For Wednesday, January 7th
ADXS, CIRT, IDEV, MMAB, STKR, ELGX
Our Stocks to Watch tomorrow include Advaxis Inc. (OTCBB: ADXS), Cardio Infrared Technologies Inc. (OTC: CIRT), Indevus Pharmaceuticals Inc. (Nasdaq: IDEV), Municipal Mortgage & Equity LLC (OTC: MMAB), StockerYale Inc. (Nasdaq: STKR) and Endologix Inc. (Nasdaq: ELGX).
ADVAXIS INCORPORATED (OTCBB: ADXS)
"Up 100.00% on Tuesday"
Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes (“Lm”) cancer vaccines based on technology developed by Dr. Yvonne Paterson, Professor of Microbiology at the University of Pennsylvania and Chairperson of Advaxis’ Scientific Advisory Board. Advaxis is developing attenuated live Listeria-based vaccines that deliver engineered tumor antigens, which safely stimulate multiple simultaneous immunological mechanisms to fight cancer. Advaxis’ lead Listeria vaccine candidate, Lovaxin-C, targets human papilloma virus (“HPV”)-associated cancers such as cervical and head and neck. Current Lm vaccines in development target prostate, breast, ovarian and other cancers. Recently, Advaxis completed a Phase I clinical trial of Lovaxin-C. A Phase II clinical trial is planned for patients with cervical intraepithelial neoplasia (“CIN”). The Lm platform also has applications in the fields of infectious disease and autoimmune disorders.
January 6 -
Advaxis Phase II Clinical Trial HOLD Lifted U.S. FDA Approves Investigational New Drug Application for Phase II for Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial
Advaxis Inc. (OTCBB: ADXS), a biotechnology company, received permission from the U. S. Food and Drug Administration (FDA) to test its lead drug candidate, Lovaxin C, in patients with grade 2/3 cervical intraepithelial neoplasia (CIN). With this approval of the Investigational New Drug (IND) application for Lovaxin C, the FDA “HOLD” on Advaxis’ clinical program has been lifted.
Advaxis submitted its IND application to the FDA in May 2008, which outlined the proposed protocol for a Phase II clinical trial safety study targeting CIN – a precursor condition to cervical cancer, commonly diagnosed by PAP smears. The proposed trial, unlike Advaxis’ Phase I cervical cancer trial, will target the disease at a much earlier stage of development and recruit CIN patients living in the U. S. that are otherwise healthy. Due to the different patient population, the FDA requested more information to support the safety of Lovaxin-C and the methods used in its manufacture, which prompted the clinical trial “HOLD.”
Regarding the FDA’s acceptance of the Company’s IND application, Advaxis’ Executive Director of Product Development, Dr. Christine Chansky, MD, JD, said, “Advaxis’ clinical and scientific team comprehensively responded to the FDA’s questions. There were well over 700 pages of documentation submitted, which included results from our Phase I clinical trial study as well as animal research conducted specifically for the response. It was a great job by the team and a fine start to our regulatory relationship with the FDA. The FDA has requested additional information regarding our manufacturing processes as they develop, which we will provide as the processes are validated.”
Addressing the CIN trial’s expectations, Advaxis’ Executive VP of Science & Operations Dr. John Rothman commented, “This study is a blinded, randomized and placebo-controlled trial of sufficient size; to build upon the promising results of our Phase I study in metastatic cervical cancer patients. In this study however, we are treating healthier women with stronger immune systems and with much less disease burden. We believe that this work will provide us with meaningful support that our live, Listeria-based drug delivery system can safely resolve CIN before it becomes invasive cervical cancer, and without the adverse events that currently attend surgical treatment.” The Company anticipates commencing the trial in the second or third quarter of 2009.
CIN is a cervical condition caused by the sexually transmitted human papilloma virus (“HPV”), which can lead to invasive cervical cancer, if not diagnosed properly and left untreated. Recently developed vaccines can prevent disease if administered before HPV is contracted but do not treat the disease, and cannot be used to treat women who have already been exposed to HPV. Today, the accepted treatment protocol for late stage CIN is surgery, which is performed to preclude invasive cancer. Surgical treatment of CIN is associated with various adverse events and may render the cervix incompetent to come to a full term pregnancy.
