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Page 1: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Finance Concepts in Licensing

Page 2: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

FINANCE CONCEPTS IN LICENSING Valua%on  Methodology  

John  Selig,  Woodside  Capital  Partners  [email protected]

Building  a  Business  Development  Model  Philippe  Nore,  MiNDERA  

Materials  developed  by  Campbell  Alliance  [email protected]  

 

2

Page 3: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

The next sec%on of today’s discussion will be to arm you with knowledge  about the key data sources to use when building valua%on models and to  alert you to common mistakes that can occur along the way.  

Page 4: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

We will first provide you with the details of a hypothe%cal product that  will help guide today’s discussion.  

Page 5: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

As we think about the key inputs to building a valua%on model and the  data sources used to generate those inputs, it will be helpful to reference  a hypothe%cal product.  

§ Our hypothe*cal product, “Zaxxon,” is a molecule currently in development for moderate to severe Crohn’s  disease.  

§ It has the poten*al to be a very effec*ve medica*on, but it comes with some side effects that we can  assume will relegate it to always be a later-­‐line therapy.  

§ We expect this product to enter phase III trials in October 2015.  

§ For the sake of simplicity we will imagine that we are only interested in the poten*al value of this product  in the US.  

§ The drug is expected to be prescribed almost exclusively by specialists (gastroenterologists).  

§ Patent expira*on for Zaxxon is expected to occur in late 2025.  

Page 6: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

Revenue -­‐ -­‐ -­‐ 0.6 15.6 55.1 109.3 159.5 188.9 199.5 154.6 25.5 0.4

Sales  Costs -­‐ -­‐ -­‐ 8.9 9.4 9.8 10.3 10.9 11.4 12.0 12.6 -­‐ -­‐

Marke*ng  Costs 4.6 5.7 9.8 20.5 10.8 11.9 13.0 14.3 15.8 17.4 19.1 -­‐ -­‐

Cost  of  Goods  Sold -­‐ -­‐ -­‐ 0.1 1.6 5.5 10.9 16.0 18.9 19.9 15.5 2.5 -­‐

Development  Costs 25.7 25.7 5.1 2.0 -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐

Es*mated  Pre-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 27.9 75.1 118.3 142.8 150.2 107.4 23.0 0.4

Es*mated  Tax -­‐ -­‐ -­‐ -­‐ -­‐ 10.6 28.5 45.0 54.3 57.1 40.8 8.7 0.2

Es*mated  A]er-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 17.3 46.6 73.3 88.5 93.1 66.6 14.3 0.2

Discounted  Cash  Flow  (12%) (30.3) (28.0) (11.9) (22.0) (3.9) 9.8 23.6 33.2 35.8 33.6 21.4 4.1 0.1

Total  NPV 65.4

Our ini%al es%mates for Zaxxon show a peak-­‐year revenue of almost $200  million and a net present value of $65 million. We will now take %me to  understand some of the data sources that can go into such es%mates.  

Page 7: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Building a valua%on model requires you to make assump%ons for a  number of different forecast drivers.  

Page 8: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Model inputs can be divided into three segments: revenue, cost, and  other, which account for inputs that are neither revenue nor cost drivers.  

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l  l  l  l  l  l  l

Pa%ent flow    Product adop%on    Price of therapy    Reimbursement    Payer access    Length of therapy    Number of episodes  per year  

l  l  l  l  l  l  l  l

Development    Sales force    Pre-­‐launch marke%ng    Post-­‐launch marke%ng    Costs of goods sold    Rebates/discounts    NDA applica%on    Milestone payments  

l  l  l  l

Discount rate    Tax rate    Development risk    Launch %ming  

When developing valua%on models, it is important to remember that the  forecast es%mate is only as good as the assump%ons that go into it.  Significant %me must be invested in iden%fying appropriate data sources  that can support valid forecast assump%ons.  

Revenue  Inputs   Cost Inputs   Other  Inputs  

Page 10: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Our remaining %me will be focused on reviewing several key model inputs.  

Page 11: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Due to our limited %me we have focused our discussion on a few important  inputs that go into a valua%on model. For each, we will provide an overview,  highlight mistakes commonly made with the assump%on, and share helpful  data sources.  

