On May 3, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported results for the first quarter of 2023 (Press release, MorphoSys, MAY 3, 2023, View Source [SID1234630954]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We had a strong first quarter, marked by numerous achievements. Most importantly, we completed enrollment of our Phase 3 MANIFEST-2 study of pelabresib in first-line myelofibrosis ahead of schedule. As a result, the topline data from the trial are now expected by the end of 2023, months earlier than previously anticipated," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We continue to focus our work on our most-advanced clinical programs that have the potential to create near-term value for all stakeholders. We look forward to building on this great momentum in 2023 and the years ahead."
Monjuvi/Minjuvi Highlights:
Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 20.8 million (€ 19.4 million) for the first quarter 2023 (Q1 2022: US$ 18.7 million (€ 16.6 million)).
Minjuvi royalty revenue of € 0.7 million for sales outside of the U.S. in the first quarter 2023 (Q1 2022: € 0.7 million).
Corporate Developments:
On March 2, 2023, MorphoSys announced that it will stop work and operations on its pre-clinical research programs to optimize its cost structure. MorphoSys reduced its workforce at the company’s headquarters in Planegg, Germany, by approximately 17%. This action, along with other steps taken over the past year, enables MorphoSys to focus resources on its mid- to late-stage oncology pipeline.
On March 14, 2023, MorphoSys announced that Lucinda Crabtree, Ph.D., will join the company as its Chief Financial Officer and member of the Management Board in the third quarter of 2023 at the latest.
Charlotte Lohmann was appointed as Chief Legal Officer on March 1, 2023 and will serve as a member of MorphoSys’ Management Board ad interim.
On March 30, 2023, MorphoSys settled the repurchase of bonds in the value of € 62.9 million (approximately 19 % of the outstanding principal amount) resulting in an outstanding aggregate principal amount of the convertible bonds of € 262.1 million.
Significant Events After the End of the First Quarter of 2023:
Pelabresib:
On April 4, 2023, MorphoSys announced that enrollment is complete for MANIFEST-2, the ongoing Phase 3 study exploring the efficacy and safety of pelabresib, an investigational BET inhibitor, in combination with ruxolitinib versus ruxolitinib alone in patients with myelofibrosis who have not previously been treated with a JAK inhibitor (JAK inhibitor-naïve). More than 400 patients were enrolled in this study. The topline data are now expected by the end of 2023, earlier than previously anticipated.
Tafasitamab:
On April 4, 2023, MorphoSys announced that enrollment of the Phase 3 frontMIND study is also complete, with more than 880 patients enrolled in the trial. frontMIND is a global, multicenter, randomized, double-blind, placebo-controlled trial exploring tafasitamab, marketed in the U.S. as Monjuvi and outside the U.S. by Incyte as Minjuvi, plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP alone as a first-line treatment for high-intermediate and high-risk patients with diffuse large B-cell lymphoma (DLBCL). The topline data from this study are expected in the second half of 2025.
Conference Data Highlight:
On April 16, 2023, MorphoSys and Incyte announced final five-year follow-up data from the Phase 2 L-MIND study showing that Monjuvi (tafasitamab-cxix) plus lenalidomide followed by Monjuvi monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory DLBCL. These data were featured as a late-breaking oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023.
New data on pelabresib in essential thrombocythemia and tulmimetostat in a broad array of advanced tumors will be featured in two poster presentations during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Financial Results for the First Quarter of 2023 (IFRS):
Total revenues for the first quarter 2023 were € 62.3 million compared to € 41.5 million for the same period in 2022. This increase resulted mainly from higher revenues from the sale of clinical vials.
in € million*
Q1 2023
Q4 2022
Q1 2022
Q-Q Δ
Y-Y Δ
Total revenues
62.3
81.6
41.5
(24) %
50 %
Monjuvi product sales
19.4
24.7
16.6
(21) %
17 %
Royalties
21.6
29.1
19.0
(26) %
14 %
Licenses, milestones and other
21.3
27.9
5.8
(24) %
> 100%
* Differences due to rounding.
Cost of Sales: Cost of sales in the first quarter of 2023 amounted to € 21.0 million (Q1 2022: € 7.9 million). The year-on-year increase resulted primarily from expenses related to vial sales to Incyte. Cost of sales related to Monjuvi U.S. product sales amounted to € 3.1 million in the first quarter of 2023. The gross margin of Monjuvi U.S. net product sales amounted to 84% (Q1 2022: 79%).
