Lotus - IR prez_20150514_FINAL
Transcription
Lotus - IR prez_20150514_FINAL
LOTUS BUILDING A PAN-REGIONAL LEADER May 2015 Page I 1 Safe Harbor Statement Except for historical information contained herein, the matters set forth in this presentation are forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward looking statements are not based on historical facts but rather on management’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward looking statements. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. Investors are cautioned not to place undue reliance on these forward looking statements, which are made as of the date of this presentation and we assume no obligation to update or revise any forward looking statements. Page I 2 Page I 2 COMPANY OVERVIEW Page I 3 Page I 3 COMPANY OVERVIEW Market Leader in the Highly Attractive Asia Pacific Generic Pharmaceutical Industry Pioneer in the Asia Pacific Generic Pharmaceutical Industry • • • • • • • 1 2 Research-based company focused on innovative development of difficult to make generic pharmaceuticals 63.4% owned by Alvogen, a specialty pharmaceutical company with global presence, focusing on developing, manufacturing and marketing of generic and OTC pharmaceuticals, as well as biosimilars #1 in Korea in terms of sales from anti-obesity drug, and strong presence in Taiwan for oncology and CNS generic drugs Strong Pipeline • Robust international pipeline: – 8 products for Japan in pipeline – 4 products for EU Asia scope in pipeline – 9 products filed in China – 10 products in pipeline / filed ANDA for US Current product portfolio comprises 250+ marketed products Strong Growth and Margin Robust pipeline focusing on oral oncology, high potency, and soft gel drugs Experienced in-house sales team with a strong emphasis on marketing, covering ~10,000 clinics, hospitals and pharmacies / drugstores in Asia Pacific 1 US FDA, EU EMA, and Japan PMDA approved manufacturing facility, 2 KGMP approved manufacturing facilities and R&D centers with 140+ generic drug submissions for past 4 years 20141 NT$ MM US$ MM2 Revenue 2,310 75 Gross Profit 1,191 39 Gross Margin 52 % 52 % Net Profit (31) (1) Normalized numbers. Please refer to p. 20 for details of normalization Based on USD / TWD FX rate of 30.918. Page I 4 Page I 4 COMPANY OVERVIEW Lotus History and Key Milestones Alvogen Became a Majority Shareholder of Lotus Lotus Acquired Alvogen’s Korea, Taiwan and India Businesses Aug 11 Dec 19 Lotus Acquired Dream Pharma Listed in GreTai Stock Exchange (1795.TT) First Product Launch in the US First Product Launch in Japan Founded in 1966 1966 Manufacturing Facility Obtained US FDA Approval Manufacturing Facility Obtained Japan PMDA Approval US FDA Compliance Inspection Passed Manufacturing Facility Obtained EU EMA Approval EU EMA Compliance Inspection Passed Page I 5 Page I 5 COMPANY OVERVIEW Shareholding Structure Alvogen Asia Pacific Holdings Ltd. 63.4% Lotus Pharmaceutical Co., Ltd. (Taiwan) 100.0% Alvogen Taiwan (Taiwan) 100.0% Alvogen Korea Ltd. (Korea) 82.5% Kunwha Pharmaceutical Co., Ltd. (Korea) 100.0% Dream Pharmaceutical Co., Ltd. (Korea) Note: as of March 31, 2015 98.0% Alvogen Pharma India Pvt Ltd. (India) 100.0% Norwich Clinical Services Pvt Ltd. (India) 100.0% Lotus International Pte. Ltd. (Singapore) 100.0% Lotus Tab, Ltd (UK) 100.0% 樂特仕生物科技諮詢 (上海)有限公司 (China) Lotus Pharmaceutical, HK Inc. 100.0% (HK) 美喬生技有限公司 (Taiwan) 100.0% Page I 6 Page I 6 COMPANY OVERVIEW Lotus and Alvogen Joining Forces Asia Pacific Hub with Dominant Market Leadership for Alvogen • • • Well-established market leadership in Taiwan and Korea, high entry barriers countries for multinational firms • • State-of-the-art manufacturing facility approved by US FDA, EU EMA, and Japan PMDA, accessible to highly regulated markets • Strong pipeline and capabilities in difficult-to-make generics focusing on oral oncology, high potency, and soft gel • Global platform with unparalleled market potential for Lotus • Solid management team with extensive industry experience as well as in-depth knowledge from multinational background Strong sales and profit growth since Company’s inception with sales and marketing network in more than 30 countries Solid US regulatory and IP capabilities Robust pipeline of more than 300 products globally Proven track record in M&A execution The combination of Lotus’ strategically important foothold in Taiwan and Korea markets and its growing US/ Japan/ China product pipeline and Alvogen’s strong geographic coverage in the