Q3 results

Photocure 21 November 2016 Update

Photocure

Q3 results

Earnings update

Pharma & biotech

21 November 2016

Price

NOK39.60

Market cap

NOK851m

NOK8.50/US$

Net cash (NOKm) at 30 September 2016

94

Shares in issue

21.5m

Free float

88%

Code

PHO

Primary exchange

Oslo

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

1.5

(24.9)

10.9

Rel (local)

(0.3)

(29.1)

12.3

52-week high/low

NOK54

NOK33

Business description

Photocure specialises in photodynamic therapy. Its bladder cancer imaging product is sold as Hexvix in Europe and Cysview in the US. Photocure handles the marketing in Nordic countries and the US, while Ipsen is its marketing partner in the EU. Cevira is a Phase III-ready product for HPV-related diseases of the cervix and Visonac is a Phase III-ready product for acne.

Next events

Complete enrolment in Hexvix/Cysview surveillance trial

Q416

Surveillance trial results

2017

Partnerships for Cevira and Visonac

2017

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Photocure is a research client of Edison Investment Research Limited

Photocure announced Q3 sales of Hexvix/Cysview of NOK31.6m, which although a 17% increase year-on-year (13% in constant currency) represents a 7% sequential reduction in sales. This is largely attributable to seasonality although unit sales in Nordic countries were 14% lower as a result of salesforce staffing issues. US sales continue to be a growth driver with 10% sequential growth and 46% growth year-on-year.

Year end

Revenue (NOKm)

PBT*
(NOKm)

EPS*
(NOK)

DPS
(NOK)

P/E
(x)

Yield
(%)

12/14

129.0

1.5

0.07

0.0

N/A

N/A

12/15

134.7

(17.4)

(0.82)

0.0

N/A

N/A

12/16e

134.9

(22.0)

(1.02)

0.0

N/A

N/A

12/17e

150.4

(16.1)

(0.74)

0.0

N/A

N/A

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

US sales supported by broader uptake

Photocure announced that the total number of blue cystoscopes in the US increased to 81, two more than last quarter and 16 more for the year. Demand for Hexvix/Cysview remains strong in the region at 8% growth in unit sales quarter-over-quarter, which is the strongest in the year-to-date.

New publications bolster Hexvix/Cysview case

The adoption of the technology has been supported by recent publications detailing the utility of Hexvix/Cysview. A new meta-analysis details the lower risk of progression with patients following blue-light cystoscopy (odds ratio 1.68, p=0.01). A second paper on a German clinical trial (n=403) investigated the increased ability to find lesions using the technology and found a 6.8% increase in cancers and a 25% increase in carcinoma in situ were found (p<0.0001).

Overseas partnerships underway

Photocure has partnered with Juno in Australia and New Zealand, and with BioSyent in Canada for the commercialisation of Hexvix/Cysview. Adoption has been slow in Canada because of the low number of placements of blue-light cystoscopes. However, the product was recently approved in Australia, triggering a NOK2.3m milestone, and sales should be commencing soon.

Valuation: NOK1,490m or NOK69 per share

We have increased our valuation slightly to NOK1,490m or NOK69 per share, from NOK1,455m or NOK68 per share. The reduction in cash to NOK94m was offset by increases in the value of Cevira and Visonac associated with rolling forward our NPVs. We expect to update our valuation following the results from the Hexvix/Cysview Phase III trial and any partnership announcements for Cevira and Visonac.

A slow quarter: Seasonality and salesforce issues

Photocure is a pharmaceutical and diagnostic company that has developed and commercialised the photoactive compound hexaminolevulinate hydrochloride (HAL) for the detection of bladder cancer and currently markets the product in Europe as Hexvix and in North America as Cysview. The product is selectively metabolised in bladder cancer cells forming a fluorescent product that is visible using blue-light cystoscopy, which enables the doctor to more reliably resect the affected tissue. The company has internally commercialised Hexvix/Cysview in its home Nordic territory and in the United States, and it is licensed to partners in Europe, Canada, Australia, and New Zealand.

Photocure is also developing Cevira, a drug/device combination for the treatment of HPV-related dysplasias of the cervix using the same light sensitive molecule as Hexvix/Cysview and an intravaginal light device. The treatment successfully demonstrated efficacy controlling high-grade squamous intraepithelial lesions, and is currently Phase III-ready, pending Photocure finding a development partner. Visonac is a treatment for acne in development at Photocure, which could potentially be used in patients who are refractory to other treatments. It is similarly Phase III-ready pending a partnership.

