Aankondiging • Apr 08
Genetron Holdings Files Form 15 Genetron Holdings Limited has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its ordinary shares, par value $0.0001 per share, American depositary shares, each representing 15 ordinary shares under the Securities Exchange Act of 1934, as amended. Aankondiging • Mar 30
Genetron Holdings Requests Nasdaq to File Form 25 with the Securities and Exchange Commission for Delisting of the ADSs on Nasdaq and the Deregistration of its Registered Securities Genetron Holdings Limited (‘Genetron Health’ or the ‘Company’) announced the completion of its merger (the ‘Merger’) with Genetron New Co Limited (‘Merger Sub’), pursuant to the previously announced agreement and plan of merger, dated as of October 11, 2023 (the ‘Merger Agreement’), among the Company, New Genetron Holding Limited (‘Parent’) and Merger Sub. As a result of the Merger, the Company has become a wholly owned subsidiary of Parent and will cease to be a publicly traded company. Pursuant to the terms of the Merger Agreement, which was approved by the Company’s shareholders at an extraordinary general meeting held on February 21, 2024, each ordinary share, par value USD 0.00002 per share, of the Company (each, a ‘Share’) issued, outstanding and not represented by American depositary share of the Company (each, an ‘ADS,’ representing fifteen (15) Shares) immediately prior to the effective time of the Merger (the ‘Effective Time’), other than the Excluded Shares and the Dissenting Shares (each as defined in the Merger Agreement), has been cancelled and ceased to exist, in exchange for the right to receive USD 0.272 in cash per Share without interest (the ‘Per Share Merger Consideration’), and each ADS, issued and outstanding immediately prior to the Effective Time, other than ADSs representing the Excluded Shares, together with each Share represented by such ADS, has been cancelled and ceased to exist, in exchange for the right to receive USD 4.08 in cash per ADS without interest (less applicable fees, charges and expenses payable by ADS holders, and such consideration, together with the Per Share Merger Consideration, the ‘Merger Consideration’). The Company also announced that it has requested that trading of its ADSs on the Nasdaq Global Market (the ‘Nasdaq’) be suspended as of the close of trading on March 28, 2024 (New York time). The Company has requested that Nasdaq file a Form 25 with the Securities and Exchange Commission (the ‘SEC’) notifying the SEC of the delisting of the ADSs on Nasdaq and the deregistration of the Company’s registered securities. The deregistration will become effective 90 days after the filing of the Form 25 or such shorter period as may be determined by the SEC. The Company intends to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended, by filing a Form 15 with the SEC in approximately ten days following the filing of the Form 25. The Company’s obligations to file with the SEC certain reports and forms, including Form 20-F and Form 6-K, will be suspended immediately as of the filing date of the Form 15 and will cease once the deregistration becomes effective. New Risk • Oct 12
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 4.7% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Shareholders have been diluted in the past year (4.7% increase in shares outstanding). Market cap is less than US$100m (US$89.2m market cap). Aankondiging • May 24
Genetron Health Announces Receipt of Notification from Nasdaq Regarding Non-Compliance with Minimum Bid Price Requirement of its American Depositary Shares On May 23, 2023, Genetron Holdings Limited announced that it has received written notification from the staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC (‘Nasdaq’) dated May 17, 2023, indicating that for the last 30 consecutive business days, the closing bid price for the Company’s American depositary shares (the ‘ADSs’) was below the minimum bid price of USD 1.00 per share requirement set forth in Nasdaq Listing Rule 5450(a)(1). The Nasdaq notification letter has no current effect on the listing or trading of the Company’s securities on Nasdaq. Pursuant to the Nasdaq Listing Rules 5810(c)(3)(A), the Company is provided with a compliance period of 180 calendar days, or until November 13, 2023, to regain compliance under the Nasdaq Listing Rules. If at any time during the 180-day compliance period, the closing bid price of the Company’s ADSs is USD 1.00 per share or higher for a minimum of ten consecutive business days, Nasdaq will provide the Company written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance by November 13, 2023, subject to the determination by the staff of Nasdaq, the Company may be eligible for an additional 180-day compliance period. The Company’s business operations are not affected by the Nasdaq notification letter. The Company intends to monitor the closing bid price of its ADSs between now and November 13, 2023 and will take all reasonable measures in order to regain compliance with the Nasdaq minimum bid price requirement. Reported Earnings • May 14
Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2022 results: CN¥8.70 loss per share (further deteriorated from CN¥5.39 loss in FY 2021). Revenue: CN¥650.7m (up 22% from FY 2021). Net loss: CN¥808.4m (loss widened 63% from FY 2021). Revenue exceeded analyst estimates by 11%. Earnings per share (EPS) missed analyst estimates by 20%. Revenue is forecast to grow 16% p.a. on average during the next 2 years, compared to a 19% growth forecast for the Biotechs industry in the US. Aankondiging • Jan 19
Genetron Health Regains Compliance with Nasdaq Minimum Bid Price Requirement Genetron Holdings Limited announced that the Company had received a notification letter (“Compliance Notice”) from the staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”), dated January 17, 2023, indicating that the Company has regained compliance with the minimum bid price requirement set forth under the Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”). As previously announced, the Company was notified by Nasdaq on October 28, 2022 that the Company was not in compliance with the Minimum Bid Price Requirement as the bid price of the Company’s American depositary shares (“ADSs”) closed below $1.00 per share for 30 consecutive business days. On January 17, 2023, Nasdaq confirmed in the Compliance Notice that for the ten consecutive business days, from December 29, 2022 to January 13, 2023, the closing bid price of the Company’s ADSs has been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5450(a)(1), and the matter is closed. Board Change • Nov 16
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Director Dian Kang was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Aankondiging • Nov 08
Genetron Health Announces Receipt of Notification from Nasdaq Regarding Minimum Bid Price Genetron Holdings Limited ("Genetron Health" or the "Company") announced that it has received written notification from the staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) dated October 28, 2022, indicating that for the last 30 consecutive business days, the closing bid price for the Company’s American depositary shares (the “ADSs”) was below the minimum bid price of USD 1.00 per share requirement set in Nasdaq Listing Rule 5450(a)(1). The Nasdaq notification letter has no current effect on the listing or trading of the Company’s securities on Nasdaq. Pursuant to the Nasdaq Listing Rules 5810(c)(3)(A), the Company is provided with a compliance period of 180 calendar days, or until April 26, 2023, to regain compliance under the Nasdaq Listing Rules. If at any time during the 180-day compliance period, the closing bid price of the Company’s ADSs is US$1.00 per share or higher for a minimum of ten consecutive business days, Nasdaq will provide the Company written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance by April 26, 2023, subject to the determination by the staff of Nasdaq, the Company may be eligible for an additional 180-day compliance period. The Company’s business operations are not affected by the Nasdaq notification letter. The Company intends to monitor the closing bid price of its ADSs between now and April 26, 2023 and will take all reasonable measures in order to regain compliance with the Nasdaq minimum bid price requirement. Reported Earnings • Oct 12
Second quarter 2022 earnings released: CN¥2.54 loss per share (vs CN¥1.00 loss in 2Q 2021) Second quarter 2022 results: CN¥2.54 loss per share (further deteriorated from CN¥1.00 loss in 2Q 2021). Revenue: CN¥137.7m (down 1.9% from 2Q 2021). Net loss: CN¥235.2m (loss widened 156% from 2Q 2021). Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Aankondiging • Aug 23
Sizhen Wang made a non binding proposal to acquire the remaining 49.2% stake in Genetron Holdings Limited (NasdaqGM:GTH) from Genetron Health (Hong Kong) Company Limited and others for $60 million. Sizhen Wang made a non binding proposal to acquire the remaining 49.2% stake in Genetron Holdings Limited (NasdaqGM:GTH) from Genetron Health (Hong Kong) Company Limited and others for $60 million on August 21, 2022. The deal will be funded by a mix of debt and rollover equity capital by third party sponsors. A special committee consisting Wing Kee Lau and Dian Kang has been formed to evaluate and consider the Proposed Transaction as well as other potential strategic alternatives. The Special Committee intends to retain advisors, including an independent financial advisor and independent legal counsel, to assist it in its evaluation. Aankondiging • Jun 02
Genetron Holdings Limited to Report Q1, 2022 Results on Jun 02, 2022 Genetron Holdings Limited announced that they will report Q1, 2022 results Pre-Market on Jun 02, 2022 Reported Earnings • May 01
Full year 2021 earnings: EPS misses analyst expectations Full year 2021 results: CN¥5.39 loss per share (up from CN¥50.92 loss in FY 2020). Revenue: CN¥532.0m (up 25% from FY 2020). Net loss: CN¥496.2m (loss narrowed 84% from FY 2020). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 7.3%. Over the next year, revenue is forecast to grow 17%, compared to a 44% growth forecast for the pharmaceuticals industry in the US. Price Target Changed • Apr 27
Price target decreased to US$6.51 Down from US$8.84, the current price target is an average from 3 analysts. New target price is 256% above last closing price of US$1.83. Stock is down 92% over the past year. The company is forecast to post a net loss per share of CN¥1.08 next year compared to a net loss per share of CN¥5.39 last year. Major Estimate Revision • Apr 27
Consensus EPS estimates fall by 24% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from CN¥638.3m to CN¥621.2m. Losses expected to increase from CN¥0.87 per share to CN¥1.08. Biotechs industry in the US expected to see average net income decline 47% next year. Consensus price target down from US$8.84 to US$6.51. Share price fell 16% to US$1.83 over the past week. Board Change • Apr 27
Less than half of directors are independent There are 7 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. 3 independent directors (5 non-independent directors). Non-Executive Director Xia Wu is the most experienced director on the board, commencing their role in 2017. Independent Director Dian Kang was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Major Estimate Revision • Apr 21
Consensus EPS estimates fall by 24% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from CN¥638.3m to CN¥621.2m. Losses expected to increase from CN¥0.87 per share to CN¥1.08. Biotechs industry in the US expected to see average net income decline 45% next year. Consensus price target down from US$8.84 to US$6.51. Share price fell 8.6% to US$2.02 over the past week. Major Estimate Revision • Apr 05
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from CN¥718.4m to CN¥632.7m. EPS estimate increased from -CN¥1.01 to -CN¥0.87 per share. Biotechs industry in the US expected to see average net income decline 47% next year. Consensus price target down from US$14.51 to US$11.00. Share price fell 20% to US$2.34 over the past week. Reported Earnings • Mar 30
Full year 2021 earnings: EPS exceeds analyst expectations Full year 2021 results: CN¥5.39 loss per share (up from CN¥50.92 loss in FY 2020). Revenue: CN¥532.0m (up 25% from FY 2020). Net loss: CN¥496.2m (loss narrowed 84% from FY 2020). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 7.3%. Over the next year, revenue is forecast to grow 36%, compared to a 65% growth forecast for the pharmaceuticals industry in the US. Aankondiging • Mar 30
Genetron Holdings Limited Reports Impairment Charges for the Fourth Quarter Ended December 31, 2021 Genetron Holdings Limited reported impairment charges for the fourth quarter ended December 31, 2021. For the quarter, the company reported net impairment losses on financial and contract assets of RMB 13,291,000 against RMB 12,746,000 a year ago. Aankondiging • Jan 12
Genetron Holdings Limited Reiterates Full Year 2021 Revenue Guidance Genetron Holdings Limited reiterated its full year 2021 revenue guidance. The Company expects full year 2021 revenue to be around RMB 530 million, representing approximately 25% growth over the Company’s full year 2020 revenue. Recent Insider Transactions Derivative • Dec 31
Chief Technology Officer notifies of intention to sell stock Yuchen Jiao intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 31st of December. If the sale is conducted around the recent share price of US$8.06, it would amount to US$161k. Since March 2021, Yuchen has owned 651.80k shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Recent Insider Transactions Derivative • Dec 18
Chief Financial Officer notifies of intention to sell stock Ce Xu intends to sell 35k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of December. If the sale is conducted around the recent share price of US$7.00, it would amount to US$245k. As of today, Ce currently holds no shares directly (This sale likely refers to shares that have not yet been received). There have been no trades via on-market transactions or options from company insiders in the last 12 months. Recent Insider Transactions Derivative • Dec 06
Chief Financial Officer notifies of intention to sell stock Ce Xu intends to sell 60k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of December. If the sale is conducted around the recent share price of US$9.14, it would amount to US$548k. As of today, Ce currently holds no shares directly (This sale likely refers to shares that have not yet been received). There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • Dec 03
