Auris Medical Holding — A nasal spray to help protect against COVID-19

Auris Medical Holding — A nasal spray to help protect against COVID-19

Auris recently announced the development of the AM-301 nasal spray for protection against SARS-COV-2 (COVID-19) infection (though it is also intended to protect against other airborne pathogens and allergens as well). AM-301 is a gel that would form a protective layer in the nasal mucosa, preventing contact between the pathogen and cells. In vitro data so far suggest contact between AM-301 and COVID-19 reduced the viral load by up to 99%. The company is targeting regulatory submission as an over the counter (OTC) product in 2021.

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Auris Medical Holding

A nasal spray to help protect against COVID-19

Development update

Pharma & biotech

18 September 2020

Price

US$0.82

Market cap

US$6m

US$0.91/CHF

Net debt ($m) as of 30 June 2020

0.01

Shares in issue

7.1m

Free float

59.2%

Code

EARS

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(24.9)

(20.4)

(72.8)

Rel (local)

(24.4)

(26.2)

(75.7)

52-week high/low

US$3.08

US$0.70

Business description

Auris Medical is a Swiss biopharmaceutical company developing neurotology and central nervous system targeting therapeutics. It is developing intranasal betahistine for mental disorder supportive care (recently completed Phase I) and it is in Phase II for vertigo. Additionally, it has begun development on AM-301 for the protection against airborne pathogens and allergens.

Next events

AM-125 Part B completion of enrolment

Q121

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 recently announced the development of the AM-301 nasal spray for protection against SARS-COV-2 (COVID-19) infection (though it is also intended to protect against other airborne pathogens and allergens as well). AM-301 is a gel that would form a protective layer in the nasal mucosa, preventing contact between the pathogen and cells. In vitro data so far suggest contact between AM-301 and COVID-19 reduced the viral load by up to 99%. The company is targeting regulatory submission as an over the counter (OTC) product in 2021.

Year end

Revenue (CHFm)

PBT*
(CHFm)

EPS*
(CHF)

DPS
(CHF)

P/E
(x)

Yield
(%)

12/18

0.0

(12.0)

(15.33)

0.0

N/A

N/A

12/19

0.0

(7.3)

(2.43)

0.0

N/A

N/A

12/20e**

0.0

(5.4)

(0.91)

0.0

N/A

N/A

12/21e**

0.0

(14.0)

(1.95)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortization of acquired intangibles, exceptional items and share-based payments. **Note that the company capitalizes a portion of R&D whereas our forecasts do not capitalize such expenses in FY21 and beyond, and hence reported R&D expenses will likely be lower than our forecasts.

Part A of Phase II TRAVERS trial interim analysis

Part A of the TRAVERS trial of AM-125 in patients with acute vertigo showed a dose dependent improvement in balance in patients (three dose levels were tested, 1mg, 10mg and 20mg three times daily). At the highest dose (20mg), patients receiving AM-125 were able to balance themselves for 6.0 seconds vs 3.1 seconds on placebo 14 days post-surgery. In a separate test where patients were asked to stand on foam, AM-125 patients stood for 10.5 seconds versus 4.3 seconds for those who received placebo. The changes were statistically significant vs baseline.

Part B of TRAVERS trial underway

Following the interim results from part A, the company has selected the two highest doses from part A (10mg and 20mg three times daily) for Part B, which will be testing those doses versus placebo in 72 patients. Improvement in the standing on foam test (2 weeks after surgery) will be the sole primary endpoint while the Tandem Romberg test (6 weeks after surgery) will be the key secondary endpoint.

AM-201 Phase Ib trial data at 30mg dose

At the 30mg dose of AM-201 for anti-psychotic induced weight gain, subjects receiving 30mg three times daily in the Phase Ib study showed a 24% reduction in weight gain following treatment with olanzapine at the 28 day time point (2.8kg gained for those taking AM-201 in addition to olanzapine vs 3.7kg weight gain for those only on olanzapine, p<0.02). The company is preparing for a Phase II trial.

Valuation: $127.1m or $17.93 per basic share

We are adjusting our valuation to $127.1m or $17.93 per basic share, from $121.1m or $27.47 per basic share. The total value increased as we rolled forward our NPV though this was partially offset by lower net cash. The per-share value fell due to a higher number of shares outstanding as the company raised capital.

H120 update highlights progress

Auris on 8 September 2020 announced a new product and therapeutic area. The company has started development of AM-301, a nasal spray for protection against SARS-COV-2 (COVID-19) infection, which is intended to also protect against other airborne pathogens and allergens. AM-301 is a gel that would form a thin protective layer in the nasal mucosa, preventing contact between the pathogen and cells. In addition, the composition is able to trap and bind the pathogens. In vitro data so far suggest contact between AM-301’s key component and COVID-19 reduced the viral load by up to 99% (depending on concentration) with testing of additional pathogens and allergens expected to begin in the coming months.