US, Central and Eastern Europe and Asia is expected to generate significant opportunities to drive revenue growth, margin enhancement, and create further value for the two companies Page I 7 Page I 7 INVESTMENT HIGHLIGHTS Page I 8 Page I 8 INVESTMENT HIGHLIGHTS Investment Highlights 1 Well-positioned in Highly Attractive and Fast Growth Markets 2 Strong Sales Forces and Distribution Channels in Key Markets 3 High Growth via Organic Growth and Strategic M&As 4 Strong R&D and Solid Manufacturing Capabilities Delivering Top Quality Drugs 5 Broad Pipeline that Delivers Sustainable Growth 6 Solid Integration Capabilities and Management Team that Extract Synergies and Generate Value Page I 9 Page I 9 INVESTMENT HIGHLIGHTS Well-positioned in Highly Attractive and Fast Growth Markets in Asia… 5yr CAGR (%) Pharma Market Size (US$bn) Japan 107.0 China 98.8 2.1% Strong Presence in Korea and Taiwan • 9.9% Well-established presence in key markets of North Asia where strong growing economies, fast aging populations, high cultural and other entry barriers for multinational firms • India 16.7 11.6% Korea 15.8 3.7% • #1 in Korea in terms of sales from anti-obesity drug • Solid track record in Taiwan for oncology and CNS generics Indonesia 5.9 9.2% Taiwan 5.5 7.1% Thailand 4.5 7.3% Philippines 3.8 5.2% Strong market leadership in Korea and Taiwan Well-positioned to tap into other Asian markets Vietnam 3.3 13.9% Malaysia 2.2 11.5% Bangladesh 2.0 9.2% Hong Kong 1.6 8.0% Singapore 0.8 7.6% Source: BMI Research • • • Well-planned strategies for access to Japan and China • 8 products for Japan in pipeline • 9 products filed in China Leveraging existing production capabilities and commercial network through Alvogen’s platforms to further penetrate fast growing markets in South East Asia Aiming to tap into complementary markets in terms of product portfolio where mostly self-pay to fuel future growth Page I 10 Page I 10 INVESTMENT HIGHLIGHTS … As Well As US with Strong Sales Forces and Distribution Channels US - Direct access with strong pipeline leveraging US FDA approved manufacturing facility - 10 products in pipeline/ filed ANDA in the US - Product launch through Alvogen’s existing sales forces or partnership UK South Korea Shanghai Taiwan Indian Solid Market Position • • • Strong Brand Recognition • • • Presence Access Headquarter Branch Offices Partnership Covering a network of ~10,000 clinics, hospitals and pharmacies / drugstores with internal sales force in key markets Experienced sales force with product expertise Strong management team with executives and regional managers who have years of experience in the pharmaceutical industry Well recognized by clinics, hospitals and pharmacies / drugstores Effectively market and sell existing products and new products Foundation for cross-selling products targeting fast-growing / core therapeutic areas Page I 11 INVESTMENT HIGHLIGHTS High Growth via Organic Growth and Strategic M&As Organic Growth • • • Double digit growth per year Aggressive product launches across the APAC region – 26 products selected and roll out started into Korea and other Asian markets Gain further market share in existing and new markets • Alvogen, Lotus’ majority shareholder with robust M&A track record, is committed to supporting Lotus for future growth to achieve its target to become leading generic pharmaceutical player in APAC • M&A Strategies Solidify our leadership position in Asia Pacific generic pharmaceutical market and capture opportunities ahead of industry consolidation in the region • Strengthen product portfolio in our focused therapeutic areas – Acquire or invest in companies with generic pharmaceutical products or candidates that complement our existing product portfolio Selection Criteria • • Targets with strong generic drug submission capabilities or attractive products / candidates Targets’ products need to have strong market potential, potential synergies, and minimal overlap with existing product portfolio or pipeline • Opportunities with restructuring opportunities (balance sheet management, non core asset disposal opportunities) Page I 12 Page I 12 INVESTMENT HIGHLIGHTS Strong R&D and Solid Manufacturing Capabilities Delivering Top Quality Drugs Strong Development Capability • • • Integrated R&D Platform • In-house R&D capabilities Collaboration with industry leading companies and research institutions Integrated R&D Capabilities with a proven track record of successful innovations Systematically acquires and integrates targets with