Societal CDMO 8K Recro Pharma Reports First Quarter 2015 Financial Results | SCTL 12 May 15

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

information

currently

available

us,

and

assume

obligation

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

–

post interim analysis; top line expected mid-year ‘15

•

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 to Alkermes and OrbiMed

–

Non-dilutive up-front financed by loan from OrbiMed

•

IV/IM meloxicam –

long acting preferential COX-2 inhibitor for

moderate to severe acute pain ready for Ph III

–

Widely prescribed, approved oral chronic pain therapeutic

–

Multiple Phase II studies successfully completed in acute pain

models

–

Dosing advantages over existing acute pain txs, including long

action

•

Manufacturing, royalty and formulation business

–

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

products marketed by partners

–

$70M+ in revenues and cashflow positive (in 2014, unaudited)

Continuation of Ph II after Interim Analysis

(REC-14-013 –

Post Op Day 1 Dosing)

•

On-going Ph II bunionectomy study

–

Randomized, placebo controlled study

–

Primary endpoint –

SPID48

–

Rescue therapy allowed

•

Interim analysis for sample size adjustment

–

approximately half of the evaluable patients enrolled

•

Total enrollment reduced to approximately 170pts

–

Initially planned for 200 –

250pts

•

Top line results expected mid 2015

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

Ph II data expected mid-year ‘15

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

Note: Pain severity based upon market research / physician feedback

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

Sodium channel

blockers

Bupivacaine,

lidocaine

Use directly at pain

site; mostly peri-

operative

Limited duration of action; some are

concerned about local tissue impact

Opioids

Morphine,

hydrocodone,

oxycodone, fentanyl

Good pain relief

Respiratory depression, impaired GI

motility after even one dose;

frequent nausea and vomiting;

abuse/addiction potential

Mild

Moderate

Moderate to

Severe

Pain

Severity

Class

Compounds

Advantages

Disadvantages

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

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

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 II 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

is a registered trademark of 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,

15 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 –

IV 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

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

***

200

400

600

800

1000

1200

1400

***

Single 30 mg Dose Performance over 24 hrs

(Abdominal Hysterectomy Trial –

IV 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 –

IV 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 by Hospira in US as 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 9 trials

Trial

Form

Design

Outcome

REC-14-013

(On-going)

Dex-IN

Acute pain following

bunionectomy surgery

(estimated 170 pts)

Recent interim analysis for sample size

adjustment adjusted total trial enrollment

for 170 patients (initially planned for 200-

250)

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

bunionectomy

study

–

on-going

–

Randomized, placebo controlled study

–

Primary endpoint –

SPID48

–

Rescue therapy allowed

•

Post Op Day 1 dosing

–

Pain trajectory stable / declining

•

Interim analysis for sample size adjustment

–

Total enrollment reduced to approximately 170pts (initially

planned for 200 –

250pts)

•

Top line results expected mid-year 2015

Clinical Pipeline Intellectual Property

•

IV/IM meloxicam –

formulation IP 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) –

3 years (Meloxicam, Dex-IN, Dex-SL)

–

505(b)(1) –

NCE, 5 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 II analgesia study in 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 w/ expected extension to 2021 / pursuing add’l IP

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 XR

•

ADHD treatment marketed by Novartis

Verelan / verapamil

•

CV/High blood pressure treatment marketed by Actavis

and UCB

Zohydro ER

•

Extended release hydrocodone marketed by Pernix

•

Launched in 2014

•

Abuse deterrent form expected to be launched near term

Strong Historical Manufacturing Performance

•

Unaudited,

carve-out

financials

–

mos

ended

12/31/14

–

Revenues -

$73.6 million*

–

EBITDA -

$26.5 million*

•

Zohydro ER –

abuse deterrent form expected to be

launched in the near term

•

Additional capacity for new product opportunities

•

Positive cashflow expected to cover all debt service

obligations and excess cashflows to repay loan

principal

* Preliminary unaudited financial information. EBITDA is a non-GAAP financial metric. Please see

slide 35 for additional information including a reconciliation of Net Income to EBITDA.

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 in Ph II

–

post interim analysis; top line expected mid-year ‘15

•

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, unaudited, carve-out)

12 months ended

Dec. 31, 2014

Net income

$13.9

Income tax expense

Interest expense

$1.5

Depreciation and amortization

$11.0

EBITDA

$26.5

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

measure

financial

performance.

EBITDA

has

limitations

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.

The revenue and EBITDA data for the business acquired from Alkermes plc, are preliminary estimates

based solely upon information available to us as of the date hereof, and is not a comprehensive

statement of financial results or operating metrics for the acquired business for the year ended

December 31, 2014. The results for the acquired business for 2014 may differ materially from these

preliminary estimates. Accordingly, you should not place undue reliance upon these estimates.

Societal CDMO (SCTL) 8-KRecro Pharma Reports First Quarter 2015 Financial Results