On March 28, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported its financial results for full year ended December 31, 2021, along with a corporate progress update (Press release, Everest Medicines, MAR 28, 2022, View Source [SID1234611070]).
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"Despite a challenging backdrop for the biopharmaceutical industry in 2021, we propelled the Company forward by achieving an impressive number of accomplishments across our business, including fostering key strategic partnerships, expanding its global presence by building teams in South Korea, Singapore, and the Taiwan region, receiving the first of several expected drug approvals for Trodelvy in Singapore and investing in COVID-19 vaccines and therapeutic candidates to address the world’s ongoing public health crisis," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines.
"As 2022 progresses, we look forward to building on the momentum established last year to position our company for sustained future growth. We will persist in growing our clinical capabilities, pursuing our global expansion strategy and building a commercial-ready biopharmaceutical company in order to provide innovative medicines to patients in need. We will strive to accomplish these goals, committed as always to the highest standards of quality and integrity," said Blanchard.
Recent Product Highlights and Anticipated Milestones
Sacituzumab govitecan-hziy (Trodelvy), our anchor drug candidate in the oncology therapeutic area, is a first-in-class TROP-2 directed antibody-drug conjugate (ADC).
Clinical and regulatory development achievements during the Reporting Period:
– In January 2021, we submitted a New Drug Application ("NDA") to the Health Sciences Authority ("HSA") of Singapore for sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease, and the indication was subsequently amended to second-line and later lines metastatic TNBC.
– In January 2021, the Center of Drug Evaluation ("CDE") of the China National Medical Products Administration ("NMPA") approved a China clinical trial application ("CTA") for sacituzumab govitecan for the treatment of patients with metastatic urothelial cancer ("mUC").
– In March 2021, the CDE of the China NMPA approved a CTA for a phase 2 basket trial for a variety of cancers with high TROP-2 expression. The trial is designed to evaluate sacituzumab govitecan monotherapy in 180 patients with relapse/refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer at select sites in China.
– In April 2021, the Company’s partner, Gilead Sciences, Inc. (Gilead), received full approval from the US FDA for Trodelvy for the treatment of adult patients with second-line metastatic triple-negative breast cancer (mTNBC).
– In April 2021, Gilead received accelerated approval from the US FDA for Trodelvy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.
– In May 2021, NMPA accepted the Biologics License Application ("BLA") for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC in adult patients. Following the BLA acceptance, sacituzumab govitecan was granted priority review by the CDE of China NMPA in May 2021.
– In May 2021, the Ministry of Food and Drug Safety ("MFDS") of South Korea had granted Fast Track Designation and Orphan Drug Designation to sacituzumab govitecan for the treatment of later line metastatic TNBC.
– In July 2021, Taiwan Food and Drug Administration ("TDFA") granted Pediatric and Rare Severe Disease Priority Review Designation for adult patients with second-line metastatic TNBC.
– In November 2021, the Company announced the topline results of its bridging study, EVER-132-001, a single-arm, multi-center Phase 2b study of sacituzumab govitecan conducted in China on patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one for metastatic disease.
– In December 2021, MFDS of South Korea accepted the Company’s NDA for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC in adult patients.
– In December 2021, TFDA accepted the NDA submission of sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC in adult patients.
– The phase 3 Asia study was ongoing, which is designed to assess and compare the efficacy and safety of sacituzumab govitecan versus treatment of physician’s choice in Asian patients with hormone receptor positive, HER2 negative metastatic breast cancer ("HR+/HER2- mBC") who have failed at least two prior chemotherapy regimens. The trial will enroll approximately 330 HR+/HER2- mBC patients in Greater China and South Korea. The enrollment of this study is expected to complete enrollment by the first half of 2022.
Post-Reporting Period milestones and expected achievements:
– In January 2022, the Company announced it will participate in a study pursuant to a clinical trial collaboration between Gilead and Merck & Co., Inc. (MSD) to evaluate the combination of sacituzumab govitecan and MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) in first-line metastatic non-small cell lung cancer (NSCLC).
– In January 2022, the HSA of Singapore approved the Company’s NDA for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC.
– In March 2022, our partner Gilead announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- mBC who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint with a statistically significant improvement in progression-free survival versus physician’s choice of chemotherapy.
– We anticipate receiving the BLA decision from China NMPA and NDA decision from the TDFA for sacituzumab govitecan for the treatment of second-line metastatic TNBC in 2022.
Nefecon (TARPEYO), our anchor drug candidate in cardio-renal therapeutic area, is a novel oral formulation of budesonide (budesonide delayed release capsules) in the development for the treatment of primary immunoglobulin A nephropathy ("IgAN").
