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Tetraphase Pharmaceuticals Inc (TTPH) Q1 2019 Earnings Call Transcript

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Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
Q1 2019 Earnings Call
May. 8, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to the Tetraphase Pharmaceuticals First Quarter Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Ms. Jennifer Viera, Corporate Communications. Go ahead.

Jennifer Viera -- Executive Director of Corporate Communications & Investor Relations

Good afternoon, and thank you for joining us today. With me on the call today are Guy MacDonald, President and Chief Executive Officer; Larry Edwards, Chief Operating Officer; Dr. Larry Tsai, Chief Medical Officer; Chris Watt, Senior Vice President of Finance; and Dr. Jacques Dumas, Chief Scientific Officer. On today's call, Guy will make introductory remarks, highlighting recent corporate developments; Larry Edwards will provide an update on the XERAVA launch; Dr. Larry Tsai will provide an update on our pipeline and conference attendance; and Chris will provide an overview of our first quarter 2019 financial results. Guy will then conclude and open the call to questions.

Before we begin our formal comments, however, let me remind you that during today's conference call, we will be making forward-looking statements that represent the company's intentions, expectations or beliefs concerning future events. These forward-looking statements are qualified by important factors set forth in today's press release and the company's filings with the SEC, which could cause actual results to differ materially from those in such forward-looking statements. Information discussed on today's call is accurate as of today, and we do not necessarily intend to update the specific information in the future.

I would now like to turn the call over to Guy MacDonald. Guy?

Guy Macdonald -- Chief Executive Officer

Thank you, Jennifer, and good afternoon to everyone. Thank you for joining us on today's call. Before I get into our formal remarks, I'd like to acknowledge the recent increased public recognition around the growing threat of antibiotic resistance and the urgent need for new therapies to address multidrug-resistant infections. Despite this growing threat and awareness the number of new treatments in development remains alarmingly small relative to other therapeutic areas. The challenges facing drug developers in this field are clear, and appropriate incentives to remove barriers to development and stimulate innovation in the antibiotic space are needed to improve the treatment paradigm to ensure patients receive the best care for these life-threatening infections. But regardless of potential policy changes or any future incentivization, we already face a critical need for new antibiotics today, and this need is not diminishing, particularly with the growing threat of antibiotic resistance and identification of new so-called superbugs.

This critical need for new antibiotics provides an opportunity for companies like Tetraphase. In brief, we believe we have the right formula to succeed. Our lead product, XERAVA, which we launched in the U.S. late last year is a well-differentiated product with broad labeling that we've priced appropriately and that we expect will become an increasingly important component of the antibiotic treatment arsenal for the complicated intraabdominal infection or cIAI. In addition, we are very conscious of managing our burn rate and have build a small and focused organization to support XERAVA and execute a successful launch, which remains our highest priority in 2019. I'm pleased to say that Tetraphase had a productive start to 2019 following XERAVA's introduction last October. Our sales forces continue to make significant progress with top prescribing physicians across the U.S., and we continue to receive positive feedback.

At the recent European Congress for Clinical Microbiology and Infectious Diseases, or ECCMID, in Amsterdam, our team met with many infectious disease doctors and thought leaders who not only value the clinical benefits of XERAVA, but also appreciate our pricing strategy. Clinically, the infectious disease or ID doctors especially value XERAVA's broad spectrum of coverage and high clinical cure rates in patients with polymicrobial complicated intraabdominal infections. Regarding XERAVA outside the U.S., we're excited that our partners at Everest Medicine have dosed the first patient in their Phase III clinical trial for eravacycline in China. We're extremely impressed with the rapid progress they're making and value our collaborative relationship with them.

This is an important milestone for Tetraphase as it brings us closer to having this life-saving medicine available to patients who need it in China. Turning to our pipeline, we presented results of our multiple ascending dose study of TP-271 and data on the in vivo efficacy of TP-6076 at ECCMID, which Dr. Tsai will discuss later. We also shared data on our new pipeline candidate, TP-2846, which is in preclinical testing for the treatment of acute myeloid leukemia. While we're still in early days with TP-2846, the data are compelling, and we're very excited. Overall, we've made significant progress in the first quarter and remain committed to executing a successful XERAVA launch.

