BAUDETTE, Minn., May 7, 2020 /PRNewswire/ --
For the first quarter 2020, ANI reports:
- Net revenues of $49.8 million
versus $52.9 million in 2019
- GAAP net loss of $7.0 million
and diluted GAAP loss per share of $0.59
- Adjusted non-GAAP EBITDA of $17.6
million
- Adjusted non-GAAP diluted earnings per share of $1.04
Integrates Amerigen Pharmaceuticals, Ltd. portfolio
Launches five generic products increasing total
commercialized product line to 60 product families
Appoints Patrick D. Walsh
interim President and CEO
Suspends guidance for 2020
ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today
reported its financial results for the three months ended
March 31, 2020. The Company will host
its earnings conference call this morning, May 7, 2020, at 10:30 AM
ET. Investors and other interested parties can join the call
by dialing (866) 776-8875. The conference ID is 5243607.
Financial Summary
(in thousands,
except per share data)
|
|
Q1
2020
|
|
Q1
2019
|
Net
revenues
|
|
$ 49,774
|
|
$ 52,887
|
Net
(loss)/income
|
|
$ (7,011)
|
|
$
449
|
GAAP
(loss)/earnings per diluted share
|
|
$
(0.59)
|
|
$
0.04
|
Adjusted non-GAAP
EBITDA(a)
|
|
$ 17,554
|
|
$ 22,299
|
Adjusted non-GAAP
diluted earnings per share(b)
|
|
$
1.04
|
|
$
1.30
|
|
(a) See Table 3 for US GAAP
reconciliation.
|
(b) See Table 4 for US GAAP
reconciliation.
|
Arthur S. Przybyl, President and
CEO, stated,
"ANI generated net revenues and non-GAAP earnings that met
management's expectations during a period that was marked by
significant uncertainties due to the COVID-19 pandemic. Our
performance during this period is a testament to the commitment of
our employees and to the strength of the business that we have
built. I am proud of the accomplishments that were made
during my eleven-year tenure as CEO of ANI. During this time,
we have built ANI from a small private company to a thriving public
specialty pharmaceutical business with an increasing diverse
commercial product offering and an incredibly valuable pipeline
opportunity in Cortrophin® Gel. As I depart ANI, I am
confident that I leave the business in good health, in the hands of
a very strong management team, and with its best days ahead of
it. I welcome Patrick Walsh
from the Board of Directors to the role of interim CEO and trust in
his ability to lead the Company until such time as my replacement
is identified."
Appoints Interim CEO
As previously announced, Mr. Przybyl will depart as President
and CEO on May 10, 2020. The
Board of Directors of ANI (BOD) has
appointed Patrick D. Walsh interim
President and CEO, effective May 11,
2020, until such time that Mr. Przybyl's permanent
replacement is hired. Mr. Walsh has served on the ANI BOD
since 2018 and has extensive pharmaceutical industry
experience. For Mr. Walsh's complete bio, please refer to
ANI's proxy statement filed on April
23, 2020. The BOD has retained nationally recognized
executive search firm Heidrick & Struggles and is currently
conducting the search for a President and CEO.
Continues Expansion of Commercialized Product
Portfolio
During the first quarter of 2020, we successfully integrated the
Amerigen Pharmaceuticals, Ltd. U.S. product portfolio, which was
purchased in January for $52.5
million. This transaction increased our commercialized
generic product portfolio by nine products from 35 to 44 and
increased our pipeline portfolio by an additional thirteen
opportunities. In addition, we launched five generic products
during the quarter, further expanding our generic offerings to 49,
and our total commercialized offerings including brands to 60.
