Louise Chen

Louise Chen inquired about Amgen's outlook on Tepezza, considering a potential new competitor, and the current status of AMG 732 for Thyroid Eye Disease (TED).

Answer

James Bradner, EVP of Research and Development, highlighted Tepezza's strong evidence base and ongoing subcutaneous Phase 3 study, with completion expected in the second half of 2026. He also noted AMG 732, an IGF-1R targeting monoclonal antibody, is in Phase 2 enrollment. Murdo Gordon, EVP of Global Commercial Operations, discussed Tepezza's expanding market penetration, including endocrinologist prescribing and successful international launches.

Louise Chen from Scotiabank asked about Amgen's perspective on potential new competitors for Tepezza and provided an update on the development status of AMG 732 for Thyroid Eye Disease (TED).

Answer

James Bradner, EVP of Research and Development, highlighted Tepezza's strong evidence base across patient populations and confirmed the subcutaneous Phase III study is fully enrolled, with completion expected in the second half of the year. He also mentioned AMG 732, an IGF-1R targeting monoclonal antibody, is in Phase II for moderate to severe active TED. Murdo Gordon, EVP of Global Commercial Operations, added that Tepezza is expanding treatment to lower clinical activity score patients, increasing endocrinologist prescribing, and seeing strong international launches, positioning it as a key growth driver.

Louise Chen from The Bank of Nova Scotia asked about the integration of Seagen since its acquisition and how it enhances Pfizer's oncology leadership. She also inquired about the differentiation strategy for Pfizer's PD-1/VEGF bispecific in an increasingly crowded market, especially given other indications coming before theirs.

Answer

Dr. Chris Boshoff, Chief Scientific Officer, Pfizer, stated that Seagen's integration has gone very well across research, commercial, and manufacturing, with most colleagues remaining at Pfizer. He highlighted accelerated programs like PADCEV (with planned Phase 3 studies to potentially replace cystectomy) and SV (with two ongoing Phase 3 studies). For 4404 (PD-1/VEGF bispecific), he noted its differentiation through 100-fold increased affinity for PD-1 in the presence of VEGF and binding to all VEGF-A isoforms, with encouraging preclinical data and positive first-line NSCLC data from China. He mentioned accelerated Phase 3 programs for colorectal, NSCLC, endometrial, and bladder cancers, including combinations with ADCs.

Louise Chen asked about the integration of the Seagen acquisition, how it has progressed, and how it enhances Pfizer's leadership in oncology. She also inquired about Pfizer's strategy to differentiate its PD-1/VEGF bispecific (4404) in an increasingly crowded market.

Answer

CEO Albert Bourla highlighted the successful integration of Seagen across research, commercial, and manufacturing. Chief Scientific Officer Chris Boshoff noted high colleague retention, acceleration of programs like PADCEV (with an additional phase III study planned to potentially replace cystectomy), and other ADCs. For 4404, he cited differentiated preclinical data showing 100-fold increased affinity for PD-1 in the presence of VEGF and binding to all VEGF-A isoforms. He mentioned encouraging data with chemotherapy and accelerated phase III programs for colorectal, non-small cell lung, endometrial, and bladder cancers, including combinations with Pfizer's ADC portfolio.

Louise Chen asked about the major factors influencing 2025 sales and EPS and the timing of guidance. She also requested an update on the Seagen integration and its long-term financial metrics.

Answer

CFO David Denton indicated that 2025 guidance, which will detail various financial 'pushes and pulls,' will likely be provided by the end of the current year. EVP and Chief Oncology Officer Chris Boshoff reported that the Seagen integration is progressing very well, with high employee retention and strong revenue of $2.3 billion year-to-date. He highlighted pipeline advancements but did not provide an update to the 2030 sales forecast.

Louise Chen asked about the perceived disconnect between Teva's pipeline excitement and market valuation, and how to model AUSTEDO's performance in 2027, considering IRA and other factors.

Answer

CEO Richard Francis suggested the pipeline's rapid progress might have surprised investors, emphasizing the quality of assets like anti-TL1A and Duvakitug. Head of R&D and CMO Eric Hughes added that external validation (Royalty Pharma, Sanofi, Abingworth) across programs underscores their value. Richard Francis declined to give 2027 AUSTEDO guidance but reiterated the $2.5 billion target, noting the large untreated patient population for Tardive dyskinesia and the benefits of AUSTEDO XR.

