Preparing for DNV3837 Phase II trial start

Deinove 25 April 2019 Update
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Deinove

Preparing for DNV3837 Phase II trial start

Company update

Pharma & biotech

25 April 2019

Price

€1.23

Market cap

€19m

Net cash (€m) at end-2018 (excludes non-conditional government loans of €11.0m)

3.9

Shares in issue

15.6m

Free float

83%

Code

ALDEI

Primary exchange

Euronext Growth

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(24.1)

(24.3)

(66.7)

Rel (local)

(28.3)

(33.4)

(67.2)

52-week high/low

€3.75

€1.20

Business description

Deinove is a biotechnology company that discovers, develops and produces high value-added compounds using its state-of-the-art bacterial strain selection, banking, fermentation and screening facilities. The most valuable compounds in the pipeline are novel antimicrobials, with lead asset DNV3837 ready for Phase II trial. Products for other applications, such as cosmetics and nutrition, will support drug development efforts.

Next events

Start of Phase II trial with DNV3837

2019

Cosmetics ingredient commercialisation updates

H119

2019 half-year financial results

26 September

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Alice Nettleton

+44 (0)20 3077 5700

Deinove is a research client of Edison Investment Research Limited

With its latest H218 report, Deinove reiterated its focus on the major areas of bioactives and antibiotics. The most recent significant announcement was its collaboration with the Institut Pasteur, which will provide access to a selection of bacterial strains. The upcoming initiation of the company’s first Phase II trial with DNV3837 for C. diff infections is the key milestone this year. According to the released details, the trial is expected to start in mid-2019 in the US and Germany, enrol 40 patients and last for about a year. If positive, the next step would likely be a Phase III trial. Deinove’s commercial activities will continue to focus on the two marketed and several other cosmetics ingredients in development. Our valuation is virtually unchanged at €66m or €4.2/share.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/17

0.2

(9.7)

(0.7)

0.0

N/A

N/A

12/18

0.8

(10.5)

(0.6)

0.0

N/A

N/A

12/19e

1.1

(13.2)

(0.7)

0.0

N/A

N/A

12/20e

2.9

(12.4)

(0.6)

0.0

N/A

N/A

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

Newsflow from antibiotics and AGIR programme

Deinove recently announced an agreement with the Institut Pasteur, one of the key global players in infectious disease research, which will provide access to a selection of bacterial strains. Using its platform technology, Deinove will be able to evaluate the antibiotic and antifungal activity potential. The company established similar collaborations with Naicons and bioMérieux in 2018 (described in our recent outlook report). Such agreements boost Deinove’s Antibiotics against Resistant Infectious aGents (AGIR) programme, which is supported by the Future Programme (run by Bpifrance) and should receive €14.6m over five years. The first €1.5m was received in Q119.

Bioactives portfolio development on track

The AGIR programme and the in-licensed DNV3837 are the major focus areas in antibiotics R&D pipeline (Exhibit 1). In its latest update on its bioactive ingredient portfolio, Deinove reiterated its focus on commercialising the two launched ingredients with more planned for launch in 2019 (as previously discussed in our outlook report). The internally developed PHYT-N-RESIST has been distributed by Univar and Solvay in all major geographies since 2018, while Hebelys has been developed and is marketed in partnership with Greentech.

Valuation: €66m or €4.2/share

We value Deinove at €66m (vs €65m) or €4.2/share (vs €4.2/share), using a 12.5% discount rate. From the antibiotics pipeline, we include only the lead asset DNV3837 in our valuation at €2.3/share, but will revisit other compounds as they progress through the preclinical stage. Other products in our valuation are the marketed cosmetics ingredients, Phyt-N-Resist and Hebelys, and the disclosed ingredients in development (Oléos, second carotenoid and nutrition).

Progress with bioactives and antibiotics

Deinove is a biotech company that develops innovative compounds from rare bacteria strains, including the little-explored Deinococcus genus. Using proprietary strain-selection technology and via collaborations with other institutions, the company has access to an extensive library of bacterial strains with various potential applications, including antibiotics, antifungals and other bioactive compounds (it also has programmes in cosmetics and animal nutrition). Of the many potential compounds identified by Deinove, the most valuable are novel antimicrobials.

An upcoming milestone event in antibiotic development will be the initiation of the Phase II trial with DNV3837, a novel quinolonyl-oxazolidinone class molecule, for C. diff infection. The recently released details indicate the trial is expected to start in mid-2019 in the US (10 centres) and Germany (five centres) and will enrol around 40 patients in severe and moderate cohorts. The study should last for about 10–12 months. If positive, the next step would likely be a registration Phase III trial. Deinove chose Medpace as a CRO for the trial. Detailed study protocol has not been released yet.

Exhibit 1: Deinove’s R&D pipeline and product portfolio

Source: Deinove

Financials and valuation

Because of the merger with Biovertis (including subsidiary Morphochem) in June 2018, the y-o-y comparison of the financial results is not meaningful. In 2018, Deinove reported operating revenue of €759k (€214k in 2017), of which €678k came from the AGIR programme (effectively government loans). Total operating costs amounted to €11.2m, of which €8.5m was R&D related. These were up from €7.4m and €2.5m in 2017 due to more intensive R&D. We maintain our revenue forecasts for FY19 and FY20, which are €1.12m and €2.94m respectively, and mainly reflect grant payments and expected initial sales of cosmetics products.

Existing cash (€3.9m at end-2018), the incoming grant stream and extended equity lines are sufficient to fund existing operations until 2020 and to initiate the Phase II trial with DNV3837. We expect the next fund-raise will focus significantly on supporting the DNV3837 asset to reach the Phase II readout, which represents an opportunity for value inflection. At the end of 2018, Deinove had €11.7m booked as long-term debt. Of that amount, €11.0m is non-conditional government loans, which are repayable if the products achieve commercial success.

Our risk-adjusted NPV is virtually unchanged at €66m or €4.2/share. We have rolled our model forward, which is partially offset by the higher net debt position (€7.8m vs €3.7m before). We maintain our all other assumptions for the R&D projects, as described in our outlook report.

We note that as of end-2018 there were unexercised share warrants and options amounting to c 10.9m; however, absolute majority (8.0m) of those were related to the acquisition of Biovertis/Morphochem. The warrants associated with the latter become exercisable only after certain milestones are met, which are related to clinical development. Each of these milestones is related to positive R&D developments, which typically provides catalysts for the share price.

Exhibit 2: DCF valuation of Deinove (operations including ingredients)

(€m)

2019e

2020e

2021e

2022e

2023e

2024e

2025e

2026e

2027e

2028e

2029e

2030e

EBIT (risk-adjusted)

(10.6)

(9.8)

(6.1)

(0.1)

3.2

6.1

7.9

8.6

9.8

10.5

11.2

12.0

Tax

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

D&A

2.0

1.9

1.1

1.1

1.1

1.1

1.1

1.1

0.6

0.6

0.6

0.6

Change in WC

4.1

0.0

0.5

(2.2)

(1.2)

(2.2)

0.0

(0.1)

0.5

0.5

1.1

0.5

Capex

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

(0.6)

Operating FCF

(5.1)

(8.5)

(5.1)

(1.8)

2.5

4.4

8.4

9.0

10.2

11.0

12.3

12.5

rNPV (€m)

Free cash flows FY19–30e

8.4

Terminal value (1.5% growth rate assumed)

29.2

Total value

37.6

Valuation/share (€)

2.4

Sum-of-the-parts Deinove valuation (operations including ingredients and antibiotic)

Product

Launch

Peak sales
(€m)

Unrisked NPV (€m)

Unrisked NPV/share (€)

Probability (%)

rNPV
(€m)

Value per share
(€)

Antibiotics (C. diff)

2025

209

125.9

8.1

27.5%

35.9

2.3

Bioactives (DCF)

37.6

2.4

Net debt at end-2018

(7.8)

(0.5)

Valuation

65.8

4.2

Source: Edison Investment Research. Note: Discount rate 12.5%. DCF taxes are offset by tax loss carryfoward (€54.4m in 2017)


Exhibit 3: Financial summary

€'000s

2016

2017

2018

2019e

2020e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

793

214

759

1,120

2,941

Cost of sales

0

0

0

(150)

(1,000)

Gross profit

793

214

759

970

1,941

EBITDA

 

 

(6,362)

(8,521)

(9,366)

(11,755)

(11,010)

Operating profit (before amort. and except.)

(7,676)

(9,681)

(10,496)

(13,155)

(12,373)

Intangible Amortisation

0

(376)

(430)

(562)

(511)

Exceptionals

639

296

172

0

0

Other

0

0

0

0

0

Operating profit

(7,037)

(9,761)

(10,754)

(13,716)

(12,884)

Net Interest

(31)

(5)

(6)

0

0

Profit Before Tax (norm)

 

 

(7,707)

(9,686)

(10,502)

(13,155)

(12,373)

Profit before tax (FRS 3)

 

 

(7,068)

(9,766)

(10,760)

(13,716)

(12,884)

Tax

1,115

2,430

2,014

2,576

2,612

Profit after tax (norm.)*

(6,897)

(7,256)

(8,488)

(10,579)

(9,761)

Profit after tax (FRS 3)*

(6,258)

(7,336)

(8,746)

(11,141)

(10,272)

Average Number of Shares Outstanding (m)

8.6

10.7

13.9

15.5

15.5

EPS - normalised (€)

 

 

(0.73)

(0.68)

(0.61)

(0.68)

(0.63)

EPS - (IFRS) (€)

 

 

(0.73)

(0.68)

(0.63)

(0.72)

(0.66)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

Gross margin (%)

N/A

N/A

N/A

N/A

N/A

EBITDA margin (%)

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed assets

 

 

2,336

5,741

6,923

5,174

3,899

Intangible assets

201

3,604

4,430

3,714

3,203

Tangible assets

1,851

2,044

2,397

1,363

600

Investments

284

93

96

96

96

Current assets

 

 

11,525

8,400

9,696

2,729

2,274

Stocks

0

0

0

0

0

Debtors

1,792

3,050

5,212

1,800

1,800

Cash

9,316

4,876

3,902

455

0

Other

417

474

582

474

474

Current liabilities

 

 

(2,141)

(2,663)

(2,876)

(3,360)

(11,632)

Creditors

(2,141)

(2,663)

(2,876)

(3,360)

(3,413)

Short-term borrowings

(0)

0

0

0

(8,219)

Long-term liabilities

 

 

(10,275)

(10,803)

(12,247)

(14,576)

(14,846)

Long-term borrowings

(9,178)

(9,972)

(11,677)

(14,006)

(14,276)

Other long-term liabilities

(1,097)

(831)

(570)

(570)

(570)

Net Assets

 

 

1,445

675

1,496

(10,033)

(20,305)

CASH FLOW

Operating cash flow

 

 

(6,327)

(9,346)

(11,383)

(7,902)

(10,973)

Net Interest

(31)

(5)

(6)

0

0

Tax

1,115

2,430

2,014

2,619

2,629

Capex

(519)

(1,208)

(1,410)

(600)

(600)

Acquisitions/disposals

28

551

0

0

0

Financing

437

2,345

8,106

108

0

Dividends

0

0

0

0

0

Net cash flow

(5,297)

(5,234)

(2,679)

(5,776)

(8,944)

Opening net debt/(cash)

 

 

(5,435)

(138)

5,096

7,775

13,551

HP finance leases initiated

0

0

0

0

0

Other

0

0

0

0

0

Closing net debt/(cash)

 

 

(138)

5,096

7,775

13,551

22,495

Closing net debt/(cash) (Excluding government loans)

(9,316)

(4,876)

(3,902)

(455)

0

Source: Deinove accounts, Edison Investment Research

General disclaimer and copyright

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

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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 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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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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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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 (nor will such persons be able to purchase shares in the placing).

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.

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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 Deinove and prepared and issued by Edison, in consideration of a fee payable by Deinove. 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 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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 Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). 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

Neither this document and associated email (together, the "Communication") constitutes or form part of any offer for sale or subscription of, or solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it form the basis of, or be relied on in connection with, any contract or commitment whatsoever. Any decision to purchase shares in the Company in the proposed placing should be made solely on the basis of the information to be contained in the admission document to be published in connection therewith.

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 (nor will such persons be able to purchase shares in the placing).

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

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. 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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