Item 1.
Financial Statements
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share
data)
|
|
March 31,
2017
|
|
December 31,
2016
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
243,480
|
|
|
$
|
198,308
|
|
Product royalties receivable
|
|
|
18,426
|
|
|
|
26,261
|
|
Accounts receivable, net
|
|
|
20,537
|
|
|
|
42,998
|
|
Restricted cash
|
|
|
213
|
|
|
|
213
|
|
Inventories, net
|
|
|
22,978
|
|
|
|
23,468
|
|
Prepaid expenses and other current assets
|
|
|
16,725
|
|
|
|
15,984
|
|
Total current assets
|
|
|
322,359
|
|
|
|
307,232
|
|
Investments, non-current
|
|
|
5,556
|
|
|
|
5,495
|
|
Property and equipment, net
|
|
|
6,197
|
|
|
|
6,216
|
|
Intangible assets, net
|
|
|
121,381
|
|
|
|
128,134
|
|
Goodwill
|
|
|
73,022
|
|
|
|
73,022
|
|
Other assets
|
|
|
688
|
|
|
|
752
|
|
Total assets
|
|
$
|
529,203
|
|
|
$
|
520,851
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
8,006
|
|
|
$
|
9,190
|
|
Accrued expenses
|
|
|
17,096
|
|
|
|
12,389
|
|
Accrued interest
|
|
|
2,538
|
|
|
|
129
|
|
Deferred revenue, current
|
|
|
834
|
|
|
|
1,315
|
|
Income tax payable
|
|
|
3,477
|
|
|
|
7,153
|
|
Other current liabilities
|
|
|
2,876
|
|
|
|
2,175
|
|
Total current liabilities
|
|
|
34,827
|
|
|
|
32,351
|
|
Notes payable, non-current
|
|
|
290,979
|
|
|
|
290,516
|
|
Deferred revenue, non-current
|
|
|
1,572
|
|
|
|
805
|
|
Deferred tax liability, net
|
|
|
18,375
|
|
|
|
21,289
|
|
Other liabilities
|
|
|
9,142
|
|
|
|
8,791
|
|
Total liabilities
|
|
|
354,895
|
|
|
|
353,752
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (note 11)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; 5,000,000 shares authorized at March 31, 2017 and
December 31, 2016; no shares issued and outstanding at March 31, 2017 and December 31, 2016
|
|
|
-
|
|
|
|
-
|
|
Class A common stock, $0.01 par value; 270,000,000 shares authorized at March
31, 2017 and December 31, 2016; 46,464,559 and 46,415,749 shares issued and outstanding at March 31, 2017 and December 31,
2016, respectively
|
|
|
464
|
|
|
|
464
|
|
Class B common stock, $0.01 par value; 75,000,000 shares authorized at March 31, 2017 and
December 31, 2016; no shares issued and outstanding at March 31, 2017 and December 31, 2016
|
|
|
-
|
|
|
|
-
|
|
Additional paid-in capital
|
|
|
123,984
|
|
|
|
120,251
|
|
Accumulated other comprehensive income
|
|
|
54,451
|
|
|
|
54,527
|
|
Treasury stock, at cost; 3,009,942 shares at March 31, 2017 and December 31, 2016
|
|
|
(46,269
|
)
|
|
|
(46,269
|
)
|
Retained earnings
|
|
|
41,678
|
|
|
|
38,126
|
|
Total stockholders' equity
|
|
|
174,308
|
|
|
|
167,099
|
|
Total liabilities and stockholders' equity
|
|
$
|
529,203
|
|
|
$
|
520,851
|
|
The accompanying Notes are an integral part
of these Condensed Consolidated Financial Statements.
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Income (Unaudited)
(In thousands, except per share data)
|
|
Three Months Ended March 31,
|
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Product royalty revenue
|
|
$
|
18,435
|
|
|
$
|
16,716
|
|
Product sales revenue
|
|
|
34,154
|
|
|
|
26,595
|
|
Research and development revenue
|
|
|
3,448
|
|
|
|
3,430
|
|
Contract and collaboration revenue
|
|
|
246
|
|
|
|
467
|
|
Total revenues
|
|
|
56,283
|
|
|
|
47,208
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Costs of goods sold
|
|
|
16,883
|
|
|
|
23,338
|
|
Research and development
|
|
|
10,333
|
|
|
|
14,671
|
|
General and administrative
|
|
|
17,691
|
|
|
|
8,927
|
|
Selling and marketing
|
|
|
516
|
|
|
|
775
|
|
Total costs and expenses
|
|
|
45,423
|
|
|
|
47,711
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
10,860
|
|
|
|
(503
|
)
|
Non-operating income (expense):
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
28
|
|
|
|
25
|
|
Interest expense
|
|
|
(2,890
|
)
|
|
|
(6,270
|
)
|
Other income (expense), net
|
|
|
211
|
|
|
|
(347
|
)
|
Total non-operating expense, net
|
|
|
(2,651
|
)
|
|
|
(6,592
|
)
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
|
8,209
|
|
|
|
(7,095
|
)
|
Income tax (provision) benefit
|
|
|
(3,585
|
)
|
|
|
3,038
|
|
Net income (loss)
|
|
$
|
4,624
|
|
|
$
|
(4,057
|
)
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.11
|
|
|
$
|
(0.10
|
)
|
Diluted
|
|
$
|
0.10
|
|
|
$
|
(0.10
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
43,442
|
|
|
|
42,539
|
|
Diluted
|
|
|
62,107
|
|
|
|
42,539
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
4,624
|
|
|
$
|
(4,057
|
)
|
Other comprehensive income (expense):
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on pension benefit obligation
|
|
|
1
|
|
|
|
(8
|
)
|
Foreign currency translation gain (loss)
|
|
|
(77
|
)
|
|
|
15,555
|
|
Comprehensive income
|
|
$
|
4,548
|
|
|
$
|
11,490
|
|
The accompanying Notes are an integral part
of these Condensed Consolidated Financial Statements.
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statement of Changes
in Stockholders’ Equity (Unaudited)
(In thousands, except share data)
|
|
Class A
Common Stock
|
|
Additional
Paid-In
|
|
Accumulated
Other
Comprehensive
|
|
Treasury Stock
|
|
Retained
|
|
Total
Stockholders'
|
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Income
|
|
Shares
|
|
Amount
|
|
Earnings
|
|
Equity
|
Balance at December 31, 2016
|
|
|
46,415,749
|
|
|
$
|
464
|
|
|
$
|
120,251
|
|
|
$
|
54,527
|
|
|
|
3,009,942
|
|
|
$
|
(46,269
|
)
|
|
$
|
38,126
|
|
|
$
|
167,099
|
|
Stock-based compensation expense
|
|
|
-
|
|
|
|
-
|
|
|
|
3,425
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,425
|
|
Stock issued upon exercise of stock options
|
|
|
41,472
|
|
|
|
-
|
|
|
|
240
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
240
|
|
Stock issued under employee stock purchase plan
|
|
|
7,338
|
|
|
|
-
|
|
|
|
68
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
68
|
|
Unrealized gain on pension benefit obligation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1
|
|
Foreign currency translation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(77
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(77
|
)
|
Cumulative-effect adjustment from adoption of ASU 2016-09
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
(1,072
|
)
|
|
|
(1,072
|
)
|
Net income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
4,624
|
|
|
|
4,624
|
|
Balance at March 31, 2017
|
|
|
46,464,559
|
|
|
$
|
464
|
|
|
$
|
123,984
|
|
|
$
|
54,451
|
|
|
|
3,009,942
|
|
|
$
|
(46,269
|
)
|
|
$
|
41,678
|
|
|
$
|
174,308
|
|
The accompanying Notes are an integral part
of these Condensed Consolidated Financial Statements.
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of
Cash Flows (Unaudited)
(In thousands)
|
|
Three Months Ended March 31,
|
|
|
2017
|
|
2016
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
4,624
|
|
|
$
|
(4,057
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
7,422
|
|
|
|
15,573
|
|
Deferred tax provision
|
|
|
(2,915
|
)
|
|
|
2,347
|
|
Stock-based compensation
|
|
|
2,352
|
|
|
|
1,971
|
|
Unrealized currency translations
|
|
|
151
|
|
|
|
4,226
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Product royalties receivable
|
|
|
7,835
|
|
|
|
6,292
|
|
Accounts receivable
|
|
|
22,461
|
|
|
|
7,291
|
|
Inventory
|
|
|
490
|
|
|
|
1,774
|
|
Prepaid and income taxes receivable and payable, net
|
|
|
(3,677
|
)
|
|
|
(3,177
|
)
|
Accounts payable
|
|
|
(1,184
|
)
|
|
|
(6,266
|
)
|
Accrued expenses
|
|
|
4,707
|
|
|
|
(2,067
|
)
|
Accrued interest payable
|
|
|
2,410
|
|
|
|
4,743
|
|
Deferred revenue
|
|
|
286
|
|
|
|
58
|
|
Collaboration obligation
|
|
|
-
|
|
|
|
(425
|
)
|
Other assets and liabilities, net
|
|
|
318
|
|
|
|
(4,546
|
)
|
Net cash provided by operating activities
|
|
|
45,280
|
|
|
|
23,737
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Convertible note receivable
|
|
|
-
|
|
|
|
(5,000
|
)
|
Changes in restricted cash
|
|
|
-
|
|
|
|
10,598
|
|
Payment of squeeze-out liability for non-tendering R-Tech shareholders
|
|
|
-
|
|
|
|
(8,213
|
)
|
Purchases of property and equipment
|
|
|
(350
|
)
|
|
|
(735
|
)
|
Net cash used in investing activities
|
|
|
(350
|
)
|
|
|
(3,350
|
)
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Payments of notes payable
|
|
|
-
|
|
|
|
(17,574
|
)
|
Changes in restricted cash
|
|
|
-
|
|
|
|
17,676
|
|
Proceeds from exercise of stock options
|
|
|
240
|
|
|
|
757
|
|
Proceeds from employee stock purchase plan
|
|
|
68
|
|
|
|
58
|
|
Net cash provided by financing activities
|
|
|
308
|
|
|
|
917
|
|
Effect of exchange rates on cash and cash equivalents
|
|
|
(66
|
)
|
|
|
489
|
|
Net increase in cash and cash equivalents
|
|
|
45,172
|
|
|
|
21,793
|
|
Cash and cash equivalents at beginning of period
|
|
|
198,308
|
|
|
|
108,284
|
|
Cash and cash equivalents at end of period
|
|
$
|
243,480
|
|
|
$
|
130,077
|
|
The accompanying Notes are an integral part
of these Condensed Consolidated Financial Statements.
1. Business Organization and Basis of
Presentation
Description of the Business
Sucampo Pharmaceuticals,
Inc., (Company) is a global biopharmaceutical company focused on developing, identifying, acquiring and bringing to market innovative
medicines that meet unmet medical needs. Our primary focus areas are medicines that treat gastrointestinal, ophthalmic, neurological,
and oncology disorders.
The Company currently
generates revenue mainly from product royalties, upfront and milestone payments, product sales and reimbursements for development
activities. The Company expects to continue to incur significant expenses for the next several years as the Company continues its
research and development activities, seeks additional regulatory approvals and additional indications for approved products and
other compounds, seeks strategic opportunities for acquiring new products and product candidates.
