Page | 1
Winning Necessary Resources for a
Successful Product Launch
Best Practices, LLC Strategic Benchmarking Research & Analysis
Page | 2
Executive Summary
Page | 3
Field Research & Insight Development:
Best Practices, LLC engaged 34 marketing and brand
leaders at 27 companies through a benchmarking
survey instrument.
Research participants worked in such functions as
marketing, commercial and product franchise.
• Identify Cost of Launching a
New Pharmaceutical Product
• Assess Timing & Impact of
Activity in Launch & Pre-Launch
• Top Success Factors for
Successful Pharmaceutical
Product Launch
Research Objectives & Methodology
Research Objectives:
 The objective of this benchmarking study is to help biopharma leaders develop competitive launch
and pre-launch activity budgets to ensure successful U.S. market entry for new products.
 This data will serve as a reference or comparison point for brand and marketing leaders as they
develop budgets and allocate funds for their new brands.
Business Objective:
Pharmaceutical companies can no longer afford to rely solely on past experiences when budgeting for a new
product launch in today's fast-changing, highly competitive market. This comprehensive benchmark study
investigates current costs as well as budget and staffing allocations required for a successful drug launch.
 Timing for conducting 50+ activities
 FTE Allocated to key launch activities
 Anticipated budget & activity trends
 Top 3 success factors
 Industry average cost for new pharmaceutical product
launch
 Average cost for multiple specialty, single specialty
and primary product launches
 Percentage of budget allocated to 12 key marketing,
education and market access activities during and
prior to launch
Page | 4
Universe of Learning: 27 Companies Contributed to this Research
This research engaged 34 marketing & commercial leaders from 27 leading pharmaceutical, biotech,
and life sciences companies. Eleven study participants represent large pharma organizations, while
the remaining benchmark class represent medium or small companies.
Benchmark Class:
Page | 5
Executive
VP /Vice
President
Senior
Director
Director
Manager
Others
Directors and Vice Presidents make up more than three-quarters of the benchmark class. A little under
half of the respondents work within marketing functions or departments.
Insights Drawn from Directors Working With Marketing & Market
Research Function
Q1. What is your current job title?
N=34
*Other research participants:
Consultant, Head of LCM & BD,
International Business Leader,
Head Commercial Strategy
*
Participant Job Titles Participant Departments/Functions
11%
7%
7%
7%
15%
19%
44%
Others
Medical Affairs
Commercial
New Product Planning
Theraputic Area BU
Market Research
Marketing
*
*Other research
participants: Prescription
Medicine, Life Cycle &
Global Strategy, Market
AccessN=27
41%
18%
21%
12%
9%
Page | 6
Launch Investment
Benchmarks
Research Protocol for Participants
 Focus all responses on a single product launched recently into the U.S.
market.
 Provide total investment for launch activities during four budget years
leading up to launch.
 Total investment is defined as: The total U.S. investment for pre-
launch/launch activities in a given budget year. Includes all resources
invested in promotional (marketing), educational and market access
activities. Excludes only clinical trial costs.
 Launch Year: The budget year in which the product was launched.
 Launch Years -1, -2 and -3: The budget years one, two and three years
prior to the Launch Year.
Page | 7
Primary care market entry and launch spend still sets the high-water mark and more closely reflect
launch patterns of the past decade. Specialty products take a more moderate approach throughout the
launch process.
Top-Level Spends in Each Year Driven by Primary Care Products
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
Total Benchmark
Class
Launch Year Launch Year -1 Launch Year -2 Launch Year -3
High $XXX $XXX $XXX $XXX
Top Quartile $XXX $XXX $XXX $XXX
Average (Mean) $XXX $XXX $XXX $XXX
Median $XXX $XXX $XXX $XXX
Bottom Quartile $XXX $XXX $XXX $XXX
Low $XXX $XXX $XXX $XXX
n= 22 22 14 14
Page | 8
Single Specialty care launches mirror the overall investment patterns reflected in the full benchmark
class with spend trending upward each year.
Single Specialty Launch Year Investment Averages $XX Million
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
N=39
Single Specialty Launch Year Launch Year -1 Launch Year -2 Launch Year -3
High $XXX $XXX $XXX $XXX
Top Quartile $XXX $XXX $XXX $XXX
Average (Mean) $XXX $XXX $XXX $XXX
Median $XXX $XXX $XXX $XXX
Bottom Quartile $XXX $XXX $XXX $XXX
Low $XXX $XXX $XXX $XXX
n= 12 12 8 7
Page | 9
Multiple specialty segment investments oscillate between $ 27 million and $ 2 million in the launch
year. Compared to launch year , launch year – 1 investment for this segment is higher by 61%.
