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AMPH - Amphastar Pharmaceuticals Inc News Story

$20.17 -0.2  -1.1%

Last Trade - 18/06/21

Sector
Healthcare
Size
Mid Cap
Market Cap £695.8m
Enterprise Value £677.5m
Revenue £266.6m
Position in Universe 2961st / 6927

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2021

Thu 6th May, 2021 9:05pm
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Reports Net Revenues of $103.0 Million for the Three Months Ended March 31,
2021

RANCHO CUCAMONGA, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Amphastar
Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”)
today reported results for the three months ended March 31, 2021.

First Quarter Highlights
* Net revenues of $103.0 million for the first quarter
* GAAP net income of $5.0 million, or $0.10 per share, for the first quarter
* Adjusted non-GAAP net income of $13.6 million, or $0.27 per share, for the
first quarter
Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer commented:
“The launch of glucagon, along with strong sales growth of Primatene
Mist(®) and our epinephrine products, contributed to one of Amphastar’s
strongest quarters in terms of sales growth to date. We expect that these core
growth products will continue to drive growth for the remainder of the year,
while we are confident in seeing our pipeline develop to diversify our
portfolio.”

                                                                                                                            
                                                                          Three Months Ended                                
                                                                          March 31,                                         
                                                                          2021                          2020                
                                                                                                                            
                                                                          (in thousands, except per share data)             
 Net revenues                                                             $         103,020             $         84,688    
 GAAP net income attributable to Amphastar                                $         5,041               $         3,949     
 Adjusted non-GAAP net income attributable to Amphastar*                  $         13,553              $         8,383     
 GAAP diluted EPS attributable to Amphastar stockholders                  $         0.10                $         0.08      
 Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders*    $         0.27                $         0.17      

_______________
 (* Adjusted non-GAAP net income and Adjusted non-GAAP diluted EPS are
non-GAAP financial measures. Please see the discussion in the section entitled
“Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP
financial measures in Table III of this press release.)

First Quarter Results

                                                                                                                                 
                                                        Three Months Ended                                                       
                                                        March 31,                              Change                            
                                                        2021                 2020              Dollars               %           
                                                                                                                                 
                                                        (in thousands)                                                           
 Net revenues:                                                                                                                   
 Primatene Mist (®)                                     $     18,383         $     12,877      $    5,506            43       %  
 Epinephrine                                                  15,578               3,990            11,588           290      %  
 Enoxaparin                                                   10,658               9,168            1,490            16       %  
 Phytonadione                                                 9,565                11,029           (1,464  )        (13  )   %  
 Lidocaine                                                    9,071                10,657           (1,586  )        (15  )   %  
 Glucagon                                                     7,984                —                7,984            N/A         
 Naloxone                                                     6,341                8,875            (2,534  )        (29  )   %  
 Other finished pharmaceutical products                       20,302               24,702           (4,400  )        (18  )   %  
 Total finished pharmaceutical products net revenues    $     97,882         $     81,298      $    16,584           20       %  
 API                                                          5,138                3,390            1,748            52       %  
 Total net revenues                                     $     103,020        $     84,688      $    18,332           22       %  

Changes in net revenues were primarily driven by:
* Primatene Mist(®) increased volumes resulting from: * The continued success
of our nationwide television, radio, and digital marketing campaign
* An increase in our distribution channels throughout 2020 and during the
first quarter of 2021, including Target, which began selling Primatene
Mist(®) in March 2021
 
* Glucagon for injection emergency kit launched in February 2021
* Epinephrine sales increased due to the launch of our approved epinephrine
injection multi-dose vials during the second quarter of 2020 and a market
shortage of the pre-filled syringes
* Naloxone sales decreased due to lower average selling price because of
increased competition
* Other finished pharmaceutical product sales decreased due to lower demand,
largely due to competitors returning to their normal distribution levels
                                                                                                
                         Three Months Ended                                                     
                         March 31,                                     Change                   
                         2021                    2020                  Dollars           %      
                                                                                                
