Pixium Vision — Q3 results in line, awaiting pivotal study approval

Pixium Vision (PAR: PIX)

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Research: Healthcare

Pixium Vision — Q3 results in line, awaiting pivotal study approval

Pixium Vision provided an update on its 9M20 cash flow results, which are broadly in line with H120 trends. The company reported a 9M20 operating cash outflow of €4.2m and a gross cash position of €13.3m at the end of the quarter. We believe Pixium’s funds on hand should be sufficient to support its ongoing operations into Q421, thus including at least several months of initial ramp-up of the upcoming PRIMAvera pivotal study on the Prima bionic vision system (BVS).

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Pixium Vision

Q3 results in line, awaiting pivotal study approval

Quarterly update

Healthcare equipment
& services

29 October 2020

Price

€0.50

Market cap

€22m

$1.18/€

Net debt (€m) at 30 June 2020 (excluding lease liabilities)

0.9

Shares in issue

42.9m

Free float

60%

Code

PIX

Primary exchange

Euronext Growth Paris

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(6.7)

(1.4)

(12.4)

Rel (local)

(1.2)

5.9

9.4

52-week high/low

€1.1

€0.5

Business description

Pixium Vision develops bionic vision systems for patients with severe vision loss. Its lead product, Prima, is a wireless sub-retinal implant system designed for dry-AMD. The company completed five implantations in an EU feasibility study and recently started a US feasibility study.

Next events

File application to start pivotal study

Q420

36-month data from EU feasibility study

Q121

Analysts

Pooya Hemami, CFA

+1 646 653 7026

Maxim Jacobs, CFA

+1 646 653 7027

Pixium Vision is a research client of Edison Investment Research Limited

Pixium Vision provided an update on its 9M20 cash flow results, which are broadly in line with H120 trends. The company reported a 9M20 operating cash outflow of €4.2m and a gross cash position of €13.3m at the end of the quarter. We believe Pixium’s funds on hand should be sufficient to support its ongoing operations into Q421, thus including at least several months of initial ramp-up of the upcoming PRIMAvera pivotal study on the Prima bionic vision system (BVS).

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/18

1.6

(7.7)

(0.42)

0.0

N/A

N/A

12/19

1.8

(9.8)

(0.44)

0.0

N/A

N/A

12/20e

1.7

(8.6)

(0.28)

0.0

N/A

N/A

12/21e

1.6

(11.0)

(0.25)

0.0

N/A

N/A

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

Awaiting Prima pivotal study regulatory approval

Pixium continues to expect European regulatory approval to begin the pivotal study before year-end 2020. We expect implantations for this registration-enabling study will start in H121 and could lead to EU commercialisation in H223. Pixium is in discussions with regulatory authorities to explore the possibility of conducting this study in parallel in Europe and the US, which, if accepted by the FDA, could lead to a US launch earlier than our baseline estimate of H225.

Targeting severe dry-AMD patients

Prima seeks to address a largely unmet market indication, advanced dry age-related macular degeneration involving geographic atrophy. 18-month data from the European feasibility study suggest that the Prima system, enhanced with second-generation augmented reality (AR) glasses and improved analytics, can provide between three and seven lines of improvement on the Landolt visual acuity (VA) scale. We believe this level of amelioration should provide functional benefits (such as recognizing shapes and symbols) and potentially improve patient independence.

Valuation: Raising rNPV to €115.4m

We have updated our valuation by rolling forward our estimates and adjusting our FX assumptions (to use a $1.18/€ rate versus our prior $1.12/€ assumption). Our sales forecasts and post-2021 expense assumptions in local currencies are unchanged. We now obtain a pipeline rNPV (enterprise value excluding net cash) of €115.4m versus €105.9m previously. After including €5.5m in estimated Q320 pro forma net cash (excluding lease liabilities), we obtain an equity valuation of €120.9m, or €2.82 per share (versus €2.73 previously). We continue to assume that Pixium will need to raise €37.5m in funds between Q420 and year-end 2023, modelled as illustrative debt, to bring Prima to commercial launch. We expect that part of this requirement will be fulfilled using the remaining (or unused) €6.25m in tranches from the ESGO funding facility.

