Market Newsdesk

TORONTO, March 13, 2023 (GLOBE NEWSWIRE) — Alamos Gold Inc. (TSX:AGI; NYSE:AGI) (“Alamos” or the “Company”) today announced that Greg Fisher, Senior Vice President of Finance has been promoted to Chief Financial Officer effective May 1, 2023. Greg will succeed Jamie Porter who will be leaving Alamos to pursue another opportunity in the mining industry. Jamie will continue in his current capacity and help support the transition until April 28, 2023.

Greg Fisher has more than 20 years of progressive experience in the mining sector, including 13 years at Alamos Gold. Greg joined Alamos in 2010 and was appointed Vice President of Finance in 2011 and Senior Vice President of Finance in 2021. During this time, he has led the finance team and has had responsibility for regulatory financial reporting, treasury management, budgeting and forecasting, tax planning and compliance, and maintenance of the Company’s internal control environment. Prior to joining Alamos in 2010, Greg was a Senior Manager at KPMG, serving mining clients in the firm’s audit practice. He graduated with an Honours Bachelor of Commerce degree from McMaster University and holds a CPA, CA designation.

“Jamie has been an invaluable member of the leadership team and family at Alamos for nearly 20 years having joined the Company in 2005 and serving as our Chief Financial Officer since 2011. I would like to thank Jamie on behalf of the entire team and Board at Alamos for his leadership, passion and financial acumen, all of which have been instrumental to our growth into a diversified intermediate gold producer, while maintaining an industry leading balance sheet. We wish him every success in his future endeavours,” said John A. McCluskey, President and Chief Executive Officer.

“Greg has been a key member of our senior management team for more than a decade having led our finance team with his financial expertise and strong leadership skills. We look forward to his ongoing leadership and financial stewardship as we deliver on our strong outlook with growing production, declining costs, and increasing profitability in the years ahead,” Mr. McCluskey added.

About Alamos

Alamos is a Canadian-based intermediate gold producer with diversified production from three operating mines in North America. This includes the Young-Davidson and Island Gold mines in northern Ontario, Canada and the Mulatos mine in Sonora State, Mexico. Additionally, the Company has a strong portfolio of growth projects, including the Phase 3+ Expansion at Island Gold, and the Lynn Lake project in Manitoba, Canada. Alamos employs more than 1,900 people and is committed to the highest standards of sustainable development. The Company’s shares are traded on the TSX and NYSE under the symbol “AGI”.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Scott K. Parsons
Senior Vice President, Investor Relations
(416) 368-9932 x 5439

The TSX and NYSE have not reviewed and do not accept responsibility for the adequacy or accuracy of this release.

 

• Q4 2022 net income was $0.63 per basic and $0.62 per diluted share and adjusted non-GAAP net income was $1.11 per basic and $1.10 per diluted share¹

• Total revenue for Q4 2022 was $60.7 million, compared to $42.3 million in Q4 2021

• FY 2022 net income was $2.76 per basic and $2.73 per diluted share and adjusted non-GAAP net income was $7.87 per basic and $7.79 per diluted share¹

• FY 2022 revenue was $316.6 million compared to $171.5 million in FY 2021

• FY 2022 net sales of PEMFEXY^® totaled $67.5 million, and were $12.1 million in Q4 2022, representing a 6% U.S. market share in community oncology at the end of Q4 2022; already captured a 10% share through February 2023; anticipate exiting Q1 2023 with 12% share²

• BENDEKA^®3 and BELRAPZO^®4 – both ready-to-dilute (“RTD”) products — combined maintained approximately 88% share of the bendamustine U.S. market for the most recent four-week period according to IQVIA compared to approximately 90% historically⁵

• Q4 2022 gross profit from the U.S. bendamustine franchise increased $2.7 million or 11% compared to Q4 2021⁶

• As of December 31, 2022, Eagle had $55.3 million in cash and cash equivalents, which is almost entirely held at JPMorgan Chase Bank, N.A. (“JPMorgan”); as of today, the Company holds less than $1.0 million in cash and cash equivalents at Silicon Valley Bank with no individual account in excess of the Federal Deposit Insurance Corporation (“FDIC”) set coverage limit

• Received U.S. Food and Drug Administration (“FDA”) approval for additional indication for PEMFEXY in combination with pembrolizumab and platinum chemotherapy and bought down future royalties on PEMFEXY profits for $15 million, eliminating royalty on first $85 million of profit and reduce royalty thereafter

• Reached settlement agreement with Accord Healthcare, Inc. related to BENDEKA (bendamustine hydrochloride)

• Announced FDA acceptance of Investigational New Drug Application (“IND”) for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the adjunct treatment of severe community-acquired bacterial pneumonia

WOODCLIFF LAKE, N.J., March 13, 2023 (GLOBE NEWSWIRE) — Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and 12 months ended December 31, 2022.

Business and Recent Highlights:

• Received approval from the U.S. Food and Drug Administration (“FDA”) for an additional indication for PEMFEXY^® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations. Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA^®.
  • Bought down future royalties on PEMFEXY profits through a one-time payment of $15 million to eliminate the royalty on the first $85 million of profit beginning October 1, 2022, and to reduce the royalty thereafter.
• During the fourth quarter of 2022, the Company reached the contractual limit for royalties paid to development partner on worldwide bendamustine profits.
• Reached a settlement agreement with Accord Healthcare, Inc. (“Accord”). Eagle had asserted its Orange Book-listed patents against Accord related to Accord’s new drug application (“NDA”) referencing BENDEKA^®. The settlement agreement provides that Accord has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances. The settlement agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
• FDA accepted the Company’s investigational new drug (“IND”) application for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the adjunct treatment of severe community-acquired bacterial pneumonia (“SCABP”). The Phase 2 study is expected to begin enrollment of approximately 276 patients with severe community-acquired pneumonia at approximately 120 sites worldwide in early 2023.
• With Enalare Therapeutics Inc. (“Enalare”), announced that the FDA granted Orphan Drug Designation (“ODD”) for the treatment of Apnea of Prematurity (“AoP”) to ENA-001, a new chemical entity with a novel mechanism of action as a respiratory stimulant. Enalare’s lead compound, ENA-001 is an investigational, one-of-a-kind NCE being developed as an agnostic respiratory stimulant for multiple patient populations experiencing acute respiratory depression. In August 2022, Eagle acquired a 17% equity stake in Enalare, with an option to purchase the remaining shares of Enalare upon achievement of specified milestones, presenting the potential to add to Eagle’s portfolio novel NCEs with strong intellectual property protection, from the mid-2030s into the 2040s, including composition of matter patents.
• Hosted Investor Day including in-depth discussions of pipeline products, newly acquired acute care products, and perspectives from Key Opinion Leaders in each clinical area.

