This excerpt taken from the NMTI 8-K filed Oct 29, 2009.
“Our CLOSURE I trial remains the top priority for NMT,” Martin said. “We anticipate that by the time we are prepared to submit our PMA during the third quarter of 2010, 100 percent of the randomized patient follow-up data will be available. We are all eager to better understand the possible connection between PFO and stroke and TIA. Management continues to be optimistic that the results will support PFO closure with our STARFlex® device for the stroke and TIA indication versus alternative treatments.”
“We are also confident that the steps we are taking to expand our presence overseas will contribute to increased sales and provide more significant long-term growth,” said Martin. “We recently entered into a distribution arrangement in Germany with Nicolai, a partner of the Werfen Group, a leading international distributor in the healthcare industry. We currently plan to continue executing this distribution strategy in a number of overseas markets in order to capitalize on these territories.”
Davis concluded, “We currently are expecting total revenues of $13 to $14 million for the full year 2009. Going forward, we will continue to carefully manage our capital while strategically funding our R&D efforts in order to maintain our technological leadership in the marketplace. We currently expect cash and cash equivalents at year-end to be approximately $6 million. In addition, we also have a $4 million credit facility available to us, which provides us with additional financial flexibility, but we will also continue to review financing alternatives to raise additional capital, if necessary.”
This excerpt taken from the NMTI 8-K filed Aug 4, 2009.
“Looking ahead, we remain committed to advancing NMT’s position as an established technology leader in cardiac septal repair,” Martin said. “While being prudent in our spending, we will continue to fund our R&D efforts and have several promising programs underway. CLOSURE I remains our top priority and, as previously announced, at this time, we expect the data from that trial to be reviewed in the fall of 2010.”
“For the second half of 2009, we will remain focused on our four major initiatives: 1) pursuing additional regulatory approvals for our technology, inclusive of CLOSURE I; 2) increasing BioSTAR® unit sales; 3) effectively managing our capital resources; and 4) expanding our international presence in the market of structural heart repair,” said Martin. “With the new distribution partnerships in place and registrations now complete in several new markets, we have the potential to drive near-term revenue with little additional costs. Our goal is to build sales momentum toward year-end through our expanded global footprint.”
Davis concluded, “For the full year 2009, we are expecting total revenues of approximately $14 to $15 million. We will continue to review all business operations for additional expense reduction opportunities. We currently expect cash, cash equivalents and marketable securities at December 31, 2009 to be within the range of $6 to $8 million.”
This excerpt taken from the NMTI 8-K filed May 5, 2009.
“Looking ahead, our near-term emphasis will be on advancing our sales and marketing efforts by further expanding our international presence with BioSTAR®,” said Martin. “In addition to entering new markets in Europe during the first quarter, more recently we also entered the Brazilian market. We have already begun identifying other markets where we expect to roll out our products in the months ahead.”
“At the same time, we remain focused on achieving additional regulatory approval for our technologies,” said Martin. “For example, we recently received PMA approval from the FDA for STARFlex® for patients with VSD and the implant is now available for commercial use for that indication in the U.S. STARFlex® is implanted using a catheter during a minimally invasive procedure. The alternative treatment for VSD is open-heart surgery, which is considered a high-risk, invasive procedure. STARFlex®, which replaces our previous device, CardioSEAL®, is a technologically advanced implant that features a unique self-centering mechanism.”
“Overall, we remain well-positioned in our marketplace,” Martin said. “We are confident about the prospects for our pivotal CLOSURE I trial, which has the potential to define the PFO closure landscape. Despite the current economic environment, BioSTAR® has been well-received by the market and its bioabsorbable collagen matrix gives us a competitive advantage. We believe that we remain the technology leader in cardiac septal repair and have several promising programs underway.”
Davis said, “For the second quarter of 2009, we are expecting total revenues of approximately $3.8 to $4.3 million. For full year 2009, we currently anticipate total revenues of approximately $16 to $18 million. With a far leaner cost structure and CLOSURE I enrollment complete, we expect a lower cash burn in the quarters ahead. As a result, we expect cash, cash equivalents and marketable securities at December 31, 2009 to remain in the range of $6 to $8 million.”
This excerpt taken from the NMTI 8-K filed Mar 3, 2009.
