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Penederm Inc · 10-Q · For 6/30/96

Filed On 8/13/96 · SEC File 0-23112 · Accession Number 858876-96-3

  As Of               Filer                 Filing     On/For/As Docs:Pgs

 8/13/96  Penederm Inc                      10-Q        6/30/96    2:15

Quarterly Report · Form 10-Q
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-Q        Quarterly Report                                      14     53K 
 2: EX-27       Financial Data Schedule                                1      6K

10-Q · Quarterly Report
Document Table of Contents

Page	(sequential)	\|	(alphabetic)	Top
			Alternative Formats (RTF, XML, et al.) Exhibits and Reports on Form 8-K Legal Proceedings Management's Discussion and Analysis of Financial Condition and Results of Operations Management's Discussion and Analysis of Financial Condition and Results of Operations, continued Submission of Matters to a Vote of Security Holders
1	1st Page
6	Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
7	Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations, continued
12	Item 1. Legal Proceedings
"	Item 4. Submission of Matters to a Vote of Security Holders
"	Item 6. Exhibits and Reports on Form 8-K

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UNITED STATES                                                                   
SECURITIES AND EXCHANGE COMMISSION                                              
Washington, DC  20549                                                           

FORM 10-Q                                                                       

[ X ]    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE                
SECURITIES EXCHANGE ACT OF 1934                         

For the quarterly period ended     JUNE 30, 1996                                

Commission File Number          0-22314                                         

PENEDERM INCORPORATED                             
(Exact name of registrant as specified in its charter)                          

CALIFORNIA                    77-0146116                      
(State of other jurisdiction of       I.R.S. Employer                           
incorporation or organization)      Identification Number                       

320 LAKESIDE DRIVE, FOSTER CITY,  CALIFORNIA       94404                        
(Address of principal executive offices)        (Zip Code)                    

(415) 358-0100                                          
(Registrant's telephone number, including area code)                            

Indicate by check whether the registrant (1) has filed all reports              
required to be filed by section 13 or 15(d) of the Securities Exchange          
Act of 1934 during the preceding 12 month (or for such shorter period           
that the registrant was required to file such reports), and (2) has been        
subject to such filing requirements for the past 90 days.                       

YES    X        NO                                        

Indicate number of shares outstanding of each of the issuer's classes of        
common stock, at the latest practicable date:                                   

Class     Outstanding as of:     JUNE 30, 1996                          

Common Stock                 7,257,524                                  

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Part I:  Financial Information                                                  

PENEDERM INCORPORATED                                                           
Condensed Consolidated Balance Sheets                                           
June 30, 1996 and December 31, 1995 (in thousands)                              
                        June 30,          December 31,
                     1996               1995
                    -----------         ----------
ASSETS                             (unaudited)                                  
Current Assets:                                                                 
Cash and cash equivalents        $   1,525           $   8,695              
Short-term marketable securities     6,050               4,796              
Accounts receivable                    968                 862              
Inventory                              401                 301              
Prepaid expenses and other                                                  
current assets                        544                 467             
                    -----------         ----------
Total current assets               9,488              15,121            

Marketable Securities                2,863               1,520              
Fixed assets, at cost, less                                                 
accumulated depreciation and                                              
amortization                          298                 282             
Intangible and other assets          1,085               1,045              
                   ------------        -----------
Total assets                  $   13,734          $   17,968            
                   ===========         ===========
LIABILITIES                                                                     
Current liabilities:                                                            
Accounts payable                $      776          $      791              
Accrued and other liabilities        1,174               1,166              
                   ------------        -----------
Total current liabilities          1,950               1,957            

Long-term debt obligations              50                  77              
                   ------------        -----------
Total liabilities                  2,000               2,034            

SHAREHOLDERS' EQUITY                                                            
Common stock, no par value            46,798              46,684                
Accumulated Deficit                  (35,064)            (30,750)               
                   ------------        -----------
Total shareholders' equity        11,734              15,934            
                   ------------        -----------
Total liabilities and                                                   
shareholders' equity         $   13,734          $   17,968           
                   ===========         ===========

See accompanying notes to condensed consolidated financial statements.          

