ST GALLEN, Switzerland-Thursday 6 August 2020 [ AETOS Wire ]
Net sales and EBITDA continued to grow in H1 2020 despite challenging market conditions due to COVID-19
Ferinject®/ Injectafer® demand impacted by global COVID-19 restrictions
Sustained growth in nephrology supported by dialysis business
Veltassa® net sales impacted by reduced promotion to nephrologists due to COVID-19
Etienne Jornod stepped down as Executive Chairman; Stefan Schulze
appointed CEO of Vifor Pharma Group and Jacques Theurillat elected
non-executive Chairman in May 2020
Financial guidance 2020 updated to reflect COVID-19 impact
(BUSINESS WIRE) -- Regulatory News:
Vifor
Pharma Group reported growth in H1 2020, despite challenges to patient
access conditions caused by the COVID-19 pandemic. The financial
guidance has been updated to reflect COVID-19 impact on a full-year
basis. Restrictions caused by the COVID-19 pandemic have lowered
revenues of Ferinject®/ Injectafer® and Veltassa®. However, growth was
sustained in the nephrology area, mostly driven by the dialysis
business.
Commenting on the first half results, Stefan Schulze, CEO of Vifor Pharma Group, said:
“Despite
unprecedented challenges due to COVID-19, we are pleased to report
overall sustained revenue growth and a strong EBITDA growth in H1 2020.
The temporary impact to patient access caused by global COVID-19
restrictions has reduced revenues of Ferinject®/ Injectafer® and
Veltassa®. We maintained growth in the nephrology area, driven by the
dialysis business, further underlining the success of our therapeutic
diversification in recent years. Targeted measures were implemented
across the organisation in H1 to keep our employees safe, ensure
business continuity and product supply to patients in need and to
protect our profitability. We are proud of the efforts of our employees
and partners, which have helped minimise the consequences of the
pandemic for patients who depend on our products.”
FINANCIAL PERFORMANCE: SUSTAINED OVERALL GROWTH
Net sales of CHF 922.5 million, up 1.0% (or 4.3% in local currency)
Other income increased due to milestone payments from partnering activities
EBITDA of CHF 305.1 million, up 19.8%
Net profit before minorities of CHF 106.7 million negatively impacted
by a CHF 56.2 million impairment of the intangible asset CCX140
Strong balance sheet with equity ratio of 75.0%
Net debt position of CHF 232.9 million
FERINJECT®/ INJECTAFER®: HOSPITAL DEMAND IMPACTED BY COVID-19
Net sales of CHF 261.9 million, a decrease of 4.2%, or 0.1% in local currency
Sales in Q2 declined as COVID-19 restrictions in many markets prevented
patients from receiving infusions, we expect return to growth in H2
subject to continued normalisation of the COVID-19 situation
Strategic partnership in China signed with Fresenius Kabi in February
2020 to create a joint company focusing on i.v. iron products; NDA
submission for Ferinject® in China was accepted by the National Medical
Products Administration in June 2020
Reimbursement and launch expected in Japan in H2 2020
NEPHROLOGY GROWTH DRIVEN BY DIALYSIS BUSINESS
Erythropoiesis-Stimulating Agent (ESA) portfolio increased by 4.9% to
CHF 292.7 million (or 8.2% in local currency), mostly driven by higher
demand of Retacrit® from FKC clinics and the mid-sized and independent
segment (net sales of CHF 24.1 million, compared to 2.9 million in the
prior period). Mircera® net sales amounted to CHF 268.6 million, down
2.7% from H1 2019 (up 0.4% in local currency)
Venofer® net
sales increased by 4.5% to CHF 68.3 million (or 8.1% in local currency).
The majority of Venofer® sales continue to be in the US and the
dialysis segment
Velphoro® net sales decreased by 8.9% to CHF 73.9 million (or 6.1% in local currency), due to phasing impacts in H1 2019
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara
Therapeutics announced in April 2020 positive results from KALM-2 global
pivotal Phase-III trial, confirming positive outcome of KALM-1 study
Akebia announced in May 2020 positive results from the INNO2VATE
studies, which evaluated the safety and efficacy of vadadustat versus
darbepoetin alfa for the treatment of anaemia due to chronic kidney
disease (CKD) in adult patients on dialysis. Vadadustat achieved primary
efficacy and cardiovascular safety endpoints
In June 2020,
Reference Member State Germany announced the successful completion of
the decentralised regulatory procedure for Rayaldee® in selected EU
countries. National marketing authorisations are now expected in H2 2020
VELTASSA®: NEW PRESCRIPTIONS IMPACTED BY COVID-19 RESTRICTIONS
Net sales of CHF 59.6 million, down 4.8% (or 1.7% in local currency).
The demand was significantly affected by COVID-19 due to patient
discontinuations, postponed initiations, slow market growth, market
access challenges in the US and suspension of face-to-face promotions
Market access in Europe progressed in H1 2020 with reimbursement
approval in Finland and Portugal and formulary access agreed in the UK
outside Scotland
Otsuka Canada Pharmaceutical Inc. launched Veltassa® in Canada in May 2020
CORPORATE DEVELOPMENT
Etienne Jornod stepped down as Executive Chairman of the Board of
Directors at the 92nd Vifor Pharma Annual General Meeting on 14 May
2020, following 25 years at that helm
Jacques Theurillat elected as the new non-executive Chairman of the Board of Directors on 14 May 2020
Stefan Schulze, previously President of the Executive Committee and
Chief Operating Officer, appointed Chief Executive Officer (CEO) of
Vifor Pharma Group on 14 May 2020
Acquisition of US Food and
Drug Administration (FDA) priority review voucher (PRV) intended for
vadadustat, subject to contractual agreements with our partner Akebia
In March 2020, Vifor Pharma initiated the sale process for OM Pharma
UPDATED FINANCIAL GUIDANCE 2020
In 2020, net sales are expected to grow in the range of 5% at constant
exchange rates, reported EBITDA is expected to grow in the range of
20%.1
FINANCIAL PERFORMANCE
In million CHF
H1 2020
H1 2019
Change in %
Net sales
922.5
913.3
1.0%
EBITDA
305.1
254.6
19.8%
Net profit after minorities
67.9
65.2
4.3%
Core earnings per share (in CHF)
2.66
2.11
26.1%
For further details, please see the Vifor Pharma Group 2020 Half-year Report (PDF) at www.viforpharma.com.
