Good day, ladies and gentlemen, and welcome to the Second Quarter 2016 Emergent BioSolutions Earnings Conference Call. As a reminder, this conference call may be recorded. I would now like to turn the call over to Emergent BioSolutions. Please go ahead.

Thank you, Charlotte, good afternoon everyone. My name is Bob Burrows, Vice President of Investor Relations for Emergent. Thank you for joining us today as we discuss our financial and operational results for the second quarter and first six months of 2016. As is customary, our call today is open to all participants. In addition, the call is being recorded and is copyrighted by Emergent BioSolutions. Participating on the call with prepared comments will be Dan Abdun-Nabi, President and Chief Executive Officer and Bob Kramer, Executive Vice President and Chief Financial Officer. There will be a Q&A session at the conclusion of our prepared comments. Other members of senior management will be available to participate. Before we begin, I will remind everyone that during today's call, either on our prepared comments or the Q&A session, management may make projections and other forward-looking statements related to our business, future events, our prospects or 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. Please review our 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. During our prepared comments as well as during the Q&A session, we may also refer to certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding Emergent’s operating performance. Please refer to the tables found in today’s press release regarding our use of adjusted net income, EBITDA and adjusted EBITDA and the reconciliations between our GAAP financial measures and these non-GAAP financial measures. For the benefit of those who may be listening to the replay of the webcast, this call was held and recorded on August 04, 2016. Since then, Emergent may have made announcements related 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 regulation. Today’s press release may be found on the Investors home page of our website. And with that introduction, I would now like to turn the call over to Dan Abdun-Nabi, Emergent BioSolutions' President and CEO. Dan?

Well, thank you, Bob. Good afternoon everyone and thank you for joining us. So during the call today I'll give an overview of our second quarter financial results and then provide an update on our recent business accomplishments. Following my prepared comments, Bob Kramer will finish with a more detailed discussion of our financial performance. So let me start with a brief summary of our financial results. Total revenues for the quarter were $101 million bringing our 2016 revenue to $212 million. GAAP net loss for the second quarter was $10.9 million and adjusted net loss was $7.1 million. As announced during our last call and again in the press release today, due to the lack of clarity on the current and potential new HHS contracts, we will continue to temporarily postpone our financial guidance for 2016. Now let me highlight a few of our key business achievements so far this year. Earlier this week we announced completing the spin-off of Aptevo Therapeutics. I’d like to thank all the employees at Emergent and Aptevo for all of their hard work in achieving this significant milestone. We wish everyone and Aptevo our best wishes for their future success. So with the spin-off complete, we are now better positioned as a pure-play company recognized as a leader in the public health threats and emerging infectious disease fields. The spin-off also contributes to improving our cash flow from operations through the elimination of Aptevo-related R&D, sales and marketing and G&A costs. Importantly this spin also provides greater flexibility in our capital allocation decisions. Along these lines, last month we announced that our Board of Directors authorized management to implement a stock repurchase program of up to $50 million of our common stock. This gives us an opportunity to create long-term shareholder value while maintaining our financial flexibility to invest in our business and to continue to pursue our acquisition strategy. Now we’ll discuss where we stand with our US government contracts. As we’ve previously reported by letter dated April 26, 2016, the CDC indicated that it anticipates that the quantity of BioThrax it plans to purchase for the remaining term of the existing contract will be less than the total remaining doses available to be purchased. The CDC also advised us that their intent to purchase additional doses of BioThrax in the second and third quarters. Consistent with that advice, the CDC did purchase BioThrax in the second quarter, now leaving 4.2 million doses available for purchase under the current contract with a value of approximately $122 million. The CDC has not specified how much of this remaining quantity they intend to purchase. On June 21, 2016, the U.S. Department of Health and Human Services issued two solicitation notices with respect to the development and procurement of anthrax vaccines for the Strategic National Stockpile. First, HHS issued a sole-source notification indicating its intention to award Emergent a contract for the purchase of 29.4 million doses of BioThrax by September 23, 2016, with a period of performance of five years. This solicitation does not state their number of doses to be procured per year nor does it specify a price per dose. So the next steps in this process are for the CDC to publish a fee for this procurement and following that Emergent will submit its proposal to the CDC for consideration. Finally, the parties will endeavor to finalize the contract by CDC's targeted completion date of September 23. The second solicitation issued by HHS includes an RFP seeking a next-generation anthrax vaccine for post-exposure prophylaxis with the ability to confer protection in one or two doses and meeting additional specific criteria relating to safety, efficacy, and manufacturing. The contract is for the development of the vaccine candidate to licensure as well as for the purchase and delivery of an initial 2 million doses to the SNS, with potential additional procurement of 12 million doses up to 25 million dose regimens as a final world-class. HHS has confirmed that this equates to 50 million doses of anthrax. Earlier today we responded to the RFP so the next steps in this process are for HHS to determine if anthrax will be selected for contract negotiations and if selected Emergent and HHS will endeavor to finalize the contract. HHS stated in the solicitation notice a target completion date of August/September. While there could be no assurance that HHS will select anthrax, we believe that anthrax is well positioned and distinctively suited to satisfy all the stated requirements in the RFP. We are not aware of any other vaccine candidate that meets all those minimum requirements. The timing and the requirements described in the two HHS solicitations aligned with the anticipated licensure of our new large-scale manufacturing facility Building 55, where we expect to manufacture both BioThrax and anthrax. In June, the FDA both accepted our sBLA and completed their pre-approval inspection of Building 55. At the end of that inspection, we received no observations from the FDA inspectors. With these two critical milestones successfully completed, the sBLA now has the PDUFA target date of August 15. Importantly, we are now in the process of ramping up our production in Building 55 to facilitate a seamless transition to large-scale manufacturing. In summary, we continue to believe that taken together, these two solicitations supported by the anticipated timing of Building 55 approval represent the government's plan to transition from BioThrax to NuThrax. Moreover, based on the procurement levels specified in the HHS solicitations, we believe the government is continuing to drive for the capability of protecting 25 million people from the threat of anthrax. And that concludes my prepared comments. And I will now turn the call over to Bob Kramer for details on our financial performance.

