HALF-YEAR REPORT 2019 - Vifor Pharma
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VIFOR
PHARMA
HALF-YEAR
REPORT
2019
Half Year Report 2019_English_1 1 05.08.2019 13:10:48
PATIENTS AT OUR CORE
About Andy
Andy is a chef based in London with his wife
Sarah and son Noah. He has lived with
iron deficiency since being diagnosed at
the age of 16.
Despite living with iron deficiency and Crohn’s
disease, he leads an active life and has
a passion for food. He successfully competes at
international cooking competitions.
Andy recognises the signs and symptoms of iron
deficiency and is able to proactively manage
his iron levels with his physician, and the support
of his wife. Today, Andy enjoys life without
restrictions.
Half Year Report 2019_English_1 2 05.08.2019 13:10:51
TABLE OF CONTENTS
04 Letter to shareholders 27 2019 Outlook and financial guidance
06 Highlights
09 Vision, mission and strategy 28 Consolidated interim financial statements
10 Performance overview 30 Consolidated statement of income
31 Consolidated statement of
12 Our products comprehensive income
Key growth drivers 32 Consolidated statement of financial position
14 Ferinject®/Injectafer® 33 Consolidated statement of changes in equity
18 Vifor Fresenius Medical Care Renal Pharma 34 Consolidated statement of cash flows
18 RENAL ANAEMIA MANAGEMENT 35 Notes to the consolidated financial statements
18 – Erythropoiesis-Stimulating Agents (ESAs)
18 – Mircera® 42 Upcoming dates
18 – Retacrit™ 43 Contact information
18 – Venofer®
19 – Vadadustat
19 MINERAL AND BONE MANAGEMENT
19 – Velphoro®
19 – Rayaldee®
20 KIDNEY FUNCTION PRESERVATION
20 – Avacopan
20 – CCX140
20 CONDITIONS ASSOCIATED WITH KIDNEY
IMPAIRMENT AND ITS TREATMENT
20 – CR845
22 Veltassa®
24 Other products
24 – Maltofer®
24 – VIT-2763
25 O M PHARMA
25 – Broncho-Vaxom®
25 – Uro-Vaxom®
25 – Doxium®
Vifor Pharma Ltd. Half-year Report 2019 3
Half Year Report 2019_English_1 3 05.08.2019 13:10:51
LETTER TO SHAREHOLDERS
Etienne Jornod Stefan Schulze
DEAR SHAREHOLDER,
Vifor Pharma Group achieved a strong financial 25% and 30%. The progress achieved in the first
and operating performance in the first half of half of 2019 also makes us confident to achieve
2019, building on the outstanding progress made our Milestone 2020 targets of more than CHF 2
in 2018. Through sustained focus on the execu- billion net sales and EBITDA in the range of
tion of our three strategic growth drivers, we are CHF 700 million.
on track to deliver our ambitious financial and
business goals, and to realise our vision of Each of our three growth drivers, Ferinject®/
becoming global leader in iron deficiency, Injectafer®, the joint company Vifor Fresenius
nephrology and cardio-renal therapies. Medical Care Renal Pharma, and Veltassa®
delivered a strong performance in H1 2019.
It is now more than two years since we created
Vifor Pharma as a stand-alone company. We are
very happy to report that the positive momen- FERINJECT®/INJECTAFER®
tum continued into 2019 and we are well posi-
tioned to achieve our objectives for both the full Ferinject®/Injectafer® expanded its position as
year 2019 and Milestone 2020. Furthermore the global leader in intravenous (i.v.) iron in value,
we are increasingly focused on the goals of with strong growth particularly in the areas of
Objective 2025. gastroenterology in the US, and in chronic heart
failure and patient blood management in Europe.
During the first half of 2019, Vifor Pharma Group By June 2019, the product was approved in 81
further expanded its global leadership position countries, with more than 10 million years of
in iron deficiency and continued to move patient experience. We continue to expect full
towards leadership in nephrology and cardio- year reported growth of approximately 20% and
renal therapies. Total net sales increased by in-market sales for Ferinject®/Injectafer® of
22.2% to CHF 913.3 million, compared to prior more than CHF 1 billion for the full year 2019.
year, and reported EBITDA was up 32.6%
at CHF 254.6 million compared to CHF 192.0
million in H1 2018. VIFOR FRESENIUS MEDICAL CARE RENAL
PHARMA (VFMCRP)
We have raised our full year guidance for 2019
with net sales expected to exceed 15% and The partnership with Fresenius Medical Care
reported EBITDA expected to grow between through the joint company VFMCRP is the basis
4 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 4 05.08.2019 13:10:57
of our ambition to become the global leader imbursement negotiations and launches will
in nephrology. The VFMCRP portfolio continued continue in line with individual reimbursement
to grow in the first six months of 2019, due in timelines across Europe throughout 2019 and
particular to the recent outstanding success of 2020. Veltassa® is on track to achieve growth in
Velphoro® in the US. 2019 of approximately 50%.
Mircera® also continued to perform strongly, We are investing in studies that demonstrate
exceeding all expectations, primarily due to Veltassa®’s benefits to both patients and clini-
the conversion of existing long-acting erythro- cians. Positive results from the phase-II AMBER
poiesis-stimulating agent (ESA) patients within study were announced in May 2019, demonstrat-
mid-sized and independent dialysis organisations ing Veltassa®’s potential to help patients with
in the US. resistant hypertension and CKD to maintain
optimal treatment. The DIAMOND study, evaluat-
Venofer® maintained its position as the world’s ing the potential of Veltassa® in combination with
leading i.v. iron brand in volume terms, with more renin-angiotensin-aldosterone system inhibitors
than 25 million patient years of experience. (RAASi) medications to improve patient out-
The publication of the PIVOTAL study results in comes, enrolled its first patient in May 2019.
Q4 2018 helped to confirm the tolerability of
Venofer® as a key differentiator, one of the main
reasons the brand retains strong demand after FERROPORTIN
many decades on the market.
Vifor Pharma also made important progress with
In April, we further expanded our partnership its own in-house developed product. In January,
with Akebia in the US for vadadustat, creating we reported positive phase-I results from VIT-2763,
an opportunity for it to be provided to up to 60% an oral ferroportin inhibitor, which aims to
of US dialysis patients, subject to FDA approval. treat diseases related to iron overload. This has
provided a strong basis for a phase-II study
Velphoro® grew significantly in the US in the first planned to begin in the second half of 2019.
half of 2019. This growth was driven by the update
of the KDIGO (Kidney Disease Improving Global
Outcomes) guidelines in 2017, to recommend the ORGANISATION
use of non-calcium-based phosphate binders.
