bofaml 2015 health care conference - morphosys · guselkumab data from 3 pivotal trials in...

Company UpdateMay 12, 2015

© MorphoSys - May 2015

BofAML 2015 Health Care Conference

1

Safe Harbor


This presentation includes forward-looking statements.

Actual results could differ materially from those included in the forward-looking statements due to

various risk factors and uncertainties including changes in business, economic competitive

conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing.

These and other risks and uncertainties are detailed in the Company’s Annual Report.

2

The MorphoSys Pipeline

23 Clinical Programs, 99 Total

© MorphoSys - May 2015 3

Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3

Bimagrumab (BYM338) Novartis ActRIIB sIBM (musculoskeletal)

Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

MOR103 GSK GM-CSF Inflammation

MOR208 - CD19 ALL, CLL, NHL

BHQ880 Novartis DKK-1 Multiple myeloma

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

LFG316 Novartis C5 Eye diseases

LJM716 Novartis HER3 Cancer

NOV–3 Novartis - not discl.

Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors

VAY736 Novartis BAFF-R Inflammation

MOR202 - CD38 Multiple myeloma

MOR209/ES414 Emergent PSMA/CD3 Prostate cancer

Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors

BI–836845 BI IGF-1 Solid tumors

NOV–7 Novartis - Eye diseases

NOV–8 Novartis - Inflammation

NOV-9 Novartis - Diabetic eye diseases

NOV-10 Novartis - Cancer

PF-05082566 Pfizer 4-1BB Solid tumors

Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors

MOR106 Galapagos - Inflammation

MOR107 (LP2) - AT2-R Fibrosis

27 programs Various - Various

Immuno-oncology program Merck Serono - Cancer

7 MOR programs - - Various

39 programs Various - Various

85 Partnered Programs

14 MOR Programs

Most advanced development stage

Acquisition of Lanthio Pharma


History

2012

MOR takes minority stake in Lanthio Pharma

Collaboration to develop lanthipeptide libraries for drug

discovery

2015: Acquisition of Lanthio Pharma

Most Advanced Program

LP2 (re-named MOR107)

Pre-IND candidate for fibrotic diseases

Potent angiotensin II type 2 (AT2) receptor-dependent

activity in vivo

Start of Phase 1 expected 2016

Technology & Portfolio

Library of constrained peptides (lanthipeptides)

Emerging compound class which offers the potential to

address many types of target and disease categories

Three discovery-stage programs

Lanthio Pharma

Groningen, Holland

Founded: 2010

10 employees

MOR Proprietary Programs


Program Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

Unpartnered

MOR208 CD19 NHL

CLL

ALL

MOR202 CD38 Multiple myeloma

Co-development & co-promotion with Emergent BioSolutions

MOR209/ES414 PSMA/CD3 Prostate cancer

Licensed to GSK (tiered, double-digit royalties)

MOR103 GM-CSF Inflammation

Early-stage programs

MOR106 Inflammation

MOR107 (LP2) AT2 Receptor Fibrosis

8 Programs Various

5

FTD, orphan status US & EU

Orphan status US & EU

Program Partner Target Indication Phase 1 Phase 2 Phase 3

Bimagrumab Novartis ActRIIB sIBM (52 weeks)

(BYM338) sIBM (long-term study)

Cachexia (COPD)

Cachexia (cancer)

Hip fracture surgery

Sarcopenia

BHQ880 Novartis DKK-1 MM (renal insufficiency)

Smoldering MM

LFG316 Novartis C5 Wet AMD

Geographic atrophy

MCP

NOV-3 Novartis n.d. n.d.

