View Future GrowthThis company has been acquiredThe company may no longer be operating, as it has been acquired. Find out why through their latest events.See Latest EventsChembio Diagnostics 過去の業績過去 基準チェック /06主要情報-34.18%収益成長率-19.53%EPS成長率Medical Equipment 業界の成長8.90%収益成長率14.56%株主資本利益率-130.86%ネット・マージン-47.03%前回の決算情報31 Dec 2022最近の業績更新お知らせ • Oct 21Chembio Diagnostics, Inc. to Report Q3, 2022 Results on Nov 03, 2022Chembio Diagnostics, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2022お知らせ • Jul 22Chembio Diagnostics, Inc. to Report Q2, 2022 Results on Aug 04, 2022Chembio Diagnostics, Inc. announced that they will report Q2, 2022 results After-Market on Aug 04, 2022お知らせ • Apr 22Chembio Diagnostics, Inc. to Report Q1, 2022 Results on May 05, 2022Chembio Diagnostics, Inc. announced that they will report Q1, 2022 results After-Market on May 05, 2022Reported Earnings • Mar 05Full year 2021 earnings: EPS and revenues exceed analyst expectationsFull year 2021 results: US$1.40 loss per share (down from US$1.34 loss in FY 2020). Revenue: US$47.8m (up 47% from FY 2020). Net loss: US$33.9m (loss widened 33% from FY 2020). Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates by 34%. Over the next year, revenue is expected to shrink by 7.8% compared to a 11% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings.お知らせ • Feb 18Chembio Diagnostics, Inc. to Report Q4, 2021 Results on Mar 03, 2022Chembio Diagnostics, Inc. announced that they will report Q4, 2021 results After-Market on Mar 03, 2022Reported Earnings • Nov 06Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.28 loss in 3Q 2020)The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$12.1m (up 17% from 3Q 2020). Net loss: US$6.37m (loss widened 15% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 32% per year and the company’s share price has also fallen by 32% per year.すべての更新を表示Recent updatesお知らせ • Feb 01Biosynex SA (ENXTPA:ALBIO) entered into a definitive merger agreement to acquire Chembio Diagnostics, Inc. (NasdaqCM:CEMI) for $17.2 million.Biosynex SA (ENXTPA:ALBIO) entered into a definitive merger agreement to acquire Chembio Diagnostics, Inc. (NasdaqCM:CEMI) for $17.2 million on January 31, 2023. Under the terms of the merger agreement, Biosynex will initiate a tender offer to acquire all outstanding shares of Chembio. Biosynex will acquire Chembio for $0.45 per share, in an all-cash transaction valued at $17.2 million. Upon the successful completion of the tender offer, any remaining shares of common stock of Chembio will be canceled and converted into the right to receive the same $0.45 per share price payable in the tender offer. Biosynex will operate Chembio and its 100% owned German, Brazil and Malaysia subsidiaries as a wholly owned group. Upon completion, Chembio’s common stock will cease to be traded on The Nasdaq Stock Market LLC. Upon termination of the Merger Agreement under specified circumstances, Chembio must pay Biosynex a termination fee of $850,000 in cash. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Chembio’s outstanding shares and other customary conditions. No vote of Chembio stockholders will be required in connection with the Merger. The terms of the merger agreement were unanimously approved by the Boards of Directors of Chembio and Biosynex, and and the Board of Directors has resolved to recommend to the stockholders of Chembio to accept the Offer and tender their Chembio shares. The transaction is expected to close in the first quarter of 2023. Ernst & Young (EY) is acting as financial advisor and James Hu of White & Case LLP and Marc Petitier and Olivier Pâris of White & Case LLP (Paris) serving as legal counsels to Biosynex. Craig-Hallum Capital Group LLC is acting as financial advisor and Sean M. Jones of K&L Gates LLP is serving as legal counsel to Chembio. Craig-Hallum Capital Group LLC acted as fairness opinion provider to the board of Chembio.お知らせ • Nov 29Chembio Diagnostics, Inc. Announces FDA CLIA Waiver Submission for DPP HIV-Syphilis SystemChembio Diagnostics, Inc. announced the submission to the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DPP HIV-Syphilis System. Co-infection rates of HIV and syphilis are on the rise, according to the CDC, and individuals with an active syphilis infection have an estimated two- to five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that untreated syphilis in pregnant women who contracted the disease during the four years prior to delivery can lead to infection of the fetus in up to 80% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing of women of childbearing age and treatment of infected pregnant women. Chembio's DPP HIV-Syphilis System assists clinicians in diagnosing both HIV and syphilis while patients are still under care at the testing location. The System is a multiplex, single-use, 15-minute test that is designed, in combination with Micro Reader analyzer, to simultaneously detect antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis. The test uses a small, 10-microliter sample of fingerstick whole blood, venous whole blood, or plasma.お知らせ • Oct 21Chembio Diagnostics, Inc. to Report Q3, 2022 Results on Nov 03, 2022Chembio Diagnostics, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2022お知らせ • Oct 07Chembio Diagnostics Receives Written Notice from NasdaqAs previously disclosed, on April 5, 2022, Chembio Diagnostics, Inc. received notification from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, stating that the Company did not comply with the minimum $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2) (the “Listing Rule”). In accordance with Nasdaq listing rules, the Company was afforded 180 calendar days (until October 3, 2022) to regain compliance with the Listing Rule. On October 4, 2022, the Company received written notice from Nasdaq (the “October Notice”) stating that, although the Company had not regained compliance with the minimum bid price requirement by October 3, 2022, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company is eligible for an additional 180 calendar day period, or until April 3, 2023, to regain compliance with the Listing Rule. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-day period. The October Notice has no effect on the listing or trading of the Company’s common stock at this time. The company intends to monitor the closing bid price of its common stock and consider available options to regain compliance with the Bid Price Requirement, which could include seeking to effect a reverse stock split. There can be no assurance that the company will be able to regain compliance with the Bid Price Requirement.Seeking Alpha • Sep 06Chembio gets $3.2M contract from CDC to develop rapid test for syphilisChembio Diagnostics (NASDAQ:CEMI) said it was awarded a $3.2M contract from the Centers for Disease Control and Prevention (CDC) to develop and validate a rapid point-of-care (POC) diagnostic test for syphilis. Chembio will develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and proprietary DPP Micro Reader II. The assay will be intended to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies, the company said in Sept. 6 press release. "We are excited to continue expanding our core sexually transmitted disease portfolio with the syphilis screen and confirm assay,” said Javan Esfandiari, chief science and technology officer, Chembio. CEMI +3.55% to $0.67 premarket Sept. 6Seeking Alpha • Aug 16Chembio stock rises 13% amid plans to develop rapid test for monkeypoxChembio Diagnostics (NASDAQ:CEMI) said it is evaluating the potential to develop a monkeypox rapid point-of-care (POC) test. The company added that it is exploring the technical requirements for test development using its technology platforms, DPP, SURE CHECK, and STAT PAK, along with funding partners. "We are in dialogue with leading health organizations at the federal and state level to evaluate the need for a rapid test to detect and diagnose monkeypox. We are assessing the market needs, timing, regulatory pathway and investment required to develop a test," said Chembio's President and CEO Richard Eberly. CEMI +12.64% to $0.98 premarket Aug. 16お知らせ • Jul 22Chembio Diagnostics, Inc. to