SymBio Pharmaceuticals — Now with commercial operations

SymBio Pharmaceuticals (TYO: 4582)

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Research: Healthcare

SymBio Pharmaceuticals — Now with commercial operations

SymBio will be undergoing a major transition in 2021 as it takes back the reigns to its Treakisym (bendamustine) franchise. The company will be making it first efforts to market the product line internally in Japan following the return of the rights from Eisai in December 2020. We expect these efforts to be bolstered by the recent launch of the ready-to-dilute (RTD) formulation of the product and the upcoming approval decision for diffuse large B-cell lymphoma (DLBCL) in May 2021.

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Written by

Healthcare

SymBio Pharmaceuticals

Now with commercial operations

Earnings update

Pharma & biotech

8 March 2021

Price

¥1,034

Market cap

¥39,499m

¥110/US$

Net cash (¥m) at 30 December 2020

3.85

Shares in issue

38.2m

Free float

91%

Code

4582

Primary exchange

TYO

Secondary exchange

OTC US

Share price performance

%

1m

3m

12m

Abs

15.5

163.1

148.0

Rel (local)

15.2

146.4

98.2

52-week high/low

¥1,460

¥264

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; and brincidofovir was licensed from Chimerix in 2019.

Next events

Treakisym DLBCL approval decision

H121

Treakisym RI application

2021

Analyst

Nathaniel Calloway

+1 646 653 7036

SymBio Pharmaceuticals is a research client of Edison Investment Research Limited

SymBio will be undergoing a major transition in 2021 as it takes back the reigns to its Treakisym (bendamustine) franchise. The company will be making it first efforts to market the product line internally in Japan following the return of the rights from Eisai in December 2020. We expect these efforts to be bolstered by the recent launch of the ready-to-dilute (RTD) formulation of the product and the upcoming approval decision for diffuse large B-cell lymphoma (DLBCL) in May 2021.

Year end

Revenue (¥m)

PBT*
(¥m)

EPS*
(¥)

DPS
(¥)

P/E
(x)

Yield
(%)

12/19

2,838

(4,250)

(184)

0

N/A

N/A

12/20

2,987

(4,514)

(137)

0

N/A

N/A

12/21e

9,228

1,508

27

0

38

N/A

12/22e

11,484

2,017

37

0

28

N/A

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

2021 goals: Relaunch Treakisym internally

In 2020 SymBio laid the groundwork for the transfer of Treakisym marketing rights through the establishment of its own sales team and other necessary infrastructure. The company has hired a salesforce of 53 representatives covering Japan. Other preparations include a new supply agreement that will hopefully alleviate the quality control issues experienced in 2020.

Convert existing patients to liquid formulations

The company’s strategy for maximizing the value of Treakisym has been focused on the pipeline management of the product to give it a sales runway following the rights transfer and expiration of exclusivity in 2020. Key to this is converting existing patients onto the recently launched RTD formulation and the rapid infusion (RI) formulation expected to be approved in 2022, both of which carry exclusivity protections until 2031. This is a strategy that worked in the US where the majority of the market converted to the liquid formulations developed by the RTD formulation’s licensor Eagle Pharmaceuticals.

Launch the DLBCL indication

Additionally, the company plans to expand the Treakisym market by seeking approval for the second-line treatment of DLBCL. We estimate the market for this condition in Japan at approximately 11,200 relapsed and refractory patients per year. This would be the first jurisdiction to our knowledge that would approve bendamustine for this indication, although it is well supported by the science. The company submitted a marketing application to the PMDA in May 2020 and we expect a response around the one year anniversary.

Valuation: Increased to ¥39.7bn

We have increased our valuation to ¥39.7bn from ¥37.8bn, although it is lower on a per share basis, (¥1,040 from ¥1,074) due to higher shares outstanding. This results from rolling forward our NPVs and is offset by lower net cash (¥3.85bn from ¥5.41bn).

The relaunch is only the beginning

A very large part of the company’s operations over the preceding years has been in preparation for now, in 2021 when the company regains marketing rights to its lead asset Treakisym from Eisai. Eisai has been marketing the product in Japan since its launch in 2010, and returned the product rights to SymBio in December 2020. In 2020, SymBio established the necessary infrastructure and began building out its salesforce. It reported in February 2021 that it had hired a sales staff of 62, of whom 53 are medical representatives. Additionally the company has secured distributors and a new manufacturer for the product. There were significant supply disruptions in 2020 and earlier due to issues with the product from its earlier supplier Astellas, and we expect those problems to now be resolved.

The product also lost marketing exclusivity in 2020, so SymBio has developed a strategy for protecting its market share in the product by converting existing patients to new formulations of the product. This is a strategy that worked in the US, where a majority of patients have been converted to liquid formulations (RTD and a rapid infusion, RI, formulation) of the drug developed by Eagle Pharmaceuticals and licensed by Teva. The RTD formulation was approved by the PMDA in 2020 and launched by SymBio in January 2021. The RI formulation has been in pivotal clinical studies (last patient enrolled in September 2020), and the company announced that it expects it to be launched in 2022. The company has guided that it hopes to convert the majority of patients onto the RTD formulation in 2021, and we hope the company will provide details on this progress.

