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ImmuCell Announces Financial Results for Second Quarter of 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
By: Nasdaq / GlobeNewswire - 13 Aug 2018 | Back to overview list |
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PORTLAND, Maine, Aug. 13, 2018 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle, today announced its financial results for the quarter ended June 30, 2018. Management Discussion: Second Quarter Sales Results:
Management Discussion (continued): Additional Second Quarter Results:
These increased expenses were incurred as the Company invested to gain regulatory approval to launch its new products.
During the second quarter of 2018, the Company recorded non-cash income tax expense of approximately $563,000 to record a full valuation allowance against its net deferred tax assets. This reserve was required given that the Company is currently incurring a net loss and projects additional net losses in the near term, largely due to a lower gross margin on sales and ongoing development costs necessary to bring its new products to market. However, the Company believes that it will return to profitability and utilize these assets before they expire.
Balance Sheet Data as of June 30, 2018:
The Company estimates that only approximately $125,000 remains to be spent on its Nisin production facility as of June 30, 2018, which would complete the project just under its $21 million budget. During the third quarter of 2018, it initiated production of the registration batches required for FDA approval of its Nisin-based intramammary treatment for subclinical mastitis without a milk discard. The first phased Nisin Drug Substance CMC Technical Section submission to the FDA is anticipated at the end of the third quarter or early in the fourth quarter of 2018. A second phased submission, which would include responses to the first phased review and the Drug Product data, is expected to be filed in the middle of 2019. This timeline supports obtaining FDA approval by late 2019 or during the first half of 2020. Non-GAAP Measures:
Conference Call: About ImmuCell: Financial Tables to Follow
Unaudited Selected Balance Sheet Data (In thousands)
Cautionary Statement Regarding Forward-looking Statements (Safe Harbor Statement): This Press Release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to: projections of future financial performance; the value of our deferred tax assets; projections about depreciation expense and its impact on income for book and tax return purposes; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis; the expected efficacy of new products; estimates about the market size for our products; future market share of and revenue generated by current products and products still in development; our ability to increase production output and reduce costs of goods sold associated with our new product, Tri-Shield™ First Defense®; the future adequacy of our own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products on a timely basis; the efficiency and effectiveness of our manufacturing processes and related technical issues; estimates about our production capacity; the future adequacy of our working capital and the availability and cost of third party financing; the timing and outcome of pending or anticipated applications for regulatory approvals; future regulatory requirements relating to our products; future expense ratios and margins; future compliance with bank debt covenants; future cost of our variable interest rate exposure on most of our bank debt; costs associated with sustaining compliance with current Good Manufacturing Practice (cGMP) regulations in our current operations and attaining such compliance for the facility to produce the Drug Substance; factors that may affect the dairy and beef industries and future demand for our products; implementation of international trade tariffs that could reduce the export of dairy products weakening the price received by our customers for their product; our effectiveness in competing against competitors within both our existing and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures and resources; anticipated changes in our manufacturing capabilities and efficiencies; anticipated competitive and market conditions; and any other statements that are not historical facts. Forward-looking statements can be identified by the use of words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts” and similar words and expressions. In addition, there can be no assurance that future developments affecting us will be those that we anticipate. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of our products, competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand, the uncertainties associated with product development and Drug Substance manufacturing, our potential reliance upon third parties for financial support, products and services, changes in laws and regulations, decision making by regulatory authorities, possible dilutive impacts on existing stockholders from any equity financing transactions in which we may engage, currency values and fluctuations and other risks detailed from time to time in filings we make with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements are based on our current expectations, but actual results may differ materially due to various factors, including the risk factors discussed above. Contacts: Michael F. Brigham, President and CEO Joe Diaz, Robert Blum and Joe Dorame |
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |