Lannett Announces Fiscal 2019 First-Quarter Financial Results; Re-Affirms Adjusted Guidance For Fiscal 2019

PHILADELPHIA, Nov. 7, 2018 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today reported financial results for its fiscal 2019 first quarter ended September 30, 2018.

"For the fiscal 2019 first quarter, net sales and adjusted net income exceeded our expectations," said Tim Crew, chief executive officer of Lannett. "A key driver to our performance was the combined contribution of new products launched since January 1(st) of this year. Our plans for the balance of fiscal 2019 include additional product launches of both recently acquired and internally developed products.

"We made solid progress on other fronts to position the company for continued improvement. During the first quarter and into the current period, we completed several transactions that added a number of attractive market ready products to our portfolio. In addition, we significantly increased our cash position and finalized a cost reduction plan that we expect when fully implemented will generate annualized cost savings of approximately $66 million comparing fiscal 2020 to fiscal 2018 expenses. We plan to re-invest or redeploy approximately $33 million of the cost savings back into our business. The plan includes decreased spending throughout the organization and workforce reductions. As part of the plan, we also intend to sell our Cody Laboratories active pharmaceutical ingredients business, a move that will provide immediate and substantial expense reductions and allow us to better focus on nearer and medium term growth opportunities.

"Given the above, we are excited about our future and accordingly, we have re-affirmed the company's fiscal 2019 adjusted financial guidance."

For the fiscal 2019 first quarter, on a GAAP basis, net sales were $155.1 million compared with $155.0 million for the first quarter of fiscal 2018. Gross profit was $59.1 million, or 38% of total net sales, compared with $67.7 million, or 44% of total net sales. Research and development (R&D) expenses were $9.8 million compared with $7.4 million for the fiscal 2018 first quarter. Selling, general and administrative (SG&A) expenses increased to $20.6 million from $19.0 million. Restructuring expenses were $1.0 million compared with $0.5 million. As previously disclosed, the company recorded in its fiscal 2019 first quarter non-cash charges totaling $369.5 million related to the full impairment of goodwill, resulting from the non-renewal of the distribution agreement with Jerome Stevens Pharmaceuticals when the contract expires in March 2019, and the impairment of certain long-lived assets as a result of the plan to sell its Cody Laboratories API business. Operating loss was $341.8 million compared to operating income of $40.7 million. Interest expense was $21.4 million compared with $20.9 million for the first quarter of fiscal 2018. The company recorded an income tax benefit of $75.6 million versus income tax expense of $7.4 million in the prior-year period. Net loss was $287.5 million, or $7.65 per share, versus net income of $13.3 million, or $0.35 per diluted share, for the fiscal 2018 first quarter.

For the fiscal 2019 first quarter reported on a Non-GAAP basis, adjusted net sales were $155.1 million compared with $155.0 million for the first quarter of fiscal 2018. Adjusted gross profit was $68.7 million, or 44% of adjusted net sales, compared with $76.7 million, or 50% of adjusted net sales, for the prior-year first quarter. Adjusted R&D expenses were $9.8 million compared with $7.4 million. Adjusted SG&A expenses were $19.2 million compared with $18.7 million. Adjusted operating income was $39.6 million compared with $50.7 million for the prior-year first quarter. Adjusted interest expense was $16.9 million compared with $16.4 million for the first quarter of fiscal 2018. Adjusted income tax expense was $5.9 million compared with $12.5 million in the prior-year period. Adjusted net income was $16.9 million, or $0.44 per diluted share, compared with $22.7 million, or $0.60 per diluted share, for the fiscal 2018 first quarter.

Guidance for Fiscal 2019
Based on its current outlook, the company has revised its GAAP estimates to, among other things, include asset impairment charges of $369 million and re-affirmed adjusted financial guidance for the 2019 fiscal year (minor increases to estimates of Net sales and R&D expense), as follows:

                                                        GAAP                         Adjusted



            Net
            sales         
         $585 million to $615 million 
       $585 million to $615 million

    ---

     Gross
     margin
     %                                           38% to 39%                      44% to 45%

    ---

            R&D
            expense         
         $32 million to $36 million   
       $30 million to $34 million

    ---

            SG&A
            expense         
         $75 million to $78 million   
       $63 million to $66 million

    ---

            Restructuring
            expense           
         $3 million to $4 million                    
            $ --

    ---

            Asset
            impairment
            charges                    
            $369 million                    
            $ --

    ---

            Interest
            expense         
         $81 million to $83 million   
       $63 million to $65 million

    ---

            Effective
            tax
            rate                                  22% to 23%                      22% to 23%

    ---

            Capital
            expenditures    
         $30 million to $35 million   
       $30 million to $35 million

    ---

The financial guidance table above includes "Asset impairment charges." This item was not included in the guidance provided on August 28, 2018, because, at that time, the company could not estimate the amount or a reasonable range of amounts of such impairment.

