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OMPI > SEC Filings for OMPI > Form 10-Q on 9-May-2011All Recent SEC Filings

Show all filings for OBAGI MEDICAL PRODUCTS, INC. | Request a Trial to NEW EDGAR Online Pro

Form 10-Q for OBAGI MEDICAL PRODUCTS, INC.


9-May-2011

Quarterly Report


ITEM 2: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-looking statements

In addition to historical information, this report on Form 10-Q contains certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or future financial performance, and include statements regarding our business strategy, timing of, and plans for, the introduction of new products and enhancements, future sales, market growth and direction, the effects of future regulations, litigation, competition, market share, revenue growth, operating margins and profitability. All forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, expressed or implied, by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology. These statements are only predictions and are based upon information available to us as of the date of this report. We undertake no ongoing obligation to update these forward-looking statements.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results. These forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the risks and uncertainties described in the "Risk Factors" section of our 2010 Annual Report on Form 10-K and Item IA of Part II of this report on Form 10-Q. You are urged to carefully consider these factors. All forward-looking statements attributable to us are expressly qualified in their entirety by the foregoing cautionary statements.

Overview and Recent Developments

The following discussion is intended to help the reader understand the results of operations and financial condition of Obagi Medical Products, Inc. This discussion is provided as a supplement to, and should be read in conjunction with, our consolidated financial statements and the accompanying notes to the consolidated financial statements.

We are a specialty pharmaceutical company that develops, markets and sells, and are a leading provider of, proprietary topical aesthetic and therapeutic prescription-strength skin care systems in the physician-dispensed market. Our products are designed to prevent and improve the most common and visible skin disorders in adult skin, including premature aging, photodamage, skin laxity, hyperpigmentation, acne, sun damage, facial redness and soft tissue deficits, such as fine lines and wrinkles.

Current products. Our primary product line is the Obagi Nu-Derm System, which we believe is the leading clinically proven, prescription-based, topical skin health system on the market that has been shown to enhance the skin's overall health by correcting photodamage at the cellular level, resulting in a reduction of the visible signs of aging. The primary active ingredients in this system are 4% hydroquinone and OTC skin care agents. In April 2004, we introduced the Obagi-C Rx System consisting of a combination of prescription and OTC drugs and adjunctive cosmetic skin care products to treat skin conditions resulting from sun damage and the oxidative damage of free radicals. The central ingredients in this system are 4% hydroquinone and Vitamin C. In October 2005, we launched the Obagi Professional-C products, a complete line of proprietary, non-prescription products, which consists of Vitamin C serums used to reduce the appearance of damage to the skin caused by ultraviolet radiation and other environmental influences. In July 2006, we launched our Obagi Condition & Enhance System, for use in conjunction with commonly performed surgical and non-surgical cosmetic procedures. In October 2006, we launched our first product in the ELASTIderm product line, an eye cream for improving the elasticity and skin tone around the eyes. We introduced the Obagi CLENZIderm M.D. system and a second product in the ELASTIderm product line to address acne and skin elasticity around the eye, respectively, based on positive interim clinical results, in February 2007. In July 2007, we launched our second system in the CLENZIderm M.D. line, CLENZIderm M.D. System II, which is specifically formulated for normal to dry skin. In August 2007, we launched two new Nu-Derm Condition & Enhance Systems. One is designed specifically for use with non-surgical procedures while the other has been developed for use with surgical procedures. In February 2008, we launched ELASTIderm Décolletage, a system to treat skin conditions resulting from sun damage and improve the elasticity and skin tone for the neck and chest area. In January 2009, we launched Obagi Rosaclear, a system to treat the symptoms of rosacea. In September 2009, we also began offering Refissa by Spear, a FDA-approved 0.05% strength tretinoin with an emollient base that has a broad indication for treatment of fine facial lines, hyperpigmentation and tactile roughness. In October 2010, we launched ELASTILash Eyelash Solution, a peptide-based eyelash solution that can help achieve the appearance of thicker, fuller-looking eyelashes. In January 2011, we launched Blue Peel RADIANCE, a gentle salicylic acid-based peel that utilizes a unique blend of acids and other soothing ingredients to


exfoliate, even out skin tone and improve overall complexion, with little-to-no downtime. We also market tretinoin, used for the topical treatment of acne in the U.S., metronidazole, used for the treatment of rosacea in the U.S., and the Obagi Blue Peel Essential Kit, used to aid the physician in the application of skin peeling actives.

