Paratek Pharmaceuticals' (PRTK) CEO Michael Bigham on Q2 2016 Results - Earnings Call Transcript

Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK)

Q2 2016 Results Earnings Conference Call

August 4, 2016, 08:30 AM ET


Paul Arndt - Managing Director, Communications, LifeSci Advisors

Michael Bigham - Chief Executive Officer and Chairman of the Board

Evan Loh - President, Chief Medical Officer and Director

Doug Pagán - Chief Financial Officer

Adam Woodrow - Vice President and Chief Commercial Officer


Brandon Folkes - Guggenheim Partners

Robert Hazlett - Ladenburg Thalmann

Tim Chiang - BTIG Research

Jeffrey Lin - Leerink Partners

Chiara Russo - Cantor Fitzgerald


Greetings and welcome to the Paratek Pharma second quarter 2016 financial results. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Paul Arndt, Managing Director, LifeSci Advisors. Please go ahead, sir.

Paul Arndt

Thank you, Stacy. And good morning. My name is Paul Arndt, Managing Director, LifeSci Advisors, Paratek’s Investor Relations firm. And welcome to Paratek’s second quarter 2016 update and earnings conference call.

A press release with the company's second quarter financial results was issued earlier this morning and can be found at

The agenda for today’s call is as follow. Michael Bigham, Chairman and Chief Executive Officer of the Board, will provide an overview of the company’s progress so far this year and near-term plans for the coming quarter. Dr. Evan Loh, President and Chief Medical Officer and Director, will review the company's clinical programs. He will provide an update on the Phase III registration studies for sleep compound, omadacycline. Doug Pagán, Chief Financial Officer, will review the financials for the second quarter. Mike will then make brief closing remarks and open the call to question-and-answers. Adam Woodrow, Chief Commercial Officer, will also be available for questions.

Before we begin, I'd like to remind you that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. The words anticipate, plan, potential, expect, will and other words denoting future events identify statements as forward-looking statements.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various risk factors, including those disclosed in our press release today and in the risk factors section of our Form 10-K filed with the SEC on March 9, 2016.

In addition, any forward-looking statements represent our views only as of today, Thursday, August 4, and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change.

Now, I’ll turn the call over to Michael Bigham.

Michael Bigham

Thank you, Paul. Good morning and thank all of you for joining our second quarter earnings call and corporate update this morning. Over the past few months, we have continued our momentum following our announcement in June of the positive topline data from our successful Phase III registration study of IV to once-daily oral omadacycline for acute bacterial skin and skin structure infections.

As we shared with you at the time, the success of this registration study represents an important step towards the potential approval and commercialization of omadacycline. As you may recall, the study met the FDA and EMA pre-specified primary endpoints for efficacy as well as demonstrated a favorable safety and tolerability profile comparable to that of linezolid, which served as the comparator in the study.

We also continue to make significant progress in advancing our Phase III study, which is evaluating omadacycline for the treatment of patients with community-acquired bacterial pneumonia. We continue to expect to announce topline data from this study as early as the end of the third quarter 2017. As you will recall, we are actively working towards the initiation of our oral-only Phase III study of omadacycline in acute bacterial skin and skin structure infections. We plan to initiate enrollment for this study this month.

Building on the results of our recently completed study of IV-to-once-daily oral omadacycline for the treatment of skin infections, this new Phase III study is designed to create the opportunity for an oral-only indication at launch. Oral-only indications offer several opportunities for value creation. These include the ability to promote in the community setting which is the largest market opportunity for a well-tolerated, broad-spectrum, once-daily oral antibiotic with activity against MRSA. Research suggests that in the US alone, a full 25% to 30% of community-acquired infections are resistant to MRSA, which suggests a significant unmet medical need. An oral-only indication at launch can increase significantly the net present value of omadacycline, thus enhancing its value to Paratek as well as to potential partners.

An oral-only pivotal study in skin infection also provides the added advantage of solidifying the EU regulatory path to approval based upon the scientific advice feedback that Paratek received last year from the CHMP. We believe this oral-only registration study has the potential to enroll quickly, with topline data being available as early as the second quarter of 2017.

