FDA accepts TALICIA’s NDA

RedHill Biopharma 11 July 2019 Update
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RedHill Biopharma

FDA accepts TALICIA’s NDA

FDA accepts TALICIA’s NDA

Pharma & biotech

11 July 2019

Price

US$6.59

Market cap

US$187m

NIS3.60/US$

Net cash ($m) at end Q119

45.5

Shares in issue

283.7m

Free float

90%

Code

RDHL

Primary exchange

TASE

Secondary exchange (ADS 1:10)

NASDAQ

Share price performance

%

1m

3m

12m

Abs

(8.6)

(23.5)

(32.3)

Rel (local)

(11.8)

(26.1)

(36.8)

52-week high/low

US$11.4

US$5.2

Business description

RedHill is a speciality company with an R&D pipeline focusing on gastrointestinal (GI) and inflammatory diseases; earlier-stage assets also target various cancers. The most advanced products are TALICIA for H. pylori infection, RHB-104 for Crohn’s disease, RHB-204 for nontuberculous mycobacteria (NTM) infections and BEKINDA for gastroenteritis and IBS-D. RedHill also promotes four GI products in the US.

Next events

Expected FDA response on TALICIA’s NDA

2 November 2019

Initiation of pivotal Phase III trial with RHB-204 for NTM infections

H219

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Alice Nettleton

+44 (0)20 3077 5700

RedHill Biopharma is a research client of Edison Investment Research Limited

On 3 July 2019, RedHill announced that the FDA has accepted for review the new drug application (NDA) for TALICIA for the treatment of Helicobacter pylori infection. As TALICIA is a designated Qualified Infectious Disease Product (QIDP), the FDA also granted a priority review, which will shorten the usual review time from the standard 10 months to six months. As a result, 2 November 2019 was set as the target Prescription Drug User Fee Act (PDUFA) date. Based on the data released, we assign a high likelihood of FDA approval due to the clean dataset from the Phase III trials. If approved, TALICIA could be launched by end 2019.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/17

4.0

(45.5)

(0.26)

0.0

N/A

N/A

12/18

8.4

(38.8)

(0.17)

0.0

N/A

N/A

12/19e

10.0

(36.5)

(0.13)

0.0

N/A

N/A

12/20e

13.0

(35.8)

(0.13)

0.0

N/A

N/A

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

Clean Phase III dataset

Top-line results from the TALICIA (rifabutin, amoxicillin and omeprazole) confirmatory Phase III study (ERADICATE Hp2) in first-line treatment of H. pylori infection regardless of ulcer status were announced on 3 December 2018. The primary endpoint, H. pylori eradication rate with TALICIA vs the active comparator of amoxicillin + omeprazole, was met with high statistical significance (p<0.0001). The TALICIA treatment group achieved an 84% eradication rate (n=228) vs 58% with the active comparator (n=227). TALICIA was found to be safe and well tolerated. Notably, the culture results showed that resistance rates to the most common antibiotics metronidazole and clarithromycin were 44% and 17% respectively, while no resistance to rifabutin was seen. This confirmed the widely acknowledged fact that H. pylori front-line treatment is ineffective in many cases.

TALICIA could be launched before end-2019

RedHill plans to use its existing commercial platform to market TALICIA to healthcare practitioners and expects a minimal incremental cost of launch (several senior new hires were announced in May). Commercial manufacturing is already in scale-up mode and RedHill is ready to start discussions with payors. We believe TALICIA is a potentially very interesting proposition. The 2017 ACG Guidelines describe therapies that include rifabutin as a salvage treatment, citing ‘moderate quality of evidence’, rifabutin cost and rare but serious safety concerns, but note a very low H. pylori resistance rate to rifabutin. RedHill’s Phase III programme (two large trials) should address any residual data quality concerns and confirm the efficacy. Safety data appear excellent at the lower doses used in the trial.

Valuation: $518m or $18.3 per ADS

We keep our RedHill valuation unchanged at $518m or $18.3 per ADS (SOTP breakdown published in 28 May 2019 report). TALICIA’s launch is the main catalyst this year, while the planned initiation of the pivotal Phase III study with RHB-204 for non-tuberculous mycobacteria infections (NTMs) in H219 is a notable R&D event.

