Interim / Quarterly Report • Sep 2, 2021
Interim / Quarterly Report
Open in ViewerOpens in native device viewer
TREATMENT DECISIONS FOR PATIENTS ACROSS THE GLOBE
m
Kinish
A revolutionary, fully automated system that makes molecular testing convenient and exceptionally fast. Suitable for any lab.
| $\mathbf{1}$ | Message from the CEO | |
|---|---|---|
| 2. | Responsibility statement | |
| 3. | Business review of the first half of 2021 | |
| 4. | Principal risks related to the business activities | |
| 5 1 | Condensed consolidated interim financial statements for the period ended 30 June 2021 | |
| 6. | Notes to the condensed consolidated interim financial statements | |
| 7. | Review report of the auditor | |
| 8. | Disclaimer and additional information | |
| 9. | Glossary |
Dear Shareholder. Dear Stakeholder,
After the very strong performance in H1 2021, both in terms of instrument placements as well as commercial cartridge volumes, the fire was obviously an unfortunate set-back. Although we cannot deny the fire has an impact, this event again showed the incredible resilience of our teams who have been working with relentless focus and dedication to limit the fall-out.
I am proud to announce that we currently expect a smooth restart of the ML2 line by the second half of September 2021. This is also important considering the recent launch of the Idylla™ SARS-CoV-
2/Flu/RSV Panel, the upgrade of our existing Idylla™ SARS-CoV-2 Test (CE-IVD) that now also includes Flu A/B and RSV. Ahead of a delayed flu season, this Panel is well positioned to quide healthcare providers in this complex landscape of respiratory infections in 2022.
Furthermore, I am very excited to announce a possible break-through in our cartridge manufacturing with the ongoing evaluation of a new simplified, cost-efficient cartridge design which is expected to significantly lower manufacturing costs for a selection of our Idylla™ assays. Together with the ongoing development of a new technology on Idylla™ which aims to personalize Idylla™ assays while reducing development time and cost, this could prove to be a pivotal development towards sustainable growth in the years to come."
Herman Verrelst CFO Biocartis
The undersigned hereby declare that to the best of their knowledge: a) the condensed consolidated interim financial statements for the six-months' period ended 30 June 2021, which have been prepared in accordance with IAS 34 'Interim Financial Reporting' as adopted by the European Union, give a true and fair view of the net equity, financial position and results of the Company and the companies included in the consolidation, and b) give a true and fair view of the main events and the impact thereof on the condensed consolidated interim financial statements c) give a true and fair view of the main risks and uncertainties with respect to the remaining months of the fiscal year, and the main transactions with related parties and the impact thereof on the condensed consolidated interim financial statements.
Herman Verrelst CEO
Christian Reinaudo Chairman
Robust growth in oncology across all regions: solid contribution from infectious diseases, comparable to the H2 2020 volumes against the backdrop of declining global COVID-19 testing volumes.
189 new Idylla™ placements in H1 2021 (101 in H1 2020) mainly driven by demand in European and distributor markets as well as by content partners;
Expanded partnership with AstraZeneca announced to improve access to rapid and easy-to-use Idylla™ EGFR testing products at selected hospital sites in European and global distributor markets.
Total operating income amounted to EUR 23.1m compared to EUR 17.1m last year;
1 Defined as the world excluding European direct markets, U.S. China and Japan
2 During Q1 2021, the Idyllane platform, the Idyllane BRAF Mutation Test (CE-IVD) and the Idyllane EGFR Mutation Test (CE-IVD) completed registration in Russia, and the Idyllane MSI Test (CE-IVD) completed registration in Taiwan, as such expanding the commercial footprint for Biocartis' IVD medical devices. Post the reporting period, additional registrations were also completed in Taiwan
3 In China, Biocartis established a joint venture ('China JV') with Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a fast-growing diagnostics leader in China. In Japan, Biocartis is collaborating with Nichirei Bioscience 4 RUO = Research Use Only, not for use in diagnostic procedures
4 ROO – Research Ose Only, not for use in diagnostic procedures
5 Biomarkers including gene fusions involving ALK1, ROS1, RET, NTRK1-2-3 as well as MET exon 14 skipping
6 Stransky et al. The landscape of kinase fusions in 381 2015
دمة, حاضر) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial approvals-denials-and-clearances, last consulted on 17 distribution for the first time. Source: https://www.fda.gov/medical-devices/products-and-medical-procedures/device August 2021
8 MSI or Microsatellite Instability is the result of inactivation of the body's so-called DNA mismatch repair (MMR) system, which normally spontaneously corrects errors that occur during DNA replication
9 Flanders government agency for Innovation & Entrepreneurship
including the publication of two studies10 by Memorial Sloan Kettering Cancer Center ('MSKCC', New York, US) concluding that Idylla™ EGFR testing (RUO) enables rapid assessment of the most common EGFR mutations with low sample input, even on different sample types, without compromising subsequent more comprehensive NGS11 testing, which can be useful in cases where EGFR mutation results were negative and further testing is needed. One abstract12 was presented at the ASCO Annual Meeting taking place virtually between 4-8 June 2021. One abstract on the SeptiCyte® RAPID on Idylla™ was presented at the 31st ECCMID (European) Congress $\Omega$ f Clinical Microbiology $\mathcal{R}_{\mathcal{L}}$ Infectious Diseases) congress (9-12 July 2021).
10 Arcila ME, Yang S-R, Momeni A, Mata DA, Salazar P, Chan R, Elezovic D, Benayed R, Zehir A, Buonocore DJ, Rekhtman N, Lin O, Ladanyi M, Nafa K, Ultra-Rapid EGFR Mutation io According Followed by Comprehensive Next-Generation Sequencing: A Feasible, Informative Approach for Lung Carcinoma Cytology Specimens with a High Success Rate., JTO Chical and Research Reports (2020), doi: https://doi. Mol Diagn 2020, Published on 23 December 2020, 1-12; https://doi.org/10.1016/j.jmoldx.2020.11.009 11 Next Generation Sequencing
ment veneration sequencing
12 Behera et al. Circulating tumor DNA mutation as a prognostic marker in melanoma with brain metastasis. J Clin Oncol 39, 2021 (suppl 15; abstr e21560); Only the abstracts at the
12 Behera et al
13 To replace CRBA Management BV, permanently represented by Christian Reinaudo, as independent director of the Company
The tables below show an overview of the key figures and a breakdown of operating income for H1 2021 and H1 2020. Consolidated financial statements and accompanying notes are included in Biocartis' half-year 2021 report that is available here on the Company's website.
