Pixium Vision — Focusing on reaching the PRIMAvera milestone

Pixium Vision (PAR: PIX)

Last close As at 17/07/2024

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Research: Healthcare

Pixium Vision — Focusing on reaching the PRIMAvera milestone

Having completed the required 38 implantations in late 2022, Pixium Vision’s key upcoming clinical milestone is the primary efficacy data, expected in or around year-end 2023, from the PRIMAvera European pivotal study assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company’s FY22 results showed a milder operating loss than expected, coming in at €11.9m, below our €12.5m estimate. Pixium has since taken further steps to curb its cash burn rate, and it now expects its funds on hand (€4.7m gross cash as of 31 March) to last until approximately the end of July, versus its prior guidance of June 2023. It is working actively to raise additional funds and has hired two investment banks to reach potential investors worldwide. We have rolled forward our estimates and given that we expect the company’s focus in 2023 and 2024 will be on preparing the Prima System for EU market approval and launch (which we continue to model in H125), we have pushed back our US commercialisation forecast by one year, to H227. We now obtain a pipeline rNPV valuation of €140.1m (vs €146.3m previously).

Written by

Pooya Hemami

Analyst - Healthcare

Pixium-Vision_resized

Healthcare

Pixium Vision

Focusing on reaching the PRIMAvera milestone

FY22 update

Healthcare equipment
and services

2 May 2023

Price

€0.08

Market cap

€12m

$1.10/€

Pro forma estimated net debt (€m) at 31 March 2023 excluding €0.8m in lease liabilities

3.2

Shares in issue

149m

Free float

N/A

Code

ALPIX

Primary exchange

Euronext Growth Paris

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(28.1)

2.5

(85.1)

Rel (local)

126.1

2.0

(86.8)

52-week high/low

€0.57

€0.03

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 completed implantations in Q422 for the PRIMAvera European pivotal study.

Next events

H123 financial results

August 2023

Analyst

Pooya Hemami, OD, MBA, CFA

+1 646 653 7026

Pixium Vision is a research client of Edison Investment Research Limited

Having completed the required 38 implantations in late 2022, Pixium Vision’s key upcoming clinical milestone is the primary efficacy data, expected in or around year-end 2023, from the PRIMAvera European pivotal study assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company’s FY22 results showed a milder operating loss than expected, coming in at €11.9m, below our €12.5m estimate. Pixium has since taken further steps to curb its cash burn rate, and it now expects its funds on hand (€4.7m gross cash as of 31 March) to last until approximately the end of July, versus its prior guidance of June 2023. It is working actively to raise additional funds and has hired two investment banks to reach potential investors worldwide. We have rolled forward our estimates and given that we expect the company’s focus in 2023 and 2024 will be on preparing the Prima System for EU market approval and launch (which we continue to model in H125), we have pushed back our US commercialisation forecast by one year, to H227. We now obtain a pipeline rNPV valuation of €140.1m (vs €146.3m previously).

Year
end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/21

2.7

(10.9)

(0.23)

0.0

N/A

N/A

12/22

2.0

(10.3)

(0.21)

0.0

N/A

N/A

12/23e

0.8

(13.8)

(0.10)

0.0

N/A

N/A

12/24e

0.8

(13.3)

(0.09)

0.0

N/A

N/A

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

Managing costs as new financing is sought

We continue to view the Prima System as a potentially transformative treatment in GA-AMD given the visual function improvements already shown in the earlier European feasibility study and reinforced by the recent Breakthrough Device designation granted by the FDA. Given FY22 results and the company’s actions to conserve capital, we now estimate an FY23 net operating burn rate of €17.6m (vs €20.2m previously). We assume that any planned studies or activities targeting the US market will be postponed as the company focuses its resources towards obtaining CE Mark and bringing PRIMAvera to European commercialisation.

Valuation: Adjusted to reflect ESGO conversions

Pixium reported a gross debt position of €10.3m at end-FY22 and given a Q123 gross cash position of €4.7m and c €2.4m in ESGO debt converted to equity in the year to date, we estimate €3.2m pro forma (Q123) net debt. We obtain a pipeline rNPV valuation of €140.1m (vs €146.3m previously), resulting in an equity valuation of €136.9m after including net debt, or €0.92 per basic share (vs €2.09 previously), with the lower per share value due to increased shares outstanding following ESGO note conversions. We assume Pixium will require €37m in funding to reach profitability (in FY25) and if this need is met through equity issuances at the current market price (€0.073/share) and if outstanding ESGO debt (€1.25m) is also converted at this price, the resulting equity valuation would be €0.26 per share.

