Q1 2021 Theratechnologies Inc Earnings Call
Jeff
Jeff
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Dead dead dead dead. Good morning, ladies and gentlemen, and thank you for standing by welcome to this theratechnologies conference call at this time. All participants are in, Georgia.
Calling the presentation. We will conduct a question-and-answer session and instructions will be provided at that time for you to queue up for questions. If anyone has any difficulties hearing the conference, please press the star key by the zero for operator assistance at any time. I would like to remind everyone that this conference call is being recorded today, April 14th at 8:30 a.m. Eastern time, and I would like to now turn the conference over to the neighbor's a vice president Communications and corporate Affairs Mister Boucher, please go ahead.
Thank you and welcome. Mr. President and chief executive officer of theratechnologies at mistress senior vice president. And Chief Financial Officer will be the speakers on Thursdays. Call me. Open exclusively to financial analyst will follow their presentation before Paul begins his remarks. I've been asked by theratechnologies to read the following message regarding forward-looking statements. I would like to remind everyone that theratechnologies remarks today contain forward-looking statements about its current and future plans expectations and intentions results levels of activity performance goals or achievements or other future events or developments in preparing these forward-looking statements several assumptions will be theratechnologies and they are risks that results actually obtained by the company will differ materially from those statements and the consequence the company cannot guarantee that any forward-looking statement will yep
Gary eyes and you are cautioned not to place undue Reliance on them.
Theratechnologies refers current and potential investors to the forward-looking information section of its Management's discussion and Analysis issue this morning and available at triple double seater, and on editor at triple W. Govt forward-looking statements represent theratechnologies expectations, as of April 14th, Twenty One except as may be required by Securities laws theratechnologies does not undertake any obligation to update any forward-looking statement, whether as a result of new-age information future events, or otherwise, I would not like to turn the conference over to fall.
Thank you, Danny. Good morning everyone and thank you for being with us today. I would like to begin today reflecting in the last 12 months and also give thanks to what the theratechnologies team as a population this time helping to position us for growth in the media and long-term coincidentally have been with theratechnologies for a year now. And in my time here is CEO wage strong head ways towards unlocking the additional potential of the company's commercial and pipeline businesses. I am confident in the Strategic plan that we have mapped out and believe that there are Technologies is at a unique point in its Evolution. We have a tremendous opportunity ahead of us to further strengthen our business.
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Sending our roadmap in motion or the course of the year and demek was also taking hold of the world on a global scale to placing additional and unforeseen challenges in front of us off as a result of Depends a McDouble economies businesses of all sizes in sectors families and individuals were thrusted into operating in a completely different way and we were certainly not immune to this but we're now aligned with the company's Mission and values more than ever which is to bring new treatment options to Health Care Providers and patients by developing and commercializing Innovative Therapies in areas of high unmet need for people living with HIV. This was even more poignant in 2020 as a result of the pandemic.
I am very humbled by what we have achieved. We exited twenty-twenty as a stronger more focus and align organization and have continued that momentum into the age of twenty Twenty-One, even though we're a business has been down into my defend Emmitt. We continue to move forward based on the execution of our strategic roadmap ingrained with the commitment to our stakeholders in the patience and communities that we serve as a result. I believe we have reached an inflection point under him by our Strategic investment in and at least on two critical objectives advancing our clinical development pipeline programs in National Quality in growing our HIV commercial franchise.
With regards to working any cool Pipeline and oncology. We are extremely pleased that our Phase 1 clinical trial is either waiting our lead that I dropped off a 1902 for the treatment of sorta and positive solid tumors commands last month ahead of our Target of time frame in just a few months. We've moved th 1902 through the regulatory initiation process identified and on board clinical sites and completed screenings and those our first patient at March month. We received Fast Track designation from the FDA for a th 1902 and February of this year, which was a remarkable accomplishment today, very few companies have bath and it's fast track designation based on three clinical research and we were excited and feel fortunate to be able to advance our ecology pipeline. So swiftly through our song
Cowen positive technology, we believe that we have developed eh 1902 as a fit-for-purpose peptide drug conjugate that could potentially change the way cancer is treated.
