deloitterecap torreya 110612webinar optimaltimetopartner(1)
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Deloitte Recap Webinar SeriesLicensing Insights: Generating Better Deals, Faster
November 6, 2012Deloitte Recap LLCwww.recap.com
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Agenda
Introduction to the Licensing Insightswebinar series
Strategies knowing what youwant; establishing what you can get
Mapping key deal criteria to thestrategy
Every deal is a special deal case
studies
Eric Walczykowski
Recap Business Leader, Deloitte Recap LLC
John CullityPrincipal, Torreya Partners
Mark SimonPrincipal, Torreya Partners
Lisa NatansonSenior Analyst, Deloitte Recap LLC
David GhesquiereIndependent Business Advisor
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Module 1: Determining the Optimal Time to Partner
Transaction timing drivers Value inflection recently achieved / anticipated over coming months Comparable transactions successfully effected Investor liquidity requirements / demands
Key operational factors for consideration Asset specific strategy
Evaluation of domains of developmental risk Access to capital
Balance SheetCurrent InvestorsCapital Markets
Alternative partnering strategiesNon core geographic territoriesAlternative therapeutic applications / LCM
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Module 1: Determining the Optimal Time to Partner
Data analysis Case histories: Assessing the transaction landscape for deals of similar qualitative
type (e.g. therapeutic area, stage of development, geographic region, dealarchitecture)
Financial comparables: upfronts, milestones, royalties and total deal
Related case studies Small biopharma with single Phase I small molecule asset; breast cancer North Asian regional transaction: Keeping the program alive
Phase II trials results missed primary, achieved several secondary endpointsPOC success or failure, or neither?Regional transaction with local development and commercialization rightsnegotiated, with potential participation in broader regional geographiesResult: Cost mitigation and further program maturation
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Business Development Strategies
Preparing for the sell-side market
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Documentation Term Sheet ContractStructuringStrategicAnalysis Valuation AllianceGovernanceNegotiation
Due diligence: Document
review Evaluation Preparation;
what ifs Financials Plan:
objectives,strategy,tactics
Develop Call List Teasers Develop Slide
Decks Prepare
DiligenceMaterials
Modelconstructionbased on NPVAnalysis
Assetbenchmarking
IP, contracts, Ownership
structure, Liabilities/ assets; Business plan
Bi-, multi-lateral,hub-and-spoke
Steeringcommittee(s)
Designate
managers Dispute resolution:
- Renegotiation- Disengagement- Arbitration,- Litigation,- Termination
Assess currentassets vs.strategic plan
Assess market/patentsituation
Refine clinicalstrategy
Refine CapitalMarketsStrategy
Deal structures Creating term
sheets
An integrated approach to addressing the entirety of the businessdevelopment process, from assessment of strategic options through to
alliance management of completed transactions
Licensing Process Matching Strategy to Context
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Major core elements for consideration in partnering documents Preclinical Clinical Regulatory CMC
IP Commercial
Partnering documents for development
Teaser (non-confidential memorandum) Non-confidential deck Confidential deck Electronic dataroom
This will be the focus ofthe next webinar
addressingCommunications
Module 2: Determining the Optimal Partnering Package
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Effective assets matching between buyerand seller significantly increases theprobability of transaction completionPairing occurs on several domains:therapeutic area, stage of development,cost of downstream clinical trials toname a fewWe have captured these domains forsome 900 active buyers ofbiopharmaceutical assetsDiscussion of our approach and theassociated module will take place duringthe third webinar of this series
The third webinar inthe series will address
Interested Parties
Module 3: Determining the Optimal Partner
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In our view, a good part of the value is created by the clinical, regulatory, CMCand IP surrounding an asset.However, economics are founded upon the capacity to rigorously quantify andcommunicate asset related value.Consequently, we gravitate to comparables based analysis afforded bydatabases such as Recap by Deloitte and product related forecasts.With regard to the latter, we often advise our clients to consider commissioning primary market research to consolidate an understanding ofnet (or reimbursed) price and projected demand.Experience tells us that rigorous valuations work effectively, anchors the
economic dialogue, and often represents a catalyst for transactions.
