MARTINSRIED and MUNICH, Germany, Feb. 25, 2015 (GLOBE NEWSWIRE) --
2014 Showed Strong Pipeline Progress
Conference call and webcast (in English) today at 2:00pm CET (1:00pm GMT/8:00am EST)
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced financial results for the year ending 31 December 2014. Group revenues from continuing operations amounted to EUR 64.0 million (2013: EUR 78.0 million) and earnings before interest and taxes (EBIT) reached EUR -5.9 million (2013: EUR 9.9 million). The consolidated net loss amounted to EUR 3.0 million (2013: net profit of EUR 13.3 million). This decline resulted primarily from non-recurring effects in relation to the out-licensing of MOR103 to GlaxoSmithKline and license fees from the sale of the AbD Serotec business unit to Bio-Rad in 2013. On 31 December 2014, the Company held liquid funds and marketable securities, as well as other financial assets, in the amount of EUR 352.8 million, compared to EUR 390.7 million on 31 December 2013.
|In EUR million*||FY 2014||FY 2013||Q4 2014||Q4 2013|
|Total Operating Expenses||70.1||67.9||19.0||18.8|
|Earnings Before Interest and Taxes (EBIT)||(5.9)||9.9||(2.2)||(4.7)|
|Profit/(Loss) from Continuing Operations||(3.0)||7.4||(1.0)||(3.5)|
|Profit/(Loss) from Discontinued Operations||-||6.0||-||0|
|Consolidated Net Profit/(Loss)||(3.0)||13.3||(1.0)||(3.5)|
|Diluted Net Profit/(Loss) per Share||(0.12)||0.54||-||-|
* Differences due to rounding
"In 2014, we reported encouraging clinical results for our lead cancer compound MOR208 in CLL and NHL and also met important regulatory milestones, which all bodes well for the future development of the compound," stated Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "With MOR209/ES414 we have added a highly innovative prostate cancer drug candidate to our growing proprietary portfolio. The focus in 2015 will be on building value in our product pipeline, with an increasing focus on our proprietary portfolio to supplement the very broad pipeline of partnered programs."
"The Company's strong financial position continues to give us flexibility with regards to strengthening and advancing our proprietary portfolio. With a solid revenue basis secured by our partnerships and EUR 352.8 million in cash and other financial assets, MorphoSys has the resources to broaden its proprietary portfolio on top of our large and maturing partnered pipeline," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "The MorphoSys pipeline has matured and now includes more programs in clinical trials and in a more advanced state than ever before."
Update on MorphoSys's Proprietary Antibody Portfolio
MorphoSys's proprietary portfolio currently comprises ten innovative development programs, of which three are in clinical development.
MOR208 - An anti-CD19 antibody for the treatment of B cell malignancies. The program is currently in three phase 2 clinical studies.
- MorphoSys and Xencor published final results from a phase 1/2a trial of MOR208 in CLL/SLL at the 2014 Annual Meeting of the American Society of Hematology (ASH).
- MorphoSys published very promising clinical data from the ongoing phase 2 trial of MOR208 in non-Hodgkin's lymphoma (NHL) at ASH.
- Ohio State University initiated a phase 2 investigator-sponsored trial (IST) to evaluate the efficacy and safety of a combination of MOR208 and lenalidomide in patients with CLL.
- During 2014, MOR208 obtained orphan drug status in the US and Europe in CLL and DLBCL and fast track designation in the US in DLBCL.
MOR103 - A fully human HuCAL antibody directed against GM-CSF, being developed in the area of inflammatory diseases, and is part of MorphoSys's collaboration with GlaxoSmithKline.
- In September 2014, positive clinical data for the MOR103 program from a phase 1b study in multiple sclerosis were presented at the ACTRIMS-ECTRIMS meeting.
MOR202 - a fully human HuCAL antibody directed against CD38, for the treatment of multiple myeloma (MM) and certain leukemias. MOR202 is currently in a phase 1/2a trial in MM, and is part of MorphoSys's collaboration with Celgene.