“Several of our promising programs, such as CLOSURE I and BioSTAR®, are expected to achieve significant milestones during 2009,” said Martin. “Based on the positive response to BioSTAR®, we have entered new markets in Latin America and believe that we are extending our market share in Europe and Canada.”
“Most importantly, the potential to allow investigators to analyze the data of our CLOSURE I study approximately one year earlier than originally planned is very exciting,” said Martin. “Since enrollment in the trial began five years ago, more than 90 percent of the data will be at or greater than a two-year follow-up period by November 2009. The CLOSURE I Executive Committee, independent statistical experts and the FDA are determining if that is an appropriate time interval to perform the study data analysis. If so, we would then expect to submit a pre-market approval (PMA) application for the stroke and TIA indication to the FDA during the first quarter of 2010. We believe that the medical community eagerly awaits the answer to whether PFO closure or medical therapy alone provides the best risk benefit for reducing recurrent stroke or TIA.”
Davis said, “For the first quarter of 2009, we are expecting total revenues of approximately $3.9 to $4.2 million. For full year 2009, we currently anticipate total revenues of approximately $18 million. With CLOSURE I enrollment complete, and with the recently implemented cost reductions in place, our cash burn rate will decrease significantly in 2009 over 2008 levels. As a result, we expect cash, cash equivalents and marketable securities at December 31, 2009 to be in the range of $6 to $8 million.”
This excerpt taken from the NMTI 8-K filed Nov 6, 2008.
“As we conclude 2008, we remain optimistic about the future of NMT,” said Ahern. “We are bullish about the prospects for our technologies in the marketplace. We expect that our BioSTAR® implant will continue to make market share gains in Europe, Canada and other markets that we enter during the remainder of 2008 and into 2009. We are not aware of any competitor with a similar advanced bioabsorbable cardiac septal repair technology that is in human use anywhere in the world.”
“We remain extremely encouraged about our clinical progress,” Ahern said. “With enrollment now concluded, we are one step closer to completing our landmark CLOSURE I clinical trial. We continue to work with our investigators, statistical experts and the FDA on a revised plan to reduce the timing for CLOSURE I data analysis. The original design calls for a time-based two-year follow-up. Alternative plans that we are considering and have presented to the FDA may allow for an event-based data analysis in less than two years. We expect a decision by year-end.”
Davis said, “For the full year 2008, we are expecting total revenue of approximately $18 to $19 million. Now that we have completed enrollment in CLOSURE I, we expect to see a decrease in spending on our clinical trials. As a result, we continue to expect cash, cash equivalents and marketable securities at December 31, 2008 to be approximately $16 million.”
This excerpt taken from the NMTI 8-K filed Aug 5, 2008.
“Looking at the second half of 2008, we will remain focused on our two major near-term goals: establishing an even stronger presence for BioSTAR® in Europe and Canada and completing enrollment in CLOSURE I. NMT intends to be the first company to submit a PMA for the PFO/stroke/TIA indication in the U.S.,” said Ahern.
“Positive results from CLOSURE I would have a significant impact on the current clinical practice worldwide,” said Ahern. “The potential worldwide market for percutaneous PFO closure to prevent recurrent stroke and TIA is estimated to be up to $4 billion annually.”
Davis concluded, “We currently expect total revenue for the third quarter of 2008 to be approximately $4.8 to $5.2 million. For the full year, we are revising our total revenue guidance to approximately $19 to $20 million. The downward revision in our full year revenue guidance is related to the slower-than-expected ramp up of BioSTAR® sales in Europe. We will continue to invest in our ongoing clinical trials and development programs, as well as our sales and marketing strategies. As a result, we currently expect cash, cash equivalents and marketable securities at December 31, 2008 to be approximately $16 million.”
This excerpt taken from the NMTI 8-K filed May 6, 2008.
“The first quarter of 2008 has set the stage for what we expect to be a successful year as we are positioned to meet our two major goals,” said Ahern. “Our focus is on completing enrollment in our CLOSURE I trial and continuing to gain market share in Europe and Canada with BioSTAR®.”
“For CLOSURE I, we currently anticipate completing enrollment within the next couple of months,” said Ahern. “This is the first-of-its-kind, prospective, randomized controlled clinical trial designed to evaluate and compare the effectiveness and safety of both medical therapy and PFO closure. The primary endpoint will be to measure recurrent event rates in the two study arms.”
