-- NUZYRA® (omadacycline) Generated Net Product Revenue of $10.9 Million in the Third Quarter 2020; a 35% Increase Over the Prior Quarter

-- Paratek now Anticipates Full Year 2020 Total Revenue to be at the Higher End of the Previously Communicated Range of $78 to $83 Million

-- Company Lowering 2020 R&D and SG&A Expense Guidance to Approximately $120 million

-- Omadacycline Added to the FDA’s Essential Medicines List as a Medical Counter Measure Against Biological Threats 

BOSTON, Nov. 05, 2020 (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 quarter ended September 30, 2020.

“We continue to execute against our plan for NUZYRA, which is reflected in the third quarter net revenue growth of 35% over the prior quarter,” said Evan Loh, M.D., Chief Executive Officer. “Our launch trajectory continues to show NUZYRA is meaningfully outperforming other recent antibiotic launches, which we believe reflects the clinical importance of NUZYRA’s oral dosing flexibility. We are particularly pleased with this revenue growth despite an environment that saw a continued downturn in overall broad-spectrum antibiotic utilization of approximately 18% versus the same period in the prior year. NUZYRA is making a real difference in the lives of patients, and prescribers recognize that NUZYRA is an important life-saving antibiotic that addresses current and future needs in the face of the growing global threat from antibiotic resistance.”

Third Quarter 2020 NUZYRA Commercial Highlights and Update

• NUZYRA generated $10.9 million in net revenue in the third quarter of 2020, a 35% increase over the prior quarter and a 252% increase over the third quarter of 2019.
• NUZYRA revenue growth reflects continued commitment to strong execution and NUZYRA’s attributes that address unmet needs in the marketplace despite the reductions in patient traffic to physician offices and institutions of approximately 25% compared to pre-COVID-19 levels. In today’s COVID-19 environment, NUZYRA’s ability to minimize hospital stays with the oral formulation is especially relevant for many prescribers and a potentially meaningful benefit for patients.

Other Recent Highlights

• The Food and Drug Administration (FDA) review of the pre-Emergency Use Authorization (pre-EUA) application, which was submitted in February, remains ongoing. As part of the ongoing review, the supplemental mouse pharmacokinetic data requested by FDA are in the final stages of publishing at BARDA and will be submitted to FDA imminently. Based on agency discussions, we believe FDA will complete their review in a timely fashion.
• Seven posters from the NUZYRA clinical and microbiology programs were presented at the IDWeek 2020 virtual meeting in October 2020.

° In a multicenter real-world study evaluating NUZYRA, the authors concluded that NUZYRA was effective and well-tolerated in this small sample for a variety of infections, including pulmonary M. abscessus (11 patients; average treatment duration 6.4 months) and MDR/XDR A. baumannii and Enterobacteriaceae (7 patients; average duration 14 days). These data continue to reinforce the importance of additional studies to expand these encouraging clinical findings.
° Additional data presented also highlighted that the substitution of NUZYRA in place of standard of care, such as quinolones, for the treatment of patients with Community-Acquired Bacterial Pneumonia (CABP), has the potential to reduce Clostridioides difficile infection and deliver cost savings in the acute care setting.

Third Quarter 2020 Financial Results

Total revenue was $13.7 million for the third quarter of 2020, an increase of 47% versus the prior quarter and 251% versus the same quarter in the prior year.

• U.S. NUZYRA net revenue of $10.9 million for the third quarter of 2020 grew 35% versus the prior quarter and 252% versus the same quarter in the prior year.
• Government contract service and grant revenue was $2.7 million for the third quarter of 2020 versus $0.9 million in the prior quarter. No revenue was generated from the BARDA contract in 2019.

Research and development (R&D) expenses were $6.7 million for the third quarter of 2020, compared to $8.4 million for same period in the prior year. The $1.7 million decrease is primarily the result of lower clinical study costs associated with completion of the Phase 2 UTI program in 2019, partially offset by an increase in costs incurred under the BARDA contract and third-party manufacturing scale-up costs.

Selling, general and administrative (SG&A) expenses were $20.9 million for the third quarter of 2020, compared to $23.6 million for the same period in the prior year.  The $2.7 million decrease is primarily the result of lower personnel-related costs and a reduction in sales and marketing costs due to COVID-19.

