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International Stem Cell — Third cohort ready to go

International Stem Cell — Third cohort ready to go

International Stem Cell (ISCO) recently announced that the data safety monitoring board for its Phase I trial of ISC-hpNSC in Parkinson’s disease (PD) has authorized the enrollment of the third cohort of four patients. The study has already enrolled eight patients at the 30m and 50m cell levels and will now enroll patients at the 70m cell level. Recruitment will begin immediately. The company announced interim six-month results from the first cohort of four patients in November and we expect additional data from this as well as the second cohort in the coming months.

Analyst avatar placeholder

Written by

International Stem Cell

Third cohort ready to go

Financial update

Pharma & biotech

6 June 2018

Price

US$1.68

Market cap

US$10m

Net cash ($m) at 31 March 2018

0.10

Shares in issue

6.20m

Free float

26.4%

Code

ISCO

Primary exchange

OTC

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

16.7

8.4

40.0

Rel (local)

13.0

7.3

24.1

52-week high/low

US$1.9

US$1.1

Business description

International Stem Cell is an early-stage biotechnology company developing therapeutic, biomedical and cosmeceutical applications for its proprietary stem form of pluripotent stem cells – human parthenogenetic stem cells. Its lead candidate is a cell therapy treatment for Parkinson’s disease.

Next events

Publication of interim results in scientific journal

2018

Initiation of Phase II in traumatic brain injury and PD

2018

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

International Stem Cell is a research client of Edison Investment Research Limited

International Stem Cell (ISCO) recently announced that the data safety monitoring board for its Phase I trial of ISC-hpNSC in Parkinson’s disease (PD) has authorized the enrollment of the third cohort of four patients. The study has already enrolled eight patients at the 30m and 50m cell levels and will now enroll patients at the 70m cell level. Recruitment will begin immediately. The company announced interim six-month results from the first cohort of four patients in November and we expect additional data from this as well as the second cohort in the coming months.

Year
end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/16

7.2

(4.9)

(0.34)

0.0

N/A

N/A

12/17

7.5

(4.9)

(1.46)

0.0

N/A

N/A

12/18e

8.8

(6.7)

(0.98)

0.0

N/A

N/A

12/19e

9.5

(8.5)

(1.27)

0.0

N/A

N/A

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

Trial in PD continues

Patients in the study are being treated in three cohorts with 30m, 50m and 70m stem cells, delivered via intracranial injection. The single-arm, open-label study is being conducted at the Royal Melbourne Hospital in Australia. Clinical assessments are scheduled at six and 12 months following surgery. The company expects to start a Phase II PD trial later in 2018.

Traumatic brain injury Phase II coming later in 2018

The company has completed preclinical studies of ISC-hpNSC in traumatic brain injury (TBI) and is preparing for a Phase II trial that should begin in 2018. According to the Centers for Disease Control, TBI accounts for 2.5m emergency room visits in the US annually and approximately 3.2–5.3 million people are living with a TBI-related disability.

Biomedical business growing well

ISCO’s commercial operations leverage its hpSC technology and generate revenues to partially offset R&D spending for therapeutic development. Lifeline Skin Care develops and sells skincare products and Lifeline Cell Technology (LCT) produces human cell culture products for testing. Together they generated $7.5m in sales and $1.4m in operating profit in 2017. In Q118, LCT alone generated $2.1m in revenues, providing $837,000 in operating profit.

Valuation: $34m or $5.46 per basic share

Our valuation remains $34m, although on a per-share basis it has increased to $5.46 from $5.45. Increases to our revenue estimates for the base business were mostly cancelled out by an increase in long-term SG&A expense expectations. Additionally, net cash is slightly lower and there are slightly more shares outstanding. We project that the company will need at least $62.5m in additional financing before profitability in 2024, of which a total additional $7.5m will be required by the end of 2018.