AMITIZA
®
(lubiprostone) is being marketed for three gastrointestinal indications under the collaboration and license agreement (as amended
in October 2014, the North America Takeda Agreement) with Takeda Pharmaceutical Company Limited (Takeda). These indications are
chronic idiopathic constipation (CIC) in adults, irritable bowel syndrome with constipation (IBS-C) in adult women and opioid-induced
constipation (OIC) in adults suffering from chronic non-cancer related pain. Under the North America Takeda Agreement, the Company
is primarily responsible for clinical development activities, while Takeda is responsible for commercialization of AMITIZA in the
United States (U.S.) and Canada. The Company and Takeda initiated commercial sales of AMITIZA in the U.S. for the treatment of
CIC in April 2006, for the treatment of IBS-C in May 2008 and for the treatment of OIC in May 2013. Takeda is required to provide
a minimum annual commercial investment during the current term of the North America Takeda Agreement and may reduce the minimum
annual commercial investment when a generic equivalent enters the market. In October 2015, Health Canada approved AMITIZA for CIC
in adults. In October 2014, the Company and Takeda executed amendments to the North America Takeda Agreement which, among other
things, extended the term of the North America Takeda Agreement beyond December 2020. During the extended term beginning in January
2021, Takeda and the Company will split the annual net sales revenue of the branded AMITIZA products.
We have also partnered
with Par Pharmaceuticals, Inc., or Par, and Dr. Reddy’s Laboratories, Ltd., or Dr. Reddy’s, in connection with the
settlement of patent litigation in the United States related to our AMITIZA 8 mcg and 24 mcg soft gelatin capsule products. Under
our agreement with Par, we granted Par a non-exclusive license to market Par’s generic version of lubiprostone 8 mcg and
24 mcg soft gelatin capsules in the United States for the indications approved for AMITIZA beginning January 1, 2021, or earlier
under certain circumstances. Beginning on January 1, 2021, Par will split with us the gross profits of the licensed products sold
during the term of the agreement, which continues until each of our related patents has expired. Under our agreement with Dr. Reddy’s,
we granted Dr. Reddy’s a non-exclusive license to market Dr. Reddy’s generic version of lubiprostone 8 mcg and 24 mcg
soft gelatin capsules in the United States for the indications approved for AMITIZA. This license does not begin until more than
six years from November 9, 2016, or earlier under certain circumstances. Dr. Reddy’s will pay to us a share of net profits
of generic lubiprostone products sold during the term of the agreement, which decreases over time and ends when all of our related
patents have expired. In the event that either Par or Dr. Reddy’s elect to launch an authorized generic form of lubiprostone,
we have agreed to supply such product under the terms of a manufacturing and supply agreement at a negotiated price.
In Japan, AMITIZA
is marketed under a license, commercialization and supply agreement (the Japan Mylan Agreement) that was transferred to Mylan,
Inc. (Mylan) from Abbott Laboratories, Inc. (Abbott), as of February 2015, as part of Mylan’s acquisition of a product portfolio
from Abbott. The Company received approval of its new drug application (NDA) for AMITIZA for the treatment of chronic constipation
(CC), excluding constipation caused by organic diseases, from Japan’s Ministry of Health, Labour and Welfare in June 2012
and pricing approval in November 2012. AMITIZA is Japan’s only prescription medicine for CC. The Company did not experience
any significant changes in the commercialization of AMITIZA in Japan as a result of the transfer of the Japan Mylan Agreement from
Abbott to Mylan.
In May 2015, the Company
entered into an exclusive license, development, commercialization and supply agreement (the China Gloria Agreement) with Harbin
Gloria Pharmaceuticals Co., Ltd. (Gloria), for AMITIZA in the People’s Republic of China. Under the China Gloria Agreement,
Gloria is responsible for all development activities and costs, as well as commercialization and regulatory activities, for AMITIZA
in the People’s Republic of China. The Company will be the exclusive supplier of AMITIZA to Gloria at an agreed upon supply
price. Upon entering into the China Gloria Agreement, the Company received an upfront payment of $1.0 million. In June 2015, the
China Food and Drug Administration accepted an Investigational New Drug (IND) application for a pivotal trial of AMITIZA in patients
with CIC; as a result, the Company received an additional payment of $500,000 from Gloria. In addition to the $1.5 million in payments
received and recognized as revenue through June 2015, the Company is eligible to receive an additional payment in the amount of
$1.5 million upon the occurrence of a specified regulatory or commercial milestone event.
In October 2014, the
Company entered into an exclusive license, development, commercialization and supply agreement (the Global Takeda Agreement) for
lubiprostone with Takeda, through which Takeda has the exclusive rights to further develop and commercialize AMITIZA in all global
markets, except the U.S., Canada, Japan and the People’s Republic of China. Takeda became the marketing authorization holder
in Switzerland in April 2015, in the United Kingdom, Austria, Belgium, Germany, Netherlands, Ireland, Italy, Luxembourg and Spain
during 2016.
Before the execution
of the Global Takeda Agreement, the Company retained full rights to develop and commercialize AMITIZA for the rest of the world’s
markets outside of the U.S., Canada and Japan. In the U.K., the Company received approval in September 2012 from the Medicines
and Healthcare Products Regulatory Agency (MHRA) for the use of AMITIZA to treat CIC. The Company made AMITIZA available in the
U.K. in the fourth quarter of 2013. In July 2014, National Institute of Health and Care Excellence (NICE) published the technology
appraisal guidance recommending the use of AMITIZA in the treatment of CIC and associated symptoms in adults who have failed laxatives.
In January 2015, the Company successfully completed the European mutual recognition procedure (MRP) for AMITIZA for the treatment
of CIC in select European countries, resulting in marketing authorizations in these countries.
In Switzerland, AMITIZA
was approved to treat CIC in 2009. In 2012, the Company reached an agreement with the Bundesamt fur Gesundheit, (BAG), the Federal
Office of Public Health in Switzerland, on a reimbursement price for AMITIZA in Switzerland, and began active marketing in the
first quarter of 2013. In February 2014, the Company announced that the BAG revised several reimbursement limitations with which
AMITIZA was first approved for reimbursement and inclusion in the Spezialitätenliste (SL) to allow all Swiss physicians to
prescribe AMITIZA to patients who have failed previous treatments with at least two laxatives over a nine-month period. In July
2014, AMITIZA was approved for the treatment of OIC in chronic, non-cancer adult patients by the Swissmedic, the Swiss Agency for
Therapeutic Products, and in October 2015, the BAG added this indication to the SL.
In October 2015, Takeda
obtained approval of the clinical trial application (CTA) for AMITIZA for the treatment of CIC and IBS-C in Russia that was submitted
in June 2015. In December 2015, a CTA was filed for AMITIZA for the treatment of CIC, IBS-C and OIC in Mexico and South Korea.
Takeda initiated Phase 3 registration trials in Russia in March 2016 and in South Korea and Mexico in May 2016. An NDA for the
treatment of CIC, IBS-C, and OIC was submitted in Israel in June 2015, and approved in July 2016, and in Kazakhstan in December
2015. Additional NDA submissions have been made by Takeda in Singapore in May 2016, and South Africa and Indonesia in June 2016,
and are planned in various other markets for 2017 and beyond.
In the U.S., the Company
ceased marketing RESCULA in the fourth quarter of 2014 and no product was made available after the March 2015 expiration date.
In May 2015, the Company returned all licenses for unoprostone isopropyl to R-Tech. As part of the acquisition of R-Tech in October
2015, the Company acquired all rights to RESCULA. RESCULA is being commercialized by Santen Pharmaceutical Co., Ltd in Japan, and
Zuellig Pharma Inc. in Taiwan.
The Company’s
other clinical development programs include the following:
Lubiprostone
Alternate Formulation
The Company has been
developing an alternate formulation of lubiprostone for both adult and pediatric patients who are unable to take or do not tolerate
capsules and for naso-gastric tube fed patients. Takeda has agreed to fund 100% of the costs, up to a cap, of this alternate formulation
work. We initiated the Phase 3 program of the alternate formulation of lubiprostone in adults in the second half of 2016 and, if
the program is successful, we intend to file an NDA in the United States for the alternate formulation for adults in the second
half of 2017.
Lubiprostone
for Pediatric Functional Constipation
The Phase 3 program
required to support an application for marketing authorization of lubiprostone for pediatric functional constipation comprises
four clinical trials. The first two trials, one of which was recently completed, test the soft gelatin capsule formulation of lubiprostone
in patients 6 to 17 years of age. The first of these trials was a pivotal 12-week, randomized, placebo-controlled trial which was
initiated in December 2013 and completed enrollment in April 2016. The second trial is a follow-on, long-term safety extension
trial that was initiated in March 2014. In November 2016, we announced that the Phase 3 trial of AMITIZA in pediatric functional
constipation in children 6 to 17 years of age failed to achieve its primary endpoint of overall spontaneous bowel movement, or
SBM, response. The trial achieved statistical significance for some secondary endpoints, notably overall SBM frequency, straining,
and stool consistency. In addition, in this study lubiprostone was well tolerated. We have entered into a process with the U.S.
Food and Drug Administration, or FDA, and other constituencies, and as a result of initial discussion with the FDA expect to submit
a supplemental NDA in the second half of 2017. Additionally, after further consultations with the FDA to better determine the doses
and endpoints that should be studied, the Phase 3 program for the alternate formulation of lubiprostone described above will be
followed in mid-2018 with a Phase 3 program in patients 6 months to 6 years of age using the alternate formulation. Takeda has
agreed to fund 70% of the costs, up to a cap, of this pediatric functional constipation program.
CPP 1-X/Sulindac
Combination Product
In
January 2016, the Company entered into an option and collaboration agreement under which Cancer Prevention Pharmaceuticals,
Inc. (CPP) granted the Company the sole option to acquire an exclusive license to commercialize CPP-1X/sulindac combination
product in North America. This product is currently in a Phase 3 clinical trial, which is being conducted by CPP for the
treatment of familial adenomatous polyposis (FAP). Under the agreement with CPP, the Company has the exclusive option to
license this product in North America. There are currently no approved treatments for FAP. The ongoing Phase 3 study
is a 150-patient, three-arm, double-blind, randomized trial of the combination agent and the single agent comparators.
Enrollment in the study has completed and the results from a Phase 3 futility analysis are expected to be available mid-2017.
Results from the clinical trial are expected at the end of 2018.
VTS-270 for
Niemann-Pick Disease Type C1 (NPC-1)
On
March 31, 2017, the Company entered into an Agreement and Plan of Merger with Vtesse Inc. (“Vtesse”) a privately-held
rare disease company. Following the closing of this acquisition on April 3, 2017, the Company gained Vtesse’s lead product
candidate, known as VTS-270. VTS-270 is a well-characterized mixture of 2-hydroxypropyl-ß-cyclodextrins (HPßCD) with
a specific compositional fingerprint that distinguishes it from other HPßCD mixtures. It is administered by an intrathecal
infusion to directly address the neurological manifestations of disease. Preclinical and early clinical studies suggest that the
administration of VTS-270 may slow or stop certain indicators of NPC-1, an ultra-orphan, progressive and fatal disease caused by
a defect in lipid transport within the cell. VTS-270, which is currently in a fully-enrolled pivotal Phase 2b/3 trial, has been
granted breakthrough therapy designation in the United States and orphan designation in both the United States and EU. Effective
treatment of NPC-1 remains a high unmet need, with no approved products for patients in the United States. Results from the pivotal
trial are expected in mid-2018.
The Company expects
to account for the transaction as an asset acquisition and expects to incur an acquired in-process research and development charge
of $180.0 million to $200.0 million (and no related current tax benefit) in the second quarter of 2017.
