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Treakisym label expansion submitted

SymBio Pharmaceuticals 22 May 2020 Update
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SymBio Pharmaceuticals

Treakisym label expansion submitted

Earnings and regulatory update

Pharma & biotech

22 May 2020

ADR research

Price

$4.33*

Market cap

$148m

*Underlying ¥ price converted at ¥110/US$ ADR/Ord conversion ratio 1:1

*

Net cash ($m) at 31 March 2020 + subsequent exercises

50.8

ADRs in issue

34.1m

ADR code

SYMQY

ADR exchange

OTC

Underlying exchange

Tokyo

Depository

BNY

Business description

SymBio Pharmaceuticals is a Japanese specialty pharma company with a focus on oncology and hematology. The Treakisym powder formulation was in-licensed from Astellas in 2005; liquid Treakisym was in-licensed from Eagle Pharmaceuticals in 2017. Rigosertib was in-licensed from Onconova. And brincidofovir was licensed from Chimerix in 2019.

Next events

Rigosertib Phase III results

H220

Treakisym RTD approval decision

October 2020

Analyst

Nathaniel Calloway

+1 646 653 7036

SymBio Pharmaceuticals is a research client of Edison Investment Research Limited

SymBio announced on 11 May 2020 that it submitted an application to expand the label for Treakisym in Japan to include the treatment of relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with rituximab. This follows the positive results seen in the Phase III study for the combination reported in November 2019. We expect this label expansion to more than double the sales potential for the drug.

Year end

Revenue ($m)

PTP*
($m)

EPADR
($)

DPADR
($)

P/E
(x)

Gross yield
(%)

12/18

34.8

(24.9)

(1.50)

0.0

N/A

N/A

12/19

25.7

(39.7)

(1.72)

0.0

N/A

N/A

12/20e

23.7

(47.7)

(1.65)

0.0

N/A

N/A

12/21e

83.8

9.9

0.17

0.0

N/A

N/A

Note: Converted at **/US$. Dividend yield excludes withholding tax. Investors should consult their tax advisor regarding the application of any domestic and foreign tax laws.

DLBCL key to future growth

Treakisym (bendamustine) is currently approved in Japan for low-grade non-Hodgkin lymphoma (NHL) or mantle cell lymphoma and chronic lymphocytic leukemia. We estimate the label expansion would approximately double the target market with 11,200 second-line DLBCL patients. While the company did not publish detailed results from its Phase III study, it reported that it met its primary endpoints and the combination has established efficacy in the literature.

Label expansion part of multi-pronged strategy

The label expansion is one aspect of the company’s ongoing strategy to reach profitability. The drug is currently sold by Eisai, with SymBio regaining full control at the end of 2020, after which the product will be sold by an internal salesforce. The company has also licensed the rights to two proprietary formulations of bendamustine from Eagle Pharmaceuticals and plans to convert providers to the new, more convenient formulations prior to the October 2020 loss of exclusivity for the current formulation.

Supply issues continue to affect sales, margins

The company reported with Q120 results that quality control issues of Treakisym sourced from Astellas have continued to affect the ability of the company to deliver product to Eisai. This problem has persisted since mid-2019. The company reported revenue of $5.0m for the quarter, down from $15.0m for Q119, and a gross profit of $1.2m (down from $5.7m), citing lack of inventory as the cause.

Valuation: Increased to $354.2m

We have increased our valuation to $354m (¥39.0bn) from $338m (¥37.2bn) previously, although it is lower on a per share basis: $10.40 (¥1,144) from $12.28 (¥1,351). We estimate a cash balance of $50.8m following multiple recent rights exercises ($15.5m raised since Q120 cash of $35.3m). We expect this to be sufficient for the company to deliver on its strategy to reach profitability in 2021.

Treakisym DLBCL label expansion submitted

SymBio announced in May 2020 that it had completed and submitted its application to the PMDA to expand the addressable indications for Treakisym to include relapsed and refractory DLBCL (in combination with rituximab). SymBio previously announced that it had met is primary endpoint in its Phase III study of Treakisym (bendamustine). The primary endpoint was overall response rate, with progression free survival and overall survival as secondary endpoints, but a detailed report was not presented. The study was open label and single arm, but this may be able to support a label expansion for the drug to this indication considering the well-demonstrated activity in other studies. Although bendamustine is not approved explicitly for DLBCL in the US (although it is approved for indolent NHL), it has been demonstrated to have activity when combined with rituximab,1 similar to the company’s pivotal study. The company previously announced an overall response rate (ORR) of 62.7% and complete response (CR) of 37.3% was observed in the earlier Phase II study. We estimate a target market of 11,200 second-line DLBCL patients in Japan, which would approximately double the current addressable market. We expect an approval decision from the PMDA within 12 months.

