Results Q1 2019 - MorphoSys · 2019-10-30 · Current clinical development I-Mab: Chinese region...
Transcript of Results Q1 2019 - MorphoSys · 2019-10-30 · Current clinical development I-Mab: Chinese region...
Results Q3 2019 MorphoSys AG
October 30, 2019
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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, interpretations by regulatory authorities of our clinical data and real-world
data analyses, in particular with respect to tafasitamab (MOR208), and the transition of MorphoSys to a fully integrated biopharmaceutical company, the
expected time of launch of tafasitamab (MOR208), 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 (MOR208), 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 (MOR208) 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®). There is no guarantee any investigational product will be approved.
This presentation includes forward-looking statements.
© MorphoSys, Q3 2019 - October 30, 2019
3© MorphoSys, Q3 2019 - October 30, 2019
Agenda
Dr. Jean-Paul Kress
Chief Executive Officer
Jens Holstein
Chief Financial Officer
Dr. Malte Peters
Chief Development Officer
Dr. Sarah Fakih
Head of Corp Com & IR
Operational Review1.Dr. Jean-Paul Kress
Financials and Guidance2.Jens Holstein
Q&A Session3.Dr. Jean-Paul Kress
Jens Holstein
Dr. Malte Peters
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1) Revenues are expected to include royalty income from Tremfya® guided for €30-35m at constant USD exchange rate 2) Incl. Technology Development; BLA: Biologic
License Application; FDA: Food and Drug Administration
© MorphoSys, Q3 2019 - October 30, 2019
Q3 Key Take-aways
In € millionReported Q1-Q3 2019 Guidance 2019
(As of July 3, 2019)
60.7 65 to 721)
68.8 95 to 105
-56.3 -105 to -115
412.4
Group Revenues
Proprietary R&D Expenses2)
EBIT
Cash Position
Financial Results
Q3 2019 Highlights: Executing on our top priorities
Flawless submission of BLA for tafasitamab (MOR208)
Re-MIND: successful real-world data approach confirms regulatory strategy
Rolling submission for BLA initiated: preclinical data package submitted to FDA
Partnering tafasitamab
Primary goal to maximize the value of tafasitamab
Discussions with interested parties ongoing
Unlock the value of our proprietary pipeline
MOR202: start of clinical trial in autoimmune disease is imminent
Gantenerumab: positive aducanumab encouraging news for patients
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Operational Review Q3 2019
and Outlook 2019
© MorphoSys, Q3 2019 - October 30, 2019
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r/r: relapsed/refractory; DLBCL: diffuse large B cell lymphoma; LEN: lenalidomide
Investigational antibody developed in hematological malignancies
Re-MIND Topline Data
Outcome data of non-transplant eligible r/r DLBCL patients treated with LEN monotherapy in real-world setting
Qualification criteria met for 76 Re-MIND patients, 1:1 matching to 76 of 80 L-MIND patients
Data will be part of BLA submission which is on track to be completed by end of the year
Probability to survive twice as high in the tafasitamab-LEN combination versus the LEN-monotherapy
© MorphoSys, Q3 2019 - October 30, 2019
Tafasitamab: Proprietary Antibody Against CD19
lenalidomide
monotherapy
tafasitamab/lenalidomide
combination
67.1%objective
response rate34.2%
complete
response rate11.8% 39.5%
All data
investigator-assessed
Data based on 76
patients of each
cohort
median overall
survival9.3 mo NR
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DLBCL: diffuse large B cell lymphoma; LEN: lenalidomide; BEN: bendamustine; CLL: chronic lymphocytic leukemia; SLL: small lymphocytic lymphoma FDA: Food and Drug
Administration; EMA: European Medicines Agency
Investigational antibody developed in hematological malignancies
Current clinical development
L-MIND (phase 2), r/r DLBCL Tafasitamab + LEN
B-MIND (phase 3), r/r DLBCL Tafasitamab + BEN vs. rituximab + BEN
COSMOS (phase 2), r/r CLL/SLL Tafasitamab + idelalisib or venetoclax
2019/2020 catalysts
U.S.:
Rolling submission to FDA initiated: preclinical data package submitted
