From start-up 1997 to NDA submission 2007 What comes next · 1 From start-up 1997 to NDA submission...
Transcript of From start-up 1997 to NDA submission 2007 What comes next · 1 From start-up 1997 to NDA submission...
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From start-up 1997 to NDA submission 2007What comes next !?!
Munich Network Technologietag 2007 27. Februar 2007
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Safe Harbor Statement
This presentation contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG, including summary statements relating to results of the SPARC trial and summary statements relating to the potential efficacy and safety profile of satraplatin. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this presentation. In particular, additional information relating to the safety, efficacy or tolerability of satraplatin may be discovered upon further analysis of data from the SPARC trial or analysis of additional data from other ongoing clinical trials for satraplatin. We cannot guarantee that satraplatin will be approved for marketing in a timely manner, if at all, by regulatory authorities nor that, if marketed, satraplatin will be a successful commercial product.
We direct you to GPC Biotech’s Annual Report on Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech does not undertake any obligation to update these forward-looking statements, even if new information becomes available in the future.
The scientific information discussed in this presentation related to satraplatin is preliminary and investigative. Satraplatin has not yet been approved by the FDA in the U.S., the EMEA in Europe or any other regulatory authority and no conclusions can or should be drawn regarding its safety or effectiveness. Only the relevant regulatory authorities can determine whether satraplatin is safe and effective for the use(s) being investigated.
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Agenda
• Company Highlights• Strategic Considerations in Building an Entrepreneurial Business• Corporate Development Path of GPC Biotech• Wrap-Up and the Future
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An Established Biotech Company With an Oncology Product in the FDA Registration Process
Martinsried/MunichMartinsried/Munich• Corporate headquarters• Research & development• ~120 employees
Waltham (Massachusetts)/ Princeton (New Jersey)
Waltham (Massachusetts)/ Princeton (New Jersey)
• Research & development• ~130 employees
• Founded in 1997 as a spinoff from the MPI for Molecular Genetics
• 2000: Acquired U.S. biotech Mitotix, Inc.
• IPO in 2000 on the Frankfurt Stock Exchange (Ticker: GPC)
• NASDAQ ADRs since June 2004 (GPCB)
• Market cap: ~€ 860m (>$1b)• Shares outstanding: ~35.8m• Indices: TecDAX, NASDAQ Health
Care Index
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Satraplatin
Multiple programs focused on kinase inhibitors and apoptosis inducers
Cell cycle inhibitors
Drug Discovery and DevelopmentDrug ProgramsPre-clinical development
Clinical development
Monoclonal antibody (1D09C3)
GPC Biotech has a Growing Oncology Drug Pipeline
Phase 1 Phase 2 Phase 3
Drug discovery
with Xeloda® in advanced solid tumors (x2)
2nd line treatment of HRPC (SPARC trial)
with radiation in non-small cell lung cancer
with Taxotere® in advanced solid tumors (x2)
relapsed/refractory B-cell lymphomas
refractory cancers
with Tarceva® in non-small cell lung cancer
with Xeloda® plus radiation in rectal cancer
with Gemzar® in advanced solid tumors
with Taxol® in non-small cell lung cancer
NDA filed
2nd line treatment of HRPC (SPARC trial)
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Agenda
• Company Highlights• Strategic Considerations in Building an Entrepreneurial Business• Corporate Development Path of GPC Biotech• Wrap-Up and the Future
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Strategy: Trying To Think Ahead
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Why is Strategy so Hard...?
…because there are no guarantees
...few important strategic issues are black and white
...only the test of time will separate the good from the bad
...luck plays an important part in determining outcome
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Important Strategic Parameters to Focus on in Building an Entrepreneurial Company
• People
• Networks
• Business Model
• Deals
• Board of Directors
• Milestone setting and communication
• Build-Up and exits
• Financing
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People (I)
No successful business is run by a single person...
...no matter how it may appear from the outside.
Companies need teams of like-minded and similarly motivated
individuals with complimentary skills.
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People (II)
Others
• Hire the absolutely best people you can get (even abroad if necessary)
• Don’t shy away from people who may be better than yourself
• Try to attract people that are a little bit of a stretch in terms of profile and
reputation
• Try to hire people before you have a need for their expertise
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Networks
“It‘s not what you know...
