CELLO HEALTH BIOCONSULTING - Capabilities Presentation
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Cello Health BioConsulting Overview Leading business development strategy consulting firm, assisting clients in the pharmaceutical, biotech and healthcare investment industries for more than 25 years Four core lines of business, each focused on helping clients build and strengthen their companies: Opportunity Assessments Opportunity Search & Evaluation Portfolio and Platform Strategy Corporate and Partnering Strategy Capabilities deck © Cello Health BioConsulting 2021 2
Cello Health BioConsulting is a Part of Cello Health A worldwide team of more than 400 based in the US and UK A UNIQUE FUSION OF EXPERTISE TO SOLVE PROBLEMS, REDUCE RISK AND UNLOCK THE FULL POTENTIAL OF ORGANIZATIONS, ASSETS AND BRANDS INSIGHT & ANALYTICS STRATEGY & COMMERCIAL SCIENCE & EVIDENCE 200 Market Researchers, Master Practitioners, Digital Specialists, Innovation leads, Field and Compliance 140 Communication Specialists, Scientists & Creatives including Client Service, Project Offices in London, Farnham, New York, New Jersey, San Francisco, Managers and Medical Writers Chicago, Philadelphia and Boston Philadelphia 70+ Consultants with a blend of industry experts and consulting specialists London Chicago New York & New Jersey 60+ PhDs and MDs providing a depth of understanding into cutting edge science San Francisco Farnham Boston Capabilities deck © Cello Health BioConsulting 2021 3
Cello Health BioConsulting Areas of Expertise and Capabilities Core Services Opportunity Assessments Opportunity Search & Evaluation Portfolio and Platform Strategy Corporate and Partnering Strategy Capabilities deck © Cello Health BioConsulting 2021 4
Cello Health BioConsulting Core Services Opportunity Opportunity Search Portfolio and Corporate & Assessments & Evaluation Platform Strategy Partnering Strategy Assess commercial value in Establish criteria for Analyze and prioritize Facilitate C-suite strategic markets of interest identifying programs that pipeline portfolio “workshopping” to develop Evaluate mechanistic fit with strategy Identify and assess novel corporate and partnering approach and scientific Identify assets and/or indications for strategy for value rationale companies that best match development optimization Position and differentiation criteria Prioritize and sequence Deal benchmarking and from evolving SoC Work with our client to potential indications valuation Define target patient prioritize opportunities Define value inflection Pitch deck refinement and populations, clinical Provide deeper analysis of strategy for clinical messaging endpoints and target priority targets candidates ID and facilitate discussions product profiles Identify value inflection Advise on optimal time and with target partners Determine payer points to optimize stage of development for Advise on deal structure perspective partnering strategy partnering and value to support negotiation Capabilities deck © Cello Health BioConsulting 2021 5
Cello Health BioConsulting Deep Knowledge Across Therapeutic Areas • Cello Health BioConsulting has a deep knowledge base within and across all therapeutic categories. Cardiovascular Autoimmune & Oncology CNS • The focus of our work closely mirrors the & Metabolic Disease Inflammatory therapeutic area focus of today’s biopharmaceutical pipeline. • Cello Health BioConsulting’s research is conducted by its trained consultants, all of Respiratory Ophthalmology Orphan Diseases Gastro-Intestinal whom have PhD or MS degrees and/or significant relevant experience in pharma and the targeted scientific areas. • Our consultants possess a combination of commercial, scientific, and clinical Platform Gene & Cell Therapy Dermatology Infectious knowledge that enable comprehensive Disease Technologies analyses and actionable recommendations. And other emerging areas of interest such as NASH & fibrosis Capabilities deck © Cello Health BioConsulting 2021 6
Cello Health BioConsulting Insight Across the Clinical Development Value Chain, with Particular Focus on Early-Stage Assets Cello Health BioConsulting’s combination of scientific sophistication and strategic/commercial insight provides a competitive advantage for its core offerings across the clinical development value chain, with particular emphasis on assets in early phases of development. Scientific Focus: Translation of mechanism to potential Clinical and Commercial Experience: Guidance on clinical value proposition strategies for differentiation Preclinical Clinical Launch Opportunity Assessments, Indication Prioritization, and Strategy Identify Value Inflection Points, Forecasting and Valuation Payer Research, Pricing Analysis and Optimization Opportunity Search and Evaluation Corporate & Partnering Strategy Capabilities deck © Cello Health BioConsulting 2021 7
Insight from Key Stakeholders • Cello Health BioConsulting has developed an extensive network of relationships with key stakeholders. Patients • Our consultants conduct in-depth collegial Partners discussions with physicians and payers to understand their perspective on the value of development-stage assets as well as product portfolios and platforms. Payers • We also have the ability to do patient research to gain key insights into patient needs and willingness to pay for new Physicians products. Capabilities deck © Cello Health BioConsulting 2021 8
