Tuesday, May 21, 2013 Last update: 3:08 AM
Company Tech News as it Breaks
Nektar Therapeutics Reports Fourth Quarter and Year-End 2012 Financial Results
Submitted by admin on 2/28/2013 @ 1:15 PM
Companies mentioned in this article:
Nektar Therapeutics
SAN FRANCISCO, Feb. 28, 2013 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2012.
Cash, cash equivalents, and investments at December 31, 2012 were $302.2 million as compared to $414.9 million at December 31, 2011.
"As we enter 2013, Nektar is in an excellent position with five highly valuable late-stage programs across multiple therapeutic areas," said Howard W. Robin, President and Chief Executive Officer of Nektar. "With positive efficacy and safety results from the full Phase 3 KODIAC program for naloxegol, our partner AstraZeneca is preparing to submit registration filings in the U.S. and EU in the third quarter of this year. We are tremendously pleased that Bayer is scheduled to start the Phase 3 program next month for Amikacin Inhale in gram-negative pneumonia. Additionally, we expect to report key Phase 2 clinical data this summer for NKTR-181, our novel opioid analgesic, which represents a potential breakthrough for the treatment of chronic pain."
Revenue for the fourth quarter of 2012 was $21.1 million as compared to $15.8 million in the fourth quarter of 2011. Revenue for the year ended December 31, 2012 was $81.2 million as compared to $71.5 million in 2011. 2012 revenue included $10.8 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. For both the quarter and the year ended December 31, 2012, product sales increased significantly. These increases were partially offset by decreases in royalty revenues.
Total operating costs and expenses in the fourth quarter of 2012 were $64.5 million as compared to $50.3 million in the fourth quarter of 2011. Total operating costs and expenses for the year ended December 31, 2012 were $222.4 million as compared to $195.4 million in 2011. The increases in 2012 as compared to 2011 are due primarily to increased clinical development expenses as well as higher cost of goods related to increased product sales.
Research and development expense in the fourth quarter of 2012 was $46.4 million as compared to $33.3 million for the fourth quarter of 2011. For the year ended December 31, 2012, R&D expense was $148.7 million as compared to $126.8 million in 2011. R&D expense was higher in the fourth quarter and year ended December 31, 2012 as compared to the same periods in 2011 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, the Phase 1 and Phase 2 studies for NKTR-181, and the Phase 1 study for NKTR-192.
General and administrative expense was $10.9 million in the fourth quarter of 2012 as compared to $11.5 million in the fourth quarter of 2011. G&A expense for the year ended December 31, 2012 was $41.6 million as compared to $46.8 million in 2011.
Non-cash interest expense was $5.4 million and $18.1 million in the fourth quarter and year ended December 31, 2012, respectively. The company incurred non-cash interest expense as a result of the sale of future royalties related to Cimzia® and Mircera®. No non-cash interest expense was incurred in 2011.
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. Net loss for the fourth quarter ended December 31, 2011 was $37.5 million or $0.33 loss per share. Net loss for the year ended December 31, 2011 was $134.0 million or $1.19 loss per share.
The company also announced upcoming presentations at the following medical meetings and scientific congresses during the first half of 2013:
33(rd) International Symposium on Intensive Care and Emergency Medicine, Brussels, Belgium:
-- Poster P081: "In Vitro Efficiency of the Amikacin Inhale System, A Novel
Integrated Drug-Device Delivery System", Kadrichu, N., et al.
-- Date: March 19, 2013
American Association for Cancer Research 2013 Annual Meeting, Washington, DC:
-- Abstract #482: "Tipping the Balance in the Tumor Microenvironment: An
Engineered Cytokine (NKTR-214) with Altered IL-2 Receptor Binding
Selectivity and Improved Efficacy in a Mouse Melanoma Model", Charych,
D., et al.
-- Date: April 7, 2013, 1:00 p.m. -- 5:00 p.m. Eastern Time
-- Poster Session: Immunology 2
-- Abstract #2475: "A new polymer conjugated taxane shows improved efficacy
in tumor xenograft models", Fry, D., et al.
-- Date: April 9, 2013, 8:00 a.m. -- 12:00 p.m. Eastern Time
-- Poster Session: Chemistry 4
American Academy of Pain Medicine 29(th) Annual Meeting, Fort Lauderdale, FL:
-- Poster #115 : "New Oral Opioid Analgesic NKTR-181 Demonstrates Analgesic
Response in Cold Pressor Test in Healthy Subjects", Eldon, M., et al.
