Emergent BioSolutions, Inc. (NYSE:EBS)
Q4 2013 Results Earnings Conference Call
March 06, 2014 05:00 PM ET
Robert Burrows - VP Investor Relations
Dan Abdun-Nabi - President and CEO
Adam Havey - EVP and President of BioDefense Division
Barry Labinger- EVP and President of Biosciences Division
Bob Kramer - EVP and Chief Financial Officer
Cory Kasimov - JPMorgan
Eric Schmidt - Cowen & Company
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.
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?
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 net income. In December we announced the proposed acquisition of Cangene Corporation which we closed just two weeks ago.
With this acquisition, we now have a combined portfolio of five biodefense products addressing a broad array of biological and chemical threats want to better meet the needs of our government customers. Additionally we now offer four marketed hospital based specialty therapeutic products that address infectious disease, hematology and transplantation.
Moreover the acquisition expanded our core manufacturing capabilities with a revenue generating contract manufacturing organization with finished capabilities. We look to complete the integration in 2014 and we anticipate that the Cangene operation will significantly contribute to our revenues and will be accretive.
The 2014 we are reaffirming our full year total revenue forecast of $415 million to $445 million with net income of between $30 million to $40 million. For the first quarter of 2014, we anticipate total revenues of between $45 million to $55 million. Our 2014 operational goals include completing the integrating of Cangene, completing Building 55 comparability and non-clinical work to enable submission of our sBLA in the first half of 2015, securing a partner for otlertuzumab and other products based on our adopt ADAPTIR platform technology, and completing additional strategic acquisitions that levers our core competencies and align with our growth plan.
Finally, I would like to take moments to note that 2013 marked the 15th anniversary of the company’s founding. When Emergent began in 1998, we started with the single site producing a single product for a single customer. Over the subsequent 15 years, we have built Emergent into a multi-national company focused on biodefense and commercial markets.
We now have a portfolio of 9 revenue generating products supported by significant manufacturing infrastructure, as well as domestic and international sales and marketing operations. The product development expertise, we have gained through multiple value enhancing acquisition drives our pipeline for future products and platform technologies.
These significant achievements are the results of the dedication and hard work of our employees, our management team and our board of directors. It is because of their efforts and the commitment of our customers, partners, and stockholders that we are positioned to continue this history of great growth going forward.
In summary, 2013 was a year in which we significantly advanced the company, and we look forward to continuing to build on that momentum in 2014. That concludes my prepared comments and I will now turn it over to Adam Havey, who will provide an update on BioDefense division. Adam?
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 file the sBLA submission for Building 55 in the first half of 2015.
Third, RSDL: We completed on schedule and on budget the integration of RSDL and its associated operations which resulted in RSDL contributing over $11 million of product sales in 2013, despite only being in our hands for five months. And this performance exceeded our sales forecast.
In 2014, we will be focused on growing RSDL sales through continued deliveries under the existing DoD IDIQ contract as well as ongoing sales to Foreign Ministries of Defense made of global first responders. In addition we will be pursuing targeted product expansions including the decontamination or removal of toxic and industrial chemicals and pesticides.
Lastly, the addition of the three BioDefense counter measures resulting from Cangene acquisition, AIG, BAT and VIG are all procured under a long-term contract with U.S. government for inclusion in the SNS. In Cangene’s fiscal 2013, these three products generated approximately $50 million in revenue. In 2014 we look to drive incremental growth in sales of these products as we begin to leverage our combined capabilities. We look to deliver under existing domestic contracts while at the same time beginning to drive incremental foreign sales where these products currently have a limited international footprint.
And looking at the BioDefense division as a whole, we now offer a suite of 5 medical counter measure including vaccine, therapeutics, and devices addressing multiple CDR anthrax serving needs of governments and others worldwide. And in 2014, we will be focused on growing our customer base through leveraging our expanded product offering and commercial capabilities. For example, we will explore using alternative selling strategies including portfolio sales and cross-selling, which we believe can be successful in this marketplace.
Finally, in building on this concept of a BioDefense suite of products, in 2014 we will be focused on expanding and further diversifying our footprint across the CBRN landscape through selective acquisitions. Our targets will continue to be revenue generating products with appeal to U.S. and foreign governments, products that have potential dual use across both government and commercial settings and product candidates that have existing USG development funding.
In summary, 2013 was a significant year of execution and expansion for the division and 2014 promises to be the year that we will build on that expansion. That concludes my prepared comments. And I’ll now turn it over to Barry, who will provide an update on the BioSciences Division. Barry?
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 Phase 3. However as we have announced previously, we do not plan to initiate Phase 2 trials until we secure partnership. We have been in active discussions with potential partners, there continues to be interest in the program and clear agreement that we have a novel agent that is active and well tolerated.
The challenge is that the competitive landscape is becoming increasingly crowded with the recent and upcoming approvals of several new drugs in CLL, particularly ibrutinib, idelalisib and otlertuzumab.
These agents represent a major step forward in CLL treatment which is greatness for patients. However, they complicate our ability to find a common vision with potential partners regarding the role of otlertuzumab in these evolving markets.
We believe that there will continue to be unmet need in CLL. The new oral kinase inhibitors offer high response rates, but very few complete responses and most patients will likely require chronic treatment to maintain responses.
Chronic treatment has significant cost implications, as well as the potential for toxicity and resistance. So combination therapies that are well tolerated and offer the possibility of sustained readmissions of treatment will be in demand.