CHBC Brings Unique Perspective to Defining Value Proposition Cello Health BioConsulting believes that the key to driving value inflection for early stage compounds is to go beyond mechanistic proof-of-concept to demonstrate clear potential for clinical differentiation and commercial value. To capture this sentiment, CHBC has coined the phrase “proof-of-relevance.” Proof • To survive, biotech companies must embark on clinical programs that go beyond scientific proof-of- concept (demonstrating that the science is PoR applicable to the disease) to prove that its approach provides a clinically and commercially relevant value proposition that makes the program attractive of to all stakeholders Relevance In its opportunity assessments, Cello Health BioConsulting provides unique perspective on clinical and commercial attributes that can (and must) be addressed in early stage clinical trials in order to demonstrate PoR. Capabilities deck © Cello Health BioConsulting 2021 9
Opportunity Assessments 10
Opportunity Assessments Commercial assessments of development-stage assets are the nucleus of Cello Health BioConsulting’s continuously growing experience, insight and knowledge, across therapeutic areas. Commercial Assessment Framework • The methodology includes a combination of primary and secondary research REFINED TARGET PRODUCT PROFILE whereby a target product profile is created, refined, and evaluated within the Secondary Research context of the product’s unique market Treatment, Epidemiology, and competitive environments. Pipeline, Market Overviews, Benchmarks • The output typically includes insight into Preliminary TPP the product’s market potential (in the form Client’s internal view of of high-level analysis or full revenue/NPV compound Primary Research models) as well as recommendations for KOL, Front-line physicians, payers value optimization at various points in development. Capabilities deck © Cello Health BioConsulting 2021 11
Opportunity Assessments Cello Health BioConsulting employs the following information resources when conducting opportunity assessments for clients: Secondary Telephone Web Research Interviews Surveys Provides the data to support the One-to-one in-depth telephone Web-based surveys with US and EU analysis and primary research discussions with the following across physicians the US & EU Sources include, but are not limited to: Provides insight from a larger sample • Key Opinion Leaders (KOLs) (typical projects range from 50-200 • company pipelines • Front-line physicians respondents) • prescription & pipeline databases • Payers (Medical Directors, Pharmacy • analyst reports & SEC filings Directors, Hospital Pharmacists) Survey questionnaire is drafted and • medical info sites viewed with the client before launch • scientific literature and conference Prior to these in-depth discussions, proceedings CHBC drafts a discussion guide(s) and a Results from the surveys are analyzed • industry publications target product profile which are refined and presented graphically along with • information gathered from publicly with the client to meet the project key takeaways from the physician available resources objectives research Capabilities deck © Cello Health BioConsulting 2021 12
Primary and Secondary Research Through the combination of primary and secondary research, Cello Health BioConsulting’s opportunity assessments evaluate four key areas: 1 Unmet Need 2 Scientific • Epidemiology, patient segments, • Scientific basis/validation for disease and treatment the mechanism landscape – current and future • Degree of differentiation and • Level of clinical or patient need ability to address unmet needs • Key remaining unmet needs • Potential limitations associated with the product’s profile 3 Commercial 4 Development • Value proposition within current • Clinical development path and and future treatment algorithms critical endpoints for success • Pipeline quantity, quality, and • Expected regulatory novelty challenges or roadblocks • Market access and pricing • Anticipated clinical environment and challenges development risk Capabilities deck © Cello Health BioConsulting 2021 13
Additional Components of Opportunity Assessments Opportunity assessments also frequently include the payer and financial components below. We view these as additional core competencies of our business. Cost-effectiveness Payer Forecasting Models Research and Valuation Determine current cost Assess market access, Create dynamic and of care and quality of life reimbursement and pricing adaptive patient-based and metrics environment prescription-based forecasts Develop a value-based pricing Determine potential coverage Benchmark valuations using model that takes into and formulary status/ comparable deal analysis consideration a willingness to restrictions Produce risk-adjusted NPV pay threshold, improvements Evaluate what additional models of companies, to QoL and costs savings clinical/ pharmacoeconomic products, and deals provided data is needed Perform sensitivity analysis Identify relevant pricing Pressure-test price and of inputs to determine key analogs establish pricing benchmarks value drivers Capabilities deck © Cello Health BioConsulting 2021 14
