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A TGA approval and a capital raise

Suda Pharmaceuticals 3 September 2020 Update
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SUDA Pharmaceuticals

A TGA approval and a capital raise

Financial update

Pharma & biotech

3 September 2020

Price

A$0.05

Market cap

A$15m

A$1.35/US$

Net cash (A$m) at 30 June 2020 + offering

5.1

Shares in issue

305.8m

Free float

97.2%

Code

SUD

Primary exchange

ASX

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

2.2

32.1

(26.0)

Rel (local)

(1.1)

25.9

(21.0)

52-week high/low

A$0.10

A$0.03

Business description

SUDA Pharmaceuticals has historically been a drug delivery company focusing on developing oro-mucosal spray versions of established medicines. It has the rights to ZolpiMist, the spray version of Ambien for insomnia, outside of North America. SUDA is also working on formulating an oro-mucosal version of anagrelide for the treatment of solid tumours, sumatriptan for migraine, cannabinoids for various conditions, as well as other projects.

Next events

Additional licensing deals

FY21

Analysts

Maxim Jacobs

+1 646 653 7027

Wiktoria O’Hare

+1 646 653 7028

SUDA Pharmaceuticals is a research client of Edison Investment Research Limited

SUDA has had a busy couple of months, announcing approval for ZolpiMist in Australia by the Therapeutics Goods Administration (TGA) in July, as well as raising A$4.1m in additional capital. The TGA approval demonstrates SUDA’s compliance with Good Manufacturing Practice (GMP) as well as an ability to obtain regulatory approvals. This approval will assist SUDA’s current partners in their submissions in the territories for which they are responsible.

Year end

Revenue (A$m)

PBT*
(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/19

1.2

(2.4)

(0.02)

0.0

N/A

N/A

06/20

0.5

(4.7)

(0.03)

0.0

N/A

N/A

06/21e

0.6

(5.5)

(0.02)

0.0

N/A

N/A

06/22e

1.1

(5.6)

(0.02)

0.0

N/A

N/A

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

TGA approval for ZolpiMist

ZolpiMist is an oro-mucosal spray version of Ambien, which has a faster onset than the pill form. SUDA had submitted a marketing authorisation application (MAA) to the TGA in April 2019 for ZolpiMist in Australia. It had most recently expected completion of the TGA review in Q4 CY20, so approval in July comes a few months ahead of schedule.

Commercialising ZolpiMist globally

SUDA has the rights outside North America and has out-licensed rights in Mexico, Brazil and Chile to Teva, and in Singapore, Malaysia, the Philippines and Korea to Mitsubishi Tanabe. Royalties are typically double digit and include a handling fee. The TGA approval will assist SUDA’s current partners in their submissions in the territories for which they are responsible.

A$4.1m in additional capital

SUDA conducted an entitlement offer in which eligible shareholders were able to subscribe for one new share at A$0.025 for each share currently held, and one option for each three shares subscribed for. Through this, A$3.6m in gross proceeds was raised. Due to the high demand for shares in the entitlement offer, the company subsequently raised an additional A$0.5m via a private placement.

Valuation: A$24m or A$0.08 per basic share

We have adjusted our valuation for SUDA to A$24m or A$0.08 per basic share (A$0.06 per diluted share) from A$18m or A$0.13 per basic share (A$0.09 per diluted share). The total valuation has increased due to higher net cash and rolling forward our NPV, while the per-share value has decreased due to a greater number of shares outstanding. The company had A$1.0m in cash on hand at 30 June 2020 and raised an additional A$4.1m. After taking into account the recent raise, we estimate the need to raise an additional A$6m in FY21 (A$18.5m total over the next three years) to fund operations based on the current business plan.

FY20 results

ZolpiMist is the oro-mucosal spray version of zolpidem tartrate (the branded form is the blockbuster insomnia drug Ambien), which has 30m prescriptions written for it in the US annually. Approximately 2.5m prescriptions are written for novel formulations, such as controlled release and sublingual tablets. The main benefit of ZolpiMist is the fast onset of action. Therapeutic levels were reached within 15 minutes following administration of the 10mg dose of ZolpiMist in 79% of patients compared to only 26% with the tablet version.1

  Neubauer et al., ZolpiMist: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US. Nature and Science of Sleep 2010:2 79–84.

ZolpiMist has been approved in the US since 2008 (where Aytu BioScience has the rights) and this approval in Australia is the first outside the US and the first by SUDA. SUDA has out-licensed ZolpiMist to Teva for Mexico, Chile and Brazil, and to two separate divisions of Mitsubishi Tanabe for Singapore, Malaysia, the Philippines and South Korea. While upfront payments have been small, the royalty rates are all double digit and SUDA will also receive a handling fee. The company has stated that it is in discussions for licensing deals for additional territories (SUDA has rights outside the US and Canada), in line with the strategy of commercialising the product globally.

Exhibit 1: ZolpiMist licensing deals

Partner

Countries

Populations

Terms

Comments

Teva

Mexico, Chile and Brazil

Mexico: 123m, Chile: 17m,
Brazil: 213m

US$300,000 upfront, commercial milestones of US$700,000 and double-digit royalties

Agreement signed in 2017. Teva is currently working on approval in the three countries, launch timing undisclosed

Mitsubishi Tanabe Korea

South Korea

South Korea: 51m

US$100,000 upfront, US$100,000 on approval, up to US$300,000 in commercial milestones, a 12% royalty and a handling fee

Signed in 2020. Timing of approval and launch tbd

Mitsubishi Tanabe Singapore

Singapore, Malaysia, Philippines

Singapore: 6m, Malaysia: 32m, Philippines: 109m

US$100,000 upfront, US$770,000 in regulatory and commercial milestones, a double-digit royalty and a handling fee

Signed in 2018. Timing of approval and launch tbd

Source: SUDA Pharmaceuticals

Valuation

We have adjusted our valuation for SUDA to A$24m or A$0.08 per basic share (A$0.06 per diluted share) from A$18m or A$0.13 per basic share (A$0.09 per diluted share). The total valuation has increased due to higher net cash and rolling forward our NPV, while the per-share value has decreased due to a greater number of shares outstanding.