                         (in thousands)                                                         
 Net revenues            $    103,020            $    84,688           $     18,332      22  %  
 Cost of revenues             58,074                  47,865                 10,209      21  %  
 Gross profit            $    44,946             $    36,823           $     8,123       22  %  
 as % of net revenues         44 %                    43 %                                      

Changes in the cost of revenues and the resulting increase in gross margin
were primarily driven by:
* Increased sales of higher margin products such as Primatene Mist(®),
epinephrine injection multi-dose vials, and glucagon
* Partially offset by increased sales of low margin enoxaparin and higher
input cost
                                                                                                                      
                                         Three Months Ended                                                           
                                         March 31,                                    Change                          
                                         2021                   2020                  Dollars              %          
                                                                                                                      
                                         (in thousands)                                                               
 Selling, distribution, and marketing    $    4,537             $    3,294            $    1,243           38      %  
 General and administrative                   15,338                 10,746                4,592           43      %  
 Research and development                     14,765                 15,303                (538   )        (4  )   %  
 Non-operating expense, net                   5,192                  1,675                 3,517           NM         
* Selling, distribution, and marketing expenses increased due to the cost of
our ongoing national television, radio, and digital marketing campaign for
Primatene Mist(®)
* General and administrative expenses increased primarily due to increased
legal expenses, including a reserve of $1.3 million related to the settlement
of employment litigation
* Research and development expenses decreased due to lower clinical trial
expenses, which was partially offset by an increase in salaries and
personnel-related expenses as well as an increase in depreciation expense
* We recorded an additional $4.4 million of expense relating to the litigation
with Aventis
Cash flow provided by operating activities for the three months ended March
31, 2021, was $22.8 million.

Pipeline Information

The Company currently has five ANDAs on file with the FDA targeting products
with a market size of approximately $2.4 billion, three biosimilar products in
development targeting products with a market size of approximately $13
billion, and seven generic products in development targeting products with a
market size of approximately $10 billion. This market information is based on
IQVIA data for the 12 months ended March 31, 2021. The Company is currently
developing multiple proprietary products with injectable and intranasal dosage
forms.

Amphastar’s Chinese subsidiary, ANP, currently has 17 Drug Master Files, or
DMFs, on file with the FDA and is developing several additional DMFs.

Company Information

Amphastar is a bio-pharmaceutical company that focuses primarily on
developing, manufacturing, marketing, and selling technically-challenging
generic and proprietary injectable, inhalation, and intranasal products.
Additionally, the Company sells insulin API products. Most of the Company’s
finished products are used in hospital or urgent care clinical settings and
are primarily contracted and distributed through group purchasing
organizations and drug wholesalers. More information and resources are
available at www.amphastar.com.

Amphastar’s logo and other trademarks or service marks of Amphastar,
including, but not limited to Amphastar(®), Primatene Mist(®),
Amphadase(®), and Cortrosyn(®), are the property of Amphastar.

Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and
presented in accordance with U.S. generally accepted accounting principles
(“GAAP”), the Company is disclosing non-GAAP financial measures when
providing financial results. The Company believes that an evaluation of its
ongoing operations (and comparisons of its current operations with historical
and future operations) would be difficult if the disclosure of its financial
results were limited to financial measures prepared only in accordance with
GAAP. As a result, the Company is disclosing certain non-GAAP results,
including (i) Adjusted non-GAAP net income (loss) attributed to Amphastar and
(ii) Adjusted non-GAAP diluted EPS attributed to Amphastar’s stockholders,
which exclude amortization expense, share-based compensation, impairment
charges, executive severance expense, and legal settlements, in order to
supplement investors’ and other readers’ understanding and assessment of
the Company’s financial performance because the Company’s management uses
these measures internally for forecasting, budgeting, and measuring its
operating performance. Whenever the Company uses such non-GAAP measures, it
will provide a reconciliation of non-GAAP financial measures to their most
directly comparable GAAP financial measures. Investors and other readers are
encouraged to review the related GAAP financial measures and the
reconciliation of non-GAAP measures to their most directly comparable GAAP
measures set forth below and should consider non-GAAP measures only as a
supplement to, not as a substitute for or as a superior measure to, measures
of financial performance prepared in accordance with GAAP.

