Full Press Release Details
SAN FRANCISCO , May 9, 2013 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR ) today reported its financial results for the first quarter ended March 31, 2013 .
Cash and investments in marketable securities at March 31, 2013 were $261.2 million as compared to $302.2 million at December 31, 2012 .
"We made great progress advancing two key clinical programs for Nektar over the past quarter," said Howard W. Robin , President and Chief Executive Officer of Nektar. "Our partner Bayer initiated Phase 3 studies for Amikacin Inhale in gram-negative pneumonia. Up to 90% of hospital pneumonias occur in patients who are on ventilators and Amikacin Inhale could provide physicians with a new treatment option for treating these deadly pneumonias. In addition, Nektar initiated our second Phase 2 study for NKTR-181, our wholly-owned analgesic molecule which has received Fast Track Status from the FDA. We expect to report data from both Phase 2 studies of NKTR-181 during the summer."
Revenue for the first quarter of 2013 was $23.0 million as compared to $17.9 million in the first quarter of 2012. Revenue for the first quarter of 2013 included $4.4 million in non-cash revenues resulting from the $124 million sale of future royalties related to Cimzia® and Mircera®, which was completed in February 2012 . This non-cash royalty revenue is offset by non-cash interest expense. In addition, product sales increased by $4.9 million in the first quarter of 2013 as compared to the first quarter of 2012. This increase was partially offset by decreases in royalty revenues and license, collaboration and other revenues.
Total operating costs and expenses for the first quarter of 2013 were $68.4 million as compared to $55.9 million in the first quarter of 2012. Total operating costs and expenses increased primarily as a result of increased clinical development expenses as well as higher cost of goods related to increased product sales.
Research and development expense in the first quarter of 2013 was $45.6 million as compared to $35.1 million for the first quarter of 2012. R&D expense was higher in the first quarter of 2013 reflecting the costs of the etirinotecan pegol (NKTR-102) BEACON Phase 3 study, the production of devices for the Phase 3 study of Amikacin Inhale, and Phase 2 studies for NKTR-181.
General and administrative expense was $11.1 million in the first quarter of 2013 as compared to $10.4 million in the first quarter of 2012.
Non-cash interest expense was $5.5 million in the first quarter of 2013 as compared to $1.8 million in the first quarter of 2012. The company incurred non-cash interest expense as a result of the sale of future royalties related to Cimzia® and Mircera®.
Net loss for the first quarter of 2013 was $55.1 million or $0.48 loss per share as compared to $41.1 million or $0.36 loss per share in the first quarter of 2012.
The company also announced upcoming presentations at the following medical meetings and scientific congresses during the first half of 2013:
American Pain Society 32 nd Annual Scientific Meeting, New Orleans, LA :
Digestive Disease Week 2013, Orlando, FL :
4 th International Congress on Neuropathic Pain, Toronto, Canada :
American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL :
The International Conference on Opioids, Boston, MA :
College on Problems of Drug Dependence 75 th Annual Meeting, San Diego, CA :
Conference Call to Discuss First Quarter 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, Thursday, May 9, 2013 .
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, June 10, 2013 .
| To access the conference call, follow these instructions: | |
| Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international) | |
| Passcode : 36590300 (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 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 completed Phase 3 development 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 candidate for chronic pain conditions, is in Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development to treat acute 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 and colorectal 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.
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. 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.
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 .
Cautionary Note Regarding Forward-Looking Statements
| Nektar Investor Inquiries: | |
| Jennifer Ruddock/Nektar Therapeutics | (415) 482-5585 |
| Susan Noonan/SA Noonan Communications, LLC | (212) 966-3650 |
| Nektar Media Inquiries: | |
| Karin Bauer/MSL | (415) 817-2549 |
| Mike Huckman /MSL | (646) 500-7631 |
| NEKTAR THERAPEUTICS | ||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (In thousands) | ||||||
| (Unaudited) | ||||||
| ASSETS | March 31, 2013 | December 31, 2012 | (1) | |||
| Current assets: | ||||||
| Cash and cash equivalents | $ 28,531 | $ 25,437 | ||||
| Short-term investments | 207,664 | 251,757 | ||||
| Accounts receivable | 3,647 | 5,805 | ||||
| Inventory | 18,381 | 18,269 | ||||
| Other current assets | 8,813 | 13,363 | ||||
| Total current assets | 267,036 | 314,631 | ||||
| Restricted cash | 25,000 | 25,000 | ||||
