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Creating Hybrid CSO Models for Start-Up Operations
                     2 Case Studies




           Forum on Contract Sales Strategies for Bio/Pharmaceutical Companies
             Flexible Sales and Promotional Models for Enhanced Business Profitability
                                          June 21, 2011



        prepared  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
           Witte by Matthew Witte
損 MatthewMatthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Creating Hybrid CSO Models for Start-Up Operations
 - Presentation overview

 損 Hybrid Model Definition

 損 My Experience with Hybrid Models

 損 Why Pair Company Field Managers with CSO representatives?

 損 Case Study One  Ligand Pharmaceuticals

 損 Case Study Two  Somaxon Pharmaceuticals

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Hybrid Contract Sales Model
                        Definition
            A sales force build where the front line
            sales management are employed by the
            pharmaceutical company and the sales
             representatives are CSO employees.

        Note: In this model, the back office CSO support services
        can either be completely CSO managed or priced ala carte.

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
My Sales Teams Construction Bio

      損 Somaxon Pharmaceuticals
             Designed & staffed CNS hybrid CSO sales force

      損 Ligand Pharmaceuticals
             Designed & staffed Pain hybrid CSO sales force

      損 Roche Pharmaceuticals (Midwest Region)
             Built 3X3 mirrored primary care sales forces
             Initial build was designed as a hybrid CSO sales force model
             Multiple specialty team builds as Roche employees

      損 Novo Nordisk Pharmaceuticals
             Multiple specialty divisions from 1983-2004, all company employees

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Outsourcing Trends
   損 analysts see several trends continuing... with a
     move to reduce additional fixed costs through
     outsourcing.
           The Pharma Agenda: Hard Days Ahead, MedAdNews, January
           2010

   損 Companies are now looking to take sales force
     outsourcing to the next step.
        The New Sales Force, Pharmaceutical Executive, March 2009

   損 The first movers have changed their selling model
     and the traditional selling and promotion model is
     being redesigned.
        Tearing Up the Rule Book, Pharmaceutical Executive, February 2010

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Trend Toward Outsourced Sales
 - Fewer Company Reps, More Contract Specialty Reps

          Total Number of                                      Total Number of Outsourced
       Field Representatives                                      Field Reps Increasing
            Decreasing

                                                     12,000
                                                                                   100%
                                                     10,000                      Increase

             110,000                                  8,000                                     12,000
                                                                                               (16% of total)
              Total                                   6,000
                             ~75,000
              Reps                                                     6,000
                              Total                   4,000           (5% of total)
                              Reps
                                                      2,000

                                                         -
                                                                  2004-2005                 2015 Proj




損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Strategic Outsourcing
 - Why the Change to CSO Managed representatives?
 損 Efficiency
        Companies can focus on core
         competencies
        Outsource the rest


 損 Flexibility
        Quickly ramp up and/or down as the
         market demands
        Adjust the sales mix as needed


 損 Risk Mitigation
        Uncertainty, in todays world, is the
         norm
        Strategic outsourcing helps mitigate risk

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Strategic Outsourcing
 - Why Pair Company Managers with CSO representatives?
 損 Commitment to corporate results
        Company managers are tied tighter to corporate goals & objectives
        Typically incented with stock options
 損 Management talent
        Salaried at industry standards  increases recruitment pool
        More experienced, tenured specialty managers available
 損 Recruiting, screening and hiring
        Committed, enthusiastic managers pull in better sales candidates
 損 Strategic Management
        Focused on strategic & tactical issues, not sales bureaucracy
        Sales management without the mess

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Case Study One


              Ligand Pharmaceuticals Inc.


損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Ligand Pharmaceuticals Inc.
 - Company Overview
 損 San Diego based, drug development company whose current business
   model is specializing in royalty revenue generating assets
 損 Commercially marketed specialty pharmaceuticals from 1999 to 2007
 損 Ligand pre-commercial chronology:
        1987 - Progenx is formed
        1989  The company name is changed to Ligand Pharmaceuticals
        1992  The company goes public
        1995  Glycomed is acquired
        1998  Seragen is acquired
 Situation: Classic biotech R&D focused start-up without any commercial
    infrastructure

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Ligand Pharmaceuticals Inc.
 - Commercial History

