OPKO Health (OPK) Q2 2015 Results – Earnings Call Transcript – SoundCloud Webcast

OPKO Second Quarter 2015 Financial Results – Earnings Call Transcript – Uncle’s SoundCloud Webcast

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Operator

Good afternoon and bid ~ to the OPKO Health’s Second Quarter 2015 Earnings Call. Today’s figure is being recorded. I would things being so like to turn the conference across to Executive Vice President of Administration, Steve Rubin.

Steve Rubin – Executive Vice President of Administration

Thank you and admirable morning. Before we begin, I’d like to put in remembrance you that any statements made during this call which are historical will be considered forward-looking, and in the same proportion that such will be subject to danger and uncertainties which could materially aspire to our expected results, including without limitation the various risks described in our Annual Report forward Form 10-K for the year ended December 31, 2014 and our succeeding filings with the SEC.

I’d like to reason about the format for today’s designate. Adam Logal, our Chief Financial Officer testament first talk about our financial and operating results on the side of the quarter. Jane Hsiao, our Vice Chairman and Chief Technical Officer decree then provide a brief update forward our Biologic Programs. Charlie Bishop, the CEO of our Renal Division would nearest provide a brief update on our Rayaldee progress to maturity program; followed by David Okrongly, President of our Diagnostics Division, who direct provide an update of our diagnostics projects. And finally Dr. Frost will follow-up by a brief wrap-up. We effect have the entire team here through us to answer any questions you efficiency have after our remarks.

And by that, I’ll turn it in excess to Adam Logal our CFO. Adam.

Adam Logal – Chief Financial Officer

Thank you Steve and capital afternoon everyone. We ended June through a cash balance of $221 a thousand thousand reflecting the $295 million upfront settlement received from Pfizer for the hGH-CTP Global Collaboration Agreement, partially offset by cash used in our acquisition of EirGen as well as cash used in our continued investment in Research and Development during the primeval half of 2015.

We strengthened our weighing sheet during the first half of 2015 ~ the agency of exchanging approximately $41 million of our 30% convertible notes for shares of common lay up. Both the Pfizer transaction and the interchangeable notes continue to have a indicative impact on our results of operations in favor of the first half of 2015.

As a consequence of the significant increase in our part price since December 31, the more than middling value of the embedded derivative associated with our convertible debt increased and to the degree that a result we recorded non-specie charges in other income and expenses with respect to the three and six months ended of approximately $70 million and $66 million particularly.

Importantly, this non-cash expense is the accrue of our share price depreciation and by the exchange of $41 million of essential notes during 2015 future changes in our portion price will have a lesser impression. Further, the remaining $46 million of most considerable notes continue to be convertible through the holders through September 30 similar to our share price exceeds the predefined employment premium under the indentures.

During the six months ended June 30, 2015 we furthermore recorded a nonrecurring operating expense of approximately $26 million related to our hGH-CTP technology, considered in the state of we license that technology out of Israel triggering a repayment agreement to the Israeli Office of the Chief Scientist. The OCS own previously funded a portion of the exhibition of our hGH-CTP program. Further we admit $17.7 million and $30.2 million of revenue during the three and six month periods cognate to the Pfizer collaboration agreement. As a reminder we are recording $295 million up-front payment as revenue up~ a straight line basis over the anticipated unfolding period.

Revenue during the three months ended June 30, 2015 increased approximately $19 million to $42.4 million, principally as a result of the reward recognized in connection with the Pfizer proceeding and revenue generated by EirGen situation acquisition.

Revenue for the first six months of 2015 increased $26.7 the masses to $72.5 million as a end of revenue recognized for Pfizer and EirGen, partly offset by lower revenue OPKO Health Europe of the same kind with we negotiated a long term take the place of range with one of our customers viewed like well as plant temporary shutdown at our OPKO Mexico manufacturing means. The arrangement at OPKO Health Europe was completed for the period of the first quarter and the manufacturing flexibility in Mexico was also brought back online during the first quarter.

As a decision of the prior items, including the non-cash derivative expenses and the non-recurring person time repayment to the OCS, clear loss for the three months increased $17 very great number to $43 million and for the six months clear loss increased $90 million to $160 million in comparison to the 2014 conclusion.

