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Ocugen (OCGN) to Report Q2 Earnings: What's in the Cards?
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Ocugen, Inc. (OCGN - Free Report) is likely to provide updates on its pipeline developments when it reports second-quarter 2021 results on Aug 6.
The company has a disappointing earnings surprise history, having missed expectations in three of the trailing four quarters. Its average four-quarter negative earnings surprise was 297.1%. The negative surprise in the last reported quarter was 108%.
Shares of Ocugen have surged 274.3% so far this year against the industry‘s 1.3% decline.
Image Source: Zacks Investment Research
Let’s see how things have shaped up for this announcement.
Factors to Note
With no marketed drugs in its portfolio, Ocugen is unlikely to have recorded any revenues during the second quarter. Furthermore, the company has no clinical-stage candidates in its portfolio.
In February 2021, Ocugen and India-based Bharat Biotech entered into a definitive agreement to co-develop, supply and commercialize Bharat Biotech’s COVAXIN — an advanced-stage whole-virion inactivated COVID-19 vaccine candidate — for the U.S. market. In June 2021, the purview of the agreement was expanded to include the Canadian market.
Ocugen was initially working with both U.S. and Canadian regulatory authorities to develop the regulatory pathway for an emergency use for COVAXIN. However, the company will now pursue submission of a biologics license application (BLA) for its COVID-19 vaccine instead of going for an emergency use in the United States. The change in submission is based on recommendation received from the FDA, and its request for additional data and information. The company is in discussion with the FDA to understand the data requirements and anticipates an additional clinical study to support the BLA submission.
In July 2021, the company announced that Bharat Biotech shared positive results from the phase III study of COVAXIN, which demonstrated an efficacy of 77.8% in mild, moderate and severe COVID-19 disease and an efficacy of 93.4% against severe COVID-19 disease. It also announced that the virus demonstrated efficacy against several SARS-COV-2 variants including efficacy data of 65.2% against the delta variant.
Investor focus will be on COVAXIN-related developments on the company’s earnings call.
Ocugen’s operating expenses are likely to have increased in the quarter under review due to costs related to preparation of IND filing and initiation of the clinical studies.
What Our Model Indicates
Our proven model does not conclusively predict an earnings beat for Ocugen this earnings season. 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. But that is not the case here as you will see below.
Earnings ESP: Ocugen has an Earnings ESP of -20.00% as the Most Accurate Estimate of a loss of 4 cents per share is wider than the Zacks Consensus Estimate of a loss of 3 cents. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: The company currently carries a Zacks Rank #4 (Sell).
Image: Bigstock
Ocugen (OCGN) to Report Q2 Earnings: What's in the Cards?
Ocugen, Inc. (OCGN - Free Report) is likely to provide updates on its pipeline developments when it reports second-quarter 2021 results on Aug 6.
The company has a disappointing earnings surprise history, having missed expectations in three of the trailing four quarters. Its average four-quarter negative earnings surprise was 297.1%. The negative surprise in the last reported quarter was 108%.
Shares of Ocugen have surged 274.3% so far this year against the industry‘s 1.3% decline.
Image Source: Zacks Investment Research
Let’s see how things have shaped up for this announcement.
Factors to Note
With no marketed drugs in its portfolio, Ocugen is unlikely to have recorded any revenues during the second quarter. Furthermore, the company has no clinical-stage candidates in its portfolio.
In February 2021, Ocugen and India-based Bharat Biotech entered into a definitive agreement to co-develop, supply and commercialize Bharat Biotech’s COVAXIN — an advanced-stage whole-virion inactivated COVID-19 vaccine candidate — for the U.S. market. In June 2021, the purview of the agreement was expanded to include the Canadian market.
Ocugen was initially working with both U.S. and Canadian regulatory authorities to develop the regulatory pathway for an emergency use for COVAXIN. However, the company will now pursue submission of a biologics license application (BLA) for its COVID-19 vaccine instead of going for an emergency use in the United States. The change in submission is based on recommendation received from the FDA, and its request for additional data and information. The company is in discussion with the FDA to understand the data requirements and anticipates an additional clinical study to support the BLA submission.
In July 2021, the company announced that Bharat Biotech shared positive results from the phase III study of COVAXIN, which demonstrated an efficacy of 77.8% in mild, moderate and severe COVID-19 disease and an efficacy of 93.4% against severe COVID-19 disease. It also announced that the virus demonstrated efficacy against several SARS-COV-2 variants including efficacy data of 65.2% against the delta variant.
Investor focus will be on COVAXIN-related developments on the company’s earnings call.
Ocugen’s operating expenses are likely to have increased in the quarter under review due to costs related to preparation of IND filing and initiation of the clinical studies.
What Our Model Indicates
Our proven model does not conclusively predict an earnings beat for Ocugen this earnings season. 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. But that is not the case here as you will see below.
Earnings ESP: Ocugen has an Earnings ESP of -20.00% as the Most Accurate Estimate of a loss of 4 cents per share is wider than the Zacks Consensus Estimate of a loss of 3 cents. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: The company currently carries a Zacks Rank #4 (Sell).
Ocugen, Inc. Price
Ocugen, Inc. price | Ocugen, Inc. Quote
Stocks to Consider
Here are some biotech/drug stocks that have the right mix of elements to beat on earnings this time around:
Ironwood (IRWD - Free Report) has an Earnings ESP of +11.11% and a Zacks Rank #2.
Moderna (MRNA - Free Report) has an Earnings ESP of +24.12% and a Zacks Rank #3. You can see the complete list of today’s Zacks #1 Rank stocks here.
Prothena Corporation (PRTA - Free Report) has an Earnings ESP of +25.66% and a Zacks Rank #3.