BAUDETTE, Minn., Nov. 6, 2019 /PRNewswire/ --
For the third quarter 2019:
- Net revenues of $51.3 million,
an increase of 1% versus prior year
- GAAP net income of $3.9
million and diluted GAAP earnings per share of $0.32
- Adjusted non-GAAP EBITDA of $19.8
million and adjusted non-GAAP diluted earnings per share of
$1.23
- ANI updates guidance for the full year 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.
Financial Summary
(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 generic franchises.
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:
- The completion of a fourth commercial scale batch of
Corticotropin API. This batch was analytically consistent with
previously manufactured batches and met all specifications. ANI has
completed manufacturing for three registration stability batches
and expects to complete API process validation in early fourth
quarter of 2019.
- The successful completion of viral clearance studies.
- The completion of a third commercial scale batch of Cortrophin®
Gel. This batch was analytically consistent with previously
manufactured batches and met all specifications. ANI has completed
manufacturing for three registration stability batches and expects
to complete drug product process validation in fourth quarter of
2019 using commercial scale API.
- Receipt of clinical data on Cortrophin® Gel (80 units/mL) from
a study that evaluated the blood-level cortisol response in a
20-person healthy volunteer population. The results indicate that
ANI's Cortrophin® Gel (80 units/mL) is effective for its intended
use. The data demonstrates that ANI's modernized drug product has a
cortisol response profile consistent with that observed in
historical scientific literature that evaluated the drug product
manufactured in the 1960s. No adverse safety events were reported
and minor events were as expected.
ANI remains on track to file a supplemental NDA in the March of
2020.
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
period.
Royalty and Other
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 of 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
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 FDA.
Non-GAAP Financial Measures
The Company's fiscal 2019 guidance for adjusted non-GAAP EBITDA
and adjusted non-GAAP diluted earnings per share is not reconciled
to the most comparable GAAP measure. This is due to the inherent
difficulty of forecasting the timing or amount of items that would
be included in a reconciliation to the most directly comparable
forward-looking GAAP financial measures. Because a reconciliation
is not available without unreasonable effort, it is not included in
this release.
Adjusted non-GAAP EBITDA
ANI's management considers adjusted non-GAAP EBITDA to be an
important financial indicator of ANI's operating performance,
providing investors and analysts with a useful measure of operating
results unaffected by non-cash stock-based compensation and
differences in capital structures, tax structures, capital
investment cycles, ages of related assets, and compensation
structures among otherwise comparable companies. Management uses
adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net income/(loss),
excluding tax expense, interest expense, depreciation,
amortization, the excess of fair value over cost of acquired
inventory, stock-based compensation expense, expense from acquired
in-process research and development, gains, losses, and expenses
related to the repurchase of convertible debt, expenses related to
debt financing, transaction and integration expenses, Cortrophin
pre-launch charges, other income / expense and certain other items
that vary in frequency and impact on ANI's results of operations.
Adjusted non-GAAP EBITDA should be considered in addition to,
but not in lieu of, net income or loss reported under GAAP. A
reconciliation of adjusted non-GAAP EBITDA to the most directly
comparable GAAP financial measure is provided in Table 3.
Adjusted non-GAAP Net Income
ANI's management considers adjusted non-GAAP net income to be an
important financial indicator of ANI's operating performance,
providing investors and analysts with a useful measure of operating
results unaffected by purchase accounting adjustments, non-cash
stock-based compensation, non-cash interest expense, depreciation
and amortization, and non-cash impairment charges. Management uses
adjusted non-GAAP net income when analyzing Company
performance.
Adjusted non-GAAP net income is defined as net income/(loss),
plus the excess of fair value over cost of acquired inventory,
stock-based compensation expense, transaction and integration
expenses, gains, losses, and expenses related to the repurchase of
convertible debt, expenses related to debt financing, non-cash
interest expense, depreciation and amortization expense, expense
from acquired in-process research and development, non-cash
impairment charges, Cortrophin pre-launch charges and certain other
items that vary in frequency and impact on ANI's results of
operations, less the tax impact of these adjustments calculated
using an estimated statutory tax rate. Management will continually
analyze this metric and may include additional adjustments in the
calculation in order to provide further understanding of ANI's
results. Adjusted non-GAAP net income should be considered in
addition to, but not in lieu of, net income reported under GAAP. A
reconciliation of adjusted non-GAAP net income to the most directly
comparable GAAP financial measure is provided in Table 4.
