Quantum Genomics — Strong Phase IIb data in hypertension

Quantum Genomics (PAR: ALQGC)

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Research: Healthcare

Quantum Genomics — Strong Phase IIb data in hypertension

Quantum Genomics released data from the Phase IIb NEW-HOPE trial, which strongly suggests that firibistat is an efficacious, safe drug with a differentiated mechanism that will address a very large patient population. After eight weeks of treatment, patients saw a statistically significant reduction from baseline (p<0.0001) in systolic automated office blood pressure (AOBP) of 9.7mmHg. Importantly there was no oedema that was seen with some of the other major classes of hypertension treatments.

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Written by

Healthcare

Quantum Genomics

Strong Phase IIb data in hypertension

Development update

Pharma & biotech

13 November 2018

Price

€2.40

Market cap

€29m

Net cash (€m) at 30 June 2018

5.9

Shares in issue

12.0m

Free float

84%

Code

ALQGC

Primary exchange

Euronext Paris

Secondary exchange

OTCQX

Share price performance

%

1m

3m

12m

Abs

6.2

37.9

(25.5)

Rel (local)

7.0

47.9

(21.1)

52-week high/low

€3.3

€1.7

Business description

Quantum Genomics is a biopharmaceutical company developing firibastat, a brain aminopeptidase A inhibitor for the treatment of hypertension and heart failure. Its mechanism is implicated in the 25% of patients resistant to treatment. The Phase IIb study in hypertension was recently very positive and the Phase IIb in heart failure should start by the end of 2018.

Next events

Phase IIb heart failure study initiation

Q418

Start of Phase III in hypertension

H119

Firibastat partnership

2019

Analysts

Maxim Jacobs

+1 646 653 7027

Briana Warschun

+1 646 653 7031

Quantum Genomics is a research client of Edison Investment Research Limited

Quantum Genomics released data from the Phase IIb NEW-HOPE trial, which strongly suggests that firibistat is an efficacious, safe drug with a differentiated mechanism that will address a very large patient population. After eight weeks of treatment, patients saw a statistically significant reduction from baseline (p<0.0001) in systolic automated office blood pressure (AOBP) of 9.7mmHg. Importantly there was no oedema that was seen with some of the other major classes of hypertension treatments.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/16

0.0

(6.2)

(0.60)

0.0

N/A

N/A

12/17

0.0

(10.3)

(0.93)

0.0

N/A

N/A

12/18e

0.0

(13.1)

(0.86)

0.0

N/A

N/A

12/19e

0.0

(16.2)

(1.00)

0.0

N/A

N/A

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

Efficacy similar to major blockbusters

While it is hard to compare across trials as there are differences in clinical trial design, the NEW-HOPE data is fairly similar to the eight-week treatment data for Diovan (valsartan), which had peak sales of $6bn in 2010 (although this also includes sales in heart failure patients) and had shown 6–9mmHg reductions in systolic blood pressure in their eight-week hypertension studies.

Works across races

Black people have a higher prevalence of hypertension and are less likely to have it under control compared to their white counterparts as certain classes of hypertension medication are less effective in black people. In the NEW-HOPE trial, black people saw a 10.5mmHg decrease whereas non-black people saw a 9.1mmHg decrease in systolic AOBP.

A clean safety profile

Headache was the most common treatment-emergent adverse event, seen in 3.9% of patients, followed by 2.7% with some skin issues (dermatitis, eczema). The only serious related adverse event was erythema multiforme, a skin-related hypersensitivity reaction, often caused by exposure to a particular drug. Erythema multiforme has been reported in other hypertension medications as well as in other common therapeutics such as antibiotics and aspirin.

Valuation: Increased to €803m or €66.91 per share

We have increased our valuation of Quantum Genomics from €284m or €23.71 per share to €803m or €66.91 per share, mainly due to increasing our probability of success for firibastat in hypertension from 20% to 50% due to the NEW-HOPE trial data. We also increased the probability of success in heart failure from 15% to 20% due to the innocuous safety profile so far. The probability of success for hypertension remains at a discount to where it would normally be as the company will require a partner to advance firibastat to approval.

