CASI Pharmaceuticals — Continuing to execute

CASI Pharmaceuticals (US: CASI)

Last close As at 28/03/2024

1.23

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Market capitalisation

172m

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Research: Healthcare

CASI Pharmaceuticals — Continuing to execute

CASI continues to execute on multiple fronts and demonstrates that it has become a multifaceted company. It is expanding the sales of Evomela, its proprietary formulation of melphalan for multiple myeloma in China. Simultaneously, it is adding to its pipeline with new licensing deals and is executing on its development strategy, with four drug candidates currently in the clinic.

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Written by

Healthcare

CASI Pharmaceuticals

Continuing to execute

Earnings update

Pharma & biotech

18 May 2021

Price

US$1.5

Market cap

US$203m

Net cash ($m) at 31 March 2021

77.13

Shares in issue

139.8m

Free float

72%

Code

CASI

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(22.9)

(49.8)

(16.7)

Rel (local)

(21.6)

(51.4)

(41.1)

52-week high/low

US$3.6

US$1.4

Business description

CASI Pharmaceuticals is building a portfolio of drugs it intends to market for Chinese and worldwide markets, including Evomela launched in China, anti-CD19 CAR-T therapy CNCT19 and anti-CD38 drug CID-103, among others. The goal is to seek approval through new pathways that have opened in the quickly changing Chinese regulatory environment.

Next events

Phase I CAR-T studies complete

Imminent

Analyst

Nathaniel Calloway

+1 646 653 7036

CASI Pharmaceuticals is a research client of Edison Investment Research Limited

CASI continues to execute on multiple fronts and demonstrates that it has become a multifaceted company. It is expanding the sales of Evomela, its proprietary formulation of melphalan for multiple myeloma in China. Simultaneously, it is adding to its pipeline with new licensing deals and is executing on its development strategy, with four drug candidates currently in the clinic.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/19

4.1

(36.5)

(0.39)

0.00

N/A

N/A

12/20

15.1

(37.9)

(0.35)

0.00

N/A

N/A

12/21e

25.8

(23.2)

(0.17)

0.00

N/A

N/A

12/22e

28.8

(23.8)

(0.17)

0.00

N/A

N/A

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

Evomela growth strong again

Evomela growth continues unabated as the company has reported $5.7m in sales for Q121. This is up from $3.4m in Q120 and $4.8m in Q420. CASI’s margins have improved substantially given its new supplier as costs of revenue have reduced to $2.4m in Q121 from $3.2m in Q120. The company continues to guide towards 50% growth in product sales (~$22.5m) for 2021, which we expect it to exceed.

Sourcing new treatments for hematologic disease

CASI continues to execute on its strategy of in-licensing new assets. It recently acquired the rights to CB-5339 in mainland China (as well as Taiwan, Hong Kong and Macau) from Cleave Therapeutics, a private pharma company based in San Francisco, for $5.5m upfront, $74m in milestones and mid-single to mid-double-digit royalties. The drug is an inhibitor of valosin-containing protein (VCP)/p97 and is being tested in a Phase I dosing study in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients.

Pipeline continues to progress

The company currently has four assets being tested in clinical studies, including CB-5339. The majority of these assets, like CB-5339, are being developed primarily by partners at this time. These include the other recent acquisition BI-1206 from BioInvent, in Phase I for non-Hodgkin lymphoma (NHL), and CNCT19, the CAR-T therapy in pivotal trials run by partner Juventas. But CASI has also started Phase I studies in March 2021 on its proprietary drug for multiple myeloma CID-103, which will enroll its first patient in May 2021.

Valuation: $498m or $3.56 per share

Our valuation is largely flat: down slightly on the whole to $498m from $500m, but up on a per share basis, at $3.56 from $3.54. Rolling forward our net present values (NPVs) was offset by lower net cash ($77.1m from $90.8m). We include $20m as an additional financing requirement in 2022 for the company prior to profitability in 2024.

A multifaceted strategy

What sets CASI apart from many other small to medium sized drug developers is that it is advancing a large number of independent programs at the same time. These include commercial operations, such as the growing sales of Evomela in China, as well as the company’s development activities with four ongoing clinical studies. Finally, the company also continues to expand its pipeline with the identification of new assets to license.

A major operational focus of the company is the continued expansion of its sales footprint in China. CASI currently markets Evomela in China. The drug is a proprietary formulation of melphalan developed by Spectrum Pharmaceuticals that is used as a conditioning treatment for patients undergoing hematopoietic stem cell transplantation (HSCT), predominantly for multiple myeloma. It is the only melphalan product currently approved in China. CASI reported with its Q121 results that the drug had $5.7m in sales during the period, which shows a strong growth trend. This is up from $3.2m in Q120 and $4.8m in Q420. The company reiterated its guidance that it expects 50% growth in Evomela sales in 2021 (~$22.5m from $15.0m in 2020), which we think should be achievable even if further growth slows. We currently forecast $25.6m in 2021 sales. The company’s margins are also substantially improved over prior periods: costs of revenue were $2.4m in Q121 from $3.2m in Q120. This is predominantly because CASI was using a short-term supplier previously, but has transitioned to a dedicated manufacturer.

