SHANGHAI, Aug. 27, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today announced its interim results for the first half of 2024 along with a corporate update.
“Our total revenue for the first half of 2024 reached RMB 301.5 million, a significant growth of 158% compared to the second half of 2023, while operating expenses as a percentage of revenue[1] declined by 249%, reflecting significant improvement on operating efficiency,” commented Rogers Yongqing Luo, CEO of Everest Medicines. “Notably, our non-IFRS loss narrowed by 35%, and our gross margin excluding non-cash items was 83%. For the first time in Company history, we have achieved commercial level profitability[2]. Our cash balance of RMB1.93 billion remains strong and provides significant flexibility to fund the continued growth of our business. In the first half of 2024, we accomplished multiple commercialization milestones. NEFECON®, our lead product in the renal portfolio and the first-in-disease treatment for adults with primary IgAN, was commercially launched in mainland China and Singapore, and approved in Hong Kong. XERAVA®, our first commercialized product in China and a first-in-class fluorocycline antibiotic, continues to show robust sales growth. In the autoimmune disease space, our lead product etrasimod was approved in Macau.”
“We will continue to drive revenue growth through our dual-engine strategy. First, we seek to license in products that can leverage the current commercial platform to maximize synergies, and continuously boost revenue, operational efficiency and profits through our efficient and focused commercialization model. We believe this will lead to stable and healthy revenue growth. Second, we look to unlock partnering and value creation opportunities with our mRNA discovery pipeline and our products with global rights . We recently announced the launch of the first-in-human Investigator-Initiated Clinical Trial (IIT) for EVM16, a personalized mRNA cancer vaccine program. We also anticipate submitting investigational new drug applications in the United States and China in 2025 for EVM14, a Tumor-Associated Antigens (TAA) cancer vaccine program. In the second half of 2024, we intend to continue to expand our market presence, revenue base and operational efficiency, by continuing to carry out our efficient and focused commercialization model, with “improvement, integration, and transformation” as our motto. We will continue to grow NEFECON® sales and actively engage in China’s National Reimbursement Drug List (NRDL) negotiations to enhance affordability and accessibility. By deepening penetration at our core hospitals and ramping up CSO collaborations, we aim to boost XERAVA® sales. Finally, we expect to launch etrasimod in Macau and access patients in China through preferential policies in the Greater Bay Area, and therefore we expect to have three commercialized products by the end of 2024. We maintain our revenue guidance of RMB 700 million for this year and remain confident in achieving our goal of cash flow breakeven by the end of 2025,” Mr. Luo concluded.
Recent Key Product Highlights and Anticipated Milestones
RENAL PRODUCTS PORTFOLIO
NEFECON®
– In March 2024, Singapore Health Sciences Authority approved NEFEGAN® for the treatment of primary IgAN in adults at risk of disease progression. NEFEGAN®, known in other Everest’s territories as NEFECON®, was the first ever treatment for IgAN fully approved by the U.S. Food and Drug Administration, and Singapore marks the third region in Everest’s territories that received New Drug Application (“NDA”) approval after Macau and mainland China. The product has been launched in Singapore following its approval.
– In March 2024, our partner Calliditas Therapeutics AB (“Calliditas”) announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO® (the U.S. trade name for NEFECON®), expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product.
– In April 2024, our partner Calliditas announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating NEFECON® in patients with IgAN were presented at the ISN World Congress of Nephrology. The data showed the treatment effect of NEFECON® on the risk of kidney function decline was consistent regardless of baseline UPCR and there were no meaningful differences in any quality of life (“QoL”) domains between NEFECON® and placebo groups after 9 months of treatment.
– In April 2024, our partner Calliditas announced positive results of the global Open Label Extension (“OLE”) study to the Phase 3 NefIgArd study. The OLE study was designed to provide 9 months of treatment with NEFECON® for all patients who completed the NefIgArd study and who at that time had > 1g/g of proteinuria over 24h and>30 ml/min of estimated glomerular filtration rate (“eGFR”). Topline data from the OLE study showed that the treatment response was consistent with the NefIgArd study’s findings regarding the endpoints of UPCR and eGFR at 9 months across all patients, irrespective of whether they had previously been treated with NEFECON® or with placebo. The safety data after 9 months of treatment or retreatment with NEFECON® in patients who completed the NefIgArd study were consistent with previously reported safety data.
– In April 2024, the Hong Kong Department of Health approved NEFECON® for the treatment of primary IgAN in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories that NEFECON® received NDA approval after Singapore, Macau and mainland China.
– In May 2024, NEFECON® was successfully launched in mainland China. The official launch of NEFECON® marks the inception of better patient care in mainland China, heralding a new era in the treatment of IgAN. The first prescription of NEFECON® was issued through an internet hospital, enhancing speed and convenience of delivering medication to patients and improving their accessibility. As part of the pre-launch preparation, Everest had initiated an early access program in the Hainan Boao pilot zone in 2023. Approximately 700 patients registered for this program. Following the NDA approval of NEFECON® in Macau in December 2023, a few hundred patients from mainland China received prescription of the medication in Macau. In addition, over 23,000 Chinese patients have registered in an IgAN patient program. These initiatives highlight the urgent and unmet medical needs for NEFECON® in IgAN patients, and provide a foundation for the rapid adoption in mainland China.
