Biotech and healthcare stocks saw notable activity in Friday's after-hours trading session, with several names posting sharp moves on the back of corporate updates and investor anticipation. Here are the highlights from November 21, 2025.Butterfly Network, Inc. (BFLY) shares climbed in extended trading, rising 6.04% to $2.81 after adding $0.16. At the close, the stock had already surged 14.22% to $2.65. The digital company announced that CEO Joseph DeVivo and Interim CFO Megan Carlson will participate in a ...

Financial Data and Key Metrics Changes - Iterum generated net product sales of $0.4 million in Q3 2025, which included initial stocking at specialty pharmacies [21] - Total operating expenses were $8.1 million in Q3 2025, compared to $4.9 million in Q3 2024, reflecting increased commercialization activities [21][22] - The net loss on a US GAAP basis was $9 million for Q3 2025, compared to a net loss of $6.1 million for Q3 2024 [24] Business Line Data and Key Metrics Changes - The launch of Orlyvah began on August 20, 2025, with over 280 prescriptions generated by more than 100 unique prescribers by November 12, 2025 [9][12] - Approximately 40% of Orlyvah prescriptions have been filled through payer approval processes, aligning with expectations [10] Market Data and Key Metrics Changes - Orlyvah's access now reaches 16% of insured lives, with increasing adoption by employer groups and payer formularies [16] - A signed rebate agreement with a top Medicare Part D pharmacy benefit manager allows Orlyvah to be added to formularies for coverage beginning in 2026 or 2027 [15] Company Strategy and Development Direction - The company plans to raise additional capital to support ongoing commercialization efforts and potentially expand into high-value territories [19] - Iterum aims to generate revenue in excess of expenses and become self-funding over the next couple of years [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the feedback from physicians, payers, and patients regarding Orlyvah, indicating a positive trajectory for revenue growth [20] - The company expects modest sales in Q4 2025 and anticipates net product revenue for 2026 to be between $5 million and $15 million [18] Other Important Information - Iterum's cash and cash equivalents at the end of September 2025 were $11 million, providing an operating runway into Q2 2026 [24][25] - The company has reduced its in-person field team to 10 representatives and is augmenting efforts with virtual sales representatives [14] Q&A Session Summary Question: Will the company report specific launch metrics in the coming quarters? - The company plans to report metrics such as prescriptions, growth, and number of physicians to track the launch [27][28] Question: Can the company provide more details on payer coverage and uptake? - Feedback from physicians has been positive, particularly regarding Orlyvah's ability to keep patients out of the hospital [31][32] Question: What marketing strategies are being considered to drive uptake? - The company is focusing on field organization investments and is considering social media and other marketing channels for future engagement [40][52]

