UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 11, 2016
Recro Pharma, Inc.
(Exact name of registrant as specified in its charter)
Pennsylvania | 001-36329 | 26-1523233 | ||
(State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
490 Lapp Road, Malvern, Pennsylvania | 19355 | |||
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (484) 395-2470
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition.
On August 11, 2016, Recro Pharma, Inc. (the Company) issued a press release announcing its financial results for the second quarter ended June 30, 2016. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth under Item 8.01 below is incorporated into this Item 2.02 by reference.
The information disclosed under Item 2.02, including Exhibits 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On August 12, 2016, the Company updated information reflected in a slide presentation, including certain financial information, which is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the updated presentation in various meetings with investors from time to time.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
Document | |
99.1 | Press release of Recro Pharma, Inc., dated August 11, 2016. | |
99.2 | Investor presentation of Recro Pharma, Inc. |
SIGNATURES
Pursuant to the requirements 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.
Recro Pharma, Inc. | ||
By: | /s/ Gerri A. Henwood | |
Name: | Gerri A. Henwood | |
Title: | Chief Executive Officer |
Date: August 12, 2016
EXHIBIT INDEX
Exhibit |
Document | |
99.1 | Press release of Recro Pharma, Inc., dated August 11, 2016. | |
99.2 | Investor presentation of Recro Pharma, Inc. |
Exhibit 99.1
Recro Pharma Reports Second Quarter 2016 Financial Results
Announced Positive Top-line Results from Pivotal Phase III Trial of
IV Meloxicam Following Bunionectomy Surgery
Pivotal Phase III Trial of IV Meloxicam in Abdominoplasty Ongoing with Top-line Data Expected by the End of 2016
Manufacturing Business Continues Solid Performance
MALVERN, PA, August 11, 2016 Recro Pharma, Inc. (Nasdaq: REPH), a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings, currently developing non-opioid products for the treatment of serious acute pain, today reported financial results for the second quarter ended June 30, 2016.
We had a strong first half of 2016, highlighted by positive top-line results recently reported from one of our pivotal Phase III trials of intravenous (IV) meloxicam for acute postoperative pain in patients following bunionectomy surgery, said Gerri Henwood, President and Chief Executive Officer of Recro Pharma. In addition to achieving its primary endpoint, which was a statistically significant reduction in SPID over the first 48 hours versus placebo, IV meloxicam also achieved fifteen of nineteen secondary endpoints, suggesting potential for the broad clinical utility of this promising candidate in a post-operative setting. There exists an urgent and growing need for non-opioid alternatives to address moderate-to-severe pain, and we look forward to reporting top-line results from our second pivotal study of IV meloxicam in mini abdominoplasty surgery by the end of 2016. Meloxicam represents a significant near-term commercial opportunity for our Company, and assuming positive data from our second pivotal study, we anticipate filing an NDA mid-summer 2017.
Second Quarter 2016 and Recent Highlights
| Reported Positive Top-line Phase III Results from First of Two Pivotal Intravenous (IV) Meloxicam Trials. In July 2016, Recro reported positive results from its Phase III clinical trial evaluating IV meloxicam for the treatment of acute postoperative pain in patients following bunionectomy surgery. In the trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 48 hours (SPID48) compared to placebo. The study also achieved fifteen of nineteen secondary endpoints, including statistically significant differences in SPID6, SPID12, SPID24, SPID24-48, time to first use of rescue medication, and several other rescue use and pain relief metrics during the first 48 hours, compared to placebo. |
| Ongoing Execution of Pivotal Phase III Trial of IV Meloxicam in Abdominoplasty. Enrollment continues in Recros second pivotal Phase III clinical trial evaluating IV meloxicam for acute postoperative pain in patients following mini abdominoplasty surgery. |
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The Company remains on track to report top-line results by the end of 2016. Assuming positive results from this second Phase III trial, the Company plans to file a New Drug Application for IV meloxicam in mid-summer 2017. |
| Manufacturing Business Continues Solid Performance. Our manufacturing business performed well with revenues of $35 million for the six months ended June 30, 2016, generating positive cash flow for the Company. We continue to expect 2016 revenues of $55 million to $60 million, given the timing of customer ordering patterns. |
| Strengthened Management Team with the Appointment of Michael Celano as Chief Financial Officer. Mr. Celano brings more than 35 years of financial leadership experience in the life sciences and biopharmaceutical industries to Recro, including serving in executive roles at Kensey Nash, BioRexis, and DrugScan. |
Financial Results
As of June 30, 2016, Recro Pharma had cash and cash equivalents of $14.8 million.
Pursuant to the terms of the Companys credit agreement with OrbiMed, OrbiMed has the option to require the Company to pay down debt with excess free cash flow generated from the Recro Gainesville manufacturing business. The Company made principal payments of approximately $2.6 million to OrbiMed during the six months ended June 30, 2016. Since its acquisition in April 2015 of the manufacturing business, the Company has paid down approximately $19.0 million, or 38%, of the original $50.0 million of senior secured term loan from the businesss excess cash flow generated. In August 2016, we will make an additional payment of $3.7 million which was 50% of the excess cash flow generated during the second quarter of 2016.
For the three months ended June 30, 2016, Recro Pharma reported a net loss applicable to common shareholders of $7.9 million, or $0.83 per share, compared to a net loss applicable to common shareholders of $1.3 million, or $0.17 per share, for the comparable period in 2015. For the six months ended June 30, 2016, Recro Pharma reported a net loss applicable to common shareholders of $14.4 million, or $1.53 per share, compared to a net loss applicable to common shareholders of $5.5 million, or $0.70 per share, for the comparable period in 2015.
Revenues for the three months ended June 30, 2016 were $17.3 million, compared to $18.7 million for the same period in 2015. The decrease in revenues is a result of the completion of research and development projects in 2015. COGS for the three months ended June 30, 2016 were $9.5 million, compared to $9.4 million for the same period in 2015.
Revenues and COGS for the six months ended June 30, 2016 were $35.0 million and $19.8 million, respectively, were higher than revenues and COGS of $18.7 million and $9.4 million, respectively, for the comparable period in 2015, as we owned the manufacturing business for three months in 2015 compared to six months in 2016.
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Research and development expenses for the three months ended June 30, 2016 were $8.3 million, compared to $2.8 million for the same period in 2015. Research and development expenses for the six months ended June 30, 2016 were $16.1 million, compared to $4.6 million for the same period in 2015. The increases in research and development expenses were primarily due to the Companys injectable meloxicam Phase III trials clinical expenses as well as increased research and development costs incurred at the Recro Gainesville facility, offset by a decrease in Dex clinical expenses.
General and administrative expenses for the three months ended June 30, 2016 were $2.8 million, compared to $2.6 million for the same period in 2015. General and administrative expenses for the six months ended June 30, 2016 were $5.4 million, compared to $5.0 million for the same period in 2015. The increases in general and administrative expenses were primarily due to an increase in salaries, benefits and stock compensation as a result of additional headcount.
Amortization of intangibles for the three months ended June 30, 2016 were $0.6 million, compared to $0.6 million for the same period in 2015. Amortization of intangibles for the six months ended June 30, 2016 were $1.3 million, compared to $0.6 million for the same period in 2015, as we owned the manufacturing business for three months in 2015 compared to six months in 2016.
Interest expense was $1.3 million for the three months ended June 30, 2016, compared to $1.7 million for the same period in 2015. Interest expense for the six months ended June 30, 2016 were $2.8 million, compared to $1.7 million for the same period in 2015, as we owned the manufacturing business for three months in 2015 compared to six months in 2016. Interest expense consists of interest incurred on our OrbiMed senior secured term loan used to purchase the manufacturing business and amortization of related financing costs.
About IV/IM Meloxicam
Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses anti-inflammatory, analgesic, and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. Meloxicam has been marketed by Boehringer Ingelheim Pharmaceuticals, Inc. since the 1990s as an oral agent, Mobic®. IV/IM meloxicam was designed using NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. Recro acquired IV/IM meloxicam from Alkermes in April 2015.
About Recro Pharma, Inc.
Recro Pharma is a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings and is currently developing non-opioid products for the treatment of serious acute pain. Recro Pharma is currently developing IV meloxicam, a proprietary, long-acting preferential COX-2 inhibitor for treatment of acute postoperative pain, which has completed four successful Phase II clinical trials in postoperative pain conditions and
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has reported positive results from its first pivotal Phase III clinical trial in patients following bunionectomy surgery. An additional development candidate, Dex-IN, a proprietary intranasal formulation of dexmedetomidine, is being pursued for the treatment of peri-procedural pain, and has had a past successful Phase II trial in bunionectomy. As Recro Pharmas product candidates are not in the opioid class of drugs, the Company believes its candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory distress, while maintaining analgesic effect.
Recro Pharma also owns and operates a 97,000 square foot, DEA-licensed facility that manufactures five commercial products and receives manufacturing revenues and royalties associated with the sales of these products.
