20.07.30 Chairman's Address and Longmile Presentation · 2020. 10. 20. · Factor Therapeutics...

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Factor Therapeutics Limited ABN: 45 101 955 088 C/- Company Matters Pty Limited, Level 21, 10 Eagle Street, Brisbane QLD 4000 P: +61 7 3334 3900 W: www.factor-therapeutics.com Factor Therapeutics 2020 Annual General Meeting Chairman’s Address and Shareholder presentation on LONGMILE opportunity Brisbane (Australia), 30 July 2020: Factor Therapeutics Limited (ASX: FTT) is pleased to provide the Chairman’s Address to the 2020 Annual General Meeting of Shareholders being held today at 10.00am (AEST) as a virtual AGM via: https://agmlive.link/FTT20. The Company also provides a presentation on the LONGMILE opportunity, further to the Company’s announcement on 24 July 2020 on having entered into a term sheet to acquire products and technologies for companion animal and equine veterinary imaging from LONGMILE, which will be presented to the AGM by Non-executive Director, Dr Christian Behrenbruch. ADDRESS TO SHAREHOLDERS BY DR CHERRELL HIRST, AO, CHAIRMAN Good morning Shareholders and Colleagues. Welcome to this 2020 AGM of Factor Therapeutics. It is good to have so many Shareholders present and an additional thank you to those Shareholders not in attendance who have cast their proxy votes. As Factor’s Chairman, I am pleased to address you on the key matters of the year. We live in uncertain times given the impact of the pandemic on our social frameworks and our economy. I trust you are staying well and managing the considerable challenges we each face during this time. As stated in our directors’ report released last week the COVID-19 crisis has not materially affected the financial results for the half-year to 30 June 2020, although clearly it has not been a climate that is highly conducive to closing new transactions, particularly for prospective assets outside of Australia. That said, we have persisted through the impediments posed by travel restrictions and the ability to engage face-to-face, and an important part of our presentation to Shareholders today reflects this. Today is a milestone for all of us. We are at the stage where we are able to articulate what we believe to be a compelling future for the Company through the proposed transaction with Long Mile Veterinary Imaging. We have repeatedly indicated through periodic shareholder updates and also at our AGM/EGM in March of 2019 that we were committed to on-boarding a suitable and compelling opportunity with the potential to set the future trajectory of the business. It has taken a long time – far longer than any of us on the board imagined and far longer than many of you imagined, I’m sure. However, this is reflective of both the high bar that we have set in terms of determining the scope and suitability of an opportunity, as well as the time and effort required to comprehensively diligence potential new business opportunities. We have considered over thirty possible opportunities over the last 18 months and, despite several promising candidates, we were not sufficiently enamoured to enter into a definitive transaction process. We have always focused on three considerations – proximity to commercial activity, market impediments to success and the ability for a deal to effectively harness the Company’s current financial resources, at least in the near term. The deal that we have structured with LONGMILE and for which we have committed to an exclusivity “no talk / no shop” period in order to complete DD and prepare final documents meets those criteria which are:

Transcript of 20.07.30 Chairman's Address and Longmile Presentation · 2020. 10. 20. · Factor Therapeutics...

Page 1: 20.07.30 Chairman's Address and Longmile Presentation · 2020. 10. 20. · Factor Therapeutics Limited ABN: 45 101 955 088 C/- Company Matters Pty Limited, Level 21, 10 Eagle Street,

Factor Therapeutics Limited ABN: 45 101 955 088 C/- Company Matters Pty Limited, Level 21, 10 Eagle Street, Brisbane QLD 4000

P: +61 7 3334 3900 W: www.factor-therapeutics.com

Factor Therapeutics 2020 Annual General Meeting

Chairman’s Address and Shareholder presentation on LONGMILE opportunity

Brisbane (Australia), 30 July 2020: Factor Therapeutics Limited (ASX: FTT) is pleased to provide the Chairman’s Address to the 2020 Annual General Meeting of Shareholders being held today at 10.00am (AEST) as a virtual AGM via: https://agmlive.link/FTT20. The Company also provides a presentation on the LONGMILE opportunity, further to the Company’s announcement on 24 July 2020 on having entered into a term sheet to acquire products and technologies for companion animal and equine veterinary imaging from LONGMILE, which will be presented to the AGM by Non-executive Director, Dr Christian Behrenbruch.