KEY PROFIT AND LOSS FIGURES
Vifor
Pharma Group net sales increased by 1.0% to CHF 922.5 million compared
to the prior period, or 4.3% on a constant currency basis, despite
impact from COVID-19 restrictions. EBITDA increased to CHF 305.1 million
compared to CHF 254.6 million in the prior period, an increase of
19.8%. Growth was primarily driven by the increase in other income
combined with cost containment measures to offset the COVID-19 impact on
net sales.
Other income was CHF 43.0 million compared with CHF
20.4 million in the prior period. This was primarily due to higher
income from partnering activities as well as a divestment of non-core
products in Spain.
Cost of sales amounted to CHF 375.9 million
compared to CHF 373.3 million in the prior period. This resulted in a
gross profit margin of 61.1% compared to 60.0% in H1 2019, the increase
is primarily due to the other income contribution.
Marketing and
distribution expenses amounted to CHF 202.3 million, down 7.4% from the
prior period. The additional investments in pre-launch activities of our
pipeline products were more than offset by lower cost due to COVID-19
restrictions.
Investments in R&D amounted to CHF 156.2
million compared to CHF 109.4 million in the prior period. The increase
was attributable to the impairment of the CCX140 intangible asset of CHF
56.2 million.
General and administration expenses amounted to
CHF 96.0 million compared to CHF 83.8 million in the prior period. The
increase was driven by growth across support areas including
strengthening of legal and intellectual property capabilities as well as
enhancement of technology and systems.
Core earnings per share
amounted to CHF 2.66 in H1 2020, an increase of 26.1% compared to CHF
2.11 in H1 2019. The increase reflects the strong EBITDA growth in H1
2020. Core earnings are defined as reported earnings after minorities
adjusted for proportionate amortisation and impairment of intangible
assets of CHF 104.9 million in H1 2020 (H1 2019: CHF 71.9 million).
CASH FLOWS
Cash
flow from operating activities amounted to CHF +172.6 million compared
to CHF +197.9 million in the prior period. The decrease is due to
investments in net working capital in H1 2020.
Cash flow from
investing activities amounted to CHF -152.8 million and is mainly due to
the purchase of the Priority Review Voucher of CHF -107.7 million as
well as upfront and milestone payments for in-licensing agreements of
CHF -19.6 million related to Mircera®.
Cash flow from financing
activities amounted to CHF -254.0 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 shareholders of Vifor Pharma.
FINANCIAL POSITION
Goodwill
and intangible assets amounted to CHF 2,557.1 million at the end of H1
2020 compared to CHF 2,584.5 million at the end of 2019, representing
52.2% of total assets (end of 2019: 52.4%).
Net debt was CHF
232.9 million resulting in a net-debt-to-EBITDA ratio of 0.39 at the end
of H1 2020. This is compared to net cash position of CHF 5.7 million at
the end of 2019. The increase in net debt is mainly due to the dividend
payment of CHF 219.6 million in H1 2020.
With CHF 3,672.8
million of shareholders’ equity, Vifor Pharma Group continues to have a
strong equity ratio of 75.0% at the end of H1 2020 compared to 75.7% at
the end of 2019.
2020 OUTLOOK
Market Access
Veltassa® partnering in China
Ferinject® launch in Japan expected in H2 2020
Filing of avacopan for treatment of ANCA-associated vasculitis in Europe expected before end of 2020
Filing of CR845 in the US expected in H2 2020, followed by the application in Europe
Clinical trials
AFFIRM-AHF readout expected by end of 2020
Avacopan phase-II ACCOLADE in C3 Glomerulopathy study readout
Business development
At least one additional in-licensing, product acquisition or corporate transaction is expected before the end of 2020.
Live conference call and webcast
A live webcast and conference call will be held on the 6 of August 2020 at 2:00 pm (CET).
Access to live webcast → link
Access
to conference call → link (only if you want to participate via phone).
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Replay
A webcast replay (link) will be available shortly after the end of the live conference.
Vifor
Pharma Group is a global pharmaceuticals company. It aims to become the
global leader in iron deficiency, nephrology and cardio-renal
therapies. The company is the partner of choice for pharmaceuticals and
innovative patient-focused solutions. Vifor Pharma Group strives to help
patients around the world with severe and chronic diseases lead better,
healthier lives. The company develops, manufactures and markets
pharmaceutical products for precision patient care. Vifor Pharma Group
holds a leading position in all its core business activities and
consists of the following companies: Vifor Pharma; Vifor Fresenius
Medical Care Renal Pharma (a joint company with Fresenius Medical Care);
and OM Pharma. Vifor Pharma Group is headquartered in Switzerland, and
listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN:
CH0364749348). For more information, please visit viforpharma.com.
1 Subject to no worsening of the situation due to COVID-19.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200805005676/en/
Contacts
Media Relations
Nathalie Ponnier
Global Head of Corporate Communications
+41 79 957 96 73
media@viforpharma.com
Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com
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