MONTVALE, N.J., June 30, 2008 (PRIME NEWSWIRE) -- Ivivi Technologies, Inc. (Nasdaq:IVVI), a leader in non-invasive, electroceutical(r) therapy systems designed to target and enhance the body's anti-inflammatory response, today announced financial results for its fiscal fourth quarter and year ended March 31, 2008.
For the fiscal year ended March 31, 2008, Ivivi reported total revenue of $1,606,441, a 36% increase from $1,182,340 reported for the fiscal year ended March 31, 2007. The increase in fiscal 2008 revenues was primarily driven by the increase in licensing sales as we commenced the initial term of our agreement with Allergan. Revenue from licensing sales and fees increased to $427,923 in fiscal 2008 and included $62,500 related to the amortization of milestone payments and royalty revenue of $1,040. This compared to $26,042 in fiscal 2007. Initial royalties from Allergan are from a pilot launch of our product to select doctors in specific geographic regions. Royalties are received by the Company in the quarter following Allergan's sale of product to their customers. Direct sales, which represent product sold into medical facilities, increased to $440,846 during fiscal 2008 from $416,292 in fiscal 2007 while rental revenue related to the wound care market decreased marginally during fiscal 2008 to $737,672 from $740,006 in fiscal 2007. The Company had a net loss of $7,503,091, or $0.74 per share, for fiscal 2008 as compared to a net loss of $7,778,611, or $1.13 per share, for fiscal 2007. The fiscal 2008 net loss reflects share based compensation expenses of approximately $1.8 million. In fiscal 2007, the net loss reflected share based compensation expenses of approximately $2.1 million and was also negatively impacted by a $1.7 million charge for net interest and financing costs.
For the three month period ended March 31, 2008, Ivivi Technologies reported total revenue of $526,094 compared to $369,166 in the comparable period in 2007, an increase of 43%. The fiscal fourth quarter included licensing sales and fees of $289,156, direct sales of $31,154 and rental revenue of $205,784. This compares to revenue from licensing sales and fees of $15,625, direct sales of $196,060 and rental revenue of $157,481 in the prior year period. The net loss for the three month period ended March 31, 2008 was $2,232,611, or $0.21 per share, compared to a net loss of $1,422,944, or $0.15 per share, for the three month period ended March 31, 2007.
On March 31, 2008, Ivivi Technologies had cash and cash equivalents of $6.6 million, no outstanding long term debt and 10,715,130 common shares outstanding.
"During fiscal 2008, we have put in place the building blocks for what we anticipate to be an important inflection point for our company," commented Andre' A. DiMino, Vice Chairman and Co-Chief Executive Officer. "We continue to compile clinical evidence that differentiates our proprietary targeted PEMF signals from others in the industry and demonstrates our effectiveness at treating a variety of diseases. We believe we have gained significant recognition for our technology over the past year, including most importantly, the results of our cardiac study at the Cleveland Clinic, Florida which are being announced simultaneously with this press release. This study demonstrated a dramatic clinical improvement in "no-option" cardiac patients, an effect comparable to patients who do have surgical options and undergo costly and invasive angioplasty procedures. We also were pleased at the recent on-line publication of a study on the significant positive effects of our targeted PEMF in the reduction of post operative pain and a concomitant reduction in the use of narcotics and other pain medications in a double-blinded randomized pilot study in breast augmentation patients. We have a number of studies planned and underway that will utilize our targeted electroceuticals(r). Of particular note is a study at Henry Ford Hospital exploring the use of our product for the treatment of pain in patients with osteoarthritis."
Providing an update on the Company's licensing arrangement with Allergan, David Saloff, President and Co-Chief Executive Officer commented, "During our fiscal fourth quarter we substantially completed the shipment of Allergan's initial 20,000 unit order. While a pilot launch of the SofPulse(r) line of products for the aesthetic and bariatric surgery markets began earlier this year, we anticipate that Allergan will expand their launch nationally. Training for the Allergan sales force has been ongoing and additional promotional efforts including sampling, physician and patient brochures and other awareness programs are now fully in place. While it has taken longer than initially expected to get to a national launch, we are confident in Allergan's commitment to the product and believe that we will soon see important progress in getting our product into doctors' and patients' hands."
