Executives
Mike Aguiar – SVP and CFO
Rick Winningham – CEO
Analysts
Steve Byrne – BofA Merrill Lynch
David Friedman – Morgan Stanley
Anant Padmanabhan – Cowen and Company
Brian Skorney – Robert W. Baird & Company, Inc.
Howard Liang – Leerink Swann & Company
Theravance Inc (THRX) Q3 2013 Earnings Conference Call October 24, 2013 8:00 AM ET
Operator
Ladies and gentlemen, good afternoon. At this time, I’d like to welcome everyone to the Theravance conference call to review results for the quarter ended September 30, 2013. (Operator Instructions).
I would like to turn the call over to Mike Aguiar, Senior Vice President and Chief Financial Officer. Please go ahead, sir.
Mike Aguiar
Good afternoon everyone and thank you for joining us. With me on the call today is Rick Winningham, our Chief Executive Officer.
First Rick will review highlights of the quarter and then I’ll review the financial results. Following our comments, we’ll open the call for questions.
Earlier today, Theravance released a press release detailing third quarter 2013finance results and recent corporate developments. A copy of the press release can be downloaded from our website or you can call Investor Relations at 650-808-4100 and we will be happy to assist you.
Before we start, we would like to remind you that this conference call contains forward-looking statements regarding future events and the future performance of Theravance. Forward-looking statements include anticipated results and other statements regarding Theravance’s goals, expectations, strategies, and beliefs.
These statements are based upon the information available to the company today, and Theravance has no obligation to update these statements as circumstance change. Future events and actual results could differ materially from those projected in the company’s forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the Company’s Form 10-Q filed with the SEC.
I’ll turn the call over to Rick Winningham our Chief Executive Officer. Rick?
Rick Winningham
Thanks, Mike. Good afternoon everyone.
Since our last call in July, Theravance has had terrific progress and momentum across its portfolio. In particular, we are pleased with the progress of the respiratory programs, including the approval in Japan of RELVAR ELLIPTA for asthma, regulatory recommendations for marketing authorizations for RELVAR ELLIPTA and ANORO ELLIPTA, some positive phase II B study results for TD-4208.
In addition, we continue to work on activities related to the separation of the late-stage respiratory assets partnered with GSK from a biopharmaceutical operations to create two independent publicly traded companies. We are also pleased that GSK recently began shipping BREO ELLIPTA in the US.
Let me begin with the plan separation. The Company’s plan is create two highly focused businesses with unique strategies and risk profiles that have the potential to increase overall shareholder value. The separation is designed to provide investors the opportunity to unlock potential value from the two different sets of assets to facilitate return of capital to stockholders and further our strategy of advancing medicines that address unmet medical need.
As a reminder, one company, Theravance a royalty management company, which we will refer to as Royalty Management Company in the call, will continue to manage all development commercialization responsibilities under the two GSK agreements and is eligible for potential near-term royalty revenues from RELVAR or BREO ELLIPTA and ANOR ELLIPTA, as well Elantro [ph] monotherapy. Royalty Management Company will focus on returning capital to stockholders
The other company, Theravance Biopharma, which we will refer to as Theravance Biopharma, will have the on the capabilities of Theravance today and we’ll focus on discovery, development, and commercialization of small molecule medicines by exploiting insights created by our extensive experience in multivalent drug design.
The result will be two independent publicly traded companies with different business models, again, enabling investors to align our investment philosophies with strategic opportunities and financial objectives of the two independent entities. A form 10 for Theravance Biopharma has been filed with the SEC. We are dedicating significant effort towards the successful completion of the separation. We are still on track and expect to complete the separation either late this year or early 2014.
Turning now to the respiratory programs partnered with GSK.
GSK and Theravance are developing an important portfolio of inhaled medicines for the treatment of both Asthma and COPD. Our pipeline includes single mechanism, duel mechanism and triple mechanism therapy, all delivered by a common inhaler. The portfolio has the potential to be the most comprehensive in the industry targeting a wide range of patients with COPD and asthma, who have different needs and different severities of disease. The respiratory portfolio has progressed significantly – and within the portfolio, most significantly, BREO ELLIPTA, RELVAR ELLIPTA, and ANORO ELLIPTA.
First, let’s discuss BREO or RELVAR. A dual mechanism medicine that combines an inhaled corticosteroid with [INDISCERNIBLE] of FF in the long-acting beta agonist, vilanterol, or VI, administered by new dry power inhaler called ELLIPTA. BREO ELLIPTA is approved by the FDA for patients with COPD. It’s first – once daily inhaled ICS LABA combination for the treatment of COPD that delivers continuous 24 hours efficacy.