Basis of Presentation
The accompanying unaudited
Condensed Consolidated Financial Statements have been prepared in accordance with generally accepted accounting principles in the
United States of America (GAAP) and the rules and regulations of the U.S. Securities and Exchange Commission (SEC) for interim
financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements and should be read in conjunction with the Company’s Consolidated Financial Statements as of and for the year
ended December 31, 2016 included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on March 8, 2017.
The financial information as of March 31, 2017 and for the three months ended March 31, 2017 and 2016 is unaudited. The year-end
condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP.
In the opinion of the Company’s management, all adjustments, consisting only of normal recurring adjustments or accruals,
considered necessary for a fair statement of the results of these interim periods have been included. The results of the Company’s
operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period
or for a full fiscal year.
The Condensed Consolidated
Financial Statements include the accounts of the Company and its wholly-owned subsidiaries: Sucampo AG (SAG) based in Zug, Switzerland,
through which the Company conducts certain of its worldwide and European operations; Sucampo Pharma, LLC (SPL) based in Osaka,
Japan, through which the Company conducts its Asian operations, manufacturing and certain development operations; and Sucampo Pharma
Americas LLC (SPA), based in Rockville, Maryland, through which the Company conducts its North American operations. All inter-company
balances and transactions have been eliminated.
The preparation of
financial statements in conformity with GAAP requires management to make estimates that affect the reported amounts of assets and
liabilities at the date of the financial statements, disclosure of contingent assets and liabilities, and the reported amounts
of revenue and expenses during the reporting period. Actual results could differ from those estimates.
2. Summary of Significant Accounting
Policies
Certain Risks, Concentrations and
Uncertainties
Financial instruments
that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents, restricted
cash and receivables. The Company places its cash, cash equivalents and restricted cash with highly rated financial institutions.
As of March 31, 2017 and December 31, 2016, approximately $1.1 million or less than 1%, and $1.2 million or less than 1%, respectively,
of the Company’s cash, cash equivalents, and restricted cash were issued or insured by the United States government or other
government agencies. The Company has not experienced any losses on these accounts related to amounts in excess of insured limits.
Revenues from Takeda,
an unrelated party, accounted for 59.1% and 61.5% of the Company’s total revenues for the three months ended March 31, 2017
and 2016, respectively. Accounts receivable and product royalties receivable from Takeda accounted for 77.7% and 69.6% of the Company’s
total accounts receivable and product royalties receivable at March 31, 2017 and December 31, 2016, respectively.
Revenues from another
unrelated party, Mylan, accounted for 35.6% and 30.6% of the Company’s total revenues for the three months ended March 31,
2017 and 2016, respectively. Accounts receivable from Mylan accounted for 17.5% and 30.1% of the Company’s total accounts
receivable and product royalties receivable at March 31, 2017 and December 31, 2016, respectively.
The Company depends
significantly upon collaborations with Takeda and Mylan, and its activities may be impacted if these relationships are disrupted.
Fair Value of Financial Instruments
The carrying values
of the Company’s financial instruments approximate their fair values due to their short maturities, independent valuations
or internal assessments. The Company’s financial instruments include cash and cash equivalents, restricted cash, receivables,
accounts payable and other accrued liabilities. The Company’s investment in CPP is measured at fair value on a recurring
basis, and the Company estimates the fair value of its long-term debt based on similar types of borrowings.
Variable Interest Entities
The Company performs
initial and on-going evaluations of the entities with which it has variable interests, such as equity ownership, in order to identify
entities (i) that do not have sufficient equity investment at risk to permit the entity to finance its activities without additional
subordinated financial support or (ii) in which the equity investors lack an essential characteristic of a controlling financial
interest. Such entities are classified as variable interest entities (VIE’s). If an entity is identified as a VIE, the Company
performs an assessment to determine whether the Company has both (i) the power to direct activities that most significantly impact
the VIE’s economic performance and (ii) have the obligation to absorb losses from or the right to receive benefits of the
VIE that could potentially be significant to the VIE. If both of these criteria are satisfied, the Company is identified as the
primary beneficiary of the VIE. As of March 31, 2017 and December 31, 2016, Cancer Prevention Pharmaceuticals, Inc. (“CPP”),
in which the Company held a variable interest, was determined to be a VIE; however, the Company does not have the power to direct
CPP’s economic performance.
Recent Accounting Pronouncements
In May 2014, the Financial
Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue
from Contracts with Customers”, which will replace numerous requirements in U.S. GAAP, including industry-specific requirements.
This guidance provides a five-step model to be applied to all contracts with customers, with an underlying principle that an entity
will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled
to in exchange for those goods or services. ASU No. 2014-09 requires extensive quantitative and qualitative disclosures covering
the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including disclosures on
significant judgments made when applying the guidance. This guidance is effective for annual reporting periods beginning after
December 15, 2017 and interim periods therein. Early adoption is permitted for reporting periods and interim periods therein, beginning
after December 15, 2016. An entity can elect to apply the guidance under one of the following two methods: (i) retrospectively
to each prior reporting period presented – referred to as the full retrospective method or (ii) retrospectively with the
cumulative effect of initially applying the standard recognized at the date of initial application in retained earning –
referred to as the modified retrospective method. While the Company has not yet completed its final review of the impact of the
new standard, the adoption of ASU No. 2014-09 could potentially have the following impacts to our contracts:
|
(i)
|
Variable consideration including milestone payments, escalating royalty payments based on volume,
and product sales price adjustments may be recognized at an earlier point in time under the new guidance, when it is probable that
the variable consideration will be achieved without a significant future reversal of cumulative revenue expected.
|
|
(ii)
|
Expense reimbursement revenue of certain R&D projects may result in a change in presentation.
|
The Company continues to evaluate the impact
of adoption, the implementation approach to be used and the applicable disclosure requirements, which will be significant and quite
comprehensive. The Company plans to adopt the new standard effective January 1, 2018, and will continue to monitor additional changes,
modifications, clarifications or interpretations by the FASB, which may impact the Company’s current conclusions.
In July 2015, the
FASB issued ASU No. 2015-11, "Inventory (Topic 330): Simplifying the Measurement of Inventory." ASU No. 2015-11 applies
only to inventory for which cost is determined by methods other than last in, first-out and the retail inventory method, which
includes inventory that is measured using first-in, first-out or average cost. Inventory within the scope of this standard is required
to be measured at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary
course of business, less reasonably predictable costs of completion, disposal, and transportation. The new standard is effective
for the Company’s calendar year beginning January 1, 2017. The adoption of this standard had no impact on the Company’s
consolidated financial statements.
In March 2016, the
FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting,” which changes the accounting
for certain aspects of share-based payments to employees. The new guidance requires excess tax benefits and tax deficiencies to
be recorded in the statement of operations when the awards vest or are settled. In addition, cash flows related to excess tax benefits
will no longer be separately classified as a financing activity apart from other income tax cash flows. The standard also clarifies
that all cash payments made on an employee’s behalf for withheld shares should be presented as a financing activity on the
statement of cash flows, and provides an accounting policy election to account for forfeitures as they occur. The new standard
is effective for the Company’s calendar year beginning January 1, 2017. On January 1, 2017, as a result of adopting ASU No.
2016-09, the Company recorded a cumulative-effect adjustment of $1.1 million between retained earnings and additional paid in capital.
Additionally, a retrospective adjustment to the Company’s statement of cash flows for the three months ended March 31, 2016
resulted in an increase of $180,000 to net cash provided by operating activities and a decrease of $180,000 to net cash provided
by financing activities.
In January 2017, the
FASB issued ASU No. 2017-01, “Clarifying the Definition of a Business,” This definition is used in determining whether
acquisitions are accounted for as business combinations or as the acquisition of assets. This standard modifies the definition
of a business, including providing a screen to determine when an acquired set of assets and activities is not a business. The screen
requires that when substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset
or a group of similar identifiable assets, the set is not a business. The standard also makes other modifications to clarify what
must be included in an acquired set for it to be a business and how to evaluate the set to determine whether it is a business.
Our acquisitions subsequent to December 31, 2016, are subject to the application of the modified definition.
In January 2017, the
FASB issued ASU No. 2017-04, “Intangibles - Goodwill and Other (Topic 350): Simplifying the test for goodwill impairment.”
ASU No. 2017-04 simplifies the subsequent measurement of goodwill by eliminating Step 2 in the step quantitative test and record
an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value. ASU 2017-04 will be applied
prospectively and is effective for annual and interim goodwill impairment tests conducted in fiscal years beginning after December
15, 2019. The new standard is effective for the Company for its fiscal 2021 fourth quarter goodwill impairment test. Early adoption
is permitted for annual and interim goodwill impairment testing dates after January 1, 2017. The Company elected to early adopt
ASU No. 2017-04 on January 1, 2017. The adoption had no impact on the Company’s consolidated financial statements.
3. Net Income (loss) per Share
Basic net income (loss)
per share is computed by dividing net income (loss) by the weighted average common shares outstanding. Diluted net income per share
is computed by dividing net income by the sum of the weighted average common shares and potential dilutive common shares outstanding.
Diluted net loss per share is computed by dividing net loss by the weighted average common shares outstanding without the impact
of potential dilutive common shares outstanding because they would have an anti-dilutive impact on diluted net loss per share.
The treasury-stock method is used to determine the dilutive effect of the Company’s stock option grants, and the if-converted
method is used to determine the dilutive effect of the Company’s Convertible Notes.
The computation of
net income (loss) per share for the three months ended March 31, 2017 and 2016 is shown below.
|
|
Three Months Ended March 31,
|
(In thousands, except per share data)
|
|
2017
|
|
2016
|
Basic net income (loss) per share:
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
4,624
|
|
|
$
|
(4,057
|
)
|
Weighted-average number of common shares-basic
|
|
|
43,442
|
|
|
|
42,539
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share
|
|
$
|
0.11
|
|
|
$
|
(0.10
|
)
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share:
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
4,624
|
|
|
$
|
(4,057
|
)
|
Interest expense applicable to convertible debt, net of tax
|
|
|
1,438
|
|
|
|
-
|
|
Amortization of debt issuance costs, net of tax
|
|
|
282
|
|
|
|
-
|
|
Net income for calculation of diluted net income (loss) per share
|
|
$
|
6,344
|
|
|
$
|
(4,057
|
)
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares-basic
|
|
|
43,442
|
|
|
|
42,539
|
|
Assumed exercise of stock options under the treasury-stock method
|
|
|
586
|
|
|
|
-
|
|
Assumed shares under if-converted method
|
|
|
18,079
|
|
|
|
-
|
|
Weighted-average number of common shares-diluted
|
|
|
62,107
|
|
|
|
42,539
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share
|
|
$
|
0.10
|
|
|
$
|
(0.10
|
)
|
The following securities
were excluded from the computation of diluted net income (loss) per share as their effect would have been anti-dilutive for the
three months ended March 31, 2017 and 2016:
|
|
Three Months Ended March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Employee stock options
|
|
|
4,126
|
|
|
|
5,537
|
|
4. Segment Information
The Company has one
operating segment which is the development and commercialization of pharmaceutical products. Summarized product category and geographic
information is shown in the tables below.
Product Category
Information
Revenues for product
categories are attributed based on the following categories.
Product royalty revenue
represents royalty revenue earned on the net sales of AMITIZA in North America. Product sales revenue represents drug product net
sales of AMITIZA in North America, Japan and Europe and drug product net sales of RESCULA in Japan. Research and development revenue
represents funded development work primarily related to AMITIZA. Contract and collaboration revenue represents the amortization
of up-front payments under the North America Takeda Agreement and release of the collaboration obligation under the Global Takeda
agreement.