Report Q2, 2022 Results on Aug 04, 2022Chembio Diagnostics, Inc. announced that they will report Q2, 2022 results After-Market on Aug 04, 2022お知らせ • May 26Chembio Diagnostics, Inc. Elects Leslie Teso-Lichtman to its Board of DirectorsChembio Diagnostics, Inc. announced the election of Leslie Teso-Lichtman to its Board of Directors at Chembio’s 2022 Annual Meeting of Stockholders. Ms. Teso-Lichtman serves as Senior Vice President and Chief Financial Officer of CereVasc, Inc., where she is responsible for the accounting, finance, and treasury functions, including forecasting and capital planning. Previously, Ms. Teso-Lichtman served as Senior Vice President of Finance and Treasurer for Roche Diagnostics Hematology from 2011 to 2014, following Roche’s acquisition of her former employer Constitutional Medical Investors, Inc. Ms. Teso-Lichtman worked on the integration plan for the new company and to achieve milestones in connection with the acquisition. Prior to her time at Constitutional Medical, Ms. Teso-Lichtman held the role of Vice President and Controller at Cytyc Corporation, which was acquired by Hologic, Inc. in 2007, where she was responsible for all finance and accounting activities, including completing three acquisitions.お知らせ • Apr 22Chembio Diagnostics, Inc. to Report Q1, 2022 Results on May 05, 2022Chembio Diagnostics, Inc. announced that they will report Q1, 2022 results After-Market on May 05, 2022お知らせ • Apr 13Chembio Gets Nasdaq Delisting Notice as Shares Sink Below $1Chembio Diagnostics, Inc. has received a notice that it is out of compliance with Nasdaq Stock Market listing requirements. In a government filing, the company said it had been informed by Nasdaq that its share price had fallen below Nasdaq's $1-per-share minimum for 30 consecutive days. Under Nasdaq rules, Chembio has 180 days — until October 3, 2022 — to regain compliance, though an extension is possible. In the April 7, 2022 filing with the Securities and Exchange Commission, the company said it plans to "monitor" its stock price and will consider actions, including a reverse stock split, to regain compliance. Chembio President and Chief Executive Officer Richard Eberly said in an email that the company was unable to comment beyond the SEC filing.お知らせ • Apr 12Chembio Diagnostics, Inc., Annual General Meeting, May 24, 2022Chembio Diagnostics, Inc., Annual General Meeting, May 24, 2022, at 10:00 US Eastern Standard Time. Agenda: Annual Meeting of Stockholders.お知らせ • Apr 08Chembio Diagnostics Receives Non-Compliance Letter from NasdaqOn April 5, 2022, Chembio Diagnostics, Inc. received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, notifying the company that, for the last thirty consecutive business days, the bid price for shares of the company's common stock had closed below the $1.00 per share minimum bid price requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2), which the company refer to as the Bid Price Requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company have been provided a period of 180 calendar days, or until October 3, 2022, to regain compliance with the Bid Price Requirement. If, at any time before October 3, 2022, the closing bid price for the company's common stock closes at or above $1.00 for a minimum of ten consecutive business days (which number days may be extended by Nasdaq in its discretion to generally no more than twenty consecutive business days), Nasdaq will notify the company that it have regained compliance with the Bid Price Requirement and the matter would be considered resolved. The deficiency letter also indicated that if the company do not regain compliance with the Bid Price Requirement by October 3, 2022, the company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the company would need to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Requirement, and the company would need to provide written notice of the company's intention to cure the deficiency during the additional compliance period, by effecting a reverse stock split, if necessary. If the company meet these requirements, Nasdaq will inform the company that the company have been granted an additional 180 calendar days to regain compliance. Otherwise, including if it appears to the staff of Nasdaq that the company will not be able to cure the deficiency or if the company are not otherwise eligible, Nasdaq will notify the company that its common stock will be subject to delisting. At that time, the company may appeal Nasdaq’s delisting determination to a Nasdaq hearings panel. There can be no assurance that such appeal would be successful. The company intend to monitor the closing bid price of its common stock and consider available options to regain compliance with the Bid Price Requirement, which could include seeking to effect a reverse stock split. There can be no assurance that the company will be able to regain compliance with the Bid Price Requirement.Reported Earnings • Mar 05Full year 2021 earnings: EPS and revenues exceed analyst expectationsFull year 2021 results: US$1.40 loss per share (down from US$1.34 loss in FY 2020). Revenue: US$47.8m (up 47% from FY 2020). Net loss: US$33.9m (loss widened 33% from FY 2020). Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates by 34%. Over the next year, revenue is expected to shrink by 7.8% compared to a 11% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings.お知らせ • Feb 18Chembio Diagnostics, Inc. to Report Q4, 2021 Results on Mar 03, 2022Chembio Diagnostics, Inc. announced that they will report Q4, 2021 results After-Market on Mar 03, 2022お知らせ • Dec 09Chembio Diagnostics, Inc. Receives Notice from the U.S. Food and Drug Administration Require Additional Data Related to Clinical Laboratory Improvement AmendmentOn December 1, 2021, Chembio Diagnostics, Inc. received notice from the U.S. Food and Drug Administration, or FDA, that the FDA would require additional data related to Clinical Laboratory Improvement Amendment, or CLIA, waiver submission for the DPP HIV-Syphilis test system. contract, which refer to as the BARDA Agreement, dated December 2, 2020 with the Biomedical Advanced Research and Development Authority, or BARDA (part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response), expired in accordance with its terms on December 2, 2021. Under the BARDA Agreement, up to $12.7 million of awards were available from BARDA in order to assist in (a) developing, and requesting an EUA from the FDA for, the DPP Respiratory Panel and (b) performing the clinical trials for and submitting the DPP SARS-CoV-2 Antigen test system to the FDA, for 510(k) clearance. As of September 30, 2021 had earned a total of $9.6 million in grant income under the BARDA Agreement, and from October 1, 2021 through December 2, 2021 earned an additional $2.9 million of grant income under the BARDA Agreement. As a result, earned $12.5 million of the $12.7 million available under the BARDA Agreement, with the remaining $0.2 million having not been earned because it was contingent on receiving an emergency use authorization for the DPP Respiratory Panel by December 2, 2021.お知らせ • Nov 30Chembio Diagnostics Receives SAHPRA Approval for DPP SARS-CoV-2 Antigen TestChembio Diagnostics, Inc. announced receipt on November 26, 2021, of South Africa Health Products Regulatory Authority (SAHPRA) approval for the DPP SARS-CoV-2 Antigen test, authorizing marketing and distribution of the test for use at the point-of-care by professional healthcare providers. The DPP SARS-CoV-2 Antigen test has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test uses a minimally invasive nasal swab and is designed to be read visually or with a DPP Micro Reader 2 optical analyzer. Both the DPP SARS-CoV-2 Antigen test and the IgM/IgG Antibody test are authorized for import and distribution in South Africa by Chembios distributor, Patient Focus Africa, pursuant to licenses issued by SAHPRA. PFA is a World Health Organization accredited company for near patient testing, wellness, and professional point of care testing. PFA is partially owned by Discovery Health, and services both the public and private healthcare markets in the country.