Somanetics Reports Net Income of $0.03 Per Share on 37 Percent Net Revenue Growth for the First Quarter of 2004; Company Plans to Double Direct Sales Force.Business Editors/Health/Medical Writers TROY, Mich.--(BUSINESS WIRE)--March 16, 2004 (Nasdaq:SMTS SMTS Space and Missile Tracking System SMTS Senior Member of Technical Staff SMTS Saskatchewan Mathematics Teachers' Society (Canada) SMTS So Much to Say (Dave Matthews Band song) ) Highlights -- Net income increased to $0.03 per diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share. -- Net revenues climbed 37 percent to $2.7 million. -- Cerebral oximetry oximetry /ox·im·e·try/ (ok-sim´e-tre) determination of the oxygen saturation of arterial blood using an oximeter. oximetry (oksim´itrē), n product sales grew 42 percent. -- Gross margins improved to 81 percent. -- Positive cash flow was $287,895. Somanetics Corporation (Nasdaq:SMTS) reported net revenues of $2,670,265 for the first quarter ended February 29, 2004, a 37 percent increase from $1,950,946 in the same period of 2003. Net revenues in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. increased 38 percent to $2,283,396 from $1,651,798 in the same period last year. International net revenues increased 29 percent to $386,869 from $299,148. Net revenues generated by the INVOS(R) Cerebral Oximeter oximeter /ox·im·e·ter/ (ok-sim´e-ter) a photoelectric device for determining the oxygen saturation of the blood. ox·im·e·ter n. Pulse oximeter. and disposable SomaSensor(R) increased 42 percent to $2,463,765, from $1,729,196 in the first quarter of 2003. CorRestore(R) System net revenues were $206,500, a 7 percent decrease from net revenues of $221,750. Somanetics reported first quarter net income of $292,744, or $0.03 per basic and diluted common share, compared with a net loss of $195,450, or $0.02 per basic and diluted common share in the same period of 2003. Cash flow for the quarter was $287,895. Gross margins improved to 81 percent in the first quarter from 77 percent in the 2003 first quarter. "Several catalysts have benefited our INVOS Cerebral Oximeter business in recent months, strengthening the selling environment for our products and positioning our technology as important for improving patient outcomes in cardiac surgery Cardiac surgery is surgery on the heart and/or great vessels performed by a cardiac surgeon. Frequently, it is done to treat complications of ischemic heart disease (for example, coronary artery bypass grafting), correct congenital heart disease, or treat valvular heart disease ," said Bruce Barrett, Somanetics' president and chief executive officer. Recent key events include: -- A northeast regional cardiac surgery society launched a quality improvement initiative including draft guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. recommending routine use of cerebral oximetry in all cardiac surgeries as a best practice strategy to mitigate the occurrence of stroke. This group's approach to stroke mitigation is being widely circulated. -- Results of the first prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. study using the INVOS Cerebral Oximeter during cardiac surgery, presented in mid-2003, support one of Somanetics' key value propositions: managing regional brain oxygen saturation oxygen saturation sO2 The O2 concentration of blood expressed as a ratio of its total O2-carrying capacity; the OS is a measure of the utilization of O2 transport capacity; sO2 levels with the Cerebral Oximeter can significantly reduce a cardiac surgery patient's length of stay. These results are having a noticeable impact on the willingness of clinicians to consider the adoption of cerebral oximetry in their practice. -- Findings from a 2,279-patient study showed a statistically significant reduction in the incidence of permanent stroke, time to extubation and length of hospital stay for cardiac surgery patients monitored with the INVOS System. These results were achieved despite the fact that the group treated using cerebral oximetry had significantly higher co-morbidities and risk factors and were generally sicker overall. Results were presented last week at the Cardiothoracic cardiothoracic /car·dio·tho·rac·ic/ (-thah-ras´ik) pertaining to the heart and the thorax. car·di·o·tho·rac·ic n. Of or relating to the heart and the chest. Techniques and Technologies annual meeting by Scott Goldman, M.D. Dr. Goldman is chairman of the department of surgery at Pennsylvania-based Lankenau Hospital Lankenau Hospital is a 351-bed tertiary care, community based teaching hospital located in Wynnewood, Pennsylvania. Lankenau was founded in 1860 as the German Hospital of Philadelphia, and located in North Philadelphia on Morris Street. , a member of the Main Line Health hospital system. While various clinical studies using the INVOS Cerebral Oximeter to monitor cardiac surgery patients have shown evidence of reduced occurrence of stroke, this is the first study with a large enough number of patients to show a statistically significant reduction in permanent stroke in cardiac surgery. -- Somanetics and Fresenius Medical Care Fresenius Medical Care is a German company specializing in the production of medical supplies, primarily to facilitate or aid renal dialysis. It is 37%-owned by the health care company Fresenius SE. Extracorporeal extracorporeal /ex·tra·cor·po·re·al/ (-kor-por´e-al) situated or occurring outside the body. ex·tra·cor·po·re·al adj. Situated or occurring outside the body. Alliance (FMCEA FMCEA Failure Mode Cause & Effect Analysis ), a division of Fresenius Medical Care North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. , have initiated a business relationship where FMCEA will provide the INVOS technology to its cardiovascular perfusion perfusion /per·fu·sion/ (-zhun) 1. the act of pouring over or through, especially the passage of a fluid through the vessels of a specific organ. 