Third quarter 2021 earnings: EPS and revenues exceed analyst expectations Third quarter 2021 results: CN¥1.40 loss per share (down from CN¥0.53 loss in 3Q 2020). Revenue: CN¥152.5m (up 36% from 3Q 2020). Net loss: CN¥129.0m (loss widened 169% from 3Q 2020). Revenue exceeded analyst estimates by 2.9%. Earnings per share (EPS) also surpassed analyst estimates by 462%. Earnings per share (EPS) surpassed analyst estimates by 462%. Over the next year, revenue is forecast to grow 49%, compared to a 440% growth forecast for the industry in the US. Major Estimate Revision • Dec 02
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from CN¥605.7m to CN¥525.4m. EPS estimate unchanged at -CN¥2.21 per share. Biotechs industry in the US expected to see average net income decline 10.0% next year. Consensus price target down from US$22.40 to US$20.58. Share price fell 13% to US$9.14 over the past week. Price Target Changed • Dec 02
Price target decreased to US$18.92 Down from US$21.92, the current price target is an average from 3 analysts. New target price is 107% above last closing price of US$9.14. Stock is down 33% over the past year. The company is forecast to post a net loss per share of CN¥2.27 next year compared to a net loss per share of CN¥50.92 last year. Aankondiging • Dec 01
Genetron Holdings Limited Provides Revenue Guidance for the Full Year 2021 Genetron Holdings Limited provided revenue guidance for the full year 2021. Based on the continued enforcement of the “zero COVID” strategy in China and the resulting sustained restrictions across Genetron’s major markets, the Company is revising its full year 2021 revenue guidance to be around RMB 530 million, representing approximately 24.9% growth over the Company’s full year 2020 revenue. Price Target Changed • Aug 30
Price target decreased to US$22.63 Down from US$24.96, the current price target is an average from 3 analysts. New target price is 81% above last closing price of US$12.51. Stock is up 1.1% over the past year. Recent Insider Transactions Derivative • Aug 28
Co-Founder notifies of intention to sell stock Hai Yan intends to sell 36k shares in the next 90 days after lodging an Intent To Sell Form on the 27th of August. If the sale is conducted around the recent share price of US$12.40, it would amount to US$444k. Since December 2020, Hai has owned 6.67m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • Aug 25
Second quarter 2021 earnings released The company reported a solid second quarter result with reduced losses, improved revenues and improved control over expenses. Second quarter 2021 results: Revenue: CN¥140.5m (up 38% from 2Q 2020). Net loss: CN¥91.8m (loss narrowed 97% from 2Q 2020). Aankondiging • Aug 25
Genetron Holdings Limited Maintains Revenue Guidance for the Year 2021 Genetron Holdings Limited maintained revenue guidance for the year 2021. At this time, The company expects the current COVID-related restrictions to be temporary, and are maintaining 2021 expected revenue range of RMB 615 million to RMB 625 million. Aankondiging • Jul 15
Genetron Health Limited Receives CE Mark for 8-Gene Lung Cancer Assay and Provides FDA Reference Panel Comparative Data of its SARS-CoV-2 RNA Test Genetron Holdings Limited announced that it has received CE Mark for its 8-gene Lung Cancer Assay. Separately, the Company also reported comparative data showing the sensitivity performance of the Genetron SARS-CoV-2 RNA Test. The CE Mark represents the second regulatory milestone for 8-gene Lung Cancer Assay, as it is already approved by China’s NMPA and is being commercialized in China. This product is based on the Company’s proprietary One-Step Seq Method, offering fast and easy-to-use testing procedures, that is suitable for independent operation within hospitals. With the One-Step Seq technology, the library construction process is finished in one step of reaction, minimizing manual operation to one mixture of reagents with DNA/cDNA. The chance of contamination in the process is minimal with the “sample in library out” workflow. The assay is compatible with the Genetron S5 sequencing platform, and together they offer a two-day turnaround time from sample to report. The 8-gene Lung Cancer Assay covers mutations of EGFR, BRAF, KRAS, HER2 and PIK3CA, translocations of ALK and ROS1, and MET exon 14 skipping, and 7 of these genes are recommended biomarkers by the 2018 NCCN guideline for Non-Small Cell Lung Cancer (NSCLC) patients. Several targeted therapy drugs such as Gefitinib, Osimertinib, Crizotinib and Savolitinib have been approved by the NMPA for treatments of NSCLC patients with those genomic alterations. Separately, the Company also reported comparative performance data of its SARS-CoV-2 RNA Test based on a SARS-CoV-2 reference panel established by the U.S. Food and Drug Administration (FDA). The goal of the reference panel is to allow for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. Results from the blind testing of this panel showed that the sensitivity or limit of detection (LoD) of Genetron’s SARS-CoV-2 RNA Test was 1,800 NDU/mL, which was the best among all domestic companies in China in the same category, and also fared well compared to global companies. Executive Departure • Jul 13
