EX-99.2 3 a230504_exhibit992.htm EX-99.2 a230504_exhibit992
Q1 2023 Results & Business Update May 4, 2023


 
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 tafasitamab/Minjuvi®). There is no guarantee any investigational product will be approved by regulatory authorities. Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Forward-Looking Statements 2© MorphoSys – Q1 2023 Results


 
3 Q&A Jean-Paul Kress, Tim Demuth, Joe Horvat (General Manager, U.S.) Financial Results & Guidance Julia Neugebauer, Ph.D., Vice President, Head of Investor Relations Development Update Tim Demuth, M.D., Ph.D., Chief Research & Development Officer (CR&DO) 04 03 01 Agenda 02 Q1 2023 Highlights & Outlook Jean-Paul Kress, M.D., Chief Executive Officer (CEO) © MorphoSys – Q1 2023 Results


 
Jean-Paul Kress, M.D. CEO Q1 2023 Highlights & Outlook 01 © MorphoSys – Q1 2023 Results


 
5© MorphoSys – Q1 2023 Results Phase 3 MANIFEST-2 Study of Pelabresib in First-Line Myelofibrosis Fully Enrolled Topline Data Available by End of 2023, Several Months Earlier Than Anticipated END OF 2023


 
f Pelabresib is a Potential Best- and First-in-Class, Foundational First-Line Myelofibrosis Treatment 6 Spleen Volume Anemia & Transfusion Dependence Bone Marrow Fibrosis Constitutional Symptoms Don’t Address All Four Hallmarks Only ~50% of patients achieve adequate control and responses are limited in duration Synergistic effects between BET inhibition and JAK inhibition SVR35 week 24: 68% TSS50 week 24: 56% Changes in biomarkers suggest disease-modifying effect Prolonged improvement in SVR35 and TSS50 at 40 and 60 weeks AVAILABLE TREATMENTS 1 2 3 © MorphoSys – Q1 2023 Results Mascarenhas J, et al. ASH 2022. Abstract 238. | Kleppe M, et al. Cancer Cell 2018;33:29–43.e7 4 Phase 2 Data Suggest Potential to Improve Standard of Care PELABRESIB + RUXOLITINIB


 
Monjuvi® Serves Critical DLBCL Patient Needs in Second-Line Setting, with Potential to Expand into First-Line Only FDA-approved, out-patient, in-practice immunotherapy for 2L+ adult NTE DLBCL in combination with lenalidomide © MorphoSys – Q1 2023 Results 7 $20.8M +11% YoY +13% demand Q1 2023 U.S. SALES PHASE 3 frontMIND TRIAL IN 1L ENROLLED NEW 5-YEAR EFFICACY & SAFETY 2L+ ANALYSIS Monjuvi® (tafasitamab-cxix) is approved under accelerated approval by the U.S. FDA in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT based on the one-year primary analysis of the Phase 2 L-MIND study; The data for the five-year analysis of the L-MIND study have not yet been submitted to, or reviewed by, the FDA; DLBCL: diffuse large B-cell lymphoma *Duell J, et al. AACR 2023. Abstract 9810; Based on Kaplan-Meier estimate 880+ Patients randomized H2 2025 Topline data available 40% of patients who received regimen were alive at five years*


 
DLBCL: diffuse large B-cell lymphoma. r/r FL / MZL: relapsed/refractory Follicular Lymphoma or Marginal Zone Lymphoma Rich Set of Pivotal Catalysts Through 2025 8 A S S E T D I S E A S E A R E A S T A T U S Pelabresib (MANIFEST-2) 1L Myelofibrosis Topline data available by end of 2023 Tafasitamab (frontMIND) 1L DLBCL Topline data available in H2 2025 Tafasitamab (inMIND) r/r FL / MZL Topline data available in 2024 A S S E T D I S E A S E A R E A S T A T U S Ianalumab (Novartis) Sjögren's Syndrome Lupus Nephritis and other autoimmune diseases Development program with several ongoing Phase 3 studies Abelacimab (Anthos Therapeutics) Venous Thromboembolism Prevention Development program with three ongoing Phase 3 studies Setrusumab (Ultragenyx / Mereo BioPharma) Osteogenesis Imperfecta Pivotal Phase 2/3 ongoing clinical study MORPHOSYS PIVOTAL STUDIES PARTNER PIVOTAL STUDIES © MorphoSys – Q1 2023 Results


