EX-99.1 2 d786425dex991.htm EXHIBIT 99.1 Exhibit 99.1
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Exhibit 99.1

Half-Year Report

January – June 2019

 

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Summary of the Second Quarter of 2019

FINANCIAL RESULTS FOR THE FIRST HALF OF 2019

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Group revenue in the first half of 2019 totaled € 48.2 million (Q1-Q2 2018: € 10.9 million), and EBIT amounted to € -29.3 million (Q1-Q2 2018: € -43.2 million).

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The Group’s liquidity position on June 30, 2019, was € 409.2 million (December 31, 2018: € 454.7 million).

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On July 3, 2019, MorphoSys raised its financial guidance in connection with the milestone payment of € 22 million by GSK for the start of a phase 3 program with otilimab (MOR103/GSK3196165). For 2019, MorphoSys now expects revenues in the range of € 65 to € 72 million (previous guidance: € 43 to € 50 million) and earnings before interest and taxes (EBIT) of € -105 to € -115 million (previous guidance: € -127 to € -137 million). Expected R&D expenses for proprietary programs and technology development remain unchanged in the amount of € 95 to € 105 million.

OPERATING HIGHLIGHTS FOR THE SECOND QUARTER OF 2019

PROPRIETARY DEVELOPMENT

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In April, tafasitamab has been selected by WHO as the recommended International Nonproprietary Name (INN) for MOR208 and has now also been assigned by the United States Adopted Names (USAN) Council as nonproprietary name in the U.S.

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On May 16, 2019, MorphoSys announced results from the primary analysis of the L-MIND study of tafasitamab (MOR208) in combination with lenalidomide in relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). These results provide an overall confirmation of the strong data previously published for this study. The objective response rate (ORR) was 60%, and the complete response rate (CR) was 43%. The median progression-free survival (mPFS) was 12.1 months, with a median follow-up period of 17.3 months. The medium duration of response (mDoR) was 21.7 months.

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On June 22, 2019, detailed results of the primary analysis of the L-MIND study were presented at the 15th International Conference on Malignant Lymphoma (15th ICML) in Lugano, Switzerland. In addition to the topline data reported on May 16, 2019, data on median overall survival (OS) and the safety profile of the treatment were presented. OS was not yet reached (NR) (95% CI 18.3 months - NR) with a median follow-up time of 19.6 months. The 12-month OS rate was 73.3%. No unexpected toxicities from the combination treatment were observed. Infusion-related reactions (IRRs) for tafasitamab were reported for only 6% of the patients and limited to grade 1. The most frequent treatment-emergent adverse events (TEAEs) with a grade of 3 or higher were neutropenia in 48%, thrombocytopenia in 17% and anemia in 7% of patients.

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On April 23, 2019, MorphoSys, Galapagos and Novartis announced the initiation of GECKO, a phase 2 study of a subcutaneous formulation of MOR106 in combination with topical corticosteroids. Patient recruitment will take place in the U.S. and Canada, and the study is intended to serve as an Investigational New Drug (IND) opener with the U.S. Food and Drug Administration (FDA).

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On April 29, 2019, MorphoSys and I-Mab announced the start of a phase 3 clinical study in Taiwan to evaluate MorphoSys’s human CD38 antibody MOR202/TJ202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma. The dosing of the first patients triggered a milestone payment of US-$ 3 million to MorphoSys.

 

                

 

 

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In April, Merck Serono announced that the co-development and licensing agreement with MorphoSys will be terminated in the second quarter of 2019. The collaboration between Merck Serono and MorphoSys included programs in the early stages of drug discovery. The termination of the collaboration has no material impact on MorphoSys.

PARTNERED DISCOVERY

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On April 15, 2019, MorphoSys announced that its licensee Janssen had further expanded the clinical development of Tremfya® into familial adenomatous polyposis (FAP), a disease of the gastrointestinal tract. MorphoSys received a milestone payment from Janssen in connection with the start of clinical development in FAP.

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On June 14, 2019, MorphoSys announced that licensee Janssen reported that the ongoing phase 3 studies of Tremfya® in psoriatic arthritis had each met their primary endpoints. Data from both studies will serve as the basis of submissions planned later this year to the U.S. FDA and the European Medicines Agency (EMA).

CORPORATE DEVELOPMENTS

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The Annual General Meeting of MorphoSys AG on May 22, 2019 re-elected Krisja Vermeylen and elected Sharon Curran as a new member of the Company’s Supervisory Board.

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On June 24, 2019, Dr. Jean-Paul Kress was appointed as the new Chief Executive Officer (CEO) by the Supervisory Board, effective September 1, 2019. In his new position, Dr. Kress will succeed Dr. Simon Moroney, who will step down as CEO on September 1, 2019. Dr. Moroney will support Dr. Kress during a transition period.

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On June 25, 2019, MorphoSys presented the members of the U.S. management team to analysts and investors in New York as part of a “Meet the Team” event.

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At the end of the second quarter of 2019, the MorphoSys pipeline comprised a total of 119 drug candidates, 29 of which are in clinical development.

 

                

 

 

                       MorphoSys – II/2019


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SIGNIFICANT EVENTS AFTER THE END OF THE SECOND QUARTER OF 2019

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On July 3, 2019, GlaxoSmithKline (GSK) announced the initiation of a phase 3 clinical development program with MOR103/GSK3196165 in rheumatoid arthritis (RA). The dosing of the first patient triggered a milestone payment of € 22 million to MorphoSys. In connection with the notification, GSK also announced that the antibody had been assigned the INN name otilimab.

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On July 8, 2019, MorphoSys and Vivoryon Therapeutics AG announced that they have entered into an agreement under the terms of which MorphoSys has obtained an exclusive option to license Vivoryon’s small molecule QPCTL inhibitors in the field of oncology. The option covers worldwide development and commercialization for cancer of Vivoryon’s family of inhibitors of the glutaminyl-peptide cyclotransferase-like (QPCTL) enzyme, including its lead compound PQ912. In exchange, MorphoSys has committed to investing up to € 15 million in a minority stake in Vivoryon Therapeutics as part of a capital raise planned for later this year.

 

                

 

 

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MORPHOSYS PRODUCT PIPELINE AS OF JULY 23, 2019

Most Advanced Development Stage                                                     

 

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                       MorphoSys – II/2019


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Interim Group Management Report:

January 1 – June 30, 2019

Business Environment and Activities

ECONOMIC DEVELOPMENT

The International Monetary Fund (IMF) expects the global economy to expand in 2019. Global economic output is projected to increase by 3.3% in 2019 and 3.6% in 2020. Last year, global growth was 3.6%. Underlying the slowdown in economic growth were, among other factors, trade disputes between the U.S. and China and the slowdown in economic growth in Europe. The IMF is forecasting growth of 0.8% in the current year in Germany, 1.3% in the eurozone and 2.3% in the U.S.

The German DAX index, as well as the MDAX index consisting of medium-sized companies and the TecDAX technology index performed positively in the first half of 2019. Political uncertainties and changes in some countries’ economic policies, however, continued to cause volatility on the stock markets. The trade dispute between the U.S. and its trading partner China, in particular, as well as the impact of this dispute on the European Union, have led to heightened uncertainty.

IMPLICATIONS FOR MORPHOSYS

The economic developments described above had little impact on MorphoSys’s operating performance in the first six months of 2019. The MorphoSys share started 2019 with a strong upward trend, reaching its preliminary high of € 105.00 on January 25. During the remainder of the first half of the year, however, the share’s volatility increased, closing at € 84.45 on June 28, 2019.

SECTOR OVERVIEW

The first half of 2019 was highlighted by key medical conferences where pharmaceutical and biotechnology companies present the results of their research. The world’s largest oncology conference, the annual meeting of the American Society of Clinical Oncology (ASCO), took place in early June 2019 in Chicago, followed by the leading European hematology conference, the 24th Annual Meeting of the European Hematology Association (EHA) in Amsterdam, the Netherlands, from June 13-16, 2019. In addition, the 15th International Conference on Malignant Lymphoma (15-ICML) was held in Lugano, Switzerland, from June 18-22, 2019. MorphoSys presented clinical results from its tafasitamab (MOR208) drug program at all three conferences, focusing on the presentation of data from the primary analysis of the L-MIND study at the 15-ICML.

BUSINESS PERFORMANCE

MorphoSys is pleased with the Company’s business performance in the first half of 2019, not only in terms of its proprietary pipeline and partnered discovery activities, but also in the Group’s development.

In the second quarter, MorphoSys announced the results of the primary analysis of the L-MIND study (cut-off date November 30, 2018) of its proprietary compound tafasitamab (MOR208) in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).

 

                

 

 

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The results confirm the overall strong data already reported for this study. MorphoSys is in close interaction with the FDA in an effort to complete a regulatory filing in the United States by the end of this year. In addition, I-Mab initiated two pivotal trials in the first half of the year to investigate MOR202/TJ202 in patients with relapsed or refractory multiple myeloma. “GECKO”, a phase 2 trial, was started for the drug candidate MOR106, investigating the antibody in combination with topical corticosteroids in patients with moderate to severe atopic dermatitis. With the antibody otilimab (formerly MOR103/GSK3196165) GSK announced the start of a clinical phase 3 development program in rheumatoid arthritis at the beginning of July. The dosing of the first patient triggered a milestone payment of € 22 million to MorphoSys.

MorphoSys also received good news in the first half of the year from its Partnered Discovery segment. Janssen reported that both ongoing phase 3 studies that examine the efficacy and safety of Tremfya® in patients with moderate-to-severe psoriatic arthritis had reached their primary endpoints. The data from the two studies will serve as the basis for regulatory filings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Moreover, Janssen also expanded the clinical development of Tremfya® with the start of clinical trials in the indications ulcerative colitis and familial adenomatous polyposis (FAP).

At the end of the second quarter of 2019, MorphoSys’s product pipeline comprised a total of 119 partnered and proprietary programs, 29 of which were in clinical development.

In the opinion of the Management Board, at the time of publishing this half-year report, MorphoSys was on track to reach its business and financial targets for the full year which have been adapted at the beginning of July.

STRATEGY AND GROUP MANAGEMENT

MorphoSys has made no changes to its strategy or Group management during the first six months of 2019. A full description of the strategy and the Group management can be found on page 25 of the 2018 Annual Report.

Research and Development and Operating Business Performance

PROPRIETARY DEVELOPMENT

MorphoSys’s proprietary development activities are currently focused on four clinical candidates:

 

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the hemato-oncological program tafasitamab (MOR208), for which MorphoSys holds worldwide commercial rights;

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the hemato-oncological program MOR202, for which MorphoSys concluded a regional licensing agreement with I-Mab in November 2017 for development in China, Hong Kong, Taiwan and Macao;

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the antibody MOR106, co-developed with Galapagos for treating inflammatory diseases for which a global license agreement was signed with Novartis in July 2018; and

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the lanthipeptide MOR107 developed by MorphoSys’s Dutch subsidiary Lanthio Pharma.

GlaxoSmithKline (GSK) is currently conducting clinical tests of otilimab (MOR103/GSK3196165) for the treatment of rheumatoid arthritis. The program originated as a proprietary MorphoSys program and was out-licensed to GSK.

 

                

 

 

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Tafasitamab (MOR208) is an investigational Fc-engineered therapeutic antibody targeting CD19, a molecule that can be found on the surface of certain blood cancer cells, that is being developed for the treatment of B cell malignancies. MorphoSys is currently investigating tafasitamab in three clinical studies in combination with other cancer drugs in the indications DLBCL and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In addition to the three ongoing studies, MorphoSys is currently evaluating a broadening or extension of the tafasitamab clinical development program to other indications, in other combinations and/or additional treatment lines.

The main focus of the current tafasitamab development program is on relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). Two of the three ongoing tafasitamab studies, namely the L-MIND and B-MIND trials, are being conducted in this indication. Both trials are focusing on r/r DLBCL patients who are not eligible for high-dose chemotherapy (HDC) and subsequent autologous stem cell transplantation (ASCT). The available therapy options for this group of patients are currently very limited, which is why the Company sees a high unmet medical need for new treatment alternatives.