In addition, we continue to enclose on our R&D programs and viewed like such R&D expense increased against the three months ended June 30, 2015 ~ means of $13.3 million to $29.6 million and R&D expense concerning the six months ended June 30, increased ~ the agency of $17.8 million to $55.1 the public.

I would now like to be transformed the call over to Jane Hsiao, our Vice Chairman and CTO. Jane.

Jane Hsiao – Vice Chairman, Chief Technical Officer

Thank you, Adam. I consider had the pleasure of working by the OPKO Biologics team since the acquisition. I would speak that I am very proud to recite OPKO Biologics based in Israel is one extremely productive team. The team is laboring tirelessly to appraise the proprietary technologies, to reach out the half-life to therapeutic peptides and proteins. The greatest part advanced program is that once a week injecting instead of once daily common in human bourgeoning hormone product.

Since the beginning of this year the house with Pfizer has given this scheme a boost in building commercial prosperity. We have an expanded and accomplished the resources from Pfizer and we calculate upon to have very favorable cost of commodities structure.

We have completed enrolment of the turning Phase 3 study for the method of treating of growth hormone deficiency in grown up patients. We plan to file the biological give a permit application as soon as the facts cleanup and compilation can be completed.

All 52 worthy of choice patients have competed the 12 months directory treatment period of the Phase 2 pediatric prescribed portion ranging study and of that from one to another 90% of the patients have elected to last receiving the treatment in the clear level phase of the trail. Some patients level gone into the second years of management.

OPKO and Pfizer teams are in operation together to develop the Optimum Global Regulatory Strategies in the place of the U.S., Eastern and Western Europe and Asian particular countries. Recently we also consulted by PMDA to discuss registration requirements on this account that Japan, which holds about one-third part of the total market and has its admit unique regulatory pathway. We expect our intense long term Phase 2 data in pediatric advance hormone deficiency patients will facilitate the progress to maturity timeline in Japan.

The second program is a Long Acting Factor VIIa. This is a recombinant consequence using the same CTP technology being of the kind which that for the growth hormone result to extend the half-life of Factor VIIa. Some Hemophilia patients A or B patients who take developed antibodies to their factor re-establishment therapy and become unresponsive are treated through Factor VIIa, which is dominated ~ dint of. Novo Norodisk, NovoSeven product. The reported mart size of this product is $1.2 billion to $1.6 billion a year. Our produce MOD-5014, studied side by faction to NovoSeven has shown the possible in anymore model studies for each on demand and prophylactic use by IV and the more importantly ~ the agency of Subcu.

In June five postures were accepted and presented at the International Society adhering Thrombosis and Haemostasis Annual Meeting in Toronto, Canada. We presented the Clinical Toxicological, pharmacokinetics and pharmacology with comprehensive assessment of the safety and power of our product in animals. This premises set is the basis of the FDA approved IND to prop its first in Human Trial of this effect. We expect to dose the primitive patient as a Phase 2a dose escalating study as soon as the needful IND approval and external laboratory religious rite contracts are in place.

Another fruits which is almost ready for primitive clinical study is the Long Acting Oxyntomodulin. Oxyntomodulin is a peptide hormone released from the gut after a meal. It activates the two the glucagon-like peptide-1 and glucagon receptor and is known to master the food intake and to become greater energy consumption for an effective moment loss control. The half-life or sum of attributes of such a module is in minutes, time of course modified along acting products be possible to be administered once a week.

Studies in diabetic overweight mice possess demonstrated greater weight loss than the greater hormone itself. We are completing the requisite toxicology and pharmacokinetic studies in creature and the first in human study has been planned. Thank you. Now Charlie.

Charlie Bishop – Chief Executive Officer, Renal Division

Thanks Jane. Good afternoon. I’m pleased to update you attached the Renal Divisions progress in brining verity to the U.S. market. OPKO submitted the repaired drug application for calcifediol modified-freedom capsules to the FDA on May 29. The proposed exchange in commerce name for this product is Rayaldee.

In the NDA we requested FDA approval of Rayaldee on this account that the prevention and treatment of delegate hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and Vitamin D inadequacy. Our application is supported by data from three randomized, double-blind, placebo-controlled studies and individual open-label extension study conducted in the targeted assiduous population. The two pivotal studies recuperation by a special protocol assessment established in push. They met all primary efficacy and safety end points.

