-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SWAyKyO4jZ73k9U8w9KEx1XiyolblumOlL4GI7vdtqyB7/dwto7cS5l48jmRLHrF WgkR6uDuha+AbcTAnRTPdA== 0000950124-08-001166.txt : 20080312 0000950124-08-001166.hdr.sgml : 20080312 20080312060507 ACCESSION NUMBER: 0000950124-08-001166 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080311 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080312 DATE AS OF CHANGE: 20080312 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AKORN INC CENTRAL INDEX KEY: 0000003116 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 720717400 STATE OF INCORPORATION: LA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32360 FILM NUMBER: 08682290 BUSINESS ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 8-K 1 c24785e8vk.htm CURRENT REPORT e8vk
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report: March 11, 2008
(Date of earliest event reported)
Akorn, Inc.
(Exact name of registrant as specified in its charter)
         
Louisiana
(State or other
jurisdiction of
incorporation)
  001-32360
(Commission
File Number)
  72-0717400
(I.R.S. Employer
Identification No.)
2500 MILLBROOK DRIVE
BUFFALO GROVE, ILLINOIS 60089

(Address of principal executive offices, zip code)
(847) 279-6100
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240. 13e-4(c))
 
 

 


 

Item 2.02 Results of Operations and Financial Condition.
     On March 11, 2008, Akorn, Inc. (“Akorn”) issued a press release announcing certain results of Akorn’s financial review for the quarter and year ended December 31, 2007. A copy of the press release is attached hereto as Exhibit 99.1.
Item 7.01 Regulation FD Disclosure.
     On March 11, 2008, Arthur S. Przybyl, President and Chief Executive Officer of Akorn, and Jeffrey A. Whitnell, Chief Financial Officer of Akorn, held a conference call with investors. The scripts for this call for Mr. Przybyl and Mr. Whitnell are attached hereto as Exhibits 99.2 and 99.3, respectively.
     The information in each item of this report, including the exhibits hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
     We expressly disclaim any obligation to update these exhibits and caution that they are only accurate on the date they were presented. The inclusion of any data or statements in these exhibits does not signify that the information is considered material.
Item 9.01 Financial Statements and Exhibits.
     (d) Exhibits.
     
99.1
  Press release dated March 11, 2008.
 
   
99.2
  Script of Mr. Przybyl for March 11, 2008 conference call.
 
   
99.3
  Script of Mr. Whitnell for March 11, 2008 conference call.

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  Akorn, Inc.
 
 
 
  By:   /s/ Jeffrey A. Whitnell    
    Jeffrey A. Whitnell   
    Chief Financial Officer, Treasurer
and Secretary 
 
 
Date: March 11, 2008

 

EX-99.1 2 c24785exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
At the Company:
Akorn, Inc.
Arthur S. Przybyl, President and CEO
Jeffrey A. Whitnell, CFO
(847) 279-6100
FOR IMMEDIATE RELEASE
Akorn Reports Fourth Quarter and Full Year 2007
Financial Results; Provides 2008 Outlook
Buffalo Grove, IL, March 11, 2008 — Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported financial results for the fourth quarter and full year ended December 31, 2007.
Total revenue for the fourth quarter 2007 was $13.7 million, versus $14.6 million in the fourth quarter 2006. The year-over-year decline is principally due to the lack of DTPA revenue in this year’s fourth quarter results. During the fourth quarter 2007, Ophthalmic and Hospital Drugs and Injectables business segment revenues (excluding DTPA) increased by approximately 40% and 11% respectively, versus the prior year comparative period. The Company recorded DTPA product revenues of $3.6 million in the fourth quarter 2006 and negligible DTPA product revenue in the fourth quarter 2007. The Company also recorded Vaccine revenues of approximately $2.8 million in the fourth quarter 2007. Contract Services business segment revenues declined $1.9 million versus the comparative prior year quarter.
In the fourth quarter 2007, the Company announced the successful results of the FDA inspection for the Decatur, IL facility. The satisfactory resolution of past cGMP issues and a successful pre-approval inspection of the lyophilization facility are both significant events. Further, regulatory compliance in Decatur is anticipated to strengthen the Contract Services business segment in 2008.
Total revenue for 2007 was $52.9 million versus $71.3 million in 2006. Excluding DTPA product revenues, total revenues for 2007 increased approximately 11.6% versus 2006. Ophthalmic business segment revenues decreased by approximately 5%, due to deferred customer shipments resulting from the site transfer of IC-Green. Hospital Drugs and Injectables business segment revenues (excluding DTPA) increased by approximately 4%, led by greater hospital contract compliancy. Vaccine revenues totaled $7.5 million, beginning with our September 2007 launch of the Tetanus Diphtheria vaccine. Contract Services business segment revenues declined by approximately 20%, primarily due to customer concerns regarding regulatory compliance issues in our Decatur facility in 2007.

 


 

Gross profit for the fourth quarter 2007 was $3.1 million as compared to $4.2 million in the fourth quarter 2006. The aggregate decline in fourth quarter 2007 gross profit versus the comparative prior year period was due to product mix and the prior year DTPA order. Sequentially, fourth quarter 2007 gross margin improved to 22.3% versus the third quarter 2007 gross margin of 18.8%. Lower Contract Services business segment volumes resulted in under absorbed manufacturing costs at our Decatur, IL production facility. Consequently, the Company has completed a reorganization that will generate projected annual cost savings of approximately $2.0 million.
Selling, general and administrative expenses totaled $6.1 million in the fourth quarter 2007, an increase of $0.8 million over the comparative prior year period. This increase is due to the investment in our newly created Vaccine Sales Team of twenty sales representatives, bringing the total Field and Inside Sales Representatives at the Company to 50. Research and development expenses were $1.5 million in the fourth quarter 2007 versus $5.0 million in the comparative prior year period, and reflect lower milestone payments for product development efforts.
The net loss available to common stockholders for the fourth quarter 2007 was $5.0 million or $0.06 per fully diluted share vs. the net loss available to common stockholders of $6.2 million in the fourth quarter 2006 or $0.07 per fully diluted share. As of December 31, 2007, the Company had cash and cash equivalents equal to $7.9 million and $10.5 million of undrawn availability under our Credit Agreement.
The assets on our balance sheet have increased year over year, by approximately 6% in 2007, a reflection of multi-dose Tetanus Diphtheria vaccine and the corresponding inventory position. Today, Akorn is the only MDV supplier of Td-Vaccines in the marketplace with product dating greater than 12 months, and we look forward to servicing this important market through 2009. At that time, the supply of MDV will be exhausted in the marketplace and we will have transitioned our customers to the UDPF vaccine, primarily in the office-based physician market.
Company Highlights:
  Biologics and Vaccines Business Segment:
    February 21, 2008: Akorn announced the signing of a Specialty Distributor Agreement with CSL Biotherapies for Afluria® (Flu Vaccine).
 
    November 26, 2007: On behalf of our vaccine manufacturer, Akorn announced FDA approval for the unit dose preservative-free Tetanus Diphtheria vaccine.

 


 

Company Highlights (cont.):
    October 29, 2007: Akorn announced the signing of an exclusive Vaccine partnership agreement to commercialize four vaccine products for the U.S. market, and the sale of one million shares of common stock to Serum Institute of India, Ltd.
  Hospital Drugs and Injectables Business Segment:
    January 30, 2008: Akorn announced FDA approval of Calcitriol Injection, 1 mcg/mL and 2 mcg/mL.
 
    December 5, 2007: Akorn announced the first ANDA submission for a generic anti-cancer injectable product as part of an exclusive drug development and distribution agreement for oncology and other Injectable products announced on October 15, 2004 with Serum Institute of India, Ltd.
 
    November 27, 2007: Akorn announced the signing of an exclusive manufacturing and supply agreement with Cipla, Ltd. for an inhalation drug product.
 
    October 11, 2007: Akorn announced the signing of an exclusive licensing, development and supply agreement with Sofgen Pharmaceuticals for an ANDA oral drug product for women’s healthcare.
  Contract Service Business Segment:
    February 14, 2008: Akorn announced the signing of a manufacturing and supply agreement at its Somerset, NJ facility for the contract manufacture of an ophthalmic solution.
  Corporate:
    December 21, 2007: Akorn announced FDA inspection results of the Decatur, IL facility: satisfactory resolution of past cGMP issues and a successful pre-approval inspection of the lyophilization facility.

 


 

Company Highlights (cont.):
    October 25, 2007: Akorn announced the signing of a ten-year lease for a state-of-the art Center for Excellence, a centralized facility dedicated to new product development activities.
Arthur S. Przybyl, President and Chief Executive Officer stated, “In 2007, we advanced our specialty pharmaceutical business in several areas with significant emphasis in vaccines and even greater emphasis on events that will lead to increased revenues in 2008. Our four distinct business segments each have a significant catalyst and opportunity that can provide incremental revenue growth in 2008:
    In the Vaccine business segment, full year Tetanus Diphtheria revenues and the recent launch of Affluria® (flu vaccine).
 
    In the Hospital Drugs and Injectables business segment, the pending approval and launch of oral Vancomycin, and the potential forward deployment of DTPA with the Department of HHS.
 
    In the Ophthalmic business segment, the launch of our internally developed NDA drug product, Akten®.
 
    In the Contract Services business segment, our ability to expand our business into lyophilized contract pharmaceutical manufacturing.
These short term revenue opportunities are unique and diversified, and I am excited that our business franchise includes a significant number of opportunities to draw upon and execute against. I will further expand upon these opportunities in our conference call this afternoon.”

 


 

About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company’s website at www.akorn.com.
Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.
Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled “Cautionary Statement Regarding Forward-Looking Statements” in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.

 


 

AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS
                 
    DECEMBER 31,     DECEMBER 31,  
    2007     2006  
    (AUDITED)     (AUDITED)  
ASSETS
               
CURRENT ASSETS
               
Cash and cash equivalents
  $ 7,948     $ 21,818  
Restricted cash for Revolving Credit Agreement
    1,250        
Trade accounts receivable (less allowance for doubtful accounts of $5 and $3, respectively)
    4,112       4,781  
Inventories
    31,095       11,734  
Prepaid expenses and other current assets
    1,317       1,321  
 
           
TOTAL CURRENT ASSETS
    45,722       39,654  
PROPERTY, PLANT AND EQUIPMENT, NET
    32,262       33,486  
OTHER LONG-TERM ASSETS
               
Intangibles, net
    7,721       8,825  
Other
    1,261       118  
 
           
TOTAL OTHER LONG-TERM ASSETS
    8,982       8,943  
 
           
TOTAL ASSETS
  $ 86,966     $ 82,083  
 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
CURRENT LIABILITIES
               
Revolving line of credit
  $ 4,521     $  
Mortgage payable
    208       394  
Trade accounts payable
    14,070       4,719  
Accrued compensation
    895       1,849  
Accrued royalty
    12       1,517  
Accrued expenses and other liabilities
    1,294       1,774  
 
           
TOTAL CURRENT LIABILITIES
    21,000       10,253  
LONG-TERM LIABILITIES
               
Long-term debt, less current installments
          208  
Product warranty
    1,308       1,308  
 
           
TOTAL LONG-TERM LIABILITIES
    1,308       1,516  
 
           
TOTAL LIABILITIES
    22,308       11,769  
 
           
SHAREHOLDERS’ EQUITY
               
Common stock, no par value — 150,000,000 shares authorized; 88,900,588 and 85,990,964 shares issued and outstanding at December 31, 2007 and December 31, 2006, respectively
    165,829       150,250  
Warrants to acquire common stock
    2,795       4,862  
Accumulated deficit
    (103,966 )     (84,798 )
 
           
TOTAL SHAREHOLDERS’EQUITY
    64,658       70,314  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’EQUITY
  $ 86,966     $ 82,083  
 
           


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(AUDITED)
                                 
    THREE MONTHS ENDED
DECEMBER 31,
    TWELVE MONTHS ENDED
DECEMBER 31
 
    2007     2006     2007     2006  
Revenues
  $ 13,708     $ 14,555     $ 52,895     $ 71,250  
Cost of sales
    10,651       10,314       41,495       44,370  
                         
GROSS PROFIT
    3,057       4,241       11,400       26,880  
Selling, general and administrative expenses
    6,068       5,224       21,861       18,603  
Amortization and write-down of intangibles
    489       339       1,504       1,385  
Research and development expenses
    1,543       4,982       7,850       11,797  
                         
TOTAL OPERATING EXPENSES
    8,100       10,545       31,215       31,785  
                         
OPERATING (LOSS)/INCOME
    (5,043 )     (6,304 )     (19,815 )     (4,905 )
Interest Income/(Expense) — net
    81       251       649       (604 )
Debt Retirement Expense
                      (391 )
Other Income/(Expense)
        (3     1       (60
                         
(LOSS)/INCOME BEFORE INCOME TAXES
    (4,962     (6,056 )     (19,165 )     (5,960 )
Income tax provision
    2       3       3       3  
                         
NET (LOSS)/INCOME
    (4,964     (6,059 )     (19,168 )     (5,963 )
Preferred stock dividends and adjustments
          (101 )           (843 )
                         
NET (LOSS)/INCOME AVAILABLE TO COMMON STOCKHOLDERS
  $ (4,964 )   $ (6,160 )   $ (19,168 )   $ (6,806 )
                         
NET (LOSS)/INCOME PER SHARE:
                               
BASIC
  $ (0.06 )   $ (0.07 )   $ (0.22 )   $ (0.09 )
                         
DILUTED
  $ (0.06 )   $ (0.07 )   $ (0.22 )   $ (0.09 )
                         
SHARES USED IN COMPUTING NET (LOSS)/INCOME PER SHARE:
                               
BASIC
    88,235       82,548       87,286       73,988  
                         
DILUTED
    88,235       82,548       87,286       73,988  
                         


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(AUDITED)
                 
    TWELVE MONTHS  
    ENDED DECEMBER 31  
    2007     2006  
 
               
OPERATING ACTIVITIES
               
Net (loss)/income
  $ (19,168 )   $ (5,963 )
Adjustments to reconcile net (loss)/income to net cash (used in)/provided by operating activities
               
Depreciation and amortization
    4,512       3,372  
Amortization of debt discounts
          1,059  
Non-cash stock compensation expense
    3,184       1,948  
Changes in operating assets and liabilities:
               
Trade accounts receivable
    669       (1,559 )
Inventories
    (19,361 )     (1,455 )
Prepaid expenses and other current assets
    1,139       81  
Trade accounts payable
    9,351       1,673  
Product warranty
          1,308  
Royalty liability
    (1,505 )     1,517  
Accrued expenses and other liabilities
    (1,434 )     528  
 
           
NET CASH (USED IN)/PROVIDED BY OPERATING ACTIVITIES
    (24,891 )     2,509  
INVESTING ACTIVITIES
               
Purchases of property, plant and equipment
    (1,784 )     4,377  
Purchase of intangible assets
    (400 )      
 
           
NET CASH USED IN INVESTING ACTIVITIES
    (2,184 )     (4,377 )
FINANCING ACTIVITIES (See Note 1 below)
               
Repayment of long-term debt
    (394 )     (3,103 )
Restricted cash for Revolving Credit Agreement
    (1,250 )      
Proceeds from line of credit
    4,521        
Proceeds from common stock and warrant offering
    6,994       21,621  
Proceeds from warrants exercised
    2,507       2,848  
Proceeds under stock option and stock purchase plans
    827       1,529  
 
           
NET CASH PROVIDED BY FINANCING ACTIVITIES
    13,205       22,895  
(DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS
    (13,870 )     21,027  
Cash and cash equivalents at beginning of period
    21,818       791  
 
           
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 7,948     $ 21,818  
 
           
Amount paid for interest
  $ 72     $ 593  
Amount paid for income taxes
  $ 5     $ 2  
Note 1: In March 2006, $7,298 in principal and interest related to convertible notes was retired by conversion to the common stock of Akorn, Inc.

EX-99.2 3 c24785exv99w2.htm SCRIPT OF CONFERENCE CALL exv99w2
 

Exhibit 99.2
Good afternoon, ladies and gentlemen, and welcome to Akorn’s conference call. My name is Art Przybyl and presenting our financial position today is Jeff Whitnell, our CFO. We will hold a brief Q & A period at the end of the presentation.
I would like to begin with a brief recap of 2007 and then provide you with our outlook for 2008. Although we have historically not provided guidance, I believe from this 2008 outlook you will be able to understand our several significant 2008 revenue opportunities and catalysts, their market sizes and how they relate to what we believe is a robust business model for Akorn in 2008 and beyond.
In 2007, we advanced out specialty pharma business in several areas with significant emphasis in vaccines and with even greater emphasis placed on events that will lead to increased revenues in the short term, namely 2008. Our business model is comprised from revenues derived in four distinct business segments, vaccines, hospital drugs, ophthalmic drugs and contract pharma manufacturing. Each one of these business segments has a significant catalyst associated with it that is now providing or is expected to

 


 

provide significant revenue growth in 2008 and beyond. Allow me to present the advances and opportunities in each business segment.
The vaccine business segment was borne from an opportunity to exclusively distribute Massachusetts Biologic Laboratories tetanus diphtheria vaccine. The three-year exclusive arrangement was announced on March 2007.
Akorn’s strategy in entering this vaccine market was several fold:
  1)   Begin to expand and diversify our business into biologics and vaccines: an area that we believe represents greater longer term value, through bla licenses, with lesser competition.
 
  2)   The td vaccine has only one other competitor, Sanofi Pasteur and is approximately a market size of $225 million, a significant revenue opportunity for us.
 
  3)   An exclusive relationship would allow Akorn to act as a manufacturer’s representative and control market pricing, both direct and to distributors.

 


 

  4)   MBL had applied to FDA for a unit dose PF version of the vaccine, primarily used in hospitals, and through our hospital infrastructure we felt that we could compete with Sanofi and break this monopoly.
 
  5)   The relationship for this vaccine would allow us to build our distribution model for other vaccines and biologic products.
Initially, beginning in September 2007, Akorn began selling a multiple-dose version of the TD vaccine to distributors serving the office based physician and clinic markets.
From September 2007 to year-end we have generated revenues of $7.5 million from the TD vaccine.
More importantly, in late November 2007, and sooner than we expected, we announced MBL’s FDA approval for their udpf version of the vaccine. Since then, and because of this event, we have been able to contract with every major hospital group purchasing organization, including Novation and Premier and currently we have a sales team of approximately 50

 


 

representatives selling this vaccine in hospitals, clinics, to office based physicians and to distributors. This udpf version of the vaccine is no different than the MDV, that most office based physicians like to use, it is a price sensitive vaccine and if we can save a hospital or physician money, they will convert to our product. Since the udpf launch, we have converted 280 Hospitals through our direct selling efforts, these accounts represent approximately $3 million in annualized sales, the hospital market represents approximately $80 million of the $225 million TD market, until now a virtual monopoly for Sanofi.
54 Distributors also sell our vaccine, primarily to clinics and office based physicians.
We remain confident in our ability to ramp our sales of TD vaccine to eventually attain our target marketshare of 50% for the TD vaccine. At this share the TD vaccine represents a $100 million revenue opportunity for us at approximately 25% gross margins.
We will continue to announce our revenues for the TD vaccine in subsequent quarterly conference calls.

 


 

Recently, in February 2008 we announced an agreement to distribute CSL Biotherapies flu product, Afluria. Our strategy to enter this vaccine market was simple:
  1)   Our ability to lever up our 50 sales reps selling TD vaccine to the same customer base.
 
  2)   The overall size of the flu market 90-100 million doses/year $800 million market, potentially a large revenue opportunity for us.
 
  3)   And we believe we can help CSL gain marketshare in the U.S., they have both a pf and latex free PFS and a MDV vaccine.
Since our representatives have began pre-booking sales for the 2008 flu season, we have generated orders of $865,000 since we launched on February 22nd . Flu revenues are primarily recognized in August — October when the vaccine is delivered and shipped to customers.
Our expectations for the flu vaccine are nominal for 2008, representative of only one percent marketshare. However, from our selling experiences

 


 

in 2008 we expect to be able to significantly increase share in 2009 and beyond and expect to become a major distributor of flu vaccine in the U.S.
The td and flu vaccine are significant immediate revenue opportunities for Akorn but our more significant business relationship for vaccines is our partnership with Serum Institute. We announced our exclusive agreement in October 2007 with Serum from which we both intend to commercialize four of Serum’s vaccines for the U.S. market, hepatitis B, MMR, rabies and a bladder cancer vaccine. Along with an earlier announced exclusive development and marketing deal for a rabies monoclonal antibody product Serum represents our longer-term opportunity for vaccines. Through this partnership we intend to provide safe, efficacious and affordable vaccines for the U.S. healthcare consumer. You will hear more about this important partnership in 2008.
To recap, in 2006, Akorn had no potential revenue opportunities for vaccines, in 2007 we began to generate nominal vaccine revenues, our revenue opportunities in 2008 are significant, and our goal is to be a

 


 

major U.S. vaccine company, with a portfolio of affordable vaccine products by 2011.
We advanced our hospital business segment opportunities in 2007 in several ways.
First and foremost, and one of two main revenue opportunities for our hospital segment in 2008, is our relentless pursuit for a safe, effective and affordable generic oral vancomycin product. In 2007, a major milestone in our joint development and marketing partnership with Cipla for Vancomycin was the filing of the ANDA early in the 2nd quarter of 2007, our ANDA is not yet a year old.
In addition, we were granted an expedited review for this ANDA and our ANDA clearly demonstrates equivalency to the reference-listed drug, based on published FDA guidance and our CMC and stability results. Based on these facts I guided to a year-end ANDA approval for Vancomycin. Unfortunately, and to the detriment of the U.S. healthcare consumer, I was wrong.

 


 

The market opportunity for a safe, effective, generic version of oral vancomycin remains robust.
The monopoly continues to exist, where no patent does, and the market opportunity continues to grow, now at $225 million, primarily generated from price increases. We remain resolute in our pursuit of a safe and effective, affordable generic version of oral vancomycin and expect our generic approval to contribute to our revenue base in 2008.
Our second revenue opportunity in our hospital business segment is for the potential forward deployment of DTPA, our radiation chelating Agent, to be used most effectively within 4-6 hours of a nuclear accident of “dirty bomb” terrorist event.
After several senior level meetings with HHS officials we believe this forward deployment of DTPA to be representative of an important objective for HHS. Full-scale forward deployment of DTPA would represent a revenue opportunity for us of approximately $40-$50 million and would utilize the remaining DTPA units on our HHS contract. Forward deployment efforts could begin in the second half of 2008.

 


 

Lost in these two revenue opportunities are our product and business development efforts in the hospital business segment. An additional revenue opportunity exists from a schedule II narcotic ANDA, and we hope to receive approval in the third quarter, 2008.
In 2007, we continued in earnest our efforts in announcing product partnerships.
In January 2007, we announced the right
  1)   To exclusively market Hydase for Primapharm, and we expect to generate sales of $1.3 million in 2008
 
  2)   In July we announced with Cipla the exclusive development and supply oral and injectable version of an organ transplant rejection drug
 
  3)   In July we announced the exclusive development and supply of two injectable suspension products (one based in woman healthcare) with Hyaluron.

 


 

  4)   In September together with our partner Sofgen we submitted our ANDA after a successful biostudy for our 1st softgel capsule product, a controlled substance
 
  5)   In October, again with Sofgen we announced the exclusive development and supply of a softgel capsule drug product in womans healthcare
 
  6)   In November we announced the exclusive development and supply of an inhalation drug product again expanding our relationship with Cipla
 
  7)   And finally in December we announced the successful ANDA filing for our first anti-cancer injectable drug developed through our previously announced Serum Institute partnership
We currently have 40 product regulatory filings at FDA and our regulatory affairs department anticipates 22 product approvals in 2008, three have been received to date.

 


 

Several noted changes in our product development efforts are different markets, different container-closure systems, more representative of tougher to develop, advanced through clinical bio-studies niche specialty pharmaceutical products.
While our need to execute to our short-term catalysts remain paramount our need to maintain a constant flow of product development is just as important.
Our last remaining significant revenue opportunity for 2008 and longer term is in our ophthalmic business segment. In January 2007 we announced that we completed a pivotal phase III 200 patent. Clinical study with positive results for Akten, our internally developed NDA. Five months later in June we filed our NDA for Akten and we have received a PDUFA date in the 2nd quarter 2008. Of significance for Akten is its breadth of indication “for any ophthalmic procedure that requires a topical anesthetic”. We believe this provides for potential widespread use of Akten. At 20% use or share of the topical anesthetic market Akten would generate approximate sales of $20-$25 million at 80-85% gross margins. Because of Akten’s potential for widespread use across ophthalmology we will explore the opportunity to

 


 

partner with large pharma and their larger sized detail sales teams for potentially quicker uptake and use of Akten.
In 2007 we were not w/o our setbacks.
In February, we received a warning letter on our Decatur manufacturing plant. This effected IC-Green sales, which have subsequently recovered to historical levels, and effected any potential for new contract pharma manufacturing agreements, the main reason why our year over year contract pharma business unit sales decreased by $ 1.9 million year over year.
After our cGmp inspection later in the year we were found to be in substantial regulatory compliance, a significant event for our business in the short and long term. For 2008, it affords us the opportunity to grow our contract pharma manufacturing revenues and we have seen large pharma companies visit Akorn with renewed interest. For the longer term, the inspection also included a pre-approval inspection for our new injectable and lyophilized fill suits. The successful result from this PAI inspection allows our manufacturing asset to be placed in service. This fill suite is a state of the art design that requires little manual intervention and represents a

 


 

significant upside opportunity for our lyophized contract pharma manufacturing business. We would expect to begin to realize revenues in 2009 through lyophilized clinical batch manufacturing and a more significant rise in lyophilized contract pharma revenues in 2010-2011.
At this time in our presentation, I will turn the presentation over to Jeff Whitnell who will describe to you our financial position.
Thank you, Jeff.
To reiterate: Our significant short-term revenue opportunities for 2008 are:
  1)   In vaccines: the sales ramp for our TD vaccine
: and our flu vaccine sales
  2)   In hospital drugs: our FDA approval for ANDA for oral vancomycin
: our forward deployment revenue opportunity for DTPA
: and our FDA approval for our ANDA for a CII narcotic
  3)   In ophthalmic drugs: our FDA approval for Akten and its 2nd Quarter
:Pdufa date

 


 

  4)   In contract pharma: our manufacturing plants operate in a state of substantial compliance and are free to attract contract pharma business, including lyophilization
I would like to thank our two analysts Noelle Tune from Neponset Soleil who has been providing coverage for the last three years and Scott Hirsch from CSFB, our newest analyst.
I will not open our conference call to questions.
In closing:
I am acutely aware of our recent drop in our market valuation, be it the result of the overall market downturn, no vancomycin approval, our short position, pick you poison, but I believe in and remain committed to our business model, strategies, and both our short and long term opportunities. We have several short-term significant revenue opportunities, each unique and diversified, and we are certainly not a “one product” type company. Our

 


 

longer term opportunities are in place and include 40 ANDA filings and numerous development projects and I believe our vaccine relationship with Serum is unique in today’s pharma market place. Ultimately, our near term and future market valuation will be dictated by our ability to execute and deliver results as represented by our business model and it’s opportunities. That is my job, to deliver these results, but I am pleased that we have built such a significant number of opportunities to draw upon and execute against.
Thank you for your time and attention today.

Good evening.

 

EX-99.3 4 c24785exv99w3.htm SCRIPT OF CONFERENCE CALL exv99w3
 

Exhibit 99.3
Thank you, Art, and good afternoon ladies and gentlemen.
Total revenue for the fourth quarter 2007 was $13.7 million, versus $14.6 million in the fourth quarter 2006. The year-over-year decline is principally due to the lack of DTPA revenue in this year’s fourth quarter results. During the fourth quarter 2007, Ophthalmic and Hospital Drugs and Injectables business segment revenues (excluding DTPA) increased by approximately 40% and 11% respectively, versus the prior year comparative period. In our Ophthalmic business segment, net revenues were $5.4 million vs. $3.9 million for Q4’06, and reflect strong sales of our diagnostic products, primarily IC-Green and AK-Fluor. The Hospital Drugs and Injectables business segment net revenues were $4.2 million vs. $3.8 million for Q4’06, led by greater hospital contract compliancy.
The Company recorded DTPA product revenues of $3.6 million in the fourth quarter 2006 and negligible DTPA product revenue in the fourth quarter 2007. The Company also recorded Vaccine revenues of approximately $2.8 million in the fourth quarter 2007. The Contract Services business segment net revenues were $1.3 million vs. $3.2 million in the comparative prior year period, a decline of $1.9 million.
In the fourth quarter 2007, the Company announced the successful results of the FDA inspection for the Decatur, IL facility. The satisfactory resolution of past cGMP issues and a successful pre-approval inspection of the lyophilization facility are both significant events. Further, Regulatory compliance in Decatur will enable us to actively market and increase our contract services business segment net revenues, including the introduction of our lyophilization capabilities
Gross profit for the fourth quarter 2007 was $3.1 million as compared to $4.2 million in the fourth quarter 2006. The aggregate decline in fourth quarter 2007 gross profit versus the comparative prior year period was due to product mix and the prior year DTPA order. Sequentially, fourth quarter 2007 gross margin improved to 22.3% versus the third quarter 2007 gross margin of 18.8%. Lower Contract Services business segment volumes resulted in under absorbed manufacturing costs at our Decatur, IL production facility. Consequently, the Company has completed a reorganization that will generate projected annual cost savings of approximately $2.0 million.
Selling, general and administrative expenses totaled $6.1 million in the fourth quarter 2007, an increase of $0.8 million over the comparative prior year period. This increase is due to the investment in our newly created Vaccine Sales Team of twenty sales representatives, bringing the total Field and Inside Sales Representatives at the Company to 50.
Research and development expenses were $1.5 million in the fourth quarter 2007 versus $5.0 million in the comparative prior year period, and reflect lower milestone payments for product development efforts.

 


 

The net loss available to common stockholders for the fourth quarter 2007 was $5.0 million or $0.06 per fully diluted share, vs. the net loss available to common stockholders of $6.2 million in the fourth quarter 2006 or $0.07 per fully diluted share. The December 31, 2007 fully diluted share count for the Company is 92,446,930, which assumes stock options and warrants are outstanding for the full year rather than on a weighted average basis. As of December 31, 2007, the Company had cash and cash equivalents equal to $7.9 million and $10.5 million of undrawn availability under our Credit Agreement.
I would now like to draw your attention to the Balance Sheet. We ended the fourth quarter 2007 with $7.9 million in Cash and Cash Equivalents. In addition, we have a Restricted Cash account balance of $1.25 million with our commercial banker. As of December 31, 2007, the outstanding borrowing against our line of credit was $4.5 million, with an additional $10.5 million available under our $15.0 million Credit Facility. We expect to be cash flow positive in the second half of 2008 and have sufficient working capital to meet our business requirements this year.
The assets on our balance sheet have increased year over year, by approximately 6% in 2007, a reflection of multi-dose Tetanus Diphtheria vaccine and the corresponding inventory position. Today, Akorn is the only MDV supplier of Td-Vaccines in the marketplace with product dating greater than 12 months, and we look forward to servicing this important market through 2009. At that time, the supply of MDV will be exhausted in the marketplace and we will have transitioned our customers to the UDPF vaccine, primarily in the office-based physician market. As of December 31, 2007, we have no long-term debt, a nominal mortgage obligation that will be retired in June 2008 and a Current Ratio at year-end equal to 2.2.
Finally, I would like to briefly review the Statement of Cash Flows. During the fourth quarter 2007, we invested a total of $714,000, in Equipment and Software along with our investment in a product license with one of our development partners. The majority of our capital investments were for necessary machinery and equipment upgrades as well as our ongoing investment in new software and hardware to accommodate electronic FDA filings by our Corporate Regulatory Affairs Group.
We are also pleased to announce that our 2007 Form 10-K will be filed with the Securities and Exchange Commission this week, and that our independent registered public accountants have issued an unqualified audit opinion on the consolidated financial statements. In addition, their review of our internal control procedures indicated no material internal control weaknesses or significant deficiencies. For fiscal year 2008, we have engaged Ernst & Young LLP to be our independent registered public accounting firm
Thank you for your time and attention. I will now turn the teleconference back to Art.

 

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