ImmuCell Announces Unaudited Financial Results for the Quarter Ended June 30, 2024
ImmuCell (Nasdaq: ICCC) announced unaudited financial results for Q2 2024. Highlights include:
- Product sales increased 55% to $5.5 million in Q2 2024 vs Q2 2023
- Product sales up 82% to $12.7 million for H1 2024 vs H1 2023
- Trailing twelve-month product sales grew 48% to $23.2 million
Despite sales growth, the company reported a net loss of $1.5 million in Q2 2024. Gross margin declined to 22% in Q2 2024 from 30% in Q2 2023. The company aims to produce finished goods worth $12 million+ every six months, targeting 80%+ of its estimated $30 million annual production capacity.
ImmuCell is working to resolve production contamination issues and improve yields. The FDA issued an Incomplete Letter for the Re-Tain® product, requiring resolution of inspectional observations at the contract manufacturer before resubmission.
ImmuCell (Nasdaq: ICCC) ha annunciato i risultati finanziari non auditati per il secondo trimestre del 2024. I punti salienti includono:
- Le vendite di prodotti sono aumentate del 55% a 5,5 milioni di dollari nel Q2 2024 rispetto al Q2 2023
- Le vendite di prodotti sono aumentate dell'82% a 12,7 milioni di dollari per il primo semestre del 2024 rispetto al primo semestre del 2023
- Le vendite di prodotti negli ultimi dodici mesi sono cresciute del 48% a 23,2 milioni di dollari
Nonostante la crescita delle vendite, l'azienda ha riportato una perdita netta di 1,5 milioni di dollari nel Q2 2024. Il margine lordo è diminuito al 22% nel Q2 2024 rispetto al 30% nel Q2 2023. L'azienda mira a produrre beni finiti per un valore di oltre 12 milioni di dollari ogni sei mesi, puntando a oltre l'80% della sua capacità produttiva annuale stimata di 30 milioni di dollari.
ImmuCell sta lavorando per risolvere problemi di contaminazione nella produzione e migliorare i rendimenti. La FDA ha emesso una Lettera Incompleta per il prodotto Re-Tain®, richiedendo di risolvere le osservazioni ispettive presso il produttore contrattato prima della nuova presentazione.
ImmuCell (Nasdaq: ICCC) anunció resultados financieros no auditados para el segundo trimestre de 2024. Los aspectos más destacados incluyen:
- Las ventas de productos aumentaron un 55% a 5,5 millones de dólares en el Q2 2024 en comparación con el Q2 2023
- Las ventas de productos aumentaron un 82% a 12,7 millones de dólares para el H1 2024 en comparación con el H1 2023
- Las ventas de productos en los últimos doce meses crecieron un 48% a 23,2 millones de dólares
A pesar del crecimiento en las ventas, la empresa reportó una pérdida neta de 1,5 millones de dólares en el Q2 2024. El margen bruto disminuyó al 22% en el Q2 2024 desde el 30% en el Q2 2023. La empresa tiene como objetivo producir bienes terminados por un valor de más de 12 millones de dólares cada seis meses, apuntando a más del 80% de su capacidad de producción anual estimada de 30 millones de dólares.
ImmuCell está trabajando para resolver problemas de contaminación en la producción y mejorar los rendimientos. La FDA emitió una Carta Incompleta para el producto Re-Tain®, requiriendo la resolución de observaciones de inspección en el fabricante contratado antes de la nueva presentación.
ImmuCell (Nasdaq: ICCC)는 2024년 2분기 비감사 재무 결과를 발표하였습니다. 주요 내용은 다음과 같습니다:
- 제품 판매가 2023년 2분기 대비 2024년 2분기에 55% 증가하여 550만 달러에 달함
- 2023년 상반기 대비 2024년 상반기 제품 판매가 82% 증가하여 1270만 달러로 증가함
- 지난 12개월간 제품 판매가 48% 증가하여 2320만 달러에 이름
판매 성장에도 불구하고, 회사는 2024년 2분기에 150만 달러의 순손실을 보고하였습니다. 총 마진은 2023년 2분기 30%에서 2024년 2분기 22%로 감소하였습니다. 회사는 6개월마다 1200만 달러 이상의 완제품을 생산할 계획이며, 연간 약 3000만 달러의 생산 능력의 80% 이상을 목표하고 있습니다.
