Immunocore reports fourth quarter and
full year 2023 financial results and provides a business
update
KIMMTRAK (tebentafusp) net revenues of $67.6
million in Q4 2023 and $238.7 million in 2023; increasing
commercial access to KIMMTRAK globally, and pursuing future growth
opportunities with two registrational trials in advanced cutaneous
melanoma and adjuvant uveal melanoma
Clinical trial collaboration and supply agreement
with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02)
with nivolumab in registrational Phase 3 first-line advanced
cutaneous melanoma trial; PRISM-MEL301 trial to start in 1Q
2024
Multiple clinical readouts expected to start in
2Q 2024 for IMC-F106C from Phase 1/2 clinical trial monotherapy and
combination arms; CTA/IND submission for IMC-P115C (PRAME HLA-A02
HLE) and IMC-T119C (PRAME HLA-A24) programs on track for 2024
IMC-R117C, a first-in-class ImmTAC targeting
PIWIL1, to begin Phase 1 trial in colorectal and other
gastrointestinal cancers in 2H 2024
Data from IMC-M113V Phase 1 clinical trial in
people living with HIV expected in 2H 2024
Advancing novel TCR bispecific clinical
candidates for autoimmune diseases
Cash and cash equivalents of $442.6 million as of
December 31, 2023; subsequent February 2024 Convertible Senior
Notes offering adds $389.3 million net proceeds
Conference call today, February 28th at 8:00 AM
ET, 1:00 PM GMT
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& ROCKVILLE, Md., US, 28 February 2024) Immunocore Holdings plc
(Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage
biotechnology company pioneering and delivering transformative
immunomodulating medicines to radically improve outcomes for
patients with cancer, infectious diseases and autoimmune diseases,
today announced its financial results for the fourth quarter and
year ended December 31, 2023 and provided a business update.
“In the last 5 years, Immunocore has transformed from a research
organization to a revenue-generating, sustainable company,” said
Bahija Jallal, CEO of Immunocore. “We look forward
to the next 5 years, when we maximize the potential of KIMMTRAK,
expect to launch our PRAME ImmTAC therapy, and advance our clinical
candidates across oncology, infectious diseases and autoimmune
diseases."
“Throughout the last year, we expanded the reach of KIMMTRAK in
metastatic uveal melanoma with additional approvals, launches, and
sales growth across all territories,” said Ralph Torbay,
Head of Commercial. “We believe KIMMTRAK, the world’s
first approved TCR therapy, could benefit thousands more patients
and look forward to broadening indications with ongoing late-stage
clinical trials in cutaneous and adjuvant uveal melanoma.”
Full Year and Fourth Quarter 2023
Highlights (including post-period)
Financial Results
Total net product revenue (or “net sales)
arising from the sales of KIMMTRAK (tebentafusp) was $67.6 million
in the fourth quarter of 2023, of which $49.1 million was generated
in the United States, $18.3 million in Europe and $0.2 million in
international regions. For the year ended December 31, 2023, the
Company generated net sales from the sale of KIMMTRAK in the amount
of $238.7 million, of which $169.8 million was in the United
States, $67.6 million in Europe and $1.3 million in international
regions.
Research & development expenses for the year
2023 were $163.5 million, compared to $101.9 million for the year
2022. Selling, general and administrative (SG&A) expenses for
the year 2023 were $144.5 million, compared to $123.1 million for
the year 2022.
Net loss for the fourth quarter of 2023 was
$19.7 million compared to a net loss of $30.0 million in the same
period in 2022, and full year net loss for 2023 was $55.3 million
compared to a full year net loss of $52.5 million in 2022.
The fourth quarter basic and diluted loss per
share was $0.40, compared to $0.64 for the fourth quarter of 2022.
Basic and diluted loss per share for 2023 was $1.13, compared to
$1.15 for 2022.
Cash and cash equivalents at December 31, 2023
were $442.6 million. In February 2024, the Company raised net cash
proceeds of $389.3 million from an offering of convertible notes
with a six-year term and 2.50% interest rate (Convertible
Notes).