ADDRESS TO SHAREHOLDERS BY DR CHERRELL HIRST, AO, CHAIRMAN Good morning Shareholders and Colleagues. Welcome to this 2020 AGM of Factor Therapeutics. It is good to have so many Shareholders present and an additional thank you to those Shareholders not in attendance who have cast their proxy votes. As Factor’s Chairman, I am pleased to address you on the key matters of the year. We live in uncertain times given the impact of the pandemic on our social frameworks and our economy. I trust you are staying well and managing the considerable challenges we each face during this time. As stated in our directors’ report released last week the COVID-19 crisis has not materially affected the financial results for the half-year to 30 June 2020, although clearly it has not been a climate that is highly conducive to closing new transactions, particularly for prospective assets outside of Australia. That said, we have persisted through the impediments posed by travel restrictions and the ability to engage face-to-face, and an important part of our presentation to Shareholders today reflects this. Today is a milestone for all of us. We are at the stage where we are able to articulate what we believe to be a compelling future for the Company through the proposed transaction with Long Mile Veterinary Imaging. We have repeatedly indicated through periodic shareholder updates and also at our AGM/EGM in March of 2019 that we were committed to on-boarding a suitable and compelling opportunity with the potential to set the future trajectory of the business. It has taken a long time – far longer than any of us on the board imagined and far longer than many of you imagined, I’m sure. However, this is reflective of both the high bar that we have set in terms of determining the scope and suitability of an opportunity, as well as the time and effort required to comprehensively diligence potential new business opportunities. We have considered over thirty possible opportunities over the last 18 months and, despite several promising candidates, we were not sufficiently enamoured to enter into a definitive transaction process. We have always focused on three considerations – proximity to commercial activity, market impediments to success and the ability for a deal to effectively harness the Company’s current financial resources, at least in the near term. The deal that we have structured with LONGMILE and for which we have committed to an exclusivity “no talk / no shop” period in order to complete DD and prepare final documents meets those criteria which are:

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Factor Therapeutics Limited ABN: 45 101 955 088 C/- Company Matters Pty Limited, Level 21, 10 Eagle Street, Brisbane QLD 4000

P: +61 7 3334 3900 W: www.factor-therapeutics.com

• clear scientific and technical rationale: the intellectual property and domain

knowledge necessary for success • commercial potential: compelling target market size, product differentiation,

competition, potential for reimbursement or a clear payor dynamic, and regulatory impediments

• path to market: current stage of development, activities required to progress, timeframe to reach commercially meaningful inflection points

• financial position: immediate capital needs as well as the longer-term financial requirements of the business

