Ram Selvaraju

Ram Selvaraju asked if Soleno is evaluating other disease indications for VYKAT XR beyond GSD I, such as Smith-Magenis syndrome. He also inquired about potential pricing flexibility impacts if the drug is launched in Europe, and the underlying dynamics of the discontinuation rate, specifically if it's plateauing or declining.

Answer

Anish Bhatnagar, Chairman and CEO, confirmed that the company is evaluating other rare diseases with hyperphagia or food-related behaviors, including Smith-Magenis syndrome and Fragile X. He noted that controlling pricing in both the U.S. and Europe would optimize flexibility, acknowledging that orphan exclusion in MFN is not yet a reality. He added that early indicators suggest the cadence of discontinuations is similar to clinical trials, where patients who stay on drug past titration are likely to remain on therapy.

Ram Selvaraju inquired about the evaluation of VYKAT XR for other disease indications beyond GSD I, such as Smith-Magenis syndrome, the potential pricing flexibility impact if Soleno were to launch the drug in Europe, and the underlying dynamics of the discontinuation rate (plateauing, declining, or increasing).

Answer

Anish Bhatnagar, Chairman and CEO, confirmed ongoing evaluation of DCCR for other rare diseases with hyperphagia or food-related behaviors, including Smith-Magenis syndrome and Fragile X. He stated that controlling commercialization in Europe would likely optimize pricing flexibility. Regarding discontinuation rates, he noted early indicators suggest that patients who remain on drug past titration are likely to stay on long-term, mirroring clinical trial observations.

Ram Selvaraju asked about the expected ultimate reimbursement and market access for Auvelity at steady state, particularly comparing it to Sunosi's 82% covered lives, and whether it would go meaningfully higher, seeking the optimal range.

Answer

Ari Maizel (Chief Commercial Officer, Axsome Therapeutics) stated that Axsome's goal is to secure access for as many patients as possible across channels, and while not guiding on final steady-state covered lives, he expects continued progress in increasing covered lives for both MDD and ADA indications.

Ram Selvaraju asked about Axsome's expectations for Auvelity's ultimate reimbursement and market access at steady state, comparing it to Sunosi's 82% covered lives, and whether it would be similar or meaningfully higher across both MDD and chronic agitation indications.

Answer

Ari Maizel, Chief Commercial Officer, stated that Axsome's goal is to secure access for as many patients as possible across all channels. While not providing specific guidance on the final steady-state covered lives percentage, he expressed expectations for continued progress in increasing access for both the MDD and ADA indications.

Ram Selvaraju inquired about Balchem's planned sales and promotional activities for 2026, including the evolution of professional sports team partnerships, the potential impact of the Supreme Court decision on the tariff regime, and assumptions for the effective tax rate. He also asked about FX headwinds/tailwinds and capital deployment priorities.

Answer

Chairman, President, and CEO Ted Harris stated that multi-year partnerships with the Jets and Bayern Munich will continue, supplemented by increased social media and influencer marketing. He announced a new marketing focus on MSM for 'beauty from within' campaigns. Regarding tariffs, he noted Balchem's strong position due to regional manufacturing and market strength, managing previous disruptions effectively, and anticipates volatility but no significant opportunities from potential rollbacks. CFO Martin Bengtsson advised using a 23% effective tax rate for modeling, citing recent historical rates. He also explained that USD/Euro is the primary FX exposure, which had a favorable but manageable impact in 2025, and confirmed capital deployment priorities remain organic growth, M&A, dividend growth, and debt repayment, with recent share repurchases aimed at maintaining a flat share count given low leverage.

Ram Selvaraju asked about Balchem's planned sales and promotional activities for 2026, including the evolution of professional sports team partnerships and H&H product promotion. He also questioned the potential impact of the Supreme Court's tariff regime decision, mitigation measures, and opportunities from tariff rollbacks. Additionally, he sought guidance on effective tax rate assumptions, potential FX headwinds/tailwinds, and capital deployment priorities.