NEW-HOPE hypertension data

The company announced the results of its NEW-HOPE study in a late-breaking presentation at the American Heart Association (AHA) annual meeting on 10 November 2018. As a reminder, the NEW-HOPE trial completed enrolment faster than expected, enrolling 256 patients (254 included in the intent-to-treat analysis) in just 10 months. NEW-HOPE focused enrolment on hypertensive overweight (BMI 25–45kg/m2) patients (65% of patients were obese), with a primary endpoint of change from baseline in systolic AOBP at week eight.

Exhibit 1: NEW-HOPE study design

Source: Quantum Genomics

Following a two-week run-in period in which there was no treatment, systolic AOBP had to be 145–170mmHg. Patients start on 250mg twice a day (BID) for two weeks and then either continue at that dose or increase to 500mg BID, if their AOBP was still higher than 140/90, for another two weeks. Following that, patients go on 250mg BID, 500mg BID or 500mg BID with 25mg of hydrochlorothiazide, an often-used diuretic, if their AOBP was higher than 160/100. Ultimately 14% of patients stayed at the 250mg BID dose, 70% of patients stayed at the 500mg BID dose and 15% had to have hydrochlorothiazide added in.

Exhibit 2: NEW-HOPE efficacy data

Baseline

Week 8

Improvement

P-value

Systolic AOBP, mean (primary endpoint, intent-to-treat analysis)

153.9

144.3

-9.7

<0.0001

Diastolic AOBP, mean (intent-to-treat analysis)

91.5

86.8

-4.5

<0.0001

Source: Quantum Genomics. Note: ND=not disclosed.

The results are quite strong and are in the vicinity of many of the standards of care (see Exhibit 3), but with a differentiated mechanism, which could be especially helpful in treating those currently not well controlled. One weakness to the data is that there was no placebo arm; however, hypertension trials typically do not have large responses with placebo patients, typically seeing declines of 2–4mmHg. Given the strength of the improvement in systolic AOBP, it is highly unlikely to be a result of a placebo response.

Exhibit 3: Competitor efficacy table

Drug

Class

Company (originator)

Peak sales (all indications)

Duration

Reduction in systolic blood pressure (mmHg)

Firibastat

BAPAI

Quantum Genomics

N/A

8 weeks

9.7

Diovan (valsartan)

ARB

Novartis

$6.0bn (2010)

8 weeks

5.6–9

Vasotec (enalapril)

ACE inhibitor

Merck

$2.5bn (1996)

4 weeks

10–14

Norvasc (amlodipine)

Calcium channel blocker

Pfizer

$4.9bn (2006)

8 weeks

12.1–16

Source: Quantum Genomics, FDA, company filings, Liu et al, (2010) Tolerability and effectiveness of (S)-amlodipine compared with racemic amlodipine in hypertension; Current therapeutic research, clinical and experimental 71, 1-29; Ruilope et al. (2010) Blood-pressure reduction with LCZ696, a novel dual-acting

inhibitor of the angiotensin II receptor and neprilysin, Lancet; 375: 1255-66.

Hypertension is one of the most common medical conditions in the industrialised world and is associated with increased risk of major cardiac events (heart attack, heart failure, aortic dissection, etc) and stroke. The age-adjusted prevalence in the US is 29% of adults,1 and between 17% and 24% in Western Europe.2 Diagnosis and treatment rates for the disease are high (83% and 76%, respectively), although the rate of control is low at only 52%.1 A large cohort of patients appears to be resistant to multiple interventions and 12–15% of diagnosed hypertensive patients are unsuccessfully controlled following treatment with three or more drugs.3 Importantly, black people have a higher prevalence of hypertension compared to other groups but, along with Hispanic people, are less likely to have their hypertension under control compared to their white counterparts.

  CDC

  Kantar Health

  Pimenta E and Calhoun DA (2012) Resistant Hypertension: Incidence, Prevalence and Prognosis. Circulation 125, 1594-1496.

