UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): August 3, 2016
NEKTAR THERAPEUTICS
(Exact Name of Registrant as Specified in Charter)
| Delaware | 0-24006 | 94-3134940 | ||
|
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
455 Mission Bay Boulevard South
San Francisco, California 94158
(Address of Principal Executive Offices and Zip Code)
Registrant’s telephone number, including area code: (415) 482-5300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Item 2.02 Results of Operations and Financial Condition.
On August 3, 2016, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its financial results for the quarter ended June 30, 2016. A copy of the Press Release is furnished herewith as Exhibit 99.1.
On July 27, 2016, Nektar announced that it would hold a Webcast conference call on August 3, 2016 to review financial results for the quarter ended June 30, 2016. This conference call is accessible through a link that is posted on the home page and Investor Relations section of the Nektar website: http://www.nektar.com.
The information in this report, including the exhibit hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by Nektar Therapeutics, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release titled “Nektar Therapeutics Reports Financial Results for the Second Quarter of 2016” issued by Nektar Therapeutics on August 3, 2016. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEKTAR THERAPEUTICS | ||
| August 3, 2016 | By: | /s/ Gil M. Labrucherie |
| Gil M. Labrucherie | ||
| Senior Vice President and Chief Financial Officer |
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EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 |
Press Release titled “Nektar Therapeutics Reports Financial Results for the Second Quarter of 2016” issued by Nektar Therapeutics on August 3, 2016.
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Exhibit 99.1
Nektar Therapeutics Reports Financial Results for the Second Quarter of 2016
SAN FRANCISCO, Aug. 3, 2016 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the second quarter ended June 30, 2016.
Cash and investments in marketable securities at June 30, 2016 were $274.9 million as compared to $308.9 million at December 31, 2015. This balance includes the $28.0 million payment received from AstraZeneca in April of 2016 for the sublicense of MOVENTIG® (naloxegol) to ProStraken in Europe. The balance does not include the $20 million upfront payment for the licensing of European rights for ONZEALD™ to Daiichi Sankyo Europe, which occurred in Q2 2016.
"We continue to execute on the development and business objectives for Nektar," said Howard W. Robin, President and CEO of Nektar. "Following our licensing agreement with Daiichi Sankyo Europe, the MAA for ONZEALD was accepted by the EMA in July, and with an accelerated assessment review granted by the CHMP, we expect a decision on the recommendation for conditional approval in Q1 2017. Our Phase 3 study of NKTR-181 in patients with chronic low back pain has now completed enrollment and is on track to have topline data in the first quarter of 2017. Finally, NKTR-214 continues to advance in its Phase 1/2 study in cancer patients at MD Anderson and Yale Cancer Centers, with initial topline data expected before the end of this year. As the first medicine designed to selectively stimulate the in vivo growth of endogenous tumor-killing T cells and natural killer cells within the tumor micro-environment, we are extremely excited about the potential of NKTR-214 to transform the immuno-oncology landscape."
Year-to-date revenue for 2016 was $91.6 million as compared to $131.5 million in the first half of 2015. Revenue in 2016 included recognition of the $28.0 million cash payment received from AstraZeneca for the sublicense of MOVENTIG® (naloxegol) to ProStrakan (Kyowa Kirin) in Europe. In addition, product sales, royalty revenue, and non-cash royalty revenue increased in the first half of 2016 compared to the first half of 2015. Revenue in the first half of 2015 included recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S. in Q1 2015. Revenue in the second quarter of 2016 was $32.8 million as compared to $22.7 million in the second quarter of 2015.
Revenue included non-cash royalty revenue, related to our 2012 royalty monetization, of $8.1 million and $14.7 million in the second quarter and first half of 2016, respectively, and $4.7 million and $8.7 million in the second quarter and first half of 2015, respectively. This non-cash royalty revenue is offset by non-cash interest expense incurred in connection with the 2012 royalty monetization of $5.0 million and $10.0 million in the second quarter and first half of 2016, respectively and $5.2 million and $10.2 million in the second quarter and first half of 2015, respectively.
Total operating costs and expenses in the first half of 2016 were $139.5 million as compared to $131.9 million in the first half of 2015. Total operating costs and expenses in the second quarter of 2016 were $71.1 million as compared to $66.1 million in the second quarter of 2015. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.
