Earnings Call Transcript - EBS Q3 2014

Operator, Operator

Good day, ladies and gentlemen, and welcome to the Third Quarter 2014 Emergent BioSolutions Incorporated Earnings 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. As a reminder, this conference is being recorded for replay purposes. I would now turn the conference over to the company. Please proceed.

Robert Burrows, VP, Investor Relations

Thank you, Denise. 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 third quarter and nine months of 2014. As is customary, our call today is open to all participants. And in addition, the call is being recorded and is copyrighted by Emergent BioSolutions. 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. For the call today, Dan will discuss the state of our business including high-level current period financial results and an overview of divisional operations; Adam will discuss in greater detail, the current state of the Biodefense operations; Barry will discuss in greater detail the current state of the Biosciences operations; and Bob will conclude with a detailed discussion of our financial performance and outlook. Following the prepared comments, we will conduct a Q&A session. Before we begin I am compelled to 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, and 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. 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. During our prepared comments or 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 two tables, one for the third quarter and the other for the nine-month period found in today’s press release, regarding our use of non-GAAP or adjusted financial measures and the reconciliation between our non-GAAP adjusted 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 November 06, 2014, 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?

Dan Abdun-Nabi, President and CEO

Thank you, Bob. Good afternoon everyone and thank you for joining our call. Over the course of 2014, we have made significant progress in our priorities to grow our business consistent with our growth plan. Our revenue and net income performance was strong with third quarter revenue of $138 million. This is above the guidance of between $110 million to $125 million that we provided during our earnings call in August. For the quarter, our GAAP net income was approximately $22 million and our non-GAAP adjusted net income was $25 million. Historically, our fourth quarter is our strongest quarter both in terms of revenue generation and net income performance. We anticipate this trend will continue this year based on expected financial contributions from our BioThrax business, additional product sales in both divisions, contract manufacturing operations, and our contracts and collaborations business. As announced in today's press release, given our strong financial performance today and our anticipated progress for the remainder of the year, we are increasing our full year 2014 revenue guidance to between $440 million to $460 million and GAAP net income guidance to between $35 million to $45 million. We're also increasing our adjusted net income guidance to between $50 million to $60 million. Operationally, we continue to make progress in our priorities across both divisions. For our Biodefense division, our core business continues to be strong and we remain on plan for the expansion of BioThrax manufacturing and Building 55. Moreover, with a broader portfolio of Biodefense products, we are making steady progress on expanding sales including our international markets with additional growth anticipated in the fourth quarter. We have advanced our cost containment objectives through a consolidation of sales and marketing operations and the realignment of sectors of our workforce to create additional operational efficiencies and better leverage our resources. Adam will provide greater insights into the division operations during his prepared remarks. We’re also seeing solid progress in our Biosciences division. The Cangene integration continues to progress well and in that process, we have identified synergies that can streamline our business operations to reduce costs including R&D spending. To that end, we are closing and selling select R&D facilities, consolidating certain operations, and discontinuing programs that are not consistent with our growth plans. Barry will discuss this in greater detail during his prepared remarks. Of note, we recently completed a significant collaboration agreement with MorphoSys that provides for joint worldwide development and commercialization of ES414, our immunotherapeutic protein targeting prostate cancer. Under the terms of the agreement, which provides for payments of up to $183 million, we received $20 million in an upfront fee with future payments based on traditional product development milestones. This is an exciting collaboration of a product candidate developed on our ADAPTIR platform. And just as an example of how we can expand our product portfolio with potentially valuable candidates while effectively controlling overall R&D spending. With respect to M&A, we continue to make progress on targets that will leverage our core competencies and drive further progress towards achieving growth in our business. For our Biodefense business, we’re focused on medical countermeasures that governments currently stockpile whereas international demand will address CBRN detection and diagnostic opportunities or carry with them contract and grant funding. For our Biosciences business, we continue to seek revenue-generating opportunities to enhance both top-line and bottom-line performance that are aligned with our current clinical focus areas. Further, our Biosciences team is pursuing partnerships for products developed on our ADAPTIR platform as well as for the platform itself. In closing, I’d like to comment on our progress towards achieving our 2015 growth plan targets. As you might recall, in 2012, we set financial and operational targets to be achieved by the organization by the end of next year. Specifically, we targeted greater than $500 million in product and service revenue from at least three marketed products that would provide a 2012 to 2015 net income CAGR of greater than 15%. At this point, we are on or ahead of schedule to achieve these goals. As we move towards 2015, we are planning the next phase of our corporate growth. Currently, we’re working with our Board of Directors to finalize our next multiyear strategic plan which I expect to be able to share with you by the middle of next year. That concludes my prepared comments and I now turn it over to Adam Havey who will discuss the Biodefense Division’s operations in greater detail. Adam?

