- Second Quarter Revenues of $117 million, 23% over 2Q 2015 - - NUCYNTA® Franchise Second Quarter 2016 Record Net Sales of $72 million, 27% over 2Q 2015 - - Conference Call Scheduled for Today at 4:30 PM EDT; Dial In Information Below -
NEWARK, Calif., Aug. 03, 2016 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq: DEPO ) today reported financial results and highlighted operational achievements for the quarter ended June 30, 2016.
"The second quarter marked the 1-year anniversary of the mid-June relaunch of our flagship NUCYNTA franchise,” said Jim Schoeneck, President and CEO of Depomed. “During the first full year after our relaunch, we delivered $274 million of total NUCYNTA net sales, an increase of 59% over the final year of sales under the previous owner. NUCYNTA ER prescriptions continued to accelerate in June, up 26% over the prior year and achieving all-time high prescription volume and market share. And this is against a backdrop of challenging opioid market conditions that see declining prescriptions for the overall market and other leading brands. We are also encouraged by the positive NUCYNTA IR trends, with May and June showing a 2% prescription volume increase year-over-year, reversing the 10% decline seen before our re-launch. We believe that our flagship franchise is well-positioned for continued growth. The rest of our portfolio also performed well, delivering $45 million in combined revenues, with record quarterly revenues from both Gralise and Lazanda. Going forward we remain focused on growing our highly-differentiated portfolio and delivering value to all the groups we serve.”
Business and Financial Highlights
- Second quarter 2016 revenues were $117 million, compared to $95 million for second quarter of 2015, a 23% increase
- Second quarter NUCYNTA® franchise revenue $72 million, compared to $57 million for second quarter of 2015, a 27% increase
- Quarterly net loss of ($10.5) million or ($0.17) per share
- Quarterly non-GAAP adjusted earnings of $19.8 million, or $0.27 per share
- Quarterly non-GAAP adjusted EBITDA of $42.3 million
- Favorable Patent Office (PTAB) decision denying IPR patent challenge filed by Rosellini Scientific, LLC, ending the PTAB review relating to the NUCYNTA polymorph patent that expires in 2025
- Extension of stay by District Court in NUCYNTA ANDA Litigation with a decision expected no later than September 30, 2016
NUCYNTA Franchise Highlights
NUCYNTA and NUCYNTA ER
- Second quarter 2016 net sales of $72 million
- Net sales of $331 million since acquisition on April 2, 2015
- NUCYNTA ER record all-time monthly high prescription volume of over 29,000 reached in June 1
- NUCYNTA ER record all-time monthly high market share of long acting opioid market of 1.91% reached in June 1
- NUCYNTA ER June year-over-year prescription growth of 26% 1
- First NUCYNTA IR year-over-year quarterly prescription growth since 2011 1
- NUCYNTA IR May and June year-over-year prescription growth of 2% 1
Product Portfolio Highlights
- Gralise® second quarter 2016 net sales were a record $23.8 million, an increase of 14% compared to $20.9 million in the same period last year
- Cambia® second quarter 2016 net sales were $7.6 million, an increase of 11% compared to $6.8 million in the same period last year
- Lazanda® second quarter 2016 net sales were a record $6.4 million, an increase of 65% compared to $3.9 million in the same period last year
1 Source: SHA IDV
| REVENUES (GAAP BASIS) | ||||||||||||||||
| (in thousands, unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Product sales, net: | ||||||||||||||||
| Nucynta products (1) | $ | 71,917 | $ | 56,653 | $ | 141,281 | $ | 56,653 | ||||||||
| Gralise | 23,788 | 20,927 | 42,811 | 38,201 | ||||||||||||
| Cambia | 7,618 | 6,848 | 13,790 | 12,213 | ||||||||||||
| Lazanda | 6,352 | 3,853 | 10,912 | 7,038 | ||||||||||||
| Zipsor | 6,842 | 6,014 | 12,294 | 11,861 | ||||||||||||
| Total product sales, net | 116,517 | 94,295 | 221,088 | 125,966 | ||||||||||||
| Royalties | 165 | 209 | 374 | 742 | ||||||||||||
| Total revenues (GAAP Basis) | $ | 116,682 | $ | 94,504 | $ | 221,462 | $ | 126,708 | ||||||||
| (1) Nucynta acquisition closed in April 2015 | ||||||||||||||||
Updated 2016 Financial Outlook
Depomed is updating its 2016 financial guidance as follows:
| Updated Guidance | Prior Guidance | |
| Total Revenue | $480 to $505 million | $490 to $520 million |
| Non-GAAP SG&A Expense | $185 to $190 million | $185 to $195 million |
| Non-GAAP R&D Expense | $28 to $35 million | $28 to $35 million |
| Non-GAAP Adjusted Earnings | $95 to $105 million | $95 to $115 million |
| Non-GAAP Adjusted EBITDA | $175 to $190 million | $175 to $205 million |
The Company is not providing GAAP net loss or GAAP expense guidance as the Company is not able to estimate its non-recurring costs for the remainder of 2016.
