Merck & Co., Inc. (MRK) Q3 2013 Earnings Report, Transcript and Summary

Good day. My name is Patricia, and I will be your event specialist today. At this time, I would like to welcome everyone to the Cubist Pharmaceuticals Third Quarter Earnings Call. [Operator Instructions] And please note that today's web conference is being recorded. We will be taking questions over the phone at the end of today's presentation, and you will receive instructions on how to do so at that time. [Operator Instructions] At this time, I would like to turn today's program over to Eileen McIntyre, Vice President of Investor Relations. Eileen, you may begin.

Thank you. Good afternoon, and thank you for joining us for our review of Q3 2013 business performance and financial results for Cubist Pharmaceuticals. Before introducing our speakers, I will read the Safe Harbor statement and describe the context for use of non-GAAP financial measures. Today's presentation includes forward-looking statements relating to our business, including those set forth on this slide. We may also make forward-looking statements during the Q&A session following our prepared remarks. These statements are neither promises nor guarantees, and there are a number of risks and uncertainties that could cause actual results to differ materially from those set forth in these forward-looking statements. These and other risk factors are described in the Risk Factors section of our most recent quarterly report on Form 10-Q filed with the SEC. Forward-looking statements are made as of today's date, and we do not undertake any obligation to update any forward-looking statements. We will also refer to certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding Cubist's operating performance. Please refer to the slide being shown regarding our use of non-GAAP financial measures, as well as additional slides on the Investor Relations page of our website, which contain the reconciliations between our non-GAAP financial measures and GAAP financial measures. Speakers on today's call will include: Cubist's CEO, Mike Bonney; President and Chief Operating Officer, Rob Perez; Chief Scientific Officer, Steve Gilman; and our Chief Financial Officer, Mike Tomsiceck. We'll first hear from Mike Bonney. Mike?

Thanks, Eileen. In the past few months, Cubist has delivered a series of important value creating milestones. We are building a future consistent with our strategic focus on acute care therapies, well aligned with today's evolving healthcare delivery environment. The accomplishments of the past few months have demonstrated that the organization we have built has the creativity and prudent risk-taking ability to achieve the objectives we set forth in our Building Blocks of Growth Goals last year. On the top line, our Building Blocks of Growth established a goal of $2 billion in total annual revenue by the end of 2017. We believe that the approved therapy DIFICID, which we would own following the closing of the Optimer acquisition, and the late stage antibiotic candidate tedizolid phosphate, now a Cubist to asset based on the completed acquisition of Trius last month, can both contribute meaningfully to achieving this $2 billion revenue goal. As Mike Tomsicek will discuss in greater detail, our convertible debt transaction last month created a capital structure that will support execution of our plans through the Building Blocks of Growth period. Our revenues today reflect the continued success of CUBICIN and increased off-line contributions from the sales of ENTEREG. Our total net revenues of about $266 million for the third quarter, and nearly $755 million year-to-date, keep us on track to achieve our first year with at least $1 billion in total revenues. With our recently announced acquisitions, Cubist has expanded its global leadership role in the discovery, development and commercialization of badly needed antibiotics, to treat serious infections caused by multidrug-resistant bacteria. A few years ago, the Infectious Disease Society of America issued a challenge to industry and public policymakers, demanding that we find a way to deliver at least 10 new antibiotics by the year 2020. Assuming the successful closing of the Optimer acquisition and success in the clinic and regulatory approval for our other late stage antibiotic candidates, Cubist will be responsible for at least 4 of the 10 antibiotic therapies sought by 2020. As Steve Gilman will detail, we are nearing important milestones for 2 of our late stage antibiotic programs, with an NDA just filed for Tedizolid, and Phase 3 top line upcoming for ceftolozane/tazobactam. We'll focus our prepared remarks this evening on providing context around some of these accomplishments, as well as reporting on developments against future milestones. I'll now turn the call over to Mike Tomsicek for a review of our financials. Mike?

