Net sales up 3.7% at constant exchange rates (CER), despite significant impact of COVID-19
Continued strong increase in EBITDA by 29.4% at CER, owing to a mix of one-time and sustainable cost measures
Ferinject / Injectafer sales showed rapid improvements in early H2 2020 following the loosening of COVID-19 restrictions, indicating return to growth in 2021 when lockdown measures begin to ease
Nephrology portfolio strengthened by expanded US difelikefalin agreement, license for ANG-3777 and EU regulatory submission of avacopan
Veltassa net sales impacted by market access headwinds and reduced promotion to nephrologists as a result of COVID-19 restrictions
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 rate2

ST GALLEN, Switzerland--(BUSINESS WIRE)--Regulatory News:

Vifor Pharma Group reported stable net sales and a continued strong increase in profitability in 2020, despite challenges to patient access from COVID-19 and the impact of a much stronger Swiss franc against the US dollar.

FINANCIAL PERFORMANCE: CONTINUED PROFITABLE GROWTH AT CER

• Reported net sales of CHF 1,705.6 million, down 1.1%, up 3.7% at CER
• Reported EBITDA of CHF 575.8 million, up 18.7% (up 29.4% at CER and 35.7% by also excluding the 2019 one-off IAS19 income)
• Other income increased significantly due to upfront and milestone payments from partnering activities and the disposal of non-core products
• Gross profit margin of 61.1%, up 0.9 percentage points driven by the higher contribution from other income
• Net profit after minorities of CHF 359.6 million, driven by the post-tax gain on sale of OM Pharma of CHF 190.6 million
• Core earnings per share3 from continuing operations of CHF 4.99, up 28.7%
• Strong balance sheet with a net cash position of CHF 190.6 million and an equity ratio of 77.1%

Commenting on the full year results, Stefan Schulze, CEO of Vifor Pharma Group, said: “Resilience and adaptability are the words that summarize the performance of Vifor Pharma in 2020. Our employees and partners have faced the challenges of COVID-19 with determination and flexibility as we continued to ensure our therapies reach patients. Patient access to treatments such as i.v. iron infusions has been closely correlated with the intensity of lockdowns, and direct contacts with physicians have been regularly postponed. Against this backdrop, and despite the impact of a much stronger Swiss franc against the US dollar, our profitability continued to increase strongly, helped by disciplined cost control and the strength of our growing nephrology portfolio. Considering the current outlook on the COVID-19 situation and the fact that our key products have shown a quick return to strong growth as lockdown measures were eased in 2020, we have a high level of confidence that we return to growth in 2021 once restrictions are eased. Adding our pipeline of innovative nephrology treatments on track for expected approvals in 2021 and 2022, continuing expansion 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 optimism.”

FERINJECT®/ INJECTAFER®: DEMAND INFLUENCED BY LOCKDOWN MEASURES

• Global in-market sales: CHF 1,005 million, up 0.1% and 49.5% share in the i.v. iron segment of the iron market4 by value in 20205.
• Net sales of CHF 552.2 million, a decrease of 1.6%, an increase of 3.0% at CER.
• Improvements in Q3 in line with the easing of COVID-19 restrictions and better patient access to infusions, followed by a slowdown towards year end as many countries started reintroducing restrictions. Overall utilization of i.v. iron has been highly correlated with intensity of lockdown measures, with recovery to pre-COVID-19 growth levels expected once COVID-19 restrictions are lifted.
• In the US, our partner American Regent, a Daiichi Sankyo Group company, recorded net sales for Injectafer® of USD 415.5 million in 2020, a decline of 6.6% compared to prior year. This was due to federal and state lockdown restrictions and limitations on infusion procedures caused by the pandemic. As a result, Vifor Pharma posted net sales of CHF 138.3 million, down 8.2% or 2.8% at CER.
• Results from the AFFIRM-AHF clinical trial in heart failure reported significant reduction in hospital readmissions due to heart failure among patients treated with Ferinject® compared to placebo. After 52 weeks, patients were 26% less likely to be readmitted to hospital for heart failure compared to placebo after one or two injections of Ferinject®. Overall, AFFIRM-AHF narrowly missed the 5% statistical significance on the primary composite endpoint of total cardiovascular death and heart failure re-hospitalization, but numerically reduced events by 21%. Prior to study completion, COVID-19 sensitivity analysis was pre-specified which excluded subjects reporting from the date of the outbreak in each country. Adjusted for COVID-19 impact the composite endpoint was more robust and significant.
• In Japan, our partner Zeria Pharmaceutical Co., Ltd. launched Ferinject® in September.

