GlobeNewswire Inc | Aug 9, 2021 04:05PM EDT

August 09, 2021

-- NUZYRA(omadacycline) Generated Net U.S. Sales of $14.9 Million from the Core Commercial Business, a 13% Increase over the Prior Quarter

-- Reported $37.9 Million in Revenue from the Delivery of the First BARDA Procurement of NUZYRA

-- Received FDA Approval of NUZYRA Oral Only Loading-Dose Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)

-- Initiated Phase 2b Study in Non-Tuberculous Mycobacterium Abscessus

BOSTON, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government andmilitary use, today reported financial results and provided an update on corporate activities for the quarter ended June 30, 2021.

We continued to deliver consistent growth and progress in the second quarter with the core NUZYRA commercial business seeing quarter over quarter growth, as net sales increased 13% to $14.9 million versus the first quarter, said Evan Loh, M.D., Chief Executive Officer at Paratek. We were also excited to announce that the first BARDA procurement valued at $37.9 million was delivered and accepted in the second quarter as we continued to execute on all aspects of this unique contract with BARDA. NUZYRAs label was expanded in the second quarter with the FDA approval of the oralloading dose regimen forcommunity-acquired bacterial pneumonia. Importantly, we continued to advance our pipeline for NUZYRA with the initiation of aPhase 2b non-tuberculous mycobacteria(NTM) abscessus study, a rare disease for which there are no approved therapies.

Highlights

-- Oralloading dose regimen forCABP: Received FDA approvalfor NUZYRAsoralloading dose regimen forCABP in lateMay2021. Plans have been established to broadenthe Companys community-based sales effort in the primary care settingto include CABP later this year in anticipation of the 2021/2022 flu season. The Company estimates that CABP in the primary care setting has a $1.5 billion addressable market opportunity in the U.S. -- NTM abscessus rare disease opportunity: Initiated a Phase 2b study in June 2021 to explore the potential utility of omadacycline as a treatment for NTM abscessus pulmonary infection, a rare disease with no approved therapies, which the Company estimates is a $1.0 billion addressable market opportunity in the U.S. -- Continued progress of the BARDA ProjectBioShieldanthrax program:Biomedical Advanced Research and Development Authority (BARDA) accepted the first procurement of NUZYRA valued at $37.9 million. The Company continues to execute and deliver on its five-year contract with BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), to develop NUZYRA for the treatment of pulmonary anthrax, a critical bioterrorism threat deemed important to national security by BARDA. These activities include advancing the U.S. onshoring of NUZYRA manufacturing and the continued execution of certain preclinical research activities supporting the pulmonary anthrax development program. -- NUZYRA added to the Center for Disease Control and Preventions (CDC) Plague Guideline: The Companys novel, once-daily oral and intravenous antibiotic NUZYRA has recently been added to the CDCs updated guideline, Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response. The addition of NUZYRA provides further validation of the potential utility of the drug against pathogens that cause health security threats such as plague. -- Nuzyra included in CHEST, Treatment of Mycobacterium abscessus Pulmonary Disease: Two recognized NTM experts, who are NTM treatment guideline authors, collaborated on a recently published review article that expands on the current guidelines for the treatment of pulmonary M. abscessus infections. The authors included omadacycline in their recommended treatment options based on its potent in vitro activity and reports of clinical success in real-world NTM abscessus case series. In particular, the authors highlighted the importance of NUZYRAs oral formulation given the lack of currently available oral treatment options.

Second Quarter 2021 Financial Results Total revenuewas$57.5millionfor thesecondquarter of 2021.

-- NUZYRA generated $52.8 million in net U.S. sales during the second quarter of 2021. This revenue includes $14.9 million from the core commercial business, a 13% increase over the first quarter of 2021 and an 84% increase over the second quarter of 2020, and $37.9 million from the first BARDA procurement. -- Governmentcontract serviceand grantrevenue earned from costs incurred under the BARDA contractwas$4.2millionfor thesecondquarter of 2021versus$2.6million in the first quarter of 2021 and $0.9 million in the second quarter of 2020.

Research and development(R&D)expenseswere $6.5 million for the secondquarter of 2021, compared to $4.6 million forsame period in the prior year. The increase in R&D expenses for the second quarter of 2021 was primarily due to $4.2 million in costs reimbursed under the BARDA contract, which included costs for the U.S. onshoring of NUZYRA manufacturing and for FDA post-marketing requirements, or PMRs, associated withthe approval of NUZYRA. The remaining increase is mainly the result of start-up costs incurred for the Phase 2b NTM study.

Selling, general and administrative(SG&A)expenseswere $27.1 million for thesecond quarter of 2021, compared to $21.0millionfor thesame period in the prior year. The increase in SG&A expenses is primarily the result of costs incurred for the NUZYRA community expansion and an increase in stock-based compensation expense due to the probability and timing of the achievement of performance-based vesting milestones.

Paratek reported net income of $9.7million, or $0.20 per share, for thesecondquarter of 2021, compared to a net loss of $23.1million, or ($0.53) per share, for the same period in 2020.