Thanks, Mike. Cubist has taken some very important steps this quarter towards achieving our long-term Building Blocks of Growth Goals. I'll start with an overview of Cubist's capital structure, which now reflects our convertible debt transactions, as well as the completion of the Trius acquisition in the third quarter, while anticipating the closing of the Optimer acquisition later this week. On September 10, we announced the completion of a convertible bond offering, for a total of $800 million with 5 and 7-year maturities. The financing was sized, anticipating Cubist's needs to fund the acquisition, including the associated CVRs, while allowing us to continue to pay to develop our strong pipeline using operating cash. Our cost of capital net of tax for the combined debt and hedges is just over 1%. With an effective conversion premium of 55% that manages future dilution. Cubist also negotiated a series of private transactions that converted almost 50% of our outstanding 2017 convertible bonds to shares, thereby reducing our overall debt leverage by retiring bonds that were well in the money. The face value of the remaining 2017 converts is now just under $230 million. The terms of the total financing package were favorable, and as a result of these transactions, Cubist has a capital structure in place that offers flexibility and supports the pursuit of our Building Blocks of Growth goals. Now I'll comment on the few numbers in the Q3 financials that we distributed this afternoon. First, total revenues at $266 million are strong, with growth of almost 12% versus Q3 a year ago. CUBICIN net revenues results in the U.S. showed 10% growth versus Q3 last year, good to see 10 years after the launch of CUBICIN. ENTEREG net revenue showed continued momentum, with Q3 growth at 36% versus Q3 last year. One note on gross to net impacting U.S. product revenues for the quarter. As you may recall in Q2, we reversed some revenue reserves for Medicaid, based on rebate claim activity and information received from certain states. As a result of additional information received during the quarter, we have further reduced our Medicaid rebate reserve in Q3. Our Q3 gross to net percentage was 12.4%, including the adjustment. The adjustments impacted our growth to net percentage for the quarter by approximately 2 percentage points. Service and other revenues came in at $9.4 million. This reflects the extension of the co-promote agreement with Optimer to support DIFICID until the acquisition closes. Also included for Q3 is a $5 million revenue related milestone earned from Novartis. COGS and gross margins are both on target for the quarter. SG&A is up, primarily as a result of the recent M&A activity. There are $28 million in transaction charges reflected in SG&A for the quarter, and generally higher levels of G&A expense associated with heightened headquarters activities through this atypical quarter. The increase in R&D for Q3 is primarily driven by 2 things. The first are some transaction related expenses associated with accelerated options vesting for Trius employees. The second relates to significant progress made in the third quarter to secure manufacturing capacity for a launch of ceftolozane/tazobactam. We expect that undertaking 2 acquisitions and completing the associated financing would lead to significant onetime transaction-related costs. You've already seen this reflected in some numbers I've just discussed. This slide shows how the almost $40 million in acquisition-related expenses booked in Q3 impacts operating income. Operating income came in at $4.1 million for the quarter. Our non-GAAP adjusted operating income for the quarter was $52.5 million. Turning to cash. After completing financing in the closing of the Trius acquisition, our cash, cash equivalents and investments as of September 30, totaled just shy of $1 billion. For year-end guidance, we now expect cash, cash equivalents and investments of around $550 million. This assumes the closing of the Optimer acquisition in the near-term. Now turning to the balance of P&L guidance for the year. And these numbers do not include the impact of anticipated Optimer acquisition. First, revenues. As you'll see on this slide, we are tightening to a total revenue range, just over $1 billion in the middle of our previous range. For U.S. CUBICIN revenues, we are shifting our guidance to a range of between $885 million and $900 million, based on the level of clarity we now have, based on 3 quarters of data and our view of U.S. market conditions for the balance of the year. More on this from Rob later. For the longer term, we remain confident that this well-differentiated therapy will achieve peak year sales in the U.S. exceeding $1 billion. As expected in our long-range plans, the cash flow associated with CUBICIN will continue to be the foundation of our success for years to come. Increases in expected revenues from other sources result in a midpoint for total revenue guidance that is essentially unchanged for 2013. For revenues to Cubist from x U.S. sales by our partners, we are tightening full year guidance range at $56 million to $58 million, the upper end of our previous guidance. For ENTEREG, we are bringing guidance to around $50 million, also at the top of our earlier range. And for service and other revenues, our increase in guidance to around $24 million includes an extension of the Optimer co-promote through Q4. Our guidance today does not include anticipated product revenue from direct sales of DIFICID, following closing of the Optimer acquisition. We are making no change to guidance for COGS and gross margin. Within operating expenses, R&D guidance is now in the range of $465 million to $485 million, reflecting the added expenses in 2 areas that hit Q3 as I described earlier, as well as the addition of Q3 and Q4 operating costs associated with the Trius programs, in particular, for the antibiotic candidate, Tedizolid. Contention consideration is unchanged. SG&A guidance is now in the range of between $235 million and $250 million, reflecting the items I mentioned for Q3 expense, in addition to some anticipated closing costs for the Optimer acquisition that are already known. Other income and expense guidance is now an expense of $70 million. The difference from earlier guidance is entirely driven by finance-related charges. For the year, our guidance for operating income is now $25 million to $35 million. The guidance for non-GAAP adjusted rate -- adjusted operating income is between $175 million and $195 million. Finally, while we don't provide formal tax guidance, I did want to set expectations here. Given the impact of M&A, you should expect to see a small tax credit for the year. The tax rate in this circumstance is not a very informative number. Now, I'll turn the call over to Rob for his review of operations.

