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1、Bridging Pharmas$200 million commercial gapRobust contingency plans to capture full asset potentialStrategy&|Bridging Pharmas$200 million commercial gap3ContactsGermanyChristian WilkensPartner,Strategy&Germany+49-151-5656-1668christian.wilkens Dr.Malte KremerPartner,Strategy&Germany+49-160-9620-3714

2、malte.kremer Dr.Christian Wieber Director,Strategy&Germany+49-170-223-8462 SwitzerlandPieter LommelenDirector,Strategy&Switzerland+41-79-903-3041pieter.lommelenpwc.chDr.Sebastian Kwisda Manager,Strategy&Switzerland+41-79-901-2183 sebastian.kwisdapwc.chAbout the authorsChristian Wilkens is a trusted

3、advisor for PharmaCos and Biotechs for a plethora of commercial topics and the interface to R&D.He globally advises clients with a strong focus on differentiated TA and asset strategies,accelerated clinical development,launch excellence,brand strategies and go-to-market strategies.Based in Frankfurt

4、,he is a Partner with Strategy&Germany.Dr.Malte Kremer advises global PharmaCos and Biotechs on R&D and early commercial topics.Specifically,he focuses on pre-and clinical development of portfolios and assets including their acceleration towards commercialization as well as on setting up R&D organiz

5、ations to deliver efficiently.Based in Berlin,he is a Partner with Strategy&Germany.Pieter Lommelen is a trusted advisor to global HQ and regional HQ PharmaCo clients.He has extensive experience leading global projects in asset,portfolio,commercial and launch strategy.Based in Zurich he leads Strate

6、gy&s life sciences team in Switzerland.Dr.Christian Wieber advises international PharmaCos and Biotechs in the intersection of R&D and commercial topics where he focuses mainly on asset,TA and overarching portfolio strategies and related activities and strategies which are required from the developm

7、ent until launch.Based in Frankfurt he is a director with Strategy&Germany.Dr.Sebastian Kwisda globally advises PharmaCos and Biotechs with an emphasis on R&D topics and the R&D interface to commercial.He mainly focuses on TA-and asset strategies as well as scenario planning during clinical developm

8、ent.Based in Zurich,he is a Manager with Strategy&Switzerland.With the ever-increasing complexity of clinical development and market dynamics,more pharma companies are under-achieving against commercialization timelines and commercial expectations,leaving significant value on the table.Our analysis

9、of new molecular entity(NME)launches over the past two decades shows that 75 percent failed to meet launch expectations.They missed the targeted launch dates by an average of 19 months per asset and underperformed at a rate of around$200 million per asset versus market expectations.This suggests sig

10、nificant room for improvement.One major contributor to underperformance is companies restricted ability to react in a timely manner to change,both internal and external.The need to balance multiple launch programs simultaneously each with increased development and commercial complexity is leaving R&

11、D,franchise,and therapeutic area leaders with limited bandwidth for contingency planning.Too often companies have little in the way of alternatives to Plan A for their pipeline assets.Despite having identified different scenarios and associated forecasts,current models of contingency planning are ty

12、pically insufficient to enable companies to switch gear easily when needed.To minimize delays and maximize revenue potential,companies mustneed to allocate time and dedicated budgets to mapping out alternative development routes and implementing well-structured contingency plans,affording them vital

13、 agility.This means:Starting the planning process early(ideally ahead of clinical development or during Phase I)with a strong commercial and market lens Strategically defining and anticipating all relevant external(and internal)challenges with matching evaluation periods and planning potential mitig

14、ation options Linking contingency plans to key governance,financial,and resource-planning processes.Neglecting these crucial steps puts companies at risk of significant time setbacks and missed revenue opportunities.The importance is magnified when dealing with assets with first-in-class(FIC)or best

15、-in-class(BIC)potential,making efficient preparation and streamlined development timelines even more critical.EXECUTIVE SUMMARYStrategy&|Bridging Pharmas$200 million commercial gap4Strategy&|Bridging Pharmas$200 million commercial gap5I.Assessing the growing complexity of clinical development For a

16、long time,the pharmaceutical market and therefore clinical development was almost exclusively driven by large multinational pharma companies(PharmaCos)focusing on large and lucrative therapeutic areas.The ability to demonstrate a benefit in a particular therapeutic or disease area(TA or DA)was relat