Commercial assessments will be the topic of thefinal webinar in this series, Valuations
Module 4: Determining Asset Value
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Data Analysis
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Upfront Payments vs. Clinical RiskWhen is the right time to license?
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$2.0$7.3
$17.0
$34.4$43.0
$60.0
$0
$20
$40
$60
$80
$100
$120
Lead Preclinical Phase I Phase II Phase III Registration Approved
Worldwide (All Major Markets) Median
Phase I to Phase II brings the highest increase in upfront
$102.0
Worldwide deals (all three Major Markets) from Lead through Approved stages disclosing the upfront paymentProduct and Technology licenses signed from 1/1/2009 through 7/15/2012 * Major Market Territories include ANY of the U.S., Europe, or Japan; Worldwide territory includes ALL of the US, EU, and Japan
Stage of Asset at Signing
M e
d i a n U p
f r o n t
( $ M
)
102% increase in median upfrontat Phase II
Data Source: Deloitt e Recap LLC
Upfront Payments Increase by Stage
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Failure rates are highest in Phase II development
This "waterfall" graph shows the number (and percent) of clinical projects entering each Phase of development (blue bars) and thenumber terminated at each Phase (red bars) only pursuits that have reached a definitive clinical development outcome of Marketor termination are shown; ongoing efforts are not included. The data are real clinical attrition rates for products sponsored by 316biotechnology companies.
17% ApprovalSuccess Rate
21%
-315
-720
62%1,167
Development Stage of Asset
N u m
b e r o
f P u r s u i t s
1,482
-161
36%447
286
-34
12% 252
Phase I Phase II Phase III Regulatory Filing Market
More than half of allindication pursuitswill fail at Phase II
Data Source: Deloitt e Recap LLC
Clinical Attrition Rates Decrease by Stage
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Oncology (n=590) Autoimmune/Inflammatory (n=106)
Neuroscience (n=143) Infectious Disease (n=173)
21%cumulative
success rate
62%73%
14% ApprovalSuccess Rate
10% ApprovalSuccess Rate
13% ApprovalSuccess Rate60%
20% Approval
Success Rate51%
21% ApprovalSuccess Rate
Attrition and success vary by disease
Phase II Attrition Rates by Therapeutic Area
Data Source: Deloitte Recap LLC
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$2.0$7.3
$17.0
$34.4$43.0
$60.0
$0
$20
$40
$60
$80
$100
$120
Lead Preclinical Phase I Phase II Phase III Registration Approved
M e
d i a n
U p
f r o n
t ( U S $ M ) Worldwide (All Major Markets) Median
When is the right time to in-license or out-license?
$102.0
102% increase in upfront payment
Phase I hurdle (safety) cleared
62% Phase II risk ahead
Worldwide deals (all three Major Markets) from Lead through Approved stages disclosing the upfront paymentProduct and Technology licenses signed from 1/1/2009 through 7/15/2012
* Major Market Territories include ANY of the U.S., Europe, or Japan; Worldwide territory includes ALL of the US, EU, and Japan
Phase II is optimal for Sellers
Phase III and Registration arefavorable for Buyers
Stage of Asset at Signing
M e
d i a n U p
f r o n t
( $ M
) 25% increase in upfront
payment
Phase II hurdle (Proof ofConcept) cleared
36% Phase III risk ahead
40% increase in upfrontpayment
Phase III hurdle (reproducibleefficacy) cleared
12% Regulatory risk ahead
Upfront Payments Versus Risk
Data Source: Deloitt e Recap LLC
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Looking at the Major Strategic AlternativesOption What it Means Pros Cons
Outright sale orMerger of Company
Sell full control of company forvalue today
Simple and clean transaction of knownvalue
No continued exposure to clinical andcommercial risk
Potential value of lead asset andpipeline likely to be heavily discountedfor clinical and commercial risk
Lead asset likely to dominate valuation
Structured Sale ofCompany
Sell control for a combination ofupfront payment, milestones, and
royalties or final buyout
Likely to be highest headline price andprovided share of upside
Milestones and royalties can be
monetised monetized laterBuyer undertakes commercialisation
Continued exposure to clinical andcommercial risk
Exposure to risk of buyer change instrategy (no chance to take backproducts)