BLA submission to be completed by end-2019
Europe: Complete MAA submission to EMA by mid-2020
Clinical development
B-MIND: Pre-planned, event-driven interim analysis expected in Q4 2019
Frontline study DLBCL: Ph1b trial in Q4 2019, followed by pivotal ph2/3
COSMOS: Data planned to be presented at ASH in early December
© MorphoSys, Q3 2019 - October 30, 2019
Tafasitamab: Proprietary Antibody Against CD19
Fc-engineered antibody intended
to result in:
Increased recruitment of
effector cells
Enhanced elimination of
cancer cells
Development in hematological
malignancies
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LEN: lenalidomide; IND: investigational new drug; NMPA: National Medical Product Administration; PLA2R: Phospholipase-A2 receptor
Opportunity in autoimmune diseases & oncology
The product candidate
Antibody against CD38
Development in multiple myeloma and autoimmune diseases
Current clinical development
I-Mab: Chinese region
Pivotal phase 3 study: MOR202 + LEN in r/r 2L multiple myeloma
Pivotal phase 2 study: MOR202 in r/r 3L multiple myeloma
Q3 news flow
MorphoSys: First sites initiated for clinical trial in a chronic inflammatory
autoimmune disease (anti-PLA2R antibody positive membranous nephropathy)
I-Mab: IND clearances for MOR202 by Chinese NMPA to expand ongoing trials
to mainland China
© MorphoSys, Q3 2019 - October 30, 2019
MOR202: Proprietary Antibody Against CD38
Financials and deal terms
I-Mab: Exclusive development
and commercialization rights in
China, Taiwan, Hong Kong and
Macao
Up-front: $20m
Milestones: Up to $100m
Royalties: Tiered, double digit
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* All payments shared with Galapagos 50/50; IL: interleukin; DMC: Data Monitoring Comittee
Targeting inflammatory skin diseases
The product candidate
Antibody against IL-17C
Development in atopic dermatitis
Clinical development in atopic dermatitis: Stopped for futility
Phase 2 study GECKO Subcutaneous, combination with topical steroids
Phase 2 study IGUANA Intravenous, testing for safety and efficacy
Phase 1 study Bridging study for subcutaneous formulation
Phase 1/2 study Japanese ethno-bridging study (Angelfish)
Q3 news flow
Interim analysis for futility of phase 2 IGUANA study:
Low probability to meet the primary endpoint of the study
Observed lack of efficacy, no safety concerns
Joint decision of all three involved parties to stop clinical development in
atopic dermatitis
2019/2020 catalysts
Parties will explore the future strategy with MOR106
© MorphoSys, Q3 2019 - October 30, 2019
MOR106: Proprietary Antibody Against IL-17C
Financials and deal terms*
Co-developed with Galapagos
Worldwide, exclusive
partnership with Novartis
Up-front: €95m
Milestones: up to €850m
Royalties: tiered, low teens
to low twenties
Novartis carries all R&D,
manufacturing & commercial
costs
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The drug
Antibody against IL-23
Generated using MorphoSys’s HuCAL technology
2019/2020 catalysts
Tiered royalty stream
Janssen announced submission of supplemental BLA for Tremfya® to
U.S. FDA and MAA to EMA for treatment of psoriatic arthritis
Broad clinical development
© MorphoSys, Q3 2019 - October 30, 2019
Tremfya® (Guselkumab)
1) U.S., EU, Canada, Brazil, Australia, Japan; 2) Japan; IL: Interleukin; BLA: biologics license application; FDA: Food and Drug Administration; MAA: Marketing
Authorization Application; EMA: European Medicines Agency
Phase 1 Phase 2 Phase 3 Approved/ Launched
Familial adenomatous
polyposis
Crohn’s disease
Hidradenitis suppurativa
Ulcerative colitis
Plaque psoriasis
Pustular/erythrodermic
psoriasis
Psoriatic arthritis
Psoriasis1)
Psoriatic arthritis2)
Palmoplantar pustulosis2)
50
100
150
200
250
300
Tremfya® sales reported by Janssen
Q1 Q1Q2 Q3 Q4
2018 2019
US-$
Q2 Q3
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Financials Q3 & Q1-Q3 2019
Guidance 2019
© MorphoSys, Q3 2019 - October 30, 2019
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Rounding differences may occur
© MorphoSys, Q3 2019 - October 30, 2019