I'd now like to turn the call over to Larry Edwards. Larry?

Larry G. Edwards -- Chief Operating Officer

Thanks, Guy. Good afternoon to everyone on the call. Today's call represents our first full quarter since launching XERAVA in the United States. For the first quarter, we generated net revenues of $341,000. We remain encouraged by the progress we have made this far and the feedback we're receiving from healthcare providers. As Guy mentioned, we recently returned from ECCMID where many physicians and thought leaders applauded the efficacy of XERAVA, in particular its broad label and high clinical cure rates in patient in multidrug-resistant pathogens, including ESBLs, Acinetobacter, MRSA and VRE. Many physicians feel that the ability to use XERAVA in patients with penicillin and beta lactam allergies is a critical advantage, while others believe the minimal risk of clostridium difficile developing in patients treated with XERAVA is a major asset.

As we've outlined previously, our launch execution strategy comprise of 2 phases: the first targeting Tier 1 accounts, which are the highest institutional users of antibiotics defined by days of therapy and represents around 60% of the gram-negative market; and the second focusing on Tier 2 accounts, which constitutes approximately 30% of the gram-negative market. We have accomplished our goal of reaching all Tier 1 accounts during the first quarter of launch and all Tier 2 accounts by the end of first quarter 2019. With this breadth of coverage, we continue to see an impressive reorder rate of greater than 55% for XERAVA at the end of the first quarter. The scope of coverage and continued frequent engagement with the top-tier accounts delivered impressive new customer growth, which equated to around 45% month-over-month growth during the first quarter. Much of the growth was driven by a very strong month of March in terms of new customer orders, which indicates growing momentum as we continue to increase brand awareness in the first quarter.

The recent growth for customer base combined with high reorder rates through the end of the first quarter signal a shift from steady progress to increased traction. Our goal now is to continue expanding our customer base and to maintain progress with returning customers. Securing an inclusion on hospital formularies is another significant component of our launch strategy. We have 100% formulary acceptance rate at our key target institutions, and XERAVA has been added to 200 formularies so far. We're on track to have 400 hospital formulary reviews completed by midyear, which we expect to translate to revenue growth over time. Of note, 58% of our formulary wins so far are with large integrated delivery networks. We believe some of this success is due to adding a team of 3 strategic market access executives to help drive acceptance at the C suite level with key integrated delivery networks and larger infusion centers, while the regional business directors and regional account managers continue to focus on the ground level with infectious disease physicians, clinical pharmacists, critical care intensivists, hospitalists and surgeons.

To give you an idea of the initial XERAVA usage by formulary status at the end of the first quarter, 40% of our sales came from all formulary accounts, 31% from pending formulary review accounts, 24% from on-formulary with or without restrictions and 5% from all formulary, but available accounts. The proportion of sales is steadily turning more toward accounts that have XERAVA secured on formulary. Our goal is to continue to generate demand for XERAVA, pull through formulary wins and bring on additional new accounts. During the first quarter, XERAVA's usage has been the strongest in the inpatient setting and is responsible for 62% of our sales, while the home health setting is responsible for 29%. Beyond the inpatient and home health setting, longterm care facilities and clinics are driving approximately 9% of the growth. We continue to see XERAVA being used as a replacement for carbapenem and other beta lactams in areas where resistance is high, and in multiple other cases XERAVA is being used for patients who have penicillin allergies or additional comorbidities.

We also note that needing -- not needing to adjust XERAVA for renally impaired is being recognized as a critical factor by physicians as many ICU and elderly patients have renal impairment. In terms of patient usage, through 24 weeks of launch, XERAVA's accumulated 2x to 8x more patient days of therapy as well as more units sold than any recent IV antibiotic launch. We attribute the early adoption of XERAVA to multiple factors. First, we've undertaken substantial steps to provide hospitals with the tools they need to test the suseptibility of XERAVA within their institution. As we reported on previous calls, we now have 3 commercially available antimicrobial suseptibility test. In addition, in April, the FDA cleared the first automated antimicrobial suseptibility testing panel for eravacycline, which is expected to be commercially available for use in Beckman Coulter's MicroScan System in the fourth quarter of 2019.

