28 August 2024
PureTech Health plc -
Half-Year Report
Strong progress across
PureTech's portfolio, with significant near-term
catalysts
Robust shareholder returns
enabled by Founded Entity1 monetization; $100 million
Tender Offer and
$50 million buyback completed
Strong balance sheet with
expected operational runway for at least three
years
Company to host a webcast
and conference call today at 9:00am EDT / 2:00pm
BST
PureTech Health plc (Nasdaq: PRTC,
LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage
biotherapeutics company dedicated to changing the lives of patients
with devastating diseases, today announces its half-yearly results
for the six months ended June 30, 2024. The following information
will be filed on Form 6-K with the United States Securities and
Exchange Commission (the "SEC") and is also available at
https://investors.puretechhealth.com/financials-filings/reports.
Commenting
on PureTech's half-yearly results, Bharatt Chowrira, PhD, JD, Chief
Executive Officer of PureTech, said:
"I am proud of the talented team
at PureTech that has continued to deliver results with a sense of
diligence and passion. PureTech made significant progress in the
first half of 2024, advancing our mission to develop innovative
therapies for the patients most in need. We have also implemented
strategies to drive efficient operations and capital allocation.
This has resulted in a decrease in both our R&D and G&A
expenses at the PureTech level.
"Looking ahead, we are focused on
several key catalysts. The highly anticipated FDA decision around
the approval of KarXT, which is expected by Bristol Myers Squibb
("BMS") in September, would unlock the first in a series of
milestone payments to PureTech in the coming years as well as
future royalties. We are also very excited about the readout of our
Phase 2b trial from our Internal Program, LYT-100 (deupirfenidone),
which is expected by the end of 2024. We believe LYT-100 has
blockbuster potential to transform the treatment landscape for
patients with idiopathic pulmonary fibrosis ("IPF") as the
preferred standard of care, driving significant value for PureTech.
Additionally, we expect clinical readouts from both the Vor and
LYT-200 programs as well as further clinical progress at Seaport
and Vedanta.
"With our robust hub-and-spoke
drug discovery and development model and strong financial
foundation, we believe PureTech is well-positioned to rapidly
advance innovative therapeutic candidates to patients, and we
remain committed to unlocking and realizing value for our
shareholders."
Webcast and conference call details
Members of
the PureTech management team will host a conference call
at 9:00am EDT / 2:00pm BST today, August
28, 2024, to discuss these results. A live webcast and presentation
slides will be available on the investors section
of PureTech's website under the Events and
Presentations tab. To join by phone,
please dial:
United Kingdom (Local): +44 20
3936 2999
United Kingdom (Toll-Free): +44 800 358 1035
United States (Local): +1 646
664 1960
United States (Toll Free): +1
855 9796 654
Access
Code: 808029
For those unable to listen to the
call live, a replay will be available on
the PureTech website.
Key Internal Programs2 & Founded
Entities
Internal Programs
|
Ownership
|
Indication
|
LYT-100
(deupirfenidone)
|
100%
|
Being advanced for idiopathic
pulmonary fibrosis and potentially other conditions involving
pulmonary fibrosis
|
Founded Entities
|
Ownership3
|
Overview
|
Seaport Therapeutics
|
57.7% Equity
|
Advancing a clinical-stage pipeline
of neuropsychiatric medicines
|
Karuna Therapeutics
(wholly owned subsidiary of Bristol Myers Squibb as of March
18, 2024)
|
Regulatory and commercial milestone
payments from Royalty Pharma (up to $400M) and BMS, and 2%
royalties on annual net sales >$2B from BMS
|
Advancing transformative medicines
for people living with psychiatric and neurological
conditions
|
Gallop Oncology
|
100% Equity
|
Pioneering novel therapies for the
treatment of hematological malignancies, alongside treatments for
locally advanced/metastatic solid tumors such as head and neck
cancers
|
Vedanta Biosciences
|
35.9% Equity
|
Pioneering a new category of oral
therapies based on defined bacterial consortia
|
Vor Bio
|
3.9% Equity
|
Engineering hematopoietic stem
cells to enable targeted therapies for patients with blood
cancers
|
Sonde Health
|
34.9% Equity
|
Developing a voice-based artificial
intelligence platform to detect changes in health
|
Entrega
|
73.8% Equity
|
Engineering hydrogels to enable the
oral administration of peptide therapeutics (e.g., GLP-1
agonists)
|
Highlights
PureTech
• Completed enrollment of the Phase 2b
ELEVATE IPF trial of LYT-100 (deupirfenidone) in IPF, with topline
results expected by the end of 2024.
• Executed $100 million tender offer,
which - together with the Company's $50 million share buyback
program that completed on February 7, 2024 - constituted $150
million of capital returned to shareholders since May 2022.
• Appointed key executives, including
Bharatt Chowrira, PhD, JD, as Chief Executive Officer (formerly
President and Chief Business, Finance and Operating Officer), Eric
Elenko, PhD, as President (formerly Chief Innovation Officer),
Charles Sherwood III, JD, as General Counsel, and Raju
Kucherlapati, PhD as Chair of the Board of Directors on a permanent
basis.
• Welcomed two entrepreneurs-in-residence:
Sven Dethlefs, PhD, formerly Executive Vice President and CEO of
Teva North America, and Luba Greenwood, JD, Managing Partner of the
Dana-Farber Cancer Institute Venture Fund, Binney Street Capital,
and former Chief Executive Officer and Board Chair of Kojin
Therapeutics.
• Announced in the August 2024 post-period
that Michele Holcomb, PhD, will join PureTech's Board of Directors
as an independent non-executive director on September 23, 2024.
Founded Entities
• Karuna Therapeutics ("Karuna") was acquired by
BMS in March 2024 for a total equity value of $14 billion. PureTech
received approximately $293 million gross proceeds from its equity
position in Karuna and is eligible to receive up to $400 million in
future milestone payments as well as royalty payments based on
KarXT regulatory and commercial successes.
• PureTech launched Seaport Therapeutics ("Seaport") with a
$100 million oversubscribed Series A financing to progress the
development of novel neuropsychiatric therapeutic candidates
enabled by Glyph™, its novel platform that allows drugs to be
absorbed like dietary lipids so they can enter the lymphatic system
directly and avoid first pass metabolism. Seaport is led by
PureTech Founder and Former CEO and Seaport Founder and CEO Daphne
Zohar, with Steven M. Paul, M.D., former CEO and Chair of Karuna,
as Founder and Chair of the Seaport Board of Directors.
• PureTech announced that it will advance
LYT-200 (anti-galectin-9 mAb) via Gallop Oncology ("Gallop") for the
treatment of hematological malignancies, such as acute myeloid
leukemia ("AML") and high-risk myelodysplastic syndromes ("MDS"),
and metastatic/locally advanced solid tumors, including head and
neck cancers. LYT-200 received two designations from the US Food
and Drug Administration ("FDA"): Orphan Drug designation for the
treatment of AML and Fast Track designation for the treatment of
head and neck cancers.
• Vedanta
Biosciences ("Vedanta") enrolled the first patient in its
pivotal Phase 3 RESTORATiVE303 trial of VE303 for the prevention of
recurrent C. difficile infection ("rCDI"). Vedanta was also awarded
$3.9 million from CARB-X to ready VE707 for a first-in-human study
for the prevention of multidrug-resistant infections.
• Vor
Biopharma (Nasdaq: VOR) ("Vor") dosed the first AML patient
in VBP301, a Phase 1/2 multicenter, open-label, first-in-human
study of VCAR33ALLO and announced that it expects to
provide a clinical trial update in the second half of 2024.
• Sonde
Health ("Sonde") launched Sonde Cognitive Fitness in the
July post-period, which analyzes eight vocal characteristics from
30-second voice interactions to provide insight into one's
cognitive state, helping people manage their mental well-being and
productivity effectively.
• Entrega continues to advance its
platform for the oral administration of biologics, vaccines and
other drugs that are otherwise not efficiently absorbed when taken
orally. To validate its technology, Entrega generated preclinical
proof-of-concept data demonstrating administration of therapeutic
peptides into the bloodstream of large animals.
Financial:
• Consolidated Cash, cash equivalents and
short-term investments as of June 30, 2024, were $500.4
million4 (December 31, 2023: Consolidated Cash, cash
equivalents and short-term investments of $327.1 million) and
PureTech Level Cash, cash equivalents and short-term investments as
of June 30, 2024, were $400.6 million5 (December 31,
2023: PureTech Level Cash, cash equivalents and short-term
investments of $326.0 million)
• Operating expenses for the six months
ended June 30, 2024, were $66.7 million (June 30, 2023: $79.3
million).
• PureTech expects to have PureTech Level
Cash, cash equivalents and short-term investments of approximately
$330 million6 at December 31, 2024, which is inclusive
of expected payments of approximately $40 million to address the
Company's tax obligations. As of June 30, 2024, the Company
maintains an expected operational runway of at least three
years.
Key Upcoming Milestones
• PureTech expects topline results from
the Phase 2b ELEVATE IPF dose-ranging trial of LYT-100 in patients
with IPF by the end of 2024. The trial is designed to evaluate the
efficacy, tolerability, safety and dosing regimen of LYT-100 in
patients with IPF compared to placebo and will also assess the
relative efficacy of two doses of LYT-100. The primary endpoint is
the rate of decline in Forced Vital Capacity ("FVC") for the
combined LYT-100 arms versus placebo over the 26-week treatment
period using a prespecified Bayesian approach. Both doses of
LYT-100 will be compared to pirfenidone, though the trial is not
powered to show a statistical difference in efficacy between
LYT-100 and pirfenidone. We believe LYT-100 has the potential to
have a profound impact on the way IPF is managed by allowing
patients to start, continue and fully benefit from treatment, both
as monotherapy and in combination settings with other antifibrotic
therapies.
• KarXT (formerly Karuna; now wholly owned
by BMS) has a Prescription Drug User Fee Act ("PDUFA") date of
September 26, 2024, for the treatment of schizophrenia in adults,
which means the FDA is expected to make a decision regarding the
approval of KarXT by this date. If the drug is approved, this would
unlock the first in a series of potential milestone payments to
PureTech in the coming years as well as future royalties. Pending
approval, BMS also announced that KarXT is expected to launch in
late 2024.
• LYT-200 (which will be advanced via
Gallop) is being evaluated in two ongoing Phase 1b clinical trials
for the treatment of relapsed/refractory AML and MDS as well as in
combination with tislelizumab in head and neck cancers. Additional
data from the open label trials are expected in the fourth quarter
of 2024 and will help to inform future development work.
• Vor expects to provide clinical trial
updates for trem-cel and VCAR33ALLO in the second half
of 2024. Trem-cel is a shielded transplant in development for
patients with AML and MDS in which healthy transplant donor cells
are genetically engineered removing CD33, with the potential to
shield healthy cells and enable targeted therapies post-transplant
such as Mylotarg and CAR-T therapy. VCAR33ALLO is a
transplant donor-derived anti-CD33 CAR-T cell therapy for patients
with AML who have relapsed following a standard-of-care or trem-cel
transplant.
• Vedanta expects topline data from its
Phase 3 RESTORATiVE303 trial of VE303 for the prevention of rCDI in
2026. This trial is evaluating the efficacy and safety of VE303 in
patients with rCDI and is intended to form the basis for a
Biologics License Application ("BLA") to be filed with the FDA. It
also expects topline data from its Phase 2 COLLECTiVE202 clinical
trial of VE202 for the treatment of ulcerative colitis ("UC")in
2025. Vedanta also expects to initiate a Phase 1 trial of VE707 for
the prevention of multidrug-resistant infections in 2025.
About PureTech Health
PureTech is a clinical-stage
biotherapeutics company dedicated to giving life to new classes of
medicine to change the lives of patients with devastating diseases.
The Company has created a broad and deep pipeline through its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders that is being
advanced both internally and through its Founded
Entities. PureTech's R&D engine has resulted in the development
of 29 therapeutics and therapeutic candidates, including two that
have received both U.S. FDA clearance and European marketing
authorization and a third (KarXT) that has been filed for FDA
approval. A number of these programs are being advanced
by PureTech or its Founded Entities in various indications and
stages of clinical development, including registration enabling
studies. All of the underlying programs and platforms that resulted
in this pipeline of therapeutic candidates were initially
identified or discovered and then advanced by the PureTech team
through key validation points.
For more information,
visit www.puretechhealth.com or connect with us on X (formerly
Twitter) @puretechh.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. We intend such
forward-looking statements to be covered by the safe harbor
provisions for forward looking statements contained in Section 27A
of the U.S. Securities Act of 1933, as amended and Section 21E of
the Exchange Act of 1934, as amended. All statements contained in
this press release that do not relate to matters of historical fact
should be considered forward-looking statements, including without
limitation, statements that relate to our expectations around our
and our Founded Entities' therapeutic candidates and approach
towards addressing major diseases, operational plans, future
prospects, objectives, developments, strategies and expectations,
the progress and timing of clinical trials and data readouts, the
timing of regulatory approvals or clearances from the FDA, our
future results of operations and financial outlook, including our
anticipated cash runway and our forecasted cash, cash equivalents
and short-term investments, and our ability to realize value for
our shareholders.
The forward-looking statements are
based on current expectations and are subject to known and unknown
risks, uncertainties and other important factors that could cause
actual results, performance and achievements to differ materially
from current expectations, including, but not limited to, the
following: our history of incurring significant operating losses
since our inception; our ability to realize value from our Founded
Entities; our need for additional funding to achieve our business
goals, which may not be available and which may force us to delay,
limit or terminate certain of our therapeutic development efforts;
our limited information about and limited control or influence over
our Non-Controlled Founded Entities; the lengthy and expensive
process of preclinical and clinical drug development, which has an
uncertain outcome and potential for substantial delays; potential
difficulties with enrolling patients in clinical trials, which
could delay our clinical development activities; side effects,
adverse events or other safety risks which could be associated with
our therapeutic candidates and delay or halt their clinical
development; our ability to obtain regulatory approval for and
commercialize our therapeutic candidates; our ability to compete
with companies currently marketing or engaged in the development of
treatments for indications within our programs are designed to
target; our ability to realize the benefits of our collaborations,
licenses and other arrangements; the impact of government laws and
regulations; our ability to maintain and protect our intellectual
property rights; our reliance on third parties, including clinical
research organizations, clinical investigators and manufacturers;
our vulnerability to natural disasters, global economic factors,
geo-political actions and unexpected events; and the risks,
uncertainties and other important factors described under the
caption "Risk Factors" in our Annual Report on Form 20-F for the
year ended December 31, 2023 filed with the SEC and in our other
regulatory filings. These forward-looking statements are based on
assumptions regarding the present and future business strategies of
the Company and the environment in which it will operate in the
future. Each forward-looking statement speaks only as at the date
of this press release. Except as required by law and regulatory
requirements, we disclaim any obligation to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
1. As of
the date of this release, Founded Entities represent companies
founded by PureTech in which PureTech maintains ownership of an
equity interest and, in certain cases, is eligible to receive
sublicense income and royalties on product sales. References to
Founded Entities include PureTech's Seaport Therapeutics, Inc.,
Gallop Oncology, Inc., Entrega, Inc., Vor Biopharma, Inc., Sonde
Health, Inc., Vedanta Biosciences, Inc., for all dates prior to
March 18, 2024, Karuna Therapeutics, Inc., for all dates prior to
July 2, 2024, Akili Interactive Labs, Inc., for all dates prior to
October 30, 2023, Gelesis, Inc., for all dates prior to December
21, 2023, Follica, Incorporated, and for all dates prior to
December 18, 2019, resTORbio, Inc. For references and definitions
related to PureTech's Viability Statement, Financial Review, and
Financial Statements and related footnotes, please see Footnote 4
to the Consolidated Financial Statements.
2
Internal Programs represent the Company's current and future
therapeutic candidates and technologies that are wholly owned and
have not been announced as a Founded Entity.
3
Founded Entities represent companies founded by PureTech in which
PureTech maintains ownership of an equity interest and, in certain
cases, is eligible to receive sublicense income and royalties on
product sales. Relevant ownership interests were calculated on a
partially diluted basis (as opposed to a voting basis) as of June
30, 2024, including outstanding shares, options and warrants, but
excluding unallocated shares authorized to be issued pursuant to
equity incentive plans. PureTech controls Seaport Therapeutics,
Inc. and Gallop Oncology, Inc. Vor Biopharma ownership was
calculated on a beneficial ownership basis in accordance with SEC
rules as of August 2, 2024.
4
Cash, cash equivalents and short-term investments as of June 30,
2024, and as of December 31, 2023 held at PureTech Health plc and
consolidated subsidiaries. For more information, please see below
under the heading "Non-IFRS Financial Information."
5
This represents a non-IFRS number and is
comprised of Cash, cash equivalents and short-term investments held
at PureTech Health plc and our following wholly-owned subsidiaries:
PureTech LYT, Inc., PureTech LYT 100, Inc., Alivio Therapeutics,
Inc., PureTech Management, Inc., PureTech Health LLC, PureTech
Securities Corp., PureTech Securities II Corp. For a reconciliation
of this number to the IFRS equivalent number, please refer to the
"Non-IFRS Financial Information" section of this
report.
6
This represents a non-IFRS number and
is comprised of Cash, cash equivalents and short-term investments
held at PureTech Health plc and our following wholly-owned owned
subsidiaries: PureTech LYT, Inc., PureTech LYT 100, Inc., Alivio
Therapeutics, Inc., PureTech Management, Inc., PureTech Health LLC,
PureTech Securities Corp, PureTech Securities II. We are not
able to provide a reconciliation of this forecasted number to the
IFRS equivalent number because PureTech Level Cash, cash
equivalents and Short-term investments as of December 31, 2024, is
contingent on upon a number of factors, certain of which cannot be
predicted on a forward-looking basis without unreasonable efforts
or are not within our control. Actual PureTech Level Cash, Cash
Equivalents and Short-term investments as of December 31, 2024, may
differ significantly from this projection. This projection does not
include any potential cash inflows that may be received by the
Company prior to December 31, 2024, and may be impacted by factors
beyond our control, including unanticipated cash expenditures and
changes in the value of short-term investments.