The Board of Directors was further strengthened
In May, our partner Cara Therapeutics, Inc. in May by the election of Dr Sue Mahony and
announced positive results from the first US Kim Stratton to the Board of Directors. We would
phase-III trial of CR845 in haemodialysis patients like to express our gratitude to Daniela Boss-
with moderate-to-severe pruritus associated with hardt-Hengartner, Dr Sylvie Grégoire and Fritz
chronic kidney disease (CKD). The results showed Hirsbrunner who stepped down after many
statistically significant improvements in both the years of distinguished service.
primary and secondary endpoints, with top-line
results from a second global phase-III trial Our success in the first half of 2019 was made
expected in H2 2019. possible due to the support of our shareholders
and dedicated, talented employees across
Vifor Pharma Group, who continue to deliver our
VELTASSA® company mission – helping patients around
the world with severe and chronic diseases, lead
Veltassa®, our third strategic growth driver, better, healthier lives.
continued to transform the treatment of patients
with hyperkalaemia in the first half of the year. By Yours sincerely,
the end of June, Veltassa® had been prescribed
to over 100,000 patients since launch in the US,
and is among the fastest growing nephrology
drugs in the last ten years.
In May 2019, the Act on the Reform of the Market Etienne Jornod Stefan Schulze
for Medicinal Products (AMNOG) process Executive Chairman of President of the
for Veltassa® in Germany was completed, with the Board of Directors Executive Committee
Veltassa® now fully reimbursed. Further re- and COO
Vifor Pharma Ltd. Half-year Report 2019 5
Half Year Report 2019_English_1 5 05.08.2019 13:10:57
HIGHLIGHTS
NET SALES
913.3
MILLION
CHF
+22.2%
EBITDA
254.6
MILLION
CHF
+32.6%
CORE EARNINGS¹ CASH FLOW FROM
PER SHARE OPERATING ACTIVITIES EQUITY RATIO
2.11 197.9 74.0%
MILLION
CHF
CHF
–20.7% +159.6 million CHF –0.8 p.p.
1 Core earnings are defined as reported earnings
after minorities adjusted for proportionate
amortisation of intangible assets.
6 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 6 05.08.2019 13:10:57
TOTAL FERINJECT®/
INJECTAFER® NET SALES
273.4
MILLION
CHF
+19.4%
MIRCERA® NET SALES
276.2
MILLION
CHF
+29.0%
VELTASSA® NET SALES
62.6
MILLION
CHF
+69.9%
Vifor Pharma Ltd. Half-year Report 2019 7
Half Year Report 2019_English_1 7 05.08.2019 13:10:578 Vifor Pharma Ltd. Half-year Report 2019 Half Year Report 2019_English_1 8 05.08.2019 13:10:58
VISION, MISSION AND STRATEGY
Our vision
To be global leader in iron deficiency, nephrology and
cardio-renal therapies. The partner of choice for specialty
pharmaceuticals and innovative, patient-focused solutions.
Our mission
We strive to help patients around the world with severe
and chronic diseases lead better, healthier lives.
Our strategy
Building on our history of global leadership in the treat-
ment of iron deficiency, we have used our expertise in
research and development, in-licensing, manufacturing,
regulatory affairs and commercialisation to expand into
the complementary fields of nephrology and cardio-renal
therapies. By focusing on in-licensing new products,
in-house development using our expertise in iron-based
therapies and building strong partnerships, we bring
innovative products and services to patients around the
world.
Our three strategic growth drivers
Ferinject®/Injectafer®
Vifor Fresenius Medical Care Renal Pharma (VFMCRP)
Veltassa®
Vifor Pharma Ltd. Half-year Report 2019 9
Half Year Report 2019_English_1 9 05.08.2019 13:10:58PERFORMANCE
OVERVIEW
KEY PROFIT AND LOSS FIGURES Investments in R&D amounted to CHF 109.4
million compared to CHF 91.9 million in the prior
Vifor Pharma Group net sales grew to CHF 913.3 period. The increase was driven by the initiation
million, a strong increase of 22.2% compared to of the DIAMOND study for Veltassa®.
the previous year or 21.0% on a constant currency
basis. EBITDA increased to CHF 254.6 million General and administration expenses amount-
compared to CHF 192.0 million in the prior ed to CHF 83.8 million compared to CHF 82.3
period, an increase of 32.6%. This increase was million in the prior period. The increase is mainly
largely due to the strong growth in sales com- attributable to higher personnel cost.
bined with cost containment.
The average number of full-time employees
The application of the new leasing standard (FTE) amounted to 2,764 in H1 2019, compared to
(IFRS 16) resulted in a higher EBITDA in H1 2019 of 2,658 in H1 2018. The increase of 106 FTEs is
CHF 8.5 million. IFRS 16 was not retrospectively driven by an expansion of Vifor Pharma’s com-
applied and thus the comparative 2018 reporting mercial and production workforce.
period was not restated.
Depreciation and amortisation amounted to
Other operating income declined to CHF 20.4 CHF 106.0 million compared to CHF 76.7 million
million from CHF 41.0 million in the prior period. in the prior period and are mainly included in cost
This was primarily due to the expected decrease of sales (84% and 89%, respectively) as intangible
of royalty payments from CellCept® as well as assets amortisation, principally for Veltassa® and
lower income from partnering activities. Mircera® rights.
Cost of sales amounted to CHF 373.3 million The net financial result amounted to an expense
compared to CHF 288.1 million in the prior of CHF 8.9 million in H1 2019 compared to
period, resulting in a gross profit margin of an income of CHF 41.8 million in H1 2018. The
60.0% compared to 63.5% in H1 2018. The strong decrease compared to H1 2018 is mainly due to
growth of higher margin products such as the material foreign exchange gain of CHF 42.9
Ferinject®/Injectafer® was offset by decreasing million in H1 2018 on USD denominated inter-
CellCept® royalties, lower partnering income company loans which were settled on 30 June
as well as increasing asset amortisation related 2018.
to Mircera® rights.
Tax expense amounted to CHF 13.8 million in
Marketing and distribution expenses amounted H1 2019 corresponding to an effective tax rate of
to CHF 218.5 million, up 3.6% from the prior 9.9%. The approval of the Swiss tax reform in
period. The main drivers were the investments May 2019 did not have a material impact on the
in pre-launch activities and the commercial tax expense in 2019.
organisations to further grow Ferinject®, as well
as the continued rollout of Veltassa®.
10 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 10 05.08.2019 13:10:58Net profit after minorities for H1 2019 de- FINANCIAL POSITION
creased to CHF 65.2 million compared to
CHF 118.0 million in the prior period. The de- Goodwill and intangible assets amounted to
crease is mainly due to the exceptional foreign CHF 2,643.0 million at the end of H1 2019
exchange gain on USD denominated inter compared to CHF 2,676.0 million at the end of
company loans of CHF 42.9 million in the prior 2018, representing 59.0% of total assets (end
year as well as higher tax expenses. of 2018: 59.5%).
Core earnings per share amounted to CHF 2.11 Net debt was CHF –242.8 million resulting
in H1 2019, a decrease of 20.7% compared to in a net-debt-to-EBITDA ratio of 0.54 at the end
CHF 2.66 in H1 2018. The decrease is due to the of H1 2019. This is compared to net debt of
exceptional foreign exchange gain of CHF 42.9 CHF –179.7 million at the end of 2018. The
million as well as tax gains due to unrecognised increase was driven by the dividend distributions
tax losses of CHF 22.4 million in the previous year. of CHF 174.7 million in H1 2019.