Q316 results: Positive momentum in the US

Photocure recently reported sales of NOK31.6m for Q316. This marks a year-on-year growth of 17% (13% in constant currency), primarily driven by expansion of the US market, which expanded to NOK7.8m, with 46% growth year-on-year and 10% sequentially. A total of 81 blue-light cystoscopes have been placed in the US, an increase of two from the previous quarter and 16 for the year. Demand remains on an upward trajectory in the US, with unit sales up 37% year-on-year and 8% sequentially. One of the driving factors for increased adoption is the more widespread acceptance of the benefits of blue-light cystoscopy to patients. In May the procedure was added to the guidelines for management of non-muscle invasive bladder cancer by the American Urological Association and the Society of Urologic Oncology. This opinion has been backed up by the recent publication of a meta-analysis supporting the conclusion that the product reduces the rate of cancer progression (odds ratio of 1.64, p=0.01)1 and a recent German clinical trial (n=403) showing that Hexvix/Cysview can increase the number of detected lesions (6.8% for cancer and 25% for carcinoma in situ, p<0.0001).2

  Gakis G, Fahmy O (2016) Systematic Review and Meta-Analysis on the Impact of Hexaminolevulinate- Versus White-Light Guided Transurethral Bladder Tumor Resection on Progression in Non-Muscle Invasive Bladder Cancer. Blad. Cancer 2, 293-300.

  Back T, et al. (2016) Optimised photodynamic diagnosis for transurethral resection of the bladder (TURB) in German clinical practice: results of the noninterventional study OPTIC III. World J. Urol. ePub.

In Nordic territories, Q3 has historically been a slow quarter (as is Q1) due to seasonality effects. Consistent with this, sales for Q3 were down 18% sequentially, but sales increased 7% year-on-year. However, the growth was primarily driven by favourable exchange rate effects. Unit sales for the region were down 14% year-on-year in all countries, which the company attributes to vacancies in its salesforce.

Exhibit 1: Hexvix/Cysview Q3 sales

Sales (NOKm)

Y-o-y

Q-o-q

Units

Y-o-y

Q-o-q

Hexvix sales Nordic

8,720

7%

-18%

1,984

-14%

-14%

Cysview sales US

7,782

46%

10%

1,080

37%

8%

Total own sales

16,502

22%

-7%

3,064

-1%

-8%

Partner sales

15,138

12%

-8%

10,274

4%

-11%

Total Hexvix/Cysview

31,639

17%

-7%

13,338

3%

-10%

Source: Photocure

Exhibit 2: Hexvix/Cysview internal sales

Source: Photocure

Partner sales for the quarter were NOK15.1m, which is a 12% increase over 2015, although these sales have a degree of unpredictability based on the partners’ purchasing schedules. End user sales by partners increased 4% over 2015. This is a slowdown from the 7% increase in end user sales in Q216 and 5% for the year to date. The company recently expanded its partners by licensing Hexvix/Cysview to BioSyent in Canada and Juno Pharmaceuticals in Australia and New Zealand. Initial sales in Canada have been hampered by the limited number of blue-light cystoscopes in the country and a slower than anticipated placement of the devices. Marketing authorisation was just recently obtained in Australia in Q3, which triggered a NOK2.3m milestone payment.

Total revenue for the quarter was NOK35.2, with an operating loss of NOK3.2m. Spending was similar to previous quarters at NOK36.3m. We have slightly increased our 2016 predicted revenue to NOK135m from NOK133m to reflect the Juno milestone, and we have slightly reduced COGS to reflect the current run rate (NOK9.1m from NOK9.7m). The company ended Q3 with NOK94m, which should be supplemented by the final €4m payment for Galderma in Q4. We expect this cash to be sufficient for the company to reach profitability in 2018, contingent on the expansion of the Hexvix/Cysview indication to include the surveillance market following the results of the ongoing Phase III clinical trial. The company has guided to lower spending on the trial (€2.5m in 2016 and €7.5m total compared to €3.5m and €8.5m). Enrolment is expected to be complete in Q4 and results are expected in 2017.


Valuation

We have increased our valuation slightly to NOK1,490m or NOK69 per share, from NOK1,455m or NOK68 per share. The reduction in cash was offset by an increase in the value of the Cevira and Visonac assets associated with advancing our NPVs. Our model assumes a partnership agreement will be made for these assets in 2017 with associated milestones of NOK80m each. We expect to update our valuation with any announcement of partnerships and following the results of the Hexvix/Cysview Phase III clinical trial.

