UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report: August 12, 2020
(Date of earliest event reported)
ImmuCell Corporation
(Exact name of registrant as specified in its charter)
| DE | 001-12934 | 01-0382980 | ||
| (State or other jurisdiction
of incorporation) |
(Commission File Number) | (IRS Employer Identification Number) |
56 Evergreen Drive Portland, Maine |
04103 | |
| (Address of principal executive offices) | (Zip Code) |
207-878-2770
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act: None
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition
On August 12, 2020 ImmuCell Corporation (the "Company") issued a press release announcing unaudited financial results for the three-month and six-month periods ended June 30, 2020. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed: | ||
| 99.1 | Press Release of ImmuCell Corporation dated August 12, 2020. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| IMMUCELL CORPORATION | ||
| Date: August 12, 2020 | By: | /s/ Michael F. Brigham |
| Michael F. Brigham | ||
| President, Chief Executive Officer and Principal Financial Officer | ||
Exhibit Index
| Exhibit No. | Description |
| 99.1 | Press Release of ImmuCell Corporation dated August 12, 2020 |
Exhibit 99.1
ImmuCell
ImmuCell Announces Unaudited Financial Results for
the Second Quarter Ended June 30, 2020
For Immediate Release
PORTLAND, Maine – August 12, 2020 – 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 calves, today announced unaudited financial results for the quarter ended June 30, 2020.
Product Sales Results:
| • | Total product sales increased by 9%, or $256,000, to $3 million during the three-month period ended June 30, 2020 versus the comparable period during 2019. |
| • | Total product sales increased by 11%, or $756,000, to $7.9 million during the six-month period ended June 30, 2020 versus the comparable period during 2019. Excluding non-animal health sales (which product has since been divested) from the 2019 results, the increase in total animal health sales during the current period was 13%. |
| • | Total product sales increased by 19%, or $2.3 million, to $14.5 million during the trailing twelve-month period ended June 30, 2020 versus the trailing twelve-month period ended June 30, 2019. Excluding non-animal health sales (which product has since been divested) from the results during the trailing twelve-month period ended June 30, 2019, the increase in total animal health sales during the current period was 20%. |
Management’s Discussion:
“The COVID-19 pandemic has changed the way we operate, but our dedicated team has been flexible and creative pushing First Defense® production during these extremely difficult times and challenging work conditions,” commented Michael F. Brigham, President and CEO. “We reduced the backlog of orders to approximately $945,000 as of June 30, 2020 from approximately $1.4 million as of March 31, 2020. The investment to increase our First Defense® production capacity remains on budget and close to on-time completion, despite COVID-19 related challenges.”
“As indicated by the continued top line growth, our sales team has been able to pivot to stay safe and be successful despite COVID-19’s impact on how we work,” added Mr. Brigham. “Our first production priority is Tri-Shield First Defense® because our growth is being driven by this product format, which provides antibodies without vaccination so every calf receives a measured dose of Immediate Immunity™ against all three of the primary scour-causing pathogens, E. coli, coronavirus, and rotavirus. However, as we emphasize production of Tri-Shield®, which has a lower gross margin percentage of sales, and as we increase colostrum collection from new cows that have not been immunized previously with our proprietary vaccines, our gross margin percentage tends to decline. We expect that to improve over time.”
“Most of our product development expenses were related to the Re-Tain™ product development and commercial scale-up initiative,” concluded Mr. Brigham. “We are proceeding on plan to make our second-phased submission of the CMC Technical Section during the fourth quarter of this year, which will be subject to a six-month review by the FDA.”
