3 Nucleon - VRIO

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Veera K. Gonagundla Exhibit 2a: Resource-Based View (RBV Analysis) for the Core R&D Market & Biotech Manufacturing Resources Core Market (Biotech R&D) Biotech Manufacturing Assessment V R I O V R I O Genetic Engineering: Technical Competence Favors R&D Specific Competence: CRP Formula Favors Both Research Scientists Favors Both Strong Patent position on CRP Favors Both Financial Standing Favors R&D Ability to identify Therapeutic CRF Favors Both Specialized R&D Laboratories Favors R&D Mammalian Cell hosting technology Favors R&D Academic Partnerships Favors R&D Market Leadership in CRP Favors R&D Risk-taking attitude; motivation to expand Favors Both Relations with Venture Capitalists Favors R&D Market Size and presence of Demand Favors R&D Promising Pre-clinical trials Favors Both Overall, it is very clear the Nucleon has a unique expertise in R&D but no special expertise or resources or Competitive Advantage in Biotech Manufacturing industry.

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Transcript of 3 Nucleon - VRIO

  • Veera K. Gonagundla

    Exhibit 2a: Resource-Based View (RBV Analysis) for the Core R&D Market & Biotech Manufacturing

    Resources Core Market

    (Biotech R&D) Biotech Manufacturing Assessment

    V R I O V R I O

    Genetic Engineering: Technical Competence Favors R&D Specific Competence: CRP Formula Favors Both Research Scientists Favors Both Strong Patent position on CRP Favors Both Financial Standing Favors R&D Ability to identify Therapeutic CRF Favors Both Specialized R&D Laboratories Favors R&D Mammalian Cell hosting technology Favors R&D Academic Partnerships Favors R&D Market Leadership in CRP Favors R&D Risk-taking attitude; motivation to expand Favors Both Relations with Venture Capitalists Favors R&D Market Size and presence of Demand Favors R&D Promising Pre-clinical trials Favors Both

    Overall, it is very clear the Nucleon has a unique expertise in R&D but no special expertise or resources or Competitive Advantage in Biotech

    Manufacturing industry.

  • Veera K. Gonagundla

    Exhibit 2b: Resource-Based View (RBV Analysis) for all the expansion options

    Resources

    Pilot Plant for

    Phase 1 & 2

    Contract Mfg. for

    Phase 1 & 2

    Licensing for

    Phase 1 & 2

    Commercial Mfg.

    For Phase 3

    Licensing for Phase 3 & there

    on Assessment

    V R I O V R I O V R I O V R I O V R I O Needs improvement

    Genetic Engineering: Technical Competence Needs improvement Specific Competence: CRP Formula Promising Resource Research Scientists Promising Resource Strong Patent position on CRP Promising Resource Financial Standing Needs improvement Ability to identify Therapeutic CRF Promising Resource Specialized R&D Laboratories Favors in-house mfg. Mammalian Cell hosting technology Needs improvement Academic Partnerships Needs improvement Market Leadership in CRP Promising Resource Risk-taking attitude; motivation to expand Favors in-house mfg. Relations with Venture Capitalists Needs improvement Market Size and presence of Demand Promising Resource Promising Pre-clinical trials Promising Resource

    From the RBV Analysis, it is clear that the following are most promising resources of Nucleon for all the options of expansion:

    1. Technical competence: CRP Formula

    2. Research Scientists

    3. Strong Patent Position on CRP

    4. Ability to identify the Therapeutic CRF

    5. Market Leadership in CRP

    6. Market Size and presence of Demand

    7. Promising Pre-clinical trials

    These resources which are valuable, Rare, Inimitable and aligned with the Organization together forms the greatest competitive advantage for

    Nucleon for all the expansion options.

  • Veera K. Gonagundla

    Exhibit 3: TCE to assess the expansion decision:

    Features Biotech R&D Biotech Manufacturing

    Hierarchy Market Hierarchy Market

    Asset Specificity -----O----------------------- --------------------O------------

    Human Capital Specificity ---O------------------------- ------------O--------------------

    Location Specificity ---O------------------------- ----------------O----------------

    Quality Uncertainty --O-------------------------- ----O----------------------------

    Supply Uncertainty ---O------------------------- -----------------O---------------

    Post-Opportunistic Behavior issues ---O------------------------- -----------O---------------------

    Cost & frequency of interactions ---O------------------------- ---------------O-----------------

    IP issues & concerns ---O------------------------- -------O-------------------------

    Non-communicative issues (tacit) -----O----------------------- ------------O--------------------

    Financial Risk & availability -------------O--------------- -----------------------------O---

    Flexibility to Exit ---------------O------------- --------------------------O------

    Information Processing ---------------O------------- ---------------------------O-----

    Long-term Costs ----O------------------------ ------O--------------------------

    Freedom for expansion, decisions & rights ---O------------------------- ----O----------------------------

    Management Control & Costs ---O------------------------- ---------O-----------------------

    Technology Holdup costs --O-------------------------- ----O----------------------------

    Lemons Problem ---O------------------------- ------O--------------------------

    Coordinate internal & external operations ---O------------------------- ------O--------------------------

    Regulatory concerns ----------O------------------ -------------------------O-------

    Agency Costs -------------O--------------- -------------------------O-------

    Technology Transfer ---O------------------------- ----O----------------------------

    Marketing efforts -----------------O----------- -------------------------O-------

    ----------------------------- ---------------------------------

    Overall, it is clear that the R&D should be in-house and manufacturing should be outsourced or partnered with other corporations, who can

    provide the marketing efforts to Nucleons products.

