Pixium Vision — PRIMAvera recruitment timing pushed out

Pixium Vision (PAR: PIX)

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Research: Healthcare

Pixium Vision — PRIMAvera recruitment timing pushed out

Pixium has announced that given longer than expected regulatory approvals for the PRIMAvera European pivotal study due to COVID-19 and delayed clinical centre openings, it now expects to complete recruitment by year-end 2022 (versus its prior guidance of year-end 2021) and plans to report top-line, 12-month data around the end of 2023. We have pushed back our timelines for European and US launches of Prima by one year, to H125 and H226, respectively, hence our valuation has declined.

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Pixium Vision

PRIMAvera recruitment timing pushed out

Clinical study guidance update

Healthcare equipment
& services

15 December 2021

Price

€0.83

Market cap

€49m

$1.13/€

Net cash (€m) at 30 June 2021 (excluding lease liabilities and July 2021 fund-raising)

0.65

Shares in issue

58.5m

Free float

60%

Code

ALPIX

Primary exchange

Euronext Growth Paris

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(18.7)

(17.9)

13.9

Rel (local)

(16.0)

(20.0)

(6.9)

52-week high/low

€2.09

€0.63

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 started implantations as part of a European pivotal study in early 2021.

Next events

FY21 financial results

February 2022

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 has announced that given longer than expected regulatory approvals for the PRIMAvera European pivotal study due to COVID-19 and delayed clinical centre openings, it now expects to complete recruitment by year-end 2022 (versus its prior guidance of year-end 2021) and plans to report top-line, 12-month data around the end of 2023. We have pushed back our timelines for European and US launches of Prima by one year, to H125 and H226, respectively, hence our valuation has declined.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/19

1.8

(9.8)

(0.44)

0.0

N/A

N/A

12/20

2.1

(8.7)

(0.26)

0.0

N/A

N/A

12/21e

2.6

(10.8)

(0.22)

0.0

N/A

N/A

12/22e

1.6

(11.0)

(0.19)

0.0

N/A

N/A

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

Management confident in new PRIMAvera timelines

PRIMAvera is a registration-enabling study designed to assess the Prima wireless bionic vision system (BVS) in 38 patients with severe geographic atrophy due to age-related macular degeneration (GA-AMD). The study began in Q420 and the first implantation occurred in France in March 2021. Implantations in H121 were slower than the company expected due to COVID-19 and related restrictions on elective procedures, as well as the associated delays for gaining additional competent authority approvals and clinical site inclusions. Fortunately, the pace of recruitment has picked up in recent months as new sites have opened. Study sites now include seven locations in France and six in Germany. The company announced the first implantation at Moorfields Eye hospital in London, UK, and expects to add additional sites in Spain, the Netherlands and Italy in H122.

Revising commercialisation timelines

Assuming no significant new COVID-19 restrictions affect the European study sites, we are confident that Pixium can meet its revised timelines, given the number of sites that have joined the PRIMAvera study in H221 and the future expected study location additions. We now anticipate primary 12-month data in late 2023 or early 2024, leading to CE Mark submission in H124 and European approval in H125 (vs H124 previously). We continue to anticipate that a separate study will be needed for US approval, and we model that the US launch will occur in H226 (vs H225 previously).

Valuation: Revised to reflect new launch timing

After adjusting for forex and our new timing assumptions, we obtain a pipeline rNPV of €115.1m (vs €134.2m previously). After adding €8.5m in Q321e net cash, we obtain an equity value of €123.6m (€2.11 per basic share). The company believes its current funds can maintain operations through Q422. We increased our projected total financing need by €15m given the additional time it would take to reach commercialisation. We now expect Pixium will raise €44.4m by year-end 2025 and have modelled a €12.5m raise in 2022 (all modelled as illustrative debt).

Financials

Given our new launch timing estimates, our financial forecasts for Prima sales have been revised, and are shown below.

Exhibit 1: Financial forecast for Prima in GA-AMD

2025e

2026e

2027e

2028e

2029e

Europe

EU patients with Dry AMD with GA (000)

1,595

1,617

1,640

1,663

1,686

Percentage with 20/400 or worse visual acuity

15.0%

15.0%

15.0%

15.0%

15.0%

Percentage meeting all Prima eligibility criteria

30.0%

30.0%

30.0%

30.0%

30.0%

GA-AMD patients meeting all Prima eligibility criteria (000)

71.8

72.8

73.8

74.8

75.9

Prima unit sales in EU

561

1,326

2,685

4,049

5,148

Average revenue per treatment (€)

81,099

82,725

84,341

85,997

87,688

Total EU revenue (€000) for PRIMA-AMD

45,496

109,696

226,489

348,234

451,404

United States

US patients with Dry AMD with GA (000)