Also notable this quarter was the successful completion of a common stock offering, net proceeds of which were $59.3 million. We will use these proceeds, together with our existing capital resources, to fund several important activities to advance omadacycline to the anticipated NDA filing in the first half of 2018, including our planned clinical studies of omadacycline, including the oral-only Phase III study of omadacycline for the treatment of skin infections, and activities to support an NDA submission.

This NDA will request approval for two indications at launch, one for the treatment of community-acquired bacterial pneumonia as well as one for the treatment of skin infections which will include an oral-only dosing regimen for skin. Our activities will also support the manufacture of registration and validation batches.

Overall, we enjoyed a very active and productive second quarter. We continue to execute against our plan in a disciplined manner with the goal of continuing to deliver upon our commitments. Most importantly, we have demonstrated the significant clinical potential of omadacycline with the announcement of the positive Phase III study topline data from our IV-to-once-daily oral skin registration study.

We're pleased with the progress to-date and remain committed to working in earnest throughout the remainder of this year and beyond to advance omadacycline to potential commercialization.

With that, I will now turn the call over to Evan to discuss our clinical highlights from this quarter. Evan?

Evan Loh

Thank you, Michael. Good morning, everyone. We're making great progress with our Phase III registration studies with omadacycline. As Michael mentioned, we are delighted with the positive result topline results of our IV-to-once-daily oral skin infection study. We are now working on analyzing the full data set. The more time that we spend with the data, the more impressed we are with the consistency of the efficacy and safety data.

One of our priorities for the upcoming months will be preparing to present the broader Phase III data at an upcoming medical congress with a view toward submitting these important results for publication in a peer-reviewed journal as soon as possible.

It is our expectation that the full data set will continue to reinforce the robust efficacy, safety and tolerability profile of omadacycline that we observed in the top line data set that we shared with you in June.

Our study of omadacycline in pneumonia continues to progress according to plan. Enrollment remains consistent with our guidance. The topline data will be available as early as the third quarter of 2017.

A second meeting of the Drug Safety Monitoring Board has now been conducted, with the resulting guidance that Paratek continue enrollment in the study as planned without changes to the protocol.

As you heard from Michael, we are excited about the planned initiation of our oral-only skin study later this month for a number of reasons. The design of this study is similar to our completed IV-to-once-daily oral skin study. The study will enroll approximately 700 patients randomized to either once-daily oral omadacycline or to twice-daily oral linezolid.

Similar to our successfully completed Phase III trial, the primary endpoint for this study is the early clinical response, assessed 42 to 72 hours following randomization. The study will also assess the key secondary endpoint of post-treatment evaluation of cure or failure, which, as a reminder, is the primary endpoint for the European assessment of efficacy in the modified ITT population. In May, we received agreement from the FDA on the skin trial design, including the primary and secondary endpoints patient population and comparative.

Based upon our recent experience with our successful IV-to-once-daily oral skin study and the lack of a hospitalization phase in this oral-only study, we expect topline data as early as the second quarter of 2017.

As a reminder, our oral formulation is bioequivalent to our IV formulation, with similar pharmacokinetic characteristics. Importantly, we recently completed a Phase I pharmacokinetic study in normal volunteers, which demonstrated that a once-daily oral dosing regimen results in a steady-state AUC that replicates what we observed in the IV-only loading regimen that we used in our successful Phase III IV-to-once-daily oral skin study.

Enrollment in our Phase Ib study in urinary tract infections is almost complete. In the second quarter, we announced that topline data from this study is now expected to be available as early as the fourth quarter of this year, earlier than previously anticipated. As a reminder, this is a pharmacokinetic study in patients with uncomplicated UTI, evaluating once-daily IV and oral-only regimens. The dosing duration will be for five days in subjects with uncomplicated UTI [indiscernible].

The PK data in both serum and urine will enable determination of AUCs to guide our strategic decisions about which subtypes of UTI should be considered as we progress omadacycline into Phase II. Obviously, the decision to enter omadacycline into Phase II for UTI will depend upon whether we believe that the serum and urine levels are sufficiently above the MIC90 for the most common urinary pathogens, which is E. coli such that clinical success could be projected. We look forward to sharing these data with you at an upcoming scientific congress.