Multiple Specialty Segment Launch Year Investment Averages $XX Million
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
N=39
Multiple Specialty Launch Year Launch Year -1
High
$XXX $XXX
Top Quartile
$XXX $XXX
Average (Mean)
$XXX $XXX
Median
$XXX $XXX
Bottom Quartile
$XXX $XXX
Low
$XXX $XXX
n= 3 3
Page | 10
Compared to other care areas companies invest highest in primary and specialty segment. Year on year,
the investments in this segment jump by 51%, 166% and 137% respectively in year – 2, year – 1 and
launch year.
Primary Care/Specialty Launch Year Investments Averages $XXX Million
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
N=39
Both Specialty And
Primary Care
Physicians
Launch Year Launch Year -1 Launch Year -2 Launch Year -3
High $XXX $XXX $XXX $XXX
Top Quartile $XXX $XXX $XXX $XXX
Average (Mean) $XXX $XXX $XXX $XXX
Median $XXX $XXX $XXX $XXX
Bottom Quartile $XXX $XXX $XXX $XXX
Low $XXX $XXX $XXX $XXX
n= 6 6 4 5
Page | 11
Investment Data by
Product Segment
Data is segmented by:
 Projected Peak Annual Revenue
 Type of Drug
 Product Launch Year
 Product Market Entry Position
 Therapeutic Areas – Oncology, Respiratory, Diabetes,
Cardiovascular
Page | 12
Peak-year revenue is one of the key metrics that helps companies determine corresponding market entry
budgets. Eighteen percent of respondents expect to achieve a peak revenue of more than $1 billion, while
36% of respondents foresee earning less than $250 million upon product launch. By contrast, in the 2011
study, 25% of companies projected more than a billion dollar in peak year revenue.
In Competitive Market, Predicted Peak Revenues Lower Than in the Past
Q10. What was the projected peak annual revenue for your product before launch?
N=33
Peak Annual Revenue Projection:
Under $250 M
$251 M-$500 M
$501 M-$750 M
$751 M to $1 B
$1.01 B - $1.5 B
$1.51 B - $2 B, 3%
More than $2 B
*
*
*Source: Best Practices, LLC’s 2011 Product Launch Spend Study
36%
18%
15%
12% 6%
9%
Page | 13
Data for Launch Year
Total Launch Investment by Peak Revenue Category:
N=39
Total Launch Investment by Peak Revenue Category
Data for Launch Year
PROJECTED PEAK
ANNUAL REVENUE:
LAUNCH YEAR
Projected Peak Revenue <=
$1Billion
Projected Peak Revenue >
$1Billion
Max
$XXX $XXX
Top Quartile
$XXX $XXX
Mean
$XXX $XXX
Median
$XXX $XXX
Bottom Quartile
$XXX $XXX
Min
$XXX $XXX
N=
17 4
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
Page | 14
On average, the total launch investment for differentiated products entering an established market was
higher by about $11 million during launch year than differentiated products in a novel treatment area.
Total Launch Year Investment
-- By Market Entry Position
N=39
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
MARKET ENTRY
POSITION: LAUNCH
YEAR
Differentiated Product In
Novel Treatment Area
Differentiated Product
Entering Established Market
Max
$XXX $XXX
Top Quartile
$XXX $XXX
Mean
$XXX $XXX
Median
$XXX $XXX
Bottom Quartile
$XXX $XXX
Min
$XXX $XXX
N=
5 15
Data for Launch Year
Total Launch Investment by Product Position at Market Entry
Page | 15
During launch year -1, the average investment for differentiated products entering an established market
is significantly higher than differentiated products in a novel treatment area.
Total Launch Year -1 Investment
-- By Market Entry Position
N=39
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
MARKET ENTRY
POSITION: LAUNCH
YEAR-1
Differentiated Product In
Novel Treatment Area
Differentiated Product
Entering Established Market
Max
$XXX $XXX
Top Quartile
$XXX $XXX
Mean
$XXX $XXX
Median
$XXX $XXX
Bottom Quartile
$XXX $XXX
Min
$XXX $XXX
N=
4 13
Data for Launch Year-1
Total Launch Investment by Product Position at Market Entry
Page | 16
Launch year -2 breaks the trend with a higher investment for differentiated products in novel treatment
area.
