Eduardo Martinez-Montes

Eduardo Martinez-Montes asked about the anticipated timeline for the 503A pharmacy to achieve 50-state coverage and the expected margin impact once fully scaled. He also inquired about any market research or visibility regarding the potential bump in patient uptake for oral obesity products, specifically from patients who avoid needles.

Answer

CEO Justin Schreiber stated that the 503A pharmacy is expected to be licensed in 35 states within the next 60-90 days, with the remaining 15 states (excluding one or two difficult ones like California) following in another 30-90 days. He emphasized that owning and operating the 503A compounding pharmacy is a "big competitive advantage" for driving down COGS, controlling the patient experience, and making personalized medications more accessible. Regarding oral obesity products, Schreiber believes the impact will be "big," potentially expanding the market by 25-50%, especially among older demographics, as many individuals are waiting for an oral option. He acknowledged that putting an exact number on the demand is difficult but anticipates "massive demand."

Eduardo Martinez-Montes from H.C. Wainwright & Co. asked for a breakdown of subscribers by business segment, details on customer attrition rates, and management's view on LifeMD's key competitive differentiators.

Answer

CFO Marc Benathen estimated that weight management accounts for 30-35% of active subscribers and stated that the company historically retains about one-third of a customer cohort after 12 months. CEO Justin Schreiber highlighted the company's integrated medical and pharmacy benefits infrastructure and its unique ability to operate a high-quality, 50-state synchronous care platform at scale as key differentiators.

Eduardo Martinez-Montes, on behalf of Yi Chen, asked about potential catalysts in 2025 related to remote patient monitoring with wearables and any new developments in the at-home diagnostics space.

Answer

Executive Justin Schreiber responded that while integrating wearables into the LifeMD app is a priority, a broader remote patient monitoring (RPM) offering is not on the 2025 roadmap. In at-home diagnostics, he stated the company is actively evaluating new collection devices but finds current options limited for comprehensive panels. LifeMD is working with in-home phlebotomy partners to improve convenience for patients needing lab work for programs like HRT, and sees significant future innovation in the space.

The analyst inquired about the specific timelines for clinical trials and regulatory submissions for the company's four key diagnostic tests. He also asked about the prioritization of these submissions and the company's strategy for commercial launch, including target markets, timing, and distribution plans.

Answer

Management stated that all four tests (COVID-19, multiplex, TB, HPV) are expected to enter clinical trials within the 2025 calendar year, starting with the COVID-19 test. They anticipate a US commercial launch for the COVID-19 test around mid-2026, following FDA submission and review. The commercial strategy for the US includes point-of-care settings, pharmacies, and home use, while the TB and HPV tests are targeted for international markets like India and Africa.

Eduardo Martinez-Montes of H.C. Wainwright & Co., LLC inquired about the specific timelines for Co-Diagnostics' four key diagnostic tests, including the order of clinical trial completion, regulatory submission priorities, and the expected commercial launch schedule for the Kodiak PCR platform.

Answer

CEO Dwight Egan stated that clinical trials for all four tests (COVID-19, respiratory four-plex, TB, and HPV) are on track to begin in 2025, with COVID-19 expected first. He anticipates submitting for FDA 510(k) clearance for the COVID test upon trial completion, targeting a potential mid-2026 commercial launch. Egan detailed the US go-to-market strategy, focusing on point-of-care settings like physician offices, clinics, and pharmacies, while also seeking home-use clearance. For international markets, the focus is on primary care centers in India and Africa for TB and HPV tests.

Eduardo Martinez-Montes, representing Ram Selvaraju of H.C. Wainwright & Co., LLC, asked about the FDA's proactiveness in enforcing guidance against substituting PEDMARK with compounded versions. He also inquired about the EU launch timeline with Norgene and visibility on German pricing.

Answer

CEO Jeff Hackman affirmed that the FDA's prior statement against compounding remains a key message, particularly in pediatric academic centers, and noted that compounding is not a significant issue in the AYA community setting. CFO Robert Andrade added that the medical team is effectively communicating PEDMARK's unique value. Regarding the EU, Andrade confirmed Norgene's launch is underway in the UK and Germany, with expansion into the rest of the EU5 and Nordic countries expected in late 2024 and early 2025. He noted that UK pricing exceeded expectations, which is a positive indicator for the upcoming German pricing milestone.

Eduardo Martinez-Montes of H.C. Wainwright & Co., LLC asked for more details on the 17-year Japanese follow-up study, specifically the patient population and why its recurrence rate was lower than in US studies, and questioned if the company's current cash position was sufficient to fund operations through FDA clearance.

Answer

CEO Eyal Shamir explained the Japanese study's 99% recurrence-free rate was in a similar low-risk patient population but noted the standard of care in Japan includes whole breast radiation for all patients, contributing to the better results. CFO & COO Ronen Tsimerman stated that the company's current funding is sufficient to reach the FDA authorization milestone, and the full cash need will be re-evaluated after the post-marketing study budget is finalized.

Asked about the impact of new U.S. tariffs on ProSense, plans for expanding the sales team after receiving marketing authorization, and the company's commercial strategies for pricing and sales (e.g., outright purchase vs. leases).

Answer

The company confirmed they were initially affected by U.S. tariffs but noted there is a current freeze. They plan to expand the sales team significantly upon receiving marketing authorization. Their commercial strategy will involve a mix of placing consoles with probe commitments and selling the consoles directly, estimated at a 60/40 or 50/50 split.

