inspirator schreef op 20 augustus 2016 17:26:
Revenues
Total company revenues for the first six months ended June 30, 2016, increased 65% to $12.9 million, compared to total revenues of $7.9 million for the prior year. ConfirmMDx for Prostate Cancer accounted for 83% of the Company’s revenue in H1 2016, compared to 88% in H1 2015. The growth in Q2 2016 revenues compared to the prior period was principally driven by increased sales of ConfirmMDx as well as royalty and milestone payments from Exact Sciences. The SelectMDx for Prostate Cancer assay, still in the early stages of commercialization, contributed less than 1% of total revenue.
Operating Expenses
Operating expenses for the first six months ended June 30, 2016 increased by $5.5 million to $16.0 million from $10.5 million for the prior year. The year-over-year increase is attributed to increased material costs related to growing ConfirmMDx test volume, expanded laboratory operations, investment in capital equipment and infrastructure to augment increasing ConfirmMDx sales, EU operations, and spending related to the build-up for US and European commercialization of the SelectMDx test, as well as the manufacturing set-up for the SelectMDx CE-marked IVD kit and one-off corporate development projects. During H1, investment in the European and US commercial infrastructure, including laboratory equipment and operations, information technology and expansion of managed care, billing and collections staff, contributed to increased operating expenses. The investment in commercial operations was made to support anticipated volume growth and to support reimbursement efforts.
Results
The Company's net loss for the first six months ended June 30, 2016, was $7.6 million, or ($0.17) a share, compared to a loss of $5.5 million loss, or ($0.12) a share, for the prior year. The $2.1 million increase in net loss compared to the same period last year is due to the anticipated initial losses of the newly acquired Dutch entity NovioGendix, laboratory investments related to the new SelectMDx for Prostate Cancer assay, and non-recurring corporate development spending in the first half.
Cash Position
The Company’s cash and cash equivalents were $20.1 million on June 30, 2016, compared to $40.4 million on June 30, 2015. Collections from ConfirmMDx reimbursements were $8.2 million in 2016 vs. $5.3 million in the first half of 2015. Average net cash burn in the first six months of 2016 was approximately $1.9 million per month.
Justification to continue using the accounting rules on the basis of going concern
Despite cumulated losses, the Board has decided to continue to apply the accounting rules on the basis of going concern. This decision is justified by (i) the success of the technology of the Company in various cancer applications and scientific publications, (ii) continued interest in the Company’s technology, (iii) the continued industry growth in the field of molecular diagnostics and personalized medicine, and (iv) the fact that sufficient cash is available to support further development of the Company’s products over the next 12 months period in function of the current business plan. Considering the situation, the Board of Directors believes that there is enough cash to sustain the current projects of the Company at least until the date of the annual general shareholders’ meeting scheduled for May 2017.
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