Just a few days ago new positive in equal data on th 1902 or presented at the American Association for cancer research annual meeting. These data demonstrated 16 tumor regression better anti-tumor activity and durability with th 1902 compared to docetaxel alone in all cancer type studies namely Jesus an Oma pancreatic ovarian endometrial colorectal and triple negative breast cancers, the anti-tumor effects of CH 902 also persisted longer post-treatment than with docetaxel alone.
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To demonstrate the positive tumor response and colorectal cancer was particularly remarkable as this is a known hard to treat cancer that normally does not respond to those Excel disciple toxic used with our sort one positive technology to build th 1902 furthermore. These data shows that in all cancers study nutrition was absent after six consecutive treatments with d h 1902 as an equivalent to those of the maximum tolerated those of those effects out.
We believe this is a major advantage of our sort one positive technology as many current cancers are known to cause neutropenia. Even the most recent ABCs off when it increases a patient susceptibility to develop infections and forces them to stop their cancer treatment to avoid this potentially severe side effects.
These new data presented at aacr further support the development of CH 92 in various cancers as well as highlight its broad applicability for the potential treatment bought a home sort in and expressing solid tumors unresponsive to standard therapy. We have contracted with a well-recognized global cro to assist with our faith is one cable trial and plan to collaborate with some of the most influential clinical Center sites in the US including Anderson Cancer Center in Houston, Texas, Gettysburg. And you're in Pennsylvania Sedar is seeing eye Medical Center in LA and Carmen us and your Institute in Detroit, Michigan to name a few thousand more excited for the 14th to bring this Innovative methods of treatment to patients and look forward to providing you with additional updates.
In that are the qualities also has the potential to provide an opportunity to bring an Innovative treatment in an area of high unmet need the initial phase three clinical trials to some morning for the treatment of Nash and stage two or three five roses is on track to begin in the third quarter of the calendar here for the fda's recommendation. We have confirm a date to meet with the agency and discuss the proposed trial design and protocol to prepare for the start of this trial that we're chief medical officer North Christian mess with anything have worked diligently to engage with t a pathologist in the next phase in North America to actively build support for our face to reprogram evaluating to someone in Internet.
We're using the same strategy in Europe to educate ahead of a trial and aligned with the original story agencies given the well as selfish vehicle history and Thursday morning, which is designed to work Upstream to reduce the activation of liver fat that leads to Nash the feedback. We have received from t k o l has been very positive. We have contracted with a global large-scale cro explicit in working with dissenters to execute the trial based on the Insight that we have received from the f d a m s r including a study and we proceed that are in January of this year into support and feedback. We receive from the Google experts in a panic diseases and we're fully confident in our ability to initiate the phase 3 trial on time. It is also important to highlight that we are in a unique and very favorable position entering phase 3 developer.
with the treatment that has a support of ten years of safety data and a predetermined those at the start of the trial combined with an
Intellectual property position that has been further strengthened by a newly issued patents for the treatment of liver disease tesamorelin has a potential to become a best-in-class candidate for did you meet men of the serious and deadly condition we plan to use his reformulation of the morning and our phase 3 trial the f8 formulation as a number of significant improvements over our current effort formulation, which is currently commercialized as egrifta SV for the treatment of HIV Associated lipodystrophy on like the F or the examination is twice as concentrated resulting in a smaller volume of administration and is intended to be presented in a multi-dose vial that can be reconstituted one per week.
In addition to the f8 formulation. We're also developing a multi-dose pen injector to be used with the S8 once approved which is progressing as planned. We believe a multi-zone and formulation of that same presents a number of significant advantages for not only awareness program, but also for current commercial opportunity and hid Associated lipodystrophy as it has a potential to change the way Physicians and patients. Look at the management of this rule fat. We willing to lose the multi-dose pen injector and the intake formulation is the same d l a month which we intend to file with the FDA Journey 2022 and believe both opportunities served as important advancement in the lifecycle management of the subordinate.
We are executing a similar strategy but regardless of which is currently approved for multidrug-resistant hiv-1 in conjunction with our agreement with time and biologics Thursday. We are evaluating to new methods of administration of trogarzo as we build upon the life cycle management of this important therapy as study is underway that a waiting and off the importance Regional trogarzo and the trans expected to be completed in the third quarter of 2020. Once certain Technologies in time is are also planning to evaluate the ninja muscular method the registration for two hours or we are very excited about both of Trials and these new modes of administration having the potential to improve overall patient compliance and improve their sustained quality of my further strengthening our commitment to bring along acting and efficacious are getting option for empty are HIV to patients and a phone number.
