Earnings Release • Mar 1, 2018
Earnings Release
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Mechelen, Belgium, 1 March 2018 – Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces its operational highlights and financial results for 2017, prepared in accordance with IFRS as adopted by the European Union as well as selected post period events and its outlook for 2018.
Biocartis will host a conference call with live webcast presentation today at 14:00 CET / 13:00 BST (UK) / 08:00 EDT (US) to discuss the 2017 results. Click here to access the live webcast.
To participate in the questions and answers session, please dial 5-10 minutes prior to the start time the number +44(0)330 336 9105 (standard international), followed by the confirmation code 8419378.
A replay of the webcast will be available on the Biocartis investors' website shortly after.
1 RoW = Rest of the World. RoW is defined as the world excluding European direct markets, US, China and Japan.
Biocartis and its distribution partner Fisher Healthcare2 initiated the US commercialization of the Idylla™ platform in Q3 2017, and successfully installed the first Idylla™ instruments with US customers.
2 Fisher HealthCare is part of Thermo Fisher Scientific Inc.
3 Biocartis and Amgen announced a first collaboration on 3 February 2016, aimed at accelerating access to RAS biomarker information for metastatic colorectal cancer (mCRC) patients in a number of selected countries worldwide (Brazil, Canada, Colombia, Mexico, Saudi Arabia, Spain and Turkey) and expanded their collaboration on 22 December 2016 to additional selected hospitals in up to 10 European countries.
4 One in eight women is diagnosed with breast cancer in her lifetime. Source: World Health Organization, www.breastcancer.org, last consulted on November 2017.
5 LifeArc is an independent UK based life science medical research charity and aims to move promising medical research forward into patient treatments and diagnostics and has been involved in helping deliver a number of therapies including Keytruda® (pembrolizumab, marketed by MSD) which is an important immunotherapy treatment for various cancers.
6 Partnership is signed with ETPL, the commercialization arm of A*STAR, Singapore's Agency for Science, Technology and Research.
7 Microsatellite instability is the result of errors in the body's so-called DNA mismatch repair (MMR) system. Consequently, errors that normally spontaneously occur during DNA replication are no longer corrected, resulting potentially in tumor growth.
8 Merck KGaA, Darmstadt, Germany.
9 The collaboration does not include the US, China and Japan.
10 Recent data have shown that advanced CRC patients with an MSI-high status respond particularly well to certain immunotherapies (Xiao Y et al. (2015) The microsatellite instable subset of colorectal cancer is a particularly good candidate for checkpoint blockade immunotherapy. Cancer Discov. 5, 16-18; and, Le et al. (2015) PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med 372, 2509-2520).
11 Based on a comparison between the Biocartis' Idylla™ platform for the detection of EGFR mutations in archived formalin-fixed paraffin-embedded (FFPE) tumor samples with the results obtained by the TherascreenEGFR Pyro assay (Qiagen)-ISO 15189 accredited laboratory method.
12 Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).
Commenting on the 2017 results, Herman Verrelst, Chief Executive Officer of Biocartis, said: "2017 was a year of transition for Biocartis, building further momentum in its commercialization efforts with the aim to support the global adoption of the Idylla™ platform. Most important in that respect was the announcement in March to focus our own resources on oncology, driven by a strong traction in that market, and to seek accelerated Idylla™ test menu expansion through partnerships with pharma companies, co-development partners and third-party diagnostic test providers. The collaborations that we signed in 2017 as part of this strategy generated substantial income on top of a strong product revenue growth. Another key event was the successful launch of the Idylla™ platform in the US. Gaining commercial traction in that market will be an important revenue driver for our company going forward and will make Biocartis an even more attractive partner for pharmaceutical companies and diagnostic test content providers. As we continue to enjoy extremely positive feedback from our customers and partners on the quality and performance of the Idylla™ platform, I look forward to working with the team on executing our plans for 2018, which is poised to be another thrilling year for Biocartis!"