Paratek reported a net loss of $20.9 million, or ($0.46) per share, for the third quarter of 2020, compared to a net loss of $32.6 million, or ($1.00) per share, for the same period in 2019.

Financial Guidance 
Paratek now anticipates its full year 2020 total revenue to be at the higher end of the previously communicated range of $78 to $83 million driven by strong NUZYRA net revenue trends.

• This revenue guidance assumes that the initial BARDA procurement of NUZYRA, valued at approximately $38 million, will occur by the end of 2020. The FDA review could be completed as early as the end of this year but may slip into the first quarter of 2021. The first procurement is expected soon after completion of the FDA review. Accordingly, revenue from the first procurement will be recognized as early as late 2020 or in the first quarter of 2021.
• 2020 R&D and SG&A expenses are now expected to be approximately $120 million compared to the prior guidance of $135 million, driven by a continued focus on operational efficiencies, and the timing of certain expenses driven by the COVID-19 pandemic, some of which will now occur in 2021.  
• Based upon our current operating plan, which includes estimated NUZYRA U.S. product revenue, BARDA procurements of NUZYRA for the SNS, and cost reimbursement under the BARDA contract, we anticipate that our existing cash, cash equivalents and marketable securities of $149.5 million, as of September 30, 2020, will provide for a cash runway through the end of 2023 with a pathway to cash flow break even.   This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement.

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

Call and Webcast
Paratek’s earnings conference call for the quarter ended September 30, 2020 will be broadcast at 4:30 p.m. EST on November 5, 2020. 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: 888-204-4368 and international investors should dial: 323-994-2093. The conference ID is 9510788. Investors can also access the call at http://public.viavid.com/index.php?id=142174.

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 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 with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

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 (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 to support the development of NUZYRA for the treatment of pulmonary anthrax.

For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

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 the impact of the COVID-19 pandemic on our revenue projections, access to hospital institutions, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA application, the status of our supplemental mouse pharmacokinetic data to support the human dose recommendation, the timing and exercise of BARDA’s procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including for U.S. onshoring and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalties and SEYSARA -backed loan funded on May 1, 2019, the strategy, execution and progression of our commercial launch of NUZYRA, our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "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 for the year ended December 31, 2019 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)

		September 30, 2020				December 31, 2019
Cash, cash equivalents and marketable securities		$	149,498			$	215,379
Total assets			198,686				251,079
Working capital			172,103				219,154
Total current liabilities			22,899				24,200
Long-term debt, less current portion			250,631				260,728
Common stock and additional paid-in capital			702,805				671,537
Accumulated deficit			(782,789	)			(711,258	)
Total stockholders’ deficit			(79,884	)			(39,647	)

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

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Product revenue, net		$	10,895			$	3,053			$	26,330			$	6,102
Government contract service revenue			785				—				1,560				—
Government contract grant revenue			1,866				—				2,303				—
Collaboration and royalty revenue			113				881				710				1,475
Net revenue		$	13,659			$	3,934			$	30,903			$	7,577
Expenses:
Cost of product revenue			2,017				958				5,724				1,731
Research and development			6,687				8,350				17,636				30,421
Selling, general and administrative			20,902				23,636				65,514				67,874
Total operating expenses			29,606				32,944				88,874				100,026
Loss from operations			(15,947	)			(29,010	)			(57,971	)			(92,449	)
Other income and expenses:
Interest income			280				992				1,347				2,873
Interest expense			(5,178	)			(4,560	)			(14,974	)			(11,777	)
Other gains (losses), net			(10	)			(36	)			67				(72	)
Net loss		$	(20,855	)		$	(32,614	)		$	(71,531	)		$	(101,425	)
Other comprehensive loss
Unrealized gain (loss) on available-for-sale securities, net of tax			(154	)			(68	)			26				276
Comprehensive loss		$	(21,009	)		$	(32,682	)		$	(71,505	)		$	(101,149	)
Basic and diluted net loss per common share		$	(0.46	)		$	(1.00	)		$	(1.64	)		$	(3.12	)
Weighted average common stock outstanding
Basic and diluted			45,483,346				32,590,454				43,591,724				32,458,010

CONTACT:

Investor and Media Relations:
Ben Strain
617-807-6688
ir@ParatekPharma.com