KIMMTRAK expansion strategy
KIMMTRAK® (tebentafusp-tebn) for metastatic uveal
melanoma
Since the start of the 2024, KIMMTRAK has been
launched in two additional countries (Australia and Canada), for a
total of 12 launched and 38 approved countries. KIMMTRAK continues
to be the standard of care for HLA-A02+ patients with metastatic
uveal melanoma (mUM) in all of the countries in which it has been
launched. In 2024, the Company plans to reach more patients in the
United States, Europe and globally, as it continues to drive global
launches and focuses on supporting early patient identification and
treatment.
KIMMTRAK Phase 2/3 clinical trial in 2L+ advanced
cutaneous melanoma
The Company also continues to enroll patients
into a Phase 2/3 clinical trial (TEBE-AM) to investigate the
potential of KIMMTRAK in 2L+ advanced cutaneous melanoma. Topline
data from the Phase 2 portion of the trial is expected to be
available by the fourth quarter of 2024.
KIMMTRAK Phase 3 clinical trial in adjuvant uveal (or
ocular) melanoma
In 2023, the Company signed an agreement for a
European Organisation for Research and Treatment of Cancer
(EORTC)-sponsored trial to study KIMMTRAK as adjuvant therapy for
uveal (or ocular) melanoma (ATOM). The Company anticipates that the
EORTC will randomize the first patient in the second half of
2024.
PRAME franchise
PRISM-MEL301 – First PRAME Phase 3
clinical trial with IMC-F106C in first-line advanced cutaneous
melanoma
In February 2024, the Company entered into a
clinical trial collaboration and supply agreement with Bristol
Myers Squibb (NYSE:BMY) to investigate Immunocore’s ImmTAC
bispecific TCR candidate targeting PRAME HLA-A02, IMC-F106C, in
combination with Bristol Myers Squibb’s nivolumab, in first-line
advanced cutaneous melanoma. Under the terms of the collaboration,
Immunocore will sponsor and fund the registrational Phase 3
clinical trial of IMC-F106C in combination with nivolumab in
first-line advanced cutaneous melanoma (PRISM-MEL-301), and Bristol
Myers Squibb will provide nivolumab.
In August 2023, the Company announced plans to
start a registrational Phase 3 clinical trial with IMC-F106C in
first-line advanced cutaneous melanoma (CM). The Company decided to
advance IMC-F106C into a Phase 3 first-line CM clinical trial in
combination with nivolumab with a primary endpoint of
progression-free survival (PFS), based on the Company’s analysis of
the ongoing Phase 1 data in previously treated CM which
demonstrated monotherapy clinical activity including partial
responses (PR), durable tumor reduction, disease control (PR and
SD), PFS and circulating tumor DNA (ctDNA) reduction (consistent
with prior reported data for IMC-F106C and tebentafusp). Additional
rationale includes safety in combination with checkpoints (from the
ongoing Phase 1 data and prior experience with tebentafusp) and
evidence from across the platform for increased clinical activity
in earlier line patients compared to later line. As such,
PRISM-MEL-301, the first PRAME Phase 3 clinical trial with
IMC-F106C, will randomize patients with HLA-A*02:01-positive,
first-line advanced CM to IMC-F106C + nivolumab versus a control
arm of either nivolumab or nivolumab + relatlimab, depending on the
country where the patient is enrolled. The Company plans to
randomize the first patient in this trial in the first quarter of
2024.
Phase 1/2 clinical trial of IMC-F106C
targeting PRAME-A02 in multiple solid tumors
In addition to progressing IMC-F106C into a
registrational trial in cutaneous melanoma, the Company is
continuing to enroll patients in the monotherapy and combination
arms of the Phase 1/2 clinical trial across multiple tumor types,
including expansion arms for patients with advanced ovarian,
non-small cell lung, and endometrial carcinoma. The initial data
from the Phase 1 clinical trial of IMC-F106C, the first PRAME x CD3
ImmTAC bispecific protein, was presented at the 2022 European
Society for Medical Oncology (ESMO) Congress in September 2022.
Durable Response Evaluation Criteria in Solid Tumors (RECIST)
responses and reduction in ctDNA were observed across multiple
solid tumors. In August 2023, the Company provided an updated
analysis of the original 18 melanoma patients (initially presented
at ESMO in September 2022), which continued to show promising
durability of the clinical activity (range of duration of partial
response from 6 months to 17 months). The Company expects to report
clinical data from the ongoing monotherapy and combination cohorts
throughout 2024 including cutaneous melanoma (expected in Q2 2024),
ovarian (expected by Q3 2024), and non-small cell lung carcinoma
(expected by Q4 2024).