17、ively easy,as Standards of Care(SoCs)or standardized treatment plans typically had not been established.In this context,clinical development required less focus on external events,execution being the biggest lever of success.Accordingly,any assessment of assets target product profiles(TPPs)during cl

18、inical development focused primarily on fairly static goals,such as hitting primary or secondary endpoints in trials.A TPP sets out the intended use,target populations,and other desired attributes of a particular drug or therapy,including its safety and efficacy-related characteristics.These identif

19、y minimal requirements for a positive business case(the downside);what is expected or hoped for(the base case);and what would be considered to outperform expectations(the upside).However,the market environment has changed,with the result that optimal planning during clinical development has become s

20、ignificantly more important as a lever for success.Now,large disease areas have established SoCs,challenging pharma R&D teams to demonstrate more than an incremental benefit for each new product seeking authorization.This in turn has demanded more significant innovation.Many companies have moved to

21、rarer,or even orphan diseases,with less competition,where it is easier to differentiate and justify the need for new products.In the meantime,regulatory changes and increasing market access complexity have made successful clinical development and therefore successful commercialization a more challen

22、ging and costly endeavor.Simultaneously,the pressure on healthcare expenditure has created new challenges around price negotiations.In this increasingly dynamic environment,with a plethora of additional internal and external influences on success,planning beyond the base-case scenario is becoming pa

23、ramount to maximize an assets TPP.1.Inreasing pressure on R&D budgets3.Higher price and value scrutiny 4.Increased competition and established treatment paradigms2.Higher number of more complex,parallel programsInternalExternalSource:Strategy&analyisisEXHIBIT 1Up to now,many companies have struggled

24、 to achieve this for a number of reasonsStrategy&|Bridging Pharmas$200 million commercial gap6Strategy&|Bridging Pharmas$200 million commercial gap7Growing pressure on R&D budgetsTo address the increasing need for innovation and to sustain growth in an evolving environment,many PharmaCos have shifte

25、d their focus away from mature brands toward R&D.At the same time,the return on investment(ROI)of pharmaceutical innovation has decreased in recent years.The increasing pressure to improve returns while reducing cost has produced two main outcomes:An increased focus on hitting or outperforming the b

26、ase-case TPP.With limited resources,very few companies consistently plan to mitigate against the downside TPPs,a scenario that is particularly prevalent for assets with less strategic importance.Additionally,focusing on stakeholder interests(with an inherent expectation of positive news)may have cre

27、ated a bias toward the upside.A shift in focus to smaller-population,less familiar TAs/DAs that“promise”a higher chance of becoming or outperforming the established SoC,due to growing difficulty in demonstrating significant innovation in larger disease areas.Moving into unfamiliar territory makes pr

28、eparation beyond the immediate line of sight harder.As a result,building optimal plans beyond the base case is time and resource intensive,conflicting with increased budgetary pressures.More programs with higher complexityOver recent decades there has been an observable surge in new molecular entiti

29、es(NMEs)making it to market,as well as a steady rise in the expansion of existing products into new indications.Yet the average number of companies responsible for these new launches has not changed.To sustain growth many PharmaCos have increased the number of clinical development programs,with the

30、result that pharma leaders are balancing more decisions and resources across more parallel programs than previously.While a typical company had an average of 41 programs in clinical development(Phase I to III)in 2005,this number had risen to 49 in 20221(a 19.2 percent increase)(see Exhibit 2,next pa

31、ge).While the increasing number of programs alone is difficult to handle,the even more acute challenge in clinical development is the rising complexity of those programs.There are two main drivers for this:First,larger TA/DAs are increasingly competitive,requiring more elaborate ways to differentiat

32、e against an often generic SoC to demonstrate value beyond incremental innovation.Examples of approaches here include head-to-head comparison,devices,new routes of administration,biomarkers,novel(composite)endpoints,and proving the impact on general outcome parameters(for example,a reduction in all-

33、cause mortality).Number of drugs approved019952000200520102015202010201115311818162120152433253033153442384036222322165522566524236666211127121710131415192847342533251930405060NMEsBLAsSource:Strategy&analyisisEXHIBIT 2Novel FDA approvals since 1993Second,many PharmaCos are venturing into new areas(d

