Eiger BioPharmaceuticals, Inc.

are late-stage and, we believe, highly differentiated from other therapies in clinical development. Lonefarnib ritonavir is the only oral therapy in clinical development for HDV, and we expect that patient preference for a convenient all-oral HDV therapy or a combination with interferon that delivers a robust response will be high. By the time we launch Lonefarnib, We expect increased awareness and diagnosis rates of hepatitis delta virus made possible by greater utilization of commercial HDB PCR tests and updates to EASL and AASLD testing guidelines. In the future, we believe that as a first in class type three interferon, PEG interferon lambda's tolerability profile has the potential to make it the interferon of choice for physicians and patients, leading to better compliance and improved outcomes. We are planning for a focused and cost-efficient HDB commercial launch. The same physicians who treat patients with HBV treat patients with Delta virus, and Delta is only found as a co-infection with HBV. As you can see from this map, in the U.S., HBV prescribers are heavily concentrated in major metropolitan areas. Seventy percent of HBV scripts are written by 10 percent of HBV prescribers, a dynamic that allows for a lean, targeted field force. Outside the U.S., we believe that delivered data could provide opportunities for strategic collaborations. While we're planning for a successful U.S. launch, we are preserving our options for partnerships in both the U.S. and in Europe. In China, where there are estimated to be more than one million hepatitis delta patients we will pursue a partnering strategy to provide access to patients in this important market while maximizing potential for shareholder value. Following delivered results, we plan to share additional details on our plans for commercialization of Lona Farna-based regimens for HDV. Finally, a quick update on Zikinbi. We reported $4 million in net sales during the third quarter in the U.S. As we previously stated, 80% of identified U.S. patients with progeria receives Akinvi with 100% payer reimbursement coverage. In July, we announced EMA approval of Akinvi. Demonstrating success in our reimbursement strategy, we secured reimbursement in two of the largest European markets. In France, under our Reimburse Early Access Program, and most importantly, in Germany. We expect our first shipment to Germany by the end of this year. We have appropriate infrastructure in place for a successful commercialization across the EU, including distribution and patient support services. We're engaged with healthcare providers who are managing patients with progeria, as well as reimbursement authorities, ministries of health, and local payers to obtain reimbursement in each country. In summary, we're pleased with our progress to date, excited about the commercial potential of our programs, and confident and our ability to execute an efficient launch of Lona Farna-based regimens for HDV. As I've noted before, the infrastructure we've established in the U.S. and now in Europe for the launches of Kinsey for Progeria has been designed to scale and grow to support future launches and larger indications, including HDV, as we advance our mission to help patients with serious diseases. We'll now hand the call over to Sri for a financial update.

Thanks, Elden. The press release we issued this afternoon includes a financial update, and I'll call out a few highlights here. As Elden noted, total revenue this quarter was $4 million, which consisted entirely of U.S. OTV net sales. This compares to $3 million reported for third quarter 2021 and $3.3 million for second quarter 2022. Higher net sales in Q3 were largely driven by additional unit shift during the quarter. Turning to our third quarter 2022 GAAP operating expenses, cost of sales was $1.2 million, which included a one-time write-off of a non-conforming batch of inventory in the quarter. R&D expenses were $22.2 million, and SG&A expenses were $7 million for the quarter. We reported a third quarter net loss of $27.1 million, or 62 cents, on a per share basis. As we've discussed before, a key part of our growth strategy is to develop and commercialize innovative therapies for underserved patients in a capital and resource-efficient manner. To that end, we have been disciplined managing our expenses as we've advanced multiple programs into and through Phase 3. With approximately $121 million in cash, cash equivalents, and investments as of September 30th, we are well-positioned ahead of important milestones and catalysts. We expect this cash to fund planned operations through 2024 before potential commercialization in HDB. Importantly, we have access to additional non-diluted capital under our debt facility that we entered into earlier this year. Iger can access up to $35 million in additional cash contingent on positive clinical and regulatory milestones across two tranches, which could be instrumental to fund our bona farde HDB commercial launch expenses. We'll now open up the call for Q&A. Operator, please provide the instructions for the Q&A portion of the call.

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