分析記事 • Nov 30Is Chembio Diagnostics (NASDAQ:CEMI) Using Debt In A Risky Way?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...Reported Earnings • Nov 06Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.28 loss in 3Q 2020)The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$12.1m (up 17% from 3Q 2020). Net loss: US$6.37m (loss widened 15% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 32% per year and the company’s share price has also fallen by 32% per year.お知らせ • Sep 24Chembio Diagnostics, Inc. Announces EUA Submission for DPP Respiratory Antigen PanelChembio Diagnostics, Inc. announced the submission of an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for the company’s DPP Respiratory Antigen Panel test system. The DPP Respiratory Antigen Panel test system is designed to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from a single patient sample using a simple nasal swab. The test system is expected to provide results in approximately 20 minutes and be read on Chembio’s DPP Micro Reader analyzer. The system is intended to enable appropriate clinical management of patients with suspected respiratory infections and to assist in the containment of COVID-19 cases during the flu season. The DPP Respiratory Antigen Panel test system was developed with funds and support as part of a $12.7 million contract awarded by Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The contract also supports preparation of a submission to the FDA in pursuit of 510(k) clearance for the DPP SARS-CoV-2 Antigen test system. Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples such as respiratory samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests. Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, Agência Nacional de Vigilância Sanitária (ANVISA), and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions. All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.お知らせ • Aug 28Chembio Launches Commercial Distribution of Third-Party COVID-19 Antigen AssayChembio Diagnostics, Inc. announced its launch of commercial distribution of an FDA Emergency Use Authorized, patent pending, rapid point-of-care COVID-19 antigen test for use in decentralized and traditional testing settings. Product inventory is on-hand and immediately available for shipment to Chembio customers across the United States. The SCoV-2 Ag Detect Rapid Test, manufactured by InBios International, Inc., is a rapid immunoassay test authorized for use in laboratories with a CLIA waiver certification. It provides results in 20 minutes from a nasal swab and requires no instrumentation. The test can be used for both patients who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset and for asymptomatic serial testing.Reported Earnings • Aug 09Second quarter 2021 earnings released: US$0.45 loss per share (vs US$0.42 loss in 2Q 2020)The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$6.46m (up 26% from 2Q 2020). Net loss: US$9.06m (loss widened 16% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 38% per year whereas the company’s share price has fallen by 36% per year.分析記事 • Aug 08Analysts' Revenue Estimates For Chembio Diagnostics, Inc. (NASDAQ:CEMI) Are Surging HigherShareholders in Chembio Diagnostics, Inc. ( NASDAQ:CEMI ) may be thrilled to learn that the analysts have just...Major Estimate Revision • Aug 07Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$36.1m to US$40.4m. EPS estimate unchanged from -US$0.92 at last update. Medical Equipment industry in the US expected to see average net income growth of 20% next year. Consensus price target of US$6.00 unchanged from last update. Share price rose 6.0% to US$3.01 over the past week.分析記事 • Jul 22Does Chembio Diagnostics (NASDAQ:CEMI) Have A Healthy Balance Sheet?Legendary fund manager Li Lu (who Charlie Munger backed) once said, 'The biggest investment risk is not the volatility...お知らせ • Jun 28+ 8 more updatesChembio Diagnostics, Inc.(NasdaqCM:CEMI) dropped from Russell 3000E Value IndexChembio Diagnostics, Inc.(NasdaqCM:CEMI) dropped from Russell 3000E Value IndexReported Earnings • May 10First quarter 2021 earnings released: US$0.22 loss per share (vs US$0.29 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: US$8.72m (up 27% from 1Q 2020). Net loss: US$4.50m (loss narrowed 10.0% from 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 40% per year but the company’s share price has only fallen by 27% per year, which means it has not declined as severely as earnings.Major Estimate Revision • May 09Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$36.7m to US$36.1m. 2021 losses expected to reduce from -US$1.15 to -US$1.01 per share. Medical Equipment industry in the US expected to see average net income growth of 28% next year. Consensus price target down from US$9.00 to US$8.00. Share price fell 14% to US$3.42 over the past week.Executive Departure • May 05Independent Director has left the companyOn the 23rd of April, Mary Polan's tenure as Independent Director ended after 2.7 years in the role. We don't have any record of a personal shareholding under Mary's name. Mary is the only executive to leave the company over the last 12 months.分析記事 • Apr 07Is Chembio Diagnostics (NASDAQ:CEMI) Using Debt Sensibly?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...Recent Insider Transactions Derivative • Mar 20President exercised options and sold US$115k worth of stockOn the 16th of March, Richard Eberly exercised options to acquire 78k shares at no cost and sold these for an average price of US$1.48 per share. This trade did not impact their existing holding. As of today, Richard currently holds no shares directly. This was the only transaction from an insider over the last 12 months.Reported Earnings • Mar 13Full year 2020 earnings released: US$1.34 loss per share (vs US$0.81 loss in FY 2019)The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$32.5m (down 5.8% from FY 2019). Net loss: US$25.5m (loss widened 87% from FY 2019). Over the last 3 years on average, earnings per share has fallen by 40% per year but the company’s share price has only fallen by 18% per year, which means it has not declined as severely as earnings.Analyst Estimate Surprise Post Earnings • Mar 13Revenue and earnings beat expectationsRevenue exceeded analyst estimates by 16%. Earnings per share (EPS) also surpassed analyst estimates by 7.8%. Over the next year, revenue is forecast to grow 10%, compared to a 21% growth forecast for the Medical Equipment industry in the US.お知らせ • Mar 09Chembio Diagnostics Announces Board ChangesChembio Diagnostics, Inc. announced the appointment of David Bespalko to the Company’s Board of Directors, effective upon his election on March 4, 2021. Mr. Bespalko brings over 35 years of leadership experience in the global in vitro diagnostics market. Most recently he was Group Vice President, Global Commercial Operations Specialty Diagnostics Group at Thermo Fisher Scientific, which he joined in 2011 as President of Fisher Healthcare. During his tenure there, Mr. Bespalko held additional roles such as President of the Global Anatomical Pathology Division. Previously, Mr. Bespalko was Corporate Vice President, North America Commercial Operations at Beckman Coulter. Also on March 4, 2021, Dr. Mary Lake Polan informed the Board of Directors that she would not stand for reelection to the Board at the Company’s 2021 Annual Meeting of Shareholders.Is New 90 Day High Low • Mar 05New 90-day low: US$4.36The company is down 33% from its price of US$6.46 on 04 December 2020. The American market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 1.0% over the same period.お知らせ • Feb 26Chembio Diagnostics, Inc. to Report Q4, 2020 Results on Mar 11, 2021Chembio Diagnostics, Inc. announced that they will report Q4, 2020 results After-Market on Mar 11, 2021Is New 90 Day High Low • Feb 05New 90-day high: US$7.58The company is up 60% from its price of US$4.74 on 06 November 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 8.0% over the same period.分析記事 • Jan 16Is Chembio Diagnostics, Inc.'s (NASDAQ:CEMI) Shareholder Ownership Skewed Towards Insiders?If you want to know who really controls Chembio Diagnostics, Inc. ( NASDAQ:CEMI ), then you'll have to look at the...