Sucampo Acquires Vtesse Inc.
(Thomson Reuters ONE) -
Transaction Valued at $200 Million Upfront
Diversifies Pipeline with Late Stage Program in Niemann-Pick Disease Type C1
(NPC-1)
Increases Company Focus on Specialized Diseases with High Unmet Need
Leverages Focus on Orphan and Pediatric Diseases
Expected to be Accretive to Earnings Beginning in 2019
Shareholders and Investors of Sucampo and Vtesse to Establish Foundation to
Support Research Related to NPC Disease
Company to Host Conference Call Today at 8:30 a.m. EDT
ROCKVILLE, Md., and GAITHERSBURG, Md., April 03, 2017 (GLOBE NEWSWIRE) --
Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global
biopharmaceutical company, and Vtesse Inc. (Vtesse), a privately-held rare
disease company, today announced that Sucampo has acquired Vtesse for upfront
consideration of $200 million. Sucampo funded the acquisition through the
issuance of 2,782,678 shares of Sucampo Class A common stock and $170 million of
cash on hand; no external financing was utilized.
Strategic and Financial Benefits of the Transaction
* Acquisition provides Sucampo with VTS-270, which is in a pivotal study for
the treatment of Niemann-Pick Disease Type C1 (NPC-1)
* Builds on Sucampo's capabilities, global development platform and focus on
specialized areas of high, unmet medical need
* Fully-enrolled global pivotal clinical trial, with results expected in mid-
2018
* Sucampo provides capabilities and resources to accelerate the global
development and potential commercialization of VTS-270
* Aligns with Sucampo's patient-focused mission and contributes to goal of
building an increasingly diversified, global biopharmaceutical company
* Product is expected to be launched and accretive to earnings beginning in
2019
* Vtesse team will continue to support the advancement of VTS-270
About Niemann-Pick Disease Type C1
* Rare genetic disorder that begins impacting the lives of those affected from
birth to early adulthood. Clinical symptoms do not slow or reverse, with
complications from neurological manifestations being the primary cause of
eventual fatalities
* Incidence of NPC-1 is estimated between 1:100,000 to 1:150,000 live births
* Estimated 2,000-3,000 cases globally
* NPC-1 results in early death in the vast majority of cases
* Currently no approved treatments for the disease in the U.S.
About 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 pivotal Phase 2b/3 trial, has been granted breakthrough therapy
designation in the U.S. and orphan designation in both the U.S. and EU.
Effective treatment of NPC remains a high unmet need, with no approved products
for patients in the U.S. Results from the pivotal trial are expected in mid-
2018.
"We are extremely pleased to announce the acquisition of Vtesse. Sucampo brings
significant capabilities to Vtesse and its program, and we believe that this
acquisition not only has the potential to make an important difference in the
lives of patients, their families, and the dedicated physicians who care for
them, but also to create value for shareholders. We welcome the employees of
Vtesse to our team and look forward to accelerating the global development of
VTS-270 in the hopes of bringing this novel treatment to patients afflicted by
Niemann-Pick Disease Type C1 in the U.S. and around the globe," said Peter
Greenleaf, Chairman and Chief Executive Officer of Sucampo.
"The Vtesse team remains fully committed to the NPC community and will provide
continuity to the patients, families, and clinical sites in cooperation with
Sucampo. We recognize that Sucampo shares our commitment to the patients and
caregivers of NPC and provides us with the best opportunity to bring this
important treatment to NPC-1 patients in the U.S. and around the globe.
Together, we will accelerate the global development and commercialization of
VTS-270, relying on the complementary capabilities at Sucampo. Our commitment
to the patients, families and physicians remains steadfast," said Ben Machielse,
Drs, President, Founder and Chief Executive Officer of Vtesse Inc.
Since its launch in January 2015, the Vtesse team has fully enrolled the
registrational study of VTS-270 in NPC-1 at 20 clinical trial sites across the
globe, providing broad access for study-eligible patients. The team has also
been developing a device to assist healthcare providers with administration of
VTS-270 to patients, and has supported compassionate use of the drug candidate.
