morphosys ag meet the team · 2019-06-25 · morphosys ag meet the team the yale club, new york...
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MorphoSys AG
Meet The Team
The Yale Club, New York
June 25, 2019
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2© MorphoSys AG | Meet the Team | June 25, 2019
This presentation includes forward-looking statements.
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including its financial guidance for 2019,
the commencement, timing and results of clinical trials and release of clinical data both in respect of its proprietary product candidates and of product
candidates of its collaborators, the development of commercial capabilities, in particular with respect to tafasitamab (MOR208) and the transition of
MorphoSys to a fully integrated biopharmaceutical company, interaction with regulators, including the potential approval of MorphoSys’s current or future
drug candidates, including discussions with the FDA regarding the potential approval to market tafasitamab, the expected time of launch of tafasitamab,
and expected royalty and milestone payments in connection with MorphoSys’s collaborations. The forward-looking statements contained herein represent
the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results,
financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future
results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if
MorphoSys’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are
that MorphoSys’s expectations regarding its 2019 results of operations may be incorrect, MorphoSys’s expectations regarding its development programs
may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory
approval requirements (including that MorphoSys may fail to obtain regulatory approval for tafasitamab and that data from MorphoSys’s ongoing clinical
research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), MorphoSys’s
reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors
included in MorphoSys’s Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission. Given these uncertainties, the
reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of
publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any
change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may
affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or
regulation.
The compounds discussed in this slide presentation are investigational products being developed by MorphoSys and its partners and are not currently
approved by the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other regulatory authority (except for
guselkumab/Tremfya®). Any shown cross-trial comparison between MorphoSys-own investigational products and literature data have significant
limitations. Such data comparisons have been prepared at the request of, and for the sole benefit of, the investor community.
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3© MorphoSys AG | Meet the Team | June 25, 2019
David Trexler, President MorphoSys US Inc.
Meet the Team | June 25, 2019
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4© MorphoSys AG | Meet the Team | June 25, 2019
This presentation includes forward-looking statements.
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including its financial guidance for 2019,
the commencement, timing and results of clinical trials and release of clinical data both in respect of its proprietary product candidates and of product
candidates of its collaborators, the development of commercial capabilities, in particular with respect to tafasitamab (MOR208) and the transition of
MorphoSys to a fully integrated biopharmaceutical company, interaction with regulators, including the potential approval of MorphoSys’s current or future
drug candidates, including discussions with the FDA regarding the potential approval to market tafasitamab, the expected time of launch of tafasitamab,
and expected royalty and milestone payments in connection with MorphoSys’s collaborations. The forward-looking statements contained herein represent
the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results,
financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future
results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if
MorphoSys’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are
that MorphoSys’s expectations regarding its 2019 results of operations may be incorrect, MorphoSys’s expectations regarding its development programs
may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory
approval requirements (including that MorphoSys may fail to obtain regulatory approval for tafasitamab and that data from MorphoSys’s ongoing clinical
research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), MorphoSys’s
reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors
included in MorphoSys’s Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission. Given these uncertainties, the
reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of
publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any
change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may
affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or
regulation.
The compounds discussed in this slide presentation are investigational products being developed by MorphoSys and its partners and are not currently
approved by the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other regulatory authority (except for
guselkumab/Tremfya®). Any shown cross-trial comparison between MorphoSys-own investigational products and literature data have significant
limitations. Such data comparisons have been prepared at the request of, and for the sole benefit of, the investor community.
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5
Strong history of top level performance
© MorphoSys AG | Meet the Team | June 25, 2019
Commercial Leadership
David Trexler
President of MorphoSys US Inc.
33 year track record in building commercial capabilities
for international pharmaceutical companies
Prior positions as SVP Oncology Commercial for EMD
Serono/Merck KGaA building first commercial oncology
footprint in the U.S. and launching the first PD-L1
antibody for mMCC. Other positions, including Eisai Inc,
being responsible for commercial strategies, supporting
Aloxi®, Dacogen®, Halaven® and Lenvima®
Deep knowledge of marketing, sales, market access
environment and business development
Focus on build-up of MorphoSys’s commercial capabilities
in preparation for the planned tafasitamab launch
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6© MorphoSys AG | Meet the Team | June 25, 2019
We are building a strategic presence in
the world‘s most important pharmaceutical market
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1) IQVIA MIDAS May 2018 2) IQVIA patient survey June 2018
Accelerated market uptake from U.S. hub
© MorphoSys AG | Meet the Team | June 25, 2019
U.S. Commercialization Strategy
U.S. Market Size1)
64% of sales of all new medicines
launched between 2012-2017
48% of global sales (~$853 bn) in 2017
Large Oncology Network2)
Top 10 U.S. states contain 56% of all
DLBCL patients and 55% of all treaters
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Building the tafasitamab value chain between the U.S. and Europe
© MorphoSys AG | Meet the Team | June 25, 2019
Leveraging Synergies
Contributing strong commercial expertise
U.S. Head of Market Access and Policy
U.S. Marketing and Sales
U.S. Medical Affairs
Munich
Boston
MorphoSys AG
MorphoSys US Inc.