Mr. Saloff added, "On the wound care side of our business, we continue to make gains with Regency Hospital Company, a leading owner/operator of Long Term Acute Care (LTAC) hospitals across the United States, as well as with other U.S. based LTACs. We have completed a successful evaluation with one of the largest LTACs in the U.S. which has resulted in a roll-out into the first eight of their more than 80 hospitals. With the presentation of five clinical case studies in the last four months at both national and international forums including The Symposium on Advanced Wound Care (SAWC) in San Diego and World Union of Wound Healing Societies (WUWHS) in Toronto, we are beginning to see more significant clinical recognition and adoption. Advantages such as improved rates of wound healing, a reduction in the use of more costly negative pressure wound therapy device rentals, and overall per patient cost savings continue to generate evaluations. We have also seen interest from outside the U.S. and have plans to target strategic distributors in Europe to help expand the use of our technology abroad."
Steven M. Gluckstern, Chairman concluded, "Inflammation plays a key role in a number of diseases, positioning our technology in a number of significant markets. The potential importance of our technology in the treatment of coronary artery disease, which affects over 16 million people in the U.S. alone, cannot be overstated. In addition, early results from our core scientific and animal research with respect to the application of our technology in a range of neuro degenerative diseases, such as Parkinson's and Alzheimer's, appear to be very promising. While we will of course continue to expand our presence in the wound care, post surgical and pain areas which have been the Company's historical areas of concentration; cardiology and neurology will now represent the key future areas of focus and investment for the Company."
FDA Matters
Our medical devices are subject to extensive and rigorous regulation by the FDA, as well as other federal and state regulatory bodies. In February, 2007, in response to inquiries from the FDA, the Company voluntarily submitted a 510(k) for its current products, the SofPulse M-10, Roma and Torino PEMF products. The Company has had discussions with the FDA regarding its application and it received various requests from the FDA for additional information, which information has been delivered to the FDA. Following the delivery of such information, the Company received a letter from the FDA regarding its voluntarily submitted 510(k) for its current products, the SofPulse M-10, Roma and Torino PEMF products. The letter stated that the FDA determined that such products are not substantially equivalent to other devices cleared for marketing through the 510(k) process or otherwise legally marketed prior to May 28, 1976. The Company believes the FDA made an incorrect assessment of the data and the Company has undertaken efforts to have the FDA reconsider the information it has provided by informally appealing the FDA determination while maintaining the ability to formally appeal pursuant to established FDA regulations and guidance. The Company discussed its position with the FDA in a meeting conducted in early June 2008 and sent the FDA further information subsequent to the meeting as requested by the FDA. The Company is awaiting the FDA's response to the meeting and subsequent submission. The Company believes based upon regulations and guidance published by the FDA, as well as discussions with its independent expert consultants, including former FDA officials, that all of its current products are covered by the FDA clearance provided in 1991. Based upon the safety and efficacy of the Company's products, it does not believe the FDA will require it to cease marketing and/or recall current products which have been already sold, or rented. However, if the Company is unsuccessful in its efforts to have the FDA reconsider the data and it does not modify its determination, the FDA may require the Company to do so until FDA marketing clearance is obtained. In addition, the FDA could subject the Company to other sanctions set forth under "Government Regulation" in the Company's Annual Report on Form 10-KSB for the fiscal year ended March 31, 2008.
Conference Call
Management will discuss the Company's results for its fiscal year ended March 31, 2008, during a conference call scheduled for today, Monday, June 30, 2008 at 4:30 pm ET. Shareholders and other interested parties may participate in the conference call by dialing (877) 407-0781 approximately 5 to 10 minutes before the beginning of the call. International callers should dial (201) 689-8568. If you are unable to participate, a replay of the call will be available until midnight on July 14, 2008 by dialing (877) 660-6853 and using pass code # 286 and conference ID # 288959. International callers should dial (201) 612-7415 and use the pass codes listed above. The call will also be broadcast live on the Investor Relations section of the Company's website www.ivivitechnologies.com and at www.InvestorCalendar.com. An archive of the call will also be available on the Company's website for 90 days.
ABOUT IVIVI TECHNOLOGIES, INC.
Based in Montvale, NJ, Ivivi Technologies, Inc. is a medical technology company focusing on designing, developing and commercializing its proprietary electrotherapeutic technology platform. Ivivi's research and development activities are focused specifically on targeted pulsed electromagnetic field, or tPEMF(tm), technology, which, by creating a therapeutic electrical current in injured soft tissue, modulates biochemical and physiological healing processes to help repair the injured tissue and reduce related pain and inflammation. The Company's Electroceuticals(r) have been used in non-invasive treatments for a wide array of conditions, including chronic wounds, pain and edema following plastic and reconstructive surgery and chronic inflammatory disorders.