• team: management team experience and track record. Our asset diligence activity has generally involved evaluating significant pre-clinical and clinical data sets, conducting IP reviews, engaging with key opinion leaders and customers, reviewing manufacturing packages and even background/credential checks. This is time-consuming activity and I would like to acknowledge the very long hours that the team has put in, often across many time zones, to conduct this activity. I’d like to acknowledge your patience: we are aware that many of our Shareholders have become inpatient and frustrated. We came close to signing a term sheet on three prior occasions but on each occasion, we elected to walk away, either because of discordance in valuation expectations or preliminary diligence concerns that we were unable to move past. For the Factor team, it has certainly has not been about doing just any deal. Over the last 18 months, and I hope it is evident, we have been judicious in the deployment of the Company’s financial resources demonstrated by our strong financial position as at 30th June 2020 and the disclosed details of our expenditure. Our 2020 Year End audited accounts were released yesterday. We have kept costs to a minimum and we have leveraged the expertise of the board to conduct diligence activities, rather than primarily out-source diligence activity, although external experts have been retained where needed. Our goal has been to keep our capital as intact as possible to maximise the possibility that your Company has the financial resources to kick-start a new commercial opportunity. As I have stated, your directors are very positive about the potential of the Long Mile opportunity. My three colleagues, who are proposed to continue as directors, are committed to bringing this transaction to fruition – through the proposed implementation period and into the years that follow. Despite the lack of international travel, we have had considerable interaction with our colleagues at Long Mile and I can assure you that they are as engaged and enthusiastic as we are. Chris will provide more detail regarding this opportunity in the presentation which will follow this address and you will have the chance to ask questions. To our collective frustration the ASX has placed FTT in suspension, with the only binding commitment entered into being for exclusivity to negotiate the final details of the purchase agreement with Long Mile, subject to very specific areas of diligence. The ASX have determined that Shareholders are not, at this time, fully informed as to the details of the transaction. This is a conundrum because the term sheet we have negotiated is highly detailed but there is the possibility that the transaction structure will vary as a function of completion diligence, conditions precedent and any structural restrictions imposed by the ASX. Furthermore, the ASX has ruled that because Factor has effectively been a “cash box” since ceasing prior operations that we must meet the requirements of Chapters 11 of the listing rules and re-compliance with Chapters 1 and 2 before the suspension will be lifted. We see this as an achievable objective for this transaction and we are prepared, collectively, to do the hard work that will be required. However, it does require a degree of shareholder understanding and patience that these compliance hurdles will be required whatever the transaction we elect to pursue.

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Factor Therapeutics Limited ABN: 45 101 955 088 C/- Company Matters Pty Limited, Level 21, 10 Eagle Street, Brisbane QLD 4000

P: +61 7 3334 3900 W: www.factor-therapeutics.com

The Long Mile transaction is complicated because it involves both the acquisition of a business unit, as well as establishing an ongoing manufacturing and innovation partnership with Long Mile’s parent company. Although we have completed much of the preliminary diligence and valuation analysis, there is a considerable amount of detail to be hammered out in the various governing agreements around the transaction. This is why we have established a timeline of 120 days to achieve a definitive purchase agreement and related ancillary agreements. I would suggest, based on the amount of work to be done for a transaction of this nature, this is not an overly generous duration. We are, however, committed – collectively – to getting the transaction done at, or before, the 120 day period and when the final terms and conditions-precedent (many of which relate to the business structure) of the transaction are complete, we will return to Shareholders for your vote based on a full set of detailed and transparent terms. For the avoidance of doubt we have, on a regular basis, considered whether the best course of action would simply be to return capital to Shareholders. But our present position is that we have a genuine opportunity to generate significant value for our Shareholders that leverages our balance sheet and the significant expertise in the Board. Certainly, messages received from our larger Shareholders have been to encourage us to find a new opportunity for the Company. Also, for clarity, although we have primarily considered opportunities in the life sciences, biotech and medtech, we have also considered proposals outside of our immediate field of expertise with the clear understanding that a transaction based on a non-healthcare opportunity would require a completely new Board. We have been open to non-life sciences opportunities providing they come with a strong management team that could in our view, generate value for Shareholders. To date such opportunities have been speculative at best and opportunistic at worst. Finally, in conjunction with the transaction announcement, we have also announced that I will be retiring from the Factor Board at the close of this meeting. Back in November 2018, I was ready to step down on the announcement of positive trial results. Sadly, that was not to be and I have stayed on as Chair, committed to be part of bringing to you an opportunity for the future. In some ways, I wish I could be a part of the Company’s exciting future but the energy to implement a major new business plan diminishes with age and I am ready to retire. I wish you all well and thank you for your support over many years. Thank you to my fellow directors and to Mel our Company Secretary for your committed and tireless work for Factor over your time on the Board but especially over the last two years. I am now going to ask Dr Christian Behrenbruch to take you through the transaction presentation on behalf of the Factor Directors. After Chris’s presentation, we will take general questions about the transaction, to the extent we can answer them, and then move to the formal agenda of the meeting.