Contributing strong technology expertise
Global Head of Supply Chain Management
Global Head of Regulatory
Antibody material produced in Germany
Packaging of tafasitamab planned in Europe
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Laying a foundation for the anticipated launch of tafasitamab in the U.S.
© MorphoSys AG | Meet the Team | June 25, 2019
U.S. Commercial Strategy
Functional Commercial Structure
Filling critical positions by hiring talents with deep expertise
Targeted Market Access and Policy Approach
Securing timely and appropriate access to tafasitamab
>200
Commercial Operations Build-up
Providing an operational foundation to enable market access
Sales and Marketing Approach
Position tafasitamab as potential new standard of care
in r/r DLBCL
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Filling critical positions by hiring talent with deep expertise
© MorphoSys AG | Meet the Team | June 25, 2019
Functional Commercial Structure
Medical Affairs
Nuwan Kurukulasuriya
Market Access and Policy
Chris Mancill
Legal
Ben Looker
Finance
Chris Krawtschuk
Commercial Operations
Krishna Kadiyala
Sales and Marketing
Stephane Berthier
President
MorphoSys US Inc.
David Trexler
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Recruiting top talent to build a function fit for strong launch
© MorphoSys AG | Meet the Team | June 25, 2019
Top Talent
25 years experience in market access, policy,
and pricing at the global and U.S. levels
Prior positions with numerous biopharmaceutical
companies, including Amgen and EMD Serono/Merck KGaA
Proven track record of securing access for innovative
oncology products, matching the buy-and-bill, HCP-
administered profile of tafasitamab
Deep experience in oncology and hematology launches
across a large variety of indications and tumor types
Chris Mancill
Senior Vice President and Head
of Market Access and Policy
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HCP – Health care professionals CMS – Centers for Medicare & Medicaid
Striving to enable access to tafasitamab for all eligible patients
© MorphoSys AG | Meet the Team | June 25, 2019
Strategic Imperatives
Market Approach Policy Approach
Make tafasitamab easily available to HCPs
in community and academic settings
Ensure payer awareness through targeted pre-
approval engagement and secure CMS coding
Address barriers among HCPs to grant
timely patient access
Support appropriate patient access with financial
and other patient support resources
Brand MorphoSys as a responsible partner
in addressing policymaker’s priorities
Embed advocacy community perspectives
into the commercialization plan
Understand the pricing and reimbursement
landscape to inform launch plans
Ensure that stakeholder views are considered
in our patient access and support approach
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Recruiting top talent to build a function fit for strong launch
© MorphoSys AG | Meet the Team | June 25, 2019
Top Talent
14 years experience in creating value with
commercial operations and advanced analytics
Prior positions in a variety of biopharmaceutical
companies, including Spectrum, Novartis and Merck
Proven track record of developing commercial strategies
for maximizing short- and long-term value of the brand
Deep experience in oncology and hematology launches
across a variety of indications and tumor types
Krishna Kadiyala
Vice President and Head of
Commercial Operations and
Innovation
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Laying a solid operational foundation to enable market access
© MorphoSys AG | Meet the Team | June 25, 2019
Strategic Imperatives
Commercial building blocks
Enable sales and marketing to increase awareness
of tafasitamab among customers and patients
Implement cutting-edge technology and advanced
analytics to create competitive advantage
Deliver solutions to decrease barriers to adoption
Develop and continuously improve sales
management processes through innovation
Commercial Operations
Execute on roadmap for market segmentation
and sales force size and structure
Evaluate commercial technologies to enable
multiple sales and marketing touch points
Build commercial analytics function to shape
commercial strategy, life cycle management,
and resource allocation decisions
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Recruiting top talent to build a function fit for strong launch
© MorphoSys AG | Meet the Team | June 25, 2019
Top Talent
20 years experience in global and U.S. sales & marketing
and global research & development
Prior positions at Novartis and at Janssen where being
responsible for the Imbruvica® franchise
Strong scientific and business qualifications and proven
track record of leading sales & marketing teams and cross-
functional teams
Deep expertise in oncology and hematology with more
than 15 year experience in developing, launching and
maximizing drugs
Stephane Berthier
Vice President and Head of
Sales and Marketing
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1) Subject to approval HCP - Healthcare professionals
Establish tafasitamab as potential new standard of care in r/r DLBCL1)
© MorphoSys AG | Meet the Team | June 25, 2019
Strategic Imperatives
Sales and Marketing Approach
Support quick adoption of tafasitamab
at launch
Establish tafasitamab + lenalidomide as
potential standard of care in r/r DLBCL1)
Institute treat-to-progression in r/r DLBCL
Set up MorphoSys as a strong partner to key
oncology accounts and institutions
High performing field force communicates value of
tafasitamab and overcomes early access challenges
Tafasitamab + lenalidomide intended to allow for
convenient and long term disease control for
patients and HCPs
Tafasitamab + lenalidomide tolerability implies
potential benefit on long term treatment efficacy
Be seen by all stakeholders as a reliable
company caring for the needs of their patients
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17© MorphoSys AG | Meet the Team | June 25, 2019
Summary
Building-up of an efficient organization to prepare
for a potential U.S. launch of tafasitamab
Tapping the full potential of MorphoSys by addressing
the world’s most important pharmaceutical market
Creating an environment that attracts, develops
and retains best-in-class talent
SUMMARY