“The FDA’s approval of Advaxis’ IND application to conduct the first US based clinical trial of a live Listeria monocytogenes vaccine that secretes an LLO-tumor specific antigen fusion is a major milestone for the Company as well as for the entire field of immunotherapy,” commented Advaxis Inc.’s Chairman and CEO, Thomas A. Moore. “Our technology enables the delivery of a tumor specific antigen fused to the highly adjuvant Listeria protein, Listeriolysin O (“LLO”), which has a very powerful, anti-tumor effect. Although we have an active clinical program in invasive cervical cancer planned, the safety and efficacy results in the CIN indication will enable us to pursue a U. S. market of about 250,000 patients per year; 50 times the market size of cervical cancer.”
ABOUT THE LOVAXIN-C VACCINE
Advaxis’ technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Bioengineered Listeria that are attenuated and secrete Advaxis’ proprietary fusion protein, have the ability to generate a robust immune response, break immune tolerance to cancer and produce an unusually strong and effective multi-level therapeutic immune response to existing cancer and other diseases.
Advaxis’ Listeria-based technology is based on over a decade worth of work by Dr. Yvonne Paterson in her laboratory at the University of Pennsylvania. The Company’s proprietary antigen fusion protein technology, stimulates innate immunity, both arms of the adaptive cellular immune system, suppresses regulatory T-cells that inhibit many vaccines in the function of activated tumor-killing cells and has other anti-tumor effects.
Unlike prophylactic vaccines, Lovaxin-C was designed to treat women who have already developed cervical cancer as a result of contracting an HPV infection, which is the most prevalent sexually transmitted disease in the US. Current products on the market are ineffective in treating HPV-infected women.
CARDIO INFRARED TECHNOLOGIES INCORPORATED (OTC: CIRT)
"Up 100.00% on Tuesday"
Cardio Infrared Technologies, Inc. is a technology and marketing company, which is focused on developing the revolutionary and evolutionary process of combining exercise equipment with medical benefits that go far beyond the normal benefits of standard exercise equipment. Cardio Infrared Technologies, Inc. is committed to continue to market this equipment to the exercise and medical markets and to aggressively expand the market to every country around the world. The equipment has already been featured on "Good Morning America" and "The View." Cardio Infrared Technologies, Inc. also has an aggressive growth plan that includes acquisitions and development of innovate new equipment and programs in the exercise and medical industries.
January 6 -
Cardio Infrared Technologies Inks Huge New Sale to Quantum Energy Health Centre's of Canada
Cardio Infrared Technologies, Inc. (OTC: CIRT), a leading Health and Wellness technology and marketing company, announced the completion of nearly one year's efforts and successful sale of the Cardio-Cor ExerBike to Quantum Energy Health Centre's of Toronto, Canada.
Wayne Bailey, President and CEO of Cardio Infrared Technologies, Inc., stated, “The sale to Quantum Energy Health Clinics by our National Sales Director, Carol Anglin, is the first of many to be placed in the franchise operations of this Toronto, Canada-based Health and Wellness company. This first unit will be installed in the flagship location as a prototype for the balance of their franchise operations. The Cardio-Cor will be located within the epicenter of the finance, entertainment, and shopping districts of one of North America's most dynamic cities, Toronto, Canada; a city of more than 2.7 million people, qualifying it as the largest city in Canada.
Quantum Energy, owned and operated by Bob Dunn and John Sargent, is a 3 yr. old Health and Wellness company. Cardio-Cor's first meeting with the owners was last year at the Anti-Aging Show in Las Vegas, where it became apparent that a synergistic relationship between the two companies was emerging and would eventually become a viable partnership. Mr. Sargent has been in the holistic health industry for over 25 years, working with literally thousands of clients, and became involved with state-of-the-art technologies as a result of a mobile clinic he operated for 8 years in Canada. He worked with cutting edge 'live blood cell microscopy' technology which pinpoints the nutritional quality of the blood. Having known Mr. Dunn for more than 20 years, he sought him as a partner for his knowledge of new business startups and his expertise in the fields of finance, accounting, marketing, and strategic planning. Together they formed the Quantum Energy Health Clinics. They have trained over 1500 people across North America on specific technologies relating to their pattern of wellness. Many of those people came back to Quantum wanting a sustainable business model which Bob developed as a result of reviewing many different modalities to improve people's health. Their concept, known as Urban DeTox, encompassed the theory of Evaluate, Eliminate, and Rejuvenate. This is where the Cardio-Cor came in due to its ability to detoxify the body and lower inflammation. Both Bob and John knew that the biggest expense to the healthcare system was Chronic Illness which accounts for 70% of the systems expenditures and that 9 out of 10 people have nutritional and digestive issues. Due to the success their clients are currently achieving, the program enjoys a 90% compliance rate because they can see how their bodies are responding within a short space of time and are therefore willing to continue on the program with vigor.
