Dyax Corporation CEO Discusses Q3 2012 Results - Earnings Call Transcript

| About: Dyax Corp. (DYAX)

Dyax Corporation (NASDAQ:DYAX)

Q3 2012 Earnings Call

October 24, 2012 05:00 PM ET


Jen Robinson - IR

Gustav Christiansen - President & CEO

Rick Berard - SVP, Commercial

Burt Adelman - Chief Medical Officer

Ivana Magovčević-Liebisch - COO & EVP

George Miguasky - EVP, CFO


Joseph Schwartz - Leerink Swann

Phil Nadeau - Cowen and Company

Serge Boulanger - Needham and Company


Good afternoon and welcome ladies and gentlemen to Dyax Corp’s Third Quarter 2012 Financial Earnings Call. (Operator Instructions). Before turning this call over to Gustav Christiansen, President and Chief Executive Officer of Dyax. The company will now read their Safe Harbor Statement.

Jen Robinson

This afternoon, Dyax issued a press release concerning its third quarter 2012 financial results. Dyax would like to remind everyone that statements made today reflect current expectations, estimates and projections about its products, programs, collaborations, strategies and financial performance, and are forward-looking statements. These statements, including those related to Dyax’s FDA-approved product KALBITOR, are subject to risks and uncertainties that could cause actual events and results to differ materially. Important information concerning these risks and uncertainties is contained in Dyax’s press release today, and described or referred to in its most recent form 10-K and other periodic reports filed with the SEC, and are also available on the company’s website at www.dyax.com. I will now turn the call over to Gustav Christiansen, President and CEO of Dyax. Gustav?

Gustav Christiansen

Thank you Jen. And thank you everyone for dialing in to our third quarter 2012 earnings call. Today we will see an update in our business including KALBITOR, the angioedema portfolio and the Licensing and Funded Research Program. The foundation of our angioedema portfolio is built on the success of our lead product KALBITOR, approved to treat acute attacks of hereditary angioedema or HAE. KALBITOR has proven to be a consistent and growing revenue generator now for 10 consecutive quarters with net sales of $10.8 million for the third quarter which is an 18% increase quarter-over-quarter and continued increase in the number of patients treating with KALBITOR up 15% over last quarter.

Dyax’s other key value driver, their Licensing and Funded Research Program continues to provide revenue through licensing fees and milestone payments and have significant future potential due to its broad and maturing pipeline of clinical candidates which address large high value therapeutic markets. For more detail on these key business areas I will now turn the call over to our executive management team. First Rick Berard, Senior Vice President, Commercial will discuss our ongoing marketing efforts for KALBITOR in the U.S. Dr. Burt Adelman, Chief Medical Officer will discuss our research initiatives in the angioedema portfolio. Dr. Ivana Magovčević-Liebisch, Chief Operating Officer will discuss our global expansion efforts for KALBITOR as well as the Licensing and Funded Research Program and finally George Miguasky, Chief Financial Officer will present our financial highlights and financial guidance.

Following these updates I will provide concluding remarks and then open the line for Q&A. At this time I’ll turn the call over to Rick who will review the progress of KALBITOR in the U.S.

Rick Berard

Thank you Gustav and good evening. Our commercial team continues to work diligently on three key objectives, patient identification, patient treatment and retreatment. Through our first class patient service and support offerings we continue to drive KALBITOR to strong quarter-over-quarter growth. In the third quarter, KALBITOR net sales were $10.8 million, an 18% increase over the prior quarter. As of September 30, 596 patients have treated with KALBITOR, an increase of 78 patients or 15% quarter-over-quarter. The KALBITOR treatment rate remains between 6 to 9 treated attacks per year and patients using the KALBITOR patient supply drug program are showing treatment rates at the top or above our treatment range.

The foundation of this growth is supported by KALBITOR Care, our robust patient service and support program. It's major components include the KALBITOR access hub which focuses on reimbursement, financial assistance and nurse-out reach for individual patient education. Treatment size and production distribution options including patient supply drug and KALBITOR home infusion services.

