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Probiodrug — Update 9 January 2017

Probiodrug — Update 9 January 2017

Probiodrug

Analyst avatar placeholder

Written by

Probiodrug

Phase IIa SAPHIR fully recruited; data in Q217

Company update

Pharma & biotech

9 January 2017

Price

€18.50

Market cap

€152m

Net cash (€m) at end Q316, incl. capital raise of €14.9m in October

26.5

Shares in issue

8.2m

Free float

50%

Code

PBD

Primary exchange

Euronext Amsterdam

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(0.5)

(8.4)

(30.2)

Rel (local)

(6.2)

(14.5)

(38.5)

52-week high/low

€26.5

€17.6

Business description

Probiodrug is a German biopharmaceutical company developing its clinical pipeline for the treatment of Alzheimer’s disease. Lead product candidate PQ912 is in Phase IIa. PQ912 is a small molecule inhibitor of glutaminyl cyclase (QC), which is essential for the formation of pGlu-Abeta. Two further products are in preclinical stages.

Next event

PQ912 Phase IIa data

Q217

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Lala Gregorek

+44 (0)20 3681 2527

Probiodrug is a research client of Edison Investment Research Limited

Probiodrug announced today that the Phase IIa trial with its lead product PQ912 is now fully enrolled with 120 patients surpassing the initial target of 110 and the data will be released in Q217. The trial is investigating the effects of first-in-class PQ912, a small molecule glutaminyl cyclase (QC) inhibitor, on Alzheimer’s disease (AD) patients. Although primarily a safety and tolerability study, a set of exploratory readouts should provide a glimpse of the effect PQ912 has on the pathology of the disease. Following the successful fundraise of €14.9m via the issue of new shares (10% of the existing) in October 2016, our valuation of Probiodrug is €337m or €41.2/share.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/14

0.0

(11.4)

(2.35)

0.0

N/A

N/A

12/15

0.0

(13.5)

(1.96)

0.0

N/A

N/A

12/16e

0.0

(14.2)

(1.82)

0.0

N/A

N/A

12/17e

0.0

(11.0)

(1.35)

0.0

N/A

N/A

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

Baseline mean MMSE indicates high quality data

Probiodrug mentioned that at baseline the mean Mini-Mental State Examination (MMSE) score of all patients was 25.3 (out maximum of 30) with low variability. Such high score implies a very mild dementia and is well in line with inclusion criteria of MMSE scores being in the range 21-30. Low variability of the scores allows us to expect high quality data and fewer outliers that can skew the findings. The final results should be reported in Q217.

Eli Lilly’s solanezumab did not meet expectations

In November 2016, Eli Lilly announced that solanezumab failed to meet the primary endpoint in the Phase III EXPEDITION3 trial with more than 2,000 mild AD patients. This was a second attempt after the failed large trial in general AD population. The primary endpoint was cognitive decline as measured by ADAS-Cog14, which came in statistically insignificant at p = 0.095. Although some of the secondary endpoints reached significance, the improvements were small and Lilly decided not to pursue the regulatory filing. While this was another blow to general beta amyloid theory, we see PQ912 as clearly differentiated with no negative read-across. Solanezumab, like many Abeta theory products, focuses on steps in the Abeta cascade, while PQ912 inhibits the production of a specific subtype of Abeta – toxic pyroglutamate-Abeta (pGlu-Abeta, more detailed analysis in our outlook report).

Valuation: €337m or €41.2/share post fundraise

Our absolute valuation of Probiodrug has increased from €309m to €337m. However, on a relative basis it remains flat at €41.2/share due to a combination of rolling our model forward, an increased cash position, but also an increased number of shares. Our product assumptions are unchanged. The outcome of the Phase IIa trial is the main catalyst in the near term.

SAPHIR trial

Probiodrug’s Phase IIa SAPHIR trial is primarily a safety and tolerability study, but the effect on the pathology of the disease will be assessed by a set of exploratory readouts comprising:

■

assessment of short-term memory and verbal function (neuropsychological test battery, NTB);

■

functional assessments by EEG and functional MRI, which will be indicative of changes in synaptic plasticity and neuronal connectivity respectively; and

■

molecular biomarkers in cerebrospinal fluid (CSF), such as pGlu-Abeta, Abeta oligomers and inflammatory markers.

More details about the trial design are provided in Exhibit 1.

Exhibit 1: SAPHIR clinical study design

Aim

To determine the safety, tolerability and preliminary efficacy of PQ912 in patients with early/mild AD. Exploratory readouts will be used to look for an efficacy signal to justify advancing to pivotal study.