Quantum is now in the process of franchising this exciting new concept in wellness as an investor-based business. These investors themselves and their families have been helped tremendously with the program and now want to see this concept taken worldwide. Their question to Bob was, “How quickly can you set up 1,000 clinics?” Bob has agreed to the implementation of approximately 250 clinics in the year 2009 and will be including the Cardio-Cor as part of the recommended equipment for each new Centre.
Quantum is currently looking at locations that have sustainable high visibility such as downtown and suburbia malls with good traffic flow. Their standard clinic will be somewhere between 2,000 and 2,500 sq. feet with regional centers being about 5,000 sq. ft. These regional centers will have a Naturopathic Doctor on staff. Bob states, “At the core of our philosophy is a desire to bring people's bodies back into a state of homeostasis and attract good people to manage our clinics as we give them continued sound training and support, and we wish to multiply our voice so that all will benefit and realize better health and a sense of well-being than was ever thought possible. We are pleased to add the Cardio-Cor to this new and exciting venture.”
This strategic alliance and distributorship agreement with Quantum Energy Health Clinics opens up the entire Canadian market for Cardio-Cor.
INDEVUS PHARMACEUTICALS INCORPORATED (NASDAQ: IDEV)
"Up 73.55% on Tuesday "
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development, and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA® and SANCTURA XR™ for overactive bladder, VANTAS® for advanced prostate cancer, SUPPRELIN® LA for central precocious puberty, and DELATESTRYL® to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR™ for bladder cancer, NEBIDO® for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and the octreotide implant for acromegaly and carcinoid syndrome.
January 5 -
Indevus Pharmaceuticals Announces Definitive Merger Agreement With Endo Pharmaceuticals
Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced that it has entered into a definitive merger agreement under which Endo Pharmaceuticals Holdings, Inc. will commence a tender offer to acquire 100 percent of the outstanding shares of Indevus for approximately $370 million, or $4.50 per Indevus share, in cash and up to an additional approximately $267 million, or $3.00 per Indevus share, in cash payable in the future upon achievement of certain milestones related to NEBIDO ® (in development for hypogonadism) and the octreotide implant (in development for acromegaly and carcinoid syndrome), two of Indevus' primary product candidates. The up-front consideration of $4.50 per share represents a premium of 45.2% over today's closing price of the common stock of Indevus, and a 59.0% premium over the 30-day volume weighted average price for the common stock. The transaction has been approved by the boards of directors of both companies. The Company will host a conference call and webcast on January 6, 2009 beginning at 8:30 am Eastern time (details follow below).
"For many reasons, we are very pleased to bring this transaction to the shareholders and other stakeholders of the Company," said Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "For our shareholders, the deal not only captures a significant premium in the up-front portion of the consideration, but our investors will also maintain a significant interest in the downstream value creation from NEBIDO and the octreotide implant.
"Our employees, who have been so instrumental in the growth and success of Indevus, will also remain integral to the future of Endo," continued Dr. Cooper. "Our sales force, Cranbury operations, and the NEBIDO and Octreotide R&D teams are expected to play a very important role in the new Endo. In addition, Endo will look to our headquarters in Lexington, MA as a source of talent for their growing organization.
"Finally, we believe this transaction will create new value for our patients, physicians, and other customers under Endo's leadership. We believe Endo's proven commercial capabilities, targeted approach to medical marketing and unique understanding of the changes taking place in health care delivery today will ensure the success of our current and future products. We welcome and fully support this acquisition."
Under the terms of the agreement, Endo will commence a tender offer to purchase all outstanding shares of Indevus in exchange for an up-front payment of $4.50 in cash for each share of outstanding Indevus common stock ("Upfront Consideration"). In addition, Indevus shareholders will receive the non-transferrable contractual right to two contingent cash payments ("Contingent Cash Payments"), one for up to $2.00 per share and the other for $1.00 per share that could deliver up to an additional $267 million, or $3.00 per share in cash, if the Company meets certain targets.
The first Contingent Cash Payment relates to NEBIDO and is payable as follows: (i) $2.00 per share if NEBIDO is approved, within three (3) years of the closing of the tender offer, by the FDA for marketing and sale without certain restrictive labeling, or (ii) two potential payments in the event that NEBIDO is approved by the FDA with certain restrictive labeling, comprised of: (a) $1.00 per share upon such approval, if approval is obtained within three (3) years of the closing of the tender offer and (b) an additional $1.00 per share following the achievement of a certain sales threshold milestone during the first five (5) years from the date of the first commercial sale of NEBIDO.