Cost-Effectiveness Models • For price testing/optimization, Cello Health BioConsulting uses a comprehensive approach to arrive at a Payer price that is derived from value-based Research pricing models, health economic/payer guidance, and relevant pricing analogs. • CHBC develops dynamic value-based pricing models based on the NICE model. Our consultants then pressure-test the VBP during one-on-one discussions with key stakeholders in the market access Pricing space and triangulate it with pricing Analogs benchmarks of relevant analogs. Value-Based Price • We believe this multi-pronged approach ensures that the price attained is reasonable and justifiable. Capabilities deck © Cello Health BioConsulting 2021 15
Payer Research Cello Health BioConsulting’s payer research evaluates key questions in the following six areas: ♦ Plan type by segment ♦ Coverage determinations ♦ Current cost of care in the ♦ Costs and unmet needs by based on pharmacy or target patient segments segment medical benefit ♦ Target price point ♦ Reimbursement by segment ♦ Expected copays ♦ Floor and ceiling price points Value Trial Design & Restrictions on Inflection Data Required Use Points Coverage & Patient Formulary Pricing Segmentation Status ♦ Desired improvements in ♦ Endpoints to show value ♦ Restrictions of currently outcomes ♦ Patient criteria to show the available drugs ♦ Key drug characteristics greatest value ♦ Anticipated future restrictions payers willing to pay for ♦ Level of improvement to justify ♦ Pricing thresholds for ♦ Current unmet needs price stricter/looser restrictions Capabilities deck © Cello Health BioConsulting 2021 16
Forecasting and Valuation Patient Population & Treatment • Financial forecast modeling is an essential • Epidemiology component of Cello Health BioConsulting’s • Key patient segments based on treatment practices valuation capabilities. • Addressable patient segments • We build revenue forecasts (patient- or prescription-based) in a user-friendly Excel Competition • Current and future competitive landscape format to allow our clients to see in real- • Impact of new entrants/generics/ biosimilars time how changes and sensitivities around • Impact of competition on peak revenue potential distinct variables impact the forecast. • In addition, we provide benchmarking Penetration valuation of individual assets, platforms and • Anticipated use based on product’s value proposition company portfolios as well as risk-adjusted • Potential adoption & uptake NPVs in Excel with sensitivity analysis • Appropriate analogs surrounding the key inputs. Pricing • Appropriate/acceptable price based on current & future market • Impact of market access landscape on pricing potential • Potential level of rebating/discounts Capabilities deck © Cello Health BioConsulting 2021 17
Opportunity Search & Evaluation 18
Search & Evaluation of Opportunities • Cello Health BioConsulting assists clients by helping to define and execute on strategic goals to either establish a new presence or grow an existing presence in specific therapeutic and specialty areas. • Cello Health BioConsulting has more than 25 years of experience that result in an incomparable ability to evaluate and prioritize markets and potential opportunities. Capabilities deck © Cello Health BioConsulting 2021 19
Search & Evaluation of Opportunities • Cello Health BioConsulting has established Develop screening criteria and generate a comprehensive & transparent process initial list of potential opportunity candidates (assets or companies) 1 CRITERIA for identification and qualification of actionable partnering and in-licensing opportunities. Screen for assets and SCREEN 2 companies against inclusion • We evaluate potential opportunities with criteria our broad understanding of the current state of scientific, development and Compile data, commercial environments within specific review and evaluate opportunities 3 EVALUATE diseases. • Cello Health BioConsulting provides Rating & valuable insights and assists in prioritizing of the most compelling assets available to RATE & PRIORITIZE 4 tiering with rationale meet the client’s objectives. 5 OVERVIEWS/BUSINESS CASES FOR PRIORITIZED OPPORTUNITIES Capabilities deck © Cello Health BioConsulting 2021 20
Search & Evaluation of Opportunities We take a comprehensive, multi-pronged approach to evaluating potential licensing/acquisition candidates. • Scientific Evaluation: understand the base mechanistic approach, and potential application to disease areas, as well as the current level of validation Scientific • Commercial Evaluation: provide an assessment of the market need and growth potential for the intended indication; compound’s ability to address unmet need, impact on the treatment paradigm, and competitive environment challenges Commercial Clinical & • Clinical/Regulatory Evaluation: identify Opportunity Regulatory the clinical development risk for the product; likelihood of success in late-stage clinical trials and/or with FDA approval Capabilities deck © Cello Health BioConsulting 2021 21