- The ongoing dose-escalation trial of MOR202 with a bi-weekly dosing regimen trial was expanded through the addition of cohorts on a weekly dosing schedule, with or without the addition of dexamethasone.
MOR209/ES414 - an anti-PSMA/anti-CD3 bi-specific antibody targeting prostate cancer. The compound is part of a co-development and co-commercialization agreement between MorphoSys and Emergent BioSolutions.
- MOR209/ES414 was in-licensed from Emergent BioSolutions in August 2014
Progress within MorphoSys's Partnered Pipeline
- During 2014, the number of individual therapeutic antibodies in the MorphoSys partner pipeline grew to a total of 84 (31 December 2013: 75). Of those, 19 antibodies were in clinical development, 25 in preclinical development and 40 in the discovery phase at year-end.
Guselkumab - an IL-23-specific HuCAL antibody to treat inflammatory diseases developed by Janssen
- Janssen initiated several phase 3 trials, of which three, recruiting some 2,500 psoriasis patients, are scheduled for completion in 2016.
Bimagrumab - an ActRIIB-specific fully human HuCAL antibody to treat muscle-wasting disorders developed by Novartis
- Highlighted by Novartis at its YE2014 results presentation as planned for filing in 2016 (sIBM)
Gantenerumab - an amyloid beta-targeting HuCAL antibody to treat Alzheimer's disease developed by Roche
- Roche initiated a phase 3 trial (Marguerite RoAD) in 1,000 patients with mild Alzheimer's Disease
- Termination of a phase 3 trial in prodromal Alzheimer's disease patients (SCarlet RoAD) based on pre-planned futility analysis announced in December of 2014.
Financial Review for the Fiscal Year 2014 (IFRS)
Group revenues for the full year 2014 decreased by 18 % to EUR 64.0 million (2013: EUR 78.0 million). This decline resulted primarily from non-recurring effects in relation to the out-licensing of MOR103 and a license fee in connection with the sale of the AbD Serotec. The Proprietary Development segment achieved revenues of EUR 15.0 million (2013: EUR 26.9 million), which were mainly from co-development activities with Celgene. The decline in proprietary development revenue versus 2013 was caused by an upfront payment received from GSK with the out-licensing of MOR103. Revenues in the Partnered Discovery segment included EUR 43.6 million in funded research and licensing fees (2013: EUR 48.0 million) and EUR 5.4 million in success-based payments (2013: EUR 3.0 million). The decline versus 2013 resulted from a one-time license fee associated with the sale of the AbD Serotec business unit to Bio-Rad in 2013.
Total operating expenses from continuing operations for the full year 2014 increased by 3% to EUR 70.1 million (2013: EUR 67.9 million). Total research and development expenses (R&D) rose by EUR 6.8 million to EUR 56.0 million in 2014 (2013: EUR 49.2 million). R&D expenses rose mainly due to higher costs for external laboratory services, third-party services and the amortization of intangible assets. R&D expenses for proprietary research and development, including technology development, amounted to EUR 36.4 million (2013: EUR 31.7 million). General and administrative expenses (G&A) amounted to EUR 14.1 million (2013: EUR 18.8 million). The decrease in G&A is mainly driven by lower personnel expenses and expenses for third-party services. Non-cash charges related to stock-based compensation are embedded in R&D and G&A expenses and decreased to EUR 4.0 million (2013: EUR 5.1 million). Other income and expenses amounted to EUR 0.2 million (2013: expense of EUR 0.1 million).
Earnings before interest and taxes (EBIT) from continuing operations amounted to EUR -5.9 million (2013: EUR 9.9 million). Proprietary Development showed a segment EBIT of EUR -18.4 million (2013: EUR -0.5 million), while the Partnered Discovery segment reported an EBIT of EUR 25.9 million (2013: EUR 25.4 million).
