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    ACPH   GB00BYWF9Y76

ACACIA PHARMA GROUP PLC

(ACPH)
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Acacia Pharma : Corporate Presentation October 2020

10/09/2020 | 08:40am EDT

Acacia Pharma Group plc

Non-Confidential Corporate Presentation

September 2020

Our Vision:

Delivering innovative products to enhance surgical patients' recovery

Important Notice

The information contained in this presentation (this "presentation") has been prepared by Acacia Pharma Group plc ("the Company") as at the date of this presentation and is subject to updating, completion, revision, further verification and amendment without notice. This presentation is for general information only and is the property of the Company. Making this presentation available in no circumstances whatsoever implies the existence of a commitment or contract by or with the Company, or any of its affiliated entities, or any of its or their respective subsidiaries, directors, officers, representatives, employees, advisers or agents for any purpose.

This presentation has not been approved by the United Kingdom Listing Authority under the Prospectus Rules (made under Part VI of the Financial Services and Markets Act 2000 ("FSMA")), by the Belgian Financial Services and Markets Authority or otherwise, by the regulated market of Euronext Brussels. This presentation does not constitute or form part of any offer for sale or solicitation of any offer to buy or subscribe for any securities nor shall it or any part of it form the basis of or be relied on in connection with, or act as any inducement to enter into, any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information or opinions contained in this presentation or on the completeness, accuracy or fairness thereof.

No undertaking, representation, warranty or other assurance, express or implied, is made or given by or on behalf of the Company or its directors, officers, partners, employees, agents or advisers or any other person as to the accuracy or completeness of the information or opinions contained in this presentation and no responsibility or liability is accepted by any of them for any such information or opinions or for any errors, omissions, misstatements, negligence or otherwise for any other communication written or otherwise. In addition, in issuing this presentation, the Company undertakes no obligation to update or to correct any inaccuracies which may become apparent in this presentation. Notwithstanding the aforesaid, nothing in this paragraph shall exclude liability for any undertaking, representation, warranty or other assurance made fraudulently.

The statements contained in this presentation may include "forward looking statements" that express expectations of future events or results. All statements based on future expectations rather than on historical facts are forward looking statements that involve a number of risks and uncertainties and the Company cannot give assurance that such statements will prove to be correct. Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. The Company gives no undertaking to update forward looking statements to reflect any changes in expectations, events, conditions or circumstances upon which such statements are made.

The presentation should not be considered a recommendation by the Company or any of its affiliated entities, or any of its or their respective subsidiaries, directors, officers, representatives, employees, advisers or agents in connection with any purchase of or subscription for securities of the Company.

This presentation is not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. In particular, this presentation should not be copied or distributed by recipients and should not be distributed by any means including electronic transmission, to persons with addresses in the United States of America, Canada, Australia, South Africa or Japan their possessions or territories or to any citizens thereof, or to any corporation, partnership or such entity created or organised under the laws thereof. Any such distribution contrary to the above could result in a violation of the laws of such countries.

2

Acacia Pharma Group - in Summary

Acacia Pharma Group plc: an integrated specialty pharma company entering commercial phase

  • IPO 2018 on Euronext Brussels (ticker: ACPH)
  • Key focus: surgeries, procedures, cancer therapy
  • Products to increase procedural throughput in even greater demand due to COVID-19

BARHEMSYS® - now FDA approved

  • Broad label for prevention and treatment of Post-Operative Nausea and Vomiting (PONV)
  • Key target: estimated 16 million patients a year in US with PONV after failure of generic antiemetics1
  • Estimated $2.6 billion annual total addressable market2

BYFAVO™ - now FDA approved3

  • Indicated for procedural sedation in adults, supported by strong clinical data package
  • Key target: 40 million procedures a year in US, including 25 million GI procedures4
  • Estimated >$1 billion annual total addressable market5

Core commercial organization in place ready for product launches in 2H 2020

  • Key sales, marketing, medical affairs, commercial operations leadership in place
  • Sales representatives onboard late September
  • Drug shortages and surgery backlog creating pent-up demand