The phase 2 L-MIND study (Lenalidomide – MOR208 IN DLBCL), initiated in April 2016, is designed as an open-label, single-arm study with the primary endpoint being the objective response rate (ORR) and multiple secondary endpoints, including progression-free survival (PFS), overall survival (OS) and time to progression (TTP). Based on interim results from the L-MIND study, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation status in October 2017 for tafasitamab in combination with lenalidomide. The recruitment of all patients was completed in November 2017. In the second quarter of the reporting year, topline results of the primary analysis were published (cut-off date November 30, 2018 and a follow-up period of at least 12 months for all patients). Detailed data were presented on June 22, 2019 at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. Efficacy results in this update were based on response rates in all 80 patients, as assessed by an independent review committee. The primary endpoint, defined as the best objective response rate (ORR) compared to published data on the respective monotherapies, was met. The ORR was 60% (48 out of 80 patients), and the complete response (CR) rate was 43% (34 out of 80 patients). 82% of the CRs were PET (positron emission tomography) confirmed. The median progression-free survival (mPFS) was 12.1 months with a median follow-up of 17.3 months. Responses were durable with a median duration of response (DoR) of 21.7 months. Median overall survival (OS) was not reached (NR) (95% CI 18.3 months - NR) with a median follow-up time of 19.6 months. The 12-month OS rate was 73.3%. Efficacy parameters, such as response rates, showed comparable results in most patient subgroups of interest, including rituximab refractory versus non-refractory and primary refractory versus non-primary refractory patients.

The L-MIND treatment combination was generally well tolerated in this study; infusion-related reactions (IRRs) for tafasitamab were reported for only 6% of the patients and were limited to grade 1. The most frequent treatment-emergent adverse events (TEAEs) with a grade of 3 or higher were neutropenia in 48% of patients, thrombocytopenia in 17% and anemia in 7%. Treatment-related serious adverse events (SAEs) occurred in 15 (18.5%) patients, the majority of which were infections or neutropenic fever. A total of 37 patients (43%) required dose reduction with lenalidomide, and 62 patients (78%) were able to remain on a daily dose of lenalidomide of 20 mg or higher.

The results of the primary analysis confirmed the strong overall data previously reported for this study. An application for approval is expected to be submitted to the FDA by the end of the year.

 

                

 

 

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Parallel to these results, discussions were held with European regulators to explore the possibility of using the L-MIND study as a basis for regulatory approval in Europe.

The phase 2/3 study named B-MIND (Bendamustine – MOR208 IN DLBCL) initiated in September 2016 is designed to evaluate the safety and efficacy of tafasitamab combined with the chemotherapeutic agent bendamustine in comparison to the cancer drug rituximab plus bendamustine in patients with r/r DLBCL. The study has been in the phase 3 part since mid-2017. In the first quarter of 2019, MorphoSys had implemented a secondary co-primary endpoint to the study based on a biomarker in agreement with the FDA. The overall patient population of 330 patients as well as the biomarker-positive subgroup will be separately evaluated during the event-driven interim analysis for futility expected later this year. Depending on the outcome of the interim analysis, the number of patients may increase from 330 to 450. While the interim analysis for futility was planned to take place in Q3, timelines have shifted to Q4 2019, primarily due to a slower than expected income frequency of events.

In addition to the two combination trials in DLBCL, MorphoSys has been evaluating tafasitamab in a phase 2 combination trial in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) since December 2016. The trial, named COSMOS (CLL patients assessed for ORR & Safety in the MOR208 Study), is specifically designed to evaluate the safety of tafasitamab in combination with the cancer drugs idelalisib (cohort A) and venetoclax (cohort B). The study enrolls patients for whom prior therapy with a Bruton’s tyrosine kinase (BTK) inhibitor, such as ibrutinib, has been discontinued. Preliminary data from both cohorts were presented at medical conferences in 2018. The treatment of patients continued during the reporting period, and the intention is to present data at the relevant medical conferences in 2019.

MOR202 is directed against CD38, an antigen that is expressed on the surface of plasma cells. MorphoSys is currently conducting a phase 1/2a study in multiple myeloma (MM). In 2018, the Company announced it will not continue the development of MOR202 for the treatment of MM following the completion of the ongoing trial. This announcement was in line with the Company’s previous announcements that MOR202 will not be developed further for the treatment of MM by MorphoSys without a suitable partner. Irrespective of this, MorphoSys continues to evaluate the potential development of MOR202 in other non-cancer indications, including certain autoimmune diseases, and plans to initiate a clinical phase 1a/2b study in the autoimmune indication anti-PLA2R antibody positive membranous nephropathy (aMN), an inflammatory disease of the kidneys, in the third quarter of 2019.

In November 2017, MorphoSys and I-Mab Biopharma signed a regional license agreement for MOR202 in China, Hong Kong, Taiwan and Macao. MorphoSys will continue to support its partner I-Mab as planned with the further development of MOR202 for the Chinese market. In March 2019, I-Mab reported that the first patient had been treated with MOR202/TJ202 in a phase 2 clinical trial in Taiwan. In this trial, MOR202/TJ202 is being studied in patients with relapsed (recurrent) or refractory (therapy-resistant) bone marrow cancer (multiple myeloma). Following the treatment of the first patients in this study, MorphoSys received a milestone payment of US-$ 5 million. On April 29, 2019, MorphoSys and I-Mab announced the start of a phase 3 clinical study in Taiwan to evaluate MOR202/TJ202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma. The dosing of the first patients triggered a milestone payment of US-$ 3 million to MorphoSys.

 

                

 

 

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MOR106 is a fully human antibody based on MorphoSys’s Ylanthia platform, and the first publicly disclosed antibody directed against IL-17C in clinical development worldwide. MOR106 was jointly discovered by MorphoSys and Galapagos. MorphoSys and Galapagos NV signed an agreement with Novartis Pharma AG on July 19, 2018 to further develop and commercialize MOR106 giving Novartis exclusive worldwide rights to commercialize the products resulting from the agreement. With the signing of the agreement, all future research, development, manufacturing and commercialization costs related to MOR106 are borne by Novartis. The drug candidate is being investigated in a phase 2 study which started in May 2018 named IGUANA in patients with moderately severe to severe atopic dermatitis. A phase 1 bridging study with a subcutaneous formulation of MOR106 was initiated in September 2018. In this double-arm study, MOR106 is first administered subcutaneously or intravenously to healthy volunteers (study part 1). In the second part of the study, patients with moderate to severe atopic dermatitis will be treated with several subcutaneously administered doses of MOR106 for 12 weeks. In accordance with the agreement, MorphoSys and Galapagos continued the ongoing phase 2 IGUANA trial and the phase 1 bridging study during the reporting period. In addition, MorphoSys, Galapagos and Novartis announced on April 23, 2019 the initiation of GECKO, a phase 2 study with MOR106 investigating a subcutaneous formulation of MOR106 in combination with topical corticosteroids. Patient recruiting will take place in the U.S. and Canada, and the study is intended to serve as an Investigational New Drug (IND) opener with the U.S. FDA.

Otilimab (MOR103/GSK3196165) was fully out-licensed to GlaxoSmithKline (GSK) in 2013. GSK investigated this HuCAL antibody in rheumatoid arthritis (RA) and inflammatory hand osteoarthritis, including a phase 2b clinical study in RA and a phase 2a clinical study in patients suffering from inflammatory hand osteoarthritis. GSK announced in the fall of 2018 that it no longer intended to continue the development in hand osteoarthritis. On July 3, 2019, GSK announced the start of a phase 3 program with otilimab in RA which triggered a milestone payment of €22 million to MorphoSys. The phase 3 program, called ContRAst, consists of three pivotal studies and one long-term extension study and will evaluate the antibody in patients with moderate to severe RA.

MorphoSys is also pursuing other programs in addition to those listed above, including several proprietary programs in earlier phases of research and development.

In April, Merck Serono announced that the co-development and licensing agreement with MorphoSys would be terminated in the second quarter of 2019. The collaboration between Merck Serono and MorphoSys included programs in the early stages of drug discovery. The termination of the collaboration has no material impact on MorphoSys.

On June 30, 2019, the number of therapeutic antibody programs within the Proprietary Development segment totaled 12, four of which were out-licensed (December 31, 2018: 12 programs, four of which was out-licensed). Five of these programs are in clinical development, one is in preclinical development, and six are in the discovery stage.

PARTNERED DISCOVERY

The Partnered Discovery segment comprises the activities and programs in which MorphoSys is contracted by its partners to apply its proprietary technology to discover new antibodies. Partners are then responsible for the products’ clinical development and subsequent commercialization with MorphoSys participating in the later development and commercialization success according to predefined milestone payments and royalties.

 

                

 

 

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In mid-April 2019, MorphoSys announced that its licensee Janssen expanded the clinical development of Tremfya® to familial adenomatous polyposis (FAP), a disease of the gastrointestinal tract. MorphoSys received a milestone payment from Janssen in connection with the start of clinical development in the indication FAP. Financial details were not disclosed.

Also in April, MorphoSys announced that its licensee Janssen had issued a press release reporting the topline results of the phase 3 trials called DISCOVER 1 and 2. The studies evaluated the efficacy and safety of guselkumab (Tremfya®) compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). According to Janssen, both studies met their primary endpoints of American College of Rheumatology 20 percent score improvement (ACR20). The safety profiles observed with guselkumab in the DISCOVER program were consistent with previously reported safety profiles in earlier studies of guselkumab and Tremfya® current prescribing information. The DISCOVER program comprises the first-ever phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis. Janssen announced that data will be presented at upcoming scientific medical meetings and that data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.

During the first six months of 2019, the number of therapeutic antibody programs in the Partnered Discovery segment increased to a total of 107 (December 31, 2018: 104). Of these programs, 24 were in clinical development, 25 in preclinical development and 58 in the discovery stage, as of June 30, 2019. In addition our Partnered Discovery programs Tremfya® is on the market.

CORPORATE DEVELOPMENTS

At the Annual General Meeting of MorphoSys AG on May 22, 2019, all resolution proposals of the Company’s management were adopted with the required majority of votes. The Annual General Meeting re-elected Krisja Vermeylen and elected Sharon Curran as a new member of the Company’s Supervisory Board.

In April 2019, the subsidiary MorphoSys US Inc. moved its headquarters from Princeton, New Jersey, to Boston, Massachusetts.

On June 24, 2019, MorphoSys AG announced that the Company’s Supervisory Board appointed Dr. Jean-Paul Kress as the new Chief Executive Officer (CEO) effective September 1, 2019. In his new position, Dr. Kress will succeed Dr. Simon Moroney, who will step down as CEO on September 1, 2019. Dr. Moroney will support Dr. Kress during a transition period.

Intellectual Property

In the first six months of 2019, MorphoSys continued to consolidate and expand the patents protecting its development programs and growing technology portfolio, which represent the Company’s key value drivers.

Currently, the Company possesses more than 60 different proprietary patent families worldwide in addition to the numerous patent families it pursues in cooperation with its partners.

 

                

 

 

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Human Resources

On June 30, 2019, the MorphoSys Group had 373 employees (December 31, 2018: 329). During the first six months of 2019, the number of employees at the MorphoSys Group averaged 353(Q1-Q2  2018: 312).

Financial Analysis

Revenues

Group revenues in the first half of 2019 increased to € 48.2 million (Q1-Q2 2018: € 10.9 million). Revenues in the first half of 2019 comprised the milestone payment from GSK in the amount of € 22.0 million which was triggered by the dosing of the first patient in connection with the start of a clinical phase 3 development program. In accordance with IFRS 15 on revenues from variable consideration, this payment had to be recognized in the second quarter.