... but who you know.“ (not quite true, but almost)
• Business is done between individuals not corporations
- Most important deals are driven in part by personal relationships
- Trust is the most important factor in business interactions
- Relationships mostly need to be established well before a business
transaction can occur
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Business Models
“The right model for the right times“
• Markets change and business models need to keep up• Business models need constant review and adjustment, but cannot be
changed overnight• It takes 1 – 2 years minimum to re-orientate even a small biotech
business
- Ideally through pro-active planning not re-active measures
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Deals
“Deals drive businesses and generate value“
• The first deal is never the best (do not get too greedy early on!)• You learn by doing deals• Doing deals early builds the networks you need for later bigger and more
important deals
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Board of Directors
“Don‘t cut off the hand that feeds you...“
• Pro-actively build and maintain the best possible relationship
• Build the trust that will allow the Board to take a hands-off approach,
leaving the executives to run the company
• Pamper your board members…
- usually you need them more than they need you
- or they control a major chunk of your shares (VCs etc.)
• Keep the Board informed at all times of important strategic issues
- don’t spring surprises, good or bad
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Milestone Setting and Communication
• Set realistic milestones that are really meaningful to the business
• Manage the expectations of all your stakeholders- Employees, Board of Directors, VC investors, public investors…
• Don’t gloss over the uncertainty of your milestones- Knowledgeable stakeholders will accept failures provided the
expectations were set appropriately- Your personal integrity will stay in tact, and this is what you need to
keep running the business
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Build-Up and Exits (I)
“All investors require exits or else their business model fails“
• Pressure on the return on investment force ever more rapid build-up of businesses
• Exit opportunities from R&D programs drive exit opportunities for investors
- Tangible value from R&D is not generated until a viable exit opportunity is reached
• VCs and/or fund managers only invest in your company in order to make a return…alas, it is o.k. for them to sell at some point
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GenentechFounded
‘76
‘85
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‘01
‘02 ‘03 ‘04
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Build-Up and Exits (II): It Takes 10 Years
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Financing (I)
Sustainably profitable US biotech companies have one factor in common...
… they raised more than $500 Million before reaching profitability
• Raise as much money as possible and raise it not only when you need it
• Build relationships today with your investors of tomorrow
• Think carefully about which public market(s) to access
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Financing (II)
3,30,2
0,02,3
20,5
5,3
118,6
20,4
34,2 30,7
0,0
38,1
0,0
37,7
78,6
40,2
0,0
55,7
36,2
49,1(Q1-Q3)
33,6
0
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60
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100
120
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
Money Raised R&D Expenses
NASDAQ Listing
IPO Frankfurt
Private Placement
Hopp
Private Placement
Multi-Year Deal with ALTANA Pharma
1st VC Round
2nd VC Round
Mio. €
?
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Agenda
• Company Highlights• Strategic Considerations in Building an Entrepreneurial Business• Corporate Development Path of GPC Biotech• Wrap-Up and the Future
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Building GPC Biotech has at Times been a Rollercoaster (IPO until today)
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Quelle: Thomson Financials Datastream
IPO Frankfurt
Multi-Year Deal with ALTANA Pharma
In-licensing Satraplatin
Pivotal Phase 3 Trial
Initiated
NASDAQ Listing Phase 3 Trial fully
accrued
Topline Data Announced
Pharmion Licensing
Deal
NDA Submission
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GPC Biotech’s Development Path
• Phase 1 - Getting started as a technology platform company (1997)
• Phase 2 - Formulating and implementing long-term strategy for
sustainable growth (1998/99)
• Phase 3 - First rewards of strategy (1999)
• Phase 4 - Establishing GPC Biotech as a transatlantic public biotech
company (2000)
• Phase 5 - Advancing into clinical oncology (2001)
• Phase 6 - A Successful Drug Discovery, Development &
Commercialization Company?!
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Times were Different 9 Years Ago
Dilbert® by Scott Adams, © 1999 United Feature Syndicate, Inc.
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Phase 1 - Getting Started as a Technology Platform Company (1997)
Key Factors: Technologies & “Right” People
• Founded in late 1997 as spin-off from MPI of Molecular Genetics in Berlin
- Years of cutting-edge technology experience in high-throughput genomics & proteomics
• Key members of MPI department transfer to new company in Martinsried as founders
- All of them are still with GPC Biotech !
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Phase 1 - Getting Started as a Technology Platform Company (1997)
Key Factors: Financials & “Right” Environment
• Selection of first-class VCs with international experience - Deep pockets and connections (MPM / TVM)- High-caliber Supervisory Board
• Support from Qiagen (one of Europe’s most established and successful Biotech companies)
• Biotech “Gold Rush” in Germany - New wave of entrepreneurial spirit
• Unique and instrumental financial support from government for biotech start-ups – close to € 10M in support in first years !
