Paion |
Colonoscopy Phase III success prompts US deal |
Phase III success and |
Pharma & biotech |
5 July 2016 |
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Paion is a research client of Edison Investment Research Limited |
Paion reported positive top-line results from its Phase III colonoscopy trial and promptly out-licensed US rights to Cosmo Pharmaceuticals. The deal brings c €20m of cash (including a €9.6m share purchase), €42.5m potential milestones and a 20-25% royalty. The next goal is end of recruitment in the bronchoscopy Phase III expected in late 2016/early 2017, with results two to three months later. We lift our valuation to €203m (vs €193m); the share issue sees our per-share valuation fall to €3.65/share (vs €3.81/share).
Year end |
Revenue (€m) |
PBT* (€m) |
EPS* (c) |
DPS (c) |
P/E (x) |
Yield (%) |
12/14 |
3.5 |
(11.6) |
(22.9) |
0.0 |
N/A |
N/A |
12/15 |
0.1 |
(34.0) |
(55.7) |
0.0 |
N/A |
N/A |
12/16e |
10.1 |
(20.6) |
(30.7) |
0.0 |
N/A |
N/A |
12/17e |
2.2 |
(8.4) |
(13.3) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Positive results from US colonoscopy Phase III
Paion reported positive top-line results from the first of two US pivotal studies of short-acting anaesthetic remimazolam in procedural sedation; 91% of patients in the remimazolam arm achieved the primary outcome (completion of the colonoscopy procedure without rescue medication) and 5% on placebo. The success rate was comparable to the three remimazolam dose groups in Phase II (92.5-97.5%). The safety profile was consistent with that seen in earlier studies.
Colonoscopy market a core focus for Cosmo
The licence deal brings €10m upfront cash, an equity injection of €10m (€0.4m deferred) plus regulatory milestones of €42.5m and a tiered royalty of 20-25% (which can be as low as 15% in certain product pricing conditions). Cosmo will fund regulatory filing and commercialisation in the US, while Paion will fund the bronchoscopy Phase III. Cosmo is active in the colonoscopy market, with an approved product (Eleview) and another (Methylene Blue MMX) in Phase III; remimazolam’s rapid onset and short wake-up time in procedural sedation will be a complementary addition to its product portfolio and improve its offering to gastroenterologists.
Deal reduces funding and execution risk
The €19.6m cash from Cosmo plus €25.6m cash at 31 March is sufficient to fund operations to potential US approval at end-2018, while the decision not to self-commercialise remimazolam in the US further reduces risk. Paion is in discussions with prospective partners for a potential Japan filing (we assume filing in H217).
Valuation: Cash plus lower risk lifts value to €203m
Cosmo upfronts and milestones totalling €52.5m are below our forecast €85m total. Headline royalty rates of 20-25% are in line, but the possibility of the rate falling as low as 15% sees us lower our royalty assumption to 20% (vs 23%). We adjust our deal terms for Europe and Japan down to match the US deal. Success in the first Phase III trial sees us increase likelihood of US approval to 75% (vs 60%). These changes and the equity issue lift our valuation to €203m (vs €193m); per share valuation falls to €3.65/share (vs €3.81/share) due to the shares issued to Cosmo.
