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Edited Transcript of TTPH earnings conference call or presentation 8-Aug-19 8:30pm GMT

Q2 2019 Tetraphase Pharmaceuticals Inc Earnings Call

WATERTOWN Sep 22, 2019 (Thomson StreetEvents) -- Edited Transcript of Tetraphase Pharmaceuticals Inc earnings conference call or presentation Thursday, August 8, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Christopher Watt

Tetraphase Pharmaceuticals, Inc. - SVP of Finance

* Larry G. Edwards

Tetraphase Pharmaceuticals, Inc. - CEO, President & Director

* Maria D. Stahl

Tetraphase Pharmaceuticals, Inc. - Chief Business Officer, Senior VP & General Counsel

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Conference Call Participants

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* Wing Cheung Yip

H.C. Wainwright & Co, LLC, Research Division - Research Analyst

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Presentation

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Operator [1]

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Good afternoon, ladies and gentlemen, and welcome to the Tetraphase Pharmaceuticals Second Quarter 2019 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

I will now turn the call over to Maria Stahl, Chief Business Officer.

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Maria D. Stahl, Tetraphase Pharmaceuticals, Inc. - Chief Business Officer, Senior VP & General Counsel [2]

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Thank you. Good afternoon, and thank you for joining us today. With me on the call are Larry Edwards, President and CEO; and Chris Watt, Senior Vice President of Finance. On today's call, Larry will discuss recent developments and will provide an update on the XERAVA launch. Chris will provide an overview on our second quarter 2019 financial results and Larry will conclude and open the call to questions.

Before we begin our formal comments, 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 this information in the future.

I would now like to turn the call over to Larry Edwards.

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Larry G. Edwards, Tetraphase Pharmaceuticals, Inc. - CEO, President & Director [3]

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Thank you, Maria, and good afternoon, everyone. Thank you for joining us for our call today. It's an honor to be leading Tetraphase at such a critical time and to be addressing our shareholders publicly for the first time as the company's newly appointed CEO. With our new streamlined commercial focus, the Board of Directors and my predecessor, Guy MacDonald, recently made the decision to appoint me to President and CEO, effective August 1. It's a privilege to be leading the company and working with such a driven team, and I'm committed to delivering on our mission to make XERAVA accessible to patients on a global level.

As you know, the second quarter was an important one for Tetraphase as we made critical decision to undertake a corporate reorganization aimed to maximize the commercial opportunity of XERAVA. XERAVA is a well-differentiated antibiotic that has a broad spectrum of coverage and has a very reasonable and appropriate price point. As antibiotic resistance rate continued to increase and inappropriate initial empiric therapy continued to be a problem, we expect XERAVA to become an increasingly important component of the antibiotic treatment arsenal for complicated intra-abdominal infection. With our newly focused organization, we believe we can continue to execute a successful launch, which remains our #1 priority.

Before we dive into an update on XERAVA launch, I'd like to briefly reiterate some of the details of our recent reorganization, which we implemented back in June. The goal was to enable the company to focus all of its resources on the commercial success of XERAVA, and it was comprised of the elimination of our internal resource functions as well as 20% reduction in the workforce and several management changes. Once again, we would like to recognize that Tetraphase owes many of its innovations, including the discovery of XERAVA, TP-271, TP-6076, TP-2846 to its foundational chemistry platform, and we thank all the current and former employees for their dedication and commitment over the years. We are now exploring out-licensing opportunities for our innovative early-stage antibiotics in oncology portfolio. While we focus our efforts on XERAVA, we continue to believe in the potential of these assets, including TP-2846, which generated compelling early preclinical data for potential use at the treatment for acute myeloid leukemia and potential solid tumors. We look forward to ongoing strategic discussions to find the best partner to further develop these compounds.

Turning to the commercial update for XERAVA. I'm pleased to say that our sales force continues to make significant progress with prescribing physicians across the U.S. In the second quarter, XERAVA's net revenues grew 133% from first quarter of 2019 to over $800,000, which demonstrates a consistent doubling of revenues quarter-over-quarter. We're encouraged by the steady growth and the positive feedback we continue to receive from health care providers, who not only value the clinical benefits of the XERAVA, but also appreciate our appropriate empiric pricing strategy. Many physicians applaud XERAVA's broad label and high-clinical cure rates in patients with MDR pathogens, including ESBLs, Acinetobacter, MRSA, VRE and polymicrobial infection. Physicians also feel 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.

