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| Statement |
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| The studies confirmed the excellent performance of our test, the benefits of room tempera storage, the utility of the same test strip and method for samples of whole venous blood, capillary blood, and plasma, and the short turnaround time of the test 12 minutes |
| The expansion leverages our current installed instrument base, allowing for a strong operating margin on testing volumes within these new pharmacy sites during the upcoming respiratory season |
| So, it's quite a change in behavior and we think that bods really well for the future |
| Coming into this year's respiratory season, we believe we're well placed strategically to continue to grow the CRP business as a broader part of our respiratory portfolio |
| The innovative ultra-test strip design enables higher sample volumes enhancing detection levels and reaction times for more precise results |
| The clinical and operational benefits were studied across various patients, and the results were very positive |
| This reflects the overall benefit of the platform for tests being deployed in African countries where they have traditionally not been tested in the community |
| Partnerships like NHS from e-Health have demonstrated the test value in real-time decision-making for antibiotic treatment, resulting in improved patient safety experiences and cost savings |
| We do anticipate our significant capacity and low variable costs will enable seasonal revenues from the upcoming respiratory season to have a strong contribution margin to our gross margin and to our operating cash flows |
| So again, bringing together multiple assays on a single easy-to-use instrument with laboratory equivalent performance and a low cost of ownership is enabling a transformation in community-based care |
| Customer responses continue to be positive, supported by external clinical validations |
| Our CRP test has made significant strides, particularly in community-based settings like virtual wards in the UK |
| So, it's quite, it's a substantially quite significant change that we've had a positive change |
| In 50% of patients tested, the LumiraDx CRP test improved the safety of care and help to avoid the need for escalation to hospital care at a cost saving of up to 3,914 pounds per patient |
| Non-COVID platform test volumes excluding seasonal respiratory products increase 50% sequentially |
| This marks a significant milestone for LumiraDx as we work to expand the markets for our SARS-CoV-2 Ultra test |
| So, it showed the enormous benefit of actually being able to triage patients much earlier in the community and obviously therefore reduce the hospitalization or in the case of the person that went in, get the person in before they really deteriorate |
| A follow-up event was run in Manchester in July, which continues to show excellent results and a direct impact for individuals being immediately referred for further testing due to elevated results |
| Highlighting the positive impact of our menu expansion |
| Because they have their own products in congestive heart failure, they have tremendous advantage of catching people early based on their own products, not tests |
| This is an excellent example of how easy it can be to transform community-based healthcare with the LumiraDx platform when one single portal of instrument can have a major positive clinic or impact in nearly any setting |
| These tests also show utility in high-risk TB and HIV population |
| In the United States during Q2, we strategically positioned our North American business to take advantage of the upcoming respiratory season in the short-term, while also focusing on expanding our testing menu for both short-term and long-term growth |
| And troponin continues to move quite well |
| So, it really shows the power of our platform |
| Third, as reported in our recent press release, we're excited to report our submission of our five 10-K application to the FDA for the clearance of our five-minute COVID Ultra product |
| By offering the only fingertip NT-proBNP test at the point of care, we're able to gain access to key accounts for evaluation |
| We see that trend to, and will carry us through the rest of the year as the menu expansion really plays well in Europe and that will drive the non-respiratory growth |
| Outside of that, we continue to see the non-COVID portfolio grow |
| Our restructuring programs have reduced our operating expenses sequentially over the last five consecutive quarters since we exited the omni front wave and transitioned to endemic COVID |
| Statement |
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| Total adjusted gross margins for the quarter were a loss of $6.6 million |
| The decline in gross margin from Q1 was largely due to the new placement of more than 1,500 instruments in the U.S |
| Similar to Q1, the fixed cost base of our prior manufacturing investments pressure our overall margins at our current revenues |
| What we've seen with the warfarin patient population declining that business was in decline and it did require some significant investment to maintain the software |
| So, you made the comment that Q3 tends to be the weak in respiratory tends to be the weaker one, but actually, Q2 tends to often be the weaker one than Q3 because Q3 sometimes gets the initial stocking orders for the fourth quarter flu season, but obviously, because of the ITAP program, we don't know where we stand with the U.S |
| And of course, there's a lot of anxiety around because of the flu season |
| And so, we suspect that's the reason |
| So, yes, so the ITAP program continued to interact with us even though that in general, there's obviously a sharp reduction in U.S., but for this particular application still seems to be there |
| Because respiratory is such a big contributor, hard to guide with the uncertainty around timing |
| So obviously that high value, high margin respiratory product coming through in the end of the quarter could have a material impact on where we stand |
| Well the issue with Medtronic is that, they have a program into the community to try and screen out people with heart failure |
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