Genetic counseling and support for diagnostic testing in physician and patient education programs. These comprehensive and innovative offerings continue to differentiate Dyax as the leader in the HAE space and we remain dedicated to providing patients and healthcare professionals with unparalleled resources to increase disease and treatment awareness as well as support the management of acute attacks of HAE.

One program that continues to distinguish Dyax is KALBITOR home infusion services. Entering its second year, this program continues to grow in popularity with new patients, the majority of whom are selecting this treatment option. KALBITOR home infusion services offers monitored, convenient, on-demand treatment in the comfort of the patient’s home with the help of a qualified and knowledgeable home infusion nurse.

Patients participating in KALBITOR home infusion services report a high degree of satisfaction with the program as it provides convenience, prompt treatment and the reassurance of a trained healthcare professional. The majority of these nurses arrive at the patient’s home within an hour of being contacted. The program also benefits patients through timely feedback from the nurses to the patients treating physician. Physician in turn find this feedback useful in managing the patient’s condition and have found that KALBITOR home infusion services enhances interaction with patients.

In addition to gaining valuable information on how to best manage patients overall HAE treatment, physicians also appreciate the fact that patients are being treated and monitored by a trained infusion nurse rather than having to make treatment decisions on their own during a stress of an acute attack. This individualized, high-touch program is one example of what truly sets KALBITOR service and support program apart from other HAE treatment options.

Another program that has received positive feedback from the HAE community is our free genetic counseling program. Since launching in the second quarter of this year we have had active patient participation in this service. To this program we are able to educate patients and their families about HAE and help them understand that genetic implications of this disease.

These types of programs are instrumental in identifying new patients and growing the HAE market which to this day remain significantly under penetrated. In fact we estimate that approximately 60% of identified patients are still not benefiting from novel therapies.

We believe that the clinical benefits of KALBITOR combined with this sizeable market opportunity will translate into consist, positive growth in the KALBITOR business. At this time I will turn the call over to Burt to provide updates on the emerging aspects of our angioedema franchise.

Burt Adelman

Thank you Rick. Good evening everyone. The successful development and clinical use of KALBITOR validated plasma kallikrein as an important therapeutic target in HAE. During an HAE attack, plasma kallikrein activation is initiated by small amounts of factor 12A which (inaudible) prekallikrein to plasma kallikrein. Once plasma kallikrein generation begins it then acts to produce more factor 12A which in turn rapidly accelerates formation of additional amounts of plasma kallikrein, (inaudible) is then generated by this abundant amount of plasma kallikrein and ultimately causes angioedema. This feedback loop defines the central role of plasma kallikrein in driving a tax of hereditary angioedema.

At Dyax, our understanding of this pathway has led us to focus on plasma kallikrein inhibition as the most logical strategy to both treat and prevent HAE attacks. To do the ladder we are developing DX-2930, a fully human monoclonal antibody directed against plasma kallikrein. DX-2930 was identified from our proprietary phage display library and we are moving it toward clinical trials.

Preclinical development of the DX-2930 has demonstrated that it has high specificity and affinity for plasma kallikrein. Early studies in non-human primates indicate that DX-2930 is likely to have a long half-life in humans. Development work has led us to formulate DX-2930 for subcutaneous self-injection. We are currently planning to file an IND for DX-2930 in mid-2013 and begin Phase I studies shortly thereafter.

Our goal is to develop 2930 as a true prophylactic agent allowing patients with hereditary angioedema to be attack free. We believe that pathologic generation of plasma kallikrein may contribute importantly to a number of serious clinical conditions related to hereditary angioedema. These disorders include Type 3HAE and some forms of idiopathic angioedema. What has been missing in the evaluation of individuals with these problems is a diagnostic test that can determine if plasma kallikrein generation is occurring when clinical symptoms are present.

We have been working hard in this problem and now believe that we can construct a (inaudible) based assays that will deduct plasma kallikrein in patient blood samples. Our current plans are to begin validation of these assays and conduct preliminary patient sample testing by the middle of next year. Accurate identification of patients whose underlying angioedema is driven by plasma kallikrein will enable us to conduct clinical trials of KALBITOR and possibly even DX-2930 in these groups of patients who currently have no approved, disease specific therapies available to them.