Answer

Chairman, President, and CEO Ted Harris confirmed the multi-year Jets and Bayern Munich partnerships would continue, supplemented by increased social media and influencer marketing. He announced a new 'beauty from within' campaign for MSM. Regarding tariffs, Mr. Harris stated Balchem managed previous disruptions well due to regional manufacturing and strong market positions, expecting any future volatility to be manageable with no significant opportunities foreseen. CFO Martin Bengtsson advised using 23% for effective tax rate modeling, noted the USD/Euro as the primary FX exposure with a favorable 0.7% impact on 2025 growth, and reiterated consistent capital deployment priorities: organic growth, dividend, M&A, and debt repayment, with recent share repurchases aimed at offsetting dilution given low leverage.

Ram Selvaraju inquired about the impact of international anti-dumping practices, specifically the status of European anti-dumping duties on China-origin choline, on Balchem's Human Nutrition and Health segment. He also asked for an update on the Orange County microencapsulation manufacturing facility's completion timeline and its expected impact on revenues and earnings quality. Additionally, Selvaraju questioned the future pace of debt repayment and the appropriate effective tax rate assumption for the remainder of 2025.

Answer

Ted Harris, Chairman, President, and CEO, confirmed that the EU's preliminary anti-dumping duties on China-origin choline chloride (for both human and animal use) are progressing, with a final vote expected by year-end, and would be in place for five years. He also detailed that the new Orange County microencapsulation plant, with twice the capacity, is expected to be completed by early 2027 and producing by mid-2027, supporting continued double-digit growth in this high-margin business. Martin Bengtsson, CFO, stated that the effective tax rate for 2025 is estimated around 22.5%. He added that the pace of debt repayment, while strong, would depend on M&A timing and anti-dilutive share repurchases.

Ram Selvaraju inquired about the specifics of the EMA's re-examination process for blarcamesine, including the identity of the new rapporteurs, the expected timeline for the review, and the company's anticipated formal NDA submission timeline with the FDA, as well as the type of recent FDA meeting.

Answer

President and CEO Christopher Missling explained that the two rapporteurs would be from the 27 EU countries and confirmed the re-examination process is expected to last for the first half of the year, following a 60+60-day response and review period. He noted that the FDA NDA submission plan would advance closer to the time, following a productive Type C meeting where Anavex committed to providing the full data package.

Ram Selvaraju asked for additional information regarding the rapporteur and co-rapporteur for the EMA re-examination of blarcamesine, the anticipated timeline for this re-examination, and the timeline for a formal NDA submission with the FDA, including the type of recent FDA meeting.

Answer

President and CEO Christopher Missling explained that the rapporteurs are from two of the 27 EU countries, and the re-examination process is expected to last for the first half of the year, involving a 60+60 day period for response and review. He noted that the FDA submission plan will advance closer to the time, following a productive Type C meeting where Anavex was requested to provide the full data package.

Ram Selvaraju asked about the commercial outlook for chronic refractory cough, particularly in light of Gefapixent's market performance, the next funding catalysts and potential public listing for Stalicla, competitive clinical development in post-stroke recovery including CCR5 receptor modulators and learnings from the Camaris trial, and expected catalysts from the ongoing collaboration with Indivior in 2026.

Answer

CEO Tim Dyer noted that Gefapixent is not performing well and is not registered in the U.S., while Camlipixent (acquired by GSK) shows promise with upcoming Phase 3 data. He highlighted the significant unmet need in cough, the limitations of Baclofen, and the high discontinuation/non-response rates for P2X3 inhibitors. Head of Translational Science Mikhail Kalinichev added that P2X3 inhibitors only address peripheral mechanisms, while centrally acting GABA-B PAMs could address broader patient needs. For Stalicla, Tim Dyer explained they are executing a washout study, recruiting for a non-pharmacological intervention, and working on Series C financing for two Phase 2 autism programs, as well as out-licensing Mavoglurant for cocaine use disorder, with a potential IPO being considered. Regarding stroke, Tim Dyer mentioned plans to collaborate with the lead investigator of the Camaris trial, Sean Duclos, to learn from their study. Mikhail Kalinichev elaborated on the parallels between CCR5 and mGluR5 in post-stroke recovery, both being upregulated GPCRs whose inhibition facilitates recovery, and emphasized learning from Camaris regarding sensory versus motor recovery readouts. For Indivior, Tim Dyer stated they successfully completed IND-enabling studies and are preparing to advance the program, but could not provide further details at this stage.

