This exceeds previously issued full year 2018 revenue guidance of between $51.0 and $52.5 million. Preliminary fourth quarter 2018 U.S. NeuroStar Advanced Therapy revenue of approximately $4.8 million increased approximately 37% compared with $3.5 million for the fourth quarter of 2017. The increase in U.S. NeuroStar revenue was driven by higher capital revenue growth of 46% due to higher unit sales, partially offset by a 4% decrease in average selling price, as well as lower upgrade and rent-to-own revenue. Preliminary full year 2018 U.S. NeuroStar Advanced Therapy revenue increased approximately 44% to approximately $14.6 million. Preliminary fourth quarter 2018 U.S. treatment session revenue of $9.9 million increased approximately 23% compared with $8.0 million for the fourth quarter of 2017. The increase in U.S. treatment session revenue was primarily the result of an approximate 26% increase in the number of treatment sessions sold, partially offset by an approximate 6% decline in the average selling price due to certain volume pricing discounts within our existing customer base, plus an increase in other treatment session revenue. Preliminary full year 2018 U.S. treatment session revenue increased approximately 24% to approximately $35.3 million.
Monday, January 7, 2019
Inspire Medical reports issuance of positive assessment for therapy by BCBSA
Inspire Medical Systems announced that the Blue Cross Blue Shield Association’s Evidence Street issued a positive assessment of Inspire therapy to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield companies that, when combined, is one of the leading health associations in the U.S. The report summarized that sufficient evidence exists to determine that hypoglossal nerve stimulation results in a meaningful improvement in the net health outcome for patients meeting the following selection criteria.
Clovis reports preliminary Q4 Rubraca sales $30.3M-$30.8M
Clovis Oncology announced its preliminary, unaudited revenues for the fourth quarter and full year ended December 31, 2018. The financial information may be adjusted as a result of completion of customary quarterly review and audit procedures. Unaudited preliminary results include: $30.3M-$30.8M in Rubraca product revenues for 4Q18 compared to $22.8M for Q318 and $17M for Q417. $95.3M-$95.8M in Rubraca product revenues for FY18 compared to $55.5M for FY17. Free drug was an additional approximately 25% to 27% of overall commercial supply for Q4 and FY18. $518M-$521M in cash, cash equivalents and available-for-sale securities at December 31, 2018. Clovis plans to discuss these results with investors this week at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco.
China Biologic reiterates FY18 outlook
China Biologic reiterated its previously revised full year 2018 forecast. Full year 2018 non-GAAP adjusted income from operations is expected to increase in the range of 0% to 2% in RMB terms and non-GAAP adjusted net income is expected to decrease by 2% to 4% in RMB terms over full year 2017 financial results. Excluding TianXinFu, full year 2018 non-GAAP adjusted income from operations is expected to decrease by 16% to 18% in RMB terms and non-GAAP adjusted net income to decrease by 19% to 21% in RMB terms over full year 2017 financial results. This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.76 = $1.00 based on weighted average quarterly exchange rates in 2017 in translating 2017 financial results, the Company expects that the non-GAAP adjusted income from operations and non-GAAP adjusted net income in USD terms in 2018 will be affected by the foreign currency translation impact.
Xencor regains ex-U.S. commercial rights to XmAb13676 from Novartis
Xencor (XNCR) announced it will regain rights to develop and commercialize XmAb13676, a CD20 x CD3 bispecific antibody, from Novartis (NVS) effective June 20, 2019, due to strategic pipeline reprioritization by Novartis. Xencor granted Novartis co-development and ex-U.S. commercial rights in June 2016 through a collaboration and license agreement to develop and commercialize novel bispecific antibodies, including XmAb13676 and XmAb14045, and to access Xencor’s XmAb bispecific Fc and other Fc technologies. Currently XmAb13676 is being evaluated in an open-label Phase 1, multiple-dose, dose-escalation study to assess its safety, tolerability and preliminary anti-tumor activity in patients with B-cell malignancies, and initial data are expected in 2019.
AtriCure sees FY19 revenue approx. $220M-$228M, consensus $222.8M
Management projects 2019 revenue of approximately $220M to $228M, reflecting growth of approximately 9% to 13% over full year 2018. Adjusted EBITDA, a non-GAAP measure, is projected to be positive for 2019.
SeaSpine sees FY19 revenue $152M-$156M, consensus $153.37M
https://thefly.com/landingPageNews.php?id=28445
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