Spectrum Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to the Spectrum Pharmaceuticals 2Q 2022 Earnings Conference 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 will 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, Senior Vice President of Corporate Strategy and Operations. Please go ahead.

Thank you, operator. Good morning to everyone. Thank you for joining us today for Section Pharmaceutical's second quarter 2022 financial results conference call. Our second quarter financial results press release was sent out earlier this morning and is available on our website at www.sppirx.com. Joining me in the call today from Spectrum Pharmaceuticals will be Tom Riga, President and CEO, Dr. Francois Lebel, Chief Medical Officer, and Nora Brennan, Chief Financial Officer. 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 they will make this morning. 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. With that, let me hand the call over to Tom Riga, CEO of Spectrum.

Good morning, and thank you for joining us on the call today. This is a pivotal time for Spectrum as we work toward FDA approvals in the coming months for our late-stage assets, posiotinib and eflipagrastim, both of which are under active review at the agency. Since the beginning of the year, we have continued to focus on the following three key business objectives. One, gaining FDA approvals and further advancing our two late-stage assets. Two, reducing our operating cash burn. And three, ensuring we are prepared to successfully launch both products. Let me provide highlights, starting with epilipidrastim. Our BLA is under active review with the FDA with a PDUFA date of September 9th, less than a month from today. The pre-approval inspection of HOMNE's drug substance manufacturing facility in South Korea has been conducted by the FDA. As I've stated previously, this inspection was a critical step for an approval. The pre-approval inspection was completed in early July with a comprehensive examination of GMP practices, quality management system, manufacturing processes, and overall state of process control. The inspection resulted with two observations, which were resolved. We have subsequently had labeling discussions with the FDA and await the final regulatory actions. We appreciate the diligent effort that the FDA is making in their review process, and we look forward to their final decision. Let me shift to POSIOTMIP. Our NDA is under active review, and the agency has set a PDUFA date of November 24, 2022, with an initial indication for the treatment of patients with previously treated, locally advanced, or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations. This product has a fast-track designation and is on an accelerated approval pathway. In the second quarter, we advanced the global confirmatory study in support of our application. This is an important and required step in the approval process. We are actively preparing for the upcoming ODAC meeting that will include a discussion of the Poseidon data package that supports the NDA. We anticipate that the ODAC discussion will be centered around the overall risk benefit, dosing, the clinical relevance of the data in the NDA package, and the context in the current treatment landscape. We look forward to the opportunity to highlight the role that posiotinib can play in addressing an important unmet medical need. The ODAC meeting is scheduled for September 22nd and we will share additional information regarding the Poseidon discussion when it becomes available. In anticipation of two FDA approvals later this year, we have kicked off our commercial readiness efforts and our enthusiasm to enter these markets is high. Our commercial leadership infrastructure is in place and we are ready to engage key customers, group purchasing organizations, specialty pharmacies, and third-party payers to ensure we optimize the launch trajectory. We are ready to launch both epilipagrastim and posiotinib upon their respective approvals with a fully integrated commercial infrastructure. This includes sales, access and reimbursement, marketing, commercial operations, and medical affairs. We will launch both products with one sales force and believe we have the resources needed to successfully achieve our goals. we have been strategic in our approach with FTEs and have built a scalable infrastructure that is now in the process of expanding to support our commercialization efforts. Moving to our operations, we have made a concerted effort to minimize our operating cash burn while optimizing our investments in our late-days assets. As you will see in the second quarter financials, we are holding ourselves accountable to reducing the cash burn of the organization. While there will be an increase in SG&A expenses post-product approvals, you can expect to continue to see financial discipline as we become a lean, effective, and successful company. In May, we announced the appointment of Ms. Nora Brennan as the new CFO of Spectrum. This is Nora's first time on our call, and she will be reviewing the financial highlights after Dr. LaBelle's prepared remarks. In a short period of time, Nora's impact to the organization is already being felt. Her deep knowledge of the company as the previous audit chair to the board of directors and her familiarity with the team has allowed her to hit the ground running in her new role. With that, I will now turn the call over to Dr. LaBelle for a more detailed update on our clinical development progress.