Annual Report 2022 – 2023
HOPE IS ON THE HORIZON
Our cover
Our lead drug candidate Sozinibercept
(OPT-302) has the potential to become
the first selective VEGF–C/D inhibitor
for the treatment of wet AMD.
Contents
01
About Opthea
02
Our Journey
04
Sozinibercept Progressing in Global wet AMD Phase 3 Trials
06
Dr. Charles Wykoff
08
Professor Timothy Jackson
10
Chairman’s Letter
12
CEO’s Letter
13
Forward-looking Statements
14
Environmental, Social and Governance
20
Directors’ Report
47
Management Team
50
Financial Report
100 Corporate Directory
Opthea Limited
ABOUT
OPTHEA
Opthea is a clinical stage biopharmaceutical
company committed to developing innovative
therapies to improve vision in patients with retinal
eye diseases. With an established foundation in
Australia and expanded presence in the United
States following our listing on the NASDAQ stock
exchange in October 2020, we are well positioned
to advance our lead therapeutic candidate
sozinibercept (OPT‑302) through Phase 3 clinical
trials in support of future registration filings for
marketing approval and commercialization.
Our first‑in‑class novel therapeutic called
sozinibercept (OPT‑302), is a VEGF‑C/D “trap”,
to be used in combination with standard of care
anti‑VEGF‑A therapies to improve vision in patients,
many of whom respond sub‑optimally or become
refractory to existing treatments.
Millions of people around the world suffer from
impaired vision as a result of the aging process.
With limited treatment options currently available
for patients, and a large unmet medical need, our
mission is to expeditiously develop our therapies
to improve visual outcomes for patients, leading
to better quality of life.
OUR VISION
Advancing bold therapeutic
innovation and inspiring
transformation in the global
retinal community
OUR MISSION
Dedicated to improving and
protecting vision in people with
retinal diseases
Annual Report 2022 – 2023
01
OUR
JOURNEY
Circadian
Technologies
listed on the
Australian Securities
Exchange in 1985.
Circadian focused
its strategy to
concentrate on the
development of
biologics-based
therapies.
The company
was renamed
Opthea Limited and
began developing
OPT-302 for retinal
eye diseases.
Initiated Phase
1/2A Clinical Trial
in wet AMD.
Opthea announces
positive data from
a Phase 2b trial of
OPT-302 in patients
with wet AMD.
Opthea began
trading on the
Nasdaq under the
ticker symbol “OPT.”
Announced results
of Phase 2 Clinical
Trial in Diabetic
Macular Edema.
1985
2020
20 0 8
2015
2019
1
2
02
Opthea Limited
Initiated Phase 3
ShORe and COAST
Clinical Trials
in wet AMD.
Opthea executed a
non-dilutive financing
transaction for up
to US$170 million
from Carlyle and
Abingworth.
2021
2022
TRIAL HIG HLIG HTS
3
Continued to execute on
global patient recruitment
strategies in North America,
Europe, Asia Pacific
and Latin America with
enhanced site and physician
engagement to advance
sozinibercept ShORe and
COAST Phase 3 clinical
studies in wet AMD.
Achieved approximately
75% patient enrolment in
our Phase 3 clinical trials in
August 2023. We anticipate
completion of patient
enrolment for COAST
and ShORe in the first and
second quarter of calendar
year 2024 respectively.
Maintained our commitment
to strong engagement with
the international retina
clinical communities by
actively participating and
presenting at important
clinical and corporate
meetings, symposia and
events, including the
American Academy of
Ophthalmology (AAO),
EURetina, Ophthalmology
Innovation Summit (OIS),
American Society Retina
Specialists (ASRS), and
FLOretina conferences.
Added new appointments
to further strengthen the
leadership team, Board
of Directors and global
operations supporting the
pivotal Phase 3 program.
Published Opthea’s Phase 2b
study results of combination
sozinibercept with Lucentis®
(ranibizumab) for the
treatment of wet age-related
macular degeneration in
Ophthalmology, the leading
peer-reviewed journal
of the American Academy
of Ophthalmology.
Advanced manufacturing,
non-clinical toxicology and
bioanalytical regulatory
studies in support of the
ongoing Phase 3 clinical
trials, planned BLA filing and
future commercial launch
for sozinibercept which has
Fast-Track Designation from
the FDA for wet AMD.
Successfully completed
a non-dilutive financing
transaction for up to
US$170 million and a
US$90 million equity
financing, bolstering Opthea’s
financial and strategic
position to maximize the
value of sozinibercept.
The two pivotal OPT-302
Phase 3 clinical trials each
have over 185 activated
sites globally.
Approximately 35 countries
around the world are
recruiting treatment
naive patients for our
Phase 3 program.
F Y22–23 HIG HLIG HTS
Annual Report 2022 – 2023
03
Wet AMD affects over 3.5 million people
in the US and Europe. Sozinibercept
(OPT-302) has demonstrated meaningful,
improved visual outcomes in its Phase 2b
studies. These results bring us closer to
helping a large and growing wet AMD
population.
We are progressing our two concurrent, global, randomized,
sham-controlled Phase 3 clinical studies:
•
ShORe: Study of sozinibercept (OPT-302) in combination
with Ranibizumab; and
•
COAST: Combination sozinibercept (OPT-302) with
Aflibercept STudy.
The ShORe and COAST Phase 3 trials build upon and
maintain key features of our successful Phase 2b clinical
trial of sozinibercept combination therapy for the treatment
of wet AMD. Both Phase 3 studies evaluate sozinibercept
as a combination therapy over a 52-week treatment period,
each with 990 patients.
The primary endpoint of the Phase 3 studies is the mean
change in best corrected visual acuity (BCVA) from baseline
to week 52 for sozinibercept combination therapy compared
to standard of care anti‑VEGF‑A monotherapy.
Why sozinibercept?
Current standard of care treatments for wet AMD are largely
limited to VEGF-A inhibitors such as ranibizumab (Lucentis®)
or aflibercept (Eylea®). These standard of care treatments are
administered monthly or every other month by intravitreal
injection. Although patients are offered some vision benefit,
most patients fail to achieve sufficient vision gains to resume
routine daily activities such as driving and reading. Often wet
AMD patients experience further vision loss after 12 months.
Recent and current clinical trials in the wet AMD landscape
have focused on achieving increased durability of therapy,
measured by longer treatment intervals, without aiming
to improve visual outcomes. By contrast, our successfully
completed Phase 2b study data has demonstrated
sozinibercept (OPT-302) combination therapy offers
superior vision gain over the current standard of care
for wet AMD with comparable safety.
The design of ShORe and COAST have been optimized based
on Phase 2b outcomes to maximize probability of success
and commercial opportunity for sozinibercept (OPT-302).
Recruitment for Phase 3 studies
We have been actively recruiting patients globally for
participation in both ShORe and COAST Phase 3 studies.
As of August 2023, over 185 clinical trial sites for each
study have been activated in the United States (“US”),
Canada, Europe Asia Pacific and Latin America.
Over the next year, we will continue to work with a global
Clinical Research Organization or “CRO” to complete patient
recruitment with a target completion of patient enrolment
for COAST in the first quarter of calendar year 2024
and for ShORe in the second quarter of calendar 2024.
Completing Phase 3 studies
The ShORe and COAST studies are both double‑masked,
sham‑controlled Phase 3 registrational trials to evaluate
efficacy and safety of intravitreal 2.0 mg sozinibercept
in combination with either 0.5 mg ranibizumab (Lucentis®),
or 2.0 mg aflibercept (Eylea®) respectively.
Each study will investigate the mean change in best
corrected visual acuity from baseline to week-52 for
sozinibercept combination therapy versus standard of
care anti-VEGF-A monotherapy alone. Topline data for
the primary endpoint is expected to be reported when
all patients complete the 52-week treatment period
and the results are collected, analyzed and verified.
If the topline results at the completion of the primary efficacy
phase are favorable, we intend to file for marketing approval
for sozinibercept for the treatment of wet AMD in the US
as a priority followed by filing in the European Union (“EU”).
SOZINIBERCEPT
PROGRESSING IN GLOBAL
WET AMD PHASE 3 TRIALS
04
Opthea Limited
Fast-Track development timeline
Superior Phase 2b results led to the US FDA granting Fast-Track
designation to sozinibercept as a combination therapy for the
treatment of patients with wet AMD. Fast-Track designation
is designed to expedite drug development and review to get
important new therapies with an unmet medical need to
patients more quickly. If our Phase 3 trials are successful,
Opthea plans to file Biologics License and Marketing
Authorization Applications with regulatory agencies
in the US and the EU respectively.
Commercial advantages
Investigation of sozinibercept (OPT-302) as a combination
therapy with two leading standard of care treatments
may position sozinibercept as a complementary treatment
for administration with any VEGF-A inhibitor. Importantly,
our Phase 3 trials ShORe and COAST are designed to
demonstrate superior visual acuity outcomes of sozinibercept
combination treatment over standard of care anti-VEGF-A
monotherapy. This approach differentiates Opthea’s clinical
development program from the majority of other clinical
programs for wet AMD which are mainly focused on
demonstrating durability of anti-VEGF-A therapy to reduce
treatment burden.
Efficacy Phase
Safety Phase
Efficacy Phase
Primary Efficacy
Endpoint Week 52
Safety Follow–up
Week 100
Ranibizumab (0.5 mg) + Sham
IVT q4w x 52 wks
Ranibizumab (0.5 mg) IVT q4w x 52 wks
+ Sozinibercept (2.0 mg) IVT q4w x 12 wks; q8w x 40 wks
Ranibizumab (0.5 mg) + Sozinibercept (2.0 mg)
IVT q4w x 52 wks
ShORe Trial
Design
WET AMD
Tx Naïve Pts
Safety Phase
Ranibizumab (0.5 mg) + Sham
Ranibizumab (0.5 mg) + Sozinibercept (2.0 mg)
Ranibizumab (0.5 mg) + Sozinibercept (2.0 mg)
Primary Efficacy
Endpoint Week 52
Safety Follow–up
Week 100
Aflibercept (2.0 mg) + Sham
IVT q4w x 12 wks; q8w x 40wks
Aflibercept (2.0 mg) + Sozinibercept (2.0 mg)
IVT q4w x 12 wks; q8w x 40wks
Aflibercept (2.0 mg) IVT q4w x 12 wks
+ Sozinibercept (2.0 mg) IVT q4w x 52 wks; q8w x 40wks
WET AMD
Tx Naïve Pts
Aflibercept (2.0 mg) + Sham
Aflibercept (2.0 mg)) + Sozinibercept (2.0 mg)
Aflibercept (2.0 mg) + Sozinibercept (2.0 mg)
COAST Trial
Design
A global Phase 3 program
The two pivotal sozinibercept (OPT-302) Phase 3
clinical trials each have over 185 clinical trial sites
activated globally. ShORe and COAST are currently
recruiting patients with treatment naïve wet AMD
in approximately 35 countries around the world.
Annual Report 2022 – 2023
05
DR. CHARLES
WYKOFF
Chief Investigator
Phase 3 COAST Study
Q: Could you provide an overview of your background?
I am a medical and surgical retina specialist based in Houston,
Texas. Upon completing both my MD and PhD, I decided to
pursue a career in clinical research. I am actively involved in
leading clinical trials as part of Retina Consultants of Texas,
and I lead the Research Committee for Retina Consultants
of America, representing over 250 retina specialists
across the US. I also hold the position of Deputy Chair
of Ophthalmology and serve as an Associate Clinical
Professor at Blanton Eye Institute, which is affiliated
with Weill Cornell Medical School.
Q: Briefly characterize your current clinical
practice setting?
In my practice of about 20 retina specialists, we focus
entirely on vitreoretinal diseases seeing on average
60 patients per day. We see a variety of cases including
those requiring surgical procedures. In addition, many of
our patients receive routine anti-VEGF-A injections, which
work effectively but require ongoing treatment. A significant
portion of our practice comprises patients requiring these
chronic anti-VEGF-A injections.
Q: How do your patients react to being diagnosed
with wet AMD?
When delivering the diagnosis of wet AMD, the reactions
from patients vary. Most patients are anxious and have
heard about the condition from friends or family. Many are
concerned about the possibility of blindness and some fear
the treatment itself. We must understand and address this
fear in order to most appropriately help the patient.
When discussing treatment options, patients value
the prospect of visual improvement, which brings hope.
Even if visual acuity only shifts slightly, it can have
a meaningful impact on individual patients.
Q: From your perspective what is the current
unmet need in wet AMD?
There are two common unmet needs actively being investigated
in ongoing wet AMD trials that are also relevant to many other
exudative retinal diseases. The first is identifying new targets
that can complement, enhance or extend the effects of VEGF-A
inhibitors, and the second is treatment burden. Addressing
these needs is crucial for advancing treatments and improving
outcomes for patients with wet AMD. Ultimately, when you
talk to patients, the overarching focus is that they want to
see better, and many are actually willing to accept a greater
treatment burden to optimize their visual function.
Q: Are there current limitations to the current
standard of care?
Anti-VEGF-A monotherapy is the standard of care in wet
AMD, which requires frequent injections, leading to a high
treatment burden in many patients. Patients often switch
between different anti-VEGF-A therapies in pursuit of better
outcomes. The high rate of switching, around 40%, indicates
an unmet need for improved treatment options that optimize
vision for patients. Improved visual gain remains a significant
unmet need, and while the field is actively exploring
new molecular targets, no other approved target has
demonstrated the ability to add additional vision beyond
simple VEGF-A inhibition. Addressing these limitations is
crucial to providing more effective and less burdensome
treatments for patients with wet AMD.
How prevalent is wet AMD
in your practice?
Question
From the average of 60 patients per day, up to 12
would be new cases. From the remainder, about
70% are going to be patients that are receiving
injections for a chronic condition like wet AMD and
other conditions. It’s a large bulk of our practice,
and I think that’s pretty consistent across the US.
Dr Wykoff
06
Opthea Limited
Q: How long have you been involved with sozinibercept
(OPT-302) and what excites you about the therapy?
Sozinibercept (OPT-302) is an extremely exciting program to
me. I’ve been involved since 2018, and what excites me the
most is its potential to add vision to the current standard of
care for wet AMD patients worldwide. It’s the only program
in late-stage development that aims to truly enhance visual
function in combination with maximal VEGF-A suppression
by blocking additional relevant cytokines in patients.
While many other treatments focus on durability the
sozinibercept (OPT-302) trials seek to demonstrate a further
gain in visual function. Fully blocking the VEGF-A, -C and -D
signalling pathways may offer the most optimized treatment
for wet AMD patients to preserve and improve vision.
It’s a challenging endeavour, but if successful, it would bring
significant value to the field and greatly benefit patients
with wet AMD.
Q: What are your thoughts on the completed and
ongoing clinical trials for sozinibercept (OPT-302)?
Sozinibercept (OPT-302) has the most compelling efficacy
data seen in wet AMD on top of the standard of care.
The Phase 2b trial data showed a meaningful improvement
in visual acuity with sozinibercept (OPT-302) in addition to
ranibizumab. The Phase 3 trial designs are superiority trials
over standard of care alone to show maximum benefit of
blocking multiple members of the vascular endothelial growth
factor (VEGF) signalling pathway. The Phase 3 trials are more
challenging due to the high bar for superiority, aiming to
gain more visual function. This new mechanism of action
holds great potential to improve visual outcomes
for wet AMD patients.
Q: Could you comment on using an additional
injection of sozinibercept (OPT-302) for the potential
management of patients in your practice?
In my practice, we already routinely and successfully
manage two sequential injections on the same day for
other medications. Potentially incorporating sozinibercept
(OPT-302) into our routine flow appears quite feasible.
Sozinibercept (OPT-302) has demonstrated a well-tolerated
safety profile to date, comparable to standard of care.
While it requires some additional preparation, I believe it has
potential to be a meaningful addition to our treatment options.
Q: Can you comment on the designs of the
sozinibercept (OPT-302) Phase 3 clinical trials?
The Opthea team’s efforts to create a Phase 3 program with
global participation, showcases their dedication and ability
to execute these ambitious studies. The decision to have
two separate trials, one with aflibercept and the other with
ranibizumab in the Phase 3 trial was a strong and confident
move, demonstrating that sozinibercept (OPT-302) aims
to be effective with any anti-VEGF-A agent.
While some patients may be interested in participating
in this clinical trial, these trials were intentionally designed
to enrol patients with meaningful vision loss to assess the
full benefit of sozinibercept (OPT-302) in combination with
VEGF-A inhibition. However, the hypothesis is that all
patients with wet AMD would benefit from combination
therapy if the trial is successful. The trial’s design ensures
meaningful data interpretation while expecting broad
applicability for all wet AMD patients.
Q: How does the sozinibercept (OPT-302) Phase 3
program compare with other wet AMD studies you
have been involved in?
The Phase 3 program for sozinibercept (OPT-302) stands out
from other wet AMD studies I’ve been involved in because
it offers a compelling efficacy-related value proposition to
patients. The trial’s objective of improving vision through
a combination therapy with the current standard of care
resonates well with patients. They are eager to participate, as
many patients find the idea of contributing to a greater good
and advancing medical knowledge powerful and meaningful.
The Phase 3 trials for sozinibercept (OPT-302) offers patients
hope and excitement for better vision outcomes for those
suffering from wet AMD.
Q: What is your perspective on working with Opthea?
Working with the Opthea team on their global Phase 3
clinical trial program has been inspiring. In my perspective,
Opthea has a distinct personality and ethos. They have
shown a can-do attitude and a determination to punch
above their weight class. This speaks directly to the culture
and ambition of Opthea.
The Company has chosen to build their reputation
on a firm foundation of the quality of their clinical trials.
Their dedication to sound science reflects positively
on the Company and the value they bring to the field.
Q: How do you unwind away from the clinic?
When I’m away from the clinic, I focus on family. I have
three kids – one in college, one in high school and one in
middle school. Our family has a bunch of favorite quotes
including “You can do almost anything in life, just not all
at the same time.” I’m passionate about clinical trials and
program development but spending time with my family is
also a priority. We love outdoor activities like hiking, biking,
and traveling together. Recently, my youngest son and I have
taken up indoor rock climbing as a shared hobby. Balancing
work and family life brings me fulfilment and joy.
Annual Report 2022 – 2023
07
Q: Can you describe your journey to achieving
extensive experience in Ophthalmology?
After attending medical school in New Zealand, I pursued
my postgraduate ophthalmology residency and vitreoretinal
fellowship based at Moorfields Eye Hospital in the United
Kingdom (UK), along with a PhD at St Thomas’ Hospital,
London. Currently, I am Professor of Retinal Research at
King’s College London, leading undergraduate ophthalmology
teaching covering some of the big central London hospitals.
Over the past decade I’ve also contributed to the
Interventional Procedures Advisory Committee (IPAC) for
the National Institute of Health and Care Excellence (NICE),
evaluating novel device and surgical techniques.
Q: What is your day-to-day workload?
I wear three main hats. Firstly, I dedicate 50% of my time to
National Health Service (NHS) appointments and surgery,
attending to patients at Kings College Hospital. We handle
challenging cases of retinal diseases in underserved patients
from poorer inner-city areas. Secondly, I run a central London
private practice, spending a day per week on surgery and
clinics. Lastly, I devote the remaining time to an academic
position running research grants, supervising clinical PhD
students, and leading some large UK and European retinal
device and surgical trials for age-related macular
degeneration (AMD).
Q: What are the current unmet need(s) in the
management of wet AMD?
In the UK, issues stem from limited resources and the challenge
of keeping up with the increasing prevalence of this common
disease. While anti-VEGF-A therapies have shown significant
benefits compared to earlier treatments, there is a desire
for an improved approach, as patients have been on these
treatments for many years and want something new.
The goal is to find a treatment that can maintain or improve
visual acuity more effectively, providing substantial and
lasting gains, with infrequent administration, to enhance
both patient comfort and long-term vision.
When delivering a diagnosis of wet AMD to
patients, it is a deeply personal and critical moment
as a doctor. Patients arrive already suspecting
something serious due to prior symptoms and visits
to optometrists. Their main fear revolves around
going blind, and addressing this fear is essential.
In most cases, doctors can honestly reassure
patients that they will not lose all vision,
emphasizing visual acuity in the other eye.
However, it becomes more challenging when
patients are already receiving treatment for one
eye and then develop wet AMD in the fellow eye,
raising the stakes significantly.
Understanding the impact of wet AMD on patients’
lives is an ongoing challenge. Doctors discuss
treatment and visual prognosis during appointments,
but they often lack insight into the daily reality
for patients, like the frustration of being unable
to read books due to vision loss. Questionnaires and
assessments can provide further understanding, but
further research is needed to gain a comprehensive
understanding of the broader impact of wet AMD.
How do you talk with your
patients about being diagnosed
with wet AMD?
Question
Dr Tim Jackson
PROFESSOR
TIMOTHY JACKSON
Chief Investigator
Phase 3 ShORe Study
08
Opthea Limited
Q: How do you address a patient with anxieties about
treatment for wet AMD?
The anxiety surrounding wet AMD treatments can affect
how patients perceive vision gains. While gaining seven or
eight letters on an eye chart may seem substantial, it’s not an
improvement from their healthy baseline but a recovery from
previously lost vision. These patients experience a gradual
increase after losing vision suddenly. The anxiety of potential
vision loss remains even after treatment, impacting the
overall perception of improvement in quality of life.
Q: How long have you been involved with the
sozinibercept (OPT-302) clinical program?
I have been involved with the clinical development of
sozinibercept (OPT-302) since 2018. We initially participated
as a recruiting site for the Phase 2b trial in wet AMD. Since
then, the program has grown, and I find it highly fulfilling to
be part of a potential novel treatment that shows promise.
While we cannot predict the outcome of the next Phase 3
trial phase, the Phase 2b trial was crucial, as it offered the
potential for improved visual acuity, something not provided
by other treatments. The journey is ongoing, but significant
progress has been achieved so far.
Q: What is your assessment on targeting inhibition of
VEGF-C and VEGF-D with sozinibercept (OPT-302), and
the results from the Phase 2b trial in wet AMD ?
The concept of fully blocking VEGF-C and -D alongside
VEGF-A in wet AMD makes physiological and mechanistic
sense. Preclinical data has shown that suppressing VEGF-A
can lead to elevated VEGF-C and -D levels, indicating the
need for a multi-therapy approach. The phase 2B clinical trial
results were compelling, demonstrating a statistically clear
signal of efficacy. The robust trial design, of a randomized,
double-masked, and sham-controlled study, ensured
the integrity of the findings and makes the positive
outcome promising.
Q: What are your thoughts on using an additional
injection of sozinibercept (OPT-302) with
standard of care?
When I was first introduced to the idea of regular anti-VEGF-A
injections, many of us were sceptical about patient acceptance.
However, over time, we have seen that patients adapt to and
tolerate these injections well. Going from no treatment to one
injection is a significant step, whereas adding a second injection
during the same visit is much more manageable. Patients are
already prepped and accustomed to the injection process, so
an additional injection becomes less daunting. While it would
be ideal to combine the drugs into a single injection, the
efficacy demonstrated in a definitive trial would outweigh
any concerns about giving two injections. Patients prioritise
improved vision and would likely accept the convenience of
a second injection during the same visit, especially considering
the time and effort saved by avoiding multiple clinic visits.
In the UK, patients generally accept this approach for better
vision outcomes.
Q: What are your impressions of the sozinibercept
(OPT-302) Phase 3 trial designs and the recruitment
process at your clinic?
The Phase 3 trial designs for sozinibercept combination
therapy have been measured, closely mirroring the Phase 2b
trial to avoid introducing uncertainties and risks. This caution
means the trials are anticipated to yield consistent results to
the existing data.
In my clinic, we are precise in selecting eligible patients who
are likely to benefit. Recruitment has not been as difficult
as anticipated, as the prospect of a second injection has not
been a major barrier for patients. Many patients are willing
to accept the additional injection for the potential of better
visual acuity. In our selection, we aim for a successful result
that benefits patients with wet AMD.
Q: How have you found working with Opthea?
I find Opthea to be a nimble organisation with a vision and a
willingness to listen to input from clinical leads. It’s enjoyable
to be involved in decision-making processes, even if the final
decisions are not mine to make. I’ve been impressed by how
good they operate as a team.
The retina space is currently filled with dynamic research and
sozinibercept (OPT-302) is a massively positive development
in the space. A successful Phase 3 outcome will likely have
this emerging technology seen by a large audience.
Q: What gives you energy, and keeps you excited
outside of your practice?
I enjoy running twice a week, which provides a refreshing
break from the pressures of work and screen time. During
lockdown, I ran a marathon and learned sailing at a novice
level, finding joy in these new experiences. Participating
in NHS racing on a big sailing boat taught me valuable
lessons about teamwork and learning from more experienced
individuals. These activities not only enrich my life but
also influence my approach to leadership and teamwork
in the operating theatre.
Annual Report 2022 – 2023
09
CHAIRMAN’S
LETTER
The execution of the pivotal phase 3 studies of sozinibercept
remained the focus for Opthea in the 2023 fiscal year.
Despite the commercial success of several VEGF-A inhibitors,
which are considered the standard of care for patients with
Age-Related Macular Degeneration or wet AMD, more than half
of patients cannot drive, read or live independently. At Opthea
we are seeking to add sozinibercept to this standard of care
to improve vision in all patients with wet AMD.
We began the 2023 fiscal year with the completion of
a non-dilutive funding agreement with the Carlyle/Abingworth
Group to provide US$120 million for the development of
sozinibercept for the treatment of wet AMD. We are pleased
that a co-investor of Carlyle/Abingworth intends to invest
an additional US$50 million under the agreement, bringing
the total to US$170 million although this remains subject
to final diligence and receipt of regulatory and tax approvals
and we may not receive the additional US$50 million.
We continue to leverage the expertise provided by Carlyle/
Abingworth through their affiliate, Launch Therapeutics,
by working with the team for the execution of the phase 3
studies and the preparation for the completion of enrolment
and analysis of the top-line data. Alongside the funding
agreement, we raised US$90 million through an equity
financing. Subsequent to year end we raised an additional
approximately US$58 million which was supported by both
domestic and overseas institutional investors. Proceeds from
the funding agreement and the equity financings are being
used to continue to fund the phase 3 trials of sozinibercept.
Sozinibercept is currently being studied in two registrational
Phase 3 trials, ShORe and COAST, that plan to enrol nearly
2,000 patients with wet AMD. Throughout the year we
expanded our management team in the United States
with the addition of a Chief Financial Officer, several key
hires in manufacturing, quality and supply chain, and lastly
strengthened our presence with investigators and clinical
trial sites through the addition of Medical Science Liaisons
to our team.
The results from the Phase 2b study of sozinibercept
were published in a peer-reviewed journal and throughout
the year we continued to educate retina specialists and
ophthalmologists about our ongoing Phase 3 clinical studies
and the complimentary mechanism of sozinibercept to be
used in combination with standard of care for wet AMD.
Our presence at medical conferences and inclusion
in several published articles over the last year further
increased awareness of sozinibercept and its potential
to treat wet AMD patients.
In June 2023 we added Anshul Thakral, an experienced
biotech executive with deep clinical trial experience, to our
Board of Directors. Mr. Thakral replaced Michael Sistenich,
who had served on the Board of Opthea for over seven
years. Mr. Sistenich was instrumental in the growth of
Opthea, and we wish to thank him for his service and
numerous contributions over the years.
We believe the global pandemic had an impact on
our original timeline for completion of the phase 3 studies.
Based on historical and current trends we anticipate completing
enrolment in COAST in the first quarter of calendar year
2024 and in ShORe in the second quarter of calendar year
2024. Once enrolment is complete, patients will be treated
for 52 weeks, with topline data expected to be reported once
all patients have completed the 52-week dosing period and
the data verified and analyzed.
On behalf of the board and management we would like to
thank our shareholders for their support and encouragement.
We look to the future with enthusiasm and a single-minded
dedication to the objective of delivering high value, both to
patients and families of those with disorders of the eye and
to our shareholders.
Sincerely
Jeremy Levin
Board Chairman
Opthea Limited
10
Opthea Limited
“Our goal is to roll back the terrible loss of sight
for millions around the world by fundamentally
innovating treatments for AMD.”
Jeremy Levin, Chairman
Annual Report 2022 – 2023
11
CEO’S
LETTER
Dear Shareholders,
Over the last year, Opthea has remained steadfast in our
conviction to advance sozinibercept, a VEGF-C/D “trap”
inhibitor, through Phase 3 clinical trials for wet AMD.
Our conviction is based on the limitations of currently
available treatments for this highly debilitating and
progressive disease of the retina, and the understanding
that many patients continue to experience insufficient
visual acuity gains to resume routine daily activities despite
receiving ongoing and regular standard of care treatment.
Opthea’s approach to target VEGF-C and VEGF-D, and
to use sozinibercept in combination with anti-VEGF-A
therapies to more effectively block disease pathways, is
designed to deliver superior vision outcomes over those
that can be achieved with currently available treatments
that are administered alone as monotherapy.
With this in mind, Opthea has continued to focus on the
execution of our Phase 3 pivotal registration studies of
sozinibercept for the treatment of wet AMD. With the
commitment of patients around the world and the dedication
of hundreds of clinical trial sites and investigators who are
involved in our study, we were pleased to recently report
that our Phase 3 trials COAST and ShORe are approximately
75% enrolled. We continue to invest resources, time
and effort to completing patient enrolment which, as an
important milestone for the company, will see our focus
pivot to the primary ‘topline’ analysis of the outcomes
of the trials, which is expected after all patients complete
the 52-week dosing period.
With the completion of the non-dilutive Development
Funding Agreement (DFA) of US$120 million with Carlyle/
Abingworth in August 2022 and the equity funding of
US$90 million completed in parallel, we have expanded
our management team and oversight of the ShORe and
COAST studies. In completing this funding from Carlyle
and Abingworth, we have also gained access to the team
at Launch Therapeutics, who have added resources to assist
in these efforts and prepare for the analysis of results.
We continue to increase our presence with retinal specialists
and healthcare professionals through presentations and
participation at select medical conferences worldwide.
