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Dienstag, 27.02.2018 14:31 von | Aufrufe: 84

ANI Pharmaceuticals Reports Record Full Year Results, Reports Fourth Quarter 2017 Results, and Provides 2018 Guidance

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PR Newswire

BAUDETTE, Minn., Feb. 27, 2018 /PRNewswire/ --  

 

For the full year ended December 31, 2017:

  • Record net revenues of $176.8 million, an increase of 37% versus 2016
  • GAAP net loss of $1.1 million, including a $13.4 million charge due to the Tax Cuts and Jobs Act
  • Diluted GAAP loss per share of $0.09, including $1.16 impact of charge due to the Tax Cuts and Jobs Act
  • Adjusted non-GAAP EBITDA of $74.2 million
  • Adjusted non-GAAP diluted earnings per share of $3.91

For the fourth quarter 2017:

  • Net revenues of $47.3 million, an increase of 24% as compared to the same period in 2016
  • GAAP net loss of $9.6 million, including impact of $13.4 million charge due to the Tax Cuts and Jobs Act
  • Diluted GAAP loss per share of $0.83, including $1.16 impact of charge due to the Tax Cuts and Jobs Act
  • Adjusted non-GAAP EBITDA of $19.7 million
  • Adjusted non-GAAP diluted earnings per share of $1.08

Guidance for 2018:

  • Net revenues of $212 million to $228 million
  • Adjusted non-GAAP EBITDA of $90 million to $100 million
  • Adjusted non-GAAP diluted earnings per share of $5.43 to $6.08

 

ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported its financial results for the three and twelve months ended December 31, 2017, and provided its 2018 financial guidance. The Company will host its earnings conference call this morning, February 27, 2018, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (866) 776-8875. The conference ID is 9773589.


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Financial Summary

(in thousands, except per share data)


Q4 2017


Q4 2016


2017


2016

Net revenues


$ 47,286


$ 38,205


$ 176,842


$ 128,622

Net (loss)/income


$  (9,629)


$  (1,080)


$    (1,076)


$     3,934

GAAP (loss)/earnings per diluted share


$    (0.83)


$    (0.09)


$      (0.09)


$       0.34

Adjusted non-GAAP EBITDA(a)


$ 19,672


$ 17,933


$    74,175


$   61,112

Adjusted non-GAAP diluted earnings per share(b)


$     1.08


$     0.90


$       3.91


$       2.96


(a) See Table 3 for U.S. GAAP reconciliation.

(b) See Table 4 for U.S. GAAP reconciliation.

Arthur S. Przybyl, President and CEO, stated,

"2017 was a record year for ANI, with revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share increasing 37%, 21%, and 32%, respectively, as compared to 2016. These increases are the result of the continued strength of our base business and six product launches in 2017, including four generic products and two brands, InnoPran XL® and Inderal® XL.

In December 2017, we continued to execute the strategic plan to grow our commercial portfolio by acquiring the NDAs and U.S. product rights for Atacand®, Atacand HCT®, Arimidex® and Casodex® – all products that can be manufactured at our containment facility in Baudette Minnesota. Since becoming a public company in 2013, ANI has deployed nearly $300M in product acquisitions to help build our current portfolio of commercial and pipeline products. We will continue to evaluate opportunities to expand the business throughout 2018.

Notably, we continue to work toward the development and subsequent commercialization of two branded pipeline products, Vancocin® oral solution and Cortrophin® gel.

Our Cortrophin® gel re-commercialization project continues to advance in line with internal timelines. Our team achieved important milestones in 2017, including the establishment of commercial relationships for our supply chain including raw material, API manufacture and finished dose manufacture. Successes in API manufacturing, analytical method development and process characterization allow ANI to advance manufacturing of commercial scale API and the registration batch in 2018.

Since going public in June 2013, we have focused on increasing our revenue and adjusted non-GAAP EBITDA through new product introductions, as evidenced in the table below showing our revenue and adjusted non-GAAP EBITDA growth from 2013 to our 2018 guidance, as well as the number of ANI's commercial products at the end of each year. The compound annual growth rates from 2013 to 2017 for net revenue and adjusted non-GAAP EBITDA are 56% and 77%, respectively." 

(in millions, except product data)


Net
Revenue


Adjusted non-
GAAP EBITDA(c)


Number of
Products


Actual Results:








2013


$   30


$    8


7


2014


$   56


$  27


10


2015


$   76


$  43


16


2016


$ 129


$  61


25


2017


$ 177


$  74


31


Mid-point of 2018 Guidance:







2018


$ 220


$  95











(c) See Tables 3 and 6 for U.S. GAAP reconciliation.

2018 Financial Guidance

For the twelve months ending December 31, 2018, ANI is providing guidance on net revenue, adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share. The following table summarizes 2018 guidance as compared to 2017 actual results:

(in millions, except per share data and percentages)


2017
Actual


2018 Guidance


% Increase
from Prior Year

Net revenues


$176.8


$212 to $228


20% to 29%

Adjusted non-GAAP EBITDA


$74.2


  $90 to $100


21% to 35%

Adjusted non-GAAP diluted earnings per share


$3.91


$5.43 to $6.08


39% to 55%

ANI's 2018 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. 2018 guidance includes:

  • revenues and expenses related to our December 29, 2017 acquisition of the NDAs and U.S. product rights for Atacand®, Atacand HCT®, Arimidex® and Casodex®;
  • continued growth in Research and Development spending driven by increased investment in our Cortrophin® Gel Re-Commercialization program. The above guidance ranges include approximately $14.0 million to $16.0 million of total ANI Research and Development expense as compared to $9.1 million incurred in 2017;
  • continued select investment in Selling, General, and Administrative expenses to support the continued growth of our business and brands;
  • a combined federal and state effective income tax rate of 23%; and
  • approximately 11.7 million shares of fully diluted common stock outstanding.

Effect of Tax Reform and Capital Allocation

The recently enacted Tax Cuts and Jobs Act will significantly enhance ANI's ability to invest in value generating opportunities and continue to leverage its wholly U.S. based manufacturing and research and development footprint.

  • Lower marginal tax rate: combined federal and state marginal tax rate will decrease from approximately 37% to 23%.
  • Improved cash flow: favorable impact of reduced cash tax burden in 2018 will approximate $10 to $13 million.
  • Strong capital position: ANI believes that this benefit, coupled with its existing cash balance of $31.1 million as of December 31, 2017, forecast cash flow from operating activities, and access to $50 million under its revolving credit facility will place it in a strong position to pursue business development activities in the coming year.
  • Continued internal investment: ANI plans to invest approximately $7 million in capital projects during 2018 in support of its operations and employees in Baudette, Minnesota. This is in addition to the $10.4 million invested during the course of 2017.

Cortrophin® Gel Re-commercialization Update

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