| Over a week ago | ||||
H.C. Wainwright analyst… H.C. Wainwright analyst Yi Chen lowered the firm's price target on Meridian Bioscience to $32 from $34 and reiterates a Buy rating on the shares after the FDA requested additional studies for Revogene Emergency Use Authorization resubmission. This temporary setback in EUA application and the commercial launch of Revogene SARS-CoV-2 molecular assay may delay the resumption of growth in the Diagnostics segment, Chen tells investors in a research note. | ||||
Meridian Bioscience… Meridian Bioscience updated its communication regarding the withdrawal of its application for Emergency Use Authorization, EUA, with the FDA for the SARS-CoV-2 molecular diagnostic test on its Revogene platform. In subsequent communication with the FDA mid-morning on February 23, the FDA clarified that Meridian will not be able to distribute its SARS-CoV-2 molecular diagnostic test on its Revogene platform until the test receives EUA approval from the FDA. This corrects the company's prior statement that the company would resume shipping the Revogene SARS-CoV-2 test to customers upon notification of its intent to re-submit an EUA application. | ||||
Piper Sandler analyst… Piper Sandler analyst Steven Mah maintains an Overweight rating on Meridian Bioscience with a $34 price target after the company elected to withdraw its Emergency Use Authorization application for its SARS-CoV-2 test on Revogene. Based on discussions with the FDA, Meridian intends to conduct a new clinical validation study from now to the end of March, including a limit-of-detection bridging study, Mah tells investors in a research note. The analyst had "conservatively" modeled $500,000 in COVID-19 revenue in the current quarter and $5M total for fiscal 2021. He expects to update his model post the fiscal Q2 earnings report. Mah expects COVID-19 testing will be "durable" through 2022. | ||||
Meridian Bioscience… Meridian Bioscience provided a further update on its application for Emergency Use Authorization, or EUA, with the U.S. Food and Drug Administration for the SARS-CoV-2 molecular diagnostic test on its Revogene platform. Following the submission of Meridian's written response to the FDA's request for additional information on its Revogene SARS-CoV-2 test on February 16, 2021 and further discussions with the FDA, on February 22, 2021, Meridian Bioscience elected to withdraw its EUA application. "Between now and the end of March 2021 and based on guidance from the FDA, Meridian intends to conduct a new clinical validation study and a Limit-of-Detection bridging study, with the intention of re-submitting an EUA application for its SARS-CoV-2 test on the Revogene platform as soon as possible thereafter. Upon notification to the FDA of its intent to re-submit an EUA application, during its third fiscal quarter, Meridian expects to resume shipping of this test to customers. Any change to our financial guidance will be discussed during our 2021 second fiscal quarter earnings call, scheduled for May 7, 2021, when we have more complete information," the company stated. | ||||
Meridian… Meridian Bioscience,provided an update on its application for Emergency Use Authorization with the U.S. Food and Drug Administration for the SARS-CoV-2 molecular diagnostic test on its Revogeneplatform. In its ongoing discussion with the FDA, late in the day on Friday, February 12, 2021, the Company received further correspondence requesting additional information on the SARS-CoV-2 molecular diagnostic test on its Revogene platform. Later today, the Company plans to submit a response with additional information to the FDA for its review. The Company has elected to place shipments of the SARS-CoV-2 test kits on hold while it continues to work with the FDA. | ||||
H.C. Wainwright analyst… H.C. Wainwright analyst Yi Chen raised the firm's price target on Meridian Bioscience to $34 from $30 and reiterates a Buy rating on the shares following the company's Q1 results. | |
Piper Sandler analyst… Piper Sandler analyst Steven Mah raised the firm's price target on Meridian Bioscience to $34 from $26 and reiterates an Overweight rating on the shares following the company's Q1 results. The analyst believes the guidance is "very conservative" given management's "pragmatic approach given the limited visibility on the durability of COVID-19 tailwinds." Mah has increased confidence in Meridian's longer-term COVID-19 tailwinds given the Biden Administration's testing stance, slower than expected vaccine rollout, and new strain emergence. | |
Sees revenue $320M-$350M,… Sees revenue $320M-$350M, consensus $307.42M. Sees Diagnostics segment $140M to $150M and Life Science segment $180M to $200M. FY2021 Adjusted Operating Margin: Consolidated 31% to 33%. | |
Reports Q1 revenue… Reports Q1 revenue $92.9M, consensus $83.89M. Jack Kenny, CEO, commented, "Q1 was another strong performance by the team and its great to have both Life Science and Diagnostics segments contributing to the pandemic. Submission of the Revogene SARS-CoV-2 assay EUA is the first key milestone in the resurgence of the Diagnostics segment during the remainder of the year." | |
Meridian Bioscience… Meridian Bioscience announced that it will increase production capacity of the company's SARS-CoV-2 molecular diagnostic test on its Revogene platform after receiving a $5.5M award from the National Institute of Health Rapid Acceleration of Diagnostics initiative and an additional grant from JobsOhio. "The funding will help Meridian expand production of Revogene test kits in the Quebec City facility and build a new semi-automated, state-of-the-art, two-line production facility near the corporate headquarters in the Village of Newtown. The expansion will be completed in phases over the coming months and is expected to yield a maximum capacity of 800,000 Revogene tests per month by the end of calendar year 2021," Meridian stated. |