UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2018
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-36329
Recro Pharma, Inc.
(Exact name of registrant as specified in its charter)
Pennsylvania
(State or other jurisdiction of
incorporation or organization)
490 Lapp Road, Malvern, Pennsylvania
(Address of principal executive offices)
26-1523233
(I.R.S. Employer
Identification No.)
19355
(Zip Code)
(484) 395-2470
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Common Stock, par value $0.01
Name of Exchange on Which Registered
Nasdaq Capital Market
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90
days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein, and will not be contained, to the
best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-
K. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company in Rule 12b-2 of the
Exchange Act.
Large accelerated filer
Non-accelerated filer
☐
☐
Accelerated filer
Smaller reporting company
Emerging growth company
☒
☒
☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
On the last business day of the most recently completed second fiscal quarter, the aggregate market value (based on the closing sale price of its common stock on that
date) of the voting stock held by non-affiliates of the registrant was $88.0 million.
As of February 15, 2019, there were 21,872,803 shares of common stock outstanding, par value $0.01 per share.
DOCUMENTS INCORPORATED BY REFERENCE
Part III of this Annual Report on Form 10-K incorporates certain information by reference from the registrant’s proxy statement for the 2019 annual meeting of
shareholders to be filed no later than 120 days after the end of the registrant’s fiscal year ended December 31, 2018.
TABLE OF CONTENTS
Index
Page
PART I
Item 1.
Business
Item 1A. Risk Factors
Item 1B.
Unresolved Staff Comments
Item 2.
Properties
Item 3.
Legal Proceedings
Item 4.
Mine Safety Disclosures
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Item 6.
Selected Financial Data
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 8.
Financial Statements and Supplementary Data
Item 9.
Changes in Disagreements with Accountants on Accounting and Financial Disclosures
Item 9A. Controls and Procedures
Item 9B.
Other Information
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
Item 11.
Executive Compensation
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13.
Certain Relationships and Related Transactions, and Director Independence
Item 14.
Principal Accounting Fees and Services
PART IV
Item 15.
Exhibits, Financial Statement Schedules
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FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K and the documents incorporated by reference herein contain forward-looking statements that
involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Annual Report on Form
10-K or the documents incorporated by reference herein regarding our strategy, future operations, future financial position, future
revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would” or the negative of such terms and similar
expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying
words. Such statements are based on assumptions and expectations that may not be realized and are inherently subject to risks, uncertainties
and other factors, many of which cannot be predicted with accuracy and some of which might not even be anticipated.
The forward-looking statements in this Annual Report on Form 10-K and the documents incorporated herein by reference include,
among other things, statements about:
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our estimates regarding expenses, future revenue, capital requirements and timing and availability of and the need for
additional financing;
our ability to resolve the deficiencies identified by the Food and Drug Administration, or FDA, in the complete response letter,
or CRL, for intravenous, or IV, meloxicam;
whether the FDA will approve our amended New Drug Application, or NDA for IV meloxicam and, if approved, the labeling
under any such approval that we may obtain;
if the FDA does not approve our amended NDA, the time frame otherwise associated with resolving the deficiencies identified
by the FDA in the CRL and whether the FDA will require additional clinical studies to support the approval of IV meloxicam
and the time and cost of such studies;
our ability to successfully commercialize IV meloxicam or our other product candidates, upon regulatory approval;
our ability to generate sales and other revenues from IV meloxicam or any of our other product candidates, once approved,
including setting an acceptable price for and obtaining adequate coverage and reimbursement of such products;
the results, timing and outcome of our clinical trials of IV meloxicam or our other product candidates, and any future clinical
and preclinical studies;
our ability to raise future financing and attain profitability for continued development of our business and our product
candidates and to meet required debt payments, and any milestone payments owing to Alkermes plc, or Alkermes, or our
other licensing and collaboration partners;
our ability to comply with the regulatory schemes applicable to our business and other regulatory developments in the United
States and foreign countries;
our ability to operate under increased leverage and associated lending covenants;
the performance of third-parties upon which we depend, including third-party contract research organizations, or CRO’s, and
third-party suppliers, manufacturers, group purchasing organizations, distributors and logistics providers;
our ability to obtain and maintain patent protection and defend our intellectual property rights against third-parties;
our ability to maintain our relationships, profitability and contracts with our key commercial partners;
our ability to defend the securities class action lawsuit filed against us, or any future material litigation filed against us;
our ability to recruit or retain key scientific, technical, commercial, and management personnel or to retain our executive
officers;
our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products,
including Good Manufacturing Practice, or cGMP, compliance and U.S. Drug Enforcement Agency, or DEA, compliance and
other relevant regulatory authorities; and
the effects of changes in our effective tax rate due to changes in the mix of earnings in countries with differing statutory tax
rates, changes in tax strategy, changes in the valuation of deferred tax assets and liabilities and changes in the tax laws.
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We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements
included in this Annual Report on Form 10-K, particularly under “Risk Factors,” that we believe could cause actual results or events to
differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of
any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments we may make.
You should read this Annual Report on Form 10-K and the documents that we incorporate by reference herein completely and with
the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to
update any forward-looking statements.
Solely for convenience, tradenames referred to in this Annual Report on Form 10-K appear without the ® symbol, but those
references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the
applicable owner will not assert its rights, to these tradenames. All trademarks, service marks and tradenames included or incorporated by
reference in this Annual Report on Form 10-K are the property of their respective owners, including, without limitation, the NanoCrystal®
mark owned by Alkermes and/or its affiliates.
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Item 1.
Business
Overview
PART I
We are a specialty pharmaceutical company that operates through two business segments: an Acute Care segment and a revenue-generating
contract development and manufacturing, or CDMO segment, through which we operate a revenue generating manufacturing business in
Gainesville, Georgia. We believe that we can bring valuable therapeutic options for patients, prescribers and payers, such as our lead
product candidate, injectable meloxicam, to the hospital and related acute care markets. We believe we can create value for our
shareholders through the development, registration and commercialization of injectable meloxicam and our other pipeline product
candidates, as well as through the ongoing contributions of our cash-flow positive CDMO segment. In addition to our pipeline, we continue
to evaluate acquisition, out-licensing and in-licensing opportunities.
Acute Care
Our Acute Care segment is primarily focused on developing and commercializing innovative products for hospital and related acute care
settings. Our lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV
meloxicam has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III
safety trial and other safety studies for the management of moderate to severe pain. Overall, the total new drug application, or NDA,
program included over 1,400 patients. In July 2017, we submitted an NDA to the Food and Drug Administration, or FDA, for IV
meloxicam for the management of moderate to severe pain. In May 2018, we received a Complete Response Letter, or CRL, from the FDA
regarding our NDA for IV meloxicam. In July 2018, we participated in a Type A End-of-Review meeting with the FDA to discuss the
topics covered in the CRL. In September 2018, we resubmitted the NDA for IV meloxicam and the FDA has set a date for decision on the
NDA under the Prescription Drug User Fee Act, or PDUFA, of March 24, 2019. We believe that IV meloxicam compares favorably to
competitive therapies in onset of pain relief, duration of pain relief, extent of pain relief and time to peak analgesic effect as well as that it
has been well tolerated. We believe injectable meloxicam, as a non-opioid product, will overcome many of the issues associated with
commonly prescribed opioid therapeutics, including respiratory depression, excessive nausea and vomiting, constipation, as well having no
addiction potential, while maintaining analgesic, or pain relieving, effects. We are pursuing a Section 505(b)(2) regulatory strategy for IV
meloxicam.
Our pipeline also includes other early-stage product candidates, including two novel neuromuscular blocking agents, or NMBAs, and a
related proprietary chemical reversal agent and Dex-IN, a proprietary intranasal formulation of dexmedetomidine, or Dex, an alpha-2
adrenergic agonist that we are evaluating for possible partnering.
Pipeline
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CDMO
Our CDMO segment leverages formulation expertise to develop and manufacture pharmaceutical products using proprietary delivery
technologies and know-how for partners who plan to develop and commercialize these products. These collaborations result in revenue
streams including manufacturing, royalties, profit sharing, and research and development, which support continued operations for our
CDMO segment and have contributed excess cash flow to be used for activities in our Acute Care segment. We operate a 97,000 square
foot, DEA-licensed manufacturing facility and a 24,000 square foot development and high potency facility, each in Gainesville, Georgia.
We currently manufacture the following key products with our commercial partners: Ritalin LA ®, Focalin XR®, Verelan PM®, Verelan
SR®, Verapamil PM, Verapamil SR and Zohydro ER®, as well as supporting multiple development stage products.
Our Strategy
We believe that we can bring valuable therapeutic options for patients, prescribers and payers, such as injectable meloxicam, to the hospital
and acute care markets. We believe we can create value for our shareholders through the development, registration and commercialization
of injectable meloxicam and our other pipeline product candidates as well as through the ongoing contributions of our cash-flow positive
CDMO segment. In addition to our pipeline, we evaluate acquisition and in-licensing opportunities, especially those that can contribute
additional revenue and cash flow. Our near-term goals include:
Complete regulatory approval of IV meloxicam. Our key 2019 goal is to receive FDA approval of IV meloxicam for the management of
moderate to severe pain. In September 2018, we resubmitted our NDA to the FDA for IV meloxicam for the management of moderate to
severe pain. The FDA accepted the resubmission for review and set a PDUFA date of March 24, 2019.
Expand data supporting benefits of IV meloxicam. We are currently evaluating IV meloxicam in a Phase IIIb program that includes clinical
trials in colorectal surgery patients and orthopedic surgery patients. We anticipate continuing the Phase IIIb program in 2019.
Commercialize IV meloxicam in the United States independently or with third-parties. We believe IV meloxicam targets a group of
specialists which would allow for successful marketing and commercialization by a company of our size. Assuming approval, we are
currently preparing for a U.S. commercial launch of IV meloxicam and are establishing sales management, marketing and reimbursement
functions to commercialize IV meloxicam in the United States.
Enter into strategic partnerships to maximize the potential of IV meloxicam and other product candidates outside of the United States. We
intend to pursue strategic collaborations with other pharmaceutical companies to develop and commercialize IV meloxicam outside of the
United States. We believe that our development expertise and unique product candidates make us an attractive partner to potential strategic
collaborators.
Leverage our development experience to progress our other pipeline product candidates. Our early-stage product pipeline includes
proprietary product candidates for use in anesthesia (neuromuscular blockade and reversal). Our goal is to leverage our drug development
expertise to develop these product candidates for use in hospital and acute care settings.
Expand our contract development and manufacturing business (CDMO). We are focused on the growth of our CDMO services. We intend
to seek additional product and related development partnerships through ongoing business development efforts, as well as possibly through
expansion of our proprietary drug delivery technologies, and current and new manufacturing service offerings.
Acute Care
Our Acute Care segment is primarily focused on developing innovative products for hospital and related acute care settings.
Our Lead Product Candidate - IV Meloxicam
Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory, and antipyretic activities. Our
proprietary injectable form of the drug, which utilizes NanoCrystal® technology, increases overall drug solubility which provides a faster
onset of action of meloxicam and provides a rapid treatment of acute pain, which lasts for approximately 24 hours.
Post-Operative Pain Market
Based upon information from the National Center for Health Statistics, it is estimated that there are over 100 million surgeries performed in
the United States each year. Of these surgeries, we believe at least 50 million procedures require post-operative pain medication.
Additionally, despite efforts to improve the provision of perioperative analgesia, the proportion of patients reporting moderate to severe
pain after surgery has remained constant over the past decade.
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While opioids provide effective analgesia for post-operative pain, their use is increasingly limited due to the known side effects of nausea,
vomiting, constipation, respiratory depression, the development of tolerance and the potential for impact on addiction, misuse and abuse.
Due to the potential for abuse, opioids are regulated as controlled substances and are listed on Schedule II and III by the DEA. According
to a January 2016 article in the New England Journal of Medicine, overdose deaths from prescription painkillers (defined to mean opioid or
narcotic pain relievers) increased significantly over the past 14 years and emergency department visits involved with misusing or abusing
prescription opioid painkillers increased 153% between 2004 and 2011. In the acute care setting, and according to the Joint Commission
Sentinel Event Alert on the Safe Use of Opioids in Hospitals, opioid analgesics rank among the drugs most frequently associated with
adverse drug events. As a result of the addictive potential and side effects, pain sufferers tend to limit their use of opioids, resulting in as
many as 40% of post-operative patients reporting inadequate pain relief. This can reduce the quality of life for individuals and, according to
an August 2012 article in the Journal of Pain, creates an economic burden estimated to be at least $560 to $635 billion a year in medical
costs and lost productivity.
Efforts to improve pain control with multimodal analgesia are being recommended by many medical societies as a way to decrease opioid-
related morbidity and mortality. Multimodal analgesia, or MMA, refers to the use of two or more drugs or nonpharmacologic interventions
with differing mechanisms. Its use has been demonstrated to limit the amount of opioids consumed and provide more effective pain control
than opioids alone. Effective MMA may further lessen the cost burden and personal toll of opioid-centric regimens. According to an April
2013 article in Pharmacotherapy, opioid-related adverse events negatively impact patients and the healthcare system and cause a 55%
longer length of hospital stay, 47% higher cost of care, 36% higher 30-day readmission rates and a 3.4% higher risk of inpatient mortality.
We believe that IV meloxicam offers an attractive alternative for relief of moderate to severe pain without the risks associated with opioids.
We also believe it can be an important part of an MMA approach for patients in the post-operative setting. Accordingly, we believe that
physicians, hospitals and third-party payers, including Integrated Delivery Systems (IDNs), Medicare and Medicaid, are interested in new
non-opioid pain therapies that provide effective post-operative pain relief without the adverse issues associated with opioids.
IV Meloxicam Advantages
We believe IV meloxicam has a number of advantages over existing analgesics, including the following:
Does not cause respiratory depression. Meloxicam does not cause respiratory depression. Besides the addictive nature of opioids, we
believe that medical practitioners are highly concerned with respiratory depression, which is a well-documented side effect of opioid use
(all opioids, including morphine, fentanyl and oxycodone). Respiratory depression, which is defined by inadequate ventilation leading to
increased carbon dioxide levels and respiratory acidosis, is an established outcome of opioid use and requires significant patient monitoring
in the acute care setting. One of the more concerning adverse effects of chronic opioid use, for which tolerance does not develop, is
respiratory depression during sleep, which can be life threatening. IV meloxicam has demonstrated through multiple clinical trials and
patient use that it does not cause respiratory depression.
Not a controlled substance. Meloxicam is not an opioid and not a controlled substance. Opioid therapeutics are currently controlled by the
DEA under the Controlled Substances Act. Under this act, opioids have been scheduled based on their potential for abuse and/or addiction.
For those opioids placed in Schedule II, federal law prohibits the refilling of prescriptions, thus requiring patients to request, and physicians
to write, additional prescriptions for each refill. Examples of Schedule II opioids include morphine, fentanyl, sufentanil, hydrocodone and
oxycodone.
Duration of pain relief. IV meloxicam has demonstrated the potential to be an effective analgesic for up to 24 hours after a single dose in
clinical trials. IV forms of ketorolac, ibuprofen and acetaminophen provide effective pain relief up to four to six hours, resulting in the need
for four to six doses per day.
Administration. We believe that IV meloxicam has an administration advantage in terms of being administered by bolus injection, whereas
ibuprofen and acetaminophen can take up to 15 to 30 minutes to be infused.
GI Tolerability. Unlike opioids, the mechanism of action of meloxicam provides analgesic activity with limited impact on gastrointestinal
motility thus limiting the common unwanted side effects of opioids, referred to as Opioid Induced Bowel Dysfunction, or OIBD. OIBD
comprises several symptoms including constipation, anorexia, nausea and vomiting, gastroesophageal reflux, delayed digestion, abdominal
pain, flatulence, bloating, hard stool, straining during bowel movement and incomplete evacuation.
Reduction of Opioid Consumption. Reducing opioid use inside and outside the hospital is becoming more of a priority for physicians and
hospital administrators. IV meloxicam has demonstrated the potential to relieve serious pain while reducing overall opioid
consumption. IV meloxicam also demonstrated a potential greater reduction in opioid use in patients over 65 years old with mild renal
impairment in clinical trials.
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Commercial Strategy
If IV meloxicam is approved by the FDA, we believe that it may have a positive value proposition based on our current clinical
data. Based on our market research, a new analgesic would be perceived to have a strong value proposition if it can: (1) reduce opioid
consumption, (2) allow ambulatory surgical centers to perform more complex procedures and discharge patients on the same day, and (3)
allow hospitals to safely speed up patient discharge, reduce inpatient admission and/or length of stay.
If IV meloxicam is approved by the FDA, we are hoping to generate early commercial experience with IV meloxicam at settings that have
lower barriers to new product adoption and have an appetite for use of newer therapies. To accomplish this goal, we believe it is important
to educate surgeons (e.g., orthopedic, colorectal and general) and anesthesiologists that practice at multiple settings of care within the acute
care market, including ambulatory surgical centers, or ASCs, hospital outpatient departments, and hospitals (often referred to as the
“hospital inpatient setting”). We believe that ASCs may have lower barriers to adoption and be willing to consider newer therapies during
our launch phase, based on our market research in this sector. We also believe early success in commercializing IV meloxicam with ASC’s
could lead to increased adoption of IV meloxicam in hospital outpatient settings, and ultimately hospital inpatient settings.
Overall, we plan to initially target approximately 1,500 hospitals and associated hospital outpatient departments, or HOPDs, and 600 ASCs,
which together represent approximately 12.6 million patients across all settings of care. If IV meloxicam is approved by the FDA, we plan
to build a sales force with approximately 80 to 100 representatives who would market IV meloxicam to health care professionals at our
called-on institutions. In addition, we have medical, account-based and reimbursement teams. We believe this focused approach will help
educate health care professionals, support formulary review processes and generate early adoption after launch with surgeons and
anesthesiologists.
Clinical Development
Multiple clinical trials have been conducted to evaluate the safety, pharmacokinetics and analgesic effect of IV meloxicam. Based on the
results of these trials, we believe IV meloxicam has the potential to be a potent analgesic used in the management of moderate to severe
pain. IV meloxicam has successfully completed two pivotal Phase III clinical trials, a large double-blind Phase III safety trial as well as
four Phase II trials and additional pharmacokinetics/safety studies. Overall, we enrolled a total of approximately 1,400 patients in our Phase
II/III programs. In addition, we are currently evaluating IV meloxicam in Phase IIIb clinical trials in colorectal surgery patients and
orthopedic surgery patients. Per the Pediatric Study Plan Agreement with FDA, two clinical trials will be conducted in the pediatric
population. These trials will be initiated following NDA approval of IV meloxicam and after appropriate regulatory and institutional review
board, or IRB, review.
At the end of July 2017, we submitted an NDA to the FDA for IV meloxicam 30mg for the management of moderate to severe pain. In
May 2018, we received a Complete Response Letter, or CRL, from the FDA regarding our NDA for IV meloxicam, which stated that the
FDA determined it could not approve the NDA in its present form. The CRL stated that data from ad hoc analyses and selective secondary
endpoints suggest that the analgesic effect did not meet the expectations of the FDA. In addition, the CRL identified certain CMC related
questions on extractable and leachable data provided in the NDA. The CRL did not identify any issues relating to the safety of IV
meloxicam. In July 2018, we participated in a Type A End-of-Review meeting with the FDA to discuss the topics covered in the CRL, and
we resubmitted the NDA for IV meloxicam in September 2018. The FDA has set a PDUFA date of March 24, 2019.
Phase IIIb Clinical Trials
We are currently evaluating IV meloxicam in a Phase IIIb program that includes clinical trials in colorectal surgery patients and orthopedic
surgery patients to assess opioid consumption, pain intensity and length of hospital stay with associated pharmacoeconomic
parameters. We anticipate continuing the Phase IIIb program in 2019.
Phase III Clinical Trials
Study REC-15-016
In this pivotal clinical trial, evaluating pain relief over a 48-hour period in a hard tissue, post-operative pain model (bunionectomy), IV
meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference, or SPID, over the
first 48 hours, or SPID48, compared to placebo. This was a Phase III, randomized, multicenter, multi-dose, double-blind, placebo-
controlled study evaluating IV meloxicam in the management of post-operative pain following bunionectomy surgery. Two hundred and
one patients who met the eligibility criteria were randomized to receive either IV meloxicam (30 mg) or placebo once daily for up to three
days. Following the beginning of treatment, patients remained under observation for 48 hours at study centers. Patients were followed for
28 days after the initial dose of study medication. There was an oral opioid rescue treatment available to all patients, if required. The
primary objective of the trial was to evaluate pain relief over a 48-hour period of IV meloxicam when administered as a bolus injection.
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The primary efficacy endpoint of the trial was SPID48, utilizing a windowed 2-hour last observation carried forward, or W2LOCF,
analysis method. Secondary efficacy endpoints included use of opioid rescue medication, SPIDs over various time intervals, and patient
global assessment, or PGA, of pain control. The IV meloxicam treatment arm demonstrated a statistically significant reduction in SPID48
(p=0.0034) compared to the placebo arm (Figure 1).
Figure 1: SPID48
The study also achieved the majority of secondary endpoints, including statistically significant differences in SPID6 (p=0.0153), SPID12
(p=0.0053), SPID24 (p=0.0084), SPID24-48 (p=0.0050), time to first use of rescue medication (p=0.0076), and several other rescue use
and pain relief metrics during the first 48 hours, compared to placebo. Times to Perceptible and Meaningful Pain Relief, % Subjects with
>50% Improvement within 6 Hours, and PGA of Pain Control at 24 hours were not significantly different between treatment groups.
The safety results demonstrated that IV meloxicam was well tolerated with no serious adverse events, or SAEs, or bleeding events in the
IV meloxicam-treated patients. The most common adverse events, or AEs, occurring in at least 3% of IV meloxicam-treated patients, were
nausea, headache, pruritus, constipation, vomiting, dizziness, flushing and somnolence, and the incidence of these AEs was generally
comparable to the placebo group. The IV meloxicam-treated patients experienced injection site pain and injection site erythema at a rate
comparable to placebo. The majority of treatment emergent AEs, or TEAEs, were mild in nature and there were no discontinuations due to
AEs. There were no meaningful differences between treatment groups in vital signs, electrocardiogram, or ECGs, or clinical lab
assessments.
Study REC-15-015
In the second of our two Phase III pivotal clinical trials, evaluating pain relief over a 24-hour period in a soft tissue, post-operative pain
model (abdominoplasty), IV meloxicam achieved the primary endpoint of a statistically significant difference in SPID over the first 24
hours, or SPID24, compared to placebo. This was a Phase III, randomized, multicenter, multi-dose, double-blind, placebo-controlled study
evaluating IV meloxicam in the management of post-operative pain following abdominoplasty surgery. Two hundred nineteen patients who
met the eligibility criteria were randomized to receive either IV meloxicam (30 mg) or placebo once daily for up to three days. Following
the beginning of treatment, patients remained under observation for 48 hours at study centers. Patients were followed for 28 days after the
initial dose of study medication. There was an oral opioid rescue treatment available to all patients, if required. The primary objective of the
trial was to evaluate pain relief over a 24-hour period of IV meloxicam when administered as a bolus injection (over 15-30 seconds).
The primary efficacy endpoint of the trial was SPID24 (0-24), utilizing a W2LOCF analysis method. Secondary efficacy endpoints
included use of opioid rescue medication, SPIDs over various time intervals, time to pain relief and PGA of pain control. The IV
meloxicam treatment arm demonstrated a statistically significant reduction in SPID24 (p=0.0145) compared to the placebo arm (Figure 2).
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Figure 2: SPID24
The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12
(p=0.0434), time to perceptible pain relief (p=0.0050), subjects with ≥30% improvement at 24 hours (p=0.0178), number of times patients
required rescue in the first 24 hours after randomization (p=0.0275), as well as number of times rescued from 24 to 48 hours (p=0.0009),
and several other pain relief metrics, compared to placebo.
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, and PGA of Pain Control at 24 hours were not significantly different
between treatment groups.
The safety results demonstrated that IV meloxicam was well tolerated with no difference in SAEs related to bleeding for IV meloxicam
treated patients versus placebo (1 each). There were two additional SAEs observed in the placebo group. The most common (at least 3% in
the IV meloxicam group) AEs were nausea, headache, vomiting, and dizziness. The incidence of these events was lower than those
observed in the placebo group. The majority of AEs were mild in nature and one patient in the placebo group discontinued treatment due to
an adverse event of post-procedural bleeding. There were no meaningful differences between treatment groups in vital signs, ECGs or
clinical lab assessments.
Safety Study
IV meloxicam has also successfully completed a double-blind, randomized Phase III safety study evaluating IV meloxicam (30mg bolus
injection) or placebo following major surgery. The primary objective of the study was to evaluate the safety and tolerability of IV
meloxicam 30mg vs. placebo through Day 28 following treatment. The clinical trial demonstrated that the adverse event profile of IV
meloxicam 30mg was consistent with previously completed clinical trials and was similar to placebo reported events.
This was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial and included patients who had undergone
major elective surgical procedures which were expected to result in hospitalization for at least 24-48 hours. Major surgical procedures
included total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries, as well as a range of other surgeries. Patient
demographics were balanced across treatment groups and included 40% male patients and about 23% of patients who were over age 65.
Unlike the pivotal efficacy trials, minimum pain scores were not required for treatment. Sites were permitted to use opioids and other pain
management modes according to their “standard of care” and meloxicam or placebo was added to this regimen in a randomized, double-
blind manner. Patients were randomized in a 3:1 ratio to receive either IV meloxicam 30mg or IV placebo daily for up to 7 doses. A total of
721 patients received at least one dose of study medication.
10
The most common (≥3%) AEs observed in the IV meloxicam 30mg treatment group (n=538) are listed in the table below:
Preferred Term
Subjects with ≥1 AE
Nausea
Constipation
Vomiting
Pruritis
Gamma-glutamyl transferase (GGT) increased
Headache
Anemia
IV Meloxicam
30 mg
N = 538
Placebo
N = 183
339 (63.0)
123 (22.9)
51 (9.5)
27 (5.0)
21 (3.9)
21 (3.9)
20 (3.7)
18 (3.3)
119 (65.0)
51 (27.9)
17 (9.3)
14 (7.7)
10 (5.5)
5 (2.7)
12 (6.6)
4 (2.2)
In patients age 65 and over, the percentage of patients reporting at least one AE was approximately 7% less in the IV meloxicam 30mg
treatment arm compared to the placebo arm. The total occurrence of patients with at least one SAE was observed to be lower in the IV
meloxicam 30mg group, 2.6%, than in the placebo group, 5.5%. In this safety study only two SAE events were listed as possibly related to
study treatment. Both of these SAEs occurred in one placebo treated patient. No deaths were reported in either treatment group.
Approximately 3% of patients in each study group discontinued.
There were no meaningful clinical differences between treatment groups in vital signs, ECGs, clinical lab assessments and surgeon
satisfaction with wound healing. Overall there was low incidence of clinically significant wound healing abnormalities, as scored by the
primary investigator, in both treatment groups (~2%). The meloxicam group had 4/538 patients with more than one attribute scored
“clinically significant”, while in placebo, 1/183 patients were scored “clinically significant” for only one attribute.
In addition, mean opioid consumption for the total population was lower in the IV meloxicam 30mg group compared with placebo at all
evaluated intervals; Hour 0-24, Hour 24-48, Hour 48-72 and Hour 0-72 intervals, or the full treatment period. There was also a significant
increase in time to first use of opioids in the IV meloxicam 30mg treatment arm, compared to placebo. Mean opioid consumption in the IV
meloxicam group was lower than the placebo group at all evaluated intervals in the subgroups of Orthopedic Surgeries, Total Knee
Replacements, and subjects >65 years with Mild Renal Impairment, as depicted in the table below.
% reduction in Opioid Use
Population
Total Population
Orthopedic Surgeries
Total Knee Replacement Surgeries
>65 years & Mild Renal Impairment Population
*reaching statistical significance (p<0.05)
**reaching statistical significance (p<0.01)
Our Other Pipeline Candidates
Hour 0-24 Hour 24-48 Hour 48-72
33.9%
23.0%
38.4%
25.5%*
58.9% 40.8%**
35.2%**
56.9%
41.9%*
23.2%*
28.9%*
41.0%**
42.8%*
40.7%*
Treatment
Period
23.6%
26.8%*
While our current priority is the commercialization of IV meloxicam, our pipeline also includes other earlier stage product candidates
including intermediate and short-acting NMBAs, and accompanying reversal agents, DEX-IN, along with other product candidates that we
may choose to develop for use in hospital or related settings.
11
NMBAs
Neuromuscular blocking agents are used as muscle paralyzing agents to facilitate intubation and surgery. We are developing an
intermediate-acting NMBA, RP1000, an ultrashort-acting NMBA, RP2000, and a reversal agent specific to our NMBAs. The table below
summarizes the predicted onset and duration of activity for each NMBA based on currently available data, as well as the development
status of each NMBA:
Compound
Onset Time
Duration of Activity
RP1000
RP2000
Rapid
Rapid
Intermediate acting
Ultra-short acting
Pre-clinical
Status
Phase I
In animal models, the proprietary reversal agent acts quickly by chemical reaction to reverse the neuromuscular blockade. We believe that
the NMBAs can reduce the time required for induction of anesthesia and the reversal agent can reduce the time needed to recover from
NMBA dosing post-procedure, while potentially enhancing patient safety and resulting in cost savings for the hospital or other provider.
RP1000, the intermediate-acting NMBA, and the reversal agent were subject to a clinical hold imposed by the FDA due to need for
additional toxicity data at higher dose exposures. We have met with the FDA and the clinical hold has been lifted with respect to RP1000.
We continue to work with the FDA regarding a path forward for the reversal agent. We expect to submit a new IND for RP1000 in 2019.
We have a worldwide, exclusive license to the NMBAs and the related reversal agent from Cornell University.
Dex-IN
Dex (dexmedetomidine) is a selective alpha-2 adrenergic agonist that has demonstrated sedative, analgesic and anxiolytic properties. Dex
has an extensive commercial history of safe IV use. We have formulated Dex-IN, a proprietary intranasal formulation of Dex, at a
significantly lower dose (approximately as low as 1/10th) than the currently recommended IV dosage levels used for clinical sedation.
Based upon our lower dose, we have seen minimal sedation to date in our clinical trials while still demonstrating an analgesic effect.
We continue to explore possible uses of Dex-IN in other indications in the Acute Care space as well as pursue possible partnering
opportunities.
CDMO Segment
Through our contract development and manufacturing, CDMO, segment, we leverage our formulation and development expertise to
develop and manufacture pharmaceutical products using proprietary delivery technologies and know-how for commercial partners who
commercialize or plan to commercialize these products. Our manufacturing and development capabilities include formulation, product
development from formulation through commercial manufacturing, and specialized capabilities for solid oral dosage forms, extended
release and controlled substance manufacturing, as well as high potency development and manufacturing. In a typical collaboration, we
work with our commercial partners to develop product candidates, or new formulations of existing product candidates, and may license
certain intellectual property to such commercial partners. We also typically exclusively manufacture and supply clinical and commercial
supplies of these proprietary products and product candidates. These collaborations may result in revenue streams including from
manufacturing, royalties, profit sharing, and research and development, which support continued operations for our CDMO segment as well
as provide free cash flow to support research and development of proprietary product candidates in our Acute Care segment.
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The table below details the key products developed and/or manufactured with our key commercial partners:
Product
Indication
Territory
Revenue
Source
Commercial
Partner
Agreement term
Ritalin LA®
Focalin XR®
Attention
Deficit
Hyperactivity
Disorder
Attention
Deficit
Hyperactivity
Disorder
Worldwide
Manufacturing
Novartis Pharma AG
Through December 31,
2023
Worldwide,
except Canada
Manufacturing
Novartis Pharma AG
Through December 31,
2023
Verelan PM®, SR &
Verapamil PM
Hypertension United States
Profit Sharing
/ Manufacturing
Lannett Company,
Inc.
Through December 31,
2021
Verapamil SR
Hypertension United States
Profit Sharing /
Manufacturing
Teva Pharmaceutical
Industries Ltd.
Annual renewals on a
calendar year basis
Zohydro ER®
Severe Pain
United States
Royalty /
Manufacturing
Pernix Therapeutics,
Inc.
Through March 2029
In addition to these key products, we also develop and manufacture other development stage products. The manufacture of these products
for clinical trials and commercial use is subject to cGMPs and other regulatory agency regulations. We own and operate a 97,000 square
foot, DEA-licensed manufacturing facility in Gainesville, Georgia, which has been inspected by U.S., EU, Turkish and Brazilian regulatory
authorities for compliance with required cGMP standards for continued commercial manufacturing and lease a 24,000 square foot
development and high potency facility, also in Gainesville, Georgia.
With each product, we either purchase active drug substance from third parties or receive it from our partners to formulate product using
our technologies. Although some materials for our products are currently available from a single source or a limited number of qualified
sources, we attempt to acquire an adequate inventory of such materials, establish alternative sources and/or negotiate long-term supply
arrangements. We do not currently have any significant issues finding suppliers. However, there is no certainty that we will be able to
obtain long-term supplies of our manufacturing materials in the future.
On February 8, 2019, we entered into new five-year manufacturing and supply agreement with Novartis Pharma AG, referred to as the
2019 Novartis Agreement . Under the terms of the 2019 Novartis Agreement, we will continue to be the exclusive supplier to Novartis of
Ritalin LA and Focalin XR through December 31, 2023. We previously supplied Ritalin LA and Focalin XR through two separate supply
agreements, which included two revenue components, product manufacturing revenue and royalty revenue; the 2019 Novartis Agreement
combines the supply of Ritalin LA and Focalin XR into one agreement, which provides product manufacturing revenue that is expected to
provide similar total revenue per capsule economics as did the two prior revenue components combined.
Permits and Regulatory Approvals
We hold various licenses for our CDMO segment manufacturing activities. The primary licenses held are FDA Registrations of Drug
Establishments and DEA Controlled Substance Registration. Due to certain U.S. state law requirements, we also hold certain state licenses
for distribution activities throughout certain states. We also hold cGMP certifications for EU importation of products made in Gainesville
for sale in the EU and an ANVISA certification for sale in Brazil.
In certain of our commercial partnerships, our commercial partner is the product authorization holder for products that have been
developed on behalf of the commercial partner. In other commercial partnerships, we are the authorization holder. When our commercial
partner holds the relevant authorization from the FDA or other national regulator, we support this authorization by furnishing a letter of
reference to the Drug Master File, or the chemistry, manufacturing and related data to the relevant regulator or sponsor to provide adequate
manufacturing support in respect of the product. We generally update this information annually with the relevant regulator.
We hold the approved NDAs for Verelan and Verapamil, which we license to Lanett Company, Inc. and Teva Pharmaceutical Industries,
Inc., respectively.
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Customer Agreements
We are party to agreements with each of our commercial partners governing the development, formulation and/or supply services we
provide, as well as any applicable intellectual property licenses. Each commercial partner generally remains responsible for distributing,
marketing and promoting their respective products. These collaborations result in revenue streams including royalties, profit sharing, etc.,
which support continued operations for our CDMO segment and have contributed funds to be used in our research and development and
pre-commercialization activities in our Acute Care segment. We are dependent on a small number of commercial partners, with our four
largest customers (Novartis Pharma AG, Teva Pharmaceutical Industries, Inc., Pernix Therapeutics, Inc., or Pernix, and Lannett Company,
Inc.) having generated 99% of our revenues for the twelve months ended December 31, 2018, of which Teva Pharmaceutical Industries,
Inc. generated 48% of our revenue under one customer agreement, and Novartis Pharma AG, generated 38% of our revenue combined
under two separate customer agreements, which effective January 1, 2019 is combined into one agreement.
Intellectual Property
Acute Care
We own patents and patent applications for injectable meloxicam, that cover compositions, including compositions produced using
NanoCrystal® technology, method of making and method of treating. These issued patents expire in 2022 in the United States. We also in-
license from Alkermes, on a perpetual, royalty-free basis, composition and methods of making patents, one of which we anticipate to be
Orange-Book listable, and patent applications (specifically directed to the prevention of flake like aggregates), which expire in 2030.
We license the patents and other intellectual property covering the NMBAs and the related reversal agent under a worldwide, exclusive,
sublicensable, royalty-bearing license from Cornell University. Under the license agreement, we are obligated to pay Cornell University (i)
an annual license maintenance fee payment until the first commercial sale of a licensed compound; (ii) milestone payments upon the
achievement of certain milestones, up to a maximum, for each NMBA, of $5 million for U.S. regulatory approval and commercialization
milestones and $3 million for European regulatory approval and commercialization milestones; and (iii) royalties on net sales of the
NMBAs and the related reversal agent at rates ranging from low to mid-single digits, depending on the applicable licensed compound and
whether there is a valid patent claim in the applicable country, subject to an annual minimum royalty amount. In addition, we will
reimburse Cornell University for past and ongoing patent costs related to prosecution and maintenance of the patents related to the licensed
compounds. The license agreement is terminable by us at any time upon 90 days’ written notice and by Cornell University upon our
material breach, subject to a cure period, and upon our filing any claim asserting the invalidity of any of Cornell University’s licensed
patent rights. The royalty term for each licensed compound expires, on a country-by-country basis, on the later of (i) the expiration date of
the longest-lived licensed patent, (ii) the expiration of any granted statutory period of marketing exclusivity, or (iii) the first commercial
sale of a generic equivalent of the applicable licensed compound. On the last to expire royalty term the license agreement will
automatically convert to a royalty-free nonexclusive license.
We hold patent applications directed to the analgesia indication, formulations and intranasal and transmucosal methods of use of Dex, and
we are progressing through the patent application process globally, including the United States. Several patent applications have issued as
patents outside the United States for transmucosal methods, and the resulting patent protection will last into 2030, subject to any
disclaimers or extensions. In addition, a patent related to intranasal methods has issued in the United States, and the resulting patent
protection will last into 2032, subject to any disclaimers or extensions.
We are party to an exclusive license with Orion for the development and commercialization of Dex for use in the treatment of pain in
humans in any dosage form for transdermal, transmucosal (including sublingual and intranasal), topical, enteral or pulmonary (inhalational)
delivery, but specifically excluding delivery vehicles for administration by injection or infusion, worldwide, except for Europe, Turkey, and
the CIS (currently includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan,
Ukraine and Uzbekistan), referred to herein as the Territory. We have the right to sublicense the rights under such license at any time. We
are required to pay Orion lump sum payments on the achievement of certain developmental milestones and upon the achievement of
certain commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 20% depending on annual sales
levels.
CDMO Segment
We own various controlled release formulation patents, including patents in the United States, Canada, Europe, and Brazil, related to our
proprietary delivery technologies that we utilize in our drug development, formulation and manufacturing business through our CDMO
segment. These patents are scheduled to expire between 2019 and 2026. We own patents and patent applications in the United States and
Canada directed to the composition of, manufacturing of, and formulations of Zohydro ER®. We license our U.S. patents and patent
applications to our commercial partner Pernix in the United States. We also own Canadian patents and patent applications
14
relating to the same technology. The patent protection for Zohydro ER® formulation provides for protection of Zohydro ER® through
2019, subject to any extensions or disclaimers. In addition, we own several issued patents in the United States and several foreign patent
applications for abuse resistant pharmaceutical compositions and methods of use related to Zohydro ER®, which provide patent protection
through 2034, subject to any extensions or disclaimers. Although certain patents may have expired or may expire in the future, we believe
there are other barriers to entry for our commercial partners and competition, including ownership of regulatory filings, NDAs, abbreviated
new drug applications or ANDAs, and drug master files or DMF’s, manufacturing trade secrets, proprietary dosage str engths, pricing
limitations in various geographies, costs to revalidate with another supplier, maturity and life-cycle stage of products.
Intellectual Property Protection Strategy
We intend to rely on a combination of patents and trade secrets, as well as confidentiality agreements and license agreements, to protect our
product candidates. Our patent strategy is designed to facilitate commercialization of our current product candidates and future product
candidates, as well as create barriers to entry for third parties. One focus of our claim strategy is on formulation claims and other related
claims.
We are seeking patent protection in the United States and internationally for our product candidates. Our policy is to pursue, maintain and
defend patent rights and to protect the technology, inventions and improvements that are commercially important to the development of our
business. We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent
applications filed by us in the future, nor can we be sure that any of our existing patents or any patents granted to us in the future will be
commercially useful in protecting our technology. We also intend to rely on trade secrets to protect our product candidates. Our
commercial success also depends in part on our non-infringement of the patents or proprietary rights of third parties.
Our success will depend significantly on our ability to:
•
•
•
•
obtain and maintain patent and other proprietary protection for our product candidates;
defend our patents;
develop trade secrets as needed and preserve the confidentiality of our trade secrets; and
operate our business without infringing the patents and proprietary rights of third parties.
We have taken steps to build and will continue to build proprietary positions for our product candidates and related technology in the
United States and abroad. We note that the patent laws of foreign countries differ from those in the United States, and the degree of
protection afforded by foreign patents may be different from the protection offered by United States patents.
Sales and Marketing
Our current intent is to develop and commercialize our product candidates in the United States while out-licensing development and
commercialization rights for other territories outside the United States, for which we own the territorial rights. We believe the initial target
audience for our product candidates will be specialty physicians, including surgeons, anesthesiologists and pain specialists. Our
management team has experience building and launching therapeutics to specialty physicians, including hospital and related settings. As
this target audience is only a portion of all physicians, we believe we have the capabilities to build a sales and marketing infrastructure and
effectively market our product candidates after FDA approval. We are establishing sales infrastructure, marketing and reimbursement
functions to commercialize IV meloxicam, if approved, in the United States. While we plan to develop and commercialize our product
candidates in the United States, we will consider potential strategic collaborations that could accelerate or enhance development and, upon
approval, commercial success of our product candidates.
Manufacturing and Supply of our Acute Care Product Candidates
We currently rely on contract manufacturers to produce drug product for our clinical studies under cGMPs, with oversight by our internal
managers. We plan to continue to rely on contract manufacturers to manufacture development quantities of our product candidates, as well
as commercial quantities of our product candidates, if and when approved for marketing by the FDA. We currently rely on a single
manufacturer for the clinical supplies of our drug product for each of our product candidates and do not currently have agreements in place
for redundant supply or a second source for any of our product candidates. We have identified other potential drug product manufacturers
that could satisfy our clinical and commercial requirements, but this would require significant expense and could produce a significant
delay in setting up the facility and moving equipment. Additionally, should a supplier or a manufacturer on whom we rely to produce a
product candidate provide us with a faulty product or a product that is later recalled, we would likely experience significant delays and
additional costs.
15
Injectable Meloxicam
Alkermes is currently our exclusive supplier of bulk injectable meloxicam. Pursuant to a Development, Manufacturing and Supply
Agreement, or Supply Agreement, Alkermes (through a subsidiary), provides clinical and commercial bulk supplies of injectable
meloxicam formulation. During the term of the Supply Agreement, we will purchase our clinical and commercial supplies of bulk
injectable meloxicam formulation exclusively from Alkermes. If the first commercial sale of injectable meloxicam occurs on or prior to
December 31, 2020, the Supply Agreement will have an initial term expiring ten years following the date of such first commercial sale.
The Supply Agreement will then automatically renew for successive one-year terms unless terminated by either party upon written notice at
least 180 days prior to the expiration of the applicable term. If the first commercial sale of injectable meloxicam has not occurred by
December 31, 2020, the Supply Agreement will expire on that date.
Patheon UK Limited, or Patheon, provides sterile fill-finish of injectable meloxicam drug product pursuant to a Master Manufacturing
Services Agreement and Product Agreement, collectively the Patheon Agreements, at its Monza, Italy manufacturing site. We have agreed
to purchase a certain percentage of our annual requirements of finished injectable meloxicam from Patheon during the term of the Patheon
Agreements. The Patheon Agreements expire on December 31, 2020 and will automatically renew thereafter for successive two-year
periods unless terminated by either party upon prior written notice.
NMBAs
We have successfully sourced the manufacturing of the NMBAs and reversing agent at a contract manufacturer for use in pre-clinical
studies and early clinical trials for these product candidates.
Dex-IN
We are party to an API supply agreement with Orion, whereby Orion provides us with API for the development and, if approved,
commercialization of Dex-IN. Prior to obtaining regulatory approval, subject to advance notice to Orion, Orion will provide API without
charge for agreed upon amounts. Any amounts ordered by us that are greater than the planned supply will be charged at 50% of the supply
price for commercial product. The single unit dose intranasal sprayer for Dex-IN is manufactured by a supplier of proprietary components
and devices. Suppliers of components, subassemblies and other materials are located in Europe, Asia and the United States.
Competition
The pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological change. Our
current and future competitors include pharmaceutical, biotechnology and specialty pharmaceutical companies. Many of our competitors
have greater financial and other resources than we have, such as more commercial resources, larger research and development staffs and
more extensive marketing and manufacturing organizations. As a result, these companies may obtain marketing approval more rapidly than
we are able to obtain and may be more effective in selling and marketing their products. Smaller or early stage companies may also prove to
be significant competitors, particularly through collaborative arrangements with large, established companies.
Our competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective or less costly
than our product candidates or any other products that we may develop which could render our products obsolete and noncompetitive. We
expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of
administration and delivery, price and the availability of reimbursement from government and other third-party payers. We also expect to
face competition in our efforts to identify appropriate collaborators or partners to help commercialize our product candidates in our target
commercial markets.
In the post-operative pain relief setting, we believe patients are prescribed injectable acetaminophen, nonsteroidal anti-inflammatory drugs,
or NSAIDs, sodium channel blockers and opioids, depending on the severity of pain. Specifically, acetaminophen, NSAIDs and sodium
channel blockers, we believe, are prescribed for mild to moderate pain relief, whereas we believe opioids are prescribed for moderate to
severe pain relief. While we will compete with all of these compounds in the post-operative pain setting, we believe injectable meloxicam
will be used to manage moderate to severe pain, competing with opioids and predominantly systemic non-opioid pain treatments. There are
a number of pharmaceutical companies that currently market and or manufacture therapeutics in the pain relief area, including Johnson &
Johnson, Purdue Pharma, L.P., Mallinckrodt plc, Teva Pharmaceutical Industries, Inc., Pacira Pharmaceuticals, Inc. and AcelRx
Pharmaceuticals, Inc. Mallinckrodt commercializes an injectable formulation of acetaminophen. Pacira commercializes an intraoperative
formulation of bupivacaine, a sodium channel blocker, that is injected or instilled at the surgical site. Additionally, companies such as
Adynxx, Inc., Durect Corporation, Heron Therapeutics, Inc., Innocoll Holdings plc, Sandoz AG, Trevena, Inc., Avenue Therapeutics, Inc.,
Neumentum Inc. and Cara Therapeutics, Inc. are currently developing post-operative pain therapeutics that could compete with IV
meloxicam in the future.
16
The CDMO segment competes with contract pharmaceutical formulation and manufacturing companies such as Alcami Corporation,
Cambrex Corporation, Mylan N.V., Catalent, Inc., Patheon, a part of Thermo Fischer Scientific, Mikart, LLC, Quotient Sciences, and other
formulation, development and manufacture-related service providers.
Information about Segment Revenue
Information about segment revenue is set forth in Note 17 to the Consolidated Financial Statements included in this Form 10-K.
Government Regulation
Governmental authorities in the United States at the federal, state and local level, and the equivalent regulatory authorities in other
countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling,
packaging, storage, record-keeping, promotion, advertising, distribution, marketing, export and import of products such as those we are
developing. Our product candidates, including our formulations of injectable meloxicam, must be approved by the FDA before they may
legally be marketed in the United States. In addition, to the extent we choose to clinically evaluate or market any products in other countries
or develop these products for future licensing to third parties, we are subject to a variety of regulatory requirements and to the authority of
the competent regulatory authorities of those other countries.
U.S. Drug Development Process
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations.
The process of obtaining regulatory approvals and ensuring compliance with appropriate federal, state, local and foreign statutes and
regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at
any time during the product development process, approval process, or after approval, may subject an applicant to administrative
enforcement or judicial sanctions. This enforcement could include, without limitation, the FDA’s refusal to approve pending applications,
withdrawal of an approval, a clinical hold, untitled or warning letters, corrective actions, product seizures, total or partial suspension of
production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties.
The process required by the FDA before a drug may be marketed in the United States generally involves the following:
•
•
•
•
•
•
completion of preclinical laboratory tests, animal studies and formulation studies, some of which must be conducted
according to Good Laboratory Practices regulations;
submission to the FDA of an investigational new drug application, or IND, which must become effective before human
clinical trials may begin;
performance of adequate and well-controlled human clinical trials according to the FDA ’s current Good Clinical
Practices, or cGCPs, to establish the safety and efficacy of the proposed drug for its intended use;
submission to the FDA of an NDA for a new drug;
satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities identified in the
NDA; and
FDA review and approval of the NDA.
The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for
our product candidates will be granted on a timely basis, if at all.
Once a pharmaceutical product candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include
laboratory evaluations of product chemistry, toxicity, formulation and stability, as well as animal studies. An IND sponsor must submit the
results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, to the
FDA as part of the IND. The sponsor must also include a protocol detailing, among other things, the objectives of the initial clinical trial,
the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an
efficacy evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30
days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold within that 30-day time period. In such a case, the
IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by
the FDA at any time before or during trials due to safety concerns regarding the product candidate or non-compliance with applicable
requirements.
17
All clinical trials of a product candidate must be conducted under the supervision of one or more qualified investigators, in accordance with
cGCP regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an IRB, must
review and approve the plan for any clinical trial before it commences at any institution. The IRB’s role is to protect the rights and welfare
of human subjects involved in clinical studies by evaluating, among other things, the potential risks and benefits to subjects, processes for
obtaining informed consent, monitoring of data to ensure subject safety, and provisions t o protect the subjects’ privacy. The IRB approves
the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal
representative and must monitor the clinical trial until completed.
Once an IND is in effect, each new clinical protocol, and any amendments to the protocol, must be submitted to the IND for FDA review
and to the IRBs for approval. Protocols detail, among other things, the objectives of the clinical trial, dosing procedures, subject selection
and exclusion criteria and the parameters to be used to monitor subject safety.
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
•
•
•
Phase I. The product is initially introduced into healthy human subjects and tested for safety, dosage tolerance,
absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases,
especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human
testing may be conducted in patients.
Phase II. Phase II trials involve investigations in a limited patient population to identify possible AEs and safety risks, to
preliminarily evaluate the efficacy of the product for specific targeted indications and to determine dosage tolerance and
optimal dosage and schedule.
Phase III. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient
population at geographically dispersed clinical trial sites. These trials are intended to establish the overall risk/benefit
ratio of the product and provide an adequate basis for regulatory approval and product labeling.
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA, and safety reports must be
submitted to the FDA and the investigators for serious and unexpected side effects. Phase I, Phase II and Phase III testing may not be
completed successfully within any specified period, if at all. Results from earlier trials are not necessarily predictive of results from later
trials. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research
subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial
at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with
unexpected serious harm to patients.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about
the chemistry and physical characteristics of the product and finalize a process for manufacturing the product in commercial quantities in
accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product
candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final
product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the
product candidate does not undergo unacceptable deterioration over its shelf life.
U.S. Review and Approval Processes
The results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical
tests conducted on the drug, proposed labeling and other relevant information, are submitted to the FDA as part of an NDA for a new drug,
requesting approval to market the product.
The submission of an NDA generally is subject to the payment of a substantial user fee for a human drug application. A waiver of such fee
may be obtained under certain limited circumstances. For example, an applicant is eligible for waiver of the application fee if the applicant
is a small business submitting its first human drug application and does not have another product approved under a human drug application
and introduced and delivered for introduction into interstate commerce. However, we did not qualify due to prior NDA approvals received
by our CDMO segment.
In addition, under the Pediatric Research Equity Act of 2003, an NDA or supplement to an NDA for a new indication, dosage form, dosing
regimen, route of administration, or active ingredient, must contain data to assess the safety and effectiveness of the drug for the claimed
indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the
product is safe and effective. The FDA may waive or defer pediatric studies under certain circumstances.
Section 505(b)(2) New Drug Applications. As an alternate path to FDA approval, particularly for modifications to drug products previously
approved by the FDA, an applicant may submit an NDA under Section 505(b)(2) of the FDCA, or a Section 505(b)(2) NDA. Section
505(b)(2) was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-
Waxman Amendments, and it permits approval of applications other than those for duplicate products and
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permits reliance for such approvals on literature or on the FDA’s findings of safety and effectiveness of an approved drug product. A
Section 505(b)(2) NDA is an application where at least some of the information required for approval comes from clinical trials not
conducted by or for the applicant and for which the applicant has not obtained a right of reference. The FDA requires submission of
information needed to support any changes relative to a previously approved drug, known as the reference product, such as published data
or new studies conducted by the applicant, including bioavailability or bioequivalence studies, or clinical trials demonstrating safety and
effectiveness. The FDA may then approve the Section 505(b)(2) NDA for all or some of the labeled indications for whic h the reference
product has been approved, as well as for any new indication sought by the applicant, unless such indications or uses are protected by
patent or exclusivity provisions covering the reference product. To the extent that a Section 505(b)(2) N DA relies on clinical trials
conducted for a previously approved drug product or the FDA’s prior findings of safety and effectiveness for a previously approved drug
product, the Section 505(b)(2) applicant must submit patent certifications in its application with respect to any patents for the reference
product that are listed in the FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to
as the Orange Book. Specifically, the applicant must certify for each listed patent that, in relevant part, (1) the required patent information
has not been filed; (2) the listed patent has expired; (3) the listed patent has not expired, but will expire on a particular date and approval is
not sought until after patent expiration; or (4) the listed patent is invalid, unenforceable or will not be infringed by the proposed new
product. A certification that the new product will not infringe the previously approved product’s listed patent or that such patent is invalid
or unenforceable is known as a Paragraph IV certification. If the applicant does not challenge one or more listed patents through a
Paragraph IV certification, the FDA will not approve the Section 505(b)(2) NDA until all the listed patents claiming the referenced pro duct
have expired.
Further, the FDA will also not approve a Section 505(b)(2) NDA until any non-patent exclusivity, such as, for example, five-year
exclusivity for obtaining approval of a new chemical entity, three-year exclusivity for an approval based on new clinical trials, or pediatric
exclusivity, listed in the Orange Book for the reference product, has expired.
If the Section 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the
Paragraph IV certification to the owner of the reference product and relevant patent holders within 20 days after the Section 505(b)(2)
NDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement suit against the Section
505(b)(2) applicant. Under the FDCA, the filing of a patent infringement lawsuit within 45 days of receipt of the notification regarding a
Paragraph IV certification automatically prevents the FDA from approving the Section 505(b)(2) NDA for 30 months, beginning on the
date the patent holder receives notice, or until the patent expires or a court deems the patent unenforceable, invalid or not infringed,
whichever is earlier. Even if a patent infringement claim is not brought within the 45-day period, a patent infringement claim may be
brought under traditional patent law, but it does not invoke the 30-month stay. Moreover, in cases where a Section 505(b)(2) application
containing a Paragraph IV certification is submitted after the fourth year of a previously approved drug’s five-year exclusivity period, and
the patent holder brings suit within 45 days of notice of certification, the 30-month period is automatically extended to prevent approval of
the Section 505(b)(2) application until the date that is seven and one-half years after approval of the previously approved reference product.
The court also has the ability to shorten or lengthen either the 30-month or the seven and one-half year period if either party is found not to
be reasonably cooperating in expediting the litigation. Thus, the Section 505(b)(2) applicant may invest a significant amount of time and
expense in the development of its product only to be subject to significant delay and patent litigation before its product may be
commercialized. Alternatively, if the NDA applicant or relevant patent holder does not file a patent infringement lawsuit within the
specified 45-day period, the FDA may approve the Section 505(b)(2) application at any time, assuming the application is otherwise
approvable.
Notwithstanding the approval of many products by the FDA pursuant to Section 505(b)(2), over the last few years, some pharmaceutical
companies and other stakeholders have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA changes its interpretation of
Section 505(b)(2), or if the FDA’s interpretation is successfully challenged in court, this could delay or even prevent the FDA from
approving any Section 505(b)(2) NDA that we submit.
FDA Review of New Drug Applications. The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive
review before it accepts them for filing. If the FDA does not find an NDA to be sufficiently complete for filing, it may request additional
information rather than accepting the NDA for filing. In this event, the sponsor must resubmit the NDA with the additional information.
The re-submitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the
FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether clinical data
demonstrates that a product is safe and effective for its intended use and whether its manufacturing process can assure the product’s
identity, strength, quality and purity. Before approving an NDA, the FDA will inspect the facility or facilities where the product is
manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in
compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. The FDA
may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved
and under what conditions. An advisory committee is a panel of independent experts who provide advice and recommendations when
requested by the FDA. The FDA is not bound by the recommendation of an advisory committee.
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The approval process is lengthy and difficult, and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not
satisfied or may require additional clinical data or other data and information. Even if such data and information are submitted, the FDA
may ultimately decide that the NDA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive
and the FDA may interpret data differently than we interpret the same data. The FDA will issue a complete response letter if the agency
decides not to approve the NDA in its present form. The complete response letter usually describes all the specific deficiencies that the
FDA identified in the NDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example,
requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant might
take to place the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit the NDA,
addressing all the deficiencies identified in the letter, withdraw the application or request an opportunity for a hearing.
If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages, or the indications for
use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain
contraindications, warnings or precautions be included in the product labeling, and the agency also may require a Risk Evaluation and
Mitigation Strategy, or REMS, if it determines that a REMS is necessary to assure that the benefits of a drug outweigh its risks. In addition,
the FDA may require Phase IV testing, which involves clinical trials designed to further assess a drug’s safety and effectiveness after NDA
approval, and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.
Patent Term Restoration and Marketing Exclusivity
Depending upon the timing, duration and specific circumstances of FDA marketing approval of our product candidates, some of our U.S.
patents may be eligible for limited patent term extension under the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit
a patent restoration term of up to five years for patent term lost during product development and the FDA regulatory review process.
However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date.
Subject to certain limitations, the patent term restoration period is generally equal to one-half of the time between the effective date of an
IND and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application.
However, each phase of the regulatory review period may be reduced by any time that the FDA finds the applicant did act not act with due
diligence. Only one patent applicable to an approved drug is eligible for the extension, and the application for the extension must be
submitted prior to the expiration of the patent and within sixty days of approval of the drug. The U.S. Patent and Trademark Office, in
consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we intend to
apply for restorations of patent term for patents that issue from some of our currently owned or licensed patents or patent applications to add
patent life beyond their current expiration dates, depending on the expected length of the clinical trials and other factors involved in the
filing of the relevant NDA.
Market exclusivity provisions under the FDCA can also delay the submission or the approval of certain applications. The FDCA provides a
five-year period of non-patent marketing exclusivity within the United States to NDAs for products containing chemical entities never
previously approved by the FDA alone or in combination. A new chemical entity means a drug that contains no active moiety that has been
approved by the FDA in any application submitted under Section 505(b) of the FDCA. An active moiety is the molecule or ion responsible
for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug
application, or ANDA, or a Section 505(b)(2) NDA submitted by another company for another version of such drug where the applicant
does not own or have a legal right of reference to all the data required for approval. This exclusivity provision does not prevent the
submission or approval of another full Section 505(b)(1) NDA, but such an NDA applicant would be required to conduct its own preclinical
and adequate, well-controlled clinical trials to demonstrate safety and effectiveness. The FDCA also provides three years of marketing
exclusivity for an NDA, Section 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability
studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application. Such
clinical trials may, for example, support new indications, dosages, routes of administration or strengths of an existing drug, or for a new
use. This exclusivity, which is sometimes referred to as clinical investigation exclusivity, prevents the FDA from approving an application
under a Section 505(b)(2) NDA or an ANDA for the same conditions of use associated with the new clinical investigations before the
expiration of three years from the date of approval. Such three-year exclusivity, however, would not prevent the approval of another
application if the applicant submits a Section 505(b)(1) NDA and has conducted its own adequate, well-controlled clinical trials
demonstrating safety and efficacy, nor would it prevent approval of an ANDA or a Section 505(b)(2) NDA product that did not incorporate
the exclusivity-protected aspects of the approved drug product.
Pediatric exclusivity is another type of exclusivity in the United States. Pediatric exclusivity, if granted, provides an additional six months
of exclusivity to any existing exclusivity (e.g., three- or five-year exclusivity) or patent protection for a drug. This six-month exclusivity,
which runs from the end of other exclusivity or patent protection, may be granted based on the voluntary completion of a pediatric trial in
accordance with an FDA-issued “Written Request” for such a trial.
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Post-Approval Requirements
Any drugs for which we receive FDA approval will be subject to continuing regulation by the FDA, including, among other things, record-
keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information,
product sampling and distribution requirements, and complying with FDA promotion and advertising requirements.
The FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Drugs may be
promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other government
agencies enforce the laws and regulations prohibiting the false or misleading promotion of drugs. The FDA also limits the promotion of
product candidates prior to their approval. With limited exceptions, pre-approval promotion is prohibited under the FDA’s regulations.
Further, manufacturers of drugs must continue to comply with cGMP requirements, which are extensive and require considerable time,
resources and ongoing investment to ensure compliance. In addition, changes to the manufacturing process may require prior FDA approval
before being implemented, and other types of changes to the approved product, such as adding new indications and additional labeling
claims, are subject to further FDA review and approval. Drug manufacturers and other entities involved in the manufacturing and
distribution of approved drugs are required to list their products and to register their establishments with the FDA and certain state agencies
and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. The
cGMP requirements apply to all stages of the manufacturing process, including the production, processing, sterilization, packaging,
labeling, storage and shipment of the drug. Manufacturers must establish validated systems to ensure that products meet specifications and
regulatory standards and test each product batch or lot prior to its release. We rely, and expect to continue to rely, on third parties for the
production of clinical and commercial quantities of our product candidates for the Acute Care segment. FDA and state inspections may
identify compliance issues at our CDMO sites or at the facilities of our contract manufacturers that may disrupt production or distribution
or may require substantial resources to correct.
The FDA may withdraw a product approval if compliance with regulatory standards is not maintained or if problems occur after the product
reaches the market. Later discovery of previously unknown problems with a product may result in restrictions on the product or even
complete withdrawal of the product from the market. Further, the failure to maintain compliance with regulatory requirements may result in
administrative or judicial actions, such as fines, untitled and warning letters, holds on clinical trials, product recalls or seizures, product
detention or refusal to permit the import or export of products, refusal to approve pending applications or supplements, restrictions on
marketing or manufacturing, consent decrees, injunctions or the imposition of civil or criminal penalties.
From time to time, legislation is drafted, introduced and passed in the U.S. Congress that could significantly change the statutory provisions
governing the approval, manufacturing and marketing of products regulated by the FDA. In addition to new legislation, the FDA
regulations and policies are often revised or reinterpreted by the agency in ways that may significantly affect our business and our product
candidates. It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and
what the impact of such changes, if any, may be. For example, in December 2016, the 21st Century Cures Act, or the Cures Act, became
law. The Cures Act contains numerous provisions, including provisions designed to speed development of innovative therapies and
encourage greater use of real-world evidence to support regulatory decision making for drugs.
The U.S. Drug Enforcement Administration and other Governmental Actions
Certain products that we manufacture are regulated as a “controlled substance” as defined in the Controlled Substances Act of 1970, or
CSA, which establishes registration, security, recordkeeping, reporting, storage, distribution and other requirements administered and
enforced by the DEA. The DEA is concerned with the control and handling of controlled substances, and with the equipment and raw
materials used in their manufacture and packaging, in order to prevent loss and diversion into illicit channels of commerce.
The DEA regulates controlled substances by controlling them in five schedules. Schedule I and II controlled substances have a high
potential for abuse, whereas Schedule III-V controlled substances have relatively decreasing potential for abuse. Therefore, the DEA
imposes more stringent controls on Schedule I and II substances than Schedule III-V substances, including stricter security controls, quotas,
and increased recordkeeping and reporting requirements. Certain of the products we manufacture and/or develop are regulated as Schedule
II controlled substances. The DEA establishes annually an aggregate quota for how much certain controlled substances that we
manufacture may be produced in total in the United States, based on the DEA’s estimate of the quantity needed to meet legitimate scientific
and medicinal needs. This limited aggregate amount that the DEA allows to be produced in the United States each year is allocated among
individual companies, who must submit applications annually to the DEA for individual production and procurement quotas. We must
receive an annual quota from the DEA in order to produce any Schedule II substance. The DEA may adjust aggregate production quotas
and individual production and procurement quotas from time to time during the year, although the DEA has substantial discretion in
whether or not to make such adjustments. In April 2018, the DEA proposed new guidelines aimed at strengthening the process for setting
controls over diversion of controlled substances and making other improvements in the quota managements regulatory system for the
production, manufacturing and procurement of controlled substances. Following a public comment period, the DEA published the final
guidelines, which were substantially similar to the proposed guidelines, in July 2018. For 2019, the DEA has proposed decreased
manufacturing quotas for the six most frequently misused opioids, including hydrocodone
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which we use in the manufacture of certain products in our CDMO division, by an average of 10% as compared to the 2018 quotas. Annual
registration is required for any facility that manufactures, distributes, dispenses, imports or exports any controlled substance. The
registration is specific to the particular location, activity and controlled substance schedule.
The DEA requires facilities that manufacture controlled substances to adhere to certain security requirements. Security requirements vary
by controlled substance schedule, with the most stringent requirements applying to Schedule I and Schedule II substances. Required
security measures include background checks on employees and physical control of inventory through measures such as cages, surveillance
cameras and inventory reconciliations. Records must be maintained for the handling of all controlled substances and periodic reports must
be made to the DEA, for example, distribution, acquisition, and inventory reports for Schedule I and II controlled substances, Schedule III
substances that are narcotics and other designated substances. Reports must also be made for thefts or losses of any controlled substance
and suspicious orders. In addition, special authorization and notification requirements apply to imports and exports.
The DEA requires drug manufacturers to design and implement a system that identifies suspicious orders of controlled substances, such as
those of unusual size, those that deviate substantially from a normal pattern and those of unusual frequency, prior to completion of the sale.
A compliant suspicious order monitoring, or SOM, system includes well-defined due diligence, “know your customer” efforts and order
monitoring.
To enforce these requirements, the DEA conducts periodic inspections of registered establishments that handle controlled
substances. Individual states also independently regulate controlled substances. We are subject to state regulation of distribution for these
products. Failure to maintain compliance with applicable requirements, particularly where noncompliance results in loss or diversion, can
result in enforcement action that could have a material adverse effect on our business, results of operations and financial condition. The
DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations, or take other
enforcement action. In certain circumstances, violations could result in criminal prosecution.
In addition to DEA regulations, the U.S. government and state legislatures have enacted legislation and regulations intended to fight the
opioid epidemic. In February 2016, the FDA released an action plan to address the opioid epidemic, which is part of a broader initiative
led by the Department of Health and Human Services, which includes the release of a new Guideline for Prescribing Opioids for Chronic
Pain, FDA’s requirement of enhanced warnings and safety labeling, and institution of a class-wide REMs as a condition of
approval. Further, the Comprehensive Addiction and Recovery Act, or CARA, was passed in 2016. CARA provides resources to improve
state monitoring of controlled substances, including opioids. A Senate bill introduced in February 2018, known as CARA 2.0, would
further limit initial prescriptions for opioids to three days, while exempting initial prescriptions for chronic care, cancer care, hospice or end
of life care, and palliative care. CARA 2.0 would also increase civil and criminal penalties for opioid manufacturers that fail to report
suspicious orders for opioids or fail to maintain effective controls against diversion of opioids. More recently, the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or Support Act, has been enacted. It provides
for further regulation as well as funding for research and development of non-addictive painkillers. State legislatures have followed in the
footsteps of the federal government in passing similar laws intended to limit prescription sales and quantities as well as increase the ability
to monitor and regulate the manufacture and sale of opioids. These efforts may result in a reduction of demand for opioid products
manufactured by our CDMO segment or government action against us if we fail to comply, both of which could have a material adverse
effect on our business.
Foreign Regulation
In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial
sales and distribution of our product candidates to the extent we choose to clinically evaluate or sell any products outside of the United
States. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory
authorities of foreign countries before we can commence marketing of the product in those countries. The approval process varies from
country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of
clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. As in the United States, post-approval
regulatory requirements, such as those regarding product manufacture, marketing or distribution, would apply to any product that is
approved outside the United States.
For example, in the European Union, we may submit applications for marketing authorizations either under a centralized, decentralized, or
mutual recognition marketing authorization procedure. The centralized procedure provides for the grant of a single marketing authorization
for a medicinal product by the European Commission on the basis of a positive opinion by the European Medicines Agency, or the EMA.
A centralized marketing authorization is valid for all European Union member states and three of the four European Free Trade Association
(EFTA) States (Iceland, Liechtenstein and Norway). The decentralized procedure and the mutual recognition procedure apply between
European Union member states. The decentralized marketing authorization procedure involves the submission of an application for
marketing authorization to the competent authority of all European Union member states in which the product is to be marketed. One
national competent authority, selected by the applicant, assesses the application for marketing authorization. The competent authorities of
the other European Union member states are subsequently required to grant marketing authorization for their territory on the basis of this
assessment, except where grounds of potential serious risk to public
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health require this authorization to be refused. The mutual recognition procedure provides for mutual recognition of marketing
authorizations delivered by the national competent authorities of European Union member states by the competent authorities of other
European Union member states. The holder of a national marketing authorization may submit an application to the competent authority of a
European Union member state requesting that this authority recognize the marketing authorization delivered by the competent authority of
another European Union member state for the same medicinal product.
We are also subject to the U.K. Bribery Act, and other third country anti-corruption laws and regulations pertaining to our financial
relationships with foreign government officials. The U.K. Bribery Act, which applies to any company incorporated or doing business in the
UK, prohibits giving, offering, or promising bribes in the public and private sectors, bribing a foreign public official or private person, and
failing to have adequate procedures to prevent bribery amongst employees and other agents. Penalties under the Bribery Act include
potentially unlimited fines for companies and criminal sanctions for corporate officers under certain circumstances. Liability in relation to
breaches of the U.K. Bribery Act is strict. This means that it is not necessary to demonstrate elements of a corrupt state of mind. However,
a defense of having in place adequate procedures designed to prevent bribery is available.
Formulary Approvals and Third-Party Payer Coverage and Reimbursement
In both the United States and foreign markets, our ability to commercialize our Acute Care segment product candidates successfully, and to
attract commercialization partners for our product candidates, depends in significant part on the availability of institutional formulary
approvals and on adequate financial coverage and reimbursement from third-party payers, including, in the United States. These payers
include the Centers for Medicare and Medicaid Services, or CMS, the federal program that runs the Medicare program and monitors the
Medicaid programs offered by each state, as well as national and regional commercial plans. Medicare is a federally funded program
managed by CMS through local Medicare Administrative Contractors that administer coverage and reimbursement for certain healthcare
items and services furnished to the elderly, disabled and other individuals with certain conditions. Medicaid is an insurance program for
certain categories of patients whose income and assets fall below state defined levels that is both federally and state funded and managed by
each state. The federal government sets general guidelines for Medicaid and each state creates specific regulations that govern its individual
program. Each government or commercial plan has its own process and standards for determining whether it will cover and reimburse a
procedure or particular product and how much it will pay for that procedure or product. Commercial plans often rely on the lead of the
governmental payers in rendering coverage and reimbursement determinations. Therefore, achieving favorable Medicare coverage and
reimbursement is usually an essential component of successfully launching a new product. The competitive position of some of our
products will depend, in part, upon the extent of coverage and adequate reimbursement for such products and for the procedures in which
such products are used. Reimbursement for our product candidates can be subject to challenge, reduction or denial by government and other
commercial plans.
A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government healthcare programs and other third-party
payers are increasingly challenging the prices charged for medical products and services and examining the medical necessity and cost-
effectiveness of medical products and services, in addition to their safety and efficacy, and have attempted to control costs by limiting
coverage and the amount of reimbursement for particular medications. Increasingly, third-party payers are challenging the prices charged
for medical products and requiring that drug companies provide them with predetermined discounts from list prices.
Payers also are increasingly changing the metrics for reimbursement rates, such as basing payment on average sales price, or ASP, average
manufacturer price, or AMP, and wholesale acquisition cost. The existing data for reimbursement based on these metrics is relatively
limited, although certain states have begun to survey acquisition cost data for the purpose of setting Medicaid reimbursement rates. CMS
surveys and publishes retail community pharmacy acquisition cost information in the form of National Average Drug Acquisition Cost files
to provide state Medicaid agencies with a basis of comparison for their own reimbursement and pricing methodologies and rates. It may be
difficult to project the impact of these evolving reimbursement mechanics on the willingness of payers to cover any products for which we
receive regulatory approval.
If we successfully commercialize any of our products, we may participate in the Medicaid Drug Rebate Program. Participation is required
for federal funds to be available for our products under Medicaid and Medicare Part B. Under the Medicaid Drug Rebate Program, we
would be required to pay a quarterly rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid
beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our
drugs under Medicaid and Part B of the Medicare program.
Federal law requires that any company that participates in the Medicaid Drug Rebate Program also participate in the Public Health
Service’s 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare
Part B. The 340B drug pricing program requires participating manufacturers to agree to charge statutorily-defined covered entities no more
than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs. These 340B covered entities include a variety of community
health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a
disproportionate share of low-income patients.
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Additionally, in order to be eligible to have its products paid for with federal funds under the Medicaid and Medicare Part B programs and
purchased by certain federal agencies and grantees, a manufacturer also must participate in the Department of Veterans Affairs, or VA,
Federal Supply Schedule, or FSS, pricing program, established by Section 603 of the Veterans Health Care Act of 1992, or VHCA. Under
this program, the manufacturer is obligated to make its innovator and single source products available for procurement on an FSS contract
and charge a price to four federal agencies, Department of Veterans Affairs, Department of Defense, or DoD, Public Health Service, and
Coast Guard, that is no higher than the statutory Federal Ceiling Price. Moreover, pursuant to regulations issued by the DoD’s TRICARE
Management Activity, now the Defense Health Agency, to implemen t Section 703 of the National Defense Authorization Act for Fiscal
Year 2008, manufacturers are required to provide rebates on utilization of their innovator and single source products that are dispensed to
TRICARE beneficiaries by TRICARE network retail pharmacies. The formula for determining the rebate is established in the regulations
and is based on the difference between the annual non-federal average manufacturer price and the Federal Ceiling Price (these price points
are required to be calculated by us under the VHCA). The requirements under the 340B, FSS, and TRICARE programs could reduce the
revenue we may generate from any products that are commercialized in the future.
There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited
than the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities. Moreover, eligibility for
coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers costs, including research,
development, manufacturing, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to
cover costs and may only be temporary. Reimbursement rates vary according to the use of the drug and the clinical setting in which it is
used. Product reimbursement may also be incorporated into existing bundled payments for other services. Net prices for drugs may be
reduced by mandatory discounts or rebates required by government healthcare programs or commercial payers and by any future relaxation
of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Limited
coverage may impact the demand for, or the price of, any product candidate for which marketing approval is obtained. Third-party payers
also may seek additional clinical evidence, including expensive pharmacoeconomic studies, beyond the data required to obtain marketing
approval, demonstrating clinical benefits and value in specific patient populations, before covering our products for those patients. If
reimbursement is available only for limited indications, we may not be able to successfully commercialize any product candidate for which
we obtain marketing approval. Our inability to promptly obtain coverage and profitable reimbursement rates from both government-funded
and commercial payers for any approved products that we develop could have a material adverse effect on our operating results, our ability
to raise capital needed to commercialize products and our overall financial condition.
In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. Moreover, the
requirements governing drug pricing and reimbursement vary widely from country to country. For example, in the European Union the sole
legal instrument at the European Union level governing the pricing and reimbursement of medicinal products is Council Directive
89/105/EEC, or the Price Transparency Directive. The aim of the Price Transparency Directive is to ensure that pricing and reimbursement
mechanisms established in European Union member states are transparent and objective, do not hinder the free movement and trade of
medicinal products in the European Union and do not hinder, prevent or distort competition on the market. The Price Transparency
Directive does not, however, provide any guidance concerning the specific criteria on the basis of which pricing and reimbursement
decisions are to be made in individual European Union member states. Neither does it have any direct consequence for pricing or levels of
reimbursement in individual European Union member states. The national authorities of the individual European Union member states are
free to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the
prices and/or reimbursement of medicinal products for human use. Some individual European Union member states adopt policies
according to which a specific price or level of reimbursement is approved for the medicinal product. Other European Union member states
adopt a system of reference pricing, basing the price or reimbursement level in their territory either, on the pricing and reimbursement
levels in other countries, or on the pricing and reimbursement levels of medicinal products intended for the same therapeutic indication.
Furthermore, some European Union member states impose direct or indirect controls on the profitability of the company placing the
medicinal product on the market.
Health Technology Assessment, or HTA, of medicinal products is becoming an increasingly common part of the pricing and
reimbursement procedures in some European Union member states. These countries include the United Kingdom, France, Germany and
Sweden. The HTA process in the European Union member states is governed by the national laws of these countries. HTA is the procedure
according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of the use of a
given medicinal product in the national healthcare systems of the individual country is conducted. HTA generally focuses on the clinical
efficacy and effectiveness, safety, cost, and cost-effectiveness of individual medicinal products as well as their potential implications for
the national healthcare system. Those elements of medicinal products are compared with other treatment options available on the market.
The outcome of HTA may influence the pricing and reimbursement status for specific medicinal products within individual European
Union member states. The extent to which pricing and reimbursement decisions are influenced by the HTA of a specific medicinal product
vary between the European Union member states.
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In 2011, Directive 2011/24/EU was adopted at European Union level. This Directive concerns the application of patients' rights in cross-
border healthcare. The Directive is intended to establish rules for facilitating access to safe and high-quality cross-border healthcare in the
European Union. Pursuant to Directive 2011/24/EU, a voluntary network of national authorities or bodies responsible for HTA in the
individual European Union member states was established. The purpose of the network is to facilitate and support the exchange of
scientific information concerning HTAs. This could lead to harmonization between European Union member states of the criteria taken into
account in the conduct of HTA in pricing and reimbursement decisions and negatively impact price in at least some European Union
member states.
United States Healthcare Reform
The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare
system. The United States government, state legislatures and foreign governments also have shown significant interest in implementing
cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement
and requirements for substitution of generic products for branded prescription drugs.
In recent years, Congress has considered reductions in Medicare reimbursement levels for drugs administered by physicians. CMS, the
agency that administers the Medicare and Medicaid programs, also has authority to revise reimbursement rates and to implement coverage
restrictions for some drugs. Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease
utilization of and reimbursement for any approved products. While Medicare regulations apply only to drug benefits for Medicare
beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates.
Therefore, any reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction in payments
from private payers.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or
collectively the Affordable Care Act, substantially changed the way healthcare is financed by both governmental and private insurers, and
significantly impacts the pharmaceutical industry. The Affordable Care Act is intended to broaden access to health insurance, reduce or
constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for
healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers, and impose
additional health policy reforms. Among other things, the Affordable Care Act expanded manufacturers’ rebate liability under the Medicaid
Drug Rebate Program by increasing the minimum Medicaid rebate for both branded and generic drugs, expanded the 340B program, and
revised the definition of AMP, which could increase the amount of Medicaid drug rebates manufacturers are required to pay to states. The
legislation also extended Medicaid drug rebates, previously due only on fee-for-service Medicaid utilization, to include the utilization of
Medicaid managed care organizations as well and created an alternative rebate formula for certain new formulations of certain existing
products that is intended to increase the amount of rebates due on those drugs. On February 1, 2016, CMS issued final regulations to
implement the changes to the Medicaid Drug Rebate program under the Affordable Care Act. These regulations became effective on April
1, 2016. There have been significant ongoing efforts to modify or eliminate the Affordable Care Act. For example, the Tax Cuts and Jobs
Act, or the Tax Act, enacted on December 22, 2017, repealed the shared responsibility payment for individuals who fail to maintain
minimum essential coverage under section 5000A of the Internal Revenue Code, commonly referred to as the individual mandate,
beginning in 2019. Further legislative changes to and regulatory changes under the Affordable Care Act remain possible. It is unknown
what form any such changes or any law proposed to replace the Affordable Care Act would take, and how or whether it may affect our
business in the future. We expect that changes to the Affordable Care Act, the Medicare and Medicaid programs, changes allowing the
federal government to directly negotiate drug prices and changes stemming from other healthcare reform measures, especially with regard
to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry
generally.
The Affordable Care Act requires pharmaceutical manufacturers of branded prescription drugs to pay a branded prescription drug fee to the
federal government. Each individual pharmaceutical manufacturer pays a prorated share of the branded prescription drug fee of $4.0 billion
in 2017, based on the dollar value of its branded prescription drug sales to certain federal programs identified in the law. Furthermore, the
law requires manufacturers to provide a 50% discount off the negotiated price of prescriptions filled by beneficiaries in the Medicare Part D
coverage gap, referred to as the “donut hole.”
The Affordable Care Act also expanded the Public Health Service ’s 340B drug pricing program. As noted above, the 340B drug pricing
program requires participating manufacturers to agree to charge statutorily-defined covered entities no more than the 340B “ceiling price”
for the manufacturer’s covered outpatient drugs. The Affordable Care Act expanded the 340B program to include additional types of
covered entities: certain free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals, each as
defined by the Affordable Care Act. Because the 340B ceiling price is determined based on AMP and Medicaid drug rebate data, revisions
to the Medicaid rebate formula and AMP definition could cause the required 340B discounts to increase.
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In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, beginning
April 1, 2013, Medicare payments for all items and services, including drugs and biologics, were reduced by 2% under the sequestration
(i.e., automatic spending reductions) required by the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of
2012. Subsequent legislation extended the 2% reduction, on average, to 2025. Continuation of sequestration or enactment of other
reductions in Medicare reimbursement for drugs could affect our ability to achieve a profit on any candidate products that are approved for
marketing.
Other Healthcare Laws and Compliance Requirements
If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our activities
may become subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the
federal civil False Claims Act, and laws and regulations pertaining to limitations on and reporting of healthcare provider payments
(physician sunshine laws). These laws and regulations are interpreted and enforced by various federal, state and local authorities including
CMS, the Office of Inspector General for the U.S. Department of Health and Human Services, the U.S. Department of Justice, individual
U.S. Attorney offices within the Department of Justice, and state and local governments. These laws include:
•
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•
•
•
the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and
willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or
in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arranging for or
recommending the purchase, lease or order of, any good or service, for which payment may be made, in whole or in
part, under federal healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual
knowledge of the statute or specific intent to violate it in order to have committed a violation;
the U.S. civil False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens
on behalf of the federal government), prohibits any person from, among other things, knowingly presenting, or causing
to be presented false or fraudulent claims for payment of government funds or knowingly making, using or causing to be
made or used, a false record or statement material to an obligation to pay money to the government or knowingly and
improperly avoiding, decreasing or concealing an obligation to pay money to the U.S. federal government;
the U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and
civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud
any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or
making any materially false statement, in connection with the delivery of, or payment for healthcare benefits, items or
services by a healthcare benefit program, which includes both government and privately funded benefits programs;
similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the
statute or specific intent to violate it in order to have committed a violation.
state laws and regulations, including state anti-kickback and false claims laws, that may apply to our business practices,
including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare
items or services reimbursed by any third-party payer, including private insurers; state laws that require pharmaceutical
companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance
guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare
providers and other potential referral sources; and state laws and regulations that require drug manufacturers to file
reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of
value provided to healthcare professionals and entities; and
the Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations,
requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare,
Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to certain
payments made in the preceding calendar year and other transfers of value to physicians and teaching hospitals, as well
as ownership and investment interests held by physicians and their immediate family members.
Violations of any of these laws or any other governmental regulations that may apply to us, may subject us to significant civil, criminal and
administrative sanctions including penalties, damages, fines, imprisonment, and exclusion from government funded healthcare programs,
such as Medicare and Medicaid, and/or adverse publicity.
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Moreover, government entities and private litigants have asserted claims under state consumer protection statutes against pharmaceutical
and medical device companies for alleged false or misleading statements in connection with the marketing, promotion and/or sale of
pharmaceutical and medical device products, including state investigations and litigation by certain government entities regarding the
marketing of opioid products.
In addition to regulations in the United States, to the extent we choose to clinically evaluate or sell any products outside of the United
States, we will be subject to a variety of foreign healthcare laws and compliance requirements. For example, in the European Union, the EU
Data Protection Directive imposes strict obligations and restrictions on the ability to collect, analyze and transfer personal data, including
health data from clinical trials and adverse event reporting. Switzerland has adopted similar restrictions. Data protection authorities from
the different European Union member states may interpret the applicable laws differently, and guidance on implementation and compliance
practices are often updated or otherwise revised, which adds to the complexity of processing personal data in the European Union.
Although there are legal mechanisms to allow for the transfer of personal data from the European Union to the U.S., the decision of the
European Court of Justice in the Schrems case (Case C-362/14 Maximillian Schrems v. Data Protection Commissioner) invalidated the Safe
Harbor framework and increased uncertainty around compliance with European Union restrictions on cross-border data transfers. As a
result of the decision, it was no longer possible to rely on Safe Harbor certification as a legal basis for the transfer of personal data from the
European Union to entities in the U.S. On February 29, 2016, however, the European Commission announced an agreement with the
United States Department of Commerce, or DoC, to replace the invalidated Safe Harbor framework with a new EU-U.S. “Privacy Shield.”
On July 12, 2016, the European Commission adopted a decision on the adequacy of the protection provided by the Privacy Shield. The
Privacy Shield is intended to address the requirements set out by the European Court of Justice in its ruling by imposing more stringent
obligations on companies, providing stronger monitoring and enforcement by the DoC and Federal Trade Commission, and making
commitments on the part of public authorities regarding access to information. U.S. companies have been able to certify to the DoC their
compliance with the privacy principles of the Privacy Shield since August 1, 2016.
On September 16, 2016, the Irish privacy advocacy group Digital Rights Ireland brought an action for annulment of the European
Commission decision on the adequacy of the Privacy Shield before the European Court of Justice (Case T-670/16). In October 2016, a
further action for annulment was brought by three French digital rights advocacy groups (Case T-738/16). Case T-670/16 and Case T-
738/16 are still pending before the European Court of Justice. If, however, the European Court of Justice invalidates the Privacy Shield, it
will no longer be possible to rely on the Privacy Shield certification to support transfer of personal data from the European Union to
entities in the US. Adherence to the Privacy Shield is not, however, mandatory. U.S.-based companies are permitted to rely either on their
adherence to the EU-US Privacy Shield or on the other authorized means and procedures to transfer personal data provided by the EU Data
Protection Directive.
In December 2015, a proposal for an EU General Data Protection Regulation, intended to replace the current EU Data Protection Directive,
introducing new data protection requirements in the EU, as well as substantial fines for breaches of the data protection rules, was agreed
between the European Parliament, the Council of the European Union and the European Commission. The EU General Data Protection
Regulation has applied since May 25, 2018. The EU Data Protection Regulation increased the responsibility and liability in relation to
personal data processed in the European Union and also introduced substantial fines for breaches of the data protection rules. Furthermore,
there is a growth towards the public disclosure of clinical trial data in the European Union which adds to the complexity of processing
health data from clinical trials. During 2018, we implemented policies and controls to adhere to the EU General Data Protection Regulation.
Corporate Information
We were incorporated under the laws of the Commonwealth of Pennsylvania in November 2007. Our principal executive offices are
located at 490 Lapp Road, Malvern, PA 19355, and our telephone number is (484) 395-2470.
Employees
We currently have 255 full-time employees and 5 temporary employees. None of our employees are covered by collective bargaining
agreements, and we consider relations with our employees to be good.
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Available Information
Our website address is www.recropharma.com. Our Annual Report on Form 10-K, quarterly reports on Form 10-Q, current reports on
Form 8-K, any amendments to those reports, proxy and registration statements filed or furnished with the Securities and Exchange
Commission, or SEC, are available free of charge through our website. We make these materials available through our website as soon as
reasonably practicable after we electronically file such materials with, or furnish such materials to, the SEC. The reports filed with the SEC
by our executive officers and directors pursuant to Section 16 under the Exchange Act are also made available, free of charge on our
website, as soon as reasonably practicable after copies of those filings are provided to us by those persons. These materials can be accessed
through the “Investor Relations” section of our website. The information contained in, or that can be accessed through, our website is not
part of this Report.
Item 1A.
Risk Factors
The following risk factors and other information included in this Annual Report on Form 10-K should be carefully considered. The risks
and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we
presently deem less significant may also impair our business operations. Please see page 4 of this Annual Report on Form 10-K for a
discussion of some of the forward-looking statements that are qualified by these risk factors. If any of the following risks occur, our
business, financial condition, results of operations and future growth prospects could be materially and adversely affected. All references
and risks related to the launch, commercialization or sale of injectable meloxicam or any of our other product candidates are predicated on
such product candidates receiving the requisite marketing and regulatory approval in the United States and applicable foreign
jurisdictions.
Risks Related to Our Finances and Capital Requirements
We have incurred net losses since inception. We expect to incur losses for the foreseeable future and may never achieve or
maintain profitability.
To date, we have focused primarily on developing our proprietary product candidates. We have incurred significant pre-tax losses
in each year since our inception in November 2007, including pre-tax losses of approximately $62.3 million and $52.0 million for the years
ended December 31, 2018 and 2017, respectively. As of December 31, 2018, we had an accumulated deficit of $188.3 million.
We have financed our operations through the sale of debt and equity securities, term loans made under our previous and existing
credit facilities, including our current $100.0 million credit facility with Athyrium Opportunities III Acquisition LP, or Athyrium, and
revenue generated by our CDMO segment. We have used revenue generated by our CDMO segment primarily to fund the operations of
our CDMO segment, to make payments under our credit facility and to partially fund our research and development and pre-
commercialization activities. We believe that our CDMO segment revenue will continue to contribute cash for general corporate purposes
that may, to some extent, reduce the amount of external capital needed to fund development and commercialization operations.
The size of our future net losses and our ability to achieve profitability will depend, in part, on the rate of future expenditures and
our ability to successfully resolve the issues raised by the FDA with regard to our NDA for IV meloxicam and obtain regulatory approval
of IV meloxicam, successfully commercialize IV meloxicam, if approved, and successfully commercialize our other current or future
product candidates, if approved. To date, none of our product candidates have been commercialized, and revenues generated by our
CDMO segment do not cover our costs and may never be sufficient to achieve profitability. Our ability to generate future revenues from
product sales depends heavily on our success in:
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adequately addressing the concerns raised by the FDA in the CRL for IV meloxicam and obtaining regulatory approval
for IV meloxicam;
obtaining the labeling we requested for IV meloxicam, if approved;
launching and commercializing IV meloxicam;
developing a sufficient commercial organization capable of sales, marketing and distribution for IV meloxicam;
establishing a commercially viable price for IV meloxicam;
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• manufacturing commercial quantities of IV meloxicam at acceptable cost levels;
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effectively managing the levels of production, distribution and delivery of IV meloxicam through our supply chain and
adequately adjusting such production and delivery to correspond to market demand;
obtaining coverage and adequate reimbursement from third-parties, including government payers;
obtaining and maintaining patent protection for IV meloxicam and our other product candidates;
completing the clinical development of our other product candidates; and
generating increased revenue from our CDMO segment.
As a result of the CRL we received in May 2018 with respect to IV meloxicam, we have incurred additional expenses, including
increased legal and consulting fees associated with addressing the CRL, and we expect to continue to incur substantial and increased
expenses as we continue our launch preparation and commercialization activities for IV meloxicam, and expand our research and
development activities and advance our clinical programs for our other product candidates. Because of the numerous risks and uncertainties
associated with pharmaceutical product development and commercialization, we are unable to predict the timing or amount of increased
expenses, and when, or if, we will be able to achieve or maintain profitability.
If IV meloxicam or our other product candidates are not successfully developed or commercialized, or if revenues are insufficient
following marketing approval, we will not achieve profitability and our business may fail. Even if we successfully obtain regulatory
approval for IV meloxicam in the United States, our revenues are also dependent upon the size of the markets outside of the United States,
as well as our ability to obtain market approval and achieve commercial success outside of the United States on our own or with a
collaboration partner.
As a result of the foregoing, we expect to continue to incur significant and increasing losses from operations for the foreseeable
future. Even if we are able to generate revenues from the sale of our products, we may not become profitable and may need to obtain
additional funding to continue operations.
If we fail to obtain sufficient additional financing, we would be forced to delay, reduce or eliminate our product
development and related commercialization programs or to significantly scale back, re-leverage or monetize our manufacturing
business.
Developing and commercializing pharmaceutical products, including conducting preclinical studies and clinical trials and ramping
up commercial manufacturing activities, is expensive. We expect our research and development expenses to increase as we continue our
ongoing clinical and pre-commercialization activities in anticipation of a potential commercial launch of IV meloxicam, advance our other
clinical programs and, if IV meloxicam is approved, scale up our commercialization activities. If we obtain regulatory approval for IV
meloxicam, we anticipate incurring significant costs of sales and general and commercialization expenses in connection with its launch and
commercialization. In addition, maintaining our cGMP pharmaceutical manufacturing facilities is expensive. While our CDMO segment
generates revenue and profit, that revenue and profit alone is not sufficient to support the development and commercialization of our
product candidates. We will need to raise additional funds to support our future product development operations. In addition, we may also
need to obtain additional financing if the capital requirements for operating and maintaining our manufacturing facilities exceed our current
expectations. Such financing may not be available to us on acceptable terms, or at all.
We expect our existing cash and cash equivalents and other expected financing sources will be sufficient to fund our operations
over the next 12 months. If the FDA requires us to conduct additional clinical trials, preclinical studies or additional chemistry,
manufacturing and controls, or CMC, work to resolve issues raised by the FDA in the CRL for IV meloxicam, we will need to raise
additional funding for the costs of conducting such clinical trials, preclinical studies and CMC work. Further, if IV meloxicam is ultimately
approved by the FDA, we will need to raise additional funding to implement our commercial launch plans for IV meloxicam and to satisfy
the milestone payments due to Alkermes following FDA approval of IV meloxicam. In addition, changing circumstances beyond our
control may cause us to consume capital more rapidly than we currently anticipate. For example, our pre-commercialization and
commercialization activities for IV meloxicam may lead to additional, unexpected costs related to the commercial manufacture of IV
meloxicam or the build-out of our commercial sales organization. We may also encounter technical, enrollment or other difficulties that
could increase our development costs more than we expect for our other product candidates. Additional funding will be needed to develop
our other product candidates.
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Securing additional financing may divert our management from our day-to-day activities, which may adversely affect our ability
to develop and commercialize our product candidates or to develop and maintain customer relationships. In addition, we cannot guarantee
that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. If we are unable to raise additional
capital when required or on acceptable terms, we may be required to:
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•
significantly delay, scale back or discontinue the development or commercialization of IV meloxicam or curtail the
development programs for our other product candidates;
seek collaboration partners for the development or commercialization of IV meloxicam or our other product candidates
at an earlier stage than otherwise would be desirable, on terms that are less favorable than might otherwise be available
or for product candidates that we would otherwise plan to develop and commercialize on our own;
relinquish or license, on unfavorable terms, our rights to technologies or product candidates that we otherwise would
seek to develop or commercialize ourselves; or
significantly scale back, re-leverage or monetize our CDMO segment.
Any of the above could have a material adverse effect on our business, operating results and prospects.
We may sell additional equity or debt securities or incur additional indebtedness to fund our operations, which would
result in dilution to our shareholders and may impose restrictions on our business.
We may seek additional capital through a combination of private and public equity offerings, debt financings, strategic
partnerships and alliances and licensing arrangements. On December 29, 2017, we entered into a Sales Agreement, or the Sales Agreement,
with Cowen and Company, LLC, or Cowen, pursuant to which we may sell from time to time, at our option, up to $40.0 million of shares
of our common stock through Cowen, as our placement agent. Through December 31, 2018, we have not sold any shares of common stock
under the Sales Agreement. On March 2, 2018, we entered into a common stock purchase agreement, or the 2018 Purchase Agreement,
with Aspire Capital Fund, LLC, or Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set
forth in the 2018 Purchase Agreement, Aspire Capital is committed to purchase, at our sole election, up to an aggregate of $20.0 million of
our shares of common stock over the approximately 30-month term of the 2018 Purchase Agreement. Through December 31, 2018, we
have sold $17.0 million in shares of our common stock under the 2018 Purchase Agreement. On February 19, 2019, we entered into a
second common stock purchase agreement, or the 2019 Purchase Agreement, with Aspire Capital which provides that, upon the terms and
subject to the conditions and limitations set forth in the 2019 Purchase Agreement, Aspire Capital is committed to purchase, at our sole
election, up to an aggregate of an additional $20.0 million of our shares of common stock over the approximately 30-month term of the
2019 Purchase Agreement. To the extent that we raise additional capital through sales of common stock under the Sales Agreement or
additional shares of common stock under the 2018 and 2019 Purchase Agreements or through the sale of equity or convertible debt
securities by any other means, existing ownership interests will be diluted, and the terms of such financings may include liquidation or
other preferences that adversely affect the rights of existing shareholders. Debt financings may be coupled with an equity component, such
as warrants to purchase shares, or repayment of the debt, which could also result in dilution of our existing shareholders’ ownership and
could include additional negative covenants that restrict our business operations. If we raise additional funds through strategic partnerships
and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, or grant
licenses on terms that are not favorable to us.
Our operating results may fluctuate significantly.
Our operating results may be subject to quarterly and annual fluctuations. Our operating results will be affected by numerous
factors, including:
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the nature and scope of any activities required to adequately address the concerns raised by the FDA in the CRL for IV
meloxicam, which may include the completion of additional clinical trials, preclinical studies and/or CMC work;
any additional delays in regulatory review and approval of IV meloxicam or our other product candidates in clinical
development;
the timing and amount of development and net sales milestones, royalties and earn-out payments payable by us under
our existing license agreements and acquisition agreements;
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fluctuations in the revenues generated by our CDMO segment, including the loss of a major customer or product;
variations in the level of expenses related to our development programs;
the success of our clinical trials through all phases of clinical development;
any newly identified side effects of IV meloxicam or our other product candidates that could delay or prevent
commercialization or cause an approved drug to be taken off the market;
changes in the fair values of our warrants and contingent consideration liabilities;
any intellectual property infringement lawsuit in which we may become involved;
our ability to obtain and maintain patent protection;
the success of our commercial launch preparations activities;
our ability to establish an effective sales and marketing infrastructure;
our dependence on third parties to supply and manufacture our product candidates and delivery devices;
the level of market acceptance for IV meloxicam or any of our other product candidates, once approved, and underlying
demand for that product and wholesalers’ buying patterns;
the amount of sales and other revenues from IV meloxicam or any of our other product candidates, once approved,
including the selling prices for such potential products and the availability of adequate third-party coverage and
reimbursement;
competition from existing products or new products that may emerge;
regulatory developments affecting our product candidates, which are not limited to but could include the imposition of a
REMS program as a condition of approval;
our execution of any additional collaborative, licensing or similar arrangements, and the timing of payments we may
make or receive under these arrangements;
our acquisition, divestiture or in-licensing of new products, product candidates or business units; and
the discontinuance, licensing or sale of any asset or segment of our business.
Due to the various factors mentioned above, and others, the results of any prior quarterly period should not be relied upon as an
indication of our future operating performance. If our quarterly operating results fall below the expectations of investors or securities
analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may,
in turn, cause the price of our stock to fluctuate substantially.
We have incurred significant indebtedness, which could adversely affect our business.
As of December 31, 2018, we had an outstanding balance under our credit agreement with Athyrium of $70 million. Upon entry
into the credit agreement with Athyrium, we drew upon an initial $60 million term loan. In December 2018 we amended the credit
agreement and drew upon a $10 million term B-1 loan. We have the ability to draw upon two additional tranches of terms loans, each in
the aggregate original principal amount of $15 million, subject to certain timing and milestone restrictions, including that we receive
regulatory approval of IV meloxicam by September 30, 2019.
Our indebtedness could have important consequences to our shareholders. For example, it:
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increases our vulnerability to adverse general economic or industry conditions;
limits our flexibility in planning for, or reacting to, changes in our business or the industries in which we operate;
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reduces proceeds we may receive as a result of any sale of our CDMO segment;
• makes us more vulnerable to increases in interest rates, as borrowings under our credit agreement with Athyrium are at
variable rates;
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limits our ability to obtain additional financing in the future for working capital or other purposes; and
places us at a competitive disadvantage compared to our competitors that have less indebtedness.
Any of the above-listed factors could materially adversely affect our business, financial condition, results of operations and cash
flows. Our credit agreement with Athyrium also contains certain financial and other covenants, including a minimum liquidity requirement
and a trailing four-quarter revenue requirement, maximum leverage ratios and includes limitations on, among other things, additional
indebtedness, paying dividends in certain circumstances, acquisitions and certain investments. The credit agreement provides for certain
mandatory prepayment events, including with respect to the proceeds of asset sales, extraordinary receipts, debt issuances and other
specified events, based on the terms of the credit agreement with Athyrium. Any failure to comply with the terms, covenants and
conditions of the credit agreement may limit our ability to draw upon additional tranches of term loans and may result in an event of default
under such agreement, which could have a material adverse effect on our business, financial condition and results of operation.
Uncertainties in the interpretation and application of the Tax Cuts and Jobs Act of 2017 could adversely affect our
business and financial condition.
The Tax Cuts and Jobs Act of 2017, or the Tax Act, enacted in December 2017, significantly changed the Internal Revenue Code
of 1986, as amended. These changes included, among other things, significant changes to corporate taxation, including a permanent
reduction to the corporate income tax rate from a top marginal rate of 35% to a flat rate of 21%, limitation of the tax deduction for interest
expense to 30% of adjusted earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80% of
current year taxable income and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced rates
regardless of whether they are repatriated, immediate deductions for certain new investments instead of deductions for depreciation
expense over time, and modifying or repealing many business deductions and credits. Any federal net operating loss carryovers created in
2018 and thereafter will be carried forward indefinitely. As a result of the Tax Act, in 2017 we incurred a one-time net expense of $7.9
million related to the remeasurement of our deferred tax balances to the new statutory rate. Notwithstanding the reduction in the corporate
income tax rate, the overall impact of the Tax Act is uncertain, and our business and financial condition could be adversely affected.
Changes in tax laws and unanticipated tax liabilities could adversely affect our effective income tax rate and ability to
achieve profitability.
We are subject to income taxes in the United States and Ireland. Our effective income tax rate in the future could be adversely
affected by a number of factors including changes in the mix of earnings in countries with differing statutory tax rates, changes in the
valuation of deferred tax assets and liabilities, reversal of established valuation allowances, changes to our operations including the
discontinuance, licensing or sale of any asset or segment of our business, changes to tax strategy, changes in transfer pricing and changes in
tax laws.
We regularly assess these matters to determine the adequacy of our tax provision, which is subject to discretion. If our
assessments are incorrect, it could have an adverse effect on our business and financial condition. There can be no assurance that income
tax laws and administrative policies with respect to the income tax consequences generally applicable to our subsidiaries or to us will not be
changed in a manner which adversely affects our shareholders. Changes in tax laws and unanticipated tax liabilities could adversely affect
our effective income tax rate and ability to achieve profitability, which could have a material adverse effect on our business, financial
condition and results of operation.
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Risks Related to Clinical Development and Regulatory Approval
Considering our receipt of a CRL from the FDA regarding our NDA for IV meloxicam, the U.S. regulatory pathway for IV
meloxicam is uncertain, and we will need to successfully address deficiencies raised by the FDA in order to obtain regulatory
approval.
In July 2017 we submitted an NDA for IV meloxicam for the management of moderate to severe pain to the FDA. On May 23,
2018, we received a CRL from the FDA regarding the NDA, which stated that the FDA determined it could not approve the NDA in its
present form. The CRL stated that data from ad hoc analyses and selective secondary endpoints suggest that the analgesic effect did not
meet the expectations of the FDA. In addition, the CRL identified certain CMC related questions on extractable and leachable data
provided in the NDA. The CRL did not identify any issues relating to the safety of IV meloxicam. In July 2018, we participated in a Type
A End-of-Review meeting with the FDA to discuss the topics covered in the CRL. Upon receipt and review of the meeting minutes, we
resubmitted the NDA for IV meloxicam in September 2018. The FDA has set a date of decision on the NDA, or PDUFA date, of March 24,
2019.
Our anticipated commercialization of IV meloxicam has been delayed by the CRL and we have incurred additional costs,
including increased legal and consulting fees, and devoted additional resources to address the FDA’s concerns raised in the CRL. Our
receipt of the CRL and delay in the commercialization of IV meloxicam has adversely affected our business and caused our stock price to
decline. While we believe that our amended NDA addresses the concerns raised by the FDA in the CRL, the FDA may not approve the
amended NDA, may require additional information, may require the completion of additional clinical trials, preclinical studies and/or CMC
work or may raise additional issues with regard to regulatory approval of IV meloxicam. Any of these items could further delay or prevent
the approval of or limit the product labeling claims for IV meloxicam.
In addition, either the substance of the items identified by the FDA in the CRL, or the CRL itself, could have an adverse impact
on future efforts to obtain marketing authorization for IV meloxicam from the EMA and other foreign regulatory authorities, or on our
future efforts to commercialize IV meloxicam and gain acceptance of IV meloxicam from third-party payors.
Should we fail to obtain regulatory approval of IV meloxicam, we may be forced to rely on our other product candidates, which
are at an earlier development stage and will require significant additional time and resources to obtain regulatory approval and proceed with
commercialization, which could have a material adverse effect on our business, financial condition and results of operations.
Regulatory approval of IV meloxicam may be delayed by the U.S. government shutdown.
Beginning on December 22, 2018, a shutdown of the U.S. federal government went into effect, which resulted in many
government agencies, including the FDA, drastically reducing or ceasing operations. While the FDA was not accepting new regulatory
approval applications during the shutdown, it was continuing to review NDAs that were submitted prior to the shutdown using funds from
the user fees paid by applicants in connection with NDA submissions. The commissioner of the FDA had indicated in public statements,
however, that user fees would only fund review of drug product NDAs until mid-February. On January 25, 2019, President Trump signed a
bill to provide funding to temporarily re-open the U.S. government for three weeks, and on February 15, 2019 President Trump signed a bill
ending the government shutdown. It is uncertain what impact the government shutdown may have of the FDA’s timing of review of
pending NDAs, despite the re-opening of the government.
This government shutdown, and any other subsequent full or partial government shutdowns, may impact the FDA’s ability to
reach a timely decision on our resubmitted NDA for IV meloxicam by the PDUFA date of March 24, 2019. If approval of the NDA is
significantly delayed, our anticipated commercial launch of IV meloxicam could be materially impacted, which could adversely affect our
business and cause our stock price to decline.
We are substantially dependent on the success of our lead product candidate IV meloxicam, which is in a later stage of
development than our other product candidates. To the extent regulatory approval of IV meloxicam is delayed or not granted, our
business, financial condition and results of operations may be materially adversely affected, and the price of our common stock
may decline.
We currently have no product candidates approved for sale, and we may never be able to develop marketable products. We are
focusing a significant portion of our activities and resources on our lead product candidate, IV meloxicam, and we believe our prospects are
highly dependent on, and a significant portion of the value of our company relates to, our ability to successfully obtain regulatory approval
for, and successfully commercialize, IV meloxicam. The regulatory approval of IV meloxicam is subject to many risks, including the risks
discussed in other risk factors, and IV meloxicam may not receive marketing approval from any regulatory agency. If the results or timing
of regulatory filings, the regulatory process, regulatory developments, clinical trials or preclinical studies, or other activities, actions or
decisions related to IV meloxicam do not meet our or others’ expectations, the market price of our common stock could decline
significantly.
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We have resubmitted the NDA for IV meloxicam and the FDA has set a PDUFA date of March 24, 2019. If the FDA re quires us
to conduct additional clinical trials, preclinical studies or CMC work in connection with our resubmitted NDA, our timeline for
commercialization of IV meloxicam will be further delayed and we will incur additional costs. Further, there can be no assurance that we
will complete any additional required clinical and non-clinical studies in a manner that is acceptable to the FDA. In addition, we are
conducting Phase IIIb clinical trials for IV meloxicam in colorectal surgery patients and orthopedic surgery patients, and those clinical trials
could fail or produce results that are adverse or inconclusive, which could have a negative impact on regulatory approval.
Any further delay or setback in the development or regulatory approval of IV meloxicam could adversely affect our business and
cause our stock price to decline. We cannot assure you that we will be able to obtain approval for IV meloxicam from the FDA. Should we
fail to obtain regulatory approval of IV meloxicam, we may be forced to rely on our other product candidates, which are at an earlier
development stage and will require significant additional time and resources to obtain regulatory approval and proceed with
commercialization, which could have a material adverse effect on our business, financial condition and results of operations.
If we fail to obtain approval for the product labeling requested in our NDA for IV meloxicam, our ability to successfully
market IV meloxicam may be adversely affected.
The FDA raised certain concerns in the CRL that could ultimately lead the FDA to conclude that information in our NDA is not
sufficient to support a product label with claims covering management of moderate to severe pain or 24-hour dosing intervals. We have
made changes to our dosage and administration section of the product label to address the FDA’s concerns regarding onset and duration of
analgesic effect and these changes were included in our September 2018 resubmission of our NDA. If the approval of IV meloxicam is for a
more limited indication or different dosing interval, our ability to market to our full target market may be reduced. We could need to
significantly revise our launch and commercialization strategy, which could delay commercial launch of IV meloxicam, if approved, and
could significantly limit our ability to realize the full market potential of IV meloxicam. The approved labeling could decrease the target
market to a point where we would be unable to achieve profitability from IV meloxicam, in which case we may be forced to limit or
discontinue the commercialization of IV meloxicam, or seek a collaboration partner for the commercialization of IV meloxicam, all of
which would have an adverse impact on our business.
In addition, the labeling approved by the FDA could also significantly limit the approved indications for use, require that
precautions, contraindications or warnings be included on the product labeling, including black box warnings, require expensive and time-
consuming post-approval clinical trials, REMS or surveillance as conditions of approval, or, through product labeling limit the claims that
we may make, any of which may also impede the successful commercialization of IV meloxicam, which would have an adverse impact on
our business.
Our development of IV meloxicam depends, in part, on published scientific literature and the FDA’s prior findings
regarding the safety and efficacy of approved products containing meloxicam based on data not developed by us, but upon which
the FDA may rely in reviewing our NDA.
Section 505(b)(2) of the FDCA permits the filing of an NDA where at least some of the information required for approval comes
from investigations that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use
from the person by or for whom the investigations were conducted. The FDA interprets Section 505(b)(2) of the FDCA, for purposes of
approving an NDA, to permit the applicant to rely, in part, upon published literature or the FDA’s previous findings of safety and efficacy
for an already-approved reference product. The FDA may also require companies to perform additional clinical trials or measurements to
support any deviation from the reference product. The FDA may then approve the new product candidate for all or some of the label
indications for which the reference product has been approved, as well as for any new indication sought by the Section 505(b)(2)
applicant. The label, however, may require all or some of the limitations, contraindications, warnings or precautions included in the
reference product’s label, including a black box warning, or may require additional limitations, contraindications, warnings or
precautions. Our NDA for IV meloxicam was submitted under Section 505(b)(2) and as such the NDA relies, in part, on the FDA’s
previous findings of safety and efficacy from investigations for approved products containing meloxicam and published scientific literature
for which we have not received a right of reference. Even though we may be able to take advantage of Section 505(b)(2) to support
potential U.S. approval for IV meloxicam, the FDA may require us to perform additional clinical trials or measurements to support
approval. In addition, notwithstanding the approval of many products by the FDA pursuant to Section 505(b)(2), if the FDA changes its
interpretation of Section 505(b)(2), or if the FDA’s interpretation is successfully challenged in court, this could delay or even prevent the
FDA from approving our NDA for IV meloxicam or any other Section 505(b)(2) NDAs that we submit. Such a result could require us to
conduct additional testing and costly clinical trials, which could substantially delay or prevent the approval and launch of IV meloxicam,
which could have a material adverse effect on our business, financial condition and results of operations.
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IV meloxicam and our other product candidates may cause adverse events or other safety concerns or have other
properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.
AEs caused by IV meloxicam and our other product candidates could cause us, other reviewing entities, clinical study sites or
regulatory authorities to interrupt, delay or halt clinical studies and could result in the denial of regulatory approval. Clinical studies
conducted with IV meloxicam and our other product candidates have generated some AEs, and in some cases SAEs, as those terms are
defined by the FDA in its regulations, and AEs or SAEs could be generated during our on-going Phase IIIb clinical trials for IV
meloxicam. Our ability to obtain regulatory approval for IV meloxicam and our other product candidates may be adversely impacted by
these AEs, SAEs or other safety concerns. Further, if our products cause serious or unexpected side effects after receiving market
approval, a number of potentially significant negative consequences could result, including:
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regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in a form of a
modified REMS;
regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
we may be required to change the way the product is administered or conduct additional clinical studies;
we could be sued and held liable for harm caused to patients; and/or
our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the affected product candidate and
could substantially increase the costs of commercializing our product candidates, which could have a material adverse effect on our
business, financial condition and results of operations.
IV meloxicam or any of our other product candidates, if approved, may require REMS, which may significantly increase
our costs.
IV meloxicam or any of our other product candidates, if approved, may require REMS. The REMS may include requirements for
special labeling or medication guides for patients, special communication plans to health care professionals and restrictions on distribution
and use. We cannot predict the specific scope or magnitude of REMS that may be required as part of the FDA’s approval of IV meloxicam
or our other product candidates. Depending on the extent of the REMS requirements, our costs to commercialize IV meloxicam or our
other product candidates may increase significantly and distribution restrictions could limit sales, which could have a material adverse
effect on our business, financial condition and results of operations. Similar obstacles may arise in countries outside of the United States.
We will need to obtain approval for any proposed names for IV meloxicam, and any delay associated with doing so could
delay commercialization of IV meloxicam, and adversely impact our business.
The proprietary name we propose to use with IV meloxicam in the United States must be reviewed and accepted by the FDA,
regardless of whether we have registered it, or applied to register it, as a trademark. The FDA reviews any proposed product name,
including an evaluation of the potential for confusion with other product names. The FDA may also object to a product name if it believes
the name inappropriately implies medical claims or contributes to an overstatement of efficacy. Although the FDA has conditionally
accepted our proposed proprietary product name for IV meloxicam, it may still object to the proposed proprietary product name at the time
of any NDA approval, which would require us to expend significant additional resources in an effort to identify a suitable proprietary
product name that would qualify under applicable laws, not infringe the existing rights of third parties and be acceptable to the FDA, all of
which could delay commercialization of IV meloxicam, and adversely impact our business.
Even if we obtain regulatory approval for our product candidates, we will still face extensive regulatory requirements and
our products may face future regulatory difficulties.
Even if we obtain regulatory approval in the United States or other countries, the FDA and state regulatory authorities and the
equivalent regulatory authorities in other countries may still impose significant restrictions on the indicated uses or marketing of our
product candidates, or impose ongoing requirements for potentially costly post-approval studies or post-marketing surveillance. Any
approved products will also be subject to ongoing FDA requirements governing the labeling, packaging, storage, distribution, safety
surveillance, advertising, promotion, record-keeping and reporting of safety and other post-marketing information. The holder of an
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approved NDA is obligated to monitor and report AEs and any failure of a product to meet the specifications in the NDA. The holder of an
approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product,
product labeling or manufacturing process. Advertising and promotional materials must comply with FDA rules and are subject to FDA
review, in addition to other potentially applicable federal and state laws. The applicable regulations in countries outside the United States
grant similar powers to the competent authorities and impose similar obligations on companies.
In addition, manufacturers of drug products and their facilities are subject to payment of substantial user fees and continual review
and periodic inspections by the FDA and other regulatory authorities, including equivalent regulatory authorities in other countries, for
compliance with cGMP regulations and adherence to commitments made in the NDA or the application for marketing authorization. If we,
or a regulatory authority, discover previously unknown problems with a product, such as AEs of unanticipated severity or frequency, or
problems with a facility where the product is manufactured, a regulatory authority may impose restrictions relative to that product or the
manufacturing facility, including requiring recall or withdrawal of the product from the market, suspension of manufacturing, or other FDA
action or other action by the equivalent regulatory authorities in other countries.
If we fail to comply with applicable regulatory requirements following approval of any of our product candidates, a regulatory
authority may:
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issue a warning letter asserting that we are in violation of the law;
seek an injunction or impose civil or criminal penalties or monetary fines;
suspend, modify or withdraw regulatory approval;
suspend any ongoing clinical trials;
refuse to approve a pending NDA or supplements to an NDA submitted by us;
seize our product candidate; and/or
refuse to allow us to enter into supply contracts, including government contracts.
If any of the above were to occur, our ability to successfully commercialize any approved product candidates and achieve profitability
could be negatively impacted, which could have a material adverse effect on our business, financial condition and results of operations.
Even if we obtain FDA approval for IV meloxicam or our other product candidates in the United States, we may never
obtain approval for or commercialize our products outside of the United States, which would limit our ability to realize their full
market potential.
In order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory
requirements of other countries regarding quality, safety and efficacy. Clinical trials conducted in one country may not be accepted by
regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in
any other country. Approval processes vary among countries and can involve additional product testing and validation and additional
administrative review periods. Seeking foreign regulatory approval could result in difficulties and costs for us and require additional non-
clinical studies or clinical trials, which could be costly and time-consuming. Regulatory requirements can vary widely from country to
country and could delay or prevent the introduction of our products in those countries. While our management has experience in obtaining
foreign regulatory approvals, we do not have any product candidates approved for sale in any jurisdiction, including international markets,
and we, as a company, do not have experience in obtaining regulatory approval in international markets. If we fail to comply with
regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approval in international
markets is delayed, our target market will be reduced, and our ability to realize the full market potential of our products will be adversely
affected.
For example, in the European Union, similar to the United States regulation scheme, both marketing authorization holders and
manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA and the competent authorities of the
individual European Union member states both before and after grant of the manufacturing and Marketing Authorizations. This includes
control of compliance with cGMP rules, which govern quality control of the manufacturing process and require documentation policies and
procedures. We and our third-party manufacturers are required to ensure that all of our processes, methods, and equipment are compliant
with cGMP. Failure by us or by any of our third-party partners, including suppliers,
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manufacturers, and distributors to comply with European Union laws and the related national laws of individual European Union member
states governing the conduct of clinical trials, manufacturing approval, marketing authorization of medicinal products, both before and after
grant of marketing authorization, and marketing of such products following grant of authorization may result in administrative, civil, or
criminal penalties. These penalties could include delays in or refusal to authorize the conduct of clinical trials or to grant Marketing
Authorization, product withdrawals and recalls, product seizures, suspension, or variation of the marketing authorization, total or partial
suspension of production, distribution, manufacturing, or clinical trials, operating restrictions, injunctions, suspension of licenses, fines, and
criminal penalties, which could have a material adverse effect on our business, financial condition and results of operations.
The regulatory approval processes of the FDA are lengthy, time-consuming and inherently unpredictable, and if we are
ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
The time required to obtain approval by the FDA is unpredictable but typically takes many years following the commencement of
clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval
policies, regulations, or the type and amount of clinical data necessary to gain approval may change during a product candidate’s clinical
development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate, and it is possible that
none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory
approval.
Our product candidates could fail to receive regulatory approval for many reasons, including the following:
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the FDA may not accept our NDA filing;
the FDA may disagree with the design, scope or implementation of our clinical trials;
we may be unable to demonstrate to the satisfaction of the FDA that a product candidate is safe and effective for its
proposed indication;
we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
the FDA may disagree with our interpretation of data from preclinical studies or clinical trials;
the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an
NDA;
the FDA may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we
contract for clinical and commercial supplies; and
the approval policies or regulations of the FDA may change significantly in a manner rendering our clinical data
insufficient for approval.
For example, we have received a CRL from the FDA with regard to our NDA for IV meloxicam and have resubmitted our
NDA. We cannot be certain that any of our product candidates will receive regulatory approval. If we do not receive regulatory approval
or any of our product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approval to
market one of our product candidates, our revenue will be dependent, to a significant extent, upon the size of the markets in the territories
for which we gain regulatory approval. If the markets for patients or indications that we are targeting are not as significant as we estimate,
we may not generate significant revenue from sales of such products, if approved, which could have a material adverse effect on our
business, financial condition and results of operations.
Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials
may not be predictive of future trial results. Clinical failure can occur at any stage of clinical development.
Clinical trials are expensive, can take many years to complete and have highly uncertain outcomes. Failure can occur at any time
during the clinical trial process as a result of inadequate study design, inadequate performance of a drug, inadequate adherence by patients
or investigators to clinical trial protocols, or other factors. New drugs in later stages of clinical trials may fail to show the desired safety and
efficacy traits despite having progressed through earlier clinical trials. Some of our pipeline product candidates are in early stages of
development, and positive preclinical and Phase I clinical trials for those product candidates may not necessarily be predictive of the results
of later stage clinical trials. A number of companies in the biopharmaceutical industry have suffered
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significant setbacks in advanced clinical trials as a result of a lack of efficacy or adverse safety profiles, despite promising results in earlier
trials. Our clinical trials may not be successful or may be more expensive or time-consuming than we currently expect. If clinical trials for
any of our product candidates fail to demonstrate safety or efficacy to the satisfaction of the FDA or the equivalent regulatory authorities in
other countries, the FDA or the equivalent regulatory authorities in other countries will not approve that drug and we would not be able to
commercialize it, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and
jeopardize or delay our ability to obtain regulatory approval and commence product sales.