As was noted yesterday, GSK recently began shipping BREO ELLIPTA to the US wholesalers. This is an important milestone for Theravance and for doctors and patients dealing with this debilitating disease.
BREO ELLIPTA was also approved for the treatment of COPD by Health Canada in July under the same trade name. In September, RELVAR ELLIPTA was approved in Japan for the treatment of bronchial asthma, the first approval in this indication. The approval of RELVAR ELLIPTA will provide Japanese physicians with the new, important, once daily inhaled treatment option for their asthma patients that delivered continuous 24-hour efficacy.
Another important milestone accomplished in September was the positive opinion issued but the European Medicines Agency Committee for medicinal products for the human use recommending marketing authorization for FFDI under the proposed brand name RELVAR ELLIPTA for asthma and COPD. We look forward to the full-time decision by the European commission potentially during the fourth quarter of this year.
During the third quarter, the third phase III head-to-head study of RELVAR BREO ELLIPTA 100 micrograms of FF combined with 25 micrograms of VI and Advair discus, 250 micrograms of fluticasone furoate combined 50 micrograms with some meterol [ph] has been completed. In this study, RELVAR BREO demonstrated numerically but not statistically significantly improvement in long functional over Advair.
This is consistent with the results from one of two previous studies, which were announced in March 2012. This study adds relevant information to the totality of data available for the medicine that RELVAR BREO provides effective broncho dilation in patients with COPD, and we intend to publish in the near future. RELVAR BREO is an important once-daily ICS LAB treatment option for doctors and patients again dealing with COPD.
Turning now to our second respiratory program with GSK, ANORO ELLIPTA, which is a dual mechanism investigational medicine for the treatment of COPD that combines two bronchodilators – a long-acting muscarinic antagonist, umeclidinium bromide, or UMEC, and a long-acting beta-2 agonist, VI. ANORO ELLIPTA is the proposed proprietary name for this LAMA/LABA combination of UMEC/VI.
We are pleased to report that in September, the advisory committee to the FDA recommended approval of UMEC/VI at a dose of 62.5 micrograms of umeclidinium and 25 micrograms of vilanterol for the treatment of COPD.
But the date for UMEC/VI is December 18. Regulatory filings are currently under review in the US, Europe, and Japan and regulatory applications have been submitted in a number of other countries worldwide.
The respiratory markets we are targeting with our GSK collaboration represent a very significant commercial opportunity. In 2012, reported sales of twice a day medicines containing a long-acting beta agonist, combined with inhaled corticosteroid totaled $11 billion worldwide. In addition, global sales of spiriva, a muscarinic antagonist were approximately $4.5 billion in 2012.
Looking forward. We expect this market to continue to grow due to increasing diagnosis of COPD, additional therapeutic options and more convenient dosing regimens. According to IMS data, 50% of current sales of products containing long-acting bronchodilators are outside the United States and about half are inside the United States, again, where we recently began shipment of BREO ELLIPTA.
As a reminder, Theravance is entitled to receive 15% royalty on the first $3 billion of global net sales and 5% thereafter on an annual basis for either BREO or RELVAR ELLIPTA. For ANORO ELLIPTA, we are entitled to receive royalties on global net sales upward tiering for the mid-single digits to 10%.
GSK and Theravance also have a goal of combining three mechanisms in a single inhaler, which may be important for the patients with severe COPD and asthma, as highlighted in recent scientific conferences. In addition, the global initiative for chronic obstructive lung disease or gold guidelines support the use of triple therapy, as first choice in patients that are symptomatic with a higher risk of exacerbations. This is an important potential market in the United States and globally and was noted by Andrew Witty yesterday in the GSK quarterly call as the triple therapy effort.
This effort is combined – comprised of two programs; ANORO plus FF, which I will refer to as the closed triple, and MABA plus FF in a single inhaler. GSK has completed the first of two phase I settings of the investigation combination medicine UMEC/VI and FF administered in the ELLIPTA dry powder inhaler. The study was designed to evaluate the systemic pharmacokinetics systemic pharmacodynamics and safety and tolerability of a new triple fixed dose combination investigational product. After the phase I program is complete, we’ll update you on the next phase. We’re encouraged, we’re optimistic in the ANORO royalty rates applied to the close triple.
In our model program partnered with GSK, Theravance announced in July that GSK initiated preclinical phase III enabling studies and the combination of ‘081/FF program and at the phase III study of ‘081 monotherapy would not be initiated in 2013. This was the result of GSK’s decision to move away from the twice-daily program using discus as the inhaler and fluticasone furoate of FF as the steroid to a once-a-day program with ELLIPTA and FF as the steroid.