2. a liquid poured over or through an organ or tissue. customers. FMCEA provides extracorporeal therapies to 450 hospitals nationwide, including 170 open heart surgery programs. FMCEA is the leading provider of contract perfusion services in the U.S., performing approximately 50,000 cardiac procedures. The business relationship is designed to utilize the combination of Somanetics' technology and the expertise of the FMCEA clinical staff to facilitate the utilization of the INVOS technology and to educate cardiac surgery clinicians and hospital administrators about the importance of monitoring cerebral oxygen levels during open heart surgery. INVOS Cerebral Oximeter Sales Initiatives "These events reflect the emerging market opportunities for cerebral oximetry, and Somanetics is positioning itself to capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. them through a more aggressive sales strategy," Barrett said. "In certain sales territories where we have optimized our distribution by placing direct representatives and/or cardiac surgery-focused independent representatives, we experienced more than 40 percent SomaSensor unit growth and more than 100 percent revenue growth year-over-year in the first quarter. Our goal is to replicate rep·li·cate v. 1. To duplicate, copy, reproduce, or repeat. 2. To reproduce or make an exact copy or copies of genetic material, a cell, or an organism. n. A repetition of an experiment or a procedure. the formula that has proved successful in these territories by bolstering our resources in more geographies. As part of our sales effort, we intend to double the size of our direct sales team by mid year." In the second quarter of 2004 Somanetics expects to incur a charge of approximately $80,000 related to the termination of some of its independent sales representative firms. CorRestore Education Initiatives As the data continues to emerge establishing Surgical Ventricular ven·tric·u·lar adj. Of or relating to a ventricle or ventriculus. ventricular pertaining to a ventricle. ventricular assist device Restoration, or SVR Noun 1. SVR - Russia's intelligence service responsible for foreign operations, intelligence-gathering and analysis, and the exchange of intelligence information; collaborates with other countries to oppose proliferation of weapons of mass destruction, terrorism and , as an effective alternative for certain patients with severe congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. (CHF CHF In currencies, this is the abbreviation for the Swiss Franc. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ), Somanetics remains focused on educating primary care givers to identify and refer appropriate candidates and training surgeons to perform SVR with the CorRestore System. The RESTORE Group presented its results at the annual meeting of the Society for Thoracic thoracic /tho·rac·ic/ (thah-ras´ik) pectoral; pertaining to the thorax (chest). tho·rac·ic adj. Of, relating to, or situated in or near the thorax. Surgeons. This international group of cardiac surgeons A cardiac surgeon is a surgeon who performs cardiac surgery - operative procedures on the heart and great vessels. Training In the United States and Canada, a cardiac surgery residency typically comprises anywhere from six to nine years (or longer) of training to become and cardiologists from 13 centers conducted a review of 1,198 patients who underwent the SVR operation for severe CHF. A low hospital mortality (five percent) was observed among these critically ill patients. Readmission readmission Managed care The admission of a Pt to a health care facility for a condition–eg, stroke, MI, GI bleeding, hip fracture, cancer surgery, shortly after discharge. See nth admission. Cf Admission, Discharge. to the hospital for heart failure symptoms, a frequent occurrence among CHF patients, was low (22 percent at five years). Overall five-year survival five-year survival Epidemiology The timespan that a person survives with a particular dread disease, in particular CA; 5YS facilitates standardization of survival statistics. See Cancer-free survival. was 69 percent. Patients who were symptomatic with minimal activity (NYHA NYHA New York Heart Association Class III) had a five-year survival of 70 percent and those with symptoms at rest (NYHA Class IV) had a five-year survival rate of 50 percent. By contrast, conventional treatments among Class IV patients yields a poor prognosis prognosis /prog·no·sis/ (prog-no´sis) a forecast of the probable course and outcome of a disorder.prognos´tic prog·no·sis n. pl. prog·no·ses 1. with only 10 to 20 percent survival at five years. Business Outlook "We are encouraged by the strong first quarter performance of our INVOS Cerebral Oximeter products, the new data presented by Dr. Goldman and by the initial success of our pilot program with Fresenius," Barrett said. "Based on the business trends we are seeing in our target markets, we are on track to achieve our previously announced fiscal 2004 guidance of earnings per share in the range of $0.12 to $0.15 per basic share on net revenue growth of 30 percent to 40 percent." Somanetics to Host Conference Call Somanetics will webcast its first quarter conference call at 11:00 (ET) today. During the webcast, Mr. Barrett, and Bill Iacona, vice president, finance, will review corporate highlights and summarize sum·ma·rize intr. & tr.v. sum·ma·rized, sum·ma·riz·ing, sum·ma·riz·es To make a summary or make a summary of. sum Somanetics' first quarter financial results. To listen to the webcast, visit the Investor Center section of Somanetics' website at www.somanetics.com at least 15 minutes prior to the event's broadcast and click on the "First Quarter Conference Call" link. Interested parties unable to listen to the live call may access the archived version of the call on the Investor Center section of Somanetics' website. About Somanetics Somanetics develops and markets two medical devices focused on the cardiac surgery market that offer solutions to help meet critical medical needs. The INVOS Cerebral Oximeter is the only noninvasive non·in·va·sive adj. 1. Not penetrating the body, as by incision. Used especially of a diagnostic procedure. 