A licensing deal for Pascomer

AFT Pharmaceuticals 10 July 2019 Update
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AFT Pharmaceuticals

A licensing deal for Pascomer

Development update

Pharma & biotech

10 July 2019

Price

NZ$3.19

Market cap

NZ$310m

NZ$0.65/US$

Net debt (NZ$m) at 31 March 2019

34.8

Shares in issue

97.3m

Free float

21.6%

Code

AFT

Primary exchange

NZX

Secondary exchange

ASX

Share price performance

%

1m

3m

12m

Abs

6.3

64.4

32.4

Rel (local)

1.6

53.5

17.8

52-week high/low

NZ$3.19

NZ$1.70

Business description

AFT Pharmaceuticals is a specialty pharmaceutical company that operates primarily in Australasia but has product distribution agreements across the globe. The company’s product portfolio includes prescription and over-the-counter drugs to treat a range of conditions and a proprietary nebuliser.

Next events

Additional Maxigesic launches

2019

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

AFT Pharmaceuticals is a research client of Edison Investment Research Limited

AFT Pharmaceuticals has reported a North American licensing deal for Pascomer, a topical formulation of rapamycin being developed for facial angiofibromas in tuberous sclerosis complex (TSC), to private US-based Timber Pharmaceuticals. Timber will fund clinical development and provide AFT with over US$10m in upfront, development and regulatory milestones, as well as over US$10m in sales milestone payments and royalties. An Investigational New Drug Application has been approved by the FDA. The first of two 120-patient clinical studies is expected to start shortly, with results in 2020.

Year end

Revenue (NZ$m)

PBT*
(NZ$m)

EPS*
(NZ$)

DPS
(NZ$)

P/E
(x)

Yield
(%)

03/18

81.2

(12.9)

(0.13)

0.0

N/A

N/A

03/19

85.1

(2.5)

(0.03)

0.0

N/A

N/A

03/20e

99.9

6.4

0.07

0.0

45.6

N/A

03/21e

119.5

17.6

0.18

0.0

17.7

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

An attractive orphan market

According to the US National Institute of Neurological Disorders and Stroke, TSC affects between 25,000 and 40,000 Americans and one to two million people worldwide. Angiofibromas, which can be highly disfiguring, affect around 80% of patients with TSC. Current therapies are typically surgical, such as chemical peeling, excision and laser surgery.

Evidence of rapamycin efficacy

Oral rapamycin was first approved in 1999 for immunosuppressant use. Initial evidence of its potential efficacy in angiofibromas occurred in a patient who initiated oral rapamycin because of renal transplantation and her facial angiofibromas improve markedly. A review of recent studies indicates that compounded topical formulations of rapamycin have improved lesions in 94% of subjects although there is no topical formulation available commercially.

A low-risk development plan for AFT

The licensing agreement with Timber allows AFT to retain some of the upside potential of Pascomer but without having to yield near- to medium-term profitability to fund its development. Timber will have full responsibility for R&D investment, while AFT will collect high-margin royalties if Pascomer is successfully developed.

Valuation: NZ$495m or NZ$5.09 per share

We are maintaining our valuation of NZ$495m or NZ$5.09 per share. To be conservative, we are not including Pascomer development in our estimates due to its early stage but we will revisit this as the programme progresses. Also, the company reiterated its operating profit target is between NZ$9m and NZ$12m for FY20.

Pascomer for facial angiofibromas in TSC

AFT has announced it has licensed Pascomer, which is being developed for facial angiofibromas in TSC patients, to Timber Pharmaceuticals for over US$10m in upfront, development and regulatory milestones, as well as over US$10m in sales milestone payments and royalties.

TSC is a multisystem, autosomal dominant genetic disorder resulting from a mutation in one of two tumour suppressor genes, TSC1 (encoding hamartin) or TSC2 (tuberin). TSC is characterised by benign tumours, known as hamartomas, in various organs, most commonly the skin, brain, kidneys, heart and lungs. A hamartoma is composed of an overgrowth of mature cells and tissues, which normally occurs in the affected tissue. TSC affects both sexes and all ethnic groups, affecting as many as 25,000–40,000 individuals in the US and one to two million individuals worldwide, with an estimated prevalence of one in 6,000 newborns according to the US National Institute of Neurological Disorders and Stroke. Angiofibromas, which can be highly disfiguring, affect around 80% of patients with TSC.