Most physicians believe that XERAVA is a logical alternative to beta-lactams for patients with complicated intra-abdominal infections. Our launch execution strategy, as we've outlined in previous quarters, is comprised of 2 phases. The first was targeting Tier 1 accounts, which are the highest institutional users of antibiotics defined by days of therapy and represent approximately 60% of the gram-negative market. And the second is focusing on Tier 2 accounts, which constitutes approximately 30% of the gram-negative market. We accomplished our goal of reaching Tier 1 accounts during the first quarter of launch and all Tier 2 accounts by the end of first quarter of 2019. With this breadth of coverage, we continue to see impressive reorder rates of greater than 50% for XERAVA as of the end of the second quarter, with reorder rate being as high as 65% within our Tier 1 account segment. This scope of coverage and continued frequent engagement with top-tier accounts delivered impressive new customer growth, which equated to about 20% month-over-month growth during the second quarter, with over 150 new customer orderings in the second quarter. The recent growth of our customer base combined with high reorder rates signal a shift from steady progress to increased traction. Our goal now is to continue expanding our customer base and maintain progress with returning customers. Securing inclusion on hospital formularies is another significant component of our launch strategy. We have a 99.7% formulary acceptance rate at our key target institutions. We're also pleased to report that the second quarter of 2019 had the most Tier 1 and Tier 2 formulary wins to date, and more impressively, we surpassed the goal of being available at 400 institutions by midyear. XERAVA is now available at more than 500 institutions and there are approximately 300 formulary reviews pending or planned to take place by end of fourth quarter. We believe some of the success is due to adding a team of 3 strategic market access executives to help drive formulary acceptance at the C-level as well as key integrated delivery networks and larger infusion centers. While our regional business directors and regional account managers continue to focus on the ground level with IV physicians, clinical pharmacists, critical care intensivists, hospitalists and surgeons.

To give you an idea of the initial XERAVA usage by formulary status, as of the end of second quarter, 19% of our sales came from off-formulary accounts, 25% from pending formulary review accounts and then 56% from formulary -- on-formulary and available with or without restriction. The proportion of our sales is steadily trending more towards accounts that have XERAVA secured on formulary. Our goal is to continue to generate demand for XERAVA, pull-through formulary wins and bring on new accounts.

During the second quarter, XERAVA usage has been the strongest in the in-patient setting, which was responsible for 64% of our sales, while the home health setting is responsible for 25%. Beyond the inpatient and the home health setting, long-term care facilities and clinics drove approximately 11% of our growth. We continue to see XERAVA being used as a replacement for carbapenems 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 who have additional co-morbidities. We also note that XERAVA does not require dose adjustments for renal impairment, which is being recognized as a key factor for usage by physicians since many ICU and early patients have renal insufficiencies. In terms of patient usage, through 37 weeks of launch, XERAVA has accumulated anywhere from 3 to 10x more patients days of therapy as well as more units sold than any recent IV hospital antibiotic launch. Behind the increased adoption of XERAVA is a dedicated -- is the dedication and persistence of our tenured field sales force that continue to focus on Tier 1 and Tier 2 institutions as well as key infusion centers, educating health care professionals and providing tools that show the benefits of XERAVA for patients. An important point I'd like to draw your attention to is, just this week, the U.S. government agency Centers for Medicare and Medicaid Services, or CMS, announced several significant changes to the hospital antibiotic reimbursement, effective October 1, 2019. The change is a part of a rule known as the Inpatient Prospective Payment System full year 2020 final rule, which should help level the playing field so that clinicians can choose the most appropriate antibiotics for their hospitalized patients without fear of hurting the hospital finances. We hope it'll be additional incentive for clinicians to consider XERAVA when treating patients. There is 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 intra-abdominal infections are beta-lactams and resistance continues to increase due to selective pressures put on this class. With XERAVA, healthcare professionals now have another option. We believe the launch is trending in the right direction, from formulary acceptances to formulary review scheduled, to reorder rates, to patient days of therapy, all continue to be on an upward trajectory, with anticipated revenue to mirror this trajectory as additional formularies are secured and as our sales force converts physician engagement into XERAVA usage. Based on the directional indicators thus far, we believe our strategy of targeting empiric usage for XERAVA is working, but it will continue to take time. We look forward to continuing to update you as the launch progresses.

With that, I'll turn the call over to Chris to go through the financials in more detail.

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Christopher Watt, Tetraphase Pharmaceuticals, Inc. - SVP of Finance [4]

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Thanks, Larry. As of June 30, 2019, Tetraphase had cash and cash equivalents of $71 million and 54.3 million shares outstanding. The company expects that its cash and cash equivalents as well as expected revenue will be sufficient to fund operations into the middle of the third quarter of 2020. As Larry mentioned, a reduction in force was supplemented as part of our recent corporate reorganization, and this along with our other cost-saving efforts will result in an approximate $8.2 million reduction in net cash required for operating activities on an annualized basis. We substantially completed the reorganization and will incur approximately $2.4 million of pretax charges for severance and other costs. Another cost-saving item worth noting from Q2 is that we also received approval for the supplemental new drug application from the FDA for our new manufacturing facility for XERAVA in Greenville, South Carolina, underscoring our commitment to XERAVA, increasing our manufacturing capabilities and reducing our cost of goods.