First Quarter Results
Net
Revenues
(in
thousands)
|
|
Three Months
Ended
March 31,
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
37,495
|
|
$
|
31,599
|
|
$
|
5,896
|
|
19%
|
Branded
pharmaceutical products
|
|
|
9,157
|
|
|
17,543
|
|
|
(8,386)
|
|
(48)%
|
Contract
manufacturing
|
|
|
1,974
|
|
|
2,437
|
|
|
(463)
|
|
(19)%
|
Royalty and other
income
|
|
|
1,148
|
|
|
1,308
|
|
|
(160)
|
|
(12)%
|
Total net
revenues
|
|
$
|
49,774
|
|
$
|
52,887
|
|
$
|
(3,113)
|
|
(6)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic Pharmaceutical Products
Net revenues for generic pharmaceutical products were
$37.5 million during the three
months ended March 31, 2020, an
increase of 19% compared to $31.6 million for the same period in 2019.
The primary drivers of the increase are the September 2019 launch of Vancomycin Oral Solution
and the January 2020 launch of
Miglustat, Mixed Amphetamine Salts, Penicillamine and Paliperidone,
all products acquired in January from Amerigen Pharmaceuticals,
Ltd. ("Amerigen"). These increases were tempered by decreases in
sales of Vancomycin capsules, Esterified Estrogen with
Methyltestosterone ("EEMT"), Erythromycin Ethylsuccinate ("EES"),
and Ezetimibe Simvastatin.
Branded Pharmaceutical Products
Net revenues for branded pharmaceutical products were
$9.2 million during the three months
ended March 31, 2020, a decrease of
48% compared to $17.5 million for the
same period in 2019. The primary reasons for the decrease were
lower unit sales of Inderal XL, Inderal LA and Atacand as well as
decreased sales of Arimidex.
Contract Manufacturing
Contract manufacturing revenues were $2.0 million during the three months ended
March 31, 2020, a decrease of 19%
compared to $2.4 million for the same
period in 2019, due to the timing and volume of orders from
contract manufacturing customers in the period.
Royalty and Other
Royalty and other were $1.1
million during the three months ended March 31, 2020, a decrease of $0.2 million from $1.3
million for the same period in 2019, primarily due to a
decrease in royalty and laboratory service revenues, tempered by
increases in product development revenues earned by ANI Canada
during the three months ended March 31,
2020.
Operating Expenses
Operating expenses increased to $57.6
million for the three months ended March 31, 2020, from $48.5
million in the prior year period. The increase was primarily
due to the following:
- $7.1
million increase in cost of sales, primarily as a result of
$2.7 million in cost of sales
representing the excess of fair value over cost for inventory
acquired in the Amerigen acquisition and subsequently sold during
the period, increased volumes related to a shift in product mix
towards generic products, current period inventory reserve charges
and increased sales of products subject to profit-sharing
arrangements,
- $4.6
million in the build of Cortrophin® pre-launch commercial
inventories (which are expensed for US GAAP); there were no such
comparable activities in the first quarter 2019, and
- $2.0
million increase in research and development expense,
primarily due to $3.8 million
in-process research and development expense from the Amerigen
acquisition, partially offset by a decrease in expense related to
the Cortrophin® re-commercialization project as we begin to
complete our development efforts.
These increases were tempered by a $4.9
million decrease in depreciation and amortization expense,
primarily due to the non-reoccurrence of amortization expense
recorded in relation to the January
2019 royalty buy out, partially offset by the amortization
of the Abbreviated New Drug Applications and marketing and
distribution rights acquired in January
2020 from Amerigen.
Cost of sales exclusive of the $2.7
million net impact related to the excess of fair value over
the cost of inventory sold during the period as a percentage of net
revenues increased to 38% during the three months ended
March 31, 2020, from 28% during same
period in 2019, primarily as a result of a shift in product mix to
an increased volume of generic products, which have lower average
selling prices, inventory reserve charges in the current quarter as
well as increased sales of products subject to profit-sharing
arrangements during the current quarter.
Net Loss and Diluted Loss per Share
Net loss was $7.0 million for the
three months ended March 31, 2020, as
compared to net income of $0.4
million in the prior year period. The effective consolidated
tax benefit rate for the three months ended March 31, 2020 was 29.7%.
