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    Douglas Tsao • H.C. Wainwright & Co., LLC

    Douglas Tsao's questions to Evotec SE (EVO) leadership

    Douglas Tsao's questions to Evotec SE (EVO) leadership • Q2 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. requested more color on the recent increase in change orders, asking if there was a thematic reason behind them.

    Answer

    CEO Christian Wojczewski clarified that the increase was not a systematic trend and was primarily driven by scientific reasons or specific customers reallocating funds to later-stage projects. He emphasized there was no discernible pattern and that the trend had already reversed at the beginning of the third quarter.

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    Douglas Tsao's questions to Evotec SE (EVO) leadership • Q1 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. asked if potential cuts to U.S. NIH funding could create new opportunities for Evotec in early-stage research. He also followed up by asking if discussions around potential U.S.-China tariffs were making Evotec's U.S.-based Just Biologics manufacturing site more attractive to clients.

    Answer

    CEO Christian Wojczewski responded that Evotec's direct exposure to NIH funding is limited, so no direct impact is expected, though the company is prepared for market shifts. On the topic of tariffs, he noted that the Just Biologics business is experiencing strong inbound demand regardless of the specific trigger, be it technology or geopolitics. He stated that while clients are cautious amid the dynamic environment, there is sufficient activity to be confident in the business's continued growth.

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    Douglas Tsao's questions to Evotec SE (EVO) leadership • Q1 2025

    Question

    Douglas Tsao asked if potential cuts to U.S. NIH funding could create new opportunities for Evotec. He also inquired if the Just Biologics business is seeing increased interest from clients looking to shift manufacturing to the U.S. due to potential tariffs.

    Answer

    CEO Christian Wojczewski stated that Evotec's direct exposure to NIH funding is limited, but the company is prepared with its U.S. footprint. Regarding Just Biologics, he confirmed strong inbound activity but noted the market is too dynamic for clients to make definitive decisions based on tariffs alone, though the business continues to grow rapidly.

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    Douglas Tsao's questions to Roivant Sciences Ltd (ROIV) leadership

    Douglas Tsao's questions to Roivant Sciences Ltd (ROIV) leadership • Q1 2026

    Question

    Douglas Tsao asked about the steroid taper in the DM study, specifically the timing goal for patients to discontinue steroids. He also questioned the expectations for the 15mg dose of brepocitinib, given that most positive data has come from the 30mg dose.

    Answer

    CEO Matt Gline explained that the mandatory steroid taper begins at week 12 and concludes at week 36, with the goal of getting patients to the lowest possible dose by the end of that period. He stated that the 15mg dose was included primarily for regulatory purposes and that the company's focus is on the 30mg dose, which is the basis for the primary endpoint.

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    Douglas Tsao's questions to Roivant Sciences Ltd (ROIV) leadership • Q4 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. asked about Roivant's pricing strategy for its FcRn franchise, considering the increasing competition and the mix of orphan and more prevalent indications like Graves' disease.

    Answer

    CEO & Director Matt Gline expressed confidence in their pricing flexibility, comparing the current FcRn landscape to the early days of TNF inhibitors. He noted that many FcRn-addressable diseases have high unmet needs and that existing pricing for other therapies in these areas is generally compatible with current FcRn pricing. He stated that final decisions will depend on launch order and data quality, but the overall portfolio fits well into a cohesive promotional model.

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    Douglas Tsao's questions to Roivant Sciences Ltd (ROIV) leadership • Q3 2025

    Question

    Douglas Tsao inquired about the anticipated pace for unveiling new brepocitinib indications and asked if its potential scope could rival Immunovant's target of over ten indications.

    Answer

    CEO Matthew Gline stated that Roivant is actively evaluating other indications for brepocitinib and will unveil them as they become ready, not at a predetermined pace. While not committing to a specific number, he agreed there is a long list of potential orphan inflammatory indications where brepo could benefit patients. Gline emphasized the focus is on picking the right spots based on competitive dynamics, mechanism fit, and operational capacity to ensure high-quality execution.

