Q2 2024 Personalis Inc Earnings Call
Good day and welcome to the Personalis 2nd Quarter 2024 Earnings Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions.
Operator: 24-Earnings conference call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note that this event is being recorded.
Operator: for the Earnings Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions.
Caroline Corner: I would now like to third the call over to Caroline Corner, Investor Relation. Please go ahead.
Operator: After today's presentation, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the call over to Caroline Corner, Investor Relations.
Please note that this event is being recorded. I would now like to turn the call over to Caroline Corner, Investor Relations. Please go ahead.
Caroline Corner: Thank you, operator. Welcome to Personalis's second quarter 2024 earnings call. Joining today's call are Chris Hall. Chief Executive Officer and President, Aaron Tachibana; Chief Financial and Chief Operating Officer, and Rich Chen, Chief Medical Officer and EVP R&D.
Caroline Corner: Thank you, Operator. Welcome to Personalis' second quarter 2024 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President, Aaron Tachibana, Chief Financial and Chief Operating Officer, and Rich Chen, Chief Medical Officer and EVP R&D. All statements made on this call and do not relate to matters of historical fact should be considered forward-looking statements within the meaning of U.S. securities laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway, revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, cost expectations, our market opportunity, and business outlook.
Unknown Executive: Thank you, Operator. Welcome to Personalis's second quarter 2024 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President, Aaron Tachibana, Chief Financial and Chief Operating Officer, and Rich Chen, Chief Medical Officer and EVP R&D. All statements made on this call and do not relate to matters of historical fact should be considered forward-looking statements within the meaning of U.S. securities laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway, revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, cost expectations, our market opportunity, and business outlook.
Caroline Corner: Thank you, Operator. Welcome to Personalis' second quarter 2024 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President, Aaron Tachibana, Chief Financial and Chief Operating Officer, and Rich Chen, Chief Medical Officer and EVP R&D.
Unknown Executive: All statements made on this call do not relate to matters that the historical facts should be considered forward in statements within the meaning of US security laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway, revenue, expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, cost expectations, our market opportunity and business outlook. These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations.
Speaker Change: All statements made on this call and do not relate to matters of historical fact should be considered forward-looking statements within the meaning of U.S. securities laws.
For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway, revenue, expectations, and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions.
Speaker Change: Expectations for Existing and Future Collaboration Activities, Cost Expectations, Market Opportunity, and Business Outlook.
Caroline Corner: These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements, except as required by applicable law.
Unknown Executive: These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements, except as required by applicable law.
Caroline Corner: These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations.
Unknown Executive: We encourage you to review our most recent filings with the SEC, including the risk factors described in our most recent filings.
Caroline Corner: We encourage you to review our most recent filings with SEC, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements, except as required by applicable law.
Unknown Executive: Personalis undertakes no obligation to update these statements, except as required by applicable law.
Unknown Executive: Our press release is our second quarter 2024 results available on our website, www.personalis.com, under the investor's section that includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. Our recording of today's call will be available on our website by 5 p.m. Pacific Time today.
Caroline Corner: Our press release with our second quarter 2024 results is available on our website, www.Personalis.com, under the investor section that includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5 p.m. Pacific Time today.
Caroline Corner: Our press release with our second quarter 2024 results is available on our website www.Personalis.com under the Investors section and includes additional details about our financial results.
Caroline Corner: Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5 p.m. Pacific Time today. Now, I would like to turn the call over to Chris for his comments and second quarter business highlights.
Caroline Corner: Now I would like to turn the call over to Chris, but his comments and technical order of business highlights.
Chris Hall: Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. I'm very proud of our team at Personalis as we continue to fight cancer and help patients with our novel technology. For those of you joining one of our calls for the first time, welcome. Personalis is one of the leaders in the fast-growing MRD testing market. MRD stands for Minimal Residual Disease and involves using blood, which is commonly called a liquid biopsy, instead of imaging or invasive biopsies to monitor therapy and to detect cancer recurrence after treatment.
Chris Hall: Thank you, Caroline.
Chris Hall: Good afternoon, everyone, and thank you for joining us. I'm very proud of our team at Personalis as we continue to fight cancer and help patients with our novel technologies.
Chris: Thank you, Caroline. Good afternoon, everyone, and thank you for joining us.
Chris: I'm very proud of our team at Personalis as we continue to fight cancer and help patients with our novel technologies. For those of you joining one of our calls for the first time, welcome. Personalis is one of the leaders in the fast-growing MRD testing market.
Chris Hall: For those of you joining, one of our calls for the first time, welcome. Personalis is one of the leaders in the fast-growing MRD testing market. MRD stands for minimal residual disease and involves using blood, which is commonly called a liquid biopsy, instead of imaging or invasive biopsies to monitor therapy and to detect cancer recurrence after treatment. The MRD market is expected to mature into a $20 billion market, and with our first of its kind, ultra-sensitive MRD test, Personalis has emerged as a lure in the space. Our technologies are able to spot cancer when there's only about one fragment of tumor DNA circulating in a million DNA fragments in the blood.
Chris Hall: The MRD market is expected to mature into a $20 billion market, and with our first-of-its-kind ultra-sensitive MRD test, Personalis has emerged as a leader in this space. Our technologies are able to spot cancer when there's only about one fragment of tumor DNA circulating in a million DNA fragments in the blood. Our platforms are used by many of the world's top biopharma companies to improve clinical trial results, find new ways to personalize treatment, and empower a new generation of therapists.
Unknown Executive: MRD stands for Minimal Residual Disease and involves using blood, which is commonly called a liquid biopsy, instead of imaging or invasive biopsies to monitor therapy and to detect cancer recurrence after treatment. The MRD market is expected to mature into a $20 billion market, and with our first-of-its-kind ultra-sensitive MRD test, Personalis has emerged as a leader in this space.
Chris: MRD stands for Minimal Residual Disease and involves using blood, which is commonly called a liquid biopsy, instead of imaging or invasive biopsies to monitor therapy and to detect cancer recurrence after treatment.
Chris: The MRD market is expected to mature into a $20 billion market, and with our first-of-its-kind ultra-sensitive MRD test, Personalis has emerged as a leader in this space.
Unknown Executive: Our technologies are able to spot cancer when there's only about one fragment of tumor DNA circulating in a million DNA fragments in the blood. Our platforms are used by many of the world's top biopharma companies to improve clinical trial results, find new ways to personalize treatment, and empower a new generation of therapists. Now, this aspirational milestone has at its core three growth engines, and its effect has been to shift us into a higher growth mode. In the second quarter, we achieved revenue of $22.6 million, up 35% year over year.
Chris: Our technologies are able to spot cancer when there's only about one fragment of tumor DNA circulating in a million DNA fragments in the blood.
Chris Hall: Our platforms are used by many of the world's top bioparma companies to improve clinical trial results by new ways to personalize treatment and power a new generation of therapies. Earlier this year, we laid out our strategy to drive personalized to $100 million in revenue in 2025. Now, this aspirational milestone has, at its core, three growth engines, and its effect has been to shift us into a higher growth mode. In the second quarter, we achieved revenue of 22.6 million, up 35% year over year. This growth was driven by our bioparma business, which grew 117% year over year, led by strong demand for our tumor profiling product that is used to create personalized cancer vaccines for patients.
Chris: Our platforms are used by many of the world's top biopharma companies to improve clinical trial results, find new ways to personalize treatment, empower a new generation of therapies.
Chris Hall: Earlier this year, we laid out our strategy to drive Personalis to $100 million in revenue in 2025. Now, this aspirational milestone has at its core three growth engines, and its effect has been to shift us into a higher growth mode. In the second quarter, we achieved revenue of $22.6 million, up 35% year over year. This growth was driven by our biopharma business, which grew 117% year over year, led by strong demand for our tumor profiling product that is used to create personalized cancer vaccines for patients, as well as increasing demand for our MRD product next. Our strong Q2 revenue also helped us to increase our guidance for the full year by $3 million, and we now expect full-year revenue in the range of $79 to $81 million.
Chris: Earlier this year, we laid out our strategy to drive Personalis to $100 million in revenue in 2025.
Chris: Now this aspirational milestone has at its core three growth engines and its effect has been to shift us into a higher growth mode.
Chris: In the second quarter, we achieved revenue of $22.6 million, up 35% year-over-year.
Unknown Executive: This growth was driven by our biopharma business, which grew 117% year over year, led by strong demand for our tumor profiling product that is used to create personalized cancer vaccines for patients, as well as increasing demand for our MRD product next. Data across multiple studies now indicate we're able to see cancer recurrence earlier. And this holds out the promise that those patients can seek treatment sooner with potentially better outcomes. Our focus on these indications is intentional, and our data has demonstrated that Next Personal can win in these markets.
Chris: This growth was driven by our biopharma business, which grew 117% year over year, led by strong demand for our tumor profiling product that is used to create personalized cancer vaccines for patients, as well as increasing demand for our MRD product, NexPersonal.
Chris Hall: As well as increasing demand for MRD products next year. Personal. Our strong Q2 revenue also helped us to increase our guidance for the full year by three million, and we now expect full year revenue in the range of 79 to 81 million dollars. We're particularly pleased to have been able to deliver this top-line growth while also making improvements to both our cost and margins, as Aaron will cover shortly.
Chris: Our strong Q2 revenue also helped us to increase our guidance for the full year by $3 million and we now expect full year revenue in the range of $79 to $81 million.
Chris: We're particularly pleased to have been able to deliver this top-line growth while also making improvements to both our costs and margins, as Aaron will cover shortly.
Chris Hall: We're particularly pleased to have been able to deliver this top line growth while also making improvements to both our cost and margins, as Aaron will cover shortly. I'll now review progress this quarter on our three growth engines. First, the first growth engine, when in MRD, is the most important as we focus on turning Personalis into a clinical diagnostic powerhouse. As I noted, MRD testing uses liquid biopsy to find evidence of minimal residual disease or cancer recurrence and to monitor therapy effectiveness. We laid out our winning MRD strategy six quarters ago, and we've been executing on its four pillars.
Chris Hall: On our review progress this quarter on our three-on-our-growth three-growth engines. First, the first-growth engine, Women in MRD, is the most important as we focus on turning personality into a clinical diagnostic powerhouse. As I noted, MRD testing uses a liquid biopsy to find evidence of minimal residual disease or cancer recurrence and the monitor therapy effectiveness. We laid out our Women in MRD strategy six quarters ago, and we've been executing on its four pillars. One, focus on cancer types where an ultra-sensitive approach can unlock significant value for patients, payers, and partners to drive reimbursement by developing robust clinical evidence and partnering with the top global collaborators.
Aaron: I'll now review progress this quarter on our three growth engines. First, the first growth engine, when in MRD, is the most important as we focus on turning Personalis into a clinical diagnostic powerhouse.
Chris: As I noted, MRD testing uses a liquid biopsy to find evidence of minimal residual disease or cancer recurrence and to monitor therapy effectiveness.
Chris: We laid out our win-in MRD strategy six quarters ago, and we've been executing on its four pillars.
Chris Hall: Focus on cancer types where an ultrasensitive approach can unlock significant value for patients, payers, and partners. 2, drive reimbursement by developing robust clinical evidence and partnering with the top global collaborators. 3, leverage our deep relationships to accelerate adoption by biopharma partners and power our revenue growth through the use of NEXT personal and clinical trials. And four, commercialize NEXT personal with a partner-centric model.
Chris: 1. Focus on cancer types where an ultrasensitive approach can unlock significant value for patients, payers, and partners.
Chris: Q.
Chris: Drive reimbursement by developing robust clinical evidence and partnering with the top global collaborators.
Chris Hall: Three, leverage our deep relationships to accelerate adoption by biopharmate partners and power our revenue growth by the use of next personal and clinical trials and four commercialized next personal with a partner-centric model. Now to delve into the first pillar, we previously explained how we're developing evidence to support next personal's clinical usage and reimbursement in lung cancer, breast cancer, and IO therapy monitoring. The data across multiple studies now indicate we're able to seek cancer recurrence earlier, and this holds out the promise that those patients can seek treatment sooner with potentially better outcomes. The clinical studies that have been done to date indicate we can detect cancer many months ahead of imaging.
Chris: 3. Leverage our deep relationships to accelerate adoption by biopharma partners and power our revenue growth by the use of next personal and clinical trials, and 4. Commercialize next personal with a partner-centric model.
Chris Hall: Now, to delve into the first pillar, we've previously explained how we're developing evidence to support NEXT personal's clinical usage and reimbursement in lung cancer, breast cancer, and iotherapy models. The data across multiple studies now indicate we're able to see cancer recurrence earlier. And this holds out the promise that those patients can seek treatment sooner with potentially better outcomes. The clinical studies that have been done to date indicate that we can detect cancer many months ahead of imaging.
Chris: Now, to delve into the first pillar, we've previously explained how we're developing evidence to support next personals' clinical usage and reimbursement in lung cancer, breast cancer, and iotherapy monitored.
Chris: The data across multiple studies now indicate we're able to seek cancer recurrence earlier, and this holds out the promise that those patients can seek treatment sooner with potentially better outcomes.
Chris: The clinical studies that have been done to date indicate we can detect cancer many months ahead of imaging.
Chris Hall: The data also suggests that patients who are classified as MRD negative, meaning our test doesn't detect circulating DNA from the tumor, largely do not experience recurrence. Having more confidence than a negative result may allow a doctor to de-escalate patients from unnecessary therapies and procedures, potentially avoiding toxicities and ultimately saving the healthcare system money. Our focus on these indications is our is intentional and our data is demonstrated that next personal can win in these markets. To elaborate a bit on our approach, lung cancer and breast cancer should very little DNA in the blood, so cancer is difficult to detect without an ultra-sensitive approach.
Chris Hall: The data also suggests that patients who are classified as MRD negative, meaning our test doesn't detect circulating DNA from the tumor, largely do not experience recurrence. Having more confidence in a negative result may allow a doctor to deescalate patients from unnecessary therapies and procedures, potentially avoiding toxicities and ultimately saving health care. Our focus on these indications is intentional, and our data has demonstrated that next personal can win in these markets.
Chris: The data also suggests that patients who are classified as MRD negative, meaning our test doesn't detect circulating DNA from the tumor, largely do not experience recurrence.
Chris: Having more confidence in a negative result may allow a doctor to de-escalate patients from unnecessary therapies and procedures, potentially avoiding toxicities and ultimately saving the healthcare system money.
Speaker Change: Our focus on these indications is intentional, and our data has demonstrated that NextPersonal can win in these markets.
Chris Hall: To elaborate a bit on our approach, lung cancer and breast cancer shed very little DNA in the blood, so cancer is difficult to detect without an ultrasensitive approach. Lung and breast cancers can be aggressive when they recur, so early detection is critical. For patients on IOtherapy, we believe the potential decision to switch treatment requires the insights from monitoring that are provided by our ultrasensitive test. These factors make breast cancer, lung cancer, and therapy monitoring the ideal indications.
Unknown Executive: To elaborate a bit on our approach, lung cancer and breast cancer shed very little DNA in the blood, so cancer is difficult to detect without an ultrasensitive approach. These factors make breast cancer, lung cancer, and therapy monitoring the ideal indication. As we previously stated, our intention is to gradually add more doctors to the program until we receive reimbursement. Our quarter over quarter growth continues to be healthy, as we delivered 561 clinical tests in the second quarter, a 66% increase from the 338 results delivered in the first quarter of this year.
Chris: To elaborate a bit on our approach, lung cancer and breast cancer shed very little DNA in the blood, so cancer is difficult to detect without an ultrasensitive approach. Lung and breast cancers can be aggressive when they recur, so early detection is critical.
Chris Hall: Long and breast cancers can be aggressive when they recurso early detection is critical. For patients on IO therapy, we believe the potential decision to switch treatment requires the insights from monitoring that are provided by our ultra-sensitive test. These factors make breast cancer, lung cancer, and therapy monitoring the ideal indications for us.
Chris: For patients on iotherapy, we believe the potential decision to switch treatment requires the insights from monitoring that are provided by our ultrasensitive test.
Chris: These factors make breast cancer, lung cancer, and therapy monitoring the ideal indications for us.
Chris Hall: In October of 2023, we launched the first commercial ultra-sensitive MRD test into the clinic. Next personal has been marketed alongside our Medicare Reimverse tumor profiling text test next DX, which is used to help with patients on appropriate therapy. We started our commercial journey, which is 10 doctors in an early access program, and we've been adding incrementally. As we previously stated, our intention is to gradually add more doctors into the program until we receive re-inversement. Our quarter-over-quarter growth continues to be healthy as we delivered 561 clinical tests in the second quarter, a 66 percent increase from the 338 results delivered in the first quarter of this year.
Chris Hall: In October of 2023, we launched the first commercial ultrasensitive MRD test into the clinic. Next Personal is being marketed alongside our Medicare reimbursed tumor profiling test, Next DX, which is used to help put patients on appropriate therapy. We started our commercial journey with just 10 doctors in an early access program, and we've been adding more. As we previously stated, our intention is to gradually add more doctors to the program until we receive reimbursement.
Chris: In October of 2023, we launched the first commercial ultrasensitive MRD test into the clinic. NextPersonal is being marketed alongside our Medicare reimbursed tumor profiling test NextDx, which is used to help put patients on appropriate therapy.
Chris: we started our commercial journey which is ten doctors at an early access program and we've been adding inproment
Chris: As we previously stated, our intention is to gradually add more doctors into the program until we receive reimbursement.
Chris Hall: Our quarter over quarter growth continues to be healthy as we delivered 561 clinical tests in the second quarter, a 66% increase from the 338 results delivered in the first quarter of this year. In addition, Tempest commenced their commercial launch of next personal late in the second quarter, and we expect this to fuel additional growth.
Chris: Our quarter-over-quarter growth continues to be healthy, as we delivered 561 clinical tests in the second quarter, a 66% increase from the 338 in the first quarter.
Chris Hall: In addition, campus commenced their commercial launch of next personal late in the second quarter, and we expect this to fuel additional growth. Early feedback has been that clinicians are seeing a leap in action ability from our approach. If you remember, we report circulating tumor DNA in the blood down to one part per million, which means that if there is just one fragment of tumor DNA circulating in about a million DNA fragments in the blood, we expect to see it and quantify it. This is a leap forward in the field. The extra analytic sensitivity we report on with our next personal test and mask a region that has previously been hard to see.
Unknown Executive: In addition, Tempest commenced their commercial launch of NextPersonal late in the second quarter, and we expect this to fuel additional growth. Additionally, about 30% of the ctDNA positive samples in our clinical testing have been in this ultrasensitive range.
