Albany Molecular Research, Inc. (NASDAQ:AMRI)
Q4 2007 Earnings Call
February 11, 2008 10:00 am ET
Dr. Thomas D'Ambra - Chairman, President and Chief Executive Officer
Mark Frost - Chief Financial Officer
Amy Stevens - Susquehanna Financial Group
Please standby we are about to begin. Good day everyone, and welcome to the Albany Molecular Research Inc. Fourth Quarter 2007 Earnings Release. As a reminder, today's conference is being recorded. For opening remarks and introductions I will now turn the call over to Dr Thomas D'Ambra Chairman, President and Chief Executive Officer. Please go ahead sir.
Dr. Thomas D'Ambra - Chairman, President and Chief Executive Officer
Thank you, Nicky. Good morning ladies and gentlemen, welcome to the conference call segment of AMRI’s Fourth Quarter 2007 Earnings Announcement. This call is a follow-up to AMRI’s press release that was issued earlier this morning on Business Wire.
With me is Mark Frost, AMRI’s Chief Financial Officer. I am going to turn the call over to Mark for his discussion of financial results and guidance after which I will make additional comments. Mark?
Mark Frost - Chief Financial Officer
Thank you, Tom. Before we begin I would like to note that much of our discussion today might be term forward-looking other than historical facts or statements may contain projections, estimates and other forward-looking statements that involve a number of risk and uncertainties including those discussed in the company’s annual report on Form 10-K for the year–ended December 31, 2006 as filed with the Securities and Exchange Commission on March 15, 2007 and the Company’s other SEC Filings.
While these statements represent managements current judgment on the future direction of the company’s business. Such risks and uncertainties could cause actual results to differ material from any future performance suggested herein. The company undertakes no obligation released publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date here.
I am now going to present financial results for the fourth quarter along with guidance for 2008. Further details are included in our press release issued earlier today over Business Wire. Key highlights for the quarter and year and other recent events include over 20% contract revenue growth and our development small scale business segment for the fourth quarter for the fourth quarter 26% for the full year.
Full year adjusted operating income increased over 100% to $11.6 million from $5.7 million in 2006. Full year adjusted net income of $9.1 million for 2007, up from $6.5 million in 2006.
Operational cash flow improved by 20 million to 31.7 million. An increase in customer compound and clinical trials that are underdevelopment of our labs from 40 to over 50.
Our Phase III compound portfolio did not change from the current 16 compounds, however, we did experience some churns as two customer compounds failed in late stage clinical trials offset by the addition of two new Phase II customer compounds.
Our board has authorized a $20 million stock buyback plan. Tom will provide more contexts on this program a little later.
Turning to financial results for the fourth quarter of 2007. All comparisons are on a year-over-year basis. Total revenue was 47.2 million, an increase of 1% compared to 46.6 million in 2006. Total contract and milestone revenue was 41.1 million, an increase of 2% compared to 40.3 million in 2006.
Total contract revenue was 40.6 million, an increase of 1% compared to total contract revenue of 40.3 million in 2006. Total contract revenue encompasses revenue from AMRI’s discovery services, development small scale manufacturing and large scale manufacturing business components.
Contract revenue from development small scale manufacturing was 11.4 million an increase of 22% compared to 9.3 million in 2006. The strong performance was driven by continued demand for development of analytical services from emerging pharma and biotech customers in the United States.
Contract revenue from discovery services was 11.5 million, a decrease of 6% from 12.2 million in 2006. Performance was mixed in this component as double digit growth in both the US and Singapore medicinal chemistry was offset by difficult quarter in Europe. Contract revenue from large scale manufacturing was 17.7 million, a decrease of 6% compared to 18.8 million in 2006.
As communicated in our press release on January 29, delays in the shipment of certain customer deliverables with the primary driver for our decrease in large scale contract revenue. Delays were caused weekly by an external logistics problem, as well as internal execution on development projects.
Recurring royalties from Allegra(NYSE:R) was 6.1 million, a decrease of 4% from 2006. In the absence of a potential generic at-risk launch of Allegra D, we expect this trend to continue. We are not aware of any definitive plans for generic at-risk launch at this point in time.
