Full Press Release Details
SAN FRANCISCO , Feb. 26, 2014 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR ) today reported its financial results for the fourth quarter and year ended December 31, 2013 .
Cash and investments in marketable securities at December 31, 2013 were $262.0 million as compared to $302.2 million at December 31, 2012 . The 2013 year-end cash balance does not include net proceeds of $117.2 million received from the completion of a public equity offering in January 2014 .
"2014 has the potential to be a transformative year for Nektar as several of our highly valuable late-stage programs advance toward approval or filing," said Howard W. Robin , President and Chief Executive Officer of Nektar. "For naloxegol, our partner AstraZeneca has filed for regulatory approvals in the U.S., Europe and Canada . Naloxegol could be the first once-daily oral therapy approved to treat opioid-induced constipation. The Phase 3 study for BAX 855, a longer-acting PEGylated Factor VIII therapy, has completed enrollment and our partner Baxter intends to file the BLA by the end of 2014. Finally, the NKTR-102 BEACON Phase 3 study in advanced breast cancer successfully passed its interim efficacy analysis. Topline data from this pivotal study is expected by early 2015 and we intend to file NKTR-102 in both the U.S. and Europe in 2015."
Revenue for the fourth quarter of 2013 was $31.1 million as compared to $21.1 million in the fourth quarter of 2012. Revenue for the year ended December 31, 2013 was $148.9 million as compared to $81.2 million in 2012. Revenues included non-cash royalty revenue, related to our 2012 royalty monetization, of $9.3 million and $22.1 million in the fourth quarter and the full year of 2013, respectively, and $3.9 million and $10.8 million in the fourth quarter and the full year of 2012. This non-cash royalty revenue is offset by non-cash interest expense. The increase in revenue in the fourth quarter of 2013 as compared to the fourth quarter of 2012 is primarily due to increased product shipments to one of our collaboration partners. In addition, the increase in revenue in 2013 as compared to 2012 is primarily due to a $25.0 million milestone achieved in September 2013 upon the acceptance of the naloxegol MAA filing in Europe as well as a $10.0 million milestone achieved upon the initiation of Phase 3 studies for Amikacin Inhale in April 2013 .
Total operating costs and expenses in the fourth quarter of 2013 were $67.0 million as compared to $64.5 million in the fourth quarter of 2012. Total operating costs and expenses for the year ended December 31, 2013 were $269.1 million as compared to $222.4 million in 2012. The increase in 2013 as compared to 2012 is due primarily to increased clinical development expenses.
Research and development expense in the fourth quarter of 2013 was $48.2 million as compared to $46.4 million for the fourth quarter of 2012. For the year ended December 31, 2013 , R&D expense was $190.0 million as compared to $148.7 million in 2012. R&D expense was higher in the year ended December 31, 2013 as compared to 2012 reflecting the costs of the Phase 3 study of etirinotecan pegol (NKTR-102) in metastatic breast cancer, the Phase 2 study of NKTR-181, preparation for the Phase 3 study of NKTR-181, the Phase 1 study of NKTR-192, and the production of devices for the Phase 3 study of Amikacin Inhale.
General and administrative expense was $9.8 million in the fourth quarter of 2013 as compared to $10.9 million in the fourth quarter of 2012. G&A expense for the year ended December 31, 2013 was $40.5 million as compared to $41.6 million in 2012.
Non-cash interest expense incurred in connection with the 2012 royalty monetization was $5.7 million and $22.3 million in the fourth quarter and year ended December 31, 2013 , respectively, as compared to $5.4 million and $18.1 million in the fourth quarter and year ended December 31, 2012 , respectively.
Net loss for the fourth quarter ended December 31, 2013 was $47.7 million or $0.41 loss per share. Net loss for the year ended December 31, 2013 was $162.0 million or $1.40 loss per share. Net loss for the fourth quarter ended December 31, 2012 was $52.9 million or $0.46 loss per share. Net loss for the year ended December 31, 2012 was $171.9 million or $1.50 loss per share.
Conference Call to Discuss Fourth Quarter and Year-End 2013 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time today, Wednesday, February 26, 2014 .
This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investor Relations section of the Nektar website: http://www.nektar.com . The web broadcast of the conference call will be available for replay through Monday, March 31, 2014 .
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international) Passcode : 72309374 (Nektar Therapeutics is the host)
In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.
Nektar Therapeutics (NASDAQ: NKTR ) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which has been filed for regulatory approvals in the U.S., Europe and Canada as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-171, a new sodium channel blocker being developed as an oral therapy for the treatment of peripheral neuropathic pain, is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian, colorectal, lung and brain cancers. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development for patients with hemophilia A.
Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia ® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS ® for hepatitis C and Amgen's Neulasta ® for neutropenia.
Nektar is headquartered in San Francisco, California , with additional operations in Huntsville, Alabama and Hyderabad, India . Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com .
| Nektar Investor Inquiries: | ||
| Jennifer Ruddock/Nektar Therapeutics | (415) 482-5585 | |
| Susan Noonan/SA Noonan Communications, LLC | (212) 966-3650 | |
| Nektar Media Inquiries: | ||
| Brianne Cannon/MSL | (415) 512-0770 |
| NEKTAR THERAPEUTICS | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (In thousands) | |||||||
| (Unaudited) | |||||||
| ASSETS | December 31, 2013 | December 31, 2012 | (1) | ||||
| Current assets: | |||||||
| Cash and cash equivalents | $ 39,067 | $ 25,437 | |||||
| Short-term investments | 197,959 | 251,757 | |||||
| Accounts receivable, net | 2,229 | 5,805 | |||||
| Inventory | 13,452 | 18,269 | |||||
| Other current assets | 5,175 | 13,363 | |||||
| Total current assets | 257,882 | 314,631 | |||||
| Restricted cash | 25,000 | 25,000 | |||||
| Property and equipment, net | 66,974 | 72,215 | |||||
| Goodwill | 76,501 | 76,501 | |||||
| Other assets | 8,170 | 9,443 | |||||
| Total assets | $ 434,527 | $ 497,790 | |||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ 9,115 | $ 2,863 | |||||
| Accrued compensation | 14,254 | 8,773 | |||||
| Accrued expenses | 6,243 | 8,008 | |||||
| Accrued clinical trial expenses | 16,905 | 17,500 | |||||
| Deferred revenue, current portion | 23,664 | 21,896 | |||||
| Interest payable | 6,917 | 7,083 | |||||
| Liability related to sale of future royalties, current portion | 7,000 | 3,000 | |||||
| Other current liabilities | 14,123 | 9,414 | |||||
| Total current liabilities | 98,221 | 78,537 | |||||
| Senior secured notes | 125,000 | 125,000 | |||||
| Capital lease obligations, less current portion | 8,049 | 11,607 | |||||
| Liability related to receipt of refundable milestone payment | 70,000 | - | |||||
| Liability related to sale of future royalties, less current portion | 121,520 | 128,266 | |||||
| Deferred revenue, less current portion | 82,384 | 96,551 | |||||
| Other long-term liabilities | 19,256 | 10,811 | |||||
| Total liabilities | 524,430 | 450,772 | |||||
| Commitments and contingencies | |||||||
| Stockholders' equity (deficit) : | |||||||
| Preferred stock | - | - | |||||
| Common stock | 11 | 11 | |||||
| Capital in excess of par value | 1,643,660 | 1,617,744 | |||||
| Accumulated other comprehensive loss | (1,181) | (357) | |||||
| Accumulated deficit | (1,732,393) | (1,570,380) | |||||
| Total stockholders' equity (deficit) | (89,903) | 47,018 | |||||
| Total liabilities and stockholders' equity (deficit) | $ 434,527 | $ 497,790 | |||||
| (1) The consolidated balance sheet at December 31, 2012 has been derived from the audited financial statements at that date but does not include all of the information and notes required by generally accepted accounting principles in the United States for complete financial statements. |
| NEKTAR THERAPEUTICS | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (In thousands, except per share information) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | Twelve Months Ended | |||||||
| December 31, | December 31, | |||||||
| 2013 | 2012 | 2013 | 2012 | |||||
| Revenue: | ||||||||
| Product sales | $ 8,040 | $ 10,405 | $ 44,846 | $ 35,399 | ||||
| Royalty revenue | 118 | 908 | 1,148 | 4,874 | ||||
| Non-cash royalty revenue related to sale of future royalties | 9,311 | 3,896 | 22,055 | 10,791 | ||||
| License, collaboration and other revenue | 13,677 | 5,937 | 80,872 | 30,127 | ||||
| Total revenue | 31,146 | 21,146 | 148,921 | 81,191 | ||||
| Operating costs and expenses: | ||||||||
| Cost of goods sold | 8,960 | 7,290 | 38,509 | 30,428 | ||||
| Research and development | 48,248 | 46,373 | 190,010 | 148,675 | ||||
| General and administrative | 9,832 | 10,864 | 40,532 | 41,614 | ||||
| Impairment of long-lived assets | - | - | - | 1,675 | ||||
