Contrave outperforming

Orexigen Therapeutics 17 August 2017 Update
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Orexigen Therapeutics

Contrave outperforming

Financial update

Pharma & biotech

17 August 2017

Price

US$2.44

Market cap

US$38m

Net debt ($m) at 30 June 2017

85

Shares in issue

15.4m

Free float

66.1%

Code

OREX

Primary exchange

NASDAQ

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(15.3)

(25.6)

(42.9)

Rel (local)

(15.6)

(27.6)

(49.6)

52-week high/low

US$5.4

US$1.7

Business description

Orexigen Therapeutics is a biopharmaceutical company focusing on obesity treatments. It recently reacquired the rights to sell its sole product, weight management treatment Contrave, in the US from its previous partner, Takeda. Contrave was launched in the US in October 2014 and approved in the EU in March 2015 under the trade name Mysimba.

Next events

Contrave patent litigation decision

September/October 2017

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Orexigen Therapeutics is a research client of Edison Investment Research Limited

Orexigen’s re-launch of Contrave continues to be successful, with an 18% increase in prescriptions in the United States in Q217 compared to Q117. Importantly, net revenue per unit sold increased 37%, indicating better coverage and less discounting. Outside of the US, progress continues as the product has launched in 17 countries, with another 10-15 expected by Q118, including Germany and Italy. The company has also announced that it has commenced an exploration of strategic transactions as a means to maximize the value creation for shareholders.

Year
end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/15

24.5

(67.3)

(5.24)

0.0

N/A

N/A

12/16

33.7

(138.1)

(9.73)

0.0

N/A

N/A

12/17e

94.0

(141.4)

(7.96)

0.0

N/A

N/A

12/18e

160.3

(72.7)

(4.67)

0.0

N/A

N/A

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

Continued success in patient-centric campaign

A shift from previous partner Takeda’s healthcare provider-focused marketing to a campaign focused on consumers (but with continued detailing of high prescribing physicians) has yielded a dramatic increase in prescriptions. Prescriptions increased 39% in Q117 compared to the prior quarter and a further 18% in Q217. They now have approximately 50% of the branded obesity market (~8.5% of the total) according to Symphony Health.

10-15 more international launches by Q118

Contrave (Mysimba outside the US) has now launched in 17 countries, including South Korea, the UK, Spain and Poland. Launches in Germany, Italy and the Nordic countries (Denmark, Finland, Norway and Sweden) are expected in Q417. Orexigen is partnered in a total of 48 countries outside of the US.

Strategic review commenced

Orexigen has announced that it has formally engaged with a financial advisor to help explore strategic transactions to unlock value for shareholders. Whether that means acquiring an on-market product that is being divested from somewhere else or selling the company is unclear, though both moves make sense due to the tremendous operating synergies from selling multiple products with one salesforce.

Valuation: $214m or $13.87 per share

We are adjusting our valuation to $214m ($13.87/share), from $194m ($12.76/share). This is mainly due to higher 2017 Contrave estimates and rolling forward our NPV, and was mitigated by a higher net debt level as well as a larger number of shares. Orexigen’s financing requirement is $90m through to 2020, although this does not include the $238m in convertible debt due in that year.

Quarterly update

The re-launch of Contrave with a more patient-centric marketing campaign continues to pay dividends. Quarterly net sales increased 40% over the prior quarter and prescriptions increased 18% over the prior quarter. Importantly, the net revenue per unit sold increased to $96, 37% higher than in Q216. This is also an 8% sequential improvement over the $89 figure last quarter and surpasses the original 2017 guidance of $85-90 in net revenue per unit sold. This indicates improving coverage as well as less discounting.

Based on prescription data from Symphony Health, this strategy has been particularly effective, increasing Contrave’s market share by 10% to close to 50% of the branded obesity market (8.5% of the total market, which includes phentermine) since the consumer campaign started at the beginning of 2017 (see Exhibit 1). There has been a bit of a dip since the beginning of June, which is likely the result of less television advertising. It bears watching but given how much share it has gained, it is not surprising that it would give back a few points.

Exhibit 1: Market share in the branded obesity market

Source: Symphony Health

International momentum continues

Contrave, which is known as Mysimba in most international markets, has now launched in 17 countries (see Exhibit 2), including South Korea, the UK, Spain and Poland. Launches in Germany, Italy and the Nordic countries (Denmark, Finland, Norway and Sweden) are expected in Q417. Orexigen’s goal is to launch in a total of 10-15 additional countries by Q118 as well as find partners in an additional 10-15 countries this year (focused on Latin America and Europe). For the first time, the company has recently included OUS net sales guidance of $10-15m into its 2017 guidance (there have been $7m in OUS net sales through Q217).

