SPEECH Date Speaker Subject 11 March 2014 David Ebsworth, CEO Galenica Group Strategic execution delivers solid performance in 2013 The spoken word is valid. STRATEGIC EXECUTION DELIVERS SOLID PERFORMANCE IN 2013 David Ebsworth CEO Galenica Group Media Conference, 11 March 2014 I am proud, ladies and gentlemen, to present the results of the Galenica Group for 2013. During this presentation you will see that our business performance has been solid thanks to the consistent strategic execution last year. Our employees demonstrated excellent work throughout 2013. Successful collaboration within the Group – Stability in the Leadership Team at Galenica 2 © Galenica Group 11.03.2014 The results we present today were achieved through a stable Leadership Team at Galenica and continued successful collaboration across the Group. I would particularly like to mention the great collaboration within the members of the Corporate Executive Committee, or DG. Galenica Ltd. Untermattweg 8 · P.O. Box · CH-3001 Bern Phone +41 58 852 85 17 · Fax +41 58 852 85 58 [email protected] · www.galenica.com The Galenica Group – excellence in the healthcare market Date 11 March 2014 Page 2/16 Subject Strategic execution delivers solid performance in 2013 Eight major strategic projects will drive success between 2012 - 2017 1. Vifor Fresenius Medical Care Renal Pharma: global leader 2. Injectafer® 3. Ferinject® 4. Velphoro®: USA, EU, Switzerland, Singapore (filed for registration) 5. Tecfidera®: Toll manufacturing for Biogen Idec 6. Strengthen network of sales affiliates 7. Retail: focus on processes, back office, efficiency, performance, locations 8. Logistics: strengthen our service offering to customers I N T E R N A T I O N A L C H 3 © Galenica Group 11.03.2014 In 2013 we made excellent progress with the vast majority of our eight key strategic projects. These projects will continue to impact our business over the next few years. I will explain the major achievements in 2013 later on. Motto 2013 – In tune with the customer 4 © Galenica Group 11.03.2014 The Motto 2013 was incorporated into our culture and we demonstrated it in daily life. Some examples of being in tune with the customer can be seen here and in the annual report. Date 11 March 2014 Page 3/16 Subject Strategic execution delivers solid performance in 2013 Solid performance in a challenging environment Galenica Group NET Sales Net sales 2013 in MCHF % prior year 3,359.4 + 2.0% 662.7 + 4.6% Logistics 2,118.2 + 0.8% Retail 1,245.7 + 4.8% 39.8 - 15.5% Pharma HealthCare Information Consolidation (707.0) 5 © Galenica Group 11.03.2014 You already know our sales numbers. Nevertheless the solid top line growth which was achieved in a challenging business environment is worth highlighting. The overall growth of 2.0% was driven mainly by our important Pharma and Retail sectors. What was the growth rate of the various parts of the Retail business? Retail – Net sales increase in all formats despite further price cuts Retail increased net sales by 4.8% vs. previous year. Sales like-for-like growth of 1.6%, slightly over market growth (+1.0%). Important efforts to increase customer traffic. Net sales % prior year Amavita + 5.3% Sun Store + 1.4% MediService + 9.9% Winconcept + 10.7% Coop Vitality + 5.7%* 6 © Galenica Group 11.03.2014 * Sales not consolidated This slide shows that the 4.8% growth was achieved with solid performance across all four formats, Amavita with 5.3%, Sunstore with 1.4%, CoopVitality with 5.7%, MediService – our specialty home healthcare and mail order pharmacy – with the growth of 9.9%. In the case of the pharmacy chains, this growth rate was a result of like-for-like growth and expansion activities. Date 11 March 2014 Page 4/16 Strategic execution delivers solid performance in 2013 Expansion and optimisation of pharmacy network contributes to 2013 growth 312 own pharmacies. 483 points of sale including Amavita and Winconcept partner pharmacies. Number of pharmacies and change vs. previous year: 104 (-2) 156 (+4) 1 © Galenica Group 11.03.2014 (incl. Amavita partner) 55 (+4) 160 (+7) 1 The pharmacy network was further expanded and optimised. We now have 312 stores in our own network, as well as another 171 partner pharmacies, an overall increase of 16 points of sales in the past year. Retail strategy designed to improve performance Physician Health insurances Customer Retail competence Leadership Pharmacy services Supplier Subject Process efficiency 8 © Galenica Group 11.03.2014 The Retail management team strengthened their focus across all major elements of the strategy: Pharmacy Services, Retail Competence, Process efficiency and Leadership effectiveness which resulted in an improvement of efficiency in each of our pharmacy formats as illustrated on the following slides. Date 11 March 2014 Page 5/16 Subject Strategic execution delivers solid performance in 2013 Major progress in 2013 with Retail projects Project Team Performance: Team involvement in goal setting, solution generation and monitoring progress. More time for customer service through greater back office efficiency. Pilot project Customer Feedback: Systematic customer surveys. Planned introduction of the system in all GaleniCare pharmacies. 