Commercialization of ORLYNVAH™ - ORLYNVAH™ was commercially launched in the United States in August 2025, with modest sales expected during the early stages of commercialization efforts[166]. - The commercialization partner EVERSANA will provide sales and commercial operations services for ORLYNVAH™ under a five-year agreement[168][169]. - The company plans to continue commercialization efforts for ORLYNVAH™ and expand its research and development programs, which will require additional capital[243][246]. - The company has limited net product sales to date since the launch of ORLYNVAH™ in August 2025, with revenues expected to fluctuate in future periods[182]. - Product revenue for the three months ended September 30, 2025, was $0.4 million, compared to $0.0 million for the same period in 2024, reflecting the launch of ORLYNVAH™ in August 2025[198]. - For the nine months ended September 30, 2025, product revenue was $0.4 million, up from $0.0 million in 2024, driven by ORLYNVAH™ sales[208]. Financial Performance and Losses - The company incurred net losses of $20.4 million and $18.2 million for the nine months ended September 30, 2025 and 2024, respectively, and an accumulated deficit of $506.5 million as of September 30, 2025[172]. - The company expects to continue incurring significant expenses and increased operating losses as it focuses on maximizing the commercial potential of ORLYNVAH™[167]. - The operating loss for the three months ended September 30, 2025, was $7.7 million, compared to a loss of $4.9 million in 2024, an increase of $2.8 million[197]. - Loss before income taxes for the nine months ended September 30, 2025, was $20.1 million, compared to a loss of $18.0 million in 2024, an increase of $2.1 million[207]. - Total operating expenses for the three months ended September 30, 2025, were $8.1 million, an increase of $3.2 million from $4.9 million in 2024[197]. - Total operating expenses for the nine months ended September 30, 2025, were $17.4 million, an increase of $2.3 million from $15.0 million in 2024[207]. Cash Position and Funding - As of September 30, 2025, the company had cash and cash equivalents of $11.0 million, raising substantial doubt about its ability to continue as a going concern[176]. - The company had cash and cash equivalents of $11.0 million as of September 30, 2025, but does not believe this will cover operating expenses for the next 12 months, raising substantial doubt about its ability to continue as a going concern[243][244]. - The company sold 11,875,589 ordinary shares under the Sales Agreement at an average net price of $1.07 per share, generating net proceeds of $12.7 million[220]. - The company registered for sale up to $150.0 million of various securities under the 2025 Shelf Registration Statement, effective February 19, 2025[219]. - During the nine months ended September 30, 2025, net cash provided by financing activities was $2.2 million, primarily from the sale of ordinary shares and the April 2025 Registered Direct Offering[241]. - The company generated net proceeds of approximately $42.1 million from the February 2021 Underwritten Offering, which included the sale of 2,666,666 ordinary shares[233]. Expenses and Cost Management - Selling, general and administrative expenses increased significantly to $6.5 million for the three months ended September 30, 2025, compared to $1.8 million in 2024, an increase of $4.7 million[202]. - Research and development expenses decreased to $1.3 million for the three months ended September 30, 2025, from $3.1 million in 2024, a reduction of $1.8 million[201]. - Research and development expenses for the nine months ended September 30, 2025, were $2.9 million, down from $9.2 million in 2024, a decrease of $6.3 million[211]. - Personnel related costs decreased by $0.3 million due to a reduction in accrued bonuses, while professional and consulting fees increased by $8.2 million, primarily for pre-commercialization and commercialization activities[212]. - The company anticipates increased expenses due to inflation and a competitive wage environment, which may affect future operating costs[245]. Strategic Planning and Future Outlook - The company is continuously evaluating corporate, strategic, financial, and financing alternatives to maximize value for stakeholders[178]. - The company is actively considering contingency plans, including alternative sourcing strategies, to mitigate potential future impacts from increased tariffs and trade tensions[249]. - The company is evaluating corporate, strategic, financial, and financing alternatives to maximize shareholder value while managing resources prudently[251]. Regulatory and Market Considerations - The company received FDA approval for ORLYNVAH™ on October 25, 2024, for the treatment of uncomplicated urinary tract infections[225]. - The company is obligated to pay Pfizer sales milestones upon achievement of net sales ranging from $250.0 million to $1.0 billion for each product type, as well as royalties ranging from single-digit to mid-teens percentage based on marginal net sales of each licensed product[252]. - Payments to holders of RLNs will be due within 75 days of the end of each six-month payment measuring period, with a payment rate of 15% based on specified net revenues from U.S. sales of sulopenem products[254]. - The company has agreements with contract service providers that represent significant costs in research and development and commercial activities[253]. - The new reciprocal tariff rates range from 10% to 41%, with imports from Switzerland receiving a 39% rate, while the baseline tariff on China remains at 10%[248]. - The company may face a 100% tariff on all branded or patented drugs imported into the U.S. starting October 1, 2025, unless manufacturing facilities are built in the U.S.[248]. Foreign Currency and Inflation Impact - The company has not engaged in any hedging activities against foreign currency exchange rate risk, and realized net foreign currency gains and losses did not materially affect operations[257]. - Inflation has not had a material effect on the company's financial statements to date, but future operations may be adversely affected by inflation[258]. - The company experienced a net cash decrease of $13.1 million for the nine months ended September 30, 2025, compared to an increase of $7.3 million in the same period of 2024[237].

Product Launch and Sales - Iterum Therapeutics launched ORLYNVAH™ in the United States in August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs) after over 25 years without new branded launches in this space[3] - Net product revenues for the third quarter of 2025 were $0.4 million, reflecting initial sales of ORLYNVAH™[7] - The company expects net product sales of ORLYNVAH™ to range between $5 million and $15 million in 2026, depending on market uptake and payer coverage[3] Financial Performance - The net loss for the third quarter of 2025 was $9.0 million, compared to a net loss of $6.1 million for the same period in 2024[13] - Product revenue for the three months ended September 30, 2025, was $390 million, with no revenue reported for the same period in 2024[25] - The net loss for the three months ended September 30, 2025, was $8,979 million, compared to a net loss of $6,094 million for the same period in 2024, indicating a 47% increase in losses[25] - Non-GAAP net loss for the three months ended September 30, 2025, was $7,342 million, compared to $4,837 million for the same period in 2024, reflecting a 52% increase[25] Expenses - Research and development expenses decreased to $1.3 million in Q3 2025 from $3.1 million in Q3 2024, primarily due to lower chemistry, manufacturing, and control expenses[10] - Selling, general, and administrative expenses increased to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, attributed to the commercialization of ORLYNVAH™[11] - Total operating expenses for the three months ended September 30, 2025, were $8,121 million, compared to $4,887 million for the same period in 2024, representing a 66% increase[25] - Research and development expenses for the three months ended September 30, 2025, were $1,261 million, compared to $3,107 million for the same period in 2024, showing a decrease of 59%[25] Cash and Assets - Cash and cash equivalents were $11.0 million as of September 30, 2025, with an extended cash runway projected into Q2 2026[6] - Cash, cash equivalents, and short-term investments decreased to $11,002 million as of September 30, 2025, down from $24,125 million as of December 31, 2024[27] - Total assets decreased to $32,503 million as of September 30, 2025, from $44,595 million as of December 31, 2024[27] - Total liabilities decreased to $39,884 million as of September 30, 2025, from $48,676 million as of December 31, 2024[27] Shareholder Information - The company reported a weighted average of 45,801,927 ordinary shares outstanding for the three months ended September 30, 2025, compared to 20,044,270 for the same period in 2024[25] Intellectual Property and Research - Iterum has been granted a patent in China for a combination treatment related to sulopenem, projected to expire in March 2041[4] - The company presented two posters at the IDWeek 2025 conference, highlighting its focus on urinary tract infections[5] Derivatives and Amortization - Adjustments to the fair value of derivatives for Q3 2025 were $0.7 million, compared to $0.4 million for the same period in 2024[12] - The amortization of intangible assets for the three months ended September 30, 2025, was $349 million, with no amortization reported for the same period in 2024[25]