Non-IFRS Financial Information
Cash flow and liquidity
|
|
PureTech Level cash, cash
equivalents and short-term investments
|
Measure type: Core
performance
|
Definition: Cash and cash
equivalents and short-term investments held at PureTech Health plc
and our wholly-owned subsidiaries.
|
|
Why we use it: PureTech Level
cash, cash equivalents and short-term investments is a measure that
provides valuable additional information with respect to cash, cash
equivalents and short-term investments available to fund the
Wholly-Owned Programs and make certain investments in Founded
Entities.
|
Non-IFRS Measures Reconciliation
The following is the
reconciliation of the amounts appearing in our Condensed
Consolidated Statement of Financial Position to the alternative
performance measure described above:
(in thousands)
|
June 30,
2024
|
December
31, 2023
|
Cash and cash
equivalents
|
308,478
|
191,081
|
Short-term investments
|
191,938
|
136,062
|
Consolidated cash, cash equivalents
and short-term investments
|
500,416
|
327,143
|
Less: cash and cash equivalents
held at non-wholly owned subsidiaries
|
(99,778)
|
(1,097)
|
PureTech Level cash, cash
equivalents and short-term investments
|
$400,638
|
$326,046
|
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
UK/EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
puretech@fticonsulting.com
US
Media
Nichole Bobbyn
+1 774 278 8273
nichole@tenbridgecommunications.com
Interim Management Report and
Financial Review
Interim Management Report
Introduction
PureTech's core mission is to give
life to new classes of medicine to change the lives of patients
with devastating diseases. With this mission in mind, we pioneered
the hub-and-spoke business model. Our R&D engine has proven
successful in this endeavor, having identified, developed and
progressed 29 highly differentiated therapeutic approaches,
including KarXT, LYT-100 (deupirfenidone) and the portfolio of
Seaport Therapeutics, among others. We maintain one of the most
impressive track records in the biopharma industry, with more than
80% of our clinical trials having demonstrated success since
2009.
Unique drug discovery approach
We believe that our high level of
productivity and clinical success is a result of our distinctive
approach to drug development. We first identify an area with
significant patient need. We then explore therapeutic approaches
that often have validated human efficacy but have not yet reached
their full potential due to key limitations, such as the route of
administration or side effects. Next, we work to unlock a potential
new medicine's full benefit while executing efficient de-risking
experiments. We adhere to disciplined R&D strategies, and we
only allocate resources to programs that reach our pre-specified
thresholds for advancement. This allows us to pivot resources
towards the programs with the greatest likelihood of advancement
and has resulted in our success rate. Once a program has achieved a
key value-generating inflection point, we determine whether the
best path forward to maximize patient benefit and shareholder value
is through continued internal development or via a Founded Entity,
an asset sale, and/or partnering and royalty
transactions.
We intend to utilize the same
proven strategy to determine the ideal path for the advancement of
our Internal Program, LYT-100, following the results of the Phase
2b trial by the end of this year. We will be guided by the data,
and we will pursue the optimal route to deliver this potentially
transformational medicine to patients and generate value for our
shareholders.
Efficient funding model
Our Founded Entities serve as
specialized platforms to pursue development with external partners,
supporting timely progress of novel medicines to patients while
also mitigating binary risk through a diverse portfolio. KarXT
demonstrates how our Founded Entities are able to generate value
for our shareholders, while also demonstrating our capital
efficient approach. We allocated $18.5 million to the program, and
- in addition to transforming the treatment landscape for patients
with schizophrenia -Karuna's success has allowed us to generate
approximately $1.1 billion in cash to date to fund our operations,
fuel our next wave of innovation and return capital to
shareholders. This has been realized through the monetization of a
portion of our holdings in Karuna, gross proceeds from the BMS
acquisition, and a strategic royalty agreement for KarXT with
Royalty Pharma that provided us with capital in the short-term and
which we believe has great potential for long-term earnings based
on KarXT's future regulatory and commercial milestones, as well as
product sales.
Our distinct business model and
successes like Karuna have enabled us to be a well-capitalized
organization: For more than six years we have been able to fund new
and maturing programs to key inflection points without external
funding at the PureTech Level, we have returned $150 million to
shareholders via our share buyback program and Tender Offer, and -
going forward - we aim to maintain at least three years of cash
runway.
Commitment to shareholder value
Maximizing long-term shareholder
value remains the Company's top priority, and the Board and
Management Team conduct a continual review of various strategies in
order to unlock and crystallize value for shareholders. In doing
so, the board aims to balance (1) opportunities for further capital
returns, (2) sourcing and development efforts to grow our portfolio
of potential new medicines and (3) support for our current programs
and Founded Entities, all while serving patients in
need.
PureTech's expertise builds on a
rich legacy of innovation. It spans the lifecycle of drug
development, is infused with scientific entrepreneurship and
maintains a capital efficient ethos. As we look towards the
development of our next wave of innovation, we are focused on
advancing candidates with validated efficacy within the rare and
specialty disease spaces, and we look forward to providing updates
in due course.
Notable Developments
Internal Programs
Our Internal Programs are guided
by a strategy of leveraging validated efficacy to rapidly advance
therapeutics with proven profiles. A deeper level of risk
management at every stage of development is core to PureTech's
development philosophy. Importantly, our approach prioritizes
maintaining the validated pharmacology of efficacious drugs while
applying an innovative step to maximize their unrealized potential
for patient needs.
Our lead Internal Program,
LYT-100
(deupirfenidone), is currently in
clinical development for IPF, which is a rare, progressive and
fatal lung disease with a median survival of 2-5 years.1
Pirfenidone (Esbriet®) is approved for the treatment of IPF in the
US and other countries, having been shown to slow the decline of
lung function and extend life by an average of 2.5
years.1 It is one of two standard-of-care treatments for
IPF, with nintedanib (Ofev®) being the other. Despite the proven
efficacy of both treatments, only about 25 percent of patients with
this rare, progressive and fatal disease are currently being
treated with either standard-of-care drug,2 largely due
to tolerability issues. Furthermore, combined sales of Esbriet and
Ofev in 2022 were more than $4 billion, representing a significant
market opportunity in IPF and other fibrotic lung
diseases.3
LYT-100 maintains the pharmacology
of pirfenidone but has a highly differentiated pharmacokinetic
profile that has translated into favorable tolerability, as
demonstrated by data from multiple human clinical studies. Our goal
with the ongoing Phase 2b ELEVATE IPF trial is to validate the
ability of LYT-100 to demonstrate a favorable tolerability profile
and efficacy that's comparable to pirfenidone, while also exploring
the potential for enhanced efficacy at a higher dose. Based on
clinical data generated to date, we believe that LYT-100 has the
potential to disrupt the treatment paradigm for IPF and become the
backbone antifibrotic for a range of combination therapies as well
as the preferred monotherapy for IPF patients, including the 75%
who are not currently on standard-of-care treatment. The trial is
fully enrolled, and we look forward to sharing topline results by
the end of 2024.
This program is emblematic of
PureTech's strategy. We identified a clear patient need with a
large market opportunity and are efficiently advancing a drug
candidate with a clear development path and existing clinical
validation.
Founded Entities
Our Founded Entities have achieved
significant milestones in the first half of 2024.
In March 2024, Karuna
was acquired by BMS for approximately $14
billion, marking a significant advancement in our Founded Entity's
mission to deliver transformative medicines for people living with
psychiatric and neurological conditions. Karuna is now a wholly
owned subsidiary of BMS, and Karuna's lead candidate, KarXT, has
been granted a PDUFA date of September 26, 2024, for the treatment
of schizophrenia in adults. If the drug is approved, this would
unlock the first in a series of potential milestone payments to
PureTech in the coming years as well as future royalties. Pending
approval, BMS also announced that KarXT is expected to launch in
late 2024.
In April 2024, PureTech
launched Seaport with a $100 million
oversubscribed Series A financing. The funding included
participation from top tier biotech investors ARCH Venture
Partners, Sofinnova Investments and Third Rock Ventures to progress
the development of neuropsychiatric therapeutic candidates
initially developed internally at PureTech. Seaport is advancing
first and best-in-class medicines for the treatment of
neuropsychiatric disorders using the Glyph platform. The Glyph
platform is uniquely designed to allow drugs to be taken orally by
targeting them directly into the lymphatic system (similar to the
way a dietary lipid is absorbed) rather than the liver, which helps
to reduce liver toxicities and enables more active drug to reach
the desired target in the body. Seaport's pipeline includes,
SPT-300 (formerly LYT-300), an oral prodrug of allopregnanolone,
which is being advanced for the treatment of major depressive
disorder; SPT-320 (formerly LYT-320), a novel prodrug of
agomelatine, which is being advanced for the treatment of
generalized anxiety disorder; and SPT-348, a prodrug of a
non-hallucinogenic neuroplastogen, which is in development for the
treatment of mood and other neuropsychiatric disorders.
We also announced that we would be
advancing LYT-200 (anti-galectin-9 mAb) through another Founded
Entity, Gallop, for
the treatment of hematological malignancies, such as AML and
high-risk MDS, as well as metastatic/locally advanced solid tumors,
including head and neck cancers. LYT-200 has displayed a favorable
safety and tolerability profile in two ongoing Phase 1b clinical
trials - one in AML and another in combination with BeiGene's
tislelizumab in head and neck cancers. The Phase 1b clinical trial
evaluating LYT-200 in relapsed/refractory AML and MDS patients is
ongoing, and we expect additional data from the trial will be
presented in a scientific forum in the fourth quarter of 2024.
Also, the Phase 1b trial of LYT-200 in combination with
tislelizumab in head and neck cancers is ongoing, with additional
data expected in the fourth quarter of 2024. In 2024, the FDA
granted LYT-200 Orphan Drug designation for the treatment of AML as
well as Fast Track designation for the treatment of head and neck
cancers.
Vedanta further advanced the
development of a potential new category of oral therapies utilizing
defined consortia of bacteria isolated from the human microbiome
and grown from pure clonal cell banks. In May 2024, Vedanta
announced that the first patient was dosed in the global Phase 3
RESTORATiVE303 clinical study of VE303, which is an orally
administered defined bacterial consortium candidate that is being
developed for the prevention of rCDI. The RESTORATiVE303 trial is
evaluating the efficacy and safety of VE303 in patients with rCDI
and is intended to form the basis for a BLA to be filed with the
FDA. Vedanta announced that topline data are expected in 2026. In
April 2024, Vedanta was awarded $3.9 million from CARB-X to advance
Vedanta's VE707 preclinical development program for reducing
colonization and preventing subsequent infections caused by
multidrug-resistant organisms. Vedanta expects the initiation of a
Phase 1 trial in 2025. Vedanta also progressed its Phase 2
COLLECTiVE202 clinical trial of VE202 for the treatment of UC, for
Vedanta anticipates topline data in 2025.
Vor has continued to develop
its platform for crafting Hematopoietic Stem Cell to enable
targeted therapies post-transplant. In January 2024, Vor announced
it had dosed the first patient in VBP301, its Phase 1/2,
multicenter, open-label, first-in-human study of
VCAR33ALLO in patients with relapsed or refractory AML
after standard-of-care transplant or a trem-cel transplant. Vor
announced that it expects to release a VCAR33ALLO
clinical trial data update in the second half of 2024. In March
2024, Vor announced that the FDA had granted Fast Track designation
and Orphan Drug designation to VCAR33ALLO. In May 2024,
Vor announced that the trem-cel clinical trial had been expanded to
include patients diagnosed with MDS. Approximately 1,250 stem cell
transplants occur annually in the US for patients with MDS and
Vor's approach represents an important advancement in potentially
transforming treatment of these blood cancers. Vor's trem-cel has
the potential to enable the use of anti-CD33 therapies in those
settings, and the company is exploring the potential use of
trem-cel in combination with targeted therapies in these
indications. Vor announced that it expects to provide a trem-cel
clinical trial data update in the second half of 2024.
Sonde has continued to
progress a voice-based artificial intelligence platform that
detects changes in the sound of voice that are linked to health
conditions - such as depression, anxiety and respiratory disease -
to provide health tracking and monitoring. In March 2024, Sonde
announced the publication of a new study that has validated the
ability of the company's mental fitness vocal biomarker platform to
reliably distinguish individuals with elevated mental health
symptoms. The four-week cohort study revealed a statistically
significant correlation between voice-based identification of
increased or decreased mental health risk with the results of the
M3 Checklist, a clinically validated mental health assessment. In
the July post-period, Sonde launched Sonde Cognitive Fitness, which
analyzes eight vocal characteristics from 30-second voice
interactions to provide insight into one's cognitive state, helping
people manage their mental well-being and productivity
effectively.
Entrega has continued to
progress its technology platform to enable the oral administration
of biologics, vaccines and other drugs that are otherwise not
efficiently absorbed when taken orally. Entrega's innovative
approach uses a proprietary, customizable hydrogel dosage form to
control local fluid microenvironments in the gastrointestinal tract
in an effort to both enhance absorption and reduce the variability
of drug exposure. Entrega has generated preclinical
proof-of-concept data demonstrating administration of therapeutic
peptides into the bloodstream of large animals.
In May 2024, Akili
and Virtual Therapeutics, a company focused on
improving mental health at scale using engaging, immersive games,
announced the signing of a definitive merger agreement to form a
diversified, leading digital health company. The merger closed in
the July 2024 post-period, and Akili is now a wholly owned
subsidiary of Virtual Therapeutics.
Cautionary Note Regarding Forward-Looking
Statements
This Interim Management Report
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. We intend such
forward-looking statements to be covered by the safe harbor
provisions for forward looking statements contained in Section 27A
of the U.S. Securities Act of 1933, as amended and Section 21E of
the Exchange Act of 1934, as amended. All statements contained in
this Interim Management Report that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation, statements that relate to our and our
Founded Entities' therapeutic candidates, operational plans, future
prospects, objectives, developments and, strategies and
expectations, the progress and timing of clinical trials and data
readouts, our intentions for the advancement of LYT-100 and its
potential to treat IPF, our expectations as to potential earnings
based on KarXT's future regulatory and commercial milestones, our
expectations as to the achievement of clinical milestones across
our Founded Entity program, the maintenance of our cash runway, and
our commitment to realizing long-term value for our shareholders.
These forward-looking statements are based on the Company's current
expectations and are subject to known and unknown risks,
uncertainties and other important factors that could cause actual
results, performance and achievements to differ materially from
current expectations, including, but not limited to, the following:
our history of incurring significant operating losses since our
inception; our ability to realize value from our Founded Entities;
our need for additional funding to achieve our business goals,
which may not be available and which may force us to delay, limit
or terminate certain of our therapeutic development efforts; our
limited information about and limited control or influence over our
Non-Controlled Founded Entities; the lengthy and expensive process
of preclinical and clinical drug development, which has an
uncertain outcome and potential for substantial delays; potential
difficulties with enrolling patients in clinical trials, which
could delay our clinical development activities; side effects,
adverse events or other safety risks which could be associated with
our therapeutic candidates and delay or halt their clinical
development; our ability to obtain regulatory approval for and
commercialize our therapeutic candidates; our ability to compete
with companies currently marketing or engaged in the development of
treatments for indications within our programs are designed to
target; our ability to realize the benefits of our collaborations,
licenses and other arrangements; the impact of government laws and
regulations; our ability to maintain and protect our intellectual
property rights; our reliance on third parties, including clinical
research organizations, clinical investigators and manufacturers;
our vulnerability to natural disasters, global economic factors,
geo-political actions and unexpected events; and the risks,
uncertainties and other important factors described under the
caption "Risk Factors" in our Annual Report on Form 20-F for the
year ended December 31, 2023 filed with the SEC and in our other
regulatory filings. These forward-looking statements are based on
assumptions regarding the present and future business strategies of
the Company and the environment in which it will operate in the
future. Each forward-looking statement speaks only as at the date
of this Interim Management Report. Except as required by law
and regulatory requirements, we disclaim any obligation to update
or revise these forward-looking statements, whether as a result of
new information, future events or otherwise.
1. Fisher, M.,
Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson,
P., & Maher, T. M. (2017). Predicting Life Expectancy for
Pirfenidone in Idiopathic Pulmonary Fibrosis. Journal of Managed
Care & Specialty Pharmacy, 23(3-b Suppl), S17 -S24.
https://doi.org/10.18553/jmcp.2017.23.3-b.s17
2 Dempsey, T.,
Payne, S. C., Sangaralingham, L. R., Yao, X., Shah, N., &
Limper, A. H. (2021). Adoption of the Antifibrotic Medications
Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary
Fibrosis. Annals of the American Thoracic Society, 18(7),
1121-1128. https://doi.org/10.1513/annalsats.202007-901oc
3. Roche 2022
Annual Report and Boehringer Ingelheim 2022 Financial
Results
Financial Review
Reporting Framework
You should read the following
discussion and analysis together with our Condensed Consolidated
Financial Statements, including the notes thereto, set forth
elsewhere in this report. Some of the information contained in this
discussion and analysis or set forth elsewhere in this report,
including information with respect to our plans and strategy for
our business and financing our business, includes forward-looking
statements that involve risks and uncertainties. You should read
this discussion and analysis in conjunction with the risks
identified in the "Risk Factor Annex" on pages 186 to 223 of our
"Annual Report and Accounts 2023", also included as Exhibit 15.1 to
the Form 20-F for the fiscal year ended December 31, 2023 filed
with the Securities and Exchange Commission on April 25, 2024. As a
result of many factors, our actual results could differ materially
from the results described in or implied by these forward-looking
statements.
Our unaudited Condensed
Consolidated Financial Statements as of June 30, 2024, and for the
six months ended June 30, 2024 and 2023, have been prepared in
accordance with International Accounting Standard ("IAS") 34
Interim Financial
Reporting as adopted for use in the UK and also comply fully
with IAS 34 as issued by the International Accounting Standards
Board ("IASB"). This report should be read in conjunction with the
Group's 2023 Annual Reports and Accounts as of and for the year
ended December 31, 2023.
The following discussion contains
references to the Consolidated Financial Statements of PureTech
Health plc (the "Parent") and its consolidated subsidiaries,
together "the Group". These financial statements consolidate
PureTech Health plc's subsidiaries and include the Group's interest
in associates by way of equity method, as well as investments held
at fair value. Subsidiaries are those entities over which the Group
maintains control. Associates are those entities in which the Group
does not have control for financial accounting purposes but
maintains significant influence over financial and operating
policies. Where the Group has neither control nor significant
influence for financial accounting purposes, or when the investment
in associates is not in instruments that would be considered equity
for accounting purposes, we recognize our holdings in such entity
as an investment at fair value with changes in fair value being
recorded in the Condensed Consolidated Statement of Comprehensive
Income/(Loss). For purposes of our Condensed Consolidated Financial
Statements, each of our Founded Entities1 are considered
to be either a "subsidiary", an "associate" or an "investment held
at fair value" depending on whether the Group controls or maintains
significant influence over the financial and operating policies of
the respective entity at the respective period end date, and
depending on the form of the investment. For additional information
regarding the accounting treatment of these entities, see
Note 1. Material Accounting Policies to our Consolidated Financial Statements included in our 2023
Annual Report and Accounts. For additional information regarding
our operating structure, see "Basis of Presentation and
Consolidation" below.
