ACCD Guides Q1 Well Below Analysts’ Estimates, ALNY Cuts Outlook, NVCR Braces For Busy Year
The following are some of the biotech companies that posted quarterly earnings and provided a business update on Thursday.
1. ABIOMED Inc. (ABMD) expects its revenue for fiscal year 2023 to grow 11% to 15% on a reported basis compared to fiscal year 2022.
Revenue is expected to range between $1.14 billion and $1.18 billion in fiscal year 2023 compared to $1.03 billion reported in fiscal year 2022. Analysts, on average, are expecting revenue of $1.17 billion for fiscal 2023.
The company posted a non-GAAP net income of $203.53 million or $4.44 per share for fiscal year ended March 31, 2022 compared to $175.07 million or $3.84 per share in the prior year.
Wall Street analysts were looking for earnings of $4.35 per share and revenue of $1.03 billion.
ABMD closed Thursday’s trading at $287.22, up 3.63%.
2. Accolade Inc. (ACCD) has reported a wider-than-expected loss for the fiscal fourth quarter and full year ended February 28, 2022 while revenue for the periods topped analysts’ estimates.
However, the revenue forecast provided by the company for fiscal first quarter ending May 31, 2022, and fiscal year ending February 28, 2023, are well below analysts’ expectations.
For the fiscal first quarter ending May 31, 2022, the company expects revenue between $81 million and $83 million while the consensus analysts’ estimate is $85.91 million. The company’s revenue was $59.5 million for the fiscal first quarter ended May 31, 2021.
For the fiscal year ending February 28, 2023, Accolade anticipates revenue between $350 million and $365 million – well below the consensus analysts’ estimate of $387.39 million. Revenue was $310.0 million for fiscal year 2022.
ACCD closed Thursday’s trading at $11.06, down 9.93%. In after-hours, the stock fell over 30% to $7.74.
3. AC Immune SA (ACIU) has a couple of clinical trial events to watch out for this year.
— A phase 1b/2 trial of ACI-24 anti-Abeta vaccine in patients with Alzheimer’s disease is expected to be initiated in the first half of this year. Data from the phase Ib portion of the trial is anticipated in the second half of this year.
— Top line results from a phase II trial of Crenezumab anti-Abeta antibody in patients with autosomal dominant Alzheimer’s disease are expected in the first half of this year.
— Additional fluid biomarker data from a phase II study of Semorinemab anti-Tau antibody in mild-to-moderate Alzheimer’s disease, dubbed Lauriet, is anticipated in the second half of this year.
— Results from phase II and phase I trials of PI-2620 Tau-PET tracer in AD and progressive supranuclear palsy respectively, are expected in the second half of 2022.
— The company expects to initiate a phase II trial of ACI-7104 anti-a-syn vaccine in early Parkinson’s disease in the second half of this year.
As of March 31, 2022, cash on hand totaled CHF 173.8 million.
ACIU closed Thursday’s trading at $3.42, down 0.87%.
4. Alnylam Pharmaceuticals Inc. (ALNY) has lowered its 2022 guidance range for combined net product revenues based on the first quarter results.
For full year 2022 the company now expects combined net product revenues to range between $870 million and $930 million, down from its prior guidance of $900 million to $1 billion.
Vutrisiran, the company’s investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis, is under FDA review, with a decision expected on July 14, 2022.
The following events are expected in early and mid-2022.
— Topline results from phase III trial of Patisiran in ATTR amyloidosis patients with cardiomyopathy, dubbed APOLLO-B.
— Results from phase II monotherapy study of Cemdisiran in patients with IgA nephropathy.
— Novartis plans to report results from its ORION-3 phase II study of Inclisiran in patients with heterozygous familial hypercholesterolemia or pre-existing atherosclerotic cardiovascular disease on background statin +/- ezetimibe therapy. Inclisiran is being developed by Novartis under a license from Alnylam Pharma.
— Topline results from Part B of a phase I study of ALN-HSD in patients with NASH.
ALNY closed Thursday’s trading at $143.16, down 7.59%.
5. Baxter International Inc. (BAX) expects sales to grow approximately 26% for the second quarter and 23%-24% for full-year 2022, on a reported basis.
The company had reported sales of $3.1 billion for the second quarter of 2021 and $12.8 billion for full-year 2021.
Wall Street analysts, on average, expect the company to report sales of $3.88 billion for the second quarter and $15.9 billion for full-year 2022.
BAX closed Thursday’s trading at $70.80, down 0.38%.
6. GlycoMimetics Inc. (GLYC) has a couple of clinical trial events to watch in the coming months.
The company expects to submit an IND, seeking FDA clearance to initiate a phase I trial for GMI-1687 in sickle cell disease in the first half of 2022.
The lead drug candidate Uproleselan is under a phase III trial in relapsed/refractory AML. GlycoMimetics now anticipates mid-year 2023 for the overall survival events trigger, with top line data disclosure shortly thereafter.
As of March 31, 2022, GlycoMimetics had cash of $76.5 million.
GLYC closed Thursday’s trading at $0.77, down 7.98%.
7. LeMaitre (LMAT), a provider of vascular devices, implants and services, has lowered its sales outlook for full-year 2022 due to a negative impact from the stronger U.S. dollar.
For full-year 2022, the company now expects sales to range between $160.0 million and $164.0 million, down from its prior forecast of $162 million to $166 million. The company had reported sales of $154.4 million in 2021.
Wall Street analysts, on average, expect the company to report sales of $164.75 million for the year.
LMAT closed Thursday’s trading at $45.81, up 2.97%.
8. Novocure (NVCR) expects 2022 to be a transformational period, with a couple of clinical milestones to be achieved.
The following data readouts and events are anticipated this year.
— Data from phase 2 pilot trial evaluating the safety and efficacy of Tumor Treating Fields concomitant with chemotherapy as a first-line treatment in patients with gastric adenocarcinoma, dubbed EF-31.
— Data from phase pilot trial of Tumor Treating Fields delivered utilizing high-intensity arrays in patients with recurrent glioblastoma, dubbed EF-33.
— Last patient enrollment in phase 3 pivotal trial studying radiosurgery plus Tumor Treating Fields compared to radiosurgery alone for the treatment of brain metastases from non-small cell lung cancer, dubbed METIS.
— Data from LUNAR study, a phase III pivotal trial testing the effectiveness of Tumor Treating Fields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 non-small cell lung cancer who progressed during or after platinum-based therapy.
The company’s cash on hand totaled $932.3 million as of March 31, 2022.
NVCR closed Thursday’s trading at $77.18, up 0.30%.
9. Zynex Inc. (ZYXI) an innovative medical technology company, which reported strong Q1 results, expects continued growth during this year.
For the second quarter 2022, revenue is expected to be between $35.0 and $38.0 million, an increase of approximately 18% from the year-ago period.
Looking ahead to full year 2022, the company anticipates revenue to be in the range of $150 million to $170 million. Revenue reported in 2021 was $130.3 million.
Analysts polled by Thomson Reuters are looking for revenue of $37.14 million for Q2, and $159.82 million for full-year 2022.
Cash on hand was $39.2 million as of March 31, 2022.
ZYXI closed Thursday’s trading at $7.14, up 2.44%.
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