– In May 2024, our partner Calliditas disclosed Asahi Kasei Corporation’s (“Asahi Kasei”) public cash offer to acquire all shares in Calliditas for SEK 208 in cash per Share (the “Offer”). The Offer will also include a concurrent offer by Asahi Kasei to acquire all American Depositary Shares (“ADS”), each representing two Shares in Calliditas, for SEK 416 in cash per ADS, which will be conducted pursuant to the securities rules of the United States. The total value of the Offer corresponds to SEK 11,164 million.
– In June 2024, our partner Calliditas announced an analysis of the treatment benefits of of NEFECON® compared with sparsentan in IgAN at the 61st European Renal Association Congress (ERA 2024). The presented analysis showed that treatment with NEFECON® 16 mg/day for 9 months was associated with eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years.
Post-Reporting Period achievements and expected milestones:
– In July 2024, China’s National Medical Products Administration accepted the submission of a supplemental New Drug Application (sNDA) seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study. NEFECON® is expected to become the first-in-disease IgA nephropathy (IgAN) treatment to receive full approval by the NMPA.
– In July 2024, our partner Calliditas announced that the European Commission has granted a full marketing authorization for Kinpeygo (the European trade name for NEFECON®) for the treatment of adults with primary IgAN.
– We expect to report topline results from our open label study of NEFECON® in China in the second half of 2024.
– We expect to receive NEFECON® NDA approval in South Korea in the second half of 2024.
– We expect to commercially launch NEFECON® in Hong Kong in the second half of 2024.
– We expect inclusion of NEFECON® in the Kidney Disease: Improving Global Outcomes (“KDIGO”) 2024 guidelines as well as in the first Chinese guideline for IgAN in the second half of 2024.
Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for a range of immune-mediated disorders, including lupus nephritis (“LN”). It was licensed from Kezar Life Sciences (“Kezar”) in September 2023 for development and commercialization in Greater China, South Korea and Southeast Asia.
– In February 2024, the Center for Drug Evaluation (CDE) of NMPA approved Kezar’s IND application of zetomipzomib for initiation of the Phase 2b PALIZADE trial in China in patients with active LN. LN is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney failure. There are an estimated 400,000-600,000 LN patients in China.
– In July 2024, the first Chinese patient has been dosed in the global Phase 2b PALIZADE trial for the treatment of active LN. Leveraging the company’s strengths in clinical development, regulatory filing, and commercialization, we will accelerate the development of zetomipzomib to benefit patients in China as soon as possible.
EVER001 (previously known as XNW1011), is the next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases.
– We expect to report topline results from EVER001 Phase 1b study in membranous nephropathy in the second half of 2024.
INFECTIOUS DISEASE PORTFOLIO
XERAVA® (eravacycline)
– In January 2024, eravacycline’s clinical breakpoint was officially approved by Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (ChinaCAST), so that the drug can be used more accurately in clinical practice in China.
– In August 2024, the Expert Committee on Clinical Application and Resistance Evaluation of Antimicrobial Drugs of the National Health Commission published positive interim results from the “Comprehensive Evaluation Project on the Clinical Application of Eravacycline”. The results showed that the overall efficacy rate of eravacycline was 89.0% at the end of treatment, and incidence of adverse effect was only 2.9%.
Taniborbactam is a beta-lactamase inhibitor (“BLI”) that, in combination with cefepime, may offer a potential treatment option for patients with serious bacterial infections caused by difficult-to-treat resistant gram-negative bacteria, most notably carbapenem- resistant Enterobacterales (“CRE”) and carbapenem-resistant Pseudomonas aeruginosa (“CRPA”).
– In February 2024, our partner Venatorx Pharmaceuticals announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (“cUTI”), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of cUTI that included acute pyelonephritis, with a similar safety profile to meropenem.
– We expect to submit NDA of cefepime-taniborbactam for the cUTI indication in mainland Chinain 2025.
AUTOIMMUNE DISEASE PORTFOLIO
VELSIPITY® (etrasimod)
– In Feb. 2024, partner Pfizer Inc. announced that the European Commission has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
– In March 2024, Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, accepted Everest’s NDA for VELSIPITY® (etrasimod) for the treatment of moderately to severely active ulcerative colitis.
– In April2024, Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China approved the NDA for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active UC. It marks the first approval of VELSIPITY® in Everest territories. The number of UC patients in China is projected to double from 2019 to 2030 to approximately one million by 2030, highlighting the urgent need for novel treatments. Leveraging the preferential policies in the Greater Bay Area in China, we’re poised to accelerate drug accessibility for mainland China following the Macau approval.
– In May 2024, Singapore Health Sciences Authority approved VELSIPITY™ (etrasimod) for adults with moderately to severely active ulcerative colitis (UC).
Post-Reporting Period achievements and expected milestones:
– In July 2024, Everest announced positive topline data results of the maintenance period from a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of subjects with moderately-to-severely active UC. This is the largest Phase 3 trial of moderately-to-severely active UC in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The data of maintenance period confirmed that, after 40 weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p