Leading Innovator in Molecular Diagnostics
Seegene Overview 2
회사개요 CEO/CTO: 천종윤대표이사 설립일 : 2000년 9월 15일 코스닥상장 : 2010년 9월 10일 시가총액 : 1,225십억원 (2015년8월31일기준 ) 임직원수 : 224명 (2015년 3월말기준 ) 본사 : 서울특별시송파구방이동 해외법인 : Genoa(Italy), Dubai(UAE), CA (US), Ontario(Canada) 해외지사 : Frankfurt(Germany) 사업분야 : 분자진단 (Molecular Diagnostics; MDx) 주요기술 : DPO (2005), TOCE (2011), MuDT (2014) 주요제품구성 분자진단시약적용장비 (OEM or re-sale) Nimbus (Hamilton) CFX96 (Bio-Rad) 호흡기질환검사제품 Re-sale 여성질환검사제품 STARlet (Hamilton) 기타감염성검사제품 OEM [ 유전자추출 ] [ 유전자증폭 ] 주요주주구성 주요주주 주식수 보유비중 CEO & related parties 9,187,503 34.9% Mirae Asset Global Fund 1,290,113 4.9% 국민연금 1,081,728 4.1% 자사주 140,575 0.5% 총계 26,230,924 100% 3
Founded 2005. DPO (Multiplex amplification technology) 2008. 미국주요검사센터에제품공급계약 2009. Randox( 영국 ) 사에기술이전 2010. KOSDAQ 상장 2011. TOCE (Multiplex Real-time PCR detection technology) 2012. mtoce (Multiplex mutation detection technology) 2012. Dupont Qualicon( 미국 ) 사에식품안전성검사분야기술이전 (TOCE ) 2013. BioMerieux( 프랑스 ) 사에식품안전성검사분야기술이전 (TOCE ) 2013. 일본제약사에동반진단분야기술이전 (mtoce ) 2014. MuDT (Next-generation qpcr) 2014. Beckman Coulter(Danaher, 미국 ) 사에 ODM 공급계약 2014. MuDT 적용첫호흡기신제품 (Allplex Respiratory panel1) 유럽출시 2015. 국내최초분자진단제품미국 FDA 510(k) 인증 (Anyplex II HSV 1/2 대상포진 ) 2015. 미국법인설립 (Seegene Technologies) 2015. Qiagen ( 독일 ) 사에 ODM 공급계약 2015. BD ( 미국 ) 사에 ODM 공급계약 2000 2005 2011 2012 2014 2015 4
연간매출액및 EBITDA ( 단위 : 십억원 ) Revenue EBITDA 39.4 51.7 59.0 64.4 Revenue 4-yr CAGR: 27.2% EBITDA 4-yr CAGR: 21.5% 24.6 7.7 12.0 14.6 17.3 16.8 2010 2011 2012 2013 2014(Consolidated) 제품별매출 (2014) 지역별매출 (2014) 기타분자진단검사시약 78% 국내 1% 수출 78% 22% 장비 21% 기타검사제품 8% 여성감염성질환검사제품 50% 기타 ( 아시아 / 중동 ) 15% 미주 27% 호흡기질환검사제품 20% 유럽 37% 5
해외네트워크강화전략 1. B2C ( 기존모델 ) 2. B2B 대리점 ODM 전세계 82 개대리점통해시약 / 장비공급 ( 국내 21 개, 해외 61 개대리점 ) 파트너 : 진단시약 ODM 공급 Seegene End-user Seegene 글로벌진단회사및제약회사 해외현지법인 기술이전 일부주요검사센터의경우시약 / 장비직접공급 현지해외법인통해글로벌네트워크강화중 ( 미국, 이탈리아, 중동 ) 파트너 : 식품안전성검사 동반진단 6
Beckman Coulter 사개요 Danaher(NYSE: DHR) 사에 2011 년인수 ($6.8bn) 제품구성 분자진단시약 ( 씨젠 ) 적용장비 ( 파트너사 ) 매출 (2014): $4.8bn 글로벌체외진단 (IVD) 시장 5 위 (M/S 8.4%) 글로벌혈액학분야 1 위 (M/S 34%) 글로벌면역화학분야 5위 (M/S 9%) 진단시장자동화시스템선두주자 ( 미국 M/S 50% 이상 ) 글로벌네트워크보유 - 전세계 33개자회사 - 총 231개국가, 64개사무소, 112개대리점 [ 동시다중감염성질환검사제품 ] VERIS 시스템의경쟁력분석 High multiplex qpcr - 실시간동시다중정량분석 전자동화시스템 (sample-to-answer) - 검체로딩, 유전자추출, 시약 mix, Real-time PCR 증폭및분석 Single sample random access - 검체가실험실에오는즉시하나씩바로검사가능 - 개별검체당다른 test menu 검사가능 Continuous access - 다른검체에대한검사진행중에도새로운검체로딩가능 다양한종류의검체사용가능 VERIS MDx System(Beckman Coulter) [ 전자동화검사시스템 ] 7
Qiagen 사개요 Qiasymphony system 매출 (2014): $1.3bn 분자진단세계점유 4 위 (M/S 8.5%) 시약 HPV test 분자진단시장 1 위 (M/S over 60%) 동반진단시장선두기업 글로벌네트워크보유 - 26 개자회사 - 99 개국가, 88 개대리점 QIAsymphony SP/AS (FDA cleared in 2011) Rotor-Gene Q (FDA cleared in 2012) QIAsymphony full system (FDA cleared in 2014) FDA 승인전자동화시스템 전세계 1,250대설치완료 (2014) 주요제품 - 6 FDA cleared tests: CMV, C.difficile, HSV 1/2 etc. - 13 CE IVD tests 8
