Erytech Pharma — Update 29 July 2016

Erytech Pharma — Update 29 July 2016

Erytech Pharma

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Erytech Pharma

Dense newsflow during next 12 months

Company update

Pharma & biotech

29 July 2016

Price

€20.25

Market cap

€160m

Estimated net cash (€m) at end Q116

39.9

Shares in issue

7.9m

Free float

70%

Code

ERYP

Primary exchange

Euronext

Secondary exchange

OTC US

Share price performance

%

1m

3m

12m

Abs

6.5

(20.1)

(41.1)

Rel (local)

(1.7)

(17.8)

(34.2)

52-week high/low

€40.0

€18.2

Business description

Erytech is a French oncology company with a red blood cell encapsulation technology. Lead product Graspa has successfully completed a Phase III ALL trial and a Phase IIb in AML is ongoing, in addition to a Phase II in pancreatic cancer. Graspa is partnered with Orphan Europe/Recordati in Europe.

Next events

US Phase I ALL data

H216

Start of NHL Phase II study

H216

Pancreatic cancer Phase II data

Q416

Graspa ALL European approval decision

End-2016/
early 2017

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Lala Gregorek

+44 (0)20 3681 2527

Erytech Pharma is a research client of Edison Investment Research Limited

Erytech’s lead indication, acute lymphocytic leukaemia (ALL), is being explored in a comprehensive programme for its Graspa technology, with acute myeloid leukemia (AML) and pancreatic cancer following next. Key clinical data are expected for all three indications during the next 12 months, with the hallmark event being expected approval of the marketing application for Graspa for relapsed/refractory ALL in Europe by end-2016/early 2017. Our valuation of Erytech remains largely unchanged at €322m.

Year
end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/14

2.0

(9.0)

(1.51)

0.0

N/A

N/A

12/15

2.9

(15.0)

(2.16)

0.0

N/A

N/A

12/16e

2.8

(18.8)

(2.35)

0.0

N/A

N/A

12/17e

2.9

(20.2)

(2.49)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items.

Key catalysts to mid-2017

With Graspa already filed in Europe in relapsed/refractory ALL and a decision expected by end-2016, the focus is now on the US and new indications. A Phase Ib study in ALL in the US is ongoing with data expected in 2016. This could potentially allow rolling out development into front-line ALL globally. A Phase IIb trial in AML is more than 90% recruited, with primary results expected in mid-2017. A Phase II trial in pancreatic cancer is the first solid tumour indication and results should be released in Q416.

Supportive immuno-oncology preclinical data

Erytech believes it can expand the use of its technology to develop cancer vaccines. Recently, it revealed supportive preclinical data, which concluded that immunisation with erythrocytes loaded with tumour-specific antigens induces an efficient immune response against tumour. The results were consistent across different cancer cell lines (three types tested) and the approach could be used as a cancer immunotherapy. This is still a preclinical-stage effort, but with potential for a rapid progression, in our view, given the attention to immuno-oncology in the industry.

Valuation: rNPV of €322m or €41/share

Our rNPV-based valuation remains largely unchanged at €321.8m (€324.9m previously) or €40.5/share. Main changes to our model include a delayed estimated launch date for Graspa/ERY-ASP in AML, a lower estimated net cash position at Q116 and somewhat increased R&D cost estimates (see financials), partly offset by an earlier launch date for Graspa/ERY-ASP in pancreatic cancer and rolling our model forward. The upcoming dense newsflow will provide value inflection opportunities.

Key catalysts in H216

In December 2015 Erytech carried out a second successful private placement since the IPO in April 2013, raising gross proceeds of €25.4m. The company’s ability to attract fresh capital underpins healthy progress with the R&D pipeline. The table below summarises Erytech’s key assets and newsflow, with at least four catalysts coming in the next 12-18 months.

Exhibit 1: Erytech’s pipeline

Product

Indication

Stage

Comments

Graspa/ERY-ASP

ALL

Phase III complete

Europe: marketing application submitted in September 215; approval expected end-2016/early 2017.

US: Phase I ALL confirmatory safety trial ongoing, expected to be completed this year.

Graspa/ERY-ASP

AML

Phase IIb

Europe: more than 90% recruited; three DSMBs complete; primary results are expected in mid-2017.
Funded by partner Recordati.