VAY736 Novartis BAFF-R Pemphigus vulgaris

Primary Sjögren's syndrome

RRMS

LJM716 Novartis HER3 ESCC (combo with BYL719)

HER2+ cancer (combo with

BYL719 & trastuzumab)

HER2+ cancer, combination with

trastuzumab

HER2+ cancer

Advanced solid tumors

NOV-7 Novartis n.d. Eye disease

NOV-8 Novartis n.d. Inflammation

NOV-9 Novartis n.d. Diabetic eye disease

NOV-10 Novartis n.d. Cancer

Partnered Clinical Pipeline (I)


Program Partner Target Indication Phase 1 Phase 2 Phase 3

Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1)

(CNTO1959) Psoriasis (VOYAGE 2)

Psoriasis (NAVIGATE)

Pustular/Erythrodermic Psoriasis

Moderate to severe psoriasis

Palmoplantar pustulosis

Active psoriatic arthritis

Gantenerumab Roche Amyloid-ß Mild Alzheimer‘s disease

Genetically predisposed

CNTO3157 Janssen/J&J n.d. Asthma

Safety/Pharmacokinetic

CNTO6785 Janssen/J&J n.d. COPD

Rheumatoid arthritis

Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE)

(OMP-59R5) Small cell lung cancer (Pinnacle)

Solid tumors

Vantictumab Oncomed/Bayer Fzd 7 Solid tumors

(OMP-18R5) Breast cancer

Pancreatic cancer

NSCLC

Anetumab Ravtansine Bayer Mesothelin Solid tumors

(BAY94-9343)

BI-836845 BI IGF-1 Solid tumors, Japanese patients

EGFR mutant NSCLC

Breast cancer

CRPC + enzalutamide

Various solid cancer


PF-05082566 Pfizer 4-1BB Solid Tumors, NHL (+rituximab)

Solid tumors, combination with

PD-1 inhibitor MK-3475

Partnered Clinical Pipeline (II)


Financial Guidance 2015


in EUR millions 2014A Q1 2015 Guidance 2015

Group Revenues 64.0 70.4 101 - 106

Proprietary R&D Expenses

(incl. Technology Development)36.4 10.4 56 – 63

EBIT -5.9 52.8 9 - 16

Cash, cash equivalents & marketable securities

as well as other short- & long-term financial assets352.8 349.7

8

What to Expect in 2015 & 2016


MOR202Data from phase 1/2a trial at ASCO 2015

Start phase 1/2a LEN & POM combo cohorts

Pipeline Up to 10 new INDs

Potential in-licensing of additional compounds

Guselkumab Data from 3 pivotal trials in psoriasis expected 2016

Bimagrumab Data from pivotal trial in sporadic inclusion body myositis expected early 2016

MOR209 First phase 1 data expected in 2016

MOR208Updated data from phase 2 mono-therapy trial at ASCO 2015

NHL: Start phase 2 LEN & BEN combo trials in DLBCL

CLL: Start phase 2 combo trials

ALL: Start phase 2 pediatric IST - MOR208 plus NK cell transfusion

PH

ASE

2PH

ASE 3

PH

ASE 1

Clinical Trials Scheduled for Completion


20162015

Potential data events based on clinical trial design & MorphoSys estimates Partnered Programs

MOR Programs

10

LJM716

ESCC, combo w/BYL719

VAY736

RRMS

MOR208

NHL (mono - update)

Guselkumab

Psoriasis (VOYAGE 2)

Guselkumab

Psoriasis (VOYAGE 1)

Bimagrumab

sIBM

Guselkumab

Psoriasis (NAVIGATE)

Bimagrumab

Hip fracture surgery

MOR202

Multiple myeloma

MOR208

ALL (mono)

MOR208 - IST

CLL (combo with len)

Bimagrumab

Sarcopenia

LJM716

HER2+ cancer (combo)

LJM716

HER2+ cancer (combo)

LJM716


CNTO6785

Rheumatoid arthritis

CNTO6785

COPD

Tarextumab

Pancreatic cancer

Tarextumab

Solid tumors

Vantictumab

Solid tumors

Vantictumab

Pancreatic cancer

Vantictumab

NSCLC

Vantictumab

Breast cancer

BAY94-9343

Solid tumors

BI-836845

Solid tumors (Japan)

BI-836845

NSCLC

BI-836845

Various solid tumors

BI-836845


LFG316

MCP

LFG316

Geographic atrophy

MOR209

Prostate cancer

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla® , Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.

Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.