Adam Havey, EVP and President, Biodefense Division

Thank you Dan. During the third quarter, we continued to make solid progress expanding our Biodefense business by focusing on what we do best: delivering CBRN countermeasures that address current health threats, advancing the development of additional medical countermeasures and platforms that address unmet public health needs, and building a flexible, vertically integrated manufacturing infrastructure capable of rapidly producing vaccines, therapeutics, small molecules, and other biologics, and expanding the use of our product portfolio on a global basis. So let me highlight our recent accomplishments. In the third quarter, Biodefense revenues were just over $104 million, greatly contributing to the overall performance of the company year-to-date as well as to the increased outlook for full year 2014. The third quarter revenue included $66 million in BioThrax sales and over $26 million in contract and grant revenue. BioThrax revenue was primarily from sales under our current five-year $1.25 billion contract with the CDC to deliver 44.75 million doses to the strategic national stockpile. Delivery of BioThrax this quarter was on track and comparable to deliveries this time last year. Other Biodefense revenues totaled $21.4 million so far this year. RSDL sales for the three-month and nine-month periods were in line with our expectations, including first-time purchase orders for a number of strategically important countries. As with that, we completed a substantial delivery of product to the SNS under our multi-year USG contract. And lastly, AIG revenue was attributable to deliveries under our current USG contract and we are working diligently to respond to FDA requests during the BLA review. We are optimistic that this product will be licensed in early 2015, which will trigger a $7 million payment. Next, let me update you on Building 55, our large-scale BioThrax manufacturing facility. Back in September, we announced initiation of the pivotal non-clinical study designed to show that BioThrax manufactured in Building 55 is comparable to that manufactured in our current approved facility. I’m pleased to report that this study is progressing according to plan and the in-live phase should be completed in Q1 2015. We are targeting a rolling sBLA solution to the FDA, the first part which is planned to be submitted in early 2015. The key steps that need to be completed in order for this facility to be licensed include successful completion of an FDA inspection of the facility, completion of the non-clinical study, and the analysis of the data from that study and of course FDA approval of the entire package including data from the completed comparability protocols. While there is much to do, our target continues to be to complete all of these activities in 2015. The schedule is tight and it is possible that we will see the approval in early 2016. On our contract and grants side, we received two new contracts during the third quarter. First, the CDC exercised the contract option valued at $18.9 million for VIG, our therapeutic license for the treatment of complications due to smallpox vaccination. This three-year option supports ongoing stability of the product as well as collection of plasma. Second, in September we were awarded another contract valued at up to $29 million for the development of the dry formulation of NuThrax, our next-generation anthrax vaccine that adds CPG 7909 adjuvant to BioThrax. Dry formulations of NuThrax should enable storage at ambient and higher temperatures, thus eliminating the cold chain during shipping and storage. Switching gears to a topic that has been in the media recently, I would like to briefly touch on Emergent's efforts to respond to public health emergencies. As you know, Ebola has been a tremendous concern mostly in West Africa but also here in the U.S. As our federal government works to respond to this crisis, we have issued task order requests for the production of developmental therapeutic candidates. In 2002, the government put infrastructure in place to quickly address Emergent BioThrax when it created with industry, Centers for Innovation in Advanced Development and Manufacturing. Our facility in Baltimore, Maryland is one of those three designated centers. We will submit our proposal to BARDA next week and anticipate they may make one or more awards shortly thereafter. At this point, we cannot predict the timing or the amount of any potential awards. We also anticipate that BARDA will likely issue additional past quarter requests related to Ebola in the coming months. Given our track record of partnering with the U.S. government, we are prepared to assist the government in their response to the significant global health crisis. That concludes my prepared comments. And I will now turn it over to Barry who will provide an update on the Biosciences division.

