AngioDynamics (ANGO) Lowers FY12, Q3, Q4 Outlook on Lower NanoKnife Sales
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Price: $15.75 -0.44%
Financial Fact:
Total operating expenses: 41.46M
Today's EPS Names:
BTTX, VAXX, ELYS, More
Financial Fact:
Total operating expenses: 41.46M
Today's EPS Names:
BTTX, VAXX, ELYS, More
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AngioDynamics (Nasdaq: ANGO), updates on FY12 outlook.
Sees Q3 sales of $50.9 - $52.9 million and EPS of 7 to 9 cents from 9 - 11 cents prior. The Street sees EPS of 10 cents and revs of $52.85 million.
Sees Q4 sales of $52.1 - $54.1 million and EPS of 10 - 12 cents from 11 - 13 cents prior. The Street sees revs of $54.73 million and EPS of 12 cents.
Finally, sees FY12 revs of $215.5 - $219.5 million from $218 - $222 million prior and EPS of 41 - 45 cents prior. The Street sees revs of $220.5 million and EPS of 43 cents.
Details:
"The guidance update is due to a software recall for the NanoKnife® System, resulting in a temporary hold on U.S. shipments of the NanoKnife System and probes. The impact is partially offset by a better than expected outlook following the resumption of shipments of the Company's NeverTouch® Procedure Kits used with its VenaCure EVLT® Laser Vein Ablation System.
AngioDynamics has initiated a voluntary recall in the U.S. of the NanoKnife System's Ablation Zone Estimator (AZE) software, including the User's Manual and Troubleshooting Guide. The recall does not impact NanoKnife Systems or sales outside of the U.S. The NanoKnife System has FDA 510(k) clearance for the surgical ablation of soft tissue. AngioDynamics added the AZE feature to the NanoKnife System pursuant to a Letter to File, a process by which companies make modifications to products that were already cleared by the U.S. Food and Drug Administration. The FDA recently indicated that the AZE feature should be the subject of a 510(k) premarket notification submission and clearance. AngioDynamics has decided to remove the AZE feature and expects to resume shipments of the system once this software modification has been completed. The Company has notified U.S. customers they should not use the AZE feature for clinical determination of the ablation zone and it should not be used in the U.S. for treatment planning of the therapy area.
AngioDynamics will be contacting U.S. customers to schedule a software change that removes the AZE feature. The Company has halted U.S. NanoKnife System shipments and currently expects to resume U.S. shipments without the AZE software during the Company's fiscal fourth quarter, which ends on May 31, 2012. The Company expects the NanoKnife System development to reduce NanoKnife System sales in the second half of Fiscal Year 2012 by approximately $3.6 million. In the fiscal second quarter ended November 30, 2011, the NanoKnife® System contributed $3.2 million in worldwide sales, approximately half of which were outside the U.S.
The Company has experienced positive customer response after the resumption of shipments of its NeverTouch® Procedure Kits for use with the VenaCure EVLT® Laser Vein Ablation System, following a voluntarily recall earlier this month due to supplier component nonconformances. The Company anticipates NeverTouch® Fiber sales will increase in the second half of Fiscal Year 2012 by approximately $1.1 million over previous internal estimates. The increased sales will partially offset the anticipated sales reduction for the NanoKnife System. As a result, AngioDynamics has slightly reduced its sales and earnings per share expectations for the third and fourth quarters by $1.1 million and $0.02 and $1.4 million and $0.01, respectively. The Company's revised guidance is indicated in the tables below."
Sees Q3 sales of $50.9 - $52.9 million and EPS of 7 to 9 cents from 9 - 11 cents prior. The Street sees EPS of 10 cents and revs of $52.85 million.
Sees Q4 sales of $52.1 - $54.1 million and EPS of 10 - 12 cents from 11 - 13 cents prior. The Street sees revs of $54.73 million and EPS of 12 cents.
Finally, sees FY12 revs of $215.5 - $219.5 million from $218 - $222 million prior and EPS of 41 - 45 cents prior. The Street sees revs of $220.5 million and EPS of 43 cents.
Details:
"The guidance update is due to a software recall for the NanoKnife® System, resulting in a temporary hold on U.S. shipments of the NanoKnife System and probes. The impact is partially offset by a better than expected outlook following the resumption of shipments of the Company's NeverTouch® Procedure Kits used with its VenaCure EVLT® Laser Vein Ablation System.
AngioDynamics has initiated a voluntary recall in the U.S. of the NanoKnife System's Ablation Zone Estimator (AZE) software, including the User's Manual and Troubleshooting Guide. The recall does not impact NanoKnife Systems or sales outside of the U.S. The NanoKnife System has FDA 510(k) clearance for the surgical ablation of soft tissue. AngioDynamics added the AZE feature to the NanoKnife System pursuant to a Letter to File, a process by which companies make modifications to products that were already cleared by the U.S. Food and Drug Administration. The FDA recently indicated that the AZE feature should be the subject of a 510(k) premarket notification submission and clearance. AngioDynamics has decided to remove the AZE feature and expects to resume shipments of the system once this software modification has been completed. The Company has notified U.S. customers they should not use the AZE feature for clinical determination of the ablation zone and it should not be used in the U.S. for treatment planning of the therapy area.
AngioDynamics will be contacting U.S. customers to schedule a software change that removes the AZE feature. The Company has halted U.S. NanoKnife System shipments and currently expects to resume U.S. shipments without the AZE software during the Company's fiscal fourth quarter, which ends on May 31, 2012. The Company expects the NanoKnife System development to reduce NanoKnife System sales in the second half of Fiscal Year 2012 by approximately $3.6 million. In the fiscal second quarter ended November 30, 2011, the NanoKnife® System contributed $3.2 million in worldwide sales, approximately half of which were outside the U.S.
The Company has experienced positive customer response after the resumption of shipments of its NeverTouch® Procedure Kits for use with the VenaCure EVLT® Laser Vein Ablation System, following a voluntarily recall earlier this month due to supplier component nonconformances. The Company anticipates NeverTouch® Fiber sales will increase in the second half of Fiscal Year 2012 by approximately $1.1 million over previous internal estimates. The increased sales will partially offset the anticipated sales reduction for the NanoKnife System. As a result, AngioDynamics has slightly reduced its sales and earnings per share expectations for the third and fourth quarters by $1.1 million and $0.02 and $1.4 million and $0.01, respectively. The Company's revised guidance is indicated in the tables below."
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