Success-based payments including royalties comprised 90%, or € 43.4 million (Q1-Q2 2018: 81% and € 8.8 million), of total revenues. From a geographical standpoint, MorphoSys generated 28%, or € 13.7 million, of its commercial revenues with biotechnology and pharmaceutical companies and non-profit organizations headquartered in North America and 72%, or € 34.5 million, with partners primarily located in Europe and Asia. In the comparable period of the previous year, these figures were 83% and 17%, respectively. Approximately 90% of the Group’s revenues were generated with partners GlaxoSmithKline, Janssen and I-Mab Biopharma (Q1-Q2 2018: 94% with Janssen, Leo Pharma and Pfizer).

PROPRIETARY DEVELOPMENT SEGMENT

In the first half of 2019, the Proprietary Development segment generated revenues of € 31.7 million (Q1-Q2 2018: € 0.3 million). These revenues included milestone payments in the amount of € 29.1 million (Q1-Q2 2018: € 0 million) as well as revenues from service fees in the amount of € 2.6 million (Q1-Q2 2018: € 0.3 million).

PARTNERED DISCOVERY SEGMENT

The revenue of the Partnered Discovery segment contained € 2.2 million of funded research and licensing fees (Q1-Q2 2018: € 1.8 million) and € 14.3 million (Q1-Q2 2018: € 8.8 million) of success-based payments and royalties.

Operating Expenses

COST OF SALES

The cost of sales in the first six months of 2019 amounted to € 9.9 million (Q1-Q2 2018: € 0 million) and included expenses related to services provided for the transfer of projects to customers. Cost of sales also included the manufacturing costs for the fermentation runs of tafasitamab that were required for the approval process in the United States. If successfully approved, the material may be used later for commercialization. According to the Group’s accounting policies, these quantities qualify as inventory. For the time being, this inventory is

 

                

 

 

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valued at a net selling price of nil because tafasitamab has not yet received market approval. The resulting impairment was accounted for in cost of sales.

RESEARCH AND DEVELOPMENT EXPENSES

In the first six months of 2019, research and development expenses amounted to € 49.3 million (Q1- Q2 2018: € 43.0 million). Expenses in this area were largely driven by expenses for external laboratory services in the amount of € 25.0 million (Q1-Q2 2018: € 17.3 million) as well as personnel expenses in the amount of € 13.8 million (Q1-Q2 2018: € 13.1 million). Proprietary development expenses and technology development expenses amounted to € 45.1 million in the first six months of 2019 (Q1-Q2 2018: € 39.2 million).

SELLING EXPENSES

Selling expenses amounted to € 4.9 million in the first six months of 2019 (Q1-Q2 2018: € 2.3 million). This item included mainly personnel expenses in the amount of € 2.3 million (Q1-Q2 2018: € 1.4 million) and expenses for external services of € 2.1 million (Q1-Q2 2018: € 0.5 million).

GENERAL AND ADMINISTRATIVE EXPENSES

In comparison to the same period of the previous year, general and administrative expenses increased to € 13.4 million (Q1-Q2 2018: € 9.3 million). This line item mainly comprised personnel expenses amounting to € 9.7 million (Q1-Q2 2018: € 6.9 million) and expenses for external services of € 2.0 million (Q1-Q2 2018: € 1.3 million).

Financial Position

LIQUIDITY

On June 30, 2019, the Group’s liquidity amounted to € 409.2 million, compared to € 454.7 million on December 31, 2018.

Liquidity as of June 30, 2019 is presented in the balance sheet items “cash and cash equivalents”, “financial assets at fair value, with changes recognized in profit or loss” and “other financial assets at amortized cost”.

The decrease in liquidity resulted from shifts between financial assets and cash and the use of funds for operating activities in the first six months of 2019.

Balance Sheet

ASSETS

As of June 30, 2019, total assets amounted to € 556.8 million and were € 18.0 million above their level on December 31, 2018 (€ 538.8 million). The increase in current assets by € 5.1 million resulted from the increase in accounts receivable and contract assets, cash and cash equivalents as well as financial assets at fair value through profit or loss by a total of € 39.3 million which was largely compensated by a decrease in other financial assets at amortized cost by € 35.2 million.

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                       LOGO   15

 

                

In comparison to December 31, 2018, non-current assets increased by € 12.9 million to a total of € 162.8 million, mainly as a result of the initial recognition of the item “Right-of-Use Assets, net” as part of the application of the new IFRS 16 standard for leases in the amount of € 41.3 million. This effect was mainly offset by a decrease in non-current financial assets by € 26.0 million.

LIABILITIES

Current liabilities increased from € 45.9 million on December 31, 2018 to € 51.7 million on June 30, 2019. This effect mainly resulted from an increase in the line item “Accounts Payable and Accruals” by € 4.0 million and the initial recognition of the item “Current Portion of Lease Liabilities” due to the application of the new IFRS 16 standard in the amount of € 2.0 million.

Non-current liabilities increased by € 37.5 million compared to December 31, 2018. The increase resulted mainly from the initial recognition of the item “Lease Liabilities, Net of Current Portion” due to the application of the new IFRS 16 standard in the amount of € 37.8 million.

STOCKHOLDERS’ EQUITY

On June 30, 2019, Group equity totaled € 463.0 million compared to € 488.4 million on December 31, 2018.

As of June 30, 2019, the number of shares issued totaled 31,839,572, of which 31,584,408 were outstanding (December 31, 2018: 31,839,572 and 31,558,536 shares, respectively.

The value of treasury shares declined from € 10,398,773 on December 31, 2018 to € 9,442,544 on June 30, 2019. The reason for this decline was the transfer of 23,738 treasury shares in the amount of € 877,356 from the performance-based Long-Term Incentive Plan 2015 (LTI plan) to the Management Board and the Senior Management Group. The vesting period for this LTI plan expired on April 1, 2019 and provided beneficiaries a six-month term until October 14, 2019 to receive a total of 52,328 shares. In addition, 2,134 treasury shares valued at € 78,873 were transferred to related parties.

On June 30, 2019, additional paid-in capital amounted to € 622,013,000 (December 31, 2018: € 619,908,453). The increase totaling € 2,104,547 resulted mainly from the allocation of personnel expenses from share-based payments totaling € 3,060,776. This was partly compensated by the decline from the reclassification of treasury shares related to the allocation of shares from the LTI plan 2015 in the amount of € 877,356 and the allocation of treasury shares to related parties in the amount of € 78,873.

Risk and Opportunity Report

The risks and opportunities and their assessment remain unchanged from the situation described on pages 80-88 in the 2018 Annual Report.

 

                

 

 

MorphoSys – II/2019                         


Table of Contents
16    Group Interim Statement                          

 

                

Outlook

FINANCIAL GUIDANCE

Due to the milestone payment for the antibody otilimab by GSK, MorphoSys increased its financial guidance for the 2019 financial year. MorphoSys expects revenues for full-year 2019 in the range of € 65 million to € 72 million (up from previously € 43 million to € 50 million). R&D expenses for proprietary programs and technology development are still expected to reach € 95 million to € 105 million. MorphoSys expects EBIT of € -105 million to € -115 million (up from previously € -127 million to € -137 million). This guidance does not take into account revenues from future collaborations and/or licensing partnerships.

The statements in the 2018 Annual Report on pages 65-68 concerning the strategic outlook, expected business and human resources developments, future research and development and the dividend policy continue to apply.

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                      LOGO   17

 

                

Consolidated Statement of Profit or Loss

(IFRS) – (unaudited)

 

in

 

      

  Note  

 

        

Q2

2019

 

        

Q2

2018

 

        

Q1-Q2
2019

 

        

Q1-Q2
2018

 

 
                                                        
                     

Revenues

       2          34,656,185          8,124,948          48,204,456          10,923,741  

Operating Expenses

       2                                              

Cost of Sales

                  (4,921,410        0          (9,891,210        0  

Research and Development

                  (24,652,089        (25,813,012        (49,344,574        (42,981,245

Selling

                  (3,225,981        (1,452,098        (4,900,824        (2,292,594

General and Administrative

                  (7,458,856        (5,470,520        (13,377,392        (9,348,874

Total Operating Expenses

                  (40,258,336        (32,735,630        (77,514,000        (54,622,713

Other Income

                  165,897          528,816          320,310          815,305  

Other Expenses

                  (295,790        (64,327        (330,527        (285,260

Earnings before Interest and Taxes (EBIT)

                  (5,732,044        (24,146,193        (29,319,761        (43,168,927

Finance Income

       3          113,260          195,911          1,055,110          217,136  

Finance Expenses

       3          (440,492        (246,633        (690,113        (522,893

Income from Reversals of Impairment Losses /

(Impairment Losses) on Financial Assets

                  291,000          (639,000        859,000          (727,000

Income Tax Benefit / (Expenses)

                  (91,028        1,296,902          (433,031        1,174,660  

Consolidated Net Loss

                  (5,859,304        (23,539,013        (28,528,795        (43,027,024

Earnings per Share, basic and diluted

                  (0.19        (0.76        (0.90        (1.38

Shares Used in Computing Earnings per Share, basic

and diluted

                  31,576,812          31,095,634          31,567,074          31,134,361  

 

                

 

 

MorphoSys – II/2019                           


Table of Contents
18    Group Interim Statement                            

 

                

Consolidated Statement of Comprehensive Income (IFRS) – (unaudited)

 

  in

 

      

Q2
2019

 

        

Q2
2018

 

        

Q1-Q2
2019

 

        

Q1-Q2
2018

 

 
                   
         

Consolidated Net Loss

       (5,859,304        (23,539,013        (28,528,795        (43,027,024

Change in Fair Value of Equity Instruments through Other

Comprehensive Income 1

       106,000          0          106,000          0  

Foreign Currency Translation Differences from Consolidation 2

       45,835          0          31,574          0  

Other Comprehensive Income

       151,835          0          137,574          0  

Total Comprehensive Income

       (5,707,469        (23,539,013        (28,391,221        (43,027,024

1 Item will not be reclassified in terms of IAS 1.82A(a)(i) to profit or loss in subsequent periods.

2 Item will be reclassified in terms of IAS 1.82A(a)(ii) to profit or loss in subsequent periods when specific conditions are met.

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                        LOGO   19

 

                

Consolidated Balance Sheet (IFRS)

 

  in

 

      

Note

 

        

June 30, 2019
(unaudited)

 

        

Dec. 31, 2018
(audited)

 

 
              
       

ASSETS

                                

Current Assets

                                

Cash and Cash Equivalents

       4          54,704,659          45,459,836  

Financial Assets at Fair Value through Profit or Loss

       4          50,946,333          44,581,264  

Other Financial Assets at Amortized Cost

       4          233,769,000          268,922,724  

Accounts Receivable and Contract Assets

       4          41,436,777          17,732,933  

Income Tax Receivables

                  98,873          161,048  

Other Receivables

       3, 4          1,722,028          147,449  

Inventories, Net

                  316,661          245,161  

Prepaid Expenses and Other Current Assets

                  10,998,433          11,654,880  

Total Current Assets

                  393,992,764          388,905,295  

Non-current Assets

                                

Property, Plant and Equipment, Net

                  3,689,029          3,530,709  

Right-of-Use Assets, net

       1          41,343,317          0  

Patents, Net

                  3,452,118          3,938,739  

Licenses, Net

                  2,487,467          2,526,829  

In-process R&D Programs

                  37,019,370          37,019,370  

Software, Net

                  169,536          203,807  

Goodwill

                  3,676,233          3,676,233  

Other Financial Assets at Amortized Cost, Net of Current Portion

       4          69,732,189          95,749,059  

Shares at Fair Value through Other Comprehensive Income

                  338,000          232,000  

Prepaid Expenses and Other Assets, Net of Current Portion

                  890,982          2,981,716  

Total Non-current Assets

                  162,798,241          149,858,462  

Total Assets

                  556,791,005          538,763,757  

 

                

 

 

MorphoSys – II/2019                            


Table of Contents
20    Group Interim Statement                          

 

                

 

  in

 

      

Note

 

        

June 30, 2019
(unaudited)

 

        

Dec. 31, 2018
(audited)

 

 
              
             

LIABILITIES AND STOCKHOLDERS’ EQUITY

                                

Current Liabilities

                                

