AlzeCure Pharma — Catalysts on the horizon

AlzeCure Pharma (Stockholm: ALZCUR)

Last close As at 27/03/2024

5.10

−0.18 (−3.41%)

Market capitalisation

SEK268m

More on this equity

Research: Healthcare

AlzeCure Pharma — Catalysts on the horizon

AlzeCure remains on track with its evolution into a mid-stage biotech, having recently reported positive headline data from its Phase Ib trial for ACD440, topical TRPV1 antagonist for pain. The company also held an R&D event for its Painless platform highlighting assets for pain ACD440 and TrkA-NAM (preclinical). Upcoming Phase I data for ACD856, a cognitive enhancer for Alzheimer’s disease (AD), are expected in the coming months, while details about the start of a Phase IIa trial with ACD440 should be clarified later this year. We value AlzeCure at SEK826m or SEK21.9 per share (vs SEK19.3 per share previously).

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Written by

Healthcare

AlzeCure Pharma

Catalysts on the horizon

R&D update

Pharma & biotech

1 June 2021

Price

SEK7.77

Market cap

SEK294m

Net cash (SEKm) at end-Q121

94.2

Shares in issue

37.8m

Free float

63%

Code

ALZCUR

Primary exchange

Nasdaq First North Growth

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

6.4

3.5

35.5

Rel (local)

7.3

(7.6)

(6.7)

52-week high/low

SEK11.60

SEK5.30

Business description

AlzeCure Pharma is a clinical-stage biotech company based in Sweden focused on developing small molecule drugs for the treatment of Alzheimer’s (symptomatic and disease modifying) and pain (neuropathic and osteoarthritic).

Next events

PDUFA date for aducanumab

7 June 2021

ACD856 Phase I SAD data

Mid-2021

Filing for Phase IIa ACD440 study

H221

Analysts

Dr Jonas Peciulis

+44 (0)20 3077 5728

Dr Sean Conroy

+44 (0)20 3077 5700

AlzeCure Pharma is a research client of Edison Investment Research Limited

AlzeCure remains on track with its evolution into a mid-stage biotech, having recently reported positive headline data from its Phase Ib trial for ACD440, topical TRPV1 antagonist for pain. The company also held an R&D event for its Painless platform highlighting assets for pain ACD440 and TrkA-NAM (preclinical). Upcoming Phase I data for ACD856, a cognitive enhancer for Alzheimer’s disease (AD), are expected in the coming months, while details about the start of a Phase IIa trial with ACD440 should be clarified later this year. We value AlzeCure at SEK826m or SEK21.9 per share (vs SEK19.3 per share previously).

Year end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/19

0.0

(50.9)

(1.35)

0.0

N/A

N/A

12/20

0.0

(71.4)

(1.89)

0.0

N/A

N/A

12/21e

0.0

(82.0)

(2.17)

0.0

N/A

N/A

12/22e

0.0

(86.1)

(2.28)

0.0

N/A

N/A

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

Positive Phase Ib data for ACD440

In April 2021, AlzeCure announced headline findings from its placebo-controlled, Phase Ib study (n=24) with ACD440 in healthy volunteers. The drug candidate was well tolerated and demonstrated an initial signal of analgesic potential (statistically significant effect compared to placebo). Full results are due to be presented at the upcoming IASP World Congress on Pain in June 2021, but the company has already indicated that the data allow planning the next study. We expect an update on the details of trial design and timelines during H221.

Data from Phase I with ACD856 in AD imminent

Phase I results for ACD856 are expected in the coming months and should provide initial safety and tolerability data from the single ascending dose part of the study. The results from the multiple ascending dose part of the study will follow thereafter, while an extension phase is expected to investigate early cognitive effects of ACD856, with data expected sometime in 2022. We also note the upcoming FDA decision (7 June) on whether to approve Biogen’s AD drug candidate aducanumab is a key near-term catalyst for the stock and for the AD drug development industry in general. Both AlzeCure’s platforms in AD are differentiated from Biogen’s antibody approach, so the direct read across is limited. However, this will be a landmark event in AD research, so there should a sentiment effect either way for all players in the AD area.

Valuation: SEK826m or SEK21.9 per share

Our risk-adjusted NPV for AlzeCure is now SEK826m or SEK21.9 per share (from SEK729m or SEK19.3 per share) as we have increased our probability of success for ACD440 to 20% from 10%, given management’s guidance it will progress to the next trial (Phase II). AlzeCure had cash of SEK94.2m at the end of Q121, which should provide funding into 2022. The next catalysts are the data from the Phase I study with ACD856 and aducanumab’s PDUFA date.

