MorphoSys
Written by
MorphoSys |
MOR208 and MOR202 data at ASH |
Pipeline update |
Pharma & biotech |
17 December 2015 |
Share price performance
Business description
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Analysts
MorphoSys is a research client of Edison Investment Research Limited |
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At the American Society of Hematology (ASH) annual meeting, compelling early combination data on MOR208 and MOR202 were presented. MOR208 with lenalidomide in previously untreated chronic lymphocytic leukemia (CLL) patients demonstrated a 100% (four/four) response rate in evaluable patients. In the relapsed/refractory CLL population, the combination demonstrated a 43% (3/7) response rate. MOR202 in combination with lenalidomide or pomalidomide demonstrated a 50% (three/six) response rate in relapsed/refractory multiple myeloma (MM) patients.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/13 |
78.0 |
14.0 |
0.44 |
0.0 |
N/A |
N/A |
12/14 |
64.0 |
(1.6) |
(0.01) |
0.0 |
N/A |
N/A |
12/15e |
104.9 |
23.7 |
0.74 |
0.0 |
N/A |
N/A |
12/16e |
48.5 |
(72.3) |
(1.88) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items and share-based payments.
MOR208 continues to progress
At ASH, MOR208 data in non-Hodgkin’s lymphoma (NHL) and CLL were presented. While the NHL poster was a minor update, the CLL combination data were new and promising, despite the small size of the study. MorphoSys plans to initiate an 80-patient Phase II in combination with lenalidomide in second-line, relapsed/refractory DLBCL patients in Q415. It also plans to initiate a 120-patient Phase II trial in CLL in combination with idelalisib in BTKi-failures in Q116.
MOR202 combination data promising
In the dose escalation portion of a Phase I/IIa study of MOR202 in relapsed/
refractory MM patients, the drug demonstrated a 33% (three/nine) response rate when given once weekly with dexamethasone and a 50% (three/six) response rate when either lenalidomide or pomalidomide was added. The company expects to continue this trial and add further cohorts testing the 16mg/kg dose with both lenalidomide and pomalidomide. A pivotal trial is expected to commence in 2017.
A full pipeline
In total, MorphoSys has 104 programmes (90 partnered, 13 proprietary and one out-licensed) in its pipeline, with 25 (21 partnered, three proprietary and one out-licensed) of these in the clinic. Importantly, two of the partnered programmes, bimagrumab and guselkumab, are expected to have NDA filings in 2016
Valuation: DCF valuation of €1.79bn
We have slightly increased our valuation for MorphoSys to €1.79bn (€67.84 per share) from €1.78bn (€67.24 per share), mainly due to a stronger dollar since our last note somewhat mitigated by a lower cash level. Upcoming catalysts include the initiation of additional MOR208 trials and pivotal trial data for bimagrumab, partnered with Novartis, in sporadic inclusion body myositis in H116.
Additional pipeline data at ASH
At the ASH meeting in Orlando, MorphoSys presented a total of five posters: two on MOR208, its anti-CD19 antibody, and three on MOR202, its anti-CD38 antibody. While some of the data were previously released at conferences, there were compelling new data that demonstrated compelling efficacy when MOR208 and MOR202 are used in combination with lenalidomide or pomalidomide.
MOR208: Compelling data in NHL and CLL
MOR208 is the company’s lead programme and based on data from a 92-patient Phase IIa in multiple subtypes of non-Hodgkin’s lymphoma (NHL), evaluable DLBCL patients exhibited a 36% response rate (see Exhibit 1).
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Exhibit 1: MOR208 response rate in NHL patients |
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Source: ASH 2015, Abstract 1528 |
Importantly, responses have occurred early and have been relatively durable, lasting up to 20.3 months so far (see Exhibit 2).
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Exhibit 2: MOR208 duration of response data in NHL patients |
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Source: ASH 2015, Abstract 1528 |
MorphoSys plans to initiate an 80-patient Phase II in combination with lenalidomide in second-line, relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Q415 and a pivotal study with 320 patients in combination with bendamustine commencing in 2017. Annual incidence of DLBCL is around 26,000 new cases, with around one-third becoming relapsed/refractory to treatment, according to ASH.