Business Background and Results Overview
The business background is
discussed above in the Interim Management Report, which describes
the business development of our Wholly-Owned Programs2
and Founded Entities.
Our ability to generate product
revenue sufficient to achieve profitability will depend on the
successful development and eventual commercialization of one or
more therapeutic candidates of our wholly-owned or Controlled
Founded Entities3, which may or may not occur.
Historically, certain of our Founded Entities therapeutics received
marketing authorization from the FDA, but our Wholly-Owned Programs
have not generated revenue from product sales to date.
Furthermore, our ability to achieve
profitability will largely rely on successfully monetizing our
investment in Founded Entities, including the sale of rights to
royalties, entering into strategic partnerships, and other related
business development activities.
We deconsolidated a number of our
Founded Entities, specifically Vedanta Biosciences, Inc.
("Vedanta") in March 2023, Sonde Health Inc. ("Sonde") in 2022,
Karuna Therapeutics, Inc. ("Karuna"), Vor Biopharma Inc. ("Vor")
and Gelesis in 2019, and Akili in 2018.
Any deconsolidation affects our
financials in the following manner:
• our ownership interest does not provide
us with a controlling financial interest;
• we no longer control the Founded
Entity's assets and liabilities, and as a result, we derecognize
the assets, liabilities and non-controlling interests related to
the Founded Entity from our financial statements;
• we record our retained investment in the
Founded Entity at fair value; and
• the resulting amount of any gain or loss
is recognized.
We anticipate our expenses to
continue to increase proportionally in connection with execution of
our strategy around creating and supporting Founded Entities, as
well as the ongoing development activities related mostly to the
advancement into late-stage studies of the clinical programs within
our Wholly-Owned Programs. We also expect that our expenses and
capital requirements will increase in the near to mid-term as
we:
• continue our research and development
efforts;
• seek regulatory approvals for any
therapeutic candidates that successfully complete clinical trials;
and
• add clinical, scientific, operational,
financial and management information systems and personnel,
including personnel to support our therapeutic development and
potential future commercialization claims.
More specifically, we anticipate
that our internal research and development spend will increase in
the foreseeable future as we may initiate additional clinical
studies for our existing therapeutic candidates, evaluate new
therapeutic candidates for investment and further development,
progress additional therapeutic candidates into the clinic, as well
as advance our technology platforms.
1. Founded
Entities are comprised of the entities which the Company
incorporated and announced the incorporation as a Founded Entity
externally. It includes certain of the Company's wholly-owned
subsidiaries which have been announced by the Company as Founded
Entities, Controlled Founded Entities3 and
deconsolidated Founded Entities. As of June 30, 2024,
deconsolidated Founded Entities included Akili Interactive Labs,
Inc., Karuna Therapeutics, Inc., Vor Bio, Inc., Gelesis, Inc.,
Sonde Health, Inc., and Vedanta Biosciences, Inc.
2.
Wholly-Owned Programs are comprised of the Company's current and
future therapeutic candidates and technologies that are developed
by the Company's wholly-owned subsidiaries, whether they were
announced as a Founded Entity or not, and will be advanced through
with either the Company's funding or non-dilutive sources of
financing. As of June 30 ,2024, Wholly-Owned Programs were
developed by the wholly-owned subsidiaries including PureTech LYT,
Inc., PureTech LYT 100, Inc. and Gallop Oncology, Inc. and included
primarily the programs LYT-100, and LYT-200.
3.
Controlled Founded Entities are comprised of the Company's
consolidated operational subsidiaries that currently have already
raised third-party dilutive capital. As of June 30, 2024,
Controlled Founded Entities included Entrega, Inc. and Seaport
Therapeutics.
In addition, with respect to our
Founded Entities' programs, we anticipate that we will continue to
fund a small portion of development costs by strategically
participating in such companies' financings when we believe
participation in such financings is in the best interests of our
shareholders. The form of any such participation may include
investment in public or private financings, collaboration,
partnership arrangements, and/or licensing arrangements, among
others. Our management and strategic decision makers consider the
future funding needs of our Founded Entities and evaluate the needs
and opportunities for returns with respect to each of these Founded
Entities routinely and on a case-by-case basis.
As a result, we may need
substantial additional funding in the future, following the period
described below in the Funding Requirement section, to support our
continuing operations and pursue our growth strategy until such
time as we can generate sufficient revenue from product sales to
support our operations, if ever. Until such time, we expect to
finance our operations through a combination of monetization of our
interests in our Founded Entities, collaborations with third
parties, or other sources. We may be unable to raise additional
funds or enter into such other agreements or arrangements when
needed on favorable terms, or at all. If we are unable to raise
capital or enter into such agreements, as and when needed, we may
have to delay, scale back or discontinue the development and
commercialization of one or more of our wholly-owned therapeutic
candidates.
Measuring Performance
The Financial Review discusses our
operating and financial performance, our cash flows and liquidity
as well as our financial position and our resources. The results of
current period are compared with the results of the comparative
period in the prior year.
Reported Performance
Reported performance considers all
factors that have affected the results of our business, as
reflected in our Condensed Consolidated Financial
Statements.
Core Performance
Core performance measures are
alternative performance measures which are adjusted and non-IFRS
measures. These measures cannot be derived directly from our
Condensed Consolidated Financial Statements. We believe that these
non-IFRS performance measures, when provided in combination with
reported performance, will provide investors, analysts and other
stakeholders with helpful complementary information to better
understand our financial performance and our financial position
from period to period. The measures are also used by management for
planning and reporting purposes. The measures are not substitutable
for IFRS financial information and should not be considered
superior to financial information presented in accordance with
IFRS.
Cash flow and liquidity
|
|
PureTech Level cash, cash
equivalents and short-term investments
|
Measure type: Core
performance
|
Definition: Cash and cash
equivalents and short-term investments held at PureTech Health plc
and our wholly-owned subsidiaries.
|
|
Why we use it: PureTech Level
cash, cash equivalents and short-term investments is a measure that
provides valuable additional information with respect to cash, cash
equivalents and short-term investments available to fund the
Wholly-Owned Programs and make certain investments in Founded
Entities.
|
Recent Developments (subsequent to June 30,
2024)
The Group has evaluated subsequent
events after June 30, 2024 up to the date of issuance,
August 28, 2024, of the Condensed Consolidated Financial
Statements, and has not identified any recordable or disclosable
events not otherwise reported in these unaudited Condensed
Consolidated Financial Statements or notes thereto.
Financial Highlights
The following is the reconciliation
of the amounts appearing in our Condensed Consolidated Statement of
Financial Position to the non-IFRS alternative performance measure
described above:
(in thousands)
|
June 30
2024
|
December
31, 2023
|
Cash and cash
equivalents
|
308,478
|
191,081
|
Short-term investments
|
191,938
|
136,062
|
Consolidated cash, cash equivalents and short-term
investments
|
500,416
|
327,143
|
Less: cash and cash equivalents held at non-wholly owned
subsidiaries
|
(99,778)
|
(1,097)
|
PureTech Level cash, cash equivalents and short-term
investments
|
$400,638
|
$326,046
|
Basis of Presentation and Consolidation
Our Condensed Consolidated
Financial Statements consolidate the financial information of
PureTech Health plc, as well as its subsidiaries, and include our
interest in associates and investments held at fair value, and are
reported in reportable segments as described below.
Basis for Segmentation
Our Directors are our strategic
decision-makers. Our operating segments are determined based on the
financial information provided to our Directors periodically for
the purposes of allocating resources and assessing
performance. We have determined each of our Wholly-Owned
Programs represents an operating segment, and we have aggregated
each of these operating segments into one reportable segment, the
Wholly-Owned Programs segment. Each of our Controlled Founded
Entities represents an operating segment. We aggregate each
Controlled Founded Entity operating segment into one reportable
segment, the Controlled Founded Entities segment. The aggregation
is based on the high level of operational and financial
similarities of the operating segments. For our entities that do
not meet the definition of an operating segment, we present this
information in the Parent Company and Other column in our segment
footnote to reconcile the information in the segment discussion to
our Condensed Consolidated Financial Statements. Substantially all
of our revenue and profit generating activities are generated
within the United States and, accordingly, no geographical
disclosures are provided.
There was no change to the
reportable segments in 2024, except for the changes to the
composition of the reportable segments as described
below.
In January 2024, we launched two
new Founded Entities (Seaport Therapeutics "Seaport" and Gallop
Oncology "Gallop") to advance certain programs within the
Wholly-Owned Programs segment. The financial results of these
programs were included in the Wholly-Owned Programs segment as of
and for the year ended December 31, 2023. Upon raising dilutive
third-party financing in April 2024, the financial results of
Seaport are included within the Controlled Founded Entities segment
as the Group still maintains control over this entity. As of June
30, 2024, Alivio became dormant and did not meet the definition of
operating segment. The financial results of this entity were
removed from the Wholly-Owned Programs segment and are included in
the Parent Company and Other column. The corresponding information
for 2023 has been restated to include Alivio in the Parent Company
and Other column, so that the segment disclosures are presented on
a comparable basis.
Results of Operations
The following table, which has been
derived from our unaudited financial statements for the six months
ended June 30, 2024 and 2023, included herein, summarizes our
results of operations for the periods indicated, together with the
changes in those items:
|
Six
Months Ended June 30,
|
(in thousands)
|
2024
|
2023
|
Change
(2023 to
2024)
|
Contract revenue
|
$-
|
$750
|
$(750)
|
Grant revenue
|
288
|
2,400
|
(2,112)
|
Total revenue
|
288
|
3,150
|
(2,862)
|
Operating expenses:
|
|
|
|
General and administrative
expenses
|
(27,758)
|
(26,166)
|
(1,592)
|
Research and development
expenses
|
(38,928)
|
(53,146)
|
14,218
|
Operating income/(loss)
|
(66,398)
|
(76,163)
|
9,765
|
Other income/(expense):
|
|
|
|
Gain/(loss) on deconsolidation of
subsidiary
|
-
|
61,787
|
(61,787)
|
Gain/(loss) on investments held at
fair value
|
3,882
|
7,818
|
(3,936)
|
Realized gain/(loss) on sale of
investments
|
151
|
-
|
151
|
Gain/(loss) on investments in notes
from associates
|
11,612
|
(6,045)
|
17,657
|
Other income/(expense)
|
548
|
(1,134)
|
1,682
|
Other income/(expense)
|
16,193
|
62,426
|
(46,233)
|
Net finance income/(costs)
|
(1,468)
|
5,316
|
(6,784)
|
Share of net income/(loss) of
associates accounted for using the equity method
|
(3,357)
|
(5,324)
|
1,967
|
Income/(loss) before income taxes
|
(55,030)
|
(13,744)
|
(41,286)
|
Tax benefit/(expense)
|
6,147
|
(11,807)
|
17,953
|
Net income/(loss) including non-controlling
interest
|
(48,883)
|
(25,551)
|
(23,333)
|
Net income/(loss) attributable to the Owners of the
Group
|
$(41,773)
|
$(25,004)
|
$(16,768)
|
Comparison of the Six Months Ended June 30, 2024 and
2023
Total Revenue
|
Six
Months Ended June 30,
|
(in thousands)
|
2024
|
2023
|
Change
|
Contract Revenue:
|
|
|
|
Controlled Founded
Entities
|
$-
|
$750
|
$(750)
|
Total Contract Revenue
|
-
|
750
|
(750)
|
Grant Revenue:
|
|
|
|
Wholly-Owned Programs
|
288
|
135
|
153
|
Parent Company and Other
|
-
|
2,265
|
(2,265)
|
Total Grant Revenue
|
288
|
2,400
|
(2,112)
|
Total Revenue
|
$288
|
$3,150
|
$(2,862)
|
Our total revenue was
$0.3 million for the six months ended June 30, 2024, a
decrease of $2.9 million, or 91 percent compared to the six
months ended June 30, 2023. The decrease in revenue was primarily
due to the $2.3 million reduction in Parent Company and Other
revenue which was mostly a result of the deconsolidation of Vedanta
from our financial statements in March 2023, as well as
$0.7 million reduction due to the completion of a revenue
agreement for Entrega, one of our Controlled Founded
Entities.
Research and Development
Expenses
|
Six
Months Ended June 30,
|
(in thousands)
|
2024
|
2023
|
Change
|
Research and Development
Expenses:
|
|
|
|
Wholly-Owned Programs
|
$(32,981)
|
$(45,139)
|
$(12,158)
|
Controlled Founded
Entities
|
(5,710)
|
(368)
|
5,342
|
Parent Company and Other
|
(237)
|
(7,640)
|
(7,403)
|
Total Research and Development Expenses:
|
$(38,928)
|
$(53,146)
|
$(14,218)
|
Our research and development
expenses were $38.9 million for the six months ended June 30,
2024, a decrease of $14.2 million, or 27 percent compared to
the six months ended June 30, 2023. The decrease in research and
development expenses was driven by 1) our reduced spending on
clinical and CMC activities related to our wholly-owned programs
due to the prioritization of research and development projects,
whereby the Group elected to focus on programs where it believes it
has the highest probability of success and reduced efforts in
research and clinical stage projects where such probability of
success is lower, 2) the decrease in employee related costs from
lower headcount; and 3) the deconsolidation of Vedanta in March
2023 which resulted in us no longer including Vedanta's research
and development expenses in our Condensed Consolidated Financial
Statements.
Wholly-Owned Programs: a decrease
of $12.2 million in research and development expenses.
$9.2 million of the decrease was due to 1) transfer of GLYPH
platform, the related clinical programs and employees to Seaport,
the expense of which is included in Controlled Founded Entities; 2)
the prioritization of research and development projects as
discussed above; and 3) the decrease in employee related costs from
lower headcount. The remaining decrease was due to a
$1.0 million decrease in asset impairment costs, a
$0.6 million decrease in depreciation expense and a
$1.4 million decrease in legal and consulting services in the
six months ended June 30, 2024.
Controlled Founded Entities:
an increase of $5.3 million in research and
development expense due to the transfer of GLYPH platform, the related clinical programs and employees to
Seaport.
Parent Company and Other: a
decrease of $7.4 million due to the deconsolidation of Vedanta
in March 2023, and the winding down of the Alivio
program and the entity became dormant as of June 30,
2024.
General and Administrative
Expenses
|
Six
Months Ended June 30,
|
(in thousands)
|
2024
|
2023
|
Change
|
General and Administrative
Expenses:
|
|
|
|
Wholly-Owned Programs
|
$(4,450)
|
$(6,981)
|
$(2,531)
|
Controlled Founded
Entities
|
(6,548)
|
(237)
|
6,311
|
Parent Company and Other
|
(16,759)
|
(18,947)
|
(2,188)
|
Total General and Administrative Expenses
|
$(27,758)
|
$(26,166)
|
$1,592
|
Our general and administrative
expenses were $27.8 million for the six months ended June 30,
2024, an increase of $1.6 million, or 6 percent compared to
the six months ended June 30, 2023. The increase was primarily due
to a $4.0 million increase in stock
based compensation largely resulting from stock awards granted to
Seaport employees, offset by a $2.9 million decrease from the
deconsolidation of Vedanta in March 2023.
Wholly-Owned Programs: a decrease
of $2.5 million in general and administrative expenses was
primarily driven by a decrease of $2.0 million in management
fees charged by the parent company.
Controlled Founded Entity: an
increase of $6.3 million in general and administrative
expenses was primarily driven by the establishment and operation of
Seaport including a $1.6 million increase in legal and
advisory fees, $3.2 million increase in stock based
compensation expense and a $1.3 million increase in
payroll.
Parent Company and Other: a
$2.2 million decrease in general and administrative expenses
was primarily attributable to a $2.9 million decrease due to
the deconsolidation of Vedanta in March 2023, a $1.5 million
decrease in legal advisory costs primarily related to Gelesis notes
and Merger Agreement in 2023, partially offset by a
$2.2 million increase in management fee.
Total Other
Income/(Expense)
Total other income was
$16.2 million for the six months ended June 30, 2024 compared
to $62.4 million for the six months ended June 30, 2023, a
decrease of $46.2 million, or 74 percent. The decrease in
other income was primarily attributable to the
following:
• one time gain of
$61.8 million recognized in 2023 as a result of the
deconsolidation of Vedanta in March 2023, reflecting a decrease in
other income of $61.8 million.
• a gain of $11.6 million in
investments in notes from associates for the six months ended June
30, 2024 compared to a loss of $6.0 million for the six months
ended June 30, 2023, reflecting an increase in other income of
$17.7 million.
Net Finance
Income/(Costs)
Net finance costs was
$1.5 million for the six months ended June 30, 2024, compared
to net finance income of $5.3 million for the six months ended
June 30, 2023, an increase in net finance cost of $6.8 million
or 128 percent. The increase was primarily attributable to the
following:
• an increase in non-cash interest
expense of $6.8 million related to the sale of future
royalties liability due to the six months' accretion of the
liability as well as the change to the liability based on the
updated cash flow forecast in the six months ended June 30, 2024 as
compared to the four months' accretion of the liability for the six
months ended June 30, 2023.
• an increase in finance costs of
$4.3 million related to changes in the fair value of subsidiary
preferred share liabilities: an income of $2.6 million for the
reduction in fair value of Vedanta and Follica preferred share
liability for the six months ended June 30, 2023 compared to an
expense of $1.6 million for the increase in fair value of
Seaport preferred share liability for the six months ended June 30,
2024.
The above increases in finance
costs were partially offset by an increase in interest income of
$4.0 million for the six months ended June 30, 2024 due to
increased cash and cash equivalent and short-term investment
balances as well as higher interest rates earned for the
period.
Share of Net Income/(Loss) of
Associates Accounted for Using the Equity Method
For the six months ended June 30,
2024, the share in net loss of associates reported under the equity
method was $3.4 million as compared to the share in net loss
of associates of $5.3 million for the six months ended June
30, 2023, a decrease in loss of $2.0 million or 37 percent.
The decrease was primarily attributable to a decrease in Gelesis
losses as it went bankrupt in October 2023 and the carrying value
of our investment in Gelesis was reduced to zero as of December 31,
2023.
Taxation
For the six months ended June 30,
2024, the income tax benefit was $6.1 million, compared to an
income tax expense of $11.8 million for the six months ended
June 30, 2023. The decrease in income tax expense was primarily due
to recording an income tax benefit for the six months ended June
30, 2024, related to generated tax credits, recognizing a capital
loss from the Akili investment, partially offset by a discrete
income tax expense related to the market-to-market investment
adjustments, compared to the recording of an income tax expense in
the six months ended June 30, 2023 due to nonrecurring events of
the sale of future royalties to Royalty Pharma, partially offset by
the deconsolidation of Vedanta.
