Q4 2021 ENDRA Life Sciences Inc Earnings Call
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Good day, and welcome to the Endrow Life Sciences Fourth Quarter 2021 Financial Results Conference Call. All participants will be in listen-only mode.
Good day and welcome to the NGL Lifesciences fourth quarter 2021 financial results Conference call.
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I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
Thank you operator this is Yvonne Briggs without like Jay Good afternoon, and welcome to <unk> fourth quarter, 2021 business update and financial results Conference call.
Yvonne Briggs: Thank you Operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to ENDRA's fourth quarter 2021 Business Update and Financial Results Conference Call. Earlier today ENDRA issued a press release on this topic which is available in the Investors section of ENDRA's website.
Earlier today and dry issued a press release on this topic, which is available in the investors section of <unk> website.
Yvonne Briggs: Before we begin, please note that today's discussion will include forward-looking statements.
Before we begin please note that today's discussion will include forward looking statements.
Yvonne Briggs: All statements by management, other than statements of historical facts, including statements regarding the company's strategies, financial condition, operations, costs, plans, and objectives, as well as anticipated results of development and commercialization efforts, the timing of clinical studies, and the timing of clinical research.
All statements by management other than statements of historical facts, including statements regarding the company strategies financial condition operations costs plans and objectives as well as anticipated results of development and commercialization efforts the timing of clinical studies potential partner.
Yvonne Briggs: Potential partnership opportunities and expectations regarding regulatory processes, receipt of required regulatory clearances and product launches are for looking statements.
Ship opportunities and expectations regarding regulatory processes receipt of required regulatory clearances and product launches are forward looking statements except.
Yvonne Briggs: except as otherwise required by federal securities laws, the company disclaims any obligation to update or revise any forward-looking statements.
Except as otherwise required by federal Securities laws, the company disclaims any obligation to update or revise any forward looking statements.
Yvonne Briggs: Please refer to the company's 2021 Form 10K file later today in subsequent SEC filings for more information about risks and uncertainties related to forward-looking statements.
Please refer to the company's 2021 Form 10-K filed later today and subsequent SEC filings for more information about risks and uncertainties related to forward looking statements.
In terms of the structure of today's call Francois Mitchell, one chairman and Chief Executive Officer will begin the prepared remarks, followed by Renault Mallow, Bertie Andrews, Chief Commercial Officer, and Arena Petra Carver Senior director of Finance with that said I will now turn the call over.
Yvonne Briggs: In terms of the structure of today's call, Francois Michelin, Chairman and Chief Executive Officer will begin the prepared remarks, followed by Renault Maliburti, Andrews Chief Commercial Officer, and Irina Pestrikova, Senior Director of Finance.
Yvonne Briggs: With that said, I will now turn the call over to Francois Michelin Francois.
To Francois Michelle on Francois.
Francois Michelon: Thank you, Yvonne. Good afternoon, everyone. And thanks for joining us today for a discussion of Endress 2021 Fourth Quarter in full-year financial results and an update on our business.
Thank you Ivan and good afternoon, everyone and thanks for joining us today for a discussion of <unk> 2021 fourth quarter and full year financial results and an update on our business.
Francois Michelon: The last few months have been a productive time for UNDRA with several noteworthy accomplishments, including first, clarifying the U.S. regulatory strategy for our TEA system to a de novo pathway, a strategy that is supported by the FDA.
The last few months have been a productive time for Andre with several noteworthy accomplishments, including first clarifying the U S regulatory strategy for our <unk> system to a de novo pathway.
Strategy that is supported by the FDA.
Second securing new clinical research partners in China, and the U K, which will expand the sources of data supporting our global commercialization efforts.
Francois Michelon: Second, securing new clinical research partners in China and the UK, which will expand the sources of data supporting our global commercialization efforts.
Francois Michelon: Third, signing a second pharmaceutical partnership to expand the adoption of TAIS beyond the clinical end-user market.
Third signing a second pharmaceutical partnership to expand the adoption of <unk> beyond the clinical end user market.
Fourth ramping up our commercial efforts in Europe as pandemic restrictions are lifted in key geographies.
Francois Michelon: Fourth, ramping up our commercial efforts in Europe as pandemic restrictions are lifted in key geographies.
Francois Michelon: Fifth, strengthening our intellectual property portfolio to protect our technology and enhance our out licensing opportunities.
Fifth strengthening our intellectual property portfolio to protect our technology and enhance our out licensing opportunities.
Francois Michelon: and six, maintaining a capital efficient business model with a solid balance sheet in order to support our operating plan in 2022.
And six maintaining our capital efficient business model with a solid balance sheet in order to support our operating plan in 2022.
I'll start with an update on our U S regulatory strategy.
