Immunovia — Final top-line IMMray data in Lupus, FY16 results

Immunovia — Final top-line IMMray data in Lupus, FY16 results

Immunovia has announced final top-line data of the IMMray platform from a retrospective study in autoimmune diseases. The study showed that the IMMray biomarker platform could differentiate blood samples from patients with systemic lupus erythematosus (SLE) from other autoimmune diseases with 96% accuracy. This is an important first step to show the versatility and potential expansion of the IMMray technology to other indications. Immunovia’s main focus continues to be pancreatic cancer in high-risk individuals and newly diagnosed diabetic patients. Additionally, the company has reported full year 2016 financial results. Cash at end 2016 was SEK259m; we have updated our valuation to SEK151 per share.

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Immunovia

Final top-line IMMray data in Lupus, FY16 results

Company update

Healthcare equipment
& services

30 March 2017

Price

SEK102.50

Market cap

SEK1,722m

US$0.11/SEK

Net cash (SEKm) at end 2016

259

Shares in issue

16.8m

Free float

64%

Code

IMMUNOV

Primary exchange

NASDAQ FN Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(3.3)

12.3

91.6

Rel (local)

(3.8)

7.2

63.2

52-week high/low

SEK119.0

SEK44.0

Business description

Immunovia is a Swedish diagnostics company based in Lund’s Medicon Village. It specialises in diagnostics for oncology and autoimmune diseases. Its main product is IMMray PanCan-d, an antibody microarray based on its proprietary IMMray platform. A prospective trial in high-risk patients has started. The company expects to generate initial out-of-pocket sales in 2018.

Next events

Commence commercial operations

2017

First revenues

2018

Complete prospective trial, registration

2019

Analysts

Juan Pedro Serrate

+44 (0)20 3681 2534

Jonas Peciulis

+44 (0)20 3077 5728

Immunovia is a research client of Edison Investment Research Limited

Immunovia has announced final top-line data of the IMMray platform from a retrospective study in autoimmune diseases. The study showed that the IMMray biomarker platform could differentiate blood samples from patients with systemic lupus erythematosus (SLE) from other autoimmune diseases with 96% accuracy. This is an important first step to show the versatility and potential expansion of the IMMray technology to other indications. Immunovia’s main focus continues to be pancreatic cancer in high-risk individuals and newly diagnosed diabetic patients. Additionally, the company has reported full year 2016 financial results. Cash at end 2016 was SEK259m; we have updated our valuation to SEK151 per share.

Year
end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/15

17.0

(7.38)

(0.65)

0.0

N/A

N/A

12/16

24.5

(14.72)

(0.98)

0.0

N/A

N/A

12/17e

27.8

(17.55)

(1.04)

0.0

N/A

N/A

12/18e

43.6

(30.80)

(1.83)

0.0

N/A

N/A

Note: *Normalised, excluding amortisation of acquired intangibles and exceptionals.

IMMray shows potential in autoimmune diseases

Immunovia has reported the final top-line data from its IMMray biomarker microarray in autoimmune diseases. In particular, data from a retrospective trial in 315 blood samples designed to assess IMMray SLE biomarker signature showed that IMMray can differentiate samples with SLE from other diseases such as rheumatoid arthritis, vasculitis and Sjögren’s syndrome with 96% accuracy. The data are relevant as up to half of SLE cases are usually misdiagnosed, according to Immunovia. Furthermore, these data support further development of IMMray in autoimmune diseases, representing potential upside. We believe that Immunovia will now seek to conduct further validation studies, including in prospective trials.

Pancreatic cancer remains the focus

Immunovia continues the development of IMMray PanCan-d for the early diagnosis of pancreatic cancer. A prospective clinical trial (PANFAM-I) started in December 2016 in high-risk individuals. The study will run for three years and recruit 1,000 patients. We estimate this could be a SEK2bn opportunity. Additionally, the company signed a memorandum of understanding with the US National Cancer Institute (NCI) to validate biomarkers in patients over 50 years of age diagnosed with diabetes. This could lead to a consortium that would test samples from 10,000 patients over three years. We believe this could represent an opportunity of SEK34bn.