IMC-P115C (PRAME HLA-A02 Half-Life
Extended) & IMC-T119C (PRAME HLA-A24)
The Company is expanding the PRAME franchise with two new PRAME
ImmTAC candidates, IMC-P115C (PRAME HLA-A02 HLE) and IMC-T119C
(PRAME HLA-A24) for solid tumors, which are both on track for
investigational new drug (IND) or clinical trial application (CTA)
submissions for IMC-P115C in the middle of 2024 and the fourth
quarter of 2024 for IMC-T119C.
IMC-R117C (PIWIL1) for colorectal and
other gastrointestinal cancers
The Company has leveraged its proprietary
peptide (ImmSPECT) database to validate a novel target, PIWIL1.
PIWIL1 is believed to play a role in tumor progression and is
expressed across a range of tumors, including colorectal which is
historically insensitive to immune checkpoints, as well as other
gastrointestinal cancers. PIWIL1 is also reported to be a negative
prognostic marker and the Company believes IMC-R117C is the first
PIWIL1-targeted immunotherapy. The Company submitted a CTA to
regulatory authorities in December 2023, and expects the trial to
start in the second half of 2024.
Enrolling ImmTAV candidates for a
functional cure in infectious diseases
The Company continues to enroll people living
with HIV in the multiple ascending dose (MAD) part of a Phase 1
clinical trial with IMC-M113V, to identify a safe and tolerable
dosing schedule. This trial will also test whether IMC-M113V could
lead to reduction in the viral reservoir and, after stopping all
therapies (antiretroviral therapies and IMC-M113V), delay or
prevent HIV rebound (known as functional cure). The MAD part of the
trial will enroll up to 28 participants. The Company expects to
present a data update from the Phase 1 clinical trial in the second
half of 2024.
In 2023, the Company amended the design of the ongoing Phase 1
clinical trial with IMC-I109V for people living with HBV to include
HBV-positive hepatocellular carcinoma. The Company continues to
enroll patients into the single ascending dose portion of the trial
in 2024.
Tissue-specific down modulation of the
immune system for autoimmune diseases
The Company is expanding its platform into
autoimmune diseases with two first-in-class new bispecific
candidates entering the Company’s pipeline. The key differentiator
of the ImmTAAI platform is tissue-specific down modulation of the
immune system. When tethered to the tissue of interest, the new
candidates supress pathogenic T cells via PD1 receptor agonism.
The first candidate, IMC-S118AI (PPIxPD1), is
targeted specifically to pancreatic beta cells and is intended for
disease-modifying treatment in type 1 diabetes. IMC-S118AI
recognizes a peptide from pre-proinsulin presented by HLA-A02 on
beta cells coupled with a PD1 agonist effector arm. IMC-S118AI is
advancing towards GMP manufacturing in 2024.
The second target is present in the skin and
intended to treat inflammatory dermatological diseases. The
candidate is an antigen presenting cell (APC) tethered ImmTAAI and
is not HLA restricted (e.g. universal for all populations).
Financial Results
Basic and diluted loss per share was $0.40 and
$1.13 for the quarter and year ended December 31, 2023,
respectively, as compared to a basic and diluted loss per share of
$0.64 and $1.15, respectively, for the same periods in 2022. Net
loss for the quarter and year ended December 31, 2023, was $19.7
million and $55.3 million, respectively, as compared to $30.0
million and $52.5 million, respectively, for the same periods in
2022.
For the fourth quarter and year ended December
31, 2023, we generated net sales of $67.6 million and $238.7
million, respectively, due to the sale of KIMMTRAK and tebentafusp,
of which $49.1 million and $169.8 million, respectively was in the
United States, $18.3 million and $67.6 million, respectively, was
in Europe, and $0.2 million and $1.3 million, respectively, was in
the international regions. The increase in net sales was due
primarily to increased volume in the United States and global
country expansion, as we continued our commercialization
efforts.