Last month, we announced that after extensive and productive dialogue with the FDA. Andrew is now pursuing a de novo request, where our tastes liver system.
Francois Michelon: Last month, we announced that after extensive and productive dialogue with the FDA, Andrew is now pursuing a de novo request for Arteas Liberty.
The de Novo process builds on our completed five 10-K submission and provides us with the opportunity to set the bar for an entirely new product classification, which can yield important and sustainable commercial advantages for the tastes platform once approved.
Francois Michelon: the DeNovo process builds on our completed 510K submission and provides us with the opportunity to set the bar for an entirely new product class.
Francois Michelon: which can yield important and sustainable commercial advantages for the TEAAS platform once approved.
We will be able to leverage a substantial portion of our five 10-K submission which encompasses many of the same elements needed for the de novo request, including safety and efficacy data.
Francois Michelon: We'll be able to leverage a substantial portion of our 510K submission, which encompasses many of the same elements needed for the de novo request, including safety and efficacy.
Francois Michelon: We believe we're aligned with the FDA on the scope of the clinical data they require and we intend to include data from a subset of our global clinical.
We believe we are aligned with the FDA on the scope of the clinical data they require and we intend to include data from a subset of our global clinical partnerships.
Francois Michelon: committed to generating this additional data as quickly as possible and to submitting the de novo in the coming month.
We're committed to generating this additional data as quickly as possible and to submitting the de novo in the coming months.
Francois Michelon: Finally, since the FDA is familiar with key elements of our 510K submission, we're optimistic that the noble process will be efficient.
Finally, since the FDA is familiar with key elements of our five 10-K submission we're optimistic but it's novo process will be efficient.
Francois Michelon: As a reminder, we previously secured CE mark approval, which serves as an important precedent for additional regulatory approvals throughout the world, and more importantly, means we can actively market the TEA system in Europe , which is our current commercial
As a reminder, we previously secured CE Mark approval, which serves as an important precedent for additional regulatory approvals around the world and more importantly, it means we can actively market the tier system in Europe , which is our current commercial focus.
I'm happy to announce that earlier today, we received the ISO $13 45 to a one six recertification from the British standards institution, which validates the foundation and sustainability of our quality management system upon which we obtained our CE marking.
Francois Michelon: I'm happy to announce that earlier today, we received the ISO 13485-2016 re-certification from the British Standards Institution, which validates the foundation and sustainability of a quality management system, upon which we obtain or see
Francois Michelon: In addition, I want to note that the FDA has proposed adoption of these ISO standards in an effort to harmonize its quality system regulation with the international standard. So, Andra is ahead of the game here.
In addition, I want to note that the FDA has proposed adoption of these ISO standards and an effort to harmonize its quality system regulation with the international standards. So Andrew is ahead of the game here.
Francois Michelon: In terms of commercial activity, the COVID-19 recovery is on a positive trend globally from a mortality perspective. However, the pandemic continues to impact individual countries at different levels.
In terms of commercial activity.
COVID-19 recoveries on a positive trend globally from a mortality perspective, however, the pandemic continues to impact individual countries at different levels.
Francois Michelon: As such, Endra's sales team is driving awareness for our TEA system in person and virtually as allowed in each geography. For example, in Germany, which still restricts in-person sales visits to hospitals, we're conducting virtual sales.
Such Andrew sales team is driving awareness for our tier system in person and virtually as allowed in each geography for example, in Germany, which still restricts in person sales visits to hospitals, we're conducting virtual sales calls.
Francois Michelon: In France and the UK, I'm encouraged that we're now conducting a growing number of in-person sales calls and demonstrating our technology in-person at clinical conferences in hepatology and increasingly endocrinology. Renaud will go in-depth into our commercial activities in a moment.
In France, and the UK I'm encouraged that we're now conducting a growing number of in person sales calls and demonstrating our technology in person at clinical conferences in herpetology and increasingly endocrinology.
We will go in depth into our commercial activities in a moment.
Let's turn to our clinical research activity.
We've grown our clinical research partnerships eight globally three in the U S.
Francois Michelon: We've grown our clinical research partnerships to eight globally, three in the US, four in Europe ,
Four in Europe , and one in Asia and.
Francois Michelon: In December , we added the prestigious King's College Hospital in London, a teaching hospital that's world-renowned for its pining research in liver disease.
In December we added the prestigious King's College Hospital in London, a teaching hospital that is world renowned for its painting research and liver disease.
Last month, we expanded into China with our new clinical research partner, Shanghai General Hospital, which has the highest ranking in China's classification system of a plus plus by China's National Health Commission.
Francois Michelon: Last month, we expanded into China with our new clinical research partner, Shanghai General Hospital, which has the highest ranking in China's classification system of A++ by China's National Health Committee.
