Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced its financial results for full year ended December 31, 2020, along with corporate progress.
"Despite the macro challenges and volatility experienced around the world throughout 2020, Everest Medicines continues to position itself for tremendous long-term growth, including the significant momentum we have gained across our promising pipeline of innovative drug candidates," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We have continued to progress a number of our lead therapeutic candidates, initiating late-stage clinical trials for sacituzumab govitecan-hziy in two difference breast cancer indications with high unmet medical need, completing a Phase 3 bridging trial, and this month, had our New Drug Application (NDA) of eravacycline accepted by the China National Medical Products Administration (NMPA) for the treatment of complicated intra-abdominal infections (cIAI). We have also obtained Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgA nephropathy (IgAN) in China."
"Looking forward, we expect 2021 to be another fruitful year for Everest Medicines," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We will continue to focus on executional excellence across our clinical development programs as we also prepare the Company to become a commercial organization and build on our plans to expand our international business, manufacturing and discovery efforts. We are confident Everest Medicines is well positioned to deliver value for our patients and stakeholders."
Business Review
The Company was successfully listed on The Stock Exchange of Hong Kong, S.A.R., China Limited (the "Stock Exchange") on 9 October 2020 (the "Listing Date"). Since then, the Company has made significant progress advancing its product pipeline and enhancing its business operations.
Sacituzumab govitecan-hziy (TrodelvyTM), our anchor drug candidate in oncology therapeutic area, is a first-in-class TROP-2 directed antibody-drug conjugate (ADC).
- On 2 November 2020, the China NMPA approved a Clinical Trial Application (CTA) for sacituzumab govitecan- hziy for a regional Phase 3 registration clinical trial, EVER-132-002, designed to assess and compare the efficacy and safety of sacituzumab govitecan-hziy versus Treatment of Physician's Choice (TPC) in Asian patients with hormone receptor positive, HER2 negative metastatic breast cancer (HR+/HER2- mBC) who received at least two, and no more than four, systemic chemotherapy regimens. The trial will enroll approximately 330 HR+/HER2- mBC patients in Mainland China, Taiwan, China Region of China and South Korea. On 9 December 2020, the first patient was dosed in this Phase 3 study.
- On 3 November 2020, the first patient was dosed in China into our EVER-132-001 Phase 2b registration clinical trial evaluating sacituzumab govitecan-hziy for the treatment of patients with metastatic triple negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. EVER-132-001 will enroll approximately 80 mTNBC patients in China. It is worth mentioning that sacituzumab govitecan-hziy has also been included in the newly updated 2020 Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.
- On 6 January 2021, we submitted a NDA to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease.
- On 6 January 2021, the China Center for Drug Evaluation (CDE) of the China NMPA approved a CTA for sacituzumab govitecan-hziy for the treatment of patients with mUC. With this CTA, we plan to enroll patients in China as part of the Phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial. The trial will evaluate sacituzumab govitecan-hziy compared with standard of care chemotherapeutic options in subjects with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) therapy. Subjects will be randomized to receive either sacituzumab govitecan-hziy or TPC, including paclitaxel, docetaxel, and vinflunine.
- In the second half of 2021, we expect to read-out topline results of the China EVER-132- 001 Phase 2b registration clinical trial for mTNBC and initiate patient enrollment in China as part of the global Phase 3 TROPiCS-04 clinical trial for metastatic urothelial cancer (mUC).
- Our partner Gilead Sciences, Inc. (Gilead) anticipates obtaining full U.S. Food and Drug Administration (US FDA) approval for mTNBC and accelerated US FDA approval for mUC in the first half of 2021, as well as releasing topline results from the global Phase 3 TROPiCS-02 study HR+/HER2- mBC in the second half of 2021. Phase 1 TROPiCS-03 basket study continues to progress, Gilead expects to provide an update, particularly in non-small cell lung cancer, in the second half of 2021.
Nefecon, our anchor drug candidate in cardio-renal therapeutic area, is a novel oral formulation of budesonide in the development for the treatment of IgAN.
- On 10 November 2020, our licensing partner, Calliditas, reported positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which analyzed the effect of Nefecon versus placebo in 199 patients with primary IgAN. The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment compared to placebo. The efficacy data indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease for IgAN patients. In addition, results showed that Nefecon was generally well-tolerated.
- On 2 December 2020, the China CDE of the NMPA recommended and subsequently granted BTD for Nefecon for the treatment of IgAN. We are currently enrolling patients as part of the Phase 3 global registrational study NefIgArd to support approval for IgAN patients in China.