We believe that UTI represents one of the three largest segments of community-acquired infections and one where there is a significant unmet medical need for a new well-tolerated, once-daily oral antibiotic.

The need for a new therapeutic agent has particular urgency now that FDA has just last week issued an expanded black box warning to prohibit the use of quinolone for sinusitis, chronic bronchitis and uncomplicated UTI, unless there is absolutely no other viable antibiotic options.

We also believe that there will be spillover effects that will impact the use of quinolone in community-acquired bacterial pneumonia. We are currently conducting primary research to be able to further define these new opportunities to address the unmet needs in both UTI and community-acquired bacterial pneumonia.

Now, Doug will share an update on our financial results for the quarter. Dough?

Doug Pagán

Thank you, Evan. We continue to be in a strong financial position as we advance to late-stage development program for omadacycline. Following our successful financing, the company ended the quarter with $150.4 million in cash, cash equivalents and investment and $19.6 million in debt.

For the quarter ended June 30, 2016, operating expenses were $29.8 million, in line with the previous quarter as we continue to fund our clinical operation and general company operation.

R&D expenses were $22.1 million for the second quarter. The primary drivers for this expense were our Phase III clinical studies in skin and CABP, other Phase I clinical studies for omadacycline, personnel-related expenses, and expenses associated with manufacturing activity. With the initiation of the oral-only skin study, we expect that this level of expenditure will continue through the rest of 2016.

G&A expenses were $7.6 million for the second quarter. The bulk of these expenses were related to professional services, legal, accounting, audit and personnel-related expenses.

As Michael mentioned, the company completed a follow-on equity offering, resulting in net proceeds of $59.3 million. This influx of cash, together with our current financial resources, including an expected drawdown of the $20 million available under our existing deadline, has extended our projected cash runway. Based on current assumption, our expectation is that the company's cash, cash equivalents, marketable securities and available debt line will fund operations through the omadacycline NDA filing, which we expect to occur in the first half of 2018.

And now, I’ll turn the call back over to Michael to close. Michael?

Michael Bigham

Thank you, Doug. This is an exciting time at Paratek, a time when the many years of discovery and development are now coming to fruition. The positive topline data we announced in June for our Phase III registration study in skin demonstrate clearly the clinical potential for omadacycline.

Leveraging that momentum, we have continued to advance our Phase III program more broadly and have also begun to make preliminary preparations for commercialization of omadacycline. With the pending initiation of our Phase III oral-only study in skin this month, as well as data expected from our Phase Ib study in UTI in the fourth quarter of this year, we're proactively exploring the broader clinical opportunities for omadacycline.

With our continued progress to date, we remain on track to file our NDA in the first half of 2018. While we’re proud of the progress we have made to-date, we recognize that much remains to be done. With the positive Phase III study now completed, the goal line is very much within view and our team remains highly motivated.

We’re privileged to be the stewards of the exciting drug candidate that we have been entrusted to develop for patients in need and our team knows well how much potential good omadacycline can do for patients worldwide – to treat terrible infections and, in some cases, even save lives. That motivates us daily. We know that you too appreciate the importance and the potential of the work that we do and we very much appreciate your continued support.

With that, I will now open the call for questions. Operator?

Question-and-Answer Session


Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Louise Chen with Guggenheim. Please proceed.

Brandon Folkes

Hi. It’s Brandon Folkes on for Louise. Congratulations on all the good news during the quarter. I know, Evan, you touched on it, but could you just help us think through what the expansion of the black box warning for quinolone? What does that mean for the market opportunity for omadacycline? And then secondly, are there any positive read-throughs you’re seeing from the skin study that we could see in the Phase III CABP data? Thank you.