Francois Michelon: This rating is awarded to only 12 of China's approximately 35,000 healthcare
This rating is awarded to only 12 of China's approximate 35000 health care facilities. We believe this is one of the strongest partners possible to provide an entry point strategically into the Chinese healthcare market to help address an estimated 350 million people in China affected by National and Nash.
Francois Michelon: We believe this is one of the strongest partners possible to provide an entry point strategically into the Chinese healthcare market to help address an estimated 350 million people in China affected by Nassau and Nassau.
Francois Michelon: Collecting TEA's clinical data from our eight global partners is the primary focus for ENDRA in 2022. This local data from sites in France, the UK, Germany, Switzerland will be key to driving commercial adoption of TEA's in each market, providing independent local evidence of how TEA's performs compared to the gold standard of MRI.
Collecting tastes clinical data from our eight global partners is the primary focus for Android in 2022. This local data from sites in France, The U K, Germany, Switzerland will be key to driving commercial adoption of <unk> in each market, providing independent local evidence of how Te is performs.
Compared to the gold standard of MRI.
Francois Michelon: We've had a good start to the year with data collection underway at two clinical sites in the U.S. and expect a third site to initiate recruitment of study participants in the next few weeks.
We've had a good start to the year with data collection underway at two clinical sites in the U S and expect a third site to initiate recruitment of study participants in the next few weeks.
Each of these sites will be comparing liver fat assessments in patients scanned with the Tia system with the same patients scanned with MRI with.
Francois Michelon: Each of these sites will be comparing liver fat assessments in patients scanned with a TAEA system with the same patients scanned with MRI.
Francois Michelon: with both scans performed with a couple of weeks of one another to ensure comparability
With both scans performed with a couple of weeks of one another to ensure comparability of results.
Francois Michelon: As we noted on previous calls, many of the world's clinical research activities were paused for last year or two due to COVID. So our progress has been slow to
As we noted on previous calls many of the world's clinical research activities, we'll pause for last year or two due to COVID-19 . So our progress has been slowed a bit.
Francois Michelon: While we continue to see some backlog of MRI systems of hospitals where postponed elective procedures have returned in high volume, overall healthcare access and operations are looking stronger in 2022, which is an encouraging recent development.
While we continue to see some backlog of MRI systems at hospitals were postponed elective procedures are returned and high volume overall health care access and operations are looking stronger in 2022, which is an encouraging recent development.
Francois Michelon: Internationally, we remain committed to getting our European research sites in the UK, France, Germany, and Switzerland up and running in the coming months, and all told, we anticipate scanning 2 to 300 patients globally by the end of 2020.
Internationally, we remain committed to getting our European research sites in the U K, France, Germany, and Switzerland up and running in the coming months and all told we anticipate scanning two to 300 patients globally by the end of 2022.
Francois Michelon: I'll point out that TAYS clinical studies don't need to be completed and published to support our sales team. The research sites just need to be active so our sales team can connect potential buyers to speak with the study investigators and discuss how TAYS is performing relative to MRI.
I'll point out that tastes clinical studies don't need to be completed and published to support our sales team. The research sites just need to be active so our sales team can connect potential buyers to speak with our study investigators and discuss how <unk> is performing relative to MRI.
Francois Michelon: Turning now to Andrew's commercial opportunities beyond frontline clinicians in hepatology, radiology, and endocrinology, we believe our technology holds considerable potential value to pharmaceutical companies and contract research organizations that are conducting clinical studies and need an efficient and practical way to measure liver fat as a metabolic biomarker.
Turning now to Andrew as commercial opportunities beyond frontline clinicians in herpetology radiology and endocrinology, we believe our technology holds considerable potential value to pharmaceutical companies and contract research organizations that are conducting clinical studies and need an efficient and practical way to <unk>.
Your liver fat as a metabolic biomarker.
Francois Michelon: By our count, there are over 50 companies working in this area, and each company has up to several hundred research sites associated with their drug
By our count there are over 50 companies working in this area and each company has up to several hundred research sites associated with their drug trials.
In November we signed a collaboration agreement with V. Gi health technologies to pilot tests as an add on technology to support their patient screening and biomarker measurement during their upcoming phase two national Nash study.
Francois Michelon: In November , we signed a collaboration agreement with VGI Health Technologies to pilot PAYUS as an add-on technology to support their patient screening and biomarker measurement during their upcoming phase 2 NASL NASH.
This follows our first pharmaceutical collaborative agreement with happy on Pharmaceuticals to incorporate our <unk> technology into their phase <unk> study for the treatment of Nash.
Francois Michelon: This follows our first pharmaceutical collaborative agreement with Hepeon Pharmaceuticals to incorporate Arctaeus technology into their phase 2B study for the treatment of NASH.