Louise Chen of Scotiabank asked about the perceived disconnect between Teva's excitement for its pipeline and the Street's current valuation, and how to model AUSTEDO's performance in 2027 given the impact of IRA and other market dynamics.

Answer

CEO Richard Francis and Head of R&D Eric Hughes attributed the pipeline's underappreciation to its rapid advancement and quality, citing external validation for multiple programs. Richard Francis declined specific 2027 AUSTEDO guidance but reaffirmed the $2.5 billion target, emphasizing the large untreated patient population and the benefits of AUSTEDO XR adoption.

Louise Chen of Scotiabank inquired about any updates on a potential European Union partner for Ardelyx's products and asked about the company's timeline for achieving cash flow positivity.

Answer

President and CEO Mike Raab addressed the questions, stating that reaching cash flow breakeven is a clear and important goal that is "not that far off on horizon" based on current guidance. Regarding a potential EU partner, he noted that while the company continues to evaluate opportunities, there was nothing substantive to report at this time.

Louise Chen of Cantor Fitzgerald inquired about the expected improvement of the IBS-C market after its typical Q1 contraction and asked for a detailed explanation of the XPHOZAH returns reserve release.

Answer

CFO and COO Justin Renz explained the XPHOZAH returns reserve was a one-time, $3.8 million non-cash adjustment due to zero product returns since launch, and it will not be carried forward. CCO Eric Foster confirmed that the IBS-C market is expected to improve, noting that despite the traditional Q1 contraction, IBSRELA maintained prescription demand consistent with Q4 and exited the quarter with strong momentum.

Louise Chen asked about the percentage of XPHOZAH sales outside the Medicare bundle, the company's strategy for portfolio expansion, and the anticipated timeline for IBSRELA to achieve its $1 billion peak sales target.

Answer

President and CEO, Mike Raab, stated that the payer mix for XPHOZAH is generally 60% Medicare and 40% non-Medicare. He confirmed that portfolio expansion efforts are ongoing but noted it is too early to provide a specific timeline for IBSRELA's peak sales achievement, pending performance data from the newly expanded sales force.

Louise Chen of Scotiabank inquired about the specific market share targets ALK-Abello must achieve to trigger performance-based payments and asked for neffy's current market share.

Answer

Chief Commercial Officer Eric Karas reported neffy's overall market share is 1.3%, but it is 6.2% among their target physicians. He noted that the ALK co-promotion expands their reach to 20,000 physicians and expressed confidence in hitting the milestone targets, which he described as reasonable, given upcoming catalysts.

Louise Chen of Scotiabank posed several questions regarding the duration of prior authorizations, data on neffy adoption among previously untreated patients, and the potential impact of epinephrine moving over-the-counter (OTC).

Answer

Richard Lowenthal, CEO, and Eric Karas, CCO, responded that prior authorization requirements vary by payer but represent a significant hurdle, reinforcing their strategy to secure unrestricted access. While specific data on untreated patients is pending a claims analysis, they see a major opportunity to re-engage this group. Regarding an OTC switch, Lowenthal deemed it unlikely in the near term due to significant FDA hurdles related to safety and the difficulty of self-diagnosis for anaphylaxis.

Louise Chen inquired if management is comfortable with current consensus estimates for VYVGART and full-year revenue, and asked if there was any delay or concern regarding the timing of the bemarituzumab FORTITUDE-101 study data.

Answer

Joshua Smiley, President and COO, reaffirmed the full-year revenue guidance of $560M-$590M and stated that VYVGART's expected growth rate is in line with consensus. Dr. Rafael Amado, President and Head of Global R&D, confirmed the bemarituzumab data is still expected in Q2 2025 and advised against reading into the specific timing of the release.

Louise Chen of Cantor Fitzgerald asked for an update on the regulatory status and commercial opportunity for KarXT in China, and also questioned the expected sales trajectory for VYVGART throughout 2024.

Answer

Dr. Harald Reinhart, President and Head of Global Development, detailed that the KarXT bridging study is nearing completion, which will support an NDA filing in early 2025. President and COO Josh Smiley added that the commercial opportunity is significant. Regarding VYVGART, Smiley confirmed they are on track to exceed $70 million in 2024 sales and expect steady, sequential quarterly growth.

Louise Chen asked what percentage of the new 2025 guidance is represented by ELEVIDYS and whether the company expects sales to recover starting in the third quarter.