Pascomer is a topical version of rapamycin (marketed as Rapamune by Pfizer), an immunosuppressant used for prophylaxis of organ rejection in patients receiving kidney transplants. It is also approved for the treatment of lymphangioleiomyomatosis, a progressive disease often associated with TSC that results in lung destruction. Rapamycin is an inhibitor of mammalian target of rapamycin (mTOR), which has many functions in protein synthesis and cell growth and is aberrantly activated in patients with TSC, making it a logical target for development in the treatment of this disease.

Initial evidence of rapamycin’s potential efficacy in angiofibromas occurred in a patient who initiated oral rapamycin because of renal transplantation and her facial angiofibromas improve markedly.1 As rapamycin is a potent immunosuppressive, systemic exposure for the sake of improving facial angiofibromas is not ideal and there have been several small studies of topical rapamycin in this indication.

  Hofbauer et al. The mTOR inhibitor rapamycin significantly improves facial angiofibroma lesions in a patient with tuberous sclerosis. British Journal of Dermatology 2008 159, pp. 473–475

According to one review, 94% of the 84 patients treated with a topical rapamycin in various studies showed improvement in their lesions.2 In the one randomised, double-blind, placebo-controlled study (with 23 subjects) in the review, 73% of the subjects who received treatment reported a subjective improvement in their angiofibromas compared to 38% in placebo although the p value was not significant (p=0.18), likely because of the size of the study.3 Importantly, although a variety of different topical formulations were used, rapamycin was detected in only three patients out of the 74 tested for serum rapamycin levels, indicating a lack of systemic exposure. However, one of the issues with the various topical formulations used in these studies is that stability is limited. AFT believes it has developed a formulation using a proprietary dermal delivery technology that would be stable and hence commercially viable.

  Balestri et al., Analysis of current data on the use of topical rapamycin in the treatment of facial angiofibroma in Tuberous Sclerosis Complex. Journal of the European Academy of Dermatology and Venereology. 2015, 29, 14–20

  Koenig et al. Topical rapamycin therapy to alleviate the cutaneous manifestations of tuberous sclerosis complex. Drugs in R&D 2012 Sep: 12(3): 121–126

For intellectual property, there are no unexpired patents related to Rapamune in the FDA Orange Book so AFT appears to be free to operate. We do not know the extent of the patent estate for Pascomer but at the very least it will be eligible for orphan drug exclusivity, which is seven years in the United States and 10 years’ worth of data exclusivity in the EU (although we would expect patent coverage to go well beyond that due to the proprietary nature of the formulation).

As part of the agreement, Timber will cover the clinical trial costs associated with clinical development. An Investigational New Drug Application has already been approved by the FDA with the first of two 120-patient clinical studies expected to start shortly in eight centres in the US (the Mayo Clinic), Australia, New Zealand, Spain and the UK. Results are expected in 2020.

Valuation

We are maintaining our valuation of NZ$495m or NZ$5.09 per share as Pascomer development is too early stage to include in our estimates. We will revisit this as the programme progresses.

Exhibit 1: DCF sensitivity table (NZ$/share)

Terminal EBIT margin

Terminal revenue growth

30.00%

34.00%

36.0%

40.0%

45.0%

-2%

3.42

3.71

3.85

4.14

4.50

-1%

3.60

3.92

4.08

4.39

4.79

0%

3.83

4.17

4.35

4.69

5.13

1%

4.10

4.48

4.68

5.06

5.54

2%

4.44

4.87

5.09

5.52

6.06

3%

4.87

5.37

5.62

6.11

6.73

4%

5.45

6.03

6.32

6.90

7.62

5%

6.27

6.96

7.30

8.00

8.86

Source: Edison Investment Research

Financials

We are maintaining our financial estimates as the precise size of the upfront payment is undisclosed. Also, the company has reiterated its operating profit target of between NZ$9m and NZ$12m for FY20.