Portfolio and Platform Strategy 22
Portfolio and Platform Strategy Portfolio Identification & Prioritization • Cello Health BioConsulting works with many emerging biotech companies to 10 Indication D prioritize their pipeline portfolios and Opportunity Attractiveness define the best pathways to value inflection 8 Indication A • Typically, these programs are 6 Indication F at pre-clinical to early clinical development Indication C (Phase I-Phase 2a) so opportunity remains 4 Indication E to shape the development program to Indication G maximize potential for clinical and 2 commercial success. Indication B 0 • Output often includes a definition of 0 2 4 6 8 10 therapeutic strategy and best transaction Potential to Overcome Risk & Challenges model going forward. Path to value inflection is completely clear and facile Path to value inflection is moderately clear and facile Path to value inflection is uncertain and/or difficult Capabilities deck © Cello Health BioConsulting 2021 23
Indication Prioritization Process • Cello Health BioConsulting has Compile starting list of indications to established a comprehensive & multi- identify all those that meet specific client triage criteria 1 INDICATION TRIAGE step process for the evaluation & prioritization of potential indications. INDICATION Triage & evaluate indications • Our process can facilitate EVALUATION AND SCORING 2 based on assessment identification of the most attractive framework indications for our client’s assets, technologies, and platforms. Prioritization of • We believe that a collaborative attractive indications to meet client’s goals 3 RANK INDICATIONS FOR DISCUSSION WITH CLIENT process will provide the best outcome for this assessment and will engage WORKSHOP TO DISCUSS Workshop the client team with regular status updates throughout the project and & FINALIZE PRIORITIZED LIST OF INDICATIONS 4 & final ranking will solicit input/feedback where appropriate. 5 IN-DEPTH ASSESSMENTS OF PRIORITIZED INDICATIONS Capabilities deck © Cello Health BioConsulting 2021 24
Indication Prioritization – In-Depth Assessments In addition to the evaluation and prioritization process, Cello Health can provide in-depth indication assessments (deep dives) that would provide a more robust and nuanced understanding of each indication as well as the potential for success of the client’s program in each selected indication. Findings from primary and secondary research will be synthesized to provide out clients with a strategy for indication selection and sequencing for their programs. Capabilities deck © Cello Health BioConsulting 2021 25
Corporate and Partnering Strategy 26
Let’s Work Together to Optimize Your Company’s Value Aligning partnering strategy with • An interrogated, thoughtful and defensible corporate corporate development strategy strategy is essential for optimal valuation and capitalization and should drive partnering strategy. • Decisions about whether and what and when to partner Robust scientific, competitive and and at what value and with which partner—whether your commercial due diligence company is buying or selling (or in- or out-licensing)— are critically important for inflecting or depleting value. • It is therefore essential to outline and exquisitely execute a Technology search & evaluation, valuation partnering strategy that aligns with and facilitates & forecasting and deal benchmarking achievement of corporate development, financing and pipeline goals and that reflects an appreciation of the value proposition, competitive landscape and positioning, market access / pricing and reimbursement environment, and deal Advise on deal terms & structure to benchmarks and favorable deal structure and value. prepare for and support deal negotiation Capabilities deck © Cello Health BioConsulting 2021 27
Cello Health BioConsulting Brings Deep Scientific, Biopharma Business & Dealmaking Experience WE ARE DEEPLY ROOTED IN SCIENCE. We are expert at assessing mechanisms-of-action, assets, pipelines and platforms, and comparing and positioning assets within the relevant competitive landscape. We can anticipate and help you overcome challenges from potential partners as a seller, or help you assess opportunities as a buyer. WE ARE DEEPLY ROOTED IN BIOPHARMA BUSINESS. We understand your challenges and pressures and what inflects or destroys value as you advance your company and programs. We understand the competitive landscape and relevant deal benchmarks to appropriately value and position assets or programs to secure the deal you want. WE ARE DEEPLY ROOTED IN ASSESSING AND VALUING BIOPHARMA ASSETS AND PROGRAMS. Understanding the science, the biopharma business, the competitive and deal landscapes, and what drives value in your space, enable us to evaluate data with the eyes (and skepticism) of a potential buyer. We can conduct “mock due diligence” to prepare sellers for partnering and we can conduct due diligence for buyers to pressure-test value proposition and deal terms. WE ARE DEEPLY ROOTED IN DEAL-MAKING. We understand you have choices about what and when to partner. We understand how the right deal structure and terms for the right asset at the right time can inflect value and how the wrong deal can impede future progress. We have been where you are and have the deal sheet and case studies to prove it. Whether you are a buyer or seller, a licensor or licensee, let us help you find and secure the best deal for your company. Capabilities deck © Cello Health BioConsulting 2021 28