| Property and equipment, net | 70,112 | 72,215 | ||||
| Goodwill | 76,501 | 76,501 | ||||
| Other assets | 9,252 | 9,443 | ||||
| Total assets | $ 447,901 | $ 497,790 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ 4,218 | $ 2,863 | ||||
| Accrued compensation | 8,952 | 8,773 | ||||
| Accrued expenses | 6,946 | 8,008 | ||||
| Accrued clinical trial expenses | 24,032 | 17,500 | ||||
| Deferred revenue, current portion | 23,239 | 21,896 | ||||
| Interest payable | 3,167 | 7,083 | ||||
| Other current liabilities | 12,667 | 12,414 | ||||
| Total current liabilities | 83,221 | 78,537 | ||||
| Senior secured notes | 125,000 | 125,000 | ||||
| Capital lease obligations, less current portion | 10,766 | 11,607 | ||||
| Liability related to sale of future royalties, less current portion | 122,416 | 128,266 | ||||
| Deferred revenue, less current portion | 97,918 | 96,551 | ||||
| Deferred gain | 2,185 | 2,404 | ||||
| Other long-term liabilities | 9,015 | 8,407 | ||||
| Total liabilities | 450,521 | 450,772 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity: | ||||||
| Preferred stock | - | - | ||||
| Common stock | 11 | 11 | ||||
| Capital in excess of par value | 1,623,207 | 1,617,744 | ||||
| Accumulated other comprehensive loss | (395) | (357) | ||||
| Accumulated deficit | (1,625,443) | (1,570,380) | ||||
| Total stockholders' (deficit) equity | (2,620) | 47,018 | ||||
| Total liabilities and stockholders' equity | $ 447,901 | $ 497,790 |
| NEKTAR THERAPEUTICS | |||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||
| (In thousands, except per share information) | |||
| (Unaudited) | |||
| Three Months Ended March 31, | |||
| 2013 | 2012 | ||
| Revenue: | |||
| Product sales | $ 11,810 | $ 6,945 | |
| Royalty revenues | 325 | 3,177 | |
| Non-cash royalty revenue related to sale of future royalties | 4,393 | - | |
| License, collaboration, and other | 6,476 | 7,827 | |
| Total revenue | 23,004 | 17,949 | |
| Operating costs and expenses: | |||
| Cost of goods sold | 11,661 | 8,707 | |
| Research and development | 45,618 | 35,085 | |
| General and administrative | 11,129 | 10,414 | |
| Impairment of long-lived assets | - | 1,675 | |
| Total operating costs and expenses | 68,408 | 55,881 | |
| Loss from operations | (45,404) | (37,932) | |
| Non-operating income (expense): | |||
| Interest income | 314 | 632 | |
| Interest expense | (4,645) | (2,548) | |
| Non-cash interest expense on liability related to sale of future royalties | (5,543) | (1,785) | |
| Other income (expense), net | 427 | 660 | |
| Total non-operating expense, net | (9,447) | (3,041) | |
| Loss before provision for income taxes | (54,851) | (40,973) | |
| Provision for income taxes | 212 | 124 | |
| Net loss | $ (55,063) | $ (41,097) | |
| Basic and diluted net loss per share | $ (0.48) | $ (0.36) | |
| Weighted average shares used in computing basic and diluted net loss per share | 115,309 | 114,531 |
| NEKTAR THERAPEUTICS | |||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||
| (In thousands) | |||
| (Unaudited) | |||
| Three Months Ended March 31, | |||
| 2013 | 2012 | ||
| Cash flows from operating activities: | |||
| Net loss | $(55,063) | $ (41,097) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||
| Non-cash interest expense on liability related to sale of future royalties | 5,543 | 1,785 | |
| Non-cash royalty revenue related to sale of future royalties | (4,393) | - | |
| Stock-based compensation | 4,245 | 4,234 | |
| Depreciation and amortization | 3,628 | 3,510 | |
| Impairment of long-lived assets | - | 1,675 | |
| Other non-cash transactions | 139 | 295 | |
| Changes in operating assets and liabilities: | |||
| Accounts receivable | 2,158 | (5,865) | |
| Inventory | (112) | (1,452) | |
| Other assets | 3,844 | 4,305 | |
| Accounts payable | 1,355 | (1,290) | |
| Accrued compensation | 179 | (4,620) | |
| Accrued expenses | (1,130) | 1,094 | |
| Accrued clinical trial expenses | 6,532 | 773 | |
| Deferred revenue | 2,710 | 3,226 | |
| Interest payable | (3,916) | (1,747) | |
| Other liabilities | (3,830) | 556 | |
| Net cash used in operating activities | (38,111) | (34,618) | |
| Cash flows from investing activities: | |||
| Maturities of investments | 100,338 | 151,964 | |
| Purchases of investments | (56,336) | (102,023) | |
| Purchases of property and equipment | (316) | (1,516) | |
| Net cash provided by investing activities | 43,686 | 48,425 | |
| Cash flows from financing activities: | |||
| Payment of capital lease obligations | (692) | (566) | |
| (Repayment of) proceeds from sale of future royalties, net of transaction costs | (3,000) | 119,589 | |
| Proceeds from shares issued under equity compensation plans | 1,218 | 479 | |
| Net cash (used in) provided by financing activities | (2,474) | 119,502 | |
| Effect of exchange rates on cash and cash equivalents | (7) | (136) | |
| Net increase in cash and cash equivalents | 3,094 | 133,173 | |
| Cash and cash equivalents at beginning of period | 25,437 | 15,312 | |
| Cash and cash equivalents at end of period | $ 28,531 | $ 148,485 | |
| Supplemental disclosure of cash flow information: | |||
| Cash paid for interest | $ 8,250 | $ 4,199 |
SOURCE Nektar Therapeutics