Thank you, Dan and good afternoon everyone. Thank you for joining our call. I'll keep my comments on our quarterly financial performance brief, as our press release and 10-Q to be filed by the end of this week provide the details of the financial metrics for the quarter and year-to-date periods compared to last year. Q2 revenue, although $101 million, was $25 million below last year. The shortfall was attributable to lower BioThrax shipments consistent with CDC’s communication to us earlier this year in April that they intend to procure less than the total remaining doses under the existing contract. As Dan discussed earlier, the near-term uncertainty around the level of BioThrax shipments both for the remainder of existing contract or Q3, as well as under the follow-on contract or Q4, have together resulted in the continued need to temporarily postpone guidance. We expect to receive additional clarity upon completion of the contract negotiations and we will be sharing that with you as soon as practical. While uncertainty remains in the short term for BioThrax shipments and revenue, the fundamentals for our business remain very healthy. I'm going to comment on just a few examples. First, our net R&D costs continued to be managed carefully and as a result, continued the favorable trend started two years ago following our decision to look for non-dilutive funding and collaboration opportunities for some of our development assets. Year-to-date net R&D expenses were $5 million, less than half of what they were in the same period in 2015. Further to this point, on a trailing 12-month basis, our net R&D at the end of Q2 of 2016 was $25 million, significantly below the $63 million trailing 12-month net R&D expense totaled at the end of Q2 of 2014. Secondly, the business continues to generate positive cash flows. As of Q2, 2016, our balance sheet includes $333 million in cash, an increase of $21 million compared to year-end 2015. And while $45 million of this was used to partially capitalize the spin-off of the Aptevo Therapeutics earlier this week, we continue to have sufficient capital to support the execution of our growth strategy, a component which is to have greater flexibility in how we allocate capital. As previously announced, our Board authorized management to implement a stock repurchase program of up to $50 million of our common stock over the course of the next 15 months through the end of 2017. Lastly, the performance of our manufacturing operations continues to strengthen. The most recent evidence being the initiation of the transition of BioThrax manufacturing from our current facility to Building 55. The transition is underway, advancing the anticipation of a mid-August approval by the FDA. That concludes my prepared remarks and I’ll now turn the call over to the operator to begin the question and answer session for this afternoon.

