Brandon Folkes

Brandon Folkes from H.C. Wainwright & Co. inquired about the recent market research for Afrezza's pediatric opportunity, specifically asking about initial patient adoption trends, whether from new patient starts or switch patients, and the potential for an upfront bolus of switch patients seeking needle-free or pump-free options. He also asked about the second molecule (1505) in the United Therapeutics collaboration, seeking insights into any molecule-specific factors that instill confidence in its dry powder development.

Answer

CEO Michael Castagna highlighted new market research confirming a substantial pediatric opportunity for Afrezza, noting surprising potential from naive patients and the importance of the INHALE-1 study for launch preparation. He anticipates initial adoption primarily from switch patients, with a methodical launch approach before a broader consumer campaign. Regarding the second UT molecule (1505), Mr. Castagna confirmed ongoing collaboration and progress, but reiterated that United Therapeutics ultimately determines its advancement.

Brandon Folkes inquired about the market research findings for Afrezza's pediatric opportunity, specifically regarding initial patient adoption from new starts versus switches. He also asked for confidence in United Therapeutics (UT) moving forward with a dry powder formulation for the second investigational molecule (1505) in their collaboration.

Answer

Michael Castagna (CEO) discussed new market research for Afrezza's pediatric opportunity, highlighting strong physician interest and potential for both switch and naive patients, with initial growth expected from switches. He outlined a methodical launch approach targeting key centers and community sales forces, with future consideration for consumer advertising. Regarding the UT collaboration, he confirmed that teams are progressing well on the second molecule (1505), and MannKind hopes it moves forward, but the decision rests with United Therapeutics.

Brandon Folkes from H.C. Wainwright & Co. asked about the current typical Afrezza patient profile, the impact of recent data on prescribing habits, and the strategy for expanding the sales footprint ahead of a potential pediatric launch.

Answer

CEO Michael Castagna noted a slight pivot towards Type 1 diabetes patients, with the 4-unit strength growing faster. Dominic Marasco, President of the Endocrine Business Unit, added that the strategy involves increasing unique prescribers and enhancing scientific engagement. For the pediatric launch, Castagna explained the expansion is necessary to increase share of voice and target academic centers with a dedicated team.

Brandon Folkes from Rodman & Renshaw Research asked about the potential for a manufacturing revenue component for MannKind if the TETON trial is successful and the timeline for Afrezza reaching a $200 million-plus sales run rate.

Answer

Executive Michael Castagna confirmed that MannKind is expanding its manufacturing capacity and would be prepared to handle increased supply orders for TYVASO DPI, which would boost collaboration services revenue. He projected that Afrezza could reach its growth targets by achieving a 10% market share in pediatrics within 12-24 months post-launch, which, combined with adult sales, would create a major inflection.

Brandon Folkes of Rodman & Renshaw inquired about Afrezza's growth drivers, including the breadth of prescribers, unaided awareness, physician anticipation for new data, and the future evolution of its commercial footprint.

Answer

Executive Michael Castagna explained that the current Afrezza strategy focuses on deepening relationships with existing prescribers following a sales force reduction, rather than broadening the base. He acknowledged a market headwind from endocrinologists shifting to weight-loss drugs. Looking ahead, the plan for 2025 is to deploy MSLs to educate the market on new INHALE-3 data to overcome historical safety perceptions and drive growth.

Brandon Folkes from H.C. Wainwright & Co. asked about the rollout status of the Vial Access Needle (VAN) for ZYNRELEF, specifically regarding P&T committee adoption and whether 2026 growth will be driven by sales detailing or broader hospital access. He also inquired about learnings from the VAN rollout that might inform the future prefilled syringe (PFS) launch strategy.

Answer

COO Mark Hensley explained that 2026 growth for ZYNRELEF will involve deepening penetration in existing formulary-approved hospital accounts and expanding through the CrossLink organization. He noted the VAN rollout was successful, largely eliminating preparation challenges, and there are no significant changes planned for the prefilled syringe launch strategy beyond inventory management.