We believe tastes can help drive time and cost savings for companies developing liver and metabolic disease drugs, starting with the clinical trial enrollment process, which currently rejects in the industry on average over 50% of potential recruits after incurring the high cost and inconvenience of an MRI or biopsy.
Francois Michelon: We believe TAIS can help drive time and cost savings for companies developing liver and metabolic disease drugs, starting with a clinical trial enrollment process, which currently rejects, in the industry on average, over 50% of potential recruits after incurring the high cost and inconvenience of an MRI or biopsy.
Francois Michelon: Ender's technology may have an important role up front in screening patients to determine if they meet the study's criteria before they're sent to an MRI or bio.
Andrew Technology May have an important role upfront in screening patients to determine if they meet the study's criteria before they're sent to an MRI or biopsy.
Francois Michelon: This belief is substantiated by the two existing pharma partnerships we've secured, as well as other active discussions underway.
This belief is substantiated by the two existing pharma partnerships and secure as well as other active discussions underway.
Francois Michelon: Turning now to our intellectual property, continue to grow our portfolio to protect our technology globally for multiple indications, as well as positioning Andra for out-licensing.
Turning now to our intellectual property continue to grow our portfolio to protect our technology globally for multiple indications as well as positioning Andrea for out licensing opportunities in.
Francois Michelon: In the fourth quarter of 2021, four domestic patents were issued for a total of 24 patents in the U.S. To date, in 2022, one patent has been issued in the U.S., two patents have been issued in Europe , and two were issued in China.
In the fourth quarter of 2021 for domestic paths were issued for a total of 24 patents in the U S to date in 2022, one patent has been issued in the U S. Two patents have been issued in Europe , and two were issued in China.
Francois Michelon: our current global IP portfolio stands at 89 assets, which we define as patents in preparation, file, or issue.
Our current global IP portfolio stands at 89 assets, which we define as patents in preparation filed or issued.
With that update I'd like to turn the call over to Renaud mellow Verde to provide more detail on our commercial activities Renault.
Francois Michelon: With that update, I'd like to turn the call over to Renault Malabarity to provide more detail on our commercial activities. Renault?
Thank you for swap and good afternoon, everyone. Our European sales team continues to drive awareness of the <unk> system and to enhance our commercial efforts in region, where COVID-19 restrictions are easing.
Reno Malliabity: Our European sales team continues to drive awareness to the tiered system and to enhance our commercial efforts in region where COVID restrictions are eased.
Reno Malliabity: Currently, we have four commercial representatives in the UK, France, and Germany. As sales and marketing activities pick up, we intend to add personnel in high-value markets while diligently managing our cost structure.
Currently we have four commercial represented even in the UK, France and Germany.
Sales and marketing activities pick up we intend to add personnel in high value markets, while diligently managing our cost structure.
In certain countries, including Germany, Austria, the Netherlands, and Norway outreach efforts.
Reno Malliabity: In certain countries, including Germany, Austria, the Netherlands, and Norway, outreach efforts are currently still limited to video conference meetings, while in other with lower COVID case levels like France and UK, we are able to execute a higher degree of in-person visits and group demonstrations.
Our Kurt you still limited to video conference meetings, while in other with lower Covid case level like for instance, you gate, we are able to execute a higher degree of in person visits and group demonstrations.
Reno Malliabity: We are confident that the TAYUS value proposition to assess liver fat will begin to gain traction in the marketplace as we expand our commercial efforts with more and more product demonstrations.
We are confident that the <unk> value proposition to assess liver fat will begin to gain traction in the marketplace as we expand our commercial efforts with more and more product demonstrations.
On average we expect the sales cycle for <unk> to be several months from the time of <unk>.
Reno Malliabity: On average, we expect the sales cycle for Tejas to be several months from the time of the first in-person customer interaction, given its novel technology as a capital equipment purchase, although we expect that this will vary widely by customer and by institution.
The first in person customer interaction given its novel technology is a capital equipment purchase although we expect that this will vary widely by customer and by institutions.
Reno Malliabity: We also understand that generating TAIS and MRI clinical data from our clinical research partners in each target market is essential to converting demonstrations to sales.
We also understand that generating tiers and MRI clinical data from our clinical research partners in each target market is essential to converting demonstrations to sales.
Reno Malliabity: Our long-standing partner GE Healthcare is providing valuable assistance to supplement our direct sales effort as GE has a significant install base of ultrasound clients. We continue to coordinate sales activities, to leverage resources, and to collaborate on positioning in the marketplace given GE's dominant global market presence in imaging diagnostics.
Our longstanding partner GE healthcare is providing valuable assistance to supplement our direct sales efforts as GE as a significant installed base of ultra's on clients. We continue to coordinate sales activities to leverage resources and to collaborate on positioning in the marketplace given your dominant glue.