Ram Selvaraju (H.C. Wainwright) asked about the anticipated attrition rate among patients for whom ZEVASKYN Product Order Forms (ZPOFs) have been received, and for a description of the prior authorization process, particularly for RDEB patients with large chronic open wounds, including any step edits.

Answer

Madhav Vasanthavada (Chief Commercial Officer, Abeona) stated that a very high level of conversion is expected for ZPOF patients, as they are highly motivated and physicians have prioritized them. Vishwas Seshadri (CEO, Abeona) reinforced this, noting that the 12 ZPOFs represent the highest priority patients from a larger pool, implying low attrition. Madhav Vasanthavada (Chief Commercial Officer, Abeona) detailed the prior authorization process, involving clinical prior authorization (following clinical trial inclusion/exclusion criteria or label) and financial discussions. He noted that most payers cover to label, with no specific wound size requirements, and that initial denials for age-related policies can be overturned with a letter of medical necessity. He confirmed no meaningful step edits have been observed.

Ram Selvaraju asked about the expected attrition rate among patients for whom ZEVASKYN Product Order Forms (ZPOFs) have been received, before they complete the entire treatment process. He also sought a description of the prior authorization (PA) process, particularly for RDEB patients with large chronic open wounds, and whether any meaningful step edits are being mandated by payers.

Answer

CEO Vishwas Seshadri indicated a "pretty high level of conversion" for ZPOF patients, citing their motivation and the high success rate from clinical trials. He highlighted that 12 ZPOFs from a "little over a dozen" identified patients demonstrates strong initial interest and low attrition. Chief Commercial Officer Madhav Vasanthavada explained the PA process involves clinical authorization (following trial inclusion/exclusion criteria or label) and financial discussions. He noted that most payers cover to label, with some age restrictions that can be overturned with a letter of medical necessity. Vishwas Seshadri confirmed that no step edits have been observed.

Ram Selvaraju asked about the expected resolution timeline for the situation with Rockwell Medical's former largest customer, the timing for providing 2026 revenue guidance, potential business development activities given the strong balance sheet, and the near-to-medium term prospects for the bicarbonate disposables business.

Answer

Dr. Marc Strobeck, President, CEO, and MD of Rockwell Medical, stated that the situation with the former largest customer is expected to resolve this quarter, with contract discussions ongoing. He anticipates providing 2026 guidance with the fourth-quarter earnings release. Dr. Strobeck also mentioned active discussions with multiple companies regarding acquisitions to leverage the strong cash balance as growth capital. Regarding the bicarbonate disposables business, he highlighted the significant opportunity for growth and higher margins with the recently launched bicarbonate cartridge, expecting increased adoption from existing customers.

Ram Selvaraju inquired about the expected resolution timeline for the situation with Rockwell Medical's former largest customer, the anticipated release of 2026 revenue guidance, and the company's plans for business development activities. He also asked about the near and medium-term prospects for the bicarbonate disposables business.

Answer

Dr. Mark Strobeck, President and CEO, stated that the company expects to resolve the situation with the former largest customer this quarter, with contract discussions ongoing. He indicated that 2026 guidance would likely be provided early next year, coinciding with the Q4 earnings release. Dr. Strobeck also highlighted active business development, including discussions for multiple company acquisitions utilizing the strong cash balance as growth capital. Regarding bicarbonate disposables, he emphasized the significant growth opportunity and higher margins for the bicarbonate cartridge, noting that the company is now positioned to maximize its potential after initial implementation efforts.