Summary design

Multicentre (20 sites, seven EU countries), randomised, double-blind, placebo-controlled, parallel-group study.

Design details

n=110 planned, 120 enrolled. Treatment-naïve patients with mild cognitive impairment due to AD or mild dementia due to AD. MMSE score of 21-30 inclusive, CSF Abeta concentration of < 638 ng/L AND total tau >375 ng/L OR p-tau > 52 ng/L; Tau/Abeta ratio in CSF >0.52; positive amyloid PET if available. Half will receive PQ912, 800mg, twice a day (with an option to decrease the dose if necessary), the other half will receive placebo.

Primary endpoints

Frequency of adverse events and serious adverse events (timeframe: 12 weeks, four weeks follow-up).

Exploratory readouts

Assessments of cognitive function and change from baseline in brain functional assessments as brain functional connectivity and synaptic plasticity and molecular biomarker levels in CSF.

Start date

March 2015

Completion dates

Full results in Q217.

Source: Probiodrug, Edison Investment Research; clinicaltrials.gov. Note: MMSE = mini mental state examination.

Next steps

Probiodrug’s strategy is to establish a partnership to develop PQ912 through late stage studies. If the Phase IIa shows cognition improvements with a treatment time of just three months, in our view the company would be in an excellent position to negotiate an attractive partnership deal. Nevertheless, we believe that cognition improvement is not a prerequisite for a partnership and that a partnership will depend on the data readout. Probiodrug is the only company developing a QC inhibitor as far as we are aware, so we expect a number of players will pay close attention to the outcome of the SAPHIR trial.

Envisaging PQ912’s further development, the strategy after Phase IIa will depend on the results of the trial. Probiodrug could go directly to a pivotal Phase III study if the Phase IIa trial shows clear positive signs of PQ912 clinically improving cognition and neuronal connectivity (measured by EEG, fMRI) or molecular biomarkers. A Phase IIb study to evaluate the efficacy over a longer treatment period is another option if the exploratory readout shows a less clear signal after the three-month treatment.

Phase I details laid ground for SAPHIR

The ongoing SAPHIR study builds on the Phase I trial, which was a first-in-man, single and multiple ascending dose study that tested PQ912 in over 200 young and elderly healthy volunteers and assessed the safety, PK and PD of PQ912. Notably, this study was the first to quantify QC (enzyme that catalyses pGlu-Abeta formation) activity in human plasma and cerebrospinal fluid (CSF). The key findings include:

■

Importantly, the study established a PK/PD correlation between plasma and CSF, which allows for estimation of the target QC inhibition in CSF from blood plasma without the need for CSF collection with lumbar puncture, which requires specialist intervention.

■

Absorption was rapid with maximum plasma concentration reached in 0.5-1.5 hours. The half-life for the concentration decline from maximum concentration to 12 hours post-dose was between two and three hours, but around six hours in CSF (clinically relevant compartment) allowing for a convenient dosing for the patient, while maintaining constant inhibition of QC (the target).

■

Concentrations of PQ912 in the blood and in CSF correlated well with respective QC inhibition. The CSF QC inhibition was estimated at 70% after dosing of 400mg (received in two doses daily) and 90% at 800mg, therefore the latter was selected for the Phase IIa study.

■

PQ912 was safe and well tolerated with most adverse events mild or moderate (GI symptoms, headache) and the maximum tolerated dose was not reached.

Financials

Our operational forecasts remain unchanged and we have only amended the financials to reflect the recent equity fundraise. We estimated FY16 R&D costs at €11.1m (€10.2m in 2015) and G&A at €3.3m (flat y-o-y). In October 2016, Probiodrug raised €14.9m gross by issuing new shares (10% of the existing) at €20.00, while the cash position was €11.6m at the end of Q316 (Probiodrug has no debt). The existing cash is sufficient to reach the data readout from the SAPHIR trial. We continue to expect that if the trial results are positive a licensing deal in 2017 is likely given the high profile of Probiodrug’s R&D programme among the larger players in the AD field. Although our valuation includes risk-adjusted milestones from a partner for PQ912 that could be triggered by licensing (more details in our initiation report), we do not include this in our financial forecasts in line with our research principles. Our valuation currently includes a risk-adjusted €25m in potential upfront payments in 2017 upon licensing, which could secure the company’s operations without the need for a further fundraising in the near term.