| Key figures (EUR 1,000) | H1 2021 | H1 2020 | % Change |
|---|---|---|---|
| Total operating income | 23,057 | 17,606 | 31% |
| Cost of goods sold | $-17,059$ | $-9,233$ | 85% |
| Research and development expenses | $-23,389$ | $-20,303$ | 15% |
| Sales and marketing expenses | $-7.740$ | $-7,931$ | $-2%$ |
| General and administrative expenses | $-7,935$ | $-6,491$ | 22% |
| Operating expenses | $-56,132$ | $-43,958$ | 28% |
| Operating result | $-33,075$ | $-26,352$ | 26% |
| Net financial result | $-4,249$ | $-5,129$ | $-17%$ |
| Share in the result of associated companies | $-101$ | $-195$ | $-48%$ |
| Income tax | 149 | 118 | 26% |
| Net result | $-37,276$ | $-31,558$ | 18% |
| Cash flow from operating activities | $-33.752$ | $-24,526$ | 38% |
| Cash flow from investing activities | $-2,087$ | $-1,028$ | 103% |
| Cash flow from financing activities | $-3,518$ | $-3,456$ | 2% |
| Net cash flow 1 | $-39,357$ | $-29,010$ | 36% |
| Cash and cash equivalents 2 | 84,905 | 149,674 | $-43%$ |
| Financial debt | 149,412 | 165.258 | $-10%$ |
1 Excludes the effect of exchange rate differences on the cash balances held in foreign currencies
2 Including EUR 1.2m of restricted cash in H1 2021 and H1 2020
| Operating income (EUR 1,000) | H1 2021 | H1 2020 | % Change |
|---|---|---|---|
| Collaboration revenue | 2,640 | 4.746 | $-44%$ |
| Idylla™ system sales | 3.715 | 1,837 | 102% |
| Idylla™ cartridge sales | 14.749 | 9.584 | 54% |
| Product sales revenue | 18,463 | 11.421 | 62% |
| Service revenue | 748 | 530 | 41% |
| Total revenue | 21,851 | 16.697 | 31% |
| Grants and other income | 1.206 | 909 | 33% |
| Total operating income | 23,057 | 17,606 | 31% |
| Product sales revenue (EUR 1,000) | H1 2021 | H1 2020 | % Change |
|---|---|---|---|
| Commercial revenue : | 18.441 | 10.491 | 76% |
| Research & development revenue | $\sim$ | 930 | -98% |
| Fotal product sales revenue | 18,463 | 11.421 | 62% |
The principal risks related to Biocartis' business activities are outlined in Biocartis' 2020 Annual Report, p.42-55 available on the Biocartis website here. In summary, the principal risks and uncertainties faced by Biocartis relate to strategic and commercial risks, operational risks, regulatory risks and financial risks. Except for the update on the impact of COVID-19, the impact of the fire incident of 30 July 2021 as described below, and the going concern described in note 6.4, the principal risks have not materially changed from the ones outlined in the 2020 Annual Report.
During the first half of 2021, the pandemic still impacted the ordinary course of business, but global cancer care started to normalize. Commercial cartridge volumes in oncology grew across all regions and the contribution from the IdvIIam SARS-CoV-2 test remained robust. As a consequence, product income strongly grew by 62% to EUR 18.5m from EUR 11.4m in H1 2020.
The pandemic however started to impact the supply of raw materials. As a result, production volumes in H1 2021 were lower than expected as the pandemic caused a global shortage of reagent supplies, impacting gross margin through higher cost of goods, which also included the effect of hiring additional staff in anticipation of increasing volumes in the second half of the year. Further information on the impact of COVID-19 on the Group's operations and its financial results can be found in sections 3 and 6.3.
After the fire that broke out at one of the warehouse facilities in Mechelen (Belgium) during the night of 30 July 2021, the Company has taken immediate actions to mitigate the loss of finished products and raw materials as well as the temporary unavailability of the high-throughput ML2 manufacturing line. Aiming to safeguard continued supply to customers as much as possible, actions included (i) the redirection of additional personnel and resources to the unaffected ML1 cartridge manufacturing line to temporarily increase production on this line, (ii) the placement of orders to replenish critical reagents lost in the fire from different suppliers to minimize production delay and (iii) the prioritization of oncology and partner project tests manufacturing. The latter consequently also reduces the Idylla™ SARS-CoV-2 testing volumes.
As a result, Biocartis is able to confirm a 40% cartridge volume growth target for 2021, however subject to the timely availability of reagent raw materials for Idylla™ cartridges in sufficient quantities and the full restart of the ML2 line, which is now expected by the 2nd half of September. Nevertheless, due to the already known delays in the supply of certain assay-specific reagents, certain products may still be temporarily unavailable to meet the entire customer demand and further mitigating action may be required after production resumes on ML2.
A further overview and description of risk factors that may affect the future operating and financial performance of Biocartis and the value of an investment in the Company's securities can be found in Biocartis' annual and half-year reports.