13 Of which EUR 3m for guarantees.
14 Systematic inflammatory response syndrome.
EIB financing facility – On 1 March 2018, Biocartis announced to have obtained a EUR 24m debt financing facility from the European Investment Bank. The financing facility is supported by InnovFin – EU Finance for Innovators' Infectious Diseases Finance Facility, with the financial backing of the European Union under its research and innovation programme Horizon 2020. It can be used to part-finance up to 50% of further investments in infectious diseases diagnostics solutions.
In order to efficiently execute the announced partnerships as well as new partnerships that the Company expects to add in the near future, Biocartis re-organized its assay development organization, decided to expand its assay development capabilities (including amongst others the establishment of an US R&D center) and re-prioritized resources across the portfolio of development projects. This has resulted in a shift of launch dates of some internal assay development projects in order to accommodate external commitments.
Based on Key Opinion Leaders (KOLs) feedback and extended market analysis, Biocartis evaluated the commercial potential of the Company's Next-Generation Sequencing (NGS) FFPE15 sample preparation and target enrichment capabilities on Idylla™ (the 'Idylla™ NGS Prep Panels') to complement its menu of Idylla™ qPCR 16 tests. Priority was given to develop a cancer hotspot NGS Prep Panel to complete the Idylla™ lung cancer menu, as the clinical utility of multi-gene panels for this cancer type are now gradually becoming accepted in the international clinical guidelines. Non-small-cell lung cancer is a highly prevalent and deadly cancer type, which is of high interest for pharmaceutical companies who are developing various types of therapies for this cancer type, many of which will require a CDx test. Easy-to-use and cost-efficient Idylla™ NGS Prep Panels will facilitate getting more of these therapies to the patient, which will expand the attractiveness of the Idylla™ platform for end-users in the lab, as well as create opportunities for additional collaborations with pharmaceutical companies. An updated Idylla™ test menu roadmap is included in the Company's corporate presentation that can be found here.
The tables below show an overview of the key figures and a breakdown of operating income for 2017. A consolidated income statement, balance sheet, cash flow statement and statement of changes in equity of Biocartis Group NV is presented in the paragraph 'Financial information' at the end of this press release.
15 Formalin fixed, paraffin embedded.
16 Quantitative Polymerase Chain Reaction or real-time PCR.
17 RUO = Research Use Only.
| 2017 | 2016 | % Change |
|---|---|---|
| 23,110 | 13,772 | 68% |
| -8,673 | -5,701 | 52% |
| -39,594 | -42,091 | -6% |
| -11,600 | -10,324 | 12% |
| -6,832 | -5,827 | 17% |
| -66,699 | -63,943 | 4% |
| -43,589 | -50,171 | -13% |
| -1,736 | -586 | 196% |
| 3,365 | 980 | 243% |
| -41,960 | -49,777 | -16% |
| -41,405 | -53,312 | -22% |
| -4,320 | -9,342 | -54% |
| 75,256 | 41,804 | 80% |
| 29,531 | -20,850 | -242% |
| 112,765 | 83,247 | 35% |
| 35,388 | 31,407 | 13% |
Including EUR 1.2m of restricted cash (as a guarantee for KBC Lease financing)
| Operating income (EUR 1,000) | 2017 | 2016 | % Change |
|---|---|---|---|
| Collaboration revenue | 7,739 | 5,278 | 47% |
| Idylla™ System sales | 4,620 | 2,752 | 68% |
| Idylla™ Cartridge sales | 8,316 | 4,015 | 107% |
| Product sales revenue | 12,936 | 6,767 | 91% |
| Service revenue | 282 | 53 | 432% |
| Total revenue | 20,957 | 12,098 | 73% |
| Grants and other income | 2,153 | 1,674 | 29% |
| Total operating income | 23,110 | 13,772 | 68% |
| Product sales revenue by type (EUR 1,000) | 2017 | 2016 | % Change |
|---|---|---|---|
| Commercial revenue | 12,748 | 5,691 | 124% |
| Research & Development revenue | 187 | 1,076 | -83% |
| Total product sales revenue | 12,936 | 6,767 | 91% |
Collaboration revenue increased year-over-year with 47% to EUR 7.7m in 2017 driven by a higher amount of received milestone payments (total amount of EUR 2.5m in 2017) and increased proceeds from R&D services (EUR 0.3m in 2017) combined with upfront license revenues that remained more or less at the same level of 2016 (EUR 4.6m in 2017). Product sales revenue equaled EUR 12.9m in 2017 versus EUR 6.8m in 2016 as a consequence of both higher cartridge and system sales.
