NeuroVive Pharmaceutical — Capital markets day take aways

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Research: Healthcare

NeuroVive Pharmaceutical — Capital markets day take aways

On 9 October 2019, NeuroVive held its capital markets day. Management presented its strategic focus on the company’s primary mitochondrial disease programmes, high unmet medical need in this area and advantages of the orphan drug development compared to drugs for common diseases. As expected, no major new details were disclosed. We note an interesting presentation on regulatory perspectives on orphan drug development by NeuroVive’s clinical and regulatory affairs director, Matilda Hugerth. It is not that often investors have straightforward access to expert knowledge about such a specialised topic presented in a clear format. Our valuation is unchanged at SEK1.63bn or SEK8.8/share.

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Healthcare

NeuroVive Pharmaceutical

Capital markets day take aways

Capital markets day

Pharma & biotech

23 October 2019

Price

SEK1.42

Market cap

SEK264m

Net cash (SEKm) at end Q219

99.1

Shares in issue

186.0m

Free float

95%

Code

NVP

Primary exchange

Nasdaq Stockholm

Secondary exchange

OTCQX

Share price performance

%

1m

3m

12m

Abs

(11.5)

13.8

(60.1)

Rel (local)

(13.2)

8.9

(65.0)

52-week high/low

SEK3.52

SEK1.16

Business description

NeuroVive Pharmaceutical is a Swedish biopharmaceutical company with deep expertise in mitochondrial medicine. It has a diversified portfolio in terms of indications and employs a dual strategy: it develops a core portfolio of assets for orphan diseases and seeks to out-license proprietary products for non-orphan indications. KL1333, NV354 (mitochondrial diseases) and NeuroSTAT (neurotrauma) are the most advanced assets.

Next events

Further interim results from Phase Ia/b with KL1333

H219

Q319 results

20 November 2019

Analyst

Jonas Peciulis

+44 (0)20 3077 5728

NeuroVive Pharmaceutical is a research client of Edison Investment Research Limited

On 9 October 2019, NeuroVive held its capital markets day. Management presented its strategic focus on the company's primary mitochondrial disease programmes, high unmet medical need in this area and advantages of the orphan drug development compared to drugs for common diseases. As expected, no major new details were disclosed. We note an interesting presentation on regulatory perspectives on orphan drug development by NeuroVive’s clinical and regulatory affairs director, Matilda Hugerth. It is not that often investors have straightforward access to expert knowledge about such a specialised topic presented in a clear format. Our valuation is unchanged at SEK1.63bn or SEK8.8/share.

Year end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/17

0.6

(70.1)

(1.49)

0.0

N/A

N/A

12/18

2.5

(68.8)

(0.94)

0.0

N/A

N/A

12/19e

1.5

(94.1)

(0.65)

0.0

N/A

N/A

12/20e

1.5

(117.9)

(0.66)

0.0

N/A

N/A

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

KL1333 and NV354 lead assets in core portfolio

KL1333, a small molecule NAD+ modulator used to restore intracellular energy balance, is in the multiple ascending dose (MAD) part of the Phase Ia/b trial. The single ascending dose (SAD) part of the trial delivered positive PK and safety data. KL1333 is being developed for primary mitochondrial disease, for example due to an m.3243 A>G mutation (eg MELAS, MIDD, PEO). The MAD part will also recruit mitochondrial disease patients (expected in H120). This will be the first time KL1333 is tested in patients and could potentially deliver interesting initial efficacy signs. If results are positive, the Phase II trial could start as soon as 2020. NV354, a succinate prodrug targeting complex I deficiency (such as Leigh syndrome and LHON), is the second lead drug candidate in the core portfolio targeting mitochondrial disease. The mechanism of action (MoA) is different to KL1333, but has the same goal of increasing the production of cellular energy (Exhibit 3). IND-enabling studies are ongoing and the Phase I study could start in 2020.

NeuroSTAT ready for Phase II development

NeuroSTAT, an innovative formulation of ciclosporin, is the most advanced asset in the portfolio for out-licensing and partnering and is positioned for the treatment of traumatic brain injury, where there is no neuroprotective treatment available yet. NeuroSTAT has accumulated some initial efficacy data and has received IND approval from the FDA. NeuroVive indicated that while promising, NeuroSTAT will require too much resource for NeuroVive to take to the market and hence it is focusing on finding partners that can finance the Phase II trial.

Valuation: SEK1.63bn or SEK8.8/share

We keep our valuation unchanged at SEK1.63bn or SEK8.8/sh. Potential near-term milestones include initial results from KL1333 Phase Ia/b, a non-dilutive financing solution for NeuroSTAT Phase II trial and NV354 entering clinical development. More detail on the projects are given in our recent update report.

Capital markets day take aways (exhibits)

Exhibit 1: NeuroVive’s R&D pipeline

Source: NeuroVive

Exhibit 2: KL1333 and NV354 projects

Source: NeuroVive

Exhibit 3: NeuroVive’s lead assets have different MoAs, but share the goal of increasing energy production

Source: NeuroVive

Exhibit 4: Orphan drug designation benefits

Direct benefits and incentives

Regulatory assistance – protocol assistance and scientific advice meetings

Financial regulatory incentives

Fee reductions, eg the EMA application fee of €278k waived for SMEs

Tax benefit, eg 50% of clinical costs in the US

National incentives, eg grants

Market exclusivity

EU: 10 years, plus two years if paediatric studies conducted

US: seven years

Additional effects of orphan designation

Lower clinical development costs (fewer patients need to be recruited)

Access to expedited programmes

Fast-track designation, breakthrough designation (US), PRIME (EU)

Conditional approval (EU), accelerated approval (US), accelerated review (EU), priority review (US)

Rare paediatric priority review voucher (US)

Historically likelihood of success is higher for orphan drugs (32% vs 11% for non-orphans)

Pricing and reimbursement: separate pool compared to non-orphans, premium price is more common

Source: NeuroVive

Exhibit 5: NeuroVive sum-of-the parts valuation

Product

Launch

Peak sales*
($m)

NPV
($m)

NPV/share
($)

Probability

rNPV
($m)

rNPV/share
($)

KL1333

2024

574

626.7

3.4

10%

58.8

0.3

NV354**

2027

875

480.6

2.6

5%

21.4

0.1

NeuroSTAT

2025

454

306.0

1.6

15%

37.0

0.2

NV556

2027

1,743

147.8

0.8

8%

32.2

0.2

NVP024

2029

730

33.0

0.2

3%

7.9

0.0

Net cash, last reported

10.2

0.1

100%

10.5

0.1

Valuation

 

 

1,604.2

8.6

167.5

0.9

SEKm

SEK/share

Probability

SEKm

SEK/share

KL1333

6,103.7

32.8

10%

573.1

3.1

NV354

4,680.6

25.2

5%

208.5

1.1

NeuroSTAT

2,980.2

16.0

15%

360.5

1.9

NV556

1,439.8

7.7

8%

313.5

1.7

NVP024

321.1

1.7

3%

77.0

0.4

Net cash, last reported

99.1

0.5

100%

99.1

0.5

Valuation

15,624.5

84.0

1,631.7

8.8

Source: Edison Investment Research. Note: *Peak sales reached six years after launch. WACC = 12.5% for product valuations. **Formerly NVP015.

Exhibit 6: Financial summary

SEK'000s

 

2017

2018

2019e

2020e

December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

585

2,466

1,500

1,500

Cost of Sales

0

0

0

0

Gross Profit

585

2,466

1,500

1,500

Research and development

(27,926)

(37,922)

(61,687)

(83,764)

EBITDA

 

 

(67,897)

(66,675)

(94,001)

(117,791)

Operating Profit (before amort. and except.)

 

 

(69,492)

(68,589)

(94,148)

(117,923)

Intangible Amortisation

0

0

0

0

Exceptionals

(1,595)

(4,771)

0

0

Other

56

66

0

0

Operating Profit

(71,031)

(73,294)

(94,148)

(117,923)

Net Interest

(571)

(200)

0

0

Profit Before Tax (norm)

 

 

(70,063)

(68,789)

(94,148)

(117,923)

Profit Before Tax (reported)

 

 

(71,602)

(73,494)

(94,148)

(117,923)

Tax

0

0

0

0

Profit After Tax (norm)

(70,007)

(68,723)

(94,148)

(117,923)

Profit After Tax (reported)

(66,727)

(68,373)

(89,027)

(112,802)

Average Number of Shares Outstanding (m)

50.2

78.5

152.8

186.0

EPS - normalised (SEK)

 

 

(1.49)

(0.94)

(0.65)

(0.66)

EPS - normalised fully diluted (SEK)

 

 

(1.49)

(0.94)

(0.65)

(0.66)

EPS - reported (SEK)

 

 

(1.33)

(0.87)

(0.58)

(0.61)

Dividend per share (SEK)

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

100.0

100.0

100.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

87,579

86,681

86,681

86,681

Intangible Assets

74,315

73,440

73,440

73,440

Tangible Assets

162

140

140

140

Investments

13,102

13,101

13,101

13,101

Current Assets

 

 

30,560

27,383

41,385

1,432

Stocks

0

0

0

0

Debtors

0

0

0

0

Cash

28,992

25,951

39,953

0

Other

1,568

1,432

1,432

1,432

Current Liabilities

 

 

(14,259)

(18,296)

(18,296)

(18,296)

Creditors

(14,259)

(18,296)

(18,296)

(18,296)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

0

0

0

(77,908)

Long term borrowings

0

0

0

(77,908)

Other long term liabilities

0

0

0

0

Net Assets

 

 

103,880

95,768

109,770

(8,091)

CASH FLOW

Operating Cash Flow

 

 

(58,039)

(63,630)

(94,001)

(117,791)

Net Interest

(84)

(199)

0

0

Tax

0

0

0

0

Capex

(40)

(82)

(87)

(70)

Acquisitions/disposals*

(11,035)

0

0

0

Financing

9,031

64,656

108,090

0

Other

(4,092)

(3,786)

0

0

Dividends

0

0

0

0

Net Cash Flow

(64,259)

(3,041)

14,002

(117,861)

Opening net debt/(cash)

 

 

(93,251)

(28,992)

(25,951)

(39,953)

HP finance leases initiated

0

0

0

0

Other

0

(0)

0

0

Closing net debt/(cash)

 

 

(28,992)

(25,951)

(39,953)

77,908

Source: NeuroVive accounts, Edison Investment Research


General disclaimer and copyright

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

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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

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London +44 (0)20 3077 5700

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United Kingdom

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1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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Level 4, Office 1205

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General disclaimer and copyright

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

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

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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