TIDMPRTC
PureTech Health PLC
21 June 2022
21 June 2022
PureTech Health plc
PureTech Founded Entity Gelesis Announces Additional $15 Million
Pre-Order for Plenity(R), Bringing Total Pre-Paid Orders from Ro
for Plenity to $55 Million
Following the successful debut of the national broad awareness
media campaign, with a new record-high for prescription requests,
Gelesis' telehealth distribution partner, Ro, placed an additional
pre-order for the weight management product
Gelesis received $45 million in pre-paid orders from Ro in the
last 12 months
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company noted that its
Founded Entity, Gelesis Holdings, Inc. (NYSE: GLS) ("Gelesis"), a
consumer-focused biotherapeutics company, announced that Ro, a
leading and rapidly growing U.S. direct-to-patient healthcare
company, has placed a $15 million pre-paid order for Gelesis'
commercial product for weight management, Plenity(R). This is in
addition to previous Plenity pre-orders from Ro totaling $40
million.
Gelesis launched the first wave of its national broad awareness
media campaign for Plenity on January 31, 2022, which corresponded
with record high levels of web traffic and prescription requests.
Since the broad consumer launch, Plenity has become one of the most
sought-after offerings on Ro's platform. Following the launch of
the campaign, the number of individuals seeking a new prescription
increased 140% during the first quarter to reach record highs.
Gelesis reported $7.5 million in net product revenue in the first
quarter of 2022, a 142% increase over the first quarter 2021.
The full text of the announcement from Gelesis is as
follows:
Gelesis Announces Additional $15 Million Pre-Order for
Plenity(R), Bringing Total Pre-Paid Orders from Ro for Plenity to
$55 Million
Following the successful debut of the national broad awareness
media campaign, with a new record-high for prescription requests,
the company's telehealth distribution partner, Ro, placed an
additional pre-order for the weight management product
Gelesis received $45 million in pre-paid orders from Ro in the
last 12 months
BOSTON, June 21, 2022 - Gelesis announced today that Ro, a
leading and rapidly growing U.S. direct-to-patient healthcare
company, has placed a $15 million pre-paid order for the company's
commercial product for weight management, Plenity(R). This is in
addition to previous Plenity pre-orders from Ro totaling $40
million.
Gelesis launched the first wave of its national broad awareness
media campaign for Plenity on January 31, 2022, which corresponded
with record high levels of web traffic and prescription requests.
Since the broad consumer launch, Plenity has become one of the most
sought-after offerings on Ro's platform. After a consultation with
a licensed healthcare provider, if they qualify, individuals can be
approved for a prescription within 24 hours. The treatment is then
shipped directly to their home and arrives within 2 days, at $98
for a 28-day supply.
"We believe we are highly differentiated in the rapidly growing
weight management category with a treatment option that is
available across a wide BMI spectrum and where our members can
continue to enjoy the foods they love, feeling satisfied with
smaller portions," said David Pass, Pharm. D, Gelesis' Chief
Commercial and Operating Officer. "We believe that access to well
tolerated, affordable, evidence-based care is one of the biggest
barriers in effective weight management. We are excited to see the
growing indicators of the success of our commercial model. We have
acquired more than half of our members since the start of the media
campaign in February."
Following the launch of the campaign, the number of individuals
seeking a new prescription increased 140% during the first quarter
to reach record highs. The company reported $7.5 million in net
product revenue in the first quarter of 2022, a 142% increase over
the first quarter 2021.
Gelesis has also reported growth in the more traditional
healthcare provider (HCP) channel following the launch of the
campaign and the company expects consumer demand to continue to
drive uptake. Notably 40-50% of these HCP prescriptions were
requested by the consumer (the company's baseline before the media
campaign began was 25%).
Plenity has the largest addressable market of any prescription
weight management approach, and 150 million American adults could
qualify for treatment, including the tens of millions of Americans
with a BMI between 25 and 30 who generally do not qualify for other
prescription weight loss treatments. About 70% of Plenity members
had never tried a prescription weight management product before,
indicating Plenity is bringing new people into the category of
prescription weight management products.
About Gelesis
Gelesis Holdings Inc. (NYSE: GLS) ("Gelesis") is a
consumer-centered biotherapeutics company and the maker of
Plenity(R), which is inspired by nature and FDA cleared to aid in
weight management. Our first-of-their-kind non-systemic
superabsorbent hydrogels are made entirely from naturally derived
building blocks. They are inspired by the composition and
mechanical properties of raw vegetables, taken by capsule, and act
locally in the digestive system, so people feel satisfied with
smaller portions. Our portfolio includes Plenity(R) and potential
therapies in development for patients with Type 2 Diabetes,
Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic
Steatohepatitis (NASH), and Functional Constipation. For more
information, visit gelesis.com , or connect with us on Twitter
@GelesisInc.
Plenity(R) is indicated to aid weight management in adults with
excess weight or obesity, a Body Mass Index (BMI) of 25-40 kg/m(2),
when used in conjunction with diet and exercise.
Important Safety Information about Plenity
-- Patients who are pregnant or are allergic to cellulose,
citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide
should not take Plenity.
-- To avoid impact on the absorption of medications:
o For all medications that should be taken with food, take them
after starting a meal.
o For all medications that should be taken without food (on an
empty stomach), continue taking on an empty stomach or as
recommended by your physician.
-- The overall incidence of side effects with Plenity was no
different than placebo. The most common side effects were diarrhea,
distended abdomen, infrequent bowel movements, and flatulence.
-- Contact a doctor right away if problems occur. If you have a
severe allergic reaction, severe stomach pain, or severe diarrhea,
stop using Plenity until you can speak to your doctor.
Rx Only. For the safe and proper use of Plenity or more
information, talk to a healthcare professional, read the Patient
Instructions for Use , or call 1-844-PLENITY.
Forward-Looking Statements
Certain statements, estimates, targets and projections in this
press release may constitute "forward-looking statements" within
the meaning of the federal securities laws. The words "anticipate,"
"believe," continue," "could," "estimate," "expect," "intend,"
"may," "might," "plan," "possible," "potential," "predict,"
"project," "should," "strive," "would" and similar expressions may
identify forward-looking statements, but the absence of these words
does not mean that statement is not forward-looking.
Forward-looking statements include, but are not limited to,
statements regarding Gelesis' or its management team's
expectations, hopes, beliefs, intentions or strategies regarding
the future, including statements regarding projections, forecasts,
or other characterizations of future events or circumstances,
including any underlying assumptions. Such forward-looking
statements are based on the information currently available to
Gelesis and on assumptions Gelesis has made and, as a result, such
statements are subject to risks and uncertainties. Gelesis intends
these forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Exchange Act, and
Gelesis makes this statement for purposes of complying with those
safe harbor provisions. Forward-looking statements speak only as of
the date they are made. Readers are cautioned not to put undue
reliance on forward-looking statements, and Gelesis assumes no
obligation and does not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise. Gelesis gives no assurance that any
expectations set forth in this press release will be achieved.
Various risks and uncertainties (some of which are beyond Gelesis'
control) or other factors could cause actual future results,
performance or events to differ materially from those described
herein. Some of the factors that may impact future results and
performance include, without limitation: (i) the size, demand and
growth potential of the markets for Plenity(R) and Gelesis' other
product candidates and Gelesis' ability to serve those markets;
(ii) the degree of market acceptance and adoption of Gelesis'
products; (iii) Gelesis' ability to develop innovative products and
compete with other companies engaged in the weight loss industry;
(iv) Gelesis' ability to finance and complete successfully the
commercial launch of Plenity(R) and its growth plans, including new
possible indications and the clinical data from ongoing and future
studies about liver and other diseases; (v) failure to realize the
anticipated benefits of the business combination between Gelesis
and Capstar Special Purpose Acquisition Corp. ("Capstar"),
including as a result of a delay or difficulty in integrating the
businesses of Capstar and Gelesis; (vi) the ability of Gelesis to
issue equity or equity-linked securities or obtain debt financing
in the future; (vii) Gelesis' ability to continue as a going
concern; (viii) the outcome of any legal proceedings instituted
against Capstar,
Gelesis, or others in connection with the business combination;
(ix) the ability of Gelesis to maintain its listing on the New York
Stock Exchange; (x) the risk that the business combination disrupts
the plans and operations of Gelesis as a result of Gelesis being a
publicly listed issuer; (xi) the regulatory pathway for Gelesis'
products and responses from regulators, including the FDA and
similar regulators outside of the United States; (xii) the ability
of Gelesis to grow and manage growth profitably, maintain
relationships with customers and suppliers and retain Gelesis'
management and key employees; (xiii) costs related to the business
combination, including costs associated with Gelesis being a
publicly listed issuer; (xiv) changes in applicable laws or
regulations; (xv) the possibility that Gelesis may be adversely
affected by other economic, business, regulatory and/or competitive
factors; (xvi) Gelesis' estimates of expenses and profitability;
(xvii) ongoing regulatory requirements, (xviii) any competing
products or technologies that may emerge, (xix) the volatility of
the telehealth market in general, or insufficient patient demand;
(xx) the ability of Gelesis to defend its intellectual property and
satisfy regulatory requirements; (xxi) the impact of the COVID 19
pandemic on Gelesis' business; (xxii) the limited operating history
of Gelesis; (xxiii) the potential impact of inflation on Gelesis'
operating expenses and costs of goods; and (xxiv) other important
factors discussed in the "Risk Factors" section of Gelesis' most
recent Annual Report on Form 10-K, and in other filings that
Gelesis makes with the Securities and Exchange Commission. These
filings address other important risks and uncertainties that could
cause actual results and events to differ materially from those
contained in the forward-looking statements.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders.
This pipeline, which is being advanced both internally and
through PureTech's Founded Entities, is comprised of 27
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Annual Report and corresponding Form 6-K. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on unique insights in immunology and drug development.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation those statements that relate to Gelesis'
marketing strategies and the competitive environment in which
Gelesis operates, and Gelesis' and PureTech's future prospects,
development plans, and strategies. The forward-looking statements
are based on current expectations and are subject to known and
unknown risks, uncertainties and other important factors that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks, uncertainties and other important factors
described under the caption "Risk Factors" in our Annual Report on
Form 20-F for the year ended December 31, 2021 filed with the SEC
and in our other regulatory filings. These forward-looking
statements are based on assumptions regarding the present and
future business strategies of the Company and the environment in
which it will operate in the future. Each forward-looking statement
speaks only as at the date of this press release. Except as
required by law and regulatory requirements, we disclaim any
obligation to update or revise these forward-looking statements,
whether as a result of new information, future events or
otherwise.
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media
Nichole Sarkis
+1 774 278 8273
nichole@tenbridgecommunications.com
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