9 © Galenica Group 11.03.2014 In 2013, the Retail team made major progress with a focussed project organisation to meet customer’s needs, identified through systematic surveys and turned into reality through projects such as Team Performance. Major progress in 2013 with Retail projects Project LoRe: Shelf pricing: leaner goods delivery processes and an increased transparency for customers. More efficient stock management. Projects PEP / Alterno: Standardisation of processes in Finance and HR. New IT-system for pharmacies for an electronic staff resource planning (PEP). 10 © Galenica Group 11.03.2014 The successful implementation of Project LoRe as well as project PEP/Alterno were major steps forward and help to manage the stock management as well as Human Resources and financial processes in a standardised way. Date 11 March 2014 Page 6/16 Subject Strategic execution delivers solid performance in 2013 Customer focus – Optimal care for the health and wellness of our customers Own brand offer continuously extended: 54 SKUs in both formats. Successful pilot project „quick allergy test” in Zurich. Introduction in all Amavita and Coop Vitality pharmacies in 2014. Polymedication checks: benefit for patients and healthcare system. More than 3,000 tests conducted. Category management project: Roll-out OTC 2014 in all Amavita pharmacies. 11 © Galenica Group 11.03.2014 In 2013, further initiatives such as quick allergy tests and polymedication checks were implemented to ensure the better care of the health and wellness of our customers. The own brand formats were continuously expanded. The rollout of OTC category management in all Amavita pharmacies in 2014 will further strengthen the portfolio. Responding to the customers’ needs Category management pilot project with category «oral hygiene». Tailor-made management and marketing offers for independent pharmacies. Consulting Services to improve product ranging. Expansion of service range in Pharma Care (new: haemophilia treatments). Implementation of guidelines «for good distribution practice for medicinal products for human use». 12 © Galenica Group 11.03.2014 MediService expanded its service range in Pharma Care in 2013 and other initiatives were implemented for Sun Store and Winconcept. Date 11 March 2014 Page 7/16 Subject Strategic execution delivers solid performance in 2013 Logistics – Stable net sales due to expansion of customer services 2,118.2 MCHF net sales + 0.8% prior year Acquisition of several new customers. Expansion of various special ranges to meet specific customer needs. Third-party logistics service: positive reaction in market. Customers and suppliers can delegate bulk and fine-distribution to Logistics. Project Coaxial: Standardisation of IT-Infrastructures into one data center in Niederbipp, reduced costs. % prior year* Alloga + 5.3% Galexis + 0.7% Unione - 1.1% *not consolidated 13 © Galenica Group 11.03.2014 Within Logistics we defended our market share in 2013 and achieved growth in both the Alloga prewholesale and the Galexis wholesale business whilst suffering in Unione, our Tessin based wholesale business. Customer acquisition worked well, we increased our productivity and the way we worked with our partners. Tailor-made Services for customers Acquisition of Medifilm: Leader in the field of unit dose packaging for medicines. Increase of compliance and safety with individual sachets. Successful introduction of a range of medical technology devices: offer with approx. 100 products at Euro prices for doctors. Trade brand programme G-Pharma: expansion of product range (over 100 products): own brand Retail, product line for Galexis, trade brands. 