Page 12: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

We will first explore three key drivers of a revenue forecast. The first  component we will discuss is pa%ent flow.  

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

Revenue -­‐ -­‐ -­‐ 0.6 15.6 55.1 109.3 159.5 188.9 199.5 154.6 25.5 0.4

Sales  Costs -­‐ -­‐ -­‐ 8.9 9.4 9.8 10.3 10.9 11.4 12.0 12.6 -­‐ -­‐

Marke*ng  Costs 4.6 5.7 9.8 20.5 10.8 11.9 13.0 14.3 15.8 17.4 19.1 -­‐ -­‐

Cost  of  Goods  Sold -­‐ -­‐ -­‐ 0.1 1.6 5.5 10.9 16.0 18.9 19.9 15.5 2.5 -­‐

Development  Costs 25.7 25.7 5.1 2.0 -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐

Es*mated  Pre-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 27.9 75.1 118.3 142.8 150.2 107.4 23.0 0.4

Es*mated  Tax -­‐ -­‐ -­‐ -­‐ -­‐ 10.6 28.5 45.0 54.3 57.1 40.8 8.7 0.2

Es*mated  A]er-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 17.3 46.6 73.3 88.5 93.1 66.6 14.3 0.2

Total  NPV 65.4

Page 13: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Specific Subgroup of Pa%ents  Who Are Candidates for This  

 Drug  

Segmenta%on  by    Line of Therapy  

A star%ng point for understanding the pa%ent flow is o`en the US census  popula%on data. From there, we then segment the relevant pa%ent  popula%on based on primary and secondary research.                        Overall Popula%on                Popula%on              Prevalence  Rate        Segmenta%on  by      Disease  Severity            Diagnosed  and            Treated  Rate  

Total Population in US 300M

Crohn’s Prevalence (.17%) 520K

Moderate to Severe Crohn’s Population (60%) 312K

Diagnosed and Treated Moderate to Severe Crohn’s Population (90%) 281K

Moderate to Severe Crohn’s Prevalence Not on 1st-Line Therapy (80%) 225K

Page 14: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Pa%ent  Flow  Component Common  Mistake Instead  You  Should…

Prevalence  Using  only  figures  cited  in  the  press,  by  pa*ent  advocacy  groups,  or  industry  par*cipants  

§  Combine  prevalence  es*mates  from  a  number  of  sources.  

§  Consider  the  poten*al  incen*ves  and  biases  of  par*cular  sources.    

§  Segment  the  pa*ent  universe  according  to  Zaxxon’s  product  profile.    

Segmenta%on  by  Disease  Severity  Including  pa*ents  whose  disease  severity  does  not  match  Zaxxon’s  profile  

Diagnosed  and  Treated  Rate  Including  all  pa*ents  with  a  condi*on,  not  just  those  whose  condi*on  warrants  treatment  by  a  physician  

Segmenta%on  by  Line  of  Therapy  Including  pa*ents  whose  treatment  status  does  not  match  Zaxxon’s  profile  

Using poten%ally biased sources and not pinpoin%ng  the appropriate  pa%ent popula%on can overes%mate Zaxxon’s product valua%on.  

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Secondary  Research

Primary  Research  With Appropriate  Stakeholders

Free  and  Publicly  Available    (Easy-­‐to-­‐use,  but  be  mindful  of  source  quality)

Syndicated  Data (One-­‐%me  purchases  or  subscrip%ons)

Data  Service  Companies (High  quality  but poten%ally  expensive)

•  Na*onal  Ins*tute  of  Health  website  [prevalence]  

• World  Health  Organiza*on  website  [prevalence]  

•  Journal  ar*cles  [prevalence,  segmentaBon,  diagnosed  and  treated  rate]  

•  Pa*ent  advocacy  websites  [prevalence]  •  SEC  filings  and  press  releases  of  compe*tors  [prevalence]  

•  NHANES  (CDC)  [prevalence]  •  SEER  database  (NIH)  [oncology  prevalence]  •  Na*onal  Hospital  Discharge  Survey  (CDC)  [prevalence]  

•  US  Renal  Data  System  (ESRD)  •  Interna*onal  Agency  for  Research  on  Cancer  [internaBonal  cancer  prevalence]  