Product Launches / Cost Savings
The company has posted additional information related to new product launches and cost savings on its website. If interested, please visit http://lannett.investorroom.com/news-releases.

Conference Call Information and Forward-Looking Statements
Later today, the company will host a conference call at 4:30 p.m. ET to review its results of operations for its fiscal 2019 first quarter ended September 30, 2018. The conference call will be available to interested parties by dialing 866-436-9172 from the U.S. or Canada, or 630-691-2760 from international locations, passcode 47800134. The call will be broadcast via the Internet at www.lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company's financial status and performance, regulatory and operational developments, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures
This news release contains references to Non-GAAP financial measures, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). Management uses these measures internally for evaluating its operating performance. The Company's management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor's overall understanding of the financial results for the Company's core business. Additionally, it provides a basis for the comparison of the financial results for the Company's core business between current, past and future periods. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP.

Detailed reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included with this release.

Non-GAAP financial measures exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) acquisition and integration-related expenses, (3) non-cash interest expense, as well as (4) certain other items considered unusual or non-recurring in nature.

About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications - see financial schedule below for net sales by medical indication. For more information, visit the company's website at www.lannett.com.

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements, including, but not limited to, the impact of the non-renewal of the distribution agreement with Jerome Stevens Pharmaceuticals, successfully launching and commercializing recently acquired and previously approved products, realizing enhanced efficiencies, successfully consummating transactions with new and existing alliance partners and successfully launching and commercializing products included therein, and achieving the financial metrics stated in the company's guidance for fiscal 2019, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, including acquired products, and Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. These forward-looking statements represent the company's judgment as of the date of this news release. The company disclaims any intent or obligation to update these forward-looking statements.

FINANCIAL SCHEDULES FOLLOW

                                                      
              
                LANNETT COMPANY, INC.


                                                   
              
                CONSOLIDATED BALANCE SHEETS


                                                
              (In thousands, except share and per share data)








                                    ASSETS

    ---

                     Current assets:                                                          September 30, 2018 June 30, 2018



        Cash and cash equivalents                                                                       $150,327        $98,586


        Accounts receivable, net                                                                         205,350        252,651



       Inventories                                                                                      145,915        141,635



       Prepaid income taxes                                                                               1,690         15,159



       Assets held for sale                                                                              13,245         13,976



       Other current assets                                                                               7,859          4,863




       Total current assets                                                                             524,386        526,870


                     Property, plant and equipment,
                      net                                                                                195,880        233,247


                     Intangible assets, net                                                              416,016        424,425


                     Goodwill                                                                                            339,566


                     Deferred tax assets                                                                  99,761         22,063


                     Other assets                                                                         21,612         29,133


                     TOTAL ASSETS                                                                     $1,257,655     $1,575,304







                                    LIABILITIES

    ---

                     Current liabilities:



       Accounts payable                                                                                 $48,558        $56,767



       Accrued expenses                                                                                   5,732          7,425


        Accrued payroll and payroll-
         related expenses                                                                                 10,009          7,819



       Rebates payable                                                                                   36,489         49,400



       Royalties payable                                                                                  5,878          5,955


        Restructuring liability                                                                            6,911          6,706


        Liabilities held for sale                                                                          2,010              -


        Short-term borrowings and
         current portion of long-term
         debt                                                                                             66,845         66,845



        Total current liabilities                                                                        182,432        200,917


                     Long-term debt, net                                                                 760,127        772,425


                     Other liabilities                                                                     3,073          3,047


                     TOTAL LIABILITIES                                                                   945,632        976,389






       
                
                  STOCKHOLDERS' EQUITY

    ---

                     Common stock ($0.001 par value, 100,000,000 shares
                      authorized; 38,665,268 
              and 38,256,839
                      shares issued; 37,734,758 and 37,380,517 shares
                      outstanding at 
              September 30, 2018 and
                      June 30, 2018, respectively)

                                                                                                              39             38


                     Additional paid-in capital                                                          310,135        306,817


                     Retained earnings                                                                    16,653        306,464


                     Accumulated other comprehensive
                      loss                                                                                 (509)         (515)


                     Treasury stock(930,510 and
                      876,322 shares at September
                      30, 2018 and June 30, 2018,
                      respectively)                                                                     (14,295)      (13,889)



        Total stockholders' equity                                                                       312,023        598,915



                     TOTAL LIABILITIES AND
                      STOCKHOLDERS' EQUITY                                                            $1,257,655     $1,575,304

                                                                                                                           ===


                                        
              
                LANNETT COMPANY, INC.