Consolidated Statement of Profit or Loss (IFRS)
In € million Q3 2019 Q3 2018 Change
Revenues 12.5 55.0 (77%)
Operating Expenses
Cost of Sales (1.0) (0.9) (11%)
Research and Development (25.9) (18.0) (44%)
Selling (4.4) (1.3) >(100%)
General and Administrative (9.0) (5.1) (76%)
Total Operating Expenses (40.3) (25.3) (59%)
Other Income / Expenses 0.8 0.4 >100%
Earnings before Interest and Taxes (EBIT) (27.0) 30.1 >(100%)
Finance Income 2.4 0.1 >100%
Finance Expenses (0.2) (0.1) (100%)
Income from Reversals of Impairment Losses /
(Impairment Losses) on Financial Assets 0.0 0.3 >(100%)
Income Tax Benefit / (Expenses) 0.6 (0.2) >100%
Consolidated Net (Loss) / Profit (24.2) 30.2 >(100%)
Earnings per share, basic and diluted (in €) (0.76) 0.96 >(100%)
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48,8
-18,6
30,3
1,4
-32,0 -30,4
Rounding differences may occur
© MorphoSys, Q3 2019 - October 30, 2019
Segment Reporting Q3 2019 and Q3 2018
Proprietary Development Partnered DiscoveryIn € million
6,2
-2,4
3,811,0
-2,3
8,8
In € million
Revenues OpEx EBITRevenues OpEx EBIT
2018
2019
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Rounding differences may occur
© MorphoSys, Q3 2019 - October 30, 2019
Consolidated Balance Sheet (IFRS)
In € million Sept 30, 2019 Dec 31, 2018
Assets
Current Assets
Cash and Cash Equivalents 58.5 45.5
Financial Assets at Fair Value trough Profit or Loss 58.0 44.6
Other Financial Assets at Amortized Cost 270.9 268.9
Other Current Assets 32.3 29.9
Total Current Assets 419.8 388.9
Non-current Assets
Other Financial Assets at Amortized Cost, Net of current portion 25.0 95.7
Other Non-current Assets 96.4 54.1
Total Non-current Assets 121.4 149.9
Total Assets 541.1 538.8
Liabilities & Stockholders’ Equity
Total Current Liabilities 53.8 45.9
Total Non-current Liabilities 44.2 4.5
Total Stockholders’ Equity 443.1 488.4
Total Liabilities & Stockholders’ Equity 541.1 538.8
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Rounding differences may occur
© MorphoSys, Q3 2019 - October 30, 2019
Key Financials (Q1-Q3 2018/2019)
In € million Q1-Q3 2019 Q1-Q3 2018 Change
Revenues 60.7 66.0 (8%)
Operating Expenses
Cost of Sales (10.9) (0.9) >(100%)
Research and Development (75.3) (61.0) (23%)
Selling (9.3) (3.6) >(100%)
General and Administrative (22.4) (14.5) (54%)
Total Operating Expenses (117.8) (80.0) (47%)
Earnings before Interest and Taxes (EBIT) (56.3) (13.0) >(100%)
Consolidated Net (Loss) / Profit (52.7) (12.8) >(100%)
Earnings per share, basic and diluted (in €) (1.67) (0.41) >(100%)
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1) Guidance update in connection with milestone payment of €22m from GSK after start of phase 3 clinical development program with otilimab (MOR103/GSK3196165) in
rheumatoid arthritis.
2) Revenues are expected to include royalty income from Tremfya® ranging from €30-35m on constant $ currency.
© MorphoSys, Q3 2019 - October 30, 2019
Financial Guidance 2019
In € million
Reported FY 2018 Reported Q1-Q3 2019 Guidance 20191)
(As of July 3, 2019)
76.4 60.7 65 to 722)
98.3 68.8 95 to 105
-59.1 -56.3 -105 to -115
Group Revenues
Proprietary R&D Expenses
(incl. Technology Development)
EBIT
Total ordinary shares issued as of September 30, 2019: 31,927,958
Germany, Frankfurt Stock Exchange: MOR
U.S., NASDAQ Global Market: MOR
Cash Position September 30, 2019: €412.4 m
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Q&A
© MorphoSys, Q3 2019 - October 30, 2019
Tafasitamab (MOR208), MOR202, MOR106, otilimab (MOR103), anetumab ravtansine, gantenerumab and all other product candidates mentioned here are investigational
drugs and have not been approved by the FDA or other ex-US regulatory agencies. HuCAL® , HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®,
Ylanthia®, 100 billion high potentials®, Slonomics®, Lanthio Pharma®, LanthioPep® and ENFORCERTM are trademarks of the MorphoSys Group. Tremfya® is a trademark
of Janssen Biotech, Inc.
www.morphosys.com
Thank You
Corporate Communications & IR
Phone +49 (0)89 / 899 27-404
Fax +49 (0)89 / 899 27-5404
Email [email protected]