-- Date: April 11, 2013, 5:15 p.m. -- April 12, 2013 10:30 a.m. Eastern
Time
American Pain Society 32(nd) Annual Scientific Meeting, New Orleans, LA:
-- Poster: "NKTR-171: A Novel, Oral Sodium Channel Blocker That Exhibits
Comparable Analgesic Efficacy to Pregabalin with Reduced Central Nervous
System (CNS) Side Effects", Gursahani, H., et al.
-- Date: May 9, 2013, 9:30 a.m. Eastern Time
Digestive Disease Week 2013, Orlando, FL:
-- Abstract 1594557: "Efficacy and Safety of Naloxegol in Patients with
Opioid-Induced Constipation: Results from 2 Prospective, Randomized,
Controlled Trials", Chey, W., et al.
-- Date: May 21, 2013, 8:15 a.m. Eastern Time
-- Research Forum: New Pharmacological Treatments for Motility
Disorders
4(th) International Congress on Neuropathic Pain, Toronto, Canada:
-- Poster A-484-0002-00647: "NKTR-171: Preclinical Efficacy and Improved
Central Nervous System (CNS) Side Effect Profile of a Novel Sodium
Channel Blocker Designed for the Treatment of Neuropathic Pain",
Gursahani, H., et al.
-- Date: May 25, 2013, 1:30 p.m. - 3:30 p.m. Eastern Time
-- Poster Session II
College on Problems of Drug Dependence 75(th) Annual Meeting, San Diego, CA:
-- Poster 1598130: "Opioids With Lower Brain Uptake Are Less Recognizable
in Rat Drug Discrimination Tests and thus Potentially Less Subject to
Abuse", Harrison, S., et al.
-- Date: June 19, 2013, 12:00 p.m. - 2:00 p.m. Pacific Time
-- Poster 1605508: "Abuse Potential Assessment of Novel Opioid Analgesic
NKTR-181: Implications for Labeling", Webster, L., et al.
-- Date: June 20, 2013, 7:30 a.m. - 9:30 a.m. Pacific Time
Conference Call to Discuss Fourth Quarter and Year-End 2012 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, February 28, 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 Friday, March 15, 2013.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 98224860 (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.
About Nektar
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 is being evaluated in Phase 3 clinical studies 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.
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
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential future regulatory filings by AstraZeneca for naloxegol; the projected timing of the start of the Phase 3 clinical study by Bayer for Amikacin Inhale; the projected availability of Phase 2 clinical study results for NKTR-181; and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, (i) our drug candidates and those of our collaboration partners are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval for numerous reasons including safety and efficacy findings even after positive findings in previous preclinical and clinical studies; (ii) the timing of the commencement or end of clinical trials and the commercial launch of our drug candidates may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iii) acceptance, review and approval decisions for new drug applications by health authorities is an uncertain and evolving process and health authorities retain significant discretion at all stages of the regulatory review and approval decision process; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of our technology platform to potential new drug candidates is therefore highly uncertain and unpredictable and one or more research and development programs could fail; and (v) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2012. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Nektar Investor Inquiries:
Jennifer Ruddock/Nektar Therapeutics (415) 482-5585
Susan Noonan/SA Noonan Communications,
LLC (212) 966-3650
Nektar Media Inquiries:
Amanda Connelly/MSL (404) 870-6865
Mike Huckman /MSL (646) 500-7631
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
ASSETS December 31, 2012 December 31, 2011 (1)
----------------- -----------------
Current assets:
Cash and cash
equivalents $25,437 $15,312
Short-term
investments 251,757 225,856
Accounts
receivable, net 5,805 4,938
Inventory 18,269 12,656
Other current
assets 13,363 17,944
--------------
Total current assets 314,631 276,706
Long-term investments - 173,768
Restricted cash 25,000 -
Property and equipment, net 72,215 78,576
Goodwill 76,501 76,501
Other assets 9,443 999
----- ---
Total assets $497,790 $606,550
============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $2,863 $3,019
Accrued
compensation 8,773 12,807
Accrued expenses 8,008 6,669
Accrued clinical
trial expenses 17,500 11,953
Deferred revenue,
current portion 21,896 19,643
Interest payable 7,083 1,805
Convertible
subordinated
notes - 214,955
Other current
liabilities 12,414 4,681
--------------
Total current liabilities 78,537 275,532
Senior secured notes 125,000 -