Conference Call Information

The Company will hold a conference call to discuss its financial results
today, May 6, 2021, at 2:00 p.m. Pacific Time.

To access the conference call, dial toll-free (877) 876-9177 or (785) 424-1672
for international callers, five minutes before the conference.

The call can also be accessed on the Investors page on the Company’s website
www.amphastar.com.

Forward Looking Statements

All statements in this press release and in the conference call referenced
above that are not historical are forward-looking statements, including, among
other things, statements relating to our expectations regarding future
financial performance, backlog, sales and marketing of our products, market
size and growth, product development, the timing of FDA filings or approvals,
including the DMFs of ANP, the timing of product launches, acquisitions and
other matters related to our pipeline of product candidates, our share buyback
program and other future events, such as the impact of the COVID-19 pandemic
and related responses of business and governments to the pandemic on our
operations and personnel, and on commercial activity and demand across our
business operations and results of operations. These statements are not facts
but rather are based on Amphastar’s historical performance and our current
expectations, estimates, and projections regarding our business, operations,
and other similar or related factors. Words such as “may,” “might,”
“will,” “could,” “would,” “should,” “anticipate,”
“predict,” “potential,” “continue,” “expect,” “intend,”
“plan,” “project,” “believe,” “estimate,” and other similar or
related expressions are used to identify these forward-looking statements,
although not all forward-looking statements contain these words. You should
not place undue reliance on forward-looking statements because they involve
known and unknown risks, uncertainties, and assumptions that are difficult or
impossible to predict and, in some cases, beyond Amphastar’s control. Actual
results may differ materially from those in the forward-looking statements as
a result of a number of factors, including those described in Amphastar’s
filings with the Securities and Exchange Commission, including in our Annual
Report on Form 10-K for the year ended December 31, 2020, filed with the SEC
on March 15, 2021. In particular, the extent of COVID-19’s impact on our
business will depend on several factors, including the severity, duration and
extent of the pandemic, as well as actions taken by governments, businesses,
and consumers in response to the pandemic, all of which continue to evolve and
remain uncertain at this time. You can locate these reports through our
website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov.
The forward-looking statements in this release speak only as of the date of
the release. Amphastar undertakes no obligation to revise or update
information or any forward-looking statements in this press release or the
conference call referenced above to reflect events or circumstances in the
future, even if new information becomes available or if subsequent events
cause our expectations to change.

Contact Information:

Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484

Table I
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations
(Unaudited; in thousands, except per share data)

                                                                                                                                                   
                                                                                                         Three Months Ended                        
                                                                                                         March 31,                                 
                                                                                                         2021                    2020              
                                                                                                                                                   
 Net revenues                                                                                            $    103,020            $    84,688       
 Cost of revenues                                                                                             58,074                  47,865       
 Gross profit                                                                                                 44,946                  36,823       
                                                                                                                                                   
 Operating expenses:                                                                                                                               
 Selling, distribution, and marketing                                                                         4,537                   3,294        
 General and administrative                                                                                   15,338                  10,746       
 Research and development                                                                                     14,765                  15,303       
 Total operating expenses                                                                                     34,640                  29,343       
                                                                                                                                                   
 Income from operations                                                                                       10,306                  7,480        
                                                                                                                                                   
 Non-operating expense, net                                                                                   (5,192   )              (1,675  )    
                                                                                                                                                   
 Income before income taxes                                                                                   5,114                   5,805        
 Income tax provision                                                                                         1,155                   2,280        
                                                                                                                                                   
 Net income                                                                                              $    3,959              $    3,525        
                                                                                                                                                   
 Net loss attributable to non-controlling interests                                                      $    (1,082   )         $    (424    )    
                                                                                                                                                   
 Net income attributable to Amphastar                                                                    $    5,041              $    3,949        
                                                                                                                                                   
 Net income per share attributable to Amphastar stockholders:                                                                                      
 Basic                                                                                                   $    0.11               $    0.09         
 Diluted                                                                                                 $    0.10               $    0.08         
                                                                                                                                                   