34、iseases and modalities,for example cell and gene therapies(CGTs)without a previous footprint in,or prior knowledge of,the field.While these new ventures offer potentially significant returns,many unknowns and risks are associated with clinical development.These include trial recruitment,regulatory a

35、cceptance of data from smaller trials,post-market authorization evidence generation,and pricing models.Next to mitigation of these associated risks of clinical development,preparation of markets ahead of launch is a pre-requisite for success especially for CGTs.Strategy&|Bridging Pharmas$200 million

36、 commercial gap9Strategy&|Bridging Pharmas$200 million commercial gap8Regulators To promote sustained innovation while ensuring treatment affordability,regulators across the world are continuously reviewing and adapting their policies,processes,and requirements.In this dynamic market,ensuring sustai

37、ned success as a PharmaCo is no easy feat.In the context of asset development,particular challenges include:Higher evidence requirements,including real-world evidence(RWE)Timeline challenges and delays in clinical assessments with regulatory authorities Limited scientific consultation capacity with

38、regulatory authorities in advance of the approval process.Additional complexity for PharmaCos surrounds the need to anticipate key changes in relevant markets across the globe,and to assess how ongoing programs will need to be adapted to accommodate those changes.Market accessMarket access environme

39、nts are also becoming increasingly challenging,requiring PharmaCos to develop multiple scenarios per asset per target market based on the possible outcomes of:1.HTA and/or benefit assessments2.Pricing negotiations3.Reimbursement4.Access along the product lifecycle.Understanding the relative challeng

40、es of individual target markets,and how the respective scenarios are likely to evolve in each,can have an influence on clinical development,as well as evidence generation plans.Higher value scrutinyWhile internal changes have contributed to increasing complexity,most of the new drivers for modificat

41、ions to clinical development planning are external.Between 2008 and 2021,prescription drug launch prices grew by 20 percent annually;in the year from 2020 to 2021,47 percent of newly launched drugs in the U.S.hit market prices of more than$150,000 per year2.The surge in prices,as well as the growing

42、 availability of effective,high-priced drugs for previously untreated patients,has created novel challenges for healthcare budgets,with an impact on regulatory and market access environments.The changing environments across key stakeholder groups are intensifying the pressure on commercially optimiz

43、ed clinical development,not helped by growing differences between target regions.Recent examples of policy changes include:The European Medicines Agencys(EMA)recent introduction of EUnetHTA.The EU-wide regulation tool aims at supportings collaboration between European health-technology assessment(HT

44、A)organizations that brings added value to healthcare systems at a European and national level.3 The creation of stronger regulations in Germany around the negotiation of reimbursed prices and reduction of spending caps(for example,for orphan drugs),by the GKV-Finanzstabilisierungsgesetz(FinStG)4.Th

45、e introduction of U.S.legislation in 2021 to close the orphan drug loophole,which has seen drugmakers“piggybacking”on the orphan status of an older drug.The Closing Loopholes for Orphan Drugs Act seeks to stop this by limiting the orphan drug exclusion to only apply in instances where the drug is us

46、ed for the rare condition or disease for which it was designated.5 The Inflation Reduction Act(IRA)of 2022,also in the U.S.This allows the Centers for Medicare and Medicaid Services authority to negotiate the prices of certain high-cost drugs for the Medicare program.6Strategy&|Bridging Pharmas$200

47、million commercial gap10Strategy&|Bridging Pharmas$200 million commercial gap11Current and future unmet needs across treatment linesAnticipated primary and secondary efficacy of own assetsCompetitors timelinesCompetitors pivotal trial design and(interim)results(for example,patients included,endpoint

48、s used,precision medicine approaches,return on asset)Options to differentiate beyond the asset(e.g.,digital health solutions,programs“beyond the pill”).Established treatment paradigms and increasing competitionExisting treatment paradigms are becoming increasingly entrenched in modern healthcare pra

49、ctice,and new drugs must break through these deeply ingrained ways of thinking.Developing a successful asset that is unlikely to be first-in-class(FIC)or best-in-class(BIC)needs careful positioning;incrementally improving the SoC is no longer sufficient.Rather,PharmaCos should seek to shape markets

50、from the earliest opportunity,and medically engage and educate the ecosystem,so that stakeholders are primed about the coming benefits.Competition has increased significantly across most therapeutic areas too,making it increasingly difficult for PharmaCos to differentiate their offerings.For this re

