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Executives

Bob Burrows – VP IR

Fuad El-Hibri – Chairman, CEO

Don Elsey – CFO

Mike Langford – President Product Development Gaithersburg

Analysts

Richard Smith – J.P. Morgan

Daniel Mallin – WBB Securities

Emergent BioSolutions Inc. (EBS) Q4 2007 Earnings Call March 7, 2008 9:00 AM ET

Operator

Good day ladies and gentlemen and welcome to the fourth quarter 2007 Emergent Biosolutions Incorporated earnings conference call. My name is Francis and I will be your coordinator for today. At this time, all participants are in a listen only mode. We will conduct a question and answer session toward the end of this conference. If at any time during this call you require assistance, please key star followed by zero and a coordinator will be happy to assist you. As a reminder, this conference is being recorded for replay purposes. I would now like to turn the presentation over to your host for today, Mr. Bob Burrows, Vice President of Investor Relations, please proceed.

Bob Burrows

Thank you Francis. Good morning ladies and gentlemen and thank you for joining us today as we discuss Emergent Biosolutions financial results for the year 2007. As is customary, our call today is open to all participants. In addition, the call is being electronically recorded and is copyrighted by Emergent Biosolutions. Joining me on the call this morning is Fuad El-Hibri, our Chairman and Chief Executive Officer and Don Elsy, our Chief Financial Officer. Additionally, other members of senior management will be present on the call for purposes of Q&A and they are Dan Abdun-Nabi, President and Chief Operating Officer of the company and Dr. Mike Langford, President of our Product Development subsidiary in Gaithersburg, Maryland.

The agenda for today’s call will be, following my brief introduction, Fuad will provide comments on our accomplishments from 2007 and key milestones for 2008. Don will then review in detail our financials for 2007 and provide comment on our financial guidance for 2008. We then will move to the customary Q&A session.

Please note that any statements about the company’s prospects or future expectations are forward looking statements. As you know, forward looking statements involve substantial risks and uncertainties and actual results may differ materially from expectations. Please refer to the press release issued earlier today and importantly to our filings with the SEC for more information on the risks and uncertainties that could cause actual results to differ. Also, Emergent Biosolutions assumes no obligation to update the information in today’s press release or as presented on this call, except as may be required by applicable laws or regulations. Today’s press release may be found on our website at www.emergentbiosolutions.com under investors slash press release. And with that brief introduction, I would now like to turn the call over to Fuad El-Hibri, Emergent Biosolutions’ Chairman and CEO. Fuad.

Fuad El-Hibri

Thank you Bob, good morning everyone and thank you for joining us today. As you know, 2007 was our first full year as a public company during which we met or exceeded all of our key objectives to get set for the organization for the year. We achieved both financial and operational success. Operationally, we sold more of our licensed product [class rank] and accomplished key product development milestones. We also advanced our manufacturing expansion program and completed key business development objectives. Building upon our performance in 2007, I am confident we will achieve our key goals for 2008. With that introduction, I will now discuss in some detail our 2007 accomplishments across a broad spectrum of issues and I will also discuss our key goals for 2008.

Let me start with our 2007 financial accomplishments. In 2007, we reported another year of record revenues of $183 million and net income of $23 million which represents our sixth consecutive year of profitability. During 2007, we continued to reinvest internally generated cash into our product pipeline in pursuit of vaccines and therapeutics that address significant unmet or underserved medical needs. With more than $100 million in cash at year end and visibility into projected revenues in 2008, we are well positioned to pursue the acquisition of one or more late stage product candidates which will compliment the advancement of our product portfolio. This is one of our primary corporate goals for 2008. Don will provide more detail on our financial results for 2007 in a moment. Let me turn now to our operational accomplishments, specifically marketing and sales, product development, manufacturing and business developments. I will begin with our marketing and sales accomplishments.