Thanks, Mike. I'd like to begin by stating how proud I am to be part of Cubist today. The Trius acquisition we have now completed gives Cubist a unique complementary late stage asset. Assuming approval, Tedizolid will be an excellent fit with the acute care commercial capabilities we have today in the U.S. and those we expect to build for the launch of Tedizolid and ceftolozane/tazopbactam in Europe and some other markets outside the U.S. Our operational focus for Tedizolid following the Trius closing, has been to ensure continued focus in the near-term on key activities, including the Tedizolid regulatory filings in the U.S. and Europe, and preparations to initiate the Phase III pneumonia trial. The integration is progressing well, and as you saw this morning, we have filed with the FDA for initial approval in acute bacterial skin and skin structure infections, and are on track against these additional important milestones for Tedizolid. The Optimer acquisition, which we expect to close this week, is also an excellent fit for Cubist. DIFICID, which we are continuing to co-promote through the close of the Optimer acquisition, will be highly complimentary to the commercial infrastructure we have built. Launched just over 2 years ago, DIFICID is the first new therapy approved by the FDA for the treatment of clostridium difficile-associated diarrhea, or CDAD, in 25 years and has labeled superiority in sustained clinical response, helping to address the serious problem of disease recurrence associated with older therapies. The CDAD market represents an important area of medical need across the globe. As you may have seen, the U.S. Centers for Disease Control last month classified CDAD as an urgent threat to public health. The CDC estimates that CDAD leads to at least 14,000 deaths every year in the United States alone. Assuming a positive outcome of the Optimer shareholder meeting this week, we will quickly move into action for that integration, and as we do so, we will focus on accelerating momentum for DIFICID sales in the U.S. and Canada. The expanded product portfolio Cubist is building is well aligned with the important changes in how healthcare is delivered, and I'd like to spend a few minutes on this topic today. You may have seen news about M&A activity involving U.S. hospitals over the past year. Large academic hospitals are being combined with community hospitals, outpatient clinics and physician practices. The evolution of healthcare in the United States is changing the delivery of medical care, in both the inpatient and outpatient settings. At the same time, a slow economic recovery, changes in reimbursement, sequestration and some uncertainty related to the impact of the Affordable Care Act, are all adding stress to an already tumultuous period for our hospital customers. During this period of transition, we continue to learn rapidly and adapt to changes in customer behavior on an institution by institution basis. The acute care institutions we call on the U.S. are evolving along a relatively consistent continuum. Integrated care organizations are seizing the opportunity to invest in the reinvention of healthcare delivery, with the focus on outcomes and total cost of care. The Cubist product portfolio fits well with this value based approach. Some hospitals, still early in their evolution, may still be focused on siloed cost reductions to address lower reimbursements resulting from the Affordable Care Act-related penalties and the recent 2% sequestration of CMS payments. Most of our customers are somewhere in the middle of this change continuum. Over the longer term, we believe those delivery models that emerge as best in class, will need to align with the quality metrics defined by CMS's value based purchasing. The Cubist U.S. commercial organization is responding to our customers wherever they lie on the change continuum. On a share of days basis within the MRSA therapy market, CUBICIN continues to perform well, with about a 14% share of market for the year-to-date period through August. However, the total MRSA market days of therapy continues to be fairly flat, down about 0.5% for the year-to-date period through August. Reports also indicate that hospital census has been flat to down this year. As a result, while CUBICIN net revenues saw year-over-year growth of more than 10% in Q3, we did see some pressure on CUBICIN volume, which is down 1% in vials for Q3 versus a year ago. As Mike T. mentioned, we adjusted our guidance range for CUBICIN U.S. net revenues for the year to a range of $885 million to $900 million. On a global basis, we expect CUBICIN to reach blockbuster status this year, with anticipated end-user sales including product revenues realized by our x U.S. partners, exceeding $1 billion. For the longer term, we continue to be comfortable that CUBICIN will achieve peak year sales in the U.S. of greater than $1 billion. As the hospital inpatient environment continues to be the setting where the sickest, more complicated patients are treated, the CUBICIN bacteremia indication continues to be an important differentiator. And for appropriate patients, CUBICIN once daily administration, either the 30-minute infusion or 2-minute push, fits well with transitioning these patients to lower cost, outpatient care settings. In those highly integrated health systems that are further along the continuum of total health outcomes management, CUBICIN has continued to see outpatient growth. In these systems, our growth in outpatient year-to-date, outpaces what we see for the U.S. as a whole by more than 5 percentage points. For CUBICIN sales outside the U.S. in Q3, Novartis passed a cumulative sales threshold, and Cubist earned a milestone of $5 million for this achievement. Also in Q3, the AstraZeneca CUBICIN team in China gained approval of a full label, which now includes indications for both Gram-positive, complicated skin infections and bloodstream infections along with the 2-minute infusion. Q3 was a strong quarter for ENTEREG, reflecting the well targeted activities of our U.S. commercial organization. In Q3, ENTEREG net revenues were up 36% versus a year ago. We are now looking forward to launching the expanded ENTEREG label. The FMDA approval we announced yesterday expands the indication for the use of ENTEREG to accelerate the time to upper and lower GI recovery, following any surgery that includes a bowel resection with primary anastomosis. The initial indication for ENTEREG was more narrowly defined. Primary support from this label expansion was a Phase IV trial in patients undergoing radical cystectomy. In this trial, patients treated with ENTEREG showed a mean reduction of 2 days in time to discharge from the hospital. We believe the expanded label for ENTEREG will help to further increase top of mind awareness among the general surgeon audience, and also help introduce ENTEREG to urologists who specialize in bladder cancer surgeries, an audience who have little awareness of the product today. Next, I'll provide a quick update on our plans for building commercial infrastructure x US. Assuming a positive vote by Optimer shareholders tomorrow, and a close on this transaction in the next few days, our x US expansion will begin with the integration of the current Optimer Canadian commercial operation. As we've mentioned in the past, we plan to build a commercial presence in Europe, as well as Australia and New Zealand, assuming positive data later this quarter from the Phase 3 trials for ceftolozane/tazobactam. We would expect to accelerate the European portion of this plan x U.S. commercial build for Tedizolid, for which we are targeting an MAA filing in the EU in the first half of next year. Meanwhile, our acute care commercial and medical affairs organizations are continuing their planning for the anticipated launch of ceftolozane/tazobactam on both sides of the pond, and they are charged up about the prospects of introducing additional therapies that target infections caused by multidrug-resistant bacteria. Now, over to Steve.

