Conference call and webcast (in English) to be held on November 12, 2020 at 2:00pm CET (1:00pm GMT/8:00am EST)
PLANEGG / MUNICH, GERMANY/ ACCESSWIRE / November 11, 2020 / MorphoSys AG (FSE:MOR) Prime Standard Segment; MDAX & TecDAX; (NASDAQ:MOR) reports results for the first nine months and third quarter of 2020.
Financial Results for the First Nine Months of 2020
Corporate and Program Updates for the Third Quarter
Monjuvi(R) (tafasitamab-cxix)
Felzartamab (MOR202)
MOR210/TJ210
Tremfya(R) (guselkumab)
Corporate Developments
Significant Events After the End of the Third Quarter
“Throughout the quarter, we made great progress in all dimensions of our business – from commercial to advancing our late stage clinical portfolio to accelerating our research. Despite COVID-19 challenges, our Monjuvi launch is fully on track and continues to build strong momentum in the U.S., confirming the value Monjuvi brings to patients”, said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “We are building on the strength of our R&D portfolio with two very significant new partnerships, including advancing our vision of tafasitamab as the backbone for other therapeutic combinations with our Xencor CD20xCD3 bispecifics collaboration.”
“We continuously invest in the success of our launch and the promise of our proprietary compounds aiming to help patients with a high unmet medical need as well as to generate sustainable value and return for our shareholders” commented Jens Holstein, Chief Financial Officer of MorphoSys. “With a pro-forma liquidity of approx. € 1.3 billion by end of September taking into account the convertible bond issuance in October, we are well suited to grow the company in the years ahead to the benefit of our stakeholders.”
Financial Review for the Third Quarter of 2020 (IFRS)
Group revenues for the third quarter of 2020 increased to € 22.0 million (Q3 2019: € 12.5 million). This increase resulted primarily from the first-time recognition of Monjuvi(R) (tafasitamab-cxix) product sales and from service fees for the assignment of personnel to R&D collaborations. Group revenues include revenues of US$ 5.0 million (€ 4.4 million) from the first-time recognition of Monjuvi(R) (tafasitamab-cxix) product sales. Royalties amounted to € 10.2 million (Q3 2019: € 9.3 million).
In the Proprietary Development segment, MorphoSys researches and develops its own drug candidates for cancer and inflammation. In Q3 2020, this segment recorded revenues of € 10.5 million (Q3 2019: € 1.4 million). The rise is primarily due to the Monjuvi(R) (tafasitamab-cxix) product sales and the service fees for the assignment of personnel to R&D collaborations as explained above.
In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies and thus participates in its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. Revenues in the Partnered Discovery segment slightly increased to € 11.5 million in Q3 2020 from € 11.0 million in Q3 2019.
Total operating expenses increased to € 84.0 million from € 40.3 million in the same time period last year, due to the expenditure in relation to the Monjuvi(R) (tafasitamab-cxix) U.S. commercialization as well as the further expansion of MorphoSys US Inc. Cost of sales amounted to € 3.7 million versus € 1.0 million in the same quarter of 2019, while R&D expenses rose to € 34.2 million as compared to € 25.9 million in Q3 2019. Selling expenses in Q3 2020 increased to € 32.9 million (Q3 2019: € 4.4 million) and general and administrative expenses to € 13.3 million (Q3 2019: € 9.0 million). The increase of the two latter was primarily driven by higher personnel expenses and expenses for external services in association with the Monjuvi(R) (tafasitamab-cxix) launch. Selling expenses also comprised expenses for services rendered by Incyte in connection with the joint U.S. activities.
Earnings before interest and taxes (EBIT) for the Group amounted to € -61.7 million in Q3 2020 versus € -27.0 million in Q3 of the previous year. The Proprietary Development segment reported an EBIT of € -61.7 million (Q3 2019: € -30.4 million), while the Partnered Discovery segment delivered an EBIT of € 9.3 million (Q3 2019: € 8.8 million). The consolidated net loss was € -65.3 million (Q3 2019: € -24.2 million). Basic earnings per share were € -2.00 compared to € -0.76 in Q3 2019.
On September 30, 2020, the Group’s liquidity position amounted to € 987.2 million. This liquidity position is reported on the balance sheet under the items “cash and cash equivalents”, “financial assets at fair value through profit or loss”, and current and non-current “other financial assets at amortized cost”. The cash inflow from the convertible offering in October is therefore not included in this amount.
The number of shares issued totaled 32,890,046 at the end of Q3 2020 (year-end 2019: 31,957,958).
Results for the First 9 Months 2020 (IFRS)
During the first 9 months of 2020, Group revenues increased to € 291.7 million from € 60.7 million in the same time period last year. This rise resulted primarily from the collaboration and license agreement with Incyte. Research and development expenses amounted to € 86.6 million versus € 75.3 million in the same time period last year. EBIT rose to € 101.8 million, compared to € -56.3 million for 9M 2019.
Financial Guidance and Operational Outlook for 2020
For the financial year 2020, MorphoSys increased its financial guidance. Management now expects Group revenues in the range of € 317 to € 327 million (previously: € 280 to € 290 million) and an EBIT in the range of € 10 to € 20 million (previously: € -15 to € +5 million). R&D expenses are expected to remain unchanged in the range of € 130 to € 140 million. This updated guidance reflects higher revenues from partnerships and collaborations and Tremfya(R) royalties are expected to be at the upper end of guidance. In addition, it now also includes revenues from product sales of Monjuvi(R) following its approval and subsequent launch in the U.S. This updated guidance is based on constant currency exchange rates and does not include any effects from potential in-licensing or co-development deals for new development candidates. The operational and financial guidance might potentially be impacted by the ongoing global COVID-19 crisis on MorphoSys’ business operations including but not limited to the Company’s supply chain, clinical trial conduct, as well as timelines for regulatory and commercial execution. While MorphoSys is maintaining its previously communicated guidance on its clinical trials, these could potentially be affected in terms of patient enrollment and data collection timelines, among other factors.
