<SEC-DOCUMENT>0000859737-18-000014.txt : 20180912
<SEC-HEADER>0000859737-18-000014.hdr.sgml : 20180912
<ACCEPTANCE-DATETIME>20180912161051
ACCESSION NUMBER:		0000859737-18-000014
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20180912
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20180912
DATE AS OF CHANGE:		20180912

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			HOLOGIC INC
		CENTRAL INDEX KEY:			0000859737
		STANDARD INDUSTRIAL CLASSIFICATION:	X-RAY APPARATUS & TUBES & RELATED IRRADIATION APPARATUS [3844]
		IRS NUMBER:				042902449
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			0930

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36214
		FILM NUMBER:		181066978

	BUSINESS ADDRESS:	
		STREET 1:		250 CAMPUS DRIVE
		CITY:			MARLBOROUGH
		STATE:			MA
		ZIP:			01752
		BUSINESS PHONE:		5082632900

	MAIL ADDRESS:	
		STREET 1:		250 CAMPUS DRIVE
		CITY:			MARLBOROUGH
		STATE:			MA
		ZIP:			01752
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>a8-kxvitaliaupdate91218.htm
<DESCRIPTION>8-K
<TEXT>
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<div><a name="s9B9E3FFC233881E89FFDCA4201487AE9"></a></div><div></div><div><br></div><div style="line-height:120%;"><hr></div><div style="line-height:120%;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">UNITED STATES </font></div><div style="line-height:120%;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">SECURITIES AND EXCHANGE COMMISSION </font></div><div style="line-height:120%;padding-bottom:8px;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">Washington, D.C. 20549 </font></div><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"><br></font></div><div style="line-height:120%;padding-bottom:8px;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">FORM 8-K </font><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">Current Report Pursuant </font></div><div style="line-height:120%;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">to Section 13 or 15(d) of the </font></div><div style="line-height:120%;padding-bottom:8px;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">Securities Exchange Act of 1934 </font></div><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;padding-bottom:8px;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">Date of Report (Date of earliest event reported) September 12, 2018</font></div><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;&#160;</font></div><div style="line-height:120%;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">HOLOGIC, INC. </font></div><div style="line-height:120%;padding-bottom:8px;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">(Exact Name of Registrant as Specified in Its Charter) </font><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">DELAWARE 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style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;height:18px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;height:18px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td></tr><tr><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">1-36214</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">04-2902449</font></div></td></tr><tr><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">(Commission File Number)</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:center;font-size:10pt;"><font 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style="overflow:hidden;height:18px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;height:18px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td></tr><tr><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:center;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">250 Campus Drive, Marlborough, MA</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div 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style="line-height:120%;padding-bottom:6px;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: </font></div><div style="line-height:120%;font-size:10pt;"><div style="padding-left:0px;text-indent:0px;line-height:normal;padding-top:10px;"><table cellpadding="0" cellspacing="0" style="font-family:Times New Roman;font-size:10pt;width:100%;border-collapse:collapse;text-align:left;"><tr><td colspan="3"></td></tr><tr><td style="width:3%;"></td><td style="width:89%;"></td><td style="width:8%;"></td></tr><tr><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#9744;</font></div></td><td 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material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td></tr><tr><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#9744;</font></div></td><td colspan="2" style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:6px;padding-right:2px;"><div style="padding-bottom:6px;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></div></td></tr><tr><td style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#9744;</font></div><div style="text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"><br></font></div></td><td colspan="2" style="vertical-align:top;padding-left:2px;padding-top:2px;padding-bottom:6px;padding-right:2px;"><div style="padding-bottom:6px;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></div></td></tr></table></div></div><div style="line-height:120%;padding-top:8px;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;background-color:#ffffff;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &#167;230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR &#167;240.12b-2).</font></div><div style="line-height:120%;padding-bottom:8px;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;background-color:#ffffff;">Emerging growth company &#9744;</font></div><div style="line-height:120%;padding-bottom:8px;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. &#9744;</font><hr></div><div><br></div><div></div><hr style="page-break-after:always"><div></div><div><br></div><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"><br></font></div><div style="line-height:120%;text-align:left;padding-left:72px;text-indent:-72px;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;"><br></font></div><div style="line-height:120%;padding-bottom:16px;text-align:justify;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;font-weight:bold;">Item 8.01.&#160;&#160;&#160;&#160;Other Events </font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;">On August 13, 2018, Hologic, Inc. (the &#8220;Company&#8221;) issued a Form 8-K describing the decision by its Cynosure division to suspend marketing and distribution of its TempSure&#8482; Vitalia handpieces and single-use probes, and to ask customers to return any Vitalia handpieces and unused probes they had purchased.  Cynosure had launched the Vitalia handpiece and probe under an FDA 510(k) clearance and had been marketing the device for heating of vaginal tissue.</font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;"><br></font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;">This decision was made in response to a public statement made by the FDA and letters it sent to Cynosure and other medical aesthetics companies expressing concerns regarding &#8220;vaginal rejuvenation&#8221; procedures using energy-based devices.  