Painless platform R&D event: Key takeaways

AlzeCure’s Painless platform currently consists of in-licensed asset ACD440, which is being developed as a topical treatment for neuropathic pain (Phase Ib), and TrkA-NAM for osteoarthritic pain (early preclinical). Non-opioid based analgesics complement and diversify AlzeCure’s R&D pipeline well, in our view, which also includes two other platforms focused on AD (for detailed analysis, please see our recent initiation report).

On 11 May 2021, the company held an R&D event, where it presented ACD440 and TrkA-NAM in detail. Areas of specific interest for us included an update on the upcoming Phase IIa study of ACD440; and a detailed introduction to the novel mechanism of action of TrkA-NAM by AlzeCure’s Head of Discovery and Research Pontus Forsell. In the past, AlzeCure had organised similar events with key opinion leaders for its AD assets.

Exhibit 1: AlzeCure’s R&D pipeline

Source: AlzeCure

ACD440: Phase IIa trial for neuropathic pain in planning

ACD440 is being developed for peripheral neuropathic pain, which is a symptom of a broad group of different, underlying conditions such as diabetic nephropathy, chemotherapy induced pain or herpetic neuralgia. Given the potentially large patient heterogeneity across this indication, we believe that management will likely investigate ACD440 in specific sub-populations of patients. No specific guidance was provided at the R&D event on Phase IIa trial design, but we expect this will likely be communicated during H221 and should better define the commercial scope for ACD440. We note that an upcoming revision to the International Classification of Diseases and Related Health Problems (ICD) of the World Health Organization (WHO), effective 1 January 2022, should provide clearer diagnostic criteria for neuropathic pain and should help aid patient selection in future studies.

TrkA-NAM: Distinctly different mechanism to anti-NGFs

A deep-dive into the TrkA-NAM programme highlighted why this approach is differentiated from the nerve growth factor (NGF) targeting antibodies that, although effective, have disappointed due to safety issues (more background details are in our initiation report). Of particular note is Pfizer/Lilly’s tanezumab which remains under FDA review for osteoarthritic pain despite concerns surrounding its risk/benefit profile and the cases of rapidly progressing osteoarthritis observed across various trials. AlzeCure believes that TrkA-NAM could offer a safety improvement over anti-NGF antibodies through selectively attenuating NGF/TrkA signalling while sparing NGF/p75NTR signalling (more detailed explanation of mechanism of action is in our initiation report). So, TrkA-NAM is a more selective mechanism than Trk-inhibitors or anti-NGF antibodies. In addition, AlzeCure’s TrkA-NAM compounds are small molecules, which have several advantages over antibodies including more convenient administration and lower COGS. AlzeCure should present preclinical efficacy data at IASP in June 2021. The nomination of a clinical candidate is expected during H221.

In terms of a directly comparable programme, we note that Asahi Kasei is currently investigating its TrkA inhibitor, AK1830 (formerly ARRY-954), in two Phase II trials for osteoarthritic pain and lower back pain. What is particularly notable is that this was in-licensed as a preclinical asset from Array BioPharma in March 2016, in a deal worth c $75m ($12m upfront, $64m milestone plus royalties) for commercial rights in Asia, highlighting the near-term value which could be crystallised from the TrkA-NAM programme.

Valuation and financials

Our risk-adjusted NPV of AlzeCure is now SEK826m or SEK21.9 per share (from SEK729m or SEK19.3 per share), as we have increased our probability of success for ACD440 to 20% from 10%, updated for the last reported net cash position and rolling forward our model. A full breakdown of our valuation and underlying assumptions can be found in our initiation report.

Exhibit 2: AlzeCure sum-of-the-parts valuation

Product

Indication

Launch

Peak sales* ($m)

NPV
(SEKm)

Probability of success

rNPV
(SEKm)

NPV/share
(SEK)

NeuroRestore – ACD856

AD

2030

4,600

6,160.1

5.0%

495.6

13.1

Painless – ACD440

Neuropathic pain

2028

500

1,023.5

20.0%

236.6

6.3

Net cash, last reported

94.2

100.0%

94.2

2.5

Valuation

 

 

7,277.7

826.4

21.9

Source: Edison Investment Research. Note: WACC = 12.5%. *Peak sales are rounded to the nearest $100m.

