QIAGEN Sample and Assay Technologies

Transcription

1 QIAGEN Sample and Assay Technologies Dresdner Kleinwort 4th German Midcap Conference New York, September 27, 2007 Ulrich Schriek Vice President Corporate Business Development -1-

2 Forward Looking Statements Safe Harbor Statement: Certain of the statements contained in this presentation may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products and markets and operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations), variability of operating results, the commercial development of the DNA sequencing, genomics and synthetic nucleic acid-related markets, as well as the nucleic acid-based molecular diagnostics, applied testing markets and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations for certain events including funding, budgets, and others), difficulties in successfully adapting QIAGEN s products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors, and the integration of acquisitions of technologies and businesses. For further information, refer to the discussion in reports that QIAGEN has filed with or furnished to the U.S. Securities and Exchange Commission (SEC). Note: In this presentation, QIAGEN is using the term molecular diagnostics. The use of this term is in reference to certain countries, such as the United States, limited to products subject to regulatory requirements. Current QIAGEN molecular diagnostics products are one FDA approved product, four products with 510k clearance from the FDA, 38 EU CE IVD assays, six EU CE IVD sample preparation products, nine China SFDA IVD assays and 98 general purpose reagents. Regulation G: The following slides contain certain summary information about QIAGEN N.V. s sales, gross profit, operating income, net income, and earnings per share, which information is presented on a non-gaap financial measures basis rather than in accordance with U.S. generally accepted accounting principles ( GAAP ). Please review QIAGEN s recent press release, for information on the company s operating income, net income, and earnings per share for these periods presented on a GAAP basis. Such GAAP-basis information will also be contained in the company s reports on Form 20-F or Form 6-K to be filed with or furnished to the U.S. Securities and Exchange Commission. -2-

3 QIAGEN at a Glance Intro Revenues: 2006: $ 466 million CAGR: 15% Net income: 2006: $ 85 million CAGR 22% 1 EPS: 2006: $ CAGR: 21% 1 Product Range: >500 consumable products Sample technologies: to collect, separate, purify, isolate, stabilize and store samples Assay technologies: to make such isolated target information (DNA, RNA, proteins, etc.) visible Instrumentation for above consumables Customers (>400,000) Academic research Pharma/Biotech Applied Testing (veterinary, forensics, biodefense etc.) Molecular Diagnostics IP (08/07): >1 500 patents (550+ issued, 480+ pending, 500+ licensed Employees: ~2 600 employees based > 30 subsidiaries 1 excluding acquisition, integration and relocation related charges as well as amortization of acquired IP and equity-based compensation (SFAS 123R) -3-

4 Intro Complex sample Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, trna, Salts, Polymerases, Centrioles, Immunoglobulins, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, DNA, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, trna, Salts, Polymerases, Centrioles, DNA, Immunoglobulins, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, trna, Salts, Polymerases, Centrioles, Immunoglobulins, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Talin,... Sample Technologies Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, trna, Salts, Polymerases, Centrioles, Immunoglobulins, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, DNA, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, trna, Salts, Polymerases, Centrioles, DNA, Immunoglobulins, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Megacaryocytes, Plasma, Clotting factors, Actin, Microfilaments, Serum, Fibrin, Lysosomes, Ezrin, DNA, Hemaglobins, Heptaglobins, Transferrin, Fibrinogen, Serum albumin, trna, Salts, Polymerases, Centrioles, Immunoglobulins, Carrier proteins, Cytokines, Angiotensins, Chemokines, Bradykines, Plasma membranes, Ribosomes, Actin, Vesicles, Complement components, Nuclei, Rough endoplasmatic reticulum, Nucleoli, Golgi apparatus, Glycoproteins, Microtubules, Mitochondria, Mitochondrial nucleic acids, Vacuoles, Talin, Nucleolus, Polymerases, Ceramides, Chromosomes, Chromatin, mrna, Cytoplasm, Leucocytes, Sugars, Lipids, Salts, Urea, Carbonic acids, Cofactors, Precursors, Hemoglobins, Erythrocytes, Monocytes, Smooth endoplasmatic reticulum, Macrophages, Thrombocytes, Platelets, Lymphocytes, Basophils, Eosinophils, Neutrophils, Talin,... Pure Analyte DNA Assay Technologies Target Dectected Yes No Information -4-