solid development and commercialization track record • Integrated capabilities spanning a widerange of therapeutic areas: – Strategically focus on oral oncology, high potency, and soft gel drugs Solid contract research organization in India: – Facilitates oncology studies – Quick patient enrollment Multiple Manufacturing Platforms • • • US FDA, EU EMA and Japan PMDA approved production facilities focusing on high potency and cytotoxic products Provides oncology contract manufacturing organization services to Japanese pharmaceutical companies Analytic process development for quality control and assurance Page I 13 Page I 13 INVESTMENT HIGHLIGHTS Broad Pipeline that Delivers Sustainable Growth • Biosimilars Lotus and Alvogen/AlvoTech signed distribution agreements for two key biosimilars currently under development by AlvoTech. • Lotus will market and distribute these biosimilars in the following APAC markets: Taiwan, China, Vietnam, South Korea, Thailand, Hong Kong, Philippines, Malaysia, Indonesia, Singapore and Myanmar Note: As of April 2015 Source of originator’s sales: IMS data Page I 14 Page I 14 INVESTMENT HIGHLIGHTS Solid Integration Capabilities and Management Team that Extract Synergies and Generate Value… Renaat Janssen CEO Lotus Previously Executive Director at PPD with more than 20 years experience in pharma industry Siegfried Gschliesser Deputy CEO Lotus and GM Taiwan Joined Alvogen in 2010 as regional head of Business development and the country manager for Taiwan David Young Regional CFO Previously CFO of SemiLEDs Corporation, (NASDAQ: LEDS), VP of sourcing, accounting and finance at Payless Shoesource, formally NYSE company Dr. Jon Valgeirsson, VP of R&D APAC Dr. Saral Thangam, CEO Norwich Clinical Services (CRO India) Jade Lee, Regional HR Director Sunny Chen, Regional Supply Chain Manager Dr. Chung R. Kim, Regional Quality Director Extensive Experience Senior management team has comprehensive experience up to 20 years in the pharmaceutical industries In-depth Knowledge Many have worked with leading global pharmaceutical companies. They bring extensive M&A and industry experience and in-depth knowledge Diversified Exptertise Experience and expertise range from research and development to manufacturing, sales, marketing and distribution Page I 15 Page I 15 INVESTMENT HIGHLIGHTS … With Strong Support from Board of Directors Charles Lin Chairman of BOD Robert Wessman Director • Founder of Lotus and has more than 30 years in pharmaceutical industry • Leads Lotus as a R&D-based Taiwanese company with manufacturing facilities approved by global FDAs • Chairman and CEO of Alvogen Group • Has grown Alvogen from a small US business into an international pharma with commercial operations in 34 countries and with 2,000 employees within 5 years Independent Directors Benjamin Ku Hui Wen Cheng Hjorleifur Palsson Partner at Cheng & Ku Law firm Professor at Taipei Medical University Previous EVP and CFO at Ossur hf., a listed company at NASDAQ OMX Copenhagen Directors Arni Hardarson Kevin Bain Thor Kristjansson Le Hong Chief Legal Counsel, Alvogen CFO, Alvogen EVP M&A, Alvogen VP, Lotus • Combined efforts from Lotus founding team as well as strong commitment from Alvogen Group with seamless cooperation • Nine distinguished members with an exceptional knowledge and experience in the related fields to guide the Company in all aspects Page I 16 Page I 16 GROWTH STRATEGIES Page I 17 Page I 17 STRATEGIES Lotus is Committed to Delivering Value-Driven Medicine 1 Further Develop Asia Pacific and US Generic Pharmaceutical Markets 2 Expand Product Portfolio through Strategic M&A 3 4 5 Expand Our Network of Sales and Marketing Personnel to Further Promote Our Products Unlock Value Through Realizing M&A Synergies Strong Support From Majority Shareholder - Alvogen 6 Page I 18 Page I 18 FINANCIAL HIGHLIGHTS Page I 19 Page I 19 FINANCIAL HIGHLIGHTS FY2014 Results Update Major adjustments include 1) costs related to early retirement programs of Kunwha for integration with Dream Pharma’s integrations of NT$266 million; 2) post-acquisition special bonus to Lotus’ employees of NT$12 million; 3) M&A-related costs including professional fees and transaction taxes of NT$39 million; 4) financial costs and losses related to the early redemption of Alvogen Korea’s CB of NT$113 million Page I 20 Page I 20 FINANCIAL HIGHLIGHTS 2015 YTD Monthly Sales Update Unit: NT$MM Key highlights 448 435 432 429 • • • 49 Jan 37 44 Feb Mar 2014 2015 52 • Robust January sales as the merger between