Chief Operating Officer Ying Hong has left the company On the 30th of June, Ying Hong's tenure as Chief Operating Officer ended after 5.5 years in the role. As of March 2021, Ying still personally held 1.06m shares (US$23m worth at the time). A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 3.63 years. Executive Departure • Jul 13
Non-Executive Director Weidong Liu has left the company On the 30th of June, Weidong Liu's tenure as Non-Executive Director ended after 1.7 years in the role. We don't have any record of a personal shareholding under Weidong's name. A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 3.63 years. Aankondiging • May 25
Genetron Holdings Limited Reiterates 2021 Financial Guidance Genetron Holdings Limited announced that based on the current environment and subject to no further major COVID-19-related disruptions in key markets, Genetron Health is reiterating its 2021 revenue to be around RMB 615 million to RMB 625 million, representing around 45%-47% growth over 2020. Reported Earnings • May 25
First quarter 2021 earnings released: CN¥1.23 loss per share (vs CN¥4.62 loss in 1Q 2020) The company reported a solid first quarter result with reduced losses, improved revenues and improved control over expenses. First quarter 2021 results: Revenue: CN¥92.1m (up 20% from 1Q 2020). Net loss: CN¥112.8m (loss narrowed 2.3% from 1Q 2020). Reported Earnings • Apr 10
Full year 2020 earnings released: CN¥50.92 loss per share (vs CN¥27.06 loss in FY 2019) The company reported a mediocre full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: CN¥424.5m (up 31% from FY 2019). Net loss: CN¥3.07b (loss widened 354% from FY 2019). Major Estimate Revision • Apr 01
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 expected loss increased from -CN¥1.63 to -CN¥2.00 per share. Revenue forecast unchanged at CN¥630.1m. Biotechs industry in the US expected to see average net income growth of 3.0% next year. Consensus price target up from US$24.27 to US$26.22. Share price rose 14% to US$21.46 over the past week. Aankondiging • Mar 26
Genetron Holdings Limited Provides Revenue Guidance for Year 2021 Genetron Holdings Limited provided revenue guidance for the year 2021. For the period, the company expects revenue to be around RMB 615 million to RMB 625 million, representing around 45%-47% growth over 2020. Reported Earnings • Mar 26
Full year 2020 earnings released: CN¥50.92 loss per share (vs CN¥27.06 loss in FY 2019) The company reported a mediocre full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: CN¥424.5m (up 31% from FY 2019). Net loss: CN¥3.07b (loss widened 354% from FY 2019). Aankondiging • Mar 05
Genetron Holdings Limited to Report Q4, 2020 Results on Mar 25, 2021 Genetron Holdings Limited announced that they will report Q4, 2020 results Pre-Market on Mar 25, 2021 Is New 90 Day High Low • Feb 09
New 90-day high: US$28.04 The company is up 152% from its price of US$11.11 on 10 November 2020. The American market is up 16% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 25% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$4.26 per share. Is New 90 Day High Low • Jan 20
New 90-day high: US$23.47 The company is up 103% from its price of US$11.55 on 21 October 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 22% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$4.27 per share. Aankondiging • Jan 08
Genetron Health Announces Exclusive Strategic Partnership with Chia Tai Tianqing Pharmaceutical Group Co., Ltd Genetron Holdings Limited and Chia Tai Tianqing Pharmaceutical Group Co. Ltd. announced an exclusive strategic partnership agreement for HCCscreen™, Genetron Health’s blood-based early screening test for hepatocellular carcinoma (“HCC”) in China. This partnership targets the hospital market in China, with a focus on combatting liver disease, and marks Genetron Health’s third key commercialization initiative of HCCscreen™ in the country, complementing its existing sales and marketing strategies through public health programs and medical examination centers. Under the agreement, the companies will work together exclusively to co-market and co-promote HCCscreen™ in the hospital market, covering designated territories in China. The parties intend to target high-risk individuals for HCC, which include HBV-positive carriers, as well as other liver disease patients. CTTQ brings an experienced sales force and valuable hospital relationships to the partnership, while Genetron Health provides manufacturing and laboratory operations for its innovative product, HCCscreen™, along with its direct-to-consumer marketing expertise. Genetron Health will pay CTTQ a promotional fee based on a percentage of revenues generated from the collaboration. Contingent on certain sales and other requirements, the exclusivity period is expected to last three years. As a result of the agreement, Genetron Health expects HCCscreen™ revenues to further accelerate in China. Is New 90 Day High Low • Dec 31