We continue to seek unfortunate he's to invest in the lifecycle management are HIV medicines building upon our position is a niche markets. We serve in order to figure support our patient communities for trogarzo. We have been focused on doctor and patient education as our independent Research indicates that clear medical gap guards to understanding the alpha management of a person with MDR HIV enters of unmet medical need and Commercial importance. There is not a higher priority patient population off and then it aside the MVR hid population poses a significant Health concern as for many of these patients. They are no other treatment options left.
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We know from independent market research that the fear majority of these stations and doctors at a high intend to pursue new therapies once their current treatment stops working.
In the US our marketing and Community liaison team have been working to provide resources to patients based on real-world evidence and data that they can be more empowered and educated on their disease additionally. Our teams have conducted patient case studies that provide important insights into the profile of MD or HIV patients and can be used as a Health Resources for each TV. So identify patients and increase MDR HIV disease awareness.
To further our efforts during the first quarter. We conducted a field study to better understand the patient experienced while being treated with regards to this study focused on the understanding access advocacy and support as well as their satisfaction with dozing and the situation and overall treatment the feedback we receive was extraordinary and gratifying the majority of stations expressing a very high satisfaction rate of more than 90% across virtually all aspects of treatment while 93% of patients indicated that they would recommend through Thursday from other people living with HIV of particular notations Express feeling more protected from their disease and optimistic than they have found a treatment that can offer a potentially long-term sustained effect, especially related to the reduction of their viral and improvements in their CD for accounts.
We've taken a similar approach with doctors conducting Outreach to better understand the experience with trogarzo and created resources and data-driven guidelines when form them on how to advance the care of their patients living with HIV.
In Europe. Our team has been working hard to make headways with kol to better inform them of the benefits of trogarzo through advisory meetings and science-based virtual events in addition a building a base of newly identified patients. We continue to work towards obtaining reimbursement for trogarzo into European countries. And if we have created a strong foundation for our sins for when depend image Associated lockdown measures are listed for a egrifta is we we continue to educate doctors and patients that this real fast is a serious medical condition and is more serious than the lifestyle disease in HIV patients better understanding the consequences of visceral fat. They are more likely to explore options for their condition. We recognize that patient activation and profiling is key to Bringing more patience on our therapy to that end. We have launched a digital strategy that proves
Tools to allow both hcp that patients that have more meaningful conversations about treatment options for this serious medical condition. For example, we recently launched a new age enhanced website great egrifta SV that provides tools and resources for HIV patients to help them identify their condition and also connect them with Specialists that can help them overcome the burden of visual fact.
New barriers Still Remains with the COVID-19 pandemic limiting resources in Hospitals and Clinics doctors continue to be overwhelmed by treating COVID-19 patients in many cases infectious disease doctors any GPS have been transferred to serve on the front line to fight thinking it's coded further impeding patient's ability to start treatment with one of our hid medicine. Well first quarter sales were relatively flat year-over-year. We believe that the transfer HIV medicines are moving in the right direction. This can be attributed to the momentum our commercial and medical teams have built to create a stronger base of patients and Physicians support.
Over the last twelve months the prescriber base for both trogarzo and egrifta s z as more than doubled which I believe in education that we are well-positioned for commercial. Well particularly as we emerge from the pandemic the fact that there were in business is not suffer more than it did is a testament or a team adjusting their rapidly to the oil changes that were made during dependent these strategic and marketing initiatives and Commercial changes have now been laid out according to plan through these continue to Thursday. We now have a solid global commercial base that will provide an optimal landscape to grow our anxiety medicines.
It's an alternative for the first quarter results today, please go ahead good morning. Everyone Consolidated revenues for the first quarter of fiscal. Do you want fifteen point four million dollars essentially flat over to one of 20 20 in what is usually our most difficult quarter of the Year. Mostly because of Public public private insurance factors in the United States revenues from egrifta SV were eight point seven million dollars up 2% from the same period last year while unit Sales Catholic you 120 were essentially flat inventory levels that are distributed at the end of the quarter were somewhat lower and this was compensated by our selling price.