<unk> market presence in imaging diagnostics.
In addition to clinician outreach by our salespeople in each market, we are pursuing a range of marketing initiatives.
Reno Malliabity: In addition to clinician outreach by our salespeople in each market, we are pursuing a range of marketing initiatives to create awareness and build interest in the TIS system. These include various e-marketing activities, educational video campaigns, white papers, use of social media, and leveraging our website as a resource for information and data on the benefit of TIS.
To create awareness and build interest into tier system.
These include various E marketing activities educational video campaigns White papers use of social media and leveraging our website as a resource for information and data on the benefit of tastes.
Last week Hendra, either booth at the French Society of Diablo Ledger Conference, which was focused on advanced technologies and treatment for diabetes. This clinical meeting of trucks 4500, clinicians focused on diabetes and metabolic health.
Reno Malliabity: Last week, Hendra had a booth at the French Society of Diabetology Conference, which was focused on advanced technologies and treatment for diabetes.
Reno Malliabity: This clinical meeting attracts 4,500 clinicians focused on diabetes and metabolic health.
Reno Malliabity: We posted images on our well-attended booth of our well-attended booth and sales team demonstrating TAS on social media.
We posted images on our a well attended two of our wells ended within sales team demonstrating pays on social media.
Reno Malliabity: Attending the Diabetes Conference is part of our dual strategy to further penetrate individual markets like France and to grow outside of radiology and hepatology. We plan to show our technology at over 10 global clinical conferences this year, which is a 40% increase over the seven conferences we attended last.
Attending a diabetes conference is part of our dual strategy to further penetrate individual markets like France and to grow outside of radiology and hepatology.
We plan to show our technology at over 10 global clinical conferences, this year, which a 40% increase over the seven conferences, we attended last year.
Reno Malliabity: through our commercial fieldwork last year, it has become clear that another clinical sales opportunity exists.
Through our commercial field work last year. It has become clear that another clinical sales opportunity exists targeting endocrinologists, we're seeking practical diagnostic tools to assess liver fat and identify patients with Nf L. D.
Reno Malliabity: targeting endocrinologists who are seeking practical diagnostic tools to assess liver fat and identify patients with NASLD.
Which occurs in 80% to 90% of obese adults, adding 30% to 50% of patients with type two diabetes.
Reno Malliabity: which occurs in 80 to 90% of obese adults and in 30 to 50% of patients with type 2 diabetes. You see, many patients with AFLD are asymptomatic and go undiagnosed for years as their liberal health deteriorates. In fact, an estimated 25% of NASH patients
Many patients with Nf L. D are asymptomatic and go undiagnosed for years as their liver health deteriorates in fact, an estimated 25% of my speech Nash patients develop fibrosis, which can result in permanent scarring and liver failure as such it is imperative for the <unk>.
Reno Malliabity: develop fibrosis, which can result in permanent scarring and liver failure. As such, it is imperative for the endocrinologist to have a non-invasive diagnostic tool at the point of care, like the tier system, to a system in identifying...
Just to have a non invasive diagnostic tool at the point of care liked it to assist them to assist them in identifying.
Reno Malliabity: and risk stratifying patients in the early stages of NAFLD, and to continue with monitoring and assessing liver health after the accident.
And risks try to find patients in the early stages of Nf L D and to continue with monitoring and assessing liver health after diagnosis.
Reno Malliabity: By adding endocrinology as a sales call point, it expands our addressable market beyond hepatology and radiology and builds on what we are learning during the initial launch phase of TAS. In response to market dynamics, EnBRA is also developing TAS rental options to facilitate customers adoption if their capital budgets are limited and or time-consuming to access.
By adding endocrinology as a sales call point it expands our addressable market John Herpetology in radiology and build on what we are learning during the initial launch phase of tests in response to market dynamics and <unk> is also developing tests rental options too.
<unk> customers adoption.
<unk> capital budget are limited and or time consuming to access the benefit of this additional sales approach is the potential to generate recurring revenue for and draw. In addition to service agreements on the tier system versus a one time sales for a standalone unit in summary, despite some room.
Reno Malliabity: The benefit of this additional sales approach is the potential to generate recurring revenue for Andra in addition to service agreements on the DEA system versus a one-time sale for a standalone unit.
Reno Malliabity: In summary, despite some remaining COVID headwinds, we have a well-trained and active sales team. On the ground, we are expanding our outreach to new high-value clinical segment, including endocrinology. We are increasing our presence at clinical conferences by 40% this year, and we are developing new customer purchase options, all of which we are confident will yield revenue for ENDROP.
Meaning COVID-19 headwinds, we have a well trained and active sales team on the ground. We are expanding our outreach to new high value clinical segment, including endocrinology, we're increasing our presence at clinical conferences by 40%. This year and we are developing new customer purchase options.
