Key Developments: HeartWare International Inc (HTWR.O)

HTWR.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

HeartWare International Inc raises Q4 2013 revenue guidance; gives FY 2013 revenue guidance in line with analysts' estimates
Tuesday, 14 Jan 2014 04:45pm EST 

HeartWare International Inc:Says Q4 2013 revenues to be about $53 million.Says FY 2013 revenues to be about $208 million.FY 2013 revenue of $213 million - Thomson Reuters I/B/E/S Estimates.  Full Article

HeartWare International Inc announces acquisition of CircuLite, Inc
Sunday, 1 Dec 2013 09:10pm EST 

HeartWare International Inc:Says that it has acquired CircuLite, Inc. - developer of the SYNERGY Circulatory Support System, designed to treat less sick, ambulatory, chronic heart failure patients who are not yet inotrope-dependent.Says according to the terms of the merger agreement, HeartWare has acquired all of the issued and outstanding equity interests of CircuLite for consideration of $30 mln.Says consideration consist of about $18 mln in common stock and cash of about $12 mln to settle CircuLite's debt and transaction expenses.Says consideration also consist of certain contingent success payments due upon satisfaction of regulatory and commercial milestones not to exceed $320 mln in the aggregate over a 10 year period.  Full Article

HeartWare International Inc Issues Q4 2013 Revenue Guidance Below Analysts' Estimates-Conference Call
Thursday, 7 Nov 2013 08:00am EST 

HeartWare International Inc announced that for fourth quarter of 2013, it expects international year-on-year revenue growth to be north of 20%, not unlike robust international growth in the third quarter of 2013. The Company reported revenue of $32.66 million in fourth quarter of 2012. According to I/B/E/S estimates, analysts were expecting the Company to report revenue of $57.47 million for fourth quarter of 2013.  Full Article

HeartWare International Inc Receives FDA Approval To Enroll Supplemental Patient Cohort In Destination Therapy Trial
Tuesday, 27 Aug 2013 08:00pm EDT 

HeartWare International Inc announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the Company’s pivotal, Destination Therapy clinical study. In this supplemental cohort, HeartWare will enroll up to 286 patients receiving the HeartWare Ventricular Assist System, as well as up to an additional 143 control patients using a randomization scheme consistent with the ENDURANCE protocol. Patients will be followed for 12 months after implant. HeartWare intends to incorporate the data from both this new cohort and ENDURANCE into an anticipated Pre-Market Approval (PMA) Application seeking approval of the HeartWare System for the Destination Therapy indication. The protocol for this cohort is designed to confirm clinical observations that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events. Patient enrollment can commence at the 50 centers participating in the ENDURANCE clinical trial, following Institutional Review Board approvals at each of the centers.  Full Article

HeartWare International Inc Does Not Declare Dividend
Sunday, 11 Aug 2013 07:48pm EDT 

HeartWare International Inc announced that the directors do not recommend that a dividend relating to the interim period ended June 30, 2013 be paid.  Full Article

HeartWare International Inc Issues H2 2013 Revenue Guidance In Line With Analysts' Estimates-Conference Call
Thursday, 8 Aug 2013 08:00am EDT 

HeartWare International Inc announced that it anticipate overall revenue should modestly increase in the second half of 2013 as compared to the first half of 2013, and that the increase will be weighted towards the fourth quarter of 2013 as the Company regain traction with these key patient implants. The Company also recognize that the third quarter of 2013 can be less predictable due to potential summer activity slowdown in international markets. The Company reported revenue of $49.24 million in first quarter of 2013 and revenue of $50.84 million in second quarter of 2013. According to I/B/E/S estimates, analysts were expecting the Company to report revenue of $51.49 million for third quarter of 2013; revenue of $57.12 million for fourth quarter of 2013.  Full Article

HeartWare International Inc Receives Conditional Approval From FDA To Enroll Supplemental Patient Cohort In Destination Therapy Trial
Monday, 17 Jun 2013 08:50am EDT 

HeartWare International, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval to an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the Company's pivotal, Destination Therapy clinical study. The primary endpoint of the trial is stroke-free (Modified Rankin Score > 4) survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life. The final implant was conducted in May 2012, which will result in the final patient reaching the two-year follow up point in May 2014.  Full Article

HeartWare International Inc Announces Intention To Delist From Australian Securities Exchange
Wednesday, 12 Jun 2013 06:51pm EDT 

HeartWare International Inc announced that it has requested and received approval from ASX Limited for its removal from the official list of ASX. Trading in HeartWare's CHESS Depositary Interests (CDIs) will be suspended on ASX at the close of market on September 10, 2013. HeartWare's shares of common stock are currently listed for trading on the NASDAQ Global Select Market under the symbol HTWR and HeartWare’s CDIs are traded on the ASX under the code HIN. One share of HeartWare common stock is equivalent to 35 CDIs. ASX has advised that in accordance with the Company's request, it will remove the Company from the official list of ASX with effect from the close of trading on September 17, 2013 subject to HeartWare providing a voluntary sale facility through which holders of CDIs may sell their shares of common stock on NASDAQ (as described below) and notifying CDI holders of the availability of the sale facility. HeartWare's common stock will continue to be listed on NASDAQ.  Full Article

HeartWare International Inc Announces Closing Of Public Offering Of Common Stock
Monday, 18 Mar 2013 08:10pm EDT 

HeartWare International Inc announced the completion of a public offering of 1,725,000 shares of common stock, at a price per share of $86.45 pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on December 9, 2010. This amount includes 225,000 additional shares of common stock sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares of common stock to cover over-allotments. HeartWare intends to use the net proceeds from the offering for working capital and general corporate purposes, including, but not limited to, research and development, expansion of manufacturing capabilities, selling and marketing activities, capital investments in information systems, facilities and infrastructure, and general and administrative support functions to support growth and the acquisition or licensing of or investment in complementary products, technologies or businesses. J.P. Morgan Securities LLC acted as the sole book-running manager for the offering. Canaccord Genuity Inc., Credit Suisse Securities (USA) LLC and Lazard Capital Markets LLC acted as co-managers of the offering. Perella Weinberg Partners served as independent capital markets advisor to HeartWare on this offering.  Full Article

HeartWare International Inc Announces Closing of Public Offering of Common Stock
Monday, 18 Mar 2013 12:21pm EDT 

HeartWare International Inc announced the completion of a public offering of 1,725,000 shares of common stock, at a price per share of $86.45 pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on December 9, 2010. This amount includes 225,000 additional shares of common stock sold pursuant to the underwriters' exercise in full of their option to purchase additional shares of common stock to cover over-allotments. HeartWare intends to use the net proceeds from the offering for working capital and general corporate purposes, including, but not limited to, research and development, expansion of manufacturing capabilities, selling and marketing activities, capital investments in information systems, facilities and infrastructure, and general and administrative support functions to support growth and the acquisition or licensing of or investment in complementary products, technologies or businesses. J.P. Morgan Securities LLC acted as the sole book-running manager for the offering. Canaccord Genuity Inc., Credit Suisse Securities (USA) LLC and Lazard Capital Markets LLC acted as co-managers of the offering. Perella Weinberg Partners served as independent capital markets advisor to HeartWare on this offering.  Full Article

UPDATE 1-Medical device maker HeartWare gets FDA warning letter

June 4 - HeartWare International Inc said it received a warning letter from the U.S. Food and Drug Administration following an inspection of its manufacturing plant in Florida in January.

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