With regard to CLL, data were presented from a 16-patient trial of both previously untreated and relapsed/refractory patients with a median of three prior therapies treated with MOR208 in combination with lenalidomide. Of the four evaluable previously untreated patients, 100% responded to the drug. Of those with prior therapies, three out of seven (43%) responded (see Exhibit 3). Importantly, responses tended to improve over time.
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Exhibit 3: MOR208 in combination with lenalidomide in CLL patients |
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Source: ASH 2015, Abstract 2953 |
MorphoSys plans to initiate a 120-patient Phase II trial in combination with idelalisib in BTKi-failures with CLL in Q116. There are an estimated 14,620 new cases of CLL with 4,650 deaths. Our model is currently assuming a 30% chance of success with peak sales of $1.48bn, which assumes 12.5% penetration into the NHL and CLL markets and a $30-45k drug price, which could be conservative given recent trends in oncology drug prices. We await further data before increasing our probability of success, as so far the data in both DLBCL and CLL have been from small samples and the studies have been uncontrolled.
MOR202: More efficacy in combination
MOR202 had promising data presented at the most recent ASCO, EHA and International Myeloma Workshop (IMW) meetings. In an ongoing Phase I/IIa dose-escalation study in MM, 33% of patients receiving clinically relevant doses of MOR202 (4-16mg/kg weekly) were able to achieve a response to therapy. For those with lenalidomide or pomalidomide added to therapy, the response rate increased to 50% (see Exhibit 4).
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Exhibit 4: MOR202 responses in multiple myeloma |
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Source: ASH 2015, Abstract 3035 |
Also, despite this being a heavily pre-treated population (median of four lines of prior therapy in the MOR202 arm, three lines in the arm in combination with pomalidomide and two lines in the arm in combination with lenalidomide), five out of six of the responses are ongoing (see Exhibit 5).
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Exhibit 5: MOR202 duration of response in multiple myeloma |
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Source: ASH 2015, Abstract 3035 |
The question is what type of efficacy is needed to be confident in the success of MOR202. There is quite a bit of data on the use of different regimens (dexamethasone, lenalidomide, pomalidomide, as well as the competing anti-CD38 antibodies daratumumab and SAR650984) in MM available (see Exhibit 6), providing an idea of what the response rate needs to be.
Exhibit 6: Comparison of different regimens in multiple myeloma
Study |
Regimen |
Phase |
Sample Size |
Prior lines |
Response rate |
Lokhorst et al, 2015 |
16mg/kg daratumumab |
I/II |
42 |
4 |
36% |
Lokhorst et al, 2015 |
8mg/kg daratumumab |
I/II |
30 |
4 |
10% |
Weber et al, 2007 |
dexamethasone |
III |
176 |
≥2 |
20% |
Dimopoulos et al, 2007 |
dexamethasone |
III |
175 |
≥2 |
24% |
San Miguel et al, 2013 |
dexamethasone |
III |
153 |
5 |
10% |
Richardson et al, 2009 |
lenalidomide |
II |
222 |
3 |
26% |
Weber et al, 2007 |
lenalidomide + dexamethasone |
III |
177 |
≥2 |
61% |
Dimopoulos et al, 2007 |
lenalidomide + dexamethasone |
III |
176 |
≥2 |
60% |
Richardson et al, 2014 |
pomalidomide |
II |
108 |
5 |
18% |
Lacy et al, 2009 |
pomalidomide + dexamethasone |
II |
60 |
2 |
63% |
Leleu et al, 2013 |
pomalidomide + dexamethasone |
II |
43 |
5 |
35% |
Richardson et al, 2014 |
pomalidomide + dexamethasone |
II |
113 |
5 |
33% |
San Miguel et al, 2013 |
pomalidomide + dexamethasone |
III |
302 |
5 |
31% |
Martin et al, 2014 |
SAR650984 |
I |
30 |
6.5 |
27% |
Raab et al, 2015 |
4-16mg/kg MOR202 + dexamethasone |
I/IIa |
9 |
4 |
33% |
Raab et al, 2015 |
8mg/kg MOR202 + dexamethasone + lenalidomide |
I/IIa |
3 |
2 |
33% |
Raab et al, 2015 |
8mg/kg MOR202 + dexamethasone + pomalidomide |
I/IIa |
3 |
3 |
67% |
Source: Nooka et al, 2015. Treatment options for relapsed and refractory multiple myeloma. Blood 2015 125: 3085-3099. ASH 2015, ASH 2014, Lokhorst et al, 2015. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. NEJM 2015; 373:1207-1219
One major caveat to any comparison is that the MOR202 trial is still in the dose-ranging phase and it appears that full target occupancy occurs at the 16mg/kg level for MOR202 (though saturation begins to be seen at the 8mg/kg level) when given once a week, so doses below that level are likely suboptimal. Based on the data so far, only two patients have received this optimal level of therapy. There will be additional cohorts of MOR202 at the 16mg/kg level in combination with both pomalidomide and lenalidomide that will be evaluated and we expect additional updates on those over the course of 2016.
