On August 1, 2018 MorphoSys AG reported its results for the second quarter of 2018(Press release, MorphoSys, AUG 1, 2018, View Source/medien-investoren/mediencenter/morphosys-ag-gibt-ergebnisse-des-zweiten-quartals-2018-bekannt" target="_blank" title="View Source/medien-investoren/mediencenter/morphosys-ag-gibt-ergebnisse-des-zweiten-quartals-2018-bekannt" rel="nofollow">View Source [SID1234528298]).
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The company has continued to expand its pipeline of proprietary and partner-developed programs and established a presence in the US to prepare for commercialization
Conference Call and Webcast on August 2, 2018 at 2:00 pm CEST
– ongoing discussions with the US Food and Drug Administration (FDA) on marketing approval of MOR208 as a potential treatment for aggressive lymphoma (DLBCL) within the existing status of the treatment breakthrough
– First clinical data from the ongoing Phase 2 trial with MOR208 plus idelalisib in CLL presented at the annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper)
– Jennifer Herron takes over leadership of the newly formed MorphoSys US Inc. and is responsible for building commercial structures for MOR208
– MorphoSys and Galapagos sign a worldwide licensing agreement with Novartis for MOR106. MorphoSys and Galapagos will jointly receive an upfront payment of € 95 million and significant potential future milestone payments and royalties in the double-digit percentage range
– Partner Janssen starts phase 2/3 program with Tremfya (R) in Crohn’s disease
– Partner Roche launches phase 3 trial with gantenerumab in patients with early Alzheimer’s disease
– US Nasdaq IPO and successful capital increase with gross proceeds of $ 239 million completed in April 2018
– Liquidity position increased to 450.5 million euros (as at 30 June 2018)
– Following the signing of a license agreement with Novartis for MOR106 and subject to US antitrust approval, MorphoSys is increasing its financial guidance for 2018 and expects sales of between EUR 67 and 72 million, EBIT of EUR -55 to -65 million and expenses for the development of proprietary programs and technology development from 87 to 97 million euros
MorphoSys AG (Prime Standard Segment, TecDAX, NASDAQ: MOR) reported its results for the second quarter of 2018.
"MorphoSys has made excellent progress in many areas during the quarter, and we have continued our constructive discussions with the FDA on a possible route to market approval for MOR208 for the treatment of aggressive lymphoma (DLBCL) and positive data from a current Phase 2 trial Study with MOR208 in chronic lymphocytic leukemia (CLL), "commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "With the formation of our new US subsidiary MorphoSys US Inc. and the appointment of Jennifer Herron as their director, we have laid the foundation for a strong sales presence to prepare for the potential future commercialization of MOR208, subject, of course, to approval for this development Drug by the FDA. "
"We are also very pleased with the progress made by our partners, notably the successful marketing of Tremfya (R) to treat psoriasis by Janssen, as well as the launch of additional pivotal development programs with Tremfya (R) in Crohn’s disease by Janssen and Gantenerumab in Alzheimer’s by Roche, "Dr. Moroney continues.
"An exciting quarter is behind us, and MorphoSys’s recent corporate developments are giving us an optimistic outlook for the future: In April, we completed our IPO on Nasdaq and signed an exclusive license agreement with Novartis for MOR106 shortly after the end of the quarter," said Jens Holstein , Chief Financial Officer of MorphoSys AG. "Our strong financial position allows us to provide the necessary resources for our most advanced MOR208 program, to continue developing our remaining pipeline programs and to expand our commercial activities in the US."
Financial Report for the second quarter of 2018 (IFRS, all figures rounded)
In the second quarter of 2018, MorphoSys continued to focus on drug discovery and development, both independently and for partners. Consolidated revenues in the second quarter of 2018 came to EUR 8.1 million (Q2 2017: EUR 11.7 million). The expected decrease compared to the second quarter of the previous year mainly results from the termination of the partnership with Novartis in 2017. As Janssen’s contractually agreed revenue share for the second quarter of 2018 has not yet been received due to the reporting periods of Janssen and MorphoSys, Based on Janssen / J & J’s publicly announced Tremfya (R) sales revenues, the second-quarter 2018 Tremfya (R) revenue was recognized in the second quarter of 2018.
