Hal Hurwitz
Analyst · Jeb Terry of Aberdeen Investment Management. Please proceed with your question
Thank you, Frank. Before we begin, I want to point out that the comments made on this call may include statements that are forward-looking within the meaning of Securities Laws. These forward-looking statements may include without limitation statements related to anticipated industry trends, the company's plans, prospects, and strategies both preliminary and projected; and management's expectations, beliefs, estimates, or projections regarding future results of operations. Actual results or trends could differ materially. We undertake no obligation to revise forward-looking statements in light of new information or future events. For more information, please refer to the risk factors discussed in our Form 10-K for the year ended December 31, 2015, which have been filed with the SEC, as well as our quarterly report on Form 10-Q for the quarter and nine months ended September 30, 2016, that we will be filing with the SEC shortly. All our filings can be obtained from the SEC or by visiting our Web site at www.mriinterventions.com. Now, for our results from the 2016 third quarter, revenues were $1.6 million for the three months ended September 30, 2016, and $1.2 million for the same period in 2015, an increase of $370,000 or 30%, which was attributable to increases in both our ClearPoint system disposable and reusable products. ClearPoint disposable product sales for the three months ended, September 30, 2016, were $1.3 million compared with $970,000 for the same period in 2015, representing an increase of $309,000 or 32%. This increase was due primarily to an increased volume of procedures performed using our ClearPoint system within a larger install base for ClearPoint during the three months ended September 30, 2016 relative to the same period in 2015. ClearPoint reusable product sales for the three months ended September 30, 2016, were $309,000 compared with $239,000 for the same period in 2015, representing an increase of $70,000 or 29%. This increase was due primarily to differences in equipment configuration of ClearPoint systems sold during each of those three-month periods. Reusable products consists primarily of computer hardware and software bearing sales prices that are appreciably higher than those for disposable products, and historically have fluctuated, sometimes significantly from quarter to quarter. Gross margin on product revenues was 53% for the three months ended September 30, 2016, compared to 54% for the same period in 2015. The slight decrease in gross margin was due primarily to increases in the cost of disposable and reusable product components we purchased from third-party manufactures, and the allocation of indirect cost to manufacturing. These items were partially offset by an improvement in direct labor productivity, and a decrease in the cost of scrapped product. Research and development costs were $691,000 for the three months ended September 30, 2016, compared to $480,000 for the same period in 2015, an increase of $211,000 or 44%. The increase was due primarily to increases in compensation primarily related to an increase in headcount in January 2016, intellectual property costs allocated to research and development, and costs incurred in connection with or development of the next generation of the ClearPoint operating system. These increases were partially offset by an increase in the allocation of costs to manufacturing, and decreases in other product development costs and regulatory fees. Selling, general, and administrative expenses were $1.9 million for the three months ended September 30, 2016, as compared with $2.1 million for the same period in 2015, a decrease of $247,000 or 12%. This decrease was attributable primarily to decreases in personnel costs, which include share-based compensation and travel costs, professional fees, marketing costs, and medical device excise taxes, and an increase in the allocation of cost to manufacturing. These factors were partially offset by an increase in public company and investor relations costs. Our operating loss for the three months ended September 30, 2016 was $1.7 million as compared with $1.9 million for the same period in 2015, an improvement of $217,000 or 11%. Now I would like to briefly describe the non-operational items that affected our results during the third quarter. First, during the three months ended September 30, 2016, we recorded a non-cash gain of $324,000 related to additions to and changes in the fair value of derivative liabilities. In the same period for 2015, this gain was $2 million. In both the 2016 and 2015 periods these derivative liabilities related to the issuance of warrants in connection with 2012 and 2013 private placement transactions. In 2016 however derivative liabilities also include the affects of amendments we entered into in June and August, 2016, with certain note holders to add contingent conversion terms and potential down around pricing protection of warrants issued in connection with their notes. The note amendments we entered into in August 2016 provided for the ability of the note-holders to convert an aggregate of $1.75 million of their notes in the event we completed a private offering, and to reset the exercise price of warrants they received in connection with the original issuance of those notes to the exercised price established in the private offering. As I previously mentioned, execution of these amendments created derivative liabilities based on the new conversion feature and the new pricing of the warrants. The amendments also constituted debt extinguishments under generally accepted account principles necessitating us to record a non-cash loss from debt restructuring of approximately $933,000 during the three months ended September 30, 2016. This loss represents the aggregate difference in the fair value of those derivative liabilities between the points in time immediately preceding and immediately subsequent to the execution of the amendment. As Frank and I will discuss further, those note-holders did convert the notes pursuant to the August amendment in the pipe transaction we completed in September. Net interest expense for the three months ended September 30, 2016 was $240,000, compared with $314,000 for the same period in 2015. This decrease was due primarily to the reduced principal balance of the note payable to Brainlab AG resulting from the restructuring of that note in April, 2016. Reflecting the affects of these non-operational items, net loss for the three months ended September 30, 2016 was $2.6 million as compared with $245,000 for the