Diagnostic and Medical Device Capabilities Boston Strategic Partners, Inc.

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1 Diagnostic and Medical Device Capabilities

2 Boston Strategic Partners is uniquely qualified to work with diagnostic and medical device companies on a variety of engagements Broad experiences with the diagnostic and medical device industries (Brief Overview) BSP professionals have worked on a variety of engagements with diagnostic and medical device companies on multiple platforms from high-throughput clinical chemistry and immunoassay instrumentation companies to automated imaging based molecular diagnostic companies to those developing novel radiolabeled pharmaceuticals / imaging reagents Engagements include scientific publications, gap analysis, long-term strategy planning, theranostic / personalized medicine / PGx opportunity assessment, and advisory board facilitation Recently enabled both a general diagnostics player as well as a molecular diagnostics player to explore options for different disease states beyond current expertise with the goal of decreasing the cycle time from initial symptoms to diagnosis using in-vitro diagnostic tests Led an engagement to identify target markets in Europe for a manufacturer of automation of reading of FISH (fluorescent in-situ hybridization) images in Oncology diagnosis as well as pre- and post natal medicine Strategy to address diagnostics needs in emerging markets such as BRIC countries addressing both differences in patient flow and ensuing platform needs as well as different disease types Recommendations for what functionality needed to be incorporated on mobile/ portable diagnostic and imaging devices of Pan European advisory board to address emerging strains of influenza and other respiratory viruses as well as new platforms that could provide screening and surveillance more efficiently Invited speaker to international conventions to discuss the future of laboratory/post laboratory medicine at the IFCC in Glasgow (May 2005) and the AACC in Orlando (July 2005) Consultant to the CDC on a broad range of diagnostic initiatives in order to improve patient outcomes BSP professionals have advanced degrees from top tier schools in medicine, virology, immunology, chemistry and business along with substantial hands on research experience 2

3 BSP professionals have expertise in a diverse set of strategic engagements Guiding a medical device company through the restructuring of their organization after acquisitions and assessing the future state of the business Defining the economic value of novel central laboratory diagnostic tests Financial modeling as a tool to analyze the impact of multiple acquisitions through the consolidation of revenue and operating costs Primary research was conducted across multiple countries and across multiple stakeholders for companion diagnostic in lung cancer expansion, utilization, and clinical value were attributes that needed clarification as our client was consolidating their market position in gastro diagnostics Primary research to inform our client s deployment strategy for a novel blood-based assay for colorectal cancer screening and New Guiding development of new pharmacogenomic tests and gene targets with an analysis of epidemiology and key constituents Clinical review article summarizing the pathogenesis and current clinical diagnostic tools and therapies available for the development of osteodystrophy as a result of kidney disease Facilitated a cross function team of management with in a medical device company to reduce redundancies and inefficiencies Developing the mature phase of a proprietary nucleic acid testing (NAT) platform by evaluating expansion into non-clinical adjacent markets Financial Analysis Segmentation Acquisition Strategy Clinical / 3

4 Appendix: Project examples

5 Guiding a medical device company through the restructuring of their organization after acquisitions and assessing the future state of the business Conducted market research to determine the competitive positioning of the future state business post acquisitions Assessed how various business functions could be consolidated and integrated to improve efficiency Developed a financial model to determined the financial impact of the acquisitions A high level executive summary and supporting appendices to CEO and Senior Management Allowed our clients a vision of the future state of their company, a restructuring strategy, and a platform from which to pursue future growth opportunities Over a 7-week time frame BSP worked closely with the client to: Conduct market research to provide the client with an overview of their competitive positioning before and after mergers Provide a strategy that discussed future drivers for success to ensure growth in new markets and gaps that needed to be filled to strengthen their current position and provide a potential for future growth Assist the client with the integration of a shared services approach, which consolidates major business functions, minimizes overlap, and streamlines operations Work with the client to restructure and reorganize the current and future businesses to support the shared services approach Develop a pro forma financial model to capture incremental costs and savings resulting from acquisitions to give the client a financial picture of the future state of their business The executive summary provided a roadmap that outlined the restructuring of the new company Supporting documents detailed how the different business elements could be managed post merger BSP helped the client better understand how their acquisitions affected their market presence The roadmap provided the client with a consolidation strategy moving forward to maximize savings and minimize costs The consolidation strategy provided our client with a transition plan and facilitated the integration of future acquisitions 5