Speaker Change: Results delivered in the first quarter of this year. In addition, Tempest commenced their commercial launch of next personal late in the second quarter, and we expect this to fuel additional growth.
Chris Hall: Early feedback has been that clinicians are seeing a leap in actionability from our approach. If you remember, we report circulating tumor DNA in the blood down to one part per million, which means that if there is just one fragment of tumor DNA circulating in about a million DNA fragments in the blood, we expect to see it and quantify it. This is a leap forward in the field.
Speaker Change: Early feedback has been that clinicians are seeing a leap in actionability from our approach. If you remember, we report circulating tumor DNA in the blood down to one part per million, which means that if there is just one fragment of tumor DNA circulating in about a million DNA fragments in the blood.
Chris: We expect to see it and quantify it. This is a leap forward in the field. The extra analytic sensitivity we report on with our next personal test unmasks a region that has previously been hard to see consistently.
Chris Hall: The extra analytic sensitivity we report on with our next personal tests unmasks a region that has previously been hard to see. We call that region the ultra-sensitive MRD region. About 30% of the ctDNA positive samples in our clinical testing have been in this ultrasensitive brain. That is a jump in the actionability of MRD testing and means physicians can see cancer recurrence earlier, have more discrimination in monitoring therapy, and have more confidence that patients with negative ctDNA results are in fact cancer free.
Chris Hall: Assistantly. We call that region the ultra-sensitive MRD range. About 30% of the ctDNA positive samples in our clinical testing have been in this ultra-sensitive range. That is a jump in the action ability of MRD testing in mean physicians can see cancer recurrence earlier, have ward discrimination and monitoring therapy, and have more confidence that patients with negative ctDNA results are in fact cancer-free. Indeed, we've had many antidotes relayed from our early access doctors that the ultra-sensitive range is allowing them to seek cancer sooner and intervene with a patient to get them the management they need, and also to consider de-escalating therapy when our test determines patients are negative for ctDNA.
Chris: we call that region the altras sensitive mrd range about thirty percent of the ctpa positive samples and our clinicaltesting have been in this altra sensitive range
Chris: That is a jump in the actionability of MRD testing and means physicians can see cancer recurrence earlier, have more discrimination in monitoring therapy, and have more confidence that patients with negative ctDNA results are in fact cancer-free.
Chris Hall: Indeed, we've had many anecdotes from our early access doctors that the ultra-sensitive range is allowing them to see cancer sooner and intervene with a patient to get them the management they need, and also to consider de-escalating therapy when our test determines patients are negative for ctDNA. For example, a female patient from the Northeast receiving therapy for breast cancer tested positive with our next personal test. Her physician saw low traces of cancer in the ultra-sensitive range for several months.
Chris: Indeed, we've had many anecdotes relayed from our early access doctors.
Chris: that the ultra-sensitive range is allowing them to see cancer sooner and intervene with a patient to get them the management they need, and also to consider de-escalating therapy when our test determines patients are negative for ctDNA.
Chris Hall: For example, a female patient from the Northeast receiving therapy for breast cancer tested positive with our next personal test. Her position saw low traces of cancer in the ultra-sensitive range for over several months, and luckily for this patient, the detected levels trended downwards until the patient's cancer finally became undetectable. Continued monitoring can potentially help inform taking patients like this off-therapy in the future and provide reassurance to both the doctor and the patient.
Chris: For example, a female patient from the Northeast receiving therapy for breast cancer tested positive with our next personal test. Her physician saw low traces of cancer in the ultrasensitive range for over several months.
Chris Hall: Luckily for this patient, the detected levels trended downwards until the patient's cancer finally became undetected. Continued monitoring can potentially help inform taking patients like this off therapy in the future and provide reassurance to both the doctor and the patient.
Chris: And luckily for this patient, the detected levels trended downwards until the patient's cancer finally became undetectable. Continued monitoring can potentially help inform taking patients like this off therapy in the future and provide reassurance to both the doctor and the patient.
Chris Hall: Moving to our second pillar, we're focused on building and publishing clinical evidence to gain reimbursement and continue to work with many of the top fault leaders around the world. In previous calls and during the ASCO webinar, we've talked about the importance of our work with two of the leading cancer centers in Europe, Roe, Marston and breast cancer, and Valde Hebron for an immunotherapy monitoring. Both of these collaborators have provided access to studies that are broad and comprehensive. In the case of Roe, Marston and the Institute of Cancer Research in the UK, which are one of the leading global institutions at breast cancer, the study included patients across the major breast cancer subtypes, including HR, HER positive or two positive and triple-negative breast cancer in patients, who were followed in the study for a median of six years.
Chris Hall: Moving to our second pillar, we're focused on building and publishing clinical evidence to gain reimbursement and continue to work with many of the top fault leaders around the world. In previous calls and during the ASCO webinar, we talked about the importance of our work with two of the leading cancer centers in Europe, Royal Marsden in breast cancer and Valdehevran in immunotherapy monotherapy. Both of these collaborators have provided access to studies that are broad and comprehensive.
Unknown Executive: Moving to our second pillar, we're focused on building and publishing clinical evidence to gain reimbursement and continue to work with many of the top fault leaders around the world. In previous calls and during the ASCO webinar, we talked about the importance of our work with two of the leading cancer centers in Europe, Royal Marsden in breast cancer and Valdehebra in immunotherapy monotherapy.
Speaker Change: m to our second pillar we're focused on building and publishing clinical evidence to gain reimbursement to continue to work with finan a top ball leaders around the world
Speaker Change: In previous calls and during the ASCO webinar, we've talked about the importance of our work with two of the leading cancer centers in Europe , Royal Marston in breast cancer and Valdehebra in immunotherapy monitoring. Both of these collaborators have provided access to studies that are broad and comprehensive.
Chris Hall: In the case of Royal Marston and the Institute of Cancer Research in the UK, which are one of the leading global institutions in breast cancer, the study included patients across the major breast cancer subtypes, including HR positive, HER2 positive, and triple negative breast cancer, and patients were followed in this study for a mean of six years. The study results were highlighted at ASCO during a podium presentation, and the results were compelling.
Chris: In the case of Royal Marston and the Institute of Cancer Research in the UK,
Chris: which are one of the leading global institutions in breast cancer. The study included patients across the major breast cancer subtypes.
Chris: including HR, HER-positive, HER-2 positive, and triple negative breast cancer in patients.
Chris Hall: The study results were highlighted at ASCO during a podium presentation, and the results were compelling. Next, personal detected early stage breast cancer, a medium of 15 months before imaging scans for patients. For Valde Hebron or VHIO, the work is in pan cancer and included greater than 120 patients across 18 different cancer subtypes. The study shows that next personal could be potentially used to predict immunotherapy response for patients. Similar to what we were seeing with our breast cancer studies, our test is detecting traces of cancer well ahead of imaging scans. These were all Marston results in the VHIO studies from immunotherapy monitoring, joining our Tracer X working lung cancer to form the backbone of our efforts to gain Medicare reimbursement.
Chris: were followed in this study for a medium of six years.
Speaker Change: The study results were highlighted at ASCO during a podium presentation and the results were compelling. Next, personal detected early stage breast cancer a medium of 15 months before imaging scans for patients.
Chris Hall: Next, the team detected early stage breast cancer, a medium of 15 months before imaging scans for patients. For Valdeheberin, or VHIO, the work is in pan-cancer and included greater than 120 patients across 18 different cancer subtypes. The study showed that NexPersonal could be potentially used to predict immunotherapy response for patients. Similar to what we are seeing with our breast cancer studies, our test is detecting traces of cancer well ahead of it. These Royal Marston results in the VHIO studies for immunotherapy monitoring join our TRACER-X work in lung cancer to form the backbone of our efforts to gain Medicare reimbursement.
Operator: 24-Earnings Conference Call. All participants will be in listen only mode. After today's presentation there will be an opportunity to ask questions. Please note that this event is being recorded.
Valdehevran: For Valdehevran, or VHIO, the work is in pan-cancer and included greater than 120 patients across 18 different cancer subtypes.
Speaker Change: The study showed that NexPersonal could be potentially used to predict immunotherapy response for patients. Similar to what we are seeing with our breast cancer studies, our test is detecting traces of cancer well ahead of imaging scans.
Caroline Corner: I would now like to third the call over to Caroline Corner, investor relation. Please go ahead. Thank you, operator.
Caroline Corner: Welcome to Personalis's second quarter, 2024 earnings call. Joining today's call are Chris Hall. Chief Executive Officer and President, Aaron Tachibana, Chief Financial and Chief Operating Officer, and Rich Chen, Chief Medical Officer and EVP R&D. All statements made on this call do not relate to matters that the historical facts should be considered forward in statements within the meaning of US security laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway, revenue, expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, cost expectations, our market opportunity and business outlook.
Speaker Change: These Royal Martinson results in the VHIO studies for immunotherapy monitoring join our TRACER-X work in lung cancer to form the backbone of our efforts to gain Medicare reimbursement.
Unknown Executive: Investigators in all three of these studies, Roe Marston, DHIO, and Tracer X. Once those manuscripts are published, we can then submit the individual dossiers for each of the indications to Medicare.
Chris Hall: Investigators in all three of these studies, Roe Marston, DHIO, and Tracer X, are working to submit manuscripts to peer-reviewed journals, which is a key step for us to ultimately submit for Medicare reimbursement. Once those manuscripts are published, we can then submit the individual dossiers for each of the indications to Medicare. There were two other data sets at ASCO that highlighted next personal that are also, One with his...
Chris Hall: Investigators in all three of these studies, Roe Marston, VHIO, and Tracer X, are working to submit manuscripts to peer review journals, which is a key step for us ultimately to submit for Medicare reimbursement. Once those manuscripts are published, we can then submit the individual dossiers for each of the indications to Medicare.
Chris: Investigators in all three of these studies, Roe Marston, DHIO, and Tracer X.
Chris: are working to submit manuscripts to peer-reviewed journals, which is a key step for us ultimately to submit for Medicare reimbursement.
Chris: Once those manuscripts are published, we can then submit the individual dossiers for each of the indications to Medicare. There were two other data sets at ASCO that highlighted Next Personal that are also worth noting.
Chris Hall: There were two other datasets at ASCO that highlighted next personal that are also worth noting. One was the study with Dana Farber for her two positive patients that showed next personal was correlated with outcomes and patients receiving neo-adjuvant therapy. Neo-adjuvant therapy is given to these patients before surgery to try to shrink the tumor before the cancer is removed. and a second study, this one with Duke, deepened the data indicating next personal could be used to predict immunotherapy response. The third pillar of our next personal strategy is to leverage our bioformer relationships to drive the use of next personal and clinical trials.
Chris Hall: Next Personal was correlated with outcomes in patients receiving neoadjuvant therapy. Neoadjuvant therapy is given to these patients before surgery to try to shrink the tumor before the cancer is removed.
Chris: One was a study with Dana Farber for her two positive patients that showed next personal was correlated with outcomes in patients receiving neoadjuvant therapy. Neoadjuvant therapy is given to these patients before surgery to try to shrink the tumor before the cancer is removed.
Caroline Corner: These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with SEC, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements except is required by applicable law. Our press release is our second quarter, 2024 results available on our website, www.personalis.com, under the investor's section that includes additional details about our financial results. Our website also has our latest SEC filings which we encourage you to review. Our recording of today's call will be available on our website by 5 p.m. Pacific Time Today.
Chris Hall: In a second study, this one with Duke, deepened the data indicating Next Personal could be used to predict immunotherapy. The third pillar of our Next Personal strategy is to leverage our biopharma relationships to drive the use of Next Personal in clinical trials. We're engaged with the most Excuse me, with most of the world's top biopharma companies that have continued to generate excitement around our next personal test, most recently in discussions at Ask.
Unknown Executive: In a second study, this one with Duke, deepened the data indicating next generation personal could be used to predict immunotherapy, an excellent approach to optimize biopharma trials. We have booked millions of dollars of revenue from biopharma customers for MRG projects to date and expect the growth to accelerate. Now move on to the fourth and final pillar, commercializing the next person in the clinical market using a partner-centric model. Overall, the deal is worth approximately $30 million for Personalis should all milestone payments be triggered and if Tempest fully exercises their warrant, minimal additional cash investment, and our teams work well together. We're confident that we're creating something great for doctors, patients, and payers.
Chris: In a second study, this one with Duke, deepened the data indicating next personal could be used to predict immunotherapy response.
Speaker Change: The third pillar of our Next Personal strategy is to leverage our biopharma relationships to drive the use of Next Personal in clinical trials. We're engaged with the most...
Chris Hall: We're engaged with the most, excuse me, with most of the world's top bioformer companies and have continued to generate excitement around our next personal test, most recently from discussions at ASCO. Customers want to need an ultra-sensitive approach to ensure that most appropriate patients enter into clinical trials. For example, we believe that our ultra-sensitive aspect means that patients testing negative are much less likely to have a recurrence. Our bioformer customers can then expect that these patients are less likely to benefit from a therapeutic intervention. Holding out the promise that next personal would be an excellent approach to optimize bioformer trials.
Chris: Excuse me. With most of the world's top biopharma companies that have continued to generate excitement around our next personal test, most recently from discussions at ASCO.
Chris Hall: Customers want and need an ultra-sensitive approach to ensure that the most appropriate patients enter into clinical trials. For example, we believe that our ultra-sensitive assay means that patients testing negative are much less likely to have a reaction.
Chris: Customers want and need an ultrasensitive approach to ensure that the most appropriate patients enter into clinical trials. For example, we believe that our ultrasensitive assay means that patients testing negative are much less likely to have a recurrence.
Christopher Hall: Now I would like to turn the call over to Chris, but his comments and technical order of business highlights. Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. I'm very proud of our team at Personalis as we continue to fight cancer and help patients with our novel technologies. For those of you joining, one of our calls for the first time, welcome. Personalis is one of the leaders in the fast-growing MRD testing market.
Chris Hall: Our Biopharma customers can then expect that these patients are less likely to benefit from a therapeutic intervention. Holding out the promise that next person, an excellent approach to optimize biopharma trials. We have booked millions of dollars of revenue from biopharma customers for MRG projects to date and expect the growth to accelerate. Now move on to the fourth and final pillar, commercializing the next person in the clinical market using a partner-centric model.
Chris: Our biopharma customers can then expect that these patients are less likely to benefit from a therapeutic intervention.
Chris: Holding out the promise that next personal will be an excellent approach to optimize biopharma trials.
Chris Hall: We have booked millions of dollars of revenue from bioformer customers from emerging projects today and expect the growth to accelerate.
Christopher Hall: MRD stands for minimal residual disease and involves using blood which is commonly called a liquid biopsy instead of imaging or invasive biopsies to monitor therapy and to detect cancer recurrence after treatment. The MRD market is expected to mature into a $20 billion market and with our first of its kind, ultra-sensitive MRD test, personalis is emerged as a lure in the space. Our technologies are able to spot cancer when there's only about one fragment of tumor DNA circulating in a million DNA fragments in the blood.
Chris: We have booked millions of dollars of revenue from biopharma customers for MRG projects to date and expect the growth to accelerate.
Chris Hall: Now move on to the fourth and final pillar. Visualize the next personal in the clinical market using a partner-centered model. In December, we announced our key partnership with Tempest to work commercialize next personal in the clinics with oncologists. And recently, Tempest announced the launch of our products to their customers. To quickly review, we expect to leverage Tempest's 200 plus salespeople channel to co-commercialize next personal and accelerate growth. Personals will be responsible for processing samples in our lab, obtaining reimbursement, invoicing health insurance payers and patients under the arrangement, while paying Tempest fair market value for the commercial services they provide to us.
Chris: Now, move on to the fourth and final pillar, commercializing the next person on the clinical market using a partner-centric model.
Chris Hall: In December, we announced our key partnership with Tempest to commercialize NexPersonal in clinics with oncologists, and recently, Tempest announced the launch of our products to their, To quickly review, we expect to leverage the 200 plus salespeople channel to co-commercialize Next Personal Accelerator, will be responsible for processing samples in our lab, obtaining reimbursement, invoicing health insurance payers and patients under the arrangement, while paying Tempus fair market Overall, the deal is worth approximately $30 million for Personalis should all milestone payments be triggered and if Tempest fully exercises its warrant.
Chris: In December , we announced our key partnership with Tempus to commercialize NexPersonal in the clinics with oncologists, and recently, Tempus announced the launch of our products to their customers.
Chris: To quickly review, we expect to leverage Tempest's 200-plus salespeople channel to co-commercialize next personal Accelerate group.
Christopher Hall: Our platforms are used by many of the world's top bioparma companies to improve clinical trial results by new ways to personalize treatment and power and new generation of therapies. Earlier this year, we laid out our strategy to drive personalized to $100 million in revenue in 2025. Now, this aspirational milestone has that its core, three growth engines and its effect has been to shift us into a higher growth mode. In the second quarter, we achieved revenue of 22.6 million up 35% year over year.
Chris: Personalis will be responsible for processing samples in our lab, obtaining reimbursement, invoicing health insurance payers and patients under the arrangement, while paying Tempest Fairmarket value for the commercial services they provide to us.
Chris Hall: Overall, the deal is worth approximately 30 million for personnel should all milestone payments be triggered and if Tempest fully exercises their awards. We expect this to allow us to ramp up commercial efforts quickly, with minimal additional cash investments. We're now on the Tempest requisition, and we're processing samples sent to our lab. The goal for the balance of the year is to purposely grow our efforts together, learning how to work seamlessly as partners, integrating our business systems, and refining our message to oncologists. This way, we're set to drive accelerated growth together on the backside of reimbursement approval.
Chris: Overall, the deal is worth approximately $30 million for Personalis should all milestone payments be triggered and if Tempest fully exercises their warrants.
Chris Hall: We expect this to allow us to ramp up commercial efforts quickly with minimal additional cash investment. We're now on the Tempest requisition, and we're processing samples sent to our lab. The goal for the balance of the year is to purposely grow our efforts together, learning how to work seamlessly as partners, integrating our business systems, and refining our message to oncologists. In this way, we're set to drive accelerated growth together on the backside of reimbursement. The Tempest relationship is working extremely well today because of our cultures.
Chris: We expect this to allow us to ramp up commercial efforts quickly with minimal additional cash investment.