Core Insights - Iterum Therapeutics has commercially launched ORLYNVAH™ in the United States in August 2025, targeting uncomplicated urinary tract infections (uUTIs) [1][2] - The company has extended its cash runway into Q2 2026, with cash and cash equivalents reported at $11.0 million as of September 30, 2025 [1][4] - The company anticipates modest sales for ORLYNVAH™ in 2025, with expected net product sales ranging between $5 million and $15 million in 2026 [2] Financial Performance - Net product revenues for Q3 2025 were $0.4 million, primarily from initial stocking at specialty pharmacy locations [5] - Research and development expenses decreased to $1.3 million in Q3 2025 from $3.1 million in Q3 2024, attributed to lower chemistry, manufacturing, and control expenses [9] - Selling, general, and administrative expenses increased to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, driven by the commercialization of ORLYNVAH™ [10] Loss and Adjustments - The net loss for Q3 2025 was $9.0 million, compared to a net loss of $6.1 million in Q3 2024 [12] - Non-GAAP net loss for Q3 2025 was $7.3 million, compared to a non-GAAP net loss of $4.8 million in Q3 2024 [12][14] - Adjustments to the fair value of derivatives for Q3 2025 were $0.7 million, up from $0.4 million in Q3 2024 [11] Product and Market Development - ORLYNVAH™ is positioned as a novel oral penem antibiotic with potent activity against resistant strains of bacteria, addressing a significant unmet need in the uUTI market [18] - The company has expanded its patent estate, receiving patents in China and Mexico for formulations related to ORLYNVAH™, with expiration dates projected in 2041 and 2039, respectively [7] - Iterum presented at the IDWeek 2025 conference, highlighting its commitment to addressing antibiotic resistance and promoting ORLYNVAH™ [7]

Earnings Reports Overview - The earnings season is slowing down, but several retail-favorite companies are set to report this week [1] - Key companies reporting include Barrick Mining Corp., Plug Power Inc., Oklo Inc., Cisco Systems Inc., Walt Disney Co., and Applied Materials Inc. [2][3][5][10][11] Company-Specific Insights - Barrick Mining Corp. reported its third-quarter results before the market opened on November 10 [2] - Plug Power Inc. is expected to report losses of 12 cents per share and revenue of $179.54 million, having missed earnings expectations for the last 18 quarters [3] - Oklo Inc. is anticipated to report losses of 13 cents per share and revenue of $17.01 billion, with stock volatility noted ahead of the report [5] - Cisco Systems Inc. is expected to be a focal point for investors, particularly regarding management's guidance and updates on AI and cybersecurity business momentum [10] - Walt Disney Co. and JD.com Inc. will release earnings reports before the market opens on November 13 [11] - Applied Materials Inc. is set to release its Q4 results after the market closes on November 13 [11] Additional Companies Reporting - Other companies reporting this week include Workhorse Group Inc., Beyond Meat Inc., Microvision Inc., and Virgin Galactic Holdings Inc. [4][6][12]

Core Insights - Iterum Therapeutics plc is set to release its third quarter 2025 financial results on November 14, 2025, before the U.S. markets open, followed by a conference call at 8:30 a.m. ET to discuss the results and business updates [1] Company Overview - Iterum Therapeutics plc focuses on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [3] - The company is advancing its first compound, sulopenem, which is a novel penem anti-infective with both oral and IV formulations, showing potent in vitro activity against various resistant bacteria [3] - Iterum has received FDA approval for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women, along with QIDP and Fast Track designations for its formulations in seven indications [3]