Financials review

Pixium’s operating cash flows were generally in line with H120 trends. As stated in our June Outlook report, the COVID-19 pandemic resulted in a pause in R&D, clinical activities and other operating expenses in H120. While many activities have since resumed, including the European Prima feasibility trial (PRIMA-FS), announced on 8 June, with further visual rehabilitation of implanted patients, the end-result was a significant year-on-year decrease in operating cash outflow. The 9M20 operating cash flow loss was €4.21m, a 45% y-o-y decrease. Given that the reported H120 operating cash flow loss was reported as €2.79m, we estimate that the Q320 operating cash outflow was c €1.42m. We expect that Q420 expenses will trend higher than Q320 given the gradual winding up to a more normalised expense run rate for Pixium as of mid-year 2020. After making minor adjustments to our H220 and 2021 forecasts, we estimate that the firm’s 2020 operating cash burn rate (excluding net interest) will be €6.2m and that the 2021 operating cash burn rate will be €9.7m.

As highlighted in our July flash note, Pixium was very active on the financing front in Q320. In addition to completing a €7.3m (gross) capital increase (14.68m shares at €0.50/share) in July, the company took out a €2.5m state-guaranteed loan (from Bpifrance and Pixium’s commercial bank, CIC), along with €2.3m in a repayable advance and a further €0.5m grant (both in connection with the ‘Sight Again’ research funding programme supported by Bpifrance). Pixium also repaid its entire venture loan liability to Kreos Capital, which we estimate at c €2m (the precise payment or liability was not specified). Altogether, the company’s gross cash balance at 30 September 2020 was €13.3m. We believe these funds on hand are sufficient to support Pixium’s ongoing operations into Q421, thus including at least a few months of initial ramp-up of the upcoming PRIMAvera pivotal study. In addition, the company still has €6.25m in unused tranches available from the ESGO funding facility and management states that its cash on hand plus the ESGO financing will allow Pixium to be financed at least until the end of 2021.

The company did not provide an updated account of its formal balance sheet liabilities as of Q320, so our estimate for Q320 net cash is subject to uncertainty. We estimate Q320 pro forma gross debt at c €7.8m, by starting with our assumed H120 gross debt of €5.86m (excluding €1.2m in lease liabilities) and adding the €2.5m state-guaranteed loan and €2.3m repayable advance, and then subtracting the c €2m Kreos liability (due to the repayment) and also reducing the outstanding ESGO convertible debt by €0.88m (given that between 30 June and 12 October, approximately this amount has been converted to equity). After including Q320 gross cash of €13.3m, we estimate Q320 pro forma net cash of c €5.5m.

We continue to assume that Pixium will need to raise €37.5m in funds between Q420 and year-end 2023, modelled as illustrative long-term debt, to complete the PRIMAvera pivotal study, all EU-related regulatory and preparatory commercial activities, and bring Prima to commercial launch. We expect that part of this requirement will be fulfilled using the remaining (or unused) €6.25m in tranches from the ESGO funding facility. All together, we model that Pixium will raise a further €2.5m in the remaining months of 2020, €12.5m in both 2021 and 2022, and €10m in 2023 (all these amounts are shown as long-term debt for illustrative purposes).

Valuation

Our valuation of Pixium Vision is based on an rNPV approach, employing a 12.5% cost of capital, based on the Prima opportunity in dry age-related macular degeneration (AMD). We continue to apply a 20% probability of success estimate for Prima in AMD in our model. We have updated our valuation by rolling forward our estimates and adjusting our FX assumptions (to use a $1.18/€ rate versus our prior $1.12/€ assumption). Our sales forecasts and post-2021 expense assumptions in local currencies are unchanged. We now obtain a pipeline rNPV (enterprise value excluding net cash) of €115.4m versus €105.9m previously.

After including €5.5m in estimated Q320 net cash (excluding lease liabilities), we obtain an equity valuation of €120.9m, or €2.82 per share (versus €2.73 previously).

Exhibit 1: Pixium Vision rNPV assumptions

Product contribution

Indication

Status

NPV (€m)

Probability of success

rNPV (€m)

rNPV/
share (€)

Launch year

Peak WW sales (€m)

Prima (net of R&D and SG&A costs)

Age-related macular degeneration with geographic atrophy

Human feasibility trials

1,017.7

20%

196.5

4.58

H223 (EU) and H225 (US)

1,046 in 2029

Net capex, NWC & taxes

(377.7)

(81.1)

(1.89)

Total

639.9

115.4

2.69

Pro-forma net cash (Q320e) including subsequent debt conversions

5.5

5.5

0.13

Total equity value

645.4

120.9

2.82

FD shares outstanding (000) (30 September 2020)

42,916

Source: Edison Investment Research

Exhibit 2: Financial summary

(€000)

