Vernalis — Update 5 January 2017

Vernalis — Update 5 January 2017

Vernalis

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Vernalis

Advancing towards a commercial portfolio

CCP-008 NDA acceptance

Pharma & biotech

5 January 2017

Price

33.5p

Market cap

£176m

$1.29/£

Net cash (£m) at end October 2016

78.6

Shares in issue

526.4m

Free float

34%

Code

VER

Primary exchange

AIM

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(2.2)

(17.8)

(53.3)

Rel (local)

(8.0)

(18.8)

(59.7)

52-week high/low

70.0p

32.5p

Business description

Vernalis is a UK speciality pharma company with an FDA-approved, prescription-only cough cold treatment, Tuzistra XR; an FDA-approved amoxicillin, Moxatag; and a late-stage US cough cold pipeline of four products. It also has an early- to mid-stage R&D pipeline of CNS and cancer projects. Its primary focus is on commercialising Tuzistra XR in the US.

Next events

H117 interims

March 2017

CCP-07: PDUFA date

20 April 2017

CCP-08: PDUFA date

4 August 2017

FY17 prelims

September 2017

Analysts

Lala Gregorek

+44 (0)20 3681 2527

Daniel Wilkinson

+44 (0)20 3077 5734

Vernalis is a research client of Edison Investment Research Limited

FDA acceptance of the CCP-08 NDA (setting a 4 August 2017 PDUFA date) advances Vernalis towards its goal of building a speciality US franchise of extended release (ER) prescription-only (Rx) cough cold products. Potential 2017 approval of CCP-08 and CCP-07 (PDUFA date 20 April 2017) would enable launch into the 2017/18 cough cold season. Last reported cash of £78.6m (unaudited at end October) supports ongoing investment in operational initiatives to enhance Tuzistra XR sales growth this season and beyond. Successful execution will lay important foundations for the launches of CCP-07 and CCP-08.

Year end

Revenue (£m)

PBT*
(£m)

EPS*
(p)

DPS
(p)

P/E
(x)

Yield
(%)

06/15**

19.9

(6.9)

(1.0)

0.0

N/A

N/A

06/16

12.0

(16.2)

(3.4)

0.0

N/A

N/A

06/17e

12.9

(37.6)

(6.8)

0.0

N/A

N/A

06/18e

40.7

(18.4)

(3.0)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items and share-based payments. **18-month reporting period, 12 months thereafter.

Third cough cold programme under FDA review

CCP-08 is the third of Vernalis’s cough cold products to be accepted for NDA review; this triggers a milestone payment from Vernalis to partner Tris (we assume $3m). Potential CCP-07 and CCP-08 launches into the 2017/18 cough cold season will leverage the existing Tuzistra XR salesforce and coupled to higher revenue will drive Vernalis to profitability in FY19 on our forecasts. Two other pipeline assets (CCP-05 and CCP-06) are on track for achieving proof of concept in FY17.

Progress in line with management expectations

Over Q416 Vernalis made progress with all operational priorities including improving: (1) patient access (unrestricted insurance coverage of Tuzistra XR is now c 75% of US commercial lives up from c 60%); (2) physician/brand awareness (samples shipped from October); (3) pharmacy stocking (ongoing discussions with numerous national and regional chains); and (4) territory alignment (following the 25% salesforce expansion). These activities have accelerated Tuzistra XR Rx growth, particularly over December, into a cough cold season that, like 2015/16, has started mildly (according to CDC surveillance data). Ongoing investment will underpin future sales growth, but decrease Tuzistra Rx’s net price ($/Rx) for FY17.

Valuation: DCF valuation of £377m (72p per share)

CCP-08 NDA acceptance prompts us to raise its probability of success to 90% from 75%, increasing the rNPV of CCP-08 by £11.8m (13.4p/share) to £70.7m. However, this uplift is largely offset by a lower last reported cash position (£78.6m [unaudited] at end-October vs £84m at end-June reflecting cash burn) resulting in a modestly higher company valuation of £377m or 72p/share (previously £371m or 71p/share). Our valuation consists of US cough cold and NCE pipeline rNPV, explicit cost modelling and inclusion of cash; we assume zero NPV for the research business. Upside would come from portfolio progress, launches and sales upgrades.

