Jefferies 2016 Healthcare Conference. June 8, 2016

Transcription

1 Jefferies 2016 Healthcare Conference June 8, 2016

2 Safe Harbor This presentation contains forward looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are subject to risks and uncertainties which may cause our plans to change or actual results to differ materially from those anticipated. In particular, unforeseen events outside of our control may adversely impact future results. Additional information concerning these factors is discussed in our reports filed with the Securities and Exchange Commission including recent Form 8-Ks, our most recent Annual Report on Form 10K and our most recent Quarterly report on Form 10Q. The forward looking statements in this presentation reflect management s current views and may become obsolete as a result of new information, future events or otherwise. We may not update such forward looking statements to reflect a change of events or circumstances that occur after the date hereof, except as required by law. The industry and market data contained in this presentation are based on management s own estimates, independent publications, government publications, reports by market research firms or other published independent sources, and, in each case, are believed by management to be reasonable estimates. Although we believe these sources are reliable, we have not independently verified the information. 2

3 Leading Innovator in Bioprocessing Repligen is a pure-play innovator and manufacturer of high-value products that enable efficiencies in the production of biologics The Repligen brand represents: Best-in-class technology to address modern bioproduction needs A premium customer experience: service, quality and technical expertise We are building our business through: Organic growth Strategic acquisitions New product innovation and product line extensions Strength of the biologics commercial market and clinical pipeline 3

4 Strong Execution in 2016 year-to-date Renewed key long-term supply agreements for core Protein A ligands business Executed on strategic acquisition of Atoll GmBH on April 1 to broaden our fast-growing pre-packed chromatography line Raised $111M through convertible bond offering in May Recorded Q1 product revenue of $25.1M, up 21% year-over-year 4

5 What Makes Repligen Unique? Leader in Protein A Most of the world s monoclonal antibodies (mabs) are purified on Protein A ligands manufactured by Repligen Technology and market leadership Balanced, diversified portfolio Chromatography Customer first Custom solutions Cell Culture Filtration Systems Protein A Ligands Expanding global presence Multiple manufacturing sites, 190 employees Revenue: $83.5M in 2015 Bioprocessing expertise and focus 20 of the top biopharmaceutical companies use Repligen products 5

6 Strong Revenue Growth & Diversification Expanding Product Revenue and Gross Profit Margin Upstream Cell Culture Downstream Chromatography Downstream Protein A Ligands Upstream Cell Culture Downstream Chromatography Upstream Filtration Downstream Protein A Ligands 2012 $42M Sales 40% gross margin 2016 guidance $98M-$102M Sales 57%-59% gross margin 6

7 Recent news: Atoll Acquisition Acquired Atoll GmBH $9.1 million cash and 538,700 shares of Repligen stock; total upfront = $22.5 million Deal includes future contingent payments of 1 million based on defined revenue target for 2016 Integration expected to be completedby year end 2016 Expected to add $3.0-$3.5 million in revenue in 2016 (remaining 9 months) Expected to be breakeven on adjusted EPS in 2016, in 2017 accretive 7

8 Pre-packed leadership and EU base Repligen Acquires Atoll GmBH - Broadens portfolio, expands customer base and increases capabilities in growing pre-packed chromatography column market - Increases capabilities in fastgrowing segment WALTHAM, MA April 4, 2016 Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced that it has acquired Atoll GmBH ( Atoll ) of Weingarten, Germany, an innovator and manufacturer of MediaScout pre-packed chromatography columns used in process development and clinical manufacturing of biologic drugs. The acquisition of Atoll expands Repligen s pre-packed column chromatography portfolio into high throughput process development screening, complementing the Company s existing strength in clinical production-scale columns. The combined offering will provide bioprocessing customers with breadth and flexibility in choosing column size, chromatography media and packed bed formats. Expands column portfolio into screening and sample prep (process development) Leverages our investment in the commercial organization Expands customer base and provides EU operations center 8

9 The Bioprocessing & Biologics Market

10 Global Commercial mab Market Global Revenue, $ Billions $100.0 $90.0 $80.0 $70.0 $60.0 $50.0 $40.0 $30.0 $20.0 $10.0 $0.0 $79.2 $71.8 $62.1 $ $ Other Cimzia Yervoy Actemra Perjeta Orencia Synagis Simponi Xolair Erbitux Tysabri Stelara Soliris Prolia/Xgeva Eylea Herceptin Avastin Rituxan Enbrel Remicade Humira Monoclonal-based therapeutics are the dominant form of biologic drug Mature mab sales continue to grow with new indications and drug combinations >55 marketed mabs* *Includes biologics that use a mab manufacturing process Chart source: Company 10-Ks, internal tracker 10

11 mab Approvals on the Rise 10 Robust pipeline to sustain strong mab market growth 9 8 Fusion Proteins mabs A record 9 mabs were approved by U.S. FDA mabs approved by FDA year-to-date in 2016* The large majority of mabs are made using products manufactured by Repligen * As of April 16, 2016 Number of FDA approvals (YTD) Chart does not include label expansions 11

