In a well-received announcement, ASIT has launched the confirmatory Phase III study on gp-ASIT+ for grass pollen allergy with study centres in six European countries. The results of the study are expected in December 2019. ASIT has learned from the previous Phase III study by making a number of improvements to the protocol to enhance the chances of success. In addition, ASIT has made announcements on its other products illustrating its pipeline in allergy extends beyond gp-ASIT+.
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ASIT biotech |
The 82-centre gp-ASIT+ Phase III study launches |
Phase III starts |
Pharma & biotech |
20 November 2018 |
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In a well-received announcement, ASIT has launched the confirmatory Phase III study on gp-ASIT+ for grass pollen allergy with study centres in six European countries. The results of the study are expected in December 2019. ASIT has learned from the previous Phase III study by making a number of improvements to the protocol to enhance the chances of success. In addition, ASIT has made announcements on its other products illustrating its pipeline in allergy extends beyond gp-ASIT+.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/17 |
0.0 |
(12.0) |
(0.9) |
0.0 |
N/A |
N/A |
12/18e |
0.0 |
(13.3) |
(0.9) |
0.0 |
N/A |
N/A |
12/19e |
0.0 |
(16.1) |
(0.9) |
0.0 |
N/A |
N/A |
12/20e |
0.0 |
(6.2) |
(0.3) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are both as reported.
(Protocol) change is good
The primary endpoint of the Phase III study of gp-ASIT+ for grass pollen allergy remains the same as in the first Phase III study that reported in 2017: a 20% reduction in the combined clinical symptom and medication score in the treatment arm compared to the placebo patients. However, a number of potentially confounding variables have been addressed in the planned conduct of this second confirmatory study. The choice of ICON as the single clinical research organisation for the study brings ICON’s deep experience in running allergy clinical trials. Of the eight other improvements in the Phase III protocol, the restriction in the maximum number of patients that can be recruited at any one of the centres and the increase in the number of patients to 624 (from 554 in the first Phase III study) are the most important. An earlier launch date in the pollen season, the recruitment of more severe patients than in the first Phase III study and the selection of centres with regular historical pollen levels are also important variables to re-define.
pnt-ASIT+ accelerates
ASIT recently announced the finalisation of the manufacturing process for its short-course peptide vaccination (pnt-ASIT+) to treat peanut allergies that will be used in the Phase I/II studies expected to start in H219. Like ASIT’s other products, the peptides comprising pnt-ASIT+ were selected and tested by interdisciplinary teams at Imperial Collage London to have significantly less anaphylactic potential than the native antigen but retain the potential to down-regulate the immune response. There are revenue-smoothing advantages to ASIT’s portfolio because grass pollen allergies result in a large number of seasonal symptomatic patients, with little mortality, whereas peanut allergies result in a smaller number of year-round, but potentially fatal food allergies.
Valuation: Unchanged
We have not changed our valuation, which remains €118m or €6.7 per share. We will be keeping a close eye on the catalyst of the severity of the 2019 allergy season and note that commercialisation will require further funding in 2020.
Exhibit 1: Financial summary
|
|
|
€000s |
2015 |
2016 |
2017 |
2018e |
2019e |
2020e |
Year end 31 December |
|
|
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
|
INCOME STATEMENT |
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
4 |
0 |
0 |
0 |
0 |
0 |
Cost of Sales |
|
|
|
(3) |
0 |
0 |
0 |
0 |
0 |
Gross Profit |
|
|
|
1 |
0 |
0 |
0 |
0 |
0 |
General and Administrative Expenses |
|
(947) |
(1,822) |
(1,676) |
(2,547) |
(2,522) |
(2,497) |
||
Research and Development Expenses |
|
(6,691) |
(12,123) |
(10,903) |
(11,500) |
(14,480) |
(4,520) |
||
Other Operating Income |
|
|
(3) |
1,667 |
604 |
789 |
829 |
870 |
|
Reported operating profit |
|
|
(7,640) |
(12,278) |
(11,975) |
(13,258) |
(16,173) |
(6,146) |
|
Net Interest |
|
|
|
(75) |
(60) |
(9) |
(40) |
113 |
(49) |
Profit before tax (as reported) |
|
|
(7,715) |
(12,338) |
(11,984) |
(13,298) |
(16,060) |
(6,196) |
|
Reported tax |
|
|
|
0 |
(1) |
(2) |
(1) |
3 |