This move requires additional work such as nonclinical studies, manufacturing, and phase I bioequivalent study. GSK and Theravance are in further discussions regarding the model program in respective timing but Theravance believes it’s unlikely that a phase III study with ‘081 will commence in 2014.
However, both companies remain excited about the MABA program, as well as MABA plus FF. The eventual royalties on MABA that Theravance will be entitled to receive will be 10% to 20% royalties on a global net sales basis up to $3.5 billion and 7.5% thereafter. If ‘081 has commercialized the combination product, such as ‘081/FF, the royalty rate on the combination is 70% of the single agent.
Importantly in addition to these respiratory programs partnered with GSK, Theravance is developing TD-4208, an internally discovered multivalent long-acting muscarinic antagonist or LAMA delivered once a day in a nebulizer for COPD. The current goal of our LAMA program is to develop a once-a-day inhaled medicine in a nebulizer that offers improved efficacy and tolerability relative to current therapies and it provides a basis for combination nebulized products with other medicines, such as an inhaled corticosteroid. We have high expectations for the program.
This past quarter, we reported positive top line results from the phase II B study of 4208, which evaluate the safety and efficacy of multiple doses of the product in an aqueous nebulizer. In summary, all doses in the phase II B program met all primary and secondary end points providing significant and clinically meaningful bronchodilation at higher doses.
The 24-hour serial FEV-1profiles are consistent with a once-daily regimen. The safety and tolerability of 4208 appeared comparable to placebo at the dose of study. We look forward to continued analysis and we are planning next steps with this program. We believe the opportunity for a nebulized product is significant and complementary to that addressed by the GSK Theravance collaboration products.
Turning now to our bacterial infections program, VIBATIV, is a bactericidal once-daily injectable lipoglycopeptide antibiotic approved in the US for treatment of adult patients with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates and Staph aureous when alternative treatments are not suitable, as well as indicated for adult patients with complicated skin and skin structure infections caused by susceptible gram-positive bacteria, including Staph aureous; both [INDISCERNIBLE] susceptible strains.
In August 2013, Theravance commenced shipments of VIBATIV into the US whole sailor channel. We’re pleased that Theravance has reestablished reliable product supply and brought VIBATIV back to the US market, as it is an important treatment option for physicians and patients dealing with MRSA infections. Hospital-acquired pneumonia is a serious disease and one associated with one of the highest mortality rates among hospital-acquired infections and increases in hospital stay as well as costs of care. MRSA pneumonia in particularly is an increasingly challenging infection, as there are few approved treatments available today and reduced susceptibility to existing therapies remain a problem.
The lead compound in our norepinephrine and serotonin reuptake inhibitor program for the treatment of central nervous system conditions, such as chronic pain and Attention-Deficit/Hyperactivity Disorder. TD-9855 is being evaluated in an ongoing phase II safety and efficacy study in adults with ADHD and in another separate phase II study in patients with fibromyalgia. We believe that there is significant opportunity in fibromyalgia for more efficacious treatments and in ADHD for an efficacious treatment without the risk of abuse associated with stimulants. We’ve completed enrollment in the phase II study in ADHD with results expected to be reported shortly while the results of the phase II study in fibromyalgia are expected during the first half of 2014.
In closing the business update, TD-5108, a 5-HT4 agonist is finishing up a phase II study in gastroparesis and we will be initiating another phase II study with TD-8954 and IV 5-HT4 agonist in the neoropeding [ph] and tolerance.
I’ll now turn the conference call over to Mike Aguiar, our Chief Financial Officer. Mike?
Mike Aguiar
Thanks, Rick.
Today, I will discuss results of the quarter ended September 30, 2013, and will review guidance for the full year 2013 and expenses.
For the quarter ended September 30, 2013, Theravance had a net loss of $47 million or $0.44 per diluted share. Revenue totaled $400,000 during the third quarter of 2013, compared with $1.4 million for the same period in 2012, a decrease of $1 million.
For the first nine months of 2013, revenue was $3.1 million, compared with $130 million for the same period last year. The decrease in the first nine months of 2013, relative to last year, was primarily due to the termination of our VIBATIV agreement with Astellas last January that resulted in a one-time recognition of $125.8 million of deferred revenue.
As announced in August, Theravance reintroduced VIBATIV into the US market during the third quarter. All VIBATIV revenues have been recognized as deferred revenue on the balance sheet at this time in order to generate additional sales and rebate data needed to finalize how our VIBATIV revenue accounting policy.
Total R&D expenses for the third quarter of 2013 were $33.4 million, compared to $27 million for the same period last year. This increase was primarily due to higher external costs related to three phase II clinical studies, including two with TD-9855 – one in fibromyalgia and one in ADHD – and a recently completed phase II B study of TD-4208 since COPD. In addition to these clinical costs, we also had higher expenses associated with our preclinical and late-stage discovery programs.