Dr. Claudia Gutjahr-Löser

Head of Corporate Communications & IR

Phone +49 (0)89 / 899 27-122

Fax +49 (0)89 / 899 27-5122

Email [email protected]

Thank You

www.morphosys.com

MOR208

A Novel Antibody to Treat B cell Malignancies


DRUG Fc-enhanced, humanized antibody targeting CD19

Fc modification leads to dramatically enhanced B cell depletion

Convenient dosing schedule, straightforward manufacturing

Fast Track Designation in DLBCL; FDA & EMA Orphan Drug Status in DLBDL and CLL/SLL

CLINICAL Phase 2 clinical development in NHL, CLL and ALL

NHL

Focus on 4 sub-types DLBCL, FL, MCL and other iNHL

Encouraging single agent activity

CLL

Encouraging single agent activity

ALL

Signs of activity, but ORR not sufficient to justify continuation with mono-therapy:

Phase 2 mono-therapy trial in ALL discontinued

NEXT NHL

Updated phase 2 mono-therapy data at ASCO

DLBCL: Initiate two combo trials, + lenalidomide & + bendamustine, H2 2015

CLL: Initiate combo trials, Q4 2015/Q1 2016

ALL: Initiate pediatric phase 2 IST, + NK cell transfer from parental donor (with St.

Jude Children's Research Hospital, USA), H2 2015

* Patients who have completed two cycles of treatment and subsequently received disease response assessment

MOR208 Demonstrates Efficacy in DLBCL, FL

and iNHL


Efficacy outcome, n (%) DLBCL

(n=35)

FL

(n=31)

iNHL

(n=11)

MCL

(n=12)

Overall

(n=89)

Complete Response 2 (6%) 1 (3%) 1 (9%) 0 4 (4%)

Partial Response 7 (20%) 6 (19%) 3 (27%) 0 16 (18%)

Stable Disease 5 (14%) 14 (45%) 3 (27%) 6 (50%) 28 (31%)

Progressive Disease 11 (31%) 4 (13%) 3 (27%) 5 (42%) 23 (26%)

Not evaluable 10 (29%) 6 (19%) 1 (9%) 1 (8%) 18 (20%)

ORR (all pts in cohort) 9 (26%) 7 (23%) 4 (36%) 0 20 (22%)

ORR (evaluable patients*) 9 (36%) 7 (28%) 4 (40%) 0 20 (28%)

Blum et al. #3089, ASH 2014

International, multi-center, open-label phase 2 study

12 mg/kg MOR208 weekly

Two-stage design (total of 120 patients)

Stage 1: 10 patients per subgroup

Stage 2: 20 patients per subgroup (with at least 2 PR in stage 1)

Cycle 1 Cycle 2 Cycle 3Maintenance

(bi-weekly or monthly)> PR> SD

MOR208 is Superior to Other CD19 & CD20

MAbs in Relapsed/Refractory CLL


α-CD19 MAbs α-CD20 MAbs

38%24% 30%

23%13%

MOR20812mg/kg(n=16)

MEDI-551phase 1/212mg/kg(n=26)

Obinutuzumabphase 2(n=20)

Ofatumumabphase 3(n=196)

Rituximab(n=110)

Response Rates Based on IWCLL2008 Criteria

ORR

SD, PD &

Non-evaluable

MEDI-551 data source: Poster

ASCO 2013, 12mg/kg dosing group

Obinutuzumab data source:

GAUGUIN study, Cartron et al,

Blood 2014

Ofatumumab data source: control

arm in ibrutinib vs. O phase 3

trial (RESONATE, ASCO 2014)

Rituximab data source: Late

breaking abstract #6, ASH 2013

Criteria: Hallek et al 2008

(including CT)

mPFS

(mo.)15 nr 10.7 8 5.5

MOR202

A Novel Antibody for Multiple Myeloma


DRUG High affinity HuCAL antibody targeting CD38

Binds to a unique epitope

Ability to kill MM cells in vitro and across

multiple in vivo models (ADCC & ADCP)

2 hour infusion time

MorphoSys regained all rights from Celgene

DATA Strong synergy with IMiDs (lenalidomide and

pomalidomide) and proteasome inhibitors

(bortezomib) in pre-clinical models

NEXT First clinical data to be presented at ASCO

2015 (mono-therapy)

