Pacira BioSciences (NASDAQ: PCRX) - Investor Presentation January 2020 - Investors
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Pacira BioSciences (NASDAQ: PCRX) Investor Presentation January 2020
Forward-looking statements
Any statements in this presentation about the company’s future expectations, plans, outlook, projections and prospects, and
other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “could” and
similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various
important factors, including risks relating to: the success of the company’s sales and manufacturing efforts in support of the
commercialization of EXPAREL®; the rate and degree of market acceptance of EXPAREL®; the size and growth of the potential
markets for EXPAREL® and the company’s ability to serve those markets; the company’s plans to expand the use of EXPAREL® to
additional indications and opportunities, and the timing and success of any related clinical trials; the ability to successfully
integrate iovera° and MyoScience into the company’s existing business; the commercial success of iovera°; and other factors
discussed in the “Risk Factors” of the company’s most recent Annual Report on Form 10-K and in other filings that the company
periodically makes with the SEC. In addition, the forward-looking statements included in this presentation represent the
company’s views as of the date of this presentation. Important factors could cause actual results to differ materially from those
indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and
developments will cause its views to change. However, while the company may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied
upon as representing the company’s views as of any date subsequent to the date of this presentation.
2
A global leader in innovative non-opioid pain management and
regenerative health solutions
Three Global Growth Pillars
Mission
Provide an opioid alternative to as many
patients as possible 1 Growing Topline
Vision
Become a global leader in delivering
innovative non-opioid pain management 2 Pursuing Innovation
and regenerative health solutions
Core Values
Patient-centered, determined, passionate, Advancing Pipeline
innovative thinkers, trust builders, team driven
3
3
Expect continued topline growth to drive substantial operating
leverage and cash flow
• Broad EXPAREL adoption is accelerating Ramping revenues, cash flow and EBITDA
– Anesthesiologists expanding use of single- Revenue Opex (Incl. COGS) Adj. EBITDA
injection brachial plexus nerve and field blocks
– Opioid-sparing protocols shifting procedures to
23-hour stay environment – replace pumps,
catheters, opioids which require inpatient stay
– P4 studies solidifying proven safety & efficacy
– Pediatric and nerve block label expansion
• Expect high-teen YoY annual topline growth
for next five years
2019 2020 2021 2022 2023 2024
• Significant financial flexibility to capitalize
on internal/external growth opportunities
4
Growing topline
Three Global Growth Pillars
Expanding EXPAREL in key surgical setting
and establishing iovera° as the preferred
1 procedural solution for opioid-free total
knee arthroplasty/osteoarthritis and
peripheral nerve pain management
2 Pursuing Innovation
3 Advancing Pipeline
5
EXPAREL® is well-positioned for long-term market leadership
• EXPAREL remains the only:
– Non-opioid, long-acting option for local and Expanding use in key surgical
regional analgesia via infiltration, field block, and 1 settings and across new
brachial plexus nerve block indications and ex-US markets
– Product with proven, replicable non-opioid
postsurgical pain management through Enhanced
Recovery After Surgery (ERAS) opioid-sparing
protocols Driving awareness and
2 broadening access to
– Product with Level 1 evidence for opioid-free opioid-sparing solutions
postsurgical pain management in painful
procedures (TKA, rotator cuff, and C Section)
• Excellent safety profile; 6M+ patients treated to date
Partners with shared
commitment to innovative
3
opioid-sparing procedural
solutions
6
Key EXPAREL growth drivers gaining momentum
• Anesthesia-driven regional approaches becoming institutional protocols across key
procedures
• Mounting awareness around benefits of EXPAREL-based regional nerve and field blocks
– Presurgical block under ultrasound guidance provides several days of pain control (ERAS protocols)
– Pain control with low or no opioids allows for rapid ambulation and move to outpatient care
– Significant cost-savings for payers
– CMS and commercial payers mandating transition to Ambulatory Surgery Centers (ASC)
• TKA and several spine procedures added to Medicare’s approved list of ASC procedures
effective January 1, 2020
• Commercial Payers driving procedures to ASC to reduce cost and improve patient satisfaction
• 50+% of EXPAREL procedures taking place outside of inpatient hospital setting
• Strategic Partnerships with anesthesia groups driving education and training in regional
approaches
7
Expanding body of clinical evidence versus active comparators
Phase 3 Phase 4
Enrollment Enrollment Enrollment Enrollment Enrollment
Topline Topline Topline Topline Topline
sNDA Submission sNDA Submission Publication Publication Publication
PK and safety of Efficacy, safety & PK of Efficacy and safety of EXPAREL® in multimodal Efficacy and safety of
EXPAREL® in pediatric EXPAREL® vs bupivacaine EXPAREL® administered regimens vs standard of EXPAREL® fascia iliaca
subjects aged 6 to less administered as a lower via infiltration as a TAP care for lumbar posterior compartment block vs
than 17 years extremity nerve block block versus standard of spine surgeries standard of care in
lower extremity surgeries care in elective cesarean intertrochanteric hip
section fracture patients
Achieved primary Achieved primary
endpoint endpoint 8
JNJ partnership solidifying EXPAREL as a mainstay of opioid-sparing
strategies for painful orthopedic procedures
• Establishing strong demand in shoulder, spine,
sports medicine and total joint arthroplasty
– Successfully adapting marketing strategies and
resource allocation support continued migration of
key procedures to the ASC setting
• Expected to continue to deliver great value
through conclusion in 2021
– Benefiting from world class educational resources
– Leveraging significant commercial expertise in
preparation for future commercial expansion into
pediatrics and lower extremity nerve block
9
Growing coalition of like-minded collaborators
The only national organization focused on
primary prevention
CADCA: Rolling out national training
program to anti-drug coalitions in
communities across the US to educate
about how to access and advocate for
non-opioids to treat postsurgical pain
Leading medical group comprised of ≥25,000
providers across the nation
ENVISION: National series of interactive
workshops to train anesthesiology
clinicians on ultrasound-guided regional
anesthesia techniques utilizing long-acting
local anesthetics like EXPAREL
10iovera°: stopping pain…cold
The ioverao value proposition to stakeholders
• Immediate and long-term pain relief
• Safe repeated use for chronic pain
• Reduce pain to improve outcomes – before,
Patients
during and after surgery
• Procedural surgical solution used with
EXPAREL – improve outcomes, patientand
surgeon satisfaction
Healthcare • Can be used on hospital, hospital outpatient, Axon
providers ambulatory surgery or office settings Wallerian
Degeneration
Myelin
Endoneurium
• Supports move to outpatient care
• Reduce length of stay and total costs Focused Cold Therapy
Payers • Improved outcomes, accelerates recovery
11Initial commercial strategy focuses on two broad opportunities
+
Non-opioid pain management before, Drug-free, opioid-free, surgery-free
during and after surgery pain management for OA
12Pursuing innovation
Three Global Growth Pillars
1 Growing Topline
Acquisition targets ranging from
2 devices, therapeutics, cell therapeutics,
and regenerative medicine
3 Advancing Pipeline
13Building a differentiated portfolio focused on opioid-sparing
solutions for patients journey along the neural pain pathway
Rehabilitation
5
and recovery
4
Acute Surgery
Pre-surgical pain
3
(‘Prehabilitation’)
2
Osteoarthritis
Strategic focus: Building non-opioid franchises to 1
Pain; Injury/trauma
address unmet needs earlier in patient journey (Regenerative medicine)
14Sports medicine is a strategic area of focus
• Sports medicine market rapidly growing
opportunity driven by:
– Continuous influx of new products
– Increasing incidence of sports injuries
– Significant advances in the field of
regenerative medicine
• Opportunity to engage younger patients
earlier in neural pain pathway and
degenerative conditions
• Well-defined physician group
• ASC site of care
• Seeking niche spaces not occupied by
larger players
15Advancing pipeline
Three Global Growth Pillars
1 Growing Topline
2 Pursuing Innovation
Advancing new opportunities for
3 non-opioid acute and chronic pain
management applications
16Advancing a pipeline of non-opioid opportunities for acute and
chronic pain management
DepoLevobupivacaine
• DepoFoam is the only delivery technology allowing for
Intrathecal or subarachnoid delivery
• Potential alternative to the use of opioids typically delivered as
epidural or spinal – replace opioids to reduce adverse events
and improve early recovery with several days of pain control
• Procedure done as routine by anesthesia practitioners
• Program discussed with FDA; preparing to initiate study
17Financial performance1
• 4Q19 total revenue: $122.4M (up 29% over prior year) Net EXPAREL® & iovera° sales
($ in millions)
– Net EXPAREL® sales: $116.9M (up 24% over prior year)
23%
• 2019 revenue: $421.0M (up 25% over prior year) YoY growth
• 2019 Guidance: $416
EXPAREL® net sales: $407.9M $408
ioverao net sales2: $7.9M
$331
– Non-GAAP margins: 75-76%
– Non-GAAP R&D: $60-70M $283
$266
– Non-GAAP SG&A: $180-190M
– Stock-based compensation: $30-35M
2016 2017 2018 2019
EXPAREL® iovera°
1 4Q19 and FY2019 results are preliminary and unaudited.
2 From April 9, 2019 acquisition date onward. 18Looking ahead: 2020 will be driven by opioid-sparing innovation
TLR from P4 opioid- EXPAREL China EXPAREL in pediatrics
free CHOICE study regulatory pathway market approval
Pediatrics EXPAREL Additional anesthesia P4 opioid-free CHOICE
sNDA submission partnerships study publication
Growing Topline
TLR from P3 lower Lower extremity NB Identify additional
extremity NB study study completion iovera° opportunities
EXPAREL approved iovera° TKA & ACL Develop & publish iovera°
in EU & Canada clinical trials best practice pathways
Access complementary assets
Pursuing Innovation via business development
DepoLevobupivacaine data DepoDexmedetomidine data
Advancing Pipeline for advancement to clinical for advancement to clinical
stage decision stage decision
19Thank you
Important safety information for EXPAREL® patients
• EXPAREL® should not be used in obstetrical paracervical block anesthesia.
• In studies where EXPAREL® was injected into the wound, the most common side effects were nausea, constipation, and vomiting.
• In studies where EXPAREL® was injected near a nerve, the most common side effects were nausea, fever, and constipation.
• EXPAREL® is not recommended to be used in patients younger than 18 years old or in pregnant women.
• Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL® is eliminated from your body.
• EXPAREL® should not be injected into the spine, joints, or veins.
• The active ingredient in EXPAREL®:
– Can affect your nervous system and your cardiovascular system
– May cause an allergic reaction
– May cause damage if injected into your joints.
21Important safety information for iovera°
About iovera°
• The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by
the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for
up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. The iovera° system’s “1×90” Smart Tip configuration (indicating one
needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is
not indicated for treatment of central nervous system tissue.
Important Safety Information
• The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud’s disease; open
and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for
temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or
tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by
applying ice packs to the affected sites, and by taking over-the counter analgesics.
• The ioverao system is used to destroy tissue during surgical procedures by applying freezing cold.
• It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain.
• It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days.
• The iovera° system is not indicated for treatment of central nervous system tissue.
• The ioverao system’s “1×90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve
stimulation from a separate nerve stimulator.
• The ioverao system is not indicated for treatment of central nervous system tissue.
22You can also read