Non-GAAP Financial Measures
In this press release, Depomed includes 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 for the three month and six periods ended June 30, 2016 and 2015 and its full year 2016 financial outlook.
The Company believes that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provides relevant and useful supplementary information to analysts, investors, lenders, and our management in assessing the Company’s performance and liquidity. The Company uses these non-GAAP financial measures in connection with its own planning and forecasting purposes, and in part, in the determination of bonuses for executive officer and employees.
The Company uses non-GAAP adjusted earnings and non-GAAP adjusted earnings per share to evaluate its period-over-period operating performance because it provides supplementary information on the results of the primary operations of the Company that more consistently correlates with the Company’s underlying operating cash flows of the business by removing non-cash gains or losses and non-recurring cash gains or losses. This measure may also be useful to investors and analysts in evaluating the underlying operating performance of the business.
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 loss and GAAP net loss per share adjusted to exclude (1) amortization and non-cash adjustments related to product acquisitions, (2) non-cash stock-based compensation expense, (3) non-cash interest expense related to debt, (4) non-recurring costs associated with the Company's defense against the Horizon Pharma hostile takeover bid in 2015 and costs associated with the special meeting requests made by an activist investor in 2016, and by excluding (5) the non-cash portion of income tax benefit/expense related to the period.
The Company uses non-GAAP adjusted EBITDA to evaluate its period-over-period operating performance because it provides supplementary information on the results of the primary operations of the Company before investing and financing income and expense and taxes. This measure may be useful to lenders and other parties to evaluate our credit worthiness. This measure may also be useful to investors and analysts in evaluating the underlying operating performance of the business.
Non-GAAP adjusted EBITDA is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude (1) amortization and non-cash adjustments related to product acquisitions, (2) non-cash stock-based compensation expense, (3) depreciation, (4) taxes, (5) non-recurring costs associated with the Company's defense against the Horizon Pharma hostile takeover bid in 2015 and costs associated with the special meeting requests made by an activist investor in 2016, (6) interest income and expense, and (7) non-recurring transaction costs associated with product acquisitions. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.
These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net loss or other financial measures calculated in accordance with GAAP.
Conference Call
Depomed will host a conference call today, Wednesday, August 3 rd , beginning at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its results. Participants can access the call by dialing (844) 839-0046 (United States) or (857) 270-6032 (International). The conference call will also be available via a live webcast under the Investor Relations section of Depomed's website at http://www.Depomed.com . 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.
About Depomed
Depomed is a leading specialty pharmaceutical company focused on enhancing the lives of the patients, families, physicians, providers and payors we serve through commercializing innovative products for pain and neurology related disorders. Depomed markets six medicines with areas of focus that include mild to severe acute pain, moderate to severe chronic pain, neuropathic pain, migraine and breakthrough cancer pain. Depomed is headquartered in Newark, California. To learn more about Depomed, visit www.depomed.com .
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the commercialization of NUCYNTA ER, NUCYNTA, Gralise, CAMBIA, Zipsor and Lazanda, Depomed's financial outlook for 2016 and expectations regarding financial results and potential business opportunities and other risks detailed in the company's Securities and Exchange Commission filings, including the company's most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result 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.