Many  may  cover  some  or  all  dimensions  of  the  pa*ent  flow.    It  is  important  here  to  check  the  source  behind  the  source  and  to  cross-­‐reference  inputs  across  mul*ple  sources.  •  Datamonitor  •  Business  Insights  •  Decision  Resources  •  Analyst  reports  •  Kantar  Health  (oncology)  •  Some  journal  ar*cles  

Script  data  for  compe**ve  products  can  help  you  refine  and  validate  all  dimensions  of  the  pa*ent  flow.    •  IMS  Health  •  Truven  Health  Analy*cs  

Primary  research  with physicians  should  be  used  to  validate  findings  from secondary  sources  when possible.

There are a number of sources that can be consulted when construc%ng a  pa%ent flow. Ideally, each assump%on will be verified through mul%ple  sources.  

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We will next discuss key data sources for es%ma%ng product adop%on for  Zaxxon.  

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

Revenue -­‐ -­‐ -­‐ 0.6 15.6 55.1 109.3 159.5 188.9 199.5 154.6 25.5 0.4

Sales  Costs -­‐ -­‐ -­‐ 8.9 9.4 9.8 10.3 10.9 11.4 12.0 12.6 -­‐ -­‐

Marke*ng  Costs 4.6 5.7 9.8 20.5 10.8 11.9 13.0 14.3 15.8 17.4 19.1 -­‐ -­‐

Cost  of  Goods  Sold -­‐ -­‐ -­‐ 0.1 1.6 5.5 10.9 16.0 18.9 19.9 15.5 2.5 -­‐

Development  Costs 25.7 25.7 5.1 2.0 -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐

Es*mated  Pre-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 27.9 75.1 118.3 142.8 150.2 107.4 23.0 0.4

Es*mated  Tax -­‐ -­‐ -­‐ -­‐ -­‐ 10.6 28.5 45.0 54.3 57.1 40.8 8.7 0.2

Es*mated  A]er-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 17.3 46.6 73.3 88.5 93.1 66.6 14.3 0.2

Total  NPV 65.4

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Pa*e

nts T

reated

(in 000s)  

225  

90  

30   30  

75  100      50        0  

250    200    150  

Total Pa*ent Pool   Compe*tor A   Compe*tor B   Compe*tor C   Zaxxon  

A`er iden%fying the total poten%al pa%ent popula%on, we need to es%mate  the number of pa%ents for whom physicians will prescribe Zaxxon.            

 Crohn’s  Disease Compe%%ve  Landscape  

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Revenu

e (in

$M)  

154.6  

0.4  25.5  

199.5  188.9  

159.5  

109.3  

55.1  

15.6  0.6  

50      0  

150    100  

250    200  

2018   2019   2020   2021   2022   2023   2024   2025   2026   2027  

 Such an “S-­‐shaped” curve is commonly  used to forecast  drug          uptake. It is characterized by slow ini*al adop*on,  rapid        uptake  in subsequent  years, and a tailing  off as the product  nears peak penetra*on. It is commonly  assumed  that it takes      a product  five years a]er launch to get to peak penetra*on.  

 Important  to remember  is that    when valuing pharmaceu*cals,  You  must account  for the loss of      patent  protec*on.  

We must also assume an uptake curve for the adop%on of Zaxxon. In this  example we assume a five-­‐year sigmoid curve.            

 Zaxxon  Adop%on  Curve  

Page 19: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Even with primary market research with prescribing physicians, there are a  number of common mistakes that can drama%cally alter product valua%on.  

Common Mistake Instead You Should…

Ignoring compliance Do not forget to account for lost patients. A percentage of patients will experience insufficient efficacy and/or troublesome side effects with Zaxxon just as they do with other therapies.

Using an unrealistic product profile in market research

Share with physicians a target profile based on Zaxxon’s clinical data. Overestimating or underestimating Zaxxon’s efficacy, safety, and/or convenience can result in a misrepresentation of the drug’s value.

Not considering future competitors when assessing the future market for Zaxxon

When forecasting the future market for Zaxxon, remember to account for future entrants. In physician market research ask physicians about their potential use of Zaxxon in light of current and future competitors.