        1999 - 2 products are FDA approved in the same week (Panretin gel
         and ONTAK)
        2000 - Commercial sales ramp up
        2001 - Targretin caps and gel are FDA approved and launched
        2002 - Avinza is acquired from Elan
        2002 - Avinza is FDA approved and launched
        2003 - Organon begins co-promoting Avinza
        2006 - Eisai acquires oncology products & personnel for $205MM
        2007  King acquires pain product & personnel for $313MM
        2007-date  Ligand continues as a royalty revenue company

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Ligand Pharmaceuticals
 - Multiple Roads to Commercial Products

 損 Acquires ligand retiniod R&D projects from Allergan in 1997
        Targretin  caps and gel
        Panretin  gel

 損 Acquires the company Seragen and assumes Interleukin 2-based
   targeted combination oncology projects
        ONTAK

 損 Acquires late stage product IND and marketing rights from Elan
   in 2002
        Avinza

 損 Ligand achieves FDA approval for all 5 products in 4 years

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Ligand Pharmaceuticals Inc.
 - Product Portfolio
 損 ONTAK (denileukin diftitox)
          Targeted oncologic, combination of IL 2 and diphtheria toxin
          Indicated for a rare indolent lymphoma - CTCL
          Deep frozen product
          Administered IV, similar to chemotherapy
          Price approx. $20K per cycle (2006)
 損 Targretin caps and gel (bexarotene)
        Retinoid, selectively targeting only X retinoid receptors
        Indicated also for CTCL
        Cost >$1K/month, depending on dosage formulation (2006)
 損 Avinza (morphine sulfate extended release capsules) CII
        Once-a-day formulation
        Flat PK profile

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Ligand Pharmaceuticals
 - Hybrid CSO model
 損 CSO provider  Innovex
 損 Ligands CSO goal  add scalable sales strength at the lowest
   possible cost per representative using existing internal sales
   support
 損 Contract details
        2001  initiated a CSO agreement for 20 full time dermatology contract sales
         representatives (managed by 4 existing Ligand oncology RSMs)
        2002  redirected these 20 reps to support the launch on Avinza
        2002  expanded the pain sales team to 50 reps, adding 30 additional full time
         CSO reps (managed by 5 Ligand Pain RSMs and a National Sales Director)
        2004  expanded the pain sales team to approx.100, by adding an additional
         50 CSO reps (expanding the Ligand RSMs to 10)

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Ligand Pharmaceuticals
 - Hybrid CSO model

 損 Innovex provided a National Field Director and Regional
   Field Coordinator allocated 50% to the Ligand contract

 損 Ligand RSMs were relieved of all traditional HR
   responsibilities due to co-employment rules

 損 All CSO back office services were ala carte (and virtually
   unused)

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Ligand Product Sales
                     $160



                     $140



                     $120
Product Sales ($M)




                                                                                                Ligand expands to
                                                                                                106 Specialty reps
                                                                           Avinza
                                                                       launches with
                     $100
                                                                         70 hybrid
                                                                       CSO Specialty
                                                                            reps
                     $80                 Oncology
                                                                                                                              Eisai
                                          40 reps
                                                                                                                              Deal

                                   Oncology         20 hybrid CSO                  Organon
                     $60                                                           Co-promotion
                                    20 reps           reps hired to
                                                                                     700 reps                                         King
                                                     launch T gel in
                                                                                                                                      Deal
                                                      dermatology
                     $40



                     $20



                      $0
                            1999          2000            2001            2002           2003            2004        2005     2006           2007


                                                                                        Year
                                    Avinza                   Ontak                     Targretin Caps                  T gel and Panretin
Ligand Sales
                     $225
                                                                                   3

                     $200                                                                Targretin
                                                                                   20
                                                                                         gel
Product Sales ($M)




                     $175                                                   4
                                                                                   32

                                                                            19
                     $150                                                                Targretin
                                                                            31           caps
                     $125                                            4


                                                                     15
                     $100
                                                                     32                  Ontak
                     $75                                                           150

                                                  4           3
                                                                            113
                     $50                   7
                                                  12          12

                                    3      15
                                                              24
                                                                     70                  Avinza
                     $25     2      7
                                                  27

                                           24
                                    13            12          17
                             8
                      $0
                            1999   2000   2001   2002        2003   2004   2005   2006

                                                      Year
Ligand Pharmaceuticals
 - Hybrid CSO Model Conclusions
 損 Goal:
          Scalable sales force
          Ability to shift deployment from Dermatology/Oncology to Pain, when needed
          Low cost per representative
          Use existing internal sales support
          Strong control of control, training, messaging, field activity, commitment through
           company employed RSMs
 損 Results:
        Sales force grew easily from 20 original reps and no additional RSMs to 106 reps in 10
         regions
        20 Derm reps formed the core of the initial 50 rep Pain sales team
        Cost per rep was minimized by using Ligands fledging sales support infrastructure
        Pain reps successfully launched Avinza into stiff competition, w/o a co-promotion
         partner, due in part to excellent field sales management

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Case Study Two


         Somaxon Pharmaceuticals Inc.


