Attached files
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| EX-99.1 - EX-99.1 - Recro Pharma, Inc. | d337732dex991.htm |
| 8-K - FORM 8-K - Recro Pharma, Inc. | d337732d8k.htm |
| Exhibit 99.2
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Exhibit 99.2
Relieving pain…….Improving lives
March 2017
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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. 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.
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Company Highlights
Specialty pharmaceutical company focused on hospital and related settings with first product, IV Meloxicam targeting post-operative pain Plan to file New Drug Application for IV Meloxicam in summer 2017
– Reported positive top-line results for pivotal Phase III trial in patients following abdominoplasty surgery
– Reported positive top-line results for pivotal Phase III trial in patients following bunionectomy surgery
– Completed renal impairment and ECG studies
– Completed enrollment of 700+ patients in safety trial; await completion of patient follow-up visits
Multiple non-opioid therapeutics in clinical development for pain conditions
Revenue and cash flow positive contract development and manufacturing (CDMO) business Solid cash position
– $64.5 million cash @ 12/31/16
– $40 million capital raise in December ($36.9 million net proceeds)
Experienced management team with significant development, regulatory and commercial experience
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Experienced Management and Board
Gerri Henwood – President and CEO
Founded 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 25 years of clinical development experience – Adolor, Auxilium, Abbott Labs and Harris Labs
Stewart McCallum, MD – CMO
Over 9 years of GSK Clinical experience – Development experience; past clinical Investigator, KOL and Stanford U.
Fred Graff – CCO
Over 20 years of successful commercial experience, including sales and marketing leadership roles at Sepracor, RPR, and MAP Pharmaceuticals
Board of Directors
Wayne B. Weisman – Chairman
SCP VitaLife Partners
Alfred Altomari
CEO, Agile Therapeutics
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
President-Pharmaceutical Packaging Systems, West Pharmaceutical Services, Inc.
Gerri Henwood – CEO Bryan Reasons
SVP and CFO, Impax Laboratories
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2015 Transformative Transaction
Acquired IV/IM Meloxicam and manufacturing business from Alkermes in April 2015
– $50M up-front cash payment plus working capital adjustment; Meloxicam milestones up to $125M (including, at our election, either (i) $10M payable upon NDA filing and $30M upon regulatory approval or (ii) an aggregate $45M upon regulatory approval, as well as other revenue target milestones), and royalties
– Warrants issued to Alkermes and OrbiMed
– Non-dilutive up-front financed by loan from OrbiMed o Paid down $22.7M, or 45% of the original $50M term loan from excess cash flow generated by the manufacturing business
IV Meloxicam – rapid onset, long acting preferential COX-2 inhibitor for moderate to severe acute pain
– Multiple Phase II studies successfully completed in acute pain models
– Phase III pivotal trial in hard tissue model reported positive efficacy data in July 2016
– Phase III pivotal trial in soft tissue model reported positive efficacy data in November 2016
– Completed renal impairment and ECG studies
– Completed enrollment of 700+ patients in safety trial; await completion of patient follow-up visits
– Advantages over existing acute pain therapeutics, including longer duration of action
Manufacturing business
– 97,000 sq. ft. facility (DEA licensed) manufactures 5 commercial products marketed by partners
– Revenues include product sales, royalties and profit sharing o 2016 revenues of $69.3M, and significant positive cash flow
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Acute Care Clinical Stage Pipeline
Product PC IIIIIIRights
Meloxicam WW
IV formulation
Acute post operative pain Phase III
IM formulation
Acute pain
Dexmedetomidine (“Dex”) WW, exc. Europe, Turkey, CIS
Dex-IN (intranasal)
Peri-procedural pain Phase II
Cancer breakthrough pain
Fadolmidine (“Fado”) WW, exc. Europe, Turkey, CIS
Intrathecal
Topical
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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.
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Limited Pain Relief Options for Patients
Pain
Severity Class CompoundsAdvantagesDisadvantages
Acetaminophen Antipyretic properties;Only effective for mild pain;
Oral; no opioid AEsshort acting
Mild
NSAIDs Ketorolac, ibuprofen,Mild to moderate analgesia;Bleeding risk; GI and renal
aspirinoral; no opioid AEscomplications; short acting
Sodium channel Use directly at pain site;Limited duration of action; some
Bupivacaine, lidocaineare concerned about local
blockers mostly peri-operativetissue impact
Moderate Good pain relief; anxiolytic
Dexmedetomidineproperties; no respiratoryIn development – potential for
Alpha 2 agonists first in class to be approved for
(Recro Pharma)depression, impaired GI orperi-procedural pain
addictive properties
Long-acting Long acting; fast onset, highClass effects: Bleeding risk; GI
IV/IM meloxicamand renal complications.
preferential pain relief, and less
(Recro Pharma)Meloxicam IV well tolerated to
COX-2 constipationdate.