Selling, general, and administrative expenses for the third quarter of 2013 were $12.3 million, compared to $7.8 million for the same period in 2012. The majority of the increase was due to higher legal and accounting costs related to the Company’s planned separation.
Total external expenses included in SG&A related to the pro company separation were $3.9 million for the quarter and $6.2 million for the first nine months ended September 30, 2013. Cash, cash equivalents, and marketable securities totaled $594.5 million as of the end of the quarter, an increase of approximately $61.2 million.
This increase was primarily due to net proceeds of $111.9 million received from the Company’s private placement of common stock to an affiliate of GSK partially offset by$10 million milestone payment to GSK for the Japanese approval of RELVAR ELLIPTA and to Q3 operating expenses. The sale of share to GSK was a result of GSK’s exercise of its right to maintain the percentage ownership of Theravance triggered by the conversion of outstanding convertible notes.
Now turning to our guidance for 2013.
In order to provide comparability for our prior financial guidance metrics, we have identified and excluded all costs associated with our separation activities from our expense guidance. For full year 2013, we are keeping our non-GAAP in the range $125 million to $130 million but will likely be at the upper end of the range.
As a reminder, our guidance includes total R&D and total G&A expenses but includes stock-based compensation expense, any potential milestone payments under the LABA collaboration and costs associated with the separation of the Company.
Now I’ll turn the call back to Rick for final closing comments.
Rick Winningham
Thanks, Mike.
As I mentioned earlier, it’s been a remarkable year to date for Theravance and importantly we have a number of catalysts before the end of the year. These include the potential approval of RELVAR ELLIPTA in the EU, the potential approval of ANORO ELLIPTA in the U.S. and the results from the TD-9855 phase II study on ADHD.
In 2013, we have the potential to receive three regulatory approvals in the US. We’ve already received VIBATIV approval for hospital-acquired pneumonia and ventilator-associated pneumonia. We already received approval for BREO ELLIPTA for COPD. We are anticipating, based on a positive advisory committee in September, the potential for an approval of ANORO for COPD on December 18th. Over the years, Theravance’s expertise in multivalent drug discovery has developed a small molecule robust product pipeline with promising potential medicines in a number of different therapeutic areas.
Looking forward I’m very excited by the clinical and regulatory events as well as significant opportunities associated with our separation into two companies later this year or early in 2014. Our management team and Board are enthusiastic about the future of Royalty Management Company and Theravance Biopharma.
And now, I’d like to turn the call over to the conference facilitator and open the call for questions.
Question-and-Answer Session
Operator
Thank you, Sir. (Operator Instructions) And we’ll pause for a moment to assemble our roster.
Okay. We’ll have our first question is from Steve Byrne with BofA Merrill Lynch. Steve, please go ahead.
Steve Byrne – BofA Merrill Lynch
Yes, thank you.
There was another phase III study posted on clin trials recently that looks like UMEC being added onto patients being treated with BREO. Is that two different devices? Or is that in some way the closed triple?
Rick Winningham
Hi, Steve. This is Rick. I’ll start and let Mike comment.
Yes. That’s – that is what I would call “open triple”. It’s a combination of BREO plus umeclidinium, both in two different devices. Clearly, you – in my comments both GSK and Theravance believe there’s a significant opportunity for triple therapy. And our objective is to have the triple therapy in a single inhaler. And until then of course, we can work with GSK to develop information on the combination in two separate inhalers. Mike?
Mike Aguiar
Yes, Rick. I think you hit upon the big points here. Again, this is a substantial market opportunity. And we had announced a period of time ago that we were having multiple approaches towards triple. So there’s – you know this approach which again is what we’ve loosely called the open triple, which are two devices; there’s the closed triple which had all three of the active ingredients out of either RELVAR or ANORO and then there’s the potential for MABA plus FF. So, there’s three separate paths towards triple therapy here. This is awfully important to us. So –and that’s what I would interpret that study as related to – rather the – in the closed triple.
You won’t notice there are a number of studies out there. And I think we do our best to talk about the really relevant ones that are kind of coming up and decision making. But I would just there are a number of studies that are going on. This is a very, very big robust program that GSK and Theravance are doing. So, again, there will be, you know, various phase III and phase III B studies you’ll see out there. And you always have to talk about them, as they come up.
Steve Byrne – BofA Merrill Lynch
And in your view how does the addressable patient population differ between ANORO and MABA? And is there enough differentiation there to warn – to moving ahead with the phase III in MABA?
Rick Winningham
Sure, Steve. Well, I think, the addressable patient population that can benefit from therapy from the activities of a muscarinic antagonist and beta II agonist, that’s patient pool is quite significant.