As a result of the decrease in taxable income at certain of our international locations, our tax rate was negatively impacted in the fourth quarter by approximately $0.2 in earnings per share.
Net loss was 0.9 million or $0.3 per diluted share, compared to a net loss of 0.8 million or $0.2 per diluted share in 2006. On a Pro forma we are down $0.8 from prior year primarily because of global large scale margins as well as the unfavorable tax rate. Tax generation despite the loss in the fourth quarter was 8.2 million reflecting stronger balance sheet management.
I'm going to turn to full year, year-to-date results. Total revenue was 192.5 million, an increase of 7% compared to 179.8 million in 2006. Total contract and milestone revenue was 165.5 million, an increase of 8% compared to the prior year. Total contract revenue was 163.4 million, an increase of 7% compared to 152.8 million in 2006.
Contract revenue for Development and Small Scale Manufacturing was 45.4 million, an increase of 26% from 36.2 million in 2006. This was our third year in a row with mid 20% growth in this component.
Contract revenue for discovery services was 41.6 million, an increase of 5% from 39.6 million in 2006. When you include the milestone revenue from our strategic discovery offering, total revenue was up 10% in this component.
Contract revenue for large scale manufacturing was 76.3 million, a decrease of 1% compared to 77 million in 2006. Milestone revenue resulting mainly from our licensing agreement with Bristol-Myers Squibb was 2.1 million.
Recurring royalties from Allegra for 2007 were 27.1 million, up slightly from 27 million in 2006. Net income under US GAAP was 8.9 million or $0.27 per diluted share compared to net income of 2.2 million or $0.07 per diluted share in 2006.
Net income for 2006 on adjusted basis was 6.5 million or $0.20 per diluted share when you exclude the charges related to the sale of our former Mount Prospect Research Center and the large scale restructuring.
Net income in 2007 on an adjusted basis was 9.1 million or $0.28 per diluted share when you exclude large scale manufacturing restructuring charges of 177,000. This is a 40% improvement in earnings from the previous year. This was driven by our contract services business both fee for services and strategic technologies.
For the full year 2007, we generated approximately 32 million in cash from operations which is up significantly from our prior year results of $11 million.
I'm now going to transition to a discussion on our margins for the full year 2007. Overall gross margin on our contract services business was 19% in 2007 compared to 16% in 2006.
Our US large scale manufacturing business drove the overall margin improvement where margins increased to 11% up from 3% last year. Startup integration cost related to our Indian manufacturing acquisition dropped the overall large scale margin to 10% for the year.
In our discovery and development segments, gross margin for the full year 2007 decreased to 28% from 29% in 2006. The build-out of our International service offering caused the decreases. Our fixed cost flow went up. We've still not reached critical mass on our revenue strengths.
International lab margins were 4% drag on full year margins. Margins in our US lab business were up from 2006 levels driven by demand for development and small scale services.
Earnings Before Interest, Taxes, Depreciation and Amortization EBITDA in 2007 was 28.6 million or 15% of total revenue, a 35% increase from 2006. Even in 2007 for just the contract services business excluding milestones, royalty revenue, and R&D expenses was 13.6 million or an 8% return on contract revenue a 96% increase from 2006.
Now I'm going to turn to financial guidance for 2008. Due to the stability we've seen in our royalty revenues over the past several quarters, we're reintroducing earnings per share guidance. But first let me run through our contract revenue guidance. For the full year 2008 we estimate contract revenue to range from a 178 to 182 million, an increase of up to 12% from 2007.
To get to the range of 178 to 182 million, we project discovery services revenue to range from 53 to 55 million, an increase of 27% to 32% over 2007s level. We expect increased demand for our medicinal chemistry services both in the US and Asia as well as strong natural products and screen revenue from contracts which we signed in 2007.
We anticipate development and small scale revenue to range from 49 to 50 million, an increase of 8% to 10% from 2006. As indicated earlier, we've had three years of 20% plus growth, so we're being cautious in due with the larger prior year number and hope this is a conservative forecast.
We project large scale revenue to range from 76 to 77 million an increase of up to 1% over last year. There are number of reasons for our flat forecast. The first two are regulatory in nature. Tom will provide more color on the first issue which has been a restriction by DEA on our ability to produce shift, certain controlled substance products, because of the lack of the quality.
