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Post by JHam on Jun 8, 2020 19:16:17 GMT
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Post by Yelk on Jun 9, 2020 10:06:19 GMT
Quotient Limited Provides Update on COVID-19 Antibody Test Progress, Other Key Developments and Fourth Quarter and Full Year Fiscal 2020 Results GlobeNewswire logo unavailable 06/09 10:00:10
Developed a high performance COVID-19 Antibody Test
Several customer contracts signed for MosaiQ system and COVID-19 Antibody Test Transfusion Dx Expanded Immunohematology (IH) Field Trials have restarted following COVID related delays Initial Serological Disease Screening (SDS) CE Mark obtained Continued Strong Top Line Growth in Fourth Quarter and Full Year JERSEY, Channel Islands, June 09, 2020 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (Quotient or the Company), headquartered in Eysins, Switzerland, today summarized recent key achievements. These included Quotient's rapid development of a high performance COVID-19 antibody test based on its innovative MosaiQ™ platform and several commercial MosaiQ contracts. Quotient's European Field Trials in transfusion diagnostics recently restarted for the Company's expanded MosaiQ IH microarray. A CE Mark was obtained for the Company's initial SDS microarray. The Company also announced strong top line growth for both its fourth quarter ended March 31, 2020 and for the full financial year.
“The global coronavirus crisis was a shock to everyone, but we are very proud of how the Quotient team leveraged the knowledge we acquired over the past eight years, and the flexibility of the MosaiQ platform, to develop a state of the art COVID-19 antibody test. The test performs with 100% sensitivity and 99.8% specificity and detects antibodies early due to its sensitivity to both IgM and IgG antibodies. The fact that we were able to sign several MosaiQ COVID-19 antibody test customer contracts, demonstrates the attractiveness of our innovative MosaiQ platform,” said Franz Walt, Chief Executive Officer of Quotient.
Mr. Walt added “I am pleased to report that we restarted the expanded IH Field Trials in Europe and we are expecting the first commercial transfusion menu in Q1 CY2021. I am also pleased that, despite the unprecedented disruption caused by the pandemic, we were able to exceed sales expectations for our Alba by Quotient reagent business.”
MosaiQ Platform
MosaiQ, Quotient's next-generation platform, is designed to deliver fast immunohematology, serological and molecular disease screening (MDS), using a single low volume sample on a high throughput automated platform. MosaiQ represents a transformative and highly disruptive unified testing system for transfusion diagnostics and beyond. Feasibility to deliver required performance in serological and molecular disease screening has been demonstrated. MosaiQ offers the potential to significantly reduce complexity and improve workflow for our customers.
Regulatory and Commercial Milestones
New Product Development – The rapid development of the Company's MosaiQ COVID-19 antibody test is a notable success. It also represents an interesting opportunity because the test is primarily commercialized outside of donor labs and therefore outside Quotient’s initial target market. It introduces the MosaiQ platform to a different market. The first customer contract was signed shortly after the CE marking and the Company subsequently entered into several more contracts with customers in Europe and the United States. European Regulatory Approval – The CE mark for the initial MosaiQ IH microarray was obtained in April 2019 and for the initial SDS microarray in February 2020. The COVID-19 antibody test was CE marked on May 1, 2020 and is the fifth CE mark for the MosaiQ platform US Regulatory approval – Quotient submitted a 510(K) for the initial SDS microarray and the MosaiQ device in December 2019. The request for FDA Emergency Use Authorization of the COVID-19 antibody test was submitted on May 6, 2020 Field Trials – Expanded IH field trials in Europe restarted recently after they were interrupted in March due to the coronavirus pandemic Ongoing Microarray Menu Development – Two benchmark studies were successfully completed for selected SDS and MDS parameters demonstrating the high performance of the MosaiQ technology Upcoming Regulatory Submissions– Submission of the expanded IH microarray in Europe is expected in Q4 of CY2020 followed by US submission in the first half of CY2021. The European submission of the expanded SDS microarray is expected in the second half of CY2021 Franz Walt commented “I am delighted with the Quotient team who were able to turn the crisis into a positive contribution to the fight against COVID-19 and who continue to deliver on our goals.”
Fiscal Fourth Quarter and Full Year Financial Results
The Alba by Quotient reagent business once again generated strong revenue growth during fiscal 2020, with product revenues growing 10.2% for the full year and 11.1% in the fourth quarter. Product revenue growth for the fiscal year was driven by 5% growth in sales to original equipment manufacturer (OEM) customers, while direct product sales grew 24%. In the fourth quarter, gross margin on product sales was 45.6% compared to 43.5% in the fourth quarter of fiscal 2019, reflecting improved product mix and the efficiencies gained through the Company’s new reagent manufacturing site. For fiscal year 2020 gross margin on product sales also improved year on year from 39.9% to 43.7%, as the incremental costs of the relocation to the new manufacturing site were removed. Milestone payments earned from the development and approval for sale in the United States of certain rare antisera reagents developed for a key OEM customer, contributed $1.1 million of other revenues in fiscal year 2020 compared to $0.5 million in the prior year.
