liabilities 544.0 541.3

Financial liabilities 552.8 566.6

Lease liabilities 55.8 59.9

Deferred tax liabilities 30.7 20.4

Employee benefit liabilities 10.4 10.5

Provisions 0.4 0.4

Non-current liabilities 650.1 657.8

Share capital 0.7 0.7

Reserves 3,569.2 3,316.9

Equity attributable to shareholders of Vifor Pharma Ltd. 3,569.8 3,317.6

Non-controlling interests 447.8 417.8

Shareholders' equity 4,017.6 3,735.3

Liabilities and shareholders' equity 5,211.7 4,934.4


C O N S O L I D A T E D S T A T E M E N T O F C A S H F L O W S

in million CHF 20202019

Restated*

Profit from continuing operations 237.6 222.8

Income taxes 27.1 38.1

Depreciation, amortization and impairment 284.4 209.1

Change in provisions and employee benefit assets and liabilities 7.2 (22.3)

Net financial result 22.7 15.0

Other non-cash items (5.8) 22.1

Change in trade and other receivables (84.9) 40.1

Change in inventories (20.9) (70.3)

Change in trade and other payables 39.4 (34.1)

Change in other net current assets (60.8) 83.4

Interest received 2.2 4.0

Interest paid (5.9) (7.0)

Income tax paid (39.6) (28.1)

Cash flow from discontinued operations 21.2 52.1

Cash flow from operating activities 423.8 524.8

Investments in property, plant and equipment (68.5) (40.3)

Investments in intangible assets (316.1) (88.2)

Investments in joint venture and subsidiaries (10.4) (0.2)

Investments in financial assets and securities (43.4) (3.7)

Proceeds from property, plant and equipment 4.2 0.7

Proceeds from intangible assets 31.0 2.2

Proceeds from financial assets and securities 82.9 4.3

Net proceeds from disposal of OM Pharma (discontinued operations) 378.4 -

Cash flow from discontinued operations (5.8) (7.4)

Cash flow from investing activities 52.4 (132.5)

Dividends paid (219.6) (174.7)

Purchase of treasury shares (28.9) (11.7)

Sale of treasury shares 4.0 2.5

Proceeds from financial liabilities - 0.5

Repayment of financial liabilities (0.9) (37.0)

Payment of lease liabilities (22.7) (18.0)

Cash flow from discontinued operations (0.1) (0.1)

Cash flow from financing activities (268.4) (238.5)

Effects of exchange rate changes on cash and cash equivalents (22.7) (9.3)

Increase in cash and cash equivalents 185.1 144.6

Cash and cash equivalents as at 1 January 544.9 400.3

Cash and cash equivalents as at 31 December 730.0 544.9



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Market access The approval of Ferinject® in China is expected in the second half of 2021. Launch of difelikefalin (KORSUVATM) is expect-ed in the US, upon approval in the second half of 2021. VFMCRP plans to submit its marketing authorization application in Europe in the first half of 2021. The European Medicines Agency (EMA) approval for avacopan in Europe is expected in the second half of 2021. If approved, it will be the first orally administered C5aR1 inhibi-tor for the treatment of patients with AAV. Our partner Akebia plans to submit a New Drug Application to the FDA for vadadustat by mid-Q2 2021, for the treatment of anemia due to CKD for adult patients on dialysis, and not on dialysis.

Clinical trials Vifor Pharma expects to complete recruitment in a phase-II trial of VIT-2763 in non-transfusion- dependent beta-thalassemia in the second half of 2021. Additionally, a phase-II trial in sickle cell disease will be initiated in H1 2021. A phase-II proof-of-concept trial of ANG-3777 for the treatment of cardiac surgery-associated acute kidney injury is underway, with data read-out expected in H2 2021. Clinical readout of a phase-III trial of ANG-3777 in delayed graft function (DGF) is expected at the end of 2021.

Business development

In line with our ambition to strengthen our product pipeline, we aim to complete at least two in-licensing deals, product acquisitions or corporate transactions in 2021.

F I N A N C I A L G U I D A N C E

In 2021, at constant exchange rates net sales are expected to grow at a low-to-mid single digit rate and EBITDA to grow at a high single digit rate.1

1 The COVID-19 pandemic continues to impact economic conditions and patient access to our treatments; therefore Vifor Pharma’s outlook assumes a progressive improvement of patients' access to the Company’s treatments as of H2 2021

O U T L O O K : C O N T I N U E D G R O W T H I N N E T S A L E S A N D E B I T D A

2 0 2 1 O U T L O O K A N D F I N A N C I A L G U I D A N C E

S T E F A N S C H U L Z E

CHIEF EXECUTIVE OFFICER

We strive to make a real difference in people’s lives. As the Executive Committee, this is our driving force and our motivation to do what we do.”

