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MorphoSys AG (NASDAQ: MOR) is a premier biopharmaceutical company headquartered in Planegg, Germany, with a significant presence in Boston, Massachusetts through its subsidiary MorphoSys US Inc. Established in 1992, the company focuses on the discovery, development, and commercialization of innovative therapies for cancer and autoimmune diseases. MorphoSys has made substantial strides in biopharmaceutical research and development, positioning itself as a leader in the industry.
One of MorphoSys' key achievements is the development of Tremfya (guselkumab), which is marketed by Janssen Biotech for the treatment of plaque psoriasis. It became the first drug based on MorphoSys' antibody technology to receive regulatory approval. Another significant product is Monjuvi (tafasitamab-cxix), which received accelerated approval from the U.S. Food and Drug Administration for the treatment of a certain type of lymphoma in combination with lenalidomide.
The company's latest financial update highlights preliminary Monjuvi U.S. net product sales of $92 million for 2023, with a gross margin of 69%. MorphoSys projects 2024 Monjuvi U.S. net product sales to be between $80 and $95 million. New indications for Monjuvi are currently being explored through Phase 3 trials.
MorphoSys continues to innovate with its clinical programs, such as pelabresib (CPI-0610), an investigational treatment for myelofibrosis. Following successful Phase 3 MANIFEST-2 trial results, MorphoSys is preparing regulatory filings for 2024.
In February 2024, MorphoSys announced a Business Combination Agreement with Novartis, which includes plans for Novartis to acquire MorphoSys and obtain exclusive rights to pelabresib and tulmimetostat. Concurrently, MorphoSys will transfer all rights related to tafasitamab to Incyte Corporation.
As MorphoSys continues to advance its pipeline and optimize operations, the company remains committed to bringing more life to people living with cancer. For further information, visit MorphoSys' website and follow them on Twitter and LinkedIn.
MorphoSys AG (FSE:MOR; NASDAQ:MOR) announced the successful outcome of its virtual Annual General Meeting held on May 18, 2022. Key resolutions included the discharge of Management and Supervisory Boards for the 2021 financial year, the appointment of PricewaterhouseCoopers as auditor for 2022, and the election of Andrew Cheng to the Supervisory Board. Shareholders also approved changes to Conditional and Authorized Capital and the remuneration system for the Management Board. The meeting saw 40.52% of the share capital represented, amid ongoing pandemic restrictions.
MorphoSys AG (NASDAQ: MOR) has announced the presentation of new clinical data on pelabresib and tafasitamab at the EHA 2022 and ASCO 2022 congresses. Key findings from the Phase 2 MANIFEST study will explore pelabresib's efficacy in treating myelofibrosis, a challenging bone marrow cancer, while the RE-MIND2 study will assess tafasitamab's impact on overall survival in relapsed or refractory diffuse large B-cell lymphoma patients. The EHA and ASCO meetings are scheduled from June 3-12, 2022, in Chicago and Vienna, respectively.
In Q1 2022, MorphoSys AG (MOR) reported U.S. net product sales of Monjuvi totaling US$ 18.7 million, marking a 21% year-over-year increase. However, total revenues fell to € 41.5 million, down 12% from € 47.2 million in Q1 2021 due to the absence of prior milestone payments. Operating loss expanded to € 68.0 million, up from € 29.6 million in the previous year, and consolidated net loss increased to € 122.7 million. The company maintains a cash position of € 846.9 million and anticipates ongoing growth driven by ongoing Phase 3 trials.
MorphoSys AG (FSE:MOR)(NASDAQ:MOR) will release its first quarter 2022 results on May 4, 2022 at 10:00 pm CEST. Following the results announcement, a conference call and webcast will take place on May 5, 2022 at 2:00 pm CEST. The management team will present the results and provide a 2022 outlook. Interested participants can access the live webcast and slides from the Investors section on MorphoSys' website. The company emphasizes its commitment to developing innovative treatments for cancer.
MorphoSys and Incyte received temporary approval from Swissmedic for Minjuvi (tafasitamab) in combination with lenalidomide. This approval is crucial for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), addressing an urgent medical need for approximately 500 patients diagnosed annually in Switzerland. The approval follows the L-MIND trial, showing a best objective response rate of 56.8% and a median duration of response of 43.9 months. This marks a significant milestone in providing new treatment options in this challenging condition.
MorphoSys reports U.S. net product sales of US$ 23.6 million for Q4 2021 and US$ 79.1 million for the full year 2021. The company achieved advancements in its pipeline with ongoing Phase 3 trials in myelofibrosis and DLBCL. Notably, cash stood at € 976.9 million as of December 31, 2021. However, MorphoSys faced a significant € 514.5 million net loss for the year, primarily due to acquisition-related costs and an impairment charge of € 230.7 million. Guidance for 2022 anticipates Monjuvi sales between US$ 110 million and 135 million.
MorphoSys announces that the National Comprehensive Cancer Network (NCCN) has updated its guidelines, designating Monjuvi (tafasitamab-cxix) in combination with lenalidomide as a Preferred Regimen for second-line therapy in Diffuse Large B-cell Lymphoma (DLBCL) patients not eligible for transplants. This update reflects new efficacy data, reinforcing Monjuvi’s position as a key treatment option for adult patients with relapsed or refractory DLBCL. Monjuvi, the only approved second-line targeted immunotherapy in the U.S. for this indication, initially received FDA approval in July 2020.
MorphoSys AG will announce its financial results for 2021 on March 16, 2022, at 9:00 PM CET. A conference call to discuss these results and provide 2022 outlook will take place on March 17, 2022, at 1:00 PM CET. Investors can join via the provided dial-in numbers or through a live webcast on MorphoSys' website. The event will include a management presentation followed by a Q&A session. For additional information, visit MorphoSys's website.
MorphoSys AG (FSE:MOR) announced a non-cash impairment charge of approximately €231 million on goodwill due to the consolidation of its research activities following the acquisition of Constellation Pharmaceuticals. The company will discontinue US-based discovery biology and drug discovery departments, impacting early pipeline projects and associated cash flows. This impairment will increase Group operating expenses for Q4 2021, with detailed results to be published on March 16, 2022. The write-down has no cash impact.
MorphoSys AG (FSE:MOR; NASDAQ:MOR) announced preliminary U.S. net product sales of Monjuvi for 2021 at US$ 79.1 million and projected sales for 2022 between US$ 110 to 135 million. The company reported US$ 23.6 million in sales for Q4 2021. Gross margins for 2022 are expected to be between 75% to 80%. R&D expenses are anticipated to rise to €300m to €325m due to pivotal studies, while SG&A expenses are expected to decrease despite initial high costs related to selling Monjuvi. Full-year 2021 results will be published on March 16, 2022.
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