During Q121, CASI in-licensed the Chinese rights to investigational drug CB-5339 from Cleave Therapeutics. CB-5339 is an anti-cancer drug with potential applicability to both solid tumors and hematologic neoplasms. It is an inhibitor of VCP/p97, a protein involved in the maintenance and degradation of other proteins in the cell. Its inhibition can induce DNA damage, to which cancer cells are sensitive. The protein’s primary function is to isolate certain proteins and traffic them to degradation in the proteasome. We therefore expect the profile of the drug (if it is active) to resemble that of proteasome inhibitors such as Velcade (bortezomib, Takeda). Drugs of the proteasome inhibitor class are used in the treatment of multiple myeloma and indolent N, such as mantle cell lymphoma. These drugs as a class have significant adverse effect profiles that include cytopenias, gastrointestinal upset and peripheral neuropathy, among others. A drug such as CB-5339 may be a viable alternative to proteasome inhibitors if it can improve on this adverse effect profile.

CB-5339 marks the fourth product the company has licensed that is currently in the clinic. These include the other recent acquisition BI-1206 from BioInvent, in Phase I for NHL, and CNCT19, a CAR-T therapy run by partner Juventas. CNCT19 is the most advanced-stage development asset and is in pivotal studies. Additionally, the company has stated that it intends to release data from the earlier Phase I studies of CNCT19 in 2021, as these studies were slated to complete in Q121. The company also initiated a Phase I study of its wholly owned asset CID-103 in March 2021, and it expects to enroll the first patient in May 2021. R&D spending for Q121 was reported as $5.3m, up from $3.0m in Q120. We expect these expenses to continue at approximately this level through 2021 (estimated 2021 R&D $20.4m). This would be up from $11.5m in 2020.

CASI ended the period with $77.1m in net cash. This follows the company’s earlier 24 March offering of $32.5m gross (at $2.05 per share for 15.85m new shares), as well as the $11m cost of the transaction with Cleave Therapeutics (which included $5.5m upfront and a $5.5m investment in Cleave through a convertible note). We continue to include $20m as an additional financing requirement in 2022 for the company prior to profitability in 2024 (recorded as illustrative debt), although the company may want to raise additional capital for the execution of additional licensing deals.

Valuation

Our valuation is largely flat: down slightly on the whole to $498m from $500m previously, but up on a per share basis to $3.56 from $3.54. Our share count is slightly lower (140m from 141m previously) following the final share count after the offering was complete (as reported in the Q121 financials). The valuations for the company’s individual programs are up on rolling forward our NPVs, and this is offset by lower net cash ($77.1m at the end of Q121, which includes liquid investments, from $90.8m previously). Our valuation assumptions remain unchanged otherwise.

Exhibit 1: Valuation of CASI

Portfolio

Asset

Region

Peak sales ($m)

Margins

Clinical risk adjustment

Value
($m)

Hematology

Evomela

China

39.1

50%

100%

94.31

Zevalin

China

25.5

64%

90%

45.83

Thiotepa

China

8.8

39%

90%

4.86

CID-103

China, US & Europe

766.6

59%

10%

42.26

CNCT19

China

306.2

up to 50% profit share

10%

27.62

BI-1206

China

249.9

59%

10%

18.29

CB-5339

China

77.3

52%

10%

10.20

Other products

ANDA portfolio

China & US

142.0

47%

100%

186.29

Octreotide LAI

China

15.7

41%

80%

13.05

Total

442.72

Net cash and equivalents (Q121) ($m)

77.13

Noncontrolling interest ($m)

(22.16)

Total firm value ($m)

497.69

Total shares (m)

139.80

Value per basic share ($)

3.56

Dilutive warrants and options (m)

16.75

Value per diluted share ($)

3.47

Source: CASI reports, Edison Investment Research

Exhibit 2: Financial summary

$'000s

2019

2020

2021e

2022e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

INCOME STATEMENT

Revenue

 

 

4,131.0

15,141.0

25,750.0

28,791.2

Cost of Sales

(3,935.0)

(9,508.0)

(6,402.5)

(7,162.8)

Gross Profit

196.0

5,633.0

19,347.5

21,628.4

EBITDA

 

 

(37,495.0)

(41,361.0)

(23,086.1)

(22,838.4)

Normalised operating profit

 

 

(38,098.0)

(41,923.0)

(23,223.6)

(23,771.2)

Amortization of acquired intangibles

(1,550.0)

(1,397.0)

(1,397.0)

(1,397.0)

Exceptionals

0.0

(385.0)

0.0

0.0

Share-based payments

(7,310.0)

(7,821.0)

(7,821.0)

(7,821.0)

Reported operating profit

(46,958.0)

(51,526.0)

(32,441.6)

(32,989.2)

Net Interest

1,062.0

866.0

0.0

0.0

Joint ventures & associates (post tax)

0.0

0.0

0.0

0.0

Exceptionals

534.0

3,149.0

0.0

0.0

Profit Before Tax (norm)