Exhibit 1: Financial summary

£000s

2013

2015

2016

2017e

2018e

Year end 30 June (from 2015) previously December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

14,084

19,882

12,034

12,912

40,724

of which: Cough/cold portfolio & Moxatag

0

0

1,100

4,112

31,035

Frova royalties

6,684

6,648

2,894

2,500

1,389

Collaborative income (R&D funding and milestones)

7,150

13,022

8,035

6,000

8,000

Other

250

212

5

300

300

Cost of Sales

(2,244)

(1,373)

(2,004)

(2,492)

(11,215)

Gross Profit

11,840

18,509

10,030

10,420

29,509

Sales, General & Admin

(3,299)

(8,635)

(25,717)

(38,673)

(38,943)

Research & Development

(14,416)

(22,563)

(10,932)

(10,995)

(11,105)

Other

180

611

396

0

0

Operating Profit reported

 

 

(5,695)

(11,835)

(23,572)

(39,249)

(20,539)

Intangible Amortisation

(1,349)

(571)

(713)

(1,009)

(1,765)

Exceptionals

1,608

243

2,651

0

0

Share-based payment

(876)

(1,855)

(984)

(247)

(247)

EBITDA

 

 

(4,652)

(8,855)

(23,919)

(37,692)

(18,233)

Operating Profit (norm)

 

 

(5,078)

(9,652)

(24,526)

(37,994)

(18,527)

Net Interest

420

2,733

8,315

420

175

Other financial income

(999)

(157)

(42)

0

0

Profit Before Tax (norm)

 

 

(4,658)

(6,919)

(16,211)

(37,573)

(18,351)

Profit Before Tax (as reported)

 

 

(6,274)

(9,259)

(15,299)

(38,829)

(20,363)

Tax

2,273

2,858

804

2,013

2,654

Profit from discontinued operations

0

0

0

0

0

Profit After Tax (norm)

(2,385)

(4,061)

(15,407)

(35,561)

(15,698)

Profit After Tax (as reported)

(4,001)

(6,401)

(14,495)

(36,816)

(17,710)

Average Number of Shares Outstanding (m)

442.1

442.3

449.9

526.4

526.4

EPS - normalised (p)

 

 

(0.8)

(1.0)

(3.4)

(6.8)

(3.0)

Dividend (p)

 

 

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

84.1%

93.1%

83.3%

80.7%

72.5%

EBITDA Margin (%)

-33.0%

-44.5%

-198.8%

-291.9%

-44.8%

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

-36.1%

-48.5%

-203.8%

-294.3%

-45.5%

BALANCE SHEET

Fixed Assets

 

 

7,730

15,066

19,949

33,639

37,623

Intangible Assets

6,292

12,895

17,645

31,378

35,044

Tangible Assets

1,438

1,637

1,673

1,630

1,948

Other

0

534

631

631

631

Current Assets

 

 

83,298

71,509

92,541

41,352

22,355

Stocks

130

0

233

1,366

3,072

Debtors

4,443

7,017

7,225

2,830

8,926

Cash

76,918

61,258

84,018

35,091

8,291

Other (tax and derivatives)

1,807

3,234

1,065

2,065

2,065

Current Liabilities

 

 

(4,501)

(5,215)

(7,711)

(6,781)

(9,230)

Creditors

(3,384)

(3,373)

(5,175)

(4,245)

(6,694)

Other creditors

0

(5)

(80)

0

0

Short term borrowings

0

0

0

0

0

Deferred income

(962)

(1,688)

(922)

(922)

(922)

Provisions and other current liabilities

(155)

(154)

(1,614)

(1,614)

(1,614)

Long Term Liabilities

 

 

(4,283)

(4,254)

(2,048)

(2,048)

(2,048)

Long term borrowings

0

0

0

0

0

Deferred income

(156)

(744)

(1,459)

(1,459)

(1,459)

Provisions and other long-term liabilities

(4,127)

(3,510)

(589)

(589)

(589)

Net Assets

 

 

82,244

77,106

102,731

66,162

48,699

CASH FLOW

Operating Cash Flow

 

 

(3,486)

(12,135)

(23,682)

(35,360)

(23,587)

Net Interest

446

353

230

420

175

Tax

1,929

1,887

2,912

1,013

2,654

Capex

(646)

(1,005)

(212)

(258)

(611)

Purchase of intangibles

(1,976)

(7,474)

(71)

(14,742)

(5,431)

Acquisitions/disposals

0

0

(3,677)

0

0

Financing

0

13

39,236

0

0

Dividends

0

0

0

0

0

Other

0

1,644

0

0

0

Net Cash Flow

(3,733)

(16,717)

14,736

(48,927)

(26,800)

Opening net debt/(cash)

 

 

(81,555)

(76,918)

(61,258)

(84,018)

(35,091)

HP finance leases initiated

0

0

0

0

0

Exchange rate movements

(904)

1,057

8,024

0

0

Other

0

0

0

0

0

Closing net debt/(cash)

 

 

(76,918)

(61,258)

(84,018)

(35,091)

(8,291)

Source: Edison Investment Research, Vernalis accounts. Note: 2015 was an 18-month reporting period, thereafter 12-month reporting.

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt and Sydney. 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 Vernalis 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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Germany

London +44 (0)20 3077 5700

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United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, 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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt and Sydney. 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 Vernalis 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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, 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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

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