お知らせ • Dec 19Chembio Diagnostics, Inc. Appoints David Acheson, M.D. to Its Board of DirectorsChembio Diagnostics, Inc. announced the appointment of David Acheson, M.D. to the Company’s Board of Directors. Dr. David Acheson has served as the President and Chief Executive Officer of The Acheson Group since founding the global food safety consulting group in 2013. Previously he served as a Partner and Managing Director of Leavitt Partners, where he founded and managed the firm’s food safety services business.分析記事 • Dec 12Is Chembio Diagnostics (NASDAQ:CEMI) Weighed On By Its Debt Load?Warren Buffett famously said, 'Volatility is far from synonymous with risk.' It's only natural to consider a company's...Price Target Changed • Dec 04Price target raised to US$9.00Up from US$6.00, the current price target is an average from 3 analysts. The new target price is 20% above the current share price of US$7.51. As of last close, the stock is up 88% over the past year.お知らせ • Dec 03Chembio Diagnostics Wins $12.7 Million Contract by BARDA for Development of Rapid DPP Respiratory Antigen Panel and 510(k) Submission of the Rapid DPP SARS-CoV-2 Antigen Test SystemChembio Diagnostics, Inc. announced it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The contract will support the development and pursuit of U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system using Chembio’s proprietary DPP technology for the upcoming flu season. The contract also supports preparation of a submission in pursuit of FDA 510(k) clearance for the rapid DPP SARS-CoV-2 Antigen test system that was recently submitted to the FDA for an EUA. The award totals $12,691,726. A second portion of the contract will support the verification, process validation, and production of clinical validation data to be included in a submission to the FDA for 510(k) clearance and CLIA-waiver for the DPP SARS-CoV-2 Antigen test system. This system consists of a DPP SARS-CoV-2 Antigen test cartridge and a DPP Micro Reader analyzer and is designed to use a minimally invasive nasal swab to detect SARS-CoV-2 viral antigens in only 20 minutes. The system was developed by Chembio and submitted to the FDA for an EUA on October 15, 2020, with support from BARDA under contract number 75A50120C00138.Is New 90 Day High Low • Dec 01New 90-day high: US$5.74The company is up 47% from its price of US$3.90 on 01 September 2020. The American market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.Major Estimate Revision • Nov 12Analysts update estimatesThe 2020 consensus revenue estimate increased from US$21.1m to US$28.0m. Earning per share (EPS) estimate was further reduced from -US$1.17 to -US$1.24 for the same period. The Medical Equipment industry in the US is expected to see an average net income growth of 19% next year. The consensus price target of US$6.25 was unchanged from the last update. Share price is up 1.1% to US$4.48 over the past week.Reported Earnings • Nov 08Third quarter 2020 earnings released: US$0.28 loss per shareThe company reported a soft third quarter result with increased losses and weaker control over expenses, although revenues were improved. Third quarter 2020 results: Revenue: US$10.3m (up 5.7% from 3Q 2019). Net loss: US$5.54m (loss widened 46% from 3Q 2019). Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 11% per year, which means it has not declined as severely as earnings.Analyst Estimate Surprise Post Earnings • Nov 08Revenue and earnings beat expectationsRevenue exceeded analyst estimates by 162%. Earnings per share (EPS) also surpassed analyst estimates by 7.7%. Over the next year, revenue is forecast to grow 11%, compared to a 16% growth forecast for the Medical Equipment industry in the US.お知らせ • Oct 16Chembio Diagnostics, Inc. Submits EUA Application for DPP SARS-CoV-2 Antigen Test SystemChembio Diagnostics, Inc. announced the submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2 Antigen test system, which has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyzer and a minimally-invasive nasal swab.お知らせ • Oct 03Chembio Diagnostics, Inc Receives FDA Approval for DPP HIV-Syphilis SystemChembio Diagnostics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Premarket Approval (PMA) application for the DPP HIV-Syphilis System. The system includes the DPP HIV-Syphilis assay, a multiplex single-use test, and the DPP Micro Reader optical analyzer, and is being offered in the United States immediately. Co-infection rates of HIV and syphilis are on the rise and, according to the U.S. Centers for Disease Control and Prevention (CDC), individuals with an active syphilis infection have an estimated two-to-five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that untreated syphilis in pregnant women who acquired the disease during the four years before delivery can lead to infection of the fetus in up to 80% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis has increased by 185.3% from 2014 to 2018, consistent with the 165.4% increase in active syphilis infections among reproductive-aged women during the same period. Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing and treatment of infected pregnant women. Chembio’s DPP HIV-Syphilis System assists clinicians in diagnosing HIV or syphilis while patients are still at a POC setting. According to the U.S. Department of Health & Human Services, one in eight people living with HIV in the United States are unaware of their infection, and improving access to HIV testing can help more people learn their status so they can be connected to care and treatment. The CDC recommends that individuals at higher risk of HIV infection be tested at least annually.お知らせ • Jul 24Chembio Diagnostics, Inc. to Report Q2, 2020 Results on Aug 06, 2020Chembio Diagnostics, Inc. announced that they will report Q2, 2020 results at 5:00 PM, Eastern Standard Time on Aug 06, 2020収支内訳Chembio Diagnostics の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史NasdaqCM:CEMI 収益、費用、利益 ( )USD Millions日付収益収益G+A経費研究開発費31 Dec 2250-2324030 Sep 2260-3625030 Jun 2261-3625-231 Mar 2258-3826031 Dec 2148-3425030 Sep 2137-2725030 Jun 2136-2625631 Mar 2134-2523031 Dec 2032-2621030 Sep 2029-2217030 Jun 2028-2116031 Mar 2033-1616031 Dec 1934-1416030 Sep 1935-1316030 Jun 1937-1114031 Mar 1935-1013031 Dec 1835-811030 Sep 1833-710030 Jun 1830-59031 Mar 1825-59031 Dec 1724-69030 Sep 1722-79-630 Jun 1718-89-431 Mar 1718-158-231 Dec 1618-138030 Sep 1618-117830 Jun 1621-1077質の高い収益: CEMIは現在利益が出ていません。利益率の向上: CEMIは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: CEMIは利益が出ておらず、過去 5 年間で損失は年間34.2%の割合で増加しています。成長の加速: CEMIの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: CEMIは利益が出ていないため、過去 1 年間の収益成長をMedical Equipment業界 ( 14.8% ) と比較することは困難です。株主資本利益率高いROE: CEMIは現在利益が出ていないため、自己資本利益率 ( -130.86% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YHealthcare 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2023/04/27 03:37終値2023/04/27 00:00収益2022/12/31年間収益2022/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Chembio Diagnostics, Inc. これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。5 アナリスト機関Catherine Ramsey SchulteBairdRaymond MyersBenchmark CompanyMark MassaroCanaccord Genuity2 その他のアナリストを表示
お知らせ • Oct 21Chembio Diagnostics, Inc. to Report Q3, 2022 Results on Nov 03, 2022Chembio Diagnostics, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2022
お知らせ • Jul 22Chembio Diagnostics, Inc. to Report Q2, 2022 Results on Aug 04, 2022Chembio Diagnostics, Inc. announced that they will report Q2, 2022 results After-Market on Aug 04, 2022
お知らせ • Apr 22Chembio Diagnostics, Inc. to Report Q1, 2022 Results on May 05, 2022Chembio Diagnostics, Inc. announced that they will report Q1, 2022 results After-Market on May 05, 2022
Reported Earnings • Mar 05Full year 2021 earnings: EPS and revenues exceed analyst expectationsFull year 2021 results: US$1.40 loss per share (down from US$1.34 loss in FY 2020). Revenue: US$47.8m (up 47% from FY 2020). Net loss: US$33.9m (loss widened 33% from FY 2020). Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates by 34%. Over the next year, revenue is expected to shrink by 7.8% compared to a 11% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings.