| For the 6 months ended | |||||
|---|---|---|---|---|---|
| In EUR 000 | Notes | 30 June 2021 | 30 June 2020 | ||
| Collaboration revenue | 6.5 | 2,640 | 4,746 | ||
| Product sales revenue | 6.5 | 18,463 | 11,421 | ||
| Service revenue | 6.5 | 748 | 530 | ||
| Total revenue | 21,851 | 16,697 | |||
| Other operating income | |||||
| Grants and other income | 6.6 | 1,206 | 909 | ||
| Total operating income | 23,057 | 17,606 | |||
| Cost of sales | 6.7 | $-17,059$ | $-9,233$ | ||
| Research and development expenses | 6.8 | $-23,398$ | $-20,303$ | ||
| Sales and marketing expenses | $-7,740$ | $-7,931$ | |||
| General and administrative expenses | 6.9 | $-7,935$ | $-6,491$ | ||
| Total operating expenses | $-56,132$ | $-43,958$ | |||
| Operating loss for the period | $-33,075$ | $-26,352$ | |||
| Financial expense | 6.10 | $-4,703$ | $-5.083$ | ||
| Other financial results | 6.10 | 454 | -46 | ||
| Financial result, net | $-4,249$ | $-5,129$ | |||
| Share in the results of joint ventures | $-101$ | $-195$ | |||
| Loss for the period before taxes | $-37,425$ | $-31,676$ | |||
| Income taxes | 149 | 118 | |||
| Loss for the period after taxes | $-37,276$ | $-31,558$ | |||
| Attributable to owners of the Group | $-37,276$ | $-31,558$ | |||
| Earnings per share | |||||
| Basic and diluted loss per share | 6.11 | $-0.65$ | $-0.56$ |
| For the 6 months ended | |||||
|---|---|---|---|---|---|
| In EUR 000 | Notes | 30 June 2021 | 30 June 2020 | ||
| Loss for the period | -37,276 | $-31,558$ | |||
| Other comprehensive income (loss), not to be reclassified to profit or loss: |
|||||
| Re-measurement gains and losses on defined benefit plan |
-449 | -83 | |||
| Income taxes on items of other comprehensive income |
112 | 28 | |||
| Other comprehensive gain (loss) for the year, that may be reclassified to profit and loss: |
|||||
| Exchange differences on translation of foreign operations |
152 | 86 | |||
| Total comprehensive loss for the period |
-37,461 | -31,527 | |||
| Attributable to owners of the Group | $-37.461$ | -31,527 |
| As of | ||||
|---|---|---|---|---|
| In EUR 000 | Notes | 30 June 2021 | 31 Dec 2020 | |
| Assets | ||||
| Non-current assets | ||||
| Intangible assets | 5,377 | 5,645 | ||
| Property plant and equipment | 6.12 | 38,381 | 40,098 | |
| Financial assets | 6.13 | 1,140 | $\Omega$ | |
| Investment in joint ventures | 2,871 | 2,893 | ||
| Other non-current assets | 13 | 426 | ||
| Deferred tax assets | 1,437 | 1,472 | ||
| 49,219 | 50,534 | |||
| Current assets | ||||
| Inventories | 17,544 | 15,712 | ||
| Trade receivables | 12,015 | 13,488 | ||
| Other receivables | 6.14 | 4,865 | 3,960 | |
| Other current assets | 2,064 | 3,155 | ||
| Cash and cash equivalents* | 84,905 | 123,668 | ||
| 121,393 | 123,668 | |||
| Total assets | 170,612 | 210,517 | ||
| Equity and liabilities | ||||
| Capital and reserves | ||||
| Share capital | $-220,657$ | $-220,657$ | ||
| Share premium | 711,874 | 711,874 | ||
| Share based payment reserve | 6,512 | 6,102 | ||
| Accumulated deficit | $-492,467$ | $-455343$ | ||
| Other comprehensive income | $-5,489$ | $-5,152$ | ||
| Total equity attributable to owners | ||||
| of the Group | $-227$ | 36,824 | ||
| Non-current liabilities | ||||
| Provisions | 30 | $\circ$ | ||
| Borrowings and lease liabilities | 6.15 | 16,221 | 18,625 | |
| Convertible debt | 6.15 | 126,675 | 125,260 | |
| Deferred income | 6.16 | 338 | 363 | |
| 143,264 | 140,248 | |||
| Current liabilities | ||||
| Borrowings and lease liabilities | 6.15 | 6,516 | 6,673 | |
| Trade payables | 11,864 | 13,907 | ||
| Deferred income | 6.16 | 1,932 | 1,278 | |
| Other current liabilities | 7,263 | 7,587 | ||
| 27,575 | 29,445 | |||
| Total equity and liabilities | 170,612 | 210,517 |
| For the 6 months ended | ||||
|---|---|---|---|---|
| In EUR 000 | Notes | 30 June 2021 | 30 June 2020 | |
| Operating activities | ||||
| Loss for the period | $-37,276$ | $-31,558$ | ||
| Adjustments for | ||||
| Depreciation and amortization | 4,799 | 5,010 | ||
| Impairment losses | 598 | 721 | ||
| Income taxes in profit and loss Financial result, net |
$-149$ 4,249 |
$-118$ 5,129 |
||
| Net movement in defined benefit obligation | 106 | $-109$ | ||
| Share of net profit of associate and a joint | 101 | 195 | ||
| venture | ||||
| Share based payment expense Other |
409 $-78$ |
381 | ||
| -64 | ||||
| Changes in working capital Net movement in inventories |
$-3,388$ | $-4,428$ | ||
| Net movement in trade and other receivables | ||||
| and other current assets | 1,844 | 6.975 | ||
| Net movement in trade payables & other current liabilities |
$-2,367$ | $-3,159$ | ||
| Net movement in deferred income | 6.16 | 629 | 87 | |
| $-30,523$ | $-20,938$ | |||
| Interests paid | $-3,227$ | $-3,585$ | ||
| Taxes paid | $-2$ | -3 | ||
| Cash flow used in operating activities |
-33,752 | $-24,526$ | ||
| Investing activities | ||||
| Interest received | 5 | 7 | ||
| Acquisition of property, plant & equipment | $-952$ | $-1,020$ | ||
| Acquisition of intangible assets | 0 | $-15$ | ||
| Investment financial asset | $-1,140$ | 0 | ||
| Cash flow used in investing activities | $-2,087$ | $-1,028$ | ||
| Financing activities | ||||
| Repayment of borrowings | 6.15 | $-3,457$ | $-3,435$ | |
| Bank charges | -61 | $-21$ | ||
| Cash flow from financing activities | $-3,518$ | $-3,456$ | ||
| Net increase / (decrease) in cash and cash equivalents |
$-39,357$ | -29,010 | ||
| Cash and cash equivalents at the beginning of the period |
123,668 | 178,725 | ||
| Effects of exchange rate changes on the balance of cash held in foreign currencies |
594 | -41 | ||
| Cash and cash equivalents at the end of the period* |
84,905 | 149,674 |
| In EUR 000 | Notes | Share capital | Share premium |
Share based payment reserve |
Other comprehensive income |
Accumulated deficit |
Total equity attributable to the owners of the Group |
Total equity |
|---|---|---|---|---|---|---|---|---|
| Balance as at 1 January 2020 | $-220,668$ | 698,027 | 4,670 | $-5,291$ | -392,259 | 84,480 | 84,480 | |
| Loss for the period | $-31,558$ | $-31,558$ | $-31,558$ | |||||
| Re-measurement gains and losses on defined benefit plan Consolidation translation difference |
$-83$ | 86 | $-83$ 86 |
$-83$ 86 |
||||
| Total comprehensive income | $-83$ | $-31,472$ | $-31,555$ | $-31,555$ | ||||
| Share-based payment expense | 381 | 381 | 381 | |||||
| Other | $\Omega$ | $\circ$ | ||||||
| Balance as at 30 June 2020 | $-220,668$ | 698,027 | 5,051 | $-5,374$ | -423,731 | 53,305 | 53,305 | |
| Balance as at 1 January 2021 | $-220,657$ | 711,874 | 6,102 | $-5,152$ | -455,343 | 36,824 | 36,824 | |
| Loss for the period | $-37,276$ | $-37,276$ | $-37,276$ | |||||
| Re-measurement gains and losses on defined benefit plan Consolidation translation difference |
$-337$ | 152 | $-337$ 152 |
$-337$ 152 |
||||
| Total comprehensive income | $-337$ | $-37,461$ | ||||||
| Share-based payment expense Other |
410 | -37,124 | $-37,461$ 410 0 |
410 $\circ$ |
||||
| Balance as at 30 June 2021 | $-220,657$ | 711,874 | 6,512 | $-5,489$ | $-492,467$ | $-227$ | $-227$ |
Biocartis Group NV, a company incorporated in Belgium with registered address at Generaal de Wittelaan 11 B, 2800 Mechelen, Belgium (the 'Company') and its subsidiaries (together, the 'Group') commercialize an innovative and proprietary molecular diagnostics ('MDx') platform that offers accurate, highly-reliable molecular information from virtually any biological sample, enabling fast and effective diagnostics treatment selection and treatment progress monitoring
The Group's mission is to become a global, fully integrated provider of novel molecular diagnostics solutions with industry-leading, high clinical value tests within the field of oncology and infectious disease. The Group has established subsidiaries in Mechelen (Belgium), New Jersey (US), Milan (Italy) and a joint venture in Hong Kong (China).