Company revenues by
product category for the three months ended March 31, 2017 and 2016 were as follows:
|
|
Three Months Ended March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Product royalty revenue
|
|
$
|
18,435
|
|
|
$
|
16,716
|
|
Product sales revenue - AMITIZA
|
|
|
31,340
|
|
|
|
23,434
|
|
Product sales revenue - RESCULA
|
|
|
2,814
|
|
|
|
3,161
|
|
Research and development revenue
|
|
|
3,448
|
|
|
|
3,430
|
|
Contract and collaboration revenue
|
|
|
246
|
|
|
|
467
|
|
Total
|
|
$
|
56,283
|
|
|
$
|
47,208
|
|
Geographical Information
Revenues are attributable
to countries based on the location of the customer. The Company operates a manufacturing facility in Japan that supplies products
to customers as well as the Company’s subsidiaries in other countries. The sales from the manufacturing operations to other
countries are included in the net sales of the country in which the manufacturing location is based. All intercompany sales are
excluded to derive consolidated revenues. The Company’s country of domicile is the United States.
Company revenues by
geographic location for the three months ended March 31, 2017 and 2016 were as follows:
|
|
Three Months Ended March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
United States
|
|
$
|
33,199
|
|
|
$
|
28,939
|
|
Japan
|
|
|
22,885
|
|
|
|
17,848
|
|
Rest of the world
|
|
|
199
|
|
|
|
421
|
|
Total
|
|
$
|
56,283
|
|
|
$
|
47,208
|
|
The Company’s
long-lived assets by geographic location where located on March 31, 2017 and December 31, 2016 were as follows:
(In thousands)
|
|
March 31,
2017
|
|
December 31,
2016
|
United States
|
|
$
|
2,933
|
|
|
$
|
3,065
|
|
Japan
|
|
|
3,235
|
|
|
|
3,119
|
|
Rest of the world
|
|
|
29
|
|
|
|
32
|
|
Total
|
|
$
|
6,197
|
|
|
$
|
6,216
|
|
5. Fair Value measurements
The Company performs
fair value measurements in accordance with the FASB’s guidance for fair value measurements and disclosures, which defines
fair value as the exchange price that would be received for selling an asset or paid to transfer a liability in the principal or
most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
A fair value hierarchy is established which requires the Company to maximize the use of observable inputs and minimize the use
of unobservable inputs when measuring fair value. The Company classifies its assets and liabilities into the following categories
based on the three levels of inputs used to measure fair value:
Level 1
: Observable
inputs, such as quoted prices in active markets for identical assets or liabilities;
Level 2
: Inputs,
other than the quoted price in active markets, that are observable, either directly or indirectly, such as quoted prices in active
markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not
active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of
the assets or liabilities; or
Level 3
: Unobservable
inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
The carrying values
of cash and cash equivalents, restricted cash, accounts receivable, product royalties receivable, accounts payable and other accrued
liabilities, approximate their fair values due to their short maturities.
The Company has elected
the fair value option on its investment in CPP; as such, it is measured at fair value on a recurring basis. At March 31, 2017,
the estimated fair value of the investment in CPP was $5.3 million. For the three months ended March 31, 2017, the Company recorded
$0.1 million in other income due to the increase in fair value of the investment in CPP.
The estimated fair
value of long term debt at March 31, 2017 was $297.0 million, and was based on similar types of borrowings.
The estimated fair
values may not represent actual values of the financial instruments that could be realized as of the balance sheet date or that
will be realized in the future. As of March 31, 2017 and December 31, 2016, there were no financial instruments measured at fair
value on a non-recurring basis.
6. Inventory
Inventories are valued
under a standard costing method and are stated at the lower of cost or net realizable value. Inventories consist of raw materials,
work-in-process and finished goods. The Company’s inventories include the direct purchase cost of materials and supplies
and manufacturing overhead costs.
Inventory consisted
of the following at March 31, 2017 and December 31, 2016:
(In thousands)
|
|
March 31,
2017
|
|
December 31,
2016
|
Raw materials
|
|
$
|
3,316
|
|
|
$
|
1,414
|
|
Work in process
|
|
|
18,134
|
|
|
|
18,045
|
|
Finished goods
|
|
|
1,528
|
|
|
|
4,009
|
|
Total
|
|
$
|
22,978
|
|
|
$
|
23,468
|
|
7. Investments, non-current
Investment in CPP
In 2016, the Company
entered into a Securities Purchase Agreement (“CPP Securities Agreement”) and an Option and Collaboration Agreement
(“CPP Agreement”) with CPP for the development and commercialization of CPP-1X/sulindac combination.
Under the terms of
the CPP Securities Agreement, the Company provided $5.0 million to CPP in exchange for a convertible note. The convertible note
bears interest at the rate of 5% per annum and matures on January 31, 2019 unless earlier converted or prepaid. Under the terms
of the CPP Agreement, CPP granted the Company the sole option to acquire an exclusive license to commercialize CPP-1X/sulindac
combination product in North America.
CPP is considered
to be a VIE with respect to the Company. It has been determined that the power to direct the activities that most significantly
impact CPP’s economic performance is held by the board of directors of CPP. The Company does not have a representative on
CPP’s board and does not have the right to appoint or elect such a representative. Therefore, the Company is not the primary
beneficiary of CPP, and the entity is not consolidated with the financial statements of the Company.
The Company’s
maximum exposure to loss as a result of its involvement with CPP was $5.3 million and $5.2 million as of March 31, 2017, and December
31, 2016, respectively.
The Company has elected
the fair value option on the convertible note received from CPP due to the nature of the financial characteristics of the investment.
As of March 31, 2017 and December 31, 2016, the fair value of the convertible note was $5.3 million and $5.2 million, respectively.
8. Intangible
Assets and Goodwill
Intangible assets
by major class consisted of the following as of March 31, 2017 and December 31, 2016:
|
|
March 31, 2017
|
|
December 31, 2016
|
(In thousands)
|
|
Weighted
average life
(in months)
|
|
Carrying
amount
|
|
Weighted
average life
(in months)
|
|
Carrying
amount
|
Amortized intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent and license rights
|
|
|
57
|
|
|
$
|
10,513
|
|
|
|
60
|
|
|
$
|
10,513
|
|
Manufacturing know-how
|
|
|
62
|
|
|
|
134,600
|
|
|
|
65
|
|
|
|
134,600
|
|
Accumulated amortization
|
|
|
|
|
|
|
(40,895
|
)
|
|
|
|
|
|
|
(34,142
|
)
|
Impairment losses
|
|
|
|
|
|
|
(5,651
|
)
|
|
|
|
|
|
|
(5,651
|
)
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
22,814
|
|
|
|
|
|
|
|
22,814
|
|
Total amortized intangible assets
|
|
|
|
|
|
$
|
121,381
|
|
|
|
|
|
|
$
|
128,134
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
|
|
|
$
|
73,022
|
|
|
|
|
|
|
$
|
73,022
|
|
Total unamortized intangible assets
|
|
|
|
|
|
$
|
73,022
|
|
|
|
|
|
|
$
|
73,022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
|
|
|
|
$
|
194,403
|
|
|
|
|
|
|
$
|
201,156
|
|
The changes in intangible
assets for the three months ended March 31, 2017 are as follows:
(In thousands)
|
|
Intangibles
|
|
Goodwill
|
Balance at December 31, 2016
|
|
$
|
128,134
|
|
|
$
|
73,022
|
|
Amortization
|
|
|
(6,753
|
)
|
|
|
-
|
|
Balance at March 31, 2017
|
|
$
|
121,381
|
|
|
$
|
73,022
|
|
9. Accrued Expenses and Other Current
Liabilities
Accrued expenses consisted
of the following at March 31, 2017 and December 31, 2016:
(In thousands)
|
|
March 31,
2017
|
|
December 31,
2016
|
Research and development costs
|
|
$
|
5,224
|
|
|
$
|
3,030
|
|
Employee compensation
|
|
|
3,647
|
|
|
|
7,513
|
|
Legal and accounting fees
|
|
|
1,756
|
|
|
|
622
|
|
Consulting fees
|
|
|
6,148
|
|
|
|
-
|
|
Restructuring
|
|
|
-
|
|
|
|
163
|
|
Other accrued expenses
|
|
|
321
|
|
|
|
1,061
|
|
Total
|
|
$
|
17,096
|
|
|
$
|
12,389
|
|
Other current liabilities
consisted of the following at March 31, 2017 and December 31, 2016:
(In thousands)
|
|
March 31,
2017
|
|
December 31,
2016
|
Indirect taxes payable
|
|
$
|
2,425
|
|
|
$
|
1,756
|
|
Squeeze out liability for non-tendering R-Tech shareholders
|
|
|
154
|
|
|
|
155
|
|
Other current liabilities
|
|
|
297
|
|
|
|
264
|
|
Total
|
|
$
|
2,876
|
|
|
$
|
2,175
|
|
10. Restructuring
In December 2015,
the Company adopted a plan to restructure certain of its operations and to consolidate certain functions in the Company’s
corporate headquarters located in Rockville, Maryland and in the Company’s Japanese subsidiaries. The restructuring plan
primarily included headcount reductions due to the ongoing integration of R-Tech. In connection with these restructuring activities,
the Company recorded restructuring charges of $365,000 and $183,000 for the three months ended March 31, 2017 and 2016, respectively.
These costs are reflected within general and administrative expenses and consisted primarily of termination benefits.
The changes in accrued
restructuring costs for the three months ended March 31, 2017 are as follows:
(In thousands)
|
|
Accrued
Restructuring
|
Balance at December 31, 2016
|
|
$
|
163
|
|
Expenses incurred
|
|
|
365
|
|
Amounts paid
|
|
|
(528
|
)
|
Balance at March 31, 2017
|
|
$
|
-
|
|
The Company does not
expect to record any additional restructuring charges under this plan. The Company has incurred total restructuring charges under this plan of
$3.7 million through March 31, 2017.
11. Other Liabilities
Other liabilities
consisted of the following at March 31, 2017 and December 31, 2016:
(In thousands)
|
|
March 31,
2017
|
|
December 31,
2016
|
Deferred grants
|
|
$
|
750
|
|
|
$
|
750
|
|
Unrecognized tax benefits
|
|
|
4,182
|
|
|
|
4,060
|
|
Deferred leasehold incentive
|
|
|
1,582
|
|
|
|
1,582
|
|
Defined benefit obligation
|
|
|
832
|
|
|
|
818
|
|
Lease liability
|
|
|
1,388
|
|
|
|
1,183
|
|
Other
|
|
|
408
|
|
|
|
398
|
|
Total
|
|
$
|
9,142
|
|
|
$
|
8,791
|
|
12. Convertible
Notes Payable
On December 27, 2016,
the Company issued $300.0 million aggregate principal amount of its 3.25% Convertible Senior Notes due 2021 (the “Convertible
Notes”). Interest is payable semi-annually in cash in arrears on June 15 and December 15 of each year, beginning on June
15, 2017, at a rate of 3.25% per year. The Convertible Notes mature on December 15, 2021 unless earlier converted or repurchased,
are not redeemable prior to the maturity date and no sinking fund is provided for the Convertible Notes.
As of March 31, 2017,
the Company was compliant with all covenants and conditions under the Convertible Notes.
The Convertible Notes
are subject to the fair value disclosure requirements as discussed in note 5 and are classified as a Level 2 instrument. The estimated
fair value of the Convertible Notes at March 31, 2017 and December 31, 2016 was $297.0 million and $319.5 million, respectively.