Accounts Payable and Accruals

       4          48,800,864          44,760,615  

Current Portion of Lease Liabilities

       1          2,040,435          0  

Tax Provisions

                  208,034          208,034  

Other Provisions

                  69,603          160,411  

Current Portion of Contract Liability

                  549,136          794,230  

Convertible Bonds due to Related Parties

       4          71,517          0  

Total Current Liabilities

                  51,739,589          45,923,290  

Non-current Liabilities

                                

Lease Liabilities, Net of Current Portion

       1          37,765,199          0  

Other Provisions, Net of Current Portion

                  23,166          23,166  

Contract Liability, Net of Current Portion

                  281,637          158,024  

Convertible Bonds due to Related Parties

       4          0          71,517  

Deferred Tax Liability

                  3,939,225          3,507,233  

Other Liabilities, Net of Current Portion

                  0          707,893  

Total Non-current Liabilities

                  42,009,227          4,467,833  

Total Liabilities

                  93,748,816          50,391,123  
                                  

Stockholders’ Equity

                                

Common Stock

            31,839,572          31,839,572  

 

Ordinary Shares Issued (31,839,572 and 31,839,572 for 2019 and 2018,

respectively)

                                

Ordinary Shares Outstanding (31,584,408 and 31,558,536 for 2019 and 2018,

respectively)

                                

Treasury Stock (255,164 and 281,036 shares for 2019 and 2018, respectively),

at Cost

                  (9,442,544        (10,398,773

Additional Paid-in Capital

                  622,013,000          619,908,453  

Other Comprehensive Income Reserve

                  (73,316        (210,890

Accumulated Deficit

                  (181,294,523        (152,765,728

Total Stockholders’ Equity

                  463,042,189          488,372,634  

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

                  556,791,005          538,763,757  

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                      LOGO   21

 

                

Consolidated Statement of Changes in Stockholders’ Equity (IFRS) – (unaudited)

 

                        Common Stock                      
         

Note

 

        

                    Shares

 

        

 

             
                                             

Balance as of December 31, 2017

                  29,420,785          29,420,785                                

Application of IFRS 9

                  0          0             

Application of IFRS 15

                  0          0             

Balance as of January 1, 2018

                  29,420,785          29,420,785             

Capital Increase, Net of Issuance Cost of € 15,037,622

                  2,386,250          2,386,250             

Compensation Related to the Grant of Stock Options, Convertible

Bonds and Performance Shares

                  0          0             

Exercise of Convertible Bonds Issued to Related Parties

                  1,000          1,000             

Transfer of Treasury Stock for Long-Term Incentive Program

                  0          0             

Transfer of Treasury Stock to Members of the Management Board

                  0          0             

Reserves:

                                           

Consolidated Net Loss

                  0          0             

Total Comprehensive Income

                  0          0             

Balance as of June 30, 2018

                  31,808,035          31,808,035             

Balance as of January 1, 2019

                  31,839,572          31,839,572             

Compensation Related to the Grant of Stock Options and Performance Shares

       6, 9          0          0             

Transfer of Treasury Stock for Long-Term Incentive Program

       5, 6          0          0             

Transfer of Treasury Stock to Related Parties

       5, 6          0          0             

Reserves:

                                           

Change in Fair Value of Equity Instruments through Other

Comprehensive Income

                  0          0             

Foreign Currency Losses from Consolidation

                  0          0             

Consolidated Net Loss

                  0          0             

Total Comprehensive Income

                  0          0             

Balance as of June 30, 2019

                  31,839,572          31,839,572             

 

                

 

 

MorphoSys – II/2019                          


Table of Contents
22    Group Interim Statement                            

 

    

        Treasury Stock         Additional Paid-in
Capital
        Revaluation
Reserve
        Other
Comprehensive
Income Reserve
        Accumulated
Deficit
       

Total
Stockholders’

Equity

 
        

Shares

 

       

 

       

 

       

 

       

 

       

 

       

 

 
                                                                 

                                 

      319,678         (11,826,981       438,557,856         (105,483       0         (97,375,138       358,671,039  
        0         0         0         105,483         0         (353,483       (248,000
        0         0         0         0         0         1,135,014         1,135,014  
        319,678         (11,826,981       438,557,856         0         0         (96,593,607       359,558,053  
        0         0         176,189,996         0         0         0         178,576,246  
        0         0         3,768,628         0         0         0         3,768,628  
        0         0         30,875         0         0         0         31,875  
        (8,639       319,297         (319,297       0         0         0         0  
        (1,199       44,315         (44,315       0         0         0         0  
        0         0         0         0         0         (43,027,024       (43,027,024
        0         0         0         0         0         (43,027,024       (43,027,024
        309,840         (11,463,369       618,183,743         0         0         (139,620,631       498,907,778  
        281,036         (10,398,773       619,908,453         0         (210,890       (152,765,728       488,372,634  
        0         0         3,060,776         0         0         0         3,060,776  
        (23,738       877,356         (877,356       0         0         0         0  
        (2,134       78,873         (78,873       0         0         0         0  
        0         0         0         0         106,000         0         106,000  
        0         0         0         0         31,574         0         31,574  
        0         0         0         0         0         (28,528,795       (28,528,795
        0         0         0         0         137,574         (28,528,795       (28,391,221
        255,164         (9,442,544       622,013,000         0         (73,316       (181,294,523       463,042,189  
 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   23

 

                

Consolidated Statement of Cash Flows(IFRS) – (unaudited)

 

Q1-Q2 (in )

 

      

Note

 

        

2019

 

        

2018

 

 
                                      

Operating Activities:

                                

Consolidated Net Loss

                  (28,528,795        (43,027,024

Adjustments to Reconcile Net Loss to Net Cash Provided by / (Used in)

Operating Activities:

                                

Impairment of Assets

                  0          4,805,466  

Depreciation and Amortization of Tangible and Intangible Assets and of

Right-of-Use Assets

                  3,061,535          1,993,969  

Net (Gain) / Loss on Sales of Financial Assets at Fair Value through Profit or

Loss

                  (427,522        25,237  

(Income) from Reversals of Impairment Losses / Impairment Losses on

Financial Assets

                  (859,000        727,000  

Proceeds from Derivative Financial Instruments

                  294,887          (545,632

Net (Gain) / Loss on Derivative Financial Instruments

                  (440,866        206,522  

Net (Gain) / Loss on Sale of Property, Plant and Equipment

                  961          (22,298

Recognition of Contract Liability

                  (2,234,458        (500,084

Share-based Payment

       9          3,060,776          3,768,628  

Income Tax (Benefit) / Expenses

                  433,031          (1,174,660

Changes in Operating Assets and Liabilities:

                                

Accounts Receivable and Contract Assets

                  (23,688,844        (613,775

Prepaid Expenses and Other Assets, Tax Receivables and Other Receivables

                  (1,252,323        476,691  

Accounts Payable and Accruals, Lease Liabilities, Tax Provisions and Other

Provisions

                  4,280,321          (4,078,193

Other Liabilities

                  230,098          (1,223,550

Contract Liability

                  2,112,976          549,107  

Income Taxes Paid

                  (13,712        (13,119

Net Cash Provided by / (Used in) Operating Activities

                  (43,970,935        (38,645,715

 

                

 

 

MorphoSys – II/2019                          


Table of Contents
24    Group Interim Statement                            

 

                

 

Q1-Q2 (in )

 

      

  Note  

 

        

2019

 

        

2018

 

 
                                    
             

Investing Activities:

                                

Purchase of Financial Assets at Fair Value through Profit or Loss

                  (13,326,710        (74,870,125

Proceeds from Sales of Financial Assets at Fair Value through Profit or Loss

                  7,356,761          62,500,000  

Purchase of Other Financial Assets at Amortized Cost

                  (41,000,000        (192,910,000

Proceeds from Sales of Other Financial Assets at Amortized Cost

                  103,000,000          44,999,796  

Purchase of Property, Plant and Equipment

                  (1,123,055        (597,838

Proceeds from Disposals of Property, Plant and Equipment

                  0          23,445  

Purchase of Intangible Assets

                  (211,988        (205,951

Interest Received

                  50,517          49,945  

Net Cash Provided by / (Used in) Investing Activities

                  54,745,525          (161,010,728
                                  

Financing Activities:

                                

Proceeds of Share Issuance

                  0          193,613,868  

Cost of Share Issuance

                  0          (15,037,622

Proceeds in Connection with Convertible Bonds Granted to Related Parties

       5, 6          0          31,375  

Principal Elements of Lease Payments

                  (1,140,958        0  

Interest Paid

                  (459,296        (2,020

Net Cash Provided by / (Used in) Financing Activities

                  (1,600,254        178,605,601  

Effect of Exchange Rate Differences on Cash

                  70,487          0  

Increase / (Decrease) in Cash and Cash Equivalents

                  9,244,823          (21,050,842

Cash and Cash Equivalents at the Beginning of the Period

                  45,459,836          76,589,129  

Cash and Cash Equivalents at the End of the Period

                  54,704,659          55,538,287  

 

                

 

 

                       MorphoSys – II/2019


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Group Interim Statement                          LOGO   25

 

                

Notes (Unaudited)

MorphoSys AG (“the Company” or “MorphoSys”) develops and applies technologies for generating therapeutic antibodies. MorphoSys possesses a broad portfolio of proprietary compounds and an extensive pipeline of compounds jointly developed with partners from the pharmaceutical and biotechnology industry. MorphoSys was founded in July 1992 as a German limited liability company and became a German stock corporation in June 1998. In March 1999, the Company completed its initial public offering on Germany’s “Neuer Markt,” the former segment of the Deutsche Börse designated for high-growth companies. On January 15, 2003, MorphoSys AG was admitted to the Prime Standard segment of the Frankfurt Stock Exchange. On April 18, 2018, the Company completed its initial public listing on the Nasdaq Global Market with the placement of American Depositary Shares (ADS). Each ADS represents 1/4 of a MorphoSys ordinary share. MorphoSys AG’s registered head office is located in Planegg (district of Munich), and the registered business address is Semmelweisstraße 7, 82152 Planegg, Germany. The Company is registered in the Commercial Register of the District Court of Munich, Section B, under HRB 121023.

These interim consolidated financial statements were prepared in accordance with the International Financial Reporting Standards (IFRS) of the International Accounting Standards Board (IASB) taking into account the recommendations of the International Financial Reporting Standards Interpretations Committee (IFRS IC) as applicable in the European Union (EU). These interim consolidated financial statements comply with IAS 34 “Interim Financial Reporting.”

The condensed interim consolidated financial statements do not contain all of the information and disclosures required for the financial year-end consolidated financial statements and, therefore, should be read in conjunction with the consolidated financial statements dated December 31, 2018.

The condensed interim consolidated financial statements were approved for publication on July 23, 2019.

The consolidated financial statements as of June 30, 2019, include MorphoSys AG, MorphoSys US Inc. (Boston, Massachusetts, USA), Lanthio Pharma B.V. (Groningen, the Netherlands) and LanthioPep B.V. (Groningen, the Netherlands), which are collectively known as the “Group”. MorphoSys US Inc. was included in the group of consolidated companies since July 2, 2018.

On January 31, 2019, MorphoSys disclosed that in its lawsuit against Janssen Biotech and Genmab A/S, the parties settled the dispute. As a result of this, the parties to the dispute agreed to drop the mutual claims related to this litigation. MorphoSys dismissed its claims and did not appeal from the previously-announced court order dated January 25, 2019. Janssen and Genmab dismissed their counterclaims.

 

  LOGO

Accounting Policies

Aside from the accounting and valuation principles and the principles included in the new and amended standards described below, the accounting and valuation principles applied to the consolidated financial statements for the financial year ending December 31, 2018, were the same

 

                

 

 

MorphoSys – II/2019                          


Table of Contents
26    Group Interim Statement                      

 

applied to the first six months of 2019. The consolidated financial statements for the financial year ending December 31, 2018 can be found on the Company’s website under www.morphosys.com/financial-reports.