Notably, we succeeded in capturing a greater portion of the HHS requirements for the stockpiling of anthrax vaccine. In 2007, we signed the largest contract in the history of our company, a $448 million three year fixed price contract that includes the delivery of 18.75 million doses of Biothrax to HHS. Internationally, we completed meaningful sales of Biothrax to allied foreign governments while pursuing growing interests from a number of other countries. And we continued to pursue licensure of Biothrax in select foreign markets which we believe will facilitate sales to governments in these markets. Moving on, I will now comment on certain of our product development accomplishments.

In 2007, we achieved significant progress in advancing our pipeline candidates. Specifically, our anthrax IG therapeutic was granted fast track status by the FDA and received additional funding of $9.5 million in the form of a development contract with BARDA and NIAID. Our single dose oral typhoid vaccine completed a phase two clinical trial in Vietnam, achieving all end points for safety and [unintelligible]. This product will be the world’s first single dose renewable typhoid [unintelligible]. And our hepatitis B therapeutic continued to advance in its current phase 2 clinical trial following a positive safety monitoring committee review. Now let me turn to our manufacturing accomplishments during the year.

We strengthened our manufacturing capability with the completion of the construction and equipment installation of new facility located in Lancing, Michigan. Recently, we initiated engineering runs for Biothrax in preparation for the upcoming submission of our supplement to our BLA to FDA to allow us to manufacture Biothrax in this new facility. Remember, this facility is campaignable which would support manufacture of different types of vaccine. I am pleased to report that this state of the art large scale manufacturing plant is coming in on time and within budget. We also recently commissioned the pilot plant in support of manufacturing clinical materials for advancing product candidates. Lastly, let me review key accomplishments with respect to our 2007 business development activity.

We continue to develop partnerships with government and non government entities in strategic growth markets. Specifically, we formed a joint venture in Malaysia with 9Bio to supply Biothrax and other medical and [vitasense] products and related services to the government of Malaysia as well as potentially other countries within Asia. Additionally, improvements of one of our major strategic goals to actively evaluate in multiple business development opportunities. Yesterday, we announced acquisition of the monoclonal product candidate against anthrax. This acquisition is designed to round out our anthrax franchise and that it enables us to develop an additional therapeutic candidate in parallel to our AIG therapeutic which continues to be well positioned for procurement contract as early as next year.

These development activities have positioned us to pursue an acquisition of one or more late stage product candidates this year which would complement the advancement of our product portfolio. Now let me turn to our outlook for 2008. I will start with our marketing and sales objective for this year. We’re looking towards expanding sales for Biothrax to the US government by satisfying DODs continued requirements under the active vaccine immunization program. We’re striving to expand the reach of our product to other governments through the appointment of additional marketing agents and international distributors in key foreign markets.

And we are expecting the growing demand for Biothrax through increased efficiency in our manufacturing operations and ultimately introduction of our new large scale manufacturing facility in Lancing. With respect to our typhoid vaccine, we intend to establish a sales and marketing plan for product launch and growing commercial [unintelligible]. Next, let me touch on the 2008 development objectives for our product candidates. We plan to initiate and substantially complete pivotal human and non clinical trials for our anthrax IG therapeutic. This should position us for a sizable procurement contract as early as next year.

We plan to initiate a phase 2B study in the US for our oral typhoid vaccine, building on the successful completion of our phase 2 trial in Vietnam last year. In addition, we plan to start surveillance for our phase 3 trial in India which we expect to begin in 2009. In parallel, we anticipate initiating a phase 3 trial in the US and EU that same year. With respect to our hepatitis B therapeutic, we expect to receive preliminary safety and efficacy data from the ongoing phase 2 study at the end of this year.

Now, let me touch briefly on our manufacturing outlook for 2008. We expect to complete process validation of the large scale manufacturing of Biothrax in our new facility and to file a supplement to our BLA for [Biogen]. We plan to continue to improve our manufacturing efficiency in our existing facility which should result in enhance margins and greater production of targeted at 8 million doses for 2008.

Lastly, let me touch on our business development objectives in 2008. We plan to complete the acquisition of one last late stage product to augment our advanced pipeline in line with our corporate growth strategy. In addition, we’re aiming to secure additional NGO and government grant funding to advance multiple products in our pipeline. In conclusion I would like to take a moment to remind you of our key drivers for growth. These are five important principles that guide our decision making process. They are as follows, we’re focused, we develop products [to improve our concept to] commercialization. We’re balanced, we develop both vaccines and therapeutics serving multiple markets.