The results of Opthea’s Phase 2b study of sozinibercept
(OPT-302) in wet AMD were published in a peer-reviewed
journal in 2023 and clinical data from previously completed
trials of sozinibercept were presented on the podium at the
Ophthalmology Innovation Summit and American Society
of Retinal Specialists (ASRS) in August 2023. Recognising
the importance of continued engagement with the retinal
clinical community and our clinical trial sites, we have added
Medical Science Liaisons and additional clinical and medical
affairs team members in the United States to expand the
understanding of our Phase 3 program and potential of
sozinibercept to improve vision outcomes for patients.
Our efforts have seen an increase in the number of key
opinion leaders publishing and presenting on the importance
of sozinibercept as a late stage clinical asset with the
potential to provide better vision benefit for their patients.
Our focus for the next twelve months will be to complete
patient enrollment into both ShORe and COAST Phase 3
trials and to prepare for primary analysis and topline data
readout. We will continue to monitor our sites and patients as
they advance through our Phase 3 program and to continue
critical elements of manufacturing and commercial readiness.
Our achievements this year would not be possible without
the efforts of all our employees and the support and
guidance of our Board, the patience from our shareholders
and the dedication of many investigators and patients who
are participating in our Phase 3 program.
Thank you for your support.
Megan Baldwin PhD
CEO & Managing Director
Opthea Limited
12
Opthea Limited
FORWARD-LOOKING
STATEMENTS
Certain statements in this report may contain forward-
looking statements within the meaning of the US Private
Securities Litigation Reform Act of 1995. Any statement
describing Opthea’s goals, expectations, estimates, intentions
or beliefs is a forward-looking statement and should be
considered an at-risk statement. Forward-looking statements
in this report include statements regarding the therapeutic
and commercial potential and size of estimated market
opportunity of the Company’s product in development, the
viability of future opportunities, future market supply and
demand, the expected receipt of payments (including the
additional potential increase of US$50 million of funding
under the Development Funding Agreement (“DFA”)) and
the timing of such payments, the expected cash runway,
the expected timing of completion of patient enrollment
under the clinical trials and timing of top-line data, the
financial condition, results of operations and businesses
of Opthea, certain plans, objectives and strategies of the
management of Opthea, including with respect to the
current and planned clinical trials of its product candidate,
Opthea’s goal of building out a substantial presence in
the United States and the future performance of Opthea.
Forward-looking statements, opinions and estimates
provided in this report are based on assumptions and
contingencies which are subject to change without notice,
as are statements about market and industry trends, which
are based on interpretations of current conditions.
Forward-looking statements, including projections,
guidance on the future financial position of the Company
are provided as a general guide only and should not be relied
upon as an indication or guarantee of future performance.
They involve known and unknown risks and uncertainties
and other factors, many of which are beyond the control
of Opthea and its directors and management and may
involve significant elements of subjective judgment and
assumptions as to future events that may or may not be
correct. These statements may be affected by a range of
variables which could cause actual results or trends to differ
materially, including but not limited to the risks described
more fully in the section titled “Risk Factors” included at the
end of this report, in Opthea’s Annual Report on Form 20-F
filed with the SEC on October 28, 2022 and in the Company’s
investor presentation on Form 6-K filed with the SEC on
August 24, 2023 under “Key Risks”, including risks associated
with: the availability of funding, the receipt of funding under
the DFA (including the additional potential increase of
US$50 million of funding under the DFA), future capital
requirements, the development, testing, production,
marketing and sale of drug treatments, regulatory risk and
potential loss of regulatory approvals, ongoing clinical studies
to demonstrate OPT-302 safety, tolerability and therapeutic
efficacy, additional analysis of data from Opthea’s Phase 3
clinical trials once unmasked, timing of completion of Phase 3
clinical trial patient enrollment and CRO and labor costs,
intellectual property protections, and other factors that are
of a general nature which may affect the future operating
and financial performance of the Company. No representation,
warranty or assurance (express or implied) is given or made
in relation to any forward-looking statement by any person
(including the Company and Opthea Related Persons).
In particular, no representation, warranty or assurance
(express or implied) is given that the occurrence of the events
expressed or implied in any forward-looking statements in
this report will actually occur. Actual results, performance
or achievement may vary materially from any projections and
forward-looking statements and the assumptions on which
those statements are based. The forward-looking statements
in this report speak only as of the date of this report. Subject
to any continuing obligations under applicable law or any
relevant ASX listing rules, the Company and Opthea Related
Persons disclaim any obligation or undertaking to provide any
updates or revisions to any forward-looking statements in
this report to reflect any change in expectations in relation
to any forward-looking statements or any change in events,
conditions or circumstances on which any such statement
is based. Nothing in this report will create an implication
that there has been no change in the affairs of Opthea
since the date of this report.
Annual Report 2022 – 2023
13
What sustainability means to Opthea
As a biotechnology innovator, Opthea recognizes the
opportunity for shared value creation in developing a strong
Environmental, Social and Governance or “ESG” framework.
Our strategy is designed to align positive outcomes for
both the organization and the betterment of public health.
We do this by integrating ESG considerations across all
facets of our operations. To us, the essence of sustainability
is captured in our mission statement:
“Our mission is to expeditiously
develop our innovative
therapies to improve vision
and enhance public health
for better quality of life.”
Integrating ESG allows us to align our operations with
long-term sustainability goals, working to build responsible
research and development practices, ethical supply chains,
and positive social impacts. We believe that enhancing our
ESG policies improves our resilience and contributes to the
overall well-being of individuals and the planet.
This is our second inclusion of ESG into our reporting.
As our business matures, we intend to continue reporting
against key issues and metrics defined by the developing
International Sustainability Standards Board (ISSB) guidelines.
The goal of this reporting is to offer stakeholders concise and
reliable information regarding Opthea’s strategic focus and
future orientation. Healthcare and innovation, cornerstones
of Opthea’s business practice, are two critical elements of
sustainable development. Considering this, Opthea seeks
to offer returns with positive impact to our investors and
the global community.
With an aging global population, the prevalence of wet AMD,
a debilitating eye disease that can cause severe vision loss,
is increasing and placing a significant burden on individuals
and healthcare systems.
ENVIRONMENTAL, SOCIAL
AND GOVERNANCE
Wet AMD affects over 3.5 million people in the US and
Europe, negatively impacting the quality of life for those
affected. Addressing this issue is crucial as it not only
restores visual function and independence for individuals
but also reduces the socioeconomic impact of vision
impairment. In addition, Opthea’s research and development
contributes to advancements in the field of ophthalmology
and eye care. Our innovative approaches and scientific
discoveries can lead to a deeper understanding of the
underlying mechanisms of eye diseases and catalyze
further research and breakthroughs in the broader
scientific community.
14
Opthea Limited
ESG AT
OPTHEA
PATIENT HEALTH & SAFETY
Drug and clinical trial safety
Enhancing public health
INNOVATION
Carbon emissions
IP protection
Diversity & inclusion
ETHICS
Patient and data privacy
Animal ethics
Dealing with medical professionals
ACCESSIBILITY & AFFORDABILITY
Ensuring drug accessibility
Ensuring fair pricing
Opthea’s 4 pillars
Last year Opthea completed a materiality assessment
and stakeholder analysis to gain a comprehensive
understanding of our key ESG focus areas and to
prioritize our actions effectively. We plan to regularly
perform assessments in a continuous effort to
address those issues most important to both Opthea
and our stakeholders.
This assessment helps us focus our efforts on areas
where we can have the greatest positive impact and
to identify and mitigate risks. Understanding the issues
most important to our stakeholders allows us to better
meet expectations and develop effective and
targeted strategies. The analysis assists in aligning
our operations, products, and corporate practices
with the expectations of stakeholders, with the
ultimate goal of enhancing our overall sustainability
performance and long-term success.
Opthea has identified four ESG focus pillars, with
key issues under each. Opthea takes the approach of
double materiality, meaning we consider both issues
that affect Opthea, but also how our organization
can impact society and the environment.
Annual Report 2022 – 2023
15
Pillar 1: Patient health and safety
Drug and clinical trial safety
Drug safety is of utmost importance at Opthea. We promote
the well-being and protection of patients by minimizing
the risks and potential harm associated with medications.
We prioritize patient safety above all else, conducting
rigorous research, development, and testing of our
development products, and monitor the well-being
of our patients and the safety profile of our product.
Once commercially available, Opthea plans to disclose
quantitative measures of drug safety to offer transparency
across our drug safety record.
We have protocols in place to monitor clinical trial safety
and have adopted comprehensive guidelines for overseeing
the drug supply chain. These range from clarity over labor
practices, to environmental tracking, and serve as a measure
against counterfeiting. Monitoring the safety and efficacy of
our drugs is one of the primary methods by which Opthea
strives to enhance public health. The entire manufacturing
process is closely tracked with unique batch numbers,
tamper-resistant seals, temperature logging data, ID testing,
and quality control procedures. These procedures cover our
operations from raw material procurement to manufacturing,
packaging and shipment, labeling, and distribution.
Enhancing public health
Enhancing public health sits firmly within Opthea’s
mission and philosophy. The sustainability of our business
is mutually dependent on our ability to deliver positive
health outcomes to our patients. Our ambition is to
contribute substantially to improving vision throughout
society, and we work toward this every day through our
research and development efforts.
Pillar 2: Innovation
Carbon emissions
Opthea recognizes the urgency to reduce greenhouse
gas emissions to avoid the worsening effects of climate
change. This year we calculated our Scope 1 and 2 emissions
using the Greenhouse Gas Protocol guidelines. Our FY23
CO2-e total was 4.24 tonnes, principally from our scope 2
purchased electricity usage. This is a comparatively small
total, and when possible, we will endeavor to reduce our
footprint by purchasing renewable electricity. In the future,
we hope to calculate our scope 3 indirect emissions
(upstream and downstream) to further understand and
reduce our emissions profile. We currently purchase
offsets through our carrier when flights are essential
for business travel.
16
Opthea Limited
Opthea prioritizes waste reduction through partnerships
with sustainable vendors for our medical products, promoting
the decoupling of medical products from plastic waste. In our
Melbourne office, we adopt a collective approach to managing
office waste. As we prepare for our products that may enter
the market, we are developing a waste stream procedure
to address key waste sources, namely plastic needles, glass
vials, and associated packaging.
IP protection
The development of an innovative therapy to improve
patient vision underpins Opthea’s value. Considering this,
we understand that IP protection is a key issue. To protect
our intellectual property, Opthea engages professional
patent attorneys to provide oversight of our patent
portfolio and implement actions to protect it. Additionally,
Opthea recognizes the importance of fair and ethical
competitive practices in fostering a healthy business
environment. To uphold these principles, the company
maintains robust corporate governance measures in place
to address competitive behavior.
Opthea fosters a culture of innovation within the company by
encouraging creativity, promoting collaboration, and providing
resources to support experimentation. Through these efforts,
Opthea inspires and contributes to the development of our
novel therapies and to the future of biomedicine.
Diversity and inclusion
Through diversity, Opthea can tap into a wide range of
perspectives, experiences, and talents, leading to more
creative problem-solving and better outcomes. Inclusion
promotes an environment where every individual is valued
and respected, fostering an environment where everyone
can contribute their best.
During the three years ended June 30, 2023, 38% of
the directors and 55% of employees were female. As of
June 30, 2023, we had 24 full-time employees, eight of
whom had an MD or Ph.D. degree. None of our employees
are represented by collective bargaining agreements.
We believe that our management maintains good relations
with our employees. As of June 30, 2023, our employees
were based in Australia (8) and the United States (16),
with 17 employees in our research and development and
commercialization department and seven employees in our
general and administrative department.
Opthea’s ambition is to create a diverse and inclusive
workforce that reflects the global communities it serves.
We believe that everyone at Opthea has a voice, and that
this fosters an open, respectful, and collaborative culture.
Our ambition is to contribute substantially to
improving vision throughout society, and we work
toward this every day through our research and
development efforts.
17
Annual Report 2022 – 2023
Pillar 3: Ethics
Patient and data privacy
Opthea is working to safeguard patient information and
privacy by following General Data Protection Regulation
(“GDPR”) principles and guidelines and utilizing secure
systems that de-identify patient information. With an
increase in data breaches in various sectors over the
past year, having a procedure in place to protect the
data privacy of our patients is more important than ever.
We recognize the importance of patient privacy and adhere
to comprehensive guidelines for protecting and secure
handling of personal data. De-identifying patient information
by removal or encryption of personally identifiable data in
a secure system, is one of our ways to demonstrate that
we place data privacy at great importance.
At Opthea, we have also established a Data Monitoring
Committee (“DMC”) that follows data protection and
privacy rules, as well as data privacy training procedures
for all our staff. This demonstrates our commitment to
fostering a privacy-conscious workforce.
Animal ethics
Opthea is committed to conducting research and
development in a responsible and ethical manner.
We recognize the intrinsic importance and significance
of animal welfare and prioritize high ethical standards
throughout our supply chain. We minimize animal testing
by the “Three Rs” principle, being the reduction, refinement,
and replacement of animals in scientific research.
Opthea actively seeks alternative methods and technologies
to reduce reliance on animal experimentation and replaces
animals wherever possible.
We strictly adhere to internationally recognized guidelines
and regulations that aim to safeguard the welfare and
well-being of animals involved in our studies, placing
their care and humane treatment as a top priority.
Dealing with medical professionals
Opthea adheres to the highest standards of integrity,
transparency, and professionalism when dealing with
medical professionals. We work to ensure compliance
with applicable laws and regulations, avoid conflicts
of interest whether they be personal or financial, and
maintain independence and objectivity in the judgement
of medical opinions. This is done through transparent
relationships designed to prevent conflicts of interest,
through fair trading and dealing, and through our
anti-bribery policies. Details of these can be found
in our Code of Conduct statement.
Pillar 4: Accessibility, affordability, and fair pricing
Opthea believes that our mission to enhance public health
for better quality of life is one that should be shared with
the entire community. We are committed to making medical
products and treatments accessible to as many individuals
as possible. When bringing our products to market, we are
working to obtain coverage under the US benefits schedule,
meaning a co-payment price to improve the accessibility
of the drug to those who need it. Opthea is reaching out
to insurers to drive for this outcome, as well as to gauge
price expectations.
We expect our product to be priced at fair market value
for novel products. In the US and Japan in particular,
we expect that there will be a co-payment of which the
vast majority of patients have supplemental insurance
coverage. Many of the remaining developed nations have
social medical coverage and we expect that patients will
also have affordable access to this medicine. We plan to
engage the requisite marketing, medical affairs, and sales
personnel to promote the awareness of the affordability,
efficacy, and safety of our products among our health
care providers and patients.
Affordable medicines contribute to the long-term
sustainability of healthcare systems, and ultimately
benefit public health by reducing the burden on patients
and insurance providers. Our commitment to fairly
priced medical treatment is part of our dedication
to patient-centered care.
18
Opthea Limited
SDG 13
Climate action
13.3 Improve education, awareness-raising
and human and institutional capacity on
climate change mitigation, adaptation,
impact reduction and early warning.
As we expand our emissions profile to scope 3,
we intend to improve understanding of CO2
hotspots, and mitigate where possible.
SDG 10
Reduced inequalities
10.2 By 2030, empower and promote the
social, economic, and political inclusion of all,
irrespective of age, sex, disability, race, ethnicity,
origin, religion, or economic or other status.
Opthea promotes diversity and equality throughout
our hiring and employment policies. We also see
ourselves contributing towards a reduction in long
term healthcare inequality.
SDG 9
Industry, innovation and
infrastructure
9.5 Enhance scientific research, upgrade
technological capabilities of industrial sectors,
and encourage innovation.
Scientific research is at the heart of what
Opthea does, as is striving for medical innovation.
SDG 12
Responsible consumption
and production
12.5 By 2030, substantially reduce waste
generation through prevention, reduction,
recycling and reuse.
We work to minimise plastic consumption
wherever possible and will continue to do
so as our products come to market.
SDG 3
Good health and wellbeing
3.8 Achieve universal health coverage
Opthea is driving for access to quality
essential healthcare services, access
to safe and affordable medicines.
Our contribution to the Sustainable
Development Goals
The Sustainable Development Goals (SDGs) are
a set of 17 global objectives established by the
United Nations in 2015 to address socio-economic
and environmental challenges. They aim to provide
a common framework against which global efforts
can be directed. Opthea has identified the goals and
relevant sub-goals to which we expect our operations
and mission contribute.
While Opthea’s research is expected to contribute
most clearly to Good Health and Well-being (SDG 3),
it is important to consider the breadth of impact that
our organization can have across multiple goals.
Annual Report 2022 – 2023
19
Directors’
Report
The board of directors of Opthea
Limited submits its report for the
year ended June 30, 2023 for
Opthea and its subsidiaries.
Information about
the Directors
The names of Opthea Limited’s
(the Company or Opthea) Directors
in office during the financial year
and until the date of this report
are as follows:
Jeremy Levin, Non‑Executive
Director and Chairman
Megan Baldwin,
Managing Director and
Chief Executive Officer
Susan Orr,
Non‑Executive Director
Michael Sistenich, Non‑Executive
Director (resigned June 7, 2023)
Lawrence Gozlan,
Non‑Executive Director
Daniel Spiegelman,
Non‑Executive Director
Julia Haller,
Non‑Executive Director
Quinton Oswald,
Non‑Executive Director
Anshul Thakral, Non‑Executive
Director (appointed June 7, 2023)
The qualifications, experience
and special responsibilities of the
Company’s Directors are as follows:
Company Secretary
Karen Adams
BBus, CPA GAICD, FGIA FCG
Karen Adams, a fellow of the
Governance Institute of Company
Secretaries, was appointed as Vice
President Finance and Company
Secretary on June 15, 2021.
Jeremy Levin
PhD, MB BChir
Non‑Executive Director
and Chairman
Dr. Jeremy Levin has served as
the Chairperson of the board
of directors since October 2020.
Since 2015 Jeremy has served as
the Chief Executive Officer of Ovid
Therapeutics Inc., and since 2014, as
Chairperson of the board of directors,
of Ovid. From May 2012 to October
2013, Dr. Levin served as the President
and Chief Executive Officer of Teva
Pharmaceutical Industries Ltd.,
a publicly held pharmaceutical
company. From September 2007
to December 2012, Dr. Levin
held several roles at Bristol Myers
Squibb Company, a publicly held
pharmaceutical company, ultimately
serving as the Senior Vice President
of Strategy, Alliances and Transactions.
Dr. Levin also served as a member
of the executive committee at Bristol
Myers Squibb Company. Dr. Levin
earned a BA in Zoology, a MA in
Cell Biology and a PhD in Chromatin
Structure, all from University of
Oxford, and a MB BChir from the
University of Cambridge.
Megan Baldwin
BSc (Hons), PhD
Managing Director and
Chief Executive Officer
Dr. Megan Baldwin was appointed
CEO and Managing Director in
February 2014. Dr. Baldwin brings
over 20 years’ of experience focusing
on angiogenesis and therapeutic
strategies for cancer and ophthalmic
indications. Dr. Baldwin joined Opthea
in 2008 and since then has held
various positions, including Head of
Preclinical R&D and Chief Executive
Officer of Opthea Pty Ltd, formerly
a 100% owned subsidiary of Opthea,
developing sozinibercept for the
treatment of wet AMD. Prior to
joining Opthea, she was employed at
Genentech Inc. (now a member of the
Roche Group), a world leader in the
field of angiogenesis‑based therapies
for cancer and other diseases.
Her experience included several
years as a researcher in the group
of leading angiogenesis expert
Napoleone Ferrara, before moving to
Genentech’s commercial division and
having responsibility for corporate
competitive intelligence activities.
In these roles, she developed extensive
commercial and scientific knowledge
in the field of anti‑angiogenic
and oncology drug development.
She holds a PhD in Medicine from
the University of Melbourne, having
conducted her doctoral studies at the
Ludwig Institute for Cancer Research
on the biology of VEGF‑C and
VEGF‑D, is a member of the
Australian Institute of Company
Directors, a Director of Ausbiotech.
Michael Sistenich
MSc
Non‑Executive Director
Michael Sistenich was appointed
Non‑Executive Director of Opthea
in November 2015 and resigned June
7, 2023, and was Chairman of the
Remuneration Committee during his
term. Michael Sistenich has advised
a wide range of global institutions,
high-net-worth individuals and
companies on healthcare investments
over the past 20 years. He is a
healthcare specialist in international
investment management and
investment banking, and led the
Bell Potter team which advised the
Company through the $17.4 million
capital raising in November 2014.
Michael Sistenich is currently
Chairman of the board of Enlitic Inc,
and previously served as Director of
International Equities and Head of
Global Healthcare Investments at
DWS Investments, Deutsche Bank
Frankfurt. Michael has long-standing
capital market connections and
experience in the global healthcare
investment community.
Lawrence Gozlan
BSc (Hons)
Non‑Executive Director
Lawrence Gozlan was appointed
as a director on July 24, 2020 and
is Chairman of the Nominations
Committee. Mr. Gozlan, a biotechnology
investor and advisor, is the Life Sciences
Investment Manager at Jagen Pty Ltd,
an international private investment
organization. Mr. Gozlan is also the
Chief Investment Officer and Founder
of Scientia Capital, a specialized
global investment fund focused
exclusively on life sciences. Scientia
was founded to provide high level
expertise and to manage investments
for high‑net‑worth individuals, family
offices and institutional investors wanting
exposure to the life sciences industry.
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Opthea Limited
Prior to this, Mr. Gozlan was responsible
for the largest biotechnology investment
portfolio in Australia as the institutional
biotechnology analyst at QIC (“the
Queensland Investment Corporation”),
an investment fund with over $60 billion
under management. He previously
worked as the senior biotechnology
analyst in the equities team at Foster
Stockbroking, and gained senior
corporate finance experience advising
life science companies at Deloitte.
Mr. Gozlan holds a Bachelor of Science
with Honors in microbiology and
immunology from the University
of Melbourne.
Daniel Spiegelman
BA, MBA
Non‑Executive Director
Daniel Spiegelman has served as
a member of the board of directors
since September 2020 and is Chairman
of the Audit and Risk Committee.
From May 2012 to January 2020,
Mr. Spiegelman served as Executive
Vice President, Chief Financial
Officer of BioMarin Pharmaceutical
Inc., a biotechnology company. From
May 2009 to May 2012, Mr. Spiegelman
served as a consultant to provide
strategic financial management support
to a portfolio of public and private life
science companies. Mr. Spiegelman has
also served as a member of the board
of directors of Myriad Genetics,
a molecular diagnostic company
since May 2020, a Director of Jiya
Acquisitions Corp since November 2020
and a Director of Spruce Bioscience
since September 2020. Mr. Spiegelman
earned a BA from Stanford University
and an MBA from the Stanford
Graduate School of Business.
Dr. Julia Haller
MD, BA
Non‑Executive Director
Dr. Julia Haller was appointed
Non‑Executive Director of Opthea
in June 2021. Since 2007, Dr. Haller
has served as Ophthalmologist‑in‑Chief
and William Tasman. ME Endowed Chair
at Wills Eye Hospital in Philadelphia.
She is Professor and Chair of the
Department of Ophthalmology at the
Sidney Kimmel Medical College at
Thomas Jefferson University as well
as a Director of Bristol Myers Squibb
and Outlook Therapeutics. She is a
member of the National Academy of
Medicine, the Chair of the College of
Physicians of Philadelphia, Chair of the
Heed Ophthalmic Society, past president
of the Women in Medicine Legacy
Foundation, and serves on several
prestigious boards including the board
of the John Hopkins Medical and
Surgical Association, the Association of
University Professors of Ophthalmology,
and the Society of Heed Fellows.
Dr. Haller received a BA from Princeton
University, graduating magna cum
laude, and completed her medical
training at Harvard Medical School.
Dr. Susan Orr
OD
Non‑Executive Director
Susan Orr was appointed
Non‑Executive Director of Opthea in
April 2022. Dr. Orr is an experienced
medical and business leader with
specialization in identifying, developing
and commercializing ophthalmic
therapeutic product candidates.
Dr. Orr currently serves as the
Chief Medical Officer at Claris
Biotherapeutics and is a member of
the Retina Global Board of Directors.
Before Claris, Dr. Orr was the Chief
Executive Officer at Notal Vision
subsequent to joining the company
as Chief Medical Officer. Dr. Orr has
spent more that 30 years in the field
of ophthalmology that also includes
ten years in private optometric
practice and leadership roles at Alcon
and Janssen spanning international
development, global new product
strategy, and business development
and licensing. Dr. Orr participated
in multiple acquisitions including
Durezol® and Beovu® (brolucizumab)
and has been a Managing Partner at
Fovenedeye Consulting since 2016.
Quinton Oswald
Non‑Executive Director
Quinton Oswald was appointed
Non‑Executive Director of Opthea
in April 2022. Mr. Oswald brings over
25 years of international general
management experience, including
onsite assignments in the US, Europe
and South Africa. Most recently, he
was the CEO of Notal Vision, a
commercial‑stage ophthalmic home
monitoring services provider with
a focus on both wet and dry AMD.
Prior to Notal Vision, he served as the
CEO of Neurotech and, prior to that,
as the CEO of SARcode Bioscience,
where he was instrumental in the
clinical development of lifitegrast
ophthalmic solution 5% (Xiidra®) for
the treatment of dry eye disease,
and its subsequent sale to Shire, PLC.
Previously, he was Vice President and
Business Unit Head for Genentech’s
tissue growth and repair business.
During his tenure at Genentech,
Mr. Oswald oversaw the highly
successful commercial launch of
Lucentis® (ranibizumab) for the
treatment of wet AMD. Before
Genentech, Mr. Oswald led the
North American Ophthalmology
business for Novartis, which,
in conjunction with QLT, Inc.,
pioneered Visudyne®.
Anshul Thakral
BS, MSE, MBA
Non‑Executive Director
Mr. Thakral is Chief Executive Officer
and Board Member of Launch
Therapeutics, a clinical development
company backed by funds managed by
global investment firm Carlyle and its
life sciences franchise, Abingworth.
Mr. Thakral has worked for over 20 years
in the pharmaceutical and biotechnology
industry and is an experienced
executive, management consultant
and entrepreneur. Mr. Thakral was
previously Chief Commercial Officer
and Executive Vice President of Peri
and Post-Approval Services at PPD,
and prior to that was Global Head of
PPD Biotech. Before PPD, Mr. Thakral
ran the global life sciences business
unit at Gerson Lehrman Group and
worked at McKinsey & Company as
an associate principal in the health care
practice, where he provided strategic
advice to global pharmaceutical and
biotechnology companies on growth,
research and development, business
development and commercialization.
He currently serves on the boards of
TriNetX, Saama Technologies, Orsini
Specialty Pharmacy, is an Operating
Executive at Carlyle and is a Venture
Partner at Abingworth.
Mr. Thakral holds a Master’s degree
in Biomedical Engineering from Johns
Hopkins University and a Masters
Business Administration (MBA) from
the Wharton School at the University
of Pennsylvania. We believe Mr. Thakral’s
extensive experience in the global
biotechnology and pharmaceutical
industry qualifies him to serve on our
board of directors.
Annual Report 2022 – 2023
21
Directors’ Report (cont.)
Directorships of other listed companies
Directorships of other listed companies held by directors in the three years immediately before the end of the financial year
are as follows:
Director
Company
Period of directorship
Jeremy Levin
Ovid Therapeutics Inc (NASDAQ)
Since 1997
Megan Baldwin
Invex Therapeutics (ASX)
Since 2020
Lawrence Gozlan
Alterity Therapeutics Limited (ASX)
Since 2011
Daniel Spiegelman
Myriad Genetics (NASDAQ)
Spruce BioScience (NASDAQ)
Since 2020
Since 2020
Julia Haller
Bristol Myers Squibb (NYSE)
Outlook Therapeutics (NASDAQ)
Since 2019
Since 2022
Directors’ interests
At the date of this report, the relevant interests of each director of the Company in the contributed equity of the Company
are as follows:
Fully paid
ordinary
shares
Options/
Rights granted
under LTIP and
NED Plans
Megan Baldwin
3,839,398
4,600,000
Jeremy Levin
–
3,000,000
Michael Sistenich (resigned June 7, 2023)
1,233,097
1,500,000
Lawrence Gozlan
1,877,357
2,000,000
Daniel Spiegelman
–
2,000,000
Julia Haller
–
2,000,000
Susan Orr
–
1,000,000
Quinton Oswald
–
1,000,000
Anshul Thakral (appointed June 7, 2023)
–
–
22
Opthea Limited
Directors’ Report (cont.)
Share options
As of June 30, 2023 and the date of this report, details of Opthea’s interests under option are as follows:
Long-Term Incentive and Non‑Executive Director Share and Option Plans
During the 2018, 2019, 2021, 2022 and 2023 financial years the Company granted 26,955,000 options, rights and
ADS options remain available to purchase ordinary shares to directors and employees under the Long‑Term Incentive (LTIP)
and Non‑Executive Director Share and Option (NED) Plans.
Grant date
Expiry date
Granted to
Exercise price
Number
of options
granted
August 23, 2017
January 1, 2023
Employees under the LTIP
$0.92
500,000
November 29, 2018
November 29, 2022
Directors under the LTIP and NED plan
$0.625
6,000,000
April 3, 2019
April 3, 2023
Employees under the LTIP
$0.608
2,844,000
October 12, 2020
October 11, 2024
Directors under the NED Plan
$2.16
2,000,000
October 12, 2020
October 11, 2024
Directors under the NED Plan
$3.24
2,000,000
January 19, 2021
January 18, 2025
Directors under the NED Plan
$1.56
3,000,000
October 19, 2021
October 18, 2025
Directors under the NED Plan
$0.948
2,000,000
October 19, 2021
October 18, 2025
Employees under the LTIP
$0.948
2,000,000
April 21, 2022
April 21, 2026
Directors under the NED Plan
$0.75
2,000,000
June 6, 2022
June 6, 2032
Employees under the LTIP
$1.46
800,000
April 21, 2022
April 21, 2026
Directors under the NED Plan
$0.75
2,000,000
November 16, 2022
November 16, 2032
Directors under the NED Plan
$0.658
3,500,000
November 16, 2022
November 16, 2032
Directors under the NED Plan
$0.672
2,000,000
November 16, 2022
November 16, 2032
Directors under the LTIP
$0.658
3,000,000
December 13, 2022
December 13, 2032
Employees under the LTIP
$0.644
250,000
31,894,000
Grant date
Expiry date
Granted to
Exercise price
Number of
performance
rights
October 19, 2021
October 19, 2031
Director under the LTIP
$ Nil
1,600,000
November 16, 2022
November 16, 2032
Director under the LTIP
$ Nil
650,000
November 16, 2022
November 16, 2032
Director under the NED
$ Nil
650,000
2,900,000
Annual Report 2022 – 2023
23
Directors’ Report (cont.)