1 Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses as follows: National Hospital Discharge Survey, 2006; National Survey of Ambulatory Surgery, 2006 (as revised in 2009); Source Healthcare; NCHS 2005; Life Science Strategy Group, LLC Market Research; Apfel et al.,2004. 2 Based on the calculations in (1) multiplied by the number of doses per patient at a selling price of $80 per 10mg dose. 3 Subject to scheduling by DEA

3 4 iData Research, US Market Report Procedure Numbers for Gastrointestinal Endoscopic Devices February 2019; American Society of Anesthesiologists, Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018; and Quantitative Market Research prepared by The Link Group for Cosmo Technologies (March 2019). 5 Based on the calculation in (4) multiplied by the number of doses per patient at a selling price of $25-35 per dose.

Leadership Team with Experience to Deliver the Vision

Mike Bolinder

CEO

Gary Gemignani

CFO

Dr Gabriel Fox

CMO

  • Joined 2015, became CEO 1 August 2019
  • 18+ years in pharma sales & marketing
  • Relevant commercial experience with OFIRMEV® at Cadence/Mallinckrodt
  • Joined as CFO January 2020
  • 30+ years finance experience in healthcare
  • Relevant CFO experience in early commercial stage pharma
  • Joined as CMO 2008
  • 23+ years in pharmaceutical medicine
  • Relevant development and medical- marketing experience in repurposed drugs

4

Late Stage Commercial Product Pipeline

Product

Indication

Preclinical Phase 1

Phase 2

Phase 3

Filing

Approval

Postoperative

BARHEMSYS® Nausea &

Vomiting (PONV)

BYFAVO Procedural

Sedation

Chemotherapy

APD403 Induced Nausea

& Vomiting

5

Patent Terms and Commercial Rights

BARHEMSYS

• Orange Book listed, current patent term to 2031,

expected ability to extend1

• IP protection in all major pharmaceutical markets:

• Intend to directly commercialize in the US

• Exploring partnership opportunities OUS

• Approved for PONV, developing for CINV

BYFAVO

• Orange Book listing expected soon, current patent

term to 2031, expected ability to extend1

• In-licensed commercial rights for US (largest pharmaceutical market)

• Approved for procedural sedation, can develop for ICU sedation and general anesthesia

6

1 Patent extension currently under review by US Patent and Trademark Office for BARHEMSYS and request is expected to be made for BYFAVO. Management believes the

patent terms will be extended to 2034 for both BARHEMSYS and BYFAVO.

COVID-19 Situation and Impact

  • The OR accounts for up to 65% of hospital profit margin, so this missing volume is cutting deeply into cash flow and net income.

-Becker's Hospital Review1

COVID-19 impact on

• Non-essential surgeries cancelled creating a significant backlog

hospitals and surgical

• Physical access to hospital decision-makers even more restricted

centers

Hospital profits have

• Surgeries and procedures are major contributors to hospital profits

suffered and need to be

• Providers need to dramatically increase throughput to regain lost profits

restored quickly

We believe our products and team are ideally positioned to help

  • BARHEMSYS and BYFAVO can help improve patient throughput - both now even more relevant and of greater interest to customers
  • Our strong relationships will help us gain access to key decision-makers

1 How to rebuild surgical revenue after COVID-19,Becker's Hospital Review, accessed via https://www.beckershospitalreview.com/strategy/how-to-rebuild-surgical-7 revenue-after-covid-19-even-if-you-just-lost-60-of-your-or-volume.html

BARHEMSYS®

(amisulpride for injection)

The first and only FDA-approved product for PONV rescue treatment1

1 FDA labels for other recommended treatments do not include treatment after failed prophylaxis. Treatment agents recommended by Society for Ambulatory Anesthesiology Consensus Guidelines (2014). Habib et al (2019): no agent has previously been shown in a prospective trial to be more effective than a placebo for treating PONV for patients who have failed prophylaxis.