The other regulatory issue relates to the FDA and the slowdown in product approvals. We continue to have a robust Phase III pipeline, but its taking longer for our customers to move to commercial decisions points. The third reason for flat revenue relates to other legacy commercial products where reorders can happen every two years. We are anticipating some products will not be reordered in 2008, which will drop $5 million from our revenue. The impact of this will be felt in our first quarter. We are working to reverse this situation for the year, but we needed to be cautious.
A further point on our contract revenue guidance is it excludes any potential milestone revenues from AMRI's biogenic amine collaboration with Bristol-Myers Squibb or any other project.
Moving from contract revenue, we expect royalty revenues to decrease by 5% in 2008 based on growth offers overseas offset by continued erosion in the US Allegra market.
Turning to margins, we expect gross margins to increase 2 to 3%. In reality, our gross margin improvement is higher, but we have to offset the impact of the re-negotiation of our largest commercial contract which resulted in a 2% hit to company gross margins. We however, believe we have strengthened our ability to retain this cluster beyond the current contract period.
From a cost standpoint, we project R&D to grow by 10% as we advance our tubulin inhibitor program into Phase I clinical trials in 2008. We expect SG&A to increase 8 to 10%. We were estimating earnings per share for 2008 to range from $0.33 to $037 representing up to 32% growth. And finally, we were estimating 15 to 20 million in capital expenditures in 2008. Our EPS estimate assumes there is no at-risk launch of a generic version of Allegra-D.
I will now discus Q1 guidance. For the first quarter of 2008, we estimate contract revenue to range from 38 to 42 million, an increase of up to 2% from 2007. To get to the range of 38 to 42 million we project discovery services revenue to range from 11 to 12 million, an increase of up to 20% over 2007 level. We anticipate development and small scale revenue to range from 11 to 12 million, an increase of up to 12% for 2006.
We project large scale revenue to range from 16 to 18 million a decrease of 14 to 32% over last year. This decrease is primarily due to other legacy commercial orders not repeating as mentioned earlier. In addition, the DEA quota restriction will have a negative impact on our ability to manufacture and ship the active ingredient providence.
We expect royalty revenues decrease by 5% from Q1 2007. We expect gross margins to decrease by 5% to 8% from first quarter 2007 levels, because of the lower revenue and large scale.
From a cost standpoint we project R&D to grow by 25 to 30% from first quarter 2007 and SG&A to increase by 5 to 7%. We were estimating earnings per share for Q1 2008 to be from flat to $0.3 per share down from $0.10 per share in the first quarter of 2007. Again our EPS estimate assumes there is at-risk launch of the generic version of Allegra-D.
I will now turn the call over to Dr. D'Ambra, who will continue with additional comments.
Dr. Thomas D'Ambra - Chairman, President and Chief Executive Officer
Thank you, Mark. Looking back at 2007, we can be please about several positive developments. I will touch on this later in my remarks. Unfortunately, the fourth quarter fell below our expectations and overshadowed a solid first three quarters and the forward progress achieved on several fronts which will shape our future.
We are focused today on the most recent quarter. We have continued to work on multiple strategic initiatives and investments which deliver progress during the past year. As we look backward, we can identify areas of improvement for further focus during the coming year. But also as we look backward, we can identify developments to set the stage for what we believe will be another positive year for strategic growth for AMRI.
Turning first to our contract services business segments, overall trends for our discovery services are positive, we continue to point to a strong 2008. Medicinal chemistry in both the US and Singapore was nearing capacity at year-end and aggressive hiring plans for additional scientist are in place to meet anticipated growth in 2008.
We attribute this increase in demand primarily to orders from large pharmaceutical companies. We believe this to be the beginning of a sustained trend by big pharma towards a return to longer term, high quality outsourcing relationship. Beside large pharma, our continued focus on diversifying our customer base has resulted in contracts with biotech emerging pharma companies, government agencies and non-profits
Our high-breed model with locations in Singapore, India, and Hungary is not only gaining attention in Europe and Asian markets, but has also resulted in pullthrough business back to our U.S. locations. Growth and customer contracts and subsequent increasing capacity in Singapore is driving the construction of an approximately $5 million expansion to lab 60 chemistry hoods from distal chemistry and discovery in research and development.
