Pixium Vision — PRIMAvera implantations now completed

Pixium Vision (PAR: PIX)

Last close As at 12/07/2024

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Research: Healthcare

Pixium Vision — PRIMAvera implantations now completed

Meeting its prior guidance, Pixium Vision has now completed all of the implantations required as part of the PRIMAvera pivotal trial assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). In total, 38 patients have been implanted with the Prima sub-retinal photovoltaic device and Pixium expects to report primary endpoint data around the end of 2023, filing for European approval in H124. We continue to model for EU market approval in H125.

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Pixium Vision

PRIMAvera implantations now completed

PRIMAvera update

Healthcare equipment
and services

15 December 2022

Price

€0.10

Market cap

€7m

$1.07/€

Pro forma estimated net debt (€m) at 30 September 2022 excluding €0.9m in lease liabilities

3.8

Shares in issue

68.2m

Free float

67%

Code

ALPIX

Primary exchange

Euronext Growth Paris

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(13.3)

(53.4)

(87.5)

Rel (local)

(14.7)

(56.6)

(87.0)

52-week high/low

€0.8

€0.1

Business description

Pixium Vision develops bionic vision systems for patients with severe vision loss. Its lead product, Prima, is a wireless subretinal implant system designed for dry age-related macular degeneration. The company recently completed implantations that it started as part of a European pivotal study in early 2021.

Next events

FY22 financial results

February 2023

Analyst

Pooya Hemami, OD, MBA, CFA

+1 646 653 7026

Pixium Vision is a research client of Edison Investment Research Limited

Meeting its prior guidance, Pixium Vision has now completed all of the implantations required as part of the PRIMAvera pivotal trial assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). In total, 38 patients have been implanted with the Prima sub-retinal photovoltaic device and Pixium expects to report primary endpoint data around the end of 2023, filing for European approval in H124. We continue to model for EU market approval in H125.

Year end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/20

2.1

(8.7)

(0.26)

0.0

N/A

N/A

12/21

2.7

(10.9)

(0.23)

0.0

N/A

N/A

12/22e

1.8

(12.3)

(0.21)

0.0

N/A

N/A

12/23e

0.8

(18.1)

(0.26)

0.0

N/A

N/A

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

PRIMAvera also expected to support US pathway

Pixium expects the PRIMAvera data to be play an important role in supporting an eventual US regulatory submission. We believe this suggests Pixium has had positive preliminary discussions with US regulators on the role that PRIMAvera may play for a future US submission. We model that a separate study will be needed for US approval and that the US launch will occur in H226, but we may revisit our assumptions once further clarity on the US commercialisation pathway is provided.

Additional funding anticipated in coming months

Pixium reported a 30 June 2022 gross cash position of €7.22m and €8.38m in total debt, excluding €0.9m in lease liabilities. In Q322 it raised €5.5m (gross) in ESGO convertible notes, reporting a 30 September gross cash position of €8.5m and a Q322 operating cash burn rate of c €3m. Given that €1.6m in ESGO notes have been converted to equity at 12 December, we estimate pro forma Q322 net debt of €3.8m. Pixium believes its current funds should on hand should enable it to finance its operations until middle of the Q223. We believe it is looking to secure additional funding in the coming months and we model that it will raise €40m (modelled as illustrative debt) before the end of FY24.

Valuation: Minor changes to basic equity value/share

Our underlying local-currency operating forecasts are unchanged but we have rolled forward our estimates and adjusted our forex expectations (to $1.07/€ vs parity previously). We now obtain a rNPV of €146.3m, up from €136.5m, resulting in an equity valuation of €142.5m after including €3.8m in net debt, or €2.09 per basic share (vs €2.27 previously), with the lower per share value due to increased shares outstanding following ESGO note conversions. Converting all the remaining outstanding drawn ESGO convertible notes (€3.9m) at €0.10/share would adjust our equity valuation to €1.34/share.