We may experience delays in clinical trials of our product candidates or the time required to complete clinical trials for our
product candidates may be longer than anticipated. Our planned clinical trials may not begin on time, have an effective design, enroll a
sufficient number of patients, or be completed on schedule, if at all. Our clinical trials can be delayed for a variety of reasons, including,
but not limited to:
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inability to raise funding necessary to initiate or continue a trial;
delays in obtaining regulatory approval to commence a trial;
delays in reaching an agreement with the FDA or the equivalent regulatory authorities in other countries on final trial
design or the scope of the development program;
imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or the
equivalent regulatory authorities in other countries;
delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
delays in obtaining required IRB approval at each site;
delays in recruiting suitable patients to participate in a trial;
delays in having subjects complete participation in a trial or return for post-treatment follow-up;
clinical sites dropping out of a trial to the detriment of enrollment;
time required to add new clinical sites; or
delays by our contract manufacturers to produce and deliver a sufficient supply of clinical trial materials.
For example, the FDA had imposed a clinical hold on two of our early-stage product candidates, RP1000 and the reversal agent.
While the clinical hold on RP1000 has been lifted, the reversal agent remains under clinical hold and we will be unable to proceed with
clinical development on that product candidates until the clinical hold is resolved. If we are unable to resolve these issues with the FDA, or
if clinical trials for any of our other product candidates are delayed for any of the above reasons or other reasons, our development costs
may increase, our approval process could be delayed and our ability to commercialize our product candidates could be materially harmed,
which could have a material adverse effect on our business, financial condition or results of operations.
Risks Related to Commercialization of Our Product Candidates
We have no history of commercializing drugs, which may make it difficult to predict our future performance or evaluate
our business and prospects.
Although we commenced operations in 2007, our operations have been primarily limited to developing our technology and
undertaking non-clinical studies and clinical trials for our product candidates. We have not yet obtained regulatory approval for any of our
product candidates. To date, we have not yet demonstrated our ability to successfully manufacture at commercial scale or arrange for a
third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product
commercialization. Because our success is dependent on our ability to commercialize IV meloxicam, any predictions about our future
success or viability may not be as accurate as they could be if we had a longer history of successfully developing and commercializing
drugs.
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Our anticipated commercial launch of IV meloxicam has been significantly delayed, which has changed our
commercialization strategy and could adversely impact our ability to successfully commercialize IV meloxicam.
Due to receipt of the CRL from the FDA regarding IV meloxicam, our anticipated commercial launch of IV meloxicam has been
delayed from summer of 2018 to 2019, if approved. Our initial commercial launch plans have changed. We now intend to launch with a
sales team of approximately 80 to 100 sales representatives. This will require us to hire more sales force members, which will increase our
costs. In addition, we may face challenges when recruiting a sufficient number of sales representatives. If we are unable to hire the planned
sales team for the commercial launch of IV meloxicam, our commercialization of IV meloxicam may be adversely impacted, which could
have a material adverse effect on our business, financial condition and results of operations.
If we are unable to successfully commercialize IV meloxicam, our business, financial condition and results of operations
may be materially adversely affected and the price of our common stock may decline.
Even if we receive regulatory approval from the FDA for the labeling that we request, our ability to successfully commercialize
IV meloxicam will depend on many factors, including but not limited to:
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our ability to create sufficient capital (through debt, equity or both) to support the product launch;
any negative perception of IV meloxicam as a result of receipt of the CRL from the FDA, even if ultimately resolved;
the results of our ongoing Phase IIIb clinical trials for IV meloxicam;
our ability to consistently manufacture commercial quantities of IV meloxicam at a reasonable cost and with sufficient
speed to meet commercial demand, which may be higher or lower than expected demand on which our manufacturing
forecasts have been based;
our ability to build a sales and marketing organization to market IV meloxicam;
our success in educating physicians, patients and caregivers about the benefits, administration and use of injectable
meloxicam;
our share of promotional “voice” during launch versus other existing or new products in our market segment;
the availability, perceived advantages, relative cost, relative safety and relative efficacy of competing products;
our ability to successfully defend any challenges to our intellectual property relating to IV meloxicam;
our ability to set an acceptable price for IV meloxicam and to obtain adequate coverage and adequate reimbursement for
IV meloxicam;
our ability to contract with pharmaceutical wholesalers and specialty distributors on acceptable term;
the effectiveness of our marketing campaigns;
our effective use of promotional resources;
our success in obtaining formulary approvals; and
a continued acceptable profile for IV meloxicam.
Many of these matters are beyond our control and are subject to other risks described elsewhere in this “Risk Factors”
section. Accordingly, we cannot assure that we will be able to successfully commercialize or generate revenue from IV meloxicam, even if
we receive regulatory approval for the labeling that we have requested. If we cannot do so or are significantly delayed in doing so, our
business, financial condition and results of operations may be materially adversely affected and the price of our common stock may
decline.
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If we fail to supply IV meloxicam in sufficient quantities and at acceptable quality levels, we may face delays in the
commercialization of IV meloxicam, if approved, or be unable to meet market demand, and may lose potential revenues.
Our ability to supply sufficient quantities of IV meloxicam is substantially dependent on the performance of third-party
manufacturers. We do not own facilities with capabilities for clinical-scale or commercial manufacturing of injectable meloxicam and we
rely, and expect to continue to rely, on third-party suppliers and contract manufacturers to manufacture injectable meloxicam. Alkermes is
currently our sole supplier of bulk injectable meloxicam formulation and is the only established supplier of bulk injectable meloxicam
formulation. We have committed to purchase our current requirements of injectable meloxicam formulation from Alkermes, and we have
commissioned dedicated space in Alkermes’ manufacturing facility for the production of bulk injectable meloxicam. Patheon provides
sterile fill and finish services for injectable meloxicam.
Although our supply agreement and manufacturing agreements for injectable meloxicam allow us to qualify and purchase from an
alternative supplier or manufacturer in certain circumstances, it would be time-consuming and expensive for us to do so, and there can be
no assurance that an alternative supplier could be found on terms that are acceptable to us or at all. The number of potential manufacturers
that have the necessary equipment, expertise and governmental licenses to produce IV meloxicam is limited. If we encounter any issues
with our contract manufacturers or choose to engage a new supplier or contract manufacturer for IV meloxicam, we would need to qualify
and obtain FDA approval for another contract manufacturer or supplier as an alternative source, which could be costly and cause significant
delays.
Our reliance on a limited number of vendors to manufacture IV meloxicam exposes us to risks, any of which could delay
commercialization of our products, result in higher costs, or deprive us of potential revenues. Our contract manufacturers may encounter
difficulties in achieving the volume of production needed to satisfy our demand for commercial launch and ongoing commercial demand
(even after accounting for the increased capacity to be provided by the dedicated space at the Alkermes facility), may experience technical
issues that impact quality or compliance with applicable and strictly enforced regulations governing the manufacture of pharmaceutical
products, may be affected by natural disasters that interrupt or prevent manufacturing of our products, may experience shortages of
qualified personnel to adequately staff production operations, may experience shortages of raw materials and may have difficulties finding
replacement parts or equipment. In addition, our contract manufacturers could default on their agreement with us to meet our requirements
for commercial supplies of IV meloxicam and/or Alkermes could fail to deliver the dedicated space according to the currently agreed
timeline.
We and our contract manufacturers must comply with federal, state and foreign regulations, including FDA’s regulations
governing current cGMP, enforced by the FDA through its facilities inspection program and by similar regulatory authorities in other
jurisdictions where we do business. These requirements include, among other things, quality control, quality assurance and the maintenance
of records and documentation. The FDA or similar foreign regulatory authorities at any time may implement new standards, or change their
interpretation and enforcement of existing standards for manufacture, packaging or testing of our products. Our contract manufacturers are
subject to ongoing periodic unannounced inspection by the FDA to ensure compliance with these regulations. Any failure to comply with
applicable regulations may result in fines and civil penalties, suspension of production, product seizure or recall, imposition of a consent
decree, or withdrawal of product approval, and would limit the availability of IV meloxicam. Any manufacturing defect or error discovered
after IV meloxicam has been produced and distributed also could result in significant consequences, including costly recall procedures, re-
stocking costs, damage to our reputation and potential for product liability claims.
While we have scaled up our commercial manufacturing of IV meloxicam in anticipation of a potential commercial launch, due to
the delay in our anticipated commercial launch of IV meloxicam as a result of the CRL, we have launch stock of IV meloxicam that,
depending on the approved expiration date, could be unable to be sold or could be sold but returned by our wholesalers if expired prior to
final sale. A significant amount of expired product or returned product could impact the success of our commercial launch of IV
meloxicam, if approved.
If, as a result of any of these issues, we are unable to supply the required commercial quantities of IV meloxicam to support
commercial launch and meet market demand for IV meloxicam, if approved, on a timely basis or at all, we may suffer damage to our
reputation and commercial prospects and we will lose potential revenues.
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The commercial success of IV meloxicam and our other product candidates will depend upon the acceptance of these
products by the medical community, including physicians, patients, health care payers and hospital formularies.
Physicians may not prescribe IV meloxicam or any of our other product candidates if approved by the FDA, in which case we
would not generate the revenues we anticipate. The degree of market acceptance of any of our product candidates will depend on a number
of factors, including:
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demonstration of clinical safety and efficacy;
the prevalence and severity of any AEs;
the indications for which each of our product candidates are approved, including any dosing instructions and potential
additional restrictions placed on each product candidate in connection with its approval;
limitations or warnings contained in the FDA-approved label for each product candidate;
the results of our ongoing Phase IIIb clinical trials for IV meloxicam;
relative convenience and ease of administration of our product candidates;
prevalence of the condition for which each product candidate is approved;
availability of alternative treatments and perceived advantages of our product candidates over such alternative
treatments;
the proposed sales price and cost-effectiveness of IV meloxicam and the availability of adequate third-party coverage
and reimbursement;
the effectiveness of our or any future collaborators’ sales and marketing strategies;
our ability to convince hospitals to include IV meloxicam and our other product candidates on their list of authorized
products, referred to as formulary approval;
consolidation among healthcare providers, which increases the impact of the loss of any relationship;
our ability to obtain and maintain sufficient third-party coverage or reimbursement; and
the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
In addition, market acceptance of IV meloxicam could be negatively impacted by any negative perception physicians may have of
IV meloxicam following announcement of the CRL received from the FDA for IV meloxicam, even if subsequently resolved. If IV
meloxicam or any of our other product candidates are approved but do not achieve an adequate level of acceptance by physicians, patients
and healthcare payers, we may not generate sufficient revenue and we may not become or remain profitable.
If third-party payers do not reimburse physicians or patients for IV meloxicam or our other product candidates or if
reimbursement levels are, or pricing pressures cause the sales price to be, set too low for us to sell IV meloxicam or our other
product candidates at a profit, our ability to successfully commercialize IV meloxicam or our other product candidates and our
results of operations will be harmed.
Our ability to commercialize IV meloxicam or our other product candidates successfully will depend in part on the extent to
which coverage and adequate reimbursement for such products, once approved, will be available in a timely manner from third-party
payers, including governmental healthcare programs such as Medicare and Medicaid, commercial health insurers and managed care
organizations and other pricing limitations such as mandatory rebates or discounts. Reimbursement and pricing limitations may hinder our
ability to recoup our investment in IV meloxicam and our other product candidates, even if approved.
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Government authorities and other third-party payers, such as private health insurers and health maintenance organizations,
determine which medications they will cover and establish reimbursement levels. Reimbursement decisions by particular third-party
payers depend upon a number of factors, including each third-party payer’s determination that use of a product is:
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a covered benefit under its health plan;
appropriate and medically necessary for the specific condition or disease;
cost-effective; and
neither experimental nor investigational.
Obtaining coverage and reimbursement approval for IV meloxicam or our other product candidates from government authorities
or other third-party payers may be a time consuming and costly process that could require us to provide supporting scientific, clinical and
cost-effectiveness data, including expensive pharmacoeconomic studies beyond the data required to obtain marketing approval, for the use
of IV meloxicam or our other product candidates to each government authority or other third-party payer. For example, if our ongoing
Phase IIIb clinical trials for IV meloxicam in colorectal surgery patients and orthopedic surgery patients do not show improved outcomes
relative to the current standard of care, obtaining payer coverage could be more difficult. We may not be able to provide data sufficient to
gain acceptance with respect to coverage and reimbursement. In addition, acceptance by third-party payers could be negatively impacted by
any negative perception third-party payers may have of IV meloxicam following announcement of the CRL received from the FDA for IV
meloxicam, despite subsequent FDA approval.
Third-party payers may deny reimbursement for covered products if they determine that a medical product was used for an
unapproved indication. Third-party payers may also limit coverage to specific products on an approved list, or formulary, which might not
include all of the FDA-approved products for a particular indication. Failure to obtain timely hospital formulary approval will limit our
commercial success, and obtaining such approval can be an expensive and time-consuming process. We cannot be certain if and when we
will obtain the formulary approvals to allow us to sell our products into our target markets, nor, if formulary approval is obtained, at what
price our products will be accepted for sale and reimbursement.
Increasingly, third-party payers are also requiring that drug companies provide them with predetermined discounts from list prices
and are challenging the prices charged for medical products. These third-party payers could also impose price controls restricting the prices
at which the products will be reimbursed and other conditions that must be met by patients prior to providing coverage for the use of IV
meloxicam or our other product candidates.
Third-party payers are increasingly attempting to contain healthcare costs by limiting both coverage and the level of
reimbursement for medical products and services, which can impact the demand for, or the price of, such products and services. The
process for determining whether a payer will provide coverage for a product may be separate from the process for setting the price or
reimbursement rate that the payer will pay for the product once coverage is approved. Levels of reimbursement may also decrease in the
future, due to the availability of numerous generic pain medications available at lower costs or future legislation, regulation or
reimbursement policies of third-party payers which may adversely affect the demand for and reimbursement available for IV meloxicam or
our other product candidates, which in turn, could negatively impact pricing. If patients are not adequately reimbursed for IV meloxicam
or our other product candidates, they may reduce or discontinue purchases of it.
Moreover, eligibility for coverage and reimbursement does not imply that any drug will be paid for in all cases or at a rate that
covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if
applicable, may also not be sufficient to cover our costs and may only be temporary. Reimbursement rates may vary according to the use of
the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be
incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by
government healthcare programs or private payers and by any future relaxation of laws that presently restrict imports of drugs from policy
and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable
reimbursement rates from both government-funded and private payers for IV meloxicam and our other product candidates, if approved,
could result in a significant shortfall in achieving revenue expectations, prevent us from achieving profitability and negatively impact our
business, prospects and financial condition
Legislative or regulatory programs that may influence prices of prescription drugs could have a material adverse effect on
our ability to successfully commercialize IV meloxicam and our other product candidates.
Current or future federal or state laws and regulations may influence the prices of drugs and, therefore, could adversely affect the
prices that we receive for IV meloxicam or our other product candidates, if approved. Programs in existence in certain states seek to set
prices of all drugs sold within those states through the regulation and administration of the sale of prescription drugs. Expansion of these
programs, in particular, state Medicaid programs, or changes required in the way in which Medicaid rebates are calculated under such
programs, could adversely affect the price we receive for IV meloxicam or our other product candidates, if approved, and could have a
material adverse effect on our business, results of operations and financial condition.
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Further, the pharmaceutical industry has in recent years been the subject of significant publicity regarding the pricing of
pharmaceutical products, including publicity and pressure resulting from prices charged by pharmaceutical companies for new products as
well as price increases by pharmaceutical companies on older products that the public has deemed excessive. Any downward pricing
pressure on the price of IV meloxicam or our other product candidates, if approved, arising from social or political pressure to lower the
cost of pharmaceutical products could have a material adverse impact on our business, results of operations and financial condition. As a
result, pharmaceutical product prices have been the focus of increased scrutiny by the government, including certain state attorneys
general, members of congress and the United States Department of Justice. Decreases in health care reimbursements or prices of IV
meloxicam or our other product candidates, if approved, could limit our ability to sell our IV meloxicam or our other product candidates, if
approved, or decrease our revenues, which could have a material adverse effect on our business, results of operations and financial
condition.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and
sell IV meloxicam or our other product candidates, we may be unable to generate any revenue for IV meloxicam or our other
product candidates.
In anticipation of the approval and commercialization of IV meloxicam, we have begun to build out our sales, marketing and
distribution capabilities, and will need to continue to do so. Our sales force expansion was negatively impacted by our receipt of a CRL
with respect to IV meloxicam and the delay in potential commercialization of IV meloxicam to 2019. We were forced to withdraw many of
the offers of employment we had made to sale force representatives in anticipation of a 2018 commercial launch. We will need to hire
additional sales personnel, and, due to the CRL and other market dynamics, this recruitment and hiring may be more difficult.
In addition, we may discover that the cost of continuing to establish, expand and maintain such sales force may exceed the cost-
effectiveness of doing so. In order to market IV meloxicam, if approved, we must continue to build our sales, marketing, managerial and
other non-technical capabilities or make arrangements with third parties to perform these services. We intend to enter into strategic
partnerships with third parties to commercialize our product candidates outside of the United States. We will also consider the option to
enter into strategic partnerships for certain product candidates in the United States.
To date, we have not entered into any strategic partnerships for any of our product candidates. We face significant competition in
seeking appropriate strategic partners, and these strategic partnerships can be intricate and time-consuming to negotiate and document. We
may not be able to negotiate strategic partnerships on acceptable terms, or at all. We are unable to predict when, if ever, we will enter into
any strategic partnerships because of the numerous risks and uncertainties associated with establishing strategic partnerships.
Our strategy for IV meloxicam is to develop a specialty sales force and/or collaborate with third parties to promote the product to
healthcare professionals and third-party payers in the United States. Our future collaboration partners, if any, may not dedicate sufficient
resources to the commercialization of our product candidates or may otherwise fail in their commercialization due to factors beyond our
control. If we are unable to establish effective collaborations to enable the sale of our product candidates to healthcare professionals and in
geographic regions, including the United States, that will not be covered by our own marketing and sales force, or if our potential future
collaboration partners do not successfully commercialize our product candidates, our ability to generate revenues from product sales will
be adversely affected.
If we are unable to negotiate a strategic partnership or obtain additional financial resources for our other product candidates, we
may be forced to curtail the development of them, delay potential commercialization, reduce the scope of our sales or marketing activities
or undertake development or commercialization activities at our own expense. In addition, without a partnership, we will bear all the risk
related to the development of these other product candidates. If we elect to increase our expenditures to fund development or
commercialization activities ourselves, we will need to obtain additional capital, which may not be available to us on acceptable terms, or at
all. If we do not have sufficient funds, we will not be able to bring our other product candidates to market or generate product revenue
from them, which could have a material adverse effect on our business, financial condition and results of operations.
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We are subject to intense compe tition and, if we are unable to compete effectively, IV meloxicam or any of our other
product candidates may not reach their commercial potential.
The market for our product candidates is characterized by intense competition and rapid technological advances. If our product
candidates obtain FDA approval, they will compete with a number of existing and future pharmaceuticals and drug delivery devices
developed, manufactured and marketed by others. We will compete against fully integrated pharmaceutical companies and smaller
companies that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and
private research organizations.
In the post-operative pain relief setting, we believe patients are prescribed injectable acetaminophen, NSAIDs, sodium channel
blockers and opioids, depending on the severity of pain. Specifically, acetaminophen, NSAIDs and sodium channel blockers, we believe,
are prescribed for mild to moderate pain relief, whereas we believe opioids are prescribed for moderate to severe pain relief. While we will
compete with all of these compounds in the post-operative pain setting, we believe IV meloxicam will be prescribed for moderate to severe
pain, competing with opioids and other non-opioid pain treatments. There are a number of pharmaceutical companies that currently market
and/or manufacture therapeutics in the pain relief area, including Johnson & Johnson, Purdue Pharma, L.P., Mallinckrodt plc, Teva
Pharmaceutical Industries, Inc. and Pacira Pharmaceuticals, Inc. and AcelRx Pharmaceuticals, Inc. Purdue is the primary competitor in the
manufacture of opioid therapeutics. Mallinckrodt commercializes an injectable formulation of acetaminophen. Pacira commercializes an
intraoperative formulation of bupivacaine, a sodium channel blocker. Additionally, companies such as Adynxx, Inc., Durect Corporation,
Heron Therapeutics, Inc., Innocoll Holdings plc, Sandoz AG, Trevena, Inc. and Cara Therapeutics, Inc. are currently developing post-
operative pain therapeutics that could compete with us in the future.
More established companies may have a competitive advantage over us due to their greater size, cash flows and institutional
experience. Compared to us, many of our competitors may have significantly greater financial, technical and human resources. As a result
of these factors, our competitors may have an advantage in marketing their approved products and may obtain regulatory approval of their
product candidates before we are able to do so, which may limit our ability to develop or commercialize our product candidates. Our
competitors may also develop drugs that are safer, more effective, more widely used and less expensive than ours, and our competitors
may also be more successful than we are in manufacturing and marketing their products. These advantages could materially impact our
ability to develop and commercialize IV meloxicam and our other product candidates successfully.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being
concentrated among a smaller number of our competitors. Smaller and early‑stage companies may also prove to be significant competitors,
particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting
and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and subject registration for clinical
trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
We anticipate that we will face intense and increasing competition as new drugs enter the market and additional technologies
become available in the pain management and relief space. Finally, the development of different methods for the treatment of acute pain
following surgery could render injectable meloxicam non-competitive or obsolete. These and other risks may materially adversely affect
our ability to attain or sustain profitable operations.
If we obtain approval to commercialize our products outside of the United States, a variety of risks associated with
international operations could materially adversely affect our business.
If our product candidates are approved for commercialization, we may enter into agreements with third parties to market IV
meloxicam or other product candidates outside the United States. We expect that we will be subject to additional risks related to entering
into international business relationships, including:
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different regulatory requirements for drug approvals in foreign countries;
reduced protection for intellectual property rights;
unexpected changes in tariffs, trade barriers and regulatory requirements;
economic weakness, including inflation, or political instability in particular foreign economies and markets;
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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foreign taxes, including withholding of payroll taxes;
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other
obligations incident to doing business in another country;
workforce uncertainty in countries where labor unrest is more common than in the United States;
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
lower pricing of products in our market segment or in general; and
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including
earthquakes, typhoons, floods and fires.
The realization of any of these risks would negatively affect our ability to attain or sustain profitability.
Our relationships with physicians, patients and payers in the U.S. are subject to applicable anti-kickback, fraud and abuse
laws and regulations. Our failure to comply with these laws could expose us to criminal, civil and administrative sanctions,
reputational harm, and could harm our results of operations and financial conditions.
Our current and future operations with respect to the commercialization of IV meloxicam and our other product candidates are
subject to various U.S. federal and state healthcare laws and regulations. These laws impact, among other things, our proposed sales,
marketing, support and education programs and constrain our business and financial arrangements and relationships with third-party payers,
healthcare professionals and others who may prescribe, recommend, purchase or provide IV meloxicam or our other product candidates,
and other parties through which we market, sell and distribute IV meloxicam or our other product candidates. Finally, our current and
future operations are subject to additional healthcare-related statutory and regulatory requirements and enforcement by foreign regulatory
authorities in jurisdictions in which we conduct our business. The laws are described in greater detail in the section below under “Business
Government Regulation — Other Healthcare Laws and Compliance Requirements,” and include, but are not limited to:
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the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and
willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or
in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arranging for or
recommending the purchase, lease or order of, any good or service, for which payment may be made, in whole or in
part, under federal healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual
knowledge of the statute or specific intent to violate it in order to have committed a violation;
the U.S. civil False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens
on behalf of the federal government), prohibits any person from, among other things, knowingly presenting, or causing
to be presented false or fraudulent claims for payment of government funds or knowingly making, using or causing to
be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and
improperly avoiding, decreasing or concealing an obligation to pay money to the U.S. federal government;
HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or
attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false statement, in connection with the delivery of,
or payment for healthcare benefits, items or services by a healthcare benefit program, which includes both government
and privately funded benefits programs; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not
need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
state laws and regulations, including state anti-kickback and false claims laws, that may apply to our business practices,
including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare
items or services reimbursed by any third-party payer, including private insurers; state laws that require pharmaceutical
companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance
guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare
providers and other potential referral sources; and state laws and regulations that require drug manufacturers to file
reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of
value provided to healthcare professionals and entities; and
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the Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations,
requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare,
Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to certain
payments made in the preceding calendar year and other tra nsfers of value to physicians and teaching hospitals, as well
as ownership and investment interests held by physicians and their immediate family members.
The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply
with different compliance or reporting requirements in multiple jurisdictions increases the possibility that a healthcare or pharmaceutical
company may fail to comply fully with one or more of these requirements. Efforts to ensure that our business arrangements with third
parties will comply with applicable healthcare laws and regulations may involve substantial costs. It is possible that governmental
authorities will conclude that our business practices do not comply with applicable fraud and abuse or other healthcare laws and regulations
or guidance. In addition, the complex framework of laws and regulations at the federal and state law are subject to change, which could
lead to non-compliance or additional costs in updating our compliance mechanism to reflect these changes. For example, several states
have enacted laws or regulations affecting or restricting payments that pharmaceutical manufacturers or distributors can make to physicians
and other drug prescribers. If our operations are found to be in violation of any of these laws or any other governmental regulations that
may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion
from government funded healthcare programs, such as Medicare and Medicaid, additional oversight and reporting requirements if we
become subject to a corporate integrity agreement to resolve allegations of non-compliance with these laws and the curtailment or
restructuring of our operations. If any of the physicians or other providers or entities with whom we expect to do business are found not to
be in compliance with applicable laws, they may be subject to the same criminal, civil or administrative sanctions, including exclusions
from government funded healthcare programs. Even if we are not determined to have violated these laws, government investigations into
these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our financial
condition and divert resources and the attention of our management from operating our business.
Any government investigation of alleged violations of law could require us to expend significant time and resources in response
and could generate negative publicity in addition to the aforementioned potential regulatory actions. The occurrence of any event or
penalty described above may inhibit our ability to commercialize IV meloxicam or our other product candidates and generate revenues
which would have a material adverse effect on our business, financial condition and results of operations.
If we are able to successfully commercialize IV meloxicam or our other product candidates and if we participate in but fail
to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program, or other governmental pricing
programs, we could be subject to additional pricing pressures and controls, reimbursement requirements, penalties, sanctions and
fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
If we participate in the Medicaid Drug Rebate Program, and other governmental pricing programs, we will be obligated to pay
certain specified rebates and report pricing information with respect to IV meloxicam or our other product candidates. Pricing and rebate
calculations are complex and are often subject to interpretation by us, governmental or regulatory agencies and the courts. We cannot
assure you that our submissions will not be found by the CMS to be incomplete or incorrect. Governmental agencies may also make
changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts
previously estimated or paid. The Medicaid rebate amount is computed each quarter based on our submission to CMS of our current AMP
and best price for the quarter. If we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of
recalculation of the pricing data, we are obligated to resubmit the corrected data for a period not to exceed twelve quarters from the quarter
in which the data originally were due, and CMS may request or require restatements for earlier periods as well. Such restatements and
recalculations increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate Program. Any
corrections to our rebate calculations could result in an overage or underage in our rebate liability for past quarters, depending on the nature
of the correction. Price recalculations also may affect the ceiling price at which we are required to offer our products to certain covered
entities, such as safety-net providers, under the 340B program, and other similar government pricing programs. These programs are
described in greater detail in the section below under “Business — Government Regulation — Third-Party Payer Coverage and
Reimbursement.”
We will also be liable for errors associated with our submission of pricing data. In addition to retroactive rebates and the potential
for 340B program refunds, if we are found to have knowingly submitted false AMP, or best price information to the government, we may
be liable for civil monetary penalties in the amount of $181,071 per item of false information. If we are found to have made a
misrepresentation in the reporting of our average sales price, we may be liable for civil monetary penalties of up to $13,066 for each
misrepresentation for each day in which the misrepresentation was applied. Our failure to submit monthly/quarterly AMP and best price
data on a timely basis could result in a civil monetary penalty of $18,107 per day for each day the information is
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late beyond the due date. Such failure also could be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to which
we participate in the Medicaid program. In the event that CMS terminates our rebate agreement, federal payments may not be available
under Medicaid for IV meloxicam or our other product candidates. A final regulation imposes a civil monetary penalty of up to $5,000 for
each instance of knowingly and intentionally charging a 340B covered entity more than the 340B ceiling price.
Federal law requires that a company must participate in the FSS pricing program to be eligible to have its products paid for with
federal funds. As part of this program, we would be obligated to make IV meloxicam or our other product candidates available for
procurement on an FSS contract, under which we must comply with standard government terms and conditions and charge a price that is no
higher than the statutory Federal Ceiling Price to four federal agencies (VA, DOD, Public Health Service, and U.S. Coast Guard). The
Federal Ceiling Price is based on the Non-Federal Average Manufacturer Price, which we calculate and report to the VA on a quarterly and
annual basis. If we overcharge the government in connection with our FSS contract or Section 703 Agreement, whether due to a misstated
Federal Ceiling Price or otherwise, we are required to refund the difference to the government. Failure to make necessary disclosures
and/or to identify contract overcharges can result in allegations against us under the U.S. civil False Claims Act and other laws and
regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement action, would be
expensive and time-consuming and could have a material adverse effect on our business, financial condition, results of operations and
growth prospects.
The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to commercialize
IV meloxicam or our other product candidates and affect the prices we may obtain.
The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the
healthcare system that could prevent or delay marketing approval of IV meloxicam or our other product candidates or restrict or regulate
post-approval activities and affect our ability to profitably sell IV meloxicam or our other product candidates for which we obtain
marketing approval. The United States government, state legislatures and foreign governments also have shown significant interest in
implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on
reimbursement and requirements for substitution of generic products for branded prescription drugs.
The Affordable Care Act was intended to broaden access to health insurance, reduce or constrain the growth of healthcare
spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries,
impose new taxes and fees on the health industry and impose additional health policy reforms. These intended reforms are described in
greater detail in the section below under “Business — Government Regulation — United States Healthcare Reform.”
Among the provisions of the Affordable Care Act that have been implemented since enactment and are of importance to the
commercialization of IV meloxicam or our other product candidates are the following:
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an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs or
biologic agents;
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
expansion of healthcare fraud and abuse laws, including the U.S. civil False Claims Act and the Anti-Kickback Statute,
new government investigative powers, and enhanced penalties for noncompliance;
a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale
discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a
condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in
Medicaid managed care organizations;
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated
for drugs that are inhaled, infused, instilled, implanted, or injected;
expansion of eligibility criteria for Medicaid programs;
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
requirements to report certain financial arrangements with physicians and teaching hospitals;
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a requirement to annually report certain information regarding drug samples that manufacturers and distributors provide
to physicians; and
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical
effectiveness research, along with funding for such research.
There have been significant ongoing efforts to modify or eliminate the Affordable Care Act. For example, the Tax Act enacted
on December 22, 2017, repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under
section 5000A of the Internal Revenue Code, commonly referred to as the individual mandate. Further legislative changes to and
regulatory changes under the Affordable Care Act remain possible. It is unknown what form any such changes or any law proposed to
replace the Affordable Care Act would take, and how or whether it may affect our business in the future.
We expect that the Affordable Care Act, as well as other healthcare reform measures that have and may be adopted in the future,
may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved products
and could seriously harm our future revenues. Any reduction in reimbursement from Medicare, Medicaid, or other government programs
may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare
reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products.
Our business, financial condition, and results of operations are subject to risks arising from the international scope of our
manufacturing and supply relationships.
Some of the contract manufacturers of product candidates manufacture and source raw materials outside the United States and we
may, in the future, use manufacturers outside the United States for our other product candidates. As such, we are subject to risks
associated with such international manufacturing relationships, including:
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unexpected changes in regulatory requirements;
problems related to markets with different cultural biases or political systems;
possible difficulties in enforcing agreements in multiple jurisdictions;
longer payment cycles and shipping lead-times;
increased risk relating to the transport of products internationally, including damage to our product, shipment delays
relating to the import or export of our products or the delivery of our products by means of additional third-party
vendors;
difficulties obtaining export or import licenses for our products;
compliance with the U.S. Foreign Corrupt Practices Act and other laws and regulations governing international trade;
fluctuations in foreign currency exchange rates;
changes to U.S. and foreign trade policies, including the enactment of tariffs on goods imported into the United States.;
and
imposition of domestic and international customs and tariffs, withholding or other taxes, including any value added
taxes.
Additionally, we are subject to periodic reviews and audits by governmental authorities responsible for administering
import/export regulations. To the extent that we are unable to successfully defend against an audit or review, we may be required to pay
assessments, penalties, and increased duties on products imported into the United States.
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Risks Related to Our Reliance on Third Parties
Relying on third-parties to manufacture our product candidates exposes us to risks that may delay testing, development,
regulatory approval, commercialization and overall manufacturing of our product candidates.
We currently lack the internal resources to manufacture injectable meloxicam and our other product candidates and we rely on
third-party suppliers and contract manufacturers to manufacture injectable meloxicam. For example, Alkermes is currently our sole
supplier of bulk injectable meloxicam formulation and is the only established supplier of bulk injectable meloxicam formulation. We have
committed to purchase our current requirements of injectable meloxicam formulation from Alkermes, and we have commissioned
dedicated space in Alkermes’ manufacturing facility for the production of bulk injectable meloxicam. Patheon provides sterile fill and
finish services, and we have committed to purchase a certain percentage of our annual requirements of sterile fill and finish services from
Patheon. Our agreement with Patheon also obligates us to a minimum annual order quantity, which, if higher than the commercial demand
for IV meloxicam, if approved, could expose us to increased costs. Although our supply agreement and manufacturing agreements for
injectable meloxicam and our other product candidates allow us to qualify and purchase from an alternative supplier or manufacturer in
certain circumstances, it would be time-consuming and expensive for us to do so, and there can be no assurance that an alternative supplier
could be found. The number of potential manufacturers that have the necessary equipment, expertise and governmental licenses to produce
our product candidates is limited. If we encounter any issues with our contract manufacturers or choose to engage a new supplier or
contract manufacturer for any of our product candidates, we would need to qualify and obtain FDA approval for another contract
manufacturer or supplier as an alternative source for these products and services, which could be costly and cause significant delays.
Our reliance on a limited number of third-party manufacturers also exposes us to the following risks:
•
•
•
•
third-party manufacturers might be unable to manufacture our products in the volume and of the quality required to
meet our clinical and commercial needs, if any;
contract manufacturers may not perform as agreed, and operate their business independently from us. Contract
manufacturers are directly responsible for their own FDA cGMP interactions and we may not be privy to all ongoing
discussions and information concerning products or process unrelated to us. Additionally, contract manufacturers may
not remain in the contract manufacturing business for the time required to successfully produce, store and distribute our
products;
product manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the DEA, and
corresponding state agencies to ensure strict compliance with cGMP and other government regulations and
corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these
regulations and standards and our manufacturers may be found to be in noncompliance with certain regulations, which
may impact our ability to manufacture our drug product candidates and may impact the regulatory status of our product
candidates; and
if any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own,
or may have to share, the intellectual property rights to the innovation.
Each of these risks could delay our preclinical studies and clinical trials, the submission of regulatory applications or the approval,
if any, of our product candidates by the FDA, or the commercialization of our product candidates or could result in higher costs or deprive
us of potential product revenues. If we do not successfully navigate each of these risks in a timely manner or at all, we could experience
significant delays or an inability to successfully develop and commercialize our product candidates, which would materially harm our
business.
If third-party service providers, including carriers, logistics providers and distributors, fail to devote sufficient time and
resources to IV meloxicam or their performance is substandard, our product launch may be delayed and our costs may be higher
than expected.
Our reliance on third-party service providers, including carriers, logistics providers and distributors, exposes us to risks which
could delay or impair the commercialization of IV meloxicam or our other product candidates, result in higher costs, or deprive us of
potential product revenues. Our carriers may experience technical issues relating to the timing and shipment of our products, may
encounter issues in connection with transporting our products internationally, or may become subject to other transit difficulties that could
cause loss or damage to our products, some of which may not be adequately covered under our insurance policies. Our third-party logistic
providers may experience difficulty in providing key services relating to customer service, warehousing, inventory management,
distribution services, contract management, chargeback processing, accounts receivable management, cash application
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and financial management. Our distributors could become unable to sell and deliver IV meloxicam or our other product candidates for
regulatory, compliance and other reasons. Our carriers, logistics providers, distributors and other third-party service providers may not
perform as agreed or may not remain in business for the time required to successfully ship, store, deliver, sell and distribute our products
and we may incur additional cost. Any of our vendors could also default on or terminate their agreements with us, which could delay or
impair the commercialization of IV meloxicam or our other product candidates, which could have a material adverse effect on our business,
financial condition, results of operations and growth prospects.
Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and
cause a loss of customer confidence in us or our products.
Our success depends upon the quality of our products. Quality management plays an essential role in meeting customer
requirements, preventing defects, improving our product candidates and services and assuring the safety and efficacy of our product
candidates. Our future success depends on our ability to maintain and continuously improve our quality management program. A quality
or safety issue may result in adverse inspection reports, warning letters, product recalls or seizures, monetary sanctions, injunctions to halt
manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and
licenses, restrictions on operations or withdrawal of existing approvals and licenses. An inability to address a quality or safety issue in an
effective and timely manner may also cause negative publicity, a loss of customer confidence in us or our future products, which may
result in difficulty in successfully launching product candidates and the loss of sales, which could have a material adverse effect on our
business, financial condition, and results of operations.
Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization.
As we scale up manufacturing of IV meloxicam or our other product candidates and conduct required stability testing, issues may
arise involving product-packaging and third-party equipment malfunctions. These issues may require refinement or resolution in order to
proceed with commercial marketing of IV meloxicam or our other product candidates. In addition, quality issues may arise during scale-up
and validation of commercial manufacturing processes. Any issues in our product or delivery devices could result in increased scrutiny by
regulatory authorities, delays in our regulatory approval process, increases in our operating expenses, or failure to obtain or maintain
approval for our products, which could have a material adverse effect on our business, financial condition, and results of operations.
We use third parties to assist with conducting, supervising and monitoring portions of our nonclinical and clinical studies,
and if those third parties perform in an unsatisfactory manner, it may harm our business.
We use third parties to provide certain manufacturing and operational support and for assistance with clinical trials, data
management and statistical support. While we have agreements governing their activities, we have limited influence over certain of these
third parties’ actual performance. We have previously relied upon such third parties and plan to continue to use third parties to assist with
monitoring and managing data for our ongoing clinical programs for IV meloxicam and our other product candidates, as well as the
execution of nonclinical studies. We control only certain aspects of our third parties’ activities.
We and our contractors are required to comply with GLPs and cGCPs, which are regulations and guidelines enforced by the FDA
and equivalent regulatory authorities in other countries for all of our product candidates in development. The FDA and the equivalent
regulatory authorities in other countries enforce these GLPs and cGCPs through periodic inspections of trial sponsors, principal
investigators and clinical trial sites. If we or our contractors fail to comply with applicable GLPs and cGCPs, the data generated in our
nonclinical studies and clinical trials may be deemed unreliable and the FDA may require us to perform additional studies or clinical trials
before approving our marketing applications. In addition, our clinical trials for our product candidates will require a sufficiently large
number of test subjects to evaluate the safety and effectiveness of each product candidate. Accordingly, if our contractors fail to comply
with these regulations or fail to recruit a sufficient number of patients, we may be required to repeat the clinical trials, which would delay
the regulatory approval process.
These contractors may also have relationships with other commercial entities, including our competitors, for whom they may also
be conducting clinical studies or other drug development activities that could harm our competitive position. While we take steps to protect
our intellectual property, we face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by our
contractors, which may allow our potential competitors to access our proprietary technology. If our contractors do not successfully carry
out their contractual duties or obligations or fail to meet expected deadlines for items within their purview, or if the quality or accuracy of
the clinical data they oversee is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for any
other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or
successfully commercialize IV meloxicam or our other product candidates. As a result, our financial results and the commercial prospects
for IV meloxicam and any future product candidates that we develop would be harmed, our costs could increase, and our ability to generate
revenues could be delayed.
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Risks Related to Our CDMO Segment
Revenues from our development, formulation and manufacturing business are dependent on a small number of
commercial partners, and the loss of any one of these partners, or a decline in their orders, may adversely affect our business.
Our CDMO segment is dependent on our relationships with a small number of commercial partners, with our four largest
customers (Novartis AG, Teva Pharmaceutical Industries, Inc., Pernix and Lannett Company, Inc.) having generated 99% of our revenues
for the year ended December 31, 2018, of which Teva Pharmaceutical Industries, Inc. generated 48% of our revenue under one customer
agreement and Novartis Pharma AG generated 38% of our revenue combined under two separate customer agreements (combined into one
agreement effective January 1, 2019). The Teva contact renews on an annual basis. Other contracts range from three to five years. If any
one or more of these commercial partners fails to renew their contract, faces increasing or new competition in their market, adjusts pricing,
significantly reduces their purchasing volume or experiences financial difficulties such as bankruptcy, our revenues could be adversely
affected. We are actively seeking to develop new customer relationships; but there can be no guarantee that we will be able to expand our
customer base.
Our royalty, profit sharing and manufacturing revenues from this business also depend on the ability of our commercial partners
to effectively market and sell their products to their customers. A commercial partner may choose to devote its efforts to its other products
or reduce or fail to devote the necessary resources to provide effective sales and marketing support for the products we manufacture and
supply. Our commercial partners face competition from other pharmaceutical companies for sales of products to end users. Competition
from sellers of generic drugs is a major challenge for our commercial partners, and the loss or expiration of intellectual property rights for
the products we manufacture can have a significant adverse effect on their sales volume. This and any other significant reduction, delay or
cancellation of orders from our commercial partners could adversely affect our revenues.
In addition, the financial covenants in our credit agreement with Athyrium include minimum revenue targets for our CDMO
segment, and any significant reduction, delay or cancellation of orders from our commercial partners may cause us to fail to meet such
targets, which may result in an event of default under the credit agreement with Athyrium and could have a material adverse effect on our
business, financial condition and results of operation.
We are subject to risks related to large-scale commercial manufacturing.
Manufacturing pharmaceuticals, especially in large quantities, is complex. The products we manufacture for our commercial
partners require several manufacturing steps and may involve complex techniques to assure quality and sufficient quantity. Our
manufactured products must be made consistently and in compliance with a clearly defined manufacturing process. Slight deviations
anywhere in the manufacturing process, including obtaining materials, equipment malfunctions, filling, labeling, packaging, storage,
shipping, regulatory compliance, quality control and testing, some of which all pharmaceutical manufacturing companies experience from
time to time, may result in lot failures, delay in the release of lots, product recalls or spoilage. Success rates can vary dramatically at
different stages of the manufacturing process, which can lower yields and increase costs.
In addition, some of the raw materials needed for the manufacture of our products are currently available from a single source or a
limited number of qualified sources of these products. Although we attempt to acquire an adequate inventory of such materials, establish
alternative sources and/or negotiate long-term supply arrangements, there is no certainty that we will be able to obtain long-term supplies of
our manufacturing materials in the future. We may also experience deviations in the manufacturing process or interruptions in our supply
chain that may take significant time and resources to resolve and, if unresolved, may affect manufacturing output and/or cause us to fail to
satisfy customer orders or contractual commitments or result in litigation or regulatory action.
Our manufacturing facilities also require specialized personnel and are expensive to operate and maintain. Any suspension of the
sale of products of our commercial partners to be manufactured in our facilities may cause operating losses as we continue to operate the
facilities and retain specialized personnel. In addition, any interruption in manufacturing could result in delays in meeting our contractual
obligations and could damage our relationships with our commercial partners, including the loss of manufacturing and supply rights, which
could have a material adverse effect on our business, financial condition, and results of operations.
Our CDMO segment is highly-leveraged.
As of December 31, 2018, we had an outstanding balance under our credit agreement with Athyrium of $70 million, which is
secured primarily by the assets of our CDMO segment. Our credit agreement with Athyrium contains certain financial and other
covenants, including a minimum liquidity requirement and a trailing four-quarter revenue requirement and maximum leverage ratios. In
addition, it includes limitations on, among other things, additional indebtedness, acquisitions and certain investments. The credit agreement
provides for certain mandatory prepayment events, including with respect to the proceeds of asset sales, extraordinary receipts, debt
issuances and other specified events, based on the terms of the credit agreement with Athyrium. Any failure to comply
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with the terms, covenants and conditions may result in an event of default under such agreement, which could allow Athyrium to foreclose
on the assets of the CDMO segment, which could have a material adverse effect on our business, financial condition and results of
operation. In addition, any sale of our CDMO segment would require repayment of the Athyrium credit facility, including and prepayment
penalties applicable, which could significantly decrease the proceeds of any such sale, which could have a material adverse effect on our
financial condition.
Our development and formulation services projects are typically for a shorter term than our manufacturing projects, and
any failure by us to maintain an adequate volume of development and formulation services projects, including due to lower than
expected success rates of the products for which we provide services, could have a material adverse effect on our business, results of
operations and financial condition.
Our pharmaceutical development services business contracts are generally shorter in term than our manufacturing contracts and
typically require us to provide development services within a designated scope. Since our development and formulation services focus on
products that are still in developmental stages, their viability depends on the ability of such products to reach their respective subsequent
development phases. In many cases, such products do not reach subsequent development phases and, as a result, the profitability of the
related pharmaceutical development service project may be limited. Even if a customer wishes to proceed with a project, the product we
are developing on such customer’s behalf may fail to receive necessary regulatory approval or may have its development hindered by other
factors, such as the development of a competing product.
If we are unable to continue to obtain new projects from existing and new customers, our development and formulation services
business could be adversely affected. Furthermore, although our development and formulation services business may act as a pipeline for
our manufacturing services business, we cannot predict the conversion rate of our development and formulation services projects to
commercial manufacturing services projects, or how successful we will be in winning new projects that lead to a viable product. As such,
an increase in the turnover rate of our development and formulation services projects may not benefit our manufacturing services business
at a later time. In addition, the discontinuation of a project as a result of our failure to satisfy a customer’s requirements may also affect our
ability to obtain future projects from such customer, as well as from new customers. Any failure by us to maintain a high volume of
development and formulation services projects could have a material adverse effect on our business, results of operations and financial
condition.
If we fail to meet the stringent requirements of governmental regulation in the manufacture of pharmaceutical products,
we could incur substantial costs and a reduction in revenues.
We are required to maintain compliance with cGMP, and our manufacturing facilities are subject to inspections by the FDA and
other global regulators to confirm such compliance. Changes of suppliers or modifications of methods of manufacturing may require
amending our application(s) to the FDA and acceptance of the change by the FDA prior to release of our manufactured products. Because
we produce multiple products at our manufacturing facilities, there are increased risks associated with cGMP compliance. On January 24,
2018, following a six-day inspection of our primary manufacturing facility, the FDA issued a Form 483 containing four observations
relating to good documentation practices and data integrity. We have promptly responded to these observations as a part of our ongoing
obligations under the FDA’s quality system regulation and have implemented corrective and preventative actions to ensure these type of
observations do not occur in the future. While we remain committed to continuous improvement and strengthening our quality system and
ensuring that all aspects of the system are in full compliance, we can provide no assurance that we will not encounter future inspections
resulting in observations not acceptable by the FDA.
Our inability to demonstrate ongoing cGMP compliance could require us to engage in additional lengthy and expensive
remediation efforts, withdraw or recall products and/or interrupt commercial supply of any products. Any delay, interruption or other issue
that arises in the manufacture, fill/finish, packaging, or storage of any drug product as a result of a failure of our facilities to pass any
regulatory agency inspection or maintain cGMP compliance could significantly impair our relationships with our commercial partners,
which would substantially harm our business, prospects, operating results and financial condition. Any ongoing or additional findings of
non-compliance could also increase our costs and cause us to lose revenue from manufactured products, which could be seriously
detrimental to our business, prospects, operating results and financial condition.
Additionally, our manufacturing activities are subject to the Controlled Substances Act and the regulations of the
DEA. Accordingly, we must adhere to a number of requirements with respect to controlled substances, including registration,
recordkeeping and reporting requirements; labeling and packaging requirements; security controls, procurement and manufacturing quotas;
and certain restrictions on refills. Failure to maintain compliance with applicable requirements can result in an enforcement action that
could have a material adverse effect on our business, financial condition, operating results and cash flows. The DEA may seek civil
penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In certain circumstances, violations
could result in criminal proceedings.
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We manufacture opioid products, which are subject to additional regulation by state and federal law enforcement and
other regulatory agencies.
We manufacture opioid products, including Zohydro ER, an extended-release opioid treatment, containing hydrocodone. The U.S.
government and state legislatures have prioritized combatting the growing misuse and addiction to opioids such as hydrocodone and have
enacted legislation and regulations as well as other measures intended to fight the opioid epidemic. Addressing prescription drug abuse is a
priority for the current U.S. administration and the FDA and is part of a broader initiative led by the Department of Health and Human
Services. Overall, there is greater scrutiny of entities involved in the manufacture, sale and distribution of opioids. These initiatives,
existing regulations, and any negative publicity related to opioids may have a material impact on our business and our ability to
manufacture opioid products.
Opioids are controlled substance regulated by the DEA. The amount of Schedule II substances that can be obtained is limited by
the CSA and DEA regulations. For 2019, the DEA has proposed decreased manufacturing quotas for the six most frequently misused
opioids, including hydrocodone, by an average of 10% as compared to the 2018 quotas. If limited supply of opioids impacts demand for
products of our partners, our revenues may be adversely impacted. In addition to DEA regulations, the U.S. government and states have
enacted other laws that seek to promote improved monitoring of opioids and to increase funding for research and development of non-
addictive painkillers. Legislation has also been proposed that would further limit the ability to sell and prescribe opioids. These efforts may
result in an additional reduction of demand for opioid products or government action against us if we fail to comply with these laws and
could have a material adverse effect on our business.
We may not be able to successfully offer new services.
In order to successfully compete, we will need to offer and develop new services. Without the timely introduction of enhanced or
new services, our services and capabilities may become obsolete over time, in which case, our revenues and operating results would
suffer. The related development costs may require a substantial investment before we can determine their commercial viability, and we
may not have the financial resources to fund such initiatives.
In addition, the success of enhanced or new services will depend on several factors, including but not limited to our ability to:
•
•
•
properly anticipate and satisfy customer needs, including increasing demand for lower cost services;
enhance, innovate, develop and manufacture new offerings in an economical and timely manner;
differentiate our deliverables from competitors’ offerings;
• meet quality requirements, authorization requirements, and other regulatory requirements of government agencies;
•
•
obtain valid and enforceable intellectual property rights; and
avoid infringing the proprietary rights of third parties.
Even if we were to succeed in creating enhanced or new services, those services may not result in commercially successful
offerings or may not produce revenues in excess of the costs of development and capital investment and may be quickly rendered obsolete
by changing customer preferences or by technologies or features offered by our competitors. In addition, innovations may not be accepted
quickly in the marketplace due to, among other things, entrenched patterns of clinical practice, the need for regulatory clearance and
uncertainty over market access or government or third-party reimbursement. If we are not able to offer new services and effectively
compete, our business, financial condition, and results of operations could be negatively impacted.
Technological change may cause our offerings to become obsolete over time. A decrease in our customers’ purchases of
our offerings could have a material adverse effect on our business, results of operations and financial condition.
The healthcare industry is characterized by rapid technological change. Demand for our services may change in ways that we
may not anticipate because of evolving industry standards or as a result of evolving customer needs that are increasingly sophisticated and
varied or because of the introduction by competitors of new services and technologies. In addition, we require capital and resources to
support the maintenance and improvement of our facilities, including replacing or repairing aging production equipment and updating
overall facility master plans. If we are unable to maintain and improve our facilities, we may experience unscheduled equipment downtime
and unpredicted machinery failure and become unable to supply our customers with products or services which may affect business
continuity. Any such incident or disruption in business continuity could have a material adverse effect on our business, results of
operations and financial condition.
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We may be adversely affected by natural disasters or other events that disrupt our business operations, and our business
continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Our manufacturing facilities are located in Gainesville, Georgia, where natural disasters or similar events, like hurricanes,
blizzards, tornadoes, fires, floods, earthquakes or explosions or large-scale accidents or power outages, could severely disrupt our
operations and have a material adverse effect on our business, prospects, results of operations and financial condition. If a disaster, power
outage or other event occurred that prevented us from using all or a significant portion of our Gainesville facilities, damaged critical
infrastructures, such as manufacturing resource planning and enterprise quality systems, or otherwise disrupted operations at that location,
it may be difficult or, in certain cases, impossible for us to continue our development, formulation and manufacturing business for a
substantial period of time, which could have a material adverse effect on our business, financial condition, and results of operations.
Currently, we maintain insurance coverage against damage to our property and equipment, and to cover business interruption
expenses, in an amount we believe is sufficient for our development, formulation and manufacturing operations. However, there can be no
assurance that such insurance will continue to be available on acceptable terms or that such insurance will provide adequate protection
against actual losses. Even if we maintain adequate insurance coverage, claims could have a material adverse effect on our financial
condition, liquidity and results of operations and on our ability to obtain suitable, adequate or cost-effective insurance in the future.
We must comply with environmental and health and safety laws and regulations, which can be expensive and restrict how
we do business.
In connection with our CDMO segment, we are subject to federal, state and local laws, rules, regulations and policies concerning
the environment and the health and safety of our employees. Although we believe that we have complied with the applicable laws,
regulations and policies in all material respects and have not been required to correct any material noncompliance, we may be required to
incur significant costs to comply with environmental and health and safety regulations in the future. Current or future laws and regulations
may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in
substantial fines, penalties or other sanctions, which could have a material adverse effect on our business, financial condition, and results of
operations.
In addition, our business conducted by our CDMO segment involves the use, generation and disposal of hazardous materials,
including chemicals, solvents, agents and biohazardous materials. As a result, we are subject to federal, state and local laws, rules,
regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of
certain materials, biological specimens and wastes. Although we believe that our safety procedures for storing, handling and disposing of
such materials comply with the standards prescribed by those regulations, we cannot completely eliminate the risk of accidental
contamination or injury from these materials. We currently contract with third parties to dispose of these substances that we generate, and
we rely on these third parties to properly dispose of these substances in compliance with applicable laws and regulations. If these third
parties do not properly dispose of these substances in compliance with applicable laws and regulations, we may be subject to legal action by
governmental agencies or private parties for improper disposal of these substances. The costs of defending such actions and the potential
liability resulting from such actions are often very large. In the event we are subject to such legal action or we otherwise fail to comply
with applicable laws and regulations governing the use, generation and disposal of hazardous materials and chemicals, we could be held
liable for any damages that result, and any such liability could exceed our resources. In addition, although we maintain workers’
compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees, including those resulting from
the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. If we become subject to any
of the foregoing liabilities, our business, financial condition, and results of operations could be materially adversely impacted.
Risks Related to Our Business Operations and Industry
We are subject to securities class action litigation, which is expensive, can divert management attention, and, if resolved
unfavorably, could expose us to significant liabilities.
On May 24, 2018, we announced the receipt from the FDA of a CRL for our NDA for IV meloxicam. The announcement was
followed by a substantial decrease in the trading price of our common stock on the Nasdaq Capital Market. On May 31, 2018, a securities
class action lawsuit was filed against us and certain of our officers and directors for alleged violations of Section 10(b) and 20(a) of the
Exchange Act and Rule 10(b)(5) promulgated thereunder, based on statements made by us concerning the NDA for IV meloxicam. The
complaint seeks unspecified damages, interest, attorneys’ fees and other costs. On December 10, 2018, lead plaintiff filed an amended
complaint that asserted the same claims and sought the same relief but included new allegations and named additional officers and directors
as defendants. On February 8, 2019, we filed a motion to dismiss the amended complaint in its
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entirety. We believe that the lawsuit is without merit and intend to vigorously defend against it. The lawsuit is in the early stages and, at
this time, no assessment can be made as to its likely outcome or whether the outcome will be material to us. This litigation could result in
substantial costs and a diversion of management’s resources and attention. In addition, any adverse determination could expose us to
significant liabilities, which could have a material adverse effect on our business, financial condition, and results of operations.
We may be subject to additional litigation or government investigations for a variety of claims, which could adversely
affect our operating results, harm our reputation or otherwise negatively impact our business.
In addition to our ongoing securities class action litigation, we may be subject to other litigation or government investigations.
These may include claims, lawsuits, and proceedings involving product liability, labor and employment, wage and hour, commercial and
other matters. The outcome of any litigation or government investigation, regardless of its merits, is inherently uncertain. Any lawsuits or
government investigations, and the disposition of such lawsuits and government investigations, could be time-consuming and expensive to
resolve and divert management attention and resources. Any adverse determination related to litigation or government investigations could
adversely affect our operating results, harm our reputation or otherwise negatively impact our business. In addition, depending on the
nature and timing of any such dispute, a resolution of a legal matter or government investigation could materially affect our future operating
results, our cash flows or both.
Our future success depends on our ability to retain and have the full attention of our key executives as well as to attract,
retain and motivate other qualified personnel.
We are highly dependent on the principal members of our executive team and, in particular, the services of Gerri A. Henwood,
our President and Chief Executive Officer, the loss of whose services would adversely impact the achievement of our objectives. We have
entered into employment agreements with each of our executive officers. Recruiting and retaining qualified employees for our business,
including scientific and technical personnel, will also be critical to our success. There is currently a shortage of skilled executives in our
industry, which is likely to continue. As a result, competition for skilled personnel is intense and the turnover rate can be high. We may
not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical companies for
individuals with similar skill sets. In addition, failure to succeed in clinical studies may make it more challenging to recruit and retain
qualified personnel. The inability to recruit or loss of the services of any executive or key employee could impede the progress of our
research, development and commercialization objectives.
We will need to continue to grow the size of our organization, and we may experience difficulties in managing this growth.
We have begun to grow the size of our managerial, operational, sales, marketing, financial and other resources as we prepare for
the potential approval and commercialization of IV meloxicam and the ongoing development of our other product candidates. However,
our management, personnel and systems currently in place may not be adequate to support this growth or assist us with the potential growth
into a commercial stage pharmaceutical company. As we continue to expand, we may not be able to effectively manage the expansion of
our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss
of employees and reduced productivity among remaining employees. Additional future growth could require significant capital
expenditures and may divert financial resources from other projects, such as the development of our existing or future product
candidates. Future growth would impose significant added responsibilities on members of management, including:
• managing the commercialization of any FDA‑approved product candidates;
•
•
overseeing our ongoing clinical trials effectively;
identifying, recruiting, maintaining, motivating and integrating additional employees, including any additional sales and
marketing personnel engaged in connection with the commercialization of any approved product, on terms that are
favorable to us if at all;
• managing our internal development efforts effectively while complying with our contractual obligations to licensors,
licensees, contractors and other third parties;
•
•
improving our managerial, development, operational and financial systems and procedures; and
expanding our facilities.
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As our operations expand, we will need to manage additional relationships with various collaboration partners, suppliers and other
third parties. Our future financial performance and our ability to commercialize our product candidates and to compete effec tively will
depend, in part, on our ability to manage any future growth effectively. To that end, we must be able to manage our development efforts
and clinical trials effectively and hire, train and integrate additional management, administrative and sales and marketing personnel. We
may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our
company.
We may acquire other assets or businesses, or form collaborations or make investments in other companies or
technologies, that could have a material adverse effect on our operating results, dilute our shareholders’ ownership, increase our
debt or cause us to incur significant expense.
As part of our business strategy, we may pursue acquisitions of assets, including preclinical, clinical or commercial stage products
or product candidates, businesses or strategic alliances and collaborations, to expand our existing technologies and operations. We may not
identify or complete these transactions in a timely manner, on a cost‑effective basis, or at all, and we may not realize the anticipated
benefits of any such transaction, any of which could have a material adverse effect on our financial condition, results of operations and cash
flows. We may not be able to find suitable acquisition candidates, and if we make any acquisitions, we may not be able to integrate these
acquisitions successfully into our existing business and we may incur additional debt or assume unknown or contingent liabilities in
connection therewith. Integration of an acquired company or assets may also disrupt ongoing operations, require the hiring of additional
personnel and the implementation of additional internal systems and infrastructure, especially the acquisition of commercial assets, and
require management resources that would otherwise focus on developing our existing business. On April 10, 2015, we completed the
acquisition from Alkermes of certain assets, including the worldwide rights to injectable meloxicam and the development, formulation and
manufacturing business that comprised our CDMO segment, which we refer to as the Gainesville Transaction. While we have successfully
integrated the assets that we purchased in the Gainesville Transaction into our infrastructure, we cannot assure that the experience would
be the same for future acquisitions. We may not be able to find suitable strategic alliances or collaborators or identify other investment
opportunities, and we may experience losses related to any such investments.