INVENTORY

In addition to raw materials and supplies, inventory as of June 30, 2019, also comprised manufacturing costs for the fermentation runs of antibody material (tafasitamab) that is required for the approval process in the United States. If successfully approved, the material may be used later for commercialization. Commercialization is regarded as a sale in the ordinary course of business in accordance with IAS 2, hence the material is accounted for as inventory. According to the Group’s accounting policies, these quantities qualify as inventory. For the time being, this inventory is valued at a net selling price of nil because tafasitamab has not yet received market approval. The resulting impairment in the amount of € 8.3 million was accounted for in cost of sales.

NEW AND REVISED STANDARDS AND INTERPRETATIONS APPLIED FOR THE FIRST TIME IN THE FINANCIAL YEAR

 

Standard/Interpretation

 

      

Mandatory 
Application for 
financial years 
starting on 

 

        

Adopted by the 
European Union 

 

        

Impact on 
MorphoSys 

 

 
                                         

IFRS 16

     Leases        01/01/2019           yes           yes   

IFRS 9 (A)

     Prepayment Features with Negative Compensation        01/01/2019           yes           none   

IAS 19 (A)

     Plan Amendment, Curtailment or Settlement        01/01/2019           yes           none   

IAS 28 (A)

     Long-Term Interests in Associates and Joint Ventures        01/01/2019           yes           none   

IFRIC 23

     Uncertainty over Income Tax Treatments        01/01/2019           yes           none   
                                         
       Annual Improvements to IFRS Standards 2015 - 2017        01/01/2019           yes           none   
                                         

(A) Amendments

                                               

IFRS 16 – LEASES

The Group has applied the new IFRS 16 standard for leases since January 1, 2019. In the 2018 financial year, the Group had accounted for leases according to the IAS 17 standard, including the related interpretations (IFRIC 4, SIC-15, SIC-27). The lease agreements accounted for as operating leases in accordance with IAS 17 until December 31, 2018, were recognized as lease liabilities in the Group with the first-time application of IFRS 16. In accordance with IAS 17, payments made under operating leases, less lease incentives, were recognized in profit or loss on a straight-line basis over the term of the lease.

The Group applied IFRS 16 for the first time as of January 1, 2019, using the modified retrospective method. Comparative amounts for the 2018 financial year were not retroactively adjusted. On January 1, 2019, the Group recognized right-of-use assets in the amount of the lease liabilities in accordance with IFRS 16.C8 (b)(ii). Practical expedients in accordance with IFRS 16.C10 for leases previously classified as operating leases in accordance with IAS 17 were not applied. Leases entered into before the date of initial application were not reassessed as to whether a contract is, or contains,

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   27

 

                

a lease at the date of first-time application, but the assessment previously made under IAS 17 was retained.

At inception of a contract, the Group assesses as to whether the contract is, or contains, a lease. The following lease categories have been identified, for which the transition to IFRS 16 on January 1, 2019 resulted in the accounting for leases under the new standard of lease contracts previously recognized as operating leases: buildings, vehicles and technical equipment. For contracts concluded after January 1, 2019, the assessment as to whether a contract is, or contains, a lease is done on the basis of IFRS 16. This is the case within the meaning of IFRS 16 if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration.

Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. Lease contracts are typically negotiated for fixed periods, but may include extension options. These terms offer the Group the greatest possible operational flexibility. For determining the lease terms all facts and circumstances are included which offer an economic incentive to exercise extension options. Extension options are only included in the lease term if the lease is reasonably certain to be extended. The leases include fixed and variable lease payments that depend on an index.

The lease liability as of January 1, 2019 was measured at present value. To determine the present value, the remaining lease payments were discounted to January 1, 2019 using the lessee’s incremental borrowing rate. The weighted average interest rate amounted to 2.17% and is mainly based on hypothetically granted bank loans for an asset with a similar value and term as the right-of-use asset.

Based on the operating lease liabilities as of December 31, 2018, the following table shows the reconciliation to the lease liabilities’ carrying amount in the opening balance sheet as of January 1, 2019.

 

in 000’        Lease Liabilities  
            
   

Operating Lease Commitments disclosed as of December 31, 2018

       22,530  

Commitments for Not Identifiable Assets

       (90

Leases of Low Value Assets, Expensed on a Straight-Line Basis

       (56

Other

       28  

Lease Liabilities, undiscounted, as of January 1, 2019

       22,412  

Adjustments as a Result of Different Assessment of Extension Options

       26,855  

Gross Lease Liabilities as of January 1, 2019

       49,267  

Discounting

       (8,484

Lease Liabilities as of January 1, 2019

       40,783  

thereof short-term

       2,026  

thereof long-term

       38,757  

For one building, extension options (two times five years after a minimum lease term of ten years) were included in the determination of the lease liability as of January 1, 2019 as it is reasonably certain that these options will be exercised. This assessment is based on the fact that extensive alterations were made to this building to meet the Group’s requirements. Alternatives to the existing building are therefore only available to a very limited extent.

 

                

 

 

MorphoSys – II/2019                          


Table of Contents
28    Group Interim Statement                          

 

                

The first-time application of IFRS 16 as of January 1, 2019 resulted in the recognition of right-of-use assets and lease liabilities of € 40.8 million in the balance sheet. In addition, current prepaid expenses of € 0.4 million resulting from rent paid in advance and non-current prepaid expenses of € 2.1 million were reclassified to the capitalized right-of-use asset as of January 1, 2019. Furthermore, as of January 1, 2019, current other liabilities of € 0.1 million and non-current other liabilities of € 0.7 million resulting from deferred rent-free periods were offset against the right-of-use asset. As a result of these reclassifications as of January 1, 2019, right-of-use assets (€ 42.5 million) and lease liabilities (€ 40.8 million) resulted in different amounts. This resulted in deferred tax liabilities of € 0.2 million.

IFRS 16 has a material impact on components of the consolidated financial statements and the presentation of net assets, financial position and results of operations. The resulting expansion in total liabilities has led to a decline in the equity ratio. The first-time adoption of IFRS 16 did not have an impact on equity as of January 1, 2019 and did not have a material impact on Group EBIT.

For lessees, IFRS 16 introduces a uniform approach to the accounting treatment of leases, whereby assets for the right of use and liabilities for the payment obligations must be recognized in the balance sheet for all leases. The right of use and the corresponding lease liability are to be recognized as of the date on which the Group can use the lease asset.

Right-of-use assets are measured at cost, which comprises the lease liability, lease payments made at or before the commencement date, less any lease incentives received, initial direct costs and asset removal obligations. The right-of-use assets are subsequently measured at amortized cost. The right-of-use assets are amortized on a straight-line basis to the earlier of the useful life or the lease term.

The lease liability is the present value of the fixed and variable lease payments that are paid during the term of the lease less any lease incentives receivable. The discounting is carried out based on the implied interest rate underlying the lease contract if the rate can be determined. If not, discounting is carried out based on the lessee’s incremental borrowing rate, i.e., the interest rate a lessee would need to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of similar value and condition to the right-of-use asset in a similar economic environment.

For subsequent measurement, the carrying amount of the lease liabilities is increased to reflect interest on the lease liability and reduce to reflect the lease payments made. Each lease installment is divided into repayment and financing expenses. The financing expenses are recognized in profit or loss over the term of the lease.

The lease expenses recognized in the statement of income prior to and including the 2018 financial year have been replaced by depreciation on assets and interest expenses from the compounding of lease liabilities since January 1, 2019. This change means that the related costs are presented in different line items in the statement of income and differ in their total amount compared to the application of IAS 17. Due to the interest expenses reported under financial expenses in the statement of profit or loss, there is a material effect on Group EBIT in the financial year compared with the application of IAS 17. In accordance with IAS 17, interest expenses were a component of lease expenses and were reported under operating expenses in the income statement.

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   29

 

                

Payments for the repayment of lease liabilities and payments relating to the interest portion of the lease liability have been allocated to cash flow from financing activities.

For low value lease assets or short-term leases (terms of less than twelve months), mainly technical equipment, the simplification options contained in IFRS 16 have been applied. Accordingly, no right-of-use assets and lease liabilities are recognized in the balance sheet, but lease payments are recognized as expenses over the term of the lease.

The right-of-use assets and lease liabilities developed as follows in the first six months of 2019.

 

         

Right-of-Use Assets

 

       

Lease Liabilities

 

 
in 000’

 

      

     Building

 

        

        Cars

 

        

Technical
Equipment

 

        

        Total

 

            
                                                             
           

Balance as of January 1, 2019

       42,094          244          168          42,506         40,783  

Additions

       0          35          128          163         163  

Depreciation of Right-of-Use Assets

       (1,189        (73        (64        (1,326       0  

Interest Expenses on Lease Liabilities

       0          0          0          0         438  

Lease Payments

       0          0          0          0         (1,579

Balance as of June 30, 2019

       40,906          206          232          41,343         39,805  

IFRS 16 had the following effect on the statement of profit or loss in the first six months of 2019.

 

Q1-Q2 (in 000’ )

 

      

2019

 

 
              
   

Depreciation of Right-of-Use Assets

       (1,326

Interest Expenses on Lease Liabilities

       (438

Expenses for Short Term Leases

       (17

Expenses for Leases of Low Value Assets

       0  

Total

       (1,781

The following table shows the maturity analysis of lease liabilities as of June 30, 2019.

 

June 30, 2019
(in 000’ )
Contractual Maturities of
Financial Liabilities

 

      

Up to One Year

 

        

Between One
and Five Years

 

        

More than Five
Years

 

        

Total Contractual
Cash Flows

 

        

Carrying Amount
Liabilities

 

 
                                                              
           

Lease Liabilities

       2,892          10,944          34,016          47,852          39,805  

 

                

 

 

MorphoSys – II/2019                          


Table of Contents
30    Group Interim Statement                            

 

                

The Group has entered into a lease for a building in Boston that commences on October 1, 2019. The minimum lease term of seven years results in a contractually agreed cash outflow of US-$ 5.0 million. The contract contains an extension option for five years.

NEW AND REVISED STANDARDS AND INTERPRETATIONS THAT WERE NOT YET MANDATORY

The following new and revised standards and interpretations, which were not yet mandatory for the reporting period or were not yet adopted by the European Union were not applied in advance. Standards with the remark “yes” are likely to have an impact on the consolidated financial statements and are currently being assessed by the Group. The following discussion focuses only on those changes that have a material impact. The impact on the consolidated financial statements from the amendments to IAS 1 and IAS 8 is not considered to be material and is therefore not explained separately. Standards with the remark “none” are not expected to have a material impact on the consolidated financial statements.

 

 Standard/Interpretation

 

      

Mandatory
Application for
financial years
starting on

 

        

Adopted by the
European Union

 

        

Possible Impact
on MorphoSys

 

 
                                        

IFRS 3 (A)

    Business Combinations        01/01/2020          no          none  

IFRS 17

    Insurance Contracts        01/01/2021          no          none  

IAS 1 und IAS 8 (A)

    Definition of Material        01/01/2020          no          yes  
                                        
     

Amendments to References

to the Conceptual

Framework in IFRS

Standards

       01/01/2020          no          none  
                                        

(A) Amendments

                                      

 

  LOGO

Segment Reporting

When conducting segment reporting, the Group applies IFRS 8 “Segment Reporting”. An operating segment is defined as a component of an entity that engages in business activities from which it may earn revenues and incur expenses and whose operating results are regularly reviewed by the entity’s chief operating decision maker, the Management Board, and for which discrete financial information is available.

Segment information is provided for the Group’s operating segments based on the Group’s management and internal reporting structures. Segment results and segment assets include items that can be either directly attributed to the individual segment or allocated to the segment on a reasonable basis.

The Management Board evaluates a segment’s economic success using selected key figures so that all relevant income and expenses are included. EBIT, which the Company defines as earnings before finance income, finance expenses, impairment losses on financial assets and income taxes, is the key benchmark for measuring and evaluating the operating results. Other key internal reporting figures include revenues, operating expenses, segment results and the liquidity position.

 

                

 

 

                       MorphoSys – II/2019


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Group Interim Statement                              LOGO   31

 

The Group consists of the operating segments described below.

