HTWR Heartware International, Inc. (MM)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of the Securities Exchange Act of 1934

Date of report (date of earliest event reported): April 30, 2015

 

 

HEARTWARE INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-34256		26-3636023
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

500 Old Connecticut Path

Framingham, MA 01701

(Address of principal executive offices)

Registrant’s telephone number, including area code:

508.739.0950

 

 

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:

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

On April 30, 2015, HeartWare International, Inc. (Nasdaq: HTWR), issued a press release announcing financial results for the quarter ended March 31, 2015. A copy of the release is furnished with this report as Exhibit 99.1.

The information in this Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release issued by HeartWare International, Inc. dated April 30, 2015.

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SIGNATURES

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.

 

				HeartWare International, Inc.
Date: April 30, 2015				By:		/s/ Lawrence J. Knopf
						Name:		Lawrence J. Knopf
						Title:		Senior Vice President, General Counsel and Secretary

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INDEX TO EXHIBITS

 

Exhibit No.		Description
99.1		Press Release issued by HeartWare International, Inc. dated April 30, 2015.

Exhibit 99.1

 

 

HEARTWARE INTERNATIONAL REPORTS $70.0 MILLION

IN FIRST QUARTER 2015 REVENUE

 

•

713 HeartWare® Systems sold worldwide in the first quarter of 2015

 

•

U.S. revenue increased 25% over first quarter of 2014 to $42.2 million

 

•

International revenue of $27.8 million; reflects unfavorable currency trends

 

•

Next-generation MVAD® System targeted for first clinical use in Q2 2015

– Conference call today at 8:00 a.m. U.S. ET –

Framingham, Mass., April 30, 2015 - HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $70.0 million for the first quarter ended March 31, 2015, a five percent increase compared to $66.5 million in revenue for the same period of 2014. Currency fluctuations negatively impacted total revenue growth by approximately $5 million, or nearly eight percentage points, in the first quarter of 2015, as compared to the same period in 2014.

“Continued U.S. commercial expansion drove the second-largest unit sales quarter for HeartWare, although year-over-year U.S. growth was offset by a decrease in international unit sales when compared to the exceptionally strong international sales we achieved in the first quarter of 2014,” said Doug Godshall, President and Chief Executive Officer. “We continue to see enthusiastic support of the HeartWare^® System around the world, with the addition of six international and six U.S. customers during the first quarter, which increases our global customer base to more than 280 hospitals.”

During the first quarter of 2015, 713 HeartWare^® Ventricular Assist Systems were sold globally, which represents a seven percent increase from 665 units sold in the first quarter of 2014. During the quarter, U.S. revenue, generated through the sale of 381 units, was $42.2 million, a 25% increase from $33.8 million in the first quarter of 2014. Revenue from international markets was $27.8 million, a decrease of 15% from $32.7 million in the first quarter of 2014, while international unit sales decreased six percent to 332 units in the first quarter of 2015. International unit sales decreased primarily in distributor territories, which have a greater tendency to fluctuate on a quarterly basis.

“During the quarter, we continued to advance our clinical trials for the HVAD^® System, with enrollment in the supplemental destination therapy study nearing completion; follow-up concluded for our Japan clinical trial; and commencement of HVAD LATERAL, a trial designed to evaluate a less-invasive thoracotomy implant technique,” noted Mr. Godshall. “Regarding our pipeline, we recently completed training with investigators and are eager to commence first implants in the CE Mark study for our next-generation MVAD^® System later this quarter, and we plan to submit our Investigational Device Exemption protocol to FDA for review in the coming weeks.”

“Earlier this month, at the 35^th International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting, investigators from HeartWare’s first destination therapy clinical trial cohort, ENDURANCE, announced that the trial successfully achieved the primary endpoint,” Mr. Godshall continued. “Complementing this result, the volume and scope of other HVAD data were impressive, as multi-center studies from the U.S. and abroad presented more contemporary, real-world data, demonstrating excellent outcomes with advanced heart failure patients.”

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Gross margin percentage improved to 68.5% in the first quarter of 2015, compared to 65.5% in the first quarter of 2014, reflecting lower cost of goods and efficiencies associated with increased manufacturing throughput.

Total operating expenses for the first quarter of 2015 were $55.3 million, as compared to $60.0 million in the first quarter of 2014.