Thanks, Rob. As announced earlier, we've now filed the 2 NDAs for Tedizolid, seeking approval for both the IV and oral forms for serous skin infections caused by certain Gram-positive pathogens, including MRSA. This was consistent with our initial acquisition expectations for submission timing and I want to thank the team for not missing a beat, as the FDA reopened for full business late last week. Assuming FDA acceptance of the submission, and given that Tedizolid has received QIDP designation, we expect the PDUFA date to be in June 2014. Also regarding Tedizolid, working with our Bayer colleagues, we expect to initiate the planned Phase 3 program in nosocomial pneumonia in the first quarter of 2014. For ceftolozane/tazobactam, we are in the final stages of completing the complicated urinary tract infections, or cUTI and complicated intra-abdominal infection, or cIAI trials. Last patient, last visit has been achieved in both indications, and we are entering the data in -- data cleaning and analysis phase. We continue to expect to be able to announce top line data in both of these indications by year-end. Our current expectation is that the cUTI top line will come first, and should happen in November, while the cIAI top line data will likely come in late December. As I've said in the past, our focus at this stage is on the quality of execution, not on a race to the finish line. Assuming positive data from both trials, we would expect to submit an NDA for ceftolozane/tazobactam within 6 months of the cIAI top line announcement. For those of you listening today who may be new to the Cubist story, ceftolozane/tazobactam is an antibiotic candidate, that if successful, will provide an important new therapy to treat certain infections caused by Gram-negative bacteria, including a multidrug-resistant strain of Pseudomonas aeruginosa, and ESBL-producing stains of bacteria such as e. coli and Klebsiella. Due to the size of the unmet medical need and the unique and compelling profile of ceftolozane/tazobactam, we believe this is an asset with blockbuster potential. I have an important and quite positive update regarding our plans for the Phase III study of ceftolozane/tazobactam and nosocomial pneumonia. As discussed last quarter, based on some new guidance issued in June, we re-engaged the FDA to discuss options for our path forward for ceftolozane/tazobactam and ventilator-associated pneumonia. We had a very collegial and interactive discussion that led us to mutually agree that continuing with a modified version of our original registration supporting trial, provides the optimum path forward to approval in this indication. This is based on some significant negotiated changes in the original protocol that translate into a reduction in total patients of about a third of the initial 950 patient enrollment target, which will make this trial more efficient and less expensive to conduct. These changes include: Using the intent to treat or ITT population, rather than the microbiologically confirmed ITT population, as the primary analysis set; we also gained agreement to use -- for the use of meropenem rather than imipenem, as the comparator age. Meropenem had been our original choice of comparator, and we believe this change will also help speed enrollment, as it is more globally available, more widely accepted as a standard of care. It does not require complex dose adjustment in renally-impaired patients. We will now proceed with this modified version of our original protocol, rather than transitioning to a pathogen-specific approach, and plan to initiate this trial in the first half of 2014. I have to say that in my 30-plus years in the industry, I have never felt a more collaborative facilitated environment at the FDA, and this result is another great example. Enrollment in our other Phase 3 development program, surotomycin and bevenopran continues. Also on track is the expected unblinding of AYX1 Phase II pain study in time to allow for a go/no go decision, and our option to acquire Adynxx later -- early next year. Now, back to Mike.

Thanks, Steve. The progress Cubist continues to make against both our near-term and long-term goals is highly dependent on the focus, commitment and teamwork of all of our employees. We believe Cubist's highly differentiated culture continues to be a key foundation of our success. I want to thank all of our employees, including those at the former Trius headquarters in San Diego, for their important contributions to the accomplishments of the past quarter. The next couple of years hold great promise in moving us toward the achievement by 2017 of our Building Blocks of Growth Goals. In the more immediate term of course, we are looking forward to announcing top line for the initial Phase III trials of ceftolozane/tazobactam. With that, let's open the line up for your questions. Operator?

[Operator Instructions] Your first question comes from the line of Adnan Butt.

I have 2 questions. First, maybe Mike or Steve. How confident are you that the 2 Phase III studies could read out in the fourth quarter? What's the chance of slippage into first quarter for intra-abdominal, if any? And second question, this is Steve-specific. Steve, the most common question I get is, what gives the company confidence that the non-inferiority end point can be met in the cIAI indication specifically, just because the Phase II data didn't show better efficacy than meropenem? Can you shed some light on that, please?

Steve, go ahead, yes.

Yes. Well, with respect to the timing, these are the best estimates we have. Assuming everything goes smoothly, we should be straight on track for those, so there's always a possibility of a week or so, but we don't think that will happen, so that's why we gave those numbers for those deadlines. With respect, if you know the Phase II IAI trial of meropenem, was a couple of percentage points higher, well that was because it's a small trial, and actually each patient was 4% different, but we looked at that trial as being very favorable, with respect to reaching a non-inferiority margin. The current trial that we have ongoing, of course, is a very much larger trial. Yes, very much larger trial, and we feel very confident that the trial's designed in order to achieve success, and that the molecule will do that, so. And the other thing about that trial by the way, the Phase II trial, was we used a 2 to 1 randomization instead of a 1-to-1 randomization, which we're doing in the Phase III.

Steve, on the nosocomial pneumonia study, what -- so you updated the trial design. Can you be a bit more specific about patients, the end point and the timeline? And that's it for me.

Yes. The -- basically, the pretty much, the key parameters of the trial, at 10% non-inferiority margin all caused mortality as the end point, were the same, the 1-to-1 randomization, now the comparators, meropenem, instead of imipenem, so all the other parameters of the trial are essentially the same, as the power of the trial doesn't change. So it was simply updating some of the particulars about other aspects that, like ITT analysis population, that helps speed the trial. And as I said, we're intending to get that trial kicked off the early part of next year.

The key issue here, Adnan, is that the move from MITT to ITT results, and a reduction in the total number of patients that need to be enrolled of about 1/3. So the trial will end up with about 2/3 the patients we originally expected, and given that, that should result in a quicker trial enrollment and certainly less cost, given the cost per patients in these clinical trials. We're not going to give you specifics at this point, I think history would suggest to us that we see -- get some real accrual data before we start declaring how long it's going to take.

Your next question comes from the line of Terence Flynn.