6 Financial modeling as a tool to analyze the impact of multiple acquisitions through the consolidation of revenue and operating costs Conducted interviews with management to asses the impact of restructuring on operating costs Developed a pro forma model to capture incremental costs and savings resulting from acquisitions Consolidated income statements to predict EBITDA contributions and operating expenditures for the future organization A series of plug and play financial models across various functions and acquisitions to Senior Management Allowed our clients to understand financial outcomes resulting from their acquisitions and provided a tool to assist with future acquisition strategies BSP assisted the client through a functional assessment of the operational expenditures of their current company landscape and its acquisitions to determine incremental costs and savings opportunities through synergies and consolidation BSP assisted our client in determining the impact that merging the businesses would have on the current and future states of facilities and headcount for each business. From this data, our client was able to develop a reorganization strategy to maximize savings and minimize costs All gathered data was incorporated into a pro forma model to reflect the incremental change the acquisitions would have on the P&L statements for each business The corresponding income statements were then consolidated to provide our clients with an overall financial picture of the future state of their business post merger BSP presented multiple financial models in a modular format to allow the flexibility to asses how different combinations of functions and/or acquisitions would impact future income BSP helped develop a financial picture of the postacquisition company The model enabled our client to evaluate their restructuring plans and discover further savings and consolidation opportunities By offering the financial model in a flexible format, BSP allowed the client the ability to easily assess the impact of future acquisitions 6

7 expansion, utilization, and clinical value were attributes that needed clarification as our client was consolidating their market position in gastro diagnostics Conducted secondary research and created questionnaire specific for GI market Integrated previous project on strategic planning with market research Utilized web-based survey for rapid acquisition of responses Document was used as part of a due diligence process for upper management Allowed client to gain understanding of existing and potential customers needs The client acquired an advanced GI product in manometry and wanted to understand the utilization, product recognition of their brand, and potential for expansion into other markets Goals of the research were: to assess opportunities in adjacent markets to understand clinician value to understand value of technological advancements compared with competitors to evaluate how often new technology is purchased Developed 45 minute web based survey for 40 doctors and nurses including, urology, ENT, gastroenterology to understand market position, clinical acceptance, clinical unmet needs, and limitation of technology BSP created an integrated document that had previous work pertaining to the client s strategic goals The integrated document was used to further the client s understanding of the GI space The market research helped create a more complete picture of the GI space and identified key features that stakeholders use to make their purchasing decisions Final recommendations suggested a number of call points as well how the client s product and company was perceived in terms of competitive positioning, brand reputation, and technology 7

8 Guiding development of new pharmacogenomic tests and gene targets with an analysis of epidemiology and key constituents Epidemiologic analysis to estimate clinical needs within diseases as well as across broader therapeutic areas Identify diseases and therapeutic areas to be impacted most by improved clinical outcomes and tests Create models to characterize financial impact of product commercialization Deliver business scenarios backed by data analysis to CEO and Senior Management Identification of best-fit partnerships and R&D opportunities to guide resource dedication efforts Our client recognized that because their products possess potential to extend the window of disease management beyond typical diagnostic-therapeutic-monitoring paradigms, typical test/drug business development scenarios could not sufficiently guide their commercialization efforts BSP professionals analyzed unmet needs, epidemiology, efficacy/side effect profiles and market growth rates both within and across classes to identify broad therapeutic areas and specific diseases where the client s unique products would yield the most meaningful clinical impact BSP conducted interviews with key constituents and experts to quantify the value of improved outcomes to pharmaceutical companies, payors, and providers; Type 2 diabetes, thrombosis, and hepatitis C emerged as the most feasible while asthma did not meet our client s minimum criteria The BSP team presented three revenue and two funding models to support R&D and further evaluation or pursuit of potential partnerships BSP helped our client to quantify the value of potential partnerships as well as identify different ways to create maximum value within a partnership We also helped our client to avoid less feasible therapeutic areas BSP enabled our client to allocate their resources appropriately and conduct further due diligence 8