Excluding these exceptional impacts in H1 2018
core earnings increased by 27.8%. Core earnings With CHF 3,311.7 million of shareholders’ equity,
are defined as reported earnings after minorities Vifor Pharma Group had a strong equity ratio of
adjusted for proportionate amortisation of 74.0% at the end of H1 2019 compared to 74.8%
intangible assets of CHF 71.9 million in H1 2019 at the end of 2018. The slight decrease is mainly
(H1 2018: CHF 54.5 million). due to the recognition of lease liabilities with the
adoption of IFRS 16. The return on equity after
CASH FLOWS minorities amounted to 2.2% in H1 2019, com-
pared to 3.9% in H1 2018.
Cash flow from operating activities amounted
to CHF +197.9 million compared to CHF +38.4
million in the prior period. The increase is due
to the strong operating result of Vifor Pharma in
H1 2019 as well as an optimised net working
capital.
Cash flow from investing activities amounted
to CHF –71.1 million due to upfront and mile-
stone payments for in-licensing agreements of
CHF –52.4 million, mainly in respect of the
extension of commercialisation rights of Mircera®
of CHF –37.7 million.
Cash flow from financing activities amounted
to CHF –202.9 million and was mainly influenced
by dividend distributions of CHF –174.7 million,
whereof CHF –45.0 million was paid to Fresenius
Medical Care and CHF –129.7 million was distrib-
uted to shareholders of Vifor Pharma in May 2019.
Vifor Pharma Ltd. Half-year Report 2019 11
Half Year Report 2019_English_1 11 05.08.2019 13:10:58KEY GROWTH
HALF-YEAR REPORT
DRIVERS
2019
OUR PRODUCTS
12 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 12 05.08.2019 13:10:58TABLE OF CONTENTS
Key growth drivers
14 Ferinject®/Injectafer®
18 Vifor Fresenius Medical Care Renal Pharma
18 RENAL ANAEMIA MANAGEMENT
18 – Erythropoiesis-Stimulating Agents (ESAs)
18 – Mircera®
18 – Retacrit™
18 – Venofer®
19 – Vadadustat
19 MINERAL AND BONE MANAGEMENT
19 – Velphoro®
19 – Rayaldee®
20 KIDNEY FUNCTION PRESERVATION
20 – Avacopan
20 – CCX140
20 CONDITIONS ASSOCIATED WITH KIDNEY IMPAIRMENT
AND ITS TREATMENT
20 – CR845
22 Veltassa®
24 Other products
24 – Maltofer®
24 – VIT-2763
25 O M PHARMA
25 – Broncho-Vaxom®
25 – Uro-Vaxom®
25 – Doxium®
Vifor Pharma Ltd. Half-year Report 2019 13
Half Year Report 2019_English_1 13 05.08.2019 13:10:58KEY GROWTH DRIVERS
FERINJECT®/INJECTAFER®
Our first key growth driver Ferinject®/Injectafer® (ferric
carboxymaltose) is the market-leading intravenous (i.v.) iron
therapy. Ferinject® is commercialised in the US and Belgium
under the brand name Injectafer®. By the end of June 2019,
the product held the leadership position in i.v. iron therapy,
with market approval in 81 countries and over 10 million
patient years of experience.
1
With a favourable benefit-risk profile, Ferinject®/
BILLION
Injectafer® continues to unlock the broad unmet
Ferinject® in-market medical need for the treatment of iron deficiency
and iron deficiency anaemia, in key therapy areas
sales in CHF potentially such as chronic heart failure, nephrology, patient
already in 2019 blood management (PBM), women’s health and
gastroenterology.
81
Clinical guidelines support the need for i.v. iron
and in particular for Ferinject®/Injectafer® in
countries where a number of disease areas. These include cardiol-
ogy guidelines (European Society of Cardiology
Ferinject®/Injectafer®
for the diagnosis and treatment of acute and
has been approved chronic heart failure) and gastroenterology
guidelines (European Consensus on the Diagno-
sis and Management of Iron Deficiency and
10
Anaemia in Inflammatory Bowel Diseases).
MILLION
Ferinject®/Injectafer® is on track to achieve
in-market sales in excess of CHF 1 billion on
years of a rolling annual basis in the second half of 2019,
a year earlier than previously anticipated.
patient experience
14 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 14 05.08.2019 13:10:59REPORTED NET SALES IN H1 2019 IMPORTANT AWARENESS ACTIVITIES
OUTSIDE THE US
In H1 2019, overall reported net sales of
Ferinject®/Injectafer® increased to CHF 273.4 In line with our commitment to further build
million, up 19.4% from CHF 229.0 million versus awareness, improve diagnosis and ensure
the same prior-year period. This is in line with treatment of the unmet medical need, we
Vifor Pharma’s commitment to full year growth in launched several key initiatives during the first
excess of 20% at constant exchange rates. half of 2019. Among them were global awareness
raising efforts on iron deficiency in chronic heart
failure, including a strong presence at the
GLOBAL IN-MARKET SALES European Society of Cardiology (ESC) congress
on Heart Failure (HFA) in Athens in May 2019 and
Vifor Pharma closely monitors in-market sales to the European Renal Association-European
determine actual growth rates for the product. Dialysis and Transplant Association ERA-EDTA
The latest available IQVIA data from March 2019 in Budapest in June 2019.
indicates global moving annual total (MAT) sales
of Ferinject®/Injectafer® of approximately In addition, our awareness initiatives highlight
CHF 946 million, an increase of 27% versus the and promote the fact that ESC guidelines for the
same prior-year period. This strong growth diagnosis and treatment of acute and chronic
was primarily driven by gastroenterology and heart failure reference Ferinject® as the recom-
women’s health in the US, and by chronic heart mended treatment option for chronic heart failure
failure and PBM in Europe. patients with iron deficiency. Vifor Pharma also
continues to support online education of health-
care professionals (HCPs) who treat iron deficiency
INJECTAFER® (US) with a particular focus in chronic heart failure.
Injectafer® continues to drive the growth of the
i.v. iron market in the US. Vifor Pharma’s US GEOGRAPHIC EXPANSION
partner American Regent, Inc., a member of the
Daiichi-Sankyo Group, recorded net sales of In March 2019, our partner in Japan, Zeria
USD 215.9 million in H1 2019, an increase of 19.4% Pharmaceutical Co., Ltd. received the certificate
compared to H1 2018. This strong double-digit of approval for manufacture and sale of Ferinject®,
net sales growth occurred despite the one-time which is a key step in building access to the
sales gains in the same period for 2018 due to Japanese market. Ferinject® will be launched in
a general US market shortage of INFeD®. In the Japan in H2 2019, pending reimbursement
US, Vifor Pharma received a portion of American pricing approval. Ferinject® will be the first high
Regent’s reported Injectafer® net sales, resulting dose i.v. iron available on the Japanese market,
in reported net sales of CHF 73.6 million in where there is a significant unmet need in
H1 2019, a 23.7% increase compared to CHF 59.5 women’s health and gastroenterology.
million in H1 2018.