I was just wondering if you could speculate if you expect the FDA to convene an adcom here to review the filing, and if so, what do you expect the key questions they might ask?

Sure, Terence. I think that given -- I think it was NUFA 5 [ph] or FDASIA , virtually all new chemical entities, which Tedizolid is, will require an advisory committee. So we are certainly planning for that. With respect to what the key questions will be, I think it's way premature to speculate on what those questions would be.

Your next question comes from the line of Mark Goodman.

Operator, maybe we should go to the next questioner and come back to Mark.

Sure. Your next question comes from the line of Jason Kantor.

Operator, you're sure their lines are un-muted?

One moment. Mark Goodman, your line is open.

Operator, we're still not hearing any questions from Mark.

Your next question comes from the line of Steve Byrne.

So a couple for you, Rob. The DIFICID scripts trends have not look very strong in recent months. Is there anything fundamental there that concerns you or do you just see this as being a lack of commercialization focus, given the uncertainty that must exist with Optimer reps?

Yes. Steve, I can't comment specifically on DIFICID other than as a co-promote partner because we don't own the company yet. But suffice it to say, we remain very excited about acquiring the company and the potential of the product. I wouldn't really take too much account of how the drug is doing right this second. As you can imagine, there's a lot of uncertainty, and the ability to get everything focused on the drug is rather difficult during this time. But soon, we expect that we'll complete the acquisition and we can line up behind the drug the way we expect to, and we remain very bullish about DIFICID's future. So just give us a little time and then we can come back to you with what we think we can do with this drug.

Okay. And you also mentioned a modest contraction, year-to-date, in MRSA prevalence. Is that any particular indication of infection or is that community acquired or hospital acquired, any greater granularity you can provide?

It's a good question, Steve. And we don't have a lot of detail on it. I don't have any epidemiologic data, for example, to say that -- is there a changing of the bacteria? We certainly have seen it across the country, it hasn't been in any particular region. But it is a flattening of the MRSA market. I do think there are a couple of things that are driving this trend, some of them related to the health care delivery changes, that I talked about, and that there's a lot more focus on treating patients outside of the hospital than in the hospital. And I know that kind of impacts our inpatient versus outpatient use, and also signals some of the opportunities for oral therapies, which is why we were so interested in Tedizolid. So I think that it's a combination of maybe some changes in just MRSA, generally, but I think what's probably a more telling statistic is the fact that more and more patients are being treated outside the hospital and more and more hospitals, as they integrate, are finding ways to treat patients without admitting them in the first place and certainly getting them back out into lower-cost treatment settings. So that's good for CUBICIN, because of its outpatient use, and also good for Tedizolid as -- hopefully if it gets approved.

I just want to be clear though. The comment that we made about the decline, I think it was 7/10 of a percent year-to-date, is driven by a complex calculation of days of therapy of the drugs in the marketplace and the hospital channel, not by -- as Rob said, not by epidemiological data.

Okay. And I have one for Mike T. The share count at the end of the quarter jumped. Is that a result of the conversion of the older converts into shares? And can you just explain that again on what you expect the debt to be at year-end versus where it is right now?

Yes. The share count will increase as a result of the settlement of shares that we mentioned, approximately a $7 million -- 7 million share increase to basic shares. And the level of debt, I think at just over $1 billion should be fairly stable now going forward.

Your next question comes from the line of Marko Kozul.

I'd like to start with Tedizolid. Can you maybe walk us through your longer-term strategy views and any market research you may have regarding positioning and potential to maintain premium pricing -- premium-branded pricing in the years ahead?

Yes. Marko, this is Rob. I'm not going to give you the full playbook, but I can tell you a few things that make us excited about Tedizolid. First of all, I think, as you look at Tedizolid, the natural differentiation point is relative to linezolid. And certainly, we think that Tedizolid has advantages over linezolid but we're really thinking that this product can be positioned where outpatient therapy is appropriate. So all of the new MRSA agents that are looking to capture this trend to treating people outside the hospital, we think that we've got the best drug because it's an oral once today. So I think that's the first point. But we do think that it has a lot of differentiation versus linezolid, and even a linezolid that, ultimately, is off-patent, things like the fact that it's a shorter course of therapy, 6 days versus 10, and as I mentioned, is dosed only once a day. It also works in ZYVOX-resistant patients. So its potency both in ZYVOX-resistant, as well as in ZYVOX-susceptible patients is 2 to 4x greater. Also some -- linezolid has some issues with drug-drug interactions that we think could be advantageous for Tedizolid. We'll have to see what kind of shakes out in the label, ultimately, but we do think that the profile of the drug will allow it to be used in some settings where linezolid just isn't appropriate. So there's a lot of areas of differentiation that we know from -- in talking to physicians and from our own kind of commercial insight that we think can be very interesting and can help drive utilization of this product. And while we won't give the full playbook, I can tell you that we remain excited about it. The other point, Marko, just that I've failed to mention is, obviously, this product will also give us an entry into pneumonia, which is an area that -- Gram-positive pneumonia which we don't have with CUBICIN. So that's another expansion of where we can offer therapies for patients.

Your next question comes from the line of Mario Corso.

CUBICIN, I was hoping you could maybe walk through some of the swing factors you're looking at for fourth quarter. It's a pretty wide range of expectations when we look at your guidance. And I'm wondering how you're thinking about volume and discounts and the price effect as we end the year there. And then also I wanted to ask, in terms of financial guidance, if you plan on saying something before the end of the year for the integrated company or whether this really becomes a 2014 planning event? And then finally, I guess, commercially, as we think about Tedizolid launch, perhaps middle of next year, ceftolozane later in the year, early the following year, I'm wondering how you're thinking about what, if any, changes will need to be made to the U.S. rep count or commercial organization?