Cynosure received such a letter relating to its MonaLisa Touch</font><font style="font-family:inherit;font-size:11pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:11pt;">&#32;laser. </font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;"><br></font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;">The Company is now providing an update on the financial impact of its actions in advance of meetings with investors at the Morgan Stanley 16</font><font style="font-family:inherit;font-size:11pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">th</sup></font><font style="font-family:inherit;font-size:11pt;">&#32;Annual Global Healthcare Conference later this week.</font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;"><br></font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;">Based on discussions with medical aesthetics customers over the last month, and relative to its financial guidance provided on July 31, 2018, the Company now expects Cynosure revenue in the current fourth quarter of fiscal 2018 to be approximately $15 million less than previously forecast.  This estimate includes lost sales of TempSure Vitalia in the fourth quarter; refunds and rebates associated with prior sales of Vitalia handpieces, unused probes and TempSure systems; and reduced sales of MonaLisa Touch.  </font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;"><br></font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;">However, based on strong revenue trends in other parts of Hologic&#8217;s business in the current quarter to date, the Company is reaffirming its financial guidance provided on July 31, 2018.  Specifically, the Company continues to expect revenue in the fiscal fourth quarter to be in the range of $800 to $815 million.  Since refunds and rebates related to TempSure Vitalia will be recorded as reductions to revenue, which reduce operating income on a dollar-for-dollar basis, the Company now expects earnings per share (EPS) in the fiscal fourth quarter to be at the low end of its previous GAAP and non-GAAP guidance ranges.</font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;"><br></font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;">Hologic cannot yet predict when it will resume selling TempSure Vitalia.  The Company is committed to marketing its products in compliance with FDA requirements and believes a higher level of scrutiny from regulatory authorities will benefit its customers and patients.</font></div><div style="line-height:120%;text-align:left;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;"><br></font></div><div style="line-height:120%;text-align:left;font-size:11pt;"><font style="font-family:inherit;font-size:11pt;font-style:italic;font-weight:bold;">Cautionary Note Regarding Forward-Looking Statements.&#160;</font><font style="font-family:inherit;font-size:11pt;">The information in this Form 8-K contains forward-looking statements that involve certain risks and uncertainties which could cause actual results to differ materially from those expressed or implied by these statements.  Such risks and uncertainties include the number of customers who return product, the views of the FDA regarding product claims and other factors that are described in the filings made by the Company with the SEC, including our Annual Report on Form 10-K. </font><font style="font-family:inherit;font-size:11pt;background-color:#ffffff;">The Company does not undertake to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.</font></div><div><br></div><div></div><hr style="page-break-after:always"><div></div><div><br></div><div style="line-height:120%;text-align:center;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;font-weight:bold;text-decoration:underline;">SIGNATURES</font></div><div style="line-height:120%;text-align:left;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">&#160;</font></div><div style="line-height:120%;text-align:left;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. </font></div><div style="line-height:120%;text-align:left;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">&#160;</font></div><div style="line-height:120%;font-size:12pt;"><div style="padding-left:0px;text-indent:0px;line-height:normal;padding-top:10px;"><table cellpadding="0" cellspacing="0" style="font-family:Times New Roman;font-size:10pt;width:100%;border-collapse:collapse;text-align:left;"><tr><td colspan="5"></td></tr><tr><td style="width:45%;"></td><td style="width:1%;"></td><td style="width:6%;"></td><td style="width:1%;"></td><td style="width:47%;"></td></tr><tr><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;height:18px;font-size:10pt;"><font 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style="font-family:inherit;font-size:10pt;">&#160;</font></div></td></tr><tr><td style="vertical-align:top;padding-left:2px;padding-top:6px;padding-bottom:6px;padding-right:2px;"><div style="padding-bottom:6px;text-align:left;padding-left:16px;text-indent:-16px;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">Date: September 12, 2018</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td colspan="3" style="vertical-align:bottom;padding-left:2px;padding-top:6px;padding-bottom:6px;padding-right:2px;"><div style="padding-bottom:6px;text-align:left;padding-left:16px;text-indent:-16px;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">HOLOGIC, INC.</font></div></td></tr><tr><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;height:16px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td colspan="2" style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;height:16px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td colspan="2" style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;height:16px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td></tr><tr><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:top;padding-left:2px;padding-top:6px;padding-bottom:6px;padding-right:2px;"><div style="padding-bottom:6px;text-align:left;padding-left:16px;text-indent:-16px;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">By:</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:top;border-bottom:1px solid #000000;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="text-align:left;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">/s/ Karleen M. Oberton</font></div></td></tr><tr><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="overflow:hidden;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div></td><td style="vertical-align:bottom;padding-left:2px;padding-top:2px;padding-bottom:2px;padding-right:2px;"><div style="padding-top:6px;padding-left:16px;text-indent:-16px;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">Karleen M. Oberton</font></div><div style="padding-bottom:6px;font-size:12pt;"><font style="font-family:inherit;font-size:12pt;">Chief Financial Officer</font></div></td></tr></table></div></div><div style="line-height:120%;text-align:left;font-size:8pt;"><font style="font-family:inherit;font-size:8pt;"><br></font></div><div style="line-height:120%;text-align:left;font-size:8pt;"><font style="font-family:inherit;font-size:8pt;"><br></font></div><div><br></div><div></div>	</body>
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