The consolidated financial statements have been authorized for issue on 31 August 2021 by the board of directors of the Group (the 'board of directors').
The principal accounting policies for preparing these consolidated financial statements are explained below.
These condensed consolidated interim financial statements for the six months ended 30 June 2021 have been prepared in accordance with the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and as adopted by the European Union. The statements should be read in conjunction with the annual financial statements for the year ended 31 December 2020, which have been prepared in accordance with IFRS as adopted by the EU.
The accounting policies adapted in the preparation of the condensed interim financial statements are consistent with those applied in the preparation of the financial statements for the year ended 31 December 2020. New standards or interpretations applicable from 1 January 2021 do not have an impact on the condensed consolidated interim financial statements.
The consolidated financial statements are presented in Euro (EUR) and all values are rounded to the nearest thousand (EUR000), except when otherwise indicated.
These condensed interim financial statements have been subject to a review by the Group's external auditor Deloitte Bedrijfsrevisoren BV CVBA. The following new standards and amendments to standards are mandatory for the first time for the financial year beginning 1 January 2021:
The above application of new standards did not have a significant impact on the financial position and the result of the Group.
.
•
The interim results for the six months ended 30 June 2021 show a negative result, and the balance sheet includes a loss carried forward. The Board of Directors has examined the statements and accounting standards. Taking into account the cash position and the credit facilities that the Group has at its disposal, the Board of Directors is of the opinion that it can submit the interim financial statements on a going concern basis. Furthermore, and although no assurance can be given, the board is confident that the Group's strategic plans and the corresponding operating plans are viable so that the Group will have access to additional financial resources if and when required.
Assessing the indicators for revenue recognition under collaboration arrangements requires judgement to determine (i) the nature of the contractual performance obligations and whether they are distinct or should be combined with other performance obligations, and (ii) the pattern of transfer of each promised component identified in the contract, using methods based on key assumptions such as forecasted costs and development timelines of the collaboration arrangements for the assessment of satisfaction of the performance obligation.
For all performance obligations linked to licensing agreements, the Group makes an assessment about whether or not the license is to be considered as a distinct performance obligation or not. The Group determines whether a promise to grant a license of intellectual property is distinct from other promised goods or services in the contract. As such, the Group assesses whether the customer can benefit from a license of intellectual property on its own or together with readily available resources (i.e., whether it is capable of being distinct) and whether the Group's promise to transfer a license of intellectual property is separately identifiable from other promises in the contract (i.e., whether it is distinct in the context of the contract). The assessment of whether a license of intellectual property is distinct is based on the facts and circumstances of each contract, e.g. interdependencies between the license and other services in the contract, the continuing involvement of the Group after the license has been granted.
If the transfer of the license is considered to be a separate performance obligation, revenue relating to the transfer of the license is recognized at a point in time or over time depending on the nature of the license, i.e. granting a right to use the intellectual property or the right to access the IP. Basically, the Group assesses whether the customer has the right to use the intellectual property as it exists at a certain period in time or whether it has access to the intellectual property as it exists at any time during the license period, where the latter requires more on-going activities from the Group.
The Group's revenue can be aggregated as follows:
| For the 6 months ended, | |||||
|---|---|---|---|---|---|
| In EUR 000 | 30 June 2021 | ||||
| At a point in time |
Over time | 30 June 2021 |
30 June 2020 |
||
| Collaboration revenue | |||||
| R&D services | $\Omega$ | 2,590 | 2.590 | 4,623 | |
| License fees | 50 | 50 | 123 | ||
| Milestones | $\left( \right)$ | ||||
| ο | 2,640 | 2,640 | 4,746 | ||
| Product related | |||||
| revenue | |||||
| Idylla™ system sales revenue | 1.878 | Ω | 1.878 | 844 | |
| Idylla™ system rental revenue | 1.837 | ∩ | 1.837 | 993 | |
| Cartridge revenue | 14.749 | 14.749 | 9.584 | ||
| 18,463 | о | 18,463 | 11.421 |
Service revenue
| Total | 19,118 | 2,733 | 21,851 | 16,696 |
|---|---|---|---|---|
| 654 | 94 | 748 | 530 | |
| revenue | 654 | 9Δ | 748 | 53C |
| ldylla''' system service |
For details related to the movement in deferred income of collaboration agreements, we refer to note 6.19.
R&D service revenue is recognized over time as the services are rendered to the customer based on the progress over the activities i.e. a rato the services performed. Over the reporting period, the majority of the collaborations for which revenues were recognized, included a quarterly or monthly payment structure. Consequently, the Group recognized either an accrued income or deferred income on the balance sheet over the course of the reporting period.
In general, customers do not have a right-of return and/or are not entitled to refunds in the context of product related sales.
The below table corresponds to the revenue expected to be recognized in the future relating to (partially) unsatisfied performance obligations. This table excludes potential future R&D service revenue of pending collaborations for which the associated services are performed on an hourly invoicing basis (IFRS 15.121).
| In EUR 000 | Deferred income |
|
|---|---|---|
| 2021 | 709 | |
| 2022 | 175 | |
| 2023 | ||
| 2024 | ||
| 2025 | ||
| After 2025 | ||
For more information regarding the revenue statement above, we refer to chapter 3, 'Commercial highlights'.
| For the 6 months ended | ||||
|---|---|---|---|---|
| In EUR 000 | 30 June 2021 | 30 June 2020 | ||
| Country of domicile | 261 | 256 | ||
| Belgium | 261 | 256 | ||
| Total all foreign countries, of which | 21,590 | 16,441 | ||
| United states of America | 4.134 | 6,851 | ||
| Great Britain | 4.341 | 699 | ||
| China | 765 | 372 | ||
| Spain | 1.655 | 1,322 | ||
| France | 2.298 | 1.396 | ||
| Germany | 1.515 | 1,322 | ||
| Rest of the world | 6.883 | 4.479 | ||
| Total | 21,851 | 16,697 |
Revenues in the above table are assigned according to the location of the Group or parent company of the customer. The Group has recognized revenues from one customer representing 13% of the total revenues and three other major customers together represent 11% of the total revenues.
| For the 6 months ended | |||
|---|---|---|---|
| In EUR 000 | 30 June 2021 | 30 June 2020 | |
| R&D project support (VLAIO & IWT grants) | 1.159 | 312 | |
| Other project grants (EU) | 56 | ||
| Other income | 48 | 541 | |
| Total | 1,206 | 909 |
The other operating income mainly consists out of grants that were awarded to support R&D activities. In 2021, the Group was awarded a new grant from VLAIO, for the ongoing development of a new generation Idylla™ technology.
The cost of goods sold in relation to the product sales is as follows:
| For the 6 months ended | ||
|---|---|---|
| In EUR 000 | 30 June 2021 | 30 June 2020 |
| Employee benefit expenses | -4.543 | $-2,332$ |
| Material, lab consumables & small equipment | $-8.301$ | $-4.233$ |
| Depreciation and amortization | $-2.339$ | $-1.384$ |
| Royalty expense | $-774$ | $-687$ |
| Facilities, office and other | $-1,103$ | $-597$ |
| Total | -17.059 | -9,233 |
The volume of commercial cartridges sold in H1 2021 increased with 96% compared H1 2020, which resulted in higher cost of goods sold, mainly the variable costs increased accordingly such as employee benefit expenses, material, lab consumables & small equipment. Depreciation and amortization increased due to the new Idylla™ instrument placements that were added to the installed based in H1 2021.
| For the 6 months ended | ||
|---|---|---|
| In EUR 000 | 30 June 2021 | 30 June 2020 |
| Employee benefit expenses | $-12.967$ | $-11.889$ |
| Laboratory costs | $-7.155$ | $-3,383$ |
| Quality, regulatory and intellectual property | $-269$ | $-285$ |
| Facilities, office & other | $-997$ | $-1.588$ |
| ICT | $-177$ | $-142$ |
| Travel, training & conferences | $-41$ | $-121$ |
| Depreciation and amortization | $-1,793$ | $-2,896$ |
| Total | -23.398 | -20.303 |
Laboratory costs include consumables and prototype costs related to the development of diagnostic platform prototypes and assays, expenses in relation to services provided by research and development providers such as services related to the development of assay cartridges, instrument and console of the various diagnostic platforms, manufacturing equipment design and engineering services. The increase in laboratory costs is mainly related to the planned acceleration and diversification of the Idylla™ test menu, both in oncology and in infectious diseases.
The remaining expenses relate to quality, regulatory, patenting, building facilities, ICT, office, maintenance of equipment, logistics, travel, training and conferences.
| For the 6 months ended | ||
|---|---|---|
| In EUR 000 | 30 June 2021 |
30 June 2020 |
| Employee benefit expenses | -5.547 | $-5,017$ |
| External advice | $-314$ | $-321$ |
| Facilities, office & other | $-1.087$ | $-230$ |
| Human resources | $-675$ | $-504$ |
| Travel, training & conferences | $-25$ | $-138$ |
| Depreciation and amortization expenses | $-286$ | $-281$ |
| Total | -7,935 | -6.491 |
External advice expenses include fees, service and consulting expenses related to legal, human resources, investor relations, accounting, audit and tax services. Facilities, office & other include office, insurance and other miscellaneous expenses used in general and administrative activities. Facilities, office & other increased due to the growing business and the planned acceleration and diversification of the Idylla™ test menu, which resulted in higher ICT, consultancy and insurance costs.
| For the 6 months ended | ||
|---|---|---|
| In EUR 000 | 30 June 2021 | 30 June 2020 |
| Interest expense | -4.642 | $-5,050$ |
| Other financial expense | -61 | $-33$ |
| Total | -4,703 | $-5,083$ |
| Other financial result | 454 | $-46$ |
| Total | 454 | $-46$ |
| Financial result, net | $-4,249$ | $-5,129$ |
Net financial result amounted to EUR 4.2m per 30 June 2021 compared to EUR 5.1m as per 30 June 2020 and include financial expenses in relation to the Company's convertible bond of EUR 4.1m in H1 2021 compared to EUR 4.5m in H1 2020. The other financial result mainly consists of non-realized foreign exchange gains and losses.
The Group has stock option plans that may be settled in common shares of the Group, and which are considered anti-dilutive given that the Group's operations were loss making over the reporting period. As such, the basic and diluted earnings per share are equal. The basis for the basic and diluted earnings per share is the net loss for the year attributable to the owners of the Group.
| For the 6 months ended | ||
|---|---|---|
| 30 June 2021 | 30 June 2020 | |
| Profit/loss for the period attributable to the owners of the Group (in EUR 000) |
-37.276 | -31.558 |
| Weighted average number of ordinary shares for basic loss per share (in number of shares) |
57.545.663 | 56.695.322 |
| Basic loss per share (EUR) | -0.65 | -0.56 |
| As of | ||
|---|---|---|
| In EUR 000 | 30 June 2021 | 31 Dec 2020 |
| Property, plant and equipment | 38.381 | 40.098 |
| Total property, plant and equipment | 38,381 | 40,098 |
Property, plant and equipment decreased to EUR 38.4m as per end of June 2021 from EUR 40.1m at the end of 2020 (decrease of EUR 1.7m) mainly driven by a depreciation charge of EUR 4.5m and capital expenditures in H1 2021 of EUR 3.4m. The capital expenditures are predominantly related to capitalized Idylla™ systems sold under reagent rental and similar agreements and right-of-use assets.
| As of | ||
|---|---|---|
| In FUR 000 | 30 June 2021 | 31 Dec 2020 |
| Financial asset | 1.140 | |
| Total financial asset | 1,140 |
The Group holds a convertible note from GeneproDx, with maturity date of 25 January 2023 (i.e. 2-year duration) and a coupon of 10%. The convertible note from GeneproDx was issued early 2021 and was issued to the Group as payment for the license granted by the Group to GeneproDx at the end of 2020, which was recorded in 2020 as a receivable under 'other current assets'.
| As of | ||
|---|---|---|
| In EUR 000 | 30 June 2021 | 31 Dec 2020 |
| VAT receivables | 3.074 | 2.133 |
| Tax credit research and development | 330 | 310 |
| Other receivables | 1.460 | 1.518 |
| Total | 4,865 | 3,960 |
Other receivables include VAT receivables and amongst others amounts recorded for the government capital grant by STS Strategic Transformation Support) related to the investments in the second cartridge manufacturing facilities in Mechelen.