Moderate to
Severe Respiratory depression,
Morphine,impaired GI motility after even
Opioids hydrocodone,Good pain reliefone dose; frequent nausea and
oxycodone, fentanylvomiting; abuse/addiction
potential
Note: Pain severity based upon market research / physician feedback
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IV Meloxicam Overview
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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’ NanoCrystalTM technology
IV Meloxicam – long acting preferential COX-2 inhibitor for moderate to severe acute pain
– Multiple Phase II studies successfully completed in acute pain models
– Positive Phase III efficacy trial in abdominoplasty
– Positive Phase III efficacy trial in bunionectomy
– Completed renal impairment and ECG studies
– Completed enrollment of 700+ patients in safety trial; await completion of patient follow-up visits spring: study results expected Q2
– Plan to file New Drug Application for IV Meloxicam summer 2017
Formulation IP issued through 2022 and additional methods of preparation IP issued through May 2030
NanoCrystal® is a registered trademark of Alkermes plc.
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Phase III Acute Postoperative Pain Studies
• Reported positive Phase III efficacy data in abdominoplasty surgery trial
– Placebo vs IV Meloxicam (30mg) every 24 hours
– Achieved statistical significance in primary endpoint (SPID24), as well as in 10 secondary endpoints
– Standard analgesia study design
• Reported positive Phase III efficacy data in bunionectomy surgery trial
– Placebo vs IV Meloxicam (30mg) every 24 hours
– Achieved statistical significance in primary endpoint (SPID48), as well as in 15 secondary endpoints
– Standard analgesia study design
• Completed renal impairment and ECG studies
• Completed enrollment of 700+ patients into Phase III safety study; await completion of patient follow-up.
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Phase III Abdominoplasty Study
• Multicenter, Multi-dose, Randomized, Double-blind, Placebo-controlled
• 219 subjects randomized to IV Meloxicam 30mg or Placebo
– Study medication administered q24 hours 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
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Phase III Abdominoplasty Study
Primary Endpoint – SPID24
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Phase III Abdominoplasty Study
Summary of Secondary Endpoints
Parameter p-value
SPID12 0.0434
SPID48 0.0040
SPID24-48 0.0028
Number of Subjects Rescued 24-48 Hours 0.0014
Number of Times Rescued 0-24 Hours0.0275
Number of Times Rescued 24-48 Hours0.0009
Number of Times Rescued 0-48 Hours0.0027
Time to Perceptible Pain Relief 0.0050
% Subjects with >30% Improvement—24 Hours 0.0178
PGA of Pain Control at 48 hours 0.0027
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 6 Hours and >50% within 24 hours, PGA of Pain Control at 24 hours were not significantly different between treatment groups.
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Phase III Abdominoplasty Study
Adverse Events – ³2% in the IV Meloxicam group
n (%) of Subjects
IV Meloxicam Placebo
30 mg
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.
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Phase III Bunionectomy Study
Multicenter, Multi-dose, Randomized, Double-blind, Placebo-controlled
201 subjects randomized to either IV Meloxicam 30 mg or Placebo
– Study medication administered q24 hours 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
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Phase III Bunionectomy Study
Primary Endpoint – SPID48
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Phase III Bunionectomy Study Summary of Secondary Endpoints
Parameter p-value
SPID6 0.0153
SPID12 0.0053
SPID24 0.0084
SPID24-48 0.0050
Time to First Rescue Analgesia 0.0076
Number of Subjects Rescued 0-24 Hours 0.0002
Number of Subjects Rescued 24-48 Hours 0.0009
Number of Subjects Rescued 0-48 Hours 0.0002
Number of Times Rescued 0-24 Hours 0.0025
Number of Times Rescued 24-48 Hours 0.0108
Number of Times Rescued 0-48 Hours 0.0014
% Subjects with >30% Improvement—6 Hours 0.0451
% Subjects with >30% Improvement—24 Hours 0.0107
% Subjects with >50% Improvement—24 Hours 0.0430
PGA of Pain Control at 48 hours 0.0046
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.
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Phase III Bunionectomy Study
Adverse Events – ³3% in either group
n (%) of Subjects
IV Meloxicam Placebo
30 mg
Preferred Term (N=100) (N=101)
Subjects with ³ 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.
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Next Steps for IV Meloxicam
• Complete safety study patient visits
– Completed enrollment of 700+ patients early; await completion of patient follow-up visits
• Total across all Phase III studies: estimated 1100 patients expected to be enrolled
• Plan to file NDA for IV Meloxicam in summer of 2017
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IV Meloxicam Target Opportunity
Intra-abdominal Procedures
• Surgeons have keen interest in:
– Avoidance of opioids
– Avoidance of peaks and troughs in existing non-opioid pain med options
• Meloxicam answers those needs through:
– Relief of moderate to severe pain over 24 hours
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
– Many surgeons concerned about opioid use and potential for addiction
• Meloxicam answers those needs through:
– Relief of moderate to severe pain over 24 hours
– No addiction risk
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Favorable Dosing Profile
CaldolorOfirmev
Attribute Meloxicam Ketorolac(ibuprofen)(APAP)
Route IV/IM IV/IMIVIV
Onset of pain
relief ~10 min* 30 minN/AN/A
Time to peak
analgesic effect ~40 min* 1-2 hrsN/AN/A
Duration of
pain relief 18-24 hrs 4-6 hrs4-6 hrs4-6 hrs
IV bolus and
Admin. eventual pre- Ready to use IVDilution required,Ready to use, 15
filled syringe 30 min infusionmin infusion
* IV Meloxicam clinical data from Study-04.
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IV Meloxicam Achieves Peak Analgesic Effect Comparable to Morphine
Single 30mg Dose Performance over 24 hrs
(Abdominal Hysterectomy Trial – IV Meloxicam vs IV Morphine)
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Baseline Pain Level ~60Placebo n=64
Morphine n=62
50
100) IV Meloxicam 30 mg n=60
-
(0
Baseline 40
from 30
Difference 20
Intensity 10
Pain 0
04812162024
-10
Time (Hours)
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IV Meloxicam Achieves Longer Lasting Analgesic Effect Than Morphine
Responder rate based on >30% improvement in pain intensity scores in moderate/severe patients
following open hysterectomy
100%
100% 94% 92%95%
90% 88%
80% 78%75%
68%
70% 61%
60%
50%
40% 34% 34%36%32%29%
30%
20% 17%
10% 9%8%8%
0%
0.5 hour 1 hour6 hour12 hour18 hour24 hour
PlaceboIV Morphine 0.15 mg/kgIV Meloxicam 30 mg
Each medication given as a single dose LOCF Analysis
Phase 2 Open Hysterectomy Study
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Number of Patients Requiring Opioid Analgesic Rescue Reduced Over 24 Hours with IV Meloxicam
Percent of moderate/severe pain patients requiring opioid analgesic rescue over 24 hours
following open hysterectomy
*P<0.001 vs. placebo
100% 95.3%
Rescue 90%
80% 77.4%*
70%
Analgesic 60%
50%
Opioid 40% 36.7%*
30%
Requiring 20%
10%
0%
Patients PlaceboIV Morphine 0.15 mg/kgIV Meloxicam 30 mg
n=64n=62n=60
Each medication given as a single dose
Phase 2 Open Hysterectomy Study
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Multiple Successful IV Phase 2 Trials
Trial Design Outcome
Phase II Study - Acute pain following dental Statistically significant differences for meloxicam
02 surgery (N = 230) doses compared to placebo were seen in SPID24,
pain relief and onset of pain relief
Phase II Study - Acute pain following open Statistically significant differences for meloxicam
04 abdominal hysterectomy doses compared to placebo were seen in multiple
surgery (N = 486) efficacy analyses, including SPID24. meloxicam
30 mg and 60 mg produced the greatest response
with no difference between doses
Phase II Study - Acute pain following Study stopped early (planned N = 250) for
05 laparoscopic abdominal business reasons. However, statistically
surgery (N =50) significant differences in SPID48 observed for
30mg QD dose despite small sample size
Phase II Study Safety, Efficacy and PK in Safety-well tolerated, no serious AEs, no bleeding
-014 Post-op bunionectomy events
(N=59) Efficacy-Statistically significantly reductions in pain
intensity as measured by SPID48 for 30 and 60
mg QD vs placebo
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Dexmedetomidine (“Dex”)
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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 peri-procedural pain
– In-licensed non-IV rights from Orion
– Worldwide rights except Europe, Turkey, and CIS
• Multiple studies demonstrate Dex pain relief and safety 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
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Positive Dex-IN Ph II Results
(REC-14-013 – Post Op Day 1 Dosing)
• Randomized, placebo controlled Phase II 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
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Fadolmidine (“Fado”)
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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
• WW rights to all human uses except Europe, Turkey and CIS
• NCE patent w/ expected extension to 2021
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Contract Development and Manufacturing (CDMO) Business Overview Gainesville
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Gainesville CDMO Facility
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CDMO Overview
97,000 + sq. ft. solid oral dosage manufacturing cGMP
DEA licensed; ~175 employees
Revenues include product sales, royalties and profit
CDMO facility sharing
Positive cash flow providing debt service and non-dilutive
financing source for Company development and
operating activities
Formulation, process development and optimization
Process scale-up
Service capabilities • 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 Teva and
Lannett
Extended release hydrocodone marketed by Pernix
Zohydro ER • Launched in 2014
Abuse deterrent form launched
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Strong CDMO Business Performance
Year Ended
CDMO Segment December 31, 2016
($millions) (unaudited)
Revenues $69.3
CDMO Segment Operating Income $24.2
EBITDA* $31.8
Excess Cash Flow * $30.5
Revenues include product sales, royalties and profit sharing
– 2016 revenues included one-time revenues; customer ordering patterns are not always predictable
– Expect recurring 2017 revenues of approximately $55-$60M, and EBITDA* of approximately $18-$20M
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)
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OrbiMed Debt Financing
• $50 million up-front payment funded via a five-year senior secured term loan with OrbiMed related to the Alkermes April 2015 transaction
– Interest at LIBOR + 14.0%, with a 1.0% LIBOR floor
– OrbiMed received warrants to purchase an aggregate of 3% of Recro’s outstanding common stock (on a fully diluted basis) as of the closing of the transaction.
• Paid down $22.7 million, or 45% of the original $50.0 million term loan from excess cash flow generated by the manufacturing business
– OrbiMed Loan @ 12/31/16- $27.3 million
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Company Highlights
• Specialty pharmaceutical company focused on hospital and related settings with first product, IV Meloxicam targeting post-operative pain
• Plan to file New Drug Application for IV Meloxicam in summer 2017
– Reported positive top-line results for pivotal Phase III trial in patients following abdominoplasty surgery
– Reported positive top-line results for pivotal Phase III trial in patients following bunionectomy surgery
– Completed renal impairment and ECG studies
– Completed enrollment of 700+ patients in safety trial; await completion of patient follow-up visits
• Multiple non-opioid therapeutics in clinical development for pain conditions
• Revenue and cash flow positive contract development and manufacturing (CDMO) business
• Solid cash position
– $64.5 million cash @ 12/31/16
– $40 million capital raise in December ($36.9 million net proceeds)
• Experienced management team with significant development, regulatory and commercial experience
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Reconciliation of Non-GAAP Financial Measures (unaudited)
To supplement our financial results determined by U.S. generally accepted accounting principles (“GAAP”), we have also disclosed in the table below the following non-GAAP information for our Contract Development and Manufacturing division (‘CDMO segment”): earnings before interest, taxes, depreciation and amortization (“EBITDA”) and Excess Cash Flow. We believe these non-GAAP financial measures are helpful in understanding our CDMO segment as such useful to investors in allowing for greater transparency of supplemental information used by management. EBITDA is used by investors, as well as management in assessing our performance. Under the credit agreement with our lender (OrbiMed), Excess Cash Flow is one of the metrics used to determine the amount that OrbiMed may require the Company to prepay on the outstanding principal on our loan on a quarterly basis (see Notes to Financial Statements for description of the credit agreement). Excess Cash Flow is a useful measure of cash flow available to not just service debt, but also use for other Company operating activities, including product development and commercialization. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.
CDMO Segment 2016 2017
($’s in millions) Estimate
Operating Income $24.2 $10.4- $12.4
Depreciation $5.0 $5.0
Amortization of intangible assets $2.6 $2.6
EBITDA $31.8 $18.0—$20.0
Capital expenditures ($4.3) ($4.9)
Change in working capital $2.2 $2.1
Stock-based compensation $0.8 $0.8
expense
Excess Cash Flow $30.5 $16.0-$18.0
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