Exhibit 4: Percentage of adults with hypertension who have it controlled, by race and sex

Source: Yoon S et al., NCHS Data Brief, 2015 Nov;(220):1–8

As an example, in a pre-specified subgroup analysis of the 33,357-patient ALLHAT trial, which compared the efficacy of amlodipine (a calcium channel blocker), lisinopril (an ACE inhibitor) and chlorthalidone (a diuretic), differences in efficacy between black people and non-black people were consistently seen across timepoints with differences ranging from 1.8 to 6.1mmHg.

Exhibit 5: Differences in efficacy across races for hypertension drugs

Black people

Non-black people

SBP change from baseline (mmHg)

Chlorthalidone

Amlodipine

Lisinopril

Chlorthalidone

Amlodipine

Lisinopril

1 Year

-7.7

-5.7

-2.5

-9.8

-8.4

-8.1

2 Year

-8.6

-7.1

-3.4

-10.6

-9.8

-9.5

4 Year

-10.5

-8.8

-6.8

-12.3

-12.3

-12

Source: Wright et al., Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA, April 6, 2005 – Vol. 293, No 13.

Firibastat’s efficacy in this underserved population, (10.5mmHg reduction in black people and 9.1mmHg reduction in non-black people) is helpful in setting it apart from other therapies.

Exhibit 6: Firibistat efficacy across races

Source: Quantum Genomics

Safety

Safety was innocuous and generally in line with competitors but without certain toxicities such as oedema and fatigue according to an analysis of the drug labels and FDA review documents (see Exhibit 7). Headache was the most common side effect, seen in 3.1% of patients, followed by some skin issues (dermatitis, eczema). The only serious related adverse event was erythema multiforme, a skin-related hypersensitivity reaction, often caused by exposure to a particular drug. Erythema multiforme has been reported in other hypertension medications as well as in other common therapeutics such as antibiotics and aspirin. Importantly, there were no changes in serum potassium or sodium levels observed and renal function was stable.

Exhibit 7: Competitor toxicity table

Firibastat

Norvasc

Vasotec

Diovan

Oedema

5.1%

Dizziness

2.0%*

2.6%

4%

3.6%

Flushing

1.6%

Palpitation

2.2%

Fatigue

4.5%

3%

2.1%

Nausea

2.9%

1.5%

Abdominal Pain

1.6%

Somnolence

1.4%

Headache

3.9%

5%

9.8%

Orthostatic effects

1%

Asthenia

1%

Diarrhoea

1.1%*

1%

2.1%

Cough

1%

2.3%

Rash/skin reaction

2.7%

1%

Viral infection

3.1%

Upper respiratory infection

2.5%

Rhinitis

2.0%

Sinusitis

1.9%

Back pain

1.6%

Arthralgia

1.0%

Source: FDA, *disclosed as adverse events leading to discontinuation

Valuation

We have increased our valuation of Quantum Genomics from €284m or €23.71 per share to €803m or €66.91 per share, mainly due to increasing our probability of success for firibastat for hypertension from 20% to 50% due to the NEW-HOPE trial data. We also increased the probability of success in heart failure from 15% to 20% due to the innocuous safety profile so far. The probability of success in hypertension remains at a discount to where it would normally be (for a Phase III asset we normally use a 60–70% probability of success) as the company will require a partner to advance firibastat to approval.

Exhibit 8: Quantum Genomics valuation table

Product

Main indication

Local

Status

Prob. of success

Launch year

Peak sales (m)

Patent protection

rNPV (m)

Firibastat (QGC001)

Hypertension

US

Phase Il

50%

2023

$1,110

2031

€416.15

Firibastat (QGC001)

Hypertension

Europe

Phase Il

50%

2023

$959

2031

€353.08

Firibastat (QGC001)

Development costs

 

 

 

 

-€132.33

Firibastat (QGC001)

Heart failure

US

Phase IIb

20%

2023

$574

2031

€106.26

Firibastat (QGC001)