 
Tim Demuth, M.D., Ph.D. CR&DO Development Update 02 © MorphoSys – Q1 2023 Results


 
10 STUDY POPULATION TREATMENT ARM/COHORT ENDPOINTSDESIGN/SIZE Topline data from MANIFEST-2 study expected by the end of 2023 Placebo + Ruxolitinib Pelabresib + Ruxolitinib JAK-inhibitor-naïve myelofibrosis patients Primary: SVR35 at 24 weeks Key Secondary: TSS50 at 24 weeks Double-Blind Randomization N=400 Phase 3 MANIFEST-2 Study Investigating Pelabresib Plus Ruxolitinib as a First-Line Myelofibrosis Treatment © MorphoSys – Q1 2023 Results More than 400 JAK-inhibitor-naïve patients were randomized in the MANIFEST-2 study


 
Longer-Term Data Suggest Deep and Durable Improvements in Spleen Volume and Symptom Score with Pelabresib plus Ruxolitinib Phase 2 MANIFEST trial results in JAK inhibitor-naïve patients presented at ASH 2022 11 SPLEEN VOLUME CHANGE OVER TIME TOTAL SYMPTOM SCORE CHANGE OVER TIME The most common hematologic adverse events (AE) were thrombocytopenia (55%, grade ≥3: 18%) and anemia (43%, grade ≥3: 34%). The most common nonhematologic AEs of any grade were diarrhea (43%), respiratory tract infection (41%), asthenic conditions (38%), musculoskeletal pain (32%), constipation (30%), nausea (29%), dizziness (27%) and abdominal pain (26%) Mascarenhas J, et al. ASH 2022. Abstract 238. © MorphoSys – Q1 2023 Results 0 12 24 36 48 60 84 Week N 82 79 71 64 57 -100 -50 0 50 100 150 200 % C h a n g e F ro m B a se lin e Mean N 77 73 67 63 55 53 20 10 0 -10 -20 -30 -40 -50 -70 -60 -80 -90 -100 0 12 Weeks24 36 48 60 72 M e a n % C h a n g e f ro m B a s e lin e (S D )


 
Patient A Patient B B a s e lin e W e e k 2 4 , C 9 D 1 Exploratory Biomarker Analysis from the MANIFEST Trial Suggests Potential Disease-Modifying Effect of Pelabresib plus Ruxolitinib Spleen response is associated with improvements in bone marrow morphology and reduction in JAK2 V617F allele frequency 12 Scandura J, et al. ASH 2022. Abstract 630. A lle le ra c ti o n % h a n g e T 5 emo esp A T 5 o es A grade improved onimproved mproved A emoglobin improved onimproved mproved es 35 o MEGAKARYOCYTE DECLUSTERING IN SVR35 RESPONDERS 38% OF PATIENTS REACHED ≥ % REDUCTION IN JAK2 V617F VAF © MorphoSys – Q1 2023 Results


 
Long-Term Data Suggest Curative Potential of Tafasitamab in Patients with Relapsed or Refractory DLBCL 13 Five-Year Results of Phase 2 L-MIND Study Showed Prolonged, Durable Responses © MorphoSys – Q1 2023 Results *Duell J, et al. AACR 2023. Abstract 9810; Based on Kaplan-Meier estimate mFU, median follow-up; mOS, median OS; NR, not reached; OS, overall survival; pLoT, prior line of therapy. The most common adverse events with combination therapy were neutropenia (incidence per person per year, all-grade/grade ≥3: 3.79/2. 9) and thrombocytopenia (1.52/0.52), which declined after patients switched to monotherapy (all- grade/grade ≥3: 1. 9/ .7 and .17/ . 6, respectively, in the first two years of monotherapy). Neutropenia and diarrhea were the most common adverse events in the first two years of monotherapy. 40% of patients who received regimen were alive at five years*