Answer

President and CEO Douglas Ingram confirmed the guidance reduction was exclusively from ELEVIDYS and that the company anticipates a significant sales uptick starting in the summer and continuing through the second half of the year. Executive Ian Estepan specified that the PMO franchise guidance remains unchanged at around $900 million, meaning the entire revision applies to ELEVIDYS.

Louise Chen of Cantor Fitzgerald inquired about the expected timeline for an interim data readout from the VERSATILE-003 trial and the company's current perspective on the trial's market opportunity, considering recent changes in the competitive landscape like Merck's KEYNOTE-689 trial.

Answer

Executive Frank Bedu-Addo stated that after thorough analysis and consultation with key opinion leaders, the company believes the KEYNOTE-689 trial will not significantly impact its target population of checkpoint inhibitor-naive, recurrent/metastatic HPV16-positive head and neck cancer patients. He highlighted that this patient segment is growing rapidly. Regarding timing, he estimated an 18-month enrollment period followed by an interim data readout approximately six months after completion. Executive Kirk Shepard added that strong interest from sites involved in the previous VERSATILE-002 study reinforces their confidence in the enrollment timeline.

Louise Chen asked for guidance on modeling MIPLYFFA sales for Q4 2024, the next steps and timing for European expansion, and the potential timing and value of the recently received Priority Review Voucher (PRV).

Answer

President and CEO Neil McFarlane stated that the 30% of enrollments already approved for reimbursement will receive product in Q4 as soon as it's available, with more approvals expected. He noted that EU expansion is a top priority, but timing is pending discussions with the EMEA, with an update expected in early 2025. Regarding the PRV, McFarlane highlighted recent market transactions near $150 million and stated they are actively monitoring the market to monetize it. CFO LaDuane Clifton added that the recent financing provides flexibility to time the PRV sale optimally.

Louise Chen of Cantor Fitzgerald inquired about the efficacy targets for the Phase III trial of brepocitinib in non-infectious uveitis (NIU) and asked for an update on the development status of brepocitinib for hidradenitis suppurativa (HS).

Answer

CEO Matt Gline and Priovant CEO Ben Zimmer explained that efficacy approximating the strong Phase II results would be a terrific outcome, providing a wide margin over competitors like HUMIRA. Regarding HS, they noted it's a competitive field and while it remains on the radar, they are also evaluating other, potentially less competitive, indications for brepocitinib.

Louise Chen of Cantor Fitzgerald asked if Immunovant's FcRn inhibitor for RA would always be targeted at the refractory patient population or if it could have opportunities in earlier lines of therapy.

Answer

Executive Peter Salzmann stated that due to practical, healthcare system economics, the focus will remain on the difficult-to-treat subpopulation. He explained that with many anti-cytokine therapies available as much cheaper generics or biosimilars, payers will likely require patients to fail those first. This makes the refractory setting the most logical and commercially viable target for an advanced therapy like an FcRn inhibitor.

Louise Chen asked whether an FcRn inhibitor for rheumatoid arthritis would always be positioned for the refractory patient population or if it has the potential to move into earlier lines of therapy.

Answer

Executive Peter Salzmann explained that from a practical standpoint, the therapy is aimed at the difficult-to-treat population. He reasoned that healthcare systems would require patients to first try much less expensive generic and biosimilar therapies, making the refractory setting the most logical and commercially viable position for an advanced therapy like an FcRn inhibitor.

Louise Chen of Cantor Fitzgerald requested an overview of the major puts and takes for Merck's 2025 outlook and asked when the company plans to provide formal guidance.

Answer

CFO Caroline Litchfield stated that formal 2025 guidance will be issued with the Q4 earnings report. She anticipates 'solid growth' driven by KEYTRUDA in earlier-stage cancers, WINREVAIR, CAPVAXIVE, and the upcoming clesrovimab launch. Key headwinds include the expiration of the immunology agreement with Johnson & Johnson and the expected decline in GARDASIL sales in China. Despite these factors, she expects operating margin expansion in 2025.

Louise Chen of Cantor Fitzgerald questioned how Johnson & Johnson's immunology pipeline, including TREMFYA and JNJ-2113, is positioned to replace sales lost from STELARA's LOE and gain market share from competitors.

