Expansion of National Salesforce Continues
for Mytesi as Napo Significantly Ramps Up Post-Merger Product
Commercialization and Launch Activities in Response to Impact of
Over 50% Sales Growth Since Merger
Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar), a commercial stage
natural-products pharmaceuticals company focused on developing
novel, sustainably derived gastrointestinal products for both human
prescription use and animals on a global basis, announced today
that gross sales for Mytesi® (crofelemer), the first-in-class,
FDA-approved anti-secretory human prescription drug product of
Jaguar’s wholly-owned subsidiary, Napo Pharmaceuticals, Inc.
(Napo), total approximately $2.8 million from January 1st, 2017
through October 31, 2017.
The average monthly Mytesi® sales from August through October of
this year increased over 50% relative to average monthly Mytesi®
sales that took place from January through July of 2017, which is
before substantial sales and marketing efforts were initiated in
the combined Company.
“The merger of Jaguar and Napo became effective on July 31,
2017. Napo’s receipt of cash is based on gross sales, defined as
cashflow from the movement of product from our third-party
logistics warehouse to wholesalers. Gross sales, in August,
September, and October of 2017, were approximately $1.1 mm for
Mytesi®. With the onboarding of three additional HIV sales
personnel this month, and the refilling rate of Mytesi®
prescriptions for a chronic disease, we expect continued growth for
future Mytesi® sales,” Lisa Conte, Jaguar's president and CEO,
stated.
Commercialization and distribution for Mytesi®, the only
antidiarrheal studied in and U.S. FDA-approved for the symptomatic
relief of noninfectious diarrhea in adults living with HIV/AIDS on
antiretroviral therapy (ART), initiated in the beginning of 2017,
and, until the second quarter of 2017, the effort was limited to
one full-time-equivalent sales representative. Following the merger
of Jaguar and Napo, Mytesi®-related commercial resources and
initiatives expanded to include a rollout of marketing, medical
education, advertising, and direct-to-consumer activities to
support what the Company had concluded was necessary for sales
representation—full-time representatives directly reporting to a
Napo national sales director. Napo now has a direct sales force of
seven highly trained representatives who report to Pete Riojas,
National Sales Director, and started calls to healthcare
professionals the week of October 16th, and the Company has hired
an additional three Mytesi® sales representatives, who start work
this month. Six of these new representatives are former long-term
employees of the HIV portfolio business of drugmaker Bristol-Myers
Squibb (BMS), and others possess extensive experience in drug sales
to both HIV healthcare providers and gastroenterologists.
GAAP Reported Mytesi® Revenues, Contrasted with
Operational Mytesi® Sales (a Cashflow
Activity)
The Company recognizes net Mytesi® revenue by deducting
allowances and medicaid charges from Mytesi® proceeds when product
moves from wholesalers to retail organizations. Gross sales figures
issued by the Company represent Mytesi® orders placed by
wholesalers with Jaguar’s third-party logistics warehouse which
generate invoiced sales and cashflow for Napo. As stated in the
third-quarter earnings report to be filed by Jaguar with the U.S.
Securities and Exchange Commission, which only includes Mytesi®
figures for the post-merger time period of August and September of
this year, Mytesi® revenue in August and September totaled
approximately $166,000 and $198,000, respectively. For the month of
October, 2017, Mytesi® revenue totaled approximately $207,000.
“No Mytesi® revenues from January 1 through July 31, 2017 are
reported in Jaguar’s financial results, as this time period was
prior to the effective date of the merger. However, the total
to-date sales of Mytesi®, along with the sales growth that the
merged organization has been able to achieve in short time through
substantial sales and marketing efforts, indicates the existence of
an important commercial asset,” commented Karen Wright, Jaguar’s
CFO, who supported the commercial launches of multiple prescription
products while with Genentech.
Note Regarding Use of Non-GAAP Measures
Gross sales is used internally by management as an indicator of
and to monitor operating performance, including sales performance
of Mytesi®, salesperson performance, and product growth or
declines. We believe that the presentation of gross sales provides
a closer to real-time useful measure of our operating performance.
Gross sales is not a measure that is recognized under accounting
principles generally accepted in the United States of America
(“GAAP”) and should not be considered as an alternative to net
sales, which is determined in accordance with GAAP, and should not
be used alone as an indicator of operating performance in place of
net sales. Additionally, gross sales may not be comparable to
similarly titled measures used by other companies, as gross sales
has been defined by our internal reporting practices. In addition,
gross sales may not be realized in the form of cash receipts as
promotional payments and allowances may be deducted from payments
received from certain customers.
Mytesi® is a prescription treatment for diarrhea that works
differently, by acting locally in the GI tract to normalize the
flow of water. Mytesi® does not have drug-drug interactions with
ART, does not affect GI motility, and has side effects that are
similar to placebo.
About Mytesi®
Mytesi® (crofelemer) is an antidiarrheal indicated for the
symptomatic relief of noninfectious diarrhea in adult patients with
HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated
for the treatment of infectious diarrhea. Rule out infectious
etiologies of diarrhea before starting Mytesi®. If infectious
etiologies are not considered, there is a risk that patients with
infectious etiologies will not receive the appropriate therapy and
their disease may worsen. In clinical studies, the most common
adverse reactions occurring at a rate greater than placebo were
upper respiratory tract infection (5.7%), bronchitis (3.9%), cough
(3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are
available at Mytesi.com. Crofelemer, the active ingredient in
Mytesi®, is a botanical (plant-based) drug extracted and purified
from the red bark sap of the medicinal Croton lechleri tree in the
Amazon rainforest. Napo has established a sustainable harvesting
program for crofelemer to ensure a high degree of quality and
ecological integrity.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage natural-products
pharmaceuticals company focused on developing novel, sustainably
derived gastrointestinal products for both human prescription use
and animals on a global basis. Our wholly-owned subsidiary, Napo
Pharmaceuticals, Inc., focuses on developing and commercializing
proprietary human gastrointestinal pharmaceuticals for the global
marketplace from plants used traditionally in rainforest areas. Our
Mytesi® (crofelemer) product is approved by the U.S. FDA for the
symptomatic relief of noninfectious diarrhea in adults with
HIV/AIDS on antiretroviral therapy. Mytesi® is in development for
multiple possible follow-on indications, including cancer
therapy-related diarrhea; orphan-drug indications for infants and
children with congenital diarrheal disorders and short bowel
syndrome; supportive care for inflammatory bowel disease (IBD);
irritable bowel syndrome (IBS); and as a second-generation
anti-secretory agent for use in cholera patients. Canalevia™ is our
lead animal prescription drug candidate, intended for treatment of
various forms of diarrhea in dogs. Equilevia™ is Jaguar’s
non-prescription product for total gut health in equine athletes.
Canalevia™ and Equilevia™ contain ingredients isolated and purified
from the Croton lechleri tree, which is sustainably harvested.
Neonorm™ Calf and Neonorm™ Foal are Jaguar’s lead non-prescription
animal products. Mytesi®, Canalevia™, Equilevia™ and Neonorm™ are
distinct products that act at the same last step in a physiological
pathway generally present in mammals.
For more information about Jaguar, please visit jaguar.health.
For more information about Napo, visit napopharma.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements.” These include statements regarding
Jaguar’s and Napo’s expectation that continued growth will occur
for future Mytesi® sales, and planned, potential follow-on
indications for Mytesi®. In some cases, you can identify
forward-looking statements by terms such as “may,” “will,”
“should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “potential” or “continue” or the negative of these terms
or other similar expressions. The forward-looking statements in
this release are only predictions. Jaguar has based these
forward-looking statements largely on its current expectations and
projections about future events. These forward-looking statements
speak only as of the date of this release and are subject to a
number of risks, uncertainties and assumptions, some of which
cannot be predicted or quantified and some of which are beyond
Jaguar’s control. Except as required by applicable law, Jaguar does
not plan to publicly update or revise any forward-looking
statements contained herein, whether as a result of any new
information, future events, changed circumstances or otherwise.
Jaguar-JAGX
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171114006727/en/
Jaguar Health, Inc.Peter Hodgephodge@jaguar.health
Jaguar Health (NASDAQ:JAGX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Jaguar Health (NASDAQ:JAGX)
Historical Stock Chart
From Apr 2023 to Apr 2024