BD Overview BD MAX system Total sales (2014): $8.4bn No.1 in automatic blood culture system in US No.6 in global Molecular diagnostics(mdx) market (M/S 7.5%) Leading company in bacterial diagnostics. Employees: 30,000 전세계 423대설치완료 (2014) FDA 승인전자동화시스템 Random access Flexibility 소형장비 : 경쟁사대비 1/3 ~ 1/4 수준 9
Key Proprietary Technologies 10
MuDT More than 10 Targets in a single tube TOCE Software Technology Each of multiple targets should be provided in a single channel. Multiple Target Real-time Detection DPO Oligo Technology The sensitivity of multiple targets should be the same as single target does. Oligo Technology The sensitivity of multiple targets should be the same as single target does. Technological completion Multiple Target Signal Generation Oligo Technology Each amplification efficiency for multiple targets Oligo Technology Each amplification efficiency for multiple targets Oligo Technology Each amplification efficiency for multiple targets Multiple Target Amplification should be equal. should be equal. should be equal. Multiplex PCR Multiplex Real-time PCR Final Multiplex Technology in Real-time PCR 11
순위 분자진단회사명 시장점유율 적용기술 ( 유전자증폭 ) 1 Roche Diagnostics 33% Taqman 2 Grifols (Gen-Probe) 10% TMA 3 Hologic (Gen-Probe) 9.5% TMA, Invader, TaqMan 4 Qiagen 8.5% Hybrid Capture, TaqMan 5 Abbott Laboratories 8% Taqman 6 Becton Dickinson 7.5% SDA, TaqMan 7 Cepheid 7% Molecular Beacon, TaqMan 8 Siemens Healthcare 3.5% bdna 9 biomerieux 2.5% NASBA 상위 9개회사점유율합계 90% Source: Grand View Research(2013) 12
특허 유전자증폭기술 특허보유회사 1983 PCR Roche Homogeneous (Closed System) Multiplex (> 10-plex) SNP (> 10 point mutations) Quantification (> 10 analytes) 1989 bdna Siemens 1989 Line Probe Fujirebio 1990 TaqMan Roche 1991 NASBA biomerieux 1992 SDA BD 1993 Hybrid Capture Qiagen 1995 TMA Hologic 1995 Invader Hologic 1996 Molecular Beacon PHRI 1997 Hyb Probe Roche 1999 Scorpions Qiagen 1999 Bead Technology Luminex 2011 TOCE Seegene 2014 MuDT Seegene 13
Conventional PCR DPO PCR DNA Primer 구조 5 3 Primer 는유전자증폭을개시하는인자. 기존 primer 와구조적, 기능적으로차별화 1 5 3 Extension 1 2 3 1 5 3 Extension 1 2 3 2 5 X Extension 3 2 5 X No extension 3 X 이론 3 5 X Extension 3 3 5 3 X No extension X Dual priming 과정통해목표유전자만을특이적으로증폭시킴 결과 불필요유전자다수검출 멀티플렉스적용불가 목표유전자만정확하게검출 높은정확도의멀티플렉스분자진단실현 14
virus 1 virus 2 virus 3 virus 4 virus 5 virus 6 virus 7 virus 8 virus 9 virus 10 virus 11 virus 12 virus 13 virus 14 virus 15 virus 16 virus 17 virus 18 virus 19 virus 20 온도분석 (Melting curve analysis) 을통해단일채널당 5개의목표유전자검출 자유로운 Catcher-Tm value 조절가능 병원균의염기서열변화에관계없이일정한 Catcher-Tm value 단일검사 real-time PCR과동등한민감도 15
Note1: System workflow example of Seegene s Anyplex Ⅱ STI 7 Detection 2. Seegene signed 1) OEM supply contract with Hamilton(US) for NIMBUS; and 2) reseller agreement with Bio-Rad(US) for CFX96 16