Terms of the Transaction
Sucampo has acquired Vtesse for an upfront consideration of $200 million, and
has agreed to pay Vtesse shareholders contingent consideration based on mid-
single digit to double-digit royalties on global net sales of the product based
on increasing net sales levels, and a share of net proceeds that may be
generated from the monetization of the pediatric review voucher, which is
expected to be granted in connection with the approval of the product in the
U.S. The upfront payment was made in the form of issuance of 2,782,678 Sucampo
Class A common shares to the Vtesse shareholders and the payment of $170 million
(subject to a working capital adjustment) in cash on hand. No external
financing was required for this acquisition. The Vtesse shareholders have
agreed to a three-month lock-up of the common shares that were issued, and
Sucampo has agreed to register the common shares for resale after the lock-up
expires.
Vtesse employees are expected to join Sucampo to continue the important mission
they have embarked upon at Vtesse of bringing an NPC therapy to market.
Additionally, Vtesse and Sucampo intend to establish a foundation after the
closing of the acquisition to support research related to NPC disease. The
establishment of this foundation is a testament to the high level of commitment
the Vtesse and Sucampo teams have to scientific advancement regarding NPC.
Subject to finalizing the terms of the foundation, Vtesse's equity holders have
set aside a portion of the transaction proceeds to contribute to the foundation,
and Sucampo intends to match the Vtesse shareholder contribution from its
corporate funds.
"At the time of Vtesse's launch in January 2015, Vtesse's original investors
recognized the imperative of driving VTS-270 rapidly through clinical
development to secure the data for regulatory approvals and to deliver the drug
candidate to the NPC-1 community. Sucampo is a global partner that is fully
behind the original mission of Vtesse and its investment group. We're very
proud to join their shareholders in establishing a foundation that will support
further research of and awareness-building for NPC disease," said David Mott,
General Partner, NEA, and Vtesse's Board Chair.
Guidance
Sucampo today updated its guidance for the full year ending December 31, 2017,
incorporating the Vtesse acquisition, as follows:
+----------------------------------------------------+
| Previous Revised |
| Guidance Full Year 2017 Full Year 2017 |
| ($'s M) Guidance Guidance |
| except EPS Pre Vtesse Post Vtesse |
| |
| Revenue $220 - $230 $220 - $230 |
| |
| Adj. Net Income $80 - $90 $56 - $66 |
| |
| Adj. EBITDA $145 - $155 $109 - $119 |
| |
| Adj. EPS $1.35 - $1.50 $1.00 - $1.10 |
| |
| Free Cash Flow $106 - $116 $86 - $96 |
+----------------------------------------------------+
Advisors
Jefferies LLC served as financial advisor to Sucampo and Leerink Partners served
as financial advisor to Vtesse; Cooley LLP served as legal advisor to Sucampo,
and Wilmer Cutler Pickering Hale and Dorr LLP served as legal advisor to Vtesse.
Non-GAAP Financial Measures
This press release contains four financial metrics (Adjusted Net Income, EBITDA,
Adjusted EBITA and Free Cash Flow) that are considered "non-GAAP" financial
metrics under applicable Securities and Exchange Commission rules and
regulations. These non-GAAP financial metrics should be considered supplemental
to and not a substitute for financial information prepared in accordance with
generally accepted accounting principles. The company's definition of these non-
GAAP metrics may differ from similarly titled metrics used by others. Adjusted
Net Income adjusts for specified items that can be highly variable or difficult
to predict, and various non-cash items, which includes amortization of acquired
intangibles, inventory step-up adjustment, R&D intangible asset impairment,
restructuring costs, legal settlement, acquisition related expenses,
amortization of debt financing costs, debt extinguishment, R&D license option
expense, acquisition related acceleration of deferred revenue, foreign currency
translations and the tax impact of these adjustments. EBITDA reflects net income
excluding the impact of provision for income taxes, interest expense, interest
income, depreciation, R&D intangible asset impairment, amortization of acquired
intangibles and inventory step-up adjustments. Adjusted EBITDA reflects EBITDA
and adjusts for specified items that can be highly variable or difficult to
predict, and various non-cash items, which includes share based compensation
expense, restructuring costs, acquisition related expenses, debt extinguishment,
R&D license option, legal settlement, foreign currency translations and the
acquisition related acceleration of deferred revenue. Free cash flow reflects
net cash provided by operating activities less expenditures made for property
and equipment. The company views these non-GAAP financial metrics as a means to
facilitate management's financial and operational decision-making, including
evaluation of the company's historical operating results and comparison to
competitors' operating results. These non-GAAP financial metrics reflect an
additional way of viewing aspects of the company's operations that, when viewed
with GAAP results may provide a more complete understanding of factors and
trends affecting the company's 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, management strongly
encourages investors to review the company's consolidated financial statements
and publicly-filed reports in their entirety.
Company to Host Conference Call Today
Sucampo will host a conference call and webcast today, Monday, April 3, 2017 at
8:30 am ET. Conference call and Webcast participation details are as follows:
Dial-in number: 888-636-8238 (domestic) or 484-747-6635 (international)
Passcode: 98372393
Webcast link: http://www.sucampo.com/investors/events-presentations/
Conference call replay:
Dates: Starting at 11:30 AM ET, April 3, 2017 a replay of the teleconference and
webcast will be available
Dial-in number: 855-859-2056 (domestic) or 404-537-3406 (international)
Passcode: 98372393
Webcast link: http://www.sucampo.com/investors/events-presentations/; then click
'Archived Events'
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the development and
commercialization of medicines that meet major unmet medical needs of patients
worldwide. Sucampo has two marketed products - AMITIZA, its lead product, and
RESCULA - and a pipeline of product candidates in clinical development. A global
company, Sucampo is headquartered in Rockville, Maryland, and has operations in
Japan and Switzerland. For more information, please visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are registered
trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.
Follow us on Twitter ((at)Sucampo_Pharma). Follow us on LinkedIn (Sucampo
Pharmaceuticals).
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About Vtesse Inc.
Vtesse Inc. is a rare disease company dedicated to developing drugs for patients
suffering from underserved diseases. Vtesse closely collaborates with the
National Institutes of Health (NIH), parents, patient support groups and other
academic institutions to advance VTS-270 towards regulatory approval. Vtesse is
also progressing earlier stage programs for lysosomal storage diseases,
including next-generation therapeutics for NPC. Vtesse is based in Gaithersburg,
Maryland. For more information, visit www.vtessepharma.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These include
statements about the development and potential commercialization of VTS-270, the
timing of expected clinical trial results, the accretiveness of VTS-270 to
earnings, if approved, and the timing of such accretiveness, the potential
issuance of a pediatric review voucher and updated financial guidance. These
statements are based on management's current expectations and involve risks and
uncertainties, which may cause results to differ materially from those set forth
in the statements. The forward-looking statements may include statements
regarding the development or commercial potential of Sucampo's products, and
other statements that are not historical facts. The following factors, among
others, could cause actual results to differ from those set forth in the
forward-looking statements: the impact of pharmaceutical industry regulation and
health care legislation; Sucampo's ability to accurately predict future market
conditions; Sucampo's ability to successfully integrate the operations of
acquired businesses; dependence on the effectiveness of Sucampo's patents and
other protections for innovative products; the effects of competitive products
on Sucampo's products; and exposure to litigation and/or regulatory actions.
No forward-looking statement can be guaranteed and actual results may differ
materially from those projected. Sucampo undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that affect Sucampo's
business, particularly those mentioned in the risk factors and cautionary
statements in Sucampo's most recent Form 10-K as filed with the Securities and
Exchange Commission on March 8, 2017, as well as its filings with the Securities
and Exchange Commission on Forms 8-K and 10-Q since the filing of the Form 10-K,
all of which Sucampo incorporates by reference.
Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
staylor(at)sucampo.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sucampo Pharmaceuticals, Inc. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 03.04.2017 - 12:30 Uhr
Sprache: Deutsch
News-ID 534027
Anzahl Zeichen: 18465
contact information:
Town:
Bethesda, Maryland
Kategorie:
Business News
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