Cautionary Statement Regarding Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Companys strategy, future operations, clinical development plans and other statements containing the words anticipate, believe, estimate, upcoming, plan, target, intend, expect and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: results and timing of the clinical trials of injectable meloxicam and Dex-IN; unfavorable new clinical data and additional analyses of existing clinical data; whether results of early clinical trials will be indicative of the results of future trials and whether interim results from a clinical trial will be predictive of the final results of the trial; the ability to obtain and maintain regulatory approval of injectable meloxicam and Dex-IN, and the labeling under any such approval; regulatory developments in the United States and foreign countries; the Companys ability to raise future financing for continued development; the Companys ability to pay its debt; the performance of third-party suppliers and manufacturers; the Companys ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection; the successful commercialization of injectable meloxicam and Dex-IN and other factors discussed in the Risk Factors set forth in the Companys Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Companys views only as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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CONTACT:
Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com
Investor Relations Contact:
Argot Partners
Susan Kim
(212) 600-1902
susan@argotpartners.com
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RECRO PHARMA, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(unaudited)
(amounts in thousands, except share and per share data) | ||||||||
June 30, 2016 | December 31, 2015 | |||||||
Assets | ||||||||
Current assets: |
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Cash and cash equivalents |
$ | 14,845 | $ | 19,779 | ||||
Accounts receivable |
11,480 | 8,580 | ||||||
Other receivables |
23 | 36 | ||||||
Inventory |
6,728 | 8,982 | ||||||
Prepaid expenses |
1,855 | 757 | ||||||
Deferred equity costs |
316 | 542 | ||||||
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Total current assets |
35,247 | 38,676 | ||||||
Property, plant and equipment, net |
36,621 | 37,922 | ||||||
Deferred income taxes |
16,644 | 15,637 | ||||||
Intangible assets, net |
38,725 | 40,016 | ||||||
Goodwill |
6,446 | 6,446 | ||||||
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Total assets |
$ | 133,683 | $ | 138,697 | ||||
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Liabilities and Shareholders Equity | ||||||||
Current liabilities: |
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Accounts payable |
$ | 1,752 | $ | 1,553 | ||||
Accrued expenses |
5,274 | 3,418 | ||||||
Current portion of long-term debt |
5,351 | 4,516 | ||||||
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Total current liabilities |
12,377 | 9,487 | ||||||
Long-term debt |
22,225 | 25,244 | ||||||
Warrants |
3,416 | 3,770 | ||||||
Contingent consideration |
64,358 | 59,846 | ||||||
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Total liabilities |
102,376 | 98,347 | ||||||
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Shareholders equity: |
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Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and outstanding. |
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Common stock, $0.01 par value. Authorized, 50,000,000 shares, issued and outstanding, 9,868,255 shares at June 30, 2016 and 9,224,315 shares at December 31, 2015 |
99 | 92 | ||||||
Additional paid-in capital |
76,695 | 71,321 | ||||||
Accumulated deficit |
(45,487 | ) | (31,063 | ) | ||||
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Total shareholders equity |
31,307 | 40,350 | ||||||
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Total liabilities and shareholders equity |
$ | 133,683 | $ | 138,697 | ||||
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RECRO PHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(unaudited)
(amounts in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Revenue: |
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Manufacturing, royalty and profit sharing revenue |
$ | 16,933 | $ | 16,704 | $ | 34,072 | $ | 16,704 | ||||||||
Research and development revenue |
346 | 1,956 | 949 | 1,956 | ||||||||||||
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Total revenue |
17,279 | 18,660 | 35,021 | 18,660 | ||||||||||||
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Operating expenses: |
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Cost of sales (excluding amortization of intangible assets) |
9,547 | 9,395 | 19,818 | 9,395 | ||||||||||||
Research and development |
8,320 | 2,821 | 16,129 | 4,575 | ||||||||||||
General and administrative |
2,763 | 2,597 | 5,421 | 4,986 | ||||||||||||
Amortization of intangible assets |
646 | 592 | 1,291 | 592 | ||||||||||||
Change in warrant valuation |
1,240 | 882 | (354 | ) | 882 | |||||||||||
Change in contingent consideration valuation |
1,534 | 2,000 | 4,512 | 2,000 | ||||||||||||
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Total operating expenses |
24,050 | 18,287 | 46,817 | 22,430 | ||||||||||||
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Operating income (loss) |
(6,771 | ) | 373 | (11,796 | ) | (3,770 | ) | |||||||||
Other income (expense): |
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Interest income |
8 | 4 | 17 | 8 | ||||||||||||
Interest expense |
(1,317 | ) | (1,688 | ) | (2,829 | ) | (1,688 | ) | ||||||||
