Recro Pharma, Inc. - FORM 8-K - EX-99.2

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EX-99.1 - EX-99.1 - Recro Pharma, Inc.	d152376dex991.htm
8-K - 8-K - Recro Pharma, Inc.	d152376d8k.htm

Relieving pain…….Improving lives

Exhibit 99.2

Special Note Regarding Forward-Looking

Statements

This presentation includes 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. These statements, among other things, relate to our business strategy, goals

and expectations concerning our product candidates, future operations, prospects,

plans and objectives of management. The words "anticipate", "believe", "could",

"estimate", "expect", "intend", "may", "plan", "predict", "project", "will" and similar terms

and phrases are used to identify forward-looking statements in this presentation. Our

operations involve risks and uncertainties, including the integration of our recently

acquired assets, many of which are outside our control, and any one of which, or a

combination of which, could materially affect our results of operations and whether the

forward-looking statements ultimately prove to be correct. These forward-looking

statements should be considered together with the risks and uncertainties that may

affect our business and future results included in our filings with the Securities and

Exchange Commission at www.sec.gov. These forward-looking statements are based

on information currently available to us, and we assume no obligation to update any

forward-looking statements except as required by applicable law.

Company Highlights

•

Multiple non-opioid therapeutics in advanced clinical

development for acute post operative pain

•

IV/IM

meloxicam

Phase

III

ready –

long

acting,

demonstrated efficacy in successful Ph II trials

•

Dex-IN –

proprietary,

intranasal

therapeutic

with

recently announced positive Ph II results

•

Revenue and cashflow

positive manufacturing &

royalty business

•

Experienced management team with significant

development, regulatory and commercial experience

Experienced Management and Board

•

Gerri

Henwood

–

President

and

CEO

Founded Auxilium

Pharmaceuticals (AUXL,

NASDAQ) and IBAH (former NASDAQ Co.

–

acquired 1998); GSK

•

Chuck

Garner

–

CFO,

CBO

and

Treasurer

Over 14 years of life sciences investment

banking experience –

Deutsche Bank, Burrill

& Co., Inverness Advisors; PwC

•

Randy

Mack

–

SVP,

Development

Over 20 years of clinical development

experience

–

Adolor,

Auxilium,

Abbott

Labs

and Harris Labs

Board of Directors

Wayne

Weisman –

Chairman

SCP VitaLife

Partners

Winston J. Churchill

SCP VitaLife

Partners

Gerri

Henwood

–

CEO

William L. Ashton

Harrison Consulting Group; frmly

Amgen

Abraham Ludomirski, M.D.

SCP VitaLife

Partners

Alfred Altomari

CEO, Agile Therapeutics

Michael Berelowitz, M.D.

Former SVP, Specialty Care Business

Unit, Pfizer

Recent Transformative Transaction

•

Acquired IV/IM meloxicam and manufacturing & royalty

business from Alkermes

–

$50M up-front cash payment; meloxicam milestones and royalties

–

Warrants

issued

Alkermes

and

OrbiMed

–

Non-dilutive up-front financed by loan from OrbiMed

•

IV/IM

meloxicam

–

long

acting

preferential

COX-2

inhibitor

for

moderate

severe

acute

pain

ready

for

III

–

Widely prescribed, approved oral chronic pain therapeutic

–

Multiple Phase II studies successfully completed in acute pain

models

–

Dosing advantages over existing acute pain therapeutics, including

long action

•

Manufacturing, royalty and formulation business

–

87,000 sq. ft. facility (DEA licensed) manufactures 5 commercial

products marketed by partners

–

$75M in revenues and cashflow

positive (2014)

Positive Dex-IN Ph II Results

(REC-14-013

–

Post

Day

Dosing)

•

Randomized, placebo

controlled

Phase

bunionectomy

study

(168 patients)

–

Randomized, placebo controlled study

–

50 mcg of Dex-IN or placebo every 6 hours

–

Primary

endpoint

–

SPID48

(p=0.0214)

–

Oral opioid rescue therapy allowed

•

6 patients discontinued for lack of efficacy (3 in each treatment

group) and 1 patient due to serious adverse event of hypotension

•

Most common adverse events observed in the study were:

–

blood pressure decrease / hypotension

–

nausea (similar incidences to placebo)

