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Ocugen (NASDAQ: OCGN)
Q4 2023 Earnings Call
Apr 02, 2024, 8:30 a.m. ET

What Story Do the Numbers Tell?

• Prepared Remarks
• Questions and Answers
• Call Participants

A Warm Welcome Amidst Business Updates

Operator

Good morning and welcome to Ocugen’s business update delving into the financial highlights of the year that was 2023. Please note the ongoing recording. All lines are in listen-only mode as we delve into insights from the executives followed by a Q&A session post their addresses.

Now, I pass the baton to Tiffany Hamilton, the voice of Ocugen’s communications, to kickstart the dialogue.

Tiffany Hamilton — Head of Corporate Communications

Thanks to our operator. Today in the spotlight is Dr. Shankar Musunuri, Orogen’s chairperson, CEO, and co-founder, set to take us through Ocugen’s recent business ups and downs. Also onboard is Michael Breininger, corporate controller, to shed light on the financial aspect of 2023.

Answering burning questions during the Q&A session is Dr. Huma Qamar, chief medical officer. A press release issued today outlines the operational feats of Ocugen in 2023. Audiences can access more details on ocugen.com.

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Now, as conversations unfold, remember, there’s a replay recording lined up on Ocugen’s investor portal for the forthcoming 45 days. But remember, there’s a disclaimer on forward-looking statements as the presentation continues.

Shankar Musunuri — Co-Founder, Chairman, and Chief Executive Officer

Expressing gratitude, good morning to all our attendees. Reflecting on the strides of last year, the undivided effort of our team paves the path for a groundbreaking 2024, especially pertaining to our gene therapy programs targeting blindness ailments. Our successes go beyond science – they touch the core of human lives.

Permit me to recount a moving tale that solidifies our motto ‘courageous innovation’. In our OCU400 trial for retinitis pigmentosa, affecting around 100,000 in the U.S. and 1.6 million worldwide, a 60-year-old patient narrated his journey. RP crippled his vision, threatening autonomy and vitality. The trial metamorphosed his life – a year post OCU400 treatment, his dosed eye shows signs of vision revival.

Getting to know individuals like him fuels our pursuit of ground-breaking solutions to treat neglected diseases. In our 2023 review, we bask in the accolades from FDA and other regulatory bodies across various fronts.

Our strides in vaccine and cell therapy domains stand out. Bagging non-dilutive funding and locking horns with NIAID in Project NextGen showcases our commitment to fighting COVID-19 while minimizing financial burden on our shareholders. Further, NeoCart, our 3D regenerative cell therapy, gears up post flawless cGMP facility revamp.

Grabbing this legacy torch, we’re evaluating avenues to steer NeoCart’s journey, aligning with market trends and regulatory shifts. Before the gene therapy rundown, let’s ponder the evolving gene therapy market dynamics and Ocugen’s role within it.

Ocugen’s Impressive Journey in the Gene Therapy Realm

Gene Therapy Market Growth

A surge of interest in genetic and cell therapies has been witnessed, catalyzed by technological advancements, escalated investments, increased clinical activity, and accommodating regulatory frameworks. The latest M&A transactions reflected the allure and necessity of gene therapies. Industry forecasts hint at the global gene therapy market exceeding $30 billion by the end of the decade.

Positive Results for OCU400 in Phase 3 Study

Aligning with the FDA on critical design aspects of the OCU400 phase 3 study signifies a significant milestone. As the sole gene therapy in a phase 3 trial endowed with a broad RP designation, Ocugen stands at a pioneering forefront. The FDA’s green light for OCU400’s phase 3 trial design underscores its robust safety and efficacy, as evidenced by promising outcomes in the preceding phase 1/2 trial.

Strides Toward Phase 3 Trial for RP Patients

The measurement tools – MLMT, LLVA, BCBA – utilized in the assessment of OCU400’s efficacy showcased notable advancements or preservation in treated eyes across all categories. The inclusion of LDNA as the primary endpoint for RP patients in the upcoming phase 3 study highlights a novel approach directed towards functional vision changes in patients grappling with inherited retinal diseases.