                                
              
                CONSOLIDATED STATEMENTS OF OPERATIONS


                                  
              (In thousands, except share and per share data)




                                                                               (UNAUDITED)


                                                                           Three months ended


                                                                              September 30,



                                                                                         2018       2017





                   Net sales                                                         $155,054   $154,961


                   Cost of sales                                                       87,690     79,553


                   Amortization of intangibles                                          8,223      7,737


                   Gross profit                                                        59,141     67,671



                   Operating expenses:


      Research and development
       expenses                                                                         9,810      7,409


      Selling, general, and
       administrative expenses                                                         20,588     19,038


      Acquisition and integration-
       related expenses                                                                              18


      Restructuring expenses                                                            1,022        527


      Asset impairment charges                                                        369,499



      Total operating expenses                                                        400,919     26,992



                   Operating income (loss)                                          (341,778)    40,679



                   Other income (loss):



     Investment income                                                                   379      1,164



     Interest expense                                                               (21,433)  (20,912)



     Other                                                                             (296)     (251)




     Total other loss                                                               (21,350)  (19,999)



                   Income (loss) before income
                    tax                                                             (363,128)    20,680


                   Income tax expense (benefit)                                      (75,600)     7,423



                   Net income (loss)                                               $(287,528)   $13,257





                   Earnings (loss) per common
                    share:



          Basic                                                                      $(7.65)     $0.36



          Diluted                                                                    $(7.65)     $0.35




                   Weighted average common
                    shares outstanding:



          Basic                                                                   37,586,327 36,992,064



          Diluted                                                                 37,586,327 37,730,656



                                                                                                                                                     
              
                LANNETT COMPANY, INC.


                                                                                                                             
           
                RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (UNAUDITED)


                                                                                                                                        
              (In thousands, except percentages, share and per share data)




                                                                                                                                              
              
                Three months ended September 30, 2018

                                                                                                                                                                           ---

                         
       Net sales     
           Cost of      
             Amortization               Gross         Gross     
           R&D              
              SG&A             
              Restructuring               
              Asset impairment            
          
             Operating          
             Other         
          
                Income (loss)        
            Income tax                    Net income                    Diluted
                                             sales                of intangibles              Profit          Margin %       expense                   expense                         expenses                                 charges                            income (loss)                      income                      before income                        expense                       (loss)                    earnings
                                                                                                                                                                                                                                                                                                       (loss)                           tax                            (benefit)                                               (loss) per
                                                                                                                                                                                                                                                                                                                                                                                                                               share (h)

                                                                                                                                                                                                                                                                                                                                                                                                                                              ---







           GAAP Reported          $155,054              $87,690                        $8,223         $59,141            38%               $9,810                       $20,588                               $1,022                                       369,499                       $(341,778)                     $(21,350)                           $(363,128)                     $(75,600)                $(287,528)                    $(7.65)


                           Adjustments:

                                    ---

         Depreciation of
      Fixed Assets step-
                  up (a)                 -             (1,335)                                       1,335                                                                                                                                                                             1,335                                                               1,335                                                    1,335


         Amortization of
         intangibles (b)                 -                                          (8,223)          8,223                                                                                                                                                                             8,223                                                               8,223                                                    8,223


           Restructuring
            expenses (c)                 -                                                                                                                                                             (1,022)                                                                        1,022                                                               1,022                                                    1,022


        Asset impairment
             charges (d)                 -                                                                                                                                                                                                        (369,499)                         369,499                                                             369,499                                                  369,499


       Non-cash interest
                     (e)                 -                                                                                                                                                                                                                                                                          4,538                                 4,538                                                    4,538


               Other (f)                 -                                                                                                                         (1,340)                                                                                                            1,340                                                               1,340                                                    1,340


     Tax adjustments (g)                 -                                                                                                                                                                                                                                                                                                                                            81,504                   (81,504)




