NEKTAR THERAPEUTICS SAN FRANCISCO, May 3, 2016 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the first quarter ended March 31, 2016.
Cash and investments in marketable securities at March 31, 2016 were $288.3 million as compared to $308.9 million at December 31, 2015. This balance at March 31, 2016 does not include $28.0 million received from AstraZeneca in April of 2016 for the sublicense of MOVENTIG(TM) to ProStrakan in Europe.
"I am very pleased with the progress of both our proprietary pipeline and partner programs," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK® has performed well in its first year with positive feedback from physicians and patients. ADYNOVATE(TM), which was launched in the U.S. in December 2015 by Baxalta, recently received approval in Japan and has now been filed for approval in Europe. The NKTR-181 Phase 3 efficacy study in patients with chronic low back pain is on track to provide top-line results in early 2017. Finally, NKTR-214, our immuno-oncology candidate, is advancing in its first-in-human trial evaluating its safety and efficacy in cancer patients with solid tumors. We expect to report initial top-line data from the dose-escalation stage of the NKTR-214 study in the second half of 2016."
Revenue for the first quarter of 2016 was $58.9 million as compared to $108.8 million in the first quarter of 2015. Revenue for the first quarter of 2016 includes the recognition of $28.0 million received from AstraZeneca in April of 2016 for the sublicense of MOVENTIG to ProStrakan in Europe which occurred in the first quarter. Revenue in the first quarter of 2015 was higher primarily because of the one-time recognition of $90 million related to the U.S. commercial launch of MOVANTIK(TM). Product sales and royalty revenue increased to $18.2 million in the first quarter of 2016 as compared to $8.1 million in the first quarter of 2015.
Revenue also included non-cash royalty revenue, related to our 2012 royalty monetization, of $6.5 million and $4.0 million for the three months ended March 31, 2016 and 2015, respectively. This non-cash royalty revenue is partially offset by non-cash interest expense also incurred in connection with the 2012 royalty monetization. Non-cash interest expense was $5.0 million in the first quarter 2016 as compared to $5.1 million in the first quarter 2015.
Total operating costs and expenses for the first quarter of 2016 were $68.4 million as compared to $65.8 million in the first quarter of 2015. Total operating costs and expenses increased primarily as a result of higher research and development (R&D) expense in the first quarter of 2016. R&D expense in the first quarter of 2016 was $49.3 million as compared to $47.0 million for the first quarter of 2015 and was higher in the first quarter of 2016 primarily due to expenses for the NKTR-181 Phase 3 studies and for initiation of the Phase 1/2 study of NKTR-214.
General and administrative expense was $10.2 million in the first quarter of 2016 as compared to $10.3 million in the first quarter of 2015.
In Q1 2016, net loss was $19.5 million, or $0.14 loss per share as compared to net income of $33.8 million, or $0.26 basic earnings per share in the first quarter of 2015. This decrease is primarily because of the one-time recognition of $90 million related to the U.S. commercial launch of MOVANTIK(TM) in the first quarter of 2015.
The company also announced upcoming presentations at the following scientific congresses during the first half of 2016:
SMI 16(th) Annual Pain Therapeutics Conference, London, England:
-- Abstract Title: "NKTR-181, A Novel Mu-Opioid Analgesic Designed for
Inherent Low Abuse Liability" presented by Stephen Doberstein, Ph.D.
-- Session: Opioid Dependence
-- Date: May 24, 2016
ASCO Annual Meeting, Chicago, IL:
-- Abstract 11545: "Immune Memory in Nonclinical Models after Treatment
with NKTR-214, an Engineered Cytokine Biased Towards Expansion of CD8+ T
Cells in Tumor", D. Charych, et al.
-- Poster Session: Tumor Biology
-- Date: June 6, 2016, 1:00 p.m. - 4:30 p.m. Central Time
Conference Call to Discuss First Quarter 2016 Financial Results
Nektar management will host a conference call to review the results beginning at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time today, Tuesday, May 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 Friday, June 3, 2016.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 96031147 (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 in pain, oncology, hemophilia and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for MOVANTIK(TM) (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(TM) [Antihemophilic Factor (Recombinant)], a longer-acting PEGylated Factor VIII therapeutic approved in the U.S. in patients over 12 with hemophilia A. 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 nine approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including AstraZeneca's MOVANTIK(TM), Baxalta's ADYNOVATE(TM), 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(TM) is a trademark and MOVENTIG® is a registered trademark of the AstraZeneca group of companies.
ADYNOVATE(TM) is a trademark of Baxalta Inc.