Christopher Hall: This growth was driven by our bioparma business which grew 117% year over year led by strong demand for our tumor profiling product that is used to create personalized cancer vaccines for patients. As well as increasing demand for MRD products next year. Personal. Our strong Q2 revenue also helped us to increase our guidance for the full year by three million and we now expect full year revenue in the range of 79 to 81 million dollars.
Chris: We're now on the Tempest requisition and we're processing samples sent to our lab. The goal for the balance of the year is to purposely grow our efforts together, learning how to work seamlessly as partners, integrating our business systems, and refining our message to oncologists.
Chris: This way, we're set to drive accelerated growth together on the backside of reimbursement approval.
Chris Hall: The Tempest relationship is working extremely well today. Our cultures and our teams work well together, and we're confident that we're creating something great for doctors, patients, and payers.
Chris: The Tempest relationship is working extremely well today. Our cultures and our teams work well together, and we're confident that we're creating something great for doctors, patients, and payers.
Chris Hall: And our teams work well together, and we're confident that we're creating something great for doctors, patients, and payers. While we made strides with our first growth engine, our win in MRD strategy to establish NexPersonal as a leading MRD test, we've also made progress with our second growth engine, leveraging our ImmunoID NexPlatform to deepen relationships with biopharma customers who use the offering to pioneer new therapies. Our biopharmaceutical business grew 117% year over year, and we had solid performance across our product portfolio.
Christopher Hall: We're particularly pleased to have been able to deliver this top-line growth while also making improvements to both our cost and margins as Aaron will cover shortly. On our review progress this quarter on our three-on-our-growth three-growth engines.
Chris Hall: While we made strides with our first growth engine, our winning MRD strategy to establish next person with a leading MRD test. We've also made progress with our second growth engine, leveraging our amino-ID Next platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies. Our biopharma business grew 117 percent year over year, and we had solid performance across our product portfolio. Customers primarily use our amino-ID Next platform in two ways. First, they leverage our platform to power translational research and find new biomarkers and insights that can enable their drug discovery efforts.
Unknown Executive: While we made strides with our first growth engine, our win in MRD strategy to establish NextPersonal as a leading MRD test, we've also made progress with our second growth engine, leveraging our ImmunoID Next platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies. Customers primarily use our ImmunoID Next platform in two ways. First, they leverage our platform to power translational research and find new biomarkers and insights that can enable their drug discovery efforts.
Chris: While we made strides with our first growth engine, our win in MRD strategy to establish NextPersonal as a leading MRD test, we've also made progress with our second growth engine, leveraging our ImmunoID Next platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies.
Christopher Hall: First, the first-growth engine, Women in MRD is the most important as we focus on turning personality into a clinical diagnostic powerhouse. As I noted, MRD testing uses a liquid biopsy to find evidence of minimal residual disease or cancer recurrence and the monitor therapy effectiveness. We laid out our Women in MRD strategy six quarters ago and we've been executing on its four pillars. One, focus on cancer types where an ultra-sensitive approach can unlock significant value for patients, payers and partners to drive reimbursement by developing robust clinical evidence and partnering with the top global collaborators.
Chris: Our biopharma business grew 117% year-over-year, and we had solid performance across our product portfolio. Customers primarily use our ImmunoID Next platform in two ways.
Chris Hall: Customers primarily use our ImmunoID Next platform in two ways. First, they leverage our platform to power translational research and find new biomarkers and insights that can enable their drug discovery efforts. Second, companies in the personalized cancer vaccine or the PCV market use our platform to create a molecular fingerprint of a patient's tumor to develop personalized therapy. We previously told you about our partnership with Moderna, in which Moderna is utilizing our platform in their mRNA cancer program.
Chris: First, they leverage our platform to power translational research and find new biomarkers and insights that can enable their drug discovery efforts.
Chris Hall: Second, companies in the personalized cancer vaccine or the PCD market use our platform to create a molecular fingerprint of a patient's tumor to develop personalized therapy. Therapy. We previously told you about our partnership with Moderna in which Moderna is utilizing our platform in their M or an A cancer program. Moderna and its partner, Merck, rolling patients, and our collaboration with Moderna is important for our revenue for us in 2024 and 2025. We have several other partners that work in the space as well.
Chris: Second, companies in the personalized cancer vaccine or the PCV market use our platform to create a molecular fingerprint of a patient's tumor to develop personalized therapy.
Unknown Executive: We previously told you about our partnership with Moderna, in which Moderna is utilizing our platform in their mRNA cancer program. Moderna and its partner Merck are enrolling patients, and our collaboration with Moderna is an important driver of revenue for us in 2024 and 2025. We have several other partners that work in the space as well, and we are growing our personalis inside approach as we service enterprise customers. As planned, they've reached the point where they can now run the product in their lab, and we expect to wind down our work with Niterra by the end of 2024. We have no intention to extend the current commercial arrangement.
Christopher Hall: Three, leverage our deep relationships to accelerate adoption by biopharmate partners and power our revenue growth by the use of next personal and clinical trials and four commercialized next personal with a partner-centric model. Now to delve into the first pillar, we previously explained how we're developing evidence to support next personal's clinical usage and reimbursement and lung cancer, breast cancer, and IO therapy monitoring. The data across multiple studies now indicate we're able to seek cancer recurrence earlier and this holds out the promise that those patients can seek treatment sooner with potentially better outcomes.
Chris: We previously told you about our partnership with Moderna in which Moderna is utilizing our platform in their mRNA cancer program.
Chris Hall: Moderna and its partner Merck are enrolling patients, and our collaboration with Moderna is an important driver of revenue for us in 2024 and 2025. We have several other partners that work in the space as well. The third engine of our growth is growing our personalis inside approach as we service enterprise customers.
Chris: Moderna and its partner Merck are enrolling patients, and our collaboration with Moderna is an important driver of revenue for us in 2024 and 2025. We have several other partners that work in this space as well.
Chris Hall: The third engine of our growth is growing our personalism side approach as we service enterprise customers. In these relationships, partners adopt our platforms and technologies to power their solutions. For example, NETARA has leveraged our exome platform as a part of their MRD product health and scale while they work to build and house capabilities. As planned, they've reached a point where they can now run the product in their lab, and we expect to wind down our work with NETARA by the end of 2024, and we have no intention to extend the current commercial arrangement. With other strategic parts of our business accelerating quickly, PCV, BioFarm MRD projects, and our clinical diagnostic business, the additional capacity will shift to support those critical parts of our business.
Chris: The third engine of our growth
Chris: is growing our personalis inside approach as we service enterprise customers.
Chris Hall: In these relationships, partners adopt our platforms and technologies to power their solutions. For example, Natara has leveraged our Exome platform as a part of their MRD product to help them scale while they work to build in-house capabilities. As planned, they've reached the point where they can now run the product in their lab, and we expect to wind down our work with Niterra by the end of 2024. We have no intention to extend the current commercial arrangement.
Chris: In these relationships, partners adopt our platforms and technologies to power their solutions.
Speaker Change: For example, Natera has leveraged our Exome platform as a part of their MRD product to help them scale while they work to build in-house capabilities.
Christopher Hall: The clinical studies that have been done to date indicate we can detect cancer many months ahead of imaging. The data also suggests that patients who are classified as MRD negative meaning our test doesn't detect circulating DNA from the tumor largely do not experience recurrence. Having more confidence than a negative result may allow a doctor to de-escalate patients from unnecessary therapies and procedures, potentially avoiding toxicities and ultimately saving the healthcare system money.
Speaker Change: As planned, they've reached the point where they can now run the product in their lab and we expect to wind down our work with Niterra by the end of 2024. We have no intention to extend the current commercial arrangement.
Chris Hall: With other strategic parts of our business accelerating quickly, PCV, BioPharm MRD projects, and our clinical diagnostic business, the additional capacity will shift to support those critical parts of our. I should also note we're having other discussions exploring scaling up enterprise work in 2025. A second important enterprise relationship is the VA. Now, the VA utilizes our whole genome sequencing capabilities to power the Million Veteran Program, a national research program looking at how genes and lifestyle affect health in veterans.
Unknown Executive: With other strategic parts of our business accelerating quickly, PCV, biopharm MRD projects, and our clinical diagnostic business, the additional capacity will shift to support those critical parts of our. I should also note we're having other discussions exploring scaling up enterprise work in 2025. A second important enterprise relationship is the VA. Before I turn it over to Aaron, I have a couple of important corporate updates. First, we recently completed an agreement with Myriad Genetics to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease, or MRD.
Chris: With other strategic parts of our business accelerating quickly, PCV, BioPharm MRD projects, and our clinical diagnostic business, the additional capacity will shift to support those critical parts of our business.
Christopher Hall: Our focus on these indications is our is intentional and our data is demonstrated that next personal can win in these markets. To elaborate a bit on our approach, lung cancer and breast cancer should very little DNA in the blood, so cancer is difficult to detect without an ultra-sensitive approach. Long and breast cancers can be aggressive when they recurso early detection is critical. For patients on IO therapy, we believe the potential decision to switch treatment requires the insights from monitoring that are provided by our ultra-sensitive test. These factors make breast cancer, lung cancer, and therapy monitoring the ideal indications for us.
Chris Hall: I should also know we're having other discussions exploring scaling up enterprise work in 2025.
Chris: I should also note we're having other discussions exploring scaling up enterprise work in 2025.
Chris Hall: A second important enterprise relationship is the VA. The VA utilizes our whole genome sequencing capabilities to power the Million Veteran Program, a national research program looking at how genes and lifestyle affect health and veterans. We've helped power this program with the VA for over 10 years. The VA informs us this quarter that they plan to renew the contract another year, and we expect to receive a new purchase order by the end of September.
Chris: A second important enterprise relationship is the VA.
Speaker Change: the viaa utilizes our whole genome sequencing capabilities to power the million vebetterter of program and national research program looking at how genins and lifestyle effect health and veterans
Chris Hall: We've helped power this program with the VA for over 10 years. The VA informed us this quarter that they plan to renew the contract another year, and we expect to receive a new purchase order by the end of the year.
Speaker Change: We've helped power this program with the VA for over 10 years. The VA informed us this quarter that they plan to renew the contract another year, and we expect to receive a new purchase order by the end of September .
Chris Hall: Before I turn it over to Aaron, I have a couple of important corporate updates. First, we recently completed an agreement with Myriad Genetics to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease, or MRD. Both companies value tumor-informed approaches for cancer patients and have developed deep foundational patent estates in the field, and each sees the benefits of an ultrasensitive approach as key to making MRD testing the standard of care.
Chris Hall: Before I turn it over to Aaron, I have a couple of important corporate updates. First, we recently completed an agreement with Myriad Genetics to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease or MRD. Both companies value tumor-informed approaches for cancer patients and have developed deep foundational patent estates in the field, and each sees the benefits of an ultra-sensitive approach as key to making MRD testing standard of care. The agreement we entered into helps solidify our each company's freedom to operate in the MRD market and broadens access to the benefits of MRD testing for cancer patients.
Chris Hall: The agreement we entered into helps solidify each company's freedom to operate in the MRD market and broadens access to the benefits of MRD testing for cancer patients. Personalis and Myriad are each pioneering tumor-informed genome-scale approaches to power ultrasensitive MRD tests, enabling cancer recurrent detection early and more refined therapy monitoring than alternative approaches.
Unknown Executive: Both companies value tumor-informed approaches for cancer patients and have developed deep foundational patent estates in the field, and each sees the benefits of an ultrasensitive approach as key to making MRD testing the standard of care. The agreement we entered into helps solidify each company's freedom to operate in the MRD market and broadens access to the benefits of MRD testing for cancer patients. Personalis and Myriad are each pioneering tumor-informed genome-scale approaches to power the ultrasensitive MRD Test, Enabling Cancer Recurrent Detection Early and More Refined Therapy Monitoring than Alternative Approaches
Chris: from
Speaker Change: Before I turn it over to Aaron, I have a couple of important corporate updates. First, we recently completed an agreement with Myriad Genetics to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease, or MRD.
Christopher Hall: In October of 2023, we launched the first commercial ultra-sensitive MRD test into the clinic. Next personal has been marketed alongside our Medicare Reimverse tumor profiling text test next DX, which is used to help with patients on appropriate therapy. We started our commercial journey which is 10 doctors in an early access program and we've been adding incrementally. As we previously stated, our intention is to gradually add more doctors into the program until we receive re-inversement.
Speaker Change: Both companies value tumor-informed approaches for cancer patients and have developed deep foundational patent estates in the field, and each sees the benefits of an ultrasensitive approach as key to making MRD testing the standard of care.
Speaker Change: The agreement we entered into helps solidify each company's freedom to operate in the MRD market and broadens access to the benefits of MRD testing for cancer patients. Personalis and Myriad are each pioneering tumor-informed genome-scale approaches to power ultrasensitive...
Christopher Hall: Our quarter over quarter growth continues to be healthy as we delivered 561 clinical tests in the second quarter, a 66 percent increase from the 338 results delivered in the first quarter of this year. In addition, campus commenced their commercial launch of next personal late in the second quarter and we expect this to fuel additional growth. Early feedback has been that clinicians are seeing a leap in action ability from our approach. If you remember, we report circulating tumor DNA in the blood down to one part per million, which means that if there is just one fragment of tumor DNA circulating in about a million DNA fragments in the blood, we expect to see it and quantify it. This is a leap forward in the field. The extra analytic sensitivity we report on with our next personal test and mask a region that has previously been hard to see.
Chris Hall: Personalis and MRD and Myriad are each pioneering tumor-informed genome-scale approaches to power ultra-sensitive MRD tests, enabling cancer recurrent detection early or in more refined therapy monitoring than alternative approaches. Additionally, we settled our litigation with Forsyte, which resulted in us granting them a license to our MRD patents.
Speaker Change: inr d test enabling cancer recurrent this tection early are and more refined therapy monitoring and alternative approaches
Chris Hall: Additionally, we settled our litigation with Foresight, which resulted in us granting them a license to our MRD patents. This is a great outcome for Personalis. One, our IP that we've developed over many years is valuable. We were able to show that, and we'll be paid royalties moving forward. And secondly, we can focus on running our business and putting litigation costs aside. Both the cross-license agreement with Myriad and the settlement should give investors confidence in the value of our IP, the strength of its protection, and our ability to create value. With that, I'll now turn it over to Aaron to review our financials.
Unknown Executive: Additionally, we settled our litigation with Foresight, which resulted in us granting them a license to our MRD patents. This is a great outcome for Personalis. One, our IP that we've developed over many years is valuable. We were able to show that, and we'll be paid royalties moving forward. And secondly, we can focus on running our business and putting litigation costs aside. Both the cross-license agreement with Myriad and the settlement should give investors confidence in the value of our IP, the strength of its protection, and our ability to create value. With that, I'll now turn it over to Aaron to review our financials.
Speaker Change: Additionally, we settled our litigation with Foresight, which resulted in us granting them a license to our MRD patents.
Chris Hall: This is a great outcome for personalises. One, our IP that we've developed over many years, is valuable. We were able to show that, and we'll be paid royalties moving forward. Secondly, we can focus on running our business and putting litigation costs behind this. Both the cross-license agreement with Myriad and the settlement should give investors confidence in the value of our IP, the strength of its protection, and our ability to create value from it.
Speaker Change: This is a great outcome for Personalis. One, our IP that we've developed over many years is valuable. We were able to show that, and we'll be paid royalties moving forward. And secondly, we can focus on running our business and putting litigation costs behind us.
Speaker Change: Both the cross-license agreement with Myriad and the settlement should give investors confidence in the value of our IP, the strength of its protection, and our ability to create value from it. With that, I'll now turn it over to Aaron to review our financial results.
Aaron Tachibana: With that, I'll now turn it over to Aaron to review our financial results.
Christopher Hall: Assistantly. We call that region the ultra-sensitive MRD range. About 30% of the CTDNA positive samples in our clinical testing have been in this ultra-sensitive range. That is a jump in the action ability of MRD testing in mean physicians can see cancer recurrence earlier, have ward discrimination and monitoring therapy, and have more confidence that patients with negative CTDNA results are in fact cancer-free. Indeed, we've had many antidotes relayed from our early access doctors that the ultra-sensitive range is allowing them to seek cancer sooner and intervene with a patient to get them the management they need, and also to consider de-escalating therapy when our test determines patients are negative for CTDNA.
Aaron Tachibana: Thank you, Chris. Total company revenue for the second quarter, 2024, was $22.6 million and increased by 35% compared with $16.7 million for the same period of the prior year. The increase in revenue was driven by higher volume from Bioforma and personalized cancer vaccine customers, which was partially offset by declines from the BAMV page. Bioforma revenue grew 117 percent compared to the same period last year, and the growth was primarily from Amino ID Next. In addition, we recognized 0.1 million of clinical revenue from our next DX tumor profiling test. Growth margin expanded to 35.6 percent for the second quarter compared to 28.7 percent for the same period at the prior year.
Aaron Tachibana: Total company revenue for the second quarter of 2024 was $22.6 million, an increase of 35% compared with $16.7 million from the same period of the prior year. The increase in revenue was driven by higher volume from biopharma and personalized cancer vaccine customers. Biopharma revenue grew 117% compared to the same period last year, and the growth was primarily from the Immuno ID net.
Aaron Tachibana: Total company revenue for the second quarter of 2024 was $22.6 million, an increase of 35% compared with 16.7 million from the same period of the prior year. The increase in revenue was driven by higher volume from biopharma and personalized cancer vaccine customers, which was partially offset by declines from the BAMV paper. Biopharma revenue grew 117% compared to the same period last year, and the growth was primarily from the immuno ID net.
Aaron: Thank you, Chris. Total company revenue for the second quarter, 2024, was $22.6 million, an increase of 35% compared with $16.7 million for the same period of the prior year.
Aaron: The increase in revenue was driven by higher volume from biopharma and personalized cancer vaccine customers.
Aaron: which was partially offset by declines from the BAMV page.
Speaker Change: BioPharma revenue grew 117% compared to the same period last year, and the growth was primarily from ImmunoID Next.
Aaron Tachibana: In addition, we recognize $0.1 million of clinical revenue from our next DX tumor profiling test. Gross margin expanded to 35.6% for the second quarter compared with 28.7% for the same period of the prior year. The year-over-year increase of 6.9 percentage points was primarily due to product cost reduction and operating leverage from the 35% increase in revenue. Over the last year and a half, our focus has been to reduce product costs and reduce lab operations expenses to drive margins higher. Recall that just a few quarters ago, our gross margin was only 19%. So we are making very good progress.