New 90-day high: US$14.00 The company is up 17% from its price of US$12.00 on 02 October 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$3.50 per share. Aankondiging • Nov 28
Genetron Holdings Limited Provides an Update for Hccscreentm, Its Blood-Based Early Screening Test for Hepatocellular Carcinoma (“Hcc”), in China Genetron Holdings Limited provided an update for HCCscreenTM, its blood-based early screening test for hepatocellular carcinoma (“HCC”), in China. Led by the Wuxi municipal government (“Wuxi”) and administered by the National Cancer Center (NCC) in China, the “Liver Cancer Early Screening Comprehensive Prevention and Control Project” is a public health initiative (the “Project”). The goal of the Project is to increase the awareness of liver cancer early screening, and to become a pilot city model in China. For the Project, Wuxi has selected HCCscreenTM for local residents who are high-risk individuals for HCC, and is committed to administering 150,000 tests over a period of three years. Wuxi had entered into a small-scale collaboration agreement with Genetron Health in 2019, and the Project represents an expanded collaboration between the parties. Wuxi is a city in the southern part of Jiangsu Province in eastern China with a population of over six million people, and has emerged as a biopharma innovation hub in recent years. Separately, Genetron Health has formed a new operating center through a joint venture agreement with Wuxi, in which the parties will closely collaborate on advancing the liver cancer early screening market in China, through the adoption of HCCscreenTM. Under this joint venture agreement, both parties will contribute capital, and Genetron Health will own 90% of the joint venture. In addition to the commitment of using HCCscreenTM for its residents, Wuxi will also provide Genetron Health with other supportive measures including rental, R&D subsidies and tax benefits. Is New 90 Day High Low • Nov 26
New 90-day high: US$13.27 The company is up 6.0% from its price of US$12.48 on 27 August 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$4.25 per share. Major Estimate Revision • Nov 11
Analysts increase EPS estimates to -CN¥10.14 The 2020 consensus revenue estimate increased from CN¥412.0m to CN¥421.1m. Analysts raised their EPS forecasts from -CN¥14.43 to -CN¥10.14 in 2020. The Biotechs industry in the US is expected to see an average net income growth of 6.6% next year. The consensus price target of US$19.53 was unchanged from the last update. Share price is up 19% to US$11.11 over the past week. Aankondiging • Oct 28
Genetron Holdings Limited to Report Q3, 2020 Results on Nov 09, 2020 Genetron Holdings Limited announced that they will report Q3, 2020 results on Nov 09, 2020 Aankondiging • Oct 01
Genetron Holdings Limited Receives U.S. FDA Breakthrough Device Designation for its Blood-based NGS Test for Early Detection of Hepatocellular Carcinoma Genetron Holdings Limited announced that its blood-based next-generation sequencing (NGS) test, HCCscreenTM, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). Based on the correspondence with Center for Devices and Radiological Health (CDRH) of the FDA, HCCscreenTM is intended for early detection of hepatocellular carcinoma in individuals who are designated to be at high-risk for HCC due to chronic HBV infection and/or liver cirrhosis. Under the FDA’s Breakthrough Devices Program, the Breakthrough Device designation is granted for products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need. The program is designed to speed up development, assessment and review processes, in order to provide patients with quicker access to those devices. Genetron Health’s HCCscreenTM was granted based on its superior clinical performance over the current standard of care (i.e., ultrasound plus alpha-fetoprotein (AFP)) in a prospective clinical study. With this designation, the Company will have an opportunity to interact with the FDA’s experts to efficiently address topics through the pre-submission process, so as to receive feedback from the FDA and identify areas of agreement in a timely way. It also allows priority review upon premarket approval (PMA) submission, and Medicare coverage by the CMS (Center for Medicare and Medicaid Services) upon formal approval. Genetron Health intends to develop HCCscreenTM as an NGS-based product in the US. The company is also building a lab in