We know what the profile is of ANORO and phase III studies. We haven’t taken MABA to phase III. But I think the phase II data is presented at ERS some time ago gives us some reason to be hopeful on potential areas of differentiation.
In addition to single agent MABA, I would say very importantly is it would be the product that includes at least initially, fluticasone furoate, giving us an opportunity for the – you know closed triple therapy, except that it would be close triple therapy through the development of only two medicines. That could certainly be a very important product, given the size of potential triple therapy market that we see in the future both in COPD and potentially asthma.
So I think MABA is a foundation. I really view it as a foundation-like product, where other products can be added to that over time. The first one of course being FF.
I’ll now tie that briefly into the importance of the development of Theravance of our own long-acting muscarinic antagonist 4208. I view 4208 sort of in much the same way. Although just a single mechanism. And that it could serve for other combination products to provide utility, and particularly in a nebulizer to patient populations most obviously in COPD, but potentially in asthma, give recent data that’s been presented at both chest and ERS.
Steve Byrne – BofA Merrill Lynch
And any particular gating events that are holding up moving the MABA into the Phase III program?
Rick Winningham
Well, I think the primary gaining event has now been the move from the discus to the ELLIPTA device. You know we had been developing – GSK had been developing MABA in the discus. They have now moved to the ELLIPTA.
I think longer term, that’s very important for the franchise because that will mean that all of the products will have a common device being the ELLIPTA. But the switch from the discus to ELLIPTA has resulted in a bit of a delay for MABA.
Steve Byrne – BofA Merrill Lynch
And then just one on the separation, have you come to a decision on if you’re going to try to move the biopharma IP to an offshore jurisdiction and where that might be.?
Mike Aguiar
Steve, that’s the intention as of today. We’ve made a significant amount of progress down this path. It’s not done until it’s done. But I think we’re continuing to be optimistic about the potential to re-domicile the biopharma business.
If you were to pull the form 10, which is on file, you’ll see it domicile in the Cayman Islands. That’s where it is currently. Certainly that’s a you know, very, solid corporate place to be from an overall legal perspective and all of that. So, I think we feel pretty comfortable today with that.
I would just say with regard to final decisions, stay tuned. We have some more work to do with the IRS and SEC to finalize everything. But at least as of today, I think, we remain optimistic about this.
Steve Byrne – BofA Merrill Lynch
Thank you.
Operator
Okay, thank you. And we’ll have our next question is David Friedman from Morgan Stanley. So, David, please go ahead.
David Friedman – Morgan Stanley
Hi. Thanks for taking the question. I just wanted to clarify for the ANORO-based triple, I think you said the royalty rate is the same as ANORO. And so, I just wanted to confirm that was the case and whether that would – if there’s anything available in that depending on, you know, how the triple were to be priced, given that the vilanterol potentially a smaller part of the triple, in terms of the one of three drugs instead of one of two.
Mike Aguiar
Yes. Thanks for the question, David. So, the royalties are the same exact tear for the triple as they would be for ANORO, and both royalties are based upon the total selling price of the product, not some pro rata portion of the selling price that would be allocated each of the compounds. So, we have not clearly made final pricing decisions on what a triple would be or ANORO would be.
But, you know, you would suspect that they potentially could have different price points. You know so at the end of the day, it’s simply whatever the per unit price is times the relevant royalty tiers and that will be the economics that below the Theravance.
You know I just – I would echo something Rick said a little bit ago and I think that I mentioned also which is the opportunity for the triples – if we are ultimately successful – is really quite interesting. And so we are a little bit earlier than that than we are with ANORO or RELVAR. But these have the potential – should the clinical data and sort of the medical data is being developed out there continue to look good.
David Friedman – Morgan Stanley
Thanks. And then just a quick follow-up on the re-domicile question. Is this – have you guys made moves to re-domicile all your IP in the Cayman Islands as well? And does that include the IP for the MABA? Or does the MABA IP stay what you have to stay?
Mike Aguiar
Yes. It’s a fairly complex question, and I’m not sure I would want too into the whole detail of it right now. There’s a lot of detail in the form 10.
But, you know, we’re intending if successful with the re-domiciling effort to have the Company be a Cayman-based and, as a result, everything would be, at that point, not in the US jurisdiction from the top level.
As you start to get to things like the royalties related to MABA and the closed triple in there, that’s a slightly different story. We don’t have rights to those that are being transferred to biopharma, it’s just economic rights.
And so that’s why I mentioned earlier it’s a complex question and there’s no IP related to those that’s going over. Biopharma just purely has economic rights related to that. So, again, it’s a much more complex question probably we can get into the call but you want to take a look at the form 10, that’d be great or, again, I’d be happy to take a little more time with you on a separate point and kind of go through it.
