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DEPO > SEC Filings for DEPO > Form 10-Q on 7-Nov-2008All Recent SEC Filings

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Form 10-Q for DEPOMED INC


7-Nov-2008

Quarterly Report


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

FORWARD-LOOKING INFORMATION

Statements made in this "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this Quarterly Report on Form 10-Q that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, those relating to:

† our ability to find development and commercialization partners for DM-1796 and DM-5689 (both formerly referred to as Gabapentin GR®) and other product candidates;

† results and timing of our clinical trials, including the results of our DM-1796 and DM-5689 trials;

† the commercial success and market acceptance of GLUMETZA® (metformin hydrochloride extended release tablets) in the United States;

† the efforts of Santarus, Inc. with respect to the commercialization of GLUMETZA;

† the results of our internal research and development efforts;

† acceptance and approval of regulatory filings;

† our need for, and ability to raise, additional capital;

† market acceptance of Proquin® XR (ciprofloxacin hydrochloride extended release tablets);

† the efforts of Watson Pharmaceuticals with respect to the commercialization of Proquin XR;

† our collaborative partners' compliance or non-compliance with their obligations under our agreements with them; and

† our plans to develop other product candidates.

Factors that could cause actual results or conditions to differ from those anticipated by these and other forward-looking statements include those more fully described in the "RISK FACTORS" section and elsewhere in this Quarterly Report on Form 10-Q. We disclaim any intent to update or revise these forward-looking statements to reflect new events or circumstances.

ABOUT DEPOMED

Depomed is a specialty pharmaceutical company focused on the development and commercialization of differentiated products that address large and growing markets and are based on proprietary oral drug delivery technologies. In 2004, we announced our determination to evolve from a solely product development focused company to an integrated specialty pharmaceutical company, with sales and marketing of our own products. Preliminary staffing for these activities began in 2005. In 2006 and 2007, we enhanced our internal sales and marketing capabilities through the hiring of additional sales and marketing employees and the engagement of consultants.

We have developed two commercial products. GLUMETZA®(metformin hydrochloride extended release tablets) is a once-daily treatment for adults with type 2 diabetes that we commercialize in the United States with Santarus, Inc.
(Santarus). Proquin® XR (ciprofloxacin hydrochloride extended release tablets)
is a once-daily treatment for uncomplicated urinary tract infections that we commercialize in the United States with Watson Pharma (Watson).

We have a three-pronged approach to product development designed to optimize the use and value of our drug delivery technologies, while managing the costs and risks associated with developing and commercializing pharmaceutical products. We develop products for our own account that are designed to compete in large growing markets and that can be highly


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differentiated from immediate release versions of the compounds upon which they are based. Second, we selectively enter into collaborative partnerships with other companies where the unique capabilities of our technology can provide superior value to a partner's compound, resulting in significantly greater value for Depomed than a traditional fee-for-service arrangement. Third, we enter into arrangements that enable our technology to be applied by other companies to a greater number of compounds than our infrastructure can support, so as to derive additional value from our technology. In the future, we plan to commercialize our proprietary products, relying on partners to cover the large primary care audiences, while maintaining co-promotion and distribution rights in order to be in a position to create our own sales force when appropriate, thereby increasing the value to us of our products, and our control over them.

Our most advanced product candidates in development are DM-1796 and DM-5689 (both formerly referred to as Gabapentin GR), extended release forms of gabapentin. We have initiated two Phase 3 trials with respect to DM-5689 for the treatment of menopausal hot flashes. We have also completed a Phase 3 clinical trial with respect to DM-1796 for the treatment of postherpetic neuralgia (PHN), and have initiated a second Phase 3 trial for the same indication. In addition, we have other product candidates in earlier stages of development.

The following table summarizes our marketed products, and our product pipeline.

                                Marketed Products

Product                        Indication                      Status

GLUMETZA®               Type 2 diabetes            Currently sold in the United
                                                   States, Canada and Korea.
                                                   Co-promoted in the US with
                                                   Santarus beginning in
                                                   October 2008.
                                                   Canadian rights held by
                                                   Biovail.
                                                   Korean rights held by LG Life
                                                   Sciences.