We can also attribute some of the XERAVA early adoption to the dedication and persistence of our tenured sales team that continue to focus on Tier 1 and 2 institutions, educating healthcare professionals and providing tools that support the benefits of XERAVA for complicated intraabdominal patients. Finally, there is the product itself. There's a clear unmet need for non-beta lactam agents that can cover resistant pathogens and potentially improve patient outcomes. Greater than 80% of antibiotics used to treat complicated intraabdominal infections are beta lactams and resistance continues to increase due to the selective pressures put on this class. With XERAVA, healthcare professionals now have another option.

We believe XERAVA launch is trending in the right direction from formulary acceptances to formulary reviews being scheduled, to reordering rates, to patients days of therapy, all continue to be on an upward trajectory. We anticipate revenue to mirror this as additional formularies are secured, and as our field force converts physician engagement into XERAVA usage. Based on all the directional indicators thus far, we believe our strategy of targeting empiric usage for XERAVA is working, but it will take time. We look forward to continuing to update you as the launch progresses.

With that, I'll now turn the call over to Dr. Larry Tsai.

Larry Tsai -- Chief Medical Officer

Thank you, Larry. It's been a busy time for our medical affairs team. This past quarter, we presented additional data supporting the clinical efficacy of XERAVA as well as the potential of our pipeline in several medical and scientific meetings. In February, we presented data on XERAVA in high-risk subgroups from our 2 Phase III cIAI studies at the Society of Critical Care Medicine. The affected age, APACHE II score, site of infection and presence of baseline bacteremia were examined in this pooled analysis. Data showed XERAVA had comparable efficacy to carbapenems in the higher risk subgroups. More recently, in April at ECCMID, we presented data on XERAVA as well as pipeline candidate TP-271 and TP-6076. Surveillance data from European clinical isolates from 2017 demonstrated XERAVA's in vitro activity against gram-negative and gram-positive bacteria.

Results of the study show that XERAVA was active against 95% to 100% of all gram-positive isolates tested. XERAVA was also highly active against Enterobacteriaceae including ESBL strains and with the most potent antibiotic tested against Acinetobacter baumannii. At ECCMID, we also presented the results from a Phase I randomized placebo-controlled double-blind multiple ascending dose study assessing the safety, tolerability and pharmacokinetics of TP-271, which is in development for the treatment of community-acquired pneumonia and other serious bacterial infections. Data showed multiple intravenous and oral doses of TP-271 achieved high exposures and were well tolerated. Overall, these findings support continued development of both IV and oral formulations of TP-271, and we continue to seek non-dilutive funding to further develop this candidate. Finally at ECCMID, we presented data on the in vivo efficacy of TP-6076 in murine thigh and lung infection models challenged with Acinetobacter baumannii.

As a reminder, TP-6076, a novel, fully synthetic tetracycline antibiotic developed for the treatment of life-threatening bacterial infections has previously demonstrated high in vitro potency against carbapenem-resistant Acinetobacter baumannii or CRAB with an MIC90 value of 0.063 milligrams per liter or 64x the potency of tigecycline, one of the few remaining treatment options for infections caused by this organism. The study showed that TP-6076 was highly effective against Acinetobacter baumannii in vivo in murine thigh and lung infection models. Regarding TP-6076, the Phase I bronchopulmonary disposition study of the compound is ongoing to confirm appropriate therapeutic lung levels to treat infections caused by Acinetobacter baumannii and other multidrug-resistant pathogens. Results of this study, which are expected in the second half of 2019 will inform our future development plan for TP-6076.

We will continue to roll out data at scientific conferences in the coming months and are excited to have 16 abstracts selected for poster presentations at a range of scientific conferences, including the 22nd Annual, Making a Difference in Infectious Disease, or MAD-ID meeting in May, the 2019 Surgical Infection Society, or SIS congress in June, and ASM Microbe 2019 in June. Beyond our antibiotic pipeline, we presented data on TP-2846, which we are developing for the treatment of acute myeloid leukemia or AML at the American Association for Cancer Research Annual Meeting in April. TP-2846 is a direct result from our tetracycline total synthesis platform discovery efforts and represents an exciting first step into a new -- a potential new therapeutic area for us. While it is a new area, our expertise in tetracyclines has a meaningful applicability and relevance. There are decades of research and a large body of literature demonstrating that tetracyclines hold potential of anticancer agents.