Adjusted non-GAAP Diluted Earnings per Share
ANI's management considers adjusted non-GAAP diluted earnings
per share to be an important financial indicator of ANI's operating
performance, providing investors and analysts with a useful measure
of operating results unaffected by purchase accounting adjustments,
non-cash stock-based compensation, non-cash interest expense,
depreciation and amortization, and non-cash impairment charges.
Management uses adjusted non-GAAP diluted earnings per share
when analyzing Company performance.
Adjusted non-GAAP diluted earnings per share is defined as
adjusted non-GAAP net income, as defined above, divided by the
diluted weighted average shares outstanding during the period, as
adjusted for the dilutive effect of the convertible debt notes,
when applicable. Management will continually analyze this metric
and may include additional adjustments in the calculation in order
to provide further understanding of ANI's results. Adjusted
non-GAAP diluted earnings per share should be considered in
addition to, but not in lieu of, diluted earnings or loss per share
reported under GAAP. A reconciliation of adjusted non-GAAP diluted
earnings per share to the most directly comparable GAAP financial
measure is provided in Table 4.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing high quality branded and generic
prescription pharmaceuticals. The Company's targeted areas of
product development currently include controlled substances,
oncolytics (anti-cancers), hormones and steroids, and complex
formulations involving extended release and combination products.
For more information, please visit the Company's website
www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with
information that is not historical, these are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements about price increases, the Company's future
operations, products, financial position, operating results and
prospects, the Company's pipeline or potential markets therefor,
and other statements that are not historical in nature,
particularly those that utilize terminology such as "anticipates,"
"will," "expects," "plans," "potential," "future," "believes,"
"intends," "continue," other words of similar meaning, derivations
of such words and the use of future dates.
Uncertainties and risks may cause the Company's actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risk that the Company may face with
respect to importing raw materials; increased competition;
acquisitions; contract manufacturing arrangements; delays or
failure in obtaining product approvals from the U.S. Food and Drug
Administration; general business and economic conditions; market
trends; regulatory environment; products development; regulatory
and other approvals; and marketing.
More detailed information on these and additional factors that
could affect the Company's actual results are described in the
Company's filings with the Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K and quarterly
reports on Form 10-Q, as well as its proxy statement. All
forward-looking statements in this news release speak only as of
the date of this news release and are based on the Company's
current beliefs, assumptions, and expectations. The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 1: US GAAP
Income Statement
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$51,337
|
|
$50,703
|
|
$158,581
|
|
$144,454
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Cost of sales (excl. depreciation and amortization)
|
|
|
|
|
|
|
|
|
|
15,002
|
|
15,605
|
|
45,359
|
|
52,891
|
Research and
development
|
|
4,982
|
|
4,667
|
|
15,128
|