14 © Galenica Group 11.03.2014 Through the integration of Medifilm into the Logistics business sector, the range of services has been expanded. Additional medical technology devices were introduced at Euro prices and the product range of G-Pharma was expanded. Date 11 March 2014 Page 8/16 Subject Strategic execution delivers solid performance in 2013 Increase of efficiency through use of transport synergies Good collaboration within Logistics business sector in the area of transportation – an economically and ecologically efficient solution. Number of shared shipments - 2013 4'000 3'500 3'000 2'500 2'000 1'500 1'000 500 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 15 © Galenica Group 11.03.2014 Alloga already has implemented the new GDP guidelines to guarantee the cool chain in 2013. Their level of automation in 2013 was 31%. The implementation of the a new version of pharmacy software was a complete success at Unione. The sales force of Unione was expanded to serve our customers’ needs and provide additional services for distributors. A good example for collaboration is Galexis and Alloga working together to increase their efficiency through the use of transport synergies. HCI – Impact of changed market conditions observable Rollout TriaPharm® in Amavita and Sun Store pharmacies. Sales activities for TriaMed® intensified. The system allows the access to the patient’s medical history for all physicians involved in the patient’s treatment. Documed: over 80% of the pharma market uses our databases through the software “compendiumPORTAL”. e-mediat: ca. 150 software firms use the INDEX products in their applications. Over 300 hospitals are working with hospINDEX. Net sales 2012 in MCHF 2013 in MCHF HCI 47.1 39.8 16 © Galenica Group 11.03.2014 The Healthcare Information business continued to successfully enhance various clinical decision ® ® support systems, and expanded our presence with the TriaPharm and TriaMed software systems. 80% of the pharma market is now using the compendiumPORTAL which is a great achievement. Furthermore, the business of e-mediat was expanded. Date 11 March 2014 Page 9/16 Subject Strategic execution delivers solid performance in 2013 Stable ROS in Santé – Despite a very competitive environment ROS 2012 2013 Logistics 1.5% 1.5% Retail 5.1% 5.1% HCI 9.1% 10.2% 17 © Galenica Group 11.03.2014 As a result of this strong teamwork, the operational effectiveness and efficiency demonstrated by all Santé businesses, we have been able to maintain or improve in the return on sales across all three businesses. With 1.5% in Logistics and 5.1% in Retail our RoS can be considered strong in the European context. Vifor Pharma operates in a challenging environment internationally given the increased complexity of market access, governmental budget restrictions in healthcare, growing regulatory pressures and increased competition. Excellent progress made in all Vifor Pharma projects 2013 1. Vifor Fresenius Medical Care Renal Pharma: Partnership strengthened 2. Injectafer®: FDA approval 3. Ferinject®: Marketing Authorisation received in 15 further countries 4. Velphoro®: EU, Switzerland, Singapore (filed for registration) and FDA approval received 5. Tecfidera®: Toll manufacturing for Biogen Idec: Double-digit sales growth 6. Strengthen network of sales affiliates: Hospital sales force built in Italy I N T E R N A T I O N A L 18 © Galenica Group 11.03.2014 I am very proud of the achievement of the Vifor Pharma team when I look back at a successful 2013. The partnership with Vifor Fresenius Medical Care Renal Pharma was further strengthened, ® ® Injectafer and Velphoro were approved by the FDA, 15 new marketing authorisations for ® rd Ferinject were received, double-digit sales growth was possible in 3 party manufacturing given ® the Tecfidera launch and we strengthened further the network of our affiliates. Date 11 March 2014 Page 10/16 Subject Strategic execution delivers solid performance in 2013 Vifor Pharma – Solid growth of +4.6% vs. prior year! 2013 in MCHF ± % prior year 662.7 + 4.6% Rx 422.3 + 4.0% Infectious diseases/OTX 117.0 - 2.0% CHC International 27.7 + 9.2% CHC Switzerland 59.7 + 12.7% 3rd party manufacturing 36.0 + 22.1% Total Vifor Pharma Core Business 19 © Galenica Group 11.03.2014 Given this, a sales growth rate of 4.6% with a good growth in our core prescription business is worthy of note. The only business that struggled was our Infectious diseases/OTX franchise. Destocking at our partners continued to play a role. Ferinject® was growth driver of the iron franchise in 2013! 