Asked for details on expansion plans in the Western U.S., the status of negotiations with their former largest customer, capital allocation priorities, and how new long-term contracts will affect revenue predictability in 2026.

Answer

The Western U.S. is viewed as a significant, $100M opportunity, with more clarity expected later in the year. Discussions with the former largest customer, DaVita, are ongoing for a new long-term agreement, and the company is optimistic about a positive outcome. Capital is being prioritized for manufacturing automation and new customer acquisition. The shift to long-term contracts is intended to create a reliable and reproducible revenue stream, stabilizing the business for future growth after the recent transition.

Ram Selvaraju of H.C. Wainwright inquired about BrainsWay's future metrics reporting granularity, specifically concerning total install base growth and individual minority investment performance. He also asked for an update on the Deep TMS system upgrade cycle and the expected geographic drivers for international business growth in 2026. Additionally, Mr. Selvaraju asked CFO Ido Marom about potential changes to revenue reporting given the new minority stakes.

Answer

CEO Hadar Levy stated that future metrics will include systems shipped quarterly, additional indications sold, book-to-bill ratio, and progress on minority investments, with more details to be shared at the December 1st analyst day. Mr. Levy highlighted strong international growth expected from Asia-Pacific (Japan, China, South Korea, Taiwan, Thailand, India) and key European countries, along with the Israeli market, driven by increased awareness and new indications beyond mental health. CFO Ido Marom clarified that minority investments are not expected to impact top-line revenue and will be recorded at fair value or as equity under operating profit, pending auditor review.

Ram Selvaraju inquired about BrainsWay's future metrics reporting granularity, the state of the international business and expected growth regions for 2026, and how revenue reporting might change given minority stakes.

Answer

CEO Hadar Levy outlined future KPIs including quarterly system shipments, additional indications sold, book-to-bill ratio, and more details on minority investments, with further information at the December 1st analyst day. He also highlighted strengthening international distribution in Asia-Pacific and Europe, with potential for faster expansion in addiction and neurology indications. CFO Ido Marom clarified that minority investments would not impact top-line revenue, being recorded at fair value or as equity under operating profit.

Asked about the competitive landscape for DLB, the potential for approval based on neuropsychiatric parameters, the outlook for accelerated approval for Alzheimer's drugs in the US versus Europe, and the prospects for near-term grant funding from the NIH.

Answer

The company is confident in discussing neuropsychiatric symptoms as a key endpoint for DLB with the FDA, as these are core to the disease. They are pursuing a traditional, not accelerated, approval pathway for Alzheimer's in both the US and Europe. Regarding funding, they have a $50 million balance from an existing NIH grant but do not anticipate new grants for Phase III programs, expecting to rely on capital markets or partnerships instead.

Asked about potential 2025 tailwinds from NIAGEN IV uptake and capturing market share from NMN, the potential market opportunity from a positive Parkinson's study, and future strategies for developing an Rx product, including a potential spinout.

Answer

The company is confident the FDA will maintain its stance on NMN and is more focused on combating other fraudulent players in the NAD market. A positive Parkinson's study could have a very significant impact on sales. For an Rx strategy, the company has other patented NAD precursors that could be developed as drugs. A spinout of the pharmaceutical assets is a possibility if capital is needed or a partner is only interested in the Rx business, but it is not the current plan.

Asked about plans for commercial infrastructure and partnerships for D-PLEX100, key international markets, and the timeline for an FDA submission post-trial completion.

Answer

The company plans to commercialize in the U.S. with a strategic partner and is in discussions that will accelerate after top-line results. The product has a global market, with key regions outside the U.S. and Europe being South America, China, India, and Japan. An NDA submission is anticipated during 2026, assuming top-line results in Q1 and leveraging the breakthrough therapy designation.

Asked about the tebipenem Phase III trial's site count and enrollment factors, the conversion mechanism of SPR720 to its active moiety, and potential future combination studies for SPR720.