Financial Highlights

Fourth Quarter 2022

• Total revenue for Q4 2022 was $60.7 million, compared to $42.3 million in Q4 2021.
• Q4 2022 net income was $8.2 million, or $0.63 per basic and $0.62 per diluted share, compared to net loss of $(6.2) million, or $(0.48) per basic and diluted share, in Q4 2021.
• Q4 2022 adjusted non-GAAP net income was $14.4 million, or $1.11 per basic and $1.10 per diluted share, compared to adjusted non-GAAP net income of $11.0 million, or $0.85 per basic and $0.83 per diluted share, in Q4 2021. ¹
• Cash and cash equivalents were $55.3 million, net accounts receivable was $72.4 million, and total debt was $63.8 million, as of December 31, 2022.

Full Year 2022

• Total revenue for the 12 months ended December 31, 2022 was $316.6 million, compared to $171.5 million, in 2021, an increase of 84.6%.
• Net income for the 12 months ended December 31, 2022 was $35.6 million, or $2.76 per basic and $2.73 per diluted share, compared to net loss of $(8.6) million, or $(0.66) per basic and diluted share, in 2021.
• Adjusted non-GAAP net income for the 12 months ended December 31, 2022 was $101.8 million, or $7.87 per basic and $7.79 per diluted share, compared to $22.3 million, or $1.71 per basic and $1.68 per diluted share, in 2021.¹
• From August 2016 through December 31, 2022, Eagle has repurchased $246.1 million of its common stock through its Share Repurchase Program.

“2022 was an outstanding year for Eagle, as we tripled our adjusted non-GAAP net income per diluted share over 2021. This is a significant achievement for a company of our size, and I am pleased that we accomplished this almost entirely through organic growth. During the final three months of 2022, we recorded $12 million of Pemfexy net sales and exited the quarter with a 6% U.S. market share in community oncology. We anticipate doubling this share to approximately 12% leaving the first quarter of 2023, and have already captured a 10% share through February²,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

“Looking ahead, we anticipate growth in Barhemsys and Byfavo over time now that our sales force is scaled to plan and trained. We intend to continue to manage our U.S. bendamustine franchise, support Enalare’s development of ENA-001, and advance our pipeline programs for CAL02 and landiolol. We believe our strong cash position and balance sheet provide us with the flexibility not only to support our clinical development work but also to seek a meaningful acquisition that could potentially go a long way in solidifying Eagle’s position as a diversified pharmaceutical company,” concluded Tarriff.

Fourth Quarter 2022 Financial Results

Total revenue for the three months ended December 31, 2022 was $60.7 million, as compared to $42.3 million for the three months ended December 31, 2021.

Q4 2022 RYANODEX^® net product sales were $7.2 million, compared to $6.1 million in the fourth quarter of 2021.

Q4 2022 BELRAPZO net product sales were $11.0 million, compared to $5.5 million in the fourth quarter of 2021.

Q4 2022 PEMFEXY^® net product sales were $12.1 million and vasopressin net product sales were $3.6 million.

A summary of total revenue is outlined below:

		Three Months Ended December 31,
		2022			2021
		(unaudited)			(unaudited)
Revenue (in thousands):
Product sales, net		$	37,161		$	16,158
Royalty revenue			23,538			26,162
Total revenue		$	60,699		$	42,320

Q4 2022 royalty revenue was $23.5 million, compared to $26.2 million in the prior year quarter. Full-year 2022 royalty revenue totaled $98.3 million compared to $106.5 million in 2021.

During the first quarter of 2023, Eagle provided notice to customers and the FDA that the Company is withdrawing from the vasopressin market; inventory is expected to be depleted by the end of the second quarter of 2023.

Gross margin was 67% during the fourth quarter of 2022, compared to 71% in the fourth quarter of 2021. The decrease in gross margin was driven by a change in the revenue mix, including the launch of PEMFEXY and vasopressin and amortization expense related to PEMFEXY, BARHEMSYS and BYFAVO.

R&D expense was $7.2 million for the fourth quarter of 2022, compared to $3.8 million for the fourth quarter of 2021. The increase was primarily due to higher spend of $3.9 million on CAL02.

SG&A expenses in the fourth quarter of 2022 totaled $24.2 million, compared to $20.3 million in the fourth quarter of 2021. This increase was primarily related to increased sales and marketing expense including headcount costs of $1.7 million and marketing costs of 2.1 million associated with BARHEMSYS, BYFAVO and PEMFEXY.

Net income for the fourth quarter of 2022 was $8.2 million, or $0.63 per basic and $0.62 per diluted share, compared to net loss of $(6.2) million, or $(0.48) per basic and diluted share, in the fourth quarter of 2021, primarily as a result of the factors discussed above.

Adjusted non-GAAP net income for the fourth quarter of 2022 was $14.4 million, or $1.11 per basic and $1.10 per diluted share, compared to adjusted non-GAAP net income¹ of $11.0 million, or $0.85 per basic and $0.83 per diluted share, in the fourth quarter of 2021.

Full Year 2022 Financial Results

Total revenue for the year ended December 31, 2022 was $316.6 million, as compared to $171.5 million for the year ended December 31, 2021. A summary of total revenue is outlined below:

		Twelve Months Ended December 31,
		2022			2021
Revenue (in thousands):
Product sales, net		$	214,536		$	65,023
Royalty revenue			98,266			106,523
License and other revenue			3,808		—
Total revenue		$	316,610		$	171,546

Net revenues increased by $145.1 million to $316.6 million in the year ended December 31, 2022 compared to $171.5 million in 2021, primarily driven by the launches of PEMFEXY and vasopressin, increases in product sales of BELRAPZO of $9.9 million and Ryanodex of $4.9 million, the acquisition of BARHEMSYS and BYFAVO, and increases in TREAKISYM royalties of $4.1 million, partially offset by a decrease in royalties of BENDEKA of $12.3 million. During 2022, we recorded $3.8 million of other revenue for a cumulative sales milestone on sales of TREAKISYM in Japan by our marketing partner, SymBio.

Gross margin was 70% for the full year 2022, as compared to 75% for 2021. The decrease in gross margin was driven by a change in the revenue mix, including the launch of PEMFEXY and vasopressin and amortization expense related to PEMFEXY, BARHEMSYS and BYFAVO.

R&D expense decreased to $34.1 million in 2022, compared to $51.3 million in 2021, primarily reflecting the non-recurrence of a $10.0 million upfront payment related to our license agreement with Combioxin SA for CAL02, a $5.0 million upfront payment related to our licensing agreement with AOP Orphan for landiolol, lower headcount cost of $1.3 million, lower spend of vasopressin of $7.6 million, RYANODEX and EA111 of $3.1 million and PEMFEXY of $2.2 million. This was partially offset by $11.0 million of CMC and clinical expenses on our CAL02 program.

Excluding stock-based compensation and other non-cash items, adjusted non-GAAP R&D expense¹ for 2022 was $31.5 million.

SG&A expenses increased by $31.3 million to $106.6 million in 2022, compared to $75.3 million in 2021. The increase primarily reflects $16.6 million of higher professional fees which primarily resulted from our Acacia Pharma Group plc (“Acacia”) and Enalare transactions, $6.9 million of severance related to the acquisition of Acacia, and increased sales and marketing expense which includes increased headcount costs of $3.8 million and increased marketing costs of 5.9 million associated with BARHEMSYS, BYFAVO and PEMFEXY. This was partially offset by $2.9 million of lower stock-based compensation expense.