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    Douglas Tsao's questions to Roivant Sciences Ltd (ROIV) leadership • Q2 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. asked for clarification on the uveitis trial protocol regarding patient crossover to brepocitinib upon failure. He also inquired about Roivant's broader business development strategy and whether the move into respiratory signals a new therapeutic focus.

    Answer

    CEO Matt Gline confirmed that patients who experience treatment failure automatically switch to open-label brepocitinib. On business development, he described the strategy as flexible and opportunistic, stating the company is 'ruthlessly focused' on the best assets regardless of therapeutic area, likening Roivant to the 'excess dough outside of other people's cookie cutters.'

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    Douglas Tsao's questions to Crinetics Pharmaceuticals Inc (CRNX) leadership

    Douglas Tsao's questions to Crinetics Pharmaceuticals Inc (CRNX) leadership • Q2 2025

    Question

    Douglas Tsao of H.C. Wainwright & Co. asked if the glucocorticoid (GC) tapering protocol in Part B of the pediatric BALANCE CAH study will replicate the protocol used in the adult COMCAH study.

    Answer

    Chief Medical & Development Officer Dana Pizzuti clarified that while the goal is the same—to demonstrate A4 reduction and GC tapering—the pediatric protocol is not exactly the same. She explained that there is more caution and flexibility in the pediatric setting for how investigators carefully titrate GC doses down. The objective is to get patients to normal A4 and then reduce GCs, with a requirement for a stable GC dose for the final four weeks of the 28-week trial.

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    Douglas Tsao's questions to Crinetics Pharmaceuticals Inc (CRNX) leadership • Q1 2025

    Question

    Douglas Tsao followed up on the CAH pediatric program, asking if it would be an adaptive design to avoid multiple studies and whether the primary endpoint would be the same as in the adult trial.

    Answer

    Dr. R. Struthers, CEO, and Dr. Alan Krasner, Chief Endocrinologist, responded. Struthers confirmed the study is a seamless Phase II/III design, not two separate trials. Krasner added that the ultimate treatment goal—normalizing both GCs and A4 levels—is the same for pediatric and adult patients, so he anticipates a very similar endpoint.

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    Douglas Tsao's questions to Crinetics Pharmaceuticals Inc (CRNX) leadership • Q3 2024

    Question

    Douglas Tsao asked if the TSH antagonist program could provide compelling proof-of-mechanism data in a Phase I study, similar to past Crinetics programs, and how that might inform the initial development strategy between Graves' disease and Thyroid Eye Disease (TED).

    Answer

    Chief Endocrinologist Dr. Alan Krasner confirmed that the TSH antagonist is well-suited for a Phase I proof-of-concept study. He explained that biomarkers like thyroid hormone levels (T4) could provide rapid evidence of hitting the pharmacologic target, although measuring efficacy in TED would require a longer timeframe.

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    Douglas Tsao's questions to Arcutis Biotherapeutics Inc (ARQT) leadership

    Douglas Tsao's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q2 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. inquired about the adoption dynamics among physicians, specifically how long it takes for them to begin prescribing Zareve for multiple indications and what factors drive this behavior. He also asked why some prescribers might still be using it for only a single indication.

    Answer

    Chief Commercial Officer Todd Edwards explained that physicians who have prior experience with Zareve tend to adopt new indications and formulations rapidly, as it creates prescribing efficiencies. He stated that prescribers who use Zareve for only one indication are the exception, and this is typically due to practice-specific patient populations. The commercial team continues to educate all prescribers on the full portfolio.

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    Douglas Tsao's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q1 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. asked about the expected adoption trajectory for ZORYVE foam's upcoming scalp and body psoriasis indication, comparing it to the rapid uptake seen with the seborrheic dermatitis launch, and inquired about its promotional sensitivity.