Graspa/ERY-ASP

NHL (NK/T-cell lymphoma)

Phase II

Erytech planning to start Phase II development in 2016.

Graspa/ERY-ASP

Pancreatic cancer

Phase II

Original recruitment objective reached; DSMB complete; results expected in Q416.

Other solid tumours

50-90% of solid tumours could be eligible.

ERY-MET, ERY-ADI

Cancer

Preclinical

ERY-MET is encapsulated methionine gamma-lyase (MGL) and Phase I could start in 2016;
ERY-ADI is encapsulated arginine-deiminase (ADI) and Phase I could start in 2017.

ERYMMUNE

Cancer immunotherapy

Preclinical

Antigen carrying RBCs. Preclinical proof-of-concept data obtained in three different tumour models; preclinical development to continue.

ERY-ERT

ERT enhancement

Preclinical

Prolonging the half-life of enzyme replacement therapy (ERT).

Source: Edison Investment Research. Note: Natural Killer (NK) T-cell lymphoma is an aggressive form of non-Hodgkin lymphoma. Graspa is a brand name in Europe and Israel, ERY-ASP elsewhere.

Executing on strategy in ALL

Erytech’s core strategy is to reach the market as quickly as possible by developing its lead product, Graspa (brand name in Europe and Israel, ERY-ASP elsewhere), for relatively easy-to-penetrate target populations and then to expand in two directions: label/indication expansion and new products using its erythrocyte encapsulation technology.

ALL is the lead indication for Graspa, with a marketing authorisation application (MAA) already submitted to the European Medicines Agency (EMA). Erytech has a comprehensive programme to broaden the label for Graspa moving from the most difficult relapsed/refractory ALL patients to first-line treatment. Near term plans include two ongoing trials and another three pivotal trials.

EU approval for relapsed/refractory ALL patients is the first step

The main basis for the European MAA filing is the data from the Phase II/III trial of Graspa versus native L-asparaginase in children and adult ALL patients who relapsed on previous asparaginase treatment. The trial was completed in 2014, with the results described in our previous reports. Initially, a better safety profile and non-inferior efficacy compared to native L-asparaginase were the key objectives for Graspa. As a reminder:

the Phase II/III trial demonstrated that Graspa was superior to native L-asparaginase in terms of safety, with no allergic reactions on Graspa vs 46% on native L-asparaginase (p<0.001); and

the trial had a significantly longer duration of activity (an efficacy surrogate), with 20.5 days for Graspa compared to 9.6 days for native L-asparaginase (p<0.001).

Although these results alone are likely to be sufficient for approval by the EMA, maturing Phase II/III data look beyond expectations. Two-year follow-up data were presented during the annual meeting of the American Society of Hematology (ASH) in December 2015. Median event-free survival was 11.8 months in the native L-asparaginase arm, but had not been reached in the Graspa arm after two years. Median overall survival was not reached in either of the treatment arms. This highlights Graspa’s potential to improve outcomes for patients without L-asparaginase tolerability issues.

ALL label expansion to first-line treatment and US development plans

Label expansion and FDA approval are the next steps to broaden access to the ALL population (Exhibit 2).

Currently, Erytech runs the Expanded Access Program (EAP) in France, which could be extended to a global pivotal study in patients who are allergic to both the existing forms of L-asparaginase (‘double allergic’ patients). Given the unmet need, this ultra-orphan indication could provide an expedited route to market in the US, with potential approval in 2018.

A Phase I study in first-line treatment of adults is ongoing in the US and should be completed this year. A subsequent Phase II trial could allow for registration in the US and a label expansion in Europe. Adults typically do not tolerate and are rarely treated with native L-asparaginase treatment, although it could be effective. These patients therefore represent a virtually untapped target population that could be accessed if trial results are positive.

Erytech is also planning a global Phase III study as first-line treatment in children. The trial would support label expansions in the US and Europe and could broaden Graspa’s potential to compete directly with existing L-asparaginase treatments.

