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| Statement |
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| In the meantime, customers continue to be successful in obtaining and using PLA codes to get reimbursement for OGM applications |
| 2023 was one of the Bionano’s most successful years ever, with solid revenue growth and achievement of all our publicly stated Elevate milestones |
| And so the flexibility in the workflow, coupled with the higher throughput is something that labs are finding very interesting and very attractive |
| And so, we feel like we’ve created a really solid momentum for those studies, and it’s going to be fine to let them sort of filter into the market |
| Despite the challenging backdrop from macroeconomic headwinds facing the industry overall, we believe 2023 set the stage for a bright future for OGM and the impact our products can make in healthcare |
| And so we were pleased to see that an application for a CPT code has been made this year |
| So, super pleased about that |
| But I think that the clinical trials program had developed such incredible momentum that a lot of the work will continue independently of our efforts |
| The Stratys System increases the throughput of OGM data generation by as much as fourfold compared to the Saphyr System and we have a roadmap to further increase that throughput over time |
| And we feel confident about this 80 to 100 new installs |
| And we’ll maintain our very successful focus in Europe and United States, and Canada |
| So, we’ve really made tremendous progress across all areas, perhaps with the exception of solid tumor, although we have the study, which has been IRB approved, and we’re really waiting to just, actually have really more bandwidth to spend time on that particular study |
| In both prenatal and postnatal, we had landmark publications that came out over the course of the year, in 2023, really demonstrating the concordance with traditional methods and beginning to show some of the incremental benefits in diagnostic yield, especially for the postnatal study |
| We saw substantial increase in OGM publications in 2023, with over 5,000 clinical genomes published and the highest recorded quarter-to-date, with 88 publications in the fourth quarter of 2023 |
| Our installed base of optical genome mapping system grew by $25 from the third to the fourth quarter of 2023 for a total of $326 on December 31, 2023 which reflects a 36% increase from year end 2022 |
| And so we’re hopeful of a good outcome towards the end of the second quarter, 2024 |
| Full year 2023 total gross margin was 26%, up from 21% in full year 2022 |
| As we streamline our operating structure, we believe we are cementing the path forward now |
| Stratys was released in an early access program in Q4 and demand exceeded our planned supply of 10 systems |
| There are also other characteristics of the Stratys System that make it attractive to users, which include really a lot of flexibility coming to introducing samples into the system and generating data |
| 2023 revenue totaled $36.1 million, which reflects an increase of 30% over 2022 revenue |
| We sold 7,980 flowcells in the quarter, which reflects 67% growth over Q4 2022 |
| And for a while now, we have seen a very rough 50-50 distribution, but we are actually seeing a little bit more of purchases with Stratys and that’s encouraging |
| So just because of that, I think there will be an improvement |
| Regarding operating expense, GAAP gross margin for the fourth quarter of 2023 was 23%, which is slightly higher than the 22% GAAP gross margin reported for the fourth quarter of 2022 |
| The other the other reason is that, as important as that product flow is, and the samples coming in the door, and, they provide some benefit to the advancement of OGM overall, they’re not really core |
| And as has been pointed out, as we discussed, these steps with our incredible employees |
| For the full year, we sold 72% growth in the number of flowcells sold from 2022 to 2023, with a total of 26,444 |
| Consistent with our pre-announcement in January, Q4 revenues were $10.7 million, which is up 30% versus Q4 2022 |
| We expect utilization to increase even more as the higher throughput Stratys System becomes a larger percentage of our total installed base |
| Statement |
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| And as you can imagine, it’s such a difficult decision to make to reduce these costs, those that that sort of magnitude exceeds a third of the company |
| Reducing expenses is a difficult, but important step in addressing our financing overhang |
| So, I think in contrast to prior years, where Bionano has led the process to apply for the CPT code, I think what we learned in that process is that as the manufacturer of the technology, it’s difficult for us to really provide the information |
| And they’ve been growing a little bit |
| Our core product development is mostly completed and we are targeting segments of the genome analysis market, where we believe we face no direct competition, seeking to replace the course of classical cytogenetic methods, with a single essay, in contrast to the sequencing and spatial genomics markets, which have become incredibly crowded |
| This growth is important to note as we believe it indicates higher consumables utilization given that consumables growth is outpacing installed base growth by a factor of two |
| As part of that streamlining, however, we have made the difficult decision to phase out some of our clinical services products that we sell directly to physicians, namely our First Step and Next Step DX products and our Fragile X Test, which are legacy non-OGM tests |
| And our experience when we did reductions in the fourth quarter was that for a variety of reasons, a few people here and there had to be taking in and move out of the plan |
| And one of the reasons that we decided to discontinue the services products was that there are a fair number of people associated with generating those revenues |
| And so, essentially, all areas of the company will be impacted |
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