On August 23, 2023 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, reported its interim results for the first half of 2023, along with a corporate update (Press release, Everest Medicines, AUG 23, 2023, View Source [SID1234634660]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are pleased to have achieved a number of critical milestones during the first half of 2023, propelling Everest to a commercial stage biopharma," commented Rogers Yongqing Luo, CEO of Everest Medicines. "At the end of July, we successfully took the critical step of launching our first therapeutic drug in China, Xerava, which is the world’s first fluocycline antibiotic for the treatment of multi-drug resistant infections. To support Xerava’s launch, we have built a lean and efficient commercial team of highly experienced professionals, which we will gradually scale up as we prepare for additional product debuts. Over the next 18-24 months, we expect to have three additional products approved in China."
"Being one of very few biotech companies with a substantial lineup of products prepared for launch over the next two years clearly demonstrates our expertise in selecting and commercializing promising drug candidates. We expect to receive NDA approvals from both China and Singapore in the second half of 2023 for Nefecon, our first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and launch Nefecon broadly in China in early 2024. We will also continue to broaden our product pipeline through our dual approach of in-licensing and internal discovery, targeting underserved conditions and areas of high unmet need with innovative and differentiated therapies. Through a series of measures to improve operational efficiency and restructure our strategic focus, we have significantly reduced expenses across different functions and narrowed net loss in the first six months of this year by more than a third compared to a year ago. This will allow Everest to continue to generate value for our stakeholders and shareholders," said Mr. Luo.
Recent Product Highlights and Anticipated Milestones
INFECTIOUS DISEASE PORTFOLIO
Eravacycline (Xerava), is the world’s first Fluorocycline antibiotic for the treatment of infections caused by gram negative, gram positive and anaerobic pathogens including multidrug-resistant ("MDR") isolates. Its current approved indication is cIAI in adult patients.
Achievements during the Reporting Period:
On March 16, 2023, the Company announced that China’s NMPA approved its NDA for Xerava in the treatment of cIAI in adult patients, marking it the first product to be commercialized by the Company in China.
Post-Reporting Period achievements and expected milestones:
On July 26, 2023, Xerava was successfully launched in China with its first prescriptions issued at Huashan Hospital affiliated to Fudan University. The commercialization of Xerava in China marks the Company’s transformation into a commercial-stage innovative biopharmaceutical company.
We expect NDA approval for eravacycline for the treatment of cIAI in the Taiwan region in 2023.
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").
Post-Reporting Period achievements and expected milestones:
On 15 August 2023, our partner Venatorx Pharmaceuticals announced that the US FDA has accepted the NDA for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections("cUTI"), including pyelonephritis. The FDA has granted priority review of the NDA with a Prescription Drug User Fee Act ("PDUFA") target action date of February 22, 2024.
EVER206 (also known as SPR206), is a potentially best-in-class, novel polymyxin derivative designed to reduce toxicity, especially nephrotoxicity, compared to levels observed clinically with polymyxin B and colistin.
Achievements during the Reporting Period:
On January 18, 2023, the Company announced topline results from a China phase 1 study on healthy subjects demonstrating that EVER206 is well-tolerated with no evidence of acute kidney injury and no new safety signals on healthy subjects with dose ranges applied in the study. The pharmacokinetics of healthy subjects in China were comparable to the results of the overseas phase I study (SPR206-101) and the safety profile was also similar to the results from the overseas Phase I trial, supporting the Company’s plans to initiate next-phase clinical development in China.
RENAL PORTFOLIO
Nefecon, our anchor drug candidate in the renal therapeutic area, is a patented oral, delayed release formulation of budesonide in development for the treatment of IgAN.
Achievements during the Reporting Period:
On February 10, 2023, South Korea’s Ministry of Food and Drug Safety ("MFDS") granted Global Innovative product on Fast Track ("GIFT") designation to Nefecon for the treatment of primary IgAN. South Korea’s GIFT program was launched in September 2022 to further accelerate review timeframes, especially for groundbreaking products. Nefecon is the second product overall and the first non-oncology product included in MFDS’s GIFT program. Inclusion in the GIFT program is expected to accelerate regulatory review time by 25% and allow for rolling review.
On March 12, 2023, our partner Calliditas Therapeutics AB ("Calliditas") reported positive topline results from a Phase 3 NefIgArd Trial evaluating Nefecon in the treatment of IgAN. The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value <0.0001) in estimated glomerular filtration rate ("eGFR") over a 2-year period, which included nine months of treatment period with either Nefecon or placebo, then followed by 15 months off drug, observational follow-up period. The primary endpoint, time-weighted average change from baseline in eGFR over the 2-year period, demonstrated a 5.05 mL/min/1.73 m2 eGFR treatment benefit in favor of Nefecon compared to placebo over two years was observed (p<0.0001). Time-weighted average change from baseline in eGFR over the 2-year period was -2.47 mL/min/1.73 m2 for Nefecon 16mg group versus -7.52 mL/min/1.73 m2 for placebo group.