| CONSOLIDATED STATEMENTS OF OPERATIONS (GAAP BASIS) | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 116,517 | $ | 94,295 | $ | 221,088 | $ | 125,966 | ||||||||
| Royalties | 165 | 209 | 374 | 742 | ||||||||||||
| Total revenues | 116,682 | 94,504 | 221,462 | 126,708 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of sales | 20,965 | 22,865 | 44,514 | 25,977 | ||||||||||||
| Research and development expense | 7,116 | 4,714 | 13,065 | 6,572 | ||||||||||||
| Selling, general and administrative expense | 51,903 | 57,408 | 104,462 | 91,950 | ||||||||||||
| Amortization of intangible assets | 27,037 | 26,731 | 54,074 | 29,271 | ||||||||||||
| Total costs and expenses | 107,021 | 111,718 | 216,115 | 153,770 | ||||||||||||
| Income (loss) from operations | 9,661 | (17,214 | ) | 5,347 | (27,062 | ) | ||||||||||
| Other income (expense) | 67 | 61 | 197 | 118 | ||||||||||||
| Loss on prepayment of Senior Notes | (5,777 | ) | - | (5,777 | ) | - | ||||||||||
| Interest expense | (20,148 | ) | (22,078 | ) | (42,875 | ) | (28,100 | ) | ||||||||
| Benefit from (provision for) income taxes | 5,656 | 17,578 | 11,650 | 21,758 | ||||||||||||
| Net loss | $ | (10,541 | ) | $ | (21,653 | ) | $ | (31,458 | ) | $ | (33,286 | ) | ||||
| Basic and diluted net loss per share | $ | (0.17 | ) | $ | (0.36 | ) | $ | (0.52 | ) | $ | (0.56 | ) | ||||
| Shares used in calculating basic and diluted net loss per share | 61,166,044 | 59,991,934 | 61,032,155 | 59,777,594 | ||||||||||||
| CONSOLIDATED CONDENSED BALANCE SHEETS | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| June 30, | December 31, | |||||||
| 2016 | 2015 | |||||||
| Cash, cash equivalents and marketable securities | $ | 118,930 | $ | 209,768 | ||||
| Accounts receivable | 79,974 | 71,687 | ||||||
| Inventories | 10,436 | 10,494 | ||||||
| Income taxes receivable | 6,362 | 6,358 | ||||||
| Property and equipment, net | 16,194 | 14,794 | ||||||
| Intangible assets, net | 954,920 | 1,008,994 | ||||||
| Deferred tax assets | 42,189 | 22,995 | ||||||
| Prepaid and other assets | 17,072 | 12,159 | ||||||
| Total assets | $ | 1,246,077 | $ | 1,357,249 | ||||
| Accounts payable | 11,310 | 12,805 | ||||||
| Income tax payable | 6,528 | - | ||||||
| Interest payable | 15,782 | 18,672 | ||||||
| Accrued liabilities | 61,408 | 62,931 | ||||||
| Accrued rebates, returns and discounts | 117,807 | 121,058 | ||||||
| Senior notes | 464,872 | 563,012 | ||||||
| Convertible notes | 244,856 | 237,313 | ||||||
| Contingent consideration liability | 14,898 | 14,971 | ||||||
| Other liabilities | 11,514 | 11,432 | ||||||
| Shareholders’ equity | 297,102 | 315,055 | ||||||
| Total liabilities and shareholders’ equity | $ | 1,246,077 | $ | 1,357,249 | ||||
| RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EARNINGS | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| GAAP net loss | $ | (10,541 | ) | $ | (21,653 | ) | $ | (31,458 | ) | $ | (33,286 | ) | ||||
| Non-cash interest expense on debt | 5,166 | 3,984 | 9,401 | 7,405 | ||||||||||||
| Intangible amortization related to product acquisitions | 27,037 | 26,731 | 54,074 | 29,271 | ||||||||||||
| Inventory step-up related to product acquisitions | 5 | 5,057 | 16 | 5,202 | ||||||||||||
| Product sales benefit related to product acquisitions | - | 10,466 | - | 10,466 | ||||||||||||
| Contingent consideration related to product acquisitions | 490 | (797 | ) | 907 | (1,895 | ) | ||||||||||
| Stock based compensation | 4,328 | 3,253 | 8,238 | 6,066 | ||||||||||||
| Non-cash income tax adjustment | (7,447 | ) | (7,036 | ) | (14,461 | ) | (11,216 | ) | ||||||||
| Other costs (1) | 743 | 215 | 927 | 215 | ||||||||||||
| Non-GAAP adjusted earnings | $ | 19,781 | $ | 20,220 | $ | 27,644 | $ | 12,228 | ||||||||