Exhibit 2: International Contrave launch timelines

Country

Partner

Launch date

Notes

South Korea

Kwangdong

Q216

Czech Republic

Valeant

Q416

Slovakia

Valeant

Q416

Hungary

Valeant

Q416

Poland

Valeant

Q416

Romania

Valeant

Q416

Spain

ROVI

Q117

Bulgaria

Valeant

Q117

Estonia

Valeant

Q117

Lithuania

Valeant

Q117

Latvia

Valeant

Q117

Croatia

Valeant

Q117

Slovenia

Valeant

Q117

Greece

Valeant

Q217

UK

Consilient Health

Q217

Ireland

Consilient Health

Q217

Cyprus

Valeant

Q317e

Italy

Bruno

Q417e

Denmark

Navamedic ASA

Q417e

Finland

Navamedic ASA

Q417e

Norway

Navamedic ASA

Q417e

Sweden

Navamedic ASA

Q417e

Malta

Valeant

Q417e

Austria

Cheplapharm

Q417e

Germany

Cheplapharm

Q417e

Serbia

Valeant

Q118e

Saudi Arabia

Biologix FZCO

Q118e

Regulatory submission Q317

Kuwait

Biologix FZCO

Q118e

Regulatory submission Q217

Lebanon

Biologix FZCO

Q118e

Regulatory submission Q217

UAE

Biologix FZCO

Q118e

Regulatory submission Q217

Canada

Valeant

2018e

Regulatory submission Q117

Australia

Valeant

2018e

Regulatory submission Q217

Turkey

Valeant

2018e

Regulatory submission expected Q317

South Africa

Valeant

2018e

Regulatory submission expected Q317

Source: Orexigen Therapeutics

Evaluating strategic options

The company has announced that it has formally engaged with a financial advisor to help explore strategic transactions to unlock value for shareholders. Whether that means acquiring an on-market product that is being divested from somewhere else or selling the company is unclear, though both moves make sense due to the tremendous operating synergies from selling multiple products with one salesforce. It will likely be easier for it to acquire a new product rather than sell itself to someone else, as just about every specialty pharma (for example Valeant) and large pharma (for example GSK) appears to be divesting a large numbers of assets.

The value of the Contrave asset will likely improve in the eyes of partners when the Paragraph IV litigation with Actavis over its filing for approval of a generic version of Contrave is successfully concluded. As a reminder, in April 2015, notice of a Paragraph IV certification regarding an abbreviated new drug application (ANDA), the type of application needed to get a generic approved, was received. In June 2016, following a May 2016 claim construction hearing, the court adopted Orexigen’s proposed constructions with regard to the majority of the disputed claim terms in a Markman ruling. The trial was in June of this year and Orexigen believes it went as expected and that it has a strong case. There should be a ruling from the judge in the September/October timeframe.

Valuation

We are adjusting our valuation to $214m ($13.87/share) from $194m ($12.76/share). This is mainly a result of improved 2017 Contrave estimates due to a higher than expected run rate of sales and rolling forward our NPV, and was mitigated by a higher net debt level as well as a larger number of shares. Orexigen’s financing requirement is $90m through to 2020, although this does not include the $238m in convertible debt due in that year.

Exhibit 3: Orexigen valuation table

Product

Launch

Peak sales ($m)

Royalty rate

NPV ($m)

rNPV/share ($)

Contrave US

Oct-14

342

100%

1,708

110.71

Contrave W. Europe

2016

118

30%

133

8.63

Contrave C. and E. Europe

2016

27

37.5%

35

2.28

Contrave S. Korea

2016

15

37.5%

15

0.98

Contrave ROW

2017

15

37.5%

15

0.96

PV costs including taxes

(1,608)

(104.20)

Net cash/(debt) (30 June 2017)

(84.91)

(5.50)

Overall valuation (per share based on 15.4m shares outstanding)

214

13.87

Source: Edison Investment Research

Financials

Sales of Contrave in the US were $20.7m in Q217, up 69% compared to Q216 and up 40% compared to Q117. Orexigen also booked $2.7m in sales of Contrave to international partners. Operating expenses were $58.5m in the quarter, down 12% compared to the previous quarter due mainly to lower SG&A. These expenses are expected to continue to decline over the course of the year. Following the recent results, we have increased our revenue estimates in 2017 by $5m, increased our SG&A expense estimates for 2017 by $10m due to a higher than expected run rate (although the expense itself is decreasing quarter to quarter), and also decreased our R&D expense estimates by around $2m per year as the run rate has been lower than we expected. The company had $86.6m in cash and marketable securities at the end of Q217 and continues to guide for a cash balance of $40-50m at the end of 2017. Note that while Orexigen currently lists $172m in long-term convertible debt on its balance sheet, it actually owes $238m in principal value on these notes, which will need to be paid in 2020 ($165m by 1 July 2020 and the rest on 1 December). The difference is due to rules related to the fair value accounting of convertible notes with liability and equity components.

