iRadimed Corporation (NASDAQ: IRMD), a leader in the development of
innovative magnetic resonance imaging (“MRI”) medical devices and
the only known provider of a non-magnetic intravenous (“IV”)
infusion pump system and non-magnetic patient vital signs
monitoring system that are designed for use during MRI procedures,
today announced financial results for the three months ended March
31, 2019.
For the first quarter ended March 31, 2019, the Company reported
revenue of $8.4 million compared to $7.1 million for the first
quarter 2018. Net income was $1.8 million, or $0.15 per diluted
share, compared to net income of $0.8 million, or $0.07 per diluted
share for the first quarter 2018. Gross profit margin was 75.7
percent, compared to 76.2 percent for the first quarter 2018.
Domestic sales were 83.8 percent of total revenue, compared to 84.1
percent for the first quarter 2018. Revenue from sales of our 3880
MRI compatible patient vital signs monitoring system was $1.8
million for the first quarter 2019 compared to $1.2 million for the
first quarter 2018.
Non-GAAP net income was $1.6 million for the quarter ended March
31, 2019, which excludes $0.3 million of stock compensation
expense, net of tax and a $0.6 million reduction to non-GAAP net
income resulting from an infrequent tax item related to excess tax
benefits recognized in the provision for income taxes for the
exercise and sale of certain incentive stock options. Non-GAAP net
income for the quarter ended March 31, 2018 was $1.2 million, which
excludes $0.3 million of stock compensation expense, net of tax.
Non-GAAP earnings per diluted share was $0.13, compared to $0.10
for the first quarter 2018. Free cash flow was $0.6 million,
compared to $1.5 million for the first quarter 2018.
As of March 31, 2019, the Company had combined cash and
investments of $35.4 million.
“We are pleased with the first quarter results, especially in
light of having had a very strong fourth quarter. The
highlight this quarter was the especially strong growth in IV pump
sales, which we continue to focus on cultivating opportunities as
we simultaneously build on the early successes from our MRI patient
monitor. We look forward to maintaining momentum powered by our
growing sales force and the launch of our third device later this
year,” said Roger Susi, President and Chief Executive Officer of
the Company.
Financial Guidance
This financial guidance includes the expected impact of our CE
Mark expiration as announced on January 22, 2019.
The Company maintains its full year 2019 guidance and expects to
report revenue of $38.5 million to $39.5 million, GAAP diluted
earnings per share of $0.60 to $0.64 and non-GAAP diluted earnings
per share of $0.69 to $0.73.
For the second quarter 2019, the Company expects to report
revenue of $8.8 million to $9.0 million, GAAP diluted earnings per
share of $0.11 to $0.12 and non-GAAP diluted earnings per share of
$0.14 to $0.15.
For the full year ending December 31, 2019, the Company’s
non-GAAP earnings per share guidance excludes stock-based
compensation expense, net of tax, and an infrequent tax item, which
the Company expects to be approximately $1.2 million and $(0.6)
million, respectively. For the second quarter 2019, the Company’s
non-GAAP earnings per share guidance excludes stock-based
compensation expense, net of tax of $0.3 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 allows 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 30,
2019. 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 1156238.
The conference call will also be available real-time via the
internet at http://www.iradimed.com/en-us/investors/events/. 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 a leader in the development of
innovative magnetic resonance imaging (“MRI”) compatible medical
devices. We are the only known provider of a non-magnetic
intravenous (“IV”) infusion pump system that is specifically
designed to be safe for use during 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 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 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 to remain immobile during an MRI scan.
Our 3880 MRI compatible patient vital signs monitoring system
has been designed with non-magnetic components and other special
features to safely and accurately monitor a patient’s vital signs
during various MRI procedures. The IRADIMED 3880 system operates
dependably in magnetic fields up to 30,000 gauss, which means it
can operate virtually anywhere in the MRI scanner room. The
IRADIMED 3880 has a compact, lightweight design allowing it to
travel with the patient from their critical care unit, to the MRI
and back, resulting in increased patient safety through
uninterrupted vital signs monitoring and decreasing the amount of
time critically ill patients are away from critical care units. The
features of the IRADIMED 3880 include: wireless ECG with dynamic
gradient filtering; wireless SpO2 using Masimo® algorithms;
non-magnetic respiratory CO2; non-invasive blood pressure; invasive
blood pressure; patient temperature, and; optional advanced
multi-gas anesthetic agent unit featuring continuous Minimum
Alveolar Concentration measurements. The IRADIMED 3880 MRI
compatible patient vital signs monitoring system has an easy-to-use
design and allows for the effective communication of patient vital
signs information to clinicians.