Answer

The executive stated the tebipenem trial has a triple-digit number of global sites and is on track for enrollment completion in H2 2025. They described the SPR720 conversion as rapid and mentioned that while current combination studies with azithromycin and ethambutol are sufficient for now, future ones will be considered as the treatment landscape evolves.

Asked about the usability of data from a previously paused study, its potential to offset future costs, and any updates on the OnkosXcel asset.

Answer

All safety data from the paused study is usable for the NDA submission package, though it cannot be rolled into a new study and is a minor cost consideration. The company has formally begun exploring strategic options like partnering or monetization for its OnkosXcel asset.

Ram Selvaraju of H.C. Wainwright asked about emerging trends in private pay or non-reimbursed demand for Phexxi, the company's updated strategy for the cancer patient population, and how Evofem plans to optimize the value of the STI indication, including potential business development.

Answer

CEO Saundra Pelletier confirmed the company is actively seeking U.S. co-promotion partners and ex-U.S. partnerships to maximize the STI opportunity and bring in non-dilutive capital. She also noted growing interest from oncologists in Phexxi for their patients. Chief Commercial Officer Katherine Atkinson mentioned a new cash card program to support access. CFO Jay File stated that while self-pay has not been a significant portion of sales, they will have better visibility on recent trends in Q3.

Ram Selvaraju from H.C. Wainwright asked for details on commercial efficiency initiatives, the projected commercial exclusivity window for the STI prevention indication, and the additional resources required to support a potential launch for that new indication.

Answer

CEO Saundra Pelletier detailed several efficiency initiatives, including leveraging increased payer access, grassroots marketing on college campuses, bringing creative marketing in-house, and using internal analytics for real-time adjustments. She confirmed the STI indication would add five years of exclusivity, extending it to 2038. For the launch, she anticipates a sales force expansion of 15-25 reps and investment in an educational platform. CFO Jay File added that the launch would be less costly than the initial one due to existing market penetration.

Ram Selvaraju of H.C. Wainwright asked for the 2022 revenue guidance, future commercial performance metrics, the percentage of covered lives affected by reluctant insurers, details on the Orion collaboration beyond HIV, and the timeline for ex-U.S. Phexxi partnerships.

Answer

CFO Jay File reiterated the 2022 net revenue guidance of $30-$35 million. CEO Saundra Pelletier estimated that reluctant insurers represent a 30% coverage gap but noted prior authorizations are effective. She clarified the Orion collaboration is focused on HIV and a new thin-film delivery system. Regarding ex-U.S. deals, she explained the process was slowed to await STI indication data, which will significantly increase Phexxi's valuation and attract more substantial partners.

Ram Selvaraju of H.C. Wainwright & Co., LLC inquired about the market potential for Phexxi in Mexico, the strategy for targeting women undergoing cancer treatment, the rationale for shifting marketing from capital-intensive TV to digital channels, and the outlook for pricing stability.

Answer

CEO Saundra Pelletier highlighted that Phexxi's hormone-free profile resonates well with the Latin American market and that the product is gaining traction in the oncology community, a point used to advocate for better coverage in D.C. She confirmed the marketing shift to digital was a strategic move after building sufficient brand awareness. CFO Jay File stated that after a recent price increase, pricing is expected to remain stable until the next annual review.

Ram Selvaraju from H.C. Wainwright asked about the timing for the final top-line data from the GTB-3550 trial and potential conference presentation. He also inquired about the likely positioning of GTB-3550 in the AML treatment continuum, details on the B7H3 targeted TriKE's preclinical data and competitive landscape, and ideal combination regimens for other early-stage candidates.

Answer

CMO Dr. Greg Berk explained that establishing the MTD will determine the final data timing, likely for a conference in late winter or early spring. CEO Tony Cataldo discussed the treatment strategy, starting with monotherapy for relapsed/refractory AML and potentially moving to combinations with standard care like venetoclax. CTO Martin Schroeder noted the B7H3 TriKE shows good preclinical killing in several cancers. Both he and the CEO highlighted the focus on developing versatile dual-targeting TriKEs over standard combination therapies.