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| Press Release November 4, 2004 | |
LAKE FOREST, Calif.--(BUSINESS WIRE)--Nov. 4, 2004--
Nine-Month Revenue Increased 50% to a Record $50 Million On 102%
Increase in Regional Anesthesia Sales; Oncology Infusion Services
Third Quarter Revenue Increased 59% to A Record $5.2 Million
I-FLOW CORPORATION (NASDAQ:IFLO) announced today that revenue for the third quarter of 2004 increased 58% to a record $18,688,000, compared to $11,822,000 for the third quarter of 2003, reflecting a 117% increase in Regional Anesthesia sales and continued growth in revenue for the Company's Oncology Infusion Services and Infusion Therapy segments. Revenue for the first nine months of 2004 increased 50% to a record $50,024,000 from $33,340,000 for the first nine months of 2003 on the strength of a 102% increase in Regional Anesthesia sales. "Our focus on increasing awareness and driving adoption of our proprietary ON-Q(R) family of products for narcotic-free relief of post-surgical pain is delivering the growth we anticipated," said Chairman, President and Chief Executive Officer Donald M. Earhart. Third Quarter Results For the three months ended September 30, 2004, net revenue increased to a record $18,688,000 from $11,822,000 for the third quarter of 2003. Gross profit improved to 71% of revenue for this year's third quarter, compared to 64% for the same period last year. The net loss for this year's third quarter was $1,770,000, or $0.08 per share. This compares to a net loss for the third quarter of 2003 of $386,000, or $0.02 per share. Nine Month Results For the nine months ended September 30, 2004, net revenue increased 50% to a record $50,024,000, compared to net revenue of $33,340,000 for the first nine months of 2003. Gross profit rose to 69% of revenue for the first nine months of 2004, compared to 65% for the same period last year. The net loss for this year's first nine months was $4,774,000, or $0.24 per share, compared to a net loss for the first nine months of 2003 of $347,000, or $0.02 per share. Strategic Highlights "Each year, millions of surgical patients potentially could benefit from our ON-Q technology in the United States alone. This is a tremendous opportunity for sustained growth. Our goal is to establish our ON-Q brand as the new 'best practice' in post-surgical pain relief, and, ultimately, to replace narcotics as the standard of care. Our four-pronged strategy of building our direct sales force, supporting independent third-party clinical studies that demonstrate the benefits of ON-Q in an expanding number of surgical applications, offering innovative programs to facilitate reimbursement and reduce reimbursement risk, and promoting ON-Q with carefully targeted marketing campaigns is moving us steadily toward our objective," Earhart said.
Recent highlights include:
-- Further expansion of the Company's distribution capabilities,
with ON-Q now available in more than 900 hospitals and
ambulatory surgery centers (ASC's) throughout the United
States. At the end of the third quarter, I-Flow's
hospital-focused direct sales force numbered 106
quota-carrying sales professionals calling on hospitals and
surgeons, compared to 60 at the end of last year and 87 at the
end of the second quarter of 2004. Since its launch just a few
months ago, I-Flow's other ON-Q sales force targeted
exclusively at ASC's and other outpatient settings already
numbers 20 sales professionals.
-- The receipt of CE Mark approval for I-Flow's ON-Q brand for
additional indications for use within the European Union.
"These additional indications are identical to the FDA
clearance that ON-Q received in May 2004, and allow I-Flow to
market ON-Q as superior to narcotics alone for reducing pain
after surgery. Now, all ON-Q branded products sold within the
United States, Canada, and the European Union's 25 member
states are cleared to carry this enhanced labeling. We believe
that this will dramatically enhance our ability to market ON-Q
in Europe, and will facilitate the development of a
distributor network for this large market," Earhart explained.