お知らせ • Feb 18Chembio Diagnostics, Inc. to Report Q4, 2021 Results on Mar 03, 2022Chembio Diagnostics, Inc. announced that they will report Q4, 2021 results After-Market on Mar 03, 2022
Reported Earnings • Nov 06Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.28 loss in 3Q 2020)The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$12.1m (up 17% from 3Q 2020). Net loss: US$6.37m (loss widened 15% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 32% per year and the company’s share price has also fallen by 32% per year.
お知らせ • Feb 01Biosynex SA (ENXTPA:ALBIO) entered into a definitive merger agreement to acquire Chembio Diagnostics, Inc. (NasdaqCM:CEMI) for $17.2 million.Biosynex SA (ENXTPA:ALBIO) entered into a definitive merger agreement to acquire Chembio Diagnostics, Inc. (NasdaqCM:CEMI) for $17.2 million on January 31, 2023. Under the terms of the merger agreement, Biosynex will initiate a tender offer to acquire all outstanding shares of Chembio. Biosynex will acquire Chembio for $0.45 per share, in an all-cash transaction valued at $17.2 million. Upon the successful completion of the tender offer, any remaining shares of common stock of Chembio will be canceled and converted into the right to receive the same $0.45 per share price payable in the tender offer. Biosynex will operate Chembio and its 100% owned German, Brazil and Malaysia subsidiaries as a wholly owned group. Upon completion, Chembio’s common stock will cease to be traded on The Nasdaq Stock Market LLC. Upon termination of the Merger Agreement under specified circumstances, Chembio must pay Biosynex a termination fee of $850,000 in cash. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Chembio’s outstanding shares and other customary conditions. No vote of Chembio stockholders will be required in connection with the Merger. The terms of the merger agreement were unanimously approved by the Boards of Directors of Chembio and Biosynex, and and the Board of Directors has resolved to recommend to the stockholders of Chembio to accept the Offer and tender their Chembio shares. The transaction is expected to close in the first quarter of 2023. Ernst & Young (EY) is acting as financial advisor and James Hu of White & Case LLP and Marc Petitier and Olivier Pâris of White & Case LLP (Paris) serving as legal counsels to Biosynex. Craig-Hallum Capital Group LLC is acting as financial advisor and Sean M. Jones of K&L Gates LLP is serving as legal counsel to Chembio. Craig-Hallum Capital Group LLC acted as fairness opinion provider to the board of Chembio.
お知らせ • Nov 29Chembio Diagnostics, Inc. Announces FDA CLIA Waiver Submission for DPP HIV-Syphilis SystemChembio Diagnostics, Inc. announced the submission to the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DPP HIV-Syphilis System. Co-infection rates of HIV and syphilis are on the rise, according to the CDC, and individuals with an active syphilis infection have an estimated two- to five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that untreated syphilis in pregnant women who contracted the disease during the four years prior to delivery can lead to infection of the fetus in up to 80% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing of women of childbearing age and treatment of infected pregnant women. Chembio's DPP HIV-Syphilis System assists clinicians in diagnosing both HIV and syphilis while patients are still under care at the testing location. The System is a multiplex, single-use, 15-minute test that is designed, in combination with Micro Reader analyzer, to simultaneously detect antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis. The test uses a small, 10-microliter sample of fingerstick whole blood, venous whole blood, or plasma.
お知らせ • Oct 21Chembio Diagnostics, Inc. to Report Q3, 2022 Results on Nov 03, 2022Chembio Diagnostics, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2022
お知らせ • Oct 07Chembio Diagnostics Receives Written Notice from NasdaqAs previously disclosed, on April 5, 2022, Chembio Diagnostics, Inc. received notification from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, stating that the Company did not comply with the minimum $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2) (the “Listing Rule”). In accordance with Nasdaq listing rules, the Company was afforded 180 calendar days (until October 3, 2022) to regain compliance with the Listing Rule. On October 4, 2022, the Company received written notice from Nasdaq (the “October Notice”) stating that, although the Company had not regained compliance with the minimum bid price requirement by October 3, 2022, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company is eligible for an additional 180 calendar day period, or until April 3, 2023, to regain compliance with the Listing Rule. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-day period. The October Notice has no effect on the listing or trading of the Company’s common stock at this time. The company intends to monitor the closing bid price of its common stock and consider available options to regain compliance with the Bid Price Requirement, which could include seeking to effect a reverse stock split. There can be no assurance that the company will be able to regain compliance with the Bid Price Requirement.
