Introduction: Q3 earnings, maintaining a buy rating
Immunovant (NASDAQ:IMVT), a biopharmaceutical company focusing on autoimmune diseases, continues to show promising developments in its clinical trials and financial stability. Their efforts are primarily centered around batoclimab (IMVT-1401) and IMVT-1402, both FcRn inhibitors. The positive trajectory in their clinical trials, coupled with robust financial backing, warrants maintaining a buy rating for Immunovant.
Immunovant’s continuous progression in clinical trials, coupled with its strong financial position, underpins the rationale for maintaining a buy rating. The potential market penetration of IMVT-1402 and batoclimab across various autoimmune diseases, alongside their competitive profiles against existing therapies, presents a significant upside, analogous to the anti-TNF class that expanded into multiple indications and became a multibillion-dollar franchise. While there are risks, including competition and regulatory hurdles, the company’s strategic focus and robust pipeline offer promising prospects.
Key Q3 update: Clinical Developments
IMVT-1402’s Progress: The Phase 1 trials with IMVT-1402 have shown encouraging results, especially with the single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The drug’s subcutaneous route of administration positions it uniquely against competitors like argenx’s (ARGX) efgartigimod and UCB’s rozanolixizumab. Furthermore, IMVT-1402’s deep IgG reductions and favorable safety profile enhance its potential in the market.
Batoclimab’s Potential is not priced into the company’s valuation: Batoclimab, another key product in Immunovant’s portfolio, is expected to yield initial proof-of-concept Phase 2 data in Graves’ disease by late 2023. This development could accelerate IMVT-1402’s advancement in treating Graves’ disease. Additionally, Phase 2b results in chronic inflammatory demyelinating polyneuropathy (CIDP) and Phase 3 trial data for myasthenia gravis (MG) and thyroid eye disease (TED) are on the horizon.
Multiple Catalysts on Sight
The upcoming catalysts for Immunovant are pivotal events that could significantly impact the company’s valuation and future trajectory. These include:
IMVT-1402 Phase 1 Data: The initial data from the 600 mg multiple ascending dose cohort of the Phase 1 healthy volunteer study for IMVT-1402 are anticipated in November 2023. This data is crucial as it could validate the efficacy and safety of IMVT-1402, especially regarding IgG reduction and the absence of adverse impacts on albumin and LDL.
Batoclimab Phase 2 Data in Graves’ Disease: By the end of 2023, Immunovant is expected to release initial results from its Phase 2 study of batoclimab in treating Graves’ disease. Positive results here could advance batoclimab over IMVT-1402 for this indication and potentially position Immunovant as a first-mover in this space.
Batoclimab Phase 2b Results in CIDP: In the first half of 2024, initial results from the Phase 2b study of batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) are anticipated. The outcome of this study could be a significant driver for the company, especially in light of the comparative data from argenx’s ADHERE trial.
Phase 3 Data for Batoclimab in Myasthenia Gravis: Topline results from the pivotal Phase 3 trial with batoclimab for myasthenia gravis (MG) are expected in the second half of 2024. Given that FcRn inhibition is a well-validated mechanism in MG, these results are highly anticipated.
Phase 3 Data for Batoclimab in Thyroid Eye Disease: In the first half of 2025, topline results from the two Phase 3 studies in thyroid eye disease (TED) with batoclimab are expected. Positive outcomes could significantly boost the drug’s profile and market potential.
Each of these catalysts carries the potential to either significantly boost Immunovant’s standing in the biopharmaceutical market, especially in the autoimmune segment, or present challenges depending on the outcomes. Positive results could enhance investor confidence and pave the way for future growth, while any setbacks could necessitate a reassessment of the company’s strategies and prospects.
Immunovant’s financial standing remains robust, with a cash balance of $737 million after a recent fundraising. Considering that Q3 cash burn is ~$60M, if we assume this rate of cash burn continues moving forward, we see around two years + of cash runway. We believe this financial stability is crucial for sustaining their extensive research and development activities, even if the tough capital market condition continues. The company’s R&D expenses reflect its commitment to advancing its clinical programs.
Simply put, Immunovant is trading around $4Bn while argenx is trading at ~$26.7Bn, when two companies are developing a similar anti-FcRn platform. We see IMVT as a call-option for investors in order to have some exposure in the growing anti-FcRn space. We expect the platform to be highly versatile in multiple autoimmune indications and for the platform value of Immunovant to continue to expand, similar to what we have seen with anti-TNFs.
Market Potential and Competition
Competitive Landscape: The FcRn inhibitor market is becoming increasingly competitive. Johnson & Johnson and argenx are key players, with J&J reporting Phase 2 data for nipocalimab in rheumatoid arthritis and argenx advancing Vyvgart Hytrulo. Immunovant’s IMVT-1402 and batoclimab need to demonstrate distinct advantages in efficacy and administration to capture market share.
Indication Expansion and Revenue Potential: Immunovant’s strategic focus on niche markets like Graves’ disease and broader indications such as MG and CIDP positions them to potentially capture significant market shares. Based on current data, IMVT-1402 and batoclimab could generate substantial revenues, with IMVT-1402 potentially entering the market for Graves’ disease by late 2027/early 2028.
Clinical Trial Outcomes: The success of Immunovant hinges on the positive results of clinical trials for IMVT-1402 and batoclimab. Any negative outcomes or safety concerns could significantly impact the company’s valuation and future prospects.
Regulatory Approvals: Navigating the regulatory landscape is crucial for Immunovant. Delays, stringent requirements, or failure to obtain necessary approvals from bodies like the FDA could derail their drug commercialization plans.
Market Competition: The competitive landscape in the FcRn inhibitor market is intensifying. Major players like Johnson & Johnson and argenx with similar or more advanced products could limit Immunovant’s market share and growth potential.
Commercialization Challenges: Successfully bringing a drug to market involves overcoming hurdles in pricing, reimbursement, market acceptance, and effective sales and marketing strategies. Failure in any of these areas could limit the commercial success of Immunovant’s products.
Financial Sustainability: Despite a robust current financial position, the long-term financial health of Immunovant is contingent on its ability to manage R&D expenses effectively and eventually generate substantial revenue from its drug candidates.
We have evaluated the recent Q3 2023 earnings update and recent clinical data, and we maintain a buy rating on Immunovant moving into 2024. Immunovant’s current trajectory in clinical development, combined with its financial robustness and strategic market positioning, supports the continuation of a buy rating. The upcoming data releases will be pivotal in determining the long-term success of their key drug candidates. Given the potential market size (argenx’s robust ramp of ~$320M product sales in Q3 2023 is a great benchmark) and the efficacy of their drug candidates, Immunovant presents a compelling and de-risked investment opportunity in the biopharmaceutical sector moving forward.