Depomed Reports Fourth Quarter and Full Year 2016 Financial Results

- Record Annual Revenue of $456 million in 2016 -

- Record Quarterly Revenue of $124 million in Fourth Quarter –

- Conference Call Scheduled for Today at 4:30 PM EST; Dial-In Information Below -

NEWARK, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Depomed, Inc. DEPO today reported financial results and highlighted operational achievements for the quarter and twelve months ended December 31, 2016 and provided 2017 guidance.

"In 2016, we achieved key milestones strengthening our portfolio and de-leveraging our balance sheet.  We ended the year with record annual and quarterly revenue and EBITDA. In addition, we posted all-time net sales highs for every one of our brands," said Jim Schoeneck, President and Chief Executive Officer of Depomed. "Our full-year net revenue reached $456 million, representing a 33% increase over 2015, with quarterly revenue of $124 million, an 11% increase year over year.  In addition, we have been successful in growing EBITDA from $7 million in 2014 to $111 million in 2015 and $156 million in 2016.  This, along with the early pay down of $100 million of our debt, significantly improves our credit profile and positions us well to refinance. We also built future value into the business as legal victories provided us with 9 more years to grow our flagship NUCYNTA franchise and allowed us to advance our patent infringement case against Purdue."

Continued Mr. Schoeneck, "With the clarity on NUCYNTA's exclusivity until December 2025 and the insights gained since its relaunch, in February we began implementing a multi-faceted growth initiative to increase the appropriate use of NUCYNTA Extended Release and Immediate Release and to drive growth across the portfolio. We continue to focus on opportunities to further differentiate our product portfolio, all with the goal of delivering value to our shareholders and to those we serve."

Business and Financial Highlights

• Record full year net product sales for 2016 were $455 million, an increase of 33% compared to $342 million for full year 2015
  
• Full year GAAP net loss of ($89) million or ($1.45) per share, which includes a non-cash tax reserve adjustment of ($43) million
  
• Full year non-GAAP adjusted earnings of $86 million, or $1.15 per share. We are modifying our method of calculating non-GAAP income taxes for non-GAAP adjusted earnings and non-GAAP adjusted earnings per share to align with the guidance under the Non-GAAP Financial Measures Compliance and Disclosure Interpretations issued by the SEC on May 17, 2016.  The amounts above reflect the Company's prior methodology of calculating its non-GAAP income taxes for comparability to prior periods and to the Company's prior guidance for 2016. Please see the non-GAAP tax discussion below for further discussion of the new methodology.
  
• Full year non-GAAP adjusted EBITDA of $156 million
  
• Fourth quarter 2016 net product sales were a record $124 million, compared to $111 million for fourth quarter of 2015, an increase of 11%
  
• NUCYNTA franchise reported fourth quarter record net sales of $75 million
  
• Fourth quarter ending cash and marketable securities was $177 million, cash generated during the quarter was $40 million
  
• Quarterly GAAP net loss of ($44) million or ($0.72) per share, which includes a non-cash tax reserve adjustment of ($43) million
  
• Quarterly non-GAAP adjusted earnings of $37 million, or $0.48 per share under the Company's prior method of calculating its non-GAAP income tax expense.
  
• Quarterly non-GAAP adjusted EBITDA of $51 million
  
• U.S. District Court rules in favor of two key NUCYNTA patents, providing market exclusivity until December 2025
  
• U.S. Court of Appeals upheld patents asserted against Purdue Pharma
  
• Early payment of $100 million of secured debt in April 2016

NUCYNTA® Franchise Highlights

• Full year 2016 record net sales of $281 million
  
• Fourth quarter 2016 record net sales of $75 million
  
• Net sales of $471 million since acquisition on April 2, 2015
  
• NUCYNTA ER® reached record all-time quarterly prescription volume of over 90,000 in fourth quarter¹
  
• NUCYNTA ER 2016 total prescriptions of over 344,000, an increase of 19% over 2015¹
  
• NUCYNTA ER reached record all-time quarterly market share of 2.08% of total long acting opioids in December¹
  
• NUCYNTA reached record all-time quarterly market share of 0.29% in fourth quarter¹
  

Marking a continued commitment to unlock value from its portfolio, in February, the company launched the first of a series of initiatives aimed at driving NUCYNTA growth in 2017 which include:

• Salesforce Deployment: adds 75 reps to Pain sales force for a total of 257, an increase  of 41%; Neuro and Oncology sales forces reduced by 70 positions to offset increase; new physician targeting emphasizes reimbursement coverage along with prescription volume  
  
• Primary Care Physician Expansion: new salesforce deployment targets more coverage of high decile primary care prescribers
  
• NUCYNTA ER Diabetic Peripheral Neuropathy (DPN) Indication: highlights indication in category unique to NUCYNTA ER
  
• NUCYNTA Immediate Release Promotion: introduces a focused, stand-alone promotional campaign for the first time since relaunch
  
• NUCYNTA Label Expansion Studies: initiating studies aimed at strengthening NUCYNTA's respiratory depression and abuse profiles
  

