SymBio Pharmaceuticals — The first whole quarter of internal SymBio sales

SymBio Pharmaceuticals (TYO: 4582)

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Research: Healthcare

SymBio Pharmaceuticals — The first whole quarter of internal SymBio sales

SymBio reported Q121 sales of ¥1.42bn of its drug Treakisym (bendamustine) for hematologic malignancies. This is the first quarter in which the product is being sold by SymBio directly, and it marks a substantial increase over prior sales trends. Sales have more than doubled since Q420 (¥0.6bn). Part of what is driving this is the early 2021 launch of the company’s ready-to-dilute (RTD) formulation. Moreover, SymBio recently expanded the indications approved for the drug to include diffuse large B-cell lymphoma (DLBCL), which may also drive future sales.

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Healthcare

SymBio Pharmaceuticals

The first whole quarter of internal SymBio sales

Earnings update

Pharma & biotech

27 May 2021

Price

¥1,740

Market cap

¥66,645m

¥110/US$

Net cash (¥bn) at 31 March 2021

2.93

Shares in issue

38.3m

Free float

91%

Code

4582

Primary exchange

TYO

Secondary exchange

OTC US

Share price performance

%

1m

3m

12m

Abs

41.0

13.9

249.6

Rel (local)

40.7

14.3

173.6

52-week high/low

¥1,740

¥337

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

RI approval decision

2021

Analyst

Nathaniel Calloway

+1 646 653 7036

SymBio Pharmaceuticals is a research client of Edison Investment Research Limited

SymBio reported Q121 sales of ¥1.42bn of its drug Treakisym (bendamustine) for hematologic malignancies. This is the first quarter in which the product is being sold by SymBio directly, and it marks a substantial increase over prior sales trends. Sales have more than doubled since Q420 (¥0.6bn). Part of what is driving this is the early 2021 launch of the company’s ready-to-dilute (RTD) formulation. Moreover, SymBio recently expanded the indications approved for the drug to include diffuse large B-cell lymphoma (DLBCL), which may also drive future sales.

Year end

Revenue (¥bn)

PBT*
(¥bn)

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

64.4

N/A

12/22e

11,484

2,018

37

0

47.0

N/A

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

SymBio markets Treakisym for the first time

SymBio is simultaneously executing on multiple parts of its strategy to control the lifecycle of Treakisym and expand its sales in Japan. In late 2020, the rights to market the drug in Japan were returned to the company from Eisai, so SymBio now directly markets the product in Japan. The strong growth in the product is in spite of residual Eisai inventory on the market, as well as the negative impacts of COVID19. The return of rights to the product has also substantially improved SymBio’s margins on the product: 71% gross margins from 23% in Q120. The company’s other expenses have only increased slightly (¥1.22bn in other operational costs from ¥1.09bn in Q120).

DLBCL expanded to RTD formulation

SymBio is expanding the market for Treakisym both by launching new formulations of the drug such as RTD (approved in September 2020) and rapid infusion (RI, approval expected in 2022), and by seeking approval for new indications, in particular for DLBCL. As part of this the company will be submitting partial change applications to the PMDA (similar to sNDA applications to the FDA) to expand the target indications for the new formulations as well. For instance, in April 2021 SymBio received approval to market the RTD formulation for DLBCL.

Valuation: ¥43.4bn or ¥1,133 per basic share

Our valuation of SymBio is approximately flat: ¥43.4bn or ¥1,133 per basic share, from ¥43.2bn or ¥1,131 per share previously. We have rolled forward our NPVs and this was offset by a lower new net cash (¥2.93bn from ¥3.85bn). We expect the company to reach profitability in 2021.