Unrealistic product adoption timeline

Base Zaxxon’s uptake curve on the unmet need and competitive environment of the market you are forecasting.

Page 20: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Es%mates for the adop%on rate should be grounded in primary market research  with prescribing physicians but can be validated through secondary research.  

Secondary Research

Primary Research with Appropriate Stakeholders

Free and Publicly Available (Easy to use but be mindful of source quality)

Syndicated Data (One time purchases or subscriptions)

Data Service Companies (High quality but potentially expensive)

§  SEC filings and press releases of competitors may provide historical and current sales of competitive products

§  If primary research is not feasible, an assessment of the competitive landscape and a comparison of competitive products against Zaxxon can be a starting point to estimating an adoption rate for Zaxxon

§  Some analyst reports §  FDA Orange Book [patent

life]

Analyst and industry reports can lay out the current competitive environment for Crohn’s disease, which can help you profile competitive products along with Zaxxon in your primary market research. Sources include: §  Datamonitor §  Decision Resources §  BCC Research §  Arrowhead Publishers §  Visiongain Intelligence §  Business Insights

Data companies, including Truven  Health  Analy*cs  and IMS, can provide historical sales trends on analog products that could enable you to construct adoption curves specific to Zaxxon.

Estimates for an adoption rate for Zaxxon should be generated through market research with appropriate physicians. Sharing Zaxxon’s product profile with physicians can give an early sense for their likely adoption once Zaxxon is launched.

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The final step in determining revenue is to es%mate the cost of therapy  and adjust for any poten%al payer restric%ons.  

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

Revenue -­‐ -­‐ -­‐ 0.6 15.6 55.1 109.3 159.5 188.9 199.5 154.6 25.5 0.4

Sales  Costs -­‐ -­‐ -­‐ 8.9 9.4 9.8 10.3 10.9 11.4 12.0 12.6 -­‐ -­‐

Marke*ng  Costs 4.6 5.7 9.8 20.5 10.8 11.9 13.0 14.3 15.8 17.4 19.1 -­‐ -­‐

Cost  of  Goods  Sold -­‐ -­‐ -­‐ 0.1 1.6 5.5 10.9 16.0 18.9 19.9 15.5 2.5 -­‐

Development  Costs 25.7 25.7 5.1 2.0 -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐

Es*mated  Pre-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 27.9 75.1 118.3 142.8 150.2 107.4 23.0 0.4

Es*mated  Tax -­‐ -­‐ -­‐ -­‐ -­‐ 10.6 28.5 45.0 54.3 57.1 40.8 8.7 0.2

Es*mated  A]er-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 17.3 46.6 73.3 88.5 93.1 66.6 14.3 0.2

Total  NPV 65.4

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Annu

al Cost o

f The

rapy

($)  

2,250  1,940  

2,485   2,400  

1,500    1,000      500        0  

2,500    2,000  

Product A   Product B   Product C   Zaxxon  

Looking  at  the  annual  treatment  costs of analog therapies is  a  good  star%ng  point.            

   Zaxxon  Cost of Therapy  Analogs        3,000  

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23

High-Level Pricing Definitions

We  need  to  know  the  price  of  a  drug  if  we  are  to  es%mate  its  revenue.    Be  aware  that  “price”  is  a  simple  word  with  mul%ple  meanings.  Price  may  be  expressed  in  terms  of  average  wholesale  price  (AWP;  “list”),  wholesale  acquisi%on  cost  (WAC;  “wholesale”),  and  Average  Selling  Price  (ASP;  “net”).    

We need to know ASP for the financial models. CMS (https://www.cms.gov/McrPartBDrugAvgSalesPrice/) now publishes ASP for drugs sold in the US.

AWP  

WAC,  ~80%  ASP,  ~75%  

Rebate,  ~15%  

Discount,  ~20%  

Discount,  ~20%  

0%  

10%  

20%  

30%  

40%  

50%  

60%  

70%  

80%  

90%  

100%  

List  Price   What  Wholesalers  

Pay  

What  Payers  Pay  

Share  of  AWP  

Manufacturers Net ASPWholesaler  discounts  are  typically  in  the  range  of  15%  to  20%  

(20%  shown).  

