Factor Therapeutics updated the market that at the end of Q117, 12 venous leg ulcer (VLU) patients had been randomised to VF-001 or placebo in its Phase IIb trial, with a further 11 patients undergoing the two-week screening period prior to randomisation. We model the recruitment rate steadily increasing to 50 subjects entering screening per month (33 randomised), with the 168-patient trial being fully recruited by September. This would allow the last patient to complete their 12-week follow-up visit in December, with top-line data for the per cent wound closure primary end point reported in Q118. This timing would represent slight slippage on the company’s target of top-line data read-out in Q417, but would leave our key valuation assumptions intact. Our valuation is unchanged at A$108m or A$0.15 per share.
Written by
Factor Therapeutics |
Recruitment in VLU Phase IIb expected to build |
Clinical trial update |
Pharma & biotech |
17 May 2017 |
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Factor Therapeutics updated the market that at the end of Q117, 12 venous leg ulcer (VLU) patients had been randomised to VF-001 or placebo in its Phase IIb trial, with a further 11 patients undergoing the two-week screening period prior to randomisation. We model the recruitment rate steadily increasing to 50 subjects entering screening per month (33 randomised), with the 168-patient trial being fully recruited by September. This would allow the last patient to complete their 12-week follow-up visit in December, with top-line data for the per cent wound closure primary end point reported in Q118. This timing would represent slight slippage on the company’s target of top-line data read-out in Q417, but would leave our key valuation assumptions intact. Our valuation is unchanged at A$108m or A$0.15 per share.
Year |
Revenue |
PBT* |
EPS* |
DPS* |
P/E |
Yield |
06/15 |
0.4 |
(7.1) |
(4.0) |
0.0 |
N/A |
N/A |
06/16 |
0.4 |
(4.1) |
(3.0) |
0.0 |
N/A |
N/A |
06/17e |
2.6 |
(5.4) |
(0.8) |
0.0 |
N/A |
N/A |
06/18e |
1.8 |
(4.6) |
(0.6) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Most planned sites actively recruiting
Recruitment in the US-based VF-001 Phase IIb trial began in December 2016. By the end of Q117, 21 of the planned 26 sites were actively recruiting, with most of the sites having been contracted and initiated in February and March. The final five sites were scheduled to undergo a site initiation visit by mid-April and all 26 sites are currently listed as actively recruiting on www.clinicaltrials.gov.
We model randomisation peaking at 33 per month
We routinely model recruitment rates in clinical trials steadily increasing as sites become fully active. Subjects who meet the recruitment criteria in the current trial are screened via two weeks of standard compression therapy – patients with evidence of spontaneous healing or severe deterioration are excluded and do not proceed to randomisation. Twenty-two patients entered screening from 11 sites in March. Using this average of two per site per month across 26 sites, we assume peak recruitment of 50 entering screening per month by July. Based on the 67% (12/18) screening pass rate to date, we assume that 33 patients will be randomised to VF-001 or placebo per month. Combining these assumptions with the 12 patients randomised as at end-March, we model the trial being fully recruited by September.
Valuation: Unchanged at A$108m or A$0.15 per share
Our valuation is unchanged at A$108m or A$0.15 per share. Although top-line data in Q118 would represent slight slippage on the company’s target of a read-out in Q417, it would leave intact our key valuation assumptions of an out-licensing deal in FY19, launch in Europe in FY20 and a US launch in FY22. The A$12.7m cash balance at 31 December 2016 should be sufficient to fund operations beyond the reporting date for the key Phase IIb trial.