Evan Loh

So, Brandon, thank you very much for the question. I think when you take a step back and think about the quinolone space and what that has to do for the market on that opportunities, I think quinolones have been a mainstay of monotherapy for both uncomplicated and complicated urinary tract infection. And when I'm done talking a little bit more, maybe we’ll have Adam also comment on his views on how that [indiscernible] potential marketplace unmet need. But I think that, clearly, for us, when you look at the marketplace where we're focused in terms of the unique positioning of omadacycline as a broad spectrum, oral, well-tolerated, once-daily antibiotic that community-acquired infections will require a broad spectrum agent and that’s a relevant consideration when you think about urinary tract infection. Now that the quinolone has this black box and we do think that there is going to be a knock-on potential spillover effect in pneumonia.

Why don’t I address the second question in terms of the data that we have now and then I'll flip it over to Adam just a little bit more about the market opportunities with quinolones in these indications. To answer your second question, Brandon, with the positive data in skin, I think it's very confirmatory of the PK modeling that we had talked about prior to the data coming out. Specifically, what we had talked about was the fact that based upon our animal models that our AUC to MIC ratio for the most common pathogens that we worry about in the skin infections were somewhere in the range of five times higher than where we needed to be. And the confirmation of the efficacy that we saw, and the robust efficacy not only for the IV phase followed by the oral continuation phase, speaks not only the confirmation of that AUC to MIC, but I just wanted to emphasize that the continued robust efficacy that exceeded 95% in the clinically evaluable posttreatment valuation phase speaks to the robustness of our once-daily oral formulation.

I think if you think about read-through for us with regards to pneumonia, as we said to you before, based upon our animal models, relative to the most common pathogen that you think about in community-acquired pneumonia which is strep pneumoniae, we believe that our current modeling tells us that we are about tenfold higher than where we need to be relative to anticipated efficacy in community-acquired pneumonia. I think we have confirmatory data now from clinical efficacy with regard to skin and now we have that efficacy anticipated for community-acquired pneumonia.

The final thing that I will emphasize that I think is really important here is that this is a compound that’s demonstrated a very robust safety and tolerability profile to-date. We have now over – treated over a thousand patients now through omadacycline with the IV and – the intravenous formulation. As you saw from our most frequent treatment-emergent adverse event table at greater than 3%, we have seen a confirmation of the safety data that we have seen in our prior studies. So we feel very confident about the pneumonia study moving forward. And I think, at this point, maybe I can pivot over to Adam to talk a little bit more about the quinolone in the marketplace in terms of unmet need.

Adam Woodrow

Thanks, Evan. Let’s take the first two indications, the biggest implication for the quinolone changes [indiscernible] community-acquired bacterial pneumonia space, we just recently completed some research. And it’s very clear to us that even though community-acquired bacterial pneumonia is not one of the indications that the FDA has targeted for black box warning, what’s occurring is that patients are pushing back on the use of quinolones in this indication. What we feel is going to happen is, if there are other alternatives after [indiscernible] which is the most common combination for CABP, if there’s a safer [indiscernible] option, then physicians will naturally migrate to those rather than try and explain why they’re being given quinolone which currently is second-line treatment for that other indication. And rightly so because they do work. However, patients will be pushing back. And that’s why we say there’s going to be spillover in that indication.

Now, in the UTI setting, it’s a completely different story. That accounts for literally 50% of the uncomplicated prescriptions in the retail setting today and also a large number of patients are treated with quinolones in the hospital for uncomplicated UTI. No longer is that going to be the case, but that will be a viable option unless, of course, we had absolutely nothing else that can be done. What’s going to happen in these patients is that they’re going to continue to go back to [indiscernible] and other older agents. But in some cases, they’re going to be left with no option but to utilize the quinolones because they may well be the only agent that actually would work. Now, if we can show that we have a viable oral option here, we know that we will become a first-line treatment really quickly in this uncomplicated and potentially dependent on where the product goes in a complicated setting as a replacement for the quinolones. And, clearly, the quinolone challenges and the safety issues are something that we would target as a reason why you might want to use a safe, well-tolerated, once-daily IV or oral option like omadacycline.

Brandon Folkes

If I could just sneak one more in, perhaps just a modeling question, if we look at the R&D spending – thanks for the color with regards to [indiscernible] could you help us think through that just going into 2017?