BARHEMSYS® and the US Opportunity in PONV

BARHEMSYS

A new option in PONV

  • BARHEMSYS is the only FDA-approveddrug for PONV rescue after failed prophylaxis1
  • Dopamine D2/D3 antagonist with broad, differentiated label
  • Offers significant economic savings to hospital vs current standard of care

High gross profit and secure supply chain

  • Cost of goods ~10% of sale price
  • Five-yearroom temperature shelf-life
  • Substantial product inventory to minimize supply risk

Estimated ~65m eligible surgeries annually, ~49m patients receive preventative antiemetics4

Large US market

Estimated ~16m patients still develop PONV and need rescue treatment3

opportunity in PONV2

Total addressable PONV rescue market estimated at ~$2.6 billion/year4

Concentrated market, addressable by small direct sales force

  • Estimated 80% of surgeries carried out in ~1,600 hospitals5
  • 30 sales territories address accounts with greatest immediate opportunity
  • Product in US supply chain as of late August

1 FDA labels for other recommended treatments do not include treatment after failed prophylaxis, 2 This is the belief of the Company. 3 Company market size estimates based upon: 2006 National Hospital Discharge Survey; National

9 Survey of Ambulatory Surgery, 2006 (as revised in 2009); LSSG Quantitative Research November 2014; Apfel, NEJM 2004. Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses. 4 Based upon price of $80 per 10mg rescue dose with, on average, 2 rescue doese per patient, and the above estimates. 5 Symphony Health, Source Non Retail, August 2017 - July 2018.

Nausea and Vomiting is a Complex Process

Managed by combinations of antiemetics targeting multiple mechanisms

Fear, anxiety, memory

Bloodstream emetogens

GI tract

Vestibular system

D2

5HT3

NK1

H1

Inflammation?

Multiple pathways, including:

Current standard of care for

Despite this >30% of

• Serotonin (5-HT3)

PONV prophylaxis1:

Dopamine (D2)

5-HT3 antagonist

surgical patients still

• Histamine

(e.g. ondansetron)

get PONV2

• NK1

± corticosteroid

10 1 Gan et al, 2020. 2 Apfel et al, 2004; Habib et al, 2019.

Targeting PONV Rescue Market

~65m invasive

~49m receive

~32% fail

~16m patients

surgical

per year require

antiemetic

prophylaxis and

procedures per

PONV rescue

prophylaxis1

get PONV1

year (US)1

treatment

~18m high-risk patients per year eligible for combination prophylaxis1

Total estimated addressable market in PONV rescue $2.6B per year

Secondary market in combination prophylaxis in highest-risk patients, estimated to be worth $720M per year2

1 Company market size estimates based upon: 2006 National Hospital Discharge Survey; National Survey of Ambulatory Surgery, 2006 (as revised in 2009); LSSG Quantitative Research November 2014; Apfel et al, 2004.

11 Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses. 2 Based on selling price of $80 per 10 mg rescue dose and average 2 rescue doses per patient; $40 per 5 mg prophylaxis dose.

Generic Options for Rescue Treatment are Problematic

  • When PONV prophylaxis has failed, patients should receive antiemetic treatment from a different pharmacological class to the PONV prophylaxis
    • Consensus Guidelines1

Antiemetic

Can't redose

Efficacy issues

Safety issues

Current share of

rescue patients4

Ondansetron

1

69%

Dexamethasone

1

2

19%

Metoclopramide

1

1

19%

Promethazine

1

11%

BARHEMSYS

3

3

3

INTENT TO PRESCRIBE4

61%

12

1 Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. 2 Wang et al (2000). 3 BARHEMSYS label prescribing information. 4 LSSG quantitative market research among 152

anesthesiologists and general surgeons. Question referred to "Product X" with a description matching the profile of BARHEMSYS. Note: current shares totals > 100% as responses included some combination therapy.