Finance income and expenses, and income from taxes, summed up to EUR 2.9 million (2013: Expenses of EUR 2.5 million). For the full year 2014, MorphoSys realized a consolidated net loss of EUR 3.0 million compared to a net profit of EUR 13.3 million in the previous year. The diluted net result per share amounted to EUR -0.12 (2013: EUR 0.54).
On 31 December 2014, the Company held liquid funds and marketable securities, as well as other financial assets (reported in the balance sheet under cash and cash equivalents, financial assets and bonds available for sale and other short-term and long-term receivables), in the amount of EUR 352.8 million, compared to EUR 390.7 million on 31 December 2013. Net cash outflow from operations in 2014 amounted to EUR 14.2 million (2013: net cash inflow of EUR 89.1 million). The number of shares issued at 31 December 2014 was 26,456,834, compared to 26,220,882 shares on 31 December 2013.
Fourth Quarter of 2014 (IFRS)
In the fourth quarter of 2014, the Company generated revenues in the amount of EUR 17.0 million, compared to EUR 14.4 million in the same quarter of 2013. Total operating expenses amounted to EUR 19.0 million in Q4, compared to EUR 18.8 million in the same quarter of 2013. The increase of operating expenses was mainly due to higher expenses for third party services. The EBIT amounted to EUR -2.2 million (Q4 2013: EUR -4.7 million). Group net loss for the fourth quarter 2014 was EUR 1.0 million, compared to a net loss of EUR 3.5 million in the fourth quarter of 2013.
Outlook for 2015
In 2015, the Company's R&D budget for proprietary drug development will rise in comparison to the previous year. The majority of these investments will flow into the clinical development of MorphoSys's most advanced drug candidates.
- MorphoSys plans to initiate two phase 2 clinical trials in H2 2015 evaluating combinations of MOR208 with lenalidomide and bendamustine in DLBCL.
- MorphoSys plans to end the ongoing phase 2 clinical mono-therapy trial of MOR208 in ALL patients to focus on a new investigator-sponsored pediatric trial using MOR208 in combination with an immune cell transplantation.
- MorphoSys and Emergent are targeting the initiation of a phase 1 clinical study to evaluate the safety, tolerability, and clinical activity of MOR209/ES414 in individuals with metastatic castration-resistant prostate cancer (mCRPC) in Q1 of 2015.
- Further investments are planned in the areas of proprietary target validation, new proprietary therapeutic antibody discovery and technology development.
MorphoSys expects Group revenues for the 2015 financial year in the amount of EUR 58 million to EUR 63 million. Based on management's current planning, R&D expenses for proprietary programs and the development of technology are expected to increase to a range of EUR 48 million to EUR 58 million in 2015. The Company expects earnings before interest and taxes (EBIT) of approximately EUR -20 million to EUR -30 million in 2015. This guidance does not include potential costs for in-licensing or acquiring further development candidates.
MorphoSys will hold its conference call and webcast today to present the Annual Financial Results 2014 and the Outlook 2015.
Dial-in number for the analyst conference call (in English) at 02:00 pm CET; 01:00 pm GMT; 08:00 am EST (listen-only):
Germany: +49 (0) 89 2444 32975
For UK residents: +44 (0) 20 3003 2666
For US residents: +1 202 204 1514
Please dial in 10 minutes before the beginning of the conference.
In addition, MorphoSys offers participants the opportunity to follow the presentation through a simultaneous slide presentation online at http://www.morphosys.com.
A live webcast, slides, webcast replay and transcript will be made available at http://www.morphosys.com.
Approximately two hours after the press conference, a slide-synchronized audio replay of the conference will be available on http://www.morphosys.com.
Consolidated Financial Statements 2014 (IFRS) are available on our website:
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 90 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.
Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
For more information, please contact:
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Associate Director Corporate Communications & IR
Manager Corporate Communications & IR
Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404