In addition to the new formulations, the company is also awaiting the approval of the product for DLBCL, which we expect by May 2021. The product is not approved for this indication in other geographies that we are aware of, but has established efficacy in the indication, and the company demonstrated this in pivotal studies.

In other news, the company has initiated a collaboration with the University of Tokyo to explore potential applications for rigosertib in combination with bendamustine. Rigosertib is an RAS inhibitor developed by Onconova Therapeutics, to which Symbio has licensed the Japanese rights. The product failed to meet its primary endpoint in a Phase III clinical study in patients with high-risk myelodysplastic syndrome, but the intention is that the collaboration with the University of Tokyo can identify a useful application for the drug. The focus of the research will continue to be in hematopoietic indications. We do not currently assign any value to rigosertib, but believe at the very least it is worthy of further study. The product is also in a Phase I investigator-sponsored study of non-small cell lung cancer (NSCLC).

Financials and guidance

SymBio announced revenue of ¥2.98bn in 2020, which came in higher than our expectations (¥2.61bn). We expected a more severe impact on sales from COVID-19 and the supply disruption in the second half of the year. SG&A expenses also came in under our estimates (¥3.11bn vs ¥3.32bn), despite the company successfully building out its salesforce. We have revised our 2021 forecasts to take into account this more efficient cost base, but otherwise our forecasts remain largely unchanged. We expect a substantial increase in SG&A expenses with the new marketing costs for Treakisym: ¥5.65bn in 2021 from ¥3.11bn in 2020 (reported as non-R&D operating costs). The other changes to our model are limited to minor adjustments to future run rates based on the 2020 financials.

The company released guidance and forecasts for 2021 and onward, which are close to our own estimates. It expects to be profitable for the first time in 2021, with a revenue forecast of ¥9.15bn (vs our estimate of ¥9.23bn) and ordinary profit of ¥1.36bn (our estimate ¥1.41bn). In addition, the company’s mid-range plan also outlined a series of aggressive goals for 2021 that go beyond guidance, including a target revenue objective of ¥11.3bn. The company estimates that to reach this goal the company would need to have ¥8.7bn in sales in existing markets, which is close to our current assumptions, as well as ¥2.6bn in sales for DLBCL, which we believe would be a challenge. We currently forecast about ¥500m in DLBCL sales in 2021, because we expect some headwinds with a new marketing team targeting a new indication for the product.

The company ended 2021 with ¥3.85bn in cash. We do not expect the company to need additional capital to finance its operations, but it may raise capital to continue to expand its product development pipeline. In December, the company concluded its rights offering after raising ¥4.24bn during the year.

Valuation

We have increased our valuation to ¥39.7bn from ¥37.8bn, although it is lower on a per share basis, ¥1,040 per share from ¥1,074 per share, due to increased shares outstanding. The increase in valuation is driven by rolling forward our NPVs, and is offset by lower cash (¥3.85bn at year-end 2020 from ¥5.41bn in H120) and the small change to SG&A costs outlined above. Otherwise our estimates remain unchanged.

Exhibit 1: Valuation of SymBio

Program

Indication

Probability of success

Launch year

Peak revenue (¥m)

Valuation (¥m)

Treakisym

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

100–95%

2010

8,600

20,990.54

Treakisym (DLCBL)

r/r DLBCL

90%

2021

9,600

13,664.69

Brincidofovir

AdV following HSCT

20%

2025

9,100

1,242.42

Total

35,897.65

Net cash and equivalents (December 2020)

3,848.63

Total firm value (¥m)

39,746.28

Total basic shares (m)

38.20

Value per basic share (¥)

1,040.40

Source: SymBio reports, Edison Investment Research

Exhibit 2: Financial summary

¥m

2019

2020

2021e

2022e

JPN GAAP, year-end 31 December

JPN GAAP

JPN GAAP

JPN GAAP

JPN GAAP

INCOME STATEMENT

Revenue

 

 

2,837.8

2,987.1

9,227.8

11,483.8

Cost of Sales

(1,973.0)

(2,120.2)

(1,618.7)

(2,261.2)

Gross Profit

864.8

866.9

7,609.1

9,222.6

R&D

(2,441.6)

(2,266.6)

(465.0)

(820.0)

SG&A

(2,724.8)

(3,106.5)

(5,647.7)

(6,398.5)

EBITDA

(4,263.5)

(4,441.4)

1,561.2

2,069.6

Depreciation & amortisation

(38.1)

(64.8)

(64.8)

(65.4)

Normalised operating profit

 

 

(4,174.5)

(4,403.8)

1,598.8

2,106.5

Reported operating profit

 

