Earnings Call Transcript - EBS Q2 2011

Robert Burrows, VP, Investor Relations

Thank you. Good afternoon, ladies and gentlemen, again my name is Robert Burrows. I’m Vice President of Investor Relations for Emergent. And thank you all for joining us today as we discuss Emergent BioSolutions financial results for the second quarter of 2011. As is customary, our call today is open to all participants. And in addition, the call is being recorded and is copyrighted by Emergent BioSolutions. Joining me on the call this afternoon with prepared comments will be Fuad El-Hibri, our Chairman and Chief Executive Officer, and Don Elsey, our Chief Financial Officer. Additional members of our senior management team will be present on the call for the purposes of the Q&A session. Before we begin, I’m compelled to remind everyone that during the call, management may make projections and other forward-looking statements regarding future events and the company’s prospects for future performance. These forward-looking statements reflect Emergent’s current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve substantial risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements. You are encouraged to review Emergent’s filings with the SEC on Forms 10-K, 10-Q, and 8-K for more information on the risks and uncertainties that could cause actual results to differ. For the benefit of those you may be listening to the replay, this call was held and recorded on August 4, 2011. Since then, Emergent may have made announcements relating to topics discussed during today’s call. So again, please reference our most recent press releases and SEC filings. 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/Press Releases. And with that introduction, I would now like to turn the call over to Fuad El-Hibri, Emergent BioSolutions’ Chairman and CEO. Fuad?

Fuad El-Hibri, Chairman and CEO

Thank you, Bob. Good afternoon, everyone, and thank you for joining us on our call today. In my prepared comments, I will review our financial performance for the second quarter, discuss our revised full-year 2011 guidance, provide guidance on third quarter revenue, and highlight milestones related to our advanced stage development programs. I’d like to start with a summary of our second quarter financial results. We achieved total revenues of $88.1 million, which is within the $80 million to $90 million guidance we provided in our previous earnings call. We also realized net income of $14.2 million. As anticipated in our last earnings call, during the second quarter, we completed the qualification of the replacement reference matter, which enabled us to deploy our potency testing capacity to routine product testing and release. As of today, we have completed deliveries under the original 14.5 million dose contract. We have also now begun to make deliveries of the 3.5 million doses under the recently awarded contract modification. We expect to complete deliveries of all 17.9 million doses under this modified contract by the end of this year. Following the completion of deliveries under our current contract, we anticipate continuing to deliver BioThrax to the SNS under a new five-year contract currently in negotiation. We expect that contract will be signed in the third quarter and will provide for the delivery of 44.8 million doses over the next five years. Depending on the completion of deliveries under the current modified contract, deliveries under the new contract are expected to commence in late 2011 or early 2012. This multi-year procurement contract will commit substantially all of our current annual capacity over that period. Moving on to guidance, for the full year 2011, we now anticipate total revenues of $270 million to $290 million and net income of $15 million to $25 million. This revised guidance is primarily based on expected deliveries of BioThrax for 2011 of around 7 million doses. As you all know, our expected annual output can vary between 7 million to 9 million doses based on several factors, including fermentation yields, formulation of product, filling, potency and release testing, and the timing of delivery and acceptance of final product. When we initially prepared our guidance for 2011, we had been experiencing a three-year upward trend in fermentation yields as a result of multiyear process optimization activities. We had anticipated this upward trend would continue in 2011 and therefore anticipated our output would be closer to the upper end of the 7 million to 9 million dose range. However, year-to-date, the actual fermentation yields have been lower than what we had initially projected due to variability inherent in biologic manufacturing. The lower-than-expected yields are associated with the variability and the growth characteristics of our fermentation process. Our manufacturing process requires operation within tight specifications for both production and testing. Our process variability sometimes falls outside of these requirements, thus affecting production yields and the overall number of doses available for delivery to the SNS. We now project that the yield will be closer to 7 million doses this year. Finally, I would like to provide a brief update on our advanced stage development pipeline. For Anthrivig, we have agreed with the FDA on a regulatory path forward under the animal rule and have submitted to the FDA the final study report for the recently completed pivotal clinical trial. We are in the process of initiating two non-clinical studies. We expect to complete these studies by year-end. For TB, we have completed enrollment and vaccination of the 2,800 infants in the Phase IIb efficacy trial in South Africa. This month, we expect to announce the initiation of another Phase IIb efficacy study, this one in approximately 1,400 HIV infected adults aged 18 to 50, sponsored by Aeras. For SBI-087 in RA, enrollment in the Phase II dose regimen study has been completed. Patients are currently being treated and we anticipate announcing the results of this Phase II study in early 2012. For Z-mab, our late-stage anti CD4 monoclonal antibody for T-cell lymphoma, we are preparing for the completion of an ongoing Phase III study under an existing SPA. To remind you, in June, we acquired this product under license from Genmap. In addition to moving forward with the clinical program, we are also exploring partnership opportunities for this candidate. Lastly, let me give you an update on our manufacturing infrastructure in Lansing and Baltimore. For our Lansing facility, we have completed engineering runs in building 55 and anticipate completing the bulk manufacturing of consistency lots by year-end. For our Baltimore facility, we are on track to substantially complete facility modifications and to initiate tech transfer for our TB candidate, the first product candidate for this site, by year-end. Additionally, we continue to pursue acquisition and licensing opportunities with a focus on late-stage or revenue-generating products. In conclusion, for the second half of 2011, we look forward to continuing to deliver the remaining doses of BioThrax under the current modified contract. In addition, we remain committed to staying profitable through diligent management of our expenses while continuing to advance our late-stage development programs. That concludes my prepared comments. I will now turn it over to Don. He will take you through the numbers in greater detail. Don?