13. Commitments
and Contingencies
Operating Leases
The Company leases
office space in the United States, Switzerland and Japan under operating leases through 2027. Total future minimum, non-cancelable
lease payments under operating leases are as follows:
(In thousands)
|
|
March 31,
2017
|
2017
|
|
$
|
1,518
|
|
2018
|
|
|
1,765
|
|
2019
|
|
|
1,518
|
|
2020
|
|
|
1,104
|
|
2021
|
|
|
997
|
|
Total minimum lease payments
|
|
$
|
6,902
|
|
Rent expense for all
operating leases was approximately $430,000 and $645,000 for the three months ended March 31, 2017 and March 31, 2016, respectively.
CPP
Under the terms of
the CPP Securities Agreement, the Company provided $5.0 million to CPP in exchange for a convertible note. The convertible note
is automatically convertible into securities of CPP, subject to certain limitations, in the event CPP consummates a future financing
with aggregate proceeds of at least $10.0 million, exclusive of any investment by the Company, whether through a public offering
or a private offering (a “Qualified Financing”). The Company has agreed to purchase up to $5.0 million of CPP’s
securities in any such Qualified Financing.
14. Stock
Option Plans
A summary of employee
stock option activity for the three months ended March 31, 2017 under the Company’s Amended and Restated 2006 Stock Incentive
Plan is presented below:
2006 Stock Incentive Plan
|
|
Shares
|
|
Weighted
Average
Exercise Price
Per Share
|
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
|
Aggregate
Intrinsic Value
|
Options outstanding, December 31, 2016
|
|
|
4,648,549
|
|
|
$
|
10.86
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Options exercised
|
|
|
(41,472
|
)
|
|
$
|
5.80
|
|
|
|
|
|
|
|
|
|
Options forfeited
|
|
|
(83,775
|
)
|
|
$
|
14.10
|
|
|
|
|
|
|
|
|
|
Options expired
|
|
|
(12,599
|
)
|
|
$
|
9.60
|
|
|
|
|
|
|
|
|
|
Options outstanding, March 31, 2017
|
|
|
4,510,703
|
|
|
$
|
10.85
|
|
|
|
7.8
|
|
|
$
|
8,353,703
|
|
Options exercisable, March 31, 2017
|
|
|
2,310,152
|
|
|
$
|
9.88
|
|
|
|
7.3
|
|
|
$
|
5,687,067
|
|
Options vested and expected to vest, March 31, 2017
|
|
|
4,510,703
|
|
|
$
|
10.85
|
|
|
|
7.8
|
|
|
$
|
8,353,703
|
|
A summary of employee
stock option activity for the three months ended March 31, 2017 under the Company’s 2016 Equity Incentive Plan (the “2016
Plan”) is presented below:
2016 Equity Incentive Plan
|
|
Shares
|
|
Weighted
Average
Exercise Price
Per Share
|
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
|
Aggregate
Intrinsic
Value
|
Options outstanding, December 31, 2016
|
|
|
74,750
|
|
|
$
|
12.66
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
1,244,419
|
|
|
$
|
11.78
|
|
|
|
|
|
|
|
|
|
Options exercised
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Options expired
|
|
|
(36,700
|
)
|
|
$
|
13.97
|
|
|
|
|
|
|
|
|
|
Options outstanding, March 31, 2017
|
|
|
1,282,469
|
|
|
$
|
11.77
|
|
|
|
9.4
|
|
|
$
|
30,080
|
|
Options exercisable, March 31, 2017
|
|
|
78,750
|
|
|
$
|
14.34
|
|
|
|
0.6
|
|
|
$
|
0
|
|
Options vested and expected to vest, March 31, 2017
|
|
|
1,282,469
|
|
|
$
|
11.77
|
|
|
|
9.4
|
|
|
$
|
30,080
|
|
The weighted average
grant date fair value of options granted during the three months ended March 31, 2017 was $6.09.
A summary of employee
restricted stock units activity for the three months ended March 31, 2017 under the Company’s 2016 Plan is presented below:
2016 Equity Incentive Plan
|
|
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
Outstanding Restricted Stock Units, December 31, 2016
|
|
|
63,700
|
|
|
$
|
12.29
|
|
Restricted Stock Units granted
|
|
|
461,804
|
|
|
$
|
11.85
|
|
Restricted Stock Units vested
|
|
|
-
|
|
|
|
-
|
|
Restricted Stock Units forfeited
|
|
|
-
|
|
|
|
-
|
|
Outstanding Restricted Stock Units, March 31, 2017
|
|
|
525,504
|
|
|
$
|
11.90
|
|
Employee Stock Purchase Plan
The following table
summarizes the Company’s 2006 Employee Stock Purchase Plan activity for the three months ended March 31, 2017 and 2016:
|
|
Three Months Ended March 31,
|
(In thousands, except share amounts)
|
|
2017
|
|
2016
|
Shares issued under the ESPP
|
|
|
7,338
|
|
|
|
6,285
|
|
Cash received under the ESPP
|
|
$
|
68,610
|
|
|
$
|
58,391
|
|
Accumulated Other Comprehensive Income
The following table
details the accumulated other comprehensive income (loss) activity for the three months ended March 31, 2017 and 2016:
(In thousands)
|
|
Foreign currency
translation
adjustments
|
|
Unrealized
income on
investments, net
of tax effect
|
|
Unrealized gain
(loss) on pension
benefit obligation
|
|
Accumulated other
comprehensive
income
|
Balance January 1, 2016
|
|
$
|
14,243
|
|
|
$
|
42
|
|
|
$
|
(873
|
)
|
|
$
|
13,412
|
|
Other comprehensive income (loss) before reclassifications
|
|
|
15,555
|
|
|
|
-
|
|
|
|
(8
|
)
|
|
|
15,547
|
|
Amounts reclassified from accumulated other comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Balance March 31, 2016
|
|
$
|
29,798
|
|
|
$
|
42
|
|
|
$
|
(881
|
)
|
|
$
|
28,959
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance January 1, 2017
|
|
$
|
55,119
|
|
|
$
|
42
|
|
|
$
|
(634
|
)
|
|
$
|
54,527
|
|
Other comprehensive income (loss) before reclassifications
|
|
|
(77
|
)
|
|
|
-
|
|
|
|
1
|
|
|
|
(76
|
)
|
Amounts reclassified from accumulated other comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Balance March 31, 2017
|
|
$
|
55,042
|
|
|
$
|
42
|
|
|
$
|
(633
|
)
|
|
$
|
54,451
|
|
15. Income Taxes
The provision for
income taxes is based upon the estimated annual effective tax rates for the year applied to the current period income before tax
plus the tax effect of any significant unusual items, discrete events or changes in tax law. Our operating subsidiaries are exposed
to effective tax rates ranging from zero to approximately 40%. Fluctuations in the distribution of pre-tax income among our operating
subsidiaries can lead to fluctuations of the effective tax rate in the condensed consolidated financial statements. In the three-month
periods ended March 31, 2017 and 2016, the actual effective tax rates were 43.7% and 42.8%, respectively.
We assess uncertain
tax positions in accordance with ASC 740 (ASC 740-10 Accounting for Uncertainties in Tax). As of March 31, 2017, our net unrecognized
tax benefits totaled $3.2 million. Of this balance $1.7 million would favorably impact our effective tax rate in the periods if
they are recognized. Management has not identified any material uncertain tax positions that are reasonably likely to be released
during the next 12 months due to lapse of statutes of limitations or settlements with tax authorities.
We conduct business
globally and, as a result, file numerous consolidated and separate income tax returns in the U.S., Switzerland and Japan, as well
as in various other state and foreign jurisdictions. In the normal course of business, we are subject to examination by taxing
authorities throughout the world. Currently tax years 2012 to 2016 remain open and subject to examination in the major tax jurisdictions
in which tax returns are filed. The tax years 2009-2011 were examined by the U.S. tax authorities and resulted in no tax adjustments.
16. Subsequent
Event
On March
31, 2017, the Company entered into a merger agreement with Vtesse Inc., and on April 3, 2017, acquired Vtesse Inc. for upfront
consideration of $200.0 million. The acquisition was funded through the issuance of 2,782,676 shares of Sucampo Class A common
stock and $170.0 million of cash on hand. Substantially all of the fair value of Vtesse Inc. is related to VTS-270, its only significant
asset. VTS-270 is an investigational drug in a pivotal Phase 2b/3 study for the treatment of NPC-1, an ultra-orphan, progressive
and fatal disease. The Company expects to account for the transaction as an asset acquisition and expects to incur an acquired
in-process research and development charge of $180.0 million to $200.0 million (and no related current tax benefit) in the second
quarter of 2017.
Item 2.
Management’s Discussion
and Analysis of Financial Condition and Results of Operations.
This Quarterly
Report on Form 10-Q contains forward-looking statements regarding Sucampo Pharmaceuticals, Inc. and our business, financial condition,
results of operations and prospects within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include those that express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise
are not statements of historical fact. These forward-looking statements are based on our current expectations and projections about
future events and they are subject to risks and uncertainties, known and unknown, that could cause actual results and developments
to differ materially from those expressed or implied in such statements. Factors that could cause or contribute to such differences
include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included
in our other filings with the Securities and Exchange Commission (SEC) including our Annual Report on Form 10-K for the fiscal
year ended December 31, 2016, which we filed with the SEC on March 8, 2017. Statements made herein are as of the date of the filing
of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable
law, we do not undertake, and we specifically disclaim any obligation to update any forward-looking statements to reflect occurrences,
developments, unanticipated events or circumstances after the date of such statement.
The following discussion
and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated
financial statements and related notes that appear in Item 1 of this Form 10-Q and with our consolidated financial statements and
related notes for the year ended December 31, 2016 which are included in our Annual Report on Form 10-K.
Overview
We are a global biopharmaceutical
company focused on innovative research and development of proprietary drugs to treat gastrointestinal, ophthalmic, autoimmune,
inflammatory, neurological and oncology disorders.
We currently generate
revenue mainly from product royalties, development milestone payments, product sales and reimbursements for clinical development
activities. We expect to continue to incur significant expenses for the next several years as we continue our research and development
activities, seek additional regulatory approvals and additional indications for our approved products and other compounds and seek
strategic opportunities for acquiring new products and product candidates.
Our operations are
conducted through subsidiaries based in the United States (U.S.), Japan and Switzerland. We operate as one segment, which focuses
on the development and commercialization of pharmaceutical products.
AMITIZA (lubiprostone)
United States
and Canada
AMITIZA is marketed
in the U.S. for three gastrointestinal indications under a collaboration and license agreement (North America Takeda Agreement)
with Takeda Pharmaceutical Company Limited (Takeda). These indications are chronic idiopathic constipation (CIC) in adults, irritable
bowel syndrome with constipation (IBS-C) in adult women and opioid-induced constipation (OIC) in adults suffering from chronic
non-cancer related pain. Under the North America Takeda Agreement, we are primarily responsible for clinical development activities,
while Takeda is responsible for commercialization of AMITIZA in the U.S. and Canada. Takeda is required to provide a minimum annual
commercial investment during the current term of the North America Takeda Agreement and may reduce the minimum annual commercial
investment when a generic equivalent enters the market. In October 2015, Health Canada approved AMITIZA for CIC in adults. In October
2014, we signed an amendment (Takeda Amendment) to the North America Takeda Agreement which, among other things, extended the term
of the North American Takeda Agreement beyond December 2020. During the extended term beginning in January 2021, we will share
with Takeda the net sales revenue on branded AMITIZA sales.