C O R P O R A T E C O V E R N A N C E

M E M B E R S O F T H E E X E C U T I V E C O M M I T T E E

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50 Vifor Pharma Ltd. Annual Report 202050

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S T E F A N S C H U L Z ECHIEF EXECUTIVE OFFICER

B A R B A R A A N G E H R N CHIEF BUSINESS OFFICER

C O L I N B O N D CHIEF FINANCIAL OFFICER

L E E H E E S O NPRESIDENT INTERNATIONAL

D R . K L A U S H E N N I N G J E N S E N CHIEF MEDICAL OFFICER

M I C H A E L P U R ICHIEF HR OFFICER

D R . C H R I S T O P H S P R I N G E RCHIEF STRATEGY OFFICER

G R E G O R Y O A K E S PRESIDENT NORTH AMERICA

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C O R P O R A T E C O V E R N A N C E

M E M B E R S O F T H E B O A R D O F D I R E C T O R S

J A C Q U E S T H E U R I L L A T

CHAIRMAN OF THE BOARD

OF DIRECTORS

We are committed to ensuring Vifor Pharma’s success story continues, bringing innovative treatments to market and expanding strong partnerships to address underserved therapeutic areas.”

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Vifor Pharma Ltd. Annual Report 202052 Vifor Pharma Ltd. Annual Report 2020

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J A C Q U E S T H E U R I L L A TELECTED IN 2018

G I L B E R T A C H E R M A N NELECTED IN 2020

P R O F. H O N . D R . M I C H E L B U R N I E R ELECTED IN 2010

D R . R O M E O C E R U T T I ELECTED IN 2015

D R . S U E M A H O N YELECTED IN 2019

K I M S T R A T T O N ELECTED IN 2019

D R . G I A N N I Z A M P I E R I ELECTED IN 2017

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G R O U P S T R U C T U R EA N D S H A R E H O L D E R S

C O R P O R A T E G O V E R N A N C E

S T R U C T U R E O F T H E G R O U P

Vifor Pharma Ltd., headquartered at Rechen-strasse 37, 9014 St. Gallen, Switzerland, is a corporation under Swiss law. As a holding company, Vifor Pharma Ltd. owns all the companies in Vifor Pharma Group directly or indirectly. Vifor Pharma Group consists of Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma, the joint company with Fresenius Medical Care. The Group’s structure and the consolidated subsidiaries and associates are shown in the financial state-ments 2020 on pages 202 to 203. Articles of Association, Organizational Regulations and charters of the Committees of the Board of Directors can be accessed at viforpharma.com/governance. Vifor Pharma Ltd.’s shares are listed on SIX Swiss Exchange; shares of the individual Group companies are not publicly traded.

S H A R E H O L D E R S

As of 31 December 2020, Vifor Pharma had 18,738 shareholders registered in the share register, six of which according to documents submitted to Vifor Pharma Ltd. and the SIX Swiss Exchange were major shareholders holding more than 3% of the voting rights in Vifor Pharma Ltd. at the respective latest notification date:

– Patinex AG, Freienbach, Switzerland, and BZ Bank Aktiengesellschaft, Freienbach, Switzerland (beneficial owners: Martin and Rosmarie Ebner, Wilen, Switzerland), with 13,250,000 registered shares.

– BNP PARIBAS SA, Paris, France, with 5,143,408 registered shares.

– Priora Suissa AG, Freienbach, Switzerland, and Priora Investment Ltd., Dubai, UAE (beneficial owners: Remo and Manuela Stoffel, Dubai, UAE), with 4,613,000 registered shares.

– Alecta pensionsförsäkring, ömsesidigt, Stockholm, Sweden, with 2,100,000 registered shares.

– UBS Fund Management (Switzerland) AG, Basel, Switzerland, with 1,986,015 regis-tered shares.

– BlackRock, Inc., New York, USA, with 1,824,186 own registered shares, and additional 1,233,758 voting rights as delegate for a third party.

No other shareholder has announced a crossing of the 3% threshold of voting rights. The transactions disclosed to the stock exchange Disclosure Office pursuant to Art. 120 et seq. of the Financial Markets Infrastructure Act (FinfraG) is available on the Disclosure Office website of the SIX Swiss Exchange: https://www.ser-ag.com/de/resources/notifications-market-participants/significant-shareholders.html#/

C R O S S S H A R E H O L D I N G S

Vifor Pharma Ltd. has no cross shareholdings in companies outside the Vifor Pharma Group.

E V E N T S A F T E R T H E B A L A N C E S H E E T D A T E

There are no changes to report.


https://www.viforpharma.com/en-gb/investors/corporate-governance

https://www.ser-ag.com/de/resources/notifications-market-participants/significant-shareholders.html#/

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Chairman

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Annual General Meeting of Vifor Pharma Ltd.