 
ASCO 2023 Data Underscore Strong Long-Term Potential of Pipeline Presentations feature new data on pelabresib in essential thrombocythemia and tulmimetostat in a broad array of advanced tumors 14© MorphoSys – Q1 2023 Results S T U D Y S E S S I O N T Y P E AB S T R AC T T I T L E P E LABRE S I B Phase 2 MANIFEST Arm 4 (essential thrombocythemia) Poster Discussion Pelabresib (CPI-0610) Monotherapy in High-Risk Essential Thrombocythemia Refractory or Intolerant to Hydroxyurea: Preliminary Results from MANIFEST Study T U L M IM E TO STAT Phase 2 Poster EZH2/EZH1 Inhibitor Tulmimetostat (CPI-0209) in Patients with Advanced Solid Tumors or Hematologic Malignancies: Preliminary Phase 2 results


 
04 Financial Results & Guidance Julia Neugebauer, Ph.D. Vice President, Head of Investor Relations © MorphoSys – Q1 2023 Results


 
Monjuvi® U.S. Product Sales and Minjuvi® Royalty Revenue 16 18.0 22.0 23.6 18.7 23.3 22.2 25.3 20.8 0.1 0.7 0.7 0.7 0.9 0.7 0.8 Q2 '21 Q3 '21 Q4 '21 Q1 '22 Q2 '22 Q3'22 Q4'22 Q1'23 Royalties from ex-U.S. Sales of Minjuvi U.S. Monjuvi Product Sales USD IN MILLION © MorphoSys – Q1 2023 Results


 
On March , , MorphoSys’ liquidity position amounted to € 79 . million (December , : € 9 7. million) Q1 2023: Profit or Loss Statement 17 In € million Q1 2023 Q1 2022 Δ Revenues 62.3 41.5 50% Product Sales 19.4 16.6 17% Royalties 21.6 19.0 14% Licenses, Milestones and Other 21.3 5.8 >100% Cost of Sales (21.0) (7.9) >100% Gross Profit 41.3 33.6 23% R&D Expenses (83.1) (65.0) 28% Selling Expenses (16.9) (21.9) (23)% G&A Expenses (10.9) (14.6) (25)% Total Operating Expenses (110.8) (101.5) 9% Operating Profit / (Loss) (69.5) (68.0) 2% Consolidated Net Profit / (Net Loss) (44.4) (122.7) (64)% Earnings per Share, basic and diluted (in €) (1.30) (3.59) (64)% © MorphoSys – Q1 2023 Results


 
Financial Guidance Full-Year 2023 18 Monjuvi U.S. Net Product Sales US$ 80m – 95m Gross Margin for Monjuvi U.S. Net Product Sales 75% – 80% R&D Expenses € 29 m – 315m SG&A Expenses € 14 m – 155m © MorphoSys – Q1 2023 Results


 
Q&A Tim Demuth, M.D., Ph.D., CR&DO 05 Jean-Paul Kress, M.D., CEO Joe Horvat General Manager, U.S. © MorphoSys – Q1 2023 Results


 
Thank you! www.morphosys.com © MorphoSys – Q1 2023 Results


 
Wnated Monjuvi® (tafasitamab-cxix) is approved under accelerated approval by the U.S. FDA in combination with lenalidomide for the treatment of adult patients with relapsed or refractory ]DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT; r/r DLBCL: relapsed/refractory diffuse large B-cell lymphoma. r/r FL / MZL: relapsed/refractory Follicular Lymphoma or Marginal Zone Lymphoma *Trial sponsored by Pfizer Best-In-Class Mid- to Late-Stage Oncology Pipeline 21 A S S E T P A R T N E R T A R G E T D I S E A S E A R E A P H A S E 1 P H A S E 2 P H A S E 3 M A R K E T Tafasitamab Incyte CD19 r/r DLBCL 1L DLBCL (frontMIND) r/r FL/MZL (inMIND) r/r DLBCL (with TTI-622)* Pelabresib BET 1L Myelofibrosis (MANIFEST-2) 1L/2L Myelofibrosis (MANIFEST) Tulmimetostat (CPI-0209) EZH2 Solid tumors/Lymphomas © MorphoSys – Q1 2023 Results