ImmuCell은 생산 오염 문제를 해결하고 수율을 개선하기 위해 노력하고 있습니다. FDA는 Re-Tain® 제품에 대해 불완전 편지를 발송하였으며, 재제출 전에 계약 제조업체의 검사 관찰사항을 해결해야 합니다.
ImmuCell (Nasdaq: ICCC) a annoncé des résultats financiers non audités pour le deuxième trimestre de 2024. Les faits marquants incluent :
- Les ventes de produits ont augmenté de 55 % pour atteindre 5,5 millions de dollars au Q2 2024 par rapport au Q2 2023
- Les ventes de produits ont augmenté de 82 % pour atteindre 12,7 millions de dollars pour le H1 2024 par rapport au H1 2023
- Les ventes de produits sur les douze derniers mois ont crû de 48 % pour atteindre 23,2 millions de dollars
Malgré la croissance des ventes, l'entreprise a enregistré une perte nette de 1,5 million de dollars au Q2 2024. La marge brute a chuté à 22 % au Q2 2024 contre 30 % au Q2 2023. L'entreprise vise à produire des biens finis d'une valeur de plus de 12 millions de dollars tous les six mois, avec l'objectif de réaliser plus de 80 % de sa capacité de production annuelle estimée de 30 millions de dollars.
ImmuCell travaille à résoudre les problèmes de contamination en production et à améliorer les rendements. La FDA a émis une lettre incomplète pour le produit Re-Tain®, nécessitant la résolution des observations d'inspection auprès du fabricant sous contrat avant la nouvelle soumission.
ImmuCell (Nasdaq: ICCC) hat nicht testierte Finanzdaten für das zweite Quartal 2024 bekannt gegeben. Zu den Höhepunkten gehören:
- Die Produktverkäufe stiegen im Q2 2024 im Vergleich zum Q2 2023 um 55% auf 5,5 Millionen US-Dollar
- Die Produktverkäufe stiegen im H1 2024 im Vergleich zum H1 2023 um 82% auf 12,7 Millionen US-Dollar
- Die Produktverkäufe der letzten zwölf Monate wuchsen um 48% auf 23,2 Millionen US-Dollar
Trotz des Verkaufswachstums berichtete das Unternehmen im Q2 2024 von einem Nettogewinnverlust von 1,5 Millionen US-Dollar. Die Bruttomarge sank im Q2 2024 auf 22% von 30% im Q2 2023. Das Unternehmen strebt an, alle sechs Monate Fertigwaren im Wert von über 12 Millionen US-Dollar zu produzieren, mit dem Ziel, mehr als 80% seiner geschätzten jährlichen Produktionskapazität von 30 Millionen US-Dollar zu erreichen.
ImmuCell arbeitet daran, Produktionskontaminationsprobleme zu lösen und die Erträge zu verbessern. Die FDA hat einen unvollständigen Brief für das Produkt Re-Tain® ausgestellt, der die Behebung von Inspektionsobservationen beim Vertragshersteller vor der erneuten Einreichung erfordert.
- Product sales increased 55% year-over-year in Q2 2024
- Product sales grew 82% for the first half of 2024 compared to 2023
- Trailing twelve-month product sales increased 48% to $23.2 million
- Finished goods production reached $12.7 million in H1 2024, annualizing to 85% of estimated capacity
- Cash and cash equivalents increased to $1.3 million from $979,000 at year-end 2023
- Net loss of $1.5 million in Q2 2024, compared to $1.4 million loss in Q2 2023
- Gross margin declined to 22% in Q2 2024 from 30% in Q2 2023
- EBITDA decreased to negative $717,000 in Q2 2024 from negative $605,000 in Q2 2023
- Net working capital decreased to $6.2 million from $7.3 million at year-end 2023
- FDA issued Incomplete Letter for Re-Tain® product, delaying regulatory progress
ImmuCell's Q2 2024 results show significant top-line growth, with product sales increasing
The company's production capacity expansion has been successful, reaching about
ImmuCell's core product, First Defense®, is driving sales growth, but the company faces hurdles with its new product, Re-Tain®. The FDA's Incomplete Letter for Re-Tain's CMC Technical Section submission is a setback, potentially delaying market entry. This highlights the regulatory risks inherent in biotech product development.
The company's focus on production remediation to address contamination issues is critical. While necessary, these efforts are impacting profitability in the short term. The initiatives to improve yield in coming quarters will be important to watch. The backlog reduction from
PORTLAND, Maine, Aug. 13, 2024 (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 unaudited financial results for the quarter ended June 30, 2024.