Barry Labinger, EVP and President, Biosciences Division

Thanks, Adam and good afternoon everyone. During the third quarter we made good progress toward our goal of building a high-growth biopharmaceutical business that meaningfully enhances patients’ lives and is financially self-sufficient. Having completed a thoughtful portfolio assessment following the close of our Cangene acquisition, we've made some decisions and implemented them to restructure the business for its greater financial health. Let me focus on a few examples. We're very excited about our participation in the attractive immune-oncology space specifically our proprietary redirected T-cell cytotoxicity or RTCC approach with our ADAPTIR platform. These are bispecific therapeutic proteins that bind the antigen zone on tumor cells such as PSMA prostate cancer cells and through CD3, which is expressed on T-lymphocytes. The anti-CD3 part of the molecule activates a T-cell mediated immune response targeted against the tumor cell. Other companies are also pursuing RTCC as it’s a very promising approach. Our technology offers some clear benefits. In preclinical studies, we see protein activation of T-cell activity with less release of cytokine. As you’re probably aware, the release of cytokines at high levels can lead to safety issues. Our molecules also offer pharmacokinetic advantages such as long half-life leading to less frequent dosing, as well as manufacturability advantages. Our most advanced RTCC program is ES414 or Anti-PSMA Anti-CD3 Molecule, which is poised to start Phase I in the next couple of months in patients with prostate cancer. Consistent with our overall strategy of securing partnerships for early-stage programs, we’re pleased to have signed a co-development and commercialization agreement with MorphoSys, a successful German-based biotechnology company known for its scientific excellence and which is building an exciting development stage pipeline largely in oncology. In the third quarter, we recognized a little over $15 million of revenue on the $20 million upfront payment. We’re also having a milestone payment upon dosing of the first patient in the Phase I study, which is planned for late this year and is included in the financial outlook we’re putting forward today. We’ll be working in close collaboration with MorphoSys throughout the development of ES414. And when we take into account the upfront and milestone payments and MorphoSys’ responsibility for 64% of the development cost, our net investment in the development of ES414 will be small for a number of years to come. Once licensed, Emergent will commercialize ES414 in the U.S. and Canada and MorphoSys will commercialize in the rest of the world. We look forward to clinical data for this program over the next couple of years and we’re also working towards additional partnerships around other product candidates from our RTCC platform. One of the programs in the Cangene portfolio was a recombinant human growth hormone product. We decided to discontinue investment in this program and eliminated essentially all spending on it earlier in the year. We’re also seeking to exit the smaller of our two Winnipeg manufacturing facilities on our Annual Day. If successful, the sale of this facility will help reduce our overhead costs moving forward. We have previously reported our intention to hold off on Phase III development of otlertuzumab for CLL unless and until we secure our partnership. As a consequence, spending on otlertuzumab has been dramatically reduced from approximately $27 million in 2013 to a 2014 expectation of less than $10 million and much less than that in 2015 based on limiting the programs to generate data from a low-cost triple combination study that could be valuable in our partnering efforts. We also announced during Q3, the closure of our Munich R&D site, which has been dedicated to the development of our proprietary viral vaccine vector technology known as MVA. While promising, the product candidates emerging from this platform are quite early stage and we’ve determined that it’s not consistent with our strategy to maintain investments in these programs. The site will be substantially closed by the end of this year with modest shutdown activities extending into the first half of 2015. As these examples illustrate, we continue to build financial strength in our Biosciences business. We’re working towards financial sales efficiency for this business while simultaneously assembling a portfolio of assets that will drive sustained revenue growth. We have an active business development effort targeting both partnerships for our existing products and technologies as well as acquisitions of new products that will provide near-term revenue growth. With that, I'll turn the call over to Bob Kramer. Bob?