 
22 Euros in millions A B C A - B - C differences due to rounding IFRS Incyte Royalty Q1 2023 Collaboration Pharma Revenues 62,3 9,7 20,9 31,8 Monjuvi US product sales 19,4 9,7 1) 9,7 Royalties 21,6 20,9 5) 0,7 Other 21,3 21,3 Cost of Sales (20,9) (1,8) — (19,1) Cost of Sales US Monjuvi product sales (3,1) (1,8) 2) (1,3) Other (17,8) (17,8) Gross Profit 41,4 7,9 20,9 12,6 Gross Margin 66,5% 39,7% Total Operating Expenses: (110,8) (6,3) — (104,6) Research and Development (83,1) (83,1) Selling (16,9) (6,3) 3) (10,6) General and Administrative (10,9) (10,9) Impairment of Goodwill - — Operating Profit/(Loss) (69,4) 1,7 20,9 (91,9) Operating Margin -111,4% -289,4% Other Income 2,1 2,1 Other Expenses (1,8) (1,8) Finance Income 55,0 4,2 4) 28,2 6) 22,5 Finance Expenses (28,3) (3,1) 4) (20,5) 6) (4,7) Income from Reversals of Impairment Losses 0,5 0,5 Income Tax Benefit / (Expenses) - — Share of Loss of Associates accounted for using the Equity Method (2,5) (2,5) Consolidated Net Profit/(Loss) (44,3) 2,8 28,6 (75,7) EPS, Basic and Diluted (1,30) (2,22) EPS, Basic - - EPS, Diluted - - Shares Used for EPS, Basic and Diluted - 34.165.081 Shares Used for EPS, Basic 34.165.081 - Shares Used for EPS, Diluted 36.967.187 - 1Q 2023 Income Statement w/o Incyte 50/50 U.S. Profit Share and Transfers to Royalty Pharma © MorphoSys – Q1 2023 Results We supplement the consolidated statement of profit or loss presented in our earnings release with additional information on certain income or expense effects. The consolidated statement of profit or loss as well as the additional information in the earnings call slide deck are prepared in accordance with International Financial Reporting Standards (IFRS). The additional information relates to the contracts with Incyte and Royalty Pharma, namely to the accounting for the US co-commercialization with Incyte and the financing provided by Royalty Pharma which resulted in financial liabilities for payments owed to Royalty Pharma in future periods. The related effects are presented in two separate columns for various lines item of the consolidated statement of profit or loss. We believe this more detailed information provides additional insights into the financial performance of MorphoSys Group. The information given is in addition to, not a substitute for, or superior to, the measures of financial performance prepared in accordance with IFRS.


 
1Q 2022 Income Statement w/o Incyte 50/50 U.S. Profit Share and Transfers to Royalty Pharma 23 We supplement the consolidated statement of profit or loss presented in our earnings release with additional information on certain income or expense effects. The consolidated statement of profit or loss as well as the additional information in the earnings call slide deck are prepared in accordance with International Financial Reporting Standards (IFRS). The additional information relates to the contracts with Incyte and Royalty Pharma, namely to the accounting for the US co-commercialization with Incyte and the financing provided by Royalty Pharma which resulted in financial liabilities for payments owed to Royalty Pharma in future periods. The related effects are presented in two separate columns for various lines item of the consolidated statement of profit or loss. We believe this more detailed information provides additional insights into the financial performance of MorphoSys Group. The information given is in addition to, not a substitute for, or superior to, the measures of financial performance prepared in accordance with IFRS. Legend 1) Incyte's share of Monjuvi US sales, accounted for at MOR being the principal for this business 2) Incyte's share of cost of sales related to Monjuvi US sales, accounted for at MOR 3) Incyte's portion of Monjuvi US selling expenses, charged to/accounted for at MOR 4) Valuation effects from Incyte financial liability/asset (actual and planning cash flow adjustments, fx effects, interest expense) 5) Tremfya royalty paid to Royalty Pharma from Q2 2021 onward 6) Valuation effects from Royalty Pharma financial liability (actual and planning cash flow adjustments incl. fx effects, interest expense) Euros in millions A B C A - B - C differences due to rounding IFRS Incyte Royalty Q1 2022 Collaboration Pharma Revenues 41.5 8.3 18.4 14.7 Monjuvi US product sales 16.6 8.3 1) 8.3 Royalties 19.0 18.4 5) 0.6 Other 5.8 5.8 Cost of Sales (7.9) (1.3) - (6.6) Cost of Sales US Monjuvi product sales (3.5) (1.3) 2) (2.2) Other (4.4) (4.4) Gross Profit 33.6 7.0 18.4 8.1 Gross Margin 80.9% 55.4% Total Operating Expenses: (101.5) (11.5) - (90.0) Research and Development (65.0) (65.0) Selling (21.9) (11.5) 3) (10.4) General and Administrative (14.6) (14.6) Impairment of Goodwill - - Operating Profit/(Loss) (68.0) (4.5) 18.4 (81.9) Operating Margin -164% -557% Other Income 1.4 1.4 Other Expenses (3.7) (3.7) Finance Income 10.6 6.8 4) - 6) 3.8 Finance Expenses (62.8) (27.4) 4) (31.1) 6) (4.3) Income from Reversals of Impairment Losses (0.1) (0.1) Income Tax Benefit / (Expenses) - - Consolidated Net Profit/(Loss) (122.7) (25.1) (12.7) (84.9) EPS, Basic and Diluted (3.59) (2.49) EPS, Basic - - EPS, Diluted - - Shares Used for EPS, Basic 34.15 34.15 Shares Used for EPS, Diluted © MorphoSys – Q1 2023 Results