Payers  may  receive  substan*al  rebates    

(10%-­‐20%  in  compe**ve  markets).  

Payer

Wholesaler

Manufacturer

Discount

Rebate

ASP = AWP – Discounts – Rebates

Page 24: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Estimated Impact of Net Price on Formulary Access    

Pricing  and  Market  Access  Insights  can  be  developed  through  interviews  with  key  formulary  decision  makers  who  will  enable  you  to  assess  the  high-­‐level  rela%onship  between  price  and  formulary  access.    

70%   65%  

9%   4%  

30%   35%  

84%  

69%  

27%  

0%  

20%  

40%  

60%  

80%  

100%  

Price    Scenario  1  

Price    Scenario  2  

Price    Scenario  3  

Price    Scenario  4  

Percen

tage  of  P

lans  (Lives)  

Formulary/Preferred   Non-­‐Preferred   Not  Available/Restricted  

§  Key perspectives to test with payers:

Ø  Market access landscape

Ø  Access and restrictions at different price points and product profiles

Ø  Product adoption across different access scenarios

§  By covering a few targeted pricing scenarios (portraying multiple market conditions), we can derive the high-level tradeoffs in price and access.

Ø  A relatively small number of plans cover the majority of managed care lives.

Ø  Greater sample sizes would require including either extremely small plans or stakeholders without true formulary decision-making authority.

   

Page 25: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

Using inappropriate product analogs, ignoring price rebates, and not  taking into account the influence of generics are all common mistakes in  es%ma%ng price.  

Common Mistake Instead You Should…

Using the wrong analogs Make sure you identify appropriate analogs based on similar efficacy, safety, and method of administration.

Ignoring rebates Account for potential rebates in the sales price of your drug.

Not paying attention to the generic status of competitive products

Research the remaining patent life of competitive products. If one or more products go generic during your forecast period, it could have a dramatic impact on your pricing power.

Page 26: Finance Concepts in Licensing - BIO · Finance Concepts in Licensing . FINANCE CONCEPTS IN LICENSING Valua%on(Methodology ... about the key data sources to use when building valuaon

There are a number of poten%al sources to use to iden%fy poten%al analog  products for pricing and to find the prices for those analog products.  

Secondary Research

Primary Research with Appropriate Stakeholders

Free and Publicly Available (Easy to use but be mindful of source quality)

Syndicated Data (One time purchases or subscriptions)

Data Service Companies (High quality but potentially expensive)

§  Mail order prescription websites

§  Center for Medicare and Medicaid Services (CMS) – ASP Database

§  FDB First Databank §  Red Book (IMS Health) §  Epocrates.com (formulary

data) §  Medispan (formulary data) Syndicated publishers with pricing focused materials: §  Decision Resources §  Visiongain Intelligence

§  Medi-Span – Price Rx® / Wolters Kluwer – Can provide current and historic pricing information by product

Estimates for pricing and market access assumptions for Zaxxon should be generated through market research with appropriate formulary decision makers within payers (Regional/National Managed Care Organizations, Pharmacy Benefit Administrators, Medicare, Medicaid, etc.) . Sharing Zaxxon’s product profile with payers can give an early sense for their likely access restrictions at various price levels.

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Based on the Dealmakers’ Inten%on Survey, pricing analysis in addi%on to  physician analysis is becoming more of the norm when evalua%ng in-­‐  licensing opportuni%es.  

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28

Example  of  a  bad  revenue  analysis  from  a  Wall  Street  Analyst  

US Market 2012 2013E 2014E 2015E 2016E 2017E 2018E 2019E 2020E 2021E 2022E(All  figures  in  thousands  except  prices)# Patients eligible for treatment 3000%  Diagnosed  and  treated 20%#Patients actually treated 600 654 713 777 847 923 1,006 1,097 1,196 1,303 1,420Growth % 9% 9% 9% 9% 9% 9% 9% 9% 9% 9% 9%

% Market Share 0% 3% 6% 9% 12% 15% 15% 15% 15% 15%

#  Patients  treated 2 21 47 76 111 151 165 179 195 213

Cost per treatment (6 months) $2,887 $2,974 $3,063 $3,155 $3,250 $3,347 $3,447 $3,551 $3,657 $3,767Price Increase 3% 3% 3% 3% 3% 3% 3% 3% 3%

Cost  for  one-­‐year  treatment $2,887 $2,974 $3,063 $3,155 $3,250 $3,347 $3,447 $3,551 $3,657 $3,767

Total U.S. products sales $5,774 $63,601 $142,800 $240,491 $360,038 $505,193 $567,113 $636,803 $714,835 $802,607Growth YoY 1002% 125% 68% 50% 40% 12% 12% 12% 12%

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We will now discuss two important cost drivers: sales force costs and  development cost (and risk). We will first discuss development costs and  risks.  