Exhibit 2: Erytech’s strategy for label extension in ALL

Source: Erytech Pharma

Expansion into other indications and new product development

According to the latest update provided during the Q116 results call, the trials for other indications are progressing according to plan. A European Phase IIb for AML, funded by partner Recordati, is on track to complete enrolment in 2016, with preliminary results expected in mid-2017. The third safety assessment by DSMB at the end of 2015 raised no issues and recommended continuing the trial. Previously, Erytech indicated that this study could be sufficient to gain approval in Europe. Hence, if results are published in 2017, this could allow for potential approval in 2018. With AML affecting around 40,000 patients in the EU and US, this could be a much larger market than ALL (c 16,000 in 2015), including the fact that the disease primarily affects elderly patients who do not tolerate L-asparaginase.

Exhibit 3: Erytech’s clinical-stage projects

Source: Erytech Pharma. Note: Erytech also has other tumour starvation, enzyme replacement and immune-oncology projects in various preclinical stages.

Asparagine depletion can also be an effective approach in addressing solid tumours, as demonstrated by the collaboration with the MD Anderson Cancer Center in the US, which discovered that there are a large number of solid tumours which also require asparagine, but express low levels of asparagine synthetase (ASNS). Low ASNS-expressing tumours cells could therefore be sensitive to L-asparaginase treatment although, due to the toxicity of native L-asparaginase, this treatment has had limited use to date. Erytech’s Phase II study for pancreatic cancer is the first step in addressing solid tumours and, if successful, the results could serve as a proof-of-concept, not only for pancreatic cancer, but also for low ASNS-expressing solid tumours in general. The enrolment has recently reached its original goal of 90 patients, but the company elected to continue with the aim of increasing the statistical power of the study. Preliminary results are expected in Q416.

More data from preclinical development in immuno-oncology

Erytech believes it can expand the use of its technology to develop cancer vaccines. This is still a preclinical-stage effort, but with potential for rapid progression, in our view, given the focus on immuno-oncology in the industry. According to this approach, red blood cells are loaded with tumour-specific antigens and injected intravenously (much like the lead product Graspa, which comprises erythrocytes loaded with L-asparaginase). The membranes of the erythrocytes are also coated with specific antibodies to make them target immune system cells called antigen-presenting cells or dendritic cells, which absorb them and incorporate the tumour antigens. A natural immune system response follows – dendritic cells present the tumour antigens to other lymphocytes, which then turn into cytotoxic T-cells that attack tumours.

Most recently, preclinical data were presented at the American Association for Cancer Research (AACR) annual meeting in April 2016 in New Orleans, US. As a proof-of-concept, Erytech has tested three antigens so far: ovalbumin (one of the best researched antigens), tyrosinase-related protein 2 (TRP2, present in melanoma, the most aggressive skin cancer) and prostate-specific antigen (PSA). The main conclusion was that immunisation with erythrocytes loaded with tumour-specific antigens induces efficient immune response against tumour. The results were consistent across different cancer cell lines (three types tested) and the approach could be used as a cancer immunotherapy. The key findings from the in vivo studies were:

All tumour antigens were efficiently encapsulated in erythrocytes with a dose-response relationship.

T-cell activation was established by measuring the destruction of target cells (which express tumour antigen) in immunised mice. Immunisation with encapsulated ovalbumin and TRP2 induced the in vivo destruction of 97% and 96% of cells containing the respective tumour antigens. Injections of free antigen destroyed less than 5% of the cells.

Tumour antigen-specific T-cell response was also analysed using an immunologic test (ELISPOT) measuring the amount of cells that secrete interferon γ (IFNγ). There were significantly more IFNγ-secreting T-cells in immunised mice (with TRP2 and PSA) than in those injected with the same free antigens (Exhibit 4). This implies more effective immunisation with Erytech’s technology that with free antigens.

A significant delay of tumour growth was found in immunised mice more than 20 days after the subcutaneous implantation of B16F10 cancer cell lines (melanoma, Exhibit 5) compared to injections with free antigen or control vehicle.

Exhibit 4: Activation of antigen-specific cytotoxic
T-cells by antigen-loaded erythrocytes

Exhibit 5: Delay of TRP2-expressing tumour growth in mice immunised with same antigen

Source: Erytech

Source: Erytech

Exhibit 4: Activation of antigen-specific cytotoxic
T-cells by antigen-loaded erythrocytes

Source: Erytech

Exhibit 5: Delay of TRP2-expressing tumour growth in mice immunised with same antigen

Source: Erytech

Although we believe the scientific rationale is sound, it is still in the preclinical stage and we do not currently include any immuno-oncology projects in our model. Nevertheless, we can see the potential of this project and a partner could emerge sooner rather than later given the widespread interest in the field and the differentiation of Erytech’s technology. Moreover, Erytech mentioned that the approach could be used to form a standalone spin-off company.