Doug Pagán

Yes. I guess, broadly speaking, R&D expenses will track with the study. So we talk about the oral-only skin study completing as early as the second quarter and CABP as early as the third quarter. So I would look to a step down in R&D expenditures in both of those studies. I would say, however, we’ll have a continuing operation. We have other Phase Is ongoing. So it won’t come down, obviously, at or near zero. But it will step down accordingly and be more in line with 2015 late spending. We haven't really given more guidance than that. But I think you’ll see the natural progression down and continue to push our cash runway out into the first half of 2017.

Evan Loh


Doug Pagán

I’m sorry, 2018. Thank you, Evan.

Brandon Folkes

Great. That helps. Thank you.


Thank you. Our next question comes from Robert Hazlett with Ladenburg. Please proceed.

Robert Hazlett

Thanks. Thank you for the color of CABP. I appreciate it. I guess my question is with regard to commercial readiness. Now that you have one Phase III in hand with robust data and another one pulling up in the same indication, I guess this is for Adam or maybe for the team, how do you think about when you really start to spool up your commercial readiness activity and when should we be thinking about that from a modeling perspective?

Michael Bigham

Adam, can you address that?

Adam Woodrow

I can take that. That’s a good question. Clearly, we’re still a far way away from commercialization – full commercialization given the current planning for submission and then approval. Full commercialization will start in earnest from about 18 months out. At that point, we’ll start to bring in the commercial leadership team which will include the sales and marketing organization and the market access organization. And as I think I’ve told you before, we’ve not spent a lot of money on this sort of classic marketing imagery in colors that are done by many companies in large organizations. We have spent quite a bit of money on our pricing [ph] and market access. We understand what we need to do there and we are ready to go and we will fine tune that as we get closer. We’re not going to start the active work until about 18 months out, which is when you should start looking at putting heads in. The largest chunk of those will not occur until about a quarter before launch, however, because that’s when we might need to bring the sales force on, which at the moment is somewhere between 50 and ramping up to about 80 in terms of the hospital sales force that we would need. And that will occur in that last quarter prior to launch.

Robert Hazlett

Okay, thank you for the color. Appreciate it. Thanks.


Thank you. Our next question comes from Tim Chiang with BTIG. Please proceed.

Tim Chiang

Hi, thanks. Could you go through the IP for omadacycline again? It seems like – as you get closer and closer to realizing the efficacy and safety profile benefits of omadacycline, I think it’s – I’m trying to get a better understanding of how long your commercial window will be for the product assuming it’s launched in 2019?

Evan Loh

Hi, Tim. It’s Evan. [indiscernible] goes out to 2023 and we project that we will be eligible for patent term extensions that will take us out another five years beyond that, so to 2028. There’s another way that we actually look at our patent term extension horizon, which is that, because we are designated QIDP under the GAIN Act, we have five years of Hatch-Waxman, plus five years of QIDP patent term extensions. But we look at it in a base case at launch plus ten years.

Tim Chiang

And is there anything on the legislative front that you think might happen in the next year or so that would give you even more confidence on the IP position? I know PDUFA and GDUFA are both up for renewal next year, just any thoughts there?

Evan Loh

Yeah. We spend time on Capitol Hill to keep ourselves close to the legislative efforts as well and we work with many other biotech companies in a group called the Antibiotics Working Group in order to actually do education on the Hill to all of our legislatures, both in the House as well in the Senate to understand the continued unmet need. We believe that continued attention by Congress to help create and remove barriers to antibiotic development and help us along will continue to be important both from our efforts, but ultimately for patients who will desperately need these life-saving antibiotics.

If you look at the current calendar year, it’s a little bit complicated given the presidential election, but there are two legislative bills that we are looking at very closely. One is called the LPAT Bill which is part of the 21st Century Cures Act and that is specifically something that Janet Woodcock is extremely passionate about. And what that is is a limited pathway approval focused on serious unmet needs where there are no antibiotic options. Several companies are more in that sector than we are, but we think that that kind of attention and having that bill passed, and we’re hoping that that gets passed this year, will continue to get the public attention on this particular sector.