  Arcari A. et al. (2014) Safety and Efficacy of Rituximab Plus Bendamustine in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients. Blood 124, 3074.

Frustrating quality control issues continue

The quality control issues the company has experienced with shipments of bendamustine from its supplier Astellas continue unabated. This has significantly affected the ability of the company to deliver drug to Eisai and the associated revenue from that agreement. The company reported revenue of $5.0m for Q1 (Q119: $15.0m), and a gross profit of $1.2m (Q119: $5.7m).

This has been an issue since mid-2019, which the company first identified quality issues in shipments of drug from Astellas. SymBio has repeatedly sought to resolve the issue, but apparently to no effect. We have lost confidence that this issue can be resolved in a timely manner and have reduced our forecasted revenue for 2020 to $23.7m from $31m previously, and our gross profit to $5.9m from $9.4m.

However, the company has planned to transition to using the formulations licensed from Eagle once they are approved. We expect a decision on the approval of the ready-to-dilute (RTD) formulation by the end of September 2020.

Valuation

We have increased our valuation to $354m (¥39.0bn) from $338m (¥37.2bn) previously, although it is lower on a per share basis: $10.40 (¥1,144) from $12.28 (¥1,351). The increase in total valuation is from rolling forward our NPVs. Although we now forecast lower revenue in 2020 than previously, this impact is limited to the current year (FY20), dampening the overall effect on the valuation. The increase in shares outstanding is driven by the recent large rights exercises in the ongoing rights offering: 5.61m new shares to date in April and May, bringing the total outstanding to an estimated 34.1m. We expect to update our valuation with the top-line results from the Phase III study of rigosertib (in development at and licensed from Onconova) expected in H220 (delayed from H120 previously).

Exhibit 1: Valuation of SymBio

Product

Indication

Launch

Peak Sales ($m)

Value ($m)

Probability

rNPV ($m)

NPV/ADR ($/ADR)

Treakisym

Low grade NHL/MCL (r/r and 1st line); CLL

2010

78

177.9

100-95%

170.2

5.00

Treakisym (DLCBL)

r/r DLBCL

2021

87

121.7

90%

108.9

3.20

Rigosertib (IV)

r/r HR-MDS

2023

35

26.4

50%

12.4

0.36

Rigosertib (oral)

LR-MDS (mono) or First-line HR-MDS (combo)

2025

68

39.1

15%

4.0

0.12

Brincidofovir

vHC

2025

38

30.8

30%

8.0

0.24

Net Cash (March 2020 + subseuqent exercises)

50.8

100%

50.8

1.49

Valuation

 

 

 

446.7

 

354.2

10.40

Source: SymBio Pharmaceuticals reports, Edison Investment Research

Financials

The company ended the quarter with $35.3m and subsequently raised $15.5m in equity through rights exercises. We expect this to be sufficient cash for the company to continue its commercial buildout in preparation for the 2021 relaunch of Treakisym, and we expect sustained profitability thereafter. We previously included $5.5m in additional capital needed to provide a cash buffer going into the launch, which has been removed given the raised cash. Other changes to our forecasts (besides those described above) include adjusting 2020 SG&A spending ($30m from $32m), other minor changes to reflect Q120 results, and an update to our tax treatment to align better with Japanese GAAP and tax law changes. We have slightly increased 2021 expected revenue ($84m from $83m) to reflect warehoused patients unable to get treatment with the current supply issues.

Exhibit 1: Financial summary

Accounts: JPN GAAP, year end: 31 December, $'000s

 

 

2018

2019

2020e

2021e

Total revenues

 

 

34,868

25,798

23,710

83,889

Cost of sales

 

 

(24,206)

(17,936)

(17,782)

(14,716)

Gross profit

 

 

10,662

7,861

5,927

69,173

SG&A (expenses)

 

 

(18,147)

(24,771)

(30,226)

(52,477)

R&D costs

 

 

(16,661)

(22,196)

(23,664)

(6,955)

Other income/(expense) included in adjusted

 

 

0

0

0

0

Other income/(expense) excluded from adjusted

 

 

0

0

0

0

Reported EBIT

 

 

(24,146)

(39,106)

(47,962)