Recognized grants and other income amounted to EUR 2.2m in 2017 which represents a year-over-year increase of 29% mainly because of recognition of higher R&D project support grants and training subsidies related to the establishment of a second cartridge manufacturing line. Furthermore, in March 2017 Biocartis received a EUR 750k grant from VLAIO18 to support Biocartis' ongoing microsatellite instability (MSI) and mutational load research program in collaboration with Prof. Diether Lambrechts (VIB – KU Leuven Center for Cancer Biology, Belgium).
Driven by the above Biocartis' total operating income in 2017 amounted to EUR 23.1m versus EUR 13.8m in 2016, representing an increase of 68%.
Total operating expenses in 2017 amounted to EUR 66.7m versus EUR 63.9m in 2016, an increase of 4%. This included cost of sales of EUR 8.7m in 2017 compared to EUR 5.7m in 2016 as the consequence of an overall increase in commercial product volumes. Operating expenses excluding cost of sales amounted to 58.0m in 2017 versus EUR 58.2m in 2016 as the result of a decrease in research and development ('R&D') expenses that was offset by higher expenses for marketing and distribution and general and administrative expenses ('G&A').
R&D expenses amounted to EUR 39.6m in 2017 versus EUR 42.1m in 2016. This represents a year-over-year decrease of approx. 6% driven by amongst others lower expenses for staffing and subcontracting as well as depreciation costs that were partially offset by higher Idylla™ platform and cartridge prototype costs and increased expenses for facilities and consultants. Marketing and distribution expenses amounted to EUR 11.6m in 2017 compared to EUR 10.3m in 2016, a year-over year increase of approx. 12%. This increase is a consequence of additional operational expenses incurred in relation to the US commercialization of the Idylla™ platform that were partially offset by lower sales & promotional and consultancy expenses. G&A expenses amounted to EUR 6.8m in 2017 compared to EUR 5.8m in 2016 being a year-over-year increase of approx. 17% as a result of higher costs for staffing (including share based payment expenses) and external advice.
The above resulted in an operational result for the period of EUR -43.6m compared to EUR -50.2m in 2016, a yearover-year improvement of approx. 13%.
Net financial expenses amounted to EUR 1.7m in 2017 compared to EUR 0.6m in 2016. This increase is driven by amongst others higher financial expenses for debt facilities that were obtained mid-2016 and which are now expensed for on a full-year basis. As the Company had no taxable income in 2017, income tax expense consists of recognized research and development tax credits in Belgium. These increased to EUR 3.4m in 2017 versus EUR 1.0m in 2016 as the consequence of amongst others an adjusted fiscal treatment of certain historical IP investments. Recognized research and development tax credits in Belgium increased with EUR 3.4m in 2017 from EUR 1.0m in 2016 as a consequence of an adjusted fiscal treatment for certain historical IP investments.
As a result of the foregoing the net result for the year 2017 amounted to EUR -42.0m compared to EUR -49.8m in 2016.
In 2017, property plant & equipment increased with EUR 3.1m to EUR 26.2m driven by additions of EUR 7.4m and depreciation charges for the period of EUR 4.3m. Additions predominantly consisted of new manufacturing equipment for cartridge manufacturing as well as capitalization of instrumentation placed at clients under leasing or rental contracts as well as instrumentation held for internal needs.
Inventory amounted to EUR 9.1m as per end 2017 compared to EUR 9.8m as per end 2016. This decrease yearover-year was driven by lower inventory levels of raw materials and semi-finished products, partially offset by a higher inventory level of finished products. Trade receivables increased to EUR 6.9m as per year-end 2017 (EUR 2.9m end of 2016) as a consequence of amongst others invoicing to strategic partners in Q4 in light of new collaboration as well as higher overall commercial volumes.