    Answer

    CEO Frank Watanabe cautioned against expecting a repeat of the 'vertiginous' uptake seen with the seborrheic dermatitis launch, which he described as a unique situation with huge unmet need. For scalp psoriasis, while ZORYVE is a very competitive option, other treatments exist. He expects the new indication will contribute to a continued, steady growth trajectory rather than a sudden spike. He also noted that the indication is highly promotionally sensitive and that educating clinicians on the compelling efficacy and safety data will be important for driving incremental upside and streamlining reimbursement.

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    Douglas Tsao's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q4 2024

    Question

    Douglas Tsao of H.C. Wainwright & Co. asked about the reimbursement dynamic, questioning how the clinical desire to move away from topical steroids reconciles with payers who may still require them as a first-line therapy, and whether ZORYVE could become a first-line treatment.

    Answer

    President and CEO Frank Watanabe explained that the steroid step-edit is largely irrelevant for their target market of 16 million patients who are already on steroids and have thus met the requirement. Chief Medical Officer Patrick Burnett added that clinical practice is evolving to use steroids for acute flares and non-steroidals like ZORYVE for chronic management, a paradigm that aligns well with current payer utilization criteria.

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    Douglas Tsao's questions to Praxis Precision Medicines Inc (PRAX) leadership

    Douglas Tsao's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q2 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. asked if the increasing efficacy over time is a unique function of the drug's sodium channel interaction, about differentiating side effects from the drug versus background therapies, and if the mood benefits were anecdotal.

    Answer

    CSO Steven Petrou linked the effect to the molecule's unique biophysical profile. President & CEO Marcio Souza noted AEs were reduced when background drugs were tapered and confirmed mood benefits were initially anecdotal, prompting the addition of a formal mood endpoint in the POWER-two study.

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    Douglas Tsao's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q3 2024

    Question

    Douglas Tsao asked for confirmation on the patient randomization pace, more details on the development plan for Vormatrigine in pain, and clarification on the elsunersen development path, including the potential for using higher doses.

    Answer

    CEO Marcio Souza confirmed the 20-30 patient per week randomization pace is comfortable. For Vormatrigine in pain, he said work is underway to assess pharmacology and competitive positioning. For elsunersen, the Brazil study is exploring different doses to inform the global program, and the company remains open to using higher doses if the science supports it.

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    Douglas Tsao's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q2 2024

    Question

    Douglas Tsao questioned why the RADIANT study wasn't designed exclusively for generalized epilepsy patients given the high interest, and asked about the rationale for the different dosing strategies between the RADIANT and POWER studies.

    Answer

    CEO Marcio Souza responded that RADIANT's design provides flexibility to first understand the drug's impact in both focal and generalized epilepsy, which could inform a future dedicated study. He explained the dosing difference is strategic: RADIANT's higher starting dose aims to maximize efficacy quickly, while the POWER studies' titration schedule is designed to gather data at different concentrations to inform regulatory discussions and labeling.

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    Douglas Tsao's questions to argenx SE (ARGX) leadership

    Douglas Tsao's questions to argenx SE (ARGX) leadership • Q2 2025

    Question

    Douglas Tsao from H.C. Wainwright & Co. relayed physician feedback about challenges in securing patient access to the prefilled syringe (PFS) and asked if this was due to isolated issues or if demand was outstripping supply.

    Answer

    COO Karen Massey acknowledged that some access hurdles are normal in the first quarter of any launch while payer policies are established, but noted the team is ahead of schedule, having already secured coverage for 70% of commercial lives. She stated that general feedback is very positive regarding the speed of access. CFO Karl Gubitz added definitively that the issue is not related to inventory, as supply is sufficient.

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    Douglas Tsao's questions to argenx SE (ARGX) leadership • Q4 2024

    Question

    Douglas Tsao asked how a potential approval in ocular MG might affect the overall MG treatment paradigm and whether it could be viewed as a disease-modifying therapy by encouraging earlier treatment.