51、ason,development teams need to continuously monitor the market for evolving threats and opportunities;for factors that could influence the required level of differentiation;and the anticipated impact of a new treatment on the different stakeholder groups.Factors to monitor include:The growing number

52、 of market variables,and options to differentiate new products,reinforces the need for careful planning,prioritization,and scenario-based preparation.Lack of consistent planning,which remains all too common,can have a detrimental impact on both a PharmaCos top and bottom lines,for example in:a.Delay

53、ed reaction to external eventsb.Sub-optimal mitigation measures,due to a lack of resources and insufficient preparationc.A lack of understanding of“no regret moves”(actions that have no downside,which can produce substantial value)and/or“quick wins”.Strategy&|Bridging Pharmas$200 million commercial

54、gap12Strategy&|Bridging Pharmas$200 million commercial gap13II.Analysis of launch success To scope the challenge facing PharmaCos,we conducted a deeper quantitative analysis of launch activity over the past two to three decades.This has revealed that:3.940 years of accumulated asset launch delay ver

55、sus estimations2.116 bn$Pharma companies left on the table in the last 15 years in terms of overall lost sales until launch estimated launch versus actual launch4.On average each asset accumulates lost sales of 200 mln$5.On average each asset has average delayed time of 19 months19 months940 yearsAp

56、proved1.Three out of four do not meet or outperform forecasts4.3.2.1.200 mln$116 bn$lost salesForecastStrategy&Analysis of 500 asset launches since 2006Strategy&|Bridging Pharmas$200 million commercial gap14Strategy&|Bridging Pharmas$200 million commercial gap15In terms of launch delays,an opposite

57、pattern can be seen,where a potential blockbuster had the smallest launch delay at an average of 16 months,ranging up to 22 months for medium assets,and 19 months for smaller ones.It would seem that priorities are generally being set appropriately,as the assets with the highest impact are facing the

58、 shortest delays.However,more than a years delay still implies significant losses for those type of drugs.Looking across the therapeutic areas,there is quite a significant difference by category.While on average the worst performing assets are located in the areas of Respiratory(1),Systemic Anti-inf

59、ectives(2),and Immunomodulators(3),other big therapeutic areas such as the Central Nervous System(5)or Oncology(8)seem to perform slightly better,especially considering the much larger number of assets involved.Therapeutic areas#Non realized salesMonth delayedDermatology166013Sensory Organs16828Endo

60、crine3412116Gastro-Intestinal2812817Genito-Urinary1213721Various2813824Oncology14314818Blood4419617Musculoskeletal2421221Central Nervous System6826323Cardiovascular2926712Immunomodulators2426833Systemic Anti-infectives9429221Respiratory2133628Grand Total58120119Across the therapeutic areas,six in 10

61、 assets failed to reach their expected peak sales within three years of launch,before falling behind significantly against initial expectations.This trend applied across all assets,irrespective of whether they were launched on time.The worst recorded performance in terms of lost sales saw around$305

62、 million in average lost sales from what were initially envisioned as blockbuster assets;compared with$237 million for medium performing assets($350 million-$1 billion peak sales per year);and only$75 million for smaller assets with yearly sales worth less than$350 million.123Medium performing asset

63、s$350 million$1 billion237 lost sales75 lost sales305 lost salesSmaller assets$75350 million Blockbuster$1 billionStrategy&analysis of 500 asset launches since 2006$305 million in average lost sales is the worst recorded performance16month smallest average launch delay for potential blockbusterStrat

64、egy&|Bridging Pharmas$200 million commercial gap16Strategy&|Bridging Pharmas$200 million commercial gap17III.Opportunities for improvementEach product is unique,so the reasons for delays in commercialization or for launches underperforming will vary from case to case.Some delays are the result of co

65、nscious,strategic decisions,for instance.In other cases,disappointing commercial results may be down to poor planning or execution.That said,our own observations reveal that most PharmaCos lack institutionalized contingency-planning processes during clinical development and commercialization prepara

66、tion,and that this is contributing significantly to their outcomes.Typically,companies are so preoccupied with Plan A that they do not devote sufficient time and resources to anticipating and planning for alternative scenarios.To improve their results,companies need to redress this balance.This mean