For the fourth quarter and year ended December
31, 2023, our research and development (R&D) expenses were
$45.6 million and $163.5 million, respectively as compared to $31.1
million and $101.9 million for the quarter and year ended December
31, 2022. These increases were driven by expenses incurred for our
PRAME programs, increases in headcount-related expenses as a result
of higher number of employees and associated staff costs, increases
related to consumables and facilities costs, and decreased R&D
tax credits due to us no longer qualifying as a ‘small and medium
enterprise’ (SME) under the UK R&D tax regulations. The Company
expects R&D expenses to increase in future periods as the
Company advances its trials and further develops clinical and
preclinical pipeline candidates.
For the quarter and year ended December 31,
2023, our SG&A expenses were $41.4 million and $144.5 million,
respectively, compared to $35.4 million and $123.1 million for the
quarter and year ended December 31, 2022. These increases were
related to an increase in headcount costs, higher selling and
distribution costs following regulatory approval of KIMMTRAK, and
costs associated with expansion as a growing publicly listed and
commercial company.
Cash and cash equivalents were $442.6 million as
of December 31, 2023, as compared to $402.5 million as of December
31, 2022. In February 2024, the Company raised net cash proceeds of
$389.3 million from a Convertible Notes offering with a six-year
term and 2.50% interest rate. The Company plans to use $50 million
from the net proceeds to repay its existing Pharmakon loan by the
end of 2024. The Company estimates Pro Forma for the net cash
proceeds from the Convertible Notes offering in February 2024, and
the Pharmakon loan repayment, its cash and cash equivalents at
year-end 2023, were approximately $782 million.
As of December 31, 2023, the Company no longer
qualified as a foreign private issuer for U.S. publicly company
reporting purposes. Effective January 1, 2024, it now files
periodic reports on U.S. domestic filer forms with the Securities
and Exchange Commission (SEC) and comply with other rules as
required, including but not limited to presenting its financial
results in press releases and Annual Report on Form 10-K in
accordance with U.S. GAAP, with such change being applied
retrospectively. See the Company’s Annual Report on Form 10-K filed
today with the SEC for more information.
Audio Webcast
Immunocore will host a conference call today,
February 28, 2024 at 8:00 A.M. ET/ 1:00 PM GMT, to discuss the
fourth quarter and full year 2023 financial results and provide a
business update. The call will also be available via webcast by
visiting the Events & Presentations section on Immunocore’s
website. A replay of this webcast will be available for 30
days.
Conference Call Details:U.S. (toll-free):
877-405-1239International (toll): +1 201-389-0851
##
About ImmTAC® molecules for
cancerImmunocore’s proprietary T cell receptor (TCR)
technology generates a novel class of bispecific biologics called
ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules
that are designed to redirect the immune system to recognize and
kill cancerous cells. ImmTAC molecules are soluble TCRs engineered
to recognize intracellular cancer antigens with ultra-high affinity
and selectively kill these cancer cells via an anti-CD3
immune-activating effector function. Based on the demonstrated
mechanism of T cell infiltration into human tumors, the ImmTAC
mechanism of action holds the potential to treat hematologic and
solid tumors, regardless of mutational burden or immune
infiltration, including immune “cold” low mutation rate tumors.
About ImmTAV molecules and infectious
diseasesImmTAV (Immune mobilising monoclonal TCRs Against
Virus) molecules are novel bispecifics that, like ImmTAC (Immune
mobilising monoclonal TCRs Against Cancer) molecules, are designed
to enable the immune system to recognize and eliminate virally
infected cells.
Immunocore is advancing clinical candidates to
cure patients with HIV and hepatitis B virus (HBV). The Company
aims to achieve sustained control of HIV after patients stop
anti-retroviral therapy (ART), without the risk of virological
relapse or onward transmission. This is known as ‘functional cure’.
For the treatment of HBV, the Company aims to achieve sustained
loss of circulating viral antigens and markers of viral replication
after stopping medication for people living with chronic HBV.
About ImmTAAI molecules and autoimmune
diseases ImmTAAI (Immune mobilising monoclonal TCRs
Against Autoimmune) molecules are novel bispecifics that are
designed for tissue-specific down modulation of the immune system.
When tethered to the tissue of interest, ImmTAAI candidates supress
pathogenic T cells via PD1 receptor agonism. The Company is
currently advancing two candidates for autoimmune conditions,
including Type 1 Diabetes and inflammatory dermatological
diseases.