Ongoing Trials and Other Highlights
Monjuvi(R) (tafasitamab-cxix)
Tafasitamab
Felzartamab (MOR202)
Otilimab (MOR103/GSK3196165)
Tremfya(R) (guselkumab)
Novartis
Other partnered programs
MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.
MorphoSys continues its expansion of strategic presence of MorphoSys US Inc.
Update on the Impact of the Global COVID-19 Pandemic
MorphoSys Group Key Figures (IFRS, September 30, 2020)
in EUR million | Q3 2020 | Q3 2019 | ∆ | 9M 2020 | 9M 2019 | ∆ |
Revenues | 22.0 | 12.5 | 76% | 291.7 | 60.7 | >100% |
Total operating expenses | (84.0) | (40.3) | >(100%) | (198.5) | (117.8) | (69%) |
Cost of sales | (3.7) | (1.0) | >(100%) | 0.2 | (10.9) | >100% |
R&D expenses | (34.2) | (25.9) | (32%) | (86.6) | (75.3) | (15%) |
Selling expenses | (32.9) | (4.4) | >(100%) | (75.0) | (9.3) | >(100%) |
G&A expenses | (13.3) | (9.0) | (48%) | (37.2) | (22.4) | (66%) |
Other income/expense | 0.4 | 0.8 | (50%) | 8.7 | 0.8 | >100% |
EBIT | (61.7) | (27.0) | >(100%) | 101.8 | (56.3) | >100% |
Consolidated net profit/loss | (65.3) | (24.2) | >(100%) | 114.4 | (52.7) | >100% |
Earnings per Share, basic (in EUR) | (2.00) | (0.76) | >(100%) | 3.53 | (1.67) | >100% |
Cash position (end of period) | 987.2 | 412.4 | >100% | 987.2 | 412.4 | >100% |
Equity ratio (end of period) (in %) | 43.3 | 81.9 | (38.6PP*) | 43.3 | 81.9 | (38.6PP*) |
No. of R&D programs (end of period) | 116 | 117 | (1%) | 116 | 117 | (1%) |
No. of clinical programs (end of period)** | 27 | 29 | (7%) | 27 | 29 | (7%) |
No. of proprietary clinical programs (end of period)*** | 3 | 5 | (40%) | 3 | 5 | (40%) |
No. of products on the market (end of period)** | 2 | 1 | 100% | 2 | 1 | 100% |
* Percentage point
** Tremfya(R) (guselkumab) and Monjuvi(R) (tafasitamab-cxix) are still considered as clinical programs due to ongoing studies in various indications and/or treatment lines
*** Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK
MorphoSys will hold its conference call and webcast tomorrow, November 12, 2020, to present the 9-month financial results 2020 and the further outlook for 2020.
Dial-in number for the analyst conference call (in English) at 2:00pm CET; 1:00pm GMT; 8:00am EST:
Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
(all numbers reachable from any geography)
Participant PIN: 26740320#
Please dial in 10 minutes before the beginning of the conference.
A live webcast and slides will be made available at www.morphosys.com.
Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript of the prepared remarks will be available on www.morphosys.com.
The 9-month report 2020 (IFRS) is available online: www.morphosys.com/FinancialReports.
About Monjuvi(R) (tafasitamab-cxix)
Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.
A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.
Tafasitamab-cxix is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.
Monjuvi(R) is a registered trademark of MorphoSys AG.
XmAb(R) is a registered trademark of Xencor, Inc.
NCCN(R) and National Comprehensive Cancer Network(R) are registered trademarks of National Comprehensive Cancer Network, Inc.
About MorphoSys
MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya(R), developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys’ proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees.
More information at www.morphosys.com or MorphoSys-US.com.
Tremfya(R) is a registered trademark of Janssen Biotech, Inc.
MorphoSys Forward-Looking Statements
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding tafasitamab’s ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,” “could,” “potential,” “possible,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys’ expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab as well as the commercial performance of tafasitamab, MorphoSys’ reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys’ Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
For more information, please contact:
MorphoSys
Dr. Julia Neugebauer
Director
Tel: +49 (0) 89 / 899 27-179
Julia.Neugebauer@morphosys.com
Media Contacts:
Jeanette Bressi
Director, US Communications
Tel: +1 617-404-7816
media@morphosys.com
Sophie Petersen
Senior Specialist
Tel: +49 (0) 89 899 27 26033
media@morphosys.com
View source version on accesswire.com:
https://www.accesswire.com/616209/MorphoSys-Reports-Nine-Months-and-Third-Quarter-2020-Results
Bill passage key to supplemental oxygen access and adequate reimbursementIRVING, TX / ACCESSWIRE / March…
GREENVILLE, SC / ACCESSWIRE / March 26, 2024 / Rymedi is proud to announce its…
NORTHAMPTON, MA / ACCESSWIRE / March 26, 2024 / Quest Diagnostics At Quest for 2…
Expanding its roster of technology leaders will enhance its ability to drive innovation and deliver…
Third-party research confirms significant impact of specialty expertise on patients’ quality of life and costs…
Proven healthcare executive and life sciences strategist joins to bring groundbreaking BioFuse Multi-Tissue Welder (MTW)…