Paion |
A setback in Europe, but US on track |
EU Phase III stopped |
Pharma & biotech |
10 February 2016 |
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Paion is a research client of Edison Investment Research Limited |
Paion has discontinued its European Phase III trial of remimazolam for general anaesthesia in patients undergoing cardiac surgery due to slow recruitment. The US Phase III in colonoscopy is still on track to complete recruitment in the current quarter, but completion of the bronchoscopy Phase III may be pushed into 2017. Paion remains on track for a potential US filing in 2017, while a pre-NDA meeting with Japanese regulators in Q116 could clear the way for a filing in Japan, ideally with a partner. We delay our forecast launch date for general anaesthesia in Europe by two years to 2020 and lower our valuation to €182m from €230m.
Year end |
Revenue (€m) |
PBT* (€m) |
EPS* (c) |
DPS (c) |
P/E (x) |
Yield (%) |
12/13 |
4.2 |
(2.6) |
(7.2) |
0.0 |
N/A |
N/A |
12/14 |
3.5 |
(11.6) |
(22.9) |
0.0 |
N/A |
N/A |
12/15e |
0.0 |
(33.8) |
(55.9) |
0.0 |
N/A |
N/A |
12/16e |
1.0 |
(30.8) |
(52.2) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items and share-based payments.
We see potential two-year delay in Europe
Paion announced that the Phase III trial of the ultrashort-acting anaesthetic remimazolam in patients undergoing cardiac surgery faced recruitment challenges due to the complex study design. The discontinuation of the trial, initiated in August 2015, will allow additional resources to be allocated to the development of remimazolam in the US. Paion will work to design an alternative trial in general surgery patients, allowing it to develop a clinical plan in Europe once funding is available. We assume that the revised plan will enable approval for general anaesthesia in Europe in 2020 vs 2018 previously.
US Phase III trials on track, results in 2016
The US colonoscopy trial is expected to complete recruitment this quarter, with data in mid-2016, but moderate recruitment may see completion of the bronchoscopy Phase III pushed into 2017. Management cautioned that filing for approval in procedural sedation in the US by the end of 2017 is contingent on the success of ongoing measures to improve recruitment in the bronchoscopy trial, including opening new sites and increased support and training at existing centres. A pre-NDA meeting with the Japanese regulator (PMDA), scheduled for Q116, could clear the way for a filing for general anaesthesia in Japan, preferably in conjunction with a partner.
Valuation: Trimmed to €182m; trials fully funded
We have pushed back our launch date for remimazolam in Europe by two years to 2020, which reduces our sum-of-the-parts DCF valuation to €182m or €3.59/share (vs €230m). Cash at 30 September of €40.5m is sufficient to complete the ongoing Phase III studies. Savings from the discontinuation of the Phase III trial in Europe will be used to support and enhance the US clinical programme. Paion is evaluating the prospect of self-commercialisation of remimazolam in the US, which could lead to 45% profit margins in some regions, subject to further fund-raising (our current base case assumes a 23% blended royalty rate).