About PRISM-MEL301 – Phase 3 trial with
IMC-F106C (PRAMExCD3) in 1L advanced cutaneous melanomaThe
Phase 3 registrational trial will randomize patients with
previously untreated, HLA-A*02:01-positive, advanced melanoma to
IMC-F106C + nivolumab versus nivolumab or nivolumab + relatlimab,
depending on the country where the patient is enrolled. The study
will initially randomize to three arms: two IMC-F106C dose regimens
(40 mcg and 160 mcg) and control arm and will discontinue one of
the IMC-F106C dose regimens after an initial review of the first 60
patients randomized to the two experimental arms (90 patients
randomized total). The primary endpoint of the trial is progression
free survival (PFS) by blinded independent central review (BICR),
with secondary endpoints of overall survival (OS) and overall
response rate (ORR).
About the IMC-F106C-101 Phase 1/2
trialIMC-F106C-101 is a first-in-human, Phase 1/2 dose
escalation trial in patients with multiple solid tumor cancers
including non-small cell lung cancer (NSCLC), small-cell lung
cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast
cancers. The Phase 1 dose escalation trial was designed to
determine the maximum tolerated dose (MTD), as well as to evaluate
the safety, preliminary anti-tumor activity and pharmacokinetics of
IMC-F106C, a bispecific protein built on Immunocore’s ImmTAC
technology, and the Company’s first molecule to target the PRAME
antigen. The Company has initiated patient enrollment into four
expansion arms in cutaneous melanoma, ovarian, NSCLC, and
endometrial carcinomas. The IMC-F106C-101 trial is adaptive and
includes the option for Phase 2 expansion, allowing for
approximately 100 patients treated per tumor type in the Phase 1
and 2 expansion arms. Dose escalation continues in additional solid
tumors as well as plans for combination arms with
standards-of-care, including checkpoint inhibitors, chemotherapy,
and tebentafusp.
About TEBE-AM - Phase 2/3 trial with
tebentafusp (gp100xCD3) in second-line or later cutaneous
melanomaThe trial is randomizing patients with second-line
or later cutaneous melanoma who have progressed on an anti-PD1,
received prior ipilimumab and, if applicable, received a BRAF
kinase inhibitor. Patients will be randomized to one of three arms
including tebentafusp, as monotherapy or in combination with an
anti-PD1, and a control arm. The Phase 2 portion of the trial will
include 40 patients per arm.
About the ATOM Phase 3 trial
The EORTC-led Phase 3 clinical trial will include sites in 10 EU
countries and the United States and will randomize patients with
HLA-A*02:01-positive high-risk primary uveal melanoma after
definitive treatment, by surgery or radiotherapy, and no evidence
of metastatic disease on imaging. The trial is expected to enroll a
total of 290 patients who will be randomized 1:1 to one of two
arms: KIMMTRAK as monotherapy or observation. The primary endpoint
of the trial is relapse-free survival (RFS), with secondary
objectives of overall survival and safety and tolerability of
tebentafusp. Exploratory objectives include the comparison of the
health-related quality of life between the treatment arms and the
evaluation of the role of circulating tumor DNA as a biomarker for
the presence of residual disease.
About Uveal MelanomaUveal
melanoma is a rare and aggressive form of melanoma, which affects
the eye. Although it is the most common primary intraocular
malignancy in adults, the diagnosis is rare, and up to 50% of
people with uveal melanoma will eventually develop metastatic
disease. Unresectable or metastatic uveal melanoma typically has a
poor prognosis and had no approved treatment until KIMMTRAK.
About KIMMTRAK®KIMMTRAK is a
novel bispecific protein comprised of a soluble T cell receptor
fused to an anti-CD3 immune-effector function. KIMMTRAK
specifically targets gp100, a lineage antigen expressed in
melanocytes and melanoma. This is the first molecule developed
using Immunocore’s ImmTAC technology platform designed to redirect
and activate T cells to recognise and kill tumour cells. KIMMTRAK
has been approved for the treatment of HLA-A*02:01-positive adult
patients with unresectable or metastatic uveal melanoma in the
United States, European Union, Canada, Australia, and the United
Kingdom.
