Hutchison China MediTech — Fortune favours the brave

HUTCHMED (US: HCM)

Last close As at 28/03/2024

31.59

−2.99 (−8.65%)

Market capitalisation

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Research: Healthcare

Hutchison China MediTech — Fortune favours the brave

Notwithstanding the COVID-19 pandemic challenges, Hutchison China MediTech (HCM) remains on track for potential approval and launches of two additional assets (surufatinib and savolitinib) in China in 2020/21. HCM is actively engaging with regulators (including the China NMPA and US FDA) with regards to trial initiations and NDA submissions as it continues on its trajectory to a global innovative oncology company. Furthermore, given the broader pipeline progression, it has a high level of visibility on data submission to regulators and international scientific conferences this year, including ASCO, AACR and ESMO. Importantly, with the China COVID-19 experience under its belt, HCM is positioned to capitalise on its experience of conducting business in a COVID-19 environment. We expect 2022/23 to benefit from global drug launches providing continued pipeline progression.

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Written by

Healthcare

Hutchison China MediTech

Fortune favours the brave

COVID-19 impact update

Pharma & biotech

22 April 2020

Price

302.0p

Market cap

£2,086m

$1.30/£

Net cash ($m) and short-term investments at end 2019 + net proceeds of $110m raise

300

Shares in issue

690.6m

Free float

52%

Code

HCM

Primary exchange

AIM/Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

15.7

(34.0)

(35.8)

Rel (local)

(2.5)

(19.9)

(31.9)

52-week high/low

460.0p

258.0p

Business description

Hutchison China MediTech is an innovative China-based biopharmaceutical company targeting the global market for novel, highly selective oral oncology and immunology drugs. Its established commercial platform business continues to expand its outreach.

Next events

Surufatinib China NDA file for pancreatic NET

H120

Surufatinib start global PIII NET trials

H120

Savolitinib China NDA file for NSCLC MET exon 14 deletion

H120

Fruquintinib start FRESCO2 global PIII CRC trial

2020

Analyst

Dr Susie Jana

+44 (0)20 3077 5700

Hutchison China MediTech is a research client of Edison Investment Research Limited

Notwithstanding the COVID-19 pandemic challenges, Hutchison China MediTech (HCM) remains on track for potential approval and launches of two additional assets (surufatinib and savolitinib) in China in 2020/21. HCM is actively engaging with regulators (including the China NMPA and US FDA) with regards to trial initiations and NDA submissions as it continues on its trajectory to a global innovative oncology company. Furthermore, given the broader pipeline progression, it has a high level of visibility on data submission to regulators and international scientific conferences this year, including ASCO, AACR and ESMO. Importantly, with the China COVID-19 experience under its belt, HCM is positioned to capitalise on its experience of conducting business in a COVID-19 environment. We expect 2022/23 to benefit from global drug launches providing continued pipeline progression.

Year end

Revenue (US$m)

Net profit*
(US$m)

EPS*
(c)

DPS
(c)

P/E
(x)

Yield
(%)

12/18

214.1

(74.8)

(11.3)

0.0

N/A

N/A

12/19

204.9

(106.0)

(15.9)

0.0

N/A

N/A

12/20e

216.8

(161.1)

(23.3)

0.0

N/A

N/A

12/21e

287.9

(165.2)

(23.9)

0.0

N/A

N/A

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

Lessons learned from the China COVID-19 curve

HCM has been dealing with COVID-19 disruptions, which have affected China for months. It has navigated these unchartered waters and is applying lessons learnt to best practice in these challenging times. Its China commercial business and manufacturing operations have not been materially affected so far. China’s NMPA has been actively reviewing surufatinib (NDA under review) and HCM expects to file two further NDAs during the year (NDA submission pending for surufatinib in pNET and savolitinib in MET exon 14 deletion NSCLC). We also note that sales of Elunate (third-line CRC) in January/February grew significantly post NRDL inclusion vs FY19 despite deployment of clinical resource to COVID-19, which highlights the continuation of care in severe conditions such as cancer.

Well capitalised to weather the storm

Preparations to initiate global registration studies are expected to complete mid-year for fruquintinib in 3/4L CRC and surufatinib in NET (the US FDA has granted two fast track designations for pNET and epNET). Savolitinib could be the first of HCM’s innovation assets to launch globally in 2022 (for MET-positive EGFR refractory NSCLC in combination with Tagrisso, a blockbuster opportunity) through partner AZN. HCM is well funded with available cash resources of >$300m (at 31 December 2019) at group level and the recent capital raise of $110m (net proceeds) provides additional funding flexibility as R&D is set to increase to support global registration studies this year.

Valuation: $5.9bn (£6.55/share)

Our valuation is unchanged at $5.9bn (£6.55/share). Our valuation includes net cash of $190m at end December 2019 plus $110m net proceeds from the January 2020 capital raise.