Future products. We focus our research and new product development activities on improving the efficacy of established prescription and OTC therapeutic agents by enhancing the penetration of these agents across the skin barrier using our proprietary technologies collectively known as Penetrating Therapeutics. However, we cannot assure you that we will be able to introduce any additional systems using these technologies.

U.S. distribution. We market all of our products through our direct sales force in the United States primarily to plastic surgeons, dermatologists and other physicians who are focused on aesthetic skin care.

Aesthetic skin care. As of March 31, 2011, we sold our products to over 6,500 physician-dispensing accounts in the United States, with no single customer accounting for more than 5% of our net sales. Our current products are not eligible for reimbursement from third-party payors such as health insurance organizations. We generated U.S. physician-dispensed sales of $21.7 million during each of the three month periods ended March 31, 2011 and 2010.

International distribution. We market our products internationally through 20 international distribution and two licensing partners that have sales and marketing activities in 45 countries outside of the United States. Our distributors use a model similar to our business model in the United States, selling our products through direct sales representatives to physicians, or through alternative distribution channels depending on regulatory requirements and industry practices. We generated international physician-dispensed sales of $3.3 million and $3.0 million during the three months ended March 31, 2011 and 2010, respectively.

Licensing. We market our products in the Japanese retail markets through license agreements with Rohto. Under our agreements, Rohto is licensed to manufacture and sell a series of OTC products developed by it under the Obagi brand name, as well as Obagi-C products, in the Japanese drug store channel, and we receive a royalty based upon Rohto's sales of Obagi branded products in Japan. Rohto sells and markets Obagi branded products through high-end drug stores. We have other licensing arrangements in Japan to market and sell OTC product systems under the Obagi brand, both for in-office use in facial procedures, as well as for sale as a take-home product kit in the spa channel. We receive royalties based upon these arrangements. We generated licensing revenue of $1.6 million and $1.0 million during the three months ended March 31, 2011 and 2010, respectively.

In March 2011, the northern region of Japan experienced a severe earthquake followed by a tsunami and nuclear disasters. These events caused significant damage in that region and have adversely affected Japan's infrastructure and economy. Our third-party licensees are located in Japan and they may experience a slowdown in operations and may otherwise be negatively impacted as a result of these events. Our license revenue from Japan accounted for 6% and 4% of our total net sales for the three months ended March 31, 2011 and 2010, respectively. Based on information provided by certain of our Japanese licensees, we do not currently expect the recent crisis to significantly harm our license revenue from Japan. However, should the situation in Japan worsen, our license revenue from our Japanese licensees may be negatively impacted. During the year ended December 31, 2010, licensing revenue represented approximately 3.9% of our total net sales.

Impairment of license. In 2004, we entered into a license agreement with a third-party licensor to market and sell products containing a specific range of Kinetin concentration in Japan (see Note 3 in the Notes to Unaudited Condensed Consolidated Financial Statements). We subsequently, sublicensed these rights to an international distributer in Japan. During the three months ended March 31, 2011, our sublicensee discontinued the manufacture and sale of products containing the Kinetin concentration. In addition, neither we nor the sublicensee has current plans to develop or distribute products containing the Kinetin concentration in the future. As a result, we recorded an impairment charge of $0.5 million consisting of the unamortized net book value of the initial license fee and the obligation for additional payments for which there is no future benefit. These charges were recorded as a component of "Selling, general and administrative expense."