Commercial update

The most recent quarter reported by SymBio, Q121, is the first in which it has truly operated as an independent commercial entity. In early December 2020 the company formally commenced sales of Treakisym using its own internal salesforce and the current period marks the first with its sales wholly under SymBio’s control. This is part of the company’s longstanding strategy to manage the asset following the return of marketing rights to it from Eisai at the end of 2020. SymBio reported sales of ¥1.42bn, which we consider very encouraging. We currently forecast sales of ¥9.23bn for 2021, which is largely based on the company recapturing the prior Eisai market, and a smaller increase (~¥500m) as it enters the DLBCL market (more below). Part of the strategy to retain this market is through the offering of additional formulations of the drug. SymBio has already received approval for the RTD formulation, which it launched in January 2021, and this may have helped sales. The company submitted an application for the RI formulation in May 2021 and expects to be able to market the product in 2022. SymBio has stated that it intends to convert 91% of existing prescribers to the liquid formulation by the end of 2021.

Internally marketing the product has substantially improved the company’s margins from previous reports: 71% gross margins from 23% in Q120. Other operational expenses were ¥1.22bn compared to ¥1.09bn in Q120, which we think is a very small increase associated with the launch of a drug for the first time. We expect the cost of selling to increase throughout 2021 as the company puts increasing effort into marketing the RTD formulation and markets the drug for DLBCL. We forecast ¥6.11bn in operational costs in 2021, which remains unchanged from our previous estimates. The operational loss for Q121 was ¥0.21bn. Based on this, we believe that SymBio may reach profitability in 2021, so we do not expect it to need additional capital for normal operations.

Development update

SymBio previously announced the approval of Treakisym for the treatment of DLBCL in March 2021. In April 2021, it announced that the RTD formulation of the drug was also approved for this indication. Although we are not surprised by this decision, we are encouraged that the company is executing on its two-pronged strategy to convert patients onto its proprietary formulations of the drug as well as to expand the market to include additional indications like DLBCL. The application for the RTD formulation was a ‘partial change’ application, which is similar to a supplemental new drug application (sNDA) used in the US with the FDA, and is much expedited compared to initial approvals. We expect SymBio to also seek approval of the RI formulation for DLBCL in the future. The company submitted an application for the RI formulation in May 2021.

DLBCL is an intermediate or high-risk form of Non-Hodgkin’s lymphoma (NHL), but accounts for the largest fraction of NHL cases in Japan and elsewhere. Approximately 45% of NHL cases in Japan are DLBCL, corresponding to approximately 16,000 patients.1 Assuming that 70% of DLBCL patients progress to receive second-line therapy, we forecast a target market of 11,200 second-line (r/r) DLBCL patients per year, which would approximately double the addressable market for the drug. This combination has been previously studied in a number of different trials across the globe, and is among the arsenal of treatment regimens available to doctors despite not being formally approved elsewhere.

  Chihara D, et al. (2013) Differences in incidence and trends of haematological malignancies in Japan and the United States. Brit J Haem 164, 536-545.

Valuation

We have increased our valuation to ¥43.4bn or ¥1,133 per basic share, from ¥43.2bn or ¥1,131 per share previously. This minor increase is driven by rolling forward our NPVs, and offset by lower net cash (¥2.93bn from ¥3.85bn). Otherwise our models 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

21,596.57

Treakisym (DLCBL)

r/r DLBCL

100–95%

2021

9,600

17,543.02

Brincidofovir

AdV following HSCT

20%

2025

9,100

1,278.62

Total

40,418.21

Net cash and equivalents (March 2021)

2,933.67

Total firm value (¥m)

43,351.87

Total basic shares (m)

38.26

Value per basic share (¥)

1,133.14

Source: SymBio Pharmaceuticals reports, Edison Investment Research

Exhibit 2: Financial summary

¥m

2019

2020

2021e

2022e

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

38.6

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)

(1,423.3)

(1,525.4)

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)

(940.0)

(951.3)

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

5,604.6

6,942.3

Minority interests

0.0

0.0

0.0

0.0

Shareholders' equity

 

 

4,400.1

4,657.3

5,604.6

6,942.3

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)

(3,848.6)

(4,792.4)

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)

(4,792.4)

(5,920.4)

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 2021 Edison Investment Research Limited (Edison).

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New Zealand

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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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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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