FORWARD-LOOKING STATEMENTS
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to our future studies, strategic partnerships and future sales. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the Company's limited operating history, history of significant and continued operating losses and substantial accumulated earnings deficit, difficulties with its financial accounting controls, the failure of the market for the Company's products to continue to develop, the inability for customers to receive third party reimbursement, the inability to obtain additional capital, the inability to protect the Company's intellectual property, the loss of any executive officers or key personnel or consultants, competition, changes in the regulatory landscape or the imposition of regulations that affect the Company's products and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's From 10-KSB for the fiscal year ended March 31, 2008. The Company assumes no obligation to update the information contained in this press release.
IVIVI TECHNOLOGIES, INC.
Statements of Operations
Three Months Ended Year Ended
March 31, March 31,
(unaudited) (audited)
-------------------------- --------------------------
2008 2007 2008 2007
------------ ------------ ------------ ------------
Revenues:
Rentals $ 205,784 $157,481 $737,672 $740,006
Licensing
sales
and fees 289,156 15,625 427,923 26,042
Direct sales 31,154 196,060 440,846 416,292
------------ ------------ ------------ ------------
526,094 369,166 1,606,441 1,182,340
------------ ------------ ------------ ------------
Costs and
expenses:
Cost of rentals 10,076 25,393 48,725 94,043
Cost of
licensing
sales 377,695 -- 495,008 --
Cost of
direct sales 8,605 28,296 108,841 87,040
Research and
development 573,042 503,852 2,115,049 2,201,575
Sales and
marketing 605,091 355,763 2,012,969 1,307,069
General and
administrative 1,247,579 976,660 4,628,182 3,579,636
------------ ------------ ------------ ------------
Total operating
expenses 2,822,088 1,889,964 9,408,774 7,269,363
------------ ------------ ------------ ------------
(2,295,994) (1,520,798) (7,802,333) (6,087,023)
Interest income
(expense), net 63,383 97,854 299,242 (1,665,761)
Change in fair
value of
warrants &
registration
rights
liabilities -- -- -- (25,827)
------------ ------------ ------------ ------------
Loss before
provision for
income taxes (2,232,611) (1,422,944) (7,503,091) (7,778,611)
Provision for
income taxes -- -- -- --
------------ ------------ ------------ ------------
Net loss $(2,232,611) $(1,422,944) $(7,503,091) $(7,778,611)
============ ============ ============ ============
Net loss per
share, basic
and diluted $ (0.21) $ (0.15) $ (0.74) $ (1.13)
============ ============ ============ ============
Weighted
average shares
outstanding 10,697,346 9,553,380 10,073,373 6,875,028
============ ============ ============ ============
IVIVI TECHNOLOGIES, INC.
Balance Sheet
March 31, March 31,
2008 2007
------------- -------------
(audited) (audited)
Current assets
Cash and cash equivalents $ 6,600,154 $ 8,310,697
Accounts receivable, net 319,007 224,349
Inventory 111,951 236,735
Deposits with affiliate - net 241,828 --
Prepaid expenses 141,148 154,730
------------- -------------
Total current assets 7,414,088 8,926,511
Property and equipment, net 405,793 46,040
Inventory, long term 115,885 --
Equipment in use and under rental
agreements, net 155,834 60,096
Intangible assets, net 615,064 270,826
Restricted cash 48,167 --
------------- -------------
Total assets $ 8,754,831 $ 9,303,473
============= =============
Current liabilities:
Accounts payable and accrued expenses 1,029,143 $1,005,975
Advances payable - affiliate -- 36,657
------------- -------------
Total current liabilities 1,029,143 1,042,632
Deferred revenue 411,458 473,958
------------- -------------
Total liabilities 1,440,601 1,516,590
Stockholders' equity:
Common stock 26,183,516 20,922,154
Additional paid-in capital 12,346,187 10,577,111
Accumulated deficit (31,215,473) (23,712,382)
------------- -------------
Total stockholders' equity 7,314,230 7,786,883
------------- -------------
Total liabilities and
stockholders' equity $ 8,754,831 $ 9,303,473
============= =============