Factor Therapeutics — Recruitment in VLU Phase IIb expected to build

Factor Therapeutics — Recruitment in VLU Phase IIb expected to build

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.

Analyst avatar placeholder

Written by

Factor Therapeutics

Recruitment in VLU Phase IIb expected to build

Clinical trial update

Pharma & biotech

17 May 2017

Price

A$0.06

Market cap

A$46m

US$0.76/A$

Net cash (A$m) at 31 March 2017

10.2

Shares in issue

730.0m

Free float

92%

Code

FTT

Primary exchange

ASX

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

0.0

3.3

85.3

Rel (local)

0.7

2.9

70.7

52-week high/low

A$0.1

A$0.0

Business description

Factor Therapeutics is an Australian biotechnology company that specialises in the development and manufacture of biologics for advanced wound care applications. Its strategy is to use targeted growth factors to renew the wound environment and promote healing.

Next events

Update on recruitment in VLU Phase IIb

End Q217

Update on DFU IND preparations

End-May 2017

Top-line results VLU Phase IIb

Q118

Analysts

Dennis Hulme

+61 (0)2 9258 1161

Lala Gregorek

+44 (0)20 3681 2527

Factor Therapeutics is a research client of Edison Investment Research Limited

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
end

Revenue
(A$m)

PBT*
(A$m)

EPS*
(c)

DPS*
(c)

P/E
(x)

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

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Factor Therapeutics and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205, 95 Pitt Street

Sydney , NSW 2000

Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205, 95 Pitt Street

Sydney , NSW 2000

Australia

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Factor Therapeutics and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205, 95 Pitt Street

Sydney , NSW 2000

Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205, 95 Pitt Street

Sydney , NSW 2000

Australia

Research: Investment Companies

TR European Growth Trust — Strong returns from European small-cap specialist

TR European Growth Trust (TRG) has enjoyed an exceptionally strong period of recent share price and NAV performance, posting gains of c 50% over 12 months to 30 April. While returns from all overseas investments have been boosted by the weakness of sterling since the UK’s Brexit referendum, TRG’s outperformance has been assisted by a focus on better-value cyclical stocks, and the decision of lead manager Ollie Beckett to increase gearing in the second half of 2016. The trust invests in European (ex-UK) smaller companies, with a particular focus on those at the lower end of the market cap spectrum, where both rewards and risks may be higher. Because of this, TRG has a longer stock list than peers. While the discount to NAV has narrowed somewhat, it remains at c 9% compared with an average of 0.7% for the investment company universe.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free