  • Veera K. Gonagundla

    Exhibit 4: Options Available:

    Option 1: Pilot Plant & Commercial Manufacturing

    Option 2: Pilot Plant & Licensing

    Option 3: Contract Manufacturing & Commercial Manufacturing

    Option 4: Contract Manufacturing & Licensing

    Option 5: Complete Licensing

    Option 6: Licensing & Commercial Manufacturing (not possible & not available)

    Phase 1 & 2

    Pilot Plant Contract Manufacturing Licensing

    Phase 3 and Manufacturing

    Commercial Manufacturing Licensing(In-house Manufacturing)

  • Veera K. Gonagundla

    Exhibit 5: Complete Financial Analysis:

    Cost to obtain Phase -2 Clinical Trial Data for CRP-1

    Pilot Plant Contract Manufacturing

    7,394,000 4,795,000

    Estimated Gross Sales of CRP-1

    Year Sales

    1998 53,700,000

    1999 99,500,000

    2000 125,000,000

    2001 130,000,000

    2002 150,000,000

    2002 --> Future Assuming 10% discount rate and 5% increase in sales annually, the present value of total sales in future would be

    3,000,000

    Total 561,200,000

    Pilot Plant & Commercial Mfg

    Pilot Plant & Licensing

    Contracting & Commercial Mfg

    Contracting & Licensing Complete Licensing

    Cost for clinical trials 7,394,000 7,394,000 4,795,000 4,795,000 0

    Capital requirements 21,000,000 0 21,000,000 0 0

    Revenues on sale of CRP-1 224,480,000 56,120,000 224,480,000 56,120,000 28,060,000

    (40% of gross sales) (10% of sales as

    Royalties) (40% of gross sales) (10% of sales as

    Royalties) (10% of sales as

    Royalties)

    Up-Front Payments 0 7,000,000 0 7,000,000 3,000,000

    Totals 196,086,000 55,726,000 198,685,000 58,325,000 31,060,000

    Pilot Plant&

    CommercialMfg

    Pilot Plant& Licensing

    Contracting&

    CommercialMfg

    Contracting& Licensing

    CompleteLicensing

    Series1 196,086,000 55,726,000 198,685,000 58,325,000 31,060,000

    196,086,000

    55,726,000

    198,685,000

    58,325,000

    31,060,000

    0

    50,000,000

    100,000,000

    150,000,000

    200,000,000

    250,000,000

    Financial Analysis - Net Cash inflows

  • Veera K. Gonagundla

    Assumptions:

    The gross sales are expected to grow at 5% annually

    The Discount rate is assumed to be 10% (required to converge the perpetuity of gross revenues)

    The salaries of 20 persons are not taken into consideration (Assuming that might not affect the Commercial Manufacturing option much)

    All the costs are included, including the cost of acquisition and disposal of all physical & human resources for the estimate of cost of

    clinical trials

    The cost of capital, interest rates and VC funding (explicitly) is not included in the analysis

    VC funding is assumed to be included (implicitly) in the Capital requirements of $21 M (20 + 1)

    Exhibit 6: Options Evaluation:

    Options Strengths & Advantages & Opportunities Weaknesses & Disadvantages & Challenges

    Pilot Plant (for Clinical Trials in Phase 1 & 2)

    Favors future large-scale in-house manufacturing

    Experience with technical & regulatory issues is gained

    Good control over process & quality procedures during Manufacturing

    Easier to scale-up with the pilot plant in place

    CPR-1 has got several therapeutic applications

    Building manufacturing capability as a Competitive advantage as differentiating on R&D alone is difficult

    Plant is not useful for Phase 3 clinical trials

    No Financial capability to build such a plant

    No human resources & capabilities available

    Most drugs that entered clinical trials didnt reach the market

    Huge financial risk if the clinical trials are failed

    Process uncertainty: Bacterial cells or Mammalian cells for future hosting

    Company is only research-intensive and not manufacturing specialized

    Contract Manufacturing (for Clinical Trials in Phase 1 & 2)

    No major Capital investments required for clinical trials

    Contracts could be easily terminated

    Suppliers have facilities and personnel in place

    Ability to build relationships & partnerships with other companies

    The excess capacity of suppliers can be a negotiated for price

    Low risk with the failure of clinical trials

    Confidential information disclosure issues as the information is provided before contracting, for the sake of time & cost estimates

    Reaching an agreements takes several months

    Technology transfer & scaling-up takes upto 9 months

    Time to launch is critical

    Pricing uncertainty due to volume uncertainty

  • Veera K. Gonagundla

    Licensing (for Clinical Trials in Phase 1 & 2)

    Start the deal immediately for licensing and no future uncertainty

    No cost for Clinical development, manufacturing, regulatory filing, commercial manufacturing & marketing

    Receive up-front fixed licensing fee of $3M and any reimbursements applicable

    Low risk of failure of clinical trials

    Intended for partnerships

    Specialize in R&D activities with more focus

    No hassles and easy operations

    Lower revenues even if the clinical trials are successful

    Mortgaging away the companys future

    Less royalties as a percentage of sales (5%)

    Information sharing with the licensee is risky

    Commercial Manufacturing (For Phase 3 & then on)

    Huge profits of close to $200 M

    Best way to capture value for the formula

    Sole supplier to its Marketing partner

    Builds brand, reputation and corporate relationships

    Easy to raise the capital if the clinical trials are successful

    Huge capital investments of $21M is required

    No facilities & manufacturing expertise

    Build everything from the scratch

    High financial, operational & reputation risk if failed

    Investments need to be made even before the beginning of Phase 3

    Licensing (for Phase 3 & then on)

    No Capital requirements

    No financial risks

    Get $7M as an up-front payment

    Good partnerships and corporate relationships

    No responsibility for manufacturing and low marketing stake and efforts

    Low revenues with royalty payments of only 10%

    Information sharing with the licensee is risky