損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Somaxon Pharmaceuticals Inc.
- Company Overview
 損 San Diego based, commercially-focused company
 損 Formed in 2003, acquiring the marketing rights to low-dose doxepine (trade
   name Silenor) for sleep disorders
 損 Successfully executed an IPO in 2005
 損 Initial planned launch in 2008 abandoned after a FDA approvable letter
        Internal CommOps employees were released
        Plans to launch a 300+ sales force scrapped
 損 Final FDA division appeal resulted in Silenor approval in March 2010
        Internal staff down to 5 Executive Officers
 損 Silenor commercially launched in September 2010
 Situation: Specialty pharmaceutical start-up based on a re-purposed
    molecule and without any commercial infrastructure

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Somaxon Pharmaceuticals Inc.
 - Product Portfolio
 損 Silenor (doxepine)
        Indicated for the treatment of insomnia characterized by difficulty with sleep
         maintenance
        Silenor is approved for the treatment of both transient (short term) and chronic (long
         term) insomnia in both adults and elderly patients
        Silenor demonstrated maintenance of sleep into the 7th and 8th hours of the night, with
         no meaningful evidence of next day residual effects in clinical trials
        Silenor is not designated as a controlled substance by the U.S. DEA because of its
         demonstrated lack of abuse potential
        Price approx. $1 per day, with copay assistance the price to the consumer can be as
         low as $0.50
        Available as 3mg and 6mg dosage forms
 損 Sales Challenge
        Doxepin, originally launched as Sinequan by Pfizer in 1969, available as10mg generic

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Analysts Perspective

  We think Silenor has the best chance to become what many have tried
  and failed to achieve  the ideal insomnia drug. According to the FDA-
   approved label, Silenor carries no liability for dependence, addiction,
    tolerance, withdrawal, rebound, or next day residual effects yet still
  provides ideal efficacy for 8 hours. It is not DEA scheduled and works
   within the body's natural sleep-wake cycle; therefore it has a shot to
                  finally shake the "sleeping pill" stigma.
                      Jeffries & Company, Inc.; April, 2010


    Silenor carries what we find to be one of the most compelling labels
   among its competitors and will be the first insomnia drug to offer both
                 real efficacy and a lack of DEA scheduling.
                      Jeffries & Company, Inc.; April, 2010



損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Somaxon Pharmaceuticals Inc.
 - Hybrid CSO model
損 CSO provider  Publicis Touchpoint
損 Somaxons CSO goal  scalable sales force at premium per rep to
  build a medium-sized, fully supported specialty sales team
損 Contract details
       March 2010  FDA approves Silenor
       April 2010  Somaxon raises approx. $100MM to begin commercial scale-up
       May 2010  Hybrid CSO sales force model designed
       July 2010  10 Somaxon RSMs are hired, marketing team deployed
       August 2010  110 Publicis reps are hired
       August 2010  P&G co-promotion with 105 reps announced
       September 2010 - Silenor launched after 300+ national launch meeting
       March 2012  35 Publicis reps and 3 Somaxon RSMs added
損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Somaxon Pharmaceuticals
 - Hybrid CSO model

 損 Publicis initially provided a National Field Director and
   Regional Field Coordinator (RFC), allocated 100% to the
   Somaxon contract
 損 For the expansion, 2 additional RFCs were added
 損 Somaxon RSMs were relieved of all traditional HR
   responsibilities due to co-employment rules
 損 All CSO back office services were purchased


