MORPHOSYS AG DGAP-News: MorphoSys AG / Key word(s): Half Year Results MorphoSys AG Reports Second Quarter and First Half 2021 Results 2021-07-28 / 22:03 The issuer is solely responsible for the content of this announcement. =---------------------------------------------------------------------------------------------------------------------- Media Release MorphoSys AG Reports Second Quarter and First Half 2021 Results - Monjuvi U.S. net product sales of EUR 14.9 million (USUSD 18.0 million), 16% growth Q-Q - MorphoSys announced and subsequently completed its acquisition of Constellation Pharmaceuticals - Announced and closed USUSD 2.0 billion strategic funding partnership with Royalty Pharma - Updated group financial guidance - Conference call and webcast (in English) tomorrow, July 29, 2021, at 2:00pm CEST (1:00pm BST/8:00am EDT) MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports financial results for the second quarter and the first half year of 2021. "We regained the momentum in Monjuvi sales as we exited the second quarter and are encouraged to see that momentum continuing into Q3," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are seeing the positive impact to our business from the vaccination rollout in the U.S., and remain focused on establishing tafasitamab as a standard of care in the treatment of patients with relapsed/refractory DLBCL." "With the addition of Constellation's clinical programs to our pipeline, we are in a great position to build a significant presence in hematology-oncology with multiple commercial opportunities." Tafasitamab Highlights - Monjuvi^(R) (tafasitamab-cxix) U.S. net product sales of EUR 14.9 million (USUSD 18.0 million) for the second quarter of 2021 and EUR 27.8 million (USUSD 33.5 million) for the first half of 2021. - On April 19, 2021, MorphoSys and Incyte announced that the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). - On May 11, 2021, MorphoSys and Incyte announced that the first patient was dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). - From June 4-8, 2021, MorphoSys presented new data from the tafasitamab development program at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Data from the three-year follow-up from the Phase 2 L-MIND study showed a long durability of responses and overall survival in patients with r/r DLBCL. - On June 25, 2021, MorphoSys and Incyte announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization for tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). The Committee for Orphan Medicinal Products (COMP) has also confirmed the orphan drug designation status in mid-July. - Together with MorphoSys, Incyte plans to start coreMIND, a pivotal Phase 2 study that will assess tafasitamab in combination with Incyte's Pi3 kinase delta inhibitor in patients with chronic lymphocytic leukemia (CLL). - MorphoSys will also initiate MINDway, a study that will look into finding the best treatment schedule for patients with Non-Hodgkin Lymphoma (NHL) who benefit from long-term disease-control from tafasitamab. Acquisition of Constellation Pharmaceuticals and Strategic Funding Partnership - On June 2, 2021, MorphoSys entered into a definitive agreement to acquire Constellation Pharmaceuticals (Constellation) for USUSD 34.00 per share in cash, which represents a total equity value of USUSD 1.7 billion. The transaction has been unanimously approved and subsequently was completed on July 15, 2021. - MorphoSys gets access to mid- to late-stage product candidates: Pelabresib (CPI 0610) has the potential to be a first-in-class and best-in-class BET inhibitor that is currently being evaluated in a Phase 3 trial for the treatment of myelofibrosis. CPI-0209 is a mid-stage EZH2 inhibitor, which is currently in a Phase 2 clinical trial and has best-in-class potential for treating both hematologic and solid tumors. - MorphoSys entered into a long-term strategic funding partnership with Royalty Pharma: - USUSD 1.425 billion upfront payment - Up to USUSD 350 million in Development Funding Bonds - Up to USUSD 150 million milestone payments - Royalty Pharma Investments 2019 ICAV, a subsidiary of Royalty Pharma plc, purchased USUSD 100 million in shares (1,337,552 shares) of