ANI Pharmaceuticals (ANIP)

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News for 'ANIP' - (Press Release: ANI Pharmaceuticals Reports Record -3-)

Provision for Income
Taxes (1,269) (1,227) (1,792) (2,767)

Net Income $ 2,681 $ 1,125 $ 3,833 $ 2,471

Earnings Per Share
Basic Earnings Per
Share $ 0.23 $ 0.10 $ 0.33 $ 0.22
Diluted Earnings Per
Share $ 0.23 $ 0.10 $ 0.33 $ 0.21

Basic
Weighted-Average
Shares Outstanding 11,546 11,402 11,536 11,398
Diluted
Weighted-Average
Shares Outstanding 11,667 11,541 11,659 11,514


ANI Pharmaceuticals, Inc. and Subsidiaries
Table 2: US GAAP Balance Sheets
(unaudited, in thousands)


June 30, December 31,
2017 2016
Current Assets
Cash and cash equivalents $ 8,369 $ 27,365
Accounts receivable, net 55,513 45,895
Inventories, net 42,307 26,183
Prepaid income taxes 3,991 -
Prepaid expenses and other current assets 2,676 3,564

Total Current Assets 112,856 103,007

Property and equipment, net 14,966 10,998
Restricted cash 5,002 5,002
Deferred tax asset, net of valuation allowance 27,933 26,227
Intangible assets, net 196,624 175,792
Goodwill 1,838 1,838

Total Assets $359,219 $ 322,864

Current Liabilities
Accounts payable $ 3,153 $ 3,389
Accrued expenses and other 1,565 927
Accrued royalties 11,255 11,956
Accrued compensation and related expenses 1,227 1,631
Current income taxes payable - 2,398
Accrued government rebates 3,534 5,891
Returned goods reserve 7,558 5,756

Total Current Liabilities 28,292 31,948

Long-term royalties - 625
Borrowings on line of credit 30,000 -
Convertible notes, net of discount and
deferred financing costs 124,381 120,643

Total Liabilities 182,673 153,216

Stockholders' Equity
Common stock 1 1
Treasury stock (259) -
Additional paid-in capital 175,901 172,563
Retained earnings/(Accumulated deficit) 903 (2,916)

Total Stockholders' Equity 176,546 169,648

Total Liabilities and Stockholders' Equity $359,219 $ 322,864


ANI Pharmaceuticals, Inc. and Subsidiaries
Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP
Reconciliation
(unaudited, in thousands)


Three Months Ended June
30, Six Months Ended June 30,
2017 2016 2017 2016

Net Income $ 2,681 $ 1,125 $ 3,833 $ 2,471

Add back
Interest
expense, net 3,025 2,830 5,957 5,612
Other expense,
net 19 12 37 10
Provision for
income taxes 1,269 1,227 1,792 2,767
Depreciation and
amortization 7,101 5,956 13,807 10,565

Add back
Stock-based
compensation 1,807 2,217 3,193 3,322
Excess of fair
value over cost
of acquired
inventory 3,210 2,078 4,745 2,078
Expenses related
to transaction
not
consummated - - 477 -
Adjusted
non-GAAP
EBITDA $19,112 $15,445 $33,841 $26,825


ANI Pharmaceuticals, Inc. and Subsidiaries
Table 4: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted
Earnings per Share Reconciliation
(unaudited, in thousands, except per share amounts)

Three Months Ended June
30, Six Months Ended June 30,
2017 2016 2017 2016

Net Income $ 2,681 $1,125 $ 3,833 $ 2,471

Add back
Non-cash
interest
expense 1,774 1,757 3,566 3,482
Depreciation
and
amortization
expense 7,101 5,956 13,807 10,565
Stock-based
compensation 1,807 2,217 3,193 3,322
Excess of fair
value over
cost of
acquired
inventory 3,210 2,078 4,745 2,078
Expenses
related to
transaction
not
consummated - - 477 -
Less
Tax impact of
adjustments (5,140) (4,443) (9,542) (7,195)

Adjusted non-GAAP
Net Income $11,433 $8,690 $20,079 $14,723

Diluted
Weighted-Average
Shares
Outstanding 11,667 11,541 11,659 11,514

Adjusted non-GAAP
Diluted
Earnings per
Share $ 0.98 $ 0.75 $ 1.72 $ 1.28


ANI Pharmaceuticals, Inc. and Subsidiaries
Table 5: Corticotropin Re-Commercialization Milestone Update


Step Duration Status Additional Details
Manufacture 4 mos. Complete -- Initial batch
small-scale batch of yields similar to
corticotropin API historical yields
-- Analytical method
development and
testing ongoing
-- Initiate stability
testing
Select drug product 6 mos. Ongoing -- Drug product CMO
CMO has been identified
Manufacture 2-3 mos. per batch Ongoing -- Demonstrate lot to
intermediate-scale lot consistency
batches of
corticotropin API
-- Further
refine/modernize
analytical methods
and process
-- Establish API
specifications
Type C meeting with Target 2H2017 -- Present
FDA re-commercialization
plan
-- Preliminary batch
characterization and
comparability data
-- Updated analytical
methods
Manufacture demo TBD Target 2H2017 -- Initiate
batches of formulation / fill /
Cortrophin Gel finish of drug
product
Manufacture 2-3 mos. per batch Not started -- Process validation
commercial-scale
batches of
corticotropin API
-- Registration /
Commercial batches
-- Initiate
registration-enabling
ICH stability
studies
Manufacture TBD Not started -- Process validation
registration batches
of Cortrophin Gel
-- Registration /
Commercial batches
-- Initiate
registration-enabling
ICH stability
studies
Initiate 6 mos. Not started -- Six months of
registration accelerated stability
stability for sNDA from drug substance
and drug product
batches at time of
submission
sNDA submission TBD TBD -- PAS filing - four
month PDUFA date

View original content:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-record-second-quarter-and-year-to-date-2017-results-and-reaffirms-guidance-300498387.html
SOURCE ANI Pharmaceuticals, Inc.
/Web site: www.anipharmaceuticals.co