 Commercialization and launch of first royalty bearing products position company for next phase of growth Multiple U.S. health plans add Teriparatide Injection to their formulary upon its June 2020 launch as Pfenex and Alvogen continue to pursue therapeutic equivalence designation; Received EU CHMP positive opinion Pfenex enters into new research collaboration and license agreement with Merck Co. Inc., with the potential to earn up to 293M in upfront, development, and sales milestones Receipt of India Marketing Authorization and first Pneumosil UNICEF tender awarded to Serum Institute of India Private Limited SII which utilizes Pfenex CRM197 Pfenex continues to progress new development programs PF810 and PF901 and novel programs using its VHH platformSAN DIEGO, Aug. 06, 2020 GLOBE NEWSWIRE -- Pfenex Inc. NYSE American: PFNX reported financial results for the second quarter ended June 30, 2020 and provided a business update.The second quarter of 2020 marked a significant milestone for Pfenex as our partner, Alvogen, launched Teriparatide Injection in the U.S. in June. said Eef Schimmelpennink, CEO of Pfenex. Making the product commercially available while we continue to seek therapeutic equivalence TE rating relative to Forteo teriparatide injection, provided an opportunity to accelerate patient access to a cost-effective alternative to this important drug and initial market feedback has been encouraging. Following the FDAs April General Advice Letter and as part of an active and on-going dialogue, the FDA has provided additional direction around the methodology to be used in a new comparative use human factors CUHF study focused on a larger group of Forteo experienced users in order to support a therapeutic equivalence evaluation. Having taken the totality of feedback into account, including a General Advice Letter dated July 2020, Alvogen has recently provided the FDA with an updated CUHF protocol.Outside of the U.S. we made significant progress as PF708 was issued a positive opinion by the CHMP, which we believe positions the product candidate for final approval by the European Commission in the second half of 2020. Furthermore, with Alvogen, we continue to increase the number of partners supporting the global regulatory and commercial strategy for PF708, with two new sublicensees in Latin America.The second quarter of 2020 also saw interest in the capabilities of the Pfenex Expression Technology platform from collaboration partners, highlighted by todays announcement of our research collaboration with Merck, as well as continued momentum across our other late stage and commercial collaborations, including the first commercial agreement by SII with its CRM197-based Pneumosil vaccine; patient enrollment in Jazz Pharmaceuticals Phase 3 clinical trial of JZP-458, which has received fast-track designation; and positive Phase 3 data shared by Merck for its CRM197-based V114 pneumococcal vaccine candidate.The realization of what we believe to be potential near-term revenue opportunities is expected to enable us to continue expanding our collaborations and partnerships as well as pursue novel biopharmaceutical development, he continued. Looking forward, we believe there are several important milestones on the horizon that have the potential to drive long-term shareholder value, including the continued preclinical development of our next generation molecules and continued portfolio expansion with VHH single domain antibody candidates concluded Mr. Schimmelpennink. Business Review and UpdateTeriparatide Injection Product PF708 is approved in the U.S. under the 505b2 regulatory pathway, with Forteo teriparatide injection as the listed drug, and commercially launched under the brand name Teriparatide Injection. Outside of the U.S., PF708 remains in various stages of regulatory and marketing application processes and, upon approval, may be marketed as Teriparatide Injection or under various tradenames, such as Bonsity, Livogiva, or Qutavina. Pfenex refers to the product as Teriparatide Injection for discussions related to the U.S. market, as PF708 in markets where regulatory approval is pending or outstanding, and as teriparatide injection product in general discussions of the product. In June 2020, Pfenexs commercialization partner for Teriparatide Injection, Alvogen, initiated the U.S. commercial launch of Teriparatide Injection prior to obtaining a positive FDA decision on TE. In conjunction with the launch, Alvogen continues to negotiate with major U.S. health care plans, several of which added the product to their formularies, commenced digital marketing campaigns and shipped initial stocking orders to wholesalers. Pfenex is eligible to receive tiered royalties on gross profits earned from Alvogens sale of Teriparatide Injection of 25 to 40, which increases to 50 on