BioPorto Diagnostics — Record setting NGAL sales

BioPorto Diagnostics (OMX: BIOPOR)

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Research: Healthcare

BioPorto Diagnostics — Record setting NGAL sales

BioPorto reported a major increase in Q220 sales for the NGAL research use only (RUO) test, to DKK5.0m, up from DKK3.8m in Q219. This is the single highest quarter for NGAL RUO sales, and uptake in the US has been especially strong, up 95% y-o-y. Sales for the company’s other products were down (DKK1.7m, from DKK4.0m in Q219) reflecting the company’s shift in focus to NGAL. Although RUO NGAL sales remain relatively small, they represent the beachhead for the eventual launch of the FDA-cleared NGAL Test, which we expect to have first commercial sales in 2021.

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Written by

Healthcare

BioPorto Diagnostics

Record setting NGAL sales

Earnings update

Healthcare equipment
& services

20 August 2020

Price

DKK2.52

Market cap

DKK504m

DKK6.63/US$

Net cash (DKKm) at 30 June 2020

30.3

Shares in issue

199.9m

Free float

82.1%

Code

BIOPOR

Primary exchange

Nasdaq Copenhagen

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(4.2)

(8.4)

(7.8)

Rel (local)

(4.5)

(16.4)

(28.2)

52-week high/low

DKK3.29

DKK1.68

Business description

BioPorto Diagnostics is a diagnostic company focused on the development and commercialisation of biomarker-based assays. The company’s portfolio includes The NGAL Test, for prediction of acute kidney injury, and an extensive antibody library.

Next events

Paediatric NGAL submission

H220

Adult NGAL submission

2021

Analyst

Nathaniel Calloway

+1 646 653 7036

BioPorto Diagnostics is a research client of Edison Investment Research Limited

BioPorto reported a major increase in Q220 sales for the NGAL research use only (RUO) test, to DKK5.0m, up from DKK3.8m in Q219. This is the single highest quarter for NGAL RUO sales, and uptake in the US has been especially strong, up 95% y-o-y. Sales for the company’s other products were down (DKK1.7m, from DKK4.0m in Q219) reflecting the company’s shift in focus to NGAL. Although RUO NGAL sales remain relatively small, they represent the beachhead for the eventual launch of the FDA-cleared NGAL Test, which we expect to have first commercial sales in 2021.

Year end

Revenue (DKKm)

PBT*
(DKKm)

EPS*
(DKK)

DPS
(DKK)

P/E
(x)

Yield
(%)

12/18

26.0

(42.5)

(0.24)

0.0

N/A

N/A

12/19

26.6

(71.1)

(0.39)

0.0

N/A

N/A

12/20e

26.5

(69.9)

(0.34)

0.0

N/A

N/A

12/21e

102.3

(16.1)

(0.08)

0.0

N/A

N/A

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

Paediatric NGAL study started

The company announced in late June 2020 that it had initiated the pivotal clinical study for the paediatric NGAL test for the risk assessment of acute kidney injury (AKI) in critically ill children. We are pleased to see that enrolment has started, following earlier delays due to COVID-19. The trial should be quick, and the company is targeting a submission of an application to the FDA by the end of 2020.

COVID-19 test moving forward

After the paediatric submission, the company’s next highest priority is its COVID-19 diagnostic test development. The company announced that it will be developing two tests for COVID-19: an antigen test to identify active disease (which was previously announced) and a serology test to assess exposure. Both tests will be designed around the company’s rapid, point-of-care testing platform, gRAD. The company is in the final stages of antibody selection for the antigen test and expects to test the product against live virus soon, as well as have initial discussions with the FDA.

More cash sought before year end

BioPorto recently completed a rights offering that raised a net DKK37.9m (25.0m shares), and it reported that it ended the period with DKK30.3m cash. The company however noted with Q2 earnings that it intends to seek additional capital in 2020 to support the 2021 launch of the NGAL test. The company has guided to an EBIT loss of DKK73m for 2020, which is roughly consistent with our estimates.

Valuation: Unchanged at DKK896m or DKK4.48/share

Our valuation remains unchanged at DKK896m or DKK4.48 per basic share, because the impact of rolling forward our NPVs is offset by lower net cash and an increase to operational costs. We forecast that the company will need at least DKK20m in additional capital to reach profitability.

NGAL RUO sales almost double

BioPorto reported sales of DKK5.0m from the RUO NGAL test for Q220. This is a 30% increase over Q219 (DKK3.8m), but the Q219 figure also included DKK1.2m in NGAL licensing fees. On the basis of end-user sales, Q220 is up 90%. Sales grew both in the US (DKK1.4m, 95% increase) and in RoW (DKK3.6m, 85% increase). Conversely, sales of the company’s other research products continue to decline and totalled DKK1.7m for the quarter, down from DKK4.0 in Q219. This is a strategic move on the part of the company as it shifts its resources towards promoting the NGAL test. We forecast relatively flat RUO sales going forward. Overall, company revenue was down in Q220: DKK6.7 compared to DKK7.8 for Q219. Across research products, we forecast approximately DKK27m in revenue for 2020, which is slightly lower than company guidance of DKK30m. We continue to be encouraged by growth in this product and see it as an indication of increased interest in NGAL as a biomarker for acute kidney injury. We expect this interest to translate into sales of the FDA-cleared test following its launch in 2021.

Exhibit 1: BioPorto NGAL product sales

Source: BioPorto reports. Note: Does not include licensing revenue.

Research programmes moving forward

BioPorto’s main operational focus continues to be advancement of the NGAL test towards marketing clearance in the US. To this end, it recently initiated the pivotal clinical study of the product in paediatric patients in June 2020. We are pleased to see the trial start to enrol patients because it was previously delayed on account of the COVID-19 pandemic. The company expects the trial to be completed in H220 with enough time for it to submit a De Novo application to the FDA by the end of 2020. The FDA will have a statutory review time of 150 days following submission, so we expect a clearance decision on the product in H121. The goal is then to use the paediatric test as a predicate device for submission of a 510(k) application for the adult test, but the timelines for this submission are contingent on the results of the review of the paediatric test and other communications from the FDA. We currently forecast submission of an application for the adult test later in 2021.

In addition to the NGAL programme, BioPorto has recently started a collaboration with the University of Southern Denmark (SDU) to co-develop tests to detect COVID-19. The company recently announced that it would be developing two such tests: the previously announced antigen test to detect active infections, as well as a serological test to detect antibodies generated by a previous exposure. However, the antigen test remains BioPorto’s main focus. It provided an update on the programme and noted that it has finalised the selection of the antibodies that will be used in the antigen test, and once this selection is complete it can move forward on testing it with live virus and patient samples. The company stated that pilot study of the antigen test could begin in the US as early as Q320. Both the antigen test and the serological test will employ the company’s gRAD device, a modular implementation of a traditional point-of-care, lateral flow test (ie a dipstick). The goal is to provide a semi-quantitative test similar to a pregnancy test (ie without the need for complex instrumentation) that can be used at the bedside or doctor’s office and provide COVID-19 testing results in minutes.

Finally, BioPorto announced that it is developing a gRAD implementation of the NGAL test called NGALds (for dipstick). The company has noted that it will be submitting it for CE marking by the end of 2020 and plans to start selling the product in select countries in Europe in 2021 (although we do not expect revenue from the product to be significant before any clinical studies). Like the COVID-19 tests in development, this would allow testing for kidney injury at the point of care and could provide results very quickly. We can envision how this product could be particularly useful in settings outside the hospital, which include doctors’ offices or in triage settings such as an ambulance.

Valuation

Our valuation remains unchanged at DKK896m or DKK4.48 per basic share. We have rolled forward our NPVs, but this effect was offset by lower net cash and an increase in unallocated costs (DKK210m from DKK188m). The increase in unallocated costs is driven by increases to our near-term operational spending to reflect current trends. We have increased our expected reported PBT loss for 2020 to DKK74m from DKK66m. Additionally, we have adjusted the valuation for the research products based on Q220 results, which has increased the valuation of the NGAL RUO test (DKK8.4m from DKK5.7m) and decreased the value of other research products (DKK2.3m from DKK3.0m).

BioPorto ended the quarter with DKK30.3m in net cash following the completion of its rights offering, which raised DKK37.9m (net) from 25.0m shares. We model that this should be sufficient to finance operations through the end of 2020, but the company noted that it intends to raise additional capital during the year to support operations beyond that point. We currently forecast that it will need a minimum of DKK20m (which we include as illustrative debt in 2020) to reach profitability in 2022 driven by commercial NGAL sales, and after which we do not expect it to need additional capital. This number may increase if the company experiences any delays in the FDA clearance of the NGAL test for either paediatrics or adults.

Exhibit 2: Valuation of BioPorto

Programme

Market

Probability of success

Peak revenue ($m)

Valuation (DKKm)

The NGAL Test

ICU

50%

180.8

671.9

ED

30%

167.1

295.5

Post-surgery

30%

54.1

84.8

Research

100%

4.0

8.4

Paediatrics

50%

15.9

12.8

Other products

Research

100%

1.3

2.3

Unallocated costs

(209.8)

Total

865.9

Net cash and equivalents (Q220) (DKKm)

30.3

Total firm value (DKKm)

896.2

Total shares (m)

199.9

Value per share (DKK)

4.48

Dilutive warrants (m)

14.1

Total diluted shares (m)

214.0

Value per diluted share (DKK)

4.42

Source: BioPorto reports, Edison Investment Research

Exhibit 3: Financial summary

DKK'000s

2018

2019

2020e

2021e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

INCOME STATEMENT

Revenue

 

 

26,016

26,622

26,529

102,266

Cost of Sales

(8,181)

(9,293)

(11,260)

(16,368)

Gross Profit

17,835

17,329

15,268

85,897

Sales

(20,935)

(39,268)

(30,527)

(45,274)

R&D

(18,676)

(24,556)

(31,047)

(33,560)

Administrative

(20,005)

(27,804)

(27,537)

(27,812)

EBITDA

 

 

(42,103)

(68,333)

(65,514)

(14,221)

Operating Profit (before amort. and except.)

 

 

(42,646)

(71,190)

(69,316)

(16,223)

Amortisation of acquired intangibles

0

0

0

0

Exceptionals

0

0

0

0

Share-based payments

865

(3,109)

(4,526)

(4,526)

Reported operating profit

(41,781)

(74,299)

(73,842)

(20,749)

Net Interest

164

52

(620)

100

Joint ventures & associates (post tax)

0

0

0

0

Exceptionals

0

0

0

0

Profit Before Tax (norm)

 

 

(42,482)

(71,138)

(69,936)

(16,123)

Profit Before Tax (reported)

 

 

(41,617)

(74,247)

(74,462)

(20,649)

Reported tax

3,569

4,605

4,618

1,281

Profit After Tax (norm)

(38,124)

(66,726)

(65,598)

(15,123)

Profit After Tax (reported)

(38,048)

(69,642)

(69,844)

(19,368)

Minority interests

0

0

0

0

Discontinued operations

0

0

0

0

Net income (normalised)

(38,124)

(66,726)

(65,598)

(15,123)

Net income (reported)

(38,048)

(69,642)

(69,844)

(19,368)

Average Number of Shares Outstanding (m)

157

170

192

201

EPS - normalised (DKK)

 

 

(0.24)

(0.39)

(0.34)

(0.08)

EPS - diluted normalised (DKK)

 

 

(0.24)

(0.39)

(0.34)

(0.08)

EPS - basic reported (DKK)

 

 

(0.24)

(0.41)

(0.36)

(0.10)

Dividend (DKK)

0.00

0.00

0.00

0.00

BALANCE SHEET

Fixed Assets

 

 

3,563

8,218

15,590

14,258

Intangible Assets

1,374

4,799

12,332

11,000

Tangible Assets

1,437

1,710

1,446

1,446

Investments & other

752

1,709

1,812

1,812

Current Assets

 

 

62,638

34,464

36,533

29,453

Stocks

3,631

4,155

3,702

5,381

Debtors

8,036

5,695

3,271

12,608

Cash & cash equivalents

46,709

18,122

20,037

1,940

Other

4,262

6,492

9,523

9,523

Current Liabilities

 

 

(9,217)

(14,858)

(42,985)

(49,415)

Creditors

(4,451)

(3,237)

(3,783)

(10,213)

Tax and social security

(141)

(2,306)

(3,409)

(3,409)

Short term borrowings

0

0

(20,000)

(20,000)

Other

(4,625)

(9,315)

(15,793)

(15,793)

Long Term Liabilities

 

 

(787)

(2,502)

(10,977)

(10,977)

Long term borrowings

0

0

0

0

Other long-term liabilities

(787)

(2,502)

(10,977)

(10,977)

Net Assets

 

 

56,197

25,322

(1,839)

(16,681)

Minority interests

0

0

0

0

Shareholders' equity

 

 

56,197

25,322

(1,839)

(16,681)

CASH FLOW

Op Cash Flow before WC and tax

(42,103)

(68,333)

(65,514)

(14,221)

Working capital

(631)

4,453

10,112

(4,587)

Exceptional & other

(74)

159

961

100

Tax

4,799

3,557

1,817

1,281

Net operating cash flow

 

 

(38,009)

(60,164)

(52,624)

(17,427)

Capex

(1,483)

(1,106)

(670)

(670)

Acquisitions/disposals

0

0

0

0

Net interest

0

0

0

0

Equity financing

39,319

35,983

37,921

0

Dividends

0

0

0

0

Other

(198)

(3,332)

(2,709)

0

Net Cash Flow

(371)

(28,619)

(18,082)

(18,097)

Opening net debt/(cash)

 

 

(47,080)

(46,709)

(18,122)

(57)

FX

0

0

0

0

Other non-cash movements

0

32

17

0

Closing net debt/(cash)

 

 

(46,709)

(18,122)

(57)

18,040

Source: BioPorto reports, Edison Investment Research


General disclaimer and copyright

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

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New Zealand

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United Kingdom

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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

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 BioPorto Diagnostics and prepared and issued by Edison, in consideration of a fee payable by BioPorto Diagnostics. 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

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

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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Sunesis Pharmaceuticals — A shift of gears

Sunesis’s task in realigning the company towards its new lead asset SNS-510 is twofold. First, it is examining the precise direction it intends to take the drug, and it has found synergies both with certain genetic subtypes of cancer as well as with other cancer drugs. Secondly, the company is both raising capital and reducing costs in order to provide the drug a runway into the clinic, and it estimates that it has cash through most of 2021.

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