PROPRIETARY DEVELOPMENT

The segment comprises all activities related to the proprietary development of therapeutic antibodies and peptides. Currently, this segment’s activities comprise a total of twelve antibody and peptide programs, with tafasitamab (MOR208) representing the Company’s most advanced proprietary clinical program. Also included are the antibody MOR202, which was partially out-licensed to I-Mab Biopharma; MOR106, which had been co-developed with Galapagos and out-licensed to Novartis during the reporting year; and the Company’s MOR103 program, which was out-licensed to GlaxoSmithKline (GSK) in 2013. The partially or completely out-licensed programs have been part of the Proprietary Development segment since the beginning of their development and will therefore continue to be reported in this segment. MorphoSys is also pursuing other early-stage proprietary development and co-development programs. These include the clinical program MOR107 (formerly LP2), which originated from the acquisition of Lanthio Pharma B.V. This program was evaluated in a phase 1 study in healthy volunteers and is currently undergoing preclinical studies for oncology indications. One other program is in preclinical development, and six other programs are in drug discovery. The Proprietary Development segment also manages the development of proprietary technologies.

PARTNERED DISCOVERY

MorphoSys possesses one of the leading technologies for generating therapeutics based on human antibodies. The Group markets this technology commercially through its partnerships with numerous pharmaceutical and biotechnology companies. The Partnered Discovery segment encompasses all operating activities relating to these commercial agreements.

 

Q1-Q2

 

      

Proprietary Development

 

        

Partnered Discovery

 

        

Unallocated

 

        

Group

 

 
(in 000’ )

 

      

2019

 

        

2018

 

        

2019

 

        

2018

 

        

2019

 

        

2018

 

        

2019

 

        

2018

 

 
                                                                                                  
                                 

External Revenues

       31,665          259          16,539          10,665          0          0          48,204          10,924  

Operating Expenses

       (63,698        (40,772        (4,791        (4,545        (9,025        (9,306        (77,514        (54,623

Segment Result

       (32,033        (40,513        11,748          6,120          (9,025        (9,306        (29,310        (43,699

Other Income

       46          96          0          0          274          719          320          815  

Other Expenses

       0          0          0          0          (331        (285        (331        (285

Segment EBIT

       (31,987        (40,417        11,748          6,120          (9,082        (8,872        (29,321        (43,169

Finance Income

                                                                         1,055          217  

Finance Expenses

                                                                         (690        (523

Income from Reversals of

Impairment Losses / (Impairment

Losses) on Financial Assets

                                                                         859          (727

Earnings before Taxes

                                                                         (28,097        (44,202

Income Tax Expenses

                                                                         (433        1,175  

Net Loss

                                                                         (28,530        (43,027

 

MorphoSys – II/2019                          


Table of Contents
32    Group Interim Statement                            

 

Q2

 

      

Proprietary Development

 

        

Partnered Discovery

 

        

Unallocated

 

        

Group

 

 
(in 000’ )

 

      

2019

 

        

2018

 

        

2019

 

        

2018

 

        

2019

 

        

2018

 

        

2019

 

        

2018

 

 
                                                                                                  
                                 

External Revenues

       25,909          65          8,747          8,060          0          0          34,656          8,125  

Operating Expenses

       (32,933        (24,690        (2,480        (2,578        (4845        (5,468        (40,258        (32,736

Segment Result

       (7,024        (24,625        6,267          5,482          (4845        (5,468        (5,602        (24,611

Other Income

       (5        68          0          0          171          461          166          529  

Other Expenses

       0          0          0          0          (296        (64        (296        (64

Segment EBIT

       (7,029        (24,557        6,267          5,482          (4,970        (5,071        (5,732        (24,146

Finance Income

                                                                         113          196  

Finance Expenses

                                                                         (440        (247

Impairment Losses on Financial

Assets

                                                                         291          (639

Earnings before Taxes

                                                                         (5,768        (24,836

Income Tax Benefit /

(Expenses)

                                                                         (91        1,297  

Net Profit / (Loss)

                                                                         (5,860        (23,539

* Differences due to rounding.

The table below provides an overview of the geographic distribution of Group revenues based on the location of the partner.

 

Q1-Q2 (in 000’ )

 

      

 

        2019

 

 

 

      

 

        2018

 

 

 

                       
Germany        145          259  
Europe and Asia        34,378          1,662  
USA and Canada        13,681          9,003  
Total        48,204          10,924  

Group revenues included € 29.7 million (Q1-Q2 2018: € 3.4 million) of success-based payments and € 13.7 million (Q1-Q2 2018: € 5.4 million) of royalties. The overview below shows the schedule for meeting performance obligations.

 

Q1-Q2

 

      

Proprietary Development

 

        

Partnered Discovery

 

 
(in 000’ )

 

      

2019

 

        

2018

 

        

2019

 

        

2018

 

 
                                             

At a Point in Time

thereof performance obligations fulfilled in previous periods:

in Proprietary Development € 29.1 million in 2019 and € 0 in

2018 and

in Partnered Discovery € 13.7 million in 2019 and € 8.6 million in

2018

       31,665          259          16,271          10,336  

Over Time

       0          0          268          329  

Total

       31,665          259          16,539          10,665  

Accounts receivable and contract assets included accounts receivable in the amount of € 19.4 million (December 31, 2018: € 17.7 million) and contract assets in the amount of € 22.0 million (December 31, 2018: € 0). The contract assets resulted from GSK’s milestone payment for the antibody otilimab.

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   33

 

                

 

  LOGO

Financial Instruments

MorphoSys regularly employs forward rate contracts to hedge its foreign exchange risk. As of June 30, 2019, there were 5 unsettled forward rate agreements (December 31, 2018: 9) with remaining maturities of one to seven months. The gross unrealized gain of € 0.2 million (December 31, 2018: gross unrealized gain of € 0.1 million) was recorded in the financial result.

 

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Fair Value Measurement

MorphoSys uses the following hierarchy for determining and disclosing the fair value of financial instruments.

 

Level 1:  

Quoted (unadjusted) prices in active markets for identical assets or liabilities to which the Company has access.

Level 2:  

Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (derived from prices).

Level 3:  

Inputs for the asset or liability that are not based on observable market data (i.e., unobservable inputs).

The carrying amounts of financial assets and liabilities, such as other financial assets at amortized cost, as well as accounts payable and receivable, approximate their fair values due to their short-term maturities.

Hierarchy Level 2 contains forward exchange contracts to hedge exchange rate fluctuations, term deposits and restricted cash. Future cash flows for these forward exchange contracts are determined based on forward exchange rate curves. The fair value of these instruments corresponds to their discounted cash flows. The fair value of the term deposits and restricted cash is determined by discounting the expected cash flows at market interest rates.

Financial assets belonging to Hierarchy Level 3 include investments at fair value, with changes recognized in other comprehensive income. No financial liabilities were assigned to Hierarchy Level 3.

There were no transfers from one fair value hierarchy level to another in the years 2019 and 2018.

The fair values of financial assets and liabilities and the carrying amounts presented in the consolidated balance sheet consist of the following items:

 

                

 

 

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34    Group Interim Statement                            

 

                

 

 June 30, 2019
 (in 000’ )
      Hierarchy
Level
        Not classified
into a
Measurement
Category
        Financial Assets at
Amortized Cost
       

Financial Assets

at Fair Value

(Through Profit

or Loss)

            
                                                   
           

Cash and Cash Equivalents

      *                   54,705         0                               

Financial Assets at Fair Value through Profit or Loss

      1                   0         50,946            

Other Financial Assets at Amortized Cost

      *                   233,769         0            

Accounts Receivable and Contract Assets

      *                   41,437         0            

Other Receivables

                                                 

thereof Financial Assets

      *                   1,510                      

thereof Forward Exchange Contracts used for Hedging

      2                   0         212            

Current Assets

                          331,421         51,158            

Other Financial Assets at Amortized Cost, Net of Current Portion

      2                   69,732         0            

Shares at Fair Value through Other Comprehensive Income

      3                   0         0            

Prepaid Expenses and Other Assets, Net of Current Portion

                                                 

thereof Non-Financial Assets

      n/a         165                                

thereof Restricted Cash

      2                   726         0            

Non-current Assets

                165         70,458         0            

Total

                165         401,879         51,158            

Accounts Payable and Accruals

      *                   0         0            

Convertible Bonds - Liability Component

      2                   0         0            

Current Liabilities

                          0         0            

Total

                          0         0            

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   35

 

          Financial Assets at
Fair Value (Through
Other
Comprehensive
Income)
         Financial Liabilities at
Amortized Cost
         Financial Liabilities at
Fair Value
         Total Carrying
Amount
         Fair value  
                                                                
         0          0          0          54,705          *  
           
         0          0          0          50,946          50,946  
           
         0          0          0          233,769          *  
           
         0          0          0          41,437          *  
                                          1,722             
                                          1,510          *  
           
         0          0          0          212          212  
         0          0          0          382,579             
           
         0          0          0          69,732          69,732  
           
         338          0          0          338          338  
           
                                          891             
                                          165          n/a  
         0          0          0          726          701  
         338          0          0          70,961             
         338          0          0          453,540             
         0          (48,801)          0          (48,801        *  
           
         0          (72)          0          (72        (72)  
         0          (48,873)          0          (48,873           
         0          (48,873)          0          (48,873           

* Declaration waived in line with IFRS 7.29 (a). For these instruments carrying amount is a reasonable approximation of fair value.

** Declaration waived in line with IFRS 7.29 (d).

 

                

 

 

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36    Group Interim Statement                            

 

                

 

December 31, 2018
(in 000’ €)
      Hierarchy
Level
        Not classified
into a
Measurement
Category
        Financial Assets at
Amortized Cost
        Financial Assets
at Fair Value
(Through Profit
or Loss)
            
                   
                     
Cash and Cash Equivalents       *                   45,460         0            
Financial Assets at Fair Value through Profit or Loss       1                   0         44,581                                   
Other Financial Assets at Amortized Cost       *                   268,923         0            
Accounts Receivable       *                   17,733         0            
Other Receivables                                                  
thereof Financial Assets       *                   81                      
thereof Forward Exchange Contracts used for Hedging       2                   0         66            
Current Assets                           332,197         44,647            
Other Financial Assets at Amortized Cost, Net of Current Portion       2                   95,749         0            
Shares at Fair Value through Other Comprehensive Income       3                   0         0            
Prepaid Expenses and Other Assets, Net of Current Portion                                                  
thereof Non-Financial Assets       n/a         2,271                                
thereof Restricted Cash       2                   711         0            
Non-current Assets                 2,271         96,460         0            
Total                 2,271         428,657         44,647            
Accounts Payable and Accruals       *                   0         0            
Current Liabilities                           0         0            
Convertible Bonds - Liability Component       2                   0         0            
Non-current Liabilities                           0         0            
Total                           0         0            

* Declaration waived in line with IFRS 7.29 (a). For these instruments carrying amount is a reasonable approximation of fair value.

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   37

 

         

Financial Assets at

Fair Value (Through

Other

Comprehensive

Income)

          

Financial Liabilities at

Amortized Cost

      

Financial Liabilities at

Fair Value

        

Total Carrying

Amount

                   Fair value
                                                              
         0        0      0        45,460        *
                          
         0        0      0        44,581        44,581
         0        0      0        268,923        *
         0        0      0        17,733        *
                                  147         
                                  81        *
                          
         0        0      0        66        66
         0        0      0        376,844         
                          
         0        0      0        95,749        95,749
         232        0      0        232        232
                          
                                  2,982         
                                  2,271        n/a
         0        0      0        711        701
         232        0      0        98,963         
         232        0      0        475,807         
         0        (44,761)      0        (44,761      *
         0        (44,761)      0        (44,761       
         0        (72)      0        (72      (72)
         0        (72)      0        (72       
         0        (44,833)      0        (44,833       

The change in shares at fair value through other comprehensive income in the first half of 2019 is shown below.

 

in 000’ €    01/01/2019      Additions      Disposals      Through Other
Comprehensive
Income
     Through Profit or
Loss
     06/30/2019  
                 
Shareholdings      232        0        0        106        0        338  

As of June 30, 2019, the fair value of the investment was measured at € 0.3 million (December 31, 2018: € 0.2 million). The increase of € 0.1 million was recognized directly in equity.