Other Product Portfolio Highlights

• Gralise® full-year net sales were $88 million, an increase of 9% compared to $81 million in 2015, fourth quarter net sales were $25 million, an increase of 15% compared to $22 million in the same period last year
   
• Cambia® full-year net sales were $31 million, an increase of 14% compared to $27 million in 2015, fourth quarter 2016 net sales were $8.4 million, an increase of 3% compared to $8.2 million in the same period last year
  
  -Introduction of an aspartame-free formulation of CAMBIA for the treatment of migraine
  
  
• Lazanda® full-year net sales were $27 million, an increase of 50% compared to $18 million in 2015, fourth quarter net sales were $7.5 million, an increase of 42% compared to $5.2 million in the same period last year and record all-time market share of 4.5% in December¹
  
  -Introduction of a 300 mcg dose strength of Lazanda for the treatment of breakthrough cancer pain 
  
  
• Zipsor® full-year net sales were $28 million, an increase of 7% compared to $26 million in 2015, fourth quarter net sales were $8.2 million, an increase of 6% compared to $7.7 million in the same period last year

¹ Source: SHA IDV

Change in Non-GAAP taxes

We are modifying our method of calculating non-GAAP income tax expense for non-GAAP adjusted earnings and non-GAAP adjusted earnings per share to align with the guidance under the Non-GAAP Financial Measures Compliance and Disclosure Interpretations issued by the SEC on May 17, 2016. This new methodology, which the Company will use exclusively beginning in first quarter of 2017, calculates non-GAAP tax expense (benefit) by adjusting the GAAP tax expense (benefit) for the estimated tax impact of each non-GAAP adjustment.  The estimated tax impact is based on the statutory income tax rate for each non-GAAP adjustment.  Previously, we adjusted the non-GAAP tax expense (benefit) to reflect the estimated amount we expected to pay or receive in taxes for the period.

The following tables show the calculation of non-GAAP adjusted earnings and non-GAAP adjusted earnings per share under both the prior and new methodologies for each of the quarters of 2015 and 2016.

Valuation Allowance on Deferred Tax Assets

The Company recorded a $43 million GAAP tax expense charge related to the establishment of a reserve against the Company's deferred tax assets during the fourth quarter of 2016.   This charge has no effect on the Company's cash flows or non-GAAP financial measures and could reverse in future periods.

2017 Financial Outlook

As of February 21, 2017, Depomed is providing its financial outlook for total revenue, non-GAAP adjusted EBITDA, non-GAAP SG&A expense, and non-GAAP R&D expense for the full year 2017: 

The Company is not providing GAAP net loss or GAAP expense guidance as the Company is not able to estimate its non-recurring expenses for 2017.

Non-GAAP Financial Measures

To supplement our financial results presented on a U.S. generally accepted accounting principles, or GAAP, basis, we have included information about non‑GAAP adjusted earnings, non‑GAAP adjusted earnings per share and non-GAAP adjusted EBITDA, non‑GAAP financial measures, as useful operating metrics. We believe that the presentation of these non‑GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and our management in assessing the Company's performance and results from period to period. We use these non‑GAAP measures internally to understand, manage and evaluate the Company's performance, and in part, in the determination of bonuses for executive officers and employees. These non‑GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non‑GAAP adjusted earnings and non‑GAAP adjusted earnings per share are not based on any standardized methodology prescribed by GAAP and represent GAAP net income (loss) and GAAP earnings (loss) per share adjusted to exclude amortization, IPR&D and non‑cash adjustments related to product acquisitions, stock‑based compensation expense, non‑cash interest expense related to debt, costs associated with the Company's defense against the Horizon Pharma hostile takeover bid in 2015 and the special meeting requests made by an activist investor in 2016, adjustments associated with legal settlements, and to adjust for the tax effect related to each of the non-GAAP adjustments (new methodology) or to adjust for the income tax provision to reflect the estimated amounts payable or receivable in cash (prior methodology). Non‑GAAP adjusted EBITDA is not based on any standardized methodology prescribed by GAAP and represents GAAP net income (loss) adjusted to exclude interest income, interest expense, amortization, IPR&D and non‑cash adjustments related to product acquisitions, stock‑based compensation expense, depreciation, taxes, adjustments related to legal settlements, costs associated with the our defense against the Horizon Pharma hostile takeover bid in 2015 and the special meeting requests made by an activist investor in 2016, and transaction costs associated with product acquisitions. Non‑GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, non‑GAAP measures used by other companies.

Conference Call

Depomed will host a conference call today, Tuesday, February 21^st, beginning at 4:30 p.m. EST (1:30 p.m. PST) to discuss its results. Participants can access the call by dialing (866) 643-3010 (United States) or (857) 270-6032 (international) referencing Conference ID 71033060.  The conference call will also be available via a live webcast on the Investor Relations section of Depomed's website at http://www.Depomed.com. Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.

INVESTOR AND MEDIA CONTACT:

Christopher Keenan
VP, Investor Relations and Corporate Communications
510-744-8000
ckeenan@depomed.com