Vifor Pharma Ltd. Half-year Report 2019 15
Half Year Report 2019_English_1 15 05.08.2019 13:10:59KEY GROWTH DRIVERS
16 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 16 05.08.2019 13:11:00LIFE CYCLE MANAGEMENT FAIR-HF21 is an investigator-initiated study, led
by the University Medical Center Hamburg-
Ferinject®/Injectafer® has been studied and Eppendorf, Germany, and supported by The
proven in 28 published randomised intervention- German Centre for Cardiovascular Research and
al clinical trials. Vifor Pharma continues to invest by an unrestricted educational grant from Vifor
in additional clinical studies, including its own Pharma. The objective of this study is to show that
trials and investigator-initiated trials, to demon- treatment of patients with systolic heart failure
strate the safety and efficacy of Ferinject®/ and iron deficiency with intravenous (i.v.) iron
Injectafer® treatment on various patient groups. (Ferric Carboxymaltose, FCM) versus placebo
(i.v. NaCl) can reduce the rate of the combined
A key focus area for ongoing clinical trials is endpoint of recurrent heart failure hospitalisa-
chronic heart failure, as up to 50% of patients with tions and cardiovascular death during at least
this condition are iron deficient. Iron deficiency 12 months follow-up. Approximately 1,200 patients
in chronic heart failure is associated with reduced are expected to be enrolled in several countries.
quality of life, lessened exercise capacity and Results of this study are expected in 2020.
increased risk of hospitalisation. Previous clinical
studies (FAIR-HF, CONFIRM-HF, EFFECT-HF) have Vifor Pharma’s US partner, American Regent, Inc.
demonstrated significant beneficial effects of is conducting one of the largest studies of i.v. iron
Ferinject® on symptoms, quality of life and in heart failure, the HEART-FID study. HEART-FID
exercise capacity. As part of its ongoing commit- is a randomised, double-blind, multi-centre,
ment to improving the lives of heart failure prospective, placebo-controlled study to enrol
patients, Vifor Pharma supports two large over 3,000 patients to assess the efficacy and
mortality and morbidity outcomes studies in safety of Injectafer® in heart failure with iron
chronic heart failure – the AFFIRM-AHF study and deficiency and reduced ejection fraction. Results
the FAIR-HF2 study. Vifor Pharma’s US partner, are expected in 2022.
American Regent, is conducting the HEART-FID
study.
The AFFIRM-AHF study, conducted by Vifor
Pharma, is a multi-centre, randomised, controlled
trial with 1,100 patients. AFFIRM-AHF is designed
as the first study to evaluate the benefit of
Ferinject®, in patients hospitalised due to acutely
decompensated heart failure receiving Ferinject®
treatment after stabilising from the acute episode
and prior to exiting the hospital. Results from this
study are expected by the end of 2020, which will
add to the wealth of evidence that the European
Society of Cardiology uses to define and promote
its guidelines – particularly around the role of iron
in chronic heart failure.
1 Clinicaltrials.gov
Vifor Pharma Ltd. Half-year Report 2019 17
Half Year Report 2019_English_1 17 05.08.2019 13:11:00KEY GROWTH DRIVERS
VIFOR FRESENIUS MEDICAL CARE
RENAL PHARMA (VFMCRP)
The second strategic growth driver is Mircera® is a long-acting ESA, licensed from
F. Hoffmann-La Roche to treat symptomatic
Vifor Fresenius Medical Care Renal Pharma, anaemia associated with chronic kidney disease
our joint company with Fresenius Medical (CKD). Vifor Pharma has exclusive rights to com-
mercialise Mircera® in the US and its territories.
Care. VFMCRP is dedicated to addressing the
needs of chronic kidney disease (CKD)
RETACRIT™
patients, both in pre-dialysis and dialysis.
Reported net sales of Retacrit™ (epoetin alfa-
epbx) in H1 2019 amounted to CHF 2.9 million,
following the initiation of commercial activities
in November 2018.
Retacrit™ injection is a short-acting ESA and the
first and only biosimilar ESA approved for
marketing in the US. Vifor Pharma licensed rights
The expanding product portfolio of VFMCRP is from Pfizer to commercialise Retacrit™ in the
focused on distinct comorbidities and complica- US dialysis and non-hospital nephrology market,
tions in CKD patients. This includes renal anaemia enabling Vifor Pharma to offer customers a
management, mineral and bone disease manage- full range of ESA treatment options addressing
ment, kidney function preservation and improve- patient needs.
ment, CKD-associated complications and
cardio-renal management including hyperkalae-
mia and iron deficiency. VFMCRP is a unique VENOFER®
company that combines Vifor Pharma’s pharma-
ceutical expertise with Fresenius Medical Care’s In H1 2019, net sales of Venofer® increased by
experience in dialysis patient care. 9.6% versus prior year to CHF 65.4 million. The
majority of Venofer® sales continue to be in the
US where it is the market leading intravenous (i.v.)
RENAL ANAEMIA MANAGEMENT iron in haemodialysis usage.
ERYTHROPOIESIS-STIMULATING AGENTS (ESAs) Venofer® (iron sucrose (iron (III)-hydroxide
(MIRCERA®, RETACRIT™) sucrose complex) is the trusted gold standard in
iron therapy for anaemic dialysis patients and is
MIRCERA® the originator i.v. iron sucrose product. During
the first half of 2019, Venofer® continued to be the
Net sales of Mircera® (methoxy polyethylene leading i.v. iron brand in terms of volume world-
glycol-epoetin beta) continued to increase in wide with more than 25 million patient years’
H1 2019 to CHF 276.2 million, an increase experience by the end of H1 2019.
of 29.0% compared to the prior year period.
Venofer® is a nanomedicine and recognised
The increase in sales was primarily driven by by the US FDA as a non-biological complex drug.
gaining additional market share in both H2 2018 The positive experience of generations of
and H1 2019, with mid-sized and independent physicians and patients compared to other
dialysis organisations in the US. nanoparticle-based iron products (iron sucrose
similars) has helped to secure the position of
18 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 18 05.08.2019 13:11:00Venofer® in the highly competitive environment MINERAL AND BONE MANAGEMENT
of low-dose i.v. iron products. The tolerability
of Venofer® is a key differentiator and one of the VELPHORO®
main reasons the brand retains strong demand
after many decades on the market. Net sales of the phosphate binder, Velphoro®
increased by 126.6% in H1 2019 to CHF 81.1
million, from CHF 35.8 million in 2018. The strong
VADADUSTAT growth is mainly driven by the US market, where
IN DEVELOPMENT in-market sales increased by 57.1% to CHF 197.4
million in Q1 2019.
