Commercial launch for Noctiva™ on target for
second quarter 2018
Avadel Pharmaceuticals plc (NASDAQ:AVDL), “Avadel” or “the
Company,” today announced its 2018 corporate objectives and
financial expectations, including the commercial launch of Noctiva™
and the anticipated filing of a New Drug Application (NDA) for both
FT218, a once-nightly formulation of sodium oxybate using
Micropump®, and its fourth Unapproved Marketed Drug (UMD) product,
AV001.
For 2018, the Company has set forth the
following expectations:
- Implement a full-scale commercial launch for Noctiva during the
second quarter
- File the NDA for FT218 by the end of 2018
- File the NDA for AV001, its fourth UMD product
- Maintain market leading position across its portfolio of
hospital products and improve the effectiveness and efficiency of
its pediatric operations
- Enhance portfolio development through selective M&A and
advancement of internal pipeline
- Generate total revenues between $110 - $130 million
Mike Anderson, Avadel’s Chief Executive Officer,
remarked, “We are excited to enter 2018 with a set of strategic
objectives that will be transformational for our company.
Achievement of these objectives moves us towards our goal of
becoming a fully integrated specialty pharmaceutical company with
an exceptional long-term growth trajectory. We have built a strong
base business that has provided and continues to provide us cash
flow, and we have laid the groundwork to invest in our future.”
Mr. Anderson continued, “We not only expect to
successfully complete our Phase III REST-ON trial of FT218 for
excessive daytime sleepiness and cataplexy, and subsequently file
our NDA by year end, but we are also gearing up for a strong
commercial launch for Noctiva™ in the second quarter. Both FT218
and Noctiva are proprietary products with enormous market
potential. They will expand our commercial footprint into new
therapeutic categories and create meaningful long-term value for
shareholders.”
Clinical Operations
Avadel is progressing in enrolling patients for
its REST-ON Phase III clinical trial. REST-ON is a double-blind,
randomized, placebo controlled study of 264 patients to assess the
efficacy and safety of FT218, a once nightly formulation of sodium
oxybate for extended-release oral suspension for the treatment of
excessive daytime sleepiness (EDS) and cataplexy in patients
suffering from narcolepsy. FT218 uses the Company’s proprietary
Micropump® drug delivery technology.
“Filing the NDA for FT218 by the end of 2018 is
still our target, and strategies to drive enrollment through social
media, clinical site incentive goals and identification of
additional clinical sites have aided us in maintaining this
objective. We recognize that enrollment is the most difficult
aspect of this trial given the limited population of narcolepsy
patients and the strict exclusion criteria agreed upon in our
Special Protocol Assessment with FDA. The important thing is that
we continue to make progress with patient enrollment and
simultaneously prepare the nonclinical and CMC requirements for our
NDA filing,” said Mr. Anderson.
Mr. Anderson continued, “We maintain that FT218
is our most important clinical project in 2018. The opportunity to
enter a possible blockbuster market with a potentially superior
product is incredibly meaningful for our company. The current
approved product to treat the condition generates well over $1
billion per year. Based on an independent claims analysis, there
exists a large body of patients who ultimately choose not to remain
on the approved twice-nightly version of sodium oxybate, with only
46% of new start patients persisting on treatment at twelve
months1. The need and desire for a once-nightly product from
the medical community and patients are strong, and we believe FT218
has the potential to meet these needs.”
In addition to FT218, Avadel is also working to
file an NDA for a fourth sterile injectable product, AV001, which
is currently being marketed by another company without FDA
approval. During the formulation and development work for AV001,
the Company uncovered what it believes is a meaningful improvement
to the product’s safety profile. AV001 is expected to compete in an
estimated market size of approximately $30 - $40 million per year
once launched in 2019.
Commercial Operations
Noctiva™
In September 2017, Avadel in-licensed Noctiva,
the first and only FDA approved product for nocturia due to
nocturnal polyuria. Nocturnal polyuria is the overproduction of
urine at night and leads to the condition of nocturia, which causes
patients to wake two or more times per night to void. It is
estimated that nocturia affects approximately 40 million2 people in
the United States and represents a large unaddressed and unmet
medical need.
Greg Divis, Avadel’s Chief Commercial Officer,
said, “We are making great progress in executing our launch plans
for Noctiva. We have completed hiring for all key roles, including
an eighty person salesforce that will be out in the field as soon
as late January to begin disease state education and initiating
patient experience programs across urology specialists. We remain
very pleased with the continued feedback we have received from
physicians, patients and payers as it relates to Noctiva. Overall,
we are confident that the work we have been doing will set us up
for a successful commercial launch in the second quarter.”
The Company estimates that peak revenues for
Noctiva could be as high as $750 million or more per year.