David Friedman – Morgan Stanley
Thanks. We’ll take a look. Thanks.
Mike Aguiar
Yes.
Operator
Okay, thank you. And we’ll have our next question from Anant Padmanabhan from Cowen and Company. Anant, please go ahead.
Anant Padmanabhan – Cowen and Company
Yes, thanks. Just a couple of questions.
One – could you update us on the asthma study for BREO. When might we see the data? And could you remind us of your conversations with the agency on this indication? And then I have a follow-up on the MABA.
Rick Winningham
Sure. So the asthma study for BREO, 900 patient study, relative short term in duration listed on clintrials.gov. Last patient, last visit is late this month. And I think we’ll get last patient, last visit. And at some point in time in the future whether late this year or early next year, I can’t provide any information on that. Certainly, the data will be available.
This is a critical component for us, for the overall asthma package in the United States. If you look at the doses that are in this phase III study, the doses have been studied in various patient populations in earlier phase III studies so you can get an idea of what the potential effect size would be.
But, you know, when we get the data and GSK has the data, we’ll get – we’ll agree with them on a path forward for making the data public.
Anant Padmanabhan – Cowen and Company
Okay, thanks. And…
Rick Winningham
You had a follow-up on MABA, I think.
Anant Padmanabhan – Cowen and Company
Yes, yes. So, is there any reason to expect that the efficacy or safety of the MABA would be different with ELLIPTA versus discus? Thanks.
Rick Winningham
I wouldn’t – you know I wouldn’t – I mean the efficacy and safety of the molecule know – not – there’s no reason per say that you would think it would be – I think we just need – we need to go through the, more or less, mechanical studies with the ELLIPTA to ensure that we got the same, you know, particle distribution so forth that we were able to achieve in the discus.
As I said, I think for the overall portfolio, this is an incredibly strong move to have the platform of products in a single dry powder inhaler. It will make it much easier for patients, much easier for physicians and much easier for the nurses or physicians assistants that are supporting the patients and understanding how to use the medicines because – that series of medicines because they will just have to learn how to use one inhaler type.
Importantly, as you look at, you know, sort of the entire suite of products, umeclidinium, the long-acting muscarinic antagonist, the single agent, now we don’t get any economics on umeclidinium but we actually believe it’s very important to have umeclidinium out in the market as a single agent with the ELLIPTA device because that will I think – based on everything we know from patient experience and physician experience, further solidify the comfort with the device by physicians, other healthcare professionals and patients.
Anant Padmanabhan – Cowen and Company
Great. Thank you.
Operator
Okay, thank you. And our next question coming from Brian Skorney from Robert W. Baird. Brian, please go ahead.
Brian Skorney – Robert W. Baird & Company, Inc.
Thanks for taking the question. I have a couple actually. I’ll defer to my respiratory questions and a couple of question and some other items.
Starting with OIC, I know there’s a FDA advisory panel that discuss some of the safety and trial design issues around these compounds. And you know, Rick, I know we’ve tackled a bit in the past about the FDA’s requests regarding TD-4011 and they differ a little bit from what some of the competitors’ view in terms of what the safety hurdles and regulatory hurdles are.
I’m just wondering if you guys comment – have you been invited to the panel? Do you anticipate attending the panel and being present at the panel? And you know kind of what are your thoughts regarding what you think are likely to be the outcomes or key discussions from the panel?
Rick Winningham
Yes. So, I think we’re talking with a number of different interested parties –regulators being one of them about the pane, l and where – or if our contribution would be valuable. I anticipate that the subject of the panel will likely focus on at least partially the number of patient exposures needed to satisfy the agency relative to ruling out, you know, any sort of negative cardiovascular effects. I mean this is, you know, a constant – had been a relatively constant theme. We – the rate of cardiovascular events of these patients are relatively small that because of the low event rate, the – may study design is – ends up being – adding significantly to the overall phase III design. And I think that’s likely to the discussion points at the panel.
Whether we participate, we haven’t made a decision yet. But we’re certainly very interested in the outcome. You know we continue to work on the background of 1211, you know, while we’re not – we haven’t entered the phase III. We’re certainly doing everything we can should we make a decision to go forward probably with a partner in the phase III that everything else is sort of net debt for the program.
So, I just say stay tuned and we’re looking forward to continuing our discussions and heading towards the March advisory committee.
Brian Skorney – Robert W. Baird & Company, Inc.