The second Contingent Cash Payment relates to the octreotide implant and consists of $1.00 per share to be paid in the event that, within four (4) years of the closing of the tender offer, octreotide is approved by the FDA for marketing and sale for the treatment of acromegaly or carcinoid syndrome.
The tender offer is expected to commence within 5 days of the signing of the Merger Agreement and will remain open for 45 calendar days, subject to extension under certain circumstances. The tender offer closing is conditioned on the tender of a majority of the outstanding shares of Indevus' common stock, antitrust clearance and other customary closing conditions. The executive officers and directors of Indevus and certain of their affiliates, have agreed to tender approximately 4.7% of Indevus' outstanding shares in the tender offer.
UBS Securities LLC advised Indevus and provided a fairness opinion to Indevus' board of directors. Burns & Levinson LLP acted as legal counsel to Indevus.
Conference call and webcast
The live call may be accessed by dialing 800-561-2601 from the U.S. and Canada, and 617-614-3518 from international locations. The participant passcode is 42185623. Investors are advised to dial into the call at least ten minutes prior to the call to register. A replay of the call will be available beginning at 11:00 AM on January 6, 2009 and lasting until 12:00 AM on February 4, 2009. To access the replay, please dial 888-286-8010 from the U.S. and Canada, and 617-801-6888 from international locations, using the passcode 94686397.
The press release and the live webcast will be accessible by visiting the Investors section of the Company's website, www.indevus.com. An archived version of the call will be accessible at the same web address for 30 days following the live call.
NEBIDO is a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.
The Indevus octreotide implant is a proprietary formulation of octreotide in a six-month implant utilizing the Company's patented HYDRON® Polymer Technology. The implant is inserted subcutaneously in the inner aspect of the upper arm and is specifically designed to provide a continuous release of octreotide, a long-acting octapeptide that mimics the natural hormone somatostatin to block release of growth hormone (GH), over a six-month period.
ABOUT ENDO PHARMACEUTICALS
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain. Its products include LIDODERM®, a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET® and PERCODAN® tablets for the relief of moderate-to-moderately severe pain; FROVA® tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA® tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA® ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and VOLTAREN® gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, anesthesiology, oncology, and primary care.
MUNICIPAL MORTGAGE & EQUITY LLC (OTC: MMAB)
"Up 66.36% on Tuesday"
Municipal Mortgage & Equity LLC ("MuniMae") and its subsidiaries arrange debt and equity financing for developers and owners of real estate and clean energy projects. Assets under management as of September 30, 2008 exceeded $20.4 billion including investments in over 3,000 properties, containing about 328,000 units in 49 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. MuniMae is organized as a limited liability company, which allows it to combine the limited liability, governance and management characteristics of a corporation with the pass-through tax features of a partnership. MuniMae also conducts activities through wholly owned taxable corporate subsidiaries.
December 22 -
MuniMae Announces Sale of Agency Business
Provides Update on Third Quarter 2008 Production Numbers, Restatement, and Other Business Initiatives
Municipal Mortgage & Equity, LLC (OTC: MMAB) ("MuniMae" or "the Company") announced the sale of its Agency lending operations. It also announced its third quarter 2008 production numbers and provided an update on various business initiatives and the anticipated completion of the restatement of its 2004 and 2005 financial statements and its 2006 financial statements.
Sale of Agency Business
MuniMae announced today an agreement to sell its Agency loan operations to Oak Grove Commercial Mortgage, LLC, a newly formed subsidiary of Mud Duck Equities LLC. The two part transaction consists of a $10 million bridge loan from Oak Grove, accompanied by an Acquisition Agreement pursuant to which Oak Grove will acquire the business. Upon closing of the sale, MuniMae will receive $23.5 million in a combination of cash and forgiveness of the loan and, in addition, will receive two series of dividend paying preferred interests in Oak Grove having a combined principal amount of $47 million (subject to reduction of a portion of the preferred interests under some circumstances). MuniMae’s Agency business consists of the underwriting and origination of affordable housing and market rate multifamily apartment project loans that are sold to or insured or guaranteed by the government-sponsored enterprises Fannie Mae, Freddie Mac and government agencies HUD/FHA. MuniMae originates and, in most cases, sells the loans to these agencies, and remains engaged as the loan servicer, for which MuniMae is paid a servicing fee.