Net income for the year ended December 31, 2022 was $35.6 million, or $2.76 per basic and $2.73 per diluted share, as compared to net loss of $(8.6) million or $(0.66) per basic and diluted share for the year ended December 31, 2021, as a result of the factors discussed above.

Adjusted non-GAAP net income for the year ended December 31, 2022 was $101.8 million, or $7.87 per basic and $7.79 per diluted share, compared to adjusted non-GAAP net income¹ of $22.3 million, or $1.71 per basic and $1.68 per diluted share, for 2021.¹

2023 Guidance

• Adjusted EBITDA of $74.0-$80.0 million¹
• Adjusted non-GAAP earnings per share of $4.20-$4.53¹
• Adjusted non-GAAP R&D expense of $41.0-$45.0 million¹
• Adjusted non-GAAP SG&A expense of $86.0-$90.0 million¹

Liquidity

As of December 31, 2022, Eagle had $55.3 million in cash and cash equivalents, $72.4 million in accounts receivable, net, and $63.8 million in outstanding debt on the Company’s $150 million credit facility with JPMorgan. Therefore, as of December 31, 2022, Eagle had cash and cash equivalents plus accounts receivables, net of $127.7 million.

In 2022, Eagle repurchased $18.0 million of its common stock as part of its Share Repurchase Program. From August 2016 through December 31, 2022, Eagle has repurchased $246.1 million of its common stock.

Conference Call

As previously announced, Eagle management will host its fourth quarter 2022 conference call as follows:

Date		March 13, 2023
Time		8:30 A.M. ET
Toll free (U.S.)		800-445-7795
International		785-424-1789
Webcast (live and replay)		www.eagleus.com, under the “Investor + News” section

A replay of the conference call will be available for two weeks after the call’s completion by dialing 800-839-4199 (U.S.) or 402-220-2989 (International) and entering conference call ID EGRXQ422. The webcast will be archived for 30 days at the aforementioned URL.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include vasopressin, PEMFEXY^®, RYANODEX^®, BENDEKA^®, BELRAPZO^®, TREAKISYM^® (Japan), and BYFAVO^® and BARHEMSYS^® through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “could,” “should,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “future,” “believe,” “guidance,” “project,” “estimate,” “intend,” “advance,” “continue” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements with respect to: the potential benefits of FDA approval of an additional indication for PEMFEXY^® in combination with pembrolizumab and platinum chemotherapy; the potential benefits of reduced royalty payments on PEMFEXY; the development of, potential benefits of and potential FDA submission for ENA-001; the achievement of milestones and deliverables; the Company’s ability to manage its bendamustine franchise; the potential further investment by the Company in Enalare and the Company’s development programs, products and pipeline and the potential exercise of the Company’s option to acquire all of Enalare’s outstanding shares; the potential use of ENA-001 to help preterm infants with respiratory conditions; the ability of ENA-001 and other products and product candidates to address unmet clinical needs, including for patients with post-operative respiratory depression and in combatting community drug overdose; the Company’s financial projections and guidance, including anticipated financial performance for 2023, including expected adjusted EBITDA, adjusted non-GAAP earnings per share and adjusted non-GAAP R&D and adjusted non-GAAP SG&A expense; the potential benefits and commercial opportunity of Enalare’s product candidates; expected continued earnings growth and anticipated deployment of cash to fund clinical development and potential strategic transaction; the potential for the Company to transition into a diversified pharmaceutical company with a portfolio of branded, first-in-class assets and to utilize legacy products; the potential of CAL02 to be a first-in-class broad-spectrum anti-virulence agent for the treatment of severe community-acquired bacterial pneumonia; the Company’s ability to pursue additional potential transactions to further diversify its product portfolio and pipeline on favorable terms or at all; the Company’s ability to obtain and maintain regulatory approval of its products and product candidates; the Company’s clinical development plan for its product candidates, including the number and timing of development initiatives or new indications for the Company’s product candidates; the design, timing and ability to enroll patients in clinical trials, including for CAL02; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company’s or its partner’s product candidates, including landiolol, CAL02 and Enalare’s ENA-001; the progress and success of the Company’s launch of any products, including vasopressin and PEMFEXY; the addressable market size for, and the ability of the Company to successfully commercialize, its product candidates, including vasopressin and PEMFEXY, and expectations with respect to growth of market share; the ability of BARHEMSYS, BYFAVO, landiolol and other products and product candidates to address unmet clinical needs; the potential market opportunity for the Company’s products or product candidates, including for BARHEMSYS, BYFAVO and landiolol; the period of marketing exclusivity for any of the Company’s products or product candidates; the resolution of patent litigation and all related settlement terms, including the date of market entry and the potential for earlier market entry under certain circumstances; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company’s product candidates and the Company’s ability to maintain regulatory approval of its products and product candidates; the Company’s clinical development plan for the product candidates in its portfolio; the implementation of certain healthcare reform measures; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the success of the Company’s collaborations with its strategic partners and the timing and results of these partners’ preclinical studies and clinical trials, and the Company’s potential earnings potential through such collaborations; the ability of the Company’s executive team to execute on the Company’s strategy and to utilize its cash and other assets to increase shareholder value; and the ability of the Company’s product candidates to deliver value to stockholders; the Company’s ability to deliver value in 2023 and over the long term; the Company’s ability to sustain and further its growth; the Company’s ability to effectively manage and control expenses in line with its budget; and the Company’s plans and ability to advance the products in its pipeline; potential opportunities for, and the Company’s ability to complete, business development transactions, in a timely manner, on favorable terms to the Company, or at all; the sufficiency of the Company’s cash flows and capital resources; and the Company’s ability to achieve expected future financial performance and results. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks and uncertainties include, but are not limited to: the risk that the anticipated benefits of the Company’s acquisition of Acacia are not realized; the ability of Enalare to achieve milestones and deliverables under the BARDA agreement and achieve successful results in the development of ENA-001 and the Company’s ability to exercise its option to acquire the remaining outstanding share capital of Enalare; the impacts of the COVID-19 pandemic and geopolitical events such as the conflict in Ukraine, including disruption or impact in the sales of the Company’s marketed products, interruptions or other adverse effects to clinical trials, delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems, disruption in the operations of the Company’s third party partners and disruption of the global economy, and the overall impact of the COVID-19 pandemic or other events on the Company’s business, financial condition and results of operations; macroeconomic conditions, including rising inflation and uncertain credit and financial markets; whether the Company will incur unforeseen expenses or liabilities or other market factors; whether the Company will successfully implement its development plan for its product candidates; delay in or failure to obtain regulatory approval of the Company’s or its partners’ product candidates; whether the Company can successfully market and commercialize its product candidates; the success of the Company’s relationships with its partners; the availability and pricing of third party sourced products and materials; the outcome of litigation involving any of its products or that may have an impact on any of our products; successful compliance with the FDA and other governmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; general economic conditions, including the potential adverse effects of public health issues, including the COVID-19 pandemic and geopolitical events, on economic activity and the performance of the financial markets generally; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology companies and the potential for competition from generic entrants into the market; the risks inherent in the early stages of drug development and in conducting clinical trials; and any unanticipated factors in addition to the foregoing that may impact the Company’s financial and business projections and guidance and may cause the Company’s actual results and outcomes to materially differ from its projections and guidance; and those risks and uncertainties identified in the “Risk Factors” sections of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the Securities and Exchange Commission (the “SEC”) on November 9, 2022, and its other subsequent filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Readers are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Non-GAAP Financial Performance Measures