We’re profitable, we manage our business in a fiscally responsible manner. This has helped us achieve a track record of financial success that has enabled us to fund our pipeline development. We are collaborative, we aim to establish non dilutive partnerships with governmental and nongovernmental organizations in the US and abroad to leverage our investment in the development of our own product [unintelligible]. We are inquisitive, we pursue the licensure and acquisition of products and product candidates that leverage our existing capabilities and expand our pipeline opportunities. Protecing lives is our corporate mission. Our 2007 achievements have laid the groundwork for successful completion of our goals for 2008 and beyond. I look forward to keeping you apprised of the progress we make throughout this year. That concludes my prepared comments. Don will provide greater detail on our financial results for the year. Don.

Don Elsey

Thank you Fuad, good morning everyone. As Bob mentioned, we released our full year 2007 financial results this morning prior to the opening of the markets. The press release is now available on our website. Later today we will be filing on our annual report on form 10K with the SEC. The 10K will be available on our website and on the SEC’s website once it has been filed. As Fuad mentioned, 2007 was a very positive year for Emergent and we were very pleased with our financial results for the year.

We have now had four consecutive years of revenue growth and six consecutive years of profitability. Our product sales to both US and foreign government customers have allowed us to continue to reinvest internally generated cash into our product development pipeline. Looking ahead, the devised schedule of dose delivery under the current contract with HHS over the next two years and the resulting revenues generated from these deliveries position us well to continue investing in our advanced and follow on product pipeline, pursue additional markets for Biothrax, to make additional investments in our manufacturing and development infrastructure, we will also continue to pursue our strategy of growth through opportunistic acquisitions as we look to build out our product pipeline opportunities.

Now, I would like to give a summary of our financials for 2007 and I’ll start with product revenues. 2007 product sales increased by $21.8 million or 15% to $169.8 million from $148 million in 2006. The increase in revenue was driven by a 41% increase in the number of doses of Biothrax delivered, somewhat offset by a 19% decrease in the average sales price per dose. The decrease in the average sales price per dose was due to a one time discounted price for a portion of the doses delivered to HHS in the third and fourth quarter. This was due to a remaining shelf life for those doses that was less than usual. This discount will not apply to any other doses to be sold and delivered to HHS under our current multiyear contract.

The $169.8 million of product sales for 2007 consisted of sales to HHS of $141.6 million, sales to DOD of $26.2 million and sales to international and other customers of approximately $2 million. Fourth quarter 2007 product sales revenues were $80 million, a decrease of approximately $6.7 million from the $86.7 million that we sold in 2006. The decrease in revenue for fourth quarter was due to the influence of the discounted price per dose just mentioned. Turning to contract and grant revenues, 2007 contract and grant revenues increased by $8.4 million to $13.1 million from $4.7 million in 2006. Contract and grant revenues for 2007 consisted of a milestone payment of $8.8 million from HHS in connection with the completion of a human clinical study used to support expanding the indication for Biothrax to include post exposure prophylactic.

It also included $3.1 million from our collaboration with Sanofi Pasteur and a total of $1.2 million in grant revenue from NIH and the [Walt] County trust. Fourth quarter 2007 contract and grant revenues were $9.6 million, driven by the milestone for the post exposure indications just described. Moving on to the cost of product revenues and gross margins. Our costs of product revenues increased overall to $40.3 million in 2007 driven primarily by the delivery of additional doses. The overall gross profit margin for 2007 declined from 84% in 2006 to 78% in 2007. This decline was driven by the discounted price per dose in the fourth quarter. As indicated earlier, we do not expect this to occur in the future and expect improved gross profit margins in 2008. Fourth quarter 2007 costs of product sales increased to $17.5 million from $12.5 million in 2006, reflecting the impact of the increase in the number of doses of Biothrax delivered during the quarter.