Bob Kramer, EVP and Chief Financial Officer

Thank you, Barry and good afternoon to everyone on the call. I’m going to discuss our financial performance for the third quarter and then turn to a summary of where we are on a year-to-date basis as we head into the fourth quarter, targeting to deliver the increased revenue and net income performance mentioned earlier on the call. Before I jump into the details of the third quarter, I’d like to highlight a few comments made on our Q2 earnings call in August as a backdrop to our Q3 results. On that call, we discussed our expectation of increasingly strong financial performance in the second half of 2014 in order to meet our projections. We forecasted our Q3 revenues to be between $110 million and $125 million which reflected this improved performance. We also guided that our sales mix would generate improved operating margins in the second half of the year as higher-margin BioThrax sales became a greater percentage of our overall product revenue. And lastly, we discussed our continued focus on advancing our ADAPTIR platform product candidates through partnerships as a way of demonstrating the value of our technology and importantly deferring R&D costs. During the third quarter, we made significant progress on all fronts, starting with total revenue which was around $138 million, outperforming the midpoint of our range by $20 million and bettering our Q2 total by $25%. This performance was a result of the combination of the continued strength of our Biodefense business and boosted by the Bioscience business in the recognition of approximately $15 million of the $20 million upfront fee associated with the partnership with MorphoSys focused on ES414, our ADAPTIR prostate cancer product candidate. Drilling down a bit, total product sales for the quarter came in at $85 million. Of that, $77 million was generated from our Biodefense division led by BioThrax, a $66 million contribution in the quarter. The other Biodefense products contributed $11 million in sales for the quarter. The Bioscience products contributed an additional $7 million to revenue, all of which was incremental to last year due to the timing of the Cangene acquisition earlier this year. In addition to the $85 million of product revenue, we generated contracts, grants, and collaboration revenue of $44 million along with CMO revenue of $9 million. The contracts, grants, and collaboration revenue reflects the impact of the recognition of the MorphoSys upfront payment. As a result of the improved sales mix, our consolidated gross margin for the quarter was 65%, up from the prior quarter of 61%. As mentioned on the last call, the new norm for our consolidated gross margin is between 60% and 70%. So with our Q3 results, we're right in the middle of this new range. Walking further down the income statement, gross R&D expense for the quarter was $44 million or $15 million above last year's quarter, primarily due to development programs acquired from Cangene. Adjusting for the contracts, grants, and collaboration revenue line, which reflects reimbursement for development costs, our net R&D spending for the quarter was de minimis at approximately $1,000. SG&A expense for the quarter was $30 million, $8 million above prior year quarter, again largely due to the additional cost associated with the Cangene acquisition. Importantly, however, our SG&A for each of the three quarters of 2014 has remained at a relatively constant level of around $30 million. We will continue to pursue further optimization in this line item as we grow the business. The favorable revenue and margin performance during the quarter were key contributors to generating $22 million in GAAP net income or $0.58 per basic share; this compares to prior year GAAP net income of $13 million or $0.37 per share. On a non-GAAP basis, adjusted net income was $25 million or $0.67 per share compared with $16 million or $0.43 per share for the comparable period in 2013. Turning to the year-to-date performance, the nine-month financials reflect the continued fundamental strength of the Biodefense business aided by the company’s efforts to manage net R&D costs and our continued focus on sharing development risk by securing opportunities to partner with third-parties on R&D projects, particularly for our ADAPTIR platform candidates. For the nine-month period of 2014, our GAAP net income of $7 million includes $13 million of adjustments or acquisition-related costs and other non-recurring and non-cash expenses. After adjustments, the year-to-date adjusted net income was $20 million. Although this is essentially even for the adjusted net income for the same period in 2013, it does represent accelerated net income performance compared to the prior year period. In addition, to the strengthening financial performance reflected in our income statement, our balance sheet continues to improve. At quarter-end, our cash position was $242 million with another $44 million of receivables. As a result of the financial performance in Q3, we’ve put ourselves in a good position to deliver increasingly strong financial results in Q4. Accordingly, we’ve increased our outlook for 2014 across all three metrics. Specifically, we’ve increased our revenue guidance to between $440 million and $460 million. We’ve increased our GAAP net income guidance to between $35 million and $45 million. And we’ve increased our adjusted net income guidance to between $50 million and $60 million. That concludes my prepared remarks. And I’ll now turn the call over to the operator who will begin the question-and-answer session.

