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ANI Pharmaceuticals Reports First Quarter Results and Year-To-Date 2016 Highlights and Reaffirms Updated Guidance

BAUDETTE, Minn., May 5, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") ANIP, -4.71% today reported financial results for the three months ended March 31, 2016, and reaffirmed its financial guidance for 2016 as updated on April 4, 2016. The Company will host its earnings conference call this morning, May 5, 2016, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (844) 295-8236. The conference ID is 93601942.

Arthur S. Przybyl, President and CEO, stated,

"ANI had a strong first quarter. Thus far in 2016, we have closed three acquisitions and received two FDA approvals. We anticipate launching a total of seven products in the second quarter of 2016, three of which were launched in April.

We began the year with the completion of our acquisition of the Corticotropin NDAs on January 4 [th] , followed closely by the January 28 [th] acquisition of the exclusive rights to distribute the authorized generic of Lipofen®, as well as 1% and 2.5% hydrocortisone rectal cream. We launched the hydrocortisone rectal cream products in April and are currently launching the authorized generic of Lipofen® in our own label. On April 1 [st] , we completed our acquisition of the Inderal® NDA, which will be accretive to revenue and adjusted non-GAAP EBITDA starting in the second quarter and is included in our guidance."

ANI's Updated Guidance for the Full Year 2016

ANI's estimates are based on projected results for the twelve months ending December 31, 2016 and reflect management's current beliefs about product pricing, prescription trends, inventory levels, cost of sales, operating costs, and the anticipated timing of future product launches and events.

  • Net revenues for 2016 to be between $119million and $134million.
  • Adjusted non-GAAP EBITDA [(a)] , to be between $55 million and $63million.
  • Adjusted non-GAAP net income per diluted share [(b)] , to be between $3.54 and $3.91, assuming 11,489 thousand weighted average shares outstanding.
  • Reported (US GAAP) diluted EPS to be between $0.30 and $0.65.

ANI's 2016 guidance is based on certain assumptions including:

  • EEMT market share is anticipated to remain stable at approximately 50%.
  • Cost of sales [(c)] of approximately 35%.
  • Operating expenses [(d)] , inclusive of research and development costs, of between $24 and $24.5 million.
  • Depreciation and amortization expense of approximately $22.6 million.
  • Interest expense of approximately $11.4 million.
  • Current tax provision of between $11.5 and $16.5 million.

[(a)] See Table 2 for US GAAP reconciliation. [(b)] See Table 3 for US GAAP reconciliation. [(c)] Exclusive of depreciation and amortization. [(d)] Excludes non-cash stock compensation expense.

New Product Introductions

Product


Total Annual Market Size(e)


Estimated Launch


FDA ApprovalsRequired

Inderal® LA


$23M


Launched April 2016


Approved

Propranolol ER


$165M


Launched April 2016


Approved

Hydrocortisone rectal cream, 1% and 2.5%


$84M


Launched April 2016


Approved

Fenofibrate 50mg and 150mg


$24M


May 2016


Approved

Authorized generic product


$21M


May 2016


Approved

Oxycodone capsules


$7.5M


June 2016


Approved

Anti-cancer drug


Undisclosed


June 2016


ANDA

Donepezil


$41M


Q3 2016


Approved

Anti-Infective


$75M


Q3 2016


CBE-30

Three IDT products


$86M


Q3 2016/Q4 2016


CBE-30s

Three additional C-II products (TADs(f) 1/2/2017 and 2/15/2017)


$39M


Q1 2017


ANDAs

[ (e)] Per IMS Health [(f)] FDA's Target Action Date, per FDA communications

Year-to-Date Highlights Include:

  • First quarter net revenues of $20.6 million, an increase of 9% as compared to $18.8 million for the same period in 2015.
  • First quarter adjusted non-GAAP EBITDA of $11.4 million, a slight decrease of 1% as compared to $11.5 million for the same period in 2015.
  • First quarter operating income of $5.7 million, a decrease of 41% as compared to $9.6 million for the same period in 2015.
  • First quarter adjusted non-GAAP diluted earnings per share of $0.76.
  • First quarter diluted earnings per share of $0.12.
  • Appointment of Stephen P. Carey as Vice President and Chief Financial Officer.
  • Acquired NDAs for Corticotropin and Corticotropin-Zinc.
  • Acquired exclusive rights to distribute an authorized generic of Lipofen® and 1% and 2.5% hydrocortisone rectal cream.
  • Acquired the product rights for Inderal® LA.
  • Received ANDA approval for Donepezil tablets (via Dexcel partnership).
  • Received ANDA approval for Oxycodone capsules.
  • Launched 1% and 2.5% hydrocortisone rectal cream.
  • Launched Inderal® LA and Propranolol ER.
  • Repurchased 65 thousand shares of ANIP common stock for $2.5 million.

First Quarter Results


Net Revenues

(in thousands)


Three Months Ended March 31,








2016


2015


Change


% Change

Generic pharmaceutical products


$

13,252


$

12,256


$

996


8%

Branded pharmaceutical products



5,596



4,272



1,324


31%

Contract manufacturing



1,384



1,205



179


15%

Contract services and other income



323



1,066



(743)


(70)%

Total net revenues


$

20,555


$

18,799


$

1,756


9%

For the three months ended March 31, 2016, ANI reported net revenues of $20.6million, an increase of 9% from $18.8 million in the prior year period, due to the following factors:

  • Revenues from sales of generic pharmaceuticals increased 8%, to $13.3 million from $12.3 million in the prior period, primarily due to, sales of Oxycodone oral solution, Vancomycin, Nimodipine, and Flecainide, all of which were launched in Q4 2015, as well as full quarter sales of Etodolac, and Propafenone, which launched in Q1 2015.
  • Revenues from sales of branded pharmaceuticals increased...

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