 

(4,301.6)

(4,506.2)

1,496.4

2,004.1

Net interest

(75.0)

(109.7)

(90.3)

(89.1)

Joint ventures & associates (post tax)

0.0

0.0

0.0

0.0

Exceptionals

4.2

529.5

0.0

0.0

Profit Before Tax (norm)

 

 

(4,249.5)

(4,513.5)

1,508.4

2,017.5

Profit Before Tax (reported)

 

 

(4,372.5)

(4,086.4)

1,406.1

1,915.1

Reported tax

(3.8)

(3.8)

(476.4)

(577.3)

Profit After Tax (norm)

(4,253.3)

(4,517.3)

1,032.1

1,440.1

Profit After Tax (reported)

(4,376.3)

(4,090.2)

929.7

1,337.7

Minority interests

0.0

0.0

0.0

0.0

Discontinued operations

0.0

0.0

0.0

0.0

Net income (normalised)

 

 

(4,253.3)

(4,517.3)

1,032.1

1,440.1

Net income (reported)

 

 

(4,376.3)

(4,090.2)

929.7

1,337.7

Basic average number of shares outstanding (m)

23.2

33.0

38.2

39.6

EPS - basic normalised (¥)

 

 

(183.72)

(137.10)

27.02

37.29

EPS - diluted normalised (¥)

 

 

(180.46)

(135.38)

26.72

36.89

EPS - basic reported (¥)

 

 

(189.03)

(124.13)

24.34

34.64

Dividend (¥)

0.00

0.00

0.00

0.00

BALANCE SHEET

Fixed Assets

 

 

386.5

459.4

429.3

421.6

Intangible Assets

240.5

301.8

251.0

217.1

Tangible Assets

75.5

76.7

97.4

123.7

Investments & other

70.4

80.9

80.9

80.9

Current Assets

 

 

4,887.5

5,815.3

6,600.7

8,048.2

Stocks

0.0

944.4

181.8

254.0

Debtors

549.3

407.0

1,011.3

1,258.5

Cash & cash equivalents

3,910.8

3,848.6

4,792.4

5,920.4

Other

427.4

615.2

615.2

615.2

Current Liabilities

 

 

(872.2)

(1,615.3)

(1,440.8)

(1,543.0)

Creditors

(33.2)

(583.5)

(483.3)

(574.1)

Tax and social security

(87.8)

(81.9)

0.0

0.0

Short term borrowings

0.0

0.0

0.0

0.0

Other

(751.3)

(949.9)

(957.5)

(968.9)

Long Term Liabilities

 

 

(1.6)

(2.1)

(2.1)

(2.1)

Long term borrowings

0.0

0.0

0.0

0.0

Other long term liabilities

(1.6)

(2.1)

(2.1)

(2.1)

Net Assets

 

 

4,400.1

4,657.3

5,587.0

6,924.8

Minority interests

0.0

0.0

0.0

0.0

Shareholders' equity

 

 

4,400.1

4,657.3

5,587.0

6,924.8

CASH FLOW

Op Cash Flow before WC and tax

(4,334.4)

(4,021.6)

1,470.9

1,980.5

Working capital

(242.1)

(229.0)

(23.8)

(228.6)

Exceptional & other

229.5

130.0

102.4

102.4

Tax

(3.8)

(3.8)

(476.4)

(577.3)

Net operating cash flow

 

 

(4,350.7)

(4,124.4)

1,073.1

1,276.9

Capex

(216.5)

(160.3)

(129.4)

(148.8)

Acquisitions/disposals

0.0

0.0

0.0

0.0

Equity financing

3,740.0

4,222.1

0.0

0.0

Dividends

0.0

0.0

0.0

0.0

Other

0.0

0.0

0.0

0.0

Net Cash Flow

(827.2)

(62.6)

943.7

1,128.1

Opening net debt/(cash)

 

 

(4,821.4)

(3,910.8)

(3,846.7)

(4,790.5)

FX

(83.4)

(1.5)

0.0

0.0

Other non-cash movements

0.0

1.9

0.0

0.0

Closing net debt/(cash)

 

 

(3,910.8)

(3,848.6)

(4,790.5)

(5,918.5)

Source: SymBio 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 2021 Edison Investment Research Limited (Edison).

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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.

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.

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United Kingdom

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1185 Avenue of the Americas

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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 2021 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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Brighter — Progress in multiple regions

Brighter has been making progress in multiple regions for Actiste, which now has market approval in Saudi Arabia, the United Arab Emirates (UAE) and Thailand, as well as a five-year distribution agreement in Qatar and five-year agreements in both Nigeria and Ghana. Once registrations are in place in Nigeria and Ghana, Brighter expects to receive €2.3m (SEK23.4m) and €1.2m (SEK12.2m), respectively, in initial orders in those countries. The approval processes in Nigeria and Ghana are expected to begin in March 2021 and complete by the end of the year.

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