Total Launch Year -2 Investment
-- By Market Entry Position
N=39
MARKET ENTRY
POSITION: LAUNCH
YEAR-2
Differentiated Product In Novel
Treatment Area
Differentiated Product Entering
Established Market
Max
$XXX $XXX
Top Quartile
$XXX $XXX
Mean
$XXX $XXX
Median
$XXX $XXX
Bottom Quartile
$XXX $XXX
Min
$XXX $XXX
N=
4 8
Data for Launch Year-2
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
Total Launch Investment by Product Position at Market Entry
Page | 17
The average total launch investment for launch year -3 shows the investment for differentiated products
entering an established market is almost double the investment for differentiated products in a novel
treatment area.
Total Launch Year -3 Investment
-- By Market Entry Position
N=39
MARKET ENTRY
POSITION: LAUNCH
YEAR-3
Differentiated Product In Novel
Treatment Area
Differentiated Product Entering
Established Market
Max
$XXX $XXX
Top Quartile
$XXX $XXX
Mean
$XXX $XXX
Median
$XXX $XXX
Bottom Quartile
$XXX $XXX
Min
$XXX $XXX
N=
4 7
Data for Launch Year-3
Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch.
Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
Total Launch Investment by Product Position at Market Entry
Page | 18
Launch Activities
Benchmark partners were asked to indicate which launch
activities they fund within each of the following categories
during the last four budget years leading up to launch.
 Agency Fees (excluding DTC)
 Direct to Consumer & Advertising Expenses
 Health Economics/Outcomes Research
 Launch Meeting/Kickoff
 Managed Markets/Market Access
 Market Research/Analytics (excluding DTC)
 Medical Affairs
 Patient Education/Assistance
 Physician Education
 Sales Force Preparation
 Other
Page | 19
Public relation activities start from year – 3 and continue throughout the pre-launch and peaks at launch.
Promotional advertising starts in year – 2 and peaks at year – 1, while communication starts as early as
year – 3 and peaks at year – 2.
Public Relations Budgeted for Pre-Launch & Launch
Q. Please check all of the listed activities that were included in your product's Year -3, Year -2, Year -1 and Launch Year
budgets.
AGENCY FEES (excluding DTC)
11%
16%
79%
84%
84%
Other
Retainers
Communications/
Publications
Promotional/ Advertising
Public Relations
Pre-launch Launch Year
Year-3 Year-2 Year-1
50% 60% 65%
30% 60% 94%
80% 90% 82%
10% 20% 18%
10% 20% 18%
N=10 N=10 N=17 N=19
*Others: Website/Social Media platform Development(4), Strategy(2),
Competitive Landscape, market access and HEOR
*
=most frequent
activity per year
Page | 20
Physicians no longer wield all influence over market entry. Payers, HEOR, and Patients also are hotspots
for increasing launch investment. Medical Affairs also is on the rise.
HEOR & Managed Market Activities Expect Significant Funding
Increases
Q. How will recent and anticipated market changes impact funding levels for the following types of launch activities
over the next 24-36 months?
Activity Funding in a Changing Market:
3%
7%
10%
7%
7%
5%
20%
3%
34%
38%
14%
17%
17%
7%
13%
33%
7%
5%
27%
33%
48%
41%
59%
60%
37%
57%
47%
30%
66%
71%
43%
57%
14%
17%
24%
20%
Samples
Launch meeting (kickoff)
Sales force preparation
DTC
Agency fees (excluding DTC)
Other key activities
Physician Education/Market Shaping
Market research/analytics (excluding DTC)
Managed markets/market access
Health economics/outcomes research
Patient education/ assistance
Medical affairs/Medical Education
Significant increase Some increase About the same
77%
73%
79%
82%
36%
47%
10%
14%
40%
23%
14%
20%
Total Expecting Increase
N=21-30
*Others: HECOR, Mobile
communications, Advocacy
Activities
*
Page | 21
Launch Investment Allocation
 Participants indicated their total U.S. investment for pre-launch activities for their
respective product in four different budget years: Launch Year, Year -1, Year -2, and
Year -3.
