Ocugen (OCGN) to Report Q1 Earnings: What’s in the Cards? – April 26, 2024


Ocugen, Inc. (OCGN Free Report) is likely to provide updates on its pipeline developments when it reports first-quarter 2024 results.

Let’s see how things have shaped up for the quarter to be reported.

Factors to Consider

With no marketed drugs in its portfolio, Ocugen is unlikely to have recorded any revenues during the first quarter. However, the company has several clinical-stage, novel gene therapy candidates in its pipeline, which are being developed for various ophthalmologic indications.

The focus, consequently, is on pipeline progress.

The company is currently developing OCU400, its gene-agnostic modifier gene therapy candidate based on the NR2E3 gene, in separate studies for two rare retinal diseases, namely retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA).

Earlier this month, Ocugen announced that the FDA has cleared its investigational new drug amendment to initiate a pivotal phase III liMeliGhT study on OCU400 for the treatment of RP.

Shortly after, the Committee for Medicinal Products for Human Use of the European Medicines Agency opined that the results of the pivotal liMeliGhT study of OCU400 being conducted in the United States could be accepted as a basis for a regulatory filing in the EU for the RP indication, following a thorough review of the same. The encouraging safety and tolerability data from the phase I/II study of the candidate for RP formed the basis of the advisory committee’s opinion.

Dosing of patients with OCU400 in the phase III RP study is expected to begin in the second quarter of 2024.

A separate early to mid-stage study is also currently ongoing and evaluating OCU400 in LCA patients. Subject to positive results from the phase I/II LCA study and upon reaching alignment with the FDA, Ocugen expects to expand OCU400 phase III development in LCA patients in the second half of 2024.

Further updates from the OCU400 development program for RP and LCA are expected in the first-quarter earnings release.

Apart from OCU400, the company has two other gene therapy candidates, OCU410 and OCU410ST, utilizing the nuclear receptor gene RORA, which is being developed in separate early to mid-stage studies as a one-time treatment for dry age-related macular degeneration and Stargardt, respectively.

Ocugen is also currently gearing up to initiate a phase III confirmatory study of its regenerative medicine cell therapy technology, NeoCart, in the second half of 2024, to treat articular cartilage defects in the knee. NeoCart is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing the patient’s own chondrocytes, the cells responsible for maintaining cartilage health.

The initiation of the late-stage study is, however, contingent upon the availability of adequate funds.

The company’s operating expenses (comprising research and development and general and administrative expenses) are expected to lower in fiscal year 2024 due to a reduced headcount as well as internal cost-saving initiatives.

Ocugen is facing a serious cash crunch at present. As of Dec 31, 2023, the company had cash, cash equivalents, and investments totaling $39.5 millioncompared with $90.9 million as of 2022-end, which is projected to barely fund its operations into the fourth quarter of 2024.

Earnings Surprise History

The company beat estimates in three of the trailing four reported quarters and missed on the other occasion.

Year to date, shares of OCGN have surged 105.2% against the industry’s 9.4% decline.

Earnings Whisper

Our proven model does not conclusively predict an earnings beat for Ocugen this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. Unfortunately, that is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.

Earnings ESP: Ocugen has an Earnings ESP of 0.00% as the Most Accurate Estimate and the Zacks Consensus Estimate are both pegged at a loss of 6 cents.

Zacks Rank: Ocugen currently carries a Zacks Rank #3.

Stocks to Consider

Here are some stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle.

Sarepta Therapeutics (SRPT Free Report) has an Earnings ESP of +108.99% and a Zacks Rank #3 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Sarepta Therapeutics have gained 32.1% in the year-to-date period. SRPT’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 464.56%.

Argenx (ARGX Free Report) has an Earnings ESP of +10.00% and a Zacks Rank #3 at present.

Shares of Argenx have lost 3.1% year to date. ARGX beat earnings estimates in two of the last four quarters and missed the mark on one occasion while meeting on another, delivering an average surprise of 14.18%. ARGX is set to report first-quarter 2024 results on May 9.

Alnylam Pharmaceuticals (ALNY Free Report) has an Earnings ESP of +5.87% and a Zacks Rank #3 at present.

Shares of Alnylam have plunged 24.9% year to date. ALNY beat earnings estimates in three of the last four quarters while missing the mark on one occasion, delivering an average surprise of 45.05%.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.


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