Vadadustat is an oral hypoxia-inducible factor
(HIF) prolyl hydroxylase inhibitor, currently In 2017, KDIGO (Kidney Disease Improving Global
in global phase-III development by Akebia Outcomes) who develop evidence-based clinical
Therapeutics, Inc., a US NASDAQ quoted bio practice guidelines in kidney disease, updated
pharmaceutical company, for the treatment their CKD-Mineral and Bone Disorder guidelines
of anaemia associated with chronic kidney to recommend the use of non-calcium-based
disease (CKD). phosphate binders for the control of phosphate
levels. This has resulted in continued adoption
In April 2019, Vifor Pharma and Akebia expanded by physicians.
a previously signed licence agreement to sell
vadadustat to Fresenius Medical Care North Velphoro® (Polynuclear Iron (III) – Oxyhydroxide,
America, to also include a license to sell vadadus- Sucroferric Oxyhydroxide) is a non-calcium,
tat to certain third-party dialysis organisations in iron-based, chewable phosphate binder approved
the US. This amended licence extends the for the control of phosphate levels in the blood
potential opportunity for vadadustat to access in adults with chronic kidney disease (CKD) on
up to 60% of US dialysis patients. dialysis.
The licence, which is subject both to vadadustat’s Growing real-world evidence continues to
approval by the US Food and Drug Administration demonstrate the benefits of Velphoro® for
(FDA) and inclusion in the Centers for Medicare patients, with approximately twice as many
and Medicaid (CMS) End Stage Renal Disease achieving and maintaining target serum phos-
Prospective Payment System (ESRD PPS), will now phate levels with half the pill burden, when
also be effective during the Transitional Drug switched from other phosphate binders. A lower
Add-on Payment Adjustment (TDAPA) two-year pill burden can increase adherence and lead to
period that is expected to precede the ESRD lower phosphate levels. Real life data also
bundle period. suggests improved nutritional status which has
been associated with improved quality of life
Akebia’s phase-III clinical development pro- for dialysis patients.
gramme includes INNO2VATE, with the enrolment
of approximately 3,900 dialysis patients complete.
Top-line readout of INNO2VATE is expected RAYALDEE®
in Q2 2020. Akebia’s overall clinical programme PRE-COMMERCIAL
includes evaluation of both daily and three-times-
weekly dosing protocols in non-dialysis and Rayaldee® is an orally administered, extended-
dialysis patients, respectively. Vadadustat is release formulation of calcifediol, a prohormone of
an investigational therapy and is not yet approved the active form of vitamin D3, for the treatment of
by the FDA or any regulatory authority. secondary hyperparathyroidism (SHPT) in patients
Vifor Pharma Ltd. Half-year Report 2019 19
Half Year Report 2019_English_1 19 05.08.2019 13:11:00KEY GROWTH DRIVERS
with chronic kidney disease (CKD) with vitamin D VFMCRP has a licensing agreement with Chemo-
insufficiency. Vifor Fresenius Medical Care Renal Centryx, Inc., a NASDAQ-quoted biotechnology
Pharma (VFMCRP) obtained the rights from OPKO company, to commercialise avacopan outside
Health Inc., for this indication in key European the US.
markets and selected markets outside Europe.
In April 2019, European authorities accepted the CCX140
marketing authorisation application for Rayaldee® IN DEVELOPMENT
for the treatment of secondary hyperparathy-
roidism in adult non-dialysis CKD patients. CCX140 is an orally administered small molecule
VFMCRP is seeking marketing authorisation that is a highly potent and selective inhibitor
through the decentralised procedure in selected of the chemokine receptor CCR2. VFMCRP and
European countries. In June 2019, marketing ChemoCentryx have launched a joint clinical
authorisation application was also submitted in development programme for CCX140 in patients
Switzerland. Approvals are expected in 2020. with focal segmental glomerulosclerosis (FSGS).
FSGS causes protein loss from the kidneys and
progressive kidney failure. Inhibiting the actions
KIDNEY FUNCTION PRESERVATION of the CCR2 receptor may reduce proteinuria and
preserve renal function through podocyte
AVACOPAN protection, as well as the reduction in mono-
IN DEVELOPMENT cyte-driven inflammation.
Avacopan is an orally administered, highly selec- Two clinical trials LUMINA 1 and LUMINA 2 are
tive inhibitor of the complement C5a receptor1 currently underway. The first trial in patients with
(C5aR1), being developed for the treatment of moderate-to-severe protein loss in FSGS, and the
orphan and rare renal diseases such as anti-neu- second in patients with severe protein loss and
trophil cytoplasmic auto-antibody-associated clinical nephrotic syndrome primary FSGS.
vasculitis (ANCA-associated vasculitis) and C3 Clinical readout is expected in 2020 and will
glomerulopathy (C3G). Prior studies have shown determine the next steps in clinical development.
the clinical and patient experience benefits
of selectively blocking the C5aR1 which leads VFMCRP has a licensing agreement with Chemo-
to pathological pro-inflammatory responses. Centryx, Inc. to commercialise CCX140 outside
the US.
The pivotal phase-III ADVOCATE trial data
readout is expected in Q4 2019. This is the largest
controlled trial in active ANCA-associated CONDITIONS ASSOCIATED WITH KIDNEY
vasculitis, with more than 300 patients recruited IMPAIRMENT AND ITS TREATMENT
globally during 52 weeks of treatment.
CR845
ChemoCentryx has also advanced enrolment in IN DEVELOPMENT
the randomised controlled clinical phase-IIb trial
of avacopan in patients with the very rare kidney In the US, VFMCRP and Cara Therapeutics,
disease C3G. C3G is a rare disorder most often Inc. will promote the investigational medicine to
seen in younger patients which can progress to FMCNA (Fresenius Medical Care North America)
end stage renal failure with risk of recurrent dialysis clinics under a profit-sharing arrange-
disease after transplantation. There is currently ment.
no approved treatment for this rare disease.
20 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 20 05.08.2019 13:11:00CR845 is a peripherally restricted kappa opioid In May 2019, Cara Therapeutics, Inc. announced
agonist that targets the peripheral neurons and positive results from the KALM-1 US phase-III trial,
immune cells. Chronic kidney disease-associated with statistically significant improvements in the
pruritus (CKD-aP) is a devastating systemic primary and all secondary endpoints in subjects
itching condition that occurs with high frequency undergoing haemodialysis with CKD-aP. CR845
and intensity in patients with chronic kidney was generally well tolerated with a safety profile
disease undergoing haemodialysis. It affects consistent with that seen in earlier clinical trials.
approximately 60–70% of all patients on dialysis.
Moderate-to-severe CKD-aP is associated with A second phase-III trial (KALM-2) continues to
poor quality of life, depression, and reflects enrol haemodialysis patients with CKD-aP
an independent predictor of mortality among globally, with top line data expected in H2 2019
haemodialysis patients. There are currently based on current enrolment expectations. If
no approved therapies in Europe or the US for approved, CR845 will be the first medicine for
treatment of CKD-aP. this indication outside of Japan.