“The commercial market’s early acceptance of BioSTAR® is positive, and we are already in the pre-clinical stage for our second bioabsorbable implant, BioTREK™,” said Ahern. “Our long-term strategy is to further develop and commercialize novel, drug and biological combination septal repair technologies like BioSTAR® and BioTREK™. We believe that bioabsorbable septal repair is the future of our industry. We are not aware of any comparable, competitive device approved for use in clinical trials.”
“Looking ahead, we believe the PFO closure for the stroke and TIA indications will represent a significant opportunity, particularly on a worldwide basis,” said Ahern. “We believe our technology is most closely aligned with what the medical community and their patients will require for PFO closure. We are confident that we can meet our 2008 goals while maintaining a strong financial position and continuing to build on our leadership position in the marketplace.”
Davis concluded, “We currently expect total revenue for the second quarter of 2008 to be approximately $5.2 million to $5.5 million. For the full year, we continue to expect total revenues of approximately $24 million to $26 million. Investments in R&D will continue to accelerate as we advance our clinical trials. As a result, we currently expect cash, cash equivalents and marketable securities at December 31, 2008 to be approximately $16 million to $18 million.”
This excerpt taken from the NMTI 8-K filed Mar 5, 2008.
Our two main areas of focus for 2008 are executing our BioSTAR® rollout plan and completing enrollment in our pivotal patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) clinical trial, CLOSURE I, said Ahern. We believe we are on track to be the first to complete enrollment and submit data for U.S. regulatory approval for a PFO/stroke and TIA indication. We believe that positive data from CLOSURE I will also support wider acceptance of our PFO closure technologies outside of the U.S. To date, approximately 800 of the required 900 patients are enrolled in CLOSURE I and we expect to complete enrollment in the study by midyear.
We are encouraged by the customer response to our BioSTAR® bioabsorbable septal repair technology, continued Ahern. The positive feedback provides an early validation to our overall biological repair strategy and our plans to further develop and commercialize novel device, drug and biological combination technologies, like BioSTAR®. Preclinical trials are already underway for our second biological repair platform, BioTREK. As with BioSTAR®, BioTREK is designed to repair and regenerate tissue, exhibit no toxic behavior and, over time, be completely absorbed by the body. BioTREK utilizes a new class of biopolymers derived from recombinant DNA technology and can be programmed for specific tissue repair.
Earlier this year we closed down the MIST II PFO/migraine clinical trial, said Ahern. It became obvious to us that the trial could not enroll the necessary number of patients in a reasonable time frame and at an acceptable cost. We continue to strongly believe there is a link between right to left shunts through a PFO and migraine headaches in some patients. Results from our MIST study demonstrate a treatment effect of PFO closure in certain migraine headache patients. Those results, which will be published later this month in Circulation, the official journal of the American Heart Association, support further investigation of the PFO/migraine connection. We intend to continue our
This excerpt taken from the NMTI 8-K filed Nov 8, 2007.
NMTs clinical efforts and technology development programs are as strong as ever, continued Ahern. We are confident in our septal heart repair devices and the potential benefit they can provide for stroke and other neurological events. As we head into the final months of 2007, we remain focused on the successful introduction of BioSTAR® and progression of our ongoing trials.
NMT is positioned for another exciting year in 2008, said Ahern. We currently expect to meet important milestones during the year, including: completing enrollment in our CLOSURE I stroke trial early in the year; the further evolution of our development program for our second bioabsorbable device, BioTREK; and, by late 2008, obtaining deeper insight on BioTREK from pre-clinical studies, along with establishing an expected timeline for a first in-man trial. In the meantime, we are anticipating an increase in the adoption rate of BioSTAR® by cardiologists and medical professionals in Europe and Canada, thus increasing our implant sales in those regions. Overall, we remain confident that NMT can maintain and strengthen its leadership position in the area of structural heart repair.
Davis concluded, For the fourth quarter of 2007, we expect total revenue, inclusive of the royalty from Bard, to be approximately $5.7 million. As previously mentioned, our R&D investments will continue to increase for our ongoing clinical trials and development programs in the U.S., Europe and Canada during the fourth quarter and
This excerpt taken from the NMTI 8-K filed Aug 7, 2007.