Exhibit 3: Photocure valuation

Product

Main indication

Status

Probability of commercialisation

Launch year

Peak sales (NOKm)

Patent protection

Economics

rNPV (NOKm)

Hexvix/Cysview

Bladder cancer detection

Market

100%

Launched

332

2019-20

Fully owned – US and Nordics, partner with Ipsen in EU (35% royalty)

553

Cevira

HPV-related diseases

Phase III

50%

2020

2,399

2030

17.5%

395

Visonac

Acne

Phase III

60%

2020

2,175

2028

17.5%

449

Total

 

 

 

 

 

 

 

1,396

Cash and cash equivalents (Q316)

94

Total firm value

1,490

Total basic shares (m)

21.5

Value per basic share (NOK)

69

Options (Q316, m)

0.2

Total number of shares (m)

21.7

Diluted value per share (NOK)

69

Source: Edison Investment Research

Exhibit 4: Financial summary

NOK000s

2014

2015

2016e

2017e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

128,951

134,717

134,861

150,404

Cost of Sales

(6,996)

(8,221)

(9,094)

(11,662)

Gross Profit

121,955

126,496

125,767

138,741

Sales, General and Administrative Expenses

(93,576)

(115,025)

(126,528)

(132,854)

Research and Development Expense

(32,540)

(29,558)

(15,985)

(16,785)

EBITDA

 

 

(4,161)

(18,087)

(16,746)

(10,897)

Operating Profit (before GW and except.)

(5,630)

(21,986)

(23,160)

(17,311)

Intangible Amortisation

0

0

0

0

Other

0

0

0

0

Exceptionals

0

0

0

0

Operating Profit

(5,630)

(21,986)

(23,160)

(17,311)

Net Interest

7,157

4,553

1,187

1,234

Other

(15,573)

(9,771)

224

0

Profit Before Tax (norm)

 

 

1,527

(17,434)

(21,973)

(16,077)

Profit Before Tax (FRS 3)

 

 

(14,046)

(27,205)

(21,748)

(16,077)

Tax

(0)

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

1,527

(17,434)

(21,973)

(16,077)

Profit After Tax (FRS 3)

(14,046)

(27,205)

(21,748)

(16,077)

Average Number of Shares Outstanding (m)

21.3

21.4

21.5

21.7

EPS - normalised fully diluted (øre)

 

 

7

(82)

(102)

(74)

EPS - FRS 3 (øre)

 

 

(66)

(127)

(101)

(74)

Dividend per share (NOK)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

76,512

76,394

90,878

113,619

Intangible Assets

42,393

50,615

37,017

60,025

Tangible Assets

3,056

2,288

1,654

1,387

Other

31,063

23,490

52,207

52,207

Current Assets

 

 

194,067

171,670

151,499

130,103

Stocks

13,237

13,800

15,353

17,363

Debtors

15,585

23,844

20,476

23,156

Cash

165,245

134,026

102,710

76,623

Other

0

0

12,960

12,960

Current Liabilities

 

 

(27,466)

(34,039)

(30,402)

(30,402)

Creditors

(27,466)

(34,039)

(30,402)

(30,402)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

(3,055)

(3,960)

(4,356)

(4,792)

Long term borrowings

0

0

0

0

Other long term liabilities

(3,055)

(3,960)

(4,356)

(4,792)

Net Assets

 

 

240,058

210,064

207,618

208,528

CASH FLOW

Operating Cash Flow

 

 

(6,089)

(21,030)

(11,615)

2,283

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(748)

(14,930)

(23,825)

(30,888)

Acquisitions/disposals

0

0

0

0

Financing

0

0

0

0

Dividends

0

0

0

0

Other

4,138

2,326

2,421

2,518

Net Cash Flow

(2,699)

(33,634)

(33,019)

(26,087)

Opening net debt/(cash)

 

 

(167,258)

(165,245)

(134,026)

(102,710)

HP finance leases initiated

0

0

0

0

Exchange rate movements

(1)

2

0

0

Other

687

2,413

1,703

0

Closing net debt/(cash)

 

 

(165,245)

(134,026)

(101,710)

(76,623)

Source: Photocure accounts, Edison Investment Research

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, Sydney and Wellington. 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 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Photocure 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 2016. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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Edison, 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, Sydney and Wellington. 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 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Photocure 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.
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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

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

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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