Q1 results

ISCO reported Q118 revenues of $2.6m, up 28.1% compared to Q117 mainly due to the biomedical business, which had quarterly revenues of $2.1m, up 51.6% compared to the same quarter last year. The cosmetics business, however, was down 16.6% in the quarter. The operating profit of the biomedical business increased substantially, up 68.4% to $837,000, although the cosmetic business showed a loss for the quarter. The commercial businesses combined had a profit of $631,000, up 10.3% compared to Q117. For the company as a whole, the operating loss was $1.2m for Q118, a 13.2% increase compared to the same quarter last year due to increased spending on the pipeline. We have made some adjustments to our model, increasing our 2018 revenue estimate for the commercial business to $8.8m from $8.2m and our 2019 estimate to $9.5m from $8.8m due to significant strength in the biomedical segment. We have also reduced our 2018 R&D estimate by $1.5m as the spending rate is lower than we had anticipated but left future years the same. We also increased our SG&A expense estimate by $0.9m in 2018 and by $0.2m in 2019 due to a higher than anticipated run rate.

Exhibit 1: Changes to estimates

$000s

Revenue

Operating profit

Profit after tax

Old

New

% change

Old

New

% change

Old

New

% change

2018e

8,193

8,790

7.3%

(6,659)

(6,073)

8.8%

(7,259)

(6,673)

17.0%

2019e

8,846

9,527

7.7%

(6,942)

(7,079)

(2.0%)

(8,342)

(8,479)

(1.6%)

Source: Edison Investment Research. Note: Operating profit and profit after tax exclude amortization of acquired intangibles, exceptional items and share-based payments.

The company had $447,000 in cash on the balance sheet at 31 March 2018. There is $351,000 in a related-party payable stemming from a promissory note that provided cash to the company from its co-chairman and CEO, with the note due and payable on 1 November this year. Subsequent to the quarter, the co-chairman and CEO provided an additional $150,000 and agreed to provide an additional $300,000 in increments based on the company’s needs. We continue to project that the company will need at least $62.5m in additional financing before profitability (which we include as illustrative long-term debt) in 2024, of which a total additional $7.5m will be required by the end of 2018 and a further $10m by the end of 2019.

Cartilage generation paper published

The company also announced that a paper it prepared, Supplementation of Specific Carbohydrates Results in Enhanced Deposition of Chondrogenic-Specific Matrix during Mesenchymal Stem Cell Differentiation was published and featured on the cover of the May 2018 issue of the Journal of Tissue Engineering and Regenerative Medicine. The article discusses a scalable system that permits the generation of functional human cartilage tissue from human mesenchymal stem cells. As a result, the company subsequently announced plans to launch an advanced joint supplement, designed to potentially reduce joint pain associated with osteoarthritis, in Q318. Initially, it will be a soft launch geared towards existing Lifeline Skin Care customers, with a broader launch potentially coming afterwards.

Valuation

Our valuation remains $34m, although on a per-share basis it has increased to $5.46 from $5.45. Increases to our revenue estimates for the base business were mostly cancelled out by an increase in long-term SG&A expense expectations. Additionally, net cash is slightly lower and there are slightly more shares outstanding.

Exhibit 2: International Stem Cell valuation

Product

Status

Launch

Peak sales ($m)

NPV ($m)

Probability of success

rNPV ($m)

NPV/ share ($/share)

Cosmetic and biomedical business

Commercial

Current

18

24

90%

21

3.44

PD (royalties at 12% of sales)

Phase I/IIa

2024

2,800

528

7.5%

40

6.39

G&A expense – after tax

100%

(27)

(4.39)

Net cash

0.1

100%

0.1

0.02

Valuation

 

 

 

552

 

34

5.46

Source: Edison Investment Research

Exhibit 3: Financial summary

US$000s

2015

2016

2017

2018e

2019e

Year-end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

7,551

7,165

7,456

8,790

9,527

Cost of Sales

(2,056)

(1,944)

(2,122)

(2,725)

(2,953)

Gross Profit

5,495

5,221

5,334

6,065

6,574

Research and development

(2,707)

(2,856)

(2,658)

(4,500)

(6,500)

EBITDA

 

 

(4,092)

(4,520)

(4,616)

(5,801)

(6,807)

Operating Profit (before amort. and except.)

