Auris Medical Holding — Data coming in second half

Auris Medical Holding — Data coming in second half

Auris recently announced that the TRAVERS Phase II trial of AM-125 (intranasal betahistine) for treating acute vertigo is being initiated at study sites as regulatory and ethics committee approvals are coming in. An interim analysis of the data is expected in Q419. Also, its AM-201 Phase I trial for olanzapine-induced weight gain reached the midpoint in enrollment in early May and is on track for full enrollment by the end of June. Top-line data is expected in Q319.

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Auris Medical Holding

Data coming in second half

Development update

Pharma & biotech

4 June 2019

Price

US$2.6

Market cap

US$11m

US$1/CHF

Net cash ($m) at 31 December 2018 + May offering

11.56

Shares in issue (estimated post offering)

4.1m

Free float

70.4%

Code

EARS

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

2.0

(12.6)

(75.3)

Rel (local)

0.3

(19.5)

(76.0)

52-week high/low

US$39.4

US$2.6

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 is entering Phase II for vertigo; both are designed to demonstrate proof-of-concept.

Next events

AM-201 PK/PD top-line readout

Q319

AM-125 Phase IIa interim readout

Q419

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 that the TRAVERS Phase II trial of AM-125 (intranasal betahistine) for treating acute vertigo is being initiated at study sites as regulatory and ethics committee approvals are coming in. An interim analysis of the data is expected in Q419. Also, its AM-201 Phase I trial for olanzapine-induced weight gain reached the midpoint in enrollment in early May and is on track for full enrollment by the end of June. Top-line data is expected in Q319.

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

(11.3)

(2.56)

0.0

N/A

N/A

12/20e

0.0

(17.2)

(3.75)

0.0

N/A

N/A

Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments. Also, prior year EPS was adjusted for the 1:20 reverse stock split in May 2019.

TRAVERS trial interim data in Q419

Auris is developing AM-125, an intranasal formulation of betahistine for the treatment of acute vertigo. As AM-125 bypasses the digestive tract where the oral compound is readily metabolized, the intranasal formulation has demonstrated superior bioavailability over oral betahistine. The Phase II trial, TRAVERS, will include 138 patients with surgically induced acute vertigo following vestibular schwannoma excision. The trial is currently being initiated at study sites with interim data expected in Q419.

AM-201 trial nearing full enrolment, data Q319

Auris also is developing AM-201, an intranasal betahistine formulation, for co-administration with olanzapine to counteract adverse effects such as weight gain and sleepiness. The company is currently enrolling the Phase I trial in Q119 in 50 healthy volunteers in Europe and is expected to complete enrolment this quarter. Data is expected in Q319.

A reverse split and capital raise

In May, the company conducted a 1-20 reverse split in order to regain Nasdaq listing compliance and also completed a public offering of shares and prepaid warrants with approximately $7.6m in net proceeds.

Valuation: $131.0m or $32.23 per basic share

We have adjusted our valuation from $123.4m or $3.29 per basic share ($2.74 per diluted share), to $131.0m or $32.23 per basic share ($29.49 per diluted share). The increase in overall valuation was primarily due to a higher level of net cash while the increase in the per share value was due to the 1-20 reverse split, which was partially offset by the dilution from the equity raise.

AM-125 TRAVERS Phase II trial coming online

Auris recently provided an update on its AM-125 clinical program for the treatment of acute vertigo. The TRAVERS trial is a randomized, controlled, double-blind Phase II trial divided into two parts (Exhibit 1) and will include 138 patients in total with surgically induced acute vertigo following the removal of vestibular schwannoma (which is a noncancerous tumor on the main nerve leading from the inner ear to the brain, also known as acoustic neuroma). Vestibular schwannoma surgery leads to loss of peripheral vestibular input, which triggers acute vertigo.

In Part A of the trial, which the company is in the process of initiating, 50 patients will be administered AM-125 or placebo in five dose cohorts three times daily and 16 patients will receive 48mg oral betahistine three times daily (open-label, for reference purposes). Dosing will begin roughly three to four days after surgery. The company plans to report interim data in Q419 and expects to determine a dose-response curve and select a low dose and a high dose of AM-125 for the second part of the trial, which will be measured against placebo. Then in Part B of the trial, the company plans to enroll 72 patients.