67、s:Starting the planning process sufficiently early(ideally ahead of clinical development or during Phase I)Viewing product potential through the commercial and market lens much earlier in the life cycle,specifically during clinical development(i.e.,at the start of the planning process)Strategically

68、defining and anticipating all relevant external(and internal)factors that could influence the new treatments market impact and performance Planning additional evaluation periods during clinical development,based on the most critical factors identified Defining potential mitigation options for those

69、factors Linking contingency plans to key governance,financial,and resource planning processes.To navigate the complexity of future asset development,PharmaCos need to rethink contingency planning during clinical development and include a new and more structured approach to developing differentiated

70、assets within the anticipated timelines,on a consistent basis.IV.Contingency Planning 2.0Contingency Planning 2.0 is the next generation of contingency planning,designed to holistically de-risk development and optimize choices beyond clinical development.It differs from current practices in five mai

71、n ways.Specifically,it:1.Involves rethinking clinical development entirely,with an assessment of potential organizational biases toward upside or base case TPPs(for example,shareholder considerations)before moving to the asset level.2.Starts with initial planning of the asset development before or a

72、t the latest during Phase I,when the initial clinical development plan is outlined.4.Requires organizations to move into continuous monitoring of internal and external influences,enabling a stronger and earlier commercial presence to be leveraged,as well as differentiated competitive intelligence(CI

73、)capabilities.3.Is strongly connected to key resource,governance,and financial planning processes.5.Demands that asset teams set up new roles and responsibilities,so people are included early in the development process to reduce the gap between the scientific and commercial perspective of a new asse

74、ts potential.Strategy&|Bridging Pharmas$200 million commercial gap19Strategy&|Bridging Pharmas$200 million commercial gap18Organizational assessmentWe hypothesize that many PharmaCos currently have significant organizational bias toward upside-and base-case target profiles.In other words,they are no

75、t planning for alternative scenarios,which is leaving them exposed.Most standardized processes are being directed to either fulfilling the base case or considering how to realize the assets upside potential.Increasing the upside of any asset chiefly requires organizations to increase the risk of the

76、 development plan(for example,accelerating development,or head-to-head comparison).Contingency Planning 2.0 can brings that risk down and looks to protect the base-case target profile,i.e.,by mitigating the downside.Understanding potential biases and addressing them is crucial to increase organizati

77、onal buy-in before modifying processes at the asset level itself.Start planning at the development outline stage Contingency planning should start before or,at the very latest,during the early parts of Phase I when the development plan is outlined.Contingency Planning 2.0 should ideally involve the

78、following steps:Strategic assessment of the relevance of the therapeutic/disease area(TA/DA)and asset as part of the overall portfolio and company strategy.Ecosystem assessment,including the definition of external influences i.e.,company TA/DA footprint,established SoC,unmet need per relevant ecosys

79、tem stakeholder,competitive pipeline,and anticipated trial read-out dates.Thats in addition to anticipated initiatives“beyond the drug”,the mechanism of action(MoA),plus scientific validation(reason to believe),key markets,and anticipated regulatory and market access events/concerns.Assigning the as

80、set to archetypes based on market assessment:a.Speed either one key competitor(for example,the same new MoA race to be FIC),underdeveloped disease area(orphan)or“winner takes all”market(e.g.,prevalence-driven gene therapy market)b.Differentiation typically in well-developed TAs/DAs with clearly esta

81、blished SoC and strong competition(relevant if achieving BIC is unlikely).Prioritizing the most relevant internal and external influences based on an assessment of the ecosystem,as well as the market archetype.Definition of scenarios for the most relevant outcomes per influencing factor.Definition o

82、f high-level mitigation strategies with clear initial steps if the posed scenario develops.Definition of“no regret moves”and/or“quick wins”.We are not yet proficient at failing fast.The attitude of planning for the best,while ignoring the worst,creates significant blind-spots during development.”Ano

83、nymized:Executive commercialization of pipeline products top 20 PharmaCoOften,asset teams present to governing bodies just to secure resources or funding,or to update them on forecasts,which is too ritualized.We should learn to use governance entities,as well as peers in other asset teams,as soundin

84、g boards to broaden our viewpoint.”Anonymized:Executive commercialization of pipeline products top 20 PharmaCoStrategy&|Bridging Pharmas$200 million commercial gap20Strategy&|Bridging Pharmas$200 million commercial gap21Connection to resources,governance,and financial planningAs soon as the developm