Answer

Jennifer Taubert, Executive VP of Innovative Medicine, stated that TREMFYA is seen as a 'STELARA size or bigger and better' asset, especially with its new ulcerative colitis approval and strong data. John Reed, also an Executive VP of Innovative Medicine, detailed the progress of JNJ-2113, an oral peptide for psoriasis and ulcerative colitis, highlighting its fully enrolled Phase III psoriasis studies and upcoming data readouts.

Inquired about the market opportunity for SPR720 in light of recent competitor news, its potential positioning in the treatment paradigm, and the future development plans and market for SPR206.

Answer

The company's view on the SPR720 market opportunity is unchanged as they are targeting the first-line market, which is different and larger than the competitor's refractory market. They aim for SPR720 to be a first-line therapy for the majority of patients. For SPR206, further development is contingent on securing non-dilutive funding from partners or government agencies.

Louise Chen of Cantor Fitzgerald inquired about the potential pricing for Remestemcel's pediatric opportunity, the company's cash runway, and whether the first half's operating expenses are a reliable proxy for the remainder of the year.

Answer

Silviu Itescu (executive) explained that pricing for the pediatric GVHD product would likely fall between CAR-T products and curative gene therapies, reflecting its durable survival benefits. He confirmed a 25% reduction in quarterly burn, stating the company has at least 12 months of cash runway to fund planned trials. He also noted that ongoing discussions for strategic partnerships could substantially extend this runway.

Louise Chen inquired about the potential pricing for Remestemcel in its pediatric indication, the company's current cash runway, and whether first-half operating expenses are a reliable proxy for the remainder of the year.

Answer

Executive Silviu Itescu explained that while specific pricing for Remestemcel is undisclosed, it is expected to be positioned between CAR-T products and curative gene therapies, reflecting its long-term survival benefits. He confirmed a cash runway of at least 12 months, supported by a 25% quarterly burn rate reduction, which is sufficient to fund planned trials. Itescu also noted that ongoing strategic partnership discussions could significantly extend this runway.

Louise Chen of Cantor Fitzgerald inquired about the potential pricing for Remestemcel's pediatric opportunity, the company's cash runway, and whether the first half's operating expenses are a good proxy for the rest of the year.

Answer

Executive Silviu Itescu explained that pricing for Remestemcel would likely fall between CAR-T products and curative gene therapies, reflecting its durable survival outcomes. He confirmed a 25% reduction in quarterly burn, providing at least 12 months of cash runway sufficient to fund planned trials, with potential extension through strategic partnerships. He also indicated the current burn rate would be maintained or further reduced, serving as a forward-looking proxy.

Louise Chen of Cantor Fitzgerald inquired about the potential pricing for Remestemcel's pediatric opportunity, the company's current cash runway, and whether the first half's operating expenses serve as a reliable proxy for the remainder of the year.

Answer

Executive Silviu Itescu explained that while specific pricing for Remestemcel is not public, it would likely fall between CAR-T products and curative gene therapies, reflecting its durable survival benefits. He confirmed a cash runway of at least 12 months, supported by a 25% reduction in quarterly cash burn, which already accounts for planned pivotal trials. Itescu also noted that strategic partnership discussions are underway, which could significantly extend this runway.

Asked about plans for a public update following the FDA Type A meeting, the shelf-life of the existing remestemcel inventory, and the anticipated cost and timing for the new adult GVHD study.

Answer

A detailed update will be provided to the market post-meeting. The product inventory has a shelf-life of at least four years which can be extended with ongoing testing. The adult study is projected to be a small, targeted, and inexpensive trial due to collaboration with the CTN network, and its costs will be covered by the announced spending reductions.

Asked about the competitive advantage provided by their global manufacturing capacity, the strategy for advancing their PCV candidates in the infant population, and what the VAX-31 adult data might imply for the infant program.

Answer

The company stated that large-scale manufacturing capacity is 'table stakes' for securing a broad recommendation from bodies like ACIP. Their new dedicated facility is designed to meet global demand for both adult and infant indications. For the infant market, the strategy is more nuanced than for adults; because VAX-24 is significantly ahead developmentally, they plan to advance it to market first, while also considering VAX-31 for the future, making it a potential 'either or both' scenario.

Louise Chen asked CEO Raj Kannan to elaborate on his vision and timeline for I-Mab, inquired about the ex-China opportunity for lemzoparlimab with AbbVie, and asked about other key data presentations expected in 2023.

