Misonix Reports First Quarter Results for the Period Ended September 30, 2006.FARMINGDALE, N.Y. -- Misonix, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : MSON MSON Multi-Service Optical Networking (SBC) MSON Medium Speed on ), a developer of ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, today reported fiscal results for the three months ended September 30, 2006. Highlights of the first quarter of fiscal 2007 and other Company initiatives to date include: * First quarter 2007 revenues increase year-over-year and sequentially * Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. reduced by over 7% from year-ago quarter and over 13% from fourth quarter of fiscal 2006 * Top line improvement and expense management drive significant reduction in net loss * Commercially launched the Ultrasonic Wound Care Systems/Sonic One with Medline * Established Distribution of the Sonablate[R] 500 ("SB500") using HIFU HIFU High-intensity focused ultrasound Surgery A method that focuses ultrasound to heat/ablate target tissue without injuring surrounding structures. See Sonablate 200™. for prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. in 10 countries throughout Europe * Increasing market share of fee-per-use sites and procedures * Continued 5 site clinical studies with SB500 * Received 510(k) for Bone Shaver product for neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. * Successful laparoscopic Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies HIFU kidney cancer Kidney Cancer Definition Kidney cancer is a disease in which the cells in certain tissues of the kidney start to grow uncontrollably and form tumors. clinicals * Distributor selection process commenced for Osteotome osteotome /os·teo·tome/ (os´te-o-tom?) a chisel-like knife for cutting bone. os·te·o·tome n. A chisel-like instrument for cutting bone. "Bone Cutter Types of medical bone cutters include: Unpowered Unpowered bone cutting implements include the variety of hacksaw and Sabre saw. In many applications, the saw is used in specialised jigs to provide accurate, measurable cuts, eg Knee Surgery. " * Commercially launched new compliant Labcaire Endoscopic en·do·scope n. An instrument for examining visually the interior of a bodily canal or a hollow organ such as the colon, bladder, or stomach. en Disinfectant disinfectant, agent that destroys disease-causing microorganisms and their spores. Disinfectants, or germicides, are sometimes considered to be substances applied to inanimate bodies, whereas antiseptics, not so potent, are agents that kill microbes on living things. Unit, "ISIS" Revenues for the three months ended September 30, 2006 were $9.6 million, a 6% increase when compared to revenues of $9.1 million for the same period in fiscal 2006. The Company recorded a net loss for the first fiscal quarter 2007 of ($542,000) or ($.08) loss per fully diluted share, compared to a net loss of ($1.3) million or ($.19) loss per fully diluted share, for the same period in fiscal 2006. Medical device product revenues decreased 3% to $4.8 million and laboratory and scientific product revenues increased 16% to $4.8 million. The decrease in medical device product revenues was attributable to a 12% reduction in diagnostic medical device revenues, partially offset by the increase in therapeutic medical device revenues, primarily the result of increased fee-per-use revenues from Sonablate 500 procedures in Europe. The increase in laboratory and scientific product revenues was primarily due to additional product sales of the Labcaire Guardian endoscopic disinfectant systems and service revenue. The backlog of unfilled orders as of September 30, 2006 was $8.2 million, including medical device product backlog of $5.6 million and laboratory and scientific product backlog of $2.6 million. Commenting on the Company's financial results and recent developments, Michael A. McManus Jr., President and Chief Executive Officer, said, "The improved performance for Misonix in the first quarter of fiscal 2007 reflects our solid execution on several fronts. Among our achievements in the quarter was the return of top line growth. With the first sales by Medline of our new Ultrasonic Wound Care System we are very encouraged and view this product as just one new medical device that we will launch in fiscal 2007. As our new products receive industry recognition supporting the many benefits of ultrasound technology and the exceptional development and manufacturing capabilities of Misonix, we look for continued contribution to our base of revenues with continued traction in very large and important healthcare markets. In the U.S. alone there are more than 4.5 million annual cases of hospitalization hospitalization /hos·pi·tal·iza·tion/ (hos?pi-t'l-i-za´shun) 1. the placing of a patient in a hospital for treatment. 2. the term of confinement in a hospital. because of chronic wounds. "While increasing our revenues in the first quarter, concerted efforts were made to contain costs and maximize our cash flow. To this end, we are pleased to have increased our gross profit margin Gross profit margin Gross profit divided by sales, which is equal to each sales dollar left over after paying for the cost of goods sold. gross profit margin A measure calculated by dividing gross profit by net sales. by over 14% from the prior year period and by 30% from the fourth quarter of fiscal 2006. Meanwhile, we reduced our total operating expenses by over 7% from the year-ago quarter and by over 13% as compared to the fourth quarter of fiscal 2006. The higher revenues and improved margin along with careful management of our spending enabled the Company to reduce the quarterly operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. by 50% as compared to the first quarter 2006 and sequentially by 65%. "Cash management and expense controls will