Acacia Pharma Group plc

2020 Year End Results Presentation

March 29, 2021

Delivering innovative products to enhance surgical patients' recovery

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Acacia Pharma Group - a transformational year in 2020

BARHEMSYS® - FDA approved for PONV, launched late 2020

  • Broad label for prevention and treatment of Post-Operative Nausea and Vomiting (PONV)

  • • Only agent approved for 'Rescue' of ~16m patients p.a. in US with PONV after generic antiemetics fail1

  • • PONV "rescue" is an estimated $2.7 billion annual total addressable market2

Commercialization began in 2H 2020 and showing good progress

  • Strong sales, marketing, medical affairs, commercial operations teams in place

  • Sales team deployed against ~900 initial targeted hospital accounts since mid-October

  • Drug shortages and surgery backlog creating pent-up demand (heightened by Covid)

BYFAVO - In-licensed, FDA approved for procedural sedation, launched Jan 2021

  • Indicated for procedural sedation in adults - launch benefitting from shared value proposition

  • Key target: 40m procedures a year in US, including 25m GI procedures3

  • Estimated >$1.5 billion annual total addressable market4

Strong corporate progress

  • Balance sheet strengthened with debt and equity financings

  • Gary Gemignani appointed CFO

  • Named BEL Small Company of the Year for second consecutive year

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 WAC price of $85 per 10mg dose. 3 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). 4 Based on the calculation in (4) multiplied by the number of doses per patient at a WAC price of $39 per dose.

We have been able to make significant progress in a very challenging operational environment caused by the global pandemic

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

  • Non-essential surgeries cancelled creating a significant backlog

  • Physical access to hospital decision-makers even more restricted

  • Surgeries and procedures are major contributors to hospital profits

  • Providers need to dramatically increase throughput to regain lost profits

  • BARHEMSYS and BYFAVO can help improve patient throughput - both are now even more relevant and of greater interest to customers due to COVID

  • Our strong relationships are helping us gain access to key decision-makers

1 How to rebuild surgical revenue after COVID-19,Becker's Hospital Review, accessed viahttps://www.beckershospitalreview.com/strategy/how-to-rebuild-surgical-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 is the only FDA-approved drug 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

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

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

  • Total addressable PONV rescue market estimated at ~$2.7 billion/year4

  • Estimated 80% of surgeries carried out in ~1,200 hospitals5

  • 30 sales territories address accounts with greatest immediate opportunity

  • Sales team began customer engagement in mid-October

  • Cost of goods ~10% of sale price

  • Substantial product inventory to minimize supply risk

  • Worldwide rights and exploring out-licensing opportunities in OUS markets

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 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 WAC price of $85 per 10mg rescue dose with, on average, 2 rescue doses per patient, and the above estimates. 5 Symphony Health, Source Non Retail, August 2017 - July 2018.

Total estimated addressable market in PONV rescue $2.7B per year

Secondary market in combination prophylaxis in highest-risk patients, estimated to be worth $765M 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. Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses. 2 Based on WAC price of $85 per 10 mg rescue dose and average 2 rescue doses per patient; $42.50 per 5 mg prophylaxis dose.

BARHEMSYS® is the Only FDA-Approved Product for PONV Rescue

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%

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-minute reduction in PACU stay

  • 6-hour reduction in hospital stay

  • Offers significant economic savings to hospital vs current standard of care

Convenient, easy to use, high margin product

  • 5-year room 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 (recovery room) allows increased surgical throughput

  • Better efficacy and safety means better recovery and patient experience

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.

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

Field Force Design

  • 1 SVP of Field Commercial Teams

  • 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

BARHEMSYS - Robust Commercial Engagement Creating Traction

  • Robust WorseThanPain/ Disease state campaign highlighting unmet need in PONV (worsethanpain.com)

  • Medical congress engagements: ~ 400 symposia attendees and 550 leads generated

  • Peer-to-peer programs: 60+ programs with ~450 attendees (live, virtual and on demand) since launch

  • All promotional materials available both physically and digitally to meet customers needs

  • Digital brand engagements in the most trusted anesthesia publications with 89% readership (51K members)

Anaesthesia

PharmacyKey Surgeons

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

  • Surgery backlogs are major issues for US hospitals

  • Value of BARHEMSYS and BYFAVO in improving throughput facilitates our access to key decision-makers

Demonstrate unmet need, appropriate use & health economic benefit

  • Highlight current unmet needs with existing products

  • Educate on efficacy and safety data for our products

  • BARHEMSYS and BYFAVO can provide economic savings to hospital vs current standard of care

Formulary adoption and pull-through

  • P&T Committee approval typically takes 9-12 months on average

  • Protocols, standing orders and point-of-care supplies drive sales pull-through

Reviews assessment and votes to revise formulary

Pharmacy & Therapeutics Committee

Appropriate Use

Standing Orders

Point-of-Care

and Protocols

Stocking

120 accounts on formulary >85% win rate

141 additional accounts have scheduled a date for formulary review

>70 accounts have already ordered the product

38% of ordering accounts have placed repeat orders

BYFAVO

(remimazolam) for injection

Rapid onset/offset procedural sedative with favorable safety profile

Total addressable market in procedural sedation >$1.5B/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

15 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 WAC price of $39 per dose.