Seeking Alpha • Sep 06Chembio gets $3.2M contract from CDC to develop rapid test for syphilisChembio Diagnostics (NASDAQ:CEMI) said it was awarded a $3.2M contract from the Centers for Disease Control and Prevention (CDC) to develop and validate a rapid point-of-care (POC) diagnostic test for syphilis. Chembio will develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and proprietary DPP Micro Reader II. The assay will be intended to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies, the company said in Sept. 6 press release. "We are excited to continue expanding our core sexually transmitted disease portfolio with the syphilis screen and confirm assay,” said Javan Esfandiari, chief science and technology officer, Chembio. CEMI +3.55% to $0.67 premarket Sept. 6
Seeking Alpha • Aug 16Chembio stock rises 13% amid plans to develop rapid test for monkeypoxChembio Diagnostics (NASDAQ:CEMI) said it is evaluating the potential to develop a monkeypox rapid point-of-care (POC) test. The company added that it is exploring the technical requirements for test development using its technology platforms, DPP, SURE CHECK, and STAT PAK, along with funding partners. "We are in dialogue with leading health organizations at the federal and state level to evaluate the need for a rapid test to detect and diagnose monkeypox. We are assessing the market needs, timing, regulatory pathway and investment required to develop a test," said Chembio's President and CEO Richard Eberly. CEMI +12.64% to $0.98 premarket Aug. 16
お知らせ • Jul 22Chembio Diagnostics, Inc. to Report Q2, 2022 Results on Aug 04, 2022Chembio Diagnostics, Inc. announced that they will report Q2, 2022 results After-Market on Aug 04, 2022
お知らせ • May 26Chembio Diagnostics, Inc. Elects Leslie Teso-Lichtman to its Board of DirectorsChembio Diagnostics, Inc. announced the election of Leslie Teso-Lichtman to its Board of Directors at Chembio’s 2022 Annual Meeting of Stockholders. Ms. Teso-Lichtman serves as Senior Vice President and Chief Financial Officer of CereVasc, Inc., where she is responsible for the accounting, finance, and treasury functions, including forecasting and capital planning. Previously, Ms. Teso-Lichtman served as Senior Vice President of Finance and Treasurer for Roche Diagnostics Hematology from 2011 to 2014, following Roche’s acquisition of her former employer Constitutional Medical Investors, Inc. Ms. Teso-Lichtman worked on the integration plan for the new company and to achieve milestones in connection with the acquisition. Prior to her time at Constitutional Medical, Ms. Teso-Lichtman held the role of Vice President and Controller at Cytyc Corporation, which was acquired by Hologic, Inc. in 2007, where she was responsible for all finance and accounting activities, including completing three acquisitions.
お知らせ • Apr 22Chembio Diagnostics, Inc. to Report Q1, 2022 Results on May 05, 2022Chembio Diagnostics, Inc. announced that they will report Q1, 2022 results After-Market on May 05, 2022
お知らせ • Apr 13Chembio Gets Nasdaq Delisting Notice as Shares Sink Below $1Chembio Diagnostics, Inc. has received a notice that it is out of compliance with Nasdaq Stock Market listing requirements. In a government filing, the company said it had been informed by Nasdaq that its share price had fallen below Nasdaq's $1-per-share minimum for 30 consecutive days. Under Nasdaq rules, Chembio has 180 days — until October 3, 2022 — to regain compliance, though an extension is possible. In the April 7, 2022 filing with the Securities and Exchange Commission, the company said it plans to "monitor" its stock price and will consider actions, including a reverse stock split, to regain compliance. Chembio President and Chief Executive Officer Richard Eberly said in an email that the company was unable to comment beyond the SEC filing.
お知らせ • Apr 12Chembio Diagnostics, Inc., Annual General Meeting, May 24, 2022Chembio Diagnostics, Inc., Annual General Meeting, May 24, 2022, at 10:00 US Eastern Standard Time. Agenda: Annual Meeting of Stockholders.
お知らせ • Apr 08Chembio Diagnostics Receives Non-Compliance Letter from NasdaqOn April 5, 2022, Chembio Diagnostics, Inc. received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, notifying the company that, for the last thirty consecutive business days, the bid price for shares of the company's common stock had closed below the $1.00 per share minimum bid price requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2), which the company refer to as the Bid Price Requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company have been provided a period of 180 calendar days, or until October 3, 2022, to regain compliance with the Bid Price Requirement. If, at any time before October 3, 2022, the closing bid price for the company's common stock closes at or above $1.00 for a minimum of ten consecutive business days (which number days may be extended by Nasdaq in its discretion to generally no more than twenty consecutive business days), Nasdaq will notify the company that it have regained compliance with the Bid Price Requirement and the matter would be considered resolved. The deficiency letter also indicated that if the company do not regain compliance with the Bid Price Requirement by October 3, 2022, the company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the company would need to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Requirement, and the company would need to provide written notice of the company's intention to cure the deficiency during the additional compliance period, by effecting a reverse stock split, if necessary. If the company meet these requirements, Nasdaq will inform the company that the company have been granted an additional 180 calendar days to regain compliance. Otherwise, including if it appears to the staff of Nasdaq that the company will not be able to cure the deficiency or if the company are not otherwise eligible, Nasdaq will notify the company that its common stock will be subject to delisting. At that time, the company may appeal Nasdaq’s delisting determination to a Nasdaq hearings panel. There can be no assurance that such appeal would be successful. The company intend to monitor the closing bid price of its common stock and consider available options to regain compliance with the Bid Price Requirement, which could include seeking to effect a reverse stock split. There can be no assurance that the company will be able to regain compliance with the Bid Price Requirement.
Reported Earnings • Mar 05Full year 2021 earnings: EPS and revenues exceed analyst expectationsFull year 2021 results: US$1.40 loss per share (down from US$1.34 loss in FY 2020). Revenue: US$47.8m (up 47% from FY 2020). Net loss: US$33.9m (loss widened 33% from FY 2020). Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates by 34%. Over the next year, revenue is expected to shrink by 7.8% compared to a 11% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings.
お知らせ • Feb 18Chembio Diagnostics, Inc. to Report Q4, 2021 Results on Mar 03, 2022Chembio Diagnostics, Inc. announced that they will report Q4, 2021 results After-Market on Mar 03, 2022
お知らせ • Dec 09Chembio Diagnostics, Inc. Receives Notice from the U.S. Food and Drug Administration Require Additional Data Related to Clinical Laboratory Improvement AmendmentOn December 1, 2021, Chembio Diagnostics, Inc. received notice from the U.S. Food and Drug Administration, or FDA, that the FDA would require additional data related to Clinical Laboratory Improvement Amendment, or CLIA, waiver submission for the DPP HIV-Syphilis test system. contract, which refer to as the BARDA Agreement, dated December 2, 2020 with the Biomedical Advanced Research and Development Authority, or BARDA (part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response), expired in accordance with its terms on December 2, 2021. Under the BARDA Agreement, up to $12.7 million of awards were available from BARDA in order to assist in (a) developing, and requesting an EUA from the FDA for, the DPP Respiratory Panel and (b) performing the clinical trials for and submitting the DPP SARS-CoV-2 Antigen test system to the FDA, for 510(k) clearance. As of September 30, 2021 had earned a total of $9.6 million in grant income under the BARDA Agreement, and from October 1, 2021 through December 2, 2021 earned an additional $2.9 million of grant income under the BARDA Agreement. As a result, earned $12.5 million of the $12.7 million available under the BARDA Agreement, with the remaining $0.2 million having not been earned because it was contingent on receiving an emergency use authorization for the DPP Respiratory Panel by December 2, 2021.
