Recro Pharma, Inc. (REPH) 10-K Annual Report Wed Mar 25 2015

– Strengthened Company with Expected Acquisition of Phase III-Ready IV/IM Meloxicam, Cash Flow Positive Manufacturing/Formulation Business from Alkermes –

MALVERN, PA, March 25, 2015 – Recro Pharma, Inc. (Nasdaq: REPH), a clinical stage specialty pharmaceutical company developing non-opioid therapeutics for the treatment of acute post operative pain, today reported financial results for the fourth quarter and full year ended December 31, 2014.

“In late 2014 and early 2015 we made significant advancements on both the clinical and corporate fronts,” said Gerri Henwood, Recro Pharma’s President and Chief Executive Officer. “Our Phase II Post Op Day 1 trial is progressing and we expect to receive results from our interim analysis shortly and top-line results in mid 2015. We believe we have and will have significantly strengthened the Company with our recent strategic transactions, including the pending acquisition of Phase III-ready IV/IM meloxicam, as well as the addition of a revenue-generating, cash flow positive manufacturing and royalty facility, and a $10 million committed equity line from Aspire Capital. Depending on the clinical success of Dex-IN, we look forward to the potential of moving two complementary acute pain programs into Phase III by year end.”

Fourth Quarter 2014 and Recent Highlights

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Acquired assets from Alkermes: In March 2015, Recro Pharma announced an agreement under which the Company will acquire assets from Alkermes plc, including worldwide rights to IV/IM meloxicam, a proprietary, Phase III-ready, long-acting COX-2 NSAID for moderate to severe acute pain, as well as a cash flow positive contract manufacturing facility, royalty and formulation business in Gainesville, GA. IV/IM meloxicam has demonstrated robust efficacy and good tolerability in multiple Phase II trials. The transaction was funded via a five-year senior secured term loan with an affiliate of OrbiMed. This transformative acquisition diversifies Recro Pharma’s development risk by adding a second, complementary acute pain product to the Company’s product pipeline. Depending on the clinical success of Dex-IN, Recro Pharma could potentially have two proprietary compounds enter Phase III by year end 2015, as well as a commercial manufacturing infrastructure that will add scale and capability and may provide cash flow to fund development of the Company’s pipeline over time. The acquisition is subject to customary closing conditions, including antitrust regulatory approval, and is anticipated to close in the second quarter of 2015.

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Executed Stock Purchase Agreement with Aspire Capital: In February 2015, Recro Pharma entered into a common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire Capital”). Under the agreement, Recro Pharma has the right to sell up to $10 million in shares of common stock to Aspire Capital, subject to certain terms and conditions over a two-year period. The agreement represents an additional method to provide the Company with increased capital and flexibility.

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Dosed First Patient in Phase II Dex-IN Post Op Day 1 Acute Pain Clinical Trial: In October 2014, Recro Pharma announced dosing of the first patient in a randomized, multicenter, double-blind, placebo-controlled Phase II clinical trial of Dex-IN in patients who initiate dosing of study medication on Post Op Day 1, following bunionectomy surgery. The trial is expected to enroll approximately 200-250 patients. The primary efficacy endpoint of the trial is the summed pain intensity difference over 48 hours, SPID48, starting on Post Op Day 1. Additional efficacy endpoints include use of opioid rescue medication and opioid related side effects, and Patient Global Assessment (PGA) of pain control. Recro Pharma is expecting results from its interim analysis shortly, and remains on track to report top-line data from this trial in mid 2015.

The following information was filed by Recro Pharma, Inc. (REPH) on Wednesday, March 25, 2015 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Recro Pharma, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.14: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.3: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32: Section 1350 Certification

Ticker: REPH
CIK: 1588972
Form Type: 10-K Annual Report
Accession Number: 0001193125-15-104307
Submitted to the SEC: Wed Mar 25 2015 10:05:27 AM EST
Accepted by the SEC: Wed Mar 25 2015
Period: Wednesday, December 31, 2014
Industry: Pharmaceutical Preparations