Proquin® XR             Uncomplicated urinary      Currently sold in the United
                        tract infection            States.
                                                   Co-promoted in the US with
                                                   Watson Pharma.

                                                   Regulatory application
                                                   approved in Sweden. European
                                                   rights held by
                                                   Rottapharm/Madaus.

                                Product Pipeline

DM-1796                 Postherpetic neuralgia     Second Phase 3 study underway.
Formerly referred to
as Gabapentin GR®

DM-5689                 Menopausal hot flashes     Phase 3 studies underway
Formerly referred to                               (Breeze 1 and Breeze 2).
as Gabapentin GR®

DM-3458                 Gastroesophageal reflux    Proof of concept studies
Formerly referred to    disease                    completed.
as Omeprazole

DM-1992                 Parkinson's disease        Preclinical development
Formerly referred to                               ongoing.
as Levodopa/Carbidopa

One undisclosed         Confidential               Preclinical development
compound                                           ongoing.

Our intellectual property position includes twelve issued patents and sixteen patent applications pending in the United States.


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Significant Developments for the Quarter Ended September 30, 2008.

† In September 2008, we enrolled and dosed the first patient in Breeze 1, the first of two pivotal Phase 3 clinical trials in our registration program for DM-5689 for the treatment of menopausal hot flashes.

† In July 2008, we entered into a promotion agreement with Santarus, Inc. (Santarus) granting Santarus exclusive rights to promote GLUMETZA in the United States, and we received a $12 million upfront fee from Santarus.

† In July 2008, we were awarded a modest preclinical grant by The Michael J. Fox Foundation under the foundation's Therapeutics Development Initiative 2008 Program related to our DM-1992 program.

† In July 2008, the Medical Products Agency in Sweden approved the Marketing Authorization for Proquin XR, which is licensed by Rottapharm/Madaus in Europe.

† In July 2008, we drew an additional $5.6 million under our credit facility with General Electric Credit Company and Oxford Finance Corporation.

† Revenue for the three months ended September 30, 2008 was $14.1 million, compared to $52.9 million for the three months ended September 30, 2007. Revenue for the three months ended September 30, 2008 included a one-time increase of $6.3 million in product sales related to previously deferred revenue, net of estimated product returns, contractual allowances and discounts. Revenue for the three months ended September 30, 2007 included a one-time recognition of $48.6 million associated with the termination of our Esprit Pharma license and supply agreements.

† Operating expenses for the three months ended September 30, 2008 were $12.2 million compared to $8.2 million for the three months ended September 30, 2007. Operating expenses for the three months ended September 30, 2007 included a one-time gain of $5.0 million related to the termination of our agreements with Esprit Pharma, which had the effect of reducing operating expenses for that period.

† Cash, cash equivalents and marketable securities were $85.5 million as of September 30, 2008 compared to $69.5 million as of December 31, 2007.

RECENT PRODUCT DEVELOPMENTS

MARKETED PRODUCTS

GLUMETZA®

Santarus, Inc. In July 2008, we entered into a promotion agreement with Santarus granting Santarus exclusive rights to promote GLUMETZA in the United States. Santarus paid us a $12.0 million upfront fee, and based on the achievement of specified levels of annual GLUMETZA net product sales, Santarus may be required to pay us additional one-time sales milestones, totaling up to $16.0 million.

Santarus began promotion of GLUMETZA in October 2008. Santarus is required to meet certain minimum promotion obligations during the term of the agreement, and required to make certain minimum marketing, advertising, medical affairs and other commercial support expenditures. We will continue to record revenue from the sales of GLUMETZA product and, beginning in the fourth quarter of 2008, will pay Santarus a fee ranging from 75% to 80% of the gross margin earned from net sales of GLUMETZA product in the United States.

Santarus is responsible for all costs associated with its sales force and for all other marketing expenses associated with its promotion of GLUMETZA product. We are responsible for overseeing product manufacturing and supply. A joint commercialization committee has been formed to oversee and guide the strategic direction of the GLUMETZA alliance.