all gross profits if the TE designation is awarded.In its July 2020 General Advice Letter, the FDA provided additional feedback and direction regarding the methodology to be used in a new CUHF study the FDA deemed necessary to help support a therapeutic equivalence evaluation. In response, we worked with Alvogen to finalize a CUHF protocol intended to address the FDAs feedback. The new protocol has been delivered to the FDA for its review. We intend to commence the study after the FDAs review of the protocol.In June 2020, the Committee for Medicinal Products for Human Use of Medicines provided a positive opinion on PF708. The CHMPs recommendation will now be considered by the European Commission to determine whether to grant marketing authorization, which typically occurs within 67 days of the CHMP recommendation and could potentially lead to regulatory approval as early as the second half of 2020. If approved, PF708 would receive marketing authorization in the more than 25 member states of the European Union, as well as in Iceland, Liechtenstein and Norway. Alvogen entered into a distribution and commercialization agreement with two sublicensees, one a large, multinational pharmaceutical company to commercialize PF708 in Brazil, Columbia, Mexico, Ecuador, Paraguay, and Peru, upon receipt of applicable marketing authorizations.From a global commercialization perspective, teriparatide injection is supported by a network of 10 regional commercial partners covering 48 countries. As of August 6, 2020, teriparatide injection has been included within six regulatory and marketing submissions and has achieved one approval covering one country with the five additional submissions still under review.Pfenex believes Teriparatide Injection and PF708, upon approval for marketing in other countries, as well as a positive therapeutic equivalence designation from the FDA, has the potential to enhance patient access to an important treatment as a potential cost-effective alternative to Forteo, which had 1.4 billion in global sales in 2019.Jazz Collaboration AgreementPfenex has a development and license agreement with Jazz Pharmaceuticals plc Jazz for multiple hematologic oncology products including PF743 JZP-458, a recombinant Erwinia asparaginase, and PF745 JZP-341, a long-acting Erwinia asparaginase. Jazz has received fast track designation for PF743, and recently stated that it anticipates the filing of the biologics license application as early as the fourth quarter of 2020. The Phase 3 clinical trial, consisting of approximately 100 patients with a planned interim analysis at approximately 50 patients, is being conducted in collaboration with Childrens Oncology Group. Under the terms of the development and license agreement, Pfenex is eligible to receive an aggregate total of up to 224.5 million in development and sales milestone fees. At June 30, 2020, 162.5 million of development and sales milestones are still eligible to be received by Pfenex, including up to 3.5 million for development milestones, 34.0 million in regulatory milestones and 125 million in sales milestones. Pfenex is eligible to receive tiered royalties based on worldwide sales of any products resulting from the collaboration.Pfenex believes PF743 and PF745, upon approval, have the potential to resolve historical product supply challenges and enhance global patient access to an important therapy as an alternative to Erwinaze.Pfenex also continues to progress PF690, a pegaspargase, in accordance with the Jazz agreement. Jazz maintains an exclusive option to license this product pursuant to certain option triggers.CRM197CRM197 is a non-toxic mutant of diphtheria toxin. It is a well characterized protein and functions as a carrier for polysaccharides and haptens, making them immunogenic. CRM197 is used in prophylactic and therapeutic vaccine candidates. The Company has developed unique CRM197 production strains based on its Pfenex Expression Technology platform. Preclinical grade and cGMP CRM197 is supplied to several vaccine development focused pharmaceutical customers and unique strains have been exclusively licensed to Merck and SII for use in their conjugate vaccine products including candidates for pneumococcal and meningitis bacterial infections. Pneumococcus bacterium is a leading cause of severe pneumonia and major cause of morbidity and mortality worldwide.Merck is using CRM197 produced by Pfenex Expression Technology in its V114 PCV-15 vaccine, an investigational 15-valent conjugate vaccine for the prevention of pneumococcal disease, currently in 17 Phase 3 studies. In June, Merck announced positive results from two of the initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, which were published via the International Symposium on Pneumococci and Pneumococcal Diseases online digital library. 