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

Revenue -­‐ -­‐ -­‐ 0.6 15.6 55.1 109.3 159.5 188.9 199.5 154.6 25.5 0.4

Sales  Costs -­‐ -­‐ -­‐ 8.9 9.4 9.8 10.3 10.9 11.4 12.0 12.6 -­‐ -­‐

Marke*ng  Costs 4.6 5.7 9.8 20.5 10.8 11.9 13.0 14.3 15.8 17.4 19.1 -­‐ -­‐

Cost  of  Goods  Sold -­‐ -­‐ -­‐ 0.1 1.6 5.5 10.9 16.0 18.9 19.9 15.5 2.5 -­‐

Development  Costs 25.7 25.7 5.1 2.0 -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐

Es*mated  Pre-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 27.9 75.1 118.3 142.8 150.2 107.4 23.0 0.4

Es*mated  Tax -­‐ -­‐ -­‐ -­‐ -­‐ 10.6 28.5 45.0 54.3 57.1 40.8 8.7 0.2

Es*mated  A]er-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 17.3 46.6 73.3 88.5 93.1 66.6 14.3 0.2

Total  NPV 65.4

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There is no subs%tute for a detailed, line-­‐by-­‐line forecast of clinical trial  costs. However, when we lack a detailed forecast, we can use an  es%ma%on approach to forecast development costs.  

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To es%mate clinical costs, it is important to consider the therapeu%c area  of interest, the number of trials necessary, and the an%cipated length of  each trial.  

Phase I   Phase II   Phase III  

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Clinical success is by no means a sure thing. Forecas%ng clinical  development costs must also account for trial %meline and risk of failure.  Stages of Development

Source: Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Disc. 2004;3:711-715.

75    

34    

73    

86    

64  

42  

74  

94  

64  

40  

50  

67  67  

39  

67  

94  

60.3  

29  

41  

71  67  

38  

63  

90  

44   42  

70  

87  

48  

36  

66  

77  

39   39  45  

57  63  

39  

55  

76  

0  

10  

20  

30  

40  

50  

60  

70  

80  

90  

100  

Phase  I  to  Phase  II   Phase  II  to  Phase  III   Phase  III  to  NDA   NDA  to  Approval  

Average  Transi*

on  Probability  (%

)  

Arthri*s/Pain   Cardiovascular   CNS   Infec*ous  Disease   Oncology  

Ophthalmology   Metabolic  Disorders   Urology   Women's  Health   All  

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Common  Mistake   Instead  You  Should…

Failing  to  account  for  development  risk

In  your  model  you  need  to  account  for  the  scenario  where  the  drug  fails  overall,  elimina*ng  all  subsequent  cash  inflows  and  ouqlows.

Not  accoun%ng  for  poten%al  trial  failures,  especially  in  areas  with  high  placebo  response  rates

Failed  trials  s*ll  cost  money.  Account  for  the  possibility  that  your  drug  may  need  addi*onal  trials  to  account  for  failures  by  examining  the  trial  history  of  compe**ve  products.

Using  unrealis%c  development  %melines

The  *ming  of  cash  flows  is  important  in  a  valua*on  model,  par*cularly  in  the  early  years.  Be  sure  to  assume  a  reasonable  *meline,  including  for  regulatory  approval,  when  building  a  valua*on  model.

Not properly accoun%ng for development costs and risks can drama%cally  affect your valua%on model as these occur in the early years of the  forecast where valua%on is most sensi%ve.  

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There are several sources that may be used to help es%mate development  costs.  