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 an EC Certificate or CE Mark for our
existing products, receive FDA 510(k) clearance for new products;
unexpected costs, delays or diversion of management’s attention
associated with the design, manufacture or sale of new products;
the Company’s ability to implement successful sales techniques for
existing and future products and evaluate the effectiveness of its
sales techniques; additional actions by or requests from the FDA;
our significant 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;
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, 2019 |
|
December 31,2018 |
|
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and
cash equivalents |
$ |
29,684,457 |
|
$ |
28,027,688 |
|
Accounts
receivable, net |
5,328,550 |
|
4,209,992 |
|
Investments |
5,746,888 |
|
6,349,915 |
|
Inventory,
net |
4,231,504 |
|
4,059,443 |
|
Prepaid
expenses and other current assets |
783,170 |
|
526,787 |
|
Prepaid
income taxes |
1,665,986 |
|
1,367,892 |
|
Total
current assets |
47,440,555 |
|
44,541,717 |
|
Property and equipment,
net. |
1,902,045 |
|
1,869,561 |
|
Intangible assets,
net |
819,752 |
|
832,519 |
|
Operating lease
right-of-use asset. |
3,127,278 |
|
— |
|
Deferred income taxes,
net |
1,017,049 |
|
1,088,702 |
|
Other assets |
106,536 |
|
109,759 |
|
Total
assets |
$ |
54,413,215 |
|
$ |
48,442,258 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts
payable |
$ |
1,180,598 |
|
$ |
772,470 |
|
Accrued
payroll and benefits |
1,423,967 |
|
1,802,321 |
|
Other
accrued taxes |
86,168 |
|
133,000 |
|
Warranty
reserve |
74,183 |
|
74,524 |
|
Deferred
revenue |
1,902,175 |
|
1,798,784 |
|
Current
portion of operating lease liability |
230,271 |
|
— |
|
Other
current liability |
108,421 |
|
108,421 |
|
Total
current liabilities |
5,005,783 |
|
4,689,520 |
|
Deferred revenue |
1,864,348 |
|
1,807,005 |
|
Operating lease
liability. |
2,897,007 |
|
— |
|
Total
liabilities |
9,767,138 |
|
6,496,525 |
|
Stockholders’ equity: |
|
|
|
|
Common
stock |
1,114 |
|
1,099 |
|
Additional
paid-in capital |
16,133,905 |
|
15,317,335 |
|
Retained
earnings |
28,515,056 |
|
26,669,491 |
|
Accumulated
other comprehensive loss |
(3,998 |
) |
(42,192 |
) |
Total
stockholders’ equity |
44,646,077 |
|
41,945,733 |
|
Total
liabilities and stockholders’ equity |
$ |
54,413,215 |
|
$ |
48,442,258 |
|
IRADIMED
CORPORATIONCONDENSED STATEMENTS OF
OPERATIONS(Unaudited)
|
Three Months Ended March
31, |
|
|
2019 |
|
2018 |
|
Revenue |
$ |
8,437,593 |
|
$ |
7,108,151 |
|
Cost of revenue |
2,047,827 |
|
1,691,535 |
|
Gross
profit |
6,389,766 |
|
5,416,616 |
|
Operating expenses: |
|
|
|
|
General and
administrative |
2,412,696 |
|
2,303,532 |
|
Sales and
marketing |
2,110,652 |
|
1,645,936 |
|
Research and
development |
352,573 |
|
379,826 |
|
Total
operating expenses |
4,875,921 |
|
4,329,294 |
|
Income from
operations |
1,513,845 |
|
1,087,322 |
|
Other income, net |
92,574 |
|
40,072 |
|
Income
before provision for income taxes |
1,606,419 |
|
1,127,394 |
|
Provision for income tax
(benefit) expense |
(239,146 |
) |
286,198 |
|
Net income |
$ |
1,845,565 |
|
$ |
841,196 |
|
|
|
|
|
|
Net income per share: |
|
|
|
|
Basic |
$ |
0.17 |
|
$ |
0.08 |
|
Diluted |
$ |
0.15 |
|
$ |
0.07 |
|
Weighted average shares
outstanding: |
|
|
|
|
Basic |
11,029,639 |
