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Emergent BioSolutions Inc. (EBS)

Q4 2013 Earnings Call· Thu, Mar 6, 2014

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Emergent BioSolutions Fourth Quarter and Full Year 2013 Financial Results Conference Call. My name is Denise and I'll be the operator for today. At this time, all participants are in listen-only mode. Later we will conduct a question-and-answer session. (Operator Instructions). As a reminder this conference is being recorded for replay purposes. I would now like to turn the conference over to Mr. Robert Burrows, Vice President Investor Relations. Please proceed.

Robert Burrows

Management

Thank you, Denise. Good afternoon everyone. Thank you for joining us today as we discuss our financial results for 2013. As this 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; Adam Havey, Executive Vice President, and President of our BioDefense Division; Barry Labinger, Executive Vice President, and President of our Biosciences Division; and Bob Kramer, Executive Vice President and Chief Financial Officer. Following prepared comments we will conduct a question-and-answer session. Before we begin I am compelled to remind everyone that during today’s call management may make projections and other forward-looking statements related to our business, future events our prospects or future performance. We may also make forward-looking statements during the Q&A session. These forward-looking statements reflect Emergent's current perspective on existing trend 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. These forward-looking statements reflect Emergent's current perspective on existing trends and information. 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. We also refer to certain non-GAAP financial measures that involve adjustments to GAAP reviews. In order to provide greater transparency regarding Emergent’s operating performance please refer to the table which could be found in today’s press release regarding our use of non-GAAP financial measures and the reconciliations between our non-GAAP financial measures and our GAAP financial measures. For the benefit of those who maybe listening to the replay of webcast this call was held and recorded on March 6, 2014, since then Emergent may have made announcements relating topics discussed during today 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 as presented on this call or as presented in the call except as may be required by applicable laws or regulations. Today’s press release may be found on the investors’ homepage of our website at emergentbiosolutions.com. And with that introduction, I would now like to turn the call over to Dan Abdun-Nabi, Emergent BioSolutions' President and CEO. Dan?

Dan Abdun-Nabi

Management

Thanks Bob. Good afternoon everyone and thank you for joining our call today. For my prepared comments I will review the financial results and operational accomplishments for 2013 and discuss the financial forecast and operational goals for 2014. I will then ask Adam Havey to provide an update on the operations of our BioDefense division followed by Barry Labinger who will discuss our Bioscience division operations, Bob Kramer will finish with the discussion of our financial results. To begin; for the full year 2013 total revenues were $313 million which includes product sales of $258 million and GAAP net income was $31 million these results clearly reflect the continued strength of our core business. As you saw from our press release 2013 total revenues grew 11%, product sales were up 19% and GAAP net income increased 32% we are extremely pleased with our 2013 performance which I believe nicely positions us for our future growth. As you might recall on November 2012 we announced the three year growth plan with specific financial and operational goals to be achieved by the end of 2015. As a reminder those goals were to realize product sales and excess of $500 million to have at least three marketed revenue generating products and to achieve a three year net income CAGR that is from 2012 to 2015 in excess of 15%. We are attracting towards the achievement of these goals and our two most recent acquisitions are contributing to that progress. In August of last year, we closed on the acquisition of our RSDL, a personal, chemical decontamination product that is used by the military to protect its personnel. This acquisition expanded our footprint in the biodefense market and leveraged several of our core competencies. RSDL was accretive in 2013 contributing to both revenue and…

Adam Havey

Management

Thank you, Dan. 2013 represented another strong and protective year for the BioDefense division. Key areas of focus for the division included delivering BioThrax doses to the SNS, expanding capacity through Building 55 and integrating RSDL and its associated operations and preparing for the integration of 3 additional BioDefense countermeasures from Cangene; and let me touch on each. First BioThrax, 2013 proved to be another solid year of performance. We distributed approximately 9 million doses or $244 million worth of product to the SNS under our current 5 year $1.25 billion contract with the CDC. We’re currently on track with our commitments under this contract which provides for deliveries through September of 2016. We also secured marketing authorization for BioThrax in Germany, a key step in our plan to expand the customer base for BioThrax. Following this approval, we initiated the mutual recognition process within EU for standard international registrations of BioThrax. In 2014, we expect to continue to meet our delivery commitments to the CDC, further expand our reach internationally by continuing the mutual recognition licensure process in Europe and completing the license submission to the FDA for our post exposure prophylaxis or PEP indication. The PEP label expansion directly addresses the requirements of the U.S. government. And more importantly enhancements to BioThrax further submitted as drug gold standard for protection against anthrax disease. Second, progress on the capacity expansion for BioThrax in Building 55. In the last few months, we made significant progress with the FDA on the process in protein profile comparability requirements. The next step is to initiate the manufacture of our consistency lots which will occur in the near future. Following the completion of these lots, we will initiate the pivotal non-clinical studies during the second half of this year. We remain on track to…

