BioLargo — Clyra gets 510(k) clearance

BioLargo (US: BLGO)

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0.27

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Research: Healthcare

BioLargo — Clyra gets 510(k) clearance

BioLargo announced on 23 September 2019 that it received 510(k) marketing clearance for the Clyra Wound Irrigation Solution developed by the Clyra Medical subsidiary. The product uses antimicrobial technology based on the delivery of iodine using chemistry similar to the other products developed by BioLargo. The product is designed for cleansing, irrigation and debridement of skin lesions (partial and full thickness) and burns (1st and 2nd degree). With this clearance, the company is free to market and distribute the product, with the ultimate goal of Clyra operating as an independent wound-care company.

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Healthcare

BioLargo

Clyra gets 510(k) clearance

Healthcare & industrial services

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26 September 2019

Price

$0.30

Market cap

$47m

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Share details

Code

BLGO

Listing

OTCQB

Shares in issue

157.4m

Net debt ($m) at 30 June 2019

3.31

Business description

BioLargo has a number of subsidiaries and products focused on using iodine chemistry. CupriDyne is a product that is currently on the market for industrial odor control. The firm is also developing the AOS as a low-cost water purification device. The Clyra Medical subsidiary is a wound care company with an iodine-based irrigation solution and SkinDisc, a cell therapy for wounds. Finally, the company has a full service environmental engineering team.

Bull

Diversified portfolio of products.

Unique technology with broad applications.

CupriDyne is gaining market share.

Bear

Additional capital needed.

Sales ramp has been slow.

Regulatory and development risk for Clyra and AOS.

Analyst

Nathaniel Calloway

+1 646 653 7036

BioLargo is a research client of Edison Investment Research Limited

BioLargo announced on 23 September 2019 that it received 510(k) marketing clearance for the Clyra Wound Irrigation Solution developed by the Clyra Medical subsidiary. The product uses antimicrobial technology based on the delivery of iodine using chemistry similar to the other products developed by BioLargo. The product is designed for cleansing, irrigation and debridement of skin lesions (partial and full thickness) and burns (1st and 2nd degree). With this clearance, the company is free to market and distribute the product, with the ultimate goal of Clyra operating as an independent wound-care company.

Bringing new technology to an established practice

Iodine has a long history in medicine and is an indispensable element of modern practice in the povidone iodine formulation (eg Betadine). However, despite its widespread use, povidone iodine is not without side effects and can cause irritation to mucous membranes and exposed tissue, and is therefore limited to topical use. The Clyra Wound Irrigation Solution instead generates small quantities of reactive iodine in situ that are too low to cause the irritation associated with other formulations (or even risk of staining), but sufficient to provide antiseptic benefit.

Product can be sold nationwide now

The 510(k) clearance means that Clyra is free to sell the product throughout the US or license it to another party for distribution. Products cleared through the 510(k) pathway must show substantial equivalence to an already approved product and not raise any additional safety or effectiveness concerns. We find it encouraging that the FDA upon examination of the data did not foresee any of these concerns with this product, but the details of the medical claims are forthcoming. We expect it to be an attractive product addressing some of the limitations of traditional iodine.

What’s next: An independent wound-care company

BioLargo has repeatedly stated its intent to spin off Clyra as an independent wound-care company, and 510(k) clearance is the first step in that process. There is little operational overlap between Clyra and the other aspects of the business, so this strategy makes sense. Moreover, the company has sought to independently finance Clyra, as the majority (59%) is owned by outside shareholders. Clyra has sought to establish a pipeline outside of the current product and in 2018 purchased the intellectual property of the SkinDisc technology, a regenerative product for wound healing. Finally, it has proposed a series of follow-on indications for the wound-care solution, including dental and orthopedic applications.

Historical financials

Year
end

Revenue
($m)

PBT
($m)

EPS
($)

DPS
($)

P/E
(x)

Yield
(%)

12/15

0.1

(5.1)

(0.06)

0.0

N/A

N/A

12/16

0.3

(8.1)

(0.09)

0.0

N/A

N/A

12/17

0.5

(9.5)

(0.10)

0.0

N/A

N/A

12/18

1.4

(10.7)

(0.09)

0.0

N/A

N/A

Source: BioLargo reports

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by BioLargo and prepared and issued by Edison, in consideration of a fee payable by BioLargo. 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 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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.

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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.

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

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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