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CC Part 1
Dr. George CEO
Thank you for joining us on today’s call. The past quarter was one of accomplishments and change for Calypte. We continue to move our products through the regulatory processes and closer to launch. Yesterday we announced the approval of our Rapid HIV Test in Uganda and this morning we announced the completion of our trials and preliminary results out of China. We also initiated a major restructuring plan to discontinue older product lines and minimize expenses with the intent of maximizing cash resources and enhancing profitability upon launch of our Rapid HIV Testing Platform. A few weeks ago we announced the signing of a letter of intent with Maxim Biotech to explore the sale of our Legacy Products; our Urine EIA and our two Western Blots. Maxim and Calypte have since signed a manufacturing service agreement and are moving forward to complete the sale of our Legacy line of products. If and when the definitive agreement is fully executed Maxim would also assume the Rockville Manufacturing Facility lease and associated Intellectual Property and equipment lease obligations. Rick Brounstien will provide you a more detailed status report on this transaction as part of his review of the quarterly results then I will come back and take you through a review of operations. Rick…
Rick Brounstien CFO
Thanks Richard, and welcome to the Calypte update for the quarter ended March 31st 2005. Revenues for the first quarter of 2005 decreased 32% or $306,000 to $665,000 compared with $971,000 for the first quarter of 2004. While the differences have a lot to do with the consolidation of manufacturing from Alameda into Rockville, going forward we anticipate Rockville to operate at a zero dollar burn rate to Calypte. Of our current and ongoing products the HIV 1 BED Incidence Test is on the market and our HIV Rapid Products are close to generating revenue as the launch into Africa and China draws near. Effective May 1st the three other products which we referred to our Legacy Products; the Urine EIA, the Urine Western Blot Supplemental Test and the Blood Western Blot Supplemental Test will be manufactured by Maxim Biomedical. Initially Maxim will produce product for Calypte on a contract manufacturing basis when we expect to complete the necessary approvals and ultimately transfer the business to them subject to a definitive agreement. While there is interests by both parties in Maxim acquiring the business, today what we have is an outsourced manufacturing agreement and a letter of interest from Maxim to complete an acquisition. Affectively the current Legacy sales will continue for Calypte’s account at least into June of this year. And I would expect the second quarter run rate to be similar to Q1 of 05.
Rick Brounstien :
All of the insurance labs purchased at least once during the first quarter and this business appears to be returning to historical levels. We’ve completed the technology transfer of the Urine EIA Test to Rockville and filed our submission with the FDA. Maxim is continuing with our plan and is preparing to build the Urine EIA inventory at Rockville to maintain the products availability as the transition from Alameda to Rockville completes as planed. We expect the momentum for the BED Incidence Test during 2005 and beyond to grow stronger as the CDC continues to conduct its workshops to train the trainers on the application and use of the test. While still modest sales increased 26% from last year quarter Q4 of 04 to $39,000 in Q1, of 05 and we expect this trend to accelerate. While the product is available for sale it would not be reasonable to consider the Incidence Test fully launched until all the workshops are complete. We are currently at a run rate of less than 100,000 tests per year. However, the ongoing expectation from the CDC is that demand will grow to 2 to 5 million tests annually over the next couple years. We see this expanding interest resulting from the CDC’s endorsement of this product as the key surveillance tool in the fight against AIDS. Cost of Goods Sold was $1,500,000 in the first quarter of 2005, a decrease of 23% or $460,000 from almost $2,000,000 in the first quarter of 2004. In many ways the numbers are just not comparable, only about $50,000 is related to lower or variable costs on lower sales. Otherwise, in 2004 we were running Alameda, California in preparation to consolidate the Urine EIA product in Rockville, which has now been completed. Elimination of Alameda rents overheads and personnel saved the Company over $250,000 between quarters
Rick Brounstien :
However, our plan to build Urine EIA in Rockville was in transition in Q1, 05 and we are not yet absorbing the overhead with Urine EIA manufacturing in Rockville. Also, as a result of the manufacturing relocation almost half of the cost of goods in Q1, 05 is inventory adjustments as we finalize the transition. As we implement the restructuring we have cut Rockville manufacturing head count by over 50% reducing the facility to approximately a break-even at today’s revenue levels. As a result of the manufacturing services agreement with Maxim, they have an arrangement that locks in a zero dollar burn rate on our Legacy Products, with the potential for upside, assuming they complete the acquisition. The Company will incur one time costs related to the restructuring in Q2, 05 as we transfer our inventory to Maxim to facilitate production and sales under the manufacturing services agreement. Thereafter, we expect to be fully outsourced and if so our second half revenues result immediately in positive growth margins. R&D expense increased 41% or $221,000 to $762,000 in Q1, 05 from $541,000 in Q1, 04 the primary drivers of the increased R&D are - First, increased clinical testing – Second, higher travel costs to support the launch of the Rapid Platform Technology in Thailand and China and – Third, increase technical consulting time to support the Ani Technology Platform. SG&A costs decreased by $782,000 or 36% to $1,414,000 in the first quarter of 2005 compared to SG&A costs of $2,196,000 in the first quarter of 2004. There are a couple of large components that netted this decrease; most of the decrease is in salary expense. Last year we transitioned CEO’s to Richard and did not re-hire his VP of Government Affairs position, we also eliminated the role of Executive Chairman. Legal and auditing came down by approximately $100,000 as we completed a change of auditors a year ago.