To finance any acquisitions or collaborations, we may choose to issue debt or shares of our common or preferred stock as
consideration. Any such issuance of shares would dilute the ownership of our shareholders. If the price of our common stock is low or
volatile, we may not be able to acquire other assets or companies or fund a transaction using our stock as consideration. Alternatively, it
may be necessary for us to raise additional funds for acquisitions through public or private financings. Additional funds may not be
available on terms that are favorable to us, or at all.
Our employees, partners, independent contractors, principal investigators, consultants, vendors and contract research
organizations may engage in misconduct or other improper activities, including noncompliance with regulatory standards and
requirements.
We are exposed to the risk that our employees, partners, independent contractors, principal investigators, consultants, vendors and
CROs may engage in fraudulent or other illegal activity with respect to our business. Misconduct by these employees could include
intentional, reckless and/or negligent conduct or unauthorized activity that violates: (1) FDA or DEA regulations, including those laws
requiring the reporting of true, complete and accurate information to the FDA; (2) manufacturing standards; (3) federal and state healthcare
fraud and abuse laws and regulations; or (4) laws that require the true, complete and accurate reporting of financial information or
data. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials, or illegal
misappropriation of drug product, which could result in regulatory sanctions and serious harm to our reputation. Any incidents or any other
conduct that leads to an employee receiving an FDA debarment could result in a loss of business from our partners and severe reputational
harm. We have adopted a Code of Business Conduct and Ethics, but it is not always possible to identify and deter employee misconduct,
and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or
in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws
or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those
actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages,
monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages,
reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability
to operate our business, operating results and financial condition.
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We face potential product liability claims, and, if successful claims are brought against us, we may incur substantial
liability.
The use of our product candidates in clinical studies and the sale of any products for which we obtain marketing approval exposes
us to the risk of product liability claims. In addition, our CDMO segment exposes us to potential toxic tort and other types of product
liability claims that are inherent in the manufacture of pharmaceutical products. Product liability claims might be brought against us by
consumers, health care providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. If we
cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or
eventual outcome, product liability claims may result in:
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impairment of our business reputation and negative media attention;
withdrawal of clinical study participants;
termination of clinical trial sites;
costs due to related litigation;
distraction of management’s attention from our primary business;
decreased demand for our manufacturing services or loss of any of our commercial partners;
substantial monetary awards to patients or other claimants;
the inability to commercialize our product candidates;
decreased demand for our product candidates, if approved for commercial sale; and/or
increased scrutiny and potential investigation by, among others, the FDA, the Department of Justice, the Office of
Inspector General of the U.S. Department of Health and Human Services, State Attorneys General, members of
Congress and the public.
Our current product liability insurance coverage may not be sufficient to reimburse us for any expenses or losses we may
suffer. Moreover, insurance coverage is becoming increasingly expensive and, in the future, we may not be able to maintain insurance
coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. If and when we obtain marketing approval
for our product candidates, we intend to expand our insurance coverage to include the sale of commercial products; however, we may be
unable to obtain product liability insurance on commercially reasonable terms or in adequate amounts.
On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated AEs. A
successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our
insurance coverage, could adversely affect our results of operations and business.
We incur increased costs and demands upon our management as a result of complying with the laws and regulations
affecting public companies, which could harm our operating results.
We are a public company and, as such, we incur significant legal, accounting and other expenses, including costs associated with
public company reporting requirements. We incur costs associated with current corporate governance requirements, including certain of
the requirements under Section 404 and other provisions of the Sarbanes-Oxley Act of 2002, as well as rules implemented by the SEC and
the NASDAQ Capital Market, the stock exchange on which our common stock is listed. If we fail to comply with current corporate
governance requirements, our business may be negatively affected, including by having our common stock delisted from the NASDAQ
Capital Market.
The expenses incurred by public companies for reporting and corporate governance purposes have increased dramatically in recent
years. We expect these rules and regulations to continue to substantially increase our legal and financial compliance costs and to make
some activities more time-consuming and costly. We are unable to currently estimate these costs with any degree of certainty. We also
expect that these rules and regulations may make it difficult and expensive for us to continue to maintain director and officer liability
insurance, and if we are able to maintain such insurance, we may be required to accept reduced policy limits and coverage or incur
substantially higher costs to obtain the same or similar coverage available to privately-held companies. As a result, it may be more
difficult for us to attract and retain qualified individuals to serve on our board of directors, or the board, or as our executive officers, which
could have a material adverse effect on our business.
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The security of our information technology systems may be compromised in the event of system failures, unauthorized
access, cyberattacks or a deficiency in our cybersecurity, and confidential information, including non-public personal information
that we maintain, could be improperly disclosed.
We rely extensively on information technology and systems including internet sites, data hosting, physical security, and software
applications and platforms. Despite our security measures, our information technology systems, some of which are managed by third
parties, may be susceptible to damage, disruptions or shutdowns due to computer viruses, attacks by computer hackers, failures during the
process of upgrading or replacing software, power outages, user errors or catastrophic events. A significant breakdown, invasion,
corruption, destruction or interruption of critical information technology systems, by our employees, others with authorized access to our
systems or unauthorized persons could negatively impact or interrupt operations. For example, the loss of data from completed or ongoing
clinical trials for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to
recover or reproduce the data. The use of technology, including cloud-based computing, creates opportunities for the unintentional
dissemination or intentional destruction of confidential information stored in our systems or our third-party systems. We could also
experience a business interruption, theft of confidential information or reputational damage from malware or other cyberattacks, which may
compromise our systems or lead to data leakage, either internally or at our third-party providers.
As part of our business, we maintain large amounts of confidential information, including non-public personal information on
patients and our employees. The maintenance of such information is governed by various rules and regulations in the jurisdictions in which
we conduct our business, including by the General Data Privacy Regulation, or GDPR, in the European Union. Breaches in security, either
internally or at our third-party providers, could result in the loss or misuse of this information, which could, in turn, result in potential
regulatory actions or litigation, including material claims for damages, interruption to our operations, damage to our reputation or otherwise
have a material adverse effect on our business, financial condition and operating results. Although we believe we have appropriate
information security policies and systems in place in order to prevent unauthorized use or disclosure of confidential information, including
non-public personal information, there can be no assurance that such use or disclosure will not occur.
Any such business interruption, theft of confidential information or reputational damage from malware or other cyberattacks, or
violation of personal information laws, could have a material adverse effect on our business, financial condition, and results of operations.
If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions
(which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our
operating results and business.
We are subject to laws and regulations that address privacy and data security of patients who use our product candidates in the
United States and in states in which we conduct our business. In the United States, numerous federal and state laws and regulations,
including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g.,
Section 5 of the Federal Trade Commission Act) govern the collection, use, disclosure, and protection of health-related and other personal
information. For instance, HIPAA imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the
privacy, security and transmission of individually identifiable health information and imposes notification obligations in the event of a
breach of the privacy or security of individually identifiable health information on entities subject to HIPAA and their business associates
that perform certain activities that involve the use or disclosure of protected health information on their behalf. Certain of these laws and
regulations are described in greater detail in the section below under “Business — Government Regulation — Other Healthcare Laws and
Compliance Requirements.” Failure to comply with applicable data protection laws and regulations could result in government enforcement
actions and create liability for us, which could include civil and/or criminal penalties, as well as private litigation and/or adverse publicity
that could negatively affect our operating results and business.
Risks Related to Our Intellectual Property
We own or license numerous pending patent applications and issued patents in the United States. If our pending patent
applications fail to issue or if our issued patents expire or are successfully opposed, invalidated, or rendered unenforceable, our
business will be adversely affected.
Our commercial success will depend in part on obtaining and maintaining patent protection for our product candidates, as well as
successfully defending our current and future patents against third-party challenges. To protect our proprietary technology, we intend to
rely on patents, and we may also rely on other intellectual property protections, including trade secrets, nondisclosure agreements and
confidentiality provisions.
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There can be no assurance that our pending patent applications will result in issued patents. As of December 31, 2018, we own
patents and patent applications for injectable meloxicam that cover compositions, including compositions produced using NanoCrystal®
technology, a method of making and method of treating. These issued patents expire in 2022 in the United States. We also in-license from
Alkermes, on a perpetual royalty-free basis, composition and methods of making patents, one of which we anticipate to be Orange-Book
listable, and patent applications (specifically directed to the prevention of flake like substances) which expire in 2030. As of December 31,
2018, we own or license a total of eight issued U.S. patents and nine U.S. pending patent applications, and 59 issued foreign patents
(including European validation countries) and six pending foreign applications related to meloxicam. As of December 31, 2018, we own
seven issued U.S. patents relating to Zohydro-ER®, two of which expire on November 1, 2019, and five of which expire on September 12,
2034. We also own Canadian patent applications that are pending relating to the same technology, which we license to our commercial
partner, Paladin Labs Inc., in Canada. As of December 31, 2018, we are the owner of record of one issued U.S. patent and 25 issued
foreign patents, including European validation countries, to Dex. In addition, we have licensed four patent families containing several U.S.
and foreign issued patents and pending applications related to neuromuscular blocking agents from Cornell University. The patent
applications that we have filed and have not yet been granted may fail to result in issued patents in the United States or foreign
countries. Even if the patents do successfully issue, third parties may challenge the patents or the inventorship thereof, which can lead to
an issued patent being found invalid, unenforceable or can otherwise alter the ownership of the patents.
The issuance of any patent is not a certainty. Unless and until our pending applications issue, their protective scope is impossible
to determine. It is impossible to predict whether or how many of these applications will result in issued patents and patents that issue may
be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of patent exclusivity or
freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which may limit our ability to
prevent others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of
our technology and products. In addition, upon expiration of a patent, we may be limited in our ability to prevent others from using or
commercializing subject matter covered by the expired patents. As a result, our owned and licensed patent portfolio may not provide us
with sufficient rights to exclude others from commercializing products similar or identical to ours.
The patent position of biotechnology and pharmaceutical companies, including us, generally is highly uncertain, involves
complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries
may not protect our rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability
of methods of treatment of the human body more than United States law does. Publications of discoveries in the scientific literature often
lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18
months after the first filing, or in some case at all. Therefore, we cannot know with certainty whether we or our licensors were the first to
make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our licensors were the first to
file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent
rights are highly uncertain. In addition, we may not be aware of particular prior art publications that may have an impact on patentability
or enforceability. Further, the examination process may require us or our licensors to narrow the claims for our pending patent applications
due to, for example, such prior art publications, which may limit the scope of patent protection that may be obtained if these applications
issue. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole
or in part, or which effectively prevent others from commercializing competitive technologies and products. Furthermore, our pending
applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues
from such applications. Because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, issued
patents that we own or have licensed from third parties may be challenged in the courts or patent offices in the U.S. and abroad. Such
challenges may result in the loss of patent protection, the narrowing of claims in such patents, and/or the invalidity or unenforceability of
such patents, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or
limit the duration of the patent protection for our technology and products. Changes in either the patent laws or interpretation of the patent
laws in the United States and other countries may diminish the value of patents or narrow the scope of patent protection.
Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of patent applications and the
enforcement or defense of issued patents. The Leahy Smith America Invents Act, or the Leahy Smith Act, enacted in September 2011,
brought significant changes to the U.S. patent system. These include provisions that affect the way patent applications are prosecuted and
may also affect patent litigation. The United States Patent Office continues to develop and implement new regulations and procedures to
govern administration of the Leahy Smith Act, and many of the substantive changes to patent law associated with the Leahy Smith Act
became effective on March 16, 2013. The Leahy Smith Act and its implementation could increase the uncertainties and costs surrounding
the prosecution of our patent applications and the enforcement or defense of our issued patent, all of which could have a material adverse
effect on our business and financial condition.
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Litigation involving patents, patent applications and other proprietary rights is expensive and time-consuming. If we are
involved in such litigation, it could cause delays in bringing our product candidates to market and interfere with our business.
Our commercial success depends in part on not infringing patents and proprietary rights of third parties. Although we are not
currently aware of litigation or other proceedings or third-party claims of intellectual property infringement related to our product
candidates, the pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights.
As we enter our target markets, it is possible that competitors or other third parties will claim that our products and/or processes
infringe their intellectual property rights. These third parties may have obtained and may in the future obtain patents covering products or
processes that are similar to, or may include compositions or methods that encompass our technology, allowing them to claim that the use
of our technologies infringes these patents. If such third-party patent is listed in the Orange Book, we would be required to file a
certification, known as a Paragraph IV certification, that we are not infringing the patent, or that the patent is invalid. The third-party
would then have 45 days to file a patent infringement lawsuit against us, and if so brought, we could be subject to a stay of up to 30 months
(unless before that time the patent expires or is judged to be invalid or not infringed), in which we would be unable to have our 505(b)(2)
application approved.
In a patent infringement claim against us, we may assert, as a defense, that we do not infringe the relevant patent claims, that the
patent is invalid or both. The strength of our defenses will depend on the patents asserted, the interpretation of these patents and/or our
ability to invalidate the asserted patents. However, we could be unsuccessful in advancing non-infringement and/or invalidity arguments in
our defense. In the United States, issued patents enjoy a presumption of validity, and the party challenging the validity of a patent claim
must present clear and convincing evidence of invalidity, which is a high burden of proof. Conversely, the patent owner need only prove
infringement by a preponderance of the evidence, which is a low burden of proof.
If we were found by a court to have infringed a valid patent claim, we could be prevented from using the patented technology or
be required to pay the owner of the patent for the right to license the patented technology. If we decide to pursue a license to one or more of
these patents, we may not be able to obtain a license on commercially reasonable terms, if at all, or the license we obtain may require us to
pay substantial royalties or grant cross licenses to our patent rights. For example, if the relevant patent is owned by a competitor, that
competitor may choose not to license patent rights to us. If we decide to develop alternative technology, we may not be able to do so in a
timely or cost-effective manner, if at all.
In addition, because patent applications can take years to issue and are often afforded confidentiality for some period of time,
there may currently be pending applications, unknown to us, that later result in issued patents that could cover one or more of our products.
It is possible that we may in the future receive, particularly as a public company, communications from competitors and other
companies alleging that we may be infringing their patents, trade secrets or other intellectual property rights, offering licenses to such
intellectual property or threatening litigation. In addition to patent infringement claims, third parties may assert copyright, trademark or
other proprietary rights against us. We may need to expend considerable resources to counter such claims and may not be able to be
successful in our defense. Our business may suffer if a finding of infringement is established.
Generic competitors can challenge the U.S. patents protecting our product candidates by filing an ANDA or an NDA for a
generic or a modified version of our product candidates and negatively affect our competitive position.
Separate and apart from the protection provided under the U.S. patent laws, drug candidates may be subject to the provisions of
the Hatch- Waxman Act, which may provide drug candidates with either a three- or five-year period of marketing exclusivity following
receipt of FDA approval. The Hatch-Waxman Act prohibits the FDA from accepting the filing of an ANDA application (for a generic
product) or a 505(b)(2) NDA (for a modified version of the product) for three years for active drug ingredients previously approved by the
FDA or for five years for active drug ingredients not previously approved by the FDA.
There is an exception, however, for newly approved molecules that allows competitors to challenge a patent beginning four years
into the five-year exclusivity period by alleging that one or more of the patents listed in the FDA’s list of approved drug products are
invalid, unenforceable and/or not infringed and submitting an ANDA for a generic version of a drug candidate. This patent challenge is
commonly known as a Paragraph IV certification. Within the past several years, the generic industry has aggressively pursued approvals of
generic versions of innovator drugs at the earliest possible point in time.
If a generic company is able to successfully challenge the patents covering drug candidates by obtaining FDA approval for an
ANDA, the generic company may choose to launch a generic version of a drug candidate. Any launch of a generic version of our drug
candidates prior to the expiration of patent protection will have a material adverse effect on our revenues and our results of operations.
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We and our commercial partners have been involved in Paragraph IV litigation in the United States involving some of our patents
in respect of Zohydro ER®. These litigations have been, and any other Paragraph IV litigation may be, expensive, distracting to
management and protracted. Although we and our commercial partners have successfully settled our Paragraph IV litigation, any future
Paragraph IV litigation could result in new or additional generic competition to Zohydro ER®. The introduction of a generic version of
Zohydro ER® could cause a reduction in revenue for our CDMO segment, which could have a material adverse effect on our business,
results of operations, financial condition and prospects. In addition, we were previously involved in an interference in front of the United
States Patent and Trademark Office with another party, which involved a patent application relating to Zohydro ER®, for which we
ultimately were successful on appeal. However, any future interference claims could arise, and if successful, result in the issuance of a
patent that could limit our freedom to operate in respect to Zohydro ER®, which could also cause a reduction in revenue for our CDMO
segment and have a material adverse effect on our business, prospects, results of operations and financial condition.
It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection.
The patent positions of pharmaceutical companies can be highly uncertain and involve complex legal and factual questions for which
important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has
emerged in the United States to date. The pharmaceutical patent situation outside of the United States is even more uncertain. Changes in
either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual
property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in the patents that may be issued from the
applications we currently or may in the future own or license from third parties. Further, if any patent license we obtain is deemed invalid
and/or unenforceable, it could impact our ability to commercialize or partner our technology.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:
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we were the first to make the inventions covered by each of our pending patent applications;
we were the first to file patent applications for these inventions;
others will not independently develop similar or alternative technologies or duplicate any of our technologies;
an individual or party will not challenge inventorship, that if successful, could have an adverse effect on our business;
any patents issued to us or our collaborators will provide a basis for commercially viable products, will provide us with
any competitive advantages or will not be challenged by third parties; or
the patents of others will not have an adverse effect on our business.
If we do not adequately protect our proprietary rights, competitors may be able to use our technologies and erode or negate any
competitive advantage we may possess, which could materially harm our business, negatively affect our position in the marketplace, limit
our ability to commercialize our product candidates and delay or render impossible our achievement of profitability.
We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
In the future, we may rely on trade secrets to protect our proprietary know-how and technological advances, especially where we
do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on
confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to
protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential
information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition,
others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary
to enforce and determine the scope of our proprietary rights. Failure to obtain or maintain trade secret protection could enable competitors
to use our proprietary information to develop products that compete with our products or cause additional, material adverse effects on our
competitive business position.
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Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications
will be due to be paid to the United States Patent and Trademark Office and various foreign governmental patent agencies in
several stages over the lifetime of the patents and/or applications.
We have systems in place to remind us to pay periodic maintenance fees, renewal fees, annuity fees and various other patent and
application fees, and we employ an outside law firm to pay these fees. The U.S. Patent and Trademark Office and various foreign
governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
during the patent application process. We employ an outside law firm and other professionals to help us comply, and in many cases, an
inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are
situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete
loss of patent rights in the relevant jurisdiction. If this occurs, our competitors may be able to enter the market, which would have a
material adverse effect on our business.
We may not be able to enforce our intellectual property rights throughout the world.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United
States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign
jurisdictions. The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other
intellectual property protection, especially those relating to life sciences. This could make it difficult for us to stop the infringement of our
patents or the misappropriation of our other intellectual property rights. For example, many foreign countries have compulsory licensing
laws under which a patent owner must grant licenses to third parties. In addition, many countries limit the enforceability of patents against
third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention
from other aspects of our business. Accordingly, our efforts to protect our intellectual property rights in such countries may be
inadequate. In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to
obtain adequate protection for our technology and the enforcement of intellectual property. If we are unable to adequately enforce our
intellectual property rights throughout the world, our business, financial condition, and results of operations could be adversely impacted.
Our ability to manufacture products for our commercial partners may be impaired if any of our manufacturing activities,
or the activities of third parties involved in our manufacture and supply chain, are found to infringe patents of others.
Our ability to continue to manufacture Ritalin LA®, Focalin XR®, Verelan PM®, Verelan SR®, Verapamil PM, Verapamil SR
and Zohydro ER® for our commercial partners, to utilize third parties to supply raw materials or other products, or to perform fill/finish
services or other steps in our manufacture and supply chain, depends on our and their ability to operate without infringing the patents and
other intellectual property rights of others. Other parties may allege that our manufacturing activities, or the activities of third parties
involved in our manufacturing and supply chain, infringe patents or other intellectual property rights. A judicial decision in favor of one or
more parties making such allegations could preclude the manufacture of the products to which those intellectual property rights apply,
which could materially harm our business, operating results and financial condition.
Risks Relating to Our Securities
The market price and trading volume of our common stock have been and may continue to be volatile, which could result
in rapid and substantial losses for our shareholders.
The market price for our common stock has been volatile and may continue to fluctuate or may decline significantly in the
future. An active, liquid and orderly market for our common stock may not be sustained, which could depress the trading price of our
common stock or cause it to continue to be highly volatile or subject to wide fluctuations. Some of the factors that could negatively affect
our share price or result in fluctuations in the price or trading volume of our common stock include, among other things:
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our ability to resolve the deficiencies identified by the FDA in the CRL for IV meloxicam and obtain regulatory
approval of IV meloxicam;
the approved labeling for IV meloxicam, if any;
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our ability to successfully commercialize IV meloxicam, if approved;
FDA, state or international regulatory actions, including actions on regulatory applications for any of our product
candidates;
legislative or regulatory changes;
judicial pronouncements interpreting laws and regulations;
changes in government programs;
announcements of new products, services or technologies, commercial relationships, acquisitions or other events by us
or our competitors;
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fluctuations in stock market prices and trading volumes of similar companies;
changes in accounting principles;
litigation or public concern about the safety of our product candidates or similar product candidates;
sales of large blocks of our common stock, including sales by our executive officers, directors and significant
shareholders
our announcement of financing transactions, including debt, convertible notes, etc.;
actions by institutional or activist shareholders; and
our discontinuance, licensing or sale of any asset or segment of our business.
These broad market and industry factors may decrease the market price of our common stock, regardless of our actual operating
performance. For example, on May 24, 2018, we announced the receipt from the FDA of a CRL for our NDA for IV meloxicam. The
announcement was followed by a substantial decrease in the trading price of our common stock on the Nasdaq Capital Market. In addition,
in the past, following periods of volatility in the overall market and decreases in the market price of a company’s securities, securities class
action litigation has often been instituted against these companies. Following the decrease in our trading price in May 2018, a securities
class action lawsuit was filed against us and certain of our officers and directors for alleged violations of Section 10(b) and 20(a) of the
Exchange Act and Rule 10(b)(5) promulgated thereunder. The complaint seeks unspecified damages, interest, attorneys’ fees and other
costs. On December 10, 2018, lead plaintiff filed an amended complaint that asserted the same claims and sought the same relief but
included new allegations and named additional officers and directors as defendants. On February 8, 2019, we filed a motion to dismiss the
amended complaint in its entirety. While we believe that the lawsuit is without merit and intend to vigorously defend against it, the lawsuit
is in the early stages and, at this time, no assessment can be made as to its likely outcome or whether the outcome will be material to
us. This litigation, and any other securities class actions that may be brought against us, could result in substantial costs and a diversion of
our management’s attention and resources.
The JOBS Act allows us to postpone the date by which we must comply with certain laws and regulations and reduce the
amount of information provided in reports filed with the SEC. We cannot be certain if the reduced disclosure requirements
applicable to emerging growth companies will make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act. We will remain an emerging growth company until the
earliest of (1) December 31, 2019, (2) the beginning of the first fiscal year after our annual gross revenue is $1.07 billion or more, (3) the
date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt securities and (4) as of
the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million as of the end of the
second quarter of that fiscal year.
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For as long as we remain an “emerging growth company,” we may take advantage of certain exemptions from various reporting
requirements that are applicable to public companies that are not “emerging growth companies” inc luding, but not limited to, not being
required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations
regarding executive compensation and financial statements in our periodic reports and proxy statements, and exemptions from the
requirements of holding a nonbinding advisory vote to approve executive compensation and shareholder approval of any golden parachute
payments not previously approved. In addition, Section 102(b)(1) of the JOBS Act also provides that an emerging growth company can
take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, or the Securities
Act, for complying with new or revised accounting standards. An emerging growth company can therefore delay the adoption of certain
accounting standards until those standards would otherwise apply to private companies. However, we have chosen to “opt out” of such
extended transition period and, as a result, we will comply with new or revised accounting standards on the relevant dates on which
adoption of such standards is required for non-emerging growth companies. Section 102(b)(1) of the JOBS Act provides that our decision
to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable.
We cannot predict if investors will find our common stock less attractive because we may rely on some of these exemptions. If
some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our
stock price may be more volatile. Our reduced disclosure may make it more difficult for investors and securities analysts to evaluate us
and may result in less investor confidence, which could have a material adverse effect on the trading price of our common stock.
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur,
could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity
securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.
Certain holders of our securities are entitled to rights with respect to the registration of their shares under the Securities
Act. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the
Securities Act. Any sales of shares by these shareholders could have a material adverse effect on the trading price of our common stock.
If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial
statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of
us.
Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce
accurate financial statements on a timely basis is a costly and time-consuming effort that will need to be frequently evaluated. Section 404
of the Sarbanes-Oxley Act requires public companies to conduct an annual review and evaluation of their internal controls and attestations
of the effectiveness of internal controls by independent auditors (the latter requirement does not apply to smaller reporting companies-we
qualify as a smaller reporting company). Our failure to maintain the effectiveness of our internal controls in accordance with the
requirements of the Sarbanes-Oxley Act could have a material adverse effect on our business. We could lose investor confidence in the
accuracy and completeness of our financial reports, which could have an adverse effect on the price of our common stock.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in
reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized and
reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or
internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the
objectives of the control system are met.
These inherent limitations include the realities that judgments in decision‑making can be faulty, and that breakdowns can occur
because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two
or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system,
misstatements or insufficient disclosures due to error or fraud may occur and not be detected.
64
If securities or industry analysts do not continue to publish research or reports, or if they publish unfavorable research or
reports, about our business, our stock price and trading volume could decline.
The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish
about us, our business, our market or our competitors. We currently have limited research coverage by securities and industry analysts. If
additional securities or industry analysts do not commence coverage of our company, the trading price for our stock could be negatively
impacted. In the event we obtain securities or industry analyst coverage, if one or more of the analysts who covers us downgrades our
stock, our stock price would likely decline. If one or more of these analysts ceases to cover us or fails to regularly publish reports on us,
interest in our stock could decrease, which could cause our stock price or trading volume to decline.
We have never paid dividends on our common stock and do not intend to do so for the foreseeable future.
We have never paid dividends on our common stock and we do not anticipate that we will pay any dividends on our common
stock for the foreseeable future. Accordingly, any return on an investment in our common stock will be realized, if at all, only when
shareholders sell their shares. In addition, our failure to pay dividends may make our stock less attractive to investors, adversely impacting
trading volume and price.
The concentration of our capital stock ownership with our directors and their affiliated entities and our executive officers
will limit shareholders’ abilities to influence certain corporate matters.
Our directors and their affiliated entities, and our executive officers, beneficially own, in the aggregate, approximately 14% of our
outstanding common stock as of December 31, 2018. As a result, these shareholders are collectively able to influence matters requiring
approval of our shareholders, including the election of directors and approval of significant corporate transactions, such as mergers,
consolidations or the sale of all or substantially all of our assets. Such influence may delay, prevent or deter a change in control of our
company, even when such a change may be in the best interests of some shareholders, impede a merger, consolidation, takeover or other
business combination involving us, or could deprive our shareholders of an opportunity to receive a premium for their common stock as
part of a sale of our company or our assets and might adversely affect the prevailing market price of our common stock.
Some provisions of our charter documents and Pennsylvania law may have anti‑takeover effects that could discourage an
acquisition of us by others, even if an acquisition would be beneficial to our shareholders, and may prevent attempts by our
shareholders to replace or remove our current management.
Provisions in our articles of incorporation and amended and restated bylaws could make it more difficult for a third-party to
acquire us or increase the cost of acquiring us, even if doing so would benefit our shareholders, or remove our current management. These
include provisions that:
•
•
•
•
•
divide our board of directors into three classes with staggered three-year terms;
provide that a special meeting of shareholders may be called only by a majority of our board of directors;
establish advance notice procedures with respect to shareholder proposals to be brought before a shareholder meeting
and the nomination of candidates for election as directors, other than nominations made by or at the direction of the
board of directors or a committee of the board of director;
provide that shareholders may only act at a duly organized meeting; and
provide that members of our board of directors may be removed from office by our shareholders only for cause by the
affirmative vote of 75% of the total voting power of all shares entitled to vote generally in the election of directors.
65
These provisions may frustrate or prevent any attempts by our shareholders to replace or remove our current management by
making it more difficult for shareholders to replace members of our board of directors, who are responsible for appointing the members of
our management. Because we are incorporated in Pennsylvania, we are governed by the provisions of the Pennsylvania Business
Corporation Law of 1988, which may discourage, delay or prevent someone from acquiring us or merging with us whether or not it is
desired by or beneficial to our shareholders. Under Pennsylvania law, a corporation may not, in general, engage in a business combination
with any holder of 20% or more of its capital stock unless the holder has held the stock for five years or, among other things, the board of
directors has approved the transaction. Any provision of our articles of incorporation or bylaws or Pennsylvania law that has the effect of
delaying or deterring a change in control could limit the opportunity for our shareholders to receive a premium for their shares of our
common stock, and could also affect the price that some investors are willing to pay for our common stock.
Item 1B.
Unresolved Staff Comments
None.
Item 2.
Properties
Our principal executive offices, primarily used by our Acute Care Segment are located at 490 Lapp Road, Malvern, PA 19355,
where we occupy approximately 22,313 square feet of leased laboratory and office space pursuant to a six-year lease, which expires on
December 31, 2022. The Acute Care Segment also leases a 4,145 square foot office space in Dublin, Ireland, which expires April 16, 2020.
Our CDMO segment currently operates our owned 97,000 square foot, DEA-licensed facility in Gainesville, Georgia and leased 24,000
square foot development and high potency product services facility, also in Gainesville, GA, which expires on June 30, 2025.
Item 3.
Legal Proceedings
On May 31, 2018, a securities class action lawsuit was filed against us and certain of our officers and directors in the U.S. District
Court for the Eastern District of Pennsylvania (Case No. 2:18-cv-02279-MMB) that purported to state a claim for alleged violations of
Section 10(b) and 20(a) of the Exchange Act and Rule 10(b)(5) promulgated thereunder, based on statements made by us concerning the
NDA for IV meloxicam. The complaint seeks unspecified damages, interest, attorneys’ fees and other costs. On December 10, 2018, lead
plaintiff filed an amended complaint that asserted the same claims and sought the same relief but included new allegations and named
additional officers and directors as defendants. On February 8, 2019, we filed a motion to dismiss the amended complaint in its entirety. We
believe that the lawsuit is without merit and intend to vigorously defend against it. The lawsuit is in the early stages and, at this time, no
assessment can be made as to its likely outcome or whether the outcome will be material to us.
Item 4.
Mine Safety Disclosures
Not applicable.
66
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock is traded on the NASDAQ Capital Market under the symbol “REPH.”
Holders of Common Stock
As of February 15, 2019, there were 9 holders of record of our common stock. We believe that the number of beneficial owners of
our common stock at that date was substantially greater.
Dividend Policy
We have never declared or paid any cash dividends on our common stock and our ability to pay cash dividends is currently
prohibited by the terms of our credit facility with Athyrium. We do not anticipate paying cash dividends on our common stock in the
foreseeable future. Payment of future dividends, if any, on our common stock will be at the discretion of our board of directors after taking
into account various factors, including our financial condition, operating results, anticipated cash needs and plans for expansion.
Issuer Repurchases of Equity Securities
None.
Securities Authorized for Issuance Under Equity Compensation Plans
Other information about our equity compensation plans is incorporated herein by reference to Part III, Item 12 of this Annual Report
on Form 10-K.
Recent Sales of Unregistered Securities
None.
67
Performance Graph
This performance graph shall not be deemed “soliciting material” or to be “filed” with the SEC for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities under that Section, and shall not
be deemed to be incorporated by reference into any of our filings under the Securities Act or the Exchange Act.
The following graph illustrates a comparison of the total cumulative stockholder return for our common stock since March 7,
2014, which is the first trading day for our stock, to two indices: the NASDAQ Composite Index and the NASDAQ Biotechnology Index.
The graph assumes an initial investment of $100 on March 7, 2014, in our common stock, the stocks comprising the NASDAQ Composite
Index, and the stocks comprising the NASDAQ Biotechnology Index. Historical stockholder return is not necessarily indicative of the
performance to be expected for any future periods.
68
Item 6.
Selected Financial Data
The following tables present our selected financial data for the periods indicated. The consolidated statements of operations data for
the years ended December 31, 2018, 2017 and 2016 and the selected consolidated balance sheet data as of December 31, 2018 and 2017
have been derived from our audited financial statements included elsewhere in this Annual Report on Form 10-K. The consolidated
statements of operations data for the years ended December 31, 2015 and 2014 and the consolidated balance sheet data as of December 31,
2016, 2015 and 2014 have been derived from audited financial statements not included in this Annual Report on Form 10-K. Our historical
results are not necessarily indicative of the results that may be expected in the future. The selected financial data below should be read in
conjunction with the information contained in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,”
the consolidated financial statements and notes thereto, and other financial information included elsewhere in this Annual Report on
Form 10-K.
Year ended December 31,
Consolidated Statements of Operations Data:
Revenue
Operating expenses:
Cost of sales (excluding amortization of intangible
assets)
Research and development
General and administrative
Amortization of intangible assets
Change in warrant valuation
Change in contingent consideration valuation
Total operating expenses
Operating loss
Other income (expense):
Interest income
Interest expense
Loss before income taxes
Income tax benefit
Net income (loss)
Accretion of redeemable convertible preferred stock
and deemed dividend
Net income (loss) applicable to common shareholders
Basic net income (loss) per common share
Diluted net income (loss) per common share
Weighted average basic common shares outstanding
Weighted average diluted common shares
outstanding
Consolidated Balance Sheet Data:
Cash, cash equivalents and short-term investments
Working capital
Total assets
Debt, net
Total liabilities
Total shareholders’ equity (deficit)
2018
2017
2016
(in thousands, except share and per share data)
2015
2014
$
77,347 $
71,834 $
69,337 $
51,952 $
—
43,160
39,985
36,879
2,583
284
8,499
131,390
(54,043 )
512
(8,756 )
(62,287 )
(17,436 )
(79,723 )
38,193
33,095
25,426
2,583
9
12,839
112,145
(40,311 )
385
(12,034 )
(51,960 )
1,880
(50,080 )
37,152
33,278
12,742
2,583
(373 )
9,728
95,110
(25,773 )
49
(5,588 )
(31,312 )
1,107
(30,205 )
28,054
12,281
13,017
1,884
(1,560 )
5,246
58,922
(6,970 )
12
(5,560 )
(12,518 )
15,551
3,033
—
7,874
3,998
—
—
—
11,872
(11,872 )
11
(4,273 )
(16,134 )
—
(16,134 )
—
(79,723 ) $
—
(50,080 ) $
—
(30,205 ) $
—
3,033 $
(1,270 )
(17,404 )
$
$
(3.90 ) $
(2.63 ) $
(2.82 ) $
(2.79 )
(3.90 ) $
$
(2.79 )
20,465,106 19,070,983 10,721,928 8,491,025 6,238,581
(2.63 ) $
(2.82 ) $
0.36 $
0.21 $
20,465,106 19,070,983 10,721,928 8,749,234 6,238,581
2018
2017
As of December 31,
2016
(in thousands)
2015
2014
$
38,514 $
42,112
155,493
64,243
174,993
(19,500 )
64,482 $
37,379
186,226
53,598
157,378
28,848
64,483 $
68,497
182,997
24,388
111,384
71,613
19,779 $
29,189
138,697
29,760
98,347
40,350
19,682
18,928
20,374
—
1,446
18,928
69
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated
financial statements and the related notes appearing elsewhere. In addition to historical information, this discussion and analysis contains
forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed
below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed
in the section titled “Risk Factors” included in Part I, Item 1A of this Annual Report on Form 10-K.
Overview
We are a specialty pharmaceutical company that operates through two business segments: an Acute Care segment and a revenue-
generating CDMO segment. Each of these segments are deemed to be reportable segments for financial reporting purposes.
Our Acute Care segment is primarily focused on developing and commercializing innovative products for hospital and other acute
care settings. Our lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV
meloxicam has successfully completed three Phase III clinical trials for the management of moderate to severe pain, consisting of two
pivotal efficacy trials and a large double-blind Phase III safety trial, as well as other safety studies. Overall, the total new drug application,
or NDA, program included over 1,400 patients. In July 2017, we submitted an NDA to the U.S. Food and Drug Administration, or FDA, for
IV meloxicam for the management of moderate to severe pain. In May 2018, we received a Complete Response Letter, or CRL, from the
FDA regarding our NDA for IV meloxicam. In July 2018, we participated in a Type A End-of-Review meeting with the FDA to discuss the
topics covered in the CRL. In September 2018 we resubmitted the NDA for IV meloxicam and the FDA has set a date for decision on the
NDA under the Prescription Drug User Fee Act, or PDUFA, of March 24, 2019. Our Acute Care segment has no revenue and our costs
consist primarily of expenses incurred in conducting our manufacturing scale-up, clinical trials and preclinical studies, regulatory activities,
pre-commercialization of meloxicam and personnel costs.
Our CDMO segment leverages formulation expertise to develop and manufacture pharmaceutical products using proprietary delivery
technologies for commercial partners who commercialize or plan to commercialize these products. These collaborations result in revenue
streams including manufacturing, royalties or profit sharing, and research and development, which support continued operations for our
CDMO segment and have contributed excess cash flow to be used for activities in our Acute Care segment. We operate a 97,000 square
foot, DEA-licensed manufacturing facility in Gainesville, Georgia and we currently develop and/or manufacture the following key products
with our commercial partners: Ritalin LA®, Focalin XR®, Verelan PM®, Verelan SR®, Verapamil PM, Verapamil SR and Zohydro ER®,
as well as supporting development stage products. In October 2018, we opened a 24,000 square foot GMP development and high potency
product services facility, also in Gainesville, GA. Our CDMO segment’s revenue streams are primarily derived from manufacturing, and
royalty revenues, as well as research and development services performed for commercial partners.
We have incurred losses and generated negative cash flows from operations since inception and expect to continue to incur
significant and increasing operating losses for the foreseeable future. Substantially all of our operating losses resulted from costs incurred
in connection with our development programs, including our non-clinical and formulation development activities, manufacturing, clinical
trials and pre-commercialization activities. We have used cash flow generated by our CDMO segment primarily to fund operations at our
Gainesville, Georgia manufacturing facilities, to make payments under our credit facility and to partially fund our development and pre-
commercialization activities of our Acute Care segment. We believe our CDMO segment will continue to contribute cash for general
corporate purposes that may reduce the amount of external capital needed to fund development and commercial operations. Our expenses
over the next several years are expected to relate to obtaining regulatory approval for IV meloxicam, successfully commercializing IV
meloxicam, if approved, and continuing to develop our other current and future product candidates.
On April 10, 2015, we completed the acquisition from Alkermes of certain assets, including the worldwide rights to injectable
meloxicam and the development, formulation and manufacturing business that comprised our CDMO segment, which we refer to as the
Gainesville Transaction. The consideration paid consisted of $50.0 million cash, a $4.0 million working capital adjustment and a seven-
year warrant to purchase 350,000 shares of our common stock at an exercise price of $19.46 per share. In addition, according to the
agreement, as amended, we were required to pay up to an additional $140.0 million in milestone payments, including regulatory and net
sales milestones, and a royalty percentage of future product net sales related to IV meloxicam. In December 2018, we entered into an
Amendment to the Purchase and Sale Agreement with Alkermes which restructured the $45 million milestone originally due upon FDA
approval of IV meloxicam to (i) a $5 million payment made within 30 days of the amendment; (ii) a $5 million payment due by April 23,
2019; (iii) a $5 million payment due within 180 days following approval of an NDA for IV meloxicam; and (iv) an additional $45 million
following approval of an NDA for injectable meloxicam, payable over a seven year period. In addition, we amended our warrant held by
Alkermes to decrease the exercise price to $8.26 per share.
70
Financial Overview
Revenues
During the twelve months ended December 31, 2018, 2017 and 2016, we recognized revenues from three revenue streams:
manufacturing revenue, royalty revenue and research and development revenue. All revenue is generated from our CDMO segment.
Manufacturing revenue
We recognize manufacturing revenue from the sale of products we manufacture for our commercial partners. Manufacturing
revenues are recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that
reflects the consideration we expect to be entitled to as specified in the agreement with the commercial partner, which could include pricing
and volume-based adjustments.
Royalty revenue
We recognize royalty or profit sharing revenue, collectively referred to as royalty revenue, related to the sale of products by our
commercial partners that incorporate our technologies. Royalty revenues are generally recognized under the terms of the applicable
license, development and/or supply agreement. For arrangements that include sales-based royalties and the license is deemed to be the
predominant item to which the royalties relate, we recognize revenue when the related sales occur by the commercial partner. For
arrangements that include sales-based royalties and the license is not deemed to be the predominant item to which the royalties relate, we
recognize revenue when the performance obligation to which the royalty has been allocated has been satisfied, which is upon transfer of
control of a product to a customer. In this case, significant judgment is used in the estimation of these royalties based on historical
customer pricing and deductions and is partially constrained due to items that are outside of our control including the uncertainty of the
timing of future commercial partner sales, mix of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments
made by our commercial partners.
Research and development revenue
Research and development revenue consists of revenue that compensates us for services performed at our CDMO, such as
formulation, process development, and preparation of pre-clinical and clinical drug product materials prepared by our CDMO segment
under research and development arrangements with partners. Revenues related to research and development are generally recognized as the
related services or activities are performed using the output method and in accordance with the contract terms. To the extent that the
agreements specify services are to be performed on a fixed basis, revenues are recognized consistent with the pattern of the work
performed. In agreements which specify milestones, we evaluate whether the milestones are considered probable of being achieved and
estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue
reversal would not occur, the value of the associated milestone is recognized at a point in time. Non-refundable milestone payments
related to arrangements under which we have continuing performance obligations would be deferred and recognized over the period of
performance. Milestone payments that are not within our control, such as submission for approval to regulators by a partner or approvals
from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are
received.
Research and Development Expenses
Research and development expenses currently consist primarily of costs incurred by our Acute Care segment in connection with the
development of injectable meloxicam and other pipeline activities. These expenses consist primarily of:
•
•
•
•
•
•
expenses incurred under agreements with contract services organizations, investigative sites and consultants that conduct our
clinical trials and a substantial portion of our preclinical studies;
the cost of acquiring and manufacturing clinical trial drug supply and related manufacturing services and pre-commercial
product validation and inventory manufacturing expenses;
costs related to facilities, depreciation and other allocated expenses;
acquired in-process research and development;
costs associated with non-clinical and regulatory activities; and
salaries and related costs for personnel in research and development and regulatory functions.
The majority of our external research and development costs relate to clinical trials, manufacturing of drug supply for pre-
commercial products, analysis and testing of product candidates and patent costs. Costs related to facilities, depreciation and support are not
charged to specific programs.
71
The successful development of IV meloxicam and our other product candidates is highly uncert ain and subject to a number of risks,
including, but not limited to:
•
•
•
•
•
•
•
the costs, timing and outcome of regulatory review of a product candidate, including, with respect to IV meloxicam, the
nature and scope of any activities required to resolve the CRL issued by the FDA in response to our NDA for IV meloxicam,
which may include the completion of additional studies;
the duration of clinical trials, which varies substantially according to the type, complexity and novelty of the product
candidate;
substantial requirements on the introduction of pharmaceutical products imposed by the FDA and comparable agencies in
foreign countries, which require lengthy and detailed laboratory and clinical testing procedures, sampling activities and other
costly and time-consuming procedures;
the possibility that data obtained from pre-clinical and clinical activities at any step in the testing process may be adverse and
lead to discontinuation or redirection of development activity or may be susceptible to varying interpretations, which could
delay, limit or prevent regulatory approval;
risk involved with development of manufacturing processes, FDA pre-approval inspection practices and successful
completion of manufacturing batches for clinical development and other regulatory purposes;
the emergence of competing technologies and products and other adverse market developments, which could impede our
commercial efforts; and
the other risks disclosed in the section titled “Risk Factors” of this Annual Report on Form 10-K for the fiscal year ended
December 31, 2018.
Development timelines, probability of success and development costs vary widely. As a result of the uncertainties discussed above,
we anticipate that we will make determinations as to which additional programs to pursue and how much funding to direct to each program
on an ongoing basis in response to the scientific and clinical data of each product candidate, additional information as we progress through
our discussions with the FDA around the CRL regarding our NDA for IV meloxicam, as well as ongoing assessments of such product
candidate’s commercial potential and available capital resources. Accordingly, we cannot currently estimate with any degree of certainty
the amount of time or costs that we will be required to expend in the future on our product candidates to complete current or future clinical
or pre-commercial stages prior to their regulatory approval, if such approval is ever granted. As a result of these uncertainties surrounding
the timing and outcome of any approvals, we are currently unable to estimate precisely when, if ever, any of our product candidates will
generate revenues and cash flows.
We expect our research and development costs to relate to IV meloxicam as we seek to obtain regulatory approval for IV meloxicam,
and if successful in obtaining regulatory approval, advance IV meloxicam through the commercialization scale-up, clinical and other
activities. We also expect to have expenses as we initiate clinical trials and related work for our other product candidates. We may elect to
seek collaborative relationships in order to provide us with a diversified revenue stream and to help facilitate the development and
commercialization of our product candidate pipeline. We expect our research and development costs to continue to increase as we continue
clinical and pre-commercialization manufacturing activities for IV meloxicam and engage in pipeline development activities.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related costs for personnel in executive, pre-commercial and
finance and information technology functions. General and administrative expenses also include professional fees for legal, including
patent-related expenses, consulting, auditing and tax services and CDMO business development activities.
Our general and administrative expenses were lower for the second half of 2018 as we progressed through our discussions with the
FDA regarding the CRL as compared to the first half of 2018 when we were preparing for a potential commercial launch of IV meloxicam.
We expect these expenses to increase in 2019 depending on the timing of the regulatory approval process and subsequent
commercialization of IV meloxicam. In addition, we will continue to incur costs relating to our operations as a public company, including
salary, consulting, legal, patent and compliance, accounting, insurance and investor relations costs.
72
Amortization of Intangible Assets
We recognize amortization expense related to the intangible asset for our contract manufacturing relationships on a straight-line basis
over an estimated useful life of six years. The intangible asset related to injectable meloxicam represents in process research and
development, or IPR&D, which is considered an indefinite-lived intangible asset that is assessed for impairment annually or more
frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-
off, and we will record a noncash impairment loss on our Consolidated Statements of Operations and Comprehensive Loss. For those
compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives.
Change in Fair Value of Contingent Consideration
Pursuant to the Purchase and Sale Agreement for the Gainesville Transaction, as amended in December 2018, we are required to pay
up to an additional $140.0 million in milestone payments, including $10.0 million during the first half of 2019, another $5.0 million due
within 180 days of approval of IV meloxicam and $45.0 million over seven years beginning one year after approval, as well as net sales
milestones and a royalty percentage of future product net sales related to IV meloxicam between 10% and 12% (subject to a 30% reduction
when no longer covered by patent). The estimated fair value of the initial $54.6 million payment obligation was recorded as part of the
purchase price for the Gainesville Transaction. We have continued to reevaluate the fair value each subsequent period and as of
December 31, 2018 had recorded a $90.9 payment obligation, representing the estimated probability adjusted fair value. We expect, at a
minimum, contingent consideration will further increase by approximately $25 million to $30 million as we approach the PDUFA date for
the IV meloxicam NDA and potential approval of IV meloxicam. Each reporting period, we revalue this estimated obligation with changes
in fair value recognized as a non-cash operating expense or gain.
Change in Fair Value of Warrants
We have classified as liabilities certain warrants outstanding that contain a contingent net cash settlement feature, upon a change in
control. The fair value of these warrants are remeasured through settlement or expiration with changes in fair value recognized as a period
charge within the Consolidated Statements of Operations and Comprehensive Loss.
Interest Expense, net
Interest expense, net for the twelve months ended December 31, 2018 was a result of interest expense incurred on our Athyrium
senior secured term loan and the amortization of the related financing costs. Interest expense for the twelve months ended December 31,
2017 was a result of interest expense incurred on our OrbiMed and Athyrium senior secured term loans and the amortization of the related
financing costs. In addition, due to the November 2017 refinancing of our debt, in 2017 we incurred one-time charges for fees related to
early extinguishment of the OrbiMed debt and the non-cash write-off of OrbiMed deferred financing costs. Interest expense, net for the
twelve months ended December 31, 2016 was a result of interest expense incurred on our OrbiMed senior secured term loan and the
amortization of the related financing costs.
Net Operating Losses and Tax Carryforwards
As of December 31, 2018, we had approximately $21.3 million of federal net operating loss carryforwards. We also had federal and
state research and development tax credit carryforwards of $4.3 million available to offset future taxable income. U.S. tax laws limit the
time during which these carryforwards may be utilized against future taxes. With the exception of the 2018 federal net operating loss which
has an indefinite carry forward period, these federal and state net operating loss and federal and state tax credit carryforwards will begin to
expire at various dates beginning in 2028, if not utilized. We have also generated foreign net operating loss carryforwards in Ireland. We
currently do not believe it is more likely than not we will use any of these federal, state or foreign net operating losses and as a result have
recorded a full valuation allowance against the deferred tax asset related to the losses.
Under the Tax Reform Act of 1986, or the Act, the utilization of a corporation’s net operating loss and research and development tax
credit carryforwards is limited following a greater than 50% change in ownership during a three-year period. Any unused annual limitation
may be carried forward to future years for the balance of the carryforward period. We determined that we have experienced ownership
changes, as defined by the Act, during the 2008, 2014 and 2016 tax years as a result of past financings; accordingly, our ability to utilize
the aforementioned carryforwards will be limited. In addition, state net operating loss carryforwards may be further limited, including in
Pennsylvania, which has a limitation of 30%, 35% or 40% of taxable income after modifications and apportionment on state net operating
losses utilized in any one year during tax years beginning during 2017, 2018 or 2019 going forward respectively. In addition, since we will
need to raise substantial additional funding to finance our operations, we may undergo further ownership changes in the future, including
changes to our organizational structure relating to foreign operations, purchases, sales and licenses, which could further limit our ability to
use net operating loss carryforwards. As a result, if we generate taxable income, our ability to use some of our net operating loss
carryforwards to offset U.S. federal and state taxable income may be subject to limitations, which could result in increased future tax
liabilities to us.
73
As discussed in Note 19 to the Consolidated Financial Statements included in this Form 10-K, in December 2017, the federal
government enacted numerous amendments to the Internal Revenue Code of 1986 pursuant to the Tax Act. The Tax Act has and will
impact our income tax expense/(benefit) from operations in the current and in future periods. The Tax Act resulted in the following impacts
to us:
•
•
Our federal statutory income tax rate was reduced from 34% to 21% for 2018 and tax years following.
Our results for the fourth quarter of 2017 included a one-time net expense of $7.9 million, as a result of remeasuring our
deferred tax balances to the new statutory rate.
• We will be able to claim an immediate deduction for investments in qualified fixed assets acquired and placed in service
beginning September 27, 2017 through 2022. This provision phases out through 2026.
•
Given our taxable losses in the U.S., we will be limited in our ability to deduct interest expense, and any disallowed interest
expense for 2018 and tax years following will result in an indefinite carry forward until such time as we meet the taxable
income thresholds required to deduct interest expense.
Results of Operations
Comparison of the Twelve Months Ended December 31, 2018 and 2017
Revenue
Operating expenses:
Cost of sales (excluding amortization of intangible assets)
Research and development
General and administrative
Amortization of intangible assets
Change in warrant valuation
Change in contingent consideration valuation
Total operating expenses
Operating loss
Other income (expense):
Interest expense, net
Loss before income taxes
Income tax (expense)/benefit
Net loss
Year ended December 31,
2018
(amounts in thousands)
2017
$
77,347 $
71,834
43,160
39,985
36,879
2,583
284
8,499
131,390
(54,043 )
(8,244 )
(62,287 )
(17,436 )
(79,723 ) $
38,193
33,095
25,426
2,583
9
12,839
112,145
(40,311 )
(11,649 )
(51,960 )
1,880
(50,080 )
$
Revenue and costs of sales. Our revenues were $77.3 million and $71.8 million and cost of sales were $43.2 million and
$38.2 million for the twelve months ended December 31, 2018 and 2017, respectively. The increase of $5.5 million in revenue includes the
impact from the new standard Accounting Standards Update, or ASU, No. 2014-09, “ Revenue from Contracts with Customers,” or ASU
2014-09, and was primarily due to increased profit sharing royalties recognized from one of our commercial partners and an increase in
product sales to various commercial partners. The increase in cost of sales of $5.0 million was primarily due to product mix and expanded
service and development capabilities as well as growth in manufacturing demand.
Research and Development. Our research and development expenses were $40.0 million and $33.1 million for the twelve months
ended December 31, 2018 and 2017, respectively. The increase of $6.9 million in 2018 was primarily due to an increase in pre-
commercialization manufacturing costs for IV meloxicam, an increase in development costs for other pipeline products, an increase in
Phase IIIb clinical trial costs, and an increase in salaries and benefits expense. These increases were partially offset by a decrease in Phase
III clinical trial costs and NDA costs due to the prior year NDA filing fee.
General and Administrative. Our general and administrative expenses were $36.9 million and $25.4 million for the twelve months
ended December 31, 2018 and 2017, respectively. The increase of $11.5 million was primarily due to commercial team personnel and pre-
commercial consulting costs in the first half of the year in preparation of the anticipated launch of IV meloxicam, public company costs
including legal fees, business development costs in our CDMO segment as well as increased professional fees associated with addressing
the CRL issued by the FDA regarding our NDA for IV meloxicam.
74
Amortization of Intangible Assets. Amortization expense was $2.6 million for the twelve months ended December 31, 2018 and
2017, which was exclusively related to the amortization of our royalties and contract manufacturing relationships intangible asset over its
estimated useful life.
Interest Expense, net. Interest expense, net was $8.2 million and $11.6 million during the twelve months ended December 31, 2018
and 2017, respectively. The decrease in interest expense, net, was due to the refinancing of our prior credit agreement with OrbiMed in
2017, which resulted in a one-time charge of approximately $6.8 million for fees related to early extinguishment of debt and the non-cash
write-off of related deferred financing costs. Excluding the one-time charges in 2017 for the debt refinancing, interest expense, net,
increased year over year due to the higher principal balance on our Athyrium senior secured term loan and amortization of the related
financing costs.
Income Tax (Expense)/Benefit. Income tax (expense)/benefit was ($17.4) million and $1.9 million for the twelve months ended
December 31, 2018 and 2017, respectively. The increase in income tax expense was primarily due to the recognition of a full valuation
allowance against our federal and state net deferred tax assets and the increase to the valuation allowance against our foreign net deferred
tax assets. As a result of the Tax Cuts and Jobs Act of 2017, included within income tax benefit for the year ended December 31, 2017 was
a non-cash adjustment of $7.9 million for the remeasurement of the net deferred tax items using the recently enacted 21% statutory tax
rate. As discussed in Note 19 to the Consolidated Financial Statements included in this Form 10-K, we believe that it is more likely than not
that the deferred income tax assets associated with our U.S. and foreign operations will not be realized, and as such, there is a full valuation
allowance against our U.S. and foreign deferred tax assets.
Operating Income (Loss) per Segment.
CDMO Segment-
Our CDMO segment’s revenues were $77.3 million and $71.8 million and cost of sales were $43.2 million and $38.2 million for the
twelve months ended December 31, 2018 and 2017, respectively. The increase of $5.5 million in revenue was primarily due to increased
profit sharing royalties recognized from one of our commercial partners including the impact from the new accounting standard ASU 2014-
09 and an increase in product sales to various commercial partners.
Our CDMO segment’s operating expenses (including cost of sales) increased by $6.0 million, from $46.4 million in the twelve
months ended December 31, 2017 to $52.4 million in the twelve months ended December 31, 2018. Costs of sales were $43.2 million and
$38.2 million, for the twelve months ended December 31, 2018 and 2017, respectively. The increase in cost of sales of $5.0 was primarily
due to product mix and expanded service and development capabilities attributed to the anticipated rise in manufacturing and research and
development services demand. Research and development expenses decreased by $0.1 million and general and administrative expenses
increased by $1.1 million. All of the above contributed to our CDMO segment’s operating income of $24.9 million for the twelve months
ended December 31, 2018, which included non-cash charges of $7.5 million for depreciation and amortization and $1.3 million for stock-
based compensation.
Acute Care Segment-
Our Acute Care segment’s operating expenses (excluding non-cash charges for contingent consideration and warrants) increased
$17.3 million from $52.9 million in the twelve months ended December 31, 2017 to $70.2 million in the twelve months ended
December 31, 2018. Research and development expenses increased $7.0 million as a result of increased IV meloxicam pre-
commercialization manufacturing costs, salaries and benefits and Phase IIIb clinical trial costs. The increase was partially offset by a
decrease in Phase III clinical trial costs and NDA costs due to the prior year NDA filing fee. General and administrative costs increased by
$10.4 million as a result of increased salaries and benefits and increased pre-commercialization consulting expenses as well as costs due to
the CRL including severance and increased professional fees associated with delay in potential commercial launch of IV meloxicam and
addressing the CRL issued by the FDA regarding our NDA for IV meloxicam. The non-cash charge for contingent consideration decreased
by $4.3 million due to the change in estimated timing of approval of IV meloxicam and the amendment of the development milestones due
to Alkermes. All of the above, as well as the non-cash charges for warrants and contingent consideration, contributed to our Acute Care
segment’s operating loss of $79.0 million for the twelve months ended December 31, 2018, which also included non-cash charges of $6.3
million for stock-based compensation, depreciation and amortization.
75
Comparison of the Years Ended December 31, 2017 and 2016
Revenue
Operating expenses:
Cost of sales (excluding amortization of intangible assets)
Research and development
General and administrative
Amortization of intangible assets
Change in warrant valuation
Change in contingent consideration valuation
Total operating expenses
Operating loss
Other income (expense):
Interest expense, net
Loss before income taxes
Income tax benefit
Net loss
Year ended December 31,
2017
(amounts in thousands)
2016
$
71,834 $
69,337
38,193
33,095
25,426
2,583
9
12,839
112,145
(40,311 )
(11,649 )
(51,960 )
1,880
(50,080 ) $
37,152
33,278
12,742
2,583
(373 )
9,728
95,110
(25,773 )
(5,539 )
(31,312 )
1,107
(30,205 )
$
Revenue and costs of sales. Our revenues were $71.8 million and $69.3 million and cost of sales were $38.2 million and
$37.2 million for the twelve months ended December 31, 2017 and 2016, respectively. Excluding the $2.3 million, one-time, contractually
based manufacturing revenue amount from one of our commercial partners in the twelve months ended December 31, 2016, the $4.8
million increase in 2017 revenue versus 2016 was primarily due to higher profit share royalties as a result of stronger sales volumes and
pricing of one of our products as well as increased manufacturing revenue. These increases were partially offset by decreased royalty
revenue due to a change in the mix of generic and brand sales by another of our commercial partners. Costs of sales were $38.2 million and
$37.2 million for the twelve months ended December 31, 2017 and 2016, respectively. The increase in cost of sales of $1.0 million was
primarily due to changes in the product mix.
Research and Development. Our research and development expenses were $33.1 million and $33.3 million for the twelve months
ended December 31, 2017 and 2016, respectively. The decrease of $0.2 million in 2017 was primarily due to lower IV meloxicam clinical
trial expenses offset by increases in pre-commercialization IV meloxicam product validation, manufacturing and support costs, NDA filing
fees and development costs for our other pipeline products.
General and Administrative. Our general and administrative expenses were $25.4 million and $12.7 million for the twelve months
ended December 31, 2017 and 2016, respectively. The increase of $12.7 million was primarily due to building of the commercial team and
its related infrastructure, and pre-commercial activities for IV meloxicam.
Amortization of Intangible Assets. Amortization expense was $2.6 million for the twelve months ended December 31, 2017 and
2016 which was exclusively related to the amortization of our royalties and contract manufacturing relationships intangible asset over its
estimated useful life.
