ANI Pharmaceuticals Reports Full Year and Fourth Quarter 2019 Results, Provides 2020 Guidance and Remains on Track to Submit Cortrophin® Gel sNDA to FDA in March 2020

BAUDETTE, Minn., Feb. 27, 2020 /PRNewswire/ —

For the full year ended December 31, 2019:

  • Record net revenues of $206.5 million, an increase of 2.5% versus 2018
  • GAAP net income of $6.1 million and diluted GAAP earnings per share of $0.50
  • Adjusted non-GAAP EBITDA of $83.2 million
  • Adjusted non-GAAP diluted earnings per share of $5.06

For the fourth quarter 2019:

  • Net revenues of $48.0 million versus $57.1 million in 2018
  • GAAP net loss of $4.8 million and diluted GAAP loss per share of $0.41
  • Adjusted non-GAAP EBITDA of $17.4 million
  • Adjusted non-GAAP diluted earnings per share of $1.08

Guidance for 2020:

  • Net revenues of $213 million to $223 million
  • Adjusted non-GAAP EBITDA of $80 million to $86 million
  • Adjusted non-GAAP diluted earnings per share of $4.46 to $4.86

ANI Pharmaceuticals, Inc. (“ANI”) (NASDAQ: ANIP) today reported its financial results for the three and twelve months ended December 31, 2019 and provided its 2020 financial guidance. The Company will host its earnings conference call this morning, February 27, 2020, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (866) 776-8875. The conference ID is 4783883.

Financial Summary

(in thousands, except per share data)


Q4 2019


Q4 2018


    2019(a)


  2018(a)

Net revenues


$ 47,966


$ 57,122


$ 206,547


$ 201,576

Net (loss)/income


$  (4,835)


$   5,430


$     6,094


$   15,494

GAAP (loss)/earnings per diluted share


$    (0.41)


$     0.46


$       0.50


$       1.30

Adjusted non-GAAP EBITDA(b)


$ 17,383


$ 22,184


$   83,158


$   84,401

Adjusted non-GAAP diluted earnings per share(c)


$     1.08


$     1.32


$       5.06


$       5.07


(a) See ANI’s Form 10-K filed February 27, 2020 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,

“ANI generated record net revenues and non-GAAP gross profit in 2019 while continuing to diversify its commercial product offering and pipeline opportunities.  While revenues and non-GAAP gross profit for three of our important generic products were negatively impacted in recent periods, overall our business remains resilient, and we look forward to leveraging important recent launches such as Vancomycin Oral Solution and Bretylium Tosylate Injection as well as the recently acquired Amerigen portfolio in 2020.  During 2019, we launched several new products, entered into collaborative arrangements with strategic partners and acquired both previously approved and development stage products we plan to launch in the future. We have utilized strong operating cash flows for asset acquisitions and investment into our portfolio of pipeline products and expect to continue to do so in the future.

During the fourth quarter, we successfully completed our fourth commercial scale batch of both Corticotropin API and the Cortrophin® Gel drug product, and importantly, remain on track to submit our supplemental NDA filing in March 2020.”

2020 Financial Guidance

For the twelve months ending December 31, 2020, ANI is providing guidance on net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share. The following table summarizes 2020 guidance as compared to 2019 actual results:

($ in millions except per share data)

2019


2020 Guidance Range


% Change from Prior Year


Actual


Low

Mid

High


Low

Mid

High











Net Revenues

$     206.5


$     213.0

$     218.0

$     223.0


3%

6%

8%











Adjusted non-GAAP EBITDA

$      83.2


$      80.0

$      83.0

$      86.0


-4%

0%

3%











Adjusted non-GAAP diluted earnings per share

$      5.06


$      4.46

$      4.66

$      4.86


-12%

-8%

-4%

In addition, we expect that adjusted non-GAAP gross margin, defined as the result of Net Revenues less Cost of Sales (excluding depreciation and amortization) as a percentage of Net Revenues, will decline from approximately 71% in 2019 to the mid 60% range in 2020, driven by the impact of negative price and product mix. Year over year changes of our Adjusted non-GAAP diluted earnings per share metric differ from our Adjusted non-GAAP EBITDA metric due to a projected increase in cash interest expense resulting from the refinancing of our convertible debt to bank debt.

ANI’s full year 2020 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.

Cortrophin® Gel Re-commercialization Update

Product

Required Filing

Expected Filing Date

Total Annual Market(d)

Cortrophin® Gel

sNDA

March 2020

   $1.0 billion


(d) Based on data from IQVIA

We continue to successfully progress our Cortrophin® Gel re-commercialization program. Significant accomplishments since the third quarter 2019 press release (dated November 6, 2019) include:

  • ANI successfully completed API process validation by completing the fourth commercial scale batch of Corticotropin API.  ANI also completed manufacturing for a fifth commercial scale batch of Corticotropin API.  All five commercial scale batches were analytically consistent with each other and met all API release specifications.  ANI expects to have 6 months stability on all API registration batches prior to the sNDA filing and by the end of first quarter 2020.
  • ANI successfully completed drug product process validation in the fourth quarter of 2019. ANI also completed manufacturing of a fourth commercial scale batch of Cortrophin® Gel. This batch was analytically consistent with previously manufactured batches and met all drug product release specifications. ANI had already completed manufacturing for three commercial scale registration stability batches of Cortrophin® Gel and expects to have 6 months stability on each prior to the sNDA filing and by the end of first quarter 2020. 

ANI is on track to file the sNDA as planned by March 2020.

For further details, please see ANI’s Cortrophin® Gel Re-commercialization Milestone Update in Table 5.

Fourth Quarter Results

Net Revenues

(in thousands)


Three Months Ended

December 31,








2019


2018


Change


% Change

Generic pharmaceutical products


$

29,121


$

33,735


$

(4,614)


(14)%

Branded pharmaceutical products



15,624



18,840



(3,216)


(17)%

Contract manufacturing



2,640



3,669



(1,029)


(28)%

Royalty and other income



581



878



(297)


(34)%

Total net revenues


$

47,966


$

57,122


$

(9,156)


(16)%















Generic Pharmaceutical Products

Fourth Quarter Net Revenues – Results and Update

Net revenues from sales of generic pharmaceuticals decreased 14% to $29.1 million from $33.7 million in the prior period, primarily due to decreases in sales of Esterified Estrogen with Methlytestosterone (“EEMT”), Erythromycin Ethylsuccinate (“EES”), Propafenone, and Fenofibrate. These decreases were tempered by the September 2019 launch of Vancomycin HCl for Oral Solution as well as increased unit sales of Vancomycin tablets.

Branded Pharmaceutical Products

Fourth Quarter Net Revenues – Results and Update

Net revenues from sales of branded pharmaceuticals decreased 17% to $15.6 million from $18.8 million in the prior period, primarily due to decrease in sales of Inderal® LA, Atacand® and Atacand HCT®. These decreases were tempered by increased sales of InnoPran XL®.

Contract Manufacturing 

Fourth Quarter Net Revenues – Results and Update

Contract manufacturing revenues decreased 28% to $2.6 million from $3.7 million in the prior year period, due to the timing and volume of orders from contract manufacturing customers in the period.  

Royalty and Other

Fourth Quarter Net Revenues – Result and Update

Royalty and Other decreased 34% to $0.6 million from $0.9 million, primarily due to the timing and volume of product development and laboratory services revenue earned by ANI Canada.

Operating Expenses

Operating expenses increased to $52.6 million for the three months ended December 31, 2019, from $45.7 million in the prior year period. The increase was primarily due to the following:

  • $6.5 million in the build of Cortrophin pre-launch commercial inventories (which are expensed for US GAAP); there were no such activities in 2018,
  • $1.2 million increase in research and development expense, primarily due to Q4 2019 development-based milestone payments earned by collaborative partners, and 
  • $0.9 million increase in depreciation and amortization expense, 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 $2.3 million decrease in cost of sales as a result of the previously mentioned royalty buyout in January 2019 and a decrease in sales over the comparable periods, tempered by Q4 2019 inventory reserve charges of $4.6 million primarily related to the Company’s exit from the Methylphenidate Extended Release market.

Cost of sales as a percentage of net revenues increased to 37% during the three months ended December 31, 2019, from 35% during same period in 2018. The increase was primarily due to the inventory reserve charges recognized in the fourth quarter 2019 and negative price, which were tempered by reductions related to the 2019 royalty buyout.

Net Loss and Diluted Loss per Share

Net loss was $4.8 million for the three months ended December 31, 2019, as compared to net income of $5.4 million in the prior year period. The net loss was driven by the previously mentioned $6.5 million build of Cortrophin pre-launch commercial inventories and $4.6 million of inventory reserve charges.  The effective consolidated tax benefit rate for the three months ended December 31, 2019 was 37%.

Diluted loss per share for the three months ended December 31, 2019 was $0.41, based on 11,886 thousand diluted shares outstanding, as compared to diluted earnings per share of $0.46 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 $1.32 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 118 products, addressing a total annual market size of $7.0 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

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, non-cash impairment charges, Cortrophin pre-launch charges, other income / expense and certain other items, including expensed milestone payments and inventory reserve charges, 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, non-cash impairment charges, Cortrophin pre-launch charges and certain other items, including expensed milestone payments and inventory reserve charges, 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/(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, including expensed milestone payments and inventory reserve charges, 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, non-cash impairment charges, Cortrophin pre-launch charges and certain other items, including expensed milestone payments and inventory reserve charges, 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, 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 Statement of Operations

(unaudited, in thousands, except per share amounts)





















Three Months Ended

December 31,


Year Ended

December 31,



2019


2018


2019


2018










Net Revenues


$47,966


$57,122


$206,547


$201,576










Operating Expenses









   Cost of sales (excl. depreciation









        and amortization)


17,795


20,133


63,154


73,024

Research and development


4,678


3,482


19,806


15,388

Selling, general, and administrative


14,014


13,376


55,843


44,063

Depreciation and amortization


9,564


8,686


44,612


33,742

Cortrophin pre-launch charges


6,511



6,706


Intangible asset impairment charge


75



75











Total Operating Expenses


52,637


45,677


190,196


166,217










     Operating (Loss)/Income


(4,671)


11,445


16,351


35,359










Other Expense, Net









   Interest expense, net


(2,870)


(3,626)


(12,966)


(14,758)

   Other expense, net


(111)


(479)


(228)


(550)










(Loss)/Income Before Benefit/(Provision) for Income Taxes


(7,652)


7,340


3,157


20,051










Benefit/(Provision) for Income Taxes


2,817


(1,910)


2,937


(4,557)










Net (Loss)/Income


$ (4,835)


$  5,430


$    6,094


$  15,494










(Loss)/Earnings Per Share









Basic (Loss)/Earnings Per Share


$   (0.41)


$    0.46


$     0.51


$     1.31

Diluted (Loss)/Earnings Per Share


$   (0.41)


$    0.46


$     0.50


$     1.30










Basic Weighted-Average Shares Outstanding


11,886


11,730


11,841


11,677

Diluted Weighted-Average Shares Outstanding


11,886


11,785


12,040


11,772

ANI Pharmaceuticals, Inc. and Subsidiaries

Table 2: US GAAP Balance Sheets

(in thousands)










December 31,

2019


December 31,

2018

Current Assets




    Cash and cash equivalents

$         62,332


$         43,008

    Accounts receivable, net

72,129


64,842

    Inventories, net

48,163


40,503

    Prepaid income taxes, net

1,076


    Prepaid expenses and other current assets

3,995


4,524





        Total Current Assets

187,695


152,877





Property and equipment, net

40,551


38,090

Restricted cash

5,029


5,021

Deferred tax assets, net of deferred tax liabilities and valuation allowance

38,326


27,964

Intangible assets, net

180,388


201,604

Goodwill

3,580


3,580

Other non-current assets

1,220


1,468





       Total Assets

$       456,789


$       430,604





Current Liabilities




    Current component of Term Loan and DDTL, net of deferred financing costs

$          9,941


$          3,256

    Convertible Notes, net of discount and deferred financing costs


112,463

    Accounts payable 

14,606


8,884

    Accrued expenses and other

2,362


1,707

    Accrued royalties 

5,084


8,456

    Accrued compensation and related expenses

3,736


3,524

    Current income taxes payable, net


5,022

    Accrued government rebates

8,901


8,974

    Returned goods reserve

16,595


12,552

    Deferred revenue

451


711





        Total Current Liabilities 

61,676


165,549





Term Loan and DDTL, net of deferred financing costs and current borrowing component

175,808


67,296

Other non-current long-term liabilities

6,514


496





       Total Liabilities

243,998


233,341





Stockholders’ Equity




Common stock

1


1

Treasury stock

(723)


(659)

Additional paid-in capital

200,800


186,812

Retained earnings

17,584


11,488

Accumulated other comprehensive loss, net of tax

(4,871)


(379)





       Total Stockholders’ Equity

212,791


197,263





       Total Liabilities and Stockholders’ Equity

$       456,789


$       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

December 31,


Year Ended

December 31,



2019


2018


2019


2018










Net (Loss)/Income


$ (4,835)


$  5,430


$  6,094


$15,494










Add/(Subtract):









Interest expense, net


2,870


3,626


12,966


14,758

Other (income)/expense, net, less loss on and expense









  on repurchase of convertible debt


111


(90)


228


(19)

(Benefit)/provision for income taxes


(2,817)


1,910


(2,937)


4,557

Depreciation and amortization


9,564


8,686


44,612


33,742

Cortrophin pre-launch charges


6,511



6,706


Stock-based compensation


2,444


1,828


9,217


6,782

Acquired IPR&D expense




2,324


1,335

Excess of fair value over cost of acquired inventory





5,689

Loss on and expense on repurchase of convertible debt 









   and expense on debt refinancing



691



691

Transaction and integration expenses



103


84


1,372

Intangible asset impairment charge


75



75


Expensed FDA approval milestone payment




329


Inventory reserve charges related to market exits


3,460




3,460


Adjusted non-GAAP EBITDA


$17,383


$22,184


$83,158


$84,401

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,



2019


2018


2019


2018










   Net (Loss)/Income


$ (4,835)


$  5,430


$  6,094


$15,494










Add back









    Non-cash interest expense


1,308


1,903


6,833


7,741

    Depreciation and amortization expense


9,564


8,686


44,612


33,742

    Cortrophin pre-launch charges


6,511



6,706


    Expensed FDA approval milestone payment




329


    Acquired IPR&D expense




2,324


1,335

    Stock-based compensation


2,444


1,828


9,217


6,782

    Inventory reserve charges related to market exits


3,460



3,460


    Intangible asset impairment


75



75


    Excess of fair value over cost of acquired inventory





5,689

    Loss on and expense on repurchase of convertible debt 









       and expense on debt refinancing



691



691

    Transaction and integration expenses



103


84


1,372

Less









   Tax impact of adjustments


(5,607)


(3,039)


(17,674)


(13,191)

 Discrete tax benefit related to ANI Canada transfer pricing agreement



(1,653)











Adjusted non-GAAP Net Income


$12,920


$15,602


$60,407


$59,655










Diluted Weighted-Average









     Shares Outstanding


11,886


11,785


12,040


11,772

Less: dilutive effect of Notes 




(96)


Adjusted Diluted Weighted-Average









     Shares Outstanding


11,980


11,785


11,944


11,772










Adjusted non-GAAP 









    Diluted Earnings per Share


$    1.08


$    1.32


$    5.06


$    5.07

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

On Track

sNDA Submission

4 months

• Target date: March 2020

On Track

• sNDA filing four month PDUFA date:  July 2020


SOURCE ANI Pharmaceuticals, Inc.

Related Links

www.anipharmaceuticals.com

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