MOR202 also has a best-in-class infusion tolerability profile, with only 6% of patients having mild infusion reactions when treated with MOR202 + dexamethasone. The competitive products have c 50% of patients reporting infusion reactions despite mandatory co-medication with steroids and, in the case of daratumumab, the initial dose is infused over eight hours to limit the infusion reactions, whereas MOR202 takes only two hours to infuse.
Our model is currently assuming a 30% chance of success with peak sales of $883m, which assumes 20% penetration into the MM markets and a $30-45k drug price, which could be conservative given recent trends in oncology drug prices. We await further data at the optimal doses before increasing our probability of success.
Valuation
We have slightly increased our valuation for MorphoSys to €1.79bn (€67.84 per share) from €1.78bn (€67.24 per share), mainly due to a stronger dollar since our last note somewhat mitigated by a lower net cash level. Upcoming catalysts include the initiation of additional MOR208 trials and pivotal trial data for bimagrumab, partnered with Novartis, in sporadic inclusion body myositis in H116.
Exhibit 7: Valuation of MorphoSys
Value driver (indication) |
Launch date |
Peak sales |
Likelihood of success |
Royalty/margin |
Value (€m) |
Value per |
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Partnered discovery |
138.7 |
5.24 |
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MOR103 royalties (RA) |
2021 |
$2.69bn |
40% |
15% |
236.1 |
8.92 |
|
MOR103 royalties (MS) |
2021 |
$1.50bn |
15% |
15% |
65.2 |
2.47 |
|
MOR103 milestones |
Risk-adjusted milestones: €20m in 2015, €50m in 2016, €50m in 2017, €150m in 2018, €50m in 2019. |
67.5 |
2.55 |
||||
MOR202 royalties ex-Europe (MM) |
2019 |
$480m |
30% |
22.5% |
66.9 |
2.53 |
|
MOR202 profits in Europe (MM) |
2019 |
$400m |
30% |
35% |
86.4 |
3.27 |
|
MOR202 milestones |
Risk-adjusted milestones: $50m in 2016, $25m in 2018, $75m in 2019. |
39.8 |
1.51 |
||||
MOR208 royalties ex-Europe |
2019 |
$675m |
30% |
22.5% |
118.3 |
4.47 |
|
MOR208 profits in Europe |
2019 |
$805m |
30% |
32.5% |
203.9 |
7.71 |
|
MOR209 royalties in US (CRPC) |
2022 |
$440m |
15% |
15% |
13.6 |
0.51 |
|
MOR209 profits in Europe (CRPC) |
2022 |
$490m |
15% |
35% |
37.7 |
1.43 |
|
MOR209 milestones |
Risk-adjusted milestones to Emergent Biosolutions: €10m in 2018, €50m in 2016, €30m in 2021, €40m in 2022. |
(5.5) |
(0.21) |
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Gantenerumab* royalties (AD) |
2019 |
$3.52bn |
20% |
5.5-7% |
100.9 |
3.81 |
|
Bimagrumab* royalties (cachexia) |
2017 |
$1.20bn |
60% |
5% |
93.2 |
3.52 |
|