remain an integral component of our plan. However, the overall progress achieved in the first quarter reflects the execution of our five-pronged strategy for fiscal 2007. We made considerable progress year to date in executing this strategy. The five elements five elements, n.pl fire, water, earth, wood, and metal; in Chinese medicine, each of these five components is used to organize phenomena for use in clinical applications. Each of the elements corresponds to a specific function (i.e. of the strategy include: 1) Continued progress in marketing the SB500 for high intensity focused ultrasound HIFU (high intensity focused ultrasound) (sometimes FUS or HIFUS) is a highly precise medical procedure using high-intensity focused ultrasound to heat and destroy pathogenic tissue rapidly. ("HIFU") treatment of prostate cancer in Europe; 2) Completion of clinicals and other regulatory/development efforts that leverage our HIFU technology for the treatment of kidney cancer; 3) Supporting Medline and related initiatives in the marketing and sales of the SonicOne medical device; 4) Completion of clinicals and selection of a distributor for the launch of our Bone Cutter medical device; and 5) Introduction of the Bone Shaver. "On the SB500 for HIFU treatment of prostate cancer, we continue to make significant progress. At the end of the quarter, we had distributors in place in 10 countries. We now have 49 sites, 17 certified physicians, 32 physicians in training and approximately 320 patients treated in the first nine months of calendar 2006 as compared to 269 for the entire year in 2005. Importantly, we are moving closer to completing a five site clinical trial in Europe for which the results to date have been encouraging and show a favorable comparison to other HIFU procedures in terms of higher success rates in the treatment of cancer and the reduction in PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. levels. Patient outcomes at all of our trial sites using the SB500 show lower incidences of impotence and incontinence than other HIFU treatments. This fiscal year we expect to sign new distributors and to increase the number of units sold and patients treated on our fee-per-use model. The message is loud and clear that after only 2 years we are gaining momentum in the medical community as the HIFU product of choice for prostate cancer treatment. Although later to market, we believe the SB500 is making up market share using visually directed HIFU as compared to an estimated energy exposure, an algorithm based approach. The SB500 does not require an invasive procedure Invasive procedure may refer to:
"Focus Surgery continues to make progress on the clinical program required for FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for the use of HIFU for the treatment of prostate cancer in the U.S. Necessary financial support is being provided by USHIFU which also continues to grow market share. Together with Focus Surgery, we will be making progress in the U.S. on both prostate and kidney cancer. "By leveraging our HIFU technology, we had previously announced our intent to develop a product for the treatment of kidney cancer. An initial 510(k) clearance from the U.S. Food and Drug Administration was received for laparoscopic HIFU using our newly developed medical device, the Sonatherm 600. We have now completed a variety of clinicals on the kidney both in the U.S. and internationally and will use this data along with product modifications for the submission of an addendum addendum n. an addition to a completed written document. Most commonly this is a proposed change or explanation (such as a list of goods to be included) in a contract, or some point that has been subject of negotiation after the contract was originally proposed by to our 510(k) that will allow us to market the product specifically for treatment of kidney cancer. Kidney cancer is a global market of approximately $100 million, with the majority of this market residing outside of the U.S. We remind you we are the only Company in the world that has a product using minimally invasive HIFU for kidney cancer. We expect to begin work on the treatment of live cancer in the near future. It is important to note that we are not just a one product company. "Another exciting new entrant for Misonix is the SonicOne Ultrasonic Wound Care System. The SonicOne establishes a new standard in chronic wound care and ensures the best healing trajectory possible, which assists in minimizing health care costs. As previously announced, we entered into a U.S. distribution agreement with Medline. Medline has commenced sales of the product and also is very active in marketing initiatives intended to accelerate market adoption of this unique device. They are supporting the product through advertising in trade publications as well as in conference appearances. Targeting the $3 billion wound care market with the near epidemic concerns of diabetes as a catalyst, Medline is proving to be an excellent partner. Studies have also shown that the use of ultrasonic debridement Debridement Definition Debridement is the process of removing nonliving tissue from pressure ulcers, burns, and other wounds. Purpose Debridement speeds the healing of pressure ulcers, burns, and other wounds. provides an additional benefit of bioburden eradication to promote faster healing of tissue. "Among other products in our diverse pipeline, our new OsteoSculpt bone shaver, which will be used to accelerate sales of our neuroaspirator, has recently received 510(k) clearance from the U.S. Food and Drug Administration. The bone shaver is a consumable A material that is used up and needs continuous replenishment, such as paper and toner. "The low-tech end of the high-tech field!" product that can only be used once per treatment, therefore delivering a recurring revenue