We have also partnered
with Par Pharmaceuticals, Inc., or Par, and Dr. Reddy’s Laboratories, Ltd., or Dr. Reddy’s, in connection with the
settlement of patent litigation in the United States related to our AMITIZA 8 mcg and 24 mcg soft gelatin capsule products. Under
our agreement with Par, we granted Par a non-exclusive license to market Par’s generic version of lubiprostone 8 mcg and
24 mcg soft gelatin capsules in the United States for the indications approved for AMITIZA beginning January 1, 2021, or earlier
under certain circumstances. Beginning on January 1, 2021, Par will split with us the gross profits of the licensed products sold
during the term of the agreement, which continues until each of our related patents has expired. Under our agreement with Dr. Reddy’s,
we granted Dr. Reddy’s a non-exclusive license to market Dr. Reddy’s generic version of lubiprostone 8 mcg and 24 mcg
soft gelatin capsules in the United States for the indications approved for AMITIZA. This license does not begin until more than
six years from November 9, 2016, or earlier under certain circumstances. Dr. Reddy’s will pay to us a share of net profits
of generic lubiprostone products sold during the term of the agreement, which decreases over time and ends when all of our related
patents have expired. In the event that either Par or Dr. Reddy’s elect to launch an authorized generic form of lubiprostone,
we have agreed to supply such product under the terms of a manufacturing and supply agreement at a negotiated price.
Japan
In Japan, AMITIZA
is the only prescription medicine for chronic constipation, excluding constipation caused by organic diseases, and is marketed
under a license, commercialization and supply agreement (Japan Mylan Agreement) originally entered into with Abbott Laboratories,
Inc. (Abbott). In February 2015, Mylan purchased Abbott’s non-U.S. developed markets specialty and branded generics business,
as a result of which Mylan acquired the rights to commercialize AMITIZA in Japan. We did not experience any significant changes
in the commercialization of AMITIZA in Japan as a result of the transfer of the Japan Mylan Agreement from Abbott to Mylan.
People’s
Republic of China
In May 2015, we entered
into an exclusive license, development, commercialization and supply agreement (China Gloria Agreement) with Harbin Gloria Pharmaceuticals
Co., Ltd. (Gloria) for AMITIZA in the People’s Republic of China. We will be the exclusive supplier of AMITIZA to Gloria
at an agreed upon supply price. Under the China Gloria Agreement, Gloria is responsible for all development activities and costs,
as well as commercialization and regulatory activities, for AMITIZA in the People’s Republic of China. Upon entering into
the China Gloria Agreement, we received an upfront payment of $1.0 million. In June 2015, the China Food and Drug Administration
accepted an Investigational New Drug (IND) application for a pivotal trial of AMITIZA in patients with CIC, as a result of which
we received an additional payment of $500,000 from Gloria. In addition to the $1.5 million in payments received and recognized
as revenue through June 2015, we are eligible to receive an additional payment in the amount of $1.5 million upon the occurrence
of a specified regulatory or commercial milestone event.
Other Global
Markets
In October 2014, we
entered into an exclusive license, development, commercialization and supply agreement (Global Takeda Agreement) for lubiprostone
with Takeda. Under the Global Takeda Agreement, Takeda develops and markets AMITIZA globally except in the U.S., Canada, Japan
and the People’s Republic of China. We supply Takeda with the clinical and commercial product at a negotiated price. Takeda
currently markets AMITIZA for CIC and OIC in Switzerland, and for CIC in the U.K.
In January 2016, we
received notification from the Medicines and Healthcare Products Regulatory Agency of the United Kingdom (U.K.) that our appeal
for the OIC indication was not approved. In January 2015, we successfully completed the European mutual recognition procedure for
AMITIZA for the treatment of CIC in Austria, Belgium, Germany, Italy, Ireland, Luxembourg, Netherlands and Spain, resulting marketing
authorizations in these markets. Takeda became the marketing authorization holder in Switzerland in April 2015, in the United Kingdom,
Austria, Belgium, Germany, Netherlands, Ireland, Italy, Luxembourg and Spain during 2016.
In October 2015, Takeda
obtained approval of the clinical trial application (CTA) for AMITIZA for the treatment of CIC and IBS-C in Russia that was submitted
in June 2015. In December 2015, a CTA was filed for AMITIZA for the treatment of CIC, IBS-C and OIC in Mexico and South Korea.
Takeda initiated Phase 3 registration trials in Russia in March 2016 and in South Korea and Mexico in May 2016. A new drug application
(NDA) for the treatment of CIC, IBS-C, and OIC was submitted in Israel in June 2015, and approved in July 2016, and in Kazakhstan
in December 2015. Additional NDA submissions have been made by Takeda in Singapore in May 2016, and South Africa and Indonesia
in June 2016, and are planned in various other markets for 2017 and beyond.
RESCULA (unoprostone isopropyl)
As part of the acquisition
of R-Tech Ueno, Ltd. (R-Tech) in October 2015, we acquired global rights to RESCULA, an ophthalmology product used to lower intraocular
pressure (IOP).
In the fourth quarter
of 2014 we ceased marketing RESCULA in the United States and no product was made available after the March 2015 expiration date.
In May 2015, we returned all licenses for unoprostone isopropyl to R-Tech. In June 2016, we completed the withdrawal of the marketing
authorization for RESCULA in the U.S.
In Japan, RESCULA
was approved by the MHLW in 1994 for the treatment of glaucoma and ocular hypertension. In Japan, RESCULA is no longer protected
by regulatory or intellectual property exclusivity. In March 2012, R-Tech signed a distribution agreement (Japan Santen Agreement)
with Santen Pharmaceutical Co., Ltd. (Santen) to commercialize RESCULA in Japan. As part of the acquisition of R-Tech in 2015,
we acquired R-Tech’s rights and obligations under the Japan Santen Agreement.
In Taiwan, R-Tech
signed a manufacturing and supply agreement with Sinphar Pharmaceutical, Co., Ltd. and also executed the distribution agreement
with Zuellig Pharma, Inc. in April 2013.
In February 2017, the
import license for RESCULA in South Korea was withdrawn by Dong-A ST Co., Ltd., our local distributor.
Product Pipeline
The table below summarizes
the development status of our marketed products and key product candidates. The commercialization rights to lubiprostone have been
licensed to Takeda on a global basis other than Japan and the People’s Republic of China, to Mylan for Japan, and to Gloria
for the People’s Republic of China. Commercialization of each product candidate may occur after successful completion of
clinical trials and approval from competent regulatory agencies. For CPP-1X/sulindac, we have an option to acquire an exclusive
license to commercialize in North America.
|
Country
|
Program Type
|
Target Indication
|
Development Phase
|
Next Milestone
|
Lubiprostone (AMITIZA ®)
|
|
|
|
U.S.
|
Commercial
|
Chronic idiopathic constipation (CIC) adults of all ages
|
Marketed
|
_____
|
|
U.S.
|
Commercial
|
Irritable bowel syndrome with constipation (adult women) (IBS-C)
|
Marketed
|
Initiate Phase 4 study on higher dosage and with additional male subjects
|
|
U.S.
|
Commercial
|
Opioid-induced constipation (OIC) in patients with chronic non-cancer pain
|
Marketed
|
_____
|
|
U.S.
|
Clinical
|
Alternate (Sprinkle) formulation - adults of all ages
|
In development
|
Complete Phase 3 trial
|
|
U.S.
|
Clinical
|
Pediatric functional constipation
(6 months - 6 years)
|
Alternate (Sprinkle) formulation in development
|
Initiate Phase 3 program
|
|
U.S.
|
Clinical
|
Pediatric IBS-C
(6 years - 17 years)
|
Alternate (Sprinkle) formulation in development
|
Initiate Phase 3 program
|
|
U.S. &
European Union
|
Clinical
|
Pediatric functional constipation
(6 years - 17 years)
|
Open label Phase 3 trials ongoing
|
Complete open label Phase 3 trial and submit sNDA
|
|
Japan
|
Commercial
|
Chronic constipation
|
Marketed
|
_____
|
|
Japan
|
Clinical
|
CIC adults, 2x12mcg capsule
|
CTN submitted
|
Submit sNDA
|
|
Switzerland
|
Commercial
|
CIC-adults of all ages
|
Marketed
|
_____
|
|
Switzerland
|
Commercial
|
OIC in patients with chronic non-cancer pain
|
Marketed
|
_____
|
|
U.K.
|
Commercial
|
CIC-adults of all ages
|
Marketed
|
_____
|
|
Canada
|
Clinical
|
CIC-adults of all ages
|
Received approval from Health Canada
|
Market in Canada
|
|
China
|
Clinical
|
CIC-adults of all ages
|
IND accepted
|
Initiate CIC study
|
|
European Union
|
Clinical
|
CIC-adults of all ages
|
Received national marketing approvals in Ireland, Germany, Austria, Belgium, the Netherlands, Luxembourg, Italy and Spain (where product is not yet launched)
|
Launch feasibility and planning under evaluation
|
|
Israel
|
Commercial
|
CIC-adults of all ages
|
Approved
|
Develop pricing and reimbursement assessments and, based on outcome, determine launch feasibility and plans
|
|
Mexico
|
Clinical
|
CIC-adults of all ages
|
CTA Approved
|
Complete Phase 3 trial
|
|
Mexico
|
Clinical
|
IBS-C - adult women
|
CTA Approved
|
Complete Phase 3 trial
|
|
Mexico
|
Clinical
|
OIC in patients with chronic non-cancer pain
|
CTA Approved
|
Complete Phase 3 trial
|
|
Russia
|
Clinical
|
CIC-adults of all ages
|
Phase 3 completed
|
MAA submission
|
|
Russia
|
Clinical
|
IBS-C - adult women
|
Phase 3 completed
|
MAA submission
|
|
South Korea
|
Clinical
|
CIC-adults of all ages
|
CTA Approved
|
Complete Phase 3 trial
|
|
South Korea
|
Clinical
|
IBS-C - adult women
|
CTA Approved
|
Complete Phase 3 trial
|
|
South Korea
|
Clinical
|
OIC in patients with chronic non-cancer pain
|
CTA Approved
|
Complete Phase 3 trial
|
|
Country
|
Program Type
|
Target Indication
|
Development Phase
|
Next Milestone
|
Unoprostone isopropyl (RESCULA®)
|
|
|
|
Japan
Taiwan
|
Commercial
|
Glaucoma and ocular hypertension
|
Marketed
|
_____
|
CPP-1X/sulindac combination product
|
|
|
|
U.S.
|
Option
|
Familial adenomatous polyposis (FAP) - adults of all ages
|
Phase 3
|
Complete Phase 3 trial
|
VTS-270 for Niemann-Pick disease type C1 product
|
|
|
|
U.S.
|
Clinical
|
Niemann-Pick disease type C1
|
Phase 2b/3
|
Complete Phase 2b/3 trial
|
Our Clinical Development Programs
Lubiprostone
Alternate Formulation
We are developing
an alternate formulation of lubiprostone for both adult and pediatric patients who are unable to take or do not tolerate capsules
and for naso-gastric tube fed patients. Takeda has agreed to fund 100% of the costs, up to a cap, of this alternate formulation
work. We initiated the Phase 3 program of the alternate formulation of lubiprostone in adults in the second half of 2016 and, if
the program is successful, we intend to file an NDA in the United States for the alternate formulation for adults in the second
half of 2017.