The financial debt can be analyzed as follows:
| As of | ||
|---|---|---|
| In EUR 000 | 30 June 2021 | 31 Dec 2020 |
| Lease liabilities Bank borrowings |
16.221 $\left( \right)$ |
18,625 $\left( \right)$ |
| Convertible bond | 126,675 | 125,260 |
| Total non-current | 142,896 | 143,885 |
| Lease liabilities Bank borrowings |
6.516 O |
6.615 58 |
| Total current | 6,516 | 6,673 |
| Total financial liabilities | 149,412 | 150,557 |
In 2013, Biocartis NV refinanced about 50% of its Idylla™ semi-automated cartridge manufacturing line in Mechelen (Belgium) via a sale and lease back operation. This lease has a current lease term till 1 June 2021, carries a 3.35% interest rate and includes a purchase option of EUR 0.1m. As per the end of H1 2021 the lease has been fully paid.
In 2015, Biocartis NV obtained two new financing facilities for the modifications to the current cartridge production line. The first new facility entails an investment credit for an amount of EUR 0.6m, with a payment term of 5 years and an interest rate of 1.93%. The second one entails a leasing facility for EUR 4.4m that carries a 1.77% interest, includes a purchase option of 1% of the financed amount and has a duration of 54 months. As per the end of H1 2021 EUR 0.5m is outstanding under these two facilities.
In 2016, Biocartis NV obtained a lease financing facility for the development of a second cartridge production line in Mechelen, for EUR 15m. This facility was increase in 2018 with EUR 2.3m. The interest applicable for this facility equals 1.87% and includes a purchase option of 1% of the financed amount. As per the end of H1 2021 EUR 7.4m is outstanding under this facility. As a security, a debt service reserve account is to be maintained for all of the above financing facilities, the current debt service account amounts to EUR 1.2m.
In 2018, Biocartis NV obtained an investment credit of EUR 1m from a bank to finance mold investments related to its first cartridge manufacturing facility. The investment credit has a payment term of 5 years and an interest rate of 2.53%. In total EUR 0.8m has been withdrawn on this credit facility. As per 30 June 2021, EUR 0.5m is outstanding under this credit facility.
On 9 May 2019, the Group issued a convertible bond of EUR 150m, with a maturity date of 9 May 2024 (i.e. 5-year duration) and a coupon of 4%. The bond can be converted into new/existing ordinary shares of the Group upon the discretion of the bondholder. Under IAS 32- Financial instruments: Presentation the convertible bond is a compound financial instrument and contains, from the issue's perspective, both a liability (i.e. host debt instrument) and an equity component (i.e. an embedded share conversion option). The liability amounts to EUR 126.7m per 30 June 2021.
The credit facility and guarantees from BNP Paribas Fortis have been canceled in 2021 and replaced by a revised credit facility of KBC. This facility consists of a EUR 7.5m straight loan and a EUR 7.5m rollover credit line. No amounts have been withdrawn on this credit facility as per 30 June 2021.
| As at | ||
|---|---|---|
| In EUR 000 | 30 June 2021 | 31 Dec 2020 |
| Grants | 545 | 658 |
| Collaboration income | 1.725 | 983 |
| Total | 2,270 | 1,641 |
| Current | 1.932 | 1.278 |
| Non-current | 338 | 363 |
| Deferred partner income |
|
|---|---|
| As per 31 December 2019 | 1,197 |
| Invoiced | 3.369 |
| Recognized in profit or loss | $-3,583$ |
| As per 31 December 2020 | 983 |
| Invoiced | 1.073 |
| Recognized in profit or loss | $-330$ |
| As per 30 June 2021 | 1.726 |
Deferred partner income includes upfront payments from collaboration partners in relation to the strategic licensing, development and commercialization collaborations.
The fair value of the financial assets has been determined on the basis of the following methods and assumptions:
The fair value of the financial liabilities has been determined on the basis of the following methods and assumptions:
The Group uses the following hierarchy for determining and disclosing the fair value of financial instruments by valuation technique:
The Group has one financial instrument (MyCartis) carried at fair value through OCI in the consolidated balance sheet on 30 June 2021 and 31 December 2020.
Except for the borrowings (financial liabilities, see note 6.18), the carrying amount of the financial assets and liabilities approximate their fair values. The borrowings with a carrying amount of EUR 149.4m (31 December 2020: EUR 150.6m) have a fair value of EUR 149,5m (31 December 2020: EUR 150.6m).
The Group has no new contingencies compared to 31 December 2020.
6.17.3.1. Capital commitments
As per 30 June 2021, the Group has EUR 1.7m capital commitments mainly related to the upgrade of its cartridge production lines located in Mechelen (Belgium) for which the Group is engaged in several contractual arrangements with specified suppliers. The Group had no other material capital commitments on 30 June 2021.
6.17.3.2. Operating commitments
As per 30 June 2021, the Group has operating commitments towards different suppliers for Idylla™ systems and cartridge parts for a total amount of EUR 8.4m. It is expected that the majority of the commitments will be fulfilled in 2021.
Transactions between the Group and its subsidiaries have been eliminated on consolidation and are not disclosed in the notes. Apart from the remuneration of key management and the transactions with the joint venture, there were no other transactions with related parties.
The following events took place after 30 June 2021:
Product registrations Taiwan Additional registrations for Idylla™ products have been completed in Taiwan;
Launch Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD) Successful CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel which detects SARS-CoV-2, Flu A/B and RSV nucleic acids in one single cartridge within approx. 90 minutes. Timing of the Emergency Use Authorization ('EUA') submission to the US FDA for the Idylla™ SARS-CoV-2/Flu/RSV Panel is to be decided.
Report on the review of the consolidated interim financial information of Biocartis Group NV for the six-month period ended 30 June 2021
In the context of our appointment as the company's statutory auditor, we report to you on the consolidated interim financial information. This consolidated interim financial information comprises the condensed consolidated statement of financial position as at 30 June 2021, the condensed consolidated income statement. the condensed consolidated statement of other comprehensive income, the condensed consolidated statement of changes in equity and the condensed consolidated cash flow statement for the period of six months then ended, as well as selective notes.
We have reviewed the consolidated interim financial information of Biocartis Group NV ("the company") and its subsidiaries (jointly "the group"), prepared in accordance with International Accounting Standard (IAS) 34, "Interim Financial Reporting" as adopted by the European Union.
The condensed consolidated statement of financial position shows total assets of 170 612 (000) EUR and the condensed consolidated income statement shows a consolidated loss (group share) for the period then ended of 37 276 (000) EUR.