IMPORTANT SAFETY
INFORMATION
Cytokine Release Syndrome (CRS), which
may be serious or life-threatening, occurred in patients receiving
KIMMTRAK. Monitor for at least 16 hours following first three
infusions and then as clinically indicated. Manifestations
of CRS may include fever, hypotension, hypoxia, chills, nausea,
vomiting, rash, elevated transaminases, fatigue, and headache. CRS
occurred in 89% of patients who received KIMMTRAK with 0.8% being
grade 3 or 4. Ensure immediate access to medications and
resuscitative equipment to manage CRS. Ensure patients are
euvolemic prior to initiating the infusions. Closely monitor
patients for signs or symptoms of CRS following infusions of
KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level
and provide appropriate therapy. Withhold or discontinue KIMMTRAK
depending on persistence and severity of CRS.
Skin Reactions
Skin reactions, including rash, pruritus, and
cutaneous edema occurred in 91% of patients treated with KIMMTRAK.
Monitor patients for skin reactions. If skin reactions occur, treat
with antihistamine and topical or systemic steroids based on
persistence and severity of symptoms. Withhold or permanently
discontinue KIMMTRAK depending on the severity of skin
reactions.
Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of
patients treated with KIMMTRAK. Monitor alanine aminotransferase
(ALT), aspartate aminotransferase (AST), and total blood bilirubin
prior to the start of and during treatment with KIMMTRAK. Withhold
KIMMTRAK according to severity.
Embryo-Fetal ToxicityKIMMTRAK
may cause fetal harm. Advise pregnant patients of potential risk to
the fetus and patients of reproductive potential to use effective
contraception during treatment with KIMMTRAK and 1 week after the
last dose.
The most common adverse reactions (≥30%) in
patients who received KIMMTRAK were cytokine release syndrome,
rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain,
edema, hypotension, dry skin, headache, and vomiting. The most
common (≥50%) laboratory abnormalities were decreased lymphocyte
count, increased creatinine, increased glucose, increased AST,
increased ALT, decreased hemoglobin, and decreased phosphate.
For more information, please see full Summary of
Product Characteristics (SmPC) or full U.S. Prescribing Information
(including BOXED WARNING for CRS).
About KIMMTRAKConnectImmunocore
is committed to helping patients who need
KIMMTRAK obtain access via our KIMMTRAKConnect program. The program
provides services with dedicated nurse case managers who provide
personalized support, including educational resources, financial
assistance, and site of care coordination. To learn more, visit
KIMMTRAKConnect.com or call 844-775-2273.
About ImmunocoreImmunocore is a
commercial-stage biotechnology company pioneering the development
of a novel class of TCR bispecific immunotherapies called ImmTAX –
Immune mobilizing monoclonal TCRs Against X disease – designed to
treat a broad range of diseases, including cancer, autoimmune, and
infectious disease. Leveraging its proprietary, flexible,
off-the-shelf ImmTAX platform, Immunocore is developing a deep
pipeline in multiple therapeutic areas, including five clinical
stage programs in oncology and infectious disease, advanced
pre-clinical programs in autoimmune disease and multiple earlier
pre-clinical programs. The Company’s most advanced oncology TCR
therapeutic, KIMMTRAK has been approved for the treatment of
HLA-A*02:01-positive adult patients with unresectable or metastatic
uveal melanoma in the United States, European Union, Canada,
Australia, and the United Kingdom.
Forward Looking Statements This press
release contains “forward-looking statements” within the meaning of
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Words such as “may”, “will”, “believe”,
“expect”, “plan”, “anticipate” and similar expressions (as well as
other words or expressions referencing future events or
circumstances) are intended to identify forward-looking statements.