Our first question comes from Jessica Fye from JPMorgan. Your line is now open.

Hi there, thanks for taking my questions. Very few, the first one is around NuThrax. I want to make sure I understand at what point we’ll get clarity on whether or not that is the anthrax vaccine that the government ultimately transitions to and not to move the other candidates in development. Is that a - and you mentioned there could be feedback in the near term, will that be definitive or is sort of a longer-term decision that the government is making? The second question is around guidance, wondering if it’s possible for you to give any color at least on the expense side which is within your control just in light of the spin and kind of a lot of moving pieces and maybe I’ll stop there. Thanks.

Yes, thank you so much Jessica for participating and for the questions. So with respect to NuThrax, the process is pretty clear. The RFP is out, there is a deadline for submitting responses and that deadline is tomorrow. As I mentioned earlier, we have submitted our response today and the government, the process by which they complete this is they evaluate the submissions and then make a determination as to whether any of the candidates that have been submitted meet the requirements and they make a selection for contract negotiation and then the parties engage in those contract negotiations. This is near term. The way the government has described it, they have a desire and intend to complete it within the August-September timeframe this year. We believe that’s around utilization of funding in this fiscal year. Having said that, the answer to your question is this is not a long-term drawn-out process. We will fairly quickly know if NuThrax is selected and what the terms of that contract will be, and then fully expect to issue a release to advise the market when the contract is completed if we are selected. So hopefully that answers your question on the NuThrax front. Bob I’ll turn it over to you on the guidance and the expense guidance.

Sure, thanks for the question. On the OpEx side, I think you should expect that you’ll continue to follow the trends in our spending pattern as we reported for the last trailing 12 months, that those trends will continue. Obviously as we've reported and included in our reconciliation between GAAP and adjusted net income, we’ve incurred some expenses related to the spin which as of August 1 is completed, so those expenses should begin to trail off but I wouldn’t expect any significant changes in the semi-parallel versus what we reported.

Okay, got it. Thank you.

Thank you. Our next question comes from the line of Jim Molloy from Laidlaw. Your line is now open.

Hi, thanks for taking my questions. I was wondering – I know the buyback that are just announced, have any purchases started on that yet or any idea what the timing might be? And then on the next-gen vaccine, it’s kind of a two-part question, do you know of other people who have submitted RFPs for that and what do you do with those who defy this - if they don’t select NuThrax?

So some great questions there, thanks for participating and thank you for putting those out there. So first on the buyback, as we previously announced, we intend to implement that buyback pursuant to a 10b5-1 program so there are some legal requirements associated with putting that in place. We expect the plan could be put in place sometime starting in September so the initial purchases would happen earliest in the timeframe in compliance with those legal requirements, so hopefully that gives you some clarity around the process and the timeline for that. So with respect to NuThrax, we are not aware of any other product that meets the minimum requirements specified in the RFP other than NuThrax. And there are manufacturing requirements, there are dosing requirements, efficacy and safety requirements, clinical trial requirements. So our belief is that NuThrax is very well-positioned. I can't tell you if anybody else submitted, we don’t have this ability into that; only HHS would know. So, but I remain very bullish about NuThrax opportunity given the qualifications of NuThrax as measured up against the minimum requirements. So in terms of manufacturing in Building 55, the predominant manufacturing activities over the course of the next several years really will be BioThrax. NuThrax manufacturing is true will be conducted in Building 55 but over the near term it’s really BioThrax that will be direct primarily in Building 55 for the manufacturing purposes.