Pursuant to the terms of the promotion agreement, we retain the option to co-promote GLUMETZA product in the future to obstetricians and gynecologists. The promotion agreement will continue in effect until the expiration of the last-to-expire patent or patent application with a valid claim in the territory covering a GLUMETZA product, unless terminated sooner.

Contract Sales Organization. In February 2008, we entered into a professional detailing services agreement with Publicis Selling Services (Publicis) pursuant to which approximately 33 part-time Publicis sales representatives detailed GLUMETZA to physicians. The arrangement with Publicis ended in September 2008.

1000mg Formulation. In December 2007, the FDA approved the 1000mg formulation for marketing in the United States. In June 2008, we began selling the 1000mg GLUMETZA.


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Proquin® XR

Rottapharm/Madaus. In November 2005, we entered into a distribution and supply agreement for Proquin XR in Europe with a privately owned specialty pharmaceutical company, Madaus S.r.l., that was acquired by Rottapharm in June 2007. Under the terms of the agreement, we granted an exclusive right to Madaus for the commercialization of Proquin XR in Europe and agreed to supply Madaus with commercial quantities of Proquin XR tablets in bulk form. In March 2006, Madaus filed a Marketing Authorization Application for Proquin XR with the Medical Products Agency in Sweden. In July 2008, the Medical Products Agency in Sweden approved the Marketing Authorization. We received a $0.3 million advance payment from Rottapharm for supply of future product in August 2008.

PRODUCT CANDIDATES

DM-1796 (formerly known as Gabapentin GR) for Postherpetic Neuralgia

In March 2008, we initiated dosing of the first patient in a second Phase 3 clinical trial for DM-1796 for PHN. The study is a randomized, double-blind, placebo-controlled study of approximately 450 PHN patients. Patients in the study are randomized into two treatment arms: placebo, or 1800mg of DM-1796 dosed once daily. The study is being conducted at sites in the United States and Russia.

The primary objective of the study is to assess the efficacy of DM-1796 in reducing the pain associated with PHN, measured from baseline pain scores to the end of a ten-week treatment period on the basis of the Likert pain scale. Secondary objectives include an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.

The primary differences in the ongoing study relative to the Phase 3 PHN study we concluded in 2007 are: (a) there is only one active treatment arm (1800 mg once daily) rather than two; and (b) patients enrolled in the study must have "stable PHN disease" for at least six months, rather than three months, following healing of the shingles rash.

DM-5689 (formerly known as Gabapentin GR) for Menopausal Hot Flashes

In February 2008, we announced positive results of our Phase 2 trial for DM-5689 for moderate-to-severe menopausal hot flashes.

Phase 2 Study. In June 2007, we randomized the first patient in a Phase 2 double-blind, placebo-controlled, multi-center trial evaluating DM-5689 for the treatment of women with moderate-to-severe menopausal hot flashes. The 124 patient study was fully enrolled in September 2007.

Study Design. The study included 124 menopausal women (approximately 30 per group) with recurrent, moderate to severe hot flashes and was conducted at eight sites in the United States. The total study treatment duration after screening and baseline was 13 weeks. The primary objective of the study was to investigate the relationship between blood plasma concentrations of gabapentin observed in menopausal women after administration of DM-5689 and the frequency of hot flashes in those women. The plasma concentration data (pharmacokinetics) and the hot flash frequency and severity data (pharmacodynamics) are being used to construct a PK/PD dose response model designed to identify the dosing regimen to utilize in the Phase 3 program.

In order to facilitate the generation of an optimal dose response model, patients in each of the three active treatment arms remained on a stable DM-5689 dose for five weeks at an initial dose, followed by five weeks on a stable, incrementally higher dose, as follows.

         Treatment Group           Weeks 2 - 6           Weeks 8 - 12
         A ("1800mg group")         600mg PM         600mg AM + 1200mg PM
         B ("2400mg group")    600mg AM + 600mg PM   600mg AM + 1800mg PM
         C ("3000mg group")         1200mg PM        1200mg AM + 1800mg PM
         D ("placebo group")         placebo                placebo

Each stable dosing regimen was preceded by a one-week titration period


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Efficacy. DM-5689 demonstrated a reduction in the mean frequency of moderate to severe hot flashes, and in the mean total daily severity of hot flashes, in all active treatment groups. Statistical significance relative to placebo from baseline to the end of the study was observed in the 1800mg and 2400mg treatment groups with regard to frequency, and statistical significance was observed in the 1800mg treatment group with regard to severity. The severity of hot flashes is based on a mean daily composite score, where a moderate hot flash is assigned a score of "2" and a severe hot flash is assigned a score of "3". The primary efficacy outcomes observed in the study are set forth in the table below.