Research and development expense in the second quarter of 2016 was $52.4 million as compared to $45.4 million in the second quarter of 2015. For the first half of 2016, R&D expense was $101.6 million as compared to $92.4 million in the first half of 2015. R&D expense was higher in the second quarter and first half of 2016 as compared to the same periods in 2015 primarily due to expenses for the NKTR-181 Phase 3 studies and the initiation of the Phase 1/2 study of NKTR-214.
General and administrative expense was $11.0 million in the second quarter of 2016 as compared to $10.2 million in the second quarter of 2015. G&A expense in the first half of 2016 was $21.3 million as compared to $20.5 million in the first half of 2015.
Net loss in the second quarter of 2016 was $48.6 million or $0.36 loss per share as compared to $52.7 million or $0.40 loss per share in the second quarter of 2015. Net loss in the first half of 2016 was $68.1 million or $0.50 loss per share as compared to $18.8 million or $0.14 loss per share in the first half of 2015.
The company also announced the following upcoming presentations and events:
Fourth Annual Immuno-Oncology Summit, Boston, MA:
· Oral Abstract: "Of Mice and Men: Translating the Immune Oncology Mechanism of Action of NKTR-214." Presented by: Jonathan Zavelsky, Ph.D.
o Date: August 31, 2016, 5:15 p.m. Eastern Time
Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference, New York, NY:
· Abstract/Poster #311: "The CD122-biased immunostimulatory cytokine NKTR-214 combined with checkpoint blockade leads to mobilization of antitumor immunity and synergistic activity", Langowski, J., et al.
o Date: September 26, 2016, 5:15 – 7:45 p.m. Eastern Time
ESMO 2016 Congress, Copenhagen, Denmark:
· Abstract #3048: "Combining Complementary Mechanisms of Immune Activation: NKTR-214, a Biased IL-2 Pathway Agonist, and Immune Checkpoint Antagonists", Charych, D., et al.
o Date: October 9, 2016, 1:00 – 2:00 p.m. Central European Time
10th Annual Pain and Migraine Therapeutics Conference, Chicago, IL:
· Oral Abstract: "Clinical Development of a Novel Opioid Molecule with Inherent Anti-abuse Properties", Presented by Carlo DiFonzo, Ph.D.
o Date: October 19, 2016, 1:00 – 1:30 p.m. Central Time
Conference Call to Discuss Second Quarter 2016 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, August 3, 2016.
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 Tuesday, September 6, 2016.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode:51021513 (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 has a robust R&D pipeline and portfolio of approved partnered medicines in oncology, pain, immunology and other therapeutic areas. In the area of oncology, Nektar is developing NKTR-214, an immuno-stimulatory CD122-biased agonist, that is in Phase 1/2 clinical development for patients with solid tumors. ONZEALD™ (etirinotecan pegol), a long-acting topoisomerase I inhibitor, is being developed for patients with advanced breast cancer and brain metastases and is partnered with Daiichi Sankyo in Europe. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for MOVANTIK™ (naloxegol), the first FDA-approved once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. The product is also approved in the European Union as MOVENTIG® (naloxegol) and is indicated for adult patients with OIC who have had an inadequate response to laxatives. The AstraZeneca agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of MOVANTIK and an opioid. NKTR-181, a wholly owned mu-opioid analgesic molecule for chronic pain conditions, is in Phase 3 development. In hemophilia, Nektar has a collaboration agreement with Baxalta for ADYNOVATE™ [Antihemophilic Factor (Recombinant)], a longer-acting PEGylated Factor VIII therapeutic approved in the U.S. and Japan for patients over 12 with hemophilia A. In anti-infectives, the company has two collaborations with Bayer Healthcare, Cipro Inhale in Phase 3 for non-cystic fibrosis bronchiectasis and Amikacin Inhale in Phase 3 for patients with Gram-negative pneumonia.
Nektar's technology has enabled nine approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including AstraZeneca's MOVANTIK™, Baxalta's ADYNOVATE™, 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.
MOVANTIK™ is a trademark and MOVENTIG® is a registered trademark of the AstraZeneca group of companies. ADYNOVATE™ is a trademark of Baxalta Inc.