Other Financial Results:
| • | Gross margin earned was 43% and 46% of total product sales during the quarters ended June 30, 2020 and 2019, respectively. |
| • | Gross margin earned was 45% and 48% of total product sales during the six-month periods ended June 30, 2020 and 2019, respectively. |
| • | Product development expenses were $1.1 million and $820,000 during the quarters ended June 30, 2020 and 2019, respectively. |
| • | Product development expenses were $2.1 million and $1.7 million during the six-month periods ended June 30, 2020 and 2019, respectively. |
| • | Approximately 91% and 89% of product development expenses for the three-month and six-month periods ended June 30, 2020, respectively, were related to the Re-Tain™ product development and commercial scale-up initiative. |
| • | Net loss was $766,000, or $0.11 per share, during the quarter ended June 30, 2020 in comparison to net loss of $627,000, or $0.09 per share, during the quarter ended June 30, 2019. | |
| • | Net loss was $888,000, or $0.12 per share, during the six-month period ended June 30, 2020 in comparison to net loss of $483,000, or $0.08 per share, during the six-month period ended June 30, 2019. | |
| • | EBITDA (a non-GAAP financial measure defined on page 4 of this press release) was ($114,000) and $74,000 during the quarters ended June 30, 2020 and 2019, respectively. | |
| • | EBITDA was $754,000 and $914,000 during the six-month periods ended June 30, 2020 and 2019, respectively. | |
| • | EBITDA was $1.2 million and $788,000 during the trailing twelve-month periods ended June 30, 2020 and 2019, respectively. |
Balance Sheet Data as of June 30, 2020:
• Cash, cash equivalents, short-term
investments and restricted cash increased to $9.6 million as of June 30, 2020 from $8.8 million as of December 31, 2019.
• Net working capital decreased
to $8.9 million as of June 30, 2020 from $10.7 million as of December 31, 2019.
• Total assets increased to
$40.7 million as of June 30, 2020 from $38.7 million as of December 31, 2019.
• Stockholders’ equity decreased to $28.3 million as of June
30, 2020 from $29 million as of December 31, 2019.
Condensed Statements of Operations (Unaudited)
During the Three-Month Periods Ended June 30, | During the Six-Month Periods Ended June 30, | |||||||||||||||
| (In thousands, except per share amounts) | 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Product sales | $ | 2,966 | $ | 2,710 | $ | 7,876 | $ | 7,120 | ||||||||
| Costs of goods sold | 1,683 | 1,461 | 4,357 | 3,670 | ||||||||||||
| Gross margin | 1,283 | 1,249 | 3,519 | 3,450 | ||||||||||||
| Sales, marketing and administrative expenses | 887 | 976 | 1,953 | 2,001 | ||||||||||||
| Product development expenses | 1,087 | 820 | 2,061 | 1,730 | ||||||||||||
| Operating expenses | 1,974 | 1,796 | 4,014 | 3,731 | ||||||||||||
| NET OPERATING LOSS | (691 | ) | (547 | ) | (495 | ) | (281 | ) | ||||||||
| Other expenses, net | 75 | 65 | 408 | 177 | ||||||||||||
LOSS BEFORE INCOME TAXES | (766 | ) | (612 | ) | (903 | ) | (458 | ) | ||||||||
| Income tax expense (benefit) | - | 15 | (15 | ) | 25 | |||||||||||
| NET LOSS | $ | (766 | ) | $ | (627 | ) | $ | (888 | ) | $ | (483 | ) | ||||
| Basic weighted average common shares outstanding | 7,213 | 7,210 | 7,213 | 6,421 | ||||||||||||
| Basic net loss per share | $ | (0.11 | ) | $ | (0.09 | ) | $ | (0.12 | ) | $ | (0.08 | ) | ||||
| Diluted weighted average common shares outstanding | 7,213 | 7,210 | 7,213 | 6,421 | ||||||||||||
| Diluted net loss per share | $ | (0.11 | ) | $ | (0.09 | ) | $ | (0.12 | ) | $ | (0.08 | ) | ||||
Non-GAAP Measures:
Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flow that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP measures included in this press release should be considered in addition to, and not as a substitute for or superior to, the comparable measure prepared in accordance with GAAP. A reader should review our Statements of Cash Flows for a detailed understanding of our sources and uses of cash. We start with our reported loss before income taxes because presently we are not paying cash for income taxes and do not anticipate paying cash for income taxes in the near-term future. We believe that considering the non-GAAP loss before income taxes and before certain non-cash expenses assists management and investors by looking at our performance across reporting periods on a consistent basis excluding these certain charges that are not uses of cash from our reported loss before income taxes. We calculate non-GAAP (loss) income before income taxes and certain non-cash expenses as indicated in the table below:
| During the Three-Month Periods Ended June 30, | During the Six-Month Periods Ended June 30, | |||||||||||||||
| (In thousands) | 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Loss before income taxes | $ | (766 | ) | $ | (612 | ) | $ | (903 | ) | $ | (458 | ) | ||||
| Depreciation, amortization and stock-based compensation | 631 | 644 | 1,367 | 1,299 | ||||||||||||
| (Loss) income before income taxes and certain non-cash expenses | $ | (135 | ) | $ | 32 | $ | 464 | $ | 841 | |||||||
The figures we have calculated and reported above do not include cash used to repay bank debt in the amounts of $142,000 and $215,000 during the three-month periods ended June 30, 2020 and 2019, respectively, and $344,000 (exclusive of the $8.3 million used to repay our refinanced bank debt) and $429,000 during the six-month periods ended June 30, 2020 and 2019, respectively. The figures calculated above differ from the calculation of Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) in two significant ways. First, we have not added back interest expense because we do pay cash for interest. Interest expense was $77,000 and $112,000 during the quarters ended June 30, 2020 and 2019, respectively, and $424,000 and $226,000 during the six-month periods ended June 30, 2020 and 2019, respectively. During the six-month period ended June 30, 2020, interest expense included payments of $165,000 to terminate our interest rate swap agreements and $95,000 to write-off debt issuance costs, both made in connection with the refinancing of our bank debt during the first quarter of 2020. Second, we have added back stock-based compensation expense because this is a non-cash expense, but it is not added back to the calculation of EBITDA. EBITDA was ($114,000) and $74,000 during the quarters ended June 30, 2020 and 2019, respectively, and $754,000 and $914,000 during the six-month periods ended June 30, 2020 and 2019, respectively.
Conference Call:
Interested parties can access the conference call scheduled by the Company to review the full second quarter 2020 financial
results by dialing (844) 855-9502 (toll free) or (412) 317-5499 (international) at 9:00 AM ET on Thursday, August 13, 2020. A teleconference
replay of the call will be available for seven days at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing
confirmation #10145671. Investors are encouraged to review the Company’s Form 10-Q for the three-month period ended June
30, 2020 that was filed with the SEC on Wednesday, August 12, 2020 and its updated Corporate Presentation slide deck that provides
an overview of the Company’s business and is available under the “Investors” tab of the Company’s website
at www.immucell.com, or by request to the Company.
About ImmuCell:
ImmuCell Corporation's (Nasdaq: ICCC) purpose is to create scientifically-proven and practical products that improve
the health and productivity of dairy and beef calves. ImmuCell manufactures and markets First Defense®,
providing Immediate Immunity™ to newborn dairy and beef calves, and is in the late stages of developing Re-Tain™,
a novel treatment for subclinical mastitis without a milk discard requirement that provides an alternative to traditional antibiotics.
Press releases and other information about the Company are available at: http://www.immucell.com.
| Contacts: | Michael F. Brigham, President and CEO |
| ImmuCell Corporation | |
| (207) 878-2770 | |
| Joe Diaz, Robert Blum and Joe Dorame | |
| Lytham Partners, LLC | |
| (602) 889-9700 | |
| iccc@lythampartners.com |
Cautionary Note 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: our plans and strategies for our business; projections of future financial or operational performance; the timing and outcome of pending or anticipated applications for regulatory approvals; factors that may affect the dairy and beef industries and future demand for our products; the extent, nature and duration of the COVID-19 pandemic and its consequences, and their direct and indirect impacts on the Company’s production activities, operating results and financial condition and on the customers and markets the Company serves; 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 and producers’ level of interest in treating subclinical mastitis given the current economic and market conditions; 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 anticipated costs of (or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects; the continuing availability to us on reasonable terms of third-party providers of critical products or services; the robustness of our manufacturing processes and related technical issues; estimates about our production capacity, efficiency and yield; the future adequacy of our working capital and the availability and cost of third-party financing; the forgiveness of our repayment obligations with respect to the loan we received under the CARES Act; future regulatory requirements relating to our products; future expense ratios and margins; future compliance with bank debt covenants; 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 Nisin Drug Substance; implementation of international trade tariffs that could reduce the export of dairy products, which could in turn weaken the price received by our customers for their products; 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; the value of our net deferred tax assets; projections about depreciation expense and its impact on income for book and tax return purposes; anticipated 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”, “seeks” 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 (including the First Defense® product line and Re-Tain™), competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand, our reliance upon third parties for financial support, products and services, changes in laws and regulations, decision making and delays by regulatory authorities, currency values and fluctuations and other risks detailed from time to time in filings we make with the SEC, 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 involve risks and uncertainties and are based on our current expectations, but actual results may differ materially due to various factors, including the risk factors summarized above.