Brandon Folkes asked about the progress of the Vial Access Needle (VAN) rollout, including P&T committee adoption and whether sales efforts or hospital access are the primary growth drivers for 2026. He also questioned if learnings from the VAN rollout would influence the prefilled syringe (PFS) launch strategy.

Answer

COO Mark Hensley explained that the growth strategy involves deepening penetration in existing formulary-approved accounts and expanding through CrossLink. He noted the VAN rollout was successful in removing preparation challenges and that the PFS launch would likely involve similar inventory management without significant strategic changes.

Brandon Folkes asked for the rationale behind the ZINRELEF salesforce reorganization and its effect on the CrossLink partnership. He also questioned the discrepancy between APONVI's 19% demand growth and 9% revenue growth.

Answer

CEO Craig Collard explained the salesforce was split into dedicated ZINRELEF and APONVI teams to better align representative skill sets with distinct call points (OR surgeons vs. hospital formularies). He noted the CrossLink partnership was enhanced with a new incentive program focused on specific accounts. Regarding APONVI, the gap between demand and revenue was attributed primarily to wholesaler inventory adjustments and a modest gross-to-net impact from new 340B hospital accounts, which is expected to normalize.

Brandon Folkes from Rodman & Renshaw requested further details on the drivers of the Q3 to Q4 revenue guidance, specifically the relative contributions from CINVANTI's rebound versus ZYNRELEF's VAN uptake, and the timing of the VAN's impact.

Answer

CEO Craig Collard clarified that the current ZYNRELEF uptick is driven by the CrossLink partnership, not the VAN, whose significant impact is not expected until Q1 2025 and beyond. He explained that the anticipated Q4 revenue strength is largely due to a CINVANTI rebound, resulting from new account wins and increased hospital business from the cross-portfolio sales initiative. He positioned CINVANTI as a foundational 'cash cow' funding growth in the acute care portfolio.

Brandon Folkes asked about Collegium Pharmaceutical's outlook on Jornay PM's peak sales ramp and the promotional sensitivity of Belbuca and Xtampza, particularly concerning the commercial infrastructure and investment hurdles if generics emerge.

Answer

Vikram Karnani, President and CEO, Collegium Pharmaceutical, indicated it's too early to project Jornay PM peak sales given ongoing sales force expansion impacts. Scott Dreyer, Chief Commercial Officer, Collegium Pharmaceutical, highlighted Belbuca and Xtampza's high promotional sensitivity and the efficiency of the 100-person sales team. Colleen Tupper, CFO, Collegium Pharmaceutical, added that investments in these brands would continue through potential LOE dates, with the ability to quickly moderate if an event occurs.

Brandon Folkes (H.C. Wainwright & Co.) asked Collegium Pharmaceutical to frame their thinking on Jornay PM's ramp to peak sales, specifically if a three-to-five-year timeline is anticipated. He also inquired about the promotional sensitivity of Belbuca and Xtampza given the Nucynta AG launch, and the company's strategy for commercial infrastructure investment in these pain products.

Answer

Vikram Karnani, President and CEO, indicated that Collegium Pharmaceutical needs more time to evaluate the impact of recent sales and marketing investments, including the expanded Jornay PM sales force, before providing peak sales projections or a ramp timeline. Scott Dreyer, Chief Commercial Officer, emphasized the high promotional sensitivity of Belbuca and Xtampza, supported by an efficient 100-person sales team. Colleen Tupper, CFO, added that investments in these brands would continue through potential loss of exclusivity dates, with flexibility to adjust, and noted Jornay's intellectual property extends to 2032.

Brandon Folkes asked about the expected contribution from the criminal justice system (CJS) opportunity to Indivior's 2026 SUBLOCADE guidance.