ONZEALD™ is a trademark of Nektar Therapeutics.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which 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 timing of the
CHMP recommendation for ONZEALD, the timing of the availability of top-line data for the NKTR-181 Phase 3 clinical study, the
timing of availability of clinical data for the NKTR-214 Phase 1 study, the therapeutic potential of NKTR-214, and the potential
of our technology and drug candidates in our 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) the CHMP has substantial discretion as to whether to grant marketing approval for ONZEALD and
the European Medicines Agency's final decisions are difficult to predict and these decisions have significant financial consequences
under the terms of our agreement with Daiichi Sankyo Europe, including payment and milestone provisions; (ii) NKTR-214 is in early-stage
clinical development and there are substantial risks that can unexpectedly occur for numerous reasons including negative safety
and efficacy findings in the ongoing Phase 1 clinical study notwithstanding positive findings in preclinical studies; (iii) 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 negative safety and
efficacy findings even after positive findings in previous preclinical and clinical studies; (iv) the timing of the commencement
or end of clinical trials and the availability of clinical 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; (v) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future
success of applying our technology platform to potential new drug candidates (such as NKTR-181 and NKTR-214) is therefore highly
uncertain and unpredictable and one or more research and development programs could fail; (vi) patents may not issue from our
patent applications for our drug candidates including NKTR-181 and NKTR-214, patents that have issued may not be enforceable,
or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties
set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 4, 2016. 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.
Contact:
For Investors:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585
Jodi Sievers of Nektar Therapeutics
415-482-5593
For Media:
Dan Budwick of Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
| June 30, 2016 | December 31, 2015 | (1) | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 55,676 | $ | 55,570 | ||||
| Short-term investments | 219,178 | 253,374 | ||||||
| Accounts receivable, net | 27,777 | 19,947 | ||||||
| Inventory | 10,262 | 11,346 | ||||||
| Other current assets | 5,427 | 9,814 | ||||||
| Total current assets | 318,320 | 350,051 | ||||||
| Property, plant and equipment, net | 67,774 | 71,336 | ||||||
| Goodwill | 76,501 | 76,501 | ||||||
| Other assets | 504 | 754 | ||||||
| Total assets | $ | 463,099 | $ | 498,642 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,328 | $ | 2,363 | ||||
| Accrued compensation | 12,463 | 5,998 | ||||||
| Accrued clinical trial expenses | 13,470 | 8,220 | ||||||
| Other accrued expenses | 6,919 | 4,156 | ||||||
| Interest payable | 4,144 | 4,198 | ||||||
| Capital lease obligations, current portion | 3,616 | 4,756 | ||||||
| Liability related to refundable upfront payment | 12,500 | - | ||||||
| Deferred revenue, current portion | 16,015 | 21,428 | ||||||
| Other current liabilities | 7,827 | 10,127 | ||||||
| Total current liabilities | 79,282 | 61,246 | ||||||
| Senior secured notes, net | 242,567 | 241,699 | ||||||
| Capital lease obligations, less current portion | 2,756 | 1,073 | ||||||
| Liability related to the sale of future royalties, net | 111,590 | 116,029 | ||||||
| Deferred revenue, less current portion | 60,135 | 62,426 | ||||||
| Other long-term liabilities | 6,020 | 9,740 | ||||||
| Total liabilities | 502,350 | 492,213 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity (deficit): | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 13 | 13 | ||||||
| Capital in excess of par value | 1,898,342 | 1,876,072 | ||||||
| Accumulated other comprehensive loss | (2,019 | ) | (2,170 | ) | ||||
| Accumulated deficit | (1,935,587 | ) | (1,867,486 | ) | ||||
| Total stockholders' equity (deficit) | (39,251 | ) | 6,429 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 463,099 | $ | 498,642 | ||||