Sure, Mario. Let me handle the middle one, the financial guidance, just so we're that clear on that, and then I'll turn the other 2 over to Rob to address. Look, we don't yet even own Optimer, that should occur later this week. What we have done historically and what our current plan is to do, is to provide for you on our year-end call, which will occur in January, a guidance for 2014 and that will reflect, basically, the integration of both companies and what we're calling internally, Cubist 2.0. So stay tuned for that. I think -- I don't want to get out in front of this, execution is everything here and we won't even get into Optimer until, hopefully, sometime later this week, assuming the shareholder vote goes the way we expect it will go. So with that, let me turn it over to Rob to talk about CUBICIN, Q4 and U.S. commercial organization.

Yes. So in terms of swing factors, Mario, I know the numbers may appear -- the variance in the guidance may appear large, but frankly, it really is a function of the size of CUBICIN. Now with a product that -- we're talking about between $885 million and $900 million, any 1 day, swinging one way or the other at the end of the year, can have a different -- can make a difference in that overall Q4 numbers. So part of it is just the sheer size of the product. But ultimately, what will drive Q4 is going to be what happens with the overall MRSA market. We continue to compete well so I expect that trend to continue, but really, it's going to be kind of a market force, I think will be the biggest determinant of where we come in within that range. But the range isn't really as big as you think when you realize that the size of even a day of CUBICIN, which could move from 2013 to 2014. Now, regarding the commercial organization as we move forward, we're spending a lot of time looking at what we need to be able to optimize our approach with this new anti-infective portfolio, as well as to ensure that we continue the momentum that we're seeing and very excited about with ENTEREG. So we're not going to give the numbers. We're not expecting a massive overhaul of the commercial organization, but we are looking for some capabilities that we didn't have before. In particular, some areas in the retail setting and coverage of national accounts that we really didn't have to cover previously. There also are more hospitals that we're going to cover now with the addition of DIFICID and Tedizolid than we covered before because the overlap, while significant, does kind of expand on kind of both edges. So stay tuned for our guidance and expense announcement next year. But I think the bottom line is it's not a massive overhaul, but it is some tweaking of our commercial organization in order to optimize what we can do with these therapies.

Your next question comes from the line of Greg Wade.

Rob, I was wondering if you might educate us a little bit about CUBICIN's use in the home care setting. It's my understanding that most home care use of the product is as a result of step-down therapy from folks who had been admitted to hospital. Perhaps you could give us some metrics around what you think home care use is, never been admitted versus never admitted? And then where do you think you stand versus the next most prevalently used product in that setting? And then maybe outline for us, what is your commercial posture to expand use of CUBICIN in never-been-admitted-to-hospital patients?

Sure. Home care continues to be a significant chunk of our outpatient use. I can tell you that home care has been -- the home care providers have also seen a bit of a reduction of patients in general, not just CUBICIN patients but in general, that I think reflects some of the hospital census data that I mentioned in the script. But CUBICIN continues to be a significant fit within home care I don't have a specific market share on whether we're the market share leader within home care, but I would guess that we're -- if we're not the leader, we're close. Certainly we're the leader in dollars in the MRSA space in home care. But it continues to be a significant kind of portion of our outpatient use. I think one of the other questions you had was, are the patients going directly into home care or are they predominantly coming out of the hospital? And the large majority of patients come from the hospital. Home care is used as a step down for CUBICIN. And I think one of the trends that we're seeing, Greg, is that there is more of a concern within hospitals and integrated systems, in particular, to look at hospital avoidance. And I think while CUBICIN is a potential fit there for the more-sick patients, it's actually unlikely to be the best fit for that particular patient type because CUBICIN patients are the kind of sickest of the sick, and those are the patients who are likely to be admitted. What we are seeing, though, is we are seeing more tactics within hospitals to try to avoid admitting patients. And again, this is one of the drivers of our acquisition of Trius, because we do think that an oral therapy, in that setting, can be a significant plus. And that's an area that we never got with CUBICIN before, and we don't think that we would be that well-suited to get in the future. So I think you'll see more inpatient use of CUBICIN, frankly, relative to what you saw in the past, going forward, just because of the way health care is changing and that will create more of an opportunity for Tedizolid.

Okay. So just maybe help us to understand where the call point is for Tedizolid and, maybe, hospital avoidance for CUBICIN, whether you're hitting that call point now. And then I guess, the color is, is there going to be any efficiencies or are there going to be any efficiencies once this drug is approved?

Yes. The good news is the call points are pretty much the same. When you talk about outpatient, the outpatient use of CUBICIN is all driven by the same call points that we call on in the inpatient for the most part. The actual home care centers, or the places where the product is used, it's more of a delivery channel than it is a decision-making point. So that's really not a reason that we would need to expand our commercial footprint.

Your next question comes from the line of Alan Carr. Alan Carr - Needham & Company, LLC, Research Division: Rob, I was wondering if you could comment a bit more on the continuum. You mentioned earlier in the call, during the script, I guess, you mentioned that those hospitals are still in this silo of thinking are a bit of a drag here. Can you tell me about the evolution of the hospitals through this process? And is your expectation here, that you're going to -- that growth might pick up again as more move through to the other end of the arrow, to the right end there?