NMT accomplished numerous milestones during the first half of 2007, and we expect to achieve additional milestones in the latter half of the year, Ahern said. In July we commenced the market launch of BioSTAR® in Europe and Canada and, as a result, combined with our investments in our sales and marketing infrastructure, we are anticipating a continued increase in implant sales. Also, we expect to satisfy the enrollment requirement for our U.S. clinical studies for stroke and migraine, CLOSURE I and MIST II in early 2008.
With the recent approvals of BioSTAR®, we believe that NMT has strengthened its position as the clear front-runner in the PFO treatment space, said Ahern. We expect that this unique biomaterial, drug and device combination will help to expand the Companys market share for this opportunity. Based on meetings we have held with interventional cardiologists across Europe, we believe BioSTAR® will be widely accepted as a beneficial treatment for septal heart defects.
Davis concluded, Keeping in mind that BioSTAR® has just launched in Europe and Canada, we expect third-quarter 2007 total revenues to be approximately $6.6 million, a modest increase versus the second quarter just announced. Although we expect North American sales to remain consistent with the levels we have been seeing for several quarters, going forward we currently expect to achieve an increase in our European market share. In addition, as enrollment in our ongoing CLOSURE I and MIST II trials continues to accelerate, we project an increase in R&D expenses throughout the remainder of the year. We currently anticipate ending 2007 with approximately $23.0 million in cash, cash equivalents and marketable securities.
This excerpt taken from the NMTI 8-K filed May 8, 2007.
Ahern said, We are encouraged by the recent FDA approval of our revised statistical plan for CLOSURE I, which included a reduction in required enrollment to approximately 800 patients from 1,600. With more than 650 patients already randomized, we currently anticipate completing enrollment by year-end. Upon completion of enrollment, patients will participate in a two year follow-up program. Our target is to be the first company to complete a randomized controlled trial and to submit a PMA to the FDA for these indications, which represent a potential market of more than 250,000 U.S. patients annually. Other milestones on our horizon include the BioSTAR® launch in Europe and Canada, both of which we expect prior to the second half of 2007. We also currently anticipate the completion of MIST II enrollment by year-end and publication of the MIST results by mid-year.
We remain committed to our goal to be the leader in the structural heart repair market, said Ahern. We continue to consistently introduce the most technologically advanced products in the industry. The latest product in our pipeline, BioTREK, is a unique device that is 100% absorbed as a noninflammatory natural metabolite. We believe that the initial feedback from the medical community validates our view that this product, like BioSTAR®, will be extremely well-received in the marketplace.
Davis concluded, Due to the later than anticipated CE Mark approval of BioSTAR®, we currently expect second-quarter 2007 total revenues to be approximately $6.4 million, a modest decrease versus the second quarter of 2006. We continue to expect sales in Europe to increase following the anticipated approval of BioSTAR®. Additionally, over the next several months we expect North American sales to remain consistent with last years levels. As a result of the progress in our ongoing clinical trials, including the changes to the CLOSURE I trial, we have adjusted our guidance to reflect a reduction in spending and currently anticipate ending 2007 with approximately $22 million in cash, cash equivalents and marketable securities.
This excerpt taken from the NMTI 8-K filed Mar 6, 2007.
The past year was a landmark period for NMT Medical, as we accomplished many clinical, regulatory and operational milestones, said Ahern. There are four primary milestones that we expect to achieve in 2007. First, we currently expect to launch BioSTAR® in Europe and Canada in early to mid 2007, following their respective, anticipated regulatory approvals. We anticipate BioSTAR® will substantially increase our market share. Second, we expect to experience robust enrollment of patients in MIST II in the U.S. There are two competitive PFO/migraine trials in the U.S. that we believe have all been slow to enroll. We anticipate that the positive outcome data from our predicate MIST trial, and the addition of the newest bioabsorbable septal repair implant, BioSTAR®, will make MIST II more attractive to the clinical and patient population. Our third milestone is to continue to collaborate with the FDA and our experts to develop a plan to complete enrollment in CLOSURE I while maintaining the scientific integrity of the trial.
