Full Press Release Details
ANI Pharmaceuticals Reports Third Quarter Results
For the third quarter 2019:
Baudette, Minnesota (November 6, 2019) - ANI Pharmaceuticals,
Inc. ("ANI") (NASDAQ: ANIP) today reported its financial results for the three and nine months ended September
30, 2019 and updated its 2019 financial guidance for net revenues, adjusted non-GAAP EBITDA and adjusted non-GAAP earnings per
share. The Company will host its earnings conference call this morning, November 6, 2019, at 10:30 AM ET. Investors and other interested
parties can join the call by dialing (866) 776-8875. The conference ID is 2599456.
| (in thousands, except per share data) | Q3 2019 | Q3 2018 | YTD 2019 (a) | YTD 2018 (a) | ||||||||||||
| Net revenues | $ | 51,337 | $ | 50,703 | $ | 158,581 | $ | 144,454 | ||||||||
| Net income | $ | 3,895 | $ | 5,037 | $ | 10,929 | $ | 10,064 | ||||||||
| GAAP earnings per diluted share | $ | 0.32 | $ | 0.42 | $ | 0.89 | $ | 0.85 | ||||||||
| Adjusted non-GAAP EBITDA (b) | $ | 19,795 | $ | 21,429 | $ | 65,775 | $ | 62,217 | ||||||||
| Adjusted non-GAAP diluted earnings per share (c) | $ | 1.23 | $ | 1.29 | $ | 3.98 | $ | 3.74 |
(a) See ANI's Form 10-Q filed November 6, 2019
for discussion of year-to-date results.
(b) See Table 3 for US GAAP reconciliation.
(c) See Table 4 for US GAAP reconciliation.
Arthur S. Przybyl, President and CEO, stated,
"In the third quarter, we reached a significant
milestone in our Cortrophin Gel re-commercialization program when we announced positive clinical data from our cortisol dose
response study. It was also the first time we dosed human volunteers with our finished dosage form Cortrophin Gel drug. We
continue to meet our Cortrophin development milestones and remain on track to file our supplemental NDA in March of 2020.
Recently, we launched our fourth and fifth generic
products of 2019. In September, we launched Vancomycin HCl for Oral Solution, and in October, we launched Aspirin and Extended
Release Dipyridamole Capsules. Vancomycin HCl for Oral Solution represents a meaningful revenue opportunity and provides an FDA
approved and easy to administer alternative to a market that is largely serviced by compounding pharmacies. Lastly, we recently
announced plans to launch Bretylium Tosylate Injection, USP 500mg / 10ml in December. This product is an important life-saving
cardiac drug that provides physicians a valuable tool to treat patients with ventricular arrhythmias in an emergency setting."
ANI Updates Guidance for the Full Year 2019
ANI has updated its full year guidance for net revenues, adjusted
non-GAAP EBITDA and adjusted non-GAAP earnings per share in order to reflect additional competition against two of its important
ANI's estimates are based upon actual results for the
nine months ending September 30, 2019 and projected results for the remaining three months of the year. ANI's full year 2019
financial guidance reflects management's current assumptions regarding customer relationships, product pricing, prescription
trends, competition, inventory levels, cost of sales, operating costs, timing of research and development spend, taxes, and the
anticipated timing of future product launches and other key events. For the twelve months ending December 31, 2019, ANI is providing
guidance on net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share.
The following table summarizes 2019 guidance:
($ in millions except per share data)
| 2019 Guidance | ||
| Net Revenues | $209.0 to $212.0 | |
| Adjusted non-GAAP EBITDA | $84.7 to $86.8 | |
| Adjusted non-GAAP diluted earnings per share | $5.06 to $5.23 |
Third Quarter Results
| Net Revenues (in thousands) | Three Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | Change | % Change | |||||||||||||
| Generic pharmaceutical products | $ | 31,753 | $ | 30,287 | $ | 1,466 | 5 | % | ||||||||
| Branded pharmaceutical products | 16,605 | 14,589 | 2,016 | 14 | % | |||||||||||
| Contract manufacturing | 2,376 | 2,826 | (450 | ) | (16 | )% | ||||||||||
| Royalty and other | 603 | 3,001 | (2,398 | ) | (80 | )% | ||||||||||
| Total net revenues | $ | 51,337 | $ | 50,703 | $ | 634 | 1 | % |
Generic Pharmaceutical Products
Third Quarter Net Revenues - Results and Update
Net revenues from sales of generic pharmaceuticals increased
5% to $31.8 million from $30.3 million in the prior period, primarily due to the launch of Vancomycin HCl for Oral Solution, Candesartan,
and other products launched in 2018 and 2019, as well as increased unit sales of Vancomycin tablets. These increases were tempered
by decreases in sales of Esterified Estrogen with Methlytestosterone ("EEMT"), Diphenoxylate Hydrochloride and Atropine
Sulfate, and Fenofibrate.