1,341

1,367

1,395

1,423

1,451

Percentage with 20/400 or worse visual acuity

15.0%

15.0%

15.0%

15.0%

15.0%

Percentage meeting all Prima eligibility criteria

30.0%

30.0%

30.0%

30.0%

30.0%

GA-AMD patients meeting all Prima eligibility criteria (000)

60.3

61.5

62.8

64.0

65.3

Prima unit sales in US

-

215

889

2,010

3,343

Average revenue per treatment ($)

N/A

112,000

113,558

115,784

118,048

Total US revenue ($000) for PRIMA-AMD

-

24,080

100,985

232,744

394,680

Assumed $/€ rate

1.13

1.13

1.13

1.13

1.13

Worldwide total revenue (€000)

45,496

131,006

315,857

554,202

800,678

Source: Edison Investment Research

Pixium had an H121 net cash position of €0.65m (€10.13m in gross cash and €9.48m gross debt), excluding €1.1m in lease liabilities. The company raised €8m (€7.376m net) through a capital increase in July 2021, resulting in the issuance of 8.097m shares and 4.0486m warrants, as well as converting c €1.1m of its European Select Growth Opportunities Fund (ESGO) convertible financing debt into equity. Pixium reported a 30 September 2021 gross cash position of €16.9m. Given the reduction in ESGO debt since H121 described above, we estimate Q321 gross debt of c €8.4m and hence we estimate Q321 net cash of €8.5m.

As PRIMAvera timelines have been extended, we have pushed back some of our R&D expense forecasts, leading to lower R&D spending in FY22 than previously expected (€7.2m vs €10.4m). We have also pushed back our anticipated start time of a separate US Prima pivotal study from FY22 into FY23. Our FY23 R&D cost estimates are slightly lowered (to €9.4m from €9.8m previously) as cost reductions from the timing change of the US pivotal study offset the effects of continued PRIMAvera activity through FY23. Our estimated 2021 net operating cash burn rate of €11.7m is unchanged, but we now expect a 2022 operating cash burn rate of €8.0m (vs €11.2m previously).

However, given the additional time it will take for Prima to reach commercialisation, we have also increased our projected total financing need by €15m. We now expect Pixium will raise €44.4m (modelled as illustrative debt) by year-end 2025 (up from €29.4m by year-end 2023), to complete the PRIMAvera study and all EU-related regulatory and preparatory commercial activities to bring Prima to commercial launch.

Valuation

Our valuation for Pixium Vision uses an rNPV approach, employing a 12.5% cost of capital, based on the Prima opportunity in GA-AMD. We continue to apply a 25% probability of success estimate for Prima in Europe and a 20% probability in the US market.

Exhibit 2: Pixium Vision rNPV assumptions

Product contribution

Indication

Status

NPV
(€m)

Probability of success

rNPV
(€m)

rNPV/
share (€)

Launch year

Peak sales (€m) in 2030

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

Age-related macular degeneration with geographic atrophy

Pivotal study

540.6

25.00%

121.8

2.08

H125

474

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

Age-related macular degeneration with geographic atrophy

Human feasibility trials

394.9

20.00%

81.0

1.39

H226

477

Net capex, NWC & taxes (global)

(354.3)

(87.7)

(1.50)

Total

581.2

115.1

1.97

Net cash (Q321e)

8.5

8.5

0.15

Total equity value

589.7

123.6

2.11

Basic shares outstanding (000)

58,490

Source: Edison Investment Research

After adjusting for forex and our new timing assumptions, we obtain a pipeline rNPV of €115.1m (vs €134.2m previously). After adding €8.5m in estimated Q321 net cash, we obtain an equity value of €123.6m, or €2.11 per basic share (vs €2.45 previously). Assuming full exercise of the July 2021 warrants, our fully diluted equity valuation would be €2.06 per share (versus €2.37 previously).

Below we provide a sensitivity analysis demonstrating how our per basic share valuation would be affected by using different Prima pricing and probability of success assumptions (for Europe).

Exhibit 3: Pixium Vision per-share equity value (€) analysis based on European net Prima pricing versus probability of success in Europe

70,000

75,000

80,000

85,000

90,000

15.0%

1.01

1.11

1.20

1.30

1.39

20.0%

1.40

1.53

1.66

1.78

1.91

25.0%

1.80

1.96

2.11

2.27

2.43

30.0%

2.20

2.39

2.57

2.76

2.95

35.0%

2.60

2.82

3.04

3.26

3.48

Source: Edison Investment Research. Note: Left-hand column represents European probability of success and top row represents European net Prima pricing at launch (€).


Exhibit 4: Financial summary

€’000s

2018

2019

2020

2021e

2022e

2023e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

1,598

1,782

2,092

2,601

1,600

800

Cost of Sales

(41)

0

0

0

0

0

General & Administrative

(2,019)

(3,572)

(4,017)

(4,785)

(4,000)

(5,000)

Research & Development

(5,297)

(6,563)

(5,711)

(7,092)

(7,200)

(9,400)

EBITDA

 

 

(5,758)

(8,352)

(7,636)

(9,276)

(9,600)

(13,600)

Depreciation

(677)

(448)

(366)

(443)

(447)

(338)

Amortization

0

0

0

0

0

0

Operating Profit (before exceptionals)

 

(6,435)

(8,801)

(8,003)

(9,719)

(13,247)

(10,047)

Exceptionals

(5,859)

(69)

(448)

(624)

0

0

Other

0

0

0

0

0

0

Operating Profit

(12,294)

(8,870)

(8,450)

(10,343)

(10,047)

(13,938)

Net Interest

(1,277)

(1,006)

(700)

(1,043)

(990)

(1,996)

Profit Before Tax (norm)

 

 

(7,712)

(9,806)

(8,703)

(10,762)

(11,037)

(15,935)

Profit Before Tax (FRS 3)

 

 

(13,571)

(9,876)

(9,150)

(11,386)

(11,037)

(15,935)

Tax

0

0

0

0

0

0

Profit After Tax and minority interests (norm)

(7,712)

(9,806)

(8,703)

(10,762)

(14,252)

(11,037)

Profit After Tax and minority interests (FRS 3)

(13,571)

(9,876)

(9,150)

(11,386)

(14,252)

(16,593)

Average Number of Shares Outstanding (m)

18.5

22.3

34.0

48.1

58.5

58.5

EPS - normalised (€)

 

 

(0.42)

(0.44)

(0.26)

(0.22)

(0.19)

(0.27)

EPS - normalised and fully diluted (€)

 

 

(0.42)

(0.44)

(0.26)

(0.22)

(0.19)

(0.27)

EPS - (IFRS) (€)

 

 

(0.73)

(0.44)

(0.27)

(0.24)

(0.19)

(0.27)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,666

4,507

3,411

2,898

2,495

2,176

Intangible Assets

2,623

2,361

1,727

1,534

1,534

1,534

Tangible Assets

1,042

2,145

1,684

1,364

961

643

Current Assets

 

 

17,756

9,107

12,721

15,260

19,751

13,155

Short-term investments

0

0

0

0

0

0

Cash

15,629

6,792

10,566

11,929

16,420

9,911

Other

2,126

2,316

2,155

3,332

3,332

3,244

Current Liabilities

 

 

(2,044)

(2,880)

(3,795)

(4,946)

(7,246)

(4,061)

Creditors

(2,044)

(2,880)

(3,260)

(2,553)

(4,853)

(1,668)

Short term borrowings

0

0

(536)

(2,394)

(2,394)

(2,394)

Long Term Liabilities

 

 

(8,023)

(7,033)

(7,851)

(7,008)

(19,508)

(31,382)

Long term borrowings

(7,870)

(5,787)

(6,695)

(5,989)

(18,489)

(30,363)

Other long-term liabilities

(153)

(1,246)

(1,157)

(1,019)

(1,019)

(1,019)

Net Assets

 

 

11,355

3,700

4,485

6,204

(4,509)

(20,112)

CASH FLOW

Operating Cash Flow

 

 

(6,174)

(7,282)

(6,206)

(10,627)

(6,975)

(16,366)

Net Interest

(1,277)

(1,006)

(700)

(1,043)

(990)

(1,996)

Tax

0

0

0

0

0

0

Net Operating Cash Flow

(7,450)

(8,288)

(6,906)

(11,670)

(7,965)

(18,363)

Capex

(31)

(34)

(82)

(57)

(44)

(20)

Acquisitions/disposals

0

0

0

0

0

0

Financing

14,068

2,034

9,055

14,324

0

0

Net Cash Flow

6,587

(6,288)

2,068

2,597

(8,009)

(18,383)

Opening net debt/(cash)

 

 

(1,401)

(7,760)

(1,004)

(3,336)

(3,546)

4,463

HP finance leases initiated

0

0

0

0

0

0

Other

(228)

(468)

264

(2,387)

0

0

Closing net debt/(cash)

 

 

(7,760)

(1,004)

(3,336)

(3,546)

4,463

22,846

Lease debt

N/A

1,346

1,258

1,141

1,141

1,141

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

(7,760)

342

(2,078)

(2,405)

8,819

27,860

Source: Company reports, 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 £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.

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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.

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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

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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Sequana Medical — DSR reduces congestion in heart failure

Sequana Medical recently announced positive interim data on six patients in its two-phase SAHARA DESERT study in decompensated heart failure (HF) patients with persistent congestion despite maximal diuretic therapy. While the sample size is small, alfapump DSR was shown to eliminate persistent congestion, restore normal bodily fluid volume and improve diuretic response. The market need for improved HF congestion control is significant, given that there are over one million hospitalisations in the United States annually relating to HF, with c 90% relating to fluid overload (congestion). Sequana expects to report top line data from both phases of the study in H222, which should provide further insight into how effectively once-monthly maintenance DSR therapy can sustain the treatment effect.

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