Exhibit 1: Financial summary
€'000s |
2014 |
2015 |
2016e |
2017e |
||
Year end 31 December |
||||||
PROFIT & LOSS |
||||||
Revenue |
|
|
3,456 |
61 |
10,100 |
2,225 |
Cost of sales |
(4) |
0 |
0 |
0 |
||
Gross profit |
3,452 |
61 |
10,100 |
2,225 |
||
R&D expenditure |
(11,799) |
(29,385) |
(26,000) |
(6,000) |
||
General, administrative & selling |
(3,702) |
(5,729) |
(4,900) |
(4,800) |
||
Other |
411 |
965 |
51 |
51 |
||
Operating profit |
(11,639) |
(34,088) |
(20,749) |
(8,524) |
||
Depreciation and amortisation |
(93) |
0 |
(100) |
(100) |
||
Share-based payments |
0 |
0 |
0 |
0 |
||
Exceptionals |
0 |
0 |
0 |
0 |
||
EBITDA |
|
|
(11,546) |
(34,088) |
(20,649) |
(8,424) |
Operating profit (before GW and except) |
|
(11,546) |
(34,088) |
(20,649) |
(8,424) |
|
Net interest |
(66) |
42 |
50 |
20 |
||
Profit before tax (norm) |
|
|
(11,612) |
(34,046) |
(20,599) |
(8,404) |
Profit before tax (reported) |
|
|
(11,704) |
(34,046) |
(20,699) |
(8,504) |
Tax |
2,468 |
5,834 |
4,290 |
990 |
||
Profit after tax (norm) |
(9,143) |
(28,212) |
(16,309) |
(7,414) |
||
Profit after tax (reported) |
(9,236) |
(28,212) |
(16,409) |
(7,514) |
||
Average number of shares outstanding (m) |
39.9 |
50.7 |
53.2 |
55.7 |
||
EPS - normalised (c) |
|
|
(22.9) |
(55.7) |
(30.7) |
(13.3) |
EPS - reported (c) |
|
|
(23.2) |
(55.7) |
(30.8) |
(13.5) |
Dividend per share (c) |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Gross margin (%) |
NA |
NA |
NA |
NA |
||
EBITDA margin (%) |
NA |
NA |
NA |
NA |
||
Operating margin (before GW and except.) (%) |
NA |
NA |
NA |
NA |
||
BALANCE SHEET |
||||||
Fixed assets |
|
|
3,516 |
3,417 |
3,317 |
3,217 |
Intangible assets |
3,440 |
3,362 |
3,287 |
3,212 |
||
Tangible assets |
76 |
56 |
31 |
6 |
||
Refund from assumption of dev costs |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
||
Current assets |
|
|
63,032 |
40,051 |
33,342 |
30,928 |
Stocks |
0 |
0 |
0 |
0 |
||
Debtors |
467 |
0 |
0 |
25 |
||
Cash |
58,912 |
32,680 |
25,971 |
23,532 |
||
Other |
3,653 |
7,371 |
7,371 |
7,371 |
||
Current liabilities |
|
|
(3,924) |
(7,901) |
(7,901) |
(7,901) |
Trade payables |
(3,338) |
(7,332) |
(7,332) |
(7,332) |
||
Short-term borrowings |
0 |
0 |
0 |
0 |
||
Provisions |
(306) |
(224) |
(224) |
(224) |
||
Finance lease liabilities |
0 |
0 |
0 |
0 |
||
Other current liabilities |
(254) |
(305) |
(305) |
(305) |
||
Current deferred income |
(26) |
(39) |
(39) |
(39) |
||
Long-term liabilities |
|
|
(17) |
(6) |
(6) |
(5,006) |
Long-term borrowings |
0 |
0 |
0 |
(5,000) |
||
Provisions |
0 |
0 |
0 |
0 |
||
Long-term deferred income |
(17) |
(6) |
(6) |
(6) |
||
Deferred taxes |
0 |
0 |
0 |
0 |
||
Other long-term liabilities |
0 |
0 |
0 |
0 |
||
Net assets |
|
|
62,607 |
35,562 |
28,753 |
21,239 |
CASH FLOW |
||||||
Operating cash flow |
|
|
(12,044) |
(28,212) |
(20,649) |
(8,449) |
Net interest |
(66) |
43 |
50 |
20 |
||
Tax |
0 |
2,575 |
4,290 |
990 |
||
Capex |
0 |
0 |
0 |
0 |
||
Purchase of intangibles |
(26) |
(33) |
0 |
0 |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
||
Equity Financing |
57,618 |
22 |
9,600 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
||
Net cash flow |
45,482 |
(25,605) |
(6,709) |
(7,439) |
||
Opening net debt/(cash) |
|
|
(13,292) |
(58,912) |
(32,680) |
(25,971) |
Effect of exchange rate changes |
(72) |
(66) |
0 |
0 |
||
Other |
210 |
(560) |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(58,912) |
(32,680) |
(25,971) |
(18,532) |
Source: Edison Investment Research, Paion accounts
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