Diluted loss per share for the three months ended March 31, 2020 was $0.59, based on 11,902 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.04 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $1.04, as compared to adjusted non-GAAP
diluted earnings per share of $1.30
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.
Cortrophin® Gel Re-commercialization Update
Product
|
Required
Filing
|
Total Annual
Market(c)
|
Cortrophin®
Gel
|
sNDA
|
$950
million
|
|
(c) Based on data from
IQVIA
|
ANI filed the sNDA for Cortrophin® Gel
re-commercialization on March 23,
2020, on track with our long-standing publicly projected Q1
2020 target filing date. The FDA initially set a PDUFA goal date of
July 23, 2020, however as announced
on April 29, 2020, subsequently
issued a Refusal to File (RTF) letter. ANI will request a
Type-A meeting with the FDA in order to discuss the deficiencies
identified in the RTF letter and our plan to address each of
them. In addition, significant accomplishments since the
fourth quarter 2020 press release (dated February 27, 2020) include:
- ANI successfully completed manufacturing for a sixth commercial
scale batch of Corticotropin API. All six commercial scale batches
have been analytically consistent with each other and have met all
API release specifications.
- ANI obtained 6 months accelerated and real-time stability on
all API registration batches which facilitated sNDA filing by the
end of first quarter 2020.
- ANI successfully completed three media fill simulations
demonstrating sterility assurance for our Cortrophin®
Gel manufacturing process.
- ANI obtained 6 months accelerated and real-time stability on
all drug product registration batches which also facilitated sNDA
filing by the end of first quarter 2020.
- ANI successfully completed full shipping validation which
confirmed that the integrity of Cortrophin® Gel is fully
maintained to support our commercial launch and distribution
plan.
- In preparation for a future launch, ANI has continued to
stockpile porcine pituitaries and corticotropin API to ensure that
it can satisfy market demand.
For further details, please see ANI's Cortrophin® Gel
Re-commercialization Milestone Update in Table 5.
ANI Guidance for the Full Year 2020
Due to inherent uncertainties regarding the duration and impact
of the coronavirus (COVID-19) pandemic, ANI is suspending its
previously announced 2020 financial guidance.
ANI Product Development Pipeline
ANI's pipeline consists of 116 products, addressing a total
annual market size of $5.8 billion,
based on data from IQVIA. Of these, ANI expects that at least 52
can be commercialized based on either CBE-30s or prior approval
supplements filed with the FDA.
Non-GAAP Financial Measures
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, excluding tax
expense or benefit, 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 on inventory reserve recoveries,
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 the excess of fair value over cost of
acquired inventory sold, non-cash stock-based compensation,
non-cash interest expense, depreciation and amortization, inventory
reserve recoveries, Cortrophin pre-launch charges, acquired
IPR&D expense, transaction and integration expenses and certain
other items that vary in frequency and impact on ANI's results of
operations. Management uses adjusted non-GAAP net income when
analyzing Company performance.
Adjusted non-GAAP net income is defined as net income, plus the
excess of fair value over cost of acquired inventory sold,
stock-based compensation expense, transaction and integration
expenses, non-cash interest expense, depreciation and amortization
expense, expense from acquired in-process research and development,
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 the excess of fair value over
cost of acquired inventory sold, non-cash stock-based compensation,
non-cash interest expense, depreciation and amortization, inventory
reserve recoveries, Cortrophin pre-launch charges, acquired
IPR&D expense, transaction and integration expenses and certain
other items that vary in frequency and impact on ANI's results of
operations.