Thanks, Alan. I could tell you that we're very encouraged by the direction that hospitals are moving. And frankly, the hospitals and hospital systems that tend to be the thought leaders and those viewed as the most advanced in dealing with this kind of overall-integrated care, tend to be our -- some of our best customers. That's one of the reasons for the data point I mentioned in terms of our share in those environments. Though I do think that it's reason for optimism that as hospitals continue to move on this continuum, they will look more favorably at total cost of care solutions, where our products, not just CUBICIN but all of our products, fit very well. Where we're challenged is in those institutions whose kind of eyes are spinning because of all the changes. And they're going at it with just a silo of cut, cut, cut mentality. Because, obviously, if you're just looking at the pharmacy budget, it's going to be hard to see the economic or value advantages of a high-priced branded product. So the more institutions are being forced, and they are being forced because they're not going to cut their way to success within this new environment, the more they're forced to look at the total cost of care, the better it is for us, for all of our products, because all of our products, the reason that we've acquired them or that we brought them in is because of their advantages in overall value. Alan Carr - Needham & Company, LLC, Research Division: This may be hard to do, but I'm wondering if you can quantitate it in a way. I mean, if you go back a couple of years ago, was a noticeable number of these farther to the left? I mean are you seeing progression here to the right, or is this something that, I mean, you would expect to happen where you will actually see some movement?

We're definitely seeing progression. I don't have -- I can't quantify it. But I guess I would say that there may be was -- on that continuum, there was even a section to the left of hospitals that we're blissfully unworried, not worried at all about any of this changes and they weren't even thinking about costs, and we certainly benefited from some of that, but that's gone away, so we think so. Many of those hospitals are moving into the "oh my gosh, what do we do" setting right now. But the good news is, again, when you look at those institutions, and I won't name them, but those institutions that other hospitals look to as, "Hey, what are they doing?" Those are the places where we're doing the best. And so I think that as these organizations move down this continuum, it will be a good thing for Cubist and our products. Alan Carr - Needham & Company, LLC, Research Division: Okay, that's actually pretty helpful. And, Steve, now that Trius is part of Cubist, maybe you've had some time to look through what's going on, research-wise, there. Do you have plans to -- they had a few early-stage compounds, any updates there in terms of what you might bring forward there and how much overlap there is with what you guys had going on, in-house, at Cubist?

Well there's certainly overlap in our interest in antibacterial discovery, so that's good. The target they've been working on, DNHR, is something that we haven't been working on recently, because we had a hard time solving that problem, quite frankly, and they've seen to have made some progress and we're looking at it now. So there's no major update, we obviously have them closed, we're starting to meet with them on a regular basis, really get into the technical details, and we'll be making some determinations as time goes forward, as to whether we can pull something out of that or not. So we're still in the analysis phase, but it's still interesting for sure.

Your next question comes from the line of Irina Rivkind. Irina Rivkind - Cantor Fitzgerald & Co., Research Division: I just wanted to understand the pneumonia study for CXA-201 in a little bit more detail. Because you don't have to identify the organism before you enroll the patients, are you at all concerned about the patients having bacteria that don't respond well to the CXA-201 medication rather than Pseudomonas? That's Question 1. And the second question is about the OIC Panel that is scheduled in March for Salix. I was just wondering, if this is a broader panel, if you've been invited to attend. And if so, kind of maybe, what your thoughts on the panel are?

Okay. Well, with respect to the activity of ceftolozane/tazobactam, it certainly covers many of the key pathogens that occur in pneumonia, not just Pseudomonas because it covers Klebsiella, which is another major path to E. coli, it is obviously less prominent in pneumonia. So we're not over -- at all worried about the spectrum being a mismatch at all for pneumonia. And so if that answers your first question. Secondly, on the OIC, yes, we know about that, that ad board, we will be there, we haven't received a formal invite yet but some conversations with them we expect that to be a multi-sponsor kind of event that we'll certainly participate in. And outcomes on that, we'll just have to see the meeting when it happens.

If I can expand a little bit, Irina, on Canthrone [ph] ventilator-associated pneumonia, we will still require the investigators to try and get a sample. The issue is -- so the protocol will be executed very similarly. The difference is that in the previous version, the primary analysis population is the mITT, and now the primary analysis population is the ITT. And that -- what that does is it means -- and I think it's a recognition by the agency that getting these good-quality bacterialogic samples out of a lung is challenging. And so the number of patients that we would have to exclude from the analysis for an mITT gets smaller. But all the screening that we have planned to do will be done in this new study.

The next question comes from Ken Cacciatore.

Just wanted to ask on the pneumonia study, if you could give us some sense of when the study would complete and when you would have data available? That's first question. The second question is, could you give us some sense of the cost of building a European and rest-of-world sales force?

Sure. So for pneumonia, we did address that earlier Brian. We're going to wait until we start seeing some accrual data before we declare when we'll get that done. But the fact that we'll only have to accrue about 2/3 of the patients, relative to what we have been planning to do before this most recent interaction with the FDA, I think, is a positive development, no question. In terms of the cost of the European build, we're not going to provide specific data, but let me give you a framework to think about this. Ultimately, the European, or as we would call it, international organization, which would include Canada, New Zealand, Australia, et cetera, will be slightly larger in total headcount than our current U.S. customer-facing organization -- commercial organization or clinical scientific directors. It will take as a few years to hire all those people because what we'll focus on initially is hiring key leadership, some of that has already begun, and that's both at the headquarters office in Zürich, as well as in some of the countries. But the big bolus of people, the salespeople, actually doesn't really get going until, not only do we get the MAA for Tedizolid and then hopefully assuming success of ceftolozane/tazobactam. But we have to then go through, in most countries, a pricing negotiation, health technology assessment. And so our goal here would be to have the salespeople onboard, something like 3 to 6 months, before we expect to get pricing in an individual country. So all in, it's probably something like, if you take today as 0, and it's really not 0 because we got a handful of senior people in the European office now, it's '14, '15 and probably into '16 before we have that organization fully staffed.