Thank you. And you had mentioned in the past or discussed the assumption that perhaps there would be a much larger order for BioThrax that's certainly changed now and with that large order pricing coming down. Can you speak to what pricing looks like here on BioThrax before NuThrax comes in and what will happen should we complete this next BioThrax contract and NuThrax is still really good? Do you anticipate the US government will come back for more BioThrax until NuThrax will be ready??

Yes. So there's a lot of speculation in the questions that you asked. What I would say as a principal we have in our communications with the government that provided clarity that long-term contracts for large quantities do justify price reductions. I think the reverse is also true. So as I stated in my prepared remarks, Jim, there is no specification in the solicitation regarding the delivery schedule or the price reduction. All of that remains to be negotiated. So while I appreciate there’s some uncertainty here, I think we all need to be a little bit patient, and allow us to work through this process with the US government on both contracts. And in the September timeframe, if you keep according to the schedule that specifies, we will have much greater clarity for the investors to see exactly where this is heading.

Great. Last question then, in the past you've spoken about ex-US sales in Germany potentially approving Building 55 even before the US government does. Can you talk a little bit about where you might do access Building 55 capacity or ex-US sales of potential near-term possibility? And then lastly, what you’re seeing out there, what’s looking most compelling for acquisitions at this juncture? Thank you.

Sure. Let's begin with the international market. As you know, we have been limited in capacity with Building 12, and we've been supplying everything produced at that facility to the government under our current contract. We are working on Building 55 to increase capacity, which will also raise the availability of anthrax doses for international markets. However, we have consistently indicated that the demand for BioThrax from HHS in the U.S. far exceeds that of international markets. We do not view the international market as being on par with the U.S. market. When considering international opportunities, we take a portfolio approach and expect some sales of BioThrax. I encourage you to think more broadly, particularly about Emergard, where we've seen significant interest, as well as other products built on that platform like RSDL. We approach international markets as a portfolio and, as we mentioned in relation to our 2020 goals, we aim for 10% of revenues to come from international sales. With the expanding portfolio available to us and the ongoing development or acquisition of additional products, we believe we can make progress toward our 10% target. So, it’s important to view this not just in terms of BioThrax; our diversified business is enhancing our international opportunities. Regarding acquisitions, we are actively identifying and negotiating for those that align with our early criteria. We prioritize revenue-generating opportunities that can positively impact our business within a year. There are intriguing opportunities out there, and we are targeting a deal announcement within this year in 2016.

Great, thanks for taking the questions.

Thank you. Our next question comes from the line of David Meyers from Wells Fargo Securities. Your line is now open.

My questions have been asked and answered. Thank you.

Welcome. Thanks for joining.

Thank you. Our next question comes from the line of Eric Schmidt from Cowen and Company. Your line is now open.

Thanks for taking my questions. Just in terms of Building 55, given this throughput might be down from where you had expected to be. Can you talk about how that impacts gross margins or maybe since the price yet? How the price put those manufactured might compare to Building 12?

Hi, Eric, this is Bob. Thanks for the call, the question. So as we’ve talked about and obviously Building 55 was always intended for large scale manufacturing. It’s an extremely efficient building. And as we’ve talked about in the past, we anticipate being able to leverage the efficiencies and as Dan indicated earlier, yes, the government is interested in long-term significant quantity purchases. We’re willing to be aggressive on pricing. We’ll have to see how this all settles out with the follow-on contract, both procurement as well as development contract and when we reinitiate guidance all of I think the answers to your questions will be baked into that. But right now, it’s just premature to speculate on pricing and margins until we have those contracts negotiated.

Okay. In terms of the potential next generation NuThrax contract and the selection process, it hopes to wrap up in the August/September timeframe. At that point in time, would we know the size of the subsequent procurement contract or would it just be explicitly a development contract?