Grant date
Expiry date
Granted to
Exercise price
Number of
ADS options
January 10, 2022
January 10, 2032
Employees under the LTIP
$7.51
150,000
March 1, 2022
March 1, 2032
Employees under the LTIP
$6.01
300,000
April 18, 2022
April 18, 2032
Employees under the LTIP
$6.09
80,000
May 23, 2022
May 23, 2032
Employees under the LTIP
$7.12
80,000
June 1, 2022
June 1, 2032
Employees under the LTIP
$7.45
80,000
June 20, 2022
June 20, 2032
Employees under the LTIP
$5.52
60,000
July 1, 2022
July 1, 2032
Employees under the LTIP
$6.35
175,000
October 24, 2022
October 24, 2032
Employees under the LTIP
$4.85
300,000
October 28, 2022
October 28, 2032
Employees under the LTIP
$5.17
20,000
January 16, 2023
January 16, 2033
Employees under the LTIP
$4.93
50,000
February 1, 2023
February 1, 2033
Employees under the LTIP
$5.24
75,000
February 13, 2023
February 13, 2033
Employees under the LTIP
$5.15
25,000
April 18, 2023
April 18, 2033
Employees under the LTIP
$3.54
110,000
1,505,000
The Remuneration Report section of this report contains details on the terms and conditions of the options granted under the
Company’s LTIP and NED Plans.
Dividends
No cash dividends have been paid, declared or recommended during or since the end of the financial year by the Company.
Principal activities
The principal activity of Opthea Limited is to develop and commercialize therapies primarily for eye disease. Opthea’s lead asset,
sozinibercept (OPT-302), is a soluble form of vascular endothelial growth factor receptor-3 “VEGFR-3” in clinical development
as a novel therapy for wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Wet AMD and DME are
leading causes of blindness in the elderly and diabetic populations respectively and are increasing in prevalence worldwide.
Opthea’s principal activities in 2022-2023 included progression of the Company’s Phase 3 registrational trials of sozinibercept
(OPT-302) for wet AMD through the activation of clinical trial sites in countries globally and continued enrollment of patients
into the studies. Opthea also manufactured sozinibercept for use in the Phase 3 clinical trials, conducted activities to support
commercialization of the product and expanded its management team in the US to facilitate broader oversight and execution
of its Phase 3 program.
Opthea’s development activities are based on an extensive intellectual property portfolio covering key targets (Vascular
Endothelial Growth Factors VEGF‑C, VEGF‑D and VEGF Receptor‑3) for the treatment of diseases associated with blood
and lymphatic vessel growth (angiogenesis and lymphangiogenesis respectively), as well as vascular leakage. Angiogenesis and
vascular leakage are key hallmarks of several eye diseases, including wet AMD and DME.
24
Opthea Limited
Directors’ Report (cont.)
Operating and financial review
Financial performance
The consolidated results of Opthea and its subsidiaries (the Group) for the year reflect the Group’s investment in advancing
sozinibercept for wet AMD.
A summary of the results is as follows:
•
The major expenditure of the Group has been in relation to Research & Development (“R&D”), in particular costs associated
with the Phase 3 clinical trials;
•
Total R&D expenditure amounted to US$122,128,314 (2022: US$78,654,217). Including personnel costs and other R&D
support costs which are included in administrative costs, total expenditure in R&D tax claim amounted to US$13,623,793
(2022: US$14,481,116);
•
Opthea received an R&D tax incentive payment during the year of US$6,299,286 (2022: US$4,972,898); and
•
The consolidated net loss of the Group for the year was US$128,426,262 after an income tax benefit of US$5,926,350
(2022: loss of US$92,817,371 after an income tax benefit of US$6,299,286).
Financial position
The Group’s statement of financial position includes the following key balances:
•
Consolidated cash balances as of June 30, 2023 amounted to US$89,188,713 (2022: US$44,631,293);
•
Receivables of US$6,562,915 (2022: US$6,556,954) include the Opthea Group’s expected refund of R&D tax incentives
for the year to June 2023 of US$5,926,350 (2022: US$6,299,286);
•
The Group has a net current asset surplus of US$79,643,659 (2021: US$47,866,741); and
•
The net tangible asset backing per share as at June 30, 2023 was (US$0.01) (2022: US$0.14); Opthea’s share price was
A$0.52 (2022: A$1.10).
Opthea: Company overview
Opthea is committed to the development of new therapies for the treatment of serious eye diseases that affect the back
of the eye, or retina, and lead to vision loss.
Opthea’s lead candidate Sozinibercept (OPT-302) is a first in class VEGF-C/D inhibitor being developed as a complementary
treatment to be used in conjunction with VEGF-A inhibitors for the treatment of wet AMD and other retinal diseases.
Sozinibercept has the potential to be combined and positioned as complementary with any anti-VEGF-A therapy for the
treatment of wet AMD, a strategy intended to maximize the commercial opportunity for the therapy.
Wet AMD is a progressive, chronic disease of the retina and in developed nations, is the leading cause of visual impairment in
people over the age of 50 years. Wet AMD is associated with blood vessel dysfunction and proliferation in the macula, a region
of the retina which is needed for sharp, central vision. New blood vessels break through layers of the retinal tissue, leaking fluid,
lipids and blood, leading to fibrous scarring and loss of vision. Vision loss associated with wet AMD can be rapid and is generally
severe, impacting patient independence and contributing to significant healthcare and economic costs worldwide.
Although the underlying cause and biology of wet AMD is complex, inhibition of vascular endothelial growth factor A, or
VEGF-A, has been shown to play an important role in the growth and leakage of vessels associated with the disease, and
inhibitors of VEGF-A are now standard of care treatments for wet AMD. The VEGF-A inhibitors ranibizumab (Lucentis®) and
aflibercept (Eylea®), approved for the treatment of wet AMD and other retinal indications, together generated worldwide
revenues in excess of US$12 billion in 2022. Such commercial success reflects the widespread use of the VEGF-A inhibitor
class of therapies and the importance that physicians and patients alike attribute to the preservation and improvement of
visual acuity for quality of life.
Annual Report 2022 – 2023
25
Directors’ Report (cont.)
However, despite many patients experiencing gains or stabilization of vision, at least 45% of patients with wet AMD exhibit a
sub optimal response to therapies that selectively target VEGF-A. As such, there remains a very large commercial opportunity
for novel therapies that address the unmet medical need for patients who have further room for improvement in visual acuity
despite regular administration of currently available treatments.
Opthea’s lead product candidate sozinibercept is differentiated with a key objective to improve clinical efficacy and the potential
to also produce more sustained, durable clinical outcomes for patients. The majority of agents currently in clinical development
are seeking to reduce the frequency of patient treatments, rather than provide superior vision gains for those affected by retinal
diseases. With a scarcity of combination therapies in development that may offer improved outcomes for retinal disease patients,
and with positive Phase 2b data in wet AMD, we believe sozinibercept is a promising drug candidate with large commercial
potential as it advances through the final stage of clinical development, Phase 3 pivotal studies.
Sozinibercept: Opthea’s Phase 3 asset for the treatment of wet AMD
Wet AMD is associated with vascular dysfunction and fluid accumulation at the back of the eye in a region of the central
retina or macula that is needed for sharp, central vision. Vessel growth and vascular leakage are primarily driven by members
of the vascular endothelial growth factor (“VEGF”) family, which comprises 5 members including VEGF-A, VEGF-B, VEGF-C,
VEGF-D and placenta growth factor (“PlGF”). Elevated levels of these factors are associated with retinal disease progression.
Current treatments, as well as many agents currently in clinical development for wet AMD and DME, share a common
mechanism of action by inhibiting VEGF-A. Sozinibercept has a differentiated mechanism of action by binding and blocking
the activity of VEGF-C and VEGF-D, which are also important stimulators of blood vessel growth and vascular leakage
and implicated in the progression of retinal diseases. Sozinibercept is a soluble fusion protein consisting of the first three
extracellular domains of VEGFR-3 fused to the Fc fragment of human immunoglobulin G1 (IgG1). Sozinibercept binds or
“traps” VEGF-C and VEGF-D with high affinity, blocking the activity of both proteins.
Sozinibercept is administered by intravitreal injection into the eye, which is the same route of administration of approved,
standard of care treatments for wet AMD. By combining administration of sozinibercept, with a VEGF-A inhibitor through
sequential intravitreal injections, broader blockade of important signaling pathways that contribute to the pathophysiology
of retinal diseases can be achieved, which may improve visual acuity and retinal swelling in patients. In addition, inhibition of
VEGF-A results in compensatory upregulation of VEGF-C and VEGF-D that may limit the efficacy of selective VEGF-A inhibitors.
Sozinibercept blocks this mechanism of resistance to existing therapies which may then result in improved and more durable
clinical responses.
Operational update
Over the past 12 months, Opthea continued to advance its clinical development program investigating sozinibercept as a
combination therapy for wet AMD. The majority of the Company’s activities were focused on progressing its Phase 3 pivotal
program in wet AMD, through continued patient recruitment into the ShORe and COAST clinical trials which are, as of August
2023, approximately 75% enrolled. Throughout the year, Opthea continued to activate clinical trial globally and to manufacture
sozinibercept (OPT-302) to current good manufacturing practices, or cGMP standards for use in the clinical trials and for
pre-commercial purposes. The Company also conducted activities to support commercialization of the product, included
enhancing its presence at clinical ophthalmology conferences and symposia. The Company also participated in several
investment events focused on emerging ophthalmology companies. These increased efforts were further facilitated by the
growth of Opthea’s management team in the US to execute its Phase 3 program and begin pre-commercialization activities.
Sozinibercept was advanced into Phase 3 pivotal trials based on clinical experience to date, which includes three completed
clinical trials. At the annual American Society of Retinal Specialists meeting in August 2023 a pooled safety analysis of 399
patients from completed sozinibercept trials was presented. The presentation concluded that the safety data from our completed
sozinibercept trials show sozinibercept combination therapy has a safety and tolerability profile comparable to standard of care
anti-VEGF-A monotherapy.
26
Opthea Limited
Directors’ Report (cont.)
Notably from our previously completed clinical trials, the statistically significant positive outcomes from the Company’s 366
patient, randomized, sham controlled Phase 2b clinical trial in treatment naïve wet AMD patients informed the design of the
Phase 3 program.
In July 2023, Opthea announced “sozinibercept” as the non-proprietary drug name for OPT-302. The American Medical
Association’s United States Adopted Names (USAN) Council, in consultation with the World Health Organization’s International
Non-proprietary Names (INN) Expert Committee, approved and adopted the non-proprietary drug name. Opthea will use the
name sozinibercept (formerly OPT-302) in upcoming publications, public statements, and in corporate materials moving forward.
Opthea’s Phase 3 pivotal trials – ShORe and COAST
Opthea’s Phase 3 program consists of two concurrent, global, multi centre, randomized, sham controlled studies:
•
ShORe: Study of Sozinibercept (OPT‑302) in combination with Ranibizumab (Study Sozinibercept (OPT‑302) 1004); and
•
COAST: Combination Sozinibercept (OPT‑302) with Aflibercept Study (Study Sozinibercept (OPT‑302) 1005).
Both ShORe and COAST are currently enrolling treatment naïve patients.
In ShORe, treatment naïve patients with wet AMD are randomized to one of three treatment arms to receive standard of care
0.5 mg ranibizumab every four weeks in combination with either 2.0 mg sozinibercept on a standard every four weeks dosing
regimen or 2.0 mg sozinibercept on an extended every eight weeks dosing regimen after three monthly initiating doses, or with
sham injections every four weeks.
In COAST, treatment naïve patients with wet AMD are randomized to one of three treatment arms to receive standard of
care 2.0 mg aflibercept on its every eight week dosing regimen, after three monthly initiating doses, in combination with either
2.0 mg sozinibercept on a standard every four weeks dosing regimen or 2.0 mg sozinibercept (OPT-302) on an extended every
eight weeks dosing regimen after three monthly initiating doses, or with sham injections every four weeks.
Each of the ongoing trials is expected to enroll approximately 990 patients worldwide. The primary endpoint for both trials is
mean change in visual acuity from baseline to week 52 for sozinibercept and anti-VEGF-A combination therapy compared to
anti-VEGF-A monotherapy, with the Company intending to submit Biologics License and Marketing Authorization Applications
with the FDA and EMA respectively following completion of this primary efficacy phase of the trials. Each patient will continue
to be treated for a further year to evaluate safety and tolerability over a two-year period.
These two sozinibercept Phase 3 trials build upon and maintain key features for consistency with the Company’s positive
Phase 2b clinical trial of sozinibercept (OPT‑302), while evaluating the administration of sozinibercept combination therapy over
a longer treatment period and in a greater number of patients.
In addition, the Phase 3 trials are optimized based on Phase 2b outcomes to maximize probability of success and commercial
opportunity. Analysis of the Phase 2b trial demonstrated that sozinibercept (OPT-302) combination therapy increased visual
acuity by a further +5.7 letters over ranibizumab monotherapy in wet AMD patients with minimally classic and occult lesions,
representing the majority (~80%) of wet AMD patients. Based on this positive data, primary analysis of the primary endpoint
of the Phase 3 trials will be first conducted in patients with minimally classic and occult lesions administered sozinibercept
(OPT-302) every 4 weeks and every 8 weeks, followed by analysis in the predominantly classic lesions and total
patient population.
Opthea expects to complete patient recruitment in the Phase 3 clinical trials of sozinibercept for the treatment of wet AMD
in the COAST and ShORe studies in the first and second quarter of calendar year 2024 respectively. The primary outcome
of the trials is expected to be reported as topline data when all patients complete the 52-week treatment period for the primary
analysis. If the topline results at the completion of the primary efficacy phase are favorable, Opthea expects to file for marketing
approval for sozinibercept for the treatment of wet AMD in the United States, European Union and other territories.
Annual Report 2022 – 2023
27
Directors’ Report (cont.)
Corporate update
In August 2022, Opthea was pleased to announce a non-dilutive financing transaction for up to US$170 million from Carlyle and
its life sciences franchise Abingworth, working with their recently formed development company Launch Therapeutics (“Launch Tx”).
The non-dilutive financing consists of a US$120 million commitment and an option to increase funding by a further US$50 million.
The Company has recently been notified that a co-investor of Carlyle and Abingworth intends to increase funding by US$50 million,
which is subject to the co-investor’s final due diligence and receipt of regulatory and tax approvals, appropriate documentation
and compliance with closing conditions. There can be no assurance that the due diligence will be completed to the satisfaction
of the co-investor of Carlyle and Abingworth, that the closing terms and conditions will be satisfied or that we will ultimately receive
the additional US$50 million. If sozinibercept is approved in a major market, Carlyle and Abingworth will be eligible to receive
seven fixed success payments over six years, and variable success payments of 7% on annual net sales, which terminate after
reaching four times the funded amount.
Concurrent with this non-dilutive financing, Opthea also announced the close of a US$90 million equity financing which was
well supported by existing and new institutional investors, including large global and US-based funds. The private placements
consisted of two tranches. The first tranche for A$60.7 million (US$41.9 million) was funded on August 24, 2022. Opthea closed
the second tranche, for US$47.5 million, or 59 million shares in September 2022.
In August 2023 Opthea also announced a non-underwritten institutional placement (“Placement”) and accelerated
non-renounceable entitlement offering of A$90 million (approximately US$58 million).
These financing arrangements strengthen Opthea’s strategic position to maximize the value of Sozinibercept and will be used
to continue advancing the clinical development of sozinibercept for the treatment of wet AMD, including to progress the Phase 3
clinical program and for general corporate purposes. Opthea’s successful capital raisings further validate our commitment to
bring sozinibercept (OPT-302) to wet AMD patients, a disease for which there remains significant unmet medical need despite
the availability of therapies that selectively target VEGF-A.
Opthea believes that its existing cash and cash equivalents as of June 30, 2023, as well as net proceeds from the 2023 Equity
Offering, – and the incremental US$50 million under the funding agreement as described above is received, and the remaining
$35 million under the Funding Agreement which is expected to be received by December 31, 2023, if received, will enable us to
fund our operating and research and development expenses into the third calendar quarter of 2024. If patient enrollment continues
to be delayed in the future, or if any additional factors cause the Phase 3 clinical trials to be further delayed or more costly, then
Opthea will need to obtain additional financing earlier than the third quarter of calendar year 2024. However, Opthea will need
to raise additional funds to complete the efficacy and safety phase of both studies and to report top-line data.
The amounts and timing of Opthea’s expenditures will depend upon and have been impacted in the past, and may continue
to be impacted by, numerous factors, including the results of its research and development efforts, the timing and success of
ongoing clinical trials or clinical trials that Opthea may commence in the future, the rate of patient recruitment into the trials,
the timing of regulatory submissions, the performance and cost efficiency of third parties that assist Opthea with clinical
development, including clinical research organizations (“CROs”), and macroeconomic challenges. Opthea has in the past incurred
significantly increased costs in connection with the activities conducted by third party CROS and other service providers to prepare
for and progress our Phase 3 clinical trials, and may continue to incur higher than expected costs for such activities in the future.
Opthea has based its beliefs and expectations stated above on assumptions that may prove to be wrong. Opthea may also
experience future delays in its clinical development or commercialization of sozinibercept for any indication, including due to
the factors and conditions set forth above or other factors that Opthea cannot presently anticipate, and may use its available
capital resources sooner than Opthea currently expects. Opthea will require additional funding to complete its Phase 3 clinical
trials in wet AMD. In addition, Opthea may require additional external funding to meet the minimum cash condition under the
non-dilutive financing agreement, including prior to the expected readout of top-line results for Opthea’s Phase 3 clinical trials.
See the “Risk Factors” section included at the end of this report.
Significant changes in the state of affairs
In the opinion of the directors, there were no significant changes in the state of affairs of the Company that occurred during
the financial year under review.
28
Opthea Limited
Directors’ Report (cont.)
Future developments
Opthea’s key objective over the next 12 months is to complete enrollment in the ShORe and COAST Phase 3 clinical trials by
continuing patient recruitment into the trials globally and to prepare for topline data readout from the trials, expected when
all patients complete the 52-week treatment period.
To achieve this objective, Opthea will continue to engage with clinical trial sites, investigators and the clinical ophthalmology
community and focus on robust trial execution.
Over the following 12 months, we will also continue to raise the awareness of the commercial potential inherent in sozinibercept
(OPT-302) for the treatment of serious retinal diseases. Opthea will also continue to maintain its presence at international
investment and clinical ophthalmology conferences and symposia, progress cGMP manufacturing activities of sozinibercept
(OPT-302) to support future commercial efforts and continue pre-commercial activities to position sozinibercept (OPT-302)
as a promising therapeutic for the treatment of wet AMD.
Significant events after balance date
On August 24, 2023, Opthea announced a A$80 million capital raise consisting via a A$10 million private placement (“Placement”)
and a A$70 million Accelerated Non-Renounceable Entitlement Offer (“ANREO”). On August 28, 2023, Opthea announced an
increase in the private placement by a further A$10 million to increase the overall raise to A$90 million. The proceeds from the
Placement and Entitlement will be used to continue advancing the clinical development of OPT-302 for the treatment of wet
Age-related Macular Degeneration (wet AMD) including to progress the Company’s Phase 3 clinical trials and for general
corporate purposes.
The Equity Financing of A$90 million (approximately US$58 million) consists of two closings, of which the first closing of A$73 million
(US$47 million) consisting of a placement offering and an acceleration portion of an Accelerated Non-Renounceable Entitlement
Offer (“ANREO”) occurred on September 1, 2023. The second closing of A$17 million (US$11 million), representing the remaining
institutional and retail portion of the ANREO, occurred on September 20, 2023. The shares were issued and cash received on
September 20, 2023.
Subsequent to June 30, 2023, the Group was notified that a new co-investor of Carlyle and Abingworth intends to participate in
a funding under the DFA of US$50 million to increase total DFA funding from US$120 million to US$170 million, which is subject
to the co-investor’s final due diligence and receipt of regulatory and tax approvals, appropriate documentation and compliance with
closing conditions. Upon completion of the final due diligence, receipt of regulatory and tax approvals, execution of the appropriate
documentation and satisfaction of the closing conditions, the Group expects to receive the additional US$50 million. While the
Group anticipates that the due diligence will be completed to the satisfaction of the co-investor, the necessary approvals will be
obtained, the appropriate documentation will be executed and that all closing conditions will be satisfied, there is no assurance that
the Group will ultimately receive the additional US$50 million. If the additional US$50 million is not received by June 30, 2024,
the Group will need to raise additional funds or reduce expenditures to continue as a going concern.
On August 28, 2023 Mr Lawrence Gozlan, a director of the Company, and the Company have entered into a Consultancy
Agreement of up to US$300,000 in respect of the provision of services associated with managing, overseeing and coordinating the
conduct and implementation of the Capital Raising. The consultancy agreement is effective for the financial year June 30, 2024.
In the opinion of the Directors, these duties are outside the scope of the ordinary duties of a Director.
Besides the above, there are no other significant events after June 30, 2023, to report.
Environmental regulations
The Company is not subject to significant environmental regulations.
Indemnification and insurance
During the financial year ended June 30, 2023, the Company indemnified its directors, the company secretary and executive
officers in respect of any acts or omissions giving rise to a liability to another person (other than the Company or a related party)
unless the liability arose out of conduct involving a lack of good faith. In addition, the Company indemnified the directors, the
company secretary and executive officers against any liability incurred by them in their capacity as directors, company secretary
or executive officers in successfully defending civil or criminal proceedings in relation to the Company. No monetary restriction
was placed on this indemnity.
Annual Report 2022 – 2023
29
Directors’ Report (cont.)
The Company has insured its directors, the company secretary and executive officers for the financial year ended June 30, 2023.
Under the Company’s Directors’ and Officers’ Liabilities Insurance Policy, the Company shall not release to any third party or
otherwise publish details of the nature of the liabilities insured by the policy or the amount of the premium. Accordingly, the
Company relies on section 300(9) of the Corporations Act 2001 to exempt it from the requirement to disclose the nature of
the liability insured against and the premium amount of the relevant policy.
Directors’ meetings
The number of meetings of directors and meetings of committees of the board held during the year are set out below.
Attendance by the directors at these meetings as relevant to each of them is as shown. It is the Company’s practice to invite
all directors to committee meetings irrespective of whether they are members.
Meetings of committees
Directors’
meetings
Audit & risk
Nomination
Clinical
Remuneration
Number of meetings held
5
6
2
2
4
Number of meetings attended:
Jeremy Levin
5
6
3
Michael Sistenich (resigned June 7, 2023)
5
6
2
4
Lawrence Gozlan
5
6
2
4
Daniel Spiegelman
5
6
2
Julia Haller
5
2
4
Anshul Thakral (appointed June 7, 2023)
5
6
1
2
3
Susan Orr
5
2
Quinton Oswald
5
2
Megan Baldwin
5
6
1
2
4
Committee membership
During the year, the Company had Audit and Risk, Remuneration and Nomination committees. Members acting on the
committees of the board during the year were:
Audit & Risk
Nomination
Clinical
Remuneration
Daniel Spiegelman (Chairman)
Lawrence Gozlan
(Chairman)
Susan Orr
(Chair)
Michael Sistenich (Chairman)
(resigned June 7, 2023)
Michael Sistenich
(resigned June 7, 2023)
Michael Sistenich
(resigned June 7, 2023)
Quinton Oswald
Lawrence Gozlan
Lawrence Gozlan
Daniel Spiegelman
Julia Haller
Julia Haller
Quinton Oswald
(July, 1, 2023)
Quinton Oswald
(June 7, 2023)
Megan Baldwin
Quinton Oswald (Chairman)
(June 7, 2023)
Susan Orr
(July 1, 2023)
Auditor’s independence declaration
The directors have obtained a declaration of independence from Deloitte Touche Tohmatsu, the Company’s auditors,
which is set out on page 92 and forms part of the directors’ report for the financial year ended June 30, 2023.
30
Opthea Limited
Directors’ Report (cont.)
Proceedings on behalf of the Company
There were no persons applying for leave under section 237 of the Corporations Act 2001 to bring, or intervene in, proceedings
on behalf of the Company.
Remuneration report – audited
This remuneration report, which forms part of the directors’ report, sets out information about the remuneration of Opthea
Limited’s Key Management Personnel for the financial year ended June 30, 2023. Following are the major topics covered in
this report:
1. Key Management Personnel
2. Remuneration Philosophy
3. Remuneration Committee
4. Diversity
5. Categorization of Key Personnel
6. Remuneration Framework
7. Service Contracts
8. Valuation of Shares
9. Additional Information
Key management personnel
The remuneration report details the remuneration arrangements for Key Management Personnel (“KMP”) who are defined
as those people having authority and responsibility for planning, directing, and controlling the major activities of the group,
directly or indirectly. The table below outlines the KMP of the group during the financial year ended June 30, 2023.
The individuals were KMP for the entire financial year, except were indicated in the table below:
Non‑executive directors
Jeremy Levin
Chairman, Non‑executive director
Julia Haller
Non‑executive director
Daniel Spiegelman
Non‑executive director
Michael Sistenich (resigned June 7, 2023)
Non‑executive director
Lawrence Gozlan
Non‑executive director
Susan Orr
Non‑executive director
Quinton Oswald
Non‑executive director
Anshul Thakral (appointed June 7, 2023)
Non‑executive director
Executive officers
Megan Baldwin
Chief Executive Officer and Managing Director
Karen Adams
Vice President Finance and Company Secretary
Timothy Morris (appointed October 24, 2022)
Chief Financial Officer
Judith Robertson
Chief Commercial Officer
Joel Naor (resigned July 15, 2023)
Chief Medical Officer
Except as noted, the named persons held their current position for the whole of the financial year and since the end of the
financial year.
Annual Report 2022 – 2023
31
Directors’ Report (cont.)
Remuneration philosophy
The broad remuneration philosophy is to ensure the remuneration package is consistent with current industry best practices &
market trends, properly reflects the person’s duties and responsibilities and aligns reward with the delivery of performance that
is likely to create value for shareholders. In framing its remuneration strategy, the Board is conscious that Opthea only has a small
number of employees (~25) so endeavors to keep its remuneration relatively straightforward. Hence, remuneration packages
comprise of fixed remuneration, Short‑Term Incentives (STI) in cash, and equity based Long‑Term Incentives (LTI). Opthea’s staff
are required to have specialist knowledge and experience allowing them to develop products over the medium to long-term.
Salary and remuneration benchmarking is undertaken by Opthea each year for executive and non‑executive positions.
Opthea benchmarks fixed and total remuneration against employment positions of comparable specialization, size and
responsibility within the industry. Fixed remuneration is supplemented by providing incentives (variable remuneration) to
reward superior performance.
Information is obtained from independent surveys to ensure that remuneration is set at market rates having regard to experience
and performance and the need to have effective retention strategies for key executives and scientific staff. Formal performance
appraisals are also conducted at least annually for all employees.
Opthea’s remuneration structure aims to:
•
Attract and retain exceptional people to lead and manage the group and to support internal development of executive
talent within the group, recognizing that Opthea is operating in a competitive global pharmaceutical industry environment;
•
Drive sustainable growth and returns to shareholders, as executives are set both short‑term and long‑term performance
targets which are linked to the core activities necessary to build competitive advantages and shareholder value;
•
Motivate and reward superior performance by the executive team whilst aligning performance elements/KPIs to the
interests of shareholders; and
•
Create a respectful culture based on superior performance and innovation through appropriately structured
individual assessments.
Remuneration Committee
A Remuneration Committee is established to review and make recommendations to the Board on remuneration packages
and policies applicable to directors and employees of the Company. In some cases, the Board may exercise discretion to take
account of events and circumstances not envisaged.
The philosophy of the Remuneration Committee is to focus on driving performance over and above shareholder and market
expectations and, in doing so, to directly reward those individuals who contribute to that performance.
The Committee consists of a minimum of three members, the majority being independent directors; and an
independent chairman.
The broad objectives of the Remuneration Committee are:
•
to link remuneration to the creation of shareholder value;
•
to offer competitive and appropriate remuneration for the business performance delivered; and
•
to put into place a remuneration framework that reflects the responsibilities of the executives while being sufficiently
competitive to attract and retain high calibre performers.
The Role and Responsibilities of the Remuneration Committee are:
•
Oversee the remuneration strategy of the Company and recommend or make such changes to the strategy as the
Committee may deem to be appropriate.
•
Ensure remuneration policies and practices enable the Company to attract, motivate and retain a diverse mix of directors
and executives who will create value for shareholders.
32
Opthea Limited
Directors’ Report (cont.)
•
Fairly and responsibly remunerate directors and executives having regard to their performance, the performance
of the Company and the general pay environment.
•
Require that the Board determine remuneration of non‑executive directors. The Committee may request management
or external consultants to provide necessary information upon which the Board may make its determination.
•
Ensure remuneration disclosure compliance in the Company’s Annual Report.
•
At least annually, review and report on the relative proportion of women and men in the workforce at all levels of the
Company as per Principle 3 of the ASX Corporate Governance Principles and Recommendations.
•
The Committee shall have the right to seek any information it considers necessary to fulfill its duties, which includes
the right to obtain appropriate external advice at the Company’s expense.
Diversity
The directors consider annually if the diversity of the Company’s personnel is appropriate. During the three years ended
June 30, 2023, 33% of the directors, 58% of employees and 77% of senior executives were female.