お知らせ • Nov 30Chembio Diagnostics Receives SAHPRA Approval for DPP SARS-CoV-2 Antigen TestChembio Diagnostics, Inc. announced receipt on November 26, 2021, of South Africa Health Products Regulatory Authority (SAHPRA) approval for the DPP SARS-CoV-2 Antigen test, authorizing marketing and distribution of the test for use at the point-of-care by professional healthcare providers. The DPP SARS-CoV-2 Antigen test has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test uses a minimally invasive nasal swab and is designed to be read visually or with a DPP Micro Reader 2 optical analyzer. Both the DPP SARS-CoV-2 Antigen test and the IgM/IgG Antibody test are authorized for import and distribution in South Africa by Chembios distributor, Patient Focus Africa, pursuant to licenses issued by SAHPRA. PFA is a World Health Organization accredited company for near patient testing, wellness, and professional point of care testing. PFA is partially owned by Discovery Health, and services both the public and private healthcare markets in the country.
分析記事 • Nov 30Is Chembio Diagnostics (NASDAQ:CEMI) Using Debt In A Risky Way?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...
Reported Earnings • Nov 06Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.28 loss in 3Q 2020)The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$12.1m (up 17% from 3Q 2020). Net loss: US$6.37m (loss widened 15% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 32% per year and the company’s share price has also fallen by 32% per year.
お知らせ • Sep 24Chembio Diagnostics, Inc. Announces EUA Submission for DPP Respiratory Antigen PanelChembio Diagnostics, Inc. announced the submission of an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for the company’s DPP Respiratory Antigen Panel test system. The DPP Respiratory Antigen Panel test system is designed to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from a single patient sample using a simple nasal swab. The test system is expected to provide results in approximately 20 minutes and be read on Chembio’s DPP Micro Reader analyzer. The system is intended to enable appropriate clinical management of patients with suspected respiratory infections and to assist in the containment of COVID-19 cases during the flu season. The DPP Respiratory Antigen Panel test system was developed with funds and support as part of a $12.7 million contract awarded by Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The contract also supports preparation of a submission to the FDA in pursuit of 510(k) clearance for the DPP SARS-CoV-2 Antigen test system. Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples such as respiratory samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests. Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, Agência Nacional de Vigilância Sanitária (ANVISA), and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions. All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.
お知らせ • Aug 28Chembio Launches Commercial Distribution of Third-Party COVID-19 Antigen AssayChembio Diagnostics, Inc. announced its launch of commercial distribution of an FDA Emergency Use Authorized, patent pending, rapid point-of-care COVID-19 antigen test for use in decentralized and traditional testing settings. Product inventory is on-hand and immediately available for shipment to Chembio customers across the United States. The SCoV-2 Ag Detect Rapid Test, manufactured by InBios International, Inc., is a rapid immunoassay test authorized for use in laboratories with a CLIA waiver certification. It provides results in 20 minutes from a nasal swab and requires no instrumentation. The test can be used for both patients who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset and for asymptomatic serial testing.
Reported Earnings • Aug 09Second quarter 2021 earnings released: US$0.45 loss per share (vs US$0.42 loss in 2Q 2020)The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$6.46m (up 26% from 2Q 2020). Net loss: US$9.06m (loss widened 16% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 38% per year whereas the company’s share price has fallen by 36% per year.
分析記事 • Aug 08Analysts' Revenue Estimates For Chembio Diagnostics, Inc. (NASDAQ:CEMI) Are Surging HigherShareholders in Chembio Diagnostics, Inc. ( NASDAQ:CEMI ) may be thrilled to learn that the analysts have just...
Major Estimate Revision • Aug 07Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$36.1m to US$40.4m. EPS estimate unchanged from -US$0.92 at last update. Medical Equipment industry in the US expected to see average net income growth of 20% next year. Consensus price target of US$6.00 unchanged from last update. Share price rose 6.0% to US$3.01 over the past week.
分析記事 • Jul 22Does Chembio Diagnostics (NASDAQ:CEMI) Have A Healthy Balance Sheet?Legendary fund manager Li Lu (who Charlie Munger backed) once said, 'The biggest investment risk is not the volatility...
お知らせ • Jun 28+ 8 more updatesChembio Diagnostics, Inc.(NasdaqCM:CEMI) dropped from Russell 3000E Value IndexChembio Diagnostics, Inc.(NasdaqCM:CEMI) dropped from Russell 3000E Value Index
Reported Earnings • May 10First quarter 2021 earnings released: US$0.22 loss per share (vs US$0.29 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: US$8.72m (up 27% from 1Q 2020). Net loss: US$4.50m (loss narrowed 10.0% from 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 40% per year but the company’s share price has only fallen by 27% per year, which means it has not declined as severely as earnings.
Major Estimate Revision • May 09Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$36.7m to US$36.1m. 2021 losses expected to reduce from -US$1.15 to -US$1.01 per share. Medical Equipment industry in the US expected to see average net income growth of 28% next year. Consensus price target down from US$9.00 to US$8.00. Share price fell 14% to US$3.42 over the past week.
Executive Departure • May 05Independent Director has left the companyOn the 23rd of April, Mary Polan's tenure as Independent Director ended after 2.7 years in the role. We don't have any record of a personal shareholding under Mary's name. Mary is the only executive to leave the company over the last 12 months.
分析記事 • Apr 07Is Chembio Diagnostics (NASDAQ:CEMI) Using Debt Sensibly?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...
Recent Insider Transactions Derivative • Mar 20President exercised options and sold US$115k worth of stockOn the 16th of March, Richard Eberly exercised options to acquire 78k shares at no cost and sold these for an average price of US$1.48 per share. This trade did not impact their existing holding. As of today, Richard currently holds no shares directly. This was the only transaction from an insider over the last 12 months.
Reported Earnings • Mar 13Full year 2020 earnings released: US$1.34 loss per share (vs US$0.81 loss in FY 2019)The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$32.5m (down 5.8% from FY 2019). Net loss: US$25.5m (loss widened 87% from FY 2019). Over the last 3 years on average, earnings per share has fallen by 40% per year but the company’s share price has only fallen by 18% per year, which means it has not declined as severely as earnings.
Analyst Estimate Surprise Post Earnings • Mar 13Revenue and earnings beat expectationsRevenue exceeded analyst estimates by 16%. Earnings per share (EPS) also surpassed analyst estimates by 7.8%. Over the next year, revenue is forecast to grow 10%, compared to a 21% growth forecast for the Medical Equipment industry in the US.
