HeartWare International Reports $50.8 Million In Second Quarter 2013 Revenue;
75% Increase From Second Quarter Of 2012
- U.S. Revenues of $25.1 million, up from $4.2 million in Second Quarter of
2012; Reflects Strong Initial Commercialization of HVAD® Pump in U.S. -
- Conference call today at 8:00 a.m. U.S. E.T. -
FRAMINGHAM, Mass. and SYDNEY, Aug. 8, 2013
FRAMINGHAM, Mass. and SYDNEY, Aug. 8, 2013 /PRNewswire/ --HeartWare
International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less
invasive, miniaturized circulatory support technologies that are
revolutionizing the treatment of advanced heart failure, today announced
revenue of $50.8 million for the second quarter ended June 30, 2013, a 75%
increase compared to $29.1 million in revenue for the same period of 2012.
"Our results for the second quarter reflect positive initial trends in the
commercial launch of the HeartWare^® Ventricular Assist System in the U.S.,
following approval from the Food and Drug Administration (FDA) late last year,
as well as continued strong support from our international customers," said
Doug Godshall, President and Chief Executive Officer. "During the second
quarter, 523 HVAD^® pumps were sold globally, an increase from 318 units in
the second quarter of 2012 and more than our previous high quarterly total of
482 units in the first quarter of 2013."
During the second quarter of 2013, U.S. revenue, which reflects the Company's
second full quarter of U.S. commercialization, was $25.1 million, an increase
of approximately 500% from $4.2 million in the second quarter of 2012.
Revenue from international markets, generated through the sale of 288 units,
was $25.7 million, an increase of approximately 4% from $24.9 million in the
second quarter of 2012.
"With more than 200 customers around the world, including 120 outside of the
U.S., at the end of the second quarter, it continues to be quite gratifying to
see such strong interest from new hospital centers thus far in our commercial
launch," added Mr. Godshall. "Our team has been focused on facilitating the
training of additional U.S. hospitals as part of the continued commercial
launch, and with 33 new sites trained between FDA approval and the end of the
second quarter, we finished the first half of 2013 with 83 customers in the
For the six months ended June 30, 2013, revenues increased approximately 81%
to $100.1 million, compared to $55.4 million in the first six months of 2012.
Currency fluctuations had a less than 1% favorable impact on revenue growth
for both the three and six months ended June 30, 2013 compared to the same
period in 2012.
Total operating expenses for the second quarter of 2013 were $41.4 million, as
compared to $34.2 million in the second quarter of 2012.
Research and development expense was $24.2 million for the second quarter of
2013, as compared to $20.0 million in the same period of 2012. Development
costs are primarily attributable to clinical trial costs and research and
development costs related to advancing HeartWare's pipeline technologies,
including the MVAD^® platform, PAL™ controller and a fully-implantable system,
as well as other early research initiatives.
Selling, general and administrative expenses were $17.2 million in the second
quarter of 2013, compared to $14.2 million in the second quarter of 2012. The
increase in selling, general and administrative expenses reflects expansion of
sales and marketing activities, particularly in the U.S., an overall increase
in corporate infrastructure to support the Company's significant growth, and
implementation of the 2.3% excise tax on the U.S. sales of certain medical
devices which became effective January 1, 2013.
Net loss for the second quarter of 2013 was $12.9 million, or a $0.79 loss per
basic and diluted share, compared to a $22.8 million net loss, or a loss of
$1.61 per basic and diluted share, in the second quarter of 2012. For the six
months ended June 30, 2013, the Company recorded a net loss of $25.9 million,
or a $1.66 loss per basic and diluted share, compared to a $41.6 million net
loss, or a loss of $2.94 per basic and diluted share, in the first six months
At June 30, 2013, the Company had $222.4 million of cash, cash equivalents and
investments, reflecting a net cash decrease from the end of the first quarter
2013 of approximately $6.5 million.
HeartWare will host a conference call on Thursday, August 8, 2013 at 8:00
a.m., U.S. Eastern Daylight Time to discuss the Company's financial results,
highlights from the second quarter and business outlook. The call may be
accessed by dialing 1-877-941-2321 five minutes prior to the scheduled start
time and referencing "HeartWare." For callers outside the U.S., please dial
A live webcast of the call will also be available in the Investor section at
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 Class IIIB / IV 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 35 international 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
HeartWare International, Inc. is a member of the Russell 2000^® and its
securities are publicly traded on The NASDAQ Stock Market and the Australian
HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of
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 commercial launch of the HeartWare^®
Ventricular Assist System in the U.S., continued support from international
customers, progress of clinical trials and post-approval studies, regulatory
status, research and development activities and commercialization strategies.
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. 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:
HeartWare International, Inc.
Phone: +1 508 739 0864
- Tables to Follow-
HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2013 2012 2013 2012
Revenue, net $ 50,836 $ 29,053 $ $ 55,398
Cost of revenue 18,866 12,665 37,646 23,493
Gross profit 31,970 16,388 62,429 31,905
Selling, general and 17,217 14,204 33,704 26,920
Research and development 24,188 20,005 46,330 40,012
Total operating expenses 41,405 34,209 80,034 66,932
Loss from operations (9,435) (17,821) (17,605) (35,027)
Other expense, net (3,499) (4,961) (8,288) (6,600)
Net loss $ $ $ (25,893) $ (41,627)
Net loss per common share — $ $ $ $
basic and diluted (0.79) (1.61) (1.66) (2.94)
Weighted average shares
outstanding — basic and 16,370 14,157 15,619 14,139
HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2013 December 31, 2012
Cash and cash equivalents $ 190,024 $ 85,921
Short-term investments 31,148 16,887
Accounts receivable, net 33,596 25,225
Inventories, net 36,926 38,443
Prepaid expenses and other current 7,031 5,925
Total current assets 298,725 172,401
Property, plant and equipment, net 18,103 19,380
Other assets, net 16,093 14,718
Total assets $ 332,921 $ 206,499
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $ 10,836 $ 12,024
Other accrued liabilities 19,386 22,020
Total current liabilities 30,222 34,044
Convertible senior notes, net 103,618 100,315
Other long-term liabilities 3,889 3,929
Stockholders' equity 195,192 68,211
Total liabilities and $ 332,921 $ 206,499
SOURCE HeartWare International, Inc.
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