Learning from COVID-19 impact in China

At its FY19 results, we note that management advised: ‘The outbreak is posing some challenges to our operations resulting from restrictions on movement in China. Reduced patient hospital visits for clinical assessment affected the conduct of certain clinical studies and commercial team activities. To-date, none of our manufacturing operations in China have been materially affected. Our teams have adapted quickly and effectively thus far across our businesses, and we will continue to closely monitor what is an evolving situation. At this stage we are unable to assess the long-term effect of the outbreak, if any. We assume at this stage that the financial impact of the recent COVID-19 outbreak will not be material to the Group. Since we cannot predict how the situation will evolve, we will monitor and adjust if new material information emerges.’

Following on from this, our observations are:

Eli Lilly (LLY) reported Elunate sales of $6.6m in January to February 2020 vs $17.6m in FY19 despite the challenges of COVID-19 (and Chinese New Year), which highlights its inclusion on the National Reimbursement Drug List (NRDL) and the continuation of care for severe conditions such as cancer in the face of healthcare resources deployed to treating COVID-19. Hospital visits are being deferred in some cases, so patients may be receiving prescription drugs in earlier lines of treatment. HCM’s China commercial business and manufacturing operations have not been materially affected so far.

In terms of how HCM has managed disruptions to clinical trial sites, the company has been performing remote follow-ups with patients where possible, clinical protocols have not been compromised. We would anticipate some delays in patient recruitment in the global registration studies, but this will vary from country to country depending on factors such as individual healthcare systems. FDA has given guidance on dealing with the impacts of COVID-19 and maintaining clinical trial data integrity. We note that the company has successfully initiated a Phase II trial of HMPL-453 (pan-FGFR inhibitor) in China in patients with advanced mesothelioma.

HCM is maintaining active dialogue with China’s National Medical Products Administration (NMPA) which has been reviewing the NDA filing for surufatinib (accepted for non-pancreatic neuroendocrine tumours [NET]), and we still expect potential approval and launch in late 2020. HCM is on track for two further China NDA submissions (savolitinib in MET exon 14 deletion NSCLC and surufatinib in pancreatic NET) this year. In the US, the FDA recently (17 April 2020) granted two fast track designations for surufatinib in pNET and epNET, highlighting the unmet need in the treatment of neuroendocrine tumours.

HCM is in a strong financial position after ADS issuance on 21 January 2020 (the underwriters also exercised an over-allotment option). The recent capital raise of $110m (net proceeds) provides additional funding flexibility as R&D is set to increase to support global registration studies. HCM reported available cash resources of more than $300m (at 31 December 2019) at group level (cash and cash equivalents including short-term investments of $217.2m, and unutilised bank borrowing facilities of $119.3m).

We believe the long-term investment case is underpinned by multiple near-term catalysts that demonstrate HCM’s ability to discover and develop drugs, and its success rate as defined by drug approvals and launches. The launch of Elunate in China with partner LLY and subsequent inclusion on China’s exclusive NRDL are significant milestones, giving us confidence in HCM’s ability to execute on its R&D philosophy of building first- or best-in-class molecules with lower toxicity profiles to enable combination-based strategies for the treatment of cancers. Despite the challenges faced by COVID-19, 2020 is a golden year for HCM: it is scaling up its China oncology commercial presence ahead of surufatinib expected launch in late 2020 and the expected NDA submissions for surufatinib in pancreatic NET and savolitinib in MET exon 14 deletion NSCLC (anticipated 2021 launch). Clinical and regulatory teams are now fully operational in the US and EU. HCM’s first global approval (we forecast launch in 2022) in the US/EU could be for a savolitinib combination with AstraZeneca’s (AZN) Tagrisso in MET-positive EGFRm NSCLC. Global registration studies planned (no change) to start in 2020 include fruquintinib in 3/4L colorectal cancer (CRC) and surufatinib in NET. For further details, see our note From innovation to oncology commercialisation published in March 2020.

Exhibit 1: Financial summary

US$'000s

 

2017

2018

2019

2020e

2021e

Year end December

US GAAP

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

241,203

214,109

204,890

216,750

287,863

Cost of Sales

(175,820)

(143,944)

(160,152)

(175,913)

(196,289)

Gross Profit

65,383

70,165

44,738

40,836

91,574

Research and development

(75,523)

(114,161)

(138,191)

(184,000)

(210,500)

Other overheads

(43,277)

(48,645)

(52,934)

(54,521)

(76,679)

EBITDA

 

 

(50,692)

(88,975)

(141,250)

(191,948)

(183,546)

Operating Profit (before amort. and except.)