2013 ±% prior year ±% in volume in MCHF Ferinject® 158.2 + 24.5% Venofer® 128.8 - 9.8% + 37.3% - 2.5% Maltofer® 52.6 + 3.5% + 8.9% 20 © Galenica Group 11.03.2014 ® As you would expect, Ferinject was the growth driver within our iron franchise where we achieved ® a 37.3% volume growth. Our other iron products did well. Venofer declined by 2.5% in volume and ® 9.8% in value and I will return to this topic later. Maltofer was able to strengthen its market position. ® There were a number of factors impacting our growth of Ferinject of which one was the implementation of improved top down education. Date 11 March 2014 Page 11/16 Subject Strategic execution delivers solid performance in 2013 Ferinject® – FIND-CKD study will help improve patient care Over 600 patients from 20 countries participating in the 56 weeks trial. Study results: Better control of iron deficiency anaemia in non-dialysis-dependent chronic kidney disease (ND-CKD) patients. Ferinject® reduces the need for other anaemia management in this patient population: better patient care and costs reduction in the health care system. 21 © Galenica Group 11.03.2014 The FIND-CKD study is ground-breaking in terms of its scale and reflects the commitment of Vifor Pharma to grow our iron portfolio by expanding the areas of usage for iron therapies. It is the largest and longest study ever conducted in patients with ND-CKD to assess the efficacy and long term safety of intravenous iron for the treatment of iron deficiency anaemia − with over 600 patients from 20 countries participating in the 56 week trial. The results of the study demonstrate that ® Ferinject significantly prolongs the time until other anaemia management is needed in patients suffering from iron deficiency anaemia who have non-dialysis-dependent chronic kidney disease (ND-CKD). This is a significant finding because iron deficiency anaemia becomes more prevalent in patients suffering from ND-CKD as the disease progresses. Vifor Pharma is continuing to set the standard for innovative approaches to iron deficiency therapy, and this achievement is the latest example of our commitment to transforming the lives of patients around the world who can benefit from our therapies. Injectafer® was approved in July 2013 with a broad label 750mg iron / 15ml single use vial. 2 pivotal trials demonstrate clear differentiation for Injectafer® based on faster and higher haemoglobin increase compared to the existing intravenous standard of care or oral iron. Focus on Haematology / Oncology centres. Luitpold has launched Injectafer® in the US. C-code awarded of 1st January 2014. Price increase of 3% per 1st January 2014. 22 © Galenica Group 11.03.2014 ® Receiving US FDA approval of Injectafer in July was a major accomplishment: the product is the first non-dextran intravenous iron therapy to gain US FDA approval for the treatment of iron deficiency anaemia (IDA) in a broad group of patients, irrespective of the underlying origin. Our ® partner, Luitpold, launched Injectafer in the US market after receiving the approval, and we anticipate increased sales momentum in 2014. Date 11 March 2014 Page 12/16 Subject Strategic execution delivers solid performance in 2013 New partnership with Zeria Pharmaceutical for the development and commercialisation of Ferinject® for IDA in Japan Extensive experience of Zeria Pharmaceutical will drive the launch of Ferinject® in Japan. 23 © Galenica Group 11.03.2014 We announced an agreement with Zeria Pharmaceutical for the development and ® commercialisation of Ferinject for IDA in Japan. I am confident of benefitting from their extensive ® experience when we launch Ferinject in Japan – the world’s second largest pharmaceutical market. Ferinject® – Solid volume growth in key countries % in volume Ferinject® total + 37.3% Switzerland + 13.2% Germany + 15.9% France + 22.8% UK + 44.2% Spain + 20.5% 100mg equivalents 24 © Galenica Group 11.03.2014 ® In our sales affiliates, Ferinject demonstrated a solid volume growth compared to the previous year. Date 11 March 2014 Page 13/16 Subject Strategic execution delivers solid performance in 2013 Ferinject® – New launches will reinforce future growth 6 countries launched in 2013 1. Cyprus 2. Malta 3. Mexico 4. Pakistan 5. Turkey 6. United States 25 © Galenica Group 11.03.2014 Ferinject ® / Injectafer ® approved, not yet in the market Launched in 42 countries Approved in 58 countries ® We achieved notable geographic expansion of Ferinject , which is now available in 42 markets worldwide and registered in 58 countries. New launches will help to accelerate the global growth of ® Ferinject . Lifecycle management of Venofer® is ongoing ±% in CHF Venofer® sales - 9.8% USA - 13.0% Others - 6.7% Volume decline is decreasing. Impact of Ferinject® in selected markets. The new branding will help to fight for Venofer® in the Iron Sucrose Similars (ISS) environment. 