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 (in
2019), 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,
the appointment of an Interim President and CEO and our
ongoing CEO search 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; the ability to identify and attract qualified
candidates for the President and Chief Executive Officer position,
the length of time before a successor is appointed and potential
disruption in the management team during the transition
period; 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
Statement of Operations
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$49,774
|
|
$52,887
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
Cost of sales (excl. depreciation and amortization)
|
|
21,804
|
|
14,725
|
|
Research and
development
|
|
6,344
|
|
4,373
|
|
Selling, general, and
administrative
|
|
13,683
|
|
13,284
|
|
Depreciation and
amortization
|
|
11,183
|
|
16,103
|
|
Cortrophin pre-launch
charges
|
|
4,602
|
|
-
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
|
57,616
|
|
48,485
|
|
|
|
|
|
|
|
Operating
(Loss)/Income
|
|
(7,842)
|
|
4,402
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
Interest
expense, net
|
|
(2,032)
|
|
(3,354)
|
|
Other
income/(expense), net
|
|
10
|
|
(130)
|
|
|
|
|
|
|
|
(Loss)/Income Before
Benefit/(Provision) for Income Taxes
|
|
(9,864)
|
|
918
|
|
|
|
|
|
|
|
Benefit/(Provision)
for Income Taxes
|
|
2,853
|
|
(469)
|
|
|
|
|
|
|
|
Net
(Loss)/Income
|
|
$ (7,011)
|
|
$
449
|
|
|
|
|
|
|
|
(Loss)/Earnings
Per Share
|
|
|
|
|
|
Basic (Loss)/Earnings
Per Share
|
|
$
(0.59)
|
|
$
0.04
|
|
Diluted
(Loss)/Earnings Per Share
|
|
$
(0.59)
|
|
$
0.04
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
11,902
|
|
11,747
|
|
Diluted
Weighted-Average Shares Outstanding
|
|
11,902
|
|
11,823
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 2: US GAAP
Balance Sheets
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
2020
|
|
December 31,
2019
|
Current
Assets
|
|
|
|
|
Cash and cash equivalents
|
|
$
20,414
|
|
$
62,332
|
Accounts receivable, net
|
|
82,379
|
|
72,129
|
Inventories, net
|
|
52,902
|
|
48,163
|
Prepaid income taxes
|
|
-
|
|
1,076
|
Prepaid expenses and other current assets
|
|
2,967
|
|
3,995
|
|
|
|
|
|
Total
Current Assets
|
|
158,662
|
|
187,695
|
|
|
|
|
|
Property and
equipment, net
|
|
40,353
|
|
40,551
|
Restricted
cash
|
|
5,002
|
|
5,029
|
Deferred tax assets,
net of deferred tax liabilities and valuation allowance
|
|
57,906
|
|
38,326
|
Intangible assets,
net
|
|
215,619
|
|
180,388
|
Goodwill
|
|
3,580
|
|
3,580
|
Other non-current
assets
|
|
1,110
|
|
1,220
|
|
|
|
|
|
Total
Assets
|
|
$482,232
|
|
$
456,789
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
Current debt, net of deferred financing costs
|
|
$
11,872
|
|
$
9,941
|
Accounts payable
|
|
12,485
|
|
14,606
|
Accrued expenses and other
|
|
4,378
|
|
2,362
|
Accrued royalties
|
|
6,285
|
|
5,084
|
Accrued compensation and related expenses
|
|
3,151
|
|
3,736
|
Current income taxes payable, net
|
|
15,223
|
|
-
|
Accrued government rebates
|
|
8,030
|
|
8,901
|
Returned goods reserve
|
|
17,614
|
|
16,595
|
Deferred revenue
|
|
318
|
|
451
|
|
|
|
|
|
Total
Current Liabilities
|
|
79,356
|
|
61,676
|
|
|
|
|
|
Non-current debt, net
of deferred financing costs and current borrowing
component
|
|
188,094
|
|
175,808
|
Other non-current
long-term liabilities
