Tetracycline Hydrochloride

-- NUZYRA® (omadacycline) Generated Net U.S. Sales of $26.2 Million from the Core Commercial Business, a 32% Increase Over First Quarter 2022 -- Company Reiterates Full-Year Revenue Guidance of $143 to $158 Million -- Announces Full-Year R&D and SG&A Expense Guidance of $160 to $170 Million, Approximately $20 Million in Savings Over Annualized Fourth Quarter 2022 Spend Rate1, Enabled by Operational Efficiencies BOSTON, May 09, 2023 (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 and military use, today reported financial results and provided an update on corporate activities for the first quarter ended March 31, 2023. “The continued and robust year-over-year growth in our NUZYRA core commercial revenue combined with the sales momentum seen in the latter half of the first quarter, which has continued through April, supporting our confidence in our commercial strategy,” said Evan Loh, M.D., chief executive officer at Paratek. “The strong demand we have seen in our commercial business to date, along with the progress we are making in our BARDA contract, allows us to reiterate 2023 revenue guidance of $143 to $158 million. Consistent with our commitment to accelerate our pathway to profitability, 2023 R&D and SG&A expense guidance is $160 to $170 million, which represents a significant reduction from our annualized fourth quarter 2022 spend rate1 that will be achieved through operational efficiencies.” _______________1 R&D and SG&A expense in the fourth quarter of 2022 was $68.1 million, which included a contingent non-recurring charge of $21.9 million. Excluding this charge, R&D and SG&A expense in the fourth quarter of 2022 was $46.2 million, which incorporated the full cost burden of the community sales expansion completed in the second half of 2022. Recent Highlights Non-Tuberculous Mycobacteria (NTM) Rare Disease Program: Real World Evidence Presentation: In a poster presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April 2023 entitled, “A Multicenter Evaluation of Treatment Durability and Safety of Omadacycline for Mycobacterium abscessus Infections,” omadacycline demonstrated a high degree of clinical durability and safety at three, six, and 12 months in 63 patients with NTM infections.Ex-US Outlicensing Opportunities: Following the receipt of formal guidance on a NTM registration program in Japan during the first quarter, the company has initiated regulatory activities in Europe focused on establishing orphan disease designation and a development pathway for approval of NUZYRA for NTM caused by Mycobacterium abscessus. Progress on partnerships focused on the development and commercialization of NUZYRA for NTM in both Japan and Europe continues. The company anticipates a formal partnership in Japan to be announced in the second half of 2023.Development Program: Enrollment continues in an ongoing Phase 2b study designed to explore the potential utility of omadacycline as a treatment for NTM pulmonary infections due to Mycobacterium abscessus. The company anticipates that enrollment will be complete by the end of 2023. First Quarter 2023 Financial Results Total revenue for the first quarter of 2023 was $31.2 million compared to $24.9 million for the same period in the prior year. Total revenue for the first quarter of 2023 was comprised of the following: NUZYRA net U.S. sales of $26.2 million, which represented a 32% increase from $19.9 million for the same period in the prior year.Government contract service and grant revenue earned from cost reimbursement under the BARDA contract of $3.8 million, a 12% decrease from $4.3 million for the same period in the prior year.Collaboration and royalty revenue of $1.2 million, a 71% increase from $0.7 million for the same period in the prior year, which primarily represents royalty revenues earned on sales of NUZYRA in China and on sales of SEYSARA® (sarecycline) in the United States. Research and development (R&D) expenses were $7.3 million for the first quarter of 2023, compared to $7.5 million for the same period in the prior year. Selling, general and administrative (SG&A) expenses were $33.5 million for the first quarter of 2023, compared to $27.6 million for the same period in the year. The increase in SG&A expenses is primarily the result of costs incurred in connection with the NUZYRA community expansion. Paratek reported a net loss of $20.1 million, or $(0.35) per share, for the first quarter of 2023, compared to a net loss of $17.9 million, or $(0.35) per share, for the same period in the prior year. Paratek had cash and cash equivalents of $45.0 million as of March 31, 2023. Based upon the Company’s current operating plan, this balance of cash and cash equivalents may not be sufficient to fund operations through the first quarter of 2024. The Company expects to address future cash needs, including the maturity of its outstanding convertible senior subordinated notes due May 2024, primarily through a combination of product sales, royalties, public or private equity offerings, debt or other structured financings, strategic partnership opportunities, government procurements and active management of cash and expenses through operational efficiencies. If these activities are successful, the Company expects to be able to fund operations beyond the first quarter of 2024. 