 Budget numbers provided include all resources invested in promotional,
educational & market-access activities, excluding only clinical trial costs.
 Slides in this section exhibit average, top quartile and bottom quartile allocated for
activities in 12 categories for the Launch Year and the three years preceding launch.
 Data is provided for the full benchmark class. In addition, data is provided for the
following benchmark class segments: drug type, launch year, market entry position,
peak annual revenue projection, targeted physicians and therapeutic area.
Page | 22
Total Benchmark Class:
Launch Year & Launch Year -1
Investment Allocation by Activity Category (1)
Activity Category
Launch Year Year -1
Top Quartile Average Low Top Quartile Average
Bottom
Quartile
Agency Fees - excluding
DTC
$XXX $XXX $XXX $XXX $XXX $XXX
DTC Expenses $XXX $XXX $XXX $XXX $XXX $XXX
Health Economics/
Outcomes Research
$XXX $XXX $XXX $XXX $XXX $XXX
Managed Markets/ Market
Access
$XXX $XXX $XXX $XXX $XXX $XXX
Market Research/
Analytics - excluding DTC
$XXX $XXX $XXX $XXX $XXX $XXX
Medical Affairs/Medical
Education
$XXX $XXX $XXX $XXX $XXX $XXX
Patient Education/
Assistance
$XXX $XXX $XXX $XXX $XXX $XXX
Physician
Education/Market
Shaping
$XXX $XXX $XXX $XXX $XXX $XXX
Sales Force Preparation $XXX $XXX $XXX $XXX $XXX $XXX
All Other $XXX $XXX $XXX $XXX $XXX $XXX
Samples $XXX $XXX $XXX $XXX $XXX $XXX
Launch Meeting (kickoff) $XXX $XXX $XXX $XXX $XXX $XXX
N=20 N=20
Yellow highlights indicate highest three spend areas
for each year. Red circles indicate activities for which
Year -1 spend exceeds Launch Year investment.
Page | 23
Best Practices®, LLC is an internationally recognized thought leader in the field of best practice
benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that
conducts work based on the simple yet profound principle that organizations can chart a course to superior
economic performance by leveraging the best business practices, operating tactics and winning strategies of
world-class companies.
6350 Quadrangle Drive, Suite 200
Chapel Hill, NC 27517
(Phone): 919-403-0251
www.best-in-class.com
Learn More About Our Company:

Budget Allocation for a Successful Bio-Pharma Product Launch

  • 1.
    Page | 1 WinningNecessary Resources for a Successful Product Launch Best Practices, LLC Strategic Benchmarking Research & Analysis
  • 2.
  • 3.
    Page | 3 FieldResearch & Insight Development: Best Practices, LLC engaged 34 marketing and brand leaders at 27 companies through a benchmarking survey instrument. Research participants worked in such functions as marketing, commercial and product franchise. • Identify Cost of Launching a New Pharmaceutical Product • Assess Timing & Impact of Activity in Launch & Pre-Launch • Top Success Factors for Successful Pharmaceutical Product Launch Research Objectives & Methodology Research Objectives:  The objective of this benchmarking study is to help biopharma leaders develop competitive launch and pre-launch activity budgets to ensure successful U.S. market entry for new products.  This data will serve as a reference or comparison point for brand and marketing leaders as they develop budgets and allocate funds for their new brands. Business Objective: Pharmaceutical companies can no longer afford to rely solely on past experiences when budgeting for a new product launch in today's fast-changing, highly competitive market. This comprehensive benchmark study investigates current costs as well as budget and staffing allocations required for a successful drug launch.  Timing for conducting 50+ activities  FTE Allocated to key launch activities  Anticipated budget & activity trends  Top 3 success factors  Industry average cost for new pharmaceutical product launch  Average cost for multiple specialty, single specialty and primary product launches  Percentage of budget allocated to 12 key marketing, education and market access activities during and prior to launch
  • 4.
    Page | 4 Universeof Learning: 27 Companies Contributed to this Research This research engaged 34 marketing & commercial leaders from 27 leading pharmaceutical, biotech, and life sciences companies. Eleven study participants represent large pharma organizations, while the remaining benchmark class represent medium or small companies. Benchmark Class:
  • 5.