stream. We expect to launch this product domestically through our current distributor Aesculap in the first quarter of calendar 2007. The ultrasonic Osteotome or "bone cutter" has been used successfully in a variety of clinicals and is expected to be launched following the selection of a distributor in the middle of calendar 2007. This product will be introduced into the estimated $100 million global laminectomy laminectomy /lam·i·nec·to·my/ (lam?i-nek´tah-me) excision of the posterior arch of a vertebra. lam·i·nec·to·my n. Excision of a vertebral lamina. Also called rachiotomy. market. There are more than 240,000 cases of laminectomies in the U.S. each year. "Delivering on the five-pronged strategy for fiscal 2007 will firmly position Misonix with the most powerful ultrasonic medical device platform in the world. Our current strategy is intended to place Misonix on a trajectory for years of revenue growth due to the large market sizes and importance of the many products in our medical device pipeline. With the substantial investments in research and development for many of these products and higher than normal spending to create a supportive sales and marketing infrastructure of the past few years, we are very encouraged by our progress in the first quarter and the opportunities ahead of the Company for the balance of fiscal 2007 and beyond. "Your Company has the largest platform of ultrasonic medical devices that I am aware of and each of them has substantial near term potential. We expect 100% growth in the number of fee-per-use procedures using the SB500 for prostate cancer. Together with Focus Surgery we will move forward to complete clinicals in the U.S. for FDA approval for the treatment of prostate cancer. While these accomplishments are substantial, we will also compete and begin to see products using ultrasound in very large markets for wound care, bone shaving, bone cutting and HIFU for kidney and liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. . All of these products will be sold by Misonix throughout the world." As previously announced, the Company has scheduled a conference call and web cast to discuss its first quarter fiscal year 2007 financial results today, November 14, 2006, at 4:30 PM Eastern time. The conference call will be broadcast live on the Internet via the Investor Relations Investor relations The process by which the corporation communicates with its investors. section of the Company's Web site at www.misonix.com. Alternatively, participants may join the conference call by dialing 866-202-0886 (domestic) or 617-213-8841 (international) and entering the reservation code 75645092. Participants should use these access methods about 10 minutes prior to the start time. For those unable to attend the live broadcasts, replays will be available beginning approximately one hour after the events. Replay information will be posted on the Misonix Web site following the conclusion of the live broadcasts. There is no charge for participants to access the live broadcasts or replays. About Misonix: Misonix, Inc. (NASDAQ: MSON) designs, develops, manufactures, and markets medical, scientific, and industrial ultrasonic equipment, laboratory safety equipment, and air pollution control products. Misonix's ultrasonic platform is the basis for several innovative medical technologies. Misonix has a minority equity position in Focus Surgery, Inc. which uses high intensity focused ultrasound technology to destroy deep-seated cancerous tissues without affecting surrounding healthy tissue. Addressing a combined market estimated to be in excess of $3 billion annually, Misonix's proprietary ultrasonic medical devices are used for wound debridement, cosmetic surgery cosmetic surgery, plastic surgery for cosmetic purposes, such as the improvement of the appearance of the face by removing wrinkles or reshaping the nose. , neurosurgery, laparoscopic surgery laparoscopic surgery: see endoscope. , and other surgical and medical applications. Additional information is available on the Company's Web site at www.misonix.com. With the exception of historical information contained in this press release, content herein may contain "forward looking statements" that are made pursuant to the Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, uncertainties as a result of research and development, potential acquisitions, consumer and industry acceptance, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and/or court proceedings, including the timing and monetary requirements of such activities, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company's business lines, and other factors discussed in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , subsequent Quarterly Reports on Form 10-Q Form 10-Q See 10-Q. and Current Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. .
MISONIX, INC. And Subsidiaries
Consolidated Statements of Operations
Unaudited
Three Months Ended
September 30,
2006 2005
Net sales $9,642,878 $9,111,572
Cost of goods sold 5,711,012 5,675,041
Gross profit 3,931,866 3,436,531
Selling expenses 1,597,239 1,561,634
General and administrative expenses 2,404,283 2,734,862
Research and development expenses 820,217 916,740
Total operating expenses 4,821,739 5,213,236
Loss from operations (889,873) (1,776,705)
Total other income 133,658 174,859
Loss before minority interest and
income taxes (756,215) (1,601,846)
Minority interest in net income of
consolidated subsidiaries 31,339 16,339
Loss before income taxes (787,554) (1,618,185)
Income tax benefit (245,138) (312,822)
Net loss ($542,416) ($1,305,363)
Net loss per share-basic ($0.08) ($0.19)
Net loss per share-diluted ($0.08) ($0.19)
Weighted average common shares-basic 6,900,369 6,832,622
Weighted average common shares-diluted 6,900,369 6,832,622
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