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AGM 2020

Factor Therapeutics Limited

LongmileOpportunity

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Deal evaluation

Criteria applied to new opportunities:

1. Unique and differentiated value proposition

2. At, or feasibly close, to generating commercial revenues

3. Minimal further development required; utility of technology established

4. Near-term commercial inflection points achievable with existing capital

5. No major regulatory impediments to achieving commercial success

Significant undertaking by the Factor team:

• 30+ projects/assets considered

• 10+ taken into full evaluation

• 4 opportunities advanced into a detailed due diligence process and term

sheet negotiation (including LONGMILE)

30+

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LONGMILE – Bringing PET imaging to vets

LONGMILE has developed the world’s first portable, commercial

PET (positron emission tomography) scanner optimized for

veterinary use. Currently PET scanning is used almost

extensively for human health:

• Provides unique, 3D biological information

• Function/activity v structure (X-ray, CT, MRI)

• Ideal for detecting active injury sites and tumour activity

Use of PET scanning for veterinary applications has been limited:

• Instruments large, expensive, fixed installation

• Require 3-phase power supply and extensive cooling systems

• Not ideal for use with animals (size, access, soiling)

Vast majority of vets do not have access to PET scanning. The few

that do typically use refurbished human scanners

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Designed for vets – “PET for Pets”

Human PET scanner LONGMILE’s MILE-PET® LONGMILE’s πPET®

• Large installation footprint, $$$

• Not ideal for imaging animals

• $Bn market (CAGR 5-6%1)

• Completely portable

• Designed for standing animals

without anesthesia

• Elite, niche market that will drive

further innovation & adoption

• Completely portable

• No expensive infrastructure

• Range of form factors possible

• Large, unmet clinical need

1Data Intelligence, Positron-Emission Tomography (PET) Market, Size, Share, Opportunities and Forecast, 2020-2027

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Slide - 5 -

MILE-PET® scanner – optimised for equestrian sports

LONGMILE’S MILE-PET scanner is designed to provide easy, safe

PET scanning of horses for possible leg injuries:

• Portable

• Standing position, no anaesthesia

• Imaging chamber opens and closes

• Movement-compensating algorithms

• Potential to expand into other livestock applications

Unique market opportunity:

• Elite, high-performance validation

• Strong economic and ethical drivers for adoption

• High value benefit for customers

• High profile customer base to drive awareness

• No directly competing product in the market

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Slide - 6 -

MILE-PET – provides unique and important information

Data from MILE-PET scans allows owners and vets to make

more informed decisions regarding equine health:

✓ Measures and locates specific biological activities

✓ Provides high-resolution imaging data

✓ Can combine with structural data from X-ray, CT and MRI

✓ Earlier detection of injury

✓ Detects injuries missed using other imaging modalities

✓ Distinguishes new, active injuries from old, scarred injuries

✓ Can be used for imaging soft tissues (tendons) as well as bone

providing maximum clinical utilityCombined PET and CT images of foot region in 20yr old thoroughbredSOURCE: The Equine Chronicle, October 2016

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Slide - 7 -

MILE-PET – Ready for commercial roll-out

Leading luminary sites are already using MILE-PET :

• University of California Davis – School of Veterinary Medicine

• Santa Anita Raceway (California, USA)

• University of Pennsylvania – New Bolton Center

✓ Extensive field experience with >1000 scans conducted to date

✓ Multiple publications in peer-reviewed journals with more on the way

✓ Robust pipeline of qualified customers ready to adopt MILE-PET

✓ No additional regulatory clearances or approvals required

✓ Revenues from MILE-PET have already commenced

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Slide - 8 -

πPET® – Companion animal market for future growth

The small size and portability of LONGMILE’s πPET device makes PET

scanning readily available for the companion animal market

As with humans, PET scans of companion animals are highly informative for:

✓ Cancer diagnosis / staging

✓ Surgical planning

✓ Tissue injury / lameness

Vast majority of veterinary practices do not have access to a PET scanner

Those that do are typically using refurbished human scanners:

• High running costs with typically limited support/replacement parts

• Not optimized for animals (bore size, image quality, cleaning, etc.)

