BAUDETTE, Minn., Nov. 3, 2015 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported financial results for the three and nine months ended September 30, 2015 and updated its financial guidance for 2015. The Company will host its earnings conference call this morning, November 3, 2015, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (844) 295-8236. The conference ID is 59208657.
Arthur S. Przybyl, President and CEO, stated,
"We are pleased to report a strong third quarter, with increases over the prior year in revenue, EBITDA, and operating income. We have a compelling product pipeline of 85 drugs that represent over $4.6 billion in IMS sales. Recently, we launched two new generic drugs, Oxycodone and Vancomycin, which will help to expand our growing generic business segment and increased our total currently-marketed products to 14. Our near-term focus is on launching ten additional drugs over the next five quarters. Two of these drugs represent the potential for significant upside to our revenues and EBITDA. Business development activities included a new agreement with IDT Australia to commercialize 18 previously approved drugs and our announcement to acquire two Corticotropin NDAs from Merck. These NDAs have the future potential to be the largest selling drugs in ANI's portfolio."
Net revenues and Adjusted Non-GAAP EBITDA | |||||||
(in thousands) | Three months ended | Nine months ended | |||||
2015 | 2014 | 2015 | 2014 | ||||
Net revenues | $ 19,972 | $ 17,387 | $ 58,287 | $ 34,933 | |||
Adjusted Non-GAAP EBITDA(a) | $ 11,618 | $ 10,078 | $ 33,938 | $ 14,549 | |||
(a) | See Table 2 for US GAAP reconciliation. |
Year-to-Date Highlights Include:
- Year-to-date net revenues of $58.3 million, an increase of 67% as compared to $34.9 million for the same period in 2014.
- Year-to-date adjusted non-GAAP EBITDA of $33.9 million, an increase of 133% as compared to $14.5 million for the same period in 2014.
- Year-to-date operating income of $26.4 million, an increase of 186% as compared to $9.2 million for the same period in 2014.
- Year-to-date adjusted non-GAAP net income per diluted share of $2.20.
- Year-to-date diluted earnings per share of $1.07.
- Awarded two new contracts for EEMT, which were effective in the 2nd and 3rd quarters.
- Launched Oxycodone Hydrochloride oral solution.
- Launched Vancomycin capsules.
- Launched Etodolac capsules and Propafenone tablets.
- Received ANDA approval for Nimodipine capsules (via Sofgen partnership).
- Entered into an agreement to acquire 2 NDAs for purified Corticotropin gel and Corticotropin-zinc Hydroxide for $75 million.
- Entered into a collaborative arrangement with IDT Australia to commercialize up to 18 drugs related to previously-approved ANDAs.
- Acquired 22 generic products for $25.0 million.
- Acquired Flecainide ANDA for $4.5 million.
- Acquired 1% Testosterone Gel NDA.
Third Quarter Results | |||||||||||||
Net Revenues (in thousands) | Three Months Ended | ||||||||||||
2015 | 2014 | Change | % Change | ||||||||||
Generic pharmaceutical products | $ | 15,102 | $ | 10,188 | $ | 4,914 | 48 % | ||||||
Branded pharmaceutical products | 2,253 | 4,806 | (2,553) | (53)% | |||||||||
Contract manufacturing | 1,280 | 1,350 | (70) | (5)% | |||||||||
Contract services and other income | 1,337 | 1,043 | 294 | 28 % | |||||||||
Total net revenues | $ | 19,972 | $ | 17,387 | $ | 2,585 | 15 % | ||||||
For the three months ended September 30, 2015, ANI reported net revenues of $20.0 million, an increase of 15% from $17.4 million in the prior year period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 48%, to $15.1 million from $10.2 million in the prior period, primarily due to increased sales of EEMT, as well as sales from Methazolamide, which was launched in the fourth quarter of 2014, and Etodolac and Propafenone, which were launched in the first quarter of 2015.
- Revenues from sales of branded pharmaceuticals decreased 53%, to $2.3 million from $4.8 million in the prior period, primarily as a result of lower unit sales of Reglan, decreases in unit sales of Lithobid and Vancocin, and increased Medicaid utilization and Medicaid rebates for both Lithobid and Vancocin.
- Contract manufacturing revenue decreased by 5% to $1.3 million from $1.4 million in the prior year period, primarily as a result of timing of customer orders.
- Contract services and other revenues increased by 28%, to $1.3 million from $1.0 million, primarily due to royalties received on sales of the authorized generic of Vancocin. In November, the Company launched an authorized generic for Vancocin under its own label, which replaced the authorized generic product previously on the market.
Adjusted non-GAAP EBITDA was $11.6 million for the three months ended September 30, 2015, compared to $10.1 million in the prior year period, an increase of 15%. For a reconciliation of adjusted non-GAAP EBITDA to GAAP operating income, please see Table 2.
Cost of sales decreased as a percentage of net revenues to 16% from 18%, primarily due to a favorable shift in product mix toward the Company's higher-margin products and margin increases for the Company's generic products.
Research and development costs decreased to $0.8 million for the three months ended September 30, 2015, from $0.9 million in the prior year period. The decrease was due to timing of work on development projects. Major development projects include the ANDAs acquired in 2014 and 2015, Flecainide, and collaborations with partners.
Selling, general and administrative expenses increased to $5.4 million for the three months ended September 30, 2015, from $4.1 million in the prior year period. The increase was primarily due to increased business development activities and increased personnel and compensation costs.
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