same period in 2015. Now let's go over the financial results for the first nine months of 2016. Revenues were $4.1 million for the nine months ended September 30, 2016, and $3.1 million for the same period in 2015, an increase of $1 million or 33%, attributable primarily to increases in our ClearPoint system disposable and reusable products. ClearPoint disposable product sales for the nine months ended September 30, 2016 were $3.4 million compared with $2.5 million for the same period in 2015, representing an increase of $922,000 or 37%, substantially due to a greater volume of procedures performed using our ClearPoint system within a larger installed base for ClearPoint in the nine months ended September 30, 2016, relative to the same period in 2015. ClearPoint reusable product sales for the nine months ended September 30, 2016 were $610,000 compared with $469,000 of such sales in the same period in 2015, representing an increase of $141,000 or 30%. This increase was due primarily to a greater number of ClearPoint systems sold during the nine month period ended September 30, 2016 relative to the same period in 2015. As I previously mentioned, sales of our reusable products may vary, sometimes significantly, from period to period. Gross margin on product revenues was 51% for the nine months ended September 30, 2016, compared to 55% for the same period in 2015. The decrease in gross margin was due primarily to increases in the cost of disposable and reusable product components we purchased from third-party manufacturers, production scrap, and the write-off of expired product, and the allocation of indirect cost to manufacturing. These increases were partially offset by decreases in production variances, inventory adjustments, and the provision for excess and obsolete inventory. Research and development costs were $1.1 million for the nine months ended September 30, 2016, compared to $1.4 million for the same period in 2015, an increase of $664,000 or 46%. Similar to the third quarter increases I described, this year-over-year nine-month increase was due primarily to increases in software development costs, personnel costs, and intellectual property costs allocated to research and development. These increases were partially offset by an increase in the allocation of departmental costs to manufacturing. Selling, general, and administrative expenses were $5.7 million for the nine months ended September 30, 2016, as compared with $6.6 million for the same period in 2015, a decrease of $860,000 or 13%. This decrease was attributable primarily to decreases in personnel costs, including share-based compensation and travel, medical device excise taxes, professional fees, marketing costs, and occupancy costs. These decreases were partially offset by an increase in public company costs. Affecting the nine months 2015 results was the closure of our former Memphis, Tennessee headquarters, as we focus all operations in our Irvine, California facility. We did not retain any of our seven Memphis-based employees, which included three of our executives. As a result, we incurred expense of $1.3 million primarily related to termination costs, including the modification of option terms during the nine months ended September 30, 2015. Our operating loss for the nine months ended September 30, 2016 was $5.7 million as compared with $7.6 million for the same period in 2015, an improvement of $1.9 million or 25%. Now for a brief discussion of non-operating items impacting the nine-month results, during the nine months ended September 30, 2016 and 2015, we recorded non-cash gains of $748,000 and $981,000 respectively, resulting from additions to and changes in the fair value of derivative liabilities that I described in my discussion of the three-month results. As we described in our discussion in our 2016 second quarter results, in April 2016, we significantly restructured the note we had payable to Brainlab. In this restructuring we were able to negotiate a $2.3 million reduction of the previously existing $4.3 million note by entering into a patent and technology license agreement for software relating to our SmartFrame device, and issuing equity units to Brainlab, each unit consisting of shares of our common stock and warrants. In connection with this restricting we recorded a gain of $941,000, representing the difference between the aggregate fair value of the license agreement and the equity units versus the aggregate principal amount of the Brainlab note cancel this consideration. Also as discussed last quarter, on June 30, 2016, we entered into amendments with Brainlab and two holders of our 2014 secured notes payable. Pursuant to the amendment, the parties agreed that in the event we would've have closed the qualified public offering, $2 million of the principal balance of those notes, plus all unpaid accrued interest on that amount would've automatically converted into the security offered in the qualified public offering. And the exercise price for warrants issued in connection with those notes would've been reduced. Based on these provisions on June 30, 2016, we recorded a non-cash debt restructuring loss of $820,000, resulting from the restricting of the Brainlab note and those 2014 secured notes. As I described in my discussion of the Q3 2016 results, on August 31, 2016 we ended into second amendments with the same two holders of the 2014 secured notes. These second amendments provided for similar conversion and warrant provisions as the first amendment, but this time allowed for note conversions in the event we closed a private equity offering, which as we have previously announced, we did close on September 2, 2016. As mentioned in my discussion of the Q3 2016 results, execution of these second amendments constituted a debt extinguishment under generally accepted accounting principles, necessitating us to record a non-cash loss on debt restructuring of approximately $933,000, representing the aggregate difference in the fair value of the derivative liabilities between the points in time immediately preceding and immediately subsequent to the execution of those second amendments. Net interest expense was $836,000 and $921,000 for the nine months ended September 30, 2016 and 2015 respectively. The decrease was due primarily to the reduced principal balance of the note payable to Brainlab resulting from the Brainlab note restricting I previously described. Reflecting the affects of these non-operational items, net loss for the nine months ended September 30, 2016 was $6.4 million as compared with $7.3 million for the same period in 2015. So with that, I will now turn the call back over to Frank.