EX-99.2 3 d56509dex992.htm EX-99.2 EX-99.2

Slide 1

Q1 Results May 6, 2021 Exhibit 99.2


Slide 2

© MorphoSys - Q1 2021 results This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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' 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 MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of Monjuvi, MorphoSys' 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' Annual Report on Form 20-F and other filings with the U.S. 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 Medicines Agency (EMA) or any other regulatory authority (except for tafasitamab/Monjuvi® and guselkumab/Tremfya®). There is no guarantee any investigational product will be approved.   Forward-Looking Statements


Slide 3

Agenda © MorphoSys - Q1 2021 results Q1 2021 Results Conference Call Highlights Q1 2021 and 2021 Outlook Jean-Paul Kress, M.D., CEO Financial Results Q1 2021 Sung Lee, CFO Q&A Jean-Paul Kress, Sung Lee, Roland Wandeler, Malte Peters Commercial Update Roland Wandeler, Ph.D., COO


Slide 4

Highlights Q1 2021 Outlook 2021 Jean-Paul Kress, M.D., CEO © MorphoSys - Q1 2021 results


Slide 5

Key Priorities for 2021 © MorphoSys - Q1 2021 results 2021 Focus Continued execution of the Monjuvi launch in the U.S. Monjuvi Launch Progress the development of felzartamab in autoimmune diseases Expanding the Pipeline Expand tafasitamab opportunity by initiating pivotal studies in 1st line DLBCL, r/r indolent lymphomas (FL/MZL) as well as combination studies European Marketing Authorization Application is currently under review Tafasitamab Development and Backbone Strategy


Slide 6

Multiple opportunities to address significant unmet needs in non-Hodgkin lymphomas © MorphoSys - Q1 2021 results Broad Tafasitamab Clinical Program to Maximize Value for Patients Study Indication Status Ph 1 Ph 2 Ph 3 Market L-MIND r/r DLBCL FDA approved in 2L B-MIND r/r DLBCL Ongoing firstMIND 1L DLBCL Ongoing 1L DLBCL Trial initiation expected H1 2021 r/r FL / MZL Ongoing r/r B-cell malignancies Parsaclisib1) combination trial initiation expected 2021 CD20xCD3 combination r/r DLBCL 1L DLBCL r/r FL First trial expected to start e/o 2021 / early 2022 Studies sponsored by Xencor J-MIND (Japan) r/r DLBCL and others Ongoing 1) Parsaclisib: PI3Kd inhibitor owned by Incyte; The clinical development program does not guarantee a regulatory approval; r/r: relapsed or refractory; DLBCL: diffuse large B-cell lymphoma; FL: follicular lymphoma; MZL: marginal zone lymphoma


Slide 7

1. Trujillo H et al. Port J Nephrol Hypert 2019; 33 (1): 19-27. 2. Passerini P et al. Front Immunol 2019; 10: 1326. 3. Physician interviews; ClearView analysis CD38 Antibody in Clinical Development © MorphoSys - Q1 2021 results Exploring Felzartamab in Autoimmune Diseases IgA Nephropathy (IGAN) Second autoimmune indication for felzartamab Most common glomerular disease worldwide High unmet need, ~20% of patients progress to end-stage renal disease (ESRD) within 10 years3) IGNAZ trial to be initiated mid-2021 Autoimmune Membranous Nephropathy (aMN) 10,000 addressable patients in the U.S. High unmet need, 30%–50% of patients progress to end-stage renal disease (ESRD) within 10–15 years1)2) M-PLACE and New-PLACE studies ongoing Clinical Development Different B-cell stages produce autoantibodies which damage organ tissue in autoimmune diseases


Slide 8

Commercial Update Roland Wandeler, Ph.D., COO © MorphoSys - Q1 2021 results


Slide 9

© MorphoSys - Q1 2021 results Monjuvi Launch Update Monjuvi Sales $15.5M Net Sales Q1 2021 * partial quarter Q1 Headwinds COVID-19 and transitory winter storm Q4 2020 benefitted from inventory dynamics and clinical trial purchases Underlying Trends Ongoing COVID-19 impact in H1 Patient demand slightly higher sequentially Continued positive HCP feedback Increase in account growth (>500 accounts as of the end of Q1 2021) $17.0M $5.0M $15.5M