Factor

Secondary Research Free and Publicly Available

(Easy to use but be mindful of source quality)

Syndicated Data (One time purchases or subscriptions)

Estimating average cost per patient

§  Internal company data §  Paraxel’s Pharmaceutical R&D

Statistical Sourcebook (provides data by phase and by therapeutic class)

§  Frost & Sullivan §  Datamonitor §  Kalorama Information §  Business Insights §  Center Watch

Estimating number of patients in trials

§  Internal company data §  NIH §  FDA Center for Drug Evaluation and

Research §  Clincalstudyresults.org §  Clinicaltrials.gov

Estimating development risk §  Internal company data §  NIH §  FDA Center for Drug Evaluation and

Research

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The more customized to your situa%on the bemer, but below are some  general industry data that you may consider using in the absence of  anything else.  

Factor

Secondary Research Free and Publicly

Available (Easy-to-use but be mindful of source

quality)

Syndicated Data (One-time

purchases or subscriptions)

Estimating average cost per patient

§  Internal company data §  Paraxel’s

Pharmaceutical R&D Statistical Sourcebook (provides data by phase and by therapeutic class)

§  Frost & Sullivan §  Datamonitor §  Kalorama Information §  Business Insights §  Center Watch

Estimating number of patients in trials

§  Internal company data §  NIH §  FDA Center for Drug

Evaluation and Research §  Clincalstudyresults.org §  Clinicaltrials.gov

Estimating development risk

§  Internal company data §  NIH §  FDA Center for Drug

Evaluation and Research

According to the NIH and FDA (as cited on the Mayo Clinic website), the following are estimates for trial sizes: P1 = 20-80 P2 = 100-300 P3 = 1000-3000

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The final cost driver we will discuss is sales and marke%ng costs.  

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

Revenue -­‐ -­‐ -­‐ 0.6 15.6 55.1 109.3 159.5 188.9 199.5 154.6 25.5 0.4

Sales  Costs -­‐ -­‐ -­‐ 8.9 9.4 9.8 10.3 10.9 11.4 12.0 12.6 -­‐ -­‐

Marke*ng  Costs 4.6 5.7 9.8 20.5 10.8 11.9 13.0 14.3 15.8 17.4 19.1 -­‐ -­‐

Cost  of  Goods  Sold -­‐ -­‐ -­‐ 0.1 1.6 5.5 10.9 16.0 18.9 19.9 15.5 2.5 -­‐

Development  Costs 25.7 25.7 5.1 2.0 -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐ -­‐

Es*mated  Pre-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 27.9 75.1 118.3 142.8 150.2 107.4 23.0 0.4

Es*mated  Tax -­‐ -­‐ -­‐ -­‐ -­‐ 10.6 28.5 45.0 54.3 57.1 40.8 8.7 0.2

Es*mated  A]er-­‐Tax  Cash  Flow (30.3) (31.4) (14.9) (30.9) (6.2) 17.3 46.6 73.3 88.5 93.1 66.6 14.3 0.2

Total  NPV 65.4

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It is important to first understand the concept of “deciling.” In sales force  forecasts, a prescribing universe is o`en broken down into deciles based  on prescribing levels.  

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A “reach and frequency” model can be used to es%mate sales force costs.  

Determined the typical fully-loaded field-force costs by market (and/or specialty) based on industry benchmarks

Determined number of relevant specialists by market to be targeted for Zaxxon

Determined the reach (i.e., How many deciles to target?) and frequency (i.e., How often to target these deciles?) based on internal company decisions

Allocated share of detail to Zaxxon (based on expected positioning within detail call)

Calculated the number of required reps and total detailing costs for Zaxxon

Audience US Gastroenterologists Total

Number of Specialists 11,864 11,864 Frequency of Details 15 for deciles 9-10;

10 for deciles 6-8 Total Details 71,184 71,184

Share of Cost to Product 100% 100%

Required Reps 84 84 Total Detailing Cost $16.8M $16.8M

Item Value Details per Day 4

Selling Days per Year 211

Details per Year per Rep 844

Cost per Year per Rep $200K

A

B

C

D

E Expected cost of field force

A B C

D E

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There are a number of common mistakes that can be made across the  different variables that go into a “reach and frequency” model.  