85、ent plan outline is drafted,its vital that resources and budgeting are appropriately allocated.Scenarios and their respective evaluation/inflection points,in turn,need to be reciprocally connected to key functions,for instance:a.Financial forecasting.Changes within the ecosystem should automatically

86、 lead to updated assumptions and modified forecasts for optimized planning.b.Evidence generation.Certain scenarios(e.g.,regulatory or market access changes,as well as below-expectation efficacy read-outs)may require additional evidence to increase differentiation.c.Launch preparation and go-to-marke

87、t modeling due to ecosystem changes.One significant problem is that when some teams work on an asset for years,they lose sight of the overarching market developments.Too often,competitive intelligence personnel have not been empowered to act as a regular challenger.”Anonymized:Executive commercializ

88、ation of pipeline products top 20 PharmaCoWhile we are getting better at including commercial considerations earlier in the cycle,REAL scenario planning happens very late typically between Phases II and III.What we often lack are stronger regional and real-world evidence considerations during this s

89、cenario planning.”Anonymized:Executive commercialization of pipeline products top 20 PharmaCoCompetitive intelligence has been something of a sore point in our company since it was outsourced.Now,the assessment and integration of CI information during the various development steps depends entirely o

90、n the capabilities of the asset team leader.”Anonymized:Executive commercialization of pipeline products top 20 PharmaCoContinuous,tech-enabled monitoring Faster reaction to external events requires continuous monitoring of the entire drug development and go-to-market ecosystem.Particularly in the e

91、arly development phases,this will require a stronger commercial perspective,regional input,and associated functional presence.Additionally,asset teams will need to highlight evolving competitive influences to CI teams and in turn be informed about changes in competitive development programs ideally

92、via automated,tech-enabled processes.A strong collaboration between regional teams,CI,and the asset teams will allow for targeted adaptions to the primary development plan.Sufficient CI capabilities and resources will be necessary to ensure this level of interaction across multiple,simultaneous deve

93、lopment programs.New roles and responsibilitiesDepending on existing CI and asset team capabilities,new functions and roles will be required to ensure that nothing is left to chance.While not every asset will require a dedicated resource for Contingency Planning 2.0,highly strategic assets can benef

94、it considerably from the allocation of a dedicated“contingency lead”who works continuously as part of or alongside the asset team.Less strategically relevant assets,or those with lower market complexity,will still require a stronger commercial presence significantly earlier in the process,however.Th

95、e commercial viewpoint,combined with upscaled CI capabilities,should ensure sufficient monitoring to enable rapid adaptation in line with ecosystem changes,without a loss of focus on primary clinical development.Strategy&|Bridging Pharmas$200 million commercial gap23Strategy&|Bridging Pharmas$200 mi

96、llion commercial gap22ENDNOTESV.ConclusionWith the increasing pressure on R&D budgets,we believe that structured and optimally integrated contingency planning can systematically optimize protection against an assets downside position,or at least help PharmaCos to understand which assets should fail

97、fast due to market developments.Even an improvement of up to six months leading to longer peak sales would have a significant impact on R&D productivity.Such an increase would relate to“saved”sales of up to$75 million depending on the asset size,and an accelerated launch per asset typically up to fi

98、ve months earlier.Based on these numbers and the long-term cumulative effect of such gains,we believe that Contingency Planning 2.0 is a must-have for PharmaCos looking to improve their R&D productivity in the future.1.Strategy&analysis of Cowen and Company Pharmaceutical Industry Pulse(2000-2022)2.

99、Rome BD,et al.,Trends in Prescription Drug Launch Prices,2008-2021,JAMA.2022;327(21):2145-2147.doi:10.1001/jama.2022.55423.https:/www.eunethta.eu/about-eunethta/mission-vision-and-values/4.https:/www.bundesgesundheitsministerium.de/ministerium/gesetze-und-verordnungen/guv-20-lp/gkv-finanzstabilisier

100、ungsgesetz.html5.Closing Loopholes for Orphan Drug Act.(2020,December 23)117th Congress.6.https:/aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_Plan_9-9-Stay up to date Sign up here to receive the latest Strategy&thought leadership and industry trends 2023 PwC.All rights reserved.PwC refers t

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