損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Somaxon Pharmaceuticals
 - Hybrid CSO Model Conclusions
 損 Goal:
          Scalable sales force, quick deployment
          Ability to shift deploy 110 initially and then build to approx. 250, when needed
          Premium cost per representative, competitive specialty base salaries
          Use full CSO back office sales support
          Strong control of control of sales training, messaging, field activity, rep commitment
           through company employed RSMs
 損 Results:
        Sales force grew easily from 110 original reps and 10 RSMs to 145 reps in 13 regions
        Premium cost per rep was justifiable considering no internal sales support
         infrastructure was required
        Sales reps average 6 years of specialty sales experience (90% CNS & 60% sleep)
        Publicis Touchpoint reps successfully launched Silenor in less than 4 months, also due
         in part to excellence field sales management

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
American Psychiatric Association Meeting
                  Silenor 20X20 Booth
                  Honolulu, Hawaii  May 2011

損 Matthew Witte  DesignPharma  Pharmaceutical Sales Operations & Analytics Consultants
Matt Witte\'s CBI Presentation on Building "Hybrid" CSO Sales Forces

More Related Content

Matt Witte\'s CBI Presentation on Building "Hybrid" CSO Sales Forces

  • 1. Creating Hybrid CSO Models for Start-Up Operations 2 Case Studies Forum on Contract Sales Strategies for Bio/Pharmaceutical Companies Flexible Sales and Promotional Models for Enhanced Business Profitability June 21, 2011 prepared DesignPharma Pharmaceutical Sales Operations & Analytics Consultants Witte by Matthew Witte 損 MatthewMatthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 2. Creating Hybrid CSO Models for Start-Up Operations - Presentation overview 損 Hybrid Model Definition 損 My Experience with Hybrid Models 損 Why Pair Company Field Managers with CSO representatives? 損 Case Study One Ligand Pharmaceuticals 損 Case Study Two Somaxon Pharmaceuticals 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 3. Hybrid Contract Sales Model Definition A sales force build where the front line sales management are employed by the pharmaceutical company and the sales representatives are CSO employees. Note: In this model, the back office CSO support services can either be completely CSO managed or priced ala carte. 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 4. My Sales Teams Construction Bio 損 Somaxon Pharmaceuticals Designed & staffed CNS hybrid CSO sales force 損 Ligand Pharmaceuticals Designed & staffed Pain hybrid CSO sales force 損 Roche Pharmaceuticals (Midwest Region) Built 3X3 mirrored primary care sales forces Initial build was designed as a hybrid CSO sales force model Multiple specialty team builds as Roche employees 損 Novo Nordisk Pharmaceuticals Multiple specialty divisions from 1983-2004, all company employees 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 5. Outsourcing Trends 損 analysts see several trends continuing... with a move to reduce additional fixed costs through outsourcing. The Pharma Agenda: Hard Days Ahead, MedAdNews, January 2010 損 Companies are now looking to take sales force outsourcing to the next step. The New Sales Force, Pharmaceutical Executive, March 2009 損 The first movers have changed their selling model and the traditional selling and promotion model is being redesigned. Tearing Up the Rule Book, Pharmaceutical Executive, February 2010 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 6. Trend Toward Outsourced Sales - Fewer Company Reps, More Contract Specialty Reps Total Number of Total Number of Outsourced Field Representatives Field Reps Increasing Decreasing 12,000 100% 10,000 Increase 110,000 8,000 12,000 (16% of total) Total 6,000 ~75,000 Reps 6,000 Total 4,000 (5% of total) Reps 2,000 - 2004-2005 2015 Proj 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 7. Strategic Outsourcing - Why the Change to CSO Managed representatives? 損 Efficiency Companies can focus on core competencies Outsource the rest 損 Flexibility Quickly ramp up and/or down as the market demands Adjust the sales mix as needed 損 Risk Mitigation Uncertainty, in todays world, is the norm Strategic outsourcing helps mitigate risk 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 8. Strategic Outsourcing - Why Pair Company Managers with CSO representatives? 損 Commitment to corporate results Company managers are tied tighter to corporate goals & objectives Typically incented with stock options 損 Management talent Salaried at industry standards increases recruitment pool More experienced, tenured specialty managers available 損 Recruiting, screening and hiring Committed, enthusiastic managers pull in better sales candidates 損 Strategic Management Focused on strategic & tactical issues, not sales bureaucracy Sales management without the mess 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 9. Case Study One Ligand Pharmaceuticals Inc. 