1 © Galenica Group 11.03.2014 ® Our teams are providing strong life-cycle product management of Venofer , which continues to ® maintain leadership in many markets despite decline in volume and the impact of Ferinject in ® selected markets. The new branding and information will help to fight for Venofer in the Iron Sucrose Similars (ISS) environment. Date 11 March 2014 Page 14/16 Subject Strategic execution delivers solid performance in 2013 Infectious diseases/OTX – Good growth in IMS sales driven by emerging markets 2013 in MCHF ±% in LC* ±% in IMS BronchoVaxom® 47.6 + 9.5% + 14.3% Uro-Vaxom® 15.9 + 6.0% + 12.0% Doxium® 25.7 - 16.4% + 8.0% Dicynone® 17.0 - 5.6% + 1.0% * local currency 27 © Galenica Group 11.03.2014 In market growth (IMS) for all key Infectious diseases/OTX products in 2013 exceeded that of the reported ex-factory sales due to destocking partners. Velphoro® to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis US Food and Drug Administration (FDA) approval received in November 2013. Launch in the USA in March 2014. Regulatory processes are ongoing in EU, Switzerland and Singapore and decisions expected mid 2014. Marketing Authorisation Application was submitted to Australian TGA and procedure started 30th November 2013. Further submissions are under preparation. 28 © Galenica Group 11.03.2014 ® ® We made excellent progress with Velphoro in 2013. At the end of November, Velphoro (previously known as PA21) was approved in the US and the launch occurred early in March 2014. Other marketing authorisation applications are under review in Europe, Switzerland, Singapore and Australia. Launch preparations for these countries are ongoing and further submissions are under preparation. Date 11 March 2014 Page 15/16 Subject Strategic execution delivers solid performance in 2013 Vifor Pharma third-party manufacturing business – Production of Tecfidera® intensified Third-party manufacturing business: double digit sales growth. Tecfidera® has the potential to become the world's leading treatment for the treatment of relapsing-remitting multiple sclerosis. Approval in the USA 27th March 2013. European Commission approved Tecfidera® as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). 29 © Galenica Group 11.03.2014 I would like to highlight the double digit sales growth of our third-party manufacturing business. ® Tecfidera was approved in the USA last year and has recently been approved in Europe and it is ® expected to gain considerable market share. Tecfidera , manufactured at our site in Villars-surGlâne on behalf of Biogen Idec, further demonstrates that we are in tune with our customers and their needs. Continued strategic focus as basis for success in 2014 Accelerate growth with Ferinject®. Supporting the launch of Injectafer® in the USA with our partner Luitpold Pharmaceuticals, Inc. Working towards further approvals of Velphoro® and successful commercialisation with Vifor Fresenius Medical Care Renal Pharma. Continuing to strengthen our ID/OTX and OTC products. Increase volumes of third-party manufacturing. Optimising processes and extension of the range of services in Logistics. Optimising the product range and new services to increase customer loyalty and to attract new customers in Retail. 30 © Galenica Group 11.03.2014 We are on track with the vast majority of the key strategy projects, whether this be in Santé or Vifor Pharma. ® In 2014 we will retain our strategic focus on further growing Ferinject , further supporting the ® ® launch of Injectafer in the USA, working towards further approvals of Velphoro and its successful commercialisation as well as strengthening our ID/OTX and OTC franchise. In addition, we expect to expand production volumes in third-party manufacturing. We will continue to fine-tune our Logistics activities, optimise our product range and services in Retail to attract new customers and increase customer loyalty. In all areas of the Swiss business, my team and I will work closely together to achieve synergies between the various divisions. Date 11 March 2014 Page 16/16 Subject Strategic execution delivers solid performance in 2013 Motto 2014 – Our passion, customer satisfaction 31 © Galenica Group 11.03.2014 A key focus across Galenica is understanding our customers which is why we have decided to introduce the motto “Our passion, customer satisfaction” for 2014. We will demonstrate passion for strong performance in 2014 and this will help us to deliver solid results. Thank you for your attention.
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