Im Segment Proprietary Development konzentriert sich MorphoSys auf die Erforschung und Entwicklung eigener Produktkandidaten in den Bereichen Krebs und entzündliche Erkrankungen. In Q2 2018 verzeichnete dieses Segment Umsätze von 0,1 Mio. Euro (Q2 2017: 0,3 Mio. Euro). Im Segment Partnered Discovery setzt MorphoSys seine firmeneigene Technologie ein, um neue Antikörper für Pharmaunternehmen zu generieren. Das Unternehmen profitiert von den Entwicklungsfortschritten der Partner in Form von finanzierten Forschungsleistungen, Lizenzgebühren, erfolgsbasierten Meilensteinzahlungen und Tantiemen (Umsatzbeteiligungen). Im ersten Quartal 2018 beliefen sich die Umsätze in diesem Segment auf 8,1 Mio. Euro (Q2 2017: 11,5 Mio. Euro).
Die gesamten betrieblichen Aufwendungen erreichten im zweiten Quartal 2018 eine Höhe von 32,7 Mio. Euro (Q2 2017: 27,5 Mio. Euro). Die Aufwendungen für die Entwicklung eigener Produkte und Technologieentwicklung beliefen sich auf 23,7 Mio. Euro (Q2 2017: 18,6 Mio. Euro). Die Zunahme im Vergleich zum Vorjahr ist vor allem auf die Kosten für die Weiterentwicklung von MOR208 zurückzuführen.
Earnings before interest and taxes (EBIT) amounted to € -24.1 million in the second quarter of 2018 (Q2 2017: € -15.4 million). The Proprietary Development segment generated EBIT of
€ -24.6 million (Q2 2017: € -18.3 million). EBIT in the Partnered Discovery segment amounted to € 5.5 million (Q2 2017: € 6.8 million).
Consolidated net income amounted to EUR -23.5 million in the second quarter of 2018 (Q2 2017: EUR -16.1 million). Earnings per share reached -0.76 euros (Q2 2017: -0.56 euros).
At the end of the second quarter of 2018, MorphoSys had cash and cash equivalents of € 450.5 million, compared to € 312.2 million at December 31, 2017. This cash and cash equivalents are shown in the balance sheet in the following items: cash and cash equivalents ; financial assets at fair value, with changes recognized in profit or loss, and other current and non-current financial assets at amortized cost. The increase in cash and cash equivalents resulted primarily from the capital increase in the context of the successful Nasdaq IPO in April 2018 with gross proceeds of $ 239 million. Part of the cash and cash equivalents were used for operating expenses in the second quarter of 2018.
The total number of shares outstanding was 31,808,035 at the end of the second quarter of 2018 (31 December 2017: 29,420,758). The main reason for the increase in the number of shares was the capital increase in connection with the listing on the Nasdaq in April 2018.
Result for the first half of 2018
In the first six months of 2018, Group sales amounted to € 10.9 million (Q1-Q2 2017: € 23.6 million). Expenses for the development of own products and technology development amounted to 39.2 million Euro in the first six months of 2018 (Q1-Q2 2017: 37.3 million Euro). EBIT in the first six months of 2018 was thus EUR -43.2 million, compared with EUR -30.3 million in the first half of 2017.
Financial forecast and operational outlook for 2018
Following the recent signing of an agreement with Novartis for MOR106 and subject to the approval of the US antitrust authorities, MorphoSys is raising its financial guidance for 2018. Subject to approval by the US antitrust authorities, MorphoSys expects revenues of € 67 million to € 72 million and Earnings before interest and taxes (EBIT) of € -55 million to € -65 million. R & D expenses for proprietary programs and technology development are expected in a range of € 87 million to € 97 million. This forecast does not include additional revenues from potential future collaborations and / or licensing partnerships nor effects from possible in-licensing or development partnerships for new drug candidates.