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PENEDERM INCORPORATED                                                           
Condensed Consolidated Statements of Operations                                 
(in thousands, except per share data)                                           
(unaudited)                                                                     

               Three Months Ended         Six Months Ended
                June 30,                    June 30,
               1996          1995          1996           1995
               ------        ------        ------         ------
REVENUES                                                                        
Product sales     $  1,100      $  1,020       $  1,693      $  2,354       
License and research                                                        
contract income      --             600            207           600      
            ---------     ---------      ---------     ---------
Total revenues     1,100         1,620          1,900         2,954     
            ---------     ---------      ---------     ---------
COSTS AND EXPENSES                                                              
Cost of sales          687           702          1,115         1,344       
Research and                                                                
development         1,259         1,234          3,121         2,347      
Selling, general and                                                        
administration      1,122           984          2,308         2,136      
            ---------     ---------      ---------     ---------
Total costs and                                                         
expenses          3,068         2,920          6,544         5,827    
            ---------     ---------      ---------     ---------

Loss from operations  (1,968)       (1,300)        (4,644)       (2,873)        
             --------      --------       --------      --------
Interest income, net     154           255            330           510         
             --------      --------       --------      --------
Net loss             $(1,814)      $(1,045)       $(4,314)      $(2,363)        
             ========      ========       ========      ========
Net loss per share   $( 0.25)      $( 0.15)       $( 0.59)      $( 0.33)        
             ========      ========       ========      ========
Number of shares used                                                           
in computing net                                                              
loss per share        7,257         7,153          7,256         7,147        
             ========      ========       ========      ========

See accompanying notes to condensed consolidated financial statements.          

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PENEDERM INCORPORATED                                                           
Condensed Consolidated Statements of Cash Flows                                 
(in thousands)                                                                  
(unaudited)                                                                     
                        Six Months Ended
                          June 30,
                        1996              1995
                       -------           -------
CASH FLOWS FROM OPERATING ACTIVITIES:                                           
Net loss                            $( 4,314)         $( 2,363)               
Adjustments to reconcile net loss                                             
to net cash used in operating                                               
activities:                                                                 
Loss on disposal of fixed assets      --                 127              
Depreciation and amortization          130               117              
Increase in accounts receivable    (   106)          (   645)             
Decrease (increase) in inventory   (   100)              293              
Increase in prepaid expenses and                                          
other current assets              (    77)          (    19)            
Decrease in accounts payable,                                             
accrued liabilities and deferred                                        
rent                              (    10)          ( 1,221)            
                     ---------          --------
Net cash used in operating                                            
activities                      ( 4,477)          ( 3,711)          
                     ---------          --------
CASH FLOWS FROM INVESTING ACTIVITIES:                                           
Maturity of held-to-maturity                                                  
securities                             --               1,000               
Purchase of available-for-sale                                                
securities                          ( 6,908)          ( 3,932)              
Maturity of available-for-sale                                                
securities                            4,051             4,686               
Sale of available-for-sale securities    260              --                  
Acquisition of technology            (   100)          ( 1,098)               
Acquisition of fixed assets          (    86)          (   139)               
                     ---------         ---------
Net cash from (used in)                                               
investing activities            ( 2,783)             517            
                     ---------         ---------
CASH FLOWS FROM FINANCING ACTIVITIES:                                           
Proceeds from issuance of common stock   114              139                 
Borrowing (repayment) of long-term                                            
debt, net                           (    24)               1                
                      --------          --------
Net cash provided by financing                                        
activities                           90              140            
                      --------          --------
Net decrease in cash and cash                                                   
equivalents                          ( 7,170)          ( 3,054)               
Cash and cash equivalents at                                                    
beginning of period                    8,695             6,728                
                      --------          --------
Cash and cash equivalents at end                                                
of period                            $ 1,525           $ 3,674                
                      ========          ========

See accompanying notes to condensed consolidated financial statements.          

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PENEDERM INCORPORATED                                                           
NOTES TO CONDENSED FINANCIAL STATEMENTS                                         
(unaudited)                                                                     

Interim Unaudited Financial Information:                                        

The accompanying interim unaudited condensed financial statements of the        
Company for the three and six month periods ended June 30, 1996 and             
1995, have been prepared in accordance with generally accepted                  
accounting principles for interim financial statements and include all          
adjustments (consisting of normal and recurring adjustments) that the           
Company considers necessary for a fair presentation of the operating            
results and cash flows for these periods. The results of operations for         
the interim periods are not necessarily indicative of the results to be         
expected for an entire year.  These financial statements should be read         
in conjunction with the financial statements and notes included as part         
of the Company's Form 10-K for the year ended December 31, 1995.                

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Item 2.  Management's Discussion and Analysis of Financial Condition and        
Results of Operations                                                           

Overview                                                                        

Penederm is developing and commercializing topically administered               
prescription dermatology products that use the Company's proprietary            
delivery technology or novel drug compounds to achieve enhanced safety          
or efficacy profiles.  Penederm has recently received notification from         
the FDA that its NDA for MENTAX (trademark)(topical athlete's foot              
treatment), is approvable.  The Company currently has NDAs pending              
before the FDA for treatment of other skin fungus indications with              
MENTAX and for AVITA (trademark) gel and AVITA cream topical retinoic           
acid acne treatments, and has two other pharmaceutical products for             
psoriasis and nail fungus in human clinical trials.  The Company also           
sells its patented TopiCare Delivery Compounds (registered trademark)           
for use in cosmetics and personal care products.  The Company has               
several agreements with various pharmaceutical companies, as follows:           

COMPANY               PRODUCT AREA                   TERRITORY        
-----------------       -----------------            ------------------         
Schering-Plough    Prescription & over-the-counter     U.S. and Canada          
HealthCare         (OTC) Nail and Skin Antifungals                              
Products, Inc.                                                                  
(Schering-Plough)                                                               

UCB Group of       Prescription Nail Antifungal      Europe, Africa and         
Belgium (UCB)                                           Middle East             

Warner Wellcome Consumer    OTC Dry Skin              U.S. and Canada           
Health Products (Warner)                                                        

SmithKline Beecham      OTC Consumer Products              Europe               
(SmithKline)                                                                    

The Company has been unprofitable since inception and expects to incur          
significant additional operating losses in the near future. For the             
period from inception through June 30, 1996, the Company incurred a             
cumulative net loss of  $35,064,000. Penederm's sources of working              
capital have been equity financings, product sales to Warner, sales of          
over-the-counter products, product license fees and contract research           
revenues, sales of TopiCare Delivery Compounds and interest earned on           
investments.                                                                    

Recent Events                                                                   

In April 1996, the FDA notified the Company that its NDA for MENTAX             
(butenafine HCl cream), a topical treatment for interdigital tinea pedis        
(athlete's foot) was approvable. The Company must supply certain data to        
the FDA and complete its product labeling discussions with the agency           
prior to obtaining final approval.                                              

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Item 2.  Management's Discussion and Analysis of Financial Condition and        
Results of Operations, continued                                                

Recent Events, continued                                                        

In May 1996 Mr. Robert F. Allnutt, Executive Vice President of the              
Pharmaceutical Manufacturers Association, and Mr. Mark J. Gabrielson,           
President of Access Management Services, Inc. and General Partner of            
Prince Ventures, joined the Board of Directors to fill vacancies created        
by Tom McConnell, a General Partner of New Enterprise Associates, and           
Philip Young, a General Partner of U.S. Venture Partners, not standing          
for re-election.                                                                

In June 1996, the Company received a non-approvable letter from the FDA         
regarding its NDAs for AVITA, the Company's retinoic acid formulations          
for acne treatment.  The FDA requested an additional study to document          
the efficacy of the gel formulation.  The Company had already completed         
an additional efficacy trial on AVITA gel and submitted the results to          
the FDA in a July 1996 amendment.                                               

Results of Operations                                                           

Three Months Ended June 30, 1996 and 1995                                       

Total revenues for the three months ended June 30, 1996 of $1,100,000           
decreased 32% from $1,620,000 in the same period of 1995, due primarily         
to lower quantities of Lubriderm products shipped to Warner as compared         
to 1995 launch quantities and a decline in Penederm cream and lotion            
sales, as a result of reduced promotion spending. The Company reduced           
promotional spending on Penederm cream and lotion in order to direct            
more resources to prescription product human clinical trials. Based on          
current product demand forecasts from Warner, the Company anticipates           
sales to Warner will continue to be less than previous levels for the           
remainder of 1996 and 1997.                                                     

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Item 2.  Management's Discussion and Analysis of Financial Condition and        
Results of Operations, continued                                                

Results of Operations, continued                                                

The Company's cost of sales decreased to $687,000 in the three months           
ended June 30, 1996 from $702,000 in the same period of 1995 primarily          
due to the decrease in the manufacturing of products for Warner.  Gross         
margins declined in the second quarter of 1996 compared to the same             
period of 1995 due to lower sales levels and a change in the mix of             
product revenues.                                                               

The Company's research and development expenses remained relatively flat        
for the second quarter at $1,259,000 in the three months ended June 30,         
1996 compared to $1,234,000 in the same period of 1995.                         

Sales, marketing, general and administrative expenses increased 14% to          
$1,122,000 in the three months ended June 30, 1996 from $984,000 in the         
same period of 1995 due primarily to increased legal costs related to           
enforcement of patent rights, commissions on increased TopiCare Delivery        
Compound sales and the costs of pre-launch preparations for MENTAX, the         
Company's topical antifungal product, partially offset by reduced               
personnel costs.                                                                

Interest income for the three months ended June 30 decreased 40% to             
$154,000 in 1996 from $255,000 for the same period in 1995. This                
decrease is primarily the result of lower cash balances available for           
investment in the three months ended June 30, 1996.                             

Six Months Ended June 30, 1996 and 1995                                         

Total revenues for the six months ended June 30, 1996 of $1,900,000             
decreased 36% from $2,954,000 in the same period of 1995, due primarily         
to lower quantities of Lubriderm products shipped to Warner as compared         
to 1995 launch quantities and a decline in Penederm cream and lotion            
sales, as a result of reduced promotion spending.                               

The Company's cost of sales decreased to $1,115,000 in the six months           
ended June 30, 1996 from $1,344,000 in the same period of 1995 primarily        
due to the decrease in the manufacturing of products for Warner.  Gross         
margins declined in the first half of 1996 compared to the same period          
of 1995 due to lower sales levels and a change in the mix of product            
revenues.                                                                       

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Item 2.  Management's Discussion and Analysis of Financial Condition and        
Results of Operations, continued                                                

Results of Operations, continued                                                

Six Months Ended June 30, 1996 and 1995, continued                              

The Company's research and development expenses increased 33% to                
$3,121,000 in the six months ended June 30, 1996 from $2,347,000 in the         
same period of 1995 primarily due to the cost of human clinical trials          
to establish additional claims for both AVITA (acne treatment) and              
MENTAX (skin antifungal).  These studies encompassed 1,600 patients over        
26 sites across the U.S. and Canada.                                            

Sales, marketing, general and administrative expenses increased 8% to           
$2,308,000 in the six months ended June 30, 1996 from $2,136,000 in the         
same period of 1995 due primarily to increased legal costs related to           
enforcement of patent rights, commissions on increased TopiCare Delivery        
Compound sales and the costs of pre-launch preparations for MENTAX, the         
Company's topical antifungal product, partially offset by reduced               
personnel costs.                                                                

Interest income for the six months ended June 30 decreased 35% to               
$330,000 in 1996 from $510,000 for the same period in 1995. This                
decrease is primarily the result of lower cash balances available for           
investment in the six months ended June 30, 1996.                               

The Company expects that future operating results may be subject to             
quarterly variations that may impact cash flow from operations.                 
Operating results for the quarter and six month period ended June 30,           
1996 are not necessarily indicative of future operating results.                

Liquidity and Capital Resources                                                 

In November 1993, the Company completed its initial public offering of          
Common Stock, raising approximately $23,000,000 net of expenses. Prior          
to the initial public offering, the Company financed operations                 
primarily through private placements of its equity securities, interest         
income earned on investment of cash, initial sales of products and              
product license fees. At June 30, 1996, the Company had cash, cash              
equivalents and investments totaling $10,438,000.                               

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Item 2.  Management's Discussion and Analysis of Financial Condition and        
Results of Operations, continued                                                

Liquidity and Capital Resources, continued                                      

Cash expenditures related to operating activities and the acquisition of        
fixed assets and repayment of long-term obligations totaled $4,587,000          
in the six months ended June 30, 1996 and $3,849,000 for the same period        
in fiscal 1995, and were used to finance research, development, clinical        
trials, product sales, promotion and general administration activities.         
The Company also made milestone payments of $100,000 and $1,098,000             
related to the in-licensing of drug compounds in the six months ended           
June 30, 1996 and 1995 respectively.  The Company expects that amounts          
expended historically are not indicative of future expenditures by the          
Company, which the Company believes will increase. The Company expects          
to continue to incur substantial expenses related to the further                
research and development of its technologies, development of its                
products, acquisition of additional products and rights to drug                 
compounds, patent prosecution expenses and sales and marketing.  These          
expenses include, but are not limited to, increases in personnel and            
personnel-related costs, inventory and accounts receivable and capital          
expenditures, and may also include costs of facilities expansion.               

The Company believes that existing capital resources, and the interest          
income earned thereon, together with anticipated revenues (consisting of        
product sales, license fees and royalties), will satisfy the Company's          
working capital and identified capital expenditure requirements through         
the end of 1997.  However, the Company's future capital requirements            
will depend on many factors, including the timing of regulatory                 
approvals, the progress of the Company's collaborative and independent          
research and development programs, payments received under collaborative        
agreements with other companies, if any, the results and costs of               
preclinical and clinical testing for the Company's products, the costs          
associated with product and compound acquisition opportunities,                 
technological advances, the status of competitive products, and the             
commercial success of Penederm's licensing and marketing efforts. There         
can be no assurance that additional funds, if required, will be                 
available to the Company on favorable terms, if at all, to permit the           
Company to continue with its plan for operations.                               

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Item 2.  Management's Discussion and Analysis of Financial Condition and        
Results of Operations, continued                                                

Liquidity and Capital Resources, continued                                      

Uncertainties Related to Forward-Looking Statements                             

Any statements contained in this 10-Q that relate to future plans,              
events or performance are forward-looking statements that involve risks         
and uncertainties including, but not limited to, risks of product non-          
approval or delays by the FDA or foreign regulatory authorities, product        
development and market acceptance risks, the impact of competitive              
products and pricing, the results of current and future licensing and           
other collaborative relationships, the results of financing efforts,            
developments regarding intellectual property rights and litigation, and         
other risks detailed in the Company's Annual Report on Form 10-K for the        
year ended December 31, 1995.  Actual results may differ materially.            
Readers are cautioned not to place undo reliance on these forward-              
looking statements, which speak only as of the date hereof.  The Company        
undertakes no obligation to publicly release the results of any                 
revisions to these forward-looking statements that may be made to               
reflect events or circumstances after the date hereof or to reflect the         
occurrence of unanticipated events.                                             

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PENEDERM INCORPORATED                                                           

Part II:  Other Information                                                     

Item 1.  Legal Proceedings                                                      

On July 22, 1996, Johnson & Johnson filed a complaint against Penederm          
in the U.S. District Court, Northern District of California alleging            
that AVITA gel, one of the Company's four retinoic acid acne                    
formulations, infringes a Johnson & Johnson patent (the "J&J Patent").          
The J&J Patent expires on January 27. 1998. Based on prior opinion of           
counsel, Penederm believes that AVITA does not infringe the J&J Patent.         
The Company believes that the litigation will not affect the timing of          
the FDA's review of the NDA for the Company's three AVITA cream                 
formulations and will not have a material adverse effect on the                 
Company's business, financial position and results of operations.               
However, pursuant to FDA regulations, although the FDA can issue an             
approval it cannot make any approval for the AVITA gel effective prior          
to the expiration of the J&J Patent if the lawsuit is pending. There can        
be no assurance that the lawsuit will not delay the timing of the market        
introduction of AVITA gel, will not result in some diversion of                 
management attention or will not require substantial expenditures to            
defend or resolve.                                                              

Item 4.  Submission of Matters to a Vote of Security Holders                    

The Company held its annual meeting of shareholders on May 14, 1996.  At        
the meeting, the shareholders considered the items described below:             

Each of the nominees for director Terry L. Opdendyk, Lloyd H. Malchow,          
William I. Bergman, David E. Collins, Harvey S. Sadow, Ph.D., Gerald D.         
Weinstein, M.D., were elected by the affirmative vote of at least               
5,841,830 shares (out of 5,841,830 shares represented at the meeting).          

The shareholders voted to approve an amendment to the Penederm                  
Incorporated Employee Stock Purchase Plan to increase by 50,000 the             
number of shares reserved for issuance under the plan.  The amendment           
was approved by a vote of 4,336,703 shares for, 20,128 shares against           
and 3,691 shares abstaining.                                                    

The shareholders voted to approve an amendment to the Penederm                  
Incorporated Equity Incentive Plan to increase by 400,000 the number of         
shares reserved for issuance under the plan.  The amendment was approved        
by a vote of 3,540,022 shares for, 798,891 shares against and 1,061             
shares abstaining.                                                              

The shareholders voted to approve certain amendments to the Penederm            
Incorporated 1994 Nonemployee Directors Stock Option Plan to increase           
the initial and annual grants to directors from 5,000 shares to 7,500           
shares, toprovide that a director shall receive an annual grant at the          
first board meeting following an annual meeting unless that director's          
initial grant was made on or after the record date for the annual               
meeting, and to provide that any non-employee director who has not              
received either an initial grant or an annual grant since the record            
date for the 1995 annual meeting of shareholders shall be granted an            
option to purchase 12,500 shares in lieu of an annual grant for 1996.           
The amendments were approved by a vote of 4,573,819 shares for, 833,688         
shares against 5,330 shares abstaining.                                         

Item 6.  Exhibits and Reports on Form 8-K                                       

(a)  Exhibits                                                                   

27        Financial Data Schedule                   

(b)  Reports on Form 8-K - Not Applicable                                       

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SIGNATURES                                                                      

Pursuant to the requirements of the Securities and Exchange Act of 1934,        
the registrant has duly caused this report to be signed on its behalf by        
the undersigned, thereunto duly authorized.                                     

                       PENEDERM INCORPORATED

/S/  Lloyd H. Malchow                   August 12, 1996                         
Lloyd H. Malchow, President                                                     
and Chief Executive Officer                                                     

/S/  Edgar Luce                         August 12, 1996                         
Edgar Luce, Vice President of                                                   
Finance and Administration                                                      

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INDEX TO EXHIBITS                                                               

Exhibit                                                                     
No.               Description                                           
----------    --------------------------------------------------                
27               Financial Data Schedule

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Dates Referenced Herein and Documents Incorporated By Reference

		Referenced-On Page
This 10-Q Filing	Date	First	Last	Other Filings

	6/30/95	5	10
	12/31/95	2	11	10-K/A
	5/14/96	12
For The Period Ended	6/30/96	1	10
	7/22/96	12
	8/12/96	13
Filed On / Filed As Of	8/13/96

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Penederm Inc · 10-Q · For 6/30/96

Filed On 8/13/96 · SEC File 0-23112 · Accession Number 858876-96-3

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Dates Referenced Herein and Documents Incorporated By Reference

Quarterly Report · Form 10-Q
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