Material Accounting Policies and Significant Judgments and
Estimates
Our financial review of the
financial condition and results of operations is based on our
interim financial statements, which we have prepared in accordance
with International Accounting Standards ("IAS") 34 Interim Financial Reporting as
adopted for use in the UK and also comply fully with IAS 34 as
issued by the International Accounting Standards Board ("IASB"). In
the preparation of these financial statements, we are required to
make judgments, estimates and assumptions about the carrying
amounts of assets and liabilities that are not readily apparent
from other sources. The estimates and associated assumptions are
based on historical experience and other factors that are
considered to be relevant. Actual results may differ from these
estimates under different assumptions or conditions.
Our estimates and assumptions are
reviewed on an ongoing basis. Revisions to accounting estimates are
recognized in the period in which the estimate is revised if the
revision affects only that period or in the period of the revisions
and future periods if the revision affects both current and future
periods.
The accounting policies most
critical to the judgments and estimates used in the preparation of
our financial statements have not changed from those disclosed in
Note 1, Material Accounting policies of the accompanying notes to
the Consolidated Financial Statements included in our 2023 Annual
Report and Accounts except for the adoption of new and amended IFRS
Accounting Standards as set out in Note 2. New Standards and
Interpretations to our Condensed Consolidated Financial
Statements.
Cash Flow and Liquidity
Our cash flows may fluctuate and
are difficult to forecast and will depend on many factors,
including:
• the expenses incurred in the
development of wholly-owned and Controlled Founded Entity
therapeutic candidates;
• the revenue, if any, generated by
wholly-owned and Controlled-Founded Entity therapeutic
candidates;
• the revenue, if any, generated
from licensing and royalty agreements with Founded Entities;
• the financing requirements of the
Wholly-Owned Programs and our Founded Entities;
• the investing activities including
the monetization, through sale, of shares held in our public
Founded Entities; and
• repurchases of our shares
As of June 30, 2024, we had
consolidated cash and cash equivalents of $308.5 million and
short term investments of $191.9 million. As of June 30, 2024,
we had PureTech Level cash, cash equivalents and short-term
investments of $400.6 million. PureTech Level cash, cash
equivalents and short term investments is a non-IFRS measure (for a
definition of PureTech Level cash, cash equivalents and short term
investments and a reconciliation to the IFRS number, see the
section Measuring Performance earlier in this Financial
review).
Cash Flows
The following table summarizes our
cash flows for each of the periods presented:
|
Six
Months Ended June 30,
|
(in thousands)
|
2024
|
2023
|
Change
|
Net cash used in operating
activities
|
$(80,014)
|
$(65,133)
|
$(14,881)
|
Net cash provided by investing
activities
|
236,512
|
173,885
|
62,627
|
Net cash provided by (used in)
financing activities
|
(39,101)
|
91,897
|
(130,998)
|
Net increase (decrease) in cash and cash
equivalents
|
$117,397
|
$200,649
|
$(83,252)
|
Operating Activities
Net cash used in operating
activities was $80.0 million for the six months ended June 30,
2024, as compared to $65.1 million for the six months ended June
30, 2023, an increase of $14.9 million in net cash used in
operating activities. The increase in cash outflows is primarily
attributable to $15.1 million increase in estimated tax payments
related to the sale of the Karuna shares and $19.0 million
change in operating assets and liabilities including $10.8 million
change in operating assets largely related to accounts receivable
and $8.2 million change in operating liabilities due to the timing
of payments in the normal course of business, partially offset by
$9.8 million decrease in operating loss and $7.2 million increase
in cash receipts from interest income.
Investing Activities
Net cash provided by investing
activities was $236.5 million for the six months ended June 30,
2024, as compared to net cash provided by investing activities of
$173.9 million for the six months ended June 30, 2023, an increase
of $62.6 million in net cash provided by investing
activities.
The increase in the net cash inflow
was primarily attributed to the $292.7 million proceeds received
from the sale of Karuna shares in 2024, and two investing cash
outflows in 2023 that did not occur in 2024 ($15.4 million
investments in subsidiary notes, $13.8 million cash deduction from
the deconsolidation of Vedanta) partially offset by increased cash
outflow from short-term investment activities (redemptions, net of
purchases) amounting to $258.8 million.
Financing Activities
Net cash used by financing
activities was $39.1 million for the six months ended June 30,
2024, as compared to net cash provided by financing activities of
$91.9 million for the six months ended June 30, 2023, a decrease of
$131.0 million in net cash from financing activities. The decrease
in net cash from financing activities was primarily attributable to
$100.0 million received during the six months ended June 30, 2023
in respect of the sale of future Karuna royalties, and no such
proceeds received during the six months ended June 30, 2024. The
decrease is further attributable to the $101.6 million cash used
for the purchase of shares in connection with the Tender Offer (see
note 10. Equity). The decreases were partially offset by an
increase of $68.1 million proceeds received from the sale of
preferred shares of Seaport.
Funding Requirements
We have incurred operating losses
since inception. Based on our current plans, we believe our
existing financial assets as of June 30, 2024 will be sufficient to
fund our operations and capital expenditure requirements for at
least three years. We expect to incur substantial additional
expenditures in the near term to support our ongoing and future
activities. We anticipate we will continue to incur net operating
losses for the foreseeable future to support our existing Founded
Entities and newly launched Founded Entities (Seaport Therapeutics
and Gallop Oncology), and our strategy around creating and
supporting other Founded Entities, should they require it, to reach
significant development milestones over the period of the
assessment in conjunction with our external partners. We also
expect to incur significant costs to advance our Wholly-Owned
Programs, to continue research and development efforts, to discover
and progress new therapeutic candidates and to fund the Group's
operating costs for at least three years. Our ability to fund our
therapeutic development and clinical operations as well as ability
to fund our existing, newly founded and future Founded Entities,
will depend on the amount and timing of cash received from planned
financings, monetization of shares of public Founded Entities and
potential business development activities. Our future capital
requirements will depend on many factors, including:
• the costs, timing and outcomes of
clinical trials and regulatory reviews associated with our
wholly-owned therapeutic candidates;
• the costs of preparing, filing and
prosecuting patent applications and maintaining, enforcing and
defending intellectual property related claims;
• the emergence of competing technologies
and products and other adverse marketing developments;
• the effect on our therapeutic and
product development activities of actions taken by the U.S. Food
and Drug Administration ("FDA"), the European Medicines Agency
("EMA") or other regulatory authorities;
• the number and types of future
therapeutics we develop and support with the goal of
commercialization;
• the costs, timing and outcomes of
identifying, evaluating, and investing in technologies and drug
candidates to develop as Wholly-Owned Programs or as Founded
Entities;
• the costs of commercialization
activities for any of the therapeutic candidates within our Wholly
Owned Program that receive marketing approval, including the costs
and timing of establishing therapeutic sales, marketing,
distribution and manufacturing capabilities, or entering into
strategic collaborations with third parties to leverage or access
these capabilities; and
• the success of our Founded Entities and
their need for additional capital.
A change in the outcome of any of
these or other variables with respect to the development of any of
our wholly-owned therapeutic candidates could significantly change
the costs and timing associated with the development of that
therapeutic candidate.
Further, our operating plans may
change, and we may need additional funds to meet operational needs
and capital requirements for clinical trials and other research and
development activities. We currently have no credit facility or
other committed sources of capital beyond our existing financial
assets. Because of the numerous risks and uncertainties associated
with the development and commercialization of our wholly-owned
therapeutic candidates, we have only a general estimate of the
amounts of increased capital outlays and operating expenditures
associated with our current and anticipated therapeutic development
programs and these may change in the future.
Condensed Consolidated Statement of Comprehensive
Income/(Loss) (Unaudited)
For the six months ended June 30
|
Note
|
2024
$000s
|
2023
$000s
|
Contract revenue
|
|
-
|
750
|
Grant revenue
|
|
288
|
2,400
|
Total revenue
|
|
288
|
3,150
|
Operating expenses:
|
|
|
|
General and administrative
expenses
|
|
(27,758)
|
(26,166)
|
Research and development
expenses
|
|
(38,928)
|
(53,146)
|
Operating income/(loss)
|
|
(66,398)
|
(76,163)
|
Other income/(expense):
|
|
|
|
Gain/(loss) on deconsolidation of
subsidiary
|
4
|
-
|
61,787
|
Gain/(loss) on investments held at
fair value
|
4
|
3,882
|
7,818
|
Realized gain/(loss) on sale of
investments
|
4
|
151
|
-
|
Gain/(loss) on investments in notes
from associates
|
6
|
11,612
|
(6,045)
|
Other income/(expense)
|
|
548
|
(1,134)
|
Other income/(expense)
|
|
16,193
|
62,426
|
Finance income/(costs):
|
|
|
|
Finance income
|
8
|
11,732
|
7,731
|
Finance costs -
contractual
|
8
|
(1,036)
|
(1,338)
|
Finance income/(costs) - fair value
accounting
|
8
|
(1,613)
|
2,650
|
Finance costs - non cash interest
expense related to sale of future royalties
|
12
|
(10,551)
|
(3,726)
|
Net finance income/(costs)
|
|
(1,468)
|
5,316
|
Share of net income/(loss) of
associates accounted for using the equity method
|
5
|
(3,357)
|
(5,324)
|
Income/(loss) before taxes
|
|
(55,030)
|
(13,744)
|
Tax benefit/(expense)
|
18
|
6,147
|
(11,807)
|
Income/(loss) for the period
|
|
(48,883)
|
(25,551)
|
Other comprehensive income/(loss):
|
|
|
|
Items that are or may be
reclassified as profit or loss
|
|
|
|
Equity-accounted associate - share
of other comprehensive income (loss)
|
|
-
|
92
|
Total other comprehensive
income/(loss)
|
|
-
|
92
|
Total comprehensive income/(loss) for the
period
|
|
(48,883)
|
(25,458)
|
Income/(loss) attributable to:
|
|
|
|
Owners of the Group
|
|
(41,773)
|
(25,004)
|
Non-controlling
interests
|
|
(7,111)
|
(546)
|
|
|
(48,883)
|
(25,551)
|
Comprehensive income/(loss) attributable to:
|
|
|
|
Owners of the Group
|
|
(41,773)
|
(24,912)
|
Non-controlling
interests
|
|
(7,111)
|
(546)
|
|
|
(48,883)
|
(25,458)
|
|
|
$
|
$
|
Earnings/(loss) per share:
|
|
|
|
Basic earnings/(loss) per
share
|
9
|
(0.15)
|
(0.09)
|
Diluted earnings/(loss) per
share
|
9
|
(0.15)
|
(0.09)
|
The accompanying notes are an
integral part of these financial statements.
Condensed Consolidated Statement of Financial Position
(Unaudited)
As
of
|
Note
|
June 30,
2024
$000s
|
December
31, 2023
$000s
|
Assets
|
|
|
|
Non-current assets
|
|
|
|
Property and equipment,
net
|
|
8,393
|
9,536
|
Right of use asset, net
|
|
8,943
|
9,825
|
Intangible assets, net
|
|
906
|
906
|
Investments held at fair
value
|
4
|
29,030
|
317,841
|
Investment in associates - equity
method
|
5
|
-
|
3,185
|
Investments in notes from
associates
|
6
|
16,212
|
4,600
|
Deferred tax assets
|
|
6,778
|
-
|
Other non-current assets
|
|
878
|
878
|
Total non-current assets
|
|
71,140
|
346,771
|
Current assets
|
|
|
|
Trade and other
receivables
|
|
2,055
|
2,376
|
Income tax receivable
|
|
-
|
11,746
|
Prepaid expenses
|
|
4,703
|
4,309
|
Other financial assets
|
|
1,636
|
1,628
|
Short-term investments
|
|
191,938
|
136,062
|
Cash and cash
equivalents
|
|
308,478
|
191,081
|
Total current assets
|
|
508,810
|
347,201
|
Total assets
|
|
579,950
|
693,973
|
Equity and liabilities
|
|
|
|
Equity
|
|
|
|
Share capital
|
|
4,860
|
5,461
|
Share premium
|
|
290,262
|
290,262
|
Treasury stock
|
|
(46,892)
|
(44,626)
|
Merger reserve
|
|
138,506
|
138,506
|
Translation reserve
|
|
182
|
182
|
Other reserve
|
10
|
(8,541)
|
(9,538)
|
(Accumulated deficit)/Retained
earnings
|
|
(62,510)
|
83,820
|
Equity attributable to the owners of the
Group
|
|
315,867
|
464,066
|
Non-controlling
interests
|
14
|
(9,661)
|
(5,835)
|
Total equity
|
|
306,206
|
458,232
|
Non-current liabilities
|
|
|
|
Sale of future royalties liability,
non-current
|
12
|
117,458
|
110,159
|
Deferred tax liability
|
|
-
|
52,462
|
Lease liability,
non-current
|
|
16,422
|
18,250
|
Liability for share-based
awards
|
7
|
1,550
|
3,501
|
Total non-current
liabilities
|
|
135,430
|
184,371
|
Current liabilities
|
|
|
|
Lease liability, current
|
|
3,574
|
3,394
|
Trade and other payables
|
15
|
31,445
|
44,107
|
Sale of future royalties liability,
current
|
12
|
3,252
|
-
|
Income taxes payable
|
|
26,135
|
-
|
Subsidiary:
|
|
|
|
Notes payable
|
|
4,027
|
3,699
|
Preferred shares
|
11,
13
|
69,882
|
169
|
Total current
liabilities
|
|
138,314
|
51,370
|
Total liabilities
|
|
273,744
|
235,741
|
Total equity and liabilities
|
|
579,950
|
693,973
|
Please refer to the accompanying
Notes to the consolidated financial information. Registered number:
09582467.
The Consolidated Financial Statements were approved by the Board of
Directors and authorized for issuance on August 28, 2024 and
signed on its behalf by:
Bharatt Chowrira
Chief Executive Officer
August 28, 2024
The accompanying notes are an
integral part of these financial statements.
Condensed Consolidated Statement of Changes in Equity
(Unaudited)
For the six months ended June 30
|
|
Share
Capital
|
|
Treasury
Shares
|
|
|
|
|
|
|
|
|
Note
|
Shares
|
Amount
$000s
|
Share
premium
$000s
|
Shares
|
Amount
$000s
|
Merger
reserve $000s
|
Translation reserve
$000s
|
Other
reserve
$000s
|
Retained
earnings/ (accumulated deficit)
$000s
|
Total
Parent equity
$000s
|
Non-controlling interests
$000s
|
Total
Equity
$000s
|
Balance January 1, 2023
|
|
289,161,653
|
5,455
|
289,624
|
(10,595,347)
|
(26,492)
|
138,506
|
89
|
(14,478)
|
149,516
|
542,220
|
5,369
|
547,589
|
Net income/(loss)
|
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(25,004)
|
(25,004)
|
(546)
|
(25,551)
|
Other comprehensive income/(loss)
for the period
|
|
-
|
-
|
-
|
|
|
-
|
92
|
-
|
-
|
92
|
-
|
92
|
Total comprehensive income/(loss) for the
period
|
|
-
|
-
|
-
|
-
|
-
|
-
|
92
|
-
|
(25,004)
|
(24,912)
|
(546)
|
(25,458)
|
Deconsolidation of
Subsidiary
|
4
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(9,085)
|
(9,085)
|
Exercise of stock
options
|
7
|
306,506
|
6
|
638
|
149,226
|
327
|
-
|
-
|
(10)
|
-
|
961
|
-
|
961
|
Purchase of Treasury
stock
|
10
|
-
|
-
|
-
|
(2,510,887)
|
(7,276)
|
-
|
-
|
-
|
-
|
(7,276)
|
-
|
(7,276)
|
Equity-settled share-based
awards
|
7
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1,465
|
-
|
1,465
|
277
|
1,742
|
Settlement of restricted stock
units
|
7
|
-
|
-
|
-
|
161,678
|
337
|
-
|
-
|
87
|
-
|
424
|
-
|
424
|
Expiration of share options in
subsidiary
|
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
786
|
-
|
786
|
(786)
|
-
|
Other
|
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(6)
|
(6)
|
Balance June 30, 2023
|
|
289,468,159
|
5,461
|
290,262
|
(12,795,330)
|
(33,105)
|
138,506
|
182
|
(12,149)
|
124,512
|
513,669
|
(4,778)
|
508,891
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance January 1, 2024
|
|
289,468,159
|
5,461
|
290,262
|
(17,614,428)
|
(44,626)
|
138,506
|
182
|
(9,538)
|
83,820
|
464,066
|
(5,835)
|
458,232
|
Net income/(loss)
|
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(41,773)
|
(41,773)
|
(7,111)
|
(48,883)
|
Total comprehensive income/(loss)
for the period
|
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(41,773)
|
(41,773)
|
(7,111)
|
(48,883)
|
Exercise of stock
options
|
7
|
-
|
-
|
-
|
412,729
|
1,041
|
-
|
-
|
(146)
|
-
|
895
|
-
|
895
|
Repurchase and cancellation of
ordinary shares from Tender Offer
|
10
|
(31,540,670)
|
(600)
|
-
|
-
|
-
|
-
|
-
|
600
|
(104,558)
|
(104,558)
|
-
|
(104,558)
|
Purchase of Treasury
stock
|
10
|
-
|
-
|
-
|
(1,903,990)
|
(4,819)
|
-
|
-
|
-
|
-
|
(4,819)
|
-
|
(4,819)
|
Equity-settled share-based awards
expense
|
7
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
754
|
-
|
754
|
3,285
|
4,039
|
Settlement of restricted stock
units
|
7
|
-
|
-
|
-
|
599,512
|
1,512
|
-
|
-
|
(211)
|
-
|
1,301
|
-
|
1,301
|
Expiration of share options in
subsidiary
|
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
-
|
1
|
(1)
|
-
|
Balance June 30, 2024
|
|
257,927,489
|
4,860
|
290,262
|
(18,506,177)
|
(46,892)
|
138,506
|
182
|
(8,541)
|
(62,510)
|
315,867
|
(9,661)
|
306,206
|
The accompanying notes are an
integral part of these financial statements.