CHBC Advises Buyers and Sellers to Right-Value Assets & Secure Value-Inflecting Deals Corporate strategy should drive, and be Understanding Buyer and Seller Needs & Corporate Development Goals enabled by, partnering strategy. That’s why Cello Health BioConsulting begins its partnering strategy and support projects with structured, facilitated discussions with your company’s internal stakeholders—as a first step we develop a robust and nuanced understanding of your company’s corporate goals, value proposition, risks and risk-tolerance, and Deal Structure/Value Determination Asset Assessment & Valuation wants and needs in a deal. Preparing for and Advising through Term Sheet Development Your company’s corporate development Deal Negotiation* goals are our roadmap for seeking, Search & Evaluation structuring and securing a right-valued and Deal Benchmarking right-structured deal that positions your Potential Partner Identification, company to facilitate its ambitions and Messaging and Pitch Deck Screening & Prioritization inflect significant value. Development Competitive Landscape Assessment Due Diligence Support & Positioning *CHBC advises & supports clients through negotiation but does not itself transact deals Capabilities deck © Cello Health BioConsulting 2021 29
Buy- and Sell-Side Partnering Strategy and Support Deal Benchmarking Deal benchmarking helps right-set key stakeholder and negotiator expectations for deal value and deal structure and informs negotiation parameters and positioning Cello Health BioConsulting has developed a robust methodological process for deal benchmarking: • identify and assess deals relevant to the deal contemplated by your company— i.e., at a similar stage of development, market opportunity, risk, value, etc. • summarize relevant deals and outline their known material qualitative & quantitative deal terms • elucidate how the predicate deals may translate into your company’s desired deal structure and value • provide a must have/like to have/avoid score for key deal terms (stage, scope, exclusivity, territory, diligence, etc.) and outline deal value ranges (upfronts, R&D payments, development, regulatory and commercial milestones, royalties, sublicense fees, etc.) to inform term sheet and deal structure development and negotiation parameters and priorities • list and summarize relevant deals and key takeaways to prepare your company for deal valuation and negotiation Capabilities deck © Cello Health BioConsulting 2021 30
Buy- and Sell-Side Partnering Strategy and Support Advising on Deal Value and Structure It is incumbent on your company to understand what is essential or desired in a deal to enable your company’s corporate development goals and inflect value; to understand the balance of power and value between your company and your potential partner; to understand your leverage and pressure points; to anticipate arguments and develop winning positions in advance of deal negotiations; to pursue and secure a good deal, or walk away from a bad deal, for your company. Cello Health BioConsulting has significant business development and deal negotiation / transaction experience across therapeutic areas and stages of development and, while we do not transact agreements, we can advise your company on potential deal value and the pros and cons of different deal terms, structures and provisions for your company. We walk alongside our clients to develop and refine messaging and positioning for internal and external stakeholders to help your key executives / business development team advocate for the deal you want and, ultimately, for the value of the deal you’ve secured. We can help your team avoid deal loss from your own board room. Capabilities deck © Cello Health BioConsulting 2021 31
Cello Health BioConsulting Leadership Team Ed Saltzman Ginger S. Johnson, PhD Executive Chairman Chief Executive Officer esaltzman@cellohealth.com gjohnson@cellohealth.com Senior Management Jeffrey M. Bockman, PhD Beth Fordham-Meier, BS, CLP Michael C. Rice, MS, MBA EVP, Oncology Practice Head Vice President, Business Development Vice President jbockman@cellohealth.com BFordham-Meier@cellohealth.com mrice@cellohealth.com Janet F. Czachura David J. Lomb, PhD Danielle M. Marra, MS, MBA Principal Principal Principal jczachura@cellohealth.com dlomb@cellohealth.com dmarra@cellohealth.com Principals Joel S. Sandler, PhD James T. Lee, PhD Principal Principal jsandler@cellohealth.com jlee@cellohealth.com Senior Serom Lee, PhD Steven Smith, PhD Andrew Y. Ng, PhD Senior Consultant Senior Consultant Senior Consultant Consultants slee@cellohealth.com ssmith@cellohealth.com andrewyng@cellohealth.com Capabilities deck © Cello Health BioConsulting 2021 32
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