Turning now to expense and looking first at R&D expense, 2007 R&D expenses increased by $8.5 million or 19% to $54 million from $45.5 million in 2006. This increase was driven by our continued investment in advancing the development of our product pipeline and reflects spending on both personnel and on external contract research. Fourth quarter 2007 R&D expenses decreased to $12.3 million from $16.3 million in the fourth quarter 2006. This basically reflects the typical variation in the timing of R&D spending. Turning to SG&A expense. 2007 SG&A expenses increased by $11 million or 25% to $55.6 million from $44.6 million in 2006.

This increase which was a trend throughout 2007, was driven by an increase in staffing and in legal and other professional service spending to support the requirements of being a public company and supporting our overall growth as a company. Fourth quarter 2007 SG&A expenses increased to $16.7 million from $14.2 million in the fourth quarter 2006 or 17%, reflecting a leveling off of the increase of spending in this area. To finish up on the P&L, we’ll look at net income. For the full year 2007, our reported net income of $22.9 million was $0.77 per diluted share. In 2006, our full year net income was $22.8 million or $0.93 per diluted share.

As of yearend 2007, our weighted average diluted shares had increased by 5.1 million shares or 21% to 29.7 million shares. For the fourth quarter of 2007, we reported an increase to net income to $27.7 million or $0.93 per diluted share from $26.1 million or $0.99 per diluted share in 2006. Looking at the balance sheet, to highlight as Fuad mentioned earlier was in the area of cash. Cash and cash equivalents at year end was $105.7 million versus $76.4 million at December 31st 2006. The net increase resulted primarily from net cash provided by operating activities of $54.8 million and net cash provided by financing activities of $18.5 million offset by net cash used in investing activities primarily the construction of our Lancing expansion of $44 million. Finally we would like to address our previously published 2008 financial guidance. For 2008 we are reaffirming our expectations for full year total revenues of between $180-$195 million and net income in excess of $20 million.

In 2008 we expect another year of growing revenues and maintaining profitability. We will continue to use our internally generated cash flows to invest in our product pipeline. Our year end 2007 cash reserves will allow us to pursue a strategic objective of acquiring additional late stage product candidates. That concludes my prepared comments, I will now turn the call to the operators so that we can begin the question and answer portion of the call. Operator, if you would please proceed with Q&A.

Question-and-Answer Session

Operator

Thank you, ladies and gentlemen, if you wish to ask a question, press star one on your touchtone telephone. If your question has been answered or you wish to withdraw your question, press star two. Questions will be taken in the order received. Press star one to begin. Your first question comes from the line of Richard Smith with J.P. Morgan, please proceed.

Richard Smith – J.P. Morgan

Yes, good morning. Just a couple of questions, one would be anthrax antibody that you’ve just licensed in, could you give us a sense of the next steps for that product, when that might be in a position to be licensed, would it be something to look out into 2009 and just could you give us a sense of where you stand on the development of maybe second or third generation anthrax vaccine, please.

Fuad El-Hibri

Thank you Richard, I’m going to ask Mike to answer the first question and I will answer the second one.

Mike Langford

So on the anthrax therapeutic that we just [did] license, we had submitted a contract where [we searched], contract that with Asian [deniad], we’re anticipating that award to be announced in September. So the next steps for that product are if you take it [unintelligible] process development for commercial scale manufacturing to go ahead and execute the non clinical efficacy studies and then to go ahead and begin and complete the phase 1 clinical trial for that product. So as it stands we look to advance the development of the product probably beginning this fall. I anticipating an award. So it we’re very excited about this new acquisitions because it really positions us in both, on both tracks, the polyclonal AIG track and the monoclonal one where we compete with [HGF]. So we believe it’s a very strong candidate and we believe that we have a good chance of getting some funding [unintelligible].

Richard Smith – J.P. Morgan

Would it be fair to say that given what you’ve seen with HGSI that the path for future development is pretty much laid out for you?

Fuad El-Hibri

Yes, you know it’s always good to be the first to market but sometimes it’s also advantageous to be the second and to basically follow the footsteps of someone who has gone through the trials and tribulations. So we’re very optimistic and we understand that the government likes to pursue multiple suppliers and we believe that we are well positioned.