In response to demand, we are also building laboratories for InVitro Biology in Singapore, currently, only been performed at our Bothell, Washington facility. One customer is already committed to using InVitro Services upon completion of the Singapore build out which we anticipate by the end of the second quarter. While we did not meet the financial and growth expectations set for our discovery operations in Hungary in 2007, we believe continued focus on our strategy here will yield positive results.
We initiated a number of actions in the second half of the year to address shortcoming. Besides bringing on board in Budapest, the leadership in scientific expertise Dr. Philip Small last November. We are continuing to recruit additional experienced scientist. We are also making investments in equipment to increase the technical vitality of the site. In addition to increasing expertise and scientific capabilities, our global sales force expansion was motivated impart to increase our presence to customers in that market space.
We are also dedicated to increasing the size of our medicinal chemistry team in Europe as we believe there is a significant market for medicinal chemistry business in Europe that we have yet to significantly tap.
On the strategic technologies front, we continue to experience an uptick in demand for natural product screening services. Besides the recent announcement of our natural product based research collaboration with the cystic fibrosis foundation, worth up to $23.7 million. We initiated similar collaborations during 2007 with three other customers, incorporating in all of them the opportunity to receive upfront payments, funded research, downstream revenue potential or various combinations of these.
We think this trend supports our belief the interest in the industry for drug discovery screening collaborations will continue in 2008. Chemical development in small scale service performance remained strong with the 22% increase in contract revenue for the fourth quarter and 26% growth for the full year.
We are pleased to report a steady increase in demand for three years in a row, as well as a continued steady stream of request for repeat business. We believe this to be a positive indicator for the future, both for this segment as well as for our manufacturing business, anticipating that current small scale project have significant potential to generate future business as cost for compounds move through the clinical pipeline towards commercialization.
The backbone of our growth in this business segment is occurring at our U.S. locations, demonstrating the high-quality and high-performance are not commodities and the expertise and experience we have assembled within AMRI continued to lead the industry in this growing market segment. Executing against our hybrid services strategy, we have made significant inroad setting up operations in India. In Hyderabad, we are now conducting all contract projects in our new 50000 square foot research and development facility.
In 2008, our plan is to continue expansion at this site to gain critical mass. A Multi-by Kilo lab has recently been commissioned provide multi kilo custom synthesis beyond the crowded gram-scale custom synthesis market in India. Our in-goals in Hyderabad remain aggressive as we are ramping up to keep pace with anticipated future customer demand. We are progressing with the integration of our recently purchased large scale manufacturing plant facilities in Aurangabad, which has been renamed as AMRI, India.
Having stabilized operations and existing product manufacture including three generic APIs, the plants we’re producing prior to acquisition. We are now strategically positioned to pursue the manufacture of additional raw material, generics, and intermediate. We have set goals during 2008to complete the application process for U.S. drug master files for the generic APIs, currently being made. As we indicated when we announce the purchase of these manufacturing facilities, the strategic value we envisioned was not for the existing base of generic products, but for the opportunity to expand our facilities to allow us to prepare custom GMP and non-GMP intermediates, and to leverage our US supply chain by back integrating raw materials or intermediates currently purchased for or made at our Rensselaer plant.
With the acquisition and integration completed, these longer term goals are beginning to be addressed, although it should be noted that these efforts will take some time.
The integration of large-scale India during the fourth quarter had a negative impact on operating performance of $0.2. Inline with our strategy of adding resources in Aurangabad for potential higher value projects, we have just completed the purchase of a pilot plant facility located close to our current Aurangabad, India operation. This purchase accelerates our ability to manufacture custom pilot scale intermediates and add the fourth compound to our generics portfolio. Plans are underway at both Aurangabad locations to upgrade infrastructure and increase capacity including making the facilities US GMP compliant. The purchase price and the impact of this additional facility on our 2008 performance are not material.
In our large scale manufacturing operations in the US at Rensselaer, we acknowledge some under performance and goals set for 2007. Despite not achieving overall year end goals, it is appropriate to know year-over-year progress post restructuring that occurred just over a year ago.
