Acacia Pharma — Progressing on all-important formulary wins

Acacia Pharma (EU: ACPH)

Last close As at 27/04/2024

1.28

0.04 (3.23%)

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Research: Healthcare

Acacia Pharma — Progressing on all-important formulary wins

Acacia Pharma has updated the market on the significant ongoing progress of US formulary wins for BARHEMSYS for the treatment and prevention of post-operative nausea and vomiting (PONV) and BYFAVO, an intravenous sedative for use during invasive medical procedures. Formulary access is key for initial sales in the hospital setting and early BARHEMSYS sales should start to trickle through by end FY21/early FY22, while the focus for BYFAVO remains on formulary wins. Obtaining wide formulary adoption is critical and should translate to significant revenue generation from FY22 and maiden operating profit from FY23. Our valuation of Acacia Pharma is unchanged at €1,278m.

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Healthcare

Acacia Pharma

Progressing on all-important formulary wins

Commercial update

Pharma & biotech

2 July 2021

Price

€2.16

Market cap

€215m

US$1.18/€

Net cash ($m) at 31 December 2020

10.0

Shares in issue

99.7m

Free float

80%

Code

ACPH

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(6.9)

(12.0)

(27.3)

Rel (local)

(8.4)

(16.8)

(41.9)

52-week high/low

€3.37

€1.85

Business description

Acacia Pharma is a commercial-stage biopharmaceutical company focused on commercialising novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures or chemotherapy. It has two assets, BARHEMSYS (launched for the treatment of PONV in the United States) and in-licensed asset BYFAVO (launched for procedural sedation in the United States).

Next events

Interim results

September 2021

BARHEMSYS and BYFAVO formulary wins

2021

Initiation of pivotal CINV trial (APD403)

2022

Analysts

Dr Susie Jana

+44 (0)20 3077 5700

Dr John Priestner

+44 (0)20 3077 5700

Acacia Pharma is a research client of Edison Investment Research Limited

Acacia Pharma has updated the market on the significant ongoing progress of US formulary wins for BARHEMSYS for the treatment and prevention of post-operative nausea and vomiting (PONV) and BYFAVO, an intravenous sedative for use during invasive medical procedures. Formulary access is key for initial sales in the hospital setting and early BARHEMSYS sales should start to trickle through by end FY21/early FY22, while the focus for BYFAVO remains on formulary wins. Obtaining wide formulary adoption is critical and should translate to significant revenue generation from FY22 and maiden operating profit from FY23. Our valuation of Acacia Pharma is unchanged at €1,278m.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/19

0.0

(21.1)

(0.38)

0.00

N/A

N/A

12/20

0.2

(28.5)

(0.38)

0.00

N/A

N/A

12/21e

8.0

(39.9)

(0.40)

0.00

N/A

N/A

12/22e

39.7

(34.1)

(0.33)

0.00

N/A

N/A

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

On track to meet FY21 formulary wins

At 30 June 2021 BARHEMSYS (amisulpride injection) was listed on formulary at 201 institutions, significantly ahead of schedule to meet management guidance for 300 by year end and representing a mid-80% win rate. This exceeds original expectations and is particularly impressive given the backdrop of COVID-19. BARHEMSYS use results in shorter times in post-anaesthesia care units, which enables increased surgical throughput. BYFAVO (remimazolam) is now on 47 accounts and management believes it is on track to meet its FY21 target of 150. BYFAVO is the first sedative to be launched in the US in 20 years. Importantly, the broad label granted by the FDA covers all adult invasive medical procedures of less than 30-minute duration (extending utility beyond bronchoscopy and gastroscopy procedures to ophthalmology, interventional radiology and plastic surgery).

FY21 forecasts subject to initial sales pull through

By marketing two products through a small but experienced salesforce, Acacia should realise significant operational synergies. Our peak sales forecasts for BARHEMSYS ($405.3m) and BYFAVO ($125.6m) are unchanged. Our FY21 forecasts are dependent on initial sales pull-through subject to formulary wins and increased physical access to hospitals. We note that further delays to elective procedures are a distinct possibility and present uncertainty. However, the pent-up demand for surgical procedures and sedative drug shortages in the United States could lead to early sales uptake of both products.

Valuation: €1,278m or €12.8/share

Our unchanged valuation is €1,278m or €12.8/share. Acacia is funded into 2022 and we model additional funding of c $35m will be needed in H222 for further commercial expansion. Given Acacia’s operational focus on the United States and the opportunities for BARHEMSYS and BYFAVO in this key market, we believe a Nasdaq listing would be appropriate to further widen the investor base.