Answer

Chief Commercial Officer Patrick Barry stated that the CJS segment is viewed as a strong rebase business with growth potential, contributing to the mid-teen dispense unit growth guidance. He highlighted SUBLOCADE's differentiation as the only monthly long-acting injectable with rapid induction and existing prescriber familiarity as key factors supporting its role in CJS and overall LAI category growth.

Brandon Folkes asked about the expected contribution from the criminal justice system (CJS) opportunity to Indivior's 2026 SUBLOCADE guidance.

Answer

CCO Patrick Barry stated that the CJS segment is viewed as a strong opportunity and a rebase business with growth potential. He highlighted SUBLOCADE's differentiation as the only monthly long-acting injectable with rapid induction, making it familiar to prescribers. Mr. Barry confirmed that the CJS opportunity is expected to contribute to the mid-teens dispense unit growth guided for 2026, as Indivior aims to fuel and grow the overall LAI category.

Brandon Folkes asked for clarification on whether the 71% new patient start share for SUBLOCADE includes both weekly and monthly doses. He also inquired about the perceived advantage of weekly dosing in practice and the company's outlook for returning to top-line growth in 2026.

Answer

CCO Richard Simkin confirmed the 71% new start share is a total LAI look, equalizing weekly and monthly doses. He emphasized that efficacy is the key driver for prescribers over dosing flexibility and highlighted the potential competitive advantage of SUBLOCADE's upcoming rapid induction label for the monthly dose. CEO Mark Crossley expressed conviction in a return to growth in 2026, citing a stabilized market post-transition, a large unmet patient need, and SUBLOCADE's leadership position.

Brandon Folkes asked about any early signs, such as start forms or other signals, that would indicate a positive ELEVIDYS launch within the Japanese region.

Answer

President and Chief Executive Officer Doug Ingram stated that Sarepta is not in a position to provide specific launch information for Japan, deferring to their partner Roche. He expressed excitement based on Japan's sophisticated healthcare system, large population, and the potential benefit for many Duchenne patients.

Brandon Folkes inquired about the Japan launch of ELEVIDYS, asking if there are any early indicators, such as start forms or other signals, that provide confidence in a positive launch within that region.

Answer

Doug Ingram, President and Chief Executive Officer, stated that Sarepta is not in a position to provide specific launch details and deferred to Roche, their partner, for that information. He expressed general excitement about the launch, citing Japan's sophisticated healthcare system, large population, and the potential for many patients to benefit from the therapy.

Brandon Folkes asked for the expected completion timeline for the D-PLEX100 rolling NDA submission. He also requested clarification on the differences between the new Kynatrix platform and the original D-PLEX technology, and how much early-stage work is needed for Kynatrix, considering leverage from D-PLEX experience, to gauge the timing of new product development.

Answer

CEO Dikla Czaczkes Akselbrad stated that the NDA submission is expected by the end of the first quarter, with CMC and non-clinical modules submitted first, followed by the clinical module within a couple of months. She noted that Fast Track and Breakthrough Therapy Designations are expected to shorten the review to six months. COO Ori Warshavsky clarified that Kynatrix is an umbrella term for technological advancements and IP developed over several years, not a sudden shift. He explained that Kynatrix encompasses expanded capabilities like peptide release and intratumoral injection, building continuously on existing R&D efforts and leveraging the D-PLEX experience.

Brandon Folkes asked for color on the expected completion timeline for the D-PLEX100 rolling NDA submission. He also requested elaboration on the differences between the Kynatrix platform and the D-PLEX technology, how much early-stage work is needed for Kynatrix, and how much can be leveraged from D-PLEX experience, impacting the timing of new product development.

Answer

CEO Dikla Czaczkes Akselbrad stated that the NDA submission is expected by the end of the first quarter, with the CMC and non-clinical modules submitted first, followed by the clinical module within a couple of months. She noted that Fast Track and Breakthrough Therapy Designations support a shortened 6-month priority review. COO Ori Warshavsky clarified that Kynatrix is not a sudden shift but rather an umbrella term collecting several years of continuous work and IP development beyond the original FLEX platform. He explained that it allows for new IP on peptide release, intratumoral injection, and STING agonist partnerships, leveraging ongoing R&D efforts.