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Post by Yelk on Jun 9, 2020 10:07:00 GMT
I like the PR, its not pumpy just solid, will maybe give more realistic growth. I somehow don't feel like will be much move in the stock today though.
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Post by magnus123 on Jun 9, 2020 10:20:57 GMT
The first customer contract was signed shortly after the CE marking and the Company subsequently entered into several more contracts with customers in Europe and the United States.
I like this:)
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Post by JHam on Jun 9, 2020 10:25:26 GMT
The first customer contract was signed shortly after the CE marking and the Company subsequently entered into several more contracts with customers in Europe and the United States.I like this:)
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Post by JHam on Jun 9, 2020 10:33:57 GMT
The first customer contract was signed shortly after the CE marking and the Company subsequently entered into several more contracts with customers in Europe and the United States.I like this:) Sorry Magnus, don't mean to keep stealing your thunder over at ST
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Post by magnus123 on Jun 9, 2020 11:03:04 GMT
The first customer contract was signed shortly after the CE marking and the Company subsequently entered into several more contracts with customers in Europe and the United States.I like this:) Sorry Magnus, don't mean to keep stealing your thunder over at ST No problem, JHam I hope for some details about the additional contracts in the CC, especially regarding US.
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Post by JHam on Jun 9, 2020 13:47:26 GMT
My quick summary of the call in terms of COVID only:
• Machines are selling like hotcakes • Only 3 left • Finalizing the contracts for remaining machines as we speak • Can’t disclose costs per customer, but emphasized that since MosaiQ is highest quality, it is not cheap • Don’t need and FDA approval to use in USA • Customers could ask for refund if rejected by FDA, but don’t anticipate that since customers read data and are happy with performance
Q2 results later in the year should be great!
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Post by magnus123 on Jun 9, 2020 14:09:19 GMT
My quick summary of the call in terms of COVID only: • Machines are selling like hotcakes • Only 3 left • Finalizing the contracts for remaining machines as we speak • Can’t disclose costs per customer, but emphasized that since MosaiQ is highest quality, it is not cheap • Don’t need and FDA approval to use in USA • Customers could ask for refund if rejected by FDA, but don’t anticipate that since customers read data and are happy with performance Q2 results later in the year should be great! Very nice CC. I pressed the button this morning one last time. I must be crazy!
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Post by JHam on Jun 9, 2020 14:38:53 GMT
My quick summary of the call in terms of COVID only: • Machines are selling like hotcakes • Only 3 left • Finalizing the contracts for remaining machines as we speak • Can’t disclose costs per customer, but emphasized that since MosaiQ is highest quality, it is not cheap • Don’t need and FDA approval to use in USA • Customers could ask for refund if rejected by FDA, but don’t anticipate that since customers read data and are happy with performance Q2 results later in the year should be great! Very nice CC. I pressed the button this morning one last time. I must be crazy! Nice! Hope this keeps moving up through FDA approval.
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Post by JHam on Jun 9, 2020 17:38:43 GMT
I don’t want to jinx it, but I am hoping that this upswing today is due to increased revenue, which is not even considering forward revenues from COVID. If that’s the case maybe we’ll form a new base in the $8s.
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Post by JHam on Jun 9, 2020 17:40:23 GMT
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Post by selluwud on Jun 9, 2020 18:36:47 GMT
That was posted 2 hours ago, was it in their press release?? I hope it supports the momentum here leading to FDA approval PR??
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Post by selluwud on Jun 12, 2020 17:49:40 GMT
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Post by JHam on Jun 12, 2020 18:13:42 GMT
That was posted 2 hours ago, was it in their press release?? I hope it supports the momentum here leading to FDA approval PR?? Yes it was.
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Post by magnus123 on Jun 23, 2020 22:16:43 GMT
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Post by JHam on Jun 24, 2020 0:04:11 GMT
Awesome thanks! I imagine we’ll hear from the company first about EUA approval before we see the list updated.
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Post by JHam on Jun 24, 2020 0:09:14 GMT
Franz speaks great German! I hope they are saying that once they prove the test works for COVID-19 that Roche will buy them out for $10B...
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Post by magnus123 on Jun 24, 2020 6:51:13 GMT
Awesome thanks! I imagine we’ll hear from the company first about EUA approval before we see the list updated. I expect that too. The FDA updates the list always with one or two days delay.
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Post by magnus123 on Jun 24, 2020 6:55:27 GMT
Franz speaks great German! I hope they are saying that once they prove the test works for COVID-19 that Roche will buy them out for $10B... The EUA would be the prove, as the FDA looks very deep into the data etc. The funny thing is that also this TV news published does not highlight the key advantages of Mosaiq that makes it a better test than Roches. For them, the Roche Test is the best for some reason. Roche has a lot of influence on the public media. Same for the german media. They praised the Roche test like priests.
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