Spectrum Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to the Spectrum Pharmaceuticals third quarter 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Grabo, Executive Vice President and Chief Business Officer. Please go ahead.

Thank you, operator. Welcome to Spectrum Pharmaceuticals' third quarter 2022 earnings call. With me on today's call are Spectrum's President and Chief Executive Officer, Tom Riga, Executive Vice President and Chief Medical Officer, Dr. Francois Lebel, Executive Vice President and Chief Financial Officer, Nora Brennan, and Senior Vice President, Sales and Marketing, Erin Miller. Earlier today, Spectrum issued a press release detailing its financial results for the three-month ended September 30th, 2022. This press release and a webcast of this call can be accessed through the Investor Relations section of the Spectrum website at sppirx.com. Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements we will make this afternoon. These statements are not guarantees of future performance, and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. The telephone replay will be available shortly after completion of this call. The archived webcast will be available for one year on our website at SPPIRX.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held on November 10th, 2022. Since then, Spectrum may have made announcements related to the topics discussed, so please refer to the company's most recent press releases and SEC filings. And with that, I'll turn the call over to Spectrum's president and CEO, Tom Riga.

Thanks, Mike. Good afternoon, everybody, and thank you for joining us on today's call. The third quarter was very busy for the company. highlighted by two significant regulatory events, along with the signing of a strategic debt financing agreement that improved the balance sheet. Each of these topics will be covered on today's call. I am thrilled that the FDA approved Rolvidon on September 9th, and in less than six weeks, we were able to make the product commercially available to our customers. As of October 18th, Rolvidon is commercially available. And I am pleased that the first commercial sale happened within days of availability. This marks a significant accomplishment for Spectrum and our partner at Homni Pharmaceuticals. We now turn our focus to being a commercial organization. The market opportunity we are entering is the largest in Spectrum's history and one where our leadership team has extensive experience. The estimated $2 billion long-acting growth factor market is both competitive and complex, but we feel Spectrum is uniquely qualified to capitalize on this significant opportunity. There are several factors working in our favor that will allow us to maximize the launch trajectory of Rolvidon. First, it has proven to be safe and effective in two large Phase III studies. Additionally, we are launching with a full suite of resources to support patients and provide customers with the best possible experience. And finally, we hired a strong team with extensive oncology market knowledge, customer connectivity, and learnings from in-depth market research. Let me share with you some of the details. Rovodan is a novel product with a unique molecular structure and has proven to be safe and effective in over 600 patients in the clinical program. The incidence and duration of severe neutropenia is a leading indicator that can predict downstream febrile neutropenia and associated complications. In two large phase three head-to-head studies, Rovodan demonstrated an effect on both the incidence and duration of severe neutropenia and demonstrated non-inferiority versus the market leader in LASTA. Having a safe and effective product is the foundation of commercial success. Volvodon is not a biosimilar and is the first full BLA to enter the long-acting growth factor space in over 20 years. An estimated 1.1 million units of long-acting GCSF are administered in the United States every year. And the market is fairly evenly split into three segments, community oncology, 340B hospitals, and non-340B hospitals. Right now, Mulasta represents 60% of the market, while biosimilars represent 40. There are currently four biosimilars available on the market, with two driving a disproportionate concentration of their share. The product mix is evolving as the on-body device has lost significant share over the past few quarters. Providers are open to change, and we believe that our strategy will enable us to compete across segments. We've done a tremendous amount of qualitative and quantitative research with oncologists, buyers, and payers to understand what drives behavior. In the early goings, the community oncology segment will likely be the fastest path to a robust launch trajectory. Over the past several years, community oncology practices have been facing headwinds, which have led to practice consolidation and acquisition by hospitals. This consolidation has resulted in more centralized decision-making. This segment is receptive to tailored contracting and able to make nimble decisions across their networks. Historically, the long-acting growth factor market was stable and dependable as it relates to average selling price and reimbursement dynamics. With multiple products competing in the space has created an unpredictable business climate for the segment to manage their operations. This unpredictability is driven by the fact that the innovator product and the biosimilars are dependent on one another's discounting decisions. which are made across multiple stakeholders. Now more than ever, customers are looking for solutions that provide them predictability in managing their growth factor business in the near and long term. Rolvidon, being a novel product that is not a biosimilar, offers independent reimbursement not tied to the innovator product or the biosimilar. Ultimately, this means that we will have more flexibility on pricing, contracting, and discounting decisions that will offer customers greater visibility into their near-term and long-term business decisions. Finally, the community oncology segment has high utilization of patient access and support programs, and we are bringing a comprehensive offering to the market. We have taken the time to understand the patient journey and the financial burden on cancer patients, and have built a best-in-class customer support system that will include copay assistance, reimbursement support, and dedicated employees to help ensure our customers and ultimately their patients have the optimal experience with Rolvidon. We will first establish Rolvidon with community oncology practices, followed by 340B and non-340B hospitals. We have a comprehensive strategy which will enable us to compete successfully in the evolving oncology ecosystem. Key to this strategy was to build a strong and efficient commercial team with extensive oncology experience and significant customer relationships. The commercial team includes personnel in sales, marketing, access and reimbursement, commercial operations, and medical affairs. We have already hired nearly all 40 targeted positions. The team is fully trained, actively selling, and executing our launch strategy. Having a team is a competitive advantage in an environment where access is increasingly more restricted, and face-to-face time in front of customers is at a premium. We are confident that the people that we hire and the plan that we have developed gives us the best opportunity to capitalize on the launch of Rolvidon. Turning now to Odiotin of NDA, which is under active review at the FDA with the PDUFA date of November 24th. We had an ODAC meeting in September and received a negative vote of nine to four. This obviously was not the outcome we had expected, and we continue to believe that this product could present a meaningful treatment option for patients with this rare form of lung cancer for whom other treatments have failed. While we cannot predict what the FDA will ultimately decide. We are planning for various outcomes, in particular, one in which we do not receive approval. In the event of an unfavorable determination, we intend to be pragmatic in our approach, which will include further managing costs and implementing organizational adjustments. We will continue to act in the best interest of the company, our shareholders, and most importantly, the patients who depend on our medicines. We will provide timely updates on the Poseyotinib program once we receive word from the FDA. In the meantime, we are heavily focused on the successful launch of Rolodon. And as you will hear from Nora, we have just over $100 million in cash and are very well capitalized to execute on our strategy. With that, let me turn the call over to Nora to review our financials.