IRADIMED CORPORATION (NASDAQ:IRMD), the only known provider of
non-magnetic intravenous (IV) infusion pump systems that are
designed to be safe for use during magnetic resonance imaging (MRI)
procedures, today announced financial results for the three months
ended March 31, 2016.
For the first quarter ended March 31, 2016, the Company reported
revenue of $9.0 million, an increase of 28.2% compared to $7.0
million for the first quarter 2015. Net income was $2.3 million for
the first quarter 2016, an increase of 53.4% compared to $1.5
million for the first quarter 2015. Earnings per diluted share
increased 49.1% to $0.19, compared to $0.12 per diluted share for
the first quarter 2015.
The Company reported non-GAAP net income of $2.6 million for the
first quarter ended March 31, 2016, an increase of 53.7% over the
first quarter 2015. Non-GAAP earnings per diluted share increased
49.4% to $0.21 per diluted share for the first quarter 2016,
compared to $0.14 in the first quarter 2015. Free cash flow was
$2.2 million for the quarter ended March 31, 2016, a 119.8%
increase over the first quarter 2015.
Gross profit margin was 81.0% for the first quarter 2016 and
2015. Domestic sales were 87.8% of total revenue for the first
quarter 2016, compared to 90.1% for the first quarter 2015.
Cash and cash equivalents decreased by $3.9 million to $15.5
million during the quarter. The Company repurchased $5.5 million of
its stock during the first quarter 2016.
“I am very pleased with our first quarter financial results and
the start to 2016. Revenue for the quarter grew 28% over last year
and non-GAAP earnings grew 49% over the same period. These are
solid results compared to a stellar first quarter 2015 that
followed the resumption of domestic shipments after the FDA
shipping hold of the last four months in 2014. Also, in the first
quarter 2016, we had one international shipment that failed to make
it through customs due to improper import documents supplied by our
distributor and importer. Had this shipment cleared customs,
revenue would have been closer to the high end of our guidance,”
said Roger Susi, President and Chief Executive Officer of the
Company.
“Product bookings came in as expected during the quarter and we
have made progress towards our full-year sales team expansion
goals. Development of our patient monitor is on track and we
continue to target the second half of the year for its commercial
launch. Subsequent to the quarter, on April 7th, we filed an appeal
with FDA in response to their not substantially equivalent letter.
FDA has now responded to our appeal with a meeting scheduled for
May 2nd. While FDA’s most recent letter denying the 510(k)
application did not withdraw their consent to our continued
marketing of the infusion pump with the DERS system, we cannot
guarantee they will not change their position. As the only MRI
compatible IV infusion pump, FDA in the past agreed with us that
the public health need justified the availability of our pump,”
said Susi.
Financial Guidance
For the second quarter 2016, the Company expects revenue of
approximately $9.6 million to $9.7 million and non-GAAP diluted
earnings per share of $0.21 to $0.22.
The Company increased its non-GAAP earnings guidance for the
full year 2016 and now expects to report non-GAAP diluted earnings
per share of $0.88 to $0.90, an increase from the previous guidance
of $0.83 to $0.85. Full year 2016 revenue guidance was unchanged at
$39.0 million to $40.0 million.
Use of non-GAAP Financial Measures
The Company believes the use of non-GAAP net income, free cash
flow and infrequent income tax items are helpful to our investors.
These measures, which we refer to as our non-GAAP financial
measures, are not prepared in accordance with GAAP. We calculate
non-GAAP net income as net income excluding stock-based
compensation expense, net of tax. Because of varying available
valuation methodologies, subjective assumptions and the variety of
equity instruments that can impact a company’s non-cash expenses,
we believe that providing non-GAAP financial measures that exclude
stock-based compensation expense allow for meaningful comparisons
between our operating results from period to period. We calculate
free cash flow as net cash provided by operating activities less
net cash used in investing activities for purchases of property and
equipment. We consider free cash flow to be a liquidity measure
that provides useful information to management and investors about
the amount of cash generated by our business that can be used for
strategic opportunities, including investing in our business,
making strategic acquisitions, strengthening our balance sheet and
returning cash to our shareholders via share repurchases.