BARHEMSYS® - Compelling Clinical and Commercial Proposition

Only FDA-approved product for PONV rescue1

  • Only drug proven in randomized clinical trial to work in PONV rescue2
  • Excellent safety profile demonstrated in clinical studies
  • Also demonstrated to be effective for prevention

Throughput and health economic benefits

  • 35-minutereduction in PACU stay
  • 6-hourreduction in hospital stay
  • Offers significant economic savings to hospital vs current standard of care

Convenient, easy to use, high margin product

  • 5-yearroom temperature shelf-life
  • Fits in auto-dispensing (Pyxis™) machines
  • Cost of goods ~10% of sale price

Helps post-COVID pressure to get through surgical backlog

  • Shorter time in PACU allows increased surgical throughput
  • Better efficacy and safety means better recovery and patient experience

13

1 FDA labels for other recommended treatments do not include treatment after failed prophylaxis. Treatment agents recommended by Society for Ambulatory Anesthesiology Consensus Guidelines (2014). Habib et al (2019): no agent has previously been

shown in a prospective trial to be more effective than a placebo for treating PONV for patients who have failed prophylaxis. 2 FDA labels for other recommended treatments do not include treatment after failed prophylaxis.

Highly Experienced Commercial Team in Hospital Space

Midwest

Northeast

West

Mid-Atlantic

South-Central

Southeast

Commercial Leadership TeamSales Leadership Team

28+

60+

22

18+

Years avg

Launches

Years avg

Years

industry

industry

hospital

14

Team has direct experience successfully launching OFIRMEV into same market to same key customers

Field Force Design

  • 1 VP of Sales
  • 1 National Accounts Group Leader
  • 1 National MSL Group Leader
  • 6 Sales Regions each with:
    • 1 RBD
    • 1 MSL
    • 1 National Account Director
    • 5 Hospital Territory Managers

National Accounts TeamMedical Science Liaison Team

24

21+

22

10+

Years avg

Years

Years avg

Years as

industry

hospital

industry

MSL

Commercial Roll-out Underway

Manufacturing and distribution networks in place

  • Substantial API and finished product manufactured to de-risk supply chain1
  • Service agreements in place with 3rd party logistics provider and key wholesalers
  • Contracting discussions underway with top Group Purchasing Organizations and Integrated Delivery Networks

PONV and

Presence at major congresses

BARHEMSYS education

Print and online advertising

campaigns ongoing

F2F and virtual meetings in key centers

Leading PONV experts involved in

Strong KOL and

BARHEMSYS clinical development trials

advocate support

Additional anesthesia, surgery and

pharmacy KOLs being educated

Early adopting sites and formulary champions identified

  • Extensive institution profiling already undertaken
  • Key clinical champions identified in hundreds of hospitals

15

1 This is the belief of the Directors of the company.

Formulary Review Phase to Begin 2H 2020

Post-COVID pressures improve our access to key decision-makers

  • Surgery backlogs are major issues for US hospitals
  • Value of BARHEMSYS in improving throughput facilitates our access to key decision-makers

Demonstrate unmet need, appropriate use & health economic benefit

  • Existing products unsuitable for rescue
  • BARHEMSYS is only FDA-approved product for rescue
  • Offers significant economic savings to hospital vs current standard of care

Formulary adoption and pull-through will build sales

  • P&T Committee approval typically takes 9-12 months on average2
  • Protocols, standing orders and point-of-care supplies drive sales pull-through

16

Anaesthesia

Pharmacy

Key Surgeons

Reviews assessment and votes to revise formulary

Pharmacy &

Therapeutics Committee

Appropriate Use Standing Orders

Point-of-Care

and Protocols

Stocking

Major Follow-on Opportunity in Chemotherapy Induced Nausea & Vomiting (CINV) for APD403

~4 million cycles of highly emetogenic

CINV market opportunity

chemotherapy (HEC) every year in US1

is similar to PONV

Preventive anti-emetics

recommended for 4 days per cycle2

Despite use of three-antiemetic

Significant unmet need

cocktail, 50% of patients still suffer

remains in delayed phase

with delayed CINV3

CINV

Oncologists target zero tolerance of

CINV2

Positive data in one randomized trial:

One further pivotal trial

significant reduction in incidence of

required to support new

delayed CINV3

indication

Further trial to be conducted by 2022

>90%

Two phases

of CINV4:

patients get CINV when

Acute

receiving HEC4

(Day 1)

Delayed

(Day 2-5)

Delayed

CINV

NDA submission:

Potential

is the unmet medical

2023

need

32%

relative risk reduction of delayed CINV3

17

1

Morgan Stanley analyst note on Tesaro, 2012, Deutsche Bank analyst note on Tesaro, 2013, Edison analyst note on Tesaro, 2014, NCCN Guidelines for antiemesis, 2017.