Q2 2024 Highlights:
- Product sales increased
55% versus the comparable quarter in 2023. - Product sales increased
82% versus the comparable six-month period in 2023. - Product sales increased
48% from the previous trailing twelve-month period ended June 30, 2023.
Management’s Discussion:
“Our preliminary, unaudited product sales for the second quarter of 2024 were first reported on July 9, 2024,” commented Michael F. Brigham, President and CEO of ImmuCell. “We have no changes to those figures.”
After a slowdown during 2023 that was necessary to remediate certain production contamination events, the Company’s objective is to produce finished goods with an approximate sales value of
“As reflected in our top-line sales growth, we have largely achieved our current production capacity expansion goals, but this has come with some contamination and yield losses that have resulted in very low gross margin,” continued Mr. Brigham. “We believe that we have implemented remediation steps that will keep the bioburden within specification, and we have several important initiatives underway to improve yield over the coming quarters.”
The backlog of orders was worth approximately
Certain Financial Results:
- Product sales increased by
55% , or$1.9 million , to$5.5 million during the three-month period ended June 30, 2024 compared to$3.5 million during the three-month period ended June 30, 2023. - Product sales increased by
82% , or$5.8 million , to$12.7 million during the six-month period ended June 30, 2024 compared to$7 million during the six-month period ended June 30, 2023. - Product sales increased by
48% , or$7.5 million , to$23.2 million during the trailing twelve-month period ended June 30, 2024 compared to$15.7 million during the trailing twelve-month period ended June 30, 2023. - Gross margin earned was
22% and30% of product sales during the three-month periods ended June 30, 2024 and 2023, respectively. Gross margin earned was28% and19% of product sales during the six-month periods ended June 30, 2024 and 2023, respectively. - Net loss was
$1.5 million , or$0.20 per basic share, during the three-month period ended June 30, 2024 in comparison to a net loss of$1.4 million , or$0.18 per basic share, during the three-month period ended June 30, 2023. Net loss was$2 million , or$0.25 per basic share, during the six-month period ended June 30, 2024 in comparison to a net loss of$3.7 million , or$0.48 per basic share during the six-month period ended June 30, 2023. - EBITDA (a non-GAAP financial measure described on page 5 of this press release) decreased to approximately negative
$717,000 during the three-month period ended June 30, 2024 in comparison to approximately negative$605,000 during the three-month period ended June 30, 2023. EBITDA improved to approximately negative$340,000 during the six-month period ended June 30, 2024 in comparison to approximately negative$2.2 million during the six-month period ended June 30, 2023.
Balance Sheet Data as of June 30, 2024:
- Cash and cash equivalents increased to
$1.3 million as of June 30, 2024 from$979,000 as of December 31, 2023, with no draw outstanding on the available$1 million line of credit as of these dates. - Net working capital decreased to approximately
$6.2 million as of June 30, 2024 from$7.3 million as of December 31, 2023. - Stockholders’ equity decreased to
$23.5 million as of June 30, 2024 from$25 million as of December 31, 2023.
Status of Re-Tain® Product Development Initiative:
In May of 2024, the FDA issued a CMC Technical Section Incomplete Letter (Incomplete Letter) to the Company in response to its third CMC Technical Section submission for Re-Tain®. Pursuant to the Incomplete Letter, the FDA provided some minor requests pertaining to the Company’s submission requiring a re-submission of the CMC Technical Section, which is typically subject to a six-month review. However, the FDA has indicated that this re-submission potentially could be handled through a shortened review period because the open items are not complex. More critical to the timeline, however, is that the FDA has also required that the Company not re-submit the CMC Technical Section until inspectional observations at the facilities of its Drug Product (DP) contract manufacturer are resolved. The DP contract manufacturer has submitted responses to the inspectional observations and is awaiting next steps for disposition by the FDA.
“We will remain focused on the commercial opportunity we have with First Defense®, and we intend to persist through what we see as the final regulatory steps in our effort to bring Re-Tain® to market,” Mr. Brigham concluded.
Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):
This Press Release and the statements to be made in the related conference call referenced herein contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts, and will often include words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. Such statements include, but are not limited to, any forward-looking 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; future demand for our products; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the expected efficacy or impact 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 per unit; the 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 efficacy or timeline to complete our contamination remediation efforts; the likelihood, severity or impact of future contamination events; the robustness of our manufacturing processes and related technical issues; estimates about our production capacity, efficiency and yield; the salability of products currently held in inventory pending regulatory approval; future regulatory requirements relating to our products; future expense ratios and margins; the effectiveness of our investments in our business; anticipated changes in our manufacturing capabilities and efficiencies; our effectiveness in competing against competitors within both our existing and our anticipated product markets; and any other statements that are not historical facts. These statements are intended to provide management's current expectation of future events as of the date of this Press Release, are based on management's estimates, projections, beliefs and assumptions as of the date hereof; and are not guarantees of future performance. Such statements involve known and unknown risks and uncertainties that may cause the Company's actual results, financial or operational performance or achievements to be materially different from those expressed or implied by these forward-looking statements, 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 (including the consequences of backlogs), uncertainty associated with the timing and volume of customer orders as we come out of a prolonged backlog, adverse impacts of supply chain disruptions on our operations and customer and supplier relationships, commercial and operational risks relating to our current and planned expansion of production capacity, and other risks and uncertainties detailed from time to time in filings we make with the Securities and Exchange Commission (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. In addition, there can be no assurance that future risks, uncertainties or developments affecting us will be those that we anticipate. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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) | 2024 | 2023 | 2024 | 2023 | |||||||||||
| Product sales | |||||||||||||||
| Costs of goods sold | 4,243 | 2,489 | 9,204 | 5,634 | |||||||||||
| Gross margin | 1,230 | 1,044 | 3,526 | 1,345 | |||||||||||
| Product development expenses | 1,031 | 1,100 | 2,293 | 2,210 | |||||||||||
| Sales, marketing and administrative expenses | 1,586 | 1,248 | 2,920 | 2,696 | |||||||||||
| Operating expenses | 2,617 | 2,348 | 5,213 | 4,906 | |||||||||||
| NET OPERATING LOSS | (1,387 | ) | (1,304 | ) | (1,687 | ) | (3,561 | ) | |||||||
| Other expenses, net | 143 | 74 | 280 | 131 | |||||||||||
| LOSS BEFORE INCOME TAXES | (1,530 | ) | (1,378 | ) | (1,967 | ) | (3,692 | ) | |||||||
| Income tax expense | 2 | 2 | 2 | 3 | |||||||||||
| NET LOSS | ( | ) | ( | ) | ( | ) | ( | ) | |||||||
| Basic weighted average common shares outstanding | 7,810 | 7,747 | 7,780 | 7,747 | |||||||||||
| Basic net loss per share | ( | ) | ( | ) | ( | ) | ( | ) | |||||||
| Diluted weighted average common shares outstanding | 7,810 | 7,747 | 7,780 | 7,747 | |||||||||||
| Diluted net loss per share | ( | ) | ( | ) | ( | ) | ( | ) | |||||||
Selected Balance Sheet Data (In thousands) (Unaudited)
| As of June 30, 2024 | As of December 31, 2023 | |||||
| Cash and cash equivalents | ||||||
| Net working capital | 6,237 | 7,272 | ||||
| Total assets | 41,855 | 43,808 | ||||
| Stockholders’ equity | ||||||
Non-GAAP Financial 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. We believe that considering the non-GAAP measure of Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) 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 EBITDA as described in the following table:
| During the Three-Month Periods Ended June 30, | During the Six-Month Periods Ended June 30, | ||||||||||||||
| (In thousands) | 2024 | 2023 | 2024 | 2023 | |||||||||||
| Loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | |||||||
| Interest expense (excluding debt issuance and debt discount costs) | 132 | 87 | 267 | 175 | |||||||||||
| Depreciation | 666 | 680 | 1,329 | 1,333 | |||||||||||
| Amortization | 15 | 6 | 31 | 13 | |||||||||||
| EBITDA | ( | ) | ( | ) | ( | ) | ( | ) | |||||||
EBITDA included stock-based compensation expense (which is a non-cash expense that management adds back to EBITDA when assessing its cash flows) of approximately
Conference Call:
The Company is planning to host a conference call on Wednesday, August 14, 2024 at 9:00 AM ET to discuss the unaudited financial results for the quarter ended June 30, 2024. Interested parties can access the conference call by dialing (844) 855-9502 (toll free) or (412) 317-5499 (international). A teleconference replay of the call will be available until August 21, 2024 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #3744296. Investors are encouraged to review the Company’s 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. An updated version of the slide deck will be made available under the “Investors” tab of the Company’s website after the market closes on Tuesday, August 13, 2024.
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 cattle. 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 in dairy cows without FDA-required milk discard or meat withhold label restrictions 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 | |
FAQ
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