Infrequent tax items are considered based on their nature and are
excluded from the provision for income taxes as these costs or
benefits are not indicative of our normal or future provision for
income taxes. All of our non-GAAP financial measures are important
tools for financial and operational decision making and for
evaluating our operating results.
A reconciliation of the non-GAAP financial measures used in this
release to the most comparable U.S. GAAP measures for the
respective periods can be found in the table later in this release
immediately following the condensed statements of cash flows. These
non-GAAP financial measures should not be considered in isolation
or as a substitute for a measure of the Company’s operating
performance or liquidity prepared in accordance with U.S. GAAP and
are not indicative of net income or cash provided by operating
activities.
Conference Call
IRADIMED has scheduled a conference call to discuss this
announcement beginning at 11:00 a.m. Eastern Time today, April 29,
2016. Individuals interested in listening to the conference call
may do so by dialing 1-844-413-1781 for domestic callers, or
1-716-247-5767 for international callers, and entering the
reservation code 84649088.
The conference call will also be available real-time via the
internet at www.iradimed.com/en-us/investors/index.php and
selecting Events & Presentation. A recording of the call will
be available on the Company’s website following the completion of
the call.
About IRADIMED CORPORATION
IRADIMED CORPORATION is the only known provider of
non-magnetic intravenous (IV) infusion pump systems that are
specifically designed to be safe for use during magnetic resonance
imaging (MRI) procedures. We were the first to develop an infusion
delivery system that largely eliminates many of the dangers and
problems present during MRI procedures. Standard infusion pumps
contain magnetic and electronic components which can create radio
frequency (RF) interference and are dangerous to operate in the
presence of the powerful magnet that drives an MRI system. Our
patented MRidium MRI compatible IV infusion pump system has been
designed with a non-magnetic ultrasonic motor, uniquely-designed
non-ferrous parts and other special features in order to safely and
predictably deliver anesthesia and other IV fluids during various
MRI procedures. Our pump solution provides a seamless approach that
enables accurate, safe and dependable fluid delivery before, during
and after an MRI scan, which is important to critically-ill
patients who cannot be removed from their vital medications, and
children and infants who must generally be sedated in order to
remain immobile during an MRI scan.
MRidium is a trademark of IRADIMED CORPORATION.
For more information please visit www.iradimed.com.
Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Act of 1995,
particularly statements regarding our expectations, beliefs, plans,
intentions, future operations, financial condition and prospects,
and business strategies. These statements relate to future events
or our future financial performance or condition and involve
unknown risks, uncertainties and other factors that could cause our
actual results, level of activity, performance or achievement to
differ materially from those expressed or implied by these
forward-looking statements. The risks and uncertainties referred to
above include, but are not limited to, risks associated with the
Company’s ability to receive clearance of its 510(k) submission,
additional actions by or requests from the FDA (including a request
to cease domestic distribution of products) and unanticipated costs
or delays associated with resolution of these matters; our reliance
on a single product; unexpected costs, expenses and diversion of
management attention resulting from the FDA warning letter;
potential disruptions in our limited supply chain for our products;
a reduction in international distribution as we focus on fulfilling
orders from our U.S. backlog; actions of the FDA or other
regulatory bodies that could delay, limit or suspend product
development, manufacturing or sales; the effect of recalls, patient
adverse events or deaths on our business; difficulties or delays in
the development, production, manufacturing and marketing of new or
existing products and services; changes in laws and regulations or
in the interpretation or application of laws or regulations.
Further information on these and other factors that could affect
the Company’s financial results is included in filings we make with
the Securities and Exchange Commission from time to time. All
forward-looking statements are based on information available to us
on the date hereof, and we assume no obligation to update
forward-looking statements.