    Answer

    Chief Operating Officer Karen Massey embraced the 'disease-modifying' framing, stating the company's strategy is that earlier treatment leads to better outcomes. She noted that with 80% of ocular MG patients generalizing, there is potential to show a delay in generalization with real-world data over time, which would be transformative.

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    Douglas Tsao's questions to argenx SE (ARGX) leadership • Q1 2024

    Question

    Douglas Tsao asked where the prefilled syringe (PFS) is expected to ultimately fit within the VYVGART portfolio and if it has the potential to become the dominant formulation.

    Answer

    CEO Tim Van Hauwermeiren positioned the PFS as the 'closing piece' in a complete product offering. He explained that the IV formulation (Medicare Part B) will remain important for some, while the PFS with self-administration will primarily target the Medicare Part D channel, allowing Argenx to serve the preferences of different patient and physician segments comprehensively.

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    Douglas Tsao's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Douglas Tsao's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q2 2025

    Question

    Douglas Tsao of H.C. Wainwright asked about the consistency of free goods utilization across practices and whether Apellis is seeing more patient referrals from outside the existing specialist base.

    Answer

    EVP David Acheson highlighted strong underlying demand and the work of reimbursement teams to educate offices on benefit design. He confirmed that referral programs are working but also noted that a significant opportunity (~50% of the market) still resides within the existing patient populations of treating retina specialists.

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    Douglas Tsao's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q1 2025

    Question

    Douglas Tsao asked for more detail on the specific steps Apellis is taking to mitigate the co-pay impact and whether SYFOVRE's every-other-month dosing provides a greater advantage in the current environment.

    Answer

    Executive David Acheson confirmed the dosing flexibility is a key advantage, as fewer annual co-pays are easier for patients. He elaborated on mitigation tactics, explaining that the reimbursement team is educating offices on patient benefit designs to avoid unnecessary use of foundation support. Additionally, the Apellis Assist program helps offices identify when a patient's out-of-pocket maximum is met, enabling a switch to commercial treatment.

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    Douglas Tsao's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q4 2024

    Question

    Douglas Tsao of H.C. Wainwright asked about the biological rationale for the next-generation SYFOVRE combination therapy and the potential impact of the Medicare redesign.

    Answer

    CEO Dr. Cedric Francois confirmed the rationale for the combo therapy is to better protect RPE cells by lowering systemic C3 from the choroidal side, complementing SYFOVRE's strong effect on photoreceptors. EVP of Commercial David Acheson stated that quantifying the impact of the Medicare redesign is challenging at this time.

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    Douglas Tsao's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q3 2024

    Question

    Douglas Tsao of H.C. Wainwright & Co. asked for more detail on the specific messaging that resonated with physicians to drive the rebound in market share and which points might have been previously misunderstood.

    Answer

    COO Adam Townsend explained that they simplified their efficacy messages to focus on key differentiators like up to 42% lesion growth reduction, flexible dosing, and a well-documented safety profile. He stressed that efficacy is the primary driver. CMO Dr. Caroline Baumal added that the company's alignment with the ASRS and the growing body of real-world data have also significantly increased physician confidence.

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    Douglas Tsao's questions to Evolus Inc (EOLS) leadership

    Douglas Tsao's questions to Evolus Inc (EOLS) leadership • Q1 2025

    Question

    Douglas Tsao asked for details on the broader market softness, questioning which segments are most affected and how the weakness is manifesting—whether it's fewer new patient starts or existing patients extending the time between treatments.

    Answer

    CEO David Moatazedi responded that the slowdown is consistently heard as a slight slowing in clinic schedules, primarily driven by fewer new patients entering the category. He noted some early signs of patients extending treatment intervals, but this is a smaller factor. CFO Sandra Beaver added that the continued strong adoption of the loyalty program is a positive indicator of underlying patient demand, suggesting that while wallet-conscious, consumers remain engaged.

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    Douglas Tsao's questions to Evolus Inc (EOLS) leadership • Q4 2024

    Question

    Douglas Tsao asked about the process for accounts to begin using the new Evolysse fillers, specifically regarding account prioritization, and whether the launch would prompt changes to customer loyalty programs.