お知らせ • Mar 09Chembio Diagnostics Announces Board ChangesChembio Diagnostics, Inc. announced the appointment of David Bespalko to the Company’s Board of Directors, effective upon his election on March 4, 2021. Mr. Bespalko brings over 35 years of leadership experience in the global in vitro diagnostics market. Most recently he was Group Vice President, Global Commercial Operations Specialty Diagnostics Group at Thermo Fisher Scientific, which he joined in 2011 as President of Fisher Healthcare. During his tenure there, Mr. Bespalko held additional roles such as President of the Global Anatomical Pathology Division. Previously, Mr. Bespalko was Corporate Vice President, North America Commercial Operations at Beckman Coulter. Also on March 4, 2021, Dr. Mary Lake Polan informed the Board of Directors that she would not stand for reelection to the Board at the Company’s 2021 Annual Meeting of Shareholders.
Is New 90 Day High Low • Mar 05New 90-day low: US$4.36The company is down 33% from its price of US$6.46 on 04 December 2020. The American market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 1.0% over the same period.
お知らせ • Feb 26Chembio Diagnostics, Inc. to Report Q4, 2020 Results on Mar 11, 2021Chembio Diagnostics, Inc. announced that they will report Q4, 2020 results After-Market on Mar 11, 2021
Is New 90 Day High Low • Feb 05New 90-day high: US$7.58The company is up 60% from its price of US$4.74 on 06 November 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 8.0% over the same period.
分析記事 • Jan 16Is Chembio Diagnostics, Inc.'s (NASDAQ:CEMI) Shareholder Ownership Skewed Towards Insiders?If you want to know who really controls Chembio Diagnostics, Inc. ( NASDAQ:CEMI ), then you'll have to look at the...
お知らせ • Dec 19Chembio Diagnostics, Inc. Appoints David Acheson, M.D. to Its Board of DirectorsChembio Diagnostics, Inc. announced the appointment of David Acheson, M.D. to the Company’s Board of Directors. Dr. David Acheson has served as the President and Chief Executive Officer of The Acheson Group since founding the global food safety consulting group in 2013. Previously he served as a Partner and Managing Director of Leavitt Partners, where he founded and managed the firm’s food safety services business.
分析記事 • Dec 12Is Chembio Diagnostics (NASDAQ:CEMI) Weighed On By Its Debt Load?Warren Buffett famously said, 'Volatility is far from synonymous with risk.' It's only natural to consider a company's...
Price Target Changed • Dec 04Price target raised to US$9.00Up from US$6.00, the current price target is an average from 3 analysts. The new target price is 20% above the current share price of US$7.51. As of last close, the stock is up 88% over the past year.
お知らせ • Dec 03Chembio Diagnostics Wins $12.7 Million Contract by BARDA for Development of Rapid DPP Respiratory Antigen Panel and 510(k) Submission of the Rapid DPP SARS-CoV-2 Antigen Test SystemChembio Diagnostics, Inc. announced it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The contract will support the development and pursuit of U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system using Chembio’s proprietary DPP technology for the upcoming flu season. The contract also supports preparation of a submission in pursuit of FDA 510(k) clearance for the rapid DPP SARS-CoV-2 Antigen test system that was recently submitted to the FDA for an EUA. The award totals $12,691,726. A second portion of the contract will support the verification, process validation, and production of clinical validation data to be included in a submission to the FDA for 510(k) clearance and CLIA-waiver for the DPP SARS-CoV-2 Antigen test system. This system consists of a DPP SARS-CoV-2 Antigen test cartridge and a DPP Micro Reader analyzer and is designed to use a minimally invasive nasal swab to detect SARS-CoV-2 viral antigens in only 20 minutes. The system was developed by Chembio and submitted to the FDA for an EUA on October 15, 2020, with support from BARDA under contract number 75A50120C00138.
Is New 90 Day High Low • Dec 01New 90-day high: US$5.74The company is up 47% from its price of US$3.90 on 01 September 2020. The American market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.
Major Estimate Revision • Nov 12Analysts update estimatesThe 2020 consensus revenue estimate increased from US$21.1m to US$28.0m. Earning per share (EPS) estimate was further reduced from -US$1.17 to -US$1.24 for the same period. The Medical Equipment industry in the US is expected to see an average net income growth of 19% next year. The consensus price target of US$6.25 was unchanged from the last update. Share price is up 1.1% to US$4.48 over the past week.
Reported Earnings • Nov 08Third quarter 2020 earnings released: US$0.28 loss per shareThe company reported a soft third quarter result with increased losses and weaker control over expenses, although revenues were improved. Third quarter 2020 results: Revenue: US$10.3m (up 5.7% from 3Q 2019). Net loss: US$5.54m (loss widened 46% from 3Q 2019). Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 11% per year, which means it has not declined as severely as earnings.
Analyst Estimate Surprise Post Earnings • Nov 08Revenue and earnings beat expectationsRevenue exceeded analyst estimates by 162%. Earnings per share (EPS) also surpassed analyst estimates by 7.7%. Over the next year, revenue is forecast to grow 11%, compared to a 16% growth forecast for the Medical Equipment industry in the US.
お知らせ • Oct 16Chembio Diagnostics, Inc. Submits EUA Application for DPP SARS-CoV-2 Antigen Test SystemChembio Diagnostics, Inc. announced the submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2 Antigen test system, which has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyzer and a minimally-invasive nasal swab.
お知らせ • Oct 03Chembio Diagnostics, Inc Receives FDA Approval for DPP HIV-Syphilis SystemChembio Diagnostics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Premarket Approval (PMA) application for the DPP HIV-Syphilis System. The system includes the DPP HIV-Syphilis assay, a multiplex single-use test, and the DPP Micro Reader optical analyzer, and is being offered in the United States immediately. Co-infection rates of HIV and syphilis are on the rise and, according to the U.S. Centers for Disease Control and Prevention (CDC), individuals with an active syphilis infection have an estimated two-to-five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that untreated syphilis in pregnant women who acquired the disease during the four years before delivery can lead to infection of the fetus in up to 80% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis has increased by 185.3% from 2014 to 2018, consistent with the 165.4% increase in active syphilis infections among reproductive-aged women during the same period. Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing and treatment of infected pregnant women. Chembio’s DPP HIV-Syphilis System assists clinicians in diagnosing HIV or syphilis while patients are still at a POC setting. According to the U.S. Department of Health & Human Services, one in eight people living with HIV in the United States are unaware of their infection, and improving access to HIV testing can help more people learn their status so they can be connected to care and treatment. The CDC recommends that individuals at higher risk of HIV infection be tested at least annually.
お知らせ • Jul 24Chembio Diagnostics, Inc. to Report Q2, 2020 Results on Aug 06, 2020Chembio Diagnostics, Inc. announced that they will report Q2, 2020 results at 5:00 PM, Eastern Standard Time on Aug 06, 2020