On March 2, 2007 the FDA held a public and private advisory panel meeting in order to discuss and subsequently make recommendations regarding the clinical trial design for PFO closure devices intended to reduce recurrent stroke. While the official recommendation has not yet been published, the FDA and advisory panel concurred that only randomized, controlled trials would provide the data necessary to be considered for pre-market approval. NMT provided the FDA and advisory panel with its plan to complete the Closure I study. Included in the plan is a protocol specified interim analysis of the study data. NMT is blinded to that data, but is able to ask if a revised statistical plan, under consideration by NMT and its investigators and advisors, is appropriately powered. If the revised plan is appropriate and approved by the FDA, NMT will be able to provide more accurate guidance on the time needed to complete enrollment. We expect to have guidance within the next 90 days. Lastly, we currently anticipate publication of the MIST migraine information in a peer-reviewed journal during the first half of 2007.
The developments of the past year further solidify our leadership position in PFO closure and have set the stage for additional growth opportunities in the emerging structural heart repair arena, said Ahern. Our septal repair implants, CardioSEAL® and STARFlex®, have been successfully implanted in more than 23,000 heart repair procedures to date, and we are anxiously awaiting the market launch of our first next-generation implant, BioSTAR®. We believe that NMT is well positioned for another year of success in 2007.
Davis concluded, We currently expect first-quarter 2007 total revenues to be relatively flat when compared with the first quarter of 2006. We expect sales in Europe to increase going forward based upon the anticipated CE Mark approval. In North America we expect sales to remain relatively stable as we continue to move our clinical programs forward with the goal of achieving additional regulatory approvals. In addition, we currently expect to accelerate spending in our ongoing clinical trials in the U.S. and UK, and investments in our next generation PFO closure technologies, BioSTAR® and BioTREK. As a result, we currently anticipate ending 2007 with $17 to $20 million in cash, cash equivalents and marketable securities.
This excerpt taken from the NMTI 8-K filed Nov 9, 2006.
Ahern said, NMT accomplished several key milestones during the third quarter. We continue to execute on our business strategy, which has enabled the Company to consistently deliver on its commitment to remain the leader in the structural heart repair market by providing the most technologically advanced implants. We plan to continue this momentum through the fourth quarter and into 2007. BioSTAR® remains on track to receive CE Mark approval in Europe prior to the year-end. Our product pipeline remains strong as the research program for our next biological closure implant, BioTREK, is in the pre-clinical stages. We believe that our biological closure devices continue to surpass other alternatives, giving us the competitive advantage in the structural heart repair market.
Davis concluded, For the fourth quarter of 2006, with the anticipated approval of BioSTAR®, our investments in Europe will increase and we expect a corresponding increase in implant sales. As a result, we currently expect a 2% to 4% increase in fourth-quarter 2006 total revenues compared with the fourth quarter of 2005. Going forward, we will continue to focus on the anticipated European approval of BioSTAR® and the further progression of our clinical trials - MIST II and CLOSURE I in the U.S. and MIST III in the UK. In addition, we will continue to evaluate the potential impact of the voluntary HDE withdrawal on product revenue in the United States. In light of this broad range of activities, we continue to see an acceleration in spending. With that in mind, we currently anticipate ending 2006 with $32 to $34 million in cash, cash equivalents and marketable securities.
This excerpt taken from the NMTI 8-K filed Aug 3, 2006.
Ahern said, The outlook for NMT in the second half of 2006 remains promising. We anticipate achieving several milestones during that time, including the European approval of BioSTAR. We expect a sales ramp in Europe during the second half of the year. We believe BioSTAR is a significant step forward for NMT and affirms our technology leadership in the PFO closure marketplace. And lastly, we are optimistic that the data presented to the FDA from MIST will allow us to reach an agreement to appropriately modify MIST II.
Davis concluded, For the third quarter of 2006 and going forward, we continue to expect increased enforcement of HDE guidelines. We also expect to see our investments in Europe result in increased sales. As a result, we currently expect a 4%-6% increase in revenues compared with the third quarter of 2005. Looking ahead, with the anticipated modification of our MIST II study, anticipated European regulatory approval of BioSTAR, and further progression of our MIST III, CLOSURE I and BioTREK bioabsorbable implant programs, we continue to expect to accelerate spending from current levels. With that in mind, we currently anticipate ending 2006 with $30 million to $32 million in cash, cash equivalents and marketable securities.
This excerpt taken from the NMTI 8-K filed May 9, 2006.
