Robert Burrows - VP, Investor Relations Daniel Abdun-Nabi - President and CEO Adam Havey - EVP and President, Biodefense Division Barry Labinger - EVP and President, Biosciences Division Robert G. Kramer - EVP, CFO and Treasurer.

Marc Frahm - Cowen & Company.

Good day, ladies and gentlemen, and welcome to the Emergent BioSolutions First Quarter 2015 Financial Results Conference Call. At this time all participants are in listen-only mode. Later we will be conduct a question-and-answer session and instructions will follow at that time [Operator Instructions]. As a reminder this call is being recorded.

I would now like to turn the call over to Emergent BioSolutions. Please go ahead..

Thank you, Mally. Good afternoon everyone. My name is Robert Burrows, Vice President of Investor Relations for Emergent. Thank you for joining us today as we discuss our financial results for the first quarter of 2015 and our outlook for the second quarter and full year of 2015. 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.

Following Dan and Bob’s prepared comments we will conduct a Q&A session at which time other members of senior management will be available to participate, specifically Adam Havey, Executive Vice President and President of our BioDefense Division; and Barry Labinger, Executive Vice President and President of our BioSciences Division.

Before we begin I will remind everyone that during today’s call, either in 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 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.

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 or the Q&A session we also may 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 loss, adjusted net income, EBITDA, and adjusted EBITDA and a reconciliation between these non-GAAP financial measures and our 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 7 May, 2015. 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 the Investors home page of our website.

With that introduction, I would now like to turn the call over to Dan Abdun-Nabi, Emergent BioSolutions' President and CEO.

Dan?.

Thank you Bob. Good afternoon everyone and thank you for joining our call. During the call today I’ll highlight some of our recent business achievements, and then Bob Kramer will finish with a discussion on our financial performance. I’ll start with the discussion of our BioDefense division.

As you might recall on January 28 during standard quality inspections performed in accordance with customary procedures the company discovered foreign particles in a limited number of vials in two manufactured lots of BioThrax.

In order to determine the source of these particles, the company began an investigation into its operations as well as those of its suppliers and contract manufacturers. On April 22nd we announced the completion of this internal investigation. Following a comprehensive assessment we identified a supplier component as a most probable root cause.

As a result we are implementing certain targeted corrective and preventive actions in the operations of our suppliers and contract manufacturers as well as in our own operations.

The investigation concluded that there was no impact to any BioThrax loss in distribution or to any of our other products or manufacturing operations including Building 55 operations and plans for licensure.

With the conclusion of this investigation we reaffirmed our financial outlook for full year 2015 which includes the full impact of all decisions on BioThrax lot disposition. Now that we have resume full manufacturing operations BioThrax lots are being released and scheduled for delivery this quarter.

The downtime that occurred during our internal investigation has resulted in an approximate 90 day lag in delivery and we expect deliveries to be caught up by the end of the third quarter. Now let me give you an update on Building 55, our large scale BioThrax manufacturing facility.

During our last call I mentioned that we would be meeting with the FDA to discussion our SBOA filing strategy. We have had ongoing dialog with the FDA about submitting our SBOA in phases with the final submission being the pivotal non-clinical final study report.

This pivotal study is complete and primary end points were met as we announced on February 13th, with the only remaining deliverable being the final study report. This report is targeted for completion in Q4 and is progressing on time.

Given our current status and although the schedule is tight we continue to target regulatory approval of Building 55 in early 2016. Moving to our BioDefense portfolio in March we received FDA approval of ANTHRASIL that the treatment of inhalational anthrax in combination with appropriate antibiotics.

Achievement of this milestone triggered a $7 million payment to the company under development contract with BARDA. ANTHRASIL has received Orphan Drug Designation and as a result of this approval the product qualifies for seven years of market exclusivity.

As the only FDA approved polyclonal therapeutic for the treatment of anthrax disease ANTHRASIL becomes the fifth approved product in our growing BioDefense portfolio and continues to be an important part of the U.S. government strategic national stockpile. Next let me update you on our latest Ebola efforts.