Slide 10

Source: Integrichain 867 report April, 30, 2021. SOC represents Project LASeR algined SOC accounts. Utilization represents Community vs. Academic settings. © MorphoSys - Q1 2021 results Foundation for Long-Term Growth Q3’20 Q4’20 Q1’21 Building Account Momentum Focus on Driving Uptake in 2L DLBCL Cumulative sites of care >500 end of March Increasing utilization in community setting Driving a Paradigm Shift in DLBCL Monjuvi’s safety, tolerability and long duration of response Treat patients to progression Positive HCP feedback and leveraging LT data L-MIND 2-year data presented in 2020 at EHA and ASH Upcoming 3-year L-MIND data to be presented at ASCO, EHA, ICML conferences Q3’20 Q1’21 Community setting Academic setting


Slide 11

Financial Results Q1 2021 Sung Lee, CFO © MorphoSys - Q1 2021 results


Slide 12

* Differences due to rounding © MorphoSys - Q1 2021 results Q1 2021: Profit or Loss Statement* In € million Q1 2021 Q1 2020 Revenues 47.2 251.2 (81%) Monjuvi 12.9 - - Royalties 11.6 9.3 25% Licenses, Milestones and Other 22.7 241.9 >(100%) Cost of Sales (5.0) (3.3) 52% Gross Profit 42.1 248.0 (83%) Total Operating Expenses (71.7) (44.4) 61% R&D Expenses (33.3) (21.5) 55% Selling Expenses (28.2) (12.8) >100% G&A Expenses (10.3) (10.1) 2% Operating Profit / (Loss) (29.6) 203.5 >(100%) Consolidated Net Profit / (Net Loss) (41.6) 195.5 >(100%) Earnings per Share, basic and diluted (in €) (1.27) - - Earnings per Share, basic (in €) - 6.12 - Earnings per Share, diluted (in €) - 6.11 - On March 31, 2021 MorphoSys’ position in cash and investments amounted to Euros 1,215.0 million (December 31,2020: Euros 1,244.0 million)


Slide 13

© MorphoSys - Q1 2021 results Financial Guidance FY2021 *2020 Group Revenues include €236.1m upfront from Incyte, €18.5m Monjuvi sales, €42.5m Tremfya royalties, and €30.6m Milestones/other categories **Operating Expense does not include cost of sales; FY2020 number was adapted to include SG&A and R&D only Reported FY2020 Guidance FY2021 2021 Guidance Insights Group Revenues 327.7* 150 to 200 Includes confirmed EUR 16m otilimab milestones The range captures the potential for variability from the first full year of the Monjuvi product launch and the impact from the COVID-19 pandemic which is anticipated to be greater in the 1H21 Expect moderate y-y growth of Tremfya royalty revenue Excludes other potential significant milestones from development partners Operating Expense** 300.6** 355 to 385** Full year impact of Monjuvi selling expenses R&D Expense 141.4 45 to 50% of OpEx Investment in the development of tafasitamab, felzartamab, early-stage development programs, and technologies In € million


Slide 14

© MorphoSys - Q1 2021 results Q & A


Slide 15


Slide 16

© MorphoSys - Q1 2021 results Overview of Accounting for Co-Commercialization of Monjuvi in the U.S. 100% of Profit/Loss from Monjuvi co-commercialization is reflected on MorphoSys’ Income Statement 100% Monjuvi Net Product Sales 100% Monjuvi Cost of Sales Monjuvi Selling Expenses incurred by MorphoSys Monjuvi Selling Expenses incurred by Incyte MorphoSys Income Statement If result is a Loss: Incyte refunds MorphoSys 50% of Loss If result is a Profit: MorphoSys refunds Incyte 50% of Profit Income Statement Balance Sheet MorphoSys credits Cash and debits Financial Liability MorphoSys debits Cash and credits Financial Asset