(1) The consolidated balance sheet at December 31, 2015 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales | $ | 12,867 | $ | 10,968 | $ | 26,966 | $ | 18,942 | ||||||||
| Royalty revenue | 3,516 | 745 | 7,576 | 870 | ||||||||||||
| Non-cash royalty revenue related to sale of future royalties | 8,115 | 4,740 | 14,650 | 8,702 | ||||||||||||
| License, collaboration and other revenue | 8,270 | 6,208 | 42,457 | 102,948 | ||||||||||||
| Total revenue | 32,768 | 22,661 | 91,649 | 131,462 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of goods sold | 7,708 | 10,534 | 16,578 | 18,978 | ||||||||||||
| Research and development | 52,350 | 45,412 | 101,618 | 92,423 | ||||||||||||
| General and administrative | 11,035 | 10,184 | 21,262 | 20,487 | ||||||||||||
| Total operating costs and expenses | 71,093 | 66,130 | 139,458 | 131,888 | ||||||||||||
| Loss from operations | (38,325 | ) | (43,469 | ) | (47,809 | ) | (426 | ) | ||||||||
| Non-operating income (expense): | ||||||||||||||||
| Interest expense | (5,627 | ) | (4,118 | ) | (11,304 | ) | (8,289 | ) | ||||||||
| Non-cash interest expense on liability related to sale of future royalties | (4,982 | ) | (5,152 | ) | (10,027 | ) | (10,202 | ) | ||||||||
| Interest income and other income (expense), net | 458 | 246 | 1,333 | 457 | ||||||||||||
| Total non-operating expense, net | (10,151 | ) | (9,024 | ) | (19,998 | ) | (18,034 | ) | ||||||||
| Loss before provision for income taxes | (48,476 | ) | (52,493 | ) | (67,807 | ) | (18,460 | ) | ||||||||
| Provision for income taxes | 127 | 164 | 294 | 377 | ||||||||||||
| Net loss | $ | (48,603 | ) | $ | (52,657 | ) | $ | (68,101 | ) | $ | (18,837 | ) | ||||
| Basic and diluted net loss per share | $ | (0.36 | ) | $ | (0.40 | ) | $ | (0.50 | ) | $ | (0.14 | ) | ||||
| Weighted average shares outstanding used in computing basic and diluted net loss per share | 136,350 | 131,643 | 136,072 | 131,502 | ||||||||||||
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| Six Months Ended June 30, | ||||||||
| 2016 | 2015 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (68,101 | ) | $ | (18,837 | ) | ||
| Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||||||||
| Non-cash royalty revenue related to sale of future royalties | (14,650 | ) | (8,702 | ) | ||||
| Non-cash interest expense on liability related to sale of future royalties | 10,027 | 10,202 | ||||||
| Stock-based compensation | 12,627 | 9,737 | ||||||
| Depreciation and amortization | 7,634 | 5,833 | ||||||
| Other non-cash transactions | (1,260 | ) | (621 | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable, net | (7,830 | ) | (73 | ) | ||||
| Inventory | 1,084 | 2,828 | ||||||
| Other assets | 4,637 | 190 | ||||||
| Accounts payable | 17 | (10 | ) | |||||
| Accrued compensation | 6,465 | 5,075 | ||||||
| Accrued clinical trial expenses | 5,250 | 1,238 | ||||||
| Other accrued expenses | 2,831 | 1,859 | ||||||
| Interest payable | (54 | ) | - | |||||
| Liability related to refundable upfront payment | 12,500 | - | ||||||
| Deferred revenue | (7,704 | ) | (4,434 | ) | ||||
| Other liabilities | (725 | ) | 11,772 | |||||
| Net cash (used in) provided by operating activities | (37,252 | ) | 16,057 | |||||
| Cash flows from investing activities: | ||||||||
| Purchases of investments | (72,806 | ) | (124,468 | ) | ||||
| Maturities of investments | 107,363 | 111,001 | ||||||
| Sales of investments | - | 5,215 | ||||||
| Purchases of property, plant and equipment | (3,234 | ) | (4,584 | ) | ||||
| Net cash provided by (used in) investing activities | 31,323 | (12,836 | ) | |||||
| Cash flows from financing activities: | ||||||||
| Payment of capital lease obligations | (3,517 | ) | (2,484 | ) | ||||
| Proceeds from shares issued under equity compensation plans | 9,643 | 7,798 | ||||||
| Net cash provided by financing activities | 6,126 | 5,314 | ||||||
| Effect of exchange rates on cash and cash equivalents | (91 | ) | (25 | ) | ||||
| Net increase in cash and cash equivalents | 106 | 8,510 | ||||||
| Cash and cash equivalents at beginning of period | 55,570 | 12,365 | ||||||
| Cash and cash equivalents at end of period | $ | 55,676 | $ | 20,875 | ||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | 10,448 | $ | 8,320 | ||||