On April 6, 2023, Singapore Health Sciences Authority accepted the NDA for Nefecon for the treatment of IgAN in adults at risk of disease progression. The Company expects to receive NDA approval in Singapore in 2023.
In June 2023, our partner Calliditas presented more complete data from the NefIgArd Phase 3 Study at the European Renal Association — European Dialysis and Transplant Association Congress (ERA-EDTA). Most noteworthy is that data showed at 24 months, eGFR was reduced by 6.11 mL/min/1.73 m2 from baseline in the Nefecon arm compared with 12 mL/min/1.73 m2 reduction in the placebo arm, demonstrating 50% less loss of kidney function. The reduction in urine protein creatinine ratio ("UPCR") was also durable, with a 30.7% decrease in UPCR in the Nefecon arm even after 15 months off drug compared with only 1% reduction in the placebo arm. Another analysis of the effect of durability of proteinuria reduction showed a 41% reduction in time-averaged UPCR over 12–24 months compared with placebo (95% CI 32-49%, p<0.0001). As for the hematuria treatment, the proportion of patients with microhematuria in the Nefecon arm fell to 40.5% from 66.5% baseline while the placebo arm only decreased to 61.2% from 67.8% baseline. This data was published in The Lancet in August 2023.
On June 21, 2023, our partner Calliditas announced the submission of a supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration("FDA") seeking full approval of TARPEYO (brand name of Nefecon in the US) delayed release capsules for the entire study population from the Phase 3 NefIgArd study. The sNDA submission is based on the full data set from the Phase 3 NefIgArd clinical trial. The trial met its primary endpoint, with TARPEYO demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in eGFR over the two-year period of 9 months of treatment with TARPEYO or placebo and 15 months of follow-up off drug. Calliditas announced FDA accepted the sNDA with priority review on Aug. 18.
Post-Reporting Period achievements and expected milestones:
On August 1, 2023, the Company announced the completion of patient enrollment for the China open-label extension ("cOLE") of the Phase 3 NefIgArd study. The cOLE study offers an additional 9 months of treatment with Nefecon to all qualifying patients who have completed the NefIgArd study and will evaluate the efficacy and safety of extended and repeated Nefecon treatment in patients with IgAN.
We expect to receive NDA approval for Nefecon in the treatment of primary IgAN in mainland China and Singapore in 2023.
We expect to file an NDA for Nefecon in the treatment of IgAN in South Korea, Hong Kong, Macau and Taiwan region in 2023.
AUTOIMMUNE DISEASE PORTFOLIO
Etrasimod, is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5. In addition to UC, it is being investigated for a range of other immuno-inflammatory diseases.
Achievements during the Reporting Period:
On May 17, 2023, the Company announced the completion of patient enrollment in a multi-region, multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of moderate-severe active ulcerative colitis ("UC").
Post-Reporting Period achievements and expected milestones:
Our licensing partner, Pfizer Inc. (NYSE: PFE) ("Pfizer") expects to receive FDA’s decision for etrasimod for individuals living with moderately-to-severely active UC in the second half of 2023. The NDA was accepted by the U.S FDA in December 2022.
We expect to readout 12-week induction of clinical remission data of etrasimod for the treatment of UC from the Asia Phase 3 clinical trial and discuss the potential regulatory filing strategy with relevant regulatory authorities in 2023.
mRNA PLATFORM
EVER-COVID19-M1.2, is an Omicron-targeting bivalent COVID-19 booster vaccine candidate.
Achievements during the Reporting Period:
Leveraging our clinically validated mRNA platform, the Company is developing an Omicron-containing bivalent booster candidate, EVER-COVID19-M1.2. The Company has initiated rolling data submissions for its Investigational New Drug (IND) application in China.
Commercialization
The Company is committed to making its new therapeutics available to healthcare providers and patients as soon as possible. We have dedicated significant resources for the successful launch of Xerava and facilitate our transition into a commercial-stage company. We have built a lean and efficient commercial team of highly experienced professionals covering two key therapeutic areas, infectious disease and renal diseases. As of June 30, 2023, our commercial team has 138 members, including key employees across sales, marketing, market access, medical affairs, distribution and commercial excellence.
The Company also established multiple partnerships with China’s leading pharmaceutical distributors, including SPH Keyuan Xinhai Pharmaceutical Co., Ltd., Sinopharm Group, Guangzhou Pharmaceuticals Co., Ltd., Chongqing Pharmaceutical Group and Shanghai Pharmaceutical Co., Ltd. Under these partnerships, we will be able to leverage their industry-leading import and channel distribution networks to accelerate the commercialization of Xerava in China.