Increasing evidence suggest that plasma kallikrein may contribute to serious clinical problems that are not commonly considered under the umbrella on angioedema. We at Dyax follow this emerging area with great interest and we hope that the application of the diagnostic assay we described above will help to advance this field. So in conclusion we are making great progress to an extending our reach across the spectrum of clinical disorders that maybe wholly or in part driven by plasma kallikrein generation. I will now turn the call over to Ivana.

Ivana Magovčević-Liebisch

Thank you Burt. First I would like to quickly update you on the progress we’re making outside the U.S. and bringing KALBITOR to HAE patients around the world. Recently our partner in the middle-east Taiba hosted a successful symposium to help educate physicians and patients on HAE. We’re excited to work with our partner to bring a novel HAE therapy to this part of the world and expect to have our first ex-U.S. sales from the middle-east in the fourth quarter of this year.

Our partner in Japan, CMIC is in track to begin a 10 patient open label study this quarter assuming successful completion of this study CMIC could begin marketing KALBITOR as early as 2014. With this I will shift to the Licensing and Funded Research Program or LFRP which is based upon our gold standard phage display technology and is one of the most successful licensing programs in the industry today.

There are three distinct types of licenses or collaborations under the LFRP. Patent licenses, library licenses and funded research agreements. The first type of license, (inaudible) license, grants licenses the right to use a phage display patents in conjunction with their own libraries.

The patent associated with these licenses are set to expire in November of 2012, as such we are no longer entering into these agreements. The revenue generated from these agreements comprises of very small percentage of total LFRP revenues and therefore does not play a material role in our future expectations for the LFRP.

The second type of license we offer is the library license which gives our licenses right to use our proprietary phage display libraries in connection with their internal therapeutic development programs. These libraries are protected by patent portfolio of which the last patent is scheduled to expire in 2024. The third type of arrangement under the LFRP is our funded research agreements. We have performed funded research for various partners using our phage display libraries to identify, characterize and optimize anti-bodies that bind to their specific disease targets.

Importantly these two types of LFRP arrangements, the library licenses and funded research agreements comprise the majority of our candidate portfolio and are strategically designed to provide royalty payments, 10 years beyond the products for its commercial sale regardless of patent exploration.

It is these types of agreements that are currently in place with multiple biopharmaceutical companies including Amgen, Bayer, Baxter, Biogen Idec, and Eli Lilly. We currently have 11 clinical stage compounds, three in Phase III and four in Phase II as well as 18 preclinical candidates associated with our library licenses and funded research agreement. Among the Phase III candidates is Ramucirumab, a fully human antibody targeting the VEGFR-2 receptor from Lilly.

Last week Lilly announced positive Phase III data from their REGARD trial in gastric cancer. These data indicate that patients of Ramucirumab as second line therapy for metastatic gastric cancer had prolonged progression free survival and importantly improved overall survival.

Lilly has described Ramucirumab as one of the key molecule in its pipeline representing one of the largest clinical programs currently underway at Lilly with six Phase III trials ongoing around the globe. We expect additional readouts for a number of these trials next year and beyond. This is an exciting time for the LFRP business with several pivotal data read outs on the horizon for products with blockbuster potential. As a result we see the LFRP as a key growth driver with a potential for significant future revenue. The angioedema portfolio and our LFRP business are the center of Dyax’s strategy and the focus of our resources and investments going forward. As we announced at the beginning of this year we have been working to out license early stage assets that we do not fall under these two categories and effort which has begun to bear fruits.

In September we announced the strategic license agreement with Kadmon Corporation in which Kadmon has granted an exclusive worldwide license for the development and commercialization of the fully human monoclonal antibody, DX-2400, a potent and selective inhibitor of matrix metalloproteinase 14 (MMP-14). MMP-14.

Under the terms of the agreement, the actual receive an upfront payment and is eligible for significant development and commercial milestone payments in addition to upto double digit tier royalties on commercial sales.

We will continue to take advantage of opportunities that are license non-core, existing preclinical candidates and look forward to giving you more information on these new partnerships in the future. At this time George will walk you through our financial highlights. George.

George Miguasky

Thanks Ivana. I hope you all have had a chance to read out press release on Q3 results which was issued after market closed today. First I will take you through our third quarter 2012 financial results and then review our financial guidance. As reported this afternoon, our total revenue for the third quarter 2012 was $13.1 million compared to 10.1 million for the same quarter in 2011.

This revenue increase is due to our growing KALBITOR net sales which for the third quarter of 2012 were 10.8 million as compared to 6.6 million last year. The sales in Q3, 2012 are net of adjustments of approximately 6.8% of the gross sales. It's noteworthy that KALBITOR net sales have consistently grown quarter-over-quarter, marking the 10th sequential quarter of growth and it reflects the steadily growing number of patients treating with KALBITOR.

It also brings net sales for the nine month period ending September 30, 2012 up to $28 million and the total revenue for the nine months is 38.6 million. Operating expenses for the third quarter up 2012 were 15.8 million down from 17.7 million last year, within operating costs are research and development expenses which include KALBITOR medical support and post marketing requirements. Development of the single injection formulation of KALBITOR, development costs associated with DX-2930 and pass through license fees take by Dyax licensees under the LFRP.

R&D costs for the third quarter of 2012 were reduced to $6.2 million as compared to 8.7 million last year. For the nine month period ending September 30, 2012 R&D cost were 22.7 million versus 26.2 million in 2011. The third quarter and nine months of 2012 reflect reduced expenses due to lower clinical trial and personnel costs as well as a reduction in pass through license fees paid by Dyax licensees under the LFRP.

Selling, general and administrative costs, which include commercial costs for KALBITOR were $9.1 million in the third quarter of 2012 and 29.9 million for the nine month period as compared to 8.8 million and 27.1 million respectively for the same period last year. For the third quarter of 2012 Dyax reported a net loss for 5.2 million or $0.05 per share. This compares to a net loss of 9.7 million or $0.10 per share in 2011. For the nine months ending September 30, 2012, Dyax net loss was 24.4 million or $0.25 per share as compared to a net loss of 21.1 million or $0.21 per share for the same period in 2011.

Now with respect to our cash resources, as of September 30, 2012 Dyax had cash, cash equivalent and short term investments totaling 30.4 million exclusive of restricted cash. Our operating cash burn in the third quarter decreased to $5 million down from 7 million in the preceding second quarter and 8.5 million in Q1.

With costs carefully planned and with achievable sales growth for the year, our occurring operating cash burn is expected to continue to decline both quarterly and annually. Now turning to our financial guidance, we are reiterating our 2012 guidance of top-line total revenue of $50 million to $54 million.

This guidance includes KALBITOR sales of 36 to 40 million and we now believe 2012 sales will be at the upper end of this range. Additionally this guidance excludes any potential revenue for new KALBITOR license arrangements or from any ex-U.S. KALBITOR sales. We are also reiterating our guidance to reach cash flow breakeven during 2013.

To review how we get there, as mentioned KALBITOR sales are expected to grow to the upper end of the $36 million to $40 million range. We expect the KALBITOR business to be profitable and generating positive cash flow for 2012 as it did in the third quarter. Our operating costs from R&D and SG&A will increase by less than 2% in 2012 and the quarterly operating cash burn continues to decline as it has every quarter during 2012 and 5 million in Q3.

So now back to Gustav.

Gustav Christiansen

Thank you George. By all accounts, 2012 has thus far been a year of accelerating value creating. We had another strong quarter across our key metrics in the KALBITOR business and are on track to meet the upper end of our KALBITOR guidance for 2012.

Our strategy and our goals are clear and focused and our resources are aligned around driving both near and long term growths. In our KALBITOR business, we have established a successful strategy of including and treating patients with HAE. The core of our strategy has come from listening to our patients and their treating physicians and delivering them a great product, a robust set of services and support programs. We expect to build on our momentum by delivering consistent revenue growths and continuing to establish KALBITOR as the treatment of choice for acute HAE attacks.

Continuing to strengthening our angioedema portfolio by expanding our suite of products and programs to better diagnose and treat a broader range of angioedema patients. Building the LFRP by adding new licensees and enhancing an already robust pipeline and lastly reaching our financial goals to become cash flow breakeven during 2013.