2023 Financial Guidance Paratek reiterated its full-year 2023 revenue guidance announced earlier this year, which is expected to be in the range of $143 to $158 million, which includes the following components: NUZYRA net U.S. sales of approximately $125 to $135 million.BARDA government contract service and grant revenue between $15 to $20 million.Royalty and collaboration revenue of approximately $3 million. Paratek also announced its full-year 2023 R&D and SG&A expense guidance, which is expected to be in the range of $160 to $170 million, and include the following components: Core business R&D and SG&A expenses of $145 to $150 million.Reimbursable BARDA R&D and U.S. onshoring expenses of $15 to $20 million. Call and Webcast Paratek’s earnings conference call for the quarter ended March 31, 2023, will be broadcast at 4:30 p.m. EST on May 9, 2023. The live audio webcast can be accessed under “Events and Presentations” in the Investor Relations section of Paratek’s website at www.ParatekPharma.com Domestic investors wishing to participate in the call should dial: 1-800-920-3371 and international investors should dial: 1-212-231-2909. The conference ID is 22026760. Investors can also access the call at: https://viavid.webcasts.com/starthere.jsp?ei=1611304&tp_key=5fe62a51b9 Website Information Paratek 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 Paratek’s 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, Paratek’s 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 and military use. The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. 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, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. In 2019, Paratek was awarded a contract from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), now valued at up to $304 million, to support the development and U.S.-based manufacturing of NUZYRA for pulmonary anthrax. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. About NUZYRA® NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) 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. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about our expectations regarding the Company's future growth and performance, revenue and operating expense projections, our ability to continue to execute and deliver on our BARDA contract, the status of our Phase 2b NTM abscessus study, the potential market opportunity for NTM in the United States, Japan and Europe, the potential for a partnership in Japan and Europe for the development and commercialization of NUZYRA for NTM, 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 “expect,” “anticipate,” “continue,” “will” 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 for the year ended December 31, 2022 and our other filings with the Securities and Exchange Commission. 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) As of March 31, December 31, 2023 2022 Cash, cash equivalents and marketable securities$45,026 $34,248 Total assets 150,828 172,538 Working capital 78,269 99,454 Total current liabilities 32,745 37,388 Long-term debt 257,695 256,946 Common stock and additional paid-in capital 761,554 759,407 Accumulated deficit (950,592) (930,449)Total stockholders' deficit (189,038) (171,042) Condensed Consolidated Statement of Operations(unaudited)(in thousands, except loss per share data) Three Months EndedMarch 31, 2023 2022 Product revenue, net$26,213 $19,918 Government contract service revenue 1,806 2,172 Government contract grant revenue 2,028 2,099 Collaboration and royalty revenue 1,189 672 Net revenue$31,236 $24,861 Expenses: Cost of product revenue 6,244 3,494 Research and development 7,308 7,478 Selling, general and administrative 33,489 27,602 Total operating expenses 47,041 38,574 Loss from operations (15,805) (13,713)Other income and expenses: Interest income 221 107 Interest expense (4,476) (4,479)Other (losses) gains, net (22) 175 Net loss before provision for income taxes$(20,082) $(17,910)Provision for income taxes (61) — Net loss (20,143) (17,910)Other comprehensive (loss) Unrealized (loss) on available-for-sale securities, net of tax — (171)Comprehensive loss$(20,143) $(18,081)Basic and diluted net loss per common share$(0.35) $(0.35)Weighted average common stock outstanding Basic 56,903,420 52,149,538 Diluted 56,903,420 52,149,538 CONTACT: Investor Relations:Hans VitzthumLifeSci Advisorsir@ParatekPharma.comPhone: 617-430-7578 Media:Christine FanelleScient PRChristine@scientpr.comPhone: 215-595-5211

DUBLIN, March 10, 2023 /PRNewswire/ --Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the first generic version of Allergan's Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) 140 mg, 125 mg and 125 mg capsules in the U.S., following final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application. "We're proud to be a reliable, quality supplier providing choices to healthcare professionals and their appropriate patients," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "This first-to-market generic product strengthens our portfolio and is a lower-cost option for people who need the medication." Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules, in combination with omeprazole, are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past five years) to eradicate H. pylori. According to IQVIA™, Pylera® sales were approximately $30 million for the 12 months ended December 31, 2022. Pylera® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. IMPORTANT SAFETY INFORMATION FOR BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULES CONTRAINDICATIONS Methoxyflurane: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. the concurrent use of tetracycline hydrochloride, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride reported to result in fatal renal toxicity. Disulfiram: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. Alcohol: Alcoholic beverages or other products containing propylene glycol should not be consumed during and for at least 3 days after therapy with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride occur due to the interaction between alcohol or propylene glycol and metronidazole, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. Cockayne Syndrome: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated in patients with Cockayne Syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne Syndrome. Severe Renal Impairment: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated in patients with severe renal impairment. The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (bun). In patients with significantly impaired renal function, higher serum concentrations of tetracyclines may lead to azotemia, hyperphosphatemia, and