FDA Appoved Biovica gets Medicar reimbursment code Very positive
Biovica, active in cancer monitoring, today announces that the company has received a PLA code from the AMA (American Medical Association), an important milestone in the commercialization of DiviTum® TKa in the United States.
The PLA code is a specific code for the DiviTum® TKa test issued by the AMA and enables payers and providers to readily identify our service and reduce administrative burden for providers and payers. Effective October 1, 2023, the code will be used for billing, reporting, and processing healthcare claims.
“We are happy that we have received the PLA code from the AMA. This means that our process of pricing determination for Medicare is referenced by government and commercial payers in the US during the contracting and claims processes,” says Warren Cresswell, President Biovica Americas. “This is important for patients, as some 50 percent of women with this type of breast cancer are Medicare Beneficiaries.”
Our take:
Medicare is the largest insurer in the US with around half patients being covered by it. The sales should accelerate in the coming quarters.
The PLA code is a specific code for the DiviTum® TKa test issued by the AMA and enables payers and providers to readily identify our service and reduce administrative burden for providers and payers. Effective October 1, 2023, the code will be used for billing, reporting, and processing healthcare claims.
“We are happy that we have received the PLA code from the AMA. This means that our process of pricing determination for Medicare is referenced by government and commercial payers in the US during the contracting and claims processes,” says Warren Cresswell, President Biovica Americas. “This is important for patients, as some 50 percent of women with this type of breast cancer are Medicare Beneficiaries.”
Our take:
Medicare is the largest insurer in the US with around half patients being covered by it. The sales should accelerate in the coming quarters.
NordicGuy
24.07.2023 kl 15:30
1231
Biovica - one of the most interesting companies in Scandi pharma sector - NOTES FROM THE CALL WITH THE MGMT FROM LAST WEEK- LATEST UPDATE:
Biovica has the first ever FDA approved biomarker test for breast cancer.
Bloomberg: Biomarker testing will change the way cancer is treated. Biovica should be the main beneficiary.
Sales should exceed USD 100 million according to Pareto.
NOTES FROM THE CALL WITH THE MGMT FROM LAST WEEK- LATEST UPDATE:
https://fitinvestmentideas.com/
Biovica has the first ever FDA approved biomarker test for breast cancer.
Bloomberg: Biomarker testing will change the way cancer is treated. Biovica should be the main beneficiary.
Sales should exceed USD 100 million according to Pareto.
NOTES FROM THE CALL WITH THE MGMT FROM LAST WEEK- LATEST UPDATE:
https://fitinvestmentideas.com/
NordicGuy
25.07.2023 kl 12:42
1184
Biovica just posted on their social media a link to a blog post with the following wording:
Hot off the press! "Biovica is one of the most interesting companies in Scandinavian pharma sector" blog post. The DiviTum® TKa test is an FDA-cleared biomarker test for metastatic breast cancer monitoring. Link to the post:
https://loom.ly/EEj5TDE
Hot off the press! "Biovica is one of the most interesting companies in Scandinavian pharma sector" blog post. The DiviTum® TKa test is an FDA-cleared biomarker test for metastatic breast cancer monitoring. Link to the post:
https://loom.ly/EEj5TDE
NordicGuy
26.07.2023 kl 10:34
1137
The CEO invested 1 million EURO in the last capital raise last year. I do not know any other CEO in Sweden, who would put so much money into his company. Very positive sign of confidence.
NordicGuy
26.07.2023 kl 15:02
1110
I asked chatGPT why is obtaining PLA code from Medicare important :
The obtaining of a Medicare PLA (Physician Fee Schedule Procedure-to-Procedure Edits "Column One/Column Two Correct Coding Edits") code can potentially affect the share price of a pharmaceutical company that receives it in a few ways:
1. **Increased Revenue Potential:** With a Medicare PLA code, the pharmaceutical company's drug or medical procedure becomes more accessible to Medicare beneficiaries. This could lead to higher sales volume and increased revenue, potentially positively impacting the company's financial performance and, in turn, investor confidence.
2. **Market Perception:** The granting of a Medicare PLA code may be perceived positively by investors and the market. It signals that the drug or procedure has met certain criteria for Medicare coverage, which could enhance the company's reputation and market position.
3. **Investor Confidence:** The approval of a Medicare PLA code can boost investor confidence in the company's ability to navigate regulatory processes successfully and expand market opportunities. This positive sentiment may attract new investors or increase interest from existing ones, influencing the share price.
4. **Competitive Advantage:** Having a Medicare PLA code for a drug or procedure can provide a competitive advantage over other companies that do not have the same coverage. This advantage could potentially lead to a larger market share and better financial performance, positively impacting the share price.