Administrative complexity and long tailon payments (but they can bemonetized)
Outright sale of leadasset and relatedcompounds
Sell full control of lead asset forvalue today, distribute all or part ofproceeds
Retain pipeline for further
development and future value
Simple and clean transaction of knownvalue with no continued exposure toclinical and commercial risk of leadasset
Opportunity to create incremental
value in retained pipeline using part ofproceeds
Potential value of product likely to beheavily discounted for clinical andcommercial risk
Need to continue management of
company and pipeline
Structured sale oflead asset and relatedcompounds throughlicensing or relateddeal
Sell commercialization rights forcombination of upfront and futurepayments, such as:
Upfront Payment Clinical/Regulatory milestones Launch/Sales milestones Royalties
Maintain some control of developmentand possibly greater future upside
Opportunity to create incrementalvalue in retained pipeline using part ofproceeds
Mechanism to recover lead asset inevent of discontinuation
Complex to negotiate & administer
Continued exposure to clinical andexecution risks
Long tail on proceeds (though thesemay be monetizable later)
Need to manage company and pipeline
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Access to Capital
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Capital Raising: Reflecting on the Sources
Investor participation
Venture CapitalGeneral and Limited Partner constraints
Venture debt High net worth / family offices Public markets
IPO sentimentFollow on rounds
Royalty monetization On the riseGovernment and foundations
Sources of non-dilutive capital via grantsLicensing and asset sale Becoming more structured, and arguably harder to complete; option based, back-
ended Addressing the competing needs for risk mitigation and portfolio augmentation
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1H2012 vs. 2009-2011
Life Science VC Deal Volume by Subsector
0
20
40
60
80
100
120
TxDev/Del
Dx/PMTP
20092010
2011
1H 2012
Data Source: ZephyrBiotech LLC
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0.00
500.00
1000.00
1500.00
2000.00
2500.00
TxDev/Del
Dx/PMTP
2009
2010
2011
1H 2012
Life Science VC Investment by Subsector (MUSD)1H2012 vs. 2009-2011
Data Source: ZephyrBiotech LLC
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October IPOs 20% above their IPO prices
KYTHERA Biopharmaceuticals lntercept Pharmaceuticals
$-
$100
$200
$300
$400
$500
$600
$700
$800
$900
Average $61M $57M $60M
2010 2011 2012n=13 n=11 n=17
IPOs
Data Source: Deloitt e Recap LLC
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Regional Transactions by Design vs. Default
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Regional by Default Considering the Transaction Profile
Situation
Company misses pre-specified primary but with positive trends Major Pharma players fall away as a result Risk-averse behavior come back to us when you have unambiguously positive data Challenging to re-calibrate value before Big Pharma following release of sub-optimal data
Typical dealarchitecture
Modest upfront < $5M Shared development costs of Regional RCT Regional rights ceded Percentage of global rights ceded
Outcomes
Regional Co. gains negotiated percentage of global net sales (royalty obligation) Regional trial unlikely to satisfy global regulatory requirements Global players may not grant much credence to regional player and associated clinical trial Financial players may identify partial validation
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Regional by Default Case Studies
Case Study #1
Situation: European company. Phase IIOphthalmology asset.
Challenge: Phase II clinical dataequivocal. Missed primary outcome. Hitsome secondary outcomes.
Solution: AsiaCo generics focusedophthalmology company seekingbackward integration. Manufacturingcapacity available. Regional growthambitions.
Action: Regional transaction design.Regional developmental and commercialrights. 50% cost of regional Phase II.Modest upfront. Clinical, regulatory andcommercial milestones. Manufacturingsupply agreement for region. Percentageof global rights to AsiaCo.
Case Study #2
Situation: US company. Phase IIRespiratory asset.
Challenge: Phase II clinical data negative.Missed primary and secondaryoutcomes.
