Biovica International

Significant events during the second quarter

• CAP accreditation obtained for the Biovica CLIA laboratory in San Diego
• Biovica signs agreement for DiviTum® TKa with world-renowned cancer clinic in Florida
• DiviTum® TKa to pursue Gap-fill process for CMS pricing decision
• Biovica signs second agreement with largest healthcare provider in Missouri
• Biovica signs US agreement with leading healthcare provider in Arizona
• Biovica announces the start of a prospective DivTum® TKa clinical trial in partnership with Yale Cancer Center
• Resolution by the Board to conduct a rights issue of SEK 120 million
• Summons to extraordinary general meeting on 23 November

Significant events after the end of the period

• CMS decides on price for DiviTum TKa for Medicare in USA
• Biovica signs commercial partner for the DiviTum® TKa assay in the Nordics
• Resolution on rights issue passed at the extraordinary general meeting on 23 November 2023

Webcast:
When: 28/11 2023 kl. 15.00 CET
Where: register via lyyti: https://www.lyyti.fi/reg/Biovica_Q2_Earnings_call_2023__Live_Event_2257
Broadcast language: in English

CEO’s comments

We made progress during the quarter in all three of our priority areas, which are the USA, Europe and collaboration with pharmaceutical companies. Our focus remains on commercial activities, and we take great pride in witnessing the myriad advantages that DiviTum TKa brings to various stakeholders, including payers, pharmaceutical companies, and most importantly, the patients whose lives are positively impacted.

Our work to sign contracts is progressing at a good pace and the agreed prices are in line with, or even above the expected levels. We have thus far announced the signing of three agreements with major hospital chains. They are with leading healthcare providers in the states of Arizona, Florida and Missouri. In total, these agreements cover approximately 50 hospitals.

Our team in the USA has been very busy and we anticipate that there will be ten agreements signed with major hospital chains by the end of the financial year, in line with what we have previously communicated.

The agreements are very important, since they facilitate being able to offer DiviTum TKa to patients who are being treated for their cancer. They also generate revenue for Biovica.

We are also delighted by the enthusiasm we are seeing from oncologists who keep ordering the assay via our CLIA lab in San Diego. They have been placing regular orders and many are even increasing the frequency of their orders.

The process of getting reimbursed from private insurance providers became further simplified during the quarter when our CLIA lab obtained CAP accreditation, which is verification of meeting the important standards on patient care and safety. It’s a great achievement for our lab team!
Since 1 October, Biovica has had a specific PLA code that is used by payers and suppliers for invoicing, reporting and processing of healthcare claims for our assay. The code is very important, since it is a prerequisite for becoming established in the US payment system.

We previously communicated that our goal is to have an average price of USD 400 per assay in the US market. The decision from CMS issued in mid-November indicates that our chances of reaching that level or an even higher level are very good!

CMS decided that DiviTum TKa will be able to use the crosswalk process to link a price to our PLA code, effective 1 January 2024. We regard this as very good news, since it shortens the processing time by a full year and also removes uncertainty about the pricing of our assay.

The clinical use of the test is being bolstered by positive studies. Two important studies investigating the clinical utility of DiviTum TKa are TK IMPACT (currently underway at Washington University) and a study that got underway this quarter at Yale Cancer Center. A summary from both studies will be presented as posters in December at San Antonio Breast Cancer Symposium (SABCS), which is the world’s largest breast cancer symposium.

Thus far in the TK IMPACT study, we have evidence that DiviTum TKa has been able to improve patient monitoring compared to the current standard. If the study continues in this direction and there is a successful outcome, it will significantly strengthen Biovica’s argument for inclusion of the assay in guidelines and payment systems.

One clear trend we are seeing is that there is demand from oncologists for biomarkers that give them feedback on whether the treatment they are administering is effective, since this is obviously very important for the patient. It is a trend that is gaining even more momentum because of Project Optimus. It is an initiative by the FDA to reform dose optimization and selection paradigm in oncology drug development, with a shift from maximum tolerated dose to minimum effective dose. This is fueling an even greater need for good biomarker assays that can be used to evaluate treatment effect, which is precisely what DiviTum TKa is.

In Europe, our goal for quite some time has been to sign partnership agreements with the five largest, most populous countries in the EU (Italy, Spain, Germany the UK and France) plus the Nordics. We have already achieved that in Italy and our progress with negotiations indicates that we will have another agreement signed by the end of the fiscal year. Our partnership agreements in Europe give us access not only to a sales force, but also laboratories that perform analyses.

Subsequent to the end of the period, we signed a commercial partnership agreement for the Nordics with Axlab, which is one of the leading companies for cancer screening and diagnostics in the Nordics. Axlab has an excellent network in the field of oncology, as well as extensive experience in oncology healthcare processes. They currently have 22 individuals in their oncology sales force but will be recruiting two more in conjunction with signing the agreement with Biovica, which makes us very enthusiastic about the collaboration.

Three new projects started up during the period, which means that we now have 19 ongoing projects for collaboration and sales to pharmaceutical companies that are developing new cancer drugs. We have established ourselves as an important partner to, above all, pharmaceutical companies that are developing new CDK inhibitors. It is an impressive achievement by our team, which fills me with optimism about the future. We anticipate that revenue will continue to rise during the current financial year, which increases our confidence in being able to sign our first agreement for a Companion Diagnostic (CDx) development project in the near future.

An EGM was held subsequent to the end of the quarter, where it was resolved that the company would carry out a new issue, which will give the company the funds it needs to reach the point where it is cash flow positive around the middle of the 2025 calendar year when the forecast for quarterly sales is around SEK 50 million.

With great optimism for the future, I will myself be subscribing for SEK 10 million in shares.

Anders Rylander, CEO