Don Elsey, CFO

Thank you, Fuad. Good afternoon, everyone. As Fuad mentioned, following the close of the markets today, we released our financial results for the second quarter of 2011. I encourage everyone to take a look at the press release, which is currently available on our website. We plan to file our quarterly report on Form 10-Q with the SEC later than the close of business tomorrow, Friday, August 5th, and the 10-Q will also be available on our website. Let me now briefly discuss our financial results. Total revenues for Q2, 2011 were $88.1 million, as compared to $62.1 million for Q2, 2010. As you know, total revenues are a combination of product sales and contracts and grants revenue. Let me give some further detail on the makeup of our Q2, 2011 total revenues. For the second quarter, product sales revenues were $71.5 million, an increase of $15.6 million or 28% over the prior year. This increase was primarily due to a 25% increase in the number of doses of BioThrax delivered. Product sales revenues for the second quarter of 2011 consisted of BioThrax sales to HHS of $70.7 million and aggregate international and other sales of $738,000. Moving on to contracts and grants, for Q2, 2011 contracts and grants revenues were $16.7 million, an increase of $10.4 million or 166% over the prior year. The increase in contracts and grants revenues was primarily due to revenues from our contract from BARDA for large-scale manufacturing for BioThrax and our collaborations with Abbott and Pfizer, along with increased activity and associated revenue from our other development contracts with NIAID and BARDA. Contracts and grants revenues for our Q2, 2011 consisted of $12.1 million in development contract and grant revenue from NIAID and BARDA and $4.5 million from Abbott and Pfizer. Now with respect to gross profit and gross profit margins, for Q2 2011, our gross profit was approximately 78%, which was slightly below the prior year, but within the range of typical gross profit margins, which are between 70% and 80%. Turning to R&D, our Q2, 2011 gross R&D expense was $31.5 million, an increase of $12.9 million or 69% over the prior year. This increase principally reflects higher contract service and personnel-related costs and includes increased expenses of $12.4 million for product candidates and technology platform development activities from our Biosciences division, primarily the programs we acquired as part of the Trubion acquisition in Q4, 2010. And if one takes into account the contracts and grants funding we have for many of our programs, our net R&D spend for Q2 2011 was $13.1 million. We remain committed to investing in the development of our product pipeline and expect our total R&D spending will continue to fluctuate quarter-to-quarter due to the various development stages of our broad pipeline of candidates. Next we turn to G&A. Our Q2, 2011 SG&A expenses were $20.4 million, an increase of $2.7 million or 15% over the prior year. This increase is primarily due to approximately $2.2 million in restructuring charges related to our U.K. operations. We remain focused on managing the growth in our general and administrative expenses. Moving on to earnings, for Q2, 2011 we generated net income of $14.2 million or $0.40 per basic share. This compares to net income of $9.8 million for Q2, 2010. Finally, let me briefly comment on the balance sheet. Our combined cash, cash equivalents, investments, and accounts receivables totaled $174.4 million as of June 30, 2011, compared to $210.4 million at December 31, 2010 and $155.2 million as of March 31, 2011. As we stated in our previous call this year, calendar 2011 is a year of execution. We look forward to completing deliveries of BioThrax under our current U.S. government contract as recently modified, and we look forward to commencing deliveries under the new follow-on multiyear contract in late 2011 or early 2012. We continue to make significant progress with the process of licensure and building 55 and the modifications to our Baltimore facility. We anticipate achieving important development milestones in many of our clinical development programs. We have also continued our focus on growing our business through M&A and are actively reviewing opportunities that would bring near-term value. That concludes my comments. I will now turn the call over to the operator so that we can begin the question-and-answer portion of the call. Operator, please proceed.

Nicolas Bishop, Analyst

Good evening, guys, thanks for taking my questions. The first one on your production yield. Fuad mentioned in his prepared remarks that over the last several years you put in place some process improvements that seemed to give confidence that you could reproduce, simply, get a higher production yield at the higher end of that range. Could you maybe explain a little bit exactly what went wrong in the last quarter, what your confidence is going forward that you can return to the higher end of the production and when that higher production might occur?