1,859 |
Profit after tax (reported) |
|
|
(7,715) |
(12,339) |
(11,986) |
(13,298) |
(16,057) |
(4,337) |
|
Minority interests |
|
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Net income (reported) |
|
|
(7,715) |
(12,339) |
(11,986) |
(13,298) |
(16,057) |
(4,337) |
|
|
|
|
|
|
|
|
|
|
|
Basic average number of shares outstanding (m) |
|
8,504 |
11,219 |
12,806 |
15,694 |
17,507 |
17,507 |
||
EPS - basic, as reported (€) |
|
(0.91) |
(1.10) |
(0.94) |
(0.85) |
(0.92) |
(0.25) |
||
|
|
|
|
|
|
|
|
|
|
BALANCE SHEET |
|
|
|
|
|
|
|
|
|
Non-Current Assets |
|
|
506 |
1,770 |
1,837 |
2,008 |
2,136 |
2,044 |
|
Property Plant and equipment, net |
|
494 |
736 |
691 |
693 |
821 |
729 |
||
Other intangible assets |
|
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Other Non Current Assets |
|
|
12 |
1,034 |
1,146 |
1,315 |
1,315 |
1,315 |
|
Current Assets |
|
|
4,968 |
13,785 |
2,448 |
9,851 |
(126) |
9,987 |
|
Cash and cash equivalents |
|
|
4,621 |
13,387 |
2,126 |
9,598 |
(379) |
9,734 |
|
Accounts receivable |
|
|
2 |
3 |
0 |
0 |
0 |
0 |
|
Inventories |
|
|
|
11 |
0 |
0 |
0 |
0 |
0 |
Other current assets |
|
|
334 |
395 |
322 |
253 |
253 |
253 |
|
Current Liabilities |
|
|
6,332 |
2,004 |
2,654 |
5,286 |
4,294 |
2,853 |
|
Accounts payable |
|
|
1,611 |
1,707 |
1,264 |
3,444 |
2,452 |
1,011 |
|
Short term debt and borrowings |
|
4,232 |
12 |
34 |
38 |
38 |
38 |
||
Other current liabilities |
|
|
489 |
285 |
1,356 |
1,804 |
1,804 |
1,804 |
|
Non-Current Liabilities |
|
|
0 |
419 |
432 |
446 |
446 |
7,446 |
|
Loans and borrowings |
|
|
0 |
419 |
432 |
446 |
446 |
7,446 |
|
Other non-current liabilities |
|
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Equity |
|
|
|
(858) |
13,132 |
1,199 |
6,126 |
(2,731) |
(5,268) |
Common stock / Capital |
|
|
11,625 |
17,506 |
9,989 |
13,125 |
13,125 |
13,125 |
|
Additional paid-in capital / Share premium |
|
0 |
21,957 |
21,957 |
26,958 |
18,101 |
15,564 |
||
Other reserves and surplus |
|
|
(12,483) |
(24,229) |
(28,645) |
(33,957) |
(33,957) |
(33,957) |
|
Other Equity |
|
|
|
0 |
(2,102) |
(2,102) |
0 |
0 |
0 |
CASH FLOW |
|
|
|
|
|
|
|
|
|
Cash Flow from Operations |
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(7,715) |
(12,339) |
(11,986) |
(13,298) |
(16,057) |
(4,337) |
|
Depreciation and Amortization |
|
|
80 |
141 |
205 |
176 |
196 |
214 |
|
Interest income/expense |
|
|
75 |
60 |
9 |
40 |
(113) |
49 |
|
Stock-based compensation |
|
|
18 |
0 |
54 |
0 |
0 |
0 |
|
Non Cash Adjustments |
|
|
0 |
11 |
(492) |
0 |
0 |
0 |
|
(Increase) decrease in inventories |
|
3 |
0 |
0 |
0 |
0 |
0 |
||
(Increase) decrease in trade receivables |
|
(819) |
(62) |
74 |
0 |
0 |
0 |
||
(Increase) decrease in other current assets |
|
0 |
(1,016) |
(112) |
69 |
0 |
0 |
||
Increase (decrease) in trade payables |
|
751 |
(492) |
(586) |
2,180 |
(992) |
(1,441) |
||
Net cash used in Operating activities |
|
(7,606) |
(13,697) |
(12,834) |
(10,833) |
(16,966) |
(5,515) |
||
Cash Flow from Investing |
|
|
|
|
|
|
|
|
|
Purchases of fixed assets |
|
|
(372) |
(383) |
(161) |
(265) |
(323) |
(123) |
|
Other Investing Activities |
|
|
1 |
(6) |
0 |
0 |
0 |
0 |
|
Net cash used in Investing activities |
|
(371) |
(389) |
(161) |
(265) |
(323) |
(123) |
||
Cash Flow from Financing |
|
|
|
|
|
|
|
|
|
Change in Debt |
|
|
4,130 |
0 |
0 |
0 |
0 |
7,000 |
|
Change in Capital Stock |
|
|
0 |
22,199 |
0 |
16,900 |
7,200 |
1,800 |
|
Interest paid |
|
|
|
(6) |
(204) |
(10) |
(42) |
(24) |
(24) |
Other Financing Activities |
|
|
33 |
857 |
1,743 |
2 |
137 |
(25) |
|
Net cash used in Financing activities |
|
4,157 |
22,852 |
1,733 |
16,860 |
7,313 |
8,751 |
||
Net Changes in Cash and Cash Equivalent |
|
(3,820) |
8,766 |
(11,262) |
5,761 |
(9,976) |
3,113 |
||
Net cash (debt) at the beginning of the period |
|
8,441 |
4,621 |
12,968 |
1,694 |
9,152 |
(825) |
||
Net cash (debt) at the end of the period |
|
4,621 |
12,968 |
1,694 |
9,152 |
(825) |
2,288 |
||
Source: Company accounts, Edison Investment Research
|
|
Research: Real Estate
Picton had a good half year, maintaining a high level of occupancy and income, generating year-on-year growth in EPRA earnings and dividends, and reducing gearing further. The portfolio is strongly biased towards the better-performing industrial and regional office property markets and offers significant reversionary potential. Entry to the UK REIT regime will avoid negative effects from recent UK tax law changes, while the change in its listing status to that of a commercial company, from an investment company, improves administrative flexibility.