The loan from Oak Grove was funded on December 18, 2008. Completion of the sale transaction is subject to a number of conditions, including approval by the government-sponsored agencies to which MuniMae sells, or which insure the loans it originates in this aspect of its business.
Total MuniMae Agency loan originations in the first three quarters of 2008 were $875 million up from $625 million in the same period in 2007.
Michael F. Falcone, Chief Executive Officer stated, “This sale is an important transaction for MuniMae as it provides us with working capital in this difficult operating environment.”
Third Quarter 2008 Production
Third quarter 2008 production (debt and equity originations) was $349 million, compared to $754 million in the prior year period, due primarily to the impact of the ongoing disruption in the capital markets on our businesses and the Company’s decision to curtail business activities. Production in MMA Financial, the Company’s affordable housing business, included approximately $29 million in tax credit equity placements, compared to $81 million in the prior year period and $99 million of permanent loan originations, compared with $39 million in the prior year period. MMA Realty Capital production included approximately $120 million in agency originations and approximately $80 million in non-agency originations, compared to $152 million and $259 million, respectively, in the prior year period. Production in the Company’s MMA Renewable Ventures unit was $21 million, compared to $44 million in the 2007 period.
Mr. Falcone stated, “Our production numbers continue to reflect the extremely difficult operating environment. As a result of these conditions, we continue to restrict our business activities, conserve our resources and explore strategic alternatives.”
Consistent with its previous two quarters and the need to conserve capital, the Company will continue the suspension of its quarterly dividend for the third quarter of 2008.
Strategic Alternatives & Asset Sales
On June 26, 2008, MuniMae announced that it was engaged in evaluating strategic alternatives for the Company. In addition to today’s announcement of an agreement to sell the Agency business, the Company continues to be in discussions with potential buyers for other business units. There is no assurance that this process will result in any transactions.
MuniMae continues to be in regular contact with its lenders regarding its borrowings and credit support agreements. While the Company’s lenders have been cooperative, as previously announced, some lenders have been reluctant to formally waive various covenants in their agreements relating to the delivery of audited financial statements. The Company's failure to deliver these statements constitutes a default on several loan arrangements which could allow the affected lenders to call some of these loans.
As part of its broader business strategy moving forward, the company stated it will move away from non-core business operations. The Company announced it is exiting the advisory business, although its joint venture, International Housing Solutions, will continue to provide advisory services to institutional investors. In conjunction with exiting the advisory business, the Company delivered termination notices to certain of its advisory clients and was terminated by other advisory clients. The Company also intends to reduce its third party loan brokerage business, in particular, its California operations, which the Company does not view as being material to its business plan.
Mr. Falcone stated, “As long as the capital markets remain constrained, we will not pursue the continuation of marginal businesses. Our primary focus will be capital conservation and liquidity until a more normal market begins to emerge, which may be quite some time.”
Update on Restatement
The Company believes it is close to completing and releasing its audited consolidated financial statements of MuniMae and subsidiaries, including consolidated balance sheets as of December 31, 2006 and 2005, and the related consolidated statement of operations, comprehensive income, shareholders’ equity and cash flows for each of the years in the three-year period ended December 31, 2006. These financial statements include the impact of the Company’s restatement for the years ended December 2005 and 2004 as well as the cumulative impact on shareholder equity through December 31, 2005. As part of the ongoing financial statement preparation and accounting processes, the Company is implementing significant changes in its business and accounting practices and policies. The Company also announced that it is now current in its financial reporting as it relates to its more significant wholly owned subsidiaries, including MuniMae TE Bond Subsidiary, LLC and its MMA Mortgage Investment Corporation.
STOCKERYALE INCORPORATED (NASDAQ: STKR)
"Up 31.17% on Tuesday"
StockerYale, Inc., headquartered in Salem, New Hampshire, is an independent designer and manufacturer of structured light lasers, LED modules, and specialty optical devices for industry leading OEMs. In addition, the company manufactures fluorescent lighting products and phase masks. The Company serves a wide range of markets including the machine vision, industrial inspection, defense, telecommunication, sensors, and medical markets. StockerYale has offices and subsidiaries in the U.S., Canada, and Europe.