For the second quarter of 2019, Tetraphase reported a net loss of $22.9 million or $0.42 per share compared to a net loss of $9.5 million or $0.18 per share for the same period in 2018. Total revenues were $1 million for the second quarter of 2019 compared to $11.6 million for the same period in 2018. Total revenues for the second quarter of 2019 consisted of XERAVA product revenue of $0.8 million as well as government contract revenue of $0.2 million. The decrease in total revenues for the second quarter of 2019 compared to the same prior year period was primarily due to both a decrease in revenue from our collaboration with Everest Medicines and government revenue, offset in part by XERAVA revenue. Research and development or R&D expenses for the second quarter of 2019 were $8.1 million compared to $14.4 million for the same period in 2018. The decrease in R&D expenses for the second quarter compared to the same prior year period was primarily due to a decrease in activity across all of our pipeline programs versus the prior year, and lower license and milestone payments to Harvard University versus those that occurred in the second quarter of 2018. Selling, general and administrative, or SG&A, expenses for the second quarter of 2019 were $15.1 million compared to $7.2 million for the same period in 2018. This increase in SG&A expenses for the second quarter compared to the same prior year period was primarily due to an increase in commercial related expenses for XERAVA. Additional details on our financial performance for the second quarter may be found in our press release issued earlier today.

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

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Larry G. Edwards, Tetraphase Pharmaceuticals, Inc. - CEO, President & Director [5]

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Thanks, Chris. So in closing, we're pleased to see the key XERAVA launch metrics continue to trend in the right direction and with the recent reorganization, we know we have the right structure and strategy in place to enable a successful commercial launch of XERAVA. As I mentioned in the beginning of the call, there is a clear unmet need and a significant market opportunity for XERAVA. We are all working diligently to reach the goal of bringing this important new antibiotic to the patients in need. 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?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Ed Arce from H.C. Wainwright.

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Wing Cheung Yip, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [2]

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This is Thomas Yip asking a couple of questions for Ed. So first, regarding the 154 new ordering customers in second quarter, approximately what percentage growth does that represent from 1Q '19 numbers?

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Larry G. Edwards, Tetraphase Pharmaceuticals, Inc. - CEO, President & Director [3]

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Percent of growth is probably about 40% of our growth, so we still have very high reorder rates, so we continue to have the reorder rates higher than 50%. So that's still driving a lot of the growth that we have in the product.

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Wing Cheung Yip, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [4]

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Okay. And then speaking of the reorder rate amongst the 50% customers who reorder, approximately what portion have reordered more than once?

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Larry G. Edwards, Tetraphase Pharmaceuticals, Inc. - CEO, President & Director [5]

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So the question is, how many of the reorder rates are more than once?

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Wing Cheung Yip, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [6]

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Yes.

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Larry G. Edwards, Tetraphase Pharmaceuticals, Inc. - CEO, President & Director [7]

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Yes. So the vast majority of what we see are most institutions are ordering anywhere from 3 to 5x and they go all the way out to on a weekly basis. So typically what we're finding is once a hospital orders, we continue to have -- as I mentioned with our Tier 1, which are the larger institutions, have a 55% reorder rate. So we're finding with the larger institutions, once they start using it, they continue to use it.

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Wing Cheung Yip, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [8]

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Okay. That sounds good. And then regarding the new formulary reviews for the rest of the year, can you go over what are some of the major factors that can drive success in those reviews?

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Larry G. Edwards, Tetraphase Pharmaceuticals, Inc. - CEO, President & Director [9]

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I think a lot of it is -- the ones that typically -- now that we're 37-plus weeks out, what -- some of the driving probably important behind those are ones that want to see usage. So they're not the early adopters. So they want to -- what hospitals in the area have added at the formulary. So I think some of it is pull-through and some of the ones we currently have formulary on. Also some of it is testing and validation. So now that we have multiple options from a testing perspective, that's a key piece. And I think lastly then probably one of the key pieces is getting things integrated into the physician ordering system. So a lot of them -- once they add something to formulary, they also then have to add it into -- dependent upon what their CPOE is, it could be Cerner, Epic, whatever. That's another key piece of ensuring addition to formulary, but really after the formulary pull-through.

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Wing Cheung Yip, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [10]

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Congratulations on the progress with XERAVA.

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Larry G. Edwards, Tetraphase Pharmaceuticals, Inc. - CEO, President & Director [11]

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Thank you. Appreciate it.

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Operator [12]

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(Operator Instructions) I am showing no further questions at this time. That does conclude our conference for today. Thank you for your participation in today's conference. You may now disconnect at this time.