5 Sample and Assay Technologies Intro Technology Leadership Sales Strength MDx Appl. Testing Pharma Biomedical Research Inside Sales E-commerce M A R K E T S Growth Drivers Financials

6 Sample and Assay Technologies Technology Leadership Technology Leadership Sales Strength MDx Appl. Testing Pharma Biomedical Research Inside Sales E-commerce M A R K E T S Growth Drivers Financials

7 QIAGEN Sample Technologies Enabling Access to the Content of Any Biological Sample Technology Leadership Any Biological Sample Any Application Any Analyte -7-

8 QIAGEN Assay Technologies Assay Technologies Technologies: All forms of DNA, RNA, methylation, proteins Amplification of target or of signal (including: PCR, real-time PCR, multiplexed PCR, Rolling Circle Amplification, HybridCapture) Whole Genome/Transcriptome amplification RNAi assays Formats Automation Open kits (generic) Closed kits (target-specific), e.g. molecular diagnostics Hardware design Software development Electronic engineering Technology Leadership -8-

9 QIAGEN Consumables Manual use or Automated on QIAGEN Instruments Technology Leadership Consumables Instruments Sample Technologies - Forensics - Clinical 50 cm 5 cm - Everywhere - Pharma Assay Technologies - Molecular Diagnostics 20 cm -9-

10 QIAGEN Technology and Innovation Leader Technology Leadership R&D at QIAGEN: Approx. 10% of sales >440 employees in R&D Germany, U.S., Switzerland and China Chemistry, biology, physics, engineering and others Fast, proven innovation cycles: 4-5%-points of sales growth comes from new products launched in last 12 months -10-

11 QIAGEN has Significant Marketing and Sales Power Sales Strength Technology Leadership Sales Strength MDx Appl. Testing Pharma Biomedical Academia Inside Sales E-commerce M A R K E T S Growth Drivers Financials

12 Strong Sales and Marketing Force Sales Strength Europe Approx 41% of Sales Sales and Marketing Force: 450 America Approx 46% of Sales: Sales and Marketing Force: 432 Asia Approx 11% of Sales Sales and Marketing Force: 229 S P E C I A L I S T S Channels MDx Appl. Testing Pharma Biomedical Research Inside Sales E-commerce M A R K E T S > 1,100 Sales and Marketing Professionals -12-

13 Revenue Distribution Sales Strength By Product Groups By Geographic Regions By Customer Groups Consumables sample technologies assay technologies Asia RoW 3% of sales Molecular Diagnostics Applied Testing 90% 9% 27% 48% 11% 8% 36% 52% 24% 27% 10% 17% Instruments Europe America Pharmaceutical Industry Research All figures based on annualized estimates -13-

14 QIAGEN is Addressing Key Growth Markets Growth Drivers Technology Leadership Sales Strength MDx Appl. Testing Pharma Biomedical Research Inside Sales E-commerce M A R K E T S Growth Drivers Financials

15 Growing By Leveraging Technologies Growth Drivers All figures are estimates Market Size (US$ M) Market Growth QIAGEN Revs (% of Sales) Growth Drivers MDx 2, % 48% Applied Testing Pharma 1, % 17% Research % 8% 1, % 27% Replacing trad. Dx New applications Becoming routine Molecular biology going everywhere Personalized medicine Clin. trials monitoring Translational research Replacing traditional Biomedical research Translational research -15-

16 Disseminating Technologies Into Four Markets Growth Drivers Molecular Diagnostics Applied Testing Pharma Life Science Research SAMPLE Technologies ASSAY Technologies Product and Technology Continuum -16-