Pediatric Functional
Constipation
The Phase 3 program
required to support an application for marketing authorization of lubiprostone for pediatric functional constipation comprises
four clinical trials. The first two trials, one of which was recently completed, test the soft gelatin capsule formulation of lubiprostone
in patients 6 to 17 years of age. The first of these trials was a pivotal 12-week, randomized, placebo-controlled trial which was
initiated in December 2013 and completed enrollment in April 2016. The second trial is a follow-on, long-term safety extension
trial that was initiated in March 2014. In November 2016, we announced that the Phase 3 trial of AMITIZA in pediatric functional
constipation in children 6 to 17 years of age failed to achieve its primary endpoint of overall spontaneous bowel movement, or
SBM, response. The trial achieved statistical significance for some secondary endpoints, notably overall SBM frequency, straining,
and stool consistency. In addition, in this study lubiprostone was well tolerated. We have entered into a process with the U.S.
Food and Drug Administration, or FDA, and other constituencies, and as a result of initial discussion with the FDA plan to submit
an sNDA in the second half of 2017. Additionally, after further consultations with the FDA to better determine the doses and endpoints
that should be studied, following the Phase 3 program for the alternate formulation of lubiprostone described above, we plan to
initiate in mid-2018 a Phase 3 program in patients 6 months to 6 years of age using the alternate formulation. Takeda has agreed
to fund 70% of the costs, up to a cap, of this pediatric functional constipation program.
CPP 1-X/Sulindac Combination Product
In
January 2016,
we entered into an option and collaboration agreement under which Cancer Prevention Pharmaceuticals, Inc.
(CPP) has granted us the sole option to acquire an exclusive license to commercialize CPP-1X/sulindac combination product in North
America.
This product is currently in a Phase 3 clinical trial, conducted by CPP for the treatment
of familial adenomatous polyposis (FAP). Under our agreement with CPP, we have the exclusive option to license this product for
North America. There are currently no approved treatments for FAP. The ongoing Phase 3 study is a 150-patient, three-arm,
double-blind, randomized trial of the combination agent and the single agent comparators.
Enrollment in the study
has completed and the results from a Phase 3 futility analysis are expected to be available mid-2017. Results from the clinical trial are expected at the end of 2018.
VTS-270 for Niemann-Pick Disease Type
C1 (NPC-1)
On
March 31, 2017, we entered into an Agreement and Plan of Merger with Vtesse Inc. (“Vtesse”) a privately-held rare disease
company. Following the closing of this acquisition on April 3, 2017, we gained Vtesse’s lead product candidate, known as
VTS-270. VTS-270 is a well-characterized mixture of 2-hydroxypropyl-ß-cyclodextrins (HPßCD) with a specific compositional
fingerprint that distinguishes it from other HPßCD mixtures. It is administered by an intrathecal infusion to directly address
the neurological manifestations of disease. Preclinical and early clinical studies suggest that the administration of VTS-270 may
slow or stop certain indicators of NPC-1, an ultra-orphan, progressive and fatal disease caused by a defect in lipid transport
within the cell. VTS-270, which is currently in a fully-enrolled pivotal Phase 2b/3 trial, has been granted breakthrough therapy
designation in the United States and orphan designation in both the United States and EU. Effective treatment of NPC-1 remains
a high unmet need, with no approved products for patients in the United States. Results from the pivotal trial are expected in
mid-2018.
Non-GAAP Financial Metrics
In addition to disclosing
financial results that are determined in accordance with GAAP, we also use the following non-GAAP financial metrics to understand
and evaluate our operating performance:
|
·
|
Adjusted net income, which is GAAP net income (loss) adjusted to exclude the tax-effected impact
of (i) amortization of acquired intangibles and patents, (ii) inventory step-up adjustment, (iii) impairment of in-process research
and development, (iv) restructuring costs, (v) legal settlement, (vi) acquisition related expenses, (vii) amortization of debt
financing costs, (viii) loss on debt extinguishment, (ix) research and development license option expense, (x) acceleration of
deferred revenue, (xi) foreign currency translation, and (xii) one-time severance payments;
|
|
·
|
Adjusted EPS-diluted, which is adjusted net income as defined above expressed on a diluted per
share basis;
|
|
·
|
EBITDA, which is GAAP net income adjusted to exclude (i) taxes, (ii) interest expense, (iii) interest
income, (iv) depreciation, (v) impairment of in-process research and development, (vi) amortization of acquired intangibles, and
(vii) inventory step-up adjustment;
|
|
·
|
Adjusted EBITDA, which is EBITDA as defined above further adjusted to exclude (i) share-based compensation
expense, (ii) restructuring costs, (iii) acquisition-related expenses, (iv) loss on debt extinguishment, (v) research and development
license option expense, (vi) legal settlement, (vii) foreign currency translation, (viii) acceleration of deferred revenue, and
(ix) one-time severance payments.
|
We believe that providing
this additional information is useful to the reader to better assess and understand our operating performance, primarily because
management typically monitors the business adjusted for these items in addition to GAAP results. These non-GAAP financial metrics
should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. Our definition
of these non-GAAP metrics may differ from similarly titled metrics used by others. We view these non-GAAP financial metrics as
a means to facilitate our financial and operational decision-making, including evaluation of our historical operating results and
comparison to competitors’ operating results. These non-GAAP financial metrics reflect an additional way of viewing aspects
of our operations that, when viewed with GAAP results may provide a more complete understanding of factors and trends affecting
our business. The determination of the amounts that are excluded from these non-GAAP financial metrics is a matter of management
judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial
metrics exclude the effect of items that will increase or decrease the company’s reported results of operations, we strongly
encourage investors to review our consolidated financial statements and periodic reports in their entirety.
The following tables
present reconciliations of these non-GAAP financial metrics to the most directly comparable GAAP financial measure for the three
months ended March 31, 2017 and 2016.
|
|
Three Months Ended March 31,
|
(In thousands, except per share amounts)
|
|
2017
|
|
2016
|
Non-GAAP adjusted net income
|
|
|
|
|
|
|
|
|
GAAP net income (loss)
|
|
$
|
4,624
|
|
|
$
|
(4,057
|
)
|
Amortization of acquired intangibles
|
|
|
6,748
|
|
|
|
5,906
|
|
Amortization of patents
|
|
|
5
|
|
|
|
5
|
|
Amortization of inventory step-up adjustment
|
|
|
-
|
|
|
|
8,932
|
|
Research and development license expense
|
|
|
-
|
|
|
|
3,000
|
|
Restructuring costs
|
|
|
365
|
|
|
|
183
|
|
One-time severance payments
|
|
|
476
|
|
|
|
-
|
|
Acquisition related expenses
|
|
|
7,010
|
|
|
|
527
|
|
Amortization of debt financing costs
|
|
|
472
|
|
|
|
922
|
|
Foreign currency translation
|
|
|
(194
|
)
|
|
|
351
|
|
Tax effect of adjustments
|
|
|
(6,528
|
)
|
|
|
(6,019
|
)
|
Non-GAAP adjusted net income
|
|
$
|
12,978
|
|
|
$
|
9,750
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjusted EPS - diluted
|
|
$
|
0.23
|
|
|
$
|
0.23
|
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
Non-GAAP EBITDA
|
|
|
|
|
|
|
|
|
GAAP net income (loss)
|
|
$
|
4,624
|
|
|
$
|
(4,057
|
)
|
Taxes
|
|
|
3,585
|
|
|
|
(3,038
|
)
|
Interest expense
|
|
|
2,890
|
|
|
|
6,270
|
|
Interest income
|
|
|
(28
|
)
|
|
|
(25
|
)
|
Depreciation and amortization
|
|
|
198
|
|
|
|
259
|
|
Impairment of in-process research and development
|
|
|
|
|
|
|
|
|
Amortization of acquired intangibles
|
|
|
6,753
|
|
|
|
5,911
|
|
Amortization of inventory step-up adjustment
|
|
|
-
|
|
|
|
8,932
|
|
EBITDA
|
|
$
|
18,022
|
|
|
$
|
14,252
|
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
Non-GAAP adjusted EBITDA
|
|
|
|
|
|
|
|
|
EBITDA
|
|
$
|
18,022
|
|
|
$
|
14,252
|
|
Share-based compensation expense
|
|
|
2,275
|
|
|
|
1,915
|
|
Research and development license expense
|
|
|
-
|
|
|
|
3,000
|
|
Restructuring costs
|
|
|
365
|
|
|
|
183
|
|
One-time severance payments
|
|
|
476
|
|
|
|
-
|
|
Acquisition related expenses
|
|
|
7,010
|
|
|
|
527
|
|
Foreign currency translation
|
|
|
(194
|
)
|
|
|
351
|
|
Adjusted EBITDA
|
|
$
|
27,954
|
|
|
$
|
20,228
|
|
Results of Operations
Revenues
The following table
summarizes our revenues for the three months ended March 31, 2017 and 2016:
|
|
Three Months Ended
March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Product royalty revenue
|
|
$
|
18,435
|
|
|
$
|
16,716
|
|
Product sales revenue - AMITIZA
|
|
|
31,340
|
|
|
|
23,434
|
|
Product sales revenue - RESCULA
|
|
|
2,814
|
|
|
|
3,161
|
|
Research and development revenue
|
|
|
3,448
|
|
|
|
3,430
|
|
Contract and collaboration revenue
|
|
|
246
|
|
|
|
467
|
|
Total
|
|
$
|
56,283
|
|
|
$
|
47,208
|
|
Total revenues were
$56.3 million for the three months ended March 31, 2017, compared to $47.2 million for the three months ended March 31, 2016, an
increase of $9.1 million or 19.2%.
Product royalty
revenue
Product royalty revenue
primarily represents royalty revenue earned on Takeda net sales of AMITIZA in North America and was $18.4 million for the three
months ended March 31, 2017 compared to $16.7 million for the three months ended March 31, 2016, an increase of $1.7 or 10.3%.
The increase was primarily due to higher Takeda reported AMITIZA net sales which were driven by a mix of price and volume increases.
Product sales
revenue
Product sales revenue
represents drug product sales of AMITIZA in North America, Japan and Europe, and drug product sales of RESCULA in Japan. AMITIZA
product sales revenue was $31.3 million for the three months ended March 31, 2017 compared to $23.4 million for the three months
ended March 31, 2015, an increase of $7.9 million or 33.7%. The increase was primarily attributable to increased AMITIZA sales
in Japan under the Japan Mylan Agreement. RESCULA product sales revenue was $2.8 million for the three months ended March 31, 2017
compared to $3.2 million for the three months ended March 31, 2016, a decrease of $347,000.
Research and
development revenue
Research and development
revenue was $3.4 million for the three months ended March 31, 2017 compared to $3.4 million for the three months ended March 31,
2016. The amounts remain reasonably consistent year over year due to the advancement of the pediatric and alternative formulation
studies.
Contract and
collaboration revenue
Contract and collaboration
revenue was $246,000 for the three months ended March 31, 2017 compared to $467,000 for the three months ended March 31, 2016,
a decrease of $221,000 or 47.3%. The decrease was primarily due to the higher release of the collaboration obligation under the
Global Takeda Agreement in the first quarter 2016.
Costs of Goods Sold
Costs of goods
sold were $16.9 million for the three months ended March 31, 2017 compared to $23.3 million for the three months ended March 31,
2016, a decrease of $6.5 million or 27.7%. The decrease was primarily due to an $8.9 million decrease in amortization of R-Tech
inventory step up, partially offset by increased costs of goods sold related to increased AMITIZA product sales.