On March 16th we announced collaborations with Oxford University, GlaxoSmithKline and the NIAID. Until the agreement signed with these organizations we manufactured an MVA Ebola vaccine candidate for use in a Phase I clinical study.

This clinical trial is being supported by a grant from the Wellcome Trust and the UK deployment of International Development. The study will evaluate the safety of the vaccine as a heterologous boost to GSK’s Chimp Adenovirus type 3 Ebola vaccine candidate.

We manufacture this vaccine candidate at our Bayview Campus, in Baltimore, Maryland using our proprietary MVHF technologies and capabilities.

That facility has been designated by HHS as one of three centers for innovation and advance development and manufacturing and is designed for search manufacturing of medical countermeasures to address public health threats. We look forward to announcing the initiation of the Phase I trial shortly.

As we have discussed in numerous calls over the past years we are committed to organic growth to sales of our BioDefense portfolio internationally. Our strategy involves a two pronged approach that we are employing in parallel.

The first approach is direct sales to government agencies and on this front in the fourth quarter of last year we had our first significant ex-U.S. hyperimmune product sale from our portfolio.

And during the first quarter of this year we have submitted multiple proposals for individual products as well as counter measure packages for chemical and biological threats. The other approach that we are employing to international sales is through the European joint procurement mechanism or JPM which is adopted through EUI legislation in 2013.

The JPM is a voluntary system that enables any of the 28 EU member states to pool their demands and procure pandemic vaccines and other medical counter measures against cross border CBRN health threats.

We see this as the European Union’s recognition of the importance of creating and maintaining stock files of CBRN medical counter measures and as an effective mechanism for expanding the presence of our BioDefense products in Europe. Based on these two approaches we expect to see significant growth in ex-U.S. sales across our BioDefense portfolio.

Shifting over to the BioSciences Division last week we announced FDA approved IXINITY, a treatment of Hemophilia B in adults and teenagers. With this approval we are very pleased to be able to our patients and healthcare providers an additional choice to better manage this disease. We expect IXINITY to available to patients by the end of this quarter.

We have also been making progress with our most advanced ADAPTIR platform candidate, ES414 for patients with prostate cancer. As part of the immunoncology space our ADAPTIR platform is a proprietary redirected T-cell cytotoxicity or ITCC approach to treating cancer.

We partnered ES414 with MorphoSys at the end of 2014 and in March we announced the initiation of the Phase 1 study to evaluate the safety, tolerability and critical activity of the product. The initiation of this study triggered a $5 million payment to the company by MorphoSys.

We look forward to clinical data from the study and also working towards additional partnerships along other product candidates based on our ADAPTIR platform.

So operationally we had a very productive start to the year already achieving three of our 2015 goals including securing Anthrasil approval, initiating the Phase 1 trial for ES414 and launching IXINITY.

We also remain well positioned and on-track to deliver on our remaining 2015 goals including finalizing the SPOA submission for Building 55, securing a post exposure prophylaxis access indication for BioThrax, completing a strategic acquisition that aligns with our core competencies and supports our growth bank and announcing our next multiyear growth plan in the second-half of 2015.

That concludes my prepared remarks and I will now turn over to Bob Kramer for details on our financial performance.

Bob?.

Thank you, Dan and good afternoon to everyone on the call. I would first like to make some general comments our financial results for the first quarter of 2015 compared to last year.

I will also comment on the balance sheet focusing on our cash position then I will finish up with details related to our 2015 forecast, including our thoughts on Q2 revenue guidance as well as the implications for revenues and net income for the second-half of 2015.

For the first quarter total revenues were $63.6 million or $9.7 million above Q1 of last year, representing an 18% improvement.

The increase in revenue is primarily due to modest organic growth in sources of revenue other than BioThrax as well as the impact of having the former Cangene operations consolidated with the Emergent for the full quarter of this year.

As you know during the quarter we made no shipments of BioThrax to the CDC due to the investigation, which had a significant impact on our overall financial results for the period. As a point of comparison in Q1 of 2014 we recorded $24.5 million of BioThrax revenues.

As expected the gross margin on consolidated product and CMO revenue for the quarter of 39% is below the normal range of 60% to 70%, again to due to the lack of BioThrax shipments during the period.