Exhibit 4: Financial summary

$000s

2015

2016

2017e

2018e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

24,459

33,709

94,025

160,251

Cost of Sales

0

(7,995)

(28,111)

(29,680)

Gross Profit

24,459

25,714

65,914

130,572

Research and development

(40,750)

(38,023)

(30,926)

(34,019)

Selling, general & administrative

(43,762)

(118,583)

(173,126)

(164,470)

EBITDA

 

 

(60,276)

(134,627)

(138,255)

(68,092)

Operating Profit (before amort. and except.)

 

 

(60,053)

(130,892)

(138,138)

(67,916)

Intangible Amortization

0

(3,307)

(7,936)

(5,769)

Exceptionals/Other

0

77,229

(2,100)

0

Operating Profit

(60,053)

(56,970)

(148,174)

(73,685)

Net Interest

(7,219)

(7,228)

(3,264)

(4,769)

Other (includes change in fair value of warrants)

(39)

39,807

(1,997)

0

Profit Before Tax (norm)

 

 

(67,272)

(138,120)

(141,402)

(72,685)

Profit Before Tax (FRS 3)

 

 

(67,311)

(24,391)

(153,435)

(78,454)

Tax

(1,376)

(133)

0

0

Deferred tax

0

0

0

0

Profit After Tax (norm)

(68,648)

(138,253)

(141,402)

(72,685)

Profit After Tax (FRS 3)

(68,687)

(24,524)

(153,435)

(78,454)

Average Number of Shares Outstanding (m)

13.1

14.6

15.2

15.5

EPS - normalized ($)

 

 

(5.24)

(9.73)

(7.96)

(4.67)

EPS - FRS 3 ($)

 

 

(5.24)

(9.73)

(7.96)

(4.67)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

2,694

79,940

71,283

65,339

Intangible Assets

0

76,061

68,125

62,356

Tangible Assets

1,284

1,044

584

409

Other

1,410

2,835

2,574

2,574

Current Assets

 

 

233,895

224,461

87,070

48,091

Stocks

10,802

23,193

15,753

15,753

Debtors

6,828

1,102

7,636

7,636

Cash

214,011

103,993

59,358

20,379

Other

2,254

96,173

4,323

4,323

Current Liabilities

 

 

(32,241)

(65,360)

(41,804)

(41,804)

Creditors

(32,241)

(65,360)

(41,804)

(41,804)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

(170,970)

(178,842)

(206,563)

(225,950)

Long term borrowings

(88,129)

(166,179)

(191,529)

(211,529)

Other long term liabilities

(82,841)

(12,663)

(15,034)

(14,421)

Net Assets

 

 

33,378

60,199

(90,015)

(154,324)

CASH FLOW

Operating Cash Flow

 

 

(54,473)

(109,713)

(137,316)

(59,137)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(538)

(330)

0

0

Acquisitions/disposals

0

(63,504)

(3,414)

0

Financing

64,259

188

0

0

Dividends

0

0

0

0

Other

(3,843)

(15,424)

76,073

188

Net Cash Flow

5,405

(188,783)

(64,657)

(58,949)

Opening net debt/(cash)

 

 

(121,629)

(125,882)

62,186

132,171

HP finance leases initiated

0

0

0

0

Exchange rate movements

29

715

0

0

Other

(1,181)

0

(5,328)

(30)

Closing net debt/(cash)

 

 

(125,882)

62,186

132,171

191,150

Source: Orexigen Therapeutics accounts, Edison Investment Research


Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Orexigen Therapeutics and prepared and issued by Edison for publication globally. 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. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US 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. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and 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 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. This document is provided 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.
Edison has a restrictive policy relating to personal dealing. 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. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. 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. 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 (ie 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. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “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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295 Madison Avenue, 18th Floor

10017, New York

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Sydney +61 (0)2 8249 8342

Level 12, Office 1205

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Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Orexigen Therapeutics and prepared and issued by Edison for publication globally. 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. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US 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. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and 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 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. This document is provided 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.
Edison has a restrictive policy relating to personal dealing. 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. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. 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. 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 (ie 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. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “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.

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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, 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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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