Ahern said, The events of this past quarter have made us wiser and stronger as a company. The MIST trial has indicated that there is an unmet demand for alternative therapies for certain migraine sufferers. Working with the FDA, our clinicians and advisors, NMT will make the appropriate adjustments to our ongoing clinical trials to maintain our leadership position. Our sole focus as a medical device manufacturer is the PFO closure market. Going forward, we will continue to advance our technologies to best address this market opportunity.
Davis concluded, Due to the increasing awareness that we believe we are experiencing in both the U.S. and UK surrounding the benefits of PFO closure, we currently expect a 5%-8% increase in revenues in the second quarter of 2006 compared with the second quarter of 2005. We intend to use NMTs share of the settlement with AGA to accelerate our investments in our clinical trials, new technology initiatives and future sales and marketing programs. The settlement will provide the Company with an additional source of funds, allowing for more flexibility in spending and inventory management. We currently anticipate ending 2006 with $27 million to $30 million in cash, cash equivalents and marketable securities.
This excerpt taken from the NMTI 8-K filed Mar 7, 2006.
Ahern said, Clinical research continues to suggest there is an association between the PFO defect and the possibility for greater risk of migraine headaches, recurrent stroke and transient ischemic attacks (TIA). MIST data results are scheduled to be featured at the Late-Breaking Clinical Trials Sessions of the ACC and AAN. We currently expect to complete MIST II enrollment and anticipate receiving CE Mark approval for our BioSTAR implant by the end of 2006. We remain committed to being the first company to provide migraine and stroke patients with a proven, safe and effective PFO-related treatment option.
Davis concluded, We currently expect an 18%-20% increase in product sales in the first quarter of 2006 when compared with the first quarter of 2005. During the year, we plan to accelerate spending for our ongoing clinical trials and investments in next generation PFO closure technologies. We believe we have the available financial resources to meet the needs of our working capital, financing and capital expenditure requirements. As a result, we currently anticipate ending 2006 with $13 million to $15 million in cash, cash equivalents and marketable securities.
This excerpt taken from the NMTI 8-K filed Nov 2, 2005.
Ahern said, Momentum continues to build within the evolving PFO closure marketplace for the long-term potential of the migraine and stroke markets. As 2005 comes to a close and we move into 2006, we will seek to extend our leadership position within this emerging opportunity. We are building a substantial PFO closure technology pipeline that is leading the way in PFO closure discovery. With the recent announcement of approval to enroll patients in MIST III, NMT now has five PFO-related trials underway. MIST III is the Companys new study designed to expand data and follow-up on MIST migraine patients. We are not aware, at this time, of any other company with approval for more than one such study. In order to maintain our competitive advantage, NMT will continue to advance its technology pipeline by introducing novel new product enhancements such as BioSTAR. The ultimate winner in the PFO closure marketplace, whether it be for migraine, stroke or other brain attack indications, will be the company with the most advanced PFO closure technologies. NMT intends to be that technology leader.
Davis said, In the fourth quarter, we currently expect an approximate 20%-25% increase in product sales compared with the fourth quarter of 2004. For the full year 2005, we expect product sales to increase approximately 10%-12% and total revenues to increase approximately 10% compared with 2004. We anticipate that product costs as a percentage of product sales will be approximately 29%-30%.
Going forward, we continue to expect that acceleration of the MIST, MIST II and BEST studies, as well as our ongoing CLOSURE I enrollment, MIST III and investments in next generation PFO closure technologies, will demand high levels of research and development spending for the balance of 2005 and into 2006. Therefore, we currently expect our aggregate cash, cash equivalents and marketable securities balance at year-end 2005 to be approximately $29-$30 million, concluded Davis.
This excerpt taken from the NMTI 8-K filed Aug 4, 2005.
Ahern said, Going forward, NMT will continue to focus on expanding our leadership position in the evolving PFO closure marketplace. The positive preliminary results from the MIST study, along with the rapid rate of enrollment, strengthen our belief that migraine is a large growth opportunity for NMT. We continue to work with our regulatory and scientific advisors to develop the appropriate study design and protocol in order to meet our goal of obtaining an IDE approval for a MIST II PFO/migraine clinical study in the United States by the end of 2005. NMT will also continue to build its PFO closure technology pipeline to assure a sustainable competitive advantage in the future.