Trogarzo revenues were down 6% year-over-year as a result of lower unit sales to Specialty pharmacies compounded by lower inventory levels at the distributor level wage. Although patient retention continues to be quite strong for you patience starts remained below where we think they should be as the US emerges from COVID-19 related lockdowns Thursday. We are a confident this situation will be resolved in the EU. We are seeing having a sales Trends are moving up but it's still early days yet to see a Major Impact from our sales and marketing efforts additionally COVID-19 in the U is still problematic is affecting patients initiation of therapy. Our team in Europe is identifying patients and we are confident that once restrictions related to COVID-19 or east we will see a meaningful flow of patients initiating therapy dog.
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Progressing in the EU reception has been positive.
With this in mind we have laid the groundwork to Growing revenues of the theratechnologies franchise both in the US and EU and expect to see our efforts bear fruit from the Strategic issues.
Cost of sales in q1 2421 was down to five point four million dollars compared to 6.8 million dollars for the same quarter last year decrease is mostly due to higher margins on group. S be compared to Ingres. As well as the lower transfer price for trogarzo given the achievement of a predetermined sales milestone in Q3 last year.
Are the expenses amounted to four point nine million dollars and $221 compared to three point four million dollars for the same quarter last year. This increase is largely due to higher ending in our oncology and Nash programs increases spending in medical and patient education as well as higher medical Affairs initiatives in Europe for three months. And did February 28th 2021 selling expenses were down to six point 1 million dollars compared to 6.3 million dollars for the same period last year off the deep recesses mostly associated with the transfer of resources for marketing to medical education in activities General and administrative expenses, and it's a 3.6 million dollars each one up from 2.6 million in q1 of twenty-twenty. This increase is mainly attributable to the overall increase in business activities dead.
As well as increased activity in Europe in two hundred twenty Twenty-One. We recorded one point four million dollars Finance cost compared to one point three million dollars off your 12020 as previously stated. It has caused comprised of interest on the convertible notes as well as creation expense the first quarter of 21. We recorded a negative ebitda of one point eight million dollars compared to -1 million dollars you 120 the difference is mainly due to hire a net loss during the quarter reflecting the impact of the capital raised during q1 21. We ended the first quarter with a cash and equivalents of $57,000. I will now turn the call back to call for some closing remarks.
Thank you for David as we proceeded to build momentum in 20 21 MB R. I can't stress enough that these are Technologies of today is far from where we were in the past month and we're well positions for future growth in line with our growth efforts is our continued progress to strength in our business with t talent that have a proven track record of being injected and successfully leading organizations and developing and more medicines. This is particularly highlighted by our recent announcements of two new strategic additions to our team. I would like to take this award changing to formally welcome and introduce John Leisure as theratechnologies newly-appointed global commercial officer and Peter Cole as the company's vice president of our u s h i v commercial operation.
Well, John.
Peter bring important capabilities that are needed to bring theratechnologies through our next stage of growth theater experience and Leadership will be integral in enhancing our efforts to grow sales for HIV business in the US. Well, John will need our Global efforts to build our capabilities to be more competitive in HIV and take on the global landscape fog and and oncology. I am very pleased that we were able to attract such down into it and experienced individual with sales and marketing expertise across hid endocrinology and oncology and I look forward to their contributions towards the growth of our commercial assets and the development of our five point.
Additionally, we have added a newly-created function to our commercial organization with the appointment of a head of global manufacturing sourcing and pharmaceutical development to oversee our American and European supply chain procurement Logistics and pharmaceutical development operations on the Capital Market site the recent offering we closed in January as a former does the resources to further support our strategy to enhance? Our commercial initiatives are in development and working capital needs additionally. We are devoting more choices to enhance our Outreach to the investment community and the deal has allowed us to cultivate new institutional investors who are focused on life sciences and support our strategy.
I am absolutely confident that theratechnologies now has the resources talent and infrastructure needed to succeed and we're committed to doing so to drive future sustainable growth and value creation for all our stakeholders. Thank you for your time today. And with that we will now open the call to take your questions.
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Well, thank you very much operator. Is there any question that this time we will conclude this morning's investor conference call. Thank you very much for being with us this morning. Have a very good day, bye-bye.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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