2. Not invading healthy tissue. and continuous monitor of changes in regional brain blood oxygen saturation that is commercially available in the U.S. Use of the INVOS Cerebral Oximeter helps medical professionals, such as surgeons and anesthesiologists, identify regional brain blood oxygen imbalances and take corrective action A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or . Such action can prevent or reduce neurological neurological, neurologic pertaining to or emanating from the nervous system or from neurology. neurological assessment evaluation of the health status of a patient with a nervous system disorder or dysfunction. injuries related to adverse events during surgery or in the critical care unit and reduce the associated cost of care. The CorRestore System is a cardiac implant implant /im·plant/ (im-plant´) to insert or to graft (tissue, or inert or radioactive material) into intact tissues or a body cavity. for use in cardiac repair and reconstruction, including an operation called Surgical Ventricular Restoration, SVR, a treatment for patients with certain types of severe congestive heart failure. Somanetics' web site is www.somanetics.com. Safe-Harbor Statement Except for historical information contained herein, the matters discussed in this news release are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , the accuracy of which is necessarily subject to risks and uncertainties. Actual results may differ significantly from results discussed in the forward-looking statements. Actual results may be affected by, among other things, economic conditions in general and in the healthcare market, new product development cycles, research and development activities, regulatory approvals of new products, the demand for and market for our products in domestic and international markets, introduction of competitive products by others, third party reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. , physician training, enforceability and the costs of enforcement of the Company's patents, potential infringements and other factors set forth from time to time in Somanetics' Securities and Exchange Commission filings, including Somanetics' Registration Statement on Form S-1 (file no. 333-74788) effective January 11, 2002. (Tables to follow)
SOMANETICS CORPORATION
STATEMENTS OF OPERATIONS
(Unaudited)
For the Three-Month
Periods Ended
---------------------------
February 29, February 28,
2004 2003
------------ ------------
NET REVENUES $ 2,670,265 $ 1,950,946
COST OF SALES 520,393 450,197
------------ ------------
GROSS MARGIN 2,149,872 1,500,749
------------ ------------
OPERATING EXPENSES:
Research, development and engineering 87,690 109,173
Selling, general and administrative 1,774,900 1,594,930
------------ ------------
Total operating expenses 1,862,590 1,704,103
------------ ------------
OPERATING INCOME (LOSS) 287,282 (203,354)
------------ ------------
OTHER INCOME:
Interest income 5,462 7,904
------------ ------------
Total other income 5,462 7,904
------------ ------------
NET INCOME (LOSS) $ 292,744 $ (195,450)
------------ ------------
NET INCOME (LOSS) PER COMMON
SHARE - BASIC AND DILUTED $ .03 $ (.02)
------------ ------------
WEIGHTED AVERAGE SHARES
OUTSTANDING - BASIC 9,308,607 9,077,891
============ ============
WEIGHTED AVERAGE SHARES
OUTSTANDING - DILUTED 11,296,295 9,077,891
============ ============
SOMANETICS CORPORATION
BALANCE SHEETS
February 29, November 30,
2004 2003
------------ ------------
(Unaudited) (Audited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 2,527,087 $ 2,239,192
Accounts receivable 1,640,627 2,018,615
Inventory 1,010,341 1,090,261
Prepaid expenses 172,742 123,203
------------ ------------
Total current assets 5,350,797 5,471,271
------------ ------------
PROPERTY AND EQUIPMENT (at cost):
Machinery and equipment 2,192,197 2,071,758
Furniture and fixtures 239,524 248,657
Leasehold improvements 171,882 171,882
------------ ------------
Total 2,603,603 2,492,297
Less accumulated depreciation
and amortization (1,785,973) (1,782,559)
------------ ------------
Net property and equipment 817,630 709,738
------------ ------------
OTHER ASSETS:
Intangible assets, net 958,110 959,838
Other 15,000 15,000
------------ ------------
Total other assets 973,110 974,838
------------ ------------
TOTAL ASSETS $ 7,141,537 $ 7,155,847
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 377,105 $ 641,232
Accrued liabilities 238,791 349,547
------------ ------------
Total current liabilities 615,896 990,779
------------ ------------
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Preferred shares; authorized,
1,000,000 shares of $.01 par value;
no shares issued or outstanding -- --
Common shares; authorized,
20,000,000 shares of $.01 par value;
issued and outstanding,
9,313,680 shares at February 29, 2004,
and 9,298,669 shares at
November 30, 2003 93,137 92,987
Additional paid-in capital 59,728,482 59,660,804
Accumulated deficit (53,295,978) (53,588,723)
------------ ------------
Total shareholders' equity 6,525,641 6,165,068
------------ ------------
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY $ 7,141,537 $ 7,155,847
============ ============
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