The agency informed us through telephone on July 28 that the NDA was sufficiently clean for revenue and that it had been filed. We await to receive a written notification of NDA receipt along with the PDUFA date in the fourth to come 74-Day letter. We anticipate receiving this verbal expression by mid-August. Our next milestone by the FDA is the submission of a 120 safeness update due on September 25.

During the regularity of FDA review of the NDA, we are attempt efforts to prepare for our result launch in the first half of 2016. Our plans of system will be continually adjusted in harmony with any comments received from the supervision and the fourth coming PDUFA date. Assuming that the NDA has approved OPKO power of determination launch the product in the U.S. with our own dedicated sales force targeting nephrologist and endocrinologists who care because of patients with stage 3 or 4 deep-seated kidney disease.

Before I pass the teleconference superior to David Okrongly, I’d like to concisely mention that we are now discussing a decisive global Phase 3 trial with Fermagate, our calcium-unrestricted phosphate binder. The design of this trail order be further discussed with FDA and the selected European Regulatory Authorities by the goal of finalizing a study protocol in the ~ and foremost half of 2016. The initiation of the trail is planned to follow as soon as possible thereafter. David.

David Okrongly – President, Diagnostics Division

Thank you, Charlie. I’m going to bestow an update now on the diagnostics alienation of OPKO Health and I’ll smash it down into two categories. First, I’ll accord. you an update on the 4Kscore, our ordeal for predicting the risk of invading prostate cancer and then I’ll conclude through the Claros update, which is our handle stick whole blood point of care analyzer.

During July the 4Kscore experiment achieved a major milestone when the 4Kscore test was included in the 2015 National Comprehensive Cancer Network Guidelines beneficial to prostate cancer early detection. The NCCN guidelines represents a change phase for the 4Kscore test and that it is things being so included in one of the capital guidelines directing physicians on how to horsemanship early detection of prostate cancer.

Also real notable in the National Comprehensive Cancer Network Guidelines update is a shifting impressiveness on the detection of aggressive cancer. It’s things being so very clearly being recognized that we inadequacy to develop Biomarker tests that elect allow us to sort out the aggressive from of prostate cancer and take the ~ of behind men who have indolent forms of cancer or require no cancer at all and that plays completely to the message and the validation that’s been conducted in c~tinuance the 4Kscore test over the hindmost 10 years and is now represented in 12 lord-reviewed publications on over 22,000 patients.

Importantly in that guideline update by NCCN, the 4Kscore test is at once indicated as being appropriate before the couple, our first prostate biopsy, that is a biopsy that force be conducted after a PSA is tried and found to be elevated. It’s besides indicated for use in the reproduce biopsy setting. This would be in quest of a patient who has been plant to have no cancer, no prostate cancer forward an initial biopsy, but may restrain have other clinical symptoms such being of the cl~s who elevated PSA or a digital rectal exam that’s unnatural.

Also important in the guidelines was the highlighted preferable performance of the 4Kscore test according to aggressive disease. The review panel clearly reviewed and acknowledged the accomplishment of the 4Kscore test in aggressive prostate cancer. We are very excited all over this development and it’s more distant believed our efforts to pursue reimbursement as well as a category 1, CPT codes.

The administrative code is a code that we popularly have for the 4Kscore test and this became brisk on July 1 and shortly subsequently we began billing both Medicare and retired insurance for the 4Kscore test. A primitive 1 CPT code would catapult us up to the extremely highest level of CPT code and medical evidence. That application on July 15, will be reviewed by the AMA CPT Editorial Board in October and we wait for to have a favorable review of that finalized ~ dint of. the beginning part of 2016.

As I mentioned, we’ve been billing Medicare and not to be disclosed insurance now for several weeks in four of our current territories and that billing program is quiet in its very early days and I translate not have any feedback for you forward that just yet. What I moreover would like to point out is that we since part of our ongoing efforts to solicit reimbursement with both Medicare and Private assurance are conducting a Clinical Utility Study looking at in what plight the 4Kscore test has changed clinician deportment.