    Answer

    CEO David Moatazedi explained that the company will leverage its extensive training platform to go broad and fast with the launch, rather than prioritizing only top-tier accounts. He confirmed that Evolysse will be integrated into existing loyalty programs immediately in Q2 for co-branded media benefits, with consumer rewards for combined treatments to be introduced shortly thereafter, ahead of Q3.

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    Douglas Tsao's questions to Evolus Inc (EOLS) leadership • Q3 2024

    Question

    Douglas Tsao of H.C. Wainwright & Co. asked for the reason behind narrowing the revenue guidance by lowering the upper end, and also inquired about the competitive environment, including any proactive steps being taken in anticipation of a new market entrant.

    Answer

    CFO Sandra Beaver explained that narrowing guidance is a standard Q4 practice for providing clarity and not a sign of concern. President and CEO David Moatazedi added that the competitive landscape has been consistent and that Evolus is well-prepared for new entrants, expressing confidence in their own differentiated strategy and sustained growth.

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    Douglas Tsao's questions to Alkermes Plc (ALKS) leadership

    Douglas Tsao's questions to Alkermes Plc (ALKS) leadership • Q1 2025

    Question

    Douglas Tsao asked about the decision-making process for advancing Project Saturn molecules into new indications and whether the selection of an indication is dependent on the pharmacokinetic profiles observed in early human studies.

    Answer

    CEO Richard Pops and COO Blair Jackson confirmed that they expect to advance multiple drugs into different therapeutic areas under Project Saturn. They explained that the molecules have distinct properties, and the data from initial SAD/MAD studies, combined with preclinical work, will be crucial for matching the best agent to the most appropriate indication.

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    Douglas Tsao's questions to Alkermes Plc (ALKS) leadership • Q4 2024

    Question

    Douglas Tsao asked for perspective on Alkermes's competitive advantages in the orexin space, focusing on chemistry challenges and the durability of its first-mover advantage, and whether to be cautious of competitors' preclinical potency data.

    Answer

    CEO Richard Pops detailed the high difficulty of developing an effective oral orexin agonist. He argued Alkermes's advantage lies in having positive data across NT1, NT2, and IH with a flexible, adjacent dosing range. He agreed that preclinical data is insufficient, stating that potency is table stakes and that tolerability and efficacy can only be truly assessed in patients.

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    Douglas Tsao's questions to Alkermes Plc (ALKS) leadership • Q3 2024

    Question

    Douglas Tsao asked what indications would be pursued for the second-generation orexin molecules based on Phase 1 data, and sought more detail on why a potential olanzapine long-acting injectable would not impact LYBALVI.

    Answer

    CEO Richard Pops indicated that the company has a good sense of where to take the next-gen orexin agents but will formally commit after completing initial human studies. CCO Todd Nichols explained that LYBALVI is insulated from a potential olanzapine LAI because the rate-limiting factor for any olanzapine therapy is weight gain. Since LYBALVI solves this issue, it has become the standard of care for olanzapine-based therapy, a position an LAI is unlikely to disrupt without also addressing weight mitigation.

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    Douglas Tsao's questions to Xenon Pharmaceuticals Inc (XENE) leadership

    Douglas Tsao's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q4 2024

    Question

    Douglas Tsao from H.C. Wainwright asked for details on the endpoints used to measure mood benefits in the focal onset seizure (FOS) study and whether they could appear on the label. He also inquired about the outlook for R&D spending.

    Answer

    CEO Ian Mortimer stated it was premature to comment on the label, emphasizing that mood endpoints are exploratory and not powered for statistical significance. CMO Dr. Chris Kenney specified that the GAD-7 and Beck Depression Inventory scales are being used to assess anxiety and depression. CFO Sherry Aulin confirmed the cash runway into 2027 accounts for a 'meaningful increase' in R&D spending in 2025-2026, driven by multiple Phase III trials and advancing preclinical assets.

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