The company is looking to develop AM-301 as an OTC product, hence available to consumers without a prescription as the formulation would be drug-free. The target market will likely be those consumers who will seek short-term protection (likely a few hours per use) from infection while outside their homes at various venues (schools, movie theatres, restaurants, public transportation).

In order to fund this product, the company has set up a new subsidiary, Altamira Medical. So far CHF1.5m in convertible debt has been raised (in Q320) to fund Altamira and AM-301’s development. The debt has an 8% annual interest rate, an 18-month term and would be convertible into shares of either Altamira or Auris. Currently Auris owns 100% of Altamira but this is expected to decrease as additional investors come in as further financing for AM-301 is needed.

Auris also recently provided an update on its AM-125 clinical program for the treatment of acute vertigo, announcing interim results from Part A of the Phase II TRAVERS trial. In Part A of the trial, a total of 33 patients (suffering from vertigo following neurosurgery) were administered AM-125 or placebo in three dose cohorts (1mg, 10mg and 20mg) three times daily. At the highest dose (20mg), patients receiving AM-125 were able to balance themselves with eyes closed for 6.0 seconds vs. 3.1 seconds on placebo 14 days post-surgery using the ‘Tandem Romberg’ test. In a separate test where patients were asked to stand on foam, AM-125 patients stood for 10.5 seconds versus 4.3 seconds for those who received placebo. Improvement from baseline was statistically significant in all dose groups (p<0.01 to p<0.05), however this initial part of the study was not powered to show statistical significance versus placebo and this data was not provided.

The two highest doses, 10mg and 20mg three times daily, have been selected to move forward into Part B, which will be testing those doses versus placebo in 72 patients. Improvement in the standing on foam test two weeks post-surgery will be the sole primary endpoint, while the Tandem Romberg test six weeks post-surgery will be the key secondary endpoint. Enrolment is expected to begin shortly and to complete in Q121.

With regards to AM-201 for anti-psychotic induced weight gain, in May the company reported data from the 30mg dose (interim data from lower doses was announced in October 2019) of its Phase Ib study. At the 30mg dose, subjects showed a 24% reduction in weight gain following treatment with olanzapine (an anti-psychotic that causes weight gain) at the 28 day time point (2.8kg gained for those taking AM-201 in addition to olanzapine vs 3.7kg weight gain for those only on olanzapine, p<0.02, n=81). The company is preparing for both an IND filing and a Phase II trial with timing dependent on the completion of preclinical trials involving the combination of olanzapine and AM-201. An IND filing could occur as soon as Q121.


Valuation

We are adjusting our valuation to $127.1m or $17.93 per basic share, from $121.1m or $27.47 per basic share. The total value increased as we rolled forward our NPV though this was partially offset by lower net cash. The per-share value fell due to a higher number of shares outstanding as the company raised capital through both an ‘at-the-market’ offering and an equity line. We are not currently including AM-301 due to the early nature of its development.

Exhibit 1: Auris valuation table

Program

Market

Indication

Clinical stage

Probability of success

Launch
year

Peak sales ($m)

rNPV
($m)

AM-125

US

Acute vertigo

Phase II

30%

2024

88.73

$23.1

AM-125

Europe

Acute vertigo

Phase II

45%

2023

113.12

$60.3

AM-201

US

Mental health supportive care

Phase I

20%

2024

128.72

$18.4

AM-201

Europe

Mental health supportive care

Phase I

20%

2025

143.85

$25.2

Total

127.13

Net cash and equivalents (as of 30 June 2020) ($m)

(0.01)

Total firm value ($m)

127.12

Total basic shares (m)

7.1

Value per basic share ($)

17.93

Source: Edison Investment Research

Financials

Auris recently reported its H120 results. The company reported R&D expenses of CHF0.9m for the period (an additional CHF0.7m in R&D spend was capitalized) compared to CHF1.3m (with an additional CHF1.6m capitalized) in H119. G&A expenditure for H120 was CHF1.5m, down from CHF2.8m the year before. Total net loss was CHF2.7m down from CHF3.6m in the same period the year before. We have lowered our 2020 R&D estimate from CHF7.2m to CHF2m (with an additional CHF2.5m capitalized) due to lower than expected spending. Note that for the year the company has guided for CHF7.0–8.5m in total cash needs with total operating expenses of CHF4.5–5.5m and capitalized R&D of CHF2.5–3.0m. We have also reduced our FY21 R&D estimates from CHF13.2m to CHF10.0m as the company has been lowering their expenses. Note that the company capitalizes R&D expenses, but our forecasts use uncapitalized R&D expenses for FY21 and beyond so we expect reported R&D will likely be lower than our estimates (overall cash flow would be unchanged however, as that would not be affected by capitalization of R&D expenses).

