Allakos announced top-line results for the Xolair-naive chronic spontaneous urticaria cohort from its Phase 2 study. The study is being conducted at 4 sites in the U.S. and Germany. The principle investigator is Dr. Marcus Maurer, MD, Professor of Dermatology and Allergy at Charite University in Berlin. The Xolair-naive chronic spontaneous urticaria cohort enrolled 13 patients with uncontrolled urticaria despite treatment with H1 antihistamines at doses of up to 4 times the labeled dosage. Antihistamine medication was maintained throughout the screening period and during the study. Baseline symptom scores, as measured by Urticaria Control Test and Urticaria Activity Score were collected over a 4-week screening period. Patients with baseline UCT scores of less than 12, indicative of poorly controlled urticaria, were enrolled in the study and treated with up to 6 doses of AK002 given once monthly. Patients received an initial dose of 0.3 mg/kg at baseline, followed by a dose of 1.0 mg/kg on day 28, and then received monthly doses of either 1.0 or 3.0 mg/kg for a total of 6 doses. The primary efficacy endpoint was change from baseline in UCT assessed at week 22, two weeks after the last dose of AK002.
Monday, January 7, 2019
Diplomat Pharmacy sees FY18 GAAP EPS (8c)-0c, consensus 80c
Lowers FY18 revenue view to $5.5B-$5.6B from $5.5B-$5.7B, consensus $5.56B. 2018 adjusted EBITDA is now expected to be within the range of $167M-$170M, an increase of at least 64% based on the low end of the 2018 range vs. 2017. Prior view was $164M-$170M.
Intersect ENT preliminary FY18 revenue $108.3M-$108.5M; Consensus $107.93M
https://thefly.com/landingPageNews.php?id=2844502
Neuronetics sees FY18 revenue $52.8M, consensus $51.81M
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.
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.
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