17 Leading in Molecular Diagnostics Growth Drivers Sales in MDx (run rate Q2 2007): approx. $380 million #1 (excluding blood banking and viral load monitoring) Sample technologies: proven standard Molecular Diagnostics Assay technologies: unparalleled breadth (>120 assays) PCR and real-time PCR assays Multiplexing leader: QIAplex Leading in key assay areas (HPV) Broad platform base Regulated portfolio global and growing 5 FDA (PMA approved or 510k cleared) products 38 CE-marked assays, 6 CE-marked sample preparation products 9 SFDA approved assays 98 general purpose reagents -17-

18 Global In Vitro Diagnostics Market By Segment (2006E) Growth Drivers In Vitro Diagnostics Estimated Market Volume: ~US$ 33B (2006) CAGR : 7% Molecular Diagnostics Estimated market volume: ~US$ 2.4 billion (2006) CAGR : 17% Hematology CAGR 3.9% Other CAGR 3.5% Immuno-assays CAGR 4.7% Clinical Chemistry CAGR 2.6% Molecular Diagnostics US$ 2.4B CAGR 17.0% Blood banks Others Viral Infections Microbiology CAGR 5.7% Blood Glucose CAGR 11.5% Oncology Genetic Testing Non-Viral Infections Hemostasis Coagulation CAGR 10.2% Point of Care CAGR 10.9% MDx: Fastest Growing Segment in In-Vitro Diagnostics Note: IVD market estimates vary by source and range between ~$29B $35B Source: RBC Capital Markets, Nature Biotechnology (August 2006), Digene internal reports, Recap, Kalorama, BioCentury, L.E.K. Analysis -18-

19 QIAGEN Platforms Sample Processing Sample Technology Automation (Broad portfolio of QIAGEN solutions) Biorobot MDX BioRobot 8000 BioRobot M48 BioRobot EZ1 QIAcube Detection Rapid Capture Real-time PCR cycler (standard lab equipment ABI, Roche, Corbett) Endpoint PCR cycler (standard lab equipment, off patent 2008) Liquichip (Luminex) Genetic Analyzer (egene) Assay technology Hybrid Capture Quantitative PCR QIAplex multiplexing Qual. PCR QIAplex low Throughput Ultra-high All (open platform) Medium Medium Assays HPV, CT/GC and others 120 real time PCR assays ResPlex, MVPplex (HAI) HLA and others -19-

20 Significant Untapped Potential for HPV Testing Growth Drivers Increased global awareness of the link between HPV and cervical cancer U.S. Current tests: ~ 8.4M Penetration rate: ~ 22% Europe Current tests: ~ 2.0M Penetration rate: ~ 6% Accelerated adoption into medical guidelines Vaccine campaigns promote awareness New genotyping tests expand market to include HPV positive patients Significant untapped potential within developing countries Infrastructure + breadth of combined offering key Asia/Latin America: Current tests: 0.9M Penetration rate: ~ 3% Europe ~ $350M Asia/Latin America ~ $280M U.S. ~ $490M Total: >$1.1 billion Substantial Growth Potential - Increasing Awareness -20-

21 European HPV Primary Screening Acceptance Phase/Status of National HPV Screening Acceptance Public Health Phase 1 Thought Leader or Champion Phase 2 Published Research Norway, Denmark, Sweden, U.K. Spain, Portugal Belgium, Switzerland, Eastern Europe Phase 3 Population- Based Screening Trial Phase 4 Clinical Utility Proof Accepted Phase 5 Cost Benefit/HTA Phase 6 Consensus France, Germany, Italy Phase 7 Guidelines, Algorithms, Recommendations Netherlands, Finland Phase 8 Demonstration Project & Pilots Phase 9 Public Policy, Funding Best practice HPV screening model for EU Regional primary screening prior to national acceptance September 2007: German Technology Assessment Team study recommends adoption of HPV testing (study on request of federal government) National Rollout Patient Education, Awareness -21-

