Matthew Caufield

Matthew Caufield inquired about Phathom Pharmaceuticals' longer-term thoughts on prospective entrants into the PCAB space, specifically mentioning Sebela's Tocopizan, and strategies for maintaining Voquezna's market positioning.

Answer

Steven Basta, President and CEO, acknowledged tracking competitive PCAB developments, including Tocopizan, which may be approved by early 2027. He emphasized that with Voquezna at 1% penetration in a 110 million PPI prescription market, a second entrant would likely grow overall PCAB awareness and shift physician mindset to the 'category,' which he believes will accrue to Voquezna's benefit as the first entrant with established history and access.

Matthew Caufield from H.C. Wainwright inquired about Phathom's longer-term thoughts on prospective entrants into the PCAB space, specifically mentioning Sebela's Tegoprazan, and strategies for maintaining VOQUEZNA's positioning.

Answer

Steven Basta, President and CEO, acknowledged Tegoprazan's NDA filing and potential approval by early 2027. He expressed belief that a second PCAB entrant would grow overall PCAB awareness and the category broadly, which would ultimately accrue to VOQUEZNA's benefit as the first entrant with established history and broad access, rather than directly competing for existing prescriptions.

Matthew Caufield of H.C. Wainwright & Co. asked about the expected steady-state balance between retail pharmacy and BlinkRx cash-pay prescriptions and inquired about the average cash-pay price for patients.

Answer

Steven Basta, President, CEO & Director, responded that the company's goal is to grow total script volume across all channels rather than managing a specific ratio. He clarified that the BlinkRx cash-pay price is $50 for patients without insurance coverage, while those with coverage are offered a $25 copay.

Matthew Caufield asked whether any potential resistance to new prescriptions stems more from prescriber acceptance of the novel mechanism or from initial insurance coverage hurdles.

Answer

CCO Martin Gilligan stated that the company does not see resistance to VOQUEZNA. He explained that physicians welcome the new mechanism and recognize its benefits, with adoption growing as they gain positive patient experience, particularly regarding its rapid and durable 24-hour effect.

Matthew Caufield asked for observations on the H. pylori indication, including prescriber engagement versus standard of care and its potential role as a gateway for physicians to later prescribe VOQUEZNA for GERD.

Answer

Chief Commercial Officer Martin Gilligan stated that while GERD is the primary focus, the H. pylori indication is an important part of the business. He explained that its potent acid suppression helps reinforce the overall mechanism of action for physicians, which has a payoff for GERD prescribing. He confirmed that some physicians are adopting it as a preferred treatment and that some H. pylori patients do transition to GERD therapy.

Matthew Caufield inquired about the ex-U.S. opportunities for TP-03, specifically in Europe, Japan, and China, and how these markets compare in terms of anticipated prescriber receptivity and overall market dynamics.

Answer

David Nakasone, Head of Investor Relations, explained that ex-U.S. market dynamics for TP-03 are largely similar to the U.S. in terms of disease prevalence and pre-XDEMVY treatment paradigms, with doctors eager for definitive treatments. He noted that the positive U.S. experience is generating significant interest among European doctors, and while pricing and reimbursement differ, patient and physician dynamics are very similar, which will guide the go-to-market approach.

Matthew Caufield asked for more information on the ex-U.S. opportunities for TP-03, specifically in Europe, Japan, and China, and how these markets compare in terms of anticipated prescriber receptivity.

Answer

David Nakasone, Head of Investor Relations, explained that ex-U.S. market dynamics are very similar to the U.S. in terms of disease prevalence and pre-XDEMVY treatment paradigms. He noted that the positive U.S. experience is generating excitement among European doctors, and while pricing and reimbursement will dictate the go-to-market approach, patient and physician dynamics are similar.

Matthew Caufield from H.C. Wainwright & Co. asked about the role of patient overlap with related conditions (e.g., dry eye, cataracts) in driving new prescriptions for Xtendi.

Answer

CCO Aziz Mottiwala explained that while Demodex blepharitis (DB) is always the underlying diagnosis, physicians are increasingly screening for it in patients presenting with other conditions, which motivates new prescribers. CEO Bobak Azamian added that Tarsus plans to roll out more studies to build evidence for use in patients with comorbid conditions, further driving education and adoption.

Matthew Caufield of H.C. Wainwright & Co. asked if there was any reason to believe the FDA might apply extra scrutiny to the serum potassium safety data during the pre-NDA review.

Answer

CEO Jon Congleton responded with confidence, stating that the FDA would likely value the comprehensive safety characterization across diverse patient populations (real-world, optimized, and CKD). He believes the thoroughness of the clinical program, which was designed to assess the drug's profile across this spectrum, will be viewed favorably by the agency.

Matthew Caufield of H.C. Wainwright & Co. asked for more detail on the mechanism and expectations for lorundrostat's benefit in obstructive sleep apnea (OSA) and any potential read-through from the ongoing hypertension trials.

Answer

Chief Medical Officer Dr. David Rodman explained a dual mechanism for OSA. The primary focus is treating the severe, underdiagnosed nocturnal hypertension driven by hypoxia-induced aldosterone surges, which is a direct read-through from their hypertension program. A secondary potential benefit is reducing airway obstruction itself through decreased fluid shifts and inflammation, which could be additive to standard CPAP therapy and improve outcomes.

Matthew Caufield from H.C. Wainwright & Co. asked if the 6-to-8 mmHg ambulatory blood pressure reduction, described as clinically meaningful during a KOL event, is the same target range for success in the Launch-HTN and Explore-CKD trials.

Answer

Executive Jon Congleton confirmed that this range is considered meaningful across all trials, noting that even a 1-2 mmHg reduction lowers cardiovascular risk. He reiterated that replicating the 8-10 mmHg reduction from Target-HTN would be 'truly meaningful' and transformative for the market. He affirmed this standard of success applies to Explore-CKD, which also aims to show benefits for renal function.

Matthew Caufield from H.C. Wainwright & Co. asked about the potential for positive preeclampsia data to derisk or provide a read-through for the company's acute ischemic stroke (AIS) development program.

Answer

Executive Dietrich Pauls explained that while the indications are distinct, positive preeclampsia results would serve as another confirmation of the protein's activity. He highlighted that other forms of the protein are already used in Asia to treat both stroke and preeclampsia, which provides a rationale for pursuing both indications with DM199.

Matthew Caufield questioned what would constitute a meaningful blood pressure reduction in the upcoming preeclampsia data to de-risk the program. He also asked for confirmation that the amended statistical analysis plan for ReMEDy2 has been finalized with the FDA.

Answer

Dr. Lorianne Masuoka, Chief Medical Officer, stated that for the preeclampsia study, a 10-20 mmHg drop in systolic pressure, evidence of improved placental perfusion, and no signs of the drug crossing the placental barrier would be a 'huge signal' for success. She also confirmed that the amended statistical analysis plan for the ReMEDy2 trial has been finalized with the FDA.

Matthew Caufield questioned the logistics of using frozen versus refrigerated vials in the preeclampsia study and asked about the potential risk of the FDA providing subsequent feedback on the ReMEDy2 protocol modifications after implementation had already begun.

Answer

Dr. Lorianne Masuoka, Chief Medical Officer, confirmed that while initial patients may receive the frozen product, the refrigerated version will be used primarily and the two are identical. Regarding the FDA, she stated that since the 30-day window for feedback on the protocol amendment has passed, the chance of receiving substantive comments from the agency is now considered relatively low.

Asked about the difference in uptake between polyp and non-polyp patients and the main source of prescriber hesitation.

Answer

The company cannot reliably distinguish prescriptions by diagnosis (polyp vs. non-polyp) from the available data. The main challenge with prescribers is not 'pushback,' but the educational effort required to convince them of XHANCE's unique clinical benefits, as their prior experience with standard nasal steroids was not positive. This takes time and repeated messaging.