On May 3, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported its first quarter interim statement, outlining the key events of the first three months ending March 31, 2016 (Press release, MorphoSys, MAY 3, 2016, View Source [SID:1234511804]).
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Financial results for the first quarter of 2016
Group revenue in the first quarter of 2016 reached EUR 12.1 million (Q1/2015: EUR 70.4 million), and EBIT was EUR -9.7 million (Q1/2015: EUR 52.8 million). Previous-year figures included a non-recurring effect of approximately EUR 59 million.
The Group’s liquidity position on March 31, 2016 amounted to EUR 287.0 million (December 31, 2015: EUR 298.4 million).
The Company confirmed its 2016 financial year guidance for revenue in the range of EUR 47 million to EUR 52 million and EBIT in the range of EUR -58 million to EUR -68 million.
Operating highlights of the first quarter of 2016
In January, MorphoSys disclosed the receipt of a milestone payment in connection with the start of a global phase 2 clinical study. This study was initiated by Bayer and is designed to support registration of anetumab ravtansine (BAY 94-9343) as a potential new treatment for mesothelioma.
In March, MorphoSys repurchased 52,295 of its own shares in the amount of EUR 2,179,963 to be used for long-term incentive (LTI) programs, specifically the LTI Plan granted on April 1, 2016 to the Company’s Management Board and Senior Management Group.
At the end of the first quarter, MorphoSys’s product pipeline comprised a total of 104 therapeutic antibodies, 26 of which are in clinical development. Three partnered programs are currently in phase 3 trials.
Events after the end of the first quarter of 2016
In early April, MorphoSys announced the start of a phase 2 clinical combination trial which has been named L-MIND (Lenalidomide-MOR208 IN DLBCL), with MOR208 and the cancer drug lenalidomide (Revlimid) in patients with diffuse large B-cell lymphoma (DLBCL).
Also in early April, MorphoSys announced the initiation of a phase 1 trial with the Ylanthia antibody MOR106, which is being co-developed with Galapagos for the treatment of inflammatory diseases.
On April 4, 2016, MorphoSys announced that it filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech and Genmab for patent infringement. With this complaint, MorphoSys seeks redress for the infringing manufacture, use and sale of Janssen’s and Genmab’s daratumumab, an antibody targeting CD38.
On April 21, 2016, MorphoSys announced that its partner Novartis confirmed that a phase 2b/3 study examining bimagrumab (BYM338) in sporadic Inclusion Body Myositis (sIBM) did not meet its primary endpoint. Data are currently being reviewed and will inform decisions on the bimagrumab development program. Ongoing clinical trials are being continued at this time.
In EURO million* 3-Months 2016 3-Months 2015
Group Revenues 12.1 70.4
Total Operating Expenses 21.9 17.7
Other Income/Expenses 0.1 0.0
Earnings Before Interest and Taxes – EBIT (9.7) 52.8
Consolidated Net Profit / (Loss) (7.2) 40.9
Total EPS, diluted, in EURO (0.28) 1.55
* Differences due to rounding
"The proprietary portfolio is making excellent progress with the first combination trial of MOR208 now ongoing, and the start of clinical development of MOR106, an innovative new antibody from our collaboration with Galapagos," stated Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "The outcome of the phase 3 bimagrumab trial was disappointing, but we look forward to reporting on multiple milestones in 2016, including results from the registration trials for guselkumab and additional data from our broad development pipeline."
"The results for the first three months of 2016 are fully in line with our expectations. With our solid financial position, we are well-positioned to continue delivering on our research and development goals," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "We will continue to focus on the expansion of our pipeline."
Financial Review of the First Three Months of 2016 (IFRS)
In comparison to the previous year, Group revenues declined to EUR 12.1 million (Q1/2015: EUR 70.4 million). Revenues in the comparable period of 2015 contained a non-recurring effect in the amount of about EUR 59 million from the termination of the partnership with Celgene to co-develop and co-promote MOR202. Success-based payments amounted to 8%, or EUR 1.0 million (Q1/2015: 1%, or EUR 0.5 million), of total revenue. The Proprietary Development segment recorded revenues of EUR 0.1 million (Q1/2015: EUR 59.4 million). Revenues in the Partnered Discovery segment comprised EUR 12.0 million (Q1/2015: EUR 11.0 million).
Total operating expenses for the first three months of 2016 amounted to EUR 21.9 million (Q1/2015: EUR 17.7 million). Total research and development expenses were EUR 18.6 million (Q1/2015: EUR 14.7 million). R&D expenses mainly consisted of costs for external lab services and personnel costs. General and administrative expenses increased slightly to EUR 3.2 million (Q1/2015: EUR 3.0 million) mainly driven by higher expenses for personnel. Earnings before interest and taxes (EBIT) amounted to EUR -9.7 million (Q1/2015: EUR 52.8 million).
The Proprietary Development segment reported a segment EBIT of EUR -14.3 million (Q1/2015: EUR 49.7 million), while Partnered Discovery showed a segment EBIT of EUR 7.7 million (Q1/2015: EUR 5.8 million). Proprietary R&D expenses including technology development amounted to EUR 14.6 million (Q1/2015: EUR 10.4 million).
On March 31, 2016, the Group’s liquidity position amounted to EUR 287.0 million compared to EUR 298.4 million on December 31, 2015. The Company’s liquidity is reflected in the balance sheet items "cash and cash equivalents", "available-for-sale financial assets", "bonds, available-for-sale" and current and non-current "financial assets classified as loans and receivables". The decline in liquidity was mainly the result of the use of cash for operations in the first three months of 2016 and for the repurchase of shares for the Group’s long-term incentive programs.
Financial guidance for 2016
MorphoSys re-confirmed its guidance for 2016. MorphoSys anticipates total Group revenues in the range of EUR 47 million to EUR 52 million and expects EBIT to be in the range of EUR -58 million to EUR -68 million. Proprietary R&D expenses are expected to rise to EUR 76 million to EUR 83 million. This guidance does not include any potential in-licensing or co-development of additional development candidates.