In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted non-GAAP net income, adjusted non-GAAP earnings per share, adjusted non-GAAP R&D expense and adjusted non-GAAP SG&A expense and projected adjusted non-GAAP R&D expense, adjusted EBITDA and adjusted non-GAAP earnings per share. The Company believes these measures provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information.

Beginning in the fourth quarter of 2022, Eagle no longer excludes expense for In-Process Research & Development from its non-GAAP results. Historically, the company excluded these charges. These changes have been made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect these changes.

Adjusted non-GAAP net income and related earnings per share information excludes amortization expense, stock-based compensation expense, depreciation expense, severance, acquisition related costs, legal settlement, debt issuance costs, non-cash interest expense, fair value adjustments on equity investment, convertible promissory note related adjustments, fair value adjustments related to derivative instruments, foreign currency exchange loss, gain on euro debt, inventory step-up and the tax effect of these adjustments.

Adjusted EBITDA excludes interest expense net of interest income, income tax provision, depreciation and amortization expense, stock-based compensation expense, fair value adjustments on equity investment, convertible promissory note related credit losses, fair value adjustments related to derivative instruments, foreign currency exchange loss, gain on euro debt, legal settlement, acquisition related costs, inventory step-up and debt issuance cost and severance.

Adjusted non-GAAP R&D expense excludes stock-based compensation expense, depreciation expense and severance.

Adjusted non-GAAP SG&A expense excludes stock-based compensation expense, depreciation expense, severance, acquisition related costs, amortization expense, legal settlement and debt issuance costs.

The Company believes the use of non-GAAP financial measures helps indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding projected operating performance. Non-GAAP financial measures provide the Company and its investors with an indication of the Company’s baseline performance before items that are considered by the Company not to be reflective of the Company’s ongoing results. See the attached reconciliation tables for details of the amounts excluded and included to arrive at certain of the non-GAAP financial measures.

Investors should note that reconciliations of the forward-looking or projected non-GAAP financial measures included in this press release to their most comparable GAAP financial measures cannot be provided because the Company cannot do so without unreasonable efforts due to the unavailability of information needed to calculate the reconciling items and the variability, complexity, and limited visibility of comparable GAAP measures, and the reconciling items that would be excluded from the non-GAAP financial measures in the future. Likewise, the Company is unable to provide projected GAAP financial measures. GAAP projections and reconciliations of the components of projected adjusted EBITDA, adjusted non-GAAP R&D expenses, and adjusted non-GAAP earning per share to their most comparable GAAP financial measures are not provided because the quantification of projected GAAP R&D expenses, net income and earnings per share and the reconciling items between projected GAAP to adjusted EBITDA, adjusted non-GAAP R&D expenses, and adjusted non-GAAP earnings per share cannot be reasonably calculated or predicted at this time without unreasonable efforts. For example, with respect to GAAP net income and R&D Expense, the Company is not able to calculate the favorable or unfavorable expenses related to the fair value adjustments on equity investments and derivative instruments primarily due to nature of these transactions. Such unavailable information could be significant such that actual GAAP net income, R&D expenses, and earnings per share would vary significantly from projected GAAP and adjusted EBITDA, adjusted non-GAAP R&D expenses, and adjusted non-GAAP earnings per share.

These non-GAAP financial measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its non-GAAP financial measures; and the Company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. For example, commencing in 2023, the Company no longer excludes expense of acquired in-process research & development from the Company’s adjusted non-GAAP net income or adjusted EBITDA, their line item components, and non-GAAP earnings per share. For purposes of comparability, non-GAAP adjusted financial measures for the three and twelve months ended December 31, 2021 have been updated to reflect this change. Accordingly, such expenses are not excluded from its non-GAAP financial measures for the three and twelve months ended December 31, 2022 and 2021, as detailed in the reconciliation tables that follow, or from 2023 non-GAAP adjusted net income and adjusted non-GAAP earnings per share guidance. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. The Company strongly encourages investors to review its consolidated financial statements and publicly-filed reports in their entirety and cautions investors that the non-GAAP financial measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures.

Investor Relations for Eagle Pharmaceuticals, Inc.:

Lisa M. Wilson        
In-Site Communications, Inc.
T: 212-452-2793
E: [email protected]

— Financial tables follow —

EAGLE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
		December 31, 2022				December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents		$	55,321			$	97,659
Accounts receivable, net			72,439				41,149
Inventories			47,794				21,908
Prepaid expenses and other current assets			13,200				11,890
Total current assets			188,754				172,606
Property and equipment, net			1,168				1,636
Intangible assets, net			118,327				10,671
Goodwill			45,033				39,743
Deferred tax asset, net			27,146				18,798
Other assets			25,732				10,278
Total assets		$	406,160			$	253,732
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	18,993			$	16,431
Accrued expenses and other liabilities			85,844				32,338
Short-term debt			6,250				25,607
Total current liabilities			111,087				74,376
Other long-term liabilities			5,297				2,903
Long-term debt			56,216				—
Total liabilities			172,600				77,279
Commitments and Contingencies
Stockholders’ equity:
Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as December 31, 2022 and 2021			—				—
Common stock, $0.001 par value; 50,000,000 shares authorized; 17,569,375 and 16,903,034 shares issued as of December 31, 2022 and 2021, respectively			18				17
Additional paid in capital			366,265				325,779
Accumulated other comprehensive loss			(1,112	)			(94	)
Retained earnings			111,504				75,862
Treasury stock, at cost, 4,552,730 and 4,111,622 shares as of December 31, 2022 and 2021, respectively			(243,115	)			(225,111	)
Total stockholders’ equity			233,560				176,453
Total liabilities and stockholders’ equity		$	406,160			$	253,732