Despite year-over-year revenues for US large scale that were down 1% the unit delivered decent improvement in margins and set the stage for continuation of this trend in 2008. Mark has already touched on this. Mark has also touched on revenue recognition for large scale. I would like to expand on his comments.
Besides revenue recognition been affected by unexpected delays in the shipment of certain compound, a new challenge to revenue and margins on a large scale side is the impact of regulatory control on our ability to manufacture Vyvanse. While we received firm orders for last year and have orders and forecast from Shire for 2008. We were impacted in late 2007 by lateral quarter and have not received necessary DEA controlled substance approvals for all the Shires anticipated 2008 demand.
Under law, we cannot start manufacture until approved quarter is received. The impact of DEA Regulation on the production of the active ingredient for Vyvanse during product sales ramp up may cause some volatility for us during the year in terms of what we can manufacture, shift, and recognize revenue for this product.
In addition to Vyvanse, we are also working on a second generic API which is regulated by the DEA. We've not announced our second contract. In addition to the delays in DEA quarter we have experienced with Vyvanse, the ability to manufacture the second active ingredient is also subject to DEA quarter.
In our guidance release today, we have forecasted that our large scale business will be impacted by the inability to produce this second product during the year. We're in contact and working with the DEA on these quarter issues.
Mark alluded in his remarks to another situation that came up late in the year with our biggest product which we manufacture for GE Healthcare. We were approached to re-negotiate our contract which currently runs to 2010 with a request to provide discounted pricing for 2008.
In support of our long-term relationship and our desire to deepen and cement the relationship longer term post 2010, we agreed to a price reduction effective immediately. While this will result in an impact to profit margins at large scale that was unexpected, we believe our decision was in the best interest of the business. Although, there is no guarantee that we'll be able to continue the relationship with GE Healthcare beyond 2010, we anticipate beginning discussions in 2008 to explore potential contractual relationship beyond the current term.
We believe this to be an instance where our worldwide capabilities and flexible cost model approach could be helpful. In this case, the potential to perform a portion or even all of this manufacturing work in our facilities in India should give us leverage that we would not have with just our US facilities.
As Mark had mentioned, even with the GE Healthcare margin giveback we’re expecting continued year-over-year margin improvements in our business that were more than offset to giveback.
In addition to our contract services we have had much activity on the DR&D or Drug Research and Development front, which we believe to be the precursor to some significant events in 2008.
In the second quarter of 2007, we received a $1.5 million milestone payment from our license and research agreement with Bristol-Myers Squibb for the successful nomination of a lead compound in the preclinical development
The ongoing advanced preclinical testing continues favorably, we believe a Phase I clinical study on this compounded man will be started in 2008. This would result in an additional milestone payment. Additionally, BMS will continue to review other candidates generated in this series for other possible preclinical leads that may result in additional development compound. We remain enthusiastic about this program. Work is also ongoing on our anti-cancer program. This program has not been partnered. We have previously announced that the compound was ready to move into Phase I clinical studies that would have an IND filed by early 2008.
We unfortunately experienced a failure by the contract formulator resulting in a delay for the IND filing. We are close to identifying a new formulator and are optimistic that we will be on track to move ahead in the coming weeks. A clinical serial has already been retained and locations agreed to for conducting the Phase I trials. We expect the IND to be filed latest by early in the third quarter of this year. On our website we described several other programs in our R&D pipeline making forward progress.
AMRI programs for obesity and irritable bowel syndrome look promising, and we believe there is near-term potential for the designation of preclinical candidates before the year is out. We look forward to sharing more about these programs in future announcements.
Across all of our business segments we have strengthened our leadership team with the addition of fore seasoned veteran at the helm of critical operations including manufacturing small scale sales and business development in Hungary and Singapore. These individuals bring proven track records in leadership and in the setting of entertainment as a find objective.
Along these lines, the key driver for business performance this year will be the effectiveness of our global sales organization. Toward that end, AMRI has recently initiated a sales team restructuring focused on the creation of a global sales force, capable of canvassing project opportunities worldwide, employing the companies flexible cost and location model. We will also be placing increased scrutiny and resources on global marketing campaign. We have significantly increased spending on sales and marketing and are already beginning to recognize a return on these investments. I would also like to make a few comments on the stock buyback we announced this morning.