Rick Brounstien :
We have now re-qualified to use short form SEC filings such as a registration statement using SEC Form S3. The loss from operations dropped by over $700,000 and this is reflected in a reduced burn-rate which was about $800,000 a month in this first quarter of 2005 versus a steady $1,100,000 a month last year in 2004.
And with the restructuring expected to be completed largely during this second quarter of 2005 we expect to realize additional significant reductions in second half of 2005. As I noted above we’ve already cut manufacturing payroll by over 50% as of the end of April. Net interest and other expense are primarily non-cash. The first quarter 2005 cost of $260,000 approximated Q1 of 04 was a primary component being approximately a $200,000 Mark-to-Market charge valuing the change in the counting value in the Anti-Dilution provision of the stock issued in the May and July 2004 PIPE transactions based on a Binomial Valuation model following the guidelines for FAS 150 and the related EITF issues. This is part of a $1,800,000 anti-dilution obligation which has been classified as a current liability on the balance sheet. If we issue the shares to fulfill the anti-dilution provision based on an affirmative vote by our stockholders at the scheduled June 30th annual meeting we would re-classify the $1,800,000 to equity. Cash at March 31st in the Balance Sheet does not reflect the closing of this early April 2005 financing. We exited April with approximately $4,500,000 in cash. The 2005 Credit Facility also provides us, subject to certain requirements, with a $5,500,000 borrowing capacity. Following the restructuring we have an operating burn rate that together with our financial resources expect it to allow us to achieve our milestones effectively through the end of the year. Id like to now turn the call back over to Richard.
Dr. George :
Review of Operations
Thank you Rick, now I’d like to review operations. At long last we were especially pleased to announce this morning that the clinical trial in the Peoples Republic of China has been successfully completed. A preliminary report for the Oral Fluid and Urine HIV 1 – 2 assays has been completed by the Chinese Centers for Disease Control and Prevention. The trials conducted by the Chinese CDC involved approximately 1500 subjects composed of HIV positive, HIV negative and subjects with other viral diseases. The results were truly outstanding and the consistent performance by our Rapid Tests remains encouraging. The accuracy of the Urine and Oral Fluid HIV 1-2 Rapid Test was established by comparison to results from Enzyme Immunoassays of Western Blot Assays already approved already approved by the Chinese SFDA. In this study concordance of the EIA Testing to the Oral Fluid HIV 1-2 Rapid Test was 99.9% and over 99.5% for the Urine HIV 1-2 Rapid Test. The very strong performance of our assays in this study conducted by this prestigious Chinese public health institution provides additional strong validation of our technology. The Calypte HIV 1-2 Blood Rapid Test and our Urine and Blood HIV 1 Western Blot assays were also evaluated as part of this trial but the reports on their performance were not available in time for this Conference Call. We will provide this information as it becomes available over the coming weeks. We will immediately prepare our application for review by the Chinese State Food and Drug Administration. We expect to submit that application to the SFDA in the current quarter and remain confident that that application will receive the prompt attention of the Chinese SFDA. Approval is expected to come in late summer or early fall of 2005. While we’re waiting for the SFDA approval we will be completing manufacturing provisions in China. To that end we are actively recruiting personnel in the areas of quality assurance, quality control, regulatory and manufacturing. We have been notified by Ani Biotech that our automated equipment is ready for shipment to China. A team from Calypte is going to Ani’s facility in Finland for training on the use of this equipment in June and our plans call for the equipment to be installed in our plant in China and for that plant to be ready to service the Chinese market as soon as the SFDA approvals are received.
Dr. George :
Progress around the World
While we are very excited about progress in China great strides are being taken in other parts of the world. Yesterday we announced the completion of the regulatory process in Uganda and the first approval of our Rapid Test Products. In addition we have started studies in South Africa. Testing of the Blood Rapid Test has been completed and the testing of the Oral Fluid and Urine is scheduled to begin in late June or early July. Testing in Kenya is set to begin in June. Testing in Cameroon and Botswana is ready to go in late summer. Clinical studies have already begun in Vietnam. In addition to China, Vietnam and Africa we are set to begin the regulatory process in India. As we speak Dick Van Maanen our Vice President for Operations is in India working with our distributor to begin those studies. India has the second largest number of cases of HIV infection and the second largest population of any country in the world. We are very confident that our Rapid assays as well as our Incidence products will play a significant role in India’s effort to curb the spread of HIV among its population.