All of which we're confident will yield revenue for and drop.
Speaker Change: Now I'd like to turn the call over to Irina to review our recent financial results. Irina?
Now I'd like to turn the call over to Irina to review, our recent financial results Irina.
Arena Pestroova: Our financial results for the fourth quarter and through year 2021 are as follows.
Thank you right now.
Financial results for the fourth quarter and full year 2021, Alright, followed.
Arena Pestroova: For the quarter ended December 31, 2021, our operating expenses increased to $3.1 million from $2.3 million for the same period in 2020. The increase was primarily due to higher headcount and regulatory expense.
For the quarter ended December 31, 2021 our operating expenses increased to $3 $1 million from $2 $3 million for the same period in 2020.
The increase was primarily due to higher head count and regulatory expense.
Arena Pestroova: Our net loss for the fourth quarter and the December 31, 2021 was $3.1 million or $0.07 per share, as compared with a net loss of $2.3 million or $0.08 per share a year ago.
Our net loss for the fourth quarter ended December 31, 2021 was $3 1 million or seven cents per share as compared with a net loss of $2 $3 million or eight cents per share a year ago.
Overall for the year ended December 31, 2021, our operating expenses were $11 $5 million.
Arena Pestroova: Overall, for the year ended December 31, 2021, our operating expenses were $11.5 million unchanged from 2020. Increases in sales and marketing expenses were offset by decreases in research and development and general administrative
Changed from 2020.
Increases in sales and marketing expenses were offset by decreases in research and development and general and administrative expense.
Our research and development expense decreased year over year by approximately $435000 due to reduced spending for product development.
Arena Pestroova: our research and development expense decreased year-over-year by approximately $435,000 due to reduced spending for product development.
Our sales and marketing expense increased by approximately $493000 for the year as we began to expand our sales efforts, including adding to our head counts.
Arena Pestroova: our sales and marketing expense increased by approximately $493,000 for the year as we began to expand our sales efforts, including adding to our headcount.
Arena Pestroova: general administrative expenses, decreasing by approximately $62,000, future reduced spending for investor relations and legal fees.
General administrative expenses decreased by approximately $62000 due to reduced spending for investor relations and legal.
Our net loss for 2021 was $11 $2 million or 28 cents per share as compared with a net loss of $11 $7 million or 63 cents per share in 2020.
Arena Pestroova: Our net loss for 2021 was $11.2 million or $0.28 per share as compared with the net loss of $11.7 million for 63 cents per share in 2020.
Arena Pestroova: We continue to maintain an asset-wide operating model with a conservative cost structure as we advance our commercialization initiative.
We continue to maintain an asset light operating model with a conservative cost structure as we advance our commercialization initiatives.
Arena Pestroova: As of December 31, 2021, we had cash and cash equivalence of $9.5 million and continue to have availability from our at-the-market offering program, which we'll utilize on an opportunistic basis.
As of December 31, 2021 we had cash and cash equivalents of $9 $5 million and continued to have availability from our at the market offering program, which will utilize an opportunistic basis.
Arena Pestroova: With a liberal well-capitalized with a solid balance sheet to support our commercial activities through 2022 in Europe , as we prepare our genover request for the FDA. Now,
Well the label are well capitalized with a solid balance sheet disappoint, our commercial activities through 2022 in Europe as we prepare our de Novo request for the M D.
Now I'll turn the call back different though.
Speaker Change: Thanks very much, Renault and Irina. As we look to the balance of 2022, we're focused on achieving several significant milestones. And these include, first, advancing TAS through the US regulatory process and submitting a de novo request.
Thanks, very much Renaud and arena.
As we look to the balance of 2022, we're focused on achieving several significant milestones and these include first advancing tests through the U S regulatory process and submitting a de novo request.
Speaker Change: Second, demonstrating TASA's clinical value by generating additional data with our strategically positioned research sites to support our regulatory submission and commercialization.
Second demonstrating tastes as clinical value by generating additional data with our strategically positioned research sites to support a regulatory submission and commercialization.
And third accelerating our commercial channel and marketing activities in line with the reopening of global markets to generate orders for tests in Europe .
Speaker Change: Third, accelerating our commercial channel and marketing activities in line with the reopening of global markets to generate orders for TAS in Europe .
Fourth securing additional pharmaceutical and other industry partnerships to expand the opportunity for tests outside the clinical end user market.
Speaker Change: Fourth, securing additional pharmaceutical and other industry partnerships to expand the opportunity for TAS outside the clinical end-users.
Speaker Change: And fifth, continuing to strengthen our intellectual property portfolio to protect our proprietary technology, expand its potential area of use, and increase outlays.
And fifth continuing to strengthen our intellectual property portfolio to protect our proprietary technology expand its potential area of use and increase out licensing opportunities.