Categorization of KMP
The Key Management Personnel are categorized into two categories:
•
Executive Directors – Involvement in the day‑to‑day management of the Company or being in the full‑time salaried
employment of the Company defines the director as Executive. An Executive Director, through his or her privileged position,
has an intimate knowledge of the workings of the Company. There can, therefore, be an imbalance in the amount and quality
of information regarding the Company’s affairs possessed by executive and non‑executive directors. Executive Directors
carry an added responsibility. They are entrusted with ensuring that the information laid before the board by management
is an accurate reflection of their understanding of the affairs of the Company. Executive Directors need to strike a balance
between their management of the Company, and their fiduciary duties and concomitant independent state of mind required
when serving on the board.
•
Non‑Executive Directors – The Non‑Executive Director plays an important role in providing objective judgment
independent of management on issues facing the Company. Not being involved in the management of the Company defines
the director as non‑executive. Non‑Executive Directors are independent of management on all issues including strategy,
performance, sustainability, resources, transformation, diversity, employment equity, standards of conduct and evaluation
of performance. The Non‑Executive Directors should meet from time to time without the executive directors to consider
the performance and actions of executive management.
Remuneration framework
Opthea aims to reward its executives with a level and mix of remuneration appropriate to their position, skills, experience and
responsibilities, while being market competitive and enabling the Company to retain staff as well as structuring awards which
conserve cash reserves. Hence, a defined remuneration framework has been crafted for both Executive and Non‑Executive
Directors of the Company.
Remuneration framework for – Executive Directors
Fixed compensation
A level of fixed remuneration is set to provide a base level of compensation which is both appropriate to the position and is
competitive in the market. The remuneration committee accesses external advice independent of management if required.
No external advice has been sought during either 2023 or 2022.
Fixed compensation comprises salary, retirement benefits (superannuation/401k), and other benefits (like health, life insurance,
disability, etc.) are reviewed every 12 months by the remuneration committee. Group and individual performance are considered
during the annual remuneration review process.
Annual Report 2022 – 2023
33
Directors’ Report (cont.)
Performance linked compensation
The remuneration framework also incorporates “at risk” components, which are linked to the performance, through Short‑Term
and Long‑Term Incentives. Performance is assessed against a suite of measures relevant to the success of the group and
generating growth and returns for shareholders.
•
Short‑Term Incentives (STI): The objective of STI is to link the achievement of the Company’s operational targets with the
remuneration received by the executives charged with meeting those targets. The total potential STI available is set at a level
that provides sufficient incentive to the executive to achieve the operational targets at a cost to the Company that is
reasonable in the circumstances.
Actual STI payments in the form of cash bonuses to Key Management Personnel depend on the extent to which specific
targets set at the beginning of the financial year (or shortly thereafter) are met. The targets consist of a number of Key
Performance Indicators (KPIs) covering corporate objectives and individual measures of performance. Individual KPIs are
linked to the Company’s development plans.
On an annual basis, after consideration of performance against KPIs, the remuneration committee determines the amount,
if any, of the STI to be paid to KMP. Payments of the STI bonus are made in the following reporting period.
The remuneration committee considered the STI payment for the 2023 financial year in August 2023. Based on the
achievement of operational objectives in the financial year, the remuneration committee has determined there will be
US$354,954 STI bonus paid to KMP for the 2023 financial year (2022: US$261,456).
•
Long‑Term Incentive (LTI): The objective of the LTI is to reward KMP in a manner that aligns this element of compensation
with the creation of shareholder wealth. LTI grants are made to KMP and employees who are able to influence the generation
of shareholder wealth and have a direct impact on the Company’s performance and development. Option vesting conditions
are based on continued service to the Company by the KMP.
The Company implemented an LTI plan to attract, retain and motivate eligible employees, essential to the continued growth
and development of the Company. The LTI was approved by shareholders at the Company’s 2014 AGM. The limit of the
Company’s share capital to be granted under the LTI was increased to 10% at the 2016 EGM.
Remuneration framework for – Non‑Executive Directors
The renumeration for Non‑Executive Directors is restricted to fees which is determined based on the maximum aggregate
fee pool. Non‑Executive Directors remuneration is set annually by the Remuneration Committee through a process that uses
independent surveys to establish the market rate for Non‑Executive Directors’ remuneration in equivalent sized companies
operating in an equivalent or similar field. The Committee recognizes the need to attract and retain appropriately experienced
and qualified Board members and the increasing commitment of time required by each Board member in the current regulatory
environment. The fees also reflect the demands which are made on, and the responsibilities of, the Non‑Executive Directors,
whilst incurring a cost which is acceptable to shareholders.
Annual review
Non-Executive Directors’ fees and the aggregate fee pool are reviewed annually by the Remuneration Committee against
fees paid to Non-Executive Directors in a group of comparable peer companies within the biotechnology sector and relevant
companies in the broader US and ASX-listed market. The Chairman’s fees are determined by the Remuneration Committee
independently of the fees of Non-Executive Directors based on the same role, again using benchmarking data from comparable
companies in the relevant sector. The Board is ultimately responsible for approving any changes to Non-Executive Director fees,
upon consideration of recommendations put forward by the Remuneration Committee.
34
Opthea Limited
Directors’ Report (cont.)
Fee policy
Non‑Executive Directors’ fees consist of base fees and committee fees. The payment of committee fees recognizes the
additional time, responsibility and commitment required by Non‑Executive Directors who serve on board committees.
The Chairman of the Board is a member of all committees but does not receive any committee fees in addition to his base fee.
Non‑Executive Directors did not receive bonuses or forms of equity securities, or any performance‑related remuneration
during the financial year except where stipulated in the Remuneration table. Statutory superannuation contributions are required
under the Australian superannuation guarantee legislation to be paid on any fees paid to Australian directors. There are no
retirement allowances paid to non‑executive directors. The Non‑Executive Directors’ fees reported below include any statutory
superannuation contributions.
Consequences of performance on shareholder wealth
In considering the Company’s performance and benefits for shareholder wealth, the Remuneration Committee have regard
to operational contributions and the following indices in respect of the current and previous four financial years. Due to the
change in functional currency and presentation currency in the current year, the current and prior year has been restated to
US currency with the remaining years remaining in A$. Refer to Note 3 Change in presentation and functional currencies for
more information in regard to the determination of the change.
2023
US$
2022
US$
2021
A$
2020
A$
2019
A$
Revenue including finance income
3,335,902
326,151
440,615
539,514
914,840
Loss before tax
(142,521,085)
(99,116,657)
(50,283,342)
(16,831,966)
(35,547,034)
Tax benefit
5,926,350
6,299,286
4,938,846
5,708,767
14,636,973
Loss after tax
(142,521,085)
(92,817,371)
(45,344,496)
(11,123,199)
(20,910,061)
2022 and 2021 is US$ with remaining years presented in A$. Refer to Note 3 Change in presentation and functional currencies.
2023
US$
2022
US$
2021
A$
2020
A$
2020
A$
Basic loss per share
(0.32)
(0.26)
(0.14)
(0.04)
(0.09)
Net Tangible Asset (NTA) backing
per share @ June 30
(0.01)
0.14
0.58
0.17
0.12
Opthea share price @ June 30
A$0.55
A$1.10
A$1.35
A$2.36
A$0.67
Change in share price is one of the financial performance targets considered in setting STI.
Service contracts
Dr. Megan Baldwin, CEO and Managing Director, is employed under an ongoing contract that commenced on February 24, 2014.
Under the terms of the present contract (including any subsequent board approvals relating to fixed remuneration) Dr. Baldwin:
•
Receives fixed remuneration of A$575,000 per annum from July 1, 2022 ; and
•
May resign from her position and thus terminate this contract by giving three months’ notice.
On resignation, any unvested LTI options or conditional rights will be forfeited. The Company may terminate this employment
agreement by providing:
•
12 months’ notice; or
•
Payment in lieu of the notice period (as detailed above) based on the fixed component of Dr. Baldwin’s remuneration plus
implied bonus.
Annual Report 2022 – 2023
35
Directors’ Report (cont.)
On termination notice by the Company, any LTIP options that have vested or that will vest during the notice period will be
released. Options granted that have not yet vested will be forfeited.
The Company may terminate the contract at any time without notice if serious misconduct has occurred.
Where termination with cause occurs, Dr. Baldwin is only entitled to that portion of remuneration that is fixed, and only
up to the date of termination. On termination with cause, any unvested options will immediately be forfeited.
Timothy Morris, CFO, is employed under an ongoing contract and employment is at will. The Company may terminate the
employment without cause which provides a severance payment of 12 months base salary, 12 months of health care costs.
Receives fixed remuneration of US$475,000 per annum.
The Company may terminate Mr. Morris’ contract at any time without notice if serious misconduct has occurred. Where termination
with cause occurs, the executive is only entitled to that portion of remuneration that is fixed and only up to the date of termination.
Karen Adams, Vice President and Company Secretary, has an ongoing contract. The Company may terminate the employment
agreement by providing three months’ notice or providing payment in lieu of the notice period (based on the fixed component
of remuneration). Karen Adams may resign from her position and thus terminate this contract by giving three months’ notice.
The Company may terminate Karen Adams’s contract at any time without notice if serious misconduct has occurred.
Where termination with cause occurs, the executive is only entitled to that portion of remuneration that is fixed and only
up to the date of termination.
Judith Robertson, Chief Commercial Officer, has an ongoing contract and employment is at will. The Company may terminate
the employment without cause which provides a severance payment of 12 months base salary, 12 months of health care costs.
The Company may terminate Judith Robertson’s contract at any time without notice if serious misconduct has occurred.
Where termination with cause occurs, the executive is only entitled to that portion of remuneration that is fixed and only
up to the date of termination.
Non‑executive directors
The base non‑executive director fee is US$75,000 per annum for the Chairman, US$50,000 per annum for other US‑based
non‑executive directors, and A$65,700 per annum for all Australian‑based non‑executive directors. Base fees cover all main
board activities. Membership of board committees attract the following fees: Chair Audit and Risk US$20,000, Chair of
Nominations, Clinical and Remuneration US$10,000/A$13,140, and general committee fees of US$5,000/A$6,570 per annum.
Non‑executive directors are not provided with retirement benefits.
The Company implemented a Non‑Executive Director share and option plan (the “NED Plan”) following its approval at the 2014
AGM. Approval of further grant of options to non‑executive directors under the NED Plan was made at the 2018 AGM. Under
the NED Plan, present and future non‑executive directors may:
•
Elect to receive newly issued ordinary shares (Shares) or options to acquire newly issued Shares in lieu of receiving some
or all of their entitlement to their director’s existing cash remuneration (in accordance with article 61.8 of the
Company’s constitution);
•
Be awarded newly issued Shares or options to acquire newly issued Shares in lieu of additional cash remuneration in respect
of services provided to the Company which in the opinion of the Board are outside the scope of the ordinary duties of the
relevant director (in accordance with article 61.5 of the Company’s constitution); and/or
•
Otherwise be awarded newly issued Shares or options to acquire newly issued Shares as part of the directors’ remuneration
in addition to any existing cash remuneration paid to directors (if any).
36
Opthea Limited
Directors’ Report (cont.)
Advantages of the NED Plan are that it:
•
Assists the Company in preserving its cash for use towards advancing the Company’s lead molecule, OPT‑302, through
Phase 2 and Phase 3 clinical studies;
•
Gives non‑executive directors an opportunity to demonstrate their commitment and support for the Company through
sacrificing some or all of their director’s fees for Shares or options in Opthea; and
•
Provides the Company with further flexibility in the design of the directors’ remuneration packages and in turn assists the
Company with retaining existing directors and attracting new additional directors with the relevant experience and expertise,
in both cases to further advance the prospects of the Company.
Directors’ and executive officers’ remuneration
Details of the nature and amount of each major element of remuneration of each director and key management personnel
of the Company are:
Short-
Term
Short‑
Term
Post-
Emp
loyment
Long-
Term
Termin
ation
benefits
Share
based
payment
Salary
& Fees
US$
Cash
bonus1
US$
Benefits9
US$
Super
annu
ation
US$
Long
Service
Leave
US$
Termin
ation Pay
US$
Options
US$
Total
US$
Total
perform
ance
related %
Non‑Executive directors:
Jeremy Levin
2023
75,000
–
–
–
–
–
350,472
425,471
82%
2022
75,000
–
–
–
–
–
858,286
933,286
92%
Anshul
Thakral2
2023
3,159
–
–
–
–
–
–
3,159
0%
2022
–
–
–
–
–
–
–
–
0%
Michael
Sistenich3
2023
58,201
–
–
–
–
–
145,079
203,280
71%
2022
73,789
–
–
–
–
–
–
73,789
0%
Lawrence
Gozlan3
2023
230,644
–
–
–
–
–
493,665
724,309
68%
2022
70,201
–
–
–
–
–
586,271
656,472
89%
Daniel
Spiegelman
2023
75,000
–
–
–
–
–
487,695
562,695
87%
2022
75,000
–
–
–
–
–
696,217
771,217
90%
Julia Haller
2023
59,464
–
–
–
–
–
267,948
327,412
82%
2022
55,000
–
–
–
–
–
587,694
642,694
91%
Susan Orr4
2023
58,928
–
–
–
–
–
147,267
206,195
71%
2022
9,583
–
–
–
–
–
128,010
139,593
93%
Quinton
Oswald5
2023
55,096
–
––
–
–
–
147,267
202,363
73%
2022
9,583
–
–
–
–
–
128,010
137,593
93%
Judith
Robertson6
2023
–
–
–
–
–
–
–
–
0%
2022
27,500
–
–
–
–
–
358,633
386,133
93%
Sub‑total
Annual Report 2022 – 2023
37
Directors’ Report (cont.)
Short-
Term
Short‑
Term
Post-
Emp
loyment
Long-
Term
Termin
ation
benefits
Share
based
payment
Salary
& Fees
US$
Cash
bonus1
US$
Benefits9
US$
Super
annu
ation
US$
Long
Service
Leave
US$
Termin
ation Pay
US$
Options
US$
Total
US$
Total
perform
ance
related %
Non‑executive
directors
2023
615,492
–
–
–
–
–
2,039,392
2,654,884
77%
2022
395,656
–
–
–
–
–
3,343,121
3,738,777
89%
Executive directors:
Megan
Baldwin
2023
386,036
133,634
–
80,059
–
–
969,820
1,569,550
70%
2022
342,510
113,475
–
34,251
–
–
730,644
1,107,405
76%
Other Key Management Personnel:
Karen Adams
2023
224,126
44,290
–
36,729
–
–
202,452
507,597
49%
2022
211,035
27,981
–
21,104
–
–
119,147
379,267
39%
Timothy
Morris7
2023
327,628
36,630
40,058
–
–
–
370,630
774,946
53%
2022
–
–
–
–
–
–
–
–
–
Judith
Robertson6
2023
390,000
140,400
52,990
5,200
–
–
268,242
856,832
48%
2022
195,000
78,000
–
–
–
–
229,060
502,060
61%
Joel Naor8
2023
450,000
–
57,259
15,180
–
–
370,935
893,374
42%
2022
150,000
42,000
–
750
–
–
242,795
435,545
65%
Totals
2023
2,393,282
354,954
150,308
137,168
–
–
4,221,472
7,257,184
63%
2022
1,294,201
261,456
–
56,105
–
–
4,664,767
6,276,529
80%
1. Bonuses are paid in the financial year following the year in which they are earned.
2. Appointed June 7, 2023.
3. Resigned June 7, 2023.
4. Director appointed April 21, 2022.
5. Director appointed April 21, 2022.
6. Director resigned January 1, 2022, appointed CCO January 1, 2022.
7.
Appointed CFO October 24, 2022.
8. Appointed CMO March 1, 2022 Resigned July 15, 2023.
9.
Benefits are US Health Benefits paid for US staff only.
Equity instruments
All options refer to options over ordinary shares of Opthea Limited which are exercisable on a one‑for‑one basis under
the Long‑Term Incentive (LTIP) and Non‑executive Director share and options (NED) plans.
38
Opthea Limited
Directors’ Report (cont.)
Options over equity instruments granted as compensation
Details of options over ordinary shares in the Company that were granted as compensation to KMP during the reporting period
and details of options that vested during the reporting period are as follows:
During the financial year
Name
Number
of options
granted
Number
of options
vested1
Daniel Spiegelman
2,000,000
412,785
Lawrence Gozlan
2,000,000
412,785
Michael Sistenich (resigned June 7, 2023)
1,500,000
309,589
Megan Baldwin
3,000,000
619,178
1.
Options that are vested during the financial year were originally granted in the year ended June 30, 2023.
Options Granted during the year have the following fair values at grant date, US$0.705 (A$0.526), US$0.535 (A$0.397)
and US$0.675 (A$0.937) with the following exercise price US$0.948 (A$1.27), US$0.755 (A$1.01) and US$1.46 (A$2.03), for
Dr. Haller and Mrs. Robertson, Dr. Orr and Mr. Oswald and Mrs. Adams, respectively. All options expire on the earlier of their
expiry date or termination of the individual’s employment. Option vesting is conditional on the individual being employed or
in office. The options are exercisable up to three years after they vest.
Performance rights over equity instruments granted as compensation
Details of performance rights over ordinary shares in the Company that were granted as compensation to KMP during the
reporting period and details of rights that vested during the reporting period are as follows:
During the financial year
Name
Number
of options
granted
Number
of options
vested
Megan Baldwin
500,000
103,196
Karen Adams
150,000
30,958
Lawrence Gozlan
500,000
103,196
Daniel Spiegelman
150,000
30,958
Performance rights granted during the year have the following Fair value at Grant date US$0.955 (A$1.28) with a nil exercise
price. All rights have an expiry of 10 years or termination date of the individual’s employment. Rights vesting is conditional on
performance hurdles and being employed or in office.
Annual Report 2022 – 2023
39
Directors’ Report (cont.)
American depository security options over equity instruments granted as compensation
Details of American depository security options over ordinary shares in the Company that were granted as compensation
to KMP during the reporting period and details of ADS options that vested during the reporting period are as follows:
During the financial year
Name
Number of
options granted
Number of
options vested
Timothy Morris
300,000
–
American depository securities options granted during the year have the following fair value at grant date US$3.479 (2022:
US$4.116) with an exercise price of US$4.850 (2022: US$6.01). All ADS options have an expiry of 10 years or termination date
of the individual’s employment. ADS options vesting is conditional on the individual being employed or in office.
Exercise of options granted as compensation
During 2023, 2,033,852 shares were issued to KMP on the exercise of 6,000,000 of options previously granted
as compensation.
During 2023, 4,500,000 options were exercised by the following key management personnel using the cashless exercise
mechanism available under the LTIP and NED Plans. On the exercise of the options, the Company issued 533,852
ordinary shares.
The number of shares was determined by the value calculated between the market price of the shares (based on a volume
weighted average price (“VWAP”) for the 5 trading days prior to exercise date) of A$0.9708 for 4,500,000 options and A$0.855
exercise price for 1,500,000 options.
Name
No. of options
exercised
No. of ordinary
shares of
Opthea Limited
issued
Issue date
Amount
unpaid
Expiry date
of rights
Megan Baldwin
3,000,000
355,901
November 29 2018
$nil
November 29, 2022
Geoffrey Kempler
1,500,000
1,500,000
November 29, 2018
$nil
November 29, 2022
Michael Sistenich
1,500,000
177,951
November 29, 2018
$nil
November 29, 2022
6,000,000
2,033,852
40
Opthea Limited
Directors’ Report (cont.)
Details of options affecting current and future remuneration
Details of vesting profiles of the options held by each KMP of the Company are:
Number
of options
Grant date
%
Vested
%
Forfeited1
Financial years in
which grant vests
Vesting
conditions
Megan
Baldwin
3,000,000
November 29, 2018
100%
0%
July 1, 2019
Continued
service
3,000,000
November 16, 2022
0
0%
July 1, 2023-2026
Jeremy Levin
750,000
January 19, 2021
25%
0%
July 1, 2020
Continued
service
750,000
January 19, 2021
0%
0%
July 1, 2021
750,000
January 19, 2021
0%
0%
July 1, 2022
750,000
January 19, 2021
0%
0%
July 1, 2023
Michael
Sistenich
1,500,000
November 29, 2018
100%
0%
July 1, 2019
Continued
service
1,500,000
November 16, 2022
0
0%
July 1, 2023
Daniel
Spiegelman
500,000
October 12, 2020
100%
0%
July 1, 2020
Continued
service
500,000
October 12, 2020
100%
0%
July 1, 2021
500,000
October 12, 2020
100%
0%
July 1, 2022
500,000
October 12, 2020
0%
0%
July 1, 2023
2,000,000
November 16, 2022
0%
0%
July 1, 2023
Lawrence
Gozlan
500,000
October 12, 2020
100%
0%
July 1, 2020
Continued
service
500,000
October 12, 2020
100%
0%
July 1, 2021
500,000
October 12, 2020
100%
0%
July 1, 2022
500,000
October 12, 2020
0%
0%
July 1, 2023
2,000,000
November 16, 2022
0%
0%
July 1, 2023
Julia Haller
500,000
October 19, 2021
100%
0%
July 1, 2021
Continued
service
500,000
October 19, 2021
100%
0%
July 1, 2022
500,000
October 19, 2021
0%
0%
July 1, 2023
500,000
October 19, 2021
0%
0%
July 1, 2024
Susan Orr
250,000
April 24, 2022
100%
0%
July 1, 2022
Continued
service
250,000
April 24, 2022
100%
0%
July 1, 2023
250,000
April 24, 2022
0%
0%
July 1, 2024
250,000
April 24, 2022
0%
0%
July 1, 2025
Quinton
Oswald
250,000
April 24, 2022
100%
0%
July 1, 2022
Continued
service
250,000
April 24, 2022
100%
0%
July 1, 2023
250,000
April 24, 2022
0%
0%
July 1, 2024
250,000
April 24, 2022
0%
0%
July 1, 2025
1.
The percentage forfeited in the year represents the reduction from the maximum number of options available to vest due to vesting
criteria not being achieved.
Annual Report 2022 – 2023
41
Directors’ Report (cont.)
Number
of options
Grant date
%
Vested
%
Forfeited1
Financial years in
which grant vests
Vesting
conditions
Judith
Robertson
500,000
October 19, 2021
100%
0%
July 1, 2021
Continued
service
500,000
October 19, 2021
100%
0%
July 1, 2022
500,000
October 19, 2021
0%
0%
July 1, 2023
500,000
October 19, 2021
0%
0%
July 1, 2024
Karen Adams
200,000
June 6, 2022
100%
0%
July 1, 2022
Continued
service
200,000
June 6, 2022
100%
0%
July 1, 2023
200,000
June 6, 2022
0%
0%
July 1, 2024
200,000
June 6, 2022
0%
0%
July 1, 2024
1.
The percentage forfeited in the year represents the reduction from the maximum number of options available to vest due to vesting
criteria not being achieved.
Details of performance rights affecting current and future remuneration
Details of vesting profiles of the Performance rights held by each KMP of the Company are:
Number
of rights
Grant date
%
Vested
%
Forfeited1
Financial years in
which grant vests
Vesting
conditions
Megan
Baldwin
100,000
October 19, 2021
100%
0%
July 1, 2022
Continued
service
100,000
October 19, 2021
100%
0%
July 1, 2023
Continued
service
100,000
October 19, 2021
0%
0%
July 1, 2024
Continued
service
150,000
October 19, 2021
0%
0%
July 1, 2024
KPIs
150,000
October 19, 2021
0%
0%
July 1, 2024
KPIs
400,000
October 19, 2021
0%
0%
July 1, 2024
KPIs
400,000
October 19, 2021
0%
0%
July 1, 2024
KPIs
200,000
October 19, 2021
0%
0%
July 1, 2024
KPIs
500,000
November 16, 2022
100%
0%
July 1, 2023
Continued
service
Karen Adams
150,000
November 16, 2022
100%
0%
July 1, 2023
Continued
service
Lawrence
Gozlan
500,000
November 16, 2022
100%
0%
July 1, 2023
Continued
service
Daniel
Spiegelman
150,000
November 16, 2022
100%
0%
July 1, 2023
Continued
service
1.
The percentage forfeited in the year represents the reduction from the maximum number of options available to vest due to vesting criteria
not being achieved.
42
Opthea Limited
Directors’ Report (cont.)
Details of ADS options affecting current and future remuneration
Details of vesting profiles of the ADS options held by each KMP of the Company are:
Number of
ADS options
Grant date
%
Vested
%
Forfeited1
Financial years in
which grant vests
Vesting
conditions
Timothy
Morris
75,000
October 24, 2022
0%
0%
July 1, 2023
Continued
Service
75,000
October 24, 2022
0%
0%
July 1, 2024
Continued
service
75,000
October 24, 2022
0%
0%
July 1, 2025
Continued
service
75000
October 24, 2022
0%
0%
July 1, 2026
Continued
service
Joel Naor
75,000
March 1, 2023
100%
0%
July 1, 2022
Continued
service
6,250
monthly for
36 months
April 1, 2023
– Mar 1, 2026
8.33%
0%
July 1, 2023 – 2026
Continued
service
1.
The percentage forfeited in the year represents the reduction from the maximum number of options available to vest due to vesting
criteria not being achieved.
Options over equity instruments
The movement during the reporting period by number of rights and options over ordinary shares in Opthea Limited held directly,
indirectly or beneficially, by each KMP, including their related parties, is as follows:
Number
of options:
Held at
July 1
Granted as
compen
sation
Options
exercised
Lapsed
Forfeited
Held at
June 30
Vested
during
the year
Vested and
exercisable
Megan
Baldwin
2023
3,000,000
3,000,000
3,000,000
–
–
3,000,000
619,178
619,178
2022
3,000,000
–
–
–
–
3,000,000
–
3,000,000
Jeremy
Levin
2023
3,000,000
–
–
–
–
3,000,000
750,000
2,250,000
2022
3,000,000
–
–
–
–
3,000,000
750,000
1,500,000
Geoffrey
Kempler1
2023
1,500,000
–
1,500,000
–
–
–
–
–
2022
1,500,000
–
–
–
–
1,500,000
–
1,500,000
Daniel
Spiegelman
2023
2,000,000
2,000,000
–
–
–
4,000,000
912,785
1,912,785
2022
2,000,000
–
–
–
–
2,000,000
500,000
1,000,000
Lawrence
Gozlan
2023
2,000,000
2,000,000
–
–
–
4,000,000
912,785
1,912,785
2022
2,000,000
–
–
–
–
2,000,000
500,000
1,000,000
Michael
Sistenich
2023
1,500,000
1,500,000
1,500,000
–
–
1,500,000
309,589
309,589
2022
1,500,000
–
–
–
–
1,500,000
–
1,500,000
Julia Haller
2023
2,000,000
–
–
–
–
2,000,000
500,000
1,000,000
2022
2,000,000
–
–
–
–
2,000,000
500,000
500,000
1.
Geoffrey Kempler resigned October 12, 2020.
Annual Report 2022 – 2023
43
Directors’ Report (cont.)
Number
of options:
Held at
July 1
Granted as
compen
sation
Options
exercised
Lapsed
Forfeited
Held at
June 30
Vested
during
the year
Vested and
exercisable
Susan Orr
2023
1,000,000
–
–
–
–
1,000,000
250,000
500,000
2022
–
1,000,000
–
–
–
1,000,000
250,000
250,000
Quinton
Oswald
2023
1,000,000
–
–
–
–
1,000,000
250,000
500,000
2022
–
1,000,000
–
–
–
1,000,000
250,000
250,000
Other executives:
Karen
Adams
2023
800,000
‑
‑
–
–
800,000
400,000
400,000
2022
–
800,000
‑
–
–
800,000
200,000
200,000
Judith
Robertson
2023
2,000,000
–
–
–
–
2,000,000
500,000
1,000,000
2022
–
2,000,000
–
–
–
2,000,000
500,000
500,000
Total
2023
19,800,000
8,500,000
6,000,000
–
–
22,300,000
5,204,337
9,654,337
2022
13,000,000
6,800,000
–
–
–
19,800,000
3,450,000
11,200,000
Number of
performance
rights
Held at
July 1
Granted as
compen
sation
Rights
exercised
Lapsed
Forfeited
Held at
June 30
Vested
during the
year
Vested and
exercisable
Megan
Baldwin
2023
1,600,000
500,000
–
–
–
2,100,000
203,196
272,785
2022
–
1,600,000
–
–
–
1,600,000
69,589
69,589
Lawrence
Gozlan
2023
–
500,000
–
–
–
500,000
103,196
103,196
2022
–
–
–
–
–
–
–
–
Daniel
Spiegelman
2023
–
150,000
–
–
–
150,000
30,959
30,959
2022
–
–
–
–
–
–
–
–
Karen
Adams
2023
–
150,000
–
–
–
150,000
30,959
30,959
2022
–
–
–
–
–
–
–
–
Total
2023
1,600,000
1,300,000
–
–
–
2,900,000
368,311
437,900
2022
–
1,600,000
–
–
–
1,600,000
69,589
69,589
Number of
ADS options
Held at
July 1
Granted as
compen
sation
ADS
options
exercised
Lapsed
Forfeited
Held at
June 30
Vested
during the
year
Vested and
exercisable
Timothy
Morris
2023
–
300,000
–
–
–
300,000
–
–
2022
–
–
–
–
–
–
–
–
Joel Naor
2023
300,000
–
–
–
–
300,000
93,750
–
2022
–
–
–
–
–
–
–
–
Total
2023
300,000
300,000
–
–
–
600,000
93,750
–
2022
–
300,000
–
–
–
300,000
–
–
44
Opthea Limited
Directors’ Report (cont.)