    Page | 5 Executive VP/Vice President Senior Director Director Manager Others Directors and Vice Presidents make up more than three-quarters of the benchmark class. A little under half of the respondents work within marketing functions or departments. Insights Drawn from Directors Working With Marketing & Market Research Function Q1. What is your current job title? N=34 *Other research participants: Consultant, Head of LCM & BD, International Business Leader, Head Commercial Strategy * Participant Job Titles Participant Departments/Functions 11% 7% 7% 7% 15% 19% 44% Others Medical Affairs Commercial New Product Planning Theraputic Area BU Market Research Marketing * *Other research participants: Prescription Medicine, Life Cycle & Global Strategy, Market AccessN=27 41% 18% 21% 12% 9%
  • 6.
    Page | 6 LaunchInvestment Benchmarks Research Protocol for Participants  Focus all responses on a single product launched recently into the U.S. market.  Provide total investment for launch activities during four budget years leading up to launch.  Total investment is defined as: The total U.S. investment for pre- launch/launch activities in a given budget year. Includes all resources invested in promotional (marketing), educational and market access activities. Excludes only clinical trial costs.  Launch Year: The budget year in which the product was launched.  Launch Years -1, -2 and -3: The budget years one, two and three years prior to the Launch Year.
  • 7.
    Page | 7 Primarycare market entry and launch spend still sets the high-water mark and more closely reflect launch patterns of the past decade. Specialty products take a more moderate approach throughout the launch process. Top-Level Spends in Each Year Driven by Primary Care Products Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. Total Benchmark Class Launch Year Launch Year -1 Launch Year -2 Launch Year -3 High $XXX $XXX $XXX $XXX Top Quartile $XXX $XXX $XXX $XXX Average (Mean) $XXX $XXX $XXX $XXX Median $XXX $XXX $XXX $XXX Bottom Quartile $XXX $XXX $XXX $XXX Low $XXX $XXX $XXX $XXX n= 22 22 14 14
  • 8.
    Page | 8 SingleSpecialty care launches mirror the overall investment patterns reflected in the full benchmark class with spend trending upward each year. Single Specialty Launch Year Investment Averages $XX Million Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. N=39 Single Specialty Launch Year Launch Year -1 Launch Year -2 Launch Year -3 High $XXX $XXX $XXX $XXX Top Quartile $XXX $XXX $XXX $XXX Average (Mean) $XXX $XXX $XXX $XXX Median $XXX $XXX $XXX $XXX Bottom Quartile $XXX $XXX $XXX $XXX Low $XXX $XXX $XXX $XXX n= 12 12 8 7
  • 9.
    Page | 9 Multiplespecialty segment investments oscillate between $ 27 million and $ 2 million in the launch year. Compared to launch year , launch year – 1 investment for this segment is higher by 61%. Multiple Specialty Segment Launch Year Investment Averages $XX Million Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. N=39 Multiple Specialty Launch Year Launch Year -1 High $XXX $XXX Top Quartile $XXX $XXX Average (Mean) $XXX $XXX Median $XXX $XXX Bottom Quartile $XXX $XXX Low $XXX $XXX n= 3 3
  • 10.
    Page | 10 Comparedto other care areas companies invest highest in primary and specialty segment. Year on year, the investments in this segment jump by 51%, 166% and 137% respectively in year – 2, year – 1 and launch year. Primary Care/Specialty Launch Year Investments Averages $XXX Million Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. N=39 Both Specialty And Primary Care Physicians Launch Year Launch Year -1 Launch Year -2 Launch Year -3 High $XXX $XXX $XXX $XXX Top Quartile $XXX $XXX $XXX $XXX Average (Mean) $XXX $XXX $XXX $XXX Median $XXX $XXX $XXX $XXX Bottom Quartile $XXX $XXX $XXX $XXX Low $XXX $XXX $XXX $XXX n= 6 6 4 5
  • 11.
    Page | 11 InvestmentData by Product Segment Data is segmented by:  Projected Peak Annual Revenue  Type of Drug  Product Launch Year  Product Market Entry Position  Therapeutic Areas – Oncology, Respiratory, Diabetes, Cardiovascular
  • 12.