2017

2018

2019

2020e

2021e

2022e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

2,535

1,598

1,782

1,700

1,600

1,600

Cost of Sales

(1,124)

(41)

0

0

0

0

General & Administrative

(5,324)

(2,019)

(3,815)

(2,889)

(2,961)

(3,835)

Research & Development

(7,817)

(5,297)

(6,320)

(6,260)

(8,000)

(10,400)

EBITDA

 

 

(11,731)

(5,758)

(8,352)

(7,449)

(9,361)

(12,635)

Depreciation

(936)

(677)

(448)

(426)

(480)

(580)

Amortization

0

0

0

0

0

0

Operating Profit (before exceptionals)

 

(12,666)

(6,435)

(8,801)

(7,875)

(9,841)

(13,215)

Exceptionals

0

(5,859)

(69)

0

0

0

Other

0

0

0

0

0

0

Operating Profit

(12,666)

(12,294)

(8,870)

(7,875)

(9,841)

(13,215)

Net Interest

(876)

(1,277)

(1,006)

(740)

(1,147)

(2,210)

Profit Before Tax (norm)

 

 

(13,542)

(7,712)

(9,806)

(8,616)

(10,989)

(15,425)

Profit Before Tax (FRS 3)

 

 

(13,542)

(13,571)

(9,876)

(8,616)

(10,989)

(15,425)

Tax

0

0

0

0

0

0

Profit After Tax and minority interests (norm)

(13,542)

(7,712)

(9,806)

(8,616)

(10,989)

(15,425)

Profit After Tax and minority interests (FRS 3)

(13,542)

(13,571)

(9,876)

(8,616)

(10,989)

(15,425)

Average Number of Shares Outstanding (m)

13.3

18.5

22.3

31.0

43.3

44.1

EPS - normalised (€)

 

 

(1.02)

(0.42)

(0.44)

(0.28)

(0.25)

(0.35)

EPS - normalised and fully diluted (€)

 

(1.02)

(0.42)

(0.44)

(0.28)

(0.25)

(0.35)

EPS - (IFRS) (€)

 

 

(1.02)

(0.73)

(0.44)

(0.28)

(0.25)

(0.35)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

9,649

3,666

4,507

4,021

3,765

3,228

Intangible Assets

7,680

2,623

2,361

2,268

2,268

2,268

Tangible Assets

1,970

1,042

2,145

1,753

1,497

961

Current Assets

 

 

14,241

17,756

9,107

15,215

16,691

14,865

Short-term investments

0

0

0

0

0

0

Cash

10,532

15,629

6,792

13,276

14,714

12,887

Other

3,710

2,126

2,316

1,939

1,978

1,978

Current Liabilities

 

 

(2,752)

(2,044)

(2,880)

(2,203)

(1,360)

(1,360)

Creditors

(2,752)

(2,044)

(2,880)

(2,203)

(1,360)

(1,360)

Short term borrowings

0

0

0

0

0

0

Long Term Liabilities

 

 

(9,302)

(8,023)

(7,033)

(11,396)

(23,896)

(36,396)

Long term borrowings

(9,130)

(7,870)

(5,787)

(10,282)

(22,782)

(35,282)

Other long term liabilities

(172)

(153)

(1,246)

(1,114)

(1,114)

(1,114)

Net Assets

 

 

11,836

11,355

3,700

5,636

(4,801)

(19,663)

CASH FLOW

Operating Cash Flow

 

 

(10,605)

(6,174)

(7,282)

(6,218)

(9,691)

(12,073)

Net Interest

(876)

(1,277)

(1,006)

(740)

(1,147)

(2,210)

Tax

0

0

0

0

0

0

Capex

(191)

(31)

(34)

(222)

(224)

(44)

Acquisitions/disposals

0

0

0

0

0

0

Financing

519

14,068

2,034

10,567

0

0

Net Cash Flow

(11,153)

6,587

(6,288)

3,387

(11,062)

(14,327)

Opening net debt/(cash)

 

 

(12,911)

(1,401)

(7,760)

(1,004)

(2,994)

8,069

HP finance leases initiated

0

0

0

0

0

0

Other

(357)

(228)

(468)

(1,397)

0

0

Closing net debt/(cash)

 

 

(1,401)

(7,760)

(1,004)

(2,994)

8,069

22,395

Lease debt

N/A

N/A

1,346

1,215

1,215

1,215

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

(1,401)

(7,760)

342

(1,779)

9,283

23,610

Source: Company accounts, Edison Investment Research


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 £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 2020 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

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 £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 2020 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

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