|
11,906
|
Selling, general, and
administrative
|
|
14,357
|
|
11,769
|
|
41,829
|
|
30,687
|
Depreciation and
amortization
|
|
9,473
|
|
8,548
|
|
35,048
|
|
25,056
|
Cortrophin pre-launch
charges
|
|
195
|
|
-
|
|
195
|
|
-
|
|
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
|
44,009
|
|
40,589
|
|
137,559
|
|
120,540
|
|
|
|
|
|
|
|
|
|
Operating Income
|
|
7,328
|
|
10,114
|
|
21,022
|
|
23,914
|
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
(3,336)
|
|
(3,768)
|
|
(10,096)
|
|
(11,132)
|
Other
(expense)/income, net
|
|
(33)
|
|
20
|
|
(117)
|
|
(71)
|
|
|
|
|
|
|
|
|
|
Income Before
(Provision)/Benefit for Income Taxes
|
|
3,959
|
|
6,366
|
|
10,809
|
|
12,711
|
|
|
|
|
|
|
|
|
|
(Provision)/Benefit
for Income Taxes
|
|
(64)
|
|
(1,329)
|
|
120
|
|
(2,647)
|
|
|
|
|
|
|
|
|
|
Net Income
|
|
$
3,895
|
|
$
5,037
|
|
$
10,929
|
|
$
10,064
|
|
|
|
|
|
|
|
|
|
Earnings Per
Share
|
|
|
|
|
|
|
|
|
Basic Earnings Per
Share
|
|
$
0.32
|
|
$
0.43
|
|
$
0.91
|
|
$
0.85
|
Diluted Earnings Per
Share
|
|
$
0.32
|
|
$
0.42
|
|
$
0.89
|
|
$
0.85
|
|
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
11,879
|
|
11,706
|
|
11,826
|
|
11,659
|
Diluted
Weighted-Average Shares Outstanding
|
|
12,085
|
|
11,804
|
|
12,060
|
|
11,767
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 2: US GAAP
Balance Sheets
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2019
|
|
December 31,
2018
|
Current
Assets
|
|
|
|
|
Cash and cash equivalents
|
|
$
59,673
|
|
$
43,008
|
Accounts receivable, net
|
|
70,700
|
|
64,842
|
Inventories, net
|
|
46,174
|
|
40,503
|
Prepaid income taxes, net
|
|
814
|
|
-
|
Prepaid expenses and other current assets
|
|
5,025
|
|
4,524
|
|
|
|
|
|
Total
Current Assets
|
|
182,386
|
|
152,877
|
|
|
|
|
|
Property and
equipment, net
|
|
39,754
|
|
38,090
|
Restricted
cash
|
|
5,025
|
|
5,021
|
Deferred tax assets,
net of deferred tax liabilities and valuation allowance
|
|
36,002
|
|
27,964
|
Intangible assets,
net
|
|
188,372
|
|
201,604
|
Goodwill
|
|
3,580
|
|
3,580
|
Other non-current
assets
|
|
1,656
|
|
1,468
|
|
|
|
|
|
Total
Assets
|
|
$
456,775
|
|
$
430,604
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
Current component of Term Loan, net of deferred financing
costs
|
|
$
4,154
|
|
$
3,256
|
Convertible notes, net of discount and deferred financing
costs
|
|
117,586
|
|
112,463
|
Accounts
payable
|
|
10,953
|
|
8,884
|
Accrued expenses and other
|
|
3,368
|
|
1,707
|
Accrued royalties
|
|
5,527
|
|
8,456
|
Accrued compensation and related expenses
|
|
3,494
|
|
3,524
|
Current income taxes payable, net
|
|
-
|
|
5,022
|
Accrued government rebates
|
|
9,184
|
|
8,974
|
Returned goods reserve
|
|
15,945
|
|
12,552
|
Deferred revenue
|
|
496
|
|
711
|
|
|
|
|
|
Total
Current Liabilities
|
|
170,707
|
|
165,549
|
|
|
|
|
|
Term Loan, net of deferred financing costs and current
component
|
|
64,873
|
|
67,296
|
Other non-current liabilities
|
|
8,065
|
|
496
|
|
|
|
|
|
Total
Liabilities
|
|
243,645
|
|
233,341
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
Common
stock
|
|
1
|
|
1
|
Treasury
stock
|
|
(723)
|
|
(659)
|
Additional paid-in
capital
|
|
197,470
|
|
186,812
|
Retained
earnings
|
|
22,419
|
|
11,488
|
Accumulated other
comprehensive loss, net of tax
|
|
(6,037)
|
|
(379)
|
|
|
|
|
|
Total
Stockholders' Equity
|
|
213,130
|
|
197,263
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity
|
|
$
456,775
|
|
$
430,604
|
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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$
3,895
|
|
$
5,037
|
|
$10,929
|
|
$10,064
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
3,336
|
|
3,768
|
|