Exhibit 1: TRAVERS Phase II trial outline

No. of patients

Dose (three times daily)

Timeframe

Primary endpoints

Secondary endpoints

Part A

50 (experimental)

Five doses up to 20mg with AM-125

Four weeks

Standing on foam, tandem Romberg test

Tandem gait, subjective visual deviation and subjective questionnaires

16 (placebo)

48mg oral betahistine

Part B

72

High dose and low dose (determined by interim analysis) vs placebo

Four weeks

Standing on foam, tandem Romberg test

Tandem gait, subjective visual deviation and subjective questionnaires

Source: Auris Medical

Auris previously demonstrated the superior bioavailability of AM-125, intranasal betahistine, compared to oral betahistine (48mg) in both single and multiple doses (Exhibits 2 and 3) in its Phase I trial. Adverse events (AEs) were mild to moderate, described as transient and included sneezing and nasal congestion, which corresponded to dose. One patient withdrew from the trial due to an AE, but no serious AEs were reported. According to Auris, the maximum tolerated repeated dose based on local tolerability in the nose was identified and set at 40mg; the maximum tolerated single dose was not reached at 60mg.

Exhibit 2: Single-dose AM-125 bioavailability vs oral betahistine

Exhibit 3: Multi-dose AM-125 bioavailability vs oral betahistine

Source: Auris Medical

Source: Auris Medical

Exhibit 2: Single-dose AM-125 bioavailability vs oral betahistine

Source: Auris Medical

Exhibit 3: Multi-dose AM-125 bioavailability vs oral betahistine

Source: Auris Medical

AM-201 for olanzapine-induced weight gain

Auris has also initiated the Phase Ib pharmacokinetics/pharmacodynamics (PK/PD) trial in AM-201, intranasal betahistine for the prevention of olanzapine-induced weight gain. Fifty healthy volunteers are currently being enrolled at one site in Europe and the trial was halfway through enrolment as of early-May. Enrollment is expected to complete by the end of June with data in Q319. The primary and secondary endpoints are weight gain and daytime sleepiness, respectively, whereas PK analysis will assess potential drug to drug interaction.

Exhibit 4: AM-201 Phase I PK/PD trial design

Screening

Olanzapine titration

Maintenance

Male and female healthy volunteers

18–50 years of age

BMI 18–25kg/m2

Titrate up to 10mg (7.5mg) once daily within first week

Replace subjects who do not tolerate olanzapine or gain a clinically relevant amount of weight/high glucose level

Maintain olanzapine dose for three weeks

Source: Auris Medical

Valuation

We have adjusted our valuation from $123.4m or $3.29 per basic share ($2.74 per diluted share), to $131.0m or $32.23 per basic share ($29.49 per diluted share). The increase in overall valuation was primarily due to a higher level of net cash, while the increase in the per share value was due to the 1-20 reverse split, which was partially offset by the dilution from the equity raise. Note that the company has moved from quarterly to semi-annual financial reporting, hence we are using the 31 December 2018 cash level as our baseline.

Exhibit 5: Valuation of Auris Medical

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

$23.7

AM-125

Europe

Acute vertigo

Phase I

45%

2022

113.12

$59.2

AM-201

US

Mental health supportive care

Phase I

20%

2024

128.72

$15.4

AM-201

Europe

Mental health supportive care

Phase I

20%

2025

143.85

$21.1

Total

119.48

Net cash and equivalents (As of 31 December 2018 + May offering) ($m)

11.56

Total firm value ($m)

131.04

Total basic shares (May 2019 estimated, m)

4.1

Value per basic share ($)

32.23

Options and warrants (as of 31 December 2018, split-adjusted, m)

0.4

Total diluted shares (m)

4.4

Value per diluted share ($)

29.49

Source: Auris Medical reports, Edison Investment Research

Financials

As of 31 December 2018, Auris had CHF5.4m in cash and equivalents and CHF1.4m in debt. After the end of the quarter, Auris announced the full repayment of its loan facility with Hercules Capital, which eliminated the CHF1.4m in debt. In May, the company raised approximately $7.6m in net proceeds through the issuance of 440,000 shares of common stock and 1,721,280 in pre-funded warrants. In our forecasts, we model a total of CHF57.4m in financing needs through 2023 (previously CHF65m from which we subtracted the $7.6m in equity proceeds). We record this need as illustrative debt.