Jim Molloy, Analyst, Summer Street

Thank you, Jim. I appreciate your participation on the call. Regarding the RSDL, let me first address the second question before handing it over to Adam. It is true that there is a request totaling $6 billion that has been sent. Approximately $155 million to $160 million has been allocated specifically to BARDA for the development of medical countermeasures, therapeutics, and vaccines. Depending on Congress's actions, that may represent the additional funding for BARDA beyond what has already been allocated for the Ebola crisis. I hope that clarifies things. Adam, could you address the question about RSDL?

Adam Havey, EVP and President, Biodefense Division

As you can tell, Jim, as our portfolio has grown and expanded, we’re going to focus on BioThrax sales. That's a primary driver and kind of catering all of our other product sales really in other sense. We're not going to build that level of granularity as we move forward. So that's something we have to kind of estimate on a gross level with the additional products in our portfolio.

Dan Abdun-Nabi, President and CEO

Yes. And a little bit more clarity on Adam’s, specific products start to gain additional market channel become larger and larger in terms of their revenue generation. We will get greater visibility as they become bigger in percentage with the total revenue overall.

Jim Molloy, Analyst, Summer Street

Thank you for that. I have a couple of quick follow-up questions. Research and development costs decreased significantly, which seems positive. Is that decrease sustainable, and what is the actual spending level? Most of the R&D expenses are related to contract grants reimbursed, correct? Additionally, can you explain the increase in fully diluted shares this quarter and whether we can expect steady levels moving forward?

Bob Kramer, EVP and Chief Financial Officer

Jim, this is Bob. So, on the R&D for the quarter, the net R&D reflects clearly the netting of the $15 million MorphoSys upfront payment. So, you shouldn't expect us to have essentially zero net R&D on a quarterly basis going forward. But as we talked about on prior calls our emphasis is on continuing to manage R&D costs looks for opportunities to partner certain technologies like the ES414 candidate and gradually walk that net R&D number as a percent of our revenue down from historical levels of 20% to 25% down to a high teens number. So we'll continue to make progress there.

Dan Abdun-Nabi, President and CEO

I'll add just a comment to that, Bob. Jim, as you know it's been a priority for us to partner these assets and initially we've been spending quite a bit of time on that partnering and it turned that ES414 was the first to get across the goal line. So, this remains a focus for us across the portfolio and actually for the prior quarter itself, we think that the ADAPTIR platform being bi-specific is the state-of-the-art, it's a very interesting platform. So to Bob’s point, can't expect to see this on a regular basis, but it is a part of the way in which we intend to operate our business. So, don't be surprised in the future when we announce deals that are around partnering particular assets or the platform as a whole.

Bob Kramer, EVP and Chief Financial Officer

And Jim on the question about fully diluted or the weighted average number of shares, in the quarter, we're reflecting the impact of the convert shares. We did not include them last time because we had a net loss cumulative as of the end of six months. So, it was inappropriate for us to reflect those fully diluted weighted shares.

Jim Molloy, Analyst, Summer Street

Excellent. And I guess the last question, should we be expecting another acquisition to get to the $500 million at some point here in 2015?

Dan Abdun-Nabi, President and CEO

It's a great question. The short answer is yes, we are considering acquisitions. It's not just about reaching the $500 million target; it's about how we want to build both businesses. Currently, we have identified several interesting targets for both Biosciences and Biodefense, and some of these could significantly contribute to our revenue and earnings. I am quite excited about the opportunity to complete these transactions. However, as you know, this process takes time, and we need to be patient and careful. We have specific metrics and criteria in place; we won't pursue an opportunity if it doesn't align with our shareholders' interests. If we can't agree on terms we find acceptable, we'll walk away, which we've done before. So, we continue to be active but cautious in our M&A strategy.

Jim Molloy, Analyst, Summer Street

Great. Thanks for taking my questions.

Marc Frahm, Analyst, Cowen & Company

Hi, and thanks for taking my question. And just kind of housekeeping on Building 55 as we move towards approval. Do you guys expect to kind of press releasing when these major steps are finished or just are we going to have to wait until the application is complete?

Dan Abdun-Nabi, President and CEO

We remain active but prudent in our approach to mergers and acquisitions. Thank you for your questions about Building 55. Do you expect to issue press releases when significant milestones are reached, or will we need to wait until the application process is fully completed?

