Delcath(US:DCTH)2022-11-08 18:33Financial Data and Key Metrics Changes - Product revenues for Q3 2022 were approximately $906,000, a 129% increase compared to $395,000 in the prior quarter, primarily due to the termination of the medac distribution agreement [23][24] - The net loss for Q3 2022 was $8.5 million, or $0.92 per share, compared to a net loss of $7.1 million, or $0.94 per share for the same period in 2021 [26] - Cash, cash equivalents, and restricted cash totaled $14 million as of September 30, 2022, down from $27 million on December 31, 2021 [27] Business Line Data and Key Metrics Changes - In Europe, CHEMOSAT units increased by 41% year-over-year and 26% sequentially from Q2 to Q3 2022 [15] - The company is on track to file the HEPZATO KIT NDA with the FDA by the end of December 2022 [8] Market Data and Key Metrics Changes - The company has two centers treating patients under the Expanded Access Program (EAP) in the U.S., with a third center pending training [7] - The CHOPIN trial is progressing with approximately 50% of the planned 76 patients enrolled [11] Company Strategy and Development Direction - The company aims to operate on a cash flow breakeven basis while making key hires in Germany to support national coverage submissions [16] - The focus is on the commercialization of HEPZATO, with plans for market access and reimbursement strategies for Medicare patients [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming NDA submission and the potential for rapid revenue growth post-approval [22] - The company is monitoring referral patterns and believes that HEPZATO and KIMMTRAK can be used in a complementary manner for patient treatment [36] Other Important Information - A settlement agreement with medac regarding the termination of the distribution agreement is expected by the end of 2022 [17] - The company successfully completed a Notified Body audit for its manufacturing facility under the European Medical Device Regulation [18] Q&A Session Summary Question: Updates on CROs and NDA resubmission - Management indicated that medical writing is the primary gating item for the NDA resubmission, expected by the end of December [31] Question: EAP site treatments and learnings - A total of seven treatments have been conducted, with an eighth scheduled, and early learnings are being applied to inform referral pathways [33] Question: FDA review timeline and panel meetings - Management is focused on ensuring a complete submission package to facilitate a smooth review process, with no meetings scheduled with the FDA at this time [40] Question: European revenue trends - Management noted that revenue growth may be lumpy due to small numbers, but hiring a representative in Germany is expected to improve referral patterns [41] Question: Volume expectations post-approval - An average of one treatment per week per site is anticipated post-launch, with potential for growth to 20 sites over two years [43] Question: FOCUS study final survival data - The primary endpoint is objective response rate, and there is no need to update the data for FDA submission, but the agency will be kept informed [45] Question: Operating expenses outlook - Management expects operating expenses to remain steady for the next two quarters [46] Question: FDA facility inspection timeline - A preapproval inspection is expected to be scheduled four to six weeks prior to the PDUFA date [47] Question: FDA expectations for pivotal data - Management highlighted the importance of demonstrating clinically meaningful objective response and duration of response, with favorable comparisons to existing treatments [50]