January 6 -
StockerYale Announces Multi-Million Dollar Supply Agreement With Boston Scientific Largest Bio-Medical Contract to Date; StockerYale Products to be Sold for Surgical Applications by Boston Scientific
StockerYale, Inc. (Nasdaq: STKR), a leading designer and manufacturer of structured light lasers, LED modules and specialty optical assemblies for industrial OEMs, medical and defense markets, announced that it has signed a supply agreement (“the Agreement”) with Boston Scientific Corporation (Boston Scientific), a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Under the terms of the Agreement, StockerYale will supply optical assemblies to Boston Scientific for various medical applications. Financial terms of the Agreement were not disclosed.
The signing of the Agreement follows a period of intense collaborative efforts by both parties to develop a higher-performance family of unique optical assembly products, with each company leveraging its proven technical and application expertise. StockerYale's unique expertise in optical assembly design created an assembly with significant improvements in performance and reliability. Production will commence this quarter at StockerYale's Salem, NH manufacturing facility.
“This Agreement clearly underscores the execution of our strategy to leverage core intellectual property and technical expertise and apply it to faster-growing markets; and in this circumstance, our continued focus and penetration of the medical/bio-instrumentation market,” stated Mark W. Blodgett, Chairman & CEO of StockerYale, Inc. “Furthermore, this contract represents an important milestone for StockerYale, reinforcing the capabilities of our specialty optical assembly business, of which we are the one of the last remaining, independent providers. We are currently working on several other projects with Boston Scientific and look forward to a long and mutually beneficial relationship.”
ABOUT BOSTON SCIENTIFIC
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.
ENDOLOGIX INCORPORATED (NASDAQ: ELGX)
"Up 33.61% on Tuesday"
Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft for treating abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S.
January 6 -
Endologix Expects 2008 Total Revenue Growth of 35%; Announces 2009 Financial Guidance 2008 Fourth Quarter to be 16th with Sequential Domestic Sales Growth
Endologix, Inc. (Nasdaq: ELGX), developer and manufacturer of the Powerlink® System endovascular stent graft for the minimally invasive treatment of abdominal aortic aneurysms (AAA), announces that it expects total revenue for 2008 to be approximately $37.6 million, representing a 35% increase from 2007 total revenue of $27.8 million.
Endologix expects to report total product revenue for the fourth quarter of 2008 of approximately $10.7 million, up 35% from total product revenue of $7.9 million in the fourth quarter of 2007. Domestic product revenue for the fourth quarter of 2008 is expected to be approximately $9.1 million, an increase of 35% compared with $6.7 million for the fourth quarter of 2007 and up 13% from $8.1 million for the third quarter of 2008.
“We attribute our strong 2008 sales growth and ability to exceed our revenue guidance to the increasing success of our sales force initiatives, the introduction of new products and increased physician adoption of our Powerlink System,” said John McDermott, Endologix president and chief executive officer. “Our recently launched suprarenal proximal extensions and Powerlink XL® have opened up new market segments enabling us to treat a broader AAA population. These new devices provide physicians with a wide range of treatment options and the lowest profile delivery catheter in the U.S. to treat large neck aneurysms.
“Gross margin for 2008 is expected to be approximately 72%, which compares very favorably to a gross margin of 62% for 2007. This significant gross margin improvement is due to the in-house manufacturing of ePTFE graft material which began in mid-2007, as well as volume efficiencies realized in our fully-integrated manufacturing process.”
Total cash and marketable securities as of December 31, 2008 are expected to be approximately $7.9 million.
2009 Financial Guidance
“We expect another year of strong sales growth in 2009 with anticipated revenue in the $44 million to $46 million range, which represents an increase of 17% to 22% compared with expected 2008 revenue. Gross margin is expected to continue improving in 2009 due to efficiencies from higher manufacturing volumes required to support our sales growth. Importantly, we remain confident that our cash and available resources will allow us to execute on our business plan and achieve sustainable positive cash flow from operations in the first half of 2009,” said Mr. McDermott.
“Among important milestones for 2009, we are on schedule to launch the IntuiTrak™ Delivery System in the second quarter. This new delivery system incorporates a 19Fr Introducer and 9Fr percutaneous, pre-cannulated contralateral access with new design features to simplify delivery and deployment of Powerlink devices. Physician feedback from our limited market release has been encouraging, reinforcing the importance of this device to the marketplace. We also expect continued momentum from our suprarenal proximal extensions, Powerlink XL and a series of operating initiatives, which we believe provide us with a strong foundation for long-term growth,” he concluded.
Endologix plans to report full financial results for the 2008 fourth quarter and year, and to hold an investment-community conference call on February 19, 2009 at 5:00 p.m. Eastern time (2:00 p.m. Pacific time). Additional information regarding the conference call will be made available approximately two weeks prior to the call.