2

NCCN Guidelines 2017. 3 Calculated from DN10016 study report. 4 Roila et al (2010) , Hesketh (2011).

BYFAVO™

(remimazolam) for injection

Rapid onset/offset procedural sedative with favorable safety profile

Procedural Sedation Market Opportunity

~40 million1

~25 million

>80%

procedures each year

GI procedures performed

GI procedures have sedation administered

requiring sedation

each year2

by an anesthesia provider3

>6 million

~4 million

~1 million

~1.5 million

Interventional

Ophthalmic

Bronchoscopy6

Cosmetic/

Radiology4

Procedures5

Plastic Surgery7

Total addressable market in procedural sedation ~$1B/year8

1 Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses. 40 million includes other opportunities: CC (MHA National) EP (dicardiology), Dental (areadentist), Plastic Surgery (American Society of Plastic Surgeons), ECT (MHA National). 2 iData Research, US Market Report Procedure Numbers for Gastrointestinal Endoscopies Nov 2016; CDC website. 3 Quantitative Market Research prepared by The Link Group for Cosmo Technologies (March 2019). 4 Report on interventional Radiology November/December 2007. 5 American Medical Association 2011. 6 iData Bronchoscopy 2019 report. 7 American Society of Plastic Surgeons 2018. 8 Based on the calculation in iData

19 Research, US Market Report Procedure Numbers for Gastrointestinal Endoscopic Devices February 2019; American Society of Anesthesiologists, Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018; and Quantitative Market Research prepared by The Link Group for Cosmo Technologies (March 2019) multiplied by the number of doses per patient at a selling price of $25-35 per dose.

BYFAVO Addresses Unmet Need in Procedural Sedation

Propofol

fast acting but

significant safety issues1,2

  • Rapid onset and offset anesthetic with narrow therapeutic index1
  • Dose-relatedcardiorespiratory depression, pain at injection site1
  • Non-lineardosing effects due to individual variability4
  • Needs continuous monitoring by anesthesiologist, no reversal agent2
  • Lipid formulation susceptible to bacterial contamination4

Midazolam

better safety profile but

longer onset and recovery1,2

  • Benzodiazepine sedative, reversible by flumazenil1
  • Slower onset and offset2,3
  • Metabolized by cytochrome system; individual variability affects sedation1
  • Active metabolite can accumulate and cause prolonged sedation2
  • Risk of respiratory depression1

BYFAVO

fast acting AND favorable

safety profile1,2

  • Rapid onset/offset1,2,3 benzodiazepine
  • Rapid biotransformation into inactive metabolites via non- specific tissue esterases - not dependent on liver enzymes1
  • Predictable behavior, no pharmacokinetic drug interactions5
  • Reliable sedation, reliable safety profile1
  • Reversible by flumazenil1

20

1

Colao J, et al. J Anesth Clin Res. 2016; 7:690. 2 Whizar-Lugo V, et al. J Anesth Crit Care. 2016; 4(6): 00166. 3 Rex DK et al. Gastrointest Endosc. 2018 Sep;88(3):427-437.

4

Prescribing label for Propofol. 5 Prescribing label for BYFAVO.

Rapid Onset/Offset with a Favorable Safety Profile1

40

30

Average Procedure Timings1

Key Adverse Events1

BYFAVO

Midazolam

Any adverse event

74%

91%

20

10

0

6

4

13

19

Vascular disorders

62%

81%

Cardiac disorders

18%

26%

Respiratory disorders

4%

6%

BYFAVOMidazolam

Minutes to fully alert after procedure Minutes to procedure start

21 1 Rex DK et al. Gastrointest Endosc. 2018 Sep;88(3):427-437.