Exhibit 1: Financial summary
|
A$000s |
2014 |
2015 |
2016 |
2017e |
2018e |
|
Year end 30 June |
AASB |
AASB |
AASB |
AASB |
AASB |
||
PROFIT & LOSS |
|||||||
Sales, royalties, milestones |
0 |
0 |
0 |
0 |
0 |
||
Other (includes R&D tax rebate) |
518 |
355 |
435 |
2,640 |
1,840 |
||
Revenue |
|
|
518 |
355 |
435 |
2,640 |
1,840 |
R&D expenses |
(1,018) |
(2,529) |
(2,005) |
(6,600) |
(4,600) |
||
SG&A expenses |
(6,381) |
(4,946) |
(2,545) |
(1,827) |
(1,923) |
||
Other |
0 |
0 |
0 |
0 |
0 |
||
EBITDA |
|
|
(6,881) |
(7,120) |
(4,116) |
(5,787) |
(4,683) |
Operating Profit (before GW and except.) |
|
|
(6,964) |
(7,201) |
(4,159) |
(5,804) |
(4,705) |
Intangible Amortisation |
(68) |
(68) |
(68) |
(56) |
(50) |
||
Exceptionals |
0 |
(4,092) |
(7,486) |
0 |
0 |
||
Operating Profit |
(7,032) |
(11,361) |
(11,712) |
(5,860) |
(4,755) |
||
Net Interest |
217 |
155 |
101 |
431 |
204 |
||
Profit Before Tax (norm) |
|
|
(6,816) |
(7,114) |
(4,125) |
(5,429) |
(4,551) |
Profit Before Tax (reported) |
|
|
(6,816) |
(11,206) |
(11,611) |
(5,429) |
(4,551) |
Tax benefit |
(14) |
(13) |
(1) |
0 |
0 |
||
Profit After Tax (norm) |
(6,830) |
(7,127) |
(4,126) |
(5,429) |
(4,551) |
||
Profit After Tax (reported) |
(6,830) |
(11,219) |
(11,612) |
(5,429) |
(4,551) |
||
Average Number of Shares Outstanding (m) |
241.8 |
278.3 |
381.4 |
724.3 |
724.3 |
||
EPS - normalised (c) |
|
|
(2.82) |
(4.03) |
(3.04) |
(0.75) |
(0.63) |
EPS diluted (c) |
|
|
(2.82) |
(4.03) |
(3.04) |
(0.75) |
(0.63) |
Dividend per share (A$) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
|||||||
Fixed Assets |
|
|
9,314 |
8,392 |
1,326 |
1,293 |
1,261 |
Intangible Assets |
342 |
342 |
557 |
502 |
451 |
||
Tangible Assets |
8,970 |
8,048 |
769 |
791 |
809 |
||
Investments |
2 |
2 |
0 |
0 |
0 |
||
Current Assets |
|
|
9,519 |
6,814 |
15,121 |
9,725 |
5,206 |
Stocks |
1,530 |
649 |
34 |
0 |
0 |
||
Debtors |
184 |
120 |
201 |
2,407 |
1,607 |
||
Cash |
7,077 |
5,579 |
14,376 |
6,808 |
3,090 |
||
Other |
728 |
466 |
510 |
510 |
510 |
||
Current Liabilities |
|
|
(1,777) |
(1,806) |
(881) |
(881) |
(881) |
Creditors |
(1,247) |
(1,630) |
(710) |
(710) |
(710) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
||
Other |
(530) |
(175) |
(172) |
(172) |
(172) |
||
Long Term Liabilities |
|
|
(196) |
(75) |
(45) |
(45) |
(45) |
Long term borrowings |
0 |
0 |
0 |
0 |
0 |
||
Other long term liabilities |
(196) |
(75) |
(45) |
(45) |
(45) |
||
Net Assets |
|
|
16,860 |
13,325 |
15,520 |
10,091 |
5,541 |
CASH FLOW |
|||||||
Operating Cash Flow |
|
|
(7,669) |
(9,650) |
(5,263) |
(7,958) |
(3,883) |
Net Interest |
173 |
214 |
115 |
431 |
204 |
||
Tax |
422 |
392 |
413 |
0 |
0 |
||
Capex |
(17) |
(5) |
(221) |
(40) |
(40) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
0 |
||
Equity Financing |
10,120 |
8,258 |
14,751 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
||
Other |
(804) |
(671) |
(982) |
0 |
0 |
||
Net Cash Flow |
2,224 |
(1,463) |
8,813 |
(7,567) |
(3,719) |
||
Opening net debt/(cash) |
|
|
(4,862) |
(7,077) |
(5,579) |
(14,376) |
(6,808) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
||
Other |
(9) |
(36) |
(16) |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(7,077) |
(5,579) |
(14,376) |
(6,808) |
(3,090) |
Source: Factor Therapeutics data, Edison Investment Research
|
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