Richard Smith – J.P. Morgan

Okay and on the second and third generation anthrax vaccine?

Fuad El-Hibri

Yes before I go there let me just say one more thing about the monoclonals versus polyclonals. We do believe that both requirements stand in parallel. So now to the next question which is you asked what’s happening with the second and third generation. Let me start with the third generation. Third generation [unintelligible] by NIAID for the development of what is truly a suitable product with a long shelf life with antigens sparing attributes and with potentially a strong [unintelligible] that would accelerate the immune response. So we submitted some bids under that RFP and we expected to hear from NIAID sometime in July of this year. We believe that we’re well positioned as a key player for the next generation. With respect to second generation, as you know recently an RFP came out that stated that the government is interested in purchasing 25 million doses of a second generation product.

Now the second generation to remind everyone is really pretty much the same as our product expect instead of using native [PA] as the primary antigen it’s recombinant [DA]. Again the antigen aluminum [unintelligible] and it is an injectable as it is with ours. So we believe the government is interested in continuing to pursue that for the multiple supplier [unintelligible] and for good reason. We are evaluating at this point as to whether and how we best bid for this, under this RFP. And we’ll keep you abreast of any [unintelligible] developments.

Richard Smith – J.P. Morgan

Okay, thank you very much.

Operator

Your next question comes from the line of Daniel Mallin with Web Securities, please proceed.

Daniel Mallin – WBB Securities

Hi guys, congratulations on the quarter and the year. Most of my questions were just answered, they were on really the two things that you just talked about, but more specifically on the recent acquisition for the anthrax monoclonal antibodies, I realize that the government has you know stated its intent to acquire products from both categories. Do you think though that there’s really room in the stockpile for both, or is it ultimately whichever proves to be more efficacious in terms of treating anthrax on a post exposure basis is really going to win?

Fuad El-Hibri

Well I think in the long run, whichever is more effective is going to win. But I think in the short and medium term, the government seems to be committed to pursue both tracks simply because there might be some shelf life differences. There may be some efficacy differences and there may be some price differences. So it is our view that both tracks are going to be relevant for at least the medium term, 3-5 years and then maybe thereafter, you know there might be a down selection [unintelligible] one company but in terms of on track.

Daniel Mallin – WBB Securities

Okay and then in terms of the HHS versus DOD procurement, I know that all of the current procurement is through HHS. You know, however, it’s possible that some of the doses that are currently being acquired could be being shipped to DOD. I realize this is a sensitive issue but are you seeing any indicators in terms of how and where you’re shipping, I mean previously you were shipping to two different people. Are all of your shipments basically all going directly to HHS or are you doing any other shipments that would lead you to believe that some of the current doses being produced are actually being used directly by the military for [executive] immunization program.

Fuad El-Hibri

I guess the best way I can answer this Dan is that the government has decided to procure Biothrax through one government agency and as it stands now its HHS, the larger purchaser of our vaccine. We also understand that DOD will continue with its active immunization program and that any purchases or requirements that they have will be purchased through HHS and HHS will in turn purchase additional doses for them. That is our understanding and as DOD starts looking at their 08 requirement this year’s requirement, we do expect that that will result in further purchases by HHS.

Daniel Mallin – WBB Securities

Okay and lastly I know you touched on this in the call but what is the timing in terms of the completion of the new plant and the expansions in Lancing? When do you expect to be fully operational is what I’m getting at.

Fuad El-Hibri

Right, so we’re doing engineering runs and after the engineering runs we would start process validation and so we expect to submit a DLA supplement sometime this year. And then you know you have your normal six to 12 month review period. So we expect that if everything goes well that sometime in 09 we may be licensed to a manufacturer of anthrax in the large scale facility.

Daniel Mallin – WBB Securities

And as you said its scalable so whether one of your own candidates is commercial at that point or potentially you might actually be prepared anyway to purchase something that’s already commercial with an eye towards moving the manufacturing or close to be commercial into your new facility?

