Athenex, Inc.

Greetings and welcome to the Athenix, Inc. third quarter 2019 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Tim McCarthy, with LifeSci Advisors.

Please go ahead, sir. Good morning, and thank you for joining our conference call as we provide an update on the business, as well as a review of financial results for the third quarter of 2019. The news release detailing the third quarter results crossed the wire earlier this morning and is available on the company's website. A replay of this call will also be archived on the company website. During the course of this conference call, the company will make projections or forward-looking statements regarding future events, including statements about financial and clinical milestones anticipated in fiscal year 2019 and beyond. We encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. You can find our SEC filings in the EDGAR database at sec.gov or in the investor relations section at our website at athenx.com. This morning we are joined by Dr. Johnson Lau, Chief Executive Officer, Mr. Jeff Yorden, Chief Operating Officer, Dr. Rudolph Kwan, Chief Medical Officer, Mr. Randall Zee, Chief Financial Officer, and several other executives who will be available to answer questions after the prepared remarks. With that, I'll turn the call over to Johnson for introductory comments.

Thank you, Tim. Hello and welcome. We have continued to make strong progress across the board, bringing us closer to becoming a fully integrated global pharmaceutical company. For the second time this year, we are pleased to be raising full-year product sales guidance for 2019. We have several major catalysts upcoming, including an oral presentation of Oropraclitaxel and Ensequadar data at the upcoming San Antonio Breast Cancer Meeting and two anticipated end-day findings in early 2020, which we expect to follow with regulatory findings in additional global markets. We are also in a very strong position to advance multiple potentially successful therapies in the future. will have been strategic in building out our operations and managing our resources to maximize the potential commercial opportunity of drug candidates in development. As our broader pipeline continues to advance, we're looking beyond current indications and for ways to get the best labels and marketing outcomes for our products. As we prepare to market our first proprietary oncology drug, Oroplactaxel and Ensequadar, will make significant progress to expand and optimize our commercial infrastructure. We expect to be well prepared to make a significant impact with this product immediately once it's approved. As our Chief Operating Officer, Mr. Jeff Yoden will discuss A major part of our ongoing commercial preparation is to continue raising the profile of our new Afinex Oncology brand and become a recognized commercial player with differentiated products that target cancer. Oropracotexil will become our flagship product to build our global brand upon approval. Currently, we are preparing to discuss the Phase III data with the FDA who previously indicated that this study, if successful, could be adequate as a single comparative trial to support registration of oral Prachetaxel and Enzequeda in the U.S. for metastatic breast cancer. The positive data we reported in August was a major milestone for ePhenX, adding to the strong body of clinical evidence that our oral scuffery platform is working as designed. This significantly de-risked the clinical programs that followed, including oral docetaxel, oral erythrotecan, oral topotecan, and oral erubilin. Based on the successful outcome of the Phase III study, oral placatexel has demonstrated a very strong clinical profile from both efficacy and safety perspectives. The study met its primary endpoint, showing statistically significant improvement in O4 response rate compared to IV Precatexol. There were also strong trends in progression-free survival and O4 survival of oral Precatexol compared to IV Precatexol, as well as a greater proportion of confirmed responders on oral Precatexol with duration of response greater than 150 days versus IV Precatexol. neuropathy was much less frequent with oroprexatexor, which we believe is an important differentiating factor. Importantly, this clinical outcome highlights the potential of our oral chemotherapy pipelines, which we expect to develop for a range of cancers and combination approaches, as part of product lifecycle management. Our second NDA, is for our terminobulin ointment for treating adenine keratosis, for which we report positive phase III top-line results in March this year. We completed pre-ended consultation with the FDA and are in the process of finalizing the submission with an anticipated filing in the first quarter of 2020. Our partner, Emerald, is also preparing to submit the market authorization application in Europe. We and our partner Emerald are very excited to launch this product for patients with actinic keratosis who are in serious need of effective therapy. Under our agreement with Emerald, we are eligible for development and sales milestone payments and commercial royalties. I also want to highlight our ongoing effort to integrate our core functions and capture value across the supply chain. I'm very pleased that Affinex has continued to expand our global capabilities and footprint, both in terms of clinical and manufacturing, for our proprietary products and for our customers around the world, which Jeff will discuss. Our new and larger API plant in China completed construction and is anticipated to commence operation in first half of next year. We have also expanded our global clinical R&D capacity in Europe with the establishment of a subsidiary in the UK, and we are growing the number of trial sites in the region. And we are delighted to report that the acquisition of Seidel Assets in Latin America closed on October 31st. These initiatives have been taken with the goal of enhancing a Phoenix's capacity to conduct clinical studies and support our regional marketing decision process. Competition for patients globally has become fierce. Having a high-quality Latin American clinical operation allows us to draw from a population for clinical development that's been overlooked by traditional big pharma. Moreover, Many of our new colleagues at Seidel were, in fact, trained by U.S. big pharma companies, so they bring strong expertise. Because of this enhanced global infrastructure, we believe we'll be in a position to deliver substantial growth and maximum value over the years to come. On the management front, during the quarter, we announced the appointment of Dr. Daniel Lang as President of Access Ferritics Ltd. to lead the operations of our T-cell immunotherapy platform and also act as the City Director of Corporate Development for Infinex. Dr. Leng was previously the Chief Investment Officer of RS Investments. He has over 25 years of medicine, healthcare investment, as well as leadership and business experience. We're delighted to welcome him and look forward to his leadership and insight Inc. Inc. Inc. Inc. Inc. Inc. Inc. Inc. At this point, we do not intend to comment further on this subject, as we want to put our focus on what really matters, which is our pipeline value, clinical developments, and business progress. I will now turn the call over to our Chief Medical Officer, Dr. Rudolph Kwan, to provide an overview of our clinical programs. Rudolph?