|Over a week ago|
Chembio's Ethiopia order factored in estimates, says Benchmark » 14:1807/2207/22/21
After Chembio Diagnostics…
After Chembio Diagnostics announced the receipt of a $4M purchase order for HIV 1/2 STAT-PAK tests to be sent to Ethiopia, Benchmark analyst Bruce Jackson said the deal appears to be a continuation of a three-year contract granted in 2018. This was already assumed as part of his estimates for 2021 and 2022, which leaves him making no change to his estimates or Hold rating for Chembio, said Jackson.
Chembio Diagnostics announces $4M HIV test purchase order » 12:5207/2207/22/21
Chembio Diagnostics announced its receipt of a $4M purchase order from the Partnership for Supply Chain Management, or PFSCM, supported by The Global Fund, for the purchase of Chembio's HIV 1/2 STAT-PAK Assay for shipment to Ethiopia into early 2022. "Chembio's delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembio's supply chain, staffing, and liquidity, and other matters outside Chembio's control," the company said.
Colliers downgrades Chembio Diagnostics, says current price 'too aggressive' » 14:3507/2107/21/21
As previously reported,…
As previously reported, Colliers analyst Kyle Bauser downgraded Chembio Diagnostics to Neutral from Buy. He views the current share price as "too aggressive" given the company's below average growth rate, lack of near-term profitability and what he calls "disappointing execution over the past several quarters." Shares of Chembio Diagnostics are up $4.22, or 205%, to $6.28 in afternoon trading.
Chembio Diagnostics downgraded to Neutral from Buy at Colliers » 14:3207/2107/21/21
Colliers analyst Kyle…
Colliers analyst Kyle Bauser downgraded Chembio Diagnostics to Neutral from Buy.
Fly Intel: Pre-market Movers » 09:0207/2107/21/21
CEMI, JNJ, KO, VZ, ANTM, STX, IPG, HOG, SNBR, NFLX, STAF, MRNA, LUMO, CMG
Check out this morning's…
Chembio reports $28.3M purchase order for DPP SARS-CoV-2 antigen tests in Brazil » 07:5407/2107/21/21
Chembio Diagnostics announced its receipt of a $28.3M purchase order from Bio-Manguinhos for the purchase of Chembio's DPP SARS-CoV-2 Antigen tests for delivery during 2021 to support the urgent needs of Brazil's Ministry of Health in addressing the COVID-19 pandemic. "Chembio's delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembio's supply chain, staffing, and liquidity, and other matters outside Chembio's control. Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation, is responsible for the development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet demands of Brazil's national public health system. Chembio has a long-standing relationship with Bio-Manguinhos, having supplied multiple products for point-of-care detection of COVID-19 antibodies, HIV, and other infectious diseases. Bio-Manguinhos received regulatory approval from Agencia Nacional de Vigilancia Sanitaria in March 2021, following ANVISA approval of the test for Chembio's Brazilian subsidiary in November 2020," the company stated. In pre-market trading, Chembio Diagnostics shares have risen $2.17, or 105%, to $4.23.
Chembio Diagnostics announces at the market offering for up to $60M in stock » 07:2607/2007/20/21
In a regulatory filing,…
In a regulatory filing, Chembio Diagnostics announced that on July 19, 2021, the company entered into an at the market offering agreement, or the ATM agreement, with Craig-Hallum Capital Group, pursuant to which it may sell from time to time, at its option, up to an aggregate of $60M of shares of common stock through Craig-Hallum as sales agent. "We currently anticipate that the net proceeds from any sale of Shares under the ATM Agreement will be used for general corporate purposes, which may include, but are not limited to, working capital and capital expenditures. We cannot provide any assurances that we will issue any Shares pursuant to the ATM Agreement," the filing stated.
Chembio Diagnostics sees Q2 revenue $6.4M, consensus $8.53M » 07:2407/2007/20/21
In a regulatory filing…
In a regulatory filing last night, Chembio Diagnostics said: "We estimate that our total revenues for the three months ended June 30, 2021 were $6.4M. Our revenues during the three months ended June 30, 2021 did not meet our expectations, and the shortfall in our revenues has been a principal cause of our current limited cash and cash-equivalents position... In June 2021 the FDA notified us that it was again declining to review the DPP SARS-CoV-2 Antigen System based on the FDA's then-effective prioritization guidance, under which review of the test system was not a priority because of the anticipated resources needed by the FDA to continue review of our EUA request, the volume of EUA requests the FDA had received, and a variety of other factors, such as the public health need for the test system, the extent to which the test system would serve a significant unmet medical need, and the availability and adequacy of the information concerning the likelihood that the test system would be safe and effective in diagnosing the disease. Our clinical trials and the related timeline and achievement of related milestones under the Initial Grant had been delayed by factors including (a) the evolving U.S. populations with low COVID-19 positivity rates triggered by vaccination rollouts, (b) the impact of those evolving populations on the rate of enrolling subjects, and (c) the absence of guidance from the FDA regarding how to treat low positivity rates within a clinical study. The effects of the changing population were reflected in our clinical results and created complexities in the data set submitted for the FDA review in connection with the EUA application for the DPP SARS-CoV-2 Antigen System. In June 2021 BARDA extended the Initial Grant's contract period of performance at no additional cost to BARDA, in order to provide us the opportunity to submit a new EUA to the FDA to address the FDA's additional priorities and incorporate additional data collected from international populations with higher positivity rates. Subsequent to our EUA submission in May 2021, the FDA issued guidance permitting the inclusion in clinical data of foreign-sourced samples from regions with high COVID-19 positivity rates. We are in the process of collecting such samples in order to address the complexities in our data set that we believe resulted in the FDA's decision to deprioritize our second EUA application. We then intend to incorporate the collected samples in our clinical data for a new EUA application for the DPP SARS-CoV-2 Antigen System. There can be no assurance that the FDA will prioritize the review of our new EUA application if made or that, if the FDA does determine to review the new EUA application, the submitted materials will satisfy the performance criteria and other FDA review standards and requirements then being considered and applied by the FDA."
|Over a month ago|
Chembio Diagnostics reports Q1 EPS (22c), consensus (32c) » 17:2905/0605/06/21
Reports Q1 revenue…
Reports Q1 revenue $8.72M, consensus $8.19M. "In recent months we have advanced several strategic initiatives focused on leveraging the capabilities of our network of distributors and fully scaled U.S. salesforce across our diversified product portfolio," said Richard Eberly, Chembio's president and CEO. "Commercially, we are seeing good momentum with our SURE CHECK HIV Self-Test via our international channels and our DPP HIV-Syphilis system in the United States."
Chembio Diagnostics options imply 23.3% move in share price post-earnings » 15:1905/0605/06/21
Pre-earnings options volume in Chembio Diagnostics is normal with calls leading puts :. Implied volatility suggests the market is anticipating a move near 23.3%, or 81c, after results are released. Median move over the past eight quarters is 8.1%.