Common Mistake Instead You Should…

Not allocating the sales force costs across multiple products

If the sales force will be detailing multiple products to the same physicians, the sales force cost should be split accordingly.

Not using fully-loaded costs to estimate the cost of a salesperson

In addition to base salary and bonus, you must account for benefits. A rule of thumb is 2x salary and bonus to arrive at a “fully-loaded” cost.

Accounting for all physicians within a prescribing universe when forecasting sales costs

Typical sales efforts focus only on the top few prescribing deciles to get the highest return on investment. Include only those target physicians who are believed to be sales targets.

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There are several sources that can be consulted when building a “reach  and frequency” model to es%mate sales force costs.  

Factor

Secondary Research

Primary Research with Appropriate

Stakeholders

Free and Publicly Available (Easy to use

but be mindful of source quality)

Syndicated Data (One time

purchases or subscriptions)

Data Service Companies (High

quality but potentially expensive)

Determining fully-loaded field-force costs

§  Internet research (salary.com)

§  $150K-$250K is often used as fully-loaded cost

§  Cutting Edge Information

Potentially validate data through primary research

Determining number of relevant specialists to

be targeted §  AMA website

§  OECD website

(provides European data)

Determine reach and frequency

§  Internal assumption §  Cutting Edge Information

§  Verispan can provide data on sales force size

Potentially validate data through primary research

Allocate share of detail to Zaxxon

§  Internal assumption

A

B

C

D

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Assessing    other  marke%ng  costs  and  taking  into  account  new  trends  is  also  cri%cal  

•  Increasing number of physicians restrict access to sales reps

•  Reliance on eDetailing and digital marketing is increasing – Need to budget for this

•  Direct to consumer advertising can be very effective but is very expensive: make sure it is part of your forecast if it is going to be used

Product   Company     2014  DTC  Spend  

Cialis   Eli  Lilly   $248M  

Lyrica   Pfizer   $227M  

Eliquis   BMS/Pfizer   $219M  

Viagra   Pfizer   $211M  

Humira   AbbVie   $203M  

Latuda   Sunovion   $179M  

Xeljanz   Pfizer     $161M  

Celebrex   Pfizer     $119M  

Abilify     BMS   $108M  

Chan*x   Pfizer   $103M  

Source: MM&M DTC Report

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42

Example of a bad NPV analysis from a Wall Street Analyst

NPV  ModelAll  figures  in  thousands  (except  per  share  figures)Year 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022Product  sales   $5,774 $63,601 $142,800 $240,491 $360,038 $505,193 $567,113 $636,803 $714,835 $802,607Operating  expenses  (75%  of  sales) $4,331 $47,701 $107,100 $180,368 $270,029 $378,895 $425,334 $477,602 $536,126 $601,955Net  income  (25%  profit  margin) $1,444 $15,900 $35,700 $60,123 $90,010 $126,298 $141,778 $159,201 $178,709 $200,652Net  income*Likelihood  of  Success  (80%)  =  EAT: $1,155 $12,720 $28,560 $48,098 $72,008 $101,039 $113,423 $127,361 $142,967 $160,521NPV  of  EAT $377,536Cash  by  2Q13E $26,000Total  NPV $403,536NPV/Share $4.50

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As we close today’s presenta4on, there are a few important modeling best prac4ces to discuss.  

Modeling Best Prac%ces  

Managerial Recommenda%ons  

§  Make sure you understand the market environment  

§  Don’t overcomplicate the risk assessment (more on this on the next page)  

§  Compare the results of your model with current products and recent deals.  

 

§  

Modeling Recommenda%ons  

§  Use  a  standardized  model  template—star*ng  from  a  blank  spreadsheet  for  each  new  model  is  *me-­‐consuming  and  increases  the  poten*al  for  calcula*on  errors  

§  Avoid  hard  coding  values  in  formulas  

§  Use  standardized  formatng  conven*ons  that  clearly  differen*ate  user  input  from  model  calcula*ons  

§  Create  a  page  in  your  model  to  provide  references  for  important  inputs  

§  Create  a  dashboard  with  key  inputs  and  outputs  for  sensi*vity  analysis,  Data  Table  func*on  in  Excel  is  a  simple  way  to  do  sensi*vity  analysis  

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End