 Weighted-average shares used to compute net income per share attributable to Amphastar stockholders:                                              
 Basic                                                                                                        47,520                  46,408       
 Diluted                                                                                                      49,518                  48,248       

Table II
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet
(Unaudited; in thousands, except per share data)

                                                                                                                                                                                                                                                                                                   
                                                                                                                                                                                                                                                   March 31,               December 31,            
                                                                                                                                                                                                                                                   2021                    2020                    
 ASSETS                                                                                                                                                                                                                                                                                            
 Current assets:                                                                                                                                                                                                                                                                                   
 Cash and cash equivalents                                                                                                                                                                                                                         $     101,601           $      92,642           
 Restricted cash                                                                                                                                                                                                                                         235                      1,865            
 Short-term investments                                                                                                                                                                                                                                  13,531                   12,977           
 Restricted short-term investments                                                                                                                                                                                                                       2,200                    2,200            
 Accounts receivable, net                                                                                                                                                                                                                                77,938                   66,005           
 Inventories                                                                                                                                                                                                                                             97,110                   96,831           
 Income tax refunds and deposits                                                                                                                                                                                                                         800                      385              
 Prepaid expenses and other assets                                                                                                                                                                                                                       6,749                    6,777            
 Total current assets                                                                                                                                                                                                                                    300,164                  279,682          
                                                                                                                                                                                                                                                                                                   
 Property, plant, and equipment, net                                                                                                                                                                                                                     253,265                  260,055          
 Finance lease right-of-use assets                                                                                                                                                                                                                       594                      612              
 Operating lease right-of-use assets                                                                                                                                                                                                                     19,280                   20,042           
 Goodwill and intangible assets, net                                                                                                                                                                                                                     40,243                   40,615           
 Other assets                                                                                                                                                                                                                                            7,212                    5,250            
 Deferred tax assets                                                                                                                                                                                                                                     24,980                   24,980           
 Total assets                                                                                                                                                                                                                                      $     645,738           $      631,236          
                                                                                                                                                                                                                                                                                                   
 LIABILITIES AND STOCKHOLDERS' EQUITY                                                                                                                                                                                                                                                              
 Current liabilities:                                                                                                                                                                                                                                                                              
 Accounts payable and accrued liabilities                                                                                                                                                                                                          $     108,545           $      95,504           
 Income taxes payable                                                                                                                                                                                                                                    2,676                    1,077            
 Current portion of long-term debt                                                                                                                                                                                                                       12,173                   12,263           
 Current portion of operating lease liabilities                                                                                                                                                                                                          3,702                    3,357            
 Total current liabilities                                                                                                                                                                                                                               127,096                  112,201          
                                                                                                                                                                                                                                                                                                   
 Long-term reserve for income tax liabilities                                                                                                                                                                                                            4,709                    4,709            
 Long-term debt, net of current portion                                                                                                                                                                                                                  32,334                   34,186           
 Long-term operating lease liabilities, net of current portion                                                                                                                                                                                           16,464                   17,464           
 Deferred tax liabilities                                                                                                                                                                                                                                755                      741              
 Other long-term liabilities                                                                                                                                                                                                                             13,420                   13,212           
 Total liabilities                                                                                                                                                                                                                                       194,778                  182,513          
 Commitments and contingencies                                                                                                                                                                                                                                                                     
 Stockholders’ equity:                                                                                                                                                                                                                                                                             
 Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding                                                                                                                                                      —                        —                
 Common stock: par value $0.0001; 300,000,000 shares authorized; 55,184,000 and 47,718,003 shares issued and outstanding as of March 31, 2021 and 54,760,922 and 47,495,439 shares issued and outstanding as of December 31, 2020, respectively          6                        5                
 Additional paid-in capital                                                                                                                                                                                                                              413,926                  410,061          
 Retained earnings                                                                                                                                                                                                                                       122,814                  117,773          
 Accumulated other comprehensive loss                                                                                                                                                                                                                    (5,642    )              (3,721    )      
 Treasury stock                                                                                                                                                                                                                                          (125,546  )              (121,812  )      
 Total Amphastar Pharmaceuticals, Inc. stockholders’ equity                                                                                                                                                                                              405,558                  402,306          
 Non-controlling interests                                                                                                                                                                                                                               45,402                   46,417           
 Total equity                                                                                                                                                                                                                                            450,960                  448,723          
 Total liabilities and stockholders’ equity                                                                                                                                                                                                        $     645,738           $      631,236          