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 10. Ligand Pharmaceuticals Inc. - Company Overview 損 San Diego based, drug development company whose current business model is specializing in royalty revenue generating assets 損 Commercially marketed specialty pharmaceuticals from 1999 to 2007 損 Ligand pre-commercial chronology: 1987 - Progenx is formed 1989 The company name is changed to Ligand Pharmaceuticals 1992 The company goes public 1995 Glycomed is acquired 1998 Seragen is acquired Situation: Classic biotech R&D focused start-up without any commercial infrastructure 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 11. Ligand Pharmaceuticals Inc. - Commercial History 1999 - 2 products are FDA approved in the same week (Panretin gel and ONTAK) 2000 - Commercial sales ramp up 2001 - Targretin caps and gel are FDA approved and launched 2002 - Avinza is acquired from Elan 2002 - Avinza is FDA approved and launched 2003 - Organon begins co-promoting Avinza 2006 - Eisai acquires oncology products & personnel for $205MM 2007 King acquires pain product & personnel for $313MM 2007-date Ligand continues as a royalty revenue company 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 12. Ligand Pharmaceuticals - Multiple Roads to Commercial Products 損 Acquires ligand retiniod R&D projects from Allergan in 1997 Targretin caps and gel Panretin gel 損 Acquires the company Seragen and assumes Interleukin 2-based targeted combination oncology projects ONTAK 損 Acquires late stage product IND and marketing rights from Elan in 2002 Avinza 損 Ligand achieves FDA approval for all 5 products in 4 years 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 13. Ligand Pharmaceuticals Inc. - Product Portfolio 損 ONTAK (denileukin diftitox) Targeted oncologic, combination of IL 2 and diphtheria toxin Indicated for a rare indolent lymphoma - CTCL Deep frozen product Administered IV, similar to chemotherapy Price approx. $20K per cycle (2006) 損 Targretin caps and gel (bexarotene) Retinoid, selectively targeting only X retinoid receptors Indicated also for CTCL Cost >$1K/month, depending on dosage formulation (2006) 損 Avinza (morphine sulfate extended release capsules) CII Once-a-day formulation Flat PK profile 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 14. Ligand Pharmaceuticals - Hybrid CSO model 損 CSO provider Innovex 損 Ligands CSO goal add scalable sales strength at the lowest possible cost per representative using existing internal sales support 損 Contract details 2001 initiated a CSO agreement for 20 full time dermatology contract sales representatives (managed by 4 existing Ligand oncology RSMs) 2002 redirected these 20 reps to support the launch on Avinza 2002 expanded the pain sales team to 50 reps, adding 30 additional full time CSO reps (managed by 5 Ligand Pain RSMs and a National Sales Director) 2004 expanded the pain sales team to approx.100, by adding an additional 50 CSO reps (expanding the Ligand RSMs to 10) 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 15. Ligand Pharmaceuticals - Hybrid CSO model 損 Innovex provided a National Field Director and Regional Field Coordinator allocated 50% to the Ligand contract 損 Ligand RSMs were relieved of all traditional HR responsibilities due to co-employment rules 損 All CSO back office services were ala carte (and virtually unused) 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 16. Ligand Product Sales $160 $140 $120 Product Sales ($M) Ligand expands to 106 Specialty reps Avinza launches with $100 70 hybrid CSO Specialty reps $80 Oncology Eisai 40 reps Deal Oncology 20 hybrid CSO Organon $60 Co-promotion 20 reps reps hired to 700 reps King launch T gel in Deal dermatology $40 $20 $0 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year Avinza Ontak Targretin Caps T gel and Panretin
  • 17. Ligand Sales $225 3 $200 Targretin 20 gel Product Sales ($M) $175 4 32 19 $150 Targretin 31 caps $125 4 15 $100 32 Ontak $75 150 4 3 113 $50 7 12 12 3 15 24 70 Avinza $25 2 7 27 24 13 12 17 8 $0 1999 2000 2001 2002 2003 2004 2005 2006 Year