10,096
|
|
11,132
|
Other
expense/(income), net
|
|
33
|
|
(20)
|
|
117
|
|
71
|
(Provision)/Benefit for income taxes
|
|
64
|
|
1,329
|
|
(120)
|
|
2,647
|
Depreciation and amortization
|
|
9,473
|
|
8,548
|
|
35,048
|
|
25,056
|
Cortrophin pre-launch charges
|
|
195
|
|
-
|
|
195
|
|
-
|
Expensed
FDA approval milestone payment
|
|
329
|
|
-
|
|
329
|
|
-
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
2,470
|
|
1,795
|
|
6,773
|
|
4,954
|
Acquired
IPR&D expense
|
|
-
|
|
-
|
|
2,324
|
|
1,335
|
Excess
of fair value over cost of acquired inventory
|
|
-
|
|
44
|
|
-
|
|
5,689
|
Transaction and integration expenses
|
|
-
|
|
928
|
|
84
|
|
1,269
|
Adjusted non-GAAP EBITDA
|
|
$
19,795
|
|
$21,429
|
|
$65,775
|
|
$62,217
|
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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$
3,895
|
|
$
5,037
|
|
$10,929
|
|
$10,064
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Non-cash interest expense
|
|
1,871
|
|
1,980
|
|
5,525
|
|
5,839
|
Depreciation and amortization expense
|
|
9,473
|
|
8,548
|
|
35,048
|
|
25,056
|
Cortrophin pre-launch charges
|
|
195
|
|
-
|
|
195
|
|
-
|
Expensed FDA approval milestone payment
|
|
329
|
|
-
|
|
329
|
|
-
|
Acquired IPR&D expense
|
|
-
|
|
-
|
|
2,324
|
|
1,335
|
Stock-based compensation
|
|
2,470
|
|
1,795
|
|
6,773
|
|
4,954
|
Excess of fair value over cost of acquired inventory
|
|
-
|
|
44
|
|
-
|
|
5,689
|
Transaction and integration expenses
|
|
-
|
|
928
|
|
84
|
|
1,269
|
Less
|
|
|
|
|
|
|
|
|
Tax
impact of add back items
|
|
(3,441)
|
|
(3,058)
|
|
(12,067)
|
|
(10,153)
|
Discrete tax
benefit related to ANI Canada transfer pricing agreement
|
|
-
|
|
-
|
|
(1,653)
|
|
-
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
|
$14,792
|
|
$15,274
|
|
$47,487
|
|
$44,053
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
|
|
|
|
Shares
Outstanding
|
|
12,085
|
|
11,804
|
|
12,060
|
|
11,767
|
Less dilutive effect
of notes
|
|
(78)
|
|
-
|
|
(128)
|
|
-
|
Adjusted Diluted
Weighted-Average
|
|
|
|
|
|
|
|
|
Shares
Outstanding
|
|
12,007
|
|
11,804
|
|
11,932
|
|
11,767
|
|
|
|
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
|
|
|
|
Diluted Earnings per Share
|
|
$
1.23
|
|
$
1.29
|
|
$
3.98
|
|
$
3.74
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 5:
Cortrophin® Gel Re-Commercialization Milestone
Update
|
|
|
|
|
|
|
|
|
Objective
|
Duration
|
Steps /
Details
|
Status
|
Manufacture
commercial-scale
batches of corticotropin API
|
2-3 months
per batch
|
• Scale-up
manufacturing process 5x to projected commercial scale
|
Complete
|
• Finalize API
manufacturing process & initiate PV / registration
batches
|
Complete
|
• Method development
for API characterization methods
|
Complete
|
• Method validation
for API release / stability methods
|
Complete
|
• Perform viral
clearance studies and validation
|
Complete
|
Manufacture
Commercial Scale
Cortrophin® Gel Drug Product
|
1 month per
batch
|
|
|
•
Finalize drug product manufacturing process
|
Complete
|
• Initiate process
validation
|
Complete
|
• Method validation
for API release / stability methods
|
Complete
|
• Manufacture three
API and three drug product registration batches
|
Complete
|
|
|
|
|
Registration
stability for sNDA
|
6 months
|
• Initiate
registration stability studies
|
Complete
|
• Demonstrate 6
months accelerated and real-time stability prior to sNDA
submission
|
On Track
|
sNDA
submission
|
|
• Target date: March
2020
|
On Track
|
|
• Filing - four month
PDUFA date
|
|
View original
content:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-third-quarter-results-300952305.html
SOURCE ANI Pharmaceuticals, Inc.