 

 

(36,502.0)

(37,908.0)

(23,223.6)

(23,771.2)

Profit Before Tax (reported)

 

 

(45,362.0)

(47,511.0)

(32,441.6)

(32,989.2)

Reported tax

0.0

0.0

6,488.3

6,597.8

Profit After Tax (norm)

(36,502.0)

(37,908.0)

(23,223.6)

(23,771.2)

Profit After Tax (reported)

(45,362.0)

(47,511.0)

(25,953.3)

(26,391.4)

Minority interests

(670.0)

(776.0)

0.0

0.0

Discontinued operations

0.0

0.0

0.0

0.0

Net income (normalised)

(37,172.0)

(38,684.0)

(23,223.6)

(23,771.2)

Net income (reported)

(46,032.0)

(48,287.0)

(25,953.3)

(26,391.4)

Basic average number of shares outstanding (m)

96

110

137

144

EPS - basic normalised (c)

 

 

(38.74)

(35.04)

(16.96)

(16.54)

EPS - diluted normalised (c)

 

 

(38.74)

(35.04)

(16.96)

(16.54)

EPS - basic reported (c)

 

 

(47.98)

(43.73)

(18.96)

(18.36)

Dividend (c)

0.00

0.00

0.00

0.00

BALANCE SHEET

Fixed Assets

 

 

41,130.0

53,709.0

71,674.5

84,824.2

Intangible Assets

16,895.0

13,210.0

22,813.0

21,416.0

Tangible Assets

985.0

2,062.0

13,991.5

28,538.2

Investments & other

23,250.0

38,437.0

34,870.0

34,870.0

Current Assets

 

 

61,501.0

74,025.0

65,894.9

54,404.5

Stocks

4,542.0

1,356.0

2,104.9

2,354.9

Debtors

1,293.0

4,645.0

4,232.9

4,732.8

Cash & cash equivalents

54,246.0

66,373.0

57,977.1

45,736.8

Other

1,420.0

1,651.0

1,580.0

1,580.0

Current Liabilities

 

 

(7,947.0)

(7,976.0)

(8,320.9)

(8,550.5)

Creditors

(5,113.0)

(3,669.0)

(4,013.9)

(4,243.5)

Tax and social security

0.0

0.0

0.0

0.0

Short term borrowings

0.0

0.0

0.0

0.0

Other

(2,834.0)

(4,307.0)

(4,307.0)

(4,307.0)

Long Term Liabilities

 

 

(1,019.0)

(16,185.0)

(16,894.0)

(36,894.0)

Long term borrowings

0.0

0.0

(709.0)

(20,709.0)

Other long term liabilities

(1,019.0)

(16,185.0)

(16,185.0)

(16,185.0)

Net Assets

 

 

93,665.0

103,573.0

112,354.5

93,784.2

Minority interests

20,670.0

22,033.0

22,164.0

22,164.0

Shareholders' equity

 

 

72,995.0

81,540.0

90,190.5

71,620.2

CASH FLOW

Op Cash Flow before WC and tax

(37,495.0)

(41,361.0)

(23,086.1)

(22,838.4)

Working capital

4,452.0

(3,318.0)

8.1

(520.3)

Exceptional & other

9,800.0

18,793.0

6,488.3

6,597.8

Tax

0.0

0.0

0.0

0.0

Net operating cash flow

 

 

(23,243.0)

(25,886.0)

(16,589.7)

(16,760.9)

Capex

(7,053.0)

(1,499.0)

(12,067.0)

(15,479.4)

Acquisitions/disposals

(21,005.0)

(21,529.0)

(11,000.0)

0.0

Net interest

0.0

0.0

0.0

0.0

Equity financing

3,545.0

45,904.0

30,481.0

0.0

Dividends

0.0

0.0

0.0

0.0

Other

20,000.0

2,309.0

71.0

0.0

Net Cash Flow

(27,756.0)

(701.0)

(9,104.7)

(32,240.3)

Opening net debt/(cash)

 

 

(83,617.5)

(54,245.5)

(66,372.5)

(57,267.8)

FX

(1,328.0)

2,895.0

0.0

0.0

Other non-cash movements

(288.0)

9,933.0

0.0

0.0

Closing net debt/(cash)

 

 

(54,245.5)

(66,372.5)

(57,267.8)

(25,027.6)

Source: CASI reports, Edison Investment Research


General disclaimer and copyright

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

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

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

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General disclaimer and copyright

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

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

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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

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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

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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Dentsu Group — Progressive quarterly improvements

Dentsu’s Q1 update shows a third successive quarter of improvement (a reducing decline in organic revenue), with Dentsu Japan down 0.9% on Q120 and Dentsu International 3.5% below prior year. Operating margins were considerably stronger in both segments as the transformation plan has kicked in. Q221 has started very strongly, and we leave our FY21 and FY22 revenue and margin estimates unchanged, but note that if trading continues to improve, there may be scope to move numbers later in the year, subject to the status of the planned Olympics. FY22 should be a stronger year of margin growth as permanent cost reductions contribute.

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