Condensed Consolidated Statement of Cash Flows
(Unaudited)
For the six months ended June 30
|
Note
|
2024
$000s
|
2023
$000s
|
Cash flows from operating
activities
|
|
|
|
Income/(loss) for the
period
|
|
(48,883)
|
(25,551)
|
Adjustments to reconcile
income/(loss) for the period to net cash used in operating
activities:
|
|
|
|
Non-cash items:
|
|
|
|
Depreciation and
amortization
|
|
1,814
|
3,061
|
Share-based compensation
expense
|
7
|
4,648
|
1,256
|
(Gain)/loss on investment held at
fair value
|
4
|
(3,882)
|
(7,818)
|
Realized gain on sale of
investments
|
4
|
(151)
|
-
|
Gain on deconsolidation of
subsidiary
|
4
|
-
|
(61,787)
|
Share of net loss of associates
accounted for using the equity method
|
5
|
3,357
|
5,324
|
(Gain)/loss on investments in notes
from associates
|
6
|
(11,612)
|
6,045
|
(Gain)/loss on disposal of
assets
|
|
(23)
|
522
|
Impairment of fixed
assets
|
|
45
|
1,066
|
Income taxes, net
|
18
|
(6,147)
|
11,807
|
Finance (income)/costs,
net
|
8
|
1,468
|
(5,316)
|
Changes in operating assets and
liabilities:
|
|
|
|
Trade and other
receivables
|
|
320
|
9,243
|
Prepaid expenses
|
|
(394)
|
1,484
|
Deferred revenue
|
|
-
|
(283)
|
Trade and other payables
|
15
|
(16,883)
|
(9,318)
|
Other
|
|
-
|
964
|
Income taxes paid
|
|
(15,213)
|
(150)
|
Interest received
|
|
12,196
|
5,444
|
Interest paid
|
|
(675)
|
(1,127)
|
Net cash used in operating activities
|
|
(80,014)
|
(65,133)
|
Cash flows from investing
activities:
|
|
|
|
Purchase of property and
equipment
|
|
-
|
(70)
|
Proceeds from sale of property and
equipment
|
|
188
|
590
|
Investment in convertible notes and
warrants from associates
|
7
|
-
|
(15,350)
|
Sale of investments held at fair
value
|
4
|
292,672
|
-
|
Short-term loan to
associate
|
|
660
|
-
|
Repayment of short-term loan from
associate
|
|
(660)
|
-
|
Cash derecognized upon loss of
control over subsidiary (see table below)
|
4
|
-
|
(13,784)
|
Purchases of short-term
investments
|
|
(213,035)
|
-
|
Proceeds from maturity of
short-term investments
|
|
156,687
|
202,500
|
Net cash provided by investing activities
|
|
236,512
|
173,885
|
Cash flows from financing
activities:
|
|
|
|
Receipt of cash from sale of future
royalties
|
12
|
-
|
100,000
|
Issuance of subsidiary preferred
Shares
|
11
|
68,100
|
-
|
Payment of lease
liability
|
|
(1,648)
|
(1,764)
|
Exercise of stock
options
|
|
895
|
961
|
Repurchase of ordinary
shares
|
10
|
(101,629)
|
-
|
Purchase of treasury
stock
|
10
|
(4,819)
|
(7,276)
|
Other
|
|
-
|
(23)
|
Net cash provided by (used in) financing
activities
|
|
(39,101)
|
91,897
|
Net increase (decrease) in cash and
cash equivalents
|
|
117,397
|
200,649
|
Cash and cash equivalents at
beginning of year
|
|
191,081
|
149,866
|
Cash and cash equivalents at end of period
|
|
308,478
|
350,515
|
Supplemental disclosure of non-cash investment and financing
activities:
|
|
|
|
Purchase of intangible assets not
yet paid in cash
|
|
-
|
200
|
Repurchase of ordinary shares not
yet paid in cash
|
|
2,929
|
-
|
Settlement of restricted stock
units through issuance of equity
|
|
1,301
|
424
|
Supplemental disclosure of non-cash investment and financing
activities (continued):
Assets, Liabilities and
non-controlling interests in deconsolidated subsidiary
|
2023
$000s
|
Trade and other
receivables
|
(702)
|
Prepaid assets
|
(3,516)
|
Property, plant and equipment,
net
|
(8,092)
|
Right of use asset, net
|
(2,477)
|
Trade and other Payables
|
15,078
|
Deferred revenue
|
1,902
|
Lease liabilities (including
current potion)
|
4,146
|
Long-term loan (including current
portion)
|
15,446
|
Subsidiary preferred shares and
warrants
|
24,568
|
Other assets and liabilities,
net
|
(323)
|
Non-controlling interest
|
9,085
|
|
55,115
|
Investment retained in
deconsolidated subsidiary
|
20,456
|
Gain on deconsolidation
|
(61,787)
|
Cash in deconsolidated subsidiary
|
13,784
|
The accompanying notes are an
integral part of these financial statements.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
(Amounts in thousands, except share and per share data, or
exercise price and conversion price)
1.
General information
Description of Business
PureTech Health plc (the "Parent")
is a public biotherapeutics company dedicated to changing the
treatment paradigm for devastating diseases. It is incorporated,
domiciled and registered in the United Kingdom ("UK"). The
registered number is 09582467 and the registered address is 13th
Floor, One Angel Court, London, EC2R 7HJ, United
Kingdom.
The Parent and its subsidiaries are
together referred to as the "Group". The interim consolidated
financial statements of the Group (the "Condensed Consolidated
Financial Statements" or the "Interim Financial Statements")
consolidate those of the Parent and its subsidiaries.
The accounting policies are
consistent with those of the previous financial year and
corresponding interim reporting period, except for the adoption of
new and amended IFRS Accounting Standards as set out below in Note
2. New Standards and Interpretations.
Basis of accounting
These Interim Financial Statements
have been prepared in accordance with International Accounting
Standards (IAS) 34 Interim Financial Reporting as adopted for use
in the UK and also comply fully with IAS 34 as issued by the
International Accounting Standards Board ("IASB"). The Interim
Financial Statements should be read in conjunction with the Group's
Consolidated Financial Statements as of and for the year ended
December 31, 2023. The Interim Financial Statements do not include
all the information required for a complete set of financial
statements in accordance with International Financial Reporting
Standards ("IFRS"). However, selected explanatory notes are
included to explain events and transactions that are significant to
an understanding of the changes in the Group's financial position
and performance since the last annual consolidated financial
information included in the Annual Report and Accounts for the year
ended December 31, 2023, which was prepared in accordance with
UK-adopted International Financial Reporting Standards and also
complied fully with International Financial Reporting Standards as
issued by the IASB. Certain amounts in the Condensed Consolidated
Financial Statements and accompanying notes may not add due to
rounding. All percentages have been calculated using unrounded
amounts.
These Condensed Consolidated
Financial Statements do not comprise statutory accounts within the
meaning of Section 435 of the Companies Act 2006. The comparative
figures for the six months ended June 30, 2023 are not the Group's
statutory accounts for that financial year. Those accounts were
reported upon by the Group's auditors and delivered to the
registrar of companies. The report of the auditors was unqualified,
did not include a reference to any matters to which the auditors
drew attention by way of emphasis without qualifying their report
and did not contain statements under Section 498 (2) or (3) of the
Companies Act 2006.
The unaudited Condensed
Consolidated Financial Statements reflect all adjustments of a
normal recurring nature that are necessary for a fair statement of
the results for the interim periods presented. Interim results are
not necessarily indicative of results for a full year.
As of June 30, 2024 the Group had
cash and cash equivalents of $308,478 and short term investments of
$191,938. Considering the Group's financial position as of June 30,
2024 and its principal risks and opportunities, a going concern
analysis has been prepared for at least the twelve-month period
from the date of signing the Condensed Consolidated Financial
Statements ("the going concern period") utilizing realistic
scenarios and applying a severe but plausible downside scenario.
Even under the downside scenario, the analysis demonstrates the
Group continues to maintain sufficient liquidity headroom and
continues to comply with all financial obligations. Therefore, the
Board of Directors ("Directors") believes the Group is adequately
resourced to continue in operational existence for at least the
twelve-month period from the date of signing the Condensed
Consolidated Financial Statements. Accordingly, the Directors
considered it appropriate to adopt the going concern basis of
accounting in preparing the Condensed Consolidated Financial
Statements.
These Condensed Consolidated
Financial Statements were authorized for issue by the Company's
Board of Directors on August 28, 2024.
Material Accounting
policies
There have been no significant
changes in the Group's accounting policies from those disclosed in
our Consolidated Financial Statements as of and for the year ended
December 31, 2023. The significant accounting policies used for
half-year financial reporting are disclosed in Note 1, Material
Accounting policies of the accompanying notes to the Consolidated
Financial Statements included in our 2023 Annual Report and
Accounts.
2.New Standards and Interpretations
The Group has applied Amendments to
IAS 1 Presentation of Financial
Statements: Classification of Liabilities as Current or
Non-Current for the first time for its interim reporting
period ended June 30, 2024. This amendment did not have any impact
on the amounts recognized in prior and current periods.
In April 2024, IFRS 18,
Presentation and Disclosure in
Financial Statements was issued to achieve comparability of
the financial performance of similar entities. The standard, which
replaces IAS 1 Presentation of
Financial Statements, impacts the presentation of primary
financial statements and notes, including the statement of earnings
where companies will be required to present separate categories of
income and expense for operating, investing, and financing
activities with prescribed subtotals for each new category. The
standard will also require management-defined performance measures
to be explained and included in a separate note within the
consolidated financial statements. The standard is effective for
annual reporting periods beginning on or after January 1, 2027,
including interim financial statements, and requires retrospective
application. The Group is currently assessing the impact of the new
standard.
Certain other new accounting
standards, interpretations, and amendments to existing standards
have been published that are effective for annual periods
commencing on or after January 1, 2025 and have not been early
adopted by the Group in preparing the Condensed Consolidated
Financial Statements. These standards, amendments or
interpretations are not expected to have a material impact on the
Group in the prior and current periods.
3.Segment Information
Basis for Segmentation
The Directors are the Group's chief
operating decision-makers. The Group's operating segments are
determined based on the financial information provided to the Board
of Directors periodically for the purposes of allocating resources
and assessing performance. The Group has determined each of its
Wholly-Owned Programs represents an operating segment and the Group
has aggregated each of these operating segments into one reportable
segment, the Wholly-Owned Programs segment. Each of the Group's
Controlled Founded Entities represents an operating segment. The
Group aggregates each Controlled Founded Entity operating segment
into one reportable segment, the Controlled Founded Entities
segment. The aggregation is based on the high level of operational
and financial similarities of the operating segments. For the
Group's entities that do not meet the definition of an operating
segment, the Group presents this information in the Parent Company
and Other column in its segment footnote to reconcile the
information in this footnote to the Condensed Consolidated
Financial Statements. Substantially all of the Group's revenue and
profit generating activities are generated within the United States
and, accordingly, no geographical disclosures are
provided.
Following is the description of the
Group's reportable segments:
Wholly-Owned Programs
The Wholly-Owned Programs segment
is advancing Wholly-Owned Programs which are focused on treatments
for patients with devastating diseases. The Wholly-Owned Programs
segment is comprised of the technologies that are wholly-owned and
will be advanced through with either the Group's funding or
non-dilutive sources of financing. The operational management of
the Wholly-Owned Programs segment is conducted by the PureTech
Health team, which is responsible for the strategy, business
development, and research and development.
Controlled Founded
Entities
The Controlled Founded Entities
segment is comprised of the Group's consolidated operational
subsidiaries as of June 30, 2024 that either have, or have plans to
hire, independent management teams and currently have already
raised third-party dilutive capital. These subsidiaries have active
research and development programs and have entered into an equity
or debt investment partner, who will provide additional industry
knowledge and access to networks, as well as additional funding to
continue the pursued growth of the entity.
The Group's entities that were
determined not to meet the definition of an operating segment are
included in the Parent Company and Other column to reconcile the
information in this footnote to the Condensed Consolidated
Financial Statements. This column captures activities not directly
attributable to the Group's operating segments and includes the
activities of the Parent, corporate support functions and certain
research and development support functions that are not directly
attributable to a strategic business segment as well as the
elimination of intercompany transactions. This column also captures
the operating results for the deconsolidated entities through the
date of deconsolidation (e.g. Vedanta in 2023) and accounting for
the Group's holdings in Founded Entities for which control has been
lost, which primarily represents: the activity associated with
deconsolidating an entity when the Group no longer controls the
entity (e.g. Vedanta in 2023), the gain or loss on the Group's
investments accounted for at fair value (e.g. the Group's ownership
stakes in Karuna, Vor and Akili) and the Group's net income or loss
of associates accounted for using the equity method.
(The term "Founded Entities" refers
to entities which the Company incorporated and announced the
incorporation as a Founded Entity externally. It includes certain
of the Company's wholly-owned subsidiaries which have been
announced by the Company as Founded Entities, Controlled Founded
Entities and deconsolidated Founded Entities.)
In January 2024, the Group launched
two new Founded Entities (Seaport Therapeutics "Seaport" and Gallop
Oncology "Gallop") to advance certain programs from the
Wholly-Owned Programs segment. The financial results of these
programs were included in the Wholly-Owned Programs segment as of
and for the year ended December 31, 2023. Upon raising dilutive
third-party financing in April 2024, the financial results of
Seaport are included within the Controlled Founded Entities Segment
as the Group still maintains control over this entity.
As of June 30, 2024, Alivio became
dormant and did not meet the definition of operating segment. The
financial results of this entity were removed from the Wholly-Owned
Programs segment and are included in the Parent Company and Other
column. The corresponding information for 2023 has been restated to
include Alivio in the Parent Company and Other column so that the
segment disclosures are presented on a comparable basis.
The Group's Board of Directors
reviews segment performance and allocates resources based upon
revenue, operating loss as well as the funds available for each
segment. The Board of Directors does not review any other
information for purposes of assessing segment performance or
allocating resources.
|
For the six months
ended June 30, 2024
|
|
Wholly-Owned
Programs
$
|
Controlled Founded
Entities
$
|
Parent Company
and
Other
$
|
Consolidated
$
|
Contract revenue
|
-
|
-
|
-
|
-
|
Grant revenue
|
288
|
-
|
-
|
288
|
Total revenue
|
288
|
-
|
-
|
288
|
General and administrative
expenses
|
(4,450)
|
(6,548)
|
(16,759)
|
(27,758)
|
Research and development
expenses
|
(32,981)
|
(5,710)
|
(237)
|
(38,928)
|
Total operating expense
|
(37,431)
|
(12,258)
|
(16,997)
|
(66,686)
|
Operating income/(loss)
|
(37,143)
|
(12,258)
|
(16,997)
|
(66,398)
|
Income/expenses not allocated to
segments
|
|
|
|
|
Other income/(expense):
|
|
|
|
|
Gain/(loss) on investment held at
fair value
|
|
|
|
3,882
|
Realized loss on sale of
investments
|
|
|
|
151
|
Gain/(loss) on investment in notes
from associates
|
|
|
|
11,612
|
Other income/(expense)
|
|
|
|
548
|
Total other
income/(expense)
|
|
|
|
16,193
|
Net finance
income/(costs)
|
|
|
|
(1,468)
|
Share of net income/(loss) of
associates accounted for using the equity method
|
|
|
|
(3,357)
|
Income/(loss) before taxes
|
|
|
|
(55,030)
|
|
As of June 30,
2024
|
Available Funds
|
|
|
|
|
Cash and cash
equivalents
|
24,781
|
99,359
|
184,338
|
308,478
|
Short-term Investments
|
-
|
-
|
191,938
|
191,938
|
Consolidated cash, cash equivalents
and short-term investments
|
24,781
|
99,359
|
376,276
|
500,416
|
|
For the six months ended June 30, 2023
|
|
Wholly-Owned Programs
$
|
Controlled Founded Entities
$
|
Parent
Company
and
Other
$
|
Consolidated
$
|
Contract revenue
|
-
|
750
|
-
|
750
|
Grant revenue
|
135
|
-
|
2,265
|
2,400
|
Total revenue
|
135
|
750
|
2,265
|
3,150
|
General and administrative
expenses
|
(6,981)
|
(237)
|
(18,947)
|
(26,166)
|
Research and development
expenses
|
(45,139)
|
(368)
|
(7,640)
|
(53,146)
|
Total Operating expenses
|
(52,120)
|
(605)
|
(26,588)
|
(79,312)
|
Operating income/(loss)
|
(51,985)
|
145
|
(24,323)
|
(76,163)
|
Income/expenses not allocated to
segments
|
|
|
|
|
Other income/(expense):
|
|
|
|
|
Gain on deconsolidation
|
|
|
|
61,787
|
Gain/(loss) on investment held at
fair value
|
|
|
|
7,818
|
Gain/(loss) on investment in notes
from associates
|
|
|
|
(6,045)
|
Other income/(expense)
|
|
|
|
(1,134)
|
Total other
income/(expense)
|
|
|
|
62,426
|
Net finance
income/(costs)
|
|
|
|
5,316
|
Share of net income/(loss) of
associate accounted for using the equity method
|
|
|
|
(5,324)
|
Income/(loss) before
taxes
|
|
|
|
(13,744)
|
|
As of
December 31, 2023
|
Available Funds
|
|
|
|
|
Cash and cash
equivalents
|
1,895
|
675
|
188,511
|
191,081
|
Short-term Investments
|
-
|
-
|
136,062
|
136,062
|
Consolidated cash, cash equivalents
and short-term investments
|
1,895
|
675
|
324,573
|
327,143
|
4.
Investments Held at Fair Value
Investments held at fair value
include both unlisted and listed securities held by the Group.
These investments, which include interests in Akili, Vor, Sonde,
Vedanta and other insignificant investments, are initially measured
at fair value and are subsequently re-measured at fair value at
each reporting date with changes in the fair value recorded through
profit and loss. See Note 13. Financial Instruments for information
regarding the valuation of these instruments. Activities related to
such investments during the periods are shown below:
Investments held at fair
value
|
$
|
Balance as of December 31, 2023 and
January 1, 2024
|
317,841
|
Sale of Karuna shares
|
(292,672)
|
Gain realised on sale of
investments
|
151
|
Gain - change in fair value through
profit and loss
|
3,882
|
Balance as of June 30, 2024 before allocation of equity method
loss to long-term interest ("LTI")
|
29,202
|
Equity method loss recorded against
LTI
|
(172)
|
Balance as of June 30, 2024 after allocation of equity method
loss to LTI
|
29,030
|
Vedanta
On March 1, 2023 Vedanta issued
convertible debt to a syndicate of investors. The Group did not
participate in this round of financing. As part of the issuance of
the debt, the convertible debt holders were granted representation
on Vedanta's Board of Directors and the Group lost control over the
Vedanta's Board of Directors and the power to direct the relevant
Vedanta activities. Consequently, Vedanta was deconsolidated on
March 1, 2023 and its results of operations were included in the
Condensed Consolidated Financial Statements through the date of
deconsolidation.