MorphoSys at a price of EUR 63.35 per share on July 16, 2021 - MorphoSys also announced today that Jigar Raythatha, President and Chief Executive Officer of Constellation, will resign effective July 31, 2021. Barbara Krebs-Pohl, PhD, Senior Vice President, Global Head of Business Development, Licensing, and Alliance Management at MorphoSys, has been appointed as Site Head of Constellation and Chief Integration Officer. Tremfya: - MorphoSys to continue to record Tremfya royalties on its income statement. Royalty Pharma is entitled to receive 100 percent of Tremfya royalties starting with royalties for the second quarter of 2021. - Tremfya royalties of EUR 13.7 million for the second quarter of 2021 and EUR 25.4 million for the first half of 2021. Financial Results for the Second Quarter of 2021 (IFRS) Total revenues for the second quarter of 2021 amounted to EUR 38.2 million (Q2 2020: EUR 18.4 million). The revenues include success-based payments of EUR 14.2 million, primarily from Janssen (Q2 2020 success-based payments: EUR 12.8 million). in EUR million Q2 2021 Q2 2020 Change Total revenues 38.2 18.4 >100% Monjuvi product sales 14.9 - - Royalties 13.7 10.8 27% Licenses, milestones and other 9.6 7.6 26%
Cost of Sales: In the second quarter of 2021, cost of sales increased to EUR 10.1 million (Q2 2020: income of EUR 7.2 million).
Research and Development (R&D) Expenses: In the second quarter of 2021, research and development expenses were EUR 40.5 million (Q2 2020: EUR 30.9 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.
Selling, General and Administrative (SG&A) Expenses: Selling expenses decreased slightly in the second quarter of 2021 to EUR 28.5 million (Q2 2020: EUR 29.3 million) and general and administrative expenses amounted to EUR 30.5 million (Q2 2020: EUR 13.8 million). The increase of general and administrative expense in the second quarter was due to the transaction costs related to the Constellation and Royalty Pharma agreements.
Operating Loss: Operating loss amounted to EUR 71.4 million in the second quarter of 2021 (Q2 2020: operating loss of EUR 48.4 million).
Consolidated Net Profit / Loss: For the second quarter of 2021, consolidated net profit was EUR 20.9 million (Q2 2020: consolidated net loss of EUR 53.1 million). Financial Results for the First 6 Months of 2021 (IFRS)
Total revenues for the first six months of 2021 amounted to EUR 85.4 million (H1 2020: EUR 269.7 million). The revenues include success-based payments of EUR 43.1 million, primarily from Janssen (H1 2020 success-based payments: EUR 23.1 million) The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte in the first quarter 2020 for the out-licensing of tafasitamab outside the U.S.
in EUR million* H1 2021 H1 2020 Change Total revenues 85.4 269.7 (68%) Monjuvi product sales 27.8 - - Royalties 25.4 20.1 26% Licenses, milestones and other 32.3 249.5 (87%)
*Differences due to rounding
Cost of Sales: In the first six months of 2021, cost of sales increased to EUR 15.2 million (H1 2020: income of EUR 4.0 million).
Research and Development (R&D) Expenses: In the first six months of 2021, research and development expenses were EUR 73.8 million (H1 2020: EUR 52.4 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.
Selling, General and Administrative (SG&A) Expenses: Selling expenses increased in the first six months of 2021 to EUR 56.6 million (H1 2020: EUR 42.1 million) and general and administrative expenses amounted to EUR 40.8 million (H1 2020: EUR 23.9 million). The year-over-year increase in selling expenses was primarily driven by the full first half year 2021 impact of the expenses for services provided by Incyte as part of the joint U.S. marketing activities for Monjuvi. The year-over-year increase in general and administrative expenses was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements.
Operating Loss: Operating loss amounted to EUR 101.0 million in the first six months of 2021 (H1 2020: operating profit of EUR 155.1 million).
Consolidated Net Profit / Loss: For the first six months of 2021, consolidated net loss was EUR 20.7 million (H1 2020: consolidated net profit of EUR 179.8 million).
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