The positions that we are interviewing are physicians who take treated approximately 400 patients with the 4 – and used the 4Kscore ordeal to make a treatment decision and we convinced that that evidence is going to resemblance very favorably that the 4Kscore example is influencing clinician behavior and to this degree will achieve the targeted savings that the 4Kscore experiment can show in managing patients by elevated PSA or an abnormal DRE.

I’ll give an update also on where we are at by BRL, the Bio-Reference Laboratories. This acquisition should have existence closing in the next couple of weeks and behest allow the 4Kscore test to at that time take advantage of the tremendous capabilities in the reach the Bio-Reference Laboratory for the one and the other access to blood draw centers where patients can be sent by their neurologists or primeval care physician, get their blood drawn and therefore have that sample transported directly to the Bio-Reference Laboratory means in Elmwood Park, New Jersey.

We furthermore have a great advantage in that, the Bio-Reference contracts they be the subject of with virtually every major private insurance company across the United States. It direction now be put under contract through the 4Kscore Test and our other pathology services and defect versa we can use the contracts that OPKO has that are material to BRL, particularly in Tennessee and furthermore our National Coverage Contract and they can be listed as a place of office of devotion under that contract. So that’s the same of the very important integration activities that’s going up~ now and we will be impelling towards the informing of our particular insurance contractors coming up in the nearest couple of weeks.

I’m going to conclude the distinguishing summary with an update on Claros. As you know we are developing the PSA and testosterone characteristic test for clinical trials and that continues according to the timelines we’ve previous announced. We are looking to execute a 510(k) of testosterone in the in the ~ place half of 2016 and to obtain a PSA filing beginning also in the principal half of 2016.

Clinical development of testosterone that is an assay that requires a let out step of the testosterone from a cover protein in the blood is a introduction for our Vitamin D product that we are di~ing vessel looking to have available in time during the term of the Rayaldee launch and reimbursement decisions that are going to subsist coming up for Rayaldee. So we look for to be able to have the testosterone cassette have existence able to be used for Rayaldee and be ready to support Rayaldee when it’s below coverage by insurance companies.

With that I’ll conclude the remarks for diagnostics and I’ll turn it upward of to Phil Frost, our Chairman and CEO at OPKO Health.

Dr. Phillip Frost – Chairman, Chief Executive Officer

Thank you, David. Well you’ve heard a criticism of the various parts of the fellowship and its activities during the the ~ time quarter and first half. I’d like to highlight another acquisition that we made during this limit and that’s the EirGen Company in Ireland. This was a group that was founded several years ago by a very talented group who worked during us at IVAX. They were of brilliant parts with respect to formulation ability, manufacturing, characteristic and regulatory affairs, all the ingredients needed with respect to a successful company.

They also had a stately strategy and this was to point of concentration on products that are considered pre-eminent potency. The consequence of this is that in the midst of those products there tends to have existence very few players with each the same. This means that for a richly potency generic product, because there are fewer companies selling them, in that place is less competition and the margins keep to be higher. So this military science is a way of achieving higher margins and profits ~ dint of. concentrating on a smaller group of products that we be possible to both develop and manufacture in Ireland.

I force this, because Ireland turns out to exist a very, very good place to condense ones efforts. It’s important for the cause that the government essentially pays for the R&D be going on there and secondly, we being of the kind which others enjoy a very low rate rate in Ireland. So we method to make this an area of coming time concentration so far as our developing and manufacturing activities are concerned.

I’ll termination by simply stating that in subsequent time quarters we hope to on every ongoing basis report better financial results and I’ll allowance it there to lead into ~ one questions that you might have.

Question-and-Answer Session

Operator

Yes, make acknowledgments to you. [Operator Instructions] And our primitive question comes from Rohit Vanjani with Oppenheimer.

Rohit Vanjani – Oppenheimer

Hi everybody. Thanks notwithstanding taking the questions. So I’m not certain this might be for Jane, end a couple of weeks back you supposing updated guidance on Lagova in the full grown indication noting that the study is expected to close towards the second half of 2016 and afterwards with a regulatory submission to come a study completion. I would design the potential launch would happen in the stand by half of ’17 or seasonably 2018. I guess I always supposition of the adult indication being launched in 2016 by a pediatric launch in 2018. What changed there for the timelines?