-- An agreement to make ON-Q available to health care
organizations that purchase supplies through Novation LLC, the
supply company of VHA Inc. and University HealthSystem
Consortium that serves more than 2,300 health care
organizations nationwide, including 1,400 acute care
facilities. Also, the award of a contract by MedAssets, a
fast-growing group purchasing organization and supply chain
management company, under which MedAssets will offer ON-Q to
its network of healthcare providers, including hospitals and
ASC's. "We now have established relationships with four of the
largest group purchasing organizations in the United States.
This is a major accomplishment for I-Flow that demonstrates
how far we have come in increasing acceptance for our ON-Q
products, and demonstrating ON-Q's value in enhancing patient
care. These contracts open the doors for our direct sales
force to make the benefits of ON-Q available to a
significantly expanded target market," Earhart said.
-- The publication of a study of abdominal surgery that found
that continuous post-surgical wound infiltration with a local
anesthetic delivered by ON-Q increased tissue oxygenation at
the surgical site, which may enhance wound healing and prevent
post-operative wound infections. Another study following
gynecologic oncology surgery also supported the use of ON-Q to
provide pain relief after surgery without increasing the risk
of wound infections. "These are compelling results that
support our belief that the use of ON-Q helps increase
oxygenation, which promotes faster wound healing, and does not
cause an increase in surgical-site complications such as
infection," Earhart said.
-- Other recently published studies demonstrated the
effectiveness of ON-Q in treating pain while minimizing the
use of narcotics in additional surgical procedures, including
outpatient bariatric (weight loss) surgery, outpatient total
hip replacement surgery, and radical prostatectomy surgery
performed with a robotic, minimally invasive technique. "In
trial after trial, and in indication after indication, the
clinical results have been remarkably consistent -- ON-Q helps
surgical patients recover faster, with less pain and less
narcotics use," Earhart said.
Regional Anesthesia
Sales in I-Flow's Regional Anesthesia market segment, which includes the ON-Q(R) PainBuster(R) Post-Operative Pain Relief System, the ON-Q(R) C-bloc(R) Continuous Nerve Block System and the Soaker(TM) Catheter, increased 117% to $8,735,000 for this year's third quarter, compared to $4,032,000 for the same period a year ago. Excluding sales in the prior year quarter to the Company's former distributor dj Orthopedics, the increase in U.S. ON-Q sales was 138%. For the first nine months of 2004, Regional Anesthesia sales increased 102% to $21,969,000 from $10,886,000 for the first nine months of 2003. Oncology Infusion Services Third quarter revenue for I-Flow's InfuSystem subsidiary increased 59% to $5,212,000, compared to $3,275,000 for the third quarter of 2003. For the first nine months of 2004, sales increased 45% to $13,951,000 from $9,619,000 for the same period of 2003. Earhart noted that, "With the emergence of additional protocols requiring the use of electronic ambulatory infusion pumps, we believe there are excellent opportunities for further growth in this business." Infusion Therapy Sales of IV Infusion Therapy products, which include the Company's intravenous elastomeric pumps, mechanical infusion devices and disposables, and recently discontinued electronic infusion pumps, increased 5% to $4,741,000 for the third quarter of 2004 versus $4,515,000 for the same period last year. For the first nine months of 2004, IV Infusion Therapy sales increased 10% to $14,104,000 versus $12,835,000 a year ago. Balance Sheet At September 30, 2004, I-Flow reported net working capital of $66 million, including cash and equivalents of $46.4 million, no long-term debt, and shareholders' equity of $87.1 million. On April 19, 2004, I-Flow announced the completion of its public offering of 2,990,000 shares of common stock, including the underwriters' over-allotment option, for net proceeds to the Company of $43.1 million. Conference Call I-Flow has scheduled a conference call today at 11:00 a.m. ET. A simultaneous webcast may be accessed from the Investors' "Event Calendar" link at www.IFLO.com. A replay will be available after 1:00 p.m. ET at the same Internet address. For a telephone replay, dial 800-633-8284, reservation #21210715, after 1:00 p.m. ET. About I-Flow I-Flow Corporation (www.IFLO.com) designs, develops and markets technically advanced, low cost ambulatory infusion systems that are redefining the standard of care by providing life enhancing, cost effective solutions for pain relief. "Safe Harbor" Statement Certain disclosures made by the Company in this press release and in other reports and statements released by the Company are and will be forward-looking in nature, such as comments that express the Company's opinions about trends and factors that may impact future operating results. Disclosures that use words such as the Company "believes," "anticipates," or "expects" or use similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ from those expected, and readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to republish revised forward-looking statements to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures made by the Company in this release which seek to advise interested parties of the risks and other factors that affect the Company's business, as well as in the Company's periodic reports on Forms 10-K, 10-Q and 8-K filed with the Securities and Exchange Commission. The risks affecting the Company's business include, among others: implementation of our direct sales strategy; dependence on our suppliers and distributors; reliance on the success of the home health care industry; our continuing compliance with applicable laws and regulations, such as the Food, Drug and Cosmetic Act, and the FDA's concurrence with our management's subjective judgment on compliance issues; the reimbursement system currently in place and future changes to that system; competition in the industry; economic and political conditions in foreign countries; currency exchange rates; inadequacy of booked reserves; technological changes; and product availability and acceptance. All forward-looking statements, whether made in this release or elsewhere, should be considered in context with the various disclosures made by the Company about its business.
I-FLOW CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
($ in thousands, except for per share data)(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------- -------------------
2004 2003 2004 2003
--------- --------- --------- ---------
Net Revenues $18,688 $11,822 $50,024 $33,340
Cost of sales 5,377 4,312 15,280 11,799
--------- --------- --------- ---------
Gross Profit 13,311 7,510 34,744 21,541
Costs and expenses:
Selling, general &
administrative 15,564 7,730 40,627 20,916
Product Development 743 589 2,013 1,611
--------- --------- --------- ---------
Total expenses 16,307 8,319 42,640 22,527
--------- --------- --------- ---------
Operating loss (2,996) (809) (7,896) (986)
Interest expense (income), net (182) 41 (292) 38
--------- --------- --------- ---------
Loss from continuing
operations before income
taxes (2,814) (850) (7,604) (1,024)
Provision for income taxes
(benefit) (1,044) (343) (2,830) (417)
--------- --------- --------- ---------
Loss from continuing
operations (1,770) (507) (4,774) (607)
Income from discontinued
operations, net of tax -- 121 -- 260
--------- --------- --------- ---------
Net income (loss) $(1,770) $(386) $(4,774) $(347)
--------- --------- --------- ---------
Net income (loss) per share
from continuing operations
Basic and Diluted $(0.08) $(0.03) $(0.24) $(0.04)
Net income (loss) per share
Basic and Diluted $(0.08) $(0.02) $(0.24) $(0.02)
--------- --------- --------- ---------
Weighted average shares
Basic and Diluted 21,501 16,445 20,185 15,827
========= ========= ========= =========
CONDENSED CONSOLIDATED BALANCE SHEET
($ in thousands)(Unaudited)
----------------------------------------------------------------------
ASSETS Sep. 30, Dec. 31, LIABILITIES & Sep. 30, Dec. 31,
2004 2003 EQUITY 2004 2003
----------------------------------------------------------------------
Cash & Equivalents Current
$46,400 $15,185 Liabilities $7,215 $7,123
Other Current
Assets 26,831 23,405
Property, Plant & Long-term
Equipment, Net 10,250 6,744 Liabilities -- --
Shareholders'
Other Assets 10,883 6,562 Equity 87,149 44,773
-------- -------- -------- --------
Total $94,364 $51,896 Total $94,364 $51,896
======== ======== ======== ========
CONTACT: I-Flow Corporation
James R. Talevich, 949-206-2700
www.iflo.com
or
Berkman Associates
Neil Berkman, 310-277-5162
info@BerkmanAssociates.com
SOURCE: I-Flow Corporation
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