• Limited adoption potential

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Slide - 9 -

πPET – Commercial release in 2H 2021

PET technology provided in a format optimized for mainstream vet use:

• Low cost, portable; opportunity to provide mobile imaging service

• Specifically designed for use with companion animals

• Unique IP to maximise image quality, deal with subject motion

✓ Advanced working prototypes in production with early use by KOLs*

✓ Software for use of PET/CT by veterinary oncologists in development

✓ FDA oversight, but does not require 510(k), PMA, or any other pre-market

approval for use with animals

✓ Large market: US companion animal market, 77M dogs, 58M cats

✓ Commercial opportunity aligned with rapid growth in pet insurance

coverage

*KOL = Key Opinion Leader

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Slide - 10 -

Building the team

David Beylin – Co-founder and current CEO

• Will join the post-merger company as CEO

• Ex-Program Director of Small Business Innovation at NIH, X/Seed Capital

• Ex-Vice President of R&D at Naviscan PET Systems, Inc.

• Board-certified Nuclear Medicine Physicist

Australia-based GM and Chief Veterinary Officer (CVO)

• High-calibre candidate engaged (subject to finalization of the transaction)

• Recognised leader in the field of veterinary medicine, equine health

Board of Directors

• David Brookes (Chairman), John Michailidis, Christian Behrenbruch to remain

• Two board members to join from LONGMILE team on completion

Veterinary Advisory Board (VAB)

• Outstanding advisory board in place, will be augmented to include Australian KOLs For illustration purposes only. Chris Brown will not be joining the company

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Slide - 11 -

Deal structure

Proposed transaction

• Acquisition of the LONGMILE division of Brain Biosciences, Inc. (parent company)

• Initial diligence completed, detailed term sheet in place (deal structure, team,

manufacturing, ongoing innovation plan, etc.)

• Scrip-based acquisition: cash preserved to fund commercialisation and growth

• Deal structure to include some deferred consideration based on forecast sales targets

(negotiated, but subject to final diligence)

• Tax-related matters may impact final transaction structure

Ongoing operating agreements

• Manufacture and supply agreement to remain in place with parent company

• Long-term innovation plan to further leverage differentiated technology platform

Right of First Refusal (ROFR) over the human business

• Deal includes the potential to encompass human applications for the technology

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Slide - 12 -

Transaction timelines

Both parties committed to getting the deal done, high level of engagement

• Negotiated exclusive, 120-day timeframe to conclude the transaction:

• complete remaining due diligence matters

• conclude deal structure, incorporating input from regulator

• negotiate ancillary contracts (manufacturing, innovation etc)

• accommodate impact of COVID-19 pandemic

• FTT has agreed to pay US$25,000 up-front and an additional $25,000 upon execution

of a definitive purchase agreement

• Period should be sufficient to meet the ASX/compliance aspects of the transaction

• ASX has indicated that FTT is likely to be required to undertake a recompliance listing

for any transaction of this nature

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Slide - 13 -

Opportunity summary

Unique, world-first – small footprint, portable PET scanner

• MILE-PET® for equine injury assessment:

✓ First revenues, high profile exposure in elite

performance market (the “Formula 1”)

✓ Equine application drives the technology

• πPET® for companion animals (the “Prius”):

✓ Unmet need for veterinary medicine

✓ Large addressable market

✓ Product launch scheduled for 2H 2021

• Technology and product platform significantly de-risked

• Validated through extensive field use and publications

• No major regulatory hurdles or approvals required

• Commercial-stage opportunity

Slide - 13 -

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Questions