Innovent Announces 2024 Interim Results and Business Updates
PR Newswire
SAN FRANSISCO and SUZHOU, China, Aug. 28, 2024
Strong commercial performance and significant pipeline milestones
support sustained growth and innovation
SAN FRANSISCO and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2024 interim results and major business updates.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "For the first half of 2024, our company's strategy of sustainable growth and global innovation continue executing very well: we achieved strong revenue growth, improved operational efficiency in all areas, and reached significant milestones in our late-stage pipeline to support our sustained growth. We also reported promising data readouts from early-stage assets, reinforcing our confidence in achieving global innovation and contributing to new long-term opportunities. The successful first half of 2024 has laid a solid foundation for achieving our full-year's growth. With strong commercial and financial execution, a high-value late-stage pipeline, and disciplined investments in next-generation innovation, we are well-positioned to deliver long-term value for patients, employees, shareholders and society."
Enhanced operational efficiency and strong financial performance
-- Strong revenue growth momentum: total revenue was RMB3,952.3 million in
the first half of 2024, with a strong year-over-year growth of 46.3%,
reflecting robust demand for our innovative portfolio and the advantage
of our sustainable business model.
-- Significantly improved financial performance: EBITDA Loss was
significantly reduced, driven by strong revenue growth, enhanced
operational efficiency and notable financial improvement.
-- The gross profit margin of total revenue was 84.1%, a
year-over-year increase of 1.8 percentage points
-- The selling and marketing expenses of product revenue was 48.6%, a
year-over-year decrease of 5.9 percentage points
-- The administration and expenses of total revenue was 5.2%, a
year-over-year decrease of 4.9 percentage points
-- R&D expenses were RMB1,293.9 million; cash and short-term
financial assets were RMB10,112.3 million, or approximately over
USD1.4 billion, which enables us to focus on the long-term
sustainable development
-- EBITDA loss was RMB160.8 million, a notable year-over-year
decrease of 39.9%
Note: The financial numbers mentioned above were based on non-IFRS measure.
Detailed disclosure can be found at the Company's 2024 interim results
announcement.
Strong product revenue growth; preparing for CVM commercialization
-- Product sales revenue reached RMB3,811.4 million in the first half of
2024, a strong year-over-year growth of 55.1%.
-- Expansion of commercial portfolio into new approved products, new
indications and broader NRDL coverage[1],[2] and patient access:
-- Eleven approved products: TYVYT$(R)$, BYVASDA(R), SULINNO(R),
HALPRYZA(R), PEMAZYRE(R), Olverembatinib, CYRAMZA(R), Retsevmo(R),
FUCASO(R) , SINTBILO(R) and DUPERT(R) (new product, KRAS G12C
inhibitor) .
-- TYVYT(R) and PEMAZYRE(R) were newly approved in the Macau market.
-- TYVYT(R) and BYVASDA(R) were included in the NRDL for the
treatment of EGFR-mutated NSCLC.
-- Solidify oncology leadership; in active preparation for new commercial
opportunities in general biomedicine.
-- Oncology: we strengthened our leadership with a robust product
portfolio, including TYVYT(R) (sintilimab injection), and expanded
out oncology business with a 10th product, a ROS1 inhibitor, set
for approval in the second half of 2024.
-- General biomedicines: Following the approval of the first CVM
product SINTBILO(R) (tafolecimab injection) in 2023, we have
successfully submitted three new drug applications (NDA)--two for
mazdutide, targeting obesity/overweight population and T2D, and
one for IBI311 (IGF-1R) for thyroid eye disease (TED). As a key
strategic priority, we are steadily building our commercialization
capabilities in the CVM field with systematic approaches, aiming
to unlock substantial commercial opportunities and drive
sustainable growth.
Material innovation delivery supports strategic goals
7 new assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early-phase clinical studies
Substantial milestones delivered for key late-stage assets
-- Encouraging progress in the next wave innovation of "IO+ADC"
-- TYVYT(R) (sintilimab): submitted an NDA for its eighth indication,
2L endometrial cancer $(EMC.AU)$. New registrational clinical trials
for neoadjuvant therapy in colon cancer and perioperative therapy
in NSCLC have been initiated. Additionally, we are exploring the
potential of combination therapies through multiple collaborations
with novel modalities.