CR845 has demonstrated significant reductions Vifor Fresenius Medical Care Renal Pharma
in itch intensity and improvement in quality of (VFMCRP) has a licensing agreement with Cara
life measures in haemodialysis patients with Therapeutics, Inc., a NASDAQ-quoted bio
moderate-to-severe CKD-aP. It has been specifi- technology company, to commercialise CR845
cally designed to mitigate the drawbacks or side (difelikefalin) for the treatment of CKD-aP in
effects typically observed with opiates. patients undergoing dialysis globally, excluding
the US, Japan and South Korea.
Vifor Pharma Ltd. Half-year Report 2019 21
Half Year Report 2019_English_1 21 05.08.2019 13:11:01KEY GROWTH DRIVERS
VELTASSA®
Our third strategic growth driver is Veltassa® (patiromer),
a treatment for hyperkalaemia (elevated serum potassium
levels). Hyperkalaemia is often asymptomatic and can
lead to arrhythmia, hospitalisation and sudden death.
Hyperkalaemia is frequently associated with chronic kidney
disease (CKD) and chronic heart failure and with the
use of life-saving renin-angiotensin-aldosterone system
inhibitors (RAASi) medications.
69.9%
In H1 2019, net sales of Veltassa® increased
to CHF 62.6 million compared with CHF 36.8
million in H1 2018, an increase of 69.9% (or
65.3% on a constant currency basis), where
growth was mostly driven by the US. Net sales
in the US were CHF 59.4 million (USD 59.4
million), a significant increase compared to
net sales increase CHF 36.3 million (USD 37.4 million) in H1 2018.
The H1 2019 net sales performance of Veltassa®
confirms our expectation that Veltassa® will
grow by approximately 50% on a full year basis
in 2019.
100,000
more than Since FDA approval and launch in 2015, Veltassa®
has experienced steady and sustained growth,
while also driving the expansion of the US
potassium binder market from CHF 172.8 million
in 2016 to CHF 253.9 million in 2018. More than
15,000 physicians had prescribed Veltassa® to
more than 100,000 patients since launch in the
US at the end of H1 2019, making among the
patients treated fastest growing drugs in nephrology in the last
ten years.
22 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 22 05.08.2019 13:11:01REIMBURSEMENT AND REGULATORY Vifor Pharma is also now investing in the DIAMOND
APPROVALS phase-IIIb study which is designed to evaluate the
potential of Veltassa® in combination with RAASi
In May 2019, the AMNOG process for Veltassa® medications. DIAMOND is an outcome-based
in Germany completed, with Veltassa® now study addressing cardiovascular mortality and
successfully reimbursed. Reimbursement was hospitalisation rates. The first patient was
also gained in Belgium and, most recently, in enrolled in the DIAMOND study in May 2019. The
Spain. As of 30 June 2019, Veltassa® has been study is a global, multicentre, double-blind,
launched in Sweden, Norway, Denmark, placebo-controlled trial aiming to study approxi-
Belgium and Germany. Further reimbursement mately 2,400 patients in over 400 sites. DIAMOND
negotiations and launches will continue in line will include patients with heart failure (with or
with individual reimbursement process timelines without CKD) and either current hyperkalaemia at
across Europe throughout 2019 and 2020. screening, or a history of hyperkalaemia in the
past year, which led to a reduction or discontinua-
tion of RAASi therapy. The primary endpoint of
TRANSFORMING THE TREATMENT the study is the time-to-first occurrence of
OF HYPERK ALAEMIA cardiovascular death or cardiovascular hospitali-
sation. Top-line results are expected in 2022.
Veltassa® is the first drug to offer an effective and
well tolerated innovation for cardiologists and In June 2019, the European Medicines Agency
nephrologists in the long-term management of (EMA) approved a supplemental new drug
hyperkalaemia in CKD and chronic heart failure application to enable the use of Veltassa® with
patients. or without food, potentially providing patients
with greater flexibility in incorporating Veltassa®
Vifor Pharma is committed to investing in data in their daily treatment regimen. The label
generation programmes to drive evidence-based update was based on results from the phase-IV
best practice using Veltassa® in this patient TOURMALINE study, which showed no statisti-
population. The AMBER study, a phase-II trial, was cally significant difference between the groups
presented in May 2019 at the National Kidney taking Veltassa® with or without food in achieving
Foundation Congress in Boston, USA. The study serum potassium levels within the target range
demonstrated that a significantly higher propor- (3.8 to 5.0 mEq/L). The Federal Drug Administra-
tion of patients with CKD and resistant hyper tion (FDA) had previously approved the label
tension taking Veltassa®, remained on guideline update based on the TOURMALINE results in
recommended spironolactone therapy, com- May 2018.
pared to patients taking placebo at week 12.
Vifor Pharma Ltd. Half-year Report 2019 23
Half Year Report 2019_English_1 23 05.08.2019 13:11:01OUR PRODUCTS
OTHER PRODUCTS
In addition to the leading intravenous (i.v.) iron therapies,
Ferinject®/Injectafer® and Venofer®, Vifor Pharma develops
and commercialises other products for iron deficiency and
more recently for iron overload.
MALTOFER® VIT-2763
IN DEVELOPMENT
Net sales of Maltofer® decreased by 13.2%
compared to the prior year to CHF 29.6 million. Vifor Pharma is using its expertise in understanding
This decrease reflects a change in the order the chemistry and biology of iron to develop
schedule of our partners compared to the prior VIT-2763, the first oral ferroportin inhibitor with the
year, mainly in Saudi Arabia, Kuwait, the potential for treating diseases with ineffective
United Arab Emirates, Qatar, Bahrain, Oman erythropoiesis and iron overload conditions, such
and Latin America. as beta-thalassemia.
Maltofer® (Iron polymaltose complex) plays a Following the positive phase-I study results
key role in the management of patients with iron reported at the beginning of 2019, Vifor Pharma
deficiency. It is the originator oral iron poly will start a phase-II trial in beta-thalassemia in the
maltose complex (IPC) and is a widely accepted second half of 2019. This randomised, controlled,
and well-tolerated oral iron therapy for infants, multinational trial will be conducted in patients
children, adolescents and pregnant women. with non-transfusion-dependent beta-thalassemia
and documented iron overload.
In June 2019, both the FDA and the EMA granted
an orphan drug designation for VIT-2763.
24 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 24 05.08.2019 13:11:01OM PHARMA PRODUCTS Uro-Vaxom® (lyophilized bacterial extract) is
an extract of the bacterium Escherichia coli for
We continue to optimise our infectious diseases the treatment and prevention of recurrent urinary
and over-the-counter and prescription product tract infections. It stimulates the immune system
(ID/OTx) portfolio to deliver value to a focused and the body’s natural defences against urinary
group of patients with high unmet medical need. pathogens. There is a high medical need to
prevent recurrent urinary tract infections, with
The three leading products in the ID/OTx port Uro-Vaxom® listed in various international and
folio are Broncho-Vaxom®, Uro-Vaxom® and local guidelines.
Doxium®.