Key management personnel transactions
Movements in shares
The movement during the reporting period in the number of ordinary shares in Opthea Limited held, directly, indirectly or
beneficially, by each KMP including their related parties is as follows:
Number of
Ordinary Shares:
Balance at
beginning of
period July 1
Granted as
remuneration
On Exercise of
Quoted Options
Purchased
in the year
Sold during
the year
Balance at
end of period
June 30
Non‑executive directors
Jeremy Levin
2023
–
–
–
31,496
–
31,496
2022
–
–
–
–
–
–
Geoffrey
Kempler1
2023
2,326,797
–
1,500,000
–
–
3,826,797
2022
2,326,797
–
–
–
–
2,326,797
Michael Sistenich
(resigned
June 7, 2023)
2023
1,233,097
–
177,951
–
–
1,411,048
2022
1,233,097
–
–
–
–
1,233,097
Daniel
Spiegelman
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Lawrence Gozlan
2023
1,877,357
–
–
–
–
1,877,357
2022
1,877,357
–
–
–
–
1,877,357
Julia Haller
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Susan Orr
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Quinton Oswald
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Anshul Thrakul
(appointed
June 7, 2023)
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Executives
Megan Baldwin
2023
3,839,398
–
355,901
–
–
4,195,299
2022
3,839,398
–
–
–
–
3,839,398
Karen Adams
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Judith Robertson
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Joel Naor
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Timothy Morris2
2023
–
–
–
–
–
–
2022
–
–
–
–
–
–
Total
2023
9,276,649
–
533,852
31,496
–
9,841,997
2022
9,276,649
–
–
–
–
9,276,649
1.
Geoffrey Kempler resigned as at October 12, 2020.
2. Appointed CFO October 24, 2022.
Annual Report 2022 – 2023
45
Directors’ Report (cont.)
This report has been signed in accordance with a resolution of the directors made pursuant to S.298 (2) of the Corporations
Act 2001 on September 28, 2023.
For and on behalf of the board:
Megan Baldwin
CEO & Managing Director
Opthea Limited
Melbourne
September 28, 2023
46
Opthea Limited
Management Team
Megan Baldwin
PhD, MAICD
Chief Executive Officer and
Managing Director
Dr. Megan Baldwin was appointed
CEO and Managing Director of Opthea
in February 2014.
Dr. Baldwin has over 20 years of
experience focusing on angiogenesis
and therapeutic strategies for ophthalmic
and cancer indications. Since joining
Opthea in 2008, she has held various
positions, including Head of Preclinical
R&D and Chief Executive Officer of
Opthea Pty Ltd, the 100% owned
subsidiary of Opthea, developing OPT‑302
for the treatment of wet age‑related
macular degeneration. Prior to joining
Opthea, Dr. Baldwin was employed
at Genentech (now Roche), the world
leader in the field of angiogenesis‑based
therapies for cancer and other diseases.
Her experience included several years
as a researcher in the group of leading
angiogenesis expert Napoleone Ferrara,
before moving to Genentech’s commercial
division and having responsibility for
corporate competitive intelligence
activities. In these roles, she developed
extensive commercial and scientific
knowledge in the field of anti‑angiogenic
and oncology drug development.
Megan holds a PhD in Medicine from
the University of Melbourne, having
conducted her doctoral studies at the
Ludwig Institute for Cancer Research.
Dr. Baldwin is on the board of Ausbiotech
and is a member of the Australian Institute
of Company Directors.
Timothy Morris
Chief Financial Officer
Timothy Morris was appointed Chief
Financial Officer of Opthea in October
2022. He has over 25 years of experience
in the role of Chief Financial Officer
with public biotechnology companies.
His financial and business development
experience spans clinical to commercial
stage companies engaged in developing
small molecules, biologics and cell therapy.
Previously, Mr. Morris was Chief Financial
Officer of Iovance Biotherapeutic
(NASDAQ:IOVA) which raised over
US$1 billion in four offerings to fund
expansion of the clinical development
program, build manufacturing capability
and to prepare for commercialization.
He serves as a Non-Executive Director
for DBV Technologies S.A., Aquestive
Therapeutics, Univercells S.A. and
Humanetics Corporation. Mr. Morris
holds a Bachelor of Science in Business
from California State University, Chico.
Karen Adams
B.BUS, CPA, GAICD, FCG, FGIA
Vice President Finance and
Company Secretary
Karen Adams was appointed Vice
President Finance in May 2021 and
Company Secretary in June 2021.
Karen is accountable directly to the
board, through the chair, on all matters
to do with the proper functioning of
Opthea’s board. Prior to joining Opthea,
Karen was the Chief Financial Officer of
the Victor Smorgon Group in Melbourne.
Karen has over 20 years’ experience
of financial management in board‑level
positions for private and listed companies
in Australia, UK, the US and Ireland.
Karen holds a Graduate Degree in
Business from Swinburne University
and is a member of the Australian Society
of Chartered Accountants, Graduate
of the Australian Institute of Company
Directors and a Fellow of the Institute
of Company Secretaries. Karen is also
the Company Secretary of the Company’s
subsidiary, Vegenics Pty Ltd.
Annual Report 2022 – 2023
47
Management Team (cont.)
Judith Robertson
MBA
Chief Commercial Officer
Judith Robertson was appointed
Chief Commercial Officer of Opthea
in January 2022.
Ms. Robertson was most recently
Chief Commercial Officer of Eleusis Ltd
and serves on the board of Durect
Corporation, a Nasdaq‑listed company
developing therapies for acute organ
injury and chronic liver diseases.
She was previously Chief Commercial
Officer of Aerie Pharmaceuticals where
she oversaw the launch of Rhopressa®,
the first product in 20 years to target
a new mechanism of action for the
treatment of glaucoma, and the launch
of the combination product Rocklatan®,
the first fixed‑dose combination of a
prostagland in and ROCK inhibitor for the
reduction of intraocular pressure (IOP)
in patients with open‑angle glaucoma
or ocular hypertension. Prior to Aerie,
Ms. Robertson was Vice President
Immunology and Ophthalmology Global
Commercial Strategy Leader at Johnson
and Johnson, Janssen Pharmaceuticals,
and Vice President, Ophthalmology Global
Business Franchise Head at Novartis
(formerly Alcon). Ms. Robertson’s prior
experience also includes sales and
marketing roles at Novartis, Bristol Myers
Squibb and Searle USA.
Ms. Robertson earned a BA with
honors from Ryerson University, Canada.
She also holds an MBA from Northwestern
University, Kellogg School of Management.
Bruno Gagnon
BPharm, MSc
Senior Vice President,
Global Clinical Operations
Mr. Gagnon was appointed Chief
Commercial Officer of Opthea in
July 2022.
Mr. Gagnon leads Global Clinical
Operations and was former Sr. Vice
President of Development Operations
at Eidos Therapeutics, a BridgeBio
company in San Francisco, CA. He also
served as Vice President of Clinical
Operations at BioMarin Pharmaceutical.
Previously, Mr. Gagnon held positions
of increasing responsibilities at Roche
Diagnostics, Chiron and Hoechst Marion
Roussel (now Sanofi). Over his 30‑year
career, functions under his leadership have
included Global Clinical Trial Management,
Patient Advocacy, Medical Writing,
Outsourcing and Contracts, Supply Chain
Management, Clinical Data Management,
Clinical Systems, Document Management
and Clinical Training.
Mr. Gagnon holds a bachelor’s degree from
the School of Pharmacy, Laval University
and a Master’s in Pharmaceutical Sciences
from University of Montreal, both in
Quebec, Canada.
Mike Gerometta
PhD
Head of CMC Development
Mike Gerometta has been Head of
Chemistry, Manufacturing & Controls
(CMC) Development for Opthea
since 2008 with responsibilities
encompassing outsourcing of Opthea’s
biopharmaceutical research and cGMP
manufacturing activities. Mike has over
30 years’ experience in the Australian
biotechnology industry, working with
numerous contract manufacturing
organizations overseas and locally in
all facets of translational CMC from
concept through to Phase 2 studies.
In this time, he has successfully guided
the manufacture of six biologics through
to the clinic, including oversight of four
nonclinical programs, as well as associated
global regulatory interactions.
Previously as Chief Operating Officer of
Q‑Gen, the manufacturing facility of the
Queensland Institute of Medical Research,
he restructured the service business to
align with QIMR’s strategic objectives.
Mike has also directed the development
of numerous in vitro diagnostic products
through to the market over 19 years at
Agen Biomedical, ultimately as Research
and Product Development Director.
Mike was awarded his PhD in
biotechnology from the Queensland
University of Technology and has a
degree in chemistry from the University
of Technology in Sydney.
48
Opthea Limited
Management Team (cont.)
Mark O’ Neill
MSc, B. Chem Eng
Vice President CMC
Mark O’Neill was appointed
Vice President CMC in January 2022.
Mr. O’Neill was most recently head of
Process Development for Avexis Gene
therapies where he orchestrated all
product development and technical
operations activities pertaining to the
startup and licensure of Zolgensma drug
substance manufacturing at the Colorado
site. Prior to Avexis, he was Vice President
and General Manager of the Thermo
Fisher Groningen Single Use Biologics
Manufacturing Facility in Groningen,
The Netherlands, where he oversaw all
operations including startup of commercial
manufacturing and initial commercial
licensure at the facility. Mr. O’Neill has
over 30 years of experience in the
manufacturing of biopharmaceuticals
including 20 years with Amgen where he
gained extensive experience in all aspects
of lifecycle management including Quality,
Engineering, Production, Development,
Supply Chain and Business Development.
Mark holds a Master of Science Degree
from Colorado School of Mines in
Environmental and Chemical Engineering
and a Bachelor’s of Science Degree
in Chemical Engineering from the
University of Colorado.
Ian Leitch
PhD
Director – Clinical Research
Ian Leitch has been Director of Clinical
Research of Opthea since September
2011. He has over 20 years of research
and management experience from drug
discovery through clinical development in
biotechnology/pharmaceutical companies.
For the five years prior to joining Opthea,
he was a member of the Medical Sciences
group at Amgen Inc in Thousand Oaks,
California, involved in the development of
novel therapeutics in Amgen’s oncology
pipeline. In his role as Senior Manager
in the Early Development Oncology
Therapeutic Area, he had responsibility
for the oversight, design, management
and execution of Phase 1‑2 clinical studies
in oncology.
Prior to joining Amgen, he spent eight
years at Miravant Medical Technologies
in Santa Barbara, California. He held
positions of increasing responsibility,
including Senior Program Manager for
Cardiovascular Research and Clinical Study
Director for Ophthalmology. At Miravant,
he managed preclinical efficacy studies,
developed relationships with Key Opinion
Leaders and designed Phase 1‑2 clinical
studies in a collaboration with the
cardiovascular device company Guidant
Inc. He previously held the position of
NHMRC Senior Research Officer at the
University of Newcastle and was based
at the John Hunter Hospital in Australia.
He received his BSc (Hons), PhD from the
Department of Pharmacology, Faculty of
Medicine, at Monash University and
completed part of the doctoral studies at
the University of California, Santa Barbara.
Annual Report 2022 – 2023
49
Financial Report
Contents
51
Consolidated Statement of Profit or Loss and Other Comprehensive Income
52
Consolidated Statement of Financial Position
53
Consolidated Statement of Changes in Equity
54
Consolidated Statement of Cash Flows
55
Notes to the Consolidated Financial Statements
90
Directors’ Declaration
91
Auditor’s Independence Declaration
92
Independent Auditor’s Report
97
Additional Information
98
ASX Additional Information
50
Opthea Limited
Consolidated Statement of Profit or Loss
and Other Comprehensive Income
For the year ended June 30, 2023
Note
2023
US$
2022
US$
Revenue
7
108,406
90,683
Other income
8
276,869
108,322
Research and development expenses
9
(122,128,314)
(78,654,217)
Patent and intellectual property expense
(166,826)
(160,501)
Interest expense on DFA*
12
(13,462,160)
(28,713)
Administrative expenses
10
(28,115,929)
(17,922,419)
Finance income
11
3,227,496
235,468
Fair value adjustment gain on DFA
13
12,302,160
–
Net foreign exchange loss
14
(489,137)
(2,813,993)
Loss before income tax
(148,447,435)
(99,116,657)
Income tax benefit
15
5,926,350
6,299,286
Loss for the year
(142,521,085)
(92,817,371)
Other comprehensive income
Items that will not be reclassified subsequently to profit or loss:
Fair value gains on investments in financial assets
–
–
Other comprehensive income for the year, net of tax
–
–
Total comprehensive loss for the year
(142,521,085)
(92,817,371)
Loss for the year is attributable to:
Owners of the Company
28
(142,521,085)
(92,817,371)
(142,521,085)
(92,817,371)
Total comprehensive loss for the year is attributable to:
Owners of the Company
(142,521,085)
(92,817,371)
(142,521,085)
(92,817,371)
Loss per share attributable to the owners of the Company:
– Basic and diluted loss per share (cents)
16
(32.20)
(26.40)
*
Development Funding Agreement (“DFA”).
The above consolidated statement of profit or loss and other comprehensive income should be read in conjunction with the
accompanying notes.
Annual Report 2022 – 2023
51
Consolidated Statement of Financial Position
At June 30, 2023
Note
2023
US$
2022
US$
Assets
Current assets
Cash and cash equivalents
17
89,188,713
44,631,293
Current tax receivable
15
5,926,350
6,299,286
Receivables
18
636,564
257,668
Prepayments
19
2,634,671
8,720,195
Total current assets
98,386,298
59,908,442
Non‑current assets
Equipment
33,035
28,082
Right‑of‑use asset
20
168,451
–
Prepayments
21
53,535
110,295
Total non‑current assets
255,021
138,377
Total assets
98,641,319
60,046,819
Liabilities
Current liabilities
Payables
22
17,891,854
11,445,498
Lease liabilities
97,485
–
Provisions
23
753,300
596,203
Total current liabilities
18,742,639
12,041,701
Non‑current liabilities
Lease liabilities
24
84,226
–
Financial liabilities
25
85,660,000
–
Provisions
26
7,631
27,974
Total non‑current liabilities
85,751,857
27,974
Total liabilities
104,494,497
12,069,675
Net assets
(5,853,178)
47,977,144
Equity
Contributed equity
27
320,883,552
235,277,217
Accumulated losses
28
(359,462,438)
(216,941,353)
Reserves
28
32,725,708
29,641,280
Total equity
(5,853,178)
47,977,144
The above consolidated statement of financial position should be read in conjunction with the accompanying notes.
52
Opthea Limited
Consolidated Statement of Changes in Equity
For the year ended June 30, 2023
Note
Contributed
equity
US$
Pre‑funded
warrants
US$
Share‑based
payments
reserve
US$
Fair value of
investments
reserve
US$
FX
translation
reserve
US$
Accumulated
losses
US$
Total
equity
US$
As at July 1, 2021
234,147,526
–
4,087,650
1,085,411
20,089,163 (124,123,982) 135,285,768
Loss for the year*
–
–
–
–
–
(92,817,371)
(92,817,371)
Total comprehensive
income and expense
for the period
–
–
–
–
–
(92,817,371)
(92,817,371)
Recognition
of share‑based
payment
28
–
–
5,251,572
–
–
–
5,251,572
Issue of ordinary
shares on the
exercise of options
27
1,129,691
–
(872,516)
–
–
–
257,175
Balance at
June 30, 2022
235,277,217
–
8,466,706
1,085,411
20,089,163 (216,941,353)
47,977,144
As at July 1, 2022
235,277,217
–
8,466,706
1,085,411
20,089,163 (216,941,353)
47,977,144
Loss for the year*
–
–
–
–
– (142,521,085) (142,521,085)
Total comprehensive
income and expense
for the period
–
–
–
–
– (142,521,085) (142,521,085)
Issuance of
ordinary shares
81,815,357
–
–
–
–
–
81,815,357
Recognition
of share‑based
payment
28
–
–
5,834,686
–
–
–
5,834,686
Issue of ordinary
shares on the
exercise of options
27
3,790,978
–
(2,750,258)
–
–
–
1,040,720
Balance at
June 30, 2023
320,883,552
–
11,551,134
1,085,411
20,089,163 (359,462,438)
(5,853,178)
*
Amounts are after tax.
The above consolidated statement of changes in equity should be read in conjunction with the accompanying notes.
Annual Report 2022 – 2023
53
Consolidated Statement of Cash Flows
For the year ended June 30, 2023
Note
2023
US$
2022
US$
Cash flows from operating activities
Interest received
3,121,594
216,422
Royalty and license income received
3,826
90,683
Grant and other income
276,869
455,807
Payment of lease interest
(17,148)
(5,920)
Payments to suppliers, employees and for research & development
and intellectual property costs (inclusive of GST)
(130,292,806)
(77,064,842)
Research and development tax incentive scheme credit received in cash
6,299,286
4,972,898
Net cash flows used in operating activities
31
(120,608,379)
(71,334,952)
Cash flows from investing activities
Purchase of equipment
(21,954)
(16,910)
Net cash flows used in investing activities
(21,954)
(16,910)
Cash flows from financing activities
Payment of lease liabilities
(70,966)
(85,578)
Net proceeds on issue of shares
81,815,358
–
Net proceeds under the Development Funding Agreement
25
84,500,000
–
Cash received for ordinary shares issued on exercise of options
27
1,040,718
257,175
Net cash flows provided by financing activities
167,285,110
171,597
Net increase/(decrease) in cash and cash equivalents
46,654,777
(71,180,265)
Effects of exchange rate changes on the balance of cash held in
foreign currencies
(2,097,357)
(2,381,619)
Cash and cash equivalents at beginning of year
44,631,293
118,193,177
Cash and cash equivalents at the end of the year
17
89,188,713
44,631,293
The above consolidated statement of cash flows should be read in conjunction with the accompanying notes.
54
Opthea Limited
Notes to the Consolidated Financial Statements
1. Reporting Entity
Opthea Limited (the Company) is a listed public company incorporated in Australia. The address of its registered office and
principal place of business is: Suite 0403, Level 4, 650 Chapel Street, South Yarra, VIC 3141, Australia. These consolidated
financial statements comprise the Company and its subsidiaries (together referred to as the Group).
The Group’s principal activity is the development of new drugs for the treatment of eye diseases.
2. Basis of accounting
These financial statements are general purpose financial statements which have been prepared in accordance with the
Corporations Act 2001, Australian Accounting Standards and Interpretations, and comply with other requirements of the law.
The financial statements comprise the consolidated financial statements of the Group. For the purposes of preparing the
consolidated financial statements, the Company is a for‑profit entity.
Compliance with Australian Accounting Standards ensures that the financial statements and notes of the Company and the
Group comply with International Financial Reporting Standards (IFRS).
The financial statements were authorized for issue by the directors on August 31, 2023.
Going Concern
For the year ended June 30, 2023, the Group incurred a loss after income tax of $142,521,085 (2022: $92,817,371) and had
net cash outflows from operating activities of $120,608,379 (2022: $71,334,952). As at June 30, 2023, the Group had cash
and cash equivalents of $89,188,713 (2022: $44,631,293), net current assets of $79,643,659 (2022: $47,866,741), and was
in a negative net asset position of $ 5,853,178 (2022: positive $47,977,144).
The consolidated financial statements have been prepared on a going concern basis, which contemplates continuity of normal
activities and realization of assets and settlement of liabilities in the normal course of business. As the Group is still in the
research and development phase, the ability of the Group to continue its development activities as a going concern is dependent
upon it deriving sufficient cash from investors and from funding provided under the Development Funding Agreement (‘DFA
or Agreement’) with Carlyle and Abingworth. Of the initial total funding of US$120 million, US$50 million was received by the
Group in September 2022 and another US$35 million was received in December 2022. The Group expects to receive the
remaining US$35 million no later than December 31, 2023.
Subsequent to June 30, 2023, the Group was notified that a new co‑investor of Carlyle and Abingworth intends to participate
in a funding under the DFA of US$50 million to increase total DFA funding from US$120 million to US$170 million, which is subject
to the co‑investor’s final due diligence and receipt of regulatory and tax approvals, appropriate documentation and compliance
with closing conditions. Upon completion of the final due diligence, receipt of regulatory and tax approvals, execution of the
appropriate documentation and satisfaction of the closing conditions, the Group expects to receive the additional US$50 million.
While the Group anticipates that the due diligence will be completed to the satisfaction of the co‑investor, the necessary approvals
will be obtained, the appropriate documentation will be executed and that all closing conditions will be satisfied, there is no
assurance that the Group will ultimately receive the additional US$50 million. If the additional US$50 million is not received
by June 30, 2024, the Group will need to raise additional funds or reduce expenditures to continue as a going concern.
Concurrently with the receipt of the notice from the co-investor to increase its investment, the Group entered into binding
commitments for the private placement of ordinary shares and entitlement rights and accompanying options for aggregate gross
proceeds of approximately A$90 million (US$58 million) (the ‘Equity Financing’). The Equity Financing consists of two closings,
of which the first closing of A$73 million (US$47 million) consisting of a placement offering and an acceleration portion of an
Accelerated Non-Renounceable Entitlement Offer (“ANREO”) occurred on September 1, 2023. The second closing of A$17 million
(US$11 million), representing the remaining institutional and retail portion of the ANREO, on September 20, 2023. The shares
were issued and cash received on September 20, 2023. See Note 37, Events after the balance sheet date, for further information.
Annual Report 2022 – 2023
55
Notes to the Consolidated Financial Statements (cont.)
While we expect that with our cash on hand at June 30, 2023 of $89 million, together with the net proceeds from the Equity
Offering and the $85 million expected under the Funding Agreement, we will be able to fund our operations through the third
calendar quarter of 2024, such proceeds will not be sufficient to fully fund all anticipated costs of the Phase 3 clinical trials to
top-line data. We will need to raise significant funds to complete the efficacy and safety phase of both studies and to report
top-line data.
The Directors and management have considered the cash flow forecasts including the funding requirements of the business as
well as the funding expected to be raised through the Agreement and Offer. They have also considered the Group’s key risks and
uncertainties affecting the likely development of the business, as well as the conditions set forth in the Agreement. Based on this
assessment, the Directors and management believe that the conditions in the DFA can be met and that the Group has adequate
resources to continue normal activities and realize its assets and settle its liabilities in the normal course of business. Accordingly,
the directors have prepared the financial statements on the going concern basis.
Should the Group not be able meet the conditions in the DFA to increase the total funding from US$120 million to US$170 million,
the Group will need to raise additional funds or reduce expenditures to continue as a going concern. Based on that, a material
uncertainty exists which may cast significant doubt as to whether the Group will continue as a going concern. The financial
statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or to the
amounts and classification of liabilities that might be necessary should the Group not continue as a going concern.
3. Summary of accounting policies
The consolidated financial statements have been prepared using the significant accounting policies and measurement bases
summarized below.
Basis of measurement
The consolidated financial statements have been prepared on a historical cost basis, except for the investments classified
as financial assets, which have been measured at fair value. All amounts are presented in United States dollars unless
otherwise stated.
Functional currencies
An entity’s functional currency is the currency of the primary economic environment in which the entity operates. The Group’s
functional currency is US dollars.
Change in presentation of Other income
In the current financial year the Group changed its presentation of Other income by reclassifying interest income out of
Other income and into Finance Income – interest income to better reflect the nature of the related amounts as finance income.
This reclassification had no effect on the reported results of operations. The comparative year has also been reclassified.
Basis of consolidation
The consolidated financial statements incorporate the financial statements of the Company and its subsidiaries. Control is achieved
when the Company:
•
Has power over the investee;
•
Is exposed, or has rights, to variable returns from its involvement with the investee; and
•
Has the ability to use its power to affect its returns.
Consolidation of a subsidiary begins when the Company obtains control over the subsidiary and ceases when the Company
loses control of the subsidiary.
All intragroup assets and liabilities, equity, income, expenses and cash flows relating to transactions between members of the Group
are eliminated in full on consolidation.
56
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
Foreign currency translation
i.
Functional and presentation currency
As at January 1, 2021 it was determined that the Group’s functional and presentation currency had changed from Australian
dollars to United States dollars. Therefore, the functional and presentation currency of the Group is United States dollars (US$).
ii. Transactions and balances
Transactions in foreign currencies are initially recorded in the functional currency by applying the exchange rates ruling at
the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are retranslated at the rate
of exchange ruling at the reporting date.
Non‑monetary items that are measured in terms of historical cost in a foreign currency are translated using the exchange rate
as at the date of the initial transaction. Non‑monetary items measured at fair value in a foreign currency are translated using
the exchange rates at the date when the fair value was determined.
Financial assets and liabilities
Recognition and derecognition of financial assets
Purchases and sales of financial assets that require delivery of assets within the time frame generally established by regulation
or convention in the marketplace are recognized on the trade date, i.e., the date that the Group commits to purchase the asset.
Financial assets are derecognized when the right to receive cash flows from the financial assets has expired or when the entity
transfers substantially all the risks and rewards of the financial assets. If the entity neither retains nor transfers substantially all
of the risks and rewards, it derecognizes the asset if it has transferred control of the assets.
When financial assets are recognized initially, they are measured at fair value, plus directly attributable transaction costs.
Cash and cash equivalents
Cash and cash equivalents in the statement of financial position comprise cash at bank and in hand and short‑term deposits with
an original maturity of three months or less that are readily convertible to known amounts of cash and which are subject to an
insignificant risk of changes in value.
For the purposes of the statement of cash flows, cash and cash equivalents consist of cash and cash equivalents as defined above.
Other receivables
Other receivables generally comprise bank interest receivable, other receivables from external parties and Goods and Services
Tax (GST) credits receivable and are recognized and carried at original invoice amount less an allowance for any uncollectible
amounts. The amounts are usually received within 30 to 60 days of recognition.
The Group measures the loss allowance for receivables at an amount equal to lifetime expected credit losses (ECL). The ECL on
receivables are estimated under the simplified approach as permitted under AASB 9 Financial Instruments. This uses a provision
matrix by reference to past experience of the debtor and an analysis of the debtor’s current financial position, adjusted for factors
that are specific to the debtors and general economic conditions of the industry in which the debtors operate.
The Group writes off a receivable when there is information indicating that the debtor is in severe financial difficulty and there
is no realistic prospect of recovery.
Investments
Investments in financial assets comprise of the Group’s non‑current investments in listed companies.
On initial recognition, the Group may make an irrevocable election (on an instrument‑by‑instrument basis) to designate investments
in equity instruments as fair value through other comprehensive income (FVTOCI). Designation at FVTOCI is not permitted if the
equity instrument is held for trading.
Annual Report 2022 – 2023
57
Notes to the Consolidated Financial Statements (cont.)
Investments in equity instruments at FVTOCI are initially measured at fair value plus transaction costs. Subsequently, they are
measured at fair value with gains or losses arising from changes in the fair value recognized in other comprehensive income and
accumulated in the fair value of investments reserve. The fair values of investments in financial assets that are actively traded
in organized financial markets is determined by reference to quoted market bid prices at the close of business on the reporting
date. The cumulative gain or loss is not reclassified to profit or loss on disposal of the equity instruments.
Dividends on these investments in equity instruments are recognized in profit or loss in accordance with Australian
Accounting Standards.
Finance income
Almost all of the Group’s finance income is earned on short‑term bank deposits, and as such, finance income is recognized when
the Group’s right to receive the payment is established.
Payables
Payables are carried at amortized cost and due to their short‑term nature, they are not discounted. They represent liabilities
for goods and services provided to the Group prior to the end of the financial year that are unpaid and arise when the Group
becomes obliged to make future payments in respect of the purchase of these goods and services.
The amounts are unsecured and are usually paid within 30 days of recognition.
Financial liabilities
Financial liabilities are recognized in the Group’s statement of financial position when the Group becomes a party to the
contractual provisions of the instrument. Financial liabilities are initially measured at fair value. Transaction costs that are directly
attributable to the acquisitions or issue of financial liabilities (other than financial liabilities at fair value through profit or loss)
are deducted from the fair value of the financial liabilities, as appropriate, on initial recognition. Subsequent measurement
of the liability will be at its amortized cost, subject to any re‑measurement of the obligation for changes in assumptions.
Amortized cost and effective interest method
The effective interest method is a method of calculating the amortized cost of an instrument and of allocating interest expense
over the relevant period. The effective interest rate is the rate that exactly discounts estimated future cash payments through
the expected life of the financial liability, or (where appropriate) a shorter period, to the amortized cost of the financial liability.
Interest expense is recognized in profit and loss and is included in the “Interest expense on DFA” line item.
Revaluation
At every reporting period, the Company will review the expected approval and commercial launch dates. If the dates are delayed
from those used at previous reporting period, it is expected that a revaluation will result in another non‑cash gain. If the timelines
for approval and launch are accelerated, the Company would anticipate a revaluation resulting in a non‑cash charge to be
recognized on the Profit and Loss statement. The gains or losses are unrealized.
Equipment
Equipment is stated at historical cost less accumulated depreciation and any accumulated impairment losses. Depreciation
is calculated on a straight‑line basis over their useful economic lives as follows:
•
Equipment and furniture – 3 to 10 years; and
•
Leasehold improvements – 8 years or the term of the lease if shorter.
The assets’ residual values, useful lives and amortization methods are reviewed, and adjusted if appropriate, at each financial
year end.
An item of plant and equipment is derecognized upon disposal or when no further economic benefits are expected from its
use or disposal.
58
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
Research and development costs
Research costs are expensed as incurred. An intangible asset arising from the development expenditure on an internal project
will only be recognized when the Group can demonstrate the technical feasibility of completing the intangible asset so that it
will be available for use or sale, its intention to complete and its ability to use or sell the asset, how the asset will generate future
economic benefits, the availability of resources to complete the development and the ability to measure reliably the expenditure
attributable to the intangible asset during its development.
As of June 30, 2023 and 2022, the Group is in the research phase and has not capitalized any development costs to date.
Provisions and employee benefits
i.
Wages, salaries, annual leave and sick leave
Liabilities for wages and salaries, including non‑monetary benefits and annual leave expected to be settled within 12 months
of the reporting date are recognized in current provisions in respect of employees’ services up to the reporting date. They
are measured at the amounts expected to be paid when the liabilities are settled. Expenses for non‑accumulating sick leave
are recognized when the leave is taken and are measured at the rate paid or payable.
ii. Long service leave
The liability for long service leave is recognized in the provision for employee benefits and measured as the present value of
expected future payments to be made in respect of services provided by employees up to the reporting date. Consideration
is given to expected future wage and salary levels, experience of employee departures, and periods of service. Expected
future payments are discounted using market yields at the reporting date on bonds with terms to maturity that match, as
closely as possible, the estimated future cash outflows.