|
10,608,387 |
|
Diluted |
12,227,696 |
|
11,879,889 |
|
IRADIMED
CORPORATIONCONDENSED STATEMENTS OF CASH
FLOWS(Unaudited)
|
Three Months Ended March 31, |
|
|
2019 |
|
2018 |
|
Operating activities: |
|
|
|
|
Net
income |
$ |
1,845,565 |
|
$ |
841,196 |
|
Adjustments
to reconcile net income to net cash provided by operating
activities: |
|
|
|
|
Change in
allowance for doubtful accounts |
21,450 |
|
8,842 |
|
Change in
provision for excess and obsolete inventory |
120,529 |
|
61,011 |
|
Depreciation
and amortization |
387,081 |
|
427,747 |
|
Stock-based
compensation |
382,353 |
|
416,327 |
|
Deferred
income taxes, net |
59,048 |
|
(123,689 |
) |
Loss (gain)
on maturities of investments |
3,826 |
|
(550 |
) |
Changes in
operating assets and liabilities: |
|
|
|
|
Accounts
receivable |
(1,140,008 |
) |
490,147 |
|
Inventory |
(333,546 |
) |
(155,234 |
) |
Prepaid
expenses and other current assets |
(665,862 |
) |
(254,051 |
) |
Other
assets |
(4,891 |
) |
(18,185 |
) |
Accounts
payable |
375,202 |
|
(80,631 |
) |
Accrued
payroll and benefits |
(378,354 |
) |
(331,790 |
) |
Other
accrued taxes |
(46,832 |
) |
(75,365 |
) |
Warranty
reserve |
(341 |
) |
10,414 |
|
Deferred
revenue |
338,078 |
|
(42,344 |
) |
(Prepaid)
accrued income taxes, net |
(298,094 |
) |
410,045 |
|
Net cash
provided by operating activities |
665,204 |
|
1,583,890 |
|
Investing
activities: |
|
|
|
|
Proceeds
from maturities of investments |
650,000 |
|
250,000 |
|
Purchases of
property and equipment |
(82,943 |
) |
(37,983 |
) |
Capitalized
intangible assets |
(9,724 |
) |
(298 |
) |
Net cash
provided by investing activities |
557,333 |
|
211,719 |
|
Financing
activities: |
|
|
|
|
Proceeds
from exercises of stock options |
456,739 |
|
95,924 |
|
Taxes paid
related to net share settlement of equity awards |
(22,507 |
) |
(4,376 |
) |
Net cash
provided by financing activities |
434,232 |
|
91,548 |
|
Net increase in cash and
cash equivalents |
1,656,769 |
|
1,887,157 |
|
Cash and cash equivalents,
beginning of period |
28,027,688 |
|
18,205,976 |
|
Cash and cash equivalents,
end of period |
$ |
29,684,457 |
|
$ |
20,093,133 |
|
IRADIMED
CORPORATIONRECONCILIATION OF NON-GAAP FINANCIAL
MEASURES (UNAUDITED)
Non-GAAP Net Income and Diluted
EPS
|
Three Months Ended March
31, |
|
|
2019 |
|
|
2018 |
|
Net income |
$ |
1,845,565 |
|
|
$ |
841,196 |
|
Excluding: |
|
|
|
|
Stock-based
compensation expense, net of tax expense |
287,491 |
|
|
313,761 |
|
Infrequent
tax item |
(564,810 |
) |
|
— |
|
Non-GAAP net
income |
$ |
1,568,246 |
|
|
$ |
1,154,957 |
|
Weighted-average shares
outstanding – diluted |
12,227,696 |
|
|
11,879,889 |
|
Non-GAAP net income per
share – diluted |
$ |
0.13 |
|
|
$ |
0.10 |
|
*The infrequent tax item is related to the excess tax benefits
recognized in the provision for income taxes associated with the
exercise and sale of certain incentive stock options.
Free Cash Flow
|
Three Months Ended March
31, |
|
|
2019 |
|
2018 |
|
Net cash provided by
operating activities. |
$ |
665,204 |
|
$ |
1,583,890 |
|
Less: |
|
|
|
|
Purchases of
property and equipment |
82,943 |
|
37,983 |
|
Free cash
flow |
$ |
582,261 |
|
$ |
1,545,907 |
|
Media Contact:Chris ScottChief Financial OfficeriRadimed
Corporation(407) 677-8022 InvestorRelations@iradimed.com
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