 

 

(53,417)

(92,641)

(146,387)

(197,684)

(195,605)

Intangible Amortisation

0

0

0

0

0

Operating Profit

(53,417)

(92,641)

(146,387)

(197,684)

(195,605)

Net Interest

(235)

4,969

3,914

2,129

(2,991)

Exceptionals

0

0

0

0

0

Profit Before Tax (norm)

 

 

(53,536)

(86,655)

(141,106)

(195,555)

(198,596)

Profit Before Tax (reported)

 

 

(53,536)

(86,655)

(141,106)

(195,555)

(198,596)

Tax

(3,080)

(3,964)

(3,274)

(3,300)

(5,000)

Equity investments, after tax

33,653

19,333

40,700

42,769

43,418

Profit After Tax (norm)

(22,963)

(71,286)

(103,680)

(156,086)

(160,178)

Profit After Tax (reported)

(22,963)

(71,286)

(103,680)

(156,086)

(160,178)

Minority

(3,774)

(3,519)

(2,345)

(5,000)

(5,000)

Discontinued operations

0

0

0

0

0

Net profit (norm)

(26,737)

(74,805)

(106,025)

(161,086)

(165,178)

Net profit (reported)

(26,737)

(74,805)

(106,025)

(161,086)

(165,178)

Average Number of Shares Outstanding (m)

617.2

664.3

665.7

690.7

690.7

EPS - normalised (c)

 

 

(4.3)

(11.3)

(15.9)

(23.3)

(23.9)

EPS - normalised and fully diluted (c)

 

 

(4.3)

(11.3)

(15.9)

(23.3)

(23.9)

EPS - (reported) (c)

 

 

(4.3)

(11.3)

(15.9)

(23.3)

(23.9)

Average number of ADS outstanding (m)

123.4

132.9

133.1

138.1

138.1

Earnings per ADS - normalised ($)

 

 

(0.02)

(0.06)

(0.08)

(0.12)

(0.12)

Earnings per ADS ($)

 

 

(0.02)

(0.06)

(0.08)

(0.12)

(0.12)

BALANCE SHEET

Fixed Assets

 

 

165,737

161,577

148,100

163,759

206,624

Intangible Assets

3,738

3,533

3,387

3,100

2,497

Tangible Assets

14,220

16,616

20,855

23,970

54,412

Investments

147,779

141,428

123,858

136,689

149,714

Current Assets

 

 

432,195

370,541

317,022

266,040

270,085

Stocks

11,789

12,309

16,208

14,459

16,133

Debtors

53,566

56,392

59,023

53,445

23,660

Cash

85,265

86,036

121,157

173,513

205,669

St investments

273,031

214,915

96,011

0

0

Other

8,544

889

24,623

24,623

24,623

Current Liabilities

 

 

(104,600)

(85,479)

(113,101)

(125,868)

(124,956)

Creditors

(25,344)

(26,180)

(25,789)

(38,556)

(37,644)

Short term borrowings

(29,987)

0

0

0

0

Other

(49,269)

(59,299)

(87,312)

(87,312)

(87,312)

Long Term Liabilities

 

 

(8,366)

(34,383)

(39,118)

(39,118)

(249,118)

Long term borrowings

0

(26,739)

(26,818)

(26,818)

(236,818)

Other long term liabilities

(8,366)

(7,644)

(12,300)

(12,300)

(12,300)

Net Assets

 

 

484,966

412,256

312,903

264,813

102,635

Minority

(23,233)

(23,259)

(24,891)

(29,891)

(34,891)

Shareholder equity

 

 

461,733

388,997

288,012

234,922

67,744

CASH FLOW

Operating Cash Flow

 

 

(8,943)

(32,847)

(80,912)

(143,085)

(133,945)

Net Interest

0

0

0

0

0

Tax

0

0

0

0

0

Capex

(5,019)

(6,364)

(8,565)

(8,565)

(41,898)

Acquisitions/disposals

0

0

8,689

0

0

Dividends

(1,594)

(1,282)

(1,282)

(2,000)

(2,000)

Equity financing and capital movements

291,737

(2,322)

(95)

110,000

0

Other

(255,761)

50,116

118,904

96,006

0

Net Cash Flow

20,420

7,301

36,739

52,356

(177,844)

Opening net debt/(cash)

 

 

(56,914)

(328,309)

(274,212)

(190,350)

(146,695)

Increase/(decrease) in ST investments

248,761

(58,116)

(118,904)

(96,011)

0

Other

2,214

(3,282)

(1,697)

0

0

Closing net debt/(cash)

 

 

(328,309)

(274,212)

(190,350)

(146,695)

31,149

Source: Company accounts, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by Hutchison China MediTech and prepared and issued by Edison, in consideration of a fee payable by Hutchison China MediTech. 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).

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.

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

General disclaimer and copyright

This report has been commissioned by Hutchison China MediTech and prepared and issued by Edison, in consideration of a fee payable by Hutchison China MediTech. 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).

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.

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

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Auris Medical Holding — AM-201 data expected in early May

Auris has announced that final data from its 80-subject AM-201 Phase Ib trial for olanzapine-induced weight gain and somnolence should be available in early May. The key component of this release will be the data from the final dose level of 30mg in 30 healthy volunteers (we had previously only seen data in patients dosed up to 20mg). Due to the coronavirus, enrolment has been paused in the Phase II TRAVERS trial of 118 patients with surgically induced acute vertigo. Interim data from Part A of that trial now will likely not be available until Q320 at the earliest.

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