Exhibit 6: Financial summary

CHF000s

2017

2018

2019e

2020e

Year end 30 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)

(6,800)

(12,000)

Selling, general & administrative

(5,150)

(4,265)

(4,307)

(4,393)

EBITDA

 

 

 

(24,484)

(11,027)

(11,253)

(16,539)

Operating Profit (before amort. and except.)

 

 

 

(24,361)

(10,954)

(11,180)

(16,466)

Intangible Amortization

0

0

0

0

Exceptionals/Other

0

0

0

0

Operating Profit

(24,361)

(10,954)

(11,180)

(16,466)

Net Interest

(1,586)

(1,070)

(96)

(696)

Other (change in fair value of warrants)

1,520

690

0

0

Profit Before Tax (norm)

 

 

 

(25,947)

(12,024)

(11,276)

(17,162)

Profit Before Tax (IFRS)

 

 

 

(24,427)

(11,334)

(11,276)

(17,162)

Tax

18

(162)

0

0

Deferred tax

322

1,266

0

0

Profit After Tax (norm)

(25,929)

(12,186)

(11,276)

(17,162)

Profit After Tax (IFRS)

(24,087)

(10,230)

(11,276)

(17,162)

Average Number of Shares Outstanding (m)

2.4

0.8

4.4

4.6

EPS - normalised (CHF)

 

 

 

(10.72)

(15.33)

(2.56)

(3.75)

EPS - IFRS (CHF)

 

 

 

(9.96)

(12.87)

(2.56)

(3.75)

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

3,739

3,667

Intangible Assets

1,629

3,535

3,535

3,535

Tangible Assets

253

34

(39)

(112)

Other

77

243

243

243

Current Assets

 

 

 

15,868

6,065

3,415

2,195

Stocks

0

0

0

0

Debtors

241

320

111

170

Cash

14,973

5,393

2,953

1,674

Other

653

351

351

351

Current Liabilities

 

 

 

(10,426)

(4,563)

(3,117)

(3,986)

Creditors

(5,884)

(3,127)

(3,117)

(3,986)

Short term borrowings

(4,542)

(1,435)

0

0

Long Term Liabilities

 

 

 

(9,563)

(1,665)

(4,065)

(19,065)

Long term borrowings

(5,584)

0

(2,400)

(17,400)

Other long term liabilities

(3,979)

(1,665)

(1,665)

(1,665)

Net Assets

 

 

 

(2,162)

3,649

(27)

(17,189)

CASH FLOW

Operating Cash Flow

 

 

 

(25,827)

(14,447)

(11,005)

(16,279)

Net Interest

1,569

1,053

0

0

Tax

(18)

162

0

0

Capex

(153)

(1,891)

0

0

Acquisitions/disposals

0

68

0

0

Financing

10,308

15,005

7,600

0

Dividends

0

0

0

0

Other

(2,034)

0

0

0

Net Cash Flow

(16,154)

(50)

(3,405)

(16,279)

Opening net debt/(cash)

 

 

 

(20,078)

(4,847)

(3,958)

(553)

HP finance leases initiated

0

0

0

0

Exchange rate movements

1,316

258

0

0

Other

(393)

(1,097)

0

0

Closing net debt/(cash)

 

 

 

(4,847)

(3,958)

(553)

15,726

Source: Auris Medical Holding 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.

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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.

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New Zealand

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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.

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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1,185 Avenue of the Americas

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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 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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

United Kingdom

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

Research: Healthcare

Oxford Biomedica — In a cell and gene therapy sweet spot

Oxford Biomedica (OXB) is a pioneer and global leader in the development and manufacture of commercial-scale lentiviral vectors (LVV), a critical component of cell and gene therapies (CGT). OXB has numerous value streams, including manufacturing, royalties and milestones on partnered product sales. Its technology and R&D pipeline have been validated by numerous partnerships (Novartis’s CAR-T Kymriah, Axovant deal for AXO-Lenti-PD). We believe the greatest opportunity lies in OXB’s own gene therapy R&D capabilities; higher investment now is imperative to reap future economic returns in this highly innovative and potentially lucrative therapy area. We value OXB at £649m.

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