DOXIUM®
BRONCHO-VA XOM®
Net sales of Doxium® in H1 2019 were CHF 9.8
Net sales of Broncho-Vaxom® decreased 17.2% to million, a decrease of 9.4% compared to prior
CHF 21.6 million in H1 2019 compared to the year. This decrease was due to the phasing of
previous year. This decrease was primarily due to shipments in China. The overall in-market perfor-
phasing in Russia which is a key market. However, mance in key emerging pharma markets such
in-market sales of Broncho-Vaxom® were strong as Brazil, Turkey, Egypt and China was strong, with
with an increase of 15% in volume during the past growth of 20% in volume (Q1 2018 vs Q1 2019
winter season (October 2018 to March 2019). moving annual total).
Broncho-Vaxom® (lyophilized bacterial lysates) is Doxium® (calcium dobesilate) is used for the oral
an extract of different bacterial species used for treatment of diabetic retinopathy, signs of chronic
the treatment and prevention of recurrent respira- venous insufficiency in the lower limbs (pain,
tory infections. It stimulates the immune system cramps, paraesthesia, oedema, stasis dermatosis)
and the body’s natural defences against a wide and haemorrhoidal syndrome.
spectrum of respiratory pathogens.
URO-VA XOM®
Net sales of Uro-Vaxom® in H1 2019 were CHF 8.4
million, an increase of 9.2% compared to the
previous year. Overall market profitability and
market share have been increasing consistently
in recent years.
Vifor Pharma Ltd. Half-year Report 2019 25
Half Year Report 2019_English_1 25 05.08.2019 13:11:0126 Vifor Pharma Ltd. Half-year Report 2019 Half Year Report 2019_English_1 26 05.08.2019 13:11:02
2019 OUTLOOK
AND FINANCIAL GUIDANCE
2019 OUTLOOK 2019 NET SALES EXPECTED GROWTH
MARKET ACCESS
Ferinject® is expected to be launched in Japan in H2 2019, subject to obtaining
reimbursement.
>15%
The go-to-market strategy in China for Ferinject® will be announced before
the end of 2019.
We expect to partner for the Japanese rights of CCX140 in H2 2019.
2019 EBITDA EXPECTED TO INCREASE
CLINICAL TRIALS
The phase-II trial of VIT-2763 (ferroportin inhibitor) in beta-thalassemia patients
is planned to start in H2 2019.
25–30%
The results of the global phase-III ADVOCATE study of avacopan for anti-
neutrophil cytoplasmic auto-antibody-associated vasculitis (ANCA-associated
vasculitis) are expected in Q4 2019.
The second global pivotal phase-III trial (KALM-2) of CR845 that is being conducted 2020 EXPECTED NET SALES
by Cara Therapeutics, Inc. is expected to read-out by the end of 2019.
BUSINESS DEVELOPMENT >2 BILLION
One additional in-licensing, product acquisition or corporate transaction is CHF
expected before the end of 2019.
FINANCIAL GUIDANCE 2020 EBITDA EXPECTED
IN THE RANGE OF
In 2019 at constant exchange rates, Vifor Pharma net sales are expected to
exceed 15%, reported EBITDA is expected to grow between 25% and 30%.
In 2020 net sales are expected to exceed CHF 2 billion and EBITDA to be
in the range of CHF 700 million. Going forward the dividend is expected to
remain at the current level of CHF 2 per share.
700 MILLION
CHF
Vifor Pharma Ltd. Half-year Report 2019 27
Half Year Report 2019_English_1 27 05.08.2019 13:11:02HALF-YEAR REPORT 2019
CONSOLIDATED INTERIM
FINANCIAL STATEMENTS
28 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 28 05.08.2019 13:11:02TABLE OF CONTENTS
30 Consolidated statement of income
31 Consolidated statement of
comprehensive income
32 Consolidated statement of financial position
33 Consolidated statement of changes in equity
34 Consolidated statement of cash flows
35 Notes to the consolidated financial statements
Vifor Pharma Ltd. Half-year Report 2019 29
Half Year Report 2019_English_1 29 05.08.2019 13:11:02CONSOLIDATED INTERIM FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT
OF INCOME
2019 2018
in million CHF — unaudited figures 1.1.—30.6. 1.1.—30.6.
Net sales 913.3 747.4
Other income 20.4 41.0
Cost of sales (373.3) (288.1)
Gross profit 560.3 500.2
Marketing and distribution (218.5) (210.9)
Research and development (109.4) (91.9)
General and administration (83.8) (82.3)
Operating profit (EBIT) 148.7 115.2
Financial income 5.9 47.5
Financial expenses (14.8) (5.7)
Profit before income taxes (EBT) 139.8 157.0
Income taxes (13.8) 1.0
Net profit 126.0 158.0
Attributable to:
››Shareholders of Vifor Pharma Ltd. 65.2 118.0
››Non-controlling interests 60.9 40.0
Earnings per share in CHF
Basic earnings per share 1.00 1.82
Diluted earnings per share 1.00 1.82
30 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 30 05.08.2019 13:11:03CONSOLIDATED INTERIM FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT
OF COMPREHENSIVE INCOME
2019 2018
in million CHF — unaudited figures 1.1.—30.6. 1.1.—30.6.
Net profit 126.0 158.0
Hedging transactions
››Change in fair value (4.5) (0.6)
››Realised in profit or loss 3.6 (0.7)
Translation differences 4.1 (10.9)
Items that will be reclassified
subsequently to profit or loss 3.2 (12.2)
Remeasurements of the net
defined benefit liability/asset (0.2) (0.7)
Change in fair value of equity securities measured through OCI (9.5) 15.7
Income taxes 0.7 (2.6)
Items that will not be reclassified
to profit or loss (9.0) 12.4
Other comprehensive income (5.8) 0.2
Total comprehensive income 120.2 158.2
Attributable to:
››Shareholders of Vifor Pharma Ltd. 61.2 108.7
››Non-controlling interests 59.1 49.5
Vifor Pharma Ltd. Half-year Report 2019 31
Half Year Report 2019_English_1 31 05.08.2019 13:11:03CONSOLIDATED INTERIM FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT
OF FINANCIAL POSITION
2019 2018
in million CHF — unaudited figures 30.6. 31.12.
Cash and cash equivalents 321.5 400.3
Financial assets 0.8 2.4
Trade and other receivables 522.3 509.0
Income tax receivables 6.5 14.3
Inventories 319.4 281.7
Prepaid expenses and accrued income 40.3 41.2
Current assets 1,210.9 1,248.8
Property, plant and equipment 271.6 274.0
Right-of-use assets 1
70.1 -
Intangible assets 2,643.0 2,676.0
Financial assets 199.3 208.2
Deferred tax assets 82.9 88.4
Non-current assets 3,266.9 3,246.7
Assets 4,477.8 4,495.5
Financial liabilities 100.4 116.2
Lease liabilities 1 14.7 -
Trade and other payables 110.1 156.4
Income tax payables 83.0 80.6
Accrued expenses and deferred income 267.5 240.0
Provisions 5.5 1.3
Current liabilities 581.3 594.4
Financial liabilities 490.9 492.4
Lease liabilities 1
63.1 -
Deferred tax liabilities 19.2 34.4
Employee benefit liabilities 9.7 9.0
Provisions 1.9 0.8
Non-current liabilities 584.8 536.5
Share capital 0.7 0.7
Reserves 2,984.5 3,051.5
Equity attributable to shareholders of
Vifor Pharma Ltd. 2,985.1 3,052.1
Non-controlling interests 326.6 312.5
Shareholders' equity 3,311.7 3,364.6
Liabilities and shareholders' equity 4,477.8 4,495.5
1 As a result of the IFRS 16 adoption, new line items were included for the right-of-use assets and both current and non-current lease
liabilities. The prior year was not restated, refer to note 5.3 for further details.
32 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 32 05.08.2019 13:11:03CONSOLIDATED INTERIM FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT
OF CHANGES IN EQUITY
Foreign
currency Non-
Share Treasury Retained translation Fair value controlling Total
in million CHF — unaudited figures capital shares earnings reserves reserves Total interests equity
1 January 2018 0.7 (17.7) 3,244.7 (155.7) 1.1 3,073.1 259.4 3,332.5
Net profit - - 118.0 - - 118.0 40.0 158.0
Other comprehensive income - - 2.9 (10.9) (1.3) (9.3) 9.5 0.2
Total comprehensive income - - 120.9 (10.9) (1.3) 108.7 49.5 158.2
Dividends - - (129.6) - - (129.6) (45.0) (174.6)
Transactions on treasury shares - 0.7 (11.5) - - (10.8) - (10.8)
Share-based payments - - 7.5 - - 7.5 - 7.5
30 June 2018 0.7 (17.0) 3,232.0 (166.6) (0.2) 3,048.9 264.0 3,312.9
31 December 2018 0.7 (18.4) 3,250.5 (182.1) 1.4 3,052.1 312.5 3,364.6
Adoption of IFRS 16 1 - - (0.9) - - (0.9) - (0.9)
1 January 2019 0.7 (18.4) 3,249.6 (182.1) 1.4 3,051.2 312.5 3,363.7
Net profit - - 65.2 - - 65.2 60.9 126.0
Other comprehensive income - - (7.1) 4.0 (0.9) (4.0) (1.8) (5.8)
Total comprehensive income - - 58.0 4.0 (0.9) 61.2 59.1 120.2
Dividends - - (129.7) - - (129.7) (45.0) (174.7)
Transactions on treasury shares - 1.8 (2.2) - - (0.4) - (0.4)
Share-based payments - - 2.8 - - 2.8 - 2.8
30 June 2019 0.7 (16.6) 3,178.7 (178.0) 0.5 2,985.1 326.6 3,311.7
1 The adjustments arising from the IFRS 16 adoption, effective 1 January 2019, also include an opening retained earnings impact
as the prior year was not restated. Refer to note 5.3 for further details.
At the Annual Shareholder Meeting held on 8 May 2019, a resolution was passed to pay a dividend
of CHF 2.00 per share (previous year: CHF 2.00 per share), which corresponds to a payment of
CHF 129.7 million for the financial year 2018. This was paid to the shareholders on 14 May 2019.
Vifor Pharma Ltd. Half-year Report 2019 33
Half Year Report 2019_English_1 33 05.08.2019 13:11:03CONSOLIDATED INTERIM FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT
OF CASH FLOWS
2019 2018
in million CHF — unaudited figures 1.1.—30.6. 1.1.—30.6.
Net profit 126.0 158.0
Income taxes 13.8 (1.0)
Depreciation and amortisation 106.0 76.7
Increase in provisions and employee benefit assets and liabilities 2.6 6.1
Net financial result 8.9 (41.8)
Other non-cash items 10.4 12.3
Change in trade and other receivables (14.3) (103.7)
Change in inventories (38.3) (42.9)
Change in trade and other payables (32.8) (16.8)
Change in other net current assets 27.9 35.3
Interest received 2.3 1.3
Interest paid (2.8) (5.5)
Income tax paid (11.9) (39.7)
Cash flow from operating activities 197.9 38.4
Investments in property, plant and equipment (19.6) (26.3)
Investments in intangible assets (58.3) (143.6)
Investments in financial assets and securities (1.0) (18.0)
Proceeds from property, plant and equipment 4.0 0.6
Proceeds from financial assets and securities 3.9 1.5
Cash flow from investing activities (71.1) (185.8)
Dividends paid (174.7) (174.6)
Purchase of treasury shares (4.7) (9.6)
Proceeds from financial liabilities 0.5 134.9
Repayment of financial liabilities (15.5) (114.3)
Repayment of lease liabilities (8.6) -
Cash flow from financing activities (202.9) (163.6)
Effects of exchange rate changes on cash and cash equivalents (2.7) 0.5
Decrease in cash and cash equivalents (78.8) (310.6)
Cash and cash equivalents as at 1 January 400.3 425.1
Cash and cash equivalents as at 30 June 321.5 114.5
34 Vifor Pharma Ltd. Half-year Report 2019
Half Year Report 2019_English_1 34 05.08.2019 13:11:03NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS
NOTES TO THE CONSOLIDATED
FINANCIAL STATEMENTS
These are the consolidated interim financial statements of Vifor Pharma Ltd. and its subsidiaries
(together referred to as “Vifor Pharma” or “the Group”). Vifor Pharma is a pharmaceutical company
focused on the development, manufacture and distribution of pharmaceutical products.
KEY EVENTS AND TRANSACTIONS
The financial position and performance of the Group was particularly affected by the following
transactions during the reporting period:
(i) Mircera® commercialisation rights
On 30 March 2019, the Group signed an agreement with Fresenius Medical Care for the extension
of the Mircera® commercialisation rights for the first four months of 2020 for consideration of
USD 19.5 million. The Group subsequently exercised its option for an additional USD 19.0 million
to further extend the rights until the end of August 2020. The total payments were capitalised
and will be amortised over the 8-month licence term.
The agreement includes options for Vifor Pharma to further extend the rights until the end of 2021.
(ii) Akebia Therapeutics expansion of licence agreement
On 9 April 2019, the Group announced that the terms of the licence agreement with Akebia Therapeutics
(“Akebia”) had been amended, allowing Vifor Pharma to sell vadadustat to certain third-party dialysis
organisations, for use in the US. Under the terms of the amended agreement, Akebia is eligible to
receive an additional USD 5.0 million payment, for a total of USD 25.0 million, upon approval of
vadadustat by the FDA and the earlier of the Centres for Medicare & Medicaid’s (CMS) determination
that vadadustat will be reimbursed under the Transitional Drug Add-on Payment Adjustment (TDAPA)
or included in the End Stage Renal Disease (ESRD) bundle. These future commitments will be added
to the cost of the intangible asset should they become payable.
ABOUT THESE NOTES AND FINANCIAL STATEMENTS
The notes to these consolidated interim financial statements have been organised to help users find
and understand the most relevant information. Certain information (e.g. basis of preparation and
scope of consolidation, amendments to IFRS, etc.) has been placed at the end of the document and
cross-referenced where necessary.
Vifor Pharma Ltd. Half-year Report 2019 35
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