Yes. So great question, Eric. The way it’s structured in the RFP is the development as well as the procurement as part of the base and I think the initial dose quantities and so a few million doses with options to procure 12 million, up to 25 million dose regimens. And the dose regimen is the number of doses in order to protect an individual. So for NuThrax, it’s a two dose schedule, so that would be 50 million. So the way the contract is structured is development plus a preliminary procurement and then options for additional procurement in that 12 million to 25 million dose range.

So we’ll know the price for the initial 2 million, but not necessarily the subsequent 25, is that right?

That remains to be seen as part of the negotiations.

Okay. And one last question. So of course, NuThrax is accepted or selected for this contract, what’s the soonest possible date you think is that the drug, the vaccine, excuse me, could be approved?

As soon as data could be approved or available for purchase, so I’m not sure you talk about approval?

Sure. However, you want to ensure it's available for purchase?

Yes. So as you know, there is this emergency use authorization process that’s available for products that are in advance development. And so we would anticipate within the next two to three years, the product could be available for purchase under emergency use authorization. The approval timeline of course, is beyond that.

Any sense of the approval timeline?

Yes. I think, the answer to that is we need to work that through with the government before we can give firm timelines within the plan.

Thank you.

Thank you. Our next question comes from the line of Keay Nakae from Chardan. Your line is now open.

Yes, thanks. Just want to go back to the comments you made regarding the operating expense going forward. We can see what we were allocating to Aptevo, so no longer having that allocation, is that simply going to be allocated to other projects and if so, what?

Well, certainly thanks for the question. This is Bob. Certainly the research and the development expenses that we’ve reported that are attributable to the biosciences division, those obviously will no longer be incurred by Emergent after August 1. However, if you’re referring to the SG&A expenses and some of the other related costs, I wouldn’t look at it as a straight elimination based on how those have been allocated or broken up between the two divisions. Again, as soon as we work our way through these contract negotiations, we will come out with some updated guidance, which will incorporate the spending patterns going forward.

Okay. And then second question. Once you’re able to produce products in Building 55, is that going to be a complete switchover notwithstanding what the cost of goods sold might be at initially lower volumes than expected?

I think the plan is to do a complete switchover for a host of reasons around why Building 55 is so much more effective, efficient, and favorable. So yes, it’ll be to a complete switchover.

And then just timing on that, you’re doing some prep work now. You’ve got to produce a day coming up to a very shortly, how quickly does finished product come off the line?

That’s why I think we are right now in the process of making that transition. So we see that as a very near-term transition from Building 12 to Building 55.

Okay, very good. That’s all I have thanks.

Thank you. Our next question comes from the line of Robert Maltbie from Singular Research. Your line is now open.

Hi, any developments on the initiatives with Zika and second question regarding the impact on your EBITDA from the spin-off of Aptevo? What are you looking there moving ahead?

Okay. Let me start with Zika and I’m actually going to ask Adam Havey, President of the Bio Defense division to address that. As you know, it’s in our Baltimore site, our ADM site. Adam?

Sure. Thanks for the question. So basically at this point, we’ve been awarded, I think the only government contract related to Zika, and we’re working very closely with part at Zika vaccine with some technology that they provided to us. And over the next year, we’re going to be doing some process development work, manufacturing vaccine would be able to be tested in a Phase I study. So we’re excited about that technology and will be reporting leveraging that ADM contact in the facility.

And Robert, this is Bob, regarding the EBITDA question. When we announced the intent to spin off the Biosciences business back on August 6, 2015, we included a summary page detailing that if the spin had been in place for the entire calendar year of 2014, we projected an EBITDA increase of between $40 million and $50 million, considering the revenue associated with Aptevo and the cost savings in R&D and SG&A. Additionally, when we reported our EBITDA for 2015, it was $130 million. The initial guidance we provided for 2016, which has now been postponed, was around $115 million, reflecting half a year of EBITDA improvement due to the spin. These are a couple of data points to keep in mind as you consider the question. As we look to resume guidance at the appropriate time, we will factor in our current projections for EBITDA savings resulting from the spin.