Interest Expense, net. Interest expense, net was $11.6 million and $5.5 million during the twelve months ended December 31, 2017
and 2016, respectively. The increase in interest expense, net, was due to the refinancing of our prior credit agreement with OrbiMed in 2017
which resulted in a one-time charge totaling approximately $6.8 million for fees related to early extinguishment of debt and the non-cash
write-off of related deferred financing costs. Additionally, the higher principal balance on our Athyrium senior secured term loan and
amortization of the related financing costs contributed to an increase in interest expense, net.
Income Tax Benefit. Income tax benefit was $1.9 million and $1.1 million for the twelve months ended December 31, 2017 and
2016, respectively. The increase in income tax benefit was primarily due to the increase in net loss before income. As a result of the Tax
Cuts and Jobs Act of 2017, included within income tax benefit for the year ended December 31, 2017 was a non-cash adjustment of $7.9
million for the remeasurement of the net deferred tax items using the recently enacted 21% statutory tax rate. We believe that it is more
likely than not that the deferred income tax assets associated with our foreign operations will not be realized, and as such, there is a full
valuation allowance against our foreign deferred tax assets.
76
Operating Income (Loss) per Segment.
CDMO Segment-
Our CDMO segment’s revenues were $71.8 million and $69.3 million and cost of sales were $38.2 million and $37.2 million for the
twelve months ended December 31, 2017 and 2016, respectively. Excluding the $2.3 million, one-time, contractually based manufacturing
revenue amount from one of our commercial partners in the twelve months ended December 31, 2016, the $4.8 million increase in revenue
versus prior year was primarily due to increased profit share royalties as a result of increased sales volumes and pricing by one of our
commercial partners as well as increased manufacturing revenue. These increases were partially offset by decreased royalty revenue due to
a change in the mix of generic and brand sales by one of our commercial partners.
Our CDMO segment’s operating expenses (including cost of sales) increased by $1.3 million, from $45.1 million in the twelve
months ended December 31, 2016 to $46.4 million in the twelve months ended December 31, 2017. Costs of sales were $38.2 million and
$37.2 million, for the twelve months ended December 31, 2017 and 2016, respectively. The increase in cost of sales of $1.0 million was
primarily due to changes in the product mix. Research and development expenses decreased by $0.3 million due to expanded investment in
our formulation and development capabilities and general and administrative expenses increased by $0.6 million. All of the above
contributed to our CDMO segment’s operating income of $25.4 million for the twelve months ended December 31, 2017, which included
non-cash charges of $7.4 million for depreciation and amortization and $1.0 million for stock-based compensation.
Acute Care Segment-
Our Acute Care segment’s operating expenses (excluding non-cash charges for contingent consideration and warrants) increased
$12.2 million from $40.7 million in the twelve months ended December 31, 2016 to $52.9 million in the twelve months ended
December 31, 2017. Research and development expenses increased $0.1 million as a result of increased IV meloxicam pre-
commercialization manufacturing costs, NDA filing fees and increased headcount, which was partially offset by a decrease in our IV
meloxicam clinical trial expenses. General and administrative costs increased by $12.1 million as a result of increased headcount and
increased pre-commercialization marketing expenses. The non-cash charge for contingent consideration increased by $3.1 million. All of
the above, as well as the non-cash charges for warrants and contingent consideration, contributed to our Acute Care segment’s operating
loss of $65.7 million for the twelve months ended December 31, 2017, which also included non-cash charges of $4.6 million for stock-
based compensation, depreciation and amortization.
Liquidity and Capital Resources
As of December 31, 2018, we had $38.5 million in cash and cash equivalents and short-term investments.
Since inception through December 31, 2018, we have financed our product development, operations and capital expenditures
primarily from sales of equity and debt securities, including sales of our common stock with net proceeds of $133.5 million, and term loans
made under our previous and existing credit facilities, including our credit facility with Athyrium with an outstanding balance of $70.0
million and contributions of excess cash flow from our CDMO segment. During the twelve months ended December 31, 2018, our capital
expenditures were $10.5 million, which increased primarily related to expansion of the CDMO capabilities to support anticipated new
business activities.
We will need to raise substantial additional funds in order to fund the payments which may become due, including milestone
payments owed to Alkermes or other licensing partners, to commercialize IV meloxicam, if approved, to continue our Phase IIIb program
for IV meloxicam, to commence our clinical trial programs of our other product candidates, to commercialize any of our other product
candidates or technologies that receive regulatory approval and to enhance our sales and marketing efforts for additional products we may
acquire. Insufficient funds may cause us to delay, reduce the scope of or eliminate one or more of our development, commercialization or
expansion activities. Our future capital needs and the adequacy of our available funds will depend on many factors, including our ability to
timely and adequately resolve the CRL issued by the FDA regarding our NDA for IV meloxicam, the cost of studies and other actions that
may be needed to obtain regulatory approval for IV meloxicam, the timing of approval of IV meloxicam, the level of market acceptance of
IV meloxicam and the costs of commercialization activities for IV meloxicam, if approved, the continued profitability of our CDMO
segment, and our ability to access additional tranches under our Credit Agreement with Athyrium. We may raise such additional funds
through debt refinancing, bank or other loans, through strategic research and development, licensing, including out-licensing activities, sale
of assets and/or marketing arrangements or through public or private sales of equity or debt securities from time to time. Financing may not
be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely impact our growth plans
and our financial condition or results of operations. Additional debt or equity financing, if available, may be dilutive to the holders of our
common stock and may involve significant cash payment obligations and covenants that restrict our ability to operate our business or access
to capital.
77
On March 7, 2015, in connection with the Gainesville Transaction, we, through a wholly owned subsidiary, entered into a credit
agreement with OrbiMed. Pursuant to the credit agreement, OrbiMed provided us with a term loan in the original principal amount of
$50.0 million on April 10, 2015, which amount was used to fund the Gainesville Transaction. On November 17, 2017, we entered into our
credit agreement with Athyrium, pursuant to which we drew upon an initial $60.0 million term loan. We used the proceeds from the initial
term loan to (i) repay in full all outstanding indebtedness under our credit facility with OrbiMed of approximately $31.7 million, which
included the remaining debt principal balance of $27.3 million and early termination charges of $4.4 million and (ii) pay transaction fees
associated with the credit facility with Athyrium of approximately $4.2 million. In December 2018 we amended the credit agreement with
Athyrium and drew upon a $10 million term B-1 loan. We have the ability to draw upon two additional tranches of term loans, each in the
aggregate original principal amount of $15 million, subject to certain timing and milestone restrictions, including that we receive regulatory
approval of IV meloxicam by September 30, 2019. As of December 31, 2018, we had $70 million outstanding principal under our credit
agreement with Athyrium.
Sources and Uses of Cash
Cash used in operations was $43.1 million, $17.0 million and $3.2 million for the twelve months ended December 31, 2018, 2017
and 2016, respectively, which represents our operating losses less our stock-based compensation, depreciation, non-cash interest expense,
loss on early extinguishment of debt, acquired IPR&D, changes in fair value of warrants and contingent consideration and amortization of
intangibles, as well as changes in operating assets and liabilities.
Cash used in investing activities was $7.1 million, $10.3 million and $3.8 million for the twelve months ended December 31, 2018
and 2017 and 2016, respectively, and reflected cash used for the purchase of short-term investments offset by maturities/redemption of
investments and for the purchase of property and equipment. Our short-term investments were classified as available for sales securities
with maturities of less than one year.
There was $27.7 million of cash provided by financing activities in the twelve months ended December 31, 2018 from proceeds from
issuance of long-term debt from Athyrium of $10.0 million, net proceeds of $17.0 million from the sale of shares of common stock through
our Common Stock Purchase Agreement with Aspire Capital and proceeds of $1.8 million from exercise of options, which was partially
offset by deferred financing costs of $1.0 million from the Athyrium transaction and $0.1 million of payments of withholdings on shares
withheld for income taxes. Cash provided by financing activities was $23.9 million for the twelve months ended December 31, 2017, from
proceeds from issuance of long-term debt from Athyrium of $60.0 million, offset by repayment of long term debt for the payoff of the
OrbiMed debt of $27.3 million, fees related to early extinguishment of debt paid to OrbiMed of $4.4 million and deferred financing costs
from the Athyrium transaction of $4.2 million. Cash provided by financing activities was $51.7 million for the twelve months ended
December 31, 2016, primarily as a result of the sale of common stock raising net proceeds of $58.1 million, partially offset by payments of
$6.3 million on long-term debt.
Our future use of operating cash and capital requirements will depend on many forward-looking factors, including the following:
•
•
•
•
•
•
•
•
•
•
•
our ability to resolve the deficiencies identified by the FDA in the complete response letter, or CRL, for intravenous, or IV,
meloxicam;
whether the FDA will approve our amended NDA for IV meloxicam and, if approved, the labeling under any such approval
that we may obtain;
if the FDA does not approve our amended NDA, the time frame otherwise associated with resolving the deficiencies
identified by the FDA in the CRL and whether the FDA will require additional clinical studies to support the approval of IV
meloxicam and the time and cost of such studies;
the timing and outcome of our Phase IIIb clinical trials for IV meloxicam;
the timing of the Gainesville Transaction regulatory milestone payments and other contingent consideration;
the costs of manufacturing scale-up and commercialization activities, for IV meloxicam, if approved;
the level of market acceptance of IV meloxicam, if approved;
the scope, progress, results and costs of development for our other product candidates;
the cost, timing and outcome of regulatory review of our other product candidates;
the cost of manufacturing scale-up, acquiring drug product and other capital equipment for our other product candidates;
the extent to which we in-license, acquire or invest in products, businesses and technologies;
78
•
•
•
•
•
•
•
•
•
the timing and extent of our manufacturing and capital expenditures related to our CDMO segment;
our ability to maintain our relationships and contracts with our commercial partners;
our ability to continue profitability in our CDMO segment;
our ability to comply with stringent U.S. & foreign government regulation in the manufacture of pharmaceutical products,
including cGMP and U.S. DEA requirements;
the extent to which we choose to establish collaboration, co-promotion, distribution or other similar agreements for product
candidates;
our ability to access additional tranches of term loans under our credit agreement with Athyrium;
our ability to raise additional funds through equity or debt financings or sale of certain assets;
the costs of preparing, submitting and prosecuting patent applications and maintaining, enforcing and defending intellectual
property claims; and
the effect of any changes in our effective tax rate due to changes in the mix of earnings in countries with differing statutory
tax rates, changes in the valuation of deferred tax assets and liabilities and changes in tax laws.
We might use existing cash and cash equivalents on hand, additional debt, equity financing, sale of assets or out-licensing revenue or a
combination thereof to fund our operations or product acquisitions. If we increase our debt levels, we might be restricted in our ability to
raise additional capital and might be subject to financial and restrictive covenants. Our shareholders may experience dilution as a result of
the issuance of additional equity or debt securities. This dilution may be significant depending upon the amount of equity or debt securities
that we issue and the prices at which we issue any securities.
Contractual Commitments
The table below reflects our contractual commitments as of December 31, 2018:
Contractual Obligations
Long-Term Debt Obligations (1):
Athyrium Debt
Interest on Debt
Purchase Obligations (2):
Operating Leases (3)
Other Long-Term Liabilities:
Other License Commitments and Milestone payments (4), (5)
Alkermes Payments (6)
Employment Agreements (7)
Other Non-Current Liabilities (8)
Total Contractual Obligations
Payments Due by Period (in 000s)
Less than
1 year
1-3 years 3-5 years
More than
5 years
Total
$
$
$
$
$
$
$
$
$
70,700 $
34,589
26,763
2,849
— $
8,916
21,374
781
— $
17,856
2,335
1,136
70,700 $
7,817
28
685
54,010
140,000
461
62
25
—
461
—
100
—
—
34
150
—
—
19
—
—
—
247
315
—
—
9
329,434 $
31,557 $
21,461 $
79,399 $
571
(1) The long-term debt obligations consist of principal, an exit fee of 1% of the principal, and interest on the outstanding balance
of $70.0 million of our $100 million credit facility with Athyrium as of December 31, 2018. The debt bears interest at a rate of
LIBOR plus 9.75% per annum. Due to fluctuations of the future LIBOR interest rate, it has been set at the rate as of
December 31, 2018 to calculate the obligation. In accordance with U.S. GAAP, the future interest obligations are not recorded
on our Consolidated Balance Sheet. See Note 12 to the Consolidated Financial Statements included in this Form 10-K.
79
(2) These obligations consist of cancelable and non-cancelable purchase commitments related to inventory, capital expenditures
and other goods or services. In accordance with U.S. GAAP, these obligations are not recorded on our Consolidated Balance
Sheets. See Note 13 to the Consolidated Financial Statements included in this Form 10-K.
(3) We have become party to certain operating leases, for the leased space in Malvern, Pennsylvania, Gainesville, Georgia and
Dublin, Ireland, as well as for residential and office equipment, for which the minimum lease payments are presented. See
Note 13(d) to the Consolidated Financial Statements included in this Form 10-K.
(4) We are party to exclusive licenses with Orion for the development and commercialization of certain pipeline product
candidates, under which we may be required to make certain milestone and royalty payments to Orion. See Note 5 and Note
13(a) to the Consolidated Financial Statements included in the Form 10-K. The amount reflects only payment obligations that
are fixed and determinable. We are unable to reliably estimate the timing of these payments because they are dependent on
the type and complexity of the clinical studies and intended uses of the products, which have not been established. In
accordance with U.S. GAAP, these obligations are not recorded on our Consolidated Balance Sheets.
(5) We license the NMBAs from Cornell University pursuant to a license agreement under which we are obligated to make annual
license maintenance fee payments, milestone payments and patent cost payments and to pay royalties on net sales of the
NMBAs. The amount reflects only payment obligations that are fixed and determinable. We are unable to reliably estimate
the timing of certain of these payments because they are dependent on the type and complexity of the clinical studies and
intended uses of the products, which have not been established. In accordance with U.S. GAAP, certain of these obligations
are not recorded on our Consolidated Balance Sheets. See Note 5 and 13(a) to the Consolidated Financial Statements included
in this Form 10-K.
(6) Pursuant to the purchase and sale agreement governing the Gainesville Transaction, we agreed to pay to Alkermes milestone
and royalty payments. The amount reflects only payment obligations that are fixed and determinable. We are unable to
reliably estimate the timing of these payments because they are in some instances, events that are not in our control and
dependent on the commercial success of the product. In accordance with U.S. GAAP, the fair value of these obligations are
recorded as contingent consideration on our Consolidated Balance Sheets. See Note 4 and Note 13(b) to the Consolidated
Financial Statements included in this Form 10-K.
(7) We have entered into employment agreements with certain of our named executive officers. As of December 31, 2018, these
employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than this
amount, from that date through calendar year 2019. In accordance with U.S. GAAP, these obligations are not recorded on our
Consolidated Balance Sheets. See Note 13 (f) to the Consolidated Financial Statements included in this Form 10-K.
(8) This value represents the deferred rent. In accordance with U.S. GAAP, these liabilities are recorded on our Consolidated
Balance Sheets. See Note 13(a) to the Consolidated Financial Statements included in this Form 10-K.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.
Critical Accounting Policies and Estimates
This management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial
statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets
and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those
related to accrued expenses, revenue recognition, stock-based compensation and contingent consideration. We base our estimates on
historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different assumptions or conditions.
80
Impairment of Goodwill and Indefinite-lived Intangible Assets – We are required to review, on an annual basis, the carrying value of
goodwill and indefinite-lived intangible assets, to determine whether impairment may exist. For goodwill, the impairment model prescribes
a one-step method for determining impairment. The one-step quantitative test calculates the amount of goodwill impairment as the excess
of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The
impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset to its carrying
value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. Based on accounting
standards, it is required that these assets be assessed at least annually for impairment unless a triggering event occurs between annual
assessments which would then require an assessment in the period which a triggering event occurred.
Impairment of Long-lived Assets—We are required to review the carrying value of long-lived fixed and amortizing intangible assets
for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of an asset or asset group may not
be recoverable. The impairment test is a two-step test. Under step one we assess the recoverability of an asset (or asset group). The carrying
amount of an asset (or asset group) is not recoverable if it exceeds the sum of the undiscounted cash flows expected from the use and
eventual disposition of the asset (or asset group). The impairment loss is measured in step two as the difference between the carrying value
of the asset (or asset group) and its fair value. Assumptions and estimates used in the evaluation of impairment are subjective and changes
in these assumptions may negatively impact projected undiscounted cash flows, which could result in impairment charges in future periods.
On an ongoing periodic basis, we evaluate the useful life of our long-lived assets and determine if any economic, governmental or
regulatory event has modified their estimated useful lives.
Contingent Consideration — We revalue our contingent consideration on a quarterly basis using a discounted cash flow valuation
model. The model uses significant unobservable inputs, including the probability and timing of FDA approval and successful product
launch. We estimate IV meloxicam net revenues based on estimated market share, pricing and customary trade discounts, taking into
consideration variables such as, market acceptance of the product and the expected number of product competitors in the market.
Revenue Recognition— We generate revenues from manufacturing, packaging, research and development, and related services for
multiple pharmaceutical companies through our CDMO segment. Our agreements with our commercial partners provide for manufacturing
revenues, sales-based royalties and/or profit sharing components. Our revenue policies listed below are reflective of ASU 2014-09, which
we adopted effective January 1, 2018. See Note 18 to the Consolidated Financial Statements included in this Form 10-K for additional
information regarding our adoption of ASU 2014-09 and its impact on our financial statements.
Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon
shipment, based on a transaction price that reflects the consideration we expect to be entitled to as specified in the agreement with the
commercial partner.
In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based
royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the commercial
partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. For
arrangements that include sales-based royalties where the license for intellectual property is deemed to be the predominant item to which
the royalties relate, we recognize revenue when the related sales occur by the commercial partner. For arrangements that include sales-
based royalties where the license for intellectual property is not deemed to be the predominant item to which the royalties relate, we
recognize revenue upon transfer of control of the manufactured product. In these cases, significant judgment is required to calculate this
estimated variable consideration using the most-likely amount method based on historical customer pricing and deductions and is partially
constrained due to items that are outside of our control including the uncertainty of the timing of future commercial partner sales, mix of
volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by our commercial partners.
Revenues related to research and development are generally recognized over-time as the related services or activities are performed
using the output method and in accordance with the contract terms. In agreements which specify milestones, we evaluate whether the
milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely
amount method. Milestone payments related to arrangements under which we have continuing performance obligations would be deferred
and recognized over the period of performance. Milestone payments that are not within our control, such as submission for approval to
regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are
submitted by the customer or approvals are received.
81
Income taxes - We use the asset and liability method of accounting for income taxes. Under this method, defe rred tax assets and
liabilities are determined based on differences between the financial statement carrying amount and the tax basis of assets and liabilities
and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. We provide a
valuation allowance when it is more-likely-than-not that deferred tax assets will not be realized.
On a periodic basis, we evaluate the realizability of our deferred tax assets and adjust such amounts in light of changing facts and
circumstances, including but not limited to projections of future taxable income, the reversal of deferred tax liabilities, tax legislation,
rulings by relevant tax authorities, tax planning strategies and the progress of ongoing tax examinations. As part of this evaluation, we
consider whether it is more likely than not that all or some portion of the deferred tax asset will not be realized. The ultimate realization of
a deferred tax asset is dependent upon the generation of future taxable income during the period in which the related temporary difference
becomes deductible or the net operating loss, or NOL, and credit carryforwards can be utilized.
We maintain a full valuation allowance against our deferred tax assets where realizability is not certain. We periodically evaluate the
likelihood of the realization of deferred tax assets and adjust the carrying amount of these deferred tax assets by a valuation allowance
based on the anticipated realizability. The valuation allowance can be reversed if objective negative evidence in the form of cumulative
losses is no longer present and additional weight is given to subjective evidence, such as our projection of future growth. This
determination depends on a variety of factors, some of which are subjective, including our current year taxable income in the United States,
expectations of future taxable income, impact of tax reform, achievement of milestones, carryforward periods available to us for tax
reporting purposes, various income tax strategies and other relevant factors. If we determine that the deferred tax assets realizability is
impacted, we would record material changes to income tax expense in that period.
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
We are exposed to market risks in the ordinary course of our business. These market risks are principally limited to interest rate
fluctuations. At December 31, 2018, we had approximately $29.7 million invested in money market instruments and government and
agency bonds. We believe our policy of investing in highly-rated securities, whose liquidities are, at December 31, 2018, all less than two
months, minimizes such risks. Due to the short-term duration of our investment portfolio and the low-risk profile of our investments, an
immediate 10.0% change in interest rates would not have a material effect on the fair market value of our portfolio. Accordingly, we would
not expect our operating results or cash flows to be affected to any significant degree by the effect of a sudden change in market interest
rates on our investment portfolio. We do not enter into investments for trading or speculative purposes. Our Athyrium secured term loan
interest expense is based on the current committed rate of three-month LIBOR plus 9.75% with a 1.0% LIBOR floor. A fluctuation in
LIBOR of 0.25% would result in a charge of $0.2 million of interest expense over a twelve-month period.
We have license agreements with Orion for certain product pipeline candidates which require the payment of milestones upon the
achievement of certain regulatory and commercialization events and royalties on product sales, which are required to be made in Euros. As
of December 31, 2018, no milestones or royalties were due under these agreements, and we do not anticipate incurring milestone or royalty
costs under these agreements until we advance our development of certain product pipeline candidates. We do not believe foreign currency
exchange rate risk is a material risk at this time; however, these agreements could, in the future, give rise to foreign currency transaction
gains or losses. As a result, our results of operations and financial position could be exposed to changing currency exchange rates. In the
future, we may periodically use forward contracts to hedge certain transactions or to neutralize exposures.
Item 8.
Financial Statements and Supplementary Data
Our consolidated financial statements and the report of our independent registered public accounting firm are included in this Annual
Report on Form 10-K on the pages indicated in Part IV, Item 15.
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosures
None.
82
Item 9A.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness
of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of
1934, as amended, or the Exchange Act) as of December 31, 2018. We maintain disclosure controls and procedures that are designed to
provide reasonable assurance that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is
accumulated and communicated to our management, including our principal executive officer and principal financial officer, as
appropriate, to allow for timely decisions regarding required disclosure.
A control system, no matter how well conceived and operated, can provide only reasonable, and not absolute, assurance that the
objectives of the control system will be met. Further, the design of a control system must reflect the fact that there are resource constraints,
and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been
detected. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be
detected. However, our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2018, our principal executive officer and principal
financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control
over financial reporting is a process designed to provide reasonable assurance of the reliability of financial reporting and of the preparation
of financial statements for external reporting purposes, in accordance with U.S. generally accepted accounting principles.
Internal control over financial reporting includes policies and procedures that (1) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect transactions and disposition of assets; (2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in accordance with U.S. generally accepted accounting principles, and
that receipts and expenditures are being made only in accordance with the authorization of its management and directors; and (3) provide
reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could
have a material effect on its financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of the effectiveness to future periods are subject to the risk that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies and procedures included in such controls may deteriorate.
Our management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2018. In making
this assessment, management used the criteria established by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO) in Internal Control – Integrated Framework (2013). These criteria are in the areas of control environment, risk assessment, control
activities, information and communication, and monitoring. Management’s assessment included extensive documentation, evaluating and
testing the design and operating effectiveness of its internal controls over financial reporting.
Based on the Management’s processes and assessment, as described above, management has concluded that, as of December 31,
2018, our internal control over financial reporting was effective.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f)
under the Exchange Act) during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
83
Item 9B.
Other Information
On February 19, 2019, we entered into the Purchase Agreement with Aspire Capital, pursuant to which we have the right to sell to
Aspire Capital from time to time in our sole discretion up to $20.0 million in shares of our common stock over the next 30 months, subject
to certain limitations and conditions set forth in the Purchase Agreement. In consideration for entering into the Purchase Agreement, we
have agreed to issue to Aspire Capital 34,762 shares of our common stock, or the Commitment Shares, on February 19, 2019.
Concurrently with entering into the Purchase Agreement, we also entered into a registration rights agreement, or the Registration
Rights Agreement, with Aspire Capital, pursuant to which we agreed to file with the SEC a prospectus supplement to our effective shelf
registration statement on Form S-3 (File No. 333-218487), registering all of the shares of common stock that may be offered to Aspire
Capital from time to time, including the Commitment Shares.
Under the Purchase Agreement, on any trading day we select, following the filing of the prospectus supplement and the satisfaction
of other closing conditions, we have the right, in our sole discretion, to present Aspire Capital with a purchase notice, or a Purchase Notice,
directing Aspire Capital (as principal) to purchase up to 75,000 shares of common stock per trading day, up to an aggregate of $20.0
million of common stock, at a per share price, or the Purchase Price, equal to the lesser of:
•
•
the lowest sale price of the common stock on the purchase date; or
the arithmetic average of the three lowest closing sale prices for our common stock during the 10 consecutive trading days
ending on the trading day immediately preceding the purchase date.
The aggregate purchase price payable by Aspire Capital on any one purchase date may not exceed $500,000, unless otherwise
mutually agreed, and upon mutual agreement we may issue up to 2,000,000 shares of common stock under a purchase notice.
In addition, on any date on which we submit a purchase notice to Aspire Capital, we also have the right, in our sole discretion, to
present Aspire Capital with a volume-weighted average price purchase notice, or a VWAP Purchase Notice, directing Aspire Capital to
purchase an amount of common stock equal to up to 30% of the aggregate shares of common stock traded on our principal market on the
next trading day, or the VWAP Purchase Date, as we determine. The purchase price per share pursuant to such VWAP Purchase Notice is
generally 97% of the volume-weighted average price for the common stock traded on our principal market on the VWAP Purchase Date.
We may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the
Purchase Agreement, so long as the most recent purchase has been completed.
The Purchase Agreement provides that we and Aspire Capital will not affect any sales under the Purchase Agreement on any
purchase date where the closing sale price of our common stock is less than $0.50. There are no trading volume requirements or restrictions
under the Purchase Agreement, and we will control the timing and amount of sales of common stock to Aspire Capital.
The Purchase Agreement provides that the number of shares that may be sold pursuant to the Purchase Agreement will be limited to
4,372,373 shares, including the Commitment Shares, or the Exchange Cap, which represents 19.99% of our outstanding shares of common
stock as of February 19, 2019, unless stockholder approval or an exception pursuant to the rules of the NASDAQ Capital Market is
obtained to issue more than 19.99%. This limitation will not apply if, at any time the Exchange Cap is reached and at all times thereafter,
the average price paid for all shares issued under the Purchase Agreement is equal to or greater than $8.63, which was the average of the
five closing sale prices of our common stock immediately preceding the execution of the Purchase Agreement. We are not required or
permitted to issue any shares of common stock under the Purchase Agreement if such issuance would breach our obligations under the rules
or regulations of the NASDAQ Capital Market.
The Purchase Agreement may be terminated by us at any time, at our discretion, without any cost to us. Aspire Capital has agreed
that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of our
common stock during any time prior to the termination of the Purchase Agreement. Aspire Capital has no right to require any sales by us,
but is obligated to make purchases from us as directed by us in accordance with the Purchase Agreement. There are no limitations on use of
proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated
damages in the Purchase Agreement.
Any proceeds we receive under the Purchase Agreement are expected to be used for commercial activities for IV meloxicam,
pipeline development activities, the payment of Alkermes milestones, and general corporate purposes.
The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are
qualified in their entirety by reference to the full text of the Purchase Agreement and the Registration Rights Agreement, which are
attached hereto as Exhibits 10.34 and 4.8, respectively, and incorporated by reference herein.
Pepper Hamilton LLP, counsel to the Company, has issued an opinion to the Company, dated February 19, 2019, regarding the
validity of the shares of common stock to be issued and sold pursuant to the Purchase Agreement. A copy of the opinion is filed as Exhibit
5.1 to this Annual Report on Form 10-K.
84
Item 10.
Directors, Executive Officers and Corporate Governance
PART III
Information with respect to this item will be set forth in the Proxy Statement for the 2018 Annual Meeting of Shareholders, or the
Proxy Statement, under the headings “Board of Directors,” “Executive Officers,” “Section 16(a) Beneficial Ownership Reporting
Compliance,” and “Corporate Governance and Risk Management” and is incorporated herein by reference. The Proxy Statement will be
filed with the SEC within 120 days after the end of the fiscal year covered by this Annual Report.
Our board of directors has adopted a Code of Business Conduct and Ethics, or Code of Conduct, applicable to all of our employees,
executive officers and directors. The Code of Conduct is available on our website at www.recropharma.com. Our board of directors is
responsible for overseeing compliance with the Code of Conduct, and our board of directors or an appropriate committee thereof must
approve any waivers of the Code of Conduct for employees, executive officers or directors. Disclosure regarding any amendments to the
Code of Conduct, or any waivers of its requirements, will be made on our website.
Item 11.
Executive Compensation
Information with respect to this item will be set forth in the Proxy Statement under the headings “Director Compensation,”
“Executive Compensation,” and “Corporate Governance and Risk Management” is incorporated herein by reference. The Proxy Statement
will be filed with the SEC within 120 days after the end of the fiscal year covered by this Annual Report.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Equity Compensation Plan Information
Number of
securities to
be issued
upon exercise
of
outstanding
options and
other rights
Weighted-
average
exercise
price of
outstanding
options and
other rights(1)
Number of securities
remaining available
for future issuance
under equity
compensation plans
(excluding securities
reflected in column
(a))
4,095,461 (2) $
7.46
3,777,352
783,000 (3) $
$
4,878,461
8.24
7.62
— (4)
3,777,352
Plan Category
Equity compensation plans approved by security
Holders
Equity compensation plans not approved by
security
Holders
Total
(1)
(2)
(3)
Represents the weighted-average exercise price of outstanding stock options and does not include restricted stock units.
Consists of outstanding (i) options to purchase 3,026,315 shares of common stock and (ii) restricted stock units covering an
aggregate of 1,069,146 shares of common stock. Shares in settlement of vested restricted stock units are deliverable within 30
days of the vesting date.
Reflects grants of stock options and restricted stock units that were “inducement grants” as defined under NASDAQ Listing
Rule 5635(c)(4). The terms and conditions of each inducement grant are subject to the terms and conditions of the Form of
Award Agreement for Option Inducement Awards Form of Award Agreement for Restricted Stock Unit Inducement Awards,
included as Exhibits 10.13 and 10.14, respectively, of this Annual Report on Form 10-K.
(4) Our board of directors has not established any specific number of shares that could be issued without shareholder approval.
Inducement grants to new key employees are determined on a case-by-case basis. Other than possible inducement grants, we
expect that all equity awards will be made under shareholder-approved plans.
Other information with respect to this item will be set forth in the Proxy Statement under the headings “Security Ownership of
Directors, Certain Beneficial Owners and Management,” “Executive Compensation,” and “Director Compensation,” and is incorporated
herein by reference. The Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year covered by this Annual
Report.
85
Item 13.
Certain Relationships and Related Transactions, and Director Independence
Information with respect to this item will be set forth in the Proxy Statement under the headings “Certain Relationships and Related
Party Transactions” and “Corporate Governance and Risk Management” and is incorporated herein by reference. The Proxy Statement will
be filed with the SEC within 120 days after the end of the fiscal year covered by this Annual Report.
Item 14.
Principal Accounting Fees and Services
Information with respect to this item will be set forth in the Proxy Statement under the heading “Independent Registered Public
Accounting Firm,” and is incorporated herein by reference. The Proxy Statement will be filed with the SEC within 120 days after the end
of the fiscal year covered by this Annual Report.
86
Item 15.
Exhibits, Consolidated Financial Statement Schedules
(a)(1) Consolidated Financial Statements.
PART IV
The following consolidated financial statements are filed as a part of this Annual Report on Form 10-K:
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of December 31, 2018 and 2017
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2018, 2017 and 2016
Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2018, 2017 and 2016
Consolidated Statements of Cash Flows for the years ended December 31, 2018, 2017 and 2016
(a)(2) Consolidated Financial Statement Schedules.
Not applicable.
(a)(3); (b) Exhibits:
Exhibit
No.
2.1†
2.2
2.3
Description
Method of Filing
Purchase and Sale Agreement, dated March 7, 2015, by and among
Recro Pharma, Inc., Recro Pharma LLC, Daravita Limited,
Alkermes Pharma Ireland Limited and Eagle Holdings USA, Inc.
Incorporated herein by reference to Exhibit 2.1 to the
Company’s Current Report on Form 8-K filed on
March 11, 2015 (File No. 001-36329).
First Amendment, dated December 8, 2016 to Purchase and Sale
Agreement, dated March 7, 2015, by and among Recro Pharma, Inc.,
Recro Pharma LLC, Daravita Limited, Alkermes Pharma Ireland
Limited and Eagle Holdings USA, Inc.
Second Amendment, dated December 20, 2018 to Purchase and Sale
Agreement, dated March 7, 2015, by and among Recro Pharma, Inc.,
Recro Pharma LLC, Daravita Limited, Alkermes Pharma Ireland
Limited and Eagle Holdings USA, Inc.
Incorporated by reference to Exhibit 2.1 to the
Company’s Current Report on Form 8-K filed on
December 8, 2016 (File No. 001-36329).
Incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on
December 28, 2018 (File No. 001-36329).
3.1
Second Amended and Restated Articles of Incorporation of Recro
Pharma, Inc.
3.2
Third Amended and Restated Bylaws of Recro Pharma, Inc.
4.1
Specimen certificate evidencing shares of common stock.
4.2
Form of Alkermes Warrant.
Incorporated herein by reference to Exhibit 3.1 to the
Company’s Current Report on Form 8-K filed on
March 13, 2014 (File No. 001-36329).
Incorporated herein by reference to Exhibit 3.2 to the
Company’s Current Report on Form 8-K filed on
March 13, 2014 (File No. 001-36329).
Incorporated herein by reference to Exhibit 4.1 to the
Company’s Registration Statement on Form S-1/A
filed on December 20, 2013 (File No. 333-191879).
Incorporated herein by reference to Exhibit 4.1 to the
Company’s Current Report on Form 8-K filed on
March 11, 2015 (File No. 001-36329).
4.3
First Amendment, dated December 20, 2018 to Warrant to Purchase
Stock, dated April 10, 2015, by and between Recro Pharma, Inc. and
Alkermes Pharma Ireland Limited.
Incorporated by reference to Exhibit 4.1 to the
Company’s Current Report on Form 8-K filed on
December 28, 2018 (File No. 001-36329)
87
Exhibit
No.
4.4
Form of IPO Warrant.
Description
4.5†
Common Stock Purchase Warrant, dated November 17, 2017, in
favor of Athyrium Opportunities III Acquisition LP
4.6†
Common Stock Purchase Warrant, dated November 17, 2017, in
favor of Athyrium Opportunities II Acquisition LP
4.7
Registration Rights Agreement, dated March 2, 2018, by and
between Recro Pharma, Inc. and Aspire Capital Fund, LLC.
Method of Filing
Incorporated herein by reference to Exhibit A of
Exhibit 1.1 to the Company’s Registration Statement
on Form S-1/A filed on February 11, 2014 (File No.
333-191879).
Incorporated herein by reference to Exhibit 4.1 to
the Company’s Current Report on Form 8-K filed on
November 20, 2017 (File No. 001-36329).
Incorporated herein by reference to Exhibit 4.2 to the
Company’s Current Report on Form 8-K filed on
November 20, 2017 (File No. 001-36329).
Incorporated herein by reference to Exhibit 4.8 to the
Company’s Annual Report on Form 10-K filed on
March 2, 2018 (File No. 001-36329).
4.8
5.1
Registration Rights Agreement, dated February 19, 2019, by and
Filed herewith.
between Recro Pharma, Inc. and Aspire Capital Fund, LLC.
Opinion of Pepper Hamilton LLP.
Filed herewith.
10.1†
Dexmedetomidine License Agreement, dated August 22, 2008, by
and among Recro Pharma, Inc. and Orion Corporation.
Incorporated herein by reference to Exhibit 10.1 to the
Company’s Registration Statement on Form S-1/A
filed on November 29, 2013 (File No. 333-191879).
10.2†
First Amendment to Dexmedetomidine License Agreement, dated
January 17, 2009, by and between Recro Pharma, Inc., and Orion
Corporation.
Incorporated herein by reference to Exhibit 10.2 to the
Company’s Registration Statement on Form S-1/A
filed on November 29, 2013 (File No. 333-191879).
10.3†
Dexmedetomidine API Supply Agreement, dated August 22, 2008,
by and among Recro Pharma, Inc., and Orion Corporation.
10.4•
Employment Agreement, dated October 8, 2013, between Recro
Pharma, Inc. and Gerri Henwood.
10.5•
Employment Agreement, dated July 1, 2016, between Recro
Pharma, Inc. and Michael Celano.
10.6•
Employment Agreement, dated June 5, 2017, between Recro
Pharma, Inc. and Ryan D. Lake.
10.7•
Form of Amendment to the Employment Agreement of Gerri
Henwood.
10.8•
Recro Pharma Inc. 2018 Amended and Restated Equity Incentive
Plan.
10.9•
2008 Stock Option Plan.
10.10•
Form of 2008 Stock Option Plan Award Agreement.
Incorporated herein by reference to Exhibit 10.3 to the
Company’s Registration Statement on Form S-1/A
filed on November 29, 2013 (File No. 333-191879).
Incorporated herein by reference to Exhibit 10.5 to the
Company’s Registration Statement on Form S-1/A
filed on November 29, 2013 (File No. 333-191879).
Incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on July
5, 2016 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on June
9, 2017 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.3 to the
Company’s Current Report on Form 8-K filed on
December 19, 2014 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.2 to the
Company’s Quarterly Report on Form 10-Q filed on
May 9, 2018 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.10 to
the Company’s Registration Statement on Form S-1/A
filed on November 29, 2013 (File No. 333-191879).
Incorporated herein by reference to Exhibit 10.11 to
the Company’s Registration Statement on Form S-1/A
filed on November 29, 2013 (File No. 333-191879).
88
Exhibit
No.
10.11•
Form of Equity Incentive Plan Award Agreement.
Description
10.12•
Form of Recro Pharma, Inc. Amended and Restated Equity Incentive
Plan Award Agreement for Restricted Stock Units.
10.13•
Form of Award Agreement for Option Inducement Awards
10.14•
Form of Award Agreement for Restricted Stock Unit Inducement
Awards
Method of Filing
Incorporated herein by reference to Exhibit 10.14 to
the Company’s Annual Report on Form 10-K filed on
March 25, 2015 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K on December
22, 2015 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.1 to the
Company’s Registration Statement on Form S-8 filed
on December 23, 2015 (File No. 333-208750).
Incorporated herein by reference to Exhibit 10.20 to
the Company’s Annual Report on Form 10-K filed on
March 2, 2018 (File No. 001-36329).
10.15†
10.16
10.17
10.18†
10.19†
10.20†
10.21†
10.22†
10.23
10.24
Asset Transfer and License Agreement, dated as of April 10, 2015,
between Alkermes Pharma Ireland Limited and DV Technology
LLC.
Incorporated herein by reference to Exhibit 10.5 to the
Company’s Quarterly Report on Form 10-Q filed on
May 12, 2015 (File No. 001-36329).
Amendment to Asset Transfer and License Agreement, dated
December 23, 2015, between Alkermes Pharma Ireland Limited and
Recro Gainesville LLC
Incorporated herein by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on
December 23, 2015 (File No. 001-36329).
Second Amendment to Asset Transfer and License Agreement, dated
December 20, 2018, between Alkermes Pharma Ireland Limited and
Recro Gainesville LLC
Incorporated herein by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K filed on
December 28, 2018 (File No. 001-36329).
Development, Manufacturing and Supply Agreement, dated July 10,
2015, by and between Alkermes Pharma Ireland Limited and Recro
Pharma, Inc.
Incorporated herein by reference to Exhibit 10.5 to the
Company’s Quarterly Report on Form 10-Q filed on
August 14, 2015 (File No. 001-36329).
First Amendment to the Development, Manufacturing and Supply
Agreement, dated October 19, 2016, by and between Alkermes
Pharma Ireland Limited and Recro Pharma, Inc.
Incorporated herein by reference to Exhibit 10.35 to
the Company’s Annual Report on Form 10-K filed on
March 9, 2017 (File No. 001-36329).
Second Amendment to the Development, Manufacturing and Supply
Agreement, dated February 1, 2017, by and between Alkermes
Pharma Ireland Limited and Recro Pharma, Inc.
Incorporated herein by reference to Exhibit 10.36 to
the Company’s Annual Report on Form 10-K filed on
March 9, 2017 (File No. 001-36329).
Third Amendment to the Development, Manufacturing and Supply
Agreement, dated June 15, 2017, by and between Alkermes Pharma
Ireland Limited and Recro Pharma, Inc.
Incorporated herein by reference to Exhibit 10.1 to the
Company’s Quarterly Report on Form 10-Q filed on
August 11, 2017 (File No. 001-36329).
Amended and Restated License and Supply Agreement, dated
June 26, 2003, by and among Elan Corporation, plc (predecessor-in-
interest to Recro Gainesville LLC) and Watson Laboratories, Inc.
Incorporated herein by reference to Exhibit 10.6 to the
Company’s Quarterly Report on Form 10-Q filed on
August 14, 2015 (File No. 001-36329).
Supplemental Agreement, dated December 8, 2004, to Amended and
Restated License and Supply Agreement, dated June 26, 2003, by
and among Elan Corporation, plc (predecessor-in-interest to Recro
Gainesville LLC) and Watson Laboratories, Inc.
Supplemental Agreement No. 2, dated January 17, 2014, to
Amended and Restated License and Supply Agreement, dated
June 26, 2003, by and among Elan Corporation, plc (predecessor-in-
interest to Recro Gainesville LLC) and Watson Laboratories, Inc.
Incorporated herein by reference to Exhibit 10.7 to the
Company’s Quarterly Report on Form 10-Q filed on
August 14, 2015 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.8 to the
Company’s Quarterly Report on Form 10-Q filed on
August 14, 2015 (File No. 001-36329).
10.25†
License Agreement, dated June 30, 2017, by and between Cornell
University and Recro Pharma, Inc.
Incorporated herein by reference to Exhibit 10.2 to the
Company’s Quarterly Report on Form 10-Q filed on
August 11, 2017 (File No. 001-36329).
89
Exhibit
No.
10.26†
Description
Amendment to License Agreement, dated October 31, 2018, by and
Filed herewith.
Method of Filing
between Cornell University and Recro Pharma, Inc.
10.27†
Master Manufacturing Services Agreement, dated July 14, 2017, by
and between Patheon UK Limited and Recro Ireland Limited
10.28†
Product Agreement, dated July 14, 2017, by and between Patheon
UK Limited and Recro Ireland Limited
Incorporated herein by reference to Exhibit 10.3 to the
Company’s Quarterly Report on Form 10-Q filed on
August 11, 2017 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.4 to the
Company’s Quarterly Report on Form 10-Q filed on
August 11, 2017 (File No. 001-36329).
10.29†
10.30†
Credit Agreement, dated as of November 17, 2017, by and between
Recro Pharma, Inc. and Athyrium Opportunities III Acquisition LP.
*
Incorporated herein by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on
November 20, 2017 (File No. 001-36329).
First Amendment to Credit Agreement and Investment Documents,
dated as of December 28, 2018, by and between Recro Pharma, Inc.
and Athyrium Opportunities III Acquisition LP. *
Incorporated herein by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on
January 4, 2019 (File No. 001-36329).
10.31†
Security Agreement, dated as of November 17, 2017, by Recro
Pharma, Inc. in favor of Athyrium Opportunities III Acquisition LP.
10.32
Sales Agreement, dated as of December 29, 2017, by and between
Recro Pharma, Inc. and Cowen and Company, LLC.
10.33
Common Stock Purchase Agreement, dated March 2, 2018, by and
between Recro Pharma, Inc. and Aspire Capital Fund, LLC.
Incorporated herein by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K filed on
November 20, 2017 (File No. 001-36329).
Incorporated herein by reference to Exhibit 1.1 to the
Company’s Current Report on Form 8-K filed on
December 29, 2017 (File No. 001-36329).
Incorporated herein by reference to Exhibit 10.38 to
the Company’s Annual Report on Form 10-K filed on
March 2, 2018 (File No. 001-36329).
10.34
Common Stock Purchase Agreement, dated February 19, 2019, by
Filed herewith.
and between Recro Pharma, Inc. and Aspire Capital Fund, LLC.
21.1
23.1
23.2
31.1
31.2
32.1
Subsidiaries of Recro Pharma, Inc.
Filed herewith.
Consent of KPMG LLP, Independent Registered Public Accounting
Filed herewith.
Firm.
Consent of Pepper Hamilton LLP.
Included in Exhibit 5.1.
Rule 13a-14(a)/15d-14(a) certification of Principal Executive Officer Filed herewith.
Rule 13a-14(a)/15d-14(a) certification of Principal Financial Officer
Filed herewith.
Section 1350 certification, as adopted pursuant to Section 906 of the
Filed herewith.
Sarbanes-Oxley Act of 2002.
101 INS
XBRL Instance Document
101 SCH XBRL Taxonomy Extension Schema
101 CAL XBRL Taxonomy Extension Calculation Linkbase
101 DEF XBRL Taxonomy Extension Definition Linkbase
101 LAB XBRL Taxonomy Extension Label Linkbase
Filed herewith.
Filed herewith.
Filed herewith.
Filed herewith.
Filed herewith.
•
†
Management contract or compensatory plan or arrangement.
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment pursuant to Rule
406 under the Securities Act of 1933.
(c) Not applicable
90
Item 16.
Form 10-K Summary
None.
91
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report
to be signed on its behalf by the undersigned thereunto duly authorized.
Date: February 19, 2019
SIGNATURES
RECRO PHARMA, INC.
By: /s/ Gerri A. Henwood
Gerri A. Henwood
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, Annual Report on Form 10-K has been signed by
the following persons in the capacities held on the dates indicated.
Signature
/s/ Gerri A. Henwood
Gerri A. Henwood
/s/ Ryan D. Lake
Ryan D. Lake
/s/ Alfred Altomari
Alfred Altomari
/s/ William L. Ashton
William L. Ashton
/s/ Michael Berelowitz
Michael Berelowitz
/s/ Winston J. Churchill
Winston J. Churchill
/s/ Karen Flynn
Karen Flynn
/s/ Bryan M. Reasons
Bryan M. Reasons
/s/ Wayne B. Weisman
Wayne B. Weisman
Date
February 19, 2019
February 19, 2019
February 19, 2019
February 19, 2019
February 19, 2019
February 19, 2019
February 19, 2019
February 19, 2019
February 19, 2019
Title
President, Chief Executive Officer and Director
(Principal Executive Officer)
Chief Financial Officer
(Principal Financial Officer and Principal Accounting
Officer)
Director
Director
Director
Director
Director
Director
Director
92
RECRO PHARMA, INC. AND SUBSIDIARIES
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Loss
Consolidated Statements of Shareholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F-1
Page
F-2
F-3
F-4
F-5
F-6
F-7
Report of Independent Registered Public Accounting Firm
To the Shareholders and Board of Directors
Recro Pharma, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Recro Pharma, Inc. and subsidiaries (the Company) as of December 31,
2018 and 2017, the related consolidated statements of operations and comprehensive loss, shareholders’ equity, and cash flows for each of
the years in the three-year period ended December 31, 2018, and the related notes (collectively, the consolidated financial statements). In
our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of
December 31, 2018 and 2017, and the results of its operations and its cash flows for each of the years in the three-year period ended
December 31, 2018, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company
Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with
the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or
fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As
part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of
expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such
opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial
statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KPMG LLP
We have served as the Company’s auditor since 2009.
Philadelphia, Pennsylvania
February 19, 2019
F-2
RECRO PHARMA, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(amounts in thousands, except share and per share data)
Assets
Current assets:
Cash and cash equivalents
Short-term investments
Accounts receivable
Inventory
Contract asset
Prepaid expenses and other current assets
Total current assets
Property, plant and equipment, net
Deferred income taxes
Intangible assets, net
Goodwill
Total assets
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Current portion of contingent consideration
Total current liabilities
Long-term debt, net
Warrants and other long-term liabilities
Long-term portion of contingent consideration
Total liabilities
Commitments and contingencies (Note 13)
Shareholders’ equity:
Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and
outstanding
Common stock, $0.01 par value. Authorized, 50,000,000 shares; issued and
outstanding, 21,799,961 shares at December 31, 2018 and 19,127,435 shares at
December 31, 2017
Additional paid-in capital
Accumulated deficit
Accumulated other comprehensive loss
Total shareholders’ equity (deficit)
Total liabilities and shareholders’ equity
See accompanying notes to consolidated financial statements.
F-3
December 31, 2018
December 31, 2017
$
$
$
$
38,514 $
—
12,866
10,699
5,201
3,861
71,141
45,640
—
32,266
6,446
155,493 $
4,510 $
14,165
10,354
29,029
64,243
1,163
80,558
174,993
60,984
3,498
9,686
9,839
—
3,276
87,283
39,074
18,573
34,850
6,446
186,226
7,954
9,897
32,053
49,904
53,598
3,516
50,360
157,378
—
—
218
168,535
(188,253 )
—
(19,500 )
155,493 $
191
140,006
(111,348 )
(1 )
28,848
186,226
RECRO PHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Loss
(amounts in thousands, except share and per share data)
Revenue
Operating expenses:
Cost of sales (excluding amortization of intangible assets)
Research and development
General and administrative
Amortization of intangible assets
Change in warrant valuation
Change in contingent consideration valuation
Total operating expenses
Operating loss
Other income (expense):
Interest income
Interest expense
Net loss before income taxes
Income tax benefit (expense)
Net loss
Per share information:
Net loss per share of common stock, basic and diluted
Weighted average common shares outstanding, basic and diluted
For the Year ended December 31,
2017
2018
2016
$
77,347 $
71,834 $
69,337
43,160
39,985
36,879
2,583
284
8,499
131,390
(54,043 )
512
(8,756 )
(62,287 )
(17,436 )
(79,723 ) $
38,193
33,095
25,426
2,583
9
12,839
112,145
(40,311 )
385
(12,034 )
(51,960 )
1,880
(50,080 ) $
37,152
33,278
12,742
2,583
(373 )
9,728
95,110
(25,773 )
49
(5,588 )
(31,312 )
1,107
(30,205 )
(3.90 ) $
20,465,106
(2.63 ) $
19,070,983
(2.82 )
10,721,928
$
$
Net loss
Other comprehensive loss:
$
(79,723 ) $
(50,080 ) $
(30,205 )
Unrealized gain (loss) on available-for-sale securities
Comprehensive loss
1
(79,722 ) $
(1 )
(50,081 ) $
—
(30,205 )
$
See accompanying notes to consolidated financial statements.
F-4
RECRO PHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Shareholders’ Equity
For the Years Ended December 31, 2018, 2017 and 2016
Common Stock
Additional
Shares
Amount
paid-in
capital
Accumulated
Deficit
Accumulated
other
comprehensive
loss
Total
9,224,315 $
92 $
71,321 $
(31,063 ) $
— $
40,350
1,143,940
11
7,364
8,656,666
87
50,168
—
—
18,295
—
—
19,043,216
—
7,756
—
—
—
190
—
—
(51 )
3,889
—
132,691
5,546
53
—
—
(30,205 )
(61,268 )
—
—
—
7,375
—
50,255
—
—
—
—
—
—
(51 )
3,889
(30,205 )
71,613
5,546
53
76,463
1
(250 )
—
—
(249 )
—
—
—
19,127,435
—
—
—
—
191
—
1,966
—
140,006
7,129
—
—
(50,080 )
(111,348 )
—
352,025
4
1,811
122,746
1
(92 )
1,983,040
214,715
—
—
—
20
2
—
—
—
17,005
2,587
89
—
—
—
—
(79,723 )
—
—
—
—
—
(1 )
—
(1 )
—
—
1,966
(1 )
(50,080 )
28,848
7,129
1,815
—
(91 )
—
—
—
1
—
17,025
2,589
89
1
(79,723 )
—
21,799,961 $
—
218 $
—
168,535 $
2,818
(188,253 ) $
—
— $
2,818
(19,500 )
(amounts in thousands, except share data)
Balance, December 31, 2015
Sale of common stock under Aspire
equity facility, net of transaction costs
Sales of common stock in public
offerings, net of offering costs
Issuance of restricted stock units, net of
shares withheld for income taxes
Stock-based compensation expense
Net loss
Balance, December 31, 2016
Stock-based compensation expense
Stock option exercise
Issuance of restricted stock units, net of
shares withheld for income taxes
Warrants issued in financing facility,
net of related tax effect
Other comprehensive loss
Net loss
Balance, December 31, 2017
Stock-based compensation expense
Stock option exercise
Issuance of restricted stock units, net of
shares withheld for income taxes
Sale of common stock under equity
facility, net of transaction costs
Cashless exercise of warrants
Revaluation of equity classified
warrants
Change in other comprehensive loss
Net loss
Cumulative effect of adoption of new
accounting standards, net of tax
Balance, December 31, 2018
See accompanying notes to consolidated financial statements.
F-5
RECRO PHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(amounts in thousands)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
Non-cash interest expense
Depreciation expense
Loss on early extinguishment of debt
Amortization
Acquired in-process research and development charges
Change in warrant valuation
Change in contingent consideration valuation
Deferred income taxes
Changes in operating assets and liabilities, net of effect of acquisition:
Inventory
Contract asset
Prepaid expenses and other current assets
Accounts receivable
Accounts payable, accrued expenses and other liabilities
Net cash used in operating activities
Cash flows from investing activities:
Purchase of property and equipment
Purchase of short-term investments
Proceeds from maturity of investments
Acquisition of license agreement
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from issuance of long-term debt
Payments on long-term debt
Fees related to early extinguishment of debt
Payment of deferred financing costs
Proceeds from sale of common stock, net of transaction costs
Payments of withholdings on shares withheld for income taxes
Proceeds from option exercise
Net cash provided by financing activities
Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents, beginning of year
Cash and cash equivalents, end of year
Supplemental disclosure of cash flow information:
Cash paid for interest
Cash paid for taxes
Purchase of property, plant and equipment included in accrued expenses
and accounts payable
Common stock issued in connection with equity facility
Amortization of deferred equity costs
Fair value recognized for warrants
Withholdings on shares withheld for income taxes included in accrued
expenses
Retirement of fully depreciated property, plant and equipment
See accompanying notes to consolidated financial statements.
F-6
For the Year ended December 31,
2017
2018
2016
$
(79,723 ) $
(50,080 ) $
(30,205 )
7,129
1,287
5,267
—
2,583
—
284
8,499
17,637
(860 )
(1,446 )
(527 )
(3,180 )
(65 )
(43,115 )
(10,526 )
(6,225 )
9,750
(82 )
(7,083 )
10,000
—
—
(961 )
16,965
(91 )
1,815
27,728
(22,470 )
60,984
38,514 $
8,134 $
— $
2,581 $
357 $
332 $
89 $
— $
88 $
5,546
912
4,864
6,772
2,583
766
9
12,839
(1,690 )
(1,093 )
—
(2,158 )
725
2,963
(17,042 )
(6,172 )
(57,124 )
53,500
(519 )
(10,315 )
60,000
(27,347 )
(4,420 )
(4,178 )
—
(250 )
53
23,858
(3,499 )
64,483
60,984
$
5,341
467
1,274
—
—
2,143
233
161
$
$
$
$
$
$
$
$
3,889
1,071
4,993
—
2,583
—
(373 )
9,728
(1,423 )
237
—
(325 )
(1,831 )
8,454
(3,202 )
(3,770 )
—
—
—
(3,770 )
—
(6,324 )
—
—
58,051
(51 )
—
51,676
44,704
19,779
64,483
4,517
—
808
—
421
—
—
—
$
$
$
$
$
$
$
$
$
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(1)
Background
Recro Pharma, Inc., or the Company, was incorporated in Pennsylvania on November 15, 2007. The Company is a specialty
pharmaceutical company that operates through two business segments: an Acute Care segment and a revenue-generating contract
development and manufacturing, or CDMO segment. Each of these segments are deemed to be reportable segments (see Note 3(m)
and Note 17). The Acute Care segment is primarily focused on developing innovative products for hospital and other acute care
settings, and the CDMO segment leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products
using the Company’s proprietary delivery technologies for commercial partners who commercialize or plan to commercialize these
products. On April 10, 2015, the Company acquired from Alkermes plc, or Alkermes, worldwide rights to intravenous and
intramuscular, or injectable, meloxicam, a proprietary long-acting preferential COX-2 inhibitor being developed for the management of
moderate to severe pain, as well as a contract manufacturing facility, royalty and formulation business in Gainesville, Georgia. The
acquisition is referred to herein as the Gainesville Transaction. In July 2017, the Company submitted a New Drug Application, or
NDA, to the U.S. Food and Drug Administration, or the FDA, for its lead investigational product candidate intravenous, or IV,
meloxicam 30 mg for the management of moderate to severe pain. In May 2018, the Company received a Complete Response Letter,
or CRL, from the FDA regarding its NDA for IV meloxicam. In July 2018, the Company participated in a Type A End-of-Review
meeting with the FDA to discuss the topics covered in the CRL. Upon receipt and review of the meeting minutes, the Company
resubmitted the NDA for IV meloxicam in September 2018. The FDA has set a date for decision on the NDA under the Prescription
Drug User Fee Act, or PDUFA, of March 24, 2019.
(2) Development-Stage Risks and Liquidity
The Company has incurred losses from operations since inception and has an accumulated deficit of $188,253 as of December 31,
2018. Though its CDMO segment has been profitable, the Company anticipates incurring additional losses until such time, if ever, that
it can generate significant sales of its products currently in development. Additional financing will be needed by the Company to fund
its operations and to commercially develop its product candidates, including the payment of the Gainesville Transaction contingent
payments, which may become due upon achievement of certain development and commercialization milestones for meloxicam (see
Note 4). Insufficient funds may cause the Company to delay, reduce the scope of or eliminate one or more of its development,
commercialization or expansion activities. The Company may raise such funds through debt refinancing, bank or other loans, sale of
assets, through strategic research and development, licensing (including out-licensing) and/or marketing arrangements or through
public or private sales of equity or debt securities from time to time. Financing may not be available on acceptable terms, or at all, and
failure to raise capital when needed could materially adversely impact the Company’s growth plans and its financial condition or
results of operations. Additional equity financing, if available, may be dilutive to the holders of its common stock and may involve
significant cash payment obligations and covenants that restrict the Company’s ability to operate its business. The Company’s future
operations are highly dependent on a combination of factors, including (i) the continued profitability of the CDMO segment; (ii) the
timely and successful completion of additional financing and/or alternative sources of capital, debt, partnering or out-licensing
transactions; (iii) the success of its research and development, including the results and timing of its clinical trials; (iv) the development
of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately, (v) regulatory approval and market
acceptance of the Company’s proposed future products, including IV meloxicam. Management believes that it is probable that the
Company will be able to meet its obligations as they become due within one year after the date the financial statements are issued.
(3)
Summary of Significant Accounting Principles
(a)
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements of the Company and its subsidiaries have been prepared in accordance
with U.S. generally accepted accounting principles, or U.S. GAAP. The Company’s consolidated financial statements include
the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been
eliminated.
In the opinion of management, the accompanying consolidated financial statements include all normal and recurring
adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered
necessary to present fairly the Company’s financial position as of December 31, 2018 and 2017 and its results of operations for
the twelve months ended December 31, 2018, 2017 and 2016 and cash flows for the twelve months ended December 31, 2018,
2017 and 2016.
F-7
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(b) Use of Estimates
The preparation of financial statements and the notes to the financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from such estimates.
(c)
Cash and Cash Equivalents
Cash and cash equivalents represents cash in banks and highly liquid short-term investments that have maturities of three
months or less when acquired to be cash equivalents. These highly liquid short-term investments are both readily convertible to
known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of the changes
in interest rates.
(d)
Property and Equipment
Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are
computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for
furniture and office equipment; six to ten years for manufacturing equipment; two to five years for vehicles; 35 to 40 years for
buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance cost are
expensed as incurred.
(e)
Business Combinations
In accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 805,
“Business Combinations,” or ASC 805, the Company allocates the purchase price of acquired companies to the tangible and
intangible assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in
determining the fair values of assets acquired and liabilities assumed, which requires management to make significant estimates
and assumptions, in particular with respect to intangible assets and contingent consideration. Management makes estimates of
fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and
information obtained from management of the acquired companies and expectations of future cash flows. Transaction costs and
restructuring costs associated with the transaction are expensed as incurred. In-process research and development, or IPR&D, is
the value assigned to those projects for which the related products have not received regulatory approval and have no alternative
future use. Determining the portion of the purchase price allocated to IPR&D requires the Company to make significant
estimates. In a business combination, the Company capitalizes IPR&D as an intangible asset, and for an asset acquisition the
Company expenses IPR&D in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date
(f)
Goodwill and Intangible Assets
Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not
amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment
model prescribes a one-step method for determining impairment.
The one-step quantitative test calculates the amount of goodwill impairment as the excess of a reporting unit’s carrying amount
over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit.
Intangible assets include the Company’s royalties and contract manufacturing relationships intangible asset as well as an IPR&D
asset. The royalties and contract manufacturing relationships intangible asset is considered a definite-lived intangible asset and is
amortized on a straight-line basis over a useful life of six years.
Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or
more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets
will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations and
Comprehensive Loss. For those compounds that reach commercialization, the IPR&D assets will be amortized over their
estimated useful lives.
F-8
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The impairment test for indefinite-lived intangible assets is a one-step test, which compares the fair value of the intangible asset
to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the
excess. Based on accounting standards, it is required that these assets be assessed at least annually for impairment unless a
triggering event occurs between annual assessments, which would then require an assessment in the period which a triggering
event occurred.
The Company performs its annual goodwill and indefinite-lived intangible asset impairment test as of November 30th, or
whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. In
performing the evaluation the Company assesses qualitative factors such as overall financial performance of its reporting units,
anticipated changes in industry and market conditions, including recent tax reform, and competitive environments. Due to the
receipt of the CRL in May 2018, an indicator of potential impairment, the Company performed an impairment test as of June 30,
2018, which indicated that there was no impairment to goodwill or indefinite-lived intangible assets. The Company additionally
performed impairment tests as of November 30, 2018 and noted there have been no further triggering events or indicators of
impairment as of December 31, 2018. As a result of the impairment tests, the Company determined that there was no
impairment to goodwill or indefinite-lived intangible assets for the year ended December 31, 2018.
(g)
Revenue Recognition
The Company generates revenues from manufacturing, packaging, research and development, and related services for multiple
pharmaceutical companies through its CDMO segment. The agreements that the Company has with its commercial partners
provide for manufacturing revenues, sales-based royalties and/or profit sharing components. The Company’s revenue policies
listed below are reflective of Accounting Standards Update, or ASU, No. 2014-09, “ Revenue from Contracts with Customers,”
or ASU 2014-09, which the Company adopted effective January 1, 2018. See Note 18 for additional information regarding the
Company’s adoption of ASU 2014-09 and its impact on the Company’s financial statements.
Manufacturing and other related services revenue is recognized upon transfer of control of a product to a customer, generally
upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in
the agreement with the commercial partner, which could include pricing and volume-based adjustments.
In addition to manufacturing and packaging revenue, certain customer agreements may have intellectual property sales-based
royalties and/or profit sharing consideration, collectively referred to as royalties, computed on the net product sales of the
commercial partner. Royalty revenues are generally recognized under the terms of the applicable license, development and/or
supply agreement. For arrangements that include sales-based royalties where the license for intellectual property is deemed to be
the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur by the
commercial partner. For arrangements that include sales-based royalties where the license for intellectual property is not
deemed to be the predominant item to which the royalties relate, the Company recognizes revenue upon transfer of control of
the manufactured product. In these cases, significant judgment is required to calculate this estimated variable consideration
using the most-likely amount method based on historical customer pricing and deductions and is partially constrained due to
items that are outside of the Company’s control including the uncertainty of the timing of future commercial partner sales, mix
of volume, customer stocking and ordering patterns, as well as unforeseen price adjustments made by the Company’s
commercial partners.
Revenues related to research and development for our CDMO segment are generally recognized over-time as the related
services or activities are performed using the output method and in accordance with the contract terms. In agreements which
specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the
amount to be included in the transaction price using the most likely amount method. Milestone payments related to
arrangements under which the Company has continuing performance obligations would be deferred and recognized over the
period of performance. Milestone payments that are not within the control of the Company, such as submission for approval to
regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those
submissions are submitted by the customer or approvals are received.
F-9
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(h) Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash,
cash equivalents, short-term investments and accounts receivable. The Company manages its cash, cash equivalents and short-
term investments based on established guidelines relative to diversification and maturities to maintain safety and liquidity.
The Company’s accounts receivable balances are concentrated amongst approximately five customers and if any of these
customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results
of operations and financial condition.
The Company’s CDMO segment is dependent on its relationships with a small number of commercial partners, with its four
largest customers having generated 99% of its revenues for the year ending December 31, 2018. A portion of the Company’s
revenues are dependent on U.S. based customers selling to end-users outside the U.S.
(i)
Research and Development
Research and development costs for the Company’s proprietary products/product candidates are charged to expense as incurred.
Research and development expenses consist primarily of funds paid to third parties for the provision of services for pre-
commercialization and manufacturing scale-up activities, drug development, clinical trials, statistical analysis and report writing
and regulatory filing fees and compliance costs. At the end of the reporting period, the Company compares payments made to
third-party service providers to the estimated progress toward completion of the research or development objectives. Such
estimates are subject to change as additional information becomes available. Depending on the timing of payments to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company
may record net prepaid or accrued expenses relating to these costs.
Upfront and milestone payments made to third parties who perform research and development services on the Company’s
behalf are expensed as services are rendered. Costs incurred in obtaining product technology licenses are charged to research
and development expense as acquired IPR&D if the technology licensed has not reached technological feasibility and has no
alternative future use.
(j)
Stock-Based Awards
The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense
on a straight-line basis over the vesting period of the award.
Determining the appropriate fair value of stock options requires the input of subjective assumptions, including the expected life
of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock
option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates
and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or
management uses different assumptions, stock-based compensation expense could be materially different for future awards.
The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical
information to develop reasonable expectations about future exercise patterns and post-vesting employment termination
behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual
life of each grant. For stock price volatility, the Company uses the historical volatility of our publicly traded stock in order to
estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the
expected life of the option.
During the year ending December 31, 2016, the Company adopted ASU 2016-09, “ Compensation—Stock Compensation (Topic
718) Improvements to Employee Share-Based Payment Accounting” and elected to account for forfeitures as they occur.
For non-employee stock-based awards, the Company recognizes compensation expense on a straight-line basis over the vesting
period of each separated vesting tranche of the award, which is known as the accelerated attribution method. The estimation of
the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates
differ from the Company’s current estimates, such amounts are recognized as an adjustment in the period in which estimates are
revised.
F-10
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(k)
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the
future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and
liabilities and their respective tax basis, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are
expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in
operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than
not that some portion or all of the deferred tax assets will not be realized.
Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in
the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely
than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of
the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that
has a greater than 50% likelihood of being realized upon ultimate settlement. The Company does not anticipate significant
changes in the amount of unrecognized income tax benefits over the next year.
(l)
Net Loss Per Common Share
Basic net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average
common shares outstanding during the period. For the years ending December 31, 2018, 2017 and 2016, the outstanding
common stock options, warrants and unvested restricted stock units have been excluded from the calculation of diluted net loss
per share because their effect would be anti-dilutive.
For purposes of calculating diluted loss per common share, the denominator includes both the weighted average common shares
outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents would be dilutive.
The following table sets forth the computation of basic and diluted loss per share:
Basic Loss Per Share
Net loss
Weighted average common shares outstanding,
basic and diluted
Net loss per share of common stock, basic and
diluted
Year ended December 31,
2017
2018
2016
$
(79,723 ) $
(50,080 ) $
(30,205 )
20,465,106 19,070,983 10,721,928
$
(3.90 ) $
(2.63 ) $
(2.82 )
The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares
outstanding as of December 31, 2018, 2017 and 2016 as they would be anti-dilutive:
Options and restricted stock units outstanding
Warrants
2018
December 31,
2017
4,878,461 3,865,468 2,619,679
838,664 1,133,592 784,928
2016
Amounts in the table above reflect the common stock equivalents of the noted instruments.
(m) Segment Information
The Company determined its reportable segments based on its strategic business units, the commonalities among the products
and services within each segment and the manner in which the Company reviews and evaluates operating performance. The
Company has identified CDMO and Acute Care as reportable segments. Segment disclosures are included in Note 17. Segment
operating profit (loss) is defined as segment revenue less segment operating expenses (segment operating expenses consist of
general and administrative expenses, research and development expenses, and the change in valuation of contingent
consideration and warrants). The following items are excluded from segment operating profit (loss): interest income and
expense, and income tax benefit (expense). Segment assets are those assets and liabilities that are recorded and reported by
segment operations.
F-11
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(n) Recent Accounting Pronouncements
Recently Adopted Accounting Pronouncements
In June 2018, the FASB issued ASU No. 2018-07, “ Compensation – Stock Compensation (Topic 718)” or ASU 2018-07. ASU
2018-07 simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based
payments to employees, with certain exceptions. The new guidance expands the scope of ASC 718 “Compensation—Stock
Compensation” to include share-based payments granted to nonemployees in exchange for goods or services used or consumed
in an entity’s own operations and supersedes the guidance in ASC 505-50 “ Equity-Based Payments to Non-Employees”. The
guidance is effective for public business entities in annual periods beginning after December 15, 2018, and interim periods
within those annual periods. Early adoption is permitted, including in an interim period for which financial statements have not
been issued, but not before an entity adopts ASU 2014-09 “Revenue from Contracts with Customers (Topic 606) ”. The
Company adopted this guidance effective June 30, 2018. There was no impact upon adoption.
In May 2017, the FASB issued ASU No. 2017-09, “ Stock Compensation – Scope of Modification Accounting” or ASU 2017-
09. ASU 2017-09 provides guidance on which changes to the terms or conditions of a share-based payment award require an
entity to apply modification accounting. The new standard was effective for fiscal years beginning after December 15, 2017.
The Company adopted the guidance effective January 1, 2018. There was no impact upon adoption.
In January 2017, the FASB issued ASU No. 2017-04 “ Intangibles – Goodwill and Other (Topic 350): Simplifying the
Accounting for Goodwill Impairment,” or ASU 2017-04. ASU 2017-04 allows companies to apply a one-step quantitative test
and record the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to
exceed the total amount of goodwill allocated to the reporting unit. The amendments of the ASU are effective for annual or
interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or
annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company adopted this guidance as of
October 1, 2018 and there was no impact on its consolidated financial statements.
In May 2014, the FASB issued ASU 2014-09. ASU 2014-09 represents a comprehensive new revenue recognition model that
requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that
reflects the consideration to which a company expects to be entitled to receive in exchange for those goods or services. This
ASU sets forth a new five-step revenue recognition model that replaces the prior revenue recognition guidance in its entirety and
is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In
January 2018, the Company adopted the standard using the modified retrospective method. See Note 18 for additional
information on the impact of the transition on the Company’s financial statements
Accounting Pronouncements Not Yet Adopted
In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework—Changes to
the Disclosure Requirements for Fair Value Measurement,” or ASU 2018-13. ASU 2018-13 removes, modifies and adds certain
disclosure requirements in Topic 820 “ Fair Value Measurement”. ASU 2018-13 eliminates certain disclosures related to
transfers and the valuations process, clarifies the measurement uncertainty disclosure, and requires additional disclosures for
Level 3 fair value measurements, including the range and weighted average of significant unobservable inputs used to develop
Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years, and interim periods within those fiscal years,
beginning after December 15, 2019, with early adoption permitted. The Company is currently evaluating the potential impact on
its disclosures.
In February 2016, the FASB issued ASU No. 2016-02, “ Leases (Topic 842),” or ASU 2016-02. ASU 2016-02 establishes a
wholesale change to lease accounting and introduces a lease model that brings most leases on the balance sheet. It also
eliminates the required use of bright-line tests in current U.S. GAAP for determining lease classification. In July 2018, the
FASB issued ASU No. 2018-11, Leases (Topic 842), Targeted Improvements, which provides an alternative transition method
permitting the recognition of a cumulative-effect adjustment to retained earnings on the date of adoption rather than restating
comparative periods in transition as originally prescribed by Topic 842. The new guidance is effective for annual and interim
periods beginning after December 15, 2018, with early adoption permitted. The Company plans to adopt this ASU in the first
quarter of 2019. The Company will elect the optional transition method to account for the impact of the adoption with a
cumulative-effect adjustment in the period of adoption and will not restate prior periods. The Company expects to elect certain
practical expedients permitted under the transition guidance. The Company currently expects that most of its operating lease
commitments will be subject to the update and recognized as operating lease liabilities and right-of-use assets upon adoption.
The Company expects total assets and total liabilities will materially
F-12
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
increase in the period of adoption in the range of $1.5 to $2.5 million. The Company is in the final stages of evaluating the
impact the adoption of this accounting standard will have on its results of operations, cash flows and related disclosures. The
Company continues to assess any potential impacts on its internal controls, business processes, and accounting policies related
to both the implementation and ongoing compliance of the new guidance.
(4) Acquisition of Gainesville Facility and Meloxicam
On April 10, 2015, the Company completed the Gainesville Transaction. The consideration paid in connection with the Gainesville
Transaction consisted of $50,000 cash at closing, a $4,000 working capital adjustment and a seven-year warrant to purchase 350,000
shares of the Company’s common stock at an exercise price of $19.46 per share, according to the original agreement. In addition,
according to the original agreement, the Company may be required to pay up to an additional $125,000 in milestone payments
including $45,000 upon regulatory approval, as well as net sales milestones related to injectable meloxicam and a percentage of future
product net sales related to injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by
patent). Under the acquisition method of accounting, the consideration paid and the fair value of the contingent consideration and
royalties are allocated to the fair value of the assets acquired and liabilities assumed. The contingent consideration obligation is
remeasured each reporting date with changes in fair value recognized as a period charge within the statement of operations (see Note 6
for further information regarding fair value).
In December 2018, the Company entered in to an Amendment to the Purchase and Sale Agreement that restructured the $45,000
milestone to $60,000 therefore increasing the amount the Company may be required to pay Alkermes to $140,000, however, the
amendment spread the payments of the development milestone over a seven year period. In addition, the Company amended the
warrant agreement with Alkermes, which decreased the exercise price of the warrant to $8.26 per share.
Based on the amended terms of the Alkermes agreement, the contingent consideration consists of four separate components. The first
component is (i) a $5,000 payment due January 19, 2019 (30 days after signing such amendment) and (ii) a $5,000 payment due by
April 23, 2019. The second components will be payable upon certain regulatory approval and include (i) a $5,000 payment due within
180 days following regulatory approval for IV meloxicam and (ii) $45,000 payable in seven equal annual payments of approximately
$6,400 beginning on the first anniversary of such approval. The third component consists of three potential payments, based on the
achievement of specified annual revenue targets, the last of which represents over 60% of these milestone payments and currently does
not have a fair value assigned to its achievement. The fourth component consists of a royalty payment between 10% and 12% (subject
to a 30% reduction when no longer covered by patent) for a defined term on future meloxicam net sales.
The fair value of the first and second contingent consideration components is estimated by applying a risk-adjusted discount rate to the
probability-adjusted contingent payments and the expected approval dates. The fair value of the third contingent consideration
component is estimated using the Monte Carlo simulation method and applying a risk-adjusted discount rate to the potential payments
resulting from probability-weighted revenue projections based upon the expected revenue target attainment dates. The fair value of the
fourth contingent consideration component is estimated by applying a risk-adjusted discount rate to the potential payments resulting
from probability-weighted revenue projections and the defined royalty percentage.
These fair values are based on significant inputs not observable in the market, which are referred to in the guidance as Level 3 inputs.
The contingent consideration components are classified as liabilities and are subject to the recognition of subsequent changes in fair
value through the results of operations.
(5) NMBA Related License Agreement
In June 2017, the Company acquired the exclusive global rights to two novel neuromuscular blocking agents, or NMBAs, and a
proprietary chemical reversal agent from Cornell University, or Cornell. The NMBAs and reversal agent are referred to herein as the
NMBA Related Compounds. The NMBA Related Compounds include one novel intermediate-acting NMBA that has initiated Phase I
clinical trials and two other agents, a novel short-acting NMBA, and a rapid-acting reversal agent proprietary to these NMBAs.
The transaction was accounted for as an asset acquisition, with the total cost of the acquisition of $766 allocated to acquired IPR&D.
The Company recorded an upfront payment obligation of $350, as well as operational liabilities and acquisition-related costs of $416,
primarily consisting of reimbursement to Cornell for specified past patent, legal and pre-clinical costs.
F-13
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
In addition, the Company is obligated to make: (i) an annual license maintenance fee payment until the first commercial sale of the
NMBA Related Compounds; and (ii) milestone payments upon the achievement of certain milestones, up to a maximum, for each
NMBA, of $5,000 for U.S. regulatory approval and commercialization milestones and $3,000 for European regulatory approval and
commercialization milestones. The Company is also obligated to pay Cornell royalties on net sales of the NMBA Related Compounds
at a rate ranging from low to mid-single digits, depending on the applicable NMBA Related Compounds and whether there is a valid
patent claim in the applicable country, subject to an annual minimum royalty amount. Further, the Company will reimburse Cornell
ongoing patent costs related to prosecution and maintenance of the patents related to the Cornell patents for the NMBA Related
Compounds.
The Company accounted for the transaction as an asset acquisition based on an evaluation of the accounting guidance (ASC Topic
805) and considered the early clinical stage of the novel and unproven NMBA Related Compounds. The Company concluded that the
acquired IPR&D of Cornell did not constitute a business as defined under ASC 805 due to the incomplete nature of the inputs and the
absence of processes from a market participant perspective. Substantial additional research and development will be required to
develop any NMBA Related Compounds into a commercially viable drug candidate, including completion of pre-clinical testing and
clinical trials, and, if such clinical trials are successful, application for regulatory approvals and manufacturing repeatability and scale-
up. There is risk that a marketable compound may not be well tolerated and may never be approved.
Acquired IPR&D in the asset acquisition was accounted for in accordance with FASB ASC Topic 730, “ Research and Development.”
At the date of acquisition, the Company determined that the development of the projects underway at Cornell had not yet reached
technological feasibility and that the research in process had no alternative future uses. Accordingly, the acquired IPR&D was
charged to expense in the Consolidated Statements of Operations and Comprehensive Loss on the acquisition date. The acquired
IPR&D charge is expected to be deductible over a 15-year period for income tax purposes.
(6)
Fair Value of Financial Instruments
The Company follows the provisions of FASB ASC Topic 820, “ Fair Value Measurements and Disclosures ,” for fair value
measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at
fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis,
including cash equivalents, short-term investments, warrants and the contingent consideration. The Company’s assessment of the
significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and
financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy,
which prioritizes the inputs used in measuring fair value, as follows:
•
•
•
Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted
prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly
observable; and
Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own
assumptions.
F-14
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The Company has classified assets and liabilities measured at fair value on a recurring basis as follows:
At December 31, 2017:
Assets:
Cash equivalents
Money market mutual funds (See Note 7)
Total cash equivalents
Short-term investments
U.S. Treasury obligations (See Note 7)
Total financial assets
Liabilities:
Warrants (See Note 14(d))
Contingent consideration (See Note 4)
At December 31, 2018:
Assets:
Cash equivalents
Money market mutual funds (See Note 7)
Commercial paper (See Note 7)
U.S. Treasury obligations (See Note 7)
Total cash equivalents
Liabilities:
Warrants (See Note 14(d))
Contingent consideration (See Note 4)
Fair value measurements at reporting
date using
Quoted prices
in active
markets for
identical
assets
(Level 1)
Significant
other
observable
inputs
(Level 2)
Significant
unobservable
inputs
(Level 3)
$
$
$
$
$
$
$
$
$
$
38,959 $
38,959 $
3,498 $
42,457 $
— $
—
— $
— $
— $
— $
— $
— $
—
— $
—
—
—
—
3,406
82,413
85,819
24,720 $
—
2,748
27,468 $
— $
2,247
—
2,247 $
—
—
—
—
— $
—
— $
— $
—
— $
1,101
90,912
92,013
The Company developed its own assumptions to determine the value of the warrants that do not have observable inputs or available
market data to support the fair value. This method of valuation involves using inputs such as the fair value of the Company’s common
stock, stock price volatility, the contractual term of the warrants, risk free interest rates and dividend yield. Due to the nature of these
inputs, the valuation of the warrants is considered a Level 3 measurement.
The reconciliation of the contingent consideration and warrants measured at fair value on a recurring basis using unobservable inputs
(Level 3) is as follows:
Balance at December 31, 2016
Additions
Remeasurement
Balance at December 31, 2017
Exercise of warrants
Remeasurement
Total at December 31, 2018
Warrants
$
Contingent Consideration
69,574
—
12,839
82,413
—
8,499
90,912
3,397 $
—
9
3,406 $
(2,589 )
284
1,101 $
$
$
Current portion as of December 31, 2018
Long-term portion as of December 31, 2018
—
1,101
10,354
80,558
F-15
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The current portion of the contingent consideration represents the estimated probability adjusted fair value that is expected to become
payable within one year as of December 31, 2018 (see Note 4 for additional information). The Company plans to reevaluate this
classification as it progresses discussions with the FDA regarding the September 2018 resubmission of its NDA and approaches the
new PDUFA date of March 24, 2019.
The Company follows the disclosure provisions of FASB ASC Topic 825, “ Financial Instruments” (ASC 825), for disclosure
purposes for financial assets and financial liabilities that are not measured at fair value. As of December 31, 2018, the financial assets
and liabilities recorded on the Consolidated Balance Sheets that are not measured at fair value on a recurring basis include accounts
receivable, accounts payable and accrued expenses and approximate fair value due to the short-term nature of these instruments. The
fair value of long-term debt, where a quoted market price is not available, is evaluated based on, among other factors, interest rates
currently available to the Company for debt with similar terms, remaining payments and considerations of the Company’s
creditworthiness. The Company determined that the recorded book value of long-term debt approximated fair value at December 31,
2018 due to the comparison of the terms of the debt, including borrowing rates available to the Company through its recently
completed debt refinancing process, availability of additional term loan tranches, and maturity.
(7) Cash Equivalents and Short-term Investments
Cash equivalents as of December 31, 2018 consist of government money market funds, commercial paper and U.S. Treasury
obligations. In accordance with FASB ASC Topic 320, “ Investments – Debt and Equity Securities,” or ASC 320, the Company
classified its entire investment portfolio as of December 31, 2017 as available-for-sale securities with secondary or resale markets, and,
as such, its portfolio was reported at fair value with unrealized gains and losses included in Comprehensive Loss in stockholders’
equity and realized gains and losses included in other income. The following is a summary of cash equivalents and available-for-sale
securities:
Description
Money market mutual funds
Commercial paper
U.S. Treasury obligations
Total cash equivalents
Description
Money market mutual funds
U.S. Treasury obligations
Total investments
Amortized
Cost
December 31, 2018
Gross Unrealized
Loss
Gain
$ 24,720 $ — $ — $
—
—
1
—
1 $ — $
2,247
2,747
$ 29,714 $
Estimated
Fair Value
24,720
2,247
2,748
29,715
Amortized
Cost
December 31, 2017
Gross Unrealized
Loss
Gain
$ 38,959 $ — $ — $
(1 )
(1 ) $
—
$ 42,458 $ — $
Estimated
Fair Value
38,959
3,498
42,457
3,499
As of December 31, 2018 and 2017, the Company’s cash equivalents and investments had maturities ranging from one to two months.
The fair value of the Company’s U.S. Treasury obligations is determined by taking into consideration valuations obtained from third-
party pricing services. The third-party pricing services utilize industry standard valuation models, for which all significant inputs are
observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the
same or similar securities, issuer credit spreads, benchmark securities, and other observable inputs. To derive the fair value of its
commercial paper, the Company uses benchmark inputs and industry standard analytical models.
F-16
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(8)
Inventory
Inventory is stated at the lower of cost and net realizable value. Included in inventory are raw materials and work-in-process used in
the production of commercial products. Cost is determined using the first-in, first-out method. The Company expenses costs related to
inventory until such time as it receives approval from the FDA to market a product, at which time the Company commences
capitalization of costs relating to that product.
Inventory was as follows as of December 31, 2018 and 2017:
Raw materials
Work in process
Finished goods
Provision for inventory obsolescence
December 31,
2018
December 31,
2017
$
$
2,611 $
4,935
3,440
10,986
(287 )
10,699 $
2,130
3,931
4,488
10,549
(710 )
9,839
Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or
impaired balances. Inventory is primarily ordered to meet specific customer orders and largely reflects demand. Factors influencing
inventory obsolescence include changes in demand, product life cycle, product pricing, physical deterioration and quality concerns.
(9)
Property, Plant and Equipment
Property, plant and equipment consists of the following:
Land
Building and improvements
Furniture, office and computer equipment
Manufacturing equipment
Construction in progress
Less: accumulated depreciation and amortization
Property, plant and equipment, net
December 31,
2018
December 31,
2017
$
$
3,263 $
17,880
7,226
30,197
6,078
64,644
19,004
45,640 $
3,263
15,751
5,168
23,391
5,326
52,899
13,825
39,074
Depreciation expense for the years ended December 31, 2018, 2017 and 2016 was $5,267, $4,864 and $4,993, respectively.
(10)
Intangible Assets
The following represents the balance of the intangible assets at December 31, 2018:
Cost
Royalties and contract manufacturing relationships
In-process research and development
Total
$
$
15,500 $
26,400
41,900 $
Accumulated
Amortization Net Intangible Assets
5,866
26,400
32,266
9,634 $
—
9,634 $
The following represents the balance of intangible assets at December 31, 2017:
Cost
Royalties and contract manufacturing relationships
In-process research and development
Total
$
$
F-17
Accumulated
Amortization Net Intangible Assets
8,450
26,400
34,850
7,050 $
—
7,050 $
15,500 $
26,400
41,900 $
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Amortization expense each year for the years ended December 31, 2018, 2017 and 2016 was $2,583. The amortization expense for the
next two years will be $2,583 per year and $700 in the final year.
(11) Accrued Expenses
Accrued expenses consist of the following:
Clinical trial and related costs
Professional and consulting fees
Payroll and related costs
Property plant and equipment
Deferred revenue
Interest payable
Pre-commercialization scale-up costs
Other research and development costs
Other
(12) Long-Term Debt
December 31,
December 31,
2018
2017
$
$
683 $
672
4,782
1,737
66
—
4,445
678
1,102
14,165 $
383
1,010
6,387
216
546
802
—
—
553
9,897
On November 17, 2017, the Company entered into a $100,000 Credit Agreement, or the Credit Agreement, with Athyrium
Opportunities III Acquisition LP, or Athyrium. The Credit Agreement provides for a term loan in the original principal amount of
$60,000 funded at closing. In December 2018, the Company amended the Credit Agreement, ( as amended, the “Amended Credit
Agreement”). Pursuant to the Amended Credit Agreement, the $20,000 term B loan and $20,000 term C loan provided for under the
Credit Agreement, which were contingent on the Company receiving approval of IV meloxicam by December 31, 2018, were
restructured into (i) a $10,000 term B-1 loan, funded on December 28, 2018; (ii) a $15,000 term B-2 loan, the B-2 Loan; and (iii) a
$15,000 term C loan, the Term C Loan. The Term B-2 Loan may be drawn upon on or before September 30, 2019 provided that the
Company receives regulatory approval of IV meloxicam and will have at least $20,000 in unrestricted cash after payment of the
milestone payment due to Alkermes. The Term C Loan may be drawn upon at any time on or prior to March 31, 2020 provided that
the Term B-2 loan has been drawn upon and net sales of IV Meloxicam achieve $20,000 for the most recent trailing twelve-month
period. The maturity date of the Credit Agreement is November 17, 2022, the five-year anniversary of the closing.
The Term Loans will bear interest at a rate equal to the three-month LIBOR rate, with a 1% floor plus 9.75% per annum, with
quarterly, interest-only payments until the maturity date. The unpaid principal amount of the Term Loans is due and payable on the
maturity date. In addition, in accordance with the Credit Agreement the Company will have to pay a 1% exit fee, which at the current
outstanding loan balance is $700, and is being accreted to the carrying amount of the debt using the effective interest method over the
term of the loan. In addition, if there is an early repayment, there is a sliding scale of prepayment penalties beginning with a 10%
penalty and including a make-whole interest payment through the anniversary of the first two years.
The Amended Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial
covenants that the Company will need to satisfy on a monthly and quarterly basis. As of December 31, 2018, the Company was in
compliance with the covenants.
As of December 31, 2018, the remaining payments due under the Amended Credit Agreement include a principal payment of $70,000
and an exit fee of $700 due at the maturity date.
In connection with the Credit Agreement, the Company issued warrants to each of Athyrium and its affiliate, Athyrium Opportunities
II Acquisition LP, or Athyrium II, to purchase an aggregate of 348,664 shares of the Company’s common stock, with an exercise price
of $8.6043 per share. In connection with the Amended Credit Agreement, the warrants were amended to decrease the exercise price to
$6.84 per share. See Note 14(d) for additional information. The warrants are exercisable through November 17, 2024. The initial fair
value of the warrant and revaluation adjustment from the repricing of the warrants of $2,232 was recorded as debt issuance costs.
F-18
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
In addition, the Company recorded debt issuance costs for the Amended Credit Agreement of $4,439 at original signing and an
amendment fee of $500 as well as certain other fees and expenses in December 2018, which, along with the fair value of warrants, are
being amortized using the effective interest method over the term of the Amended Credit Agreement. Debt issuance cost amortization
is included in interest expense within the Consolidated Statements of Operations and Comprehensive Loss. As of December 31, 2018,
the effective interest rate was 16%, which takes into consideration the non-cash accretion of the exit fee and the amortization of the
debt issuance costs.
The components of the carrying value of the debt as of December 31, 2018, are detailed below:
Principal balance outstanding
Unamortized deferred issuance costs
Exit fee accretion
Total
$
$
70,000
(5,893 )
136
64,243
The Company used proceeds from the Credit Agreement to (i) repay in full all outstanding indebtedness under its previous credit
facility, dated April 10, 2015, between the Company’s subsidiary, Recro Gainesville LLC and OrbiMed Royalty Opportunities II, LP,
or the OrbiMed Credit Agreement of $31,767, which included the remaining debt principal balance of $27,347 and early termination
charges of $4,420 and (ii) pay transaction fees associated with the Credit Agreement of $4,178.
Associated with the refinancing of the OrbiMed Credit Agreement and in accordance with ASC 405-20 “Extinguishments of
Liabilities”, in the twelve months ended December 31, 2017, the Company recorded a loss on extinguishment of $6,772, which is
reflected in the interest expense line within the Consolidated Statement of Operations and Comprehensive Loss.
The Company recorded debt issuance cost amortization related to the credit agreements of $1,313 , $771 and $907, for the years ended
of December 31, 2018, 2017 and 2016, respectively.
(13) Commitments and Contingencies
(a)
License and Supply Agreements
The Company is party to an exclusive license with Orion for the development and commercialization of Dexmedetomidine,
or Dex, for use in the treatment of pain in humans in any dosage form for transdermal, transmucosal (including sublingual and
intranasal), topical, enteral or pulmonary (inhalational) delivery, but specifically excluding delivery vehicles for
administration by injection or infusion, worldwide, except for Europe, Turkey and the CIS (currently includes Armenia,
Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and
Uzbekistan), referred to herein as the Territory. The Company is required to pay Orion lump sum payments of up to €20,500
($23,460 as of December 31, 2018) on the achievement of certain developmental and commercial milestones, as well as a
royalty on net sales during the term, which varies from 10% to 20% depending on annual sales levels. Through December 31,
2018, no such milestones have been achieved.
The Company is also party to an exclusive license agreement with Orion for the development and commercialization of
Fadolmidine, or Fado, for use as a human therapeutic, in any dosage form in the Territory. The Company is required to pay
Orion lump sum payments of up to €12,200 ($13,961 as of December 31, 2018) on achievement of certain developmental and
commercial milestones, as well as a royalty on net sales during the term, which varies from 10% to 15% depending on annual
sales levels. Through December 31, 2018, no such milestones have been achieved.
F-19
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The Company is party to a license agreement with Cornell University for the exclusive license of the NMBA Related
Compounds. Under the terms of the agreement, the Company will pay Cornell an initial upfront fee and Cornell is also entitled
to receive additional milestone payments, annual license maintenance fees as well as royalties. See Note 5 for further
information regarding these payment obligations.
(b)
Contingent Consideration for the Gainesville Transaction
Pursuant to the purchase and sale agreement and subsequent amendment governing the Gainesville Transaction, the Company
agreed to pay to Alkermes up to an additional $140,000 in milestone payments including $50,000 upon regulatory approval
payable over a seven year period, as well as net sales milestones related to injectable meloxicam and royalties on future product
sales of injectable meloxicam between 10% and 12% (subject to a 30% reduction when no longer covered by patent).
The Company is party to a Development, Manufacturing and Supply Agreement, or Supply Agreement, with Alkermes (through
a subsidiary of Alkermes), pursuant to which Alkermes will (i) provide clinical and commercial bulk supplies of injectable
meloxicam formulation and (ii) provide development services with respect to the Chemistry, Manufacturing and Controls
section of an NDA for injectable meloxicam. Pursuant to the Supply Agreement, Alkermes will supply the Company with such
quantities of bulk injectable meloxicam formulation as shall be reasonably required for the completion of clinical trials of
injectable meloxicam. During the term of the Supply Agreement, the Company will purchase its clinical and commercial
supplies of bulk injectable meloxicam formulation exclusively from Alkermes, subject to certain exceptions, for a period of
time.
(c)
Litigation
The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its
business. Except as disclosed below, the Company is not currently a party to any such claims or proceedings that, if decided
adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or
results of operations.
On May 31, 2018, a securities class action lawsuit was filed against the Company and certain of its officers and directors in the
U.S. District Court for the Eastern District of Pennsylvania (Case No. 2:18-cv-02279-MMB) that purported to state a claim for
alleged violations of Section 10(b) and 20(a) of the Exchange Act and Rule 10(b)(5) promulgated thereunder, based on
statements made by the Company concerning the NDA for IV meloxicam. The complaint seeks unspecified damages, interest,
attorneys’ fees and other costs. On December 10, 2018, lead plaintiff filed an amended complaint that asserted the same claims
and sought the same relief but included new allegations and named additional officers and directors as defendants. On February
8, 2019, the Company filed a motion to dismiss the amended complaint in its entirety. The Company believes that the lawsuit is
without merit and intends to vigorously defend against it. The lawsuit is in the early stages and, at this time, no assessment can
be made as to its likely outcome or whether the outcome will be material to the Company.
(d)
Leases
The Company is a party to various operating leases in Malvern, Pennsylvania, Gainesville, Georgia and Dublin, Ireland for
office, manufacturing, and chemistry, manufacturing and controls development space. The Company is also a party to operating
leases for office equipment and storage. Rent expense includes rent as well as additional operating and tenant improvement
expenses.
As of December 31, 2018, future minimum lease payments excluding operating expenses and tenant improvements for the
leases, are as follows:
2019
2020
2021
2022
2023 and thereafter
Total
F-20
$
$
781
613
523
529
403
2,849
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(e)
Purchase Commitments
As of December 31, 2018, the Company had outstanding non-cancelable and cancelable purchase commitments of $26,763
related to inventory, capital expenditures and other goods and services, including pre-commercial/manufacturing scale-up and
clinical activities.
(f)
Certain Compensation and Employment Agreements
The Company has entered into employment agreements with certain of its named executive officers. As of December 31, 2018,
these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than
$461 from that date through calendar year 2019.
(14) Capital Structure
(a)
Common Stock
The Company is authorized to issue 50,000,000 shares of common stock, with a par value of $0.01 per share.
Reflected below are the Company’s capital raises since its initial public offering, or IPO:
On March 12, 2014, the Company completed an IPO, in which the Company sold 4,312,500 shares of common stock at $8.00
per share, resulting in gross proceeds of $34,500. In connection with the IPO, the Company paid $4,244 in underwriting
discounts, commissions and offering costs, resulting in net proceeds of $30,256. Also in connection with the IPO, all of the
outstanding shares of the Company’s Series A Redeemable Convertible Preferred Stock, including accreted dividends, and
Bridge Notes, including accrued interest, were converted into common stock.
On July 7, 2015, the Company closed a private placement with certain accredited investors in which the Company sold
1,379,311 shares of common stock at a price of $11.60 per share, for net proceeds of $14,812. The Company paid the placement
agents a fee equal to 6.0% of the aggregate gross proceeds from the private placement, plus reimbursement of certain expenses.
On August 19, 2016, the Company closed an underwritten public offering in which the Company sold 1,986,666 shares of
common stock at a price per share of $7.50, for net proceeds of $13,367 after deducting underwriting commissions and offering
expenses.
On December 16, 2016, the Company closed an underwritten public offering in which the Company sold 6,670,000 shares of
common stock at a price per share of $6.00, for net proceeds of $36,888 after deducting underwriting commissions and offering
expenses.
On December 29, 2017, the Company entered into a sales agreement, or the Sales Agreement, with Cowen and Company, LLC,
or Cowen, pursuant to which the Company may sell from time to time, at its option, shares of its common stock, $0.01 par value
per share, having an aggregate offering price of up to $40,000 through Cowen, as the placement agent. As of December 31,
2018, the Company did not have any sales of common stock under the Sales Agreement.
(b)
Common Stock Purchase Agreement
On February 2, 2015, the Company entered into a Common Stock Purchase Agreement, or the 2015 Purchase Agreement, with
Aspire Capital Fund, LLC, or Aspire Capital, pursuant to which Aspire Capital was committed to purchase, at the Company’s
election, up to an aggregate of $10,000 of shares of the Company’s common stock over the 24-month term of the 2015 Purchase
Agreement. On the execution of the 2015 Purchase Agreement, the Company issued 96,463 shares of common stock to Aspire
Capital with a fair value of $285, as consideration for entering in the 2015 Purchase Agreement. In addition, the Company
incurred $253 of costs in connection with the 2015 Purchase Agreement, which, along with the fair value of the common stock,
has been recorded as deferred equity costs. During 2016, the Company sold 1,143,940 shares of common stock under the 2015
Purchase Agreement for $7,796. The agreement expired in February 2017.
On March 2, 2018, the Company entered into a common stock purchase agreement, or the 2018 Purchase Agreement, with
Aspire Capital Fund, LLC, or Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations
set forth in the 2018 Purchase Agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an
aggregate of $20,000 of its shares of common stock over the approximately 30-month term of the 2018 Purchase Agreement. On
the execution of the 2018 Purchase Agreement, the Company agreed to issue 33,040 shares of common stock to Aspire Capital
with a fair value of $357 as consideration for entering into the 2018 Purchase Agreement.
F-21
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
As of December 31, 2018, the Company sold 1,950,000 shares of common stock under the 2018 Purchase Agreement for
proceeds of $16,999, at an average per share price of $8.72.
On February 19, 2019, the Company entered into a common stock purchase agreement, or the 2019 Purchase Agreement, with
Aspire Capital Fund, LLC, or Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations
set forth in the 2019 Purchase Agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an
aggregate of $20,000 of its shares of common stock over the approximately 30-month term of the Purchase Agreement. On the
execution of the 2019 Purchase Agreement, the Company agreed to issue 34,762 shares of common stock to Aspire Capital as
consideration for entering into the 2019 Purchase Agreement.
(c)
Preferred Stock
The Company is authorized to issue 10,000,000 shares of preferred stock, with a par value of $0.01 per share. As of
December 31, 2018, no preferred stock was issued or outstanding.
(d) Warrants
As of December 31, 2018, the Company had the following warrants outstanding to purchase shares of the Company’s common
stock:
Number of Shares
140,000
350,000
348,664
Exercise Price per Share
Expiration Date
$
$
$
12.00
8.26
6.84
March 2019
April 2022
November 2024
The warrants to purchase 140,000 and 348,664 shares related to Aegis Capital Corporation and Athyrium, respectively, are
equity classified. During the year ended December 31, 2017, the Company recorded Athyrium equity classified warrants of
$1,966, which is the fair value of $2,143 net of the related tax effect of $177. During the year ended December 31, 2018, the
Company revalued these warrants and increased the fair value by $89 due to the renegotiation and repricing of the warrants.
The warrant to purchase 350,000 shares related to Alkermes, is liability classified since it contains a contingent net cash
settlement feature. The fair value will be remeasured through settlement or expiration with changes in fair value recognized as a
period charge within the statement of operations.
The following table summarizes the fair value and the assumptions used for the Black-Scholes option-pricing model for the
liability classified warrants:
Fair value
Expected dividend yield
Expected volatility
Risk-free interest rates
Remaining contractual term
$
December 31, 2018
1,101
$
— %
69 %
2.49 %
December 31, 2017
3,406
— %
75 %
2.09 %
3.25 years
4.25 years
Each of the warrant agreements include usual and customary standard antidilution provisions and the Athyrium and Aegis
agreements contains additional antidilution provisions as well.
In April 2015, the Company issued a warrant to purchase 294,928 shares of common stock at an exercise price of $3.28 per
share to OrbiMed in connection with the Company’s prior credit agreement, which was liability classified. In April 2018, the
warrant was exercised on a cashless basis, with OrbiMed surrendering 80,213 shares, to cover the aggregate exercise price,
resulting in the issuance of 214,715 shares of common stock based on the closing bid price of the Company’s Common Stock on
April 27, 2018 of $12.06.
F-22
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(15) Comprehensive Loss
The Company’s comprehensive loss is shown on the Consolidated Statements of Operations and Comprehensive Loss as of
December 31, 2018, 2017 and 2016 and is comprised of net unrealized gains and losses on the Company’s available-for-sale securities.
The total comprehensive loss for the twelve months ended December 31, 2018, 2017 and 2016 was $79,722, $50,081 and $30,205,
respectively. There was no tax effect for the twelve months ended December 31, 2018, 2017 or 2016 of other comprehensive loss.
(16) Stock-Based Compensation
The Company established the 2008 Stock Option Plan, or the 2008 Plan, which allows for the granting of common stock awards, stock
appreciation rights, and incentive and nonqualified stock options to purchase shares of the Company’s common stock to designated
employees, non-employee directors, and consultants and advisors. As of December 31, 2018, no stock appreciation rights have been
issued. Subsequent to adoption, the 2008 Plan was amended to increase the authorized number of shares available for grant to 444,000
shares of common stock. This plan expired in 2018. In October 2013, the Company established the 2013 Equity Incentive Plan, or the
2013 Plan, which allows for the grant of stock options, stock appreciation rights and stock awards for a total of 600,000 shares of
common stock. In June 2015, the Company’s shareholders approved the Amended and Restated Equity Incentive Plan, or the A&R
Plan, which amended and restated the 2013 Plan and increased the aggregate amount of shares available for issuance to 2,000,000. On
December 1st of each year, pursuant to the “Evergreen” provision of the A&R Plan, the number of shares available under the plan may
be increased by the board of directors by an amount equal to 5% of the outstanding common stock on December 1st of that year. In
December 2018, 2017 and 2016, the number of shares available for issuance under the A&R Plan was increased by 1,082,972,
956,341, and 619,181, respectively. The total number of shares authorized for issuance under the A&R plan as of December 31, 2018
is 8,119,709.
Stock options are exercisable generally for a period of 10 years from the date of grant and generally vest over four years. As of
December 31, 2018, 3,777,352 shares are available for future grants under the 2013 Plan.
The weighted average grant-date fair value of the options awarded to employees during the years ended December 31, 2018, 2017 and
2016 was $5.95, $5.44 and 5.08, respectively. The fair value of the options was estimated on the date of grant using a Black-Scholes
option pricing model with the following assumptions:
Range of expected option life
Expected volatility
Risk-free interest rate
Expected dividend yield
2018
5.5 - 6 years
73.26% -
82.00%
December 31,
2017
6 years
75.10 -
84.71%
82.47%
2.32 - 3.03% 1.87 - 2.27% 1.07 - 2.09%
—
—
—
2016
6 years
The following table summarizes stock option activity during the years ended December 31, 2018 and 2017:
Balance, December 31, 2016
Granted
Exercised
Expired/forfeited/cancelled
Balance, December 31, 2017
Granted
Exercised
Expired/forfeited/cancelled
Balance, December 31, 2018
Vested
Vested and expected to vest
Number of
shares
2,611,929 $
1,105,170
(7,756 )
(114,468 )
3,594,875 $
949,861
(355,312 )
(414,359 )
3,775,065 $
2,259,870 $
3,775,065 $
Weighted
average
exercise
price
7.01
7.62
6.86
7.89
7.17
8.92
5.17
8.81
7.62
7.24
7.62
Weighted
average
remaining
contractual life
7.4 years
7.1 years
7.4 years
6.6 years
7.4 years
F-23
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Included in the table above are 980,000 options granted outside the plan. The grants were made pursuant to the NASDAQ inducement
grant exception in accordance with NASDAQ Listing Rule 5635(c)(4).
The following table summarizes restricted stock units activity during the years ended December 31, 2018 and 2017.
Balance, December 31, 2016
Granted
Vested and settled
Expired/forfeited/cancelled
Balance, December 31, 2017
Granted
Vested and settled
Expired/forfeited/cancelled
Balance, December 31, 2018
Expected to vest
Number of shares
7,750
369,043
(104,450 )
(1,750 )
270,593
1,011,487
(133,268 )
(45,416 )
1,103,396
870,622
Included in the table above are 47,000 time-based RSUs granted outside the plan. The grants were made pursuant to the NASDAQ
inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4).
In January 2018, the Company granted 242,396 time-based RSUs, which vest over four years. In March 2018, the Company granted
240,224 performance-based RSUs, which vesting is based on attaining 2018 financial, clinical and operational goals. In January 2019,
12,193 of the 2018 performance-based RSUs vested, which resulted in stock compensation expense of $136. The remaining 2018
performance-based RSUs were forfeited and cancelled due to failure to meet the 2018 performance goals.
In June 2018, the Company granted 444,418 time-based RSUs, which vest in two installments at nine and 18 months from the grant
date, as part of a key employee retention plan, excluding the Named Executive Officers.
Stock-based compensation expense for the twelve months ended December 31, 2018, 2017 and 2016 was $7,129, $5,546 and $3,889,
respectively.
As of December 31, 2018, there was $12,181 of unrecognized compensation expense related to unvested options and time-based RSUs
that are expected to vest and will be expensed over a weighted average period of 1.9 years. As of December 31, 2018, there was $2,588
of unrecognized compensation expense related to unvested performance-based RSUs that will be expensed if the performance criteria
are met.
The aggregate intrinsic value represents the total amount by which the fair value of the common stock subject to options exceeds the
exercise price of the related options. As of December 31, 2018, the aggregate intrinsic value of the vested and unvested options was
$2,189 and $191, respectively
In January 2019, the Company granted 1,184,655 options at a price of $7.99 per share, as well as 328,985 time-based restricted stock
units, which vest over four years, and 299,950 performance-based restricted stock units, which vesting is based on 2019 financial,
clinical, and operational goals. These grants are not included in the above tables.
(17) Segment Reporting
The Company operates through two business segments: an Acute Care segment and a revenue-generating CDMO segment. The Acute
Care segment is primarily focused on developing innovative products for hospital and related settings, and the CDMO segment
leverages the Company’s formulation expertise to develop and manufacture pharmaceutical products using the Company’s proprietary
delivery technologies for commercial partners who commercialize or plan to commercialize these products. Acute Care has no
revenue, and its costs consist primarily of expenses incurred in conducting the Company’s clinical and preclinical studies, acquiring
clinical trial materials, regulatory activities, personnel costs and pre-commercialization of meloxicam. CDMO revenue streams are
derived from manufacturing, royalty and profit-sharing revenues, as well as CDMO’s research and development services performed
for commercial partners.
F-24
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The accounting policies of the segments are the same as those described in the summary of significant accounting policies (see Note
3). The Company evaluates performance of its reportable segments based on revenue and operating loss. The Company does not
allocate interest income, interest expense or income taxes to its operating segments.
The following table summarizes segment information as of and for the years ended December 31, 2018, 2017 and 2016:
Revenues:
CDMO
Acute Care
Total
Operating income (loss):
CDMO
Acute Care
Total
Depreciation and amortization:
CDMO
Acute Care
Total
Capital expenditures:
CDMO
Acute Care
Total
Total goodwill:
CDMO
Acute Care
Total
Total assets:
CDMO
Acute Care
Total
$
$
$
$
$
$
$
$
For the Year ended December 31,
2017
2018
2016
77,347 $
—
77,347 $
71,834 $
—
71,834 $
69,337
—
69,337
24,940 $
(78,983 )
(54,043 ) $
25,409 $
(65,720 )
(40,311 ) $
24,232
(50,005 )
(25,773 )
7,572
4
7,576
3,735
35
3,770
7,455 $
395
7,850 $
7,376 $
71
7,447 $
7,154 $
3,372
10,526 $
5,405 $
767
6,172 $
December 31,
2018
December 31,
2017
$
$
$
$
4,319 $
2,127
6,446 $
4,319
2,127
6,446
87,879 $
67,614
155,493 $
78,136
108,090
186,226
(18) Revenue Recognition
Effective January 1, 2018, the Company adopted ASU 2014-09 using the modified retrospective method applied to contracts existing
as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under the new guidance while prior
period amounts are not adjusted and continue to be reported in accordance with previous guidance. See Note 3 for additional
information on the Company’s revenue recognition policies.
The Company uses the practical expedient to not account for significant financing components because the period between recognition
and collection does not exceed one year in any contract.
F-25
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Upon adoption, the Company recorded a decrease of $2,818 to the opening balance of accumulated deficit as of January 1, 2018. This
adjustment resulted from a change in revenue recognition associated with a variable portion of certain of its royalty revenue. Under
the new accounting standard, estimated royalty revenue to be received in the future that is deemed predominantly related to product
sales rather than the license for intellectual property, is included as a component of the product sale transaction consideration to the
extent such consideration is not probable of significant reversal. Prior to adoption of the new guidance, the Company recognized this
royalty revenue in the period the products were sold by the commercial partner.
The cumulative effect of the changes made to the Company’s consolidated January 1, 2018 balance sheet for the adoption of ASU
2014-09 were as follows:
Contract asset
Deferred income taxes
Total shareholders' equity
Balance at
December 31, 2017
$
— $
18,573
28,848
Adoption of
ASU 2014-09
3,755
$
(937 )
2,818
Balance at
January 1, 2018
3,755
17,636
31,666
The impact of the adoption of ASU 2014-09 on the Company’s condensed consolidated statement of operations and condensed
consolidated balance sheet was as follows:
Revenue
Net loss
Contract assets
Total assets
Accumulated deficit
Total shareholders' equity
(deficit)
Total liabilities and
shareholders' equity
Previous Revenue
Standard
Adoption of
ASU 2014-09
As Reported
Twelve Months Ended December 31, 2018
$
75,901 $
(81,169 )
1,446 $
1,446
77,347
(79,723 )
Previous Revenue
Standard
December 31, 2018
Adoption of
ASU 2014-09
As Reported
$
— $
150,292
5,201 $
5,201
5,201
155,493
(193,454 )
5,201
(188,253 )
(24,701 )
5,201
(19,500 )
150,292
5,201
155,493
As of December 31, 2018, as a result of the Company recording a full valuation allowance against its domestic deferred taxes during
2018, the impact to deferred income taxes related to the adoption of ASU 2014-09 was reversed.
Contract assets represent revenue recognized for performance obligations completed before an unconditional right to payment exists,
and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet
occurred. Contract assets were $5,201 and $3,755 at December 31, 2018 and January 1, 2018, respectively. Generally, the contract
assets balance is impacted by the recognition of additional contract assets, offset by amounts invoiced to customers or actual net
product sale amounts reported by the commercial partner for the period. For the twelve months ended December 31, 2018, actual net
product sale amounts reported by the Company’s commercial partner exceeded estimates of royalty amounts attributed to
manufactured product shipped as of January 1, 2018 for the related arrangements by approximately $817.
F-26
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
The following table presents changes in the Company’s contract assets for the twelve months ended December 31, 2018:
Contract asset, beginning of year
Change in estimate arising from
changes in transaction price
Reclassification of contract asset to
receivables, as the result of rights
to consideration becoming
unconditional
Contract assets recognized
Contract asset, end of period
$
$
3,755
817
(4,572 )
5,201
5,201
The following table disaggregates revenue by business segment and timing of revenue recognition:
CDMO
Acute Care
Revenue
Twelve Months Ended December 31, 2018
Point in time
Over time
Total
$
76,270 $
—
76,270
1,077 $
—
1,077
77,347
—
77,347
Adoption of ASU 2014-09 did not require capitalization of any costs to obtain or fulfill contracts. In general, the Company’s payment
terms for manufacturing revenue and research and development services is 30 days. Royalty revenue is recorded to accounts
receivable in the quarter that the product is sold by the commercial partner upon reporting from the commercial partner and payment
terms are generally 45 days after quarter end. Based on the adoption of ASU 2014-09, the timing difference between recognition of
certain royalty revenues as a contract asset and cash receipt is increased by an estimated 90 days.
(19)
Income Taxes
The components of loss before income tax are as follows:
Domestic
Foreign
Loss before income taxes
The components of income tax provision (benefit) are as follows:
Current:
Federal
State and local
Foreign
Deferred:
Federal
State and local
Foreign
Change in valuation allowance
F-27
2018
(32,126 ) $
(30,161 )
(62,287 ) $
December 31,
2017
(24,353 ) $
(27,607 )
(51,960 ) $
2016
1,207
(32,519 )
(31,312 )
2018
December 31,
2017
2016
(131 ) $
1
—
(130 )
(7,620 ) $
(3,654 )
(3,770 )
(15,044 )
32,610
17,436 $
(190 ) $
—
—
(190 )
(705 ) $
(985 )
3,450
1,760
(3,450 )
(1,880 ) $
298
18
—
316
(1,607 )
184
4,065
2,642
(4,065 )
(1,107 )
$
$
$
$
$
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows:
U.S. federal statutory income tax rate
Foreign tax rate differential
State taxes, net of federal benefit
Nondeductible expenses
Research and development credits
Change in federal tax rate
Change in valuation allowance
Other
Effective income tax rate
Year ended December 31,
2017
2018
2016
21.0 %
(4.1 )%
5.9 %
0.1 %
1.5 %
—
(52.4 )%
—
(28.0 )%
34.0 %
(11.4 )%
1.9 %
0.2 %
0.9 %
(15.2 )%
(6.6 )%
(0.2 )%
3.6 %
34.0 %
(22.3 )%
(0.1 )%
0.5 %
4.5 %
—
(13.1 )%
—
3.5 %
The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows:
Net operating loss carryforwards
Research and development credits
Capitalized start-up costs
Intangibles
Contingent consideration
Stock-based compensation
Interest expense
Other temporary differences
Gross deferred tax asset
Valuation allowance
Net deferred tax asset
Deferred tax liability
Net deferred taxes
December 31,
2018
2017
$
$
17,923 $
4,307
1,489
3,194
9,816
4,797
1,370
288
43,184
(40,417 )
2,767
(2,767 )
— $
10,704
3,389
1,431
2,236
6,588
2,873
—
430
27,651
(7,830 )
19,821
(1,248 )
18,573
In assessing the realizability of the net deferred tax asset, the Company considers all relevant positive and negative evidence in
determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The
realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior
to the expiration of the net operating loss carryforwards.
In 2018, the Company evaluated the need for a valuation allowance against its U.S. and state deferred tax assets based on the available
positive and negative evidence available. An important aspect of objective negative evidence evaluated was the Company’s historical
operating results over the prior three-year period. The Company is in a cumulative three year loss and during the quarter ended
December 31, 2018, the Company renegotiated the terms of its milestone payments to be received from Alkermes, and as such a net
income position is now not expected for 2019. This significantly renegotiated contract, coupled with the FDA’s declining to approve
meloxicam for commercialization earlier in 2018, created a greater level of negative evidence during the quarter ended December 31,
2018 as compared to prior periods. The objective evidence presented by the cumulative losses in recent years coupled with the recent
renegotiated contract is difficult to overcome and would require a substantial amount of objectively verifiable positive evidence of
future income to support the realizability of the Company’s U.S. and state deferred tax assets. While positive evidence exists by way
of the Company’s plan to continue its efforts to commercialize meloxicam, management concluded that the negative evidence now
outweighs the positive evidence. Thus, it is more likely than not that the Company’s U.S. and state deferred tax assets will not be
realized and a full valuation allowance was recognized against the Company’s U.S. and state deferred tax assets during the three
months ended December 31, 2018.
F-28
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
Additionally, the Company believes that it is more likely than not that the Company’s deferred income tax asset associated with its
foreign net operating losses will not be realized in the immediate future. As such, there is a full valuation allowance against the net
deferred tax assets associated with foreign operations as of December 31, 2018 and 2017.
The following table summarizes carryforwards of Federal net operating losses and tax credits as of December 31, 2018:
Federal net operating losses - 2008 to 2017
Federal net operating losses - 2018
State net operating losses
Foreign net operating losses
Federal and state research and development credits
$
Amount
Expiration
8,200 2028 – 2038
13,058 No expiration
24,141 2028 – 2038
92,808 No expiration
4,307 2028 – 2038
Under the Tax Reform Act of 1986, as amended (the “Act”), the utilization of a corporation’s net operating loss and research and
development tax credit carryforwards is limited following a greater than 50% change in ownership during a three-year period. Any
unused annual limitation may be carried forward to future years for the balance of the carryforward period. The Company has done an
analysis to determine whether or not ownership changes, as defined by the Act, have occurred since inception. The Company
determined that it experienced ownership changes, as defined by the Act, during the 2008, 2014 and 2016 tax years as a result of past
financings; accordingly, the Company’s ability to utilize the aforementioned carryforwards will be limited. In addition, state net
operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 30%, 35% or 40% of taxable
income after modifications and apportionment on state net operating losses utilized in any one year during tax years beginning during
2017, 2018 or 2019 going forward, respectively.
The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2018,
the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the
Company’s statements of operations. Due to net operating loss and tax credit carry forwards that remain unutilized, income tax returns
for tax years from inception through 2016 remain subject to examination by the taxing jurisdictions.
On December 22, 2017, the Tax Cuts and Jobs Act (H.R. 1) (the “Tax Act”) was signed into law. The Tax Act contains significant
changes to corporate taxation, including (i) the reduction of the corporate income tax rate to 21%, (ii) the acceleration of expensing for
certain business assets, (iii) the one-time transition tax related to the transition of U.S. international tax from a worldwide tax system to
a territorial tax system, (iv) additional limitations on the deductibility of interest expense, and (v) expanded limitations on executive
compensation. The most significant impacts on the Company are as follows:
•
•
•
•
The Company remeasured its existing U.S. federal deferred tax assets and liabilities at the rate that the Company
expects to be in effect when those deferred taxes will be realized, which is now 21%. In 2017, the Company recognized
a one-time net expense from the deferred tax remeasurement of approximately $7,900.
A one-time tax is due on certain accumulated foreign earnings (Deemed Repatriation Tax), which is payable over eight
years. The tax rate is generally 15.5% on the portion of the earnings held in cash and cash equivalents and 8% on the
remainder. As the Company has an accumulated foreign deficit for its operations in Ireland, we are not currently
subject to this Deemed Repatriation Tax.
The Company will be able to claim an immediate deduction for investments in qualified fixed assets acquired and
placed in service beginning September 27, 2017 through 2022. This provision phases out through 2026.
Given our taxable losses in the U.S., we will be limited in our ability to deduct interest expense, and any disallowed
interest expense for 2018 and tax years following will result in an indefinite carry forward until such time as we meet
the taxable income thresholds required to deduct interest expense.
Pursuant to the Securities and Exchange Commission Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the
Tax Act ("SAB 118"), the SEC gave issuers a one year measurement period to finalize accounting adjustments related to the act. For
the year-ended December 31, 2017, the Company disclosed it was unable to determine a reasonable estimate of the decrease to its
stock compensation deferred tax asset, if any, under the Tax Act due to expanded limitations on the deductibility of executive
compensation. The Company has subsequently determined there were no material changes required related to any provisional
amounts recorded and the measurement period under SAB 118 has closed.
F-29
RECRO PHARMA, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
(amounts in thousands, except share and per share data)
(20) Related Party Transactions
The Company’s President and Chief Executive Officer, or CEO, owns a majority of the stock of Malvern Consulting Group, or MCG,
a pharmaceutical incubator and consulting firm. The CEO’s husband, who is also a shareholder of the Company, is a consultant and a
shareholder of MCG. In addition, the CEO’s son is the President and a shareholder of MCG. During 2016, certain immediate family
members of the CEO were employees of MCG, including the CEO’s brother and sister-in-law. Since formation, the Company entered
into various transactions with MCG, as detailed below. However, since becoming a public company, the Company sought to decrease
its involvement with MCG, and, as of December 31, 2016, the Company no longer has any involvement or transactions with MCG.
During 2016, certain of the Company’s executive officers, its CEO, its Senior Vice President, Development and its Senior Vice
President, Regulatory Affairs and Quality Assurance, who is also the CEO's sister, provided minimal consulting services from time to
time to MCG. Until December 31, 2016, the Company was a party to a Master Consulting Services Agreement with MCG. Pursuant to
the agreement, MCG provided the Company with certain consulting services for a fee based upon hourly rates previously approved by
the Company’s Board of Directors. In consideration for such services, the Company recorded $363 of expenses for the twelve months
ended December 31, 2016. A portion of these amounts were used during 2016 to pay a portion of the respective salaries of MCG
employees that, as described above, included immediate family members of the Company’s CEO.
Until December 31, 2016, the Company was party to an Office Services Agreement with MCG for the lease of an aggregate of 8,458
square feet of office and lab space located at its Malvern, Pennsylvania facility and the provision of IT services and general office
support. Pursuant to the Office Services Agreement, the Company paid MCG $206 in the twelve months ended 2016. The Company
terminated this agreement on December 31, 2016 and is now a party to a six-year lease directly with the landlord of the Company’s
Malvern, Pennsylvania facility (see Note 13).
As of December 31, 2016, the Company terminated the Master Consulting Agreement and the Office Services Agreement and MCG
no longer provides any services or has any contracts with the Company.
The Company’s Senior Vice President, Regulatory and Quality, who is the CEO’s sister, has held that position since 2014. Effective
January 1, 2017, the CEO’s sister-in-law and brother, respectively, terminated their employment with MCG and were hired as the
Company’s Director of Human Resources and the Company’s Vice President, Manufacturing. The Company’s Board of Directors
approved these hires consistent with the Company’s related person transaction policy
A Non-Executive Director of the Company’s Irish subsidiary is a Managing Director and a majority shareholder of HiTech Health Ltd,
or HiTech Health, a consultancy firm for the biotech, pharmaceutical and medical device industry. Since 2016, HiTech Health has
provided the Company with certain consulting services and in November 2017 both parties entered into a Service Agreement to
engage in both regulatory and supply chain project support and consultancy. In consideration for such services, the Company recorded
$309 and $151 of expenses for the twelve months ended December 31, 2018 and 2017, respectively. A portion of the amount relates to
consultancy services provided by the Non-Executive Director.
(21) Retirement Plan
The Company has a voluntary 401(k) Savings Plan (the 401(k) Plan) in which all employees are eligible to participate. The Company’s
policy is to match 100% of the employee contributions up to a maximum of 5% of employee compensation. Total Company
contributions to the 401(k) plan for the year ended December 31, 2018, 2017 and 2016 were $1,338, $1,160 and $711, respectively.
F-30
REGISTRATION RIGHTS AGREEMENT
Exhibit 4.8
REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of February 19, 2019, by and between
RECRO PHARMA, INC., a Pennsylvania corporation (the “Company”), and ASPIRE CAPITAL FUND, LLC, an Illinois
limited liability company (together with its permitted assigns, the “Buyer”). Capitalized terms used herein and not otherwise
defined herein shall have the respective meanings set forth in the Common Stock Purchase Agreement by and between the parties
hereto, dated as of the date hereof (as amended, restated, supplemented or otherwise modified from time to time, the “Purchase
Agreement”).
WHEREAS:
A.
Upon the terms and subject to the conditions of the Purchase Agreement, (i) the Company has agreed to issue to
the Buyer, and the Buyer has agreed to purchase, up to Twenty Million Dollars ($20,000,000) of the Company’s common stock, par
value $0.01 per share (the “Common Stock”), pursuant to Section 1 of the Purchase Agreement (such shares, the “Purchase
Shares”), and (ii) the Company has agreed to issue to the Buyer such number of shares of Common Stock as is required pursuant to
Section 4(e) of the Purchase Agreement (the “Commitment Shares”); and
B.
To induce the Buyer to enter into the Purchase Agreement, the Company has agreed to provide certain
registration rights under the Securities Act of 1933, as amended, and the rules and regulations thereunder, or any similar successor
statute (collectively, the “1933 Act”), and applicable state securities laws.
NOW, THEREFORE, in consideration of the promises and the mutual covenants contained herein and other good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Buyer hereby agree as
follows:
1.
DEFINITIONS.
As used in this Agreement, the following terms shall have the following meanings:
“Person” means any person or entity including any corporation, a limited liability company, an
association, a partnership, an organization, a business, an individual, a governmental or political subdivision thereof or a
governmental agency.
a.
b.
“Prospectus” means the base prospectus, including all documents incorporated therein by reference,
included in any Registration Statement (as hereinafter defined), as it may be supplemented by a prospectus or prospectus
supplement (including the Prospectus Supplement (as hereinafter defined)), in the form in which such prospectus and/or Prospectus
Supplement have most recently been filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”)
pursuant to Rule 424(b) under the 1933 Act, together with any then issued “issuer free writing prospectus(es),” as defined in Rule
433 of the 1933 Act, relating to the Registrable Securities.
c.
“Register,” “registered,” and “registration” refer to a registration effected by preparing and filing
one or more registration statements of the Company in compliance with the 1933 Act and pursuant to Rule 415 under the 1933 Act
or any successor rule providing for offering securities on a continuous basis (“Rule 415”), and the declaration or ordering of
effectiveness of such registration statement(s) by the SEC.
d.
“Registrable Securities” means the Purchase Shares that may from time to time be issued or issuable
to the Buyer upon purchases of the Available Amount under the Purchase Agreement (without regard to any limitation or restriction
on purchases), the Commitment Shares issued or issuable to the Buyer, and any shares of capital stock issued or issuable with
respect to the Purchase Shares, the Commitment Shares or the Purchase Agreement as a result of any stock split, stock dividend,
recapitalization, exchange or similar event, without regard to any limitation on purchases under the Purchase Agreement.
e.
“Registration Statement” means the Shelf Registration Statement and any other registration
statement of the Company, as amended when it became effective, including all documents filed as part thereof or incorporated by
reference therein, and including any information contained in a Prospectus subsequently filed with the SEC pursuant to Rule 424(b)
under the 1933 Act or deemed to be a part of such registration statement pursuant to Rule 430B or 462(b) of the 1933 Act, covering
the sale of the Registrable Securities.
f.
(File No. 333-218487).
“Shelf Registration Statement” means the Company’s existing registration statement on Form S-3
2.
REGISTRATION.
a.
Mandatory Registration. The Company shall within two (2) Business Days from the Commencement
Date file with the SEC a prospectus supplement to the prospectus dated June 12, 2017 forming a part of the Shelf Registration
Statement specifically relating to the Registrable Securities (the “Prospectus Supplement”). The Buyer and its counsel shall have
had a reasonable opportunity to review and comment upon such Prospectus Supplement prior to its filing with the SEC. The Buyer
shall furnish all information reasonably requested by the Company for inclusion therein. The Company shall use its commercially
reasonable efforts to keep the Shelf Registration Statement effective pursuant to Rule 415 promulgated under the 1933 Act and
available for sales of all of the Registrable Securities at all times until the earlier of (i) the Company no longer qualifies to make sales
under the Shelf Registration Statement (which shall be understood to include the inability of the Company to immediately register
sales of Registrable Securities to the Buyer under the Shelf Registration Statement or any New Registration Statement (as defined
below) pursuant to General Instruction I.B.6 of Form S-3), (ii) the date on which the Company shall have sold all the Registrable
Securities and no Available Amount remains under the Purchase Agreement, or (iii) the date on which the Purchase Agreement is
terminated (the “Registration Period”). The Shelf Registration Statement (including any amendments or supplements thereto and
prospectuses contained therein) shall not contain any untrue statement of a material fact or omit to state a material fact required to
be stated therein, or necessary to make the statements therein, in light of the circumstances under which they were made, not
misleading.
b.
Rule 424 Prospectus. The Company shall, as required by applicable securities regulations, from time to time
file with the SEC, pursuant to Rule 424 promulgated under the 1933 Act, a prospectus, including any amendments or prospectus
supplements thereto, to be used in connection with sales of the Registrable Securities under the Registration Statement. The Buyer
and its counsel shall have two (2) Business Days to review and comment upon such prospectus prior to its filing with the SEC. The
Buyer shall use its commercially reasonable efforts to comment upon such prospectus within two (2) Business Days from the date
the Buyer receives the final version of such prospectus.
c.
Sufficient Number of Shares Registered. In the event the number of shares available under the Shelf
Registration Statement is insufficient to cover the Registrable Securities, the Company shall, to the extent necessary and permissible,
amend the Shelf Registration Statement or file a new registration statement (a “New Registration Statement”), so as to cover all of
such Registrable
Securities as soon as reasonably practicable, but in any event not later than ten (10) Business Days after the necessity therefor
arises. The Company shall use its reasonable best efforts to have such amendment and/or New Registration Statement become
effective as soon as reasonably practicable following the filing thereof.
3.
RELATED OBLIGATIONS.
With respect to the Registration Statement and whenever any Registrable Securities are to be registered pursuant to
Sections 2(a) and (c), including on the Shelf Registration Statement or on any New Registration Statement, the Company shall use
its commercially reasonable efforts to effect the registration of the Registrable Securities in accordance with the intended method of
disposition thereof and, pursuant thereto, the Company shall have the following obligations:
a.
The Company shall prepare and file with the SEC such amendments (including post-effective
amendments) and supplements to any Registration Statement and any New Registration Statement and any Prospectus used in
connection with such Registration Statement, as may be necessary to keep the Registration Statement or any New Registration
Statement effective at all times during the Registration Period, subject to Permitted Delays and Section 3(e) hereof and, during such
period, comply with the provisions of the 1933 Act with respect to the disposition of all Registrable Securities of the Company
covered by the Registration Statement or any New Registration Statement until such time as all of such Registrable Securities shall
have been disposed of in accordance with the intended methods of disposition by the seller or sellers thereof as set forth in such
Registration Statement. Should the Company file a post-effective amendment to the Registration Statement or a New Registration
Statement, the Company will use its commercially reasonable efforts to have such filing declared effective by the SEC within thirty
(30) consecutive Business Days following the date of filing, which such period shall be extended for an additional thirty (30)
Business Days if the Company receives a comment letter from the SEC in connection therewith. If (i) there is material non-public
information regarding the Company which the Company’s Board of Directors reasonably determines not to be in the Company’s
best interest to disclose and which the Company is not otherwise required to disclose or (ii) there is a significant business
opportunity (including, but not limited to, the acquisition or disposition of assets (other than in the ordinary course of business) or
any merger, consolidation, tender offer or other similar transaction) available to the Company which the Company’s Board of
Directors reasonably determines not to be in the Company’s best interest to disclose and which the Company would be required to
disclose under a Registration Statement or a New Registration Statement, then the Company may postpone or suspend filing or
effectiveness of such Registration Statement or New Registration Statement or use of the prospectus under the Registration
Statement or New Registration Statement for a period not to exceed thirty (30) consecutive days, provided that the Company may
not postpone or suspend its obligation under this Section 3(a) for more than sixty (60) days in the aggregate during any twelve (12)
month period (each, a “Permitted Delay”).
b.
The Company shall submit to the Buyer for review and comment any disclosure in the Registration
Statement, and all amendments and supplements thereto (other than prospectus supplements that consist only of a copy of a filed
Form 10-K, Form 10-Q or Current Report on Form 8-K or any amendment as a result of the Company’s filing of a document that is
incorporated by reference into the Registration Statement), containing information provided by the Buyer for inclusion in such
document and any descriptions or disclosure regarding the Buyer, the Purchase Agreement, including the transaction contemplated
thereby, or this Agreement at least two (2) Business Days prior to their filing with the SEC, and not file any document in a form to
which Buyer reasonably and timely objects. Upon request of the Buyer, the Company shall provide to the Buyer all disclosure in
the Registration Statement and all amendments and supplements thereto (other than prospectus supplements that consist only of a
copy of a filed Form 10‑K, Form 10-Q or Current Report on Form 8-K or any amendment as a result of the Company’s filing of a
document that is incorporated by reference into a Registration Statement) at least two (2) Business Days prior to their filing with the
SEC, and not file any document in a form to which Buyer reasonably and
timely objects. The Buyer shall use its reasonable best efforts to comment upon the Registration Statement or any New Registration
Statement and any amendments or supplements thereto within two (2) Business Days from the date the Buyer receives the final
version thereof. The Company shall furnish to the Buyer, without charge, any correspondence from the SEC or the staff of the SEC
to the Company or its representatives relating to the Registration Statement or any New Registration Statement.
c.
Upon request of the Buyer, the Company shall furnish to the Buyer, (i) promptly after the same is prepared
and filed with the SEC, at least one copy of the Registration Statement and any amendment(s) thereto, including all financial
statements and schedules, all documents incorporated therein by reference and all exhibits, (ii) upon the effectiveness of any
amendment(s) to a Registration Statement, a copy of the prospectus included in such Registration Statement and all amendments and
supplements thereto (or such other number of copies as the Buyer may reasonably request) and (iii) such other documents, including
copies of any preliminary or final prospectus, as the Buyer may reasonably request from time to time in order to facilitate the
disposition of the Registrable Securities owned by the Buyer.
d.
The Company shall use commercially reasonable efforts to (i) register and qualify, unless an
exemption from registration and qualification is available, the Registrable Securities covered by a Registration Statement under such
other securities or “blue sky” laws of such jurisdictions in the United States as the Buyer reasonably requests, (ii) subject to
Permitted Delays, prepare and file in those jurisdictions, such amendments (including post-effective amendments) and supplements
to such registrations and qualifications as may be necessary to maintain the effectiveness thereof during the Registration Period, (iii)
take such other actions as may be necessary to maintain such registrations and qualifications in effect at all times during the
Registration Period, and (iv) take all other actions reasonably necessary or advisable to qualify the Registrable Securities for sale in
such jurisdictions; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (x)
qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(d), (y) subject
itself to general taxation in any such jurisdiction, or (z) file a general consent to service of process in any such jurisdiction. The
Company shall promptly notify the Buyer who holds Registrable Securities of the receipt by the Company of any notification with
respect to the suspension of the registration or qualification of any of the Registrable Securities for sale under the securities or “blue
sky” laws of any jurisdiction in the United States or its receipt of actual notice of the initiation or threat of any proceeding for such
purpose.
e.
Subject to Permitted Delays, as promptly as reasonably practicable after becoming aware of such
event or facts, the Company shall notify the Buyer in writing if the Company has determined that the Prospectus included in any
Registration Statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to
be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not
misleading, and as promptly as reasonably practical (taking into account the Company’s good faith assessment of any adverse
consequences to the Company and its shareholders of premature disclosure of such event or facts) prepare a prospectus supplement
or amendment to such Registration Statement to correct such untrue statement or omission, and, upon the Buyer’s request, deliver a
copy of such prospectus supplement or amendment to the Buyer. In providing this notice to the Buyer, the Company shall not
include any other information about the facts underlying the Company’s determination and shall not in any way communicate any
material nonpublic information about the Company or the Common Stock to the Buyer. The Company shall also promptly notify
the Buyer in writing (i) when a prospectus or any prospectus supplement or post-effective amendment has been filed, and when a
Registration Statement or any post-effective amendment has become effective (notification of such effectiveness shall be delivered
to the Buyer by facsimile or e-mail on the same day of such effectiveness), (ii) of any request by the SEC for amendments or
supplements to any Registration Statement or related prospectus or related information, and (iii) of the Company’s reasonable
determination that a post-effective amendment to a Registration Statement would be appropriate. In no
event shall the delivery of a notice under this Section 3(e), or the resulting unavailability of a Registration Statement, without regard
to its duration, for disposition of securities by Buyer be considered a breach by the Company of its obligations under this
Agreement. The preceding sentence in this Section 3(e) does not limit whether an event of default has occurred as set forth in
Section 9(a) of the Purchase Agreement.
f.
The Company shall use its commercially reasonable efforts to prevent the issuance of any stop order
or other suspension of effectiveness of any Registration Statement, or the suspension of the qualification of any Registrable
Securities for sale in any jurisdiction and, if such an order or suspension is issued, to obtain the withdrawal of such order or
suspension at the earliest practical time and to notify the Buyer of the issuance of such order and the resolution thereof or its receipt
of actual notice of the initiation or threat of any proceeding for such purpose.
g.
The Company shall (i) cause all the Registrable Securities to be listed on each securities exchange on
which securities of the same class or series issued by the Company are then listed, if any, if the listing of such Registrable Securities
is then permitted under the rules of such exchange, or (ii) secure designation and quotation of all the Registrable Securities if the
Principal Market (as such term is defined in the Purchase Agreement) is an automated quotation system. The Company shall pay all
fees and expenses in connection with satisfying its obligation under this Section.
h.
The Company shall cooperate with the Buyer to facilitate the timely preparation and delivery of
certificates (not bearing any restrictive legend) representing the Registrable Securities to be offered pursuant to any Registration
Statement and enable such certificates to be in such denominations or amounts as the Buyer may reasonably request and registered
in such names as the Buyer may request.
Stock.
i.
j.
The Company shall at all times provide a transfer agent and registrar with respect to its Common
If reasonably requested by the Buyer, the Company shall (i) promptly incorporate in a prospectus supplement
or post-effective amendment to the Registration Statement such information as the Buyer believes should be included therein
relating to the sale and distribution of Registrable Securities, including, without limitation, information with respect to the number of
Registrable Securities being sold, the purchase price being paid therefor and any other terms of the offering of the Registrable
Securities; (ii) make all required filings of such prospectus supplement or post-effective amendment as promptly as practicable once
notified of the matters to be incorporated in such prospectus supplement or post-effective amendment; and (iii) supplement or make
amendments to any Registration Statement (including by means of any document incorporated therein by reference).
k.
The Company shall use its commercially reasonable efforts to cause the Registrable Securities covered by any
Registration Statement to be registered with or approved by such other governmental agencies or authorities in the United States as
may be necessary to consummate the disposition of such Registrable Securities.
l.
If reasonably requested by the Buyer at any time, the Company shall deliver to the Buyer a written
confirmation of whether or not the effectiveness of such Registration Statement has lapsed at any time for any reason (including,
without limitation, the issuance of a stop order) and whether or not the Registration Statement is currently effective and available to
the Company for sale of all of the Registrable Securities.
to expedite and facilitate disposition by the Buyer of Registrable Securities pursuant to any Registration Statement.
m.
The Company agrees to take all other reasonable actions as necessary and reasonably requested by the Buyer
4.
OBLIGATIONS OF THE BUYER.
a.
The Buyer has furnished to the Company in Exhibit A hereto such information regarding itself, the
Registrable Securities held by it and the intended method of disposition of the Registrable Securities held by it as required to effect
the registration of such Registrable Securities and shall execute such documents in connection with such registration as the Company
may reasonably request. The Company shall notify the Buyer in writing of any other information the Company reasonably requires
from the Buyer in connection with any Registration Statement hereunder. The Buyer will as promptly as practicable notify the
Company of any material change in the information set forth in Exhibit A, other than changes in its ownership of the Common
Stock.
connection with the preparation and filing of any amendments and supplements to any Registration Statement hereunder.
b.
The Buyer agrees to cooperate with the Company as reasonably requested by the Company in
5.
EXPENSES OF REGISTRATION.
All reasonable expenses of the Company, other than sales or brokerage commissions and fees and
disbursements of counsel for the Buyer, incurred in connection with registrations, filings or qualifications pursuant to Sections 2 and
3, including, without limitation, all registration, listing and qualifications fees, printers and accounting fees, and fees and
disbursements of counsel for the Company, shall be paid by the Company.
6.
INDEMNIFICATION.
a.
To the fullest extent permitted by law, the Company will, and hereby does, indemnify, hold harmless and
defend the Buyer, each Person, if any, who controls the Buyer, the members, the directors, officers, partners, employees, agents,
representatives of the Buyer and each Person, if any, who controls the Buyer within the meaning of the 1933 Act or the Securities
Exchange Act of 1934, as amended (the “1934 Act”) (each, an “Indemnified Person”), against any third party losses, claims,
damages, liabilities, judgments, fines, penalties, charges, costs, reasonable attorneys’ fees, amounts paid in settlement (with the
prior consent of the Company, such consent not to be unreasonably withheld) or reasonable expenses, (collectively, “Claims”)
reasonably incurred in investigating, preparing or defending any action, claim, suit, inquiry, proceeding, investigation or appeal
taken from the foregoing by or before any court or governmental, administrative or other regulatory agency or body or the SEC,
whether pending or threatened, whether or not an indemnified party is or may be a party thereto (“Indemnified Damages”), to which
any of them may become subject insofar as such Claims (or actions or proceedings, whether commenced or threatened, in respect
thereof) arise out of or are based upon: (i) any untrue statement or alleged untrue statement of a material fact in the Registration
Statement, any New Registration Statement or any post-effective amendment thereto or in any filing made in connection with the
qualification of the offering under the securities or other “blue sky” laws of any jurisdiction in which Registrable Securities are
offered (“Blue Sky Filing”), or the omission or alleged omission to state a material fact required to be stated therein or necessary to
make the statements therein not misleading, (ii) any untrue statement or alleged untrue statement of a material fact contained in the
final Prospectus or the omission or alleged omission to state therein any material fact necessary to make the statements made
therein, in light of the circumstances under which the statements therein were made, not misleading, or (iii) any violation or alleged
violation by the Company of the 1933 Act, the 1934 Act, any other law, including, without limitation, any state securities law, or any
rule or regulation thereunder relating to the offer or sale of the Registrable Securities pursuant to the Registration Statement or any
New Registration Statement (the matters in the foregoing clauses (i) through (iii) being, collectively, “Violations”). The Company
shall reimburse each Indemnified Person
promptly as such expenses are incurred and are due and payable, for any reasonable legal fees or other reasonable expenses incurred
by them in connection with investigating or defending any such Claim. Notwithstanding anything to the contrary contained herein,
the indemnification agreement contained in this Section 6(a): (A) shall not apply to a Claim by an Indemnified Person arising out of
or based upon a Violation which occurs in reliance upon and in conformity with information furnished in writing to the Company by
the Buyer or such Indemnified Person expressly for use in connection with the preparation of the Registration Statement, any New
Registration Statement, the Prospectus or any such amendment thereof or supplement thereto, if such prospectus was timely made
available by the Company; (B) with respect to any superseded prospectus, shall not inure to the benefit of any such person from
whom the person asserting any such Claim purchased the Registrable Securities that are the subject thereof (or to the benefit of any
other Indemnified Person) if the untrue statement or omission of material fact contained in the superseded prospectus was corrected
in the revised prospectus, as then amended or supplemented, if such revised prospectus was timely made available by the Company
pursuant to Section 3(c) or Section 3(e), and the Indemnified Person was promptly advised in writing not to use the incorrect
prospectus prior to the use giving rise to a violation; (C) shall not be available to the extent such Claim is based on a failure of the
Buyer to deliver, or to cause to be delivered, the prospectus made available by the Company, if such prospectus was theretofore
made available by the Company pursuant to Section 3(c) or Section 3(e); and (D) shall not apply to amounts paid in settlement of
any Claim if such settlement is effected without the prior written consent of the Company, which consent shall not be unreasonably
withheld. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of the
Indemnified Person and shall survive the transfer of the Registrable Securities by the Buyer pursuant to Section 8.
b.
In connection with the Registration Statement any New Registration Statement or Prospectus, the Buyer
agrees to indemnify, hold harmless and defend, to the same extent and in the same manner as is set forth in Section 6(a), the
Company, each of its directors, each of its officers who signed the Registration Statement or signs any New Registration Statement,
each Person, if any, who controls the Company within the meaning of the 1933 Act or the 1934 Act (collectively and together with
an Indemnified Person, an “Indemnified Party”), against any Claim or Indemnified Damages to which any of them may become
subject, under the 1933 Act, the 1934 Act or otherwise, insofar as such Claim or Indemnified Damages arise out of or are based
upon any Violation, in each case to the extent, and only to the extent, that such Violation occurs in reliance upon and in conformity
with written information about the Buyer set forth on Exhibit A attached hereto or updated from time to time in writing by the Buyer
and furnished to the Company by the Buyer expressly for inclusion in the Shelf Registration Statement or Prospectus or any New
Registration Statement or from the failure of the Buyer to deliver or to cause to be delivered the prospectus made available by the
Company, if such prospectus was timely made available by the Company pursuant to Section 3(c) or Section 3(e); and, subject to
Section 6(d), the Buyer will reimburse any legal or other expenses reasonably incurred by them in connection with investigating or
defending any such Claim; provided, however, that the indemnity agreement contained in this Section 6(b) and the agreement with
respect to contribution contained in Section 7 shall not apply to amounts paid in settlement of any Claim if such settlement is
effected without the prior written consent of the Buyer, which consent shall not be unreasonably withheld. Such indemnity shall
remain in full force and effect and shall survive the transfer of the Registrable Securities by the Buyer pursuant to Section 8.
c.
Promptly after receipt by an Indemnified Person or Indemnified Party under this Section 6 of notice
of the commencement of any action or proceeding (including any governmental action or proceeding) involving a Claim, such
Indemnified Person or Indemnified Party shall, if a Claim in respect thereof is to be made against any indemnifying party under this
Section 6, deliver to the indemnifying party a written notice of the commencement thereof, and the indemnifying party shall have
the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly
noticed, to assume control of the defense thereof with counsel mutually satisfactory to the indemnifying party and the Indemnified
Person or the Indemnified Party, as the case may be, and upon such notice, the
indemnifying party shall not be liable to the Indemnified Person or Indemnified Party for any legal or other expenses subsequently
incurred by the Indemnified Person or Indemnified Party in connection with the defense thereof; provided, however, that an
Indemnified Person or Indemnified Party (together with all other Indemnified Persons and Indemnified Parties that may be
represented without conflict by one counsel) shall have the right to retain its own counsel with the fees and expenses to be paid by
the indemnifying party, if, in the reasonable opinion of counsel retained by the indemnifying party, the representation by such
counsel of the Indemnified Person or Indemnified Party and the indemnifying party would be inappropriate due to actual or
potential differing interests between such Indemnified Person or Indemnified Party and any other party represented by such counsel
in such proceeding. The Indemnified Party or Indemnified Person shall cooperate with the indemnifying party in connection with
any negotiation or defense of any such action or claim by the indemnifying party and shall furnish to the indemnifying party all
information reasonably available to the Indemnified Party or Indemnified Person which relates to such action or claim. The
indemnifying party shall keep the Indemnified Party or Indemnified Person fully apprised as to the status of the defense or any
settlement negotiations with respect thereto. No indemnifying party shall be liable for any settlement of any action, claim or
proceeding effected without its written consent, provided, however, that the indemnifying party shall not unreasonably withhold,
delay or condition its consent. No indemnifying party shall, without the consent of the Indemnified Party or Indemnified Person,
consent to entry of any judgment or enter into any settlement or other compromise which does not include as an unconditional term
thereof the giving by the claimant or plaintiff to such Indemnified Party or Indemnified Person of a release from all liability in
respect to such claim or litigation. Following indemnification as provided for hereunder, the indemnifying party shall be subrogated
to all rights of the Indemnified Party or Indemnified Person with respect to all third parties, firms or corporations relating to the
matter for which indemnification has been made. The failure to deliver written notice to the indemnifying party within a reasonable
time of the commencement of any such action shall not relieve such indemnifying party of any liability to the Indemnified Person or
Indemnified Party under this Section 6, except to the extent that the indemnifying party is prejudiced in its ability to defend such
action.
d.
The indemnification required by this Section 6 shall be made by periodic payments of the amount
thereof during the course of the investigation or defense, as and when bills are received or Indemnified Damages are incurred. Any
person receiving a payment pursuant to this Section 6 which person is later determined to not be entitled to such payment shall
return such payment (including reimbursement of expenses) to the person making it.
The indemnity agreements contained herein shall be in addition to (i) any cause of action or similar
right of the Indemnified Party or Indemnified Person against the indemnifying party or others, and (ii) any liabilities the
indemnifying party may be subject to pursuant to the law.
e.
7.
CONTRIBUTION.
To the extent any indemnification by an indemnifying party is prohibited or limited by law, the indemnifying
party agrees to make the maximum contribution with respect to any amounts for which it would otherwise be liable under Section 6
to the fullest extent permitted by law; provided, however, that: (i) no seller of Registrable Securities guilty of fraudulent
misrepresentation (within the meaning of Section 11(f) of the 1933 Act) shall be entitled to contribution from any party who was not
guilty of fraudulent misrepresentation; and (ii) contribution by any seller of Registrable Securities shall be limited in amount to the
net amount of proceeds received by such seller from the sale of such Registrable Securities.
8.
ASSIGNMENT OF REGISTRATION RIGHTS.
The Company shall not assign this Agreement or any rights or obligations hereunder without the prior written
consent of the Buyer; provided, however, that any transaction, whether by merger, reorganization, restructuring, consolidation,
financing or otherwise, whereby the Company remains the surviving entity immediately after such transaction shall not be deemed
an assignment. The Buyer may not assign its rights under this Agreement without the prior written consent of the Company.
9.
AMENDMENT OF REGISTRATION RIGHTS.
in a particular instance and either retroactively or prospectively) only with the written consent of the Company and the Buyer.
Provisions of this Agreement may be amended and the observance thereof may be waived (either generally or
10.
MISCELLANEOUS.
a.
Any notices, consents, waivers or other communications required or permitted to be given under the
terms of this Agreement must be in writing and will be deemed to have been delivered: (i) upon receipt, when delivered personally;
(ii) upon receipt, when sent by facsimile (provided confirmation of transmission is mechanically or electronically generated and
kept on file by the sending party); (iii) upon receipt, when sent by electronic message (provided the recipient responds to the
message and confirmation of both electronic messages are kept on file by the sending party); or (iv) one (1) Business Day after
timely deposit with a nationally recognized overnight delivery service, in each case properly addressed to the party to receive the
same. The addresses and facsimile numbers for such communications shall be:
If to the Company:
Recro Pharma, Inc.
490 Lapp Road
Malvern, PA 19355
Telephone: 484-395-2470
Facsimile: 484-395-2471
Attention: Michael Celano
Email: mcelano@recropharma.com
With a copy (which shall not constitute notice) to:
Pepper Hamilton LLP
3000 Two Logan Square
Eighteenth and Arch Streets
Philadelphia, PA 19103
Telephone: 215-981-4331
Facsimile: 215-981-4750
Attention: Rachael M. Bushey
Email: busheyr@pepperlaw.com
If to the Buyer:
Aspire Capital Fund, LLC
155 North Wacker Drive, Suite 1600
Chicago, IL 60606
Telephone: 312-658-0400
Facsimile: 312-658-4005
Attention: Steven G. Martin
Email: smartin@aspirecapital.com
With a copy (which shall not constitute notice) to:
Morrison & Foerster LLP
2000 Pennsylvania Avenue, NW, Suite 6000
Washington, DC 20006
Telephone: 202-778-1611
Facsimile: 202-887-0763
Attention: Martin P. Dunn, Esq.
Email: mdunn@mofo.com
or at such other address and/or facsimile number and/or to the attention of such other person as the recipient party has specified by
written notice given to each other party at least one (1) Business Day prior to the effectiveness of such change. Written confirmation
of receipt (A) given by the recipient of such notice, consent, waiver or other communication, (B) mechanically or electronically
generated by the sender’s facsimile machine containing the time, date, and recipient facsimile number, (C) electronically generated
by the sender’s electronic mail containing the time, date and recipient email address or (D) provided by a nationally recognized
overnight delivery service, shall be rebuttable evidence of receipt in accordance with clause (i), (ii), (iii) or (iv) above,
respectively. Any party to this Agreement may give any notice or other communication hereunder using any other means (including
messenger service, ordinary mail or electronic mail), but no such notice or other communication shall be deemed to have been duly
given unless it actually is received by the party for whom it is intended.
No failure or delay in the exercise of any power, right or privilege hereunder shall operate as a waiver
thereof, nor shall any single or partial exercise of any such power, right or privilege preclude other or further exercise thereof or of
any other right, power or privilege.
b.
c.
The corporate laws of the Commonwealth of Pennsylvania shall govern all issues concerning the
relative rights of the Company and its shareholders. All other questions concerning the construction, validity, enforcement and
interpretation of this Agreement shall be governed by the internal laws of the State of Illinois, without giving effect to any choice of
law or conflict of law provision or rule (whether of the State of Illinois or any other jurisdictions) that would cause the application of
the laws of any jurisdictions other than the State of Illinois. Each party hereby irrevocably submits to the exclusive jurisdiction of
the state and federal courts sitting in the City of Chicago for the adjudication of any dispute hereunder or in connection herewith or
with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit,
action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or
proceeding is brought in an inconvenient forum or that the venue of such suit, action or proceeding is improper. Each party hereby
irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by
mailing a copy thereof to such party at the address for such notices to it under this Agreement and agrees that such service shall
constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way
any right to serve process in any
manner permitted by law. If any provision of this Agreement shall be invalid or unenforceable in any jurisdiction, such invalidity or
unenforceability shall not affect the validity or enforceability of the remainder of this Agreement in that jurisdiction or the validity
or enforceability of any provision of this Agreement in any other jurisdiction. EACH PARTY HEREBY IRREVOCABLY
WAIVES ANY RIGHT IT MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF
ANY DISPUTE HEREUNDER OR IN CONNECTION HEREWITH OR ARISING OUT OF THIS AGREEMENT OR ANY
TRANSACTION CONTEMPLATED HEREBY.
d.
This Agreement, the Purchase Agreement and the other Transaction Documents constitute the entire
understanding among the parties hereto with respect to the subject matter hereof and thereof. There are no restrictions, promises,
warranties or undertakings, other than those set forth or referred to herein and therein. This Agreement, the Purchase Agreement
and the other Transaction Documents supersede all other prior oral or written agreements between the Buyer, the Company, their
affiliates and persons acting on their behalf with respect to the subject matter hereof and thereof.
upon the permitted successors and assigns of each of the parties hereto.
e.
Subject to the requirements of Section 8, this Agreement shall inure to the benefit of and be binding
the interpretation of, this Agreement.
f.
The headings in this Agreement are for convenience of reference and shall not form part of, or affect
g.
This Agreement may be executed in two or more identical counterparts, all of which shall be
considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered
to the other party; provided that a facsimile or pdf (or other electronic reproduction of a) signature shall be considered due execution
and shall be binding upon the signatory thereto with the same force and effect as if the signature were an original, not a facsimile or
pdf (or other electronic reproduction of a) signature.
h.
Each party shall do and perform, or cause to be done and performed, all such further acts and things,
and shall execute and deliver all such other agreements, certificates, instruments and documents as the other party may reasonably
request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions
contemplated hereby.
express their mutual intent and no rules of strict construction will be applied against any party.
i.
The language used in this Agreement will be deemed to be the language chosen by the parties to
successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.
j.
This Agreement is intended for the benefit of the parties hereto and their respective permitted
* * * * * *
IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of day and year first
above written.
THE COMPANY:
RECRO PHARMA, INC.
By:
Name:
Title:
/s/ Geraldine A. Henwood
Geraldine A. Henwood
Chief Executive Officer
BUYER:
ASPIRE CAPITAL FUND, LLC
BY:
BY:
ASPIRE CAPITAL PARTNERS, LLC
CHRISKO INVESTORS, INC.
By:
Name:
Title:
/s/ Christos Komissopoulos
Christos Komissopoulos
President
EXHIBIT A
Information About The Buyer Furnished To The Company By The Buyer
Expressly For Use In Connection With The Registration Statement and Prospectus
Aspire Capital Partners LLC (“Aspire Partners”) is the Managing Member of Aspire Capital Fund LLC (“Aspire Fund”). SGM
Holdings Corp (“SGM”) is the Managing Member of Aspire Partners. Mr. Steven G. Martin (“Mr. Martin”) is the president and
sole shareholder of SGM, as well as a principal of Aspire Partners. Mr. Erik J. Brown (“Mr. Brown”) is the president and sole
shareholder of Red Cedar Capital Corp (“Red Cedar”), which is a principal of Aspire Partners. Mr. Christos Komissopoulos (“Mr.
Komissopoulos”) is president and sole shareholder of Chrisko Investors Inc. (“Chrisko”), which is a principal of Aspire
Partners. Mr. William F. Blank, III (“Mr. Blank”) is president and sole shareholder of WML Ventures Corp. (“WML Ventures”),
which is a principal of Aspire Partners. Each of Aspire Partners, SGM, Red Cedar, Chrisko, WML Ventures, Mr. Martin, Mr.
Brown, Mr. Komissopoulos and Mr. Blank may be deemed to be a beneficial owner of common stock held by Aspire Fund. Each of
Aspire Partners, SGM, Red Cedar, Chrisko, WML Ventures, Mr. Martin, Mr. Brown, Mr. Komissopoulos and Mr. Blank disclaims
beneficial ownership of the common stock held by Aspire Fund.
Exhibit 5.1
3000 Two Logan Square
Eighteenth and Arch Streets
Philadelphia, PA 19103-2799
215.981.4000
Fax 215.981.4750
February 19, 2019
Board of Directors of Recro Pharma, Inc.
490 Lapp Road
Malvern, Pennsylvania 19355
Ladies and Gentlemen:
We are acting as counsel to Recro Pharma, Inc., a Pennsylvania corporation (the “Company”), in connection with the
Company’s issuance of up to $20,000,000 of shares (the “Purchase Shares”) of the Company’s common stock, par value $0.01
per share (the “Common Stock”), and an addition 34,762 shares of Common Stock (the “Commitment Shares”, and together
with the Purchase Shares, the “Shares”), pursuant to that certain Common Stock Purchase Agreement, dated February 19, 2019
(the “Agreement”), by and between the Company and Aspire Capital Fund, LLC (“Aspire”). The Shares will be sold by the
Company pursuant to the Company’s registration statement on Form S-3 under the Securities Act of 1933, as amended (the
“Act”), filed with the Securities and Exchange Commission (the “Commission”) on June 2, 2017 and declared effective by the
Commission on June 12, 2017 (the “Registration Statement”), a base prospectus dated June 12, 2017 (the “Base Prospectus”)
and a final prospectus supplement dated February 19, 2019 (together with the Base Prospectus, the “Prospectus”). This opinion
letter is furnished to you at your request to enable you to fulfill the requirements of Item 601(b)(5) of Regulation S-K, 17 C.F.R.
§ 229.601(b)(5), in connection with the issuance of the Shares.
For purposes of this opinion letter, we have examined copies of such agreements, instruments and documents as we have deemed
an appropriate basis on which to render the opinions hereinafter expressed. In our examination of the aforesaid documents, we
have assumed the genuineness of all signatures, the legal capacity of all natural persons, the accuracy and completeness of all
documents submitted to us, the authenticity of all original documents, and the conformity to authentic original documents of all
documents submitted to us as copies (including pdfs). As to all matters of fact, we have relied on the representations and
statements of fact made in the documents so reviewed, and we have not independently established the facts so relied on. This
opinion letter is given, and all statements herein are made, in the context of the foregoing.
This opinion letter is based as to matters of law solely on the Pennsylvania Business Corporation Law of 1988, as amended. We
express no opinion herein as to any other statutes, rules or regulations.
Based upon, subject to and limited by the foregoing, we are of the opinion that following: (i) issuance of the Shares pursuant to
the terms of the Agreement and (ii) receipt by the Company of the consideration for the Shares specified in the resolutions of the
Board of Directors, the Shares will be validly issued, fully paid, and nonassessable.
This opinion letter has been prepared for use in connection with the filing by the Company of an Annual Report on Form 10-K
relating to the offer and sale of the Shares, which Form 10-K will be incorporated by
1
Recro Pharma,
Inc.
February 19,
2019
reference into the Registration Statement and Prospectus, and speaks as of the date hereof. We assume no obligation to advise
you of any changes in the foregoing subsequent to the delivery of this letter.
We hereby consent to the filing of this opinion letter as Exhibit 5.1 to the above-described Form 10-K and to the reference to this
firm under the caption “Legal Matters” in the Prospectus. In giving this consent, we do not thereby admit that we are an “expert”
within the meaning of the Act.
Very truly yours,
/s/ Pepper Hamilton LLP
PEPPER HAMILTON LLP
2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the omitted portions.
Exhibit 10.26
395 Pine Tree Road, Suite 310
Ithaca, New York 14850
p- 607-254-4698
f. 607-254-5454
www.ctl.cornell.edu
October 31, 2018
Jyrki Mattila, PhD
Executive Vice President of Business Development
Recro Pharma, Inc.
490 Lapp Road, Malvern PA 19355
Email: jmattila@recropharma.com
RE:
AMENDMENT
to the License Agreement by and between Recro Pharma, Inc. (hereinafter “LICENSEE”) and Cornell
University (“Cornell”), as represented by its Center for Technology Licensing at Cornell University
(hereinafter “CTL”) effective June 30, 2017, and amended effective October 24, 2017 (Cornell Contract
#C2017-12-10946)
Effective as of the date of the last signature below (“Second Amendment Date”), the undersigned parties agree to
hereby modify the License Agreement referenced above as follows:
1)
In Paragraph 3.3 Due Diligence, replace (a)(ii) and (a)(iii) with the following:
(ii) [***];
(iii) [***];
2)
These changes do not otherwise change the terms and conditions of the Agreement.
IN WITNESS THEREOF, the parties have caused this instrument to be executed in duplicate as of the
Amendment Date written above.
Cornell University
Recro Pharma, Inc.
By:
/s/ Brian J. Kelly, PhD
By:
/s/ G. A. Henwood
Name:
Title:
Brian J. Kelly, PhD
Director, Technology Licensing
Name:
Title:
G.A. Henwood
CEO & President
Date:
November 29, 2018
Date:
November 27, 2018
Exhibit 10.34
COMMON STOCK PURCHASE AGREEMENT
COMMON STOCK PURCHASE AGREEMENT (the “Agreement”), dated as of February 19, 2019, by and between RECRO
PHARMA, INC., a Pennsylvania corporation (the “Company”), and ASPIRE CAPITAL FUND, LLC, an Illinois limited liability
company (the “Buyer”). Capitalized terms used herein and not otherwise defined herein are defined in Section 10 hereof.
WHEREAS:
Subject to the terms and conditions set forth in this Agreement, the Company wishes to sell to the Buyer, and the Buyer wishes to buy
from the Company, up to Twenty Million Dollars ($20,000,000) of the Company’s common stock, par value $0.01 per share (the
“Common Stock”). The shares of Common Stock to be purchased hereunder are referred to herein as the “Purchase Shares.”
NOW THEREFORE, the Company and the Buyer hereby agree as follows:
1.
PURCHASE OF COMMON STOCK.
Subject to the terms and conditions set forth in this Agreement, the Company has the right to sell to the Buyer, and the Buyer has the
obligation to purchase from the Company, Purchase Shares as follows:
(a) Commencement of Purchases of Common Stock. Immediately upon Commencement (as defined below), the purchase and sale of
Purchase Shares hereunder shall occur from time to time upon written notices by the Company to the Buyer on the terms and conditions as
set forth herein following the satisfaction of the conditions (the “Commencement”) as set forth in Sections 6 and 7 below (the date of
satisfaction of such conditions, the “Commencement Date”).
(b) The Company’s Right to Require Regular Purchases. Subject to the terms and conditions of this Agreement, on any given Business
Day after the Commencement Date, the Company shall have the right but not the obligation to direct the Buyer by its delivery to the Buyer
of a Purchase Notice from time to time, and the Buyer thereupon shall have the obligation, to buy the number of Purchase Shares specified
in such notice, up to a maximum of 75,000 Purchase Shares, on such Business Day (as long as such notice is delivered on or before 5:00
p.m. Eastern time on such Business Day) (each such purchase, a “Regular Purchase”) at the Purchase Price on the Purchase Date;
however, in no event shall the Purchase Amount of a Regular Purchase exceed Five Hundred Thousand Dollars ($500,000) per Business
Day, unless the Buyer and the Company mutually agree. The Company and the Buyer may mutually agree to increase the number of
Purchase Shares that may be sold per a Regular Purchase to as much as an additional 2,000,000 Purchase Shares per Business Day. The
Company may deliver additional Purchase Notices to the Buyer from time to time so long as the most recent purchase has been completed.
The share amounts in the first sentence of this Section 1(b) shall be appropriately adjusted for any reorganization, recapitalization, stock
dividend, stock split, reverse stock split, or other similar transaction.
(c) VWAP Purchases. Subject to the terms and conditions of this Agreement, in addition to purchases of Purchase Shares as described
in Section 1(b) above, with one Business Day’s prior written notice (as long as such notice is delivered on or before 5:00 p.m. Eastern time
on the Business Day immediately preceding the VWAP Purchase Date), the Company shall also have the right but not the obligation to
direct the Buyer by the Company’s delivery to the Buyer of a VWAP Purchase Notice from time to time, and the Buyer thereupon shall
have the obligation, to buy the VWAP Purchase Share Percentage of the trading volume of the Common Stock on the VWAP Purchase
Date up to the VWAP Purchase Share Volume Maximum on the VWAP Purchase Date (each such purchase, a “VWAP Purchase”) at the
VWAP Purchase Price. The Company may deliver a VWAP Purchase Notice to the Buyer on or before 5:00 p.m. Eastern time on a date on
which the Company also submitted a Purchase Notice for a Regular Purchase of at least 75,000 Purchase Shares to the Buyer. The share
amount in the prior sentence shall be appropriately adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse
stock split, or other similar transaction. A VWAP Purchase shall automatically be deemed completed at such time on the VWAP Purchase
Date that the Sale Price falls below the VWAP Minimum Price Threshold; in such circumstance, the VWAP Purchase Amount shall be
calculated using (i) the VWAP Purchase Share Percentage of the aggregate shares traded on the Principal Market for such portion of the
VWAP Purchase Date prior to the time that the Sale Price fell below the VWAP Minimum Price Threshold and (ii) a VWAP Purchase
Price calculated using the volume weighted average price of Common Stock sold during such portion of the VWAP Purchase Date prior to
the time that the Sale Price fell below the VWAP Minimum Price Threshold. Each VWAP Purchase Notice must be accompanied by
instructions to the Company’s Transfer Agent to immediately issue to the Buyer an amount of Common Stock equal to the VWAP Purchase
Share Estimate, a good faith estimate by the Company of the number
of Purchase Shares that the Buyer shall have the obligation to buy pursuant to the VWAP Purchase Notice. In no event shall the Buyer,
pursuant to any VWAP Purchase, purchase a number of Purchase Shares that exceeds the VWAP Purchase Share Estimate issued on the
VWAP Purchase Date in connection with such VWAP Purchase Notice; however, the Buyer will immediately return to the Company any
amount of Common Stock issued pursuant to the VWAP Purchase Share Estimate that exceeds the number of Purchase Shares the Buyer
actually purchases in connection with such VWAP Purchase. Upon completion of each VWAP Purchase Date, the Buyer shall submit to the
Company a confirmation of the VWAP Purchase in form and substance reasonably acceptable to the Company. The Company may deliver
additional VWAP Purchase Notices to the Buyer from time to time so long as the most recent purchase has been completed. The Company
may, by written notice to the Buyer, in its sole discretion at any time after the date of this Agreement, irrevocably terminate this Section 1(c)
and its right to direct the Buyer to make VWAP Purchases.
(d) Payment for Purchase Shares. For each Regular Purchase, the Buyer shall pay to the Company an amount equal to the Purchase
Amount as full payment for such Purchase Shares via wire transfer of immediately available funds on the same Business Day that the
Buyer receives such Purchase Shares. For each VWAP Purchase, the Buyer shall pay to the Company an amount equal to the VWAP
Purchase Amount as full payment for such Purchase Shares via wire transfer of immediately available funds on the second Business Day
following the VWAP Purchase Date. All payments made under this Agreement shall be made in lawful money of the United States of
America via wire transfer of immediately available funds to such account as the Company may from time to time designate by written
notice in accordance with the provisions of this Agreement. Whenever any amount expressed to be due by the terms of this Agreement is
due on any day that is not a Business Day, the same shall instead be due on the next succeeding day that is a Business Day.
(e) Purchase Price Floor. The Company and the Buyer shall not effect any sales under this Agreement on any Purchase Date where the
Closing Sale Price is less than the Floor Price. “Floor Price” means $0.50 per share of Common Stock, which shall be appropriately
adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction.
(f) Records of Purchases. The Buyer and the Company shall each maintain records showing the remaining Available Amount at any
given time and the dates and Purchase Amounts for each purchase, or shall use such other method reasonably satisfactory to the Buyer and
the Company to reconcile the remaining Available Amount.
(g) Taxes. The Company shall pay any and all transfer, stamp or similar taxes that may be payable with respect to the issuance and
delivery of any shares of Common Stock to the Buyer made under this Agreement.
(h) Compliance with Principal Market Rules. Notwithstanding anything in this Agreement to the contrary, and in addition to the
limitations set forth in Section 1(e), the total number of shares of Common Stock that may be issued under this Agreement, including the
Commitment Shares (as defined in Section 4(e) hereof), shall be limited to 4,372,373 shares of Common Stock (the “Exchange Cap”),
which equals 19.99% of the Company’s outstanding shares of Common Stock as of the date hereof, unless shareholder approval is obtained
to issue more than such 19.99%. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, stock dividend,
stock split, reverse stock split or similar transaction. The foregoing limitation shall not apply if shareholder approval has not been obtained
and at any time the Exchange Cap is reached and at all times thereafter the average price paid for all shares of Common Stock issued under
this Agreement is equal to or greater than $8.63 (the “Minimum Price”), a price equal to the lower of (1) the Closing Sale Price
immediately preceding the execution of this Agreement or (2) the arithmetic average of the five (5) Closing Sale Prices for the Common
Stock immediately preceding the execution of this Agreement (in such circumstance, for purposes of the Principal Market, the transaction
contemplated hereby would not be “below market” and the Exchange Cap would not apply). The Minimum Price shall be appropriately
adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction. Notwithstanding
anything to the contrary in this Agreement or otherwise, the Company shall not be required or permitted to issue, and the Buyer shall not be
required to purchase, any shares of Common Stock under this Agreement if such issuance would breach the Company’s obligations under
the rules or regulations of the Principal Market. The Company may, in its sole discretion, determine whether to obtain shareholder approval
to issue more than 19.99% of its outstanding shares of Common Stock hereunder if such issuance would require shareholder approval under
the rules or regulations of the Principal Market.
(i) Beneficial Ownership Limitation. The Company shall not issue and the Buyer shall not purchase any shares of Common Stock
under this Agreement if such shares proposed to be issued and sold, when aggregated with all other shares of Common Stock then owned
beneficially (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended (the “1934 Act”) and Rule 13d-3
promulgated thereunder) by the Buyer and its affiliates would result in the beneficial ownership by the Buyer and its affiliates of more than
19.99% of the then issued and outstanding shares of Common Stock of the Company.
2.
BUYER’S REPRESENTATIONS AND WARRANTIES.
The Buyer represents and warrants to the Company that as of the date hereof and as of the Commencement Date:
(a) Investment Purpose. The Buyer is entering into this Agreement and acquiring the Commitment Shares and the Purchase Shares (the
Purchase Shares and the Commitment Shares are collectively referred to herein as the “Securities”), for its own account for investment
only and not with a view towards, or for resale in connection with, the public sale or distribution thereof; provided however, by making the
representations herein, the Buyer does not agree to hold any of the Securities for any minimum or other specific term.
(b) Accredited Investor Status. The Buyer is an “accredited investor” as that term is defined in Rule 501(a)(3) of Regulation D under
the 1933 Act.
(c) [Intentionally Omitted.]
(d) Information. The Buyer has been furnished with all materials relating to the business, finances and operations of the Company and
materials relating to the offer and sale of the Securities that have been reasonably requested by the Buyer, including, without limitation, the
SEC Documents (as defined in Section 3(f) hereof). The Buyer understands that its investment in the Securities involves a high degree of
risk. The Buyer (i) is able to bear the economic risk of an investment in the Securities including a total loss, (ii) has such knowledge and
experience in financial and business matters that it is capable of evaluating the merits and risks of the proposed investment in the Securities
and (iii) has had an opportunity to ask questions of and receive answers from the officers of the Company concerning the financial
condition and business of the Company and other matters related to an investment in the Securities. Neither such inquiries nor any other
due diligence investigations conducted by the Buyer or its representatives shall modify, amend or affect the Buyer’s right to rely on the
Company’s representations and warranties contained in Section 3 below. The Buyer has sought such accounting, legal and tax advice as it
has considered necessary to make an informed investment decision with respect to its acquisition of the Securities.
(e) No Governmental Review . The Buyer understands that no United States federal or state agency or any other government or
governmental agency has passed on or made any recommendation or endorsement of the Securities or the fairness or suitability of the
investment in the Securities nor have such authorities passed upon or endorsed the merits of the offering of the Securities.
(f) [Intentionally Omitted.]
(g) Organization. The Buyer is a limited liability company duly organized and validly existing in good standing under the laws of the
jurisdiction in which it is organized, and has the requisite organizational power and authority to own its properties and to carry on its
business as now being conducted.
(h) Validity; Enforcement. This Agreement has been duly and validly authorized, executed and delivered on behalf of the Buyer and is
a valid and binding agreement of the Buyer enforceable against the Buyer in accordance with its terms, subject as to enforceability to (i)
general principles of equity and to applicable bankruptcy, insolvency, reorganization, moratorium, liquidation and other similar laws
relating to, or affecting generally, the enforcement of applicable creditors’ rights and remedies and (ii) public policy underlying any law,
rule or regulation (including any federal or state securities law, rule or regulation) with regards to indemnification, contribution or
exculpation. The execution and delivery of the Transaction Documents (as defined in Section 3(b) hereof) by the Buyer and the
consummation by it of the transactions contemplated hereby and thereby do not conflict with the Buyer’s certificate of organization or
operating agreement or similar documents, and do not require further consent or authorization by the Buyer, its managers or its members.
(i) Residency. The Buyer is a resident of the State of Illinois.
(j) No Prior Short Selling. The Buyer represents and warrants to the Company that at no time prior to the date of this Agreement has
any of the Buyer, its agents, representatives or affiliates engaged in or effected, in any manner whatsoever, directly or indirectly, any (i)
“short sale” (as such term is defined in Section 242.200 of Regulation SHO of the 1934 Act) of the Common Stock or (ii) hedging
transaction, which establishes a net short position with respect to the Common Stock.
3.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
The Company represents and warrants to the Buyer that as of the date hereof and as of the Commencement Date:
(a) Organization and Qualification. The Company and its “Subsidiaries” (which for purposes of this Agreement means any
entity in which the Company, directly or indirectly, owns more than 50% of the voting stock or capital stock or other similar equity
interests) are corporations or limited liability companies duly organized and validly existing in good standing under the laws of the
jurisdiction in which they are incorporated or organized, and have the requisite corporate or organizational power and authority to own their
properties and to carry on their business as now being conducted. Each of the Company and its Subsidiaries is duly qualified as a foreign
corporation or limited liability company to do business and is in good standing in every jurisdiction in which its ownership of property or
the nature of the business conducted by it makes such qualification necessary, except to the extent that the failure to be so qualified or be in
good standing could not reasonably be expected to have a Material Adverse Effect. As used in this Agreement, “Material Adverse Effect”
means any material adverse effect on any of: (i) the business, properties, assets, operations, results of operations or financial condition of
the Company and its Subsidiaries, if any, taken as a whole, or (ii) the authority or ability of the Company to perform its obligations under
the Transaction Documents (as defined in Section 3(b) hereof). The Company has no material Subsidiaries except as set forth on Section
3(a) of the disclosure letter delivered by the Company to Buyer pursuant to this Agreement (the “Disclosure Letter”).
(b) Authorization; Enforcement; Validity. (i) The Company has the requisite corporate power and authority to enter into and perform
its obligations under this Agreement, the Registration Rights Agreement (as defined in Section 4(a) hereof) and each of the other
agreements entered into by the parties on the Commencement Date and attached hereto as exhibits to this Agreement (collectively, the
“Transaction Documents”), and to issue the Securities in accordance with the terms hereof and thereof, (ii) the execution and delivery of
the Transaction Documents by the Company and the consummation by it of the transactions contemplated hereby and thereby, including
without limitation, the issuance of the Commitment Shares and the reservation for issuance and the issuance of the Purchase Shares
issuable under this Agreement, have been duly authorized by the Company’s Board of Directors or duly authorized committee thereof, do
not conflict with the Company’s Articles of Incorporation or Bylaws (as defined below), and do not require further consent or authorization
by the Company, its Board of Directors, except as set forth in this Agreement, or its shareholders (other than as contemplated by Section
1(h) hereof), (iii) this Agreement has been, and each other Transaction Document shall be on the Commencement Date, duly executed and
delivered by the Company and (iv) this Agreement constitutes, and each other Transaction Document upon its execution on behalf of the
Company, shall constitute, the valid and binding obligations of the Company enforceable against the Company in accordance with their
terms, except as such enforceability may be limited by (y) general principles of equity or applicable bankruptcy, insolvency, reorganization,
moratorium, liquidation or similar laws relating to, or affecting generally, the enforcement of creditors’ rights and remedies and (z) public
policy underlying any law, rule or regulation (including any federal or state securities law, rule or regulation) with regards to
indemnification, contribution or exculpation. The Board of Directors of the Company or duly authorized committee thereof has approved
the resolutions (the “Signing Resolutions”) substantially in the form as set forth as Exhibit B attached hereto to authorize this Agreement
and the transactions contemplated hereby. The Signing Resolutions are valid, in full force and effect and have not been modified or
supplemented in any material respect. The Company has delivered to the Buyer a true and correct copy of the Signing Resolutions as
approved by the Board of Directors of the Company.
(c) Capitalization. As of the date hereof, the authorized capital stock of the Company consists of (i) 50,000,000 shares of Common
Stock, par value $0.01, of which as of the date hereof, 21,872,803 shares are issued and outstanding, zero shares are held as treasury shares,
4,969,364 shares are issuable upon the exercise of stock options outstanding, 1,410,720 shares are issuable upon the vesting and settlement
of restricted stock units outstanding; 2,202,887 shares of Common Stock are reserved and available for future issuance under the
Company’s Amended and Restated Equity Incentive Plan; and 838,664 shares of Common Stock are issuable upon the exercise of
outstanding warrants and (ii) 10,000,000 shares of preferred stock, of which as of the date hereof zero shares are issued and outstanding.
All of such outstanding shares have been, or upon issuance will be, validly issued and are fully paid and non-assessable. Except as
disclosed in Section 3(c) of the Disclosure Letter, (i) no shares of the Company’s capital stock are subject to preemptive rights or any other
similar rights or any liens or encumbrances suffered or permitted by the Company, (ii) there are no outstanding debt securities of the
Company or any of its Subsidiaries, (iii) there are no outstanding options, warrants, scrip, rights to subscribe to, calls or commitments of
any character whatsoever relating to, or securities or rights convertible into, any shares of capital stock of the Company or any of its
Subsidiaries, or contracts, commitments, understandings or arrangements by which the Company or any of its Subsidiaries is or may
become bound to issue additional shares of capital stock of the Company or any of its Subsidiaries or options, warrants, scrip, rights to
subscribe to, calls or commitments of any character whatsoever relating to, or securities or rights convertible into, any shares of capital
stock of the Company or any of its Subsidiaries, (iv) there are no material agreements or arrangements under which the Company or any of
its Subsidiaries is obligated to register the sale of any of their securities under the 1933 Act (except the Registration Rights Agreement), (v)
there are no outstanding securities or instruments of the Company or any of its Subsidiaries which contain any redemption or similar
provisions, and there are no contracts, commitments, understandings or arrangements by which the Company or any of its Subsidiaries is or
may become bound to redeem a security of the Company or any of its Subsidiaries, (vi) there are no securities or instruments containing
anti-dilution or similar provisions that will be triggered by the issuance of the Securities as described in this Agreement and (vii) the
Company does not have any stock appreciation rights
or “phantom stock” plans or agreements or any similar plan or agreement. The Company has furnished or made available to the Buyer true
and correct copies of the Company’s Second Amended and Restated Articles of Incorporation, as in effect on the date hereof (the “Articles
of Incorporation”), and the Company’s Third Amended and Restated Bylaws, as in effect on the date hereof (the “Bylaws”).
(d) Issuance of Securities. The Commitment Shares have been duly authorized and, upon issuance in accordance with the terms hereof,
the Commitment Shares shall be (i) validly issued, fully paid and non-assessable and (ii) free from all taxes, liens and charges with respect
to the issuance thereof. Upon issuance and payment therefore in accordance with the terms and conditions of this Agreement, the Purchase
Shares shall be validly issued, fully paid and non-assessable and free from all taxes, liens and charges with respect to the issue thereof, with
the holders being entitled to all rights accorded to a holder of Common Stock.
(e) No Conflicts. The execution, delivery and performance of the Transaction Documents by the Company and the consummation by
the Company of the transactions contemplated hereby and thereby (including, without limitation, the reservation for issuance and issuance
of the Purchase Shares) will not (i) result in a violation of the Articles of Incorporation, any Certificate of Designations, Preferences and
Rights of any outstanding series of preferred stock of the Company, or the Bylaws or (ii) conflict with, or constitute a default (or an event
which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment,
acceleration or cancellation of, any agreement, indenture or instrument to which the Company or any of its Subsidiaries is a party, or result,
to the Company’s knowledge, in a violation of any law, rule, regulation, order, judgment or decree (including federal and state securities
laws and regulations and the rules and regulations of the Principal Market applicable to the Company or any of its Subsidiaries) or by which
any property or asset of the Company or any of its Subsidiaries is bound or affected, except in the case of conflicts, defaults, terminations,
amendments, accelerations, cancellations and violations under clause (ii), which could not reasonably be expected to result in a Material
Adverse Effect. Neither the Company nor its Subsidiaries is in violation of any term of or in default under its Articles of Incorporation,
including any Certificate of Designation, Preferences and Rights of any outstanding series of preferred stock of the Company, or Bylaws or
their organizational charter or bylaws, respectively. Neither the Company nor any of its Subsidiaries is in violation of any term of or is in
default under any material contract, agreement, mortgage, indebtedness, indenture, instrument, judgment, decree or order or any statute, rule
or regulation applicable to the Company or its Subsidiaries, except for possible violations, defaults, terminations or amendments that could
not reasonably be expected to have a Material Adverse Effect. The business of the Company and its Subsidiaries is not being conducted,
and shall not be conducted, in violation of any law, ordinance, or regulation of any governmental entity, except for possible violations, the
sanctions for which either individually or in the aggregate could not reasonably be expected to have a Material Adverse Effect. Except as
specifically contemplated by this Agreement, reporting obligations under the 1934 Act or as required under the 1933 Act or applicable state
securities laws or the filing of a Listing of Additional Shares Notification Form with the Principal Market, the Company is not required to
obtain any consent, authorization or order of, or make any filing or registration with, any court or governmental agency or any regulatory or
self-regulatory agency in order for it to execute, deliver or perform any of its obligations under or contemplated by the Transaction
Documents in accordance with the terms hereof or thereof. Except for reporting obligations under the 1934 Act, all consents,
authorizations, orders, filings and registrations which the Company is required to obtain pursuant to the preceding sentence shall be
obtained or effected on or prior to the Commencement Date. The Company is not subject to any notices or actions from or to the Principal
Market, other than routine matters incident to listing on the Principal Market and not involving a violation of the rules of the Principal
Market. To the Company’s knowledge, the Principal Market has not commenced any delisting proceedings against the Company.
(f) SEC Documents; Financial Statements. Since September 30, 2017, the Company has filed all reports, schedules, forms, statements
and other documents required to be filed by it with the SEC pursuant to the reporting requirements of the 1934 Act (all of the foregoing
filed prior to the date hereof and all exhibits included therein and financial statements and schedules thereto and documents incorporated by
reference therein being hereinafter referred to as the “SEC Documents”). As of their respective dates (except as they have been correctly
amended), the SEC Documents complied in all material respects with the requirements of the 1934 Act and the rules and regulations of the
SEC promulgated thereunder applicable to the SEC Documents, and none of the SEC Documents, at the time they were filed with the SEC
(except as they may have been properly amended), contained any untrue statement of a material fact or omitted to state a material fact
required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made,
not misleading. As of their respective dates (except as they have been properly amended), the financial statements of the Company
included in the SEC Documents complied as to form in all material respects with applicable accounting requirements and the published
rules and regulations of the SEC with respect thereto. Such financial statements have been prepared in accordance with generally accepted
accounting principles, consistently applied, during the periods involved (except (i) as may be otherwise indicated in such financial
statements or the notes thereto or (ii) in the case of unaudited interim statements, to the extent they may exclude footnotes or may be
condensed or summary statements) and fairly present in all material respects the financial position of the Company as of the dates thereof
and the results of its operations and cash flows for the periods then ended (subject, in the case
of unaudited statements, to normal year-end audit adjustments). Except for routine correspondence, such as comment letters and notices of
effectiveness in connection with previously filed registration statements or periodic reports publicly available on EDGAR, to the
Company’s knowledge, the Company or any of its Subsidiaries are not presently the subject of any inquiry, investigation or action by the
SEC.
(g) Absence of Certain Changes. Since September 30, 2018, there has been no material adverse change in the business, properties,
operations, financial condition or results of operations of the Company or its Subsidiaries taken as a whole. For purposes of this Agreement,
neither a decrease in cash or cash equivalents or in the market price of the Common Stock nor losses incurred in the ordinary course of the
Company’s business shall be deemed or considered a material adverse change. The Company has not taken any steps, and does not
currently expect to take any steps, to seek protection pursuant to any Bankruptcy Law nor does the Company or any of its Subsidiaries have
any knowledge or reason to believe that its creditors intend to initiate involuntary bankruptcy or insolvency proceedings. The Company is
financially solvent and is generally able to pay its debts as they become due.
(h) Absence of Litigation. Except as disclosed in Section 3(h) of the Disclosure Letter, there is no action, suit, proceeding, inquiry or
investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge
of the Company or any of its Subsidiaries, threatened against the Company, the Common Stock or any of the Company’s Subsidiaries or
any of the Company’s or the Company’s Subsidiaries’ officers or directors in their capacities as such, which could reasonably be expected
to have a Material Adverse Effect (each, an “Action”).
(i) Acknowledgment Regarding Buyer’s Status. The Company acknowledges and agrees that the Buyer is acting solely in the capacity
of arm’s length purchaser with respect to the Transaction Documents and the transactions contemplated hereby and thereby. The Company
further acknowledges that the Buyer is not acting as a financial advisor or fiduciary of the Company (or in any similar capacity) with
respect to the Transaction Documents and the transactions contemplated hereby and thereby and any advice given by the Buyer or any of its
representatives or agents in connection with the Transaction Documents and the transactions contemplated hereby and thereby is merely
incidental to the Buyer’s purchase of the Securities. The Company further represents to the Buyer that the Company’s decision to enter into
the Transaction Documents has been based solely on the independent evaluation by the Company and its representatives and advisors.
(j) Intellectual Property Rights. To the Company’s knowledge, the Company and its Subsidiaries own or possess adequate rights or
licenses to use all material trademarks, trade names, service marks, service mark registrations, service names, patents, patent rights,
copyrights, inventions, licenses, approvals, governmental authorizations, trade secrets and other intellectual property rights (collectively,
“Intellectual Property”) necessary to conduct their respective businesses as now conducted, except to the extent that the failure to own,
possess, license or otherwise hold adequate rights to use Intellectual Property would not, individually or in the aggregate, have a Material
Adverse Effect. To the Company’s knowledge, none of the Company’s active and registered Intellectual Property have expired or
terminated, or, by the terms and conditions thereof, will expire or terminate within two years from the date of this Agreement, except as
would not reasonably be expected to have a Material Adverse Effect. The Company and its Subsidiaries do not have any knowledge of any
infringement by the Company or its Subsidiaries of any Intellectual Property of others, or of any such development of similar or identical
trade secrets or technical information by others with respect to the Company’s or its Subsidiaries’ Intellectual Property and, there is no
claim, action or proceeding being made or brought against, or to the Company’s knowledge, being threatened against, the Company or its
Subsidiaries regarding Intellectual Property, which could reasonably be expected to have a Material Adverse Effect.
(k) Environmental Laws. To the Company’s knowledge, the Company and its Subsidiaries (i) are in material compliance with any and
all applicable foreign, federal, state and local laws and regulations relating to the protection of the environment or human health and safety
and with respect to hazardous or toxic substances or wastes, pollutants or contaminants (“Environmental Laws”), (ii) have received all
material permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses
and (iii) are in material compliance with all terms and conditions of any such permit, license or approval, except where, in each of the three
foregoing clauses, the failure to so comply or receive such approvals could not reasonably be expected to have, individually or in the
aggregate, a Material Adverse Effect.
(l) Title. The Company and its Subsidiaries have good and marketable title to all personal property owned by them that is material to
the business of the Company and its Subsidiaries, in each case free and clear of all liens, encumbrances and defects except such as are
described in Section 3(l) of the Disclosure Letter or such as do not materially affect the value of such property and do not interfere with the
use made and proposed to be made of such property by the Company and any of its Subsidiaries or could not reasonably be expected to
have, individually or in the aggregate, a Material Adverse Effect. Any real property and facilities held under lease by the Company and any
of its Subsidiaries, to the Company’s knowledge, are held by them under valid, subsisting and enforceable leases with such exceptions as
are not material and do not interfere with the use
made and proposed to be made of such property and buildings by the Company and its Subsidiaries.
(m) Insurance. The Company and each of its Subsidiaries are insured by insurers of recognized financial responsibility against such
losses and risks and in such amounts as management of the Company believes to be reasonable and customary in the businesses in which
the Company and its Subsidiaries are engaged. To the Company’s knowledge, since December 31, 2017, neither the Company nor any such
Subsidiary has been refused any insurance coverage sought or applied for and neither the Company nor any such Subsidiary, to the
Company’s knowledge, will be unable to renew its existing insurance coverage as and when such coverage expires or to obtain similar
coverage from similar insurers as may be necessary to continue its business at a cost that would not reasonably be expected to have a
Material Adverse Effect.
(n) Regulatory Permits. The Company and its Subsidiaries possess all material certificates, authorizations and permits issued by the
appropriate federal, state or foreign regulatory authorities necessary to conduct their respective businesses as currently conducted, and
neither the Company nor any such Subsidiary has received any written notice of proceedings relating to the revocation or modification of
any such material certificate, authorization or permit.
(o) Tax Status. The Company and each of its Subsidiaries has made or filed all federal and state income and all other material tax
returns, reports and declarations required by any jurisdiction to which it is subject (unless and only to the extent that the Company and each
of its Subsidiaries has set aside on its books reserves reasonably adequate for the payment of all unpaid and unreported taxes or filed valid
extensions) and has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be
due on such returns, reports and declarations, except those being contested in good faith and has set aside on its books reserves reasonably
adequate for the payment of all taxes for periods subsequent to the periods to which such returns, reports or declarations apply. To the
Company’s knowledge, there are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction.
(p) Transactions With Affiliates. Other than the grant or exercise of stock options or any other equity securities offered pursuant to
duly adopted stock or incentive compensation plans identified in Section 3(c), none of the officers, directors or employees of the Company
is presently a party to any transaction with the Company or any of its Subsidiaries (other than for services as employees, officers and
directors and reimbursement for expenses incurred on behalf of the Company), including any contract, agreement or other arrangement
providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring
payments to or from any officer, director or such employee or, to the knowledge of the Company, any corporation, partnership, trust or
other entity in which any officer, director, or any such employee has a material interest or is an officer, director, trustee or general partner.
(q) Application of Takeover Protections. The Company and its Board of Directors have taken or will take prior to the Commencement
Date all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including
any distribution under a rights agreement) or other similar anti-takeover provision under the Articles of Incorporation or the laws of the
state of its incorporation which is or could become applicable to the Buyer as a result of the transactions contemplated by this Agreement,
including, without limitation, the Company’s issuance of the Securities and the Buyer’s ownership of the Securities.
(r) Registration Statement. The Shelf Registration Statement (as defined in Section 4(a) hereof) has been declared effective by the
SEC, and no stop order has been issued or is pending or, to the knowledge of the Company, threatened by the SEC with respect thereto. As
of the date hereof, the Company has a dollar amount of securities registered and unsold under the Shelf Registration Statement, which is not
less than the sum of (i) the Available Amount and (ii) the market value of the Commitment Shares on the date hereof.
4.
COVENANTS.
(a) Filing of Form 8-K and Prospectus Supplement. The Company agrees that it shall, within the time required under the 1934 Act, file
a Current Report on Form 8-K disclosing this Agreement and the transaction contemplated hereby or the Company may, in its discretion,
disclose this Agreement and the transactions contemplated hereby in its Annual Report on Form 10-K if filed within four Business Days
after the date of the execution of this Agreement. The Company shall file within two (2) Business Days from the date hereof a prospectus
supplement to the prospectus dated June 12, 2017 forming a part of the Company’s existing shelf registration statement on Form S-3 (File
No. 333-218487, the “Shelf Registration Statement”) covering the sale of the Commitment Shares and Purchase Shares (the “Prospectus
Supplement”) in accordance with the terms of the Registration Rights Agreement between the Company and the Buyer, dated as of the date
hereof (the “Registration Rights Agreement”). The Company shall use its reasonable best efforts to keep the Shelf Registration Statement
and any New Registration Statement (as defined in the Registration Rights Agreement) effective pursuant to Rule 415 promulgated under
the 1933 Act and available for sales of all Securities to the Buyer until such time as (i) it no longer qualifies to make sales under the
Shelf Registration Statement (which shall be understood to include the inability of the Company to immediately register sales of Securities
to the Buyer under the Shelf Registration Statement or any New Registration Statement pursuant to General Instruction I.B.6 of Form S-3),
(ii) the date on which all the Securities have been sold under this Agreement and no Available Amount remains thereunder, or (iii) the
Agreement has been terminated. The Shelf Registration Statement (including any amendments or supplements thereto and prospectuses or
prospectus supplements, including the Prospectus Supplement, contained therein) shall not contain any untrue statement of a material fact
or omit to state a material fact required to be stated therein, or necessary to make the statements therein, in light of the circumstances in
which they were made, not misleading.
(b) Blue Sky. The Company shall take such action, if any, as is reasonably necessary in order to obtain an exemption for or to qualify
(i) the initial sale of the Securities to the Buyer under this Agreement and (ii) any subsequent sale of the Securities by the Buyer, in each
case, under applicable securities or “Blue Sky” laws of the states of the United States in such states as is reasonably requested by the Buyer
from time to time, and shall provide evidence of any such action so taken to the Buyer at its written request; provided, however, that the
Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in
securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in
which it is not otherwise so subject.
(c) Listing. The Company shall promptly secure the listing of all of the Securities upon each national securities exchange and
automated quotation system that requires an application by the Company for listing, if any, upon which shares of Common Stock are then
listed (subject to official notice of issuance) and shall maintain such listing, so long as any other shares of Common Stock shall be so listed.
The Company shall use its commercially reasonable efforts to maintain the Common Stock’s listing on the Principal Market. Neither the
Company nor any of its Subsidiaries shall take any action that would be reasonably expected to result in the delisting or suspension of the
Common Stock on the Principal Market, unless the Common Stock is immediately thereafter traded on the New York Stock Exchange, the
NYSE American, the Nasdaq Global Select Market, the Nasdaq Global Market, or the Nasdaq Capital Market. The Company shall pay all
fees and expenses in connection with satisfying its obligations under this Section.
(d) Limitation on Short Sales and Hedging Transactions. The Buyer agrees that beginning on the date of this Agreement and ending on
the date of termination of this Agreement as provided in Section 11(k), the Buyer and its agents, representatives and affiliates shall not in
any manner whatsoever enter into or effect, directly or indirectly, any (i) “short sale” (as such term is defined in Section 242.200 of
Regulation SHO of the 1934 Act) of the Common Stock or (ii) hedging transaction, which establishes a net short position with respect to
the Common Stock.
(e) Issuance of Commitment Shares. In connection with the Commencement, the Company shall issue to the Buyer as consideration
for the Buyer entering into this Agreement 34,762 shares of Common Stock (the “Commitment Shares”) The Commitment Shares shall be
issued without any restrictive legend whatsoever or prior sale requirement.
(f) Due Diligence. The Buyer shall have the right, from time to time as the Buyer may reasonably deem appropriate, to perform
reasonable due diligence on the Company during normal business hours and subject to reasonable prior notice to the Company. The
Company and its officers and employees shall provide information and reasonably cooperate with the Buyer in connection with any
reasonable request by the Buyer related to the Buyer’s due diligence of the Company, including, but not limited to, any such request made
by the Buyer in connection with (i) the filing of the prospectus supplement described in Section 4(a) hereof and (ii) the Commencement;
provided, however, that at no time is the Company required to disclose material nonpublic information to the Buyer or breach any
obligation of confidentiality or non-disclosure to a third party or make any disclosure that could cause a waiver of attorney-client
privilege. Except as may be required by law, court order or governmental authority, each party hereto agrees not to disclose any
Confidential Information of the other party to any third party and shall not use the Confidential Information of such other party for any
purpose other than in connection with, or in furtherance of, the transactions contemplated hereby; provided, that to the extent such
disclosure is required by law, court order or governmental authority, the receiving party shall provide the disclosing party with reasonable
prior written notice of such disclosure and make a reasonable effort to assist the disclosing party in obtaining a protective order preventing
or limiting the disclosure and/or requiring that the Confidential Information so disclosed be used only for the purposes for which the law,
court order or governmental authority requires. Each party hereto acknowledges that the Confidential Information shall remain the
property of the disclosing party and agrees that it shall take all reasonable measures to protect the secrecy of any Confidential Information
disclosed by the other party.
5.
TRANSFER AGENT INSTRUCTIONS.
All of the Purchase Shares to be issued under this Agreement shall be issued without any restrictive legend unless the Buyer expressly
consents otherwise. The Company shall issue irrevocable instructions to the Transfer Agent, and any subsequent
transfer agent, to issue Common Stock in the name of the Buyer for the Purchase Shares (the “Irrevocable Transfer Agent
Instructions”). The Company warrants to the Buyer that no instruction other than the Irrevocable Transfer Agent Instructions referred to in
this Section 5, will be given by the Company to the Transfer Agent with respect to the Purchase Shares and that the Commitment Shares
and the Purchase Shares shall otherwise be freely transferable on the books and records of the Company as and to the extent provided in
this Agreement and the Registration Rights Agreement.
6.
CONDITIONS TO THE COMPANY’S RIGHT TO COMMENCE SALES OF SHARES OF COMMON STOCK
UNDER THIS AGREEMENT.
The right of the Company hereunder to commence sales of the Purchase Shares is subject to the satisfaction of each of the following
conditions on or before the Commencement Date (the date that the Company may begin sales of Purchase Shares):
(a) The Buyer shall have executed each of the Transaction Documents and delivered the same to the Company;
(b) The representations and warranties of the Buyer shall be true and correct as of the Commencement Date as though made at that
time (except for representations and warranties that speak as of a specific date, which shall be true and correct in all material respects as of
such specific date) and the Buyer shall have performed, satisfied and complied in all material respects with the covenants and agreements
required by this Agreement to be performed, satisfied or complied with by the Buyer at or prior to the Commencement Date; and
(c) The Prospectus Supplement shall have been delivered to the Buyer and no stop order with respect to the registration statement
covering the sale of shares to the Buyer shall be pending or threatened by the SEC.
7.
CONDITIONS TO THE BUYER’S OBLIGATION TO MAKE PURCHASES OF SHARES OF COMMON STOCK.
The obligation of the Buyer to buy Purchase Shares under this Agreement is subject to the satisfaction of each of the following
conditions on or before the Commencement Date (the date that the Company may begin sales of Purchase Shares) and once such
conditions have been initially satisfied, there shall not be any ongoing obligation to satisfy such conditions after the Commencement has
occurred:
(a) The Company shall have executed each of the Transaction Documents and delivered the same to the Buyer;
(b) The Company shall have issued to the Buyer the Commitment Shares;
(c) The Common Stock shall be authorized for quotation on the Principal Market, trading in the Common Stock shall not have been
within the last 365 days suspended by the SEC or the Principal Market, other than a general halt in trading in the Common Stock by the
Principal Market under halt codes indicating pending or released material news, and the Securities shall be approved for listing upon the
Principal Market;
(d) The Buyer shall have received the opinion of the Company’s legal counsel dated as of the Commencement Date in customary form
and substance;
(e) The representations and warranties of the Company shall be true and correct in all material respects (except to the extent that any of
such representations and warranties is already qualified as to materiality in Section 3 above, in which case, such representations and
warranties shall be true and correct without further qualification) as of the date of this Agreement and as of the Commencement Date as
though made at that time (except for representations and warranties that speak as of a specific date, which shall be true and correct in all
material respects as of such specific date) and the Company shall have performed, satisfied and complied in all material respects with the
covenants, agreements and conditions required by the Transaction Documents to be performed, satisfied or complied with by the Company
at or prior to the Commencement Date. The Buyer shall have received a certificate, executed by the CEO, President or CFO of the
Company, dated as of the Commencement Date, to the foregoing effect in the form attached hereto as Exhibit A;
(f) The Board of Directors of the Company or a duly authorized committee thereof shall have adopted resolutions substantially in the
form attached hereto as Exhibit B, which shall be in full force and effect without any amendment or supplement thereto as of the
Commencement Date;
(g) As of the Commencement Date, the Company shall have reserved out of its authorized and unissued Common Stock, solely for the
purpose of effecting future purchases of Purchase Shares hereunder, four million three hundred seventy-two
thousand three hundred seventy-three (4,372,373) shares of Common Stock;
(h) The Irrevocable Transfer Agent Instructions, in form acceptable to the Buyer shall have been delivered to and acknowledged in
writing by the Company and the Buyer and have been delivered to the Transfer Agent;
(i) The Company shall have delivered to the Buyer a certificate evidencing the incorporation and good standing of the Company in the
Commonwealth of Pennsylvania issued by the Secretary of Commonwealth of the Commonwealth of Pennsylvania as of a date within ten
(10) Business Days of the Commencement Date;
(j) [Intentionally Omitted];
(k) The Company shall have delivered to the Buyer a secretary’s certificate executed by the Secretary of the Company, dated as of the
Commencement Date, in the form attached hereto as Exhibit C;
(l) No stop order with respect to the Shelf Registration Statement shall be pending or threatened by the SEC. The Company shall have
prepared and delivered to the Buyer a final and complete form of prospectus supplement, dated and current as of the Commencement Date,
to be used in connection with any issuances of any Commitment Shares or any Purchase Shares to the Buyer, and to be filed by the
Company within two (2) Business Days after the Commencement Date pursuant to Rule 424(b). The Company shall have made all filings
under all applicable federal and state securities laws necessary to consummate the issuance of the Commitment Shares and the Purchase
Shares pursuant to this Agreement in compliance with such laws;
(m) No Event of Default has occurred and is continuing, or any event which, after notice and/or lapse of time, would become an Event
of Default has occurred;
(n) On or prior to the Commencement Date, the Company shall take all necessary action, if any, and such actions as reasonably
requested by the Buyer, in order to render inapplicable any control share acquisition, business combination, shareholder rights plan or
poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Articles of Incorporation
or the laws of the Commonwealth of Pennsylvania that is or could become applicable to the Buyer as a result of the transactions
contemplated by this Agreement, including, without limitation, the Company’s issuance of the Securities and the Buyer’s ownership of the
Securities; and
(o) The Company shall have provided the Buyer with the information reasonably requested by the Buyer in connection with its due
diligence requests made prior to, or in connection with, the Commencement, in accordance with the terms of Section 4(f) hereof.
8.
INDEMNIFICATION.
In consideration of the Buyer’s execution and delivery of the Transaction Documents and acquiring the Securities hereunder and in
addition to all of the Company’s other obligations under the Transaction Documents, the Company shall defend, protect, indemnify and
hold harmless the Buyer and all of its affiliates, members, officers, directors, and employees, and any of the foregoing person’s agents or
other representatives (including, without limitation, those retained in connection with the transactions contemplated by this Agreement)
(collectively, the “Indemnitees”) from and against any and all third party actions, causes of action, suits, claims, losses, costs, penalties,
fees, liabilities and damages, and expenses in connection therewith (irrespective of whether any such Indemnitee is a party to the action for
which indemnification hereunder is sought), and including reasonable attorneys’ fees and disbursements (the “Indemnified Liabilities”),
incurred by any Indemnitee as a result of, or arising out of, or relating to (a) any misrepresentation or breach of any representation or
warranty made by the Company in the Transaction Documents or any other certificate, instrument or document contemplated hereby or
thereby, (b) any breach of any covenant, agreement or obligation of the Company contained in the Transaction Documents or any other
certificate, instrument or document contemplated hereby or thereby, or (c) any cause of action, suit or claim brought or made against such
Indemnitee and arising out of or resulting from the execution, delivery, performance or enforcement of the Transaction Documents or any
other certificate, instrument or document contemplated hereby or thereby, other than with respect to Indemnified Liabilities which directly
and primarily result from (A) a breach of any of the Buyer’s representations and warranties, covenants or agreements contained in this
Agreement, or (B) the gross negligence, bad faith or willful misconduct of the Buyer or any other Indemnitee. To the extent that the
foregoing undertaking by the Company may be unenforceable for any reason, the Company shall make the maximum contribution to the
payment and satisfaction of each of the Indemnified Liabilities which is permissible under applicable law.
9.
EVENTS OF DEFAULT.
An “Event of Default” shall be deemed to have occurred at any time as any of the following events occurs:
(a) during any period in which the effectiveness of any registration statement is required to be maintained pursuant to the terms of the
Registration Rights Agreement, the effectiveness of such registration statement lapses for any reason (including, without limitation, the
issuance of a stop order) or is unavailable to the Company for sale of all of the Registrable Securities (as defined in the Registration Rights
Agreement) to the Buyer in accordance with the terms of the Registration Rights Agreement, and such lapse or unavailability continues for
a period of ten (10) consecutive Business Days or for more than an aggregate of thirty (30) Business Days in any 365-day period, which is
not in connection with a post-effective amendment to any such registration statement or the filing of a new registration statement; provided,
however, that in connection with any post-effective amendment to such registration statement or filing of a new registration statement that
is required to be declared effective by the SEC, such lapse or unavailability may continue for a period of no more than thirty (30)
consecutive Business Days, which such period shall be extended for an additional thirty (30) Business Days if the Company receives a
comment letter from the SEC in connection therewith;
(b) the suspension from trading or failure of the Common Stock to be listed on a Principal Market for a period of three (3) consecutive
Business Days;
(c) the delisting of the Common Stock from the Principal Market, and the Common Stock is not immediately thereafter trading on the
New York Stock Exchange, the NYSE American, the Nasdaq Global Select Market, the Nasdaq Global Market, or the Nasdaq Capital
Market;
(d) the failure for any reason by the Transfer Agent to issue Purchase Shares to the Buyer within five (5) Business Days after the
applicable Purchase Date that the Buyer is entitled to receive;
(e) the Company’s breach of any representation or warranty (as of the dates made), covenant or other term or condition under any
Transaction Document if such breach could reasonably be expected to have a Material Adverse Effect and except, in the case of a breach of
a covenant which is reasonably curable, only if such breach continues uncured for a period of at least five (5) Business Days;
(f) if any Person commences a proceeding against the Company pursuant to or within the meaning of any Bankruptcy Law;
(g) if the Company pursuant to or within the meaning of any Bankruptcy Law; (A) commences a voluntary case, (B) consents to the
entry of an order for relief against it in an involuntary case, (C) consents to the appointment of a Custodian of it or for all or substantially all
of its property, (D) makes a general assignment for the benefit of its creditors or (E) becomes insolvent;
(h) a court of competent jurisdiction enters an order or decree under any Bankruptcy Law that (A) is for relief against the Company in
an involuntary case, (B) appoints a Custodian of the Company or for all or substantially all of its property, or (C) orders the liquidation of
the Company or any Subsidiary; or
(i) if at any time after the Commencement Date, the Exchange Cap is reached unless and until shareholder approval is obtained
pursuant to Section 1(h) hereof. The Exchange Cap shall be deemed to be reached at such time if, upon submission of a Purchase Notice or
VWAP Purchase Notice under this Agreement, the issuance of such shares of Common Stock would exceed the number of shares of
Common Stock which the Company may issue under this Agreement without breaching the Company’s obligations under the rules or
regulations of the Principal Market.
In addition to any other rights and remedies under applicable law and this Agreement, including the Buyer termination rights under
Section 11(k) hereof, so long as an Event of Default has occurred and is continuing, or if any event which, after notice and/or lapse of time,
would become an Event of Default, has occurred and is continuing, or so long as the Closing Sale Price is below the Floor Price, the
Company may not require and the Buyer shall not be obligated to purchase any shares of Common Stock under this Agreement. If pursuant
to or within the meaning of any Bankruptcy Law, the Company commences a voluntary case or any Person commences a proceeding
against the Company, a Custodian is appointed for the Company or for all or substantially all of its property, or the Company makes a
general assignment for the benefit of its creditors, (any of which would be an Event of Default as described in Sections 9(f), 9(g) and 9(h)
hereof) this Agreement shall automatically terminate without any liability or payment to the Company without further action or notice by
any Person. No such termination of this Agreement under Section 11(k)(i) shall affect the Company’s or the Buyer’s obligations under this
Agreement with respect to pending purchases and the Company and the Buyer shall complete their respective obligations with respect to
any pending purchases under this Agreement.
10.
CERTAIN DEFINED TERMS.
For purposes of this Agreement, the following terms shall have the following meanings:
(a) “1933 Act” means the Securities Act of 1933, as amended.
(b) “Available Amount” means initially Twenty Million Dollars ($20,000,000) in the aggregate, which amount shall be reduced by
the Purchase Amount each time the Buyer purchases shares of Common Stock pursuant to Section 1 hereof.
(c) “Bankruptcy Law” means Title 11, U.S. Code, or any similar federal or state law for the relief of debtors.
(d) “Business Day” means any day on which the Principal Market is open for trading during normal trading hours (i.e., 9:30 a.m. to
4:00 p.m. Eastern Time), including any day on which the Principal Market is open for trading for a period of time less than the customary
time.
(e) “Closing Sale Price” means the last closing trade price for the Common Stock on the Principal Market as reported by the Principal
Market.
(f) “Confidential Information” means any information disclosed by either party to the other party, either directly or indirectly, in
writing, orally or by inspection of tangible objects (including, without limitation, documents, prototypes, samples, plant and equipment),
which is designated as “Confidential,” “Proprietary” or some similar designation. Information communicated orally shall be considered
Confidential Information if such information is confirmed in writing as being Confidential Information within ten (10) Business Days after
the initial disclosure. Confidential Information may also include information disclosed to a disclosing party by third parties. Confidential
Information shall not, however, include any information which (i) was publicly known and made generally available in the public domain
prior to the time of disclosure by the disclosing party; (ii) becomes publicly known and made generally available after disclosure by the
disclosing party to the receiving party through no action or inaction of the receiving party; (iii) is already in the possession of the receiving
party at the time of disclosure by the disclosing party as shown by the receiving party’s files and records immediately prior to the time of
disclosure; (iv) is obtained by the receiving party from a third party without a breach of such third party’s obligations of confidentiality; (v)
is independently developed by the receiving party without use of or reference to the disclosing party’s Confidential Information, as shown
by documents and other competent evidence in the receiving party’s possession; or (vi) is required by law to be disclosed by the receiving
party, provided that the receiving party gives the disclosing party prompt written notice of such requirement prior to such disclosure and
assistance in obtaining an order protecting the information from public disclosure.
(g) “Custodian” means any receiver, trustee, assignee, liquidator or similar official under any Bankruptcy Law.
(h) “Maturity Date” means the date that is thirty (30) months from the Commencement Date.
(i) “Person” means an individual or entity including any limited liability company, a partnership, a joint venture, a corporation, a trust,
an unincorporated organization and a government or any department or agency thereof.
(j) “Principal Market” means the Nasdaq Capital Market; provided however, that in the event the Company’s Common Stock is ever
listed or traded on the New York Stock Exchange, the NYSE American, the Nasdaq Global Select Market, the Nasdaq Global Market, or
the Nasdaq Capital Market, then the “Principal Market” shall mean such other market or exchange on which the Company’s Common
Stock is then listed or traded.
(k) “Purchase Amount” means, with respect to any particular purchase made hereunder, the portion of the Available Amount to be
purchased by the Buyer pursuant to Section 1 hereof as set forth in a valid Purchase Notice or VWAP Purchase Notice which the Company
delivers to the Buyer.
(l) “Purchase Date” means with respect to any Regular Purchase made hereunder, the Business Day of receipt by the Buyer of a valid
Purchase Notice that the Buyer is to buy Purchase Shares pursuant to Section 1(b) hereof.
(m) “Purchase Notice” shall mean an irrevocable written notice from the Company to the Buyer directing the Buyer to buy Purchase
Shares pursuant to Section 1(b) hereof as specified by the Company therein at the applicable Purchase Price on the Purchase Date.
(n) “Purchase Price” means the lesser of (i) the lowest Sale Price of the Common Stock on the Purchase Date or (ii) the arithmetic
average of the three (3) lowest Closing Sale Prices for the Common Stock during the ten (10) consecutive Business
Days ending on the Business Day immediately preceding such Purchase Date (to be appropriately adjusted for any reorganization,
recapitalization, stock dividend, stock split, reverse stock split or other similar transaction).
(o) “Sale Price” means any trade price for the shares of Common Stock on the Principal Market during normal trading hours, as
reported by the Principal Market.
(p) “SEC” means the United States Securities and Exchange Commission.
(q) “Transfer Agent” means the transfer agent of the Company as set forth in Section 11(f) hereof or such other person who is then
serving as the transfer agent for the Company in respect of the Common Stock.
(r) “VWAP Minimum Price Threshold” means, with respect to any particular VWAP Purchase Notice, the Sale Price on the VWAP
Purchase Date equal to the greater of (i) 80% of the Closing Sale Price on the Business Day immediately preceding the VWAP Purchase
Date or (ii) such higher price as set forth by the Company in the VWAP Purchase Notice.
(s) “VWAP Purchase Amount” means, with respect to any particular VWAP Purchase Notice, the portion of the Available Amount
to be purchased by the Buyer pursuant to Section 1(c) hereof pursuant to a valid VWAP Purchase Notice which requires the Buyer to buy
the VWAP Purchase Share Percentage of the aggregate shares traded on the Principal Market during normal trading hours on the VWAP
Purchase Date up to the VWAP Purchase Share Volume Maximum, subject to the VWAP Minimum Price Threshold.
(t) “VWAP Purchase Date” means, with respect to any VWAP Purchase made hereunder, the Business Day following the receipt by
the Buyer of a valid VWAP Purchase Notice that the Buyer is to buy Purchase Shares pursuant to Section 1(c) hereof.
(u) “VWAP Purchase Notice” shall mean an irrevocable written notice from the Company to the Buyer directing the Buyer to buy
Purchase Shares on the VWAP Purchase Date pursuant to Section 1(c) hereof as specified by the Company therein at the applicable VWAP
Purchase Price with the applicable VWAP Purchase Share Percentage specified therein.
(v) “VWAP Purchase Share Percentage” means, with respect to any particular VWAP Purchase Notice pursuant to Section 1(c)
hereof, the percentage set forth in the VWAP Purchase Notice which the Buyer will be required to buy as a specified percentage of the
aggregate shares traded on the Principal Market during normal trading hours up to the VWAP Purchase Share Volume Maximum on the
VWAP Purchase Date subject to Section 1(c) hereof but in no event shall this percentage exceed thirty percent (30%) of such VWAP
Purchase Date’s share trading volume of the Common Stock on the Principal Market during normal trading hours.
(w) “VWAP Purchase Price” means the lesser of (i) the Closing Sale Price on the VWAP Purchase Date; or (ii) ninety-seven percent
(97%) of volume weighted average price for the Common Stock traded on the Principal Market during normal trading hours on (A) the
VWAP Purchase Date if the aggregate shares traded on the Principal Market on the VWAP Purchase Date have not exceeded the VWAP
Purchase Share Volume Maximum and the Sale Price of Common Stock has not fallen below the VWAP Minimum Price Threshold (to be
appropriately adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction),
or (B) the portion of the VWAP Purchase Date until such time as the sooner to occur of (1) the time at which the aggregate shares traded
on the Principal Market has exceeded the VWAP Purchase Share Volume Maximum, or (2) the time at which the Sale Price of Common
Stock falls below the VWAP Minimum Price Threshold (to be appropriately adjusted for any reorganization, recapitalization, stock
dividend, stock split, reverse stock split or other similar transaction).
(x) “VWAP Purchase Share Estimate” means the number of shares of Common Stock that the Company has in its sole discretion
irrevocably instructed its Transfer Agent to issue to the Buyer via the Depository Trust Company (“DTC”) Fast Automated Securities
Transfer Program in connection with a VWAP Purchase Notice pursuant to Section 1(c) hereof and issued to the Buyer’s or its designee’s
balance account with DTC through its Deposit Withdrawal At Custodian (DWAC) system on the VWAP Purchase Date (to be
appropriately adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction).
(y) “VWAP Purchase Share Volume Maximum” means a number of shares of Common Stock traded on the Principal Market during
normal trading hours on the VWAP Purchase Date equal to: (i) the VWAP Purchase Share Estimate, divided by (ii) the VWAP Purchase
Share Percentage (to be appropriately adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or
other similar transaction).
11.
MISCELLANEOUS.
(a) Governing Law; Jurisdiction; Jury Trial. The corporate laws of the Commonwealth of Pennsylvania shall govern all issues
concerning the relative rights of the Company and its shareholders. All other questions concerning the construction, validity, enforcement
and interpretation of this Agreement and the other Transaction Documents shall be governed by the internal laws of the State of Illinois,
without giving effect to any choice of law or conflict of law provision or rule (whether of the State of Illinois or any other jurisdictions) that
would cause the application of the laws of any jurisdictions other than the State of Illinois. Each party hereby irrevocably submits to the
exclusive jurisdiction of the state and federal courts sitting in the City of Chicago, Illinois, for the adjudication of any dispute hereunder or
under the other Transaction Documents or in connection herewith or therewith, or with any transaction contemplated hereby or discussed
herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to
the jurisdiction of any such court, that such suit, action or proceeding is brought in an inconvenient forum or that the venue of such suit,
action or proceeding is improper. Each party hereby irrevocably waives personal service of process and consents to process being served in
any such suit, action or proceeding by mailing a copy thereof to such party at the address for such notices to it under this Agreement and
agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed
to limit in any way any right to serve process in any manner permitted by law. EACH PARTY HEREBY IRREVOCABLY WAIVES
ANY RIGHT IT MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY
DISPUTE HEREUNDER OR IN CONNECTION HEREWITH OR ARISING OUT OF THIS AGREEMENT OR ANY
TRANSACTION CONTEMPLATED HEREBY.
(b) Counterparts. This Agreement may be executed in two or more identical counterparts, all of which shall be considered one and the
same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party; provided
that a facsimile or pdf (or other electronic reproduction) signature shall be considered due execution and shall be binding upon the
signatory thereto with the same force and effect as if the signature were an original, not a facsimile or PDF (or other electronic
reproduction) signature.
(c) Headings. The headings of this Agreement are for convenience of reference and shall not form part of, or affect the interpretation
of, this Agreement.
(d) Severability. If any provision of this Agreement shall be invalid or unenforceable in any jurisdiction, such invalidity or
unenforceability shall not affect the validity or enforceability of the remainder of this Agreement in that jurisdiction or the validity or
enforceability of any provision of this Agreement in any other jurisdiction.
(e) Entire Agreement. This Agreement and the Registration Rights Agreement supersede all other prior oral or written agreements
between the Buyer, the Company, their affiliates and persons acting on their behalf with respect to the matters discussed herein, and this
Agreement, the other Transaction Documents and the instruments referenced herein contain the entire understanding of the parties with
respect to the matters covered herein and therein and, except as specifically set forth herein or therein, neither the Company nor the Buyer
makes any representation, warranty, covenant or undertaking with respect to such matters. Each of the Company and the Buyer
acknowledge and agree that it has not relied on, in any manner whatsoever, any representations or statements, written or oral, other than as
expressly set forth in this Agreement.
(f) Notices. Any notices, consents or other communications required or permitted to be given under the terms of this Agreement must
be in writing and will be deemed to have been delivered: (i) upon receipt when delivered personally; (ii) upon receipt when sent by
facsimile (provided confirmation of transmission is mechanically or electronically generated and kept on file by the sending party); (iii)
upon receipt, when sent by electronic message (provided the recipient responds to the message and confirmation of both electronic
messages are kept on file by the sending party); or (iv) one (1) Business Day after timely deposit with a nationally recognized overnight
delivery service, in each case properly addressed to the party to receive the same. The addresses and facsimile numbers for such
communications shall be:
If to the Company:
Recro Pharma, Inc.
490 Lapp Road
Malvern, PA 19355
Telephone: 484-395-2470
Facsimile: 484-395-2471
Attention: Michael Celano
Email: mcelano@recropharma.com
With a copy (which shall not constitute notice) to:
Pepper Hamilton LLP
3000 Two Logan Square
Eighteenth and Arch Streets
Philadelphia, PA 19103
Telephone: 215-981-4331
Facsimile: 215-981-4750
Attention: Rachael M. Bushey
Email: busheyr@pepperlaw.com
If to the Buyer:
Aspire Capital Fund, LLC
155 North Wacker Drive, Suite 1600
Chicago, IL 60606
Telephone: 312-658-0400
Facsimile: 312-658-4005
Attention: Steven G. Martin
Email: smartin@aspirecapital.com
With a copy to (which shall not constitute delivery to the Buyer):
Morrison & Foerster LLP
2000 Pennsylvania Avenue, NW, Suite 6000
Washington, DC 20006
Telephone: 202-778-1611
Facsimile: 202-887-0763
Attention: Martin P. Dunn, Esq.
Email: mdunn@mofo.com
If to the Transfer Agent:
Broadridge Corporate Issuer Solutions, Inc.
2 Journal Square, 7th Floor
Jersey City, NJ 07306
Telephone: 201-714-3800
Facsimile: 201-714-8862
Attention: Jennifer A. Whitney, Broadridge Relationship Manager
Email: Jennifer.Whitney@broadridge.com
or at such other address and/or facsimile number and/or to the attention of such other person as the recipient party has specified by written
notice given to each other party at least one (1) Business Day prior to the effectiveness of such change. Written confirmation of receipt (A)
given by the recipient of such notice, consent or other communication, (B) mechanically or electronically generated by the sender’s
facsimile machine containing the time, date, and recipient facsimile number, (C) electronically generated by the sender’s electronic mail
containing the time, date and recipient email address or (D) provided by a nationally recognized overnight delivery service, shall be
rebuttable evidence of receipt in accordance with clause (i), (ii), (iii) or (iv) above, respectively.
(g) Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their respective
successors and assigns. The Company shall not assign this Agreement or any rights or obligations hereunder without the prior written
consent of the Buyer, including by merger or consolidation; provided, however, that any transaction, whether by merger, reorganization,
restructuring, consolidation, financing or otherwise, whereby the Company remains the surviving entity immediately after such transaction
shall not be deemed a succession or assignment. The Buyer may not assign its rights or obligations under this Agreement.
(h) No Third Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective permitted
successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other person.
(i) Publicity. The Buyer shall have the right to approve before issuance any press release, SEC filing or any other public disclosure
made by or on behalf of the Company whatsoever with respect to, in any manner, the Buyer, its purchases hereunder or any aspect of this
Agreement or the transactions contemplated hereby; provided, however, that the Company shall be
entitled, without the prior approval of the Buyer, to make any press release or other public disclosure (including any filings with the SEC)
with respect to such transactions as is required by applicable law and regulations so long as the Company and its counsel consult with the
Buyer in connection with any such press release or other public disclosure at least one (1) Business Day prior to its release; provided,
however, that the Company’s obligations pursuant to this Section 11(i) shall not apply if the material provisions of such press release, SEC
filing, or other public disclosure previously has been publicly disclosed by the Company in accordance with this Section 11(i). The Buyer
must be provided with a copy thereof at least one (1) Business Day prior to any release or use by the Company thereof.
(j) Further Assurances. Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall
execute and deliver all such other agreements, certificates, instruments and documents, as the other party may reasonably request in order
to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.
(k) Termination. This Agreement may be terminated only as follows:
(i) By the Buyer any time an Event of Default exists without any liability or payment to the Company. However, if pursuant to or
within the meaning of any Bankruptcy Law, the Company commences a voluntary case or any Person commences a proceeding against
the Company, a Custodian is appointed for the Company or for all or substantially all of its property, or the Company makes a general
assignment for the benefit of its creditors, (any of which would be an Event of Default as described in Sections 9(f), 9(g) and 9(h)
hereof) this Agreement shall automatically terminate without any liability or payment to the Company without further action or notice
by any Person. No such termination of this Agreement under this Section 11(k)(i) shall affect the Company’s or the Buyer’s obligations
under this Agreement with respect to pending purchases and the Company and the Buyer shall complete their respective obligations with
respect to any pending purchases under this Agreement.
(ii) In the event that the Commencement shall not have occurred, the Company shall have the option to terminate this Agreement
for any reason or for no reason without any liability whatsoever of either party to the other party under this Agreement except as set
forth in Section 11(k)(viii) hereof.
(iii) In the event that the Commencement shall not have occurred within ten (10) Business Days, due to the failure to satisfy any of
the conditions set forth in Sections 6 and 7 above with respect to the Commencement, either party shall have the option to terminate this
Agreement at the close of business on such date or thereafter without liability of either party to any other party; provided, however, that
the right to terminate this Agreement under this Section 11(k)(iii) shall not be available to either party if such failure to satisfy any of the
conditions set forth in Sections 6 and 7 is the result of a breach of this Agreement by such party or the failure of any representation or
warranty of such party included in this Agreement to be true and correct in all material respects.
(iv) At any time after the Commencement Date, the Company shall have the option to terminate this Agreement for any reason or
for no reason by delivering notice (a “Company Termination Notice”) to the Buyer electing to terminate this Agreement without any
liability whatsoever of either party to the other party under this Agreement except as set forth in Section 11(k)(viii) hereof. The
Company Termination Notice shall not be effective until one (1) Business Day after it has been received by the Buyer.
(v) This Agreement shall automatically terminate on the date that the Company sells and the Buyer purchases the full Available
Amount as provided herein, without any action or notice on the part of any party and without any liability whatsoever of any party to
any other party under this Agreement except as set forth in Section 11(k)(viii) hereof.
(vi) If by the Maturity Date for any reason or for no reason the full Available Amount under this Agreement has not been purchased
as provided for in Section 1 of this Agreement, this Agreement shall automatically terminate on the Maturity Date, without any action or
notice on the part of any party and without any liability whatsoever of any party to any other party under this Agreement except as set
forth in Section 11(k)(viii) hereof.
(vii) Except as set forth in Sections 11(k)(i) (in respect of an Event of Default under Sections 9(f), 9(g) and 9(h)), 11(k)(v) and
11(k)(vi), any termination of this Agreement pursuant to this Section 11(k) shall be effected by written notice from the Company to the
Buyer, or the Buyer to the Company, as the case may be, setting forth the basis for the termination hereof.
(viii) The representations and warranties of the Company and the Buyer contained in Sections 2, 3 and 5 hereof, the
indemnification provisions set forth in Section 8 hereof and the agreements and covenants set forth in Sections 4(e) and 11, shall survive
the Commencement and any termination of this Agreement. No termination of this Agreement shall affect the Company’s or the Buyer’s
rights or obligations (A) under the Registration Rights Agreement, which shall survive any such termination in accordance with its
terms, or (B) under this Agreement with respect to pending purchases and the Company
and the Buyer shall complete their respective obligations with respect to any pending purchases under this Agreement.
(l) No Financial Advisor, Placement Agent, Broker or Finder. The Company represents and warrants to the Buyer that it has not
engaged any financial advisor, placement agent, broker or finder in connection with the transactions contemplated hereby. The Buyer
represents and warrants to the Company that it has not engaged any financial advisor, placement agent, broker or finder in connection with
the transactions contemplated hereby. Each party shall be responsible for the payment of any fees or commissions, if any, of any financial
advisor, placement agent, broker or finder engaged by such party relating to or arising out of the transactions contemplated hereby. Each
party shall pay, and hold the other party harmless against, any liability, loss or expense (including, without limitation, attorneys’ fees and
out of pocket expenses) arising in connection with any such claim.
(m) No Strict Construction. The language used in this Agreement will be deemed to be the language chosen by the parties to express
their mutual intent, and no rules of strict construction will be applied against any party.
(n) Failure or Indulgence Not Waiver. No failure or delay in the exercise of any power, right or privilege hereunder shall operate as a
waiver thereof, nor shall any single or partial exercise of any such power, right or privilege preclude other or further exercise thereof or of
any other right, power or privilege.
* * * * *
IN WITNESS WHEREOF, the Buyer and the Company have caused this Common Stock Purchase Agreement to be duly executed as
of the date first written above.
THE COMPANY:
RECRO PHARMA, INC.
/s/ Geraldine A. Henwood
By:
Name: Geraldine A. Henwood
Chief Executive Officer
Title:
BUYER:
ASPIRE CAPITAL FUND, LLC
BY:
BY:
ASPIRE CAPITAL PARTNERS, LLC
CHRISKO INVESTORS, INC
s/ Christos Komissopoulos
By:
Name: Christos Komissopoulos
Title:
President
EXHIBITS
Exhibit A
Exhibit B
Exhibit C
Form of Officer’s Certificate
Form of Resolutions of Board of Directors of the Company
Form of Secretary’s Certificate
EXHIBIT A
FORM OF OFFICER’S CERTIFICATE
This Officer’s Certificate (“Certificate”) is being delivered pursuant to Section 7(e) of that certain Common Stock Purchase
Agreement dated as of February 19, 2019 (the “Common Stock Purchase Agreement”), by and between RECRO PHARMA, a
Pennsylvania corporation (the “Company”), and ASPIRE CAPITAL FUND, LLC, an Illinois limited liability company (the “Buyer”).
Terms used herein and not otherwise defined shall have the meanings ascribed to them in the Common Stock Purchase Agreement.
The undersigned, , of the Company, hereby certifies as follows:
1. I am the of the Company and make the statements contained in this Certificate in my capacity as such;
2. The representations and warranties of the Company are true and correct in all material respects (except to the extent that any of
such representations and warranties is already qualified as to materiality in Section 3 of the Common Stock Purchase Agreement, in
which case, such representations and warranties are true and correct without further qualification) as of the date when made and as of
the Commencement Date as though made at that time (except for representations and warranties that speak as of a specific date);
3. The Company has performed, satisfied and complied in all material respects with covenants, agreements and conditions required
by the Transaction Documents to be performed, satisfied or complied with by the Company at or prior to the Commencement Date.
4. The Company has not taken any steps, and does not currently expect to take any steps, to seek protection pursuant to any
Bankruptcy Law nor does the Company or any of its Subsidiaries have any knowledge or reason to believe that its creditors intend to
initiate involuntary bankruptcy or insolvency proceedings. The Company is financially solvent and is generally able to pay its debts as
they become due.
IN WITNESS WHEREOF, I have hereunder signed my name on this day of February, 2019.
The undersigned as Secretary of RECRO PHARMA, INC., a Pennsylvania corporation, hereby certifies that _________ is the duly
elected, appointed, qualified and acting _________ of RECRO PHARMA, INC. and that the signature appearing above is his genuine
signature.
, Secretary
EXHIBIT B
FORM OF COMPANY RESOLUTIONS
FOR SIGNING PURCHASE AGREEMENT
WHEREAS, management has reviewed with the Board of Directors the background, terms and conditions of the transactions subject
to the Common Stock Purchase Agreement (the “Purchase Agreement”) by and between the Company and Aspire Capital Fund, LLC
(“Aspire”), including all materials terms and conditions of the transactions subject thereto, providing for the purchase by Aspire of up to
Twenty Million Dollars ($20,000,000) of the Company’s common stock, par value $0.01 per share (the “Common Stock”); and
WHEREAS, after careful consideration of the Purchase Agreement, the documents incident thereto and other factors deemed relevant
by the Board of Directors, the Board of Directors has determined that it is advisable and in the best interests of the Company to engage in
the transactions contemplated by the Purchase Agreement, including, but not limited to, the issuance of shares of Common Stock to Aspire
as a commitment fee (the “Commitment Shares”) and the sale of shares of Common Stock to Aspire up to the available amount under the
Purchase Agreement (the “Purchase Shares,” and together with the Commitment Shares, the “Aspire Shares”).
Transaction Documents
NOW, THEREFORE, BE IT RESOLVED, that the transactions described in the Purchase Agreement are hereby approved and the
Chief Executive Officer and Chief Financial Officer (the “Authorized Officers”) are severally authorized to execute and deliver the
Purchase Agreement, and any other agreements or documents contemplated thereby including, without limitation, a registration rights
agreement (the “Registration Rights Agreement”) providing for the registration of the shares of the Company’s Common Stock issuable
in respect of the Purchase Agreement on behalf of Aspire, with such amendments, changes, additions and deletions as the Authorized
Officers may deem to be appropriate and approve on behalf of, the Company, such approval to be conclusively evidenced by the signature
of an Authorized Officer thereon; and
FURTHER RESOLVED, that the terms and provisions of the Registration Rights Agreement by and among the Company and Aspire
are hereby approved and the Authorized Officers are authorized to execute and deliver the Registration Rights Agreement (pursuant to the
terms of the Purchase Agreement), with such amendments, changes, additions and deletions as the Authorized Officer may deem
appropriate and approve on behalf of, the Company, such approval to be conclusively evidenced by the signature of an Authorized Officer
thereon; and
FURTHER RESOLVED, that the terms and provisions of the Form of Transfer Agent Instructions (the “ Instructions”) are hereby
approved and the Authorized Officers are authorized to execute and deliver the Instructions (pursuant to the terms of the Purchase
Agreement), with such amendments, changes, additions and deletions as the Authorized Officers may deem appropriate and approve on
behalf of, the Company, such approval to be conclusively evidenced by the signature of an Authorized Officer thereon; and
FURTHER RESOLVED, that the Company be and it hereby is authorized to execute the Purchase Agreement providing for the
purchase of common stock of the Company having an aggregate value of up to $20,000,000; and
Execution of Purchase Agreement
Issuance of Common Stock
FURTHER RESOLVED, that the Company is hereby authorized to issue the Commitment Shares to Aspire as Commitment Shares
and that upon issuance of the Commitment Shares pursuant to the Purchase Agreement, the Commitment Shares shall be duly authorized,
validly issued, fully paid and non-assessable; and
FURTHER RESOLVED, that the Company is hereby authorized to issue shares of Common Stock upon the purchase of Purchase
Shares up to the available amount under the Purchase Agreement in accordance with the terms of the Purchase Agreement and that, upon
issuance of the Purchase Shares pursuant to the Purchase Agreement, the Purchase Shares will be duly authorized, validly issued, fully paid
and non-assessable; and
FURTHER RESOLVED, that the officers of the Company be, and each of them hereby is, authorized and directed, for and on behalf
of the Company, to execute and deliver one or more stock certificates representing any Aspire Shares sold under the Purchase Agreement in
such form as may be approved by such officers, or to cause any such Aspire Shares to be delivered through electronic book entry; and
Listing of Shares on the Nasdaq Capital Market
FURTHER RESOLVED, that the officers of the Company with the assistance of counsel be, and each of them hereby is, authorized
and directed to take all necessary steps and do all other things necessary and appropriate to effect the listing of the Aspire Shares on the
Nasdaq Capital Market; and
Approval of Actions
FURTHER RESOLVED, that, without limiting the foregoing, the Authorized Officers are, and each of them hereby is, authorized and
directed to proceed on behalf of the Company and to take all such steps as deemed necessary or appropriate, with the advice and assistance
of counsel, to cause the Company to consummate the agreements referred to herein and to perform its obligations under such agreements;
and
FURTHER RESOLVED, that the Authorized Officers be, and each of them hereby is, authorized, empowered and directed on behalf
of and in the name of the Company, to take or cause to be taken all such further actions and to execute and deliver or cause to be executed
and delivered all such further agreements, amendments, documents, certificates, reports, schedules, applications, notices, letters and
undertakings and to incur and pay all such fees and expenses as in their judgment shall be necessary, proper or desirable to carry into effect
the purpose and intent of any and all of the foregoing resolutions, and that all actions heretofore taken by any officer or director of the
Company in connection with the transactions contemplated by the agreements described herein are hereby approved, ratified and
confirmed in all respects.
EXHIBIT C
FORM OF SECRETARY’S CERTIFICATE
This Secretary’s Certificate (the “Certificate”) is being delivered pursuant to Section 7(k) of that certain Common Stock Purchase
Agreement dated as of February 19, 2019 (the “Common Stock Purchase Agreement”), by and between RECRO PHARMA, INC., a
Pennsylvania corporation (the “Company”) and ASPIRE CAPITAL FUND, LLC, an Illinois limited liability company (the “Buyer”),
pursuant to which the Company may sell to the Buyer up to Twenty Million Dollars ($20,000,000) of the Company’s Common Stock, par
value $0.01 (the “Common Stock”). Terms used herein and not otherwise defined shall have the meanings ascribed to them in the
Common Stock Purchase Agreement.
The undersigned, _________, Secretary of the Company, in his capacity as such, hereby certifies as follows:
1. I am the Secretary of the Company and make the statements contained in this Secretary’s Certificate.
2. Attached hereto as Exhibit A and Exhibit B are true, correct and complete copies of the Company’s Third Amended and Restated
Bylaws (“Bylaws”) and Second Amended and Restated Articles of Incorporation (“Articles”), in each case, as in effect through the date
hereof, and no action has been taken by the Company, its directors, officers or shareholders, in contemplation of the filing of any further
amendment relating to or affecting the Bylaws or Articles.
3. Attached hereto as Exhibit C are true, correct and complete copies of the resolutions duly adopted by the Board of Directors of
the Company on _________, 2019 at which a quorum was present and acting throughout. Such resolutions have not been amended,
modified or rescinded and remain in full force and effect and such resolutions are the only resolutions adopted by the Company’s Board
of Directors, or any committee thereof, or the shareholders of the Company relating to or affecting (i) the entering into and performance
of the Common Stock Purchase Agreement, or the issuance, offering and sale of the Purchase Shares and the Commitment Shares and
(ii) and the performance of the Company of its obligation under the Transaction Documents as contemplated therein.
4. As of the date hereof, the authorized, issued and reserved capital stock of the Company is as set forth on Exhibit D hereto.
IN WITNESS WHEREOF, I have hereunder signed my name on this _________ day of February, 2019.
The undersigned as the Chief Executive Officer of RECRO PHARMA, INC., a Pennsylvania corporation, hereby certifies that
_________ is the duly elected, appointed, qualified and acting Secretary of RECRO PHARMA, INC., and that the signature appearing
above is his genuine signature.
_________, Secretary
LIST OF SUBSIDIARIES
Exhibit 21.1
Subsidiary
Recro Gainesville LLC
Recro Gainesville Development LLC
Recro Enterprises, Inc.
Recro Ireland Limited
Ownership
Percentage
Jurisdiction of
Incorporation or
Organization
Massachusetts
100%
100% Delaware
Delaware
100%
Ireland
100%
Consent of Independent Registered Public Accounting Firm
Exhibit 23.1
The Board of Directors
Recro Pharma Inc.:
We consent to the incorporation by reference in the Registration Statements (No. 333-224870, 333-223437, 333-223436, 333-216581, 333-
216579, 333-208750, 333-208749, 333-206309, and 333-194730) on Form S-8, (No. 333-218487) on Form S-3, and (No. 333-201841) on
Form S-1 of Recro Pharma, Inc. of our report dated February 19, 2019, with respect to the consolidated balance sheets of Recro Pharma,
Inc. and subsidiaries as of December 31, 2018 and 2017, and the related consolidated statements of operations and comprehensive loss,
shareholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2018, and the related notes
(collectively, the consolidated financial statements), which report appears in the December 31, 2018 annual report on Form 10-K of Recro
Pharma, Inc.
/s/ KPMG LLP
Philadelphia, Pennsylvania
February 19, 2019
I, Gerri A. Henwood, certify that:
CERTIFICATION
Exhibit 31.1
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of Recro Pharma, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reports (as defined
in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
(a)
(b)
(c)
(d)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in
which this report is being prepared;
designed such internal control over financial reporting, or caused such internal control over financial reporting to
be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles;
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered
by this report based on such evaluation; and
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred
during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual
report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control
over financial reporting; and
5.
The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent function):
(a)
(b)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize
and report financial information; and
any fraud, whether or not material, that involves management or other employees who have a significant role in
the registrant’s internal control over financial reporting.
Date: February 19, 2019
/s/ Gerri A. Henwood
Gerri A. Henwood
President and Chief Executive Officer
(Principal Executive Officer)
I, Ryan D. Lake, certify that:
CERTIFICATION
Exhibit 31.2
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of Recro Pharma, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
(b)
(c)
(d)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in
which this report is being prepared;
designed such internal control over financial reporting, or caused such internal control over financial reporting to
be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles;
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered
by this report based on such evaluation; and
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred
during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual
report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control
over financial reporting; and
5.
The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent function):
(a)
(b)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize
and report financial information; and
any fraud, whether or not material, that involves management or other employees who have a significant role in
the registrant’s internal control over financial reporting.
Date: February 19, 2019
/s/ Ryan D. Lake
Ryan D. Lake
Chief Financial Officer
(Principal Finance and Accounting Officer)
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of Recro Pharma, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2018,
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company
certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to such officer’s
knowledge:
(1)
(2)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
Date: February 19, 2019
/s/ Gerri A. Henwood
Gerri A. Henwood
President and Chief Executive Officer
(Principal Executive Officer)
/s/ Ryan D. Lake
Ryan D. Lake
Chief Financial Officer
(Principal Financial Officer)