Additional cohorts with weekly dosing

schedule, with and without dexamethasone

ongoing

Combination cohorts with pomalidomide and

lenalidomide to start in H1 2015; Celgene will

supply both IMiDs on preferred terms

MOR202 Shows High ADCC and ADCP

Activity as Single Agent

MOR209/ES414 - A Bi-specific

Immunotherapeutic Against Prostate Cancer


DRUG Bi-specific anti-PSMA/anti-CD3 immunotherapeutic:

targeting PSMA on prostate cancer cells

targeting CD3 on cytotoxic T cells

Redirects T cells to kill tumor cells expressing PSMA

in vitro and in vivo

DATA Reduced cytokine release upon T cell activation

compared to other formats

Prolonged serum half-life in mouse and NHP

compared to antibody fragments

Well-tolerated in NHP single-dose and repeat-dose

studies

NEXT Phase 1 in mCRPC in the U.S. and Australia initiated

Stage 1: identify MTD of MOR209/ES414

administered iv

Stage 2: evaluate clinical activity in patients that

have or have not received prior chemotherapy

Bimagrumab (BYM338)

A Novartis Musculoskeletal Program


DRUG HuCAL antibody against ActRIIB

FDA breakthrough therapy designation for

sporadic inclusion body myositis (sIBM)

Orphan drug designation in sIBM

CLINICAL

DATA

Potential novel treatment of sIBM

Phase 2 results in sIBM[1]:

Muscle mass increased substantially from

baseline, approx. 5% more than placebo

Muscle gain was functional as supported by

parallel increases in strength and 6-minute

walking distance

NEXT Pivotal study in sIBM with 240 patients

ongoing, completion scheduled in Q4 2015

Listed by Novartis as “planned filing 2016”

Phase 2 read-outs in hip fracture surgery,

sarcopenia expected in 2016

17

sIBM patient who has typical prominent

weakness and atrophy of quadriceps and

finger flexors[2]

[1] A Amato et al; Neurology; Nov 7, 2014, online

[2] WK Engel and V Askanas; Neurology 2006; 20-29

Guselkumab (CNTO1959)

A Janssen Anti-Inflammatory Program


Results from phase 2b study: 293 patients with mild-to-moderate plaque psoriasis

@week 16 Placebo 5 mg 50 mg 200 mg 15 mg 100 mg Humira

at week 0, 4, then every 12 weeks every 8 weeks

PGA 0 or 1 7% 34% 79% 83% 61% 86% 58%

PASI 75 5% 44% 81% 81% 76% 79% 70%

PASI 90 2% 34% 45% 57% 34% 62% 44%

DRUG HuCAL antibody specific for IL-23, doesn’t bind IL-12

Specificity may provide better risk/benefit profile

Dosing schedule sc q8w or even less frequently

Being developed in psoriasis and psoriatic arthritis

CLINICAL

DATA

Phase 2b results in psoriasis at week 16

Up to 86% of patients achieved a Physician's

Global Assessment (PGA) score of cleared or minimal

disease at week 16 (primary endpoint)

Significantly higher levels of efficacy at all doses

compared to placebo group

NEXT Three Phase 3 trials scheduled for completion in 2016

“Planned filings 2013–2017” (J&J analyst day 2013)

Clinical response to a single dose of

10 mg of guselkumab administered

at baseline[1]

[1] H Sofen et al; J Allergy Clin Immunol 2014;

133: 1032-40

Gantenerumab

A Roche Alzheimer’s Disease Program


Data: Courtesy of Roche

19

DRUG HuCAL antibody against amyloid-ß, binds N-

terminus and middle of peptide

Binds/disrupts amyloid plaque and oligomers;

binds peptide only weakly

CLINICAL

DATA

In phase 1, gantenerumab clears brain amyloid

very efficiently in mild-to-moderate AD patients

Phase 3 SCarlet RoAD trial in prodromal patients

discontinued based on pre-planned futility

analysis

Phase 3 Marguerite RoAD trial with 1,000

patients with mild AD ongoing

DIAN network trial in genetically pre-disposed

patients ongoing

NEXT Data from the SCarlet RoAD study will be shared

by Roche with the medical community after full

review and analysis

Data from Phase 1

Effect of gantenerumab on amyloid load

as indexed by PET SUVR at end of

treatment

% A

mylo

id c

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from

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bofaml 2015 health care conference - morphosys · guselkumab data from 3 pivotal trials in...

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