Speaking on behalf of Yi Chen, Eduardo Martinez-Montes from H.C. Wainwright & Co., LLC asked about the potential impact of new U.S. tariffs on ProSense, plans for sales team expansion post-approval, and the company's commercial strategy regarding pricing and sales models.

Answer

CFO & COO Ronen Tsimerman stated that while the company was initially affected by U.S. tariffs, there is currently a 'freeze' on them. CEO Eyal Shamir confirmed plans to significantly expand the U.S. sales team following marketing authorization. Shamir also detailed the commercial strategy, anticipating a 50/50 or 60/40 split between placing consoles with probe purchase commitments and selling the consoles outright.

Eduardo Martinez-Montes of H.C. Wainwright & Co., LLC asked for more detail on the specific product growth drivers within the Surgical segment, requested figures on new surgeon adoption, and questioned the primary rationale for seeking strategic alternatives for the Tissue Health Plus (THP) segment.

Answer

Seth Yon, President of Commercial, identified Celerate and BioSurg as the primary growth drivers in the soft tissue category and noted expansion into new surgical specialties, though he did not provide specific surgeon adoption figures. CEO Ron Nixon explained that after significant investment in THP, the company believes it is the right time to seek strategic partners to help fund the next phase of growth.

Eduardo Martinez-Montes of H.C. Wainwright & Co., LLC asked for details on the commercial infrastructure needed to reach RRP-treating physicians and questioned if data exists to support efficacy in the confirmatory trial's patient population, which requires fewer prior surgeries.

Answer

Chief Commercial Officer Steve Egge explained that the market is concentrated among 300-400 laryngologists, allowing for a small, efficient commercial team. Chief Medical Officer Dr. Michael Sumner confirmed the original trial included patients with a range of 2 to 8 prior surgeries and showed benefit across the spectrum. CEO Dr. Jacqueline Shea added that targeting patients with 2+ surgeries is a strategic choice to intervene earlier.

Eduardo Martinez-Montes of H.C. Wainwright & Co., LLC asked if the Phase III trial would specifically enroll a certain percentage of patients with sarcopenia or osteoporosis, and if it would monitor clinical outcomes like hospitalizations or fractures.

Answer

Chairman, President & CEO, Mitchell Steiner, clarified that the trial focuses on the >60 age group because GLP-1s induce muscle loss, making this population highly informative, rather than pre-screening for sarcopenia. Chief Scientific Officer, Gary Barnette, added that the expected high proportion of female participants (~70%) will provide sufficient numbers to evaluate bone mineral density. He also confirmed that outcomes like falls and fractures will be monitored as adverse events of special interest.

Eduardo Martinez-Montes of H.C. Wainwright & Co. asked for details on the new distribution partnership with Radiation Oncology Systems (ROS) and its expected impact on sales. He also inquired about the timeline for international expansion following the MD SAP certification and whether management was seeing any broader macroeconomic softness in capital equipment spending.

Answer

CEO Joseph Sardano and President Michael Sardano highlighted their strong, long-standing relationship with ROS and expect the partnership to yield sales results before year-end. Michael Sardano noted that the recent MD SAP certification provides immediate access to new markets like Japan, Brazil, and Australia, with a trip to Asia planned for the end of the month to formalize relationships. They stated the current market pause is specific to SRT reimbursement uncertainty, not macro softness, and that the FDA program continues to show strong growth, with treatment volume up 27% over Q1.

Asked for details on the new ROS distribution partnership, a timeline for new international agreements following the MD SAP certification, and whether there is any broader macro-level softness in capital equipment spending.

Answer

The company expects the ROS partnership to yield sales results before year-end, leveraging ROS's strong hospital relationships. International expansion is expected to be rapid, with immediate activities planned in Asia (Japan, Taiwan) followed by South America. The current sales pause is viewed as specific to the SRT reimbursement uncertainty, not a broader market softness, and the company's FDA program continues to show strong growth in patient volume.

Eduardo Martinez-Montes, on behalf of Raghuram Selvaraju, asked for a timeline on when KLOXXADO would be available through the NARCANDirect system. He also inquired about the status of the MOSA trial for mpox and whether to expect any near-term contract adjustments or option exercises for other Biodefense products.

Answer

President and CEO Joseph Papa stated that Emergent is working through the logistics and expects KLOXXADO to be integrated into its ordering systems within the next 30 to 60 days. On mpox, Papa focused on the ongoing work with the World Health Organization for an Emergency Use Listing for ACAM2000. EVP and CFO Richard Lindahl addressed the Biodefense contracts, stating that the pattern of option exercises from 2024 is a good indicator for 2025, with the U.S. government expected to continue executing against existing contracts throughout the year.

Eduardo Martinez-Montes inquired about visibility into client catalysts for 2025, the potential impact from government grant funding freezes, and the strategy for bundling the evo and Thaw platforms.

Answer

CEO Roderick de Greef noted visibility into approximately eight client milestones (e.g., approvals, expansions) for 2025 and sees minimal risk from funding freezes, as direct customers are privately funded. He explained the Thaw device is a natural fit with CellSeal vials, but the evo platform has different decision-makers, limiting bundling opportunities.

The analyst, calling on behalf of Raghuram Selvaraju, asked about the consumer pricing for NIAGEN+, how its sales are categorized in financial reporting, and the potential for future gross margin improvements.

Answer

The company stated that clinics typically charge between $500 and $700 for a NIAGEN IV session. These sales are reported under the 'ingredient' business segment as 'pharmaceutical grade'. While NIAGEN+ has higher margins, the overall company gross margin is expected to remain in the current range due to the mix of business, with some segments exerting downward pressure.