The board of directors of the company is responsible for the preparation and fair presentation of the consolidated interim financial information in accordance with IAS 34, "Interim Financial Reporting" as adopted by the European
14 Previously referred to as the Idyllam 'FLEX' technology, aimed to tap into new market opportunities with customized and personalized products
Union. Our responsibility is to express a conclusion on this consolidated interim financial information based on our review.
We conducted our review of the consolidated interim financial information in accordance with International Standard on Review Engagements (ISRE) 2410, "Review of interim financial information performed by the independent auditor of the entity". A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit performed in accordance with the International Standards on Auditing (ISA) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion on the consolidated interim financial information.
Based on our review, nothing has come to our attention that causes us to believe that the consolidated interim financial information of Biocartis Group NV has not been prepared, in all material respects, in accordance with IAS 34, "Interim Financial Reporting" as adopted by the European Union.
Signed at Zaventem, 1 September 2021
The statutory auditor, Deloitte Bedrijfsrevisoren/Réviseurs d'Entreprises CVBA/SCRL, Represented by Nico Houthaeve
Biocartis Group NV is a limited liability company organized under the laws of Belgium and has its registered office at Generaal de Wittelaan 11 B, 2800 Mechelen, Belgium. Throughout this report, the term 'Biocartis NV' refers to the non-consolidated Belgian subsidiary company and references to 'the Group' or 'Biocartis' include Biocartis Group NV together with its subsidiaries.
Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. This report is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This report does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.
As defined by Belgian law, Biocartis has to publish its financial report in the English and Dutch language. In case of difference in interpretation, the English version prevails. An electronic version of the half-year financial report 2021 is available on the Biocartis website. Other information on the Biocartis website or on other websites is not a part of this half-year report.
Biocartis Investor Relations Renate Degrave, Head of Corporate Communications and Investor Relations Generaal de Wittelaan 11 B 2800 Mechelen, Belgium +32 15 632 600 [email protected]
Biocartis is listed on Euronext Brussels since 27 April 2015 under the symbol BCART. Biocartis' ISIN code is BE0974281132.
10 November 2021 24 February 2022 31 March 2022
Q3 2021 Business Update 2021 full year results Publication 2021 annual report
The financial year starts on 1 January and ends on 31 December.
Deloitte Bedrijfsrevisoren B.V. o.v.v.e. CVBA, represented by: Nico Houthaeve Gateway Building Luchthaven Nationaal 1J 1930 Zaventem Belgium
Certain statements, beliefs and opinions in this report are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forwardlooking statements contained in this report regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this report, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this report as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this report or the actual occurrence of the forecasted developments. You should not place undue reliance on forwardlooking statements, which speak only as of the date of this report.
| Assay | In the field of diagnostics, an assay is a process or method aimed at determining the presence or amount (quantitative assay) of a certain substance in a sample. |
|---|---|
| Application | In the context of the Idylla™ platform, an application is a specific Nucleic Acid detection assay (test) that is to run on the system. Applications have their own specific requirements. |
| Batch Record | The set of records of all relevant process information in any physical or electronic format. |
| Biopsy (solid/liquid) | The Idylla™ platform is capable of processing both solid biopsies (FFPE tissue which is the standard tissue type for solid tumor diagnostics, and fresh (frozen) tissue samples) and liquid biopsies. These are easier to obtain sample types such as blood plasma or urine. Liquid biopsy based assays will facilitate monitoring of treatments and disease progression, and possible earlier disease detection. |
| Serine/threonine-protein kinase B-raf (BRAF) |
BRAF is a protein that, in humans, is encoded by the BRAF gene. The BRAF protein is involved in sending signals within cells and in cell growth. Certain inherited BRAF mutations cause birth defects. Alternatively, other acquired mutations in adults may cause cancer. |
| CE-mark | The CE-mark is a mandatory conformance mark on many products placed on the market in the European Union. With the CE-marking on a product, the manufacturer ensures that the product is in conformity with the essential requirements of the applicable European Union directives. The letters "CE" stand for 'Conformité Européenne' ('European Conformity'). |
| Clinical data | ety and/or performance information that are generated from the clinical use of a medical device. |
| Companion Diagnostics (CDx) |
CDx is a bio-analytical method designed to assess: (i) whether or not a patient will respond favorably to a specific medical treatment; (ii) what the optimal dose is for a patient; and (iii) whether the patient can expect certain side effects from a medical treatment. Any prescription of a drug with a CDx is based on the outcome of the CDx. CDx tests are also used in the drug development process. |
| COVID-19 | COVID-19 or the novel coronavirus is caused by SARS-CoV-2. Coronaviruses are named for the crown-like spikes on their surface (source: www.cdc.org). |
| CLIA | The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease (source: https://wwwn.cdc.gov/clia/). |
| Consumables | Materials that are in direct or indirect contact with final product. |
| ctDNA | This is circulating tumor DNA. |
| Deoxyribonucleic acid (DNA) |
DNA is a nucleic acid molecule that contains the genetic instructions used in the development and functioning of living organisms. |
| Distributor | Person or legal entity that furthers the marketing and/or selling of a device from the original place of manufacture to the ultimate user without modifying the device, its packaging or its labelling. |
| Epidermal growth factor receptor (EGFR) |
EGFR is a protein found on the surface of certain cells which can cause them to divide. It is found in abnormally high levels on the surface of many types of cancer cells. |
| Emergency Use Authorization (EUA) |
This is an authorization given by the FDA Commissioner pursuant to section 564 of the US Federal Food, Drug, and Cosmetic Act, as amended (the 'FD&C Act'), which allows unapproved medical products or unapproved uses of approved medical products to be used in the United States in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear threat agents when there are no adequate, |
| approved, and available alternatives. | |
|---|---|
| Formalin fixed, paraffin embedded (FFPE) |
FFPE tissues are samples, typically from suspected tumors, that are fixed or mixed with formalin to preserve the structural integrity of the sample. The sample is then embedded into a type of paraffin wax so that it can be sliced into very fine slices, 5-10 microns thick. Treating samples in this manner enables the samples to be stained with dyes to analyze abnormalities in tissue that is suspected of cancer. |
| Gene fusions | Studies over the past decades have uncovered fusion genes, a class of oncogenes that provide immense diagnostic and therapeutic advantages because of their tumor-specific expression. Originally associated with hemotologic cancers, fusion genes have recently been discovered in a wide array of solid tumors, including sarcomas, carcinomas, and tumors of the central nervous system. Fusion genes are attractive as both therapeutic targets and diagnostic tools due to their inherent expression in tumor tissue alone. Therefore, the discovery and elucidation of fusion genes in various cancer types may provide more effective therapies in the future for cancer patients (source: Parker BC, Zhang W. Fusion genes in solid tumors: an emerging target for cancer diagnosis and treatment. Chin J Cancer. 2013;32(11):594-603. doi:10.5732/cjc.013.10178) |