IRADIMED
CORPORATIONCONDENSED BALANCE SHEETS
|
March 31, 2016 |
|
December 31,2015 |
|
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash
equivalents |
$ |
15,507,432 |
|
$ |
19,368,114 |
|
Investments |
8,046,287 |
|
7,602,204 |
|
Accounts receivable, net |
4,644,933 |
|
3,863,632 |
|
Inventory, net |
2,786,245 |
|
2,383,158 |
|
Prepaid expenses and other current
assets |
338,221 |
|
317,957 |
|
Prepaid income taxes |
86,196 |
|
273,968 |
|
Deferred income taxes |
338,634 |
|
141,446 |
|
Total current assets |
31,747,948 |
|
33,950,479 |
|
Property and equipment,
net |
1,051,394 |
|
905,622 |
|
Intangible assets,
net |
475,486 |
|
193,243 |
|
Deferred income
taxes |
62,321 |
|
88,398 |
|
Other assets |
113,931 |
|
106,465 |
|
Total assets |
$ |
33,451,080 |
|
$ |
35,244,207 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
1,224,991 |
|
$ |
1,005,460 |
|
Accrued payroll and
benefits |
875,211 |
|
1,288,248 |
|
Other accrued taxes |
21,763 |
|
30,687 |
|
Warranty reserve |
34,538 |
|
34,081 |
|
Deferred revenue |
446,170 |
|
536,924 |
|
Accrued income taxes |
1,002,155 |
|
— |
|
Total current
liabilities |
3,604,828 |
|
2,895,400 |
|
Deferred
revenue |
601,209 |
|
415,782 |
|
Total liabilities |
4,206,037 |
|
3,311,182 |
|
Stockholders’ equity: |
|
|
|
|
Common stock |
1,123 |
|
1,118 |
|
Additional paid-in
capital |
19,853,370 |
|
19,332,023 |
|
Retained earnings |
14,937,180 |
|
12,655,169 |
|
Treasury stock |
(5,505,439 |
) |
— |
|
Accumulated other comprehensive
loss |
(41,191 |
) |
(55,285 |
) |
Total stockholders’
equity |
29,245,043 |
|
31,933,025 |
|
Total liabilities and stockholders’
equity |
$ |
33,451,080 |
|
$ |
35,244,207 |
|
|
|
|
|
|
|
|
IRADIMED
CORPORATIONCONDENSED STATEMENTS OF
OPERATIONS(Unaudited)
|
Three Months Ended
March 31, |
|
|
2016 |
|
2015 |
|
Revenue |
$ |
8,964,153 |
|
$ |
6,991,705 |
|
Cost of revenue |
1,705,797 |
|
1,328,180 |
|
Gross profit |
7,258,356 |
|
5,663,525 |
|
Operating expenses: |
|
|
|
|
General and administrative |
2,259,722 |
|
1,968,017 |
|
Sales and marketing |
1,283,048 |
|
1,088,696 |
|
Research and development |
234,336 |
|
342,301 |
|
Total operating expenses |
3,777,106 |
|
3,399,014 |
|
Income from operations |
3,481,250 |
|
2,264,511 |
|
Other income,
net |
31,778 |
|
46,815 |
|
Income before provision for income
taxes |
3,513,028 |
|
2,311,326 |
|
Provision for income
taxes |
1,231,017 |
|
823,831 |
|
Net income |
$ |
2,282,011 |
|
$ |
1,487,495 |
|
|
|
|
|
|
Net income per share: |
|
|
|
|
Basic |
$ |
0.21 |
|
$ |
0.14 |
|
Diluted |
$ |
0.19 |
|
$ |
0.12 |
|
Weighted average shares
outstanding: |
|
|
|
|
Basic |
11,095,950 |
|
10,906,224 |
|
Diluted |
12,326,108 |
|
11,977,959 |
|
|
|
|
|
|
IRADIMED
CORPORATIONCONDENSED STATEMENTS OF CASH
FLOWS(Unaudited)
|
Three Months Ended
March 31, |
|
|
2016 |
|
2015 |
|
Operating activities: |
|
|
|
|
Net income |
$ |
2,282,011 |
|
$ |
1,487,495 |
|
Adjustments to reconcile net income
to net cash provided by operating activities: |
|
|
|
|
Bad debt expense |
15,686 |
|
43,802 |
|
Provision for excess and obsolete
inventory |
74,946 |
|
8,442 |
|
Depreciation and
amortization |
60,914 |
|
51,309 |
|
Excess tax benefit on the exercise
of stock options |
(56,579 |
) |
(112,433 |
) |
Stock-based compensation |
391,183 |
|
275,031 |
|
Impairment of intangible
assets |
— |
|
55,433 |
|
Loss on sale of
securities |
7,026 |
|
— |
|
Changes in operating assets and
liabilities: |
|
|
|
|
Accounts receivable |
(796,987 |
) |
(1,600,843 |
) |
Inventory |
(478,033 |
) |
(111,675 |
) |
Prepaid expenses and other current
assets |
(23,346 |
) |
72,488 |
|
Other assets |
(4,384 |
) |
(1,996 |
) |
Deferred income taxes |
(179,790 |
) |
(158,510 |
) |
Accounts payable |
219,531 |
|
152,418 |
|
Accrued payroll and
benefits |
(413,037 |
) |
(568,369 |
) |
Other accrued taxes |
(8,924 |
) |
(48,968 |
) |
Warranty reserve |
457 |
|
31,255 |
|
Deferred revenue |
94,673 |
|
405,967 |
|
Accrued income taxes, net of
prepaid income taxes |
1,246,506 |
|
1,075,341 |
|
Net cash provided by operating
activities |
2,431,853 |
|
1,056,187 |
|
Investing
activities: |
|
|
|
|
Purchases of investments |
(728,336 |
) |
— |
|
Proceeds from the sale or
maturities of investments |
300,000 |
|
— |
|
Purchases of property and
equipment |
(199,338 |
) |
(40,294 |
) |
Capitalized intangible
assets |
(289,591 |
) |
(800 |
) |
Net cash used in investing
activities |
(917,265 |
) |
(41,094 |
) |
Financing
activities: |
|
|
|
|
Proceeds from stock option
exercises |
73,590 |
|
191,837 |
|
Income tax benefits credited to
equity |
56,579 |
|
112,433 |
|
Purchases of treasury
stock |
(5,505,439 |
) |
— |
|
Net cash (used in) provided by
financing activities |
(5,375,270 |
) |
304,270 |
|
Net (decrease) increase in
cash and cash equivalents |
(3,860,682 |
) |
1,319,363 |
|
Cash and cash equivalents,
beginning of period |
19,368,114 |
|
9,454,150 |
|
Cash and cash equivalents,
end of period |
$ |
15,507,432 |
|
$ |
10,773,513 |
|
|
|
|
|
|
|
|
IRADIMED
CORPORATIONRECONCILIATION OF NON-GAAP FINANCIAL
MEASURES (UNAUDITED)
Non-GAAP Net Income and Diluted
EPS
|
Three Months Ended
March 31, |
|
|
2016 |
|
2015 |
|
Net income |
$ |
2,282,011 |
|
$ |
1,487,495 |
|
Excluding: |
|
|
|
|
Stock-based compensation expense,
net of tax expense |
274,814 |
|
176,116 |
|
Non-GAAP net income |
$ |
2,556,825 |
|
$ |
1,663,611 |
|
Weighted average shares
outstanding – diluted |
|
12,326,108 |
|
|
11,977,959 |
|
Non-GAAP net income per
share – diluted |
$ |
0.21 |
|
$ |
0.14 |
|
|
|
|
|
|
|
|
Free Cash Flow
|
Three Months Ended March 31,
2016 |
|
Net cash provided by
operating activities |
$ |
2,431,853 |
|
Less: |
|
|
Purchases of property and
equipment |
199,338 |
|
Free cash flow |
$ |
2,232,515 |
|
|
|
|
|
Media Contact:
Chris Scott
Chief Financial Officer
IRADIMED CORPORATION
(407) 677-8022
InvestorRelations@iradimed.com
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