Financial Guidance

-- Paratekis maintaining its previously disclosed financial guidance, which moved approximately $38 million associated with the second procurement of NUZYRA by BARDA from its 2021 revenue expectations. -- Based upon the Company's current operating plan, Paratek anticipates its existing cash and cash equivalents of $75.3 million as of June 30, 2021, plus the $37.9 million received from BARDA in July 2021 for the first procurement of NUZYRA, provides for a cash runway through the end of 2023 with a pathway to cash flow break even.

Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.

Call and WebcastParateks earnings conference call for the quarter ended June 30, 2021 will be broadcast at 4:30 p.m. EDT on August 9, 2021. The live audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of Parateks website at www.ParatekPharma.com.

Domestic investors wishing to participate in the call should dial: 855-327-6837 and international investors should dial: 631-891-4304. The conference ID is 10016029. Investors can also access the call at http://public.viavid.com/index.php?id=146149.

Website InformationParatek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Parateks website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Parateks website is not incorporated by reference into, and is not a part of, this document.

About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc.is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government andmilitary use.

The Company's lead commercial product, NUZYRA(omadacycline), isa once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement withZaiLab for the development and commercialization of omadacycline in the greaterChinaregion and retains all remaining global rights.

Paratek is also conducting a Phase 2b Study in a rare disease, Nontuberculous Mycobacterial (NTM) Pulmonary Disease, caused byMycobacterium abscessusComplex (MABc) with NUZYRA. Paratek estimates this opportunity represents a potential $1.0 billion addressable market in the U.S.

Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA(sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, toAlmirall, LLC(Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

In 2019, Paratek was awarded a contract from BARDA, valued up to $284.5 million,to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.

For more information, visitwww.ParatekPharma.comor follow @ParatekPharmaon Twitter.

About NUZYRANUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

Forward Looking StatementsThis press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potentialand expected results, including statements about our expectations regarding the Companys future growth and performance, the impact of COVID-19 on our revenue projections, the exercise and timing of BARDAs future procurements of NUZYRA for the SNS, the expected timing of certain regulatory decisions,, the benefits of our initiation of a Phase 2b NTM abscessus study and the potential market opportunity of NTM, the benefit of the expansion of the NUZYRA label, our plans to broaden the Companys sales efforts, our expectation to continue to execute and deliver on our BARDA contract, and our anticipated cash runway. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as will be, "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K forthe year ended December 31, 2020 and our other filings with the SEC. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

PARATEK PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets(unaudited)(in thousands)

June 30, December 31, 2021 2020 Cash, cash equivalents and marketable $ 75,298 $ 125,162 securitiesTotal assets 179,588 176,853 Working capital 132,527 140,164 Total current liabilities 20,977 23,953 Long-term debt 252,759 250,474 Common stock and additional 717,137 705,535 paid-in-capitalAccumulated deficit (816,428 ) (807,799 )Total stockholders' deficit (99,291 ) (102,260 )

Condensed Consolidated Statements of Operations(unaudited)(in thousands, except per share data)

Three Months Ended Six Months Ended June30, June 30, 2021 2020 2021 2020 Product revenue, $ 52,803 $ 8,133 $ 66,009 $ 15,436 netGovernmentcontract service 2,113 439 3,086 775 revenueGovernmentcontract grant 2,087 437 3,701 437 revenueCollaboration and 489 317 1,123 597 royalty revenueNet revenue $ 57,492 $ 9,326 $ 73,919 $ 17,245 Expenses: Cost of product 9,778 2,236 12,529 3,707 revenueResearch and 6,519 4,561 12,057 10,949 developmentSelling, general 27,106 20,975 49,465 44,613 and administrativeTotal operating 43,403 27,772 74,051 59,269 expensesIncome (loss) from 14,089 (18,446 ) (132 ) (42,024 )operationsOther income and expenses:Interest income 11 363 36 1,067 Interest expense (4,344 ) (4,971 ) (8,651 ) (9,797 )Other gains (39 ) (5 ) 118 78 (losses), netNet income (loss) $ 9,717 $ (23,059 ) $ (8,629 ) $ (50,676 )Othercomprehensive income (loss)Unrealized gain(loss) onavailable-for-sale ? (217 ) (4 ) 180 securities, net oftaxComprehensive $ 9,717 $ (23,276 ) $ (8,633 ) $ (50,496 )income (loss)Earnings (loss) per common shareBasic $ 0.20 $ (0.53 ) $ (0.18 ) $ (1.19 )Diluted $ 0.20 $ (0.53 ) $ (0.18 ) $ (1.19 )Weighted averagecommon stock outstandingBasic 47,122,717 43,629,836 46,894,812 42,635,520 Diluted 48,945,736 43,629,836 46,894,812 42,635,520

CONTACT:

Investor Relations:Hans VitzthumLifeSci AdvisorsPhone:617-430-7578ir@ParatekPharma.com

Media:Beth KramliScient PRPhone: 908-568-9721beth@scientpr.com