Advancements in OCU410 and OCU410ST for GA and Stargardt Disease

With the completion of dosing for Cohort 1 in the OCU410 ArMaDA and OCU410ST GARDian phase 1/2 clinical trials in Q1 of 2024, Ocugen marks its progress in addressing geographical atrophy and Stargardt Disease – maladies with scarce treatment options. OCU410’s holistic regulation of multiple disease pathways and potential for a single lifelong treatment offers a promising avenue for the 1 million GA patients in the U.S. and 40,000 individuals affected by Stargardt Disease.

Financial Resilience and Future Prospects

Despite the restatement of financial statements for the year ending December 31, 2022, Ocugen maintains a secure financial standing. The restated periods, although indicating errors in noncash accounting, are projected to have no bearing on cash reserves or financial outlook. With cash, cash equivalents, and investments amounting to 39.5 million as of December 31, 2023, Ocugen foresees sufficient funds to sustain operations well into the fourth quarter of 2024.

Focus on Patient Well-being and Therapeutic Efficacy

Ocugen’s commitment resonates beyond financial figures, encapsulating a deep-seated dedication to enhancing patient outcomes and quality of life. The team’s collaborative ethos, underscored by the strategic appointment of Dr. Huma Qamar as the Chief Medical Officer, reflects a strategic vision aimed at driving therapeutic innovation and fostering clinical excellence.

Embracing the Path to Market Approval

Guided by a patient-centric approach and a relentless pursuit of groundbreaking therapies, Ocugen’s trajectory signifies a pivotal moment in the evolution of gene therapy. The intrinsic value of OCU400’s clinical data, compounded with the strategic leadership appointments, positions Ocugen as a frontrunner in the evolutionary landscape of genetic and cell therapies.

An Exciting Juncture Ahead for A Promising Gene Therapy Company

Positive Momentum Amidst Regulatory Milestones

Entering the new year on a high note, the gene therapy company has just received critical FDA approval for its clinical protocols, setting the stage for the initiation of groundbreaking studies this month. Such alignment is no small feat, reminiscent of past triumphs in the biotech sector where regulatory blessings often heralded significant advancements. This is akin to a skilled conductor orchestrating a symphony of progress in the realm of medical innovation.

Progress Update on Clinical Studies

During an engaging dialogue with analysts, valuable insights were shared regarding the company’s advancements in various studies. The Chief Medical Officer shed light on the meticulous approach toward dose escalation in the 410ST study, emphasizing a steady path forward. The forthcoming release of safety data from initial cohorts promises transparency and guidance akin to a compass directing a ship through uncharted waters.

Additionally, discussions on the NeoCart program unveiled a well-prepared infrastructure poised for phase 3 endeavors. The company’s readiness echoes the meticulous preparation akin to a chef gathering ingredients before embarking on crafting a culinary masterpiece. However, the importance of securing adequate funding as emphasized by the CEO reminds us of the financial undercurrents shaping the research landscape.

Strategic Insights into Gene Therapy Trials

As conversations delved deeper into the specifics of the OCU400 trial, the significance of a mutation-agnostic approach emerged. The Chief Medical Officer’s clarity on patient inclusion criteria painted a picture of inclusivity and innovation in addressing unmet medical needs. Such bold strategies mirror historical breakthroughs where audacious leaps paved the way for transformative treatments.

Looking Ahead with Optimism

As the call drew to a close, the Co-Founder and CEO articulated a vision brimming with promise and purpose. With milestones on the horizon and a strategic roadmap leading towards approval targets, the company stands at a juncture laden with opportunity. The dynamic growth in the gene therapy market alludes to a landscape ripe for exploration akin to a vast frontier waiting to be charted.

Amidst all the clinical progress and potential, the mention of pursuing partnership opportunities encapsulates a collaborative spirit essential for collective advancement. The spirit of innovation driving the company forward echoes an age-old adage – “necessity is the mother of invention,” guiding us towards breakthroughs in modern medical science.

As stakeholders continue to champion the cause, the commitment towards making a positive impact on patients’ lives globally resonates deeply. With a backdrop of clear objectives and resounding support, the company’s journey appears to be one where every step is laden with purpose and unwavering dedication.

In conclusion, as the industry forges ahead into uncharted territories of gene and cell therapies, the gene therapy company stands as a beacon of hope and progress. The unfolding narrative of innovation and compassion intertwines to create a compelling story of humanity’s unyielding pursuit of healing and transformation.