Exhibit 1: Financial summary

€(000)

2018

2019

2020

2021

2022e

2023e

31-December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

1,598

1,782

2,092

2,655

1,844

800

Cost of Sales

(41)

0

0

0

0

0

General & Administrative

(2,019)

(3,572)

(4,008)

(5,084)

(5,147)

(6,204)

Research & Development

(5,297)

(6,563)

(5,704)

(7,282)

(8,786)

(10,800)

EBITDA

 

 

(5,758)

(8,352)

(7,620)

(9,712)

(12,089)

(16,204)

Depreciation

(677)

(448)

(366)

(549)

(403)

(295)

Amortization

0

0

0

0

0

0

Operating Profit (before exceptionals)

 

(6,435)

(8,801)

(7,986)

(10,261)

(12,492)

(16,500)

Exceptionals

(5,859)

(69)

(448)

0

0

0

Other

0

0

0

0

0

0

Operating Profit

(12,294)

(8,870)

(8,434)

(10,261)

(12,492)

(16,500)

Net Interest

(1,277)

(1,006)

(699)

(669)

224

(1,562)

Profit Before Tax (norm)

 

 

(7,712)

(9,806)

(8,685)

(10,930)

(12,268)

(18,061)

Profit Before Tax (FRS 3)

 

 

(13,571)

(9,876)

(9,133)

(10,930)

(12,268)

(18,061)

Tax

0

0

0

0

0

0

Profit After Tax and minority interests (norm)

(7,712)

(9,806)

(8,685)

(10,930)

(12,268)

(18,061)

Profit After Tax and minority interests (FRS 3)

(13,571)

(9,876)

(9,133)

(10,930)

(12,268)

(18,061)

Average Number of Shares Outstanding (m)

18.5

22.3

34.0

48.5

57.2

69.3

EPS - normalised (€)

 

 

(0.42)

(0.44)

(0.26)

(0.23)

(0.21)

(0.26)

EPS - normalised and fully diluted (€)

 

(0.42)

(0.44)

(0.26)

(0.23)

(0.21)

(0.26)

EPS - (IFRS) (€)

 

 

(0.73)

(0.44)

(0.27)

(0.23)

(0.21)

(0.26)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,666

4,507

3,410

2,684

2,176

1,901

Intangible Assets

2,623

2,361

1,727

1,341

1,162

1,162

Tangible Assets

1,042

2,145

1,683

1,343

1,014

739

Current Assets

 

 

17,756

9,107

12,721

16,945

13,360

6,015

Short-term investments

0

0

0

0

0

0

Cash

15,629

6,792

10,566

14,505

9,618

2,361

Other

2,126

2,316

2,155

2,440

3,742

3,654

Current Liabilities

 

 

(2,044)

(2,880)

(3,885)

(6,483)

(6,002)

(2,881)

Creditors

(2,044)

(2,880)

(3,349)

(4,895)

(3,728)

(607)

Short term borrowings

0

0

(536)

(1,588)

(2,274)

(2,274)

Long Term Liabilities

 

 

(8,023)

(7,033)

(7,682)

(7,332)

(13,799)

(26,799)

Long term borrowings

(7,870)

(5,787)

(6,604)

(6,500)

(13,125)

(26,125)

Other long term liabilities

(153)

(1,246)

(1,078)

(832)

(674)

(674)

Net Assets

 

 

11,355

3,700

4,564

5,814

(4,265)

(21,764)

CASH FLOW

Operating Cash Flow

 

 

(6,174)

(7,282)

(6,207)

(8,160)

(13,487)

(18,676)

Net Interest

(1,277)

(1,006)

(699)

(669)

224

(1,562)

Tax

0

0

0

0

0

0

Net Operating Cash Flow

(7,450)

(8,288)

(6,906)

(8,829)

(13,263)

(20,237)

Capex

(31)

(34)

(82)

(48)

(45)

(20)

Acquisitions/disposals

0

0

0

0

0

0

Financing

14,068

2,034

9,055

13,170

1,590

0

Net Cash Flow

6,587

(6,288)

2,067

4,293

(11,718)

(20,257)

Opening net debt/(cash)

 

 

(1,401)

(7,760)

(1,004)

(3,426)

(6,417)

5,781

HP finance leases initiated

0

0

0

0

0

0

Other

(228)

(468)

354

(1,302)

(480)

0

Closing net debt/(cash)

 

 

(7,760)

(1,004)

(3,426)

(6,417)

5,781

26,038

Lease debt

na

1,346

1,258

1,045

900

900

Closing net debt/(cash) inclusive of IFRS16 lease debt

(7,760)

342

(2,168)

(5,372)

6,681

26,938

Source: Edison Investment Research, Company accounts


General disclaimer and copyright

This report has been commissioned by Pixium Vision and prepared and issued by Edison, in consideration of a fee payable by Pixium Vision. Edison Investment Research standard fees are £60,000 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 2022 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

General disclaimer and copyright

This report has been commissioned by Pixium Vision and prepared and issued by Edison, in consideration of a fee payable by Pixium Vision. Edison Investment Research standard fees are £60,000 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 2022 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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