On March 2, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported financial results for the year ending December 31, 2015, as well as a financial and operational outlook on 2016.
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Financial Year 2015 results and key operational achievements 2015:
FY2015 revenues of EUR 106.2 million (2014: EUR 64.0 million) and EBIT of EUR 17.2 million (2014: EUR -5.9 million) exceed latest financial guidance.
2015 revenues and EBIT have been significantly impacted by a non-recurring effect attributable to the ending of the collaboration with Celgene.
Strong cash position of EUR 298.4 million at end of 2015 (EUR 352.8 million end of 2014).
Product pipeline further expanded in 2015 to 103 programs (89 partnered, 14 proprietary) up from 94 programs (84 partnered, 10 proprietary) at year-end 2014.
Main cancer programs MOR208 and MOR202 with encouraging phase 2 clinical data in hematological indications non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (MOR208) and multiple myeloma (MOR202).
In EUR million* FY 2015 FY 2014 Q4 2015 Q4 2014
Group Revenues 106.2 64.0 12.3 17.0
Total Operating Expenses 93.7 70.1 30.1 19.0
Earnings Before Interest and Taxes (EBIT) 17.2 (5.9) (17.5) (2.2)
Consolidated Net Profit/(Loss) 14.9 (3.0) (13.3) (1.0)
Diluted Net Profit/(Loss) per Share 0.57 (0.12) (0.51) (0.04)
* Differences due to rounding
Operational and financial outlook 2016:
Partnered discovery: Phase 3 readouts and potential filings for approval for antibodies bimagrumab in sporadic inclusion body myositis (sIBM, Novartis) and guselkumab in psoriasis (Janssen) expected.
Proprietary development: Increase in R&D activities planned to advance existing clinical programs and to begin clinical development of MOR106 and MOR107 in 2016.
R&D budget for proprietary drug development expected to increase to EUR 76 to 83 million in 2016 (2015: EUR 56.6 million). The bulk of these expenses will flow into the clinical development of MorphoSys’s most advanced proprietary drug candidates.
Revenues 2016 expected in the amount of EUR 47 to 52 million. EBIT 2016 expected in a range from EUR -58 to -68 million.
Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, stated: "The progress made in 2015 has contributed to MorphoSys now having a product pipeline that is broader and more mature than ever before. The first therapeutic antibodies are nearing market approval, bringing us closer to a product-based revenue stream that we expect will grow significantly in the years ahead. Meanwhile, our proprietary development portfolio is expanding and the two most advanced programs are approaching the decisive stage of clinical development. Across our entire pipeline, we see many programs which have the potential to transform the treatment of the diseases they address, to the benefit of all of our stakeholders, not least, the patients who they will help."
"MorphoSys’s portfolio is one of the broadest in the industry. This is supported by financial resources of close to EUR 300 million at the end of 2015 that allows us to operate from a position of strength. Our solid financial position enables us to increase R&D expenses to grow the Company’s value without losing sight of our prudent and efficient use of resources," commented Jens Holstein, Chief Financial Officer of MorphoSys AG.
Update on MorphoSys’s Proprietary Antibody Portfolio
At the end of 2015, MorphoSys’s proprietary portfolio comprised 14 (2014: 10) innovative development programs, of which 4 (2014: 3) are in clinical development.
MOR208 – An anti-CD19 antibody for the treatment of B cell malignancies.
At the 2015 ASCO (Free ASCO Whitepaper) and ASH (Free ASH Whitepaper) meetings, positive data from a phase 2a study with MOR208 in 92 patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) were presented.
At the 2015 ASH (Free ASH Whitepaper) meeting, investigators at The Ohio State University reported on an investigator-initiated trial (IIT) of a combination of MOR208 with lenalidomide in relapsed/refractory or treatment-naive CLL patients. This study has recently been amended to add MOR208 on top of ongoing therapy with ibrutinib in patients suffering a relapse.
In 2016, MorphoSys will start two clinical combination trials for MOR208 in DLBCL and one in CLL. One of the DLBCL trials is intended to transition into a pivotal study in 2017.
MOR202 – A HuCAL antibody against CD38 for treatment of multiple myeloma (MM).
Encouraging clinical data from the ongoing dose-escalation trial of MOR202 alone and/or in combination with lenalidomide or pomalidomide (IMiDs – immunomodulatory drugs) were presented at ASCO (Free ASCO Whitepaper) and ASH (Free ASH Whitepaper) 2015.
The 16 mg/kg MOR202 confirmation cohort is enrolling and the 16 mg/kg IMiDs combination cohorts will be initiated soon.
Patients receiving MOR202 plus pomalidomide have shown very encouraging responses, which have deepened considerably since first data was reported at ASH (Free ASH Whitepaper) in December 2015.
Updated clinical data will be presented at an upcoming medical conference.
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.
After examination of the initial clinical data, it was decided to adjust the dosing regimen and administration of MOR209/ES414. Clinical development will continue in 2016 using an amended clinical development plan, with recruitment to start around mid-2016.
Under the terms of the updated collaboration agreement, MorphoSys’s cost sharing in the years 2016 to 2018 and future milestone payments payable to Emergent BioSolutions by MorphoSys were reduced.
MOR103 – A HuCAL antibody directed against GM-CSF, out-licensed to GlaxoSmithKline (GSK) in 2013, is being developed by GSK in inflammatory diseases.
In the third quarter of 2015, GSK announced the commencement of a phase 2b study with MOR103 (re-named GSK3196165) in rheumatoid arthritis.
GSK plans to initiate a phase 1b/2a study in osteoarthritis of the hand in 2016.
Progress within MorphoSys’s Partnered Pipeline
During 2015, the number of therapeutic antibodies in MorphoSys’s partner pipeline grew to a total of 89 (December 31, 2014: 84). Of those, 21 antibodies were in clinical development, 25 in preclinical development and 43 in the discovery phase at year-end.