Research and Development Expenses
The following table
summarizes our research and development expenses for the three months ended March 31, 2017 and 2016:
|
|
Three Months Ended
|
|
|
March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Direct costs:
|
|
|
|
|
|
|
|
|
Lubiprostone
|
|
$
|
7,965
|
|
|
$
|
5,626
|
|
Cobiprostone
|
|
|
-
|
|
|
|
2,109
|
|
CPP-1X
|
|
|
-
|
|
|
|
2,989
|
|
RTU-1096
|
|
|
-
|
|
|
|
920
|
|
VAP-1
|
|
|
-
|
|
|
|
29
|
|
Other
|
|
|
1,056
|
|
|
|
1,390
|
|
|
|
|
9,021
|
|
|
|
13,063
|
|
Indirect costs
|
|
|
1,312
|
|
|
|
1,608
|
|
Total
|
|
$
|
10,333
|
|
|
$
|
14,671
|
|
Total research and
development expenses for the three months ended March 31, 2017 were $10.3 million compared to $14.7 million for the three months
ended March 31, 2016, a decrease of $4.3 million or 29.6%. The decrease was primarily due to the discontinuance of cobiprostone
development and non-recurring CPP option costs in 2016.
General and Administrative Expenses
The following table
summarizes our general and administrative expenses for the three months ended March 31, 2017 and 2016:
|
|
Three Months Ended
|
|
|
March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Salaries, benefits and related costs
|
|
$
|
3,694
|
|
|
$
|
2,847
|
|
Legal, consulting and other professional expenses
|
|
|
9,746
|
|
|
|
2,070
|
|
Stock-based compensation
|
|
|
1,608
|
|
|
|
1,278
|
|
Pharmacovigilance
|
|
|
160
|
|
|
|
428
|
|
Other expenses
|
|
|
2,483
|
|
|
|
2,304
|
|
Total
|
|
$
|
17,691
|
|
|
$
|
8,927
|
|
General and administrative
expenses were $17.7 million for the three months ended March 31, 2017, compared to $8.9 million for the three months ended March
31, 2016, an increase of $8.8 million or 98.2%. The increase was primarily due to a $7.7 million increase in legal, consulting
and other professional expenses related to acquisition activities. The Company recorded restructuring charges of $365,000 and $183,000
for the three months ended March 31, 2017 and 2016, respectively. These costs are reflected within other expenses and consisted
primarily of termination benefits.
Selling and Marketing Expenses
The following table
summarizes our selling and marketing expenses for the three months ended March 31, 2017 and 2016:
|
|
Three Months Ended
|
|
|
March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Salaries, benefits and related costs
|
|
$
|
239
|
|
|
$
|
227
|
|
Consulting and other professional expenses
|
|
|
70
|
|
|
|
35
|
|
Data purchases
|
|
|
40
|
|
|
|
46
|
|
Promotional materials & programs
|
|
|
67
|
|
|
|
1
|
|
Other expenses
|
|
|
100
|
|
|
|
466
|
|
Total
|
|
$
|
516
|
|
|
$
|
775
|
|
Non-Operating Income and Expense
The following table
summarizes our non-operating income and expense for the three months ended March 31, 2017 and 2016:
|
|
Three Months Ended
|
|
|
March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Interest income
|
|
$
|
28
|
|
|
$
|
25
|
|
Interest expense
|
|
|
(2,890
|
)
|
|
|
(6,270
|
)
|
Other income (expense), net
|
|
|
211
|
|
|
|
(347
|
)
|
Total
|
|
$
|
(2,651
|
)
|
|
$
|
(6,592
|
)
|
Interest expense was
$2.9 million for the three months ended March 31, 2017, compared to $6.3 million for the three months ended March 31, 2016, a decrease
of $3.4 million or 53.9%. This decrease resulted from interest rates on notes payable decreasing from 8.4% to 3.3% as a result
of refinancing our debt with Convertible Notes. The benefit from the lower interest rates was partially offset by higher principal
balances.
Other income (expense),
net was income of $211,000 for the three months ended March 31, 2017, compared to expense of $347,000 for the three months ended
March 31, 2016, a change of $558,000, substantially all of which was attributable to increased foreign currency exchange gains.
Income Taxes
We recorded an income
tax expense of $3.6 million and benefit of $3.0 million for the three months ended March 31, 2017 and 2016, respectively. The increase
in the tax provision for the three months ended March 31, 2017 primarily pertained to increased pretax earnings in 2017 as compared
to 2016 as well as foreign taxes paid on foreign exchange gains. The tax provision for the three months ended March 31, 2016 primarily
pertained to pre-tax profits and losses generated by our Japanese and Swiss subsidiaries.
The effective tax
rate (ETR) for the first quarter of 2017 was 43.7%, compared to 42.8% in the same period of 2016. The ETR for the quarter was based
on a projection of the full year rate. The increase in the ETR was primarily due to foreign taxes paid on foreign exchange gains.
Reportable Operating Segments
We have one operating
segment which is the development and commercialization of pharmaceutical products.
Financial Condition, Liquidity and Capital
Resources
Financial Condition
Sources of Liquidity
We finance
our operations principally from cash generated from revenues, cash and cash equivalents on hand, debt and to a lesser extent, from
cash generated from the issuance and sale of our class A common stock and through the exercise of employee stock options. Revenues
generated from operations principally consist of a combination of royalty payments, product sales, upfront and milestone payments,
and research and development expense reimbursements received from Takeda, Mylan and other parties.
Our cash,
cash equivalents and restricted cash consist of the following as of March 31, 2017 and December 31, 2016:
|
|
March 31,
|
|
December 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Cash and cash equivalents
|
|
$
|
243,480
|
|
|
$
|
198,308
|
|
Restricted cash, current
|
|
|
213
|
|
|
|
213
|
|
Total
|
|
$
|
243,693
|
|
|
$
|
198,521
|
|
Our cash and cash
equivalents are deposited in operating accounts and highly liquid investments with an original maturity at time of purchase of
90 days or less. As of March 31, 2017, and December 31, 2016, our restricted cash consisted of a certificate of deposit pledged
to support an operating lease for our former office facility in Bethesda, Maryland.
On March
31, 2017, we entered into a merger agreement with Vtesse Inc., and on April 3, 2017, acquired Vtesse Inc. for upfront consideration
of $200.0 million. The acquisition was funded through the issuance of 2,782,676 shares of Sucampo Class A common stock and $170.0
million of cash on hand. Substantially all of the fair value of Vtesse Inc. is related to VTS-270, its only significant asset.
VTS-270 is an investigational drug in a pivotal Phase 2b/3 study for the treatment of NPC-1, an ultra-orphan, progressive and fatal
disease.
Cash Flows
The following table
summarizes our cash flows for the three months ended March 31, 2017 and 2016:
|
|
Three Months Ended March 31,
|
(In thousands)
|
|
2017
|
|
2016
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$
|
45,280
|
|
|
$
|
23,737
|
|
Investing activities
|
|
|
(350
|
)
|
|
|
(3,350
|
)
|
Financing activities
|
|
|
308
|
|
|
|
917
|
|
Effect of exchange rates
|
|
|
(66
|
)
|
|
|
489
|
|
Net increase in cash and cash equivalents
|
|
$
|
45,172
|
|
|
$
|
21,793
|
|
Three months ended March 31, 2017
Net cash provided
by operating activities was $45.3 million for the three months ended March 31, 2017. This was primarily due to net income of $4.6
million plus adjustments to reconcile net income to net cash provided by operating activities consisting of depreciation and amortization
of $7.4 million, stock-based compensation expense of $2.4 million, less deferred tax provision of $2.9 million, as well as changes
in operating assets and liabilities consisting of a decrease in receivables of $30.3 million, and an increase in payables and accrued
expenses of $5.9 million, partially offset by a change in prepaid and income taxes payable and receivable, net of $3.7 million.
Net cash used in investing
activities was $0.4 million for the three months ended March 31, 2017 due to purchases of property and equipment.
Net cash provided
by financing activities was $0.3 million for the three months ended March 31, 2017. This was realized through the issuance of Class
A common stock upon the exercise of options and purchases through the employee stock purchase plan.
The effect of exchange
rates on the cash balances of currencies held in foreign denominations for three months ended March 31, 2017 was a decrease of
$66,000.
Three months ended March 31, 2016
Net cash provided
by operating activities was $23.7 million for the three months ended March 31, 2016. This was primarily due to depreciation and
amortization of $15.6 million, a decrease in receivables of $13.6 million, an increase in payables and accrued expenses of $3.6
million, offset by a net loss of $4.1 million and a net change in other assets and liabilities of $4.4 million.
Net cash used in investing
activities was $3.4 million for the three months ended March 31, 2016. This was primarily due to the payment of the squeeze-out
liability for non-tendering R-Tech shareholders of $8.2 million and investment in a convertible note receivable of $5.0 million,
offset by a decrease in restricted cash of $10.6 million.
Net cash provided
by financing activities was $0.9 million for the three months ended March 31, 2016. This was primarily realized through the issuance
of Class A common stock upon the exercise of options.
The effect of exchange
rates on the cash balances of currencies held in foreign denominations for three months ended March 31, 2016 was an increase of
$489,000.
Off-Balance Sheet Arrangements
As of March 31, 2017,
we did not have any off-balance sheet arrangements, as such term is defined in Item 303(a)(4) of Regulation S-K under the Securities
Act of 1933, as amended.
Funding Requirements and Capital
Resources
We may need substantial
amounts of capital to continue growing our business. We may require this capital, among other things, to fund:
|
·
|
our share of the on-going development program of AMITIZA;
|
|
·
|
research, development, manufacturing, regulatory and marketing efforts for VTS-270 and other potential
product candidates;
|
|
·
|
the costs involved in obtaining and maintaining proprietary protection for our products, technology
and know-how, including litigation costs and the results of such litigation;
|
|
·
|
activities to resolve our on-going and potential legal matters;
|
|
·
|
any option and milestone payments under general option and licensing ventures, including our exclusive
option and collaboration agreement with CPP;
|
|
·
|
other business development activities, including partnerships, alliances and investments in or
acquisitions of other businesses, products and technologies;
|
|
·
|
the expansion of our commercialization activities including the purchase of inventory; and
|
|
·
|
the payment of principal and interest under our Convertible Notes.
|
The timing of these
funding requirements is difficult to predict due to many factors, including the outcomes of our preclinical and clinical research
and development programs and when those outcomes are determined, the timing of obtaining regulatory approvals and the presence
and status of competing products. Our capital needs may exceed the capital available from our future operations, collaborative
and licensing arrangements and existing liquid assets. Our future capital requirements and liquidity will depend on many factors,
including, but not limited to:
|
·
|
the cost and time involved to pursue our research and development programs;
|
|
·
|
our ability to establish collaborative arrangements and to enter into licensing agreements and
contractual arrangements with others; and
|
|
·
|
any future change in our business strategy.
|
To the extent that
our capital resources may be insufficient to meet our future capital requirements, we may need to finance our future cash needs
through at-the-market sales, public or private equity offerings, further debt financings or corporate collaboration and licensing
arrangements.
At March 31, 2017,
based upon our current business plan, we believe our future cash flows from operating activities and our existing capital resources
will be sufficient to meet our cash requirements for at least the next 12 months.
Effects of Foreign Currency
We currently receive
a portion of our revenue, incur a portion of our operating expenses, and have assets and liabilities denominated in currencies
other than the U.S. Dollar, the reporting currency for our consolidated financial statements. As such, the results of our operations
could be adversely affected by changes in exchange rates either due to transaction losses, which are recognized in the statement
of operations, or translation losses, which are recognized in comprehensive income. We currently do not hedge foreign exchange
rate exposure via derivative instruments.