Asked about the factors that will determine the D-PLEX100 label language and the company's future capital allocation and development strategy, specifically regarding the timing of partnerships for pipeline assets.

Answer

The final label language will be heavily influenced by the Phase III efficacy data, including any impact on reintervention and mortality. The company plans a pre-NDA meeting with the FDA to discuss the label. Post-partnership for D-PLEX100, the strategy is to partner future pipeline assets at an earlier stage of development, allowing the partner to handle or co-fund the later, more expensive clinical development.

Brandon Folkes of H.C. Wainwright & Co. questioned the expected timeline from a potential December approval to the commercial launch of narsoplimab. He also asked about inventory levels and whether a significant inventory build, similar to a prior PDUFA cycle, should be modeled into R&D spending.

Answer

Gregory Demopulos, Founder, Chairman, CEO & President, stated that a December approval would lead to a Q1 launch. Nadia Dac, CCO, detailed that the field team would be trained and deployed immediately upon approval to drive awareness. David Borges, VP of Finance, Chief Accounting Officer & Treasurer, confirmed that Omeros has adequate supply for the first several years of launch, indicating a strong inventory position.

Brandon Folkes of Rodman & Renshaw inquired about the long-term strategic vision for Omeros, particularly its approach to commercialization versus partnerships for its broad pipeline, including narsoplimab and zaltenibart.

Answer

Chairman and CEO Gregory Demopulos outlined the strategy, stating Omeros plans to launch narsoplimab independently in the U.S. while seeking ex-U.S. partners for both narsoplimab and zaltenibart. He expressed high confidence in the approval prospects for both drugs, referencing the company's successful commercialization of Omidria. Dr. Demopulos emphasized that Omeros is moving back to being a commercial entity, supported by a deep pipeline that includes promising oncology and infectious disease programs.

Brandon Folkes of H.C. Wainwright & Co. asked about the medical specialties contributing most to new Myclifa patient enrollments in the U.S. and the dynamics of converting European Expanded Access Program (EAP) patients upon potential approval.

Answer

President and CEO Neil McFarlane highlighted the 26% quarter-over-quarter revenue growth for Myclifa, driven by strong patient pull-through from the 129 total enrollment forms. Chief Commercial Officer Joshua Schafer specified that prescribers include neurologists, pediatricians, medical geneticists, and an emerging group of psychiatrists. Regarding Europe, McFarlane noted the EAP has grown to 89 patients and expressed confidence that the durability of these patients on therapy bodes well for future conversions once country-by-country reimbursement is secured.

Brandon Folkes asked how management views Cortrophin's market share potential as the overall market expands and whether it could achieve equal or dominant share at its peak. He also requested more granularity on the factors influencing R&D spending going forward.

Answer

President, Director & CEO Nikhil Lalwani stated that the company's focus is on growing the overall ACTH market and getting Cortrophin to appropriate patients, rather than on a specific market share target. SVP & CFO Stephen Carey explained that R&D spending can be variable quarter-to-quarter, with Q2 being higher due to the New Day trial, but affirmed the company's commitment to continued investment in R&D to drive long-term growth.

Brandon Folkes from H.C. Wainwright & Co. inquired about the potential commercial impact of drug scheduling on prescribing habits in non-IPF ILD and whether negative results from the respiratory depression study could affect DEA scheduling.

Answer

Chief Commercial Officer Farrell Simon stated that based on market research, they do not anticipate scheduling to be a barrier for pulmonologists in the non-IPF ILD setting. Chief Development Officer James Cassella clarified that the respiratory study is for safety characterization and is not expected to impact DEA scheduling, which is driven by abuse liability potential.