Table III
Amphastar Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)

                                                                                                                                                         
                                                                                                                Three Months Ended                       
                                                                                                                March 31,                                
                                                                                                                2021                   2020              
                                                                                                                                                         
 GAAP net income                                                                                                $    3,959             $    3,525        
 Adjusted for:                                                                                                                                           
 Intangible amortization                                                                                             276                    258          
 Share-based compensation                                                                                            4,834                  5,282        
 Impairment of long-lived assets                                                                                     6                      14           
 Reserves for litigation and settlements                                                                             5,695                  —            
 Income tax (benefit) provision on pre-tax adjustments                                                               (2,229  )              (1,004  )    
 Non-GAAP net income                                                                                            $    12,541            $    8,075        
                                                                                                                                                         
 Non-GAAP net loss attributable to non-controlling interests                                                    $    (1,012  )         $    (308    )    
                                                                                                                                                         
 Non-GAAP net income attributable to Amphastar                                                                  $    13,553            $    8,383        
                                                                                                                                                         
 Non-GAAP net income per share attributable to Amphastar stockholders:                                                                                   
 Basic                                                                                                          $    0.29              $    0.18         
 Diluted                                                                                                        $    0.27              $    0.17         
                                                                                                                                                         
 Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders:                                           
 Basic                                                                                                               47,520                 46,408       
 Diluted                                                                                                             49,518                 48,248       



                                                                                                                                                                                                                                   
                                                          Three Months Ended March 31, 2021                                                                                                                                        
                                                                                                                                                                                                                                   
                                                                                Selling,                 General                   Research                                          Income                Non-controlling         
                                                          Cost of               distribution             and                       and                     Non-operating             tax provision         interest                
                                                          revenue               and marketing            administrative            development             expense, net              (benefit)             adjustment              
 GAAP                                                     $    58,074           $      4,537             $      15,338             $     14,765            $      5,192              $        1,155        $       (1,082  )       
 Intangible amortization                                       (242    )               —                        (34     )                —                        —                           —                    11              
 Share-based compensation                                      (1,146  )               (127   )                 (2,968  )                (593    )                —                           —                    71              
 Impairment of long-lived assets                               —                       —                        (6      )                —                        —                           —                    2               
 Reserves for litigation and settlements                       —                       —                        (1,295  )                —                        (4,400  )                   —                    —               
 Income tax provision (benefit) on pre-tax adjustments         —                       —                        —                        —                        —                           2,229                (14     )       
 Non-GAAP                                                 $    56,686           $      4,410             $      11,035             $     14,172            $      792                $        3,384        $       (1,012  )       



                                                                                                                                                                                                                                  
                                                          Three Months Ended March 31, 2020                                                                                                                                       
                                                                                                                                                                                                                                  
                                                                                Selling,                 General                   Research                                         Income                Non-controlling         
                                                          Cost of               distribution             and                       and                     Non-operating            tax provision         interest                
                                                          revenue               and marketing            administrative            development             expense, net             (benefit)             adjustment              
 GAAP                                                     $    47,865           $      3,294             $      10,746             $     15,303            $      1,675             $        2,280        $       (424    )       
 Intangible amortization                                       (224    )               —                        (34     )                —                        —                          —                    11              
 Share-based compensation                                      (1,359  )               (107   )                 (3,219  )                (597    )                —                          —                    127             
 Impairment of long-lived assets                               (10     )               —                        (4      )                —                        —                          —                    1               
 Income tax provision (benefit) on pre-tax adjustments         —                       —                        —                        —                        —                          1,004                (23     )       
 Non-GAAP                                                 $    46,272           $      3,187             $      7,489              $     14,706            $      1,675             $        3,284        $       (308    )       



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