EAGLE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
		Three Months Ended December 31,								Year Ended December 31,
			2022				2021				2022				2021
		(unaudited)				(unaudited)
Revenue:
Product sales, net		$	37,161			$	16,158			$	214,536			$	65,023
Royalty revenue			23,538				26,162				98,266				106,523
License and other revenue			—				—				3,808				—
Total revenue			60,699				42,320				316,610				171,546
Operating expenses:
Cost of product sales			18,242				9,693				85,458				31,528
Cost of royalty revenue			1,624				2,616				9,478				10,652
Research and development			7,217				3,787				34,088				51,275
Selling, general and administrative			24,150				20,325				106,626				75,322
Total operating expenses			51,233				36,421				235,650				168,777
Income from operations			9,466				5,899				80,960				2,769
Interest income			317				165				271				560
Interest expense			(1,980	)			(395	)			(4,045	)			(1,635	)
Other income (expense)			5,501				(4,445	)			(15,753	)			(6,242	)
Total other income (expense), net			3,838				(4,675	)			(19,527	)			(7,317	)
Income (loss) before income tax provision			13,304				1,224				61,433				(4,548	)
Income tax provision			(5,139	)			(7,420	)			(25,791	)			(4,079	)
Net income (loss)		$	8,165			$	(6,196	)		$	35,642			$	(8,627	)
Earnings (loss) per common share:
Basic		$	0.63			$	(0.48	)		$	2.76			$	(0.66	)
Diluted		$	0.62			$	(0.48	)		$	2.73			$	(0.66	)
Weighted average number of common shares outstanding:
Basic			13,015,976				12,896,471				12,933,896				13,051,095
Diluted			13,124,218				12,896,471				13,065,494				13,051,095

EAGLE PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME AND
ADJUSTED NON-GAAP EARNINGS PER SHARE (UNAUDITED)
(In thousands, except share and per share amounts)
		Three Months Ended December 31,								Twelve Months Ended December 31,
			2022				2021				2022				2021
Net income (loss) – GAAP		$	8,165			$	(6,196	)		$	35,642			$	(8,627	)
Adjustments:
Cost of product revenues:
Amortization expense			5,492				675				11,378				1,578
Research and development:
Stock-based compensation expense			606				505				2,450				2,682
Depreciation expense			33				56				167				220
Severance			—				260				—				534
Selling, general and administrative:
Stock-based compensation expense			3,513				4,177				14,001				16,873
Depreciation expense			105				133				479				544
Severance			73				1,216				8,451				1,550
Aquisition related costs			285				—				13,122				—
Amortization expense			—				203				—				1,418
Legal settlement			—				—				300				—
Debt issuance costs			258				—				258				—
Other:
Non-cash interest expense			926				118				2,078				472
Fair value adjustments on equity investment			1,249				4,270				4,457				6,170
Convertible promissory note related adjustments			—				562				4,646				610
Fair value adjustments related to derivative instruments			710				(432	)			7,965				(686	)
Foreign currency exchange loss			(7,196	)			—				(647	)			—
Gain on euro debt			(264	)			—				(264	)			—
Inventory step-up			154				—				546				—
Tax effect of the non-GAAP adjustments			322				5,403				(3,237	)			(1,054	)
Adjusted non-GAAP net income		$	14,431			$	10,950			$	101,792			$	22,284
Earnings (loss) per share:
Basic		$	0.63			$	(0.48	)		$	2.76			$	(0.66	)
Diluted		$	0.62			$	(0.48	)		$	2.73			$	(0.66	)
Weighted average number of common shares outstanding:
Basic			13,015,976				12,896,471				12,933,896				13,051,095
Diluted			13,124,218				12,896,471				13,065,494				13,051,095
Adjusted non-GAAP earnings per share:
Basic		$	1.11			$	0.85			$	7.87			$	1.71
Diluted		$	1.10			$	0.83			$	7.79			$	1.68
Weighted average number of common shares outstanding:
Basic			13,015,976				12,896,471				12,933,896				13,051,095
Diluted			13,124,218				13,203,666				13,065,494				13,265,181

EAGLE PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA (UNAUDITED)
(In thousands)
			Three Months Ended December 31,								Twelve Months Ended December 31,
				2022				2021				2022				2021
Net income (loss) – GAAP			$	8,165			$	(6,196	)		$	35,642			$	(8,627	)
Add back:
	Interest expense, net of interest income			1,663				230				3,774				1,075
	Income tax provision			5,139				7,420				25,791				4,079
	Depreciation and amortization expense			5,630				1,067				12,024				3,760
Add back:
	Stock-based compensation expense			4,119				4,682				16,451				19,555
	Fair value adjustments on equity investment			1,249				4,270				4,457				6,170
	Convertible promissory note related adjustments			—				608				4,242				758
	Fair value adjustments related to derivative instruments			710				(432	)			7,965				(686	)
	Foreign currency exchange loss			(7,196	)			—				(647	)			—
	Gain on euro debt			(264	)			—				(264	)			—
	Legal Settlement			—				—				300				—
	Aquisition related costs			285				—				13,122				—
	Inventory step-up			154				—				546				—
	Debt issuance cost			258				—				258				—
	Severance			73				1,476				8,451				2,084
Adjusted Non-GAAP EBITDA			$	19,985			$	13,125			$	132,112			$	28,168

EAGLE PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP
RESEARCH AND DEVELOPMENT AND SELLING, GENERAL AND ADMINISTRATIVE (UNAUDITED)
(In thousands)
			Three Months Ended December 31,						Twelve Months Ended December 31,
				2022			2021			2022			2021
Research and development – GAAP			$	7,217		$	3,787		$	34,088		$	51,275
Add back:
	Stock-based compensation expense			606			505			2,450			2,682
	Depreciation expense			33			56			167			220
	Severance			—			260			—			534
Research and development – Non-GAAP			$	6,578		$	2,966		$	31,471		$	47,839
			Three Months Ended December 31,						Twelve Months Ended December 31,
				2022			2021			2022			2021
Selling, general and administrative – GAAP			$	24,150		$	20,325		$	106,626		$	75,322
Add back:
	Stock-based compensation expense			3,513			4,177			14,001			16,873
	Depreciation expense			105			133			479			544
	Severance			73			1,216			8,451			1,550
	Aquisition related costs			285			—			13,122			—
	Amortization expense			—			203			—			1,418
	Legal settlement			—			—			300			—
	Debt issuance costs			258			—			258			—
Selling, general and administrative – Non-GAAP			$	19,916		$	14,596		$	70,015		$	54,937

Important Safety Information

for BARHEMSYS® (amisulpride)

⁷

Injection

Contraindication

BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation

BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.

Avoid BARHEMSYS in patients with congenital long QT syndrome and in patients taking droperidol.

Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions

Common adverse reactions reported in ≥ 2% of adult patients who received BARHEMSYS 5 mg (n=748) and at a higher rate than placebo (n=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).

Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of BARHEMSYS-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.

The most common adverse reaction, reported in ≥ 2% of adult patients who received BARHEMSYS 10 mg (n=418) and at a higher rate than placebo (n=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Use in Specific Populations

Lactation

Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.

BARHEMSYS may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after BARHEMSYS treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.

To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of BARHEMSYS.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment

Avoid BARHEMSYS in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride in patients with severe renal impairment have not been adequately studied in clinical trials. Amisulpride is known to be substantially excreted by the kidneys, and patients with severe renal impairment may have increased systemic exposure and an increased risk of adverse reactions.