Valuation

Our Erytech’s valuation remains largely unchanged at rNPV of €321.8m (€324.9m previously) or €40.5/share. Main changes to our model include a delayed estimated launch date for Graspa/ERY-ASP in AML, a lower net cash position and somewhat increased R&D cost estimates (see financials), partly offset by an earlier launch date for Graspa/ERY-ASP in pancreatic cancer and rolling our model forward by one year. We now project the launch of Graspa/ERY-ASP for AML in 2020 (2018 previously), allowing more time for the Phase III trial, although this may happen sooner depending on the outcome of the Phase IIb results (primary data in mid-2017). We have also moved the estimated date of the launch of Graspa/ERY-ASP for pancreatic cancer from 2022 to 2021, having seen a speedy recruitment of the patients with the primary results expected in Q416.

We have made no other major changes to our underlying Graspa/ERY-ASP assumptions, maintaining our peak sales and probability for each indication. Our valuation, which is based on a risk-adjusted NPV analysis using a 12.5% discount rate, is shown in Exhibit 6.

Exhibit 6: Erytech rNPV valuation

Product

Indication

Launch

Peak sales

(€m)

NPV
(€m)

Probability (%)

rNPV
(€m)

rNPV/share (€/share)

Graspa Europe

ALL

2017

125

84.6

90%

76.7

9.7

AML

2020

165

63.0

45%

30.1

3.8

ERY-ASP US

ALL

2019

100

122.3

80%

95.8

12.1

AML

2020

120

79.1

35%

27.7

3.5

ERY-ASP

NHL

2020

220

130.1

20%

22.6

2.8

ERY-ASP

Pancreatic cancer/solid tumours

2021

300

166.0

20%

29.1

3.7

Estimated net cash at end Q116, including private placement

39.9

100%

39.9

5.0

Valuation

 

 

 

684.9

 

321.8

40.5

Source: Edison Investment Research

Financials

Erytech reported total cash and equivalents at end-Q116 of €40.6m. This was boosted by the private placement of €25.4m in gross proceeds in December 2015. With last reported debt of €0.7m at end-2015 (the majority relating to OSEO/BPI France grants), we therefore estimate that Erytech had net cash at end-Q116 of approximately €39.9m. In line with an estimated 2016 cash burn in the range of €18-20m, we have raised our costs estimates (mainly R&D) for 2016 and 2017 as a result of the expected initiation of the clinical trials.

The healthy cash balance will allow Erytech to execute on its strategy to advance ERY-ASP in the US market, in addition to moving development into front-line ALL, as well as in other indications including solid tumours and lymphomas. Underlying cash burn in Q116 was c €5.1m, up from €3.0m in Q115, but in line with expectations. Our model suggests the current cash position should be sufficient into 2018. This does not include the potential milestone payments from partner Recordati on European approval of Graspa, which would therefore extend the cash reach even further.

Exhibit 7: Key changes to our future financial forecasts and introduction of 2017 forecasts

€m

2016e

2017e

 

Old

New

Change (%)

Revenue

2.825

2.825

0%

2.903

R&D

(11.610)

(13.610)

N/M

(14.729)

SG&A

(6.869)

(8.869)

N/M

(9.135)

EBITDA

(15.362)

(19.343)

N/M

(20.632)

PBT (norm)

(14.778)

(18.767)

N/M

(20.164)

Source: Edison Investment Research


Exhibit 8: Financial summary

€'000s

2011

2012

2013

2014

2015

2016e

2017e

December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

914

5,737

1,802

2,026

2,929

2,825

2,903

Cost of Sales

0

0

0

0

0

0

0

Gross Profit

914

5,737

1,802

2,026

2,929

2,825

2,903

Research and development

(3,841)

(3,461)

(5,328)

(6,613)

(10,776)

(13,610)

(14,729)

EBITDA

 

 

(6,004)

(1,366)

(7,372)

(8,672)

(15,295)

(19,343)

(20,632)

Operating Profit (before amort. and except.)