Brandon Folkes of Rodman & Renshaw asked for the scientific rationale behind the potential for different placebo response rates in IPF chronic cough studies compared to RCC studies.

Answer

Executive Jennifer Good acknowledged that the reason for differing placebo rates isn't definitively known but speculated it could be due to the different types of clinical sites used. RCC studies are often conducted in highly specialized cough centers, whereas IPF trials may involve a broader range of general IPF centers. She confirmed that for future parallel-arm studies, they will conservatively plan for higher placebo rates.

Brandon Folkes from Rodman & Renshaw requested an update on the timing for the TIDAL respiratory physiology study and sought confirmation of the company's commitment to the study, especially with the arrival of the new Chief Development Officer.

Answer

CEO Jennifer Good confirmed the TIDAL study is currently enrolling and the data is needed for the end-of-Phase II meeting for IPF in the second half of 2025. The study's purpose is to inform the Phase III patient population definition, specifically regarding patients with sleep-disordered breathing. CDO Dr. James Cassella affirmed he has no different thoughts and sees it as an informative study for future decisions.

Brandon Folkes asked about the current satisfaction level of high-volume prescribers with varenicline and the amount of education needed to shift their prescribing habits. He also inquired about how the commercial approach for a future vaping indication would differ from smoking cessation, given the younger patient demographic.

Answer

Chief Commercial Officer Jaime Xinos stated that physician satisfaction with varenicline is low, with data showing high failure rates, making them receptive to a new, more effective option. CEO Richard A. Stewart noted the company's digital-first strategy will be crucial for awareness. For vaping, Xinos explained that while the physician target is similar (primary care), the consumer strategy will be more nuanced, leveraging digital health apps, tech partnerships, and a broader range of social media channels to engage the younger audience.

Brandon Folkes of Rodman & Renshaw asked about the operating expense footprint within the 2025 guidance and how it is expected to evolve beyond 2025. He also questioned how Emergent plans to position the newly acquired KLOXXADO relative to NARCAN and whether its growth will be driven primarily by distribution synergies.

Answer

EVP and CFO Richard Lindahl stated that the Q4 2024 operating expense run rate reflects the full benefit of recent cost-saving actions and that the company will continue to seek further efficiencies. President and CEO Joseph Papa added that these expense reductions are a key factor in the projected margin improvements for 2025. Regarding KLOXXADO, Papa explained it will leverage the NARCANDirect distribution platform to provide customers with an alternative for treating high-potency fentanyl overdoses, complementing NARCAN and offering first responders greater flexibility.

Brandon Folkes of Cantor Fitzgerald inquired about the long-term gross margin outlook for NARCAN and the company's strategy for pursuing new growth opportunities, including both internal development and external business development.

Answer

EVP, Chief Financial Officer and Treasurer Rich Lindahl stated that NARCAN's gross margin is stabilizing around the current level (50% in Q3) due to price reductions and ongoing cost improvement efforts. President and CEO Joe Papa added that future growth will come from internal opportunities like Ebanga, TEMBEXA, and NARCAN line extensions (e.g., workplace kits), as well as targeted business development deals that leverage their existing first responder and government channels.

Brandon Folkes of Rodman & Renshaw sought clarification on whether Q1 revenue could decline sequentially from Q4, given the commentary about positive trends impacting revenue starting in Q2. He also asked for an update on the pediatric launch and its anticipated contribution in 2025.

Answer

Executive Thomas McHugh did not provide specific quarterly guidance but reiterated confidence in the full-year forecast of $240M-$260M, while acknowledging the significant gross-to-net headwinds in Q1 that affect all industry players. Executive Gregory Divis described the pediatric launch as a focus area with positive patient stories but noted it represents a small portion of the overall market due to long diagnosis timelines. He confirmed Avadel is actively pursuing this segment.