The Company's cash and cash equivalents end of 2017 amounted to EUR 112.8m compared to EUR 83.2m end of 2016.
Total financial debt amounted to EUR 35.4m as per end of 2017 versus EUR 31.4m as per end of 2016, representing an increase of EUR 4.0m. This increase was predominantly driven by increased uptakes on lease financing facilities to finance the ongoing cartridge manufacturing expansion as well as the addition of capitalized interest to the Company's subordinated loan.
18 The Flanders organization for Innovation & Entrepreneurship.
Trade payables end of 2017 amounted to EUR 5.6m, representing a decrease of EUR –0.7m compared to the EUR 6.3m that was outstanding end of 2016. Deferred income increased in 2017 to EUR 2.8m (EUR 2.1m end of 2016) as a consequence of payments received in relation to new collaborations signed in 2017 as well as the addition of grants.
The cash flow from operating activities amounted to EUR -41.4m in 2017 compared to EUR -53.3m in 2016 driven by an improved operational result for the period in combination with lower investments in working capital in 2017 compared to 2016.
The cash flow from investing activities in 2017 amounted to EUR –4.3m compared to EUR -9.3m in 2016 and included predominantly capitalization of Idylla™ instrumentation and higher investments in intangible assets, mainly consisting of software and IP licenses.
The cash flow from financing activities in 2017 amounted to EUR 75.3m compared to EUR 41.8m in 2016 and predominantly consists of the net proceeds from the capital raise of November 2017 that was partially offset by some repayment on borrowings.
Driven by the aforementioned, the total net cash flow in 2017 amounted to EUR 29.5m compared to EUR -20.9m in 2016.
Biocartis will host a conference call with live webcast, during which the 2017 results will be presented, followed by a Q&A session. This event will be held today, 1 March 2018 at 14:00 CET / 13:00 BST (UK) / 08:00 EDT (US). Access the webcast by clicking here. If you would like to participate in the Q&A, please dial +44 (0)330 336 9105 (standard international) with confirmation code 8419378. A replay of the webcast will be available on the Biocartis investors' website shortly after.
The consolidated financial statements have been prepared in accordance with IFRS, as adopted by the EU. The financial information included in this press release is an extract from the full IFRS consolidated financial statements, which will be published on 5 April 2018. The statutory auditor, Deloitte Bedrijfsrevisoren /Reviseurs d'Entreprises, represented by Gert Vanhees, has confirmed that its audit procedures, which have been substantially completed, have not revealed any material adjustment that should be made in the accounting information included in this press release.
| Years ended 31 December, | ||
|---|---|---|
| In EUR 000 | 2017 | 2016 |
| Revenue | ||
| Collaboration revenue | 7,739 | 5,278 |
| Product sales revenue | 12,936 | 6,767 |
| Service revenue | 282 | 53 |
| 20,957 | 12,098 | |
| Other operating income | ||
| Grants and other income | 2,153 | 1,674 |
| Total operating income | 23,110 | 13,772 |
| Operating expenses | ||
| Cost of sales | -8,673 | -5,701 |
| Research and development expenses | -39,594 | -42,091 |
| Marketing and distribution expenses | -11,600 | -10,324 |
| General and administrative expenses | -6,832 | -5,827 |
| -66,699 | -63,943 | |
| Operating loss for the period | -43,589 | -50,171 |
| Financial income | -2 | 86 |
| Financial expense | -1,714 | -674 |
| Foreign exchange gains/(losses), net | -20 | 2 |
| Financial result, net | -1,736 | -586 |
| Loss for the year before taxes from continuing | ||
| operations | -45,325 | -50,757 |
| Income taxes | 3,365 | 980 |
| Loss for the year after taxes from continuing operations | -41,960 | -49,777 |