Valuation: Updated rNPV of SEK151/share

We are updating our valuation to SEK151 per share (vs SEK155 per share), mainly for the FY16 net cash position of SEK259m and our expenses forecast. The rest of our assumptions remain the same: we assume a penetration rate of 35% in patients at high risk of pancreatic cancer and 5% in newly diagnosed diabetic patients, targeting total peak sales of c SEK2.1bn in both groups. We look to include SLE in our valuation when Immunovia discloses its plans for this indication.

Financials

Total operating expenses increased to SEK39.4m in FY16 from SEK24.4m in FY15, mainly due to increased headcount (21 employees at end 2016 vs 14 at end 2015), an uptick in R&D spend (SEK24.3m in FY16 compared to SEK16.8m in FY15), and marketing activities. This is above our estimate of SEK34.9m. From 2017 to 2020 we expect Immunovia to fund a prospective clinical trial in individuals at high risk of pancreatic cancer (at an estimated cost of SEK40m over three years) and a trial in newly diagnosed type 2 diabetes (T2D) patients (at an estimated cost of SEK90m for three years). Therefore, we are raising our total expense forecasts to SEK46.0m in 2017 and SEK68.3m in 2018 (vs previous SEK33.4m and SEK59.3m respectively).

Immunovia’s end of 2016 cash position was SEK259.1m, which includes the capital raise of c SEK218.6m during Q416. We estimate this be should be sufficient to fund operations for the next three years, including the initiation of clinical trials as well as commercial activities; and we expect Immunovia to achieve positive operating cash flow in 2020.

Valuation

We update our valuation to SEK151 per share (SEK145/share fully diluted), with a 12.5% discount rate. The slight decrease with respect to our previous valuation of SEK155.2/share is related to updated net cash of SEK259m (down from SEK274m previously) and our increased expenses forecast for the period 2017-20. We have two valuation scenarios:

Scenario 1 (SEK151/share): we assume the test is reimbursed for the diabetes group and garners a 5% market share. This group is a potential population of 3.4 million new patients per year, which is 6.8m tests and represents a total market opportunity of SEK34bn at SEK5,000/test. Peak sales in 2028 are SEK1.4bn. We also include the high-risk pancreatic cancer group, which represents 200,000 potential patients. We project peak sales in 2025 of SEK707m at SEK5,000 per test and 35% market share in Europe and US, used twice a year.

Scenario 2 (SEK77/share): if the test is not reimbursed for diabetic patients, we project a 1% market share. Peak sales in this case would be SEK275m in 2028. The high-risk pancreatic cancer group assumptions remain unchanged.

We will include SLE in our valuation when the company discloses its plans for this indication.

Exhibit 1: Valuation summary

Scenario 1

Scenario 2

US$m

SEKm

US$m

SEKm

Peak sales in T2D patients (US and EU in 2028)

151

1,373

30

275

Peak sales in at risk patients (US and EU in 2025)

78

707

78

707

PV of explicit FCF forecast (2017-2028)

104.4

949

42.4

386

Terminal value (2.5% TGR)

599.3

5,448

294.3

2,675

PV of terminal value

145.8

1,326

71.6

651

Total NPV

250.2

2,274.6

114

1,036.6

Add net cash (FY16e)

28.5

259.1

28.5

259.1

Implied equity value

278.7

2,533.7

142.5

1,295.7

Number of shares (m)

16.8

16.8

16.8

16.8

Per basic share

$16.6/share

SEK150.8/share

$8.5/share

SEK77.1/share

Source: Edison Investment Research. Note: Exchange rate US$0.11/SEK.

Exhibit 2: Financial summary

SEK000s

2013

2014

2015

2016

2017e

2018e

Year end 31 December

GAAP

GAAP

GAAP

GAAP

GAAP

GAAP

PROFIT & LOSS

Revenue (includes capitalised work)

1,180

534

17,007

24,503

27,803

43,609

Cost of Sales

0

0

0

0

0

(6,611)

Gross Profit

1,180

534

17,007

24,503

27,803

36,999

Operating expenses

(1,875)

(7,549)

(17,377)

(24,115)

(23,333)

(43,333)

Personnel

(417)

(1,382)

(6,749)

(14,815)

(22,223)

(24,005)

EBITDA

 

 

(1,114)

(8,701)

(7,136)

(14,429)

(17,753)

(30,340)

Operating Profit (before GW and except.)