| Add interest expense of convertible debt, net of tax (2) | 1,958 | 2,156 | 3,774 | - | ||||||||||||
| Numerator | $ | 21,739 | $ | 22,376 | $ | 31,418 | $ | 12,228 | ||||||||
| Shares used in calculation (2) | 81,356 | 81,186 | 81,044 | 62,955 | ||||||||||||
| Non-GAAP adjusted earnings per share (2) | $ | 0.27 | $ | 0.28 | $ | 0.39 | $ | 0.19 | ||||||||
| (1) Other costs represents non-recurring costs associated with the special meeting requests of an activist investor and costs associated with the Company's defense of Horizon Pharma's hostile takeover attempt | ||||||||||||||||
| (2) The Company uses the if-converted method to compute diluted earnings per share with respect to its convertible debt. There was no add-back of interest expense or additional dilutive shares related to the convertible debt for the six months ending June 30, 2015 as the effect is anti-dilutive | ||||||||||||||||
| RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA | ||||||||||||||||
| (in thousands) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| GAAP net loss | $ | (10,541 | ) | $ | (21,653 | ) | $ | (31,458 | ) | $ | (33,286 | ) | ||||
| Intangible amortization related to product acquisitions | 27,037 | 26,731 | 54,074 | 29,271 | ||||||||||||
| Inventory step-up related to product acquisitions | 5 | 5,057 | 16 | 5,202 | ||||||||||||
| Product sales benefit related to product acquisitions | - | 10,466 | - | 10,466 | ||||||||||||
| Contingent consideration related to product acquisitions | 490 | (797 | ) | 907 | (1,895 | ) | ||||||||||
| Stock based compensation | 4,328 | 3,253 | 8,238 | 6,066 | ||||||||||||
| Interest and other income | (67 | ) | (61 | ) | (197 | ) | (118 | ) | ||||||||
| Interest expense | 25,320 | 21,433 | 47,336 | 27,010 | ||||||||||||
| Depreciation | 632 | 627 | 1,262 | 1,048 | ||||||||||||
| Benefit from income taxes | (5,656 | ) | (17,578 | ) | (11,650 | ) | (21,758 | ) | ||||||||
| Other costs (1) | 743 | 215 | 927 | 215 | ||||||||||||
| Transaction costs | 1 | 9,685 | 44 | 12,117 | ||||||||||||
| Non-GAAP adjusted EBITDA | $ | 42,292 | $ | 37,378 | $ | 69,499 | $ | 34,338 | ||||||||
| (1) Other costs represents non-recurring costs associated with the special meeting requests of an activist investor and costs associated with the Company's defense of Horizon Pharma's hostile takeover attempt | ||||||||||||||||
| RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | ||||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||
| (unaudited) | ||||||||||||||||||||||||
| Three Months Ended | Three Months Ended | |||||||||||||||||||||||
| June 30, 2016 | June 30, 2015 | |||||||||||||||||||||||
| GAAP | Non-GAAP | GAAP | Non-GAAP | |||||||||||||||||||||
| Reported | Adjustments | Adjusted | Reported | Adjustments | Adjusted | |||||||||||||||||||
| Total revenues | 116,682 | - | 116,682 | 94,504 | 10,466 | (a) | 104,970 | |||||||||||||||||
| Cost of sales | 20,965 | (13 | ) | (b) | 20,952 | 22,865 | (5,061 | ) | (b) | 17,804 | ||||||||||||||
| Research and development expense | 7,116 | (131 | ) | (c) | 6,985 | 4,714 | (46 | ) | (c) | 4,668 | ||||||||||||||
| Selling, general and administrative expense | 51,903 | (4,822 | ) | (d) | 47,081 | 57,408 | (1,976 | ) | (d) | 55,432 | ||||||||||||||
| Amortization of intangible assets | 27,037 | (27,037 | ) | (e) | - | 26,731 | (26,731 | ) | (e) | - | ||||||||||||||
| Loss on prepayment of Senior Notes | 5,777 | (777 | ) | (f) | 5,000 | - | - | - | ||||||||||||||||
| Interest expense | (20,148 | ) | (4,989 | ) | (g) | (15,159 | ) | (22,078 | ) | (4,629 | ) | (g) | (17,449 | ) | ||||||||||
| Benefit from (provision for) income taxes | 5,656 | (7,447 | ) | (h) | (1,791 | ) | 17,578 | (7,036 | ) | (h) | 10,542 | |||||||||||||
| Net (loss)/adjusted earnings | (10,541 | ) | 30,322 | (i) | 19,781 | (21,653 | ) | 41,873 | (i) | 20,220 | ||||||||||||||