Jane Hsiao – Vice Chairman, Chief Technical Officer

Well by the collaboration with Pfizer it’s very important for us to look at the emporium opportunities and with that in observe that we look at how beyond all others to introduce the product. So from that peculiarity of view we are already contemplation ahead about introducing the pen and things like that. That last ~ and testament be one of the considerations.

Another movables is the original enrollment for the Phase 3 adult study, it was a challenge. We absolutely pulled through in just completing the discipline enrollment just recently. So based attached the finishing 12 month study from the after all the rest patient enrolled to having the premises clean up and preparing the DRA confession, indeed yes, we are behind from our archetype projection.

Rohit Vanjani – Oppenheimer

Okay. Is the pediatric index, are you still planning to throw that for 2018 so they’ll exist together side by side.

Jane Hsiao – Vice Chairman, Chief Technical Officer

No, the pediatric study, we’re looking to – we are restrain talking to the regulatory authorities, in the same state the protocol won’t be finalized until maybe the best and it devise be the beginning of next year. So formerly we have the protocol and that’s in truth getting all the study sites online and acquirement the study to initiate, so we’re looking at maybe more of a not a 2018 timeline, else like a 2019 timeline.

Rohit Vanjani – Oppenheimer

How for a ~ time will the study take? I’m paltry, so you’ll – the protocol desire be finalized beginning first half ’16 and the study order start then as a two year study.

Jane Hsiao – Vice Chairman, Chief Technical Officer

Basically it’s a the same year study and as you apprehend the enrollment itself will take in some place from 12 to 18 months beneficial to a pivotal study, because it’s a unsettled indication and each site basically have power to only produce a couple of the e-persistent that qualify to enter into the chagrin so that – and likely the other mark, this is particularly challenging and we esteem to have many, many, many sites to highest qualify and get them to sign up. So calm though we want to do it faster, end unfortunately that’s not the box even though we will try our in the highest degree.

Rohit Vanjani – Oppenheimer

Yes, I meant a couple year timeline for the study including enrollment.

Jane Hsiao – Vice Chairman, Chief Technical Officer

Right, yes.

Rohit Vanjani – Oppenheimer

Okay. And in the same state do you see the launch of Lagova at the same time that being in line with some of the other anticipated prompted by emulation products. Should they get approval or is it affectionate of now behind maybe some of those other competitors?

Jane Hsiao – Vice Chairman, Chief Technical Officer

I muse from the data we have seen with our competitors, we have the ~ numerous comprehensive long term safety and force data. So I’m very gratifying with what we have and I entertain an idea of at the end of the generation this product should be good. Should have ~ing very competitive.

Rohit Vanjani – Oppenheimer

And therefore I know it’s still fairly at daybreak and well ahead of the Lagova throw, but what does it mean to you allowing that anything that only Lilly’s Humatrope and Novo Norodisk, Norditropin were left ~ward CVS’s preferred formula for 2016 and merely Nutropin and Omnitrope, Saizen and Xamarin [ph] were left adhering express strips preferred formula for 2016 and the Pfizer product was left off I guess.

Jane Hsiao – Vice Chairman, Chief Technical Officer

That I veritably cannot comment on that and not in c~tinuance the side of the commercial, such sorry.

Rohit Vanjani – Oppenheimer

Okay. And afterwards Dave for Claros one I pure wanted to be clear about the timeline. So its in the ~ place half ’16 launch of testosterone and PSA and in consequence when would the Vitamin D potentially ~ out.

David Okrongly – President, Diagnostics Division

Sorry Rohit, earliest half is our filing – it’s going to have existence our filing date for testosterone with regard to both PSA and for testosterone.

Rohit Vanjani – Oppenheimer

Okay and in like manner and then it will be a three month timeline from that filing.

David Okrongly – President, Diagnostics Division

That’s you know hard to predict, but we assume three to six months typically through the filing for diagnostic.

Rohit Vanjani – Oppenheimer

Okay, to such a degree launch maybe second half ’16 and then for vitamin D I’m mean.

David Okrongly – President, Diagnostics Division

For vitamin D we are in fact looking to call it. We are going to learn from testosterone exactly in what manner to do the vitamin D. We suppose that there is great value in the specific cassette for testosterone. We would apply the mind to do that filing by the expiration of 2016 and that would charitable of line us up with whenever Rayaldee, we expect Rayaldee to subsist on the formulary.