Key Generic Pipeline Product
In October 2019, ANI's collaborative partner Pharmaceutics
International Inc. received FDA approval of a Prior Approval Supplement for Bretylium Tosylate Injection, USP 500mg/10ml. ANI plans
to launch this currently unavailable drug in December 2019, introducing this critical drug for the treatment of ventricular fibrillation
and life-threatening ventricular arrhythmias, such as ventricular tachycardia.
Branded Pharmaceutical Products
Third Quarter Net Revenues - Results and Update
Net revenues from sales of branded pharmaceuticals increased
14% to $16.6 million from $14.6 million in the prior period, primarily due to increased sales of Atacand and Atacand HCT ,
which were launched under ANI's label in October 2018 and previously included as Royalty and other, and increases in sales
of Inderal LA, and Vancocin . These increases were tempered by a decrease in sales of Arimidex and Innopran XL .
Key Brand Pipeline Product
| Product | Required Filing | Filing Date | Total Annual Market (d) |
| Cortrophin Gel | sNDA | March 2020 | $1.1 billion |
(d) Based on data from IQVIA
Cortrophin Gel Re-commercialization Update
ANI continues to successfully progress our Cortrophin re-commercialization
program. Significant accomplishments since the second quarter 2019 press release (dated August 7, 2019) include:
ANI remains on track to file a supplemental NDA in the March
For further details, please see ANI's Cortrophin
Gel Re-commercialization Milestone Update in Table 5.
Contract Manufacturing
Third Quarter Net Revenues - Results and Update
Contract manufacturing revenues decreased 16% to $2.4 million
from $2.8 million in the prior year period, due to the timing and volume of orders from contract manufacturing customers in the
Third Quarter Net Revenues - Result and Update
Royalty and other decreased 80% to $0.6 million from $3.0 million,
primarily due to the launch Atacand and Atacand HCT under ANI's label in October 2018. The net sales from those
products are now included in the net sales of branded pharmaceutical products.
Key Royalty Product: Yescarta
ANI is entitled to a percentage of global Yescarta net
sales as well as a portion of certain product milestones, such as the recent positive opinion issued by the European Medicines
Agency ("EMA") Committee for Medicinal Products for Human Use ("CHMP").
Operating expenses increased to $44.0 million for the three
months ended September 30, 2019, from $40.6 million in the prior year period. The increase was primarily due to a $2.6 million
increase in selling, general, and administrative expense as compared with the prior period, as a result of costs related to the
ANI Canada subsidiary, increased U.S.-based headcount and pharmacovigilance compliance costs in continued support of the expansion
of our commercial portfolio, increased stock compensation expense, higher legal fees, and increased sales and marketing-related
costs. In addition, depreciation and amortization increased by $0.9 million, primarily due to additional amortization expense associated
with a March 2019 asset acquisition and a January 2019 royalty buyout payment related to a prior period asset acquisition. These
increases were partially offset by a $0.6 million decrease in cost of sales.
Cost of sales as a percentage of net revenues decreased to 29%
during the three months ended September 30, 2019, from 31% during same period in 2018. The decrease was primarily due to lower
royalty expense resulting from a royalty buy out and lower sales of products under profit-sharing arrangements.
Net Income and Diluted Earnings per Share
Net income was $3.9 million for the three months ended September
30, 2019, as compared to net income of $5.0 million in the prior year period. The effective consolidated tax rate excluding impacts
of discrete items for the three months ended September 30, 2019 was 8.4%.
Diluted earnings per share for the three months ended September
30, 2019 was $0.32, based on 12,085 thousand diluted shares outstanding, as compared to diluted earnings per share of $0.42 in
the prior year period. Adjusted non-GAAP diluted earnings per share was $1.23, as compared to adjusted non-GAAP diluted earnings
per share of $1.29 in the prior year period. For a reconciliation of adjusted non-GAAP diluted earnings per share to the most directly
comparable GAAP financial measure, please see Table 4.
ANI Product Development Pipeline
ANI's pipeline consists of 109 products, addressing a
total annual market size of $5.4 billion, based on data from IQVIA. Of these 109 products, 104 were acquired and of these acquired
products, ANI expects that at least 53 can be commercialized based on either CBE-30s or prior approval supplements filed with the