Research and Development (R&D) Expenses: In the first quarter 2023, R&D expenses were € 83.1 million (Q1 2022: € 65.0 million). The increase mainly resulted from additional costs incurred due to the positive development of the patient recruitment in the major ongoing clinical studies of MorphoSys. Additionally, the first quarter of 2023 included a one-time effect resulting from severances in connection with the restructuring of the research area.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the first quarter 2023 were € 16.9 million (Q1 2022: € 21.9 million). The decrease was driven by streamlining and focusing of selling efforts. General and administrative (G&A) expenses amounted to € 10.9 million (Q1 2022: € 14.6 million).
Operating Loss: Operating loss amounted to € 69.5 million in the first quarter 2023 (Q1 2022: operating loss of € 68.0 million).
Consolidated Net Loss: For the first quarter 2023, consolidated net loss was € 44.4 million (Q1 2022: consolidated net loss of € 122.7 million).
Full Year 2023 Financial Guidance:
Amounts in million
2023 Financial Guidance
2023 Guidance Insights
Monjuvi U.S. net
product sales
US$ 80m to 95m
100% of Monjuvi U.S. net product sales are recorded
on MorphoSys’ income statement and
related profit/loss is split 50/50 between
MorphoSys and Incyte.
Gross margin for
Monjuvi U.S. net
product sales
75% to 80%
100% of Monjuvi U.S. product cost of sales are
recorded on MorphoSys’ income statement and
related profit/loss is split 50/50 between
MorphoSys and Incyte.
R&D expenses
€ 290m to 315m
2023 anticipated to be incrementally higher than
2022 due to the expansion of the pelabresib
development program.
SG&A expenses
€ 140m to 155m
45% to 50% of mid-point of SG&A expenses
represent Monjuvi U.S. selling costs of which
100% are recorded in MorphoSys’ income
statement. Incyte reimburses MorphoSys for half
of these selling expenses.
Additional information related to 2023 Financial Guidance:
Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys, as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2023.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. MorphoSys does not provide guidance for these sales.
Operational Outlook:
The following events and development activities planned for 2023 and beyond include the following:
topline results for the pivotal Phase 3 study (MANIFEST-2) of pelabresib in myelofibrosis (MF) by the end of 2023;
primary analysis data from the Phase 3 study (inMIND) of tafasitamab in patients with indolent lymphoma (r/r FL/MZL) in 2024;
primary analysis data from the pivotal Phase 3 study (frontMIND) of tafasitamab in previously untreated DLBCL in the second half of 2025.
MorphoSys Group Key Figures (IFRS, end of the first quarter: March 31, 2023)
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 %
Total Operating Expenses
(110.8)
(101.5)
9 %
Research and Development
(83.1)
(65.0)
28 %
Selling
(16.9)
(21.9)
(23) %
General and Administrative
(10.9)
(14.6)
(25) %
Operating Profit / (Loss)
(69.5)
(68.0)
2 %
Other Income
2.1
1.4
50 %
Other Expenses
(1.8)
(3.7)
(51) %
Finance Income
55.0
10.6
>100%
Finance Expenses
(28.3)
(62.8)
(55) %
Income from Reversals of Impairment Losses / (Impairment Losses) on
Financial Assets
0.5
(0.1)
>(100)%
Share of Loss of Associates accounted for using the Equity Method
(2.5)
—
n/a
Income Tax Benefit / (Expenses)
0.0
0.0
n/a
Consolidated Net Profit / (Loss)
(44.4)
(122.7)
(64) %
Earnings per Share, Basic and Diluted (in €)
(1.30)
(3.59)
(64) %
Cash and other financial assets (end of period)
791.5
907.2 *
(13) %
* Value as of December 31, 2022
MorphoSys will hold its conference call and webcast tomorrow, May 04, 2023, at 2:00pm CEST (1:00pm GMT/8:00am EST) to present the results for the first quarter 2023.
Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call:
View Source;linkSecurityString=77dbe4aa2
Please dial in 10 minutes before the beginning of the conference.
A live webcast and slides will be made available at the Investors section under "Events & Conferences" on MorphoSys’ website, View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.
The statement for the first quarter 2023 (IFRS) is available for download at:
View Source/en/investors/financial-information