Davis concluded, In the third quarter of 2005, we currently expect an approximate 4%-6% increase in product sales compared to 2004. For the full year 2005, we continue to expect product sales to increase 3%-5% and total revenues to increase approximately 5%-7% compared with 2004. We continue to anticipate that product costs as a percentage of product sales will be approximately 30%. As previously discussed, acceleration of the MIST study, BEST study enrollment, ongoing CLOSURE I enrollment and investments in next generation PFO closure technologies are expected to result in continued high levels of research and development spending for the balance of 2005. However, we currently expect our aggregate cash, cash equivalents and marketable securities balances at year-end 2005 to be approximately $25-$27 million.
This excerpt taken from the NMTI 8-K filed May 11, 2005.
Ahern said, We continue to believe that migraine represents a substantial opportunity for NMT. We are very encouraged by the enthusiastic patient response to participate in the MIST study. It clearly suggests to us that current medical therapies do not meet the needs of certain severe migraine sufferers and that new methods of treatment are needed.
Our initial target population, migraine with aura patients with a PFO, may represent a 10% subset of the general migraine population. In the United States, that group would represent about three million potential patients. We are hopeful that MIST, the first prospective, double-blinded, randomized PFO/migraine study, can confirm what has been reported in several published observational studies - that migraine with aura patients have a high incidence of PFO and that closing the PFO with our minimally invasive technology can substantially reduce migraines in that patient population.
We are currently working with the FDA and our scientific advisors to determine the appropriate study design and protocol to initiate the MIST II PFO/migraine study in the United States. Joining the NMT Medical sponsored MIST II study as co-Principal Investigators are Stewart Tepper, MD, a neurologist and Director of the New England Center for Headache in Stamford, Connecticut, and Mark Reisman, MD, an interventional cardiologist and Director of Cardiovascular Research at Swedish Medical Center, Seattle, Washington. We currently expect to receive IDE approval for the study in the second half of 2005.
In the second quarter of 2005, we currently expect an approximate 10% increase in product revenue versus the first quarter of 2005. Based upon todays regulatory environment, we expect total year product revenue to increase 3%-5% and total revenue to increase approximately 5%-7% compared to 2004. We continue to anticipate that product costs as a percentage of product sales will be approximately 30%. Looking ahead, with the anticipated completion of MIST now ahead of plan and human trials of our next-generation BioSTAR bioresorbable implant nearing commencement, we currently expect to accelerate spending on these programs. As a result, we expect our cash, cash equivalents and marketable securities balance at year-end 2005 to be approximately $25 million, Davis concluded.
This excerpt taken from the NMTI 8-K filed Mar 1, 2005.
Ahern said, Ongoing medical research, including two articles in the most recent Journal of the American College of Cardiology, reinforces our belief that certain migraine patients will benefit from PFO closure. To that end, our focus in 2005 will be to continue the evaluation of the PFO/migraine connection. We currently expect to complete enrollment in the MIST study by the end of the third quarter, and hope to commence a U.S. migraine study in the second half of the year. We believe that PFO closure for migraine represents a substantial and more immediate revenue opportunity for NMT as compared to PFO closure for stroke. In addition to our migraine activities and the ongoing CLOSURE I clinical trial, we expect to initiate human studies of BioSTAR our next-generation, bio-resorbable implant technology in 2005 to further enhance our technology leadership in transcatheter PFO closure.
In the first quarter of 2005 we expect to show a slight increase in total revenue compared to the fourth quarter of 2004. This equates to an approximate 7%-9% decrease when compared to the first quarter of 2004. For the full year 2005 we currently expect that total revenue will increase 5%-7% compared to 2004, including modest product sales growth in North America and Europe, and a slight increase in net royalty income, Davis said. Given our CLOSURE I enrollment rate, stricter HDE enforcement and current inventory levels, we are scaling back our 2005 implant production rate. As a result, we expect our product costs as a percentage of product sales to increase to approximately 30% in 2005 compared with 26% in 2004.
Looking ahead, we continue to believe that our aggregate cash, cash equivalents and marketable securities will be sufficient to meet all of our working capital, financing and capital expenditure requirements beyond the completion of MIST, the completion of CLOSURE I, BioSTAR human studies and related submissions to the FDA. Based on our anticipated revenue and ongoing clinical activities, we currently expect to end 2005 with approximately $26-$27 million in cash, cash equivalents and marketable securities, Davis concluded.
EXCERPTS ON THIS PAGE: