Going Solo Suits Vifor And Its Hopes For Two Blockbusters
Executive Summary
Enjoying its independence from Galenica, Switzerland’s third-largest pharmaceutical company believes that Ferinject and Veltassa will help it achieve sales of over CHF2bn by 2020.
After announcing its first full-year results as a standalone company, Vifor Pharma Group has laid out ambitious growth plans to more than double sales by 2020, driven by two potential blockbusters – its injectable iron product Ferinject (ferric carboxymaltose) and the hyperkalemia drug Veltassa (patiromer).
Vifor, Switzerland’s third-largest pharmaceutical company with 2,600 employees (1,200 of whom are based in its home country), has undergone major strategic and structural change in recent years. It started with the acquisition of the US firm Relypsa in 2016, which brought in Veltassa, and the spin-off from Galenica Sante, via an initial public offering which valued the latter at CHF1.96bn ($2.06bn), in April 2017. (Also see "The 'New' Vifor Pharma: Focused On Specialty Pharma" - Scrip, 10 Aug, 2017.)
The company has hit the ground running with 2017 sales beating market expectations, up 15.2% to CHF1.34bn, while earnings before interest, taxes, depreciation and amortization came in at CHF511.8m, a rise of 17.7% (excluding Veltassa launch costs of CHF231.5m).
Comfortably the biggest earner is Ferinject, the world’s best-selling intravenous (IV) iron therapy, which had sales of CHF435.6m last year, up 24.6%. Nearly half of that comes from Europe but on a conference call, chief commercial officer Dario Eklund confirmed that Daiichi Sankyo Co. Ltd., Vifor's partner for the product in the US (where it is called Injectafer) had identified the drug as a growth driver and quadrupled the sales force to more than 300 reps, helping to push sales up across the Atlantic by 35% to CHF91m. Partner Zeria Pharmaceutical Co. Ltd. is intensifying pre-launch activities in Japan for Ferinject, while a Phase III trial in China is progressing according to plan.
Vifor noted that recruitment would continue in the AFFIRM-AHF Phase IV trial of Ferinject for acute heart failure, the first study to investigate the effects of IV iron therapy on mortality and morbidity of AHF patients. The study will recruit about 1,100 patients with data readout expected in 2019.
As well as Ferinject, much of the focus for Vifor is on Veltassa, the first new treatment for elevated levels of potassium in the blood (ie hyperkalemia) in more than 50 years. Sales in the US were CHF 51.6m, up from CHF12.3m in 2016 and the company noted that payer coverage for Veltassa continued to improve.
The European Commission approved Veltassa in July 2017 and Vifor president Stefan Schulze noted on the call that it was already available through individual hospital funding in the UK, Norway and Denmark. A launch in the key German market is planned for the second quarter of 2018, followed by launches in Spain and Switzerland.
Chief financial officer Colin Bond said that Vifor hoped to unveil a partner in Japan for Veltassa before the end of the second quarter. The company believes the treatment will be a blockbuster but competition is on the horizon in the shape of AstraZeneca PLC's Lokelma (sodium zirconium cyclosilicate) – the drug, formerly known as ZS-9, had a previous positive opinion re-adopted by the European Medicines Agency's CHMP in January. (Also see "AstraZeneca's Lokelma To Join Veltassa In Hyperkalemia Sector" - Scrip, 31 Jan, 2018.)
Bond added that the company was looking to complete at least one in-licensing deal before the end of 2018. Its joint venture with Fresenius, Vifor Fresenius Medical Care Renal Pharma, has an exclusive agreement with Roche to commercialize the latter's anemia drug Mircera (methoxy polyethylene glycol-epoetin beta) in the US and the treatment brought in CHF339.9m in 2017, up 3.4%.
In terms of pipeline, avacopan is in Phase III for anti-neutrophil cytoplasmic auto-antibody-associated (ANCA) vasculitis and is being developed in collaboration with ChemoCentryx Inc.. If left untreated, 80% of patients diagnosed with the latter die within two years and Vifor is hoping for conditional marketing authorization approval late 2018/early 2019; avacopan is also being developed in patients with C3 glomerulopathy and atypical hemolytic uremic syndrome.
CCX140, also licensed from ChemoCentryx, is in late-stage trials for focal segmental glomerulosclerosis, a debilitating kidney disease. Vifor confirmed that it hoped to sign up a Japanese partner for the compound by the end of the year.
As for 2018, net sales are expected to grow by more than 10% at constant exchange rates, with EBITDA set to rise by more than 20%. Vifor has set itself a target in 2020 of sales exceeding CHF2bn and EBITDA reaching a high triple-digit level.