9 Facilitated a cross function team of management with in a medical device company to reduce redundancies and inefficiencies Cross divisional team facilitation Strategy assessment of current business operations Method used: Standard workshop Document to upper management Organized, facilitated, and summarized results of meeting Facilitated meeting between large functional division groups in large medical device company to reduce inefficiencies and enhance effectiveness Functional groups were: Molecular Diagnostics Clinical Diagnostics Point of Care Diabetes The goals of the meeting to be appear as one voice to clients and be as productive as possible Coordinated several different divisions in a forum where many perspectives were present Notes were taken on a day-to-day basis, with summary and future pursuits as they were laid out in the meeting Organized a list of hurdles and areas for collaborations that could be addressed for client and divisions Document with clear goals, summary, and future directions BSP presented information to meeting participants and upper management which described the main objectives and results of the meeting BSP helped to uncover both hurdles and areas for collaboration where some of the inefficiencies existed and could be addressed 9

10 Defining the economic value of novel central laboratory diagnostic tests Collaborate with client to determine the disease states with the highest unmet needs to be modeled Secondary research for each disease of models for each state including the economic impact of proposed opportunity Executive summary presented to upper management Allowed the client to understand the new test needs, specifications, and economic impact of a prioritized list of opportunities The client hired Boston Strategic Partners (BSP) to provide support in defining the economic value of novel diagnostic testing opportunities The goal of the project was to identify pharmacogenomic opportunities across a wide selection of high profile disease states, based on potential health economic value to the system Understand ideal market opportunities Opportunities for entire therapeutic areas and specific commercialization opportunities within therapeutic areas Prioritize between these test opportunities, based on market potential and necessary specifications for a commercial test BSP developed a separate model for each therapeutic area to assess the impact to payers (costs avoided), patients (mortality/morbidity), and pharma Modeling identified both broad principles for evaluating potential opportunities, and flagged specific high value markets Through the modeling process, several theorized tests were identified and assessed for each disease area / test Executive Summary containing models for 13 different disease states and a prioritized list of disease state opportunities for test development based on value for patients, payors and pharma, and on the necessary test specifications For each of the 13 disease areas, BSP identified the unmet diagnostic needs and the benefits of developing such a test (eg. Hepatitis C) BSP s models clearly articulated the financial and humanistic value to payers, patients, and pharma for each disease areas 10

11 Primary research was conducted across multiple countries and across multiple stakeholders for companion diagnostic in lung cancer Created primary and secondary research featuring stakeholder interviews Face to Face and telephone interviews were required by client Analyzed data using qualitative and quantitative methods Document used by senior management as part of global marketing plan Document gave clear patient flow information to client The client wanted to understand patient flow and doctor involvement every step from diagnosis to treatment for a companion diagnostic product Some of the key questions that the client wanted to know were: How were different specialties involved in the process? What were the ideal characteristics of the test? What was the information needed by clinicians to feel comfortable ordering test for patient? Developed discussion guide for all stakeholders including screening criteria and mock scientific primer Face to Face and telephone interviews were conducted with 194 physician specialties from the US,UK, France, and Germany to gain understanding of their role in the treatment and diagnosis of the indication. Compared and contrasted results from the EU and US of the various stakeholders involvement in the patient flow to arrive at clear analysis and set of recommendations Document clearly explaining market overview, primary research results and recommendations moving forward BSP team presented results to senior management to further discussion concerning strategic plan Patient flow information uncovered critical differences among countries which allowed the client to emphasize different aspects of the product to different stakeholders Final recommendations included launch planning, product positioning, pricing and reimbursement, testing specifics and data needed by clinicians 11