Research and development expense was $31.3 million for the first quarter of 2015, as compared to $32.6 million for the first quarter of 2014. The net decrease of $1.3 million for the three months ended March 31, 2015, as compared to the same period in 2014, resulted primarily from a decrease in overall research and development project expenses of $5.0 million, offset by an increase in clinical and regulatory expenses of $3.7 million, including $2.8 million of incremental outside costs associated with FDA warning letter remediation efforts.

Selling, general and administrative expenses were $21.9 million for the first quarter of 2015, compared to $24.2 million for the first quarter of 2014. The $2.3 million net decrease included a $0.3 million increase in growth-driven headcount and other expenses, offset by a $2.6 million reduction in CircuLite restructuring charges.

Net loss for the first quarter of 2015 was $14.5 million, or a loss of $0.85 per basic and diluted share, compared to a net loss of $19.4 million, or a loss of $1.15 per basic and diluted share, for the first quarter of 2014.

Non-GAAP net loss for the first quarter of 2015 was $9.4 million, or $0.55 per basic and diluted share, compared to a loss of $11.9 million, or $0.70 per basic and diluted share, for the first quarter of 2014. See “Use of Non-GAAP Financial Measures” and “Reconciliation of GAAP to Non-GAAP Net Loss per Common Share.”

At March 31, 2015, HeartWare had approximately $174 million of cash, cash equivalents and investments, compared to approximately $180 million at December 31, 2014.

Conference Call and Webcast Information

HeartWare will host a conference call on Thursday, April 30, 2015 at 8:00 a.m., U.S. Eastern Time to discuss its financial results, highlights from the first quarter and the company’s business outlook. The call may be accessed by dialing 1-877-407-0789 five minutes prior to the scheduled start time and referencing “HeartWare.” Callers outside the U.S. should dial +1-201-689-8562.

A live webcast of the call will also be available in the Investors section of the company’s website (http://ir.heartware.com/). A replay of the conference call will be available through the above weblink immediately following completion of the call.

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. The HeartWare^® Ventricular Assist System features the HVAD^® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 42 countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company’s website at www.heartware.com.

 

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HeartWare International, Inc. is a member of the Russell 2000^® and its securities are publicly traded on The NASDAQ Stock Market.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.

Use of Non-GAAP Financial Measures

HeartWare management supplements its GAAP financial reporting with certain non-GAAP financial measures for financial and operational decision making. For example, we use “non-GAAP adjusted net loss” and “non-GAAP adjusted net loss per common share” to refer to GAAP loss per share excluding certain adjustments such as amortization of intangible assets, impairment charges, purchase accounting and acquisition-related transaction costs, and restructuring and severance costs. These are non-GAAP financial measures under Section 101 of Regulation G under the Securities Exchange Act of 1934, as amended. Management believes that providing this additional information enhances investors’ understanding of the financial performance of the Company’s operations and increases comparability of its current financial statements to prior periods. Non-GAAP measures should not be considered a substitute for measures of financial performance in accordance with GAAP, and they should be reviewed in comparison with their most directly comparable GAAP financial results. Reconciliations of HeartWare’s GAAP to non-GAAP financial measures are provided at the end of this news release under “Reconciliation of GAAP to Non-GAAP Net Loss per Common Share.”

Forward-Looking Statements

This announcement contains forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the: commercialization of the HeartWare^® Ventricular Assist System; timing, progress and outcomes of clinical trials; regulatory and quality compliance; research and development activities and our ability to take advantage of acquired and pipeline technology. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by federal securities laws and the rules and regulations of the Securities and Exchange Commission. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, Item 1A. “Risk Factors” in HeartWare’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. HeartWare may update risk factors from time to time in Part II, Item 1A “Risk Factors” in Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings with the Securities and Exchange Commission.

For further information:

Christopher Taylor

HeartWare International, Inc.