Capital lease obligations, less current portion 11,607 14,582
Liability related to sale of future royalties, less
current portion 128,266 -
Deferred revenue, less current portion 96,551 108,188
Deferred gain 2,404 3,278
Other long-term liabilities 8,407 7,159
----- -----
Total liabilities 450,772 408,739
Commitments and contingencies
Stockholders' equity:
Preferred stock - -
Common stock 11 11
Capital in excess
of par value 1,617,744 1,597,428
Accumulated other
comprehensive
loss (357) (1,103)
Accumulated
deficit (1,570,380) (1,398,525)
-----------
Total stockholders' equity 47,018 197,811
Total liabilities
and
stockholders'
equity $497,790 $606,550
==================
(1) The consolidated balance sheet at December
31, 2011 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,
------------ ------------
2012 2011 2012 2011
---- ---- ---- ----
Revenue:
Product sales $10,405 $6,073 $35,399 $24,864
Royalty revenues 908 3,095 4,874 10,327
Non-cash royalty
revenue related to
sale of future
royalties 3,896 - 10,791 -
License,
collaboration and
other 5,937 6,614 30,127 36,289
----- ----- ------ ------
Total revenue 21,146 15,782 81,191 71,480
Operating costs and
expenses:
Cost of goods sold 7,290 5,450 30,428 21,891
Research and
development 46,373 33,302 148,675 126,766
General and
administrative 10,864 11,498 41,614 46,760
Impairment of long-
lived assets - - 1,675 -
Total operating
costs and expenses 64,527 50,250 222,392 195,417
------ ------ ------- -------
Loss from
operations (43,381) (34,468) (141,201) (123,937)
Non-operating
income (expense):
Interest income 450 661 2,315 2,244
Interest expense (4,682) (2,525) (15,489) (10,223)
Non-cash interest
expense on
liability related
to sale of future
royalties (5,416) - (18,057) -
Other income
(expense), net 70 (445) 983 (1,044)
--- ---- --- ------
Total non-
operating expense,
net (9,578) (2,309) (30,248) (9,023)
Loss before
provision for
income taxes (52,959) (36,777) (171,449) (132,960)
Provision (benefit)
for income taxes (33) 718 406 1,018
--- --- --- -----
Net loss $(52,926) $(37,495) $(171,855) $(133,978)
======== ======== ========= =========
Basic and diluted
net loss per share $(0.46) $(0.33) $(1.50) $(1.19)
Weighted average
shares outstanding
used in computing
basic and diluted
net loss per share
115,179 114,446 114,820 112,942
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Twelve Months Ended December 31,
--------------------------------
2012 2011
---- ----
Cash flows from operating activities:
Net loss $(171,855) $(133,978)
Adjustments to reconcile net loss to net cash used in
operating activities:
Non-cash interest expense on liability related to
sale of future royalties 18,057 -
Non-cash royalty revenue related to sale of future
royalties (10,791) -
Stock-based compensation 16,199 18,885
Depreciation and amortization 14,508 14,951
Impairment of long-lived assets 1,675 -
Other non-cash transactions 845 1,359
Changes in operating assets and liabilities:
Accounts receivable (867) 20,164
Inventory (5,613) (5,390)
Other assets 6,031 (12,267)
Accounts payable (122) (3,384)
Accrued compensation (4,034) 3,555
Accrued expenses 1,495 1,013
Accrued clinical trial expenses 5,547 (191)
Deferred revenue (9,384) (17,516)
Interest payable 5,278 -
Other liabilities 3,275 (943)
Net cash used in operating activities (129,756) (113,742)
Cash flows from investing activities:
Purchases of property and equipment (10,583) (9,722)
Restricted cash (25,000) -
Maturities of investments 307,887 383,052
Sales of investments 5,378 210,089
Purchases of investments (164,662) (695,371)
-------- --------
Net cash provided by (used in) investing activities 113,020 (111,952)
Cash flows from financing activities:
Proceeds from issuance of senior secured notes, net 77,940 -
Repayment of convertible subordinated notes (172,407) -
Payment of capital lease obligations (2,437) (1,978)
Proceeds from sale of future royalties, net 119,588 -
Proceeds from shares issued under equity compensation
plans 4,117 4,530
Issuance of common stock, net - 219,783
Net cash provided by financing activities 26,801 222,335
------ -------
Effect of exchange rates on cash and cash equivalents 60 916
--- ---
Net increase (decrease) in cash and cash equivalents 10,125 (2,443)
Cash and cash equivalents at beginning of period 15,312 17,755
Cash and cash equivalents at end of period $25,437 $15,312
======= =======
Supplemental disclosure of cash flow information:
Cash paid for interest $9,620 $10,277
====== =======
Cash paid for income taxes $1,021 $957
====== ====
Supplemental schedule of non-cash investing and
financing activities:
Retirement of convertible subordinated notes in
exchange for senior secured notes $42,548 $ -
======= ==================
SOURCE Nektar Therapeutics