All statements, other than statements of historical facts, included
in this press release are forward-looking statements. These
statements include, but are not limited to, statements regarding
the commercial performance of KIMMTRAK, including expanded access
to KIMMTRAK to more patients in the United States, Europe and
globally; the potential benefits and advantages KIMMTRAK will
provide for patients, including its potential for expansion into
other indications such as cutaneous and adjuvant uveal melanoma;
expectations regarding the design, progress, timing, enrollment,
randomization, scope, expansion, funding, and results of the
Company’s existing and planned clinical trials, those of the
Company’s collaboration partners or the combined clinical trials
with the Company’s collaboration partners; statements regarding the
benefits of the Company’s collaboration with Bristol-Meyers Squibb;
the timing and sufficiency of clinical trial outcomes to support
potential approval of any of the Company’s product candidates or
those of, or combined with, its collaboration partners; the
Company’s goals to develop and commercialize product candidates
based on its KIMMTRAK platform alone or with collaboration
partners; the expected submission of investigational new drug
applications or clinical trial applications; the potential
regulatory approval, expected clinical benefits and availability of
the Company’s product candidates; the use of proceeds from the
Convertible Notes offering; and the Company’s expectations
regarding its cash runway. Any forward-looking statements are based
on management’s current expectations and beliefs of future events
and are subject to a number of risks and uncertainties that could
cause actual events or results to differ materially and adversely
from those set forth in or implied by such forward-looking
statements, many of which are beyond the Company’s control. These
risks and uncertainties include, but are not limited to, the impact
of worsening macroeconomic conditions on the Company’s business,
financial position, strategy and anticipated milestones, including
Immunocore’s ability to conduct ongoing and planned clinical
trials; Immunocore’s ability to obtain a clinical supply of current
or future product candidates or commercial supply of KIMMTRAK or
any future approved products, including as a result of health
epidemics or pandemics, war in Ukraine, the conflict between Hamas
and Israel, or global geopolitical tension; Immunocore’s ability to
obtain and maintain regulatory approval of its product candidates,
including KIMMTRAK; Immunocore’s ability and plans in continuing to
establish and expand a commercial infrastructure and to
successfully launch, market and sell KIMMTRAK and any future
approved products; Immunocore’s ability to successfully expand the
approved indications for KIMMTRAK or obtain marketing approval for
KIMMTRAK in additional geographies in the future; the delay of any
current or planned clinical trials, whether due to patient
enrollment delays or otherwise; Immunocore’s ability to
successfully demonstrate the safety and efficacy of its product
candidates and gain approval of its product candidates on a timely
basis, if at all; competition with respect to market opportunities;
unexpected safety or efficacy data observed during preclinical
studies or clinical trials; actions of regulatory agencies, which
may affect the initiation, timing and progress of clinical trials
or future regulatory approval; Immunocore’s need for and ability to
obtain additional funding, on favorable terms or at all, including
as a result of worsening macroeconomic conditions, including
changes inflation and interest rates and unfavorable general market
conditions, and the impacts thereon of the war in Ukraine, the
conflict between Hamas and Israel, and global geopolitical tension;
Immunocore’s ability to obtain, maintain and enforce intellectual
property protection for KIMMTRAK or any of its product candidates
it or its collaborators are developing; and the success of
Immunocore’s current and future collaborations, partnerships or
licensing arrangements, including the risk that Immunocore may not
realize the anticipated benefits of its collaboration with Bristol
Myers Squibb. These and other risks and uncertainties are described
in greater detail in the section titled "Risk Factors" in
Immunocore’s filings with the Securities and Exchange Commission,
including Immunocore’s most recent Annual Report on Form 10-K for
the year ended December 31, 2023 filed with the Securities and
Exchange Commission on February 28, 2024, as well as discussions of
potential risks, uncertainties, and other important factors in the
Company’s subsequent filings with the SEC. All information in this
press release is as of the date of the release, and the Company
undertakes no duty to update this information, except as required
by law.