- We expect to complete patient enrollment in China into the NeflgArd Phase 3 global registration study for IgAN in the first half of 2021.
Eravacycline (XeravaTM), is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as first-line empiric monotherapy for the treatment of multidrug resistance (MDR) infections, including MDR Gram-negative infections.
- On 27 October 2020, we completed a Phase 3 bridging clinical trial of eravacycline which enrolled a total of 144 treated patient, for the treatment of cIAI in China.
- China NMPA accepted a NDA for eravacycline for the treatment in cIAI in China in March 2021 as our first NDA submission in China.
Other assets
- We expect to announce topline results in the Phase 3 global clinical trial for Taniborbactam for complicated urinary tract infections (cUTI) in 2021.
- We plan to initiate Phase 2 clinical trial for FGF401 for the treatment of hepatocellular carcinoma in China in the second half of 2021.
Corporate Development
- In January 2021, we entered into an amended license agreement with Spero Therapeutics under which the relevant patents for SPR206 will be assigned to us in Greater China, South Korea and certain Southeast Asian countries. SPR206 is in clinical development as an innovative option for the treatment of MDR Gram-negative bacterial infections.
- On 18 February 2021, we appointed Kevin Guo as our Chief Commercial Officer. Mr. Guo has more than 22 years of commercial leadership and business management experience across a number of multinational pharmaceutical companies.
- We have been selected as a constituent stock of the Hang Seng Composite Index, the Hang Seng Healthcare Index and the Hang Seng Hong Kong, S.A.R., China-Listed Biotech Index in accordance with the latest index series release by Hang Seng Indexed Company Limited, with effect from 15 March 2021. Being selected as a constituent stock of the above Hang Seng Indexes fulfills the eligibility criteria for Southbound Trading under the Stock Connect Scheme, which is a channel that facilitates stock trading and investment between Hong Kong, S.A.R., China and a broader base of China investors.
Future Development
We will continue to build a leading biopharmaceutical company focused on the development and commercialization of globally innovative therapies, initially in Greater China and other Asia Pacific markets. To achieve the goal, we will strive to advance our existing drug candidates into and through registrational trials and will seek the most efficient approval pathways. In the meantime, we will continue to expand our innovative drug portfolio in areas of high unmet medical needs across our chosen therapeutic areas through in-licensing and building organic discovery capabilities. To support our anticipated commercial launch of multiple late-stage products, we have commenced building a commercial team with deep knowledge of sales, marketing and market access strategies across a range of therapeutical areas. In addition, we are building our own GMP/GSP manufacturing facilities in China in order to ensure stable and sufficient long term drug supply and to optimize the cost of goods.
Financial Highlights
IFRS Numbers:
Research and development expenses increased by RMB226.5 million to RMB377.4 million for the year ended 31 December 2020, from RMB150.9 million for the year ended 31 December 2019, primarily due to additional clinical trials of our drug candidates and the expansion of our research and development headcount.
General and administrative expenses increased by RMB223.9 million to RMB277.8 million for the year ended 31 December 2020, from RMB53.9 million for the year ended 31 December 2019, primarily due to initial public offering ("IPO") costs and the increase in employee remuneration in connection with organization expansion.
The loss from fair value change in financial instruments issued to investors increased by RMB4,901.5 million to RMB4,938.0 million for the year ended 31 December 2020, from RMB36.5 million for the year ended 31 December 2019, primarily attribute to significant increase in the per share fair value upon the completion of the IPO of the Company when re-measuring convertible redeemable preferred shares previously issued to the investors before conversion into the Company's ordinary shares.
Net loss for the year ended 31 December 2020 increased to RMB5,658.2 million, from RMB214.5 million for the year ended 31 December 2019, primarily due to the loss of RMB4,938.0 million in fair value change in financial instruments issued to investors, which was a non-cash and one-time adjustment upon the listing as required under the International Financial Reporting Standard ("IFRS").
Non-IFRS Measure:
Adjusted loss for the year[1] was RMB602.9 million for the year ended 31 December 2020, representing an increase of RMB439.8 million from RMB163.1 million for the year ended 31 December 2019, primarily due to the increase in research and development expenses and general and administrative expenses.
[1] Adjusted loss for the year represents the loss for the year attributable to the equity holders of the Company excluding the effect of certain non-cash items and one-time events, namely the loss on fair value changes of preferred shares (non-current financial liabilities measure at fair value through profit or loss) and share-based compensation loss.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.
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