NEPHROLOGY PORTFOLIO SIGNIFICANTLY STRENGTHENED

• The Erythropoiesis-Stimulating Agent (ESA) portfolio decreased by 2.9% to CHF 524.3 million (up 2.5% at CER). Mircera® net sales amounted to CHF 478.4 million, down 8.6% from 2019 (down 3.6% at CER), affected by negative foreign exchange impacts and customer order patterns. Retacrit® net sales grew strongly in 2020 from CHF 16.4 million to CHF 45.8 million, due to higher demand from FKC clinics and the mid-sized and independent segment.
• Velphoro® net sales decreased by 2.2% to CHF 177.7 million (up 3.6% at CER), impacted by order patterns of our major customer in the US. Net of this impact, Velphoro® grew by 11.3% in 2020. In-market sales of Velphoro® strongly increased in 2020, with CHF 439.3 million or up 24.8%. Velphoro® launched in Canada and South Korea.
• Venofer® net sales increased by 2.9% to CHF 136.2 million (up 8.4% at CER), driven by growth in US and China.
• Vifor Pharma strengthened its nephrology portfolio during 2020. Key developments included:
• Avacopan - Vifor Fresenius Medical Care Renal Pharma (VFMCRP) announced acceptance for review in Europe of the Marketing Authorization Application for avacopan in patients with ANCA-associated vasculitis (AAV) in November. In December, ChemoCentryx, Inc. announced encouraging topline data from the phase-II ACCOLADE clinical study of avacopan in treatment of ultra-rare kidney disease Complement 3 Glomerulopathy (C3G). Following this positive result, VFMCRP plans to discuss registration pathways with regulators in the EU for C3G. Post balance sheet reporting, Kissei Pharmaceutical Co., Ltd. submitted the Japanese new drug application (NDA) for treatment of AAV in early March 2021.
• ANG-3777 - Vifor Pharma and Angion Biomedica signed a wordwide license agreement excluding Greater China in December for commercialization of ANG-3777 for the treatment of delayed graft function (DGF) and cardiac surgery-associated acute kidney injury (CSA-AKI), further expanding Vifor Pharma’s nephrology pipeline into transplantation and acute kidney injury.
• Difelikefalin (or Korsuva™) - Vifor Pharma and Cara Therapeutics signed a US license agreement in October to commercialize difelikefalin injection to non-Fresenius Medical Care dialysis clinics in the US, representing approximately 66% of the US market. Following this new agreement, Vifor Pharma have now commercialization rights for difelikefalin injection in the full US dialysis segment. Cara Therapeutics submitted the US NDA for treatment of moderate to severe CKD-associated pruritus (CDK-aP) in December. The FDA accepted the filing in February 2021. VFMCRP plans to file in Europe in H1 2021.
• Vadadustat - Positive results from the global phase-III INNO2VATE study evaluating safety and efficacy of vadadustat versus darbepoetin alfa for treatment of anaemia due to Chronic Kidney Disease (CKD) in adult patients on dialysis were reported by partner Akebia Therapeutics in May. Vadadustat achieved primary efficacy and cardiovascular safety endpoints.
• Rayaldee® - National marketing authorizations received in several European countries including Germany, Italy, Spain and Switzerland in 2020.

VELTASSA®: NEW PRESCRIPTIONS IMPACTED BY COVID-19 RESTRICTIONS

• Net sales of Veltassa® decreased by 10.6% (down 5.1% at CER) to CHF 118.3 million in 2020. In the US, net sales of Veltassa® amounted to CHF 106.7 million.
• The decrease in 2020 was due to the impact of the global COVID-19 pandemic, market access headwinds in the US and unfavorable exchange rates. The market growth remains below expectations.
• The European Medicines Agency approved important changes to the label in December. These included data from the phase-II AMBER clinical study demonstrating Veltassa® ability to enable RAAS (renin-angiotensin-aldosterone system) inhibitor treatment in patients with resistant hypertension and CKD.
• Veltassa® received reimbursement approval in Finland, Portugal and Switzerland in 2020, and formulary access was fully obtained in England, Wales and Northern Ireland. Our partner Otsuka Canada Pharmaceutical launched Veltassa® in Canada in May.
• In China, VFMCRP and Fresenius Kabi announced in November an agreement to develop, register and distribute Veltassa® for the treatment of hyperkalemia.

SALE OF OM PHARMA

• 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 Group the right to participate in 20% of the potential future value increase of the OM Pharma business.

1. FINANCIAL PERFORMANCE