Share‑based payment transactions
The Group provides benefits to directors and employees (including key management personnel) of the Group in the
form of share‑based payments, whereby employees render services in exchange for shares or rights over shares
(equity‑settled transactions).
The cost of these equity‑settled transactions with employees is measured by reference to the fair value at the date at which
they are granted. Binomial models are used to value the options issued.
The cost of the equity‑settled transactions is recognized, together with a corresponding increase in equity, over the period in
which the performance conditions are considered achievable (the vesting period), ending on the date on which the relevant
employees become fully entitled to the award (the vesting date).
The charge to profit or loss for the period is the cumulative amount less the amounts already charged in previous periods.
There is a corresponding credit to equity.
Until an award has vested, any amounts recorded are contingent and will be adjusted if more or fewer awards vest than were
originally anticipated to do so.
Contributed equity
Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown
in equity as a deduction, net of tax, from the proceeds.
Annual Report 2022 – 2023
59
Notes to the Consolidated Financial Statements (cont.)
Revenue recognition
License revenue in connection with licensing of the Group’s intellectual property (including patents) to customers is recognized
as a right to use the Group’s intellectual property as it exists at the point in time in which the license is granted. This is because
the contracts for the license of intellectual property are distinct and do not require, nor does the customer reasonably expect,
that the Group will undertake further activities that significantly affect the intellectual property to which the customer has the
rights. Although the Group is entitled to sales‑based royalties from the eventual sales of goods and services to third parties using
the intellectual property licensed, these royalty arrangements do not in themselves indicate that the customer would reasonably
expect the Group to undertake such activities, and no such activities are undertaken or contracted in practice. Accordingly,
the promise to provide rights to the Group’s intellectual property is accounted for as a performance obligation satisfied at
a point in time.
The following consideration is received in exchange for licenses of intellectual property:
•
Up‑front license fees – these are fixed amounts and are recognized at the point in time when the Group transfers the
intellectual property to the customer.
•
Sales‑based royalties – these are variable consideration amounts promised in exchange for the license of intellectual property
and are recognized when the sales to third parties occur given the performance obligation to transfer the intellectual
property to the customer is already satisfied.
During the years ended June 30, 2023 and 2022, the Group’s only revenue related to sales‑based royalties.
Income tax
Current tax
Current tax assets and liabilities for the current and prior periods are measured at the amount expected to be recovered from
or paid to the taxation authorities based on the current period’s taxable income.
The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted by the
reporting date.
Research and development tax incentive
The Research and Development (R&D) Tax Incentive Scheme is an Australian Federal Government program under which eligible
companies with annual aggregated revenue of less than A$20 million can receive cash amounts equal to 43.5% of eligible
research and development expenditures from the Australian Taxation Office (ATO). The R&D Tax Incentive Scheme incentive
relates to eligible expenditure incurred in Australia and, under certain circumstances, overseas on the development of the Group’s
lead candidate, OPT‑302. The R&D tax incentive is applied annually to eligible expenditure incurred during the Group’s financial
year following annual application to AusIndustry, an Australian governmental agency, and subsequent filing of its Income Tax
Return with the ATO after the financial year end.
The Group estimates the amount of R&D tax incentive after the completion of the financial year based on eligible Australia
and overseas expenditures incurred during that year.
The Group has presented incentives in respect of the R&D Tax Incentive Scheme within income tax benefit in the Statement
of Profit or Loss and Other Comprehensive Income by analogizing with AASB 112 Income Taxes.
Deferred tax
Deferred income tax is provided on all temporary differences at the reporting date between the tax bases of assets and liabilities
and their carrying amounts for financial reporting purposes.
Deferred income tax liabilities are recognized for all taxable temporary differences except when the deferred income tax liability
arises from the initial recognition of goodwill or of an asset or liability in a transaction that is not a business combination and that,
at the time of the transaction, affects neither the accounting profit nor taxable profit or loss.
60
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
Deferred income tax assets are recognized for all deductible temporary differences, carry forward of unused tax assets (or credits)
and unused tax losses, to the extent that it is probable that taxable profit will be available against which the deductible temporary
differences, and the carry forward of unused tax credits and unused tax losses can be utilized, except when the deferred income
tax asset relating to the deductible temporary differences arises from the initial recognition of an asset or liability in a transaction
that is not a business combination and, at the time of the transaction, affects neither the accounting profit or taxable profit
or loss.
The carrying amount of deferred income tax assets is reviewed at each reporting date and reduced to the extent that it is no
longer probable that sufficient taxable profit will be available to allow all or part of the deferred income tax asset to be utilized.
Unrecognized deferred income tax assets are reassessed at each reporting date and are recognized to the extent that it has
become probable that future taxable profit will allow the deferred tax asset to be recovered.
Deferred income tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset
is realized or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted at
balance date.
Income taxes relating to items recognized directly in equity are recognized directly in equity and not in profit or loss.
Tax consolidation legislation
Tax consolidation is a system adopted by the ATO that treats a group of entities as a single entity for tax purposes. Opthea Limited
and its 100% owned Australian domiciled subsidiary formed a tax consolidated group effective July 1, 2003. The head entity,
Opthea Limited, and its controlled entity, Vegenics Pty Ltd, are current members of the tax consolidated group and account for
their own current and deferred tax amounts. Members of the tax consolidated group have adopted the “separate taxpayer within
group” method to allocate the current and deferred tax amounts to each entity within the Group.
This method requires adjustments for transactions and events occurring within the tax consolidated group that do not give rise
to a tax consequence for the Group or that have a different tax consequence at the level of the Group.
The head entity, which is the parent entity, in assuming the net unused tax losses and unused relevant tax credits, has recognized
reductions to investments in subsidiaries and where the amount of tax losses assumed is in excess of the carrying value of the
investment, the parent has recognized the difference as a distribution from subsidiaries in profit or loss.
Other taxes
Revenues, expenses, assets and liabilities are recognized net of the amount of GST except:
•
When the GST incurred on a purchase of goods and services is not recoverable from the taxation authority, in which case
the GST is recognized as part of the cost of acquisition of the asset or as part of the expense item as applicable; and
•
Receivables and payables are stated with the amount of GST included.
The net amount of GST recoverable from, or payable to the taxation authority is included as part of receivables or payables
in the statement of financial position.
Cash flows are included in the statement of cash flows on a gross basis and the GST component of cash flows arising from
investing and financing activities, which is recoverable from, or payable to, the taxation authority is classified as part of operating
cash flows.
Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the taxation authority.
4. Critical accounting judgments and key sources of estimation uncertainty
In applying the Group’s accounting policies, management continually evaluates judgments, estimates and assumptions based
on experience and other factors, including expectations of future events that may have an impact on the Group. All judgments,
estimates and assumptions made are believed to be reasonable based on the most current set of circumstances available to
management. Actual results may differ from the judgments, estimates and assumptions.
Annual Report 2022 – 2023
61
Notes to the Consolidated Financial Statements (cont.)
Significant judgments, estimates and assumptions made by management in the preparation of these financial statements are
outlined below:
4.1 Critical judgments in applying accounting policies
Research and development costs
The majority of Opthea’s expenditure is incurred as a result of clinical trials for OPT‑302. During the years ended June 30, 2023
and 2022, Opthea progressed Phase 3 wet age‑related macular degeneration (wet AMD) trials. A key measure of Opthea’s
performance is the level of expenditure incurred on the research of OPT‑302.
Judgment is required in relation to:
•
The classification of expenses in the income statement between research and development costs and operating expenses; and
•
Whether costs relate to R&D, and consequently if they meet the capitalization criteria under AASB 138 Intangible Assets.
The directors have determined that the Group is still in a research phase and accordingly, no development costs have been
capitalized as of June 30, 2023 and 2022.
Taxation
Research and development tax incentive
The Research and Development (R&D) Tax Incentive Scheme is an Australian Federal Government program under which eligible
companies can receive cash refunds of 43.5% of eligible R&D expenditure. Judgments are required as to the R&D tax incentive
refundable offset eligibility in respect of:
•
The Group’s ability to make claims and its continued compliance under the scheme;
•
R&D and other supporting costs previously approved by Australian tax authorities; and
•
Estimated amounts, timing and geographical location of costs related to the projects for which applications have been
approved to date; and Assessment of whether expenditure on projects for which approval has been given by Australian
tax authorities relate to Australian or overseas expenditure.
For the years ended June 30, 2023 and 2022, the Group has recognized an R&D tax incentive receivable of $6 million and
$6.3 million respectively within the Consolidated Statement of Financial Position, with a corresponding amount recognized
within income tax benefit within the Consolidated Statement of Profit or Loss and Other Comprehensive Income.
The R&D tax incentive receivable as at June 30, 2023 and 2022 is based on the legislation as currently enacted as at
June 30, 2023 and 2022, respectively. Any proposed changes to the legislation, such as rate changes and eligibility requirements,
may have a retrospective impact if the legislation is passed. During the year, no such changes have occurred.
Investment tax credits such as the R&D tax incentive are outside of the scope of AASB 112 Income Taxes and AASB 120
Accounting for Government Grants and Disclosure of Government Assistance. Based on the guidance in AASB 108 Accounting
Policies, Changes in Accounting Estimates and Errors, companies need to make an accounting policy choice on how to present
these incentives, which in practice is done by either analogizing with AASB 112 or with AASB 120.
In the Group’s opinion, the R&D tax incentive should be presented by analogizing to AASB 112 because the nature of the
incentive is considered to be more closely aligned to income taxes, based on the following considerations:
•
The R&D tax incentive is considered an income tax offset which will be offset against the Group’s tax obligation if and when
the Group returns to a net tax payable position. In addition, whilst the Group is currently eligible to receive cash payments
under the scheme since its consolidated revenue is currently below $20 million, if and when the Group generates revenue
in excess of $20 million the R&D tax incentive will become non‑refundable and can only be offset against any future income
tax payable by the Group.
•
The ATO, which is the tax authority in Australia, manages the annual claims process as the R&D tax incentive is included
in the Group’s annual income tax return.
The ATO is also responsible for making the R&D tax incentive cash payment if a company is eligible for a cash refund under
the program, oversees compliance with the requirements of the R&D tax incentive scheme and performs pre‑issuance reviews.
62
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
Income tax
The Group’s accounting policy for taxation requires judgments as to the differences between tax and accounting treatments
of income and costs recognized in the Consolidated Statement of Profit or Loss and Other Comprehensive Income. Judgment is
also required in assessing whether deferred tax assets and liabilities are recognized in the statement of financial position and if
accumulated income tax losses can be used to offset potential future tax profits.
Functional currency
Effective January 1, 2021 the Group’s functional currency changed from Australian dollars to US dollars as disclosed in Note 3.
The Group’s assets, liabilities and equity which were previously denominated in Australian dollars were translated into US dollars
on the date the functional currency changed.
Significant judgment is required in determining the currency of the primary economic environment in which the Group operates,
which requires an evaluation of various indicators related to the Group’s underlying transactions, events and conditions as they
relate to generating and expending cash.
4.2 Key sources of estimation uncertainty
Development Funding – Financial liability
The Group evaluated the Financing Agreement and determined it to be a research and development funding arrangement
with the characteristics of a debt instrument, as the transfer of financial risk to Launch Tx was not considered substantive and
genuine. Accordingly, the Group has recorded payments received under the Financing Agreement as part of a development
financing liability in its consolidated balance sheet. The Group measures the overall development financing liability at amortized
cost based on the estimated timing of regulatory approval and attainment of certain sales milestones and the contractual success
fee payments expected to be due therefrom, as discounted using an imputed interest rate. The development financing liability
will be accreted as interest expense to its expected future repayment amount over the expected life of the agreement using
the effective interest rate method. If the dates are delayed from those used at reporting date, it is expected that a fair value
adjustment will result in a non-cash gain. If the timelines for approval and launch are accelerated, the Group would anticipate
a fair value adjustment resulting in a non-cash charge to be recognized in the Consolidated Statement of Profit or Loss.
Share‑based payment transactions
The Group measures the cost of equity‑settled transactions with employees by reference to the fair value of the equity
instruments at the date at which they are granted. Fair values are determined internally using Binomial models. The related
assumptions are detailed in Note 35. The accounting estimates and assumptions relating to equity‑settled share‑based payments
have no impact on the carrying amounts of assets and liabilities in future reporting periods but may impact expenses and equity.
Should one or more of the assumptions and estimates used in estimating the fair value of share‑based payments change, this
could have a material impact on the amounts recognized in equity and employee‑related expenses.
5. Application of new and revised Accounting Standards
New and amended Accounting Standards that are effective for the current year
The Group has adopted all of the new and revised Standards and Interpretations issued by the Australian Accounting Standards
Board (the AASB) that are relevant to its operations and effective for the current year. New and revised Standards and
amendments thereof and Interpretations effective for the current year that are relevant to the Group.
Their adoption has not had any material impact on the disclosures or on the amounts reported in these financial statements.
Annual Report 2022 – 2023
63
Notes to the Consolidated Financial Statements (cont.)
New and revised Australian Accounting Standards and Interpretations on issue but not
yet effective
Certain new accounting standard and interpretations have been published that are not mandatory for June 30, 2023 reporting
periods and have not been early adopted by the Company.
The new and revised Accounting Standards, Interpretations and amendments listed above are not expected to have a material
impact on the amounts recognized or disclosures included in the Group’s financial statements.
6. Segment information
The Group operates in one industry and two geographical areas, those being the biotechnology and healthcare industry and
Australia and US, respectively.
The Group is focused primarily on developing a novel therapy for the treatment of highly prevalent and progressive retinal diseases.
The Chief Executive Officer regularly reviews entity wide information that is compliant with Australian Accounting Standards.
There is only one segment for segment reporting purposes, and the information reviewed by the Chief Executive Officer for
the purpose of resources allocation and performance assessment is the same as the information presented in the consolidated
financial statements.
The Group’s only revenue stream in the current and prior financial years is royalty income generated from licenses granted in
respect of the Group’s intellectual property that are unrelated to the Group’s core business and the development of Sozinibercept
OPT‑302 and that are not under development. These licenses are primarily used by third‑party licensees for research purposes.
All of the royalty income of $108,406 (2022: $90,683) was generated from customers based outside of Australia. The Group
does not have any major customers. All equipment is located in Australia and United States.
7. Revenue
2023
US$
2022
US$
Sales‑based royalties
108,406
90,683
Total revenue
108,406
90,683
8. Other income
2023
US$
2022
US$
Grant and other income
276,869
108,322
Total other income
276,869
108,322
9. Research and development expenses
2023
US$
2022
US$
Research project costs1
122,128,314
78,654,217
Total research and development expenses
122,128,314
78,654,217
1.
The research project costs relate to the research programs in respect to the treatment of eye diseases by OPT‑302.
64
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
10. Expenses
2023
US$
2022
US$
Administrative expenses
Employee expenses:
Salaries and fees
6,274,560
2,931,243
Cash bonuses
1,265,944
376,649
Superannuation
287,396
171,899
Share‑based payments expense
5,834,686
5,251,572
Total employee benefits expense
13,662,586
8,731,363
Other expenses:
Insurance
2,551,768
4,205,106
Investor relations costs
451,378
328,026
Audit and accounting
337,038
496,652
Travel expenses
580,644
13,616
Payroll tax
340,003
172,884
Legal fees
1,330,054
1,252,014
Advisory fees1
6,084,005
156,978
Consultancy costs
1,389,048
1,619,824
Other expenses
1,288,179
867,405
Total other expenses
14,352,117
9,112,505
Depreciation of:
Equipment and furniture
17,000
11,917
Right‑of‑use asset
84,226
66,465
Total depreciation expense
101,226
78,382
Loss on disposal of non‑current assets
–
169
Total administrative expenses
28,115,929
17,922,419
1.
Advisory fees relates to a market assessment of potential financing alternatives and solutions.
Annual Report 2022 – 2023
65
Notes to the Consolidated Financial Statements (cont.)
11. Finance income
2023
US$
2022
US$
Interest income
3,227,496
235,468
3,227,496
235,468
12. Interest expense on DFA
2023
US$
2022
US$
Interest expense on DFA
13,462,160
–
13,462,160
–
The interest expense on DFA is non-cash interest at the imputed rate of 23.82%.
13. Fair value adjustment gain on DFA
2023
US$
2022
US$
Fair value adjustment gain on DFA
12,302,160
–
12,302,160
–
There are several factors that could affect the estimated timing of regulatory approval and attainment of sales milestones, some
of which are not entirely within the Group’s control. Therefore, at each reporting date, the Group reassesses the estimated timing
of regulatory approval and attainment of sales milestones and the expected fixed and variable contractual success fee payments
due therefrom. If the timing and/or amount of such expected payments is materially different from the estimates used on the
initial recognition date, the Group will adjust the accretion of the development financing liability using the previously determined
imputed interest rate.
At June 30, 2023 the Group performed a fair value adjustment of the carrying amount of the Financial Liability. The expected
timeline for approval and commercial launch have been delayed by twelve months, thus extending date of expected repayments.
As the Group has more time to repay the amounts owed, the carrying value of the Financial Liability at June 30, 2023 was
adjusted downward to reflect this delay. The fair value adjustment resulted in a non-cash gain on revaluation of $12.3 million.
This change is recorded on the Profit or Loss statement as an unrealized fair value adjustment gain on the DFA. The Group will
continue to accrete non-cash interest at the imputed rate of 23.82%. Refer to Note 25.
At every reporting period, the Group will review the expected approval and commercial launch dates. If the dates are delayed
from those used at June 30, 2023, it is expected that a fair value adjustment will result in another non-cash gain. If the timelines
for approval and launch are accelerated, the Group would anticipate a fair value adjustment resulting in a non-cash charge to be
recognized on the Profit or Loss statement.
66
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
14. Net foreign exchange loss
2023
US$
2022
US$
Net foreign exchange losses
(489,137)
(2,813,993)
(489,137)
(2,813,993)
Exchange differences arising on the translation of monetary items are recognized in the Statement of Profit or Loss and other
Comprehensive Income.
15. Income tax
2023
US$
2022
US$
(a) Income tax benefit
The major components of income tax benefit are:
Statement of Profit or Loss and Other Comprehensive Income
Current tax
Current income tax credit
5,926,350
6,299,286
5,926,350
6,299,286
Deferred tax
In respect of the current year
–
–
Total income tax benefit recognized in the Statement of Profit or Loss
and Other Comprehensive Income
5,926,350
6,299,286
(b) Current tax receivable
Research and Development Tax Incentive Credit receivable
5,926,350
6,299,286
Annual Report 2022 – 2023
67
Notes to the Consolidated Financial Statements (cont.)
(c) Numerical reconciliation between aggregate income tax benefit recognized in the Statement of Profit or Loss
and Other Comprehensive Income and benefit calculated per the statutory income tax rate.
A reconciliation between income tax benefit and the product of accounting loss before income tax multiplied by the Group’s
applicable income tax rate is as follows:
2023
US$
2022
US$
Accounting loss before tax
(148,447,435)
(99,116,657)
At the Company’s statutory income tax rate of 30% (2022: 30%)
44,534,230
29,734,997
R&D tax incentive on eligible expenses
5,926,350
6,299,286
Non‑deductible R&D expenditure
(4,087,138)
(4,344,335)
Other non‑deductible expenses – share‑based payment expense
(1,750,406)
(1,575,472)
Amount of temporary differences and carried forward tax losses not recognized
(38,696,687)
(23,815,190)
Income tax benefit reported in the Statement of Profit or Loss and
Other Comprehensive Income
5,926,350
6,299,286
(d) Recognized deferred tax assets and liabilities
in statement of financial position
Deferred income tax at June 30 relates to the following:
Deferred tax liabilities:
Interest and royalty income receivable (future assessable income)
(44,785)
(17,085)
(44,785)
(17,085)
Deferred tax assets related to temporary differences:
Recognition of tax losses
–
–
Accrued expenses and other liabilities
200,536
198,607
Employee provisions
161,006
161,159
Other miscellaneous items
270,721
306,531
632,263
666,297
Net deferred tax assets
587,478
649,212
Less: temporary differences not recognized
(587,478)
(649,212)
Net deferred tax recognized in the statement of financial position
–
–
(e) Unrecognized temporary differences
Temporary differences with respect to deferred tax assets associated with intellectual property and other miscellaneous items
which have a low probability of realization are unrecognized. These amounted to $nil at year end (2022: $nil).
68
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
(f) Carry forward unrecognized tax losses
The Group had income tax losses of $67,878,759 and capital losses of $412,122 at year end (2022: income tax losses of
$37,717,792 and capital losses of $412,122) for which no deferred tax asset is recognized on the statement of financial position
as they are currently not considered probable of realization. These tax losses are available indefinitely for offset against future
assessable income subject to continuing to meet relevant statutory tests.
(g) Franking credit balance
Franking credits are a type of tax credit in Australia that is available to the Group’s shareholder to reduce double taxation on any
dividends paid by the Group. The franking account balance at the end of the financial year at 30% is A$227,371 (2022: A$227,371),
which represents the amount of franking credits available for the subsequent financial year.
Franking credits are not recognized in the consolidated statement of financial position.
16. Earnings per share
2023
US$
2022
US$
The following reflects the income used in the basic and diluted earnings per
share computations:
(a) Earnings used in calculating earnings per share
Net loss attributable to ordinary equity holders of the parent
(142,521,085)
(92,817,371)
(b) Weighted average number of shares
Weighted average number of ordinary shares on issue for basic earnings per share
442,637,406
351,560,199
Effect of dilution:
Share options
–
–
Weighted average number of ordinary shares adjusted for the effect of dilution
442,637,406
351,560,199
Loss per share (basic and diluted in cents)
(32.20)
(26.40)
On August 24 and 28, 2023 the Company announced a capital raising which will involved 195,647,457 ordinary shares and options
that represent potential ordinary shares of 97,823,728 that would significantly change the number of ordinary shares or potential
ordinary shares outstanding between the reporting date and the date of completion of this financial report. There is no impact
on the current basic an diluted earnings per share.
Diluted earnings per share is calculated as net loss divided by the weighted average number of ordinary shares and dilutive potential
ordinary shares. Options granted under the Long-Term Incentive (LTIP) and Non‑Executive Director Share and Option (NED Plan)
plans would generally be included in the calculation due to the conditions of the issuance being satisfied. As the Group is in a loss
position, the options are anti‑dilutive and, accordingly, the basic loss per share is the same as the diluted loss per share.
Annual Report 2022 – 2023
69
Notes to the Consolidated Financial Statements (cont.)
A total number of 25,450,000 options/rights outstanding at June 30, 2023 (2022: 22,988,000) and 1,505,000 ADS options
that represent 8 ordinary shares for each ADS held (2022: 925,000) were anti‑dilutive and were therefore excluded from the
weighted average number of ordinary shares for the purpose of diluted earnings per share. As the Group is in a loss position,
the options are anti‑dilutive and, accordingly, the basic loss per share is the same as the diluted loss per share. These options
related to the following option plans:
2023
No.
2022
No.
NED Plan
16,500,000
14,000,000
LTIP
6,050,000
7,388,000
22,550,000
21,388,000
Performance Rights
These rights related to the following option plans:
2023
No.
2022
No.
NED Plan
650,000
–
LTIP
2,250,000
1,600,000
2,900,000
1,600,000
ADS options
These rights related to the following option plans:
2023
No.
2022
No.
NED Plan
–
–
LTIP
1,505,000
925,000
1,505,000
925,000
As at June 30, 2023, 10,842,234 outstanding options and rights were exercisable as of that date (2022: 12,857,589).
As at June 30, 2023, 250,000 (2022: $nil) outstanding ADS options were exercisable as of that date.
70
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
17. Current assets – cash and cash equivalents
2023
US$
2022
US$
Cash at bank and in hand
12,067,158
11,853,883
Short‑term deposits
77,121,555
32,777,410
Total cash and cash equivalents
89,188,713
44,631,293
Cash at bank earns interest at floating rates based on daily bank deposit rates. The carrying amounts of cash and cash
equivalents represent fair value.
Short‑term deposits are with two major Australian banks and are made for varying periods of between 30 and 90 days,
depending on the immediate cash requirements of the Group, and earn interest at a fixed rate for the respective short‑term
deposit periods. At year end, the average rate was 4.67% (2022: 0.43%).
18. Current assets – receivables
2023
US$
2022
US$
Interest receivable
162,853
56,952
GST receivable
325,474
157,060
Other receivable
148,237
43,656
Total current receivables
636,564
257,668
The GST and other receivables are non‑interest bearing. There were no receivables with a material expected credit loss recorded
during the financial year (2022: $nil).
19. Current assets – prepayments
2023
US$
2022
US$
R&D Contract Research Organization
1,693,964
7,428,599
Insurance
717,064
1,086,847
Other prepayments
223,643
204,749
Total current prepayments
2,634,671
8,720,195
The R&D Contract Research Organization prepayment consists of prepayments on the Phase 3 clinical trial for OPT‑302
in order to secure sites across the world and start patient recruitment. These prepayments covered the initial start-up of the
Phase 3 clinical trials and other key milestones and are expected to be consumed within the next 12 months. The insurance
amount relates to specific Phase 3 Clinical trial insurance in place for various sites around the world covering periods to 2024.
The non‑current portion of the prepayments are recorded as non‑current assets. Refer to Note 21.
Annual Report 2022 – 2023
71
Notes to the Consolidated Financial Statements (cont.)
20. Non‑current assets – right-of-use assets
The Group has a three-year lease contract for its head office premises in Melbourne, Australia which commenced on July 15, 2022.
The agreement does not contain any extension options. The carrying amount of the lease at June 30, 2023 is as follows:
2023
US$
2022
US$
Right-of-use asset cost
Opening balance as at July 1
281,554
281,554
Additions
252,677
–
534,231
281,554
Right-of-use asset depreciation
Opening balance as at July 1
(281,554)
(187,702)
Charge to the period
(84,226)
(93,852)
(365,780)
(281,554)
Net carrying amount at June 30
168,451
–
21. Non‑current assets – prepayments
2023
US$
2022
US$
Insurance
53,535
110,295
Total non‑current prepayments
53,535
110,295
The non‑current prepayment amount relates to specific Phase 3 Clinical trial insurance in place for various sites around the world
covering periods to 2024.
22. Current liabilities – payables
2023
US$
2022
US$
Creditors (unsecured)
17,842,981
11,402,164
Payroll related tax liability
48,873
43,334
Total current payables
17,891,854
11,445,498
Creditors are non‑interest bearing and are normally settled on 30 day terms.
23. Current liabilities – provisions
2023
US$
2022
US$
Annual leave
500,361
383,220
Long service leave
252,939
212,983
Total current provisions
753,300
596,203
72
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
24. Non‑current liabilities – Lease Liabilities
Lease liabilities are as indicated below.
At the commencement date of the lease of its office premises, the Group recognizes lease liabilities measured at the present
value of lease payments to be made over the lease term ending July 14, 2024, using an incremental borrowing rate of 3%.
2023
US$
2022
US$
Carrying amount at July 1
–
112,965
New lease
252,677
–
Payments
(70,966)
(112,965)
Carrying amount at June 30
181,711
–
Maturity analysis:
Year 1
102,806
–
Year 2
84,226
–
187,032
–
Less: unearned interest
(5,321)
–
181,711
–
Analyzed into:
Current portion
97,485
–
Non‑current portion
84,226
–
181,711
–
2023
US$
2022
US$
Amounts recognized in profit or loss:
Depreciation expense of right-of-use asset
84,226
66,465
Lease finance costs
5,321
5,920
Expense relation to leases of low value assets
2,101
7,376
91,648
79,761
Annual Report 2022 – 2023
73
Notes to the Consolidated Financial Statements (cont.)
25. Non‑current liabilities – financial liabilities
2023
US$
2022
US$
Carrying amount at July 1
–
–
Funding at fair value
84,500,000
–
Interest expense on DFA
13,462,160
–
Fair value gain on DFA
(12,302,160)
–
Total financial liabilities
85,660,000
–
Pursuant to the DFA, Launch Tx has committed to provide Opthea US$120 million in funding which may be increased up to
US$170 million at their option, of which US$50 million (net of US$0.5 million of funding costs) was paid in September 2022.
Opthea received the proceeds from the first two tranches of the DFA, with the remainder being funded in a third tranche, to be
paid on or before December 31, 2023. Pursuant to the DFA, Opthea is required to use commercially reasonable efforts to develop
Sozinibercept for the treatment of wet AMD in accordance with the DFA, including pursuant to certain development timelines set
forth therein. The DFA contains terms that require compliance by the Company to maintain a minimum cash balance and to provide
a notice to Ocelot in the event it anticipates that it does not have sufficient cash to fund its operations for the next six months.
In return, Opthea will pay to Launch Tx (1) upon the first to occur of regulatory approval of Sozinibercept (OPT‑302) for the
treatment of wet AMD in the United States, United Kingdom or European Union (“Regulatory Approval”), fixed payments equal
to a total of approximately two times the funding provided, consisting of seven payments, with the first payment due shortly
after Regulatory Approval and the remaining six annual payments payable over a six‑year period thereafter, and (2) variable
payments equal to 7% of net sales of sozinibercept for the treatment of wet AMD for each calendar quarter. The fixed and
variable payment obligation discharge once Launch Tx has received a total of four times their investment.
In certain instances which may result upon the termination of the Funding Agreement, we will be obligated to pay Investor
several multiples of the amounts paid to us under the Funding Agreement. The Group remains in compliance with the DFA
and no such instances has occurred.
The Group evaluated the Financing Agreement and determined it to be a research and development funding arrangement with
the characteristics of a debt instrument, as the transfer of financial risk to Launch Tx was not considered substantive and
genuine. Accordingly, the Company has recorded payments received under the Financing Agreement as part of a development
financing liability in its consolidated balance sheets. The Group accounts for the overall development financing liability at
amortized cost based on the estimated timing of regulatory approval and attainment of certain sales milestones and the contractual
success fee payments expected to be due therefrom, as discounted using an imputed interest rate. The development financing
liability will be accreted as interest expense to its expected future repayment amount over the expected life of the agreement
using the effective interest rate method. Certain legal and financial advisory fees incurred specifically to complete the Financing
Agreement were capitalized and recorded as a reduction to the carrying amount of the development financing liability and will
also be amortized to interest expense using the effective interest method.