acidosis. Pregnancy: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated during pregnancy. Hypersensitivity Reactions: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is contraindicated in patient with known hypersensitivity (e.g. urticaria, erythematous rash, flushing and fever) to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracyclines. WARNINGS AND PRECAUTIONS Fetal Toxicity: Tetracycline can cause fetal harm when administered to a pregnant woman. Based on animal data, use of drugs of the tetracycline class during the second and third trimester of pregnancy can cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development. If bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is used during pregnancy, or if the patient becomes pregnant while taking bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, advise the patient of the potential risk to the fetus. Maternal Toxicity: Tetracycline, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, administered during pregnancy at high doses (> 2 g iv) was associated with rare but serious cases of maternal hepatotoxicity. This syndrome may result in stillborn or premature birth due to maternal pathology. Tooth Enamel Discoloration and Hypoplasia: The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug, but has been observed following repeated short-term courses. Central and Peripheral Nervous System Effects: Metronidazole: convulsive seizures, encephalopathy, aseptic meningitis and peripheral neuropathy (including optic neuropathy) have been reported. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible. Aseptic meningitis symptoms may occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued. Tetracycline: intracranial hypertension (IH), including pseudotumor cerebri, has been associated with the use of tetracyclines. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin should be avoided because isotretinoin is also known to cause IH. Bismuth-containing products: cases of neurotoxicity associated with excessive doses of various bismuth-containing products have been reported. Effects have been reversible with discontinuation of bismuth therapy. Development of Potential for Microbial Overgrowth: Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole and requires treatment with an antifungal agent. As with other antibacterial drugs, use of tetracycline hydrochloride may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride and institute appropriate therapy. Photosensitivity: Photosensitivity, manifested by an exaggerated sunburn reaction, has been observed in patients taking tetracycline. Instruct patients taking bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride to avoid exposure to the sun or sun lamps. Discontinue treatment at the first evidence of skin erythema. Darkening of the Tongue and/or Black Stool: Bismuth subcitrate potassium may cause temporary and harmless darkening of the tongue and/or black stools, generally reversible within several days after treatment [see Adverse Reactions]. Stool darkening should not be confused with melena. Use in Patients with Blood Dyscrasias: Metronidazole is a nitroimidazole, and should be used with care in patients with evidence of or history of blood dyscrasia. Total and differential leukocyte counts are recommended before and after therapy. Increased Drug Plasma Concentrations in Patients with Hepatic Impairment: Patients with mild to moderate hepatic impairment should be monitored for metronidazole associated adverse events. Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is not recommended in patients with severe hepatic impairment. Cutaneous Reactions: Skin and subcutaneous disorders including Stevens-Johnson Syndrome, toxic epidermal necrolysis and dress syndrome (drug rash with eosinophilia and systemic symptoms) have been reported. Discontinue treatment at the first evidence of a cutaneous reaction. ADVERSE REACTIONS Most frequently reported adverse reactions (>5o): abnormal feces, diarrhea, nausea, and headache. DRUG INTERACTIONS Methoxyfurane: risk of fatal renal toxicity; do not co-administer. Disulfram: psychotic reactions can occur; do not take concurrently or within the last 2 weeks of disulfram. Alcohol: abdominal cramps, nausea, vomiting, headaches, and flushing can occur; do not consume during therapy and for at least 3 days afterwards. Oral contraceptives: decreased efficacy possibly resulting in pregnancy; use a different or additional form of contraception. Anticoagulants: potentiation of the anticoagulant effect; prothrombin time, international normalized ratio (INR), or other suitable anticoagulation tests should be closely monitored. Lithium: increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy. Antacids, multivitamins or dairy products: decreased absorption of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride; do not take concomitantly. Busulfan: increased busulfan serum concentrations; avoid concomitant use, monitor for busulfan toxicity. CYP inducers and CYP inhibitors: prolonged or accelerated half-life of metronidazole or concomitant medications; use with caution. INDICATION Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence. Please see Full Prescribing Information, including Boxed Warning, for bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. About Par Pharmaceutical Par Pharmaceutical develops, manufactures and markets innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patients' lives. Par, among the top leaders in the U.S. generics industry, possesses an expanding portfolio that includes sterile injectables, alternative dosage forms and other differentiated products. Par Pharmaceutical is an Endo company. Learn more at . Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, the statements by Mr. Sims, any statements relating to product launch, shipments, sales potential, quality, safety or cost. and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at relations.investor@endo.com. Company Codes: OTC-BB:ENDPQ, OTC-PINK:ENDPQ