No dosage adjustment is necessary in patients with mild to moderate renal impairment

(eGFR ≥ 30 mL/min/1.73 m2).

Drug Interactions

• BARHEMSYS causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of BARHEMSYS in patients taking droperidol.
• ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
• Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS. Avoid using levodopa with BARHEMSYS.

Important Safety Information

for BYFAVO™ (remimazolam)
⁸
Injection

Indications

BYFAVO is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Important Safety Information

WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS

Personnel and Equipment for Monitoring and Resuscitation

• Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. 
• Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. 
• BYFAVO has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period.
• Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO.

Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics

Concomitant use of benzodiazepines, including BYFAVO, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation.

Contraindication 

BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.

Personnel and Equipment for Monitoring and Resuscitation

Clinically notable hypoxia, bradycardia, and hypotension were observed in Phase 3 studies of BYFAVO. Continuously monitor vital signs during sedation and through the recovery period. Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO. Consider the potential for worsened cardiorespiratory depression prior to using BYFAVO concomitantly with other drugs that have the same potential (e.g., opioid analgesics or other sedative-hypnotics). Administer supplemental oxygen to sedated patients through the recovery period. A benzodiazepine reversal agent (flumazenil) should be immediately available during administration of BYFAVO.

Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics

Concomitant use of BYFAVO and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of IV BYFAVO can be accentuated when administered with other CNS depressant medications (eg, other benzodiazepines and propofol). Titrate the dose of BYFAVO when administered with opioid analgesics and sedative-hypnotics to the desired clinical response. Continuously monitor sedated patients for hypotension, airway obstruction, hypoventilation, apnea, and oxygen desaturation. These cardiorespiratory effects may be more likely to occur in patients with obstructive sleep apnea, the elderly, and ASA-PS class III or IV patients.

Hypersensitivity Reactions 

BYFAVO contains dextran 40, which can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis. BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. 

Neonatal Sedation

Use of benzodiazepines during the later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) in the neonate. Observe newborns for signs of sedation and manage accordingly.

Pediatric Neurotoxicity

Published animal studies demonstrate that anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of this is not clear. However, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life but may extend out to approximately 3 years of age in humans. 

Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.

Adverse Reactions

The most common adverse reactions reported in >10% of patients (N=630) receiving BYFAVO 5-30 mg (total dose) and undergoing colonoscopy (two studies) or bronchoscopy (one study) were: hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.

Use in Specific Populations

Pregnancy

There are no data on the specific effects of BYFAVO on pregnancy. Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation and respiratory depression.

Lactation

Monitor infants exposed to BYFAVO through breast milk for sedation, respiratory depression, and feeding problems. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 5 hours after BYFAVO administration. 

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. BYFAVO should not be used in patients less than 18 years of age.

Geriatric Use

No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, there is a potential for greater sensitivity (eg, faster onset, oversedation, confusion) in some older individuals. Administer supplemental doses of BYFAVO slowly to achieve the level of sedation required and monitor all patients closely for cardiorespiratory complications.

Hepatic Impairment

In patients with severe hepatic impairment, the dose of BYFAVO should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications.

Abuse and Dependence

BYFAVO is a federally controlled substance (CIV) because it contains remimazolam which has the potential for abuse and physical dependence.

¹ Adjusted non-GAAP net income, adjusted non-GAAP earnings per share, adjusted non-GAAP R&D expense and adjusted non-GAAP SG&A expense are non-GAAP financial measures. For descriptions and reconciliations of these non-GAAP financial measures to their most comparable GAAP financial measures, please see below and the tables at the end of this press release.
² Based on IQVIA SMART-US weekly volume data and internal data.
³ https://www.bendekahcp.com/globalassets/bendeka-hcp/prescribinginformation.pdf
⁴https://belrapzo.com/prescribing-information.pdf
⁵ IQVIA SMART-US weekly volume data for 2/2/23 – 2/24/23 and 2022 historic IQVIA data.
⁶ Gross profit includes all U.S. revenues generated by bendamustine products and all associated costs of sales including royalty expense on a GAAP basis.
⁷https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf 
⁸https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf

MONACO, March 13, 2023 (GLOBE NEWSWIRE) — Scorpio Tankers Inc. (NYSE: STNG) (“Scorpio Tankers” or the “Company”) announced today that it has exercised the purchase options on six ships.

The Company has given notice to exercise its purchase options on two 2016 built LR2 product tankers (STI Grace and STI Jermyn), one 2019 built LR2 product tanker (STI Lavender), two 2019 built MR product tankers (STI Magnetic and STI Marshall) and one 2020 built MR product tanker (STI Miracle).  The leases bear interest at LIBOR plus a margin of 3.50% per annum.  The purchase, which is expected to occur in May 2023, will result in a debt reduction of $149.8 million for the Company.

About Scorpio Tankers Inc.

Scorpio Tankers Inc. is a provider of marine transportation of petroleum products worldwide. Scorpio Tankers Inc. currently owns, finance leases or bareboat charters-in 113 product tankers (39 LR2 tankers, 60 MR tankers and 14 Handymax tankers) with an average age of 7.1 years. Additional information about the Company is available at the Company’s website www.scorpiotankers.com, which is not a part of this press release.

Forward-Looking Statements

Matters discussed in this press release may constitute forward‐looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward‐looking statements in order to encourage companies to provide prospective information about their business. Forward‐looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “target,” “project,” “likely,” “may,” “will,” “would,” “could” and similar expressions identify forward‐looking statements.

The forward‐looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in the Company’s records and other data available from third parties. Although management believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, there can be no assurance that the Company will achieve or accomplish these expectations, beliefs or projections. The Company undertakes no obligation, and specifically declines any obligation, except as required by law, to publicly update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise. In addition to these important factors, other important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward‐looking statements include unforeseen liabilities, future capital expenditures, revenues, expenses, earnings, synergies, economic performance, indebtedness, financial condition, losses, future prospects, business and management strategies for the management, the length and severity of the ongoing novel coronavirus (COVID-19) outbreak, including its effect on demand for petroleum products and the transportation thereof, expansion and growth of the Company’s operations, risks relating to the integration of assets or operations of entities that it has or may in the future acquire and the possibility that the anticipated synergies and other benefits of such acquisitions may not be realized within expected timeframes or at all, the failure of counterparties to fully perform their contracts with the Company, the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and vessel values, changes in demand for tanker vessel capacity, changes in the Company’s operating expenses, including bunker prices, drydocking and insurance costs, the market for the Company’s vessels, availability of financing and refinancing, charter counterparty performance, ability to obtain financing and comply with covenants in such financing arrangements, changes in governmental rules and regulations or actions taken by regulatory authorities, potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents or political events, vessels breakdowns and instances of off‐hires, and other factors. Please see the Company’s filings with the SEC for a more complete discussion of certain of these and other risks and uncertainties.

