Newron Pharmaceuticals — Crucial upcoming datasets for evenamide

Newron Pharmaceuticals (SIX: NWRN)

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Research: Healthcare

Newron Pharmaceuticals — Crucial upcoming datasets for evenamide

Newron has released its H123 results and presented an overview of its upcoming clinical activities assessing evenamide as a potential treatment for schizophrenia. Positive results from these trials from Q423 to Q124, may represent the most significant near-term catalysts for the company, in our view. Throughout the period, Newron has also continued to work with partners Zambon and Supernus to maintain the intellectual property of Xadago in the US, which is protected by three patents until at least 2027. At end-June 2023, Newron had a total cash and liquid asset position of €17.1m (versus €22.8m at the start of the year), which we estimate will provide a cash runway into 2024. We value Newron at CHF137.4m or CHF7.7 per share (previously CHF128.7m or CHF7.2 per share).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Newron Pharmaceuticals

Crucial upcoming datasets for evenamide

H123 results update

Pharma and biotech

7 August 2023

Price

CHF5.38

Market cap

CHF96m

€1.02/CHF

Net debt (€m) at end-June 2023

29.5

Shares in issue

17.8m

Free float

99%

Code

NWRN

Primary exchange

SIX Swiss Exchange

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(6.6)

16.2

289.9

Rel (local)

(5.6)

19.9

293.5

52-week high/low

CHF8.0

CHF1.1

Business description

Newron Pharmaceuticals is focused on the central nervous system. Xadago for Parkinson’s disease is sold in Europe, Japan and the United States. Evenamide, a novel schizophrenia add-on therapy, is involved in a Phase III trial programme targeting schizophrenia.

Next events

Evenamide study 003 initiation

H223

Evenamide study 015 read-outs

Q124

Evenamide study 008A read-outs

Q124

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

Newron Pharmaceuticals is a research client of Edison Investment Research Limited

Newron has released its H123 results and presented an overview of its upcoming clinical activities assessing evenamide as a potential treatment for schizophrenia. Positive results from these trials from Q423 to Q124, may represent the most significant near-term catalysts for the company, in our view. Throughout the period, Newron has also continued to work with partners Zambon and Supernus to maintain the intellectual property of Xadago in the US, which is protected by three patents until at least 2027. At end-June 2023, Newron had a total cash and liquid asset position of €17.1m (versus €22.8m at the start of the year), which we estimate will provide a cash runway into 2024. We value Newron at CHF137.4m or CHF7.7 per share (previously CHF128.7m or CHF7.2 per share).

Year end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/21

5.76

(14.12)

(0.79)

0.0

N/A

N/A

12/22

6.09

(16.99)

(0.95)

0.0

N/A

N/A

12/23e

8.95

(14.62)

(0.82)

0.0

N/A

N/A

12/24e

6.85

(22.27)

(1.25)

0.0

N/A

N/A

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

Study 014/015: Full one-year results expected in Q124

The Phase II trial (study 014 – six weeks, and study 015 – extension study) is a randomised, open-label, rater-blinded assessment of evenamide (safety and efficacy) as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS). The most recent update from extension study 015 provided data for the first 100 patients at the one-year timepoint, and demonstrated the efficacy of evenamide across multiple measures of psychopathology. Six-month results from the full 161-patient cohort in study 015 are expected in October 2023, and full one-year data are expected in Q124. We note that interim results have been encouraging, and hence Newron is preparing to initiate a potentially pivotal Phase III trial (study 003). This will be a randomised, double-blind, placebo-controlled study to assess the potential of evenamide as an add-on treatment in TRS patients, expected to launch in H223.

Study 008A: Results expected by end-2023 or Q124

The Phase III trial (study 008A) is a potentially pivotal randomised, double-blind, placebo-controlled study to assess the safety, efficacy and tolerability of evenamide in patients on antipsychotics, but not classified as having TRS. Management has communicated that patient recruitment is ongoing, and the company is on track to share full results by end-2023 or Q124, potentially representing a major catalyst.

Valuation: CHF137.4m or CHF7.7 per share

Our valuation for Newron increases to CHF137.4m or CHF7.7 per share (previously CHF128.7m or CHF7.2 per share) due to rolling forward our model by six months and FX changes, partially offset by increased net debt at end H123.

Financials

In its H123 results, Newron recorded total revenue of €5.5m for the period, nearly double H122 revenue of €2.8m. The revenue increase was primarily driven by higher royalty income of €3.2m (versus €2.8m in H122) for Xadago and an additional €2.3m in other income related to contracts with customers (H122: zero). Total operating expenses were up by 5.6% y-o-y to €9.8m in H123, out of which R&D expenses moderately increased to €5.7m (H122: €5.3m) due to increased services from subcontractors as a result of ongoing clinical activities. G&A expenses were €4.1m, compared to €3.9m in H122. As a result, the operating loss for the period was €4.3m, versus €6.5m in H122. The company reported a pre-tax loss of €6.9m (H122: €8.6m), which included €2.0m in interest expenses mainly relating to the European Investment Bank loan. Cash used in operating activities for H123 remained largely flat at €5.6m.

Based on the H123 results, we have increased our FY23 revenue forecast to €8.9m (vs €6.5m previously) as we now incorporate other income of €2.5m based on the half year performance. This adjusts our operating loss and net loss forecasts to €11.9m (€14.4m previously) and €14.6m (€17.1m previously), respectively in FY23. Our long-term assumptions and FY24 forecasts remain unchanged based on H123 performance.

At end-H123, Newron had a cash position of €7.7m, plus €9.4m in other current financial and liquid assets. Based on our forecasted operating cash burn, we estimate a cash runway into 2024, consistent with management guidance. Assuming a positive readout from study 008A in H223, we expect Newron will pursue a partnership deal for evenamide in schizophrenia, a payment from which may extend our estimated cash runway further. In the absence of a partnership deal for evenamide in schizophrenia, we continue to expect that the company would need to raise additional capital of €30m in FY24, which we have modelled as illustrative debt. If the funding is realised through an equity issue instead (at the 3 August 2023 closing trading price of CHF5.00 per share), Newron would have to issue 6.0m shares, resulting in our per share valuation reducing to CHF7.0 per share from CHF7.7 currently (shares outstanding would increase from 17.9m to 23.8m).

Valuation: CHF137.4m or CHF7.7 per share

Our valuation for Newron increases to CHF137.4m or CHF7.7 per share (previously CHF128.7m or CHF7.2 per share). The increase in our valuation comes from rolling forward the model by six months and foreign exchange changes (€1.04/CHF, previously €1.02/CHF, and US$1.09/€, previously US$1.8/€), which was partially offset by increased net debt of CHF28.3m (€21.9m previously). Our valuation is based on a risk-adjusted net present value (NPV) calculation for Xadago in Parkinson’s disease and evenamide in schizophrenia (Exhibit 1).

Exhibit 1: Newron valuation breakdown

Product

Indication

Launch

Probability

rNPV (CHFm)

NPV/share (CHF/share)

Xadago

Parkinson's disease

2015

100%

34.0

1.9

Evenamide

Schizophrenia

2025

60%

252.2

14.1

Total direct product value

 

 

 

286.3

16.0

 

Direct costs to 2033 less tax

(120.5)

(6.8)

Cash at end-June 2023

16.5

0.9

Loans (fair value June 2023)

(44.8)

(2.5)

Valuation

 

 

 

137.4

7.7

Source: Edison Investment Research

Exhibit 2: Financial summary

Accounts: IFRS, Yr end: December 31, €:000s

 

 

2020

2021

2022

2023e

2024e

PROFIT & LOSS

 

 

 

 

 

 

 

Total revenues

 

 

5,258

5,762

6,094

8,947

6,847

Cost of sales

 

 

0

0

0

0

0

Gross profit

 

 

5,258

5,762

6,094

8,947

6,847

Total operating expenses

 

 

(23,324)

(18,119)

(19,396)

(20,881)

(26,043)

Research and development expenses

 

 

(14,853)

(10,725)

(12,005)

(13,434)

(18,521)

SG&A

 

 

(8,471)

(7,394)

(7,391)

(7,448)

(7,522)

EBITDA (normalized)

 

 

(16,386)

(11,386)

(12,620)

(11,747)

(19,078)

Operating income (reported)

 

 

(18,066)

(12,357)

(13,302)

(11,935)

(19,196)

Finance income/(expense)

 

 

(1,552)

(2,527)

(4,170)

(2,681)

(3,070)

Exceptionals and adjustments

 

 

0

0

0

0

0

Profit before tax (reported)

 

 

(19,618)

(14,884)

(17,472)

(14,615)

(22,266)

Profit before tax (normalised)

 

 

(18,157)

(14,122)

(16,992)

(14,615)

(22,266)

Income tax expense (includes exceptionals)

 

 

(1,380)

(17)

(21,000)

0

0

Net income (reported)

 

 

(20,998)

(14,901)

(17,493)

(14,615)

(22,266)

Net income (normalised)

 

 

(19,537)

(14,139)

(17,013)

(14,615)

(22,266)

Basic average number of shares, m

 

 

17,845.0

17,845.0

17,845.0

17,845.0

17,845.0

Basic EPS (€)

 

 

(1.18)

(0.84)

(0.98)

(0.82)

(1.25)

Adjusted EPS (€)

 

 

(1.09)

(0.79)

(0.95)

(0.82)

(1.25)

 

 

 

 

 

 

 

 

BALANCE SHEET

 

 

 

 

 

 

 

Property, Plant and Equipment

 

 

105

87

72

72

72

Right of use assets (leases)

 

 

629

490

455

285

186

Intangible Assets

 

 

11

2

0

0

0

Non-current receivables (Tax credits)

 

 

12,579

10,480

8,175

5,774

3,087

Total non-current assets

 

 

13,324

11,059

8,702

6,131

3,345

Cash and equivalents

 

 

13,213

25,019

13,424

10,908

4,313

Current financial assets

 

 

18,037

9,575

9,350

0

0

Inventories

 

 

0

0

0

0

0

Trade Accounts Receivable

 

 

6,624

4,833

5,719

5,276

5,498

Total current assets

 

 

37,874

39,427

28,493

16,184

9,810

Trade Accounts Payable

 

 

6,741

3,504

4,869

4,605

5,211

Other Current Liabilities

 

 

151

150

172

172

172

Total current liabilities

 

 

6,892

3,654

5,041

4,777

5,383

Long-term Debt

 

 

25,674

42,542

45,165

32,756

57,665

Leasing Obligations

 

 

520

389

325

325

325

Share based liabilities

 

 

181

213

220

220

220

Long-term Provisions

 

 

685

581

474

474

474

Total non-current liabilities

 

 

27,060

43,725

46,184

33,775

58,684

Equity attributable to company

 

 

17,246

3,107

(14,030)

(28,645)

(50,911)

 

 

 

 

 

 

 

 

CASH FLOW STATEMENT

 

 

Pre-tax profit

 

 

(19,618)

(14,884)

(17,472)

(14,615)

(22,266)

Net Financial Income

 

 

(531)

(792)

(1,183)

0

0

Depreciation and amortisation

 

 

219

209

202

188

118

Share based payments

 

 

1,461

762

480

0

0

Other adjustments

 

 

(842)

3,524

4,996

2,401

2,687

Movements in working capital

 

 

3,723

(264)

1,885

179

384

Cash from operations (CFO)

 

 

(15,588)

(11,445)

(11,092)

(11,848)

(19,077)

Capex

 

 

(34)

(20)

(18)

(18)

(18)

Acquisitions & disposals net

 

 

0

0

0

0

0

Other investing activities

 

 

(582)

8,440

(299)

9,350

0

Cash used in investing activities (CFIA)

 

 

(616)

8,420

(317)

9,332

(18)

Loans received

 

 

7,500

15,000

0

0

0

Illustrative debt

 

 

0

0

0

0

30,000

Loan repayments

 

 

0

0

0

0

0

Equity issued

 

 

0

0

0

0

0

Other Financing Cash Flows (leases)

 

 

(135)

(169)

(186)

0

0

Cash from financing activities (CFF)

 

 

7,365

14,831

(186)

0

30,000

Cash and equivalents at beginning of period

 

 

22,052

13,213

25,019

13,424

10,908

Increase/(decrease) in cash and equivalents

 

 

(8,839)

11,806

(11,595)

(2,516)

10,905

Effect of FX on cash and equivalents

 

 

0

0

0

0

0

Cash and equivalents at end of period

 

 

13,213

25,019

13,424

10,908

21,813

Net (debt)/cash (including liquid resources)

 

 

5,576

(7,948)

(22,391)

(21,848)

(35,852)

Source: Company Reports, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by Newron Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Newron Pharmaceuticals. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

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 2023 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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by Newron Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Newron Pharmaceuticals. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

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 2023 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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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