                     Mean Daily Frequency (#)      Mean Total Daily Severity Score
  Treatment Group   Baseline   End of treatment    Baseline       End of treatment
      1800mg          10.1     2.7 (p = 0.016)       24.0         6.4 (p = 0.022)
      2400mg          11.8      3.0 (p = 0.03)       29.6         7.9 (p = 0.063)
      3000mg          11.4     3.9 (p = 0.229)       27.8         10.2 (p = 0.334)
      placebo         10.6           5.1             26.7               12.6

Safety. DM-5689 was generally well tolerated in the study, with one, two, one and three patients, respectively, withdrawing due to adverse events from the placebo, 1800mg, 2400mg and 3000mg groups. The most common side effects observed in the study were headache, somnolence, dizziness and nausea. The incidence of those side effects in each of the treatment groups is set forth in the table below.

     Treatment Group   Somnolence (%)   Dizziness (%)   Headache (%)   Nausea (%)
         1800mg              16              10              32            16
         2400mg              16              39              32            3
         3000mg              16               9              25            3
         placebo             3               10              10            7

Phase 3 Registration Program. Our Phase 3 registration program for DM-5689 in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study, Breeze 1 and Breeze 2. In September 2008, we enrolled and dosed the first patient in Breeze 1, and in October 2008, we enrolled and dosed the first patient in Breeze 2. In each study, patients will be randomized into three treatment arms: (i) placebo;
(ii) 1200mg of DM-5689 dosed once daily; or (iii) a total dose of 1800mg of DM-5689 dosed 600mg in the morning and 1200mg in the evening.

The treatment duration of the Breeze 1 study will be six months, with primary efficacy endpoints assessed at 4 and 12 weeks. Persistence of efficacy will be assessed at 6 months as one of the secondary endpoints. The treatment duration in the second study, Breeze 2, will be three months, with assessment of efficacy at 4 and 12 weeks only.

The primary efficacy endpoints in both studies will be reductions in the mean frequency of moderate to severe hot flashes, and the average severity of hot flashes. Various secondary efficacy endpoints will be measured as well.

OTHER RESEARCH AND DEVELOPMENT AND COLLABORATIVE PROGRAMS

Supernus. In September 2006, we entered into a collaboration agreement with Supernus Pharmaceuticals, Inc. to develop through a Phase 1 study a product candidate leveraging our AcuForm drug delivery technology. The cost and ownership of the program is shared between the parties equally. The collaboration agreement includes provisions pursuant to which the parties may negotiate and enter into a definitive agreement for the further development and for commercialization, by either or both parties, of the product candidate. The feasibility phase of the collaboration was completed in April 2008 and both parties have elected not to continue to develop the product candidate.

OTHER EVENTS

Patent Lawsuit Settlement. In April 2008, we entered into a Settlement and License Agreement with Teva Pharmaceuticals USA, Inc. (collectively with its affiliates, Teva) related to the patent infringement lawsuit we filed against Teva affiliates IVAX Corporation and IVAX Pharmaceuticals, Inc. in January 2006, in which we alleged infringement of the Company's patents (US Patent Nos. 6,340,475 and 6,635,280 (the Asserted Patents)) by IVAX's extended release metformin hydrochloride tablets.


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Pursuant to the settlement Agreement: (a) the parties dismissed and released all claims associated with the litigation; (b) we received a one-time payment of $7.5 million in April 2008; (c) we granted Teva a non-exclusive license to the Asserted Patents (including IVAX) to continue to market its generic Glucophage® XR (metformin hydrochloride extended release tablets) product in the United States under the Asserted Patents; and (d) we will receive ongoing royalty payments from Teva on sales by Teva (including IVAX) of generic Glucophage XR in the United States. The royalty is subject to a $2.5 million aggregate cap.