Lotus and Alvogen’s key operations in Asia has been completed in 2014 with closing of Kunwha’s acquisition of Dream Pharma in December Contribution from Korean subsidiaries helped Lotus deliver a solid result in February of maintaining sales at a similar level with January sales despite both the Chinese New Year holidays in Taiwan and Korea Due to a substantial depreciation in the Korean Won against the New Taiwan Dollar from February to March, Lotus March consolidated sales in NT dollars slightly decreased. Excluding the FX impact however, the March result would in fact represented an increase with the integration of Dream Pharma going well Contributed by the synergies of co-promotional sales efforts between Kunwha and Dream Pharma and Lotus’ license fees related to a partnership for product sales into China, April sales achieved yet another record high with a solid MoM growth of 4.4% Apr Page I 21 Page I 21 2015 OUTLOOK Page I 22 Page I 22 2015 OUTLOOK 2015 Outlook Goals in 2015 • Successful integration of Dream Pharma and Kunwha in Korea • Further expand Lotus’ export business by launching more products in the US • Achieve solid profit and positive EPS Page I 23 Page I 23 APPENDIX Page I 24 Page I 24 APPENDIX Taiwan Pharma Market Overview Taiwan Market Overview • • • • • • • Taiwan Market Segmentation Taiwan is a ~US$5.5 billion pharma market. Fast aging population drives volume demand growth 11% 9% Taiwan has a National Health Insurance system covering 96% of the population under a one payer system Total Market ~US$5.5bn Payer is public; however, health administration is through private (non-profit) hospitals, clinics, and pharmacies. Hospitals are the dominate health care provider and are large behemoths offering both in and outpatient care 80% Hospitals Large concentration of the market in 21 medical centers which have around 35% of the total healthcare market Bad perception of local product quality prevented generic penetration into large medical centers so far so only multinational generics are able to get in as of now Regulatory approval timelines are between 12 to 18 months for generics products Taiwan has joined PIC/S from January 2014. Among the current 160 local manufacturers, only 70 have completed accreditation so far Hospitals 20% G.P. (Clinics) Drug Stores 40% 45% Generic 40% Patented G.P. (Clinics) 15% 20% 35% Drug stores 20% 65% Originator patent expired Page I 25 Page I 25 APPENDIX Korea Pharma Market Overview Korea Market Overview • • • • • • Korea Anti-obesity Drugs Market Outlook Korea is a ~US$15.8 billion pharma market and is expected to continuously grow due to aging population and increase in chronic diseases followed by growing demands for medical treatments • Korea’s medical diet market (including Korean medicine clinics, surgery, anti-obesity drugs) is estimated to be ~KRW1.6 trillion at the end of 2013, whereby the antiobesity drugs market accounts for ~9% Korea has a government funded health care system with complete coverage of the Korean population under one single payer (the NHIC) • With a growing perception that “obesity is an illness,” there is continued social focus on losing weight not only from external appearance perspective but also from pursuing a healthy life Further promotion of generic usage expected by the NHIC to reduce health care costs • Price erosion will be compensated by strong volume growth due to increased consumption by a fast aging population and further expansion of the health care coverage Generic regulatory approval times currently are around 6 to 9 months for locally produced products and 9 to 12 months for imported generics. It is expected the bias favoring local production will remain • Anti-obesity drugs possess a clear competitive advantage over its substitutes, as it maximizes the effect of weight loss within relatively shorter period of time at a lower cost (v.s. oriental medicine that requires consistent consumption and bariatric surgery with potential of high risk side effects) Consequently, overall anti-obesity drugs market is expected to account for a higher proportion of the domestic medical diet market The market is expected to be restructured led by top pharma companies with R&D and product capabilities Page I 26 Page I 26 APPENDIX Alvogen Today Alvogen Overview • • • • • • • An international privately-owned specialty pharmaceutical company focused on the development, manufacturing and marketing of generic pharmaceuticals, biosimilar and OTC products Alvogen Support • its target to become top-5 regional player in the APAC region by leading industry consolidation • Led by Chairman/CEO Robert Wessman and management team that previously worked at Delta / Actavis Group Robust product portfolio consists of a broad range of molecules for treating conditions in the fields of oncology, cardiology, respiratory, neurology and gastroenterology Deep experience in generic drug development with an strong track record of growth through organic growth and acquisitions Has manufacturing capabilities in US, Romania, Korea and Taiwan, and commercial operations in over 30 countries Geographic presence across the US, Central and Eastern Europe as well as Asia (Korea, Taiwan, China, Japan, India, etc.) Alvogen is committed to support Lotus for future growth to achieve Alvogen formally became a majority shareholder in Lotus in August 2014, currently owning approximately 63.4 % of outstanding shares following a private placement • As a part of the transaction, Lotus acquired 3 of Alvogen’s businesses in Asia: Korea, Taiwan and India • Securing distribution rights for biosimilar products currently under development by Alvogen’s sister company AlvoTech • Furthermore, Lotus’ subsidiary Kunwha acquired Dream Pharma in Korea in December 2014 • Co-development with Lotus with a focus on US difficult-to-make / high barrier products, i.e. oncology orals, hormones and soft gels Alvogen’s total revenue grew at a CAGR of 77% from 2009 to 2014 with 59% from organic growth Page I 27 Page I 27 APPENDIX Recent Acquisitions Kunwha Pharma – Acquired by Lotus in January, 2014 Key Milestone Business Mix • • • • Founded in 1958 Acquired by Alvogen in October, 2012 Prescription, OTC, medical device sales, export, consignment business 72 molecules (99 products) Production • Plant in Gongju: 46,893m2 Sales Network • 14 district sales organizations Employee / Office • • 257 employees in total as at the end of March 2015 – G&A (33). S&M(115), Plant incl. R&D (109) Headquartered in Seoul Page I 28 Page I 28 APPENDIX Recent Acquisitions (cont’d) Dream Pharma – Acquired by Lotus Subsidiary Kunwha in December, 2014 Key Milestone Product Mix • • • • • • • R&D • Established as the pharmaceutical division of Hanwha Corporation (March 1996) Changed the company name to DreamPharma Corporation (January 2005) Acquired Meditech Korea Pharm Co., Ltd. (September 2006) Anti-obesity drugs (56% of 2013 revenue): unrivalled #1 player in Korea with c.35% M/S Prescription (“Rx”) (37% of 2013 revenue): competitive advantages possessed in antibiotics, antifungal drug, hyperlipidemia treatment Possesses two OTC products and a closure of esthetique business completed in 2013 Leading R&D personnel: 79% with a postgraduate degree, 34% with a pharmaceutical career experience of at least 10 years Secured Korea’s New Drug Development Technical Award for Bonviva Plus (February 2014) Production • Sales Network • c.3,650 clinics and c.70 general hospitals in Korea Employee / Office • • 365 employees in total as at the end of March 2015 – G&A (34), R&D (39), S&M (179), Plant (113) Operates 8 branches and 2 sales offices nationwide Production and quality assurance of 106 drug items through in-house production (57 items) and outsourced production (49 items) compliant with KGMP (Korea Good Manufacturing Practice) Page I 29 Page I 29 APPENDIX Recent corporate action in Korea Merger between Kunwha Pharmaceutical and Dream Pharma Corporation • Since Dream Pharma is 100% owned by Kunwha Pharmaceutical, the merger can be completed as smallscale merger to Kunwha / short-form merger to Dream Pharma. Only board meeting of two entities are required unless 20% of shareholders notified its objection towards to merger between two entities • • Minority shareholders of Kunwha only account for 17.5% - no shareholders’ objection is expected Merger ratio – 1:0 (Kunwha/Dream) Merger timeline Date Board resolution for the execution of merger agreement March 17 2015 Completed Disclosure of Board resolution and relevant filing March 17 2015 Completed Execution of merger agreement March 18 2015 Completed Confirm the shareholders on shareholder registry April 1 2015 Completed Announcement of small scale merger April 1 2015 Completed Closure of shareholders’ registry April 2 - April 9 2015 Completed Receipt of notice from dissenting shareholders April 2 – April 16 2015 Completed Board resolution to approve the merger April 27 2015 Completed Dissenting creditor notification process April 28 – May 29 2015 Merger date June 1 2015 Page I 30 Page I 30