Continued sales growth and several commercial agreements signed!
SEK t | Q2 23/24 | Q2 22/23 | May-Oct 23/24 | May-Oct 22/23 | Full year 22/23 |
Net sales | 2,563 | 961 | 4,316 | 1,506 | 3,383 |
Operating profit (loss) | -25,316 | -23,310 | -57,508 | -43,973 | -110,457 |
Profit (loss) for the period | -25,684 | -23,250 | -57,949 | -44,254 | -110,492 |
Earnings per share, after dilution | -0.56 | -0.81 | -1.27 | -1.55 | -3.17 |
Number of shares at the end of the period | 45,741,394 | 28,573,372 | 45,741,394 | 28,536,089 | 34,828,207 |
Cash and cash equivalents at the end of the period | 46,932 | 46,997 | 46,932 | 46,997 | 114,327 |
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 inFlorida - DiviTum® TKa to pursue Gap-fill process for CMS pricing decision
Biovica signs second agreement with largest healthcare provider inMissouri Biovica signs US agreement with leading healthcare provider inArizona Biovica announces the start of a prospective DivTum® TKa clinical trial in partnership withYale 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
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
Our team in the
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
We are also delighted by the enthusiasm we are seeing from oncologists who keep ordering the assay via our CLIA lab in
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,
We previously communicated that our goal is to have an average price of
CMS decided that DiviTum TKa will be able to use the crosswalk process to link a price to our PLA code, effective
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
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
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
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
With great optimism for the future, I will myself be subscribing for
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