       Non-GAAP Adjusted          $155,054              $86,355   
              $              -        $68,699            44%               $9,810                       $19,248         
              $               -           
              $                     -                         $39,641                      $(16,812)                              $22,829                         $5,904                    $16,925                       $0.44




               (a)               Relates to
                                  depreciation of
                                  a fair value
                                  step-up in
                                  property, plant
                                  and equipment
                                  related to the
                                  acquisition of
                                  Kremers Urban
                                  Pharmaceuticals,
                                  Inc. ("KUPI")


               (b)               Relates to
                                  amortization of
                                  purchased
                                  intangible
                                  assets
                                  primarily
                                  related to the
                                  acquisitions of
                                  KUPI and Silarx
                                  Pharmaceuticals,
                                  Inc.


               (c)               To exclude
                                  expenses
                                  associated with
                                  the 2016
                                  Restructuring
                                  Plan and, to a
                                  lesser extent,
                                  the Cody
                                  Restructuring
                                  Plan


               (d)               To exclude asset
                                  impairment
                                  charges related
                                  to goodwill and
                                  other long-
                                  lived assets


               (e)               To exclude non-
                                  cash interest
                                  expense
                                  associated with
                                  debt issuance
                                  costs


               (f)               To primarily
                                  exclude
                                  depreciation on
                                  previously
                                  capitalized
                                  software
                                  integration
                                  costs
                                  associated with
                                  the KUPI
                                  acquisition


               (g)               The tax effect
                                  of the pre-tax
                                  adjustments
                                  included at
                                  applicable tax
                                  rates


               (h)               The weighted
                                  average share
                                  number for the
                                  three months
                                  ended September
                                  30, 2018 is
                                  37,586,327 for
                                  GAAP and
                                  38,752,010 for
                                  the non-GAAP
                                  earnings (loss)
                                  per share
                                  calculations

                                                                                                                                           
              
                LANNETT COMPANY, INC.


                                                                                                                   
             
              RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (UNAUDITED)


                                                                                                                                
            (In thousands, except percentages, share and per share data)




                                                                                                                                     
            
                Three months ended September 30, 2017

                                                                                                                                                                ---

                         
       Net sales     
           Cost of      
             Amortization        Gross Profit         Gross       
            R&D              
              SG&A              
              Acquisition and          
           Restructuring                  Operating         
             Other         
            
            Income        
             Income tax       
              
          Net                      Diluted
                                             sales                of intangibles                              Margin %          expense                   expense                         integration-                      expenses                      income                     income                        before                     expense                         income                   earnings
                                                                                                                                                                                             related                                                                                  (loss)                      income tax                                                                           per share
                                                                                                                                                                                             expenses                                                                                                                                                                                                     (g)

                                                                                                                                                                                                                                                                                                                                                                                                                     ---







           GAAP Reported          $154,961              $79,553                        $7,737         $67,671            44%                  $7,409                       $19,038                                    $18                            $527                  $40,679                      $(19,999)                     $20,680                          $7,423                  $13,257                      $0.35


                           Adjustments:

                                    ---

         Depreciation of
      Fixed Assets step-
                  up (a)                 -             (1,335)                                       1,335                                                                                                                                                            1,335                                                      1,335                                                   1,335


         Amortization of
         intangibles (b)                 -                                          (7,737)          7,737                                                               (365)                                                                                        8,102                                                      8,102                                                   8,102


         Acquisition and
            integration-
        related expenses
                     (c)                 -                                                                                                                                                                       (18)                                                   18                                                         18                                                      18


           Restructuring
            expenses (d)                 -                                                                                                                                                                                                     (527)                   527                                                        527                                                     527


       Non-cash interest
                     (e)                 -                                                                                                                                                                                                                                                         4,560                        4,560                                                   4,560


     Tax adjustments (f)                 -                                                                                                                                                                                                                                                                                                                    5,123                  (5,123)




       Non-GAAP Adjusted          $154,961              $78,218   
              $              -        $76,743            50%                  $7,409                       $18,673             
              $             -     
              $             -                 $50,661                      $(15,439)                     $35,222                         $12,546                  $22,676                      $0.60






               (a)               Relates to
                                  depreciation of
                                  a fair value
                                  step-up in
                                  property, plant
                                  and equipment
                                  related to the
                                  acquisition of
                                  Kremers Urban
                                  Pharmaceuticals,
                                  Inc. ("KUPI")


               (b)               Relates to
                                  amortization of
                                  purchased
                                  intangible
                                  assets
                                  primarily
                                  related to the
                                  acquisitions of
                                  KUPI and Silarx
                                  Pharmaceuticals,
                                  Inc.


               (c)               Relates to
                                  acquisition and
                                  integration-
                                  related
                                  expenses
                                  primarily
                                  related to the
                                  acquisition of
                                  KUPI


               (d)               To exclude
                                  expenses
                                  associated with
                                  the 2016
                                  Restructuring
                                  Plan


               (e)               To exclude non-
                                  cash interest
                                  expense
                                  primarily
                                  associated with
                                  debt issuance
                                  costs


               (f)               The tax effect
                                  of the pre-tax
                                  adjustments
                                  included at
                                  applicable tax
                                  rates


               (g)               The weighted
                                  average share
                                  number for the
                                  three months
                                  ended September
                                  30, 2017 is
                                  37,730,656 for
                                  both the GAAP
                                  and the non-
                                  GAAP earnings
                                  per share
                                  calculations

                                         
              
                LANNETT COMPANY, INC.


                             
       
            RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED INFORMATION (UNAUDITED)


                                                  
              ($ in millions)




                                              Fiscal Year 2019 Guidance



                                                                                                                               Non-GAAP


                                              GAAP                                         Adjustments                         Adjusted





     Net sales                 
           $585 - $615                                                                  
           $585 - $615


     Gross margin percentage         38.0% - 39.0%                                                 6%   
         (a)       44.0% to 45.0%


     R&D expense                 
           $32 - $36                                                ($2)   
         (b)    
           $30 - $34


     SG&A expense                
           $75 - $78                                               ($12)   
         (c)    
           $63 - $66


     Restructuring expense         
           $3 - $4                        
               ($3 - $4)          
         (d)


     Asset impairment charges                 $369                                               ($369)   
         (e)


     Interest expense            
           $81 - $83                                               ($18)   
         (f)    
           $63 - $65


     Effective tax rate                 22% to 23%                                                                          22% to 23%


     Capital expenditures        
           $30 - $35                                                                    
           $30 - $35







               (a) The adjustment primarily reflects
                amortization of purchased intangible
                assets related to the acquisition of
                Kremers Urban Pharmaceuticals, Inc.
                ("KUPI") and, to a lesser extent, the
                cost of sales associated with the Cody
                API business which is classified as Held
                For Sale as of September 30, 2018


               (b) To exclude R&D expense associated
                with the Cody API business which is
                classified as Held For Sale as of
                September 30, 2018


               (c) To exclude various expenses
                associated with the Company's overall
                cost savings initiatives, which includes
                the operating costs of the Cody API
                business subsequent to September 30,
                2018, the date it was classified as Held
                For Sale; legal and financial advisory
                costs; as well as nonrecurring
                compensation related expenses. In
                addition, it also excludes depreciation
                on previously capitalized software
                integration costs associated with the
                KUPI acquisition


               (d) To exclude expenses associated with
                the 2016 Restructuring Plan and Cody
                Restructuring Plan


               (e) To exclude asset impairment charges
                related to goodwill and other long-
                lived assets


               (f) The adjustment primarily reflects
                non-cash interest expense associated
                with debt issuance costs

                 
              
              LANNETT COMPANY, INC.


            
              
              NET SALES BY MEDICAL INDICATION




                                                                   Three months ended


        (in thousands)                                             September 30,



                                  Medical Indication         2018     2017

    ---


       Antibiotic                                         $4,089   $3,349


        Anti-Psychosis                                     10,889   14,991


        Cardiovascular                                     21,770   11,306


        Central Nervous System                              7,197    8,818



       Gallstone                                           2,214    6,564


        Gastrointestinal                                   15,040   14,553



       Glaucoma                                              548    2,668



       Migraine                                            9,737   15,015


        Muscle Relaxant                                     3,179    3,791


        Pain Management                                     4,947    5,761



       Respiratory                                         1,015    1,647


        Thyroid Deficiency                                 53,878   47,214



       Urinary                                             1,552    2,997



       Other                                              14,338   12,696


        Contract manufacturing
         revenue                                            4,661    3,591



                        Net Sales                        $155,054 $154,961





              Contact:                   Robert Jaffe


                                          Robert Jaffe Co.,
                                           LLC


                                          (424) 288-4098

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SOURCE Lannett Company, Inc.