Galenica 2012: Good sales performance with profits up on previous year, as predicted
Thursday, 17 January 2013, ↓ directly to download
Galenica increased its consolidated net sales by 3.4% to CHF 3,294.3 million in 2012. Currency effects played a minor role in 2012 compared to the previous year, although the negative impact of the strong Swiss franc continued. Group profit will increase for the 17th consecutive year.
Significant progress was made in key strategic projects:
Galenica confirms its net profit target for 2012 – both before and after minority interests – of above prior-year level.
2012 consolidated net sales of the Galenica Group (in million CHF)
Net sales with other segments
Net sales in the Pharma business sector rose by 8.4% to CHF 633.3 million. Adjusted for currency effects, the increase was 7.9%. Income from licensing fees from CellCept amounted to CHF 90.9 million (CHF 120.5 million in the previous year).
Vifor Pharma Rx
Strong international growth for Ferinject®. Ferinject® surpassed the CHF 100 million mark for the first time in 2012 by a large margin. Global sales growth of 48.4% to CHF 127.1 million was based on impressive growth rates in all countries. For example, the number of units sold (100 mg) increased
sharply in France (165%), as well as in the UK and Ireland (89%), the Netherlands (69%) and Germany (35%). The market launch of the product in the Belgium was also extremely successful and on a global scale, the number of units sold (100 mg) grew by 55% overall. Sales growth in the wellestablished
Swiss market was strong at 16.8%, clearly demonstrating once again the sustainable potential of Ferinject®.
Tapping the market potential of Ferinject® in all relevant therapeutic areas. Thanks to new marketing approvals in countries such as New Zealand, Turkey and Brazil and market launches in Peru and Luxembourg, Ferinject® is now available to patients in a number of additional countries. Progress
has also been made in advancing into therapeutic areas outside of dialysis. The new Guidelines of the European Society of Cardiology on acute and chronic heart failure confirm that iron therapy with ferric carboxymaltose, the active ingredient of Ferinject®, may be considered as a treatment for anaemic patients with chronic heart failure. Iron injections are also beneficial for anaemic patients with inflammatory bowel disease (IBD). For the first time, the guidelines on ulcerative colitis (Colitis ulcerosa) published in October 2012 by the European Crohn’s and Colitis Organisation (ECCO) focus specifically on the topic of anaemia and recommend treatment with intravenous iron. Finally, the PREFER study provides further scientific proof of the benefits of iron replacement therapy. It shows that Ferinject® leads to a statistically significant, clinically relevant reduction in symptoms of fatigue in iron deficient,non-anaemic women.
Injectafer® in the USA. Due to deficiencies in the manufacturing facility in Shirley, New York, the FDA notified the US partner Luitpold in July 2012 that the authorities would be withholding approval for Injectafer® (the brand name of Ferinject® in the USA) until these deficiencies were rectified. No additional clinical data were requested for the current application. Luitpold Pharmaceuticals has since been working closely with the FDA to resolve these deficiencies and is also preparing for the US launch of Injectafer®.
Venofer® maintains market position. Venofer® achieved sales of CHF 142.7 million in 2012 (-12.8%). Despite a negative price development in the USA, the launch of iron sucrose similars (ISS), pressure on prices in various markets, new intravenous original iron replacement products and substitution with Ferinject® in many countries, Venofer® was able to maintain its market leading position. The
new Venofer® vial formulation – which enables simpler, safer use – was approved in Europe in 2011 and had already been launched in a number of key countries. Further launches took place in Austria, Spain, Portugal, Sweden, Finland and Denmark in 2012.
Stability in other iron replacement products. Our other iron replacement products generated good results in the year under review. Sales amounted to CHF 66.0 million (+0.4%). The oral iron replacement product Maltofer® generated sales of CHF 50.8 million (-5.5%), to a large extent compensating for negative influences in the first six months in the second half of the year. At the end of 2012, Vifor Pharma also signed an exclusive agreement with China Medical System Holdings Ltd. for the registration and distribution of Maltofer® and Uro-Vaxom® in China.
Sales of other Vifor Pharma prescription products, which are mainly sold in Switzerland and Spain, rose 48.5% to CHF 70.3 million. This growth is partly attributable to the acquisition of the Primary Care business and various in-licensed products from Spanish company Grupo Uriach at the end of 2011.
First regulatory filings for PA21 submitted on schedule. The phase III trials for PA21, the novel iron-based phosphate binder, are complete. They confirm that PA21 is well tolerated and as effective as Sevelamer. The approval dossier for Europe was submitted to the European Medicines Agency (EMA) at the end of 2012 while the dossier for Singapore was submitted at the beginning of 2013.
Other regulatory filings are in the process of being finalised, in particular for the USA and Switzerland.Preparations for the launch and marketing with the partner Fresenius Medical Care are on schedule.