Aaron Tachibana: In addition, we recognize 0.1 million of clinical revenue from our next DX tumor profiling test. Gross margin expanded to 35.6% for the second quarter, compared with 28.7% for the same period of the prior year. The year over year increase of 6.9 percentage points was primarily due to product cost reduction and operating leverage from the 35% increase in revenue. Over the last year and a half, our focus has been to reduce product costs and reduce lab operations expenses to drive margins higher. Recall that just a few quarters ago, our gross margin was only 19%. So we are making very good progress.
Christopher Hall: For example, a female patient from the Northeast receiving therapy for breast cancer tested positive with our next personal test. Her position saw low traces of cancer in the ultra-sensitive range for over several months, and luckily for this patient, the detected levels trended downwards until the patient's cancer finally became undetectable. Continued monitoring can potentially help inform taking patients like this off-therapy in the future and provide reassurance to both the doctor and the patient.
Speaker Change: In addition, we recognize $0.1 million of clinical revenue from our next DX tumor profiling test.
Aaron Tachibana: Also, we had over four percentage points of unreimbursed clinical test costs during the second quarter. Otherwise, gross margins would have been closer to 40%. One of our top goals is to continue expanding gross margin. As we go forward, we expect margins to continuously improve with scale, although there could be some quarter to quarter variability due to fluctuations in volume, unreimbursed clinical test costs, and other factors. Operating expenses were $24.9 million in the second quarter compared with $30.1 million for the same period of the prior year. Most of the year-over-year decrease was attributed to actions taken to reduce headcount in 2023.
Speaker Change: Gross margin expanded to 35.6% for the second quarter compared with 28.7% for the same period of the prior year.
Aaron Tachibana: The year-over-year increase of 6.9 percentage points was primarily due to product cost reduction and operating leverage from the 35 percent increase in revenue. Over the last year and a half, our focus has been to reduce the product costs and to reduce lab operations expenses to drive margins higher. Recall that just a few quarters ago, our gross margin was only 19 percent, so we are making very good progress. Also, we had over 4 percentage points of unreinversed clinical test costs during the second quarter; otherwise, gross margins would have been closer to 40 percent. One of our top goals is to continue expanding gross margin.
Speaker Change: The year-over-year increase of 6.9 percentage points was primarily due to product cost reduction and operating leverage from the 35% increase in revenue.
Speaker Change: over the last year and a half our focus has been to reduce the product costs and to reduce lab operations expenses to drive margins higher
Christopher Hall: Moving to our second pillar, we're focused on building and publishing clinical evidence to gain reimbursement and continue to work with many of the top fault leaders around the world. In previous calls and during the ASCO webinar, we've talked about the importance of our work with two of the leading cancer centers in Europe, Roe, Marston and breast cancer, and Valde Hebron for an immunotherapy monitoring. Both of these collaborators have provided access to studies that are broad and comprehensive.
Speaker Change: Recall that just a few quarters ago our gross margin was only 19% so we are making very good progress.
Aaron Tachibana: Also, we had over four percentage points of unreimbursed clinical test costs during the second quarter. Otherwise, gross margins would have been closer to 40%. The net loss for the second quarter was $12.8 million compared with $24 million for the same period of the prior year. The second quarter net loss included a $3 million non-cash gain related to fair value accounting of the outstanding warrants issued to TEPA.
Speaker Change: Also, we had over four percentage points of unreimbursed clinical test costs during the second quarter. Otherwise, gross margins would have been closer to 40 percent.
Christopher Hall: In the case of Roe, Marston and the Institute of Cancer Research in the UK, which are one of the leading global institutions at breast cancer, the study included patients across the major breast cancer subtypes, including HR, her positive or two positive and triple-negative breast cancer in patients, were followed in the study for a medium of six years. The study results were highlighted at ASCO during a podium presentation and the results were compelling.
Speaker Change: One of our top goals is to continue expanding gross margin. As we go forward, we expect margins to continuously improve with scale, although there could be some quarter-to-quarter variability due to fluctuations in volume, unreimbursed clinical test costs, and other factors.
Aaron Tachibana: As we go forward, we expect margins to continuously improve with scale, although there could be some quarter-to-quarter variability due to fluctuations in volume, unreinversed clinical test costs, and other factors. Operating expenses were $24.9 million in the second quarter compared to $30.1 million for the same period of the prior year. Most of the year-over-year decrease was attributed to actions taken to reduce headcount in 2023. R&D expense was $13.9 million in the second quarter compared to $17.9 million for the same period last year, and SG&A expense was $11.9 million compared to $12.1 million for the same period last year.
Speaker Change: Operating expenses were $24.9 million in the second quarter, compared with $30.1 million for the same period of the prior year.
Christopher Hall: Next, personal detected early stage breast cancer, a medium of 15 months before imaging scans for patients. For Valde Hebron or VHIO, the work is in pan cancer and included greater than 120 patients across 18 different cancer subtypes. The study shows that next personal could be potentially used to predict immunotherapy response for patients. Similar to what we were seeing with our breast cancer studies, our test is detecting traces of cancer well ahead of imaging scans.
Aaron Tachibana: R&D expense was $13 million in the second quarter compared with $17.9 million for the same period last year. And SG&A expense was $11.9 million compared with $12.1 million for the same period last year. The net loss for the second quarter was $12.8 million compared to $24 million for the same period of the prior year. The second quarter net loss included a $3 million non-cash gain related to fair value accounting of the outstanding warrants issued to TEPCO.
Speaker Change: Most of the year-over-year decrease was attributed to actions taken to reduce headcount in 2023.
Speaker Change: R&D expense was $13 million in the second quarter, compared with $17.9 million for the same period last year. And SG&A expense was $11.9 million, compared with $12.1 million for the same period last year.
Aaron Tachibana: Net loss for the second quarter was $12.8 million compared to $24 million for the same period of the prior year. The second quarter net loss included a $3 million non-cash gain related to fair value accounting of the outstanding warrants issued to TEPIS. This non-standard income was a result of the decrease in fair market value of the warrants at June 30, 2024, compared with the fair market value at the end of last quarter. And for clarification, the accounting implications for the warrants have no bearing on the cash value they are exercised in the future. Now under the balance sheet, we finished the second quarter with a strong balance sheet with cash and short-term investments of $87 million.
Speaker Change: Net loss for the second quarter was $12.8 million compared to $24 million for the same period of the prior year. The second quarter net loss included a $3 million non-cash gain related to fair value accounting of the outstanding warrants issued to Tempest.
Christopher Hall: These were all Marston results in the VHIO studies from immunotherapy monitoring, joining our Tracer X working lung cancer to form the backbone of our efforts to gain Medicare Reimbursement. Investigators in all three of these studies, Roe Marston, VHIO and Tracer X are working to submit manuscripts to peer review journals, which is a key step for us ultimately to submit for Medicare reimbursement. Once those manuscripts are published, we can then submit the individual dossiers for each of the indications to Medicare.
Aaron Tachibana: This nonstandard income was a result of the decrease in the fair market value of the warrants at June 30, 2024, compared with the fair market value at the end of the previous quarter. And for clarification, the accounting implications for the warrants have no bearing on the cash value they are exercised for in the case.
Speaker Change: This non-standard income was a result of the decrease in fair market value of the warrants at June 30, 2024, compared with the fair market value at the end of last quarter.
Speaker Change: And for clarification, the accounting implications for the warrants have no bearing on the cash value they are exercised in the future.
Aaron Tachibana: Now on to the balance sheet. We finished the second quarter with a strong balance sheet, with cash and short-term investments of $87 million. During the quarter, we used $8.4 million to fund operations, and we have more than one and a half years of cash on the balance sheet, which is expected to last through the first quarter of 2026. Now I'd like to turn to guidance.
Aaron Tachibana: We finished the second quarter with a strong balance sheet, with cash and short-term investments of $87 million. During the quarter, we used $8.4 million to fund operations, and we have more than one and a half years of cash on the balance sheet, which is expected to last through the first quarter of 2026. For the third quarter of 2024, we expect total company revenue in the range of $21 to $22 million, revenue from pharmaceutical tests, enterprise sales, and other customers in the range of $17 to $18 million, and revenue from population sequencing of approximately $4 million.
Speaker Change: Now onto the balance sheet. We finished the second quarter with a strong balance sheet with cash and short-term investments of $87 million.
Aaron Tachibana: During the quarter, we used 8.4 million to fund operations, and we have more than 1.5 years of cash on the balance sheet, which is expected to last through the first quarter of 2026.
Christopher Hall: There were two other datasets at ASCO that highlighted next personal that are also worth noting. One was the study with Dana Farber for her two positive patients that showed next personal was correlated with outcomes and patients receiving neo-adjuvant therapy. Neo-adjuvant therapy is given to these patients before surgery to try to shrink the tumor before the cancer is removed, and a second study, this one with Duke, deepened the data indicating next personal could be used to predict immunotherapy response.
Speaker Change: During the quarter, we used $8.4 million to fund operations, and we have more than one-and-a-half years of cash on the balance sheet, which is expected to last through the first quarter of 2026.
Aaron Tachibana: Now I'd like to turn to guidance. For the third quarter of 2024, we expect total company revenue in the range of $21 to $22 million, revenue performance tests, enterprise sales, and other customers in the range of $17 to $18 million, and revenue from population sequencing of approximately $4 million. Service. And for the four-year, we increased our guidance and now expect total company revenue in the range of 79 to 81 billion, and increased from our prior guidance of 76 to 78 million. Revenue from farm and test enterprise sales and other customers in the range of 71 to 73 million, and increased from our prior guidance of 68 to 70 million. This estimate includes revenue from Nutera of approximately 21 to 22 million dollars, of which 5 to 6 million is expected in the second half of the year.
Aaron Tachibana: For the third quarter of 2024, we expect total company revenue in the range of $21 to $22 million, revenue from pharmaceutical tests, enterprise sales, and other customers in the range of $17 to $18 million, and revenue from Population Sequencing of approximately $4 million. And for the full year, we increased our guidance and now expect total company revenue in the range of $79 to $81 billion, an increase from our prior guidance of 76 to 70.
Speaker Change: Now I'd like to turn to guidance.
Speaker Change: For the third quarter of 2024, we expect total company revenue in the range of $21-$22 million, revenue from pharma tests, enterprise sales, and other customers in the range of $17-$18 million.
Speaker Change: and revenue from population sequencing of approximately $4 million.
Christopher Hall: The third pillar of our next personal strategy is to leverage our bioformer relationships to drive the use of next personal and clinical trials. We're engaged with the most, excuse me, with most of the world's top bioformer companies and have continued to generate excitement around our next personal test, most recently from discussions at ASCO. Customers want to need an ultra-sensitive approach to ensure that most appropriate patients enter into clinical trials. For example, we believe that our ultra-sensitive aspect means that patients testing negative are much less likely to have a recurrence.
Aaron Tachibana: And for the full year, we increased our guidance and now expect total company revenue in the range of $79 to $81 billion, an increase from our prior guidance of 76 to 78. Revenue from pharma tests, enterprise sales, and other customers in the range of $71 to $73 million. And cash usage is expected to be approximately $60 million, a decrease from our prior guidance of $62 million.
Speaker Change: And for the full year, we increased our guidance and now expect total company revenue in the range of $79 to $81 million, an increase from our prior guidance of $76 to $78 million.
Aaron Tachibana: Revenue from pharma tests, enterprise sales, and other customers in the range of $71 to $73 million, an increase from our prior guidance of $68 to $70 million, and this estimate includes revenue from NTERA of approximately $21 to $22 million, of which $5 to $6 million is expected in the second half of the year, population sequencing revenue of approximately $8 million, a non-GAAP net loss of approximately $75 million, a decrease from our prior guidance of We look forward to updating you on our progress during the next conference call in a few months. And with that, I will turn the call back over to the operator to begin the Q&A session. Operator.
Speaker Change: Revenue from pharma tests, enterprise sales, and other customers in the range of $71 to $73 million.
Speaker Change: An increase from our prior guidance of $68-70 million, and this estimate includes revenue from NTERA of approximately $21-22 million, of which $5-6 million is expected in the second half of the year.
Christopher Hall: Our bioformer customers can then expect that these patients are less likely to benefit from a therapeutic intervention. Holding out the promise that next personal would be an excellent approach to optimize bioformer trials. We have booked millions of dollars of revenue from bioformer customers from emerging projects today and expect the growth to accelerate.
Aaron Tachibana: Population sequencing revenue to the approximately 8 million, non-gap net loss of approximately 75 million, a decrease from our prior guidance of 77 million, and exclude any income for expense related to the outstanding warrants issued to Tempest, and cash usage is expected to be approximately 60 million, a decrease from our prior guidance of 62 million dollars.
Speaker Change: Population Sequencing Revenue to be approximately $8 million.
Speaker Change: non-GAAP net loss of approximately 75 million, a decrease from our prior guidance of 77 million, and exclude any income or expense related to the outstanding warrants issued to Tempest.
Christopher Hall: Now move on to the fourth and final pillar. Visualize the next personal in the clinical market using a partner-centered model.
Speaker Change: And cash usage is expected to be approximately $60 million, a decrease from our prior guidance of $62 million.
Operator: You look forward to updating you on our progress during the next conference call in a few months, and with that, I will turn the call back over to the operator that began the Q&A session.
Aaron Tachibana: We look forward to updating you on our progress during the next conference call in a few months. And with that, I will turn the call back over to the operator to begin the Q&A session.
Christopher Hall: In December, we announced our key partnership with Tempest to work commercialize next personal in the clinics with oncologists. And recently, Tempest announced the launch of our products to their customers. To quickly review, we expect to leverage Tempest's 200 plus salespeople channel to co-commercialize next personal and accelerate growth. Personals will be responsible for processing samples in our lab, obtaining reimbursement, invoicing health insurance payers, and patients under the arrangement, while paying Tempest fair market value for the commercial services they provide to us.
Speaker Change: We look forward to updating you on our progress during the next conference call in a few months. And with that, I will turn the call back over to the operator to begin the Q&A session. Operator?
Operator: Operator? Thank you.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone, and you will hear a prompt that your hand has been raised. Similarly, should you wish to decline from the polling process, please press the star followed by the number zero. If you are using a speakerphone, please lift the handset before pressing any key. One moment, please, for your first question.
Operator: Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star, followed by the number one on your touchstone phone, and you will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star, followed by the number two. If you are using a speaker phone, please lift the handset before pressing any keys. One moment, please, for your first question.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone, and you will hear a prompt that your hand has been raised. Similarly, should you wish to decline from the polling process, please press the star followed by the number zero. If you are using a speakerphone, please lift the handset before pressing any key. One moment, please, for your first question. Our first question is coming from Yuko Oku of Morgan.
Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone and you will hear a prompt that your hand has been raised.
Operator: Should you wish to decline from the polling process, please press the star followed by the number 2.
Christopher Hall: Overall, the deal is worth approximately 30 million for personnel should all milestone payments be triggered and if Tempest fully exercises their awards. We expect this to allow us to ramp up commercial efforts quickly with minimal additional cash investments. We're now on the Tempest requisition and we're processing samples sent to our lab. The goal for the balance of the year is to purposely grow our efforts together, learning how to work seamlessly as partners, integrating our business systems, and refining our message to oncologists.
Speaker Change: If you are using a speakerphone, please lift the handset before pressing any keys.
Speaker Change: One moment, please, for your first question.
Madison Patricia: Our first question is coming from Yoku, OPPO, from Morgan Stanley. Hi, this is Madison on for You Go. How are you guys? I'm out of the same address. Okay, congrats on the corner, and thanks for taking the question. I have a two part here, just a first one. I was wondering, should Moderna's PCV eventually secure FDA approval? I was wondering if you could remind us what the potential upside could be on that, and are you specced into the product? Or is it possible that another sequencing vendor could also start to sequence for Moderna once approved?
Madison Patricia: Hi, this is Madison. I'm for Yuko.
Speaker Change: Our first question is coming from Yuko Oku from Morgan Stanley .
Speaker Change: Hi, this is Madison. I'm for Yuko. How are you guys?
Madison Patricia: How are you guys? I'm happy to see you, Madison. Congratulations on the quarter and thanks for taking the question. I have a two-parter here.
Madison: I'm Madison. Congratulations on the quarter and thanks for taking the question. I have a two-parter here.
Speaker Change: I'm happy to say it matters.
Speaker Change: ok got in the quarter and thanks for taking the question i have a two part here just first one i was wondering
Madison Patricia: Just the first one, I was wondering... Should Moderna's PCV eventually secure FDA approval, I was just wondering if you could remind us what the potential upside could be on that. And are you spec'd into the product, or is it possible that another sequencing vendor could also start to sequence for Moderna once approved?
Madison: Just the first one, I was wondering... Should Moderna's PCV eventually secure FDA approval, I was just wondering if you could remind us what the potential upside could be on that. And are you spec'd into the product, or is it possible that another sequencing vendor could also start to sequence for Moderna once approved?
Christopher Hall: This way, we're set to drive accelerated growth together on the backside of reimbursement approval. The Tempest relationship is working extremely well today, our cultures, and our teams work well together, and we're confident that we're creating something great for doctors, patients, and payers. While we made strides with our first growth engine, our winning MRD strategy to establish next person with a leading MRD test. We've also made progress with our second growth engine leveraging our amino-ID next platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies.
Madison: Should Moderna's PCV eventually secure FDA approval? I was wondering if you could remind us what the potential upside could be on that, and are you spec'd into the product, or is it possible that another sequencing vendor could also start to sequence for Moderna once approved?
Chris Hall: Hi, Madison. Thanks for the question. In terms of the Moderna relationship, we are ecstatic about how this has been operating. Again, we've been partners with Moderna since 2016 to 2017.
Chris Hall: Hi Madison, thanks for the question. In terms of the Moderna relationship, we are ecstatic about how this has been operating. Again, we've been partners with Moderna from 2016 to 2017. In terms of where this goes upon commercialization, that's something for Moderna to talk about. We're not really talking too much about the upside or the opportunity.
Speaker Change: Hi Madison, thanks for the question. In terms of the Moderna relationship, so we are ecstatic about how this has been operating. Again, we've been partners with Moderna since 2016 to 2017. In terms of
Christopher Hall: Our biopharma business grew 117 percent year over year, and we had solid performance across our product portfolio. Customers primarily use our amino-ID next platform in two ways. First, they leverage our platform to power translational research and find new biomarkers and insights that can enable their drug discovery efforts. Second, companies in the personalized cancer vaccine or the PCD market use our platform to create a molecular fingerprint of a patient's tumor to develop personalized therapy.