Exhibit 1: Financial summary

$'000s

 

2016

2017

2018

2019e

2020e

December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

101

4,007

8,360

10,000

13,000

Cost of Sales

0

(2,126)

(2,837)

(3,500)

(4,550)

Gross Profit

101

1,881

5,523

6,500

8,450

Research and development

(25,241)

(32,969)

(24,862)

(22,684)

(22,976)

EBITDA

 

 

(30,499)

(51,891)

(39,241)

(36,451)

(35,682)

Operating Profit (before amort. and except.)

(30,543)

(51,972)

(30,543)

(51,972)

(39,331)

Intangible Amortisation

0

0

0

0

0

Exceptionals

0

0

0

0

0

Other

0

0

0

0

0

Operating Profit

(30,543)

(51,972)

(39,331)

(36,545)

(35,781)

Net Interest

1,173

6,428

511

0

0

Profit Before Tax (norm)

 

 

(29,370)

(45,544)

(38,820)

(36,545)

(35,781)

Profit Before Tax (reported)

 

 

(29,370)

(45,544)

(38,820)

(36,545)

(35,781)

Tax

0

0

0

0

0

Profit After Tax (norm)

(29,370)

(45,544)

(38,820)

(36,545)

(35,781)

Profit After Tax (reported)

(29,370)

(45,544)

(38,820)

(36,545)

(35,781)

Average Number of Shares Outstanding (m)

128.5

128.5

176.6

231.2

283.8

EPS - normalised ($)

 

 

(0.23)

(0.26)

(0.17)

(0.13)

(0.13)

EPS - normalised ($)

 

 

(0.24)

(0.26)

(0.17)

(0.13)

(0.13)

EPS - (reported) ($)

 

 

(0.23)

(0.26)

(0.17)

(0.13)

(0.13)

Dividend per share ($)

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

46.9

66.1

65.0

65.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

6,397

5,667

5,623

5,587

5,546

Intangible Assets

6,095

5,285

5,320

5,355

5,390

Tangible Assets

165

230

163

92

16

Investments

137

152

140

140

140

Current Assets

 

 

67,815

51,676

56,788

23,832

5,134

Stocks

0

653

769

1,300

1,300

Debtors

1,661

4,818

2,834

2,834

2,834

Cash

53,786

16,455

29,005

19,698

1,000

Other*

12,368

29,750

24,180

0

0

Current Liabilities

 

 

(5,356)

(11,830)

(10,381)

(11,457)

(11,457)

Creditors

(5,356)

(11,830)

(10,381)

(11,457)

(11,457)

Short term borrowings

0

0

0

0

0

Long Term Liabilities

 

 

(6,155)

(448)

(844)

(1,300)

(15,664)

Long term borrowings

0

0

0

0

(14,364)

Other long term liabilities

(6,155)

(448)

(844)

(1,300)

(1,300)

Net Assets

 

 

62,701

45,065

51,186

16,662

(16,440)

CASH FLOW

Operating Cash Flow

 

 

(28,258)

(44,769)

(34,462)

(32,929)

(33,004)

Net Interest

0

0

0

0

0

Tax

0

0

0

0

0

Capex

(85)

(146)

(23)

(23)

(23)

Acquisitions/disposals

0

0

0

0

0

Financing

36,017

25,653

42,263

0

0

Other**

24,596

(18,069)

4,772

23,645

(35)

Dividends

0

0

0

0

0

Net Cash Flow

32,270

(37,331)

12,550

(9,307)

(33,062)

Opening net debt/(cash)

 

 

(21,516)

(53,786)

(16,455)

(29,005)

(19,698)

HP finance leases initiated

0

0

0

0

0

Other

0

0

0

0

0

Closing net debt/(cash)

 

 

(53,786)

(16,455)

(29,005)

(19,698)

13,364

Source: RedHill’s accounts, Edison Investment Research. Note: *Bank deposits and financial assets at fair value. **Includes bank deposits converted to cash and cash equivalents.


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This report has been commissioned by RedHill Biopharma and prepared and issued by Edison, in consideration of a fee payable by RedHill Biopharma. 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 Edison analyst 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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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

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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 RedHill Biopharma and prepared and issued by Edison, in consideration of a fee payable by RedHill Biopharma. 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 Edison analyst 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.

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

Neither this document and associated email (together, the "Communication") constitutes or form part of any offer for sale or subscription of, or solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it form the basis of, or be relied on in connection with, any contract or commitment whatsoever. Any decision to purchase shares in the Company in the proposed placing should be made solely on the basis of the information to be contained in the admission document to be published in connection therewith.

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 (nor will such persons be able to purchase shares in the placing).

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

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