| Gain (loss) for the year after taxes from discontinued operations | 0 | 0 |
| Loss for the year | ||
| -41,960 | -49,777 | |
| -41,960 | -49,777 | |
| Attributable to owners of the Company Attributable to non-controlling interest |
||
| Earnings per share | ||
| Basic and diluted loss per share from continuing operations | -0.93 | -1.21 |
| Years ended 31 December, | ||
| In EUR 000 | 2017 | 2016 |
| Loss for the year | -41,960 | -49,777 |
| Actuarial gain (loss) on defined benefit plan | 45 | 19 |
| Tax impact actuarial gain (loss) | -15 | -6 |
| Total comprehensive loss for the year | 0 | |
| -41,930 | -49,764 | |
| -41,930 | -49,764 | |
| Attributable to owners of the Company Attributable to non-controlling interest |
0 | 0 |
| As of 31 December, | |||
|---|---|---|---|
| In EUR 000 | 2017 | 2016 | |
| Assets | |||
| Non-current assets | |||
| Intangible assets | 10,267 | 9,921 | |
| Property plant and equipment | 26,199 | 23,088 | |
| Participating interests | 5,052 | 5,052 | |
| Other long term receivables | 11 | 11 | |
| Deferred tax assets | 6,572 | 3,090 | |
| 48,102 | 41,162 | ||
| Current assets | |||
| Inventory | 9,060 | 9,829 | |
| Trade receivables | 6,892 | 2,935 | |
| Other receivables | 2,856 | 2,201 | |
| Other current assets | 1,517 | 1,932 | |
| Cash and cash equivalents* | 112,765 | 83,246 | |
| 133,090 | 100,143 | ||
| Total assets | 181,191 | 141,305 | |
| Equity and liabilities | |||
| Capital and reserves | |||
| Legal share capital | 511 | 446 | |
| Historical share capital adjustment | -221,232 | -221,232 | |
| Share premium | 630,670 | 554,065 | |
| Share based payment reserve | 2,381 | 1,716 | |
| Accumulated deficit | -280,046 | -238,088 | |
| Other comprehensive income | -45 | -19 | |
| Total equity attributable to owners of the Company | 132,239 | 96,889 | |
| Non-current liabilities Provisions |
16 | 47 | |
| Financial debt | 31,359 | 27,709 | |
| Deferred income | 10 | 142 | |
| Accrued charges | 1,767 | 1,610 | |
| 33,152 | 29,508 | ||
| Current liabilities Financial debt |
4,029 | 3,698 | |
| Trade payables | 5,555 | 6,293 | |
| Deferred income | 2,777 | 1,963 | |
| Other current liabilities | 3,439 | 2,954 | |
| 15,800 | 14,908 | ||
| Total equity and liabilities | 181,191 | 141,305 |
*Cash and cash equivalents for 31 December 2017 include EUR 1.2 million restricted cash related to KBC Lease financing
| Consolidated Cash Flow Statement | Years ended 31 December, | |||
|---|---|---|---|---|
| In EUR 000 | 2017 | 2016 | ||
| Operating activities | ||||
| Loss for the period | -41,960 | -49,777 | ||
| Adjustments for | ||||
| Depreciation and amortization | 5,096 | 4,848 | ||
| Impairments | 0 | 207 | ||
| Tax income in profit and loss | -3,365 | -980 | ||
| Financial result, net | 1,736 | 813 | ||
| Net movement in retirement benefit obligation | -31 | 47 | ||
| Share based payment expense | 665 | 371 | ||
| Other comprehensive income | -38 | -28 | ||
| Changes in working capital | ||||
| Net movement in inventories | 769 | -3,991 | ||
| Net movement in trade and other receivables and other current assets | -4,197 | 1,105 | ||
| Net movement in trade payables & other current liabilities | -95 | -2,659 | ||
| Net movement in deferred income | 682 | -3,049 | ||
| Interest & other financial expenses paid | -562 | -105 | ||
| -41,300 | -53,198 | |||
| Taxes paid | -105 | -114 | ||
| Cash flow used in operating activities | -41,405 | -53,312 | ||
| Investing activities | ||||
| Interest received | -2 | 79 | ||
| Purchases of property, plant & equipment | -3,157 | -9,123 | ||
| Purchases of intangible assets | -1,161 | -1,927 | ||
| Proceeds from sale and lease back of property, plant and equipment | 0 | 1,629 | ||
| Cash flow from / (used in) investing activities | -4,320 | -9,342 | ||
| Financing activities | ||||
| Proceeds from borrowings | 0 | 15,000 | ||