Pursuant to the Financing Agreement, Opthea granted Launch Tx a security interest in all its assets (other than intellectual property
not related to Sozinibercept (OPT‑302)), provided that the Group is permitted to incur certain indebtedness. The security interest
will terminate when the Group has paid Launch Tx of the funding provided or upon certain terminations of the Financing Agreement.
There are several factors that could affect the estimated timing of regulatory approval and attainment of sales milestones, some
of which are not entirely within the Group’s control. Therefore, at each reporting date, the Group reassesses the estimated timing
of regulatory approval and attainment of sales milestones and the expected contractual success fee payments due therefrom.
If the timing and/or amount of such expected payments is materially different than original estimates, the Group will prospectively
adjust the accretion of the development financing liability and the imputed interest rate. Refer to Note 13.
As of June 30, 2023, the development financing liability was classified as a long‑term liability, as the Group expects the related
repayments to take place between 2027 and 2032 for purposes of the model used to calculate its carrying value. The imputed
interest rate on the unamortized portion of the development financing liability was approximately 23.82%.
74
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
26. Non‑current liabilities – provisions
2023
US$
2022
US$
Long service leave
7,631
27,974
7,631
27,974
27. Contributed Equity
2023
US$
2022
US$
(a) Ordinary shares
Issued and fully paid at June 30
320,883,551
235,277,217
Movement in ordinary shares:
Opening balance
235,277,217
234,147,526
Issue of shares on exercise of options granted under the LTIP
3,790,978
1,129,691
Issue of shares net of issuance cost $
81,815,357
–
320,883,552
235,277,217
Ordinary shares on issue:
No:
No:
Opening balance
352,152,542
351,003,541
Issue of shares on exercise of options granted under the LTIP
2,387,826
1,149,001
Issue of shares
112,619,066
–
467,159,434
352,152,542
Fully paid ordinary shares carry one vote per share and carry the right to dividends. No cash dividends have been paid, declared,
or recommended during or since the end of the financial year by the Company. Issued capital at June 30, 2023 amounted to
$320,883,552 (467,159,434 fully paid ordinary shares) net of share issue costs and tax. During the year ended June 30, 2023
the Company issued 112,619,066 ordinary shares for net proceeds of $81,815,357 via a placement in August/September 2022.
At June 30, 2023, the Company had 7,250,000 Non‑Executive Director options that remain unexercised with expiry
of October 2024 for 3,000,000 options, January 2025 for 2,250,000 options, October 2025 for 1,000,000 options
and April 2026 for 1,000,000 options.
At June 30, 2022, the Company had 7,500,000 Non‑Executive Director options that remain unexercised with expiry of
November 2022 for 3,000,000, October 2024 for 2,000,000 options, January 2025 for 1,500,000 options, October 2025
for 500,000 options and April 2026 for 500,000 options.
(b) Options granted to directors and employees
The Company has two share‑based payment schemes, the Long-Term Incentive Plan (LTIP) and Non‑Executive Director Share
and Option Plan. Options to subscribe for the Company’s shares have been granted under these plans to certain employees
and directors.
The Company granted 10,050,000 options/rights over ordinary shares and 755,000 ADS options under these plans during the
year ended June 30, 2023 (Note 35). These options/rights had a weighted average fair value at grant date of $1.62 per option.
During the year ended June 30, 2023, 6,613,000 options granted under the LTIP and NED Plan were exercised for $3,790,977
($1,040,718 for cash and $2,750,258 via cashless conversion) with 2,387,826 ordinary shares issued.
Annual Report 2022 – 2023
75
Notes to the Consolidated Financial Statements (cont.)
The Company granted 8,400,000 options/rights over ordinary shares and 925,000 ADS options under these plans during the
year ended June 30, 2022 (Note 35). These options/rights had a weighted average fair value at grant date of $0.781 per option.
During the year ended June 30, 2022, 2,056,000 options granted under the LTIP and NED Plan were exercised for $1,129,691
($257,175 for cash and $872,516 via cashless conversion) with 1,149,001 ordinary shares issued.
(c) Capital management
The Group is not subject to any externally imposed capital requirements. When managing share capital, management’s objective
is to ensure the entity continues as a going concern as well as to provide benefits to shareholders and for other stakeholders.
In order to maintain or achieve an appropriate capital structure, the Company may issue new shares or reduce its share capital,
subject to the provisions of the Company’s constitution. The Group only commits to significant R&D expenditure when this is
fully funded either by existing funds or further equity raises.
28. Accumulated losses and reserves
2023
US$
2022
US$
(a) Movements in accumulated losses were as follows:
Balance at July 1
(216,941,353)
(124,123,982)
Net loss for the period
(142,571,085)
(92,817,371)
Balance at June 30
(359,462,438)
(216,941,353)
(b) Reserves
Fair value of investments reserve (i)
1,085,411
1,085,411
Share‑based payments reserve (ii)
11,551,134
8,466,706
Foreign translation reserve (iii)
20,089,163
20,089,163
Total reserves
32,725,708
29,641,280
(i) Movement in fair value of investments reserve:
Opening balance
1,085,411
1,085,411
Closing balance
1,085,411
1,085,411
(ii) Movement in share‑based payments reserve:
Opening balance
8,466,706
4,087,650
Share‑based payments expense
5,834,686
5,251,572
Exercise of options
(2,750,258)
(872,516)
Closing balance
11,551,134
8,466,706
(iii) Movement in Foreign translation reserve:
Opening balance
20,089,163
20,089,163
Gain/loss on translation
–
–
Closing balance
20,089,163
20,089,163
76
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
(c) Nature and purpose of reserves
Fair value of investments reserve
This reserve records fair value changes on listed investments. As at June 30, 2023 no remaining investments are held by
the Group. Management’s accounting policy is to not reclassify the realized fair value to accumulated loss upon disposal.
Share‑based payment reserve
This reserve is used to record the value of equity benefits provided to executives and employees as part of their remuneration.
Foreign currency translation reserve
The reserve records the value of foreign currency movements on the initial translation of financial statements from A$ to US$
that was completed in prior year.
29. Financial risk management objectives and policies
The Group’s principal financial assets comprise cash, receivables and short‑term deposits.
The Group manages its exposure to key financial risks, including interest rate and currency risk in accordance with the Group’s
financial risk management practices. The objective is to support the delivery of the Group’s financial targets whilst protecting
future financial security.
The Group’s other various financial assets and liabilities, such as receivables and payables, arise directly from its operations.
The main risks arising from the Group’s financial assets and liabilities are interest rate risk, foreign currency risk and liquidity risk.
The Group uses different methods to measure and manage different types of risks to which it is exposed. These include monitoring
levels of exposure to interest rate and foreign exchange risk and assessments of market forecasts for interest rates and foreign
exchange rates. Liquidity risk is monitored through future rolling cash flow forecasts.
The board reviews and agrees policies for managing each of these risks as summarized below.
Risk exposures and responses
The Group has investigated the main financial risk areas which could impact on its financial assets and determined the impact
on post-tax (losses) or profits for a range of sensitivities. These can be seen in the post-tax (loss)/profit impact for each risk area.
For each risk area, the equity impact relates solely to reserve movements and excludes movements in accumulated losses as the
impact of these can be seen within the post-tax (loss)/profit impact.
(i) Interest rate risk
The Group’s exposure to market interest rates relates primarily to the short‑term deposits. The deposits are held with two of
Australia’s largest banks.
The objective of managing interest rate risk is to minimize the Group’s exposure to fluctuations in interest rates that might impact
its interest income and cash flow. To manage interest rate risk, the Group invests the majority of its cash in short‑term deposits
for varying periods of between 30 days and 90 days, depending on the short and long‑term cash requirements of the Group
which is determined based on the Group’s cash flow forecast. This consideration also takes into account the costs associated
with recalling a term deposit should early access to cash and cash equivalents be required. Cash is not locked into long‑term
deposits at fixed rates so as to mitigate the risk of earning interest below the current floating rate.
The Group currently has borrowings under the DFA with Ocelot. (2022: $nil). Refer to Note 25.
Annual Report 2022 – 2023
77
Notes to the Consolidated Financial Statements (cont.)
The following sensitivity analysis (an annual effect) is based on the interest rate risk exposures at June 30, 2023 and 2022.
At June 30, 2023, if interest rates moved, with all variables held constant, post-tax (loss)/profit and equity would have been
affected as illustrated in the following table:
Post-tax (loss)/profit impact
Judgments of reasonably possible movements
2023
US$
2022
US$
+ 0.50% (50 basis points) (2022: + 0.50%)
270,059
114,859
– 0.50% (50 basis points) (2022: – 0.50%)
(270,059)
(114,859)
The post-tax figures include an offset for unrecognized tax losses (bringing the tax effect to $nil) for the year ended
June 30, 2023 (2022: $nil).
Significant assumptions used in the interest rate sensitivity analysis include:
•
The reasonably possible movement of 0.5% was calculated by taking the interest rates as at balance date, moving these
by plus and minus 0.5% and then re‑calculating the interest on term deposits with the ‘new‑interest‑rate’.
•
The net exposure at balance date is representative of what the Group was and is expecting to be exposed to in the next
twelve months from balance date.
(ii) Foreign currency risk
As a result of services provided by non‑related entities in Australia, Canada, United Kingdom and Europe, part of the Group’s
monetary assets and liabilities are affected by movements in the exchange rate.
The Group does not enter into any hedging transactions.
At the reporting date, the Group has the following exposure to foreign currencies.
Consolidated
2023
AUD2023
US$
EURO2023
US$
GBP2023
US$
CAD2023
US$
Financial assets
Cash
55,307,319
–
–
–
Receivables
6,290,086
–
–
–
Financial liabilities
Payables
(1,187,459)
(53,332)
(3,166)
(136,689)
Other financial liabilities
–
–
–
–
Net exposure
60,409,946
(53,332)
(3,166)
(136,689)
2022
AUD2022
US$
EURO2022
US$
GBP2022
US$
CAD2022
US$
Financial assets
Cash
26,697,582
–
–
–
Receivables
7,827,565
–
–
–
Financial liabilities
Payables
(1,213,469)
(435,698)
(3,037)
(13,419)
Other financial liabilities
–
–
–
–
Net exposure
33,311,678
(435,698)
(3,037)
(13,419)
78
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
The following sensitivity is based on the foreign currency risk exposures in existence at June 30, 2023 and 2022.
At June 30, 2023 and 2022, had the United States dollar moved with all other variables held constant, post-tax (loss) profit
and equity would have been affected as illustrated in the table below:
Post-tax (loss)/profit impact
Judgments of reasonably possible movements
2023
US$
2022
US$
Consolidated
AUD/USD +10% (2022: +10%)
(3,847,285)
(2,119,834)
AUD/USD –10% (2022: –10%)
4,702,237
2,590,908
The reasonably possible movements at June 30, 2023 are higher than at June 30, 2022 due mainly to the net exposure to the
Australian dollar due to cash at bank deposits. There was minimum or insignificant exposure to the GBP, Euro and CAD during
the current financial year.
Significant assumptions used in the foreign currency exposure sensitivity analysis include:
•
The reasonably possible movement of 10% was calculated by taking the currency spot rates as at balance date, moving these
by 10% and then re‑converting the currencies into US with the ‘new‑spot‑rate’. This methodology reflects the translation
methodology undertaken by the Group.
•
The net exposure at balance date is representative of what the Group was and is expecting to be exposed to in the next
twelve months from balance date.
Management believes the balance date risk exposures are representative of the risk exposure inherent in the financial instruments.
(iii) Credit risk
Credit risk is associated with those financial assets of the Group which comprise cash and cash equivalents and receivables.
The Group’s exposure to credit risk arises from default of the counter party, with a maximum exposure equal to the carrying
amount of these investments. Credit risk is considered minimal as the Group transacts with reputable recognized
Australian banks.
(iv) Liquidity risk
Liquidity risk arises from the financial liabilities of the Group and the Group’s subsequent ability to meet their obligations to
repay their financial liabilities as and when they fall due. The Group manages liquidity risk by maintaining adequate reserves and
by monitoring forecast and actual cash flows and by matching the maturity profiles of financial assets and liabilities. The financial
liabilities of the Group relate to trade payables that are all expected to be paid within 12 months. With the funding agreement
that was entered on August 12, 2022 the Group may incur a total payment equal to approximately four times the funding
provided, consisting of seven payments, with the first payment due shortly after Regulatory Approval and the remaining six
payments payable over a six‑year period thereafter, and variable payments equal to 7% of net sales of Sozinibercept (OPT‑302)
for the treatment of wet AMD for each calendar quarter.
The Group’s objective is to maintain an appropriate cash asset balance to fund its operations.
Annual Report 2022 – 2023
79
Notes to the Consolidated Financial Statements (cont.)
30. Related party disclosures
(a) Subsidiaries
Parent equity % equity interest
Name of company
2023%
2022%
Vegenics Pty Ltd1
100
100
Opthea US Inc2
100
100
1.
Opthea Limited is the ultimate parent entity. Vegenics Pty Ltd is incorporated in Australia and has the same financial year as Opthea Limited.
2. Opthea Limited is the ultimate parent entity. Opthea US was incorporated in the United States in May 2021 and has the same financial year
as Opthea Limited.
(b) Transactions with related parties
Balances and transactions between the Company and its subsidiaries, which are related parties have been eliminated on
consolidation and are not disclosed in this note. Transactions between the Group and its associates are disclosed below:
•
With the appointment of Anshul Thakral (who is the CEO of Launch and Operation Executive of Carlyle) on June 7, 2023,
as a Director of Opthea, resulting in Launch, Ocelot and Carlyle being related parties of Opthea.
Trading transactions
During the year, group entities entered into the following transactions with related parties who are not members of the Group.
Consolidated
Purchase of Services
2023
2022
Launch Tx – Ocelot
–
–
Launch
900,000
–
Purchase of services assisting Opthea with the management and oversight of trials under the Service Agreement with Launch Tx.
Consolidated
Amounts owed to
related parties
2023
2022
Launch Tx – Ocelot
85,660,000
–
Launch
–
–
Amounts owed to Ocelot relate to the Development Funding agreement and carry an effective interest rate of 23.82% (refer to
Note 25).
80
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
31. Cash flow statement reconciliation
(a) Reconciliation to cash at the end of the year
2023
US$
2022
US$
Cash at bank and in hand (Note 17)
89,188,713
44,631,293
89,188,713
44,631,293
(b) Reconciliation of net loss after tax to net cash flows from operations
Net loss for the year
(142,521,085)
(92,817,371)
Adjustments for:
Income tax benefit recognized in profit or loss
(5,926,350)
(6,299,286)
Net loss on disposal of non‑current assets
–
169
Depreciation of non‑current assets
17,001
11,917
Depreciation of right‑of‑use asset
84,226
66,465
Share‑based payments expense
5,834,685
5,251,572
Interest expense on DFA
13,462,160
–
Fair value gain on DFA
(12,302,160)
–
Net foreign exchange differences
489,137
2,813,993
1,658,699
1,844,830
Changes in working capital:
Payables
7,296,785
8,511,607
Receivables
378,896
307,618
Prepayments
6,142,284
5,730,207
Provisions
136,755
115,259
Net cash flows used in operating activities before tax
(126,907,665)
(76,307,850)
R&D tax incentive received
6,299,286
4,972,898
Net cash flows used in operating activities
(120,608,379)
(71,334,952)
Annual Report 2022 – 2023
81
Notes to the Consolidated Financial Statements (cont.)
32. Commitments
(i) Research projects and license commitments
The Group has entered into research and development contracts and intellectual property license agreements with various
third parties in respect of services for the Phase 3 wet AMD clinical trial and the clinical grade manufacture of OPT‑302.
Expenditure commitments relating to these, and intellectual property license agreements are payable as follows:
2023
US$
2022
US$
Within one year
12,632,801
39,947,900
After one year but not more than five years
12,302,260
8,007,202
After more than five years
30,000
45,000
24,965,061
48,000,102
Currently, the biggest Research contract has a 60 day termination clause and all commitments have been limited to a six
month commitment.
(ii) Commercial commitments
The Group has entered into commercial agreements with various third parties in respect of services for preparation of OPT‑302
for launch and pre‑marketing phase. Expenditure commitments relating to these activities are payable as follows:
2023
US$
2022
US$
Within one year
47,415
507,874
After one year but not more than five years
–
–
After more than five years
–
–
47,415
507,874
Currently, the biggest contract has a 60 day termination clause and all commitments have been limited to a twelve
month commitment.
33. Contingencies
The Group is party to various research agreements with respect to which a commitment to pay is contingent on the achievement
of research milestones. Assuming all milestones are achieved within the time‑frames stipulated in the contracts, those which
could become payable in less than one year total $nil (2022: $nil) and those which could become payable in more than one year
total $1,086,244 (2022: $11,512,675).
Under these license/collaboration agreements, payments are to be made only if certain research and clinical development
milestones are achieved and royalties may become payable on any eventual sales of products developed under
these agreements.
The Group had a bank guarantee outstanding at June 30, 2023 in respect of a rental deposit for its office premises of $38,036
(2022: $39,478).
82
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
34. Key management personnel
(a) Compensation of Key Management Personnel
2023
US$
2022
US$
Short‑term employee benefits
2,898,544
1,555,658
Post‑employment benefits
137,168
56,105
Share‑based payments expense
4,221,472
4,664,767
Total compensation
7,257,184
6,276,530
Details of the key management personnel are included within the Remuneration Report section of the Directors’ Report.
(b) Other transactions and balances with director and key management personnel
and their related parties
There were no director and key management personnel related party transactions during the current or prior financial year other
than those disclosed in Note 30.
35. Share‑based payments
(a) Recognized share‑based payment expenses
The expense recognized for share‑based payments during the year is shown in the table below:
2023
US$
2022
US$
Expense arising from equity‑settled share‑based payment transactions:
Director and employee services received
5,834,686
5,251,572
(b) Non‑executive director and employee share option plans
During the 2015 financial year, the Group introduced an ownership‑based compensation scheme for non‑executive directors,
executives and senior employees, the Long-Term Incentive Plan (LTIP) and Non‑Executive Directors Share and Option Plan
(NED Plan). In accordance with the terms of the plans, as approved by shareholders at the 2014 annual general meeting, eligible
non‑executive directors, executives and senior employees with the Group may be granted options to purchase ordinary shares.
Each employee share option converts into one ordinary share of Opthea Limited on exercise. No amounts are paid or payable
by the recipient on receipt of the option. The options carry neither rights to dividends nor voting rights and are not transferable.
Options may be exercised at any time from the date of vesting to the date of their expiry.
The number of options granted is subject to approval by the board and rewards executives and senior employees to the extent of
the Group’s and the individual’s achievement judged against both qualitative and quantitative criteria as determined by the board
on a case by case basis.
Annual Report 2022 – 2023
83
Notes to the Consolidated Financial Statements (cont.)
The vesting condition of options granted under the LTIP and NED Plan is continuous service.
Options/Rights series
Grant date
Grant date
fair value
US$
Exercise
price
US$
Expiry date
Vesting date
LTIP – director FY2016
March 7, 2016
$0.14
$0.36
March 7, 2021
June 30, 2016
LTIP – director FY2019
November 29, 2018
$0.15
$0.625
November 29, 2022
November 29, 2019
LTIP – employee FY2016
March 31, 2016
$0.18
$0.37
January 1, 2022
January 1, 2017
LTIP – employee FY2018
August 23, 2017
$0.26
$0.92
January 1, 2023
June 30, 2018
LTIP – employee FY2019
April 3, 2019
$0.18
$0.608
April 3, 2023
April 3, 2021
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
October 19, 2021
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
October 19, 2022
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
October 19, 2023
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
January 31, 2023
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
November 30, 2022
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
April 30, 2023
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
April 30, 2023
LTIP – employee FY2022
October 19, 2021
$0.955
$0.00
October 18, 2031
September 30, 2024
LTIP – employee FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2021
LTIP – employee FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2022
LTIP – employee FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2023
LTIP – employee FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2024
LTIP – employee FY2022
June 6, 2022
$0.553
$1.46
June 5, 2032
June 6, 2022
LTIP – employee FY2022
June 6, 2022
$0.553
$1.46
June 5, 2032
June 6, 2023
LTIP – employee FY2022
June 6, 2022
$0.553
$1.46
June 5, 2032
June 6, 2024
LTIP – employee FY2022
June 6, 2022
$0.553
$1.46
June 5, 2032
June 6, 2025
LTIP – employee FY2023
November 16, 2022
$0.471
$0.658
November 16, 2032
November 16, 2025
LTIP – employee FY2023
November 16, 2022
$0.672
$0.00
November 16, 2032
November 16, 2025
LTIP – employee FY2023
December 13, 2022
$0459
$0.644
December 13, 2023
December 13, 2033
LTIP – employee FY2023
December 13, 2022
$0.459
$0.644
December 13, 2024
December 13, 2033
LTIP – employee FY2023
December 13, 2022
$0459
$0.644
December 13, 2025
December 13, 2033
LTIP – employee FY2023
December13, 2022
$0459
$0.644
December 13, 2026
December 13, 2033
NED Plan FY2016
March 7, 2016
$0.14
$0.36
March 7, 2021
June 30, 2016
NED Plan FY2019
November 29, 2018
$0.15
$0.625
November 29, 2022
November 29, 2019
NED Plan FY2021
October 12, 2020
$1.05
$3.24
October 11, 2024
October 11, 2020
NED Plan FY2021
October 12, 2020
$1.05
$3.24
October 11, 2024
October 11, 2021
NED Plan FY2021
October 12, 2020
$1.05
$3.24
October 11, 2024
October 11, 2022
NED Plan FY2021
October 12, 2020
$1.05
$3.24
October 11, 2024
October 11, 2023
NED Plan FY2021
October 12, 2020
$1.24
$2.16
October 11, 2024
October 11, 2021
NED Plan FY2021
October 12, 2020
$1.24
$2.16
October 11, 2024
October 11, 2022
84
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
Options/Rights series
Grant date
Grant date
fair value
US$
Exercise
price
US$
Expiry date
Vesting date
NED Plan FY2021
October 12, 2020
$1.24
$2.16
October 11, 2024
October 11, 2023
NED Plan FY2021
October 12, 2020
$1.24
$2.16
October 11, 2024
October 11, 2024
NED Plan FY2021
January 19, 2021
$0.88
$1.56
January 18, 2025
January 19, 2021
NED Plan FY2021
January 19, 2021
$0.88
$1.56
January 18, 2025
January 19, 2022
NED Plan FY2021
January 19, 2021
$0.88
$1.56
January 18, 2025
January 19, 2023
NED Plan FY2021
January 19, 2021
$0.88
$1.56
January 18, 2025
January 19, 2024
NED Plan FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2021
NED Plan FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2022
NED Plan FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2023
NED Plan FY2022
October 19, 2021
$0.526
$0.948
October 18, 2025
October 19, 2024
NED Plan FY2022
April 21, 2022
$0.397
$0.755
April 20, 2026
April 21, 2022
NED Plan FY2022
April 21, 2022
$0.397
$0.755
April 20, 2026
April 21, 2023
NED Plan FY2022
April 21, 2022
$0.397
$0.755
April 20, 2026
April 21, 2024
NED Plan FY2022
April 21, 2022
$0.397
$0.755
April 20, 2026
April 21, 2025
NED Plan FY2023
November 16, 2022
$0.469
$0.672
November 16, 2032
November 16, 2025
NED Plan FY2023
November 16, 2022
$0.471
$0.658
November 16, 2032
November 16, 2025
NED Plan FY2023
November 16, 2022
$0.672
$0.00
November 16, 2032
November 16, 2025
There has been no alteration of the terms and conditions of the above share‑based payment arrangements since the grant date.
(c) Fair value of share options granted
Where relevant, the expected life used in the model has been adjusted based on management’s best estimate for the effects
of non‑transferability, exercise restrictions (including the probability of meeting market conditions attached to the option), and
behavioral considerations. Expected volatility is based on the historical share price volatility over the past 4 or 5 years.
Grant date
share price
US$
Exercise
price
US$
Fair value
per option
US$
Expected
volatility
Option
life
Dividend
yield
Risk free
interest
rate
Model
used
LTIP – director FY2016
$0.28
$0.36
$0.14
65%
5 years
0%
2.09%
Binomial
LTIP – director FY2019
$0.42
$0.625
$0.15
58%
4 years
0%
2.04%
Binomial
LTIP – employee FY2016
$0.54
$0.37
$0.18
65%
5 years
0%
2.09%
Binomial
LTIP – employee FY2018
$0.34
$0.92
$0.26
66%
5 years
0%
2.09%
Binomial
LTIP – employee FY2019
$0.48
$0.608
$0.18
57%
4 years
0%
2.04%
Binomial
LTIP – employee FY2022
$0.955
$0.948
$0.526
74.78%
4 years
0%
0.25%
Binomial
LTIP – employee FY2022
$0.955
$nil
$0.955
n/a
10 years
0%
n/a
n/a
LTIP – employee FY2022
$0.901
$1.46
$0.553
75%
6.5 years
0%
3.4%
Binomial
LTIP – employee FY2023
$0.672
n/a
$0.672
75%
10 years
0%
3.7%
Binomial
LTIP – employee FY2023
$0.672
$0.658
$0.471
75%
6.5 years
0%
3.6%
Binomial
Annual Report 2022 – 2023
85
Notes to the Consolidated Financial Statements (cont.)
Grant date
share price
US$
Exercise
price
US$
Fair value
per option
US$
Expected
volatility
Option
life
Dividend
yield
Risk free
interest
rate
Model
used
LTIP – employee FY2023
$0.643
$0.644
$0.459
75%
7 years
0%
3.3%
Binomial
NED Plan FY2016
$0.28
$0.36
$0.14
65%
5 years
0%
2.09%
Binomial
NED Plan FY2019
$0.42
$0.625
$0.15
58%
4 years
0%
2.04%
Binomial
NED Plan FY2021
$2.19
$2.16
$1.24
77.25%
4 years
0%
0.25%
Binomial
NED Plan FY2021
$2.19
$3.24
$1.05
77.25%
4 years
0%
0.25%
Binomial
NED Plan FY2021
$1.56
$1.56
$0.88
77.01%
4 years
0%
0.25%
Binomial
NED Plan FY2022
$0.955
$0.945
$0.526
74.78%
4 years
0%
0.25%
Binomial
NED Plan FY2022
$0.741
$0.755
$0.397
75%
3.5 years
0%
2.7%
Binomial
NED Plan FY2023
$0.672
$0.672
$0.469
75%
6.5 years
0%
3.6%
Binomial
NED Plan FY2023
$0.672
$0.658
$0.471
75%
6.5 years
0%
3.6%
Binomial
NED Plan FY2023
$0.672
n/a
$0.672
75%
10 years
0%
3.7%
Binomial
Fair value of American depository shares options granted
Where relevant, the expected life used in the model has been adjusted based on management’s best estimate for the effects
of non‑transferability, exercise restrictions (including the probability of meeting market conditions attached to the option),
and behavioral considerations. Expected volatility is based on the historical share price volatility.
Grant date
share price
US$
Exercise
price
US$
Fair value
per ADS
options
US$
Expected
volatility
ADS
options
life
Dividend
yield
Risk free
interest
rate
Model
used
LTIP – employee
$7.240
$7.625
$4.970
75%
7 years
0%
1.4%
Binomial
LTIP – employee
$7.500
$7.515
$5.228
75%
7 years
0%
1.7%
Binomial
LTIP – employee
$5.925
$6.009
$4.116
75%
7 years
0%
1.7%
Binomial
LTIP – employee
$5.915
$6.090
$4.171
75%
7 years
0%
2.9%
Binomial
LTIP – employee
$7.000
$7.116
$4.953
75%
7 years
0%
2.9%
Binomial
LTIP – employee
$7.309
$7.445
$5.175
75%
7 years
0%
3.0%
Binomial
LTIP – employee
$5.500
$5.522
$3.886
75%
7 years
0%
3.4%
Binomial
LTIP – employee
$6.600
$6.350
$4.718
75%
7 years
0%
2.9%
Binomial
LTIP – employee
$4.810
$4.850
$3.479
75%
7 years
0%
4.3%
Binomial
LTIP – employee
$4.850
$5.170
$3.457
75%
7 years
0%
4.1%
Binomial
LTIP – employee
$4.590
$4.929
$3.560
75%
7 years
0%
3.6%
Binomial
LTIP – employee
$5.450
$5.238
$3.935
75%
7 years
0%
3.5%
Binomial
LTIP – employee
$5.030
$5.151
$3.602
75%
7 years
0%
3.8%
Binomial
LTIP – employee
$3.360
$3.545
$2.384
75%
7 years
0%
3.6%
Binomial
86
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
(d) Movements in share options/rights during the year
The following reconciles the share options/rights outstanding at the beginning and end of the year:
June 30, 2023
June 30, 2022
Number of
options and
rights
Weighted
average
exercise price
US$
Number of
options and
rights
Weighted
average
exercise price
US$
Balance at beginning of year
22,988,000
1.16
16,644,000
1.28
Granted during the year:
To employees and directors under the LTIP and NED Plan
10,050,000
0.58
8,400,000
0.77
Exercised during the year
(6,613,000)
0.62
(2,056,000)
0.58
Expired during the year
(975,000)
0.61
–
–
Balance at end of year
25,450,000
1.04
22,988,000
1.16
Exercisable at end of year
10,842,234
1.48
12,857,589
0.97
The share options outstanding at the end of the year had a weighted average exercise price of $1.48 (2022: $1.16) and a weighted
average remaining contractual life of 555 days (2022: 567 days).
(e) Movements in ADS options during the year
The following reconciles the ADS options outstanding at the beginning and end of the year:
June 30, 2023
June 30, 2022
Number of
options and
rights
Weighted
average
exercise price
US$
Number of
options and
rights
Weighted
average
exercise price
US$
Balance at beginning of year
925,000
6.75
–
–
Granted during the year:
To employees and directors under the LTIP and NED Plan
755,000
5.07
925,000
6.75
Exercised during the year
–
–
–
–
Expired during the year
(175,000)
7.62
–
–
Balance at end of year
1,505,000
5.81
925,000
6.75
Exercisable at end of year
250,000
6.70
–
–
Annual Report 2022 – 2023
87
Notes to the Consolidated Financial Statements (cont.)