Heart failure

Europe

Phase IIb

20%

2023

$687

2031

€126.08

Firibastat (QGC001)

Development costs

-€72.30

Total

 

 

 

 

 

 

 

€796.94

Net cash (30 June 2018) (m)

€5.91

Total firm value (m)

€802.85

Total shares (31 August 2018) (m)

12.00

Value per basic share

€66.91

Source: Edison Investment Research

Financials

The company ended H118 with €6.0m in cash and investments, adding approximately €0.7m from their €24.0m equity line from Kepler Cheuvreux during the half year. At the current run-rate, the company has stated it believes the equity line would fund it through to the end of 2020. We believe this will be dependent on whether additional trials are conducted by the company or a partner. As late-stage cardiovascular trials are extremely expensive, we expect any large Phase III trials to be financed via a partnership. However, it is possible the company may decide to at least start one of the Phase III trials as it is negotiating with potential partners to not lose any development time.

Exhibit 9: Financial summary

€000s

2016

2017

2018e

2019e

Year end 31 December

PCG

PCG

PCG

PCG

PROFIT & LOSS

Revenue

 

 

0

0

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

0

0

0

EBITDA

 

 

(6,216)

(10,292)

(12,622)

(14,792)

Operating Profit (before amort. and except.)

(6,216)

(10,292)

(12,622)

(14,792)

Intangible Amortisation

0

0

0

0

Other

1

0

4

0

Exceptionals

0

0

0

0

Operating Profit

(6,216)

(10,292)

(12,622)

(14,792)

Net Interest

0

0

(485)

(1,445)

Other

18

(176)

(61)

0

Profit Before Tax (norm)

 

 

(6,216)

(10,292)

(13,107)

(16,237)

Profit Before Tax (FRS 3)

 

 

(6,198)

(10,468)

(13,167)

(16,237)

Tax

958

1,150

1,482

2,111

Deferred tax

0

0

0

0

Profit After Tax (norm)

(5,258)

(9,142)

(11,625)

(14,126)

Profit After Tax (FRS 3)

(5,240)

(9,318)

(11,686)

(14,126)

Average Number of Shares Outstanding (m)

8.7

9.9

13.6

14.1

EPS - normalised (c)

 

 

(59.79)

(92.81)

(85.58)

(100.00)

EPS - FRS 3 (€)

 

 

(0.60)

(0.95)

(0.86)

(1.00)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

701

439

437

437

Intangible Assets

142

91

87

87

Tangible Assets

60

52

59

59

Other

500

296

292

292

Current Assets

 

 

13,809

13,478

16,421

14,295

Stocks

1,011

189

139

139

Debtors

1,599

2,197

3,127

3,127

Cash

11,198

11,089

13,155

11,029

Other

1

3

0

0

Current Liabilities

 

 

(3,481)

(4,572)

(5,759)

(5,759)

Creditors

(3,480)

(4,571)

(5,758)

(5,758)

Short term borrowings

(1)

(1)

(1)

(1)

Long Term Liabilities

 

 

(506)

(474)

(6,626)

(18,626)

Long term borrowings

(18)

(19)

(6,060)

(18,060)

Other long term liabilities

(488)

(454)

(566)

(566)

Net Assets

 

 

10,524

8,871

4,473

(9,653)

CASH FLOW

Operating Cash Flow

 

 

(5,531)

(7,977)

(9,863)

(14,112)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(66)

32

(14)

(14)

Acquisitions/disposals

0

0

0

0

Financing

7,744

7,733

6,000

0

Dividends

0

0

0

0

Other

399

104

(57)

0

Net Cash Flow

2,546

(108)

(3,934)

(14,126)

Opening net debt/(cash)

 

 

(8,573)

(11,179)

(11,069)

(7,094)

HP finance leases initiated

0

0

0

0

Exchange rate movements

0

0

0

0

Other

60

-2

-41

0

Closing net debt/(cash)

 

 

(11,179)

(11,069)

(7,094)

7,032

Source: Edison Investment Research, company reports

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. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Quantum Genomics 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 Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. 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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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. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

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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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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