 
4Q 2022 Income Statement w/o Incyte 50/50 U.S. Profit Share and Transfers to Royalty Pharma 24 We supplement the consolidated statement of profit or loss presented in our earnings release with additional information on certain income or expense effects. The consolidated statement of profit or loss as well as the additional information in the earnings call slide deck are prepared in accordance with International Financial Reporting Standards (IFRS). The additional information relates to the contracts with Incyte and Royalty Pharma, namely to the accounting for the US co-commercialization with Incyte and the financing provided by Royalty Pharma which resulted in financial liabilities for payments owed to Royalty Pharma in future periods. The related effects are presented in two separate columns for various lines item of the consolidated statement of profit or loss. We believe this more detailed information provides additional insights into the financial performance of MorphoSys Group. The information given is in addition to, not a substitute for, or superior to, the measures of financial performance prepared in accordance with IFRS. Euros in millions A B C A - B - C differences due to rounding IFRS Incyte Royalty Q4 2022 Collaboration Pharma Revenues 81,6 12,3 28,4 40,9 Monjuvi US product sales 24,7 12,3 1) 12,3 Royalties 29,1 28,4 5) 0,7 Other 27,9 27,9 Cost of Sales (15,4) (2,1) — (13,3) Cost of Sales US Monjuvi product sales (10,3) (2,1) 2) (8,2) Other (5,1) (5,1) Gross Profit 66,2 10,2 28,4 27,6 Gross Margin 81,1% 67,5% Total Operating Expenses: (134,6) (9,4) — (125,2) Research and Development (94,0) (94,0) Selling (23,0) (9,4) 3) (13,6) General and Administrative (17,5) (17,5) Impairment of Goodwill - — Operating Profit/(Loss) (68,4) 0,8 28,4 (97,6) Operating Margin -83,8% -238,8% Other Income (7,8) (7,8) Other Expenses 7,4 7,4 Finance Income 325,0 312,8 4) 18,4 6) (6,2) Finance Expenses 249,5 44,6 4) 212,3 6) (7,3) Income from Reversals of Impairment Losses 0,4 0,4 Income Tax Benefit / (Expenses) (172,7) (172,7) Share of Loss of Associates accounted for using the Equity Method (4,0) (4,0) Consolidated Net Profit/(Loss) 329,5 358,2 259,1 (287,9) EPS, Basic and Diluted (in €) - (8,43) EPS, Basic (in €) 9,64 - EPS, Diluted (in €) 8,93 - Shares Used for EPS, Basic and Diluted - 34.165.081 Shares Used for EPS, Basic 34.165.081 - Shares Used for EPS, Diluted 36.967.187 - © MorphoSys – Q1 2023 Results