    Page | 12 Peak-yearrevenue is one of the key metrics that helps companies determine corresponding market entry budgets. Eighteen percent of respondents expect to achieve a peak revenue of more than $1 billion, while 36% of respondents foresee earning less than $250 million upon product launch. By contrast, in the 2011 study, 25% of companies projected more than a billion dollar in peak year revenue. In Competitive Market, Predicted Peak Revenues Lower Than in the Past Q10. What was the projected peak annual revenue for your product before launch? N=33 Peak Annual Revenue Projection: Under $250 M $251 M-$500 M $501 M-$750 M $751 M to $1 B $1.01 B - $1.5 B $1.51 B - $2 B, 3% More than $2 B * * *Source: Best Practices, LLC’s 2011 Product Launch Spend Study 36% 18% 15% 12% 6% 9%
  • 13.
    Page | 13 Datafor Launch Year Total Launch Investment by Peak Revenue Category: N=39 Total Launch Investment by Peak Revenue Category Data for Launch Year PROJECTED PEAK ANNUAL REVENUE: LAUNCH YEAR Projected Peak Revenue <= $1Billion Projected Peak Revenue > $1Billion Max $XXX $XXX Top Quartile $XXX $XXX Mean $XXX $XXX Median $XXX $XXX Bottom Quartile $XXX $XXX Min $XXX $XXX N= 17 4 Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs.
  • 14.
    Page | 14 Onaverage, the total launch investment for differentiated products entering an established market was higher by about $11 million during launch year than differentiated products in a novel treatment area. Total Launch Year Investment -- By Market Entry Position N=39 Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. MARKET ENTRY POSITION: LAUNCH YEAR Differentiated Product In Novel Treatment Area Differentiated Product Entering Established Market Max $XXX $XXX Top Quartile $XXX $XXX Mean $XXX $XXX Median $XXX $XXX Bottom Quartile $XXX $XXX Min $XXX $XXX N= 5 15 Data for Launch Year Total Launch Investment by Product Position at Market Entry
  • 15.
    Page | 15 Duringlaunch year -1, the average investment for differentiated products entering an established market is significantly higher than differentiated products in a novel treatment area. Total Launch Year -1 Investment -- By Market Entry Position N=39 Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. MARKET ENTRY POSITION: LAUNCH YEAR-1 Differentiated Product In Novel Treatment Area Differentiated Product Entering Established Market Max $XXX $XXX Top Quartile $XXX $XXX Mean $XXX $XXX Median $XXX $XXX Bottom Quartile $XXX $XXX Min $XXX $XXX N= 4 13 Data for Launch Year-1 Total Launch Investment by Product Position at Market Entry
  • 16.
    Page | 16 Launchyear -2 breaks the trend with a higher investment for differentiated products in novel treatment area. Total Launch Year -2 Investment -- By Market Entry Position N=39 MARKET ENTRY POSITION: LAUNCH YEAR-2 Differentiated Product In Novel Treatment Area Differentiated Product Entering Established Market Max $XXX $XXX Top Quartile $XXX $XXX Mean $XXX $XXX Median $XXX $XXX Bottom Quartile $XXX $XXX Min $XXX $XXX N= 4 8 Data for Launch Year-2 Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. Total Launch Investment by Product Position at Market Entry
  • 17.
    Page | 17 Theaverage total launch investment for launch year -3 shows the investment for differentiated products entering an established market is almost double the investment for differentiated products in a novel treatment area. Total Launch Year -3 Investment -- By Market Entry Position N=39 MARKET ENTRY POSITION: LAUNCH YEAR-3 Differentiated Product In Novel Treatment Area Differentiated Product Entering Established Market Max $XXX $XXX Top Quartile $XXX $XXX Mean $XXX $XXX Median $XXX $XXX Bottom Quartile $XXX $XXX Min $XXX $XXX N= 4 7 Data for Launch Year-3 Q. Indicate your total U.S. investment for pre-launch activities for your product in the three years prior to the U.S. product launch. Include all resources invested in promotional, educational & market-access activities. Exclude only clinical trial costs. Total Launch Investment by Product Position at Market Entry
  • 18.
    Page | 18 LaunchActivities Benchmark partners were asked to indicate which launch activities they fund within each of the following categories during the last four budget years leading up to launch.  Agency Fees (excluding DTC)  Direct to Consumer & Advertising Expenses  Health Economics/Outcomes Research  Launch Meeting/Kickoff  Managed Markets/Market Access  Market Research/Analytics (excluding DTC)  Medical Affairs  Patient Education/Assistance  Physician Education  Sales Force Preparation  Other
  • 19.