Solution: EuroCo generics / brandedfocused respiratory. Regional andinternational growth objectives.
Action: Regional transaction design. EUdevelopmental and commercial rights.
Cost of EMA accepted Phase II RCTcovered. Modest upfront. M Clinical,regulatory and commercial milestones.Transfer price agreement on clinicalbatch and commercial supply. Percentageof global rights to EuroCo.
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Case Study
Small biopharma with single Phase I asset
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Case Study Background
Platform target based company (proprietary receptor-based bioassays; severallead candidates including monoclonal and small molecules) Strategy to leverage single Phase I (breast cancer) small molecule for
follow-on molecules and therapeutic areas (prostate cancer andosteoporosis)
Deliverables: Identify relevant partners Identify comparable deal precedents and deal models Analyze by development stage key deal terms, financials, and structures
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Category Selection Criteria
Technologies All technologies
Deal Structure License; Broad collaboration; Co-development
Partners Pharmaceutical company; biotechnology company
Clinical Phase Survival Rates Oncology
Therapeutic Areas Cancer
Stage at Deal Signing Lead molecule; Preclinical; Phase I; Phase II
Territory Worldwide
Selection Criteria for Benchmarking
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Benchmarking Deal Characteristics
Analyze current asset to 161 recent cancer deals with respect to: Deal characteristics that differentiate the range of upfronts ($100k-
$150M) Stage at signing Clinical survival rates
Data Source: Deloitt e Recap LLC
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Deals Comparables
Selected 10 deals for Phase I vs. Phase II licensing Phase I: $ 26M Phase II: $ 332MIdentified deal opportunities with ranked competing criteria
Marketed: 3 Filed: 1 Phase III: 9 Phase II: 36 Phase I: 20
TherapeuticArea
TotalDeals
(n)
No. DealsDisclosingUpfrontPayment
AggregateDisclosed
TotalUpfront
Payments($M)
Range MeanUpfrontPayment
($M)
MedianUpfrontPayment
($M)
(n) (%)
Cancer 161 35 22% $681.7M $100k-$150 $19.5M $8.5M
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Category Selection CriteriaTechnologies Small molecules; monoclonal
Deal Structure Co-development
Clinical Phase Survival Rates Breast cancer
Partners Biotechnology company
Competing drugsPhase I and II sorted by target type in diseaseindication
Therapeutic Areas Narrow focus on target type and disease indication
Endpoint with contingencies Phase II
Territory Worldwide with regional exclusions
Narrow Selection Criteria for Comparables
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Comparables with narrow focus on target type and disease indication: breastcancer and receptor types = 30% survival (vs. 11 for non-receptor)
Narrow Comparables Clinical Phase Survival Rates
Data Source: Deloitt e Recap LLC
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Current financial environment demands a proactive partnering strategysupported by strong deal analyticsKey initial step is determining financing options (IPOs, licensing, M&A,options)Benchmark potential deals against several modelsNo two deals are identical Consider a regional by design transaction strategy
Summary
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Deloitte | Torreya Licensing Insight
Deloitte | Torreya Licensing Insight combines the analytical power of Deloitte
Recap with the demonstrated experience of Torreya Partners in the setting ofbiopharmaceutical transactions advisory and financing
Top tier investmentbanking and pharma /biotech executives
Intimate understanding ofpharma / biotechtransaction processes
Extensive track record andbiopharma relationships
Reputation as thoughtful,objective and experiencedprofessionals which fostersreceptive audience withinpharma
Deloitte Recaps premierinternationalbiopharmaceuticaltransactions database
Experienced team ofbiopharma consultants andadvisors
The power of Deloitte withwrap around services inmarket research andfinancial structuring
Deloit te | TorreyaLicensing Insight
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Contact Deloitte Recap for More Information
Stay tuned for details on the next webinarModule 2: Determining the Optimal Partnering Package
Subscriptions and Consulting
+1 855 381 4748 | [email protected] | www.recap.com
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36h |
About DeloitteAs used in this document, Deloitte means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description of the legal structure ofDeloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.
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