In the Proprietary Development segment, MorphoSys expects the following events and activities for the current year:
MOR208
– L-MIND: Continued analysis of all 81 patients with relapsed / refractory diffuse large B-cell lymphoma (R / R DLBCL) enrolled in the study and presented updated clinical data at an appropriate medical conference.
– B-MIND: Continuation of the pivotal phase 3 trial with MOR208 plus bendamustine versus rituximab plus bendamustine in R / R DLBCL.
– COSMOS: continuation of Phase 2 trial with MOR208 in combination with idelalisib or Venetoclax in CLL / SLL and presentation of results from cohort B of the study (MOR208 plus Venetoclax) at an appropriate scientific conference.
– Commercial activities: Further build commercial structures for MOR208 in the US, under the umbrella of the newly formed MorphoSys US Inc., in anticipation of a potential launch, which is currently expected in 2020, subject to regulatory approval from the US Food and Drug Administration.
MOR202
– Multiple Myeloma (MM): MorphoSys has decided not to continue the development of MOR202 in MM beyond the completion of the ongoing Phase 1 / 2a trial; the final data is expected to be presented at one of the next medical conferences. MorphoSys will support its partner I-Mab as planned in the development of MOR202 for the Chinese market.
– Lung cancer (NSCLC): After Janssen discontinued a clinical trial with the CD38 antibody daratumumab in combination with a checkpoint inhibitor, MorphoSys has decided not to continue its activities in NSCLC for the time being.
– Other indications: MorphoSys continues to investigate the development of MOR202 in other indications.
MOR106: Continuing ongoing development with Galapagos as part of the new global licensing partnership with Novartis:
– Continuation of ongoing Phase 2 trial IGUANA in atopic dermatitis.
– Start of a Phase 1 study to investigate a subcutaneous formulation of MOR106.
– All future costs associated with the development of MOR106 will be borne by Novartis.
– Agreement between MorphoSys, Galapagos and Novartis is subject to approval by the US antitrust authorities.
MOR107: Continuation of pre-clinical studies of MOR107 with a focus on cancer indications to prepare a decision to conduct further clinical trials.
MOR103 / GSK3196165: Following the recent announcement by GSK that positive Phase 2b study results for GSK3196165 in rheumatoid arthritis will be presented at a future scientific conference and that the indication for osteoarthritis has been terminated, clinical data are expected to be published by GSK.
In the Partnered Discovery segment, MorphoSys 2018 expects the following events:
Tremfya (R) (Guselkumab): For several phase 3 studies in psoriasis, clinicaltrials.gov expects primary completion date in 2018, including a comparative study with Tremfya (R) and Cosentyx (R) (Secukinumab) in plaque psoriasis.
Other Affiliate Programs: Clinical data and possible regulatory milestones could be released throughout the year for many other affiliate programs.
MorphoSys will continue to expand its own development activities and review potential in-licensing, co-development and / or acquisition opportunities. In addition, the company plans to initiate further development programs of its own with the aim of maintaining and expanding the company’s position in its current therapeutic and technological fields of activity.
Percentage points ** Including MOR107, for which a Phase 1 trial with healthy volunteers was completed. MOR107 is currently undergoing preclinical research focusing on oncology. Due to ongoing studies in various indications, we continue to consider Tremfya (R) as a Phase 3 program
*** Includes MOR103 / GSK3196165, which is fully out-licensed to GSK.
MorphoSys will host a webcast public conference call on August 2, 2018, to present the financial results for the second quarter of 2018 and the outlook for 2018.
Dial-in dates for the analyst conference call (2:00 pm CEST) (Listening mode):
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Please dial in ten minutes before the start of the conference. A live webcast and the presentation will also be available at View Source . About two hours after the end of the conference, you will be able to access an audio replay synchronized with the presentation and the transcript of the conference at View Source .