Core Insights - Iterum Therapeutics plc is focused on developing next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens in both community and hospital settings [1] Group 1: Conference Participation - The company will present two posters at the IDWeek 2025 conference in Atlanta, GA from October 19-22, 2025 [1] - A Learning Lounge session titled "An Overview of Urinary Tract Infection in Adult Women: Focus on Oral Sulopenem" will be conducted on October 21, 2025 [2] - The two posters include: 1. "Risk factors for treatment failure in patients with uncomplicated urinary tract infection" presented by Steven I. Aronin, MD on October 20, 2025 [2] 2. "In vitro activity of sulopenem and comparator agents against U.S. Enterobacterales clinical isolates, SENTRY antimicrobial surveillance program, 2023" presented by Steven I. Aronin, MD on October 21, 2025 [2] Group 2: Product Information - ORLYNVAH™ is a novel oral penem antibiotic specifically designed for treating uncomplicated urinary tract infections (uUTIs) [3] - ORLYNVAH™ is effective against Enterobacterales species that produce extended spectrum beta-lactamases (ESBL) or AmpC-type β-lactamases, which confer resistance to third-generation cephalosporins [3] Group 3: Company Overview - Iterum Therapeutics plc aims to address the global crisis of multi-drug-resistant pathogens with differentiated anti-infectives [4] - The company is advancing sulopenem, a novel penem anti-infective compound, which has shown potent in vitro activity against various resistant bacteria [4] - ORLYNVAH™ has received FDA approval for treating uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited treatment options and is commercially available in the U.S. [4]

Core Insights - Iterum Therapeutics is focused on developing next-generation oral and IV antibiotics to combat multi-drug resistant infections in both community and hospital settings [1] Financial Overview - As of June 30, 2025, Iterum expects its cash and cash equivalents, along with $2.2 million raised from its at-the-market offering, to fund operations into 2026 [3] - The company is exploring various financing opportunities, including non-dilutive funding, to extend its operational runway [3] Product Launch and Market Access - ORLYNVAH™, an oral antibiotic, was launched in August 2025 in targeted territories across seven U.S. states, with sales representatives actively engaging with physicians [5] - The product is broadly accessible via prior authorization and medical exception pathways, with ongoing discussions for expanded access and long-term formulary positioning [5] - Iterum has received 510(k) clearance from the FDA for its Antimicrobial Susceptibility Test Disc, aiding in effective therapy for patients [5] Patent Developments - Iterum has been granted a patent in China for a combination treatment, projected to expire in March 2041, and a patent in Mexico for a bilayer tablet, set to expire in December 2039 [6] - The company is optimizing its patent strategy to ensure the expansion of its valuable patent portfolio [6] Upcoming Events - Iterum will conduct a Learning Lounge at IDWeek 2025 on October 21, 2025, focusing on urinary tract infections in adult women [6] Company Overview - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens with its lead compound, sulopenem, which has shown potent activity against various resistant bacteria [7] - ORLYNVAH™ has received FDA approval for treating urinary tract infections caused by specific bacteria in adult women with limited treatment options [7][8]

Core Viewpoint - Iterum Therapeutics has launched ORLYNVAH™, the first oral penem antibiotic in the U.S. for treating uncomplicated urinary tract infections (uUTIs) in women, addressing a significant unmet medical need in the face of rising antibiotic resistance [1][5]. Group 1: Product Launch and Approval - ORLYNVAH™ (sulopenem etzadroxil and probenecid) received FDA approval in October 2024 for adult women with uUTIs caused by specific pathogens [1][5]. - This product is the first new branded treatment for uUTIs in over 25 years, providing a critical option for patients with limited oral antibacterial alternatives [1][5]. Group 2: Market Need and Impact - Approximately 60% of women experience a urinary tract infection in their lifetime, with 44% having three or more episodes annually, highlighting the prevalence of this condition [2]. - The increasing resistance to antibiotics is expected to inflate healthcare costs and lead to poor patient outcomes, emphasizing the urgent need for new therapies [2]. Group 3: Clinical and Patient Benefits - Clinicians have expressed that ORLYNVAH™ offers impressive efficacy data and a much-needed treatment option for women suffering from difficult-to-treat uUTIs [3]. - The introduction of ORLYNVAH™ is anticipated to reduce emergency department visits and hospital admissions, positively impacting patients' quality of life [3]. Group 4: Company Mission and Future Plans - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens by developing differentiated anti-infectives [5]. - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its formulations, indicating a strong commitment to innovation in this therapeutic area [5].