Company News: Curetis Publishes Full-Year 2015 Financial Results and Introduces 2016 Guidance

– Company successfully completed IPO on Euronext Amsterdam and Euronext Brussels, raising EUR 44.3 million
– Accelerated global commercialization lays strong foundation for future growth

Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced financial results for the twelve months ended December 31, 2015 and provided details on its outlook for 2016.

2015 Operational Highlights

  • Through its successful IPO on Euronext Amsterdam and Euronext Brussels, raised EUR 44.3 million, including the exercise of the overallotment option.
  • Significantly strengthened commercial capabilities by appointing Dr. Achim Plum as Chief Commercial Officer and expanding its direct sales channels beyond the DACH region (Germany, Austria, Switzerland) to also cover the UK, France and Benelux. Expanded commercial team to 12 members to facilitate broader direct sales efforts as well as marketing and business development support.
  • Entered major Asian markets through partnerships with Beijing Clear Biotech (BCB) for Mainland China, Hong Kong and Taiwan and with Singapore-based Acumen for ASEAN markets, which will initially include Singapore, Malaysia, Thailand and Indonesia.
  • As of the end of 2015, the Company has significantly grown the installed base of Unyvero Analyzers to 103, a 78% increase from an installed base of 58 at the end of 2014.
  • Partnered with an undisclosed major pharmaceutical company for a Phase III Amikacin drug trial. In this trial, Unyvero is being used for pathogen identification and patient inclusion at multiple clinical sites across Europe.

2015 Financial Highlights

  • Revenues: EUR 2.1 million (EUR 0.3 million in 2014).
  • Expenses: EUR 14.3 million total cost of sales, distribution costs, administrative expenses and research & development expenses (EUR 10.5 million in 2014). The increase was mainly due to the increase in valuation of Phantom Stock Options (PSOs).
  • Operating result: EUR 12.1 million (EUR 10.1 million in 2014).
  • Net profit / Net loss: EUR 13.8 million (net loss of EUR 12.4 million in 2014). The difference is mainly due to financial income totaling EUR 25.9 million net, which primarily resulted from a one-time IFRS accounting entry related to the changes in fair value measurement of the preferred and common shares of Curetis AG, which was triggered by the corporate reorganization of the Company.
  • Cash & cash equivalents: EUR 46.1 million as of Dec. 31, 2015 (EUR 3.0 million on December 31, 2014).
  • Net cash burn from operating activities: EUR 8.5 million (EUR 7.4 million in 2014).
  • Net cash burn from investing activities: EUR 1.1 million (EUR 1.6 million in 2014).

Anticipated Milestones

  • Based on current forecasts and expansion plans, Curetis anticipates that the Unyvero Installed Base will grow to 150 to 200 systems at the end of 2016, adding between 50 and 100 new Unyvero Analyzers globally to the installed base during the year.
  • Curetis will add multiple new Application Cartridges to the portfolio of the Unyvero Solution and accelerate its development pipeline in 2016 and 2017. During ECCMID 2016, the Company launched its Unyvero BCU (Blood Culture) Cartridge as a CE-IVD marked product in Europe. Furthermore, the Company expects to launch a second generation of its ITI (implant and tissue infection) Application Cartridge in mid-2016. Toward the end of 2016, the Company anticipates the completion of product development for an IAI panel (intra-abdominal infection) and in late 2017, development of a Sepsis Host Response Application Cartridge.
  • In 2016, Curetis expects its US clinical trial to progress toward completion. With more than 1,600 patient samples already enrolled and successfully tested by the end of March 2016, the Company believes that it will complete enrolment by mid-year and expects to be in a position to submit its application for US FDA clearance of Unyvero in the second half of 2016. The Company aims for FDA clearance of its Unyvero LRT55 product in the first half of 2017, provided that the FDA trial will be successfully completed in 2016.
  • In line with the expected US FDA clearance, the Company intends to build its own direct US marketing and sales organization, beginning with the recruitment of a core team in the second half of 2016. An executive search for the US General Manager / US CEO is currently ongoing.
  • The Company expects that its partner BCB will drive toward completion of its CFDA trial in China by early 2017. BCB has expressed its goal to obtain CFDA clearance in 2017 and to begin commercialization in mainland China thereafter. Commercial efforts in Hong Kong and Taiwan, which are not subject to first obtaining CFDA approval, have already begun with initial installations at major hospitals expected during 2016.

Commenting on Curetis’ 2015 results, Oliver Schacht, CEO of the Company stated: “The year 2015 was extremely successful for Curetis. Based on the three-pronged strategy of expanding Curetis’ commercial presence in Europe, building our own direct US commercial presence and accelerating our Unyvero product development pipeline, we were able to up-size our IPO in November by more than 50% compared to our original target. Throughout 2015 and into 2016 we have begun executing on our strategic plans and further developing our equity story in line with what we communicated during our IPO. Key additions to our commercial team have been made and we expect to continue growing our sales and marketing capabilities. With a very solid cash position of more than 46 million Euros going into 2016, we are well positioned to continue executing this year, and well into the future.”

“At a macro level, Unyvero is beginning to make an impact on how critically ill patients with infectious diseases in hospitals get diagnosed and treated with antibiotics,” Schacht added. “Unyvero contributes to personalizing medicine, and empowers clinicians to make rational antibiotic treatment decisions for patients in life-threatening situations.”

For the twelve months ended December 31, 2015, revenues were EUR 2.1 million, a substantial increase over revenues of EUR 0.3 million in 2014. The strong revenue growth was primarily attributable to a 78% increase in the installed base of Unyvero Analyzers, which totaled 103 at the end of 2015, compared to 58 as of the end of 2014.

Gross loss for the year totaled EUR 0.07 Million, compared with a gross loss of EUR 0.37 Million in 2014. The gross loss was primarily attributable to significant revenues from Unyvero system sales in 2015 at very low or no margins, as well as discounted pricing of Unyvero cartridges sold to distribution partners for clinical trials. Also, under IFRS accounting the cost of goods for the Unyvero cartridges still include significant elements of as-yet unutilized capacity to allow for future expansion in manufacturing output. Full-year 2015 gross margin was -3.5%, compared with -134% for 2014.

Operating loss in 2015 totaled EUR 12.1 million, compared with EUR 10.1 million in 2014. The increased operating loss was mainly related to acceleration of the Company’s commercial expansion and an increase in valuation of the PSOs resulting from the IPO.

Net income for the year was EUR 13.8 million compared with a net loss of EUR 12.4 million in 2014. Full-year 2015 net income included financial income of EUR 25.9 million net, mainly relating to the changes in fair value measurement of the preferred and common shares of Curetis AG, which was triggered by the corporate reorganization of the Company in preparation for its IPO in November 2015.

At the end of 2016, the Company expects a strong cash position of EUR 31 to 32 million cash on hand and a net cash burn of EUR 14 to 15 million throughout the year for all operating and investment activities combined.