36. Auditor’s remuneration
The auditor of Opthea Limited is Deloitte Touche Tohmatsu.
2023
A$
2022
A$
Deloitte and related networks firms:
Audit or review of the financial report of the entity and any other entity
in the consolidated group
$357, 500
$295,000
Statutory assurance services required by legislation to be provided by the auditor
–
–
Other assurances and agreed‑upon procedures under other legislation or
contractual arrangements
–
171,171
$357,500
$466,171
37. Events after the balance sheet date
On August 24, 2023, Opthea announced a A$80 million capital raise consisting via a A$10 million private placement (“Placement”)
and a A$70 million Accelerated Non-Renounceable Entitlement Offer (“ANREO”). On August 28, 2023, Opthea announced
an increase in the private placement by a further A$10 million to increase the overall raise to A$90 million. The proceeds from
the Placement and Entitlement will be used to continue advancing the clinical development of OPT-302 for the treatment
of wet Age-related Macular Degeneration (wet AMD) including to progress the Company’s Phase 3 clinical trials and for
general corporate purposes.
The Equity Financing of A$90 million (approximately US$58 million) consists of two closings, of which the first closing of A$73 million
(US$47 million) consisting of a placement offering and an acceleration portion of an Accelerated Non-Renounceable Entitlement
Offer (“ANREO”) occurred on September 1, 2023. The second closing of A$17 million (US$11 million), representing the remaining
institutional and retail portion of the ANREO, has been underwritten, is subject to customary closing conditions and settlement.
The shares were issued and cash received on September 20, 2023.
Subsequent to June 30, 2023, the Group was notified that a new co-investor of Carlyle and Abingworth intends to participate
in a funding under the DFA of US$50 million to increase total DFA funding from US$120 million to US$170 million, which is
subject to the co-investor’s final due diligence and regulatory and tax approvals, appropriate documentation and compliance
with closing conditions. Upon completion of the final due diligence, receipt of regulatory and tax approvals, execution of the
appropriate documentation and satisfaction of the closing conditions, the Group expects to receive the additional US$50 million.
While the Group anticipates that the due diligence will be completed to the satisfaction of the co-investor, the necessary approvals
will be obtained, the appropriate documentation will be executed and that all closing conditions will be satisfied, there is no
assurance that the Group will ultimately receive the additional US$50 million. If the additional US$50 million is not received
by June 30, 2024, the Group will need to raise additional funds or reduce expenditures to continue as a going concern.
On August 28, 2023 Mr Lawrence Gozlan, a director of the Company, and the Company have entered into a Consultancy
Agreement of up to US$300,000 in respect of the provision of services associated with managing, overseeing and coordinating the
conduct and implementation of the Capital Raising. The consultancy agreement is effective for the financial year June 30, 2024.
In the opinion of the Directors, these duties are outside the scope of the ordinary duties of a Director.
Besides the above, there are no other matters or circumstances that have arisen since the end of the reporting period, which
significantly affected, or may significantly affect, the operations of the Group, the results of those operations, or the state of
affairs of the Group in future financial years.
88
Opthea Limited
Notes to the Consolidated Financial Statements (cont.)
38. Parent entity information
The accounting policies of the parent entity, which have been applied in determining the financial information shown below, are the
same as those applied in the consolidated financial statements. Refer to Note 3 for significant accounting policies relating to the Group.
(a) Financial position
2023
US$
2022
US$
Current assets
106,797,144
61,913,395
Non‑current assets
223,420
129,015
Total assets
107,020,564
62,042,410
Current liabilities
(17,801,129)
(11,417,465)
Non‑current liabilities
(85,751,856)
(27,974)
Total liabilities
(103,505,597)
(11,445,439)
Net assets
3,514,967
50,596,971
Issued capital
320,883,552
235,277,217
Accumulated losses
(350,198,011)
(214,377,855)
Employee equity benefits reserve
11,551,134
8,466,706
Fair value of investments reserve
1,085,411
1,085,411
Foreign currency translation reserve
20,145,492
20,145,492
Total shareholders’ equity
3,467,578
50,596,971
(b) Financial performance
Year ended
June 30, 2023
US$
Year ended
June 30, 2022
US$
Loss of the parent entity
(135,820,154)
(90,264,957)
Other comprehensive income
–
–
Total comprehensive loss of the parent entity
(135,820,154)
(90,264,957)
(c) Parent entity contractual commitments for acquisition of property, plant and equipment
The parent entity does not have any contractual commitments for the acquisition of property, plant and equipment for the
year ended June 30, 2023 (2022: $nil).
(d) Parent entity contingent liabilities
The Company is party to various research agreements with respect to which a commitment to pay is contingent on the
achievement of research milestones. Assuming all milestones are achieved within the time‑frames stipulated in the contracts,
those which could become payable in less than one‑year total US$nil (2022: $nil) and those which could become payable
in more than one year total $1,086,244 (2022: $11,512,675).
Under these license/collaboration agreements, payments are to be made only if certain research and clinical development
milestones are achieved and royalties may become payable on any eventual sales of products developed under these agreements.
The parent entity had a bank guarantee outstanding at June 30, 2023 in respect of a rental deposit for its office premises
of $38,036 (2022: $39,478).
Annual Report 2022 – 2023
89
Directors’ Declaration
for the year ended June 30, 2023
In accordance with a resolution of the directors of Opthea Limited, we state that:
1. In the opinion of the directors:
a. the financial report and the notes thereto are in accordance with the Corporations Act 2001, including:
i.
giving a true and fair view of the Group’s financial position as at June 30, 2023 and of its performance for
the year ended on that date; and
ii. complying with Australian Accounting Standards, Corporations Regulations 2001, and International Financial
Reporting Standards (IFRS) as disclosed in Note 2 of the financial statements; and
b. there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become
due and payable.
2. This declaration has been made after receiving the declarations required to be made to the directors in accordance
with section 295A of the Corporations Act 2001 for the financial year ended June 30, 2023.
Signed in accordance with a resolution of the directors made pursuant to S.295(5) of the Corporations Act 2001.
On behalf of the directors:
Megan Baldwin
Jeremy Levin
CEO & Managing Director
Chairman
Opthea Limited
Opthea Limited
Melbourne
September 28, 2023
90
Opthea Limited
A
Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited (“DTTL”), its global network of member firms, and their
related entities (collectively, the “Deloitte organisation”). DTTL (also referred to as “Deloitte Global”) and each of its member
firms and related entities are legally separate and independent entities, which cannot obligate or bind each other in respect of
third parties. DTTL and each DTTL member firm and related entity is liable only for its own acts and omissions, and not those
of each other. DTTL does not provide services to clients. Please see www.deloitte.com/about to learn more.
Member of Deloitte Asia Pacific Limited and the Deloitte organisation.
©2023 Deloitte Touche Tohmatsu
Deloitte Touche Tohmatsu
ABN 74 490 121 060
8 Parramatta Square
Level 37, 10 Darcy Street
Parramatta, NSW, 2150
Australia
Phone: +61 2 9840 7000
www.deloitte.com.au
28 September 2023
Dear Directors,
Auditor’s Independence Declaration to Opthea Limited
In accordance with section 307C of the Corporations Act 2001, I am pleased to provide the following
declaration of independence to the directors of Opthea Limited.
As lead audit partner for the audit of the financial report of Opthea Limited for the year ended 30 June 2023,
I declare that to the best of my knowledge and belief, there have been no contraventions of:
•
the auditor independence requirements of the Corporations Act 2001 in relation to the audit; and
•
any applicable code of professional conduct in relation to the audit.
Yours faithfully
DELOITTE TOUCHE TOHMATSU
Vincent Snijders
Partner
Chartered Accountants
Board of Directors
Opthea Limited
Suite 403, Level 4
650 Chapel Street
South Yarra VIC 3141
Auditor’s Independence Declaration
Annual Report 2022 – 2023
91
Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited (“DTTL”), its global network of member firms, and their related entities
(collectively, the “Deloitte organisation”). DTTL (also referred to as “Deloitte Global”) and each of its member firms and related entities are
legally separate and independent entities, which cannot obligate or bind each other in respect of third parties. DTTL and each DTTL member
firm and related entity is liable only for its own acts and omissions, and not those of each other. DTTL does not provide services to clients.
Please see www.deloitte.com/about to learn more.
Member of Deloitte Asia Pacific Limited and the Deloitte organisation.
©2023 Deloitte Touche Tohmatsu
Deloitte Touche Tohmatsu
ABN 74 490 121 060
8 Parramatta Square
Level 37, 10 Darcy Street
Parramatta, NSW, 2150
Australia
Phone: +61 2 9840 7000
www.deloitte.com.au
Independent Auditor’s Report
to the Members of Opthea Limited
Report on the Audit of the Financial Report
Opinion
We have audited the financial report of Opthea Limited (“Opthea” or the “Company”) and its subsidiaries (the
“Group”), which comprises the Consolidated Statement of Financial Position as at 30 June 2023, the Consolidated
Statement of Profit or Loss and other Comprehensive Income, the Consolidated Statement of Changes in Equity and
the Consolidated Statement of Cash Flows for the year then ended, notes to the financial statements including a
summary of significant accounting policies and the directors’ declaration.
In our opinion the accompanying financial report of the Group is in accordance with the Corporations Act 2001,
including:
(i)
giving a true and fair view of the Group’s financial position as at 30 June 2023 and of its financial performance
for the year then ended; and
(ii) complying with Australian Accounting Standards and the Corporations Regulations 2001.
Basis for Opinion
We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those
standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Report section of this
report. We are independent of the Group in accordance with the auditor independence requirements of the
Corporations Act 2001 and the ethical requirements of the Accounting Professional and Ethical Standards Board’s
APES 110 Code of Ethics for Professional Accountants (including Independence Standards) (the “Code”) that are
relevant to our audit of the financial report in Australia. We have also fulfilled our other ethical responsibilities in
accordance with the Code.
We confirm that the independence declaration required by the Corporations Act 2001, which has been given to the
directors of the Company, would be in the same terms if given to the directors as at the time of this auditor’s report.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Material Uncertainty related to Going Concern
We draw attention to Note 2 of the financial statements which indicates that the Group incurred a net loss of
$142.5 million, had a net cash outflow from operating activities of $120.6 million during the year ended June 30,
2023, and, as of that date, the Group had an equity deficit of $5.8 million.
As stated in Note 2, these events or conditions, along with other matters as set forth in Notes 2 and 37, indicate
that a material uncertainty exists that may cast significant doubt on the Group's ability to continue as a going
concern. Our opinion is not modified in respect of this matter.
Independent Auditor’s Report
92
Opthea Limited
Independent Auditor’s Report (cont.)
Key Audit Matters
Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of
the financial report for the current period. These matters were addressed in the context of our audit of the
financial report as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on
these matters. In addition to the matter described in the Material Uncertainty related to Going Concern section,
we have determined the matters described below to be the key audit matters to be communicated in our report.
Key Audit Matter
How the scope of our audit responded to the Key Audit
Matter
Development Funding Agreement
On August 12, 2022, Opthea Limited entered into a
Development Funding Agreement ("DFA”) with
Ocelot SPV LP (the “Investor”), an affiliate of Carlyle
and Abingworth, working together with Carlyle and
Abingworth’s
recently
formed
development
company Launch Therapeutics, pursuant to which
the Investor agrees to provide funding to Opthea to
support its development of OPT-302 for the
treatment of wet (neovascular) age-related macular
degeneration (“wet AMD”). Pursuant to para 4.1 of
the agreement, the Investor has committed to
provide Opthea with US$120 million, of which US$50
million was paid in September 2022 and US$35
million was paid in December 2022.
The remainder of the funds of $35 million will be
funded in one additional tranche to be paid on or
before December 31, 2023.
Pursuant to the DFA, Opthea is required to use
commercially reasonable efforts to develop OPT-302
for the treatment of wet AMD in accordance with
the DFA, including pursuant to certain development
timelines set forth therein.
In return, Opthea will pay to the Investor:
•
Upon, the first to occur, regulatory approval of
OPT-302 for the treatment of wet AMD in the
United States, United Kingdom or European
Union (“Regulatory Approval”), fixed payments
equal to a total of approximately two times the
funding provided, consisting of seven payments,
with the first payment due shortly after
Regulatory Approval and the remaining six
annual payments payable over a six-year period
thereafter, and
•
variable payments equal to 7% of net sales of
OPT-302 for the treatment of wet AMD for each
calendar quarter. The fixed and variable
payment obligation discharge once the Investor
has received a total of four times their
investment.
In conjunction with our accounting and international tax
specialists, our procedures included, but were not limited
to:
•
Assessing the design and implementation of relevant
controls in relation to management's accounting for
non-routine transactions.
•
Assessing and challenging the accounting treatment of
the funding arrangement in conjunction with
our technical accounting specialists.
•
Reviewing and assessing management's position paper
addressing the tax treatment of the funding
arrangement including the use of managements and
our tax specialists.
•
Assessing the accounting policy adopted by the Group
to account for the DFA in accordance with IFRS 9.
•
Assessing
the
key
assumptions
adopted
by
management as well as the mathematical accuracy of
the effective interest rate, including withholding tax
considerations.
•
Assessing the fair value remeasurement of the financial
liability considering the change in management's
assumption around the timing of the first regulatory
approval of OPT-302.
We also assessed the adequacy of the disclosures in Note 2,
4.2, 13 and 25 to the financial statements.
Annual Report 2022 – 2023
93
Independent Auditor’s Report (cont.)
Key Audit Matter
How the scope of our audit responded to the Key Audit
Matter
Management exercised judgement in respect of the
DFA including:
•
Determining whether the arrangement is a
financial liability or equity.
•
Determining whether there is an embedded
derivative.
•
Determining the fair value of the financial
liability at initial recognition.
•
Determining the accounting policy for initial and
subsequent measurement.
•
Determining the effective interest rate
•
Determining the tax considerations relating to
the instrument.
We have therefore spent significant audit effort,
including the time of senior members of our audit
team, in assessing the appropriateness of these
assumptions.
Research and development tax incentive
The Group operates in the biotechnology market
and is in the clinical research stage of developing a
molecule asset, OPT-302, for the treatment of wet
(neovascular) age-related macular degeneration
(“wet AMD”).
The Group claims Research & Development tax
incentives ("R&D tax incentives") provided by the
Australian Government as disclosed in Note 4.1.
For the year ended 30 June 2023, the Group has
recognised an R&D tax incentive receivable of $5.9
million within the consolidated statement of
financial position, with a corresponding amount
recognised within income tax benefit within the
consolidated statement of profit or loss and other
comprehensive income.
Management exercises significant judgement in
respect of R&D tax incentives claimed by the Group
including:
•
Determining the accounting policy used in
accounting for the R&D tax incentive.
•
Assessing the eligibility of R&D activities and
costs attributed to those eligible R&D activities
against the rules and regulations governing the
R&D tax incentive.
•
Determining the estimated amounts, timing
and geographical location of costs related to
the projects for which R&D tax incentive
applications have been approved to date.
Our procedures included, but were not limited to:
•
Assessing the design and implementation of key
controls in relation to R&D expenditure and the
preparation and review of the R&D tax incentive
calculation; and
•
Assessing the accounting policy adopted by the Group
to account for the R&D tax incentive.
In conjunction with our R&D tax specialists we performed
the following procedures:
•
Obtaining an understanding of the rules and
regulations governing R&D tax incentives and the
basis used by the Group to recognise the incentive.
•
Assessing the work performed by the Group's external
R&D tax advisors to understand the process for the
preparation and review of the R&D tax incentive
submissions.
•
Assessing the competency and scope of the Group’s
external R&D tax advisors.
•
Assessing management's documentation addressing
how the Group's R&D activities satisfy the eligibility
criteria outlined in the rules and regulations governing
the R&D tax incentives.
•
On a sample basis, inspecting R&D expenses to
supporting documentation.
•
Testing on a sample basis, management's
apportionment of costs to these R&D activities and
whether the underlying methodology used for the
apportionment is consistent with the rules and
regulations governing the R&D tax incentive.
•
Assessing management's R&D project cost claimed for
tax incentives for eligible activities, including assessing
the amounts claimed, timing and geographical
location of the costs incurred.
94
Opthea Limited
Independent Auditor’s Report (cont.)
Key Audit Matter
How the scope of our audit responded to the Key Audit
Matter
We have therefore spent significant audit effort,
including the time of senior members of our audit
team, in assessing the appropriateness of these
assumptions.
We also assessed the adequacy of the disclosures in Note
3, 4.1 and 15 to the financial statements.
Other Information
The directors are responsible for the other information. The other information comprises the information included
in the Group’s annual report for the year ended 30 June 2023, but does not include the financial report and our
auditor’s report thereon.
Our opinion on the financial report does not cover the other information and accordingly we do not and will not
express any form of assurance conclusion thereon.
In connection with our audit of the financial report, our responsibility is to read the other information and, in doing
so, consider whether the other information is materially inconsistent with the financial report or our knowledge
obtained in the audit, or otherwise appears to be materially misstated. If, based on the work we have performed,
we conclude that there is a material misstatement of this other information, we are required to report that fact.
We have nothing to report in this regard.
Responsibilities of the Directors for the Financial Report
The directors of the Company are responsible for the preparation of the financial report that gives a true and fair
view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal
control as the directors determine is necessary to enable the preparation of the financial report that gives a true
and fair view and is free from material misstatement, whether due to fraud or error.
In preparing the financial report, the directors are responsible for assessing the ability of the Group to continue as
a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of
accounting unless the directors either intend to liquidate the Group or to cease operations, or have no realistic
alternative but to do so.
Auditor’s Responsibilities for the Audit of the Financial Report
Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from
material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance
with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements
can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably
be expected to influence the economic decisions of users taken on the basis of this financial report.
As part of an audit in accordance with the Australian Auditing Standards, we exercise professional judgement and
maintain professional scepticism throughout the audit. We also:
•
Identify and assess the risks of material misstatement of the financial report, whether due to fraud or error,
design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and
appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from
fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions,
misrepresentations, or the override of internal control.
•
Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Group’s internal control.
•
Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and
related disclosures made by the directors.
Annual Report 2022 – 2023
95
Independent Auditor’s Report (cont.)
•
Conclude on the appropriateness of the directors’ use of the going concern basis of accounting and, based on
the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may
cast significant doubt on the Group’s ability to continue as a going concern. If we conclude that a material
uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the
financial report or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the
audit evidence obtained up to the date of our auditor’s report. However, future events or conditions may cause
the Group to cease to continue as a going concern.
•
Evaluate the overall presentation, structure and content of the financial report, including the disclosures, and
whether the financial report represents the underlying transactions and events in a manner that achieves fair
presentation.
•
Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business
activities within the Group to express an opinion on the financial report. We are responsible for the direction,
supervision and performance of the Group audit. We remain solely responsible for our audit opinion.
We communicate with the directors regarding, among other matters, the planned scope and timing of the audit
and significant audit findings, including any significant deficiencies in internal control that we identify during our
audit.
We also provide the directors with a statement that we have complied with relevant ethical requirements regarding
independence, and to communicate with them all relationships and other matters that may reasonably be thought
to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied.
From the matters communicated with the directors, we determine those matters that were of most significance in
the audit of the financial report of the current period and are therefore the key audit matters. We describe these
matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in
extremely rare circumstances, we determine that a matter should not be communicated in our report because the
adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such
communication.
Report on the Remuneration Report
Opinion on the Remuneration Report
We have audited the Remuneration Report included in pages 31 to 45 of the Directors’ Report for the year ended
30 June 2023.
In our opinion, the Remuneration Report of Opthea Limited, for the year ended 30 June 2023 complies with section
300A of the Corporations Act 2001.
Responsibilities
The directors of the Company are responsible for the preparation and presentation of the Remuneration Report in
accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the
Remuneration Report, based on our audit conducted in accordance with Australian Auditing Standards.
DELOITTE TOUCHE TOHMATSU
Vincent Snijders
Partner
Chartered Accountants
Parramatta, 28 September 2023
96
Opthea Limited
Additional Information
Risk factors
Opthea’s activities will require substantial expenditures. Opthea’s losses from operations, including from clinical trial activities,
and negative cash flows, raise substantial doubt about the ability for the Company to continue as a going concern without additional
capital raising activities. Opthea completed the Equity Financing in two tranches, the first closing of A$73 million (US$47 million)
which was received on September 1, 2023, and a second closing of A$17 million (US$11 million) on September 20, 2023. In addition,
a new co-investor of Carlyle and Abingworth intends to participate in a funding under the DFA of US$50 million to increase
total DFA funding from US$120 million to US$170 million, which is subject to the co-investor’s final due diligence and receipt
of regulatory and tax approvals, appropriate documentation and compliance with closing conditions. There can be no assurance
that the new co-investor of Carlyle and Abingworth will increase the funding by US$50 million.
While Opthea expects that the proceeds of the Equity Financing of A$90 million (approximately US$58 million), together with
additional funding expected under the DFA of US$35 million due under the DFA by December 31, 2023, the possible increased
funding under the DFA of US$50 million and cash on hand, will provide funding to progress the activities of the Group for the
next twelve months, such proceeds will not be sufficient to fully fund all anticipated costs of the Phase 3 clinical trials to top-line
data. In addition, the forecast of Opthea’s cash runway, following receipt of the proceeds from the Equity Financing and under
the DFA, is subject to a number of assumptions, including the timing of completion of Phase 3 clinical trial patient enrollment
and Clinical Research Organization (“CRO”) and labor costs. Estimated patient enrollment timing used for Opthea’s forecast of its
cash runway is based on Opthea’s monthly enrollment rates for its Phase 3 clinical trials, which timing has in the past significantly
fluctuated from prior estimates, including due to factors outside Opthea’s control. Opthea has in the past incurred significantly
increased costs in connection with the activities conducted by third party CROs and other service providers to prepare for and
progress its Phase 3 clinical trials and may continue to incur higher than expected costs for such activities in the future. CRO and
related costs for the Phase 3 clinical trials have also significantly fluctuated from estimates in the past, including factors outside
Opthea’s control. If patient enrollment continues to be delayed in the future, or if any additional factors cause the Phase 3 clinical
trials to be further delayed or more costly, including higher than expected CRO and labor costs, then the Company will need to
obtain additional financing earlier than its forecast.
The third tranche of US$35 million is due under the terms of the DFA before December 31, 2023, however, in the event
the US$35 million is not paid it would be considered a Fundamental Material Breach of the DFA by Carlyle and Abingworth.
Under a Fundamental Material Breach of the DFA, Opthea has limited recourse but would have the ability to terminate the DFA
by Carlyle and Abingworth. Termination by Opthea for lack of payment by Carlyle and Abingworth of the US$35 million would
relieve Opthea from any repayments under the DFA. Failure to receive the third tranche of US$35 million or the increased funding
of US$50 million would have a negative impact on the Company’s cash runway and its ability to complete enrollment in the
ongoing trials.
In addition, if Opthea is unable to obtain the increased US$50 million of funding under the DFA, then Opthea will need to seek
additional capital from other sources, which may not be available on a timely basis or at all. If Opthea fails to obtain additional
capital from other sources prior to top-line data for its Phase 3 clinical trials, which may not be available on a timely basis or at all,
Opthea could be forced to delay, limit or terminate its operations, liquidate all or a portion of its assets and/or seek insolvency
protection in the near term. Opthea’s failure to raise capital prior to top=line data for its Phase 3 clinical trials, if and when needed,
could delay or suspend Opthea’s business strategy and could have a material adverse effect on Opthea’s activities. If additional
funds are raised by issuing equity, this may result in additional dilution to Opthea’s shareholders. The pricing of future security
issues will also depend on the results of Opthea’s scientific research projects, market factors, demand for securities and the need
for capital. If Opthea is unable to secure funding in the short term, there is a risk that Opthea will not be able to
continue operating.
Other risk factors that are relevant to Opthea are described in the section titled “Risk Factors” in Opthea’s Annual Report on
Form 20-F filed with the SEC on October 28, 2022 and under “Key Risks” in Opthea’s investor presentation included as an exhibit
to Form 6-K furnished with the SEC on August 24, 2023, and include but are not limited to the risks that we are a clinical-stage
biopharmaceutical company with no products approved for commercial sale; we have incurred net losses since our inception,
we expect to incur significant losses and increasing operating losses for the foreseeable future, and we may never be profitable;
we will require substantial additional capital to finance our operations, which may not be available to us on acceptable terms,
or at all, as a result, we may not complete the development and commercialization of Sozinibercept (OPT-302) or develop new
product candidates; failure to remain in compliance with our obligations under the Development Funding Agreement with Ocelot
could lead to reduced funding under the agreement and/or the acceleration of potentially significant payments to Ocelot; and
we have in the past encountered difficulties in enrolling patients in our clinical trials and if we encounter such difficulties in the
future, our clinical development activities could be delayed or otherwise negatively affected.
Annual Report 2022 – 2023
97
ASX Additional Information
1. Distribution of equity securities
The number of shareholders, by size of holding, of quoted fully paid ordinary shares as at August 31, 2023 is as follows:
Fully paid ordinary shares
Category
No. of holders
No. of shares
1 – 1,000
2,623
1,438,892
1,001 – 5,000
2,758
7,296,827
5,001 – 10,000
886
6,880,051
10,001 – 100,000
1,025
29,827,608
100,001 and Over
156
421,716,056
Total
7,448
467,159,434
Number of shareholders holding less than a marketable parcel of shares
2,786
1,615,256
2. Twenty largest shareholders
The names of the 20 largest holders of quoted fully paid ordinary shares and their respective holdings at August 31, 2023 are:
Rank
Name
No. of shares
% interest
1
HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED
113,819,968
24.36%
2
CITICORP NOMINEES PTY LIMITED
61,449,070
13.15%
3
USB NOMINEES PTY LTD
35,562,811
7.61%
4
JP MORGAN NOMINEES AUSTRALIA PTY LIMITED
34,576,016
7.40%
5
MERRILL LYNCH (AUSTRALIA) NOMINEES PTY LIMITED
23,329,680
4.99%
6
NATIONAL NOMINEES LIMITED
22,739,390
4.87%
7
BNP PARIBAS NOMS PTY LTD
6,875,408
1.47%
10
HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED
5,762,622
1.23%
11
HSBC CUSTODY NOMINEES (Australia) LIMITED – A/C 2
5,519,023
1.18%
12
MS MARGARET LYNETTE HARVEY
5,268,323
1.13%
13
ARMADA TRADING PTY LIMITED
5,005,806
1.07%
14
SAFO TRADING PTY LTD
3,641,130
0.78%
15
GAJA HOLDINGS
3,207,576
0.69%
16
SAFO INVESTMENTS PTY LTD
3,039,766
0.65%
17
HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED
3,000,000
0.64%
18
BILGOLA NOMINEES PTY LIMITED
2,934,490
0.63%
19
SUIBIAN TRADING PTY LTD
2,933,644
0.63%
20
SANDHURST TRUSTEES LTD
2,561,995
0.55%
Totals: Top 20 holders of ordinary fully paid shares
368,664,160
78.92%
Total remaining holders balance
98,495,274
21.08%
98
Opthea Limited
ASX Additional Information (cont.)
3. Substantial shareholders
The following information is current at August 31, 2023 based on information extracted from the substantial shareholding
notices given to the Company by shareholders who hold relevant interests in more than 5 per cent of the Company’s
voting shares:
Name
No. of shares
Regal Funds Management Pty Ltd
93,246,599
Bakers Brothers Life Sciences LP
31,627,844
USB Group AG and its related bodies corporate
33,322,088
Bank of America Corporation and its related bodies corporate
23,425,608
4. Voting Rights
Clauses 44 to 53 of the Company’s Constitution stipulate the voting rights of members. In summary, but without prejudice to
the provisions of the Constitution, every member present in person or by representative, proxy or attorney shall have one vote
for each ordinary share held by the member.
The Company’s shares are quoted on the Australian Securities Exchange Limited (ASX code: OPT).
Annual Report 2022 – 2023
99
Corporate Directory
Company
Opthea Limited
ABN 32 006 340 567
Directors
Jeremy Levin
Non‑Executive Director and Chairman
Megan Baldwin
Managing Director and Chief Executive Officer
Lawrence Gozlan
Non‑Executive Director
Anshul Thakral
Non-Executive Director
Daniel Spiegelman
Non‑Executive Director
Julia Haller
Non‑Executive Director
Susan Orr
Non‑Executive Director
Quinton Oswald
Non-Executive Director
Company Secretary
Karen Adams
BBus, CPA GAICD,FGIA FCG
Registered office
Level 4, 650 Chapel Street
South Yarra, Victoria 3141
US Office
103 Carnegie Center Boulevard,
Suite 300, Princeton NJ, 08540
Principal administrative office
Level 4, 650 Chapel Street
South Yarra, Victoria 3141
www.opthea.com
Telephone: +61 (3) 9826 0399
Bankers
Commonwealth Bank of Australia
Melbourne, Victoria
Auditors
Deloitte Touche Tohmatsu
8 Parramatta Square
Level 37, 10 Darcy Street
Parramatta, NSW 2150
Australia
Solicitors
Gilbert and Tobin
101 Collins Street
Melbourne, Victoria 3000
Cooley LLP
3175 Hanover Street,
Palo Alto, CA, 94304
USA
Share register
Computershare Investor Services Pty Ltd
Yarra Falls, 452 Johnston Street
Abbotsford, Victoria 3067
Telephone: +61 (3) 9415 4000 or
1300 850 505 (within Australia)
Stock exchange listing
Opthea Limited’s shares are quoted on the Australian
Securities Exchange Limited ASX (code: OPT).
Opthea Limited American Depositary Shares (“ADS”) options
are quoted on the National Association of Securities Dealers
Automated Quotations (“NASDAQ”) Stock Market (code: OPT).
100
Opthea Limited
colliercreative.com.au #OPT0038
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Annual Report 2022 – 2023
101
opthea.com