12 Primary research to inform our client s deployment strategy for a novel blood-based assay for colorectal cancer screening Identified relevant interview population who could provide valuable feedback and drafted detailed questionnaires specific to each demographic Conducted in-depth phone interviews and hosted detailed web surveys to solicit feedback Compiled interview data to provide insight to guide deployment strategy Presentation of the executive summary to the client team Detailed responses from interview process Provided a better understanding of market perceptions and likely acceptance of a new bloodbased CRC screening assay A global health care molecular diagnostic company is planning to launch a novel A detailed summary of BSP provided our client with blood-based assay for colorectal cancer (CRC) screening in the US the interview findings, which included key Given the performance characteristics (e.g. sensitivity, specificity, delivery method) factors that impact of the new blood-based assay, the client would like to understand: market uptake and The likelihood of market acceptance and inclusion in clinical practice clinical practice guidelines guidelines decisions Common CRC screening methods employed in the clinical setting in order to categorize the market position of a blood-based assay among other CRC screening options Clinicians satisfaction with current CRC screening methods The role of clinical practice guidelines in actual CRC screening practice Most beneficial methods for disseminating information regarding a bloodbased assay valuable information to support its deployment strategy: A clear understanding of how guideline writers and clinicians will evaluate and utilize a blood-based CRC assay positioning of bloodbased assay in CRC screening Challenges and hurdles for market adoption and guideline inclusion Prioritized channels for informing and educating clinicians and guideline writers 12

13 Clinical review article summarizing the pathogenesis and current clinical diagnostic tools and therapies available for the development of osteodystrophy as a result of kidney disease Identify potential authors Compose comprehensive outline Revise content and suggest changes Submission of article for review Craft strategy composed of clinical research and summary articles targeted towards payers and medical specialists Bone disease occurs as a secondary complication of kidney disease in most patient A pharmaceutical company has an approved therapy that can slow the progression of disease if used early in the disease process The company wishes to publish a basic review article to highlight renal osteodystrophy in an effort to increase awareness of the benefits of early diagnosis and treatment BSP team members collaborated with the client to research the literature and compose a comprehensive outline and manuscript BSP professionals worked with the client to identify and contact authors for the completed manuscript Upon review of the manuscript BSP team members made suggested changes, and resubmitted the revised manuscript for publication Article was submitted to the Clinical Journal of the American Society of Nephrology Article published in 2008 Identify and contact qualified authors through widespread network Experience with logistics of publications 13

14 Developing the mature phase of a proprietary nucleic acid testing (NAT) platform by evaluating expansion into non-clinical adjacent markets Conducted secondary and primary research to identify potential adjacent market opportunities Conducted market research to characterize the market size of each identified opportunity Identified key market dynamics in order to provide prioritization of assessed adjacent markets were presented to senior management Provided an assessment of adjacent market opportunities for our client s proprietary NAT platform Through secondary research, BSP was able to identify six adjacent market opportunities for which our client could leverage its proprietary NAT platform to enter the market Opportunities were stratified according to two categories: Nascent markets -- client will need to drive adoption of NAT Established markets -- client will need to differentiate its product offerings from those of its competitors BSP identified the overall market potential of each opportunity by assessing key market segments, market size, and growth rates Conducted primary research with potential non-clinical customers to understand key attributes that will impact NAT uptake in non-clinical markets Opportunities were prioritized based on overall market potential, barriers to entry, time to market, development costs required, NAT usage potential, and potential partnership opportunities BSP professionals provided upper management with an executive summary that outlined the nonclinical adjacent market opportunities and prioritization for market entry In addition, appendix document were provided that detailed market size, market segmentation, and growth rates for the adjacent market opportunities Our client was presented with prioritized adjacent non-clinical market opportunities for their proprietary NAT platform, which had at the time only been employed in clinical settings BSP created an understanding of the opportunities for the clients and a direction to develop the mature phase of their NAT platform; which could allow them grow future revenue 14

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