| Explanation of adjustments: | ||||||||||||||||||||||||
| (a) Product sales benefit related to product acquisition | ||||||||||||||||||||||||
| (b) Inventory step-up related to product acquisitions and stock based compensation | ||||||||||||||||||||||||
| (c) Stock-based compensation | ||||||||||||||||||||||||
| (d) Non-recurring costs (Horizon Pharma and activist investor costs) of $743 and $215, stock-based compensation of $4,189 and $3,203, contingent | ||||||||||||||||||||||||
| consideration of ($110) and ($1,442) for the three months ended in June 30, 2016 and 2015, respectively | ||||||||||||||||||||||||
| (e) Amortization of intangible assets | ||||||||||||||||||||||||
| (f) Non-cash acceleration of debt discount | ||||||||||||||||||||||||
| (g) Non-cash interest expense of $4,389 and $3,984, contingent consideration of $600 and $645 for the three months ended in June 30, 2016 | ||||||||||||||||||||||||
| and 2015, respectively | ||||||||||||||||||||||||
| (h) Non-cash taxes | ||||||||||||||||||||||||
| (i) Calculated by taking (a) plus (h) minus sum of (b) through (g) | ||||||||||||||||||||||||
| Six Months Ended | Six Months Ended | |||||||||||||||||||||||
| June 30, 2016 | June 30, 2015 | |||||||||||||||||||||||
| GAAP | Non-GAAP | GAAP | Non-GAAP | |||||||||||||||||||||
| Reported | Adjustments | Adjusted | Reported | Adjustments | Adjusted | |||||||||||||||||||
| Total revenues | 221,462 | - | 221,462 | 126,708 | 10,466 | (a) | 137,174 | |||||||||||||||||
| Cost of sales | 44,514 | (32 | ) | (b) | 44,482 | 25,977 | (5,207 | ) | (b) | 20,770 | ||||||||||||||
| Research and development expense | 13,065 | (208 | ) | (c) | 12,857 | 6,572 | (183 | ) | (c) | 6,389 | ||||||||||||||
| Selling, general and administrative expense | 104,462 | (8,654 | ) | (d) | 95,808 | 91,950 | (3,108 | ) | (d) | 88,842 | ||||||||||||||
| Amortization of intangible assets | 54,074 | (54,074 | ) | (e) | - | 29,271 | (29,271 | ) | (e) | - | ||||||||||||||
| Loss on prepayment of Senior Notes | 5,777 | (777 | ) | (f) | 5,000 | - | - | - | ||||||||||||||||
| Interest expense | (42,875 | ) | (9,818 | ) | (g) | (52,693 | ) | (28,100 | ) | (8,495 | ) | (g) | (36,595 | ) | ||||||||||
| Benefit from (provision for) income taxes | 11,650 | (14,461 | ) | (h) | (2,811 | ) | 21,758 | (11,216 | ) | (h) | 10,542 | |||||||||||||
| Net (loss)/adjusted earnings | (31,458 | ) | 59,102 | (i) | 27,644 | (33,286 | ) | 45,514 | (i) | 12,228 | ||||||||||||||
| Explanation of adjustments | ||||||||||||||||||||||||
| (a) Product sales benefit related to product acquisition | ||||||||||||||||||||||||
| (b) Inventory step-up related to product acquisitions and stock based compensation | ||||||||||||||||||||||||
| (c) Stock-based compensation | ||||||||||||||||||||||||
| (d) Non-recurring costs (Horizon Pharma and activist investor costs) of $927 and $215, stock-based compensation of $8,014 and $5,878, contingent | ||||||||||||||||||||||||
| consideration of ($287) and $(2,985) for the three months ended in June 30, 2016 and 2015, respectively | ||||||||||||||||||||||||
| (e) Amortization of intangible assets | ||||||||||||||||||||||||
| (f) Non-cash acceleration of debt discount | ||||||||||||||||||||||||
| (g) Non-cash interest expense of $8,624 and $7,405, contingent consideration of $1,194 and $1,090 for the three months ended in June 30, 2016 | ||||||||||||||||||||||||
| and 2015, respectively | ||||||||||||||||||||||||
| (h) Non-cash taxes | ||||||||||||||||||||||||
| (i) Calculated by taking (a) plus (h) minus sum of (b) through (g) | ||||||||||||||||||||||||
INVESTOR CONTACT: Christopher Keenan VP, Investor Relations and Corporate Communications Depomed, Inc. 510-744-8000 ckeenan@depomed.com