As we progress through the remainder of the year and as we return to normal shipment schedules for BioThrax we anticipate gross margin in future periods to be well within the normal range, reflecting the significant profit contribution of BioThrax.

Gross, research and development spend for the quarter was $38.7 million, $8.4 million higher than prior year, taking into account the offsetting effects of our contracts, grants and collaborations revenue our net R&D spend for the quarter was $5.6 million versus $14.9 million last year.

SG&A was higher year-over-year by $4 million due primarily due to the additional costs associated with Cangene operations we acquired in late February of last year.

As experienced in recent years our first quarter financial results typically results in a loss due to the BioThrax delivery schedule and the timing of our annual maintenance shut down activities for our facilities.

For the quarter we realized a GAAP net loss of $21.5 million or $0.57 per share versus $20.2 million loss or $0.55 per share loss in the same quarter as last year. On an adjusted basis the net loss was $18.8 million or $0.48 per share versus $14.6 million or $0.37 per share in 2014.

In addition EBITDA for the first quarter was negative $19.6 million or $0.52 per diluted share and adjusted EBITDA for the period was negative $18.4 million or $0.50 per diluted share, once again reflecting the impact of zero BioThrax shipments during the quarter.

Finally at quarter end our balance sheet continued to reflect a very strong capital position highlighted by our cash balance of $216 million, the third largest quarter end balance in our history.

The reduction in our cash balance from year end 2014 was a result of having no BioThrax shipments as well as capital investments, as well as payments of taxes and bonuses during the first quarter. Our financial strength positions us to continue to execute on our growth plan including targeted acquisitions.

Overall our operational performance is very strong during the first quarter despite the 90 day interruption in formulation and fill/finish operations related to BioThrax and we remain confident in our ability to make up for that interruption and still produce financial results in line with our original guidance.

This confidence is based on a number of factors. First we see the net effect of the interruption to be essentially a compression into the remaining three quarters of 2015 of our original forecast for BioThrax shipments for the entire year.

Shipments that were originally planned for Q1 are now projected to be shipped in Q2 and Q3 and as Dan stated we expect to be caught up with planned BioThrax shipments by the end of the third quarter. In years past the second half of the year has accounted for approximately 60% of BioThrax annual shipments.

Due to the 90 day interruption we now anticipate that the second half of the year will account for nearly 80% of BioThrax sales during 2015. Second as of today we are eight months into the BioThrax production year and we’re able to sustain high levels of sub lot manufacturing without interruption through the investigation period.

Third, our sub lot manufacturing success rate has been strong over sustained period of time and fourth full manufacturing operations for BioThrax, including the key downstream steps of formulation and fill/finish have now resumed.

Accordingly we are reaffirming our forecast for total revenues of between $510 million and $540 million for the year including between $270 million and $285 million of BioThrax product sales and net income between $50 million and $60 million on a GAAP basis and between $60 million and $70 million on an adjusted basis.

We are also forecasting Q2 2015 total revenues of between $105 million and $120 million. That concludes my remarks and I will now turn the call back over to the operator to take your questions.

Operator?.

Thank you. [Operator Instructions]. Our first question comes from the line of Jim Alloy with Levon Company [ph]. Your line is open please go ahead. Jim please check your mute button..

Hi, thanks for taking the question. I was on mute. Thanks for - well done again on the manufacturing these results so quickly Adam, I think and everyone there deserves a well done on that.

Could you walk a little bit through how you can ensure it won’t happen again obviously and is there a way to, I know that when you made the Cangene acquisition you brought in a fill/finish capacity at that point, would you move BioThrax into that fill/finish to try to avoid this issues going forward?.

Okay thanks Jim, thanks for participating on the call today and thanks for the recognition of the team’s effort. It really was a very significant effort and I am very proud of what they have accomplished over the past two to three months, so I appreciate your commentary there.

So as you might appreciate the team took a very detailed approach to the investigation. We evaluated numerous potential vectors for how this contaminant or particulate got into the system.

We looked at our own operation, we looked at contract manufacturers, we looked at suppliers and we identified, I think various ways that we can improve the controls around the system, not only at the suppliers and CMOs but also within our own operations.