(1,614)

(8,960)

(7,424)

(14,978)

(18,202)

(31,332)

Intangible Amortisation

0

0

0

0

0

0

Exceptionals/Other

0

0

0

0

0

0

Operating Profit

(1,614)

(8,960)

(7,424)

(14,978)

(18,202)

(31,332)

Net Interest

17

101

40

255

648

529

Exceptionals/Other

0

0

0

0

0

0

Profit Before Tax (norm)

 

 

(1,596)

(8,859)

(7,384)

(14,723)

(17,554)

(30,803)

Profit Before Tax (IFRS)

 

 

(1,596)

(8,859)

(7,384)

(14,723)

(17,554)

(30,803)

Tax

0

0

0

0

0

0

Discontinued operations

0

0

0

0

0

0

Profit After Tax (norm)

(1,596)

(8,859)

(7,384)

(14,723)

(17,554)

(30,803)

Profit After Tax (IFRS)

(1,596)

(8,859)

(7,384)

(14,723)

(17,554)

(30,803)

Average Number of Shares Outstanding (m)

6.24

11.05

11.42

14.99

16.80

16.80

EPS - normalised (ore)

 

 

(26)

(80)

(65)

(98)

(104)

(183)

EPS - IFRS (SEK)

 

 

(0.26)

(0.80)

(0.65)

(0.98)

(1.04)

(1.83)

Dividend per share (SEK)

0.00

0.00

0.00

0.00

0.00

0.00

Gross Margin (%)

N/A

N/A

N/A

N/A

N/A

N/A

EBITDA Margin (%)

N/A

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

N/A

BALANCE SHEET

Fixed Assets

 

 

3,596

6,209

14,556

22,485

49,639

82,811

Intangible Assets

3,596

5,469

13,885

19,483

46,637

79,809

Tangible Assets

0

740

671

3,002

3,002

3,002

Other

0

0

0

0

0

0

Current Assets

 

 

3,869

32,664

76,959

260,925

214,939

147,446

Stocks

0

0

0

0

1,050

1,322

Debtors

228

464

814

1,830

1,830

1,889

Cash

3,607

31,804

75,767

259,095

211,763

143,939

Other

34

396

378

0

296

296

Current Liabilities

 

 

(2,526)

(3,131)

(7,713)

(6,778)

(5,500)

(1,983)

Creditors

(969)

(1,164)

(1,252)

0

0

(1,983)

Short term borrowings

0

0

0

0

0

0

Deferred revenues

0

0

0

0

0

0

Other short term liabilities

(1,557)

(1,967)

(6,461)

(6,778)

(5,500)

0

Long term liabilities

 

 

0

0

0

0

0

0

Long term borrowings

0

0

0

0

0

0

Deferred revenues

0

0

0

0

0

0

Other long term liabilities

0

0

0

0

0

0

Net Assets

 

 

4,939

35,742

83,802

276,632

259,078

228,274

CASH FLOW

Operating Cash Flow

 

 

(1,111)

(8,291)

(2,844)

(11,868)

(19,729)

(33,658)

Net Interest

0

0

0

0

0

0

Tax

0

0

0

0

0

0

Capex

0

(3,175)

(8,636)

(30,809)

(27,603)

(34,166)

Acquisitions/disposals

0

0

0

0

0

0

Financing

4,042

39,663

55,441

207,233

0

0

Dividends

0

0

0

0

0

0

Other

(17)

0

0

18,772

0

0

Net Cash Flow

2,914

28,197

43,961

183,328

(47,332)

(67,824)

Opening net debt/(cash)

 

 

(693)

(3,607)

(31,804)

(75,767)

(259,095)

(211,763)

HP finance leases initiated

0

0

0

0

0

0

Exchange rate movements

0

0

0

0

0

0

Other

0

0

1

0

0

0

Closing net debt/(cash)

 

 

(3,607)

(31,804)

(75,767)

(259,095)

(211,763)

(143,939)

Source: Immunovia accounts, Edison Investment Research. Note: Revenues now include net sales (royalty income), capitalised work and other income; previously we only displayed net sales.

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 Immunovia 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 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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 Immunovia 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 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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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