On August 28, 2024 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, reported its 2024 interim results and major business updates (Press release, Innovent Biologics, AUG 28, 2024, View Source [SID1234646172]).
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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, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE, Olverembatinib, CYRAMZA, Retsevmo, FUCASO , SINTBILO and DUPERT (new product, KRAS G12C inhibitor) .
TYVYT and PEMAZYRE were newly approved in the Macau market.
TYVYT and BYVASDA 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 (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 (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 (sintilimab): submitted an NDA for its eighth indication, 2L endometrial cancer (EMC). 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-2α-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-4Rα/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 (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) GI and ESMO (Free ESMO Whitepaper) plenary for oncology pipeline innovation, including 10+ oral presentations
ADA, APAO, ICE, CSE for general biomedicine pipeline material progress, such as mazdutide and teprotumumab
Facilitates and Manufacturing capacity adhering to high-standard quality:
Shanghai R&D center (medical) is newly operational in August 2024
First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation
Second manufacturing site: first phase of 80,000L completed construction to secure CDMO business
Devoted to responsible business practices and enhancing ESG management practices
We remain committed to sustainable development, corporate responsibility and
ethical business practices. We newly launched our ESG website to enhance our efforts in sustainability, corporate responsibility and ethical business conduct. The new platform highlights our initiatives, policies and performance in key ESG areas, including "Excellent Governance", "Enjoying Good Health", "Ensuring High-Quality Products", "Empowering Employees", and "Embracing Ecology".
Innovent is graded ‘A’ level in MSCI ESG rating, ranking at the forefront of the biotechnology industry.