diedicar
Utente Registrato
- Registrato
- 8/8/05
- Messaggi
- 3.477
- Punti reazioni
- 71
I will begin with a review of our second quarter 2010 results and then turn the call over the our President and Chief Executive Officer, Frank Martin. For the three months ended June 30, 2010 NMT reported total revenues of approximately $2.6 million compared with $3.2 million in the second quarter of 2009. Cardiac septal repair implant in North America in the second quarter of 2010 were approximately $1.9 million compared with $2.4 million in the second quarter of 2009 Implant sales for the second quarter of 2010 outside of North America which includes countries in Western Europe and the rest of world were approximately $700,000 compared with $800,000 in the corresponding period of 2009.
se credi nel titolo perchè prenderlo quasi un 10% più inalto???
guarda io non pompo niente ma qua c'è un errore grossolano...
questi fatturano 2,5/3,5 mln di $ a trimestre e hanno pipeline... hanno ancora cash e forse un trial (che ha causato il crollo delle quotazioni) da riprendere sotto approvazione fda... poi non hanno niente di meno di crdc che quota oltre 2$, ha solo pipeline nessuna revenues...
interessante, però hanno cash per 1 trimestre/1trimestre e mezzo, molto interessante comunque
io ho incrementato la mia posizione perchè con 16mln di azioni circolanti prefersico essere dentro...
Our sale this quarter reflect a shortfall to expectations in some of our larger European markets including the UK and Germany. In general we have experienced an increase in competition in some non US markets. That competition is from foreign manufacturers that despite our technological advantages and benefits are able to price their products lower than NMT. Over the past several quarters we have implemented a strategy to help boost unit sales of BioSTAR by developing new distribution partnerships.
This strategy has worked better in some markets than in others, for examples we now believe that a more direct sales strategy especially in Germany similar to the one we have in place in the UK offers us the best potential for improving European implant unit sales. In addition, as we noted in today’s press release, we believe the anticipation in the medical community for the result of CLOSURE I may have temporarily slowed the referral pattern of patients both in the United States and abroad.
Our cost of product sales on a percentage basis in the second quarter of 2010 was approximately 54% compared with 45% in the second quarter in 2009. The increase is due to the impact of our fixed manufacturing expenses and royalty expenses on the lower sales volumes. Q2 2010 R&D expenses were reduced by $1.8 million or approximately 71% of total revenue compared with $2.4 million or approximately 76% of total revenue in the same quarter of 2009. We expect R&D expenses in 2010 will continue to be lower than 2009 primarily due to the reduced cost associated with the CLOSURE I trial.
General and administrative expenses were approximately $2 million or 79% of total revenues in the second quarter of 2010, compared with $1.7 million or 53% of total revenues in the same quarter of the prior year. Last year’s Q2 expenses were reduced by the receipt of $375,000 as part of the settlement that was negotiated with Cardia Inc. Second quarter selling and marketing expenses were approximately $1.3 million or 50% of total revenues compared with $1.5 million or 48% of revenues for the same period in 2009.
Our sales and marketing expenses on a dollar basis were lower year-over-year primarily as a result of our sales levels. In February 2010, we executed a private placement of our common stock with warrants to purchase approximately $2.1 million additional shares. The warrants will recorded at fair market value and are revalued each reporting period using the Black-Scholes method. We recorded a non-cash gain of $6.4 million in the second quarter due to the decrease in our stock price during that period.
Our pretax non-cash charge gain will continue to be recorded each quarter through February 2015, it may vary significantly based upon fluctuations on our stock price in each reporting period. We also incurred a loss of approximately $24,000 due to currency translations during the quarter compared with the gain of $24,000 in the second quarter of last year. This was the result of the strengthening of the US dollar.
Looking at the bottom line, we reported net income including the $6.4 million pretax benefit related to the aforementioned warrants of approximately $2.6 million or $0.16 per diluted share compared with a net loss of $3.8 million or $0.29 per share for the same period of 2009. Because of the large benefit related to the warrants, we believe our operating performance is a more meaningful indicator. For the second quarter of 2010, we reported a loss from operations of approximately $4 million compared with a loss of $3.9 million in the same period of 2009.
During this time of transition, it is important for us to manage our expenses efficiently to manage our operating loss and preserve cash to fund the future programs. At June 30, 2010 our cash, cash equivalence and marketable securities were approximately $6.5 million. We also have the previously announced credit facility. Last few months have been challenging for NMT. While we have done an excellent job reducing expenses, our near term sales results had been below our expectation, placing additional pressure on our capital resources. We expect to attempt to raise additional capital over the next several weeks in order to continue to support our ongoing efforts.
Turning to our sales, we currently expect Q3 sales to be approximately $2.5 million similar to Q2. Our primary focus is our CLOSURE I and are discussions with the FDA. Once the appropriate course of actions has been determined, we intent to update our stakeholders.
And with that I’ll turn the call over to Frank Martin. Frank?