Litigation settlement and insurance coverage. In January 2010, Dr. Zein Obagi, ZO Skin Health, Inc., and related parties filed a complaint and an arbitration demand against us. We later filed counterclaims in both proceedings. On May 2, 2011, the parties to both proceedings entered into a Settlement Agreement that requires dismissal of all claims and counterclaims in both proceedings. Pursuant to the Settlement Agreement, we have made a one-time settlement payment of $5.0 million. The Settlement Agreement also contains a number of non-economic terms. See Note 7 in Notes to Unaudited Condensed Consolidated Financial Statements for further discussion on the litigation and the Settlement Agreement. Since January 2010 through March 31, 2011, we have incurred significant litigation and related fees, including the $5.0 million settlement, of $12.7 million. During the three months ended March 31, 2011, we


received a coverage letter from our primary general liability insurance carrier, agreeing to defend the lawsuit, under a reservation of rights. At present, we are not aware of the amount of litigation costs and settlement fees we may recover as we are currently in discussions with the insurance carrier. As a result, we currently cannot estimate the amount, if any, that the insurance carrier will agree to pay.

Texas regulatory matter. In November 2009, we received a letter from the Agency regarding our shipping in Texas of products containing unapproved new drugs and, specifically, referencing certain retail businesses in Texas that were selling our products containing prescription drugs over the Internet. Prior to this time, the Agency had detained products from three of our customers that sold products on the Internet. In its letter, the Agency alleged that we were shipping unapproved new drug articles to these establishments in violation of certain Texas statutes. We submitted our response to the Agency in January 2010 indicating why we believed we were in compliance with the Texas statutes. In May 2010, the Agency sent us a letter indicating that it did not agree with the arguments set forth in our January 2010 letter. In June 2010, we had an in-person meeting with officials from the Agency to further discuss its concerns. In August 2010, we submitted additional written information to the Agency in response to the topics discussed and additional information requested by the Agency at the June meeting. From that time until April 2011, the Agency did not have any further communication with us. In March 2011, the Agency, in response to what we currently understand was a new complaint, detained our products containing 4% hydroquinone from one of our customers as being unapproved new drugs and further cited this customer for dispensing prescription drugs without a pharmacy license in violation of various Texas statutes. During the week of April 4, 2011, the Agency detained products from several more of our customers citing similar violations. Between April 7 and April 15, 2011, we attempted to contact the Agency to ascertain what the issues were that prompted the recent actions taken by the Agency against these customers. On April 15, 2011, the Agency indicated to us that it had referred the matter to the Texas Attorney General's office for enforcement action. On April 27, 2011, we met with the Agency and the Attorney General's office at which time the Attorney General stated it viewed us to be in violation of the Texas Food, Drug and Cosmetic Act and the Texas Deceptive Trade Practices Act arising from the sale in Texas of our products containing 4% hydroquinone, which the state believes to be an unapproved new drug. We are vigorously contesting the allegations and are engaged in preliminary discussions with the Texas Attorney General to attempt to resolve the matter cooperatively. At this time, no lawsuit has been filed by the Attorney General and no monetary penalties or other proposed disciplinary action or regulatory actions have been instituted against us. However, we have voluntarily ceased shipping any products containing 4% hydroquinone into the state of Texas. In addition, we are in the process of developing a plan that will enable our customers in Texas to return any of these products (that have not otherwise been detained) currently in their possession in exchange for a credit or refund and are working with the State of Texas to allow those customers with detained products to ship them to a central location for destruction. We have also asked the Attorney General's office to provide us with copies of the recent complaints that gave rise to the product detentions in March and April 2011. Our inability to ship our products containing 4% hydroquinone into the state of Texas for an extended period of time could have a material adverse impact on our consolidated financial position, results of operations and cash flows. Texas net sales, including products containing hydroquinone, represented approximately 8.8% of our total net sales during the year ended December 31, 2010.

In light of the aforementioned events, we recorded a sales returns and allowances provision for product to be returned from our customers residing in Texas. The sales returns and allowances provision of $1.9 million was recorded as a component of "Accrued liabilities" as of March 31, 2011 (see Note 2 to Unaudited Condensed Consolidated Financial Statements) and as an offset to "Net sales" during the three months ended March 31, 2011. In addition, we recorded $0.3 million in estimated finished goods inventory to be returned as of March 31, 2011 and as an offset to "Cost of sales" during the three months ended March 31, 2011. Our methodology for calculating the provision considers, by customer, the previous 12 months of sales history. This estimate for returns will be adjusted on a quarterly basis based upon actual and historical rates of returns and other related factors.