Successful inspections. Under the system of periodic audits and product pre-approvals, the St. Gallen, Geneva and Villars-sur-Glâne sites each underwent successful inspections by Swissmedic. St. Gallen and Villars-sur-Glâne were also successfully inspected by the US Food and Drug Administration (FDA).
Infectious diseases / OTX
Sales of the four leading products in the Infectious Diseases / OTX franchise posted pleasing growth overall, in particular Doxium® (CHF 30.8 million, +17.9%), Uro-Vaxom® (CHF 14.9 million, +16.7%) and Dicynone® (CHF 18.0 million, +7.5%). Broncho-Vaxom® sales were impacted by de-stocking in the first six months but experienced a clear upward trend in the second half (CHF 43.3 million, -9.4%).
Vifor Pharma Consumer Healthcare
Following a difficult start to the year, business improved in the second half, largely thanks to Vifor Pharma’s key markets. Sales of OTC products in Switzerland amounted to CHF 53.0 million (-3.7%). This downward trend is largely attributable to optimisation of the product range to exclude products that were no longer part of the core business, a declining market (-0.7%) and the mild winter.
Third-party manufacturing increased year-on-year by 13.5% to CHF 29.5 million. BG-12 production at the Vifor Pharma site in Villars-sur-Glâne successfully passed an FDA inspection. Production of this new multiple sclerosis drug from Biogen Idec offers interesting growth opportunities.
Vifor Pharma Consumer Healthcare exports grew by 4% to CHF 25.4 million. Perskindol® posted the best performance with double-digit international sales growth. Otalgan® and Triofan® also recorded considerable growth.
The Logistics business sector posted stable sales; despite price reductions, sales remained slightly above the prior-year level at CHF 2,102.3 million (+1.0%).
Customers reward market performance. Thanks in part to the new, rapid picking lines, Galexis can ensure on-schedule delivery of all available medications within just a few hours throughout Switzerland. One specialised Galexis service that was much in demand in the year under review was support for pharmaceutical partners in supplying drugs for clinical studies. Alloga continued to successfully press ahead with the launch of the new coolbox. It had been introduced to 85% of customers by the end of 2012. Over 4,000 are now in circulation.
The good results achieved by the Retail business sector in the second half of the year reinforced those of the first half. Sales increased by 6.4% to CHF 1,189.2 million (excluding Coop Vitality), with like-for-like growth of the pharmacies accounting for 3.0%. Given continuing pricing pressure, the general decline in retail sales and market development of +0.8%,this is a remarkable performance to which all formats and regions contributed. Growth was sustained by further expansion, high-priced medications from MediService’s Pharma Care business unit and increasing volumes of prescriptions in the pharmacies.
Expansion of the pharmacy network. In total, the GaleniCare pharmacy network expanded by 11 stores to 300 own pharmacies and comprised 467 points of sale including Amavita and Winconcept partner pharmacies at the end of 2012. Winconcept also gained six new partners, thereby expanding to a total of 153 partner pharmacies.
Following rapid growth in recent years, Amavita harmonised its product range and defined a core range for the various formats and pharmacy sizes. The reorganised pharmacies are showing a marked improvement in sales. Two jubilees and one other milestone were also celebrated: the 40th anniversary of Sun Store, the 15th anniversary of MediService and the opening of the 50th Coop Vitality pharmacy. Sun Store customers were able to take advantage of many special offers and competitions during the anniversary year, including the weekly “Sunny Monday” special promotion, which was so successful that it will be continued in 2013.
The HealthCare Information business sector generated sales of CHF 47.1 million (-1.3%) in 2012. Due to the new regulations governing publication of drug information, the Swiss Drug Compendium (Arzneimittel-Kompendium der Schweiz®) saw a decline in sales, as expected. This was offset almost
in full by further roll-outs of TriaPharm®.
New drug information publication platform. Documed won the European WTO tender from Swissmedic in 2012 and was thus awarded the contract to develop a new regulatory drug information publication platform (Arzneimittelinformation Publikationsplattform Swissmedic AIPS), which became operational on 1 January 2013. All data links and products that are supplementary to the legal publication requirements will continue to be offered and invoiced according to cost. The Competition Commission (COMCO) launched an investigation into HCI Solutions, Documed and e-mediat regarding the
commercialisation of electronic drug information in December 2012. Although these companies have a strong market position, Galenica is not aware of any abuse of this position and hopes that the situation will be clarified shortly.
With regard to software, HCI Solutions launched a new, more user-friendly generation of TriaPharm® software for cash registers in nearly all Amavita pharmacies. Following this successful implementation, a start was made on installing the software in Sun Store pharmacies.
Dates for the diary
The Galenica Group will announce the results of the 2012 financial year on 12 March 2013. The Annual General Meeting will be held on 2 May 2013 in Bern.
Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).
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Head of Corporate Communications