Speaker Change: So with that review of our business highlights and our financial results, I'd like to open the call now to questions. Operator. Thank you.
With that review of our business highlights and our financial results I'd like to open the call now to questions operator.
Thank you.
We will now begin the question and answer session.
Speaker Change: To ask a question, you may press star then 1 on your telephone key back.
To ask a question you May press Star then one on your telephone keypad.
Speaker Change: If you're using a speakerphone, please pick up your handset before press.
If youre using a speakerphone please pick up your handset before pressing team.
Speaker Change: To withdraw your question, please press star then two.
To withdraw your question. Please press Star then two.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
At this time, we will pause momentarily to assemble our roster.
Speaker Change: Our first question comes from Ed Wu with Ascending Capital. Please go ahead.
Our first question comes from Ed Woo with <unk> capital. Please go ahead.
Yeah. Thanks for taking my question and congratulations on all of them.
Ed Blo: Yeah, thanks for taking my question and congratulations on all the progress you're doing particularly in Europe . Do you feel that your each country has equal opportunities or do you feel that you guys are more better established commercial operations in certain territories?
Progress you're doing particularly in Europe do you feel about your each country has equaled opportunities or do you feel that you guys are more better established commercial operations in certain territories.
Hi, yes, thanks for the question and for joining the call.
Speaker Change: I had. Yeah, thanks for the question for joining the call. I think our deployment historically of the four sales people across the key markets we listed Germany, France and the UK really represent what we think the biggest opportunities lie. Germany certainly the largest
Our deployment historically of the four salespeople across the key markets, we listed Germany, France, and the UK are really represent what we think the biggest opportunities lie Germany, certainly the largest health care market in Europe , but France, and the U K are very close behind so that's really where we're focusing where no.
Speaker Change: healthcare market in Europe , but France and the UK are very close behind. So that's really where we're focusing. We're no touched on our plan to, you know, as, as the market opportunities present themselves go into other markets, either through distribution partners,
<unk> on.
Our.
Planned too as as the market opportunities present themselves go into other markets either through our distribution partners or with Andrew our head count in markets that can bear premium prices potentially like Scandinavia, but I think to answer your question today, We've got a really good base of both.
Speaker Change: or with Endra headcount and markets that can bear premium prices potentially like Scandinavia. But I think to answer your question today, we've got a really good base of both
Speaker Change: commercial resources as well as clinical research partners in the top markets in Europe , and I think that's where we'll focus at first.
Sure.
Resources as well as clinical research partners in the top markets in Europe , and I think that's where we'll focus at first thanks for your question.
Speaker Change: Does your approval for TAF, is it EU-wide or is it country-by-country?
Does your approval for task is it EU wide or is it country by country.
Speaker Change: So, yeah, the CE mark does give us the ability to market the product in the 20 plus CE mark countries. And then at each level, we register the product locally with each market. So that is a follow on. But yes, that's the process. And so really, those countries certainly include the markets I've mentioned, plus all the other members of the EU.
So yeah, the CE Mark does give us the ability to.
Market the product in the 20, plus CE Mark countries and then at each level.
We register the product locally with each market. So that is a a follow on but yes. That's the process and so really those countries. Certainly include the markets I've mentioned plus all the other members of the EU.
Yeah.
Great and my last question is you know as you guys know.
Speaker Change: Great. And my last question is, you know, as you guys, you know, I guess prepare for the de novo filing for the USFBA, does that impact at all the distribution deal you have in Vietnam?
I guess to prepare for the de Novo filing for the U.
U S. FDA does that impact at all the distribution deal you have in Vietnam.
So good memory.
Speaker Change: So good memory and yeah, the distribution agreement we have signed in Vietnam will go live once we receive FDA approval. And so that is currently awaiting the FDA approval, but it's a good way to remind our listeners that we have this first.
Yeah. The distribution agreement, we have signed in <unk>.
Nam will go live once we receive FDA approval and so that is currently.
Awaiting the FDA approval, but it's a good way to remind our listeners that we have this first.
Speaker Change: of Vietnamese exclusive distributorship with a commitment of at least 40 systems once we receive FDA approval.
Yet enemies exclusive distributor shipped with a commitment of at least 40 systems once we receive FDA approval.
Speaker Change: And I do want to just reflect on the de novo pathway as something that's the culmination of a lot of discussion.
And I do want to just reflect on the de Novo pathway is something thats. The culmination of a lot of discussion with the FDA, it's been very productive it builds on our five 10-K submission.
Speaker Change: with the FDA. It's been very productive. It builds on our 510K submission and as I mentioned it is
As I mentioned it is very likely to afford Andrew some commercial.
Speaker Change: very likely to afford Andra's commercial.