Hospital Products
Avadel’s three sterile injectable products,
Akovaz® (ephedrine sulfate), Bloxiverz® (neostigmine methylsulfate)
and Vazculep® (phenylephrine hydrochloride), ended 2017 as market
share leaders for each of their respective categories. Akovaz and
Bloxiverz were both subject to additional generic competitors late
in the second half of 2017, and the Company expects increased
pressure on both share and price as a result in 2018. Avadel
remains committed to maintaining market leadership across its
hospital products during 2018.
Mr. Divis said, “These hospital products were
developed to provide the company with cash flow and they have
exceeded our expectations. Despite the increasingly competitive
environment for these generics, we have continued to maintain
market leadership and strong gross margins across our portfolio,
and we fully anticipate that these products will continue to be
valuable assets to our company.”
Pediatric Products
Avadel’s pediatric products showed good growth
during 2017 with Karbinal ER showing especially robust
growth. Recent weekly prescription trends for Karbinal ER
average approximately 1,800 TRxs per week, representing greater
than 200% growth over 2016. In July, Flexichamber was
launched and continues to grow slowly but steadily. The
company’s original plan for the pediatric business was to include
additional products to add to those acquired from FSC
Pediatrics. To date, the company continues to look for
proprietary meaningfully differentiated products with growth
potential to add into the portfolio.
2017 Outlook
The Company is reaffirming its 2017 revenue
guidance to be in the range of $165 to $175 million and expects to
be at the top end of its adjusted EPS guidance of $0.25 to
$0.35.
2018 Financial Guidance
Due to the generic nature of its hospital
business and recent increased competition, the Company expects
revenues to decline on a year-over-year basis and anticipates
generating between $110 - $130 million in revenues for 2018,
including $10 - $20 million of Noctiva revenues. In preparation to
reach its 2018 strategic objectives, the Company expects to invest
heavily in both Research & Development (R&D) and Sales
& Marketing. R&D costs are expected to range from $40 - $50
million, the majority of which will be incurred by the REST-ON
trial and subsequent NDA filing. Selling, General &
Administrative (SG&A) expense is expected to be in the range of
$85 - $95 million. Included in SG&A is approximately $50 - $55
million of Selling & Marketing costs for Noctiva.
Excluding these launch costs, SG&A is expected to be in the
range of $35 – $40 million, down slightly from 2017. Given
the revenue, R&D and SG&A spending expectations and a $20
million Noctiva launch milestone payment due by June 30, 2018, the
Company expects negative cash flow in 2018. Currently, the
Company has a strong balance sheet and as a matter of good
corporate governance will continue to closely monitor its cash
requirements and as required will take steps to ensure adequate
liquidity to fund its strategic priorities. The Company is
currently assessing the Tax Cuts and Jobs Act of 2017 and,
accordingly, is unable to provide 2018 adjusted diluted EPS
guidance; however, it does not believe it will be required to pay a
significant amount of cash taxes during the year.
About Avadel Pharmaceuticals
plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a
specialty pharmaceutical company that seeks to develop
differentiated pharmaceutical products that are safe, effective and
easy to take through formulation development, by utilizing its
proprietary drug delivery technology and in-licensing / acquiring
new products; ultimately, helping patients adhere to their
prescribed medical treatment and see better results. The Company is
headquartered in Dublin, Ireland with operations in St. Louis,
Missouri, United States and Lyon, France. For more information,
please visit www.avadel.com.
About Noctiva™Noctiva is the
first and only formulation of desmopressin acetate, a vasopressin
analog, approved by the FDA for the treatment of nocturia due to
nocturnal polyuria in adults who awaken at least two times per
night to void. It is a proprietary low-dose formulation of
desmopressin acetate administered through a patent-protected
preservative-free intranasal delivery system. Noctiva is dosed as a
single spray in one nostril 30 minutes before bedtime, and is
approved in two dosage forms of 0.83 mcg and 1.66 mcg. Noctiva is
expected to become available to patients in the second quarter of
2018. (Full Prescribing Information available here).
Important Safety Information and
Indication for Noctiva (desmopressin acetate)
WARNING: HYPONATREMIA
- NOCTIVA can cause hyponatremia. Severe hyponatremia can
be life-threatening, leading to seizures, coma, respiratory arrest,
or death.
- NOCTIVA is contraindicated in patients at increased
risk of severe hyponatremia, such as patients with excessive fluid
intake, illnesses that can cause fluid or electrolyte imbalances,
and in those using loop diuretics or systemic or inhaled
glucocorticoids.
- Ensure serum sodium concentrations are normal before
starting or resuming NOCTIVA. Measure serum sodium within seven
days and approximately one month after initiating therapy or
increasing the dose, and periodically during treatment. More
frequently monitor serum sodium in patients 65 years of age and
older and in patients at increased risk of
hyponatremia.
- If hyponatremia occurs, NOCTIVA may need to be
temporarily or permanently discontinued.
Safe Harbor: This press release
may include forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. The words “will,” “may,”
“believe,” “expect,” “anticipate,” “estimate,” “project” and
similar expressions, and the negatives thereof, identify
forward-looking statements, each of which speaks only as of the
date the statement is made. Although we believe that our
forward-looking statements are based on reasonable assumptions
within the bounds of our knowledge of our business and operations,
our business is subject to significant risks and as a result there
can be no assurance that actual results of our research,
development and commercialization activities and our results of
operations will not differ materially from the results contemplated
in such forward-looking statements. These risks include: (i) risks
relating to our license agreement with Serenity Pharmaceuticals,
LLC including that our internal analyses may overstate the market
opportunity in the United States for the drug desmopressin acetate
(the “Drug”) or we may not effectively exploit such market
opportunity, that significant safety or drug interaction problems
could arise with respect to the Drug, that we may not successfully
increase awareness of nocturia and the potential benefits of the
Drug, and that the need for management to focus attention on the
development and commercialization of the Drug could cause our
ongoing business operations to suffer; and (ii) the other risks,
uncertainties and contingencies described in the Company's filings
with the U.S. Securities and Exchange Commission, including our
annual report on Form 10-K for the year ended December 31, 2016, in
particular under the captions “Forward-Looking Statements” and
“Risk Factors,” including without limitation: our dependence on a
small number of products and customers for the majority of our
revenues; the possibility that our Bloxiverz®,Vazculep® and Akovaz®
products, which are not patent protected, could face substantial
competition resulting in a loss of market share or forcing us to
reduce the prices we charge for those products; the possibility
that we could fail to successfully complete the research and
development for pipeline products we are evaluating for potential
application to the FDA pursuant to our "unapproved-to-approved"
strategy, or that competitors could complete the development of
such products and apply for FDA approval of such products before
us; the possibility that our products may not reach the commercial
market or gain market acceptance; our need to invest substantial
sums in research and development in order to remain competitive;
our dependence on certain single providers for development of
several of our drug delivery platforms and products; our dependence
on a limited number of suppliers to manufacture our products and to
deliver certain raw materials used in our products; the possibility
that our competitors may develop and market technologies or
products that are more effective or safer than ours, or obtain
regulatory approval and market such technologies or products before
we do; the challenges in protecting the intellectual property
underlying our drug delivery platforms and other products; and our
dependence on key personnel to execute our business plan. Except as
may be required by law, we disclaim any obligation to publicly
update any forward-looking statements to reflect events after the
date of this press release.
Non-GAAP Disclosures and
Adjustments
Avadel discloses certain non-GAAP financial
measures, including adjusted net income and loss and adjusted net
income and loss per diluted share, as management believes that a
comparison of its current and historical results would be difficult
if the disclosures were limited to financial measures prepared only
in accordance with generally accepted accounting principles (GAAP)
in the U.S. In addition to reporting its financial results in
accordance with GAAP, Avadel reports certain non-GAAP results that
exclude, if any, fair value remeasurements of its contingent
consideration, impairment of intangible assets, amortization of
intangible assets, restructuring costs, foreign exchange gains and
losses on assets and liabilities denominated in foreign currencies,
but includes the operating cash flows plus any unpaid accrued
amounts associated with the contingent consideration, in
order to supplement investors' and other readers' understanding and
assessment of the Company's financial performance. The
Company's management uses these non-GAAP measures internally for
forecasting, budgeting and measuring its operating
performance. Investors and other readers should review the
related GAAP financial measures and the reconciliation of non-GAAP
measures to their most closely applicable GAAP measure set forth
below and should consider non-GAAP measures only as a supplement
to, not as a substitute for or as a superior measure to, measures
of financial performance prepared in accordance with GAAP. The
table provided within the following “Supplemental Information”
section reconciles GAAP net income and loss and diluted earnings or
loss per share to the corresponding adjusted amounts.
Contacts: |
Michael F. Kanan |
|
Chief Financial Officer |
|
Phone: (636) 449-1844 |
|
Email: mkanan@avadel.com |
|
|
|
Lauren Stival |
|
Sr. Director, Investor Relations & Corporate
Communications |
|
Phone: (636) 449-5866 |
|
Email: lstival@avadel.com |
1 Data on file.
2 Sources: (1) US census data 2016 estimates (2) Lee, L. K., et
al. "Potential benefits of diagnosis and treatment…” International
journal of clinical practice 70.1 (2016): 66-81.
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