Frank Martin
Thank you Rick for the review, good morning to all. I’d like to open my remarks with a discussion of the primarily results of our pivotal PFO-TIA clinical trial, CLOSURE I which we announced in mid June.
First, we have received inquiries as to why we announced the preliminary results ahead of scheduled completion of the data analysis in the fall and before we had determined next steps with the FDA. As a small publicly traded company, we are required to announce material information that may affect the company’s stock price. And as soon as the initial top level sales and have level of data analysis was known indicating that the trial did not meet its primary endpoint, even though the data analysis was not fully complete, we had no choice and we’re advised to publicly announce the preliminary findings from the trail.
The preliminary results confirm several positive attributes of our technology. Most importantly they indicate that CLOSURE with STARFlex provides a small but not significant – statistically significant benefit over current best medical therapy. At the same time the safety profile of the STARFlex device is very good. The preliminary results also demonstrate a low rate of complications during the trial including only limited occurrences of thrombus formation. Closure rates after independent core lab adjudication in the trial are 86.5% which is consistent with NMT’s previously reported results for STARFlex and inline with competitive trans catheter closure devices.
However, none of the previously reported closure rates have competitive septal repair devices were validated by an independent core lab, and therefore may not be conclusive of device performance. The closure rate reported in the CLOSURE I trial is the first evaluation of a large cohort of randomized patients, where the results were reviewed and adjudicated by an independent core lab, that’s an important takeaway. So what does this mean for NMT or the patients treated with our products. we received a clinical data report that contains comprehensive details from the participating sites and the core labs.
This report which analysis both primary and secondary endpoint is currently being categorized, summarized and prepared for presentation. We will not have the entire patient data set available until sometime in the late October and so the complete CLOSURE I presentation is scheduled for the American Heart Association during mid November in Chicago.
This presentation date has been planned for several months and is been disclosed previously. Our abstract is already been submitted, w expect it to be accepted today or tomorrow to the FDA, to the AHA, excuse me, for its late break trial sessions. In the meantime, we are discussing our next steps relating to the stroke TIA indication with the FDA.
In addition we’re working with our clinical investigators, contract research organization, the CLOSURE I executive committee, our scientific advisory board to analyze the trial data to help us better understand and evaluate our clinical and regulatory options. Shortly we expect to arrive at a promising alternative to our original plan. At this time however, it would be premature for us to discuss these options. We plan to update our stakeholders on that strategy once we’ve completed further discussions with all of these parties including the FDA.
We remain confident in the benefits of septal heart repair through PFO treatment. We intend to continue to raise awareness about our clinical efforts in upcoming medical conferences and through various industry publications and our usual sales and marketing efforts. For example, our paper on the methodology of the CLOSURE I, the trial has been accepted by the editors of the journal Stroke and will be published sometime in the next several weeks.
While the completion of CLOSURE I remains a primary focus for us, we have several other notable development programs underway, On the heels of BioSTAR’s successes, the first bioabsorbable implant in the market, we develop the next generation biological implants BioTREK, which is currently in the preclinical stage. BioTREK is a most advanced implant design developed and is representative of the future devices for PFO treatment and will continue to bolster our position as the clinical and technical leader in the treatment of structural heart disease.
Now just to shed some light on how biological devices are shaping the future of PFO treatment, a recent study conducted in Canada which published its finding in the July issue of catheterization and cardiovascular interventions treated 10 children using our BioSTAR device for atrial septal defect occlusions. The BioSTAR device successfully closed 90% of small to moderate size congenital atrial septal defects within 24 hours and closure rates at six months in these children were 100%.
In addition I should remind everyone, the results of CLOSURE I have had and we expect no impact on the status of our current FDA and CE Mark approvals for VSD and atrial level shunt patients. Our STARFlex device is approved in the US for treatment of VSD patients, in patients who are not candidates of surgical closure. It is also available in the US via CARS, excuse me, or Closure After Recurrent Stroke and IDE as well as in Europe commercially under the CE mark.
And so now let me briefly to some recent developments in the last quarter. In May – back in May at Euro PCR, we launched to breakthrough in our septal implant delivery products, the RT 2 delivery system, which is pre-attached to our BioSTAR and STARFlex implants. The RT 2 delivery system provides increase in use. It’s a single operator delivery system, its already attached and requires minimal repositioning. The RT 2 delivery system is currently available in France and we expect to launch the system in countries throughout Europe over the next several months.
We strengthened in this quarter, we strengthened our Board of Directors with the addition of Paul Kramer, a recognized leader in the diagnosis and treatment of structural heart disease. Dr. Kramer brings the unique perspective to our Board regarding the potential for all percutaneous cardiovascular interventions. I also want to thank Mrs. Cheryl Clarkson who recently left our board after serving as a valuable and trusted advisor for the past nine years.
So in closing, I’d like to reiterate that we are committed to updating our stakeholders on our strategy for the stroke TIA indication once it’s been established through our discussions with the FDA and the clinical investigators, CRO, and the executive committee. In the meantime, there is really no more additional information we can provide regarding CLOSURE I data.
