Erytech Pharma
Written by
Erytech Pharma |
Private placement to pursue Graspa strategy |
Private placement and clinical data |
Pharma & biotech |
17 December 2015 |
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The recent €25.4m private placement provides Erytech with a healthy cash balance, which should allow effective execution on the strategy to advance and accelerate Graspa/Eryasp in the US, to move development into front-line ALL (acute lymphoblastic leukaemia) and to continue pursuing new indications. Two-year follow up ALL data for Graspa were recently presented at ASH, reinforcing its potential as an effective, safe therapy for patients with few options in this indication. Our valuation is increased to €324.9m with the higher cash balance.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/13 |
1.8 |
(8.2) |
(1.7) |
0.0 |
N/A |
N/A |
12/14 |
2.0 |
(9.0) |
(1.5) |
0.0 |
N/A |
N/A |
12/15e |
2.6 |
(14.6) |
(2.0) |
0.0 |
N/A |
N/A |
12/16e |
2.8 |
(14.8) |
(1.9) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items.
€25.4m private placement to advance the strategy
We estimate the €25.4m private placement has boosted cash to €45-50m. Based on an estimated cash burn of c €12m in 2015 and allowing for an uptick in coming years, this should provide a runway into 2019 and allow Erytech to continue with its Graspa/Eryasp development strategy in leukaemia and beyond, in addition to advancing the pipeline. In July 2015, Erytech announced plans to conduct a US IPO; we believe it remains an option, but will be dependent on market conditions.
Two-year Graspa ALL data presented at ASH
Follow-up data from the positive Phase III ALL trial were presented at ASH. Median event-free survival (EFS) was 11.8 months in the native L-asparaginase arm, but had not been reached in the Graspa arm after two years. This highlights Graspa’s potential to improve outcomes for patients, without L-asp tolerability issues.
Graspa/Eryasp in leukaemia and beyond
With Graspa already filed in Europe in ALL and a decision expected by YE16, the focus is on the US and new indications. A Phase Ib study in ALL in the US is ongoing and set to accelerate; data are expected in 2016. Erytech is also planning to move development into frontline ALL, in addition to patients allergic to both forms of asparaginase (‘double-allergic’), which could provide an expedited path to market in the US. A Phase IIb trial in AML (acute myeloid leukaemia) is ongoing in Europe, funded by partner Recordati; initial overall survival data are expected in 2017. A Phase II trial in pancreatic cancer is underway and first data are expected in 2016. A Phase II trial in NHL is planned to start in 2016.
Valuation: rNPV of €324.9m or €41.4/share
Our valuation has increased to €324.9m (from €299m) largely owing to incorporation of the recent €25.4m private placement. We have made no major changes to our underlying Graspa/Eryasp forecasts, which continue to assume that Erytech will retain development and commercialisation rights in ALL in the US.
Valuation
Our Erytech valuation has been updated to reflect the €25.4m private placement, with our NPV and rNPV both increased with the higher cash balance, in addition to rolling forwards in time. Our increased rNPV is €324.9m (from €299m) or €41.4/share with the higher share count. We have made no major changes to our underlying Graspa/Eryasp assumptions (maintaining our peak sales, launch year and probability of success for each indication), which continue to assume that Erytech will build out a small commercial infrastructure in the US, potentially starting in the double-allergic ALL patients. Our valuation, which is based on a risk-adjusted NPV analysis using a 12.5% discount rate is shown in Exhibit 1.
Exhibit 1: Erytech rNPV valuation
Product |
Indication |
Launch |
Peak sales (€m) |
NPV |
Probability (%) |
rNPV |
rNPV/share (€/share) |
GRASPA Europe |
ALL |
2017 |
125 |
83.5 |
90% |
75.4 |
9.6 |
AML |
2018 |
165 |
90.6 |
45% |
41.8 |
5.3 |
|
Eryasp US |
ALL |
2019 |
100 |
118.8 |
80% |
93.6 |
11.9 |
AML |
2020 |
120 |
71.6 |
35% |
28.3 |
3.6 |
|
Eryasp |
NHL |
2020 |
220 |
118.9 |
20% |
19.7 |
2.5 |
Eryasp |
Pancreatic cancer/solid tumours |
2022 |
300 |
98.1 |
20% |
14.5 |
1.8 |
Estimated net cash at end September and including private placement |
51.6 |
100% |
51.6 |
6.6 |
|||
Valuation |
|
|
|
633.0 |
324.9 |
41.4 |
|
Source: Edison Investment Research
Financials
Erytech recently completed a private placement raising €25.4m gross proceeds (we estimate €24.1m net) from issuing 940k shares at €27/share. We have incorporated this in our financial forecasts, with slightly higher interest income owing to the larger cash balance. A summary of the changes to our estimates is shown in Exhibit 2 and our updated forecasts are shown in Exhibit 3.
Erytech reported total cash and equivalents at end-September 2015 of €28.2m. Together with last reported debt of €0.7m at end-June 2015 (the majority relating to OSEO/BPI France grants, some of which are repayable over the next two years), we therefore estimate Erytech had net cash at end September of approximately €27.5m. This was recently boosted with the private placement, taking net cash to around €51.6m (excluding any potential cash burn). Assuming around €1m/month cash burn suggests current net cash of around €45-50m.
This is a healthy cash balance that will allow Erytech to execute on its strategy to advance Eryasp 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 H115 was c €5.9m and Erytech estimates that cash burn in 2015 will be at the higher end of €10-12m, (we forecast cash burn of €12.1m in 2015). We assume that cash burn will increase in future years to around €13-15m, suggesting the current cash pile should be sufficient into 2019. This does not include the potential milestone payment of €7-8m, due from partner Recordati upon European Graspa approval, anticipated around YE16, which would therefore extend the cash reach even further.
Exhibit 2: Summary of key changes to our future financial forecasts
€m |
2015e |
2015e |
Change |
2016e |
2016e |
Change |
|
Old |
New |
Old |
New |
||
Revenue |
2.618 |
2.618 |
0% |
2.825 |
2.825 |
0% |
R&D |
(11.300) |
(11.300) |
0% |
(11.610) |
(11.610) |
0% |
SG&A |
(6.542) |
(6.542) |
0% |
(6.869) |
(6.869) |
0% |
EBITDA |
(14.947) |
(14.947) |
0% |
(15.362) |
(15.362) |
0% |
Net profit (reported) |
(14.768) |
(14.586) |
+1% |
(15.281) |
(14.791) |
+3% |
Source: Edison Investment Research
Exhibit 3: Financial summary
€000s |
2011 |
2012 |
2013 |
2014 |
2015e |
2016e |
||
Year-end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||||
Revenue |
|
|
914 |
5,737 |
1,802 |
2,026 |
2,618 |
2,825 |
Cost of Sales |
0 |
0 |
0 |
0 |
0 |
0 |
||
Gross Profit |
914 |
5,737 |
1,802 |
2,026 |
2,618 |
2,825 |
||
Research and development |
(3,841) |
(3,461) |
(5,328) |
(6,613) |
(11,300) |
(11,610) |
||
EBITDA |
|
|
(6,004) |
(1,366) |
(7,372) |
(8,672) |
(14,947) |
(15,362) |
Operating Profit (before amort. and except.) |
(5,731) |
(1,098) |
(7,109) |
(8,939) |
(15,213) |
(15,641) |
||
Intangible Amortisation |
24 |
24 |
24 |
(9) |
(11) |
(13) |
||
Exceptionals |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
20 |
(12) |
20 |
118 |
0 |
0 |
||
Operating Profit |
(5,688) |
(1,086) |
(7,065) |
(8,830) |
(15,224) |
(15,654) |
||
Net Interest |
(225) |
(1,079) |
(1,120) |
(50) |
638 |
863 |
||
Profit Before Tax (norm) |
|
|
(5,956) |
(2,177) |
(8,229) |
(8,989) |
(14,575) |
(14,778) |
Profit Before Tax (reported) |
|
|
(5,913) |
(2,164) |
(8,185) |
(8,880) |
(14,586) |
(14,791) |
Tax |
2 |
(8) |
40 |
20 |
0 |
0 |
||
Profit After Tax (norm) |
(5,934) |
(2,196) |
(8,169) |
(8,851) |
(14,575) |
(14,778) |
||
Profit After Tax (reported) |
(5,910) |
(2,172) |
(8,145) |
(8,860) |
(14,586) |
(14,791) |
||
Average Number of Shares Outstanding (m) |
3.2 |
3.2 |
4.7 |
5.9 |
7.4 |
7.9 |
||
EPS - normalised (EUR) |
|
|
(1.88) |
(0.70) |
(1.74) |
(1.51) |
(1.98) |
(1.88) |
EPS - normalised fully diluted (EUR) |
|
(1.88) |
(0.70) |
(1.74) |
(1.51) |
(1.98) |
(1.88) |
|
EPS - (reported) (EUR) |
|
|
(1.87) |
(0.69) |
(1.74) |
(1.51) |
(1.98) |
(1.88) |
Dividend per share (EUR) |
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 |
||
EBITDA Margin (%) |
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 |
||
BALANCE SHEET |
||||||||
Fixed Assets |
|
|
1,276 |
1,005 |
910 |
1,080 |
960 |
835 |
Intangible Assets |
49 |
30 |
14 |
31 |
46 |
59 |
||
Tangible Assets |
1,015 |
771 |
813 |
967 |
832 |
694 |
||
Investments |
212 |
204 |
83 |
82 |
82 |
82 |
||
Current Assets |
|
|
3,665 |
9,139 |
17,039 |
39,526 |
52,439 |
39,869 |
Stocks |
98 |
116 |
138 |
198 |
198 |
198 |
||
Debtors |
0 |
0 |
87 |
105 |
143 |
155 |
||
Cash |
2,229 |
7,875 |
15,113 |
36,988 |
49,863 |
37,281 |
||
Other |
1,338 |
1,148 |
1,701 |
2,235 |
2,235 |
2,235 |
||
Current Liabilities |
|
|
(1,683) |
(7,477) |
(3,515) |
(4,258) |
(5,549) |
(5,409) |
Creditors |
(1,529) |
(2,849) |
(3,233) |
(3,924) |
(5,213) |
(5,333) |
||
Short term borrowings |
(155) |
(4,627) |
(281) |
(334) |
(336) |
(76) |
||
Long Term Liabilities |
|
|
(5,163) |
(6,694) |
(848) |
(525) |
(1,265) |
(2,265) |
Long term borrowings |
(4,973) |
(6,472) |
(731) |
(436) |
(1,176) |
(2,176) |
||
Other long term liabilities |
(190) |
(222) |
(117) |
(89) |
(89) |
(89) |
||
Net Assets |
|
|
(1,906) |
(4,027) |
13,587 |
35,824 |
46,585 |
33,030 |
CASH FLOW |
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Operating Cash Flow |
|
|
(5,073) |
621 |
(6,473) |
(7,239) |
(12,466) |
(14,018) |
Net Interest |
(117) |
(933) |
(2) |
(46) |
638 |
863 |
||
Tax |
0 |
0 |
0 |
0 |
5 |
0 |
||
Capex |
(88) |
(48) |
(418) |
(396) |
(131) |
(141) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
0 |
0 |
||
Financing |
0 |
0 |
13,938 |
29,173 |
24,111 |
0 |
||
Other |
89 |
34 |
10,281 |
626 |
(26) |
(26) |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
0 |
||
Net Cash Flow |
(5,189) |
(326) |
17,325 |
22,118 |
12,132 |
(13,322) |
||
Opening net debt/(cash) |
|
|
(2,290) |
2,899 |
3,225 |
(14,101) |
(36,219) |
(48,351) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
||
Closing net debt/(cash) |
|
|
2,899 |
3,225 |
(14,101) |
(36,219) |
(48,351) |
(35,029) |
Source: Erytech accounts, Edison Investment Research. Note: Our financial forecasts exclude Graspa royalty income until formal approval.
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