Following deconsolidation, the
Group still has significant influence over Vedanta through its
voting interest in Vedanta and its remaining representation on
Vedanta's Board of Directors. However, the Group only holds
convertible preferred shares in Vedanta that do not provide their
holders with access to returns associated with a residual equity
interest, and as such, are accounted for under IFRS 9, as
investments held at fair value with changes in fair value recorded
in profit and loss. Under IFRS 9, the preferred share investments
are categorized as debt instruments that are presented at fair
value through profit and loss because the amounts receivable do not
represent solely payments of principal and interest.
Upon deconsolidation, the Group
derecognized its assets, liabilities and non-controlling interest
in respect of Vedanta and recorded its aforementioned investment in
Vedanta at fair value. The deconsolidation resulted in a gain of
$61,787.
During the six months ended June
30, 2024 and June 30, 2023, the Group recognized a loss of $3,648
and $2,171, respectively for the changes in the fair value of the
investment in Vedanta that was included in gain/(loss) on
investments held at fair value within the Condensed Consolidated
Statement of Comprehensive Income/(Loss). The fair value of the
Group's investment in Vedanta was $10,505 and $14,153 as of June
30, 2024 and December 31, 2023, respectively.
Karuna
As of December 31, 2023, the Group
held 886,885 shares or 2.3 percent of total outstanding Karuna
common stock with fair value of $280,708. In March 2024, Karuna
common shares were acquired by Bristol Myers Squibb ("BMS") for
$330 per share in accordance with the terms of a definitive merger
agreement signed in December 2023. As a result of this transaction,
the Group received total proceeds of $292,672 before income tax in
exchange for its holding of 886,885 shares of Karuna common
stock.
During the six months ended June
30, 2024 and 2023, the Group recognized a gain of $11,813 and
$21,458, respectively, for the changes in the fair value of its
investment in Karuna that was included in gain/(loss) on
investments held at fair value within the Condensed Consolidated
Statement of Comprehensive Income/(Loss).
Sonde
On May 25, 2022, Sonde completed a
Series B preferred share financing, which resulted in the Group
losing control over Sonde and the deconsolidation of
Sonde.
Following deconsolidation, the
Group still had significant influence in Sonde through its voting
interest in Sonde and its remaining representation on Sonde's Board
of Directors. The Group holds Preferred A-1, A-2 and B shares. The
Preferred A-1 shares have the same terms as common stock, and
provide their shareholders with access to returns associated with a
residual equity ownership in Sonde. Consequently, the investment in
Preferred A-1 shares is accounted for under the equity method. See
Note 5. Investments in Associates. The convertible Preferred A-2
and B shares, however, do not provide their shareholders with
access to returns associated with a residual equity interest, and
as such, are accounted for under IFRS 9, as investments held at
fair value with changes in fair value recorded in profit and loss.
Under IFRS 9, the A-2 and B preferred share investments are
categorized as debt instruments that are presented at fair value
through profit and loss because the amounts receivable do not
represent solely payments of principal and interest.
During the six months ended June
30, 2024 and 2023, the Group recognized a gain of $163, and a loss
of $167, respectively, for the change in the fair value of its
investment in Sonde that were included in gain/(loss) on
investments held at fair value within the Condensed Consolidated
Statement of Comprehensive Income/(Loss). The fair value of the
Group's investment in Sonde was $10,571 and $10,408 as of June 30,
2024 and December 31, 2023, respectively. As the Group's investment
in
Sonde is considered to be a long
term interest, a loss of $172 from Sonde's equity method of
accounting was applied to the investment balance, reducing the
balance to $10,399.
Vor
During the six months ended June
30, 2024 and 2023, the Group recognized a loss of $3,340 and
$9,512, respectively, for the change in the fair value of its
investment in Vor that was included in gain/(loss) on investments
held at fair value within the Condensed Consolidated Statement of
Comprehensive Income/(Loss). The fair value of the Group's
investment in Vor was $2,672 and $6,012 as of June 30, 2024 and
December 31, 2023, respectively.
Akili
During the six months ended June
30, 2024 and 2023, the Group recognized a loss of $985 and $354,
respectively, for the changes in the fair value of its investment
in Akili that were included in gain/(loss) on investments held at
fair value within the Condensed Consolidated Statement of
Comprehensive Income/(Loss). The fair value of the Group's
investment in Akilli was $5,437 and $6,422 as of June 30, 2024 and
December 31, 2023, respectively.
On July 2, 2024, Akili was acquired
by Virtual Therapeutics. As a result of this transaction, the Group
received total proceeds of $5,437 before income taxes in exchange
for its holding of 12,527,476 shares of Akili common
stock.
5.
Investments in Associates
Gelesis
Gelesis was founded by the Group
and raised funding through preferred shares financings as well as
issuances of warrants and loans. As of July 1, 2019, Gelesis was
deconsolidated from the Group's financial statements. Upon
deconsolidation, the preferred shares and warrants held by the
Group fell under the guidance of IFRS 9 Financial Instruments and were treated
as financial assets held at fair value and the investment in common
shares of Gelesis was subject to IAS 28 Investment in Associates as the Group
had significant influence over Gelesis.
During the year ended December 31,
2023, the Group entered into agreements with Gelesis to purchase
senior secured convertible promissory notes and warrants for shares
of Gelesis common stock (see Note 6. Investment in Notes from
Associates). The warrants to purchase shares of Gelesis common
stock represented potential voting rights to the Group and it is
therefore necessary to consider whether they were substantive. If
these potential voting rights were substantive and the Group had
the practical ability to exercise the rights and take control of
greater than 50% of Gelesis common stock, the Group would be
required to consolidate Gelesis under the accounting
standards.
In February 2023, the Group
obtained warrants to purchase 23,688,047 shares of Gelesis common
stock (the "February Warrants") at an exercise price of $0.2744 per
share. The exercise of the February Warrants was subject to the
approval of the Gelesis stockholders until May 1, 2023. On May 1,
2023, stockholder approval was no longer required for the Group to
exercise the February Warrants. The potential voting rights
associated with the February Warrants were not substantive as the
exercise price of the February Warrants was at a significant
premium to the fair value of the Gelesis common stock.
In May 2023, the Group obtained
warrants to purchase 235,441,495 shares of Gelesis common stock
(the "May Warrants"). The May Warrants were exercisable at the
option of the Group and had an exercise price of either $0.0182 or
$0.0142. The May Warrants were substantive as the Group would have
benefited from exercising such warrants since their exercise price
was at the money or at an insignificant premium over the fair value
of the Gelesis common stock. However, that benefit from exercising
the May Warrants only existed for a short period of time because in
June 2023, the potential voting rights associated with the May
Warrants were impacted by the terms and conditions of a merger
agreement that the Group signed with Gelesis on June 12, 2023 (the
"Merger Agreement") and were no longer substantive.
On October 12, 2023, the Group
terminated the Merger Agreement with Gelesis as certain closing
conditions were not satisfied. In October 2023, Gelesis ceased
operations and filed a voluntary petition for relief under the
provisions of Chapter 7 of Title 11 of the United States Bankruptcy
Code. A Chapter 7 trustee has been appointed by the Bankruptcy
Court who has control over the assets and liabilities of Gelesis,
effectively eliminating the authority and powers of the Board of
Directors of Gelesis and its executive officers to act on behalf of
Gelesis. The assets of Gelesis are in liquidation and Gelesis no
longer has any officers or employees. The Group ceased accounting
for Gelesis as an equity method investment as it no longer has
significant influence in Gelesis.
During the year ended December 31,
2023, the Group recorded $4,910 as its share in the losses of
Gelesis with $3,787 recorded in the first six months. The Group's
balance in this equity method investment was $- as of June 30, 2024
and December 31, 2023.
Sonde
Following deconsolidation of Sonde
on May 25 2022, the Group has significant influence in Sonde
through its voting interest in Sonde and its remaining
representation on Sonde's Board of Directors. The Group holds
Preferred A-1, A-2 and B shares. The Preferred A-1 shares, in
substance, have the same terms as common stock and as such, provide
their shareholders with access to returns associated with a
residual equity ownership in Sonde. Consequently, the investment in
Preferred A-1 shares is accounted for under the equity method of
accounting. The Preferred A-2 and B shares, however, do not provide
their shareholders with access to returns associated with a
residual equity interest, and as such, are accounted for under IFRS
9, as investments held at fair value.
During the six months ended June
30, 2024 and 2023, the Group recorded a loss of $3,357 and $1,537,
respectively, related to Sonde's equity method of accounting.
As of December 31, 2023, the Sonde equity method investment had a
balance of $3,185. The Group's share of Sonde's loss in the six
months ended June 30, 2024 has reduced the Group's investment in
this associate to $0. The excess loss of $172 was applied against
the fair value of Sonde Preferred A-2 and B shares, which are
considered to be long term interests.
6.
Investment in Notes from Associates
Gelesis
On July 27, 2022, the Group, as a
lender, entered into an unsecured promissory note (the "Junior
Note") with Gelesis, as a borrower, in the amount of $15,000. The
Junior Note bears an annual interest rate of 15% per annum. The
maturity date of the Junior Note is the earlier of December 31,
2023 or five business days following the consummation of a
qualified financing by Gelesis. Based on the terms of the Junior
Note, due to the option to convert to a variable amount of shares
at the time of default, the Junior Note is required to be measured
at fair value with changes in fair value recorded through profit
and loss.
During the year ended December 31,
2023, the Group entered into multiple agreements with Gelesis to
purchase senior secured convertible promissory notes (the "Senior
Notes") and warrants for share of Gelesis common stock for a total
consideration of $11,850. The Senior Notes are secured by a
first-priority lien on substantially all assets of Gelesis and the
guarantors (other than the equity interests in, and assets held by
Gelesis s.r.l., a subsidiary of Gelesis, and certain other
exceptions). The initial fair value of the Senior Notes was
determined to be $10,729 while $1,121 was determined to be the
initial fair value of the warrants. The Senior Notes represent debt
instruments that are presented at fair value through profit and
loss as the amounts receivable do not solely represent payments of
principal and interest as the Senior Notes are convertible into
Gelesis common stock.
In October 2023, Gelesis ceased
operations and filed a voluntary petition for relief under the
provisions of Chapter 7 of Title 11 of the United States Bankruptcy
Code. Therefore, the Group determined that the fair value of the
Junior Note and the Senior Notes with the warrants was $0 as of
December 31, 2023. For the six months ended June 30, 2023 and year
ended December 31, 2023, the Group recorded a loss of $5,945 and
$27,230, respectively, for the changes in the fair value of these
instruments which were included in gain/(loss) on investments in
notes from associates in the Condensed Consolidated Statement of
Comprehensive Income/(Loss).
In June 2024, the Bankruptcy Court
approved an executed agreement for a third party to acquire the
remaining net assets of Gelesis for $15,000. As the only senior
secured creditor, the Group is expected to receive a majority of
the proceeds from this sale after deduction of Bankruptcy Court
related legal and administrative costs. As of June 30, 2024, these
notes were determined to have a fair value of $11,312. The Group
recorded a gain of $11,312 for the changes in the fair value of
these notes which were included in gain/(loss) on investments in
notes from associates in the Condensed Consolidated Statement of
Comprehensive Income/(Loss).
Vedanta
On April 24, 2023, Vedanta closed
the second tranche of its convertible debt for additional proceeds
of $18,000, of which $5,000 were invested by the Group. The
convertible debt carries an interest rate of 9 percent per annum.
The debt has various conversion triggers and the conversion price
is established at the lower of 80% of the equity price of the last
financing round, or a certain pre-money valuation cap established
in the agreement. If the convertible debt is not earlier converted
or repaid, the entire outstanding amount of the convertible debt
shall be due and payable upon the earliest to occur of (a) the
later of (x) November 1, 2025 and (y) the date which is sixty (60)
days after all amounts owed under, or in connection with, the loan
Vedanta received from a certain investor have been paid in full, or
(b) the consummation of a Deemed Liquidation Event (as defined in
Vedanta's Amended and Restated Certificate of
Incorporation).
Due to the terms of the convertible
debt, the investment in such convertible debt is measured at fair
value with changes in the fair value recorded through profit and
loss. During the six months ended June 30, 2024 and June 30, 2023,
the Group recorded a gain of $300 and a loss of $100, respectively,
for the changes in the fair value of the Vedanta convertible debt,
which were included in gain/(loss) on investments in notes from
associates in the Condensed Consolidated Statement of Comprehensive
Income/(Loss).
Following is the activity in
respect of investments in notes from associates during the
period. The fair
value of the $16,212 notes from associates as of June 30, 2024 is
determined using unobservable Level 3 inputs. See Note 13.
Financial Instruments for additional information.
Investment in notes from
associates
|
$
|
Balance as of December 31, 2023 and
January 1, 2024
|
4,600
|
Changes in the fair value of the
notes
|
11,612
|
Balance as of June 30, 2024
|
16,212
|
7.Share-based Payments
Share-based payments includes stock
options and restricted stock units ("RSUs"). Expense for stock
options and time-based RSUs is recognized based on the grant date
fair value of these awards. Performance-based RSUs to executives
are treated as liability awards and the related expense is
recognized based on reporting date fair value up until settlement
date.
Share-based Payment
Expense
The Group's share-based payment
expense for the six months ended June 30, 2024 and 2023 was $4,648
and $1,256, respectively. The following table provides the
classification of the Group's consolidated share-based payment
expense as reflected in the Condensed Consolidated Statement of
Comprehensive Income/(Loss):
Six months ended June
30,
|
2024
$
|
2023
$
|
General and
administrative
|
4,471
|
1,121
|
Research and development
|
176
|
135
|
Total
|
4,648
|
1,256
|
The Performance Share
Plan
In June 2015, the Group adopted the
Performance Stock Plan (the "2015 PSP"). Under the 2015 PSP and
subsequent amendments, awards of ordinary shares may be made to the
Directors, senior managers and employees, and other individuals
providing services to the Group up to a maximum authorized amount
of 10.0 percent of the total ordinary shares
outstanding.
In June 2023 the Group adopted a
new Performance Stock Plan (the "2023 PSP") that has the same terms
as the 2015 PSP but instituted for all new awards a limit of 10.0
percent of the total ordinary shares outstanding over a five-year
period.
The awards granted under these
plans have various vesting terms over a period of service between
one and four years, provided the recipient remains continuously
engaged as a service provider. The options awards expire 10 years
from the grant date.
The share-based awards granted
under these plans are generally equity-settled (see cash
settlements below). As of June 30, 2024, the Group had issued
31,654,895 units of share-based awards under these
plans.
RSUs
During the six months ended June
30, 2024 and 2023, the Group granted the following RSUs to certain
non-executive Directors, executives and employees:
Six months ended June
30,
|
2024
|
2023
|
Time based RSUs
|
3,933,606
|
102,732
|
Performance based RSUs
|
1,822,151
|
3,576,937
|
Total RSUs
|
5,755,757
|
3,679,669
|
Each RSU entitles the holder to one
ordinary share on vesting and the RSU awards are generally based on
a vesting schedule over a one to three-year requisite service
period in which the Group recognizes compensation expense for the
RSUs. Following vesting, each recipient will be required to make a
payment of one pence per ordinary share on settlement of the
RSUs.
Time-based RSUs are equity-settled.
The grant date fair value on such RSUs is recognized over the
vesting term.
Performance-based RSUs are granted
to executives. Vesting of such RSUs is subject to the satisfaction
of both performance and market conditions. The performance
condition is based on the achievement of the Group's strategic
targets. The market conditions are based on the achievement of the
absolute total shareholder return ("TSR"), TSR as compared to the
FTSE 250 Index, and TSR as compared to the MSCI Europe Health Care
Index. The RSU award performance criteria have changed over time as
the criteria are continually evaluated by the Group's Remuneration
Committee.
The Group recognizes the estimated
fair value of performance-based awards with non-market conditions
as share-based compensation expense over the performance period
based upon its determination whether it is probable that the
performance targets will be achieved. The Group assesses the
probability of achieving the performance targets at each reporting
period. Cumulative adjustments, if any, are recorded to reflect
subsequent changes in the estimated outcome of performance-related
conditions.
The fair value of the
performance-based awards with market conditions is based on the
Monte Carlo simulation analysis utilizing a Geometric Brownian
Motion process with 100,000 simulations to value those shares. The
model considers share price volatility, risk-free rate and other
covariance of comparable public companies and other market data to
predict distribution of relative share performance.
The RSUs to executives are treated
as liability awards as the Group has a historical practice of
settling these awards in cash, and as such, adjusted to fair value
at every reporting date until settlement with changes in fair value
recorded in earnings as stock based compensation
expense.
In May 2024, the Group settled
237,420 vested RSUs through issuance of shares to a terminated
employee. As such, the liability at the date of settlement was
settled for $646 in shares.
In March 2024, the Group settled
518,721 vested RSUs through issuance of shares after paying the
employees' withholding taxes in cash. As such, the liability at the
date of settlement was settled for $655 in cash and $655 in
shares.
In February and May 2023, the Group
settled 276,425 vested RSUs through issuance of shares, after
paying the employees' withholding taxes in cash. As such, the
liability at dates of settlement was settled for $298 in cash and
$424 in shares.
The Group recorded $973 expense and
$235 income for the six months ended June 30, 2024 and 2023,
respectively, in respect of all restricted stock
units, of which $609 expense and $485 income, respectively, was in
respect of liability settled share-based awards.
As of June 30, 2024, the carrying
amount of the RSU liability awards was $3,435 with $1,886 current
and $1,550 non current. As of December 31, 2023, the carrying
amount of the RSU liability awards was $4,782 with $1,281 current
and $3,501 non current, out of which $1,281 related to awards that
met all their performance and market conditions and were settled in
March and May of 2024 as discussed above.
Stock Options
During the six months ended June
30, 2024 and 2023, the Group granted 2,548,375 and 569,125 stock
option awards, respectively.
Stock options are treated as
equity-settled awards. The fair value of the stock options awarded
by the Group was estimated at the grant date using the
Black-Scholes option valuation model, considering the terms and
conditions upon which options were granted, with the following
weighted- average assumptions:
For the six months ended June
30,
|
2024
|
2023
|
Expected volatility
|
44.79%
|
43.45%
|
Expected terms (in
years)
|
6.16
|
6.16
|
Risk-free interest rate
|
4.32%
|
3.66%
|
Expected dividend yield
|
-
|
-
|
Exercise price (GBP)
|
1.88
|
2.29
|
Underlying stock price
(GBP)
|
1.88
|
2.29
|
These assumptions resulted in an
estimated weighted-average grant-date fair value per share of stock
options granted during the six months ended June 30, 2024, and 2023
of $1.19, and $1.38, respectively.
