|
BAUDETTE, Minn., Feb. 27, 2018 /PRNewswire/ --
For the full year ended December 31, 2017:
For the fourth quarter 2017:
Guidance for 2018:
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. 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 Adjusted non- Number of
Revenue GAAP EBITDA(c) 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 2018 Guidance % Increase
Actual 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:
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.
Cortrophin® Gel Re-commercialization Update In the fourth quarter of 2017, ANI has continued to advance the manufacture of Corticotropin active pharmaceutical ingredient ("API"), now successfully manufacturing three intermediate scale batches of API. All three intermediate scale batches of API exhibit lot-to-lot consistency across many different chemical and biological test methods that we continue to employ in building our comprehensive characterization package. These methods are also being utilized to successfully demonstrate comparability to historically manufactured commercial lots of API. ANI has ordered the capital equipment necessary for commercial scale API manufacturing and soon plans to qualify this equipment for cGMP commercial scale manufacturing. We plan to initiate commercial scale API manufacturing in early 2018 and hope to initiate process validation and registration batch manufacturing by the end of 2018. ANI executed a long-term commercial supply agreement with its existing Corticotropin API manufacturer and has now secured the long-term supply for both Corticotropin API and for the finished goods - Cortrophin® gel drug product. We have begun to manufacture development scale batches of Cortrophin® gel in the fourth quarter of 2017, whereby the Cortrophin® gel batches are using the API from our recently manufactured intermediate scale batches. ANI requested a Type C meeting with the FDA in the fourth quarter of 2017 to provide the regulatory plan for re-commercialization of Cortrophin® gel. The FDA granted the Type C meeting with an FDA response scheduled to occur by the end of the first quarter of 2018. For further details, please see ANI's Cortrophin® Gel Re-commercialization Milestone Update in Table 5. Vancocin® Oral Solution Update ANI is currently advancing a commercialization effort for Vancocin® oral solution. Following completion of ongoing formulation and manufacturing optimization, ANI intends to file a prior approval supplement ("PAS") in the second half of 2018. This product will be manufactured at ANI's site in Baudette, MN. The launch of this product will fulfill a currently unmet patient need for an FDA approved liquid oral dosage form of the vancomycin molecule. This product will compete in a market that currently exceeds $450 million annually. When launched, ANI estimates that Vancocin® oral solution could achieve peak sales potential of $50 million. Fourth Quarter Results Net Revenues Three Months Ended
December 31,
(in thousands)
2017 2016 Change % Change
---- ---- ------ --------
Generic
pharmaceutical
products $29,829 $29,296 $533 2%
Branded
pharmaceutical
products 15,521 6,524 8,997 138%
Contract
manufacturing 1,895 1,560 335 21%
Contract
services and
other income 41 825 (784) (95)%
--- --- ---- ----
Total net
revenues $47,286 $38,205 $9,081 24%
======= ======= ======
For the three months ended December 31, 2017, ANI reported net revenues of $47.3 million, an increase of 24% from $38.2 million in the prior year period, due to the following factors:
Operating expenses increased to $39.9 million for the three months ended December 31, 2017, from $36.9 million in the prior year period. The increase was primarily due to a $3.5 million increase in cost of sales as compared with the prior period, as a result of $2.9 million of cost of sales related to the net inventory step-up on Inderal® XL and InnoPran XL® inventory, higher sales of products sold with profit-sharing arrangements, and increased volume. In addition, research and development increased by $2.5 million as compared with the prior period, primarily due to work on the Cortrophin® gel re-commercialization and Vancocin® oral solution projects. Excluding the $2.9 million of net inventory step-up costs related to sales of Inderal® XL and InnoPran XL® in the fourth quarter of 2017 and the $2.8 million of net inventory step-up costs related to sales of Inderal® LA and Propranolol ER in the fourth quarter of 2016, cost of sales remained relatively consistent at 37% of net revenues. Net loss was $9.6 million for the three months ended December 31, 2017, as compared to net loss of $1.1 million in the