  • Rapid onset and offset anesthetic with narrow therapeutic index1

  • Dose-related cardiorespiratory depression, pain at injection site1

  • Non-linear dosing effects due to individual variability4

  • Needs continuous monitoring by anesthesiologist, no reversal agent2

  • Lipid formulation susceptible to bacterial contamination4

Propofol

fast acting but significant safety issues1,2

  • 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

Midazolam

better safety profile but longer onset and recovery1,2

  • 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

BYFAVO

fast acting AND favorable safety profile1,2

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.

BYFAVO - Compelling Clinical and Commercial 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

BYFAVO - Launching the First New Sedative in the US for 20 years

  • On demand promotional programming available, featuring anesthesia, GI, and pulmonary investigators

  • Full congress plan across Anesthesia, Pharmacy, and including key GI and Pulm congresses

  • All promotional materials available in both digital and physical format

  • Non-personal promotional efforts, including direct mail are being initiated

- Direct email, banner ads, paid search and expanded web site

7 accounts on

36 additional

8 accounts have

38% of ordering

formulary in eight

accounts have

already ordered

accounts have

weeks of launch

scheduled a date

the product

placed repeat

for formulary

orders

review

Financials

2020 Operating Results

Loss after tax for the year ended 31 December 2020 of $33.5m (2019: $22.8m)

  • The operating loss increased by $8.5m to $30.9m (2019: $22.4m), reflecting the investment in our US commercial infrastructure and product launch preparations

  • R&D expenses $0.1m (2019: $3.9m) with the reduction reflecting lower R&D activities on completion of BARHEMSYS clinical program, together with a $1.4m credit on reversing certain inventory provisions on the approval of BARHEMSYS

  • Sales and marketing expenses $19.4m (2019: $14.0m) reflecting increased activities leading up to the planned launch of BARHEMSYS and BYFAVO

  • General and administrative expenses $11.6m (2019: $4.4m) with 2020 costs higher as a result of fundraising activities, personnel costs and amortisation of intangibles

2020

2019

$millions

Research and development expenses

Sales and marketing expenses

General and administrative expenses

Total

Research and development expenses

Sales and marketing expenses

General and administrative expenses

Total

OPEX As reported

$ (0.1)

$ (19.4)

$ (11.6)

$ (31.1)

$ (3.9)

$ (14.0)

$ (4.4)

$ (22.4)

Inventory provision reversal

(1.4)

-

-

(1.4)

1.4

-

-

1.4

Share based compensation

0.0

1.3

1.4

2.7

0.1

1.6

0.7

2.4

Amortization*

-

-

3.1

3.1

-

-

-

-

Adjusted OPEX

$ (1.5)

$ (18.1)

$ (7.1)

$ (26.7)

$ (2.4)

$ (12.4)

$ (3.7)

$ (18.6)

Operating Loss as

Reported

$(30.9)

$(22.4)

Adjusted Operating

Loss

$(26.5)

$(18.6)

1.4

* Relates to amortization of BYFAVO intangible asset

Strengthened Financial Position

Cash Runway Extended Through Q2 2022

  • Cash and cash equivalents as of 31 December 2020 of $46.7m (2019: $17.0m)

    • - €20m (~$22m) equity investment from Cosmo as part of BYFAVO license agreement

    • -25m (~$31m) loan from Cosmo related to BYFAVO approval

    • - €25m (~$29m) equity financing in August 2020

  • Additional equity financing in February 2021 with gross proceeds of €27m (~$33m)

Summary

Our products address unmet medical needs in therapeutic areas with large total addressable market opportunities (~$2.7B in PONV rescue, >$1.5B in procedural sedation)

The team made tremendous progress in 2020 despite a very challenging operating environment due to the global pandemic

We have seen a great response from customers in the early stages of launch adding our products to formulary with positive customer feedback on both products so far

While the environment remains very dynamic, we believe we should be able to benefit from a relaxation of restrictions and a rebound in procedural volumes in the second half of this year

We believe we have the right team, with the right experience to continue to drive the successful commercial launch for both products this year

Q&A

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Acacia Pharma Group plc published this content on 29 March 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 March 2021 08:51:08 UTC.