Exhibit 1: Financial summary

Year end 31 December (US$m)

 

 

2018

2019

2020

2021e

2022e

PROFIT & LOSS

 

 

 

 

 

 

 

Operating revenues

 

 

0.0

0.0

0.2

8.0

39.7

Cost of sales

 

 

0.0

0.0

(0.0)

(0.5)

(3.1)

Gross profit

 

 

0.0

0.0

0.2

7.5

36.6

Gross margin %

 

 

N/A

N/A

86%

94%

92%

SG&A (expenses)

 

 

(15.0)

(18.5)

(31.0)

(50.6)

(68.9)

R&D costs

 

 

(5.0)

(3.9)

(0.1)

(1.0)

(7.0)

Other income/(expense)

 

 

0.0

0.0

0.0

0.0

0.0

EBITDA

 

 

(20.0)

(22.3)

(27.8)

(36.0)

(31.2)

Reported operating Income

 

 

(20.0)

(22.4)

(30.9)

(44.1)

(39.3)

Operating Margin %

 

 

N/A

N/A

N/A

N/A

N/A

Finance income/(expense)

 

 

(1.5)

(1.1)

(3.2)

(3.9)

(2.8)

Exceptionals and adjustments

 

 

0.0

0.0

0.0

0.0

0.0

Reported profit before tax

 

 

(21.6)

(23.5)

(34.1)

(48.0)

(42.1)

Normalised profit before tax

 

 

(20.9)

(21.1)

(28.5)

(39.9)

(34.1)

Income tax expense (includes exceptionals)

 

 

0.9

0.7

0.6

0.7

0.7

Reported net income

 

 

(20.7)

(22.8)

(33.5)

(47.3)

(41.4)

Basic average number of shares, m

 

 

44.1

53.7

73.6

98.1

99.7

Year-end number of shares, m

 

 

53.3

54.9

89.6

99.7

99.7

Basic EPS ($)

 

 

(0.47)

(0.43)

(0.45)

(0.48)

(0.42)

Adjusted EPS ($)

 

 

(0.45)

(0.38)

(0.38)

(0.40)

(0.33)

Dividend per share ($)

 

 

0.00

0.00

0.00

0.00

0.00

 

 

 

 

 

 

 

 

BALANCE SHEET

 

 

 

 

 

 

 

Property, plant and equipment

 

 

0.0

0.0

0.0

0.3

2.2

Intangible assets

 

 

0.0

0.0

52.2

44.1

36.1

Other non-current assets

 

 

0.0

0.4

0.3

0.3

0.3

Total non-current assets

 

 

0.0

0.4

52.4

44.8

38.6

Cash and equivalents

 

 

37.4

17.0

46.7

35.0

31.0

Inventories

 

 

0.0

0.0

2.7

1.0

4.3

Trade and other receivables

 

 

0.4

0.6

0.5

1.4

4.3

Other current assets

 

 

0.9

0.7

0.6

0.6

0.6

Total current assets

 

 

38.7

18.3

50.4

38.0

40.2

Non-current loans and borrowings

 

 

8.9

4.7

31.3

31.3

66.3

Other non-current liabilities

 

 

0.0

0.0

0.0

0.0

0.0

Total non-current liabilities

 

 

8.9

4.7

31.3

31.3

66.3

Trade and other payables

 

 

4.7

4.2

5.7

6.9

9.4

Current loans and borrowings

 

 

0.5

5.5

5.4

0.0

0.0

Other current liabilities

 

 

0.0

0.0

0.0

0.0

0.0

Total current liabilities

 

 

5.2

9.6

11.1

6.9

9.4

Equity attributable to company

 

 

24.7

4.3

60.5

44.5

3.1

 

 

 

 

 

 

 

 

CASH FLOW STATEMENT

 

 

 

 

 

 

 

Profit before tax

 

 

(21.6)

(23.5)

(34.0)

(48.0)

(42.1)

Depreciation and amortisation

 

 

0.0

0.1

3.1

8.1

8.1

Share based payments

 

 

0.6

2.4

2.6

0.0

0.0

Other adjustments

 

 

1.5

1.1

3.2

3.9

2.8

Movements in working capital

 

 

(3.9)

(0.8)

(1.0)

2.0

(3.7)

Interest paid

 

 

0.0

0.0

0.0

(3.9)

(2.8)

Income taxes paid

 

 

0.4

0.8

0.7

0.7

0.7

Cash from operations (CFO)

 

 

(15.4)

(19.8)

(25.4)

(37.3)

(37.1)

Capex

 

 

0.0

0.0

0.0

(0.4)

(1.9)

Acquisitions & disposals net

 

 

0.0

0.0

0.0

0.0

0.0

Other investing activities

 

 

0.2

0.4

0.0

0.0

0.0

Cash used in investing activities (CFIA)

 

 

0.2

0.4

0.0

(0.3)

(1.9)

Net proceeds from issue of shares

 

 

47.1

0.2

48.4

31.4

0.0

Movements in debt

 

 

1.8

(1.0)

7.7

(5.4)

35.0

Other financing activities

 

 

0.0

(0.1)

(0.1)

0.0

0.0

Cash from financing activities (CFF)

 

 

48.9

(0.9)

56.0

25.9

35.0

Cash and equivalents at beginning of period

 

 

4.1

37.4

17.0

46.7

35.0

Increase/(decrease) in cash and equivalents

 

 

33.7

(20.3)

30.7

(11.7)

(3.9)

Effect of FX on cash and equivalents

 

 

(0.4)

(0.1)

(1.0)

0.0

0.0

Cash and equivalents at end of period

 

 

37.4

17.0

46.7

35.0

31.0

Net (debt)/cash

 

 

28.1

6.9

10.0

3.7

(35.3)

Source: Acacia Pharma, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by Acacia Pharma and prepared and issued by Edison, in consideration of a fee payable by Acacia 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

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 Acacia Pharma and prepared and issued by Edison, in consideration of a fee payable by Acacia 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

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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