prior year period. The net loss was primarily due to a $13.4 million charge recorded as a result of the re-measurement of our net deferred tax assets in relation to the tax rate decrease established in the Tax Cuts and Jobs Act, which was enacted on December 22, 2017. Changes in tax rates and tax laws are accounted for in the period of enactment, therefore the charge was recorded in the three months ended December 31, 2017. The effective tax rate for the three months ended December 31, 2017 was 321%, 308% of which related to the charge from the Tax Cuts and Jobs Act. Diluted loss per share for the three months ended December 31, 2017 was $0.83, based on 11,560 thousand diluted shares outstanding and including a $1.16 of impact from the charge related to the Tax Cuts and Jobs Act, as compared to diluted loss per share of $0.09 in the prior year period. Adjusted non-GAAP diluted earnings per share was $1.08, as compared to adjusted non-GAAP diluted earnings per share of $0.90 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. Results for Year Ended December 31, 2017 Net Revenues Year Ended
December 31,
(in thousands)
2017 2016 Change % Change
---- ---- ------ --------
Generic
pharmaceutical
products $118,437 $95,201 $23,236 24%
Branded
pharmaceutical
products 50,919 26,443 24,476 93%
Contract
manufacturing 7,046 5,537 1,509 27%
Contract
services and
other income 440 1,441 (1,001) (70)%
--- ----- ------ ----
Total net
revenues $176,842 $128,622 $48,220 37%
======== ======== =======
For the year ended December 31, 2017, ANI reported net revenues of $176.8 million, an increase of 37% from $128.6 million in the prior year period, due to the following factors:
Operating expenses increased to $148.5 million for the year ended December 31, 2017, from $108.5 million in the prior year period. The increase was primarily due to a $30.3 million increase in cost of sales as compared with the prior period, as a result of higher sales of products sold with profit-sharing arrangements, increased volume, and $10.4 million of cost of sales related to the inventory step-up on Inderal® XL, InnoPran XL®, and Inderal® LA inventory. In addition, research and development increased by $6.2 million as compared with the prior period, primarily due to work on the Cortrophin® gel re-commercialization and Vancocin® oral solution projects. Excluding the $10.4 million of net inventory step-up costs related to sales of Inderal® XL, InnoPran XL®, and Inderal® LA in the year ended December 31, 2017 and $5.9 million of net inventory step-up costs related to sales of Inderal® LA and Propranolol ER in the year ended December 31, 2016, cost of sales increased as a percentage of net revenues to 39% from 33%, primarily as a result of increased sales of products with profit-sharing arrangements. Net loss was $1.1 million for the year ended December 31, 2017, as compared to net income of $3.9 million in the prior year period. The net loss was primarily due to a $13.4 million charge recorded as a result of the re-measurement of our net deferred tax assets in relation to the tax rate decrease established in the Tax Cuts and Jobs Act, which was enacted on December 22, 2017. Changes in tax rates and tax laws are accounted for in the period of enactment, therefore the charge was recorded in the year ended December 31, 2017. The effective tax rate for the year ended December 31, 2017 was 107%, 82% of which related to the charge from the Tax Cuts and Jobs Act. Diluted loss per share for the year ended December 31, 2017 was $0.09, based on 11,547 thousand diluted shares outstanding and including a $1.16 of impact from the charge related to the Tax Cuts and Jobs Act, as compared to diluted earnings per share of $0.34 in the prior year period. Adjusted non-GAAP diluted earnings per share was $3.91, as compared to adjusted non-GAAP diluted earnings per share of $2.96 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. Selected Balance Sheet Data (in thousands) December 31, 2017 December 31, 2016
----------------- -----------------
Cash $31,144 $27,365
Accounts
receivable, net $58,788 $45,895
Inventory, net $37,727 $26,183
Current assets $131,605 $103,007
Current liabilities $39,228 $31,948
Non-current debt $198,154 $120,643
ANI generated $39.4 million of cash flow from operations in the year ended December 31, 2017. In February 2017, ANI purchased from Cranford Pharmaceuticals, LLC a distribution license, trademark, and certain finished goods inventory for Inderal® XL for $20.2 million in cash, using cash on hand. In February 2017, ANI purchased from Holmdel Pharmaceuticals, LP the NDA, trademark, and certain finished goods inventory for InnoPran XL®, including a license to an Orange Book listed patent, for $30.6 million in cash. ANI made the $30.6 million cash payment using $30.0 million of funds from its line of credit and $0.6 million of cash on hand. In December 2017, ANI purchased from AstraZeneca AB and AstraZeneca UK Limited the right, title, and interest in the NDAs and the U.S. rights to market Atacand®, Atacand HCT®, Arimidex®, and Casodex®, for $46.5 million in cash. ANI made the $46.5 million cash payment with funds from a $75.0 million five-year term loan entered into with Citizens Bank N.A. in December 2017. The funds from the term loan were also used to pay down the $25.0 million remaining balance on the line of credit. ANI Product Development Pipeline ANI's pipeline consists of 74 products, addressing a total annual market size of $3.1 billion, based on data from IMS Health. Of these 74 products, 51 were acquired and of these acquired products, ANI expects that 44 can be commercialized based on either CBE-30s or prior approval supplements filed with the FDA. Non-GAAP Financial Measures The Company's fiscal 2018 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, costs related to major transactions not consummated, and other income / expense. 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, costs related to major transactions not consummated, non-cash interest expense, depreciation and amortization expense, and non-cash impairment charges, 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. 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:
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 1: US GAAP Income Statement
(unaudited, in thousands, except per share amounts)
Three Months Ended December 31, Year Ended December 31,
2017 2016 2017 2016
---- ---- ---- ----
Net Revenues $47,286 $38,205 $176,842 $128,622
Operating Expenses
Cost of sales (excl. depreciation and
amortization) 20,446 16,906 79,032 48,780
Research and development 2,651 135 9,070 2,906
Selling, general, and administrative 8,885 7,369 31,580 27,829
Depreciation and amortization 7,022 5,812 27,928 22,343
Intangible asset impairment charge 903 6,685 903 6,685
Total Operating Expenses 39,907 36,907 148,513 108,543
Operating Income 7,379 1,298 28,329 20,079
Other Expense, Net
Interest expense, net (3,026) (2,859) (12,035) (11,327)
Other (expense)/income, net (3) (43) 55 (74)
Income/(Loss) Before (Provision)/
Benefit for Income Taxes 4,350 (1,604) 16,349 8,678
(Provision)/Benefit for Income Taxes (13,979) 524 (17,425) (4,744)
Net (Loss)/Income $(9,629) $(1,080) $(1,076) $3,934
(Loss)/Earnings Per Share
Basic (Loss)/Earnings Per Share $(0.83) $(0.09) $(0.09) $0.34
Diluted (Loss)/Earnings Per Share $(0.83) $(0.09) $(0.09) $0.34
Basic Weighted-Average Shares
Outstanding 11,560 11,516 11,547 11,445
Diluted Weighted-Average Shares
Outstanding 11,560 11,516 11,547 11,573
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 2: US GAAP Balance Sheets
(in thousands)
December 31, December 31,
2017 2016
---- ----
Current Assets
Cash and cash equivalents $31,144 $27,365
Accounts receivable, net 58,788 45,895
Inventories, net 37,727 26,183
Prepaid income taxes 1,162 -
Prepaid expenses and other
current assets 2,784 3,564
Total Current Assets 131,605 103,007
Property and equipment, net 20,403 10,998
Restricted cash 5,006 5,002
Deferred tax asset, net of
valuation allowance 22,667 26,227
Intangible assets, net 229,790 175,792
Goodwill 1,838 1,838
Other long-term assets 829 -
Total Assets $412,138 $322,864
Current Liabilities
Accounts payable $3,630 $3,389
Accrued expenses and other 1,571 927
Accrued royalties 12,164 11,956
Accrued compensation and
related expenses 2,306 1,631
Current income taxes payable - 2,398
Accrued government rebates 7,930 5,891
Returned goods reserve 8,274 5,756
Current component of long-term borrowing, net
of deferred financing costs 3,353 -
Total Current Liabilities 39,228 31,948
Long-term royalties - 625
Long-term borrowing, net of deferred
financing costs and current borrowing
component 69,946 -
Convertible notes, net of discount and
deferred financing costs 128,208 120,643
Total Liabilities 237,382 153,216
Stockholders' Equity
Common stock 1 1
Treasury stock (259) -
Additional paid-in capital 179,020 172,563
Accumulated deficit (4,006) (2,916)
Total Stockholders' Equity 174,756 169,648
Total Liabilities and
Stockholders' Equity $412,138 $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 December 31, Year Ended December 31,
2017 2016 2017 2016
---- ---- ---- ----
Net (Loss)/Income $(9,629) $(1,080) $(1,076) $3,934
Add back
Interest expense, net 3,026 2,859 12,035 11,327
Other income/(expense), net 3 43 (55) 74
Provision/(benefit) for
income taxes 13,979 (524) 17,425 4,744
Depreciation and
amortization 7,022 5,812 27,928 22,343
Intangible asset impairment
charge 903 6,685 903 6,685
Add back
Stock-based compensation 1,422 1,380 6,090 6,067
Excess of fair value over
cost of acquired inventory 2,946 2,758 10,448 5,938
Expenses related to
transaction not consummated - - 477 -
--- --- --- ---
Adjusted non-GAAP EBITDA $19,672 $17,933 $74,175 $61,112
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 December 31, Year Ended December 31,
2017 2016 2017 2016
---- ---- ---- ----
Net (Loss)/Income $(9,629) $(1,080) $(1,076) $3,934
Add back
Excess of fair value over
cost of acquired inventory 2,946 2,758 10,448 5,938
Non-cash interest expense 1,758 1,784 7,113 7,048
Stock-based compensation 1,422 1,380 6,090 6,067
Depreciation and
amortization expense 7,022 5,812 27,928 22343
Intangible asset impairment
charge 903 6,685 903 6,685
Expenses related to
transaction not consummated - - 477 -
--- --- --- ---
Less
Tax impact of adjustments (5,199) (6,815) (19,595) (17,790)
Add back
Impact of Tax Cuts and Jobs
Act of 2017 on Deferred Tax
Assets 13,394 - 13,394 -
Adjusted non-GAAP Net Income $12,617 $10,524 $45,682 $34,225
Diluted Weighted-Average
Shares Outstanding 11,723 11,635 11,680 11,573
Adjusted non-GAAP
Diluted Earnings per Share $1.08 $0.90 $3.91 $2.96
----- ----- ----- -----
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 5: Cortrophin(R) Gel Re-Commercialization Milestone Update
Step Duration Status Additional Details
---- -------- ------ ------------------
Manufacture small-
scale batch of
corticotropin API 4 mos. Complete •Initial batch yields similar to historical yields
------------------ ------ --------
•Analytical method development and
testing ongoing
----------------------------------
Select drug product
CMO 6 mos. Complete • Drug product CMO has been selected
------------------- ------ -------- ------------------------------------
Manufacture •Three intermediate-scale batches successfully
intermediate-scale completed
batches of
corticotropin API 4-6 mos. Complete
------------------- -------- --------
•Further refined/modernized
analytical methods and process
•Demonstrated lot-to-lot consistency
------------------------------------
Type C meeting with FDA FDA Response March 2018 • Meeting Request submitted 4Q17; FDA granted as
Type C Meeting
------------------------- -----------------------
• Information provided on ANI's
regulatory plan for re-
commercialization
• FDA response scheduled for March
2018
----------------------------------
Manufacture demo •Initiate formulation /fill /finish of drug
batches of product
Cortrophin(R) Gel TBD Target Q2 2018
------------------ --- -------------- --------------------------------------------
Manufacture
commercial-scale
batches of
corticotropin API 2-3 mos. per batch Target 1H 2018 • Scale-up manufacturing process 5x
------------------ ------------------ --------------
• Manufacture API under cGMPs
• Finalize API manufacturing process
in prepration for process
validation/registration batches
------------------------------------
Manufacture
registration batches
of Cortrophin(R) Gel 2-3 mos. per batch Target end 2018 • Process validation
--------------------- ------------------ ---------------
• Registration / Commercial batches
• Initiate registration-enabling
ICH stability studies
--------------------------------
Initiate registration 6 mos. TBD •Six months of accelerated stability from drug
stability for sNDA substance and drug product batches at time of
submission
--------------------- ------ --- -----------------------------------------------
sNDA submission TBD TBD •PAS filing - four month PDUFA date
--------------- --- --- -----------------------------------
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 6: Historical Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation
(unaudited, in thousands)
Year Ended December 31,
2015 2014 2013
---- ---- ----
Net Income from Continuing Operations $15,375 $28,747 $106
Add back
Interest expense, net 11,008 787 467
Other (expense)/income, net (41) (160) 305
Provision/(benefit) for income taxes 6,358 (9,368) 20
Depreciation and amortization 6,900 3,878 1,110
Add back
Stock-based compensation 3,856 3,423 36
Merger-related expenses - - 5,468
--- --- -----
Adjusted non-GAAP EBITDA $43,456 $27,307 $7,512
View original content:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-record-full-year-results-reports-fourth-quarter-2017-results-and-provides-2018-guidance-300604056.html SOURCE ANI Pharmaceuticals, Inc. |
Company Codes: NASDAQ-NMS:ANIP |