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 advancement of our pipeline, the potential of MOVANTIK and ADYNOVATE, target time frames for availability of future clinical results, and the value and potential of our polymer conjugate 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) the commercial potential of a new drug at the early stages of commercial launch, such as MOVANTIK and ADYNOVATE, is difficult to predict and will have a significant impact on our future results of operation and financial condition; (ii) the timing of the commencement or end of clinical trials and the commercial launch of our drug candidates and those of our partners may be delayed or unsuccessful due to regulatory delays, institutional review board review and approvals, 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) 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; (iv) patents may not issue from our patent applications for our drugs (including MOVANTIK and ADYNOVATE) and drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (v) the outcome of any existing or future intellectual property or other litigation related to our drugs and drug candidates and those of our collaboration partners including MOVANTIK and ADYNOVATE. Other important risks and uncertainties set forth in our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission on February 29, 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)
ASSETS March 31, 2016 December 31, 2015 (1)
-------------- -----------------
Current assets:
Cash and cash
equivalents $72,549 $55,570
Short-term
investments 215,776 253,374
Accounts
receivable, net 39,677 19,947
Inventory 11,250 11,346
Other current
assets 5,593 9,814
Total current
assets 344,845 350,051
Property, plant and equipment, net 69,852 71,336
Goodwill 76,501 76,501
Other assets 681 754
--- ---
Total assets $491,879 $498,642
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable $2,349 $2,363
Accrued
compensation 10,044 5,998
Accrued clinical
trial expenses 10,596 8,220
Other accrued
expenses 6,284 4,156
Interest payable 4,144 4,198
Capital lease
obligations,
current portion 4,782 4,756
Deferred revenue,
current portion 17,240 21,428
Other current
liabilities 10,506 10,127
Total current
liabilities 65,945 61,246
Senior secured notes, net 242,130 241,699
Capital lease obligations, less current portion 3,325 1,073
Liability related to sale of future royalties,
net 114,631 116,029
Deferred revenue, less current portion 59,587 62,426
Other long-term liabilities 6,536 9,740
----- -----
Total
liabilities 492,154 492,213
Commitments and contingencies
Stockholders' equity (deficit):
Preferred stock - -
Common stock 13 13
Capital in excess
of par value 1,888,531 1,876,072
Accumulated other
comprehensive loss (1,835) (2,170)
Accumulated deficit (1,886,984) (1,867,486)
Total
stockholders'
equity
(deficit) (275) 6,429
Total liabilities
and stockholders'
equity (deficit) $491,879 $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 March 31,
----------------------------
2016 2015
---- ----
Revenue:
Product sales $14,099 $7,974
Royalty revenue 4,061 125
Non-cash
royalty
revenue
related to
sale of future
royalties 6,535 3,962
License,
collaboration
and other
revenue 34,187 96,740
------ ------
Total revenue 58,882 108,801
Operating costs
and expenses:
Cost of goods
sold 8,870 8,444
Research and
development 49,268 47,011
General and
administrative 10,228 10,303
Total operating
costs and
expenses 68,366 65,758
------ ------
Income (loss)
from
operations (9,484) 43,043
Non-operating
income
(expense):
Interest
expense (5,677) (4,171)
Non-cash
interest
expense on
liability
related to
sale of future
royalties (5,045) (5,050)
Interest income
and other
income
(expense), net 875 211
--- ---
Total non-
operating
expense, net (9,847) (9,010)
Income (loss)
before
provision for
income taxes (19,331) 34,033
Provision for
income taxes 167 213
--- ---
Net income
(loss) $(19,498) $33,820
======== =======
Net income
(loss) per
share:
$(0.14) $0.26
Basic
$(0.14) $0.25
Diluted
Weighted
average shares
outstanding
used in
computing net
income (loss)
per share:
135,793 131,359
Basic
135,793 135,667
Diluted
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Three Months Ended March
31,
-------------------------
2016 2015
---- ----
Cash flows from
operating
activities:
Net income (loss) $(19,498) $33,820
Adjustments to
reconcile net
income (loss) to
net cash (used
in) provided by
operating
activities:
Non-cash royalty
revenue related
to sale of
future royalties (6,535) (3,962)
Non-cash
interest expense
on liability
related to sale
of future
royalties 5,045 5,050
Stock-based
compensation 6,363 5,177
Depreciation and
amortization 3,715 2,973
Other non-cash
transactions (617) (938)
Changes in
operating assets
and liabilities:
Accounts
receivable, net (19,730) 722
Inventory 96 441
Other assets 4,294 2,809
Accounts payable (34) 2,241
Accrued
compensation 4,046 3,607
Accrued clinical
trial expenses 2,376 1,039
Other accrued
expenses 2,176 1,811
Interest payable (54) (3,750)
Deferred revenue (7,027) 1,993
Other liabilities 1,736 10,279
----- ------
Net cash (used
in) provided by
operating
activities (23,648) 63,312
Cash flows from
investing
activities:
Purchases of
investments (31,452) (24,432)
Maturities of
investments 69,377 73,434
Sales of
investments - 5,215
Purchases of
property, plant
and equipment (1,679) (1,059)
------ ------
Net cash provided
by investing
activities 36,246 53,158
Cash flows from
financing
activities:
Payment of
capital lease
obligations (1,723) (1,098)
Proceeds from
shares issued
under equity
compensation
plans 6,096 1,685
----- -----
Net cash provided
by financing
activities 4,373 587
Effect of
exchange rates
on cash and cash
equivalents 8 30
--- ---
Net increase in
cash and cash
equivalents 16,979 117,087
Cash and cash
equivalents at
beginning of
period 55,570 12,365
Cash and cash
equivalents at
end of period $72,549 $129,452
======= ========
Supplemental
disclosure of
cash flow
information:
Cash paid for
interest $5,244 $7,855
====== ======
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SOURCE Nektar Therapeutics
