At JPM, MorphoSys’ (MOR) presentation focused heavily on its most advanced proprietary
program MOR208, an Fc-enhanced anti-CD19 antibody. L-MIND is a pivotal Phase II trial
evaluating MOR208 combined with lenalidomide in relapsed/refractory DLBCL. Dr. Moroney,
MorphoSys’ CEO, explained that MOR208 attracts NK cells to the tumor while lenalidomide helps
activate them. Interim data from L-MIND has been impressive (33% CR rate and 16.2 months
median PFS) and final results are expected in Q2 2019. A rolling BLA submission is expected to be
complete by Q4 2019 and an approval is expected by mid-2020. A confirmatory Phase II/III trial,
B-MIND, comparing MOR208/bendamustine to rituximab/bendamustine is ongoing with top-line
results expected in late 2019 and primary completion in early 2020. With approximately 28,000
new DLBCL cases in the US every year, MorphoSys estimates that the initial addressable US
market for relapsed/refractory DLBCL is 8,500 patients/year.
Preclinical data has shown synergy between MOR208 and rituximab. A Phase Ib trial evaluating
MOR208 + R-CHOP vs MOR208 + lenalidomide + R-CHOP in treatment naïve DLBCL is expected to
initiate in Q3 2019. If the results are good, a pivotal Phase II/III trial could initiate in mid-2020.
MOR208 is also being developed for other indications.
An anti-CD38 antibody, MOR202, is no longer being developed for multiple myeloma in the US
but MorphoSys is suing Jannsen saying that Darzalex infringes on three of its patents and the trial
is expected to start in February 2019. I-Mab has received exclusive development and
commercialization rights in China, Taiwan, Hong Kong and Macao. MorphoSys received an
upfront payment of $20 million, up to $100 million in milestones and tiered double-digit royalties.
I-Mab plans to start a pivotal Chinese study of MOR202 in multiple myeloma in Q1 2019. Finally,
MorphoSys plans to develop MOR202 in the US for an autoimmune indication with a Phase II
study expected to initiate in Q3 2019.
MOR106, a first-in-class anti-IL-17C antibody was co-developed with Galapagos and was fully outlicensed to Novartis in July 2018 for EUR 95 million upfront, milestone payments of up to EUR 850
million and tiered royalties (low teens to low twenties). All payments are shared with Galapagos
50/50. MOR106 reported encouraging results in a placebo-controlled Phase I trial in atopic
dermatitis. Morphosys and Galapagos will complete by Q3 2019 (i) IGUANA, an ongoing Phase II
trial in ~240 patients with moderate to severe atopic dermatitis and (ii) a bridging study with a
subcutaneous formulation. Development of a subcutaneous formulation is essential for a viable
atopic dermatitis product. Morphosys and Galapagos have committed to initiating additional
trials in atopic dermatitis while Novartis has committed to carrying out Phase II studies in two
other indications as well as responsibility for all late Phase trials.
Tremfya, an anti-IL-23 antibody approved for psoriasis and licensed to Janssen, saw Q3 2018 sales
increase by 36% compared to Q2 2018. Royalty income for 2018 is now expected to be at the
upper end of guidance (EUR 12 to 17 million). Tremfya continues to be developed for additional
indications.
Group revenues for FY2018 are expected to reach EUR 68-72 million while expenses are expected
to be EUR 87-97 million for an EBIT loss of EUR 55 to 65 million. At the end of Q3 2018, the
company had EUR 481.2 million in cash and total ordinary shares issued as of December 31, 2018
was 31,839,572.
As MorphoSys continues to advance MOR208 to regulatory approval it is building US commercial
capabilities for an anticipated 2020 launch.
program MOR208, an Fc-enhanced anti-CD19 antibody. L-MIND is a pivotal Phase II trial
evaluating MOR208 combined with lenalidomide in relapsed/refractory DLBCL. Dr. Moroney,
MorphoSys’ CEO, explained that MOR208 attracts NK cells to the tumor while lenalidomide helps
activate them. Interim data from L-MIND has been impressive (33% CR rate and 16.2 months
median PFS) and final results are expected in Q2 2019. A rolling BLA submission is expected to be
complete by Q4 2019 and an approval is expected by mid-2020. A confirmatory Phase II/III trial,
B-MIND, comparing MOR208/bendamustine to rituximab/bendamustine is ongoing with top-line
results expected in late 2019 and primary completion in early 2020. With approximately 28,000
new DLBCL cases in the US every year, MorphoSys estimates that the initial addressable US
market for relapsed/refractory DLBCL is 8,500 patients/year.
Preclinical data has shown synergy between MOR208 and rituximab. A Phase Ib trial evaluating
MOR208 + R-CHOP vs MOR208 + lenalidomide + R-CHOP in treatment naïve DLBCL is expected to
initiate in Q3 2019. If the results are good, a pivotal Phase II/III trial could initiate in mid-2020.
MOR208 is also being developed for other indications.
An anti-CD38 antibody, MOR202, is no longer being developed for multiple myeloma in the US
but MorphoSys is suing Jannsen saying that Darzalex infringes on three of its patents and the trial
is expected to start in February 2019. I-Mab has received exclusive development and
commercialization rights in China, Taiwan, Hong Kong and Macao. MorphoSys received an
upfront payment of $20 million, up to $100 million in milestones and tiered double-digit royalties.
I-Mab plans to start a pivotal Chinese study of MOR202 in multiple myeloma in Q1 2019. Finally,
MorphoSys plans to develop MOR202 in the US for an autoimmune indication with a Phase II
study expected to initiate in Q3 2019.
MOR106, a first-in-class anti-IL-17C antibody was co-developed with Galapagos and was fully outlicensed to Novartis in July 2018 for EUR 95 million upfront, milestone payments of up to EUR 850
million and tiered royalties (low teens to low twenties). All payments are shared with Galapagos
50/50. MOR106 reported encouraging results in a placebo-controlled Phase I trial in atopic
dermatitis. Morphosys and Galapagos will complete by Q3 2019 (i) IGUANA, an ongoing Phase II
trial in ~240 patients with moderate to severe atopic dermatitis and (ii) a bridging study with a
subcutaneous formulation. Development of a subcutaneous formulation is essential for a viable
atopic dermatitis product. Morphosys and Galapagos have committed to initiating additional
trials in atopic dermatitis while Novartis has committed to carrying out Phase II studies in two
other indications as well as responsibility for all late Phase trials.
Tremfya, an anti-IL-23 antibody approved for psoriasis and licensed to Janssen, saw Q3 2018 sales
increase by 36% compared to Q2 2018. Royalty income for 2018 is now expected to be at the
upper end of guidance (EUR 12 to 17 million). Tremfya continues to be developed for additional
indications.
Group revenues for FY2018 are expected to reach EUR 68-72 million while expenses are expected
to be EUR 87-97 million for an EBIT loss of EUR 55 to 65 million. At the end of Q3 2018, the
company had EUR 481.2 million in cash and total ordinary shares issued as of December 31, 2018
was 31,839,572.
As MorphoSys continues to advance MOR208 to regulatory approval it is building US commercial
capabilities for an anticipated 2020 launch.
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