(5,731)

(1,098)

(7,109)

(8,939)

(15,583)

(19,630)

(20,933)

Intangible Amortisation

24

24

24

(9)

0

(24)

(29)

Exceptionals

0

0

0

0

0

0

0

Other

20

(12)

20

118

0

0

0

Operating Profit

(5,688)

(1,086)

(7,065)

(8,830)

(15,583)

(19,654)

(20,962)

Net Interest

(225)

(1,079)

(1,120)

(50)

567

863

769

Profit Before Tax (norm)

 

 

(5,956)

(2,177)

(8,229)

(8,989)

(15,016)

(18,767)

(20,164)

Profit Before Tax (reported)

 

 

(5,913)

(2,164)

(8,185)

(8,880)

(15,016)

(18,791)

(20,193)

Tax

2

(8)

40

20

3

0

0

Profit After Tax (norm)

(5,934)

(2,196)

(8,169)

(8,851)

(15,013)

(18,767)

(20,164)

Profit After Tax (reported)

(5,910)

(2,172)

(8,145)

(8,860)

(15,013)

(18,791)

(20,193)

Average Number of Shares Outstanding (m)

3.2

3.2

4.7

5.9

7.0

8.0

8.1

EPS - normalised (€)

 

 

(1.88)

(0.70)

(1.74)

(1.51)

(2.16)

(2.35)

(2.49)

EPS - normalised fully diluted (€)

 

(1.88)

(0.70)

(1.74)

(1.51)

(2.16)

(2.35)

(2.49)

EPS - (reported) (€)

 

 

(1.87)

(0.69)

(1.74)

(1.51)

(2.16)

(2.35)

(2.49)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

100.0

100.0

100.0

100.0

100.0

100.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

1,276

1,005

910

1,080

1,091

971

835

Intangible Assets

49

30

14

31

61

87

107

Tangible Assets

1,015

771

813

967

918

772

616

Investments

212

204

83

82

112

112

112

Current Assets

 

 

3,665

9,139

17,039

39,526

51,929

34,578

15,783

Stocks

98

116

138

198

166

166

166

Debtors

0

0

87

105

424

155

159

Cash

2,229

7,875

15,113

36,988

45,634

28,552

9,753

Other

1,338

1,148

1,701

2,235

5,705

5,705

5,705

Current Liabilities

 

 

(1,683)

(7,477)

(3,515)

(4,258)

(5,621)

(5,957)

(6,219)

Creditors

(1,529)

(2,849)

(3,233)

(3,924)

(5,064)

(5,660)

(5,922)

Short term borrowings

(155)

(4,627)

(281)

(334)

(557)

(297)

(297)

Long Term Liabilities

 

 

(5,163)

(6,694)

(848)

(525)

(251)

(1,251)

(2,251)

Long term borrowings

(4,973)

(6,472)

(731)

(436)

(151)

(1,151)

(2,151)

Other long term liabilities

(190)

(222)

(117)

(89)

(100)

(100)

(100)

Net Assets

 

 

(1,906)

(4,027)

13,587

35,824

47,148

28,341

8,148

CASH FLOW

Operating Cash Flow

 

 

(5,073)

621

(6,473)

(7,239)

(14,605)

(18,495)

(20,374)

Net Interest

(117)

(933)

(2)

(46)

4

862

769

Tax

0

0

0

0

0

1

0

Capex

(88)

(48)

(418)

(396)

(220)

(141)

(145)

Acquisitions/disposals

0

0

0

0

0

0

0

Financing

0

0

13,938

29,173

23,544

0

0

Other

89

34

10,281

626

0

(49)

(49)

Dividends

0

0

0

0

0

0

0

Net Cash Flow

(5,189)

(326)

17,325

22,118

8,723

(17,822)

(19,800)

Opening net debt/(cash)

 

 

(2,290)

2,899

3,225

(14,101)

(36,219)

(44,926)

(27,104)

HP finance leases initiated

0

0

0

0

0

0

0

Other

0

0

0

0

(16)

0

0

Closing net debt/(cash)

 

 

2,899

3,225

(14,101)

(36,219)

(44,926)

(27,104)

(7,305)

Source: Erytech Pharma accounts, Edison Investment Research

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Frankfurt +49 (0)69 78 8076 960

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Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Gear4music Holdings — Update 29 July 2016

Gear4music Holdings

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