However, it's important to note that the impact on the share price is not guaranteed, and other factors can also influence the stock's performance. Investors consider a variety of elements, including the company's overall financial health, pipeline of drugs, competition, and macroeconomic trends when evaluating their investment decisions. While obtaining a Medicare PLA code can be beneficial, its effect on the share price is just one aspect to consider in the larger context of the company's operations and market conditions.
The obtaining of a Medicare PLA (Physician Fee Schedule Procedure-to-Procedure Edits "Column One/Column Two Correct Coding Edits") code can potentially affect the share price of a pharmaceutical company that receives it in a few ways:
1. **Increased Revenue Potential:** With a Medicare PLA code, the pharmaceutical company's drug or medical procedure becomes more accessible to Medicare beneficiaries. This could lead to higher sales volume and increased revenue, potentially positively impacting the company's financial performance and, in turn, investor confidence.
2. **Market Perception:** The granting of a Medicare PLA code may be perceived positively by investors and the market. It signals that the drug or procedure has met certain criteria for Medicare coverage, which could enhance the company's reputation and market position.
3. **Investor Confidence:** The approval of a Medicare PLA code can boost investor confidence in the company's ability to navigate regulatory processes successfully and expand market opportunities. This positive sentiment may attract new investors or increase interest from existing ones, influencing the share price.
4. **Competitive Advantage:** Having a Medicare PLA code for a drug or procedure can provide a competitive advantage over other companies that do not have the same coverage. This advantage could potentially lead to a larger market share and better financial performance, positively impacting the share price.
However, it's important to note that the impact on the share price is not guaranteed, and other factors can also influence the stock's performance. Investors consider a variety of elements, including the company's overall financial health, pipeline of drugs, competition, and macroeconomic trends when evaluating their investment decisions. While obtaining a Medicare PLA code can be beneficial, its effect on the share price is just one aspect to consider in the larger context of the company's operations and market conditions.
NordicGuy
27.07.2023 kl 16:00
1059
Biomarkers will change the way cancer is treated :
https://finance.yahoo.com/news/cancer-biomarkers-market-revenue-cross-121100497.html
https://finance.yahoo.com/news/cancer-biomarkers-market-revenue-cross-121100497.html
NordicGuy
31.07.2023 kl 12:35
929
Today - Another positive news from Biovica - Third commercial agreement in the US signed
Biovica has signed yet another commercial partnership like the previous two ones (MediNcrease and Contigo). Occum Health claims to have contracts with over 500 employers.
Biovica is making a positive announcement every week. The share price gains traction - it is up 30% since July 28. Trading at SEK 8.6. It is still 75% down from the average price before covid and well before all recent announcements.
Biovica has signed yet another commercial partnership like the previous two ones (MediNcrease and Contigo). Occum Health claims to have contracts with over 500 employers.
Biovica is making a positive announcement every week. The share price gains traction - it is up 30% since July 28. Trading at SEK 8.6. It is still 75% down from the average price before covid and well before all recent announcements.
NordicGuy
01.08.2023 kl 10:19
891
Bloomberg: Cancer Biomarkers Market Size Worth US$ ~31.7 billion by 2030: Exclusive Report by Growth Plus Reports
https://www.bloomberg.com/press-releases/2022-07-22/cancer-biomarkers-market-size-worth-us-31-7-billion-by-2030-exclusive-report-by-growth-plus-reports
https://www.bloomberg.com/press-releases/2022-07-22/cancer-biomarkers-market-size-worth-us-31-7-billion-by-2030-exclusive-report-by-growth-plus-reports
NordicGuy
03.08.2023 kl 10:53
859
Great momentum - up 80% in the last two weeks. One of the best stocks in Sweden in the last two weeks.
If you look at the market capitalization graph in the SeekingAlpha article on Biovica - It is still in the early innings. Multiple times below its valuation before Covid delayed the FDA approval.
Now fully FDA approved with a contract with Medicare that covers 50% of US breast cancer patients and the remaining 50% covered by Biovica´s contracts with large US insurers, Biovica should trade much higher than it did before covid (before FDA approval.
https://seekingalpha.com/article/4584325-biovica-fda-approved-breast-cancer-test-can-detect-tumor-progression-60-days-earlier-than-imaging
If you look at the market capitalization graph in the SeekingAlpha article on Biovica - It is still in the early innings. Multiple times below its valuation before Covid delayed the FDA approval.
Now fully FDA approved with a contract with Medicare that covers 50% of US breast cancer patients and the remaining 50% covered by Biovica´s contracts with large US insurers, Biovica should trade much higher than it did before covid (before FDA approval.
https://seekingalpha.com/article/4584325-biovica-fda-approved-breast-cancer-test-can-detect-tumor-progression-60-days-earlier-than-imaging
NordicGuy
04.08.2023 kl 14:42
820
Medicare contract doubled Biovica's share price. The next big catalyst should be a contract with US hospitals or hospital chains. Such news could easily double the share price again.
