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Birgitte Runa, Interim CEO and CSO, explained that both the B3 and B2 collaborations with MSD are progressing according to plan and are on track for a conclusion in 2025. Regarding business development, she noted that discussions are active across the entire R&D pipeline, including both therapeutic areas and target discovery collaborations, with some dialogues being more mature than others.

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Chief Scientific Officer Birgitte Rønø explained that EVX-one primarily induces a CD4 T-cell response due to its peptide-based formulation and clarified the ERV candidate is an 'off-the-shelf' concept not initially combined with personalized vaccines. CEO Christian Kanstrup added that competitor news on gonorrhea underscores the significant unmet medical need and commercial potential for their EBXB2 candidate, though CSO Rønø noted they had not discussed it with partner MSD.

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CEO Christian Kanstrup noted a recent increase in interest for the infectious disease pipeline, partly validated by the MSD deal, but acknowledged ongoing discussions around the EVX-01 oncology data as well. Chief Science Officer Birgitte Rono added that the ERV proof-of-concept data is planned for presentation at a conference in December.

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CEO Christian Kanstrup characterized the partnership discussions as broad-based, covering both the AI platform and pipeline assets, with some being "fairly advanced." He also guided for slightly lower R&D and G&A spending in the second half of the year compared to the first half, resulting in lower overall cash burn.

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Chief Commercial Officer Sherry Korczynski responded that patient demand is driven by a desire for choice, convenience, and ease of use. She noted that competitor advertising is growing the overall rescue market by increasing awareness, which ultimately benefits all non-injectable options by highlighting the need for patients, especially children, to carry their medication.

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Executive Sherry Korczynski stated that reps would be deployed 'almost immediately' following a potential February approval to capitalize on the allergy season ramp-up. CEO Daniel Barber clarified that the initial launch will feature one dosage strength for patients 30 kilos and up, with a junior dose to be developed and launched subsequently.

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CFO Ernie Toth clarified that the cash runway into 2026 supports the Libervant launch and all pre-commercial activities for Anaphylm, but does not include a full sales force ramp-up, which would only occur post-approval. CEO Daniel Barber added that while there is some back-and-forth with the FDA on Libervant's exclusivity, the company's primary focus is on executing its pipeline milestones and letting the exclusivity period expire naturally.

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CEO Mark Baum stated that the company's pipeline, which includes non-pharmaceutical initiatives, will be detailed at the upcoming Investor Day, framing Harrow as a broader 'ophthalmic disease management solution business.' He also confirmed that VEVYE's refill rates are on track, attributing the sustained high rate to the product's excellent tolerability profile, which leads to strong patient adherence.

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CFO Andrew Boll and CEO Mark L. Baum clarified that Harrow did not implement significant price increases and, in some cases, lowered prices. Baum explained that Project Eagle's initial goal is to transition Klarity-C patients to VEVYE, a financially and clinically superior move. He firmly stated that Harrow has no plans to exit the compounding business, describing it as the company's foundational and profitable core.

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CFO Andrew Boll explained that extended payment terms for buy-and-bill products like IHEEZO and TRIESENCE are intentional, allowing customers to complete their own reimbursement cycle before paying Harrow. CEO Mark L. Baum noted that VEVYE's success is driven by the product, team, and market access, which the new program addresses broadly. Regarding the next-gen TRIESENCE, Baum declined to share specifics for competitive reasons but confirmed it is a key part of the long-term brand strategy with an NDA targeted before the end of 2027.

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CEO Christopher Hall stated that significant R&D investment has dramatically reduced test turnaround times, making them competitive in the market, and noted that strong volume growth is evidence of successful operational execution. He mentioned it was still early to define a definitive testing cadence but that IO therapy monitoring appears more frequent than recurrence monitoring, as expected. Regarding the sales strategy, Hall explained that most volume will flow through Tempus's established infrastructure, while the Personalis sales team will support key academic relationships and cover market gaps with non-Tempus customers.

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Executive Christopher Hall explained that the commercial organization is already focused on breast and lung cancer specialists. He confirmed that upon reimbursement, they plan to accelerate by adding more sales representatives and leveraging their partnership with Tempus. Hall noted that physician retention has been very high, with several hundred doctors ordering, and that reorder rates for subsequent patient samples are strong. He also highlighted that over half of direct orders include the comprehensive genomic profiling (CGP) test, indicating a successful integrated strategy.

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Aaron Tachibana, CFO, clarified that the enterprise guidance includes both VA and other enterprise customers, with the VA contract accounting for $7.5 million to $8 million. Christopher Hall, CEO, added that Personalis is approaching 300 physician customers for NeXT Personal and that retention remains very high, driven by the test's ultra-sensitive detection capabilities.

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CEO Christopher Hall clarified that Personalis is aggressively pursuing reimbursement for all three core indications—breast, IO, and lung—in 2025, viewing it as having 'three shots on goal' to secure at least two. Regarding the 2025 outlook, Hall stated that the company remains committed to its internal goal of reaching $100 million in revenue, a target established with the foreknowledge that the Moderna melanoma trial enrollment would be largely completed this year.

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CEO Derek Maetzold confirmed that the company is actively pursuing an FDA submission for DecisionDx Melanoma but did not specify a timeline. CFO Frank Stokes added that while Castle receives some episodic payments for DecisionDx SCC from commercial payers, the amounts are not significant and often appear as prior-period revenue adjustments.

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CEO Derek Maetzold stated that a decision on the SCC test offering depends on interactions with Medicare during the reconsideration process, emphasizing the ethical obligation to offer the test. He also confirmed the atopic dermatitis test is still on track for commercial availability by year-end.

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CFO Frank Stokes confirmed the guidance assumes DecisionDx-SCC reimbursement will continue for nearly the entire fourth quarter. He also expressed satisfaction with the progress of the new TissueCypher sales reps hired in April, stating they are tracking as expected and should reach full productivity heading into the next year.

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CEO Roderick de Greef detailed two CapEx projects: a near-term, sub-$10 million expansion of biopreservation media capacity and a larger project in 2026 to build a new facility in Indianapolis for hPL manufacturing and product fulfillment. CFO Troy Wichterman added that the business has minimal seasonality, with only a potential for slight slowness in Europe during summer months.

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CEO Roderick de Greef suggested that while growth could accelerate over time, it would be 24-36 months before non-media products could materially impact the growth rate, which remains dependent on therapy approvals. Executive Troy Wichterman confirmed no further significant P&L changes are anticipated, reaffirming his earlier comments on SG&A and R&D spending baselines.

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CEO Roderick de Greef stated that smaller customers are 'coming along fine,' with distributor performance serving as a positive proxy for this segment. Regarding geography, he noted that Asia is not a material driver, with China specifically accounting for less than 5% of revenue. He added that the company does not foresee any impact from geopolitical issues like the BioSecure Act.

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