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Business Development And Its Information Needs. JJ Owen, AVEO Pharmaceuticals Bob Bennett, Merrimack Pharmaceuticals March 2007. Agenda. Introduction – Our Background Business Development Who and What do they do? Case Study: In-licensing Outputs and Sources

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business development and its information needs

Business Development And Its Information Needs

JJ Owen, AVEO PharmaceuticalsBob Bennett, Merrimack PharmaceuticalsMarch 2007

agenda
Agenda
  • Introduction – Our Background
  • Business Development
    • Who and What do they do?
  • Case Study: In-licensing
    • Outputs and Sources
  • Creating Value: Beyond the Sources
who is business development
Who is Business Development?
  • Small organization
  • Mostly MBA trained (some with science backgrounds)
    • Typically marketing or finance backgrounds
    • Prior background - consultants
  • Intimately aware of several data sources
    • Unaware of a large majority
  • Time crunched deadlines is the norm
  • Attention span of a gnat
  • Job focus & data source needs constantly changing
business development what do they do
Business Development – What do they do?

Mergers &

Acquisitions

Deal Negotiation

PublicRelations

Technical Writing

Financials

Market Analysis

CompetitiveIntelligence

Licensing Activity

Project Management

Competitive Landscape

Non-traditional activities

Traditional activities

in licensing has been described as
In-licensing has been described as…

…Finding a needle in a haystack

in licensing process flow
In-licensing: Process Flow
  • Finding Leads
  • Conferences
  • Connections
  • Secondary Sources
  • Primary Sources
  • Target Sweeps

Making the Case

  • Company Profiles
    • Key Personnel
    • Pipeline snapshot
    • Financials
    • Deals
  • Competitor Pipelines
  • Clinical Trial Data
  • Commercial Profile
    • Market Data

Tracking database

Pursue Opportunity

finding leads
Finding Leads
  • Attend conferences
    • AACR, ASCO, CHI, SRI, EORTC, many, many others
  • Connections
    • Who do you know?
  • Secondary Sources
    • Thomson Pharma, BioCentury, BioWorld, NewsFeeds, WWW
  • Primary Sources
    • Investors, SAB, BOD, Consultants
target sweeps
Target Sweeps

Akt inhibitors

Sources

Thomson Pharma, Company Websites, Newsfeeds

company profiles mgi pharma
Company Profiles - MGI Pharma

Overview

Pipeline

  • Headquarters: Bloomington, MN, Lexington, MA (MGI Biologics)
  • Therapeutic Focus: Entities (small molecule or Biologics) for cancer treatment and supportive care
  • Technology: BIOTOPE (targeted plasmid system) and GENCAP (DNA protection)
  • Strategy: Acquisition of clinical stage development compounds
  • Investors: Publicly traded on NASDAQ (MOGN)
  • Cash Position: $205.5M
  • Market Cap: $1.65 B ($1.65 B Enterprise Value)
  • Employees: 282
  • --Aloxi (licensed NA rights from Helsinn SA)
  • --Salagen (retains NA marketing rights)
  • --Hexalen (retains WW rights)
  • --Dacogen (Decitabine) (acquired WW rights from SuperGen)
    • Small molecule, DNA methyltransferase inhibitor
    • P3 mono, MDS, 170 pts: RR 17% vs. 0% for supportive care
    • P2 mono, Gleevec ref. CML, 27 pts: 17 hema. response
  • --Irofulven (retains WW rights)
    • Small molecule acylfulvene, breaks DNA strands
    • P2 mono, rel/ref Ovarian, 55 pts: 1 CR, 9 PR
    • P3 mono, ref Pancreatic: OS inferior to 5-FU
    • P2 with ERCC3 gene deficient pts underway
    • P2 mono, liver, 48 pts: 2 PR, 18 SD
  • --Saforis (retains WW rights), Phase III, mucositis
  • --ZYC101a (acquired in purchase of ZYCOS )
    • Antibody, completed Phase II, 161 pts, RR 43% vs. 27%, drug was well tolerated
  • --ZYC300 (acquired in purchase of ZYCOS)
    • Antibody, completed Phase I/II, 17 pts, ASCO 2003, drug was well tolerated and biologically active
  • --MG98 (licensed NA rights from Methylgene)
    • Antisense oligonucleotide, inhibits DNA methyltransferase-1
    • P2 RCC, IFN combo: Initiated 10/04

Sources

--Thomson Pharma, Recap, Company website, Yahoo Finance, SEC

Recent News

4/05: MGI PHARMA Reports First Quarter Results

1/05: Dacogen NDA filing for MDS accepted by FDA

12/04: Dacogen P3 trial results in MDS reported at ASH

10/04: Dacogen MAA filing for MDS accepted by EMEA

9/04: Begins promotion of Kadian to oncologists

9/04: Acquires WW marketing rights for Dacogen from SuperGen

9/04: Acquires Zycos for $50 M in cash

9/04: Acquires Aesgen for $90 M in cash

7/04: Kadian marketing agreement for oncology market with Alpharma

mgi pharma
MGI Pharma

Personnel

Financials

Income Statement (12/31/2004)