As of June 30, 2024, 9,191,140
incentive options are exercisable with a weighted-average exercise
price of £2.20. Exercise prices ranged from £0.01 to
£3.60.
The Group incurred share-based
payment expense for the stock options of $390 and $1,215 for the
six months ended June 30, 2024 and 2023, respectively.
Subsidiary Plans
The subsidiaries incurred $3,285
and $277 in share-based payment expense in
respect of their share-based award plans for the six months ended
June 30, 2024 and 2023, respectively.
The share-based payment expense for
the six months ended June 30, 2024 is primarily related to the
Seaport Plan discussed below.
In 2024, the Board of Directors of
Seaport approved the 2024 Equity Incentive Plan (the "Seaport
Plan"). The options granted under the Seaport Plan are equity
settled and expire 10 years from the grant date. Typically, the
awards vest in four years but vesting conditions can vary based on
the discretion of Seaport's Board of Directors.
The estimated grant date fair value
of the equity awards is recognized as an expense over the awards'
vesting periods.
In the six months ended June 30,
2024, Seaport granted 3,450,000 shares of restricted stock to
certain officers and directors, of which 1,227,778 shares are fully
vested as of June 30, 2024. Seaport also granted 14,859,335 stock
options awards to its non-executive Directors, executives and
employees. The fair value of the restricted stock is estimated at
the date of grant using the market backsolve and two-scenario
option pricing model. See Note 13. Financial Instruments. The fair
value of the stock option grants was estimated at the date of grant
using the Black-Scholes option pricing model with the following
weighted-average assumptions:
For the six months ended June
30,
|
2024
|
Expected volatility
|
80.00%
|
Expected terms (in
years)
|
5.75
|
Risk-free interest rate
|
4.34%
|
Expected dividend yield
|
-
|
Exercise price
|
$0.97
|
Underlying stock price
|
$0.97
|
These assumptions resulted in an
estimated weighted-average grant-date fair value of $0.68 per share
for stock options granted during the six months ended June 30,
2024.
8.Finance Income/(Costs), net
The following table shows the
breakdown of finance income and costs:
|
2024
$
|
2023
$
|
For the six months ended June
30,
|
Finance income
|
|
|
Interest income from financial
assets
|
11,732
|
7,731
|
Total finance income
|
11,732
|
7,731
|
Finance costs
|
|
|
Contractual interest expense on
notes payable
|
(328)
|
(82)
|
Interest expense on other
borrowings
|
-
|
(363)
|
Interest expense on lease
liability
|
(675)
|
(817)
|
Gain/(loss) on foreign currency
exchange
|
(33)
|
(76)
|
Total finance cost - contractual
|
(1,036)
|
(1,338)
|
Gain/(loss) from change in fair
value of warrant liability
|
-
|
33
|
Gain/(loss) from change in fair
value of preferred shares
|
(1,613)
|
2,617
|
Total finance income/(costs) - fair value
accounting
|
(1,613)
|
2,650
|
Total finance costs - non cash interest expense related to
sale of future royalties
|
(10,551)
|
(3,726)
|
Finance income/(costs), net
|
(1,468)
|
5,316
|
9.Earnings/(Loss) per Share
Basic earnings/(loss) per share is
computed by dividing the Group's income or loss for the period
attributable to ordinary shareholders by the weighted average
number of ordinary shares outstanding, net of treasury
shares.
Dilutive earnings/loss per share is
computed by dividing the Group's income or loss for the period
attributable to ordinary shareholders by the weighted average
number of ordinary shares outstanding, net of treasury shares, plus
the weighted average number of ordinary shares that would be issued
at conversion of all the dilutive potential securities into
ordinary shares. Dilutive effects arise from equity-settled shares
from the Group's share-based plans.
During the six months ended June
30, 2024 and 2023, the Group incurred a net loss, and therefore,
all outstanding potential securities were considered anti-dilutive.
The amount of potential securities that were excluded from the
diluted calculation amounted to 1,637,694 and 1,878,514 shares for
the six months ended June 30, 2024 and 2023,
respectively.
The following table sets forth the
computation of basic and diluted earnings/(loss) per share for the
periods presented:
ForForfor For the six
months ended June 30,
|
2024
|
|
2023
|
Numerator:
|
|
|
|
Income/(loss) attributable to the
owners of the Group
|
($41,773)
|
|
($25,004)
|
Denominator:
|
|
|
|
Issued ordinary shares at January
1
|
271,853,731
|
|
278,566,306
|
Effect of shares issued &
treasury shares purchased and cancelled
|
(2,197,209)
|
|
(311,925)
|
Weighted average ordinary shares
for basic EPS
|
269,656,522
|
|
278,254,381
|
Effect of dilutive
securities
|
-
|
|
-
|
Weighted average ordinary shares
for diluted EPS
|
269,656,522
|
|
278,254,381
|
Basic earnings/(loss) per ordinary
share
|
($0.15)
|
|
($0.09)
|
Diluted earnings/(loss) per
ordinary share
|
($0.15)
|
|
($0.09)
|
10. Equity
On May 9, 2022, the Group announced
the commencement of a $50,000 share repurchase program (the
"Program") of its ordinary shares of one pence each. The Group
executed the Program in two equal tranches. It entered into an
irrevocable non-discretionary instruction with Jefferies
International Limited ("Jefferies") in relation to the purchase by
Jefferies of the ordinary shares for an aggregate consideration
(excluding expenses) of no greater than $25,000 for each tranche
and the simultaneous on-sale of such ordinary shares by Jefferies
to the Group, subject to certain volume and price restrictions. In
February 2024, the Group completed the Program and has repurchased
an aggregate of 20,182,863 ordinary shares under the Program. These
shares have been held as treasury shares and are being used to
settle the vesting of restricted stock units or exercise of stock
options.
In March 2024, the Group announced
a proposed capital return of $100,000 to its shareholders by way of
a tender offer (the "Tender Offer"). The proposed Tender Offer was
approved by shareholders at the Annual General Meeting of
Stockholders held on June 6, 2024, to acquire a maximum number of
33,500,000 ordinary shares (including ordinary shares represented
by American Depository Shares (''ADSs'')) for a fixed price of 250
pence per ordinary share (equivalent to £25.00 per ADS) for a
maximum aggregate amount of $100,000 excluding expenses.
The Tender Offer was completed on
June 24, 2024. The Group repurchased 31,540,670 ordinary shares
under the Tender Offer. Following such repurchase, the Group
cancelled these shares repurchased. As a result of the
cancellation, the nominal value of $600 related to the cancelled
shares was reduced from share capital and transferred to a capital
redemption reserve, increasing the capital redemption reserve
balance to $600 as of June 30, 2024 which was included in other
reserve in the Condensed Consolidated Statement of Changes in
Equity.
As of December 31, 2023, the Group
had 271,853,731 common shares outstanding, including 289,468,159
issued shares net of 17,614,428 shares repurchased and held by the
Group in Treasury. As of June 30, 2024, the Group had 239,421,312
common shares outstanding, including 257,927,489 issued shares
after deducting 31,540,670 cancelled ordinary shares repurchased
through the Tender Offer, net of 18,506,177 shares repurchased and
held by the Group in Treasury.
11. Subsidiary Preferred Shares
In April 2024, Seaport closed a
Series A-2 preferred share financing with aggregate proceeds of
$100,100 of which $68,100 was from outside investors and $32,000
was from the Group. As of June 30, 2024, the Group held equity
ownership in Seaport of 57.7 percent on a diluted basis.
Preferred shares issued by
subsidiaries often contain redemption and conversion features that
are assessed under IFRS 9 in conjunction with the host preferred
share instrument. This balance represents subsidiary preferred
shares issued to third parties.
The subsidiary preferred shares are
redeemable upon the occurrence of a contingent event, other than
full liquidation of the subsidiaries, that is not considered to be
within the control of the subsidiaries. Therefore, these subsidiary
preferred shares are classified as liabilities. These liabilities
are measured at fair value through profit and loss. The preferred
shares are convertible into ordinary shares of the subsidiaries at
the option of the holders and are mandatorily convertible into
ordinary shares under certain circumstances. Under certain
scenarios, the number of ordinary shares receivable on conversion
will change and therefore, the number of shares that will be issued
is not fixed. As such, the conversion feature is considered to be
an embedded derivative that normally would require bifurcation.
However, since the preferred share liabilities are measured at fair
value through profit and loss, as mentioned above, no bifurcation
is required.
The preferred shares are entitled
to vote with holders of common shares on an as converted
basis.
The fair value of all subsidiary
preferred shares as of June 30, 2024 and December 31, 2023, is as
follows:
|
2024
$
|
2023
$
|
As of June 30, 2024 and December
31, 2023
|
Entrega
|
169
|
169
|
Seaport
|
69,713
|
-
|
Total subsidiary preferred share balance
|
69,882
|
169
|
As is customary, in the event of
any voluntary or involuntary liquidation, dissolution or winding up
of a subsidiary, the holders of outstanding subsidiary preferred
shares shall be entitled to be paid out of the assets of the
subsidiary available for distribution to shareholders and before
any payment shall be made to holders of ordinary shares. A merger,
acquisition, sale of voting control or other transaction of a
subsidiary in which the shareholders of the subsidiary immediately
before the transaction do not own a majority of the
outstanding shares of the surviving company shall be deemed to be a
liquidation event. Additionally, a sale, lease, transfer or other
disposition of all or substantially all of the assets of the
subsidiary shall also be deemed a liquidation event.
As of June 30, 2024 and December
31, 2023, the minimum liquidation preference reflecting the amounts
that would be payable to the subsidiary preferred holders upon a
liquidation event of the subsidiaries, is as follows:
|
2024
$
|
2023
$
|
As of June 30, 2024 and December
31, 2023
|
Entrega
|
2,216
|
2,216
|
Follica
|
6,405
|
6,405
|
Seaport
|
68,100
|
-
|
Total minimum liquidation preference
|
76,721
|
8,621
|
For the six months ended June 30,
2024, the Group recognized the following changes in the value of
subsidiary preferred shares:
|
Subsidiary Preferred Shares
$
|
|
Balance as of December 31
2023
|
169
|
Issuance of new preferred
shares
|
68,100
|
Increase/(decrease) in value of
preferred shares measured at fair value*
|
1,613
|
Balance as of June 30
|
69,882
|
*The changes in fair value of
preferred shares are included in total finance income/(costs) -
fair value accounting in the Condensed Consolidated Statement of
Comprehensive Income/(Loss).
12. Sale of Future Royalties Liability
On March 4, 2011, the Group entered
into a license agreement with Karuna Therapeutics, Inc. ("Karuna")
according to which the Group granted Karuna an exclusive license to
research, develop and sell KarXT in exchange for a royalty on
annual net sales, development and regulatory milestones and a fixed
portion of sublicensing income, if any (hereinafter "License
Agreement").
On March 22, 2023, the Group signed
an agreement with Royalty Pharma (the "Royalty Purchase
Agreement"), according to which the Group sold Royalty Pharma a
partial right to receive royalty payments made by Karuna in respect
of net sales of KarXT, if and when received. According to the
Royalty Purchase Agreement, all royalties due to the Group under
the License Agreement will be paid to Royalty Pharma up until an
annual sales threshold of $60,000, while all royalties above such
annual threshold in a given year will be split 33% to Royalty
Pharma and 67% to the Group. Under the terms of the Royalty
Purchase Agreement, the Group received a non-refundable initial
payment of $100,000 at the execution of the Royalty Purchase
Agreement and is eligible to receive additional payments in the
aggregate of up to an additional $400,000 based on the achievement
of certain regulatory and commercial milestones.
The Group continues to hold the
rights under the License Agreement and has a contractual obligation
to deliver cash to Royalty Pharma for a portion of the royalties it
receives. Therefore, the Group will continue to account for any
royalties and regulatory milestones due to the Group under the
License Agreement as revenue and record the proceeds from the
Royalty Purchase Agreement as a financial liability on its
financial statements. In determining the appropriate accounting
treatment for the Royalty Purchase Agreement, management applied
significant judgement.
The acquisition of Karuna by
Bristol Myers Squibb (NYSE: BMY), which closed on March 18, 2024,
had no impact on the Group's rights or obligations under the
License Agreement or Royalty Purchase Agreement, each of which
remains in full force and effect.
In order to determine the amortized
cost of the sale of future royalties liability, management is
required to estimate the total amount of future receipts from and
payments to Royalty Pharma under the Royalty Purchase Agreement
over the life of the agreement. The $100,000 liability, recorded at
execution of the Royalty Purchase Agreement, is accreted to the
total of these receipts and payments as interest expense over the
life of the Royalty Purchase Agreement. These estimates contain
assumptions that impact both the amortized cost of the liability
and the interest expense that are recognized in each reporting
period.
Additional proceeds received from
Royalty Pharma will increase the Group's financial liability. As
royalty payments are made to Royalty Pharma, the balance of the
liability will be effectively repaid over the life of the Royalty
Purchase Agreement. To date, the Group has not made any royalty
payments to Royalty Pharma. The estimated timing and amount of
royalty payments to and proceeds from Royalty Pharma are likely to
change over the life of the Royalty Purchase Agreement. A
significant increase or decrease in estimated royalty payments, or
a significant shift in the timing of cash flows, will materially
impact the sale of future royalties liability, interest expense and
the time period for repayment. The Group periodically assesses the
expected payments to, or proceeds from, Royalty Pharma. Any such
changes in amount or timing of cash flows requires the Group to
re-calculate the amortized cost of the sale of future royalties
liability as the present value of the estimated future cash flows
from the Royalty Purchase Agreement that are discounted at the
liability's original effective interest rate. The adjustment is
recognized immediately in profit or loss as income or
expense.
The following shows the activity in
respect of the sale of future royalties liability:
|
Sale of
future royalties liability
$
|
Balance as of December 31,
2023
|
110,159
|
Non cash interest expense
recognized
|
10,551
|
Balance as of June 30,
2024
|
120,710
|
Less sale of future royalties
liability, current
|
-3,252
|
Sale of future royalties liability,
non-current
|
117,458
|
13. Financial Instruments
The Group's financial instruments
consist of financial assets in the form of notes, convertible notes
and investment in shares, and financial liabilities, including
preferred shares. Many of these financial instruments are presented
at fair value, with changes in fair value recorded through profit
and loss.
Fair Value Process
For financial instruments measured
at fair value under IFRS 9, the change in the fair value is
reflected through profit and loss. Using the guidance in IFRS 13,
the total business enterprise value and allocable equity of each
entity being valued can be determined using a market backsolve
approach through a recent arm's length financing round (or a future
probable arm's length transaction), market/asset
probability-weighted expected return method ("PWERM") approach,
discounted cash flow approach, or hybrid approaches. The
approaches, in order of strongest fair value evidence, are detailed
as follows:
Valuation Method
|
Description
|
Market - Backsolve
|
The market backsolve approach
benchmarks the original issue price (OIP) of the company's latest
funding transaction as current value.
|
Market/Asset - PWERM
|
Under a PWERM, the company value is
based upon the probability-weighted present value of expected
future investment returns, considering each of the possible future
outcomes available to the enterprise. Possible future outcomes can
include IPO scenarios, potential SPAC transactions, merger and
acquisition transactions as well as other similar exit transactions
of the investee.
|
Income
Based - DCF
|
The income approach is used to
estimate fair value based on the income streams, such as cash flows
or earnings, that an asset or business can be expected to
generate.
|
At each measurement date,
investments held at fair value (that are not publicly traded) as
well as the fair value of preferred share liabilities, including
embedded conversion rights that are not bifurcated, were determined
using the following allocation methods: option pricing model
("OPM"), PWERM, or hybrid allocation framework. The methods are
detailed as follows:
Allocation Method
|
Description
|
OPM
|
The OPM model treats preferred
stock as call options on the enterprise's equity value, with
exercise prices based on the liquidation preferences of the
preferred stock.
|
PWERM
|
Under a PWERM, share value is based
upon the probability-weighted present value of expected future
investment returns, considering each of the possible future
outcomes available to the enterprise, as well as the rights of each
share class.
|
Hybrid
|
The hybrid method is a combination
of the PWERM and OPM. Under the hybrid method, multiple liquidity
scenarios are weighted based on the probability of the scenario's
occurrence, similar to the PWERM, while also utilizing the OPM to
estimate the allocation of value in one or more of the
scenarios.
|
Valuation policies and procedures
are regularly monitored by the Group. Fair value measurements,
including those categorized within Level 3, are prepared and
reviewed for reasonableness and compliance with the fair value
measurements guidance under IFRS accounting standards. The Group
measures fair value using the following fair value hierarchy that
reflects the significance of the inputs used in making the
measurements:
Fair Value
Hierarchy Level
|
Description
|
Level 1
|
Inputs that are quoted market
prices (unadjusted) in active markets for identical
instruments.
|
Level 2
|
Inputs other than quoted prices
included within Level 1 that are observable either directly (i.e.
as prices) or indirectly (i.e. derived from prices).
|
Level 3
|
Inputs that are unobservable. This
category includes all instruments for which the valuation technique
includes inputs not based on observable data and the unobservable
inputs have a significant effect on the instruments'
valuation.
|
Whilst the Group considers the
methodologies and assumptions adopted in fair value measurements as
supportable and reasonable, because of the inherent uncertainty of
valuation, those estimated values may differ significantly from the
values that would have been used had a ready market for the
investment existed.
Subsidiary Preferred Shares
Liability
The following table summarizes the
changes in the Group's subsidiary preferred shares measured at fair
value, which are categorized as Level 3 in the fair value
hierarchy:
|
Subsidiary Preferred Shares
$
|
Balance at December 31, 2023 and
January 1, 2024
|
169
|
Value at issuance
|
68,100
|
Change in fair value
|
1,613
|
Balance at June 30, 2024
|
69,882
|
The change in fair value of
preferred shares liabilities are recorded in finance income/(costs)
- fair value accounting in the Condensed Consolidated Statement of
Comprehensive Income/(Loss).
The significant unobservable inputs
used at June 30, 2024 in the fair value measurement of the Group's
material subsidiary preferred shares liability and the sensitivity
of the fair value measurement for this liability to changes of
these significant unobservable inputs are summarized in the table
below.