Chris Hall: In terms of where this goes upon commercialization, that's something for Moderna to talk about. We're not really talking too much about the upside or the opportunity. We just know that it is a huge opportunity for us. We're excited about it, but that should come from the Moderna folks to talk about.
Speaker Change: Where this goes upon commercialization, that's something for Moderna to talk about. We're not really talking too much about the upside or the opportunity.
Speaker Change: we just know that it is a huge opportunity force we're excited about it but that should come from the majority folks to talk about in terms of the offering
Chris Hall: We just know that it is a huge opportunity for us. We're excited about it, but that should come from the Moderna folks to talk about. In terms of the offering, again, today's samples are taken from patients, and the patient samples are sent to Personalis. We profile them, and we send back this rich, informative set of data to Moderna so they can then customize a vaccine or a therapy for that individual patient.
Chris Hall: In terms of the offering, so again, today samples are taken from patients, and the patient samples are sent to personnel as we profile them. And we send back this rich, informative set of data back to Moderna, so they can then customize a vaccine or therapy for that individual patient. In terms of, again, the relationship, you know, we believe we have a very, very solid relationship and, you know, maternal values are platform. So, in terms of the longer term prospects, you know, we feel very confident about going into the future.
Speaker Change: So again, today's samples are taken from patients, and the patient samples are sent to Personalis. We profile them, and we send back this rich, informative set of data back to Moderna so they can then customize a vaccine or a therapy for that individual patient.
Christopher Hall: Therapy. We previously told you about our partnership with Moderna in which Moderna is utilizing our platform in their M or an A cancer program. Moderna and its partner, Merkern, rolling patients, and our collaboration with Moderna is important for our revenue for us in 2024 and 2025. We have several other partners that work in the space as well.
Chris Hall: In terms of, again, the relationship, you know, we believe we have a very, very solid relationship, you know, Moderna values our platform. So in terms of the longer term prospects, you know, we feel very confident about this going into the
Speaker Change: In terms of, again, the relationship, you know, we believe we have a very, very solid relationship, and
Unknown Executive: you know, Moderna values our platform. So in terms of the longer term prospects, you know, we feel very confident about this going into the
Christopher Hall: The third engine of our growth is growing our personalism side approach as we service enterprise customers. In these relationships, partners adopt our platforms and technologies to power their solutions. For example, NETARA has leveraged our exome platform as a part of their MRD product health and scale while they work to build and house capabilities. As planned, they've reached a point where they can now run the product in their lab and we expect to wind down our work with NETARA by the end of 2024 and we have no intention to extend the current commercial arrangement.
Unknown Executive: adjaternof values our platform so in terms of the longer term prospects we feel very confident about going into the uture
Madison Patricia: Got it. Okay, let's get to here.
Chris Hall: Got it. Okay, that's good to hear. And then, with Tempest launching their own MRD solution, I was wondering how you make sure that they are incentivized to also market next generation employees, like what is the kind of incentive structure they put in place for the product so that they get an equal commercial push from Salesforce. Yeah, no, great, great question. I mean, first of all, just backing up.
Chris Hall: And then, just on with Tempest launching their own MRD solution, I was wondering how you make sure that they are incentivized to also market the next person out personal. Like, what is the kind of incentive structure there put in place for the product so that they get an equal commercial push from the sales force? Yeah, no, great question. I mean, first of all, just backing up while we're on the Tempest requisition, like we're growing the number of Tempest sales reps that are selling the product over time aggressively to be able to get the volume. So, you know, it's like right now we're, we're starting the journey and moving it up slowly.
Madison: Just on with Tempest launching their own MRD solution, I was wondering how you make sure that they are incentivized to also market next generation employees, like what is the kind of incentive structure they're put in place for the product so that they get an equal commercial push from Salesforce.
Madison: got it okay let's good to hear and then
Madison: Just on with Tempest launching their own MRD solution, I was wondering,
Madison: How you make sure that they are incentivized to also market next personnel, like, what is the kind of incentive structure they're put in place for the product so that they get an equal commercial push from the sales force?
Christopher Hall: With other strategic parts of our business accelerating quickly, PCV, BioFarm MRD projects, and our clinical diagnostic business, the additional capacity will shift to support those critical parts of our business. I should also know we're having other discussions exploring scaling up enterprise work in 2025.
Chris Hall: Yeah, no, great, great question. I mean, first of all, just backing up, while we're on the Tempest requisition, like we're growing the number of Tempest sales reps that are selling the product over time aggressively to be able to gain volume. So, you know, it's like right now we're just starting the journey and moving it up slowly.
Speaker Change: Yeah, no, great, great question. I mean, first of all, just backing up, while we're on the Tempest requisition, like we're, we're growing the number of Tempest sales reps that are selling the product over time aggressively to be able to gain some volume. So, you know, it's like right now we're, we're starting the journey and moving it up slowly.
Christopher Hall: A second important enterprise relationship is the VA. The VA utilizes our whole genome sequencing capabilities to power the million veteran program, a national research program looking at how genes and lifestyle affect health and veterans. We've helped power this program with the VA for over 10 years. The VA informs us this quarter that they plan to renew the contract another year and we expect to receive a new purchase order by the end of September.
Chris Hall: Tempest's product is a blood base. It's not, it's not, it's not the same type of product. It's a tumor naive product. Ours is a tumor normal product. They positioned it as a colorectal cancer were positioned at long breast and IO therapy monitoring.
Chris Hall: Tempest's product is a, is a blood base. It's not, it's not, it's not the same type of product. It's a tumor naive product or it's a tumor normal product. They've positioned it in a colorectal cancer or persistent it on breast and IO therapy monitoring. So products are position will be differently. And I think it's actually really, really great to have both products under the same roof. Because the truth is, for some patients, you're not going to have the access to the, you're not going to have access to the tissue and you're just going to have access to the blood.
Speaker Change: Tempest's product is a blood base. It's not the same type of product. It's a tumor-naive product. Ours is a tumor-normal product. They positioned it in colorectal cancer. We're positioned at lung, breast, and IO therapy monitoring. So the products are positioned a little bit differently. And I think it's actually really, really great to have both products under the same roof.
Chris Hall: So products are positioned a little bit differently, and I think it's actually really, really great to have both products under the same roof. Because the truth is, for some patients, you're not going to have access to the tissue, and you're just going to have access to the blood.
Speaker Change: Because the truth is, for some patients, you're not going to have access to the tissue.
Christopher Hall: Before I turn it over to Aaron, I have a couple of important corporate updates. First, we recently completed an agreement with myriad genetics to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease or MRD. Both companies value tumor-informed approaches for cancer patients and have developed deep foundational patent estates in the field and each sees the benefits of an ultra-sensitive approach as key to making MRD testing to standard of care.
Chris Hall: And so I think if you just step back and think about it, Tempest is uniquely the company that stitched together both a tumor naive and a tumor normal approach under one roof. And they're really set up to accelerate growth in the marketplace with a comprehensive offering. So we'd actually think the two products work together really well, and I think that's how Tempest is viewing it, and it's set up nicely. Got it. That's good to hear. Thanks so much for your time.
Chris Hall: And so I think, I think if you just step back and think about it, Tempest is uniquely the company that stitched together both a tumor naive and a tumor and a tumor normal approach, you know, approach under one roof and they really set up to accelerate growth in the marketplace with a comprehensive offering. So we actually think the two products work together really well, and I think that's how Tempest is viewing it and in a set up nicely.
Madison: and you're just going to have access to the blood. So I think if you just step back and think about it, tempus.
Speaker Change: is uniquely the company that stitched together both a tumor-naive and a tumor-normal approach under one roof. And they're really set up to...
Speaker Change: to accelerate growth in the marketplace with a comprehensive offering. So we actually think the two products work together really well, and I think that's how Tempest is viewing it, and it's set up nicely.
Christopher Hall: The agreement we entered into helps solidify our each company's freedom to operate in the MRD market and broadens access to the benefits of MRD testing for cancer patients. Personalis and MRD and myriad are each pioneering tumor-informed genome-scale approaches to power ultra-sensitive MRD tests enabling cancer recurrent detection early or in more refined therapy monitoring than alternative approaches.
Madison Patricia: Got it. That's good to hear.
Madison Patricia: Thanks so much for the time. Thanks, Madison.
Speaker Change: that's good to hear thanks so much for the time
Vivian: Next question on the line will be coming from Mark Nasserow from BDIG.
Chris Hall: The next question on the line will be from Mark Massaro from BDIG.
Madison: Next question on the line will be coming from Mark Massaro from BDIG.
Vivian: Hey guys, this is Vivian on Cromark. Thanks for taking the questions. I just want to touch on next personal reimbursement. I just want to find this kind of thinking about a potential crosswalk or gap, so there for pricing. Just the way you think that will land and any potential upside as it relates to potential ADLT status.
Vidyun Bais: Hey guys, this is Vidyun.
Vidyun: Hey, guys, this is Vidyun from AHRQ. Thanks for taking the questions. So just want to touch on next personal reimbursement. Just remind us how you're thinking about a potential crosswalk or gap fill there for pricing, just where you think that will land and any potential upside as it relates to potential ADLT status. Thanks.
Vidyun: Hey, guys. This is Vidyun. I'm from AHRQ. Thanks for taking the questions. So, I just wanted to touch on next personal reimbursement. Just remind us how you're thinking about a potential crosswalk or gap fill there for pricing. Just where you think that will land and any potential upside as it relates to potential ADLT status. Thanks.
Christopher Hall: Additionally, we settled our litigation with Forsyte which resulted in us granting them a license to our MRD patents.
Christopher Hall: This is a great outcome for personalises. One, our IP that we've developed over many years is valuable. We were able to show that and we'll be paid royalties moving forward. Secondly, we can focus on running our business and putting litigation costs behind this.
Christopher Hall: Both the cross-license agreement with myriad and the settlement should give investors confidence in the value of our IP, the strength of its protection and our ability to create value from it.
Chris Hall: Thanks. Yeah, great question. I mean, I, we build all of our economic models. I mean, we get similar to what other players have been reimbursed in the marketplace, but there's a couple, you know, different shots on goal. To drive that higher one is that the testman of itself is a more resource intensive test than an exo-based test. Medicare reimburses based on that. So we think that's one, one way just fundamentally that the test should be priced higher because it's a more resource-intensive test to run, which is how these tests ultimately are priced. And secondarily, there is a shot to get ADLT status, so we're working on management.
Chris Hall: Yeah, great question. I mean, we build all of our economic models assuming we get something similar to what other players have been reimbursed in the marketplace. But there's a couple of different shots at goal to drive that higher. One is that the test, in and of itself, is a more resource-intensive test than an exome-based test. Medicare reimburses based on that. So we think that's one way, just fundamentally, that the test should be priced higher because it's a more resource-intensive test to run, which is how these tests ultimately are priced.
Vidyun Bais: I'm from AHRQ. Thanks for taking the questions. So I just want to touch on next personal reimbursement. Just remind us how you're thinking about a potential crosswalk or gap fill there for pricing, just where you think that will land and any potential upside as it relates to potential ADLT status. Thanks. Yeah, great question.
Speaker Change: Yeah, great question. I mean, I, we build all of our economic models, assuming we get similar to what other players have been reimbursed in the marketplace. But there's a couple, you know, different shots on goal to drive that higher. One is that the test in and of itself is
Aaron Tachibana: With that, I'll now turn it over to Aaron to review our financial results. Thank you, Chris. Total company revenue for the second quarter, 2024, was $22.6 million and increased by 35% compared with $16.7 million for the same period of the prior year. The increase in revenue was driven by higher volume from bioforma and personalized cancer vaccine customers, which was partially offset by declines from the BAMV page. Bioforma revenue grew 117 percent compared to the same period last year, and the growth was primarily from amino ID next.
Speaker Change: is a more resource-intensive test than an exome-based test. Medicare reimburses based on that, so we think that's one one way just fundamentally that the test should be priced higher because it's a more resource-intensive test to run which is how these tests ultimately are priced.
Chris Hall: And secondarily, there is a shot to get ADLT status, so we're working on managing that. But the expectation we've set is that we're tracking to have gross margins greater than 60%. Even if we don't achieve any of those things, we're set up well, and the Tempest relationship brings sales and marketing costs down to that 20 to 25% range. And so we built the economics from there. And then the rest of it will just drive the number, be more lucrative if we're able to achieve higher reimbursement.
Chris Hall: But the expectation we've set is that we're tracking to have gross margins greater than 60%, even if we don't achieve any of those things. We're set up well, and the tempest relationship brings sales and marketing costs down in that 20 to 25% raise. And so we built the economics from there, and then the rest of it will just drive the numbers to be a more innovative before we're able to achieve higher reimbursement.
Speaker Change: And secondarily, there is a shot to get ADLT status, so we're working on managing that.
Unknown Executive: But the expectation we've set is that we're tracking to have gross margins greater than 60%. Even if we don't achieve any of those things, we're set up well. And the Tempest relationship brings sales and marketing costs down in that 20 to 25% range. And so we built the economics from there. And then the rest of it will just drive the numbers.
Unknown Executive: But the expectation we've set is that we're tracking to have gross margins greater than 60% even if we don't achieve any of those things.
Unknown Executive: We're set up well, and the Tempest relationship brings sales and marketing costs down in that 20 to 25% range, and so we built the economics from there, and then the rest of it will just drive the numbers to be more lucrative if we're able to achieve higher reimburses.
Aaron Tachibana: In addition, we recognized 0.1 million of clinical revenue from our next DX tumor profiling test. Growth margin expanded to 35.6 percent for the second quarter compared to 28.7 percent for the same period at the prior year. The year-over-year increase of 6.9 percentage points was primarily due to product cost reduction and operating leverage from the 35 percent increase in revenue. Over the last year and a half, our focus has been to reduce the product costs and to reduce lab operations expenses to drive margins higher.
Vivian: Thank you so much for the color there. And I'm just going to follow up; Moderna has sort of exceeded expectations.
Vidyun Bais: Perfect. Thanks so much for the color there.
Vidyun: Perfect. Thanks so much for the color there.
Vidyun Bais: And then just to follow up on Moderna sort of exceeding expectations. Can you just remind us? I think they've expanded the number of indications they're looking at on PCB. So maybe just touch on that. And then also your longer-term outlook on the pharma side of the business. Thanks.
Unknown Executive: And then just to follow up on Moderna sort of exceeding expectations. Can you just remind us? I think they've expanded the number of indications they're looking at on PCB. So maybe just touch on that. And then also your longer-term outlook on the pharma side of the business. Thank you.
Unknown Executive: Perfect. Thanks so much for the color there. And then just to follow up on Moderna has sort of exceeded expectations. Can you just remind us, I think they've expanded the number of indications they're looking at on PCV, so maybe just touch on that and then also your longer-term outlook on the pharma side of the business. Thanks.
Chris Hall: Can you just remind us, I think they've expanded the number of indications they're looking at on PCV. So maybe just touch on that and then also your longer term outlook on the farm aside from the business. Thanks. Sure. Thanks, Vidyun. So, in terms of the Moderna relationship, remember, they're in the phase three clinical trial right now with melanoma patients. They had three successes in phase two in terms of the volume that we're seeing today. A lot of that is because of the phase three trial. So the number of patients in the phase three trial significantly outpaced what you'll see in phase one or phase two.
Chris Hall: Sure, sure. Thanks, Vivian. So in terms of the Moderna relationship...
Speaker Change: Sure, sure. Thanks, Vivian. So, in terms of the Moderna relationship,
Chris Hall: Remember, they're in a phase three clinical trial right now with melanoma patients. They had great success in phase two. In terms of the volume that we're seeing today, a lot of that is because of the phase three trial. So the number of patients in the phase three trial significantly outpaces what you'll see in phase one or phase two. In terms of other cancer types, yes, they are focused on additional cancer types as well, right, but in terms of, you know, talking too much in terms of specifics, that's something, again, that should come from them, but they are working on others as well. Great. Thanks so much for taking the time to take
Aaron Tachibana: Recall that just a few quarters ago, our gross margin was only 19 percent, so we are making very good progress. Also, we had over 4 percentage points of unreinversed clinical test costs during the second quarter, otherwise gross margins would have been closer to 40 percent. One of our top goals is to continue expanding gross margin. As we go forward, we expect margins to continuously improve with scale, although there could be some quarter to quarter variability due to fluctuations in volume, unreinversed clinical test costs, and other factors.
Speaker Change: Remember, they're in the Phase 3 clinical trial right now with melanoma patients. They had treat success in Phase 2.
Speaker Change: In terms of the volume that we're seeing today, a lot of that is because of the Phase 3 trial. So the number of patients in the Phase 3 trial significantly outpaced what you'll see in Phase 1 or Phase 2. In terms of other cancer types...
Vivian: In terms of other cancer types, yes, they are focused on additional cancer types as well, right. But in terms of, you know, talking too much in terms of specifics, that something again, that should come from them, but they are working on others as well. Great.
Unknown Executive: Yes, they are focused on additional cancer types as well, right, but in terms of, you know, talking too much in terms of specifics, that's something, again, that should come from them, but they are working on others as well. Great. Thanks so much for taking the time.
Unknown Executive: Yes, they are focused on additional cancer types as well, right? But in terms of, you know, talking too much in terms of specifics, that's something again that should come from them, but they are working on others as well.
Vidyun Bais: Great. Thanks so much for taking the question.
Unknown Executive: Great. Thanks so much for taking the question.
Vivian: Thanks so much for taking the questions. Thank you.
Aaron Tachibana: Operating expenses were $24.9 million in the second quarter compared to $30.1 million for the same period of the prior year. Most of the year-over-year decrease was attributed to actions taken to reduce headcount in 2023. R&D expense was $13.9 million in the second quarter compared to $17.9 million for the same period last year, and SGNA expense was $11.9 million compared to $12.1 million for the same period last year. Net loss for the second quarter was $12.8 million compared to $24 million for the same period of the prior year.
Unknown Executive: Great. Thanks so much for taking the questions.
Speaker Change: Thank you.
Thomas Flaten: The next question will be coming from Thomas Flaten from Lake Street.
Thomas Flaten: The next question will be coming from Thomas Flaten from Lake Street.
Thomas Clayton: Next question will be coming from Thomas Clayton from Lake Street. You're afternoon, guys. I appreciate you taking the questions. Chris, you mentioned in an earlier response, you know, kind of gating the Tempest efforts here in the near term. Can you talk to us a little bit about exactly how you're going to do that, you know, how many reps are you going to bring on and how are you going to pace those reps. So you don't overburden the system with too much volume when you're not getting paid. Any color that will be super helpful. Yeah, yeah, so they we've started out with a small number of tempest reps that are actually in a trained and marketing and talking about the product, and the plan is to grow that over time.