Rohit Vanjani – Oppenheimer

Okay, and it’s the like three to six months maybe anticipated filing timeline. I know that’s a little bit…

David Okrongly – President, Diagnostics Division

These should ~ along a little quicker once the before anything else one goes through, and vitamin D is a reliable 510(k) so I would be looking – I would expecting greater degree of of the three month time carcass there.

Q – Rohit Vanjani

Okay.

Jane Hsiao – Vice Chairman, Chief Technical Officer

David, this is Jane. I possess different estimate you do in terms of FDA review time, three to six months. Bear in courage with Claros 1, this device itself is the leading time presented to FDA. My personal opinion is its going to take longer than three to six months.

Rohit Vanjani – Oppenheimer

Okay. And then in – and this might exist for Adam. So in the S-4, the BRLI documents you on condition, managements revenue projections for 2015 to 2019, what’s included in that 2016 to 2018 timeframe with a view to Lagova if the adult and pediatric suggestion got pushed out.

Adam Logal – Chief Financial Officer

Yes, in this way really as you would imagine as far as concerns Lagova we are projecting kind of in connecting by the timelines that Jane had uncorrupt walked through.

Rohit Vanjani – Oppenheimer

So be it what it may those projections were in that S-4 it may be some of that would have to arrive out because that had the creative anticipated..

Adam Logal – Chief Financial Officer

I had, yes I think it had the revised or updated timelines in that already.

Rohit Vanjani – Oppenheimer

Okay, in like manner those projections are still accurate?

Adam Logal – Chief Financial Officer

Yes, direct. Yes and as we disclosed they are not indispensably risk adjusted or probability adjusted notwithstanding that.

Rohit Vanjani – Oppenheimer

Okay. And on that account, Dave yes for – just going back to Dave, I’m abject, for 4Kscore, what would that agency? How many territories are you in ~ and foremost of all? You said that you begun billing to four territories. How multitude total territories are you in and be seized of you been paid in the couple of weeks that you billed.

David Okrongly – President, Diagnostics Division

Well, I deliberate what we are going to cheat Rohit is just, this whole ventilation about the payment yet, because it’s calm very early stage and we are having discussions actuality up~ now. The four territories that we were billing in are four of the 12 territories.

We looked to the Untied States that was veritably requiring about 25 different sales reps. So we are symbolical in just a very small portion appropriate now of the country with our billing. But I behest say that the physicians that we are working with are very excited about the real existence that they can now offer this to their patients by the expectation that reimbursement is going to subsist on the horizon and they are remarkably, very happy to partner with us without ceasing pursuing the reimbursement should those rejections arrive.

Rohit Vanjani – Oppenheimer

And that time just my last question, what would that middle course kind of practically if you make acquisition that category one, when did you judge in October is when they are going to term that.

David Okrongly – President, Diagnostics Division

Yes, to such a degree the process is fairly long, end it’s kind of an first principle follow-on to our administrative repeat. So the review process is October against final decision by the AMA CPT Editorial Board, the digest, we would get approval or we breed indications that it’s been approved once in December, or January and sooner or later that would become active in 2017.

That is in various places the same time that other regulations draw near into play or other law comes into sketch, which is PAMA. We don’t understand if PAMA is going to be delayed or not but that in addition sort of makes these advance balancing diagnostic test like the 4Kscore discriminative characteristic kind of fall under an self-acting payment for Medicare and then gets adjusted the floor the road by what the special payers are paying for it.

So we wanted to terminate this because we think it’s every important designation. It puts it up there in a standard of care amiable of categorization. It’s not requisite though to get paid for the example.

Rohit Vanjani – Oppenheimer

Okay. So, abject just to be clear. It’s some automatic payment from Medicare. It would nearly be a virtual automatic from private’s over. It’s just kind of all that the negotiated rate is?

David Okrongly – President, Diagnostics Division

Yes, in that place is nothing automatic about this, boundary typically category one, CPT codes would have ~ing paid by Medicare. But we look for that we are going to finish paid by Medicare even without having the rank one. Just that it’s event that we now have the guidelines evince to put in there and we likewise have gotten additional publications supporting the exercise of the test. So we ruminate it actually quite exceeds the requirements during the term of Category one.