Exhibit 2: Financial summary

NZ$000

2018

2019

2020e

2021e

March

NZ GAAP

NZ GAAP

NZ GAAP

NZ GAAP

PROFIT & LOSS

Revenue

 

 

 

81,176

85,127

99,947

119,505

Cost of Sales

(45,880)

(44,397)

(51,547)

(56,407)

Gross Profit

35,296

40,730

48,400

63,098

EBITDA

 

 

 

(10,479)

5,797

10,288

21,447

Operating Profit (before amort. and except.)

 

(10,353)

5,912

10,403

21,562

Intangible Amortisation

214

204

204

204

Exceptionals

0

0

0

0

Other

(364)

1,716

1,802

1,892

Operating Profit

(10,503)

7,832

12,409

23,658

Net Interest

(2,527)

(8,375)

(4,000)

(4,000)

Profit Before Tax (norm)

 

 

 

(12,880)

(2,463)

6,403

17,562

Profit Before Tax (reported)

 

 

 

(12,666)

(2,259)

8,409

19,658

Tax

(58)

(168)

0

0

Profit After Tax (norm)

(12,938)

(2,631)

6,403

17,562

Profit After Tax (reported)

(12,724)

(2,427)

8,409

19,658

Average Number of Shares Outstanding (m)

97.2

97.3

97.3

97.3

EPS - normalised (NZ$)

 

 

 

(0.13)

(0.03)

0.07

0.18

EPS - (reported) (NZ$)

 

 

 

(0.14)

(0.03)

0.09

0.20

Dividend per share (c)

0.00

0.00

0.00

0.00

Gross Margin (%)

43.5

47.8

48.4

52.8

EBITDA Margin (%)

N/A

6.8

10.3

17.9

Operating Margin (before GW and except.) (%)

N/A

6.9

10.4

18.0

BALANCE SHEET

Fixed Assets

 

 

 

8,291

12,334

15,540

18,785

Intangible Assets

5,118

8,239

11,245

14,366

Tangible Assets

330

357

557

681

Investments

2,843

3,738

3,738

3,738

Current Assets

 

 

 

48,312

51,261

53,543

69,382

Stocks

24,412

25,158

27,958

30,594

Debtors

16,954

19,187

17,474

19,121

Cash

6,946

6,916

8,112

19,667

Other

0

0

0

0

Current Liabilities

 

 

 

(18,607)

(58,504)

(15,249)

(16,567)

Creditors

(18,489)

(16,368)

(15,249)

(16,567)

Short term borrowings

0

(41,750)

0

0

Long Term Liabilities

 

 

 

(30,654)

0

(41,750)

(41,750)

Long term borrowings

(30,654)

0

(41,750)

(41,750)

Other long term liabilities

0

0

0

0

Net Assets

 

 

 

7,342

5,091

12,084

29,850

CASH FLOW

Operating Cash Flow

 

 

 

(6,582)

9,610

8,721

19,120

Net Interest

(4,264)

(8,375)

(4,000)

(4,000)

Tax

(58)

(168)

0

0

Capex

(2,853)

(3,465)

(3,525)

(3,564)

Acquisitions/disposals

(3,002)

(1,419)

0

0

Financing

877

0

0

0

Dividends

(412)

(134)

0

0

Net Cash Flow

(16,294)

(3,951)

1,196

11,556

Opening net debt/(cash)

 

 

 

7,446

23,708

34,834

33,638

HP finance leases initiated

0

0

0

0

Other

32

(7,175)

(0)

0

Closing net debt/(cash)

 

 

 

23,708

34,834

33,638

22,083

Source: Edison Investment Research, company accounts


General disclaimer and copyright

This report has been commissioned by AFT Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by AFT Pharmaceuticals. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

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Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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.

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New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

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Frankfurt +49 (0)69 78 8076 960

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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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by AFT Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by AFT Pharmaceuticals. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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.

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Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, 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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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