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1© MorphoSys AG | Meet the Team | June 25, 2019
Engineering the Medicines of Tomorrow
Simon Moroney, Chief Executive Officer
Meet the Team | June 25, 2019
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.
3
Effective on September 1, 2019
© MorphoSys AG | Meet the Team | June 25, 2019
New CEO Dr. Jean-Paul Kress
Over 20 years in the pharmaceutical and
biotechnology industry, with a strong track record
of commercial and operational leadership in North
America and Europe
Prior senior management roles include
Syntimmune: Chief Executive Officer
Biogen: Executive Vice President and Head of
Global Therapeutic Operations
Sanofi: Senior Vice President, Head of North
America at Sanofi Genzyme
Sanofi Pasteur MSD: President, CEO
Gilead: General Manager, France, and member
of the operating committee
Eli Lilly and Abbvie: Product management
M.D. degree from Faculté Necker-Enfants Malades
(Paris)
Graduate and post-graduate degrees in
pharmacology and immunology from École Normale
Supérieure (Paris)
4
Develop the medicines of tomorrow to improve the lives of patients
suffering from serious diseases
© MorphoSys AG | Meet the Team | June 25, 2019
Our Mission
5© MorphoSys AG | Meet the Team | June 25, 2019
We are at an inflection point on the way to becoming
a fully integrated biopharmaceutical company
6
Leveraging our clinical assets to anchor a new growth trajectory
© MorphoSys AG | Meet the Team | June 25, 2019
Strong Clinical Pipeline
Segment revenues
2018
Partnered Discovery
23 clinical candidates
25 programs in preclinic
58 programs in discovery
Valu
e
Business transformation
~€54 million
~€23 million
Segment revenues
2018
Proprietary Development
5 clinical candidates
1 program in preclinic
6 programs in discovery
Tremfya®
MOR106
MOR103
MOR202
tafasitamab
7
An ENFORCER™ antibody
© MorphoSys AG | Meet the Team | June 25, 2019
Tafasitamab
tafasitamab
ENFORCER™
Enhanced Format for Cancer Eradication
Fc-engineered to address:
Increased recruitment of effector cells
Enhanced elimination of cancer cells
8
NHL – Non-Hodgkin lymphoma CLL – Chronic lymphotic leukemia ALL – Acute lymphoblastic leukemia
Assessing the clinical potential of our key proprietary asset
© MorphoSys AG | Meet the Team | June 25, 2019
Tafasitamab Value Proposition
Chemo-free regimen aiming to improve
quality of life and outcome for patients
43% complete response rate
21.7 months duration of response
Data support overall survival outcome
ENFORCER™ goal to drive effective immune-mediated killing of malignant B cells
Demonstrated activity with lenalidomide
Single agent activity shown in other
forms of NHL, CLL & B-ALL
Readily combined with other agents
Opportunity to develop broadly
DLBCL Other B cell malignancies
9
Addressing different treatment approaches with L-MIND and B-MIND
© MorphoSys AG | Meet the Team | June 25, 2019
Tafasitamab Clinical Trials in DLBCL
Tafasitamab + bendamustine
vs.
rituximab + bendamustine
Tafasitamab + lenalidomide
vs.
virtual lenalidomide-only
L-MIND B-MIND
Phase 2, open-label, single-arm trial
Virtual lenalidomide-only comparator arm
Compelling primary analysis data
Study ongoing with responding patients
Chemo-free regimen
Phase 2/3, randomized, multicenter trial
Biomarker subgroup: ~50% of patients
Futility analysis H2 2019
1. All-comers pass futility
Final data Q1 2020 (330 patients)
2. Only subgroup passes futility
Final data Q1 2021 (450 patients)
3. All-comers and subgroup fail futility
Study is futile
Different
combinations
Combination with an
immuno-modulatorCombination with a
chemotherapeutic
Different
modes of action
10
U.S. Commercial Strategy
Create U.S. hub to accelerate market uptake
Regulatory Strategy Framework
Pursue regulatory approval for tafasitamab in U.S. and EU
Setting a trajectory for greater value creation
© MorphoSys AG | Meet the Team | June 25, 2019
Corporate Strategy
Clinical Development Direction
Seize tafasitamab opportunities to drive sustainable growth
Partnering
Maximize the value of our key asset
11
MorphoSys US Inc. located at Boston Harbor
© MorphoSys AG | Meet the Team | June 25, 2019
MorphoSys U.S. Subsidiary
Located in the heart of the U.S. No. 1 Life
Sciences Cluster
Highly attractive to best-in-class talent
Strategic position for direct U.S. market access
12
L-MIND:
Breakthrough Therapy Designation granted in 2017
Close alignment with the FDA - minimizing risks
FDA guidance on reasonable ways forward
Planned BLA submission by end of 2019
Earliest approval mid-2020
B-MIND:
Pre-planned interim analysis in H2 2019
BLA – Biologics license agreement
Pursue regulatory approval for tafasitamab in U.S. and EU
© MorphoSys AG | Meet the Team | June 25, 2019
Regulatory Strategy
FDA progress and next steps
EMA progress and next steps
L-MIND:
First interactions with national health authorities
Submitted request for scientific advice to EMA
13
Maximizing the value of tafasitamab with the best possible deal
© MorphoSys AG | Meet the Team | June 25, 2019
Partnering Tafasitamab
Tafasitamab
Our flagship
asset
Strong interest based
on compelling clinical
data
Good chance for favorable regulatory
path in Europe – significant impact on
value of program
Focusing on exclusive
MorphoSys U.S. rights
In discussions with
interested parties
14
Key strategic directions for next wave of clinical trials
© MorphoSys AG | Meet the Team | June 25, 2019
Clinical Development Direction
Position tafasitamab in competitive environment
Seize front-line DLBCL opportunities for tafasitamab
Go broad and deepin r/r DLBCL
Initiate development in other, non-DLBCL indications
15© MorphoSys AG | Meet the Team | June 25, 2019
Summary
Well on track with our goal to transform into
a fully integrated biopharmaceutical company
MorphoSys is set to become a key player
in the oncology field in the U.S.
Driving clinical assets development to enhance
proprietary pipeline product value
SUMMARY