12 Biosimilar programs moving to late stage Analysts estimate the biosimilars market will reach $5B-$10B by %-10% of biologic drug sales are expected to be biosimilars by 2020 No. biosimilar mab programs Ph. 3 Ph. 3 Ph. 3 Ph. 3 Filed U.S. Ph. 3 Ph. 3 Ph, 3 Ph. 3 Ph. 3 Approved Ph. 3 Ph. 3 Filed U.S. Ph. 3 Ph. 3 Ph. 3 Ph. 3 Amgen Pfizer Merck Biogen Novartis Blockbuster reference mabs with patent expirations : Erbitux Herceptin Avastin Rituxan Enbrel Remicade Humira The top targeted biologics are monoclonal antibodies Combined global sales for these 6 mabs exceeded $50B in Example only. Not inclusive of all biopharma companies with biosimilar mab programs Sources: Company websites, ReportsnReports ($10B), GaBi Online ($6B)

13 Our Bioprocessing Products

14 Bioprocessing: An Attractive Market Biologics market growing at 8%-10% per year Increasing need for more flexible and efficient manufacturing driven by healthcare cost pressures and market globalization Sticky products with high barriers to entry - Risk and cost to change established biomanufacturing processes Future growth independent of the clinical or commercial success of any single drug candidate 14

15 Repligen s Direct Product Portfolio* Optimizing process efficiency and process economics Upstream Downstream Analytics Market leader in perfusion Enables continuous processing 2016: single-use launch as alternative to stainless steel,new applications, expansion in Asia Up to 200 times more potent than insulin In multiple commercial processes 2016: integration with MilliporeSigma, market seeding Market leader in prepacked columns Most flexible in resin choice and size Multi-site adoption and expansion into large pharma 2016: integration of Atoll (line expansion), new manufacturing suites to decrease lead times Cost-effective Protein A resins In several commercial processes, expanding pipeline of Phase 1-3 processes 2016: AsiaPac uptake Fast, reliable, and reproducible quantitation of leached Protein A, and LONG R 3 IGF-I 15 *Not shown above are Protein A ligands, which are sold through long term supply agreements

16 4 Product Franchises in a $700-$800M Addressable Market Products Market Growth Drivers Downstream Upstream Cell culture Growth Factors Cell retention Filtration devices Chromatography Protein A LONG R 3 IGF-1: $75-$80M market, share ~15% Displacing insulin XCell ATF System: $125-$150M market, share 10%-15%, displacing centrifugation OPUS pre-packed columns: ~$165M clinical market, ~30% penetrated, share >30% MediaScout pre-packed columns Protein A resins, ELISA Kits $350-$400M resin & ligand market Global leader in ligand manufacture Smaller player in Protein A resins Clinical to commercial convert LT growth 10%-15% XCell ATF Single-use (2016) New applications LT growth 10%-15% OPUS process-scale displacing self-packed glass MediaScout bench- and pilot scale LT growth 20%+ New mab approvals, market expansion, biosimilars LT growth 10%+ 16 = Direct-to-customer sales or distributor co-promote = Value add reseller

17 Expanding Global Presence Manufacturing Sites Waltham, MA, USA Lund, Sweden Weingarten, Germany Direct Sales Field Applications and Service Specialists Distributor 17

18 Growth Drivers & Financial Overview

19 Bioprocessing Growth Drivers Organic revenue growth Line extensions 10%-15% LT Margin improvement Acquisitions GM: Capacity utilization, yields OM: Leverage investments in systems and SG&A Same customer base, call points Upstream-to-downstream space Improve cost and/or operational structure 19

20 Financial Snapshot ($s in MILLIONS) Line extensions +24%-29% Guidance* Product Revenue Growth 27% 38% 17%-22% 10%-15% organic CAGR Product Gross Margin 10%-15% L-T 53.6% 57.8% 57%-59% 60% margin Same customer base, call points Up- to-downstream space Improvement opportunities Long-term goal Product Revenue $60.4 $83.5 $98-$102 $200-$250 by 2020 Product Gross Profit $32.4 $48.3 GAAP Income from Operations $10.7 $13.8 $18-$20 20%-25% margin Non-GAAP Adjusted Income from Operations $10.5 $17.8 $21.5-$23.5 GAAP Net Income $8.2M $9.3M $12-$14 Non-GAAP Adjusted Net Income $7.9M $13.4M $15.5-$17.5 GAAP Earnings Per Share (EPS) diluted $0.25 $0.28 $0.35-$0.41 Non-GAAP Adjusted EPS - diluted $0.24 $0.40 $0.45-$ M shares out (33.5M fully diluted), cash $71M at 3/31/ Guidance is as of May 5 earnings call. This does NOT include impact of subsequent capital raise, potential additional Refine contingent consideration in range of $2.25M - $3.55M, or potential reversal of $2.0 contingent consideration accrued in Q See GAAP to Non-GAAP reconciliation tables in Appendix

21 Well Positioned for Growth Many opportunities for growth driven by strength of market for biological drugs Brand leadership position; Repligen name represents best-in-class technology, premier customer experience Solid internal foundation for growth via infrastructure, innovation, strategic acquisition Strong financial position to invest in future growth Prepared to execute on goal to build a $200-$250 million global company by

22 Contact: Sondra Newman Sr. Director Investor Relations

23 Appendix: Reconciliation Tables

24 Reconciliation Table: Income from Operations Year ended December 31, 2015 Line extensions +24%-29% %-15% L-T Same customer base, call points Up- to-downstream space Improvement opportunities Appendix 1

25 Reconciliation Table: Net Income Year ended December 31, 2015 Line extensions +24%-29% %-15% L-T Same customer base, call points Up- to-downstream space Improvement opportunities Appendix 2

26 Reconciliation Table: Net Income per Share Year ended December 31, 2015 Line extensions +24%-29% %-15% L-T Same customer base, call points Up- to-downstream space Improvement opportunities Appendix 3