Biovica had a good run the last two weeks. But BIovica's market capitalization is still 80% below the levels before Covid (before all successes Biovica achieved since gaining FDA approval late last year.
The share price is 9.5 SEK today. It could easily beat low 20s after the first larger hospital deal is announced.
Biovica has material upside optionality.
Biovica had a good run the last two weeks. But BIovica's market capitalization is still 80% below the levels before Covid (before all successes Biovica achieved since gaining FDA approval late last year.
The share price is 9.5 SEK today. It could easily beat low 20s after the first larger hospital deal is announced.
Biovica has material upside optionality.
NordicGuy
07.08.2023 kl 12:08
764
Biovica is consolidating after stong run. Contract with US hospitals should be next big driver up. COuld happen any day or week
NordicGuy
10.08.2023 kl 10:39
693
Today announvement by Biovica:
Biovica - Material Revenue Comming from Pharma Collaborations and Companion Diagnostics (CDx) for Specific Drugs
THERE IS ENORMOUS POTENTIAL IN BEING ABLE TO SELL THE ASSAY AS A COMPANION DIAGNOSTIC TO ONE OF THE CANCER DRUGS THAT IS CURRENTLY UNDER DEVELOPMENT.
WE ARE CURRENTLY IN 17 PROJECTS WITH DIFFERENT PHARMA COMPANIES IN DIFFERENT STAGES.
CDX SHOULD BE A MAJOR BUSINESS LINE FOR BIOVICA IN THE COMING YEARS.
Full post:
https://biovica.com/who-we-help/#pharma
Biovica - Material Revenue Comming from Pharma Collaborations and Companion Diagnostics (CDx) for Specific Drugs
THERE IS ENORMOUS POTENTIAL IN BEING ABLE TO SELL THE ASSAY AS A COMPANION DIAGNOSTIC TO ONE OF THE CANCER DRUGS THAT IS CURRENTLY UNDER DEVELOPMENT.
WE ARE CURRENTLY IN 17 PROJECTS WITH DIFFERENT PHARMA COMPANIES IN DIFFERENT STAGES.
CDX SHOULD BE A MAJOR BUSINESS LINE FOR BIOVICA IN THE COMING YEARS.
Full post:
https://biovica.com/who-we-help/#pharma
NordicGuy
28.08.2023 kl 17:10
577
New study at Yale!
New clinical trial initiated for DiviTum’s long-term growth potential
Biovica announced that it has initiated a clinical trial in the US with Yale Cancer Center to study the correlations between DiviTum measured TKa levels and the impact of medication dose reductions in metastatic breast cancer care. In addition, TKa levels will also be analyzed for correlation with improved CDK4/6 inhibitor responses, duration on therapy and outcomes. The study plans to enroll 120 patients with a duration of 12-18 months – which is likely yielding results in 2H 2025 / 1H 2026. If successful, the results could install TKa measurement as a standard component in CDK4/6 treated patients. We have a Buy rating on BIOVIC with a target price of SEK 32.
Biovica announced that it has initiated a clinical trial in the US with Yale Cancer Center to study the correlations between DiviTum measured TKa levels and the impact of medication dose reductions in metastatic breast cancer care. In addition, TKa levels will also be analyzed for correlation with improved CDK4/6 inhibitor responses, duration on therapy and outcomes. The study plans to enroll 120 patients with a duration of 12-18 months – which is likely yielding results in 2H 2025 / 1H 2026. If successful, the results could install TKa measurement as a standard component in CDK4/6 treated patients
New clinical trial initiated for DiviTum’s long-term growth potential
Biovica announced that it has initiated a clinical trial in the US with Yale Cancer Center to study the correlations between DiviTum measured TKa levels and the impact of medication dose reductions in metastatic breast cancer care. In addition, TKa levels will also be analyzed for correlation with improved CDK4/6 inhibitor responses, duration on therapy and outcomes. The study plans to enroll 120 patients with a duration of 12-18 months – which is likely yielding results in 2H 2025 / 1H 2026. If successful, the results could install TKa measurement as a standard component in CDK4/6 treated patients. We have a Buy rating on BIOVIC with a target price of SEK 32.
Biovica announced that it has initiated a clinical trial in the US with Yale Cancer Center to study the correlations between DiviTum measured TKa levels and the impact of medication dose reductions in metastatic breast cancer care. In addition, TKa levels will also be analyzed for correlation with improved CDK4/6 inhibitor responses, duration on therapy and outcomes. The study plans to enroll 120 patients with a duration of 12-18 months – which is likely yielding results in 2H 2025 / 1H 2026. If successful, the results could install TKa measurement as a standard component in CDK4/6 treated patients