Guselkumab* royalties (psoriasis) |
2017 |
$1.75bn |
50% |
5% |
107.2 |
4.05 |
|
CNTO6785* royalties (RA) |
2019 |
$1.35bn |
30% |
5% |
39.4 |
1.49 |
|
LFG316* royalties (AMD) |
2018 |
$875m |
30% |
5% |
34.1 |
1.29 |
|
CNTO3157* royalties (asthma) |
2019 |
$740m |
30% |
5% |
21.6 |
0.82 |
|
Tarextumab* royalties (cancer) |
2017 |
$750m |
30% |
5% |
29.2 |
1.10 |
|
VAY736* royalties (autoimmune diseases) |
2019 |
$750m |
30% |
5% |
21.9 |
0.83 |
|
LJM716* royalties (cancer) |
2019 |
$750m |
30% |
5% |
21.9 |
0.83 |
|
BHQ880* royalties (MM) |
2018 |
$540m |
15% |
5% |
8.8 |
0.33 |
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Other royalties - |
2018-21 |
$750m per product |
10% |
5% |
66.9 |
2.53 |
|
Cost of proprietary drug discovery |
Risk-adjusted DCF valuation of cash flows until 2021; WACC: 12.5%. |
(129.6) |
(4.90) |
||||
Unallocated costs |
DCF valuation of cash flows until 2021; WACC: 12.5%. |
(22.9) |
(0.86) |
||||
Other |
Grants, capital expenditure, depreciation, and changes in working capital. |
30.3 |
1.14 |
||||
Net cash at Q315 |
303.5 |
11.47 |
|||||
Total |
1,794.9 |
67.84 |
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Source: Edison Investment Research. Note: *Non-proprietary products. WACC of 12.5% was used on all potential product royalties. Tax rate = 30%.
Financials
At its Q315 results, MorphoSys reconfirmed its guidance for the year of revenues of €101-106m, with €56-63m in proprietary R&D expenses (which does not include R&D related to partner discovery) and €9-16m worth of EBIT. Due to the more aggressive focus on its internal pipeline, proprietary R&D expenses are likely to be much higher in 2016 than they will be for 2015, although we are not likely to receive clarity on the extent of the increase until early 2016.
The issue for the company is that by the end of 2017, its Novartis discovery collaboration may end (although Novartis has an option to extend it by two years). As this collaboration provides MorphoSys with €40m in annual funding, the end of this collaboration, coupled with a more aggressive R&D strategy, could accelerate the timeline for the next capital raise. However, bimagrumab, partnered with Novartis for sporadic inclusion body myositis (sIBM), and guselkumab, partnered with Johnson & Johnson for psoriasis, are expected to be filed for approval in 2016 and could therefore start to provide MorphoSys with mid-single digit royalties starting in 2017. Adding in potential upfront payments from future collaborations (especially for MOR208 and MOR202), these royalties may more than make up for any lost revenue from Novartis and may delay any cash shortfall and the need for additional capital.