Great. And then just – I could ask the question on VIBATIV. Now, that you’re back in the wholesaler channel and in [INDISCERNIBLE] pneumonia, you know it seems that there’s – use of VIBATIV would probably be, in many cases, scenarios where the other options or patients [INDISCERNIBLE]. I just wondered if you have any thoughts on repricing VIBATIV that sort of premium in mind. Obviously, oncology drugs that have very little bifurcation but our price are very, very high premiums. Would you anticipate doing that yourselves? Or do you think that’s more of a discussion to have with a partner?
Mike Aguiar
So, yes, obviously that’s the topic and certainly there’s a big difference between, let’s say, where oncology products are priced today versus antibiotics.
You know we haven’t made any future decisions about what our pricing strategy is going to be. I think we’re quite pleased today within the product back in the market and with having a reliable product supply.
You know where exactly VIBATIV is going to be slotted in still remains to be seen. You know, certainly, we have opinions about where it would ideally fit based on the label that we have out there. But, again, you know, we’re very, very early into the launch and you know we’re seeing how this product goes.
There’s a very limited level of support with the product today. It’s principally being out in the market through the distributors. But, again, I would stay tuned and we’ll get more information as we go forward here and gather details on how the product is ultimately being used. I’m pretty sure we won’t price it at that oncology-like product price. That would be a little bit uncompetitive, I would guess. But where there’s opportunity, we’ll have to see. Rick?
Rick Winningham
Yes. I think that’s right. I think we’ve introduced the product at a price that’s higher than price that was the product was being sold when it was with Astellas. I think the market reception that I’ve heard has been physicians have welcomed the product back on the market.
We have gotten some reorders. But it’s early stages, and I’m just very happy that we’re finally able to get a half that label and get the product back on the market, where it can provide some help to patients and over the long-term, provide some benefits Theravance Biopharma.
Brian Skorney – Robert W. Baird & Company, Inc.
Mike, can you give us any color on how milestones are going to flow with the approvals and commercializations of BREO?
Mike Aguiar
Yes. I can give a little more insight, just as a quick bit of history, say we’re on the same page. There are two milestones we’ve paid to date. One was a $350 million milestone for the US approval of BREO. And one was the Japanese approval of RELVAR.
So, looking forward, the potential milestones ahead of us are something related to the US launch of BREO. So obviously, that’s not too far in the future.
I would say think about it in similar magnitude to the approval when we had. Although, we haven’t exclusively given guidance around that. Obviously, there’s going to be a Japanese launch at some point. Again, the relative size that I would say is similar in nature. But, again, we haven’t specifically disclosed the Japanese launch milestone.
And then, there’s some related to the other region, which would be Europe. And again, those, hopefully, will be the earned at some point in the not too distant future as well.
So, there’s a series of milestones that are related to BREO and then there will be a similar series related to ANORO. Obviously, we’re looking towards December 18 as a date where we’re hopeful to get approval in the US and so there will be a milestone there as well.
I would think about the milestones relative to ANORA being similar in size to those of BREO. So, I don’t want to go too much further now. But you probably could triangulate back relatively quickly to the grand total of $220 million, which is every product – if both the products are approved in all of the regions pretty quickly, what the relative magnitude of these were. So, it’s all going to depend on regulatory activities primarily they’re going to drive most of these.
Brian Skorney – Robert W. Baird & Company, Inc.
Great. Thanks. That’s helpful.
Operator
Okay, thank you. We’ll have our next question from Howard Liang from Leerink Swann. So, Howard, please go ahead.
Howard Liang – Leerink Swann & Company
Great. Thanks very much. Regarding the ADHD beta that we – I think we’re going to seeing soon. Can you talk about what you hope to see in the profile? And in the – how it might differentiate from other compounds for ADHD. Can you just give the sort of the overall differentiation of the product? Thanks.
Rick Winningham
Sure. So, this is the norepinephrine and serotonin reuptake inhibitor, it’s 9855. And, yes, it’s a little bit heavier on norepinephrine side than it is on the serotonin, if you look at the phase I data that we disclosed. The interesting aspect of the phase I data is relatively little to no nausea so you don’t get the –some of the GI upset that your experience with a drug that might be a little bit more heavily weighted to the serotonin side of the spectrum.
The other very significant advantage that TD-9855 has is a long half life. And you don’t get the peaks and troughs that you would get with cymbalta or animositin [ph] or with any other previously developed drug that has both activities.
It’s – you reach – you sort of get up and reach steady state; very constant levels, even for patients as late in a day taking a dose or misses a dose for a day. I think this is an advantage of the drug.
Its metabolism – there are a series of metabolic benefits versus other drugs on the market today. We want to of course see those, by and large, it’s just in the phase II study. That’s a characteristic of the product and the way that it was designed.
So what am I looking for?
