Recro Announces Acquisition of San Diego-based IRISYS, Creating Bi-Coastal, Full Service CDMO

Recro Pharma, Inc. | August 16, 2021

Recro Announces Acquisition of San Diego-based IRISYS, Creating Bi-Coastal, Full Service CDMO
Recro Pharma, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today announced its acquisition of IRISYS, a San Diego-based CDMO that possesses capabilities that complement and expand those of Recro. Recro acquired IRISYS for approximately $50 million in a combination of cash, shares of Recro common stock and a seller promissory note. With its acquisition of IRISYS, Recro has transformed itself into a full service CDMO with operations on both the East and West Coast of the U.S. capable of offering its now expanded global client base access to services spanning from pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for wide range of dosage forms.

“Today’s acquisition of IRISYS is truly a transformative transaction for Recro. The joining of these two companies creates an organization that is ideally positioned to achieve Recro’s previously disclosed four-pronged strategy for growth, which includes strengthening the organization’s leadership and talent, expanding and diversifying our client base, fortifying our financial position, and enhancing our capabilities and competencies,” said David Enloe, president and chief executive officer of Recro. “Adding the personnel, facilities, capabilities and global customer base of IRISYS advances each of these goals and positions Recro for sustainable, profitable growth moving forward. We welcome the members of the IRISYS team to the Recro family and are eager to begin implementing the integration of the companies.”

IRISYS is a full service CDMO based in San Diego, CA with capabilities that range from formulation development to commercial manufacturing for various dosage forms including oral liquids, sterile injectables, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles. IRISYS serves a diverse, global client base within the biopharmaceutical industry with its nearly 40 clients located in six different countries around the world. This includes manufacturing support for four commercial and near-commercial products. Importantly, IRISYS recently added automated, aseptic fill/finish and lyophilization capabilities to its existing facility, offering a new key avenue for significant near-term growth. IRISYS expects to generate $15.4 million in revenue for full year 2021 and has approximately $23 million spanning its contracted backlog and vetted sales pipeline.

Strategic Rationale

Recro’s acquisition of IRISYS was driven by a number of compelling factors covering the four prongs of the company’s ongoing growth strategy.

Enhances Capabilities and Competencies:

Expands technical focus beyond oral solid dose to include sterile injectables oral liquids, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles; Adds new capabilities in the areas of aseptic fill/finish and lyophilization; and Establishes bi-coastal footprint from which to better serve clients within the U.S., as well as globally.
Expands and Diversifies Client Base:

Adds more than three dozen clients spanning six countries, reducing Recro’s customer dependency risk; Provides greater balance between our clinical and commercial project mix; and Diversifies portfolio from exclusively oral solid dose to a balance of multiple advanced dosage forms and oral solid dose.

Fortifies Financial Position:

Adds profitable business with IRISYS full year 2021 estimated revenues of $15.4 million, net income of $2.1 million and EBITDA* of $2.8 million; the corresponding anticipated improvement in Recro’s EBITDA will be beneficial to Recro’s debt covenants under its credit agreement. Recro intends to provide updated financial guidance when it releases third quarter 2021 earnings;
Offers significant revenue diversification, reducing financial reliance on any particular client or service offering; Becomes accretive by the fourth quarter of 2021, excluding integration costs; and Enables transaction-related paydown of credit facility and an extension of the due date, leading to improved cash flow.
In addition to the advancement of the company’s four-pronged growth strategy, the acquisition was also driven by key synergies between Recro and IRISYS within business development, clinical development and commercial scale-up, as well as a strong cultural alignment and fit between the companies.

Transaction Details

Under terms of the agreement, Recro has acquired 100% of the equity interests of IRISYS in exchange for consideration having an aggregate value of approximately $49.850 million. The purchase price was paid through: (i) $25.5 million of cash at closing; (ii) 9,302,718 shares of common stock of Recro to be issued in six months; and (iii) a seller promissory note of $6.1 million. The seller note has a three (3) year maturity date from the date of closing and bears interest at a rate of 6% annually. The seller note is expressly subordinated and unsecured in right of payment and priority to Recro’s existing debt with Athyrium Capital Management.

Bailey Southwell & Co. served as the exclusive financial advisor to IRISYS. William Blair & Company, L.L.C. represented Recro on the transaction.

Non-GAAP Financial Measures
Certain financial measures of IRISYS presented in this press release, including EBITDA, were not calculated using U.S. generally accepted accounting principles (“GAAP”). We believe these financial measures are helpful in understanding IRISYS’ business because it allows for greater transparency of supplemental information used by Recro’s management in connection with the acquisition of IRISYS. These measures are used by investors, as well as Recro’s management, in assessing IRISYS’ past and potential future performance. 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. Please see the section of this press release titled “IRISYS, LLC Reconciliation of GAAP to Non-GAAP Financial Measures” for a reconciliation of Non-GAAP EBITDA, to its most directly comparable GAAP measure.

About Recro
Recro is a contract development and manufacturing organization with capabilities from early feasibility to commercial manufacturing. With an expertise in solving complex manufacturing problems, Recro is a CDMO providing oral solid dosage form development, end-to-end regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified release oral solid dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 120,000 square feet, in Gainesville, Georgia.


In this video i have tried to explain the importance of the field of Pharmaceutical Sciences and give an example of how impactful one can be through the discoveries made in Pharmaceutical Sciences.

Related News


Atara Biotherapeutics and Pierre Fabre Enter Strategic Collaboration to Commercialize Tabelecleucel (Tab-cel®)

Atara Biotherapeutics, Inc. | October 04, 2021

Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre today announced an exclusive commercialization agreement for tabelecleucel (tab-cel®) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers. Atara will retain full rights to tab-cel® in other major markets, including North America, Asia Pacific, and Latin America. Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel® in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel® to be paid by Pierre Fabre. Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel® is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel® has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA). Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships, Our Companies’ complementary capabilities will expand access to tab-cel®, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers. - Pascal Touchon, President and CEO of Atara. Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology. PJT Partners served as the exclusive financial advisor to Atara. About Tabelecleucel Tabelecleucel (tab-cel®) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences. Tab-cel® is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care. Tab-cel® has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel® has orphan drug designation in the U.S. and EU. About Pierre Fabre Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio ranges across several medical franchises and international brands, including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive and Pierre Fabre Oral Care. In 2020, Pierre Fabre generated €2.3 billion in revenues, 65% of which came from international sales. Established in the South-West area of France since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan. In 2020, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard for the 2nd consecutive year and confirmed its “Excellence” level. For further information, please visit the Pierre Fabre website at About Atara Biotherapeutics, Inc. Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients’ lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California.

Read More


Azzur Group Announces Executive Leadership Changes

Azzur Group, LLC | January 13, 2022

To support rapid company growth and best meet the demands of the business, Azzur Group announces new executive leadership appointments. Originally founded in Philadelphia in 2010, Azzur is a market-leading provider of GxP services for the pharmaceutical, biotechnology, medical device, and healthcare industries with offices and on-demand cleanrooms locations throughout the United States. Today, the organization provides comprehensive GxP solutions through its on-demand cleanrooms, consulting and advisory services, microbiology labs, and aseptic and GxP training. Ryan Ott has been promoted to Chief Operating Officer of Azzur Group. A long-time partner at Azzur, Ryan most recently served as Chief Administrative Officer. During his tenure, he has been instrumental in the overall strategic development of Azzur Group, initially in the Greater Philadelphia Region, while taking on additional responsibility with ongoing national expansion. In his new role, he collaborates with corporate and service-line leaders throughout the organization to execute on Azzur Group's strategic business plan. This includes Shaleen Parekh, who has been appointed to Sr. Vice President of Professional Services, with continuing oversight for Azzur Consulting, Azzur Labs, and Azzur Training Center; and Molly McGlaughlin, who has been appointed Sr. Vice President of Facilities Services, with continuing oversight for Azzur Cleanrooms on Demand™ as its Chief Operating Officer. Appointed to the new role of Chief Innovation Officer is Ravi Samavedam. In this role, he will focus on bringing forward new business concepts and service areas for Azzur's continued expansion. Ravi's extensive life sciences industry experience and dynamic leadership of Azzur Cleanrooms on Demand™ from its creation in 2018 through its national expansion, ideally position him to proactively identify novel service offerings for the enterprise. Most recently, Ravi served as President and COO of Azzur Cleanrooms on Demand™. He has been a member of Azzur Group since 2014. Ilya Vasserman has been promoted to Chief Information Officer (CIO) of Azzur Group and is responsible for overseeing the management and scale-out of Azzur's corporate information technology infrastructure while forming and leading a new corporate-wide procurement group. Ilya will also continue to spearhead technology adoption and internal tool development, furthering our business insights capabilities. Ilya most recently served as Senior Director of Financial Services and has been a member of Azzur Group since 2016. After nearly two years with Azzur Group, David Frank has been promoted to Vice President of Client Development, furthering the growth and maturation of Azzur's business development and marketing capabilities. As part of his expanded responsibilities, David will work closely with the executive leadership team to develop client-centric strategies across the organization to meet customer needs. Since joining Azzur Group in 2020, David has served as the Senior Director, Sales and Marketing. "I'm incredibly thrilled to announce the changes to the Azzur Group executive leadership team. Not only have these individuals proven to be excellent strategic partners for our enterprise, but each embodies Azzur Group's core values in their daily leadership. I offer my sincerest congratulations to Ryan, Ravi, Shaleen, Molly, Ilya, and David, and wish them much success in their new roles." Michael Khavinson, Azzur's Chief Executive Officer About Azzur Group Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

Read More

Tetra Bio-Pharma Gets Orphan Drug Status For CBD Drug

Greenmarketreport | April 22, 2020

Tetra Bio-Pharma Inc. (OTCQB:TBPMF) announced its Orphan Drug development strategy and provided a management update. The company said it is focusing on generating intellectual property including use, manufacturing, and innovative molecule protection. Tetra said it received a U.S. Food and Drug Administration (FDA) Orphan Drug Designation for secondary cannabidiol (CBD) formulation of its cannabinoid topical drug PPP004 in the treatment of epidermolysis bullosa. “Each ODD application is driven by scientific data generated by Tetra’s research and development department and in line with a commercialization strategy. Tetra is positioning itself as a world leader in cannabinoid drug development and increasing its ODD portfolio provides opportunities that will allow us to generate value for shareholders. Over the coming weeks, Tetra shall expand on its commercial ophthalmic and topical drug programs,” said Dr. Chamberland CEO & CRO, Tetra Bio-Pharma Inc.

Read More


In this video i have tried to explain the importance of the field of Pharmaceutical Sciences and give an example of how impactful one can be through the discoveries made in Pharmaceutical Sciences.