Exhibit 2: SUDA valuation table

Product

Main indication

Status

Probability of successful commercialisation

Approval year

Peak sales (A$m)

Economics

rNPV
(A$m)

ZolpiMist

Insomnia

Registered (Australia), pre-registration (other regions)

70%

2020

19.50

Double digit royalties

18.7

Total

 

 

 

 

 

 

18.7

Net cash (at 30 June 2020 + offering)

5.1

Total firm value (A$)

23.79

Total basic shares (m)

305.8

Value per basic share (A$)

0.08

Options (m)

68.1

Total number of shares (m)

374.0

Diluted value per share (A$)

0.06

Source: Edison Investment Research

Financials

For FY20, the company reported A$0.5m in revenue (down 56% compared to FY19, mainly due to the timing of licensing, upfront and milestone payments) and a loss of A$9.9m, although A$5.9m was due to intangible asset impairment related to ArTiMist. Operating cash burn for the year was A$2.9m. We have not made substantial changes to our FY21 estimates and introduce our FY22 estimates, which feature A$1.1m in revenues and include some ZolpiMist royalties flowing through.

SUDA had A$1.0m in cash on hand at 30 June 2020 and raised an additional A$4.1m after the end of the fiscal year. It raised A$3.6m in an entitlement offer through the issue of 142.3m shares and 47.4m listed options at a cost of A$0.025 per unit. The options expire on 31 July 2022 and have an exercise price of A$0.05. Due to the high demand seen in the entitlement offering, the company placed an additional 21.3m shares at A$0.025 per share with no additional options in a private placement, raising A$0.5m.

After taking into account the recent raise, we estimate the need to raise an additional A$6m in FY21 (A$18.5m total over the next three years) to fund operations based on the current business plan.

Exhibit 3: Financial summary

A$'000s

2019

2020

2021e

2022e

Year end 30 June

AIFRS

AIFRS

AIFRS

AIFRS

PROFIT & LOSS

Revenue

 

 

1,219

533

566

1,138

Cost of Sales

0

0

0

0

Gross Profit

1,219

533

566

1,138

Sales, General and Administrative Expenses

(3,129)

(4,788)

(4,979)

(5,178)

Research and Development Expense

0

0

(500)

(1,020)

EBITDA

 

 

(1,878)

(4,112)

(4,913)

(5,061)

Operating Profit (before amort. and except.)

 

 

(2,349)

(4,684)

(5,485)

(5,633)

Intangible Amortisation

0

0

0

0

Other

32

143

0

0

Exceptionals

(6,277)

(5,938)

0

0

Operating Profit

(8,626)

(10,622)

(5,485)

(5,633)

Net Interest

(94)

22

23

24

Other

0

0

0

0

Profit Before Tax (norm)

 

 

(2,443)

(4,662)

(5,462)

(5,609)

Profit Before Tax (FRS 3)

 

 

(8,720)

(10,600)

(5,462)

(5,609)

Tax

925

656

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(1,518)

(4,006)

(5,462)

(5,609)

Profit After Tax (FRS 3)

(7,795)

(9,944)

(5,462)

(5,609)

Average Number of Shares Outstanding (m)

98.6

142.3

306.0

309.1

EPS - normalised ($)

 

 

(0.02)

(0.03)

(0.02)

(0.02)

EPS - Reported ($)

 

 

(0.08)

(0.07)

(0.02)

(0.02)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

10,658

4,673

4,941

5,215

Intangible Assets

10,291

4,251

4,384

4,517

Tangible Assets

367

365

500

641

Other

0

57

57

57

Current Assets

 

 

5,595

2,035

6,618

8,792

Stocks

45

22

22

22

Debtors

1,121

869

913

114

Cash

4,314

977

5,517

8,490

Other

115

166

166

166

Current Liabilities

 

 

(1,349)

(2,022)

(1,677)

(1,677)

Creditors

(1,312)

(2,010)

(1,677)

(1,677)

Short term borrowings

(36)

(12)

0

0

Long Term Liabilities

 

 

(927)

(550)

(6,724)

(14,225)

Long term borrowings

(17)

(4)

(6,178)

(13,678)

Other long-term liabilities

(910)

(545)

(546)

(546)

Net Assets

 

 

13,978

4,135

3,157

(1,895)

CASH FLOW

Operating Cash Flow

 

 

(2,495)

(2,884)

(5,160)

(4,127)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(1,384)

(388)

(394)

(400)

Acquisitions/disposals

0

0

0

0

Financing

8,095

0

4,093

0

Dividends

0

0

0

0

Other

0

0

0

0

Net Cash Flow

4,215

(3,272)

(1,460)

(4,527)

Opening net debt/(cash)

 

 

1,951

(4,260)

(961)

661

HP finance leases initiated

0

0

0

0

Exchange rate movements

0

0

0

0

Other

1,996

(27)

(162)

(162)

Closing net debt/(cash)

 

 

(4,260)

(961)

661

5,350

Source: Edison Investment Research, company reports


General disclaimer and copyright

This report has been commissioned by SUDA Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by SUDA 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 2020 Edison Investment Research Limited (Edison).

Australia

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

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

1185 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

1185 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 SUDA Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by SUDA 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 2020 Edison Investment Research Limited (Edison).

Australia

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

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

1185 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

1185 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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