CONTACT: Immunocore
Sébastien Desprez, Head of CommunicationsT: +44 (0) 7458030732E:
sebastien.desprez@immunocore.com Follow
on Twitter: @Immunocore
Investor Relations Clayton Robertson,
Head of Investor RelationsT: +1 215-384-4781E:
ir@immunocore.com
Immunocore Holdings PLC |
|
Consolidated Statement of Operations |
|
Comparison of the Years ended December 31, 2023 and
2022 |
$'000 |
|
|
Quarter Ended |
|
Year Ended |
|
December 31, 2023 |
December 31, 2022 |
|
December 31, 2023 |
December 31, 2022 |
Product revenue |
$ |
67,592 |
$ |
51,506 |
|
$ |
238,735 |
$ |
130,013 |
Pre-product revenue |
|
(1,084) |
|
- |
10,674 |
Total revenue from sale of
therapies |
67,592 |
50,422 |
|
238,735 |
140,687 |
Collaboration revenue |
2,570 |
6,890 |
|
10,693 |
33,674 |
Total
revenue |
70,162 |
57,312 |
|
249,428 |
174,361 |
Cost of product revenue |
(200) |
(131) |
|
(1,037) |
(1,089) |
Research and development
costs |
(45,565) |
(31,144) |
|
(163,545) |
(101,921) |
Selling, general, &
administrative exps |
(41,449) |
(35,392) |
|
(144,495) |
(123,059) |
Operating
loss |
(17,052) |
(9,355) |
|
(59,649) |
(51,708) |
Interest income |
5,439 |
2,916 |
|
17,986 |
3,756 |
Interest expense |
(1,308) |
(1,518) |
|
(5,154) |
(5,409) |
Foreign currency (loss)
gain |
(12,529) |
(14,206) |
|
(13,176) |
14,157 |
Other expense, net |
(191) |
(1,686) |
|
(897) |
(1,679) |
Net loss before income
taxes |
(25,641) |
(23,849) |
|
(60,890) |
(40,883) |
Income tax
credit/(expense) |
5,911 |
(6,172) |
|
5,603 |
(11,660) |
Net loss |
$ |
(19,730) |
$ |
(30,021) |
|
$ |
(55,287) |
$ |
(52,543) |
|
|
|
|
|
|
Net loss per
share |
$ |
(0.40) |
$ |
(0.63) |
|
$ |
(1.13) |
$ |
(1.15) |
|
|
|
|
|
|
Basic weighted average number
of shares |
49,533,622 |
48,000,101 |
|
48,888,975 |
45,714,923 |
Consolidated Balance Sheets |
As of
December 31, |
$'000 |
|
2023 |
2022 |
ASSETS |
|
|
Current
assets |
|
|
Cash and cash equivalents |
$ |
442,626 |
$ |
402,472 |
Accounts receivable, net |
52,093 |
33,584 |
Prepaid expenses and other
current assets |
29,600 |
37,229 |
Inventory |
4,501 |
692 |
Total current
assets |
528,820 |
473,977 |
Property, plant and equipment,
net |
9,215 |
7,833 |
Operating lease, right of use
assets, net |
33,520 |
30,944 |
Deferred tax assets, net |
10,973 |
5,121 |
Other non-current assets |
14,473 |
8,887 |
Total
assets |
$ |
597,001 |
$ |
526,762 |
|
|
|
Liabilities and
shareholders’ equity |
|
|
Current
liabilities |
|
|
Accounts payables |
$ |
17,798 |
$ |
14,450 |
Accrued expenses & other
current liabilities |
119,835 |
76,747 |
Deferred revenue, current |
- |
7,756 |
Operating lease liabilities,
current |
1,388 |
1,882 |
Total current
liabilities |
139,021 |
100,835 |
Accrued expenses,
non-current |
978 |
2,215 |
Deferred revenue,
non-current |
5,515 |
5,242 |
Operating lease liabilities,
non-current |
34,633 |
31,760 |
Interest-bearing loans and
borrowings |
48,011 |
47,807 |
Total
liabilities |
228,158 |
187,859 |
|
|
|
Shareholders'
equity |
|
|
Common stock |
134 |
129 |
Deferred stock |
1 |
1 |
Additional paid-in
capital |
1,149,643 |
1,082,833 |
Accumulated deficit |
(744,674) |
(689,387) |
Accumulated other
comprehensive income |
(36,261) |
(54,673) |
Total shareholders'
equity |
368,843 |
338,903 |
Total liabilities and
shareholders' equity |
$ |
597,001 |
$ |
526,762 |
Summary Consolidated Statement of Cash
FlowsFor the Years Ended December
31, |
|
|
$'000 |
|
|
|
|
|
|
2023 |
2022 |
|
|
|
Cash and cash equivalents, beg
of year |
$ |
402,472 |
$ |
321,082 |
Net cash provided by (used in)
operating activities |
2,940 |
(49,209) |
Net cash (used in) investing
activities |
(5,425) |
(2,197) |
Net cash provided by financing
activities |
34,346 |
145,442 |
Net foreign exchange
difference on cash held |
8,293 |
(12,646) |
Cash and cash
equivalents, end of year |
$ |
442,626 |
$ |
402,472 |
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