Clinical and regulatory development achievements during the Reporting Period:
– The Company completed the Chinese patient enrollment into the NefIgArd Phase 3 global registrational study evaluating NEFECON as a treatment for primary IgAN.
– Our partner Calliditas Therapeutics AB, ("Calliditas") in April, 2021 granted an accelerated assessment procedure on its marketing authorization application ("MAA") for Nefecon in IgAN and submitted the MAA in May of 2021. In September 2021, Calliditas announced that the European Medicine Agency’s ("EMA") Committee for Human Medicinal Products ("CHMP") has decided to continue the assessment of the MAA for Nefecon under standard procedure assessment timelines, with potential conditional approval in second quarter of 2022.
– In December 2021, our partner Calliditas, announced that the US FDA approved TARPEYO (developed under Project name NEFECON) delayed release capsules the first and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.
Post-Reporting Period milestones and expected achievements:
– In March 2022, the Company entered into a license agreement with Calliditas to develop and commercialize NEFECON for the treatment of primary IgAN in South Korea, expanding its license in addition to rights held in Greater China and Singapore.
– We expect to conduct an interim analysis of the Chinese patients in the global phase 3 NefIgArd study and this is expected to lead to a regulatory submission in China in second half of 2022.
PTX-COVID19-B, a potentially best-in-class lipid nanoparticle-formulated mRNA COVID-19 vaccine with a strong immunogenicity and tolerability profile.
Clinical and regulatory development achievements during the Reporting Period:
– In December 2021, we announced jointly with Providence Therapeutics ("Providence") that scientists from both companies had analyzed the sequence of the SARS-CoV-2 Omicron variant, selected viral sequences and designed plasmid clones to develop a new version of the COVID-19 vaccine specifically targeting the new Omicron variant.
– In December 2021, PTX-COVID19-B was selected to be part of a World Health Organization (WHO) Solidarity Trial Vaccines (STV) clinical trial, an international, randomized clinical trial designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines.
Post-Reporting Period milestones and expected achievements:
– Providence will readout the data for the phase 2 trial of PTX-COVID19-B around mid-2022 and initiate a phase 3 trial for booster indication in mid-2022 as well.
Eravacycline (Xerava), is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as first-line empiric monotherapy for the treatment of multidrug resistant (MDR) infections, including MDR Gram-negative infections.
Clinical and regulatory development achievements during the Reporting Period:
– In March 2021 and September 2021 respectively, the China NMPA and the Department of Health of Hong Kong accepted an NDA for eravacycline for the treatment of complicated intra-abdominal infections (cIAI).
– In August 2021, the CDE of the China NMPA approved the CTA for eravacycline for the treatment of community-acquired bacterial pneumonia (CABP).
Post-Reporting Period milestones and expected achievements:
– We expect NDA approval for eravacycline for the treatment in cIAI in China within 2022.
Other clinical-stage assets
Clinical and regulatory development achievements during the Reporting Period:
– In August 2021, the Phase 1b/2 study evaluating FGF401 in combination with PD-1 inhibitor, pembrolizumab, in patients with advanced solid tumors, such as hepatocellular carcinoma (HCC) reached recommended Phase 2 dose. The trial is ongoing.
– In September 2021, we received the approval from the CDE of the China NMPA for the Investigational New Drug application under the Class One category for SPR206 (also known as EVER206), a novel, intravenous next-generation polymyxin product candidate in development for the treatment of MDR Gram-negative bacterial infections.
– Ralinepag is a potentially best-in-class oral, selective potent, once-daily IP receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). We continue to progress our Phase 3 registrational trial for PAH in China as part of a global Phase 3 study conducted together with our partner United Therapeutics.
Post-Reporting Period milestones and expected achievements:
– In March 2022, our licensing partner, Venatorx Pharmaceuticals, reported positive results from its pivotal Phase 3 study, CERTAIN-1, evaluating cefepime-taniborbactam, an investigational new drug, versus meropenem as a potential treatment for hospitalized adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.
– In March, our partner, Pfizer Inc. announced positive topline results from a phase 3 study of etrasimod in development for the treatment of moderately to severly active ulcerative colitis ("UC") patients. These data along with results from ELEVATE 52 are expected to form the basis for planned future regulatory filings. Results from the ELEVATE 52 study will be available by the end of first quarter.
– We are conducting a Phase 3 study for etrasimod for the treatment of moderately to severely active UC, which is expected to complete enrollment in 2023.
– We anticipate initiating the Phase 1b/2 trial of the EVER-001 (also known as XNW1011), a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of renal diseases in 2022.
– We expect Phase 1 clinical trials of EDDC-2214, as oral antiviral treatment against SAR-CoV-2 and its variants, to commence by the end of 2022.