| Proceeds from the lease financing of property, plant and equipment | 0 | 3,978 | ||
| Net proceeds from the issue of common shares, net of transaction costs | 76,669 | 31,398 | ||
| Repayment of borrowings | -1,375 | -8,539 | ||
| Bank charges | -38 | -33 | ||
| Cash flow from financing activities | 75,256 | 41,804 | ||
| Net increase / (decrease) in cash and cash equivalents | 29,531 | -20,850 | ||
| Cash and cash equivalents at the beginning of the period | 83,246 | 104,087 | ||
| Effects of exchange rate changes on the balance of cash held in foreign currencies | -12 | 10 | ||
| Cash and cash equivalents at the end of the period* | 112,765 | 83,247 |
*Cash and cash equivalents for 31 December 2017 include EUR 1.2 million restricted cash related to KBC Lease financing
| In EUR 000 | Legal share capital |
Historical share capital adjustment |
Share premium |
Share based payment reserve |
Gains & losses on defined benefit plans |
Accumulated deficit |
Total equity attributable to the owners of the Company |
Total equity |
|---|---|---|---|---|---|---|---|---|
| Balance as at 1 January 2016 | 405 | -221,232 | 522,707 | 1,345 | 0 | -188,310 | 114,916 | 114,916 |
| Loss for the period | -49,777 | -49,777 | -49,777 | |||||
| Other comprehensive income | -19 | -19 | -19 | |||||
| Total comprehensive income | ||||||||
| Share issue - exercise of stock options on 7 April 2016 | - | - | - | - | -19 | -49,777 | -49,796 | -49,796 |
| Share issue - private placement 21 November 2016 | 366 | 366 | 366 | |||||
| Cost related to private placement | 32,634 | 32,634 | 32,634 | |||||
| Share-based payment expense | 41 | -1,642 | -1,601 | -1,601 | ||||
| 371 | 371 | 371 | ||||||
| Balance as at 31 December 2016 | 446 | -221,232 | 554,065 | 1,716 | -19 | -238,088 | 96,889 | 96,889 |
| Balance as at 1 January 2017 | 446 | -221,232 | 554,065 | 1,716 | -19 | -238,088 | 96,889 | 96,889 |
| Loss for the period | ||||||||
| Other comprehensive income | -41,960 | -41,960 | -41,960 | |||||
| Total comprehensive income | -26 | 0 | -25 | -25 | ||||
| Share-based payment expense | -26 | -41,960 | -41,985 | -41,985 | ||||
| Share issue - exercise of stock options on 5 October 2017 | 665 | 665 | 665 | |||||
| Share issue - private placement 28 November 2017 | 0 | 176 | 176 | 176 | ||||
| Costs related to private placement | 64 | 79,936 | 80,000 | 80,000 | ||||
| Share issue - exercise of stock options on 21 December 2017 | -3,771 | -3,771 | -3,771 | |||||
| Consolidation translation difference | 0 | 264 | 264 | 264 | ||||
| 2 | 2 | 2 | ||||||
| Balance as at 31 December 2017 | 511 | -221,232 | 630,670 | 2,381 | -45 | -280,046 | 132,240 | 132,240 |
Renate Degrave Manager Corporate Communications & Investor Relations e-mail [email protected] tel +32 15 631 729 mobile +32 471 53 60 64 @Biocartis\_ www.linkedin.com/Biocartis
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla™ platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis offers fourteen oncology assays and two infectious disease assays in Europe. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.
Certain statements, beliefs and opinions in this press release 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 press release 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 press release, those results or developments may not be indicative of results or developments in future periods. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forwardlooking 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 press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. Biocartis trademark and logo and Idylla™ trademark and logo are used trademarks belonging to Biocartis. This press release 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 press release 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.
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