The significant unobservable input parameters used in the measurement were corporate planning assumptions, the probability-weighted estimate of cash flows and the discount rate. From the information currently available, a material change in corporate planning is not considered likely and therefore the cash flow forecasts used are considered as a suitable basis for determining the fair value. A change in the pre-tax WACC of +/- 1.0% would cause a € 0.1 million lower or € 0.1 million

 

                

 

 

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38    Group Interim Statement                            

 

                

higher amount of equity. A sensitivity analysis for changes in cash flows was not performed because the cash flows have already been probability-adjusted in the fair value calculation to reflect the probabilities of success in the various stages of development. There are no significant relationships between the significant unobservable input parameters.

 

  LOGO

Changes in Stockholder’s Equity

COMMON STOCK

On June 30, 2019, the Company’s common stock including treasury stock amounted to € 31,839,572 (December 31, 2018: € 31,839,572).

As of June 30, 2019, the value of treasury shares decreased to € 9,442,544 from € 10,398,773 on December 31, 2018. This decline resulted from the transfer of 23,738 of the Company’s own shares in the amount of € 877,356 from the performance-based 2015 Long-Term Incentive Plan (LTI Plan) to the Management Board and Senior Management Group. The vesting period for this LTI program expired on April 1, 2019 and provided beneficiaries with a six-month term until October 14, 2019 to receive a total of 52,328 treasury shares. In addition, a total of 2,134 treasury shares in the amount of € 78,873 were transferred to related persons. As a result of these transactions, MorphoSys held 255,164 treasury shares as of June 30, 2019 (December 31, 2018: 281,036 treasury shares).

ADDITIONAL PAID-IN CAPITAL

On June 30, 2019, additional paid-in capital amounted to € 622,013,000 (December 31, 2018: € 619,908,453). The increase totaling € 2.104.547 resulted mainly from the allocation of personnel expenses from share-based payments in the amount of € 3,060,776. This was partly compensated by the decline from the reclassification of own shares related to the allocation of shares in the amount of € 877,356 from the 2015 Long-Term Incentive Plan and the allocation of own shares to related persons in the amount of € 78,873.

OTHER COMPREHENSIVE INCOME RESERVE

On June 30, 2019, the other comprehensive income reserve amounted to € -73,316 (December 31, 2018: € -210,890). As of June 30, 2019, this reserve included changes in the fair value of equity instruments of € -21,458 (December 31, 2018: € -127,458) and currency losses from the consolidation of € -51.858 (December 31, 2018: € -83,432).

 

  LOGO

Changes in Stock Options, Convertible Bonds, and Performance Shares

In the first six months of 2019, there were no convertible bonds issued to the Management Board, Senior Management Group or employees.

In April 2019 under the 2019 Stock Option Plan (SOP), a total of 76,482 stock options were issued to the Management Board, Senior Management Group and certain Company employees who were not part of the Senior Management Group. Further details can be found in Note 7.

In April 2019 under the 2019 Long-Term Incentive Plan (LTI Plan), a total of 22,763 performance shares were issued to the Management Board, Senior Management Group and certain Company

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   39

 

                

employees who were not part of the Senior Management Group. Further details can be found in Note 8.

In April 2019 under the MorphoSys US Inc. - 2019 Long-Term Incentive Plan (LTI Plan), a total of 14,283 performance shares were issued to the President and selected employees of MorphoSys US Inc. Further details can be found in Note 9.

After the expiration of the four-year vesting period, the Management Board, Senior Management Group and former members of the Senior Management Group who have since left the Company were granted a six-month term to receive a total of 52,328 shares from the 2015 LTI program. As of June 30, 2019, a total of 23,738 shares from the 2015 LTI program were transferred to the program’s beneficiaries.

After the expiration of the four-year vesting period, the Management Board and Senior Management Group have a term until March 31, 2020 to exercise a total of 436,585 convertible bonds from the 2013 program. As of June 30, 2019, a total of 239,552 conversion rights from this program had been exercised and thereby created the same number of shares.

 

  LOGO

Stock Options

On April 1, 2019, MorphoSys established a stock option plan (SOP) for the Management Board, the Senior Management Group and selected employees of the Company who are not members of the Senior Management Group (beneficiaries). In accordance with IFRS 2, the program is considered an equity-settled share-based payment and is accounted for accordingly. The grant date was April 1, 2019 and the vesting period/performance period is four years. Each stock option grants up to two subscription rights to shares of the Company. The subscription rights vest each year by 25% during the four-year vesting period, provided that the performance criteria specified for the respective period have been 100% fulfilled. The number of subscription rights vested per year is calculated based on the key performance criteria of the absolute MorphoSys share price performance and the relative MorphoSys share price performance compared to the Nasdaq Biotechnology Index and the TecDAX Index. The performance criteria can be met annually up to a maximum of 200%. If the share price development falls short of the program’s performance parameters, the target achievement for that year is 0 %.

The exercise price, derived from the average market price of the Company’s shares in the XETRA closing auction on the Frankfurt Stock Exchange from the 30 trading days prior to the issue of the stock options, is € 87.86.

MorphoSys reserves the right to settle the exercise of stock options through either newly created shares from Conditional Capital 2016-III or, alternatively, through the issuance of treasury shares or in cash should the exercise from Conditional Capital 2016-III not be possible. The exercise period is three years after the end of the four-year vesting period/performance period, which is March 31, 2026.

If a member of the Management Board ceases to hold an office at MorphoSys Group prior to the end of the four-year vesting period/performance period, the Management Board member (or the member’s heirs) would be entitled to a precise daily pro rata amount of subscription rights.

 

                

 

 

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40    Group Interim Statement                            

 

                

If a member of the Management Board ceases to hold an office at MorphoSys Group for good reason as defined by Section 626 (2) of the German Civil Code (BGB), all unexercised stock options will be forfeited without any entitlement to compensation.

If a cumulative absence of more than 90 days occurs during the four-year vesting period/performance period, the beneficiary is entitled to a precise daily pro rata amount of subscription rights. Absence is defined as either a continued period of lost work time due to illness or inactivity of a beneficiary or employment relationship without continued pay.

If a change of control occurs during the four-year vesting period, the stock options will become fully vested. In this case, however, the right to exercise the stock options arises only at the end of the four-year vesting period.

As of April 1, 2019, a total of 76,482 stock options had been granted to beneficiaries, of which 31,395 had been granted to the Management Board, 38,005 to the Senior Management Group and 7,082 to selected Company employees who do not belong to the Senior Management Group. The stated number of stock options granted is based on 100% target achievement. The fair value of the stock options on the grant date was € 31.81 per stock option. In the period from the grant date to June 30, 2019, no beneficiaries left MorphoSys, and no stock options forfeited. For the calculation of personnel expenses resulting from share-based payment under the 2019 Stock Option Plan, the assumption is that four beneficiaries would leave the Company during the four-year period.

The fair value of the stock options from the 2019 Stock Option Plan was determined using a Monte Carlo simulation. The expected volatility is based on the development of the share price volatility of the last four years. Furthermore, the calculation of fair value equally considered the performance criteria of the absolute and relative performance of MorphoSys shares compared to the development of the Nasdaq Biotech Index and the TecDAX Index. The parameters of the program are listed in the table below.

 

          April 2019 Stock Option Plan  
    

Share Price on Grant Date in €

       85.00  

Strike Price in €

       87.86  

Expected Volatility of the MorphoSys share in %

       37.76  

Expected Volatility of the Nasdaq Biotech Index in %

       18.61  

Expected Volatility of the TecDAX Index in %

       26.46  

Performance Term of Program in Years

       4.0  

pDividend Yield in %

       n/a  

Risk-free Interest Rate in %

       between 0.02 and 0.13  

 

  LOGO

Long-Term Incentive Plan

On April 1, 2019, MorphoSys established another Long-Term Incentive Plan (LTI Plan) for the Management Board, the Senior Management Group and selected employees of the Company who are not members of the Senior Management Group (beneficiaries). According to IFRS 2, this program is considered a share-based payment program with settlement in equity instruments

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   41

 

                

and is accounted for accordingly. The LTI plan is a performance-related share plan and will be paid out in ordinary shares (performance shares) of MorphoSys AG if predefined key performance criteria are achieved. The grant date was April 1, 2019, and the vesting/performance period is four years. If the predefined performance criteria for the respective period are fully met, 25% of the performance shares become vested in each year of the four-year vesting period. The number of performance shares vested per year is calculated based on key performance criteria comprising the absolute and the relative MorphoSys share price performance compared to the Nasdaq Biotechnology Index and the TecDAX Index. The performance criteria can be met annually up to a maximum of 300% and up to 200% for the entire four-year period. If the specified performance criteria are met by less than 0 % in one year, no shares will be earned for that year. In any case, the maximum pay-out at the end of the four-year period is limited by a factor determined by the Group, which generally amounts to 1. However, in justified cases, the Supervisory Board may set this factor freely between 0 and 2, for example, if the level of payment is regarded as unreasonable in view of the general development of the Company. The right to receive a certain allocation of shares under the LTI plan, however, occurs only at the end of the four-year vesting/performance period. At the end of the four-year vesting period, there is a six-month term during which the Company can transfer the performance shares to the beneficiaries.

If the number of repurchased shares is not sufficient for servicing the LTI plan, MorphoSys reserves the right to pay a certain amount of the LTI plan in cash equal to the amount of the performance shares at the end of the vesting period, provided the cash amount does not exceed 200% of the fair value of the performance shares on the grant date.

If a member of the Management Board ceases to hold an office at MorphoSys Group prior to the end of the four-year vesting period/performance period, the Management Board member (or the member’s heirs) is entitled to a precise daily pro rata amount of performance shares.

If a member of the Management Board ceases to hold an office at MorphoSys Group for good reason as defined by Section 626 (2) of the German Civil Code (BGB), the beneficiary will not be entitled to performance shares.

If a cumulative absence of more than 90 days occurs during the four-year vesting period/performance period, the beneficiary is entitled to a precise daily pro rata amount of performance shares. Absence is defined as either a continued period of lost work time due to illness or inactivity of a beneficiary or employment relationship without continued pay.

If a change of control occurs during the four-year vesting period, all performance shares will become fully vested. In this case, the right to receive a certain allocation of performance shares under the LTI plan occurs at the end of the four-year vesting period at the earliest.

A total of 22,763 of these shares were granted to beneficiaries on April 1, 2019 with 9,347 shares granted to the Management Board, 11,306 shares granted to the Senior Management Group and 2,110 shares allocated to selected employees of the Company who are not members of the Senior Management Group. The number of shares granted is based on 100% target achievement and a company factor of 1. The fair value of the performance shares on the grant date was € 106.85 per share. From the grant date until June 30, 2019, no beneficiaries have left MorphoSys, and no stock options have been forfeited. For the calculation of the personnel expenses from share-

 

                

 

 

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Table of Contents
42    Group Interim Statement                              

 

                

based payment under the 2019 LTI plan, the assumption is that four beneficiaries would leave the Company during the four-year period.

The fair value of the performance shares from the 2019 Long-Term Incentive Plan was determined using a Monte Carlo simulation. The expected volatility is based on the development of the share volatility of the last four years. Furthermore, the calculation of fair value equally considered the performance criteria of the absolute and relative performance of MorphoSys shares compared to the development of the Nasdaq Biotech Index and the TecDAX Index. The parameters of the program are listed in the table below.