And I think I said in the prepared comments we are now instituting some corrective and preventive actions, which we think are quite robust and very broad in scope but overall I think will improve the operation. So we have a high degree confidence that this truly is behind us.

Of course we have to continue the operations to validate that what we have done demonstrates what our belief is but we do remain highly confident in terms of the actions that we’re putting in place.

In terms of the fill/finish Adam do you want to talk about our plans for migrating fill/finish?.

Yeah, certainly. So I think as a result of the investigation Jim as Dan mentioned it was kind of a tiered approach and a very detailed approach. So we’ve always since the acquisition of Cangene planned to and it was one of synergies that we evaluated as we purchased Cangene to move BioThrax fill/finish into the Cangene facility.

So that’s something that we are actively working on and are pursuing and something you are going to see and we’ll probably about as we get closer to approval, but we’re actively pursuing that and we think that’s a real important step in our kind of vertical integration, if you will, of our supply chain..

Okay, great. Maybe a quick follow-up and then I will go back in the queue, congrats on certainly getting into - sitting on a pile of cash.

Obviously is there a better acquisition than having it sit in the bank or additional acquisitions happening, any new products to slot into the Cangene hospital sales force, any comment you can make on timing of something like that?.

Thanks, Jim. As you know we have a very robust business development process here evaluating any number of candidates both on the BioDefense and the BioSciences side and the cash is a critical component of our ability to execute on accretive and meaningful acquisition targets.

And those targets are in various stages of evaluation, some are early some got a bit more advanced.

Our expectation and our goal for the year, as I mentioned, is to complete an acquisition that can be consisted with our growth plan in terms of revenue generator, provide value to the organization whereby we can exercise some of our core competencies and create value which is greater in our hands than in the hands of the seller.

So we remain targeted for doing an acquisition at least one, BioSciences and/or BioD and the target is sometime during the course of this year so stay tuned on that..

Great, thank you for taking the questions..

Thank you. And our next question comes from the line of Marc Frahm with Cowen & Company. Your line is open. Please go ahead..

Hi, thanks for taking my questions and reiterate congratulations on quickly putting the production issues behind you.

When you did go through this investigation what were the communications with the FDA and has the FDA signed off on whatever changes you are making?.

Yeah, thanks for participating on the call and thank you also for recognizing the team’s efforts. Yes, we were in close contract with the FDA we advise them of the identification of the particles and what we were doing as a result of it. We also communicated with the FDA on completion of the investigation.

We did show a copy of our investigation report to them in order to release product. As you know the FDA releases every lot that we produce.

So we are now in standard release mode with them where they are evaluating lots that we produce and going through their lot release protocol and so lots are being released and we are now expecting to deliver as you heard with respect to our Q2 forecast BioThrax slots beginning this quarter..

Okay, thanks.

And then you have kind of alluded to this in talk of the acquisition, you have the long-term goals and at one point you talked about having a new long-term goals being announced maybe in the middle of the year and I guess maybe that took a back seat to the investigation but is there a timeline for that and then along the same line now that you are starting to having some BioDefense sales outside of the U.S.

do you have a little better of a feel for what’s Building 55 comes online what is the demand out there for BioThrax is?.

Yeah, so in terms of our next growth plan strategy and getting that out to the market for people to understand where we are headed going forward we are planning to announce that in the second-half of the year.

It is pretty advanced in this development we are iterating with the Board but our target remains getting something out to the shareholders and the investment community in the second-half of the year, so stay tuned on that.

In terms of international markets and B 55 and all of that our first priority as you might expect is addressing the unmet need but the U.S. government there is a 75 million dose stockpile deployment we estimated somewhere around 30 million doses right now that is our estimate official estimate.

So our first priority is to complete intervention with the CBC to address that stock deployment and to the extent that there is additional capacity within 55 after meeting the U.S. government needs and we will start to address the international market.

So I am going to say it is too early to give any assessment on that but suffice to say that we are keenly focused on being in position to supply at 55 and provide all customers with product that we can produce there..

Okay, thank you..