–

nasal discomfort and headache

•

Adverse event of bradycardia was reported in 3 subjects in the

Dex-IN treatment group

Clinical Stage Pipeline

Product

III

Rights

Meloxicam

IV formulation

Acute post operative pain

Phase III ready

IM formulation

Acute pain

Dexmedetomidine

(“Dex”)

WW, exc. Europe, Turkey, CIS

Dex-IN (intranasal)

Acute post operative pain

Cancer breakthrough pain

Dex-SL (sublingual)

Fadolmidine

(“Fado”)

WW, exc. Europe, Turkey, CIS

Intrathecal

Topical

Post Op Pain Market Underserved

•

$5.9 billion market

(1)

•

Predominantly opioid

use

•

Significant side

effects / issues

associated with

opioids

•

Dearth of non-opioid

drugs in development

Inpatient procedures

Total procedures (2009)

47.9M

Addressable

>25M

Ambulatory procedures

Total procedures (2006)

53.3M

Addressable

>25M

Note: Addressable includes procedures expected to

utilize pain medication.

Source: National Center for Health Statistics and

management estimates.

(1) GBI Research, 2010 sales.

Limited Pain Relief Options for Patients

Pain

Severity

Class

Compounds

Advantages

Disadvantages

Mild

Acetaminophen

Antipyretic properties;

Oral; no opioid AEs

Only effective for mild pain; short

acting

NSAIDs

Ketorolac,

ibuprofen, aspirin

Mild to moderate

analgesia; oral; no

opioid AEs

Bleeding risk; GI and renal

complications; short acting

Moderate

Sodium channel

blockers

Bupivacaine,

lidocaine

Use directly at pain

site; mostly peri-

operative

Limited duration of action; some are

concerned about local tissue impact

Moderate to

Severe

Long-acting

preferential COX-2

IV/IM meloxicam

(Recro Pharma)

Long acting; fast onset,

high pain relief, and

less constipation

Bleeding risk; GI and renal

complications

Alpha 2 agonists

Dexmedetomidine

(Recro Pharma)

Good pain relief;

anxiolytic properties;

no respiratory

depression, impaired GI

or addictive properties

In development –

potential for first in

class to be approved for post-

operative pain

Opioids

Morphine,

hydrocodone,

oxycodone, fentanyl

Good pain relief

Respiratory depression, impaired GI

motility after even one dose;

frequent nausea and vomiting;

abuse/addiction potential

Note: Pain severity based upon market research / physician feedback

IV/IM Meloxicam

IV/IM Meloxicam Overview

•

FDA approved, oral preferential COX-2 inhibitor

used in a wide variety of indications

•

Proprietary long acting injectable form for moderate

to severe acute pain

–

Incorporates Alkermes’ NanoCrystal™ technology

•

Phase

III

ready

–

multiple

Phase

studies

completed on IV and a Phase I on IM

–

Positive Ph

II hysterectomy and dental pain studies with

demonstrated efficacy

•

IP issued through 2022 and additional IP could

extend protection through 2030

NanoCrystal

registered

trademark

Alkermes

plc.

Favorable Dosing Profile

Attribute

Meloxicam

Ketorolac

Caldolor

(ibuprofen)

Ofirmev

(APAP)

Route

IV/IM

Onset of pain

relief

< 10 min

30 min

N/A

Time to peak

analgesic effect

40 min

1-2 hrs

N/A

Duration of

pain relief

18-24

hrs

4-6 hrs

Admin.

IV bolus / pre-

filled syringe

(later)

Ready to use IV

bolus (15 sec)

Dilution required,

30 min infusion

Ready to use,

min infusion

IV/IM Meloxicam Clinical Overview

•

Elan/ALKS conducted 5 IV and 1 IM clinical trials

–

Two Phase 1 IV PK & Safety trials

–

One Phase 1 IM PK & Safety trial

–

Three Phase 2 IV efficacy trials in various acute pain

models

•

Good safety & tolerability across large dose range

IV/IM

•

Demonstrated efficacy using various measures in

multiple pain models

Multiple Successful IV Phase 2 Trials

•

Elan/ALKS have conducted 5 IV and 1 IM clinical trials

Trial

Design

Outcome

Phase II Study

N1539-02

Acute pain following dental

surgery (N = 230)

Statistically significant differences for all

doses compared to placebo were seen in

SPID24, pain relief and onset of pain relief

Phase II Study

N1539-04

Acute pain following open

abdominal hysterectomy

surgery (N = 486)

Statistically significant differences for all

doses compared to placebo were seen in

multiple efficacy analyses, including SPID24.

meloxicam 30 mg and 60 mg produced the

greatest response with no difference

between doses

Phase II Study

N1539-05

Acute pain following

laparoscopic abdominal

surgery (N =50)

Study stopped early (planned N = 250) for

business reasons. However, statistically

significant differences in SPID48 observed for

30mg QD dose despite small sample size

Phase II Abdominal Hysterectomy Study

•

Multicenter, single-dose, randomized, double-blind,

placebo-

& active-controlled study in Eastern Europe

•

In double-blind period, single doses of:

–

Placebo

–

IV Morphine (10-15 mg)

–

Meloxicam 5 mg, 7.5 mg, 15 mg, 30 mg, 60 mg

–

After 24 hours, open-label Meloxicam was available

•

Standard analgesia study design

–

Pain Intensity assessments (SPID24 = Primary Endpoint)

–

Pain Relief

–

Rescue mediation

–

Time to onset

Robust Efficacy

(Abdominal

Hysterectomy

Trial

–

Meloxicam)

*** p < 0.001 vs. Placebo

***

(10,000)

10,000

20,000

30,000

40,000

50,000

60,000

Placebo

n=64

Morphine

n=62

5 mg

n=60

7.5 mg

n=91

15 mg

n=60

30 mg

n=60

60 mg

n=89

Confirmed Efficacy in Multiple Studies

Summary of Pain Intensity Differences (SPID)

*** p < 0.001 vs. Placebo

Dental Pain Study

p = 0.0682

p = 0.0392

Abdominal Laparoscopic Pain Study

20000

40000

60000

80000

100000

120000

140000

160000

180000

200000

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

***

Single 30 mg Dose Performance over 24 hrs

(Abdominal Hysterectomy

Trial

–

Meloxicam)

Baseline Pain Level

-10

Time (Hours)

Placebo n=64

Morphine n=62

15 mg n=60

30 mg n=60

60 mg n=89

Well Tolerated

(Abdominal

Hysterectomy

Trial

–

Meloxicam)

**Reported in

3% of Subjects in any group and greater than Placebo

Meloxicam

Placebo

n=64

Morphine

n=62

5 mg

n=60

7.5 mg

n=91

15 mg

n=60

30 mg

n=60

60 mg

n=89

Anemia

3.1

4.8

3.3

13.2

3.3

1.7

10.1

Anemia Postoperative

1.6

3.3

Constipation

4.8

5.0

1.1

1.7

Flatulence

4.8

1.7

1.1

3.3

Hypokalaemia

3.2

1.7

1.1

1.7

Insomnia

4.7

8.1

10.0

4.4

5.0

4.5

Ketonuria

7.8

9.7

6.7

9.9

10.1

Leukocytosis

1.7

3.3

Pyrexia

1.6

3.2

3.3

2.2

Sinus Tachycardia

3.3

1.1

Percent of Subjects Reporting an Adverse Event **

Next Steps for IV Meloxicam

•

Production of a clinical supply batch

•

Conduct Phase III Pivotal Study in hard and soft

tissue models

•

Verify need for additional safety studies to meet

adequate exposures / special populations

Dexmedetomidine

(“Dex”)

Dex

Has Demonstrated Analgesia & Safety

•

Alpha 2 agonist (non-opioid)

–

Injectable

form

(Precedex)

marketed

Hospira

sedative

–

Multiple studies demonstrating analgesia of alpha 2 agonists

•

Intranasal formulation in clinical development for acute

pain

–

In-licensed non-IV rights from Orion

–

Worldwide

rights

except

Europe,

Turkey,

and

CIS

•

Multiple

studies

demonstrate

Dex

pain

relief

and

safe

profile

–

Including our completed placebo controlled trials

•

Expect strong IP position

–

Pending IP coverage could run through 2030

•

Expect to file 505(b)(2) NDA after completion of Ph

III

Dex

Efficacy and Safety in Multiple Studies

Beneficial effects

Source

Approved sedative and safe profile

NDA filing / pivotal trials -

Abbott/Hospira, Orion

Morphine sparing

NDA studies plus Literature

Analgesia by IV route

Chan, 2010; Grosu, 2010; Lin, 2009, Arain,

2010

Demonstration of pain relief (VAS)

Placebo controlled trials; L. Webster, MD

(Utah) CLBP study (Recro sponsored)

Positive PK/PD plasma levels

demonstrating analgesic potential

Clinical trials run by Recro

Relieves morphine “Max”

(‘hyperalgesia’)

University of Minnesota; M. Belgrade, MD

Significant Advantages Over Opioids

Dex

Fast-acting Opioids

Non-opioid (Not controlled substance)

Opioid -

DEA scheduled product

No habituation effects

Addictive

Does not cause respiratory depression

Respiratory depression

Not associated with constipation,

nausea, or vomiting

Unwanted side-effects of constipation,

nausea and vomiting

Enhances morphine effectiveness

without morphine dose increase

Additive effect requires higher dose

More cognitively intact

Frequently “Foggy”/ may be confused

Anxiolytic

properties

Not anxiolytic

Effective Analgesic

Dex

Has Been Well Studied by Recro

•

Evaluated proprietary formulations of Dex

in 10 trials

Trial

Form

Design

Outcome

REC-14-013

Dex-IN

Acute pain following

bunionectomy

surgery

(n=168)

Statistically significant difference of

SPID48 between 50 mcg of Dex-IN vs.

placebo (p=0.0214)

REC-13-012

Dex-IN

Acute pain following

bunionectomy

surgery

(n=85 evaluable)

Within subset of patients (n=42), with

baseline pain intensity of 6 or below,

there was a trend towards analgesia in 50

mcg and reduced opioid use vs placebo

REC-11-010

Dex-IN

Chronic lower back pain

POC study (n=24)

Statistically significant pain relief within

30 minutes demonstrated in placebo

controlled

trial

–

single

use

device

REC-09-003

Dex-SL

Chronic lower back pain

POC study (n=21)

Statistically significant reduction in pain

intensity demonstrated in placebo

controlled trial

Dex-IN Study REC-14-013

(US placebo controlled trial)

•

Phase II bunionectomy

study

–

Randomized, placebo controlled study

–

Primary

endpoint

–

SPID48

–

Oral opioid rescue therapy allowed

–

Post Op Day 1 dosing

•

50 mcg of Dex-IN or placebo every 6 hours

–

84 patients in each treatment group (168 in total)

•

Additional secondary endpoints included:

–

Use of opioid rescue medication

–

SPIDs over various time intervals

–

Other standard efficacy analyses

•

Patients followed for 7 days after initial dosing

Study REC-14-013

(SPID48

–

Primary

Endpoint)

Note: Last Observation Carried Forward Analysis Method

p = 0.0214

500

1000

2000

2500

3000

Placebo N = 84

DEX-IN 50 µg N = 84

1500

Study REC-14-013

(Subject Characteristics)

Placebo

(N=84)

DEX-IN 50 µg

(N=84)

Female, n (%)

75 (89.3)

79 (94.0)

Age, Mean

43.9

(range)

(46 -

70)

(46 -

69)

Discontinued Subjects, n (%)

3 (3.6)

4 (4.8)

Lack of Efficacy

3 (3.6)

Adverse Event

1 (1.2)**

Race, n (%)

White

56 (66.7)

59 (70.2)

Black/African American

21 (25.0)

20 (23.8)

Other

7 (8.4)

5 (6.0)

Baseline PI Score, Mean

6.7

6.4

(range)

(4 -

10)

(4 -

10)

**Serious Adverse Event of Hypotension

Study REC-14-013

(Adverse Events –

3 in Dex-IN Group)

•

If IV fluid given and no symptoms present, “BP Decrease”

recorded as AE

•

No medication given to any patient with BP or HR change

•

All nasal related AEs were rated as mild, except one case of nasal

congestion rated as moderate

Adverse Event

Placebo

(N=84)

DEX-IN 50 µg

(N=84)

BP Decreased

3 (3.6%)

22 (26.2%)

Nausea

14 (16.7%)

13 (15.5%)

Nasal Discomfort

2 (2.4%)

7 (8.3%)

Headache

4 (4.8%)

6 (7.1%)

Vomiting

6 (7.1%)

4 (4.8%)

Nasal Dryness

3 (3.6%)

4 (4.8%)

Nasal Congestion

1 (1.2%)

4 (4.8%)

Nasal Obstruction

2 (2.4%)

3 (3.6%)

Bradycardia

3 (3.6%)

Dizziness

1 (1.2%)

3 (3.6%)

Hypotension

3 (3.6%)

Clinical Pipeline Intellectual Property

•

IV/IM meloxicam

–

formulation

through

2022

–

Additional IP filed could run to 2030

•

Dex applications for methods for treating/preventing pain

through intranasal

and

sublingual

formulations

without

significant sedation

•

Fado

IP in-licensed from Orion

–

Composition of matter

–

Method of administration for analgesia

–

Treatment and prevention of hypotension and shock

–

Pro-Drug

•

Regulatory exclusivity

–

505(b)(2)

–

years

(Meloxicam,

Dex-IN,

Dex-SL)

–

505(b)(1)

–

NCE,

years

(Fado)

Fadolmidine

(“Fado”)

Fado

Effective in Phase II for Pain Relief

•

Alpha 2 agonist

–

more potent at the alpha 2c receptor than Dex

–

>20 fold less potent at the alpha 1b receptor than clonidine

•

Fado

has demonstrated analgesia in multiple animal models

•

Positive

Phase

analgesia

study

bunionectomy

patients

–

Intrathecal route of administration

•

Formulation work underway for topical prototype

–

Potential in regional neuropathies

•

WW rights to all human uses except Europe, Turkey and CIS

•

NCE

patent

expected

extension

2021

pursuing

add’l

Corporate Overview

US Based Manufacturing Facility

Manufacturing & Royalty Overview

Manufacturing

facility

•

87,000 sq. ft. solid oral dosage manufacturing cGMP

•

DEA licensed

•

~165 employees

Service capabilities

•

Formulation,

process

development

and

optimization

•

Process scale-up

•

Clinical supply and validation

•

Commercial supply

Ritalin LA

•

Once

daily ADHD treatment

marketed by Novartis

Focalin

•

ADHD treatment marketed by Novartis

Verelan

/ verapamil

•

CV/High blood pressure treatment

marketed by Actavis

and UCB

Zohydro

•

Extended release hydrocodone marketed by Pernix

•

Launched

in 2014

•

Abuse deterrent form launched

Strong Historical Manufacturing Performance

•

Carve-out financials

•

Zohydro

ER –

abuse deterrent form launched

•

Additional capacity for new product opportunities

•

Positive cashflow

expected to cover all debt service

obligations and excess cashflows

to repay loan

principal

*EBITDA is a non-GAAP financial metric. Please see slide 38 for additional information including a

reconciliation of Net Income to EBITDA.

(in millions)

12 months ended

Dec.

31, 2014

(audited)

3 months ended

March 31, 2015

3 months ended

March 31, 2014

Revenues

$75.2

$19.4

$16.6

EBITDA*

$29.2

$5.2

$6.8

Company Highlights

•

Multiple non-opioid therapeutics in mid to late stage

clinical development for acute post operative pain

•

IV/IM

meloxicam

Phase

III

ready

–

long

acting,

demonstrated efficacy in successful Ph II trials

•

Dex-IN

–

proprietary,

intranasal

therapeutic

with

recently announced positive Ph II results

•

Revenue and cashflow

positive manufacturing &

royalty business

•

Experienced management team with significant

development, regulatory and commercial experience

Supplemental Financial Information

Non-GAAP Reconciliation

(in millions)

12 months

ended

Dec.

31, 2014

(audited)

3 months

ended

March 31,

2015

3 months

ended

March 31,

2014

Net income

$14.3

$1.8

$3.5

Income

tax expense

$3.3

$0.6

$0.8

Impairment of long-lived assets

$1.4

$0.0

Depreciation and amortization

$10.3

$2.9

$2.5

EBITDA

$29.2

$5.2

$6.8

The Company defines EBITDA as earnings before interest, taxes, depreciation and amortization. The

Company also presents EBITDA because it believes it is frequently used by securities analysts,

investors and other interested parties as a measure of financial performance. EBITDA has limitations as

an analytical tool, and when assessing the Company's operating performance, investors should not

consider EBITDA in isolation, or as a substitute for net income (loss) or other consolidated income

statement data prepared in accordance with U.S. GAAP.

Recro Pharma, Inc. - FORM 8-K - EX-99.2 - July 24, 2015

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