Nefecon is expected to be the second product the Company commercializes in China. In April 2023, we introduced Nefecon in China’s Hainan Boao Pilot Zone to provide Chinese patients with IgAN early access to this innovative and first-in-disease therapy. Our early access program was well-received with over 500 patients signed up, highlighting the substantial unmet clinical needs of IgAN patients in China. Given the high prevalence of IgAN in China, our team is working diligently to have Nefecon included in insurance programs to boost its affordability and accessibility, helping to alleviate patients’ financial burden. As a result, in May 2023, the imported version of Nefecon was added to the Beijing Puhui Health Insurance Program’s 2023 New Reimbursement Drug List of Specialized Medicines, as well as other local insurance programs such as Kunming City and Shanxi Province. We expect to receive the NDA decision from China’s NMPA in the second half of 2023 and launch Nefecon broadly in China in early 2024.
Discovery
Our discovery pipeline focuses on novel targets for the treatment of renal diseases, and we expect to file an IND to enter clinical trials for our most advanced program in 2024. Additionally, with our clinically validated mRNA platform, we are advancing the discovovery and development of prophylactic vaccines for infectious diseases as well as therapeutic cancer vaccines for solid tumors.
Business Development
Our business development efforts focus on renal diseases and autoimmune disorders. We look to continue to bolster our leadership position in these areas by expanding our pipeline and ecosystem through a combination of internal discovery and in-licensing. We are actively engaged in finding business partnerships in these disease areas.
As we previously reported, in August 2022 Immunomedics, Inc. ("Immunomedics"), a wholly-owned subsidiary of Gilead Sciences, Inc., agreed to acquire the Company’s rights to Trodelvy for total consideration of up to US$455 million, including US$280 million in upfront payments. The Company received the full upfront payments in late 2022 and in the first quarter of 2023, strengthening our balance sheet and empowering us to advance the development of products in our core therapeutic areas.
Future Development
We will continue to pursue regulatory approvals for our innovative drug candidates, applying our effective dual approach of in-licensing and internal discovery to expand our existing robust pipeline. In the near-term, we expect to receive NDA approvals in China for three additional products, Nefecon, etrasimod, and cefepime-taniborbactam. Notably, we are one of very few biotech companies expected to launch a broad lineup of products in the near term.
Given the anticipated NDA approvals mentioned above, we have assembled a talented commercial team for the launch of Xerava and Nefecon. We will expand the team later this year as Nefecon’s debut approaches, as well as in 2024 to establish deeper and broader hospital coverage.
Financial Highlights
IFRS Numbers:
Revenue increased by RMB7.9 million to RMB8.9 million for the six months ended 30 June 2023 from the same period of a year ago, primarily due to the sales of Xerava and Trodelvy during transition period with Gilead in Singapore.
Research and development ("R&D") expenses decreased by RMB57.0 million from RMB345.5 million for the six months ended 30 June 2022 to RMB288.5 million for the six months ended 30 June 2023, primarily due to (i) a number of our drug candidates have completed clinical trials and advanced to regulatory submission or commercial stages; and (ii) the transfer of Trodelvy clinical development activities to Gilead.
General and administrative expenses decreased by RMB35.8 million from RMB118.9 million for the six months ended 30 June 2022 to RMB83.1 million for the six months ended 30 June 2023, mainly due to organization optimization and rationalization, and associated decrease in share-based compensation expenses.
Distribution and selling expenses decreased by RMB84.1 million from RMB148.2 million for the six months ended 30 June 2022 to RMB64.1 million for the six months ended 30 June 2023, primarily due to the transfer of Trodelvy-related commercial activities to Gilead and related optimization and rationalization of the organizational structure since August 2022.
Net loss for the period decreased by RMB244.4 million from RMB668.0 million for the six months ended 30 June 2022 to RMB423.6 million for the six months ended 30 June 2023, primarily attributable to (i) a number of our drug candidates have completed clinical trials and advanced to the registration phase or commercial stages; (ii) the transfer of Trodelvy related clinical and commercial activities to Gilead; and (iii) optimization and rationalization of the organizational structure.
Cash and cash equivalents and bank deposits amounted to RMB2,540.2 million as of 30 June 2023.
NON-IFRS MEASURE:
Adjusted loss for the period decreased by RMB196.8 million from RMB523.7 million for the six months ended 30 June 2022 to RMB326.9 million for the six months ended 30 June 2023, primarily attributable to narrowed IFRS loss.
Conference Call Information
The English session of the conference call will be held at 9:00 AM on August 24, 2023 Beijing Time (9:00 PM U.S. Eastern Time on August 23, 2023) and the Mandarin session of the conference call will be held at 3:30 PM Beijing Time on the same day (3:30 AM U.S. Eastern Time on August 24, 2023).
The conference calls can be accessed by the following links:
For English Session:
Time: 9:00 AM Beijing Time, Thursday, August 24, 2023
Pre-Registration Link: View Source
Webcast Link: View Source