-- IBI310 (CTLA-4) initiated a Phase 3 clinical trial for IBI310 in
combination with sintilimab as neoadjuvant therapy in treating
colon cancer.
-- IBI343 (CLDN18.2 ADC) Phase 1b positive data readout in GC and a
Phase 3 trial is in preparation.
-- Accelerating new launch momentum in general biomedicine to unlock
significant opportunities
-- Mazdutide (GLP-1R/GCGR) : first NDA for weight management in obese
or overweight populations and second NDA for T2D treatment, both
under NMPA review. We plan to develop new indications, including
adolescent obesity, metabolic dysfunction-associated
steatohepatitis (MASH), obstructive sleep apnea (OSA), and heart
failure with preserved ejection fraction (HFpEF).
-- Teprotumumab (IGF-1R) : the NDA for TED is under NMPA review. With
a longstanding lack of innovative TED treatments in China,
Teprotumumab is set to be a transformative therapy for this
significant unmet need once approved.
-- Picankibart (IL-23p19) : the only IL-23p19 that reported over 80%
subjects achieving >=90% improvement in Psoriasis and Severity
Index (PASI90) in 16 weeks of treatment, along with strong
long-term skin clearance maintenance and quarterly dosing interval
advantage. We plan to submit an NDA in the second half of 2024.
-- IBI128 (XOI) : potential best-in-class XOI for the treatment of
hyperuricemia in gout patients. It is currently undergoing
overseas Phase 3 clinical trials overseas with our partner LG Chem,
and we have completed patient enrollment for a Phase 2 clinical
trial in China.
-- IBI302 (VEGF/C) : Phase 3 study initiated for the treatment of
nAMD, following stable and robust visual benefit observed with
an extended dosing interval and potential macular atrophy
inhibition in two Phase 2 studies.
Abundant early-stage pipeline to support long-term growth and global ambition
-- Encouraging data readouts from multiple oncology assets in Phase 1
studies, eyeing most difficult-to-treat cancers
-- IBI363 (PD-1/IL-2<ALPHA>-bias) : preliminary positive signals in
multiple IO-failed/cold tumor types; further investigations across
different rumor types are ongoing; a Phase 2 clinical trial in the
U.S. has been initiated.
-- IBI343 (CLDN18.2 ADC) : encouraging positive signal in pancreatic
cancer, with FDA fast track designation granted. Plans are
underway for a clinical trial in the U.S.
-- IBI389 (CLDN18.2/CD3) : encouraging and differentiated signals in
GC and PDAC in Phase 1 studies; Phase 1b study is continuing.
-- Multiple programs ongoing including IBI3003 (GPRC5D/BCMA/CD3),
IBI115 (DLL3/CD3); IBI3004 (DR5/CEA); IBI3001 (EGFR/B7H3 ADC),
IBI130 (TROP2 ADC), IBI133 (HER3 ADC)
-- Develop next-generation general biomedicine programs to improve chronic
disease treatment
-- IBI3016 AGT siRNA : a new-generation siRNA drug candidate, entered
into a Phase 1 clinical trial for hypertension.
-- IBI355 (CD40L), IBI356 (OX40L) and IBI3002 (IL-4R<ALPHA>/TSLP)
: innovative autoimmune molecules entered into first-in-human
studies to explore other unmet medical needs in various types of
autoimmune diseases.
-- IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the
Phase 1 stage to explore the potential differentiation clinical
values versus existing therapy.
Research innovation published in high-impact scientific journals and medical conferences, such as:
-- AACR, ASCO, ESMO GI and ESMO plenary for oncology pipeline innovation,
including 10+ oral presentations
-- ADA, APAO, ICE, CSE for general biomedicine pipeline material progress,
such as mazdutide and teprotumumab
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August 28, 2024 06:37 ET (10:37 GMT)
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