V I F O R P H A R M A G R O U P G O V E R N A N C E 1

1 As of 1 January 2020 2 Appointed as of 1 January 2020 3 Appointed as of 2 February 2020

Governance, Nomination and Sustainability Committee

Remuneration Committee

Audit and Risk Committee

Scientific Committee US Committee

Chief Financial Officer

President North America

President International3

Chief Human Resources Officer

Chief Strategy Officer

Chief Business Officer

Governance Ethics Compliance Data Privacy

Chief Medical Officer2


S T R U C T U R E O F T H E S H A R E C A P I T A L

C O R P O R A T E G O V E R N A N C E

S H A R E C A P I T A L

Vifor Pharma shares (securities no. 36474934, ticker symbol VIFN) are listed on the SIX Swiss Exchange. As of 31 December 2020, 64,855,162 registered shares were outstand-ing (not including treasury shares). The market capitalization amounted to CHF 9,035,000,000.

A U T H O R I S E D C A P I T A L

According to Art. 3a of the Articles of Associa-tion, the Board of Directors is authorized to increase the share capital of CHF 650,000 by a maximum of CHF 65,000 at any time up to and including 14 May 2022 by issuing no more than 6,500,000 fully paid registered shares, with a par value of CHF 0.01 each.

Should the Board of Directors decide to exercise its authority to increase the share capital, all existing shareholders would be entitled to exercise subscription rights corresponding to their then current share-holdings. The Board of Directors may only decide to restrict or deny the subscriptions rights of shareholders and to allocate them to third parties if the new shares are to be used for the purposes set forth in Art. 3a para. 3 lit. a) to c) of the Articles of Association.

C O N D I T I O N A L C A P I T A L

Vifor Pharma has no conditional capital.

C H A N G E S I N T H E C A P I T A L I N R E C E N T Y E A R S

Information about changes in the share capital, reserves and distributable profit over the past few years can be found on page 171 of the financial statements 2020. Please see previous annual reports for information about prior years.

P A R T I C I P A T I O N C E R T I F I C A T E S

Vifor Pharma has no participation certificates.

D I V I D E N D C E R T I F I C A T E S

Vifor Pharma has no dividend certificates.

R E G I S T R A T I O N A N D V O T I N G R I G H T S

Pursuant to Art. 6 of the Articles of Associa-tion, each registered share entitles the holder to one vote at the Annual General Meeting. The Board of Directors may refuse registration of voting rights in the shareholders’ register if purchasers do not declare explicitly, upon request, that they have acquired the shares in their own name and for their own account.

The Board of Directors is also authorized, after hearing the individuals concerned, to cancel any entries with voting rights in the sharehold-ers’ register that were obtained on the basis of incorrect information.

On 31 December 2020, the fully paid share capital of Vifor Pharma Ltd. amounted to CHF 650,000, divided into 65,000,000 publicly listed registered shares with a nominal value of CHF 0.01 each.


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A N N U A L G E N E R A L M E E T I N G

Registration of nomineesA nominee may apply for registration with voting rights up to a limit of 2% of the share capital entered in the commercial register without disclosing the name, address and the number of shares of the person for whose account the nominee holds 0.5% or more of the share capital as set forth in the commercial register.

Shares in excess of this limit can only be registered if the nominee in question dis closes the name, address and number of shares of the person for whose account the nominee holds 0.5% or more of the share capital entered in the commercial register. During the financial year 2020, agreements of this nature were in force with four nominees.

Legal entities and partnerships, other groups of persons or joint owners who are interre-lated through capital ownership, voting rights, common management or are otherwise linked, as well as individuals or legal entities or partnerships that act in concert to circumvent this provision, shall be treated as one single entity.

C O N V E R T I B L E B O N D S A N D O P T I O N S

Vifor Pharma has no outstanding convertible bonds, nor has it issued any traded options.



V I F O R P H A R M A

U P C O M I N G D A T E S

K E Y C O R P O R A T E D A T E S I N 2 0 2 1 3 March 2021 Annual Report 2020 Analyst conference: full-year results 2020 — 6 May 2021 Annual General Meeting— 5 August 2021 Half-year Report 2021


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ImprintVifor Pharma Group

This report is available to download at viforpharma.com

In the case of any discrepancy in the interpretation of the short version of the English, French or German texts of this report, the English text of the full version shall be authoritative.

March 2021 © Vifor Pharma Ltd.

Legal disclaimerNo part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without previous written approval by the Vifor Pharma Group. All Vifor Pharma Group’s intellectual rights, including copyright, are reserved by the Vifor Pharma Group.

All other trademarks are the property of their respective owners.

Vifor Pharma Ltd.Rechenstrasse 379014 St. GallenSwitzerland Vifor Pharma GroupVifor Pharma Management Ltd. Flughofstrasse 61 8152 GlattbruggSwitzerland

Phone +41 58 851 80 00Mail [email protected]

MEDIA CONTACT [email protected]

INVESTOR CONTACT [email protected]

viforpharma.com

C O N T A C T I N F O R M A T I O N

https://www.viforpharma.com/


Vifor Pharma GroupVifor Pharma Management Ltd. Flughofstrasse 618152 GlattbruggSwitzerland

Phone +41 58 851 80 00 Mail [email protected] Web viforpharma.com


annual report 2020 at a glance - vifor pharma

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