Revenues $195.7 M

COGS 60.0 M

R&D Expense 62.6 M

SG&A Expense 73.8 M

Acq. R&D Expense 83.1 M

Operating Income (84.7 M)

Interest Income 5.3 M

Interest Expense (6.0 M)

EBT (85.4 M)

Balance Sheet (12/31/04)

Assets:

Cash and Equivalents 205.5 M

Accounts Receivable 122.3 M

Inventories 8.4 M

Other Current Assets 5.8 M

LT Investments 75.4 M

Property, Plant and Equipment 2.7 M

Intangible Assets 8.0 M

Total Assets 436.3 M

Liabilities:

Current Liabilities 58.8 M

Long Term Debt 260.2 M

Other Liabilities 2.8 M

Total Liabilities 321.8 M

Shareholders Equity:

Net Shareholders Equity 114.5 M

Total Liabilities and SH Equity 436.3 M

mgi pharma15
MGI Pharma

Deals

  • 9/04: Acquires privately held Zycos for $50 M in cash
    • Acquires expertise in immunology and development of biologics
    • See Pipeline for clinical data
  • 9/04: Acquires privately held Aesgen for $32 M in cash
    • Pays $32 M upfront, milestones of $33 M for approval and $25 M if annual sales exceed $50 M plus royalty of 5%
    • Acquires Saforis, a P3 compound for oral mucositis
  • 9/04: Licenses WW rights to Dacogen from SuperGen
    • P3 completed in MDS with an NDA expected 4Q04
    • Possible expansion into AML, CLL and solid tumor
    • Pays $40 M equity investment, up to $45 M in milestones, at least $15 M in development costs and royalty from 20-30%
  • 7/04: Kadian marketing agreement with Alpharma
    • Kadian is a sustained release morphine marketed for pain relief
    • 3 yr agreement for MGI to market Kadian to oncologists
    • Undisclosed profit sharing agreement
  • 4/01: Licenses NA commercialization rights for Aloxi from Helsinn
    • Aloxi is a P3 product for chemotherapy induced nausea and vomiting
    • Pays $11 M upfront, undisclosed milestones and royalties
    • Helsinn funds development and responsible for manufacturing
    • 4/03: Collaboration expanded to include post-operative nausea and vomiting indication and an oral formulation
    • Pays $22.5 M upfront and up to $25 M in milestones
  • 1/01: US marketing rights for Mylocel from Barr Labs
    • Mylocel (hydroxyurea) marketed for melanoma, CML and ovarian cancer
    • Barr receives undisclosed royalties
competitive landscape late stage breast cancer targeted therapies
Competitive Landscape: Late Stage Breast Cancer Targeted Therapies

Sources

--Thomson Pharma

--Clinicaltrials.gov, ASCO abstracts, DataMonitor

market analysis breast cancer epidemiology and current treatment paradigm 2004
Market Analysis: Breast Cancer Epidemiology and Current Treatment Paradigm, 2004

Incidence Prevalence Mortality 1 yr survival 5 yr survival

412,894 2,714,400 121,197 97.5% 86.5%

Current Treatment Paradigm

Sources

--DataMonitor, WWW, GloboCan, American Cancer society, NCI

Late Stage

Early Stage

  • Options dependent on status
  • Chemotherapy
    • -Paclitaxel and Docetaxel
  • Hormonal Therapy
    • -Tamoxifen or Arimidex
  • Targeted Therapy
    • -Herceptin (Her2+ only, 25% of patients)

Surgery

*depends on hormone receptor and menopausal status

business development sources
Business Development Sources
  • Extremely limited resources, always looking for the best “bang for your buck”
  • Choice of source is critical when one has money
  • Public sources, public sources, public sources
  • Current Gaps
    • Sales projections
    • Analyst reports
    • Clinical trial data
    • Deal details
slide19

Articulating the value of

information and analysis

how is information analysis delivered in your organization
How Is Information & Analysis Delivered In Your Organization?

Newsletters

Literature Alerts

Conference Reports

Interactions with individuals

Membership on project teams

On-line requests

Journal subscriptions

Department webpage

Provide access to databases

value is created in each step of the process
Value Is Created In Each Step Of The Process

Access

Greater breadth of information sources

Timeliness

Rapid access to information through knowledge, effective searching, and alerts

Subject

Knowledge

Cut through the noise, recognize critical info, provide analysis, deliver exec summaries

Delivery

Multitude of delivery mechanisms

Reduce time to customer

how would an information professional assist bus dev
How Would An Information Professional Assist Bus Dev?
  • Added Knowledge

Sources, limitations, and effective use

  • Focused Data

Quality, accuracy, completeness, analysis

  • Efficient Use Of Time

Division of labor

  • Assist In Budgeting

Able to forecast information needs as company matures

slide27
JJ Owen:

AVEO Pharmaceuticals

jjowen@aveopharma.com617.299.5889

Bob Bennett:

Merrimack Pharmaceuticals

rbennett@merrimackharma.com617.441.1008

Thank you