BYFAVO - Compelling Clinical Proposition

Approved with a broad label

  • Indicated for procedural sedation in adults in procedures lasting 30 mins or less
  • Substantial clinical data package shows compelling efficacy and safety in colonoscopies and bronchoscopies, including least fit patients

Throughput and health economic benefits

  • Rapid onset/offset enables shorter procedure times and greater patient throughput for hospitals and surgical centers compared to other recommended treatments

Commercial synergy with BARHEMSYS

  • Target prescribers: anesthesiologists and proceduralists in hospitals and ambulatory surgery centers

Helps post-COVID pressure to alleviate procedural backlog

  • Shorter procedure times allow increased procedural volumes
  • Both midazolam and propofol currently on FDA drug shortages list

22

Acacia Pharma Group - Financial Summary

Listed on Euronext

IPO in March 2018

Key Shareholders1

~85m shares outstanding

Brussels exchange

~80% free float

23%

24%

Cash position

• Cash balance at June 30, 2020 was ~$24.6m

4%

Raised $30m August 2020

4%

5%

23%

• Hercules ~$8.6m outstanding as of June 30, 2020

Debt facilities

17%

Additional ~$27m loan facility available from

Cosmo (~$16.5m already drawn upon)

Cosmo Technologies Ltd

Gilde Healthcare

Lundbeckfonden Invest

Current milestone

€5m in ACPH shares due upon first commercial sale

F-Prime Capital Partners

KBC Bank

obligations

of BYFAVO

AXA Investment Management

Other

23

1:Shareholder data as of July 22, 2020.

Acacia Pharma Group - in Summary

Acacia Pharma Group plc: an integrated specialty pharma company entering commercial phase

  • IPO 2018 on Euronext Brussels (ticker: ACPH)
  • Key focus: surgeries, procedures, cancer therapy
  • Products to increase procedural throughput in even greater demand due to COVID-19

BARHEMSYS® - now FDA approved

  • Broad label for prevention and treatment of Post-Operative Nausea and Vomiting (PONV)
  • Key target: estimated 16 million patients a year in US with PONV after failure of generic antiemetics1
  • Estimated $2.6 billion annual total addressable market2

BYFAVO™ - now FDA approved3

  • Indicated for procedural sedation in adults, supported by strong clinical data package
  • Key target: 40 million procedures a year in US, including 25 million GI procedures4
  • Estimated >$1 billion annual total addressable market5

Core commercial organization in place ready for product launches in 2H 2020

  • Key sales, marketing, medical affairs, commercial operations leadership in place
  • Sales representatives onboard late September
  • Drug shortages and surgery backlog creating pent-up demand

1 Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses as follows: National Hospital Discharge Survey, 2006; National Survey of Ambulatory Surgery, 2006 (as revised in 2009); Source Healthcare; NCHS 2005; Life Science Strategy Group, LLC Market Research; Apfel et al.,2004. 2 Based on the calculations in (1) multiplied by the number of doses per patient at a selling price of $80 per 10mg dose. 3 Subject to scheduling by DEA

24 4 iData Research, US Market Report Procedure Numbers for Gastrointestinal Endoscopic Devices February 2019; American Society of Anesthesiologists, Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018; and Quantitative Market Research prepared by The Link Group for Cosmo Technologies (March 2019). 5 Based on the calculation in (4) multiplied by the number of doses per patient at a selling price of $25-35 per dose.

Disclaimer

Acacia Pharma Group plc published this content on 09 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 October 2020 12:39:04 UTC


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Sales 2021 1,18 M 1,62 M 1,62 M
Net income 2021 -40,4 M -55,5 M -55,5 M
Net cash 2021 2,69 M 3,69 M 3,69 M
P/E ratio 2021 -3,58x
Yield 2021 -
Capitalization 148 M 204 M 204 M
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Nbr of Employees 72
Free-Float 63,2%
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Michael Bolinder Chief Executive Officer & Executive Director
Gary G. Gemignani Chief Financial Officer
Scott A. Byrd Chairman
Gabriel Fox Chief Medical Officer
John Robert Brown Senior Independent Non-Executive Director
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