As of 30 June 2020, Auris had CHF0.04m in cash and equivalents, but has raised $2.1m subsequent to the end of the period through its equity line with Lincoln Park Capital and the at-the-market (ATM) offering agreement with Alliance Global Partners (AGP). The Lincoln Park agreement was originally for up to $10m and the company has approximately $8.9m remaining under that facility. The ATM with AGP was for up to $25m and the company has approximately $22.1m remaining.

In our forecasts, we model a total of CHF50m (previously CHF65m) in additional financing needs through 2024 (including CHF22m by the end of 2021, assuming accelerated investment in all of its ongoing R&D programs), which we record as illustrative debt. An important item to note is that Auris has announced that it has initiated a review of strategic options, which may include the partnering of various programs or a sale or merger of the company as a whole.

Exhibit 2: Financial summary

CHF'000s

2018

2019

2020e

2021e

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

(6,690)

(3,325)

(2,000)

(10,000)

Selling, general & administrative

(4,265)

(3,934)

(3,072)

(3,133)

EBITDA

 

 

(11,027)

(7,290)

(5,084)

(13,146)

Operating Profit (before amort. and except.)

 

 

(10,954)

(7,259)

(5,072)

(13,133)

Intangible Amortisation

0

0

0

0

Exceptionals/Other

0

0

0

0

Operating Profit

(10,954)

(7,259)

(5,072)

(13,133)

Net Interest

(1,070)

(11)

(282)

(882)

Other (change in fair value of warrants)

690

444

(245)

0

Profit Before Tax (norm)

 

 

(12,024)

(7,270)

(5,354)

(14,015)

Profit Before Tax (IFRS)

 

 

(11,334)

(6,826)

(5,599)

(14,015)

Tax

(162)

194

11

0

Deferred tax

0

0

0

0

Profit After Tax (norm)

(12,186)

(7,076)

(5,343)

(14,015)

Profit After Tax (IFRS)

(11,496)

(6,632)

(5,589)

(14,015)

Average Number of Shares Outstanding (m)

0.8

2.9

5.8

7.2

EPS - normalised (CHF)

 

 

(15.33)

(2.43)

(0.91)

(1.95)

EPS - IFRS (CHF)

 

 

(14.46)

(2.28)

(0.96)

(1.95)

Dividend per share (CHFc)

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

 

 

3,812

6,852

9,340

9,328

Intangible Assets

3,535

6,766

9,266

9,253

Tangible Assets

34

67

54

54

Other

243

20

20

20

Current Assets

 

 

6,065

2,374

4,692

6,515

Stocks

0

0

0

0

Debtors

320

335

151

151

Cash

5,393

1,385

4,342

6,165

Other

351

654

199

199

Current Liabilities

 

 

(4,563)

(2,278)

(2,422)

(3,324)

Creditors

(3,127)

(2,278)

(2,422)

(3,324)

Short term borrowings

(1,435)

0

0

0

Long Term Liabilities

 

 

(1,665)

(912)

(8,063)

(23,063)

Long term borrowings

0

0

(7,050)

(22,050)

Other long term liabilities

(1,665)

(912)

(1,013)

(1,013)

Net Assets

 

 

3,649

6,036

3,547

(10,545)

CASH FLOW

Operating Cash Flow

 

 

(14,447)

(8,201)

(4,367)

(13,101)

Net Interest

1,053

1

0

0

Tax

162

(194)

0

0

Capex

(1,891)

(3,019)

(2,570)

(77)

Acquisitions/disposals

68

0

0

0

Financing

15,005

8,841

2,895

0

Dividends

0

0

0

0

Other

0

18

0

0

Net Cash Flow

(50)

(2,553)

(4,042)

(13,178)

Opening net debt/(cash)

 

 

(4,847)

(3,958)

(1,385)

2,707

HP finance leases initiated

0

0

0

0

Exchange rate movements

258

(8)

0

0

Other

(1,097)

(12)

(50)

0

Closing net debt/(cash)

 

 

(3,958)

(1,385)

2,707

15,885

Source: company reports, Edison Investment Research


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 2020 Edison Investment Research Limited (Edison).

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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.

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United Kingdom

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1185 Avenue of the Americas

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United States of America

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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 2020 Edison Investment Research Limited (Edison).

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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

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

1185 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

1185 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

Research: Real Estate

Deutsche Grundstücksauktionen — Group results remain resilient

In H120, Deutsche Grundstücksauktionen (DGA) reported a more than 51% y-o-y improvement in revenue from auction sales to €2.9m on a standalone basis. However, this increase was largely offset by the muted performance of its subsidiaries, with total group commission income up c 2% y-o-y to €5.8m. With a high volume of new admissions for Q320, amounting to €36.1m, the company expects the next quarter to be solid. Nevertheless, due to pandemic-driven market uncertainties, management is not providing FY20 guidance.

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