We are particularly excited about TP-2846 as it is a novel, potent tetracycline with preclinical activity across multiple in vitro and in vivo cancer models. At AACR, we presented data showing that TP-2846 binds to the mitochondrial ribosome inhibiting protein translation and inducing apoptosis. Mechanistic assays demonstrated changes in protein and gene expression all consistent with disruption of mitochondrial translation. TP-2846 is novel mechanism of action. Disruption of mitochondrial translation has not previously been fully explored clinically for oncology. Currently, we're finishing toxicology studies, and we'll decide on next steps for TP-2846 when we have the data. But for now, we remain very encouraged. Overall, this has been a busy quarter, and we are pleased by the quality and quantity of scientific data we've been able to generate. We look forward to the upcoming data presentations, and we will provide more information as we get closer.

Now I'll turn the call over to Chris to go through our financials in more detail.

Christopher Watt -- Principal Financial & Accounting Officer

Thanks, Larry. As of March 31, 2019, Tetraphase had cash and cash equivalents of $87.6 million and 53.7 million shares outstanding. We expect our cash and cash equivalents as well as expected revenue will be sufficient to fund our operations into the third quarter of 2020. For the first quarter of 2019, Tetraphase reported a net loss of $19.5 million or $0.36 per share compared to a net loss of $21.6 million or $0.42 per share for the same period in 2018. Total revenues were $1.3 million for the first quarter of 2019 compared to $1.9 million for the same period in 2018. Total revenues for the first quarter of 2019 consisted of XERAVA product revenue of $341,000 as well as government contract revenue of $932,000. The decrease in total revenue for the quarter -- of first quarter of 2019 compared to the same prior year period was primarily due to a decrease in government revenue offset in part by the XERAVA revenue.

Research and development or R&D expenses for the first quarter of 2019 were $6.7 million compared to $18.1 million for the same period in 2018. The decrease in R&D expenses for the first quarter compared to the same prior year period was primarily due to lower clinical trial costs associated with IGNITE Phase III clinical trial program, which concluded in the first quarter of 2018 as well as milestone payments to Harvard University that occurred in the first quarter of 2018. Selling, general and administrative or SG&A expenses for the first quarter of 2019 were $13.3 million compared to $5.7 million for the same period in 2018. The decrease in SG&A expenses for the first quarter compared to the same prior year period was primarily due to the increase in commercial-related expenses for XERAVA. Additional details on our financial performance for the first quarter may be found in our press release issued earlier today.

I'll now turn the call over to Guy for closing remarks.

Guy Macdonald -- Chief Executive Officer

Thanks, Chris. In closing, we're pleased to see key XERAVA launch metrics continue to trend in the right direction and remain committed to executing on our business to enable a successful commercial launch of XERAVA in the U.S. As I mentioned at the beginning of the call, there is a clear unmet need and a significant marketing opportunity exists. We're all working diligently to create a sustainable company based on successful commercial asset and a strong and promising pipeline. We're grateful for your support and look forward to providing future updates.

With that, we can now turn the call over for questions. Operator?

Questions and Answers:

Operator

(Operator Instructions) Your first response is from Ted Tenthoff of Piper Jaffray. Please go ahead.

Edward Andrew Tenthoff -- Piper Jaffray -- Analyst

Thank you very much for taking the question guy's, thanks for the update; and Larry, thanks for going through the launch metrics. What's your kind of take to kind of get XERAVA up to a level where it's been used more broadly? Is this a step-by-step function? Is there some data specifically that market needs? Or help us understand sort of what it's going to take to get XERAVA going?