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Net loss before income taxes |
(8,080 | ) | $ | (1,311 | ) | (14,608 | ) | (5,450 | ) | |||||||
Income tax benefit |
195 | 184 | ||||||||||||||
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Net loss applicable to common shareholders |
$ | (7,885 | ) | $ | (1,311 | ) | (14,424 | ) | (5,450 | ) | ||||||
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Basic and diluted net loss per common share |
$ | (0.83 | ) | $ | (0.17 | ) | $ | (1.53 | ) | $ | (0.70 | ) | ||||
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Weighted average basic and diluted common shares outstanding |
9,544,629 | 7,829,536 | 9,398,288 | 7,799,282 | ||||||||||||
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AUGUST 2016 Relieving pain…….Improving lives Exhibit 99.2
Special Note Regarding Forward-Looking Statements This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, relate to our business strategy, goals and expectations concerning our product candidates, future operations, prospects, plans and objectives of management. The words "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan", "predict", "project", "will" and similar terms and phrases are used to identify forward-looking statements in this presentation. Our operations involve risks and uncertainties, including the integration of our recently acquired assets, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
Company Highlights Multiple non-opioid therapeutics in advanced clinical development for pain conditions Progressing Phase III clinical trials for IV Meloxicam Reported positive top-line results for pivotal Phase III trial in patients following bunionectomy surgery Enrollment continues in second pivotal trial in patients following mini abdominoplasty surgery. On track to report top-line results by end of 2016 Enrolling safety study of 700 patients Assuming positive results from the clinical trials, plan to file a New Drug Application for IV Meloxicam approximately mid-summer 2017 Dex-IN – proprietary, intranasal therapeutic pursuing peri-procedural pain with eventual further Phase II work Revenue and cash flow positive manufacturing business Experienced management team with significant development, regulatory and commercial experience
Experienced Management and Board Gerri Henwood – President and CEO Founded Auxilium Pharmaceuticals (AUXL, NASDAQ) and IBAH (former NASDAQ Co. – acquired 1998); GSK Michael Celano – CFO Over 35 years of financial leadership experience – Kensey Nash, BioRexis, Orasure, Arthur Andersen/KPMG Randy Mack – SVP, Development Over 20 years of clinical development experience – Adolor, Auxilium, Abbott Labs and Harris Labs Stewart McCallum, MD – CMO Over 9 years of GSK Clinical experience – Development experience; past clinical Investigator, KOL and Stanford U. Fred Graff – CCO Over 20 years of successful commercial experience, including sales and marketing leadership roles at Sepracor, RPR, and MAP Pharmaceuticals Board of Directors Wayne B. Weisman – Chairman SCP VitaLife Partners Alfred Altomari CEO, Agile Therapeutics William L. Ashton Harrison Consulting Group; frmly Amgen Michael Berelowitz, M.D. Former SVP, Specialty Care Business Unit, Pfizer Winston J. Churchill SCP VitaLife Partners Gerri Henwood – CEO Abraham Ludomirski, M.D. SCP VitaLife Partners Karen Flynn President-Pharmaceutical Packaging Systems, West Pharmaceutical Services, Inc.
2015 Transformative Transaction Acquired IV/IM Meloxicam and manufacturing business from Alkermes in April 2015 $50M up-front cash payment plus working capital adjustment; Meloxicam milestones up to $120 million (including $10 million payable upon NDA filing and $30 million upon regulatory approval, and other revenue target milestones), and royalties Warrants issued to Alkermes and OrbiMed Non-dilutive up-front financed by loan from OrbiMed Paid down $22.7 million (including $3.7 million paid in August), or 45% of the original $50.0 million term loan from excess cash flow generated by the manufacturing business IV/IM Meloxicam – rapid onset, long acting preferential COX-2 inhibitor for moderate to severe acute pain Widely prescribed, approved oral chronic pain therapeutic Multiple Phase II studies successfully completed in acute pain models (outcomes in soft tissue and hard tissue models) Phase III pivotal trial in hard tissue model reported positive efficacy data in July 2016 Second Phase III efficacy trial ongoing, slated to report in 4Q16 Phase III Safety Study (700 patients) Dosing advantages over existing acute pain therapeutics, including longer duration of action Manufacturing business 97,000 sq. ft. facility (DEA licensed) manufactures 5 commercial products marketed by partners Revenues include product sales, royalties and profit sharing Expect 2016 revenues of $55M to $60M, and significant positive cash flow
Clinical Stage Pipeline Product PC I II III Rights Meloxicam WW IV formulation Acute post operative pain Phase III IM formulation Acute pain Dexmedetomidine (“Dex”) WW, exc. Europe, Turkey, CIS Dex-IN (intranasal) Peri-procedural pain Phase II Cancer breakthrough pain Dex-SL (sublingual) Fadolmidine (“Fado”) WW, exc. Europe, Turkey, CIS Intrathecal Topical
Post Op Pain Market Underserved $5.9 billion market(1) Predominantly opioid use Significant side effects / issues associated with opioids Dearth of non-opioid drugs in development Inpatient procedures Total procedures (2009) 47.9M Addressable >25M Ambulatory procedures Total procedures (2006) 53.3M Addressable >25M Note: Addressable includes procedures expected to utilize pain medication. Source: National Center for Health Statistics and management estimates. (1) GBI Research, 2010 sales.
Limited Pain Relief Options for Patients Note: Pain severity based upon market research / physician feedback Pain Severity Class Compounds Advantages Disadvantages Mild Acetaminophen Antipyretic properties; Oral; no opioid AEs Only effective for mild pain; short acting NSAIDs Ketorolac, ibuprofen, aspirin Mild to moderate analgesia; oral; no opioid AEs Bleeding risk; GI and renal complications; short acting Moderate Sodium channel blockers Bupivacaine, lidocaine Use directly at pain site; mostly peri-operative Limited duration of action; some are concerned about local tissue impact Alpha 2 agonists Dexmedetomidine (Recro Pharma) Good pain relief; anxiolytic properties; no respiratory depression, impaired GI or addictive properties In development – potential for first in class to be approved for peri-procedural pain Moderate to Severe Long-acting preferential COX-2 IV/IM meloxicam (Recro Pharma) Long acting; fast onset, high pain relief, and less constipation Bleeding risk; GI and renal complications Opioids Morphine, hydrocodone, oxycodone, fentanyl Good pain relief Respiratory depression, impaired GI motility after even one dose; frequent nausea and vomiting; abuse/addiction potential
IV/IM Meloxicam
IV/IM Meloxicam Overview FDA approved, oral preferential COX-2 inhibitor used in a wide variety of indications Proprietary long acting injectable form for moderate to severe acute pain Incorporates Alkermes’ NanoCrystalTM technology IV/IM Meloxicam – long acting preferential COX-2 inhibitor for moderate to severe acute pain Positive Phase III efficacy trial in bunionectomy Phase III efficacy trial in mini abdominoplasty ongoing (on track for top line results Q 4 ‘16) Phase III Safety study ongoing Positive Phase II Trials in soft and hard tissue Assuming positive results from the clinical trials, plan to file a New Drug Application for IV Meloxicam approximately mid-summer 2017 Formulation IP issued through 2022 and additional methods of preparation IP issued through May 2030 NanoCrystal® is a registered trademark of Alkermes plc.
Favorable Dosing Profile Attribute Meloxicam Ketorolac Caldolor (ibuprofen) Ofirmev (APAP) Route IV/IM IV/IM IV IV Onset of pain relief < 10 min 30 min N/A N/A Time to peak analgesic effect 40 min 1-2 hrs N/A N/A Duration of pain relief 18-24 hrs 4-6 hrs 4-6 hrs 4-6 hrs Admin. IV bolus and eventual pre-filled syringe Ready to use IV Dilution required, 30 min infusion Ready to use, 15 min infusion
Phase III Acute Postoperative Pain Studies Reported positive Phase III efficacy data in bunionectomy surgery trial, the first of two pivotal trials Placebo vs IV Meloxicam (30mg) every 24 hours Achieved statistical significance in primary endpoint (SPID48), as well as in 15 of 19 secondary endpoints Standard analgesia study design Progressing with second Phase III trial in acute postoperative pain following abdominoplasty surgery SPID24 = Primary Endpoint Currently enrolling Phase III 700 patient safety study
Study REC-15-016 Phase III Bunionectomy Multicenter, Multi-dose, Randomized, Double-blind, Placebo-controlled 201 subjects randomized to either IV Meloxicam (N1539) 30 mg or Placebo Study medication administered q24 hours up to 3 doses 95% of subjects completed the 48 hour assessments Standard analgesia design Pain Intensity assessments (SPID48 = Primary Endpoint) Use of rescue medication Time to onset Patient Global Assessment of Pain Control
Study REC-15-016 - Bunionectomy Primary Endpoint – SPID48 p = 0.0034
Study REC-15-016 - Bunionectomy Summary of Secondary Endpoints Parameter p-value SPID6 0.0153 SPID12 0.0053 SPID24 0.0084 SPID24-48 0.0050 Time to First Rescue Analgesia 0.0076 Number of Subjects Rescued 0-24 Hours 0.0002 Number of Subjects Rescued 24-48 Hours 0.0009 Number of Subjects Rescued 0-48 Hours 0.0002 Number of Times Rescued 0-24 Hours 0.0025 Number of Times Rescued 24-48 Hours 0.0108 Number of Times Rescued 0-48 Hours 0.0014 % Subjects with >30% Improvement - 6 Hours 0.0451 % Subjects with >30% Improvement - 24 Hours 0.0107 % Subjects with >50% Improvement - 24 Hours 0.0430 PGA of Pain Control at 48 hours 0.0046 Times to Perceptible and Meaningful Pain Relief, % Subjects with >50% Improvement within 6 Hours, PGA of Pain Control at 24 hours were not significantly different between treatment groups.
Study REC-15-016 - Bunionectomy Adverse Events – ≥3% in either group n (%) of Subjects N1539 30 mg Placebo Preferred Term (N=100) (N=101) Subjects with ≥ 1 TEAE 44 (44.0) 54 (53.5) Nausea 20 (20.0) 26 (25.7) Headache 8 (8.0) 12 (11.9) Vomiting 3 (3.0) 9 (8.9) Pruritus 8 (8.0) 3 (3.0) Decreased appetite 2 (2.0) 7 (6.9) Constipation 4 (4.0) 5 (5.0) Abdominal pain -- 6 (5.9) Dizziness 3 (3.0) 4 (4.0) Flushing 3 (3.0) 1 (1.0) Somnolence 3 (3.0) 2 (2.0) ALT increased -- 3 (3.0) **Two (2) subjects experienced Serious Adverse Events during this study. Both subjects were randomized to placebo.
Next Steps for IV Meloxicam Complete Phase III Pivotal Study in soft tissue model Top-line results expected in Q4 2016 Complete safety studies to meet adequate exposures / special populations Currently enrolling Total across all Phase III studies: est. 1,100 patients expected to be enrolled
Multiple Successful IV Phase 2 Trials Trial Design Outcome Phase II Study N1539-02 Acute pain following dental surgery (N = 230) Statistically significant differences for meloxicam doses compared to placebo were seen in SPID24, pain relief and onset of pain relief Phase II Study N1539-04 Acute pain following open abdominal hysterectomy surgery (N = 486) Statistically significant differences for meloxicam doses compared to placebo were seen in multiple efficacy analyses, including SPID24. meloxicam 30 mg and 60 mg produced the greatest response with no difference between doses Phase II Study N1539-05 Acute pain following laparoscopic abdominal surgery (N =50) Study stopped early (planned N = 250) for business reasons. However, statistically significant differences in SPID48 observed for 30mg QD dose despite small sample size Phase II Study -014 Safety, Efficacy and PK in Post-op bunionectomy (N=59) Safety-well tolerated, no serious AEs, no bleeding events Efficacy-Statistically significantly reductions in pain intensity as measured by SPID48 for 30 and 60 mg QD vs placebo
Study REC-15-014 SPID48 – WLOCF p = 0.0007 p = 0.0027
Study REC-15-014 Adverse Events – ≥2 Events Reported n (%) of Subjects N1539 60 mg N1539 30 mg Placebo Preferred Term (N=20) (N=20) (N=19) Nausea 4 (20.0) 6 (30.0) 4 (21.1) Headache 3 (15.0) 2 (10.0) 4 (21.1) Dizziness 2 (10.0) 3 (15.0) 1 (5.3) Pruritus 2 (10.0) 1 (5.0) 0 Vomiting 0 3 (15.0) 1 (5.3) Decreased appetite 1 (5.0) 0 2 (10.5) Erythema 0 2 (10.0) 1 (5.3) Constipation 1 (5.0) 1 (5.0) 0 GGT increased 0 0 2 (10.5) Muscle spasms 0 2 (10.0) 0 Somnolence 1 (5.0) 1 (5.0) 0
Phase II Abdominal Hysterectomy Study Multicenter, single-dose, randomized, double-blind, placebo- & active-controlled study in Eastern Europe In double-blind period, single doses of: All patients received placebo, IV Morphine (10-15 mg), Meloxicam 5 mg, 7.5 mg, 15 mg, 30 mg, 60 mg After 24 hours, open-label Meloxicam was available Standard analgesia study design Pain Intensity assessments (SPID24 = Primary Endpoint) Pain Relief Rescue medication Time to onset
Robust Efficacy (Abdominal Hysterectomy Trial – IV Meloxicam) *** p < 0.001 vs. Placebo *** *** *** *** *** ***
Confirmed Efficacy in Multiple Studies Summary of Pain Intensity Differences (SPID) *** p < 0.001 vs. Placebo *** *** *** *** Dental Pain Study p = 0.0682 p = 0.0392 Abdominal Laparoscopic Pain Study
Single 30 mg Dose Performance over 24 hrs (Abdominal Hysterectomy Trial – IV Meloxicam) Baseline Pain Level ≈ 60
Well Tolerated (Abdominal Hysterectomy Trial – IV Meloxicam) **Reported in ≥ 3% of Subjects in any group and greater than Placebo Meloxicam Placebo n=64 Morphine n=62 5 mg n=60 7.5 mg n=91 15 mg n=60 30 mg n=60 60 mg n=89 Anemia 3.1 4.8 3.3 13.2 3.3 1.7 10.1 Anemia Postoperative - 1.6 - - - 3.3 - Constipation - 4.8 5.0 1.1 1.7 - - Flatulence - 4.8 1.7 1.1 3.3 - - Hypokalemia - 3.2 1.7 1.1 - 1.7 - Insomnia 4.7 8.1 10.0 4.4 5.0 5.0 4.5 Ketonuria 7.8 9.7 6.7 9.9 15 10 10.1 Leukocytosis - - 1.7 - - 3.3 - Pyrexia 1.6 3.2 3.3 2.2 - - - Sinus Tachycardia - - 3.3 - - - 1.1 Percent of Subjects Reporting an Adverse Event **
Dexmedetomidine (“Dex”)
Dex Has Demonstrated Analgesia & Safety Alpha 2 agonist (non-opioid) Injectable form (Precedex) marketed by Hospira in US as sedative Multiple studies demonstrating analgesia of alpha 2 agonists Intranasal formulation in clinical development for peri-procedural pain In-licensed non-IV rights from Orion Worldwide rights except Europe, Turkey, and CIS Multiple studies demonstrate Dex pain relief and safety profile Including our completed placebo controlled trials Expect strong IP position Pending IP coverage could run through 2030 Expect to file 505(b)(2) NDA after completion of Ph III
Positive Dex-IN Ph II Results (REC-14-013 – Post Op Day 1 Dosing) Randomized, placebo controlled Phase II bunionectomy study (168 patients) Randomized, placebo controlled study 50 mcg of Dex-IN or placebo every 6 hours Primary endpoint – SPID48 (p=0.0214) Oral opioid rescue therapy allowed 6 patients discontinued for lack of efficacy (3 in each treatment group) and 1 patient due to serious adverse event of hypotension Most common adverse events observed in the study were: blood pressure decrease / hypotension nausea (similar incidences to placebo) nasal discomfort and headache Adverse event of bradycardia was reported in 3 subjects in the Dex-IN treatment group
Significant Advantages Over Opioids Meloxicam/Dex Fast-acting Opioids Non-opioid (Not controlled substance) Opioid - DEA scheduled product No habituation effects Addictive Does not cause respiratory depression Respiratory depression Not associated with notable constipation, nausea, or vomiting Unwanted side-effects of constipation, nausea and vomiting DEX: Enhances morphine effectiveness without morphine dose increase Additive effect requires higher dose Dex: Anxiolytic properties Not anxiolytic Meloxicam: Highly Effective Analgesic Effective Analgesic
Dex Has Been Well Studied by Recro Evaluated proprietary formulations of Dex in 10 trials Trial Form Design Outcome REC-14-013 Dex-IN Acute pain following bunionectomy surgery (n=168) Statistically significant difference of SPID48 between 50 mcg of Dex-IN vs. placebo (p=0.0214) REC-13-012 Dex-IN Acute pain following bunionectomy surgery (n=85 evaluable) Within subset of patients (n=42), with baseline pain intensity of 6 or below, there was a trend towards analgesia in 50 mcg and reduced opioid use vs placebo REC-11-010 Dex-IN Chronic lower back pain POC study (n=24) Statistically significant pain relief within 30 minutes demonstrated in placebo controlled trial – single use device REC-09-003 Dex-SL Chronic lower back pain POC study (n=21) Statistically significant reduction in pain intensity demonstrated in placebo controlled trial
Study REC-14-013 (Adverse Events – ≥3 in Dex-IN Group) Placebo DEX-IN 50 µg Adverse Event (N = 84) (N =84) BP Decreased 3 (3.6%) 22 (26.2%) Nausea 14 (16.7%) 13 (15.5%) Nasal Discomfort 2 (2.4%) 7 (8.3%) Headache 4 (4.8%) 6 (7.1%) Vomiting 6 (7.1%) 4 (4.8%) Nasal Dryness 3 (3.6%) 4 (4.8%) Nasal Congestion 1 (1.2%) 4 (4.8%) Nasal Obstruction 2 (2.4%) 3 (3.6%) Bradycardia 0 3 (3.6%) Dizziness 1 (1.2%) 3 (3.6%) Hypotension 0 3 (3.6%) If IV fluid given and no symptoms present, “BP Decrease” recorded as AE No medication given to any patient with BP or HR change All nasal related AEs were rated as mild, except one case of nasal congestion rated as moderate
Fadolmidine (“Fado”)
Fado Effective in Phase II for Pain Relief Alpha 2 agonist more potent at the alpha 2c receptor than Dex >20 fold less potent at the alpha 1b receptor than clonidine Fado has demonstrated analgesia in multiple animal models Positive Phase II analgesia study in bunionectomy patients Intrathecal route of administration WW rights to all human uses except Europe, Turkey and CIS NCE patent w/ expected extension to 2021
Clinical Pipeline Intellectual Property IV/IM meloxicam – formulation IP through 2022 and additional methods of preparation IP through May 2030 Dex applications for methods for treating/preventing pain through intranasal and sublingual formulations without significant sedation Fado IP in-licensed from Orion Composition of matter Method of administration for analgesia Treatment and prevention of hypotension and shock Pro-Drug Regulatory exclusivity 505(b)(2) – 3 years (Meloxicam, Dex-IN, Dex-SL) 505(b)(1) – NCE, 5 years (Fado)
Manufacturing Business Overview Gainesville
Gainesville Manufacturing Facility
Manufacturing Overview Manufacturing facility 97,000 + sq. ft. solid oral dosage manufacturing cGMP DEA licensed; ~170 employees Revenues include product sales, royalties and profit sharing Positive cash flow providing debt service and non-dilutive financing source for Company operating activities Service capabilities Formulation, process development and optimization Process scale-up Clinical supply and validation Commercial supply Ritalin LA Once daily ADHD treatment marketed by Novartis Focalin XR ADHD treatment marketed by Novartis Verelan / verapamil CV/High blood pressure treatment marketed by Actavis/Teva and Lannett Zohydro ER Extended release hydrocodone marketed by Pernix Launched in 2014 Abuse deterrent form launched
Strong Manufacturing Business Performance Revenues include product sales, royalties and profit sharing Expect 2016 revenues of $55M to $60M, given timing of customer ordering patterns Additional capacity for new product opportunities Positive cash flow for debt service obligations, as well as cash flow to provide non-dilutive financing to contribute to the funding of Company operating activities, including product development, and commercialization. *EBITDA and Excess Cash Flow are non-GAAP financial measures (see reconciliation page) Manufacturing Business ($millions) Six Months Ended June 30, 2016 (unaudited) Revenues $35.0 EBITDA* $15.1 Excess Cash Flow * $11.3
OrbiMed Debt Financing $50 million up-front payment funded via a five-year senior secured term loan with OrbiMed Interest at LIBOR + 14.0%, with a 1.0% LIBOR floor OrbiMed received warrants to purchase an aggregate of 3% of Recro's outstanding common stock (on a fully diluted basis) as of the closing of the transaction. Paid down $22.7 million (including $3.7 million paid in August), or 45% of the original $50.0 million term loan from excess cash flow generated by the manufacturing business
Company Highlights Multiple non-opioid therapeutics in advanced clinical development for pain conditions Progressing Phase III clinical trials for IV Meloxicam Reported positive top-line results for pivotal trial in patients following bunionectomy surgery Enrollment continues in second pivotal trial in patients following mini abdominoplasty surgery. On track to report top-line results by end of 2016 Enrolling safety study of 700 patients Assuming positive results from the clinical trials, plan to file a New Drug Application for IV Meloxicam approximately mid-summer 2017 Dex-IN – proprietary, intranasal therapeutic pursuing peri-procedural pain with eventual further Phase II work Revenue and cash flow positive manufacturing business Experienced management team with significant development, regulatory and commercial experience
Supplemental Financial Information Additional Financial Information - Consolidated ($millions) June 30, 2016 Cash and Cash Equivalents $14.8 Six Months Ended June 30, 2016 Total Revenue $35.0 R&D Expense $16.1 G&A Expense $5.4 Net Loss $14.4
Reconciliation of Non-GAAP Financial Measures Manufacturing Business ($millions) Six Months Ended June 30, 2016 (unaudited) Manufacturing pre-tax income $8.9 Depreciation $2.5 Amortization of intangible assets $1.3 OrbiMed debt interest $2.4 EBITDA $15.1 OrbiMed debt interest ($2.4) Capital expenditures ($1.2) Change in working capital ($0.5) Stock-based compensation expense $0.3 Excess Cash Flow $11.3 To supplement our financial results determined by U.S. generally accepted accounting principles ("GAAP"), we have also disclosed in the table below the following non-GAAP information for our Manufacturing Business: earnings before interest, taxes, depreciation and amortization ("EBITDA") and Excess Cash Flow. We believe these non-GAAP financial measures are helpful in understanding our Manufacturing Business as such useful to investors in allowing for greater transparency of supplemental information used by management. EBITDA is used by investors, as well as management in assessing our performance. Excess Cash Flow is used by our lender (OrbiMed) to determine the amount which OrbiMed may require the Company to prepay our loan per the credit agreement (see Notes to Financial Statements). Excess Cash Flow is also a useful measure of cash flow available to service debt, as well for other Company operating activities, including product development and commercialization. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.