In May, AlzeCure reported Q121 results that were broadly in-line with our expectations. The reported net cash of SEK94.2m at the end-Q121 should provide funding into 2022. We assume an illustrative long-term liability of SEK57m in 2022 (as per our research principles, in lieu of equity funding). Notably, its existing budget is sufficient to reach the final readouts from both clinical trials, as well as other potential catalysts from the preclinical R&D pipeline.

Exhibit 3: Financial summary

Year end 31 December

SEK'000s

2018

2019

2020

2021e

2022e

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Total revenues

0

0

0

0

0

Cost of sales

0

0

0

0

0

Gross profit

0

0

0

0

0

SG&A (expenses)

(2,558)

(6,035)

(9,375)

(9,609)

(9,850)

R&D costs

(36,828)

(44,499)

(61,861)

(71,861)

(75,454)

Other income/(expense)

3,597

(84)

152

0

(254)

Exceptionals and adjustments

 

0

0

0

0

0

Reported EBITDA

 

(35,789)

(50,618)

(71,084)

(81,470)

(85,558)

Depreciation and amortisation

(104)

(290)

(495)

(544)

(580)

Reported Operating Profit/(loss)

(35,893)

(50,908)

(71,579)

(82,015)

(86,137)

Finance income/(expense)

(92)

50

213

68

0

Other income/(expense)

0

0

0

0

0

Exceptionals and adjustments

0

0

0

0

0

Reported PBT

(35,985)

(50,858)

(71,366)

(81,947)

(86,137)

Income tax expense

0

0

0

0

0

Reported net income

 

(35,985)

(50,858)

(71,366)

(81,947)

(86,137)

Basic average number of shares, m

22.8

37.8

37.8

37.8

37.8

Basic EPS (SEK)

 

(1.58)

(1.35)

(1.89)

(2.17)

(2.28)

Diluted EPS (SEK)

(1.58)

(1.35)

(1.89)

(2.17)

(2.28)

BALANCE SHEET

Property, plant and equipment

 

597

1,768

1,944

2,071

2,162

Intangible assets

17

17

17

17

17

Other non-current assets

7

7

7

7

7

Total non-current assets

621

1,792

1,968

2,095

2,186

Cash and equivalents

 

234,549

182,499

112,434

30,356

1,000

Trade and other receivables

8

16

8

12

10

Other current assets

2,604

2,448

3,417

3,417

3,417

Total current assets

237,161

184,963

115,859

33,785

4,427

Non-current loans and borrowings*

0

0

0

0

56,870

Total non-current liabilities

 

0

0

0

0

56,870

Trade and other payables

 

3,646

2,997

3,966

3,966

3,966

Other current liabilities

967

1,751

3,106

3,106

3,106

Total current liabilities

4,613

4,748

7,072

7,072

7,072

Equity attributable to company

233,169

182,007

110,755

28,808

(57,329)

CASH FLOW

Operating Profit/(loss)

 

(35,893)

(50,908)

(71,579)

(82,015)

(86,137)

Depreciation and amortisation

104

290

495

544

580

Other adjustments

0

0

0

0

0

Movements in working capital

(392)

283

1,363

(4)

2

Interest paid / received

(93)

50

213

68

0

Income taxes paid

0

0

0

0

0

Cash from operations (CFO)

(36,274)

(50,285)

(69,508)

(81,407)

(85,556)

Capex

(459)

(1,461)

(671)

(671)

(671)

Acquisitions & disposals net

 

0

0

0

0

0

Other investing activities

0

0

0

0

0

Cash used in investing activities (CFIA)

(459)

(1,461)

(671)

(671)

(671)

Net proceeds from issue of shares

217,330

(381)

0

0

0

Movements in debt

0

0

0

0

56,870

Other financing activities

0

77

114

0

0

Cash from financing activities (CFF)

217,330

(304)

114

0

56,870

Increase/(decrease) in cash and equivalents

180,597

(52,050)

(70,065)

(82,078)

(29,356)

Cash and equivalents at beginning of period

53,952

234,549

182,499

112,434

30,356

Cash and equivalents at end of period

234,549

182,499

112,434

30,356

1,000

Net (debt) cash

234,549

182,499

112,434

30,356

(55,870)

Source: AlzeCure Pharma accounts, Edison Investment Research. Note: *Long-term debt used instead of equity issue.


General disclaimer and copyright

This report has been commissioned by AlzeCure Pharma and prepared and issued by Edison, in consideration of a fee payable by AlzeCure Pharma. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

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Copyright: Copyright 2021 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

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Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by AlzeCure Pharma and prepared and issued by Edison, in consideration of a fee payable by AlzeCure Pharma. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2021 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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