As we focus our attention and resources on these high value areas. Dyax is well positioned to provide growth and significant shareholder value for many years to come. We look forward to updating you on our progress. With that I will turn the call over to questions. Operator?

Question-and-Answer Session


(Operator Instructions). Our first question comes from Joseph Schwartz from Leerink Swann. Your line is open.

Joseph Schwartz - Leerink Swann

I was wondering first on the LFRP in terms of the royalty rate, or the royalties as they are structured. Is that based on U.S. sales only or is that on global sales, if you can remind me of that.

Ivana Magovčević-Liebisch

So those are on worldwide sales and they are 10 years from first commercial sale.

Joseph Schwartz - Leerink Swann

And then I couldn’t help to pick up on Burt’s statement that you would hope that the DX-2930 would allow patients to be attack free, that’s a pretty bold statement and it could certainly be a huge advance, what gives you that confidence and would that help you as you, it would seem to help you have a ton of statistical power in a clinical trial environment. So what sort of a regulatory pathway, how long would the runway have to be to get a drug like that approved?

Gustav Christiansen

So you know as I said, we believe that through the development of KALBITOR we have demonstrated that plasma kallikrein is evaluate. We are getting a lot of feedback. We think that through the discovery and development of KALBITOR we have clearly validated that inhibition of plasma kallikrein is an important target for effective treatment of HAE and I don’t think there is a publication literature that doesn’t indicate that plasma kallikrein generation is central to the disease. So I don’t think it's a great leap of faith to believe that effective blockade of plasma kallikrein generation should be able to prevent HAE attacks and we think the trick to really effective prophylaxis is having a drug that has a well-mannered pharmacokinetic profile and as I know you’re well aware monoclonal antibodies tend to have very predictable relatively long half-life and the way to prevent an attack is to be able to give patients a drug that will have a consistent pharmacokinetic profile. The blood level can be easily managed at the right therapeutic dose.

So we’re very excited about that and I think look the word, to use the term prophylactic I think implies that you’re going to have very significant effect on the attack rate. So you know that’s our thinking on that. So the answer to the second question you know what would the development strategy be, I think you know you’re correct to assume that it doesn’t take 100s of patients to approve that degree of efficacy but I’m not going to begin to predict what regulatory pathway ultimately would be. We got to sit down with the FDA and the EMEA and talk about that in detail.

Joseph Schwartz - Leerink Swann

And then on the diagnostic that you’re seeking to develop. How do you envision that coming to market, would that be a product that you would offer or is this just technology that you’re fostering? What are your thoughts there?

Gustav Christiansen

I think we’re taking this one step at a time, the step we’re at right now is actually trying to build and fully validate reliable assay platforms and I think we are making great success in that direction. And then the next step would be to use those assays to help us better define the path of biology of angioedema disorders that are not classic hereditary angioedema so that we can determine whether they are as yet unidentified groups of patients that would benefit from KALBITOR or 2930. I don’t think we have even begun to think about you know commercialization, although we are drug company, we are not a diagnostic company. So I think our hope would be to make these kinds of test readily available in formats that one or more commercial provider might be interested to pick up and provide to the community just as C4 and C1 inhibitor assays are currently available.

Joseph Schwartz - Leerink Swann

Are people using these tests already? You said those were (inaudible) based blood assays.

Gustav Christiansen

There are no tests available, even in experimental settings. I mean we’re literally working from ground up to build these assays and validate them and demonstrate to the community that they can be used usefully.


Our next question comes from Phil Nadeau from Cowen and Company. Your line is open.

Phil Nadeau - Cowen and Company

First looking forward on with KALBITOR sales. In the last two years, the sequential growth Q4 over Q3 said to be somewhat lower than the rest of the year, is there a reason to think that there could be Q4 seasonality and KALBITOR or where there any idiosyncratic factors in those prior two years like the launch of (inaudible) last year.