I think the other comment that your question raises is the other BioDefense products from international markets on overseeing is a growing recognition the value of the portfolio that we have the hyper immunes the device et cetera and I think an acceptation of the importance and the international markets have having stockpiles and the JPM the joint procurement mechanism that we saw in Europe I think is a clear manifestation of that desire and intend and collective resources of the European union, allow them to advance together to establish those counter stockpiles and we are seeing some real momentum in not only governments coming together but also a recognition of the importance of the products that we have to offer and addressing the CBR in threats.

So we are quite excited about that development. We have been working hard with government agencies to push that along and move that along and we see some real benefit over the coming years with that mechanism being in place..

Okay, great..

[Operator Instructions]. Our next question comes from Jessica Fye from JPMorgan. Your line is open. Please go ahead..

Hey, guys this is Ryan on for Jessica. And I guess I wanted to add my congratulations as well for the quick resolution of the manufacturing investigation.

I guess continuing with the discussion on international sales do you sense this to like what the timelines could be and long the review process takes?.

So I think the timeline for sales really depend on every individual government agency that we deliver, they have their own unique processes.

The benefit of having engage with these agencies over the years as we have a pretty good understanding of how they work and what the process requirements might be and how we might be able to interface with key decision makers, ensure that the procurement dollars are there and available.

That’s one of our, I think core competencies really understanding that procurement process particularly in the European and some of the far-east countries. So there is no single answer to that question it does depend on what agencies involve and what countries involved.

Until the drug procurement mechanism that is brand new so we are going to have to get some experience there in understanding exactly how that is going to work.

What’s encouraging for me is that member are in fact talking to each other and have bought to the notion of combining their demands so that they can through a single mechanism procure and get delivers on these medical kind of measures that is really an exciting development from our prospective..

Got it and maybe changing subject just a little bit with the recent approval of IXINITY, could you maybe talk about your thoughts on a commercial strategy for that product?.

Yeah, thanks for the question. I am really thrilled that product across the goal when you might recall it came with the Cangene acquisition all the work had been completed and application was submitted.

The team did respond to the FDA’s request for additional information last year, didn’t cost anything to really get this product across the goal line and I am really please we are now in a position to start address patient requirement.

I am going to ask Barry to talk about more about the specific with respect to the strategy but it is a little milestone and attribute to the teams effort to get us to where we are there.

Barry?.

Thanks, Dan. Yeah, we have got really excited of commercial operations folks and sales people ready to hit the ground running now that we have approval of IXINITY.

No doubt the factor 9 market is a competitive market but we have a product that every bid is good as any of the other standard acting factor 9 products and we intend to differentiate our offering by differentially partnering with the community.

So it not just about the product it is about the product, the people that we have got presenting it and all the programs that are wrapped around it.

One of the specific differences is that Emergent is the only company in the industry that exclusively focused and the Hemophilia B community so those factor 9 deficiency all of the other factor 9 products are in the hands of companies that also have factor 8 product for Hemophilia A which is the vast majority of the market and the part of the market that the Hemophilia B patients feel gets all the attention.

So when you are trying to partner with a community and you have got a meaningful and sincere commitment to the segment of the market that you are serving it tends to resonate much better with the patients. So all of our programs are wrapped around these Hemophilia B patients and the specific segments of the market where our product matches best.

And we have been able to team of sales people who for the most part have been living in the Hemophilia community for many years, if not decades in some cases.

So that’s going to - they come to us bringing their relationships with the providers and the patient advocates in the field and all of that, I think is really going to help us earn our share of competitive market even though we are late entrant with a product that is not all that well differentiated.

It is really not just about the product it is about how we are approaching the market and all the things we got wrapped around it..

Great, thank you so much for taking my questions..

You bet..

Thank you. I am showing no further questions at this time, I would now like to turn the call back to Emergent BioSolutions for any further remarks..

Thank you, - and with that ladies and gentlemen, we now conclude the call. 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. Thanks again and we look forward to speaking to all of you in the future. Good bye..

Ladies and gentlemen thank you for participating in today's conference. This concludes today’s program and you may all disconnect. Everyone have a great day..