Thomas Flaten: Next question will be coming from Thomas Flaten from Lake Street.
Thomas Flaten: Good afternoon, guys. I appreciate you taking the questions. Chris, you mentioned in an earlier response that you're kind of gating the Tempest efforts here in the near term. Can you talk to us a little bit about exactly how you're going to do that? You know, how many reps are you going to bring on? And how are you going to pace those reps? So you don't overburden the system with too much volume when you're not getting paid? Any color would be super helpful.
Thomas Flaten: Good afternoon, guys. I appreciate you taking the questions. Chris, you mentioned in an earlier response that you are kind of gating the Tempest efforts here in the near term.
Thomas Flaten: Good afternoon, guys. I appreciate you taking the questions. Chris, you mentioned in an earlier response...
Thomas Flaten: You know kind of gating the Tempest efforts here in the near term Can you talk to us a little bit about exactly how you're going to do that? You know how many reps are you going to bring bring on and how are you going to pace those reps? So you don't overburden the system with too much volume when you're not getting paid any color that will be super helpful
Thomas Flaten: Can you talk to us a little bit about exactly how you're going to do that? You know, how many reps are you going to bring on? And how are you going to pace those reps so you don't overburden the system with too much volume when you're not getting paid? Any color would be super helpful.
Aaron Tachibana: The second quarter net loss included a $3 million non-cash gain related to fair value accounting of the outstanding warrants issued to TEPIS. This non-standard income was a result of the decrease in fair market value of the warrants at June 30, 2024, compared with the fair market value at the end of last quarter. And for clarification, the accounting implications for the warrants have no bearing on the cash value they are exercised in the future.
Unknown Executive: Yeah, yeah, so we've started out with a small number of Tempest reps that are actually trained in marketing and talking about the product, and the plan is to grow that over time. So it's a graduated approach that enlarges the resources put into the sales process as we go. If you remember, there are actually some volume gates built into the agreement so that Tempest has agreed not to exceed certain numbers on a year-to-year basis.
Chris Hall: Yeah, yeah, so we've started out with a small number of Tempest reps that are actually trained in marketing and talking about the product. The plan is to grow that over time, so it's a graduated approach that enlarges the resources put into the sales process as we go. If you remember, there are actually some volume gates built into the agreement so that Tempest has agreed not to exceed certain numbers on a year-to-year basis.
Chris Hall: Yeah, yeah. So they we've started.
Unknown Executive: Yeah, yeah, so they we've started out.
Unknown Executive: Yeah, yeah, so they, we've started out, um...
Unknown Executive: With with a small number of Tempest reps that are actually, you know, trained in marketing and talking about the product And the plan is to grow that over time. So it's a
Chris Hall: So it's a to graduate it or you know, approach that's that enlarges the resources put at the sales process as we go. So if you remember, there's actually some volume gates also build and agreement. So the tempest is agreed not to exceed certain numbers on a year-to-year basis, and we've all been sort of aligned around that. So the part of the challenge here is how to show increasing clinical traction with doctors and investigators so that they're using the product and they feel comfortable at the same point time managing the burn rate and running those tests.
Unknown Executive: To graduate it or, you know, approach that enlarges the resources put at the sales process as we go. If you remember, there's actually some volume gates also built into the agreement.
Aaron Tachibana: Now under the balance sheet, we finished the second quarter with a strong balance sheet with cash and short term investments of $87 million. During the quarter, we used 8.4 million to fund operations, and we have more than 1.5 years of cash on the balance sheet, which is expected to last through the first quarter of 2026.
Unknown Executive: So that Tempest has agreed not to exceed certain numbers on a year-to-year basis, and we've
Unknown Executive: And we've all been sort of aligned around that. So, you know, part of the challenge here is how to show increasing clinical traction with doctors and investigators so that they're using the product, and they feel comfortable. At the same point in time, managing the burn rate and running those tests, because you want to be at a spot where the run rate of running tests is good enough so that the revenue really explodes when you're able to get reimbursement because you've already got a running start. So we're trying to walk that tightrope, and we've structured the agreement and the commercial rollout plan with Tempest to achieve that, and we believe we're on our way to executing in a way that's consistent.
Chris Hall: And we've all been sort of aligned around that. So the part of the challenge here is how to show increasing clinical traction with doctors and investigators so that they're using the product, and they feel comfortable, at the same point in time, managing the burn rate and running those tests, because you want to be at a spot where the run rate of running tests is good enough so that the revenue really explodes when you're able to get reimbursement because you've already got a running start. So we're trying to walk that tightrope, and we've structured the agreement and the commercial rollout plan with Tempest to achieve that. We think we believe we're on our way to executing in a way that's consistent.
Unknown Executive: and we've all been sort of aligned around that so the idea that part of the challenge here is how to show increasing clinical traction with doctors and investigators so that they're using the product and they feel comfortable at the same point in time managing
Aaron Tachibana: Now I'd like to turn to guidance. For the third quarter of 2024, we expect total company revenue in the range of $21 to $22 million, revenue performance tests, enterprise sales, and other customers in the range of $17 to $18 million, and revenue from population sequencing of approximately $4 million. Service. And for the four-year, we increased our guidance and now expect total company revenue in the range of 79 to 81 billion, and increased from our prior guidance of 76 to 78 million, revenue from farm and test enterprise sales and other customers in the range of 71 to 73 million, and increased from our prior guidance of 68 to 70 million, and this estimate includes revenue from Nutera of approximately 21 to 22 million dollars, of which 5 to 6 million is expected in the second half of the year.
Chris Hall: Because you want to be at a spot where the run rate of running tests is good enough so that the revenue really explodes when you're able to get reimbursement because you've already got a running start. So we're trying to walk that tight rope, and we structured the agreement and the commercial rollout plan with Tempest to achieve that. You think we believe we're on our way to executing on a way that's in system like that.
Unknown Executive: The burn rate in running those tests, because you want to be at a spot where the run rate.
Speaker Change: A running test is...
Unknown Executive: is good enough so that the revenue really explodes when you're able to get reimbursement because you've already got a running start. So we're trying to walk that tightrope.
Unknown Executive: and we structured the agreement and in the commercial rollout plan with tempus to achieve that
Unknown Executive: I think we believe we're on our way to executing in a way that's consistent with that.
Unknown Executive: Got it. And you mentioned in your prepared remarks the publications for each of the key data sets, and for breast, IO, and lung. Any visibility into the timing of that? I guess the follow-on to that would be, you know, what are your expectations now around submission of dossiers to CMS? Yeah, yeah.
Chris Hall: Got it. And you mentioned in your prepared remarks the publications for each of the key data sets, and for breast, IO, and lung. Any visibility into the timing of that? I guess the follow-on to that would be, you know, what are your expectations now around submission of dossiers to CMS? Yeah, yeah.
Thomas Clayton: And you mentioned your prepare to mark the publications for each of the key data sets and breast and IO and one.
Unknown Executive: Got it. And you mentioned in your prepared remarks the publications for each of the key data sets and breast and IO and lung. Any visibility into timing of that? I guess the follow-on to that would be, you know, what are your expectations now around submission of dossiers to CMS?
Chris Hall: Any visibility into timing of that? I guess the fall on to that would be what are your expectations now around submission of dossiers to CMS. Yeah, so a couple of things on that. I mean, all the data has been run and the data has now all been publicly out there. You know, all the data looked awesome. I mean, it was great this quarter to see the breast cancer data, which created a really nice buzz in the community, and in the IO therapy monitor, was also an oral presentation, and it's gotten a lot of interest and excitement.
Chris Hall: Yeah, yeah, so a couple things on that. I mean, all the data has been run, and the data has now all been publicly out there. You know, all the data looked awesome. I mean, it was great this quarter to see the breast cancer data, which created a really nice buzz in the community. And the IO therapy monitor was also an oral presentation, and it's gotten a lot of interest and excitement. And that joins the TRACERx data.
Speaker Change: Yeah, yeah. So, a couple things on that. I mean, all the data has been run and the data has now all been publicly out there and, you know, all the data looked awesome. I mean, it was great this quarter to see the breast cancer data.
Aaron Tachibana: Population sequencing revenue to the approximately 8 million, non-gap net loss of approximately 75 million, a decrease from our prior guidance of 77 million, and exclude any income for expense related to the outstanding warrants issued to Tempest, and cash usage is expected to be approximately 60 million, a decrease from our prior guidance of 62 million dollars.
Speaker Change: which created a really nice buzz in the community and in the Iotherapy Monitor was also a an oral presentation and it's gotten a lot of interest and excitement. And that joins the Tracer X data. So you've got multiple.
Chris Hall: And that joins the Tracer X data. So you've got multiple, multiple studies where the test is really showing that it adds great value. So investigators are working on those papers now. They're being put together, you know. They're all in different phases, but they're all sort of nearing the end of it. We don't actually control the submission of those. They they write and drive those publications because they're in their name. We're optimistic that those will be submitted soon. We'll submit to Medicare as soon as those are published. So, to be clear, like Medicare wants to see a peer review study in order to consider an application.
Chris Hall: So you've got multiple studies where the test is really showing that it adds great value. So investigators are working on those papers now. They're being put together.
Speaker Change: Multiple studies where the test is really showing that it adds great value. So investigators are working on those papers now. They're being put together. You know, they're all in different phases, but they're all sort of nearing the end of it. We don't actually control the submission of those.
Operator: You look forward to updating you on our progress during the next conference call in a few months, and with that, I will turn the call back over to the operator that began the Q&A session.
Chris Hall: You know, they're all in different phases, but they're all sort of nearing the end. We don't actually control the submission of those. They write and drive those publications because they're in their names.
Operator: Operator? Thank you.
Chris Hall: But we're optimistic that those will be published soon, and we'll submit them to Medicare as soon as they are published. So to be clear, Medicare wants to see a peer-reviewed study in order to consider an application. So that's the next step in the journey for us is to have those studies actually done and published, and that's what we're working on, and that's in the investigators' hands right now. Anything to add, Rich? Rich is... So we're on track. The data's looking great, and we're hopeful we can get these published soon. Yeah,
Speaker Change: They write and drive those publications because they're in their name, but we're optimistic that those will be submitted soon. We'll submit to Medicare as soon as those are published. So to be clear, like Medicare wants to see a peer-reviewed study in order to consider an application. So that's the next step.
Operator: Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star, followed by the number one on your touchstone phone, and you will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star, followed by the number two. If you are using a speaker phone, please lift the hand set before pressing any keys. One moment please for your first question.
Chris Hall: So that's the next step in the journey for us is to have those studies actually actually submitted and published. And that's what we're working on, and that's in the investigator's hands right now.
Rich: And the journey for us is to have those studies actually submitted and published, and that's what we're working on, and that's in the investigators' hands right now. If you have anything to add, Rich, Rich is with me.
Rich Chen: Giving dad rich riches with bands. We're on track. It is a few great. And we're hopeful you get these published soon.
Speaker Change: We're on track, it is looking great, and we're hopeful we can get these published soon.
Chris Hall: One of the really great things about us from an executional standpoint is that we are executing on a plan that we laid out more than a year ago about how this would all happen. And we have the data. We've gotten the studies set up. We've gotten the samples in here. We've run the samples. The samples have been discussed in scientific meetings, and the data's all been run, and the papers are all happening exactly the way we had talked about doing them in a plan that we had laid out. So we've been executing at a really, really rapid pace, and I'm proud of the team for bringing it up to this point. I appreciate you taking the questions. Thanks, guys.
Rich Chen: Yeah, it's just one of the really great things about us from an execution standpoint is we are executing on a plan that we laid out more than a year ago about how this all would all happen. And we've we have gotten the data. We've gotten the study set up. We've gotten the samples in here. We run the samples. The samples have been have been discussed and in scientific. You know, scientific meetings and the data's all been run. The papers are all happening exactly the way we had talked about doing it and the plans that we laid out.
Unknown Executive: One of the really great things about us from an executional standpoint is that we are executing on a plan that we laid out more than a year ago about how this would all happen, and we have gotten the data, we've gotten the studies set up, we've gotten the samples in here, we've run the samples, the samples have been discussed in scientific meetings, and the data's all been run, and the papers are all happening exactly So we've been executing at a really, really rapid pace, and I'm proud of the team for bringing it up to this point.
Yuko Oku: Our first question is coming from Yoku, OPPO from Morgan Stanley. Hi, this is Madison on for you go. How are you guys?
Unknown Executive: One of the really great things about us from an executional standpoint is we are executing on a plan that we laid out.
Madison Patricia: I'm out of the same address. Okay, congrats on the corner and thanks for taking the question. I have a two part here, just a first one. I was wondering, should Moderna's PCV eventually secure FDA approval? I was wondering if you could remind us what the potential upside could be on that, and are you specced into the product? Or is it possible that another sequencing vendor could also start to sequence for Moderna once approved? Hi, Madison. Thanks for the question. In terms of the Moderna relationship, so we are ecstatic about how this has been operating. Again, we've been partners with Moderna since 2016 to 2017.
Unknown Executive: More than a year ago about how this all would all happen and we've, we have gotten the data, we've gotten the studies set up.
Unknown Executive: We've gotten the samples in here. We've run the samples. The samples have been
Unknown Executive: have been discussed in scientific.
Unknown Executive: You know, scientific meetings and the data's all been run and the papers are all happening exactly the way we had talked about doing it in the plans that we had laid out. So we've been executing at a really, really rapid pace, and I'm proud of the team for bringing it up to this point.
Rich Chen: So we've been executing it really, really rapid pace. And I'm proud of the team for bringing it up to this point. Great.
Thomas Flaten: Great. Appreciate you taking the questions.
Rich Chen: Appreciate taking the questions. Thanks.
Speaker Change: Great, appreciate you taking the questions. Thanks guys.
Unknown Executive: Thanks.
Joseph Conway: Our next question will be coming from Mike Maxson from Need Tab.
Mike Mattson: Our next question will be coming from Mike Mattson from Needham.
Unknown Executive: Our next question will be coming from Mike Matson from NEDAP.
Joseph Conway: Hey guys, this is Joseph on from Mike. A couple of questions here. Maybe I think you said 4% there was a 4% I guess revenue had run what are you going to call it from clinical test that weren't reimbursed. Are these tests that you plan to go out there for reimbursement, or are you kind of already excluded this from future revenue? Yeah, I mean, we we we the cost are in the quarter. We certainly don't insurance companies for them, but we just don't expect to get paid for them because they're not they're not medically necessary or the case of medic care.
Joseph Conway: Hey guys, this is Joseph. I'm from Mike. I have a couple of questions here.
Unknown Executive: Hey guys, this is Joseph. I'm from Mike. A couple of questions here. Maybe, I think you said 4%.
Madison Patricia: In terms of where this goes upon commercialization, that's something from Moderna to talk about. We're not really talking too much about the upside or the opportunity. We just know that it is a huge opportunity for us, we're excited about it, but that should come from the Moderna folks to talk about. In terms of the offering, so again, today samples are taken from patients, and the patient samples are sent to personnel as we profile them.
Unknown Executive: There was a 4% revenue headwind, I guess, what do you want to call it, from clinical tests that weren't reimbursed.
Joseph Conway: Maybe I think you said 4%. There was a 4%, I guess, revenue headwind, what do you want to call it, from clinical tests that weren't reimbursed? Are these tests that you plan to go after for reimbursement, or have you kind of already excluded this from future revenue?
Speaker Change: There was a 4% I guess revenue headroom, what do you want to call it, from clinical tests that weren't reimbursed. Are these tests that you plan to go after for reimbursement or have you kind of already excluded this from future revenue?
Chris Hall: Yeah, I mean, we, we, we, the cost is in the quarter. We certainly bill insurance companies for them, but we just don't expect to get paid for them because they're not, they're not medically necessary, or in the case of Medicare.
Madison Patricia: And we send back this rich, informative set of data back to Moderna, so they can then customize a vaccine or therapy for that individual patient. In terms of, again, the relationship, you know, we believe we have a very, very solid relationship and, you know, maternal values are platform. So in terms of the longer term prospects, you know, we feel very confident about going into the future.
Speaker Change: Yeah, I mean, we, we, we, we, the cost are in the quarter. We certainly bill insurance companies for them, but we just don't expect to get paid for them because they're not, they're not medically necessary or in the case of Medicare.
Chris Hall: But so they weighed down gross margin. So I think Aaron's point was, if they hadn't have, if those hadn't have been in there weighing them down, which is all part of the investment we're making into growth, and I think you think we all appreciate what we're doing there, the gross margin would have been near 40%. So we've made tremendous progress, which is large, with the Gross Marketing Company.
Madison Patricia: Got it. Okay, let's get to here.
Chris Hall: But, so they they wait down gross margin. So I think Aaron's point was if they hadn't have, if those hadn't been in their way and I'm down, which is all part of the investment we're making into the growth. And I think you think we all appreciate what we're doing there. The gross margin would have been near 40%. So we made tremendous progress. I think is the larger point. Yeah, absolutely, tremendous progress on margins and cash burn overall. I guess maybe just on cash burn, the reduction in the guidance for cash burns just curious, is that coming from further, I guess cost reduction initiatives or was this mostly coming from, you know, upside from raising the revenue guidance.
Speaker Change: but you
Unknown Executive: But so they weighed down gross margin, so I think Aaron's point was if they hadn't have, if those hadn't have been in there weighing them down, which is all part of the investment we're making into the growth, and I think you think we all appreciate what we're doing there, the gross margin would have been near 40%, so we've made tremendous progress there.
Speaker Change: I think is the larger point.
Joseph Conway: Yeah, absolutely. Tremendous progress on margins and cash burn overall. I guess maybe just on cash burn, the reduction in the guidance for cash firms, just curious, is that coming from further, I guess, cost reduction initiatives, or was this mostly coming from, you know, the upside from raising the revenue guidance?
Speaker Change: with the gross. Yeah.
Speaker Change: Yeah, absolutely. Tremendous progress on margins and cash burn overall. I guess maybe just on cash burn, the reduction in the guidance for cash burns, just curious, is that coming from
Madison Patricia: And then, just on with Tempest launching their own MRD solution, I was wondering how you make sure that they are incentivized to also market the next person out personal like what is the kind of incentive structure there, put in place for the product so that they get an equal commercial push from the sales force. Yeah, no, great question. I mean, first of all, just backing up while we're on the Tempest requisition, like we're growing the number of Tempest sales reps that are selling the product over time aggressively to be able to get the volume.