Larry G. Edwards -- Chief Operating Officer

Hey, Ted, this is Larry. Thanks for the question. I think that it really -- some of it is a matter of time. So I mean, if we look at what happened in the first quarter, as I alluded to, really what we saw a big bump was in March. So I think that as we continue to move along, we continue to see nice growth month-over-month. March was a very large month for us. So I think as we continue -- having the representatives now hitting the Tier 1 and the Tier 2 continuing to educate some of the key prescribers and then also having our strategic market access executives out there now, having interactions with some of more of these larger integrated delivery networks. We're starting to see a lot more uptake. So I think that's one of the key catalyst as we continue to moving on. I think beyond that, there's really no additional data. I think it is again just getting physicians used to using the product, and once they start using it, we have seen very high reorder rates. So there seems to be a pretty quick comfort level with it once they start using the compound.

Edward Andrew Tenthoff -- Piper Jaffray -- Analyst

That's really helpful. And then with respect to oncology, what are next steps? What should we expect from that asset?

Guy Macdonald -- Chief Executive Officer

Yes. I think that we presented, as I think you saw some really exciting preclinical data at the end of March. The next step is, we're in the middle of our toxicology studies, and we're waiting to get those completed, which will be in the middle of the year. Then when we get through that hurdle, we'll be happy to share with you the timelines of moving toward IND and beyond that.

Edward Andrew Tenthoff -- Piper Jaffray -- Analyst

Excellent. Look forward to that. Thanks so much guys.

Operator

Thank you. Your next response is from Steven Willey of Stifel.

Ellen Sands -- Stifel -- Analyst

Hi, thanks for taking the question. This is Ellen on for Steve. Just a few on the XERAVA launch, and thanks so far on the color you've provided there. But as the launch has progressed, I'm just wondering, what the patient mix looks like between commercial or government lives covered? Additionally, kind of related to that, has there been any reimbursement issues? And then secondly, I know the 65% reorder rate is a pretty impressive number, but I was wondering, last quarter's reorder rate was around 70%. So I was wondering if you have any thoughts as to what may have driven that decrease between reordering rates?

Larry G. Edwards -- Chief Operating Officer

Yes. So this is Larry again. All good questions. So I'll take them one at a time here. So I think the first one is, looking to see what the payer mix looks like. So right now, I would say probably 95% are commercial payer. Commercial, that meaning either coming in from a third-party payer or a CMS patient. So that's probably our biggest mix right now. We do -- really, there is no reimbursement issues. We have everything set up through FFS or your Federal Supply Schedule, so that's set up. So we also have 340B, all that's set as well. So right now fully accessible from any patient population. But I would say, again, it's probably about 95% on the commercial side. And then moving over to your second question was the reorder rate. So as we would expect and as I mentioned even in our 4Q earnings call, we want to try to keep that reorder rate 50% or above.

So when you start to bring on new accounts, obviously, that's going to dilute some of your reorder rate, so we run this on a quarterly basis. Also in house, we run it on a weekly basis. So we look at that sort of fluctuates on a weekly basis and then we lock it in at the quarter basis. So if you bring on, let's say, very similar to March what we brought on over 40 new customers, that dilutes then what you had in your original database. So that's the only thing that impacts it. So we continue again to have very strong reorder rates, greater than 50% and hopefully we can continue to achieve that as we continue bringing on new customers.

Ellen Sands -- Stifel -- Analyst

Okay. Great.

Operator

Thank you. Your next response is from Edward Nash of SunTrust.

Fang-Ke Huang -- SunTrust -- Analyst

Hey, this is Fang-Ke on for Edward. Just one quick follow-up on the order rates. I think Larry, you have launched multiple products prior to Tetraphase. And just wanted to understand like your prior experience, what's the reordering rate looks like? And how it's compared to XERAVA launch here?

Larry G. Edwards -- Chief Operating Officer

That's a good question. I mean, if I look back, just some of the different things we analog -- use as like an analog is, I won't say products, but we look at -- some that have launched over the last 3 to 4 years, typically in that first year there run anywhere from as low as 10% up to as high as 50%, but I'd say usually it's coming at around 35%, that's why we're really trying to shoot at a greater than 50% reorder rate once you can get a hospital to continue to reordering. Again, typically, it means that it's getting put into a protocol, physicians are comfortable using it, really with the empiric strategy that's something we want to see too. It's because once it starts getting used empirically, you're going to notice that you have more and more reorder rates. That's really why we've kind of set that bar pretty high at 50% or greater.

