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
SAN FRANCISCO--(BUSINESS WIRE)--Nov. 14, 2017--
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/
Source: Jaguar Health, Inc.
Jaguar Health, Inc.
Peter Hodge
phodge@jaguar.health