| Total operating costs and expenses | 67,040 | 64,527 | 269,051 | 222,392 | ||||
| Loss from operations | (35,894) | (43,381) | (120,130) | (141,201) | ||||
| Non-operating income (expense): | ||||||||
| Interest income | 93 | 450 | 732 | 2,315 | ||||
| Interest expense | (4,565) | (4,682) | (18,453) | (15,489) | ||||
| Non-cash interest expense on liability related to sale of future royalties | (5,665) | (5,416) | (22,309) | (18,057) | ||||
| Other income (expense), net | 7 | 70 | 392 | 983 | ||||
| Total non-operating expense, net | (10,130) | (9,578) | (39,638) | (30,248) | ||||
| Loss before provision for income taxes | (46,024) | (52,959) | (159,768) | (171,449) | ||||
| Provision (benefit) for income taxes | 1,635 | (33) | 2,245 | 406 | ||||
| Net loss | $ (47,659) | $ (52,926) | $ (162,013) | $ (171,855) | ||||
| Basic and diluted net loss per share | $ (0.41) | $ (0.46) | $ (1.40) | $ (1.50) | ||||
| Weighted average shares outstanding used in computing basic and diluted net loss per share | 116,259 | 115,179 | 115,732 | 114,820 |
| NEKTAR THERAPEUTICS | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||
| (In thousands) | |||||||||
| (Unaudited) | |||||||||
| Twelve Months Ended December 31, | |||||||||
| 2013 | 2012 | ||||||||
| Cash flows from operating activities: | |||||||||
| Net loss | $ (162,013) | $ (171,855) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
| Non-cash royalty revenue related to sale of future royalties | (22,055) | (10,791) | |||||||
| Non-cash interest expense on liability related to sale of future royalties | 22,309 | 18,057 | |||||||
| Stock-based compensation | 17,708 | 16,199 | |||||||
| Depreciation and amortization | 14,275 | 14,508 | |||||||
| Impairment of long-lived assets | - | 1,675 | |||||||
| Other non-cash transactions | 664 | 845 | |||||||
| Changes in operating assets and liabilities: | |||||||||
| Accounts receivable, net | 3,576 | (867) | |||||||
| Inventory | 4,817 | (5,613) | |||||||
| Other assets | 6,423 | 6,031 | |||||||
| Accounts payable | 6,199 | (122) | |||||||
| Accrued compensation | 5,481 | (4,034) | |||||||
| Accrued expenses | (1,915) | 1,495 | |||||||
| Accrued clinical trial expenses | (595) | 5,547 | |||||||
| Deferred revenue | (12,399) | (9,384) | |||||||
| Interest payable | (166) | 5,278 | |||||||
| Liability related to receipt of refundable milestone payment | 70,000 | - | |||||||
| Other liabilities | 9,164 | 3,275 | |||||||
| Net cash used in operating activities | (38,527) | (129,756) | |||||||
| Cash flows from investing activities: | |||||||||
| Maturities of investments | 319,181 | 307,887 | |||||||
| Purchases of investments | (268,068) | (164,662) | |||||||
| Sales of investments | 2,887 | 5,378 | |||||||
| Restricted cash | - | (25,000) | |||||||
| Purchases of property and equipment | (4,091) | (10,583) | |||||||
| Net cash provided by investing activities | 49,909 | 113,020 | |||||||
| Cash flows from financing activities: | |||||||||
| Payment of capital lease obligations | (2,992) | (2,437) | |||||||
| (Repayment of) proceeds from sale of future royalties, net of $4.4 million of transaction costs in 2012 | (3,000) | 119,588 | |||||||
| Proceeds from issuance of senior secured notes, net of $4.5 million of issuance costs | - | 77,940 | |||||||
| Repayment of convertible subordinated notes | - | (172,407) | |||||||
| Proceeds from shares issued under equity compensation plans | 8,208 | 4,117 | |||||||
| Net cash provided by financing activities | 2,216 | 26,801 | |||||||
| Effect of exchange rates on cash and cash equivalents | 32 | 60 | |||||||
| Net increase in cash and cash equivalents | 13,630 | 10,125 | |||||||
| Cash and cash equivalents at beginning of period | 25,437 | 15,312 | |||||||
| Cash and cash equivalents at end of period | $ 39,067 | $ 25,437 | |||||||
| Supplemental disclosure of cash flow information: | |||||||||
| Cash paid for interest | $ 17,590 | $ 9,620 | |||||||
| Cash paid for income taxes | $ 1,014 | $ 1,021 | |||||||
| Retirement of convertible subordinated notes in exchange for senior secured notes | $ - | $ 42,548 |
SOURCE Nektar Therapeutics