Otlertuzumab is well positioned to be a part of such regiments. So we continue to engage in discussions with potential partners with the intent to advance the Phase 3 once we reach agreement.
In the meantime, we’ll continue to generate important new data from ongoing studies, but we’ve significantly reduced expenditures on this program in advance of the partnership. We’re also making good progress in validating the bi-specific ADAPTIR platform. Our current focus is on redirected T-cell cytotoxicity using a novel anti-CD 3 approach to mobilize T-cell mediated immunity against validated tumor targets. ES414 is our first example of this targeting CD3 and PSMA, which is widely expressed in prostate cancer.
There have been other similar RTCC approaches in the clinic which provides some clinical validation. We believe our technology offers significant differentiation based upon potency, dosing convenience and most importantly, safety.
Many of these improvements are likely to declare themselves early in development specifically Phase 1 which will help generate early interest from potential partners. Based upon positive preclinical data and a successful pre-IMD meeting with FDA, we are on track to initiate a Phase 1 trial with ES414 later in 2014.
For the Biosciences division, the acquisition of Cangene is transformative. The biosciences’ component of Cangene revenues which were $77 million during their last fiscal year will help progress the division towards profitability.
In addition we have added significant new capabilities. The specialty commercial infrastructure that’s in place to support products like WinRho, episil and HepaGam B provide an opportunity to add additional products with less incremental commercial cost.
The fill/finish facility in Baltimore provides growing revenue, as well as the opportunity to move our own products from contract manufacturers to our own facilities. So this transaction provides an important revenue base now and it enables further revenue growth in the future.
Since the announcement of the deal, our focus has largely been on planning for the integration, which is in implementation mode as we speak. The culture and values of the two companies have a lot in common and the leadership and employee base is very talented. So far the integration is going smoothly.
Having close with deal, we're now able to dive deeper into the marketing plans for the commercial products. These products are quite mature so we expect the revenue to be relatively stable. However we're optimistic that we will be able to generate some incremental growth through pricing and other commercialization strategies for certain products. We’ll be able to provide more color on these plans in the coming months.
Additionally, we are now able to focus on a review and prioritization of the development portfolio for the combined company. We intent to evaluate these programs with an eye towards generating revenue growth as soon as possible, while optimizing our net R&D spending, again more to come on the outcomes of this process.
In summary, 2013 was the start of our strategy to transform a BioSciences Division from a pure R&D organization to a fully integrated and profitable biopharmaceutical business targeting medical needs in specialty markets. With the acquisition of Cangene, we’ve added a stable revenue base, as well as capabilities and opportunities to drive revenue growth in the near-term.
We remain excited about a number of our development program and we continue to advance them towards value inflection point. Simultaneously, we are carefully managing our R&D spending and working towards partnership. We look forward to continued progress in 2014.
I’ll now turn it over to Bob who will take you through our financials in more detail. Bob?
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 addition to GAAP net income in order to more appropriately reflect the financial performance of our core business.
Note that for 2013, our effective tax rate was at 30% which reflects the impact of tax credits associated with research and development activities incurred throughout the year.
At yearend our balance sheet continued to reflect a very strong capital position. On the asset side, our combined cash and accounts receivables totaled $240 million essentially flat with the level in 2012. On the liability side, we entered into a senior secured credit agreement in December of 2013, which included a $100 million revolving credit facility with the syndicated banks. In connection with this agreement we borrowed $62 million to repay existing debt obligations.
In January of this year we completed a $250 million convertible debt offering the proceeds of which we used to finance the Cangene acquisition and repaid the $62 million debt obligation.
At the division level, the BioDefense unit had another solid year performance led by BioThrax sales of $247 million, an increase of $31 million over 2012. In 2013 we also delivered approximately 9 million doses of BioThrax. 2013 product sales for BioDefense also included $11 million in RSDL sales. In addition, the BioDefense division recognized approximately $54 million in grants in contract revenue.
For the Biosciences division in 2013 we included the investment of over $51 million in research and development up $6 million from 2012 primarily driven by an increase in investment in the clinical development of otlertuzumab partially offset by reduced spending in the TD program which we discontinued in early 2013.
We are reaffirming our 2014 forecast for total revenues of between $415 million and $445 million which represents year-over-year growth of between 33% and 42%. We are also reaffirming our guidance for 2014 net income of between $30 million and $40 million on a GAAP basis. Importantly included in the GAAP net income forecast for 2014 are certain non-recurring, non-core costs including transaction and integration cost related to the Cangene acquisition.
For the first quarter of 2014 we’re forecasting total revenues of between $45 million and $55 million. The strong financial performance we experienced in 2013 combined with our expectations for 2014 have some good shape to achieve the year end 2015 financial and operational goals outlined in the growth plan and commented upon by Dan earlier.
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.
(Operator Instructions). Our first question comes from Cory Kasimov with JPMorgan. Please proceed.
Cory Kasimov - JPMorgan
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?
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.
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
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
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?
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.
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.
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
Okay. That’s helpful. Thanks for taking the questions.
Sure. Thank you.
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?
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?
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?
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…
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….
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.
Thanks for your support, really appreciate it.
(Operator Instructions). We have no further questions. I would now like to turn the call back over to management for closing remarks. Please proceed.
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.
This concludes today’s conference. You may now disconnect. Have a great day.