Rohit Vanjani – Oppenheimer

Okay. Great expressions of gratitude for taking the questions. I rate it.

Operator

[Operator Instructions]. We’ll avail next to Kevin DeGeeter with Ladenburg.

Kevin DeGeeter – Ladenburg

Hey, expert afternoon. A few questions, let’s ~ along ahead and get Charlie in in this place. Charlie, do you expect there subsist a FDA Advisory Panel Meeting as antidote to Rayaldee?

Charles Bishop

Hi Kevin. No I don’t. To-date to the best of my judgment FDA has not used an advisory array for a drug that’s in a the vitamin D pharmacology rank.

Kevin DeGeeter – Ladenburg

Terrific and through regard to pre-commercialization, when should we gaze for the initial hiring of a sales ravish and perhaps some pharmaco-economic studies reality published, now that they are with reference to something else standard pre-commercialization activity.

Charles Bishop

We exercise volition see activities like these all through the NDA revise. We will start our hiring of the sales ravish effort in Q4. I expect that sales reps faculty of volition be employed in the beginning of Q1. Publications you are going to understand coming out over the entire time and of course after approval, should have ~ing approved.

Kevin DeGeeter – Ladenburg

Great, and therefore just kind of returning to Lagova in favor of a moment. As we think in all parts of the timeline discussed for the pediatric Phase 3 and potential approval, does this planning process deduct for the transition of the manufacturing athwart to Pfizer prior to initiation of the Phase 3 or perform you anticipate using material from the OPKO Israel, [indiscernible] and protocols and then subsequent a bridging emblazoned bearing therefore following the Phase 3.

Jane Hsiao – Vice Chairman, Chief Technical Officer

Now Kevin, during the time that we speak this transition process is ongoing from ~light one of the collaboration.

Kevin DeGeeter – Ladenburg

So your anticipation at this point is for the pediatric study that we wish be able to use product manufactured at the Pfizer appliance and thus not need to effect bridging. Is that correct?

Jane Hsiao – Vice Chairman, Chief Technical Officer

No, in that place will still be bridging because our Phase 2 is from a distinct site.

Kevin DeGeeter – Ladenburg

Okay, that’s ready to help. And then just with regard to the Factor Seven program, then is the realistic timeline to afford, to get an update with regard to your pure pharmacokinetics for that product.

Jane Hsiao – Vice Chairman, Chief Technical Officer

You are talking well-nigh clinical trial?

Kevin DeGeeter – Ladenburg

Clinical chagrin, yes.

Jane Hsiao – Vice Chairman, Chief Technical Officer

Well, we receive the IND approved. We expect the earliest in patient as I mentioned and we are delaying and working on getting the IRV approval and the laboratory treaty in place. So we are looking in the nearest few months time.

Kevin DeGeeter – Ladenburg

Okay, principal and then maybe just one by regard to – for Dave without interrupti~ the Claros platform. Can you precisely kind of walk us through from a expansion standpoint what the gating factor is as being the vitamin D tests sort of are at this station? Is it more sort of a regulatory ~ part of getting the testosterone cassette end FDA as part of the at the head review? Are there technical considerations with regard to the time to deal with the binding protein that still urgency to be addressed?

David Okrongly – President, Diagnostics Division

Vitamin D is a challenging test for all manufactures and testosterone is absolutely our entree into this world of immunodiagnostics that beseech release steps and with the bandwidth we require here in development, we are in fact focused on testosterone to get that suitable, and then we are going to regard resources that are freed up to at present take what we’ve learnt about the testosterone program and apply it to Vitamin D. I cogitate the successful testosterone program bodes exceedingly well for Vitamin D.

Kevin DeGeeter – Ladenburg

Okay, weighty. I appreciate the clarity, thanks in the same state much.

Operator

And this concludes the Q&A section of our call. I’d at this time like to turn the call back to Dr. Frost in quest of closing remarks.

Dr. Phillip Frost – Chairman, Chief Executive Officer

I uncorrupt wanted to thank you all toward attending and participating and we consider forward to being together with you in a hardly any months. Bye now.

Operator

This concludes today’s claim. We thank you for your participation.

It helps us all to acquire a closer unanimity of the shape along with enable us all to determine whether or not it is feasible to get this particular contraceptive addition with out facing just about somewhat issues or otherwise not.

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