Last week on February 7, at our regularly schedule meeting of our board of directors, the board authorized a stock repurchase program up to $20 million. Given the market value, the company relative to book value, we in the board believe company performance in 2007 along with our strategic initiatives underway have not been appropriately valued by the market place. The company has a strong cash position, we continue to generate significant cash and we expect to continue to generate cash during 2008. While this authorization demonstrates board and management commitment and belief in the long term prospects of the business. We still retain a strong cash position allowing us the flexibility to pursue potential strategic initiatives that may arise, if any.
In ramping up my remarks, AMRI during 2007 demonstrated overall continued progress in many areas of our business. We’ve identified where additional improvement can be made for 2008. There are many bright spots in our business that continue to look strong for the coming year. We continue to foster our investments overseas and have made investments in new leadership in the sales and marketing the infrastructure that is already making positive contribution. We know that 2008 will present its own challenges, but as we begin the New Year, we are optimistic about our future. AMRI is competing on a global platform in a relatively new and rapidly growing industry.
With our focus on high quality standards, practicing innovative science, delivering first class customer service and a strong desire for continuous improvement, AMRI is in position to deliver another year of improved results. We look forward to sharing our progress with you during the coming quarters.
I would like to conclude by thanking our employees and colleagues at AMRI. The dedication and contribution are the reasons that AMRI is successful today and in position to have a great future. Thank you also for your interest in AMRI. At this point, I would be happy to answer any questions.
Thank you. (Operator Instruction)
And we'll take our first question from Amy Stevens with Susquehanna Financial.
Yes, good morning guys. Thanks for taking the question. I just wanted to follow-up a little bit on the DEA quota situation with regard to Vyvanse as well as the second generation; second generic API that you said will be regulated by the DEA. Can you just go into little more depth in terms of what needs to be done to resolve that situation?
I think the matter is fairly simple. We were waiting for DEA quota to be able to begin manufacture of ceratin amounts of Vyvanse. We've some quota for Vyvanse, just not all the quota that will be required to manufacture all of the orders that we currently have from Shire. That also impacted some orders in 2007 that we were not able to make because we didn't have quota.
We are meeting with the DEA, Shire is also meeting with the DEA and we are working with them to get that quota. One of the issues there is that the product is ramping up and historically the DEA likes to meter out quota based on expected sales, so they look at past IMS Data and given that this product is in an early ramp up stage that’s very difficult to meter out with the expected growing demand so.
They essentially don't want manufacturing and shipping to exceed what they believe the demands for (inaudible).
They are trying to closely control it. So, we and Shire are vigorously working with the DEA for that.
And what about in terms of the second generic API, it is regulated by the DEA; you said that this one is also subjected to DEA quota and that you felt that you wouldn't be able to make the amount in 2008. I guess that you had contracted for or how, what percentage of what you expected are you at or will you be at?
This product that I mentioned is not in our forecast for the year. We have taken it out for our large scale forecast. This relates to a generic that we have talked about before, we partnered with a company. The DEA will not grant quota until an AMDA is approved. So, this is a case that we would be unable to make pre-launch quantities before approval, so we have to wait for the AMDA to be approved so to be conservative that we forecasted that approval will not occur this year.
And what timing metrics do we have in terms of the approval, the AMDA approval?
We believe that either later this year, we're forecasting now in 2009. That would be upside if approval were to occur later in the first half allowing us time to manufacture and ship the quantity.
Okay. And then following up on the adjustment in your contract with GE Healthcare, if you looked at obviously other customers, partners could indeed look for similar concessions. Have you thought about that? How might you guide us to think about it?
Clearly the relationship with GE is the largest we have in large scale. We think this is a one-time event. Clearly for any contract, for anybody that's always a risk, but we think that it’s an isolated situation.
Okay. I think that's it for now. Let’s get back in queue. Thank you.
(Operator Instructions). And it appears we've no further questions at this time. I'd like to turn the conference back over to Dr. Thomas D'Ambra.
Dr. Thomas D'Ambra - Chairman, President and Chief Executive Officer
This concludes our earnings call for this morning. Thank you again for your interest in AMRI.
And once again ladies and gentleman this does conclude today's conference. Thank you for your participation. You may now disconnect.
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