Ivana Magovčević-Liebisch

I don’t think I want to subscribe anything to (inaudible) launch, so I don’t think that has anything to do with it. Yes we have noted that in the past the question is, is there some seasonality to this disease potentially you know, you’re also talking about holiday season but we are very confident that our growth is going to continue from the third to the fourth quarter and that’s why we said that our guidance is in the upper range of what we put out there. So I wouldn’t really put too much emphasis on that variability.

Phil Nadeau - Cowen and Company

And then second, an housekeeping item, in the past you have given us the number of patients with drug placed, will you disclose where that stood in Q3?

Ivana Magovčević-Liebisch

I don’t think, we are trying to get away from that level granularity. As you know we are in a very competitive space today. So all I can tell you is that the numbers as you can see if revenue continues to grow obviously the revenue comes from patients and their treatments and retreatment. So this what we are showing you is true demand. So I would like to leave at that for now.

Phil Nadeau - Cowen and Company

Okay and on the new genetics – people who are assessing the geneticist. Can you give us some sense of how that is growing the market or proportion of patients are being newly diagnosed or some number of patients that are been newly diagnosed because of the genetic test or is it just too early have this sort of estimates.

Ivana Magovčević-Liebisch

So I think it's obviously early, it's been launched recently but what I can tell you would definitely through the family trees, it is what we expected to see is that this is out of normal dominant disease and there are a significant number of family members that are affected with the disease I don’t want to put any percentages or numbers out there because it's early but I think this will be one of the tools that will be very useful in identifying new patients and as you know this market is only about 30% penetrated today. So there is still a lot of 30% to 40% penetrated, so there is still a lot of opportunity here and we think this is good way to identify new patients.

Phil Nadeau - Cowen and Company

Okay last question is just on the upcoming LFRP data releases, has Lilly been specific about the Ramucirumab Phase III trials and when exactly they might read out next and which ones we will read out next.

Gustav Christiansen

I don’t think beyond the clinicaltrial.gov. I mean these are the primary completion dates, all on there. In the press release they did talk about that the segment gastric cancer trial would end in the fall of 2013 and they expect to release those data at meetings in early 14 if I don’t remember wrong, I think that’s what exactly what they actually said in the press release. So we follow the clinicaltrial.gov and the changes that is happening there.


Our next question comes from Serge Boulanger from Needham and Company. Your line is open.

Serge Boulanger - Needham and Company

Just a couple of housekeeping questions. There is sizeable drafts in both R&D and SG&A during the quarter, do you still expect operating expenses to grow 5% over 2011 levels?

George Miguasky

Actually as it was described in call itself, we expect to operating expenses would be less than 2% growth in 2012 over 2011. So a very modest increase there and not 5%.

Serge Boulanger - Needham and Company

All right, the levels reported this quarter what we should expect the base figure from in terms of R&D?

George Miguasky

So it may not be what you would call base, you know what happens this quarter of course is that there is no more clinical trials cost associated with the ACE trial and there are some lower LFRP pass-through fees but as we transition now through or the activities around the DX-2930 antibody and heading toward and I&B filing in ’13 and those types of cost I think you will see that the cost levels continue at a steady rate, not a growth rate but at a steady base rate.

Serge Boulanger - Needham and Company

Okay and then can you update us on post approval commitments and do they constitute the most of the R&D spend?

George Miguasky

So the R&D spend has a number of elements, certainly the post marketing requirements is one of them. But also in there is medical support around the KALBITOR front as well as the DX-2930 cost and LFRP tests are across and so there is a number of components but the post marketing requirements well they are a piece of it is not a substantial piece of it.

Serge Boulanger - Needham and Company

Okay and what still needs to be done in terms of those requirements? When does it end or where are you in terms of updates?

Gustav Christiansen

We have got some clinical activities that I believe end in around 2014 and we are working on that and there are the usual safety updates which we are sort of getting toward the end of frequent safety updates but there is always going to be ongoing costs.


This will end our Q&A session for the day. I will turn it back to Gustav Christiansen for closing remarks.

Gustav Christiansen

Well I want to thank everyone for dialing into this third quarter earnings call and we are looking forward to update you in the quarters ahead. Thank you very much and have a good evening.


Ladies and gentlemen thank you for participating in today’s program. This concludes the program. You may all disconnect.

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