As of June 30, 2024
|
Subsidiary Preferred Share Liability Measured
through
Market
Backsolve & Two-Scenario OPM
|
Unobservable Inputs
|
Input
Value
|
Sensitivity Range
|
Fair Value
Increase/(Decrease) $
|
Equity Value
|
192,200
|
-5%
|
(2,251)
|
|
|
+5%
|
2,137
|
Time to Liquidity
|
1.27
|
-6 Months
|
3,511
|
|
|
+ 6 Months
|
(2,924)
|
Volatility
|
56%
|
-10%
|
1,664
|
|
|
+10%
|
(1,714)
|
Investments Held at Fair
Value
Vor and Akili Valuation
Vor (Nasdaq: VOR), Akili (Nasdaq:
AKLI) and additional immaterial investments are listed entities on
an active exchange, and as such, the fair value as of June 30,
2024, was calculated utilizing the quoted common share price which
is categorized as Level 1 in the fair value hierarchy.
Vedanta and Sonde
As of June 30, 2024, the Group
accounts for the following investments under IFRS 9 as investments
held at fair value with changes in fair value through the profit
and loss: Sonde preferred A-2 and B shares and Vedanta convertible
preferred shares. The valuation of the aforementioned investments
is categorized as Level 3 in the fair value hierarchy due to the
use of significant unobservable inputs to value such assets. During
the six months ended June 30, 2024, the Group recorded such
investments at fair value and recognized a loss of $3,486 for the
change in fair value of the investments.
The following table summarizes the
changes in all the Group's investments held at fair value
categorized as Level 3 in the fair value hierarchy:
|
$
|
Balance at December 31, 2023
|
24,872
|
Gain/(loss) on changes in fair
value
|
(3,796)
|
Balance as of June 30, 2024 before allocation of equity method
loss to LTI
|
21,076
|
Equity method loss recorded against
LTI
|
(172)
|
Balance as of June 30, 2024 after allocation of equity method
loss to LTI
|
20,904
|
The change in fair value of
investments held at fair value is recorded in gain/(loss) on
investments held at fair value in the Condensed Consolidated
Statement of Comprehensive Income/(Loss).
As of June 30, 2024, the Group's
material investments held at fair value categorized as Level 3 in
the fair value hierarchy include the preferred shares of Sonde and
Vedanta, with fair value of $10,571 and $10,505, respectively. The
significant unobservable inputs used at June 30, 2024 in the fair
value measurement of these investments and the sensitivity of the
fair value measurements for these investments to changes of these
significant unobservable inputs are summarized in the table
below.
As of June 30, 2024
|
Investment Measured through
Market
Backsolve & OPM
|
Unobservable Inputs
(Sonde)
|
Input
Value
|
Sensitivity Range
|
Fair Value
Increase/(Decrease) $
|
Equity Value
|
54,307
|
-5%
|
(466)
|
|
|
+5%
|
466
|
Time to Liquidity
|
2.00
|
-6 Months
|
34
|
|
|
+ 6 Months
|
(37)
|
Volatility
|
55%
|
-10%
|
1
|
|
|
+10%
|
(25)
|
As of June 30, 2024
|
Investment Measured through Market Backsolve that Leverages a
Monte Carlo Simulation
|
Unobservable Inputs
(Vedanta)
|
Input
Value
|
Sensitivity Range
|
Fair
Value Increase/(Decrease) $
|
Equity Value
|
30,272
|
-5%
|
(1,029)
|
|
|
+5%
|
913
|
Time to Liquidity
|
0.73
|
- 6 Months
|
(9,690)
|
|
|
+ 6 Months
|
3,328
|
Volatility
|
125%
|
-10%
|
(1,111)
|
|
|
+10%
|
823
|
Investments in Notes from
Associates
As of June 30, 2024 and December
31, 2023, the investment in notes from associates was $16,212 and
$4,600, respectively. The balance represents the fair value of
convertible promissory notes with a principal value of $26,850
issued by Gelesis and convertible debt with a principal value of
$5,000 issued by Vedanta.
During the six months ended June
30, 2024, the Group recorded a gain of $11,612 for the change in
fair value of the notes from associates in the gain/(loss) on
investments in notes from associates within the Condensed
Consolidated Statement of Comprehensive Income/Loss. The gain was
driven by an increase of $11,312 in the fair value of the Gelesis
convertible promissory notes and an increase of $300 in the fair
value of the Vedanta convertible note.
In October 2023, Gelesis ceased
operations and filed a voluntary petition for relief under the
provisions of Chapter 7 of Title 11 of the United States Bankruptcy
Code. Therefore, the Group determined the fair value of the
convertible promissory notes issued by Gelesis to be $0 at December
31, 2023. In June 2024, the Bankruptcy Court approved an executed
agreement for a third party to acquire the remaining net assets of
Gelesis for $15,000. As the only senior secured creditor, the Group
is expected to receive a majority of the proceeds from this sale
after deduction of legal and administrative costs incurred by the
Bankruptcy Court. As of June 30, 2024, these notes were determined
to have a fair value of $11,312.
The convertible debt issued by
Vedanta was valued using a market backsolve approach that leverages
a Monte Carlo simulation. The significant unobservable inputs
categorized as Level 3 in the fair value hierarchy used at June 30,
2024, in the fair value measurement of the convertible debt are the
same as the inputs disclosed above for Vedanta preferred
shares.
Fair Value Measurement and
Classification
The fair value of financial
instruments by category as of June 30, 2024 and December 31,
2023:
|
2024
|
|
Carrying
Amount
|
|
Fair Value
|
|
Financial
Assets
$
|
Financial
Liabilities
$
|
|
Level 1
$
|
Level 2
$
|
Level 3
$
|
Total
$
|
Financial assets3:
|
|
|
|
|
|
|
|
Money
Markets1,2
|
224,361
|
-
|
|
224,361
|
-
|
-
|
224,361
|
Investment in notes from
associates
|
16,212
|
-
|
|
-
|
-
|
16,212
|
16,212
|
Investments held at fair
value
|
29,202
|
-
|
|
8,126
|
-
|
21,076
|
29,202
|
Total financial assets
|
269,775
|
-
|
|
232,487
|
-
|
37,288
|
269,775
|
Financial liabilities:
|
|
|
|
|
|
|
|
Subsidiary preferred
shares
|
-
|
69,882
|
|
-
|
-
|
69,882
|
69,882
|
Share-based liability
awards
|
-
|
3,435
|
|
-
|
-
|
3,435
|
3,435
|
Total financial liabilities
|
-
|
73,317
|
|
-
|
-
|
73,317
|
73,317
|
1. Issued
by a diverse group of corporations, largely consisting of financial
institutions, virtually all of which are investment
grade.
2. Included
within cash and cash equivalents.
3. Excluded
from the table above are short-term investments of
$191,938 that are
classified at amortized cost as of June 30, 2024. The cost of these
short-term investments approximates current fair value.
The Group has a number of financial
instruments that are not measured at fair value in the Condensed
Consolidated Statement of Financial Position. For these instruments
the fair values are not materially different from their carrying
amounts.
|
2023
|
|
Carrying
Amount
|
|
Fair
Value
|
|
Financial
Assets
$
|
Financial
Liabilities
$
|
|
Level
1
$
|
Level
2
$
|
Level
3
$
|
Total
$
|
Financial
assets3:
|
|
|
|
|
|
|
|
Money
Markets1,2
|
156,705
|
-
|
|
156,705
|
-
|
-
|
156,705
|
Note from associate
|
4,600
|
-
|
|
-
|
-
|
4,600
|
4,600
|
Investments held at fair
value
|
317,841
|
-
|
|
292,970
|
-
|
24,872
|
317,841
|
Total financial assets
|
479,146
|
-
|
|
449,675
|
-
|
29,472
|
479,146
|
Financial liabilities:
|
|
|
|
|
|
|
|
Subsidiary preferred
shares
|
-
|
169
|
|
-
|
-
|
169
|
169
|
Share-based liability
awards
|
-
|
4,782
|
|
-
|
-
|
4,782
|
4,782
|
Total financial
liabilities
|
-
|
4,951
|
|
-
|
-
|
4,951
|
4,951
|
1. Issued
by a diverse group of corporations, largely consisting of financial
institutions, virtually all of which are investment
grade.
2. Included
within cash and cash equivalents.
3. Excluded
from the table above are short-term investments of $136,062 that
are classified at amortized cost as of December 31, 2023. The cost
of these short-term investments approximates current fair
value.
14. Non-Controlling Interest
As of June 30, 2024,
non-controlling interests include Entrega, Follica, and Seaport.
Ownership interests of the non-controlling interests in these
entities as of June 30, 2024 were 11.7 percent, 19.9 percent
and 56.4 percent, respectively. As of December 31, 2023,
non-controlling interests include Entrega, and Follica. Ownership
interests of the non-controlling interests in these entities were
11.7 percent, and 19.9 percent, respectively. Non-controlling
interests include the amounts recorded for subsidiary stock
awards.
For the six-months ended June 30,
2024, Seaport issued 950,000 shares of fully vested common stock to
the Group and 3,450,000 shares of common stock to certain officers
and directors, of which 1,227,778 shares are fully vested as of
June 30, 2024. Therefore, the non-controlling interest ownership
percentage is 56.4 percent as of June 30, 2024.
The following table summarizes the
changes in the non-controlling ownership interest in
subsidiaries.
|
Non-Controlling Interest
$
|
Balance at December 31, 2023 and
January 1, 2024
|
(5,835)
|
Share of comprehensive income
(loss)
|
(7,111)
|
Equity settled share-based
payments
|
3,285
|
Expiration of share options in
subsidiary
|
(1)
|
Balance at June 30, 2024
|
(9,661)
|
The following table summarizes the
financial information related to Seaport, the Group's only
subsidiary with significant non-controlling interest as of June 30,
2024.
For the period ended June 30,
2024
|
Non-Controlling Interest
$
|
Statement of Comprehensive Income/(Loss)
|
|
Total revenue
|
-
|
Income/(loss) for the
period
|
(12,332)
|
Total comprehensive income/(loss)
for the period
|
(12,332)
|
Statement of Financial Position
|
|
Total assets
|
102,494
|
Total liabilities
|
79,070
|
Net assets/(liabilities)
|
23,424
|
15. Trade and Other Payables
Information regarding Trade and
other payables was as follows:
As of June 30, 2024 and December
31, 2023
|
2024
$
|
2023
$
|
|
|
Trade payables
|
8,125
|
14,637
|
|
Accrued expenses
|
21,434
|
28,187
|
|
Liability for share-based
awards
|
1,886
|
1,281
|
|
Other
|
1
|
3
|
|
Total trade and other payables
|
31,445
|
44,107
|
|
16.Commitments and Contingencies
The Group is a party to certain
licensing agreements where the Group is licensing IP from third
parties. In consideration for such licenses, the Group has made
upfront payments and may be required to make additional contingent
payments based on developmental and sales milestones and/or royalty
on future sales. As of June 30, 2024, certain milestone events have
not yet occurred, and therefore, the Group does not have a present
obligation to make the related payments in respect of the licenses.
Such milestones are dependent on events that are outside of the
control of the Group, and many of these milestone events are remote
of occurring. Payments in respect of developmental milestones that
are dependent on events that are outside the control of the Group
but are reasonably possible to occur amounted to approximately
$7,371 and $7,371, respectively, as of June 30, 2024 and December
31, 2023. These milestone amounts represent an aggregate of
multiple milestone payments depending on different milestone events
in multiple agreements. The probability that all such milestone
events will occur in the aggregate is remote. Payments made to
license IP represent the acquisition cost of intangible
assets.
The Group was a party to certain
sponsored research arrangements and is a party to arrangements with
contract manufacturing and contract research organizations, whereby
the counterparty provides the Group with research and/or
manufacturing services. As of June 30, 2024 and December 31, 2023,
the noncancellable commitments in respect of such contracts
amounted to approximately $16,827 and $16,422,
respectively.
In March 2024, a complaint was
filed in Massachusetts District Court against the Group alleging
breach of contract with respect to certain payments alleged to be
owed to a previous employee of a Group's subsidiary based on
purported terms of a contract between such individual and the
Group. The Group intends to defend itself vigorously though the
ultimate outcome of this matter and the timing for resolution
remains uncertain. No determination has been made that a loss, if
any, arising from this matter is probable or that the amount of any
such loss, or range of loss, is reasonably estimable.
The Group is involved from
time-to-time in various legal proceedings arising in the normal
course of business. Although the outcomes of these legal
proceedings are inherently difficult to predict, the Group does not
expect the resolution of such legal proceedings to have a material
adverse effect on its financial position or results of operations.
The Group did not book any provisions and did not identify any
contingent liabilities requiring disclosure for any legal
proceedings other than already included above for the six months
ended June 30, 2024.
17.Related Parties Transactions
Related Party Subleases
During 2019, the Group executed a
sublease agreement with a related party, Gelesis. During 2023, the
sublease receivable was written down to $0 as Gelesis ceased
operations and filed for bankruptcy.
The Group recorded $0, and $16 of
interest income with respect to the sublease during the six months
ended June 30, 2024, and 2023, respectively, which is presented
within finance income in the Condensed Consolidated Statement of
Comprehensive Income/(Loss).
Key Management Personnel
Compensation
Key management includes executive
directors and members of the executive management team of the Group
(not including non-executive directors). The key management
personnel compensation of the Group was as follows for the six
months ended June 30:
|
2024
$
|
2023
$
|
For the six months ended June
30
|
Short-term employee
benefits
|
1,872
|
2,230
|
Post-employment benefits
|
44
|
38
|
Termination Benefits
|
140
|
187
|
Share-based payment
expense
|
314
|
(518)
|
Total
|
2,370
|
1,937
|
Short-term employee benefits
include salaries, health care and other non-cash benefits.
Post-employment benefits include 401K contributions from the Group.
Termination benefits include severance pay. Share-based payments
are generally subject to vesting terms over future periods. See
Note 7. Share-based Payments. As of June 30, 2024, the payable due
to the key management employees was $909.
In addition the Group paid
remuneration to non-executive directors in the amounts of $245, and
$213 for the six months ended June 30, 2024, and 2023,
respectively. Also, the Group incurred $147, and $216, of stock
based compensation expense for such non-executive directors for the
six months ended June 30, 2024, and 2023, respectively.
During the six months ended June
30, 2024 and 2023, the Group incurred $5, and $0, respectively, of
expenses paid to related parties.
Convertible Notes Issued to
Directors
Certain related parties of the
Group have invested in convertible notes issued by the Group's
subsidiaries. As of June 30, 2024 and
December 31, 2023, the outstanding related party
notes payable totaled $107 and $104, respectively, including principal and interest. The
notes issued to related parties bear interest rates, maturity
dates, discounts and other contractual terms that are the same as
those issued to outside investors during the same
issuances.
Directors' and Senior Managers'
Shareholdings and Share Incentive Awards
The Directors and senior managers
hold beneficial interests in shares in the following businesses and
sourcing companies as of June 30, 2024:
|
Business name (share
class)
|
Number of shares held as of
June 30, 2024
|
Number of options held as of
June 30, 2024
|
Number of RSUs held as of
June 30, 2024
|
Ownership
interest¹
|
Directors:
|
|
|
|
|
|
Dr Robert Langer
|
Entrega (Common)
|
250,000
|
82,500
|
-
|
4.09%
|
Dr Raju Kucherlapati
|
Enlight (Class B Common)
|
-
|
30,000
|
-
|
3.00%
|
Dr John
LaMattina2
|
Vedanta Biosciences
(Common)
|
25,000
|
15,000
|
-
|
0.25%
|
|
Akili (Common)
|
56,554
|
-
|
-
|
0.07%
|
Senior Managers:
|
|
|
|
|
|
Dr Eric Elenko
|
Seaport Therapeutics
|
950,000
|
-
|
-
|
1.11%
|
1.
Ownership interests as of June 30, 2024 are
calculated on a diluted basis, including issued and outstanding
shares, warrants and options (and written commitments to issue
options) but excluding unallocated shares authorized to be issued
pursuant to equity incentive plans and any shares issuable upon
conversion of outstanding convertible promissory notes.
2.
Dr John LaMattina holds convertible notes
issued by Appeering in the aggregate principal amount of $50,000.
Share holdings in Akili were sold in July 2024 as a result of the
acquisition of Akili by Virtual Therapeutics.
Directors and senior managers hold
10,295,371 ordinary shares and 4.3 percent voting rights of the
Group as of June 30, 2024. This amount excludes options to purchase
1,996,875 ordinary shares. This amount also excludes 4,287,561
shares, which are issuable based on the terms of performance based
RSU awards granted to certain senior managers covering the
financial years 2024, 2023 and 2022, and 355,212 shares, which are
issuable to directors immediately prior to the Group's 2025 Annual
General Meeting of Stockholders, based on the terms of the RSU
awards granted to non-executive directors in 2024. Such shares will
be issued to such senior managers and non-executive directors in
future periods provided that performance and/or service conditions
are met, and certain of the shares will be withheld for payment of
customary withholding taxes.
Other
See Note 6. Investment in Notes
from Associates for details on the notes issued by Gelesis and
Vedanta to the Group.
As of June 30, 2024, the Group has
a receivable from Sonde and Vedanta in the amount of
$930.
See Note 5. Investments in
Associates for details on the execution and termination of the
Merger Agreement with Gelesis.
18. Taxation
Income tax benefit/(expense) is
recorded based on management's estimate of the annual effective
income tax rate which is determined for each jurisdiction and
applied to the interim period pre-tax income/(loss) of each
jurisdiction, respectively. Income tax
benefit/(expense) related to discrete events or transactions are
recorded in the interim period in which the event or transaction
occurs.
For the six months ended June 30,
2024 and 2023, the Group recorded an income tax benefit of $6,147
and an income tax expense of $11,807, respectively, which represented an effective
tax rate of 11.2 percent and negative
85.9 percent, respectively. The income tax
benefit recorded for the six months ended June 30,
2024, primarily related to recognizing an income tax benefit
from generated tax credits, a discrete income tax benefit related
to the capital loss from the Akili investment, partially offset by
a discrete income tax expense related to the mark-to-market
investment adjustments.
19.Subsequent Events
The Group has evaluated subsequent
events after June 30, 2024, up to the date of issuance,
August 28, 2024, of the Condensed Consolidated Financial
Statements, and has not identified any recordable or disclosable
events not otherwise reported in these Condensed Consolidated
Financial Statements or notes thereto.
Directors' responsibility statement
The Board of Directors approved
this Half-yearly Financial Report on August 28,
2024.
The Directors confirm that to the
best of their knowledge the unaudited condensed financial
information has been prepared in accordance with IAS 34 as
contained in UK-adopted International Financial Reporting Standards
(IFRS) and that the interim management report includes a fair
review of the information required by DTR 4.2.7 and DTR
4.2.8.
Approved by the Board of Directors
and signed on its behalf by:
Bharatt Chowrira
Chief Executive Officer
August 28,
2024