Recro Pharma, Inc. - FORM 8-K - EX-99.1

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8-K - 8-K - Recro Pharma, Inc.	d474247d8k.htm

October 2017

Relieving pain…….Improving lives

Exhibit 99.1

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, 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.

This presentation is intended to be nonpromotional and for investor discussion

purposes only. The information provided herein contains references to investigational

products and use of these products has not been approved by the FDA. The safety

and efficacy of the investigational use of these development products has not been

determined. There is no guarantee that the investigational use listed will be filed with

and/or approved for marketing by any regulatory agency. 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

•

Specialty pharmaceutical company focused on hospital and related settings with late stage investigational

product, IV Meloxicam, targeting management of moderate to severe pain

•

Filed New Drug Application for IV Meloxicam in July 2017; Received FDA acceptance for review in September

2017 (PDUFA Date-

May 26, 2018)

–

Reported results for pivotal Phase 3 trial in patients following abdominoplasty surgery

–

Reported results for pivotal Phase 3 trial in patients following bunionectomy surgery

–

Reported results for Phase 3 safety study demonstrating solid safety and tolerability profile

–

Completed renal impairment and ECG studies

•

Multiple therapeutics in clinical development for hospital and related settings

–

Non-opioid, alpha 2 agonist for peri-procedural use;

–

Recent acquisition of Neuromuscular Blockers (NMB) and related reversal agents from Cornell University

•

Used for rapid induction and reversal of neuromuscular blockade

•

Revenue and cash flow positive contract development and manufacturing (CDMO) business

–

Raised Revenue and EBITDA Guidance, August 2017

•

Solid cash position-

$50.2 million cash @ 6/30/17

•

Experienced management team with significant development, regulatory and commercial experience

Experienced Management and Board

•

Gerri

Henwood

–

President

and

CEO

Founded Recro Pharma (REPH, NASDAQ), Auxilium

Pharmaceuticals (AUXL, NASDAQ) and IBAH (former

NASDAQ

Co.

–

acquired

1998);

GSK

•

Michael

Celano

–

CFO

Over 35 years of financial leadership experience –

Kensey

Nash, BioRexis, Orasure, Arthur

Andersen/KPMG

•

Randy

Mack

–

SVP,

Development

Over

years

clinical

development

experience

–

Adolor,

Auxilium, Abbott Labs and Harris Labs

•

Stewart

McCallum,

–

CMO

Over

years

GSK

Clinical

experience

–

Development

experience; past clinical Investigator, KOL and Stanford U.

•

Fred

Graff

–

CCO

Over 30 years of successful commercial experience,

including sales and marketing leadership roles at Sepracor,

RPR, and MAP Pharmaceuticals

•

Scott

Rizzo-

General

Manager,

Gainesville

CDMO

Over 25 years of operations experience –

Roche

Pharmaceuticals, Barrier Therapeutics, PwC, E.I. DuPont

Board of Directors

Wayne

Weisman

–

Chairman

SCP VitaLife Partners

Alfred Altomari

CEO, Agile Therapeutics; former J&J

William L. Ashton

Harrison

Consulting

Group;

frmly

Amgen

Michael Berelowitz, M.D.

Former SVP, Specialty Care Business Unit,

Pfizer

Winston J. Churchill

SCP VitaLife Partners

Karen Flynn

Senior Vice President and Chief Commercial

Officer of West Pharmaceutical Services, Inc.

Gerri

Henwood

–

CEO

Bryan Reasons

SVP and CFO, Impax

Laboratories

Recro

Pharma: An Acute Care Company

(REPH:NASDAQ)

Contract Manufacturing

Acute Care Division

Our Two Divisions

Acute Care Clinical Stage Pipeline

Investigational Product

III

Rights

Meloxicam

IV formulation

Acute post operative pain

Filed NDA

IM formulation

Acute pain

Dexmedetomidine (“Dex”)

WW, exc. Europe, Turkey, CIS

Dex-IN (intranasal)

Peri-procedural pain

Phase 2

Cancer breakthrough pain

Neuromuscular Blockers (NMB)

(Anesthesia)

IV Intermed

–

action (RP1000)

IV Ultra-short action (RP2000)

NMB Reversal (Anesthesia)

RP3000

Post Op Pain Market Underserved

•

$5.9 billion market

(1)

•

Predominantly opioid

use

(1)

•

Significant side effects /

issues associated with

opioids

(2)

•

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.

(2)

Benyamin et al. 2008. “Opioid Complications and Side Effects.”

Pain Physician 11 (SPEC. ISS. 2): S105–20

Limited Acute Pain Relief Options for Patients

*Pain severity based upon market research / physician feedback

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

Alpha 2 agonists

Dexmedetomidine

(Recro Pharma)

Target pain relief; anxiolytic

properties; no respiratory

depression, impaired GI or

addictive properties

In development –

potential to be

approved for peri-procedural

pain; blood pressure decrease

Moderate to

Severe

Non-opioid,

once a day

preferential

COX-2

IV/IM meloxicam

(Recro Pharma)

q24 hour dosing;

Both Ph. 3 pivotal studies met

primary endpoints;

MOA-

no impact on GI

motility; well tolerated

Class effects: Bleeding risk; GI

and renal complications.

Opioids

Morphine,

hydrocodone,

oxycodone, fentanyl

Good pain relief

Respiratory depression, impaired

GI motility after even one dose;

frequent nausea and vomiting;

abuse/addiction potential

IV Meloxicam

IV Meloxicam Overview

•

FDA approved as an oral preferential COX-2 inhibitor and used in a number

of indications

•

Proprietary non-opioid, once daily injectable form for management of

moderate to severe pain

–

Incorporates Alkermes’ NanoCrystal

technology

•

IV Meloxicam –

once daily preferential COX-2 inhibitor for moderate to

severe acute pain

–

Multiple Phase 2 studies met primary endpoints in acute pain models

–

Phase 3 efficacy trial in abdominoplasty met the primary endpoint

–

Phase 3 efficacy trial in bunionectomy met the primary endpoint

–

Phase 3 safety study demonstrated solid safety and tolerability profile

–

Completed renal impairment and ECG studies

–

Filed New Drug Application in July 2017; Received FDA acceptance for review in

September 2017 (PDUFA Date-

May 26, 2018)

•

Formulation IP issued through 2022 and additional methods of preparation

IP issued through May 2030

NanoCrystal

is a registered trademark of APIL

Phase 3 Safety Study Reported Q2 2017

•

Randomized, Double-blind, Placebo-controlled Safety

Study

–

Subjects requiring major surgery that was expected to result in

inpatient hospitalization for at least 24-48 hours

•

721 subjects at 31 centers in 4 countries treated with:

–

Placebo

–

IV Meloxicam 30 mg

•

Study drug administration

–

Added to existing pain management protocol after surgery (No

minimum pain score required for randomization)

–

Once daily for up to 7 doses

–

Additional dose at discharge was at the discretion of subject and

investigator.

Phase 3 Safety Study-

Endpoints

•

Incidence of AEs and SAEs

•

Change from baseline in laboratory tests;

incidence of abnormal clinical laboratory tests

•

Change from baseline in vital signs; incidence of

clinically significant changes in vital signs

•

Incidence of clinically significant abnormal ECG

findings

•

Incidence of abnormal wound healing

•

Opioid consumption over 48 hours

Phase 3 Safety Study-

Subject Demographics

Overall

Variable

(N=721)

Mean (Range) Age (yrs)

53 (18-80)

>=65 years: n (%)

163 (22.6)

Male: n

(%)

293 (40.6)

Mean (SD) BMI (kg/m

)

29.4 (4.93)

>=35 kg/m

: n (%)

111 (15.4)

Surgery: n (%)

Abdominoplasty

43 (6.0)

Gynecologic Surgery

89 (12.3)

GI Surgery

39 (5.4)

Soft Tissue Surgery

170 (23.6)

Total Ankle Replacement

1 (0.1)

Total Shoulder Replacement

8 (1.1)

Total Hip Replacement

68 (9.4)

Total Knee Replacement

156 (21.6)

Orthropedic Trauma

1 (0.1)

Complex Foot

71 (9.8)

Bunionectomy

53 (7.4)

Spinal

13 (1.8)

Head And Neck

1 (0.1)

% of Subjects

IV Meloxicam

30 mg

Placebo

Adverse Event

N = 538

N = 183

Subjects with an SAE

2.6

5.5

Subjects with >=1 AE

63.0

65.0

Nausea

22.9

27.9

Constipation

9.5

9.3

Vomiting

5.0

7.7

Pruritis

3.9

5.5

GGT Increased

3.9

2.7

Headache

3.7

6.6

Anemia

3.3

2.2

Phase 3 Safety Study

Adverse Events –

3% in the IV Meloxicam Group

Phase 3 Safety Study

>65 years & Mild Renal Impairment

Adverse Events –

3% in the IV Meloxicam Group

n (%) of Subjects

IV Meloxicam

30 mg

Placebo

Adverse Event

N = 88

N = 31

Subjects with >=1 AE

Nausea

17 (19.3)

8 (25.8)

Constipation

16 (18.2)

Anemia

Vomiting

Pruritus

GGT increased

Pyrexia

Urinary Tract Infection

Postoperative Fever

Phase 3 Safety Study –

Total Population

Total Opioid Used (in morphine equivalents)

*p<0.05

22.0%

23.9%

33.9%

23.2%

0-24 HR

24-48 HR

48-72 HR

Treatment Period

IV Meloxicam 30 mg (n=538)

Placebo (n=183)

Phase 3 Safety Study –

Orthopedic Surgeries

Total Opioid Used (in morphine equivalents)

*p<0.05

27.4%

26.1%

38.4%

25.8%

0-24 HR

24-48 HR

48-72 HR

Treatment Period

IV Meloxicam 30 mg (n=283)

Placebo (n=96)

0-24 HR

24-48 HR

48-72 HR

Treatment Period

IV Meloxciam 30 mg (n=117)

Placebo (n=39)

Phase 3 Safety Study –

Total Knee Replacement

Total Opioid Used (in morphine equivalents)

36.4%

35.2%

*p<0.01

58.9%

38.4%

Phase 3 Safety Study

>65 years & Mild Renal Impairment

Total Opioid Used (in morphine equivalents)

*p<0.05

0-24 HR

24-48 HR

48-72 HR

Treatment Period

IV Meloxicam 30 mg (n=88)

Placebo (n=31)

30.5%

41.9%

56.9%

33.8%

Phase 3 Abdominoplasty Study

•

Multicenter, Multi-dose, Randomized, Double-blind,

Placebo-controlled

•

219 subjects randomized to IV Meloxicam 30mg or

Placebo

–

Study medication administered once daily up to 3 doses

–

98% of subjects completed the 48 hour assessments

•

Standard analgesia design

–

Pain Intensity assessments (SPID24 = Primary Endpoint)

–

Use of rescue medication

–

Time to onset

–

Patient Global Assessment of Pain Control

Phase 3 Abdominoplasty Study

Primary Endpoint –

SPID24*

* W2LOCF

Phase 3 Abdominoplasty Study

Summary of Secondary Endpoints

SPID6, Times to Meaningful Pain Relief and First Rescue, Number of

Subjects

rescued

0-24

and

0-48

hours,

Subjects

with

>30

and

>50%

Improvement

within

Hours

and

>50%

within

hours,

PGA

Pain

Control at 24 hours were not significantly different between treatment

groups.

Parameter

Met criteria for Statistical

Significance:

SPID12

SPID48

SPID24-48

Number of Subjects Rescued 24-48 Hours

Number of Times Rescued 0-24 Hours

Number of Times Rescued 24-48 Hours

Number of Times Rescued 0-48 Hours

Time to Perceptible Pain Relief

Subjects

with

>30%

Improvement

Hours

PGA of Pain Control at 48 hours

Phase 3 Abdominoplasty Study

Adverse Events –

2% in the IV Meloxicam group

n (%) of Subjects

IV Meloxicam

30 mg

Placebo

Preferred Term

(N=110)

(N=109)

Subjects with >=1 TEAE

58 (52.7)

80 (73.4)

Nausea

30 (27.3)

41 (37.6)

Headache

13 (11.8)

18 (16.5)

Vomiting

5 ( 4.5)

10 ( 9.2)

Dizziness

4 ( 3.6)

10 ( 9.2)

** Four (4) subjects experienced Serious Adverse Events during this

study. Three subjects were randomized to placebo and one to IV

Meloxicam.

Phase 3 Bunionectomy Study

•

Multicenter, Multi-dose, Randomized, Double-blind,

Placebo-controlled

•

201 subjects randomized to either IV Meloxicam 30 mg or

Placebo

–

Study medication administered once daily up to 3 doses

–

95% of subjects completed the 48 hour assessments

•

Standard analgesia design

–

Pain Intensity assessments (SPID48 = Primary Endpoint)

–

Use of rescue medication

–

Time to onset

–

Patient Global Assessment of Pain Control

Phase 3 Bunionectomy Study

Primary Endpoint –

SPID48*

* W2LOCF

Phase 3 Bunionectomy Study

Summary of Secondary Endpoints

Parameter

Met criteria for Statistical

Significance:

SPID6

SPID12

SPID24

SPID24-48

Time to First Rescue Analgesia

Number of Subjects Rescued 0-24 Hours

Number of Subjects Rescued 24-48 Hours

Number of Subjects Rescued 0-48 Hours

Number of Times Rescued 0-24 Hours

Number of Times Rescued 24-48 Hours

Number of Times Rescued 0-48 Hours

Subjects

with

>30%

Improvement

Hours

Subjects

with

>30%

Improvement

Hours

Subjects

with

>50%

Improvement

Hours

PGA of Pain Control at 48 hours

Times to Perceptible and Meaningful Pain Relief, % Subjects with

>50% Improvement within 6 Hours, PGA of Pain Control at 24

hours were not significantly different between treatment groups.

Phase 3 Bunionectomy Study

Adverse Events –

3% in either group

n (%) of Subjects

IV Meloxicam

30 mg

Placebo

Preferred Term

(N=100)

(N=101)

Subjects with

1 TEAE

44 (44.0)

54 (53.5)

Nausea

20 (20.0)

26 (25.7)

Headache

8 (8.0)

12 (11.9)

Vomiting

3 (3.0)

9 (8.9)

Pruritus

8 (8.0)

3 (3.0)

Decreased appetite

2 (2.0)

7 (6.9)

Constipation

4 (4.0)

5 (5.0)

Abdominal pain

6 (5.9)

Dizziness

3 (3.0)

4 (4.0)

Flushing

3 (3.0)

1 (1.0)

Somnolence

3 (3.0)

2 (2.0)

ALT increased

3 (3.0)

**Two (2) subjects experienced Serious Adverse Events during this

study. Both subjects were randomized to placebo.

Next Steps for IV Meloxicam

•

Filed NDA for IV Meloxicam in July 2017; Received FDA acceptance for

review in September 2017 (PDUFA Date-

May 26, 2018)

•

Total across NDA: approximately 1400 meloxicam patients

–

Largest Phase 3 double blind placebo controlled non-opioid study

evaluating post operative IV pain product in a post-operative setting

•

Finalize and initiate Phase 3B studies

–

Orthopedic surgery (total knee)-

opioid consumption/pain intensity

–

Colorectal surgery-opioid consumption; length of stay

•

Execute Commercialization and Launch Plan

–

Strategic Segmentation, Prioritization and Targeting to Accelerate Formulary

Adoption

Opioids Dominate the IV Pain Market

3.9

1.3

0.7

0.5

2.2

7.1

2.1

1.4

0.8

6.1

Opioids

Local Anesthetics

Ketorolac

Ofirmev

Any Drug

Number of Inpatients Treated & DOT For Top 10 Surgical Procedures Treated

With Selected IV Analgesics

Patients

Days Of Therapy

Note: Patients may be treated with more than one analgesic during a given DRG

Source: Truven Health Analytics 2014

Demonstrate clinical and economic

value versus IV opioids

Efficacy in Double Blind Laparoscopic Abdominal

Surgery compared to Ketorolac and to Placebo

*** p < 0.001 vs.

Placebo

CONFIDENTIAL

Peak Analgesic Effects of IV Meloxicam and

Morphine

Single 30mg Dose Performance over 24 hrs

(Abdominal

Hysterectomy

Trial

–

Meloxicam

Morphine)

Baseline Pain Level ~60

-10

Time (Hours)

Placebo n=64

Morphine n=62

IV Meloxicam 30 mg n=60

Length of Analgesic Effects of IV Meloxicam

and Morphine

34%

17%

94%

92%

61%

36%

32%

29%

88%

100%

95%

78%

75%

68%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0.5 hour

1 hour

6 hour

12 hour

18 hour

24 hour

Placebo

IV Morphine 0.15 mg/kg

IV Meloxicam 30 mg

Responder rate based on >30% improvement in pain intensity scores in moderate/severe patients

following open hysterectomy

Each medication given as a single dose

LOCF Analysis

Phase 2 Open Hysterectomy Study

IV Meloxicam Target Opportunity

Intra-abdominal Procedures

•

Surgeons have keen

interest in:

–

Avoidance of opioids

–

Avoidance of troughs in

existing non-opioid pain

med options

•

If approved, could answer

needs through:

–

Relief of moderate to

severe pain over 24 hours

–

Reducing LOS

Orthopedic Procedures

•

Surgeons have keen

interest in:

–

Long lasting serious pain

relief to get the patient

through the trip home and

first post-op day/night

–

Many surgeons concerned

about opioid use and

potential for addiction

•

If approved, could answer

needs through:

–

Relief of moderate to

severe pain over 24 hours

–

No addiction properties

Ambulatory Surgical Centers Offer Opportunity for High

Volume Surgeons To Gain Early Meloxicam Experience

Experience with IV Meloxicam:

Build market experience with IV Meloxicam at settings that

have lower barriers to adoption and appetite for

experimentation

Hospital Outpatient

Settings

Hospital Inpatient

Settings

Ambulatory

Surgical Center

Setting

High Performing Surgeons That Practice at All Locations

Early trials may carry back and drive adoption at Community

and Academic Hospitals

CONFIDENTIAL

Long-Lasting Opioid Sparing Option is Perceived

Important Across All Settings of Care

Segment

Size

Summary

ASC

~2.2M

Patients

Opioid

sparing

option

reduces

physician

risk,

facilitates

same

day

discharge

with improved patient experience and 24 hour pain control.

Expand surgery repertoire by enabling more complex surgeries to be

performed and discharged on the same day at ASCs.

Swift formulary decision-making

Healthy margin, limited by level of reimbursement per case

HOPD

~9M Patients

Opioid

sparing

option

reduces

physician

risk,

facilitates

on-time

early

discharge with improved patient experience and 24 hour pain control.

Healthy margin on average, burdened by hospital-wide pharmacy budget

Slow formulary decision-making, but shared across multiple settings

Inpatient

~11M

Patients

Opioid

sparing

option

with

hour

efficacy

remains

appealing

Reduction

length

stay

remains

important

but

less

compelling

because

benefit masked by operational efficiencies of the staff

Slow formulary decision-making, but shared across multiple settings

Greater institutional inertia to impact change

Source: Primary market research with customer interviews and analysis

Targeted Accounts Cover ~12.6M Patients

Across All Settings Of Care

Hospital Inpatient

HOPD

ASC

Total

Addressable

Procedures

11m

6.9m

2.2m

~29m

Core Target

Procedures

Targeted

Accounts

3.7m

0.5m

7.2m

1.2m

~12.6m

Patient opportunity

by setting of care

Source: Definitive HC (DRG and CPT#) –

Medicare; Projected to US All Payer @ 3.5X for ED, 4X for HOPD & ASC; Claims / Patient –

LexisNexis: ASC 3X; HOPD/ED 1.2

Notes:

•

Addressable DRGs exclude DRGs where Meloxicam may be inappropriate (e.g. ObGyn, cardiovascular); Core Target DRGs are high volume Ortho, GI, General Surgery procedures

•

ER procedures include many medical uses (e.g. back pain) where there is no surgical procedure; at launch ER utilization is considered spillover from other hospital settings

•

Addressable HOPD/ASC procedures exclude colonoscopies, eye procedures and focus on Ortho, GI and General Surgery procedures

nearly all addressable procedures are targeted

1,475 Hospitals

~570 ASCs

Orthopedic (Hip/Knee, Spine, other)

General Surgery

GI/Colorectal

SF Size Of 80-100 Reps Provides 80% Coverage Of Key

Procedures, Institutions, Key Surgeons & Top ASCs

Source: Definitive HC (2015-20161H)

80%

95%

1,475

Institutions

3.8M

Procedures

~570 ASC

~3.5m claims

~1.2m patients

Further ASC & IDN Data analysis in addition to pre-launch account profiling activity will

lead to refinements in ASC targeting

0.5

1.5

2.5

3.5

4.5

Concentration Curve For US

Hospitals, Procedure Volume

Concentration Curve For ASC,

Estimated All Payer Claim

Volume

Number of Hospitals

Number of ASCs

NMB

Compounds

from

Cornell

Background

•

NMBs

stands

for

Neuromuscular

Blocking

Agents:

(Used

“anesthetic” agent to facilitate intubation and surgery)

•

NMBs are classified by their onset time and duration of activity

* Predicted based on currently available data **supplemental

pre-clinical

work

required

before

clinical

trial

higher

dose

Compound

Onset Time

Duration of Activity

Status

Intermediate

Acting*

RP1000

Rapid*

Intermediate

Acting*

Phase

I**

Ultra-Short

Acting*

RP2000

Rapid*

Ultra-short

acting*

Pre

IND

•

Reversal agent specific to licensed compounds; acts quickly by a chemical

reaction to reverse blockade

•

Potential for same dose of reversal agent to be used independent of time of

administration

•

Reversal agent may require further refinement formulation

NMB –

What is the clinical need?

•

Novel NMBs and related agents with the potential for rapid onset with ultra-

short and intermediate durations of action, along with the potential to be

rapidly reversed

•

Clinical potential: reducing the time required for induction of anesthesia and

the time needed to recover from NMB that patients require post procedure

(in the OR and in the PACU) while potentially enhancing patient safety.

•

Current alternatives when patients need “reversing” from neuromuscular

blockade:

encapsulating/binding reversal agents (Sugammadex)

ii.

enzymatic reversal agents (Neostigmine)

–

Both pathways may require higher doses and therefore incur greater

expense if used earlier in a procedure compared to late in a procedure

•

(i.e., when more NMB agent is remaining in the patient’s system)

•

However, the proposed reversal agent used to reverse RP1000 and

RP2000, may more quickly reverse neuromuscular blockade via a chemical

reaction

–

This outcome could be beneficial to the patient and result in meaningful

cost savings for the hospital/ASC

Contract Development and Manufacturing (CDMO)

Business Overview

Gainesville

Gainesville CDMO Facility

Gainesville, GA, Facility

–

Located on 148 acres of land,

the facility has approximately

97,000 square feet of space

–

Plant began operations early 90’s

–

Includes 288 pallet vault built in

accordance with DEA

specifications

–

Operates under cGMP standards

–

Two level facility

–

FDA/EMA/DEA Licensed

–

Development, Scale-up and full

scale manufacturing

–

Manufactures product for U.S.,

European and Asian markets

–

Solid oral-dosage forms capacity

–

Capsule capacity-

500-700

million capsules

–

Tablet capacity-

1.5 billion

tablets

CDMO Overview

CDMO facility

•

97,000 + sq. ft. solid oral dosage manufacturing cGMP

•

DEA licensed;

~185

employees

•

Revenues include product

sales, royalties and profit

sharing

•

Positive cash flow providing debt service and non-dilutive

financing source for Company development and

operating activities

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

Verapamil/Verelan

•

CV/High blood pressure treatment

marketed by Teva

and

Lannett

Zohydro

•

Extended release hydrocodone marketed by Pernix

•

Launched

in 2014

•

Abuse deterrent form launched

Solid Oral Dosage Form Capabilities

•

Site currently configured to produce capsules at

commercial scale

•

Two commercial MG2 encapsulators each offering capacity

of 125mm doses

•

Capsule range of fill sizing 00 to 3

•

~400K/Hour Fette

tablet press

•

Coater in process

Commercial-scale Oral Dosage Capabilities

Development-scale Oral Dosage Capabilities

•

Capability to supply capsules and tablets at development-

and clinical-scale manufacturing

•

Bosch GKF-400 encapsulation machine

•

Korsch

XL100 Pro tablet press

2017 Additional Capabilities-Commercial Tablet

Press and Film Coating Equipment

Fette

FE55

LBB Bohle

BTC 100

Packaging Operations

•

One line operation with annual maximum

capacity of 2.5 million bottles per shift

•

Capability of packaging various size capsules

and tablets

•

Can handle round or square bottles 40cc –

500cc, and counts of up to 500 units/bottle

•

Met serialization requirements guidance early

Strong CDMO Business Performance

•

Revenues include product sales, royalties and profit sharing

–

2016 revenues included one-time revenues; customer ordering patterns are not always predictable

–

2017 Guidance-

Revenues of approximately $60-$63M, and EBITDA* of approximately $20-$23M

•

Additional capacity for new product opportunities

•

Positive cash flow for debt service obligations, as well as cash flow to contribute to the funding of

Company operating activities, including product development, and commercialization.

*EBITDA and Excess Cash Flow are non-GAAP financial measures (see reconciliation on last page of presentation)

CDMO Segment

($millions)

Year

Ended

December 31,

2016

(unaudited)

Six Months

Ended June

30, 2017

(unaudited)

Revenues

$69.3

$35.7

CDMO

Segment Operating

Income

$24.2

$10.3

EBITDA*

$31.8

$14.0

Excess

Cash

Flow

(before

interest

& principal payments)

$30.5

$11.9

Company Highlights

•

Specialty pharmaceutical company focused on hospital and related settings with late stage investigational

product, IV Meloxicam, targeting management of moderate to severe pain

•

Filed New Drug Application for IV Meloxicam in July 2017; Received FDA acceptance for review in September

2017 (PDUFA Date-

May 26, 2018)

–

Reported results for pivotal Phase 3 trial in patients following abdominoplasty surgery

–

Reported results for pivotal Phase 3 trial in patients following bunionectomy surgery

–

Reported results for Phase 3 safety study demonstrating solid safety and tolerability profile

–

Completed renal impairment and ECG studies

•

Multiple therapeutics in clinical development for hospital and related settings

–

Non-opioid, alpha 2 agonist for peri-procedural use;

–

Recent acquisition of Neuromuscular Blockers (NMB) and related reversal agents from Cornell University

•

Used for rapid induction and reversal of neuromuscular blockade

•

Revenue and cash flow positive contract development and manufacturing (CDMO) business

–

Raised Revenue and EBITDA Guidance, August 2017

•

Solid cash position-

$50.2 million cash @ 6/30/17

•

Experienced management team with significant development, regulatory and commercial experience

Reconciliation of Non-GAAP Financial Measures (unaudited)

CDMO Segment

($’s in millions)

2016

2017

Six

Months

2017

Estimate

Operating

Income

$24.2

$10.3

$12.6 -

$15.6

Depreciation

$5.0

$2.4

$4.8

Amortization of intangible

assets

$2.6

$1.3

$2.6

EBITDA

$31.8

$14.0

$20.0 -

$23.0

Capital expenditures

($4.3)

($2.5)

($4.8)

Change in working capital

$2.2

($0.1)

$1.8

Stock-based compensation expense

$0.8

$0.5

$1.0

Excess Cash

Flow (before

interest & principal payments)

$30.5

$11.9

$18.0 -

$21.0

To supplement our financial results determined by U.S. generally accepted accounting principles ("GAAP"), we have also

disclosed in the table below the following non-GAAP information for our Contract Development and Manufacturing

division (‘CDMO segment”): earnings before interest, taxes, depreciation and amortization ("EBITDA") and Excess Cash

Flow. We believe these non-GAAP financial measures are helpful in understanding our CDMO segment as such useful

to investors in allowing for greater transparency of supplemental information used by management. EBITDA is used by

investors, as well as management in assessing our performance. Under the credit agreement with our lender (OrbiMed),

Excess Cash Flow after interest paid on the OrbiMed

debt, is one of the metrics used to determine the amount that

OrbiMed

may require the Company to prepay on the outstanding principal on our loan on a quarterly basis (see Notes to

Financial Statements for description of the credit agreement). Excess Cash Flow is a useful measure of cash flow

available to not just service debt, but also use for other Company operating activities, including product development and

commercialization. Non-GAAP financial measures should be considered in addition to, but not as a substitute for,

reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the

same manner by all companies, and therefore should not be compared.

Appendix

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 and

eventual pre-

filled syringe

Ready to use IV

Dilution required,

30 min infusion

Ready to use,

min infusion

* IV Meloxicam clinical data from Study-04.

Multiple IV Phase 2 Trials

Trial

Design

Outcome

Phase 2 Study -

Acute pain following dental

surgery (N = 230)

Statistically significant differences for meloxicam

doses compared to placebo were seen in SPID24,

pain relief and onset of pain relief

Phase 2 Study -

Acute pain following open

abdominal hysterectomy

surgery (N = 486)

Statistically significant differences for meloxicam

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 2 Study -

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 2 Study

-014

Safety, Efficacy and PK in

Post-op bunionectomy

(N=59)

No serious AEs, no bleeding events

Efficacy-Statistically significantly reductions in pain

intensity as measured by SPID48 for 30 and 60

mg QD vs placebo

Attached files

Recro Pharma, Inc. Reports

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