In addition to that, there is a bill called the DISARM Act that is currently in Hatch's Finance Committee and we were recently on the Hill in the last two weeks and they are continuing to push that forward to get an overall CBO score that will allow there to be a legislative proposal that would allow this DISARM Act to propose a separate antibiotic payment scheme that is separate from the current ERG’s payment system. And having a separate ERG – separate payment system for antibiotics alone, I think, would be a real momentum builder for the sector as well.

We don’t see anything else on the horizon with regards to patent term extension other than what’s already in place through the GAIN Act. But we believe that those two bills are continuing to move through both the House and the Senate and we’re hoping that at least one of them – we think LPAT is probably a little bit more near-term pre-election, but we’re still hopeful that the DISARM Act could see the light of day before the end of this current administration.

Tim Chiang

Okay, great. Thanks a lot. Thanks, Evan.

Evan Loh

Thanks, Tim.


Thank you. Our next question comes from Jeffrey Lin with Leerink. Please proceed.

Jeffrey Lin

Hi, guys. Congratulations on the quarter. And thanks for taking my call – or question. So I recall in an earlier conference call that you had suggested looking at higher doses [indiscernible] study. Could you perhaps give us a little color and granularity on that? And if you do use higher doses, how does that factor into your thoughts in regard to the oral-only study and IV-to-oral?

Michael Bigham

Just so I understand the last part of the question, you’re specifically referencing the oral-only skin study. Is that right?

Jeffrey Lin


Michael Bigham

Yeah. So I will take the oral skin study first and then I’ll talk about the UTI Phase I study that we’re looking at as well. From a background perspective, what’s important for us is to always do – be able to achieve the steady-state AUC that we’ve seen now in our IV to oral successful Phase III skin study. And we’ve actually now settled on a dosing regimen from an oral once-daily loading perspective for skin that actually replicates the steady-state AUC at the end of day two that we are actually able to achieve with our IV loading dose. And so, we are very confident that we actually have the right dosing regimen there. And we have seen that the oral dose formulation continues to perform extremely well from a safety and a tolerability perspective.

When we look at the urinary tract setting because the pathogen mix is somewhat different than the skin setting where you have a gram-negative, specifically E. coli that has an MIC90 of what we’ve now recently reported in our March ECCMID poster of 2 µg per mL. Higher doses, we think, in the higher levels of concentration of omadacycline in the urine will facilitate our confidence in terms of being successful.

So as we looked at our Phase I studies, we’ve actually looked at higher doses of our oral formulation and we’re confident that these doses will allow us to be able to provide guidance to ourselves initially and then open the link [ph] you all as well. We have achieved a ratio of AUC that is substantially greater than the MIC90 that allow us to move this compound into Phase II. As a reminder, this compound is very different than the glycylcycline class of tetracyclines that I’m very familiar with my history with [indiscernible].

One of the big features that I think is very, very different is, number one, it’s a compound that’s not metabolized; and number two, it is robustly cleared in the urine; and three, it has extremely low protein binding. And I think the low protein binding allows us to understand why we have – we anticipate the robust levels of omadacycline in the urine which is unmetabolized and unchanged from that parent compound. The data that we have reported before is that 40% of the orally absorbed dose of omadacycline is actually cleared in the urine. And so, at this point, we think based upon all of those data that it makes sense for us to explore urinary tract infection, given the unmet need now that has been created in the sector because of the black box warning with quinolone. We are very excited about being able to see these data before the end of the year and be able to give you guidance as to where we’re actually going to go with regards to the oral dosing.

But the goal here is to have an oral-only, once-daily dosing regimen that will allow patients to be successful – to allow omadacycline to be successful in curing those infections.

Jeffrey Lin

All right, thanks for the color.

Evan Loh

Thanks, Jeff.


Thank you. Our next question comes from Chiara Russo with Cantor. Please proceed.

Chiara Russo

Yeah. Hey, guys. Thanks for taking the question. Just some quick ones. I’m just curious if you have any sort of additional color as to the staff enrollment rate of the UTI study. What, kind of, do you think, would have drove that? And then, I have two short questions after that.