Unknown Executive: Further, I guess, cost reduction initiatives, or was this mostly coming from, you know, the upside from raising the revenue guidance?
Speaker Change: Further, I guess, cost reduction initiatives, or was this mostly coming from, you know, upside from raising the revenue guidance?
Joseph Conway: It's really from the revenue and the gross profit, right? Revenue went up $3 million, and gross profit.
Aaron Tachibana: It's really from the revenue and the gross profit, right? Revenue went up $3 million, gross profit. There as well.
Joseph Conway: It's really fun.
Speaker Change: It's really from the revenue and the gross profit, right? Revenue went up $3 million, gross profit.
Joseph Conway: Okay, great.
Joseph Conway: Okay, great. And then, just maybe, one more.
Joseph Conway: And then just maybe one more. You've mentioned the Duke data set. It's being predictive. I assume this was Immuno ID of immunotherapy response. Just curious. Sorry, yeah. It's actually next personal with the MRD product. Oh, I see. Okay. That makes perfect sense. But I guess the question then, do you see that use case mostly sticking with pharma, or is there a potential to use that use case in the clinical setting for immunotherapy eligibility? No, absolutely. Certainly across the clinic. It's one of the large use cases for these MRD assays because doctors, you know, it's tough.
Speaker Change: There as well.
Speaker Change: Okay, great. And then just maybe one more. You had mentioned the Duke data set being predictive. I assume this was immuno ID of immunotherapy response. Just curious if you kind of see that use it.
Joseph Conway: You've mentioned the Duke data set being predictive. I assume this was an immuno ID of the immunotherapy response. Just curious if you kind of see that used.
Madison Patricia: So, you know, it's like right now we're, we're, we're starting the journey and moving it up slowly. Tempest's product is a, is a blood base. It's not, it's not, it's not the same type of product. It's a tumor naive product or it's a tumor normal product. They've positioned it in a colorectal cancer or persistent it on breast and IO therapy monitoring. So products are position will be differently. And I think it's actually really, really great to have both products under the same roof.
Chris Hall: It's actually next personal; it's the MRD product.
Speaker Change: It's actually an ex-personal, it's the MRD product.
Chris Hall: Oh, I see. Okay. Okay, that that makes perfect sense. But I guess the question then, do you see that use case mostly sticking with pharma? Or is there a potential to use that use case in the clinical setting for immunotherapy?
Speaker Change: oh i see okay okay that that makes perfect sense but i guess the question then do you see that use case mostly staking with pharma or is there a potential to use that use case and the clinical setting for e munoapy eligibility
Chris Hall: No, absolutely, certainly across the clinic, it's one of the large use cases for these MRD assays because doctors, you know, it's tough. You're stimulating the immune system, and so it's tough on imaging to see whether or not your therapy is working, because you could have an immune response, and the tumor looks like it's growing on imaging. It looks like the patient's getting worse, but indeed, the immune system and the drugs are working exactly the way you would think they would. So you'd be, you would be misled.
Madison Patricia: Because the truth is, for some patients, you're not going to have the access to the, you're not going to have access to the tissue and you're just going to have access to the blood. And so I think, I think if you just step back and think about it, Tempest is uniquely the company that stitched together both a tumor naive and a tumor and a tumor normal approach, you know, approach under one roof and they really set up to accelerate growth in the marketplace with a comprehensive offering. So we actually think the two products work together really well and I think that's how Tempest is viewing it and in a set up nicely. Got it. That's good to hear.
Speaker Change: No, absolutely, certainly across the clinic, it's one of the large use cases.
Unknown Executive: for these MRD assays because doctors, you know, it's tough. You're stimulating the immune system, and so it's tough on imaging to see whether or not your therapy's working, because you could have an immune response, and the tumor looks like it's growing on imaging. It looks like the patient's getting worse, but indeed, the immune system and the drugs are working exactly the way you would think they would, so you would be misled.
Chris Hall: You're stimulating the immune system. And so it's tough on imaging to see whether or not your therapy is working because you could have an immune response, and the tumor looks like it's growing on imaging. Looks like the patient's getting worse, but indeed the immune system and the drugs are working exactly the way you would think it would be. You would be misled. And so these blood tests are actually, I think, taking over for doing a lot of the heavy lifting in terms of monitoring. So it's one of the key use cases. There are now three data sets supporting the use here.
Unknown Executive: for these MRD assays.
Madison Patricia: Thanks so much for the time.
Unknown Executive: because doctors, you know, it's tough, you're stimulating the immune system.
Unknown Executive: And so it's tough on imaging to see whether or not your therapy is working because you could have an immune response and the tumor looks like it's growing.
Unknown Executive: On imaging, it looks like the patient's getting worse, but indeed, the immune system and the drugs are working exactly the way you would think it would be.
Unknown Executive: And so these blood tests are actually, I think, taking over for doing a lot of the heavy lifting in terms of monitoring, so it's one of the key use cases. There are now three data sets supporting its use here. One is with UKE, which is melanoma, and another one with Duke, which is gastric patients, and then the VHIO data set, which is pan-cancer. That's really the key one, and the other two support it, so there are three data sets that are coming together to support the reimbursement for IO therapy monitoring, and it's one of the key use cases. Anything to add, Rich? Yeah, no, it's just like you said. 40% of all cancer patients are eligible for immunotherapy, but actually...
Chris Hall: And so these blood tests are actually, I think, taking over for doing a lot of the heavy lifting in terms of monitoring. So it's one of the key use cases. There are now three data sets supporting the use of this here. One is with UKE, which is melanoma, and another one with Duke, which is gastric patients, and then the VHIO data set, which is pan-cancer. That's really the key one, and the other two support it. So there are three data sets that are coming together to support reimbursement for Iotherapy monitoring, and it's one of the key use cases. Anything to add, Richard?
Unknown Executive: You would be misled. And so these blood tests are actually, I think, taking over for doing a lot of the heavy lifting in terms of monitoring.
Unknown Executive: So it's one of the key use cases. There are now three data sets.
Chris Hall: One is with UK, which is melanoma. Another one with Duke, which is the gastric patients. And then the VHIO data set, which is pan cancer. That's really the key one. And the other two support it. So there's three data sets that are coming together to support the reimbursement for Iofia. therapy monitor. And it's one of the key use cases in the average. Yeah. No, it's just like you said. You know, 40% of all cancer patients are eligible for immunotherapy, but actually only 12% of patients actually respond. So if you think about that. It becomes really critical to be able to understand whether these patients are actually having a response to the therapy.
Unknown Executive: Supporting the use here, one is with UKE, which is melanoma.
Mark Massaro: Thanks, Madison. Next question on the line will be coming from Mark Nasserow from BDIG. Hey guys, this is Vivian on Cromark. Thanks for taking the questions. I just want to touch on next personal reimbursement. I just want to find this kind of thinking about a potential crosswalk or gap so there for pricing. Just the way you think that will land and any potential upside as it relates to potential ADLT status. Thanks.
Unknown Executive: another one with Duke, which is the gastric patients, and then the VH-IO data set, which is pan-cancer. That's really the key one, and the other two support it. So there's three data sets that are coming together to support the reimbursement for IO therapy monitoring, and it's one of the key use cases.
Rich: Anything to add, Rich? Yeah, no, it's just like you said, you know, 40% of all cancer patients are eligible for immunotherapy, but actually only 12% of patients actually respond. So if you think about that, it becomes really critical to be able to understand whether these patients are actually having a response to immunotherapy.
Unknown Executive: actually respond. So if you think about that, it becomes really critical to be able to understand whether these patients are actually having a response to chemotherapy. And so MRD is definitely one of the key tools that they can use now. And we're showing data that is highly predictive of response. And so that's definitely one of the key indications.
Chris Hall: That becomes really critical to be able to understand whether these patients are actually having a response to chemotherapy. And so in March,
Mark Massaro: Yeah, great question. I mean, I, we build all of our economic models. I mean, we get similar to what other players have been reimbursed in the marketplace, but there's a couple, you know, different shots on goal. To drive that higher one is that the testman of itself is is a more resource intensive test than an exo-based test. Medicare reimburses based on that. So we think that's one, one way just fundamentally that the test should be priced higher because it's a more resource intensive test to run, which is how these tests ultimately are priced.
Chris Hall: And so MRD is definitely one of the key tools now that they can use. And we're showing the data that is highly predictive of response. And so that's definitely one of the key indications. I see. Okay. It makes perfect sense. I had read that comment as I guess testing for eligibility pre-treatment rather than monitoring. But thanks for claiming that out. No, absolutely. It's monitoring. It's key. And it's one of the big parts of the $20 billion estimated $20 billion market.
Unknown Executive: And so MRD is definitely one of the key tools now that they can use, and we're showing the data that is highly predictive of response, and so that's definitely one of the key indications.
Joseph Conway: I see, okay, it makes perfect sense. I had read that comment as, I guess, testing for eligibility pre-treatment rather than monitoring, but thanks for clearing that up. No, absolutely not.
Unknown Executive: I see, okay, it makes perfect sense. I had read that comment as, I guess, testing for eligibility pre-treatment rather than monitoring, but thanks for clearing that up. No, absolutely not.
Speaker Change: I see, okay, makes perfect sense. I had read that comment as, I guess, testing for eligibility pre-treatment rather than monitoring, but thanks for clearing that up.
Unknown Executive: No, absolutely not. It's monitoring. It's key. And it's one of the big parts of the $20 billion, estimated $20 billion market.
Unknown Executive: It's monitoring. It's key. And, and it's one of
Joseph Conway: It's monitoring. It's key. And, and it's one of the big parts of the $20 billion, estimated $20 billion market.
Unknown Executive: No, absolutely it's monitoring. It's key and it's one of the big parts of the $20 billion, estimated $20 billion market.
Mark Massaro: And secondarily, there is, there is a shot to get ADLT status so we're working on management. But the expectation we've set is that we're, we're tracking to have gross margins greater than 60% even if we don't achieve any of those things. We're set up well and the tempest relationship brings sales and marketing costs down in that 20 to 25% raise.
Joseph Conway: Thanks.
Unknown Executive: Thanks.
Operator: Should you have further questions, please press star. Follow with a number one on your touch-tone phone. And you will hear a prompt that your hand has been raised.
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Mark Massaro: And so we built the economics from there and then the rest of it will just drive the numbers to be a more innovative before we're able to achieve higher reimbursement. Thank you so much for the color there. And I'm just going to follow up, Moderna has sort of exceeded expectations. Can you just remind us, I think they've expanded the number of indications they're looking at on PCV. So maybe just touch on that and then also your longer term outlook on the farm aside of the business.
Operator: Again, should you have a question, please press the star followed by the number one on your touchtone phone, and then you will hear a prompt that your hand has been raised.
Arthur He: Our next question will be coming from our 30 from each ceiling, right?
Operator: Our next question will be coming from Arthur He from H.C. Wainwright.
Arthur He: Hey, good afternoon, Chris and Aaron. These are the authors of our case of Congressional quarter. I had a couple. I had a couple quick ones. So, first regarding the total medical test, the 500-661, how about the physician right now you wrote in the EAP, that their number? Bumped also? Well, that includes all the tests that we got, which are from those physicians, and some Tempest physicians that were added towards the late of the last quarter. So, they're coming from that group. Now, we did grow the number of physicians. We started with 10, and we've been slowly growing out, and so there are more physicians being added, not particularly great clip, but that's what that is.
Arthur He: Hey, good afternoon, Chris and Aaron. These are the authors for our case, a congressional recorder. I had a couple of quick questions. So first, regarding the total molecular test, the 561, how about the physician right now enrolled in the EAP? Does that number bump also?
Arthur He: Hey, good afternoon, Chris and Aaron. These are the authors of our case, a congressional recorder. I had a couple of questions. I had a couple of quick ones. So first, regarding the total molecular test, the 561. How about the physician right now enrolled in the EAP? Has that number bumped up also?
Arthur He: Hey, good afternoon, Chris and Aaron. This is Otto for our case, a congressional recorder. I had a couple of quick questions.
Arthur He: I had a couple of quick ones. So first, regarding the total molecular test, the 561, how about the physician right now enrolled in the EAP? Does that number bump also?
Mark Massaro: Thanks. Sure. Thanks, Vidyun. So in terms of the Moderna relationship, remember, they're in the phase three clinical trial right now with melanoma patients. They had three success in phase two in terms of the volume that we're seeing today. A lot of that is because of the phase three trial. So the number of patients in the phase three trial, significantly outpaced what you'll see in phase one or phase two. In terms of other cancer types, yes, they are focused on additional cancer types as well, right.
Unknown Executive: That's Tom. Well, that includes all the tests that we got, which are which are from those physicians, and some Tempest physicians that were added towards the late of the last quarter. So, they're coming from that group. Now, we did grow the number of physicians. We started with ten, and we've been slowly growing that out. And and so are more physicians being added?
Chris Hall: That's Tom. Well, that includes all the tests that we got, which are which are from those physicians, and some Tempest physicians that were added towards the late of the last quarter. So, they're coming from that group. Now, we did grow the number of physicians. We started with ten, and we've been slowly growing that out. And and so are more physicians being added?
Unknown Executive: that's
Unknown Executive: Well, that includes all the tests that we got, which are from those physicians.
Unknown Executive: and some Tempest physicians that were added towards the late of the last quarter or so.
Unknown Executive: So they're coming from that group. Now, we did grow the number of physicians. We started with 10, and we've been slowly growing that out. And so there are more physicians being added. Not in a particularly great clip, but that's what that is.
Mark Massaro: But in terms of, you know, talking too much in terms of specifics that something again, that should come from them, but they are working on others as well. Great. Thanks so much for taking the questions. Thank you.
Unknown Executive: Not a particularly great clip, but that's what that is.
Chris Hall: Not a particularly great clip, but that's what that is.
Arthur He: Got you. Thanks for the comment. And my second question is, so regarding the RAVR guidance for revenue.
Arthur He: Got you. Thanks for the comment.
Chris Hall: Gotcha, thanks for the comments. And my second question is, so regarding the razor guidance, for the regarding revenue, it's in the coming morph on the farmer testing business, I'm just curious, is these driven more by the IND service, or there's some interest in the next person though, thrown the farmer? So, it's actually both. So, most of the revenue today is from ImmunoID Next. The pharmaceutical business has been very, very strong over the last few quarters in Q2, especially. The pipeline for next personal with our biopharma customers is growing rapidly, and so we're going to start to see that start to take up over the next few quarters here as we go forward.
Arthur He: Got you, thanks for the comment. And my second question is, so regarding the the RAVER guidance for the regarding revenue
Arthur He: And my second question is, regarding the RAVR guidance for revenue, is FEMA coming more from the pharma testing business? I'm just curious, is this driven more by the in your ID service, or is there some interest in the next person from pharma?
Thomas Clayton: Next question will be coming from Thomas Clayton from Lake Street. You're afternoon guys. I appreciate you taking the questions. Chris, you mentioned in an earlier response, you know, kind of gating the tempest efforts here in the near term. Can you talk to us a little bit about exactly how you're going to do that, you know, how many reps are you going to bring bring on and how are you going to pace those reps.
Speaker Change: It seems coming more from the farmer testing business. I'm just curious, is this driven more by the in-ear IED service or there's some interest in the next personal from the farmer?
Chris Hall: So it's actually both. So most of the revenue today is from ImmunoID Next. The pharmaceutical business has been very, very strong over the last few quarters, and Q2 especially. The pipeline for next personal, with our biopharma customers, is growing rapidly. And so we're going to start to see that start to pick up over the next few quarters here as we go forward.
Speaker Change: So, it's actually both. So, most of the revenue today is from ImmunoID Next. The pharmaceutical business has been very, very strong over the last few quarters, and Q2 especially.
Unknown Executive: The pharmaceutical business has been very, very strong over the last few quarters, in Q2 especially. The pipeline for next personal, with our biopharma customers, is growing rapidly. And so we're going to start to see that start to pick up over the next few quarters here as we go forward.
Thomas Clayton: So you don't overburden the system with too much volume when you're not getting paid any color that will be super helpful. Yeah, yeah, so they we've started out with with a small number of tempest reps that are actually in a trained and marketing and talking about the product and the plan is to grow that over time. So it's a to graduate it or you know, approach that's that enlarges the resources put at the sales process as we go.
Unknown Executive: The pipeline for next personal with our biopharma customers.
Unknown Executive: growing rapidly and so we're going to start to see that start to take up over the next few quarters here as we go forward.
Chris Hall: Gotcha, that's good here. And the last question is, so for the next person though, what's your plan when you're looking beyond the breast cancer, lung cancer, and IO therapy monitoring? What's the potential beyond that? We haven't really stated anything beyond that. Just yet, Arthur, so right now we're focused on these cancer types. It's close to half of the market; it's going to give us plenty of things to keep us busy with over the next couple of years. So, right now we're hunkered down and focused on these cancer types too.
Arthur He: Gotcha. That's good here. And the last question is, so for the next person, though, what's your plan when you're looking beyond breast cancer and lung cancer?
Speaker Change: got that's good here the last question is so for the next personneal what's old plan when you're looking beyond the breast cancel on kcans and io therapy monitoring what's the potential beyond there
Thomas Clayton: So if you remember, there's actually some volume gates also build and agreement. So the tempest is agreed not to exceed certain numbers on a year to your basis and we've and we've all been sort of aligned around that. So the part of the challenge here is how to show increasing clinical traction with doctors and investigators so that they're using the product and they feel comfortable at the same point time managing the burn rate and running those tests.
Chris Hall: Well, we haven't really stated anything beyond that just yet, Arthur. So right now, we're focused on these cancer types. It's, you know, close to half of the market. It's going to give us plenty of things to keep us busy over the next couple of years. So right now, we're hunkered down and focused on these cancer types. Thanks, Aaron, and thanks for joining us.
Unknown Executive: Well, we haven't really stated anything beyond that just yet, Arthur. So right now, we're focused on these cancer types.
Unknown Executive: Well, we haven't really stated anything beyond that just yet, Arthur, so right now we're focused on these two cancer types.
Arthur He: It's you know close to half of the market. It's going to give us plenty of things to keep us busy with over the next couple of years. So right now we're hunkered down and focused on these cancer types.
Thomas Clayton: Because you want to be at a spot where the run rate of running test is good enough so that the revenue really explodes when you're able to get reimbursement because you've already got a running start. So we're trying to walk that tight rope and we structured the agreement and the commercial rollout plan with tempest to achieve that. You think we believe we're on our way to executing on a way that's in system like that.
Aaron Tachibana: Gotcha, thanks, Aaron.
Arthur He: Thanks, Aaron, and thanks for taking my question.
Arthur He: Got you. Thanks Aaron. And thanks for taking my question.
Arthur He: I got it.
Daniel Brennan: Go ahead, Arthur. We have another question from Dan Brennan of TB Cohen.
Arthur He: Go ahead, Arthur. We have another question from Dan Brennan of TB Cohen.
Dan Brennan: We have another question from Dan Brennan from Phoebe Cohen. Hey, it's John from Dan. So it was really nice revenue performance from the quarter at 226, which is one your way to the run rate to hit the 100 million in 2025 levels.
Speaker Change: We have another question from Dan Brennan from PBKohen.
Daniel Brennan: Hey, it's John from DAB.
Thomas Clayton: And you mentioned your prepare to mark the publications for each of the key data sets and breast and IO and one. Any visibility into timing of that? I guess the fall on to that would be what are your expectations now around submission of dossiers to CMS. Yeah, so a couple of things on that. I mean, all the data has been run and the data has now all been publicly out there. You know, all the data looked awesome.
Dan Brennan: So it was a really nice revenue performance in the quarter, at $22.6 million, which is well on your way to the run rate to hit the $100 million in 2025 levels. So as we get closer, can you just share some thoughts about how you're feeling about achieving this milestone, especially with the Notera business rolling off? It would be great if you could kind of walk through expectations for different revenue buckets in terms of like MRD, vaccines, enterprise, and VA.
Daniel Brennan: So it was a really nice revenue performance in the quarter, at $22.6 million, which is well on your way to the run rate to hit the $100 million in 2025 levels. So as we get closer, can you just share some thoughts about how you're feeling about achieving this milestone, especially with the Notera business rolling off? It would be great if you could kind of walk through expectations for different revenue buckets in terms of like MRD, vaccines, enterprise, and VA. Shug.
Dan Brennan: Hey, it's John from DAB.
Dan Brennan: So it's really nice to have new performance in the quarter at 22.6, which is well on your way to the run rate to hit the 100 million in 2025 levels.
Aaron Tachibana: So it's to get closer, can you just share some thoughts about how you're feeling about achieving this milestone, especially with Nutera, business rolling off, and be great if you could kind of walk through expectations for a different revenue bucket in terms of like MRD vaccines and a prize and VIA. Sure, great. Thanks for the question. In terms of looking ahead into 2025, we haven't given specific guidance to the buildup of it, but the way to look at it. So in Chris' prepared remarks, he talked about the enterprise work with Nutera ending by the end of this year.
Speaker Change: So as we get closer, can you just share some thoughts about how you're feeling about achieving this milestone, especially with Natera business rolling off? It would be great if you could kind of walk through expectations for different revenue buckets in terms of like MRD, vaccines, enterprise, and VA.
Unknown Executive: Sure, great. Thanks for the question. In terms of looking ahead into 2025, we haven't given specific guidance. So, you know, we're optimistic that there could be something on the horizon as well. The VAMVP might be seven to eight million dollars. So if you assume the current run rate there.
Aaron Tachibana: Sure, great. Thanks for the question. In terms of looking ahead into 2025, we haven't given specific guidance on the buildup of it, but the way to look at it. So in Chris's prepared remarks, he talked about the, you know, the enterprise work with Natera ending by the end of this year. So we can assume, and you can assume that there's going to be zero from Natera in 2025.
Unknown Executive: Sure, great. Thanks for the question. In terms of looking ahead into 2025, we haven't given specific guidances.
Thomas Clayton: I mean, it was great this quarter to see the breast cancer data, which created a really nice buzz in the community and in the IO therapy monitor was also an oral presentation and it's gotten a lot of interest and excitement. And that joins the Tracer X data. So you've got multiple, multiple studies where the test is really showing that it adds great value. So investigators are working on those papers now. They're being put together, you know, they're all in different phases, but they're all sort of nearing the end of it.
Chris: to the buildup of it, but the way to look at it, so in Chris's prepared remarks he talked about the enterprise work with Natera ending by the end of this year, so we can assume and you folks can assume that there's going to be zero from Natera in 2025.
Chris Hall: So we can assume, and you folks can assume that there's going to be zero from Nutera in 2025. We're going to have about $22 million in $24 from Nitarra. You could assume most of that is going to be offset by our biopharma increase. Biopharma will increase from not only Immune ID next, but also next personal. Again, the funnel is blowing immensely. We're expecting that to start to take up your over the next few quarters. In addition, we're also engaged in looking for additional enterprise. The enterprise type of work, and so we're optimistic that there could be something on the horizons as well.
Aaron Tachibana: We're going to have about $22 million in 24 from TERRA. You could assume most of that is going to be offset by our biopharma increase. Biopharma will increase not only ImmunoID Next but also Next Personal. Again, the funnel is growing immensely, and we're expecting that to start to pick up here over the next few quarters. In addition, we're also engaged and looking for additional enterprise-type work. So, you know, we're optimistic that there could be something on the horizon as well.
Unknown Executive: We're going to have about $22 million in 24 from the TERRA. You could assume most of that is going to be offset by our biopharma increase.
Thomas Clayton: We don't actually control the submission of those. They they write and drive those publications because they're in their name. We're optimistic that those will be submitted soon. We'll submit to Medicare as soon as those are published. So to be clear, like Medicare wants to see a peer review study in order to consider an application. So that's the next step in the journey for us is to have those studies actually actually submitted and published. And that's what we're working on and that's in the investigator's hands right now. Giving dad rich riches with bands. We're on track. It is a few great. And we're hopeful you get these published soon.
Unknown Executive: Biopharma will increase not only ImmunoID Next, but also Next Personal.
Unknown Executive: Again, the funnel is growing immensely and we're expecting that to start to take up here over the next few quarters. In addition, we're also engaged and looking for additional enterprise type of work.
Unknown Executive: And so, you know, we're optimistic that there could be something on the horizon as well. The VAMVP might be $7 to $8 million, so if you assume the current run rate there.
Aaron Tachibana: The VAMVP might be $7 to $8 million, so if you assume the current run rate there, it's going to be flat. All right, but most of the buildup or growth is going to come from biopharma.
Aaron Tachibana: The VAMVP might be $78 million, so if you assume the current rent rate there, it's going to be flat. But most of the buildup growth is going to cut from biopharma.
Unknown Executive: You know, that's it's going to be flat. All right, but most of the buildup or growth is going to come from biopharma.
Christopher Hall: Yeah, it's just one of the really great things about us from an execution standpoint is we are executing on a plan that we laid out more than a year ago about how this all would all happen. And we've we have gotten the data. We've gotten the study set up. We've gotten the samples in here. We run the samples. The samples have been have been discussed and in scientific. You know, scientific meetings and and the data's all been run. The papers are all happening exactly the way we had talked about doing it and the plans that we laid out. So we've been executing it really, really rapid pace.
Dan Brennan: Got it. And then It would be great to get a little more color on the Myriad deal. It's what we're both Personalis Myriad looking to get out of this agreement. And then maybe, in the lens of like, it seems Personalis is kind of changing its IP strategy from one where you were previously enforcing your patents, and now it seems like you're sharing your IP with Myriad and settling with Foresight. Yeah, I mean, I think it's all about patient access.
Daniel Brennan: Got it. And then It would be great to get a little more color on the Myriad deal. Just what were both Personalis and Myriad looking to get out of this agreement? And then maybe, in the lens of, it seems Personalis is kind of changing its IP strategy from one where it was previously enforcing your patents, and now it seems like you're sharing your IP with Myriad and settling with Foresight. Yeah, I mean, I think it's all about patient access.
Chris Hall: And then it would be great to get a little more color on the Myriad deal. This is what we're both personnel. I'm looking to get out of the agreement, and then maybe in the end of, like, it seems personnel is kind of changing its IP strategy from one where you were previously enforcing your patents. And now it seems like you're sharing your IP with the area and settling the foresight. I think it's all about patient access and having a model that is comprehensive and large and helps all build the market. But in a way that actually you want to create value for the IP.
Dan Brennan: that
Dan Brennan: And then it would be great to get a little more color on the Myriad deal, just what were both Personalis and Myriad looking to get out of this agreement, and then maybe in the lens of like, it seems Personalis is kind of changing its IP strategy from one where you were previously enforcing your patents, and now it seems like you're sharing your IP with Myriad and settling with Foresight, so.
Chris Hall: Yeah, I mean, I think it's all about patient access and having a model that is comprehensive and enlarging and helps everyone build the market, but in a way that actually, you know, you want to create value for the IP. So in the case of Myriad, you know, they had a lot of deep foundational work there.
Unknown Executive: Yeah, I mean, I think it's all about patient access and having a model that is comprehensive and enlarging and helps everyone build the market, but in a way that actually, you know, you want to create value for the IP. So in the case of Myriad, you know, they had a lot of deep foundational work there.
Unknown Executive: Yeah, I mean, I think it's all about patient access.
Unknown Executive: and having
Unknown Executive: a model that you know is comprehensive and enlarging and helps all build the market and but in a way that actually you know you want to create value for the IP.
Christopher Hall: And I'm proud of the team for bringing it up to this point. Great.
Chris Hall: So, in the case of Myriad, they had a lot of depoundational work there. And by doing the cross-license deal, we give each other, you know, make sure that we each other can move in a way that we both have freedom to operate. And I think that's really good for both companies, for shareholders, and for patients and doctors, and as a way for us to be appropriately spending money in the case of foresight. And there's some great IP, and we end up with royalties there and moving forward. You know, we'll continue to find ways to bring value for the IP that we've developed.
Thomas Clayton: Appreciate taking the questions. Thanks.
Unknown Executive: So in the case of Myriad, you know, they had a lot of deep foundational work there and by doing a cross license deal we give
Unknown Executive: And by doing a cross-license deal, we give each other, you know, make sure that we can move in a way that we both have freedom to operate. And I think that's really good for both companies, for shareholders, and for patients and doctors and as a way for us to be appropriately spending money in the case of Foresight. And there's some great IP that and we end up, we end up with royalties there, and moving forward, you know, we'll continue to find ways to bring value for the IP that we've developed.
Chris Hall: And by doing a cross-license deal, we give each other, you know, make sure that we can move in a way that we both have freedom to operate. And I think that's really good for both companies and for shareholders and for patients and doctors and as a way for us to be appropriately spending money. In the case of Foresight, you know, there's some great IP that, and we'll end up, we end up with royalties there, and moving forward, we'll continue to find ways to bring value for the, for the, for the, for the, for the, for the, for the, for the, for the, for the, for the, for the, for the, for the, for the, for the, for the,
Joseph Conway: Our next question will be coming from Mike Maxson from need tab. Hey guys, this is Joseph on from Mike. A couple of questions here. Maybe I think you said 4% there was a 4% I guess revenue had run what are you going to call it from clinical test that weren't reimbursed. Are these tests that you plan to go out there for reimbursement or are you kind of already excluded this from future revenue.
Unknown Executive: You know, each other, you know, make sure that we each other can move in a way that.
Unknown Executive: we both have freedom to operate and i think that's really good for both companies for shareholders and for patients and doctors and is a way for us to pe
Unknown Executive: Appropriately Spending Money in the Case of Foresight.
Unknown Executive: There's some great IP, and we end up with royalties there, and moving forward, we'll continue to find ways to bring value for the IP that we've developed.
Chris Hall: Got it.
Unknown Executive: Thanks.
Joseph Conway: Yeah, I mean, we we we the cost are in the quarter. We certainly don't insurance companies for them, but we just don't expect to get paid for them because they're not they're not medically necessary or the case of medic care. But so they they wait down gross margin. So I think Aaron's point was if they hadn't have if those hadn't been in their way and I'm down, which is all part of the investment we're making into the growth.
Speaker Change: Got it. Thanks.
Operator: There are no further questions at this time.
Operator: There are no further questions at this time, ladies and gentlemen.
Operator: There are no further questions at this time. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your line. Goodbye. Have a good one.
Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask if you please disconnect your line. Goodbye. Have a good one.
Operator: There are no further questions at this time. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Goodbye. Have a good one.
Joseph Conway: And I think you think we all appreciate what we're doing there. The gross margin would have been near 40%. So we made tremendous progress. I think is the larger point. Yeah, absolutely, tremendous progress on margins and cash burn overall. I guess maybe just on cash burn, the reduction in the guidance for cash burns just curious, is that coming from further, I guess cost reduction initiatives or was this mostly coming from, you know, upside from raising the revenue guidance.
Joseph Conway: It's really from the revenue and the gross profit, right? Revenue went up $3 million, gross profit. There as well. Okay, great. And then just maybe one more. You've mentioned the Duke data set. It's being predictive. I assume this was immuno ID of immunotherapy response. Just curious. Sorry, yeah. It's actually next personal with the MRD product. Oh, I see. Okay. That makes perfect sense. But I guess the question then, do you see that use case mostly sticking with pharma or is there a potential to use that use case in the clinical setting for immunotherapy eligibility?
Joseph Conway: No, absolutely. Certainly across the clinic. It's one of the large use cases for these MRD assays because doctors, you know, it's tough. You're stimulating the immune system. And so it's tough on imaging to see whether or not your therapy is working because you could have an immune response and the tumor looks like it's growing on imaging. Looks like the patient's getting worse, but indeed the immune system and the drugs are working exactly the way you would think it would be.
Joseph Conway: You would be misled. And so these blood tests are actually, I think, taking over for doing a lot of the heavy lifting in terms of monitoring. So it's one of the key use cases. There are now three data sets supporting the use here. One is with UK, which is melanoma. Another one with Duke, which is the gastric patients. And then the VHIO data set, which is pan cancer. That's really the key one.
Joseph Conway: And the other two support it. So there's three data sets that are coming together to support the reimbursement for Iofia, therapy monitor. And it's one of the key use cases in the average. Yeah. No, it's just like you said, you know, 40% of all cancer patients are eligible for immunotherapy, but actually only 12% of patients actually respond. So if you think about that. It becomes really critical to be able to understand whether these patients are actually having a response to the therapy.
Joseph Conway: And so MRD is definitely one of the key tools now that they can use. And we're showing the data that is highly predictive of response. And so that's definitely one of the key indications. I see. Okay. It makes perfect sense. I had read that comment as I guess testing for eligibility pre-treatment rather than monitoring. But thanks for claiming that out. No, absolutely. It's monitoring. It's key. And it's one of the big parts of the $20 billion estimated $20 billion market. Thanks. Should you have further questions, please press star. Follow with a number one on your touch tone phone. And you will hear a prompt that your hand has been raised.
Arthur He: Our next question will be coming from our 30 from each ceiling right.
Arthur He: Hey, good afternoon, Chris and Aaron. These are the author of our case of congressional quarter. I had a couple. I had a couple quick ones. So, first regarding the total medical test, the 500-661, how about the physician right now you wrote in the EAP, that their number? Bumped also? Well, that includes all the tests that we got, which are from those physicians, and some tempest physicians that were added towards the late of the last quarter.
Arthur He: So, they're coming from that group. Now, we did grow the number of physicians. We started with 10 and we've been slowly growing at out, and so there are more physicians being added, not particularly great clip, but that's what that is.
Arthur He: Gotcha, thanks for the comments. And my second question is, so regarding the razor guidance, for the regarding revenue, it's in the coming morph on the farmer testing business, I just curious, is these driven more by the IND service, or there's some interest in the next person though, thrown the farmer? So, it's actually both. So, most of the revenue today is from ImmunoID next. The pharmaceutical business has been very, very strong over the last few quarters in Q2, especially. The pipeline for next personal with our biopharma customers is growing rapidly, and so we're going to start to see that start to take up over the next few quarters here as we go forward.
Arthur He: Gotcha, that's good here. And the last question is, so for the next person though, what's your plan when you're looking beyond the breast cancer lung cancer and IO therapy monitoring? What's the potential beyond that? We haven't really stated anything beyond that. Just yet Arthur, so right now we're focused on these cancer types. It's close to half of the market, it's going to give us plenty of things to keep us busy with over the next couple of years. So, right now we're hunkered down and focused on these cancer types too.
Arthur He: Gotcha, thanks Aaron. And thanks for taking my question.
Daniel Brennan: We have another question from Dan Brennan from Phoebe Cohen. Hey, it's John from Dan. So it was really nice revenue performance from the quarter at 226, which is one your way to the run rate to hit the 100 million in 2025 levels.
Daniel Brennan: So it's to get closer, can you just share some thoughts about how you're feeling about achieving this milestone, especially with Nutera, business rolling off, and be great if you could kind of walk through expectations for a different revenue bucket in terms of like MRD vaccines and a prize and VIA. Sure, great. Thanks for the question. In terms of looking ahead into 2025, we haven't given specific guidance to the buildup of it, but the way to look at it.
Daniel Brennan: So in Chris' prepared remarks, he talked about the enterprise work with Nutera ending by the end of this year. So we can assume, and you folks can assume that there's going to be zero from Nutera in 2025. We're going to have about $22 million in $24 from Nitarra. You could assume most of that is going to be offset by our Biopharma increase. Biopharma will increase from not only Immune ID next, but also next personal.
Daniel Brennan: Again, the funnel is blowing immensely. We're expecting that to start to take up your over the next few quarters. In addition, we're also engaged in looking for additional enterprise. The enterprise type of work, and so we're optimistic that there could be something in the horizons as well. The VAMVP might be $78 million, so if you assume the current rent rate there, it's going to be flat. But most of the buildup growth is going to cut from Biopharma.
Daniel Brennan: And then it would be great to get a little more color on the myriad deal. This is what we're both personnel. I'm looking to get out of the agreement and then maybe in the end of like, it seems personnel is kind of changing its IP strategy from one where you were previously enforcing your patents. And now it seems like you're sharing your IP with the area and settling the foresight. I think it's all about patient access and having a model that is comprehensive and large and helps all build the market.
Daniel Brennan: But in a way that actually you want to create value for the IP. So in the case of myriad, they had a lot of depoundational work there. And by doing the cross license deal, we give each other, you know, make sure that we each other can move in a way that we both have freedom to operate. And I think that's really good for both companies for shareholders and for patients and doctors and as a way for us to be appropriately spending money in the case of foresight.
Daniel Brennan: And there's some great IP and we end up with royalties there and moving forward. You know, we'll continue to find ways to bring value for the IP that we've developed. Got it. Thanks. There are no further questions at this time.
Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask if you please disconnect your line. Goodbye.
Operator: Have a good one.