Maryland, which it intends to seek CLIA certification, to serve global pharmaceutical companies on R&D and commercialization. In China, HCCscreenTM has recently been commercialized as a lab developed test (LDT). The Company has five laboratories in China, of which the Beijing lab is one of the few domestic labs that are both CAP and CLIA certified. HCCscreen is powered by Genetron Health’s innovative and proprietary Mutation CapsuleTM technology, which enables detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens. Currently, HCCscreen is being tested in its ongoing prospective study with 4,500 HBsAg+ individuals. As of the date of this announcement, 2,000 patients have already completed the study, and preliminary data from 297 patients at one center has demonstrated over 92% sensitivity and 93% specificity, compared to 67% and 99%, respectively in the ultrasound + AFP arm. HCCscreen also achieved a 35% positive predictive value and 99.6% negative predictive value. Furthermore, stratifying by tumor sizes, of the 12 patients identified with HCC in the preliminary dataset, ten patients had tumor sizes of less than five centimeters, indicating HCCscreenTM’s detection ability in early-stage HCCs. The company expects to announce the full data set from all 2,000 patients in the first half of 2021. Aankondiging • Sep 26
Genetron Holdings Limited and Cstone Pharmaceuticals Announce Launch of Clinical Trial in China for Companion Diagnostic Test in Development for Avapritinib Genetron Holdings Limited and its strategic partner CStone Pharmaceuticals announced the launch of a multi-center clinical trial in China for the joint development of a companion diagnostic (CDx) test for avapritinib. This represents a key milestone in the companies’ collaboration. Avapritinib is a kinase inhibitor discovered by CStone’s partner Blueprint Medicines. Genetron Health and CStone are jointly developing a CDx kit to detect the D842V mutation in the human platelet-derived growth factor receptor alpha (PDGFRA) gene using a polymerase chain reaction (PCR)-based method. The CDx test kit utilizes a real-time PCR fluorescent probe, combined with specific primers, Taqman probes, and highly specific Taq enzymes, to detect the mutation with high specificity and sensitivity in DNA samples. The test has been validated by the testing center of the National Medical Products Administration (NMPA) and is now being used in this multi-center clinical trial in China. CStone submitted New Drug Applications for avapritinib in PDGFRA exon 18 mutant gastrointestinal stromal tumors (GIST) to regulatory agencies in Taiwan and Mainland China in March and April 2020, respectively. The Chinese regulatory application has been accepted by the Center for Drug Evaluation (CDE) of NMPA for priority review. Data from the Phase I/II bridging study of avapritinib presented at the Chinese Society of Clinical Oncology (CSCO) annual meeting in 2020 showed that avapritinib was generally well tolerated in Chinese patients, with a safety profile that is consistent with previously published results in global studies. Preliminary results demonstrated the robust clinical activity of avapritinib in Chinese patients with GIST harboring the PDGFRA D842V mutation. Among the eight evaluable patients with PDGFRA D842V mutant GIST who received 300 mg QD doses of avapritinib, all of the patients had evidence of tumor regression in target lesions, and five patients achieved a partial response. The overall response rate (ORR) was 62.5%. The other three patients had stable disease. Is New 90 Day High Low • Sep 22
New 90-day low: US$10.80 The company is down 13% from its price of US$12.48 on 24 June 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Aankondiging • Sep 17
Genetron Health and Dmed Announce Partnership Agreement Genetron Holdings Limited and dMed Biopharmaceutical announced that the two companies have signed a partnership agreement that pioneers a "one-stop" new drug research and development (R&D) service offering and registration services in both China and the U.S. for biopharmaceutical companies. Under the agreement, the two sides will join forces in the field of oncology. Genetron Health will provide its innovative technology and expertise in precision oncology, covering central laboratory services, new drug development and target screening, companion diagnostic development, clinical trial patient screening and enrollment. Meanwhile, dMed will devote its efforts to new drug R&D design, clinical operations, data management and statistical analysis, project management and regulatory affairs. Aankondiging • Jun 20
Genetron Holdings Limited has completed an IPO in the amount of $256 million. Genetron Holdings Limited has completed an IPO in the amount of $256 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 16,000,000
Price\Range: $16
Transaction Features: Sponsor Backed Offering