9,742

Finance income/ (expense)

 

 

6

2

178

171

Other income/(expense) included in adjusted

 

 

(0)

38

0

0

Other income/(expense) excluded from adjusted

 

 

(848)

(684)

0

0

Reported PBT

 

 

(24,988)

(39,750)

(47,784)

9,913

Income tax expense

 

 

(35)

(35)

(35)

(3,973)

Reported net income

 

 

(25,023)

(39,784)

(47,818)

5,940

Average number of ADRs - basic (m)

 

 

16.6

23.2

29.0

34.1

Basic Earnings per ADR

USD

 

(1.50)

(1.72)

(1.65)

0.17

 

 

 

 

 

 

 

Adjusted EBITDA

 

 

(23,831)

(3,876)

(4,708)

1,059

Adjusted EBIT

 

 

(24,146)

(3,911)

(4,796)

974

Adjusted PBT

 

 

(24,988)

(3,979)

(4,778)

991

Adjusted Earnings per ADR

USD

 

(1.50)

(1.72)

(1.65)

0.17

Adjusted diluted Earnings per ADR

USD

 

(1.50)

(1.72)

(1.65)

0.17

 

 

 

 

 

 

 

BALANCE SHEET

 

 

 

 

 

 

Property, plant and equipment

 

 

518

686

730

1,237

Goodwill

 

 

0

0

0

0

Intangible assets

 

 

649

2,187

1,918

1,738

Other non-current assets

 

 

660

640

640

640

Total non-current assets

 

 

1,827

3,513

3,288

3,615

Cash and equivalents

 

 

43,831

35,553

17,044

16,865

Inventories

 

 

4,853

0

1,997

1,653

Trade and other receivables

 

 

3,743

4,993

2,598

9,193

Other current assets

 

 

2,469

3,885

3,885

3,885

Total current assets

 

 

54,895

44,432

25,525

31,596

Non-current loans and borrowings

 

 

0

0

0

0

Trade and other payables

 

 

0

0

0

0

Other non-current liabilities

 

 

12

15

15

15

Total non-current liabilities

 

 

12

15

15

15

Trade and other payables

 

 

6,601

1,099

4,357

4,815

Current loans and borrowings

 

 

0

0

0

0

Other current liabilities

 

 

5,548

6,830

6,830

6,830

Total current liabilities

 

 

12,149

7,929

11,187

11,645

Equity attributable to company

 

 

44,562

40,001

17,612

23,552

Non-controlling interest

 

 

0

0

0

0

 

 

 

 

 

 

 

CASHFLOW STATEMENT

 

 

 

 

 

 

Profit before tax

 

 

(24,988)

(39,750)

(47,784)

9,913

Depreciation and Amortisation

 

 

315

346

882

849

Share based payments

 

 

1,342

0

0

0

Other adjustments

 

 

552

2,081

(178)

(171)

Movements in working capital

 

 

1,677

(2,201)

3,655

(5,792)

Net cash from operating activities (pre-tax)

 

 

(21,102)

(39,523)

(43,425)

4,799

Interest paid / received

 

 

5

5

178

171

Income taxes paid

 

 

(35)

(35)

(35)

(3,973)

Cash from operations (CFO)

 

 

(21,132)

(39,552)

(43,281)

997

Capex

 

 

(362)

(1,968)

(656)

(1,176)

Acquisitions & disposals net

 

 

0

0

0

0

Other investing activities

 

 

124

0

0

0

Cash used in investing activities (CFIA)

 

 

(238)

(1,968)

(656)

(1,176)

Net proceeds from issue of shares

 

 

38,837

33,982

25,429

0

Movements in debt

 

 

0

0

0

0

Other financing activities

 

 

0

19

0

0

Cash from financing activities (CFF)

 

 

38,837

34,000

25,429

0

Currency translation differences and other

 

 

(428)

(758)

0

0

Increase/(decrease) in cash and equivalents

 

 

17,039

(8,278)

(18,509)

(179)

Cash and equivalents at end of period

 

 

43,831

35,553

17,044

16,865

Net (debt) cash

 

 

43,831

35,553

17,044

16,865

Movement in net (debt) cash over period

 

 

17,039

(8,278)

(18,509)

(179)

Source: SymBio Pharmaceuticals reports, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by SymBio Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by SymBio 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

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Germany

London +44 (0)20 3077 5700

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New York +1 646 653 7026

1,185 Avenue of the Americas

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United States of America

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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 SymBio Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by SymBio 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

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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