MorphoSys — Update 16 December 2015

MorphoSys — Update 16 December 2015

MorphoSys

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MorphoSys

MOR208 and MOR202 data at ASH

Pipeline update

Pharma & biotech

17 December 2015

Price

€56.16

Market cap

€1,488m

€/US$1.09

Net cash (€m) at 30 September 2015

303.5

Shares in issue

26.5m

Free float

92%

Code

MOR

Primary exchange

Frankfurt

Secondary exchange

OTC

Share price performance

%

1m

3m

12m

Abs

1.3

(10.3)

(32.8)

Rel (local)

3.7

(12.3)

(38.6)

52-week high/low

€86.80

€52.95

Business description

MorphoSys is a German biotechnology company. It uses its proprietary technologies to develop human antibodies and peptides for therapeutic use and has 25 antibodies in its clinical pipeline. Its lead proprietary R&D programmes are MOR208 for DLBCL and CLL, as well as MOR202 for MM.

Next events

Bimagrumab pivotal data

Early 2016

MOR209 Phase I data

2016

Guselkumab data from three pivotal trials

2016

Analysts

Maxim Jacobs

+1 646 653 7027

Christian Glennie

+44 (0)20 3077 5727

MorphoSys is a research client of Edison Investment Research Limited

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*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

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).

Exhibit 1: MOR208 response rate in NHL patients

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).

Exhibit 2: MOR208 duration of response data in NHL patients

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.

Exhibit 3: MOR208 in combination with lenalidomide in CLL patients

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).

Exhibit 4: MOR202 responses in multiple myeloma

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).

Exhibit 5: MOR202 duration of response in multiple myeloma

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
share (€)

Partnered discovery

138.7

5.24

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
(CLL, ALL, NHL)

2019

$675m

30%

22.5%

118.3

4.47

MOR208 profits in Europe
(CLL, ALL, NHL)

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)

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

Other royalties -
OMP-18R5*, BI 836845*, PFE-1*, and BAY 94-9343*, NOV-7*, NOV-8*, NOV-9, NOV-10, NOV-11, BPS-804

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

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

Year end 31 December

IFRS

IFRS

IFRS

IFRS

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)

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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Henderson International Income Trust

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