Email: ctaylor@heartware.com

Phone: +1 508 739 0864

-Tables to Follow-

 

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HEARTWARE INTERNATIONAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

		Three Months Ended March 31,
		2015				2014
Revenue, net		$	70,021			$	66,472
Cost of revenue			22,040				22,915
Gross profit			47,981				43,557
Operating expenses:
Selling, general and administrative			21,929				24,232
Research and development			31,267				32,590
Change in fair value of contingent consideration			2,100				3,140
Total operating expenses			55,296				59,962
Loss from operations			(7,315	)			(16,405	)
Other expense, net			(6,988	)			(2,816	)
Loss before taxes			(14,303	)			(19,221	)
Income tax (benefit) expense			232				223
Net loss		$	(14,535	)		$	(19,444	)
Net loss per common share — basic and diluted		$	(0.85	)		$	(1.15	)
Weighted average shares outstanding — basic and diluted			17,193				16,934

 

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HEARTWARE INTERNATIONAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

		March 31, 2015				December 31, 2014
ASSETS
Current assets:
Cash and cash equivalents		$	102,525			$	102,946
Short-term investments			70,354				75,535
Accounts receivable, net			36,566				38,041
Inventories			52,356				54,046
Prepaid expenses and other current assets			7,259				5,975
Total current assets			269,060				276,543
Property, plant and equipment, net			17,020				19,036
Other assets, net			127,640				128,234
Total assets		$	413,720			$	423,813
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	10,674			$	13,322
Other accrued liabilities			33,671				36,589
Total current liabilities			44,345				49,911
Convertible senior notes, net			116,871				114,803
Other long-term liabilities			52,538				50,565
Stockholders’ equity			199,966				208,534
Total liabilities and stockholders’ equity		$	413,720			$	423,813

 

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Reconciliation of GAAP to Non-GAAP Net Loss per Common Share (unaudited) (see explanation of adjustments below)

(in thousands, except per share data)

 

						Three Months Ended March 31,
						2015				2014
GAAP net loss						$	(14,535	)		$	(19,444	)
GAAP net loss per common share – basic and diluted						$	(0.85	)		$	(1.15	)
Adjustments:
Amortization of purchased intangible assets			(a	)
-Selling, general and administrative							84				331
-Research and development							327				—
Acquisition-related contingent consideration adjustments			(b	)			2,100				3,140
Restructuring costs			(c	)
-Selling, general and administrative							467				3,026
-Research and development							2,164				1,026
Total adjustments							5,142				7,523
Non-GAAP adjusted net loss						$	(9,393	)		$	(11,921	)
Non-GAAP adjusted net loss per common share - basic and diluted						$	(0.55	)		$	(0.70	)
Shares used in computing non-GAAP adjusted net loss per common share - basic and diluted							17,193				16,934

 

(a)	Represents amortization of purchased intangible assets related to CircuLite and WorldHeart during the quarters ended March 31, 2015 and March 31, 2014.

(b)	Represents the change in fair value of contingent consideration associated with the acquisition of CircuLite in December 2013.

(c)	Represents certain restructuring costs incurred during the quarter ended March 31, 2015 as follows (in thousands):

 

		Three Months Ended March 31,
		2015				2014
Lease exit charge for HeartWare’s former Massachusetts corporate offices		$	2			$	528
Charges related to CircuLite acquisition:
Lease exit charge for former N.J. corporate offices			465				1,667
Lease exit charge for Aachen, Germany facility			139				—
Contract termination costs			310				688
Employee severance			598				562
Abandoned fixed assets			1,117				607
Total		$	2,629			$	3,524
Total restructuring costs		$	2,631			$	4,052

 

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The terms “non-GAAP adjusted net loss” and “non-GAAP adjusted net loss per common share” refer to GAAP net loss and GAAP net loss per common share excluding certain adjustments such as amortization of purchased intangible assets, impairment charges, purchase accounting and acquisition-related transaction costs, and restructuring and severance costs as follows:

 

1)

We exclude amortization of purchased intangible assets and periodic impairment charges related to long-lived assets from this measure because such charges do not represent what our management believes are the costs of developing, producing, supporting and selling our products and the costs to support our internal operating structure.

 

2)

We exclude purchase accounting adjustments and acquisition-related costs from this measure because they occur as a result of specific events and are not reflective of our internal investments and the ongoing costs to support our operating structure. Purchase accounting adjustments include contingent consideration fair market value adjustments.

 

3)

We exclude restructuring and severance costs from this measure because they tend to occur as a result of specific events such as acquisitions, divestitures, repositioning our business or other unusual events that could make comparisons of long-range trends difficult and are not reflective of our internal investments and the costs to support our operating structure.

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