Biotechnology,
Pharmaceutical,
Health,
Organic Process Research & Development,
Depreciation,
Straight-through processing,
EBITDA,
GAAP,
Cyprus Securities and Exchange Commission,
Marketing,
ANI,
Insurance,
Bookkeeping,
Telescopic sight Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin Gel pre-launch charges and sales and marketing expenses from its non-GAAP results.
Key Points:
- Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin Gel pre-launch charges and sales and marketing expenses from its non-GAAP results.
- A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.
- A reconciliation of adjusted non-GAAP net income (loss) to the most directly comparable GAAP financial measure is provided below.
- A reconciliation of adjusted non-GAAP diluted (loss)/earnings per share to the most directly comparable GAAP financial measure is provided below.
Professional Services,
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Communications,
Finance,
Pharmaceutical,
Biotechnology,
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Pharmaceutical industry,
Management ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its first quarter 2023 financial results on Monday, May 8, 2023, prior to the market open.
Key Points:
- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its first quarter 2023 financial results on Monday, May 8, 2023, prior to the market open.
- Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:
Retrieved on:
Wednesday, April 26, 2023
Finance,
Public Relations,
Investor Relations,
Communications,
Professional Services,
Biotechnology,
Other Health,
Health,
Pharmaceutical,
General Health,
Conference,
ANI,
Financial services,
Management ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will present at the H.C. Wainwright BioConnect Investor Conference at the NASDAQ Headquarters in New York City as follows:
Key Points:
ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will present at the H.C. Wainwright BioConnect Investor Conference at the NASDAQ Headquarters in New York City as follows:
Biotechnology,
FDA,
Pharmaceutical,
Health,
Abbreviated New Drug Application,
ANI,
Food and Drug Administration,
RLD,
ANDA,
Food,
Pharmaceutical industry ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Nitrofurantoin Oral Suspension USP, 25 mg/5 ml.
Key Points:
- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Nitrofurantoin Oral Suspension USP, 25 mg/5 ml.
- ANI’s Nitrofurantoin Oral Suspension is the generic version of the Reference Listed Drug (RLD) Furadantin® Oral Suspension 25 mg/5 ml.
- The current annual U.S. market for Nitrofurantoin Oral Suspension is approximately $55.5 million, according to the latest estimates by IQVIA/IMS Health, a leading healthcare data and analytics provider.
- The FDA approval and commercialization of Nitrofurantoin Oral Suspension is another example of how we are continuing to bring limited-competition products to market, with the goal of serving the patient populations that can benefit,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
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Generic drug,
Colestipol ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g.
Key Points:
- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g.
ANI’s Colestipol Hydrochloride Tablets are the generic version of the Reference Listed Drug (RLD) Colestid®.
- The current annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
- "We are pleased to expand our generics portfolio with the launch of Colestipol, bringing to market a product with a limited number of suppliers.
- We remain committed to providing patients access to high-quality medicines,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
Biotechnology,
Pharmaceutical,
Health,
Cyprus Securities and Exchange Commission,
ANI,
GAAP,
Process capital,
EBITDA,
Marketing,
Depreciation,
Organic Process Research & Development,
Insurance,
Bookkeeping,
Telescopic sight Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin pre-launch charges and sales and marketing expenses from its non-GAAP results.
Key Points:
- Beginning in the fourth quarter of 2022, ANI no longer excludes expense for In-Process Research & Development or Cortrophin pre-launch charges and sales and marketing expenses from its non-GAAP results.
- These changes have been made to align with views expressed by the U.S. Securities and Exchange Commission.
- A reconciliation of adjusted non-GAAP net (loss)/income to the most directly comparable GAAP financial measure is provided below.
- A reconciliation of adjusted non-GAAP diluted (loss)/earnings per share to the most directly comparable GAAP financial measure is provided below.
Retrieved on:
Wednesday, February 22, 2023
Finance,
Public Relations,
Investor Relations,
Communications,
Professional Services,
Biotechnology,
Other Health,
Health,
Pharmaceutical,
General Health,
Senior,
Pharmaceutical industry,
Management ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its fourth quarter and full year 2022 financial results on Thursday, March 9, 2023, prior to market open.
Key Points:
- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its fourth quarter and full year 2022 financial results on Thursday, March 9, 2023, prior to market open.
- Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:
Retrieved on:
Monday, December 19, 2022
FDA,
Health,
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Biotechnology,
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Tablet,
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Nature,
Risk,
FDA,
Failure,
News,
ANDA,
Annual report,
ANI,
Abbreviated New Drug Application,
Regulation of tobacco by the U.S. Food and Drug Administration,
Pharmaceutical industry ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Levocarnitine Tablets USP, 330 mg.
Key Points:
- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Levocarnitine Tablets USP, 330 mg.
ANI’s Levocarnitine Tablets are the generic version of the Reference Listed Drug (RLD) Carnitor®.
- The current annual U.S. market for Levocarnitine Tablets is approximately $10.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
- "The launch of Levocarnitine Tablets is another example of ANI’s commitment to increasing patient access to affordable, high-quality medicines and aligns with our goal of bringing limited-competition products to market,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
- ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.
Retrieved on:
Monday, November 28, 2022
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Food,
Risk,
ANDA,
RLD,
Patient,
Regulation of tobacco by the U.S. Food and Drug Administration,
Fluoxetine,
Food and Drug Administration,
Security (finance),
Annual report,
News,
Failure,
ANI,
Form 10-K,
FDA,
USP,
Pharmaceutical industry ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20 mg/5 mL.
Key Points:
- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20 mg/5 mL.
- ANIs Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac.
- The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
- ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.
Retrieved on:
Wednesday, November 16, 2022
Health,
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Form 10-K,
Food and Drug Administration,
Regulation of tobacco by the U.S. Food and Drug Administration,
Growth,
ANDA,
COVID-19,
Tablet,
ANI,
Risk,
Pharmaceutical industry ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Trimethoprim Tablets USP, 100 mg.
Key Points:
- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Trimethoprim Tablets USP, 100 mg.
ANIs Trimethoprim Tablets are the generic version of the Reference Listed Drug (RLD) of the same established name.
- The current annual U.S. market for Trimethoprim Tablets is approximately $16.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
- "As we continue to focus on bringing niche limited-competition products to market, we are pleased to announce the FDA approval and commercialization of Trimethoprim Tablets, stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
- ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.