As discussed above, we are engaged in discussions with the Texas Attorney General. Although no formal enforcement action has been instituted against us, it is possible that penalties may be assessed and significant legal costs will be incurred in resolving this matter. Based on the early stage of these discussions, it is neither possible to accurately predict the ultimate resolution nor can we reasonably estimate any potential penalties and expenses. These penalties and expenses may be material, and could have a material adverse effect on our consolidated financial position, results of operations and cash flows.

Exit of Manufacturing Facility. In 2005, we established a manufacturing facility in Milford, Connecticut to develop the ability to manage and protect the manufacturing process with respect to certain of our products. This facility is used solely for the purpose of small-scale manufacturing in connection with new product technologies and smaller market introduction quantities. We currently perform part of the manufacturing process for the CLENZIderm M.D. System in this facility. During the three months ended March 31, 2011, we decided to transfer the production to third-party manufacturers, with full protection of the related intellectual property, and to exit this manufacturing facility by July 31, 2011.


During the three months ended March 31, 2011, we recorded charges approximating $0.1 million related to the exit, which includes lease termination costs, one-time employee termination charges and accelerated depreciation expense. We expect total costs to exit the manufacturing facility, including the charges recorded as of March 31, 2011, to approximate $0.2 million.

Results of operations. We commenced operations in 1997, and as of March 31, 2011, we had accumulated earnings of $24.9 million. We reported net loss of $2.4 million and net income of $1.9 million for the three months ended March 31, 2011 and 2010, respectively.

Seasonality. Sales of our products have historically been higher between September and March of each year. We believe this is due to increased product use and patient compliance during these months. We believe this increased usage and compliance relates to several factors such as higher patient tendencies toward daily compliance inversely proportionate to their tendency to travel and/or engage in other disruptive activities during summer months. Patient travel and other disruptive activities that affect compliance are at their peak during July and August. The effects of seasonality in the past have been offset by the launch of new products. This trend was very pronounced during 2007 when we launched four new product offerings and rebranded two systems. However, we cannot assure you that we will continue to be able to offset such seasonality in the future.

Economy. Many treatments in which our products are used are considered cosmetic in nature, are typically paid for by the patient out of disposable income and are generally not subject to reimbursement by third-party payors such as health insurance organizations. As a result, we believe that our current and future sales growth may be influenced by the economic conditions within the geographic markets in which we sell our products. Although there are modest signs of economic recovery, it is unclear whether the economy will show sustained growth and/or stability. Accordingly, we cannot assure you that the improvement in revenue growth that we experienced in the last six quarters will be sustainable. Even with continued growth in many of our markets during this period, the recent recession could adversely impact our business in the future causing a decline in demand for our products, particularly if uncertain economic conditions are prolonged or worsen. We do believe that some of the negative impact experienced during the majority of 2009 was partially offset due to the following: (i) we are the leader in the physician-dispensed market; (ii) the aesthetic nature of our products; (iii) the lower price point of our products compared to other aesthetic products in our market; (iv) the desire to maintain a healthy and youthful appearance; and (v) the demographics of the patients who use our products.

Future growth. We believe that our future growth will be driven by increased direct sales coverage, penetration into non-core markets such as other medical specialties, ongoing marketing efforts to create increased awareness of the Obagi brand and the benefits of skin health and new product offerings. We plan to continue to invest resources on the commercialization of new applications of our current products, the continuing development of our pipeline of products and the in licensing or acquisition of new product opportunities. However, our current business plan does not anticipate that we invest significant resources in these strategic initiatives over the near term. As a result, we believe that our ongoing profitability is primarily dependent upon the continued success of our current product offerings and certain other strategic marketing initiatives. We may begin to invest significant resources to facilitate our growth once we see sustained stability in the global markets.

Critical accounting policies and use of estimates

Our discussion and analysis of our financial condition and results of operations is based upon our Unaudited Condensed Consolidated Financial Statements, which have been prepared in accordance with U.S. GAAP. The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, sales and expenses, and disclosures of contingent assets and liabilities at the date of the financial statements. On a periodic basis, we evaluate our estimates, including those related to revenue recognition, sales return reserve, accounts receivable, inventory, goodwill and other intangible assets. We use historical experience and other assumptions as the basis for making estimates. By their nature, these estimates are subject to an inherent degree of uncertainty. As a result, we cannot assure you that future actual results will not differ significantly from estimated results.