Brandon Folkes of Rodman & Renshaw asked about the consistency of patient types being treated with DefenCath across different providers and whether any variability presents an opportunity for education and expansion. He also inquired about the outlook for gross margin, noting its strength in the first full quarter of sales.

Answer

CEO Joseph Todisco responded that there is variability in how customers triage patients, with some focusing on benefits verification and others on high-risk status first. He confirmed this variability presents a significant growth opportunity to expand usage into new patient cohorts. Regarding margins, Todisco explained that while initial margins are high partly due to inventory being previously expensed as R&D, he expects the gross margin to remain healthy through 2025 due to the favorable cost of goods relative to the net selling price.

Brandon Folkes of Cantor Fitzgerald requested an update on the performance and progress of Qbrexza. He also inquired about the DFD-29 opportunity, specifically the required commercial investment to achieve the stated $100 million peak sales target, whether that figure was U.S. or global, and if the company had quantified the commercial opportunity for its anti-itch product.

Answer

CEO Claude Maraoui detailed Qbrexza's strong prescription growth, projecting a full-year increase of over 20% for 2022 and a potential revenue run rate of $28-30 million, with further growth expected. General Counsel Ramsey Alloush clarified the $100 million DFD-29 sales estimate is for the U.S. market only, with additional ex-U.S. opportunities available. CFO Ernie De Paolantonio noted there will be incremental commercial spending for DFD-29, similar to other launches, but did not provide specific guidance. The commercial opportunity for the anti-itch product was not detailed.

Brandon Folkes from Cantor Fitzgerald inquired about the DFD-29 clinical program, asking what data would be necessary for product differentiation and how the current patient enrollment pace compares to the company's initial projections.

Answer

Claude Maraoui, Co-Founder President and CEO, confirmed the program is on track. Dr. Srinivas Sidgiddi, VP of Clinical Development and Medical Affairs, elaborated that while there's a minor regulatory delay in Europe, overall enrollment is within planned buffers. He stated differentiation will be based on showing significant improvement in inflammatory lesions and erythema compared to existing treatments.

Brandon Folkes from Cantor Fitzgerald inquired about the sales impact of the commercial team reduction, the gross-to-net outlook for 2022 compared to 2021, and the expected pace of the $50 million in operational cost savings.

Answer

President and Chief Commercial Officer Rick Scruggs explained that a comprehensive analysis led to territory consolidation to maintain revenue targets. CFO Micha Ben-Chorin stated that gross-to-net has stabilized but is slightly higher than last year due to increased coverage, and confirmed the $50 million in savings would be realized at a relatively even pace over the next 18 months.

Brandon Folkes from Cantor Fitzgerald inquired about the market size of the opaganib opportunity in South Korea, whether additional trials would be required there, the potential for more partnerships before new trials, and the focus for in-licensing new assets.

Answer

CEO Dror Ben-Asher stated that RedHill is focused on in-licensing synergistic, FDA-approved commercial assets to leverage its salesforce. COO Gilead Raday added that they are working with their South Korean partner on regulatory approaches tailored to that territory. Dror Ben-Asher highlighted the significant market size, noting approximately 4 million new infections in South Korea in the first half of March 2022 alone, and confirmed their partner is optimistic about the regulatory path.

Brandon Folkes of Cantor Fitzgerald asked about the regulatory path for opaganib, questioning if the EMA would be the most receptive and lead agency. He also inquired about the rationale for expanding the RHB-204 Phase 3 trial to new territories and whether to expect further improvements in Talicia's payer coverage.

Answer

CEO Dror Ben-Asher explained that while the EMA is expected to provide the first feedback on opaganib, it doesn't necessarily mean it will be the fastest path to market, as the company is pursuing approvals in many other countries. He confirmed the RHB-204 trial expansion is to accelerate enrollment. Bob Gilkin, SVP of Market Access, added that while Talicia's coverage is excellent, the team is committed to securing more wins in 2022, citing their success with Movantik.