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Phase 2 - Setting Long-Term Strategy for Sustainable Growth (1998/99)
• Intensive efforts to commercialize technology platform with Big Pharma- Generate cash and revenues for growth
• Drug discovery & development as final goal and ultimate upside potential - First drug discovery programs initiated in 1998
• Implementation of “dual business model”
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New Generation of Drugs
Dual Business Model
Strong upside potential
New Technologies: Focus on Drug
Discovery
Internal Drug Pipeline Focused
on Oncology
Pharma Alliances in Multiple
Therapeutic Areas
Strong upside potential
Revenues balance risk
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Phase 3 - First Rewards of Strategy (1999)
• Technology alliances with ALTANA, Aventis Pharma, Bayer AG, Boehringer Ingelheim
• Successful second round of financing in 1999 (€ 22 Million)
• Despite corporate success, continued significant role of government funding for select drug discovery programs
- Drug discovery still very low profile and high risk in 1999
• Established first small foothold in U.S. pharma cluster
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Phase 4 - Establishing a Transatlantic Public Biotech Company (2000)
• Acquisition of U.S. biotech company, Mitotix, Inc. (early 2000) in biotech cluster Boston/Cambridge
• Successful IPO on Frankfurt Stock Exchange (May 31, 2000): € 118.6M - Mitotix acquisition pre-requisite for “complete IPO story”
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Phase 5 - Advancing into Clinical Development (2001)
Why Change?
Why “Forward Integrate”?
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Pharmaceutical Industry is Increasingly Turning to Biotech to Fuel Growth
• More drugs developed by biotech than by pharma are being approved by the FDA
• Pharma’s increasing need for new products:
- Significant increase in the cost of in-licensing
- Increase in M&A value
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Phase 5 - Advancing into Clinical Development (2001)
• Pondering strategic options for “forward integration”
- M&A or internal organic expansion?
• Strategic decision to build internal infrastructure after attracting world-class head of drug development
• Princeton becoming headquarters for clinical development activities
• Strategic decision to focus on oncology
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Phase 6 – A Successful Drug Discovery, Development & Commercialization Company?!
Selling Drugs…
• FDA approval?
• Launch
• Sales
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Agenda
• Company Highlights• Strategic Considerations in Building an Entrepreneurial Business• Corporate Development Path of GPC Biotech• Wrap-Up and the Future
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My Lessons Learned as a GPC Biotech Founder: Good and Bad Habits of a (Biotech) Entrepreneur
Good habits:• Be a team player and only hire real first class people
(who are also team players)• Work only with first class people (VCs, Board, law firms, etc.)• Raise money not only when you need it• Do deals when you can• Be proactive, opportunistic, honest and think ahead
Bad habits:• Overestimate own capabilities• Founder syndrom
- Not going into second row- Not accepting change, particularly in company growth phases
(organic or M&A)
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Why Does Your Company Exist? – In the Eyes of Wall Street
• Exit strategy for VC
• Fee for banker
• Story for analyst
• Stock for a trader
• Near term opportunity for hedge funds
• Long term appreciation for mutual funds
• Opportunity for pharma
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Some Future Strategic Challenges for GPC Biotech
• Partner Satraplatin or go it alone?
• In-license Product Candidates?
• M&A to accelerate building of a Product Pipeline?
• Building of a Sales Force?
• Selling Satraplatin?
• Many, many more........
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The Future??? (I): GPC Biotech vs. US Big Biotechs (at 7-8 Years after Respective Startup)
GPC Biotech MedImmune Gilead IDEC
Founded 1997 1988 1987 1985
Data* as of 2003 1995 1994 1993
Revenue € 21.6M $14M $4M $12M
Cash ~ € 150M $48M $115M ~$50M
Burn Rate €27M $50M $33M $23M
# Employees 180 200 150 90
# Clinical programs 2 2 2 2
Market Cap ~ € 310M private private ~ $100M
IPO May 2000 Feb 1996 Feb 1996 Sep 1991
Market Cap (Feb. 2007) ~ € 857M ~ €5.935M ~ € 25.923M merged**
* GPC Biotech revenue and burn rate data for 2003; Cash as of after financing in June 30, 2004; **IDEC is BiogenIdec since Nov. 2003; market cap at June 30, 2003 ~ $6,977M
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The Future??? (II)
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The Future??? (III)
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From start-up 1997 to NDA submission 2007What comes next !?!
Munich Network Technologietag 2007 27. Februar 2007