Contact Information

Scorpio Tankers Inc.
James Doyle – Head of Corporate Development & Investor Relations
Tel: +1 646-432-1678
Email: [email protected]

Go-to-Market Solution Provides Full Commercial Support for the First, True Entire Active-Day Medication Designed to treat ADHD

Indegene Model Geared for Efficient National Commercial Launch in Multibillion-Dollar ADHD Market

KANSAS CITY, Kan. and PRINCETON, N.J., March 13, 2023 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, and Indegene, a digital-first, life sciences commercialization company, today announced a joint commercialization agreement to provide commercial support for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA).

The agreement spans cross-functional services through an omnichannel marketing approach uniquely designed to successfully manage pre-commercial support during Cingulate’s Phase 3 clinical trials and to effectively commercialize CTx-1301 nationwide following potential FDA approval. Cingulate recently announced the initiation of its first Phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to assess onset and duration, with results expected in the third quarter of 2023. In addition, the Company plans to initiate its pivotal Phase 3 trial, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023.

“This agreement provides a clear path to commercialize CTx-1301, upon FDA approval, designed specifically to tackle the unmet needs of this $20 billion market by providing the first true, entire-active-day treatment for ADHD. But the clinical success of a potential treatment can only be realized with commercial excellence, making this partnership between Cingulate and Indegene a critical step for our Company,” said Shane J Schaffer, Chairman and CEO, Cingulate. “We believe Indegene provides a comprehensive solution combining sales professionals and field medical personnel, and its AI-driven omnichannel marketing suite is unparrellled in the industry, making them the right partner at the right time to help Cingulate redefine the ADHD treatment paradigm. Additionally, this allows Cingulate to focus on clinical development by reducing the internal resources and risks associated with building out these functional areas.”

Cingulate’s comprehensive agreement with Indegene covers most facets of the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support. The partnership is focused on driving revenue and is designed to ensure predictable cash outflow and continues through three years post-launch of CTx-1301.

“We believe the unique attributes of CTx-1301 differentiate Cingulate’s product from other available products in the market, which aligns well to Indegene’s omnichannel approach to raising awareness among physicians and patients,” said Timothy Moore, Senior Vice President of Emerging Biotech at Indegene.

Data show that Indegene’s omnichannel marketing solution has a greater impact than field sales representatives alone, with better customer experiences at a fraction of the cost of the more traditional model. Utilizing proprietary artificial intelligence (AI) and data to reach health care professional (HCP) targets in the most effective and efficient manner, Indegene leverages a large database of HCPs and HCP interactions to develop a curated sales and marketing strategy. An algorithm then learns and adapts in real-time to deliver content that ultimately changes prescribing behaviors.

“We believe the ability to deploy Indegene’s range of digital best practices and new communications channels will play a large role in the pre-launch preparation, and enable Cingulate to immediately tap into the proven market access, sales force effectiveness and medical commercialization operations critical to a successful launch,” Moore added. “We have worked with 19 of the top 20 global pharmaceutical companies, and this joint commercialization agreement expands Indegene’s services to an emerging growth company, positioning Cingulate for success in the event CTx-1301 is approved by the FDA.”

Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, there is currently no available medication offering a single oral dose that provides patients entire active-day efficacy. CTx-1301 aims to be the first medication to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours while improving patient tolerability.

About CTx-1301

Cingulate’s lead candidate, CTx-1301, utilizes the Company’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.

While stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains, providing patients entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

The company has initiated the first of two Phase 3 clinical studies of CTx-1301 to support its NDA submission. The pivotal, Phase 3 fixed-dose trial in children and adolescents is scheduled to begin in mid-2023.

About Precision Timed Release™ (PTR™) Platform Technology

Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using the Company’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma.

Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies.

For more information visit Cingulate.com/technology.

About Cingulate Inc.

Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR™ drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.

About Indegene

We are a digital-first, life sciences commercialization company. We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready. To learn more, please visit www.indegene.com

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature.

These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 28, 2022. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Investor Relations:

Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
[email protected]
(913) 942-2301

Matt Kreps
Darrow Associates
[email protected]
214-597-8200

Media Relations:

Melysa Weible

Elixir Health Public Relations
[email protected]
201-723-5805

Yadunandan K V

Director – Corporate Communications, Indegene
[email protected]

CING-US-120-0324

Go-to-Market Solution Provides Full Commercial Support for the First, True Entire Active-Day Medication Designed to treat ADHD

Indegene Model Geared for Efficient National Commercial Launch in Multibillion-Dollar ADHD Market

KANSAS CITY, Kan. and PRINCETON, N.J., March 13, 2023 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, and Indegene, a digital-first, life sciences commercialization company, today announced a joint commercialization agreement to provide commercial support for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA).

The agreement spans cross-functional services through an omnichannel marketing approach uniquely designed to successfully manage pre-commercial support during Cingulate’s Phase 3 clinical trials and to effectively commercialize CTx-1301 nationwide following potential FDA approval. Cingulate recently announced the initiation of its first Phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to assess onset and duration, with results expected in the third quarter of 2023. In addition, the Company plans to initiate its pivotal Phase 3 trial, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023.

“This agreement provides a clear path to commercialize CTx-1301, upon FDA approval, designed specifically to tackle the unmet needs of this $20 billion market by providing the first true, entire-active-day treatment for ADHD. But the clinical success of a potential treatment can only be realized with commercial excellence, making this partnership between Cingulate and Indegene a critical step for our Company,” said Shane J Schaffer, Chairman and CEO, Cingulate. “We believe Indegene provides a comprehensive solution combining sales professionals and field medical personnel, and its AI-driven omnichannel marketing suite is unparalleled in the industry, making them the right partner at the right time to help Cingulate redefine the ADHD treatment paradigm. Additionally, this allows Cingulate to focus on clinical development by reducing the internal resources and risks associated with building out these functional areas.”

Cingulate’s comprehensive agreement with Indegene covers most facets of the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support. The partnership is focused on driving revenue and is designed to ensure predictable cash outflow and continues through three years post-launch of CTx-1301.

“We believe the unique attributes of CTx-1301 differentiate Cingulate’s product from other available products in the market, which aligns well to Indegene’s omnichannel approach to raising awareness among physicians and patients,” said Timothy Moore, Senior Vice President of Emerging Biotech at Indegene.

Data show that Indegene’s omnichannel marketing solution has a greater impact than field sales representatives alone, with better customer experiences at a fraction of the cost of the more traditional model. Utilizing proprietary artificial intelligence (AI) and data to reach health care professional (HCP) targets in the most effective and efficient manner, Indegene leverages a large database of HCPs and HCP interactions to develop a curated sales and marketing strategy. An algorithm then learns and adapts in real-time to deliver content that ultimately changes prescribing behaviors.

“We believe the ability to deploy Indegene’s range of digital best practices and new communications channels will play a large role in the pre-launch preparation, and enable Cingulate to immediately tap into the proven market access, sales force effectiveness and medical commercialization operations critical to a successful launch,” Moore added. “We have worked with 19 of the top 20 global pharmaceutical companies, and this joint commercialization agreement expands Indegene’s services to an emerging growth company, positioning Cingulate for success in the event CTx-1301 is approved by the FDA.”

Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, there is currently no available medication offering a single oral dose that provides patients entire active-day efficacy. CTx-1301 aims to be the first medication to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours while improving patient tolerability.

About CTx-1301

Cingulate’s lead candidate, CTx-1301, utilizes the Company’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.

While stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains, providing patients entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

The company has initiated the first of two Phase 3 clinical studies of CTx-1301 to support its NDA submission. The pivotal, Phase 3 fixed-dose trial in children and adolescents is scheduled to begin in mid-2023.

About Precision Timed Release™ (PTR™) Platform Technology

Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using the Company’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma.

Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies.

For more information visit Cingulate.com/technology.

About Cingulate Inc.

Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR™ drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.

About Indegene

We are a digital-first, life sciences commercialization company. We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready. To learn more, please visit www.indegene.com

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature.

These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 28, 2022. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Investor Relations:

Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
[email protected]
(913) 942-2301

Matt Kreps
Darrow Associates
[email protected]
214-597-8200

Media Relations:

Melysa Weible

Elixir Health Public Relations
[email protected]
201-723-5805

Yadunandan K V

Director – Corporate Communications, Indegene
[email protected]

CING-US-120-0324

Presentations at the 38th Annual European Association of Urology Congress Reinforce
Low Surgical Retreatment of the UroLift^® System

WAYNE, Pa., March 13, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced new research from controlled and real-world studies of the Prostatic Urethral Lift (PUL) procedure with the UroLift^® System, for treating men with benign prostatic hyperplasia (BPH). Results underscore the benefits of early intervention with respect to durability, symptom improvement and sexual function that urologists around the world have come to expect from the UroLift^® System, which is the leading minimally invasive, outpatient treatment in the United States for enlarged prostate.¹ The research was presented at the 38^th Annual European Association of Urology (EAU) Congress taking place in Milan from March 10-13, 2023.

“These important new analyses show that, whether compared to other interventions or medication, the UroLift^® System offers unique benefits that make it the treatment of choice for many men searching for long-term relief of burdensome BPH symptoms,” said Jacqueline Welch, Vice President, Global Clinical and Scientific Operations, Teleflex.

Following are key findings from the studies:

Results from over 330 PUL subjects studied in a controlled setting

<sup>2


,3</sup>

• PUL with the UroLift^® System was durable in most subjects at one and five years. Lower durability at one year is associated with undertreatment (≤4 implants placed).² Lower durability at five years is affected by poor baseline obstructive symptoms indicated by the International Prostate Symptom Score (IPSS).²
• Earlier treatment in the disease continuum (i.e., better IPSS and quality of life (QoL) scores at baseline) positively impacts quality of life outcomes. Similarly, treatment with the UroLift^® System prior to severe erectile dysfunction in sexually active patients predicts the likelihood of a patient achieving meaningful change in the Sexual Health Inventory for Men (SHIM) assessment.³

Comprehensive patient experience results of obstructive median lobe (OML) subjects treated with PUL

⁴

• In responder analysis utilizing the novel BPH6 study endpoints (relief of symptoms, quality of recovery, preservation of sexual function, preservation of continence and safety),** UroLift^® System OML and lateral lobe patients responded consistently.⁴
• Compared to Transurethral Resection of the Prostate (TURP) done in lateral lobes, UroLift^® System OML subjects achieved superior quality of recovery and preservation of ejaculatory function. Additionally, only these TURP subjects experienced high-severity adverse events.⁴  

Outcomes from the largest healthcare utilization study for BPH therapies, including medication

⁵

• Approximately 6% of medical therapy patients underwent BPH-related procedures through 1 year as the disease progressed.⁵ 
• Procedure complication rates were similar between TURP, Photoselective Vaporization of the Prostate (PVP) and Aquablation^®, and lowest for PUL with the UroLift^® System. Although the Aquablation^® data were relatively immature because of the newness of the technology, the complication rate (~20%) indicates a safety profile similar to more invasive treatments.⁵

“The research presented at EAU reinforces the UroLift^® System as an effective and durable BPH solution, backed by meaningful quality of life data that support a superior patient experience,” said Steven Gange, M.D., F.A.C.S., of Summit Urology Group and Associate Medical Director of the Teleflex Interventional Urology Business Unit. “The results from these studies emphasize the value of the UroLift^® System in successfully treating BPH symptoms, enabling rapid recovery, preserving sexual function, and improving patients’ overall quality of life.”^2-5

About the UroLift

^®

System

The UroLift^® System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift^® permanent implants, which can be delivered during an outpatient procedure,⁶ relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift^® System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.⁷ It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.*^8-10 The 5-year L.I.F.T. study results demonstrate UroLift^® System durability with a surgical retreatment rate of about 2-3% per year and 13.6% total over 5 years.⁸ Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.¹¹ Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift^® System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. More than 400,000 men have been treated with the UroLift^® System in select markets worldwide.¹² Learn more at www.UroLift.com. Rx only.

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Contacts:

Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
Investors.teleflex.com
610-948-2836

Media:
Nicole Osmer
[email protected] 
650-454-0504

*No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study

** Individual elements of the BPH6 composite endpoint assessed the following: 1) LUTS improvement; 2) Quality of Recovery; 3) Preservation of Erectile function, 4) Preservation of Ejaculatory function; 5) Continence preservation; and 6) Safety

References:

1. U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness
2. Roehrborn, et al, EAU 2023. Durability following treatment with the Prostatic Urethral Lift (PUL): Predictors from over 330 controlled subjects across 5 distinct studies. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
3. Barber, et al, EAU 2023. Patient characteristics and dynamic variables predictive of meaningful quality of life and sexual function improvement after Prostatic Urethral Lift (PUL). [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
4. Eure, et al, EAU 2023. Patient experience outcomes are consistent between men with median and lateral lobe obstruction following treatment with the Prostatic Urethral Lift (PUL). [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
5. Kaplan, et al, EAU 2023. The Impact of BPH Care: Procedural Complications Associated with MIST and Traditional Surgery Compared to Disease Progression with Medical Therapy. [Conference Presentation] Study sponsored by Teleflex Incorporated or its affiliates
6. Shore, Can J Urol 2014
7. Rukstalis, Prostate Cancer and Prostatic Dis 2018
8. Roehrborn, Can J Urol 2017
9. AUA BPH Guidelines 2003, 2020
10. McVary, Urology 2019
11. Roehrborn, J Urology 2013
12. Management estimate based on product sales as of December 2022. Data on file Teleflex Interventional Urology.

Teleflex is the home of Arrow^®, Deknatel^®, LMA^®, Pilling^®, QuikClot^®, Rüsch^®, UroLift^®, and Weck^® – trusted brands united by a common sense of purpose.

Teleflex, the Teleflex logo, Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners.

© 2023 Teleflex Incorporated. All rights reserved. MAC02656-01 Rev A