Exhibit 8: Financial summary
2013 |
2014 |
2015e |
2016e |
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Year end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
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PROFIT & LOSS |
||||||
Revenue |
|
|
77,960 |
63,978 |
104,875 |
48,482 |
Cost of Sales |
0 |
0 |
0 |
0 |
||
Gross Profit |
77,960 |
63,978 |
104,875 |
48,482 |
||
R&D Expenses |
(49,152) |
(55,963) |
(75,449) |
(112,721) |
||
Sales, General and Administrative Expenses |
(18,770) |
(14,146) |
(14,427) |
(14,718) |
||
EBITDA |
|
|
18,050 |
(1,764) |
23,748 |
(72,606) |
Operating Profit (before GW and except.) |
|
13,216 |
(3,211) |
21,041 |
(73,175) |
|
Intangible Amortisation |
(3,291) |
(2,688) |
(1,452) |
(5,559) |
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Exceptionals/Other |
0 |
0 |
0 |
0 |
||
Operating Profit |
9,925 |
(5,899) |
19,589 |
(78,734) |
||
Net Interest |
756 |
1,590 |
2,635 |
861 |
||
Exceptionals/Other |
0 |
0 |
0 |
0 |
||
Profit Before Tax (norm) |
|
|
13,972 |
(1,621) |
23,676 |
(72,315) |
Profit Before Tax (FRS 3) |
|
|
10,681 |
(4,309) |
22,224 |
(77,873) |
Tax |
(3,310) |
1,296 |
(4,364) |
23,362 |
||
Discontinued operations |
5,951 |
0 |
0 |
0 |
||
Profit After Tax (norm) |
10,662 |
(325) |
19,312 |
(48,953) |
||
Profit After Tax (FRS 3) |
13,322 |
(3,013) |
17,860 |
(54,511) |
||
Average Number of Shares Outstanding (m) |
24.5 |
25.9 |
26.0 |
26.0 |
||
EPS - normalised (c) |
|
|
43.5 |
(1.3) |
74.4 |
(188.0) |
EPS - FRS 3 (c) |
|
|
54.4 |
(11.6) |
68.8 |
(209.3) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
||
Gross Margin (%) |
100.0 |
100.0 |
100.0 |
100.0 |
||
EBITDA Margin (%) |
23.2 |
N/A |
N/A |
N/A |
||
Operating Margin (before GW and except.) (%) |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
||||||
Fixed Assets |
|
|
41,089 |
104,083 |
101,057 |
96,626 |
Intangible Assets |
35,150 |
45,980 |
82,369 |
77,537 |
||
Tangible Assets |
2,168 |
3,558 |
3,643 |
4,043 |
||
Other |
3,772 |
54,545 |
15,045 |
15,045 |
||
Current Assets |
|
|
406,567 |
322,395 |
311,834 |
247,505 |
Stocks |
731 |
556 |
529 |
529 |
||
Debtors |
10,270 |
14,991 |
22,986 |
10,626 |
||
Cash |
271,336 |
145,766 |
111,775 |
36,445 |
||
Other |
124,230 |
161,083 |
176,543 |
199,905 |
||
Current Liabilities |
|
|
(35,407) |
(32,703) |
(36,375) |
(18,435) |
Creditors |
(17,190) |
(17,831) |
(29,365) |
(13,575) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
||
Deferred revenues |
(15,267) |
(14,075) |
(4,166) |
(4,196) |
||
Other short term liabilities |
(2,950) |
(797) |
(2,844) |
(664) |
||
Long Term Liabilities |
|
|
(60,104) |
(44,972) |
(11,240) |
(11,268) |
Long term borrowings |
(299) |
(252) |
(244) |
(244) |
||
Deferred revenues |
(59,169) |
(44,677) |
(3,828) |
(3,856) |
||
Other long term liabilities |
(637) |
(43) |
(7,168) |
(7,168) |
||
Net Assets |
|
|
352,145 |
348,803 |
365,276 |
314,427 |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
90,374 |
(11,921) |
(24,741) |
(72,313) |
Net Interest |
143 |
645 |
341 |
861 |
||
Tax |
(1,380) |
(2,942) |
(4,542) |
(2,180) |
||
Capex |
(5,558) |
(20,474) |
(8,606) |
(1,697) |
||
Acquisitions/disposals |
36,580 |
0 |
0 |
0 |
||
Financing |
132,725 |
(3,919) |
(24,389) |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
(2,324) |
0 |
370 |
0 |
||
Net Cash Flow |
250,561 |
(38,611) |
(61,568) |
(75,330) |
||
Opening net debt/(cash) |
|
|
(130,338) |
(390,496) |
(352,548) |
(296,949) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
||
Exchange rate movements |
4 |
(1) |
(0) |
0 |
||
Other |
9,592 |
664 |
5,969 |
0 |
||
Closing net debt/(cash) |
|
|
(390,496) |
(352,548) |
(296,949) |
(221,619) |
Source: Edison Investment Research, company reports
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