|
|
13,611
|
|
6,514
|
|
|
|
|
|
Total
Liabilities
|
|
281,061
|
|
243,998
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
Common
stock
|
|
1
|
|
1
|
Treasury
stock
|
|
(1,211)
|
|
(723)
|
Additional paid-in
capital
|
|
203,505
|
|
200,800
|
Retained
earnings
|
|
10,565
|
|
17,584
|
Accumulated other
comprehensive loss, net of tax
|
|
(11,689)
|
|
(4,871)
|
|
|
|
|
|
Total
Stockholders' Equity
|
|
201,171
|
|
212,791
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity
|
|
$482,232
|
|
$
456,789
|
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
March 31,
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
Net
(Loss)/Income
|
|
$ (7,011)
|
|
$
449
|
|
|
|
|
|
|
|
|
Add/(Subtract):
|
|
|
|
|
|
|
Interest expense,
net
|
|
2,032
|
|
3,354
|
|
|
Other
(income)/expense, net, less loss on and expense on repurchase
of convertible debt
|
|
(10)
|
|
130
|
|
|
(Benefit)/provision
for income taxes
|
|
(2,853)
|
|
469
|
|
|
Depreciation and
amortization
|
|
11,183
|
|
16,103
|
|
|
Cortrophin pre-launch
charges
|
|
4,602
|
|
-
|
|
|
Stock-based
compensation
|
|
2,424
|
|
1,710
|
|
|
Acquired IPR&D
expense
|
|
3,784
|
|
-
|
|
|
Asset
impairments(1)
|
|
752
|
|
-
|
|
|
Excess of fair value
over cost of acquired inventory
|
|
2,651
|
|
-
|
|
|
Transaction and
integration expenses
|
|
-
|
|
84
|
|
|
Adjusted non-GAAP
EBITDA
|
|
$17,554
|
|
$22,299
|
|
|
|
|
|
|
|
|
|
(1)Asset
Impairments comprised of finished goods inventory reserve for
Bretylium and accounts receivable
|
reserve due to customer bankruptcy, tempered by modest recovery of
previously reserved inventory
|
related to market exits.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
March 31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
Net
(Loss)/Income
|
|
$ (7,011)
|
|
$
449
|
|
|
|
|
|
|
|
Add/(Subtract):
|
|
|
|
|
|
Non-cash interest expense
|
|
157
|
|
1,799
|
|
Depreciation and amortization expense
|
|
11,183
|
|
16,103
|
|
Cortrophin pre-launch charges
|
|
4,602
|
|
-
|
|
Acquired IPR&D expense
|
|
3,784
|
|
-
|
|
Stock-based compensation
|
|
2,424
|
|
1,710
|
|
Excess of fair value over cost of acquired inventory
|
|
2,651
|
|
-
|
|
Asset Impairments(1)
|
|
752
|
|
-
|
|
Transaction and integration expenses
|
|
-
|
|
84
|
|
Less
|
|
|
|
|
|
Tax
impact of adjustments
|
|
(6,133)
|
|
(4,727)
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
|
$12,409
|
|
$15,418
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
|
Shares
Outstanding
|
|
11,902
|
|
11,823
|
|
Adjusted Diluted
Weighted-Average
|
|
|
|
|
|
Shares
Outstanding
|
|
11,945
|
|
11,823
|
|
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
|
Diluted Earnings per Share
|
|
$
1.04
|
|
$
1.30
|
|
|
|
|
|
|
|
(1)Asset
Impairments comprised of finished goods inventory reserve for
Bretylium and accounts receivable
|
reserve due to customer bankruptcy, tempered by modest recovery of
previously reserved inventory
|
related to market exits.
|
|
|
|
|
|
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 Batches of 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
|
Complete
|
sNDA
Submission
|
4 months
|
• In process of
requesting Type-A meeting with FDA to address comments received in
RTF letter
|
In
Progress
|
View original
content:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-first-quarter-2020-results-and-appoints-interim-ceo-301054540.html
SOURCE ANI Pharmaceuticals, Inc.