22 Multi-Channel Approach in Molecular Diagnostics Awareness Direct to Consumer Advertising Campaigns Focus: HPV Awareness OB/GYNs take sample and send to lab Clinical Sales Force (80 Professionals) Focus: HPV Awareness Laboratory performs test Laboratory Sales Force (170 Professionals) Focus: Complete Portfolio Focus: Transactional Sales OB/GYNs communicate result -22-

23 Expanding in Applied Testing Growth Drivers Sales (Q2 run rate) approx. $60 million Sample technologies: proven standard Assay technologies Veterinary Surveillance (e.g. avian flu) Applied Testing Focusing on forensics, veterinary, biosecurity Others: food, quality control environmental, lifestyle Great success in forensics (sample technology is key!) Exciting product launches in 2008 in veterinary Proven Industry Standards Fuel Molecular Testing in Applied Markets -23-

24 Pharma Growth Drivers Sales (Q2 run rate) approx. $130 million Sample technologies Pharma Research & Development Assay technologies Open and closed assays Multiplexing RNAi, Whole Genome Amplification, Biomarker Programs, Biobanking technologies Pharma trials go molecular QIAGEN s unique position: bridging research-pharma-mdx We can accompany partners through all phases Multiple partnerships for Dx content Enabling Technologies for Next Generation Drug Development -24-

25 Standard in Academic Life Science Research Growth Drivers Sales (Q2 run rate): approximately $210 million Sample technologies: leading standard Life Science Research Assay technologies : leading standard PCR, real time PCR (primarily open assay technologies) RNAi Others Creating standards early in new, emerging fields E.g. mirna E.g. Epigenetics Large component of Life Science is biomedical research At the Forefront of Science Creating Standards Early -25-

26 Integration Plan Integration Planned to Take 12 Months Growth Drivers Resources Closing July 30 rd TODAY Organization Fully Implemented Announcement June 3 rd Target Completion July 2008 Months Pre- Planning -26- Pre- Closing Implementing 12 Line function takes over all responsibilities Analyst and R&D Days Planned in 2008

27 Integration Snapshot Post Merger Integration Projects Growth Drivers Bus. Dev. HR Finance R&D Operations Marketing Projects by functional area Major projects already completed Organizational structures announced Projects defined (over 90) Internal communication platforms Sales Major project groupings Functional ERP-related Next milestones Tracking of cost and revenue synergies SAP for the combined companies NA&EU going direct Organization Europe Going Direct North America Going Direct Integration is going fast Major projects already completed within six weeks -27-

28 QIAGEN Strong Financial Base Exciting Model Financials Technology Leadership Sales Strength MDx Appl. Testing Pharma KAM Biomedical Research Inside Sales E-commerce M A R K E T S Growth Drivers Financials

29 QIAGEN Revenues E Financials US$ millions CAGR = 15% E Revenues excluding the synthetic DNA business unit, sold in Q QIAGEN Continuous Double Digit Revenue Growth Rates -29-

30 QIAGEN Net Income E Financials US$ millions CAGR = 22% EPS Adj E US$ 0.32 US$ 0.39 US$ 0.46 US$ 0.56 All figures excluding acquisition, integration and relocation related charges as well as amortization of acquired IP and equity-based compensation (SFAS 123R) QIAGEN Strong Earnings Engine US$ US$

31 Second Quarter 2007 At a Glance Financials Q Q Growth QIAGEN % Digene % QIAGEN Pro Forma % ~$770 million annualized sales growing at 22% -31-

32 Key Investment Considerations Summary Leading, focused: sample and assay technologies Strong financial performance Strong growth projected: organic growth rate: ~15% Proven innovation leadership in industry Successful acquisition track record Core competency drives growth opportunities MDx Pharma<->MDx Applied Testing Leading catalytic acquisitions to expand: Sample and assay technology leadership Regional footprint -32-