| (US) Food and Administration (FDA) |
Drug The FDA is a federal agency of the United States Department of Health and Human Services responsible for protecting and promoting public health through the regulation and supervision of, among other things, medical devices. |
| ICU | Intensive Care Unit |
| Idylla Platform | Combination of the Idylla™ Instrument (hardware and software) and the Idylla™ Console (hardware and software) using the Idylla™ cartridge technology. |
| Idylla ™ Cartridge | Refers to the disposable container containing the necessary reagents to perform a Test with the System. |
| Immunoassay | Immunoassays are assays that measure biomarkers through antigen-antibody interaction technologies. In most cases such assays are used to measure biomarkers of the immune system itself, e.g. HCV or HIV antibodies produced by the bodies, which are detected by means of HCV or HIV antigens. |
| Influenza | Also known as 'the flu' is a highly contagious respiratory tract infection caused by the family of influenza viruses. |
| In vitro diagnostics or In vitro diagnosis (IVD) |
IVD is a diagnostic test outside of a living body in contrast to "in vivo", in which tests are conducted in a living body (for example an X-ray or CT-scan). |
| (IUO) | Investigational Use Only Investigational Use Only (IUO) product is an IVD product, in the testing phase of product development that is being shipped or delivered for product testing prior to full commercial marketing. |
| oncogene (KRAS) | Kirsten rat sarcoma-2 virus KRAS is a protein that, in humans, is encoded by the KRAS gene. Like other members of the Ras family, the KRAS protein is a GTPase (a large family of hydrolase enzymes that can bind and hydrolyse guanosine triphosphate), and is an early player in many signal transduction pathways. The protein product of the normal KRAS gene performs an essential function in normal tissue signalling, and the mutation of a KRAS gene is associated with the development of many cancers. |
| KOL | Key Opinion Leader. |
| Manufacturer | Natural or legal person responsible for the design, manufacture, fabrication, assembly, packaging or labelling of a medical device, for assembling a system, or adapting a medical device before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or on their behalf by a third party. |
| Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, |
| Medical Device | software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury, - investigation, replacement, modification, or support of the anatomy or of a physiological process, - supporting or sustaining life, - control of conception, - disinfection of medical devices, - providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. |
|---|---|
| Metastatic Colorectal Cancer (mCRC) |
Colorectal Cancer (CRC) is the second most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually. According to the International Agency for Research on Cancer, an estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer. |
| Molecular diagnostics (MDx) |
MDx is a form of diagnostic testing used to detect specific sequences in DNA or RNA that may or may not be associated with disease. Clinical applications of MDx include infectious disease testing, oncology, pharmacogenomics and genetic disease screening. |
| Micro satellite instability (MSI) |
MSI is a genetic hyper-mutability condition resulting from MMR that is functioning abnormally. |
| Multiplexing | The simultaneous detection of more than one analyte or biomarker from a single sample. |
| Neuroblastoma RAS viral (v-ras) oncogene (NRAS) |
NRAS is a protein that is encoded, in humans, by the NRAS gene. Like other members of the Ras family, the NRAS protein is a GTPase (a large family of hydrolase enzymes that can bind and hydrolyse guanosine triphosphate), and is an early player in many signal transduction pathways. The protein product of the normal NRAS gene performs an essential function in normal tissue signaling, and the mutation of a NRAS gene is associated with the development of many cancers |
| Next-Generation Sequencing (NGS) |
Sequencing is the process of determining the precise order of nucleotides within a DNA molecule. It includes any method or technology that is used to determine the order of the four bases- adenine, guanine, cytosine, and thymine-in a strand of DNA. The high demand for low-cost sequencing has driven the development of high-throughput sequencing technologies that parallelize the sequencing process, producing thousands or millions of sequences concurrently. High-throughput sequencing technologies are intended to lower the cost of DNA sequencing beyond what is possible with standard dye-terminator methods. |
| Performance study | Performance study means a study undertaken to establish or confirm the analytical or clinical performance of a device. |
| (PCR) | Polymerase chain reaction The specific and exponential amplification of DNA sequences by consecutive thermal cycling steps. Real-time PCR is a form of PCR whereby the amplified sequences are made visible by means of fluorescent labelling in real time, i.e., as they become synthesized. Real-time PCR can be used to estimate the quantity of target DNA sequences in a multiplexed way. PCR and real-time PCR can also be used to detect and quantify RNA sequences after a DNA copy has been made from the RNA sequence by means of a reverse transcriptase enzyme. |
| Protein | Polypeptide chain built from the 20 natural amino acids. Proteins are synthesized from a messenger RNA copy of a gene and can have many functions in the cytoskeleton of the cell, enzymatic, messenger functions in cells and blood such as immune cytokines, DNA binding proteins that regulate expression, etc. |
| Prototype | (First) materialization of the intended product |
| Regulatory authority | A government agency or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and can take legal action to ensure that medical devices |
| Respiratory Syncytial Virus (RSV) |
RSV is a major cause of lower respiratory tract infection that is a frequent infection in children. |
|---|---|
| Research Use Only (RUO) | This is a category of non-approved (i.e. no CE-marking and FDA approval) medical device products that can solely be used for research purposes. Many producers introduce their products first as RUO and/or IUO products, prior to obtaining 510(k) clearance or PMA approval. |
| Ribonucleic acid (RNA) | RNA, like DNA, is a nucleic acid molecule. RNAs have a variety of different functions in living cells. They can have a scaffolding role in the build-up of complexes (ribosomes, SNRPs), provide sequence recognition (translation, RNA spicing), have catalytic function (ribozymes), act as messengers for protein synthesis (mRNAs), regulate gene expression (miRNAs) or make up the genome of certain viruses. |
| SARS-CoV-2 | The novel coronavirus that causes coronavirus disease 2019, or COVID-19). Coronaviruses are named for the crown-like spikes on their surface (source: www.cdc.org). |
| Screening Test | An initial or preliminary test. Screening tests do not tell you if you definitely have a disease or condition. Rather, positive results indicate that you may need additional tests or a doctor's evaluation to see if you have a particular disease or condition. |
| Sepsis | Sepsis is a potentially life-threatening condition caused by the body's response to an infection. The body normally releases chemicals into the bloodstream to fight an infection. Sepsis occurs when the body's response to these chemicals is out of balance, triggering changes that can damage multiple organ systems (source: www.mayoclinic.org). |
| Serine/threonine-protein kinase B-raf (BRAF) |
BRAF is a protein that, in humans, is encoded by the BRAF gene. The BRAF protein is involved in sending signals within cells and in cell growth. Certain inherited BRAF mutations cause birth defects. Alternatively, other acquired mutationns in adults may cause cancer. |
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.