We believe that the estimates, assumptions and judgments involved in revenue recognition, sales returns and allowances, accounts receivable, inventory, goodwill and intangible assets, stock-based compensation and accounting for income taxes have the greatest potential impact on our Unaudited Condensed Consolidated Financial Statements, so we consider these to be our critical accounting policies. Historically, our estimates, assumptions and judgments relative to our critical accounting policies have not differed materially from actual results. However, it is possible that the actual results we experience may differ materially and adversely from our estimates in the future. There have been no material changes to the critical accounting estimates associated with these policies as described in Part II, Item 7 "Management's


Discussion and Analysis of Financial Condition and Results of Operations" of our 2010 Annual Report on Form 10-K filed with the SEC on March 11, 2011, other than as set forth below.

Sales returns and allowances. When we sell our products we reduce the amount of revenue recognized from such sales by an estimate of future product returns and other sales allowances. Sales allowances include cash discounts, rebates and sales incentives relating to products sold in the current period. Factors that are considered in our estimates of sales returns include the historical rate of returns as a percentage of net product sales, gross of returns and allowances and shipping and handling revenue, historical aging of returns and the current market conditions. Although our domestic sales agreements do not provide for a contractual right of return, we maintain a return policy that allows our customers to return product within a specified period after shipment of the product has occurred. Factors that are considered in our estimates regarding sales allowances include quality of product and recent promotional activity.

As discussed earlier, in April 2011, we were made aware of enforcement actions taken against certain of our customers by the Agency and the Texas Attorney General regarding the shipping of our products containing 4% hydroquinone, into the state of Texas. As a result of these actions, we have voluntarily ceased shipping any products containing 4% hydroquinone in the state of Texas. We are in the process of developing a plan that will enable our customers residing in Texas to return any of these products (that have not otherwise been detained) currently in their possession in exchange for credit or refund. During the three months ended March 31, 2011, we recorded a sales returns and allowances provision related to this matter of $1.9 million as a component of "Accrued liabilities" and as an offset to "Net sales." In addition, we recorded $0.3 million in estimated finished goods inventory to be returned as of March 31, 2011 and as an offset to "Cost of sales" during the three months ended March 31, 2011. Our methodology for calculating the provision considers, by customer, the previous 12 months of sales history. This estimate for returns will be adjusted on a quarterly basis based upon actual and historical rates of returns and other related factors.

If actual future experience for product returns and other sales allowances exceeds the estimates we made at the time of sale, our financial position, results of operations and cash flow would be negatively impacted. To date, such provisions have approximated management's estimates.

Results of operations

The three months ended March 31, 2011 compared to the three months ended March 31, 2010

Net sales. The following table compares net sales by product line and certain selected products for the three months ended March 31, 2011 and 2010.

Three Months Ended March 31, 2011 2010 Change

(in thousands)

Net Sales by Product Category:
Physician-dispensed
Nu-Derm               $       13,174       $       12,858            2 %
Vitamin C                      3,565                4,012          -11 %
Elasticity                     3,060                2,772           10 %
Therapeutic                    1,274                1,615          -21 %
Other                          3,865                3,460           12 %
Total                         24,938               24,717            1 %
Licensing fees                 1,575                  989           59 %
Total net sales       $       26,513       $       25,706            3 %

United States                     82 %                 85 %
International                     18 %                 15 %

Net sales increased by $0.8 million to $26.5 million during the three months ended March 31, 2011, as compared to $25.7 million during the three months ended March 31, 2010. Overall, we believe our growth during the three months ended March 31, 2011 is primarily due to a larger base of active accounts, higher level of patient visits due to increased consumer confidence versus last year, international growth in both physician-dispensed and licensing and the launch of new products. This growth, however, was offset by the $1.9 million sales returns and allowances provision recorded during the three months ended March 31, 2011, related to the actions brought by the Texas state regulatory bodies (see "Overview and Recent Developments" above for further discussion) in April 2011.


Physician-dispensed sales increased $0.2 million, to $25.0 million during the . . .

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