  • 18. Ligand Pharmaceuticals - Hybrid CSO Model Conclusions 損 Goal: Scalable sales force Ability to shift deployment from Dermatology/Oncology to Pain, when needed Low cost per representative Use existing internal sales support Strong control of control, training, messaging, field activity, commitment through company employed RSMs 損 Results: Sales force grew easily from 20 original reps and no additional RSMs to 106 reps in 10 regions 20 Derm reps formed the core of the initial 50 rep Pain sales team Cost per rep was minimized by using Ligands fledging sales support infrastructure Pain reps successfully launched Avinza into stiff competition, w/o a co-promotion partner, due in part to excellent field sales management 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 19. Case Study Two Somaxon Pharmaceuticals Inc. 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 20. Somaxon Pharmaceuticals Inc. - Company Overview 損 San Diego based, commercially-focused company 損 Formed in 2003, acquiring the marketing rights to low-dose doxepine (trade name Silenor) for sleep disorders 損 Successfully executed an IPO in 2005 損 Initial planned launch in 2008 abandoned after a FDA approvable letter Internal CommOps employees were released Plans to launch a 300+ sales force scrapped 損 Final FDA division appeal resulted in Silenor approval in March 2010 Internal staff down to 5 Executive Officers 損 Silenor commercially launched in September 2010 Situation: Specialty pharmaceutical start-up based on a re-purposed molecule and without any commercial infrastructure 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 21. Somaxon Pharmaceuticals Inc. - Product Portfolio 損 Silenor (doxepine) Indicated for the treatment of insomnia characterized by difficulty with sleep maintenance Silenor is approved for the treatment of both transient (short term) and chronic (long term) insomnia in both adults and elderly patients Silenor demonstrated maintenance of sleep into the 7th and 8th hours of the night, with no meaningful evidence of next day residual effects in clinical trials Silenor is not designated as a controlled substance by the U.S. DEA because of its demonstrated lack of abuse potential Price approx. $1 per day, with copay assistance the price to the consumer can be as low as $0.50 Available as 3mg and 6mg dosage forms 損 Sales Challenge Doxepin, originally launched as Sinequan by Pfizer in 1969, available as10mg generic 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 22. Analysts Perspective We think Silenor has the best chance to become what many have tried and failed to achieve the ideal insomnia drug. According to the FDA- approved label, Silenor carries no liability for dependence, addiction, tolerance, withdrawal, rebound, or next day residual effects yet still provides ideal efficacy for 8 hours. It is not DEA scheduled and works within the body's natural sleep-wake cycle; therefore it has a shot to finally shake the "sleeping pill" stigma. Jeffries & Company, Inc.; April, 2010 Silenor carries what we find to be one of the most compelling labels among its competitors and will be the first insomnia drug to offer both real efficacy and a lack of DEA scheduling. Jeffries & Company, Inc.; April, 2010 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 23. Somaxon Pharmaceuticals Inc. - Hybrid CSO model 損 CSO provider Publicis Touchpoint 損 Somaxons CSO goal scalable sales force at premium per rep to build a medium-sized, fully supported specialty sales team 損 Contract details March 2010 FDA approves Silenor April 2010 Somaxon raises approx. $100MM to begin commercial scale-up May 2010 Hybrid CSO sales force model designed July 2010 10 Somaxon RSMs are hired, marketing team deployed August 2010 110 Publicis reps are hired August 2010 P&G co-promotion with 105 reps announced September 2010 - Silenor launched after 300+ national launch meeting March 2012 35 Publicis reps and 3 Somaxon RSMs added 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 24. Somaxon Pharmaceuticals - Hybrid CSO model 損 Publicis initially provided a National Field Director and Regional Field Coordinator (RFC), allocated 100% to the Somaxon contract 損 For the expansion, 2 additional RFCs were added 損 Somaxon RSMs were relieved of all traditional HR responsibilities due to co-employment rules 損 All CSO back office services were purchased 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 25. Somaxon Pharmaceuticals - Hybrid CSO Model Conclusions 損 Goal: Scalable sales force, quick deployment Ability to shift deploy 110 initially and then build to approx. 250, when needed Premium cost per representative, competitive specialty base salaries Use full CSO back office sales support Strong control of control of sales training, messaging, field activity, rep commitment through company employed RSMs 損 Results: Sales force grew easily from 110 original reps and 10 RSMs to 145 reps in 13 regions Premium cost per rep was justifiable considering no internal sales support infrastructure was required Sales reps average 6 years of specialty sales experience (90% CNS & 60% sleep) Publicis Touchpoint reps successfully launched Silenor in less than 4 months, also due in part to excellence field sales management 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants
  • 26. American Psychiatric Association Meeting Silenor 20X20 Booth Honolulu, Hawaii May 2011 損 Matthew Witte DesignPharma Pharmaceutical Sales Operations & Analytics Consultants