Exhibit 1: Financial summary

€(000)

2018

2019

2020

2021

2022

2023e

2024e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

1,598

1,782

2,092

2,655

1,955

800

800

Cost of Sales

(41)

0

0

0

0

0

0

General & Administrative

(2,019)

(3,572)

(4,008)

(5,084)

(4,650)

(5,398)

(6,628)

Research & Development

(5,297)

(6,563)

(5,704)

(7,282)

(8,793)

(7,800)

(4,500)

EBITDA

 

 

(5,758)

(8,352)

(7,620)

(9,712)

(11,488)

(12,398)

(10,328)

Depreciation

(677)

(448)

(366)

(549)

(456)

(276)

(223)

Amortization

0

0

0

0

0

0

0

Operating Profit (before exceptionals)

 

(6,435)

(8,801)

(7,986)

(10,261)

(11,944)

(12,673)

(10,551)

Exceptionals

(5,859)

(69)

(448)

0

0

0

0

Other

0

0

0

0

0

0

0

Operating Profit

(12,294)

(8,870)

(8,434)

(10,261)

(11,944)

(12,673)

(10,551)

Net Interest

(1,277)

(1,006)

(699)

(669)

1,632

(1,156)

(2,717)

Profit Before Tax (norm)

 

 

(7,712)

(9,806)

(8,685)

(10,930)

(10,312)

(13,830)

(13,268)

Profit Before Tax (FRS 3)

 

 

(13,571)

(9,876)

(9,133)

(10,930)

(10,312)

(13,830)

(13,268)

Tax

0

0

0

0

0

0

0

Profit After Tax and minority interests (norm)

(7,712)

(9,806)

(8,685)

(10,930)

(10,312)

(13,830)

(13,268)

Profit After Tax and minority interests (FRS 3)

(13,571)

(9,876)

(9,133)

(10,930)

(10,312)

(13,830)

(13,268)

Average Number of Shares Outstanding (m)

18.5

22.3

34.0

47.4

48.9

139.1

149.0

EPS - normalised (€)

 

 

(0.42)

(0.44)

(0.26)

(0.23)

(0.21)

(0.10)

(0.09)

EPS - normalised and fully diluted (€)

 

 

(0.42)

(0.44)

(0.26)

(0.23)

(0.21)

(0.10)

(0.09)

EPS - (IFRS) (€)

 

 

(0.73)

(0.44)

(0.27)

(0.23)

(0.21)

(0.10)

(0.09)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,666

4,507

3,410

2,684

2,030

1,774

1,571

Intangible Assets

2,623

2,361

1,727

1,341

983

983

983

Tangible Assets

1,042

2,145

1,683

1,343

1,047

791

588

Current Assets

 

 

17,756

9,107

12,721

16,945

10,344

5,722

16,657

Short-term investments

0

0

0

0

0

0

0

Cash

15,629

6,792

10,566

14,505

7,687

3,065

13,913

Other

2,126

2,316

2,155

2,440

2,657

2,657

2,745

Current Liabilities

 

 

(2,044)

(2,880)

(3,885)

(6,483)

(8,698)

(4,651)

(4,651)

Creditors

(2,044)

(2,880)

(3,349)

(4,895)

(4,374)

(327)

(327)

Short term borrowings

0

0

(536)

(1,588)

(4,324)

(4,324)

(4,324)

Long Term Liabilities

 

 

(8,023)

(7,033)

(7,682)

(7,332)

(6,525)

(19,525)

(43,525)

Long term borrowings

(7,870)

(5,787)

(6,604)

(6,500)

(5,990)

(18,990)

(42,990)

Other long term liabilities

(153)

(1,246)

(1,078)

(832)

(535)

(535)

(535)

Net Assets

 

 

11,355

3,700

4,564

5,814

(2,849)

(16,680)

(29,948)

CASH FLOW

Operating Cash Flow

 

 

(6,174)

(7,282)

(6,207)

(8,160)

(12,960)

(16,445)

(10,415)

Net Interest

(1,277)

(1,006)

(699)

(669)

1,632

(1,156)

(2,717)

Tax

0

0

0

0

0

0

0

Net Operating Cash Flow

(7,450)

(8,288)

(6,906)

(8,829)

(11,328)

(17,601)

(13,132)

Capex

(31)

(34)

(82)

(48)

(92)

(20)

(20)

Acquisitions/disposals

0

0

0

0

0

0

0

Financing

14,068

2,034

9,055

13,170

(927)

0

0

Net Cash Flow

6,587

(6,288)

2,067

4,293

(12,347)

(17,621)

(13,152)

Opening net debt/(cash)

 

 

(1,401)

(7,760)

(1,004)

(3,426)

(6,417)

2,627

20,249

HP finance leases initiated

0

0

0

0

0

0

0

Other

(228)

(468)

354

(1,302)

3,303

0

0

Closing net debt/(cash)

 

 

(7,760)

(1,004)

(3,426)

(6,417)

2,627

20,248

33,401

Lease debt

N/A

1,346

1,258

1,045

765

765

765

Closing net debt/(cash) inclusive of IFRS 16 lease debt

(7,760)

342

(2,168)

(5,372)

3,392

21,013

34,166

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 2023 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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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 2023 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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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