Fuad El-Hibri, Chairman and CEO

Thank you, Nick. Let me start by saying that really nothing went wrong as such in that second quarter. As we had advised previously, our output, annual output has reached a level from 7 million to 9 million doses a year and what we had anticipated as we prepared guidance early on this year is that we would somewhere between 8 million to 9 million doses this year. As it turns out, we are now producing closer to around 7 million doses a year. The variability in biologics manufacturing really has to do with growth characteristics of the fermentation process. There, it changes from time to time. Yes, the optimization activities that had been going on for a while have actually proven to have shifted our output ranges from what used to be in the lower millions to now 7 million to 9 million, and last year it was close to 9 million doses. This year, as it appears, we will be closer to 7 million, but our confidence that we can still operate within the 7 million to 9 million dose output range is high and that our optimization exercises will continue to enhance on average our annual output, hopefully someday bringing even shifting the upward range to something like 8 million to 10 million doses. So just reminded this year that it’s taking a little longer and that the fermentation process is inherently variable, and this year it appears that we’ll be closer to the lower range of that output.

Nicolas Bishop, Analyst

Okay, thanks, that’s helpful. And then the other thing I wanted to ask about is the finalization of the new contract. Do we have any updates on timing of that finalization and maybe just some color on what points are being negotiated at this stage and also, as I understand it, it’s a five-year contract with the number of doses such that you are obligated to deliver 8.8 million per year. So how should we think about what happens if your production capacity comes in sort of towards the lower end of the 7 million to 9 million in the future?

Fuad El-Hibri, Chairman and CEO

Now these are good questions, Nick. Let me start with the first one, which is what is our expectations as to signing of the new contract? There, we’ve been informed the document wants to still accomplish a signing by the end of the third quarter. We as recently as a couple of days ago continued negotiations; we’re making progress. We have no reason to believe that we couldn’t finalize a contract by the end of the third quarter, so in the next couple of months. With respect to the new contract, which would likely start with deliveries in 2012, is looking forward for five years and as you say has an average of about 8.75 million to 9 million doses. And as I mentioned earlier, based on not only last year’s approximately 9 million dose output, but the previous years, we’ve seen an improvement, an upward trend in output. We still believe, even though this year might be below expectations, that next year and the years beyond will generate an average of around 9 million doses upwards, so that we feel quite confident that we can deliver. Let me also remind you that as in previous contracts already signed that in this one we expect that we have a provision that allows us to deliver doses in any given year that we fall short of for the next year. So there will be a provision that we expect, as with other contracts, that would allow us to then deliver in the following quarter if we fall short because of the variability in our yields, and that can vary from year to year. But do we expect to be able to produce an average projecting forward over the next five years of 9 million doses? Yes, we do.

Cory Kasimov, Analyst

Hey, good afternoon, guys. Thanks for taking the question. To follow up on that last topic of discussion and ask it from the other side, what happens with the follow-on contract if the new manufacturing facility comes online in the next five years while that contract is ongoing, and you have substantially more capacity?

Fuad El-Hibri, Chairman and CEO

I understand, and we are working towards a timeline that we had communicated with you previously of completing the licensure of that facility within 3 to 4 years. Now there are a couple of variables that are unknown, such as to what extent we have to do clinical bridging studies, and that makes to drive it out to five years from now. I think the government wants to succeed, and so do we, and didn’t want to give us the runway to give us time to complete the Licensure of building 55. So I think we would see it very positively that the government was willing to commit itself, or it is willing to commit itself for five years in a five-year contract. Now should we get licensing of this building 55 facility that scales up facility earlier, this would be good news. We would take that opportunity to discuss it with the government and look at ways to accommodate the additional output.

Cory Kasimov, Analyst

Okay. And then you guys clearly sound confident about securing the new follow-on BioThrax contract this quarter, but I just want to make sure that the current macro issues that are out there aren’t a potential source of a delay beyond what your current expectations are?

Fuad El-Hibri, Chairman and CEO

I mean the country is going through hard times, there is no doubt, and there have been some identified spending cuts and there are some still to be identified through the special committee. National security and homeland security is a very important issue, and biological threats of specialty anthrax have been identified as the highest threat. The requirement of 75 million doses for the stockpile stands, and so there is no indication that there would be any cuts with respect to protecting American civilians from what’s still remains a high-risk potential threat.

Cory Kasimov, Analyst

Okay, that’s helpful. And my final question on a totally different subject. When do you expect to have Phase IIb, TB data, and if it’s positive, what would the next step be?

Fuad El-Hibri, Chairman and CEO

Yeah, that’s a good question. We will publish the results sometime next year. As you know, we will have some indications before we actually publish the final study results. But our next step would be to approach regulatory authorities to see if the powering of this particular trial, given the strength of the data that it generated, would be enough for licensure, for example, in South Africa and where the disease has ramped up and where there is a national emergency expressed around disease and the combination of HIV and TB. So of course, we will explore any opportunity of early licensure in South Africa and potentially some neighboring countries while continuing to move along the regulatory pathway in Europe and potentially the United States for this product to also be licensed.

Robert Burrows, VP, Investor Relations

Thank you. Ladies and gentlemen, that concludes today’s call. Thank you for your participation. Please note that today’s call has been recorded and a replay will be available beginning later today through August 15. Alternative readers available on the webcast of today’s call and our conference which will be available later today, accessible through the company’s website. Thank you again, and we look forward to speaking to all of you in the future. Goodbye.

Operator, Operator

Thank you for your participation in today’s conference. This concludes the presentation; you may now disconnect. Have a great day.