Speaker Change: differentiation under the DeNovo approval that we would not otherwise have received under the 510K. So we're very excited about that and confident that we will receive FDA approval for the TAIS system. Thanks very much for your questions.
Differentiation under the de Novo approval that we would not otherwise have received under the 500 10-K. So we're very excited about that and confident that we will receive.
FDA approval for the <unk> system.
Thanks, very much for your questions.
Great. Thank you.
Operator, if we're.
Speaker Change: Operator, if we're not seeing any other questions, perhaps Yvonne Briggs on our investor relations partner is getting some questions online.
We're not seeing any other.
Questions, perhaps Yvonne Briggs on our Investor Relations partner was getting some questions online.
Yeah Francois could you provide some additional color on how your commercial efforts are being received in Europe , specifically from the endocrinology segment of the market.
Francois Michelon: Yeah, Francois, could you provide some additional color on how your commercial efforts are being received in Europe , but specifically from the endocrinology segment of the market? I think I'll let Renault speak to that since he's closest to it with his team on the ground. Renault?
Yeah.
I think I'll, let renaud speak to that says he's closest to it with his team on the ground Renault.
Reno: Yeah, François, that's a good question, actually. I certainly can tell you that our recent experience at the French Congress for Diabetology, we had a lot of interest clinician coming to our booth. I mean, we made about 60 very good new contacts here from France, Switzerland, Belgium, and other French-speaking countries as we demonstrated the test system and learn a lot more about the needs for endocrinologists. Clearly, I mean, this is a specialty that is focused on metabolic health.
Yes. Good question actually I, certainly can tell you that our recent experience at the crunch.
Congress for a diabetologist, we had a lot of interest clinician coming to our booth. We made about 60 very good new contacts here from France, Switzerland, Belgium, and other French speaking countries as we demonstrated the <unk> system and learn a lot more about the need for endocrinologists.
Clearly I mean this is a specialty those focus on metabolic health.
Reno: But, depending on the countries, of course, they may also need to be trained a little bit more on ultrasound than the radiology segment needs to be, which is not a big deal. What I think is exciting is that this segment is additive to the other markets that we've historically pursued that radiology and gastropathology. So, we basically have the opportunity to increase the pie that we are looking for.
But depending on the countries of course.
Also need to be trained and little bit more on ultrasound that then the radiology segment.
<unk>, which is not a big deal.
What I think is exciting is that the segment is it did it.
To the other markets that we have historically pursued like radiology and guests right mythology. So we basically have the opportunity to to increase the pie that we are we are looking at.
Thanks, Renaud and hopefully that answers your online question received Ivan.
Speaker Change: Thanks for an O, and hopefully that answers your online question received, Yvonne. Are there any other questions?
Are there any other questions.
That you see Yvonne or the operator please.
Speaker Change: that you see, Yvonne, or the operator, please.
Speaker Change: The last question, obviously there's a concern in the marketplace over global supply chain issues. Has Endra been impacted at all or do you have any concerns regarding the impact in the future?
Yeah. The last question.
There was a concern in the marketplace over our global supply chain issues has been impacted at all or do you have any concerns regarding the impact in the future.
Speaker Change: Yeah indeed a lot of companies are facing constraints and supply or distribution but thankfully we don't see supply chain issues affecting Andrew in the near term. In 2021 we made bulk buys of critical components and we continue to actively assess on
Yeah. Indeed, a lot of companies are facing constraints in supplier distribution, but thankfully, we don't see supply eight of supply chain issues affecting that or in the near term.
In 2021, we made bulk buys are critical components and we continue to actively assess our needs and suppliers to avoid issues. So I can't completely predict the future, but I think we're in good shape today.
Speaker Change: suppliers to avoid issues. So I can't completely predict the future, but I think we're in good shape today and we'll continue to very actively manage that situation over the coming months.
And we'll continue to very actively manage that situation over the coming months.
Thank you for that.
Yvonne and operator, I think if there are no more questions. We can proceed to close the call.
Speaker Change: If on and operator, I think if there are no more questions, we can proceed to close the call.
Thank you yes. This concludes our question and answer session I would like to turn the conference back over to Ron Paul for any closing remarks.
Speaker Change: Thank you. Yes, this concludes our question and answer session. I would like to turn the conference back over to Sren Swath for any closing remarks.
San Fran: Thank you, Operator, and just a closing thank you to our listeners, our investors, as well as the Andra team. We look forward to keeping you updated on our progress and speaking with you again in our next quarterly conference call, and I wish you all a good evening.
Thank you operator and just.
Clothing, thank you to our listeners our investors as well as the Andrew team. We look forward to keeping you updated on our progress and to speaking with you again on our next quarterly conference call and I wish you all a good evening.
Thank you. The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Thank you. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.