    Page | 19 Publicrelation activities start from year – 3 and continue throughout the pre-launch and peaks at launch. Promotional advertising starts in year – 2 and peaks at year – 1, while communication starts as early as year – 3 and peaks at year – 2. Public Relations Budgeted for Pre-Launch & Launch Q. Please check all of the listed activities that were included in your product's Year -3, Year -2, Year -1 and Launch Year budgets. AGENCY FEES (excluding DTC) 11% 16% 79% 84% 84% Other Retainers Communications/ Publications Promotional/ Advertising Public Relations Pre-launch Launch Year Year-3 Year-2 Year-1 50% 60% 65% 30% 60% 94% 80% 90% 82% 10% 20% 18% 10% 20% 18% N=10 N=10 N=17 N=19 *Others: Website/Social Media platform Development(4), Strategy(2), Competitive Landscape, market access and HEOR * =most frequent activity per year
  • 20.
    Page | 20 Physiciansno longer wield all influence over market entry. Payers, HEOR, and Patients also are hotspots for increasing launch investment. Medical Affairs also is on the rise. HEOR & Managed Market Activities Expect Significant Funding Increases Q. How will recent and anticipated market changes impact funding levels for the following types of launch activities over the next 24-36 months? Activity Funding in a Changing Market: 3% 7% 10% 7% 7% 5% 20% 3% 34% 38% 14% 17% 17% 7% 13% 33% 7% 5% 27% 33% 48% 41% 59% 60% 37% 57% 47% 30% 66% 71% 43% 57% 14% 17% 24% 20% Samples Launch meeting (kickoff) Sales force preparation DTC Agency fees (excluding DTC) Other key activities Physician Education/Market Shaping Market research/analytics (excluding DTC) Managed markets/market access Health economics/outcomes research Patient education/ assistance Medical affairs/Medical Education Significant increase Some increase About the same 77% 73% 79% 82% 36% 47% 10% 14% 40% 23% 14% 20% Total Expecting Increase N=21-30 *Others: HECOR, Mobile communications, Advocacy Activities *
  • 21.
    Page | 21 LaunchInvestment Allocation  Participants indicated their total U.S. investment for pre-launch activities for their respective product in four different budget years: Launch Year, Year -1, Year -2, and Year -3.  Budget numbers provided include all resources invested in promotional, educational & market-access activities, excluding only clinical trial costs.  Slides in this section exhibit average, top quartile and bottom quartile allocated for activities in 12 categories for the Launch Year and the three years preceding launch.  Data is provided for the full benchmark class. In addition, data is provided for the following benchmark class segments: drug type, launch year, market entry position, peak annual revenue projection, targeted physicians and therapeutic area.
  • 22.
    Page | 22 TotalBenchmark Class: Launch Year & Launch Year -1 Investment Allocation by Activity Category (1) Activity Category Launch Year Year -1 Top Quartile Average Low Top Quartile Average Bottom Quartile Agency Fees - excluding DTC $XXX $XXX $XXX $XXX $XXX $XXX DTC Expenses $XXX $XXX $XXX $XXX $XXX $XXX Health Economics/ Outcomes Research $XXX $XXX $XXX $XXX $XXX $XXX Managed Markets/ Market Access $XXX $XXX $XXX $XXX $XXX $XXX Market Research/ Analytics - excluding DTC $XXX $XXX $XXX $XXX $XXX $XXX Medical Affairs/Medical Education $XXX $XXX $XXX $XXX $XXX $XXX Patient Education/ Assistance $XXX $XXX $XXX $XXX $XXX $XXX Physician Education/Market Shaping $XXX $XXX $XXX $XXX $XXX $XXX Sales Force Preparation $XXX $XXX $XXX $XXX $XXX $XXX All Other $XXX $XXX $XXX $XXX $XXX $XXX Samples $XXX $XXX $XXX $XXX $XXX $XXX Launch Meeting (kickoff) $XXX $XXX $XXX $XXX $XXX $XXX N=20 N=20 Yellow highlights indicate highest three spend areas for each year. Red circles indicate activities for which Year -1 spend exceeds Launch Year investment.
  • 23.
    Page | 23 BestPractices®, LLC is an internationally recognized thought leader in the field of best practice benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by leveraging the best business practices, operating tactics and winning strategies of world-class companies. 6350 Quadrangle Drive, Suite 200 Chapel Hill, NC 27517 (Phone): 919-403-0251 www.best-in-class.com Learn More About Our Company: