Interim AM-201 data

Auris Medical Holding 15 October 2019 Update
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Auris Medical Holding

Interim AM-201 data

Development update

Pharma & biotech

15 October 2019

Price

US$2.02

Market cap

US$7m

US$1/CHF

Net cash ($m) at 30 June 2019

5.79

Shares in issue

3.3m

Free float

81.3%

Code

EARS

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(33.1)

(24.9)

(89.7)

Rel (local)

(32.2)

(23.7)

(90.4)

52-week high/low

US$29.6

US$2.0

Business description

Auris Medical is a Swiss biopharmaceutical company developing neurotology and central nervous system targeting therapeutics. It is developing intranasal betahistine in a Phase I trial for mental disorder supportive care and it is entering Phase II for vertigo; both are designed to demonstrate proof-of-concept.

Next events

AM-125 Phase IIa interim readout

Q419/Q120

AM-201 Phase Ib 30mg dose readout

Q120

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Auris Medical Holding is a research client of Edison Investment Research Limited

Auris has announced interim data from its 50-subject AM-201 Phase Ib trial for olanzapine-induced weight gain and somnolence. The drug demonstrated safety and tolerability and provided initial signals of efficacy (limitations of the trial in terms of size and duration hamper its ability to provide definitive evidence). In the female study subjects, who showed more pronounced changes than the male study subjects, AM-201 demonstrated a 1.1kg benefit versus placebo over four weeks in those who received the highest dose (20mg three times daily). The company is now proceeding to a final dose level of 30mg in 30 healthy volunteers, with data expected around the end of Q120.

Year end

Revenue (CHFm)

PBT*
(CHFm)

EPS*
(CHF)

DPS
(CHF)

P/E
(x)

Yield
(%)

12/17

0.0

(25.9)

(10.72)

0.0

N/A

N/A

12/18

0.0

(12.0)

(15.33)

0.0

N/A

N/A

12/19e

0.0

(11.0)

(3.78)

0.0

N/A

N/A

12/20e

0.0

(18.8)

(4.26)

0.0

N/A

N/A

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

AM-201 trial continuing to the 30mg dose level

Auris is developing AM-201, intranasal betahistine, for co-administration with olanzapine to counteract adverse effects such as weight gain and sleepiness. There were initial efficacy signals seen and the company is continuing the trial on to 30mg in 30 patients to help confirm the finding.

TRAVERS trial data in 138 patients coming soon

Auris is developing AM-125, also an intranasal formulation of betahistine, for the treatment of acute vertigo. The Phase II trial, TRAVERS, will include 138 patients with surgically induced acute vertigo following vestibular schwannoma excision. The trial has started enrolling with interim data expected in Q419/Q120.

Regulatory feedback for the tinnitus program

The company announced in September that it received positive regulatory feedback from the FDA and EMA on the design of a new Phase II/III trial of Keyzilen/AM-101 for acute inner ear tinnitus. The company and agencies are aligned on key aspects of the design (such as using the Tinnitus Functional Index (TFI) questionnaire as the primary outcome measure). Auris is currently exploring non-dilutive funding options to fund development.

Valuation: $132.5m or $32.59 per basic share

We are maintaining our valuation of $132.5m or $32.59 per basic share ($20.69 per diluted share). Key upcoming catalysts that may change our valuation for Auris will be the TRAVERS data in Q419/Q120 as well as the 30mg dose level data from the AM-201 proof-of-concept trial. As of the end of H119, Auris had CHF5.8m in cash and equivalents. In our forecasts, we model a total of CHF65m in financing needs through 2023, which we record as illustrative debt.

Initial signals of efficacy

Auris announced interim data from its 50-subject AM-201 Phase Ib proof-of-concept trial (across five dose cohorts to date) of intranasal betahistine for olanzapine-induced weight gain and somnolence. According to the company, AM-201 demonstrated safety and tolerability and also showed some initial signs of efficacy. In the female study subjects, who showed more pronounced changes than the male study subjects, AM-201 demonstrated a 1.1kg benefit versus placebo over four weeks at the highest dose (20mg three times daily). There are of course some important caveats with the main one being that this benefit was seen in a subset of only five patients as there were 10 patients in each dose cohort and they were equally split between male and female. The study will now advance to the next higher and final dose level of 30mg three times daily cohort will include 30 patients so that should help provide comfort with the initial signals. Data is expected around the end of Q120 (we hope at that point to also see some data on the impact on somnolence, as the company indicated a benefit but did not release any specific data on it).

There is also the question of whether 1.1kg is a clinically meaningful benefit. It is far too early to tell as we do not have the full data set including baseline weight and how much of the olanzapine weight gain was offset. Also, as AM-201 is not a weight-loss drug but a drug that offsets the weight gain effect of other drugs, there must be weight gain in the control arm in order for it to show a benefit. Based on historical data (see Exhibit 1), it typically takes time for significant weight gain to develop in patients treated with olanzapine and this was only a four-week trial. Hence, there will not be any definitive answer on efficacy prior to longer-term clinical trials.

Exhibit 1: Schizophrenic patients demonstrating more than 7% body weight gain on SGAs

Drug

Percent of patients experiencing weight gain at 12 weeks (%)

Percent of patients experiencing weight gain at 52 weeks (%)

Olanzapine

59.8

80.0

Risperidone

32.5

57.6

Quetiapine

29.2

50.0

Source: Adapted from Patel, J. K., et al. (2009). Metabolic profiles of second-generation antipsychotics in early psychosis: Findings from the CAFE study. Schizophrenia Research,111(1-3), 9-16.

Feedback on the Keyzilen (AM-101) development plan

Auris announced in September that it received positive regulatory feedback from the FDA and EMA on the design of a new Phase II/III trial of Keyzilen/AM-101 for acute inner ear tinnitus. The company and agencies are aligned on key aspects of the design, including the use of the Tinnitus Functional Index (TFI) questionnaire as the primary outcome measure. Another point of agreement includes less frequent collection of patient-reported tinnitus loudness as daily reporting had been an issue in previous trials. The FDA will consider improvement in tinnitus loudness as a co-primary efficacy endpoint, while the EMA will view it as a secondary endpoint. We expect additional details on the design of the new Phase II/III trial in the coming months though that may depend on the source of the funding for the program. The company is currently exploring non-dilutive funding options for the program including partnering, special purpose vehicle financing, grants or a combination of the three. Note that we currently include no value in our model for this potentially late-stage program due to previously missed Phase III trial endpoints, but that may change once a viable path forward is determined.


Valuation

We are maintaining our valuation of $132.5m or $32.59 per basic share ($20.69 per diluted share). Key upcoming catalysts that may change our valuation for Auris will be the TRAVERS data in Q419/Q120 as well as the 30mg dose level data from the AM-201 proof-of-concept trial around the end of Q120.

Exhibit 2: Auris Medical valuation table

Program

Market

Indication

Clinical stage

Probability of success

Launch year

Peak sales ($m)

rNPV ($m)

AM-125

US

Acute vertigo

Phase I

30%

2023

88.73

$25.2

AM-125

Europe

Acute vertigo

Phase I

45%

2022

113.12

$62.8

AM-201

US

Mental health supportive care

Phase I

20%

2024

128.72

$16.4

AM-201

Europe

Mental health supportive care

Phase I

20%

2025

143.85

$22.4

Total

126.73

Net cash and equivalents (As of 30 June 2019) ($m)

5.79

Total firm value ($m)

132.52

Total basic shares (including pre-funded warrants, m)

4.1

Value per basic share ($)

32.59

Options and warrants (m)

2.3

Total diluted shares (m)

6.4

Value per diluted share ($)

20.69

Source: Auris Medical reports, Edison Investment Research

Financials

As of the end of H119, Auris had CHF5.8m in cash and equivalents. The company had reiterated at the H119 results prior guidance for operating expenditure in the range of CHF10m to CHF13m for FY19. In our forecasts, we model a total of CHF65m in financing needs through 2023, which we record as illustrative debt.

Exhibit 3: Financial summary

CHF000s

2017

2018

2019e

2020e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

 

0

0

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

0

0

0

Research and development

(19,211)

(6,690)

(5,204)

(12,000)

Selling, general & administrative

(5,150)

(4,265)

(5,719)

(5,833)

EBITDA

 

 

 

(24,484)

(11,027)

(10,951)

(17,889)

Operating Profit (before amort. and except.)

 

 

 

(24,361)

(10,954)

(10,923)

(17,861)

Intangible Amortisation

0

0

0

0

Exceptionals/Other

0

0

0

0

Operating Profit

(24,361)

(10,954)

(10,923)

(17,861)

Net Interest

(1,586)

(1,070)

(51)

(900)

Other (change in fair value of warrants)

1,520

690

267

0

Profit Before Tax (norm)

 

 

 

(25,947)

(12,024)

(10,973)

(18,761)

Profit Before Tax (IFRS)

 

 

 

(24,427)

(11,334)

(10,706)

(18,761)

Tax

18

(162)

261

0

Deferred tax

322

1,266

261

0

Profit After Tax (norm)

(25,929)

(12,186)

(10,712)

(18,761)

Profit After Tax (IFRS)

(24,087)

(10,230)

(10,184)

(18,761)

Average Number of Shares Outstanding (m)

2.4

0.8

2.8

4.4

EPS - normalised (CHF)

 

 

 

(10.72)

(15.33)

(3.78)

(4.26)

EPS - IFRS (CHF)

 

 

 

(9.96)

(12.87)

(3.59)

(4.26)

Dividend per share (CHF)

0.0

0.0

0.0

0.0

Gross Margin (%)

N/A

N/A

N/A

N/A

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

 

 

 

1,959

3,812

5,416

5,388

Intangible Assets

1,629

3,535

5,158

5,130

Tangible Assets

253

34

20

20

Other

77

243

238

238

Current Assets

 

 

 

15,868

6,065

4,491

5,352

Stocks

0

0

0

0

Debtors

241

320

301

301

Cash

14,973

5,393

3,965

4,826

Other

653

351

224

224

Current Liabilities

 

 

 

(10,426)

(4,563)

(1,783)

(3,877)

Creditors

(5,884)

(3,127)

(1,783)

(3,877)

Short term borrowings

(4,542)

(1,435)

0

0

Long Term Liabilities

 

 

 

(9,563)

(1,665)

(5,999)

(23,499)

Long term borrowings

(5,584)

0

(5,000)

(22,500)

Other long term liabilities

(3,979)

(1,665)

(999)

(999)

Net Assets

 

 

 

(2,162)

3,649

2,125

(16,636)

CASH FLOW

Operating Cash Flow

 

 

 

(25,827)

(14,447)

(12,100)

(16,639)

Net Interest

1,569

1,053

19

0

Tax

(18)

162

0

0

Capex

(153)

(1,891)

(1,620)

0

Acquisitions/disposals

0

68

0

0

Financing

10,308

15,005

8,701

0

Dividends

0

0

0

0

Other

(2,034)

0

0

0

Net Cash Flow

(16,154)

(50)

(5,000)

(16,639)

Opening net debt/(cash)

 

 

 

(20,078)

(4,847)

(3,958)

1,079

HP finance leases initiated

0

0

0

0

Exchange rate movements

1,316

258

(36)

0

Other

(393)

(1,097)

0

0

Closing net debt/(cash)

 

 

 

(4,847)

(3,958)

1,079

17,717

Source: Auris Medical reports, Edison Investment Research


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

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Frankfurt +49 (0)69 78 8076 960

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Germany

London +44 (0)20 3077 5700

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London, WC1V 7EE

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New York +1 646 653 7026

1,185 Avenue of the Americas

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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 Auris Medical Holding and prepared and issued by Edison, in consideration of a fee payable by Auris Medical Holding. 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.

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

New Zealand

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

United Kingdom

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

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

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

United States

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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