Evan Loh

Hi, Chiara. It’s Evan. We were surprised by the exuberant enrollment. I think that what’s nice about our compound is that, over time, once people continue to see permissive safety and tolerability data and as they see patients actually doing well during the study in terms of, again, safety and tolerability, I think the threshold and enthusiasm of investigators to actually bring patients to the trial I think goes up tremendously. That being said, I think that part of it is a testament to the design of the trial, the fact that the way we set it up logistically is actually amenable to actually good conduct and the collection of high-quality data. And we’re excited that our enrollment is nearly complete and that we’ll be able to report these data before the end of the year.

Chiara Russo

Okay, great. Were these some sort of the same sites that did the IV to oral skin?

Evan Loh

No. We made a commitment to really understand the PK and what we have actually done here is that we have actually gone to specialized inpatient units where individuals are actually domiciled for the duration of treatment. So we have the ability to capture every drop of urine, every blood drop, as well as all the other requisite data that we need to ensure that we have an understanding of the safety and tolerability profile as we explore, as I said in the earlier question, higher doses of omadacycline.

Chiara Russo

Okay, great. Thanks. And then one sort of housekeeping question. I was just curious as to sort of where you expect your share count to be by the end of the year? I’m thinking it’s kind of the 22 million, 23 million. Do I have that correct?

Doug Pagán

Yeah. We are north of 22 million now. Right now, we don’t have any plans to expand that.

Chiara Russo

Okay, okay. Awesome. And lastly, I was kind of curious, you said that there is patient pushback in the community CABP space on quinolones. I don’t think I have ever heard that. It seems like that’s a very highly informed patient population. Kind of curious, is that the case? Is that what we’re looking at here or why would patient pushback on the drug?

Adam Woodrow

Chiara, it’s Adam. I’ll tell you what it is, Chiara, is that, obviously, there is the quinolone announcement from the FDA is something that patients pick up on when they do their Internet searches to find out what they have been put on. And when they then read the long list of the label, they basically say to the physicians, look, if there is anything else you can give me, please give it to me because I don’t want to be taking a quinolone. And the reason they don’t want to take a quinolone is when you look at the list of adverse events, it’s got a very long list of adverse events, many of which seem very unpleasant. And their black box warning is now considerably larger than it was before. It already had tendon rupture and other adverse events in there. But, now, of course, they have included these irreversible neurological toxicities. And so, patients are asking the question to physicians, is there anything that you can give me as an alternative to this?

In the uncomplicated urinary tract infection, the patient doesn’t need to ask that question because the physicians are being directed by the FDA to do something different unless they really, really have to. But, of course, if you’re a patient in an indication like CABP and you are offered a quinolone, you then look it up online, you’re going to see what it says about the adverse event profile of this. And even though you can distinguish the fact that it’s not necessarily an uncomplicated UTI you’re being given it for, you are going to ask that question, is there another alternative and that’s what we’re seeing and that’s what we’re hearing.

Chiara Russo

Okay, alright. No, that’s good color. Great. Thank you, guys. Appreciate that.

Evan Loh

Thanks, Chiara.


Thank you. There are no further questions. I would like to turn the call back over to Michael Bigham for closing comments.

Michael Bigham

Thank you. And thank you all again for your time and interest today. But importantly, I also want to express personal gratitude on behalf of Evan and myself to the broader Paratek team for their daily commitment to the successful development of omadacycline. We often ask our team to go the extra mile and they have always done so willingly. They have much to be proud of and even more to look forward to and we’re both fortunate to be counted amongst such a team.

All of our many activities arise from our well-founded belief in the potential for omadacycline to make a real difference in the treatment of serious infections and, consequently, to make a real difference in the lives of patients in need. This belief motivates us daily.

It is important work. And all the more so at a time when bacteria are aggressively eroding the protective safety barrier that antibiotics represent for all of humankind. It is, in fact, sobering to recall that prior to the development of modern antibiotics, the number one cause of death for human beings was infections. There is arguably no more important class of drug.

We know that you recognize the importance of our work and we very much appreciate your continued support and we look forward to keeping you apprised of our continued progress.

With that, thank you all and goodbye for now.


This concludes today’s teleconference. You may disconnect your lines at this time and thank you for your participation.

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