Dr. George :
BED Incidence Test
I would like to discuss the progress of the BED Incidence Test. This assay was rapidly put into production at the end of last year and our first shipments occurred in October of 2004. Sales of this product currently are modest, the sales are growing and the train the trainers workshops continue and we expect this ramping up to continue through 2005 and 2006 until they reach levels of approximately 5,000,000 tests per year in 2007. This assay was originally projected to be a surveillance tool and not used for clinical purposes. Now there are increasing amounts of data suggesting that there is in fact significant clinical benefit in identifying those infections that were recently acquired. Individuals with acute infections have high viremia and are in high risk for transmitting the disease. When these patients are put on early therapy, the viremia is reduced and the course of disease in these people is usually much milder than when treatment is instituted later in the course of the disease. Calypte has been advised by both the CDC and the FDA that an IDE application for use of this test for clinical purposes would be welcomed. Our first meeting with the FDA in pursuit of this claim takes place in July. We believe that the expansion of the use of the BED Incidence Test and innovative new products, such as the Rapid Diagnostic Incidence Test being developed in cooperation with the CDC will be an important product line for Calypte.
Dr. George :
Progress Summary
I am very excited the progress we have made since my last report to you. It is difficult to always be absolutely accurate when predicting the time in which these complicated tasks will be completed. But we continue to execute our plan to develop these innovative new products and get them to the market place as quickly as possible. That plan validates our technology, the plan that obtains regulatory approval, a plan that establishes manufacturing and a plan that later this year begins sales of our Rapid Tests. Since I became President, CEO in January of 2004 I have been diligently rebuilding the Company and trying to focus our attention and resources on the least resistant path to revenue and profitability through our current product line. In evaluating this path it became clear that each product line the Company possesses had its own set of challenges. In January of 2004 the Rapid Test had great promise but very little clinical data. No large scale or repetitive scientific validation, incomplete and restrictive IP issues and no regulatory strategy. Since then we have firmly and diligently addressed these critical elements by validating the technology in three independent clinical trials involving almost 3,000 subjects. Acquiring all the necessary IP licenses and firmly entering the regulatory process in China and in Africa. On the other end of our line of the Legacy Line of products were FDA approved and established in the market place
Dr. George :
Our EIA and Western Blot Product lines are strong diagnostic tools with reliable customers that focus on a distinct opportunity in the HIV market. However, going forward we see considerable near term international growth opportunities in the Rapid HIV and BED Incidence Testing markets. Our decision to restructure is in keeping with our objective to distribute our resources toward our future - the Rapid HIV Testing Platform and the BED Incidence Test. As a Company that is spending heavily on Intellectual Property, on regulatory pursuits, manufacturing facilities and product launches I need to focus our resources on what we believe to be the greatest opportunity – our Rapid Test. To this end we have entered into a contract manufacturing agreement with Maxim Biomedical and we currently are expected to conclude a definitive agreement to complete the sale of our Legacy business. In addition to the Rockville restructuring later this summer we also plan to close the administrative offices located in Pleasanton, California and re-locate those activities to Lake Oswego, Oregon. Lake Oswego is a suburb of Portland. This location was selected to consolidate all of our US activities into one location. Our main R&D location was already in this area. When I came to Calypte we operating manufacturing facilities in California and Maryland; R&D was located in Maryland and Vancouver Washington. It was extremely expensive and very difficult to efficiently oversee these scattered operations. Whilst the restructuring is completed our US operation will be reduced to approximately 15 to 20 people located in the same city. And our burn rate will be reduced from $1,100,000 per month level of 2004 to approximately $500,000 per month. I anticipate staffing the US to remain at this level for the foreseeable future and anticipate near term personnel and expenditure growth to come out our Beijing, China site. This restructuring will clear the decks to permit the Company to focus its attention and resources on what we believe to be the future of the Company. Sixteen months after my appointment as CEO Calypte is a much different Company. We have completed the development of three important new Rapid HIV 1-2 assays. One for use with urine samples, one for use with oral fluid samples and one for use with blood samples; these assays have been fully validated. We have acquired all the licenses required to sell these products world wide. We have established manufacturing in Thailand. For the past six months Calypte has been conducting clinical studies in several countries in pursuit of regulatory clearances. We are also please to announce the receipt of the first letter from Uganda clearing the way for sales of Aware® HIV 1-2 Rapid Test for use with blood, oral fluid and urine. Our progress this reporting period has been remarkable. We are a very different Company from what we were in January of 2004. We have streamlined our operations, dramatically cut our costs and we are focused on those activities that will create revenue and move the Company forward. All of us here at Calypte look forward to the rest of 2005. Now I’d like to open this up for questions so operator, please go ahead.
by Sower
Gruß
C.O |
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