Biovica submitted its application to the FDA. The probability of the approval is very very high – FDA requested just one additional information that Biovica now submitted. I expect FDA approval by end of June. The share price could easily double on the approval. Yesterday Biovica presented its team that is working on the product lunch. The team is very impressive. Do watch the presentation.
The FDA approval is the major catalyst. The stock is hammered by the FDA approval delay caused by Covid FDA congestion. The stock should easily double from the current levels upon the FDA approval.
The most impressive part of the presentation was the composition of the Biovica team working on the lunch. I included a few. They were quite impressive. Looks like Biovica management is well positioned for a lunch of the DiviTum
Warren Cresswell, President of the Americas
- 25-years of Diagnostic Experience in Medical Device (IVD 510(k) & PMA), CLIA Lab (LDT), and Pharma
- Built Dx Orgs, Developed & Launched High Value Multi -Analyte Algorithm Based Dx Assays, and Implemented Effective Reimbursement Strategies
- Executive Leadership, Commercial, BD& Operations
Kendon Richards, Executive Director of Sales
- 25+ years of Pharmaceutical and Specialty Diagnostic Experience
- Built Pharma and Dx Sales Orgs, Successfully launched 15 products (8 in
the Specialty Dx space), Led Salesforce Integration and Implementation of Effective Reimbursement Strategies - National Sales Leadership, National Accounts Leadership and Marketing Brand Team Member
Amy Williams, PhD, Head of Clinical Development and Medical Affairs
- PhD in Pathology from Boston University School of Medicine
- 20+ years of experience in oncology drug development – from discovery through launch and beyond
- Most recent experience with Novartis Oncology, Breast Cancer Team
- Supported Femara, Zometa, Afinitor, Piqray, Kisqali, etc
Mattias Bergqvist, Clinical Development Director
- 10 years at Biovica as Clinical Development Director
- 5 years at AstraZeneca, Therapy Area Director Oncology Nordics, Global Brand Manager Breast Cancer
- Responsible for directing ex-US clinical trial program
Henrik Winther, DVM, PhD
- SVP Business Development & Pharma Collaborations
- 20+ years in the in vitro diagnostic (IVD) society bringing biomarker assays into the clinical routine market and with managing roles within R&D and BD.
- Special passion and general manager roles within the Companion Diagnostic (CDx) field and collaborations with Pharma
- Design responsible for the first global market CDx assay (HercepTestTM)
- Responsible for the development, registration and commercialization of the Keytruda and Opdivo CDx’s (one true CDx and one Complementary Diagnostics)
Link to all presentations from the capital mks day:
Link to the webcast:
https://tv.streamfabriken.com/biovica-international-cmd-2022
ABG Sundal Collier summary
Takeaways from Capital Markets Day Commissioned research:
Demand generation important for CLIA lab strategy
Multiple angles to market the product
US launch will follow after 510(k) decision
Updated CLIA lab go-to-market strategy
During its CMD yesterday, Biovica updated the market on its planned goto-market strategy, which is now focused on establishing a CLIA lab. In
our view, the important factor is to establish awareness and convince
KOLs, and Biovica is currently building its sales organization to do this.
This model will provide a direct relationship with all the relevant
stakeholders, (patients, physicians & payers), which we believe could
prove beneficial to optimize its offering to facilitate uptake. We believe
standardized reimbursement coverage will be important for broader use,
but the company will enter the market with a combination of hospital
contracting, insurance and co-pay initially.
Multiple pathways to position DiviTum
Biovica has developed a broad base of clinical evidence, and this creates
multiple potential pathways to position DiviTum in the market. One such
pathway is to stratify patients to design treatments, on the back of the
prognostics value it has shown at baseline measurement. Another area is
to confirm treatment response or alter non-responding treatments
through continuous monitoring, on the basis of the different TKa patterns
identified from continuous monitoring. Supported by the budget impact
model, Biovica will initially position DivTum towards cost savings, but as
usage increases it would also like to establish a benefit in improving
clincal outcomes.
510(k) resubmitted, clearance decision within months
Looking forward, the key milestone is achieving the long-awaited 510(k)
clearance, after which Biovica will launch the product in the US. The
updated application was submitted on 28 April and under the regular
review times a potential clearance decision should be given within 1-2
months from that date. We believe the uncertainty surrounding the
response time from the FDA continues to be elevated, although it is our
impression that the situation has improved as the COVID burden is now
easing.
Link to the ABG Research:
Disclosure:
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
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