Exhibit 2: Financial summary

€'000s

2012

2013

2014

2015

2016e

2017e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

6

0

0

0

0

0

Cost of Sales

0

0

0

0

0

0

Gross Profit

6

0

0

0

0

0

Research and development

(9,255)

(8,004)

(8,008)

(10,158)

(11,105)

(7,669)

EBITDA

 

 

(10,206)

(9,387)

(11,173)

(13,337)

(14,285)

(11,018)

Operating Profit (before amort. and except.)

(10,521)

(9,675)

(11,241)

(13,363)

(14,311)

(11,044)

Intangible Amortisation

(37)

(26)

(26)

(30)

(30)

(26)

Exceptionals

0

0

0

0

0

0

Other

0

0

0

0

0

0

Operating Profit

(10,558)

(9,701)

(11,267)

(13,393)

(14,342)

(11,070)

Net Interest

(314)

(106)

(170)

(112)

122

17

Profit Before Tax (norm)

 

 

(10,835)

(9,781)

(11,411)

(13,475)

(14,190)

(11,027)

Profit Before Tax (FRS 3)

 

 

(10,872)

(9,807)

(11,437)

(13,505)

(14,220)

(11,053)

Tax

(656)

0

0

0

0

0

Profit After Tax (norm)

(11,491)

(9,781)

(11,411)

(13,475)

(14,190)

(11,027)

Profit After Tax (FRS 3)

(11,528)

(9,807)

(11,437)

(13,505)

(14,220)

(11,053)

Average Number of Shares Outstanding (m)

4.1

4.3

4.9

6.9

7.8

8.2

EPS - normalised (EUR)

 

 

(2.84)

(2.30)

(2.35)

(1.96)

(1.82)

(1.35)

EPS - normalised and fully diluted (EUR)

 

(2.84)

(2.30)

(2.35)

(1.96)

(1.82)

(1.35)

EPS - (IFRS) (EUR)

 

 

(2.85)

(2.30)

(2.35)

(1.97)

(1.82)

(1.35)

Dividend per share (EUR)

0.0

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

n/a

n/a

n/a

n/a

n/a

EBITDA Margin (%)

n/m

n/a

n/a

n/a

n/a

n/a

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

n/m

n/a

n/a

n/a

n/a

n/a

BALANCE SHEET

Fixed Assets

 

 

996

425

186

140

84

32

Intangible Assets

67

101

82

56

26

0

Tangible Assets

926

321

101

81

55

29

Investments

3

3

3

3

3

3

Current Assets

 

 

9,009

5,856

21,294

21,726

23,156

12,806

Stocks

18

0

0

0

422

422

Debtors

5

0

0

0

0

0

Cash

7,726

4,421

20,920

21,361

22,369

12,019

Other

1,260

1,435

374

365

365

365

Current Liabilities

 

 

(3,570)

(9,320)

(4,580)

(4,911)

(4,656)

(4,343)

Creditors

(3,570)

(3,974)

(4,580)

(4,911)

(4,656)

(4,343)

Short term borrowings

0

(5,346)

0

0

0

0

Long Term Liabilities

 

 

(1,070)

(1,265)

(929)

(822)

(822)

(822)

Long term borrowings

0

0

0

0

0

0

Other long term liabilities

(1,070)

(1,265)

(929)

(822)

(822)

(822)

Net Assets

 

 

5,365

(4,304)

15,971

16,133

17,762

7,673

CASH FLOW

Operating Cash Flow

 

 

(12,090)

(8,477)

(10,540)

(12,149)

(13,998)

(10,367)

Net Interest

22

9

(54)

0

122

17

Tax

28

9

5

2

0

0

Capex

(64)

(4)

(2)

(6)

0

0

Acquisitions/disposals

0

0

0

0

0

0

Financing

9,516

(188)

32,436

12,594

14,885

0

Dividends

0

0

0

0

0

0

Net Cash Flow

(2,588)

(8,651)

21,845

441

1,008

(10,351)

Opening net debt/(cash)

 

 

(10,314)

(7,726)

925

(20,920)

(21,361)

(22,369)

HP finance leases initiated

0

0

0

0

0

0

Other

0

0

0

(0)

(0)

0

Closing net debt/(cash)

 

 

(7,726)

925

(20,920)

(21,361)

(22,369)

(12,019)

Source: Probiodrug 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 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 Probiodrug 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

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 Probiodrug 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

Lifewatch — Update 9 January 2017

Lifewatch

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