Marc Frahm, Analyst, Cowen & Company

Okay. And then also as we all are anticipating it eventually being approved, when could we expect to see some movement on kind of negotiating the next contract for BioThrax and will that necessarily include the Building 55 or might it happen sooner or I mean that can reflect that excess capacity?

Dan Abdun-Nabi, President and CEO

Yes, it’s a great question. Our experience with the CDC has been that we expect to begin discussions with them once the application process starts. They will likely want to wait until we are closer to finalizing the application before engaging in discussions. Additionally, there will be some lead time involved in any contract negotiations. This is an area where we may not be able to provide detailed visibility to investors, as those discussions are confidential. However, we do anticipate making progress throughout next year, potentially beginning those discussions as early as the second quarter of next year.

Marc Frahm, Analyst, Cowen & Company

Okay. And then there has been some hope that you could start selling more to non-U.S. governments. Will all of us kind of have to wait until we have a new U.S. contract or can you do that in parallel?

Adam Havey, EVP and President, Biodefense Division

Yes. So Marc, this is Adam Havey. So we would do that in parallel. Obviously, the upside in capacity in 55 really creates, I’d say even more opportunity internationally. But as we’ve mentioned in the past, we continue to work on expanding our reach internationally, if you will, BioThrax, for BAT, for AIG, for VIG, and RSDL. So that’s the major focus for us right now and will continue to be a focus in 2015. We think we can build some demand in those markets prior to approval of Building 55 and we’ll continue to see movement there in 2015.

Marc Frahm, Analyst, Cowen & Company

Okay. And then finally back to the Ebola task order, is something of that going to be contingent on the funding request from Obama getting filled by Congress or does BARDA have enough money sitting around right now to settle this request?

Dan Abdun-Nabi, President and CEO

So, that's a great question. BARDA does have funds. We don't have complete transparency in terms of exactly how much they have and how much they will be allocating to each of the activities they have underway. And as you can appreciate, this is a fairly expensive program that they're launching here. My suspicion and I think it was just common sense, they all have adequate funding to do everything that they would like to do, but they do have funds in order to get these programs started and then they will continue to fill that pipeline through additional appropriations as they materialize from Congress.

Marc Frahm, Analyst, Cowen & Company

Okay. Thank you very much.

Randy Scherago, Analyst, LaSalle Street Capital Management

Hi everyone, great quarter. I have a couple of housekeeping questions. Regarding the facility in Winnipeg, will that be a write-off or neutral to earnings moving forward? Also, can you provide clarity on what you are doing with IXinity? Are you starting or discontinuing that program, and will there be costs associated with it? Lastly, is the recent shutdown of Building 12 in Lansing a normal occurrence, and are you back up and running with BioThrax production?

Bob Kramer, EVP and Chief Financial Officer

All right, Randy, this is Bob. I'll take the first part and then I think Barry will answer the second and probably Adam the third, so you get three of us in a row here. I think on the write-down or the sale of the facility in Winnipeg, there may be a small gain, but it won't have a material impact on our statements overall.

Barry Labinger, EVP and President, Biosciences Division

Okay. And the question about IXinity; as you know, we received a complete response letter from the FDA at the end of July when we reached our PDUFA date. We've since had discussions with the agency and reached resolution on the content of the response to that which we have submitted. So the program is back under review and if the review is completed successfully then we do plan to launch this product in 2015. There is no additional cost associated with responding to the issues that were raised in the CRR. So, we have some ongoing studies that we've had in place anyway and we'll continue and it’s post-marketing commitment and we've had some preparation for the launch on the commercial side, but all consistent with the plan, we just had a bit of a delay in getting through approval on the launch.

Randy Scherago, Analyst, LaSalle Street Capital Management

Would the launch be late 2015?

Barry Labinger, EVP and President, Biosciences Division

More around the middle of 2015.

Adam Havey, EVP and President, Biodefense Division

So, as you mentioned we really shutdown and we've successfully come out of the shutdown, actually came out a few days early and things look great moving forward.

Randy Scherago, Analyst, LaSalle Street Capital Management

Great. Thank you, guys.

Bob Burrows, VP, Investor Relations

Thank you, Denise. With that ladies and gentlemen, we have concluded the call. 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 an available webcast of today's call, an archived version, which will be available later today accessible through the company 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 everyone.