(4,564)

(4,851)

(4,942)

(6,073)

(7,079)

Intangible Amortisation

0

0

0

0

0

Exceptionals

0

0

0

0

0

Other

1,929

3,772

(1,127)

355

0

Operating Profit

(2,635)

(1,079)

(6,069)

(5,718)

(7,079)

Net Interest

0

0

0

(600)

(1,400)

Profit Before Tax (norm)

 

 

(4,564)

(4,851)

(4,942)

(6,673)

(8,479)

Profit Before Tax (reported)

 

 

(2,635)

(1,079)

(6,069)

(6,318)

(8,479)

Tax

0

0

0

0

0

Profit After Tax (norm)

(2,635)

(1,079)

(6,069)

(6,318)

(8,479)

Profit After Tax (reported)

(2,635)

(1,079)

(6,069)

(6,318)

(8,479)

Average Number of Shares Outstanding (m)

2.0

3.2

4.2

6.4

6.7

EPS - normalised ($)

 

 

(1.29)

(0.34)

(1.46)

(0.98)

(1.27)

EPS - normalised fully diluted ($)

 

 

(1.29)

(0.34)

(1.46)

(0.98)

(1.27)

EPS - (reported) (US$)

 

 

(1.29)

(0.34)

(1.46)

(0.98)

(1.27)

Dividend per share (c)

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

72.8

72.9

71.5

69.0

69.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

4,147

4,553

4,009

4,693

5,363

Intangible Assets

3,223

3,484

2,922

3,538

4,154

Tangible Assets

864

1,011

1,013

1,080

1,134

Investments

60

58

74

75

75

Current Assets

 

 

2,991

2,492

2,855

5,407

7,407

Stocks

1,348

1,390

1,307

1,385

1,701

Debtors

539

574

465

939

680

Cash

532

110

304

2,444

4,387

Other

572

418

779

639

639

Current Liabilities

 

 

(5,544)

(3,601)

(4,800)

(5,478)

(5,244)

Creditors

(5,544)

(3,601)

(4,800)

(5,478)

(5,244)

Short term borrowings

0

0

0

0

0

Long Term Liabilities

 

 

0

0

0

(7,500)

(17,500)

Long term borrowings

0

0

0

(7,500)

(17,500)

Other long term liabilities

0

0

0

0

0

Net Assets

 

 

1,594

3,444

2,064

(2,878)

(9,973)

CASH FLOW

Operating Cash Flow

 

 

(4,120)

(4,197)

(2,142)

(3,832)

(5,714)

Net Interest

0

0

0

(600)

(1,400)

Tax

0

0

0

0

0

Capex

(738)

(944)

(864)

(928)

(943)

Acquisitions/disposals

0

0

0

0

0

Financing

1,169

4,018

3,200

0

0

Dividends

0

0

0

0

0

Net Cash Flow

(3,689)

(1,123)

194

(5,360)

(8,057)

Opening net debt/(cash)

 

 

(1,111)

(532)

(110)

(304)

5,056

HP finance leases initiated

0

0

0

0

0

Other

3,110

701

0

0

0

Closing net debt/(cash)

 

 

(532)

(110)

(304)

5,056

13,113

Source: Edison Investment Research, company accounts

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Pty Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by International Stem Cell and prepared and issued by Edison for publication globally. 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. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US 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. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and 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 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. This document is provided 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. Edison has a restrictive policy relating to personal dealing. 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. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. 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. 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 (ie 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. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2018. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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

295 Madison Avenue, 18th Floor

10017, New York

US

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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Pty Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by International Stem Cell and prepared and issued by Edison for publication globally. 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. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US 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. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and 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 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. This document is provided 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. Edison has a restrictive policy relating to personal dealing. 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. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. 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. 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 (ie 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. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2018. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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

295 Madison Avenue, 18th Floor

10017, New York

US

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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Research: Healthcare

Clal Biotechnology Industries — Portfolio progress continues

Clal Biotechnology Industries’ (CBI) portfolio of investments continues to demonstrate forward-looking business development and clinical progress. Notably, MediWound announced in May that it is now in discussions with multiple third parties interested in a strategic transaction. Still, the nature of these approaches remains unclear. Also, BioCanCell announced a $23m private equity investment and plans to use the proceeds to initiate two studies for its lead programme. Lastly, Neon filed a prospectus with the SEC detailing an IPO expected to raise ~$100m on NASDAQ.

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