Exhibit 1: Financial summary
€000s |
2013 |
2014 |
2015e |
2016e |
||
Year end 31 December |
||||||
PROFIT & LOSS |
||||||
Revenue |
|
|
4,228 |
3,456 |
0 |
1,000 |
Cost of sales |
0 |
(4) |
0 |
0 |
||
Gross profit |
4,228 |
3,452 |
0 |
1,000 |
||
R&D expenditure |
(4,583) |
(11,799) |
(28,000) |
(25,000) |
||
General, administrative & selling |
(3,314) |
(3,702) |
(6,000) |
(7,000) |
||
Other |
860 |
411 |
50 |
51 |
||
Operating profit |
(2,810) |
(11,639) |
(33,950) |
(30,949) |
||
Depreciation and amortisation |
(390) |
(93) |
(100) |
(100) |
||
Share-based payments |
0 |
0 |
0 |
0 |
||
Exceptionals |
0 |
0 |
0 |
0 |
||
EBITDA |
|
|
(2,420) |
(11,546) |
(33,850) |
(30,849) |
Operating profit (before GW and except) |
|
(2,420) |
(11,546) |
(33,850) |
(30,849) |
|
Net interest |
(170) |
(66) |
50 |
50 |
||
Profit before tax (norm) |
|
|
(2,590) |
(11,612) |
(33,800) |
(30,799) |
Profit before tax (reported) |
|
|
(2,980) |
(11,704) |
(33,900) |
(30,899) |
Tax |
768 |
2,468 |
5,500 |
4,375 |
||
Profit after tax (norm) |
(1,822) |
(9,143) |
(28,300) |
(26,424) |
||
Profit after tax (reported) |
(2,212) |
(9,236) |
(28,400) |
(26,524) |
||
Average number of shares outstanding (m) |
25.4 |
39.9 |
50.7 |
50.7 |
||
EPS - normalised (c) |
|
|
(7.2) |
(22.9) |
(55.9) |
(52.2) |
EPS - reported (c) |
|
|
(8.7) |
(23.2) |
(56.1) |
(52.4) |
Dividend per share (c) |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Gross margin (%) |
N/A |
N/A |
N/A |
N/A |
||
EBITDA margin (%) |
N/A |
N/A |
N/A |
N/A |
||
Operating margin (before GW and except.) (%) |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
||||||
Fixed assets |
|
|
3,583 |
3,516 |
3,416 |
3,316 |
Intangible assets |
3,494 |
3,440 |
3,365 |
3,290 |
||
Tangible assets |
89 |
76 |
51 |
26 |
||
Refund from assumption of dev costs |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
||
Current assets |
|
|
14,433 |
63,032 |
38,140 |
11,717 |
Stocks |
0 |
0 |
0 |
0 |
||
Debtors |
0 |
467 |
25 |
25 |
||
Cash |
13,292 |
58,912 |
33,115 |
6,692 |
||
Other |
1,141 |
3,653 |
5,000 |
5,000 |
||
Current liabilities |
|
|
(4,659) |
(3,924) |
(6,157) |
(6,157) |
Trade payables |
(1,914) |
(3,338) |
(5,400) |
(5,400) |
||
Short-term borrowings |
0 |
0 |
0 |
0 |
||
Provisions |
(2,508) |
(306) |
(500) |
(500) |
||
Finance lease liabilities |
0 |
0 |
0 |
0 |
||
Other current liabilities |
(225) |
(254) |
(235) |
(235) |
||
Current deferred income |
(11) |
(26) |
(22) |
(22) |
||
Long-term liabilities |
|
|
(28) |
(17) |
(8) |
(8) |
Long-term borrowings |
0 |
0 |
0 |
0 |
||
Provisions |
0 |
0 |
0 |
0 |
||
Long-term deferred income |
(28) |
(17) |
(8) |
(8) |
||
Deferred taxes |
0 |
0 |
0 |
0 |
||
Other long-term liabilities |
0 |
0 |
0 |
0 |
||
Net assets |
|
|
13,329 |
62,607 |
35,391 |
8,868 |
CASH FLOW |
||||||
Operating cash flow |
|
|
(1,746) |
(12,044) |
(31,346) |
(30,849) |
Net interest |
(170) |
(66) |
50 |
50 |
||
Tax |
75 |
0 |
5,500 |
4,375 |
||
Capex |
0 |
0 |
0 |
0 |
||
Purchase of intangibles |
(5) |
(26) |
0 |
0 |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
||
Financing |
(7,164) |
57,618 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
||
Net cash flow |
(9,010) |
45,482 |
(25,796) |
(26,424) |
||
Opening net debt/(cash) |
|
|
(22,336) |
(13,292) |
(58,912) |
(33,116) |
Effect of exchange rate changes |
(130) |
(72) |
0 |
0 |
||
Other |
96 |
210 |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(13,292) |
(58,912) |
(33,116) |
(6,691) |
Source: Edison Investment Research, company accounts
|