Fuad El-Hibri

Absolutely. I’d like to underscore that this facility was designed to be campaignable, so it is not only restricted to manufacture Biothrax but potentially other recombinant and other fermentation stages vaccine candidates. So yes we will be looking at bringing other products in for manufacturing them.

Daniel Mallin – WBB Securities

Can I ask one quick question on RPA, I know I’ve kind of monopolizing on the time here.

Fuad El-Hibri

You’re asking some good questions Dan.

Daniel Mallin – WBB Securities

You know on RPA it just seems like it’s just the RFP that just keeps coming back and it just doesn’t seem to want to go away. You know a while back if you looked at the public filings from Vacgen, you know I thought it was very interesting that in those filings they basically stated outright that they tried to sell their RFP asset and couldn’t get what they considered to be a reasonable bid. Having said that though, if you look at the timing under this RFP that just hit the system, you know if you extrapolate forward with reasonable expectations of what somebody can deliver, when would you think that somebody else’s RPA under this RFP could potentially be in the marketplace?

Fuad El-Hibri

Let me start by saying that RPA is experimental. Vacgen had some issues. Whether [aveesha] RPA has any issues, we can’t speak to. But what we can say is that the RFP allows for 5-8 years to deliver into the stockpile and going through the process of getting post to licensure will take time. And at the end, we may have a product that may have only about 18-24 months stability.

Daniel Mallin – WBB Securities

It says right in there that they’re looking for up to 24 months of stability so they’ve already seemed to cut back on that expectation from the previous RFPs so.

Fuad El-Hibri

Correct and if you look at stockpiling economics, you know if you compare a product that has only 18 month or a 24 month versus one that may have you know 36, 48 or even beyond month, it becomes a very interesting economic question, financial question. Also, you know it’s still unproven RPA as to whether it has the same efficacy as [viotrack]. But we do understand that the government would like to diversify their supplier base and have multiple suppliers for such a strategic and important product.

Daniel Mallin – WBB Securities

Any feedback from the FDA yet on Biothrax for post exposure?

Fuad El-Hibri

We’re working it hard. We are on track. We have a contract with HHS in which they actually are [funding] towards the completion of our test indications and you know we’re pretty much following through with what the contract has asked us to do. Our target time for the, so this year we’re looking at having an additional clinical study and next year if everything goes well we should be in a position to submit [unintelligible].

Daniel Mallin – WBB Securities

Okay well thank you again.

Operator

Ladies and gentlemen as a reminder to ask a question press star one. And there are no other questions in the queue. Pardon me we have a follow up from the line of Richard Smith from J.P. Morgan, please proceed.

Richard Smith – J.P. Morgan

Hi, just a quick follow up. The licensing or acquisition of an additional asset this year, could you just maybe give us some sense that you said this whether you believe that might be a bio defense asset or it might be something on the commercial vaccine side?

Fuad El-Hibri

That’s a very good question Richard. I mean when it comes to bio defense, we’re looking at broadening and deepening our franchise with respect to anthrax and botulinum and we’ve made some good progress with this acquisition to where you’re pretty close to being fully around [unintelligible]. On the commercial side we have two candidates that are in phase 2, positioned to go into phase 3 and there we’d like to see one or two more advanced stage commercial products. So our focus is going to be on the commercial side with respect to bringing in a phase 2 or potentially a phase 3 product.

Richard Smith – J.P. Morgan

Okay, thank you.

Operator

Thank you at this time there are no other questions in the queue and I’d like to turn the call back over to Mr. Bob Burrows for any closing remarks.

Bob Burrows

Thank you Francis. Ladies and gentlemen that concludes today’s call, thank you all for your participation. Please note that today’s call has been recorded and a replay will be available to you later today through March 21st. Alternatively there is available a webcast of today’s call and an archived version of which will be available later today, accessible through the company’s website at www.emergentbiosolutions.com and clicking on investors path. Thank you again and we look forward to speaking with all of you in the future. Goodbye.

Operator

Again thank you for your participation in today’s conference, this concludes the presentation, you may now disconnect and have a great day.

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