Answer

CEO Raj Kannan outlined a 24-month timeline, aiming for significant progress by the end of 2025. He confirmed AbbVie had terminated the global development of lemzoparlimab, and I-Mab has no current plans for it outside of China. CMO John Hayslip added that no other major data presentations are scheduled for the remainder of 2023 beyond the givastomig data at ESMO.

Louise Chen of Cantor Fitzgerald raised concerns about the historical toxicity issues of 4-1BB agonists that have prevented high target engagement in other programs and asked if more results from the givastomig dose escalation study could be expected.

Answer

Andrew Zhu, Acting CEO, addressed the toxicity concerns by emphasizing givastomig's unique bispecific design, which induces 4-1BB activation only upon engagement with Claudin18.2 at the tumor site. He explained this mechanism spares the systemic toxicities, such as hepatic toxicity and cytokine release syndrome, commonly seen with other 4-1BB agonists. This favorable safety profile, including mild GI toxicity, has been demonstrated in the ongoing Phase 1 trial.

Louise Chen asked about I-Mab's strategy to address the regulatory risks associated with the Holding Foreign Companies Accountable Act (HFCAA) and requested an update on the company's current progress with its dual listing in Hong Kong.

Answer

Jingwu Zang, Founder, Chairman and Acting CEO, stated the company is optimistic and is taking two main actions: switching to a PCAOB-recognized auditor and accelerating the Hong Kong dual listing process. John Long, CFO, elaborated that the company has engaged professional firms to assess the auditor change, aiming to complete the process by the end of 2022. He also mentioned they are accelerating the dual primary listing project and are hopeful for improved market conditions in the second half of the year to complete it.

Louise Chen of Cantor Fitzgerald inquired about the potential timing and valuation of an out-licensing deal for BREXAFEMME, the company's strategy for succeeding in the competitive hospital setting, and guidance for Q4 sales and future operating expenses following the corporate restructuring.

Answer

President & CEO Dr. Marco Taglietti stated that active conversations with potential partners for BREXAFEMME are ongoing and that the expected PDUFA approval for recurrent VVC would enhance the asset's value. Dr. David Angulo, Chief Medical Officer, added that ibrexafungerp is well-differentiated to address significant unmet needs in the hospital setting, a space with few treatment options. Regarding financials, Dr. Taglietti noted a conservative outlook for Q4 sales due to halting active promotion, though this may be offset by new PBM coverage. He suggested that future operating expenses would be similar to pre-commercial levels of 2019-2020.

Louise Chen from Cantor Fitzgerald inquired about CBP-201's differentiation in the crowded atopic dermatitis market, the potential timing for a CBP-307 partnership, and the market opportunity for CBP-201 in asthma.

Answer

Co-Founder and CEO Dr. Zheng Wei explained that CBP-201 aims to differentiate through superior efficacy and a more convenient Q4W dosing schedule. He confirmed ongoing partnership discussions for CBP-307 but offered no specific timeline. Chief Medical Officer Dr. Chin Lee added that CBP-201 has the potential to be a competitive molecule in both atopic dermatitis and asthma, with asthma data expected in the first half of 2023.

Louise Chen of Cantor Fitzgerald inquired about the new management team's strategic differences, the sales outlook for ANNOVERA in Q1 2022 given Q4 2021 demand, and the specifics of the debt refinancing plan using proceeds from the vitaCare divestiture.

Answer

CEO Hugh O’Dowd responded that the new management team is forward-looking, focused on four key priorities, and committed to accountability without overpromising. CFO James D’Arecca added that unfilled ANNOVERA demand in Q4 was at least 6,000 units and confirmed that proceeds from the vitaCare sale will be used to pay down the Sixth Street debt, with more detailed cash flow guidance to follow post-transaction.

Louise Chen of Cantor Fitzgerald inquired about the timing of the CEO change, the new strategic vision under Hugh O'Dowd, the expected progression of SG&A expenses, and the status of the VitaCare divestiture.

Answer

CEO Rob Finizio explained the CEO transition was a planned succession over a year in the making and that he remains committed as Vice Chairman. President Hugh O'Dowd outlined his immediate priorities: driving top-line growth, executing a $60 million cost-savings initiative (including the VitaCare divestiture) to achieve EBITDA breakeven in H2 2022, and addressing the capital structure. CFO James D'Arecca confirmed that SG&A is expected to be below $50 million in Q4 2021 and that the company plans to divest VitaCare, which accounts for $20 million of the total cost savings.