Single-channel multiplexing without melting curve analysis 기존 Real-time PCR MuDT Real-time PCR [PCR cycle] 40 ~ 45 회반복 [PCR cycle] 40 ~ 45 회반복 95 60 72 매 cycle 마다 72 에서 유전자증폭시그널확인 95 60 72 매 cycle 마다 60, 72 두온도에서 유전자증폭시그널확인 Target 1 시그널 Target 1 + Target 2 Target 2 시그널 소프트웨어분석 Target 1 시그널별도도출 17 /22
18
Product Pipeline 19
신제품 1. Respiratory Full Panel (4 개패널, 총 26 종검사 ) 신제품 2. STI/BV Full Panel (4 개패널, 총 28 종검사 ) 신제품 3. Gastrointestinal Full Panel (4 개패널, 총 25 종검사 ) 한번의검사로적절한치료가이드제시 Full information of disease Personalized treatment 검사실운영비절감 Instrument Reagent Time Labor 환자검사비용부담절감 Saving from burden of health care cost Saving national medical cost 20
기존진단법 씨젠 Allplex Respiratory Panel 1 Test 1) Screening Test 2) Screening Test 3) Screening & Typing Screening Screening Screening Screening & Typing Flu A Flu B RSV A RSV B Flu A Flu B RSV Flu A Flu B RSV Typing Flu A-H1 H1pdm09 Flu A-H3 If Flu A Positive Flu A Flu B RSV A RSV B Flu A-H1 H1pdm09 Flu A-H3 Reagent Cost > 21
Seegene Luminex (US) BioFire (US) Platform Real-time PCR Liquid-chip Nested PCR Work flow 2 steps 7 steps 1 step Multiplexing 25 14 22 Throughput: # of sample per instrument 24 ~ 96 96 1 Time to first result < 6 hours 8 hours 1 hour Time to 96 results < 6 hours 8 hours 100 hours Hands-on time < 10 min 2.5 ~ 3 hours 3 ~ 5 min Price Low High High 가장많은원인체분석 사용자편의성높음 가격경쟁력 High-throughput 검사가능 검사결과하루만에보고 Gastrointestinal Infection ( 설사질환 ) 복잡한검사방법 매뉴얼작업이많아정확도낮고오염리스크높음 검사비용높음 사용자편의성높으나장비당 1 개검사만가능 50 개샘플검사시 50 대장비혹은 1 대로 50 시간소요 전세계사망원인 5위 (6위는 HIV/AIDS, 7위결핵 ) 전세계감염성질환사망원인 2위 전세계 5세이하어린이사망원인 2위 Diarrhea outbreaks in community and hospital acquired (nosocomial) infectious diarrhea threaten large population 22
제품군 12 개신제품유럽인증 (CE-IVD) 캐나다인증 (Health Canada) 호주인증 (TGA) Allplex RP1 호흡기감염증 (Respiratory Infection) Allplex RP2 Allplex RP3 Allplex RP4 Allplex GI1 소화기감염증 (Gastrointestinal Infection: GI) Allplex GI2 Allplex GI3 Allplex GI4 Allplex STI/BV 1 성감염증 (Sexually Transmitted Infection: STI) Allplex STI/BV 2 Allplex STI/BV 3 Allplex STI/BV 4 승인완료 2015 년승인예정 2016 년승인예정 23
Appendix 1. Industry Overview 24
진단검사분류 Medicine ( 의약품 ) Level 1 Prophylactics ( 예방의약품 ) Diagnostics ( 진단검사 ) Therapeutics ( 치료의약품 ) Surgery ( 수술 ) Others ( 기타 ) Level 2 in vivo Diagnostics ( 체내진단검사 ) in vitro Diagnostics(IVD) ( 체외진단검사 ) Level 3 Hematology & Cytology ( 혈액 / 세포검사 ) General Chemistry ( 일반화학검사 ) Microbiology ( 미생물진단검사 ) Immunochemistry ( 면역조직진단검사 ) Genomics, Proteomics & Metabolmics ( 유전자진단검사 ) Blood banking Viral load test Infectious disease Genetic disorders Source: Datamonitor 25
Evolving IVD Method 증상진단 (Symptomatic Diagnosis) 배양법 (Culture) 면역진단 (Immunoassay) 분자진단 (Molecular Diagnostics) 발병후의사의경험 기반진단법 검체배양통한미생물확인및검사법 질병에의해생성되는항체등간접인자검사법 질병원인 DNA/RNA 분자레벨에서직접검사 현존하는 IVD 검사법중가장빠르고정확한조기진단법 26
80 70 60 50 40 30 20 10 0 15.0 13.0 11.0 9.0 7.0 5.0 3.0 1.0-1.0 글로벌체외진단및분자진단시장규모 글로벌체외진단분야별시장규모 Worldwide IVD Sales : US$45.7bn (2012) 체외진단 ( 분자진단제외 ) IVD market by segment MDx market share (2012) 분자진단 (MDx) 5-yr CAGR: 6.4% 55.6 40.7 2012 2017E 5-yr CAGR: 12.6% 9.1 5.0 Hemostasis 3% Immunoassays, Microbiology 24% 5% Tissue 7% Hematology 7% Immunochemistry 36% Self-monitoring blood glucose 19% MDx 11% Point-of-care 12% (US$mm) 2012 Market share Roche 1,261 25.2% Diagnostics Hologic 721 14.4% Qiagen 581 11.6% Becton 460 9.2% Dickinson Abbott 420 8.4% Cepheid 275 5.5% Siemens 260 5.2% Healthcare biomerieux 90 1.8% Other 936 18.7% Total 5,004 100% 2012 2017E Source: Frost & Sullivan Source: Frost & Sullivan, Company data, broker reports 27
500 450 400 350 300 250 200 150 100 50 0 3.5 3 2.5 2 1.5 1 0.5 0 250 200 150 100 50 0 3.5 3 2.5 2 1.5 1 0.5 0 암검사시장 (US$mm) 동반진단시장 (US$mm) 5-yr CAGR: 13.0% 1,306 5-yr CAGR: 11.9% 224 709 128 2012 2017E 2011 2012 2016E 2017E 2012-2017E 연평균성장률 13.0% 이상 암검사는조기진단수요가매우높은시장. 분자진단이유일하게조기진단이가능한검사방법이기때문에, 암관련유전자의연구가활발히진행되고있으며, 이를기반으로빠른속도로시장이확대될전망 Source: Grand View Research 환자의유전자에따른치료제처방 ( 환자맞춤형치료가능 ) 분자진단검사와제약의동반분야로 2012-2017E 연평균 11.9% 성장전망 Source: Grand View Research 식품안전성검사시장 (US$bn) 동식물검사시장 (US$bn) 5-yr CAGR: 14.5% 2.0 5-yr CAGR: 16.0% 4.2 1.0 2.0 2012 2017E 2013 2018E 식품산업제조및유통과정에서식중독원인병원체를검사하는시장 동 / 식물전염병진단및슈퍼박테리아검사시장 미국및유럽을중심으로식품안전성검사에대한규제가강화되는가운데, 소비자들의헬스케어인식수준향상으로빠르게성장중 Source: Kalorama Information Source: Kalorama Information, Markets and Markets, press release 28
Financial Results ( 단위 : 십억원 ) FY2012 FY2013 FY2014 자산총계 83.6 129.0 138.5 부채총계 41.7 44.6 43.6 총자본금 41.9 84.4 94.8 매출액 51.7 59.0 64.4 매출총이익 35.1 43.8 46.8 판관비 22.9 29.7 35.7 영업이익 12.2 14.1 11.1 순이익 9.1 9.6 9.1 Financial Ratios ( 단위 : %) FY2012 FY2013 FY2014 ROE 21.7 11.3 9.6 Current Ratio 719.3 626.4 780.8 Debt Ratio 99.4 52.8 46.0 Interest Coverage Ratio 8.9 10.5 6.4 GP Margin 67.9 74.2 72.7 EBITDA Margin 28.3 29.4 26.1 OP Margin 23.6 23.9 17.3 NP Margin 17.6 16.2 14.2 Note: 2014 년실적부터연결기준 29
Any statement in this presentation about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward- looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning proposed financial guidance, macroeconomic conditions, future results of operations, growth opportunities, product development, clinical trials, regulatory timelines and approvals, industry ranking, plans and objectives of management, the market for our stock, and future management and organization structure are all forwardlooking statements. Forward-looking statements are not guarantees of performance and involve both known and unknown risks, uncertainties and assumptions that may impact actual results. Levels of activity, performance or achievements may differ materially from those expressed or implied. Seegene assumes no obligation and expressly disclaims any duty to update any forward-looking statements based on events after the date of this presentation or to reflect subsequent events. 30