Thank you, Bob.

Thank you. Our next question comes from the line of Jessica Fye from JPMorgan. Your line is now open.

Hi guys, thanks for taking the follow-up. Just had a quick one more modeling question, not to go back to the guidance, but when you originally provided your guidance in January, I don’t think you gave specific other Biodefense guide, but given the BioThrax range and the overall revenues, you go back into something that looks like it was a little bit higher than where you are tracking to right now. Can you talk about your expectations for that part of the business for the remainder of the year, given that it’s not really subject to this anthrax vaccine contract issue? Thanks.

Sure Jessica. Thanks, again, for the question. We’re going to resist parsing out of partial guidance here on BioThrax as well as the other Biodefense. Again, I think we would ask that you be a bit patient. We expect to be able to work through these contract negotiations and discussions between now and the end of September. And when we reinitiate guidance it will incorporate all of the current thinking on all of the parts of business but for now, we’re not going to discuss or even give any partial guidance on these parts of the business.

Okay, thanks.

Our next question comes from Eric Schmidt from Cowen and Company. Your line is now open.

Thanks for my follow-ups as well. I guess, first, just on the coming quarter, don’t you already know in advance that you’re scheduled certain BioThrax deliveries maybe even now for the next two months? And can you just use that as a basis for giving a sense of how many of these 4.2 million doses will be delivered?

Yes, thank you for the follow-up, Eric. We currently lack the visibility to provide meaningful guidance to you and the others on the call. It's important for us to be patient and allow us the time to work through this. As we approach completion and finalize these contracts, we will be in a much better position to offer the guidance you need. At this moment, we simply do not have sufficient data to provide the necessary guidance.

Okay, fair enough. Maybe just on the stock repurchase Dan, and not trying to be cheeky here, but you do have a lot of things that are up in the air that you're hoping to get visibility on over the next two or three months, yet you're moving forward with the stock repurchase plan. What gives you confidence that your stock is undervalued or that this is a good investment at this point in time?

Yes, no that’s a good question and I don’t think, it’s cheeky at all Eric. So thanks for bringing it up. And the way I look at this and you’ve been with the company, you have been following the company for a while. These transitions with the government have always been difficult; you probably remember the last one, it was in very difficult negotiations. And in leading up to this, I think, in the quarterly calls we had, I put out there that this is also going to be a difficult negotiation and it’s further complicated by the transition as we see it. So my belief is that the government remains firmly committed to the Anthrax space. They are continuing to target that 25 million lives; BioThrax is the only available and licensed countermeasure by way of vaccines, both on Gov and prep indication. NuThrax is the leading next-generation candidate in the queue having passed a lot of the tests. So we do have a great deal of confidence, given the fact that we’ve been partnering with the government, both on the development side and the procurement side, including when we think of development, the completion of the Building 55 scale-up for the desired purpose of having additional capacity to address the Anthrax threat. So there are a number of indicators out there. You can look at the dose requirements or the specifications of doses in the NuThrax contract and prior statements by the government. So we have and I personally have a high degree of confidence that this is absolutely the right move for the organization and that with the passage of time, we will have much better clarity to share with you on where things stand with both NuThrax and BioThrax. So again, I appreciate the comment and the question. I think, it’s spot on, but given our assessment of the landscape, we think this is the right move for the organization.

Thank you.

Thank you. I’m not showing any further questions at this time. I would now like to turn the call back over to Bob Burrows for closing remarks.

Thank you, Charlotte. With that, ladies and gentlemen, we now conclude the call and thank you for your participation. Please note, an archived version of the webcast of today’s call will be available later today and accessible through the company website. Thank you, again. We look forward to speaking with all of you in the future. Good bye.

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program. And you may all disconnect. Everyone, have a great day.