Fang-Ke Huang -- SunTrust -- Analyst

Okay. Great. And secondly, on -- I think -- you have the experience of launching multiple antibiotics before, and just can you point out to us something that you observed here for XERAVA that give you confidence that over time you're going to see greater adoption and then great breakthrough. Just few things that you observed specifically for XERAVA?

Guy Macdonald -- Chief Executive Officer

Yes, sure. And thanks for the question. I think the one thing that is a little different with this one, and I have launched other very good products in the anti-infective space, this is one of the first launches that I -- we've never really had pushback from institutions or physicians. There's no one that's saying, hey, I really don't see where I'm going to use this product, where I have seen that with other good drugs that we've relaunched, physicians just didn't think that there was a good fit for it. Where at least with XERAVA what we continue to hear unaided is, hey, look this is a great utility drug and we can definitely find an area to use this.

So it's one that I think as you continue to see more and more publications coming out there about overutilization of Pip-Tazo and vanc leading to AKI, AKI requiring dialysis or you have the Marino paper that comes out showing that for patients with ESBL bacteremia that Pip-Tazo's is not a good option as a carbapenem alternative. So as we continue to get more and more into literature, I think people are getting more comfortable and saying, hey maybe we need to go to something other than a beta lactam for some of these ESBLs or other infections.

Fang-Ke Huang -- SunTrust -- Analyst

Great. Thanks so much.

Guy Macdonald -- Chief Executive Officer

You're welcome.

Operator

Thank you. Your next response is from Alan Carr with Needham. Please go ahead.

Joseph Stringer -- Needham -- Analyst

Hi. This is Joe on for Alan. Quick one on the pediatric PK safety trial. Can you give us update on that? And when can we expect results for that?

Larry Tsai -- Chief Medical Officer

Sure. This is Larry Tsai. I'd be happy to answer that question. As you know, for most antibiotics, pediatric development program is a requirement at the time of approval and of course XERAVA is no different from that. I think we previously announced that we have started our pediatric PK study and we're continuing to enroll patients in that study. As you know, traditionally, these are slow studies to enroll. And so we haven't really announced a time line in terms of the completion of that study at this point.

Joseph Stringer -- Needham -- Analyst

Okay. And then a quick one on 2846. Is that something that you would plan to keep in house potentially going forward? And have you -- are you working on other sort of preclinical types of candidates leveraging your platform in that area?

Guy Macdonald -- Chief Executive Officer

Thank you for the question. I think, as I mentioned earlier, the goal right now is to get the toxicology studies finished, then we'll really have the full preclinical profile and our next step then would be to look at filing an IND and I think then beyond that we'll really see whether it makes sense for us to continue to do it ourselves or what value that brings us versus looking at other alternatives. But we're just really excited about the preclinical profile that we have so far with the compound that we've shared some of that data. At this time, we are not looking for any alternatives to 2846. We think that's the best compound that we found coming out of our tetracycline platform and are pleased with what we've done with it so far.

Joseph Stringer -- Needham -- Analyst

Thank you.

Operator

I am showing no further questions at this time. I would like to turn the conference back over to Jennifer Viera.

Jennifer Viera -- Executive Director of Corporate Communications & Investor Relations

Thank you, everyone, for joining today's call. If you have follow-up questions, please reach out to us. Otherwise, have a good evening. Take care.

Operator

Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.

Duration: 30 minutes

Call participants:

Jennifer Viera -- Executive Director of Corporate Communications & Investor Relations

Guy Macdonald -- Chief Executive Officer

Larry G. Edwards -- Chief Operating Officer

Larry Tsai -- Chief Medical Officer

Christopher Watt -- Principal Financial & Accounting Officer

Edward Andrew Tenthoff -- Piper Jaffray -- Analyst

Ellen Sands -- Stifel -- Analyst

Fang-Ke Huang -- SunTrust -- Analyst

Joseph Stringer -- Needham -- Analyst

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