Well, I’m looking for generally a well tolerated product that we’re having efficacy, that is comparable or better to adamositin [ph] and I think should we be able to see that and some additional patient reported outcomes that we are tracking in this phase II study, I’ll be very happy with the outcome.
I think we look – just stepping back for a moment, we look at the ADHD study in the fibromyalgia study sort of as a package because you can see this type of medicine and over the long term being developed for we’re seeing these conditions as well as pain.
And should we have benefits around cognition or tiredness that could potentially help a person with fibromyalgia and we see that in the ADHD study, then I think it will complement the fibromyalgia data assuming the fibro study is successful, that will complement the fibromyalgia data nicely.
Howard, make one point. It should be obvious. But this is a non-stimulant. You’ve seen a lot of press, New York times, Wall Street journal, industry press about concerns of stimulants. They are very effective in ADHD. They are used incredibly well and successfully in ADHD. But there is a concern about – in from a public policy perspective about stimulants and their broad use in ADHD in this particular product is a non-stimulant.
Howard Liang – Leerink Swann & Company
Great. 4208 the mechanized LAMA, when do you expect to start phase III and what will be the cost of the phase III program?
Rick Winningham
Yes. So, I think what we should expect through the course of 2014 likely is more – so both further dose refinement and potentially another phase II B study. So, you’d be looking at a phase III start. If everything went very well, late 2014 or early 2015 I think this is a very, very well trodden path. We’ve been through it. In a nebulizer, we believe we can execute it. And – but we’ve got to get there first with all the data that we collect.
I think we’ve a great base here from the first phase II B study and what we wanted to walk out of the first phase II B study was is this drug a once a day product? And the serial FEV 1 measurements gave us a great deal of confidence that it is a once-a-day long-acting muscarinic antagonist that provides clinically meaningful benefit when delivered in a nebulizer.
Now, separately and distinct from the nebulizer program, we are developing an MDI formulation with our long-acting antagonist and are working on a formulation that combines the antagonist the long-acting antagonist with an inhaled corticosteroid. That’s additional work that’s ongoing today and I would stay tuned for progress updates in 2014.
Howard Liang – Leerink Swann & Company
Can you say whether the cost is something that you can take on?
Mike Aguiar
Yes, I think we’re probably a little bit early on that as the data is relatively new here and we haven’t figured out every next step.
So, we continue to look at this program quite closely, how we are very excited about the potential of this product Like everything here at the Theravance, we are looking at the possibility of advancing for ourselves as well as the possibility of partnering it, and we have not made final decisions around that.
Clearly, if we made a decision to look forward in the phase II ourselves, we would consider the cost quite closely because that would be an important consideration.
But, again, sitting here today, other than being extremely pleased with the data, we haven’t made any final decisions about exactly how the next step is going to go.
Rick Winningham
I think technically, we feel pretty confident we can execute it. We’ll just have to see how the rest of the data rolls out, and then roll up the economics and go from there.
Howard Liang – Leerink Swann & Company
Okay. And just last question, VIBATIV, can you tell us what amount you put on the balance sheet for sales of VIBATIV?
Mike Aguiar
Yes. I’m not going to give an exact number here because we haven’t finalized the accounting and I wouldn’t want to come back and find out if the number is slightly different than what I mentioned. I’ll say it’s in the several hundred thousand range, something like that. There’s a number of inputs still to be determined before I can nail that down. But I will make two comments.
Although – you know one, we put out intentionally a signal intentionally a very small initial stocking that went out so there really was an intention on our part to manage this quite closely. And as a result, we have actually to date had significantly more reorders than the initial stocking size.
So, I would say stay tuned. You know we’ll have a little more data in the next quarter. And at that point in time, we’ll have a pretty clear view of how we’re going to account for this. But today, that was a – everything has gone according to our initial plans. And I would not think of that initial bolus – whatever that sales number is being in the stocking. It really has been more than the initial amount of reorders that we’ve seeing today so I think we’re relatively pleased
Howard Liang – Leerink Swann & Company
Thanks very much,.
Rick Winningham
Thanks, Howard
Operator
Hey, thank you. It appears we have no further questions on the phone. I’d now like to turn the conference back to Mr. Winningham. Please go ahead, Sir.
Rick Winningham
Okay. I’d like to thank everyone for joining us today. We – as I’ve said we’ve got a very exciting remainder of the year – a number of exciting catalysts; the 9855 data that will come shortly, the – hopefully, some additional regulatory news from Europe as well as the United States on the respiratory programs and further updates on the separation.
So I look forward to updating everyone throughout the remainder of the year on the progress of the Company. And again, thanks for listening today.
Operator
This does conclude today’s call. Thank you for your participation. You may now disconnect.