Two new antibodies entered phase 1 clinical development in 2015.
Financial Review for the Fiscal Year 2015 (IFRS)
Group revenues for the full year 2015 increased by 66 % to EUR 106.2 million (2014: EUR 64.0 million). This increase is mainly due to a contribution of approximately EUR 59 million from the recognition of deferred revenues and a one-time payment attributable to the early termination of a collaboration with Celgene. The Proprietary Development segment achieved revenues of EUR 59.9 million (2014: EUR 15.0 million), resulting from the non-recurring effect attributable to the above event. Revenues in the Partnered Discovery segment of EUR 46.3 million included EUR 42.3 million in funded research and licensing fees (2014: EUR 43.6 million) and EUR 4.0 million in success-based payments (2014: EUR 5.4 million).
Total operating expenses for the full year 2015 increased by 34 % to EUR 93.7 million (2014: EUR 70.1 million). Total research and development expenses (R&D) increased by EUR 22.7 million to EUR 78.7 million in 2015 (2014: EUR 56.0 million) mainly due to higher costs for external laboratory services and personnel. R&D expenses for proprietary research and development amounted to EUR 56.6 million (2014: EUR 36.4 million). General and administrative expenses (G&A) amounted to EUR 15.1 million (2014: EUR 14.1 million). Personnel expenses from share-based payments are included in G&A expenses and R&D expenses. These expenses amounted to EUR 3.6 million in 2015 (2014: EUR 4.0 million). Other income and expenses amounted to EUR 4.7 million (2014: income of EUR 0.2 million).
Earnings before interest and taxes (EBIT) amounted to EUR 17.2 million (2014: EUR -5.9 million). The increase is driven by one-off effects in the context of the ending of the MOR202 collaboration with Celgene in the first quarter of 2015. Proprietary Development showed a segment EBIT of EUR 10.7 million (2014: EUR -18.4 million), while the Partnered Discovery segment reported an EBIT of EUR 20.4 million (2014: EUR 25.9 million).
Finance income for 2015 amounted to EUR 3.4 million (2014: EUR 1.6 million). The Group reported income tax expenses of EUR 5.7 million (2014: tax benefit of EUR 1.3 million). Due to the positive one-off effects realized in 2015, MorphoSys generated a consolidated net profit of EUR 14.9 million compared to a net loss of EUR -3.0 million in 2014. The diluted net result per share amounted to EUR 0.57 (2014: EUR -0.12).
On 31 December 2015, the Company had a cash position of EUR 298.4 million, compared to EUR 352.8 million on December 31, 2014. In the balance sheet this cash position is reported under the positions: cash and cash equivalents; available-for-sale financial assets; bonds, available-for-sale; financial assets classified as loans & receivables; and financial assets classified as loans & receivables, net of current portion.
Net cash outflow from operating activities in 2015 totaled EUR 23.5 million (2014: cash outflow EUR 14.2 million). Resulting from the exercise of 80,848 convertible bonds in 2015, the number of shares issued rose to 26,537,682 by December 31, 2015 (December 31, 2014: 26,456,834).
Fourth Quarter of 2015 (IFRS)
In the fourth quarter of 2015, the Company generated revenues in the amount of EUR 12.3 million, compared to EUR 17.0 million in the same quarter of 2014. Total operating expenses amounted to EUR 30.1 million in Q4, compared to EUR 19.0 million in the same quarter of 2014. The increase in operating expenses was mainly due to higher expenses for third party services. The EBIT amounted to EUR -17.5 million (Q4 2014: EUR -2.2 million). Group net loss for the fourth quarter 2015 was EUR -13.3 million, compared to a net loss of EUR -1.0 million in the fourth quarter of 2014.
Outlook for 2016
In line with its intention to advance and broaden its proprietary pipeline, MorphoSys will increase its spending on proprietary drug development in comparison to the previous year. The majority of the expenses will flow into the clinical development of MorphoSys’s most advanced drug candidates.
MOR208: MorphoSys plans to initiate two phase 2 trials, the first of which will combine MOR208 and lenalidomide in DLBCL, the second of which will combine MOR208 and idelalisib in ibrutinib-refractory CLL. In the second half of 2016, the Company will start a further study in DLBCL, combining MOR208 and bendamustine. This trial is intended to lead into a pivotal study in 2017.
MOR202: MorphoSys plans to generate additional clinical data from an ongoing phase 1/2a trial in multiple myeloma (MM) evaluating the confirmation cohort of 16 mg/kg MOR202 alone as well as the cohorts and confirmation cohorts of 16 mg/kg MOR202 in combination with lenalidomide or pomalidomide.
With MOR209, MorphoSys expects to continue the phase 1 trial in metastatic castration-resistant prostate cancer (mCRPC) using an amended dosing scheme.
MorphoSys expects to start clinical development of MOR106 (jointly developed with Galapagos) and of MOR107, the first drug candidate from the Company’s acquisition of Lanthio Pharma.
In the Partnered Discovery segment, MorphoSys expects two phase 3 readouts and potential filings for approval for the antibodies bimagrumab in sIBM (Novartis) and guselkumab in psoriasis (Janssen). This would mark the first approvals of HuCAL antibodies.
MorphoSys expects Group revenues for the 2016 financial year in the range of EUR 47 to 52 million. R&D expenses for proprietary drug development are expected to rise to EUR 76 to 83 million. The Company expects earnings before interest and taxes (EBIT) in a range of between EUR -58 to -68 million. This guidance does not include any potential in-licensing or co-development of further development candidates.
MorphoSys will hold its conference call and webcast today to present the Annual Financial Results 2015 and the Outlook 2016.