 

           April 2019 Long-Term
Incentive Program
 
               
     

Share Price on Grant Date in €

         85.00  

Strike Price in €

         n/a  

Expected Volatility of the MorphoSys share in %

         37.76  

Expected Volatility of the Nasdaq Biotech Index in %

         18.61  

Expected Volatility of the TecDAX Index in %

         26.46  

Performance Term of Program in Years

         4.0  

Dividend Yield in %

         n/a  

Risk-free Interest Rate in %

         between 0.02 and 0.13  

 

  LOGO

MorphoSys US Inc. – 2019 Long-Term Incentive Plan

On April 1, 2019, MorphoSys established a Long-Term Incentive Plan (LTI Plan) for the President and selected employees of MorphoSys US Inc. (beneficiaries). According to IFRS 2, this program is considered a share-based payment program with settlement in equity instruments and is accounted for accordingly. The LTI plan is a performance-related share plan and will be paid out in ordinary shares (performance shares) of MorphoSys AG if predefined key performance criteria are achieved. The plan has a term of four years and comprises four performance periods with a term of one year each. If the predefined performance criteria for the respective period are fully met, 25% of the performance shares become vested in each year. The number of shares vested per year is calculated based on key performance criteria of MorphoSys US Inc. during the annual performance period. The performance criteria can be met annually up to a maximum of 125%. If the specified performance criteria are met by less than 0% in one year, no shares will be earned for that year. At the end of each of the one-year performance periods, there is a six-month term during which the Company can transfer the performance shares to the beneficiaries.

If the number of repurchased shares is not sufficient for servicing the LTI plan, MorphoSys reserves the right to pay a certain amount of the LTI plan in cash in the amount of the performance shares at the end of the vesting period, provided the cash amount does not exceed 200% of the average share price of MorphoSys shares in the XETRA closing auction on the Frankfurt Stock Exchange from the 30 trading days prior to the granting of the performance shares.

If a beneficiary ceases to hold an office or terminates his/her employment at MorphoSys US Inc. prior to the end of the four-year performance period, the beneficiary is entitled to a precise daily

 

                

 

 

                       MorphoSys – II/2019


Table of Contents
Group Interim Statement                          LOGO   43

 

                

pro rata amount of performance shares for the performance periods already completed or started.

A total of 14,283 own shares were granted to US beneficiaries on April 1, 2019 with 5,065 shares granted to the President and 9,218 shares granted to selected employees of MorphoSys US Inc. The stated number of shares granted is based on 100% target achievement. The fair value of the performance shares on June 30, 2019 was € 84.45 per share. From April 1 to June 30, 2019, no US beneficiaries left MorphoSys US Inc., and no stock options forfeited. For the calculation of the personnel expenses from share-based payment under the 2019 LTI plan, the assumption is that one beneficiary would leave the Company during the four-year period.

 

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Personnel Expenses Resulting from Share-Based Payments

In the first six months of 2019, personnel expenses resulting from share-based payments totaling € 3.1 million were recognized in the income statement (Q1-Q2 2018: € 3.8 million). In 2019, this amount resulted solely from share-based payments settled with equity instruments, of which an amount of € 1.5 million was related to personnel expenses associated with LTI programs (Q1-Q2 2018: € 1.0 million) and € 1.6 million (Q1-Q2 2018: € 0.7 million) to stock options.

 

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Managers’ Transactions

The Group engages in business relationships with its Management Board and Supervisory Board members as related parties. In addition to cash compensation, the Company has granted stock options, convertible bonds and performance shares to members of the Management Board.

The tables below show the shares, stock options, convertible bonds and performance shares held by the members of the Management Board and Supervisory Board, as well as the changes in the members’ ownership in the first six months of 2019.

 

                

 

 

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SHARES

 

         01/01/2019           Additions           Sales           06/30/2019    
                                         

Management Board

                                       

Dr. Simon Moroney

      483,709           0           0           483,709    

Jens Holstein

      17,017           0           0           17,017    

Dr. Malte Peters

      12,818           0           9,505           3,313    

Dr. Markus Enzelberger

      1,676           0           0           1,676    

Total

      515,220           0           9,505           505,715    
                                         

Supervisory Board

                                       

Dr. Marc Cluzel

      500           0           0           500    

Dr. Frank Morich

      1,000           0           0           1,000    

Michael Brosnan

      0           0           0           0    

Sharon Curran 1

      -           0           0           0    

Dr. George Golumbeski

      0           0           0           0    

Wendy Johnson

      500           0           0           500    

Krisja Vermeylen

      350           0           0           350    

Total

      2,350           0           0           2,350    

STOCK OPTIONS

 

         01/01/2019           Additions           Forfeitures           Exercises           06/30/2019    
                                                   

Management Board

                                                 

Dr. Simon Moroney

      22,395           10,587           0           0           32,982    

Jens Holstein

      14,673           6,936           0           0           21,609    

Dr. Malte Peters

      14,673           6,936           0           0           21,609    

Dr. Markus Enzelberger

      11,742           6,936           0           0           18,678    

Total

      63,483           31,395           0           0           94,878    

CONVERTIBLE BONDS

 

         01/01/2019           Additions           Forfeitures           Exercises           06/30/2019    
                                                   

Management Board

                                                 

Dr. Simon Moroney

      88,386           0           0           0           88,386    

Jens Holstein

      30,000           0           0           0           30,000    

Dr. Malte Peters

      0           0           0           0           0    

Dr. Markus Enzelberger

      0           0           0           0           0    

Total

      118,386           0           0           0           118,386    

 

                

 

 

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PERFORMANCE SHARES

 

          01/01/2019          Additions          Forfeitures          Allocations 2          06/30/2019  
                                                        
           

Management Board

                                                      

Dr. Simon

Moroney

       27,050          3,152          0          0          30,202  

Jens Holstein

       17,936          2,065          0          0          20,001  

Dr. Malte Peters

       5,132          2,065          0          0          7,197  

Dr. Markus

Enzelberger

       7,031          2,065          0          0          9,096  

Total

       57,149          9,347          0          0          66,496  

1 Sharon Curran has joined the Supervisory Board of MorphoSys AG on May 22, 2019.

2 Allocations are made as soon as performance shares are transferred within the six-month term after the end of the four-year waiting period.

The Supervisory Board of MorphoSys AG does not hold any stock options, convertible bonds or performance shares.

 

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Transactions with Related Parties

Excluding the transactions described under “Managers’ Transactions”, there were no further transactions carried out with related parties in the first six months of 2019. As of June 30, 2019, the Senior Management Group of MorphoSys AG held 103,280 stock options (December 31, 2018: 72,604 stock options), 11,233 convertible bonds (December 31, 2018: 11,233 convertible bonds) and 70,842 performance shares (December 31, 2018: 83,660 performance shares), which were granted by the Company.

As of June 30, 2019, the President of MorphoSys US Inc. held 5.065 performance shares (December 31, 2018: 0 performance shares), which were granted by the Company. A new stock option program and a new performance share program were issued to the Senior Management Group of MorphoSys AG and a new performance share program was issued to the President of MorphoSys US Inc. during the first six months of 2019. Further details can be found in Notes 7, 8 and 9.

On April 1, 2019, the Senior Management Group was allocated 26,106 shares from the 2015 LTI program with a six-month term to receive these shares. As of June 30, 2019, the Senior Management Group had exercised options to receive 19,939 shares.

 

                

 

 

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Subsequent Events

On July 8, 2019, MorphoSys and Vivoryon Therapeutics AG announced that they have entered into an agreement under the terms of which MorphoSys has obtained an exclusive option to license Vivoryon’s small molecule QPCTL inhibitors in the field of oncology. The option covers worldwide development and commercialization for cancer of Vivoryon’s family of inhibitors of the glutaminyl-peptide cyclotransferase-like (QPCTL) enzyme, including its lead compound PQ912. In exchange, MorphoSys has committed to investing up to € 15 million in a minority stake in Vivoryon Therapeutics as part of a capital raise planned for later this year.

 

                

 

 

                       MorphoSys – II/2019


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Responsibility Statement

“To the best of our knowledge, and in accordance with the applicable accounting principles for interim financial reporting, the interim consolidated financial statements give a true and fair view of the Group’s net assets, financial position and results of operations, and the group interim management report provides a fair view of the development and performance of the business and the position of the Group together with a description of the principal opportunities and risks associated with the Group’s expected development during the remainder of the financial year.”

Planegg, July 23, 2019

 

Dr. Simon Moroney

  

Jens Holstein

  

Chief Executive Officer

  

Chief Financial Officer

  

Dr. Malte Peters

  

Dr. Markus Enzelberger

  

Chief Development Officer

  

Chief Scientific Officer

  

 

                

 

 

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Auditor’s Review Report

TO MORPHOSYS AG, PLANEGG:

We have reviewed the condensed consolidated interim financial statements – comprising the consolidated income statement, consolidated statement of comprehensive income, consolidated balance sheet, consolidated statement of changes in stockholders’ equity, consolidated statement of cash flows and notes to the interim consolidated financial statements – and the interim group management report of MorphoSys AG for the period from January 1 to June 30, 2019, which are part of the half-year financial report pursuant to Article 115 WpHG (“Wertpapierhandelsgesetz”: German Securities Trading Act). The preparation of the condensed consolidated interim financial statements in accordance with the IFRS applicable to interim financial reporting as adopted by the EU and of the interim group management report in accordance with the provisions of the German Securities Trading Act applicable to interim group management reports is the responsibility of the parent Company’s Management Board. Our responsibility is to issue a review report on the condensed consolidated interim financial statements and on the interim group management report based on our review.

We conducted our review of the condensed consolidated interim financial statements and the interim group management report in accordance with German generally accepted standards for the review of financial statements promulgated by the Institut der Wirtschaftsprüfer (Institute of Public Auditors in Germany) (IDW). Those standards require that we plan and perform the review so that we can preclude through critical evaluation and with moderate assurance that the condensed consolidated interim financial statements have not been prepared, in all material respects, in accordance with the IFRS applicable to interim financial reporting as adopted by the EU and that the interim group management report has not been prepared, in all material respects, in accordance with the provisions of the German Securities Trading Act applicable to interim group management reports. A review is limited primarily to inquiries of Company personnel and analytical procedures and therefore does not provide the assurance attainable in a financial statement audit. Since, in accordance with our engagement, we have not performed a financial statement audit, we cannot express an audit opinion.

Based on our review, no matters have come to our attention that lead us to presume that the condensed consolidated interim financial statements have not been prepared, in all material respects, in accordance with the IFRS applicable to interim financial reporting as adopted by the EU or that the interim group management report has not been prepared, in all material respects, in accordance with the provisions of the German Securities Trading Act applicable to interim group management reports.

Munich, July 23, 2019

PricewaterhouseCoopers GmbH

Wirtschaftsprüfungsgesellschaft

 

Stefano Mulas

  

Holger Lutz

  

                                       

Wirtschaftsprüfer (German Public Auditor)

  

Wirtschaftsprüfer (German Public Auditor)

  

 

                

 

 

                       MorphoSys – II/2019


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Imprint

MorphoSys AG

Semmelweisstr. 7

82152 Planegg

Germany

Tel.:

 

+49-89-89927-0

Fax:

 

+49-89-89927-222

Email:

 

info@morphosys.com

www.morphosys.com

Corporate Communications and Investor Relations

Tel.:

 

+49 -89-89927-404

Fax:

 

+49 -89-89927-5404

Email:

 

investors@morphosys.com

Published on August 6, 2019

This half-year report is also available in German and may be downloaded from the Company’s website (PDF).

Concept and Design

3st kommunikation GmbH, Mainz

Translation

Klusmann Communications, Niedernhausen

Produced in-house using firesys.

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group. Tremfya® is a trademark of Janssen Biotech, Inc.

 

                

 

 

MorphoSys – II/2019                          


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Financial Calendar 2019

 

MARCH 13, 2019

 

PUBLICATION OF 2018 YEAR-END RESULTS

MAY 7, 2019

 

PUBLICATION OF FIRST QUARTER INTERIM STATEMENT 2019

MAY 22, 2019

 

2019 ANNUAL GENERAL MEETING IN MUNICH

AUGUST 6, 2019

 

PUBLICATION OF 2019 HALF-YEAR REPORT

OCTOBER 29, 2019

 

PUBLICATION OF THIRD QUARTER INTERIM STATEMENT 2019

 

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MorphoSys AG

Semmelweisstr. 7

82152 Planegg

Germany

Tel.: +49-89-89927-0

Fax: +49-89-89927-222

www.morphosys.com