Okay. I just wanted to go back to the timing of the study, completion results, understanding that this is very much up in the air and hard to predict, but clearly has implications for the product launch in size and launch dynamics. Is there any way of narrowing down within a 6- to 8-month window, when do you think we would have that data available?

Well we certainly have internal projections on that. But again, I think, since this is the first-ever ventilator-associated pneumonia study and we're going to be starting 2 of them, one in Tedizolid and one in -- with ceftolozane/tazobactam, let us get a little bit of data before we put stakes in the ground too firmly here. But in terms of data, what you can rely on is the open label study, which we opened up earlier this year, it is actively recruiting patients and we expect to have data from that study sometime within probably the first 6 months of approval, depending on what the IAI and UTI data look like, 6 to 12 months, something like that. Hopefully that helps you a little bit.

Your next question comes from the line of Brian Skorney. Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division: Actually I have a couple questions on the VAP study. I guess, first, can you give us any of the details about the feedback you got on the pathogen-specific dialogue, was that an issue that the FDA is just not open to this type of design or was it feasibility from an IRB standpoint?

No. They're clearly open to that thing, what I think one of the major things we learned is they're more open to that intellectually if your product is very specific for a specific pathogen and is not at all broad spectrum. And really what we were guided by them and part of the interesting part of the discussion is, they were sort of saying, "Gee, don't focus to much on Pseudomonas because you have a great spectrum across E. coli and Klebsiella also, so do a regular kind of broader-based trial and collect data on all those pathogens, don't limit it to one pathogen. But they are -- it wasn't a -- don't interpret that, the approach we ended up, to be anything with respect to their resistance. That's the plan which -- their resistance to that overall approach of pathogen-specific trial. So they were very open to that. Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division: Great thanks. And I just wanted to kind of get some guidance around the design around the VAP study that you are going through with. Are patients going to be allowed to receive other therapies? I mean, is vancomycin going to be used in combination or is this in more mild to moderate illness where vanc wouldn't be?

So the typical and the guidance for concomitant antibacterial use or prior antibacterial uses, no 24-hour prior antibacterial use. So remember, the initial guidance was no prior antibacterial use for 28 days, now we've got the FDA to a 24-hour period window. So that's the prior antibiotic use. If that's what you mean. Yes, there will be Gram -- I mean, these people, since they're Gram-negative, they'll be allowed to use stuff for Gram-positive if they think they need that coverage. But obviously, those will be for their Gram-positive coverage not for Gram-negative. Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division: Then, I guess, just in terms of that, how do you see kind of the all quarters mortality being affected by staff infection? I mean in more severe cases of VAP. I mean this may be the primary pathogen that results in mortality, correct? I mean...

No. Actually Pseudomonas is the most common mortality driver for bacterial pneumonia. But in fact, again, the size of the trial and the design of the trial, being a non-inferiority, tends to sort of balance those 2 factors. So you will have the same amount of Gram-positive and Gram-negative infections across both treatment arms. So theoretically, and by design, that would sort of wash out, Brian, in the trial.

Your next question comes from the line of Stephen Willey. Stephen D. Willey - Stifel, Nicolaus & Co., Inc., Research Division: Maybe just to ask another question regarding the nosocomial pneumonia study. Would you think that the lack of mITT data that comes out of that Phase III would have any impact in terms of how that drug gets prioritized on formulary? I guess, would there be different pre-authorization requirements on the drug if an ID specialist felt like they didn't have any strain-specific data?

Well, first of all, let me just correct that. We will be collecting all that information. So all the mITT will be collected, so we'll have all the pathogen information, just as we would in any trial. It's just the primary endpoint, the analysis set to drive the primary endpoint will be ITT not mITT, and mITT will be a secondary endpoint. So we'll have every piece of information we would normally always have in this sort of trial. Stephen D. Willey - Stifel, Nicolaus & Co., Inc., Research Division: And so just based on the way that you characterize a reduction in required patients, you would expect that mITT rate would be about 30% in terms of patients that you can get a definitive pathogen sample from?

Yes. On that -- for Gram-negative, that would be about right and about another 30% will have Gram-positives and then the rest indeterminate where you can't get a sample. Stephen D. Willey - Stifel, Nicolaus & Co., Inc., Research Division: Okay. And then maybe if you could just characterize what we might see in the press release regarding the Phase IIIs that are queued up for later this quarter besides, obviously, just kind of a top line, yes we did and no we did.

Yes. The expectation there, Steve, is that we'll provide the material outcome of these studies. Until we actually see the data, and we just have not seen any data yet, it's hard to answer the question specifically. What we'll want to do is walk a fine line to make sure that investors understand, from a materiality standpoint, what the outcome of the studies are, but not to be so disclosive as to compromise the ability to present this data in important infectious disease, pulmonary care meetings -- or critical care meetings, rather. So we'll walk that fine line. It could be as simple as we've hit the primary endpoint, we saw a nice distribution of that pathogens, no major safety signals to something slightly more than that or slightly less than that. But that's sort of how we're thinking about it.

And you do have a follow-up question from the line of Adnan Butt.

Operator, I think just -- we think we can conclude the questions there. We can call Adnan later, if he couldn't get through.

Okay. And at this time, there are no further questions.

Okay. Thanks, everybody, for tuning in this afternoon. We look forward to seeing you, and have a great evening.

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