Credit Facility. In June 2008, we entered into a $15.0 million secured credit facility with General Electric Capital Corporation (GECC) and Oxford Finance Corporation (Oxford). The credit facility is described below under "LIQUIDITY AND CAPITAL RESOURCES".

CRITICAL ACCOUNTING POLICIES

Critical accounting policies are those that require significant judgment and/or estimates by management at the time that the financial statements are prepared such that materially different results might have been reported if other assumptions had been made. We consider certain accounting policies related to revenue recognition, accrued liabilities and stock-based compensation to be critical policies. Except as described below under "Revenue Recognition" and "Stock-Based Compensation", there have been no changes to our critical accounting policies since we filed our 2007 Annual Report on Form 10-K with the Securities and Exchange Commission on March 12, 2008. For a description of our critical accounting policies, please refer to our 2007 Annual Report on Form 10-K.

Revenue Recognition

We recognize revenue from the sale of our products, license fees and royalties earned on license agreements and collaborative arrangements. Revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration received is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred and title has passed, the price is fixed or determinable and we are reasonably assured of collecting the resulting receivable.

We sell GLUMETZA product to wholesalers and retail pharmacies that is subject to rights of return within a period beginning six months prior to, and ending twelve months following product expiration. We began shipping GLUMETZA product to customers in the third quarter of 2006. Prior to the third quarter of 2008, we were unable to reasonably estimate expected returns of the product at the time of shipment, and therefore, deferred revenue on product shipments of GLUMETZA until the product was dispensed through patient prescriptions. The quantity of prescription units dispensed was estimated based on analysis of third-party information, including third-party market research data and information obtained from wholesalers with respect to inventory levels and inventory movement. Based on the shipment trends, prescription trends and product returns history for GLUMETZA over two years through the third quarter of 2008 and based on an analysis of return rates of companies with products that have similar characteristics and similar return policies within the metformin prescription market, we concluded that we had the information needed to reasonably estimate product returns during the third quarter of 2008. Beginning in the third quarter of 2008, we began recognizing revenue for GLUMETZA sales as revenue at the time of shipment to its customers. Consequently, for the quarter ended September 30, 2008, we recognized a one time increase of $6.3 million in net product sales of GLUMETZA, representing product sales previously deferred, net of estimated product returns, managed care and Medicaid rebates, wholesaler and retail pharmacy fees and discounts, chargebacks and prompt payment discounts. Deferred costs related to shipments of GLUMETZA previously deferred were also recognized to cost of sales. This change resulted in a one-time $5.3 million reduction of net loss for the third quarter of 2008. Revenues from GLUMETZA product sales are recorded net of estimated product returns, managed care rebates, wholesaler and retail pharmacy fees and discounts, prompt payment discounts, patient support programs, chargebacks, and Medicaid rebates. These gross-to-net sales adjustments are recognized in the same period the related revenue is recognized and are based on estimates of the amounts earned or to be claimed on the related sales.

We obtained the rights back from Esprit Pharma (Esprit) to market Proquin XR product in July 2007, and began selling Proquin XR to wholesalers and retail pharmacies in October 2007. Given our limited history of selling Proquin XR, we currently cannot reliably estimate expected returns of the product at the time of shipment. Accordingly, we defer recognition of revenue on product shipments of Proquin XR until the right of return no longer exists, which occurs at the earlier of the time Proquin XR units are dispensed through patient prescriptions or expiration of the right of return. We estimate patient prescriptions dispensed using an analysis of third-party information, including third-party market research data and information obtained from wholesalers with respect to inventory levels and inventory movement. We have not had significant


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history estimating the number of patient prescriptions dispensed for Proquin XR. If we underestimate or overestimate patient prescriptions dispensed for a given period, adjustments to revenue may be necessary in future periods. We have a deferred revenue balance of $1.4 million at September 30, 2008 related to Proquin XR product shipments that have not been recognized as revenue, which is net of wholesaler and retail pharmacy fees and discounts and prompt payment discounts. We will recognize revenue for Proquin XR upon the earlier of prescription units dispensed or expiration of the right of return until we can . . .

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