Acarix — The de novo beat

Acarix — The de novo beat

Acarix has announced that the FDA is reviewing a de novo 510(k) application for its innovative CADScor cardiac diagnostic device. This is important news as it could mean that Acarix might enter the US market by 2021 – although it will need marketing alliances and good reimbursement. Given weak European sales and no update on German reimbursement, accessing the large US market could radically transform the business. Acarix might need US clinical data to ensure that it gains Medicare and insurer reimbursement.

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Written by

Acarix

The de novo beat

US regulatory update

Healthcare equipment
& services

3 January 2020

Price

SEK1.37

Market cap

SEK71m

Cash (SEKm) at 30 June 2019

39

Shares in issue

51.7m

Free float (estimated)

76%

Code

ACARIX

Primary exchange

Nasdaq First North Premier

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(23.0)

(38.0)

(58.2)

Rel (local)

(27.7)

(45.8)

(68.4)

52-week high/low

SEK3.58

SEK1.26

Business description

Acarix, a Swedish company with Danish origins, has developed the CE-marked CADScor to help doctors rule out stable coronary artery disease. About half of patients can be ruled out from further expensive testing. Full EU sales could start from 2020, with US sales possible from 2023.

Next events

FY19 results

February 2020

Analyst

Dr John Savin MBA

+44 (0)20 3077 5735

Acarix is a research client of Edison Investment Research Limited

Acarix has announced that the FDA is reviewing a de novo 510(k) application for its innovative CADScor cardiac diagnostic device. This is important news as it could mean that Acarix might enter the US market by 2021 – although it will need marketing alliances and good reimbursement. Given weak European sales and no update on German reimbursement, accessing the large US market could radically transform the business. Acarix might need US clinical data to ensure that it gains Medicare and insurer reimbursement.

Year end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/17

0.64

(30.74)

(1.29)

0.0

N/A

N/A

12/18

1.02

(42.25)

(1.83)

0.0

N/A

N/A

12/19e

2.62

(43.33)

(1.56)

0.0

N/A

N/A

12/20e

4.11

(44.65)

(0.86)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. Average shares changed in October 2019.

A crucial de novo development – outcome mid 2020?

The December 2019 announcement of the FDA’s acceptance of a de novo 510(k) application for regulatory approval raises the strong possibility of a fundamental shift in Acarix’s strategic position. Sales progress in Europe has been hard and painful: German reimbursement remains unclear and the UK is very difficult. The US market offers a major opportunity but Acarix will need marketing partners and will also have to gain Medicare and insurer reimbursement at a price level that drives physician uptake. It may need fresh commercial strategies like device leasing. A weakness in the Acarix case remains the high quality but limited data based only on Danish experience; US data will be very useful in pricing discussions and customer uptake.

The de novo route is available for low to moderate risk devices where there is no comparable diagnostic device. The FDA accepted the application in mid December 2019. Review takes 150 days, but the FDA may ask further questions; if so, there can be a pause of up to 180 days while Acarix responds. Hence, we expect the formal outcome from May 2020 but realistically in H220. If the de novo 510(k) is granted, it sets a new standard and enables competitors to file a 510(k). However, CADScor uses sophisticated algorithms so copying it will not be easy.

Expanding the clinical data package

The new Danish randomised 2,000-patient trial (FILTER-SCAD, NCT04121949) started recruitment in December 2019. The study prospectively compares CADScor to standard evaluation outcomes over 12 months. Data might be announced in H122 assuming full recruitment by late 2020. A meta-analysis of completed studies using 2,245 patients was published in July 2019. In May 2019, the UK health service published an innovation review of CADScor.

Valuation: 2020 value of SEK7.23 per share

Our valuation still assumes 2020 German reimbursement (uncertain) with strong sales from 2021; the sales team has been enlarged. We currently assume US sales from 2023 and the de novo 510(k) could bring this timeframe forward to 2021 – although initial sales are uncertain at present. Our indicative value remains at SEK374m (SEK7.23 per share) pending revision as Acarix updates the market.

Exhibit 1: Financial summary

SEK000s

2017

2018

2019e

2020e

Year end 31 Dec

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

638

1,024

2,623

4,105

Cost of Sales

(208)

(316)

(577)

(874)

Gross Profit

430

708

2,046

3,232

EBITDA

 

 

(29,499)

(41,028)

(41,959)

(43,273)

Operating Profit (before amort. and except.)

 

 

(30,743)

(42,523)

(43,454)

(44,768)

Intangible Amortisation

(1,261)

(1,430)

(1,430)

(1,430)

Exceptionals

-

-

-

-

Operating Profit

(32,004)

(43,953)

(44,884)

(46,198)

Other

-

-

-

-

Net Interest

7

273

120

120

Profit Before Tax (norm)

 

 

(30,736)

(42,250)

(43,334)

(44,648)

Profit Before Tax (FRS 3)

 

 

(30,736)

(42,250)

(43,334)

(44,648)

Tax

960

-

-

-

Profit After Tax (norm)

(29,776)

(42,250)

(43,334)

(44,648)

Profit After Tax (FRS 3)

(29,776)

(42,250)

(43,334)

(44,648)

Average Number of Shares Outstanding (m)

23.0

23.0

27.8

51.7

EPS - normalised (ore)

 

 

(129.31)

(183.48)

(155.85)

(86.37)

EPS - FRS 3 (ore)

 

 

(129.31)

(183.48)

(155.85)

(86.37)

Dividend per share (ore)

0.0

0.0

0.0

0.0

Gross Margin (%)

67.4

69.1

78.0

78.7

EBITDA Margin (%)

(4,624)

(4,007)

(1,600)

(1,054)

Operating Margin (before GW and except.) (%)

(4,819)

(4,153)

(1,657)

(1,091)

BALANCE SHEET

Fixed Assets

 

 

25,191

23,696

22,201

20,706

Intangible Assets

20,351

18,921

17,491

16,061

Tangible Assets

0

0

0

0

Acquired rights

4,840

4,775

4,710

4,645

Current Assets

 

 

108,865

71,501

68,362

25,705

Stocks

1,945

2,625

2,625

2,625

Debtors

2,468

3,857

3,857

3,857

Cash

103,457

65,019

61,880

19,223

Other

995

0

0

0

Current Liabilities

 

 

(5,118)

(7,321)

(7,321)

(7,817)

Creditors

(1,464)

(2,504)

(2,504)

(3,000)

Short term borrowings

0

0

0

0

Short term leases

0

0

0

0

Other

(3,653)

(4,816)

(4,816)

(4,816)

Long Term Liabilities

 

 

0

0

0

0

Long term borrowings

0

0

0

0

Long term leases

0

0

0

0

Other long-term liabilities

0

0

0

0

Net Assets

 

 

128,939

87,876

83,242

38,594

CASH FLOW

Operating Cash Flow

 

 

(41,506)

(39,586)

(41,959)

(42,777)

Net Interest

7

273

120

120

Tax

960

977

0

0

Capex

(2,984)

0

0

0

Acquisitions/disposals

0

0

0

0

Financing

1,203

0

43,000

0

Dividends

0

0

0

0

Other

0

0

(4,300)

0

Net Cash Flow

(42,320)

(38,336)

(3,139)

(42,657)

Opening net debt/(cash)

 

 

(145,895)

(103,457)

(65,019)

(61,881)

HP finance leases initiated

-

-

-

-

Other

(118)

(102)

-

-

Closing net debt/(cash)

 

 

(103,457)

(65,019)

(61,881)

(19,223)

Source: Acarix accounts, Edison Investment Research

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This report has been commissioned by Acarix and prepared and issued by Edison, in consideration of a fee payable by Acarix. 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.

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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

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

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Acarix and prepared and issued by Edison, in consideration of a fee payable by Acarix. 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 Edison analyst 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). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2020. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person

United States

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

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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