On November 7, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported its financial results for the first nine months of 2016, and outlined the key events for the third quarter ending September 30, 2016 (Press release, MorphoSys, NOV 6, 2016, View Source [SID1234516664]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Financial results for the first nine months of 2016
For first nine months of 2016, group revenues totaled EUR 36.7 million and EBIT amounted to EUR -32.3 million. Previous year’s figures included a non-recurring effect of approximately EUR 59 million (9-months 2015 revenues: EUR 93.9 million; 9-months 2015 EBIT: EUR 34.7 million).
Adjusted for last year’s one-off effect, 9-months group revenues rose by 5% year-on-year.
The Group’s liquidity position on September 30, 2016 amounted to EUR 267.2 million (December 31, 2015: EUR 298.4 million).
The Company confirms its 2016 guidance for revenues in the range of EUR 47 million to EUR 52 million and EBIT between EUR -58 million and EUR -68 million.
Operating highlights of the third quarter of 2016
In early August, MorphoSys announced the successful completion of the safety run-in of its phase 2 clinical trial of MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) (L-MIND trial).
At the beginning of September, MorphoSys disclosed that the first patient had been dosed in the safety run-in of a phase 2/3 combination trial of MOR208 with bendamustine. The B-MIND trial will evaluate the safety and efficacy of MOR208 combined with the chemotherapeutic agent bendamustine in comparison to rituximab plus bendamustine. The study is expected to transition into a pivotal phase 3 part in 2017.
At the end of September, MorphoSys and its Belgian development partner Galapagos NV announced that the first patient with atopic dermatitis was dosed in an ongoing phase 1 trial of MOR106 against IL-17C after the antibody showed favorable safety in healthy volunteers.
In early July, MorphoSys disclosed the receipt of a milestone payment from Novartis, which was recognized in the second quarter of 2016. This payment was triggered by the initiation of a phase 1 clinical study of a novel HuCAL antibody for the prevention of thrombosis.
In September, the Company announced the appointment of four experts to its newly formed Scientific Advisory Board. This international panel of scientific experts was established to advise the Company on the strategic options and future perspectives within its research and development activities.
In September, MorphoSys’s Dutch subsidiary Lanthio Pharma B.V., which specializes in the development of lanthipeptides, announced the appointment of Axel Mescheder, M.D. as its Chief Medical Officer.
In mid-October, the Company announced the receipt of a milestone payment from Novartis, which was booked in the third quarter of 2016. The payment was triggered by the start of a phase 1 clinical trial with a novel HuCAL antibody in the field of cancer.
At the end of the third quarter, MorphoSys’s pipeline comprised an all-time high of 110 therapeutic programs, 28 of which are in clinical development.
Key events after the end of the third quarter of 2016
On October 1, 2016, MorphoSys announced that its licensee Janssen Research & Development, LLC (Janssen) reported positive results from a phase 3 clinical study of guselkumab in 837 patients with moderate to severe plaque psoriasis ("VOYAGE 1" study). Guselkumab is a fully human antibody targeting IL-23 which was selected from MorphoSys’s HuCAL antibody library. According to Janssen, both co-primary endpoints were met. Janssen also reported that all major secondary endpoints achieved statistical significance in comparisons of guselkumab versus adalimumab (Humira). Following the positive study results, Janssen announced plans to apply for regulatory approval in 2016. Guselkumab is expected to be the first HuCAL antibody to reach the market.
In EURO million* 9-Months 2016 9-Months 2015
Group Revenues 36.7 93.9
Total Operating Expenses 69.1 63.6
Other Income/Expenses 0.1 4.5
Earnings Before Interest and Taxes – EBIT (32.3) 34.7
Consolidated Net Profit / (Loss) (31.6) 28.2
Total EPS, diluted, in EURO (1.21) 1.07
* Differences due to rounding
"We are excited about the phase 3 data in moderate-to-severe psoriasis that our partner Janssen has generated with guselkumab. This could become the first product based on our proprietary technology to reach the market," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Our therapeutic pipeline is progressing well, now with 110 programs in development, more than ever before, of which 28 are in clinical studies."
"With the results shown for the first nine months of 2016 we are on track to meet our targets for the full year," stated Jens Holstein, Chief Financial Officer of MorphoSys AG. "Based on our solid financial situation with liquidity of EUR 267.2 million at the end of the third quarter, MorphoSys will continue to invest in our promising development candidates from a position of strength."
Financial Review of the First Nine Months of 2016 (IFRS)
Group revenues in the first nine months of 2016 amounted to EUR 36.7 million, compared to EUR 93.9 million in the first nine months of 2015. The main reason for the decline compared to the previous year period is a non-recurring effect of about EUR 59 million in 2015 in connection with the termination of the collaboration with Celgene for MOR202. Adjusted for last year’s one-off effect, revenues for the first nine months rose by 5%.
The Proprietary Development segment recorded revenues of EUR 0.5 million (9-months 2015: EUR 59.9 million). Revenues in the Partnered Discovery segment reached EUR 36.2 million (9-months 2015: EUR 34.0 million). Success-based payments amounted to about 10% of total revenues, or EUR 3.5 million (9-months 2015: 3% or EUR 2.5 million).
Total operating expenses for the first nine months of 2016 amounted to EUR 69.1 million (9-months 2015: EUR 63.6 million). Total research and development expenses were EUR 58.8 million (9-months 2015: EUR 53.1 million). The increase is mainly due to intensified clinical development activities with MorphoSys’s proprietary antibody candidates, in particular the start of two phase 2 trials with MOR208 in 2016. R&D expenses mainly consisted of costs for external laboratory services and personnel costs. General and administrative expenses decreased slightly to EUR 10.3 million (9-months 2015: EUR 10.6 million).
Earnings before interest and taxes (EBIT) amounted to EUR -32.3 million (9-months 2015: EUR 34.7 million). Adjusted for the one-off effect in 2015 amounting to EUR 59 million, the operating loss (EBIT) for the first nine months rose by 33%, mainly due to the increase in R&D activities.
The Proprietary Development segment reported a segment EBIT of EUR -45.5 million (9-months 2015: EUR 26.5 million), while Partnered Discovery showed a nine months segment EBIT of EUR 22.8 million (9-months 2015: EUR 18.1 million). Proprietary R&D expenses including technology development amounted to EUR 46.2 million, the comparative figure for 9-months 2015 was EUR 39.9 million.
On September 30, 2016, the Group’s liquidity position amounted to EUR 267.2 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 nine months of 2016 and the repurchase of shares for the Group’s long-term incentive program.
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.