Barry Labinger

Management

Thanks Adam. 2013 was the beginning of our transition towards building a BioSciences Division in our growing profitable specialty biopharmaceutical business. We focused our investments on the most advanced and promising assets, made progress with those assets towards value inflection points and with the Cangene acquisition added a strategically important revenue base and significant new capabilities. Let’s start with otlertuzumab. In 2013, we substantially completed the treatment phases into important combination studies in CLL. Preliminary results for these two studies were reported at ASH in December. The first study is a randomized trial comparing otlertuzumab plus bendamustine versus bendamustine alone in relapse refractory CLL. In this study, the addition of otlertuzumab to bendamustine more than doubled the IWCLL overall response rate from 32% to 69%. Likewise complete responses increased from 3% to 14%. This represents clear demonstration of clinical proof-of-concept for otlertuzumab. The study is still ongoing as patients will be followed for 18 months to evaluate duration of response, progression-free survival and overall survival. At ASH preliminary data were presented showing the suggestion for improved overall survival although data were fairly immature. In the coming months maturing data will become available to provide new information regarding overall survival and importantly progression-free survival, which would be the primary endpoint in any Phase 3 trial. The second study combined otlertuzumab with Rituximab in a single-arm trial in frontline CLL patients. And the data reported at ASH suggest that otlertuzumab and Rituximab could service two components of reflective treatment regiments for CLL. In both studies, otlertuzumab did not appear to add clinically significant toxicity to either Bendamustine all Rituximab, which is an important finding supporting the potential for otlertuzumab in various combinations. So where do we go from here? We believe that the data generated with otlertuzumab last year support advancement to…

Bob Kramer

Management

Thank you, Barry and good afternoon everyone. I’d first like to make some general comments about our consolidated performance for 2013 compared to prior year and then turn to some highlights of our two operating divisions and then finish up with some details related to our 2014 forecast. For 2013 total revenue was $313 million up 11% from prior year of $282 million due to higher BioThrax sales and the addition of the RSDL sales. Our gross profit on product sales was $196 million which translates into a gross margin of 76% continuing our historical trend of between 70% and 80%. At the operating income line, we generated a profit of $43 million or 14% of total revenue this exceeded the prior year by $13 million due in part to the $9.6 million charge we recorded in 2012 related to the write down of our SBI-087 asset. Gross research and development expense was slightly lower year-over-year due mainly to reduced BioDefense development spending. SG&A was higher year-over-year by $12 million due to a combination of items including $2.8 million in costs related to restructuring of our UK operations, $3.8 million in transaction related costs associated with the acquisitions of HPPD and Cangene and $1.6 million of covered well to RSDL sales. Excluding these costs SG&A in 2013 increased by $3.7 million or 5%. GAAP net income was $31.1 million squirreling the middle of the range we communicated in early January and higher than the 2012 net income of $23.5 million by nearly $8 million or 32% higher. Non GAAP net income for 2013 came in at $36.2 million compared to $30.2 million for 2012. A table reconciling GAAP to non-GAAP net income is included in our press release today. Going forward, we will continue to report non-GAAP net income in…

Operator

Operator

(Operator Instructions). Our first question comes from Cory Kasimov with JPMorgan. Please proceed.