Key Corporate Developments
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. Under Mr. Guo’s leadership, we continue to remain focused on advancing our work across four strategic pillars to launch strategy formulation, develop commercial capabilities, embrace and deploy innovative solutions, and expand our international footprint.
Effective 15 March 2021, the Company was selected as a constituent stock of the Hang Seng Composite Index, the Hang Seng Healthcare Index and the Hang Seng Hong Kong-Listed Biotech Index in accordance with the latest index series release by Hang Seng Indexed Company Limited. At the same time, the Company became eligible for Southbound Trading under the Stock Connect Scheme, which is a channel that facilitates stock trading and investment between Hong Kong and a broader base of Chinese investors.
On 15 April 2021, we appointed Dr. Jennifer Yang as our chief scientific officer, whose deep expertise in drug discovery and translational medicine will help the Company establish a robust discovery organization that contributes to the strategic expansion of our clinical development pipeline.
Effective 18 June 2021, the Company’s stock was included as a constituent stock of the Small Cap Index, FTSE All-Cap Index and FTSE Total-Cap Index in the FTSE Global Equity Index Series.
Effective 30 November 2021, the Company’s stock was added to the MSCI Global Small Cap Indexes — MSCI China Index.
Business Development Updates
In July 2021, the Company established key strategic partnerships with Tencent Holdings Limited (Tencent), Medbanks Health Technology Co., Ltd (Medbanks) and MediTrust Health Co., Ltd. (MediTrust) to explore innovative tools in digital marketing, patients’ access to novel medicines and payment solutions. In January 2022, the Company announced a strategic commercialization cooperation with Yuanxin Group and a strategic cooperation with the Sinopharm Group ("Sinopharm").
In September 2021, the Company entered into two separate definitive agreements with Providence, a clinical stage biotechnology company developing mRNA therapeutics and vaccines, to (i) license rights to Providence’s mRNA COVID-19 vaccine candidates in Asia’s emerging markets, including Greater China, Southeast Asia and Pakistan, and (ii) establish a broad, strategic partnership to develop mRNA products globally leveraging Providence’s cutting-edge mRNA technology platform.
In September 2021, we entered into an exclusive licensing agreement with Sinovent and SinoMab to develop, produce and commercialize EVER-001 (also known as XNW1011), a covalent reversible BTK inhibitor, globally for the treatment of renal diseases.
In September 2021, we announced a multi-year collaboration and license agreement with AbCellera Biologics Inc. (AbCellera) to discover therapeutic antibodies for up to 10 targets selected by the Company. The partnership will help to expand Company’s portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology and the renal space.
In January 2022, we entered into a global licensing agreement with Singapore’s national platform for drug discovery and development, the EDDC for the exclusive worldwide rights to develop, manufacture and commercialize EDDC’s series of viral 3C-like (3CL) protease inhibitors as a potentially best-in-class oral antiviral treatment against SARS-CoV-2 and its variants. The Company has full rights to sub-license the drug further and will receive a full technology transfer.
Financial Highlights
IFRS Numbers:
Research and development ("R&D") expenses increased by RMB236.0 million to RMB613.4 million for the year ended 31 December 2021, from RMB377.4 million for the year ended 31 December 2020, primarily due to: (i) increased number of clinical trials for our drug candidates; (ii) expansion of internal discovery team to build up in-house R&D capabilities; and (iii) increased costs occurred in the process of technical transfer for our drug candidates.
General and administrative expenses decreased by RMB35.1 million to RMB242.7 million for the year ended 31 December 2021, from RMB277.8 million for the year ended 31 December 2020, primarily due to decreased expenses in relation to the public listing of the Company in 2020.
Distribution and selling expenses increased by RMB165.0 million to RMB198.2 million for the year ended 31 December 2021, from RMB33.2 million for the year ended 31 December 2020, primarily due to expansion of commercial organization and pre-launch and launch activities carried out for product commercialization.
Net loss for the year ended 31 December 2021 was RMB1,008.7 million, from RMB5,658.2 million for the year ended 31 December 2020, primarily attributable to the decrease in loss from fair value change in financial instruments issued to investors.
Cash and cash equivalents amounted to RMB2,640.1 million as of 31 December 2021
Non-IFRS Measure
Adjusted loss for the year[1] was RMB777.3 million for the year ended 31 December 2021, representing an increase of RMB174.4 million from RMB602.9 million for the year ended 31 December 2020, primarily due to increase in R&D expense and distribution and selling expenses.
Conference Call Information
A live conference call will be hosted on March 29, 2022 at 9:00 AM Beijing Time (March 28, 2022 at 9:00 PM U.S. Eastern Time).
The live webcast of the conference call will be available at View Source
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A replay will be available shortly after the call and can be accessed by visiting the Company’s website at View Source