Cory Kasimov - JPMorgan

Analyst

Hey good afternoon guys, thank you for taking the questions. My first one is on BioThrax in your OUS strategy. I guess I’m wondering that with multiple approvals outside of the U.S. and mutual recognition process underway, when might you decide to start selling in a meaningful ways to those countries. Are you waiting to see if the U.S. government buys all 25 million annual doses you expect to manufacture building 55 to determine if it makes sense to build up the second train there or would you consider using your existing pilot facility to generate some excess supply if necessary, I’m just wondering kind of what the plans are there, it just seems like it’s a pretty meaningful opportunity?

Dan Abdun-Nabi

Management

Yes, thanks for joining the call today, really appreciate and appreciate the question. So international markets clearly an upside opportunity for us. As you know all these years we’ve been capacity constraint and so your question is getting more and more time and as we progress towards building 55 license. I will ask to Adam to talk about some of our thinking around international markets, because we are as I said moving towards approval of 55, this clearly an entry staff there and we are developing our international sales strategy. So [if affect us] it’s something that’s a work in progress. But Adam maybe you could add some color.

Adam Havey

Management

Sure. Thanks Cory. I think two points to make on top what Dan mentioned, obviously we're landing the ground work with these approvals and the mutual recognition process to enable that market, but as you know right now all of our capacity is really, all practical capacity is sold to the U.S. government. So from a timing perspective I think it will see international sales begin to be more meaningful I think once 55 is approved. And as you mentioned if demand in ex-U.S. or outside U.S. government exceeds the 25 million doses, we’ve got the ability to ramp up that facility with an additional training. So I think in the next year and a half, we are going to see the, with an additional train. So I think in the next year an a half, we are going to solidify the approvals in those other countries and with that, in parallel with that solidify the sales and marketing strategy and approach. I think one other thing to mention on top of that is with both the Cangene acquisition and adding that commercial infrastructure on the Biosciences side as well as the RSDL acquisitions, we are able to gain a strong international sales team and channel because RSDL has already sold them to over 30 countries. So when combining that capability with our regulatory strategy and we hope that will pay off in the future.

Cory Kasimov - JPMorgan

Analyst

Okay.

Dan Abdun-Nabi

Management

And I think, the other thing I would add there is the use of building 12 is it is a very valuable production facility with FDA license. We are complying organization and operation there. So we will need to figure out what the best utilization is going to be keeping in mind that the U.S. government, we have to talk to them about that, there could be a need for pack up redundancy there and the question is how do they want to see that being utilized. So I think there is some discussions that we need to have with the government before making some final decisions about the migration from building 12 and what its future use might be. And lastly with respect to your specific comment about building out a second train, I think it’s pretty clear that the U.S. government takes the entire capacity of the first train then there is a financial rationale for installing the second train in order to address what might be going worldwide market.

Cory Kasimov - JPMorgan

Analyst

Okay, that is helpful. And then a couple of housekeeping questions regarding the Cangene acquisition. I saw yesterday afternoon BioDale announced full finished agreement with you. How material are these types of deals for you and should we expect more agreements like this in the future? And then are you able to use any of Cangene’s net operating losses going forward to lower your tax rate?

Dan Abdun-Nabi

Management

So on the first, I will ask Barry, as you know, the CMO operation is part of the BioSciences division, we were very excited about that core competency coming into the division and the revenue that it brings and the growth potential that it brings. And then I think on the NOLs, I’ll ask Bob to pick that one up. But Barry may be you can talk about that particular contract and what that might mean.

Barry Labinger

Management

Sure. Yes Cory, we’re very happy to see the Biodel deal announced yesterday. That’s been a deal that our Cangene colleagues have been working on for quite some time. That’s one of the many customers that will have in that plant generating revenue. That particular deal has a nice long-term flavor to it. So, it’s very reliable in and of itself it’s one piece of a much larger pie. So there is a very nice stable growing revenue stream in that Baltimore facility from contract manufacturing for Fill & Finish.

Bob Kramer

Management

So, Cory on the net operating losses for Cangene, I guess first of all, a lot of those are kind of captured in Canada and we’re looking at our, at amending some tax structures and strategies to make our structure a bit more efficient. It’s going to take some time. I wouldn’t expect us to be able to utilize those NOLs anytime in the next year or so but we obviously are looking at putting in place a more efficient tax structure.

Cory Kasimov - JPMorgan

Analyst

Okay. That’s helpful. Thanks for taking the questions.

Bob Kramer

Management

Sure. Thank you.

Operator

Operator

Our next question comes from Eric Schmidt with Cowen & Company. Please proceed. Eric Schmidt - Cowen & Company: Thanks for taking my questions. First, just Bob on the move toward non-GAAP financial accounting, can you provide guidance for 2014 as to what are the numbers, what kind of magnitude of additional non-GAAP removed expenses we’ll see?

Bob Kramer

Management

Yes sure, thanks for the question and for joining. Yes, I think we are going to be in a position Eric to do that later this year. We’re sticking with the 30 million to 40 million in GAAP net income guidance for right now. Clearly as we experienced in 2013, we’re going to have some transaction cost related to acquisition activities that we know about today and potentially future ones that we will be making adjustments for on a non-GAAP basis. And when those are incurred, we will be providing that detail to you when we report actual results going forward. Eric Schmidt - Cowen & Company: Okay. I mean I think I have kind of cited you on the conservatism of the 2015 EPS targets before the 15% annual growth; it only kind of gets you to about $1 per share in earnings in 2015 and you are tracking on a GAAP basis despite all these merger related expenses to do around that level this year. When is the good time to update that guidance?

Dan Abdun-Nabi

Management

Yes, I mean I’ll take that one Eric. So as you know when we put out the three year plan, the grounding for that trajectory was really built around our historic growth, both on revenue and net income over the last 10 years or so. So, we are now working on an updated plan going beyond that ‘15 period. So I think as we develop that plan and we identify what we believe are reasonable targets for the organization going forward, we’ll be in a position to update it. But I wouldn’t expect anything this year. Eric Schmidt - Cowen & Company: Okay. One last one, just on the progress report you gave in terms of Building 55 and a comparability profile discussions you’ve had with the FDA, what can you tell us sort of maybe more granular that might increase our confidence that you are going to hit the specs in these consistency lots and be on track to file in 2015?

Adam Havey

Management

Sure Eric, this is Adam. I’ll just jump right in. So as I mentioned in my comments, we’ve done a lot of work with the FDA really in the fourth quarter and actually had a formal meeting with them in December where we talked about those comparability and protein profile requirements. And as a result of that discussion, they asked us to submit a data package in January, which we did and we're really waiting to hear back from them, we should hear back from them very soon. And as soon as we do hear that we’ll go into those consistency lot manufacturers into that step of manufacturing those consistency lots. So we have a lot of confidence in the data package. The dialogue was very collaborative and we’ve got some great feedback. And we're excited about taking the next step. So you will be hearing more about that soon. Eric Schmidt - Cowen & Company: So Adam it’s something that…

Dan Abdun-Nabi

Management

I’d add some color to that a little bit, the data package [enjoyed] the profile that we’ve presented to the FDA is based on significant number of runs being conducted in the facilities. So this is on the basis of a couple of runs and we're throwing a dart at the dartboard. This is really based on well understood process, DOE circle back several years, so we understand the entire design space. And the process is very manageable so that we, as we migrate various inputs, we understand exactly what the outputs might look like. So from our standpoint, we could be may be adding and provide color on the exact number of runs, but it’s many, many runs that had enabled us to really come up with some specifications that we believe are reproducible and achievable and that’s the bases on which we presented that package to the FDA. Adam do you have any thoughts in terms of….

Adam Havey

Management

Eric, let me just add some details. We have done more than 60 full scale runs over the years and that’s been part of our ongoing development contract with BARDA. And as I stated earlier, I think we are really confident in what the process is, we are just refining some of those protein profile characteristics. Eric Schmidt - Cowen & Company: Great. Thanks for the update and congrats on the progress.

Dan Abdun-Nabi

Management

Thanks for your support, really appreciate it.

Operator

Operator

(Operator Instructions). We have no further questions. I would now like to turn the call back over to management for closing remarks. Please proceed.

Robert Burrows

Management

Thanks you, Denise. Ladies and gentlemen, that's all the time we have today. And thank you for your participation. Please note that today's call has been recorded and a replay will be available beginning later today. Alternatively there is available a webcast for today's call, an archived version of 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

This concludes today’s conference. You may now disconnect. Have a great day.